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CA BOP Vision Statement
"Healthy Californians through quality pharmacist's care."
IV:PO 1:1 non-abx drug
"LaM Fixes Va Phenytoin Filters" L - Lorazepam M - Metoclopramide F - Famotidine V - Valproic acid P - Phenytoin F - Fluconazole
Record Keeping and reporting requirements
(p. 124)
Federal Warning Label for Controlled Substances for *Schedule II - IV* (schedule V does NOT require this)
*"Caution: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed"*
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.
If a licensed pharmacy staff member is engaged in theft, diversion or self-use of drugs it must be reported to the board within: (p. 106)
*14 days*
Must report if a licensed person or employee is chemically, mentally, or physically impaired to the extent that it affects his/her ability to practice, must notify board w/in: (p. 114)
*14 days*
Notify the board within _________ days if licensed individual is engaged in theft or diversion or self use of prescription drugs belonging to the pharmacy (p. 114)
*14 days*
Pharmacist in Charge can supervise up to...
*2 pharmacies* as long as they are within *50 driving miles. *
Internet Pharmacies (p. 53 bottom)
*2 types of internet pharmacies* 1. Legitimate mail order pharmacies 2. Rogue Internet pharmacies Legitimate mail order pharmacies dispense meds to patients (human or animal) *only with a Rx from a prescriber who has performed an appropriate exam* Rogue pharmacies do NOT left off p. 54
A pharmacist can supervise _________ interns at a time (p. 19)
*2*
Purchaser of scheduled medications must keep copy #3 of DEA form 222 (and all scheduled drug forms) for at least: (p. 88, #13)
*3 years* Need to keep *ALL* records related to *CII* drugs separate from all other forms --orders --invoices --prescriptions --inventory records
Treatment of Drug Addiction (p. 104 bottom)
*Addiction* - Chronic, relapsing brain dz characterized by compulsive drug seeking and use, despite harmful consequences "Strong need to use drugs for recreational/emotional purposes" *Opioid Tx programs* (p. 105) 1. Methadone (5,10, 40 mg tabs) --40 mg tabs *only for addiction* --5,10 mg tabs for *pain tx and addiction* --*pro-arrhythmic opioid* 2. Methadone clinics hard to get to so use of *Buprenorphine* under the *Drug Addiction Treatment Act (DATA)*
Distribution of Controlled Substances Between DEA Registrants (p. 106)
*CI & CII* 1. Form 222 or its electronic equivalent to distribute schedule I and II drugs *CIII - CV* 1. Invoice is used to distribute CIII - CV drugs 2. Must contian: --drug name --dosage form --strength --quantity --date transferred --Recipient's (name, address, DEA #) *ALL* transfer records are kept for at least *3 years*
Recalls (p. 119)
*Class I*: harm likely to occur pharmacist must notify the pt's *physicians* and keep a record of physician notifications The *physician* is responsible for deciding whether or not his/her pt's should be contacted *Class II* recall cause temporary or reversible adverse health consequences i.e. possibility of particles in vials *Class III* recall NOT likely to cause adverse health consequences Pharmacy recalling *sterile compounded drugs* must: 1. contact the recipient pharmacy, prescriber, or pt 2. report to the board within *12 hours* of the recall recall notice goes as follows: 1. if directly dispensed to pt: then notice must go to pt 2. if directly to provider then notify provider 3. if to pharmacy then notify the provider
Furnishing Naloxone (p. 64)
*Covers ALL forms of Naloxone* 1. Autoinjector (Evzio) 2. Injection (generic naloxone) 3. Nasal spray (Narcan) Naloxone can be given if opioid overdose is suspected: 1. Respiratory depression 2. CNS depression *if there is a question about whether to use Naqloxone, USE IT, since fatality can result w/ lack of use* Anyone administering MUST *also call 911*
Prescription Requirements (p. 21)
*DEA* required for ANYONE prescribing controlled substances An Employee or agent (nurse or secretary), under the supervision of a prescriber *CAN* communicate info to a pharmacist for dispensing The agent can also prepare an Rx for the prescriber to sign and date
Prescribing authority (Certified Nurse-Midwife, CNM)
*Dependent Authority* all drugs pursuant to a protocol in place must register w/ DEA if Rx'ing controlled substances
Prescribing authority (Nurse Practitioner, NP)
*Dependent Authority* all drugs pursuant to a protocol in place must register w/ DEA if Rx'ing controlled substances
Prescribing authority (Physician Assistant)
*Dependent Authority* all drugs pursuant to a protocol in place must register w/ DEA if Rx'ing controlled substances
Refill pharmacies
*Label must contain:* 1. name and address of refilling *and/or* originating pharmacy must be included on the label 2. Written info describing which pharmacy to contact for questions *BOTH* pharmacies are responsible for: 1. accuracy of fills *Originating pharmacy is responsible for:* 1. counseling pts 2. maintain med profiles 3. performing drug utilization review BEFORE delivery of each Rx
Manufacturing v.s. Outsourcing Facilities v.s. Traditional Compounding (p. 51 bottom)
*Manufacturing* 1. Regulated by: FDA 2. Standards and Regs: FDA, CGMP 3. Individual Rx required? No 4. Interstate Distribution: Yes *Outsourcing facilities* 1. Regulated by: FDA 2. Standards and Regs: 503*B*, CGMPs, USP 795 & 797 3. Individual Rx required? No 4. Interstate Distribution: Yes *Traditional Compounding* 1. Regulated by: State Board 2. Standards and Regs: 503*A*, USP 795 & 797 3. Individual Rx required? *Yes* 4. Interstate Distribution: Up to *5% of total sales* "5% rule" CGMP: Current good manufacturing practices
MedGuides MUST be given out when: (p. 33)
*Outpatient*: 1. *Every time* an initial fill and refill in an outpatient setting, when the drug will be taken by the patient without the supervision of a HCP 2. *First time* drug is being dispensed to a healthcare provider for admin to a pt in outpatient clinic etc. 3. Whenever a pt/caregiver asks for it 4. If the drug is part of a REMS program 5. If the MedGuide has been revised
P-gp Substrates: P-gp Inducers: P-gp Inhibitors:
*P-gp Substrates:* -PO anticoagulants (EAR-xaban, dabigatran) -digoxin -carvedilol -ranolazine -cyclosporine, tacrolimus, sirolimus -colchicine -saxagliptin -fexofenadine, posaconazole -simperevir, paritaprevir, sofosbuvir, dasabuvir, ombitasvir -atazanavir, dolutegravir, raltegravir *P-gp Inducers:* -CPPRS -tipranavir -dexamethasone *P-gp Inhibitors:* -clarithromcin, itraconazole, posaconazole -amiodarone, dronedarone, diltiazem, verapamil, carvedilol, quinidine -cobicistat, ritonavir -simeprevir, partaprevir, ledipasvir, daclatasvir -cyclosporine, ticagrelor, flibanserin
Child Resistant Packing (p. 30)
*PPPA* (poison Prevention Packaging Act) Enforced by *Consumer Product Safety Commission* Child resistant caps - prevent children *5 and younger* from opening med bottles NEW bottle and child-resistant cap needs to be used for *EACH* Rx dispensed The *PRESCRIBER* can *WAIVE* the requirement for the patient if they request an "*easy open container*" - per Rx The *PATIENT* can sign a waiver for *ALL Rx's* and can have all Rx's in an easy to open container
Correcting errors on an Rx
*Pharmacist can change on own: "minor revisions"* 1. misspelling of a drug name *Required to call Prescriber:* 1. Changes made by the prescriber should be documented 2. or Rx can be re-written as an oral prescription and original will be VOIDED 3. or the prescriber can send another Rx Different for controlled substances
Correcting Error or Omission on a Controlled Substance Prescription (p. 98-99)
*Prescription MUST be signed and dated* by the prescriber everything else can be written by the prescriber or his/her agent The pharmacist can make changes to any other information on the prescription as long as the pharmD verifies the change with the prescriber 1st
Transferring Controlled Substance Prescriptions (p. 104)
*Schedule II drugs canNOT be transferred* *Schedule III - V* 1. Only *1* transfer is permitted (Exception: if pharmacyies share a "real time online database of pts, i.e. chain pharmacies, from one rite aid to another) 2. Prescription copy is pulled and *"VOID"* is written on the face of the Rx 3. Pharmacy receiving the transfer must reduce the Rx to writing and must write *"TRANSFER"* on the face of the Rx 4. DEA of each pharmacy must be recorded 5. Records must be kept for *3 years*
Prescription Refills
*Schedule III and IV Controlled Substances* 1. Limited to *MAX 5 refills* within *6 months* 2. ALL *refills* combined cannot exceed a 120-day supply the *original fill is NOT a refill*, NOT included when counting the 120-day supply *NO refills for Schedule II drugs* 5 refills that need to be filled within 6 months and cannot be for more than 120 days of actual therapy
Refills of Controlled Substances: *Schedule III - V* (p. 101)
*Schedule V* 1. Refilled up to 6 months from the date of issue 2. there is *NO* refill or day supply limit as long as it is authorized by the prescriber *Schedule III-IV* 1. may be refilled up to 5x w/in 6 months of the date written 2. all refills together canNOT exceed a *120-day supply* *The original Fill does NOT count as a "refill" towards the 120-day supply limit*
Biennial self-assessment form
*completed by PIC when* 1. every odd # year before July 1st (QOY) 2. within *30 days* of pharmacy receiving a new permit 3. within *30 days* if the pharmacy has a new PIC Self-assessment kept on site for *3 years*
Standardized formatting for labels (p. 28)
*do NOT apply to inpatient labels* *4 items* MUST be clustered into 1 area of the label and comprise at least *50% of the label* Must be in *12-point sans serif typeface* in the following order 1. Name of pt 2. Name of drug and strength of drug --trade name + manufacturer --generic name + manufacturer 3. Directions for use of the drug 4. Condition or purpose for which the drug was Rx'd "IF" indicated on the prescription Must *BOLD* the above info, put in color, or use blank space to set off the 4 critical items above
Prescribing authority (Dentist)
*independent authority* CII - CV, limited to scope of practice Req DEA license
Prescribing authority (Pharmacist)
*independent authority* Limited to the following: 1. EC 2. self-admin hormonal contraception 3. Travel meds rec by the CDC, NOT requiring a diagnosis 4. Routine immunizations rec by the CDC for *3+* years old 5. Naloxone 6. Prescription nicotine replacement products *Dependent Authority* all other drugs w/ protocol in place must register w/ DEA if Rx'ing controlled substances
Prescribing authority (Optometrist)
*independent authority*, limited to scope of practice 1. must be certified w/ the board of optometry to prescribe drugs 2. Letter *"T"* at the *end of their license number* 3. Codeine or Hydrocodone containing drugs: *3 day supply maximum* - require a DEA number 4. can prescribe other drugs: Abx, eye drops etc
Prescribing authority (Podiatrist)
*independent authority*, limited to scope of practice CII - CV, limited to scope of practice Req DEA license
Prescribing authority (Veternarian, DVM)
*independent authority*, limited to scope of practice CII - CV, limited to scope of practice Req DEA license
Prescribing authority (Naturopathic Doctors, ND)
*independent authority*, limited to scope of practice Limited to the following: 1. Epinephrine 2. Natural and synthetic hormones (need DEA to Rx controlled substances such as Testosterone) 3. vitamins, minerals, aminoacids, i.e. things available w/OUT a prescription 4. All other non-controlled drugs and *schedule III-V* if registered w/ the DEA and *under physician protocol* Must have *NDF* by furnishing number in order to prescribe meds -provided by the bureau of naturopathic medicine
4. Furnish Rx nicotine replacement products
*nicotine replacement products* --inhaler (Nicotrol) --Nasal spray (Nicotrol NS)
If the medication cannot be made into a unit dose deliver package, it is not suitable for unit dose TCT filling
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Pharmacist must disclose on the license renewal form if they have been convicted of any violation of alw, except for traffic infractions under 300 dollars that do not involved alcohol, dangerous drug or CS
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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
Requirements to be a Pharmacist
- 18 years old + - Graduated pharmacy school - Pass NAPLEX and CPJE - Pass background check
Aid in Dying Pt Requirements
- 18+YO - CA resident - Mentally competent - Terminally ill (w/in 6mo confirmed by 2 MDs)
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
Rx Refills (CV)
- 6mo expiration from date on rx *No max refills or days supply limit
High Alert Drugs
- Adrenergic agonists (epi) - Adrenergic antagonists (beta blockers) - Anesthetic agents (Versed, Prededex, propofol) - Antiarrhythmics (amiodarone) - Unfractionated Heparin - Insulin - Inotropic Meds (dig, milrinone) - Opioids - Neuromuscular blockers - Hypertonic saline - Potassium - Epidurals - Cytotoxic drugs (chemo)
Schedule III Drugs
- Anabolic steroids - Buprenorphine containing products - Butabarbital - Butalbital containing products - Codeine/APAP - Dronabinol - Ketamine - Sodium oxybate
Drugs that require MedGuides
- Antidepressants - NSAIDs - Some Anti-psychotics - Anticonvulsants - Long Acting Beta Agonists - Most Antiarrhythmics - Insomnia Drugs - ADHD - Retinoids
Schedule IV Drugs
- Armodafinil - Benzos - Carisoprodol - Diethylpropion - Lunestsa - Belviq - Phenobarbital - Phentermine - Belsomra - Tramadol - Sonata - Ambien
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)
Furnishing Travel Medications
- Complete immunization program - Complete Travel Med Program (at least 10 hours) - Complete CDC Yellow Fever Program - Complete 2 hours of CE every 2 years
Do NOT Substitute
- DAW1 - Between long acting and short acting - Combo products for single ingredient products
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
Label requirements for prescriptions
- Drug name (and manufacturer if generic) - Directions for use - Name of pt - Name of prescriber - Date of issue - Name and address of pharmacy - Prescription number - Strength of drug - Quantity of drug - Expiration date - Physicial description of the drug
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
Advanced Practice Pharmacist (APP) requirements
- Earn certification in a relevant area of practice (amb care, critical care, oncology, etc) - Complete a residency - Have provided clinical services to patients for 1 year under a CPA **requires 2 of the 3
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
Brand to Generic
- Generic must be cheaper than brand - Communicate switch to patient - Do not sub if DAW1
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
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
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
Naloxone Furnishing
- Must complete 1 hour CE - Pt counseling can not be waived - Provide board approved fact sheet
Furnishing Nicotine Replacement Therapy
- Must complete 2 hour CE - 1 hour of continuing CE every 2 years Records are kept for 3 years
Repackaging Pharmacies
- 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
Components of a Prescription
- Name of pt - Address of pt - Name and qty of drug - Directions for use - Date of issue - Prescriber Info (name, address, telephone number, license classification, DEA number if controlled) - Prescriber's signature *If from a vet, must have type of animal and name and address of owner
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
PRN Refills
- Only for non-CS - Max 1 year (standard of practice?)
To Dispense Emergency Contraception
- PharmD must complete 1 hr of CE - EC Fact Sheet must be provided
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
Authorized Prescribers (independent authority)
- Physician (MD/DO) - Dentist (DDS) -Podiatrist (DPM) - Veterinarian (DVM) - Optometrist (OD) - a T will be at the end of license - Naturopathic Doctors (ND) - only vitamins, minerals, epinephrine, hormones, etc - Pharmacist (Pharm.D.) - naloxone, nicotine, EC
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
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
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
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.
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
CA Security Prescription Features
- VOID watermark if photocopied - Chemical void protection that prevents chemical washing - Watermark on the back that reads "California Security Prescription" - Thermochromic ink feature - Quantity check off boxes - "Prescription is void if number of drugs prescribed is not noted" - Date of origin of the prescription - Identifying number assigned to approved security printer by Dept of Justice
C4 drugs
-Provigil (modafinil) -Nuvigil (armodafinil) -BZD (lorazepam, diazepam, etc) -Ambien (zolpidem); Lunesta (eszopiclone); Sonata (zaleplon) -Belsomra (suvorexant) -Soma (carisoprodol) -tramadol containing products (Ultram, Ultracet, Conzip) -phenobarbital -Adipex-P (phentermine) -Qsymia (phentermine/topiramate) -Belviq (lorcaserin) -diethylpropion -difenoxin/atropine -butorphanol
C3 drugs
-butabarbital -Fioricet (butalbital/caffeine/acetaminophen); Fioricet w/ codeine -Fiorinal (butalbital/caffeine/aspirin); Fiorinal w/ codeine -Tylenol #3,4 (codeine/acetaminophen) -Ketalar (ketamine) -buprenorphine containing products (Belbuca, Butrans, Suboxone, Subutex) -Xyrem (sodium oxybate) -Marinol (dronabinol) -phendimetrazine -benzphetamine -anabolic steroids such as testosterone (AndroGel)
C2 drugs
-cocaine -codeine -hydrocodone containing products -oxycodone containing products -MS Contin, Kadian (morphine) -Opana (Oxymorphone) -Dilaudid, Exalgo (hydromorphone) -Duragesic (fentanyl) -alfentanyl -sufentanil -Demerol (meperidine) -Nucynta (tapentadol) -Dolophine, Methadose (methadone) -amobarbital, pentobarbital, secobarbital -Adderall -amphetamine -Desoxyn (methamphetamine) -Dexedrine (dextroamphetamine) -Vyvanse (lisdexamfetamine) -Ritalin, Concerta (methylphenidate) -Focalin (dexmethylphenidate) -paregoric -LAAM or levo-alpha acetyle methadol -levorphanol
prescription label requirements
-drug name - either brand name OR generic name and manufacturer -directions for use -pt name -name of prescriber -date of issue -name, address of pharmacy -Rx # -strength of drug -quantity of drug -expiration date (manufacturer OR 1 year) -purpose (if written on prescription) -physical description of drug
documentation for transfers
-identification of Rph or intern on both sides -name and ID code/address of each pharmacy -original date and last fill -# original fills -# of refills remaining/transferred
optometrist prescribing authority
-must be certified with board of optometry; T at the end of license # -max 3 DS for codeine/hydrocodone containing pdts -oral analgesics, OTC, oral abx, topicals, eye drops
when can 30 DS be changed to 90 DS
-non-controlled, non-psychiatric drug -pt has completed initial 30 DS with no ADEs -pt previously received a 90 DS -Rph notifies MD of increase in # dispensed
Drug classes use for migraines?
-triptans Ergot alkaloids: Migranal [dihydroergotamine] Fioricet Prophylaxis topiramate FROVA [frovatriptan succinate] for acute migraine treatment
Mnemonics for warfarin
1 --- Pink -------- Please 2 --- Lavender -- Let 2.5 -- Green ----- Green 3 --- Brown ----- Barret 4 --- Blue ------- Bring 5 --- Peach ----- Pistols 7 ---- Teal ------- To 7.5 -- Yellow ---- Your 10 --- White ----- Wedding
A pharmacist can only supervise ______ tech trainee for up to ____hours
1 Tech trainee for up to 120 hours.
how many technician trainees can a pharmacist supervise
1 at a time and only for up to 120 hours
Immunizations
1 hour CE q 2 years Notify physician/CAIR2(CA immunization registry 2) 14 days,
Separate multiple injection locations by at least: (p. 58)
1 inch
community setting tech ratio
1 pharmacist - 1 tech 2 pharmacist - 3 tech 3 pharmacist - 5 tech
hospital setting tech ratio
1 pharmacist - 2 tech
tech ratio in the community/outpatient setting
1 tech for the first pharmacist on duty 2 techs for each additional pharmacist on duty
How many times can C III - V drugs be transferred?
1 transfer Original hard copy must be pulled and VOID written on it
How long to keep md error/QA reports
1 year
How long to keep pt med profile
1 year
How long to keep records? Med error/quality assurance reports
1 year
How long to keep records? Patient medication profile
1 year
Patient medication profile
1 year
how long are patient profiles kept for?
1 year
medication error/quality assurance reports
1 year
non-controlled substance Rx need to be kept in the pharmacy for how long?
1 year
patient medication profile: keep for atleast?
1 year
How long must a patient's profile be kept in the system?
1 year from the date of last filled prescription.
How long must patient medication records be kept for?
1 year from the last dispensed drug date
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.
California Smoking Hotline for behavioral changes?
