_CPJE 2018 Finalized_
When to send a written report of child/elder abuse/neglect incident?
2 working days or 36 hours to law enforcement.
After approved waiver, how long do CS rx records need to be stored in the pharmacy before moving off-site?
2 years
Naloxone documentation must be kept for a minimum of....
3 years.
Nicotine Replacement documents kept for....
3 years.
How long should controlled substance inventory records be kept
3 yrs from taking of inventory
How long should pharmacy technician compliance records be kept
3 yrs from time of making
Daily limit for ephedrine-like products
3.6 grams
How many CE hours are pharmacist required to have for renewal?
30
Time to notify board of discontinuation of drug take back service
30 days
Rx Refills (CIII-CIV)
4-5-6 rule for refills (excludes original fill) - Max 4mo (120 days) supply of refills - Max 5 refills - 6mo expiration from date on rx
requirements to dispense contact lenses
- requires valid rx - rx dispensed must be for the *exact contact lenses ordered* - *no substitions allowed* - direct pt to eyecare practitioner for any problems or reactions - *pharmacy must register with Medical Board of California*
Pregabalin
(Lyrica) C.V
Nalbuphine
(Nubain) (not a C.S.)
Pharmacists can turn patient's 30 day supply into a 90 day supply if they satisfy the following conditions:
1) It is a non-controlled medication *and not a psychiatric medication* 2) The patient has completed an initial 30 day supply without adverse effects. 3) The quantity filled does not exceed the quantity prescribed (authorized) 4) The provider is notified of the change.
Diprivan **1. discoloration 2. peanut or soy allergy 3. incompatible with ca Used for sedation in ICU, rapid anesthesia induction, short procedures. Less postoperative nausea than thiopental. Potentiates GABA-A
*Propofol*
new self assessment survery
- every odd number year by July 1st - within 30 days of a new pharmacy permit - within 30 days of change in PIC
Self Assessment Survey
- every pharmacy must complete before *July 1* of every *odd numbered year* by PIC - reviews pharmacy compliance with fed and state laws - if sterile drug compounding, need separate self-assessment - keep in pharmacy for 3 years
How are c2 to be inventoried?
- exact accounts must be done
Expiration dates on rx label
- exact date from manufacture or - 1 year
Exceptions for overtime
- executive or administrative capacity (does not include PIC or pharmacy manager) - employees adopt by a 2/3rds vote an alternative workweek at no longer than 10 hours per day and 40 hours per week - in cases of emergency or where need to protect life - employee works 40 hours a week while working part-time at another pharmacy (each pharmacy is a separate entity and not responsible for additional work at a second or third pharmacy)
faxed Rx
- for *non-scheduled rx only* - must produce hard copy for filing if control rx is faxed -must be reduced to writing and call prescriber to verify
time period for use of single-dose ampules
- for IMMEDIATE use only
Representative in Charge for wholesalers
- required and approved by BoP - must ID new RIP within 30 days of RIP leaving - temporary license for up to 180 days if change in wholesaler ownership
What are the CE requirements for furnishing nicotine replacement products?
2 hours every 2 years
What are the CE requirements for furnishing travel medicine?
2 hours every 2 years
Civil action
individual has been harmed or injured by the actions of a pharmacist parties involved: individuals compensation: money
Tech check tech
NOT operational in every hospital or community pharmacy program. Can only occur in acute hospitals that have an ongoing clinical pharmacy program where pharmacists are in the patient care areas
Incidental Disclosures
NOT part of HIPAA violation
Humulin N, Novolin N=Novolin L, Humulin L. Insulin Zinc
NPH=Lente: intermediate-acting insulin; cloudy; injection SC 60 mins before meals; can mix NPH with rapid or short-acting
Pentobarbital
Nembutal CII
Stelara
Ustekinumab (Immunosuppressive drug. It can treat plaque psoriasis and psoriatic arthritis)
Schedule II security rx to be sent by prescriber to pharmacy pursuant to an emergency oral order by prescriber
Within 7 days from date written. CII written by PA must be reviewed and countersigned by MD!!!
Chapter 17, Title 16 of the california code of regulations from sections 1700 - 1793.8 cover what?
more meaning and depth to issues of pharmacy practice
when can a hospital with 100 beds or less dispense to outpatients:
directly by physician: - best interest of pt - no other pharmacy available or accessible in 30 mi radius or within 30 minutes - no more than 72 hour supply - properly labeled and dispensed by prescriber
time period for use of multi-dose container
discard within 28 days of initial opening or puncture
amphetamine
dyanavel, evekeo c 2
Rx Transfers (CII)
Cannot transfer
Prescription Storage
Keep prescriptions for 3 years *If waiver for offsite storage, then - Keep non-controls for 1 year on site, 2 years off site - Keep controls for 2 years on site, 1 year off site
Optometrists prescription key points.
Limited to 10 days of oral acyclovir Limited to 3 weeks of topical antiviral medication Can only give Zithromycin for eye lid infections or chlamydial infestations of the eye.
Submitting dispensing data to CURES
weekly
potency definition
within +/- 10% of the labeled amount
Upon closure of a pharmacy, a transfer of drugs notice must be provided to the BOP
within 10 days of the closure, and must be in writing
Required consultation when rx is mailed or delivered
written notice of pt's right to request consultation including: - telephone number to call in order to obtain oral consultation
patient medication profile
1 year
Must keep CE records for?
4 years.
Certificates of CE course completion
4 yrs from date of course completion
Interns can do anything a pharmacist can do except...
Have a key to the pharmacy.
Droxia, Hydrea
Hydroxurea (treat leukemia and head and neck cancer.)
Schedule 5 drugs...
Lyrica Lomotil codeine containing cough syrups.
Taxotere=Taxol/Onxol/Paxene
Taxanes: *Docetaxel**=Paclitaxel* no PVC tubing
When using terminally ill as exception for anything, prescriber needs to write what on rx?
"11159.2 exception"
How long must DEA Form 222 order records be kept on file for inspection?
"3 years (B&PC §§ 4801,4105, 4333)"
required auxiliary labels for conotrols
"it is a crime to transfer this drug to any person other than the patient for whom the drug was prescribed"
Max amount that may be charged as an administrative fee in addition to the cost of an emergency contraceptive agent (no admin fee may be charged if OTC on Plan B)
$10
Maximum amount that may be charged as an administration fee in addition to the cost of an emergency contraceptive agent
$10
Duloxetine
(Cymbalta)
Valium
(diazepam) C.IV
KADIAN® Extended-Release Capsule
(morphine sulfate Extended-Release Capsule
Pharmacist in Charge can supervise up to...
*2 pharmacies* as long as they are within *50 driving miles. *
Bactrim DS(UTI); Septra
*Sulfamethoxazole/Trimethoprim(400/80; 800/160)*: 1.take with food and water to prevent stomach issue and crystaluria(kidney stone);2. photosensitivity for all sulfa antibiotics 3. D5W only+no refrigerator+protect from light 4. 2C8/9 inhibitor>increase INR warfarin 5. serious skin rash 6. preg-C
AndroGel=Testim=Fortesta(1% shoulders and arms), Androderm(back, abd, thighs or arms QHS. remove during MRI), Axiron (topical sol: underarms after the deodorant), striant buccal tabs
*Testosterone* CIII with MedGuide: 1. DOC male hypogonadism, sexual dysfunction in M&F and hot flashes in F 2. Preg-X 3.SE: hyperlipidemia, prostate/breast cancer, hepatotoxic, ^wt, worsen BPH
Armour Thyroid, Thyrolar, Cytomel=Triostat, Levothroid=Levoxyl=Synthroid=Unithroid
*Thyroid Desiccated*(120mg daily natural thyroid made from animal gland T3+T4) , *Liotrix(T3+T4), Liothyronine(T3), Levothyroxine(T4)* 1. BBW: ineffective and toxic if used for wt loss 2. Safe in pregnancy 3. Cardiotoxic 4. IV:PO=1:2 5. DDIs with cholestyramine, Ca/Mg/Al, Iron, sucralfate>seperate by 2hrs 5. 30mins before bf with a full glass of water in the morning 6. Keep in a temprature and humidity-controlled environment 7. Levothyroxine: mix with NS. Mix on the floor prior to administration. IV push. add 5 ml NS to vial
Vivotif Berna(live, po)=Typhim Vi(inactivated, IM)
*Typhoid Vaccine* 1. refrigerator 2. no alcohol(destroy the EC) 3. take with water on D1,3,5,7 4. finish 1 week before trip
Varivax
*Varicella*: chickenpox, SC, freeze, live attenuated>avoid in pregnancy/weakened immune system/HIV CD4<200
Zostavax
*Zoster*: shingles, live attenuated, SC, >=60yo, freeze, avoid in pregnancy/weakened immune system/HIV CD4<200, you can get chickenpox from a person with active zoster infection, we can still vaccinate if pt has had shingles(wait 6 mos)
training requirements for furnishing nicotine replacement products
- 2 hour CE on smoking cessation training once every 2 years
A single pharmacist on duty may have the following ancillary personnel working at any given time:
- 2 interns - 1 tech - any reasonable number of clerks addition RPh may have 2 additional techs
Plan B for OTC
- 2 tablets of levonorgestrel 0.75mg each - 1st tab taken within 72 hours, 2nd tab within 120 hours - *only sold in pharmacies* - may be sold by clerk - sold to *17 yo +* - may purchase more than 1 package - no administrative fee - no consultation required -
Emergency Supply of control 3-5
*only reaonable quantity* until prescriber can be contacted
CA Security Prescription Form Requirements
- "VOID" appears when scanned/copied - Chemical void protection - Watermark on back of rx that reads "California security prescription" - Thermochromic ink - Area of opaque writing so writing disappears if rx is lightened - Description of security features on each rx - Six qty CHECK BOXES printed on form with 1-24, 25-49, 50-74, 75-100, 101-150, 150 and over - Space to designate units if drug not in cap/tab form - Statement: "Prescription is void if the number of drugs prescribed is not noted" - Preprinted name, category of licensure, license number, DEA number of prescriber - CHECK BOXES for refill number - Date of issue - CHECK BOX indicating MD order not to substitute - Identifying number assigned to approved security printer by DOJ - CHECK BOX by name of each MD when rx form lists multiple MDs Lot number is printed on each form Controls and NonCS can be written on same security form
training requirements for furnishing naloxone
- *1 hour CE* or - be trained in equivalent curriculum-based program in pharmacy school
Blood Clotting Product Provider Requirements
- 24/7 on call services - Be able to obtain all FDA approved blood clotting products in multiple assay ranges and vial sizes - Supply infusion equipment and supplies with each rx prn - Ship products and supplies to pts w/in 2 business days
Chart Order Record Keeping
- 3 years for non-CS - 7 years for CS
CE requirements
- 30 hours every 2 years - retain for 4 hours - after July 1, 2018 new RPh must take at least *6 hours* in one or more of teh following subjects: 1. emergency/disaster response 2. pt consultation 3. maintaining control of pharmacy drug iniventory 4. ethics 5. substance abuse/red flags and RPh corresponding responsibility 6. compounding
Brand to Generic
- Generic must be cheaper than brand - Communicate switch to patient - Do not sub if DAW1
US territories?
- Guam - Virgin Islands - American Samoa
Faxed CIII-V
- MD manually signs REGULAR rx before faxing - If MD uses security form, VOID will show up on pharmacy rx, and pharmacy will have to verify *Pts cannot fax rx's
Who can we dispense epi pens to?
- Pre-hospital emergency med care person - Lay rescuer - Authorized entity for first aid purposes - School district/charter school based on MD written order *Responder needs certification demonstrating training
Emergency Refills Without the Prescriber's authorization are allowed if:
- The prescriber is unavailable - The Patient's well-being will suffer if medication therapy is interrupted -The pharmacist has tried to contact the prescriber Must document the refill Prescriber must be notified.
When do pharmacy permits need to be renewed?
- annually - new owner
Which drug used for treatment of narcotic addiction can be used for greater than the 30 day period?
- methadone - levoalphacetylmethadol (LAAM)
requirements for rph handling and furnishing radioactive drugs
- rph must be specifically trained in these areas through nuclear pharmacy course and/or gained experience approved by Board
requirements for use of automated drug delivery systems in SNF and intermediate care facilities
- written policies and procedures - emergency drug may be retrieved from system pursuant prescriber orders and drug must be reviewed by rph within 48 hours - must be properly labeled - rph shall review or approve all orders prior to drug being removed - access to automated delivery system shall be controlled and tracked using ID or password system or biosensor - personnel training required - does not require rph to be physically present if rph surveys the system electronically - rph responsible for stocking, upkeep, and general monitoring
APh 1. Required for license 2. Can do the following services independently
-Complete residency program -Provided clinical services >1yr under CPA -Earn certificate in relevant area (oncology, critical care, pharmacotherapy, etc)
How long must a patient medication profile be kept on file for inspection?
1 year following last dispensing date (CCR § 1707.1)
What to do after self-assessment is complete?
-Create action plan to correct any non-compliance. -Keep form on file (do not send it anywhere) for 3 years
How long must a pharmacy keep the QA review on file after investigation?
1 year from date it was created (CCR § 1711[f])
Expiration date for products produced by the drug manufacturer?
1 year or exact expiration date from manufacturer
Med Guides required for these classes of drugs -impaired ability to drive when taken with alcohol
-Muscle relaxants -Analgesics with CNS depressant effects -Antipyshcs (including phenothiazines) -Antidepressants -All C2-C5 -Anticholinergic
Expiration date for extemporaneous unit dose preparations
1 yr or less if manufacturer's expiration date is less than 1 year
Expiration date for any compounded rx
6 months or less (if any ingredient expires before)
All new rx must be counseled on by a pharmacist. Exceptions, if a patient is in (3)
-a healthcare facility -an adult care facility -juvenile detention facility
What orders can be transmitted to pharmacist via phone? and by whom?
-non-scheduled -C5 -C4 -C3 -by nurse/secretary. RPh must document who called.
What is the refillable zone for c3-5?
6 months, not to exceed 12 days on the issued refills
Update BOP with email
-within 60 days of becoming licensed and -within 30 days of changing email address.
What is the CE hours requirement for the 1st license pharmacist renewal after graduation?
0 hours (B&PC § 4231)
Telepharmacy 1. Supervising pharmacy can supervise ___ remote pharmacies 2. Supervising pharmacy is within ___ miles away. 3. Nearest pharmacist is ___ miles away. 4. Can only dispense ___ rx per day (on ave per calendar year) 5. Consultation?
1 .one 2. 150 road miles. 3. > 10 road miles 4. 225 rx per day 5. Supervising pharmacist consults on every rx (new and refills)
ratio of pharmacy technicians to pharmacist
1 RPh to 1 Tech for the 1st tech - Any additional pharmacist may now have 2 additional tech (total of 3 techs for 2 RPh)
Must report to DEA within how many days any loss/theft of controlled substances
1 business day
California Smoking Hotline for behavioral changes?
1-800-NO-BUTTS
Optometris (OD) 1. License distinction 2. Prescribe controlleds?
1. "T" end of the license number 2. codeine- and hydrocodone- and tramadol- containing meds for a max of 3 day supply
Medications with MedGuides -10 categories, with #10 being other: -Warfarin, fentanyl, raloxifene, tamoxifen, tacrolimus, teriparatide, testosterone
1. Antidepressants (SSRIs, SNRIs, etc) 2. NSAIDs 3. Insomnia 4. LABA 5. ADHD drugs 6. Diabetes drugs (Exenatide, Actos, Rosiglitazone) 7. Antipsychotics: abilify and seroquel only 8. Antiarrhythmics: amiodarone only 9. Retinoids: isotretinoin, aceitretin (Soriatane) 10. Others
During inspections, if CS Rx are removed by officer/investigator 1. they must give pharmacist a ___ 2. Pharmacy should do what? (copy or original)
1. receipt 2. Pharmacy should make copy of Rx and keep duplicate; give original to the officer/investigator
Dispensing drugs during a federal, state, local emergency 1. What drugs can be dispensed 2. What needs to be recorded 3. Mobile pharmacy
1. Both controlled and non-CS in reasonable quantities 2. Record of date, pt's name, address, drug information must be maintained + make good faith effort to communicate information to patient's HCP 3. Must share common ownership with at least one currently licensed pharmacy, retain records of dispensing, reasonable security measures, located within declared emergency area, ceases activity within 48 hours after emergency is over
Naloxone 1. Must do what if administered naloxone 2. Pharmacist must have 3. Keep records of furnishing naloxone for how long
1. Call 911 2. completed 1 hour of CE or curriculum based training, ask if receipient uses opioids or knows someone who does, provide counseling (CANNOT be waived), fact sheet, notify Pt's PCP 3. 3 years
Traditional Compounding Exemptions
1. Don't have to comply with FDA's CGMPs 2. Don't need to label with sig 3. Don't need to complete NDA
How to become an advanced practice pharmacist (APh) 1. Must meet 2 of the following 3 requirements 2. If working with controlled substances, APh must be registered with ____
1. Earn certification in a relevant area of practice: amcare, critical care, oncology, etc 2. complete a post-grad residency program 3. Provide clinical services to patients for one year (at least 1,500 hours) under a collaborate practice agreement or protocol -DEA
Notice to Consumers must include these 4 things are available
1. Easy to read type for prescription drug labels 2. Interpreter services 3. Drug pricing 4. Generic drugs
Med Guides 1. Approved by? 2. Written by? 3. When to provide to patients? (5)
1. FDA 2. Mfg 3. -Every time (new AND refills) dispensed in outpatient setting. -Every time the pt will use w/o supervision of HCP. -First time drug is being dispensed to a HCP for admin to a pt in the output setting -When pt/caregiver asks for it -if MedGuide has been revised
Patient Package Insert 1. Approved by? 2. When to provide to patients (outpatient) 3. When to provide to patients (inpatient) 4. If not provided per (2) and (3) 5. why provide?
1. FDA 2. All estrogen-containing drugs (new AND refills) 3. All estrogen-containing drugs (before admin of first dose and Q30 days) 4. Considered misbranding. 5. VTE risk
Written patient information 1. Consumer Medication Information (CMI) leaflets 2. Patient Package Inserts (PPIs) - reviewed and approved by FDA 3. Medication Guides (MedGuides) - reviewed and approved by FDA
1. For each NEW prescription 2. Must be given for estrogen containing drug (if not provided, it is misbranding) -Everytime (initial fill and refills) for outpatients; in HA, give before administration and every 30 days 3. Many Rx drugs with sig health concerns: REMS, antidepressants, antipsychotics, anticonvulsants, LABA, most antiarrhythmics, NSAIDs -Provided by the drug manufacturer -Must be given every time (initial fill and refills)
Tech License
1. High school graduate OR GED equivalent AND 1 of the following 1. Associate's degree in pharmacy tech 2. Completed board approved training 3. Graduated from pharmacy school recognized by board 4. Completed board approved cert program accredited by National Commission for Certifying Agencies (PTCB and NHA programs)
Travel Meds 1. Requirements to furnish 2. Notify patient's PCP of drugs dispensed within ___ of furnishing
1. Immunization certificate, completion of approved travel medicine training program (at least 10 hours of some book), complete CDC's Yellow Fever Vaccine Course, have current BLS, completed 2 hours of CE 2. 14 days
Oral CII Rx
1. In certain emergencies, RPh can fill CII to tide pt over until valid rx received 2. If pt is a resident of licensed SNF, intermediate care facility, home health agency, or hospice
Emergency Contraceptives 1. Preferred if <72 hours; preferred if >= 72 hours 2. OTC one tab vs 2 tab 3. Rx 4. Protocol option 5. Can EC be furnished for future use and is there a quantity limit
1. Levonorgesterol, high dose BC pills; ulipristal (Ella, more effective from 3-5 days) 2. One tab: no sex, age, or ID requirements Two tab: only 17+ and must be kept behind pharmacy counter 3. Under ACA, EC is covered with a prescription written for A FEMALE 4. Pt may choose if she does not have a Rx and wishes to use insurance coverage. Pharmacist must have completed 1 hour of CE on EC to furnish. Provide EC Fact sheet, record on med record, counsel 5. Yes, no
Name Tags
1. Must always wear at work 2. 18-point type 3. Name 4. License status
Natruopathic doctors (ND) 1. Prescribe meds 2. Prescribe controlleds?
1. Must use "furnishing number" to prescribe: "NDF" beginning of their license number 2. Even under dependent authority, can only prescribe C3-C5
3 types of legal actions
1. civil action 2. Criminal action 3. administrative action
Allergic conjunctivitis: 1. OTC: *Naphazoline/pheniramine, Ketotifen* 2. Rx *Levocetirizine=Emedastine*(Antihist) *Ketorolac*(NSAID) *Cromolyn=Nedocromil*(Mast cell stabilizers) *Azelastine=Olopatadine**Loteprednol* (steroid) eye drops; Dry Eyes: 1. Artificial tears: *systane, refresh, clear eyes, Liquifilm* 2. *Cyclosporine Emulsion*: provides benefit for a small % of users and is expensive; MedGuide; use immediately after opening PinkEye: Rx *Azithromycin*(refr, RT for 14 ds) *=Moxifloxacin=Besifloxacin=Tobramycin/Dexamathasone=ciprofloxacin=Ofloxacin=Gentamicin=Tobramycin=Trimethoprim/polymixin=Neomycin/bacitracin/polymyxin*
1. Naphcon-A/Opcon-A/Visine-A, Zaditor/Alaway 2. Xyzal=Emadine, Acular, Alocril, Optivar=Patanol, Lotemax; 1. Restasis; Azasite=Vigamox=Besivance=XX=Ciloxan=Ocuflox=Garamycin=Tobrex=Polytrim=Neosporin
1. Roxicodone, Oxenta, 2. Xtampza ER, Oxycontin 3. Percocet, Endocet; Roxicet 3. Percodan
1. Oxycodone 2. ER 3. +APAP 3. +aspirin CII
What four things MUST be together on the prescription label and MUST take up 50% of the sticker?
1. Patient Name 2. Drug name and strength 3. Directions of use 4. Purpose of drug 12 point sans serif
DPI Dry powder inhaler- Diskus, capsules, twist-cap
1. Priming not required 2. Do not shake 3. Use mouthpiece (No spacers!) 4. Inhale dose fast and deep 5. Do not inhale into diskus 6. Rinse mouth 7. Do not clean. Keep it dry
DUR Types
1. Prospective DUR - Eval of pt's med profile before dispensing 2. Retrospective DUR - Review of drug therapy after drug is dispensed - Used to detect and correct inappropriate prescribing patterns, or fraud/abuse
Rx must have these 8 + what if for a pet
1. Pt name 2. Pt address 3. Drug/device name and quantity 4. Directions for use 5. Date of issue 6. Prescriber information - name, address, phone, license classifcation, DEA (if CS) 7. Condition or purpose of prescribed drug, if requested by patient 8. Prescriber's signature -If for pet: + kind of animal and name and address of owner
1. 503A 2. 503B 3. To be a registered 503B facility:
1. Traditional compounding (make a product *after* receiving rx) 2. aka, outsourcing facility. Prepares compounded meds in bulk without a rx written for an individual pt. 3. MUST compound sterile drugs for humans.
Clerk Roles
1. Type rx label 2. Enter rx info into computer 3. Request/receive refill auths 4. Put drugs back on shelf 5. Give pts rx's at register *Can NOT pull drugs
1. "should" 2. "shall"
1. a recommendation 2. you must do
REMs drugs include what 4 things
1. communication plans 2. implementation plans 3. elements to assure safe use (ETASU) 4. MedGuides
Eligibility requirements for California Outsourcing Facilities and 503b
1. engage Sterile drugs for humans 2. CGMP 3. Inspected by the FDA
Frequency 1. Controlled substances inventory 2. Self-assessment form 3. Pharmacist continuing education (30 hours) 4. Submitting dispensing data to CURES 5. Medication error investigation
1. every 2 years 2. every odd-number year before July 1st + within 30 days, when there is a new pharmacy permit, a change in PIC, or change in pharmacy location 3. every 2 years, except first cycle 4. Weekly 5. Within 2 days of error
Dispensing blood clotting products for home use 1. For what pts 2. Provider for blood clotting products should
1. hemophilia and von Willebrand dx 2. maintain 24/7 call service & acknowledge all calls within 1 hour; be able to ship prescribed blood clotting products and ancillary infusion equipment to pt within 2 business days
General Clinics
1. non-profit community clinic 2. free clinics 3. non-profit multispecialty clinic
Notifications for the Board - timeframe 1. Establishment of drug take back service 2. D/C of drug take back service 3. Any tampering with a collection bin 4. Theft of deposited drugs 5. Any tampering, damage, or theft of a removed liner 6. Disclosure of service and location of each receptacle
1. within 30 days 2. within 30 days 3. within 14 days 4. within 14 days 5. within 14 days 6. Annually, at time of facility license renewal
How many different C2's can be ordered on a single DEA 222 form?
10 - only 1 item per line, 10 lines per form
How long does a pharmacy have to respond to a Notice by the Board?
10 days
Pharmacy to report to CABOP of losses due to theft, self-use, or diversion by a board licensee.
14 days
Report theft by or impairment of a licensee by
14 days
Byetta(BID with meal;need needle)/Bydureon(weekly)=Victoza
1st GLP-1 Agonist: *Exenatide(renal)=Liraglutide*: 1. peptide analogs; insulin secretagogues>>+response to a meal(^insulin, -glucagon), delay gastric emptying; 2. inject weekly: Bydureon/Exenatide; Albiglutide/Tanzeum;Dulaglutide/Trulicity; Semaglutide/Ozempic 3. CL cutoff 30: Lixisenatide/Adlyxin, +insulin/ Soliqua, Byetta/Bydureon 4. Pro: weight loss 5. SE: GI, pancreatitis BBW: thyroid tumors 6. refri and RT for 30 ds
Blood clotting agents 1. Notifies patient of Class 1 or Class 2 recall of blood clotting agents/ancillary infusion equipment within....
24 hours of receiving notice
Invokana=Farxiga=Jardiance
2nd line SGLT-2 inhibitor-G reabsorptions from prox. renal tubule(renal): *Canagliflozin*(100mg)*=Dapagliflozin*(10mg, bladder/breast cancer)*=Empagliflozin*(10mg): 1. new drug>wt loss 2. yeast infection, UTIs, MOA dependent on renal function-avoid if GFR<60
Contraceptive Screening by pharmacists must be kept for....
3 Years.
Time MD has to countersign nurse's order
48 hours
If not physically present at the time of prescribing, a prescriber has what time frame to countersign the order of an inpatient in the chart or medical record within a hospital?
48 hours (CCR § 70263[g])
Maxipime
4th: cefepime (IM/IV): c. diff; preg B, cross sensitivity
Teflaro (IV)
5th: Ceftaroline: MRSA
How many BoP members must be non-pharmacist?
6
Controlled Substance expiry in California?
6 months
Expiration date for compounded products?
6 months
How long are c3-5's valid for?
6 months
How long is a C3-5 Rx valid for?
6 months
Submit data to CAIR (CA Immunization Registry) after administration of vax
<14 days
Child Resistant Packaging
<80% of children <5YO cannot open it BUT >90% of adults can open it New container and closure must be used for each rx dispensed - If glass container, then replace top closure - Pt may request easy open caps with blanket waiver - MD may request waiver for 1 rx at a time OTC products can dispense easy open products as long as there is a CR product available too - Easy open products must carry warning that it is NOT rec'ed in households with kids CR requirements do not apply if drug is administered directly by HCP to inpt
Substituting Brand for generic and the *Orange Book* A=? B=?
A= Therapeutically equivalent B= Not therapeutically equivalent. Second letter is the type of drug formulation
DEA License Types
A, B, F, G: Hospital, clinic, practitioner, teaching institution, pharmacy M: Mid level practitioner (nurse, PA, optometrist) P, R: Manufacturer X: Opioid addiction treatment practitioners
Inventory requirement for controlled substances
ACTUAL count for ALL CII!!! Estimated count for CIII-V UNLESS bottle of > 1000 then need ACTUAL count. Records must be retrievable on premises for 2 years
NRTI (Emtricitabine/emtriva-refrigerater solution, RT*90D)
Abacavir; Emtricitabine;Lamivudine;TDF/TAF;Zidovudine
Epzicom (Qday)
Abavacir(NRTI 2nd line)+Lamivudine(NRTI)
ReoPro=Aggrastat=Integrilin #Glycoprotein IIB/IIIa receptor antagonist# *injection only, must filter, thrombocytopenia, hypotension, do not shake the vial*; only Abciximab is reversible and no renal adjust
Abciximab=Tirofiban=Eptifibatide(refri, RT for 2 ms, protect from light)
Clerks in California can...
Accept prescriptions at the drop-off very patients insurance overage type prescriptions ring up patients at the prescription pick-up window
Flunisolide
Aerospan, Aerobid inhale
Notice Requirement by board & response to notice by licensee
After notice licensee must respond within 10 days
Praluent=Repatha
Alirocumab=Evolocumab: PCSK9 inhibitor, SC q2wks, adjunct to statin therapy
t-PA, Activase=r-PA, Retavase=TNK-tPA=Streptase=Abbokinase
Alteplase=Reteplase=Tenecteplase=Streptokinase=Urokinase: Fibrinolysis (IV thrombolytics)
Entereg: peripherally acting Mu receptor antagonist; REMS for MI long term use; not for pt who has been on opioids for >7days （Gut motility stimulator）
Alvimopan
Aricept=Exelon=Razadyne=Cognex; Nameda
Alzheimer's disease: Donepezil(Qday, QHS to help nausea)=Rivastigmine(w/f, exelon daily patch if N/V)=Galantamine=Tacrine(not used d/t hepatotoxicity): Achesterase inhibitor caution: bradycardia, GI, risk of dizziness and falls; Memantine(IR w/o f; XR Qday w/f): NMDA Rec. Antag; Vitamin E, Gingko
Amobarbital injection
Amytal CII (sedative-hypnotic)
1. Vitmin B12, Folate 2. Ferrlecit=Niferex, Desferal=Dexferrum
Anemia: 1. Macrocytic/Megaloblastic/^MCV: *Cyanocobalamin* (IM,SC, PO,SL, Intranasal) *Folic Acid* (1 tab QD, OTC: 0.4/0.8mg, Rx 1mg tab; Meds decrease folate abs: phenobarbital, phenytoin, oral contraceptives, 6-MP, azathioprine, cholestyramine, methotrexate, primidone, thioguanine) 1. 2. Microcytic/decrease MCV: Iron deficiency (25%cases) *Ferric gluconate*(IV if HD, increase risk of anaphylactic Rxs) *Triferic*(27.2mg iron/5ml delivered via dialysate for CKD) *Ferrous Sulfate*(325mg daily TID or 160mg if CR tabs slow fe) *Iron polysaccharide* 1-2tabs BID; 1-2 caps daily; SEs: GI upset, nausea, constipation, dark stools *Deferoxamine* (IM, IV, No EC/SR tabs initially; ^iron abs>acidic ph; decrease Iron abs: avoid food and abxs) *Iron Dextran Complex* IV(only when oral therapy is not an option; hypersenditivity/anaphylactoid reactions)3. Normocytic/chronic anemia/acute blood loss: bone marrow failure, hemolysis, chemo, immunosupressants; ESA use only if anemia is life-threatening, use the lowest dose to avoid need for RBC transfusion. Prescribers/hospitals must enroll to ESA APPRISE oncology programs to use ESA with cancer pts.
Questions required to ask before giving Nicotine replacement therapy
Are you pregnant? If yes, do not give. Heart attack in last 2 weeks? May give, but refer to PCP History of palpitations, irregular heartbeat, or arrhythmia? May give but refer to pcp. Frequent chest pain? may give but refer to pcp. History of allergic rhinitis? Give, avoid spray History of TMJ? give but avoid gum.
How many times may a nonscheduled RX be transferred to different pharmacies?
As many times as there are refills
Non-controlled prescriptions can be transferred ...
As many times as there are refills.
Saphris (schizophrenia and acute mania associated with bipolar disorder)
Asenapine SL (touch numbness)
Mometasone
Asmanex Nasonex- nasal)
Novolog Mix 70/30, 50/50=Humalog75/25, 50/50=Humulin 70/30, 50/50 & Novolin 70/30
Aspart protamine sus/aspart=Lisopro protamine sus/lispro=NPH/regular: cloudy
How long should patient medication profile records be kept
At least 1 yr from date of last entry. NON CONTROLLED meds must be maintained on premises
Depakene/Stavzor=Depakote=Lamictal=Keppra=>Topamax=>Klonopin=>XX=>Zonegran
Atypical absence myoclonic, atonic: *Valproate or valproic acid=Divalproex=Lamotrigine=Levetiracetam=>Topiramate=>Clonazepam=>Felbamate*(Hepatotoxicity, -OC, aplastic anemia)*=.Zonisamide*
CANNOT own pharmacy/get license to own if
Authorized to prescribe Shares a community or financial interest in the permit Any corp that is controlled by or a person has > 10% stock (except an inpatient hospital pharmacy that is owned by the hospital that it is located in)
Stendra (erectile dysfunction) PDE-5 Inhibitor increases cellular cGMP levels leading to vasodilation
Avanafil
Zithromax; azasite (eye drop): once opened can be left at RT for 14 days, discard; empty stomach for ER suspension (do not refrigerate d/t thicken & bitter taste) only; QT-prolongation; preg B
Azithromycin; Gram+/-, atypical, anaerobes(pneumonia), hepatic 3A4: inhibitor for all mycins CATE)
Azactam
Aztreonam class 2g IV q8h. Renal. Ok with PCN allergy
Cali prescribers can self-prescribe for themselves, and family if...
It's non-controlled and there's a good faith exam for the family members.
Amiodarone
BW: pulmonary, hepatotox Warn: hyper/hypothyroidism, optic neuropathy, photosensitivity SE: hypoTN, bradycardia, corneal microdeposits, dizziness, ataxia, N/V, constipation, tremor MedGuide, protect from light, non-PVC, filter
CLINDAMYCIN
BBW C. diff COLITIS Pregnancy Cat B Do NOT refrigerate Cleocin)
PIC must complete biennial pharmacy self assessment form...
Before July 1st of each odd numbered year.
Oral Systemic Corticosteroids
Betamethasone = Dexamethasone 0.75mg Methylprednisolone = Triamcinolone 4mg Prednisone = Prednisolone 5mg Hydrocortisone 20mg Cortisone 25mg
clarithromycin
Biaxin) Metallic taste 1 g daily with/out food, but XL tab Take with food
DEA requires that controlled substances inventory be done
Biennially (Every other year)
Ziac
Bisoprolol/HCTZ
CLIA waived tests --> pharmacy needs to obtain valid CLIA certificate of waiver and register with the CA Department of Public Health (CDPH) - 3 tests
Blood glucose A1c Cholesterol tests
Briviact (C-V) a racetam derivative with anticonvulsant properties
Brivaracetam
CIII Butisol, Butibel
Butabarbital
BUPRENORPHINE
C.III Buprenex inj, Subutex, Butrans patch)
heroin
C1 and no bn
When does CURES reporting only need to be monthly?
C2-3 with 48 hour supply or less
Counting Opened CS Containers
CI-II need exact count CIII-V - Bottles of 1000 or less can be estimated - Bottles >1000 require exact count
Apomorphine shedule
CII in California but not a schedule federally
Federal Warning Label for CS
CII-IV needs "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed."
What schedule is ketamine
CIII both in California & federally
*Yasmin, Yaz, Beyaz* popular since they decrease bloating, PMS symp. and wt. gain, d/t the progestin drospiremone (K-sparing diuretic)
COC: *Monophasic* Yasmin, April, Femcon Fe, Loestrin, Low-ogestrel; Demulen, Ortho-Cyclen, Ovcon, Ortho-Novum, Necon, Desogen *Bi-Phasic* Kariva, Micrette Ortho-Novum *Tri-Phasic*Otho Tri-Cyclen, Cyclessa, EstroStep, Triphasil, Tri-Norinyl, Ortho-Novum *Four-Phasic* Natazia *24days* Yaz, Beyaz *3-mos* Seasonale, Seasonique *12 mos* Lybrel *Patch* Ortho Evra (1 patch/wk*3 and 1 wk off; higher level of estrogen>nausea) "NuvaRing" insert once monthly : PPI 1.*BBW* >35 yrs who smoke, which increases the risk of CV, risk increases with number of cigs 2. DDIs: use a backup method if taking Rifampin, ABT, Anticonvulsants, St. John's wort, anti-retrovirals
Oral prescriptions for CII Cannot be...
Called in except for an emergency.
OTC EC
Can be purchased OTC w/o sex, age, or ID requirements - Some generics require 17+YO Two tab levonorgestrel products have age restriction and are kept behind teh counter
Emergency Dispensing
Can dispense without rx in declared emergencies - Need record containing date, pt's name, pt's address, drug name, drug strength, drug qty, drug device - RPh needs to make good faith effort to communicate emergency fill to provider
Primaxin; Merrem; Invanz(NS only); Doribax
Carbapenems: Cilastatin/Imipenem; Meropenem; ertapenem; doripenem: Gram+/-; anaerob; PSA(expcept invanz); renal toxicity; seizure risk; preg B(C for primaxin); cross sensitivity
Soma
Carisoprodol C-I
Coreg, Coreg CR **with food
Carvedilol
Nabilone (CII CINV)
Cesament
Lubiprostone (Amitiza) (Rx)
Cl- Channel Activator) 24mcg bid with food. For chronic idiopathic constipation and opioid-induced constipation
cefotaxime
Claforan
Persistent diarrhea
Cleocin Broad-spectrum abx
Cleviprex DHP CCB **peanut or soy allergy
Clevidipine
Cleocin **persistent diarrhea
Clindamycin Hcl: not macrolides; Gram+; 450mg w/o f; BBW: C. diff; preg B; no refri; topical fir acne
Lotrisone; Gyne-lotrimin-7/Mycelex-7=Monistat-1/3/7=Mycostatin=Femstat-3/Gynazole-1=Vagistat-1=Terazol(cream)/Zazole(supp)
Clotrimazole/Betamethasone D;intravaginal(OTC) topical azoles for 1,3,7 d regimen(ok for pregnancy): Clotrimazole= Miconazole= Nystatin tab insert= Butoconazole= Tioconazole= Terconazole Cream
REMs
Clozapine Isotretinoin Qsymia Forteo Addyi Saxenda, Symlin Thalidomide ER/LA opioid analgesics (CIQFASTE)
Rx Format Requirements
Cluster the below into one area that compromises at least 50% of label in 12-point sans serif typeface in the following order 1. Patient name 2. Drug name and strength (+ manufacturer if generic, and + "generic for ___" if generic) 3. Sig 4. Condition or purpose if on rx *Highlight in bold or color or use blank space to set off these items
Cocaine
Cocaine c 2
Codeine
Codeine c 2
Phenergan with codeine
Codeine/Promethazine CV
Duavee
Conjugated estrogens/Bazedoxifene
What should pharmacist do if MD fills scheduled medication incorrectly
Contact MD for clarification. Make correction on security RX. Document changes & note that it was authorized by MD. NOT required that MD send new security RX.
Name tag
Contains their name License status 18-point type
Lubricants (OTC)
Contraindicated in pregnancy Mineral oil (Nujol) 6-8 hrs. S.E.: ↓ vitamin absorption and bleeding risk with chronic use
Prescribing for Family
Controlled AND non-controlled substances okay as long as MD/PT relationship is valid, legit med purpose, good faith exam
General Emergency Refill
Controlled substance EXCEPT CII may be refilled w/o MD authorization if MD unavailable & pharmacist's professional judgment. Refill ONLY reasonable amount to maintain patient until MD available. RECORD on reverse side of RX: date & quantity given, note MD not available, & judgment for dispensing
Who retains what copy of the DEA 222 form?
Copy 1 (Brown): retained by the supplier Copy 2 (Green): sent to the DEA by the supplier at the end of every month Copy 3 (Blue): retained by the pharmacy receiving the drugs
222 Triplicate
Copy 1Brown-Seller/Manufactor/Sender. Copy 2Green-DEA Copy 3-Blue- Pharmacy/Receiver
Delsym, Bromfed(DM), Mucinex
Cough: Antitussive *Codeine, Diphenhydramine+Dextromethorphan* *Bromoheniramine/pseudoephedine/dextromethorphan* (proof of age 18) Expectorant: *Guaifenesin* a full glass of water and maintain hydration: 1. Do not use antihistamines, OTC cough and cold products in children<4y. Use saline sprays(Ocean) 2. Preg: Chlor-Trimeton, Benadryl, Zyrtec, Xyzal, Allegra, Claritin, Nasalcrom, steroid sprays. Avoid decongestants. 3. Topical menthol and camphor(Vick's VapoRub) dont work well and should not be used if <2 yo
Mast Cell Stabilizer►
Cromolyn sodium (Intal) (anti-inflammatory) prevent both early/late response to allergens For exercise-induced give 15min prior exercise/For allergen-induced use prior to exposure 2-4 inhalations q6-8h (MDI); 20mg q6-8h (NEB) Minimal S.E. (unpleasant taste, cough) but less effective than inhaled corticosteroids
Seromycin TB
Cycloserine
CSOS vs DEA 222
DEA 222 - 10 items max - Schedule I, II only - Receive order in 1-7 business days - Handwritten sig from POA - Order can be endorsed to another supplier - Supplier reports transaction to DEA by end of month CSOS - No order limit - All nonscheduled and schedule - Receive order in 1-2 business days - Digital sig from POA - Order can NOT be endorsed to another supplier - Supplier reports transaction to DEA in 2 business days *Must order C2 through 222 or CSOS *Can order C3-5 on 222, CSOS, or purchase order
How does a pharmacy transfer c2s to another prescriber (or another pharmacy)?
