Exam #3 - PNN - Law, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE law, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE, CPJE
Update BOP with email
-within 60 days of becoming licensed and -within 30 days of changing email address.
What is the CE hours requirement for the 1st license pharmacist renewal after graduation?
0 hours
Outpatient Pharmacist to Technician
1 : 1
Inpatient Pharmacist to Technician
1 : 2
ratio of pharmacists to techs in hospital setting
1 pharmacist to 2 techs
Amount of time the record of QA (Quality Assurance) review should must be kept in the pharmacy
1 year
How long to keep records? Med error/quality assurance reports
1 year
expiration date for extemporaneous unit dose preparations
1 year or less if expires sooner per manufacturer
when does an Rx expire
1 year unless controlled, then 6 mo
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"*
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)*
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*
Prescribing authority (Dentist)
*independent authority* CII - CV, limited to scope of practice Req DEA license
Prescribing authority (Podiatrist)
*independent authority*, limited to scope of practice CII - CV, limited to scope of practice Req DEA license
Naloxone Furnishing
- Must complete 1 hour CE - Pt counseling can not be waived - Provide board approved fact sheet
EC can be obtained by three options, and which are covered by insurance
- OTC - Rx (covered by insurance) - furnished per protocol by a pharmacist (covered by insurance)
Which US territories are the same as US states for filling prescriptions?
- Puerto Rico - Guam - Virgin Islands - America Samoa
Epi prescription should include
- name of person indicated - designation "section 1797.197a responder" and "first aid purposes only" - dosage, use, and expiration date
Advanced Practice Pharmacists (APh) can do...
- patient assessment - order and interpret labs - refer patients to other providers - initiate, adjust, and dc drug therapy (including controlled substance if registered with DEA)
Emergency drug supply must be
- portable - sealed by a pharmacist - have list of contents on outside cover - earliest expiration date of any drugs inside
Screening questions for nicotine replacement therapy
- pregnant = do not furnish - heart attack with last 2 weeks, arrhythmias, chest pain = furnish with caution, refer to provider - nasal allergies = avoid nasal spray - TMJ dysfunction = avoid gum
If rph declines to fill a rx and BEFORE he decides it is fraudulent what can he do with the rx?
- retain it - return it - copy it and return it - give 3 days worth until can speak to doctor (not CII)
SC injections where and what needle
- triceps - 5/8 INCH with 23-25 GAUGE needle at 45 degrees
Services APh can perform
-Administer drugs/biologics -Initiate/adjust/dc drug therapy (controls with DEA registration) -Self-administered hormonal contraceptives, rings, injections -Travel meds (not requiring diagnosis) -Nicotine replacement products -Independenly administer immunizations (per CDC) -Order and interpret tests
APh Required for license (3)
-Complete residency program -Provided clinical services >1yr under CPA -Earn certificate in relevant area (oncology, critical care, pharmacotherapy, etc)
What to do after self-assessment is complete?
-Create action plan to correct any non-compliance. -Keep form on file (do not send it anywhere) for 3 years
Patient Counseling must include... at minimum (3)
-Directions for use and storage -Importance of compliance -precautions and relevant warnings (common, severe SE)
Med Guides required for these classes of drugs -adverse events when taken with alcohol (3)
-Disulfiram and other drug causing disulfiram-like rxn (chlorpromide, metronidazole) -MAOI -nitrates
Delivery of blood clotting agents: 1. non-emergency situations 2. emergency situation
1. Within 2 business days 2. Patient lives <100 miles of major metropolitan airport -> within 12 hours. Patient lives >100 miles of major metropolitan airport --> 1 day
Latanoprost 1. Brand 2. aux labels (2) 3. standard dosing
1. Xalatan 2. Protect from light, store unopened in refrigerator (opened at RT x 6mo) 3. 1 gtt into affected eye(s) QD
1. "should" 2. "shall"
1. a recommendation 2. you must do
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
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
Auxiliary labels (p. 29)
1. evidence based 2. simple language 3. Other language can be provided on the bottle OR in supplemental documents
CS inventory counts 1. C1-C2 2. C3-C5 with 1,000 units or less 3. C3-C5 with > 1,000 units
1. exact count (every 90 days) 2. estimated count (at least every 2 yrs) 3. exact count (at least every 2 yrs)
Sxs of Opioid Overdose
1. extreme or unusual somnolence 2. Respiratory difficulty (slow shallow breathing to respiratory arrest) 3. Miosis (pinpoint pupils) 4. Bradycardia
Actiq 1. generic 2. indication 3. dose
1. fentanyl lollipop 2. breakthrough cancer pain in patients *16 and older* 3. 200mcg lozenge - 4/day max
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
2. Furnish *self-administered* hormonal contraceptives
1. oral formulations 2. transdermal patch 3. Vaginal ring 4. Injection (depo provera)
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
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*
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*
1. Can RPh fill rx from out-of-state md? 2. Can RPh fill rx from out-of-country md? (4 "exceptions")
1. yes - if the prescriber has a license equivalent to that of a CA provider 1. no. Except: DC and US territories (Puerto Rico, Virgin Islands, Guam, American Samoa)
Tylenol#3 prn TID, #30 with 5 refills? Ok to fill?
10 day supply x 5 refills = 50 day supply. Ok to fill.
What is the composition of the BOP?
13 members, 7 of which are pharmacists
time you have to report to the board of tampering or damage or theft of a removed liner of the med take back bin
14 ays
If pharmacist is suspected of intoxication, must report to board within.....
14 days
How many days does pharmacy have to appoint new PIC if board disapproved original candidate
15 days
How long do you have to return your license if it changes?
15 days of receipt of new license
What is the mile limit for a supervising pharmacy over a remote dispensing site?
150 miles
What is the pharmacy intern hours requirement?
1500 hrs
pharmacist intern hour requirement
1500 hrs
How old do you have to be to purchase dextromethorphan?
18
age requirement for pharmacist
18
pharmacy name tag font size
18
What point font is required of badges?
18 point minimum
Technician trainee ratio
1:1 only
Pharmacist to intern ratio
1:2
pharmacist to intern ratio
1:2
How many interns can a pharmacist supervise at the same time?
2
number of interns a pharmacist can supervise
2
How long does the pharmacist have to undergo QA investigation after a med error?
2 days
for licenses renewed after july 1, 2019, need this
2 hours of pharmacy law and ethics for each renewal
how much CE to furnish NRTs
2 hours x1 or in school BUT also need "ongoing CE focused on tobacco cessation every 2 years" does not specific amount of CE needed
Continued education requirement after July 1, 2019
2 hrs pharmacy law and ethics
PIC can supervise __ pharmacies
2 pharmacies within 50 driving miles
How many tablets of Overette fo you need to give for emergency contraception?
20 tablets Overette
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
Expiration day of Epogen?
21 days after puncture
Which DEA form is used for ordering, distributing, and transferring of C-II drugs?
222
Technician : pharmacist ratio at a hospital pharmacy
2:1
number of pharmacies PIC can supervise
2; must be within 50 miles of each other
When to use EpiPen Jr?
2nd grade or below or <66lbs
optometrists max day supply for codeine combination products and hydroconde combination products?
3 day supply
If NuvaRing falls out insert back within...
3 hours
Biennial controlled substances inventory
3 years
Central location recordkeeping for controlled substances
3 years
Community or Clinic pharmacy Rx's
3 years
Compounded drug record time requirement
3 years
Controlled substance inventory
3 years
Copy of non-controlled Rx held for __ years in hospital
3 years
DEA 222, power of attorney forms
3 years
Pharmacy Tech Compliance Records
3 years
Prescription kept for __ years
3 years
Self-assessment forms
3 years
Controlled Substances inventory
3 years (California), 2 years (Federal)
How long are records kept?
3 years from date created
Pseudoephedrine Limits
3.6 grams per day 9 grams in 30 day period 3 packages per transaction
Within how many days must the board be notified of a change of address or name
30 days
time the pharmacy and departing PIC has to report change to the board
30 days
time you have to tell the board you started a drug take back service
30 days
time you have to tell the board you stopped your med take back service
30 days
Drug supply inspection within hospital performed how often and how long to keep record
30 days, records kept for 3 years
What is the CE hours requirement for the 2nd and all subsequent pharmacist license renewals?
30 hours
RPh CE hour requirement
30 hrs every 2 years
How long can pharmacy be without pharmacist?
30 minutes
If there's only ONE pharmacist, how long for lunch break?
30 minutes
max amount of time pharmacist may leave the pharmacy and leave non-pharmacists in pharmacy
30 minutes
time a pharmacist has to take a break when he she is the only pharmacist in the pharmacy
30 minutes
How long does an RPh have to take a break.
30 minutes.
How many ND's can a physician supervise?
4
NuvaRing can be at room temperature for...
4 months
If a pharmacist resigns, how long can there be a temporary PIC?
4 months - 120 days
Temp PIC length?
4 months and notify BOP. If reject, then 15 days to find PIC.
Certificate of completion for CE
4 years
Certification of completion of CEs kept for __ years
4 years
PIC can supervise 2 pharmacies if they are this distance apart
50 driving miles
Patient acknowledgement of HIPAA
6 years
time you have to keep transaction info for most Rx drugs
6 years
How long can a terminally ill pt fill CII?
60 days from writ
Limit for ER giving a controlled medication to a patient for home supply
72 hour supply max
How long do you have to report to BOP if you suspect counterfeit product?
72 hours
When must a CII order be completed if a partial was given
72 hours
Within how many hours must the SBoP be notified of a reasonable cause to believe that a dangerous drug or dangerous device in, or having been in, the possession of a pharmacy is *counterfeit* or the subject of a *fraudulent transaction* ?
72 hours
Normal body temperature
97.8 - 99 F
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
What can a prescriber prescribe to: 1. himself? 2. His family?
1. Any non-controlled med 2. Any non-controlled or controlled med
Health Screenings (p. 73)
1. Body fat analysis 2. BP 3. Cholesterol 4. DM 5. Tobacco use 6. Bone density 7. Depression
Submitting dispensing data to CURES 1. What to submit? 2. how frequently?
1. C2-*C4* 2. weekly
DATA 2000 allows trained practitioners to prescribe and dispense __1__ to treat opioid aditoinc outside of an opioid treatment program. 2. Who can prescribe Suboxone, etc? 3. What must be on the rx?
1. C3-C5 2. Only a physician! 3. DEA# and X-DEA#
ADDS in a clinic 1. Clinic must be located in... 2. ADDS must be registered with BOP within...(3) 3. Who inventories, restocks, cleans, maintains, monthly inspects? 4. For a drug to be removed from ADDS in a clinic: (3) 5. Who restocks? 6. Who is responsible for ADDS?
1. CA 2. within 30 days of installation, renewed annually, notify BOP within 30 days of d/c 3. RPh only 4. -RPh must authorize -RPh must review pt profile for DDI, CI, etc -*First fill*, RPh must consult via telecommunication or in person 5. RPh - unless removal pockets/cards/drawers - can be refilled by intern, tech, nurse (checked by RPh) 6. RPh
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)
DEA Form 222 1. Supplier keeps 2. DEA keeps 3. Purchaser keeps
1. Copy 1 (brown) 2. Copy 2 (green) 3. Copy 3 (blue)
Mid-level prescribers (RPh, CNM, NP, PA) 1. Prescribing authority
1. Dependent: C2-C5
ADDS in Community Pharmacy 1. aka 2. What can be dispensed? 3. location 4. what must patient do? 5. Who is responsible for ADDS? 6. Who can restock?
1. Dispensing systems 2. Only refills (no consultation needed) 3. adjacent to pharmacy 4. sign written consent 5. The pharmacy 6. RPh, intern, tech (under direct supervision of RPH)
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
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
Med Guides 1. Approved by? 2. Written by? 3. When to provide to patients? (5)
1. FDA 2. Mfg 3. -Every time (new AND refills) dispensed in outpatient setting. -Every time the pt will use w/o supervision of HCP. -First time drug is being dispensed to a HCP for admin to a pt in the output setting -When pt/caregiver asks for it -if MedGuide has been revised
Cannot Substitute (p. 43)
1. Long acting to short acting 2. Combination drug products to multiple single agents
11159.2 exemption
A controlled drug may be on a regular RX if for a terminally ill patient. If the prescriber writes or is typewritten 11159.2 exemption on the script
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
Thieves stole Norco from pharmacy. Who to contact?
DEA immediate. BOP 14 days.
Which category of medications always need a patient package insert?
ALL estrogen products
how many days must board be notified in case of bankruptcy, insolvency or receivership?
ASAP in writing
Above how many price inquiries can you start charging and ask for time?
Above 5 (6 or more)
Which diabetes meds can be at room temp for 28 days?
All rapid acting insulins (lispro, aspart, glulisine) Glargine (LANTUS) Bydureon
Where are the three DEA form 41 copies sent?
All to the DEA
Is there an age restriction to Next Choice One Dose?
Also true for My Way and Levonorgestrel tablets. Anyone age 17 or older can buy them. If 16 or younger an Rx is needed.
What can a pharmacy inspector do?
Arrest without warrant They don't have to be a pharmacist
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"*
If requesting medical records, how long can a patient wait to receive them?
Be able to inspect medical records within 5 business days and receive copies within 15 business days.
Patient package inserts
Estrogen-containing drugs Community: EACH TIME drug is dispensed Inpatient: prior to 1st dose and every 30 days thereafter Approved by FDA
If the pharmacy offers compounding, how often must pharmacist/technician must be tested for proficiency every ________?
Every 12 months, and the records of proficiency tests must be kept for 3 years.
Biennial
Every 2 years
How often to renew RPh license
Every 2 years. If not renewed within 3 yrs, it is cancelled.
License renewal of RPh?
Every 2 years. Must renew within 3 yrs of expiration
How often is pharmacy's EMR software audited?
Every 2 yrs or whenever there is a change in system
Period one must renew license to continue to practice pharmacy
Every 2 yrs. If license not renewed within 3 yrs of date renewal was due, it shall not be renewable
How often do you have to count C-II's?
Every 3 months
How often would a DEA pharmacy license be renewed?
Every 3 years
How often should hoods be certified?
Every 6 months
Frequency of C2 inventory reconciliation. Count? Keep records for?
Every 90 days. - exact count! Keep records x 3 years.
Pharmacy Self Assessments
Every odd year on July 1st
Self-assessment form
Every odd-numbered year before July 1st
Under no circumstances are pharmacies to accept internet prescriptions for Schedule II, III, IV, V controlled substances unless sent under the "E-prescribing program"
Exception does exist allowing for the electronic transmission from SNF to pharmacy
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
Are CIIs separated from CIII-V when filing?
CIIs are to be filed separately. CIII-V are filed together, separately, OR integrated into the non-scheduled rx record files. If CIII-V are filed with non-controlled, then must have a one inch red letter "C" in lower right hand corner of rx (not needed if electronically filed.)
refills for controls
CIIs will never have refills CIIIs-IVs have up to 5 refills within 6 months or 120 day supply of refills (whichever less) note: refill restriction does not apply to CVs
What is a labelling requirement for a chemo drug?
CONTAINS CYTOTOXIC AGENT
Self-prescribing or for family members
Can self-prescribe non-controlled Can prescribe NC or C to family member as long as there is valid physician/patient relationship, legitimate medical purpose, and good faith exam
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)
What is the requirements for dry conditions?
Cannot exceed 40% humidity
Rx from another country
Cannot fill Rx from other country. Pharmacist can fill Rx from D.C and the U.S. territories (Puerto Rico, Virgin Islands, Guam, American Samoa)
Maintain x at least 4 yrs
Certificate of completion for CE
Authorized Prescribers (dependent authority)
Certified Nurse-Midwife (CNM) Nurse Practitioner (NP) Physician Assistant (PA)
Optometrist prescribing drugs
Certified with Board of Optometry, with T at end of license number Codeine or hydrocodone products max 3-days
Therapeutic interchange
Chemically different but therapeutically similar
Protect from light
Cipro Lasix Levaquin Amiodarone Amphotericin Mycamine Phytonadione Doxycycline Flagyl Flolan Nitropress (CLLAAMPD FFN)
What does CLIA stand for?
Clinical Laboratory Improvement Amendments
REMs
Clozapine Isotretinoin Qsymia Forteo Addyi Saxenda, Symlin Thalidomide ER/LA opioid analgesics (CIQFASTE)
Can MD self-prescribe codeine and promethazine cough syrup?
Codeine containing cough syrups is a schedule V drug. In California, prescribers may self-prescribe for non-controlled substances only. Prescriptions must be written for legitimate medical purposes, there should be a recorded physician/patient relationship, and a good-faith examination performed.
Things to know about unit dose medications
Expiration is one year or sooner. Lot#. Barcoded. Name. Strength.
T/F You can never put false or misleading information on a label
False. You can if it's for a study on an investigational drug
Vinca alkaloids label
Fatal if given other routes - Must give IV
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
What happens if a pharmacy files bankruptcy? How long do they have for things?
Contact BOP within 72 hours Records kept in a board-licensed facility for at least 3 years
What should you do first after a med error?
Contact the patient and physician immediately
What is CSOS?
Controlled Substance Ordering System This is an electronic DEA 222
MD checks "Do Not Substitute" with no initial on ELECTRONIC copy. What to do?
Fill prescription , for an electronic prescription only a check mark in the box is required without the accompanying initial of the prescriber
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
Can hospitals dispense meds?
Generally, no 72 hours limit
How should a generic drug be written?