1-800-NO-BUTTS
Pharmacist Breaks
1. *30 min* 2. can only dispense *refills* that have *already been checked* by the pharmacist Can NOT dispense initial fills/New Rx's while pharmacist is NOT there
Labeling for each unit dose (p. 53)
1. *Date* med was prepared 2. *Beyond use date* (no later than either of the following) --*Per USP guidelines*-- --1 year from date drug is repackaged --Expiration date on manufacturer's container 3. *Name of drug* 4. *quantity of each active ingredient* 5. *special storage or handling requirements* 6. *Lot/Control number* --should be linked to: --components used in the drug --expiration date of each drug component --NDC number
Partial Fills of *Schedule III-V* Rx's (p. 102)
1. *No dispensing can occur beyond 6 months from the date of issue* 2. other than above, treated the same as partial fills for non-schedule drugs
Converting a 30-day supply into a 90-day supply (p. 26)
1. *Non-controlled, non-psychiatric drug* 2. the pt has completed the initial 30 day supply with NO negative effects 3. *the total quantity dispensed including refills does NOT exceed the amount authorized on the prescription* 4. pharmacist must notify the prescriber
Name tags
1. 18 point font 2. worn at all times *at work* 3. State: Name and License Status
Pharmacist Licensure
1. 18+ yrs 2. ACPE accredited school of pharmacy or (grad of FPGEC - foreign school of pharmacy and certified by NABP's foreign pharmacy graduate examination committee) 3. 150 hours of semester college credit (90 from pharmacy school) 4. 1,500 hours of pharmacy experience (900 in a pharmacy) 5. Pass NAPLEX and CPJE
Check digit for DEA number
1. Add 1st, 3rd, 5th numbers together 2. Add 2nd, 4th, 6th together then multiple this answer by 2 3. Add The sum of Step 1 and Step 2 together The last digit should match the last digit of the prescriber's DEA number
CIII
1. Anabolic steroids (testosterone/androgel) 2. Dronabinol (marinol) 3. Ketamine 4. Butalbital/Apap/caffeine/codeine (Fiorinal)
Drugs that *REQUIRE* MedGuides
1. Antidepressants 2. some antipsychotics 3. Anticonsulsants 4. LABA's 5. Antiarrhythmics 6. NSAIDs
CIV (p. 85)
1. Armodafinil (Nuvigil) 2. *Benzodiazepines* 3. Lunesta 4. Lorcaserin (Belviq) 5. Tramadol 6. Zolpidem (Ambien)
Health Screenings (p. 73)
1. Body fat analysis 2. BP 3. Cholesterol 4. DM 5. Tobacco use 6. Bone density 7. Depression
Auxiliary labels: 1. Controlled substance, Dangerous unless used as directed. Caution: state & federal law prohibits the transfer of this drug to any other person other than the patient for whom it was prescribed. 2. Shake Well before using 3. For External use ONLY 4. Finish all this medication unless otherwise directed by prescriber
1. C2-4 drugs 2. all suspensions, most asthma aerosol inhalers, nasal steroid sprays, lidocaine viscous topical liquid 3. topicals. may require "for the eye/ear/nose/rectal/vaginal/not for PO, etc." 4. antibiotics, antivirals, antifungals
Self-prescribing for family members (p. 23)
1. CAN self-prescribe for *NON-controlled substances* as long as: -- there is a valid physician/patient relationship --legit medical purpose, --good faith exam
Schedule II prescriptions (p. 86)
1. CanNOT be transferred to another pharmacy for the purposes of dispensing to a patient pt needs to bring the original Rx if they want a drug filled at a pharmacy
CII's (p. 84)
1. Cocaine 2. Codeine 3. Meperidine (demerol) 4. phenobarbital 5. Tapendatol (Nucynta)
CV (p. 85)
1. Codeine containing cough syrups 2. Lacosamide (Vimpat) - anticonvulsant 3. Pregabalin (lyrica)
Written Info Provided to Patient
1. Consumer Med Info (CMI) leaflets 2. Patient Package Inserts (PPI) 3. Medication Guides (MedGuides)
Types of Written Patient Information
1. Consumer Medication Information (*CMI*) --NOT reviewed by the FDA --purpose: to supplement oral counseling 2. Patient Package Inserts (*PPI*) --for all estrogen-containing drugs --Hospital or long-term care: before admin and every 30 days 3. Medication Guides (*MedGuides*) --FDA approved pt handouts that come with many prescription medications --manufacturer's MUST supply the pharmacies w/ Medguides (physical or electronic so pharmacy can print out the medguides for pts)
Must be included in pt counseling (p. 36)
1. Directions for use 2. Directions for storage 3. Precautions and relevant warnings --common, severe adverse effects --interactions that can occur 4. Importance of compliance with the medications
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
Labeling requirements for refills (p. 28)
1. Drug name 2. directions for use 3. Name of the pt 4. Name of prescriber 5. Date of issue/date Rx was written 6. Name and address of pharmacy 7. Rx number 8. Strength of drug 9. Quantity of drug 10. Expiration date of the drug 11. condition or purpose of the drug (if written on the prescription must also be on the label) 12. Physical description of the drug (color, shape, imprint
APP requirements
1. Earn a certificate in a relavent area of practice 2. complete a residency 3. Provide clinical services to pts for 1 year under a CPA or protocol w/ a physician, APP pharmacist or pharmacist practicing under a collaborative practice agreement
Advanced Practice Pharmacist (APh) Criteria
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
CII's can*NOT* be taken over the phone unless (p. 96)
1. Emergency situation - can fill enough to tide the pt over until an Rx can be received. 2. If the pt is a resident of: --licensed skilled nursing facility --intermediate care facility --Home health agency --hospice
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)
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. 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)
Who can order via Form 222
1. Licensed and *non-licensed* personnel who *the person registered w/ the DEA to order controlled drugs* gives "*Power of Attorney*" Power of Attorney is written documentation that the person can order scheduled drugs This form is *NOT sent to the DEA*, but is kept on file for an inspector
Cannot Substitute (p. 43)
1. Long acting to short acting 2. Combination drug products to multiple single agents
Counseling to pts who do NOT speak English (p. 37)
1. MUST have interpretive services during all hours 2. Employee or 3rd party
Epipen must be dispensed with: (p. 54)
1. Manufacturer's product sheet 2. name of person 3. designation section 1797.197a responder and "first aid purposes only" 4. Dosage, use, expiration date Can also provide EpiPen to school/district based on a physician's standing order If used in good faith: person who gave it is given immunity from prosecution
Name Tags
1. Must always wear at work 2. 18-point type 3. Name 4. License status
Mailed Rx's and counseling (p. 37)
1. Must provide a *LETTER* saying that the pharmacist is available if the pt has any questions + phone number for pt to call
Drugs in cabinets MUST be labeled with: (p. 48)
1. Name of drug 2. strength & dosage form 3. Manufacturer 4. Lot # 5. Expiration date
Rx's must contain: (Written, oral, fax)
1. Name of pt 2. Address of pt 3. Name and Quantity of drug/device 4. Directions for use 5. Date of issue Prescriber info required on a Rx 1. can be rubber stamped, typed, or printed by hand or typest 2. Name, address, phone # 3. Prescriber DEA# if controlled 4. Prescriber's signature 5. Conidition for which the drug is being prescribed *IF the pt requests* Veternarian 1. if controlled substance must include kind of animal + name and address of owner
When to provide Oral Counseling (p. 36)
1. New Rx 2. Refill is being dispensed w/ a diff dosage form, strength, or new written prescription 3. If the pt requests counseling 4. When pharmacists feels counseling is necessary
EC can be obtained by 3 options
1. OTC 2. Rx 3. Furnished by a CA pharmacist under the board's EC protocol
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)
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
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)
Advanced Practice Pharmacist (p. 17 bottom)
1. Perform physical assessments 2. Order and interpret drug therapy related tests 3. Refer pts to other healthcare providers 4. participate in the evaluation and management of patients w/ other HCP's 5. Initiate, adjust, and d/c drug therapy pursuant to a protocol (if APP is adjusting or initiating controlled substance therapy they need to be registered w/ the *DEA*)
Faxed Prescriptions for Controlled Substances (p. 96)
1. Prescriber must *sign* the fax prior to sending it 2. can be on a regular or security form --if on security form the word *"VOID"* will appear in the fax --*ok for pharmacy to still fill* as long as it is verified with the prescriber first *Schedule III-V drugs can be faxed* The only time a faxed Rx for Schedule II drug is valid is when: *the pt is a pt of a licensed skilled nursing facility, intermediate care facility, home health agency or hospice* --*the pharmacist will need to produce, sign and sate a hard copy of the Rx prior to filling it*
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
Pt requesting their records
1. Pt MUST be able to inspect their medical records within *5 business days* 2. Pt MUST receive copies within *15 business days* 3. maximum charge for copies $.25-.50
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 28hrs before taking med to give to attending MD
Requirements for Valid Controlled Substance PRescriptions
1. Signed and dated by the Prescriber 2. Rx only valid for *6 months* 3. DEA *must* be included if writing for a controlled substance ANY agent of the prescriber (nurse or office staff) can orally or electronically transmit an Rx for a controlled substance classified as *III, IV, V* Must write down the name of whoever is transmitting the controlled substance
Naloxone nasal spray (p. 65)
1. Take off yellow cap 2. screw on white cone 3. take purple cap off of naloxone capsule 4. screw naloxone capsule into barrel of syringe 5. short strong push of the plunger 6. half of capsule into each nostril If no reaction in *3 minutes* give second dose
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
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
checking validity of a DEA number
1. add the 1st, 3rd, and 5th digits 2. add 2nd, 4th, 6th digits 3. multiply the result of step 2 by 2 4. add step 1+ step 3
Intern pharmacist
1. all functions of a pharmacist 2. caNOT have a key to the pharmacy 3. All Rx's filled by an intern MUST be checked by a pharmacist
Dispensing drugs during a federal, state, local emergency (p. 55 bottom)
1. can dispense controlled and non-controlled and devices in reasonable quantities w/OUT a Rx. 2. Keep a record with: --date --pt name --pt address --Drug: name, strength, quantity 3. PharmD must make good faith effort to communicate that info to prescriber asap
Steps to follow if Furnishing Naloxone (p. 64 bottom)
1. complete *1 hour of CE* on the use of Naloxone 2. Ask if pt uses opioids or knows someone who does 3. Ask pt if known naloxone hypersensitivity 4. Provide reciptient w/ traning in opioid overdose: --prevention --recognition --response --administration of naloxone 5. Provide the board approved fact sheet 6. With pt's permission, notify PCP that naloxone was furnished *Pt counseling canNOT be waived* when dispensing Naloxone *keep records x 3 years*
Pharmacies that wish to be outsourcing facilities (p. 51)
1. drugs must be compounded in compliance with CGMP's 2. Facility must be licensed by the FDA 3. Preparations must be *made* or *under supervision* of licensed pharmacist 4. Must meed record keeping requirements --source of ingredients --sterility data --adverse event history 5. *any pharmacy or faility wishing to compound within california or distribute compounded products to California *Must be licensed in California* Out of state pharmacies that ship compounds to California MUST be licensed in California with the CA board of pharmacy
Eligibility requirements for California Outsourcing Facilities and 503b
1. engage Sterile drugs for humans 2. CGMP 3. Inspected by the FDA
Auxiliary labels (p. 29)
1. evidence based 2. simple language 3. Other language can be provided on the bottle OR in supplemental documents
Sxs of Opioid Overdose
1. extreme or unusual somnolence 2. Respiratory difficulty (slow shallow breathing to respiratory arrest) 3. Miosis (pinpoint pupils) 4. Bradycardia
5. Independently initiate and administer immunizations (*>/= 3 yrs old*)
1. immunizations recommended by the CDC 2. *3 yrs and older* 3. Physician protocol required if *< 3 yrs old*
Red Flags (p. 100)
1. irregularities on the face of the Rx itself 2. nervous pt demeanor 3. Age or presentation of pt (young pt seeking chronic pain medications) 4. Multiple pts w/ same residential address 5. Multiple prescribers for the same pt for duplicate therapy 6. Cash payments 7. Frequent requests for early refills 8. Suspicious Rx's brought in during "busy times" 9. Initial fills for strong opiates 10. Long distances traveled by the patient
1. Administer drugs and biologics
1. must be ordered by a prescriber 2. all routes of drug admin. (i.e. topical and injectable)
*May* also include in pt counseling
1. name and description of the drug 2. route of admin 3. dose 4. duration of therapy 5. What to do if a dose is missed
Quality Assurance Programs (p. 75)
1. national pt safety goals: joint commission --highlight problematic areas in healthcare --targets one area and recommends steps to improve safety and reduce risk 2. Standard order sets --list of orders for a specific condition --improve compliance w/ recommended care --reduce the need to call prescribers for clarification of an order --limit treatment options to recommended options 3. *Antimicrobial Stewardship* --optimize infection tx and reduce ADR's 4. *Medication Utilization Review* --improve the use of drugs to increase health benefits for patients 5. *Peer Review and Self-Evaluation* (p. 77) --performance evaluation process conducted by peers and/or self 6. *medication error reporting* (p. 77) --all pharmacies MUST have Quality assurance program to document, assess, and prevent medication errors --must have a readily retrievable policies and procedures for the QA program --investigation of pharmacy med errors must begin w/in *2 business days* from the date the med error was discovered to prevent forgetting what happened --*Root cause analysis* to discover what caused the error --QA record must be kept on site for *1 year* from the date it was created and must contain QA must include: 1. Date, location, participants in the QA review 2. Pertinent data + info related to error 3. findings and determinations 4. recommended changes to policy, procedure, systems Medication error notify: (p. 78 middle) 1. *patient* 2. *prescriber*
2. Furnish *self-administered* hormonal contraceptives
1. oral formulations 2. transdermal patch 3. Vaginal ring 4. Injection (depo provera)
what 4 critical items must be clustered into one area of the label that is atleast 50% of the label, printed in at least 12 point SANS SERIF type face?
1. patient name 2. drug name and strength 3. directions for use 4. purpose of drug
labeling requirements for Rx containers
1. pt name 2. drug name 3. strength 4. directions for use 5. purpose of drug (if noted on the rx) 6. prescriber's name 7. physical description of drug 8. quantity 9. expiration date 10. name and address of pharmacy 11. issue date 12. Rx number
Faxed Prescriptions (p. 24)
1. received ONLY from *prescriber's office* - not from pt's home 2. Reduced to a "hard copy"
Outsourcing Facilities/Section *503 B* (p. 50)
1. specially licensed compoudning facility to operate as an "outsourcing facility" 2. Prepare medications in *BUlk* to address shortages 3. *Compound these drugs w/ OUT a prescription* 4. To register as an outsourcing facility MUST compound *Sterile drugs for humans*
PIC
1. strict liability for violation of laws 2. may supervise up to *2* pharmacies 3. the 2 pharmacies MUST be w/in *50 driving miles* 4. any change of PIC must let the board know *in writing* within *30 days* 5. PIC can*NOT* be both a PIC and Designated Representative-in-charge (DRIC) for a wholesaler or vet food-animal drug retailer
It is Permissible to share PHI with: (p. 41)
1. the Patient 2. other HCP's providing care to the pt 3. Tx, payment, or operation (TPO) purposes 4. Other persons *authorized* by the pt 5. Public health and institutional operations (limited data search) 6. for a public health need
Exception to using the California Security form
1. use for the terminally ill 2. needs to including in writing: *"11159.2 exemption"* on non-security Rx Terminally ill = pt suffering from an incurable/irreversible illness that is expected to die w/in *1 year*
10. Take on EMPTY stomach
10. ampicillin -Bisphosphonates (30 mins before, 60 mins for Boniva) -PPI (before eating) -levothyroxine -Opana -iron -zafirlukast -captopril (1 hour before) -Cellcept (mycophenolate) -Vfend (voriconazole) -Sustiva/Atripla (efavirenz & combo) -didanosine -Crixivan (indinavir)
Max hours
108 hours in 2 weeks 9h/day 6d/w 1.5*pay>8h, 2x pay>12h exemp: administration not directly working with meds majoritee vote can allow longer work day w/out increase pay
11. Take with FOOD
11. Coreg (carvedilol) -metformin -Mevacor (lovastatin) -Lopid (30 mins before breakfast & dinner) -Lofibra, Lipofen, Fenoglide -niacin, Niaspan -phosphate binder -Opioids except Opana -NSAIDs -Steroids -Reyataz (atazanavir)
drug recalls: pharmacy must notify recipient and board within?
12 hours
Non-Controlled Substance expiry in California
12 months
12. Take with full glass of WATER 13. May cause DISCOLORATION of urine or feces 14. Check for PEANUT/SOY allergy -Check for EGG allergy
12. Bisphosphonates -Bactrim -Azulfidine (sulfasalazine) 13. entacapone levodopa rifampin metronidazole nitrofurantoin phenazopyridine 14. Diprivan (propofol) Cleviprex (clevidipine) Prometrium (progesterone) -Diprivan (propofol) Cleviprex (clevidipine) Yellow Fever Vaccine Influenza vaccine (except FluBlok)
Patches frequency
12hr on 12hr off: Minitrans [nitroglycerin], Lidoderm 72hr: Fentanyl, scopolamine Daily: MS TRaN [methylphenydate, selegiline, testo, Rivastig, NicoT] 2 times a week: HRT, Urinary drugs EVA: Estraderm, Vivelle dot, Alora Ditropan or oxytrol TD [oxybutynin] Weekly: HRT, Alpha 2 Agonist, Addiction, COC HRT: Climara, Menostar Catapres [clonidine] Butrans [buprenorphine] COC Ortho Evra
BOP Board
13 members serving 1 or 2 4-year terms +/- executive officer who may or may not be a board member
If pharmacist is suspected of intoxication, must report to board within.....
14 days
Report theft by or impairment of a licensee by
14 days
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
theft: report DEA within 1 bus. day, board in 30 days BUT if theft or diversion by licensed individual or impaired pharmacy, report board within
14 days
if the original rx is not received (for emergency dispensing), the pharmacist must report to the california bureau of narcotic enforcement within?
144 hours
15. Avoid taking this medication with grapefruit
15. lovastatin, simvastatin, atorvastatin diazepam, triazolam verapamil, diltiazem nicardipine, nisoldipine, nifedipine, felodipine amiodarone buspirone carbamazepine tacrolimus, cyclosporine voriconazole
16. Do NOT take with DAIRY products, ANTACIDS, Mg, or IRON tablets 17. Do NOT CRUSH; Swallow whole 18. Warning: if stool becomes watery & soft, contact prescriber 19. Warning: this medicine may make Birth Control less effective
16. Tetracyclines & FQs 17. XR, ER, LA, SR, CR, SA, TR, TD, 24, timecaps, sprinkles, & controlled release ending in -cont (can split metoprolol ER & levodopa-carbidopa SR at score line) 18. clindamycin, broad-spectrum antibiotics 19.
How old do you have to be to purchase dextromethorphan?
18
age requirement for pharmacist
18
Dextromethorphan (Delsym) Sales
18+YO with photo ID or looks at least 25+YO
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.
number of interns a pharmacist can supervise
2
Pharmacists who participate in nicotine replacement program must have how many C.E. hours?
2 hours.
pharmacist to tech ratio in the institution setting
2 techs for each pharmacist on duty
How many pharmacies can PIC manage?
2 within 50 miles of each other
How long to keep Sudafed (etc) sales
2 years
How long to keep records? Pseudoephedrine, ephedrine, etc logs
2 years
Pseudoephedrine, ephedrine, pheynlpropanolamine, norpseudoephedrine sale logs
2 years
controlled substance Rx need to be kept in the pharmacy for how long?
2 years
pseudoephedrine, ephedrine, phenylpropanolamine, and norpseudoephedrine sale logs keep for atleast?
2 years
20. High Alert IV
20. epinephrine (adrenergic agonists) -Beta Blockers (adrenergic antagonists) -Antiarrhythmics (i.e. amiodarone) -Ionotropic agents (i.e. digoxin, milrinone) -Opioids -Anesthetic agents (i.e. midazolam, dexmedetomidine, propofol, etc) -UFH -Insulin
Electronic Rx's for Controlled Substances (p. 97)
2010 EPCS (electron Prescriptions for Controlled Substances) Ok to E-prescribe *CII - V* Must use DEA approved software
21. Paralytic, High Alert 22. Cytotoxic agent: Dispose of properly 23. NOT to be given IV; For IRRIGATION ONLY
21. Neuromuscular blocking agents (roccuronium, vecuronium, cisatracurium, pancuronium, succinylcholine) 22. Chemotherapeutic agents 23. peritoneal dialysis irrigation solution, saline & sterile water irrigation solution
All actions related to ordering tests, interpretation and management must be documented w/in:
24 hours
drug recalls: outsourcing facility must notify recipient and board within?
24 hours
25. Administer by IM injection 26. Central Line Only
25. promethazine (CI <2 yo) 26. hypertonic saline -Epi, DA, dobutamine -CaCl, KCl -most chemotherapeutics -amiodarone, Synercid (in small volume) -PTN central formula
number of pharmacies PIC can supervise
2; must be within 50 miles of each other
Contraceptive Screening by pharmacists must be kept for....
3 Years.
optometrists max day supply for codeine combination products and hydroconde combination products?
3 day supply
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.
physical inventory of C2 is performed every?
3 months
Furnishing Emergency Contraception (p. 60 bottom)
3 types of meds 1. *levonorgestrel* 2. *Ulipristal* 3. High dose birth control pills (pharmacist *CAN* furnish as off-label EC) Both can be recommended up to 5 days after unprotected sex Ulipristal: Rx ONLY Ulipristal > levonorgestrel at 3-5 days post unprotected sex
Biennial controlled substances inventory
3 years
Community or Clinic pharmacy Rx's
3 years
Controlled substance inventory
3 years
DEA 222, power of attorney forms
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 prescriptions?
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 records? Biennial controlled substances inventory
3 years
How long to keep records? Community or clinic pharmacy prescriptions
3 years
How long to keep records? Controlled substance inventory
3 years
How long to keep records? DEA 222, power of attorney forms
3 years
How long to keep records? Purchase invoices for all prescription drugs
3 years
How long to keep records? Self-assessment forms
3 years
How long to keep records? Theft and loss reports for controlled substances (DEA 106)
3 years
How long to keep self-assessment forms
3 years
How long to keep the pharmacy self assessment forms?
3 years
How long to keep theft and loss reports of CS (DEA 106)
3 years
Purchase invoices for all Rx drugs
3 years
Record documenting return of drugs to wholesaler or manufacturer
3 years
Record documenting transfers or sales to other pharmacies, licesees and prescribers
3 years
Rx records must be kept for how long?
3 years
Self-assessment forms
3 years
Theft and loss reports of controlled substances (DEA Form 106)
3 years
chart orders for non-controlled substances are kept for?
3 years
dea forms 222 are kept for?
3 years
how long to keep prescriptions
3 years
how long to keep self-assessment forms
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
Minimum age for an immunization by pharmacis
3 years old
Naloxone documentation must be kept for a minimum of....
3 years.
Nicotine Replacement documents kept for....
3 years.
Initiating and Administering Immunizations (p. 60)
3+ yrs old Routine immunizations recommended by the *ACIP* and published by the *CDC* Can also *initiate and administer:* 1. Epinephrine 2. diphenhydramine by injection Required to initiate and give immunizations 1. CDC or ACIP approved immunization training program 2. maintain basic life support certification 3. comply with all federal and state record keeping
Pseudoephedrine Limits
3.6 grams per day 9 grams in 30 day period 3 packages per transaction
How many CE hours are pharmacist required to have for renewal?
30
Continuing education
30 CE hours every 2 years, retain for 4 years Exception for active military 10 hour Aph 1 hour hormone contraceptive 1 hour naloxone 1 hour immunization 2 hour nicotine replacement 2 hour travel 2 hour travel
Pharmacy change in PIC. When should the board be notified?
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
Reporting Time Period? Change of pharmacist address or name
30 days
Reporting Time Period? Change of pharmacist-in-charge
30 days
Time to notify board of discontinuation of drug take back service
30 days
Time to notify board of establishment of drug take back service
30 days
change of PIC must inform board within ___ days
30 days
A new PIC must complete an inventory within...
30 days of becoming PIC.
How much continuing education (CE) is required?
30 hours every 2 years
CE requirements
30 hr every 2 years *first 2 years - exempt
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.
Risk Evaluation and Mitigation Strategy (REMS)
4 parts to MedGuides 1. communication plans 2. elements to assure Safe use (ETASU) 3. Implementation Systems 4. MedGuides
Certificate of completion for CE
4 years
How long do CE certificate of completion must be kept?
4 years
How long to keep CE records
4 years
How long to keep records? Certificate of completion for continuing education
4 years
how long to keep CE certificates
4 years
record: certificate of completion for continuing education?
4 years
Must keep CE records for?
4 years.
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
Time MD has to countersign nurse's order
48 hours
An order in the hospital can be entered by staff other than the provider. But the provider must sign off in...
48 hours.
In California, patients must be able to inspect theirmedical recods within ?
5 business days and receive copies within 15 business days.
max refills for CIII and CIV
5 refills within 6 months all refills combined cannot exceed a 120-day supply (not including first fill)
5. Keep in Refrigerator. DO NOT FREEZE
5. pen VK ampicillin Augmentin Many cephalosporins, except Omnicef vancomycin valgancyclovir erythromycin/benzoyl peroxide gel (Benzamycin) Humira (adalimumab) Enbrel (etanercept) Interferons Miacalcin (calcitonin NS) Forteo (teriparatide) Liotrix (thyrolar) Insulins that patients are not using Mycostatin (nystatin pastilles) ESA Neupogen (filgrastim) Kaletra (lopinavir/ritonavir solution) Norvir (ritonavir) Octreotide (sandostatin) Caverject, MUSE (alprostadil) Foradil (formoterol - prior to dispensing) Pulmozyme (dornase alfa) Canasa (mesalamine suppository) promethazine suppository NuvaRing lactobacillus Vivotif (typoid PO capsule) chlorambucil etoposide somatropin Xalatan (latanoprost) Zioptan (tafluprost) Viroptic (trifluridine)
Substitution
500=2*250 ok! Can sub capsule for tabs for sol. Form not route change ok! Can't change cream for ointment, thats different. If no sub is checked they still need to initial for it to count
Controlled Substance Prescriptions Valid for How Long?
6 months
Controlled Substance expiry in California?
6 months
3Ts have to be kept for?
6 years
How long to keep pt acknowledgement of HIPAA
6 years
How long to keep records? Patient acknowledgment of HIPAA
6 years
Patient acknowledgement of HIPAA
6 years
Transaction info, history, statement for most rx drugs under Drug Supply Chain Security Act
6 years
keep HIPAA acknowledgement for?
6 years
record: patient acknowledgment of HIPAA keep for atleast?
6 years
record: transaction ifnormation, history, and statement for select prescriptioin drugs
6 years
HIPPA Acknowledgement must be kept for...
6 years.