DEA Form 222 - pharmacy acts as the supplier --> maintains copy 1 - pharmacy sends copy 2 to the DEA - prescriber's office maintains copy 3
Emergency Refills (CII)
DO NOT DO IT Maybe with at least emergency verbal order obtained - MD needs to provide original rx by 7th day following fill date with "Authorization for Emergency Dispensing" on face and date of oral rx. RPh attaches that to emergency oral rx. If not received, report to CA bureau of narcotic enforcement w/in 144hrs and DEA
Pradaxa(po):keep in original container for 4m=argatroban(IV/SC)=bivalirudin/angiomax=desirudin/iorivask
Dabigatran: direct thrombin inhibitor; no routine monitoring; renal adjust <30; stroke ppx with AFib, DVT/PE; reverse by Idarucizumab(Praxbind) 5mg IV or activated charcoal if last dose <2 hrs
Methylphenidate (ADHD)
Daytrana patch
No pharmacist shall compound any drug that is...
Deemed unsafe by the FDA or that is commercially available unless stated on ASHP or FDA to be in short supply. In this case you need to save documentation for 3 years.
Who has independent authority to prescribe limited to their scope of practice
Dentist Podiatrist (DPM) Veterinarians (DVM) Optometrist (OD) - License ends in T Naturopathic doctors (ND) - License begins with NDF* Pharmacists (PharmD, baby!)* * = can have dependent authority for all other non-controlled medication and schedule II-IV drugs
Certified Nurse-Midwife (CNM) Prescribing Authority
Dependent authority *all other non-CS, C2-5* *Must register with DEA for CS
Nurse Practitioner (NP) Prescribing Authority
Dependent authority *all other non-CS, C2-5* *Must register with DEA for CS
Physician Assistant (PA) Prescribing Authority
Dependent authority *all other non-CS, C2-5** *Must register with DEA for CS
Pristiq (Antidepressant)
Desvenlafaxine
Dexpak
Dexamethasone
Depakote ER, Depakene, Depacon**avoid pregnancy
Di valproex Sod ER
Metamucil, Imodium, Lomotil, Pepto-Bismol/Kaopectate
Diarrhea: *Psyllium*(to soak up liquid) *Loperamide*(start 4mg, followed by 2mg after each loose stool>>max 16mg/d) *Diphenoxylate/Atropine* (C-V 1-2 tab QIAC, not for <2 year old) *Bismuth Subsalicylate* (avoid if salicylate allergy, black tongue&stool also treats indigestion, stomach ulcers)
Dynapen
Dicloxacillin(oral): : renal toxicity, Preg B; --birth control; beta-lactams for Gram(+)
stimulant drug of the phenethylamine, amphetamine, and cathinone classes that is used as an appetite suppressant. It is used in the short-term management of obesity, along with dietary and lifestyle changes
Diethylpropion (Tenuate) C-IV
Motofen Antiperistaltic
Difenoxin/Atropine C-IV
Digox; cause yellow halos if toxic
Digoxin: 1. essential Tx of AF with warfarin; HF increase exercise tolerance and improve s/sx; 2. 0.125-0.25mg QD and -25% when converting to IV; first sign of toxicity are N/V, loss of appetite, bradycardia, blurred or yellow vision(halos), abdominal pain, confusion>>antidote: digibind or digifab; 3. monitor trough levels (CHF: 0.5-0.9; AF: 0.8-1.2), SrCr, maintain K>4 and Mg>2
Norpace(empty stomach)=(empty stomach, BBW: agranulocytosis, Lupus erythematosus)=(take w/f, BBW: increase mortality, thrombocytopenia, SE: diarrhea, strong anticholinergic>>cinchonism, DDI: decrease digoxin dose by 50%, warfarin, grapefruit, verapamil etc. )
Disopyramide=Procainamide=Quinidine: class 1a
Pre/Post Dating
Do NOT do it Must date and sign on date when issued
doripenem
Doribax
Monodox, Oracea, Periostat, Doryx, Vibramycin;**for malaria PPX, take daily until 4 wks after travel**no in pregnancy, children<8, photosensitivity+protect from light
Doxycycline
Americaine Otic=A/B Otic/Auralgan=Floxin Otic=Cipro HC=Ciprodex=Cortisporin; Debrox=Cerumenex
Ear infection: *Benzocaine=antipyrine/benzocaine=ciprofloxacin=~+hydrocortisone=~+dexamethasone=Neomycin+hydrocortisone* Ear Wax removal: *Carbamide peroxide=Triethanolamine*
Sustiva(no food)
Efavirenz(NNRTI)
NNRTI
Efavirenz;Ripivirine
Med Expiration
Either 1. Expiration date on manufacturer container Or 2. ONE year from date drug is dispensed *If drug does not have exp date, then consider is misbranded and do not dispense
Zepatier
Elbasvir+Grazoprevir(HCV)
Theophylline
Elixophyllin, Theo-24, TheoCap, Uniphyl, Theochron bronchodilator) Narrow therapeutic range (5-20 mcg/mL) Requires monitoring of serum concentration levels. Multiple drug interactions!!
Viberzi IBD-D REMS for gallbladder obstruction; take with food; pancreatitis; sphincter of oddi spasm; CNS depression
Eluxadoline C-IV
Genvoya **take with food
Elvitegravir(INSTI)+Cobicistat(PI)+emtricitabine(NRTI)+TAF(NRTI)
Stribild
Elvitegravir(INSTI)+Cobicistat(PI)+emtricitabine(NRTI)+TDF(NRTI)
Fosaprepitant
Emend iv ( antiemetic)
Pharmacist can prescribe:
Emergency Contraception Hormonal contraception Travel Medicine Routine immunizations Naloxone Nicotine replacement.
All written C2-C5 drugs need to be written on CA Security Prescription forms. exceptions (2)
Emergency Use. Terminally Ill
Emtriva
Emtricitabine(NRTI)
Descovy(1st) （HIV）
Emtricitabine(NRTI)+TAF(NRTI)
Odefsey
Emtricitabine(NRTI)+TAF(NRTI)+Rilpivirine(NNRTI)
EES 400, EES Granules, EryPed 200
Erythromycin (Gut motility stimulator and antibiotics It can treat infections. It can also treat acne when used topically.); 400 mg po QID w/wt f; refri; QT-prolongation; preg-B
Estrace
Estradiol (It can treat symptoms caused by menopause or removal of the ovaries. It can also treat prostate and breast cancer, and prevent osteoporosis.)
Alora, Climara, Menostar, Minivelle, Vivelle-dot(for manopause symptoms and helps protect bone density, no need to remove for MRI) Fermring(vaginal ring)
Estradiol (transdermal patch)
premarin
Estrofens, conjudated
Lunesta Sleep Aid
Eszopiclone C-IV
Nuvaring
Etonogestrel/Ethinyl estradiol
Zortress(transplant); Afinitor(other cancers)
Everolimus (Chemotherapy)
Zetia
Ezetimibe: okay to + statins, but cause myopathy ie. Ezetimibe+simvastatin=Vytorin 10/40mg Qday
If an outsourcing facility is notified that a patient was harmed by a compound prepared by the facility, the facility must report the event to.... (1)
FDA MedWatch within 15 calendared days
REMS
FDA mandates REMS for certain drugs or biologics to ensure benefits outweigh risks 1. Communication plans 2. Implementation systems 3. Elements to ensure safe use (ETASU) 4. MedGuides
Novoseven RT
Factor VIIa recombinant
True/False: RPh may electronically enter a prescription for Xanax into a pharmacy's or hospital's computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital.
False! Can do this with non-controlled, but cannot do this with C2-C5.
Auryxia
Ferric citrate
can veterinary drugs be dispensed without a prescription
NO! law now authorizes vets to prescribe dangerous drugs thus requiring a prescription to be dispensed
Dificid
Fidaxomicin: C diff 200mg BID*10d=metronidazole=vanco(PO)=bactrim; use soap and water instead of alcohol;
Gilenya(EKG oral MS)
Figolimod (Immunosuppressive drug It can treat flare-ups of multiple sclerosis (MS))
If the CIII indicates that it may be refilled PRN then the pharmacist must respond to this by...
Filling original X, but unable to refilled the med until clarify with MD the number of refills (1-5 in 6 mo period). NO RX that is controlled is allowed to be PRN refills.
Schedule III
Fiorcet (not scheduled federally) Androgel APAP + Codeine Buprenorphine ketamine
Photosensitivity
Flagyl INH Retinoids Ritonavir & a few other HIV drugs Sulfa abx Tetracyclines NSAIDs Diuretics (FIRRST ND)
Ofloxacin; ciprofloxacin; levofloxacin; moxifloxacin(highest QT); gemifloxacin: gram+/-; atypical coverage; PSA; no need to take food; no refrigerate; MedGuide; BBW: tendon inflam/rupture(not 1st choice for <18yr); photosensitivity; hypoglycemia; crystalluria; seizure; C. diff; QT; preg-C; DDI with cations; inhibit CYP 450>>^INR warfarin; renal adjust except moxi; *respiratory fluoroquinolone
Floxin; cipro(lowest QT);levaquin*; avelox/vigamox*(B conjunctivitis); factive*
May mercury fever thermometers be sold OTC?
NO! requires a prescription
Medicare Part D
For 65+YO, <65 w/ disability, or ESRD
Kcentra
Four factor prothrombin complex (plasma for urgent warfarin reversa)
gamma-hydroxybutyric acid or GHB (the sodium salt form, sodium oxybate is c 3 )
GHB is c 1
Rx Refills (CII)
NOPE >:O
Lopid**30 mins before B&D
Gemfibrozil
SC Vax
Given into fatty tissue, usually fatty tissue above triceps - 5/8inch - 23-25 gauge - 45 degree angle
Mavyret
Glecaprevir+pibrentasvir (HCV)
Kytril, Sancuso(patch), sustol
Granisetron (CINV and post surgery NV)
Copy 2 of form 222?
Green - sent to the DEA by the supplier
(It can treat fungal infections such as ringworm, "jock itch," and athlete's foot) Give with meals-- especially high fat meals (anti-fungal) birth control less effective
Griseofulvin
intuniv(ADHD), Tenex:HTN
Guanfacine
Major cause: H. Pylori, NSAIDs, bisphosphonates
H. Pylori: 1. Triple: *LAC: Lansoprazole*+*Amoxicillin*(1g BID)+*Clarithromycin*(500mg BID) x10-14ds *BMT: bismuth+metronidazole+tetracycline x 14ds* 2. Quadruple: *Pylera: bismuth+metronidazole+tetracycline(QID)+1PPI BIDx10ds=PrevPac: Lansoprazole+amoxicillin+Clarithromycin(BID)x14ds=Helidac: Bismuth+Metronidazole+Tetracycline(QIDx14ds)+1 H2RAx28ds*
Authorized to transmit Rx to pharmacy via fax/phone - C3-C5
HCP or their nurse/secretary can trans min to a RPh. RPh must document who called.
HYSINGLA ER
HYSINGLA ER (hydrocodone bitartrate er
USP 800 is...?
Hazardous Drugs.
1. NIX=Elimite, RID 2. Natroba=Ovide=Ulesfia=Stromectol=Eurax
Head Lice: 1. OTC: *Permethrin*(1% lotion, >=2yo, may repeat in 7 ds, Elimite: 5% and needs Rx) *Pyrethrin* (one application shampoo, dose not have long lasting activity or kill lice eggs.) 2. Rx *Spinosad*(Topical susp. 4 yr. Nit combing and repeat applications NOT required. $$) *=Malathion*(6 yr+inflammable, careful hair dryer) *=Benzyl alcohol* (6 mo+) *=Ivermectin* (OTO tab, 15 kg+) *=crotamiton* *=Lindane*(not rcm'd neurotoxicity, MedGuide)
Tech licensure requirements
Highschool or GED + one of the following 1) Completed a *degree in pharmacy technology* 2) passed a *board approved tech course* 3) *graduated *from a school of pharmacy recognized by the board 4) Received *cert from PTCB*
Vistaril (anxiety, nausea, vomiting, allergies, skin rash, hives, and itching)
Hydroxyzine
Vistaril(short-term anxiety), Atarax antihistamine pruritis
Hydroxyzine
Maintain x least 7 yrs
Hospital pharmacy chart order records for controlled substances
Dilaudid, Exalgo ER(CL for naive pt)
Hydromorphone CII
Insulin/Glucose>Na bicarbonate>albuterol>furosemide>Kayexelate
Hyperkalemia
Tussinex schedule
II
Within how many days must the Board be notified in the case of bankruptcy, insolvency, or receivership?
IMMEDIATELY in writing
Exceptions to California Security Blank
If a terminally ill patient is expected to die in 1 year. * 11159.2 Exemption* Must be for pain control, symptom management, or both.
Notify CABOP of bankruptcy, insolvency, receivership
Immediately
Report bankruptcy, insolvency, receivership by
Immediately
Dentist Prescribing Authority
Independent authority *non-CS, C2-5* *Must register with DEA for CS
MD/DO Prescribing Authority
Independent authority *non-CS, C2-5* *Must register with DEA for CS
Podiatrist (DPM) Prescribing Authority
Independent authority *non-CS, C2-5* *Must register with DEA for CS
Vet (DVM) Prescribing Authority
Independent authority *non-CS, C2-5* *Must register with DEA for CS
Optometrist (OD) Prescribing Authority
Independent authority, limited to scope of practice - Register with board of optometry to prescribe (licenses will have *letter T at the end*) - For codeine containing drugs, limited to 3 day supply *Must register with DEA for CS
Lantus
Insulin Glargine
InFED
Iron Dextran (test need)
Bidil
Isosorbide dinitrate+Hydralazine: ISDN for HF; black pt add-on; decrease mortality; SE: lupus-like syndrome, HA, dizziness, reflex tachycardia
Imdur**no alcohol
Isosorbide mononitrate
Corlanor#the symptomatic management of stable heart-related chest pain and heart failure not fully managed by beta blockers.#HCN blocker in heart to -HR##**luminous phenomena-seeing flashes of light**
Ivabradine
CURES Program
Jan 1 2007 requires that CII, III, & IV be transmitted electronically to the central govt info data base on a weekly basis
Arava (Antirheumatics) DERM**avoid pregnancy (Immunosuppressive drug It can treat rheumatoid arthritis in adults)
Leflunomide
Fusilev
Leucovorin or levoleocovorin （enhance efficacy of flourouracil）
CII (treatment of opioid dependence)
Levo-alph-acetylmethadol (LAAM, long acting methadone, levomethadyl acetate)
levo-alpha acetyl methadol or laam
Levo-alpha acetyl methadol or LAAM c 2
Mu receptor agonist; CII (Narcotic It can relieve pain)
Levorphanol
Levorphanol
Levorphanol c 2
Victoza(need needle), Saxenda(medullary throid carcinoma, acute pancreatitis>>REMS)
Liraglutide(injection)
Xultophy
Liraglutide+insulin degludec
Prinzide, Zestoretic
Lisinopril/Hydrochlorothiazide
Prinivil, Zestril=Lotensin=Capoten=Vasotec=Monopril=Univasc=Accupril=Altace=Mavik
Lisinopril=Benazepril=captopril=enalapril=Fosinopril=Moexipril=Quinapril=Ramipril=Trandolapril: avoid NSAIDs
Adlyxin**GLP-1: SC daily 60 mins with meal
Lixisenatide
Imodium
Loperamide
Hyzaar
Losartan/Hydrochlorothiazide
Who has pure independent authority to prescribe
MD/DO
Authorized to prescribe CII-V drugs with DEA #
MD/DO Dentist DPM DVM Dependent authority: ND (III-V; NDF license #), RPh/PharmD, CNM, NP, PA
Mediation error/QA reports.
Maintained x 1 year.
CS Inventory.
Maintained x 3 years.
Letter T at the end of the license # on an optometrist...
Max 3 day supply of codeine-containing combinations and hydrocodone-combinations.
4th gen cephs
Maxipime
Isotretinoin
MedGuide REMS Blurred vision Photosensitivity
MUE
Medication Use Evaluation: A method that evaluates how medications are being utilized to treat patients in the hospital.
Upon closure of a pharmacy, a transfer of drugs notice must be provided to the board
Within 10 days of the closure, and must be in writing
Lariam(phychiatric seizures, arrhythmias, safe in preg and child, weekly for malaria PPX)
Mefloquine (treat and prevent malaria)
Namenda
Memantine Hcl
Methadose, Diskets, Dolophine CII
Methadone (BBW: QT prolongation>pro-arrhythmic if >200mg/day; hard to dose d/t variable t1/2, 40mg is for detox of opioid-addicted)
Medrol
Methylprednisolone
Mycamine **protect from light
Micafungin (t can treat infections caused by the Candida fungus)
Viibryd=Wellbutrin, Zyban for smoking cessation=Remeron
Misc for depression: *Vilazodone* (SSRI, 5-HT1A partial agonist, w/f, SE: dizziness, dry mouth, insomnia); *Bupropion*(SE. dry mouth, insomnia, Wt loss d/t appetite, max 450mg/d for seizure); *Mirtazapine* (geriatrics/oncology: helps w/sleep and increase appetite)>>low sexual SE
1. Imitrex(injection can be repeated once; tight or arm)/Treximet=Zomig=Maxalt=Relpax 2. Migranal 3. Fiorcet/Fiorinal 4. Topamax, Inderal, Blocadren, Elavil, Depakote 5. Frova
Migraine 1. *Sumatriptan /+Naproxen=Zolmitriptan PO/NS =Rizatriptan=Eletriptan* Serotonin 5-HT Agonists; avoid SSRIs and SNRIs; CL: w/MAOIs, celebrovascular disease or uncontrolled HTN 2. *Dihydroergotamine=Ergomar=Ergostat=Cafergot*(Preg-X, BBW: CL with CYP3A4 i: protease inhibitors, azole antifungals, and some macrolide antibiotics>toxic) 3. *APAP/ASA+Butalbital+Caffeine* C-III 4. *Topiramate, Propranolol, Timolol, Amitriptyline, Divalproex* PPX take daily 5. *Frovatriptan* DOC for acute tx of migraine HA
Leukotriene Rec. Antagonists
Montelukast (Singular) (age > 6 mo.) Once daily dosing Take 10mg hs since leukotriene is produced at night. Avoid in PKU (aspartame) Zafirlukast (Accolate) (age >5) 20mg BID empty stomach Zileuton (Zyflo CR) (age ≥12) 1200mg (2 tabs) BID within 1 hour of a meal Monitor liver 3rd line
If there is an ADC a PIC must check transactions every
Month
Roxanol(IR); (ER)MS condin; Kadian(can be opened and sprinkled); Arymo ER; Duramorph;MorphaBond ER; Infumorph(IV); Avinza (can be crushed and sprinkled); Embeda
Morphine Sulfate ; +Naltrexone CII(if morphine-group allergy, choose methadone, meperidine, fentanyl, tramadol, tapentadol)
suprep bowel prep kit
Na/K/Mg sulfate
Kava kava, Valerian, lemon balm, glutamine, passion flowers and hops, chamomile tea, theanine, skullcap
Natural products for anxiety:
Who is limited to only c3-5 drugs?
Naturpathic Doctors
Notify the board of any tampering with a collection bin (drug take-back)
Within 14 days
Prescribers can self-prescribe..
Non-Controlled substances for themselves.
Cardizem=Calan, Isoptin, Verelan, Covera
Non-DHP: Diltiazem=Verapamil: 1. CI: 2nd-3rd AV block, acute MI, BB use d/t bradycardia 2. Effective for arrhythmias over BB 3. preferred if CKD and diabetic nephropathy 4. SE. gingival hyperplasia, constipation(take docusate) 5. CYP 3A4 DDI
Can we deny patient services to someone who hasn't signed HIPAA?
Nope.
Sprintec 28
Norgestimate and ethinyl estradiol
Tri-Sprintec-28
Norgestimate and ethinyl estradiol
Trinessa-28
Norgestimate and ethinyl estradiol
What is the maximum BUD for multi‐unit containers?
Not later than (a) exp date on manufacturer's label or (b) 1 year from date drug dispensed
Multiple CII scripts given to 1 patient
Ok & valid if meets all CII requirements & ONLY for max of 90 day supply
Internet Prescription
Okay if prescriber performed an exam
Benicar/HCT=Atacand=Teveten=Avapro(+HCTZ=Avalide)=Cozaar=Diovan=Micardis=Edarbi
Olmesartan/HCTZ=Candesartan=Eprosartan=Irbesartan=Losartan=Valsartan=Telmisartan=Azilsartan
Transferring CIII-V
Only 1x
Self-Prescribing
Only NON-controlled substances
Offer to Counsel
Only RPh and interns can do it RPh not required to counsel inpts but must provide discharge counseling
Faxed Prescriptions
Only if from prescriber's office
Form 222:
Ordering, distributing, transferring schedule 1 and 2 drugs.
Orbactiv(DDI INR)
Oritavancin (semisynthetic glycopeptide antibiotic)
Pharmacist:Staff Ratio
Outpatient 1 pharmacist: 2 interns 1 pharmacist: 1 tech (2nd pharmacist: 2 techs) - max 3 techs per 2 pharmacists. 1 pharmacist: 1 tech trainee (up to 120hrs) 1 pharmacist: infinity clerks Inpatient 1 pharmacist: 2 interns 1 pharmacist: 2 techs 1 pharmacist: 1 tech trainee (up to 120hrs) 1 pharmacist: infinity clerks
Plavix=Ticlid=Effient=Kengreal(IV)=Brilinta
P2Y12 Thienopyridine*Clopidogrel=Ticlopidine*(may cause life-threatening hematologic reactions, including neutrogenia, agranulocytosis, thrombotic thrombocytopenia purpura(TTP), and aplastic anemia)*=Prasugrel=Cangrelor=Ticagrelor*: only kengreal and brilinta are reversible and fastest onset(not a prodrug); MedGuide;
olopatadine HCL; seasonal allergic rhinitis
PATANASE
Aloxi (only HT3 antagonist for delayed CINV)
Palonosetron
Invega(PO), Invega sustennna(IM qmon), Invega Trinza (IM q3mon)
Paliperidone
paregoric
Paregoric c 2
Plegridy (SC q14D)
Peginterferon beta-1a (Anti-Inflammatory It can treat multiple sclerosis (MS)
DATA 2000
Permits physicians to prescribe and dispense CIII-V drugs to treat opioid addiction outside of opioid treatment clinic *CARA allowed qualified NPs and PAs to treat narcotic dependence too. Do not need to register to opioid tx program.
If Scheduled Drugs are involved in transfers you must collect...
Pharmacies DEA on the transfer form.
Can pharmacies accept the return of sharps from the public?
Pharmacies may accept the return of needles and syringes from the public IF CONTAINED IN A SHARPS CONTAINER
Faxed CII
Pharmacist can use this to fill but cannot dispense until receiving hard copy If from licensed skill nursing facility/intermediate care facility/home health agency/hospice, then OK to fill and dispense *Pts cannot fax rx's
State of emergency allowance
Pharmacist may furnish reasonable quantity (72 hours usually) of all RX including scheduled II-V & nonscheduled to a patient during state of emergency even if patient doesn't regularly fill RX at pharmacy IF good evidence that patient has been on med. LOG patient's information, information about drug, & MD information. Notify MD ASAP of dispension
Patient Consultation Regulation
Pharmacist or pharmacy intern must provide ORAL consultation to patient. If hospital discharge, someone other than pharmacist may provide discharge counseling to patient about new meds. When RX is delivered then responsibility of patient to request consultation. INCLUDE: directions, storage, importance of compliance, precuation & warning ADR
Flagyl
Photosensitivity Discoloration Do not refrigerate Protect from light
Tetracyclines
Photosensitivity May make birth control less effective Protect from light (doxycycline)
Bactrim
Photosensitivity Take with plenty of water Do not refrigerate Dextrose
Salagen
Pilocarpine (muscarinic for dry mouth)
Paraplatin=Platinol=Eloxatin: Ethyol
Platinum-based compounds: *Carboplatin**=Cisplatin**=Oxaliplatin*: *Amifostine* (adjunctive to cisplatin for nephrotoxicity)
Sovaldi; Harvoni;Epclusa; Vosevi
Polymerase Inhibitor, multiple HCV genotypes: Sofosbuvir; Sofosbuvir+Ledipasvir; Sofosbuvir+Velpatasvir; Sofosbuvir+Velpatasvir+Voxilaprevir
SymlinPen 60 (DM1) SymlinPen 120 (DM2)
Pramlintide: analog of amylin hormone for postprandial BG control in pts taking insulin 1. MedGuide 2. Refri/RT 30days TIDAC abdomen or thigh 3. BBW: w/ insulin
K-Dur, Klor-Con
Potassium Cl
Klor-con
Potassium Cl
Ezogabine CV
Potiga: anticonvulsant used as an adjunctive treatment for partial epilepsies in treatment-experienced adult patients.
Legitimate DEA
Practitioner: 1st letter is A or B. Mid level practitioner: 1st letter is M. Second letter = usually 1st initial of provider's last name. Step 1: Add 1st, 3rd, & 5th number Step 2: Add 2nd, 4th, & 6th number Step 3: Multiply the sum from step 2 by 2 Step 4: Add the sum of step 1 & 2 (Then, the ones digit of this sum must be the same as the last digit of the DEA number)
Oraprep
Prednisolone
Flo-Pred
Prednisolone Acetate
Millipred
Prednisolone, base(oral tablet, solution, syrup)
Prednisone Intensol, Sterapred
Prednisone
Mandatory Reporting
Prepare/send written report w/in 2 working days OR 36 hours for child abuse or elder abuse
Multiple CII Rx's
Prescriber can write multiple rx's (total 90days supply max per visit) for a single office visit - Do NOT post date - Use date of office visit and state earliest acceptable fill date
imipenem/cilastatin
Primaxin)
medroxyprogesterone
Provera or prometrium
Consumer Medication Information
Provided with each NEW rx - NOT reviewed/approved by FDA - Supplements oral counseling and provide basic info on how to use drug and what to expect
Maintain x at least 2 yrs
Pseudoephedrine, ephedrine, phenylpropanolamine, & norpseudoephedrine sale logs
Adulteration
Quality of drug compromised - Filthy, putrid, decomposed - Unsanitary preparation - Contains recognized drug but strength/purity lowered than official standards - Contains unrecognized drug different from label
Budesonide
Pulmicort Rhinocort Aqua9 nasal
Imuran=Fludara=Purinethol=Lanvis/Tabloid
Purine analog antimetabolites: *Azathioprine**=Fludarabine**=6-Mercaptopurine**=6-Thioguanine*
side effect warning on label
REQUIREMENT: - all rx labels must have "call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088"
INSTI
Ralteravir; Elvitegravir; Dolutegravir
Methylnaltrexone
Relistor
Monitor in Amphoteracin B treatment?
Renal Liver K+
hyponatremia (tolvaptan)
Samsca
Edurant (with food)
Rilpivitine (NNRTI)
Benzos and Z drugs are...
Schedule IV Belviq QSYMIA as well
Sexobarbital capsule
Seconal CII
Partial 222 Order received?
Sender has 60 days to send it in. If they don't they can endorse it to another supplier and forward copy 2 to the DEA.
Interim period for a temporary pharmacist-in-charge
Shall not exceed 120 days
Butorphanol
Stadol C.IV
Fansidar(SE: bone marrow suppression, hemolysis with G6PD deficiency. sulfa allergy)=Malarone*(Antifungal and anti-parasite It can treat and prevent malaria.)*take daily until 1 weekafter travel, no in pregnancy, breastfeeding, severe renal impairment
Sulfadoxine/pyrimethamine=Atovaquone/proguanil
Dronabinol
Syndros, Marinol CIII (CINV)
Pentazocine
Talwin C.IV
Medicaid prescriptions require:
Tamper resistant prescription blanks where: 1 or more features to prevent - unauthorized copying - erasure or modification of information written - use of counterfeit prescription forms
5th gen cephs
Teflaro
Vibativ
Telavancin 1. Gram+, MRSA 2. BBW: preg-C; test prior therapy; MedGuide 3. 3A4/5 inhibitor & QT prolongation effects
Vemlidy
Tenofovir+alafenamide (TAF)
Preemption Doctrine
The concept that federal law takes precedence over state or local law.
Notify the board of d/c of drug take-back services
Within 30 days
Notify the board of establishment of drug take-back services
Within 30 days
What percentage of compounded meds can be shipped out of state
Up to 5% only.
Class II Recall
Use/exposure can cause temp or reversible ADR or where probability of harm is remote - Particles in vials
Diovan HCT
Valsartan/Hydrochlorothiazide
Navelbine=Velban/Velbe=Vincasar/oncovin/Vincrex
Vinca Alkaloids: *Vinorelbine*=*Vinblastine*=*Vincristine*: do not give IT
Refrigerated eyedrops
Viroptic Zioptan Xalatan
Mephyton
Vitamin K or phytonadione***protect from light
Estradiol patch
Vivelle-Dot
Pharmacy Recovery Program
Voluntary basis May be referred to in lieu of or in addition to discipline by board
VFEND (po: 300mg q12h, IV: 4-6 mg/kg)
Voriconazole: 1. DOC for aspergilus =Isavuconazonium(cresemba) 2. cause blurred vision 3. photosensitivity 4. Hepatotoxicity 5. empty stomach 6. DDI: tablet contains lactose, liquid contains sucrose 7. IV sol do not refri and use imediately
Trintellix
Vortioxetine(SSRI, 5-HT Receptor Antagonist, 5-HT1A Agonist)
Lisdexamfetamine (ADHD and binge-eating disorder)
Vyvanse CII
Coumadin; jantoven **avoid pregnancy; DOC with mechanical heart valves;
Warfarin sodium
How often must Schedule II, III and IV prescriptions be filed electronically to CURES?
Weekly (H&SC § 11165[d])
Submit dispensing data to CURES
Weekly, even if number is 0
CA Security Form in Terminally Ill
Write "11159.2 exemption" on plain rx Only for terminally ill: Death expected w/in 1yr
can you change a medication of a tablet to an oral liquid on a prescription where the prescriber did not specify do not substitute?
YES! equivalent active ingredient, strength and duration effect. the change must be communicated to the prescriber and patient
hydrocodone containing products
ZOHYDRO ER, HYSINGLA ER, norco, vicodin, tussicaps, tussionex, vicoprofen, xodol
Schedule II drugs can be transferred...
Zero times.
azithromycin
Zithromax, Z-Pak) 500mg day 1 + 250mg days 2-5 (or 500mg x 3d) with/out food, but ER susp empty stomach
(hydrocodone bitartrate) Extended-Release
Zohydro® ER (hydrocodone bitartrate) Extended-Release
Definition of a "closed" pharmacy
a pharmacy not engaged in teh orginary activity for which a license has been issued for at least *one day each week* during any *120 day period*
amphetamine/dextroamphetamine
adderall, adderall XR c2
alfentanyl
alfenta c2
amobarbital
amytal sodium c2
anabolic steroids such as testerosterone
androgel, androderm, testim, fortesta, depo-testersterone c3
Compounding P&P manual is reviewed by PIC how often?
annually
How often do pharmacy permits need to be renewed?
annually
phentermine
apipex-p or lomaira c4
What is the time limit requirements in the keeping of pharmacy records for *patient medication profile records*?
at least 1 year
Manufacturer, distributor, researcher, lab, and *narcotic treatment group*
begin with P or R
buprenorphine containing product
belbuca, buprenex, butrans, probuphine implant kit, sublocade, suboxone, zubsolv, bunavail, c3
How many refills are valid for a c3-4?
cannot exceed 5 refills, or 120 days of refills
avinza
capsules are a modified-release formulation of morphine sulfate
diethylpropion
dietthylpropion c 4
meperidine
demerol c2
methadone
dolophine, methadose, methadone HCl Intensol,
fentanyl
duragesic, actig, fentora, subsys, lazanda, abstral
Injection Card System
enables a facility to authorize an outpatient to receive injections of controlled substances at that facility - injections are authorized by written order from prescriber and recorded on card
EES, Ery-tab)
erythromycin Pregnancy Cat B: Azithromycin > erythromycin > clarithromycin (Cat. C)
gildess fe, junel fe 1/20, loestrin 24 fe,microgestin fe 1/20, minastrin
ethinyl estradiol/norethindrone/ferrous fumure
How often must a pharmacist license be renewed?
every 2 years
controlled substances inventory
every 2 years
How often must a pharmacist/intern/tech complete an inspection of all floor stock and drugs maintained at a nursing station? When should tech report irregularities?
every 30 days (CCR § 70263[q][10]) to PIC AND Director of Health Care Facility within *24 hours*
How often does the pharmacy generate a controlled substance printout for refills of Schedule III-‐V prescriptions which contains the signature of the dispensing pharmacist?
every 72 hours (21 CFR § 1306.22)
How often must a pharmacy license be renewed?
every year
Schedule III-V can be...
faxed and used as the original as long as the prescriber signs the prescription before faxing it. IIs can be faxed over if the patient is the resident of: Licensed skilled nursing intermediate care home health hospice.
Beyond Use Dating for Sterile compounds prepared outside ISO class 5 PEC
for IMMEDIATE use only - administration shall begin no later than 1 hour following start of the start of the compounding process
Upon closure of a pharmacy, a transfer of drugs notice must be provided to the board within what time period?
in writing, within 10 days of the closure
Soliqua
insulin glargine & lixisenatid
What if a prescription drug does not contain an expiration date?
it is considered EXPIRED and may NOT be dispensed!
Can a pharmacist fill a 90 day supply for an rx written for a chronic condition with a 30 day supply and prn refills?
it must first be filled for the quantity written, but subsequent refills can be dispensed up to a 90 day supply. this does NOT apply to controls or psychotropic prescriptions
What happens to the remainder of the control rx's left over at a SNF or hospice facility if patient dies?
it needs to be destroyed in a relatively short period of time
dronabinol capsules
marinol c3
reglan
metoclopramide
3,4 methylenedioxymethamphetamine or MDMA
no bn but c 1
Sufentanil
no bn c 2
How long can a RPh leave the pharmacy area for?
not more than 30 minutes
Surgical clinics defintion
only engaged in surgical procedures
oxycodone containing products
percocet, percodan, endodan, endocet, oxycontin, roxicodone, oxaydo xartemis xr, xtampza er c 2
may prescription drugs be returned to a pharmacy?
pharmacis have the right to take rx drugs bacck from patients and reimburse them BUT THEY ARE OBLIGATED TO DESTROY THE DRUG once taken back and NOT reuse it for a subsequent prescription
modafinil
provigil c4
benzphetamine
regimex c3
Morphine has a metabolite that is....
renally cleared and contributes to analgesia and sedation.
faxed rx from pt
rx faxed by a pt is NOT a legitimate rx and canNOT be dispensedwithout the original rx
Secobarbital
seconal c 2
Expiration for compounded products
shall NOT exceed 180 days (6 months)
How soon shall c2 losses be reported?
shall be reported to the *Board* within *14 days*
Who creates regulations>
state agencies ex: Board of Pharmacy
Who can pass a statute?
state legislature
How does a pharmacy return its C2's back to the supplier?
supplier furnishes the form 222 - pharmacy retains copy 1 - pharmacy sends copy 2 to the DEA - supplier retains copy 3
dronabinol solution
syndros
(Ketek
telithromycin
tell me all the example of rems drugs
thalidomide, isotrtinoin, clozapine, qsymia((Phentermine and Topiramate Extended-Release), avinza, butrans, dolophine, duragesic, exalgo, hysingla er, kadian, methadose, ms contin, nucynta er, oxycontin, zohydro er, hysingla, and all other er and la opioid analgesics, saxenda, addyi
biennial self assessment >?
the PIC must complete a biennial ( every other year) self-assessment form for thier pharmacy before july 1 of each odd number year ( by july 1 2017 then again by july 1 2019) a new self assement must submit it if the pharmacy a a new pic, or move to a new location, or new permit is issue.
Can a pharmacy accept a faxed control rx?
the rx must be transferred onto a pharmacy prescription blank and taken as a phone rx and verified by prescribers office
What is the max quantity or day supply that can be dispensed at one time for a c2?
there is NO limit of quantity of day supply set by law rule that rx for controls shall NOT exceed a 6 month period BUT RPh must fully document in writing the justification for dispensing large amounts of C2s
Within how many days must the BOP be notified in the case of bankruptcy, insolvency, or receivership?
to be reported immediately in writing
"furnish"
to provide (sell, use rx insurance) without rx from MD
DEA 224
to register with DEA. Renewed Q3 years within 60 days of expiration date.
DEA 106
to report any loss/theft of CS. Must be reported within 1 business day.
when can you omit conviction of violating any law in any state?
traffic infractions under $500 that do not involve alcohol, dangerous drugs, o controlled substances
codeine/acetaminophen
tylenol with codeine number 3 tylenol with codeine number 4 c3
tramadol containing products
ultram, ultracet, conzip c4
Time period to electronically send in info on schedule 2 - 4 rx per CURES program
under CURES program must be sent weekly
How long is a temporary permit issued upon transfer of ownership good for?
up to 180 days
Temporary permit issued upon transfer of ownership
up to 180 days
How many interns can a pharmacist supervise at a given time?
up to 2
How many refills can a c3-5 have?
up to 5 refills within 6 months. refills not to exceed 120 days total
How long are California's intern license valid for if they are currently enrolled in an accredited school?
up to 6 years
Within how many days must the DEA be notified of controlled substance loss (or theft)?
upon discovery (21 CFR § 1301.74[c])
low csp risk level
use only sterile ingredients use only sterile equipment no more than 3 ingredients no more than 2 entries into any 1 sterile container or device use only closed or sealed systems limited to transferring, measuring, and mixing manipulations exmaple: reconstituting a single dose vial of antibiotic with sterile water and transferring it to a normal saline IV bag
Time period a schedule 3,4,5 rx must be filled or refilled before it is void
usually within 6 months from date written refills not to exceed 120 days
eluxadoline Eluxadoline is a new therapeutic agent that reduced symptoms of IBS with diarrhea in men and women, with sustained efficacy over 6 months in patients who received the 100-mg dose twice daily.
viberzi c 4
lacosamide a prescription medicine that has been approved to treat partial-onset seizures in people 4 years of age and older.
vimpat c 5
lisdexamfetamine
vyvanse c 2
*colesevelam*(less GI SEs, adjunct therapy for DM)*=colestipol=cholestyramine*: 1. bile-acid binding resins 2. ok for hepatic disease 3. SE: constipation, gas, bloating>>^water and fiber 4. mix powders with food or liquids. Administer other drugs 2 hrs before or 4 hrs after.
welchol=colestid=Questran, Prevalite
Criminal action
when a law is broken parties involved: federal, state, county or city compensation: fine, prison
can a pharmacy advertise or promote the compounding of a specific drug, drug class, or drug type?
yes
Can use buprenorphine and methadone with Benzos?
yes - but caution for CNS depression
Do out-of-state manufacturers, wholesalers, or pharmacist require permit to operate in state?
yes! must obtain an "out-of-state drug distribution license" or "nonresident pharmacy registration" renewed anually and not transferable
drug is not readily available pursuant a emergency rx can they borrow from a nonprofit pharmacy?
yes! they may borrow the drug from a nonprofit pharmacy, and dispense it to a patient at the for-profit price. borrowed drug must be returned to the non-profit exactly as it was attained originally )same drug, strength, amount, and manufacturer). *for-profit may NOT purchase drug from non-profit*
Can Dimethyl Sulfoxide (DMSO) be prescribed?
yes, although not FDA approved. prescriber responsible for : - signed informed consent of risk vs. benefit - pharmacies who dispenses drug not required to have the patient sign an informed consent - DMSO ordered from chemical supply dealer
Can a prescriber legally write a oxycontin prescription for a 120 day supply?
yes, as long as it is on 1 prescription and does NOT employ the serial c2 process which limits it to 90 days
Can advanced practice pharmacist adjust or initiate control substance therapy?
yes, but must first register with DEA
are pharmacists allowed to make substitutions involving biological drugs?
yes, if the alternative biological product is interchangeable and the prescriber provides no objection the change must be communicated to the prescriber and patient
If the RPh feels it's best to omit info, can they?
yes, if they log it in pt record or a log for that purpose.
1. Chlor-Trimeton=Tavist=Benadryl=Phenergan=Unisom 2. Zyrtec=Xyzal=Allegra=Claritin=Clarinex; Astelin/Astepro=Patanase 3. Sudafed=Sudafed PE, Privine=Neo-Synephrine 4 hr=Afrin/Neo-synephrine 12h=Otrivin 4. Nasalcrom, Atrovent, Singulair
Allergies and Cough: 1. 1st generation: *Chlorpheniramine* (OTC)*=Clemastine*(OTC, avoid in preg) *=Diphenhydramine*(OTC, 25-50mg hs or q4-6h PRN, max 300mg)*=Promethazine*(Rx, not for <2yo: fatal respir, depression)*=Doxylamine*(OTC, 50mg q4-6h, insomnia 25mghs): SE: sedation+anticholinergic+inhibit CYP450>>avoid if BPH, glaucoma, hyperthyroidism, CV 2. 2nd generation: *Cetirizine*(OTC, Rx, onset 1h, most sedative)*=Levocetirizine*(onset 1h)*=Fexofenadine* (OTC, least sedative)*=Loratadine*(OTC, least sedative) *=Desloratadine*(Rx) Intranasal: *Azelastine=Olopatadine*(2 sprays each nostril BID) 3. Decongestants: a-adrenergic agonists *Pseudoephedrine*=*Phenylephrine* *Naphazoline=Phenylephrine=Oxymetazoline=Xylometazoline*(use <3d): SE nervousness, dizziness, HA, seizures, insomnia. CL if taking MAOIs. preg-C, use antihistamines for HTN/CVD pts 4. Additional agents: *intranasal cromolyn* *Intranasal ipratropium bromide* *Montelukast*
Exforge Hypertension Calcium channel blocker + ARB
Amlodipine and Valsartan
Lotrel; Azor
Amlodipine/Benazepril; amlodipine/olmesartan
Norvasc=Plendil=DynaCirc=Cardene=Adalat CC, Procardia XL=Sular
Amlodipine=Felodipine ER=Isradipine CR=Nicardipine=Nifedipine ER=Nisoldipine: 1. more potent vasodilators>>reflex Tachycardia>>ok with BB but CI if acute MI, CI CHF 2. Ineffective for arrhythmias 3. SE. HA, flushing, edema of the ankle 4. No significant DDI
Secobarbital suppository schedule
Amobarbital, secobarbital, & pentobarbital suppositories = CIII. Tablet, oral liquid, cap, injectables of these agents = CII
Augmentin
Amoxicillin/Clavulanate Potassium: acute otitis media, H.Pylori, pregnancy, endocarditis PPX, refrigerate, okay for 14d at RT, w/f q8-12h
Amoxil, Moxatag
Amoxicillin: refrigerate susp. okay 14days @ RT; w/food q8-12h
Dextrose
Amphotericin B Synercid Bactrim
Saline
Ampicillin Unasyn Dilantin Invanz Cancidas (capsofungin) Cubicin Remicade (infliximab) (AUDI CCR)
Principen>>Unasyn
Ampicillin: **Birth control less effective**non-PVC>>+sulbactam
Compounding policy and procedures should be reviewed how often?