Generic name Generic for brand name Manufacturer!!!
What if inspector asks for a prescription?
Give it immediately and keep a photo copy
A male customer with TMJ is requesting nicotine replacement therapy. Which one will the pharmacist least likely to furnish?
Gum
Who do you need to report med errors to?
ISMP Institute of Safe Medication Practices
Route of vinca alkaloids
IV only. Fatal if given intrathecally.
Maintain x least 7 yrs
Hospital pharmacy chart order records for controlled substances
Which diabetes meds can be at room temp for 31 days?
Humulin R/N/combos
How should generic Norco read on a label?
Hydrocodone/APAP, Mylan (MFG needed)
What schedule is Provigil
Modafinil is C-IV
How often are automated drug delivery systems inventoried by RPh?
Monthly
How often does an Rph have to inspect an automated system?
Monthly
Unit dose medication produced by a centralized hospital packaging pharmacy BARCODE should retrieve what information?
(a) The date the medication was prepared. (b) The components used in the drug product. (c) The lot number or control number. (d) The expiration date. (e) The National Drug Code Directory number. (f) The name of the centralized hospital packaging pharmacy
Record Keeping and reporting requirements
(p. 124)
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*
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
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
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
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 (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 (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)
To furnishing naloxone pharmacist must...
- 1 HOUR of continued education or equivalent curriculum-based training during pharmacy school - ask if recipient uses opioids or knows someone who does - ask if recipient has known naloxone hypersensitivity - provide recipient with training - patient counseling CANNOT BE WAIVED - provide board-approved Fact Sheet - with patient's permission, notify the patient's PCP - keep records for THREE YEARS
To furnish self-administered hormonal contraceptives pharmacist must...
- 1 HOUR of continued education or equivalent in pharmacy school - ask patient to complete self-screening form initially and ANNUALLY, or when MAJOR HEALTH CHANGE - measure BLOOD PRESSURE if requesting combined hormonal contraceptives - THREE fact sheets (FDA birth control guide, patient product information, administration fact sheet) - refer to PCP or nearby clinic for follow up - keep records for 3 YEARS
Requirements to be a Pharmacist
- 18 years old + - Graduated pharmacy school - Pass NAPLEX and CPJE - Pass background check
Requirements for licensure
- 18 yo - ACPE-accredited school of pharmacy - 150 hrs college credit, 90 of which from pharmacy school - have a baccalaureate degree devoted to pharmacy - 1500 hrs pharmacy practice experience, 900 of which in both community and hospital pharmacy - passed NAPLEX and CPJE
What are the requirements to receive drugs for dying with dignity?
- 18+ yo - Mentally competent - CA resident - Diagnosed with terminal illness that will lead to death in 6 months
To furnish nicotine replacement therapy pharmacist must...
- 2 HOURS continued education or equivalent within last two years - continued education EVERY 2 YEARS - review current use and past attempts to quit - screening questions - keep records for 3 YEARS
RATIOS 1 PHARMACIST:
- 2 INTERNS - COMMUNITY - 1ST RPH: 1 TECH; 2ND RPH: 2 TECHS - INPATIENT - 1ST RPH: 2 TECHS; 2ND RPH: 2 TECHS - 1 TRAINEE - REASONABLE # OF CLERKS
What are the requirements for pharmacists to furnish nicotine replacement products?
- 2 hours of CE on smoking cessation or training at SOP in the last 2 years - Maintain CE every 2 years - Reviews patient's current tobacco use and past quit attempts - Series of screening questions about pregnancy and CVD - Counsels patients - Notifies PCP - Keep furnishing records for 3 years
Providers of blood clotting products for home use must have...
- 24 hour on-call service every day - screen telephone calls for emergencies - acknowledge all calls within 1 hour - pharmacy staff on-call for emergency requests - ability to obtain all FDA-approved blood clotting products in multiple assay ranges and vial sizes - supply ancillary infusion equipment with each Rx as needed - ship to patient within TWO BUSINESS DAYS
What is the max restrictions for buying sudafed?
- 3.6 grams per day - 9 grams per 30 days or 7.5 g per 30 days via mail order - 3 packages per transaction - 60 mg per single dose packet *Logbook kept for 2 years
What is the required special layout of a prescription label that must be separate from the rest of the label information?
- 50% of the label area must be listed in the following order: i. Name of the patient ii. Drug name (strength, manufacturer) iii. Directions iv. Condition the drug was prescribed *Must be at least 12 point san serif typeface
Medicare Part D is for...
- 65 years or older - < 65 with disability - ESRD
Annual CMR for Medicare Part D patients enrolled in a MTM program
- ANNUAL comprehensive medication review - adherence to non-insulin DM medications, statins, RAS system medications - high-risk medications for 65 years and older - statin use in DM patients 40-75 years old
What additional responsibilities do licensed pharmacists have NOW as given by SB493?
- Administer drugs/biologics (ALL routes) - Participate in multidisciplinary reviews of patient progress - Furnish self-administered hormonal contraceptives (include oral formulations, transdermal aka Xulane, Nuvaring AND Depo-SQ Provera) - Furnish ROUTINE travel medications recommended by CDC - Furnish prescription nicotine replacement products for smoking cessation - Initiate and administer immunizations to patients 3 years and older - Order and interpret tests to monitor drug therapies
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)
What consists of traditional compounding?
- Altering dosage form - Altering strength - Combining components or active ingredients - Preparing a drug products from chemicals
What criteria is Medicare Part D plans based on?
- Annual comprehensive medication review for patients enrolled in MTM programs - Adherence to non-insulin diabetes meds, statins, RAAS - Appropriate use of high risk medications for > 65 yo - Ensuring statin use in patients with diabetes age 40-75 yo
Drugs that require MedGuides
- Antidepressants - NSAIDs - Some Anti-psychotics - Anticonvulsants - Long Acting Beta Agonists - Most Antiarrhythmics - Insomnia Drugs - ADHD - Retinoids
What are the requirements to be a licensed pharmacist?
- At least be 18 years old - Graduated from a ACPE accredited SOP or a foreign pharmacy graduate certified by NABP's foreign pharmacy graduate examination committee (FPGEC) - Completed at least 150 hours of semester college credit, 90 of which must be from pharmacy school - Passed NAPLEX and CPJE - Passed criminal background check
What are the requirements for pharmacists to furnish naloxone?
- Attend 1 hour of CE or appropriate training in SOP - Ask if the recipient uses opioids - Ask about naloxone hypersensitivity - Counseling, CANNOT be waived - Provide fact sheet - Keep records of furnishing for 3 years
To administer vaccines pharmacist must...
- CDC or ACIP-approved immunization training - BLS certification - 1 HOUR continued education every 2 YEARS
What policies must outsourcing facilities abide by?
- CGMP - Licensed by the FDA - Preparation under the supervision of a pharmacist - Facility must keep records of source of ingredients, sterility and adverse event history
What is the policy for filling out of state prescriptions?
- Can fill scheduled II, III, IV and V for MAIL if prescription fulfills requirements in the original state - Can fill scheduled III, IV and V for in person pick up if the prescription is written on a CA security form or received orally
What are the requirements for pharmacists to furnish travel medications?
- Complete immunization certificate - Complete a travel medicine training program, with at least 10 hours of CE - Complete CDC's yellow fever vaccine course - Have a current BLS - Complete 2 hours of CE every 2 years - Notify the PCP within 30 days - Provide to the patient a progress note of the clinical assessment
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
Which drugs must be separated from the rest of the drugs in the pharmacy?
- Controlled drugs (separate cabinet or throughout the drug shelves) - Investigational drugs - Repackaged drugs - Recalled drugs - Expired drugs - Drug samples
What is required on a centralized hospital packaging label?
- Date of the medication prepared - BUD - Name of the drug - Quantity of active ingredient - Special storage instructions - Lot/control number - Name of the centralized hospital pharmacy
What are the requirements to allow for drug delivery in a community pharmacy when the pharmacy is closed or no pharmacist is on duty?
- Delivery is placed in a secure place in the same building as the pharmacy - There is established protocols for the delivery of drugs to the secure place - Only the PIC or pharmacist can access the storage facility - Capable of knowing someone has entered the storage facility after delivery - The person delivering the drugs leaves documents indicates the name and amount of drug delivered
What counseling points MUST be addressed by a pharmacist?
- Directions for use and storage - Importance of compliance with directions - Warnings and common side effects
When performing traditional compounding, what exemptions do traditional compounded products have?
- Do not need to comply with CGMP - No labeling with adequate directions for use - No need for New Drug Application
When ordering schedule III-V, what must be listed on the invoice?
- Drug name - Strength - Formulation - Quantity - Date transferred - Recipient's name, address, DEA number
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
What are the labeling requirements for prescription containers?
- Drug name (and the name of the manufacturer) - Name of the patient - Date of issue - Strength of drug - Directions for use - Quantity - Expiration date (either determined by manufacturer or 1 year after issue date) - Description of the drug - Prescriber's name - Pharmacy and pharmacy's phone number
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
When are exceptions in receiving an oral prescription for a schedule II?
- Emergency to tide the patient over - Patient resides in a skilled nursing facility, intermediate care facility, home health or a hospice i. SAME goes for a faxed prescription, allowed if patient is in a long term facility
What are the requirements to be a intern pharmacist?
- Enrolled as a student in a pharmacy school that is ACPE accredited school - Be a graduate of an accredited SOP awaiting licensure - Be a graduate of a foreign pharmacy school who has obtained certification from NABP's FPGEC
Tests that can be performed in community setting
- FPG - CardioChek for cholesterol - ultrasound densitometer for T-score - PHQ-9 for depression
What are the requirements for pharmacists to furnish hormonal contraceptives?
- Give self-screening form to screen for disease and drug contraindications - Measure seated blood pressure (CI >160/100) - Ensure patient is counseled - Furnish THREE fact sheets i. Birth control guide from FDA ii. PPI iii. Administration Fact Sheet - Refer to PCP for follow up - Keep records for 3 years
What are the requirements for a pharmacy able to dispense blood clotting products for home use?
- Maintain a 24 hours on call service 24/7, every day of the year - Have the ability to obtain all FDA approved blood clotting products - Supply ancillary infusion equipment - Ship blood products and equipment within 2 business days
What is required to be a mobile pharmacy during emergencies?
- Mobile pharmacy shares common ownership with a pharmacy in good standing - Retains dispensing records - Run by a pharmacist - Reasonable security measures to safeguard drug supply - Located in emergency area - Will cease activity within 48 hours after emergency is over
Furnishing Nicotine Replacement Therapy
- Must complete 2 hour CE - 1 hour of continuing CE every 2 years Records are kept for 3 years
What are the requirements for pharmacists to furnish EC under protocol?
- Must have undergone 1 hour of CE on EC - Furnished to a woman - Asked about intercourse timing to assess EC appropriateness - Must furnish a EC fact sheet for ALL EC furnished regardless of OTC, Rx or protocol
What is the policy of receiving the original prescription for an emergency filling of schedule II?
- Must receive an original prescription by the 7th day postmarked - The Rx must state it was for emergency dispensing - If no prescription by the 7th day, must report to the CA bureau of narcotic enforcement within 144 hours
Who needs to be reported to when reporting a loss or theft of controlled substances and how quickly?
- Must report to the DEA within 1 day of loss - Must report to board of pharmacy within 30 days
When stocking a ADD (automated dispensing devices), what must be on the drug label?
- Name of drug - Strength - Dosage - Manufacturer - Lot number - Expiration 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
What are the requirements of a prescription?
- Name of the patient - Address of the patient (can be on file on the computer) - Name and quantity of the drug - Directions for use - Date of issue - Prescriber info i. Name, address, telephone ii. Prescriber's license class iii. DEA number, if controlled - Condition or purpose of drug, it patient requests - Prescriber's signature (signature and date MUST be written physically by the prescriber) *For Vets, prescriptions must state kind of animal, name and address of the owner
During emergencies, what information does the pharmacy have to keep for records?
- Name of the patient - Date - Patient's address - Drug name - Strength - Quantity
What must be dispensed on a epinephrine label?
- Name of the person to whom the epinephrine is issued for - "First Aid Purposes Only" and Section 1797.197a responder - Dosage, use and expiration date
What are the requirements for a prescription transfer?
- Names of the pharmacists involved - Identification code (store number) or address of the pharmacy - Original issue date and last dispense date - Number of refills and date originally authorized - Number of refills transferred
What are the requirements for being a technician?
- Obtained an AA in pharmacy technology - Completed a course of training specified by the board - Graduated from a SOP recognized by the board - Received certification from the PTCB
Requirements to purchase OTC EC
- One-Step has no restrictions - Two-tablet products allowed for 17 YEARS OR OLDER, and must be BEHIND PHARMACY COUNTER
To Dispense Emergency Contraception
- PharmD must complete 1 hr of CE - EC Fact Sheet must be provided
When can you partially fill a schedule II?
- Pharmacist unable to fill full amount (must be given the rest within 72 hours) - Prescription is for terminally ill - Prescription is for inpatient SNF
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
How are controlled drugs counted during an inventory?
- Schedule I and II needs exact counts - Schedule III-V with < 1000 dosage units: estimated - Schedule III-V with > 1000 dosage units: exact count *Must be available for inspection every 3 years
Which sources can donate drugs for redistribution?
- Skilled nursing - Home healthcare - Board and care - Mail order *No controlled meds can be donated *All meds must be unopened and never dispensed to a patient
What are the exceptions for NOT writing controlled substances on a Security form?
- Terminally ill patient (with written exemption 11159.2 exemption) - Emergency furnishing
In order to be applicable for centralized packaging for the pharmacy's hospital, what are the requirements?
- The hospitals must be under common ownership - Hospital within 75 miles of each other
Which agents can you share PHI with?
- The patient - Other healthcare providers involved in care - For treatment, payment or operation reasons - For persons authorized by the patient - Limited research - Public health need, drug abuse issues, the DEA, the medical board inspectors, adverse drug reactions to the FDA
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
What traits are required on a controlled security form?
- When scanned, the word void appears - Watermark on the back that reads "California Security Prescription" - Chemical void protections that prevents alteration - Thermochromic ink that does not duplicate - An area of opaque writing - Description of security feature - 6 quantity check off boxes - Statement that says "prescription void if number of drugs not noted" - Date of origin - An identifying number assigned to the approved security printer by DOJ
SB 493 expanded scope of practice for ALL REGISTERED PHARMACISTS
- administer drugs and biologics when ordered by prescriber - furnish self-administered hormonal contraceptives - furnish travel meds recommended by CDC which do not require diagnosis - furnish Rx nicotine replacement therapy - administer immunizations published by CDC to 3y and older - order and interpret tests
How long for emergency contraception to be effective
- both same efficacy during days 1-3, as labeled - both can be used days 4-5, but ulipristal is more efficacious
503B: outsourcing facility requirements
- cGMPs - licensed by FDA and CA BOP - cannot be licensed as sterile compounding pharmacy at the same time - cannot perform functions of a pharmacy
IM injections where and what needle
- center of deltoid muscle - adults require 1 INCH with 22-25 GAUGE needle at 90 degrees
Pharmacist can initiate and administer ___ for severe allergic reactions
- epinephrine - diphenhydramine
To furnish travel medications pharmacist must
- immunization certification program - travel medicine training program consisting of at least 10 HOURS - CDC'S Yellow Fever Vaccine course - BLS certification - 2 HOURS of continued education every 2 YEARS - notify PCP within 14 DAYS of furnishing
Emergency contraception options
- levonorgestrel (OTC) - ulipristal (Rx only) - high dose birth control pills (off-label)
Mobile pharmacy during emergencies should... and when to cease all activity
- shares common ownership with at least one currently licensed pharmacy in good standing - retains records of dispensing - licensed pharmacist on-site - reasonable security measures for drugs - located within declared emergency area - ceases activity within 48 HOURS after emergency is over
BUD for unit dose containers:
-1 year from date drug is repackaged, OR -exp date on msg's container **whichever is sooner**
Med Guides required for these classes of drugs -impaired ability to drive when taken with alcohol
-Muscle relaxants -Analgesics with CNS depressant effects -Antipyshcs (including phenothiazines) -Antidepressants -All C2-C5 -Anticholinergic
Clustered into 50% of the medication bottle label (4)
-Patient name -Drug name (Brand or (generic + mfg)) AND drug strength -Directions for use -Condition or purpose of the drug in this rx
Used to treat PCP? 3 options
-SMZ/TMP (Bactrim, Septra) -pentamidine (Pentam, NebuPent) -atovaquone (Mepron)
Examples of REMS programs -birth defects (3)
-Thalomid REMS (previously STEPS): (-) preg test required -iPledge (isotretinoin): (-) preg test required -Qsymia (phentermine/ topiramate - wt loss) REMS: only dispensed through certified pharmacies
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
With additional training, pharmacist can administer:
-drugs and biologics when ordered by prescriber (oral, topical, injectable) -sell self-administered hormonal contraceptives -sell travel meds recommended by CDC and do not req diagnosis (ex: anti-malarial rx) -sell nicotine replacement produts -independently initiate and adminster immunizations published by CDC to *3+yo* -order and interpret tests, in coordination of PCPC
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
Drugs stored in ADDS need proper labeling, including: (3)
-name, strength, dosage form of drug -Mfg and mfg lot number -exp date
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
What orders can be transmitted to pharmacist via phone? and by whom?
-non-scheduled -C5 -C4 -C3 -by nurse/secretary. RPh must document who called.