6. May cause Drowsiness. Use care when operating a car or dangerous machinery
6. Analgesics with CNS effects All C2-5 depressants & narcotics Hypnotics Skeletal Muscle Relaxants Dopamine Agonists (ropinirole, etc) Antihistamines Antinauseants Anticonvulsants Antipsychotics Remeron (mirtazapine) Desyrel, Oleptro (trazodone) Antihypertensives with CNS effects
Days
60 days if he supplier cannot provide the entire quantity, the supplier can provide a partial shipment and supply the balance within 60 days from the date on the form 222. 30 days self-assessment completed within 30 days if a new permit is issued or new PIC. 30 days If waiver for offsite storage of records is approved, a signed copy of the form will be returned to the pharmacy within 30 days. The pharmacy must be able to provide the record within 2 bus. days on the request of the board. Once travel med dispensed by rph, notify the PCP within 30 days 10 days When pharmacy closing, transfer of drug notice must be sent to board within 10 days in writing. (if CS involved, notify DEA 14 days in advance) 14 days once immunized, report CAIR within 14 days.
Medicare Qualifications
65+ Kidney failure or transplant Open enrollment: October 15-December 7 7 month period starting 3mo. before they turn 65
Hospital Pharmacy Chart orders for Controlled Substances must be kept for...
7 Years.
How long to keep records? Hospital pharmacy chart order of controlled drugs
7 year
Hospital pharmacy chart order records for controlled substances
7 years
How long do controlled substance orders have to be kept in a hospital?
7 years
How long to keep hospital pharmacy chart order records for CS
7 years
chart orders are controlled substances are kept for?
7 years
record: hospital pharmacy chart oder records for controlled substances keep for atleast?
7 years
7. May cause blurry vision
7. amiodarone digoxin (yellow halos) Anticholinergics PDE5 Inhibitors hydroxychloroquine tamoxifen isoniazid, ethambutol isotretinoin scopolamine patch voriconazole Potiga
Centralized Hospital Pharmacy Packaging radius?
75
8. Do NOT take with alcohol
8. disulfiram -tinidazole, metronidazole (48 hours after last dose) -Opioids -Barbiturates -BZD -non-BZD Hypnotics -tramadol -Nucynta (tapentadol) -Skeletal muscle relaxants -Anticonvulsants -Antipsychotics -Some Antidepressants -Insulin -metformin -Sulfonylureas -Nitrates
Point to Your Language Sign
8x11 print paper signage required in pharmacy
9. Avoid prolonged exposure to the sunlight
9. Sulfa Antibiotics (Bactrim) -Tetracyclines -FQs -metronidazole -voriconazole -Topical Retinoids & PO isotretinoin -Diuretics (thiazide & loop) -carbamazepine -methotrexate -tacrolimus -St. John's wort
What day supply can a prescriber write for per patient visit? (p. 98)
90 day supply via *sequential Rx's* all written on the same day --each for a 30 day supply etc Prescriber writes up to 2 or 3 prescriptions (*cannot exceed 90 days total*) CanNOT be postdated *Must include 2 dates* 1. date written 2. earliest acceptable fill date
if a prescriber issues multiple prescriptions in one office visit for the same schedule drug to be filled sequentially, how much is the max day supply?
90 days
Remote dispensing pharmacy
<225 Rx per day calculated each year. Medically underserved area no pharmacy w/in 10 road miles No RPH needed but must be w/in 150 road miles RpH can use Telepharamacy to monitor technician Use barcodes for verification Tech can sign for orders, but Controls set aside
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
Sudafed max Iodine
>18yo. 3.6g/day 9g/mo. 7.5g/mo. mail order store 2 years Iodine max 2.2%
Pricing Requests
>5 RX pricing requets can request written and respond w/in 10 days and charge Not required to respond to >3 requests in 6mo. Not required for controls, competitor or out of state
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
Condoms
A pharmacist can provide up to 12 condoms under Medi-Cal and Family PACT for each client who obtains EC
Office use controls (p. 107)
A prescriber can*NOT* write an Rx to get controlled substances for purposes of *stocking them for office use* or to dispense to patients Prescriber *MUST* purchase controls directly from pharmacy or wholesaler
Pre-signing and Post-dating prescriptions for controlled substances (p. 98)
A prescription for a controlled substance must be dated and signed on the *date when issued* *Pre-dating and post-dating controlled Rx's is illegal*!!! Physician instead writes and dates all the prescription on the date written *includes 2 dates* 1. date written 2. earliest acceptable fill date
No product quantity limits for EC (p. 62)
A pt can purchase EC for future use *an EC fact sheet* MUST be provided to the pt when furnishing emergency contraception
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
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
orange book A and B
A- therapeutically equivalent B- not therapeutically equivalent
antipyrine/benzocaine/glycerin
A/B Otic Analgesic/antiinflammatory
DEA Number First Letter
A/B/F/G - hospital/clinic/practitioner/pharmacy M - Mid level practitioner P/R - Manufacturer/distributor/researcher/importer/exporter/narcotic treatment program *second letter is the first letter of prescriber's last name*
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
Medicare Parts
A=Hospital B= Medical insurance like Dr. Visits (RX discount) C=Medicare advantage plan (RX) D=Optional for prescriptions
Tech requirements
AA degree 18 point font on name tag="Pharamcy Technician" Trainee: 1 RPH/Trainee "18 point Student trainee"
DEA practitioner DEA
ABFG
Non sterile BUDs
AKA do not start after Non-Sterile compounds Aqueous Oral 14 days Aqueous topical 30 days Nonaqueous 6mo. 180days
Authentic DEA
AL 8010869 First letter is practice (ABFGXMPR) Second Letter is MD last name 8+1+8=17 0+0+6=6*2=12 17+12=29 last number =last digit 9
acetaminophen
APAP/Tylenol/Ofirmev PO, IV(undiluted), PR Fever and pain MOA: Inhibits prostaglandin synthesis and hypothalamic heat-regulating center SE: Not common; IV-GI, increase LFTs Stor/Stab: IV-room temp, use w/n 6hrs
Advanced Practice Pharmacist
APH 2 of below Complete residency Certification in practice area 1 year collaborative practice 40CE every 2 years Assess patient, order/interpret drug therapy Initiate, adjust and DC medications
aripiprazole
Abilify Weight-neutral
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
zafirlukast
Accolate
quinapril
Accupril
isotretinoin
Accutane PO iPledge program
rabeprazole
Aciphex/Aciphex Sprinkle PPI
permethrin
Acticin Scabies
risedronate
Actonel
risedronate/calcium carbonate
Actonel and Calcium
pioglitazone/metformin
Actoplus Met TZD/Biguanide
pioglitazone
Actos TZD
ketorolac
Acular/Toradol Opht, PO, IM(slow/deep), IV(bolus over 15 sec) MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 1 drop QID, 15-30mg q6hr IV; 10mg q4-6hr PO; max of 120mg/d *Not to be used more than 5 days *Decrease by 50% in mild renal failure SE: Burning (Acular), HA, GI, dizziness *NSAIDs increase risk of serious CV events Stor/Stab: Protect from light -inj is slightly yellow
DTaP
Adacel
Tdap
Adacel, Boostrix
dextroamphetamine/amphetamine salts
Adderall/Adderall XR
fluticasone/salmeterol
Advair MDI/Advair diskus DPI
niacin/lovastatin
Advicor
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
dipyridamole/aspirin
Aggrenox
spironolactone
Aldactone Aldosterone antagonist
methyldopa
Aldomet Alpha-2 agonist
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
Administering Injectable Drugs and Biologics
All licensed pharmacists can administer drugs and biologics via injection
Health Insurance Portability and Accountability Act (HIPAA) (p. 40)
All personnel involved with PHI have to have documented HIPAA training fines up to 50,000 + 10 yrs in prison for each HIPAA violation Only obtain the "minimum necessary" info required for the job (p. 41)
Records and storage
All prescriptions for 3 years (1 year on site non-control, 2 year control, retrieved in 48 hours) (Hospital 7 years) Self assessment keep 3 years Purchases/sales of drugs/medical devices 3 years HIPAA written disclosure/conset kept on file for 6 years! Authorization document Pseudaphed 2 years, can be sold w/out Rph QA/Med error report 1 year Patient profile for 1 year after last entry Board of pharmacy permit 1 year (Voided if no activity in 120 days, object in 10 days)
fexofenadine
Allegra
fexofenadine/pseudoephedrine
Allegra-D 12H/Allegra-D 24H +decongestant
Emergency filling of Schedule III-V drugs *without prescriber's authorization*
Allowed for non-scheduled and *Schedules III-V* PharmD must make every reasonable effort to contract prescriber
brimonidine
Alphagan/Alphagan P alpha-2 agonist/glaucoma
ramipril
Altace
aluminum hydroxide
AlternaGel/Amphojel
glimepiride
Amaryl Sulfonylurea
zolpidem
Ambien/Ambien CR
Emergency Medical Service Automated drug delivery
Ambulances, restocked by pharmacist, medical director, or paramedic
What to do when taking amiodarone or verapamil with digoxin?
Amiodarone and verapamil are a P-gp inhibitor which blocks digoxin from being pumped out; therefore, decrease the dose of digoxin.
What to do if warfarin and amiodarone is taken together?
Amiodarone is a CYP3A4 inhibitor of the substrate warfarin so decrease warfarin dose by 50%
amoxicillin
Amoxil
Dextrose
Amphotericin B Synercid Bactrim
Saline
Ampicillin Unasyn Dilantin Invanz Cancidas (capsofungin) Cubicin Remicade (infliximab) (AUDI CCR)
Employee of the prescriber dealing with Rx's
An Employee or agent (nurse or secretary), under the supervision of a prescriber *CAN* communicate info to a pharmacist for dispensing The agent can also prepare an Rx for the prescriber to sign and date
clomipramine
Anafranil
cefazolin
Ancef/Kefzol 1st gen IV/IM
Year
Annual separate board-issued sterile compounding license for nuclear pharmacy compounding, sterile injectable compounding, ophthalmic products compounding, inhalation products compounding. Compounding P&P is reviewed by PIC annually. Outsourcing facilities: licesne issued by the board before starting business within or into CA, which renewed yearly. Pharmacy permit renewed yearly.
Disclosure of service and location of each receptacle
Annually, at time of facility license renewal
disulfiram
Antabuse
Indirect Factor Xa inhibitor Monitor Arixtra [fondaparinux]
Anti-Xa Hgb, Hct, PLATELET SCr
Can you use antiplatelet for Afib?
Antiplatelet like plavix are NOT used for Afib Antiplatelet can be used for ACS or PCI stent Anticoagulants like Xarelto or Savaysa [edoxaban] are use for afib
Barcoding (p. 53)
Any unit dose med produced by a centralized hospital packaging pharamcy *shall be barcoded to be machine readable at the inpatient's bedside* Nurse scans drug barcode then pt's barcode to ensure: *right pt, right medication, right dose, right route of admin*
Own a Pharmacy
Anyone but a prescriber RPH /Intern can sign for drug receipt, exception, if secure storage they can drop off. Remote dispense pharamcy a tech can sign, but controls must be placed away and have RPH sign later, recorded and kept for 120 days
insulin glulisine
Apidra
apomorphine
Apokyn DA agonist
Orange Book (p. 42)
Approved Drug Products with Therapeutic Equivalence Evaluations 1. Published by the FDA 2. Guide for therapeutically equivalent drugs Orange book available via: 1. Print 2. FDA website Purpose: 1. to provide pts w/ cheaper medications 2. *Cost-Savings* MUST be communicated to the pt if a generic substitution is made 3. If generic is picked: must include generic name and manufacturer's name 4. If brand is used: ONLY need to have the brand name (since it is registered directly w/ the manufacturer)
Off-site record storage
Approved, but only if a waiver is granted by BOP Records must be produced within 2 business days upon request by BOP - must keep non-controlled in the pharmacy x 1 year - keep controlled in pharmacy x 2 years
hydralazine
Apresoline Direct vasodilator
darbepoetin alfa
Aranesp ESA
leflunomide
Arava PO
PRN Refills
Are accepted in California for NON-controlled substances Should expire *1 year* after the date written do NOT fill prn refills 1 year after the date written amount of times refilled depends on day's supply (bottom p. 25)
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.
donepezil
Aricept/Aricept ODT AChEi
anastrazole
Arimidex
fondaparinux
Arixtra Factor Xa
dessicated thyroid
Armour thyroid
trihexyphenidyl
Artane Anticholinergic
diclofenac/misoprostol
Arthrotec PO - OA and RA MOA: COX-1 and -2 inhibitor; prostaglandin analog Dose: 50mg/200mcg 3-4x/d *Give after meal to decrease GI upset SE: GI, increase ALT *NSAIDs increase risk of serious CV events *USE IS CI IN PREGNANT WOMEN*
Non-controlled prescriptions can be transferred ...
As many times as there are refills.
It is permissible to share PHI with: the patient patient's healthcare provider persons whom authorized by the patient Aaaaand?
As part of a limited data set for research, public health or institutional operations for a public health need (including natural emergencies), drug abuse issues for law enforcement, the DEA, medical board inspectors, pharamcy board inspectors, or to report adverse drug reactions to the FDA.
mesalamine
Asacol/Pentasa/Rowasa Crohn's disease
mometasone
Asmanex twistihaler MDI
acetylsalicylic acid
Aspirin/Ecotren
azelastine
Astelin Nasal spray
Keep drug acquisition records, disposition records
At least 3 years
candesartan
Atacand
hydroxyzine
Atarax/Vistaril 1st gen Not interchangeable - HCl vs pamoate
lorazepam
Ativan
emtricitabine, tenofovir, efavirenz
Atripla NRTI, NRTI, NNRTI Empty stomach at bedtime
ipratropium
Atrovent
amoxicillin/clavulanate
Augmentin/Augmentin XR/Augmentin ES
antipyrine/benzocaine
Auralgan
irbesartan/HCTZ
Avalide
rosiglitazone/metformin
Avandamet TZD/Biguanide
rosiglitazone/glimepiride
Avandaryl TZD/sulfonylurea
rosiglitazone
Avandia TZD
irbesartan
Avapro
moxifloxacin
Avelox
dutasteride
Avodart
nizatidine
Axid H2RA
Axid
Axid [nizatidine] H2RA
triamcinolone
Azmacort MDI
brinzolamide
Azopt CA inhibitor
sulfasalazine
Azulfidine PO Crohn's disease
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.
Short Stability Drugs
BAC -- Bactrim F -- filgrastim L -- levothyroxine I -- infliximab P -- phenytoin "short stability BACtrim F L I P"
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
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
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)
Dextrose only compatibility
Bactrim amphotericin B Synercid (quinupristin/dalfopristin) pentamidine Cellcept IV (mycophenolate) carfilzomib
May make birth control less effective
Barbiturates Bosentan Rifampin Rifapentine Ampicillin Anticonvulsants Tetracycline St. Johns wort HIV drugs Griseofulvin (BBRRAATS HG)
PIC must complete biennial pharmacy self assessment form...
Before July 1st of each odd numbered year.
Mid level practitioner DEA
Begins with the letter M (Nurses, physicians assistant)
diphenhydramine
Benadryl 1st gen
What are some pregnancy safe Anti-Histamine?
Benadryl Claratin [loratidine] Chlor-trimeton [chlorpheniramine]
probenecid
Benemid
olmesartan
Benicar
dicyclomine
Bentyl
benzoyl peroxide/clindamycin
BenzaClin/Duac
benzoyl peroxide/erythromycin
Benzamycin
sotalol
Betapace/Betapace AF III (K)
betaxolol
Betoptic Beta-blocker for glaucoma
clarithromycin
Biaxin/Biaxin XL
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)
DEA requires that controlled substances inventory be done
Biennially (Every other year)
CI in CrCl < 30
Bisphosphonates Avanafil Arixtra NSAIDs K-sparing diuretics Tramadol ER Xarelto Pradaxa Cialis Cymbalta (BAANK TX PCC)
sulfacetamide
Bleph-10 Optical antibiotic
timolol
Blocadren
INH
Blurred vision Photosensitivity
List of Rx pads that have been stolen can be found where: (p. 94)
Board of pharmacy's website
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
ibandronate
Boniva
terbutaline
Brethine PO bronchodilator
esmolol
Brevibloc
bumetanide
Bumex Loop
buspirone
Buspar
Fioricet
Butalbital 50 mg (controlled), caffeine 40 mg, APAP 300 mg
Fiorinal
Butalbital 50 mg (controlled), caffeine 40 mg, ASA 325 mg CIII
Patient brings a prescription for Lortab on 9/15/2018. The prescription was written on 9/1/2018. Patient wants partial fill. By when is patient allowed to pick up the remainder quantity?
By 9/30/2018 Partial fill within the 30 days from the date of issue.
exenatide
Byetta/Bydureon (ER) GLP-1 agonist
nebivolol
Bystolic
CHA2DS2VASc
C - CHF - 1 H - HTN - 1 A2 - Age older than 75 - 2 D - Diabetes -1 S2 - Stroke - 2 V - Vascular disease - 1 A - 65 to 75 - 1 S - Sex female - 1
What are D5W only Drugs?
C- Cipro B -- Bactrim A -- amiodarone S -- Synercid A -- amphotericin b "Cooking BASA fish with sugar"
What are some CYP3A4 Inhibitors?
C-SPAN talked about CYP3A4 inhibitor Macrolide C -- Cyclosporin, Cimetidine S -- Statin, Synercid, P -- Protease Inhibitors A -- Azoles N -- Non-DHP: Verapamil, Diltiazem Macrolide - Clarithromycin, Erythromycin, Telithromycin but NOT azithromycin Vibativ [telavancin] Synercid [Dalfopristin / Quinupristin]
When you give vaccination to a patient, report is sent to where within how many days?
CAIR within 14 days of admin.
Continuing education/licensure
CE: *30h every 2 years* License expires on the LAST day of the pharmacist's birth month 1st 2 pharmacy years are EXEMPT from having to do CE CE certificate kept for *4 years*
When drug is being repackaged, it should be done according to what kind of practice?
CGMP
Counting Opened CS Containers
CI-II need exact count CIII-V - Bottles of 1000 or less can be estimated - Bottles >1000 require exact count
Inventory
CII count every 3 months CIII-V every 2 years Estimate if <1000 Exact if >1000 Maintain for 3 years
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."
Parkinson Drug Classes
COMT inhibitors - use to increase levodopa Carbi/Levo - Sinemet, Rytary ER, Duopa DA Agonist - Mirapex, Requip, Neupro, Apokyn
CSOS v.s. Form 222 (p. 88-89)
CSOS: Controlled Substance Order System 1. can be used to order drugs from *ALL* schedules (1-5) 2. has NO order quantity limits 3. Supplier must report transaction to DEA w/in 2 business days of filling the order Form 222: 1. only for CI and CII, paper order form 2. can only order *up to 10 drugs* at a time 3. Supplier reports transaction to the DEA by the end of the month during which the order was filled
amlodipine/atorvastatin
Caduet DHP/Statin
Unlike loop diuretic HCTZ is a up in what?
Calicium
C-2 Called in/Faxed
Call: Only by Physician, and only in an emergency Secure script w/in 7 days if no script inform DEA w/ 6 days Fax: Only long term care facility/hospice
Oral prescriptions for CII Cannot be...
Called in except for an emergency.
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
Hypodermic Needle and Syringes (p. 111)
Can administer needles and syringes to patients with*OUT* an Rx when: 1. pharmacist knows the pt 2. 18+ years as a public health measure to prevent transmission of HIV etc 3. *NO limit* to the number of needles/syringes that can be provided Pharmacies that sell syringes without an Rx *must* provide safe disposal of needles and syringes by: 1. selling or furnishing sharps containers, mail back containers, or on-site sharps collection and disposal 2. written or verbal counseling to customers --access drug tx --access testing for HIV, HCV --how to safely dispose of sharps waste
Extended scope of practice on protocol
Can administer oral/topical check Blood glucose/cholesterol BP and inform result furnish hormone contraceptive Drug vitals/labs Furnish nicotine replacement Furnish Naloxone (even to roomate) Immunization Travel meds
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
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
Drug Diversion
Can buy stock from another pharmacy but must return it (only for Emergencies)
Class I Recall
Can cause serious adverse health consequences Pharmacist notifies physicians and the physician is responsible for contacting patients
Class II Recall
Can cause temporary or reversible adverse health consequences
Prescriptions from out of state (p. 99)
Can dispense *schedule III - V directly to the patient* if: 1. written on a California security form 2. orally authorized *Schedule II* 1. Can be *mailed* to the out-of state residence (can*NOT* dispense CII directly to the pt) 2. must meet the requirements for controlled substances from the state it was written in
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
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
Out of state prescriptions (p. 23)
Can fill a drug or device pursuant to a *written or oral* order from a prescriber licensed outside of California Pharmacist CAN dispense the prescription *DIRECTLY* to the patient Controlled substances
Out of State Rx
Can fill and dispense to a patient all but C-2 Can be phoned in from out of state MD C-2 Can fill and deliver to patients ORIGINATING state.
State of emergency
Can fill any rx without refills even if patient has never been to your pharmacy Reasonable amount of time Mobile pharmacy: in the emergency area, stop operating w/in 48 hours of emergency discontinuation, common ownership w/ a licensed pharmacy. If goes permanent tell board w/in 3 days
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
Can perform *"Non-discretionary"* tasks --can not include the ability to make decisions according to the technician's judgement 1. *removing drugs from stock* 2. *counting* 3. *pouring or mixing pharmaceuticals* 4. *placing product into containers* 5. *Applying labels*
Pharmacy Technician Roles
Can perform nondiscretionary tasks (type, fill, etc so long as the task doesn't need RPh judgment) under direct RPh supervision
Clerk abilities
Can receive refill phone calls as long as not controlled substance
"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
Intern pharmacist
Can't hold the keys to the pharmacy 1RPH can watch 2 Interns if RPH on lunch they turn to tech.
Date or Name
Cannot be missing from the RX or added for II-V drugs.
Dextromethorphan (p. 112)
Cannot be sold to anyone < *18 yrs old* Must check ID before purchasing Can be kept on the floor shelves outside of the pharmacy with other OTC products (cashier just checks for ID)
Rx Transfers (CII)
Cannot transfer
captopril
Capoten
sucralfate
Carafate Gastro-protective
nicardipine
Cardene DHP
diltiazem
Cardizem/Cartia/Tiazac Non-DHP
doxazosin
Cardura/Cardura XL
clonidine
Catapres Alpha-2 agonist
cefaclor
Ceclor 2nd gen PO
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
cefuroxime
Ceftin 2nd gen PO/IV/IM
cefprozil
Cefzil 2nd gen PO
celecoxib
Celebrex PO (can be sprinkled on food) MOA: COX-2 selective NSAID at higher doses Dose: 100mg BID or 200mg daily. Higher for gout *Use not rec in severe renal/hepatic disease SE: GI, increase LFTs, URTIs *NSAIDs increase risk of serious CV events
citalopram
Celexa
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.
Authorized Prescribers (dependent authority)
Certified Nurse-Midwife (CNM) Nurse Practitioner (NP) Physician Assistant (PA)
varenicline
Chantix
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"
guaifenesin/codeine
Cheratussin AC
guaifenesin/codeine/pseudoephedrine
Cheratussin DAC
chlorpheniramine
Chlor-Trimeton 1st gen
tadalafil
Cialis [Adcira (PAH)]
ciprofloxacin
Ciloxan
Protect from light
Cipro Lasix Levaquin Amiodarone Amphotericin Mycamine Phytonadione Doxycycline Flagyl Flolan Nitropress (CLLAAMPD FFN)
ciprofloxacin/hydrocortisone
Cipro HC
ciprofloxacin
Cipro/Cipro XR
ciprofloxacin/dexamethasone
Ciprodex
cefotaxime
Claforan 3rd gen IV/IM
desloratadine
Clarinex
desloratadine/pseudoephedrine
Clarinex-D 12H/Clarinex-D 24H +decongestant
loratadine/pseudoephedrine
Claritin-D 12H/Claritin-D 24H +decongestant
loratadine
Claritin/Claritin Reditabs/Alavert
Which antiarrythmic cause QT prolongation?