Annually
Disclosure to board of service and location of each take-back receptacle
Annually, at item of facility license renewal
Disclosure of service and location of each receptacle
Annually, at time of facility license renewal
Cerubidine=Adriamycin/Doxil/Rubex/Caelyx/Myocet=Ellence=Idamycin=Novantrone; Zinecard and Totect
Anthracyclines: *Daunorubicin*=*Doxorubicin*=*Epirubicin*=*Idarubicin*=*Mitoxantrone*It can treat multiple sclerosis (MS). It can also treat prostate cancer and certain types of leukemia, such as acute nonlymphocytic leukemia (ANLL): 1 All cause red urine except Novantrone>blue 2. *Dexrazoxane* prevents heart damage and treats extravasation
1. Arimidex=Aromasin=Femara=Faslodex 2. Evista=Fareston=Nolvadex 3. Megace
Antiestrogens for Breast Cancer: 1. Oral AromataseI(after menopause) *Anastrozole=Exemestane=Letrozole*(w/f)*=Fulvestrant*(IM) 2. Oral estrogen blockers: *Raloxifene*(DOC osteoporosis in F w/breast cancer risk)*=Toremifene=Tamoxifen* 3. *Megestrol* treat breast and uterine cancer. Liquid to ^appetite and prevent wt loss in pts with AIDS
Keep drug acquisition records, disposition records
At least 3 years
How long should <b>clinic</b> pharmacy prescription records be kept
At least 3 years after last filling of prescription
How long should <b>community</b> pharmacy prescription records be kept?
At least 3 years after last filling of prescription
How long should <b>hospital</b> pharmacy prescription records be kept?
At least <u>7 years</u> after last filling of prescription
If unable to supply the full quantity, a pharmacist may partially fills a Schedule II prescription and the remaining portion of the prescription must be filled within what time frame?
"72 hours(21 CFR § 1306.13[a])"
When must the pharmacy conduct a Self-‐Assessment? (CCR § 1715)
"Before July 1st every odd-‐number year or within 30 days of (1) a new permit;(2) change in PIC; (3) change in location"
CA BOP Vision Statement
"Healthy Californians through quality pharmacist's care."
What is the max amount that may be charged for administrative fees for emergency contraceptive agent?
$10, no charge if OTC
If pharmacist is involved in a lawsuit, beginning at what settlement dollar amount must it be reported to BOP
$3,000
What is the fee for CURES?
$6 annual fee
All licensed pharmacists can:
*-Administer drugs and biologics as prescribed* - provide drug + disease information - Participate in reviews of patient progress. *-Self-administered hormonal contraceptives -Travel meds* -Nicotine Replacement Products - *Vaccinate over 3 y/o* -Order and interpret tests. Including the community setting.
1. MedGuide 2. T1/2=55 days 3. non-PVC/glass for infusion>2hrs 4. D5W only 5. monitor thyroid, liver and lungs 6. SE: vision change/corneal microdeposits, photosensitivity, slate blue skin, hypotension, bradycardia, dizziness and tremor 7. Use lower dose of digoxin, warfarin, quinidine, procainamide, statins 8. caution w concurrent use of BB, verapamil, diltiazem d/t bradycardia 9. take with food (N/V) and water(constipation)
*Amiodarone(Cordarone)*IV, oral: broad-spectrum antiarrhythmic, safe in HF and post MI, only for life-threatening arrhythmias because of risk of hepatol/pulmonary toxicity
Cordarone, Pacerone, nexterone(MedGuide)=Tikosyn(MedGuide)=Multaq(MedGuide)=Corvert=Betapace
*Amiodarone=Dofetilide=Dronedarone=Ibutilide=Sotalol*
Amphocin(life threatening fungal infection); fungizone; abelcet(lipid complex); AmBisome(liposomal)
*Amphoterin B infusion ;injection*: 1. preg-B 2. decrease K(enhance digoxin toxicity) and Mg (good for heart) 3. Nephrotoxicity (not comb with cyclosporine, AMGs, flucytosine, cisplatin) 4. D5W only: 50mg in 10ml >withdraw dose and dilute to 500ml or 250ml> use pre-med
strattera; wellbutrin; intuniv, kapvay
*Atomoxetine*: SNRI for ADHA 1. MedGuide, BBW: ^ risk suicide in children 2. CL if MAOIs, glaucoma, pheochromocytoma 3. SE: GI, sedation, decreased appetite, dose by wt Qday and comb w/stimulant, less HA 4. delayed onset(2-4 wks) and less efficacy; adjunctive tx: 1. *bupropion*, 2. a2 adrenergic agonists: *Guanfacine ER*, *Clonidine ER*
Wellbutrin SR, Wellbutrin XL, Zyban 150 (smoking secesaion); +naltrexone=contrave(wt loss)
*Bupropion Hcl*1. MedGuide, start 1-2wks before 2. BBW: suicidal thoughts>not for children/bipolar 3. SE: wt loss, dry mouth, insomian, seizure(>45mg/day) 4. CI: seizure, eating disorder, MAOIs(2 wks washout required) 5. preg-c, but still use; *Vareniciline*: 1. more effective but not w/NRT 2. MedGuide, start 1 wk before 3. w/f and full glass of water, 2nd pill with dinner to decrease insomnia 4. BBW: Psychiatric events, SE: N/V, sedation, constipation, vivid dream 5. Preg-c
stool softener + stimulant laxative
*Combo therapy is recommended for severe/resistant constipation. I.e. cancer pts: stool softener + stimulant laxative
*Boostrix*(>=10yo, IM); *Adacel*(11-64yo, IM)
*DTaP, DT,Tdap,Td*(Diphtheria, tetanus, pertussis, Whooping cough): Tdap once and then Td booster q10yr; 1xTdap with each preg
1. Selsun Blue 2. Nizoral A-D; Lamisil=Micatin=Tinactin=Lotrimin=Nizoral=Penlac; lamisil=Sporanox=Diflucan; Protopic=Elidel
*Dandruff*: OTC: 1. *Selenium sulfide* *=Pyrithione Zinc=Salicyclic=Sulfur=coal tar shampoos* 2. *Ketoconazole*: BBW: hepatoxicity; apply 2xwk for 2mo, need acidic pH for absorption:avoid using antacids, H2RAs, PPIs, ^hair lossand altered hair texture *Fungal infection& Athlete's Foot*: 1. OTC: *Terbinafine 1%*(Most effectiveness, less CYP450) *=Miconazole 1%=Tolnaftate 1%=Clotrimazole 1%*(OTC or Rx); *Ketoconazole cream*(Rx^CYP450 MedGuide) *Ciclopirox* (for athlete's foot. Also used as lacquer that apply directly to the affected nails) Onychomycosis/Nail fungus: *Terbinafine=Itraconazole*( 1. take with food for cap, 2. BBW-HF 3. avoid antacids, H2RAs, PPIs): (250mg PO fingernail 6wks tornails 12wks, monitor for hepatotoxicity)*=Fluconazole* (150mg 1wk 6-9mo, no monitoring) *Eczema*: 1st topical steroids>*Tacrolimus&Pimecrolimus* (for severe atopic dermatitis and off label for resistant psoriasis-MedGuide, no for <2yo)1
Epipen, EpiPen Jr, Adrenaclick
*Epinephrine(injection)* incompatible with bicarnonate *Norepinephrine*(mix with D5W)
Drisdol, VitD2=Rocaltrol, VitD3
*Ergocalciferol VitD2(inactive)=Calcitriol(active)*: Monitor for hypercalcemia and hyperphosphatemia, parathyroid hormone q3-4 months
Tablet: Estrace, Premarin, Cenestin=Patch: Alora, Climara, Estraderm/Vivelle Dot=Vaginal ring: Estring, Femring=Topical: Estrasorb; Tab: Activella, Femhrt, Estratest, and Premphase or Prempro=Patch: Climara, CombiPatch; Tab: Provera=IM/SC: Depo-Provera; Ortho Micronor, Camila, Errin, Jencycla, Nor-QD
*Estrogen alone* 1. For no uterus d/t ^endometrial cancer risk 2. CI or lone-term risks(>4yrs): breast cancer, CVT/PE/stroke/MI, liver dysfunction, pregnancy;*Estrogens+Progestins* 1. For women with uterus 2. progestin decreases risk of endometrial hyperplasia *Progestin alone* *Medroxyprogesterone* 1. preg-X, 2. For HRT/amenorrhea/endometriosis: 5-10mg tab QD or 50mg IM qwk or 100mg IM q2wks; BBW: breast cancer, CV disease, bone mineral density loss; For contraception, no menstrual flow and pelvic pain, but irregular bleeding for first 3 mos *POP or minipill: Norethindrone*(preferred for women who are breastfeeding because estrogen decrease milk production. All come in 28-d packs and all pills are active. Period comes by the end of the pack, if not disappear); *Mirena IUD* 1. delivers small amounts of levonorgestrel up to 5 years SE: bleeding/spotting for 3-6 mo. Increase risk of infection, PID, ectopic pregnancy
Duragesic(flush), Actiq(po lozenge), lonsyn(transderm system), sublimaze; subsys(subline spray); Lazanda(nasal spray); abstral=Fentora=Onsolis(SL tablet)
*Fentanyl*: C-II 1. most potent for chronic pain only 2. patch q3d 3. transmucosal (buccal film/tablet, SL, lozenge)form and nasal spray>most potent for cancer pain>REMS drug 4. Transmucosal, TD patch/nasal forms are CL in acute or postop pain and opioid naive pts.
Cytovene/Cymevene/Vitrasert=Valcyte=Vistide=Foscavir
*Ganciclovir=Valganciclovir=Cidofovir=Foscarnet*(only for immunocompromised pts with CMV retinitis and mucocutaneous acyclovir-resistant HSV; renal impairment; seizures): Cytomegalovirus; renal toxicity
ActHIB, Hiberix, PedvaxHIB IM
*Haemophilus influenzae type b*: inactivated, given to children. sometimes in adults if HIV+, splenectomy, sickle cell disease, leukemia, or not previously vaccinated
Havrix(has preservative)=Vaqta(preservative free); Engerix-B= recombivax-HB; Twinrix
*Hepatitis A vaccine*>*B*>*A-B*: inactivated, IM, given to children, homosexuals, IV drug abusers, chronic disease, travelers, health care workers(HepB)
Cervarix&Gardasil
*Human Pappillomavirus*: inactive, IM, 11-12 yo, up to 21(males) and 26(females)
Apresoline=Loniten/Rogaine 2-5%
*Hydralazine*(SE: lupus like symptoms)=*Minoxidil* (hair growth, OTC for men and women): direct vasodilators>>caution: reflex tachycardia
Boniva=Reclast=Actonel, Atelvia=Fosamax; Evista; Forteo; Prolia, Xgeva
*Ibandronate*Oral and IV q3mo=*Zoledronic*5mg/100ml once/year IV; No GI problem; Flu-like s/sx(treat with APAP)=*Risendronate*take atelvia after bf and don't lie down=*Alendronate*: 1. 1st line, ok for men, MedGuide 2. SE: bone pain, heartburn, jaw necrosis, esophageal cancer, atypical fracture 3. CL: hypocalcemia, renal ds., pregnancy; *Raloxifene* 1. 60 mg Qday, 2. preferred if breast cancer, 3. CL in pregnancy 4. BBW: ^CV disease and thromboembolic risk, MedGuide 5. SE: hot flash, flu-like sym, good lipid effects *Estrogen* PPX ok for menopause *Phytoestrogen: isoflavones* found in soy, black cohosh, dong quai and red clover. have estrogen activity *Teriparatide Inj* 1. parathyroid hormone, approved for men 2. MedGuide 3. injec thigh or abd 20mcg SC Qd, max 2 yrs 4. refri all the time and discard after 28ds 5. BBW: osteosarcoma, bone metastases. very potent and voluntary Forteo pt registry *Denosumab inj* 1. Monoclonal antibody, MedGuide 2. CI if hypocalcemia , caution: infection, osteonecrosis of the jaw. no renal concern *Calcitonin: Miacalcin inj* inj 100 u SC/IM Qd or nasal spray *Fortical Nasal* refri, RT 30 ds-prime before 1st use. 200u/1 spray, pump, do not inhale
*FluMist*(Intranasal spray, 2-49yr, live attenuated>avoid preg and children)*Fluzone*(>=6mo/6mo; >=36mo)*=Fluarix=FluLaval*(>=3yo)*=Fluvirin*(>=4yo, careful latex)*Afluria*(needle:>=9yo; jet injection:18-64yo)*Flucelvax*(>=18yo careful latex)*FluBlok*(recombinant, >=18yo)*Fluzone*(intradermal, 18-64yo) *Fluzone HD*(>=65yo)*Fluad*(>=65yo)
*Influenza*
1. BBW: fatal hepatitis develop within 3 mos 2. Neurotoxic: add Vit B6(pyridoxine) 3. Lupus/flu-like symptoms 4. P-450 inhibitor 5. empty stomach
*Isoniazid (INH)*: alone to prevent latent TB from becoming active; 300mg QD for 9 ms
Isuprel
*Isoproterenol*: HTN, incompatible with bicarbonate
Xylocaine(drugs increase level: amiodarone, BB and 3A4 inhibitors)=Mexitil
*Lidocaine(IV)=Mexiletine (oral)*: class Ib
Zyvox: do not shake suspension
*Linezolid*: 1. Gram+, MRSA, VRE 2. mix with D5W, no refri 3. SE: myelosuppression 4. MAOI: avoid 1)tyramine(wine, alcohol and fermented foods) 2). serotonergic drugs(TCAs, MAOIs, SSRIs) 3). adrenergic drugs-HTN crisis
*Latuda*
*Lurasidone* (schizophrenia) :1. No prolactin elevation, No wt gain, least sedating, least orthostasis 2. bipolar depre: monotherapy or adjunt to lithium or valproate 3. Give w/f 4. DDI: CYP3A4
Tapazole; PTU; SSKI=Lugol's solution
*Mathimazole* 10 PTU potency, DOC since QD dosing, 2nf and 3rd trimesters *Propylthiouracil* MedGuide BBW: acute liver failure, 1st trimester 1. Monitor CBC for agranulocytosis, 2. w/f to reduce GI upset *Iodide* DOC for tx of thyroid storm prior to thyroidectomy*BB: propranolol* s/sx
Nitrostat=Tridil(non-PVC, D5W, no refrig)=Nitro-Bid=Nitro-Dur, Minitran=NitroMist, Nitrolingual(do not shake container, prime 5-10 times, close mouth after use)=Nitro-Time=(IR-BID)Isomo, Monoket(ER-QD)Imdur=(IR)Isordil,(SR)Dilatrate-SR: w/ hydralazine for HF
*Nitroglycerin SL tablet=IV=ointment 2%=patch=spray, translingual=ER tablets=Isosorbide Mononitrate=Isosorbide Dinitrate*
PPSV23(IM/SC), PCV13(IM)
*Pneumococcal* inactive,
Mirapex=Requip=Apokyn=Cycloset
*Pramipexole*(decrease levodopa dose by 50%)*=Ropinirole*(start 0.25mg. Max 24mg/d)*=Apomorphine*(SC for "rescue" "off" period cause N/V take with Trimethobenzamide/Tigan)*=Bromocriptine*(rarely use d/t SE; adjuct therapy diabetes>0.8mg, w/f, first thing QAM, max 4.8mg daily, decrease insulin resistance. CL if allergy to ergot drugs): Dopamine Agonists: 1. Monotherapy, 2. needs titration and tapering 3. SE: nausea, drowsiness (sudden daytime sleep attacks), orthostasis, hallucinations
What drugs are used for the treatment of narcotic addiction?
- *methadone* - opium - morphine - hydromorphone (dilaudid) - meperidine (Demerol)
Plan B 1 step for OTC sale
- 1 tab levonorgestril 1.5 mg - may be sold in stores - taken within 72 hours - may purchase more than 1 pack - no admin fee - no consultation required - no age requirement
Aid in Dying Pt Requirements
- 18+YO - CA resident - Mentally competent - Terminally ill (w/in 6mo confirmed by 2 MDs)
Rx Refills (CV)
- 6mo expiration from date on rx *No max refills or days supply limit
Death with dignity
- 9 grams secobarbital - 18 years or older - incurable and irreversible disease - death within 6 months - 2 oral requests, 15 days apart with 2 witnesses - prepared by MD or RPh and taken to the home of the pt
Schedule III Drugs
- Anabolic steroids - Buprenorphine containing products - Butabarbital - Butalbital containing products - Codeine/APAP - Dronabinol - Ketamine - Sodium oxybate
Schedule IV Drugs
- Armodafinil - Benzos - Carisoprodol - Diethylpropion - Lunestsa - Belviq - Phenobarbital - Phentermine - Belsomra - Tramadol - Sonata - Ambien
transferring non-controlled rx
- BEST TO TRANSFER BY PHONE - can be transferred as many times as there are refills
CLIA Waived Tests
- Blood glucose - A1C - Cholesterol
Schedule V Drugs
- Brivaracetam - Vimpat - Lyrica - Lomotil - Codeine cough syrups
Is the loss significant?
- Can drugs be subject to diversion - Specific substances lost or stolen - Qty lost in relation to type of business - Individuals w/ access to lost or stolen drug - History or pattern or losses or local diversion issues
Schedule II Drugs
- Cocaine - Codeine - Adderall - Vyvanse - Pentobarbital - Methadone - Paragoric (Schedule III at federal level)
Do NOT Substitute
- DAW1 - Between long acting and short acting - Combo products for single ingredient products
Requirements for disposal of controls
- DEA Form 41 - all controls to be disposed must be listen, 3 copies of the form must be completed and sent to the regional DEA director
Unit Dose Label Requirements
- Date med was prepared - Beyond use date (no later than 1yr from date drug was repackaged or exp date on manufacturer's container) - Drug name - Qty of active ingredient - Special storage/handling requirements - Lot/control number assigned by centralized hospital packaging pharmacy - Name of centralized hospital packaging pharmacy
Patient Counseling Requirements
- Directions for use - Importance of compliance with directions - Precautions and relevant warnings - Storage
Class of Drugs that Need Auxiliary Label if they pose risk to pt when taken in combo with alcohol
- Disulfiram - MAOI - Nitrates - Cycloserine - AntiDM agents - Per RPh's judgment, any other drugs which may pose substantial risk to person consuming drug when taken in combo w/ alcohol
Recall Notices
- Drug dispensed directly to pt, notice given to pt - Drug dispensed to MD, notice made to prescribe who may or may not tell pt - Drug dispensed to pharmacy, notice made to pharmacy, pharmacy notifies MD or pt, if pharmacy notifies MD, then MD must notify pt
Rx Label Requirements
- Drug name - Directions for use - Patient name - Date of issue - Pharmacy name/address - Rx number - Drug strength - Drug qty - Expiration date - Condition of purpose of drug (if written on rx) - Physical description of drug (color, shape, imprint) *If brand is dispensed - List brand name - Manufacturer not required *If generic is dispensed - List generic name - Label "generic for ___" - List manufacturer
Outsourcing Facility Requirements
- Drugs compounded with CGMP - Licensed by FDA and BOP as outsourcing facility - NOT licensed as sterile compounding pharmacy at the same time - Can NOT perform functions of a pharmacy - Inspected by FDA an BOP - Preparations made by or under RPh supervision - Meet certain labeling requirements, drug reporting requirements, ADR reporting requirements
Delivering Drugs to Community/Outpt Pharmacy
- Drugs placed in secure storage facility in same building as pharmacy - PIC/RPh designated by PIC has access to secure storage facility after drugs/devices delivered - Secure storage facility has means of indicating whether it's been entered after delivery - Pharmacy maintains P&P for delivery - Person delivering leaves documents indicating name and amount of drug/devices delivered - Keep records related to deliveries
Pharmacists in California can furnish.....(Non-APP)
- Emergency Contraceptive - Self-administered hormonal contraceptive - routine immunizations recommended by the CDC > 3 years - Naloxone - Nicotine replacement products With dependent authority can prescribe II-IV with the addition of DEA
Red Flags
- Irregularities on rx - Nervous pt - Age or presentation of pt - Multiple pts with same address - Multiple prescribers for same pt for dup therapy - Cash payments - Frequent early refill requests - Suspicious rx's brought in at busiest time and pt decides to wait - Rx's written for unusually large qty of drugs - Rx's written for dup drug therapy - Initial rx's written fr strong opiates - Long distances traveled from pt's home to prescriber's office or to the pharmacy - Irregularities in prescriber qualifications - Rx's written outside of scope - Rx's with no logical connection to illness/condition - Pts coming in groups - Same diagnosis code for many pts - Same combo drugs for multiple pts
Class of Drugs that Need Auxiliary Label if they may impair a person's ability to operate a vehicle or vessel
- Muscle relaxants - Antipsychotics w/ CNS depressant effects - Antidepressants w/ CNS depressant effects - Antihistamines, Motion sickness agents, Antipruritics, Antinauseants, Anticonvulsants, AntiHTN agents w/ CNS depressant effects - CS w/ CNS depressant effects - Anticholinergic agents that may impair vision - Per RPh's judgment, any other drugs which may impair pt's ability to operate vehicle or vessel
Repackaging Pharmacies (bubble pack)
- Must have P&Ps for repackaging process - Relabel repackaged drugs with all info required for rx label - Include name/address of pharmacy that initially dispensed the drugs to the patient and name/address of pharmacy that repackaged drugs if different
Refill Pharmacies
- Must have same owner OR a contract outlining refill arrangement - Originating and refill pharmacy address must be included on label - Originating pharmacy responsible for: counseling, maintaining med profiles, performing DURs before each delivery - Can include patient specific parenteral therapy
What should you dispense an epi pen with?
- Name of person on rx - Designation "Section 1797.197a responder" and "First Aid Purposes Only" - Dosage, use, exp date
Immunization Requirements
- Need CDC/ACIP approved immunization training program - Need BLS - Complete 1hr of CE every 2yrs *Must notify PCP or prenatal care provider w/in 14 days **Report to CAIR (pharmacies, not pharmacists, must be enrolled in CAIR) ***Pt vax admin record must be kept and readily retrievable
Patient Counseling
- New rx - Refill rx but in different form, strength, or with new written rx - Pt request - RPh judgment. *no counseling read for pts in health care facilities, adult care facility, juvenile detention facility - should counsel patient's agent for best practice; except when patient is discharged from any of these facilities*
PRN Refills
- Only for non-CS - Max 1 year (standard of practice?)
Employee theft or impairment
- PIC must report to the Board within *14 days* of knowledge of any *licensed employee*: - admits impairment affecting ability to practice - admits to theft, diversion, self use of dangerous drug - video or documentary evidence of ability to practice or theft, use, etc. NOTE: clerks do NOT need to be reported to Board because they are not licensed employee
POA for hospitals
- POA status granted by DEA usually CEO or corporate officer of the hospital - POA may assign POA to another person (such as a RPh, tech, or clerk) to act on their behalf once 1 pharmacy personnel is assigned POA relinquishes responsibility, POA reverts back to original signer of the DEA
Loss or Theft of CS
- Pharmacies report significant loss and all thefts of CS to local DEA in writing w/in 1 business day and complete DEA 106 when circumstances of theft or significant loss are known - RPh reports ALL CS loss to BOP w/in 14 calendar days for losses due to employee theft or 30 calendar days for other types of losses. Can be done in any format, DEA 106 okay too
who may possess key to pharmacy?
- Pharmacist - if pharmacy closed, but rest of business is open to public, store manager can have access to locked unit containing *sealed* key - pharmacy owner in a tamper-free container for the purpose of delivering key to RPh or providing access in case of an emergency
Transaction Information
- Proprietary or established name or names of product - Strength/dosage form - NDC - Container size - Number of containers - Lot number - Date of transaction - Date of shipment, if more than 24hrs from date of transaction - Business name/address of person from whom ownership is being transferred - Business name/address of person to whom ownership is being transferred
Personal Health Information (PHI)
- Pt's past, present, future physical or mental health or condition - Healthcare provided to the pt - Past, present, or future payment for providing healthcare to the patient, which can identify pt
Who is allowed to provide treatment for narcotic addiction with methadone, opium, etc.
- RN - PA - licensed RPh (oral administration only) - psychiatric technician (oral administration only) - licensed vocational nurse (oral only)
Naloxone Requirements to Furnish
- RPh completes 1hr CE - Ask pt if they use opioids or knows someone who does - Ask pt if they have h/o naloxone hypersensitivity - Provide pt training in overdose prevention, recognition, response, and administration - Pt counseling can NOT be waived - Provide fact sheet and notify PCP naloxone was furnished (if given pt's permission) - Keep records for 3 years *Can furnish to school district, county office of education, or charter school pursuant to MD rx
Self Administered Hormonal Contraceptives Requirements to Furnish
- RPh completes 1hr CE, application of US Med Eligibility Criteria for contraceptive use, other CDC guidance on contraception - Pt fills out screening form (initially, annually, major health change) - RPh reviews screening form and clarifies responses - Measure pt's BP if combined estrogen/progestin contraceptives are rec'ed or requested - Counsel pt on dose, effectiveness, ADRs, safety concerns, importance of receiving preventative health screenings, lack of STI protection - Document in pt's profile - Provide pt with: birth control guide from FDA, PPI, administration fact sheet for specific info - Refer to PCP for follow up - Notify PCP if any drugs/divces furnished - Keep records for 3 years
NRT Requirements to Furnish
- RPh completes 2hr CE every 2yrs - Review pt's tobacco use and quit attempts - Asks pt screening questions - If pregnant, do not furnish - If heart attack, caution - If heart palpitations, irregular heartbeats, arrhythmias, caution - If chest pain, unstable angina, caution - If h/o allergic rhinitis, no nasal spray - If TMJ dysfunction, no nicotine gum - Counsel pt on therapy and for further smoking cessation support - Notify pt's PCP - Keep records for 3 years
Common Meds in Aid in Dying
- Secobarbital - Pentobarbital *Anti-emetic an hour before taking is ok to keep drugs down
Drug Storage for Expired Drugs
- Separate from other drug stock
Drug Storage for Drug Samples
- Separate from other drug stock, not allowed in retail pharmacies
Mobile Pharmacy Requirements
- Shared common ownership with at least 1 currently licensed RPh in good standing - Retain records of dispensing - Licensed RPh onsite managing - Reasonable security to safeguard drugs - Located w/in declared emergency area or affected areas - Stop w/in 48hrs after emergency is over
Opiod Overdose Symptoms
- Somnolence (cannot wake up verbally or with sternal rub) - No/slow/shallow breathing, - Miosis (pinpoint pupils) - Bradycardia
QA Program
- Start investigation w/in 2 business days - Keep records for 1yr *Inform the pt and prescriber
Pharmacy Facility Requirements
- Unobstructed safe area for safe practice of pharmacy - Sink with hot and cold running water - Readily accessible restroom - Suitable area for confidential patient consultation - Safeguards to prevent theft of drugs and devices - Pharmacy premises, fixtures, and equipments are maintained in a clean and orderly condition, properly lighted and free from rodents and insects
Pharmacy Facility Requirements for Compounding Sterile Drugs
- Unobstructed safe area for safe practice of pharmacy - Sink with hot and cold running water - Readily accessible restroom - Suitable area for confidential patient consultation - Safeguards to prevent theft of drugs and devices - Pharmacy premises, fixtures, and equipments are maintained in a clean and orderly condition, properly lighted and free from rodents and insects AND - Maintains written documentation regarding facilities and equipment necessary for safe and accurate compounding, including records of cert of facilities or equipment if applicable - All equipment used to compound drug products is stored, used, and maintained in accordance with manufacturers' specifications - All equipment used to compound drug products calibrated before use to ensure accuracy - Document calibrations in writing and keep in pharmacy
Repackaging Meds
- Use CGMP - Label with: drug name, strength, dosage form, manufacturer's name, manu lot number, exp date, qty per repackaged unit - Keep log
additional labeling for Dimethyl Sulfoxide (DMSO)
- Warning: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you" - appropriate precautionary measures for proper handling - first aid treatment and warning statement to keep product out of the reach of children
Can an emergency supply be given for c3-5?
- YES, if prescriber is unavailable, rph must use professional judgement and MAY dispense if there is an *immediate hazard to the patient's health and welfare or might result in intense suffering* - may only be refilled for reasonable amount sufficient to maintain pt until prescriber can be contacted
When can ephedra be dispensed?
- acupuncturists, naturopathic practitioners, herbalists are still allowed to dispense teas, pills, and powders containing ephedra for the purpose of treating colds, asthma, persistent cough, HA, water retention, and other maladies
How to know if a DEA number is correct
- add up all the odd sequenced numbers (except for last digit) - add up all even sequenced numbers and multiple by 2 - add the sum of steps 1 and 2 - the last digit in the sum should be the same as the last digit in the DEA number
Emergency Supply of drugs without refills
- allows pharmacist discretion for refilling both nonscheduled and schedule 3-5. - must be dispensed in a new container properly labeled - pt takes rx regularly - inform pt no refills - rph shall make reasonable effort to contact prescriber - record on back of rx date and amnt of drugs
What must be done when furnishing hormonal contraception
- annual self screening tool - blood pressure - train pt in administration - include handout for product - store record for *3 years* - refer to PCP for follow-up - notify pcp
Who may enter pharmacy area?
- any person with invitation from Pharmacist on duty (POD) - personnel - non-employees with POD invitation including: drug sales reps, prescribers, board inspectors, law enforcement agents, and janitors if non-employees in area, POD must be present in that area
Procedure for contesting a citation:
- appeal to the Board in writing within 30 days or - submit in writing, within 14 days a request for an office conference
pharmacy building standards
- area suitable for confidential pt counseling - properly maintained - sufficient and unobstructed area for safe practice - clean and orderly proper ventilation and lighting - sink with HOT and COLD running water - control against theft or diversion - key for dangerous drugs and controls to be stored restricted to RPh - readily accessible restroom containing toilet, washbasin with running water
Multiple Drug medication package
- auxiliary label: "store in cool, dry place" - contains no more than 1 month supply
What to do if a patient brings in a c2 for a 60 day supply and insurance will only pay for a 30 day supply?
- bill the insurance for a 30 day supply and patient may pay cash for the remaining prescription
Can a clinic licensed to dispense rx, dispense c3-5 rx's?
- c3-5 can be stored and dispensed at multispecialty cliinics
How do c5's differ from c3-4?
- c5 usually intended for cough or diarrhea (exception Lyrica) - law allows for 1 rx for a c5 to be written for more than 1 person in the same family for the same medical need (this does NOT pertain to Lyrica for neuropathic pain)
Which controls is not required to be entered on CURES?
- c5's - c4 with 48 hour supply or less
Who may NOT own a pharmacy?
- caliornia licensed prescibers - person married to a CA licensed prescriber where title is vested by both parties - corporation seeking ownership where 10% or more of stock is owned by CA prescriber
Which drugs were recently added/changed to become a controlled substance?
- carisoprodol (Soma), c4 - Tramadol (Ultram), c4 - Pregrabalin (Lyrica), c5 - hydrocodone/acetaminophen (Norco), c2
training requirements for administering immunizations
- certified in basic life support - immunization training - document all vaccines administered - *1 hour CE every 2 years* focused on immunization and vaccines - protocol with prescriber
Pharmacist in Charge (PIC)
- change in PIC notify BOP within 30 days - max 2 pharmacies within 50 miles - cannot serve as PIC and rep in charge for wholesaler or vet food animal drug retailer interim PIC: 120 days
sterile drug compounding attire for compounding from 1+ nonsterile ingredients
- clean room garb: head cover, face mask, shoe cover at all times (must be removed outside designated area) - hand, finger, and wrist jewelry must be removed. if it can't be removed, must be thoroughly cleaned and covered with sterile gloves - head and facial hair must be covered - gloves of low shedding materials required
Facility standards for sterile compounding
- clean rooom and work stations - ventilation for clean room - records maintained for 3 years - sink with hot and cold running water located in the anteroom - refrigerator and freezer with backup plan in the event of a power outage
When can a RPh place false or misleading info on a prescription label?
- clinical or investigational drug program approved by FDA or legitimate drug project - if appropriate proper treatment of pt (ex: placebo if MD fearful for addiction)
Compounding self assessment
- completed by PIC - every 2 years before July 1st of each odd numbered year - within 30 days of start of new PIC - within 30 days of issuance of new pharmacy license
gloved fingertip sampliing
- compounding personnel lightly press each gloved fingertip and thumb on growth media andn intubate for a period of time and examined for growth of microorgnisms
What if there's an error on a control prescription?
- contract prescriber - receive clarification, - mix mistake on rx - document that prescriber was notified if prescriber did not SIGN or DATE in their own handwriting in ink, new rx is required
Which types of medications cannot be filled for a 90 day supply if the prescription was written for a 30 day supple and there are remaining refills
- controls - psychotropic prescriptions
What are the new requirements for outpatient prescription drug coverage?
- copayment for an outpatient prescription shall NOT exceed $250 per 30 day supply - requires insurance to cover outpatient prescriptions medically necessary including formulary and non-formulary drugs
When can you release medical information without consent from patient?
- court order request, subpoena - request by BoP, commision, or administrative agency - request by arbitrator for arbitration hearing - search warrant issued by law enforcement agency - request from coroner in course of an investigation
what needs to be recorded for refills
- date refilled - name or initials of RPh - qty - brand name or generic with manf
What should be included in the *Quality Assurance Report*?
- date, location, and participants (*does not need to state names*) - pertinent data - findings and determinations - recommended changes to policy or procedures - stored and maintained for *1 year*
Drug Diversion Law
- discourage resale of drugs by a non-profit pharmacy to a for-profit pharmacy
Quality Assurance Program
- documents med errors attributable to pharmacy and its personnel - Purpose: to assess why errors occur, maintain records, take necessary steps to help eliminate or reduce occurrences - investigation no later than *2 business days*
Can hypodermic needles/syringes be sold OTC?
- does NOT require record book - person known to by the furnisher to have previously been provided a prescription or other proof of legitimate medical need - to prevent spread of HIV, viral hepatitis, or other blood-borne diseases AND 18 yo + - for use on animals if known to the furnisher
labeling for extemporaneous unit dose packaging
- drug name/strength - dosage form - lot number - exp date, not to exceed 1 year if centralized hospital, must be within 75 miles and requires bar code
Delivery of dangerous drugs and devices if pharmacy is closed
- drugs placed in locked/secure storage facility - only PIC or designated RPh has access to storage facility and has means of indicating whether it has been entered - written policy and procdures - documented invoices must be left with delivery
What if an e-script transmission fails?
- e-script app may print rx only if designated pharmacy notifies the prescriber that e-script was not delivered - printed rx must note that rx was originally transmitted electronically with date and time, and that transmission failed - app musst not allow transmission of e-script if original rx was printed prior to attempted transmission - if both electronic and written rx received, pharmacy must mark one as void
Protocol for RPh furnishing naloxone
- educate patient - notify PCP - protocol must be already established - RPh may not administer naloxone
requirements for Automated Drug Delivery System (ADDS) for community pharmacy setting
- emergency drug supply unit limited to 72 hour supply or less - dispensed upon authorization of rph - reviewed and maintained by rph monthly - required to notify Dept of Public Health Services
Rx price information
- employee MUST give current retail price for any drug sold upon request if 5+ rx drugs requested, - pharmacy may require request in writing - respond within a reasonable time (10 days) - pharmacy may charge reasonable fee for each price quote but pt must be informed before or when info is given and charge is to be included in price for the rx if filled at the pharmacy request was made - pharmacy shall NOT be required to respond to *more than 3 requests* from any one person or entity in a 3 month period
How are c3-5 to be inventoried?
- estimate count or measure may be taken - if container holds more than 1,000 units, an exact count must be taken if opened
What must be done when furnishing travel meds
- evaluate pt - destination criteria - risk assessment - notify PCP of drugs furnished within *30 days* - provide pt with progress note
What must be done when furnishing nicotine replacement products?
- evaluate pt (tobacco use, pregnancy, heart attacks, angina, etc) - recommend helpline - notify PCP - store records for 3 years
How frequently must c3-5's be inventoried?
- every 2 years
How often should controls be inventoried?
- every 2 years for c3-5 - every 3 months for c2s
How frequently must c2's be inventoried?
- every 3 months - if there's a new PIC, inventory must be completed within 30 days - if there is an automated drug delivery system, c2 must be reviewed every month
e-prescription
- for non-controlled and c3-5 - does not need a hard copy printed - can be stored electronically
When is the DEA 222 form used?
- for ordering c2 drugs - for transferring c2 drugs
When can a control be on a regular prescription blank?
- for terminally ill patient with rx stating "11159.2 Exemption"
When is dispensing ephedra prohibited?
- for the purpose of weight loss, muscle building, and athletic performance
Emergency Supply of non-controls
- full refill or reasonable quantity
Tech check tech program
- general acute hospital with ongoing clinical pharmacy program where pharmacists are deployed to inpatient care areas - orders have to be previously reviewed and approved by pharmacist - compounding and repackaging ust be checked by RPh before used for filling patient orders - techs require specialized and advanced training for this program
sterile drug compounding attire for cytotoxic drugs
- gown and gloves
Methadone is prescribed for what kind of addictions?
- heroin and other narcotics
Requirement for to be licensed pharmacy technicians
- high school graduate or GE certificant equivalent PLUS one of the following: - associate's degree in pharmacy tech - complete course of training (at least 240 hours of instruction covering pertinent material) - graduated from a school of pharmacy - certified by the Pharmacy Technician Certification Board
Rx label requirements
- highlighted in color using bolder or larger type enclosing in a white box area - white box: pt name, drug, strength, directions, purpose - white box must be 50% of the label - printed in *12 point* sans serif font
When can a prescriber dispense rx to an ER patient?
- hospital's outpt pharmacy is closed, and no RPh available in hospital - drug is acquired by hospital and record kept by pharmacy - pharmacy outside hospital is not available to provide rx - amount dispensed from ER *shall not exceed 72 hour supply*
What is required by law for consultation of new prescriptions?
- how to use - importance of compliance - storage - common sereve ADRs and/or drug interactions
When do settlements need to be reported to the board?
- if RPh must pay out $3,000 or more as a result of pharmacy related matter - within 30 days after settlement - must be signed by each of the parties
Federal sale for ephedrine-like products
- if a person purchases a single package containing 60 mg of pseudoephedrine, the purchaser does not have to provide identification or sign logbook THIS DOES NOT APPLY TO EPHEDRINE OR PHENYLPROPANOLAMINE
When can a sample prescription drug be stored and dispensed from a pharmacy?
- if another health care entity acting under a licensed physician transfers it to the pharmacy for dispensing to patients - if prescriber requests that the manufacturer or distributor distribute drug samples to a pharmacy by mail or common carrier
when can a prescriber dispense drugs directly to pt?
- if in his office - samples: in packaages prepared by manfacturer and not paid for by patient - written disclosure stating pt can get it from prescriber or pharmacy of pts choice
Criteria to classify a patient as "terminally ill"
- incurable and irreversible disease - death is projected within 1 year - c2 is for control of severe pain, symptom management, or both. NOT for cure of illness
A pharmacist is authorized to tell a patient what when taking blood pressure:
- inform pt of results - render opinion whether reading is high, low, or normal range - advise pt to consult physician
How is naloxone available?
- injectable - nasal preparatioin
What facilities are patients able to be treated for their addiction with control substances under the state government program?
- institution approved by State Dept of Mental Health where pt is under restraint and control at all times - city or county jail - state prisons - facility licensed by State Dept of Mental Health - state or city hospital - facility licensed by the State Dept of Alcohol and Drug Program
Records for extemporaneous unit dose packaging
- kept in ledger - date, preparing pharmacy - initials of rph - lot #, amnt of drug used - name and strength - manf name - exp date, cannot exceed 1 year
security control blanks contain what features
- latent, repetitive VOID on entire front when scanned or photo copied - "California Security Prescription" watermark on backside - chemical void protection - thermochromic ink - opaque writing disappears if lightened - 6 check off boxes for quantity and ____ for units - check boxes for number of refills - multiple prescription form needed if more than 1 control - SP# (security printer number)
Off label use is allowed if:
- life threatening condition - chronic and/or disabling condition, interfering with 1 or more life activities and condition persists for years
Optometrists authority to prescribe
- limited authory - must have a T at the end of their license number to prescribe (TPA certified) topical anti-allergy, topical anti-inflammatory, topical or systemic steroids, oral/systemic glaucoma meds (18+ yo), oral antihistamines, oral antibiotics, topical antiviral, oral acyclovir, codeine with non-scheduled analgesic
What can a surgical clinic dispense or administer?
- limited to the use of drugs for administration for surgical procedures and control of pain and nausea - take-home meds, no more than 72 hour amount - c2 canNOT be dispensed, only administered on site - consulting RPh required
Requirements for labeling of unit dose labels for centralized drug preparation
- lot number - machine readable barcode to verify meds given is correct med, dosage, and route
Required documents for compounded drugs
- master formula record - date compounded - personnel who compounded drug - RPh reviewing final product - quantity of each component - manufacturer, expiration dates, and lot numbers of each component - rx number - exp date - final quantity compounded
How many refills allowed for C3-4?