Telepharmacy 1. Supervising pharmacy can supervise ___ remote pharmacies 2. Supervising pharmacy is within ___ miles away. 3. Nearest pharmacist is ___ miles away. 4. Can only dispense ___ rx per day (on ave per calendar year) 5. Consultation?
1 .one 2. 150 road miles. 3. > 10 road miles 4. 225 rx per day 5. Supervising pharmacist consults on every rx (new and refills)
Pharmacist to Intern Pharmacist ratio
1 : 2
Additional pharmacist to technician ratio
1 : 2 e.g. 2 pharmacists = 3 technicians
What training is required for naloxone?
1 CE
What training is required for immunizations?
1 CE every 2 years
how many technician trainees can a pharmacist supervise
1 at a time and only for up to 120 hours
How long for DEA if you LOSE a controlled substance?
1 business day DEA form 106
CE needed for vaccinations
1 hour of CE every 2 years
CE needed to furnish naloxone
1 hour x1 or have school training
CE needed to furnish hormonal contraceptives
1 hour x1 or school raining need to give pt screening form and have them re-do it at least every year
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
Pharmacist: intern: tech: tech trainee ratio
1 pharmacist can supervise 2 interns 1 pharmacist can supervise 1 tech Each additional pharmacist can supervise 2 techs Ratio NOT needed if tech is NOT typing/filling Pharmacist may request less techs to supervise 1 pharmacist can supervise 1 tech trainee NO ratio for pharmacy clerk!!!
What is the ratio of technicians to pharmacists?
1 tech for the 1st pharmacist and 2 technicians for each additional pharmacist In the hospital, it's 2 techs to each pharmacist
tech ratio in the community/outpatient setting
1 tech for the first pharmacist on duty 2 techs for each additional pharmacist on duty
Pharmacy Technician
1 tech: 1 pharmacist each additional pharmacist: 2 techs
How long can a pharmacist supervise a technician trainee?
1 trainee at a time and only for up to 120 hours
How many times can C III - V drugs be transferred?
1 transfer Original hard copy must be pulled and VOID written on it
After approved waiver, how long do non-CS rx records need to be stored in the pharmacy before moving off-site?
1 year
How long are med error reports kept?
1 year
How long do non-controlled records need to be kept on site?
1 year
How long do you have to keep a med error QA report?
1 year
How long does a pharmacy keep QA records?
1 year
How long is a pharmacy permit good for?
1 year
How long should the QA review file of a medication error be kept?
1 year
How long to keep patient med profile?
1 year
How long to keep records? Patient medication profile
1 year
Medication Error/QA reports
1 year
Non-controlled records can be MOVED to off-site storage after
1 year
Patient Medication profile
1 year
Patient medication profile
1 year
QA reviews records maintained on premises when
1 year
What is the expiration date of an extemporaneous unit dose med?
1 year
When can non-controlled records be moved off-site?
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 are non-scheduled drug Rx be valid for?
1 year from issue date
How long must patient medication records be kept for?
1 year from the last dispensed drug date
QA review on medication errors must be kept for ___
1 year on site
What is the expiration date of Unit Dose Preparations?
1 year or less depending on the manufacturer's expiration.
How long to keep patient medication profile?
1 year. Also 1 year is QA
How long is permit for pharmacy good for?
1 year. Renew yearly - 30 days to submit if new pharmacy
Non-controlled substance Rx need to be kept AT THE PHARMACY for how long?
1 year; afterwards can be kept offsite for 2 years
Unit dose expiration?
1 yr or less
Expiration date for extemporaneous unit dose preparations
1 yr or less if manufacturer's expiration date is less than 1 year
What is the procedure for receiving medication for dying with dignity?
1) Patient must submit the 1st ORAL request to the physician 2) Patient must wait 15 days and submit the 2nd ORAL request to the physician 3) Patient must submit a written request to the physician 4) After receiving ALL THREE requests, prescription can be written 5) Patient must complete final attestation form within 48 hours before taking the medication
Two cases an oral prescription for schedule II drugs are valid
1) in an emergency situtation 2) if the patient is a resident of a licensed skilled nursing facility, an intermediate care facility, a home health agency, or a hospice
Which of the following can prescribe schedule II drugs independently? 1. Physician 2. Podiatrist 3. Veterinarian 4. Dentist 5. Optometrist 6. Naturopathic doctors 7. Nurse practitioner/physician assistant/certified midwife 8. Pharmacists
1, 2, 3, 4
Optometris (OD) 1. License distinction 2. Prescribe controlleds?
1. "T" end of the license number 2. codeine- and hydrocodone- and tramadol- containing meds for a max of 3 day supply
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
CE Requirements for extra RPh stuff 1. Administering immunizations 2. Self-administered Hormonal Contraceptives 3. Naloxone 4. NRT 5. Travel meds 6. APh
1. 1-hr CE Q2yrs, CDC/ACIP approved immunization program, BLS; 2. 1-hr CE 3. 1-hr CE 4. 2-hr CE Q2yrs 5. 2-hr CE Q2yrs, immunization cert program, travel med training program (10+ hrs), Yellow Fever VAX Course, BLS 6. 10 additional CE in relevant area of practice each renewal cycle
Outsourcing comopund recalls 1. Contact pharamcy/provider/patient within... 2. Contact BOP in..
1. 12 hours 2. 12 hours
BOP is notified within xxx time frame for: 1. Recall on a compounded product 2. ADR from a compounded product 3. Employee theft 4. Non-employee theft/loss
1. 12 hours 2. 12 hours 3. 14 days 4. 30 days
BUD: 1. Aqueous oral compound 2. Aqueous topical (cream, gel) 3. Unit dose exp
1. 14 days refrigerated 2. 30 days 3. 1 yr or less
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
1. Normal BMI 2. Waist circum goal for women 3. Waist circum goal for men
1. 18-25 2. <35 3. <40
Furnishing travel medicine requirements
1. 2 CE's every 2 years 2. 10 hours of travel medicine training program 3. CDC Yellow Fever Vaccine course 4. BLS
Pseudoephedrine "OTC" sales 1. Max per day 2. Max per month 3. Max per mail-order customer/30days 4. Max packages/transaction 5. storage? except? 6. mg pseudophed/tab: Allegra-D 12H 7. mg pseudophed/tab: Allegra-D 24H 8. mg pseudophed/tab: Zyrtec-D 9. mg pseudophed/tab: Claritin-D 24H Where can ephedrine be found?
1. 3.6g/day 2. 9g/month 3. 7.5g/30 days 4. 3 5. behind counter. Except pseudoephedrine 2 x 30mg caps single use (OTC, no ID req'd) 6. 120mg/tab 7. 240mg/tab 8. 120mg/tab 9. 240mg/tab Asthma products
Upon written request, patient records: 1. Pt can inspect their medical records within... 2. Receive copies of their medical records within...
1. 5 business days. 2. 15 business days.
Valid rx good from written date: 1. Controlled substances 2. non-controlled
1. 6 months 2. 1 year
FDA MedWatch is notified within xxx time frame for: 1. ADRs on recalled products 2. ADRs on compounded products
1. 72 hours 2. 72 hours *note: do not need to contact MedWatch on recalled product UNLESS there is an ADR*
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
How do you do a check digit on a DEA number?
1. Add digits 1,3 and 5 2. Add digits 2, 4, and 6 3. Multiply the sum in step 2 by 2 4. Add steps 1 and 3 5. The last digit of the sum should match the last digit in the DEA number
CIV (p. 85)
1. Armodafinil (Nuvigil) 2. *Benzodiazepines* 3. Lunesta 4. Lorcaserin (Belviq) 5. Tramadol 6. Zolpidem (Ambien)
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
Rx Transfers 1. Non-controlld 2. C3-C5 3. C2
1. Can transfer as many times as there are refills remaining 2. one transfer, unless sharing a computer EMR system (CVS-->CVS) 3. No transfers
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
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)
What are the 3 types of written information given to patients?
1. Consumer Medication Information Leaflet 2. Patient Package Inserts (i.e. estrogen containing products aka birth control) A. Given to the patient when... i. EACH time a drug is dispensed ii. Prior to admin of the 1st dose and every 30 days after in the hospital 3. Medications Guides A. Given to the patient when... i. Every time drug is dispensed in the outpatient setting ii. First time drug is administered iii. When patient asks for it iv. Medguide is revised v. Drug is a REMS drug
Recall on Compounded Drugs --> what steps are taken and what timeline? (5)
1. Contact BOP within 12 hours of recall. 2. Contact recipient pharmacy (if applicable) 3. Contact prescriber (if dispensed to the prescriber; then prescriber will notify patient) 4. Contact patient (if dispensed directly to patient) 5. If any adverse effect, report to MedWatch (FDA) within 72 hours.
Recall on Compounded Drug. 1. What happens in 12 hours? 2 What happens in 72 hours?
1. Contact BOP, patient, physician, pharmacy (as applicable) 2. Contact MedWatch
1. Where can dextromethorphan be found (Brands (2))? 2. schedule 3. sales?
1. Cough syrups (Delsem, Robitussin) 2. not - OTC 3. must be 18+yo - req's ID
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
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
Patient Package Insert 1. Approved by? 2. When to provide to patients (outpatient) 3. When to provide to patients (inpatient) 4. If not provided per (2) and (3) 5. why provide?
1. FDA 2. All estrogen-containing drugs (new AND refills) 3. All estrogen-containing drugs (before admin of first dose and Q30 days) 4. Considered misbranding. 5. VTE risk
Explain how to order controlled substances with Form 222
1. Form 222 is filled out with typewriter, ink pen or non-erasable pencil. 2. Write each item on one line, max 10 items 3. Fill out the name and address of the supplier 4. NDC entry can be blank 5. Enter finalized drug count on the last line number 6. Sign and date form 222 by person of authority (those who signed a document receiving authority) 7. If a mistake is made, must write VOID and restart 8. Each line item must contain: i. Drug name ii. Strength iii. Quantity iv. Size v. Signed with date 9. The supplier records the furnished items and provides any deficient drugs within 60 DAYS from the date of the form 10. Shipment is sent to the DEA listed address 11. Order is checked by the pharmacist and they record the number of packages and date received on copy 3 12. Keep copy 3 AND all scheduled forms for at least 3 years
Required consultation points
1. How to use 2. Compliance with the directions 3. Storage 4. Common adverse events/drug interactions
Exemption for fax CII (able to treat fax as original)
1. If drug is to be compounded for direct admin to patient by parenteral, IV, IM, SC, intraspinal 2. If for residents of long term care facilities transmit rx to the dispensing pharmacy 3. If patient enrolled in hospice program certified by medicare
Theft or loss of CS 1. Notify DEA when? 2. If employee theft, notify BOP when? 3. if non-employee theft/loss, notify BOP when?
1. Immediately (within 1 business day) - form 106. 2. 14 days 3. 30 days.
Pyxis 1. locations? 2. Who can remove meds? 3. Inventory? 4. Info needed on unit doses? (4)
1. In hospital 2. Nurses - log in, remove med needed 3. RPh will check what is in the computer vs drawer QD 4. Name of drug, strength, dosage form mfg, mfg lot number exp date
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
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
What do you report to: 1. ISMP 2. MedWatch
1. Med Errors 2. Adverse events
Naloxone dispensing requirements
1. Must consult! You CANNOT waive this like other Rx's 2. Provide a copy of the current naloxone fact sheet approved by the BOP
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
Natruopathic doctors (ND) 1. Need what to prescribe meds 2. What can they prescribe independently? (3) 3. What can they prescribe under physical protocol?
1. Must use "furnishing number" to prescribe: "NDF" beginning of their license number 2. non-controls, epinephrine, synthetic hormones 3. C3-C5 - including testosterone! *No C2 prescribing*
Consumer Medication Information 1. Approved by? 2. When to provide to patients
1. NOT approved/reviewed by FDA 2. Can provide useful info to pts with each *new* prescription
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
DEA Forms 1. Form 224 1a. Form 224a 2. Form 223 3. Form 225 4. Form 363 5. Form 222 6. Form 106 7. Form 41
1. New application for: retail, hospital, clinic, practitioners 1a. Renewal application for pharmacy (renewed Q3yr) 2. When pharmacy is approved for DEA registration, this form will be issued to the pharmacy. 3. registration for: mfg, distributor, researchers, analytical laboratories, exporters 4. registration for narcotics treatment program 5. Ordering/tranferring C1-C2 drugs 6. Reporting theft or loss of CS 7. Record of CS destroyed
*Medication error* occurs. What Steps are taken? (5) 6. Who to NOT contact?
1. Notify patient. 2. Notify prescriber. 3. Start QA process within 48 hours (keep record x 1 yr) 4. Report to ISMP. 5. If in the hospital, report to P&T Committee. 6. BOP
If patient is harmed by outsourcing compounded drug, who to notify and when? 1. Pharmacy is notified (3) 2. Outsourcing facility is notified (2)
1. Notify physician Pharmacy report to *FDA MedWatch within 72 hours* Pharma report to *BOP in 12 hours* 2. Outsourcing facility report to *FDA MedWatch in 15 calendar days* *BOP in 12 hours*
Emergency Contraceptive (a) location in pharmacy (b) age restriction to buy (c) when to take 1. Plan B - One Step (levonorgestrel) 1.5mg tab 2. 2-tab levonorgestrel 3. Ella (ulipristal)
1. OTC isle, no age limit, take within 72 hours of unprotected sex 2. Behind pharmacy counter, 17+, take within 72 hours of unprotected sex 3. Rx only, no age limit, take within 120 hours (5 days) of unprotected sex
Methadone - where dispensed? 1. For opiate treatment? 2. For pain? 3. Schedule?
1. Only through an opioid treatment program. NOT through pharmacy. 2. pharmacy 3. C2
Automated drug delivery system (ADDS) in nursing facility: 1. What must be in place to have this? 2. Who is in charge of it? 3. Who inventories, restocks, cleans, maintains, monthly inspects? 4. Consultation? 5. Emergency supply?
1. P&P to ensure patient safety 2. RPh, but does not have to be onsite. 3. RPh only 4. not required, but if done, can do via telecommuniation 5. Can be removed, up to a 72H supply
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*
Additional Steps for Protocols: 1. Administering immunizations 2. Self-administered Hormonal Contraceptives 3. Naloxone 4. NRT 5. Travel meds
1. Provide Facts sheet, add to patient profile, notify physician and CAIR with 14 days. 2. Provide Facts sheet, add to patient profile, notify physician with 14 days. 3. Mandatory consult, provide Facts sheet, add to patient profile, notify physician with 14 days. 4. Provide Facts sheet, add to patient profile, notify physician with 14 days. 5. Provide Facts sheet, add to patient profile, notify physician with 14 days.
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
Temperatures (C, F) 1. Controlled RT 2. Refrigerated temp 3. Freezer temp 4. Vaccines: Varicella, MMRV, Zoster 4. Dry place
1. RT: 20-25C (68-77F) 2. Refrigerate: 2-8C (36-46F) 3. Freezer: -25C to -10C (-13F to 14F) 4. Freezer: -50C to -15C (-58F to 5F) 4. Humidity <40%
Adverse Drug Reaction occurs with a compound made by a compound pharmacy what steps are taken and timeline? (2)
1. Report adverse events/recalls to BOP within 12H 2. Notify FDA (MedWatch) within 72 hours
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
buprenorphine/naloxone 1. brands (3) 2. Schedule 3. Where dispensed?
1. Suboxone, Bunavil, Zubsolv 2. C3 3. pharmacy
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
1. 503A 2. 503B 3. To be a registered 503B facility:
1. Traditional compounding (make a product *after* receiving rx) 2. aka, outsourcing facility. Prepares compounded meds in bulk without a rx written for an individual pt. 3. MUST compound sterile drugs for humans.
The resale of drugs acquired at preferentially low prices is prohibited EXCEPT
1. When sold to a walk-in customer w/RX & those sales represent < 1% of the purchasing pharmacy's annual purchases 2. Emergency situation where no other sources are readily available in the community ***For profit must return exact drug & exact amount to non-profit pharmacy when drug comes in.
Oral Rx 1. C3-C5 2. C2 (2)
1. Yes 2. No, unless a) emergency - can fill enough to tide patient over until valid rx can be received. OR b) Pt is a resident of LSNF, intermediate care, home health agency, hospice.
Faxed Rx 1. C3-C5 2. C2 (2)
1. Yes, prescriber's signature and date has to be on original 2. No, except: -prescriber can fax over to give heads up, but pt needs to bring in original before dispensing -terminally ill
What is methadone 40mg used for? What is methadone 2.5-10mg used for?
1. addiction treatment 2. pain
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
DEA is notified within xxx time frame for: 1. Loss of CS
1. immediately (or 1 business day) *loss/theft/anything
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*
ADDS in Emergency Medical Service (EMSADDS) 1. Emergency medical service provider must have... 2. Who can restock? (3)
1. license from BOP to operate EMSADDS 2. Medical director, RPh, or licensed designated paramedic.