Class 1A - DisoP, Quinidine, Procainamide Class 3 - amiodarone, ibutilide, sotalol
What is NYHA Class III?
Class III: Minimal activity like walking across room can cause issues Class IV: Shortness of breath even at rest.
clindamycin
Cleocin
Persistent diarrhea
Cleocin Broad-spectrum abx
Pharmacy Clerk/typist
Clerk Allowed to: 1. can type prescription labels 2. enter prescription info into a computer 3. Request and receive *Refill* authorizations NOT allowed to: 1. fill rx medications 2. handle drugs in ANY manner EXCEPT for purpose of ringing up the patient at the cash register *NO maximum limits* on number of clerks in a pharmacy
CLIA
Clinical Laboratory Improvement Amendments Pharmacists can give cholesterol, A1C, blood glucose, using this waiver certificate
sulindac
Clinoril PO MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 150-200mg BID; max of 400mg/d *Onset may take up to 1 week *Avoid use in renal impairment SE: Edema, dizziness, rash, GI *NSAIDs increase risk of serious CV events
REMs
Clozapine Isotretinoin Qsymia Forteo Addyi Saxenda, Symlin Thalidomide ER/LA opioid analgesics (CIQFASTE)
clozapine
Clozaril/FazaClo REMS High risk for weight gain/metabolic SE
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
C5 drugs
Codeine containing cough syrups Lomotil (diphenoxylate/atropine) Lyrica (pregabalin) Potiga (ezogabine) Vimpat (lacosamide)
benztropine
Cogentin Anticholinergic Used for EPS symptoms
tacrine
Cognex AChEi/cholinergic agonist
docusate
Colace
colcicine
Colcrys
colestipol
Colestid Max 16g tab or 30g powder/day
Check for peanut or soy allergy
Combivent (not Respimat) Prometrium
ipratropium/albuterol
Combivent/DuoNeb
zidovudine/lamivudine
Combivir NRTI, NRTI
Centrilized Hospital Packaging pharmacy
Common owned Hospitals w/in 75 miles of eachother
Pharmacy ratios
Community 1 RPH:1 Tech:2 Interns:1 Trainee 2 RPH:3 Techs: 4 interns:2 Trainee Inpatient 1 RPH:2 Tech: 2 Interns: 1 Trainee 2 RPH: 4 Techs:4 interns: 1 Trainee If community pharmacy is filling for an inpatient pharmacy they use inpatient ratio, but once they are done they revert
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.
Acceptable amount of technicians per pharmacist
Community: 2n - 1 Hospital: 2n *n = number of pharmacists
prochlorperazine
Compazine/Compro 1st gen antipsychotic Mostly used as antiemetic
Nuclear Pharmacy (p. 52)
Compounding radioactive drugs for diagnostics and treatment 1. Nuclear pharmacist MUST be in the pharmacy whenever radioactive drugs are being provided to medical staff 2. Require *Sterile Compounding permit* from the board
Stolen Perscription pad
Contact DOJ/CURES/PDMP w/in 3 days Medical board by email or letter explaining what happened and actions taken
Medication Error
Contact Prescriber and Patient Immediately Conduct investigation w/48 hours Document QA program, save 1 year Date, Location, participants Pertinent data Findings Recommended changes No need for names Incident report to insurance company (Includes names of parties involved) Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program (MERP) Vaccine Errors Reporting Program (VERP) MedMARx: Hospitals to anonymously report MEDWATCH: for Adverse events
Medication/Chart Order (Hospital Pharmacy) (p. 52)
Contains the same information found on a Rx 1. Medication order 2. Chart order for a medication (name, drug, dose, frequency, etc) Someone OTHER than the prescriber can put in an order i.e. pt has nausea, prescriber tells the nurse to give pt ondansetron, nurse puts in the order, *prescriber then has 48 hours to physically or electronically sign the order* All orders for *Controlled Substances* in a hospital setting must be kept for a minimum of *7 years* *Standing order or Protocol or Order Set* Treatment plans designed to help direct acceptable care for select conditions
Name tag
Contains their name License status 18-point type
Prescribing for Family
Controlled AND non-controlled substances okay as long as MD/PT relationship is valid, legit med purpose, good faith exam
CSOS
Controlled Substance Order System - Electronic replacement for DEA 222 - No limits to quantity of drugs to order - Can order non controlled and C III-V as well
DEA 222 Colors and Who Gets What
Copy 1 - Brown - Supplier (or Pharmacy if CII are being returned to supplier) Copy 2 - Green - DEA ALWAYS Copy 3 - Blue - Pharmacy (or supplier if CII are being returned to supplier *must keep for 3 years
222 Triplicate
Copy 1Brown-Seller/Manufactor/Sender. Copy 2Green-DEA Copy 3-Blue- Pharmacy/Receiver
amiodarone
Cordarone/Pacerone III (K)
carvedilol
Coreg/Coreg CR
timolol/dorzolamide
Cosopt Beta-blocker/CA inhibitor for glaucoma
warfarin
Coumadin/Jantoven
Combat Methamphetamine Epidemic Act
Covers: pseudoephedrine, ephedrine, phenylpropanolamine (vet use), norpseudoephedrine (not available in US) Document sales, qty limits, keep behind eh counter or in locked cabinet Limits - 3.6gm/day - 9gm/30 days - 7.5gm/30 days if mail order - 3 boxes/transaction Pt needs photo ID or passport 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 Keep records for 2 years
losartan
Cozaar
rosuvastatin
Crestor High 20-40mg
duloxetine
Cymbalta
liothyronine
Cytomel
misoprostol
Cytotec Gastro-protective
What are some P-GP [P-Glycoprotein] substrates?
DDR Console digoxin, dabigatran, rivaroxaban, colchicine
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
Controlled Substances: *DEA forms* (p. 82)
DEA form: *224* - Registration form for retail/hosptial (to get DEA number) *225* - Registration for manufacturers (to get DEA number) *363* - Registration for narcotic tx programs *222* - Ordering Sched I and II drugs *106* - Reporting theft, or significant loss of controlled substances *41* - record of controls destroyed
Checking Validity of a DEA Number (p. 91)
DEA number 2 letters followed by *7 numbers* (like a phone number) *Last digit = check digit* *First letter*: identifies the type of practitioner or institution A/B/F/G: Hospital/Clinic/Practitioner/Teaching Institution/Pharmay M: Mid-level practitioner (PA, NP, Optometrists) P/R: manufacturer/distributer/Researcher *Second Letter*: First letter of the Prescriber's first *last name* If authorized to prescribe narcotics (buprenorphine etc) for opioid addiction tx the 1st letter will be replaced by an *"X"*
Emergency Filling of *Schedule II Drugs* (p. 103)
DEA permits *oral orders* for schedule II drugs requiring immediate administration The Rx *must* be reduced to *writing* and contain all necessary info *except for prescriber's signature* Quantity: must be the *minimum necessary* until a prescription can be written or electronically transmitted *amount is up to the pharmacist's professional judgement* Prescriber must provide an *original prescription* by the *7th day following the fill date* and must include on the face of the Rx: 1. "Authorization for Emergency Dispensing" 2. Date of the oral prescription Pharmacist must *attach* the written/electronically submitted Rx to the oral Rx that was reduced to writing If *original Rx* NOT received w/in 7 days 1. report to the California BUreau of Narcotic enforcement w/in *144 hours*
DMSO Mercury
DMSO label: Can be hazardous, keep away from children label Mercury: use earth911.com, open all windows and doors and leave
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
Keeping Track of all Controlled Refills
Daily hard copy printout of refills with a signature and date of all the pharmacists involved Printout must be provided to the pharmacy within 72 hours of the date on which the refill was dispensed Or: Daily bound logbook documenting each day's refills with pharmacist initials
flurazepam
Dalmane
Enablex
Darifenacin
propoxyphene/acetaminophen
Darvocet Is this even on the market? CIV-federal
Controlled Substance Utilization Review and Evaluation System *CURES*
Database for all *Schedule II-IV* yes thats right *schedule 2 - 4* Pharmacies report to CURES on a *weekly* basis - every 7 days!!!! *ALL* pharmacists MSUT be registered to access CURES!!!!!!
When filling emergency refill for controlled substance, what record should be noted on the back of the prescription?
Date of Emergency Fill Prescriber was not reached Reason why it should be filled
Label of unit dose prepared by a centralized hospital packaging pharmacy
Date when it prepared BUD Drug name Quantity of each active ingredient Special storage and handling Lot number assigned by pharmacy Name of pharmacy
oxaprozin
Daypro PO MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 1200mg/day - 600mg in renal/HD SE: Edema, confusion, GI, increase LFTs *NSAIDs increase risk of serious CV events Stor/Stab: protect, keep bottle air-tight
methylphenidate
Daytrana/Ritalin/Concerta (ER)
SB 493
Declares pharmacist as providers. Establishes advanced practice pharmacist.
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.
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
prednisone
Deltasone
torsemide
Demedex Loop
meperidine
Demerol PO, IM, Subq, IV(diluted) MOA: Inhibits pain pathway at opioid receptors, generalized CNS depression Dose: 50-150mg q3-4hr *Avoid use in renal impairment SE: circulatory/resp depression, CNS, pruritis, N/V *Taper off long-term therapy CII
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
valproic acid/divalproex sodium
Depakene/Stavzor/depakote 1st-line for absence petit-mal, atypical absence, myoclonic, atonic, and generalized tonic-clonic seizures; ok for partial seizures
valproic acid
Depakote Sprinkle/Depakote ER/Depakote
Certified Nurse-Midwife (CNM) Prescribing Authority
Dependent authority - All OTHER non-controlled and CII-CV* *Must register with DEA for CS
Nurse Practitioner (NP) Prescribing Authority
Dependent authority - All OTHER non-controlled and CII-CV* *Must register with DEA for CS
Physician Assistant (PA) Prescribing Authority
Dependent authority - All OTHER non-controlled and CII-CV* *Must register with DEA for CS
medroxyprogesterone
Depo-Provera/Provera
trazodone
Desyrel Serotonin receptor antagonist/reuptake inhibitor
tolterodine
Detrol/Detrol LA Over-active bladder
Steroid conversion
Dexa = Beta 0.75 Methylprednisolone = triamcinolone 4 Prednisolone = Prednisone 5 Hydrocortisone 20 Cortisone 25
Precedex
Dexmedetomidine alpha 2 agonist
glyburide
Diabeta/Glynase/Micronase Sulfonylurea
detidronate
Didronel
adapalene
Differin Vitamin A derivative
fluconazole
Diflucan
phenytoin
Dilantin/Phenytek Ok for partial and generalized tonic-clonic seizures. Mix in NS only Max infusion of 50mg/min
isosorbide dinitrate
Dilatrate SR/Isordil Vasodilator
hydromorphone
Dilaudid/Exalgo PO(tab,soln), IV MOA: Inhibits pain pathway at opioid receptors, generalized CNS depression Dose: 2-8mg q4-6hr-tab; 0.2-1mg q2-3hr-IV SE: Resp depression, flushing, CNS, pruritus, GI, decreased UOP Stor/Stab: Protect from light CII
valsartan
Diovan
valsartan/HCTZ
Diovan HCT
Dea form 41
Disposal of control substances 3 copies all to DEA
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.
oxybutynin
Ditropan/Ditropan XL/Oxytrol/Gelnique Over-active bladder
chlorothiazide
Diuril Thiazide
Pre/Post Dating
Do NOT do it Must date and sign on date when issued
Out of Country Prescribers
Do NOT fill
Self assessment
Do before July 1st of every odd-numbered year w/in 30 days of becoming PIC Keep 3 years Notice to consumers, point to your language, all 18point name tags, name and license
Lasix
Do not refrigerate Protect from light Photosensitivity
Dilantin
Do not refrigerate Saline Filter
Drugs incompatible with sodium bicarbonate?
Dobutamine Amiodarone [must be diluted with some D5W] Isoproterinol Calcium Chloride Epinephrine/NorEpi "Baking Soda doesn't go with DA ICE"
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
Physical Assessment (p. 70)
Documentation is *REQUIRED*
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
Inspector
Doesn't need permit or to be a RPH Give original, take photocopy with receipt 30 days to appeal citation (but just fix it)
methadone
Dolophine/Methadose/-Intensol PO(tab,susp) MOA: Inhibits pain pathway at opioid receptors, also has NMDA receptor antagonism Dose: Detox-10mg increment;Pain-2.5-10mg q8-12h *Dose reductions <10% every 10-14d SE: CNS, resp depression, GI, urinary retention CII
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
What is Restless Legs Syndrome and treatment?
Dopamine deficiency in basal ganglia Mirapex [pramipexole] or Requip [ropinirole] immediate release Neupro [rotigotine] patch Horizant [gabapentin]
ergocalciferol (Vit D2)
Drisdol
Multaq
Dronedarone Class - 3
Traditional Compoudning; 503A (p. 49)
Drug Quality and Security Act (*DQSA*) - section *503A* compound a drug when the health needs of a pt cannot be met by an FDA-approved medication 503A permits a pharmacy to prepare *small batches* of a compounded preparation in *advance* if the dispensing hx and the store supports the need Pharmacists CAN also furnish compouds for *office use* by a prescriber as long as it is NOT more than a *72-h (3-day) supply* Must attribute the correct BUD for these compounded drugs
pioglitazone/glimepiride
Duetact TZD/sulfonylurea
bisacodyl
Dulcolax
mometasone/formoterol
Dulera
lactulose
Duphalac/Chronulac
fentanyl
Duragesic/Actiq/Sublimaze/Onsolis/Fentora/Lazanda/Subsys/Abstral IV, IM, PO-all the routes MOA: Receptors in CNS-increases pain threshold, alters pain reception Dose: Reduce patch by 50% in mild-mod renal impairment SE: CNS, dehydration, GI, weakness *Caution in resp issues *Elderly more sensitive CII Stor/Stab: Protect from light-IV
cefadroxil
Duricef 1st gen PO
isradipine CR
DynaCirc DHP
dicloxacillin
Dynapen
triamterene
Dyrenium Potassium-sparing diuretic
prednisolone
Econopred Plus/Pred Forte
azilsartan
Edarbi
ethacrynic acid
Edecrin Loop
How often does a hospital need to perform an inventory of schedule II drugs?
Effective April 1, 2018, pharmacies must perform an inventory of schedule II drugs every quarter.
venlafaxine
Effexor/Effexor XR
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
amitriptyline
Elavil
Parkinson MAO-B drugs
Eldepryl - selegiline Zelapar ODT - selegiline Azilect - rasagiline
pimecrolimus
Elidel Immunosuppressive - eczema
permethrin 5%
Elimite Body lice
ulipristal
Ella
Types of Emergency Contraception
Ella = ulipristal Plan B = levonorgestrel
mometasone
Elocon
Pharmacist can prescribe:
Emergency Contraception Hormonal contraception Travel Medicine Routine immunizations Naloxone Nicotine replacement.
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
selegiline
Emsam/Eldepryl (PD) MAOI Patch only for depression
darifenacin
Enablex Anti-muscarinic Over-active bladder
etanercept
Enbrel SC
Dispensing Aid-in-dying drugs (p. 108 - 109)
End of Life Option Act (June, 9th 2016) Death with dignity, Physician-assisted suicide Pts who wish to receive aid-in-dying *MUST* 1. 18+ years 2. California resident 3. Mentally competent (capable of making and communicating healthcare decisions) 4. diagnosed w/ terminal illness (die w/in 6 months) confirmed by *2 physicians* Procedure: 1. Oral request to physician 2. After 15 days another oral request 3. Written request (can occur anytime after the 1st oral request) 4. After the physician receives *all 3 requests* he can now write the prescriptions 5. Pt picks up meds from pharmacy 6. Pt must complete *final attestation form* (given by the attending physician) within 48 hours before taking the medication Drugs often used 1. Secobarbital 2. Pentobarbital 3. anti-emetic 1 hour prior If a pharmacist declines to furnish d/t conscientious objection, they should refer the patient to another pharmacist/pharmacy
oxycodone/acetaminophen
Endocet/Roxicet/Tylox/Percocet Opioid CII
Hepatitis B
Engerix-B/Recombivax HB
guaifenesin/phenylephrine
Entex LA
guaifenesin/pseudoephedrine
Entex PSE
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
epinephrine
Epipen, Epipen Jr
lamivudine
Epivir NRTI
lamivudine/abacavir
Epzicom NRTI, NRTI
erythromycin
Ery-Tab
lithium
Eskalith/Lithobid
What toxicity from Edecrin?
Ethacrynic Acid Ethacrynic... Ototoxic
Complete CIII-CV inventory
Every 2 years
How often to complete? Controlled substances inventory
Every 2 years
Pharmacist CE (30 hours in 2 yrs)
Every 2 years, *EXCEPT* first cycle
Complete RPh CE (30hrs) when
Every 2 years, except first cycle
How often to complete? Pharmacist continuing education (30 hours)
Every 2 years, except first cycle
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
Pharmacy Self Assessments
Every odd year on July 1st
How often to complete? Self-assessment form
Every odd-numbered year before July 1st
Self-assessment form
Every odd-numbered year before July 1st
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
Oral loop diuretic conversion
Everybody F$#ked That B!tch E -- Ethacrynic Acid = 50mg F -- Furosemide = 40mg T -- Torsemide = 20mg B -- Bumetanide = 1mg
Auxiliary Labels
Evidence-based and written in simple language
raloxifene
Evista SERM
Exalgo vs Dilaudid C2
Exalgo ER is extended release formulation of Dilaudid
Written Prescriptions (California Security Forms) for Controlled Substances
Exceptions: 1. for terminally ill pt 2. emergency use 1. Schedules *II - V* MUST be written on California security prescriptions 2. 6 quality check off boxes: for quantity of med 3. Preprinted name, category of licensure, license number, federal controlled substance reg. number of the prescribing practioner 4. check boxes shall be printed on the form the so prescriber can indicate the number of *refills* ordered 5. Origin date of the prescription
rivastigmine
Exelon AChEi
valsartan/amlodipine
Exforge
Expiration Dates (p. 28)
Expiration date can be: 1. expiration date on the manufacturer's container 2. 1 year from the date the drug is dispensed Noted month and year (i.e. 3/2017)
outsourcing facilities must register with?
FDA and the CA board of pharmacy
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
famciclovir
Famvir zoster, simplex 2nd-line
iloperidone
Fanapt
Promoting Public Health: *Medicare* (p. 78)
Federal health insurance ≥ 65 yrs < 65 + disability or ESRD *Part D star ratings based on:* 1. CMR/MTM 2. adherence to non-insulin DM meds, statins, RAAS inhibitors (ACEI/ARBs) 3. Appropriate of avoidance of high risk meds in pts 65+ yrs (*BEERs Criteria*) 4. Ensuring *statin* use in pts w/ DM age 40-75 yrs old
piroxicam
Feldene PO MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 20mg daily - not rec in renal impairment SE: Edema, dizziness, rash, GI *NSAIDs increase risk of serious CV events
letrozole
Femara
Schedule III
Fiorcet (not scheduled federally) Androgel APAP + Codeine Buprenorphine ketamine
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
metronidazole
Flagyl
Photosensitivity
Flagyl INH Retinoids Ritonavir & a few other HIV drugs Sulfa abx Tetracyclines NSAIDs Diuretics (FIRRST ND)
Discoloration
Flagyl Levodopa Entacapone Macrobid Phenazopyridine
cyclobenzaprine
Flexeril PO - Skeletal muscle relaxant MOA: Centrally acting, related to TCAs, reduces tonic somatic motor activity Dose: Cap-15mg daily; Tab-5mg TID; max 2-3wks SE: Drowsiness, dizziness, xerostomia, HA - monitor for s/sx of serotonin syndrome
tamsulosin
Flomax
fluticasone
Flonase/ Veramyst Nasal spray
fluticasone
Flovent MDI
ofloxacin
Floxin Otic
Do NOT Refrigerate AntiBiotics
Fluoroquinolones azithromycin susp, clarithromycin susp - Suspension thickens and tastes bitter clindamycin linezolid - IV form will crystallizes but redissolve at room metronidazole Bactrim "Can't Let Bactrim Collect Mold in A Fridge"
infuenza
Fluzone
dexmethylphenidate
Focalin
folate, cyanocobalamin, pyridoxine
Foltx Vitamin
folic acid
Folvite
Medicare Part D
For 65+YO, <65 w/ disability, or ESRD
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
OD
For codeine- or hydrocodone-containing products, can prescribe a max 3-day supply (license # T)
A person wants to quit smoking by starting NRT. Pharmacy asks question before furnishing the treatment and finds out that patient has medical history of stable angina and had recent heart attack within the last 2 weeks. Can NRT be still furnished?
For patients with recent heart attack, history of arrhythimia, or unstable angina, YES NRT can be furnished WITH CAUTION AAAAAND refer patient to a provider. If patient is pregnant, however, do not furnish.
6. Order and interpret tests
For purposes of monitoring and managing efficacy and toxicity of drug therapies, in coordination w/ pt's PCP or diagnosing prescriber
formoterol
Foradil
Stealing
Form 106 (online) DEA: 1 day 14 days to inform board (if controlled 1 day) Any other type of lass: 30 days
Ordering CII?
Form 222 CSOS (Controlled Substance Ordering system )
Ordering Controlled medications
Form 222 - schedule II drugs Can also order CII via *CSOS* --controlled Substance Ordering System CSOS is the electric equivalent of form 222
When a pharmacy transfers C II to a reverse distributor for destruction, what form is formed by whom?
Form 222 filled by reverse distributor where pharmacy keeps copy 1 and 2 as a "supplier" Form 41 is formed by the reverse distributor.
Form 222
Form 222 goes with each: 1. distribution 2. purchase 3. Transfer used when schedule 2 drugs go from: 1. wholesaler to pharmacy 2. pharmacy to another pharmacy 3. pharmacy to DEA sanctioned disposal facility 4. pharmacy back to wholesaler (returns) whoever receives the CII *keeps copy 3* and *sends copies 1 & 2* to the supplier whoever is supplying the CII's (Generally the wholesaler) *sends copy #2* to the DEA If pharmacy was returning drugs to the wholesaler the pharmacy would keep copy #1, send #2 to the DEA, and give the wholesaler copy #3 Colors of the form: 1. 1st = brown 2. 2nd = green 3. 3rd = blue *purpose of the 222 form* --document every distribution, purchase, or transfer of schedule II drugs
Initial DEA forms 222 can be requested on what form?
Form 224 which is application for new reigstration. Once a registrant has received a DEA registration number, additional DEA forms 222 may be ordered on the DEA website.
ceftazidime
Fortaz 3rd gen IV/IM
teriparatide
Forteo Recombinant PTH
alendronate/cholecalciferol
Fosamax + D
alendronate
Fosamax/Binosto
foscarnet
Foscavir CMV, simplex, varicella-zoster
lanthanum
Fosrenol
dalteparin
Fragmin LMWH
Storage Temps
Freezer -50 - -15°(-58 - +5°F) Regrigerator 2-8°C (35-45°F) Room Temp 20-25°C (68-77°F)
HPV
Gardasil
What is unique about 3rd generation cephalosporin drug names?