- max 5 refills - within 6 months - refills may not exceed a 120 day supply total
Pharmacy Ethics Course
- may be required based on pharmacy relation violation - duration: min 22 hours, 14 contact hours, at least 8 hours credited for prepartion, eval, and assessment - class size: shall not exceed 12 participants - records: maintained for a min 3 years completion: provider notifies board in writing within 10 days.
E-prescribed Rx
- may be stored electronically for up to 3 years - controls allowed if both physician and pharmacy are registered - physicians address, license classification, and federal registry number or address of pt can be omitted if info is on file and readily retrievable by pharmacy
Furnishing Emergency Contraceptive (EC) per protocol
- may charge up to $10 administrative fee - refer pt to PCP - dose within 120 hours of unprotected sex - may be divided into 2 doses with second dose taken 12 hours after first dose - inform pt of adjuctive meds for nausea and vomiting - may provide EC to patients under 18 yo
Naturpathic Doctor (ND) authority to prescribe
- may work with licensed physician under protocol for non-scheduled or schedule *3-5*. - MD can only supervise up to 4 NDs at a time - must have "NDF" in order to prescribe - must be registered with DEA to prescribe controls under MD without MD: - epi for anaphylaxis - natural or synthetic hormones (not including testosterone)
Can you release rx info to a parent?
- minor's rx records are protected by the minor's own private information. - only released pending minor's consent - confidentiality may dissipate for a minor under 15 and parents are paying for child's medical care and rx's.
Unapproved compounded drugs
- mixing of one or more drugs prepared by the dispensing pharmacy and not necessarily recognized as an official drug formulation by the FDA
Drugs/Drug classes included in the may impair ability to drive
- muscle relaxants - analgesics - antipsyc - antidepressants - antihistamines - motion sickness/antinausea - antipruritis - anticonvulsants - ALL C2-5 - anticholinergics
Sale of dextromethorphan
- must be 18 yo + - requires picture ID with name and DOB for age verification - violation not to exceed $250
transferring c3-5 rx
- must be done over the phone - only transferred to another pharmacy ONE time - must have DEA of transferring pharmacy
pt profile records
- must be kept for *1 year* - unless RPh has reasonable belief that pt will not continue to obtain rx meds from pharmacy
Records of drug selling/borrowing/lending/buying between pharmacies
- must be kept for 3 years - schedule 2: must be executed on a DEA Form 222
Oral Rx
- must be reduced to writing - stored hard copy - no C2 UNLESS under emergency circumstances
Non-resident drug whole saler or distributer
- must be registered by BoP
Can clinics stock and dispense drugs
- must be registered by BoP - may dispensed by physician or pharmacist - keep records for 3 years - no C2's dispensed by clinic (must write rx to be filled at pharmacy or must administer from ordered supplies) - consulting pharmacist must visit clinic quarterly each year
Secured Container Units in a pharmacy
- must be within close proximity to pharmacy - allows pts to drop-off their rx (new or refillable) whether pharmacy is open or closed - pts may drop off or pick up rx that have previously refilled, where there is NO requirement for pharmacist's consultation - pt must sign a written consent to participate - box meets inclusion criteria - box must have means to identify each pt and only release that pt's rx - written policies and procedures
requirements for repackaging already dispensed rx
- name and address of pharmacy repackaging drug - name and address of pharmacy who dispensed drug
Non-required consultation points
- name of drug - route - dosage and duration - special directions - how to prepare for administration - self monitoring - methods of avoiding severe SEs actions to take if SE or drug interaction - missed doses
Flu and Pneumococcal immunization in SNF
- needs SNF medical director approval - pursuant a standing order
Poison Schedules
- no longer exists in CA - poisonous substances have been replaced with safer and generally more effective drug substances - generally no longer sold in pharmacies with the occasional exception of boric acid
Ephedra
- no longer legal in the US
When type of error would require a new rx for a control prescription?
- no prescriber signature - date is not written in prescribers hand writing
What is prohibited during RPh temporary absence from pharmacy?
- no rx meds may be proided to pt unless rx is a refill already checked and approved for release and does NOT require consultation - staff may continue to perform non-discretionary duties - intern shall be considered ancillary staff and may not perform any discretionary duties - RPh is NOT required to remain in pharmacy area during their break
faxed prescription
- non-controlled only - if c3-5 is faxed, RPh must hand write and call MD for verification
Hospitals with 100 beds or fewer
- not required to have a FT RPh - hospital must be registered by BoP - must employ a *consultant rph*
What does a pharmacy do if they are discontinuing or transferring their business and has c2's?
- notify DEA in writing at least 14 days in advance of the proposed date - on the day of transfer/discontinuance, a complete inventory shall be taken of all controls and maintained by both transferor and transferee
What must be done when administering immunizations?
- notify PCP - report to pts vaccination to state system within *30 days*
DEA requirements for storage of electronic prescriptions
- once rx is created eletronically, all records of the rx must be retained electronically
POA for community pharmacies
- one individual (does not have to be a pharmacist), registers with DEA as POA - POA can assign POA status to another individual in their absence only person with POA status may place c2 order
PRN refills
- only allowed on non-controls
Requirements for centralized drug preparation
- only to hospital operations mutually owned and within 75 mile radius from each other - must obtain specialty license - license renewed annually
How can a prescriber express that they do not allow substitution?
- orally stating to a RPh - stating in hand writing - checking the box on the rx, AND *initial* next to the checked box - stating on a e-script
Requirements for pharmacy tech trainee
- participate in externship program for not more than 120 hours in community or outpatient pharmacy, and not more than 200 hours in hospital pharmacy - externship must not exceed 6 consecutive months in community pharmacy and not to exceed 12 months for combined community and hospital experience
Advanced practice pharmacist may do what?
- perform patient assessments - order and interpret dru therapy related tests - refer pts to other health care providers - evalute and manage disease and health conditions with other health care professioners
Permit for hospital to dispense drugs
- permit must be from state board - annually renewed on or before November 1st of each year
who can call for refills on non-controlled medications
- pharmacist - intern - tech - clerk
Who may sign for ordered drugs from wholesaler?
- pharmacist - pharmacy intern
Names exclusively restricted to a pharmacy operation
- pharmacy - apothecary shop - drug store - medicine shop - Rx etc. if pharmacy operation is structure as a corporation, the nomenclature may be used but the business entity must be identified as a corporation as part of its title
What happens if the pharmacy does not have sufficient quantity to fill the prescription?
- pharmacy may fill for what they have in stock - balance must be filled within 72 hours - if not filled within 72 hours, new rx is required - prescriber must be notified if partially filled
permits to operate a pharmacy
- pharmacy permit from BoP for each site - renewed annually and shall not be transferable if new owner - Board licensed personnel are NO LONGER required to display their individual issued state BoP licenses DEA permit - to buy anad dispense coantrols Sterile injectable compounding - license from BoP renewed annually
When can a c2 be partially filled?
- pharmacy receives a rx for a terminally ill patient OR - patient is confined to a hospice or skilled nursing facility rx with refills are only valid for up to 60 days
When can a c2 be filled for less than when it was written for?
- pharmacy's supply is less than the quantity written for - patient requests a smaller amount - pharmacy receives a rx for a terminally ill patient confined to a hospice or skilled nursing facility note: prescriber must be notified if quantity is filled for less than the rx
OTC emergency contraceptive products
- plan B (2 tablets) - plan B 1 step (1 tablet)
requirements for sterile compounding staff
- practical skills training in aseptic technique and aseptic area practice - evaluation must include written testing - proficiency and continuing training bust be reassessed every 12 months
Emergency order requirements for c2
- prescriber must call pharmacy - security prescription within 7 days
In what conditions can a pharmacist dispense Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) to treat addiction?
- prescribing physician must have completed 8+ hour of authorized training in management of opioid-dependent patients for c2-5 addictions - prescribing physician must have a second DEA # with the A or B in their DEA # replaced with an "X" - physician is limited to treat only 100 patients at one time - NP or PA may not prescribe
exceptions for when a RPh may acquire a drug from another pharmacy nd sell the drug on presction at his or her usual price:
- prescription if for person's own use - lower cost drugs are sold to purchaser for prices under the nonprofit institutional act - sold to a walk-in customer pursuant a prescription - drug is not readily available pursuant a emergency rx
requirements of rx after filled and before filing
- prescription number - date filled - initials of dispensing rph - brand name or generic and manufacturers name price charged to pt is *not required*
CA Labor Laws
- prevents RPh from working more than *108 hours* (or 12 days) in any 2 week period overtime: - any work performed beyond 8 hours/day or 40 hours/week - 1.5x pay beyond 8 hours per day or 40 hours per week - 2x pay beyond 12 hours per day
2 circumstances where Rph does NOT have to provide oral consultation
- previously filled as written - patient refuses consultation
drugs compounded for a prescriber's office
- reasonable quantity may be prepared for prescriber's office for administration/application IN THE OFFICE - prescriber may provide patient NOT MORE THAN 72 HOUR SUPPLY to take home
sale of ephedrine-like products
- regulated behind the counter or in locked cabinet - must be 18 yo + - requires picture ID - log books required (electronic or written) - daily limit = 3.6 g - monthly limit = 9 g - violation - misdemeanor or felony charges
What can pharmacy techs do?
- remove drug from stock - count, pour, or mix - place product in container - affix label to container - package/repackage product - call for refills on a non-expired prescription with no refills
If rph declines to fill a rx and BEFORE he decides it is fraudulent what can he do with the rx?
- retain it - return it - copy it and return it - give 3 days worth until can speak to doctor (not CII)
Buprenorphine is prescribed for what kind of addictions?
- schedule 3-5 addictions
What must be done when furnishing naloxone?
- screen pts - counsel pt - refer pt to seek further help - help recipient choose product (IM, autoinjector, intranasal spray) - provide fact sheet - notify PCP - maintain document for 3 years
limits to emergency supplies as ward stock in health care facilities
- shall be made available to each nursing station within the facility - shall be placed in secured storage areas - kept in secure place - limits the # of oral dosage form or suppository drugs to 48 at any given time. - not more than 16 doses of any separated drug dosage form - not more than 4 of the 48 oral form or suppository form drugs shall be psychotherapeutic drugs (can be 10 upon Dept of Public Health approval upon need of pt population
Mobile Pharmacy during declared state of emergency
- shares common ownership with at least 1 currently licensed pharmacy - retains records - licensed RPh on premises when rx dispensed - reasonable security - located within declared affected emergency area - mobile pharmacy ceased within 48 hours of termination of emergency
parenteral drugs allows to be furnished for home health or hospice
- sodium chloride - urokinase - dextrose - heparin - epi - diphenhydramine - methylprednisolone - NS - naloxone - droperidol - prochlorperazine - promethazine, - glucagon - insulin - bumetamide - furosemide - EMLA cream - lidocaine
What if a OTC product does not have a expiration date?
- stable for at least 3 years
training requirements for furnishing Emergency contraception
- state or physician-directed protocol - at least 1 hour CE on Emergency contraception drug therapy
When is a pharmacy not obligated to provide drug prices?
- telephone request for controls - request from a competitor - request from an out-of-state requester
RPh Spouse active duty
- temp CA RPh license valid up to 12 months if license in another state in good standing
If a married couple wants to own a pharmacy but prescriber is a prescriber
- title must be held as the sole and separate property of the non-prescriber spouse and a separate bank account must be maintained.
Retired License
- to regain active license, must fulfill requirements of new application for licensure including taking NAPLEX and CPJE
training requirements for furnishing travel medications
- travel med program of at least *20 hours* - CDC yellow fever vaccine course - basic life support - CE: 2 hours focused on travel med q2years
Duties of pharmacy clerk
- type a prescription label - request and receive refill authorization - stock drugs - answer phones - ring up prescription
How can the DEA 222 forms be filled in?
- typewriter - pen - indelible pencil
Certified Nurse Midwives (CNM) authority to prescribe
- under supervising MD protocol - may register with DEA for controls c2-5 - may not furnish rx's for their own practice scope of practice: family planning, perinatal services, routine health care to essential healthy persons, abx for sexual partners, childbirth deliveries
Certified Nurse Practitioner (CNP) authority to prescribe
- under supervision of MD - furnish c2-5 with MD protocol and register with DEA
Nurse Practitioner (NP) authority to prescribe
- under supervision of MD - furnish c2-5 with MD protocol and register with DEA
Physician Assistant (PA) authority to prescribe
- under supervision of MD - furnish c2-5 with MD protocol and register with DEA
Inactive license
- up to 3 years - prohibited from practicing - nenewed q2years by paying renewal fees - no CE required until wanting to become active - if RPh fails to complete 30 hours of CE within 15 days of being notified
Offsite Storage of Pharmacy Records
- waiver must be granted by BoP Requirements: - secure from unauthorized access - confidentiality of records maintained - produce requested records within 48 hours (2 business days)
time period for use of any single dose container
- within 1 hour in environment with air quality worse than ISO Class 5 - within 6 hours within ISO class 5 conditions
Schedule 3-5 can be transferred to a pharmacy how?
- writing rx on security form - e-prescribing if both pharmacy and prescriber are registered
requirements for use of automated drug delivery systems in clinics
- written policies for use, maintenance, and security - RPh consult via telecommunication with 2 way audio and video capabilities - RPh review prescription before release - RPh must be in California - RPh stocks, inventory control and reviews and maintains system - monthly inspection
BUD for unit dose containers:
-1 year from date drug is repackaged, OR -exp date on msg's container **whichever is sooner**
Controlled Freezer Temperature defintion
-25 degrees to -10 degrees centigrade (-10 to -30 degrees fahrenheit)
Services APh can perform
-Administer drugs/biologics -Initiate/adjust/dc drug therapy (controls with DEA registration) -Self-administered hormonal contraceptives, rings, injections -Travel meds (not requiring diagnosis) -Nicotine replacement products -Independenly administer immunizations (per CDC) -Order and interpret tests
Patient Counseling must include... at minimum (3)
-Directions for use and storage -Importance of compliance -precautions and relevant warnings (common, severe SE)
Med Guides required for these classes of drugs -adverse events when taken with alcohol (3)
-Disulfiram and other drug causing disulfiram-like Ron (chlorpromide, metronidazole) -MAOI -nitrates
Clustered into 50% of the medication bottle label (4)
-Patient name -Drug name (Brand or (generic + mfg)) AND drug strength -Directions for use -Condition or purpose of the drug in this rx
Used to treat PCP? 3 options
-SMZ/TMP (Bactrim, Septra) -pentamidine (Pentam, NebuPent) -atovaquone (Mepron)
Examples of REMS programs -birth defects (3)
-Thalomid REMS (previously STEPS): (-) preg test required -iPledge (isotretinoin): (-) preg test required -Qsymia (phentermine/ topiramate - wt loss) REMS: only dispensed through certified pharmacies
What are Security Forms required for?
-all CS -all Medi-Cali outpatient prescriptions (including OTC, non-controlled, and CS)
With additional training, pharmacist can administer:
-drugs and biologics when ordered by prescriber (oral, topical, injectable) -sell self-administered hormonal contraceptives -sell travel meds recommended by CDC and do not req diagnosis (ex: anti-malarial rx) -sell nicotine replacement produts -independently initiate and adminster immunizations published by CDC to *3+yo* -order and interpret tests, in coordination of PCPC
A pharmacist can only supervise ______ tech trainee for up to ____hours
1 Tech trainee for up to 120 hours.
training requirements for furnishing hormonal contraception
1 hour CE every 2 years
What are the CE requirements for furnishing Naloxone?
1 hour every 2 years
What are the CE requirements for furnishing hormonal contraception?
1 hour every 2 years
What are the CE requirements to administer vaccines?
1 hour every 2 years
Pharmacist: intern: tech: tech trainee ratio
1 pharmacist can supervise 2 interns 1 pharmacist can supervise 1 tech Each additional pharmacist can supervise 2 techs Ratio NOT needed if tech is NOT typing/filling Pharmacist may request less techs to supervise 1 pharmacist can supervise 1 tech trainee NO ratio for pharmacy clerk!!!
After approved waiver, how long do non-CS rx records need to be stored in the pharmacy before moving off-site?
1 year
How long is a non-controlled rx good for?
1 year
How long to keep md error/QA reports
1 year
How long to keep pt med profile
1 year
MEDICATION ERROR/quality assurance reports
1 year
QA reviews records maintained on premises when
1 year
What is the expiration date for extemporaneous unit dose preparations?
1 year
What is the refillable zone for non-controls?
1 year
What is the time limit requirements in the keeping of pharmacy records for *patient medication error documentation records*?
1 year
How long must a patient's profile be kept in the system?
1 year from the date of last filled prescription.
Expiration date for extemporaneous unit dose preparations
1 year or less if manufacturer's date is less than 1 yr
Expiration date for extemporaneous prepared unit dose packaging?
1 year or manufacturers exp date
Self administered hormonal contraceptives 1. Requirements to furnish 2. When to have patient complete a self-screening form 3. When CI 4. When to refer pt/nearby clinic instead of furnishing 5. Measure and record patient's seated ___if using estrogen 6. Provide patient with 3 fact sheets
1. 1 hour of CE + application of US Medical Elgibility Criteria (USMEC) for contraceptive use and other contraception or curriculum based training 2. Initially and annually, whenever pt indicates major health change 3. hx of breast cancer, heart dx, DVT, tobacco use 4. DDIs with antiepileptics 5. BP 6. BC guide, PPI, administration fact sheet
Prescriptions expirations and refills 1. Non scheduled 2. Schedule V 3. Schedule III, IV 4. Schedule II
1. 1 year; no refill limit; prn refills acceptable 2. 6 months, no refill limits, no prn refills for any CS 3. 6 months, 5 refills within 6 months + all refills combined cannot exceed a 120 day supply (original fill does NOT count as a refill) 4. No refills
CE Requirements for extra RPh stuff 1. Administering immunizations 2. EC 3. Self-administered Hormonal Contraceptives 4. Naloxone 5. NRT 6. Travel meds
1. 1-hr CE Q2yrs, CDC/ACIP approved immunization program, BLS 2. 1-hr CE 3. 1-hr CE, application to USMEC 4. 1-hr CE 5. 2-hr CE Q2yrs 6. 2-hr CE Q2yrs, immunization cert program, travel med training program (10+ hrs), Yellow Fever VAX Course, BLS
If a recall of a compounded product was dispensed for use in CA, and the recall involves product that could cause serious ADR or death.... 1. contact recipient pharmacy/patient/provider within... 2. contact BOP within...
1. 12 hours 2. 24 hours
Outsourcing comopund recalls 1. Contact pharamcy/provider/patient within... 2. Contact BOP in..
1. 12 hours 2. 24 hours
1. Normal BMI 2. Waist circum goal for women 3. Waist circum goal for men
1. 18-25 2. <35 3. <40
Pharmacist can supervise # 1. Interns 2. Technicians A. Community setting B. Hospital setting 3. Pharmacy technician trainee 4. Pharmacy clerk
1. 2 at a time 2. A. 1 technician is permitted for first pharmacist; 2 techs are permitted for each additional pharmacist B. 2 techs per pharmacist 3. 1 at a time, up to 120 hours 4. No maximum number
Nonprescriptions products with restricted sales - maintain logbook for 2 years 1. Pseudoephedrine (Sudafed) OTC day limit 2. Pseudoephedrine (Sudafed) OTC day 30 day limit 3. Pseudoephedrine (Sudafed) OTC day 30 day mail limit 4. Pseudoephedrine (Sudafed) OTC how many packages per transaction limit 5. Dextrometorphan age limit
1. 3.6 g/day 2. 9 g 3. 7.5 g 4. 3 packages per transaction 5. 18+ to buy if no prescription + ID
Pseudoephedrine "OTC" sales 1. Max per day 2. Max per month 3. Max # boxes per transaction 4. storage? except? Where can ephedrine be found?
1. 3.6g/day 2. 9g/month 3. 3 boxes/transaction 4. behind counter. Except pseudoephedrine 2 x 30mg caps single use. Asthma products
To stay a licensed pharmacist 1. How many hours of CE how often 2. After 7/1/2019, what kind of CE must be included 3. License expires when 4. What license is exempt 5. How long keep certificate of completed CEs for 6. What must be disclosed on license renewal forms
1. 30 hours in each 2-year licensing period 2. at least 2 hours of pharmacy law and ethics 3. last day of the pharmacist's birth month 4. First 2-year license is exempt from CE requirements 5. 4 years 6. Any disciplinary action against their license or violations of law (except minor traffic ones)
1. Emergency situation where drug must be administered immediately, prescriber can issue verbal order and prescriber has ___ hours to physically or electronically countersign the order 2. Records of monthly inspection of drug supply must be kept for (HA drug supply in ADM, refrigerators, emergency supply, etc must be inspected every 30 days) 3. Reporting time limit for irregularities of hospital drug supply and to who 4. Documentation of actions related to lab tests (med changes, interpretation of results, rationale, etc) 5. Furnishing naloxone, NRTs, EC 6. Paper DEA Form 222 - when must supplier report transaction to DEA 7. CSOS - when must supplier report transaction to DEA
1. 48 hours 2. 3 years 3. 24 hours - report to PIC and director/CEO of healthcare facility 4. 24 hours 5. Keep record for 3 years 6. By the end of the month during which the order was filled 7. Within 2 business days of filling the order
Upon written request, patient records: 1. Pt can inspect their medical records within... 2. Receive copies of their medical records within...
1. 5 business days. 2. 15 business days.
Valid rx good from written date: 1. Controlled substances 2. non-controlled
1. 6 months 2. 1 year
Maintained for at least: 1. Hospital pharmacy chart order records for controlled substances 2. Patient acknowledgement if HIPAA 3. Transaction information, hx, statement for more prescription drugs as required under the Drug Supply Chain Security Act 4. Certificate of completion for continuing education 5. Biennial controlled substance inventory 6. Community or clinic pharmacy prescriptions
1. 7 years 2. 6 years - separate from other signatures obtained by pharmacy 3. 6 years from date of transaction 4. 4 years 5. 3 years 6. 3 years
1. Emergency filling of schedule 2 Rx, prescriber must provide original prescription (written or electronic) by __ of fill date 2. If doesn't receive above, must report to who (2 parties) and when 3. Must report to Board within ___ if they suspect another pharmacist is impaired at work 4. Must report significant losses/theft to local DEA office in writing within ___ of discovery 5. Off-site storage of non-CS records time 6. Off-site storage of CS records time
1. 7th day 2. CA Bureau of Narcotic Enforcement within 144 hours & DEA 3. 14 days 4. 1 business day 5. 1 year at pharmacy, then off site for 2 years 6. 2 years at pharmacy, then off site for 1 year
Senate Bill 493 --> advanced practice pharmacist 8 expansion of scope
1. Administer drugs and biologics > oral and topicals 2. Provide consultation, training, education about drug and dx management 3. Participate in multidisciplinary reviews of patient progress with access to med records 4. Furnish hormonal contraceptives 5. Furnish travel medications recommended by CDC and do not require diagnosis 6. Furnish Rx nicotine replacement products 7. Initiate and administer immunizations for pts 3+ 8. Order and interpret tests
Partial Fills 1. non-CS, CS 3, 4, 5 For C2, deadline for remaining balance to be filled 2. CS 2 Pharmacy does not have sufficient stock of a drug 3. CS 2 Partial filling of an emergency oral Rx 4. CS 2 Partial fill is requested by the patient or the practitioner that wrote the Rx 5. CS 2 Partial filling for terminally ill patients or SNF residents 6. Partial filling for LTCF residents
1. Allowed prior to Rx expiration. Partial fills are NOT considered refills 2. 72 hours 3. 72 hours 4. 30 days 5. 60 days 6. 60 days
What can a prescriber prescribe to: 1. himself? 2. His family?
1. Any non-controlled med 2. Any non-controlled or controlled med
Rx Transfers 1. Non-controlld 2. C3-C5 3. C2
1. Can transfer as many times as there are refills remaining 2. one transfer, unless sharing a computer EMR system (CVS-->CVS) 3. No transfers
Poison prevention Packaging Act (PPPA) 1. What does it require 2. Prescribers can waive vs patients can waive
1. Child resistant container for OTC, Rx, and household chemicals. Mandates new plastic containers and tops must be used for each prescription dispensed (If a glass container is used, only top plastic closure needs to be replaced) 2. Prescribers can waive C-R container for single prescription vs patients can provide a blanket waiver
1. DOC. SE: pruritus ok in pregnancy 2. Plaquenil; HD for RA/autoimmune cause blurred vision, blue-gray skin pigment**take weekly for malaria PPX 1-2 wks before and 4 wks after 3. SE. cinchonism which resolves when med is dc'ed. OD leads to cardiotoxicity. Monitor for hypoglycemia 4.Lariam: CI if neuro/psych; medGuide; ok in pregnancy 5. SE: hemolytic anemia with G6PD deficiency. CI in pregnancy
1. Chloroquine=2. Hydroxychloroquine=3. Quine and quinidine=4. Mefloquine=5. Primaquine
Written Info Provided to Patient
1. Consumer Med Info (CMI) leaflets 2. Patient Package Inserts (PPI) 3. Medication Guides (MedGuides)
DEA Form 222 1. Supplier keeps 2. DEA keeps 3. Purchaser keeps
1. Copy 1 (brown) 2. Copy 2 (green) 3. Copy 3 (blue)
1. Where can dextromethorphan be found? 2. schedule 3. sales?
1. Cough syrups (Delsem, Robitussin) 2. not - OTC 3. must be 18+yo - req's ID
Reporting loss or theft of CS 1. Report to who and when 2. Complete what form 3. Report all CS drug losses to the CA BOP when if licensed employee theft vs when for any other type of loss
1. DEA in writing within 1 business day 2. DEA Form 106 (can first fax/mail short statement and submit 106 after investigating what happened) 3. 14 calendar days 30 calendar days
Pharmacist in Charge (PIC) 1. Responsibilities, liabilities 2. Supervise how many pharmacies 3. Change of PIC if reported by who (2 parties) and when 4. Duty every 2 years + additional form must be completed within 30 days if
1. Daily operations, following laws, Strict liability even if PIC does not know of violation 2. 2 pharmacies within 50 driving miles of each other 3. Pharmacy + departing PIC within 30 days 4. Complete a biennial self-assessment form for their pharmacy before July 1st of each odd numbered year -Additional self assessment form must be completed within 30 days if: 1) new permit, 2) new PIC, 3) pharmacy moves location -Keep self assessment form for 3 years at pharmacy
Mid-level prescribers (RPh, CNM, NP, PA) 1. Prescribing authority 2. Who can treat opioid addiction?
1. Dependent: C2-C5 2. NP, PA - do *not* need to register as opioid tx program (form 363)
1. Hydrocodone Bitartrate ER; 2. +APAP 3. chlorpheniramine and hydrocodone 4. +IBU 5. +paracetamo
1. Hysingla ER; Zohydro ER; 2. Norco, Vicodin, hycet(+APAP), Lortab; 3. Tussicaps, Tussionex, 4. Vicoprofen, 5. Xodol CII
Prescription transfers 1. Must include (5) 2. Who can do transfers 3. Non-CS # of times 4. Schedule III-V 5. Schedule II
1. Identity of RPh or intern, name and ID of pharmacy store or addresses, original date and last dispensing date, number of refills and date originally authorized, number of refills transferred (remaining refills that have not been dispensed) -Transferring pharmacy marks "VOID" on hard copy -Receiving pharmacy marks "TRANSFER" on it 2. Pharmacists and interns 3. As many times as there are refills remaining 4. One transfer only -Exception:; pharmacies that share a "real-time, online database" - can transfer up to the max refills 5. No refills so no transfers allowed
Exemption for fax CII (able to treat fax as original)
1. If drug is to be compounded for direct admin to patient by parenteral, IV, IM, SC, intraspinal 2. If for residents of long term care facilities transmit rx to the dispensing pharmacy 3. If patient enrolled in hospice program certificed by medicare
Prescribers 1. MD/DO, Dentist, podiatrist (DPM), vet (DVM) 2. nurse midwife, NP, PA 3. Optometrist (OD) 4. Naturopathic Doctors (ND) 5. Pharmacist
1. Independent authority & all Rx including C2 2. Dependent authority & all Rx including C2 3. Independent authority, must be certified with Board of Optometry to prescribe -Will have a letter T at the end of license # to prescribe -Codeine or hydrocodone - containing products can be max of 3 days supply 4. Independent authority fo epinephrine, hormones, vits, minerals, etc when available without a prescription. Dependent for all other meds. -No schedule II -NDF# needed to prescriber 5. Independent only for emergency contraception, hormonal contraception, travel meds, routine immunizations, naloxone, Rx nicotine replacement. All others, including C2, are dependent
Emergency Contraceptives
1. Levonorgestrel 2. Ulipristal (rx only) - Ella 3. High dose OC Dispensed via - OTC - Rx - Furnished by RPh in cali under board protocol (need 1hr CE)
1. Schedule 1 2. Schedule 2 3. Schedule 3 4. Schedule 4 5. Schedule 5
1. MDMA, GHB, heroin, LSD, marijuana, mescaline, peyote -GHB sodium salt form is sodium oxybate (C3) 2. Opioids (meperidine, tapentadol (Nucynta), etc), stimulants (adderal, methylphenidates), *Cocaine*, *Codeine*, Barbiturates (amobarbital, pentobarbital, secobarbital) 3. testosterone, *buprenophine* containing products, *codeine/APAP*, dronabinol capsules, ketamine, sodium oxybate, Butabarbital, Bualbital containing products 4. BZDs, stimulants for narcolepsy (Nuvigil, Provigil), Phenobarb, weight loss meds (Beviq), sleeping meds (Z-drugs, Lunesta, Belsorma), *tramadol* 5. codeine cough syrups, Lomotil, Lyrica, Vimpa, Briviact
Opioid Treatment Programs - DEA Form 363 to register 1. Methadone - what dose & what do patients have to do 2. DATA 2000 - what drugs 3. DATA 2000 - what practitioners must have 4. CARA - what does it allow
1. Methadone 40 mg - Patient must visit clinic every day for min 3 months to receive and ingest med 2. Schedule 3, 4, 5 drugs to treat opioid outside of opioid treatment clinic. -Suboxone: bupre + nalox SL film (C3) -Subutex: bupre SL tab -Probuphine: bupre subdermal implant 3. DATA waived practioner and UIN # (UIN and DEA both have to be on Rx) 4. allows NP and PA to treat narcotic dependence as well
1. Drug repository and distribution program 2. Returned Rx drugs from patients 3. Where can patients dispose of drugs 4. Pharmacies that voluntarily install a collection bin for unwanted drugs from patients need to register with the 5. Who can place drugs into the collection bin?
1. NO CS CAN BE DONATED. drugs unused, unopened, unexpired, and never in possession of pt/public 2. Can never be returned to stock or dispensed to another patient. Pharmacy must dispose of the returned drug properly 3. Law enforcement take back events, collection bin/receptacles, mail back packages 4. DEA 5. ONly the patients themselves. CS and non-CS can both be put into it
Consumer Medication Information 1. Approved by? 2. When to provide to patients
1. NOT approved/reviewed by FDA 2. Can provide useful info to pts with each *new* prescription
Recalls for manufacturers 1. What do pharmacists have do to? 2. Does FDA mandate pharmacy contact the patient? 3. Class I 4. Class II 5. Class III
1. Need to remove drug from all patient care areas and storage locations 2. No; physician is responsible for deciding whether his/her patients are to be contacted 3. use/exposure cause serious consequences --> physician responsible for deciding to contact pts 4. Temporary/reversible consequences 5. not like to cause consequences
Pharmacy clerks 1. Licensed or non-licensed 2. Tasks
1. Non-licensed 2. Type Rx label, enter prescription info, request and receive refill authorizations -Cannot pull drugs from the shelf or fill medications -However, can put the drugs back on the shelf and give pts their prescriptions at the point of transaction
Emergency Contraceptive (a) location in pharmacy (b) age restriction to buy (3) when to take 1. Plan B - One Step (levonorgestrel) 1.5mg tab 2. 2-tab levonorgestrel 3. Ella (ulipristal)
1. OTC isle, no age limit, take within 72 hours of unprotected sex 2. Behind pharmacy counter, 17+, take within 72 hours of unprotected sex 3. Rx only, no age limit, take within 120 hours (5 days) of unprotected sex
Technicians 1. When can tech check tech (TCT) be used?
1. Only hospital settings, not outpatient -Techs must have received specialized training -HA must have ongoing clinical pharmacy program and pharmacists located in the patient care areas -Pharmacist must check compounded and repackaged drugs before a tech can use it to fill unit dose distribution, floor stocks, etc
Paper Rx Record Keeping System for CS
1. Option 1: Three separate files - File for CII dispensed - File for CIII-V dispensed - File for nonCS dispensed 2. Option 2: Two separate files - File for all CII dispensed - File for all other drugs dispensed (CS rx's must be readily retrievable by use of red "C" stamp at least 1 inch high. This is waived if pharmacy has e-rx recordkeeping system)
Automated drug delivery system (ADDS) in nursing facility: 1. What must be in place to have this? 2. What must a pharmacist do? 3. Who can stock the ADDS if the cabinet is stocked in the facility? 4. Who can restock removable drawers (restocking outside the facility)? 5. Register the ADD with the board within ____
1. P&P to ensure patient safety 2. review the order and pt profile prior to drug being removed. 3. RPh only 4. RPh, intern RPh, tech 5. 30 days of installing and annually. Inform BOP in writing if d/c'ing machine.
Converting 30 day supply to 90 day supply 1. Only permissible for non-CS, non-psychiatric meds if these 3 conditions met
1. Patient has completed an initial 30 day supply of drug with no negative effects OR pt previously received same med with 90 day supply 2. Total quantity dispensed does not exceed amount authorized on Rx 3. Pharmacist notifies prescriber of increase in number of days supply dispensed
Format of prescription label 1. 4 items (in the specific order) that must be clustered in one area of the label and comprise at least 50% of label (12 point sans serif typeface). Highlight in bold or color, or use blank space to set off the 4 critical items
1. Patient name 2. Drug name and strength 3. Sig 4. Condition or purpose for drug if this was on the Rx
Prescription Requirements
1. Patient name 2. Patient address 3. Drug (or device) name/qty 4. Sig 5. Date 6. Prescriber info (name, address, number, license class, DEA) 7. Condition/purpose if pt request *If written by a vet, all of the above plus below + kind of animal + owner name/address
Advanced Practice Pharmacist (APh) Role
1. Perform patient assessments 2. Order/interpret drug therapy related tests (collab with PCP) 3. Refer pts to other HCPs 4. Participate in eval and mgmt of diseases and health conditions in collab with other HCPs 5. Initiate/adjust/dc drug therapy pursuant to PCP's order and in accordance with protocol (must register with DEA if dealing with controls)
Pharmacy Selling CS 1. Max amount 2. Must use what 3. Practioners cannot write a ___ to get meds?
1. Pharmacy can sell CS to other pharmacies as long as the total number of dosages units does not exceed 5% of the total number of CS dosage units/year 2. Form 222 3. Rx; practitioner needs to purchase using Form 222 or get from wholesaler
If patient is harmed by outsourcing compounded drug, who to notify and when? 1. Pharmacy is notified 2. Outsourcing facility is notified
1. Pharmacy report to FDA MedWatch within 72 hours, BOP in 12 hours 2. Outsourcing facility report to FDA MedWatch in 15 calendar days, BOP in 12 hours
MDI Metered Dose Inhaler- HFA devices/spacers (aerosol)
1. Prime prior to use (2-3 actuations) 2. Shake well (suspension), except QVAR & Alvesco (solution). 3. Use spacer (or rinse mouth with water) 4. Slowly breathe out fully, hold breathe, and breathe normally 5. Clean the inhaler weekly
Steps to Aid in Dying
1. Pt makes 1st oral request (non english speaking residents can request translator) 2. Pt makes 2nd oral request at least 15days after initial request 3. Pt makes written oral request (can be done any time after 1st request) 4. After all 3 requests are received, MD can furnish drugs directly to pt or send rx directly to RPh. If sending to pharmacy, MD must contact pharmacy first to inform RPh and then MD must personally hand deliver, mail, or e-rx rx to RPh. Pt never handles rx. 5. Pt picks up med from pharmacy or has it delivered 6. Pt can change mind at any time 7. Pt must complete final attestation form w/in 48hrs before taking med to give to attending MD
Medication Error Reporting 1. CA requires all pharmacies to have a ___ program 2. Must inform ___ med error has occurred and should inform them of ____ 3. Must also inform ____ 4. Investigations of pharmacy medication errors must begin within ___ from the date of the medication error was discovered 5. How long the record of QA reviews should immediately be retrieved from pharmacy
1. Quality assurance (QA) 2. Patient; inform pt of any steps that can be taken to avoid further injury 3. prescriber 4. 2 business days 5. 1 year
Compounding pharmacy/outsourcing facility recalls 1. Who do they have to contact within 12 hours? 2. Who do they have to contact within 24 hours? 3. When do they need to contact? 4. What happens if compounding is made aware that pt has been harmed, who and when have to contact? 5. What happens if outsourcing facility is made aware that pt has been harmed, who and when have to contact?
1. Recipient pharmacy, prescriber, or patient (notice made to who drug was dispensed to and they must notify rest of the chain as appropriate) 2. Board of pharamcy 3. Use/exposure can cause serious AE and recalled compounded preparation is for CA 4. FDA MedWatch within 72 hours 5. FDA MedWatch within 15 business days
DEA Form # 1. 224 2. 225 3. 363 4. 222 5. 106 6. 41
1. Registration form for pharmacies, hospitals, practitioners, teaching institutions 2. Registration form for manufacturers, distributors, researchers, analytical labs 3. Registration form for narcotic treatment programs 4. Ordering Schedule I and II 5. Reporting Theft or significant loss of CS 6. Record of CS destroyed
DEA Controlled substances inventory: all pharmacy stock inventory taken every 2 years -Exact or estimated count 1. Schedule I and II require 2. Schedule 3, 4, 5 with 1000 dosages units or less 3. Schedule 3, 4, 5 with 1000 dosages units or more
1. Require exact count 2. Estimated 3. Exact count
Section 503A Traditional Compounding - only regulated by State Board 1. Based on what 2. Can you prepare small batches of compounded prep in advance? 3. Selling to prescriber's office 4. Selling to vet's office 5. 3 exemptions from requirements that apply to Rx drugs 6. Label of dispensing pharmacy 7. Interstate distribution
1. Rx 2. Yes, if dispensing history of the pharmacy supports the need --> label with appropriate BUD 3. Yes can only for administration or application to patient in the prescriber's office (not for dispensing) 4. Vet can order and dispense up to 120 hours supply to their patients 5. 1) complying with FDA's cGMPs, 2) labeling with adequate directions for use, 3) need to complete a New Drug Application (NDA) in order to have the end product FDA approved 6. Must include both compounding pharmacy and dispensing pharmacy 7. Up to 5% of total sales
1. Proventil HFA/Ventolin HFA/ProAir HFA/AccuNeb/Proventil tabs/ Volmax sol=Xopenex HFA=Maxair Autohaler 2. Flovent(Flonase, Veramyst)/Advair=QVAR(Beconase AQ)=Azmacort=Azmacort/Nasacort AQ=Aerospan(Nasarel)/Aerobid=Alvesco=Asmanex(Nasonex)/Dulera=Pulmicort(Rhinocort Aqua)/Symbicort 3. Serevent Diskus/Foradil Aerolizer 5. Intal(NasalCrom) 6. Singular=Accolate=Zyflo CR 7. Elixophyllin, Theo-24, TheoCap, Uniphyl, Theochron 8. Xolair
1. SABA: *Albuterol*preferred in preg, even preg-C *Levalbuterol* *Pirbuterol* SE: tremor, tachycardia, tachyphylaxis (decrease K and Mg, ^ gly) 2. 1st to addL ICS: *Fluticasone/+Salmeterol*(MedGuide) *=Beclomethasone=Triamcinolone=Flunisolide=Ciclesonide=Mometasone/+Formoterol*(MedGuide)*=Budesonide/+Formoterol*(Preferred in preg) 3. 2nd add-on: LABA *Salmeterol**=Formoterol*: 12hr, brochodilator, BBW: asthma-related death. 4. 3rd add-on: *Betamethasone=Dexamethasone 0.75mg;**Methylprednisolone=Triamcinolone,4mg;**Prednisone=Prednisolone, 5mg;**Hydrocortisone, 20mg;* *Cortisone, 25mg* 5. Mast Cell Stabilizer: *Cromolyn*(anti-inflammatory to prevent early/late response to allergens,DOC exercise-induced, 15 mins prior, MDI or NEB, minimal SE but less effective), 6. Leukotriene Rec. Antagonists: *Montelukast*(>6mo, QHS, avoid in PKU)*=Zafirlukast*(>5yr, empty stomach)*=Zileuton*(>=12yr, within 1hr of a meal, monitor liver) 7. *Theophylline*: 3rd line, bronchodilator, narrow therapeutic range>monitoring, Multiple DDIs 8. *Omalizumab* SC q2-4 wks, BBW: rare delayed anaphylaxis, MedGuide
LABAs: Long-Acting β2 Agonists
1. Salmeterol (Serevent Diskus) 1 inhalation bid Slow Onset- Take 30 min prior exercise 2. Formoterol (Foradil Aerolizer) Inhale 1 cap bid Quick Onset- Take 15 min prior exercise
CURES 1. Database for which prescriptions 2. Each pharmacy submits dispensing data for these drugs how frequently 3. Which pharmacists must be registered to access CURES 4. When should HCP review CURES history
1. Schedule 2, 3, 4 (NOT 5) 2. weekly 3. All CA Rph licensed 4. < 24 hour before dispensing first fill and once every 4 months at least
1. Cancelling/voiding Form 222 = supplier wants to void 2. Cancelling/voiding Form 222 = supplier wants to cancel 3. Lost/stolen Form 222
1. Supplier notifies purchaser in writing. Supplier draws a line through cancelled items on copies 1 and 2 and print VOID in the space where they would usually put the numbers of items shipped 2. Purchaser notifies supplier in writing. Supplier indicates cancellations on copies 1 and 2 by ... print CANCELLED ... 3. Purchaser re-orders with new Form 222. Serial # or lost form, date of loss, and statement that CS were not received must be recorded on the NEW Form 222. -Copy of this statement must be sent to supplier and copies 1 and 2 of the second order form -Purchaser files Copy 3 of the new and original lost or stolen form 222 together -If supplier subsequently receives the original order form, it is marked as "not accepted" and returned to the purchaser who files original copies 1 and 2 with original copy 3
Pharmacist Breaks
1. Up to 30min if no pharmacist in the pharmacy (without closing down the pharmacy and pharmacist does not have to stay in pharmacy area) 2. Ancillary staff may stay in pharmacy if pharmacist okays it and things are secure 3. Staff can only perform ancillary duties 4. Only refills that don't need counseling can be dispensed
The resale of drugs acquired at preferentially low prices is prohibited EXCEPT
1. When sold to a walk-in customer w/RX & those sales represent < 1% of the purchasing pharmacy's annual purchases 2. Emergency situation where no other sources are readily available in the community ***For profit must return exact drug & exact amount to non-profit pharmacy when drug comes in.