Cytotec 1. generic 2. SE
1. misoprostol 2. Diarrhea
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
Drugs *compounded* into unit dose containers that are too small for full label compliance, can have: (4)
1. name of active ingredients 2. Concentration of strength/vol/wt 3. Pharmacy reference lot number 4. exp date
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*
REMS Programs 1. clozapine (Clozaril - antipsychotic) 2. ER/LA opioids 3. Saxenda (liraglutide, 1x injection for wt loss) 4. Addyi (flibanserin) - low libido in women 5. Xyrem (sodium oxybate)
1. neutropenia, monitor ANC; ANC >1500 before starting. (also, BBW: seizures, myocarditis) 2. high abuse potential, life-threatening respiratory depression. Med guide reqd, prescriber must complete approved CE, counsel pts 3. risk of medullary thyroid cancer, pancreatitis 4. risk of HOTN and syncope if used with alcohol 5. Date-rape drug. C3: narcolepsy. C1: any other use. Must be registered for this med.
Number of refills allowed. 1. Non-controlled 2. C5 3. C3-C4 4. C2
1. no limit, can dispense up to 1 year from issue date 2. No limit of number of refills, up to 6 months from issue date 3. 5 refills in 6 months and all refills combined cannot exceed 4 months (120 day supply). Original fill is NOT a refill, not induced in the 120 day supply. 4. NO refills allowed. No emergency refills allowed. Can have emergency verbal order obtained from MD - written order must be sent within 7 days.
RPH can supervise (community setting): 1. # techs at one time 2. # pharmacy interns at one time 3. # pharmacies (if PIC) 4. # pharmacy tech trainee, and for how many hours? 5. # clerks 6. # techs in hospital
1. one, 2 for 2nd RPh 2. two 3. two (within 50 miles of each other) 4. one, 120 hours 5. unlimited 2. 2 per RPh
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
Faxed Prescriptions (p. 24)
1. received ONLY from *prescriber's office* - not from pt's home 2. Reduced to a "hard copy"
How to dispose of meds at home? 1. chemo 2. opioids (including patches) 3. Diastat
1. return to the clinic that dispensed it 2. All down toilet! 3. toilet
naloxone (Narcan) 1. MOA, use 2. onset/duratin naltrexone 3. use 4. onset/duration
1. reversed opioid OD (typically from heroin) 2. onset within mins, lasts 1 hour. 3. Used to block cravings for opioids and alcohol. Cannot treat OD! 4. longer onset, longer duration (1/2 day)
Ex of REMS 1. Thalidomide 2. isotentinoin 3. clozapine 4. Qsymia 5. Avinza, Butrans, Hysingla ER, Kadian... 6. Sexenda 7. Addyi
1. risk of severe birth defects 2. risk of severe birth defects - iPledge program 3. Clozaril - neutropenia 4. phentermine/topiramate - wt loss - birth defects 5. high risk abuse potential, CN depression 6. lirgluatide (Trajenta, anti-DM GLP-1) - medullary thyroid carcinoma 7. finbanserin - female sexual health - HOTN/syncopy with alcohol
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
1. Orange Book 2. *A*B = 3. *B*B =
1. substitution generic for brand and vice versa 2. generic *is* therapeutically equiv to brand 3. generic *is not* therapeutically equiv to brand
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
max # of items on DEA 222 form
10! this is why using the CSOS is good; no limit on it
Which DEA form is used for significant theft and loss of controlled substances?
106
What font is Rx printed?
10pt . 12 pt upon request
How many refills can be given for non controlled PRN refills?
11 refills (not including the original fill), up to 1 year (standard prescription expiration date)
Exemption code of controlled rx
11159.2 Exemption. For CII-CV.
How many non-spermicidal condoms can pharmacists provide to each Medi-Cal client
12
How long do you to notify the BOP for a recall?
12 hours
How long does a satellite pharmacy have to report adverse effect or recall?
12 hours
Must report AEs to BOP within...
12 hours
Non-resident pharmacy has how long to report recall to any recipient or provider
12 hours
drug recalls: pharmacy must notify recipient and board within?
12 hours
How soon must a pharmacy contact the recipient pharmacy, prescriber, patient of the recalled and the board about a recall notice of s sterile compounded drug?
12 hours *All parties must be notifed if drug is dispensed (prescriber, patient and pharmacy recipient)
What is maximum supply allowed for contraception
12 months
How often proficiency exam for tech?
12 months. Records kept 3 years.
What font size is required on labels?
12 point for name of patient, med name/strength, med directions
Normal RR
12-20 breaths per minutes
If unable to get a new PIC with 30 days of original PIC leaving, the board can provide an extension. How long is this extensinon?
120 days
Maximum day supple of C3-C4?
120 days (C5 exception) within 6 months
What are requirements for office use compounding for vets?
120 hours supply
Allegra-D 12hr has how many mg of pseudophed?
120 mg. 3 boxes in a day of #10.
Must report to the California Board of Pharmacy of any loss/theft
14 days
Pharmacy to report to CABOP of losses due to theft, self-use, or diversion by a board licensee.
14 days
Within how long should the PIC report to BoP if a theft is identified to be done by a pharmacy technician?
14 days
Within how many days must the SBoP be notified of any *admission* by a *licensed* individual of theft, diversion, or self-‐use of dangerous drugs?
14 days
Within how many days must the SBoP be notified of any admission by a *licensed* individual of chemical, mental, or physical *impairment* affecting his or her ability to practice?
14 days
Within how many days must the board be notified by the PIC if a licensed employee of the pharmacy is found chemically/mentally/physically impaired
14 days
Within what time frame should the PIC report to the board if she finds that one of the pharmacy technicians stole a significant amount of Norco tablets?
14 days
time you have to report to the board tampering with a med take-back bin
14 days
time you have to report to the board theft of deposited drugs in the med take back bin
14 days
Within how many days must the CABOP be notified of any *termination of a licensed* individual based on theft, diversion, or self-‐use of dangerous drugs?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any *termination* based on chemical, mental, or physical impairment of a *licensed* individual to the extent it affects his or her ability to practice?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any video or documentary evidence demonstrating chemical, mental, or physical impairment of a *licensed* individual to the extent it affects his or her *ability* to practice?
14 days (B&PC § 4104[c])
Within how many days must the CABOP be notified of any video or documentary evidence demonstrating theft, diversion, or self-‐use of dangerous drugs by a *licensed* individual?
14 days (B&PC § 4104[c])
How long do you have to notify the physician and CA Immunization Registry after an immunization?
14 days for both
How long does a pharmacy have to notify BOP of any theft or impairment
14 days of theft. DEA immediately if it is a controlled substance.
AQUEOUS ORAL formulation BUD
14 days stored at controlled cold temperature (</= 8 C)
If no security prescription for Schedule II drug is sent by prescriber to the pharmacy following an emergency oral prescription, what is the time period the pharmacy must notify the DEA?
144 hours
if the original rx is not received (for emergency dispensing), the pharmacist must report to the california bureau of narcotic enforcement within?
144 hours
if no security rxs for schedule 2 drug is sent by prescriber pursuant to emergency oral order - time period for pharmacist to notify dea
144 hours after 7 days of emergency oral order
What age do you need to buy hypodermic needles
18 or older
How old to buy pseudophed?
18 yo
Requirements for pharmacy license
18 yo, graduated college of pharmacy or dept of pharmacy of a university. If foreign then certified by FPGEC. Completed 150 units of collegiate study in the US or equivalent in foreign country. No less than 90 units must have been a resident of US. Complete 1500 hours of pharmacy practice. Passed written & practical exam given by board. Proof of qualifications supplie to board. Paid fees
Normal BMI
18.5 - 24.9
Temporary permit issued upon transfer of ownership
180 days
What is the maximum beyond-use-date (BUD) for any compounded prescription?
180 days
Pharmacist to tech trainee ratio
1:1
Pharmacist to technician trainee ratio
1:1 for only 120 hours
Technician : pharmacist ratio at a retail pharmacy
1:1 for the first pharmacist; after 1st pharmacist, 2:1
What training is required for travel meds furnishing?
2 CE hours
Requirements for furnishing nicotine
2 CEs every 2 years
How many interns can a pharmacist supervise?
2 Max in both OP and IP
How many interns can a pharmacist supervise?
2 at a time
How quickly must the supplier report a controlled substance purchase to the DEA after receiving an order?
2 business days
Investigation of medication errors must begin within ___
2 business days
Produce records stored off-site within...
2 business days
Within what time frame should pharmacy provide offsite Rx records upon request?
2 business days
How many pharmacies can a PIC supervise up to and with what criteria?
2 pharmacies within 50 driving miles
How many pharmacies can a PIC supervise at the same time?
2 pharmacies; within 50 driving miles
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
All board of pharmacy licensees are mandatory to report abuse or neglect within ___
2 working days or 36 hours
When to send a written report of child/elder abuse/neglect incident?
2 working days or 36 hours to law enforcement.
After approved waiver, how long do CS rx records need to be stored in the pharmacy before moving off-site?
2 years
Controlled records can be MOVED to off-site storage after
2 years
How long do controlled records need to be kept on site?
2 years
How long to keep records? Pseudoephedrine, ephedrine, etc logs
2 years
Pseudoephedrine, ephedrine, pheynlpropanolamine, norpseudoephedrine sale logs
2 years
Sale log of >60mg pseudoephedrine should be kept for how long?
2 years
When can Controlled records be moved off-site?
2 years
controlled substance Rx need to be kept in the pharmacy for how long?
2 years
how long to keep psuedoephedrine logs
2 years
pseudoephedrine, ephedrine, phenylpropanolamine, and norpseudoephedrine sale logs keep for atleast?
2 years
How long are pseudophed records kepts?
2 years - check
PIC self-assessment every __ years
2 years, or within 30 days if new permit/PIC/location
Controlled substance Rx need to be kept AT THE PHARMACY for how long?
2 years; afterwards can be kept offsite for 1 year
How full does a sharps container have to be before you return it?
2/3 full
APh requirements
2/3: - certification in relevant area of practice i.e. amb care, critical care, oncology, pharmacotherapy - post-grad residency program - provided clinical services for ONE year at least 1500 hours under CPA
Which DEA form is used for hospital pharmacy registration?
224
Which DEA form is used for physician registration?
224
Which DEA form is used for retail pharmacy registration?
224
All actions related to ordering tests, interpretation and management must be documented w/in:
24 hours
Amount of time that all actions related to test ordering, interpretation, and management must be documented by
24 hours
drug recalls: outsourcing facility must notify recipient and board within?
24 hours
Test ordering and interpretation must be documented within.. and include what...
24 hours - interpretation of result - rationale for decision - information provided to the patient and healthcare team members
Blood clotting agents 1. Notifies patient of Class 1 or Class 2 recall of blood clotting agents/ancillary infusion equipment within....
24 hours of receiving notice
Irregularities during drug supply inspection reported within...
24 hr to PIC or CEO
Claritin-D 24hr have how much pseudophed
240 mg
How long are multi-dose vials good for?
28 days after you puncture it Exception: Epogen only for 21 days
Multi-dose vials must be discarded after ____ days after first use.
28 days. Exception: Epogen multi-dose vial must be discarded after 21 days.
How soon to notify BOP that mobile pharmacy is over and restoration of permanent pharmacy is open?
3 calendar days.
How long after restarting a permanent pharmacy after a state of emergency do you have to notify the board of pharmacy?
3 days
physical inventory of C2 is performed every?
3 months
request Waiver from BofP to store records offsite
3 requirements: records are secure, remain confidential, if an inspector comes to the pharmacy they can request the records and you need to supply the records w/in 48 hours (2 business days)
How long do you hold an Epi-Pen for?
3 seconds
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
ALL drug acquisition or disposition must be maintained for
3 years
Amount of time copy 3 of DEA form 222 must be kept
3 years
How long are prescription records kept in the pharmacy?
3 years
How long are records kept for laminar flow hood certifications?
3 years
How long are self-assessments kept for?
3 years
How long do all rx records need to be kept?
3 years
How long do prescriptions have to be stored for?
3 years
How long do you have to keep DEA 222 forms?
3 years
How long should DEA-222 be kept for?
3 years
How long should controlled substance inventory record be kept?
3 years
How long should records for dispensing epipen to schools be maintained for
3 years
How long should records of dangerous drugs/devices to approved emergency service providers be maintained for
3 years
How long to keep DEA 22 forms?
3 years
How long to keep DEA 222?
3 years
How long to keep prescriptions?
3 years
How long to keep records for sterile compounds?
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 the pharmacy self assessment forms?
3 years
How many years should non-controlled substance chart orders be kept?
3 years
How often should the self-assessment forms be kept at the pharmacy?
3 years
If RPh doesn't renew their license, after how long are they unable to pay a fine and renew (reqd to re-take licensing exams to re-instate license)?
3 years
If a pharmacy discontinues Business (Bankruptcy), all prescription records, electronic files (patient profiles, invoices and prescriptions), a current inventory of dangerous drugs and devices, and acquisition and disposition records must be maintained in a board-licensed facility for at least ______ years.
3 years
PIC self-assessment form kept for __ years
3 years
Purchase invoice for all RX drugs
3 years
Purchase invoices for all Rx drugs
3 years
Record documenting return of drugs to wholesaler or manufacturer
3 years
Record documenting transfer or sales to other pharmacies, Licencees and Prescribers theft and loss report (DEA Form 106
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 (completed by July 1st of every odd year)
3 years
Sterile compounds from non-sterile ingredients: have to keep records for at least _____ years.
3 years
Theft and loss reports of controlled substances (DEA Form 106)
3 years
U.S. Official Order Form (DEA 222), Power of Attorney for completion of DEA 222
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 biennial controlled substance inventory forms
3 years
how long to keep clinic pharmacy rx records
3 years
how long to keep community pharmacy rx records
3 years
how long to keep controlled substance inventory records
3 years
how long to keep controlled substances inventory records
3 years
how long to keep dea 106 forms
3 years
how long to keep dea 222 forms or power of attorney forms
3 years
how long to keep dea form 222 order records
3 years
how long to keep hospital rxs for non controls
3 years
how long to keep pharmacy tech compliance records
3 years
how long to keep prescriptions
3 years
how long to keep purchase invoices for all prescription drugs
3 years
how long to keep records documenting the return of drugs to a wholesaler
3 years
how long to keep records of furnishing NRT
3 years
how long to keep records of furnishing contraception
3 years
how long to keep records of furnishing naloxone
3 years
how long to keep self assessment of pharmacy record (both sterile and non-sterile compounding)
3 years
how long to keep self-assessment forms
3 years
how long you have to keep clinic or pharmacy rxs
3 years
time to keep each self-assessment form in the pharmacy
3 years
Biennial Self-Assessment of Pharmacy Records
3 years completed by July 1st of each odd year
How long should a pharmacy keep records of prescriptions?
3 years including electronic records.
Minimum age for an immunization by pharmacis
3 years old
DEA 222 records are kept in CA?
3 years. Fed says 2 years
How long should DEA form 222 order records be kept
3 yrs - California
How long should controlled substance inventory records be kept
3 yrs from taking of inventory
How long should pharmacy technician compliance records be kept
3 yrs from time of making
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
psuedoephedrine limits
3.6 g in 1 day 9 g in 1 month (unless mail order then 7.5 g) 3 packages per transaction (Exception is the single dose 60 mg packages - dont need to log these) have to show ID w/ photo
Daily max of pseudophed?
3.6 grams. Monthly 9 grams. Mail order 7.5 g in 30 day period
How many CE hours do you need to keep license current?
30 CE hours every 2 years
AQUEOUS TOPICAL formulations
30 days
Change of PIC reported to board within __ days
30 days
How long do you have to appeal a citation?
30 days
How long do you have to report a change in PIC?
30 days
How many days does pharmacy have to inform board that it will furnish meds to a master/first officer of a vessel
30 days
If a partial fill is requested by the patient or provider that wrote the rx of a C2, the remaining portion of the prescription must be filled within what time frame?
30 days
If a pharmacist changes his/her e-mail address, within how many days should he/she notify the board of this change?
30 days
Non-scheduled drug loss, notify bof pharmacy w/in ________ days
30 days
Pharmacy change in PIC. When should the board be notified?
30 days
Reporting Time Period? Change of pharmacist address or name
30 days
Reporting Time Period? Change of pharmacist-in-charge
30 days
Within how many days must the board be notified of a change of pharmacy ownership, pharmacy permit, change in address or name, change in PIC.
30 days
Within how many days must the board be notified of a change of the pharmacist-in-charge
30 days
Within how many days must the board be notified regarding any change in pharmacy permit
30 days
change in name/address, or PIC, notify bof pharmacy w/in ________ days
30 days
change of PIC must inform board within ___ days
30 days
how many days must the board be notified of a change in the pharmacist in charge
30 days
how many days must the board be told of change of address or name
30 days
how many days to tell board of change in pharmacy ownership
30 days
When a pharmacy contracts to compound a drug for parenteral therapy, the contractual arrangement is reported to the board within how many days of commencing compounding?
30 days (B&PC § 4123)
Within how many days must the board be notified of drug loss (by destruction or pilferage)
30 days (if controlled substance DEA notified immediately)
What are the two different days to report a controlled substance loss to the BOP?
30 days for loss 14 days for theft
amount of CE hours needed per 2 years and time to keep the certifications of completions
30 hours and 4 years
How much continuing education (CE) is required?
30 hours every 2 years
Continued Education Hour Requirement
30 hours for each 2 year license renewal period
Continuing Education Hour Requirement
30 hours for each 2 yr license renewal period Pharmacy graduates are exempt from CE's for 2 years after they get licensed. They are considered up to date.
How many CEs should be performed within a pharmacist's active license period?
30 hours of CE within 2 years. The first 2 years are exempt and the license expires the last day of the pharmacist's birth month. The certificate of completion of the CE must be kept for 4 years.