Generic names end in "me, ne, ir" roc
ziprasidone
Geodon Weight-neutral
SC Vax
Given into fatty tissue, usually fatty tissue above triceps - 5/8inch - 23-25 gauge - 45 degree angle
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
metformin
Glucophage/Glucophage XR/Fortamet/Glumetza
glipizide
Glucotrol Sulfonylurea
glyburide/metformin
Glucovance Sulfonylurea/biguanide
Rubinol
Glycopyrrolate anticholinergic Indication: stops drooling, treat bradycardia
miglitol
Glyset Alpha glucosidase inhibitor
Patient-Delivered Partner Therapy
Gonorrhea: Ceftriaxone 250mg IM once + Chlamydia: Azithromycin 1g once Trichomoniasis: Metronidazole 2g po once
HOURS 48 hours. When a nurse enters an order, the prescriber has ___ hours to physcially
HOURS 12 hours. A pharmacy that issues a recall notice about its **sterile compounded drug** product must contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours if the recall notice. If it involves serious side effects such as death or the recalled drug was dispensed or is intended for use, in CA. 24 hours. All actions related to test ordering, interpretation, and management, including changes in drug treatment, must be documented within 24 hours in a system accessible to the health care members.b 48 hours. When a nurse enters an order, the prescriber has 48 hours to physically or electronically sign the order. 48 hours. Mobile pharmacy during declared emergency ceases activity within 48 hours after the emergency is over. 48 hours off-storage info must be retrievable within 48 hours 72 hours Pharmacies can furnish compounded products to prescriber for "office use" or for idstribution of no more than 72 hour supply.
triazolam
Halcion
haloperidol
Haldol 1st gen antipsycotic High potency
Optometrist
Has a T at end of their license number 12345-T Glaucoma if pt >18yo 3 weeks antivirals 10 days acyclovir 3 days of codeine/hydrocodone
Interns can do anything a pharmacist can do except...
Have a key to the pharmacy.
Hepatitis A
Havrix
USP 800 is...?
Hazardous Drugs.
Can you mix a Statin drug with gemfibrozil?
Hell no!!
Medicaid & Medical
Helps low income, is medicare and Medicaid Medical is welfare. All rx must be on tamper resistant pad
heparin
Hep-Lock
C1 drugs
Heroin Marijuana MDMA LSD GHB Mescaline Peyote
Direct Factor Xa inhibitor monitoring Xarelto Eliquis [apixaban] Savaysa [edoxaban]
Hgb, Hct LFT SCr
Pradaxa [dabigatran] Monitor Oral Direct Thrombin Inhibitor
Hgb, Hct SCr
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*
Centralized Hospital Packaging
Hospital Pharmacy can perform centralized packaging for the pharmacy's hospital and *1-more* general acute care hospital under *common ownership* located *within 75-mile radius* Centralized pharmacy can *prepare and store* a limited quantity of unit dose drugs in advance of a pt-specific Rx in amounts necessary to ensure continuity of care Unit dose containers are: 1. *non-reusable*, 2. designed to hold a quantity of drug intended for direct oral admin as a single dose 3. unit dose packaging can be done by manufacturer or by pharmacy prepared from multiple dose containers in the pharmacy
Maintain x least 7 yrs
Hospital pharmacy chart order records for controlled substances
insulin lispro
Humalog
insulin NPH/insulin lispro
Humalog 75/25 / Humalog 50/50
adalimumab
Humira SC
insulin NPH/insulin regular
Humulin 70/30 / Novolin 70/30
lente, insulin zinc
Humulin L/Novolin L
insulin NPH
Humulin N/Novolin N
insulin regular
Humulin R/Novolin R
Lortab, Lorcet, Vicodin C2
Hydrocodone
hydrocodone ER
Hysingla ER/Zohydro ER/Vantrela ER PO MOA: Opioid receptors in CNS-inhibits pain pathway; generalized CNS depression Dose: max >80 or >120; once or BID SE: Sedation, pruritus, GI *Taper off CII
terazosin
Hytrin
losartan/HCTZ
Hyzaar
Tussinex schedule
II
CS inventory count
II: must be exact count regardless of tablet numbers III,IV,V : opened: <1000 can be estimated. unopened: estimation is fine.
Tramadol in California is schedule
IV FOUR.
Ofirmev
IV formulation of acetaminophen
Caldolor
IV formulation of ibuprofen
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
IV:PO ratio 1:1 drugs
IV:PO Ratio is 1:1 Fluconazole Phenytoin Valproic Bactrim, Flagyl [metronidazole] Clindamycin, Azithromycin, Levofloxacin, Linezolid "BF CALL to talk 1 to 1" Famotidine Lorazepam Metoclopramide Rifampin
IV:PO ratio 1:2 drugs
IV:PO Ratio is 1:2 Furosemide Levothyroxine Haldol
Minors
If Pt under 15 can share with parent (assuming they pay for their health insurance and are their representative) If the child pays themselves then we dont share
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.
Pt identification before dispensing controlled substances (p. 104)
If an Rx is orally or electronically transmitted for a controlled substance the patient *must provide proof of identity* if pt is unknown to the pharmacy staff
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
Physician assistant/Certified Nurse Practitioner
If writing for controls they are still under protocol, but must have their signature on the rx.
Filling for dead prescriber Psyciatrist vs Psychologist
If you don't know its fine, if you do you can fill a small amount if in patients health interest. Psychiatrist can prescribe (MD), psychologist cannot
isosorbide mononitrate
Imdur ER/Ismo/Monoket Vasodilator
sumatriptan
Imitrex Serotonin receptor antagonist
What are some -triptan for migraines?
Imitrex [sumatriptan] Zomig [zolmitriptan] Maxalt [rizatriptan] Relpax [eletriptan]
Report bankruptcy, insolvency, receivership by
Immediately
Reporting Time Period? Loss/theft of controlled drugs
Immediately
Recalls
Immediately remove them all and contact wholesaler for directions Notify Patients and find alternatives
1 of the 30 Pharmacist CE hours must be in....
Immunizations and Vaccines
loperamide
Imodium
azathioprine
Imuran PO/IV
Tech-Check-Tech program
In acute care hospitals Must be previously reviewed and approved by RPH
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
Dentist Prescribing Authority
Independent authority *Must register with DEA for CS
MD/DO Prescribing Authority
Independent authority *Must register with DEA for CS
Podiatrist (DPM) Prescribing Authority
Independent authority *Must register with DEA for CS
Vet (DVM) Prescribing Authority
Independent authority *Must register with DEA for CS
Registered Pharmacist (RPh) Prescribing Authority
Independent authority, 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-controlled and CII-CV* *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 - All OTHER non-controlled and CIII-CV* *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
propranolol
Inderal/Innopran XL some antiarrhythmic class I (Na) action
indomethacin
Indocin/Tivorbex PO (IR, ER), PR, IV(over 20-30min) MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 25mg 2-3x/d, 75mg/d; max of 200mg/150mg *Not rec in renal failure SE: HA, GI, dizziness, swelling *NSAIDs increase risk of serious CV events
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
PIC
Inform Board of pharamcy in writing w/in 30 days, can be 2 pharmacies but must be w/in 50 miles of each other. Must do C 2 inventory w/in 30 days of becoming PIC Temp PIC lasts 120 days If BOP says no you have 15 days to find replacement
naloxone injection (p. 65)
Inject *1 mL* into upper arm or thigh muscle if no reaction in *3 minutes* inject another dose
Injection card system
Injection of control substance from standing order
Classes with MedGuides
Insomnia drugs Some antipsychotics: Abilify, Seroquel LABAs Antidepressants ADHD drugs NSAIDs DM drugs Retinoids Most antiarrhythmics: amiodarone
eplerenone
Inspra Aldosterone antagonist
eptifibitide
Integrilin GP IIb/IIIa inhibitor
paliperidone
Invega
What to do when there is a Med error
Investigation must occur within 2 business days after error was discovered using root cause analysis to identify the cause - Records of the investigation kept for 1 year inside the pharmacy
saquinavir
Invirase PI Take with food
Permit to operate
Issued every year
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.
Refillable as needed as needed for C III - IV prescription?
It means one refill.
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.
sitagliptin/metformin
Janumet DPP4i/biguanide
Janunia [sitagliptin] side effect vs other -gliptins?
Janunia [sitagliptin] has acute pancreatitis. Other -gliptins has hepatotoxicity and heart failure. Drugs in the -gliptin class are weight neutral.
sitagliptin
Januvia DPP4i
potassium chloride
K-DUR/Khlor-con/Micro-K
morphine ER
Kadian/Avinza/MS Contin Dose: up to 90-120+ in tolerant pts *Avinza/Kadian caps can be opened SE: CNS, C/N/V, urinary retention, edema CII
lopinavir/ritonavir
Kaletra PI, PI
ethinyl estradiol/desogestrel
Kariva/Apri
How do you store [Pradaxa] dabigatran?
Keep in original container. Discard 4 months after opening the bottle. Do NOT put in NG tube
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
Furnishing Self-administered Hormonal Contraceptives (p. 67)
Keep records for *3 years* Formulations: Pill, patch, ring, injection Self-assessment screening form: 1. initially 2. Annually 3. any major recent health change *measure pt's seated BP if combined (estrogen and Progestin) hormonal contraceptives are being used* *Must give 3 fact sheets* 1. birth control guide 2. pt product information 3. administration fact sheet specific for their formulation they are receiving
cephalexin
Keflex 1st gen PO
What are reversible P2Y12 antagonists?
Kengreal [cangrelor] Brilinta [ticagrelor]
anakinra
Kineret SC
clonazepam
Klonopin
granisetron
Kytril 5HT3 antagonist (N/V)
lamotrigine
Lamictal/Lamictal ODT/Lamictal XR 1st-line for partial, atypical absence, myoclonic, atonic, and generalized tonic-clonic seizures
terbinafine
Lamisil Athlete's foot
digoxin
Lanoxin/Digitek/Lanoxicaps Class V?
insulin glargine
Lantus
furosemide
Lasix Loop
Selling Controlled Substances (p. 107)
Left off top of 107
What is Left Shift? What is Right Shift?
Left shift refers to increase in New Bands to fight bacterial infection [High WBC means new infection and Low WBC means it can't keep up with infection] Right shift seen by high lymphocytes and monocytes indications viral infection
C II Partial Fills
Legal, but the remaining quantity must be filled within 72 hours or the remainder is lost *also ok if terminally ill pt. For them, you can partially fill in increments up to 60 days
fluvastatin
Lescol/Lescol XL Low-Mod 20-80mg
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,
levofloxacin
Levaquin
hyoscyamine
Levbid/Levsin SL Antimuscarinic
insulin detemir
Levemir
vardinafil
Levitra
levothyroxine
Levoxyl/Synthroid/Levothroid
escitalopram
Lexapro
chlrodiazepoxide
Librium
lidocaine
Lidoderm Topical patch Can be cut
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.
baclofen
Lioresal PO, Intrathecal Muscle relaxant/antispasmotic MOA: Inhibits transmission of reflexes at the spinal cord Dose: Initial: 5mg TID; usual 40-80mg 3-4x/day SE: Hypotonia, drowsiness, N/V, HoTN
atorvastatin
Lipitor Mod-High 10-80mg
Substituting Biologicals (p. 44)
Lists of Licensed Biological Products w/ Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations aka *The Purple Book* Only 2 biologic Biosimilars approved: 1. Neupogen biosimilar: Filgrastim-sndz (Zarxio) 2. Remicade biosimilar: infliximab-dyyb (Inflectra) May make this substitution unless the "biosimilar costs more" or the physician says no Must communicate to pt and physician that the pt got the biosimilar
pitavastatin
Livalo Low-Mod 1-4mg
Drug Storage for Controlled Drugs
Locked cabinet or dispersed throughout other drug stock (on shelves)
diphenoxylate/atropine
Lomotil
minoxidil
Loniten Direct vasodilator
gemfibrozil
Lopid
metoprolol
Lopressor/Toprol XL
hydrocodone/acetaminophen
Lortab/Lorcet/Vicodin/Norco/Vicoden ES PO MOA: Inhibits pain pathway at opioid receptors/inhibits synthesis of prostaglandins Dose: 2.5-10mg/300-325 q4-6h SE: Resp failure, CNS, pruritus, N/V *Taper off CII
benazepril
Lotensin
benazepril/HCTZ
Lotensin HCT
amlodipine/benazepril
Lotrel DHP/ACEi
omega-3 fatty acids
Lovaza
enoxaparin
Lovenox
Sterile BUD
Low risk 48h rt 14d fridge 45d frozen Medium risk 30h rt 9d fridge 45d frozen High risk 24h rt 3d fridge 45d frozen Immediate use=w/1h
ethinyl estradiol/norgestrel
Low-Ogestrel
loxapine
Loxitane 1st gen antipsycotic Medium potency
indapamide
Lozol Thiazide-like diuretic
bimatoprost 0.03%
Lumigan PG analog
eszopiclone
Lunesta
fluvoxamine
Luvox/Luvox CR
pregabalin
Lyrica
Schedule 5 drugs...
Lyrica Lomotil codeine containing cough syrups.
mid level practitioner DEA
M
MMR
M-M-R II
Valid C 2
MD information must be preprinted Date must be written by MD Name/Address of Patient Prescribers license and DEA
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
Independent authority prescribers
MD/DO dentist podiatrist (DPM) veterinarian (DVM) optometrist (DO) ** naturopathic doctors (ND) **
DEA form 225 is registration for?
MFG, distributer
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
nitrofurantoin
Macrobid/Macrodantin
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
Letter T at the end of the license # on an optometrist...
Max 3 day supply of codeine-containing combinations and hydrocodone-combinations.
Medication Dispensing at ER
Max 72 hour supply, no pharmacy in hospital or around/open(30 miles)
pirbuterol
Maxair autohaler MDI
rizatriptan
Maxalt Serotonin receptor antagonist
4th gen cephs
Maxipime
cefepime
Maxipime 4th gen IV
triamterene/HCTZ
Maxzide/Dyazide Potassium-sparing diuretic/Thiazide
Isotretinoin
MedGuide REMS Blurred vision Photosensitivity
NSAIDs
MedGuides Photosensitivity CI in CrCl < 30
Repackaging previously Dispensed drugs into blister packs (p. 49)
Medication blister pack aka bubble blister pack aka medication pill card any pharmacy providing repackaging services needs Policy and Procedures in place for the repachaging proce MUST label the repackaged meds w/ 1. All info required for an Rx label 2. Name and address of the pharmacy that initially dispensed the drugs to the pt 3. Name and address of pharmacy repackaging the drugs (if different from above)
methylprednisolone
Medrol
cefoxitin
Mefoxin 2nd gen IV/IM
thioridazine
Mellaril 1st gen antipsychotic Low potency
glipizide/metformin
Metaglip Sulfonylurea/biguanide
psyllium
Metamucil
metronidazole
Metrogel
lovastatin
Mevacor Low-Mod 10-80mg
calcitonin
Miacalcin
Name 2 calcitonin drugs
Miacalcin Fortical nasal [both have poor benefits]
calcitonin
Miacalcin/Fortical (nasal)
telmisartan
Micardis
hydrochlorothiazide (HCTZ)
Microzide Thiazide
amiloride
Midamor Potassium-sparing diuretic
magnesium hydroxide
Milk of Magnesia
prazosin
Minipress
minocycline
Minocin
polyethylene glycol
Miralax/Glycolax
pramipexole
Mirapex DA agonist
molindone
Moban 1st gen antipsycotic Medium potency
meloxicam
Mobic/Vivlodex PO- caps are NOT equal to other PO forms MOA: Cox-1 and -2 inhibitor, antipyretic Dose: Max of 10mg/d-OA; max of 15mg/d-RA *CrCl <20 use not rec SE: Edema, CV, pain, dizziness, GI *NSAIDs increase risk of serious CV events
fosinopril
Monopril
If there is an ADC a PIC must check transactions every
Month
What is Embeda?
Morphine ER + Naltrexone [inner core] - Naltrexone will not release unless someone tries to crush it which releases the naltrexone and prevents the high
What is unique about 2nd generation cephalosporin drug names?
Most starts with "Cef" except Mefoxin and Zinacef rox
ibuprofen
Motrin/Advil/Caldolor PO(tab/susp), IV(must be diluted-D5W/NS/LR) MOA: COX-1 and -2 inhibitor; antipyretic, anti-infla Dose: 400-800mg q4-6hr; max of 3200mg/d *Pts should be well hydrates prior to IV admin SE: Edema, rash, GI, increase LFTs *NSAIDs increase risk of serious CV events
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
HIPAA requires SITE SPECIFIC privacy notices
Must be give to the pt on the 1st day service is provided NO requirement for future signatures If pt refuses to sign: 1. Pharmacy canNOT refuse services to pt 2. Just document pt's refusal This signature for the privacy notice MUST be separate from other signatures obtained by the pharmacy
Religious exemption
Must be notified to employer in writing and help patient find it elsewhere
Emergency protocol (p. 58 on bottom)
Must be present if giving injections
Interpretive Services
Must be provided during all hours pharmacy is open, either in person, by pharm staff, or third party interpretive services via phone
Drug-take-back Program
Must be registered with DEA and Board of Pharmacy w/in 30 days If tampered notify board in 14 days
Who can sign the form 222 (p. 87)
Must be signed by the person authorized to sign the registration application (who has been granted power of attorney) signed and dated (#7 in the list) once filled out, the purchaser keeps copy 3 and sends copy 1 (brown) and copy 2 (green) to the supplier Supplier then keeps copy #1 and sends #2 to the DEA
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 w/in 24hrs if both below apply: 1. Use/exposure can cause serious ADR or death 2. Item was intended for use in CA
What if you fail CPJE 4 times?
Must enroll in pharmacy school and complete 16 semester units of additional coursework
P&T comittee
Must have a pharmacist and physitian Policy and procedures
Automated drug delivery
Must have manufacturer, lot, exp, str, dosage, and name If new med, must telecom with patient Register with board w/in 30 days Pharmacist restocks, unless removable pocket, card, drawer, review drugs monthly
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
*Mobile Pharmacy* during a federal, state, local emergency (p. 56)
Must meet all following Reqs 1. mobile pharmacy shares a common owner w/ at leant one currently licensed pharmacy in good standing 2. Maintain records of dispensing 3. Licensed pharmacist on site 4. Security measures in place 5. Mobile pharmacy located *w/IN* the emergency declared area 6. Cease activity w/in *48 hrs* after emergency is over
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
Reporting the loss or theft of controlled substances (p. 107)
Must report significant losses and *all* thefts to the local DEA office using *form 106* within *1 business day* *Within 30 days* of discovery to the state board
Pharmacy Returning CII
Must use DEA 222 acting as supplier
nystatin
Mycostatin
N-acetylcysteine
NAC/Acetadote/Cetylev PO(effervescent,soln) and IV(D5W/SWFI/1/2NS) APAP Antidote/Mucolytic Agent MOA: Hematoprotective/glutathione substitute. Mucolytic action by opening disulfide bonds FDA: 72-hr, 18 dose PO and 21-hr, 3 dose IV regimens SE: Autoimmune, anaphylaxis, urticaria/pruritis, N/V/GI Stor/Stab: IV-room temp, use w/n 24hrs-may turn light pink/purple; effer soln use w/n 2 hours of dissolution
naturopathic doctor license starts with?
NDF
Can you donate controlled substances?
NO
Donating meds for redistributyion (p. 123)
NO *controlled substances* can be donated
Controlled Substance (II) is being transferred from central fill pharmacy to retail pharmacy. Is Form 222 needed ?
NO.
Rx Refills (CII)
NOPE >:O
Incidental Disclosures
NOT part of HIPAA violation
Cesamet C2
Nabilone is an antiemetic from marijuana CII C2
Pseydoephedrine Transaction Requirements
Name Address Date and time of the sale Signature in logbook *keep log book for 2 years
A Valid Prescription must contain....
Name & Address of Patient Drug Name Quantity Directions for use Prescriber (License, DEA, Name, Address) Sign and Date
Prescription label requirements
Name/address of pharmacy Prescriber/Bet name Date of issue/expiration/quantity 12 point font Pt name, med, str, directions=50% of label Even if translated, English must still appear Description of drug RPH initials/tech initials compount/unit dose prep needs lot # Pet: Species and animal name Auxiliary labels required by law Controls must have Opioid label and Caution: No transfer of this med to anyone else Med pakcs require: "store in cool dry place"
memantine
Namenda/Namenda XR NMDA receptor antagonist
naproxen
Naprosyn/Anaprox/Aleve (OTC)/Enova/Equipto(cream) PO(IR, ER), PR MOA: Cox-1 and-2 inhibitor, antipyretic, anti-infl Dose: 500-1000mg/d divided *200mg=OTC *CrCl <30-not rec SE: Edema, dizziness, pruritus, GI *NSAIDs increase risk of serious CV events *Contains sodium
naloxone
Narcan/Evzio Opioid antagonist
triamcinolone
Nasacort AQ Nasal Spray
mometasone
Nasonex Nasal Spray
ethinyl estradiol/northindrone
Necon/Microgestin/FemHRT/Estrostep/Ovcon
WTF is sacubitril and its MOA
Neprilysin is an enzyme that degrades BNP, Substance P and bradykinin Entresto [sacubitril/valsartan] ACE -- STOP 36 hours -- Then start Entresto
alogliptin
Nesina DPP4i
pegfilgrastim
Neulasta GCSF
filgrastim
Neupogen GCSF
Neupogen Neulasta
Neupogen [filgrastim] Neulasta [pegfilgrastim]
gabapentin
Neurontin
Consultation
New Rx gets oral consult. Or on request or if RPh feels necessary OBRA 1990 started this How to use Compliance Storage ADE/DDI Mail order RX: Just need to give them a phone number
Dea form 224
New pharmacy application Form 223 is dea certificate of registration 224a renewal done every 3 years
esomeprazole
Nexium
niacin
Niaspan/Niacor
polysaccharide-iron complex
Niferex Supplement
nitroglycerin
Nitro-Dur/Minitran/NitroBid/Nitroquick/Nitrostat/Tridil Vasodilator
permethrin 1%
Nix Head lice
ketoconazole
Nizoral
Can Prescribers Future Date Controlled Drugs?
No Must write the date that the rx was written and the date that the prescription may be filled
Do all CII require security form?
No - 11159.2 exemption Ok if pt is indicated as "terminally ill" on the prescription. Terminally ill means pt is expected to die within one year If pt is hospice, home health, nursing home, you can also take verbal or fax C-II
CLIA-Waived Tests
No California Dept of Public Health registration required: 1. *Blood glucose* 2. *Hgb A1C* 3. *Cholesterol* *ALL* other CLIA waived tests *do require* CDPH registration
Schedule I Drugs
No accepted medical use - MDMA - Heroin - LSD - Marijuana - Peyote
Rx Refills (Non-CS)
No exp but standard of practice is max 1 year of refills
If sending RX
No indication on the outside as too contents, can be control or non control
100 bed or fewer
No need for full time RPH
Syringes
No records, sell to anyone>18yo
Is number of remaining reills or the initials of the filling pharmacist required to be on the prescription label?
No, since these are already recorded in the system. For rph initial, however, if it was filled by a tech or an intern, Rph initial should be on the label as a final check.
tamoxifen
Nolvadex
Prescribers can self-prescribe..
Non-Controlled substances for themselves.
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. *
How many refills are allowed?
Non-control - infinite, but rx expires after 1 year C II - none C III and IV - 5 refills within 6 months and all refills combined can't exceed a 120 day supply
Transfers
Non-control to CIII-V can only be transferred once unless they share a real-time online patient database Write Void on the hardcopy, record date of transfer and receiving RPh date and address and DEA(Controls) Receiver reduce to writing
Furnish drug from an out-of-state prescriber?