Form 222 - 3 copies 1. Copy 1 (brown) 2. Copy 2 (green) 3. Copy 3 (blue) -Max 10 items per order, only used for Schedule I and II drugs. Takes 1-7 business days. Order can be endorsed to another supplier, *Supplier must report transaction to DEA* by the end of the month drug in with the order was filled
1. Whoever is supplying the drug (supplier or pharmacy) 2. DEA 3. Whoever is requesting/receiving/purchasing the drug
Delivery of blood clotting agents: 1. non-emergency situations 2. emergency situation
1. Within 2 business days 2. Patient lives <100 miles of major metropolitan airport -> within 12 hours. Patient lives >100 miles of major metropolitan airport --> 1 day
Latanoprost 1. Brand 2. aux labels (2) 3. standard dosing
1. Xalatan 2. Protect from light, store unopened in refrigerator (opened at RT x 6mo) 3. 1 gtt into affected eye(s) QD
Oral Rx 1. C3-C5 2. C2 (2)
1. Yes 2. No, unless a) emergency - can fill enough to tide patient over until valid rx can be received. OR b) Pt is a resident of LSNF, intermediate care, home health agency, hospice.
1. Oral prescriptions for CS 3, 4, 5 2. Oral prescriptions for CS 2 3. Faxed prescriptions for 3, 4, 5 4. Faxed prescriptions for CS 2
1. Yes if RPh reduces Rx to writing on pharmacy's paper prescription form 2. Only allowed in two situations: A. emergency situation B. pt is resident of skilled nursing facility, hospice, etc 3. Yes, if prescriber manually signs the fax before sending it to the pharmacy -prescriber should use regular Rxform to write (since security form has "VOID" when faxed) 4. No, cannot dispense drug to the pt until pt hands in paper copy -Only exception is when pt is resident of skilled nursing facility, hospice, etc
Out of state CS prescriptions 1. C 2, 3, 4, 5 mail order 2. C 3, 4, 5 3. C 2
1. Yes, can be filled and delivered to patient by a CA pharmacy 2. Yes, can dispense prescriptions directly to patient 3. No, canNOT dispense Rx directly to the patient
Faxed Rx 1. C3-C5 2. C2 (2)
1. Yes, prescriber's signature has to be on original 2. No, except: -prescriber can fax over to give heads up, but pt needs to bring in original before dispensing -terminally ill
CS inventory counts 1. C1-C2 2. C3-C5 with 1,000 units or less 3. C3-C5 with > 1,000 units
1. exact count 2. estimated count 3. exact count
Actiq 1. generic 2. indication 3. dose
1. fentanyl lollipop 2. breakthrough cancer pain in patients *16 and older* 3. 200mcg lozenge - 4/day max
Central Hospital Packaging 1. Specialty license can only be given if 2. Any unit dose medications produced must be ___ 3. Label for each unit dose med must include: date prepared, BUD (3A), name of drug, quantity, special storage or handling, lot/control # (3B), name of centralized hospital packaging pharmacy
1. hospitals under common ownership and located within a 75 mile radius 2. Barcoded 3A: According to USP, BUD for unit dose med must either be 1 year from date repackaged or exp date on manufacturer's container 3B: Pharmacist must be able to retrieve with lot/control number: components used in the drug, exp date of each drug components, NDC numbers
2 ways controls may be disposed?
1. inventory form (DEA Form 41) mailed to designated disposal site within the state 2. manufacturer or wholesaler
"Red Flags" for controlled substance prescriptions
1. irregularities on the rx itself 2. pt has nervous demeanor 3. age of pt (youthful pts seeking chronic pain meds) 4. payments made only in cash 5. early refills 6. unusually large quantities 7. same combinations of drugs prescribed for multiple patients from the same prescriber 8. long distances traveled from patient's home to the prescriber's office or pharmacy 9. written outside the prescriber's specialty 10. written with no logical connection to diagnosis or pretreatment 11. not having adequate identification upon RPh request
Storage of drugs 1. Controlled drugs 2. Investigational New Drugs 3. Repackaged or Resold drugs 4. Recalled drugs 5. Expired drugs 6. Drug samples
1. locked cabinet or dispersed throughout the other drug stock (on shelves) 2. separate form other drug stock 3. separate from other drug stock, assigned BUD 4. Separate from other drug stock, Class I, II, III 5. Separate from other drug stock 6. Same, not allowed in retail pharmacies
Patient Assistance Programs 1. For who 2. Who provides 3. Online directory
1. low-income, uninsured patients get free or low-cost brand name drugs 2. Manufacturers 3. rxassist.org --> each has specific requirements
Auxiliary labels required by law
1. may cause drowsiness 2. may affect vision 3. when combined with alcohol, may cause drowsiness or serious side effect 4. multiple drug medication package
Nicotine replacement therapy 1. Requirements for pharmacist to furnish 2. When cannot furnish and refer to HCP 3. When can furnish with caution and refer to HCP 4. Avoid if nasal allergy; avoid if TMJ
1. minimum of 2 hours of CE and completes ongoing CE focused on smoking cessation therapy every 2 years 2. Pregnancy 3. MI in past 2 weeks, hx of heart palpitations, arrhythmia, chest pain/angina 4. nasal spray, gum
Cytotec 1. generic 2. SE
1. misoprostol 2. Diarrhea
Drugs *compounded* into unit dose containers that are too small for full label compliance, can have: (4)
1. name of active ingredients 2. Concentration of strength/vol/wt 3. Pharmacy reference lot number 4. exp date
REMS Programs 1. clozapine (Clozaril - antipsychotic) 2. ER/LA opioids 3. Saxenda (liraglutide, 1x injection for wt loss) 4. Addyi (flibanserin) - low libido in women
1. neutropenia, monitor ANC 2. high abuse potential, life-threatening respiratory depression. Med guide reqd, prescriber must complete approved CE, counsel pts 3. risk of medullary thyroid cancer, pancreatitis 4. risk of HOTN and syncope if used with alcohol
Number of refills allowed. 1. Non-controlled 2. C5 3. C3-C4 4. C2
1. no limit, can dispense up to 1 year from issue date 2. No limit of number of refills, up to 6 months from issue date 3. 5 refills in 6 months and all refills combined cannot exceed 4 months (120 day supply). Original fill is NOT a refill, not induced in the 120 day supply. 4. NO refills allowed. No emergency refills allowed. Can have emergency verbal order obtained from MD - written order must be sent within 7 days.
Emergency refills --> only if failure to refill might cause patient harm & prescriber not available to refill --> must notify prescriber within a reasonable amount of time 1. Non-CS 2. Schedule 3-5 3. Schedule 2 + what is needed
1. no specific quantity limit; professional judgement 2. only reasonable amount to cover emergency period. Pharmacist must note on the reverse side of the prescription the 1) date and quantity of the refill, 2) prescriber was not available, and 3) reason to refill prescription without prescriber's authorization 3. Not possible bc Schedule 2 does not have refill. Needs emergency verbal order (though written/electronic rx preferred) -Prescriber must provide an original prescription by the 7th day following the fill date. Must have "authorization for emergency dispensing" on oral prescription and attach original Rx to emergency rx -If doesn't receive, must report to CA Bureau of Narcotic Enforcement within 144 hours and DEA
Prescriptions 1. Agents can transmit which prescriptions 2. What can prescribers self-prescribe 3. What can prescribers prescribe to family members 4. Deceased prescribers 5. Rx from other states --> different for CS 6. Rx from other countries 7. Keep Rx for how long
1. non-controlled, schedule 3-5 (NOT 2) 2. non-CS 3. non-CS and controlled substances as long as there is a valid physician/pt relationship, legitimate medical purpose, good faith exam 4. Rx valid until all refills are gone and not expired. -If another doc takes over decreased doc's practice, request new prescription for refill 5. Can fill if prescriber has a license equivalent to required CA prescriber. Rph verify prescriber's license and determine if he/she is authorized 6. Only for US territories (Puerto Rico, Virgin Islands, Guam, American Samoa) 7. 3 years
RPH can supervise (community setting): 1. # techs at one time 2. # pharmacy interns at one time 3. # pharmacies (if PIC) 4. # pharmacy tech trainee, and for how many hours? 5. # clerks 6. # techs in hospital
1. one, 2 for 2nd RPh 2. two 3. two (within 50 miles of each other) 4. one, 120 hours 5. unlimited 2. 2 per RPh
Medicare 1. 3 groups of people 2. Medicare Part D is the drug benefit and obtains drugs at ___ reimbursement rate 3. The 4 criteria Star Rating System
1. people 65+, <65 with disability, patients with ESRD 2. Medi-Cal 3. Annual CMR for patients in MTM programs; adherence to non-insulin DM meds, statins, and ACEI/ARB/aliskiren; appropriate use or avoidance of high risk medications in patients 65+; ensuring statin use in patients with DM age 40-75
Dispensing epinephrine auto injectors 1. Pharmacist can dispense to 2. Epi auto inj should be dispensed with ____ and labeled with
1. pre-hospital emergency medical care person, lay rescurer, authorized entity for first aid purposes 2. manufacturer's product information sheet -pt name, dose, use, exp date, designation "section 1797.197a responder" and "First Aid Purposes Only"
Section 503B of FDC Act - Outsourcing facilities; regulated by both FDA and State Board 1. What is it 2. Requirements to be an outsourcing facility 3. What can outsourcing facility not to (2)
1. preparing meds in bulk and without a Rx 2. Must be compounding sterile drugs for humans - cGMP compliance - licensed as an outsourcing facility by the FDA and CA BoP - subject to inspection by the FDA and CA BoP - Preparations must be made by or under the supervision of a licensed pharmacist - facility must meet certain labeling + drug reporting + AE requirements 3. Licensed as a sterile compounding pharmacy, cannot perform functions of a pharmacy (filling individual prescriptions, etc)
Combat Methamphetamine Epidemic Act 1. drugs involved (4) 2. limits (daily, monthly, mail, per transaction) 3. what must patient present? 4. exception 5. how long are records of sale kept?
1. pseudoephedrine, ephedrine, phenylpropanolamine (vet use), norpseudoephedrine (not available in US) Document sales, qty limits, keep behind the counter or in locked cabinet 2. Limits - 3.6gm/day - 9gm/30 days - 7.5gm/30 days if mail order - 3 boxes/transaction 3. Pt needs photo ID or passport 4. Not enforced w/ single dose packs (60mg in 2-30mg tabs) Pharmacies must self-certify to Attorney General of the US they are trained to sell these 5. Keep records for 2 years
DEA Forms 1. Form 224 2. Form 225 3. Form 363 4. Form 222 5. Form 106 6. Form 41
1. registration for: retail, hospital, clinic, practitioners 2. registration for: mfg, distributor, researchers, analytical laboratories, exporters 3. registration for narcotics treatment program 4. Ordering C1-C2 drugs 5. Reporting theft or significant loss of CS 6. Record of CS destroyed
HIPAA 1. "minimum necessary" information 2. Permissible to share PHI with: 3. Can patient request copy of their records
1. required for the job is what should be shared 2. Pt, other HCPs providing care to pt, treatment, payment, operations, other ppl when pt authorized, research, law 3. Yes and pts must be able to inspect their medical records within 5 business days of making a written request and receives copies within 15 business days
naloxone (Narcan) 1. MOA, use 2. onset/duratin naltrexone 3. use 4. onset/duration
1. reversed opioid OD (typically from heroin) 2. onset within mins, lasts 1 hour. 3. Used to block cravings for opioids and alcohol. Cannot treat OD! 4. longer onset, longer duration (1/2 day)
Ex of REMS 1. Thalidomide 2. isotentinoin 3. clozapine 4. Qsymia 5. Avinza, Butrans, Hysingla ER, Kadian... 6. Sexenda 7. Addyi
1. risk of severe birth defects 2. risk of severe birth defects - iPledge program 3. Clozaril - neutropenia 4. phentermine/topiramate - wt loss - birth defects 5. high risk abuse potential, CN depression 6. lirgluatide (Trajenta, anti-DM GLP-1) - medullary thyroid carcinoma 7. finbanserin - female sexual health - HOTN/syncopy with alcohol
CA End of Life option act 1. 2 drugs used, both Schedule 2
1. secobarbital (capsules), pentobarbital (solution). Should take an anti-emetic an hour before drug is taken
Correcting errors on a CS prescription 1. CS 3, 4, 5 2. CS 2 --> RPh cannot change 5
1. signed and dated by prescriber --> cannot be written in by the Rph 2. A. Issue date, B. Prescriber's name, C. Prescriber's signature, D. Patient's name, E. Drug's name -Other changes can be changed as long as Rph verifies the change with the prescriber first
1. Orange Book 2. *A*B = 3. *B*B =
1. substitution generic for brand and vice versa 2. generic *is* therapeutically equiv to brand 3. generic *is not* therapeutically equiv to brand
Reporting time period 1. Change of pharmacist address or name 2. Change of PIC 3. Changes in the pharmacy permit 4. Theft by or impairment of a licensee 5. Loss/theft of controlled drugs 6. Bankruptcy, insolvency, receivership
1. within 30 days 2. within 30 days 3. within 30 days 4. within 14 days 5. Report to DEA immediately (within 1 business day) Report to CA BOP within 30 days 6. Immediately
Ways C2s may be ordered or transferred
1. written on California Security Form Prescription filled within 6 months 2. oral or phoned-in c2 for emergency purpose 3. for terminally ill patients 4. by e-prescribing 5. DEA form 222 between pharmacies, to a prescriber's office, from wholesaler 6. for disposal purposes
1. Can RPh fill rx from out-of-state md? 2. Can RPh fill rx from out-of-country md? (4 "exceptions")
1. yes - if the prescriber has a license equivalent to that of a CA provider 1. no. Except: DC and US territories (Puerto Rico, Virgin Islands, Guam, American Samoa)
SABAs: Short-Acting β2 Agonists
1.Albuterol Levalbuterol (Xopenex HFA) Pirbuterol (Maxair Autohaler)
Must report AEs to BOP within...
12 hours
Non-Controlled Substance expiry in California
12 months
How long is the interim period for temporary PIC?
120 days
If unable to get a new PIC with 30 days of original PIC leaving, the board can provide an extension. How long is this extensinon?
120 days
Pharmacy Board consists of:
13 members - 11 appointed by governor, 2 appointed by committe of the Senate -7 of Governors pick must be RPh, 5 must be active practicing in atleast one of the practice settings -6 must be non-pharmacist members
BOP Board
13 members serving 1 or 2 4-year terms +/- executive officer who may or may not be a board member
how many members of the board ?
13 members, each of them serve 1 or 2 terms, each term is 4 years. The board elects a president, a vice president, and a treasurer. the board may appoint an executive officer, who may or may not be a board member.
Maintain records for: 13. Record documenting transfers or sales to other pharmacies, licensees and prescribers 14. Theft and loss reports of controlled substances (Form 106) 15. Pseudoephedrine, ephedrine, phenylpropanolamine, norpseudoephedrine sale logs 16. Patient medication profile (unless Rph feels pt will not come back to pharmacy) 17. Medication error/quality assurance reports
13. 3 years 14. 3 years 15. 2 years 16. 1 year from date when last prescription filled 17. 1 year
Time to notify board of any tampering with a collection bin
14 days
Time to notify board of any tampering, damage, theft of removed liner
14 days
Time to notify board of theft of deposited drugs
14 days
Within how many days must the CABOP be notified of any *termination of a licensed* individual based on theft, diversion, or self-‐use of dangerous drugs?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any *termination* based on chemical, mental, or physical impairment of a *licensed* individual to the extent it affects his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any video or documentary evidence demonstrating chemical, mental, or physical impairment of a *licensed* individual to the extent it affects his or her *ability* to practice?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any video or documentary evidence demonstrating theft, diversion, or self-‐use of dangerous drugs by a *licensed* individual?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any *admission* by a *licensed* individual of theft, diversion, or self-‐use of dangerous drugs?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any admission by a *licensed* individual of chemical, mental, or physical *impairment* affecting his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any admission by a licensed individual of theft, diversion, or self-‐use of dangerous drugs?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any termination of a licensed individual based on theft, diversion, or self-‐use of dangerous drugs?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the SBoP be notified of any video or documentary evidence demonstrating theft, diversion, or self-‐use of dangerous drugs by a licensed individual?
14 days (B&PC § 4104[c])
If no security prescription for Schedule II drug is sent by prescriber to the pharmacy following an emergency oral prescription, what is the time period the pharmacy must notify the DEA?
144 hours (H&SC § 11167[d])
How many days does pharmacy have to appoint new PIC if board disapproved original candidate
15 days
How many pharmacist intern hours are required?
1500 hours
Pharmacist intern hours requirement
1500 hours
Pharmacist-intern hour requirement
1500 hours
What is the pharmacy intern hours requirement?
1500 hrs (B&PC § 4200)
Requirements for pharmacy license
18 yo, graduated college of pharmacy or dept of pharmacy of a university. If foreign then certified by FPGEC. Completed 150 units of collegiate study in the US or equivalent in foreign country. No less than 90 units must have been a resident of US. Complete 1500 hours of pharmacy practice. Passed written & practical exam given by board. Proof of qualifications supplie to board. Paid fees
Dextromethorphan (Delsym) Sales
18+YO with photo ID or looks at least 25+YO
Temporary permit for pharmacy if there's a change in owner is good for how long?
180 days
Temporary permit issued upon transfer of ownership
180 days
What is the maximum beyond-use-date (BUD) for any compounded prescription?
180 days (CCR § 1735.2[h])
What is the maximum beyond-‐use-‐date (BUD) for any compounded prescription?
180 days (CCR § 1735.2[h])
Maximum BUD
180 days (Or shorter depending on the ingredients)
Pharmacist: Intern Pharmacist: Tech Pharmacist: Clerk Ratios
1:2 1:1 If the first pharmacist on duty. 1:2 if another pharmacist hops on. 1:X as many a the Pharmacist wants.
Prescription container labeling requirements 1. Drug name: A. If brand is dispensed B. If generic name is dispensed 2. 2-12 -Expiration date can be one of 3 choices
1A: brand name; manufacturer's name is not required 1B: generic name, statement "generic for [insert brand name equivalent]," and the generic drug manufacturer 2. Drug strength 3. Drug quantity 4. Directions for use 5. name of patient or patients 6. name of prescriber 7. Date of issue (date the prescription was written) 8. Name and address of pharmacy 9. Rx number 10. Expiration date (either exp on manufacturer's container OR 1 year from date of the drug is dispensed OR BUD) 11. Condition or purpose of drug (if written on Rx) 12. Physical description of the drug (including *color, shape, imprint*)
Celexa(40 mg/d QT risk)=Lexapro(10-20mg/d)=Zoloft(50-200mg geriatrics)=Prozac(20mg QAM d/t insomnia, high DIs, easy d/c long t1/2); Sarafem for premenstrual dysphoric disorder=Paxil (20mg HS d/t sedation, high DI, ^wt gain, taper short t1/2) Pexeva, Brisdelle (treat depression, anxiety disorders, obsessive-compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD))
1st SSRI: Citalopram=Escitalopram=Sertraline=Fluoxetine=Paroxetine: 1. 30% sexual SE. 2. Wt gain 3 kg 3. QAM if insomnia, QPM if sedation; low anticholinergic SE 4. MedGuide and preg-C-D for all antidepressants
Stelazine=Navane=Prolixin=Compazine, compro=Haldol>>Loxitane>>Thorazine=Mellari
1st gen/typical: Trifluoperazine=Thiothixene=Fluphenazine=Prochlorperazine (nausea and vomiting, anxiety, schizophrenia.)=haloperidol>>Loxapine>>Chlorpromazine=Thioridazine(worst QT prolongation) 1. high>>low potency 2. SE: EPS, orthostasis, QT prolongation, anticholinergic, skin rxs
Fortamet E.R., Glucophage XR, Glumetza E.R./Janumet
1st line: *Metformin/+Sitagliptin* 1. high efficacy 2. low risk of hypoglycemia (500-1000mg QDCC or BIDCC. Max 2500 mg/d) 3. SE: GI, metallic taste, decrease folate and Vit B12(neuropathy) BBW: lactic acidosis> avoid alcohol and iodinated contrast dyes 4. CL if SrCl>=1.5 men, >=1.4 women; GFR<60, okay for preg 5. insulin sensitizers; decrease both basal and postprandial G
Precose=Glyset
1st: *Acarbose*(Monitor LFTs q3mo. 50-100 TID)=Miglitol*(renal): 1. alpha-glucosidase inhibitor>delay G absorp and decrease postprandial>take with the 1st bite of meal. No meal no drug 2. SE: 80% cause GI problems, gas/diarrhea/regulate lipids 3. Pro: CV benefits
Keflex(oral); Duricef(oral); Ancef, kefzol(IV/IM)
1st: Cephalexin*; cefadroxil*; cefazolin: renal toxicity, C. diff; * cross sensitivity with penicillin, Gram+
Januvia=Onglyza=Tradjenta
1st: DPP-4 inhibitors/Gliptins: *Sitagliptin(renal)=Saxagliptin(renal)=linagliptin(no renal)*: 1. analogs>>insulin secretagogues, low risk of hypoglycemia 2. SE: pancreatitis, ^risk of infection, decrease BP and improve TG level 3. Monitor renal function. Onglyza>risk of HF
Produce records stored off-site within...
2 business days
What is the period of time prescription records must be produced from an off-‐site storage facility when requested?
2 business days (CCR § 1707)
How quickly must a pharmacy conduct an investigation once a medication error is discovered?
2 business days (CCR § 1711[d])
Pharmacists who participate in nicotine replacement program must have how many C.E. hours?
2 hours.
Max terms a BoP may serve?
2 terms
How long are California intern licenses valid for to graduates or out-of-state pharmacists?
2 years
How long must a pharmacy keep records of pseudoephedrine sales logs?
2 years
How long to keep Sudafed (etc) sales
2 years
pseudophenadrine, ephedrine, phenylpropanolamine, and norpseudoephedrine sale logs
2 years
How long should DEA form 222 order records be kept
2 yrs
How often is a controlled substance inventory taken?
2 yrs (21 CFR § 1304.11[b])
Controlled Cold Temperature definition
2.2 degrees to 7.7 degrees centigrade (36-46 degrees Fahrenheit)
Advanced Practice Pharmacist (APh) Criteria
2/3 must be satisfied 1. Earn certificate in relevant area of practice (amcare, crit care, onco, etc) 2. Complete postgrad residency 3. Have provided clinical services to pts for 1 year (>1500hrs) under CPA or protocol with physician, APh, pharmacist practicing CDTM, or within a health system
Clozaril/FazaClo ODT/Versacloz suspension=Zyprexa/Zydis ODT/Relprevv(q2-4 wks, IM)=Abilify/Maintena(q4wks IM)/Aristada(q6wks IM)=Geodon=Risperdal/M-tabs ODT/Risperdal Consta=>Invega OROS/sustenna(q4wks)/Trinza(q3ms)=Saphris SL=Seroquel; Resulti; Vraylar
2nd gen Atypical: *Clozapine*(1. highest metabolic SE, but most effective>>reserved option 2. BBW: agranulocytosis>>WBC+ANC 3. REMS: Clozaril registry 4. DDI with BDZ)*=Olanzapine*(related to clozapine+fluoxetine=symbyax)*=Aripiprazole*(1. neutral metabolic 2. least sedative but activating)*=Ziprasidone*(1. neutral metabolic 2. QT, w/f, DRESS)*=Risperidone*(1. EPS, ^prolactin 2. Refri injection with special needle)=>metabolite: *paliperidone*(OROS tab ghost may be seen in stool)*=Asenapine*(least wt, sedating, anticholinergic, but high QT)*=Quetiapine* (Very sedating, Metab issue, no driving+no food for XR or light meal(300kcal)+IR is not with or without food, only one approved for bipolar) : Neuroleptic Malignant Syndrome is a life-threatening rx to APS; preg-C; *Brexpiprazole*(t1/2 91hrs; MDD); *Cariprazine*(t1/2 2-5days): BBW: elderly patients with dementia treated with antipsychotics are at increased risk of death; suicidal thinking/behavior
Cymbalta=Effexor=Pristiq
2nd line SNRIs: Duloxetine DR=Venlafaxine(QAM)=Desvenlafaxine(QAM): 1. 30% N/V 2. ^BP 3. cymbalta for neuropathic pain
1. Glucotrol/Metaglip=Diabeta,Micronase,Glynase/Glucovance=Amaryl 2. Prandin=Starlix
2nd line Sulfonylureas: *Glipizide/+met*(max 40mg/d)*=Glyburide/+met*(max 20mg/d)*=Glimepiride*(max 8mg/d): 1. high efficacy 2. moderate risk of hypoglycemia, skip if no meal 3. Sulfa allergy, wt gain Meglitinides: *Repaglinide*(max2mg)*=Nateglinide*(Max 120mg) 1. similar as SFUs, alternative for renal&elderly but no comb 2. TIDAC
Actos=Avandia
2nd line Thiazolidinediones: *Pioglitazone* (regulates lipids, respir. infections, 45mg/d) *=Rosiglitazone*(8mg/d, stuffy nose, anemia, ^ cholesterol, high efficacy, low risk of hypogly but wt gain from fluid retention, con: HF, bladder cancer and fracture, CL if liver function)
Mefoxin; Ceftin/Zinacef; Cefzil; Ceclor
2nd: Cefoxitin; Cefuroxime; Cefprozil*; cefaclor*: Gram +/-, renal toxicity, C. diff, preg B, *cross sensitivity with penicillin
Optometrists can prescribe codeine / hydrocodone-containing products with a max _______ day supply
3 day supply and must be registered with the DEA and have a DEA number + be certified by their board.
ALL drug acquisition or disposition must be maintained for?
3 years
DEA Form 222 order records
3 years
DEA forms 222, power of attorney forms
3 years
How long do all rx records need to be kept?
3 years
How long should records for dispensing Epipen to schools be maintained for?
3 years
How long should records of dangerous drugs/devices to approved emergency service providers be maintained for?
3 years
How long to keep CS inventory
3 years
How long to keep DEA 222, POA form
3 years
How long to keep biennial CS inventory
3 years
How long to keep community or clinic pharmacy rx
3 years
How long to keep hospital pharmacy chart order records for nonCS drugs
3 years
How long to keep purchase invoices for all rx
3 years
How long to keep record documenting return of drugs to wholesaler or manufacturer
3 years
How long to keep record documenting transfers or sales to other pharmacies, licensees, prescribers
3 years
How long to keep self-assessment forms
3 years
How long to keep theft and loss reports of CS (DEA 106)
3 years
If RPh doesn't renew their license, after how long are they unable to pay a fine and renew (reqd to re-take licensing exams to re-instate license)?
3 years
What is the time limit requirements in the keeping of pharmacy records for *Controlled substance inventory records?
3 years
What is the time limit requirements in the keeping of pharmacy records for *DEA Form 222 order records
3 years
What is the time limit requirements in the keeping of pharmacy records for *Self Asssessment of Pharmacy records*?
3 years
What is the time limit requirements in the keeping of pharmacy records for *clinic pharmacy prescription records*?
3 years
What is the time limit requirements in the keeping of pharmacy records for *community pharmacy prescription records*?
3 years
What is the time limit requirements in the keeping of pharmacy records for *pharmacy technician compliance records*?
3 years
biennial controlled substance inventory
3 years
community or clinical pharmacy prescriptions
3 years
controlled substance inventory
3 years
each self-assessment form will be kept for ?
3 years
hospital pharmacy chart order records for non controlled drugs
3 years
how long the prescription to be keep?
3 years
purchase invoices for all prescriptions drugs
3 years
record documenting return of drugs to wholesaler or manufacturer
3 years
record documenting transfer or sales to other pharmacies, licenses and prescribes
3 years
self-assessment forms
3 years
theft and loss reports of controlled substances (DEA form 106)
3 years
How long to keep e-rx records
3 years *Record keeping system must be able to sort by prescriber name, patient name, drug dispensed, date filled
How long must community pharmacy prescription records be kept on file for inspection?
3 years (B&PC § 4081[a])
How long must hospital pharmacy order records be kept on file for inspection?
3 years (B&PC § 4081[a]) 7 years for controls
How long must the pharmacy Self-‐Assessment forms be kept on file for inspection?
3 years (CCR § 1715)
How long must controlled substance inventory records be kept on file for inspection?
3 years (CCR § 1718)
How long can an expired RPh license go before it can no longer be renewed?
3 years after expiration
prescription must be kept for /
3 years total, however, rx for non controlled substances must be kept at the pharmacy for at least 1 year. after that the pharmacy can choose to store the prescriptions off site for another 2 years.
How many days does pharmacy have to inform board that it will furnish meds to a master/first officer of a vessel
30 days
If a partial fill is requested by the patient or provider that wrote the rx of a C2, the remaining portion of the prescription must be filled within what time frame?
30 days
Report change of PIC by
30 days
Report change of pharmacist address of name by
30 days
Report changes in pharmacy permit by
30 days
Time to notify board of establishment of drug take back service
30 days
Within how many days must the board be notified by the PIC if a licensed employee of the pharmacy is involved in the theft, diversion, or self-use of a drug or exhibits behavior representing an impairment that affects that person ability to practice
30 days
Within how many days must the board be notified of a change of address or name
30 days
Within how many days must the board be notified of a change of pharmacy ownership
30 days
Within how many days must the board be notified of a change of the pharmacist-in-charge
30 days
Within how many days must the board be notified regarding any change in pharmacy permit
30 days
Within how many days must the BOP be notified of *controlled substance loss*? Any loss due to employee theft?
30 days 14 days
Within how many days must the SBoP be notified of a pharmacist change of name or address?
30 days (B&PC § 4100)
When a pharmacy contracts to compound a drug for parenteral therapy, the contractual arrangement is reported to the board within how many days of commencing compounding?
30 days (B&PC § 4123)
Within how many days must the SBoP be notified of a change of PIC?
30 days (B&PC §§ 4101, 4113)
Within how many days must the SBoP be notified of a change of pharmacy ownership?
30 days (CCR § 1709)
Within how many days must the SBoP be notified of controlled substance loss (theft)?
30 days (CCR § 1715.6)
Within how many days must the board be notified of drug loss (by destruction or pilferage)
30 days (if controlled substance DEA notified immediately)
A new PIC must complete an inventory within...
30 days of becoming PIC.
"What is the CE hours requirement for the 2nd and all subsequent pharmacist license renewals?"
30 hours (B&PC § 4231)
What is the CE hours requirement for the 2nd and all subsequent pharmacist license renewals?
30 hours (B&PC § 4231)
What is the CE hour requirements for Pharmacists?
30 hours every 2 year license renewal period
Continuing Education Hour Requirement
30 hours for each 2 yr license renewal period
What is the maximum amount of time a pharmacist may leave the pharmacy with other non-‐pharmacist personnel present?
30 minutes (CCR § 1714.1)
What is the maximum amount of time a pharmacist may leave the pharmacy with other non‐pharmacist personnel present?
30 minutes (CCR § 1714.1)
How many hypodermic needles can someone get from a Pharm.D. or an M.D. without an RX?
30 or less assuming the patient is 18 years or older.
Continuing education hour requirement
32 hour for each 2 yrs license renewal period
Pamelor=Norpramin=Asendin; Elavil(off-label for pain and migraines)=Tofranil=Silenor,zonalon, prudoxin (depression, anxiety, and sleep disorders in its oral form)=Anafranil(OCD)
3rd line antidepressant TCAs: 2ary>*Nortriptyline=Desipramine=Amoxapine*; 3rd>*Amitriptyline=Imipramine=Doxepin=Clomipramine*: 1. inhibit NE, 5HT reuptake, block ACh and histamine 2. SE: cardiotoxic, anticholinergic, vivid dreams, wt gain, sedation, falls, hypotension, lethal overdose 1-2g
Omnicef; suprax; fortaz; rocephin(hepatic); ceforan(active metabolite)
3rd: Cefdinir; Cefixime; Ceftazidime; Ceftriaxone; Cefotaxime: Streptococcal/PSA; no cross sensitivity with penicillins
How many times can an applicant fail the licensure exam before being required to take extra units of education?
4 times
How long to keep CE records
4 years
What is the time limit requirements in the keeping of pharmacy records for *CE course completion?
4 years
certificate of completion for continuing education
4 years
How long should certificates of CE course completion be kept
4 yrs from date of course completion
If mobile pharmacy is started after main pharmacy is destroyed/damaged, when must the mobile pharmacy halt business after original pharmacy is restored
48 hours after restoration
An order in the hospital can be entered by staff other than the provider. But the provider must sign off in...
48 hours.
Sale of CS to other pharmacies/prescribers cannot exceed ___% of total number of CS dosage units dispensed per calendar year.
5% -otherwise will need to obtain wholesaler registration from DEA and BOP.
How long is a c2 rx good for?
6 months
How long is a c2 rx valid?
6 months
Within how many days must a valid prescription for a controlled substance drug be filled?
6 months (H&SC §§ 11164[a][1], 11120[e])
Expiration data for any compounded prescription
6 months or less (if any ingredient expires before 6 mo)
How long to keep pt acknowledgement of HIPAA
6 years
Transaction info, history, statement for most rx drugs under Drug Supply Chain Security Act
6 years
transaction information, history, and statement for most prescription drugs as required under the drug supply chain security act
6 years
HIPPA Acknowledgement must be kept for...
6 years.
A partial fill of a C2 drug is allowed for a LTCF resident --> the remaining portion of the prescription must be filled within what time frame?
60 days
Any other licenses issued by the Board may be canceled by the Board if the license is not renewed within ____ after its expiration.
60 days
How long is a "terminally ill" C2 rx good for?
60 days
A partial fill of a C2 drug is allowed for a terminally ill patient --> the remaining portion of the prescription must be filled within what time frame?
60 days - must note "terminally ill" on rx
Hospital Pharmacy Chart orders for Controlled Substances must be kept for...
7 Years.
How long does a prescriber have to furnish an emergency fill c2 hardcopy rx on the security form to the pharmacy?
7 days
How long does a prescriber have to send the Schedule II security prescription to the pharmacy following an emergency oral prescription?
7 days (H&SC § 11167[d])
How many of the BoP members must be pharmacist?
7 total 5 must be actively practicing
How long to keep hospital pharmacy chart order records for CS
7 years
What is the time limit requirements in the keeping of pharmacy records for *hospital pharmacy prescription records*?
7 years
When must a CII order be completed if a partial was given
72 hours
Within how many hours must the SBoP be notified of a reasonable cause to believe that a dangerous drug or dangerous device in, or having been in, the possession of a pharmacy is counterfeit or the subject of a *fraudulent transaction* ?
72 hours (B&PC § 4107.5)
Within how many hours must the SBoP be notified of a reasonable cause to believe that a dangerous drug or dangerous device in, or having been in, the possession of a pharmacy is counterfeit or the subject of a fraudulent transaction ?
72 hours (B&PC § 4107.5)
If unable to supply the full quantity, a pharmacist may partially fills a Schedule II prescription and the remaining portion of the prescription must be filled within what time frame?
72 hours(21 CFR § 1306.13[a])
Centralized Hospital Pharmacy Packaging radius?
75
Methylnaltrexone (Relistor) (Rx)
8-12mcg SC every other day PRN. ONLY for use with OPIOIDS who have failed docusate + senna or bisacodyl
Point to Your Language Sign
8x11 print paper signage required in pharmacy
Monthly limit of ephedrine-like products
9 grams
If a shift is 5 or more hours long, pharmacists are entitled to...
A 30 minute duty-free break. Refills w/o counseling can be released when the pharmacist is on break. However the intern cannot take oral orders, or counsel new patients when they're not present.
Hospital, clinic, practitioner, teaching institution, pharmacy DEA...
A B F G
how many pharmacy can PIC supervise ?
A PIC can supervise up to 2 pharmacies as long as they are within 50 driving miles of each other. any change of PIC is reported to the board in writing within 30 days.
Electronic transmission
A pharmacy or hospital may receive electronic data transmission of prescriptions or computer entry prescriptions for controlled substances: II, III, IV, V & nonscheduled
Tech Check Tech
A tech (instead of RPh) with special training checks another tech's work (filling/replenishing unit dose, floor stock, ward stock) *Hospital setting only that has ongoing clin pharm program and pharmacists located in patient care areas. Pharmacy must have description of clin program before starting TCT. **RPh must still check compunded/repackaged drugs before tech uses it to fill
1. Written prescriptions for Medi-Cal outpatient drugs security (OTC, non-CS, and CS drugs) to be reimbursable by federal government (3 tamper proof requirements) 2. Written prescription for CS outpatient drugs security -Can be used for Medi-Cal Rx -2 exceptions for CS drug
A1. Prevent unauthorized copying of completed or blank Rx (Word "void" when photocopied, watermarks, etc) B2. Prevent erasure or modification of info (quantity check off boxes, refill check off boxes, "Rx is void if more than ___Rx on paper") B3. Prevent use of counterfeit Rx (each Rx serially numbered, certain text or images are printed in thermochromic ink) 2. Exceeds Medi-Cal Rx, used for CS 2-5 (*except terminally ill or emergency use*) -Includes checkbox for prescriber name, *preprinted* prescriber information, description of security feature on form, chemical void protection, date of issue (of form), etc -Terminally ill pt rx can be on plain Rx form with "11159.2 exemption" on it
Depakene/Stavzor=Depakote=Zarontin=Klonopin=Keppra=Zonegra
Absence petit mal: *Valproate or Valproic acid=Divalproex**=Ethosuximide*(Blood dyscrasias)*=>Clonazepam*(C-IV. Max 20mg/d, cognitive impair) *=>Levetiracetam**=>Zonisamide*
1. *Benoxyl/Benzac/Clearasil*+erythromycin=*benzamycin*(refrigerator, within 3 months); +clindamycin=*Acanya*(within 10 weeks)*/BenzaClin*(RT within months)*/Duac*(within 60 days)*/Neuac*; +hydrocortison-*vanoxide* 2. Retin-A/Avita, Differin>>+BPO=epiduo, Tazorac, Aczone 3. Accutane/Claravis/Amnesteem/Sotret
Acne: 1. *Benzoyl peroxide*(most effective OTC) 2. Topical retinoids: *Tretinoin Cream* *Adapalene* *Tazarotene**Dapsone gel* SE: irritation, limit sun exposure, avoid in pregnancy 3. *Oral Isotretinoin*: severe acne, full effect in 3-5 mo, SE: dryness, MedGuide, BBW: preg X>2 forms of birth control+informed consent+iPLEDGE program for all +cause blurred vision and photosensitivity; avoid VitA, tetracyclines,steroids, POP, St. John's wort; swallow whole or puncture and srinkle on applesauce or ice cream; arthralgias; psychiatric issue; transient chestpain and hearing loss
Master compounding formula
Active ingredients. Inactive ingredients. Process/procedures used. QA reviews at each step. Post-compounding process or procedures if any. Exp date requirements (not to exceed 6 mo or shortest exp date of any component of compounded drug)
Tdap
Adacel, Boostrix
Differin>>+BPO=epiduo; +clindamycin=ziana topical retinoid
Adapalene
Flibanserin>>risk of hypotension and syncope d/t interaction with alcohol>> REMS
Addyi (treat decreased sexual desire in some women)
Adenocard
Adenosine: 6mg IV push antiarrthymics
Emergency filling of CIIs
After oral authorization, prescriber must provide an original prescription by the 7th day following the fill date. If not, pharmacist must report to Ca Bureau of Narcotic Enforcement within 144 hrs
AlternaGel=Amphojel; Phoslo=Phoslyra, Tums; Fosrenol=Renvela,Renagel
Al hydroxide(30ml TIDCC); Ca cetate=Ca carbonate; Al/Ca free: Lanthamun carbonate(chew thoroughly)=Sevelamer(MedGuide)
Tekturna; Valturna
Aliskiren+HCTZ; Aliskiren+Valsartan: direct renin inhibitor; w/o f but be consistent; high fat meal decrease absorb; metabolic acidosis
Treanda=Busulfex inj/Myleran tab=Thioplex=BiCNU/Gliadel Wafer=Leukeran=Cytoxan/Neosar/Procytox=Ifex=CeeNU
Alkylators: *Bendamustine*=*Busulfan*=*Thiotepa*=*Carmustine*=*Chlorambucil*=*Cyclophosphamide*=*Ifosfamide*=*Iomustine*: *Mesna* treat cytoxan and ifex hemorrhagic cystitis
Maintained for at least: 7. Hospital pharmacy chart order records for non-CS drugs 8. Controlled substance inventory 9. Forms 222, power of attorney forms 10. Purchase invoices for all prescription drugs 11. Self assessment form (PIC fills out --> keep at pharmacy) 12. Record documenting return of drugs to wholesaler or manufacturer
All 3 years -DEA forms -Rx acquisition (invoices, supplies) -RX disposition (dispensing, etc) -Self-assessment forms
Prescribing Controls
All HCPs that prescribe controlled substances MUST register with DEA (DEA 224)
HIPAA
All HCPs who have access to PHI must have documented HIPAA training
Security prescription form
All orders for controlled substance including CV must be ordered by MD on this form
Reyataz(with food)
Atazanavir(PI)
Evotaz**1. atazanavir take with food 2. PI birth control less effective
Atazanavir(PI)+cobicistat(PI)
Tenoretic
Atenolol/Chlorthalidone treat high blood pressure, reducing the risk of stroke and heart attack
Check the validity of a DEA number
B T 6 8 3 5 7 5 2 B= presriber code (A B F G) T= first letter of prescribers last name. Step 1: add 1st 3rd, and fifth Step 2: add 2nd, 4th, and 6th. Step 3: Multiple even numbers in step 2 by 2 Step 4, add the summations. the last digit of this answer should be the last number of the DEA number.