CE requirements
30 hr every 2 years *first 2 years - exempt
Continued education requirement and who's exempt
30 hrs during each 2-year license period, but first 2 year license cycle is EXEMPT from CE requirement
CE requirement
30 hrs for each 2 year licensure renewal period
What must an RPh complete every 2 years?
30 hrs of CE, license renewal
How long are pharmacist breaks or meal periods?
30 min
What is the maximum amount of time a pharmacist may leave the pharmacy with other non‐pharmacist personnel present?
30 minutes
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
How long are CEs good for?
4 years
How long do CE certificate of completion must be kept?
4 years
How long to keep records? Certificate of completion for continuing education
4 years
how long to keep CE certificates
4 years
how long to keep certificates of CE course completion
4 years
how long you have to keep your CE education forms for
4 years
record: certificate of completion for continuing education?
4 years
What is the service term of the BOP board members?
4 years and can be re-elected once
How long should certificates of CE course completion be kept
4 yrs from date of course completion
Which DEA form is used for destroy of C-II drugs?
41
SC injection angle and IM injection angle
45 and 90
If a prescription is located off-site, how long does the pharmacy have to retrieve the record if asked by the CBOP?
48 HOURS
Amount of time a prescriber has to sign an order put in by the nurse
48 hours
Mobile pharmacy services during a State of Emergency - services must be stopped within ____ of emergency being terminated.
48 hours
Records must be retrieved from off-site storage upon request within...
48 hours
Verbal orders must be countersigned within what time period?
48 hours
period of time PIC must do investigation and report once med error is discovered
48 hours
If not physically present at the time of prescribing, a prescriber has what time frame to countersign the order of an inpatient in the chart or medical record within a hospital?
48 hours (CCR § 70263[g])
How long does a hospital prescriber have to sign an order?
48 hours after being submitted
If mobile pharmacy is started after main pharmacy is destroyed/damaged, when must the mobile pharmacy halt business after original pharmacy is restored
48 hours after restoration
How soon must pharmacy provide records from off-site storage?
48 hrs
If records are off-site, how soon to pull it for patient?
48 hrs
Refill limits for C-III and C-IV drugs?
5 refills within 6 months
max refills for CIII and CIV
5 refills within 6 months all refills combined cannot exceed a 120-day supply (not including first fill)
Schedule III and IV controlled substance prescriptions refill maximum
5 refills within 6 months and all refills cannot exceed *120* day supply
What is the limit on prescription refills for schedule III and IV controlled substances?
5 refills within 6 months and all refills combined NTE 120 day supply (aka 5 months, original fill not included in count) *Schedule V have unlimited refills
Maximum refills of C3-C5?
5 times valid for 6 months of written date
Sale of CS to other pharmacies/prescribers cannot exceed ___% of total number of CS dosage units dispensed per calendar year.
5% -otherwise will need to obtain wholesaler registration from DEA and BOP.
What expiration date should be on the Rx label for the drug dispensing on 5/31/2016, if the manufacturer's expiration date is 6/2018?
5/31/2017 or 6/2018
distance between the max 2 pharmacies a PIC can supervise
50 driving miles
What percent of the label should name of patient, med name/strength, med directions take up?
50%
Format of prescription label on containers must include 4 CRITICAL ITEMS
50% of label 12 point sans serif typeface In the following order: - name of patient - name of drug, brand name equivalent if generic, manufacturer if equivalent, and strength - directions for use - condition if on Rx
Patient acknowledgement of HIPAA must be kept for...
6 YEARS
How long is a temporary permit for transfer of pharmacy ownership?
6 mo max (180 days)
time period a schedule 3, 4, or 5 rx must be filled or refilled before it is void
6 mo or less (unless drug expires before 6 mo)
A hood must be certified every ____ months.
6 months
Amount of time all controlled substance prescriptions are valid for
6 months
Controlled Substance Prescriptions Valid for How Long?
6 months
Temp permit for transfer of ownership
6 months
Within how many days must a valid prescription for a controlled substance drug be filled?
6 months
number of days in which a rx for schedule 2 must be filled
6 months
How long as CII rx are valid?
6 months (all controlled)
Expiration date for CII?
6 months from date physician wrote it (exception terminally ill - 60 days from writ)
How long are C-II drug Rx be valid for?
6 months from issue date
How long are C-III , C-IV, C-V drug Rx be valid for?
6 months from issue date
Compounded NON-AQUEOUS RX BUD
6 months or less
Compounded Rx expiration date?
6 months or less
Expiration data for any compounded prescription
6 months or less (if any ingredient expires before 6 mo)
Compound product exp date
6 months or shortest expiration of any ingredients
Expiration date of compounds?
6 months unless ingredient expiration date is sooner
How long is controlled Rx good for?
6 months.
3Ts have to be kept for?
6 years
HIPAA
6 years
How long do pharmacy keep privacy notices on file?
6 years
How long do pharmacy need to get their HIPAA privacy notices on file?
6 years
How long must you keep transaction information of drugs?
6 years
How long to keep records? Patient acknowledgment of HIPAA
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
time you have to keep pt acknowledgement of HIPAA
6 years
Which of the following can prescribe schedule III-V drugs under protocol? 1. Physician 2. Podiatrist 3. Veterinarian 4. Dentist 5. Optometrist 6. Naturopathic doctors 7. Nurse practitioner/physician assistant/certified midwife 8. Pharmacists
6, 7, 8 (5-optometrist who can prescribe will have T at the end of license number; can prescribe condeine- and hydrocodone- containing drugs for maximum 3 days)
A partial fill of a C2 drug is allowed for a LTCF resident --> the remaining portion of the prescription must be filled within what time frame?
60 days
Any other licenses issued by the Board may be canceled by the Board if the license is not renewed within ____ after its expiration.
60 days
number of days which a rx for schedule 2 mus be filled if for terminally ill pt in a SNF and time limit for filling total RX if it is partially filled
60 days
A partial fill of a C2 drug is allowed for a terminally ill patient --> the remaining portion of the prescription must be filled within what time frame?
60 days - must note "11159.2 exemption - terminally ill" on rx
Within how many days of obtaining a license must a pharmacist join the board's email notification list?
60 days from license renewal
Mucinex-D 12hr - how much pseudophed?
60 mg
Compounded non-aqueous Rx BUD
6mo (180 days) max
How long does a prescriber have to send the Schedule II security prescription to the pharmacy following an emergency oral prescription?
7 days
How long to keep records? Hospital pharmacy chart order of controlled drugs
7 year
Copy of controlled Rx held for __ years in hospital
7 years
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 do you have to keep hospital pharmacy RX records?
7 years
How long must hospital controlled prescriptions be kept?
7 years
How long to keep hospital Rx records?
7 years
How many years should controlled substance chart orders be kept?
7 years
chart orders are controlled substances are kept for?
7 years
how long to keep hospital Rx records
7 years
record: hospital pharmacy chart oder records for controlled substances keep for atleast?
7 years
time you need to keep hospital pharmacy orders for controls
7 years
Which of the following can prescribe schedule II drugs under protocol? 1. Physician 2. Podiatrist 3. Veterinarian 4. Dentist 5. Optometrist 6. Naturopathic doctors 7. Nurse practitioner/physician assistant/certified midwife 8. Pharmacists
7, 8
What is the PSE limit for mail order?
7.5g per 30 days (not 9g like retail)
What expiration date should be on the Rx label for the drug dispensing on 5/31/2016, if the manufacturer's expiration date is 7/2016?
7/2016
How long do you have to report an adverse effect to MedWatch?
72 hours
If a non-controlled pad CII for a terminally ill patient doesn't have the exemption code written, how long does the prescriber have to send it back after a fill?
72 hours
if md forgets 11159.2 on regular rx pad for a control, how long does he have to correct it
72 hours If the blank does not have 11159.2, the pharmacist can still fill it if they know the patient is terminally ill. It still must be reported to CURES
What are requirements for office use compounding with humans?
72 hours supply max "reasonable quantity"
If unable to supply the full quantity, a pharmacist may partially fills a Schedule II prescription and the remaining portion of the prescription must be filled within what time frame?
72 hours(21 CFR § 1306.13[a])
If a patient is harmed by the compounded drug preparation, the pharmacy and outsourcing facility should report to the FDA Medwatch within ____ and ____, respectively
72 hours; 15 calendar days
What is the distance requirement for centralized hospital packaging pharmacy?
75 miles Must have barcodes
Nonsterile preparation--USP___?
795
Sterile preparation--USP___?
797
Hazardous drugs in healthcare setting--USP___?
800
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
Maximum days supply of CII
90 days
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
Submit data to CAIR (CA Immunization Registry) after administration of vax
<14 days
What is a remote dispensing site pharmacy and who can sign for orders?
<225 Rx daily over a year No pharmacies within 10 miles Technician can sign IF IT'S AN ORDER FOR CONTROLLED, it needs to be kept in a separate location and verified by an Rph
What is the RX limit for remote dispensing site pharmacy?
<225 prescriptions
How long do you have to retrieve off site records?
<48 hours
What is the maximum number of dose/packages of pseudoephedrine that can be sold at a single transaction in California?
<= 60mg/3 packages
What is the threshold for not needed to pre-print presribers?
>25 prescribers can write info in Exception: CII must always have prescriber printed
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
Can an emergency supply be given to a patient if it is CIII-V presription?
A prescription for a controlled substance, except in CII, may be refilled without prescriber's authorization if the prescriber is unavailable and if in RPh's professional judgement, failure to refill the rx might present an immediate hazard to the patient's health and welfare or might result in intense suffering. - Refills are limited to a reasonable amount to maintain therapy until the prescriber can be reached. The RPh also must inform the patient that the prescription was refilled without prescriber's approval.
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*
What setting can you have tech-check-tech
ACUTE CARE hospitals only
A prescribers signature and date must be written in his own handwriting for...
ALL CS! C5-C2
Security prescription form
All orders for controlled substance including CV must be ordered by MD on this form. If C3-5 are on a non-security form, treat like oral or fax, verify with MD and write on pharmacy pads.
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)
When does a non-controlled Rx be written on a security pad?
All written Medicaid or Medical OP Rx must be written on special tamper-resistant Rx blanks
Dispensing epi injectors
Allowed for certified persons - pre-hospital emergency person - lay rescuer - authorized entity
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
What is MEDMARx?
Allows hospitals to report anonymously. This is through ISMP.
Drug Addiction Treatment Act (DATA) -
Allows physicians to treat opioid addiction with CIII-CV drugs including buprenorphine. UIN and DEA # need to be on Rx
503B: outsourcing facility is allowed to do what...
Allows specially licensed compounding facilities to prepare meds in BULK and WITHOUT a prescription written for an individual patient Important during drug shortages
Traditional compounding includes...
Altering dosage form or delivery system Altering strength Combining ingredients Preparing from bulk
Types of traditional compounding
Altering the dosage form or delivery system Altering the strength Combining components or active ingredients Preparing a drug product from chemicals or bulk drug substances
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
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)
How many times may a nonscheduled RX be transferred to different pharmacies?
As many times as there are refills
QA records, pt profile, pt medication error records? How long to keep.
At least 1 year
Quality assurance Records
At least 1 year
How long do you need to keep a patient profile on record?
At least 1 year after the last entry
How long should the patient medication record be kept?
At least 1 year from the date the last prescription was filled
How long do you have to report to DEA prior to closing a pharmacy for good?
At least 14 days BEFORE closing
Community/Clinic Pharmacy Rx Records
At least 3 years
How long should community pharmacy prescription records be kept
At least 3 years after last filling of prescription
How long should community/clinic pharmacy prescription records be kept
At least 3 years after last filling of prescription
Hospital Pharmacy Rx Records
At least 7 years
How long should hospital pharmacy prescription records be kept
At least 7 years after last filling of prescription
Review of drugs in an automated drug delivery system must be reviewed atleast ____?
At least Monthly
What are options for disposing controlleds?
Authorized collectors Mail-back programs Take-back programs (DEA)
CANNOT own pharmacy/get license to own if
Authorized to prescribe Shares a community or financial interest in the permit Any corp that is controlled by or a person has > 10% stock (except an inpatient hospital pharmacy that is owned by the hospital that it is located in)
ADDS
Automated Drug Delivery Systems Must be stocked by pharmacist if cabinet stocked in the facility, or by pharmacist/intern/tech if stocked elsewhere and brought back to the pharmacy Must be checked by pharmacist before removal
Which DEA 222 to give to Pharmacy/Recipient?
BLUE
If pharmacy goes bankrupt, how long to keep records?
BOP licensed facility for 3 years.
Counterfeit drug. When to report?
BOP within 3 days.
Regulation status for two-pill levonorgestrel 0.75mg as EC
BTC and Rx
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
Do not refrigerate
Bactrim Lovenox Lasix Avelox Nexium Neosynephrine (phenylephrine) Dilantin Flagyl Ofirmev Precedex Hydralazine (BLLANND FOPH)
May make birth control less effective
Barbiturates Bosentan Rifampin Rifapentine Ampicillin Anticonvulsants Tetracycline St. Johns wort HIV drugs Griseofulvin (BBRRAATS HG)
Centralized hospital packaging products must be...
Barcoded to be machine readable at patient's bedside
When must the pharmacy (PIC) conduct a Self-‐Assessment? (4)
Before *July 1st* every odd-number year or within 30 days of (1) a new permit;(2) change in PIC; (3) change in location
When does PIC fill out pharmacy assessment survey?
Before July 1st of every odd numbered year. 30 days if new PIC. Keep for 3 years.
How often should the self-assessment form be completed?
Biennially (every 2 years)
Controlled DEA Controlled Substances Inventory is completed
Biennially (every 2 years) C2 inventory is separated from C3-5. Separate C2 records are maintained. This includes C2 Rx, invoices, DEA order form 222, and inventory records
How often are controlled substances inventoried?
Biennially (every 2 years) CII - every quarter
How to deal with 60 day of Norco but insurance covers 30 days?
Bill insurance 30 days. Cash out 30 days.
Purple Book
Biological products and bio similar interchangeables (highly similar structure and function and has no sig difference in safety and efficacy to reference drug)
Explain how the triplicate forms work with DEA 222
Blue (Buyer) Green (DEA) Brown (supplier) When the pharmacy receives the shipment, the pharmacy receives the blue copy (copy 3), and sends back copies 1 and 2. The supplier keeps the brown copy (copy 1). The green copy (copy 2) goes to the DEA by the supplier.
Where do you dispose of controlled substances?
Blue bin, unless it's hazardous
Controlled substances go in which waste?
Blue waste unless Chloral hydrate. IV bags must be emptied in blue bin. Must be documented.
Waste for Non-controlled IV bag?
Blue waste. Controlled rx must be emptied
INH
Blurred vision Photosensitivity
List of Rx pads that have been stolen can be found where: (p. 94)
Board of pharmacy's website
When nonschedule & schedule III, IV, & V are lent, borrowed, sold or bought btwn pharmacies, what is the responsibility of the pharmacist & pharmacy
Both pharmacies must keep a log of the transfer whether it is lent, sold, borrowed or bought. CII requires form DEA 222
Covered California sold in four levels of coverage
Bronze, Silver, Gold, Platinum Minimum coverage plan for < 30 years old
Fiorinal
Butalbital 50 mg (controlled), caffeine 40 mg, ASA 325 mg CIII
What controlled substances can ND prescribe?
C III-V (testosterone a C3, needs a protocol). Epinephrine and synthetic hormones independently prescribe.
The statement "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" should appear on the container of which drugs?
C-II, C-III, C-IV
Belbuca schedule and generic
C-III Buprenorphine film
Refill limits
C-III and IV only: - max 5 refills within 6 months - all refills combined cannot exceed 120-day supply
What schedule of drugs can be prescribed under DATA 2000 for opioid addiction treatment?
C-III to C-V (Suboxone, Subutex. Probuphine)
How often do you have to report to CURES for a <48 hour supply?
C-IV --> no reporting required C-II CIII --> monthly Normal: weekly
Can you dispense C2 without refill authorization as an emergency supply?
C2 Can NOT be refilled and cannot have emergency supply without an emergency phoned in Rx from MD (yada, yada 7 days)
how to keep CS records
C2 separately. CIII-V can be separated entirely from both CII & non-controlled OR CIII-V can be incorporated with non-controlled files if marked with a red C
what medictios are required to have the following auxillary label: "CAUTION: Fedearl Law prohibits the transfer of this drug to any person other than the patient for whom it ws prescribed"?
C2-C4
Transfer Rx of CS 3-5
C3-5 can only transfer Rx once unless the pharmacies electronically share a real-time, online database, in which case the Rx is transferred up to the max refills permitted. For Controlled script each pharmacy needs the DEA # of the other pharmacy. VOID is written on the face of Rx for the transferring pharmacy. The name of the pharmacy that the Rx is transferred and all other info is written on back of VOID Rx. For the receiving pharmacy, the Rx is reduced to writing by pharmacist and transfer is written on face of transferred Rx and all other required info as well
Compounding rules: CCR ________
CCR 1735
How to report an error due to the drug NAME?
CDER MedWatch
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*
Apomorphine shedule
CII in California but not a schedule federally
If <48 hr supply of CII-CIV is dispensed, should you still report to cures?
CII-CIII: must report to cures on a monthly basis CIV: not required Any control that is dispensed with > 48 hr supply must be dispensed on a weekly basis
CURES covers what scheduled drugs
CII-CIV
What can a certified NP write for?