Non-controlled = Yes Controlled = Only if on a CA security form or orally authorized (no CII) *No script from out of the country prescriber
Can we deny patient services to someone who hasn't signed HIPAA?
Nope.
disopyramide
Norpace Ia (fast Na+K)
desipramine
Norpramin
amlodipine
Norvasc DHP
ritonavir
Norvir PI Refrigerate
Class III Recall
Not likely to cause adverse health consequences
insulin aspart
Novolog
insulin NPH/insulin aspart
Novolog 70/30
SB493 (p. 16)
Now can: 1. Administer drugs and biologics 2. Furnish *self-administered* hormonal contraceptives 3. Furnish travel medications 4. Furnish Rx nicotine replacement products 5. Independently initiate and administer immunizations (*> 3 yrs old*) 6. Order and interpret tests
nalbuphine
Nubain Opioid partial agonist
tapentadol
Nucynta CII
mineral oil
Nujol
ethinyl estradiol/etonogestrel
Nuva Ring
armodafinil
Nuvigil
isonizid
Nydrazid (INH)
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
*Internet Prescriptions* (p. 24)
ONLY dispensed to the pt if the prescriber has *PERFORMED* an examination
Can you receive a prescription written on a plain piece of paper, which all the requirements on the paper including prescriber's information, signature, and have contacted the prescriber for the legitimacy?
ONLY if it is written for non controlled subtance.
CII partial fill
OOS=can partial fill as long as balance w/in 72 h if pt requests smaller amount remainder in 30 days or void terminally ill/long term care partial any # of times for 60 days If 60ds but insurance wants smaller, can do 30ins 30 cash etc
one pill levonorgestrel: OTC age and gender restriction
OTC: no age/gender restriction
ofloxacin
Ocuflox
carteolol
Ocupress Beta-blocker for glaucoma
Emergency supply refills
Ok for non-control and CIII-V
Oral Prescriptions for Controlled Substances
Ok for schedules: *III, IV, V* to be taken over the phone pharmacist must *"reduce to writing"* and include all info required for a valid prescription with the exception of: 1. prescriber's signature 2. Prescribers written date
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
Internet Prescription
Okay if prescriber performed an exam
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
simeprevir
Olysio HCV Take with food Anemia
cefdinir
Omnicef 3rd gen PO
Schedule V-III Drugs can be transferred...
Once
How often does each pharmacy submit dispensing data for C II-IV drugs?
Once weekly
Blister packs can be made for patients but no more than...
One-month can be dispensed at a time.
saxagliptin
Onglyza DPP4i
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
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 Prescriptions
Only if from prescriber's office
Faxed CII
Only if pt in SNF, intermediate care facility, home health, or hospice
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
prednisolone
Orapred
DEA form 222
Order transfer and return C-II Green to DEA Brown to shipper Blue stay w/ receiver Retain 3 years
DEA Form 222
Ordering C-I and C-II substances
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
Form 222:
Ordering, distributing, transferring schedule 1 and 2 drugs.
abatacept
Orencia SC/IV
ethinyl estradiol/norelgestromin
Ortho Evra
ethinyl estradiol/norgestimate
Ortho Tri-Cyclen/Trinessa/Tri-Sprintec
ketoprofen
Orudis PO(EC, IR, ER), PR MOA: Cox-1 and -2 inhibitor, antipyretic Dose: 25-50mg 4x/d, 200mg daily *max dose of 100mg/d in severe renal impairment SE: GI, abn LFTs, edema *NSAIDs increase risk of serious CV events Stor/Stab: protect from light
Pharmacist:Staff Ratio
Outpatient 1 pharmacist: 2 interns 1 pharmacist: 2X - 1 techs 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
oxcarbazepine ER
Oxtellar XR 1st-line partial seizures; ok for generalized tonic-clonic
oxycodone ER
OxyContin Opioid - long-acting CII
Statin Conversion mnemonic
P - 2 mg - Pitavastatin R - 5 mg - Rosuvastatin A - 10 mg - Atorvastatin S - 20 mg - Simvastatin L - 40 mg - Lovastatin P - 40 mg - Pravastatin F - 80 mg - Fluvastatin Pharmacists Rock At Saving Lives and Preventing Flu
What are NS only drugs?
P -- Primaxine I -- insulin E -- erythromycin M -- metronidazole A -- ampicillin D -- daptomycin E -- ertapenem F -- fluconazole "salty PIE MADE in Fullerton"
ABX that are safe in Pregnancy?
PCN [including amoxicillin and ampicillin] Cephalosporin Azactam Macrolide [except clarithromycin Cat C] clindamycin metronidazole All of page 1 except Primaxin [imipenem/cilastatin]
What "mabs" are used to lower LDL?
PCSK9 inhibitor Praluent [alirocumab] Repatha [evolocumab]
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
DDI with plavix
PPI and cimetidine are CYP2C19 inhibitor Plavix is a prodrug
PRN refills
PRN refill can be filled after 1 year at pharmacist discretion if pt harm is possible
propylthioruracil
PTU
Delivering Controlled Substances to Patients (p. 104)
Packaging standards must be met 1. Rx placed in a plain outer container or securely wrapped in plain paper 2. Rx label contains the name and address of the --pharmacy --practitioner --or other person *dispensing* the medication *Can mail scheduled and non scheduled drugs*
nortriptyline
Pamelor
A pharmacy may only use 1 of 2 systems for storage and retrieval of prescription refills info of schedule III-IV controlled substances (p. 101 bottom)
Paper *OR* Electronic can*NOT* use both *Paper* On the back of the Rx must write: 1. Pharmacists initials 2. date dispensed 3. amount dispensed (if not indicated, it is assumed that the pharmacist refilled for the full amount on the refill) *Electronic* 1. Daily hard copy printout of refills for controls, with the signature and date of *all the pharmacists* involved in dispensing 2. This printout out must be completed and provided to the pharmacy w/in *72 hours* of the date the controls were filled 3. a log book is kept documenting each day's refills
Partial fills for Schedule II drugs (p. 102)
Partial fill for CII permissible if: 1. pharmacist is out of stock 2. Rx is for terminally ill pt 3. Rx is for SNF Pharmacist must fill the remainder w/in *72 hours* or the remainder is *lost* and the prescriber must be notified The prescriber may decide to write another Rx for the remainder of the CII *For terminally ill or SNF pts* Pharmacist can partially fill Rx's in increments for up to *60 days* from when the Rx was written
When cancelling or voiding copy2, can supplier void partially? or is it all or nothing?
Partial void of form 222 is possible by notifying the purchaser. (vice versa, where purchaser cancelling the order partially or full is also possible.)
olopatadine
Patanol/Patady
paroxetine
Paxil/Paxil CR/Pexeva
peginterferon alfa 2a & 2b
Pegasys & PegIntron
Refrigerated antibiotic suspensions
Penicillin V Vantin (cefpodoxime) Ceftin (cefuroxime) Benzamycin Erythromycin/sulfisoxazole (Pediazole) Amoxicillin Keflex (PVC BEAK)
famotidine
Pepcid H2RA
bismuth subsalicylate
Pepto-Bismol/Kaopectate
oxycodone/aspirin
Percodan Opioid CII
chlorhexidine
Peridex
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.
Drug Addiction Treatment Act of 2000 (p. 105)
Permits practitioner to prescribe or dispense *schedules III, IV, V* to treat opioid addiction *outside of opioid tx clinics* Drugs permitted to use: 1. Buprenorphine +/- Naloxone (*Suboxone and Subutex*) Buprenorphine allows for expended access of addiction tx beyond methadone clinics since tx can take place in a prescriber's office Naloxone is used to block the effects of other opioids if taken concurrently with Buprenorphine + Naloxone combo *DATA Waiver* 1. requires practitioner Training 2. DEA number changes the 1st letter for an *"X"* = Unique Identification Number
dipyridamole
Persantine
Refusal to dispense based on religious, moral, or ethical beliefs (p. 56)
PharmD can refuse but 1. must have previously notified his/her employer 2. written protocols in place to pt has timely access Options: 1. another pharmacist dispenses 2. refer to a nearby pharmacy where they can get it filled
If Scheduled Drugs are involved in transfers you must collect...
Pharmacies DEA on the transfer form.
Substituting Drug Formulations (p. 43)
Pharmacist CAN select a different *formulation* if: 1. Same strength 2. same duration of therapy 3. change will improve ability of pt to comply w/ tx Ex. child prescribed a med in tablet form, but unable to swallow tablets, pharmacist may choose to switch to suspension
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
Pharmacist to staff ratios (p. 20)
Pharmacist to Intern: 1 pharmacist to 2 interns Pharmacist to Technician: *Outpatient*: --1 tech for first pharmacist --2 techs for each additional pharmacist (2 pharmacists = 3 techs) (3 pharmacists = 5 techs) *institutional*/hospital --2 techs per pharmacist on duty
Who can transfer in Cali?
Pharmacists and Interns
Tech-Check-Tech Program
Pharmacists need to check Tech fills unless: 1. Tech-Check-Tech program 2. Acute care hospital with ongoing clinical pharmacy program 3. pharmacists must be located in pt care areas 4. medication orders must have been previously approved by a pharmacist Tech canNOT approve orders, ONLY can confirm the accuracy of the filling *Pharmacist must still check all:* 1. compounded or repackaged drugs
Senate Bill 493 SB493
Pharmacists=Providers
Change of PIC
Pharmacy and departing PIC reports to BOP within 30 days
promethazine
Phenergan
promethazine/dextromethorphan
Phenergan DM
promethazine/phenylephrine
Phenergan VC
promethazine/phenylephrine/codeine
Phenergan VC with codeine
promethazine/codeine
Phenergan with codeine
promethazine
Phenergan/Promethegan
calcium acetate
PhosLo/Phoslyra
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
levonorgestrel
Plan B
hydroxychloroquine
Plaquenil PO
May cause blurred vision
Plaquenil PDE 5 inhibitors INH Isotretinoin Ethambutol Scopolamine patch VFEND Amiodarone Anticholinergics Tamoxifen Ketek (PPIIESVAAT K)
clopidogrel
Plavix P2Y12 Prodrug
felodipine ER
Plendil DHP
cilostazol
Pletal Vasodilator - claudication
pneumococcal
Pneumovax
Notice to consumers
Posted in pharmacy: You get your med unless Not covered Unable to pay OOS Illegal/harmful Ethical dodge You get your script back CA law requires consult on New rx RX drug label in 12 pt font Interpreter services available on request no cost Before taking know name, how, how long, miss dose, ADE, DDI Ask if ? If OOS we will help
dabigatran
Pradaxa Direct thrombin inhibitor
repaglinide/metformin
PrandiMet Meglitinide/biguanide
repaglinide
Prandin Meglitinide
pravastatin
Pravachol Low-Mod 10-80mg
idarucizumab
Praxbind
acarbose
Precose Alpha glucosidase inhibitor
Which steroid to use for Allergic Conjunctivitis and why?
Prednisolone 1% but it increases IOP Lotemax [loteprednol] have little to no affect on IOP IOP = Intra-Occular Pressure
conjugated equine estrogens
Premarin
medroxyprogesterone/conjugated estrogens
Premphase/Prempro
Mandatory Reporting
Prepare/send written report w/in 2 working days for child abuse or 36hrs for 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
lansoprazole
Prevacid PPI
omeprazole
Prilosec PPI
ASCVD risk assesses individual risk of have a cardiovascular event like MI, stroke or death with 10 years ≥ 7.5% age 45 to 75 year old
Primary Prevention: LDL ≥ 190mg/dL ------------------------------- High Diabetes + ≥ 7.5% ASCVD --------------------- High ------------ ≥ 7.5% ASCVD ------ Moderate to High Diabetes ------------------ ------- Moderate Secondary Prevention: Use Moderate Intensity statin on patients over 75 years old
ampicillin
Principen
lisinopril
Prinivil/Zestril
desvenlafaxine
Pristiq
nifedipine ER
Procardia XL/Adalat CC/Nifedical XL/Afeditab CR DHP
epoetin alfa
Procrit/Epogen ESA
Levonorgestrel (p. 61)
Progestin ONLY EC Plan B 1-Step 1. No age restrictions 2. OTC, kept next to condoms/family planning supplies 3. can be purchased even if pharmacy section in the store is closed Plan B (2 pills) 1. Only for 17+ years old (must check ID) 2. Kept behind the counter
progesterone
Prometrium
proacainamide
Pronestyl Ia (fast Na+K)
Drug incompatible with Calcium Chloride?
Propofol Magnesium Sulfate Sodium Bicarbonate "PMS"
finasteride
Proscar [Propecia (hair)]
Pulmonary hypertension drugs?
Prostacyclin, Flolan [epoprostenol] Ventavis [iloprost] Tracleer [bosentan] Revatio Adcirca
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.
Therapeutic Interchange Protocol (p. 47)
Protocol established as a *Cost-saving strategy* to *substitute* one drug for another drug in the same class that is therapeutically similar i.e. substituting Crestor for Atorvastatin Can also include *IV:PO conversions/substitutions*
pantoprazole
Protonix PPI
Which PPI or H2RA are safe with Plavix?
Protonix [pantoprazole] All H2RA except cimetidine
albuterol
Proventil MDI/ProAir/Ventolin/AccuNeb
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
Dispensing Blood Clotting Products for Home Use (p. 55)
Providers of clotting factors 1. maintain 24-h on call service everyday of the year 2. ability to obtain all FDA approved blood clotting products (low, med, high) 3. supply all ancillary infusion equipment 4. Ship everything to pt w/in 2 business days
modafanil
Provigil
DATA 2000 (p. 91)
Provision that permits prescribing of narcotics for opioid addiction treatment
fluoxetine
Prozac/Sarafem
Pseudophedrine, Ephedrine, Phenylpropanolamine, Norpseudophedrine (p. 110)
Pseudoephedrine 1. Must be behind the counter or in a lock box 2. Max OTC purchases --*3.6 grams*/day --*9 grams* in a 30-day period --*7.5 grams* in a 30-day period (*Mail order*) --3 packages per transaction *EXCEPTION* sale of 60 mg or less of pseudoephedrine customer does NOT have to show photo identification Normally customer must: 1. show photo ID or passport Pharmacy staff must: 1. record items and quantity the pt received 2. Customers must record their: --name --address --date and time of sale 3. Store staff *MUST* verify this info by verifying photo ID matches the customer Log book must be kept for at least: *2 years* Stores must "self-certify"/self-train to the attorney general of the US that they are trained in selling of pseudoephedrine
Maintain x at least 2 yrs
Pseudoephedrine, ephedrine, phenylpropanolamine, & norpseudoephedrine sale logs
Maintain x at least 6 yrs
Pt acknowledgement of HIPAA
Maintain x at least 1 yr
Pt med profile Med error/QA reports
Patient Medication Profiles
Pt's who rill Rx's at that pharmacy must be kept on file *UNLESS* the pharmacist feels that the pt will never return Pt profiles to include: 1. Pt's Full name, address, phone #, DOB, Gender For each medication on the pt's profile: 1. Name, strength, dosage form, route of admin, quantity and directions 2. Prescriber's name, license #, DEA (if needed) 3. Date drug was dispensed or refilled 4. Rx # Pt medication record will be kept for *1 year* from the date when the last Rx was filled
budesonide
Pulmicort flexhaler DPI
dornase alfa
Pulmozyme
Notice to Consumers (p. 37)
Purpose: to let pt's know they have certain rights 1. Right to receive counseling 2. right to ask questions 3. Easy-to-read type 4. Interpreting services Must be in *Public View* Can order posters on Board's website
Repackaging (p. 48)
Put from larger container into smaller vials can be used for fast movers MUST be labeled with (at least): 1. Name of drug 2. strength 3. dosage form 4. manufacturere's name 5. lot # 6. expiration date 7. Quantity any original packaging/handling instructions must be followed when repackaging or else may conflict w/ approved labeling
phenazopyridine
Pyridium/AZO-standard (OTC) Urinary analgesic
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
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
cholestyramine resin
Questran Light/Prevalite/Questran
quinidine
Quinidex Ia (fast Na+K)
silodosin
Rapaflo
galantamine
Razadyne AChEi
naltrexone
ReVia/Relistor(methyl) Opioid antagonist Alcohol/Opioid dependence Opioid-induced constipation Make you feel like shiiiiiiit IM, subq, PO
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
ribavirin
Rebetol/Ribasphere/Copegus
Orally Transmitted Prescriptions (p. 24)
Received and reduced to writing ONLY by: 1. *Pharmacist* 2. *Pharmacist intern* "reduce to writing": write the oral Rx onto the pharmacy's prescription blank, whoever took the the Rx over the phone MUST *initial* the Rx and if dispensed by another pharmacist that pharmacist *also initials* the Rx
zolendronic acid
Reclast/Zometa IV
DEA Form 41
Record of controlled substances destroyed
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.
Waste containers
Red: Sharps (return at 2/3 full) Blue: Non-Hazardous Yellow: Trace Chemotherapy Black: Hazardous Electrolytes/Vitamins can sink
Outsourcing Facility
Register with FDA submit drug report initially and in June and December. Sterile injectable compounding cant outsource
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 Form 225
Registration form for manufacturers, distributors, researchers, importers, exporters Get DEA number
DEA 363
Registration form for narcotic treatment programs
DEA Form 363
Registration form for narcotic treatment programs
DEA 224
Registration form for retai pharmacies, hospitals/clinics, practitioners, teaching institutions, or mid-level practitioners
DEA Form 224
Registration form for retail pharmacies, hospitals, practitioners, teaching institutions, or mid-level practitioners Get DEA number
metoclopramide
Reglan Nausea/gastroparesis
nabumetone
Relafen PO - Arthritis MOA: Cox-1 and -2 inhibitor, antipyretic, anti-infl Dose: 1000mg; max 2000mg/d *Max 1000mg/d in CrCl <30 SE: GI, edema, dizziness, pruritis *NSAIDs increase risk of serious CV events
zanamvir
Relenza Inhaled Influenza A&B
mirtazapine
Remeron
infliximab
Remicade IV
Tech abilities
Remove drug from stock Filling Affix label Packaging
sevelamer
Renagel
abciximab
Reopro GP IIb/llla inhibitior
Loss/theft of controlled drugs
Report to DEA immediately (1 day) Report to CA BOP w/in 30 days
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
CURES
Report to cures weekly
DEA 106
Reporting the theft or significant loss of controlled substances
DEA Form 106
Reporting the theft or significant loss of controlled substances
Form 106:
Reporting theft or significant loss of controlled substance.
Requesting DEA forms for the first time
Request initial 222 forms w/ DEA form 224 additional DEA forms can be ordered via DEA website
ropinirole
Requip DA agonist
Controlled drugs Aux Label
Required for C II - IV (not V): "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed"
Rx Transfers (p. 27)
Required info: 1. Name of pharmacy 2. original date and last fill date 3. number of refills remaining
Technician Trainee
Required to compete externship as part of program to become technician Can perform all tech duties under RPh supervision
temazepam
Restoril
zidovudine
Retrovir NRTI
Name PDE 5 Inhibitors used in pulmonary hypertension? Phosphodiesterase 5 Inhibitors Erectile Dysfunction drugs
Revatio 20mg TID --- Viagra only 50mg before sex Adcirca 40mg Daily --- Cialis only 10mg 1hr before sex or 2.5 to 5 mg daily
nalmefene
Revex Opioid antagonist IM, subq
methotrexate
Rheumatrex PO/SC/IV
budesonide
Rhinocort Aqua Nasal spray
rifampin
Rifadin (RIF)
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
risperidone
Risperdal Prolactin SE, EPS
methocarbamol
Robaxin PO, IV(diluted/undiluted D5W/NS), IM(glutes) Muscle spasms/tetanus MOA: General CNS depression Dose: PO 1.5g 4x/day; IM/IV 1gm q8hr x3days SE: HoTN, confusion, dizziness, rash, GI
glycopyrrolate
Robinul Excessive sweating
calcitriol (Vit D3)
Rocaltrol
ceftriaxone
Rocephin 3rd gen IV/IM
morphine
Roxanol (liq)/Duramorph/Infumorph PO, IM, SubQ, IV(D5W,D10W,NS) MOA: Inhibits pain pathway at opioid receptors; generalized CNS depression Dose: 10-30mg q4h SE: CNS, C/N/V, urinary retention, edema CII
oxycodone
Roxicodone Opioid CII
ramelteon
Rozerem
Emergency Contraception
RpH can prescribe after 1 hour CE Can provide 12 condoms, may charge $10 fee not if covered by insurance
Sterile Compounding
Run fan 24/7 or 30 minutes before compouinding Certify hood q 6 mo. Keep 3 years
Deceased Prescribers
Rx's still valid (all other rules for valid rx's still apply) RPh should encourage pt to look for new MD
Nicotine Replacement therapy (p. 66)
Rx: inhaler and nasal spray Req to furnish NRT therapy: 1. *2 hours of CE or equivalent curriculum based training program in the last 2 years of pharmacy school* 2. ongoing CE on smoking cessation every 2 years 3. Reviews pts current tobacco use and quit attempts 4. Asks the pt: --Pregnant (if yes, do NOT furnish NRT) --Heart attack w/in 2 weeks? furnish w/ caution --Hx of heart palpitations? furnish w/ caution --freq chest pain? furnish w/ caution --allergic rhinitis? do not furnish nasal spray --TMJ? do NOT furnish the gum 5. Notify pt's PCP of what they received, or provide the pt a written record of what they received Records for furnishing NRT's kept for: *3 years*
Furnishing Travel Medications
SB 493 permits pharmacists to do Must meet following reqs: 1. complete approved immunization cert. program 2. complete approved travel med program --10 hours long 3. Complete CDC's Yellow Fever Vaccine Course 4. Have basic life support 5. Complete 2 hours of CE focused on travel medicine (*Separate* from CE on immunizations) every *2 years* Pharmacist must follow these steps 1. Good faith evaluation 2. travel hx must include all risk assessments during pre-travel consultation outlined in CDC's *Yellow Book* 3. notify PCP of drugs dispensed *w/in 30 days, or doc in shared system, or provide pt written record* 4. Provide pt w/ progress note which documents clinical assessment and travel medication plan - available on boards website
Maximum volume for SC and IM injections
SC - 2 mL IM - 5 mL
CI in GFR < 30
SGLT2 inhibitors Metformin
which meds are exempt from CR packaging?
SL NTG oral COC hormone replacement powdered unflavored aspirin effervescent aspirin powdered iron preparations effervescent APAP
When to stop antithrombotics before surgery?
STOP antithrombotics 5 to 7 days before surgery You can use heparin during and after surgery.
asenapine
Saphris SL only
Emergency Refills w/out Rx (p. 26)
Schedule *III - V* can be refilled w/out prescriber's authorization if prescriber is unavailable and in pharmacist's judgement the failure to refill the Rx might interrupt the patient's ongoing care and have significant effects on the pt's well-being must make every reasonable effort to contact the prescriber Must document the emergency fill must notify the prescriber w/in a reasonable amount of time CA does NOT define a specific number of days supply on an emergency fill *non-schedule drugs* - can provide up to the full fill *schedule drugs III-V* - only provide reasonable amount to cover the emergency period *NO refills for Schedule II drugs*
Single Codeine tablet
Schedule II But a combo product containing 1.8 g/ 100mL is schedule V.
Benzos and Z drugs are...