RPh can perform ___tests which are waived under CLIA (no CDPH registration reqd) (3)
BG A1C Cholesterol
Centralized Hospital Packaging
BOP created special license for hospital pharmacy to perform centralized packaging for pharmacy's hospital and one or more general acute care hospitals under common ownership and w/in 75mi radius
Cardura=Hytrin=Minipress=Flomax=Uroxatral=Rapaflo 2. Avodart/Jalyn=Proscar/propecia
BPH: 1. a-1 blockers: *Doxazosin*(8mg hs>16mg)*=Terazosin*(10mghs>20mg)*=Prazosin*(5mg BID-TID)*=Tamsulosin*(0.4mg QD 30min after the same meal)*=Alfuzosin*(10mg QD with the same meal QD)*=Silodosin*(8mg QD w/f): 1st-line for BPH, 2-3rd line for HTN; syncope d/t orthostatic HTN 2. 5a-reductase inhibitors: *Dutasteride/+Tamsulosin=Finasteride*(Propecia 1mg QD for male pattern baldness) SE: sexual(decreased libido/semen, impotence), risk of prostate cancer; preg-X; 3. Herbals: Saw Palmetto
Beyond Use Dating for Sterile compounds using non-sterile ingredients
BUD cannot exceed: - 24 hours at controlled room temperature - 3 days at controlled cold temperature - 45 days at controlled freezer temperatures
Beyond Use Dating for Sterile compounds for multiple patients or one patient on multiple occasions
BUD cannot exceed: - 30 hours at controlled room temperature - 9 days at controlled cold temperature - 45 days at controlled freezer temperatures
Beyond Use Dating for Sterile compounds when involving complex aseptic manipulations
BUD cannot exceed: - 30 hours at controlled room temperature - 9 days at controlled cold temperature - 45 days at controlled freezer temperatures
Beyond Use Dating for Sterile compounds using only sterile ingredients
BUD cannot exceed: - 48 hours at controlled room temperatures - 14 days at controlled cold temperatures - 60 days at controlled freezer temperatures
how to choose a beyond use date ? low risk
BUD room temp: longer than other because it has low risk 48 hours max bue fridge temp 14 days longer as well BUD freezer temp 45 days longest is 45 days
Xanax=Ativan=Serax=Restoril=Halcion=Versed; Valium=Klonopin=Tranxene=Librium=Dalmane
BZDs C-IV : short-acting: *Alprazolam=Lorazepam*(DOC status epilepticus)*=Oxazepam*(alcohol withdrawal)*=Temazepam=Triazolam=Midazolam*(anesthesia); long-acting *Diazepam*(DOC status epilepticus)*=Clonazepam=Clorazepate=Chlordiazepoxide*(DOC epilepticus)*=Flurazepam*: 1. short acting, 1st line for s/sx reilef and 2nd line for insomnia and anxiety; 2. *Flumazenil(Romazicon)* 0.2mg IV>antidote BDZ overdose 3. Preg-D 4. LOT safer in elderly/liver disfx 5. Ativan: non PVC+filter
Take with plenty of water
Bactrim Bisphosphonates Azulfidine (+ food)
Do not refrigerate
Bactrim Lovenox Lasix Avelox Nexium Neosynephrine (phenylephrine) Dilantin Flagyl Ofirmev Precedex Hydralazine (BLLANND FOPH)
May make birth control less effective
Barbiturates Bosentan Rifampin Rifapentine Ampicillin Anticonvulsants Tetracycline St. Johns wort HIV drugs Griseofulvin (BBRRAATS HG)
*Aspirin/+Dipyridamole/+omeprazole*(preg C/D, overdose: tinnitus) *Naproxen/+esomeprazole*(BID, OTC 220mg>Rx250-550mg) *Indomethacin*(for gout, avoid in psych condition) *Piroxicam*(most GI>w PPI and misprostol) *Ketorolac* (IV/IM/PO, max 120mg/d, SE: bleeding, acute renal and liver failure, anaphylactic shock) *APAP/+hydrocodone/+oxycodone/+codeine/+tramadol/+diphenhydramine*(DOC for pain in preg & use with warfarin, overdose liver damage>antidote: N-Acetylcysteine *Ibuprofen* (max 3200mg/d, children max 40mg/kg/d) *Diclofenac/+misoprostol*(CV risk) *Celecoxib*(highest CV risk, CL with sulfa allergy, Preg-C&D) *Meloxicam, Etodolac, Diflunisal, Diclofenac* (COX-2)*Sunlindac*(less commonly used NSAID) *Oxaprozin*(similar to piroxicam) *Salsalate* (minimal platelet effects) *Ketoprofen*(High GI risk):
Bayer=ascriptin=bufferin=ecotrin/Aggrenox/Yosprala; Aleve=Naprosyn=Naprelan=Anaprox/Vimovo; Indocin; Feldene; Toradol; Tylenol(Ofirmev IV)/Vicodin=Norco=Lortab/Percocet=Endocet/Tylenol#2#3#5/Ultracet/Tylenol PM; Motrin=Advil(IV Caldolor); Cataflam=Voltaren XR/Arthrotec; Celebrex; Mobic; Lodine; Dolobid; Voltaren; Clinoril; Daypro; Disalcid; Orudis
When must the pharmacy (PIC) conduct a Self-‐Assessment? (CCR § 1715) (4)
Before *July 1st* every odd-number year or within 30 days of (1) a new permit;(2) change in PIC; (3) change in location
Mid level practitioner DEA
Begins with the letter M (Nurses, physicians assistant)
Nulojix/Organ rejection/CTLA-4
Belatacept (Immunosuppressive drug It can prevent the body from rejecting a transplanted kidney)
Lorcaserin **no pregnancy It reduces appetite by activating a type of serotonin receptor known as the 5-HT2C receptor in a region of the brain called the hypothalamus, which is known to control appetite
Belviq C-IV (weight-loss drug)
Tessalon
Benzonatate
Stimulant for weight loss: Regimex C-III
Benzphetamine (Didrex, Inapetyl)
Maintain x at least 3 yrs
Biennial controlled substances inventory Community or clinic pharmacy prescriptions Controlled substance inventory DEA forms 222, power of attorney forms Purchase invoices for all prescription drugs Self-assessment forms Record documenting return of drugs to wholesaler/mfr Record documenting transfers/sales to other pharmacies, licensees, & prescribers Theft & loss reports of controlled substances (DEA form 106)
Purple Book
Biological products and bio similar interchangeables (highly similar structure and function and has no sig difference in safety and efficacy to reference drug)
Eskalith/lithobid=Depakene/Stavzor=Depakote=Equetro=Lamictal
Bipolar Disorder: *Lithium*(1200mg/d, 0.6-1.2mEq/Lok, >1.5 toxic, CL: renal impairment, SE: Cognitive effects,hand tremor, wt gain, polyuria, polydipsia, hypothyroidism, sedation, DDI: NSAIDs-interfere excretion and ^Li, Diuretics/ACEI/ARB retain Na and Li, SSRIs,SNRIs, triptans, linezolid>^risk of 5HT-syndrome, ^neurotoxicity: verapamil, diltiazem, pheytoin, carbamazepine, haloperidol, bupropion; monitor: BMP, renal function, thyroid function; w/f and 8-12 oz water>decrease Na, dehydration>^Li; ^Na, caffeine>decrease Li)=*Carbamazepine XR*(1600mg/d, 4-12 ug/ml(<20), hepatic disorder, BBW: ski rxs, aplastic anemia, agranulocytosis SE: sedation, SIADH/low Na level, CYP450 inducer, Monitor: LFTs, CBC, platelets,w/f, do not take with milk )*=Divalproex/Valproic*(2000mg/d, 50-125ug/m, max 200, BBW:hepatotoxicity, pancreatitis SEs: sedation, tremor, rash, alopecia, wt gain, thrombocytopenia, CYP450 inhibitor+inducer>avoid combo with antiepileptics, anticoagulants, felbamate and carbapenem, w/f, avoid alcohol, no milk, monitor: LFTs, CBC, platelets)*=Lamotrigine*(400mg/d, 1-4 ug/ml, max<20, hypersensitivity, BBW: seious skin rxs if given with Valproic, SEs: sedation, ataxia, HA, wt loss, minimium CYP450 DIs, plasma levels for dosage adjustment, w/o food chewable & ODT forms available)
CI in CrCl < 30
Bisphosphonates Avanafil Arixtra NSAIDs K-sparing diuretics Tramadol ER Xarelto Pradaxa Cialis Cymbalta (BAANK TX PCC)
Angiomax
Bivalirudin: ACS undergoing PCI and are risk for HIT
Copy 3 of form 222?
Blue - maintained by pharmacy
INH
Blurred vision Photosensitivity
Multiple Prescriber Forms for Hospital and Other Institutions
Boards of medicine and pharmacy allow designated prescriber at a facility that has 25+ physicians to order security rx forms that do not include preprinted prescriber info - Forms need to be signed out by designated prescriber in record book that includes name to whom they were given, category license & number, DEA, qty of forms issues - Keep records for 3 years
When nonschedule & schedule III, IV, & V are lent, borrowed, sold or bought btwn pharmacies, what is the responsibility of the pharmacist & pharmacy
Both pharmacies must keep a log of the transfer whether it is lent, sold, borrowed or bought. CII requires form DEA 222
Copy 1 of form 222?
Brown - goes to supplier
Uceris(rectal foam), entocort EC
Budesonide
butrans
Buprenorphine
SUBOXONE
Buprenorphine + naloxone
Buspar **avoid grape juice
Buspirone Hcl: 5-HT partial agonist 3rd line for anxiety, not controlled. no anticholinergic effects, not sedative, preg-B, but slow onset(2-4 wks for optimal effect), repeat dose, do not use with MAOIs, dividose tablet
Fioricet
Butalbital 50 mg (controlled), caffeine 40 mg, APAP 300 mg
Fiorinal
Butalbital 50 mg (controlled), caffeine 40 mg, ASA 325 mg CIII
for the most part, C2's combined with a non-scheduled drug is what schedule?
C3 with the exception of hydrocodone and oxycodone with acetaminophen or aspirin
What schedule is carisoprodol (Soma)?
C4
What schedule is pregabalin (Lyrica)?
C5
CAIR 1. Age requirement 2. Requirements 3. Notify HCP within ____
CA Immunization Registry 1. Routine immunizations for age 3+ (physician directed protocol may be used if administering non-routine immunization) 2. CDC or ACIP approved immunication training program; maintain BLS; 1 hour of C on immunizations and vaccines every 2 years 3. 14 days
requirements for Advanced Practice Pharmacists
CA licensed pharmacist in good standing with 2 of the following: - certification in relevant area of practice (am care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support, oncology, pediatric pharmacotherapy, psychiatric, etc) - complete post grad residency - provided clinical services to pts for at least 1 year under a collab practice agreement valid for 2 years
Compounding rules: CCR ________
CCR 1735
Human chorionic gonadotropin schedule
CIII in california
CII records should be separate from other records
CIII-V can be separated entirely from both CII & non-controlled OR CIII-V can be incorporated with non-controlled files if marked with a red C
1. Atrovent/Combivent(DuoNeb), Spiriva/StioltovRespimat, Tudorza 2. Brovana=Foradil=Serevent, Arcapta=Striverdi Respimat, Anoro Ellipta=Breo Ellipta 3. Daliresp
COPD: 1. Anticholinergics: *Ipratropium/+Albuterol* q6-8h *Tiotropuim/+olodaterol* QD *Aclidinium* BID: use with caution if myasthenia gravis, glaucoma, BPH SEs: dry mouth, upper respiratory infections, bitter/metallic taste(ipratropium) 2. LABA: MedGuide *Arformoterol=Formoterol=Salmeterol*12h *Indacaterol=Olodaterol*24h *Umeclidinium+Vilanterol=Fluticasone+Vilanterol*: SE: tremor, cough, palpitations, hypokalemia, hyperglycemia 3. *Roflumilast* MedGuide, severe COPD, comb w LABA, SE: N, decreased appetite, abd pain, diarrhea, insomnia, HA CL: liver disease
Neupogen=Neulasta, Procrit/Epogen=Aranesp, Neumega=Leukine
CSFs: *Filgrastim*(IV,SC)*=Pegfilgrastim*(SC): CI if hypersensitivity to E Coli products SE: bone pain, N/V, HA, IV mix with D5W, ok for 6 hrs; *Epoetin**=Darbepoetin*: 1.+RBC-anemia d/t blood loss 2. IV,SC 3. uncontrolled HTN 4. SE: BP, muscle pain, respir infe, DVT BBW: STK, CV events, death, MedGuide, REMS program, increase the risk of death 5. Monitor: Hbg, Hct, iron stones, BP ; *Oprelvekin*(+platelets, SC, anaphylaxis)*=Sargramostim*(+macrophages, IV,SC, peripheral edema) Refrigerate, do not shake
PIC Limits
Can NOT be PIC of pharmacy and designated rep-in-charge (DRIC) for a wholesaler/vet food-animal drug retailer at the same time
Barbiturates scheduling...
Can be II, III, or IV. II: Amobarbital Pentobarbital Secobarbital III: Above three as a suppository or combo + Butalbital and butabarbital IV: Phenobarbital
Delivering CS to Patients
Can be done if - Rx placed in plain outer container or securely wrapped in plain paper - Rx label contains name and address of pharmacy, practitioner, or other person dispensing rx
Delivering Drugs to a Hospital Pharmacy
Can be made to central receiving location but must be delivered to licensed pharmacy w/in 1 working day and RPh must immediately inventory - Drugs placed in secure storage facility in same building as pharmacy - PIC/RPh designated by PIC has access to secure storage facility after drugs/devices delivered - Secure storage facility has means of indicating whether it's been entered after delivery - Pharmacy maintains P&P for delivery - Person delivering leaves documents indicating name and amount of drug/devices delivered - Keep records related to deliveries
Intern Pharmacist Roles
Can do everything a pharmacist does under direct pharmacist supervision BUT can NOT have a key to the pharmacy *All prescriptions filled by intern are checked by RPh before dispensing
Out of State Prescribers
Can fill IF out of state prescriber has license equivalent to that required of california prescriber Control rx's need to meet requirements of state it was written in - CII-V can be mailed to pts - CIII-V can be given directly to pts
Emergency Refills (Non-CS)
Can fill w/o MD auth if MD is unavailable and RPh's professional judgment okays it (failure to refill rx might interrupt pt's ongoing care and have significant adverse effect on pt's well being) - Must reasonably try to contact MD - Notify MD within reasonable amount of time No qty limit - Use professional judgment
Emergency Refills (CIII-CV)
Can fill w/o MD auth if MD is unavailable and RPh's professional judgment okays it (failure to refill rx might interrupt pt's ongoing care and have significant adverse effect on pt's well being) - Must reasonably try to contact MD - Notify MD within reasonable amount of time Provide reasonable amount until MD can be reached Document why filled and that MD was not available on rx
Hypodermic Needle and Syringe Sales
Can furnish to pts w/o an rx if - RPh knows pt and previously provided w/ an rx or other proof of legit medical need for needles and syringes - 18+YO as public health measure to prevent transmission of HIV, etc. No qty limit. - Use on animals (animal's owner known to RPh or identity can be properly established) - For industrial use, as determined by board
Pharmacy Technician Roles
Can perform nondiscretionary tasks (type, fill, etc so long as the task doesn't need RPh judgment) under direct RPh supervision
"Minimum Necessary"
Can share PHI with - Patient - Other HCPs providing care to pt - TPO (treatment, payment, operation) purposes - Part of limited data set for research, public health, institutional operations *Otherwise, RPh must receive pt's written auth to before release
PIC Supervision
Can supervise up to 2 pharmacies within 50mi driving range
Pharmacy Going Out of Business
Can transfer stock but must complete inventory to be used as final inventory of registrant going out of business Also used as initial inventory or registrant acquiring CS *Do not need to send to DEA
Atacand HCT
Candesartan/HCTZ
Date or Name
Cannot be missing from the RX or added for II-V drugs.
Aztreonam
Cayston (inhaled CF); Azactam (IV): PSA, renal, okay with PCN allergy
2nd gen cephs
Cefaclor (Ceclor) Cefprozil (Cefzil) Cefuroxime (Ceftin, Zinacef) Cefotetan (Cefotan) Cefoxitin (Mefoxin)
1st gen cephs
Cefadroxil Cefazolin (Kefzol) Keflex
3rd gen cephs
Cefdinir (Omnicef) Cefditoren (Spectracef) Cefixime (Suprax) Cefpodoxime (Vantin) Cefibuten (Cedax) Ceftriaxone (Rocephin) Cefotaxime (Claforan) Ceftazidime (Fortaz, Tazicef) Avycaz Zerbaxa
Avycaz 3rd
Ceftazidime/avibactam
cefotan 2nd generation
Ceftetan
Zerbaxa 3rd
Ceftolozane
Maintain x at least 4 yrs
Certificate of completion for CE
Who has *dependent authority* to prescribe
Certified Nurse Midwife (CNW) Nurse Practitioner (NP) Physicians assistant (PA)
Who MUST have a collaborative agreement?
Certified Nurse-Midwife NP PA Pharmacists and NPF can also have a collaborative agreement but its not a must if they're acting within their regular scope.
Drug and Vax Shortages
Check - ASHP - FDA - CDC
What are the three ways a prescriber in California can deny substitutions?
Check mark the box Initial the box write on the script "do not substitute"
Board spectrum, BBW: blood dyscrasias and rare, irreversible bone marrow suppresion; SE: gray syndrome of neonates
Chloramphenicol
Peridex (Topical antiseptic)
Chlorhexidine gluconate
Protect from light
Cipro Lasix Levaquin Amiodarone Amphotericin Mycamine Phytonadione Doxycycline Flagyl Flolan Nitropress (CLLAAMPD FFN)
Biaxin
Clarithromycin: metallic taste; 1g daily w/wt food, but XL tab w/f; no refrigerate; QT-prolongation; preg C
Catapres(HTN, off-label for opioid withdrawal, anxiety and sleep); Kapvay(ADHD)=Aldomet=Tenex=Wytensin
Clonidine=Methyldopa=Guanfacine=Guanabenz: central adrenergic a2-blockers
Check for peanut or soy allergy
Combivent (not Respimat) Prometrium
RPh: Tech ratio hospital verses community
Community: 1st pharmacist gets 1 tech, each pharmacist there after gets 2 additional. Hospital: 1 pharmacist gets 2 techs.
1. Metamucil=Citrucel=FiberCo 2. Colace=Kaopectate Liqui-Gel 3. Nujol 4. Dulcolax=Senokot/Ex-lax 5. Citroma=Epsom Salts=MOM=Fleet phospho-soda; Duphalac/Chronulac 6. Amitiza 7. Relistor
Constipation: 1. Fiber/Bulk forming(OTC): *Psyllium=Methylcellulose=Polycarbophil=Prunes*( 1st line, take 2hrs before/after other drugs, safe in pregnancy but take daysto work) 2. Stool softeners(emollients)/surfactants(OTC): *Docusate* preg-C>low risk 3. Lubricants(OTC): *Mineral Oil*(CI in preg, SE: decrease vita abs and bleeding risk with chronic use) 4. Stimulants(OTC): *Bisacodyl**=Senna*8.6mg BID, preg-C *=Castor oil* 5. Osmotic laxatives(OTC and Rx): *Mg citrate=Mg sulfate* preg-C *=MOM* (avoid if kidney disease), Na phosphate; relief of constipation or prior to GI exam/not for long-term use, 0.5-6hrs; *Lactose*(preg-B, alternative for preg) *=Sorbitol 70%=Glycerin supp=Miralax, Carbowax, Golytely(Rx)*(preg-c) 0.5-3 days, used prior GI exams or long-term, avoid if GI obstruction or bowel perforation 6. CL- channel activator*Lubiprostone* for chronic idiopathic constipation and opioid-induced constipation 7. Gut-opioid blocker *Methylnaltrexone* 8-12 mcg SC every other day PRN. Only for use with opioids who have failed docusate+senna or bisacodyl
pancrelipase: cystic fibrosis;no high ph(dairy), no regrigeration required, can sprinkle on soft food such as baby-food pears etc. use right away, do not let your child chew it, just swallow
Creon, lip-prot-amyl,pancreaze, ultrsa, viokace, zenpep
Cubicin**NS only
Daptomycin: 1. Gram+/not pneumonia, MRSA, VRE; 2. SE: rhabdomyolysis(monitor CPK, careful if pt is on a statin) 3. adjust in renal dysf
Prezcobix **take with food
Darunavir(PI)+Cobistat(PI)
SB 493
Declares pharmacist as providers. Establishes advanced practice pharmacist.
Drug Recalls
Defective or potentially harmful drugs Notification by FDA, federal, state, local law enforcement, manufacturers, repackagers Remove drugs from ALL patient care ares and storage locations, including ADDS Do not need to contact pt
Digitek, Digox, Lanoxin
Digoxin
Used in tx of alcohol cessation. **avoid alcohol for 48 hrs e Inhibits acetaldehyde dehydrogenase-->increased acetaldehyde when drinking (toxic)-->N/V-->incentive not to drink
Disulfiram
Drugs by California law which must have a *No not drink Alcohol* sticker
Disulfiram and other drugs (Chlorpropamide, metronidazole) MAOi Nitrates Cycloserine Antidiabetic agents including insulin and sulfonylureas due to risk of hypoglycemia.
Out of Country Prescribers
Do NOT fill
Lasix
Do not refrigerate Protect from light Photosensitivity
Dilantin
Do not refrigerate Saline Filter
IV inotropics for acute HF, to maintain systemic perfusion if pt has low BP/cardiac output; incompatible with bicarbonate
Dobutamine or Milrinone
Ordering and Interpreting Tests
Document w/in 24hrs in EHR (or something like EHR) so healthcare team can access - Interpret results - Rationale for decision - Info provided to pt and healthcare team members
Pharmacy Selling CS
Does not need distributor/wholesaler registration if total number of CS dosage units does not exceed 5% of total number of CS dosage units dispensed per calendar year - Use DEA 222 form and rules
Anzemet
Dolasetron (po for CINV, no IV for QT prolongation)
Triumeq
Dolutegravir(INSTI)+abacavir(NRTI)+lamivudine(NRTI)
Prescription Errors/Omissions
Don't need to call MD to revise - Minor spelling Need to call MD to revise - Date/sig missing *Document discussion
CS Inventories
Done at open or close of business day and recorded inventory Documentation must include - Date of inventory - Inventory taken at beginning of close of business day - Names of CS - Dosage forms and strengths - Number of dosage units/volume in each container - Number of commercial containers
Sinemet(tab), Rytary(ER cap to open and mix), Duopa(enteral suspension given J-tube); +comtan=Stalevo
Dopaminergic agents: Carbidopa/Levodopa :1. gold standard; most effective; ok in elderly 2. iron and protein-rich food decrease absorption 3. SE: dark urine, N/V, anorexia, dizziness, orthostasis but HTN if taken w MAO Is, dyskinesias(abnormal mov) 4. preg-C 5. tablet can be cut in half ; +Entacapone 1. COMT-I: with levodopa only to ^duration, max 1600mg/d 2. SE: similar, dark urine
OSMOTIC Laxatives≡ Hydrating agents (OTC and Rx)
Draw water into the large intestine SALINE cathartics 0.5-6 hrs Quick relief of constipation or prior to GI exam/ Not for long-term use Magnesium & Phosphate salts: ↑ Mg and phosphorus. Avoid if kidney disease Sodium laxatives: Avoid in patients with salt restricted diet (CHF, kidney disease, hypertension) Magnesium citrate (Citroma), Magnesium sulfate (Epsom Salts). Pregnancy Cat C Magnesium hydroxide (Milk of Magnesia, MOM) (OTC) Sodium Phosphate (Fleets Phospho-Soda) (OTC) HYPEROSMOTIC 0.5 hrs- 3 days Not absorbed by the body. Used prior GI exams or long-term Avoid use if GI obstruction or bowel perforation Lactulose (Duphalac, Chronulac) (Rx) Preg. Cat. B Alternative for pregnancy Sorbitol 70% (OTC) Glycerin supp (OTC) Polyethylene glycol: MiraLax (OTC); Carbowax, Golytely (Rx) Preg. Cat C Laxative of choice in pregnancy
Multaq （Antiarrhythmic）
Dronedarone
1. Levitra/Staxyn ODT=Viagra/Revatio=Cialis/Adcirca 2. Caverject 3. Prostacyclin/Flolan=Ventavis=Tracleer
ED: 1. PDE inhibitors *Vardenafil*(5-10mg, 1h before activity on empty stomach)*=Sildenafil*(25-50mg 1hr before activity on an empty stomach, 20mg TID for pulmonary arterial HTN)*=Tadalafil*(10mg 1h before sex or 2.5-5mg QD without regard to timing of activity w/o f, daily use is FDA approved for mild symptom improvement of BPH; 40mg daily for pulmonary arterial hypertension): CI with nitrates d/t severe hypotension 2. *Alprostadil* intracavernosal injection into penis (refrigerate) 3. Also for pulmonary hypertension: *Epoprostenol*(protect from light Vasodilator)*=Iloprost=Bosentan*(Endothelin Receptor Antagonists, birth control less effective, BBW: hepatotoxicity, birth defects, REMS program)
6 of the 30 Pharmacist CE hours must be in...
Emergency/ Disaster Response Patient Consult Drug Inventory Ethics Substance abuse, including indications of red flags and pharmacist responsibility Compounding
Atripla (QHS) no food
Emitricitabine(NRTI)+TDF(NRTI)+Efavirenz(NNRTI)
Odefsey **NNRTI-birth control less effective
Emtricitabine(NRTI)+TDF(NRTI)+Rilpivirine(NNRTI)
Emtriva+Viread(w/f)=Truvada; +sustiva=Atripla; +Edurant=Complera(w/f); +INSTI+tybost=Stribild(w/f)
Emtricitabine(NRTI)+TDF(NRTI); +Efavirenz; +Rilpivirine; Elvitegravir+cobicistat 1. CNS and psychiatric ssx. be careful if you drive. avoid alcohol 2. take w/f 3. cobicistat does not have any antiviral activity. boosts the blood levels 4. Truvada+Raltegravir are post-exposure PPRX for 4 wks 5.
Fuzeon
Enfuvirtide: HIV fusion inhibitor 90mg SC BID.Very painful inject not commonly used. Salvage therapy (not affected by CYP450, no DDI)
Transaction Statement
Entity transferring ownership - Is authorized - Received product from authorized persons - Received transaction info and transaction statement from prior owner of product - Did not knowingly ship suspect of illegal product 0 Had systems and process to comply with verification requirements - Did not knowingly provide false transaction info - Did not knowingly alter transaction history
Complete CIII-CV inventory
Every 2 years
Taking of a controlled substances inventory
Every 2 years & kept on site for 2 years. CIII-V: if substance is in bottle > 1000 then need EXACT count
Complete RPh CE (30hrs) when
Every 2 years, except first cycle
Pharmacist continuing Education (30 hours)
Every 2 years, except first cycle.
Frequency of all controlled substance inventory reconcilliation.
Every 2 years.
Period one must renew license to continue to practice pharmacy
Every 2 yrs. If license not renewed within 3 yrs of date renewal was due, it shall not be renewable
Hospital Drug Supply Inspection
Every 30 days by pharmacist, intern, tech - Includes ADDS, fridge, freezer, emergency supply stock - Report irregularities w/in 24hrs to PIC and director or CEO *Keep records for 3 years
Complete CII inventory
Every 3mo *Keep inventory records away from others
Frequency of C2 inventory reconciliation.
Every 90 days.
Complete self-assessment form when
Every odd-numbered year before July 1st AND W/in 30 days when change in pharmacy permit, change in pharmacy location, change in PIC
Auxiliary Labels
Evidence-based and written in simple language
Aromasin (aromatase inhibitor)
Exemestane
Deferasirox (TAKE 30 minutes before eating on empty stomach - this may cause gastrointestinal hemorrhage) - can be used for sickle cell somehow
Exjade
Therapeutic Equivalence (Orange Book)
First letter A = Therapeutically equivalent First letter B = Not equivalent Second letter = Route of administration Therapeutic Interchange Protocol is dispensing meds by RPh that are chemically different but therapeutically similar - Needs presence of functioning formulary system and P&T committee
Checking DEA Validity
First letter: License type Second letter: First letter of last name 1. Add up 1st, 3rd, 5th numbers 2. Add up 2nd, 4th, 6th numbers --> Multiply by 2 3. Add numbers from step 1 & 2 4. Last digit of sum from step 3 is equal to last digit in DEA license
Discoloration
Flagyl Levodopa Entacapone Macrobid Phenazopyridine
Addyi
Flibanserin Female sexual health This is a medication to treat decreased sexual desire in some women.
Fluticasone
Flovent Flonase nasal, Veramyst( nasal)
Tamiflu=Relenza=Rapivab
Flu: *Oseltamivir*(preg-c, 75mg BIDx5d, PPX: QDx10d, age>1)*Zanamivir*(oral inhalation, preg-c, 10mg BIDx5d, PPX:QDx10d, age>=7)*Peramivir*(Injection, preg-c, 600mgIVx1 within 2days of sym onset, age>=18)
Ancobon/5-FC
Flucytosine 1. convert to fluorouracil 2. bone marrow suppression 3. rapid resistance if mono 4. =caspofungin(cancidas)=Micafungin(Mycamine) for systemic fungal infection
ICS: Inhaled corticosteroids
Fluticasone (Flovent)/+ Salmeterol= Advair MedGuide Beclomethasone (QVAR) Triamcinolone (Azmacort) Flunisolide (Aerospan, Aerobid) Ciclesonide (Alvesco) Mometasone (Asmanex)/+ Formoterol= Dulera MedGuide Budesonide (Pulmicort)/+ Formoterol= Symbicort Respules for neb. Budesonide→ preferred inhaled corticosteroid in pregnancy
Alimta=Trexall (oral)/otrexup and rasuvo (SC)/Xatmep (oral solution)/ Rheumatrex/Mexate
Folate Antimetabolite: *Pemetrexed**=Methotrexate*(antidote: leucovorin/folic ac)
CURS
For CII-IV Submit dispensing data WEEKLY All CA RPhs must be registered HCP must review CURES no earlier than 24hrs or previous business day before prescribing CII-IV
How long should patient medication error documentation records be kept
For at least 1 year
OD
For codeine- or hydrocodone-containing products, can prescribe a max 3-day supply (license # T)
Ordering CII?
Form 222 CSOS (Controlled Substance Ordering system )
Transfer CII to original supplier
Form 222 needs to be issued
Monurol
Fosfomycin: 3g *1 for UTI in pregnant, +beta lactams treat for 7 days to prevent premature birth or pyelobephritis; cause diarrhea
dalteparin Brand?
Fragmin
Lasix=Demadex=Bumex=Edecrin
Furosemide=Torsemide=Bumetanide=Ethacrynic(50mg inj okay if sulfa allergy; light sensitivity, ototoxicity>>not with AMGs): DOC if renal disease, edema in HF, need K supp; metabolic alkalosis; SULFA(photosensitivity, rash)
1. Amphojel=AlternaGEL, MOM=Phillips' Relief=Saline Laxative, Maalox=Mylanta, Rolaids=TItralac=Tums, Alka-Seltzer 2. Zantac=pepcid=Axid=Tagamet 3. Prilosec=Zegerid=Nexium=Prevacid=Dexilant=Aciphex=Protonix 3. Reglan 4. Carafats, Cytotec, Bismuth subsalicylate
GERD: 1. OTC antacids: *Al, Mg, Al+Mg, Ca, Na*: Max 6x/day, onset<5min, last 2hr 2. H2-RA: *Ranitidine*(150mg BIDAC-preferred)*=Famotidine*(20mg BIDAC)*=Nizatidine*(only one not available as inj)*=Cimetidine*(many SEs and DIs. Avoid w clopidogrel): preg-B, SEs: rash, fatigue, HA, diarrhea and constipation, onset 1h, last 12h 3. PPI: *Omeprazole**=Omeprazole/Na bicab**=Esomeprazole**=Lansoprazole**=Dexlansoprazole**=Rabeprazole**=Pantoprazole*: preg-B or C, onset 2h, last 24h, SEs: DIs ^INR w Warfarin, ^risk for PNA and C. diff; osteoporosis/bone fractures(long-term), MedGuide, DO NOT CRUSH, OTC label: for>=18 yo, max 14dtx, max 1 course tx q4m 3. *Metoclopramide* When other meds fail, short-term use, 10mg QID AC must be ingut when food is present. SE. dizziness, worsening of PK, TD(it's s dopamine antagonist), MedGuide 4. Cytoprotective*Sucralfate* QID on empty stomach(do not take antacid within 3oming and seperate from other drugs 2h before and 4h after), AL>constipation, avoid if renal disease, Ok in pregnancy. *Misoprostol* (PG analog for NSAIDs induced ulcers) pregnancy Cat X *OTC pepto-Bismol*
Lopid(30mins before breakfast and dinner)=Triglide, Tricor, Trilipix, Lipofen, Antara(take with food and MedGuide)
Gemifibrozil=Fenofibrate: 1. fibrates, 2. CI liver, renal and gallbladder disease(cholelithiasis) 3. Rhabdomyolysis, myopathy, especially gemifibrozil
Depakene/Stavzor=Depakote=Lamictal=Keppra=>Dilantin=Cerebyx=>Tegretol/Carbatrol/Epitol=>Trileptal=>Topamax=>Zonegran
Generalized Tonic-Clonic: *Valproate or valproic acid=Divalproex=Lamotrigine=Levetiracetam=>Phenytoin=Fosphenytoin=>Carbamazepine=>Oxcarbazepine=>Topiramate=>Zonisamide*
Peak (30 min after infusion) and trough (q8h before next dose)monitoring; BBW: nephro(reversible); oto(irreversible); neuromuscular blockade>respi paralysis, neurotoxicity preg-C/D
Gentamicin; Tobramycin (TOBI inhale for CF); Amikacin (broadest activity)
Tenofovir alafenamide: HIV take with food
Genvoya
IM Vax
Given into muscle, usually deltoid - 1 inch (1.5inch if woman >200lbs, man >260lbs) - 22-25 gauge - 90 degree angle *Separate multiple vax on same arm by 1inch
Notice of Privacy Practices
Given to pt on first day service is provided - Pharmacy cannot deny service if the pt refuses to sign. Document refusal. - Pharmacy must make good faith effort to obtain pt's written acknowledgement they received notice Place notice in prominent location w/in pharmacy and on pharmacy website
Patient Package Inserts
Given with each rx in outpt setting - FDA approved - Required for all estrogen containing drugs Given before first dose and every 30 days thereafter in inpt setting - If not provided, then considered misbranding
MedGuides
Given with rx's that have significant health concerns - FDA approved - Supplied by manufacturer either by efile or physical handouts Give in each of the following situation - Every fill in outpt setting and when drug will be used by pt without supervision of HCP - First time drug is dispensed to HCP for administration to a pt in an outppt setting - When pt or caregiver asks for it - If MedGuide has been revised - If drug is subject to REMS, which requires a MedGuide Given for - Antidepressants - Some antipsychotics - Anticonvulsants - LABAs - Most antiarrhythmics - NSAIDs - Some insomnia - Some ADHD
1. Travatan Z=Lumigan=Xalatan=Zioptan 2. Timoptic=Betoptic S=OptiPranolol=Betagan=Ocupress 3. Azopt=Trusopt/Cosopt=Diamox 4. Alphagan/Combigan 5. Salagen (Saliva production stimulator and glaucoma medication)
Glaucoma: 1. Prostaglandin Analogs: *Travoprost=Bimatoprost=Latanoprost*(refri)*=Tafluprost*(refri, preservative free): 1st line, MOA: ^aqueous drainage, QHS, take 3wks to work, SEs: brown pigment in the iris, eyelash growth, inflammation 2. BB: *Timolol=Betasolol=Metipranolol=Levobunolol=Carteolol*: fast acting, QAM or BD, SE: bronchospasm, bradycardia, hypotension, decrease libido, CNS depression, CL: Pts with asthma, COPD, bradycardia 3. Carbonic Anhydrase Inhibitors: *Brinzolamide*(susp>shake)*=Dorzolamide/+timolol=Acetazolamide*(diuretic): BID or TID, SE: metallic taste, HA, aplastic, anemia, hypokalemia CL: sulfa allergy, kidney disease 4. Alpha Agonists/Adrenergics: *Brimonidine/+Timolol* BID or TID, SE: dry mouth, fatigue, CL: MAOIs use 5. Cholinergics: *Pilocarpine* QID no longer use d/t SEs
PKI: *Imatinib*: leukemia; take with food=*Erlotinib*=*Everolimus*=*Dasatinib*=*Nilotinib*=*Sunitinib*=*Sorafenib*=*Gefitnib*=*Lapatinib*
Gleevec/Glivec=Tarceva=Afinitor=Sprycel=Tasigna=Sutent=Nexavar=Iressa=Tykerb
1. Colcrys 2. Indocin=Clinori=Naprosyn=Celebrex 3. Zyloprim, Aloprim=Uloric
Gout Acute attack: 1. Colchicine(SE: N/V diarrhea; MedGuide); 2. Indomethacin(DOC)= Sunlindac=Naprosyn=Celecoxib; 3. Prednisone=Methylprednisone=Triamcinolone Tx: 4. decrease UA production: Allopurinol=Febuxostat 5. Probenecid; Losartan; fenofibrate PPX: 6mos before initiation to avoid crystal mobilization, do not stop for gout attack 6. Naproxen 250mg BID 2. Colchicine 0.6mg QD or BID
hydrocodone bitartrate extended-release
HYSINGLA ER (hydrocodone bitartrate) extended-release
Microzide=Diuril=Thalidone=Zaroxolyn(ok if renal dys)=Lozol
Hydrochlorothiazide=Chlorothiazide=chlorthalidone=metolazone=indapamide: DOC; SULFA (photosensitivity, rash ); Metabolic alkalosis: decrease K&Na, increase BG,TG/cho &UA, Ca
1. Azulfidine/sulfazine=Asacol/Pentasa/Lialda/Canasa supp/Rowasa enema 2. Imuran=Purinethol=Rheumatrex 3. Remicade=Humira>Enbrel=Cimzia=Tysabri
IBD: 1. Aminosalicylates: *Sulfasalazine*(avoid if sulfa allergy! 4-6g/d, w/f, yellow-orange skin/urine, decrease folate abs, photosensitivity, take with water and food)*=Mesalamine*(1g PR Qday or 1.5-4.8g/d PO) 2. Immunosupressives *Azathioprine*(protect from light)*6-Mercaptopurine*(Bone marrow tox: anemia, leukopenia, thrombocytopenia) *Methotrexate* (Preg-X, antidote leucovorin. Monitor CBC, LFTs) 3. Monoclonal antibodies: *Infliximab*(IV q8w also for RA, filter+NS only for 3 hrs, pre-med w APAP, antihistamine, and steroids for infusion-related reactions such as amphotericin) *Adalimumab* (40mg SC, RT for 14D, BBW: fatal infection, malignancy, tuberculosis>same to *Etanercept*)*Certolizumab*(400mg SC) *Natalizumab*(BBW: progressive multifocal leukoencephalopathy-TOUCH program) 4. *Alosetron* can help women who have diarrhea as the main symptom. REMS program 5. Antispasmodics: *Dicyclomine* *Hyoscyamine*Phenobarbital+Belladonna alkaloids(atropine, hyoscyamine, scopolamie) 6. *Budesonide=prednisone* (short-term for acute flare-ups)
medium risk
ISO 5 PEC, ISO 7 buffer area and ISO 8 multiple individial or small doses of sterile prodcuts combined to prepare a csp for multiple patients or for one patient on multiple occasions more than 3 ingredients complex aseptic manipulations ex: using a multi-dose vial of antibiotic and transferring single doses to several normal saline IV bags for multiple patients. this process is called batch preparation. preparing total parental nutrition
Compounding sterile injectables from nonsterile ingredients
ISO class 5 laminar airflow hood with ISO class 5 cleanroom. Certification for sterile compounding records should be maintained for at least 3 yrs. For parenteral cytotox agents --> MUST use Class II type A or type B vertical laminar air flow hood with bag in bag out design
Tramadol in California is schedule
IV FOUR.
Schedule and Refill Limits IV III II
IV: 5 Refills or 120 day supply, which occurs first. III: 5 Refills or 120 day supply, which occurs first II: 0 Refills
Corvert
Ibutilide (Antiarrhythmic)
Automated Drug Delivery System (ADDS)
If located in skilled or intermediate care facility, it's required - Pharmacy and nursing facility developed P&Ps to ensure drugs are being stored and dispensed properly - RPh reviews each med order and the pt's profile before drug is removed from ADDS (override in emergency situations only) - When cabinet is stocked directly in the facility, stocking is done by pharmacist - If ADDS uses removable pockets, drawers, or similar tech, stocking is done outside the facility (at pharmacy) and delivered back to facility (must be temper evident containers, restocked by pharmacist/intern/tech) Drugs labeled with name, strength, dose form, manufacturer, manu lot number, exp date *Needs DEA-registered pharmacist if used to store/dispense CS
Counseling for Mailed Rx's
If mailed or delivered, there must be a written notice that RPh is available if pt has any questions and a telephone number that the pt can call
1 of the 30 Pharmacist CE hours must be in....