CII-CV
Controlled privileges of NP/CNP?
CII-CV. Need own DEA#
Controlled privileges of PA?
CII-CV. Need own DEA#
Controlled privileges of midwife?
CII-CV. Need own DEA#
Certified Nurse-Midwife prescribing drugs
CII-V allowed
PA prescribing drugs
CII-V allowed
When can a prescriber write their info on a prescription for a controlled substance?
CIII-CV
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
Time period a schedule V prescription must be filled or refilled before it is void?
CV must be filled within 6 months. No refill limit.
End of life Option Act requirements
California adult resident Mentally competent <6mo to live
What can a clinic dispense med wise?
Can administer all including CII? Can dispense non-CII's only
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
What are the Schedule V refill rules?
Can be refilled as many times as prescriber wants?
Correcting errors on Rx
Can be revised by pharmacist if minor (misspelling of drug name) or after consultation with MD if significant Pharmacist must document discussion, rewrite as oral Rx and original voided, or MD resend new Rx
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
Federal, state, or local emergency
Can dispense controlled and non-controlled in REASONABLE QUANTITIES Must have record of name, address, drug name/strength/quantity or device Must make effort to communicate to patient's provider
What is the policy for emergency refills?
Can dispense undetermined supply of emergency supply until prescriber is contacted. Must document on the controlled prescription the date, quantity dispensed, prescriber was unavailable and reason to refill the Rx without the prescriber's authorization.
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
internet Rx
Can only dispense Rx after patient has been examined by a Doctor. If violated 25,000 fine per occurance.
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 Clerks
Can request and recieve refill authorization but not new Rx (only pharmacist or pharm intern). No ratio requirement for pharmacy clerk to pharmacist
What auxiliary label is required o all controlled substances?
Caution: federal law prohibits the transfer of this drug to any person other than...
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
How to verify "DNS"?
Check box and MD initials. EXCEPT electronic Rx.
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
What do you have to do to furnish hormonal contraception?
Complete 1 CE hour
Does the HIPAA Privacy Rule protect a minor's right to keep his or her prescription info confidential in respect to a parent's inquiry about the child's medication history?
Confidentiality may dissipate for a minor if the minor is under 15 years of age and the parents are paying for the child's medical care and prescription
What should pharmacist do if MD writes for scheduled medication incorrectly
Contact MD for clarification. Make correction on security RX. Document changes & note that it was authorized by MD. NOT required that MD send new security RX.
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
What form for phentermine?
Controlled Rx form (C-IV)
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
Controlled medications can be moved to an off-site storage after___
Controlled prescriptions must be kept for a total of 3 years, but it can be moved to an off-site *after 2 years* from the last date of dispensing.
General Emergency Refill
Controlled substance EXCEPT CII may be refilled w/o MD authorization if MD unavailable & pharmacist's professional judgment. Refill ONLY reasonable amount to maintain patient until MD available. RECORD on reverse side of RX: date & quantity given, note MD not available, & judgment for dispensing
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
when the pharmacy distributes CS 2 to other DEA registrants
Copy 2 of the DEA form 222, is properly completed by the pharmacy selling the CS and that copy is submitted at the end of each month to the DEA regional office
Hazardous drugs exmaples
Coumadin, nicotine patches, epinephrine (when still unused), phentermine, bulk chemo
What does a Rph have to for a first fill out of an automated system?
Counsel, via telecommunications
Where must a take-back program register and by when?
DEA BOP in writing within 30 days after installing or discontinuing
How long do you have to report a controlled substance THEFT?
DEA - 1 business day BOP - 14 business days
What form should be used to report significant theft of loss of controlled substances?
DEA 106
Which DEA form reports theft of controlled substances?
DEA 106
Requirements for selling a CII to a doctor for office use
DEA 222
What form is used to distribute schedule I drugs between DEA registrants?
DEA 222
What form is used to distribute schedule II drugs between DEA registrants?
DEA 222
Which DEA form is used to order schedule I and II drugs?
DEA 222
must order C2s using this form
DEA 222 or use the controlled substance ordering system (CSOS)
What documentation should pharmacy A use to sell Metadate to pharmacy B?
DEA 222 (C-II)
Which DEA form allows for registration of manufacturers, whole salers, distributers, researchers, analytical laboratories, importers and exporters?
DEA 225
Which DEA form is used to register narcotic treatment programs?
DEA 363
Which DEA form records destruction of controlled substances?
DEA 41
if selling controlled substances to reverse distributor, need to fill out this form
DEA 41
DEA form that pharmacies, hospitals, etc need to fill out to register with the DEA
DEA form 224
DEA form for new application for pharmacy?
DEA form 224 DEA Form 224 is the registration form for retail pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners
DEA registration form for narcotic treatment programs
DEA form 363
Disposal of controls form?
DEA form 41
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*
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
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!!!!!!
What is required in a QA report after a med error?
Date location participants Pertinent data Findings Recommended changes
Physical Assessment (p. 70)
Documentation is *REQUIRED*
MD checks "Do Not Substitute" with no initial on HARD copy. What to do?
Don't fill prescription, call MD to verify
When do you and don't you need a compounding license?
Don't need it for RECONSTITUTING
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
All written C2-C5 drugs need to be written on CA Security Prescription forms. -exceptions (2)
Emergency Use. - Security form needs to be sent/delivered to pharmacy in 7 days. Terminally Ill
When is the only time a pharmacy can get samples to dispensing?
Emergency situations such as drug shortages
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
How often do you have to inventory CIII-V?
Every 2 years
How often to complete? Controlled substances inventory
Every 2 years
How often must a controlled substance inventory be taken?
Every 2 years *Inventory records of schedule II drugs must be separated from other controlled substances
How often do e-prescribing softwares need to be audited?
Every 2 years by a third party
Pharmacist CE (30 hours in 2 yrs)
Every 2 years, *EXCEPT* first cycle
How often to complete? Pharmacist continuing education (30 hours)
Every 2 years, except first cycle
Pharmacist continuing Education (30 hours)
Every 2 years, except first cycle.
Frequency of all controlled substance inventory reconcilliation.
Every 2 years. <1,000 units = estimate >1,000 units = exact count
How often to complete? Self-assessment form
Every odd-numbered year before July 1st
Which naloxone formulation has instructions
Evzio has visual and audio instructions Protocol covers ALL FDA-APPROVED formulations
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)
Time period a schedule V must be filled or refilled before it is void
Expires 6 months from date the prescription was written.
True/False: RPh may electronically enter a prescription for Xanax into a pharmacy's or hospital's computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital.
False! Can do this with non-controlled, but cannot do this with C2-C5.
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
If the CIII indicates that it may be refilled PRN then the pharmacist must respond to this by...
Filling original X, but unable to refilled the med until clarify with MD the number of refills (1-5 in 6 mo period). NO RX that is controlled is allowed to be PRN refills.
What is something that an inspector cannot do?
Fire the PIC
Photosensitivity
Flagyl INH Retinoids Ritonavir & a few other HIV drugs Sulfa abx Tetracyclines NSAIDs Diuretics (FIRRST ND)
Discoloration
Flagyl Levodopa Entacapone Macrobid Phenazopyridine
Veramyst
Fluticasone
When can you split a CII?
For insurance purposes (30 day insurance/ 30 days cash)
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
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
Transfer CII to original supplier
Form 222 needs to be issued
dalteparin Brand?
Fragmin
New PIC must complete full inventory of ___ within ___
Full inventory of all *C2* within *30 days of becoming PIC*
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
Compounding sterile injectables from nonsterile ingredients
ISO class 5 laminar airflow hood with ISO class 5 or 7 cleanroom. Certification for sterile compounding records should be maintained for at least 3 yrs. For parenteral cytotox agents --> MUST use Class II type A or type B vertical laminar air flow hood with bag in bag out design
When can pharmacy permit be voided?
If no activity in one week for 4 months
Can a CII be filled for less than what was prescibed?
If pharmacy is out of stock, you can partially fill it. BUT it must be filled within 72 hours. If a patient requests a smaller amount than what is written on the precription, the physician must be notified and the remainder must be voided.
Can RPh furnish schedule II-V drugs?
If practicing under a physician, must have DEA number
When can CII be written on regular Rx blanK?
If pt is terminally ill. Write 11159.2" (use clincial judgment). Submit to CURES as usual.
What can a community pharmacy have 2 techs per Rph?
If they are filling inpatient orders for a licensed healthcare facility or a home health agency
Reporting Time Period? Loss/theft of controlled drugs
Immediately
Within how many days must the board be notified in the case of a bankruptcy, insolvency, or receivership
Immediately in writing
If a pharmacy declares bankruptcy, they must contact the board of pharmacy _______.
Immediately or within 72 hours in writing
When to notifiy BOP if pharmacy goes bankrupt?
Immediately within 3 days.
Classes with MedGuides
Insomnia drugs Some antipsychotics: Abilify, Seroquel LABAs Antidepressants ADHD drugs NSAIDs DM drugs Retinoids Most antiarrhythmics: amiodarone
Eaxmples of C V
Lacosamide (Vimpat) Pregabalin (Lyrica)
Licensure expiration
Last day of pharmacist's birth month
What is a requirement for clinic dispensing meds?
License through BOP Cannot dispense CII
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
Formulations that cannot be substituted
Long acting and short acting forms Combination drug and multiple single agents
Who can call in CII prescription?
MD only in an emergency. Within 7 days, pharmacy must receive secure prescription. Otherwise, cannot. RPh must notify DEA 6 days if not received. Records retained for 3 years.
For a prescription for Ambien (Zolpidem - C4) #100 with 5 refills. Is the patient entitled to all 5 refills?
MD wrote for Ambien #100 Take 1 QHS w/ 5 refills - This is a 100 day supply NO. So with this prescription, you'd have to call MD for authorization after 1 refill because refill #1 will give 100 day supply and refill #2 will push it to 200 day supply. (i.e. refill #2- 5 cannot be filled)
Who can prescribe without a protocol?
MD, DO, Dentists, podiatrists, veterinarians, optometrists. (bone, teeth, foot, eyes, owls - within scope of practice)
Independent authority prescribers
MD/DO dentist podiatrist (DPM) veterinarian (DVM) optometrist (DO) ** naturopathic doctors (ND) **
DEA form 225 is registration for?
MFG, distributer
Avinza
MS ER
Kadian
MS ER
What has to be on a unit dose med?
MUST HAVE BARCODE Lot#
Quality Assurance Records
Maintained x 1 year
Mediation error/QA reports.
Maintained x 1 year.
Patient medication profile.
Maintained x 1 year.
Pseudoephedrine, ephedrine sale logs.
Maintained x 2 years.
Pharmacy Technician Compliance (training) records maintained for...
Maintained x 3 years
Biennial CS inventory record.
Maintained x 3 years.
CS Inventory.
Maintained x 3 years.
Community or Clinic pharmacy prescriptions.
Maintained x 3 years.
DEA Form 222
Maintained x 3 years.
Hospital pharmacy chart order records for non-CS.
Maintained x 3 years.
Theft and loss reports of controlled substances (DEA Form 106)
Maintained x 3 years.
Transaction info, transaction hx, transaction statements for each drug product received ex: when selling/transferring drugs (transferring ownership of a drug)
Maintained x 6 years.
PIC
May serve as a PIC at 2 pharmacies as long as the 2nd pharmacy is not more than 50 miles. Can't serve as PIC if already an exemptee in charge for a vet drug food retailer at another site.
Exp date on the label
May use up to 1 year exp date or manufacter exp date on label
Isotretinoin
MedGuide REMS Blurred vision Photosensitivity
NSAIDs
MedGuides Photosensitivity CI in CrCl < 30
Where do report serious adverse reactions?
MedWatch
MERP vs MedWatch
MedWatch is for drug name issues (e.g. Brintillex --> Trintellex) and adverse reactions MERP of ISMP is for med ERRORS
Reporting form for reporting serious reactions
MedWatch program FDA 3500B
MUE
Medication Use Evaluation: A method that evaluates how medications are being utilized to treat patients in the hospital.
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)
Medication Guides
Medications that have significant health concerns - antidepressants, some antipsychotics, anticonvulsants - Insomnia drugs - ADHD drugs - Retinoids - Diabetes drugs - LABAs - most antiarrhythmics - NSAIDs Community: EACH TIME drug is dispensed Outpatient: first time drug is dispensed to MD for administration to a patient in outpatient setting Approved by FDA
When can you not respond to a price request?
More than 3 requests in 6 months Controlled substance over the phone Request from competitor Request from out of state
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
If no security rx for schedule II drug is sent by prescriber pursuant to an emergency oral order-time period notification to DEA
Must contact the National Bureau of Narcotics within 6 days (144 hours) after 7 days of the emergency oral order
APh CE
Must do additional 10 CEs every 2 years (total of 40 CE Q2yr)
What if you fail CPJE 4 times?
Must enroll in pharmacy school and complete 16 semester units of additional coursework
What must a pharmacist complete to be recognized as an APP?
Must have 2 out of the 3: - Earn certification in a relevant area of practice, such as amb care, critical care or oncology - Complete a residency program - Provided clinical services to patients for 1 year under a CPA or protocol with a physican, an APP pharmacist, a pharmacist practicing collaborative drug therapy management
Sale of hypodermic needles & syringes
Must have RX OR patient known to pharmacy & previously had RX. Other exception to RX requirement = for animal use or speciality declared disease prevention programs such as AIDs & Hep C prevention & pharmacy (max of 10) for pt > 18+ yo or HIV prevention (max 30)
Hospital <= 100 beds pharmacist requirement
Must have a consulting pharmacist Doesn't need a FT pharmacist
Patient medication profiles
Must keep all patients for ONE YEAR from date of last Rx EXCEPT when pharmacist feels that patient WILL NOT COME BACK
*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
Transferring OR closing of business (with controlled substances)
Must notify DEA in writing *at least 14 days* prior to the closing or transfer. A complete inventory must be done the day of transfer. Form 222 must be issued to transfer CII
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
If licensed employee admits to using drugs illegally
Must report to BOP within 30 days. It is customary to suspend employee from work pending an investigation or terminated from employment. Non-licensed parties such as clerks don't have to be reported, but incident must be reported within 30 days to board of missing or stolen drugs
Suboxone
Naloxone w/ Buprenorphine (CS 3) Used for opioid addiction, Sublingual tablet and film
Pseydoephedrine Transaction Requirements
Name Address Date and time of the sale Signature in logbook *keep log book for 2 years
What do you have to record for a state of emergency prescription?
Name address of patient Date of service Name strength quantity of drug
What are the requirement of repackaging already dispensed med?
Name and address of BOTH the repackaging pharmacy and the pharmacy that initially filled the prescription
What are prescription label requirements?
Name and address of pharmacy Name of the prescriber (prescriber or supervisor) Date of issue, expiration, quantity Name of patient, med directions description
What is the labelling requirement for compounding products?
Name of BOTH compounding pharmacy and dispensing pharmacy Active ingredient info Instructions for storage, handling , and admin BUD Compound date LOT NUMBER
What is required on Pyxis labelling?
Name of drug Strength dosage form Manufacturer Lot number Exp date
What is required to be written on the label of a drug prescribed under protocol?
Name of either the supervising or the protocol Prescriber Both not needed
If a PA writes a controlled prescription what has to be on it
Name of supervising physician Address " Telephone " DEA of PA
Each of these four items must be clustered into one area on the label taking at least 50% and must be at least 12-point sans serif typeface:
Name of the patient name of the drug and the strength the directions for the use of the drug the condition or purpose for which the drug was prescribed
What must be included in record for sterile compounding?
Name, LOT#, Amount, Exp date
What must be included in Rx written by PA, NP, CNM, ND?
Name, address, phone# of supervising MD, and Printed/Stamped name and license# of prescriber and signature
What classes of drugs are CII?
Narcotics, Stimulants and SOME barbiturates (suppositories are CIII)
A male customer with allergic rhinitis is requesting nicotine replacement therapy. Which one will the pharmacist least likely to furnish?
Nasal spray
How long do e-prescriptions need to be kept?
Need to be kept electronically for 3 years
What is a DEA form 363?
Needed to operate a controlled substance treatment program.
What is the only condition that you can re-dispense a returned drug?
Never
Can an intern counsel while pharmacist is on a break?
No
Can pharmacy receive samples?
No
Do non-Rx needles need to be documented?
No
Do you have to put the generic name on the label for a brand dispensed drug?
No
If a hospital has 100 beds or fewer, does that hospital require a full-time pharmacist?
No
Can a physician prescribe Lomotil for himself?
No (C-V)
Should The statement "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" appear on the container of Ezogabine?
No (C-V)
A 16 year old male comes to the pharmacy without a Rx asking to buy Plan-B. Can he get it?
No (Plan-B OTC only sold to >= 17 years)
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
Age restriction to buy emergency contraception
No age restriction
Multiple pre-printing Rx caution?
No controlled substances can be written unless on security form
Is there a limit to CII partial fills for a long-term care facility patient?
No limit. As many times as they want within 60 days
Is there a limit to CII partial fills for a terminal patient?
No limit. As many times as they want within 60 days
Multi-dose vials expiration date after puncture
No more than 28 days
How many hypodermic needles can be dispensed? To who?
No rx required. No quantity restriction. *18+yo.*
Can MD prescribe for treatment (suboxone) of addiction?
No unless MD has 2 DEAs. 2nd one with "X". Can't be written by PA under protocol.