Schedule IV Belviq QSYMIA as well
Codeine (p. 83)
Schedule changes depending on formulation Schedule II: if single agent Schedule III: if in combo product Schedule V: if formulated as cough syrup
Epinephrine Pens
Senate bill 669 Can give to school nurses/trained people <66lbs=epipen jr.(0.15g) white label 2nd grade or less mgyellow label 0.3g
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.
senna
Senokot/Exlax
cinacalcet
Sensipar Osteoporosis
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
Compounding pharmacy
Seperate license renewed annually Sterile compounding license is different Can compound for office use 72h supply 120h for veterinary Records: Master formula Name/Str/Date/Compounder/Qty/QTY Used Lot/Exp/BUD 3 years Low-medium risk: Annual training High risk: Semi-annual training
sulfamethoxazole/trimethoprim
Septra (DS)/Cotrim/Bactrim (DS)
salmeterol
Serevent
quetiapine
Seroquel/Seroquel XR
reserpine
Serpasil Depletion of monoamine neurotransmitters
nefazodone
Serzone Serotonin receptor antagonist/reuptake inhibitor
BETA blocker hides which hypoglycemia symptoms?
Shakiness Anxiety Palpitation "SAP"
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)
carbidopa/levodopa
Sinemet DA agonist
doxepin
Sinequan/Silenor (insomnia)
montelukast
Singulair
metaxalone
Skelaxin skeletal muscle relaxant
metaxalone
Skelaxin/Metaxall PO - skeletal muscle relaxant MOA: General depression of nervous system Dose: 800mg 3-4x/day SE: Dizziness, drowsiness, HA, irritability, GI, rash
VESIcare
Solifenacin
carisoprodol
Soma PO - Skeletal muscle relaxant MOA: Not clear - central depressant actions Dose: 250-350mg TID and qHS for max of 2-3wks *Long-term use requires a slow taper SE: Drowsiness, dizziness, HA
zaleplon
Sonata
Centralized Hospital Packaging
Specialty license for a hospital pharmacy to perform centralized packaging for the hospital and one or more general acute care hospitals under common ownership located within 75 miles of each other
tiotropium
Spiriva
Herbal products that decrease warfarin effect?
St.John's Q10 ginseng green tea is full of Vitamin K
carbidopa/levodopa/entacapone
Stalevo DA agonist
nateglinide
Starlix Meglitinide
State Laws v.s. Federal Laws (p. 83)
State laws may ONLY be *MORE strict* than federal laws canNOT be weaker
Transaction history
Statement including transaction info for each prior transaction going back to manufacturer of the product
trifluoperazine
Stelazine 1st gen antipsycotic High potency
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 #
prednisone
Sterapred Nasal Spray
atomoxetine
Strattera
CI in CrCl < 50
Stribild Vfend
PIC Liability
Strict liability for violation of law in pharmacy with or without knowledge of violation
Max injectable volumes
SubQ: 2 mL IM: 5 mL
nisoldipine ER
Sular DHP
tetracycline
Sumycin
Cancelling or Voiding DEA Form 222 (p. 88)
Supplier can void the whole or part of the CII order if voided: supplier draws lines through cancelled items on copies 1 and 2 and prints the word *VOID* Purchaser can cancel all or part of an order on a form 222 1. notify supplier in writing 2. supplier draws a line through cancelled CII's on form 222 and writes "*Cancelled*" next to the cancelled drugs
cefixime
Suprax 3rd gen PO
budesonide/formoterol
Symbicort MDI
amantadine
Symmetrel Anticholinergic
optomietrist license ends with?
T
T/F There is no need of a contract outlining the refill arrangement between the central fill and refill pharmacies, if these pharmacies are owned by the same owner.
TRUE.
calcium carbonate
TUMS
Compounding by California Law standards *does not include*
Tablet Splitting Tablet Crushing Capsule opening Adding flavoring agents.
Non-PVC containers
Tacrolimus Insulin NTG Ativan Amiodarone
cimetidine
Tagemet H2RA
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.
pentazocine
Talwin Opioid partial agonist CIV-federal IM, IV, PO
oseltamivir
Tamiflu PO Influenza A&B, avian flu Renal dose adjustments
albiglutide
Tanzeum GLP-1 agonist
methimazole
Tapazole
5th gen cephs
Teflaro
ceftaroline
Teflaro MRSA-fied 3rd gen IV
carbamazepine (CBZ)
Tegretol/Tegretol XR/Equetro 1st-line for partial seizures; ok for generalized tonic-clonic
aliskiren
Tekturna Direct renin inhibitor
Counterfeit drugs
Tell board w/in 72 hours
atenolol/chlorthalidone
Tenoretic
atenolol
Tenormin
terconazole
Terazol
benzonatate
Tessalon
Drugs with REMS
Thalidomide Isotretinoin Clozapine Qsymia Long Acting Opiates (MS Contin, Oxycontin, etc) Saxenda Forteo
chlorthalidone
Thalidone Thiazide
Is there an AntiDote for Reopro?
The AntiDote for Reopro [abciximab] is platelet infusion.
Practitioners may prescribe medication under the DEA registration of: (p. 91 bottom)
The hospital or institution they are working at include the physician's hospital code number at the end (p. 91 bottom)
Your license expires...
The last day of the month of your birth.
When does a pharmacist's license expire?
The last day of the pharmacist's birth month
theophylline
TheoDur/Theo 24
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.
Which diuretic is for HTN and which is for CHF?
Thiazide is for HTN LOOP and K-sparing diuretic is for CHF
chlorpromazine
Thorazine 1st gen antipsychotic Low potency
GLP-1 Agonist [Black Box Warning]
Thyroid Tumor Weight loss
liotrix
Thyrolar
ticlopidine
Ticlid P2Y12 Prodrug
trimethobenzamide
Tigan For N/V
What is Tigan and its indication?
Tigan [trimethobenzamide] - block CTZ vomiting Use Tigan to prevent Apokyn induced emesis.
timolol
Timoptic Beta-blocker for glaucoma
Report left/theft of CS drugs by
To DEA immediately (1 business day) To BOP w/in 30 days
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
tobramycin/dexamethasone
Tobradex
imipramine
Tofranil
topiramate
Topamax Ok for partial, atypical absence, myoclonic, atonic, and generalized tonic-clonic seizures. CI if sulfa allergy
How long can you use Toradol and why?
Toradol is brand for ketorolac - Maximum of 5 days treatment because of GI bleed - 20mg once after IV/IM therapy then 10mg Q4-6HR [MAX 40mg/day]
linagliptin
Tradjenta DPP4i
What is the risk with Ultram?
Tramadol increases risk for SEIZURE and Serotonin syndrome
labetalol
Trandate/Normodyne
scopolamine
Transderm Scop
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.
chlorazepate
Tranxene
travaprost 0.004%
Travatan/Travatan Z PG analog
pentoxyfylline
Trental
fenofibrate
Tricor/Antara/Lofibra/TriLipix/Triglide Rhabdomyolysis and myopathy
perphenazine
Trilafon 1st gen antipsycotic Medium potency
oxcarbazepine
Trileptal 1st-line partial seizures; ok for generalized tonic-clonic
ethinyl estradiol/levonorgestrel
Trivora/Levora/Aviane
zidovudine/lamivudine/abacavir
Trizivir NRTI, NRTI, NRTI
Though it's untouched, if it was ever handed to patient or member of the public, it can never be accepted as a donated drug.
True. donated drug must be either received directly from the manufacturer/wholesaler or were returned from a health facility to which the drugs were originally issued.
dulaglutide
Trulicity GLP-1 agonist
dorzolamide
Trusopt CA inhibitor
emtricitabine, tenofovir
Truvada NRTI, NRTI
hydrocodone/chlorpheniramine
Tussionex Antihistamine/analgesic
tigecycline
Tygacil
codeine/acetaminophen
Tylenol #2/#3/#4/Tylenol with codeine PO(tab,soln/susp-120mg) MOA: Dose: 300-1000/15-60mg q4h; max 4000/360mg in 24h *Taper off to d/c SE: CNS, drowsiness, pruritus, constipation, N/V CIII-tab, CIV-soln/susp *Caution with 2D6 ultra-metabolizers
febuxostat
Uloric
tramadol/acetaminophen
Ultracet CIV
tramadol
Ultram/Ultram ER CIV
ampicillin/sulbactam
Unasyn
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
moexepril
Univasc
What percentage of compounded meds can be shipped out of state
Up to 5% only.
Within 30 days of giving a vaccine a pharmacist must
Update the patient's provider or any state/national immunization data bases.
What are the Ups and Downs of Loop Diuretic?
Ups: TriGlycerides, Cholesterol, Photosensitivity, Glucose, Uric acid[bad for Gout people], HCO3 [bicarb] Downs: Na, Mg, Cl, Ca
Class II Recall
Use/exposure can cause temp or reversible ADR or where probability of harm is remote - Particles in vials
Class III Recall
Use/exposure not likely to cause ADR - Coloring off
voriconazole
VFEND
estradiol
Vagifem/Climara/Vivelle DOT
CIII-V refills
Valid 6 mo. or 5 refills. 120 days in 1 refill (V(No 120d refill restriction or # refills) CIII-V can be filed with non-control if they have a 1 inch letter C on them
Rx's from dead prescribers (p. 23)
Valid Rx written while the prescriber was alive *ARE* valid 1. No more than 6 months from the *date written* for controlled substances 2. no more than *1 year* from the date written for non-controls (*standard of practice*/not a law) If pt starts to see a new prescriber, the pharmacist should *request* a new Rx from the new prescriber
diazepam
Valium
valacyclovir
Valtrex zoster, simplex, varicella
vancomycin
Vancocin
Freezer drugs
Varicella(Varivax) MMRV(ProQuad) Zoster(Zostavax) Cholera(Vaxchora)
varicella
Varivax
icosapent ethyl (fish oil)
Vascepa
enalapril
Vasotec
penicillin
Veetids (Pen-VK)
verapamil
Verelan/Calan/Covera-HS/Isoptin Non-DHP
midazolam
Versed
solifenacin
Vesicare Over-active bladder
sildenafil
Viagra [Revatio (PAH)]
doxycycline
Vibramycin
hydrocodone/ibuprofen
Vicoprofen/Xylon/Ibudone PO MOA: Inhibits pain pathway at opioid receptors/Cox-1 and -2 inhibition Dose: 2.5-10/200mg q4-6hr; max 12.5-50/1000mg *Short-term use is rec SE: Resp failure, CNS, pruritus, N/V, edema *Taper off *NSAIDs increase risk of serious CV events CII
liraglutide
Victoza/Saxenda GLP-1 agonist Saxenda=weight loss
boceprevir
Victrelis HCV
moxifloxacin
Vigamox
Refrigerated eyedrops
Viroptic Zioptan Xalatan
Security Prescription requirements
Void under photocopy California Security Prescription Watermark Chemical void Opaque writing Check box for Qty and refills CII on regular pad if pt terminally ill handwritten 11159.2 exemption (can fill w/out but MD must send correction in 72h)
diclofenac
Voltaren DR/Voltaren ER PO (DR, ER, IR, powder), PR, IV(bolus) MOA: COX-1 and -2 inhibitor Dose: 50mg TID, 100mg daily, 37.5mg IV q6hr *Use not rec in severe renal disease SE: Edema, HTN, HA, rash, GI *NSAIDs increase risk of serious CV events Stor/Stab: IV-protect from light
diclofenac
Voltaren Ophthalmic
Pharmacy Recovery Program
Voluntary basis May be referred to in lieu of or in addition to discipline by board
ezetimibe/simvastatin
Vytorin
CI medications (p. 83 bottom)
Weed heroin LSD Mescaline Peyote MDMA GHB sodium salt (Sodium oxybate is CIII)
How often to complete? Submitting dispensing data to CURES
Weekly
Submitting dispensing data to CURES
Weekly
Submit dispensing data to CURES
Weekly, even if number is 0
colesevelam
Welchol 6 tabs/day Less GI than others in the class
bupropion
Wellbutrin SR
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.
days
When board inspector issue order of abatement, pharmacy may appeal to the Board within 30 days. When requested by Board, pharmacy must retrieve records within 3 days (extensible to 14 days) When patient request, they may able to retrieve their record in 5 days, receive the copy within 15 days. Once immunized, pharmacy report to CAIR within 14 days of admin if a pharmacist suspects another pharmacist is impaired at work, they must report this to the board within 14 days. Report significant loss of CS theives : 1 day to DEA, 30 day to board
Who can restock ADD ? when restock is being done at the facility, when removable drawer of the cart is brought to the pharmacy,
Who can restock ADD ? when restock is being done at the facility, pharmacist can restock when removable drawer of the cart is brought to the pharmacy, intern, rph and tech can restock
Reporting Time Period? Theft by or impairment of a license
Within 14 days
Begin med error investigation
Within 2 days of error
How often to complete? Medication error investigation
Within 2 days of error
N.D Naturopathic Doctor
Works under protocol, can't do C2
CA Security Form in Terminally Ill
Write "11159.2 exemption" on plain rx Only for terminally ill: Death expected w/in 1yr
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.
latanaprost 0.005%
Xalatan PG analog
alprazolam
Xanax
oxycodone ER/acetaminophen
Xartemis XR Opioid - long-acting CII
levalbuterol
Xopenex MDI/Xopenex Neb
lidocaine
Xylocaine Ib (fast Na)
sodium oxybate
Xyrem CIII
levoceterizine
Xyzal
Can drug be delivered when pharmacy is closed where no pharmacist is present in the building?
YES. refer p110.
A non-licensed person (clerk/typist) is permitted to type a prescription label or otherwise enter prescription information into a computer record system, and at the direction of a pharmacist, may request and receive refill authorization.
YET! clerks cannot touch the drug bottles unless at the cashier, where the clerk hands out the drug to the patient.
ethinyl estradiol/drospirenone
Yasmin/Yaz
Do patients have a right to obtain a copy of their records?
Yes - May inspect them within 5 business days - Must obtain copies within 15 business days
Can Pharmacist switch formulations? (ex: tab to solution)
Yes - Must have same active ingredients of equivalent strength and duration of supply - If the change will improve adherence *not permitted between long acting and short acting forms or combo products
Can pharmacy furnish #compounded products to prescriber for office use or for distribution? If so, how much of amount?
Yes, 72 hour supply.
Prescription on CII was received on a non-california security form for a terminally ill patient. Pharmacist is aware of the patient and terminal status of the patient, but prescriber did not indicate "11159.2 exemption" on the prescription. Can you still fill it?
Yes, RPh may fill as long as prescriber returns corrections on it within 72 hours.
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 Pharm.D convert a 30 day prescription to 90 day?
Yes, if: - Non-controlled, non-psychotic drug - Pt has completed an initial 30-day supply with no side effects - Pt previously received 90 day supply - Total quantity dispensed does not exceed amt authorized on the prescription - Pharmacist notifies prescriber
What is the requirement to be registered as an outsourcing facility under 503B? (hint: very simple) can a pharmacy operate as an "outsourcing facility"?
Yes, pharmacy can be an outsourching facility. The facility needs to be compounding sterile drugs for human.
Can a prescriber write a prescription for controlled and non-controlled drugs on the same Security Rx
Yes, you can have BOTH on the same Rx
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 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.
When you receive a 222 ordr
You fill out the right side of copy 3. and keep it for 3 years.
tizanidine
Zanaflex PO(Cap-can sprinkle on food) MOA: Alpha2-adrenergic agonist Dose: Initial 2mg TID; max 36mg; gradual taper off *CrCl<25-use with caution SE: HoTN, drowsiness, xerostomia, weakness; Monitor live function
ranitidine
Zantac H2RA
metolazone
Zaroxolyn Thiazide-like diuretic
bisoprolol
Zebeta
Schedule II drugs can be transferred...
Zero times.
lisinopril/HCTZ
Zestoretic/Prinzide
ezetimibe
Zetia
bisoprolol/HCTZ
Ziac
azithromycin
Zithromax/Z-pak/Tri-Pak/AzaSite/Zmax
simvastatin
Zocor Low-Mod 5-40mg
ondansetron
Zofran/Zofran ODT 5HT3 antagonist (N/V)
sertraline
Zoloft
zolmitriptan
Zomig Serotonin receptor antagonist
Herpes Zoster
Zostavax
piperacillin/tazobactam
Zosyn
acyclovir
Zovirax zoster, simplex, varicella
bupropion
Zyban
zileuton
Zyflo CR Leukotriene inhibitor
allopurinol
Zyloprim/Aloprim (IV)
olanzapine
Zyprexa/Zyprexa Zydis (ODT) High risk for weight gain/metabolic SE
cetirizine
Zyrtec
cetirizine/pseudoephedrine
Zyrtec-D 12H +decongestant
linezolid
Zyvox
a pharmacist can dispense ephienphrine auto injectors to?
a first responder or lay rescuer who is trained and qualified school district or charter school
UFH Regular Heparin Monitor
aPTT or anti-Xa Hgb, Hct, PLATELET Regular Heparin doesn't need Renal adjustment You have HIT if platelet drops > 50% from baseline
clerks can?
accept prescriptions at the drop off window verify patient's insurance coverage type prescriptions ring up pateints at the prescription pick-up window put drugs on the shelves
a pharmacist can select another drug with the same
active chemical lingredients strengths quanityt dosage form generic
SB 493 ALLOWS ALL licensed pharmacists to:
admin drugs and biologics provide drug and disease info participate in reviews of pt progress furnish: COC, travel meds, nicotine replacement products initiate and administer routine immunizations to patients >3 y/o order and interpret tests
two pill levonorgestrel: behind the counter:
age: atleast 17 years old no gender restriction
Tekturna
aliskiren + HCTZ
Caverject
alprostadil - Penis injection - Drug goes in the fridge
Cordarone
amiodarone Monitor: thyroid, liver, lung - broad-spectrum anti-arrythmic - safe in heart failure and post MI - ACLS life threatening arrhythmia
Non-PVC Containers
amiodarone nitroglycerin insulin lorazepam tacrolimus
Lotrel
amlodipine + benazepril
Azor
amlodipine + olmesartan
Exforge
amlodipine + valsartan
NS only compatibility
ampicillin Unasyn Invanz (ertapenem) Cubicin (daptomycin) Cancidas (caspofungin) phenytoin Remicade (infliximab)
state of CA: pharmacists can dispense up to how much of a supply of self-admin hormonal contraceptives?
annual
LMWH Monitor Innohep [tinzaparin] Fragmin [dalteparin] Lovenox [enoxaparin]
anti-Factor Xa levels Low Molecular Weigh Heparin like Lovenox doesn't use aPTT Hgb, Hct and PLATELET SCr
adulterated?
any drugs, whether recognized in official compendia or not, its strength quality or purity lower than listed on the label/offcial standards. Then the drug is adulterating the product.
What is Apokyn use for and what is its contraindication?
apomorphine Do NOT use with 5HT3 antagonist like Zofran due to severe hypotension
Treatment for Heparin Induced Thrombocytopenia?
argatroban or Acova
how many times can non-controlled drugs be transferred
as many times as there are refills remaning
recipients of Aid in dying drugs must be?
atleast 18 california resident mentally competent diagnosed with a terminal illness that will lead to death within 6 months
pharmacists can independently initiate and administer ROUTINE immunizations to patients what age?
atleast 3 years old
medicare is federal health insurance for?
atleast 65 years old less than 65 years old with disability ESRD
a prescription for a controlled substance for a legitimate medical purpose can only be issued by a practitioner who is?
authorized to prescribe controlled substances by the state registered with DEA or exempt from DEA registration an employee of a DEA-registered hospital or institution
Manufacturer, distributor, researcher, lab, and *narcotic treatment group*
begin with P or R
when self-assessment forms are completed
biennially before July 1 of each odd numbered year
pharmacists can furnish which types of medications without prescriber
birth control naloxone travel medications nicotine replacement products immunizations for age > and = to 3 years
what fact sheets do you give with self-administered hormonal contraceptives?
birth control guide such as the one from the FDA patient product information administration fact sheet for the formulation
xulane
birth control patch
Azopt
brinzolamide Indication: glaucoma Carbonic anhydrase inhibitor Shake suspension
Stadol
butorphanol Schedule IV - pain in labor/anesthesia/nasal spray for migraines
Automated Drug Delivery Systems (ADDS)
cabinets used to store and dispense drugs in 1. Hospitals 2. Skilled nursing facilities (SNF) 3. Intermediate Care facilities (ICF) Risk of diversion in SNF and ICF are higher than at hospitals If the cabinet is used to house and dispense *scheduled drugs* a DEA registered pharmacy must manage the cabinet (p. 47 bottom) *Requirements for SNF and ICF* 1. Policies and procedures to ensure proper dispensing and storage of meds 2. pharmacist reviews each med order + pt's profile before the drug is removed from the ADDS 3. Override functions are ONLY used in emergencies 4. When cabinet is stocked directly in the facility, MUST be done by a pharmacist 5. If containers are to be filled offsite, they can only be restocked (put back into the machine by a pharmacist, intern pharmacist or pharmacy technician) (p. 48)
who can be the power of attorney for DEA forms 222 and CSOS
can be anyone, just has to be someone the person trusts
class i recall
can cause death
benefits of outsourcing facilities?
can compound drugs in bulk without prescriptions for specific patients can distribute across state lines exempt from the new drug approval process exempt from labeling with adequate directions for use
out-of-state prescription
can fill if license if equivalent to that required of a CA prescriber
PIC
can supervise up to 2 pharmacies as long as they are within 50 driving miles of eachother any change of PIC - must be reported within 30 days must complete biennial pharmacy self-assessment form before july 1 of each odd numbered year
Pharmacy Going Out of Business (p. 106 bottom)
can transfer *ALL* medications (including schedule II) to the new pharmacy ownder Inventory records are taken and used in the sale of the inventory to the new owner Inventory records are *NOT* sent to the DEA Pharmacy can also transfer controlled substances to the original supplier, manufacturer or distributor for *disposal*
emergency refill limit: schedule II
cannot be dispensed without the prescriber's authorization
out of country prescriptions
cannot fill
Ceclor
cefaclor [ 2nd generation ]
Duricef
cefadrozil [ 1st generation ]
Cefzil
cefprozil [ 2nd generation ]
Fortaz
ceftazidime cover pseudomonas 3rd generation cephalosporin
Ceftin
cefuroxime [ 2nd generation ]
Zinacef
cefuroxime [ 2rd generation ]
Zyrtec
cetirizine [OTC, RX]
Chlor-Trimeton
chlorpheniramine
Do NOT refrigerate
cipro, levo, moxifloxacin azithromycin, clarithromycin clindamycin doxycycline Bactrim cefdinir metronidazole enoxaparin IV: Septra Avelox Flagyl Zovirax furosemide phenytoin Precedex (dexmedetomidine) Ofirmev Nexium Neosynephrine (phenylephrine)
Tavist
clemastine [OTC]
pharmacists furnishing naloxone must follow these steps
complete 1 hr of CE ask if the recipient uses opioids or knows someone who does ask if the recipient has a known naloxone hypersensitivity provide the recipient with training in opioid overdose prevention, recognition, response, and on naloxone administration PT COUNSELING CANNOT BE WAIVED provide the board approved fact sheet with the patient's permission, the pharmacist must notify the patient's PCP that naloxone was furnished keep records for 3 years
to be able to immunize, the pharmacist must:
complete an approved immunization training program maintain BLS certification complete 1 hour of related CE every 2 years
Recall on compount
contact pharmacy, prescriber, pt, and board w/in 12 hours report to medwatch w/in 72h
prescriptions by deceased prescriber valid for
controlled substances: 6 months from the date written non-controls: 1 year from date written
When dispensing naloxone furnished by the pharmacy, ____ cannot be waived
counseling
the originating pharmacy is responsible for?
counseling maintaining medication profiles performing drug utilization reviews
Farxiga
dapagliflozin
Aranesp
darbepoetin
for schedule ii-v drugs: california pharmacies can fill and ___ ?
deliver the prescription back to the originating state
Delivering drugs to a hospital pharmacy
deliveries to a hospital pharmacy may be made to a central receiving location with one working day following the delivery, and the pharmacist on duty at that time must immediately inventory the drugs or devices.