Immunizations and Vaccines
Revlimid=Proleukin=Aldara=Thalomid
Immuno-modulators: *Lenalidomide*( myelodysplastic syndrome (MDS), multiple myeloma, and mantle cell lymphoma (MCL)*=Aldesleukin,IL-2**=Imiquimod*(DOC genital warts: 3x/wk for max 16 wks, QHS, wash off after 8 hrs; also for basal cell carcinoma and actinic keratosis)*=Thalidomide*(treat and prevent a skin disease caused by leprosy (erythema nodosum leprosum). It can also be used with dexamethasone to treat multiple myeloma; severe-birth defect>restricted:STEPS program)
Patient presents to pharmacy from out-of-state with empty labeled RX for digoxin that she's been on for 10 yrs. No refills remaining. Can pharmacist refill?
In best interest of patient to refill, but violation of law b/c pharmacy doesn't have record of medication. If pharmacist call out-of state pharmacy & request copy of RX then may fill emergency supply.
Misbranding
Incorrect/missing info on label - False/misleading product info promising cures, etc - Lack of special precautions o prevent decomposition - Illegible info - No branded name included on label or established common name - Ingredients differ from standard of strength, quality, purity, as determined by test laid out in USP monograph - Does not include manufacturer, business location, packer, distributor - Improper packaging/incomplete labeling of additives - Deficiency in packaging according to Poison Prevention Packaging Act
Registered Pharmacist (RPh) Prescribing Authority
Independent authority (per state protocol), limited to - ECs, self administered hormonal contraception - Travel meds rec'ed by CDC, not requiring diagnosis - Routine immuns published by CDC for 3+ YO - Naloxone - Rx NRT products Dependent authority *all other non-CS, C2-5* *Must register with DEA for CS
Naturopathic Doctors (ND) Prescribing Authority
Independent authority, limited to: - ND license numbers will *start with NDF* - Epi to treat anaphylaxis - Natural/synthetic hormones* - Vitamins, minerals, AAs, glutathione, botanicals/extracts, homeopathic meds, electrolytes, sugars, diluents Dependent authority (under MD's scope) - All OTHER non-controlled and *C3-C5** *Must register with DEA for CS
UFH=Lovenox=Fragmin=Innohep=Arixtra
Indirect Thrombin Inhibitor to prevent clots: *Heparin=Enoxaparin=Dalteparin=Tinzaparin=Fondaparinux*(DOC HIT): both SC and IV; safe in pregnancy; contains benzyl alcohol(preservative)>CL in neonates; Only heparin no renal, but need monitor aPTT, osteoporosis and hyperkalemia
Pt Medication Profiles
Info required - Pt name, address, phone, DOB, gender - For each rx dispensed by pharmacy - Drug name, strength, dosage form, route of administration, qty, sig - MD name, license number, and DEA prn - Date each drug was dispensed or refilled - Rx number for each rx - Allergies, idiosyncrasies, current meds, relevant prior meds, OTCs, devices, med conditions if provided - Any info RPh feels is necessary Keep 1 year from date last rx was filled unless - RPh feels pt will not come back to the pharmacy
Classes with MedGuides
Insomnia drugs Some antipsychotics: Abilify, Seroquel LABAs Antidepressants ADHD drugs NSAIDs DM drugs Retinoids Most antiarrhythmics: amiodarone
Lantus Solostar**all insulin avoid alcohol
Insulin Glargine
Humalog>>Afrezza=Novolog=Apidra
Insulin Lispro=Aspart=Glulisine: rapid acting
Intro A=Pegasys=Peg-Intron: pegylated ^t1/2 and allow weekly dosing
Interferon alfa 2b=PEG-IFN alfa-2a=PEG-IFN-2b: 1. BBW worsening autoimmune, infection, psychiatric, ischemic, blood 2. refri, inject in thigh, abd or upper arm &rotate 3. Eltrombopag(promacta) treat thrombocytopenia 4. 48 wks
If an ADS has removable pockets, what happens?
It can be taken to the pharmacy and a tech, intern or pharmacist can load it. Verses the ADS that aren't removable which can only be filled by a pharmacist.
Sporanox(nail fungal infection), Onmel(cap and sol are not interchangeable)
Itraconazole 1. take with food for cap, 2. BBW-HF 3. avoid antacids, H2RAs, PPIs
Self-assessment pharmacy records
Kept for 3 yrs. Completed by July 1st each ODD year. Complete self assessment within 30 days of a new pharmacy permit issuance or change of PIC
a dissociative anesthetic drug, similar to PCP, that acts as an NMDA receptor antagonist; ketalar
Ketamine CIII
restriction on iodine containing products
LIMIT - 8oz of 1% betadine or povidone - 1oz of 2% iodine tincture
Vimpat Anticonvulsant Seizures
Lacosamide (C-V)
Epivir
Lamivudine(NRTI)
Epivir+Retrovir=Combivir; +Ziagen=Trizivir BID, hematotoxic
Lamivudine(NRTI)+Zidovudine(NRTI); +Abacavur: 1. Pregnancy prefer Combivir, also add nevirapine(Viramune) or potent PI (Kaletra), Efavirenz is CI
Fluvastatin=Lovastatin=Pravastatin=Simvastatin=Atorvastatin=Rosuvastatin=Pitavastatin: 1. Preg-X 2. caution Rhabdomyolysis & Myopathyl 2. monitor PT/INR if pt takes warfarin
Lescol(HS), XL=Mevacor(IR w/f), Altoprev ER(HS)=Pravachol=Zocor(HS)=Lipitor=Crestor=Livalo: red yeast rice least to most potent
NDF before license #...
Lets a naturopathic doctor prescribe... They can also go into a Colllaberative agreement. Epinephrine to treat anaphylaxis Natural and synthetic hormones including testosterone Vitamins, minerals, amino acids,
Linzess: CIC/IBS-C; increase CL and bicarbonate>decrease GI transit time; **no for <6 years old; original container; do not BCC; MedGuide=Plecanatide/Trulance
Linaclotide
Soliqua
Lixisenatide+insulin glargine
Drug Storage for Controlled Drugs
Locked cabinet or dispersed throughout other drug stock (on shelves)
Amitiza
Lubiprostone
*Nardil=Marplan=Parnate= Emsama(patch); eldepryl(Parkinson), zalapar(ODT)*
MAOIs 3rd line for depression: *Phenelzine=Isocarboxazid=Tranylcypromine=Selegiline=St. John's Wort* TD: 1. restricted to pts do not respond to other tx d/t safety concerns 2. SE: Anticholinergic, orthostasis, sedation, sexual dysfunction, wt gain, avoid comb with tricyclics, SSRIs, SNRIs, triptans and tyramine foods ((HTN crisis separate 5 wks) 3. daily patch upper chest, back, upper thigh, upper arm
Who has independent authority to prescribe C2-C5? (4 + 1)
MD/DO Dentist (DDS) Podiatrist (DPM) Veternarian (DVM) Optometrist (OD) - can prescribe 3 days worth of tramadol-, codeine-, or hydrocodone-containing products.
M-M-R II
MMR: (Measles, mumps, rubella) SC, live attenuated, avoid in pregnancy/weakened immune system/HIV CD4<200
1. Avonex(IM weekly)/Rebif(SC TIW)=Betaseron/Extavia=Copaxone=Tysabri=Novantrone 2. Gilenya=Ampyra=Aubagio=Tecfidera 3.Lioresal/Kemstro=Dantrium
MS: 1. Injectable Immune Modulators: *Interferon beta-1a*(30mcg IM qw or 22-44mcg SC mcg TIW, refri, MedGuide) *=Interferon beta-1b*(0.25mg SC every other day, refri, MedGuide)*=Glatiramer*(20mg SC QD refri) *=Natalizumab*(300mg IV q4w, refri, MedGuide) *=Mitoxantrone* (IV q3m) 2. Oral Immune Modulators: *Fingolimod*(MedGuide)*=Dalfampridine*(MedGuide)*=Teriflunomide=Dimethyl fumarate* 3. Muscle relaxants: *Baclofen=Dantrolene*
CMS Rx Requirements for Writtn/Non-eRx
MUST be on tamper resistant pads for Medi-Cal outpt drugs (incl OTC, noncontrols, controls) in order to be reimbursed by gov't Security features must include: 1. Prevent unauth'ed copying of completed/blank rx form 2. Prevent erasure or mod of info written on rx by provider 3. Prevent use of counterfeit rx *Cali security forms exceeds above requirements
Patient medication profile.
Maintained x 1 year.
Pseudoephedrine, ephedrine sale logs.
Maintained x 2 years.
Community or Clinic pharmacy prescriptions.
Maintained x 3 years.
DEA Form 222
Maintained x 3 years.
Hospital pharmacy chart order records for non-CS.
Maintained x 3 years.
Purchase invoices for all rx drugs.
Maintained x 3 years.
Record documenting return of drugs to wholesaler or mfg (retained for how long?)
Maintained x 3 years.
Record documenting transfers or sales to other pharmacies, licensees, and prescribers.
Maintained x 3 years.
Self-assessment forms.
Maintained x 3 years.
Theft and loss reports of controlled substances (DEA Form 106)
Maintained x 3 years.
Certificate of completion for CE.
Maintained x 4 years
Biennial CS inventory record.
Maintained x 4 years.
Patient acknowledgment of HIPAA.
Maintained x 6 years.
Transaction info, transaction hx, transaction statements for each drug product received ex: when selling/transferring drugs (transferring ownership of a drug)
Maintained x 6 years.
Hospital pharmacy chart order records for controlled substances.
Maintained x 7 years.
Osmitrol and Nimotop>start within 96h of the onset of subarachnoid hemorrhage. the cap contains liquid, NG okay, not for IV(BBW)
Mannitol and Nimodipine: DOC hemorrhagic stroke to decrease intracranial pressure
Manufacturing vs Compounding
Manufacturing - FDA - FDA drug approval process; label with adequate directions for use; CGMP - No individual rx required - Interstate distribution okay Outsourcing Facilities - FDA, BOP - 503B, CGMP, USP - No individual rx required - Interstate distribution okay Traditional Compounding - BOP - 503A; USP - Individual rx required - Interstate distribution okay up to 5% of total sales only
Faxed RX
May accept as original RX if sent by MD, PA, NP, CNM, & ND for nonscheduled & CIII, IV, & V. If faxed by patient, need original or call MD to take telephone order. Require initials of sender
Naturopathic doctors
May independently write for or furnish natural or synthetic hormones W/O physician directed protocol IF natural or synthetic drug is NOT controlled substance like testosterone (CIII). To prescribe testosterone need supervising MD & DEA license
Central location recordkeeping for controlled substances
May occur 14 days after DEA received notice
PIC
May serve as a PIC at 2 pharmacies as long as the 2nd pharmacy is not more than 50 miles. Can't serve as PIC if already an exemptee in charge for a vet drug food retailer at another site.
Buprenorphine is a REMS drug
MedGuide ↓ dose for chronic pain. ↑ dose to treat addiction Binds to the mu receptor and blocks other opioids' effects ↓ opioid cravings/ withdrawal sympt. and discourages use of illegal opioids. Acts as antagonist if other opioids are used for >1 wk Prescribers need Drug Addiction Treatment Act (DATA 2000) waiver. If they have it, the DEA number will start with X
NSAIDs
MedGuides Photosensitivity CI in CrCl < 30
Menactra&Menveo=Menomune=Trumenba&Bexsero=MenHibrix
Meningococcal: *Conjungate(A,C,W,Y)-MCV4*(IM, 2mo-55yo) *Polysaccharide(A,C,W,Y)-MPSV4*(SC,>=2yo) *Serogroup B-MenB*(IM, 10-25 yo) *Conjugate(C,Y and Hib)* (IM 6wk-18mo): none contains live bacteria
DEMEROL CII
Meperidine (short-action, 3h, for acute pain ie sutures in ER, SE: serotoninergic, CNS tox in elderly/renal ds)
Mesnex
Mesna (PPX to ifofamide for hemorrhagic cystitis)
a stimulant that is related to amphetamines, but is even more powerful; Dexosyn; Desoxyn CII
Methamphetamine
UREX
Methenamine: 1. urinary antiseptic to prevent recurring UTIs 2. avoid alkalinizing foods/meds 3. monitor liver function 4. preg-C
Metadate CD, Ritalin LA, Concerta ADHD, contempla XR-ODT, methylin, quili chew ER, Quillivant XR, Aptensio XR, Daytrana(flush or put in lidded trash can; alternate hips each morning) (It can treat ADHD and narcolepsy)
Methylphenidate ER CII
Ritalin=Methylin=Methyl ER=Aptension XR=SODAS=Daytrana TD patch(hip QAM)=Concerta OROS=Metadate CD; Vyvanse; Focalin(SODA); Dextrostat, Dexedrine; Adderall
Methylphenidate; Lisdexamfetamine(1st line, prodrug, less abuse); Dexmethylphenidate; Dextroamphetamine; Amphetamine mixed salt(scored tabs): 1. BBW: heart, psychiatric, children/teenagers 2. MedGuide 3. 2 days to work with IR to XR 4. CL if glaucoma, hx of tics, w/MAOIs 5. SE:GI, reduced appetite after meal, insomnia(QAM), withdralrxs, HA
Reglan
Metoclopramide (It can treat gastroesophageal reflux disease (GERD). It can also treat gastroparesis in patients with diabetes)
Flagyl; Tindamax **1. avoid alcohol to 48 hrs tinidazole; 2. photosensitivity; 3. discoloration 4. no refrigerator IV form (crystals redissolve @RT)
Metronidazole; Tinidazole : 1. DOC for C. diff, bacterial vaginosis, amoebiasis, giardiasis, trichomoniasis; 2. w/f&milk&water 3. ***CNS and convulsive seizure, leukopenia, neutropenia, metallic taste, furry tongue, darken urine, disulfiram-like Rx with alcohol 4. preg-B 5. CYP 2C9 inhibitor>>^INR warfarin and effect birth control
Neosporin=Polysporin=Bactroban
Minor cuts/Abrasion: *Polymyxin+bactracin+Neomycin=Bacitracin+Polymyxin=Mupirocin*(Rx abx cream/oit with good staph and strep coverage); Tenanus vaccine: current and q10yr
Rituxan, Erbitux, Avastin, Herceptin, Yervoy, Campath, Mylotarg, Zevalin, Bexxar
Monoclonal ab chemo: *Rituximab*(CD20 antigen inhibitor) *Cetuximab*(EGFR inhibitor) *Bevacizumab* (VEGF Inhibitor) treat colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancer *Trastuzumab* (HER2 inhibitor) *Ipilimumab*, *Alemtuzumab*, *Gemtuzumab*, *Ibritumomab*, *Tositumomab*
1. Soma=Lioresal=Flexeril=Skelaxin=Robaxin; Zanaflex; Diazepam 2. Lyrica, Cymbalta, Neurontin, Elavil 3. Savella 4. Lidoderm, Zostrix
Muscle relaxant: 1. *Carisoprodol* C-IV *=Baclofen* *=Cyclobenzaprine* *=Metaxalone* *=Methocarbamol*(discoloration) May cause drowsiness, do not operate machinery;*TIzanidine; Valium* 2. Neuropathic Pain: *Pregabalin*CV, MedGuide, Diabetic neuropathic pain/post herpetic neuralgia/fibromyalgia/adjunctive partial seizure *=Duloxetine* for Peripheral neuropathic pain/fibromyalgia/chronic musculoskeletal pain/depression/generalized anxiety disorder, MedGuide, SE: dry mouth, somnolence, fatigue, appetite *=Gabapentin*off-label for neuralgia, ER take Gralise(post herpetic neuralfia) w dinner&take horizant(for restless leg) 2h prior sleep *=Amitriptyline* Overdose(suicidal)>QT-prolongation 3. *Milnacipran* for fibromyalgia 4. Topical agents: *Lidocaine 5% patch* max 3 patches once, 12h on, 12h off, can cut into smaller pieces, *Capsaicin 0.025% and 0.075%* TID-QID. long-term use for benefit
Patient Right to Obtain Records
Must be able to inspect med record w/in 5 business days of making written request and receive copies w/in 15 business days - Max charge for copies is $0.25/page or $0.50/page if copies are made from microfilm, plus addition of reasonable clerical costs - Can request mailed or emailed
Interpretive Services
Must be provided during all hours pharmacy is open, either in person, by pharm staff, or third party interpretive services via phone
Renewal time period on a pharmacy permit
Must be renewed yearly
PIC Self-Assessment
Must complete biennial (every other year) self-assessment before July 1 of each odd number year AND! Within 30 days if new permit, change in PIC, or change in pharmacy location *Keep self-assessments for 3 years
Pharmacy/Outsourcing Facility Recall
Must contact recipient pharmacy, prescriber, pt of recalled compounded drug preparation w/in 12hrs and to BOP if both below apply: 1. Use/exposure can cause serious ADR or death 2. Item was intended for use in CA
Sale of hypodermic needles & syringes
Must have RX OR patient known to pharmacy & previously had RX to buy needles/syringes for medical tx. Other exception to RX requirement = for animal use or specialcity declared disease prevention programs such as AIDs & Hep C prevention & pharmacy is registered for the project to give out needles/syringes OTC (max of 10) but patient must be > 18yo
Nuclear Pharmacy
Must have sterile compounding permit from the BOP
Handling Hazardous Drugs
Must have the following - Engineering controls that vent toxic fumes to outside - PPE - Safe work practices, spill kits, disposal requirements
Transferring of business (with controlled substances)
Must notify special agent in charge at least 14 days before transfer. A complete inventory must be done the day of transfer. Form 222 must be issued to transfer CII
Rx Translations
Must provide at pt request - Printed on rx container, label, or on supp doc - If translated sig is on rx container or label, the English sig version must also be on container or label whenever possible and can appear on other areas of the label outside of pt centered area. If not, provide on supp doc. - RPh can use translations made available by board - RPh not required to provide translations for use beyond languages that the board has made available in translated form
If licensed employee admits to using drugs illegally
Must report to BOP within 30 days. It is customary to suspend employee from work pending an investigation or terminated from employment. Non-licensed parties such as clerks don't have to be reported, but incident must be reported within 30 days to board of missing or stolen drugs
Pharmacy Returning CII
Must use DEA 222 acting as supplier
Ethambutol-Reduces carbohydrate polymerization of mycobacterium cell wall by blocking arabinosyltransferase. -Use: Mycobacterium tuberculosis. -Toxicity: optic neuropathy (red-green color blindness).
Myambutol 1.6g QD
2. Pyridoxine/Unisom=Benedryl=Antivert/Dramamine 3. Phenergan=Compazine=Reglan 4.Zofran, Medrol, Decadron, Deltasone
N/V in pregnancy: 1. natural products: *ginger in tea form or cooked* 2. 1st line: *Vit B6, Doxylamine=Diphenhydramine=Meclizine* 3. 2nd line: Dopa antag: *Promethazine=Prochlorperazine=Metoclopramide* 4. 3rd line: Serotonin Antagonist: *Ondansetron; Methylprednisolone, Dexamethasone, Prednisolone*(Chemo N/V>Decadron 12mgw/f+Emend 80mg+Zofran )
When can a prescription be post-dated?
NEVER! It is ILLEGAL to post date ANY prescription. HOWEVER, a prescriber can date the prescription for the date written and indicate that they do not want it filled until a later date
can you change a medication from a ointment to a cream because you're out of the ointment, if the prescriber did not specify do not substitute?
NO! different base is different from a cream and might change the rate of the drug delivery. and changing from a cream to an ointment because is in the benefit of the pharmacy not the pt
Can c2 prescriptions be filed with non-controls?
NO! it must be filed seperately
Can an out-of-state C2 written on a normal rx blank be filled by mail order in california?
NO! it must be on a CA approved security form
Emergency Supply of C2
NOT ALLOWED without an emergency order
Nicorette & Commit loz; Nico Derm, Habitrol; Nicotrol
NRTI: Nicotine gum&lozenge(2mg if <25cigs/day or 4mg if >25 cigs/d; max: 5loz/6hrs, 20loz/d, 24 gums/d); Nicotine patch(LA, 21mg/day>14mg/day>7mg/day, ok w/bupropion, remove before bedtime if insomnia); Nicotine inhaler-Rx (Max 16 car/day); nasal spray (max: 40 doses/80 sprays/day): 1. up to 12 wks tx, 2. preg-c(gum); D(rest) 3. ID to show >=18 3. Precaution: recent MI or cardiac disease
treat pain and arthritis
Nabumetone
A Valid Prescription must contain....
Name & Address of Patient Drug Name Quantity Directions for use Prescriber (License, DEA, Name, Address) Sign and Date
Stool Softeners (emollients)/ Surfactants (anionic, surface-active) (OTC) Low risk in pregnancy
Need 1-2 days. Minor S.E. Require increased fluid intake to soften stool. Minimal systemic absorption Docusate sodium (Colace) 100mg daily. Pregnancy Cat C; Docusate calcium (Kaopectate Liqui-Gel)
Internet RX
Need name or initials of person sending whether the MD or his or her designee & assurances med was ordered as result of good faith exam on the part of the MD
Akynzeo
Netupitant+Palonosetron (acute and delayed CINV)
Niacin, Niaspan ER(Rx), Niacor(OTC): max 6g/d
Nicotinic Acid, Vit B3: 1. cautions: gout, ^BG, ^myopathy or rhabdomyolysis 2. Niaspan (ER) QHS after a low-fat snack; other niacins w/f 3. few SE at 14mg (Female) or 16mg(male) QD, if >=1g>>poor tolerability d/t flushing/itching>>CL if PUD, bleeding>>take after food, ^dose gradually, take ASA 30mings prior, avoid spicy food, alcohol, showers after taking drug, take ER niaspan-better tolerated but ^hepatotoxic
Macrobid; Macrodantin 1. Dark urine 2. 100mg BID*5d take with food 3. DDI with Mg2+ 4. cause lung problem and C. diff 5. Preg-D near term
Nitrofurantoin monohydrate(treat and prevent urinary tract infections)
Nipride
Nitroprusside: most effective IV anti-HTN drug. acts in secs and disappear within min; for acute HF as NTG, nesiritide(natrecor)
Nitropress**protect from light **change color to blue>>cyanide poisoning
Nitrroprusside (lower blood pressure)
Schedule I Drugs
No accepted medical use - MDMA - Heroin - LSD - Marijuana - Peyote
Does a pharmacy require a permit to sell veterinary food-animal drugs?
No additional permits are required by the board for pharmacies
Rx Refills (Non-CS)
No exp but standard of practice is max 1 year of refills
Max amount of time a pharmacist may leave the pharmacy and leave other non-pharmacists in the pharmacy
No more than 30 min for meal or other breaks
Drug sample
No person may sell, purchase, or trade or offer to sell, purchase, or trady any drug sample. Rph can not even charge dispensing fee for preparing drug sample. Must provide at no charge
If a RX is written by a PA, NP, CNM, or Rph pursuant to MD authorized protocol, does MD name still need to be on RX label?
No, only name of PA, NP, CNM, or Rph is fine. May prescribe controlled meds pursuant to MD protocol IF registered with DEA
can a tech or clerk call for additional refills of a prescription greater than 1 year old?
No, requires a new Rx so intern or pharmacist must call
May a pharmacist dispense a controlled substance to a patient for an addiction problem?
No. a phycisian may not prescribe a control for a patient an addiction problem unless it is associated with an "Authorized Addiction Treatment Program"
Emergency Refill Limits in California
Non-Scheduled: Partial or full refill at pharmacist discretion CIII-IV: Reasonable amount to cover the emergency period until prescriber can be contacted *CII- Cannot be dispensed without the prescribers authorization. *
What is the maximum BUD for multi-‐unit containers?
Not later than (a) exp date on manufacturer's label or (b)1 year from date drug dispensed
Class III recall
Not likely to cause any serious adverse effects and does not go to the customer level
Counseling in inpatient
Not req'd to consult patient on each med while inpatient, but must provide discharge counseling of all discharge meds.
tapentadol IR tablet **avoid alcohol **CII
Nucynta (Narcotic It can treat severe pain) MedGuide
Armodafinil; modafinil C-IV excessive daytime sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work disorder. It is commonly used off-label to treat attention deficit hyperactivity disorder, chronic fatigue syndrome, and major depressive disorder. 1. risk of rash>MedGuide
Nuvigial; provigil
Nystop/Mycostatin=clotrimazole loz(Mycelex)=oral fluconazole or itraconazole
Nystatin: oral yeast infection; Rx only;
Partial Fills CIII-CV
OK as many times pt wants, just document and make sure refills valid
Returning Drugs to Pharmacy
OK but do NOT return to stock or dispense to another pt
Partial Fills CII
OK if - Insufficient stock (72 hours deadline for remaining balance to be filled) - Emergency oral rx (72 hours) - Requested by pt or prescriber (30 days) - Terminally ill pts (60 days) - LTCF residents (60 days) *Note reason for partial fill on rx
Pharmacies Donating Drugs
OK if rx drugs in single use or sealed packaging from SNF, home healthcare, board and care, or mail order - No CS - Must be unused/unexpired - In unopened, tamper resistant packaging or modified unit dose containers with lot numbers and expiration dates - Not adulterated/misbranded - Drugs that need refrigeration must be stored, packaged, transported at appropriate temps - Received directly from manufacturer or wholesaler - Returned from health facility to which drugs were originally issues - Never in possession of pt or member of the public
US Territory Prescribers
OK to fill Territories: Puerto Rico, Virgin Islands, Guam, American Samoa
Pharmacy Returning CIII-V
OK to return drugs to supplier if Maintain written record showing - Date of transaction - Name, strength, dosage form, qty of CS - Supplier or manufacturer's name, address, registration number
E-Prescribed Controlled Rx's
OK with DEA approved software Needs 2 of the following for authentification - Something you know (password, etc.) - Something you have (hard token, etc.) - Something you are (fingerprint, etc.) OR can use digital certificate
Compounding ahead of time
ONLY allowed if a limited quantity of compounded product in advance if that quantity is necessary to ensure continuity of care for an identified population of patients based on documented history. Not more than 72 hr supply for office use.
Avreva; Zovirax=Valtrex=Denavir=Famvir
OTC*Docosanol* (5x/day, max 10ds) Rx: *Acyclovir=Valacyclovir=Penciclovir=Famciclovir*: 1. HSV-1(oropharyngeal: cold sores or fever blisters) HSV-2 (genital) 2. at the 1st sign of an outbreak within the 1st day 3. PO: 200mg 2-5/day(drink water PPX kidney stone); cream: 6t/day for 7 D 4. if resistant to all>>Foscarnet(IV only) 5. renal toxicity
Converting 30DS to 90DS
Okay if - Pt completed initial 30DS with no negative effects or pt previously received same med with 90DS - Total qty dispensed (incl refills) does NOT exceed amount auth'ed on rx - RPh notifies MD of increase in number of DS dispensed Do NOT convert if - CS or psychiatric drugs - MD indicates no change in qty - MD indicates initial amount is medically necessary
Switching Formulations
Okay if selecting a different formulation with the same active ingredients of equivalent strength and duration of therapy IF the change will improve pt compliance
Prescriber's Office Purchasing Compounded Meds
Okayto sell compounded preps to MDs for admin or application to pts (human and animal) in the office if - Purchase order or other doc sent to pharmacy that lists the pts needing the preps and qty needed for each pt should be specified NOT okay for MD to purchase compounded preps from pharmacies to furnish/dispense to human pts *Vets can do this up to 120hr supply
Nasal: Patanase, Ophthalmic:pataday, patanol
Olopatadine(Nasal Inhaler, Ophthalmic) eye itching caused by pink eye (allergic conjunctivitis)
Monoclonal Ab (-) IgE
Omalizumab (Xolair)
Omalizumab
Omalizumab (Xolair)
Lovaza
Omega-3-acid ethyl esters: use when TG>=500mg and cannot achieve adequate control with niacin or fibrates
On site storage requirements
On site also includes a building/storage area directly attached to the premises (or the same address).
Schedule V-III Drugs can be transferred...
Once
How may times may a schedule III, IV, & V controlled substance be transferred to another pharmacy?
One time
Blister packs can be made for patients but no more than...
One-month can be dispensed at a time.
Rx Transfers (Non-CS)
Only between pharmacists/interns as many times as there are refills Each pharmacy must include - Pharm/intern identification involved in transfer - Both pharmacies' name/ID/address - Original date and last dispensing date - Number of refills and date originally authorized - Number of refills transferred (remaining refills not dispensed)
Faxed CII
Only if pt in SNF, intermediate care facility, home health, or hospice
PRN refills allowed on what?
Only non-controlled.
If ADS is stocked at a facility who can do it?
Only the Pharmacist
Who can sign the 222?
Only the person who signed registration or whoever has power of attorney
Who can make the offer to counsel in California?
Only the pharmacist or Intern
oxymorphone
Opana
Oxymorphone CII
Opana **avoid alcohol and empty stomach
When to make changes to Medicare Advantage Star Plans
Open Enrollment Period, which runs October 15 to December 7 -Change from Medicare Parts A & B (Original Medicare) to a Part C (private Medicare Advantage) plan -Change from Medicare Advantage back to Original Medicare -Join, drop or switch a Part D prescription drug plan -Switch Medicare Advantage plans
1. Belbuca(Bucal film), Butrans(patch, flush or unite package), buprenex(IV), probuphine implant kit, sublocade(ER)=Suboxone 2. Stadol 3. Nubain 4. Talwin
Opioid Agonists: 1. *Buprenorphine* CIII, MedGuide, REMS; Prescriber need DATA 2000 waiver with DEA starts with X; decrease dose for chronic pain and ^dose to treat addiction; BBW butran: max one 20mcg/hr patch. Risk of QT prolongation. wear 1 patch for 7 days *+naloxone* methadone alternative used daily for addiction 2. *Butorphanol* C-IV, pain in labor/anesthesia/nasal spray for migraines 3. *Nalbuphine* pain in labor /anesthesia 4. *Pentazocine* C-IV
1. Narcan/Suboxone=Bunavail=Zubsolv 2. Revex 3. Vivitrol 4. Relistor
Opioid Antagonists: 1. *Naloxone/+Buprenorphine* 0.4mg-2mg q2-3min or IV infusion. causes an withdrawal syn in pt physically dependent on opioids 2. *Nalmefene* 3.*Naltrexone* for alcohol and opioid dependence; MedGuide 4. *Methylnaltrexone* opioid induced constipation Buprenorphine and naloxone CIII
DEA 222
Ordering schedule I and II drugs 1. Brown, supplier keeps (sends green) 2. Green, supplier sends to DEA 3. Blue, receiver keeps (sends other two copies) *Not required if drugs transferred from central fill to retail pharmacy **Can initially be ordered off DEA 224 and reordered via DEA website or calling ***Keep records for at least 3 years
Xenical, Alli(OTC) lipase inhibitor take with meal or 1 hr after meal; >=12; vitamin ADEK, seperate with cyclospotine and levothroxone
Orlistat
Schedule III xyrem is a central nervous system depressant used for the treatment of cataplexy and extreme daytime sleepiness (EDS) associated with narcolepsy. It is the sodium salt of gamma hydroxybutyric acid (GHB) which is an endogenous compound and a metabolite of the neurotransmitter GABA
Oxybate CIII
Cogentin=Artane; Symmetrel; Eldepryl=Azilect
PK 1. Anticholinergics: Benztropine=Trihexyphenidyl: Anticholinergics for initial treatment of tremors; start QHS, confusion, dry mouth, constipation, urinary retention, tachycardia, blurred vision>>not for elderly ; 2. Amantadine ((-) DA reuptake; dyskinesias in advanced disease; antiviral-influenza drug); 3. MAO BI: Selegiline=Rasagiline (mild benefit as initial tx, used as monotherapy or adjunctive with levodopa)
Power of Attorney
POA is written authorization permitting the other staff members who can be licensed or unlicensed to order CS on behalf of registrant - Can be revoked at any time - Multiple POAs okay - Readily retrievable and filed with DEA 222s - No official form but board recommends the following
Viekira Pak, Viekira XR **all ritonavir cause photosensitivity
Paritaorevir+Ritonavir+Ombitasvir+Dasabuvir (HCV) 2 PRO AM+1D BID w/f; 12wks for genotype 1
Technivie**(ritonavir solution refrigerater, capsule RT for 30D)
Paritaprevir+Ritonavir+Ombitasvir(HCV)
Tegretol/Carbatrol/Epitol/Equetro (for bipolar)=Trileptal/Oxtellar XR=Lamictal=Keppra/spritam(rapidly disintegrating)=>Dilantin-125/Phenytek/Dilantin Infatabs=>Cerebyx=>Depakene/Stavzor=Depakote=>Topamax=>Zonegran=>Lyrica=>Neurotin
Partial Seizure: *Carbamazepine*(400-1600mg/d. Range 4-12mcg/ml. Monitor: LFTs, CBC, plates, BBW: serious skin rxs, aplastic anemia&agranulocytosis, (-)OC) *=Oxcarbazepine*(300-600mgBID. monitor Na+, BBW: -OC, skin rash, hyponatrmia)*Lamotrigine*(Max400mg/d, only preg-C, BBW: skin rash, aseptic meningitis, insomnia)*=Levetiracetam*(500-1500mg BID, BBW: wt loss, no significat DDI)*=>Phenytoin*(NS only+filter+max 50mg/min+no refrigerator/short stability+saturable>^dose can^^levels)*=>Fosphenytoin*(prodrug, should not>150mg PE/min, 1mgPE=1mgPHT, IM and NS/D5W ok):100mg TID, range 10-20mcg/ml ok, IV to oral ratio 1:1, BBW:Teratogenicity, -OC, skin rash, supplement with folic acid, Ca and Vit D *=>Valproate/Valproic acid=Divalproex*(45mg/kg/d, range 50-100mcg/ml, monitor:LFTs, CBC, platelets, Do not break the caps, because they may hurt your throat. take with food., BBW: teratogenicity, fatal pacreatitis, Wt gain, alopecia)*=>Topiramate*(200mg BID Cl if sulfa allergy, SE: wt. loss, kidney stones, oligohydrosis)*=>Zonisamide*(CL if sulfa allergy, SE: wt loss, kidney stoes, oligohydrosis)*=>Pregabalin*(C-V, up to 300mg/d, caution if renal failure. slight euphoria, wt gain)*=>Gabapentin*(caution if renal failure): all need MedGuide for suicidality, all have additive sedative/dizziness/confusion SE>avoid use of other CNS depressants, Avoid St. John's Wort and evening primrose, ^DDI for more than one agents
What is not a legal requirement of pharmacy techs?
Pass an exam administered by BOP in order to be granted pharmacy tech certification
Bicilin L-A(IM only once); Bicillin C-R(IM only); Pfizerpen-G (IV)
Penicillin G benzathine; Pen G Benzathine+Procaine; Pen G Aqueous
Refrigerated antibiotic suspensions
Penicillin V Vantin (cefpodoxime) Ceftin (cefuroxime) Benzamycin Erythromycin/sulfisoxazole (Pediazole) Amoxicillin Keflex (PVC BEAK)
Pen-Vee K; Veetids(oral; empty stomach)
Penicillin VK
Who can receive oral rx?
Pharmacist, pharmacy intern
Who can transfer in Cali?
Pharmacists and Interns
Who do not need to consult CURES before each new CS rx?
Pharmacists and vets - RPh already do more than anyone!
Change of PIC
Pharmacy and departing PIC reports to BOP within 30 days
If patient request price for > 5 rx & no valid rx
Pharmacy may request that price request is in writing & prices can be given in 10 days; may charge fee for EACH prescription price quote but inform patient first; NOT required to respond to > 3 requests for a single person in 6 mo period; CS telephone requests don't have to honor; do not have to respond to competitor, do not have to respond to out of state requester
Information on RX prices
Pharmacy must place BOP notice to consumers of the availability of RX price info. Pharmacy shall give current retail price for any drug sold if requested.
Definition of a pharmacy being Closed down
Pharmacy no longer engaged in activity it was licensed for, or not operating at least 1 day per wk in a 120 day period
Pyridium, AZO, Uristat
Phenazopyridine Hcl: 1. urinary analgesic for s/sx okay for preg 2. Rx 200 TID, OTC 100*2d; 3. red/orange urine coloring 4. cranberry uice may only prevent a UTI but dose not treat a UTI
CIII stimulant (Bontril)
Phendimetrazine
C-IV **1. pregnancy 2. birth control less effective (All barburates) Cytochrome P450 inducer
Phenobarbital
Stimulant: Fastin, Adipex(no pregnancy), lomaira Suprenza Decrease appetite, weight loss***avoid in HTN, PAH, hyperthyroidism, glaucoma, QAM
Phentermine Hcl C-IV
Bentoquatam=XX=Burrow's=Aveeno=Caladryl
Pioson Ivy: *Ivy Block=Zanfel=Aluminium sol.=colloidal oatmeal=calamine*
Zosyn
Piperacillin/tazobactam: cover PSA; renal toxicity; Preg B;-birth control
May cause blurred vision
Plaquenil PDE 5 inhibitors INH Isotretinoin Ethambutol Scopolamine patch VFEND Amiodarone Anticholinergics Tamoxifen Ketek (PPIIESVAAT K)
Anti-parasite It can treat malariaUses = tx hepatic forms of P. vivax and P. ovale Don't give in pregnancy (-->fetal hemolytic anemia screen for G6PD deficiency)
Primaquine
nifedipine ER brand?
Procardia XL
Prometrium **peanut or soy allergy
Progestrone
Zoladex=Zytiga=Casodex=Eulexin=Lupron
Prostate Cancer: *Goserelin* (prostate and breast cancer)=*Abiraterone*=*Bicalutamide*=*Flutamide*=*Leuprolide*
Prezista=Lexiva=Agenerase=Aptivus; Viracept=Invirase=Reyataz=Norvir PI
Protease Inhibitor for HIV -navir: Darunavir=Fosamprenavir=Amprenavir=Tipranavir(sulfa); Nelfinavir=Saquinavir=Atazanavir=Ritonavir(w/f): 1. SE: hyperglicemia, hyperlipidemia(DDI with CYP450: pravastatin, fluvastatin,rosuvastatin) 2. Ritonavir: take with food; cap RT*30D, do not chew, break or crush; +lopinavir(kaletra) only solution refrigerater+RT*60 D
Olysio=Victerlis
Protease Inhibitors for HCV: Simeprevir=Boceprevir: 12-48 wks, genotype-1, combo with ribavirin+IFN, SE. anemia requiring ESA use, photosensitivity for simeprevir
Which HIV drug class has the most significant risk of contributing to death due to cardiovascular complications?
Protease inhibitors because they elevate glucose and lipid panels.
Combat Methamphetamine Epidemic Act of 2005
Pseudoephedrine/ephedrine/phenylpropanolamine. Must be behind the counter or locked in cabinet. Record keeping: name of purchaser, address, date & time of saline, amount of product sold. Maintain for 2 yrs. 3.6 g/day per individual or 9 g/mo, no more than 7.5 g can be imported. Sold in blister packs. Report loss/theft within 15 days in writing, also report orally to local DEA. Exception: single purchase of 1 60 mg pseudoephedrine unit dose package or a unit dose package containing 2-30 mg tabs = no log entry required
2. XX=Dovonex/Taclonex oitment; enstilar foam=Tazorac=Anthranol/Psoriatec 3. Neoral/Sandimmune=Soriatane
Psoriasis: 1. OTC: *Coal Tar shampoo* 2. Rx: Topical steroids*Triamcinolone and betamethasone*, *=Calcipotriene/+betamethsasone*(comb, do not use>4wks or>100g weekly)*=Tazarotene=Anthralin* 3. Oral Rx: *Cyclosporine=Acitretin*(BBW: teratogen>MedGuide, sign consent) *=Methotrexate*
Metamucil
Psyllium
DIARRHEA
Psyllium (Metamucil) to soak up liquid Loperamide (Imodium) Start 4mg, followed by 2mg after each loose stool (max 16mg/d) Lomotil (diphenoxylate + atropine) C.V 1-2 tab QIDAC Bismuth Subsalicylate (Pepto-Bismol, Kaopectate) 2 chew tabs q30min- Avoid if salicylate allergy! Black tongue & stools Also treats indigestion, stomach ulcers © 2017 Grifoll |41 | P a g e Inflammatory Bowel Disease Crohn's disease and ulcerative colitis Antidiarrheal medicines (loperamide) Alosetron (Lotronex) can help women who have diarrhea as the main symptom. REMS program. Antispasmodics (anticholinergics). S.E.: dry mouth, urinary retention, tachycardia, dry/blurry vision, etc. Dicyclomine (Bentyl) 10mg AC and QH Hyoscyamine Donnatal= phenobarbital + belladonna alkaloids (atropine, hyoscyamine, scopolamine)
Fiber/Bulk forming (OTC) 1st line
Psyllium (Metamucil), Methylcellulose (Citrucel), Polycarbophil (FiberCon), Prunes Take with plenty of water! (risk of choking with powder form), take 2hr before/ after other drugs Safe in pregnancy but take days to work & cause bloating- Ok for regular maintenance
Maintain x at least 6 yrs
Pt acknowledgement of HIPAA
Maintain x at least 1 yr
Pt med profile Med error/QA reports
How often are laminar air hoods and clean room certified? (sterile compounding)
Q6mo (updated info for 2018)
Beclomethasone
QVAR nasal;Beconase AQ
Phentermine and Topiramate Extended-Release
Qsymia
Phentermine and Topiramate extended-release: Wt loss; severe birth defects>>REMS; topiramate and all anticonvulsants birth control less effective; anxiety, depression, suicidal thought, tachycardia
Qsymia C-IV
Medicare 5 Star Rating System
Quality measures include - Annual CMR for pts in MTM program - Adherence to non-insulin DM meds, statins, renin angiotensin system antagonists - Appropriate use/avoidance of high risk meds in pts 65+ - Statin use in DM pts 40-75YO
Who can transfer rx?