Can a RPh give prescription info to husband?
No unless consent to release
Can you buy PSE underage?
No, 18 or older
Can you file all your controlled Rx's together?
No, C-II is separate
Does a pharmacist have to be present with technician at a remote dispensing site?
No, but has to use a telepharmacy system at least Has to use BARCODE technology
Can a PIC be in charge of 3 pharmacies?
No, just 2
Can the Rph overseeing an automated unit be out of state?
No, must be IN CALIFORNIA
Should you put manufacturer name if the brand is dispensed?
No, not necessary
Can you buy a mercury thermometer OTC?
No, only by Rx If it breaks, everyone leave the area earth911.com
If a RX is written by a PA, NP, CNM, or Rph pursuant to MD authorized protocol, does MD name still need to be on RX label?
No, only name of PA, NP, CNM, or Rph is fine. May prescribe controlled meds pursuant to MD protocol IF registered with DEA
Is it illegal to ship controlled substances?
No, you can ship CII's that you filled for out of state. RX to the originating state (in fact, you have to)
Are DEA 222 forms void if there are errors?
No, you can still use them with good judgement
Can you give an emergency supply in the same bottle?
No, you have to give them a NEW bottle with proper labelling Tell them there's no refills and that you are trying to contact the physician
Can a clerk take prescription drugs off the shelf?
No.
Patient wants 10 of 30 Norco. Can he?
No. 20 will be voided. Unless out of stock. Fill within 72 hrs.
If a physician is working temporarily at an office where his name is not preprinted on that office's prescription form, can the physician use that office's prescription form to write a schedule II prescription and hand-print his name and DEA number on it?
No. A prescription form for CIIs shall be printed with "The pre-printed name, license number, federal controlled substance registration number, and address of the prescribing practitioner." The prescriber could use his or her own prescription form, and note on the prescription the location where the patient was seen and prescriber's phone number.
Can hospital ER dispense medications?
No. Can dispense 72h supply until OP pharmacy can fill it.
Can you FAX CII Rx?
No. Can email Long-term care facilities in hospice can be faxed
Can Techs take new Rx over the phone?
No. Can take non-controlled refills.
Can optometrist write prescription for Norco?
No. Codeine ok (limited to 3 days)
Can triamcinolone cream be switched to ointment?
No. MD verification needed.
Can you give a pharmacy inspector a copy of the prescription?
No. Must be original. Photocopy is for yourself.
Can you partial fill CII?
No. Must complete in 72 hrs unless terminally ill (60 days)
If dentist writes for Aricept. OK?
No. Out of scope of practice.
Can you put 5 pills of clonidine as an emergency supply in old bottle?
No. Put drugs in new container with proper labeling. On back of rx record date, amt dispensed, reasons for dispense and RPh initials
Mistake on DEA 222. Cross out and sign?
No. Start new
Joe is a PIC of 3 pharmacies. Is this legal?
No. Up to 2 pharmacies. Within 50 miles.
Can you have Medicare Part D without A or B
No. You need at least one of the others
Can you sell 2% povidone iodine?
No. for >1% betadine or povidone iodine or 2% tincture of iodine
A 17 year old male wants to buy Plan-B one step without a Rx but he wants the medication to be covered by insurance. Can he get it?
No; Rx for EC can only be furnished to female patients
Is oral Rx of tapentadol valid?
No; oral Rx for C-II drugs are not valid except under emergency situation
Can a pharmacy dispense a Opana Rx to a patient that is from out of state?
No; out-of-state C-II Rx can only be delivered to originating state
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
Emergency refills
Non-controlled and CIII-V drugs can be filled if MD unavailable and not filling can cause harm to patient Must document and contact MD
Non-controlled records can be moved to an off-site storage after ___.
Non-controlled prescriptions must be kept for a total of 3 years, but it can be moved *after 1 year* from the last date of dispensing
Converting 30 to 90 day
Non-controlled, non-psych drug Completed initial 30 d with no issues Total quantity does not exceed amount authorized Pharmacist notifies MD UNLESS Rx states "no change to quantity" etc.
Can Rx can be transferred?
Non-sched and CIII-CV.
How many times can a C-II drug Rx be transferred?
None
Pharmacist to clerk ratio
None
Pharmacy A and Pharmacy B share a real-time, online-database of patients. How many times can a Rx of Tussionex be transferred between Pharmacy A and B?
None (C-II cannot be transferred)
Limit on hypodermic needles
None!
Do topicals or non-oral prescriptions need to be in a child proof container?
Nope
Who has to be present for PSE purchase
Not a requirement for pharmacist to be there
Fictitious name for celebrities on prescriptions
Not allowed
If you are filling a prescription for OPIOID addiction, your DEA must start with the letter ___.
Not every prescriber can write for addiction. A prescriber's specific DEA number must start with the letter "X." Prescribers must have a DEA # and also a second DEA # with the letter "X." A prescription for *opioid dependence* must have BOTH numbers. Only the regular DEA number is required when these meds are written for pain control. Prescribers may only treat 100 patients at one time. This is the maximum. Prescribing or dispensing to patient of these drugs may not be done pursuant to a protocol (by nurse or PA)!
Class III Recall
Not likely to cause adverse health consequences
Class III recall
Not likely to cause any serious adverse effects and does not go to the customer level
Counseling in inpatient
Not req'd to consult patient on each med while inpatient, but must provide discharge counseling of all discharge meds.
Translation
Not required to translate beyond what's provided by the board Must supply English directions for use on label or as supplemental document
How often to renew compounding from BOP for hospital pharmacy or SNF?
Not required. Accredited by JCAHO.
Dr. B calls your pharmacy to authorize an emergency fill of Kadian on Monday. It is Friday today and you noticed you have not received a written Rx from Dr. B. What do you do?
Nothing; the written Rx need to be provided by the 7th day following the oral authorization; today is the 5th day
Wholesaler reporting requirement
Notify BOP of suspicious orders
What if a disposal machine is tampered with?
Notify BOP within 14 days
What are options if a drug is out of stock
Notify the patient and arrange for timely delivery Transfer it to another pharmacy Return and refer to a nearby location
Which diabetes meds can be at room temp for 42 days?
Novolin R/N/combos Levemir Glargine (Toujeo)
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
Who can prescribe under protocol
Nurse Practitioners PAs Naturopathic Doctors Certified Nurse Midwives Pharmacists
Prescribing authority: Prescribing w/ a protocol related to scope of practice
Nurse practitioners Physician Assistants Certified Nurse-Midwifes Naturopathic Doctors Pharmacist
Which of the following is a valid DEA number for Noel Okumura, NP?
Nurses are mid-level practitioners (MLPs). The first letter of the DEA number for MLPs start with an "M". The second letter of the DEA number is the first letter of the practitioner's last name.
Compounded products for prescribers
OK for administration or application in the prescriber's office NOT OK for prescribers to furnish/dispense to human patients VETS OK to purchase and furnish/dispense up to 120-hr supply for vet patients
Substituting drug formulations
OK if a different formulation will improve compliance, UNLESS MD indicates no substitution allowed
Substituting biosimilars
OK if considered interchangeable in Purple Book UNLESS MD indicates do not substitute Biosimilar cannot cost more than reference product
Repacking previously dispensed drugs
OK to repackage into blister packs etc to increase compliance and reduce med errors
Compounding ahead of time
ONLY allowed if a limited quantity of compounded product in advance if that quantity is necessary to ensure continuity of care for an identified population of patients based on documented history. Not more than 72 hr supply for office use.
*Internet Prescriptions* (p. 24)
ONLY dispensed to the pt if the prescriber has *PERFORMED* an examination
Can you fill an out of state CII?
ONLY if you deliver it back to the state it originated
Can clerks take in a phone Rx?
ONLY refills NOT requiring changes
Regulation status for one-pill levonorgestrel 1.5mg as EC
OTC and Rx
When is open enrollment for Medicare?
October 15 - December 7
Multiple CII scripts given to 1 patient
Ok & valid if meets all CII requirements & ONLY for max of 90 day supply
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
How many times can a C-III, C-IV, C-V drug Rx be transferred?
Once
How many times can you transfer CIII-CV medications?
Once
Pharmacy Q and Pharmacy L are two independent pharmacies in Seattle. How many times can the Rx of Butisol be transferred between Pharmacy Q and Pharmacy L?
Once (C-III)
What do you have to do if CIII-CV are filed with your non-controlled prescriptions?
One inch red letter C on lower right hand corner of Rx
When can you NOT have a patient profile on record?
One time fills for patient they think will never return
PRN refill
One year or less from the date the prescription was written without contacting the prescriber
Ryan Haight Act?
Online pharmacy must register for DEA.
Transferring CIII-V
Only 1x
Can controlled be filed with non-controlled?
Only CIII-CIV (with C). Not CII.
DEA FORM 222
Only CS 1-2 are ordered w/ the DEA form 222, or the electronic equivalent. A DEA form 222 is required for each distribution, purchase, or transfer of a schedule II CS. Keep the copies for 2 years (Federal) and 3 years (California), and keep separate from other records. After filling out the form, remove the last copy (blue) and file it. Don't separate the first two copies (brown and green) of the form. Vendors can only accept forms w/ these two copies attached and with the carbon intact.
Who is responsible for automated units?
Only a pharmacist can stock, etc.
Who can sign for the receipt of drugs from the wholesaler?
Only an RPh or intern can sign for receipt of drugs from the wholesaler.
When can a CII-CV be written on a regular prescription blank (non-security form)?
Only when the blank has the numbers 11159.2 For terminally ill patients only
Can a physician prescribe to themselves?
Only within their scope and NEVER for controlleds
What should go down the toilet?
Opioids, Daytrana, Diastat
Whose license? 12345-T
Optometrist
Prescribing authority: Prescribing w/in scope of practice, but don't need a protocol
Optometrists Podiatrists Veternarian Dentist
Technician's work must be checked by...
Outpatient: pharmacist Inpatient: pharmacist, technician (TCT)
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) are regulated by Sate Board?
Outsourcing facilities, traditional compounding
child resistant packaging
PCP can request no-child resistant packaging PER RX while patient can do a blanket request for ALL rxs they fill
CIIIs-CVs can only be faxed if
PCP manually signs Rx before faxing over
Vaccines administered to any patient
PHARMACIES (not pharmacists) must register with CAIR (California Immunization Registry), while pharmacists must report administration to CAIR
PIC
PIC completes a biennial pharmacy self-assessment before July 1st each odd numbered year. An additional self-assessment completed 30 days if a new permit is issued or a new PIC employed. Each self assessment maintained in the pharmacy for 3 years. PIC in charge of 2 pharmacies must be w/in 50 driving miles of each other. A change in PIC is reported by the pharmacy and the departing PIC to the board in writing in 30 days.
Who can sign DEA 222?
PIC or anyone with power of attorney
Second generation cephalosporins
PO: Cefaclor Cefprozil Cefuroxime Loracarbef IV: Cefotetan Cefoxitin Cefuroxime
Where is the BBW located?
Package inserts Not necessarily the Med Guide
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*
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
What is not a legal requirement of pharmacy techs?
Pass an exam administered by BOP in order to be granted pharmacy tech certification
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
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
State of emergency allowance
Pharmacist may furnish reasonable quantity (72 hours usually) of all RX including scheduled II-V & nonscheduled to a patient during state of emergency even if patient doesn't regularly fill RX at pharmacy IF good evidence that patient has been on med. LOG patient's information, information about drug, & MD information. Notify MD ASAP of dispension
Vaccines administered to pregnant patients
Pharmacist must notify PCP within 14 DAYS or advise to consult with a provider
Patient Consultation Regulation
Pharmacist or pharmacy intern must provide ORAL consultation to patient. If hospital discharge, someone other than pharmacist may provide discharge counseling to patient about new meds. When RX is delivered then responsibility of patient to request consultation. INCLUDE: directions, storage, importance of compliance, precuation & warning ADR
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
Adverse drug reaction occurs with a manufactured drug. What steps are taken? (1)
Pharmacist to notify MedWatch.
Who can receive oral rx?
Pharmacist, pharmacy intern
Who do not need to consult CURES before each new CS rx?
Pharmacists and vets - RPh already do more than anyone!
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
Pharmacy Z orders C-II drug from manufacturer A, who keeps DEA-222 copy 3?
Pharmacy Z
If patient request price for > 5 rx & no valid rx
Pharmacy may request that price request is in writing & prices can be given in 10 days; may charge fee for EACH prescription price quote but inform patient first; NOT required to respond to > 3 requests for a single person in 6 mo period; CS telephone requests don't have to honor; do not have to respond to competitor, do not have to respond to out of state requester
Information on RX prices
Pharmacy must place BOP notice to consumers of the availability of RX price info. Pharmacy shall give current retail price for any drug sold if requested.
Definition of a pharmacy being Closed down
Pharmacy no longer engaged in activity it was licensed for, or not operating at least 1 day per wk in a 120 day period
Bactrim
Photosensitivity Take with plenty of water Do not refrigerate Dextrose
What are the restrictions on buying OTC EC?
Plan B One step (1 pill formulation): No restrictions 2 Tablet levonorgestrel products: must be >17 yo
May cause blurred vision
Plaquenil PDE 5 inhibitors INH Isotretinoin Ethambutol Scopolamine patch VFEND Amiodarone Anticholinergics Tamoxifen Ketek (PPIIESVAAT K)
Only case that a pharmacist can fill a prescription or non-controlled drug and schedule III-V drugs without prescriber's authorization
Prescriber is unavailable and in the pharmacist's professional judgement, failure to refill the prescription might interupt the patient's ongoing care and have *significant adverse effects*
In a hospice, what are requirements if a portable container is opened?
Prescriber sends a signed hardcopy within 20 days Once seal is broken, container is sent back to pharmacy within 7 days
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
DATA 2000 (p. 91)
Provision that permits prescribing of narcotics for opioid addiction treatment
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
Combat Methamphetamine Epidemic Act of 2005
Pseudoephedrine/ephedrine/phenylpropanolamine. Must be behind the counter or locked in cabinet. Record keeping: name of purchaser, address, date & time of saline, amount of product sold. *Maintain record of pseudoephedrine/ephedrine purchases for 2 yrs.* *The buyer must be 18 years old.* The maximum amount purchasable: -no more than *3.6 g/day* -no more than *9.0 g/mo* -no more than *7.5 g can be imported in a 30-day period (mail order).*
Maintain x at least 6 yrs
Pt acknowledgement of HIPAA
Maintain x at least 1 yr
Pt med profile Med error/QA reports
DAW-2?
Pt preferred "No SUB"
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
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
How often are laminar air hoods and clean room certified? (sterile compounding)
Q6mo (updated info for 2018)
What must be done before allowed off-site storage of records?
Receive a waver from board of pharmacy *Board will returned signed waiver within 30 days *The pharmacy must produce the records within 2 days of request
self-assessment pharmacy records
Records must be kept for 3 yrs. Completed by July 1st each ODD year (biennial. Complete self-assessment within 30 days of a new pharmacy permit issuance or change of PIC
Records of PURCHASE and SALES of drugs and medical devices must be retained for how many years?
Records must be retained for 3 years from the date they were created.
DEA Form 363
Registration form for narcotic treatment programs
DEA Form 224
Registration form for retail pharmacies, hospitals, practitioners, teaching institutions, or mid-level practitioners Get DEA number
CII
Registration is required. Receiving records = DEA form 222. Written RX. No refills. Separate filing. Distribution between registrants require DEA form 222. Locked cabinet or dispersed among noncontrols. -Report to DEA immediately & complete DEA form 106. Maintain all records for 3 years. -Report to the CA BOP within 14 days.
CV
Registration is required. Receiving records = invoices that are readily retrievable. Written, oral, fax. As authorized when rx is issued or if renewed by physician. Separate filing or readily retrievable. Distribution between registrants require invoices. Locked cabinet or dispersed among noncontrols. Report to DEA in 1 business day & complete DEA form 106. Maintain all records for 3 years.
CIII-IV
Registration is required. Receiving records = invoices that are readily retrievable. Written, oral, fax. No more than 5 refills within 6 mo. Separate filing or readily retrievable. Distribution between registrants require invoices. Locked cabinet or dispersed among noncontrols. -Report to DEA for any theft or significant loss immediately & complete DEA form 106. You must notify the BOP within 14 days of theft/loss. Maintain all records for 3 years.
First step of hospital recall
Remove med from all patient care areas
How to administer Narcan
Remove yellow caps off syringe Screw on white cone Take purple cap off capsule of naloxone Screw capsule of naloxone into syringe Insert white cone into nostril Give a SHORT, STRONG PUSH to give HALF into EACH NOSTRIL If no reaction in 3 MINUTES, give second dose
Monitor in Amphoteracin B treatment? (3)
Renal Liver K+
DEA form 224a
Renewal application for pharmacy
What is DEA form 224a?
Renewal application for pharmacy
DEA 106
Report Theft or Significant Loss of Controlled Substances
DEA 41
Report any destruction of a CII (planned disposal or accidental breakage/spillage)
What do you do if you lose a secure Rx form?
Report immediately (no later than 3 days) to CURES/PDMP (Rx Drug Monitoring Program)
What to do if controls stolen? Impairment noted?
Report to BOP & DEA immediately within 14 days
Loss/theft of controlled drugs
Report to DEA immediately (1 day) Report to CA BOP w/in 30 days
When a PIC is being changed, what is normal procedure to report the change?