Rph, PharmD
dependent authority -all non-controlled, CII-V drugs
Dexedrine C2
dextroamphetamine CII C2
Arthrotec
diclofenac + misoprostol
Teratogenic drugs
dihydroergotamine lithium propylthiouracil methimazole topiramate "Don't Let Pregnant Moms Take Statin"
counseling must include?
directions for use storage compliance precautions and relevant warnings
Norpace
disopyramide
for schedule III-V drugs: california pharmacies can fill and?
dispense directly to the patient
Out of *country* presciptions
do NOT fill from out of county Can fill from *US territories:* 1. Puerto Rico 2. Virgin Islands 3. Guam 4. American Samoa
pharmacist breaks
doesn't need to close pharmacy ancillary staff can perform non-discretionary tasks ONLY REFILLS THAT DO NOT REQUIRE COUNSELING CAN BE DISPENSED TO PATIENTS
Tikosyn
dofetilide Class - 3
Trusopt
dorzolamide Indication: glaucoma Carbonic anhydrase inhibitor
Cosopt "co" for combined
dorzolamide + timolol
Cardura
doxazosin
Unisom
doxylamine [OTC]
Protect from Light during Administration
doyxycline epoprostenol Nitropress (nitroprusside) Mycamine (micafungin) dacarbazine Anthracyclines pentamidine phytonadione
Marinol C3
dronabinol C3 CIII
candidates for MUE
drug is especially toxic drug causes serious ADRs drug is used in high-risk patients drug is being evaluated for addition or removal from the formulary drug is high cost
Three things pharmacist can never change on the prescription (EVEN physician says you can.)
drug itself (except generic substitution patient name prescriber's signature
pharmacist may dispense and refill an rx in a pt med pak if.
drugs are non-liquid, oral products the med pak is reused only for the same pt no more than ONE MONTH supply is dispensed at one time
for community and hospital pharmacies, drugs can get delivered if the pharmacy is closed if the following requirements are met
drugs are placed in a secure storage facility in the same building as the pharmacy only the PIC/pharmacist has access to the secure storage facility storage facility has a means of indicating whether it has been entered after the drugs were delivered the delivery person must leave docs indicating the name and amount of each drug delivered the pharmacy is resonsible for keeping delivery/storage records
what's happening on july 1st , 2019?
due self-assessment by PIC
Avodart
dutasteride
Jalyn
dutasteride + tamsulosin
Pharmacies can take back used syringes only if ?
enclosed in a sharp container
pharmacist is responsible for
ensuring safe and accurate dispensing of prescription DUE Counseling superfvising staff performing other patient care activities
naturopath can do what?
epinephrine to treat anaphylaxis natural and synthetic hormones vitamines, minerals, AA, gluta, botanicals, and their extracts, homeopathic medicines, electrolytes, sugars, and diluents
Brevibloc
esmolol
for opened containers of schedule III, IV, and V controlled substances: if dosage unit is <1000, what count is required
estimated count
DEA controlled substances inventory is performed?
every 2 years
PPIs for estrogen containing drugs must be given to patients:
every time the drug is dispensed before admin the first dose, then every 30 days in institutionalized setting
Med Guide must be given:
every time the drug is dispensed first time drug is being dispensed to a healthcare provider for admin when the pt or patient's caregiver requests it if the med guide has been revised if the drug is subject to a REMS
for sealed, unopened containers of all controlled substances, what amount is required?
exact
for opened containers of controlled substances: what count is required for schedule I and II
exact count
for opened containers of schedule III, IV, and V controlled substances: if dosage unit is >1000, what count is required
exact count
prescription refills: schedule ii:
expiration: 6 months from issue date refill limit: 0 refills
prescription refills: schedule IV
expiration: 6 months from issue date refill limit: 5 refills or 120 day supply
prescription refills: schedule III
expiration: 6 months from issue date refill limit: 5 refills or 120 days supply
prescription refills: schedule V
expiration: 6 months from issue date refill limit: N/a
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.
med guides are?
fda approved patient handounts that come with many rx medicines that have a serious and significant public health concern
Sublimaze, Oralet, Actiq, Innovar, Duragesic C2
fentanyl
drugs are considered adulterated if:
filthy, putrid, or decomposed has been prepared, packed, or stored under unsanitary conditions contains a drug recognized in official compendia, but its trength is diff from official standards, or the purity/aquality is lower drug not recognized in the official compendia, but its strength is diff from that listed on the label, or the quality or purity is lower than that on the label
Tambocor
flecanide Class - 1C
DEA controlled substances inventory record is kept?
for 3 years
dependent authorities
for non-controlled and CII-V -PharmD -CNM -NP -PA for non-controlled and CIII-V: ND
how to order schedule ii drugs
form 222 controlled substance ordering system (CSOS)
Can the oder be endoersed to another supplier when ordered with form 222. vs. electronic csos?
form 222: yes electronic csos: no (유일한 단점)
transaction history (TH)
has all the information that traces the drug from place to place, beginning when the drug leaves the MFG
how can a pharmacist substitute drug formulations?
has to be the same active ingredient of equivalent strength and duration of therapy as the prescribed drug.
tech check tech program only in (hospital/community) setting
hospital only with clinical pharmacy program ; pharmacists located in the patient care areas
Tussionex C2
hydrocodone + chlorpheniramine [H1 antagonist] CII C2
Palladone C2
hydromorphone
Motrin OTC and RX doses
ibuprofen - OTC: 200-400mg Q6-8Hr - RX: 600-800mg TID [MAX 3200mg/day] - Child: 10mg/kg/dose [MAX 40mg/kg/day]
Corvert
ibutilide Class - 3 IV only
two pill levonorgestrel: prescription
if she is 17 years old, female
when are emergency refills allowed?
if the prescriber is unavailable the patient's well-being will suffer if med therapy is interrupted the pharmacist has tried to contact the prescriber emergency refill must be documented. and the prescriber must be notified within a reasonable amount of time
Pre/Post dating prescriptions...
illegal .
Bankruptcy, insolvency, receivership
immediately
Reporting Time Period? Bankruptcy, insolvency
immediately
Indication for Indocin
indomethacin [NSAID] - Approved for gout - High risk for CNS side effects so avoid in PSYCH patients - GI bleed
Measuring BP (p. 71)
initial visit: take 2 readings, 1-2 minutes apart and record the average *Orthostatic HYPOtension* 1. record sitting BP 2. measure standing BP 1-2 minutes after sitting 3. *if BP decreased SBP: 20 or DBP: 10 mmHg = Orthostatic HYPOtension*
what can APPs do
initiate, adjust, D/C drug therapy in accordance to protocols
schedule 2 prescriptions are not valid if the following info is missing or incorrect and cannot be amended by the pharmacist:
issue date prescriber's name prescriber's signature patient's name name of the drug to be dispensed
schedule iii, iv, and v controlled substances can be partially filled if:
it is recorded in the same manner as a refill the total quantity dispensed in all partial fills does not exceed the total quantity prescribed no dispensing occurs beyond 6 months from the written date
Sporanox
itraconazole - onychomycosis nail fungus
Corlanor
ivabradine work on funny current to decrease HF monotherapy or add on if CI with BB
intern pharmacists cannot have the ____ to the pharmacy
key
drugs are misbranded if:
lack of required information false or misleading product info (false cures) lack of special precautions needed to prevent decomp illegible no brand/generic name ingredients differ from the standard of strength, quality, or purity doesn't contain the MFG and business location if there is improper packaging deficiency in packaging
Patients disposing drugs through:
law enforcement sponsored take back events collection receptacles mail back packages
a pharmacy can sell controlled substances to other pharmacies or prescribers if the total number of dosage units is?
less than 5% of the total number of controlled substances dosage units dispensed per calendar year
pseudoephedrine: max in a single transaction?
less than 60 mg (PSE) without needing to log the sale r show ID
LAAM C2
levoalphacetylmethadol "metadol like methadone" CII C2
Xyzal
levocetirizine [RX] - No CYP interaction
Dromoran C2
levorphanol CII C2
faxed rx for schedule ii drugs are not permitted, except when the rx is written for a resident at any of the following
licensed SNF intermediate care facility home health agency hospice
naturopathic doctors prescribing authority
limited to: -epinephrine to tx anaphylaxis -hormones -dietary supp -must have NDF in license # dependent auth for non-controlled, CIII-V drugs
Zestoretic
lisinopril + HCTZ
Adlyxin
lixisenatide GLP-1 Agonist Adlyxin [lixisenatide]
Drugs requiring Filter
lorazepam amiodarone -continuous infusion phenytoin Simponi (golimumab) Ambisome (amphotericin B liposomal) Lipids - 1.2 micron TPN
fluorometholone equivalents
loteprednol [Lotemax, fluorometholone 0.1% [Flarex, FML Forte] prednisolone acetate 0.12% to 1%
each provider of blood clotting products for home use must?
maintain 24 hr on call service 7 days a week for every day of the year have the ability to obtain all FDA approved blood clotting products in multiple assay ranges and vial sizes supply all necessary infusion equipment and supplies with each rx if needed ship the prescribed blood clotting products, equipment, and supplies to the patient within 2 business days
*C-I medications* (p. 86)
may be used for research w/ permission from the DEA and FDA but are NOT ordered by pharmacies nor prescribed by healthcare providers
Dolophine
methadone - Black Box Warning: QT prolongation - half-life variable
Relistor
methylnaltrexone for opioid induced constipation SC every other day
Mexitil
mexiletine Class 1B
Savella
milnacipran is used for fibromyalgia SNRI Cymbalta [duloxetine] also use for fibromyalgia
deliveries to a hospital pharmacy can be made to a central receiving location within the hospital
must be delivered to hte pharmacy premise within one working day following the delivery a pharmacist must immediately make sure that the drugs in containers match to what has been ordered
eligibility and requirements of outsourcing facilities
must be engaged in the compounding of sterile drugs for humans comply with CGMP requirements inspected by the FDA
how to become APP
must fulfill 2/3: 1. certification in relevant area of practice 2. complete residency 3. provided clinical services to patients for 1 years under a CPA or protocol
Nubain
nalbuphine Not a controlled drug
Revex
nalmefene opioid antagonist
name tag requirements?
name license status 18 point type
label for repackaged drugs;
name dosage strength manufacture name LOT number exp. date & Quantity per repackaged unit
4 items that must comprise at least 50% of the label
name of the patient name of drug and strength directions for use purpose (if indicated on prescription) (12-pt sans serif typeface) (must be clearly separated)
Label for drugs in ADDS
name strength dosage manufacturer name LOT number exp. date
what is required on a Rx
name, address of patient drug name and quantity directions for use date of issue prescriber name, address, phone # license classification DEA # if controlled purpose of drug *if req by pt prescriber's signature
Aleve dosing
naproxen OTC: 220mg BID RX: 250-550mg BID
one pill levonorgestrel: prescription: age and gender restriction
no age restriction female only
differences between DEA form 222 and CSOS
no limits of items per order CSOS can order schedule ii-v and non scheduled digital signature the order cannot be endorsed to another supplier the supplier must notify within 2 business days of filling the order (CSOS) vs end of the month
how do pharmacies report significant losses and thefts of controlled substances?
notify DEA immediately (within 1 day) notify board within 30 days submit form 106 to both DEA and board
Returning drugs to the manufacturer (p. 120)
now the pharmacy acts as the "supplier" Wholesaler (in this case) keeps copy #3 wholesaler sends copies #1  to the pharmacy Pharmacy keeps copy #1 and sends #2 to DEA
Pantanase vs Pantaday
olopatadine - antihistamine - one is nasal - one is ophthalmic
Zegerid [OTC]
omeprazole + sodium bicarbonate
how many times can schedule III- V drugs be transferred?
once
schedule iii-v are allowed how many transfers? exception?
one when pharmacist share a real time, online database with shared rx information
for both community and hospital pharmacies, drug delivery is
only delivered to the licensed premises signed for and received by a pharmacist
Who have access to a security store facility where delivered drugs are being stored
only the PIC or PIC-desingated-pharmacist
Claravis
oral isotretinoin
dea form 222
ordering, distributing, transferring schedule i and ii drugs
Daypro
oxaprozin [NSAID] - high GI bleeding like piroxicam
Ditropan
oxybutynin
Oxytrol TD
oxybutynin
How do you take Opana?
oxymorphone is taken with empty stomach
LEft off
p. 125
emergency refill limit: non scheduled
partial or full refill, at the pharmacist's discretion
Talwin
pentazocine Schedule IV - pain
Nembutal C2
pentobarbital CII C2
a pharmacist can furnish needles and syringes to patients without a prescription in the following situations
pharmacist knows the patient and the patient has a legitimate medical need. to a person at least 18 years old as a public health measure. (no limit) for use on animals, if the patient's owner is known to the pharmacist or the person's identity can be established for industrial use
form 222 required when?
pharmacy orders schedule ii from a wholesaler wholesaler sends schedule ii drugs to the pharmacy pharmacy sends unused schedule ii drugs back to a supplier pharmacy is sending unused schedule ii drugs to a reverse distributor pharmacy sells schedule ii drugs to another pharmacy pharmacy provides schedule ii drugs to a physician for administration or dispensing to a patient
Elidel
pimecrolimus for eczema
Feldene
piroxicam - high risk for GI bleeding and SJS - add PPI or misoprostol for GI protection
Minipress
prazosin
security features of written rx for medical output drugs?
prevents unauthorized copying prevents erasing/modificaiton prevents counterfeit prescription
emergency refill for CII
prohibited at least an emergency verbal order
Rythmol
propafenone
who keeps each copy of the DEA form 222? if pharmacy is purchasing?
purchaser issues form 222, keeps copy 3 pharmacy sends 1 and 2 to wholesaler then wholesaler sends copy 2 to the DEA
Lost or Stolen Form 222 (p. 88)
purchaser must re-order w/ a new Form 222 New form 222 must include: 1. serial # of lost/stolen form 222 2. date of loss 3. Statement that drugs were NOT received Send a copy of this to the *supplier* along with copies 1 and 2 of the second order form Purchaser files copy #3 of the new *and* original lost or stolen form 222 *together*
what happens when a form 222 is lost or stolen ?
purchaser writes a statement of serial number, note that it wasn't received, and date must keep this together with original copy 3 and new form. purchaser must also send 1 and 2
Novoseven
rFVIIa Arixtra [fondaparinux] antidote
Ranexa
ranolaxine Add on to decrease number of angina attacks
emergency refills for CIII-V
reasonable amount to cover emergency period until the prescriber can be contacted for a refill authorization pharmacist must not on reverse side of Rx, date and quantity of the refill and document prescriber was not available and why refilled without authorization
emergency refill limit: schedule III-V
reasonable amount to cover the emergency period until prescriber can be contacted
3. Furnish travel medications
recommended by CDC and that *do NOT require a diagnosis*
dea form 41
record of controlled substances destroyed
DEA form 363
registration for narcotic treatment programs
Morphine has a metabolite that is....
renally cleared and contributes to analgesia and sedation.
Theft by or impairment of a licensee
report w/in 14 days
Change in pharmacy permit
report w/in 30 days
Change of PIC
report w/in 30 days
Change of pharmacist address or name
report w/in 30 days
dea form 106
reporting the theft or significant loss of controlled substances
if the ADDS is restocked directly IN the facility
restocking is done by a pharmacist
DEA form 224 is registration for?
retail pharmacy hospital or clinic teaching institution practitioner mid-level practitioner
class ii recall
reversible adverse health reactions
Drugs that should be flushed (p. 124)
risk of accidental ingestion outweighs risk to environment 1. Oxycodone 2. fentanyl patch 3. meperidine 4. methadone 5. morphnie 6. percocet
Neupro
rotigotine patch for Parkinson and RLS Dopamine Agonist
the pharmacist or intern must provide counseling in the following situations
rx has not been dispensed before refill is dispensed in a diff dosage form, strenght, or with new directions if the patient requets counseling when the pharmacist feels counseling is necessary
Emsam vs Eldepryl
selegiline Emsam is a MAO B used for depression Eldepryl is MAO B used for parkinson
drug storage: investigational new drugs
separate from drug stock
drug storage: repackaged or resold drugs
separate from drug stock, assigned BUD date
Delivery of drugs to community pharmacy (p. 117)
signed by a pharmacist If community pharmacy is closed then can receive delivery if: 1. placed in storage facility in the *same* building as the pharmacy 2. only PIC or pharmD designated has access to the facility 3. have a means of telling who has entered facility 4. Written policies and procedures 5. delivery guy documents what was delivered 6. pharmacy responsible for keeping records related to delivery
Delivery to a hospital pharmacy
signed by pharmacist can be delivered to receiving location but must be moved into the pharmacy w/in *1 day after delivery of meds* the pharmD must then *immediately* inventory drugs
Betapace
sotalol Class - 3
transaction statement (TS)
statement that the entity transferring ownership in a transaction is honest and accurate
requirements of a pharmacy/facility/equipment
sufficient size for the safe practice of pharmacy a sink with hot and cold running water readily accessible restroom suitable area for confidential patient consultation safeguards in place to prevent the theft of drugs and devices clean and orderly licenses and current renewal are posted where they can be clearly read by the public
Clinoril
sulindac is a NSAID
Supplier of controlled medications (p. 87) # 10, #11
supplier can provide "partial fills" to the pharmacy of their order MUST supply the balance within *60 days* *Shipments of controlled substances can ONLY be delivered to current DEA registered addresses* (p. 87 bottom) Supplier delivers scheduled drugs in their OWN containers, *separate* from other non-scheduled drugs When the order arrives it can only be checked by the *pharmacist* who records: 1. # of packages 2. date received on copy #3
partial shipment of a form 222
supply the balance within 60 days from the date the form 222 was executed
Protopic
tacrolimus for eczema
Controlled substance inventory
take every 2 years
Flomax
tamsulosin [Sulfa allergy]
Nucynta C2
tapendadol CII C2
What class and BBW is Ketek?
telithromycin Macrolide BBW: Do NOT use in myastenia gravis - respiratory failure
Hytrin
terazosin
Forteo
teriPARAtide injection - parathyroid hormone for men - 20mcg SC Daily - MAXIMUM 2 years of treatment BBW: may cause bone cancer [OSTEOSARCOMA]
Exception from using CA security form for controlled substances:
termially ill (11159.2 excemption) emergency
transaction information (TI)
the TI contains the detailed drug information, such as the drug, NDC #, container size, shipment dates, etc
cr packaging is not required if?
the drug is being administered directly to an institutionalized patient, such as in a hospital or SNF
emergency dispensing of orally authorized schedule ii prescriptions is permitted if
the immediate admin of the drug is medically necessary no alternative treatment is avail it is not feasible for the prescriber to provide a written prescription at that time
misbranded?
the ingredients differ fromt he standard at strengh, quality or purity, as determined by the test laid out in the USP monograph. Probelm with package/ not folloiwng requirement of poison prevention packaging act.
it is permissible to share PHI with
the patient other people authorized by the patient TPO purposes part of a limited data set for research for a public health need
CII partial filling allowed when
the pharmacy is unable to supply the full quantity the prescription is for a terminally ill patient the prescription is for an inpatient of a SNF
drug recalls: if the drug is dispensed to the pharmacy, notify
the pharmacy, who must notify the prescriber or patient. if the patient notifies the prescriber, the prescriber must ensure the patient is notified
drug recalls: if dispensed to the prescriber, notify
the prescirber, who must ensure the patient is notified
emergency refills without the prescriber's authorization is allowed for non-scheduled and schedules iii-v drugs if?
the prescriber is unavailable to authorize the fill failure to refill the rx might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well being the pharmacist must have made a reasonable effort to contact the prescriber
schedule iii- v prescriptions can be faxed and used as the original prescription as long as?
the prescriber signs the rx before faxing it
if the ADDS has removable pockets/drwaers, the stocking is done outside the facility (at the pharmacy) and delivered back to the facility
the removable pockets must be transported in a secure, tamper-evident container the restocking is done by a pharmacist, intern, or tech
when is a form 222 not required?
the schedule II drug is being dispensed to the patient the schedule II drug is being transferred from the central fill pharmacy to the retail pharmacy
Injection site :
thigh and abdomen adalimumab, etanercept (+upper arm) sumatriptan: thigh upper arm abdomen enoxaparin fondaparinux
WTF is Ticlid?
ticlopidine is an P2Y12 antagonist Risk of neutropenia Risk of hematopoietic disorders
Laudanum C2
tincture of opium super antidiarrhea CII C2
*Institution Form*: Under health & Safety Code Section 1250 Designated prescriber at a facility that has 25+ physicians Ideal for places with many residents and floating physicians Takes a long time to order and get Rx pads made w/ preprinted info on them (p. 94-95)
to order security prescriptions forms for their facility that do NOT include pre-printed prescribers --name --category of licensure --license DEA number --address of prescribing practioner These Rx pads will be signed out by the designated prescriber in a record book This record book must be kept in the health facility for *3 years*
Detrol
tolterodine
A pharmacy can sell controlled substances to other pharmacies or prescribers without being *registered as a distributor* if: (p. 107)
total number of dosage units does NOT exceed *5%* of the total number of controlled substances dosage units dispensed per calendar year *Schedule II drugs* Form 222 Seller responsible for sending copy #2 of form 222 to the DEA *by the end of that month*
exempt to license renewal disclosure
traffic infarctions < $300 that do not involve alcohol, drugs pharmacists licensed before 2001 must be re-fingerprinted for their next renewal
DATA of 200 allows?
trained practitioners to prescribe or dispense schedules III-V drugs to treat opioid addiction outside of opioid treatment programs. X replaces first letter of DEA number
Kenalog
triamcinolone
Zontivity
vorapaxar indirect antiplatelet
Medication error investigation
w/in 2 days of error
ordering schedule iii-V drugs
wholesaler or distributor's ordering system CSOS
CMI leaflets must be provided when?
with every drug each time a NEW rx is dispensed developed by third party vendors and NOT fda approved
the partial fill is requested by the patient or the practitioner that wrote the prescription. deadline to fill remaining balance?
within 30 days after the issue date
partial filling for terminally ill patients/LTCF residents. what's the deadline to fill the remaining balance
within 60 days
pharmacy unable to supply the full quantity of CII. what is the deadline to fill the remaining balance?
within 72 hours after the first partial filling
partial filling of an emergency oral rx. deadline to fill remaining balance?
within 72 hours after the issue date
a substitution cannot be made if the prescriber
writes or verbally says "DNS checks off the box initials the box
*Centralized* Pharmacies must renew a specialty license every...
year
In CA, when picking up for a prescription, when do check the patient's ID? Is it allowed for patient's friend or family to pick up the medication?
you check patient's ID when the prescription was transferred via fax or phone. it is allowed for patient's friend and family to pick up the meds (NCS and CS)
SubQ injections (p. 59)
≥ 12 months old: fatty tissue over the triceps < 12 months old: anterolateral thigh muscle 23-25 gauge needle 45ºangle
How much prednisone will make you immune-suppressed?
≥ 2mg/kg/day for ≥ 2 weeks ≥ 20mg/day for ≥ 2 weeks
IM injections (p. 59)
≥ 3 yrs: deltoid < 3: anterolateral thigh muscle Deltoid and thigh: for small volumes Gluteus Maximus: for large volumes 90º angle 2 fingers width *below* the acromion proces Length of needles: 5/8 - 1.5 inch needles