RPh and intern
Who can restock ADD *in the facility*?
RPh only.
If RPh license is not renewed in 3 years following license renewal....
RPh will have to retake and pass licensing exams.
Ranexa
Ranolazine: add-on therapy to decrease number attack, for angina, decrease O2 demand, no effects on HR or BP; SE:dizziness, constipation, QT prolongation; other add-ons ACEI if pt is at risk for HF, flu vaccine and statin
Class I Recall
Reasonable probability use/exposure will cause serious ADR or death RPh notifies MD and keep record MD may or may not notify pt
Class I recall
Recall class where there is a reasonable possibility that the use/exposure to a violative product will cause serous adverse effects on health or death
DEA 41
Record of controlled substances destroyed *DEA registered reverse distributor who destroyed CS is responsible for completing
Form 41:
Record of controlled substances destroyed.
Remotely Operated ADDS
Registered ADDS with board w/in 30 days of installing and annually as part of license renewal - Inform board if ADDS discontinued *Do not need to register if ADDS is operated within facility
Form 363:
Registration for narcotic treatment. A 3 helping a 3.
Form 225:
Registration for: Manufacturer Distributor
Form 224:
Registration for: Retail Hospital or clinic teaching practitioner mid-level practitioner
DEA 225
Registration form for manufacturers, distributors, researchers, analytical laboratories, importers, exporters
DEA 363
Registration form for narcotic treatment programs
DEA 224
Registration form for retai pharmacies, hospitals/clinics, practitioners, teaching institutions, or mid-level practitioners
CII
Registration is required. Receiving records = DEA form 222. Written RX. No refills. Separate filing. Distribution between registrants require DEA form 222. Locked cabinet or dispersed among noncontrols. Report to DEA in 1 business day & complete DEA form 106. Maintain all records for 2 years unless state law requires longer
CV
Registration is required. Receiving records = invoices that are readily retrievable. Written, oral, fax. As authorized when rx is issued or if renewed by physician. Separate filing or readily retrievable. Distribution between registrants require invoices. Locked cabinet or dispersed among noncontrols. Report to DEA in 1 business day & complete DEA form 106. Maintain all records for 2 years unless state law requires longer
CIII-IV
Registration is required. Receiving records = invoices that are readily retrievable. Written, oral, fax. No more than 5 refills within 6 mo. Separate filing or readily retrievable. Distribution between registrants require invoices. Locked cabinet or dispersed among noncontrols. Report to DEA in 1 business day & complete DEA form 106. Maintain all records for 2 years unless state law requires longer
DEA 41
Report any destruction of a CII (planned disposal or accidental breakage/spillage.
Reporting time if outsourcing facility made aware pt has been harmed using compounded product prepared y facility
Report to FDA MedWatch w/in 15 calendar days
Reporting time if pharmacy made aware pt has been harmed using compounded product prepared by the pharmacy
Report to FDA MedWatch w/in 72hrs
Licensed individual engaged in theft or diversion or self use of rx drugs belonging to pharmacy
Report to board w/in 14 days
Licensed individual is known to be chemically, mentally, or physically impaired so that it affects ability to practice
Report to board w/in 14 days
Suspected pharmacist impaired at work?
Report to board w/in 14 days
Responsibility of Wholesaler or Manufacturer in terms of sales of dangerous drugs
Report unusual or larger than normal sales to pharmacist of dangerous drugs that: - exceed 20% increase when compared to last 12 month period must report to Board within 30 days of findings
DEA 106
Reporting the theft or significant loss of controlled substances
Form 106:
Reporting theft or significant loss of controlled substance.
Patient package insert
Required for all drugs containing estrogenic agent
Technician Trainee
Required to compete externship as part of program to become technician Can perform all tech duties under RPh supervision
HCV: Rebetol, copegus, moderiba, ribasphere, ribasphere ribapak; RSV: Virazole must comb
Ribavirin: **avoid pregnancy(6m after)+R:renal+I: incombo+ B: baby+A: hemolytic anemia(BBW)
Rifadin TB **1. orange urine/body fluid 2. P-450 inducer: birth control less effective 3. no RICE with RI; empty stomach 4. Flu-like syndrome
Rifampin: alternative: rifabutin
Priftin **birth control less effective Anti-Tuberculosis; Rifamycin; binds to DNA dependent RNA polymerase, which now can't make mRNA, and leads to bactericidal activity. Decreased protein synthesis.
Rifapentine
Xifaxan>>HE in cirrhosis
Rifaximin
Right to Refuse
Right to refuse to dispense based on religious, moral, ethical beliefs - Must notify employer in writing - Establish written protocols so pt can still access med in timely manner
Risperidal PO(mix no cola or tea), Risperidal consta (IM Q2m)
Risperidone
norvir: HIV take with food
Ritonavir
Neupro(patch)
Rotigotine (a dopamine agonist of the non-ergoline class of medications indicated for the treatment of Parkinson's disease and restless legs syndrome.)
Deceased Prescribers
Rx's still valid (all other rules for valid rx's still apply) RPh should encourage pt to look for new MD
CI in GFR < 30
SGLT2 inhibitors Metformin
Entresto
Sacubitril-Valsartan: neprilysin inhibitor+ARB to reduce the risk of CV death and hospitalization for CHF and reduced EF
Xadago (Parkinson's disease during "off" episodes)
Safinamide
Single Codeine tablet
Schedule II But a combo product containing 1.8 g/ 100mL is schedule V.
transderm-scop
Scopolamine: **apply 4 hrs before need, Q3days, (anticholinergic)>sedating, exacerbate serizures, not with glaucoma,cause mydriasis(dilation), acute psychosis in frail elderly
DEA 363
Separate DEA registration as a Narcotic Treatment Program. Must request to be a DATA waved practitioner. May treat 30-100 patients at a time. Has unique ID number beyond DEA number
Drug Storage for Investigational New Drugs
Separate from other drug stock
Drug Storage for Recalled Drugs
Separate from other drug stock - Class I - Class II - Class III
Drug Storage for Repackaged/Resold Drugs
Separate from other drug stock, assigned BUD
Rx Transfers (CIII-CV)
Similar to non-CS except can be transferred only ONCE and needs pharmacy DEA to document *Can transfer an unlimited number of time between pharmacies under same real-time updated database (Rite Aid)
Filter
Simponi Lipids Ativan Amiodarone Amphotericin B PN Dilantin (SLAAAPD)
carisoprodol
Soma) C.IV
Betapace, Sotylize,sorine
Sotalol (Antiarrhythmic)
Aldactone, carospir=inspar: Aldosterone antagonists
Spironolactone(with food)=eplerenone: BBW tumorigenic, gynecomastia, menstrual Rx, used for HF, CI in pregnancy, metabolic acidosis
Medication error investigation, start investigation.... How long to keep record of the QA review Who should RPh notify?
Start within 2 business days from the date the error was discovered. 1 year from date created. RPh to notify patient and prescriber.
A pharmacy may order CII from out-of-state wholesaler, manufacturer, or other supplier as long as pharmacy forwards a true & correct copy of the order, contract, or agreement for procurement of such a CII drug to who & within what time period
State's Attorney General's office within 24 hours of transmitting order
Transaction history
Statement including transaction info for each prior transaction going back to manufacturer of the product
Stimulants/ irritants (OTC)
Steady intestinal contractions. Use overnight, bowel mov. next morning. Create habit. Occasional use only Caution if bone disorder as it can affect vitamin D and calcium absorption Bisacodyl (Dulcolax). Do not crush EC tabs; Senna (Senokot, Ex-lax) 8.6 mg tab BID. Preg cat. C; Castor oil
Verify DEA #
Step 1: add 1st, 3rd, & 5th digits together Step 2: add 2nd, 4th, & 6th digits together Step 3: multiply the result of step 2 by two Step 4: add the results of step 1 and step 3 together. The last digit of this sum should match the last digit of the prescriber's DEA #
Elvitegravir/cobicistat/emtricitabine/tenofovir; HIV take with food
Stribild
CI in CrCl < 50
Stribild Vfend
PIC Liability
Strict liability for violation of law in pharmacy with or without knowledge of violation
Quinupristin/Dafopristin: 1. Gram+, MRSA, VRE 2. D5W only, must be >=250ml for IV 3. renal okay 4. SE: hyperbilirubinemia, phlebitis, myaslgias 5. 3A4 inhibitor
Synercid
Compounding by California Law standards *does not include*
Tablet Splitting Tablet Crushing Capsule opening Adding flavoring agents.
Prograf, Astragraf XL: oral: cap., and e.r. cap., used to prevent transplant rejection, calcineurin inhibitor **avoid grape juice and food, photosensitivity+++Protopic(eczema) medguide**non-PVC
Tacrolimus
Non-PVC containers
Tacrolimus Insulin NTG Ativan Amiodarone
PRN Refills:
Take note of the days supply. You can only refill the medication up to one year and the original fill doesn't count towards refills.
Soltamox (SERM); cause blurred vision
Tamoxifen (treat breast cancer. It may also prevent breast cancer in women at high risk of developing it)
Telepharmacy - remote site can: 1. Accept delivery of meds (CS must be stored until RPh can review and countersign) MUST use barcode technology
Telepharamcy CANNOT: 1. accept new rx orally, compound, perform any task requiring professional judgment .
Ketek; cause blurred vision**avoid grape juice
Telithromycin; BBW: not for myastenia gravis(respiratory failure)+MedGuide; CL:allergy to macrolides; Preg-C
Viread N:nephrotoxicity+O: osteoporosis+F: Fanconi syndrome
Tenofovir Disoproxil fumarate
Viread
Tenofovir+Disoproxil+Fumarate(TDF, HBV, HIV)
Your license expires...
The last day of the month of your birth.
Class II recall
The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency
Rx Label Requirements
These four items must be written in the following order in *12 point sans serif on the label consuming 50% of the sticker* (Must be highlighted or in grey out area of the label nothing else can be in here) Name Drug (Manu-Generic, or trade) + Strength Directions for use Condition if on the Rx.
If a pharmacy address changes what happens with the 222?
They have to be canceled and sent back to the nearest DEA for new forms.
Bebulin, profilnine(the prevention and control of hemorrhagic episodes in hemophilia B patients)
Three factor prothrombin complex
Brilinta
Ticagrelor (prevent stroke, heart attack, and other heart problems)
ticarcillin/clavulanate: PSA; -birth control; renal toxicity; preg B
Timentin
Report left/theft of CS drugs by
To DEA immediately (1 business day) To BOP w/in 30 days
Within how many days must the board be notified in the case of a bankruptcy, insolvency, or receivership?
To be reported immediately in writing
Notice to Consumers
To make sure consumers understand their rights, including - Counseling - Type of info that should be provided - Can ask questions Notice advises pt that easy to read type and interpretive services are available on request Full size poster of Notice to Consumers must be posted in public view OR written receipts containing required info can be provided to pts - Can also display ppt photo on viewscreen
1. Clobex/Cormax/Olux/Temovate=Vanos Cream/Lidex=Topicort=Psorcon=Ultravate 2. Elocon=Kenalog=Cultivate=DermAtop 3. Hytone=DesOwen>>Atarax
Topical steroids: 1. high: *Clobetasol 0.05%=Fluocinonide 0.05-0.1%=Desoximetasone 0.05-0.25%=Fiflorasone 0.05%=Halobetasol 0.05%* 2. Medium: *Mometasone 0.1%=Triamcinolone 0.1%=Fluticasone 0.005%=Prednicarbate 0.1%* 3. Low: *Hydrocortisone 0.5-2.5%=Desonide 0.05%*: DOC inflammation, Rash>*hydroxyzine* (25mg TID-QID, for urticaria)
Camptosar=VePesid/Etopophos/Toposar=Hycamtin
Topoisomerase ihibitors: *Irinotecan**=Etoposide*(refregirate; treat testicular cancer, lung cancer, lymphomas, nonlymphocytic leukemia, and other kinds of cancer)*=Topotecan*
Demadex Loop Diuretic
Torsemide
Ultram, Ultracet(+APAP), ConZip ER **avoid alcohol
Tramadol HCl C-IV: seizure and serotonin syndrome risk
Disposal of controlled substances
Transfer to DEA registered reverse distributor (contact local DEA for listings). Reverse distributor needs to issue a Form 222. Reverse distributor should issue form 41 for the destruction of controlled substances
You also need a 222 for..
Transfers as well as purchases, destruction. Anywhere a CII goes except from when a central fill pharmacy sends to a satelite.
Oleptro, Desyrel (depression)=Serzone
Trazodone=Nefazodone: 100mg HS caution: sexual dysfunction, priapism
Fax of RX from one pharmacy to another pharmacy
Treat fax like telephonic order. Create a written RX identify it as a transferred RX & attach faxed copy as reference
Atralin, Renova, Retin-A, avita**photosensitivity +QHS+take 4-12 weeks and worsen acne initially
Tretinoin(Topical)
Dyazide, Maxzide=Dyrenium=Midamor: K-sparing
Triamterene/Hydrochlorothiazide=triamterene=amiloride: metabolic acidosis(increase K, decrease ca, gout, CI if <30, BBW: Hyperkalemia)
Nebulizer- Mouthpiece or mask I.e. Albuterol sol. (AccuNeb)
Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir. Connect the nebulizer to the mouthpiece or face mask. Connect the nebulizer to the compressor. Place the mouthpiece in your mouth or put on the face mask; and turn on the compressor. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5-15 minutes).
Time period in which to electronically send in info on schedule II, III, & IV rxs per the CURES program
Under CURES (Controlled Substance Utilization Review and Evaluation System) program must be sent weekly
Travel Meds Requirements to Furnish
Under SB493, for conditions self-diagnosable, self-treatable, or prophylaxis - RPh completes immunization cert program - RPh completes travel med training program (at least 10hrs) - RPh completes CDC's yellow fever vax course - RPh has BLS - RPh completes 2hrs CE every 2yrs - Provide good faith eval and notify pt's PCP of drugs dispensed w/in 14days or enter info in shared system - Provide pt written record of drugs provided
Within 30 days of giving a vaccine a pharmacist must
Update the patient's provider or any state/national immunization data bases.
Vistogard
Uridine triacetate (antidote to fluorouracilor capecitabine/xeloda)
Ditropan XL(OROS)/Oxytrol (patch)/Gelnique(gel)=Detrol=VESIcare=Enablex=Myrbetriq=Toviaz=Sanctura
Urinary Incontinence/overactive bladder: Anticholinergic/Muscarinic *Oxybutynin*(OTC for women, Gelnique gel 10%, patch is 2x/wk, no need to remove during MRI) *=Tolterodine=Solifenacin=Darifenacin=Mirabegron=Fesoterodine=Trospium*(BID on empty stomach)
DEA 222
Use anytime a CII is ordered, distributed, transferred. Each book has 7 forms. Max of 6 books supplied at a time. 1st copy is the wholesaler, 2nd is DEA, 3rd = pharmacy. Loss of forms must be immediately reported to DEA providing serial numbers. Copy 1 (Brown) Supplier. Copy 2 (Green) DEA (submitted by the supplier to St. Louis DEA Field Division). Copy 3 (Blue) Purchaser or registration holder.
Class III Recall
Use/exposure not likely to cause ADR - Coloring off
Time period a schedule III or IV prescription must be filled or refilled before it is void
Usually within 6 months from date written. Total supply received (NOT per refill) shall not to exceed 120 days supply of medication in 6 mo period AND refills shall NOT exceed 5 times in a 6 month period
1. Polio 2. Rotarix=Rotateq 3. Pediarix 4. Pentacel 5. Kinrix=Quadrace 6. Combax
Vaccines: 1. *Polio*(IM/SC, Cl if allergy to neomycin or polymyxin B);2. *Rotavirus Oral*;3. *DTaP-HepB-Polio IM*; 4. *DTaP-Polio/Hib IM* 5. *DTaP-Polio IM* 6. *Hib-Hep IM*
Monitor Peak (<=40; 2-3 hrs for vanco) and trough (<10); nephro/oto(do not use with similar agents such as AMGs, amphotericin); rates>15 mg/ml>>red man syndrome; preg C
Vancomycin (po for C. diff, IV for MRSA)
Effexor XR
Venlafaxine Hcl ER
Effexor
Venlafaxine Hcl IR
Doxycycline; Minocycline; Tetracycline; Tigecycline(IV only): 1. photosensitivity 2. no dairy, antacid or iron within 1 hour; w/f&w+30 mins 3. birth control less effective 4. CI: <=8yr d/t tooth discoloration; preg-D 5. atypical, rickettsial, VRE, anthrax, syphilis, MRSA, skin&urinary infection
Vibramycin/Doryx; Minocin/Dynacin/Solodyn(for acnes >=12 Yr, dose by wt); Sumycin; Tygacil
If a vet writes a prescription for an animal they must include..
What kind of animal the name and address of the owner or person having custody of the animal.
Notify the board of any theft of deposited drugs in drug take-back services
Within 14 days
If no security rx for a c2 was sent to by the prescriber, what time period does the pharmacy have to notify the DEA
Within 144 (6 days) after the 7th day of the emergency oral order
Begin med error investigation
Within 2 days of error
Notify CABOP of change of PIC.
Within 30 days.
Notify CABOP of change of pharmacist address or name.
Within 30 days.
Notify CABOP of changes in the pharmacy permit.
Within 30 days.
Period of time rx records must be produced from an off-site storage facility when requested
Within 48 hours
Period of time PIC must do investigation & report once a medication error is discovered
Within 48 hours of discovery error
DATA Waived Practitioner
X in front of DEA, replaces first letter - This and regular DEA should be on prescription Can manage 30pts at first, then increase after getting waiver after managing max pts for at least a year *Practitioner without DATA waiver can administer a day's worth of tx at one time to pt while proper referral is arranged. Can be done up to 3 days.
Rivaroxaban=Edoxaban=Apixaban: no monitoring; reverse by Kcentra IV(prothrombin complex) or FFP 15 ml/kg; renal adjust; nonvalvular AFib, DVT, PE and stroke for savaysa and Eliquis; doses>=15mg with food(10 mg can be taken without regard to meals)
Xarelto=Savaysa=Eliquis: oral Factor Xa inhibitor; anticoagulation
Pyrimidines: *Capecitabine*pro-drug of 5-fu; take with food or hour after eating*=5-fluorouracil**=Cytarabine**=Gencitabine*
Xeloda=Adrucil/Carac/Efudex=Cytosar-U=Gemzar
Oxybate
Xyrem (sudden muscle weakness and excessive daytime sleepiness) CIII
May pharmacy furnish rx for home health agencies and hospice?
YES with the exception of controls - parenteral therapy allowed but must be in portable container drugs for emergency tx must ensure: - portable container is furnished by rph - container is sealed with tamper proof seal - label on outside with contents - must be maintained by rph, nurse, or delivery persons when not in pharmacy - once seal broken, container must be returned within 7 days to be inspected/restocked/resealed - if not used within 60 days, return sealed container for verification of qty, integrity and expiration
Can a pharmacist change the dosing form of a medication without the prescriber's authorization?
YES! it must have the equivalent active ingredient, strength, and duration effect. unless prescriber indicates no substitution allowed IF it is in the patient's best interest the change must be communicated to the prescriber e.g.: capsule to tablet, or tablet to oral liquid
Do other retailers (other than pharmacies) require any special to sell veterinary food-animal drugs?
YES! requirements must be meet registration requirements: - a "veterinary retailer exemptee" or "designated representative" or "representative-in-charge" - application with Board of Pharmacy - registrant must have a high school degree or possess equivalent education - registrant must have 1+ year of paid work experience related to distribution or dispensing of ganergerous drugs - must complete training course approved by board - vet shall fill rx for food-producing animals - if vet retailer exemptee dispenses rx for controls, vet must countersign the rx before dispensing - vets may only refill up to 6 months - if unable to dispense full quantity, partial fill must be completed in 30 days. - if employee leaves, retailer shall *immediately* return certificate of exemption to board
Can a prescriber issue multiple orders for the same c2 on the same day?
YES, a prescriber can write multiple prescriptions for the same c2 if they write "do not fill before given day" as long as the total amount DOES NOT EXCEED A 90 DAY SUPPLY
Can c2's be written using a multiple check-off prescription blank?
YES, if it is pre-printed or written on a special security form exclusively for multiple control substances AND the number of controls ordered is noted on the prescription
Can c3-5's be written using a multiple check-off prescription blank?
YES, if it is pre-printed or written on a special security form exclusively for multiple control substances AND the number of controls ordered is noted on the prescription
Can an out-of-state c3-5 prescription be filled or refilled in California?
YES, if the prescription is: - written on a California security form OR - called in by the out-of-state provider
Can C2 rx's be called in ORALLY for SNF?
Yes! note: the address of the special facility is to be used as the address of record for the patient
Can c3-5 prescriptions be filed with non-controls?
Yes, a red C in the lower right hand corner must be placed on the controls to distinguish control prescriptions from non-controls
Can a prescription contain orders for non-controlled and controlled substances on the same paper?
Yes, but needs to be on the CA Security Form for CS
Can optometrists prescribe CII pain meds?
Yes, but only codeine or hydrocodone with another non-scheduled analgesic and for a max of 3 days with a referral to an ophthalmologist if the pain persists.
Can a c3-5 rx be filled at a CA pharmacy?
Yes, if - written on a CA security form or - called in by prescriber
Can Rph change formulation of drug (with same API of equiv strenght/duration)?
Yes, if it will improve patient compliance
Can an out-of-state c2 prescription be filled in California?
Yes, it may be filled in California, BUT must be delivered to a patient in another state - rx must still be on a California security form (this is to accommodate out-of-state mail order operations)
If a prescriber writes a c2 for a terminally ill patient on a normal rx blank but forgets to document "11159.2 exemption", can a RPh still fill the rx?
Yes, they must have personal knowledge of patient's terminal illness, and must subsequently return the rx to the prescriber for correction within 72 hours
Can I convert a 30 day supply to a 90 day supply?
Yes- Depends. Controlled Substance or psych drug? cannot convert Has the patient ever had it as a 90 day supply? Yes. can convert. Total quantity dispensed cannot be more than the amount authorized.
Can a pharmacy take delivery of dangerous drugs if pharmacy close and RPh isn't present?
Yes. But: 1. drugs must be placed in storage facility in same building as pharmacy 2. Only PIC (or designated PIC) has access to storage facility 3. Secure storage records entry 4. Pharmacy has P&P for this 5. Delivery includes document of name and amt of each dangerous drug
Can prescribers write for non-controlled/ controlled substances for family?
Yes. as long as there is a medical condition and a good faith exam was performed.
Aspirin and omeprazole
Yosprala
When you receive a 222 ordr
You fill out the right side of copy 3. and keep it for 3 years.
Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist=Sonata=Lunesta; Rozerem(MedGuide); Belsomra; OTC: Benadryl, Vistaril(short-term anxiety)=Atarax(antihistamine pruritis) & Unisom
Zolpidem (C-IV)=Zaleplon(C-IV)=Eszopiclone; Ramelteon(Melatonin receptor agonist); Suvorexant(C-IV); OTC Antihistamines:diphenhydramine, Hydroxyzine & Doxylamine(tolerace after 1-2 wks; SE. daytime hangover,anticholingergic. avoid glaucoma, acute asthma) ; natural products: St. John's wort, chamomile tea, melatoin, valerian
Ambien **avoid alcohol
Zolpidem Tartrate CIV
Order of Abatement
a request that something be taken care of or be corrected. if not corrected within reasonable period of time, a citation requiring a fine and/or sanctioins can be issued by the Board
Notice requirement by board and response to notice by licensee
after notice licensee must respond within 10 days
alfentanyl
alfenta c2
CII Alfenta; xx;xx
alfentanil sufentanil cocaine
butalbital-containing products
allzital, bupap, marten-tab, fioricet, fioricet with codeine, fiorinal, fiorinal with codeine c3
Normodyne, Trandate(IV for ischemic stroke max 300mg or Nicardipine(Cardene)) =Coreg
alpha-1 BB with vasodilation: Labetalol: take with food; 800mg BID=Carvedilol
zolpidem
ambien, ambien cr, edluar, intermezzo, zolpimist c4
When the attorney general's office weighs in on a situation that is not directly addressed by existing laws what is this called?
an OPINION to serve as a guide on the matter
How often do sterile compounding licenses need to be renewed?
annually
Sterile compounding: successfully completes practical skills training in aseptic technique and aseptic area practices. Continuing training is reassessed how often?
annually
Patient medication profile records
at least 1 yr after last filling of rx
Patient medication error documentation records
at least 1 yr from recorded date
Clinic pharmacy prescription records
at least 3 yrs after last filling of rx
Community pharmacy prescription records
at least 3 yrs after last filling of rx
Controlled substance inventory records
at least 3 yrs from taking of inventory
Pharmacy technician compliance records
at least 3 yrs from time of making
how long for patient acknowledgement of HIPPA ?
at least 6 years
How many BoP members must be present at the meetings?
at least 7
Hospital pharmacy prescription records
at least 7 yrs after last filling of rx
Hospital: when a pharmacy distributes C2 substances to another DEA registrant --> Copy 2 of Form 222 is submitted to DEA when?
at the end of each month
benzodiapzepines such as lorazepam diazepam, alprazolam
ativan, valium, xanax c4
How often are BoP meetings held?
atleast once every 4 months
suvorexant
belsomra c4
lorcaserin
belviq c4
Inderal LA, InnoPran XL=Blocadren, Timoptic for glaucoma=Visken=Corgard=Levatol=Cartrol(ocupress for glaucoma)
beta non-selective for heart and lung: Propranolol=Timolol=Pindolol=Nadolol=Penbutolol=Carteolol: Inderal LA and InnoPran XL for arrhythmia, also 10-40mg 1 hr prior to an event such as a public speech(caution: CNS effects)
Tenormin=Lopressor, Toprol=Brevibloc=Zebeta=Kerlone=Sectral=Bystolic
beta-1: cardioselective: Atenolol=metoprolol=Esmolol=Bisoprolol=Betaxolol=Acebutolol=Nebivolol(also increase notric oxide for vasodilation): Metoprolol HTN 400mg/day; HF 200mg/d; Brevibloc is only for HTN emergency and arrhythmia
what is the exception for poisonous drugs sold in pharmacies?
boric acid
brivaracetam Brivaracetam is a chemical analog of levetiracetam
briviact c5
low non HD low/medium HD less than 12 hour BUD
bud room temp 12 hours bud fridge temp 12 hours bud freezer temp n/a
medium risk csp risk level
bud room temp 30 hours bud fridge temp 9 days bud freezer temp 45 days
immediate use
bud room temp: 1 hour bud fridge temp: N/a bud freezer temp: n/a
butabarbital
butisol c3
marijuana or cannabis (tetrahydrocannabinol or cannabidiol)
c 1
mescaline
c 1
peyote
c 1
lysergic acid diethylamide or LSD
c 1 LSD
Out-of-state controls
c3-5 may be dispensed by CA pharmacies if: - called into the pharmacy - on a CA approved security form - transferred in from another pharmacy
What schedule is tramadol (Ultram)?
c4
codeine containing cough syrups
c5 codeine with promethazine codeine with promethazine and phenylephrine codeine with guaifenisen
ezogabine
c5 n bn
immediate -use risk
clean, uncluttered functionally separate area providing stat IV administration in medical setting or ambulance only intended for emergency administration must be for administration within 1 hour
Can a clinic licensed to dispense rx, dispense c2's?
clinics may NOT order or dispense c2's HOWEVER, - a prescriber may write for a rx to be filled at an outside pharmacy - a prescriber may administer c2's at the clinic
treatment of oral thrush?
clotrimazole (Mycelex)
what are the requirement for pharmacist to prescribe naloxone ?
complete one hour of CE on the use of naloxone, or an equivalent curriculum based training program from a board-recognized school of pharmacy - must counsel patient with naloxone- when dispensing naloxene- do not and do not waive the patient counseling keep records of furnishing the naloxone for 3 years.
Section 11053 - 11364 of the California Health and Safety Codes cover what?
control and distribution of scheduled drugs or controlled substances
prescription must be kept for // for controlled rx?
controlled RX must be kept at the pharmacy for at least 2 years. after that, the pharmacy can choose to store the prescriptions off site for another year.
copy 1 dea
copy 1 dea is the supplier copy 2 dea copy 3 is the buyer or receiver
Disease Prevention Demonstration Project (DPDP)
county or city government mandate to sell needles/syringes OTC to prevent spread of blood-borne diseases - must register with city or county health department - provide written and/or verbal counseling on testing and treatment - counsel on needle disposal
regulations
developed and enacted by state agencies (eg; California Board of Pharmacy
dextroemphetamine
dexedrine, procentra, zenzedi
methamphetamine
dexosyn c2
hydromorphone
dilaudid, exalgo c2
CE must be completed
during each 2 years license period certificate must be kept for 4 years. After 7/1/19 - 2 hours must be pharmacy law/ethics. *License expires last day of pharmacist's birth month.*
pharmacist continue education (30 hours)
every 2 years except first cycle
What is the period that one must renew their license to continue to practice pharmacy?
every 2 years. if not renewed within 3 years of expiration, it shall not be renewed
Taking of a controlled substances Inventory
every 2 years; with schedule 2's every 3 months
Period one must renew license to continue to practice pharmacy
every 2 yrs if license not renewed within 3 yrs of expiration, it shall not be renewable
How often must a pharmacy DEA registration be renewed?
every 3 years
How often must a pharmacist complete an inspection of all floor stock and drugs maintained at a nursing station?
every 30 days (CCR § 70263[q][10])
How often does the pharmacy generate a controlled substance printout for refills of Schedule 3-5 prescriptions which contains the signature of the dispensing pharmacist?
every 72 hours (21 CFR § 1306.22) and has dispensing RPh signature on it.
self-assessment form
every odd numbered year before july 1 within 30 days, when there is a new pharmacy permit, a change in PIC, or a change in pharmacy location
Dedexmethylphenidate
facalin, focalin xr
True or false: a hospital *pharmacy tech* can package and seal the emergency supplies for use in the HCF.
false - needs to be RPh
Controlled Substance Utilization Review (CURES)
for all C2-4 - uploaded weekly
the purchaser must keep the copy 3 form 222 for how long ?
for at least 3 years all records related to schedule ii drugs ( orders, invoices, prescriptions, inventory records) need to be kept separate from other forms.
how long for hospital pharmacy chart order records for controlled substance ?
for at least 7 years ( controlled nhe non control la 3 years)
Written Rx
for controls - date must be in handwriting of the prescriber - must be on security form
When can C2's be called in?
for emergency situations - security form prescription must be received by the pharmacy within 7 days for SNF, intermediate care facilities, or licensed hospice care facilities
Consultant RPh duties
for hospitals with 100 beds or fewer - quarterly basis identify problems with drug ordering, storage, dispensing, record keeping, disposal, etc.
Nonresident Pharmacy Registration
for mail order pharmacies
What should be included in the *Incident Report*?
given to pharmacy's insurance company discoverable in arbitration civil actions or other proceedings Must include: - when and what occurred and what was learned and done about the error - *names of parties involved*
high risk
high risk la mau hu thoi gian ngan lai bud room temp 24 hours bud fridge temp 3 days bud freezer temp 45 days ngan ngay nhat for bud room and bud fridge temp
Exclusion to who may NOT own a pharmacy
hospital pharmacies owned by prescribers does NOT fall under category as prescribers cannot own a pharmacy
Can you give 90 day supply if written for 30?
if a rx is written for a chronic condition with multiple subsequent refills, RPh may dispense up to a 90 day supply (if the refills are available) and *shall notify the prescriber* NOT INCLUDED FOR: - controlled substances - psychotherapeutic medications
When shall the pharmacy notify the Bureau of Narcotic Enforcement if a prescriber fails to provide the security form prescription for an emergency fill?
if rx is not received within 7 days, the pharmacy must notify the Bureau of Narcotic Enforcement within 144 hours (6 days)
Pre/Post dating prescriptions...
illegal .
bankruptcy, insolvency, or receivership
immediately
When to report (call) potential child/elder abuse/neglect?
immediately to law enforcement.
how old is the person to be administered by pharmacist ? by the CDC ?
independently initiate and administer immunization published by the CDC to patients 3 years or older. if under 3 years old, a physician protocol is still required.
Self-Assessment of pharmacy record (includes both sterile and non-sterile compounding
keep for 3 yrs complete every odd year before July 1st
ketamine
ketalar c 3
statute
law created by state legislature
Can rx be sent using the internet?
law dow NOT disallow rx transmitted over the internet
Records for non-‐controlled substances are maintained on the licensed premises for how long?
least 1 year from date of dispensing (CCR § 1707)
Records for controlled substances are maintained on the licensed premises for how long?
least 2 years from date of dispensing (CCR § 1707)
Administration action
licensee breaks the law or violates professional conduct standards parties involved: BoP against pharmacist's license compensation: revoking, suspending, or probation of license
diphenoxylate/atropine
lomotil c5
eszopicolone
lunesta c4
pregabalin
lyrica c5
difenoxin/atropine
motofen c 4
difenoxin with atropine
motofen half strength dc already but c5
morphine
ms contin, kadian, duramorph, arymo er, morphabond er, infumorph
furnishing of drugs during State of Emergency
must be declared by federal or state official - may furnish "reasonable" quantities during declared state of emergency - must be for rx that pt may have already received - need sufficient or reasonable evidence that pt needs and has been getting rx if no past records exist - keep in separate ledger must be documented to pts PCP asap
Renewal time period on a pharmacy permit
must be renewed yearly
Renewal time period on a sterile compounding license
must be renewed yearly
pre-printed, multiple check off rx
must have the boxes checked off, and include on the blank, the number of drugs prescribed
Movantik peripherally selective opioid antagonist OIC
naloxegol
Envizo
narcan auto-injector
pentobarbital
nembutal c2
Rules for providing medically indigent patients access to rx drugs
no cost to indigent (people in poverty) people from voluntary drug repository by donations from pharmacies, SNF, wholesalers, and county facilities any donated meds must: - not be controls - not be adulterated, misbranded - not be in the possession of a previous pt, only medical staff - donated only if in an unopened, tamper evident package or modified unit dose container - maintained in donated packaging units until dispensed - dispensed in a properly labeled container - segregated from pharmacy's other drug stock - not be expired
Maximum amount of time a pharmacist may leave the pharmacy and leave the other non-pharmacists in the pharmacy
no more than 30 min, for meal or other breaks
What is the max amount of time a RPh may leave the pharmacy with non-pharmacists in the pharmacy?
no more than 30 minutes for meal or other breaks
high risk compounding
non sterile ingredients non sterile equipment csps from bulk drug containers, preparations that require sterilization, and products made with non-sterile components
When can prescription records be moved to offsite storage?
non-controls: - after 1 year Controls: - after 2 years
What is the expiation date for any compounded prescription
not to exceed 6 months
tapentadol
nucynta c2
armodafinil
nuvigil c 4
Can a RPh fill a preprinted, multiple checkoff rx?
only if it is on a security prescription form. if not, no!
emergency refill provision for c3-5
only if pt did not receive drug - immediate hazard to pts health and welfare - pt might experience severe suffering
can a non-resisdent pharmacy transport sterile drugs into california?
only if they are licensed from CA BOP. license must be renewed annually
Dimethyl Sulfoxide (DMSO)
organic solvent, not available by mnf as FDA approved - used for management of topical arthritis - high absorption index, relatively significant blood levels within a short period of time
oxycontin
oxycodone er
Who may sign for receipt of prescription drugs delivered to pharmacy after pharmacy orders from wholesaler
pharmacist & pharmacy intern
Who can restock an ADDS with re-stocked removable drawers
pharmacist, intern, or tech (under RPh supervision)
What is the definition of a pharmacy being "closed down"
pharmacy no longer engaged in activity it was licensed for, for not operating at least one day per week in a 120 day period
Definitions of a pharmacy being "closed down"
pharmacy no longer engaged in activity it was licensed for, or not operating at least 1 day per week in a 120-day period
California Business and Professions Codes found between Sections 4000 - 4426 pertains to what?
pharmacy practice matters
phendimetrazine
phendimetrazine c 3
phenobarbital
phenobarbital c 4
Noxafil (4oz. btl w/ dosing spoon)
posaconazole: broadest spectrum,fewer DDI, take with full meal
phenergan, phenadoz, promethegan
promethazine
phentermine/ topiramate
qsymia c4
cholestyramine: take with food to bind chelesterol
questran
What is required for Advanced Practice Pharmacist certificate renewal?
renewed every 2 years - 10 hours CE in addition to 30 hours for regular licensing (total 40 hours)
loss/theft of controlled drugs
report to the DEA immediately ( one business day) report to california board of pharmacy within 30 days
methylphenidate
ritalin, ritalin LA, concerta, cotempla xr-odt, methylin, quillichew er , quillivant xr, aptensio xr, metadate er, daytrana
Label on a compounded RX
shall contain - generic name(s) of active ingredient(s) - statement saying "compounded by pharmacy" - labeled with name, AI, concentration, volume, lot numbers, exp date - bar coding required if units of dose are prepared at centralized hospital pharmaacy area to be used at other hospitals
Beyond Use Dating for Sterile compounds prepared solely with aseptic manipulation
shall not exceed 12 hours
Interim period for a temporary pharmacist-in-charge
shall not exceed 120 days
carisoprodol
soma c4
zaleplon
sonata c4
butorphanol
stadol c 4
Within how many days must the DEA be notified of *controlled substance loss* (or theft)?
upon discovery (within 1 business day)
How often do controls need to be electronically submitted to CURES?
weekly
Sterile compounding: Exterior workbench surfaces and other hard surfaces in the designated area, such as walls, floors, ceilings, shelves, tables, and stools are disinfected how often?
weekly
submitting dispensing data to CURES
weekly
Within how many days must the BOP be notified by the PIC if a licensed employee of the pharmacy is involved in the theft, diversion, self-use of drug or exhibits behavior representing an impairment that affects that persons ability to practice?
within 14 days
Within how many days must the Board be notified by the PIC if a licensed employee of the pharmacy is involved in the theft, diversion, or self-use of a drug or exhibits behavior representing an impairment that affects that persons ability to practice?
within 14 days
theft by or impairment of a license
within 14 days
If no security rx for schedule 2 is sent by prescriber pursuant to and emergency oral order - time period notification to Bureau of Narcotic Enforcement
within 144 hours after 7 days of the emergency oral order
Period of time rx records must be produced from an off-site storage facility when requested
within 2 business days
Period of time PIC must do investigation and report once a medication error is discovered
within 2 business days of discovery of error
medication error investigation
within 2 days of error
Within how many days must the BOP be notified of a change of address or name?
within 30 days
Within how many days must the BOP be notified of a change of pharmacy ownership?
within 30 days
Within how many days must the BOP be notified of a change of the pharmacist-in-charge?
within 30 days
Within how many days must the BOP be notified regarding any change in the pharmacy permit?
within 30 days
Within how many days must the Board be notified of a change in pharmacist-in-charge?
within 30 days
Within how many days must the Board be notified of a change of an address or name?
within 30 days
Within how many days must the Board be notified of a change of pharmacy ownership?
within 30 days
Withinhow many days must the Board be notified regarding any change in the pharmacy permit?
within 30 days
change in the pharmacy permit
within 30 days
change of pharmacist -in -charge
within 30 days
change of pharmacist address or name
within 30 days
Within how many days must the BOP be notified of any loss of controlled substances, including their amounts and strengths?
within 30 days (if controlled substance, also report to the DEA and submit DEA 106 form within 1 business day
Within how many days must the Board be notified of drug loss (by destruction or pilferage?
within 30 days (if controlled substance, DEA must be notified IMMEDIATELY)
What is the period of time rx records must be produced from an off-site storage facility when requested
within 48 hours
Once a medication error is discovered, how long does the PIC have to investigate and report it?
within 48 hours of discovery
PIC can be in charge of another pharmacy with what distance?
within 50 miles - can only be in charge of 2 pharmacies total.
If no security rx for schedule II drug is sent by prescriber pursuant to an emergency oral order-time period notification to DEA
within 6 days after 7 days of the emergency oral order
Number of days in which a prescription for a schedule II drug must be filled
within 6 months of the date prescription was written
Number of days in which a rx for a schedule 2 drug must be filled
within 6 months of the date rx was written
Number of days in which a rx for a schedule 2 drug must be filled if written for a terminal ill pt in a SNF and time limit for filling total rx if rx is partially filled at intervals
within 60 days of the date rx was written
Number of days in which a rx for a schedule II drug must be filled if written for a terminally ill patient in a SNF & time limit for filling total rx if rx is partially filled at intervals
within 60 days of the date rx was written
how long can a c2 rx for a SNF or terminally ill patient valid for if partially filled?
within 60 days of the date written
When must a C2 security rx be sent by the prescriber to the pharmacy pursuant an emergency oral order?
within 7 days
Schedule 2 security rx to be sent by prescriber to pharmacy pursuant to an emergency oral order by prescriber
within 7 days from date ordered
when shall pharmacy send report to CURES?
within 7 days of controls 2-4 being dispensed
Centralized hospital packaging pharmacy - can provide unit dose mediations to one or more acute care hospitals under common ownership and located....
within 75 miles. Unit dose must be barcoded!
sodium oxybate
xyrem c 3
*Centralized* Pharmacies must renew a specialty license every...
year
Can controlled substance be mailed to patients in california?
yes, the US mail service now allows prescription medications that contain any controlled substance to be mailed if: - pharmacy is DEA registered - for rx, inner container is labeled to show name and address of pharmacy and prescriber, and outside is properly wrapped in plain paper - the outside wrapper or container is free of markings that indicated the nature of the contents
Spacers
↓ oropharyngeal deposition of the medicine Prevent oral candidiasis ↑ lung deposition of the medicine ↑ the response to beta2 agonists