Reported by the pharmacy and the PIC to the board in writing within 30 days
DEA form 106
Reporting the Theft or Significant Loss of Controlled Substances
DEA Form 106
Reporting the theft or significant loss of controlled substances
Requesting DEA forms for the first time
Request initial 222 forms w/ DEA form 224 additional DEA forms can be ordered via DEA website
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"
Patient package insert
Required for all drugs containing estrogenic agent
Rx Transfers (p. 27)
Required info: 1. Name of pharmacy 2. original date and last fill date 3. number of refills remaining
REMS
Required of manufacturers to ensure benefits outweigh risks when BBW and MedGuides may not be sufficient
What is the policy of converting a 30 day Rx to 90 days?
Requirements for conversion: - Already completed initial 30 days supply or patient previously received 90 day supply - Total quantity dispensed does not exceed the amount authorized on the prescription - Pharmacist notifies the prescriber of the increase in the number of days supply dispensed
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
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
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*
What schedule is a codeine 15 mg tablet in?
Schedule II
Which controlled substances are required to have the following statement on their auxiliary label? "Caution: Federal Law prohibits transfer of the drug.."
Schedule II-IV
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
11167 exemption
Scheduled 2-5 drugs must be written on tamper-resistant forms purchased from state approved designated security printing companies. Dr. can use 11167 exemption if they run out of security Rx and pt needs meds. Pharmacist must watch for the security Rx to arrive in 7 days (or postmarked by then). If not received then report that prescriber.
DEA 363
Separate DEA registration as a Narcotic Treatment Program. Must request to be a DATA waved practitioner. May treat 30-100 patients at a time. Has unique ID number beyond DEA number
Who can prescribe under protocol?
Naturopathic doctors, PA, NP, cert nurse midwives, pharmacists
Internet RX
Need name or initials of person sending whether the MD or his or her designee & assurances med was ordered as result of good faith exam on the part of the MD
Form 224
New Application for Pharmacy
What is a DEA form 224?
New Application for Pharmacy
Are PRN refills allowed for CII-C-V drugs?
No
Can intern consult while RPh is on break?
No
Is DEA # FE 3859142 valid?
No
Is it permissible for a pharmacist to be a PIC of a pharmacy and a designated representative-in-charge (DRIC) for a wholesaler or a veterinary food-animal drug retailer at the same time?
No
Schedule III, IV, or V controlled substance preprinted on a multiple check-off prescription form that is not a special security form. Can you fill?
No
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
Drug sample
No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. Rph can not even charge dispensing fee for preparing drug sample. Must provide at no charge
Can a P and T committee only have physicians?
No, at least one pharmacist and one physician
Is there an age restriction on Plan B One-Step?
No. Any kid can pick one up. (Levonorgestrel?)
Can a pharmacist furnish nicotine replacement therapy to a pregnant woman?
No; refer to physician
What is the blue container for?
Non-Bio-Hazardous
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
How long must noncontrolled and controlled prescriptions be maintained ON-SITE for?
Non-controlled: 1 year Controlled: 2 years
How many times can a Rx be transferred between pharmacies for non-controlled, schedule II and schedule III-V.
Non-controlled: as many times Schedule II: cannot be transferred Schedule III-V: once, unless using the same pharmacy software system (i.e. walgreens system)
Must oral and e-data Rx be reduced to writing?
Not if it can be retrieved 3 yrs from last dispense
What is the maximum BUD for multi‐unit containers?
Not later than (a) exp date on manufacturer's label or (b) 1 year from date drug dispensed
DEA FORM 222
ORDERING/TRANSFERRING CONTROLS
one pill levonorgestrel: OTC age and gender restriction
OTC: no age/gender restriction
On site storage requirements
On site also includes a building/storage area directly attached to the premises (or the same address).
How many times can you transfer a CIII-CV? Is there an exception?
Once Exception is if you share a REAL-TIME online database
How many times can Vimpat be transferred?
Once (for C3-C5)
What must a doctor do for a do not substitute?
They must initial by the DAW. They don't need to initial for electronic transmissions
How do new owners deal with the pharmacy permit?
They need to get a new one They can get a temporary for 180 days
Drug Addiction Treatment Act (DATA) 2000
This act permits physicians who meet certain qualifications to treat opioid addiction with Sch 3-5 narcotic meds that have been approved by the FDA for this indication. Such meds may be prescribed and dispensed by waived physicians in tx setting other than the traditional Opioid Tx program (methadone clinic) setting. If prescriber has the waiver their DEA number starts with an X.
Transferring CII, which DEA 222 to keep as PIC?
Top. Brown.
Return of CII, which DEA 222 to keep as PIC?
Top. Brown. (who has the drug?)
What is the yellow container for?
Trace chemotherapy
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) require individual Rx?
Traditional compounding
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
What is the policy of valid prescriptions if a physician is deceased?
Valid until... i. All refills are gone ii. 6 months after issue date for controlled substances iii. 1 year for non-controlled substances
How should a brand name Vicodin read on a label?
Vicodin (Not Brand + Mfg like generics)
Can the pharmacist fill less than the full amount on a CS 2 script
When the pharmacy doesn't have sufficient stock of drug; remaining portion must be filled w/in 72 hours, if not a new security Rx must be written for remainder by prescriber. When the pt request less than what is ordered, the pharmacist must contact prescriber for approval of small amount. Must indicate on Rx. lesser amount approved of and note was ok by prescriber. Cannot fill remainder at some later date. This would constitute a refill which id not permitted for CS2. Where the pt is terminally ill and at a SNF/hospice, the Rx may be filled in increments based upon condition of pt. Rx must be filled w/in 60 days from date written, and increments may be provided over a 60 day period from date written.
Notify CABOP of changes in the pharmacy permit.
Within 30 days.
Period of time rx records must be produced from an off-site storage facility when requested
Within 48 hours
Period of time PIC must do investigation & report once a medication error is discovered
Within 48 hours of discovery error
Home health portable containers must be returned to the pharmacy for inventory when?
Within 60 days or 7 days from broken seal
Schedule II security rx to be sent by prescriber to pharmacy pursuant to an emergency oral order by prescriber
Within 7 days from date written.
How long do you have to complete a partially filled CII for an OUT OF STOCK CII?
Within 72 hours
Notify CABOP of bankruptcy, insolvency, receivership
Within 72 hours in writing (or Immediately)
Offer to counsel on mailed Rx
Written notice that pharmacist is available and telephone number
Does a condom prescription for a MediCal patient need to be on a security pad?
YES IT DOES!!! WOW
is partial filling of schedule III-V allowed?
YES but cannot dispense >6 mo since written
Can a secretary of a physician call in a CIII?
YES!
Can you be emailed a CII?
YES!
IS AL 8010869 an authentic DEA number
YES. 8.1.8=17; 0.0.6=6x2=12; 17+12=29; 9=9;
How often must a compounding pharmacy license be renewed?
Yearly
If compounding low-medium risk level medications, the pharmacist/tech's technique must be evaluated _________.
Yearly
Gloves used when opening chemo?
Yellow waste
A 15 year old female comes to the pharmacy without a Rx asking to buy Plan-B one step. Can she get it?
Yes
A 18 year old male wants to buy Plan-B without a Rx. Can she get it?
Yes
Are PRN refills allowed for non-scheduled drugs?
Yes
Can CV cough medicine be written for family with same need?
Yes
Can a certified nurse MIDWIFE write for C II's?
Yes
Can pharmacy A sell controlled substance to pharmacy B without acquiring status as a distributor?
Yes
If a pharmacy compounds, does it require a compounding license?
Yes
Is DEA # BT 6835752 valid?
Yes
Sig has changed on a an Rx. Is a consult needed?
Yes
Counseling required if new written Rx for same med?
Yes Also if different dosage form or different strength
Can you deliver controlled substances thorugh UPS?
Yes There cannot be indications on the box of what is inside
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
Should The statement "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" appear on the container of Seconal?
Yes (C-II)
Should The statement "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" appear on the container of Belviq?
Yes (C-IV)
Can Cipro tablets be substituted from Cipro Solution with MD?
Yes as long as equivalent dose
Can a optometrist prescribe hydrocodone?
Yes but only for a 3 day supply
Can RPh provide Emergency supply without refill auth?
Yes for non-scheduled and CIII-V. NS = partial or full. C3-C5: reasonable qty
Can MD write in his name and DEA number for controlled substance in a group practice >25 ?
Yes if CIII-CIV. No for CII.
Can a Rx for Valium dispensed on oral order?
Yes if there is an emergency. Or any other order (electronic, written)
Can CII's be called in?
Yes only in an emergency and only by the physician
Can clinics buy drugs at wholesale to administer/dispense?
Yes, but they must be licensed by the Board of Pharmacy. Clinics can administer a CII, BUT they cannot dispense CIIs Clinics can dispense a c3-c5 All records of dispensing must be kept for atleast 3 years.
Cana prescriber dispense drugs?
Yes, if properly labeled
Can you give meds to a patient from a deceased prescriber?
Yes, if you think it's reasonable. THIS IS EVEN OKAY FOR CONTROLLED
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
Can you fill a Puerto Rico atenolol RX?
Yes, only since it's a US territory DC, Puerto Rico, Virgin Islands, Guam, American Samoa (MEMORIZE THESE)
Can clerks type prescriptions?
Yes.
Can needles be sold without Rx?
Yes. 30 syringes to peopel >18 yo
Can CII Rx be e-prescribed?
Yes. All drugs.
Can a pharmacy take delivery of dangerous drugs if pharmacy close and RPh isn't present?
Yes. But: 1. drugs must be placed in storage facility in same building as pharmacy 2. Only PIC (or designated PIC) has access to storage facility 3. Secure storage records entry 4. Pharmacy has P&P for this 5. Delivery includes document of name and amt of each dangerous drug
Can a out of state C-V Rx be filled in CA?
Yes. CIII-CV. Phone in ok.
Does a community pharmacy need a license to compound?
Yes. Compounding requires a separate nontransferable license from the Board that is renewed on an annual basis upon Board's inspection.
Can a prescriber electronically transmit a Rx for CS 3-5 from a computer or PDA to a pharmacy computer or fax?
Yes. Current DEA regulations allow for CS 3-5 that are electronically created or transmitted, which includes PDA, either directly to a computer or via fax, be treated as an oral Rx. This means the Rx must be reduced to hard copy by the pharmacist and retained for at least 3 years.
Can an admin of MD office call in Rx?
Yes. Must document name (agent)
For a prescription for Tylenol #3 for a quantity of 30 is written as a 10-day supply with 5 refills. Is the patient entitled to all 5 refills?
Yes. The pharmacy may refill al 5 refills within six months because each refill will be a 10-day supply. Five refill would be a total of 150 tablets or a 50-day supply. Filling all five refills will not exceed the 120-day supply limit. Again, the initial dispensing is not counted as one of the refills.
Does pharmacy inspector have power to arrest
Yes. With reasonable cause.
Can a CA pharmacy deliver a testosterone Rx to a Colorado patient?
Yes; CIII-CV Rx from out-of-state can be delivered to originating state or be dispensed directly to patient
Is oral Rx of Lomotil valid?
Yes; oral Rx is valid for C-V drug
A 17 year old female wants to buy ulipristal without a Rx but she wants the medication to be covered by her insurance. Can she get it?
Yes; pharmacist can furnish EC to a female patient
District of Columiba, Guam, American Samoa, Virgin Islands, Puerto Rico
You can fill prescriptions as these are U.S. territories
What is allowed during a state of emergency?
You can refill meds regardless of whether they;ve ever been to that pharmacy and even if they have no refills
What if a C2 is written for a 60 day supply, but insurance only wants to pay for 30 days?
You can run insurance for a 30 day supply and run the other half as out-of-pocket. They only have 1 opportunity to pick it up.
Can you give an emergency supply without any refills?
You cannot do this for CII You can give a "reasonable" quantity for CIII-CV
Non-controlled loss or theft.
You contact the board within 14 days, but you do not have to contact the DEA
What happens if a prescriber doesn't send in a called in emergency CII prescription within 7 days?
You have SIX days to notify the DEA
When ordering CIII-V, what information must be kept on the invoice?
The pharmacy must keep the invoice or packing slip and each receipt must contain: 1. Name of each controlled substance 2. The finished form 3. The number of dosage units per container 4. Number of commercial containers ordered/received
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
notice requirement by board and response to notice by licensee if pharmacy is closing or license is voided
after notice, licensee must reply in 10 days
mobile pharmacies
allowed but has to be affiliated w/ a licensed pharmacy, has to be in area of disaster, and closed within 48 hours after emergency is over
Name some CII barbitruates?
amobarbital, pentobarbital, secobarbital
Who can purchase OTC Plan-B one step?
anyone
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
date that the the PIC has to complete biennial self-assessment form for their pharmacy
before _July 1st_ of each odd numbered year
Formulations that cannot be switched
between long-acting and short-acting forms between combination drug products to multiple single-agents
when self-assessment forms are completed
biennially before July 1 of each odd numbered year
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)
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
vaccine rules
can give to ≥3 yrs old need BLS must tell PCP within 14 days ned to tell CAIR need to keep vaccine admin record that is retreviable and provide pt with theirs
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*
Clerk duties
cannot PULL drugs can PUT drug on the shelf hand prescriptions at point of transaction
emergency refill limit: schedule II
cannot be dispensed without the prescriber's authorization
Limitations to multiple C-II drug Rx issued by the physician during the same office visit
cannot exceed 90-day supply in total
out of country prescriptions
cannot fill
treatment of oral thrush?
clotrimazole (Mycelex)
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
DEA form 363
compounding controlled substances, controlled substance treatment program
prescriptions by deceased prescriber valid for
controlled substances: 6 months from the date written non-controls: 1 year from date written
DEA 222 form breakdown
copy 1 is brown - this is whoever is SENDING the drugs (think UPS) copy 2 is green - this always go to the DEA copy 3 is blue - this is whoever is RECEIVING the drugs
Pharmacy A sends C-II drug to Company X for reverse distribution; which DEA-222 copy should Company X keep?
copy 3
for schedule III-V drugs: california pharmacies can fill and?
dispense directly to the patient
Therapeutic interchange
dispensing of medications by pharmacists that are chemically different, but therapeutically similar to the medication prescribed
For refills on C III and IV substances:
do NOT count the original fill in the 120 day, 5 refill limit. Note that you may not be able to fill refills IF they exceed the 120 day limit. For example, if you have 5 refills for a 30-day supply each, and the patient filled the prescription monthly, it would not be permissible to fill the last (fifth) refill.
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
Sales of CS from a pharmacy to other pharmacies or prescriber
don't exceed 5% of the total number of CS dosage units dispensed per calender year, otherwise a wholesaler registration is obtained from DEA and from the board.
Marinol brand and schedule
dronabinol Schedule III
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
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
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
for opened containers of schedule III, IV, and V controlled substances: if dosage unit is <1000, what count is required
estimated count
How often must a pharmacy license be renewed?
every 1 year
How often must a sterile compounding license be renewed?
every 1 year
DEA controlled substances inventory is performed?
every 2 years
How often must a pharmacist license be renewed?
every 2 years
How often to inventory controlled drugs?
every 2 years
how often to do controls inventory
every 2 years
controlled substances inventory
every 2 years with schedule 2s every 3 months
How often must a pharmacy DEA registration be renewed?
every 3 years
How often must a pharmacist/intern/tech complete an inspection of all floor stock and drugs maintained at a nursing station? When should tech report irregularities?
every 30 days to PIC AND Director of Health Care Facility within *24 hours*
How often does the pharmacy generate a controlled substance printout for refills of Schedule 3-5 prescriptions which contains the signature of the dispensing pharmacist?
every 72 hours and has dispensing RPh signature on it.
med guide
every time dispensed in outpatient just first time in inpatient setting
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
How should a schedule II drug be counted?
exact count
How should a schedule III drug, dosage unit >1000, be counted?
exact count
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
11159.2 exemption
exemption of a prescription for a controlled substance to be written on security form (terminally ill- expected death within one year)
Expiration on the Rx label?
expiration date from the manufacturer bottle, or 1 year from dispensing date, whichever is earlier
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
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
Emergency refill amount
full amount for non control. reasonable supply (72 hours) for control.
Conditions to furnish naloxone
if opioid overdose is suspected with symptoms including: *Extreme somnolence (cannot be awaken verbally or with a firm sternal rub)* *Respiratory difficulty* *Miosis (pinpoint pupils)* *Bradycardia*
Conditions that do no allow converting 30-day supply to 90-day supply
if prescriber indicates not to change quantity; controlled drugs; psychiatric drugs; negative effect after initial 30-day supply fill
only exception to the use of the california security form for C2s
if pt is terminally ill and will die within 1 year, PCP can write "11159.2 exception" on plain Rx form
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
when supplier must tell DEA that they supplied C2s (DEA 222 form vs. CSOS)
if through DEA 222: by end of month if through CSOS: 2 business days
only time faxed Rx for schedule 2 is valid
if written for pt of SNF or hospice
Bankruptcy, insolvency, receivership
immediately
Filing for bankruptcy, insolvency, receivership, notify board and DEA __________
immediately
Must report to DEA within how many days any loss/theft of controlled substances
immediately
Reporting Time Period? Bankruptcy, insolvency
immediately
Scheduled drug loss, notify board and DEA ________
immediately
Theft or loss of prescription forms must be reported ________ to the CURES/prescription drug monitoring program (PDMP).
immediately, no later than 3 days.
requirements to be able to furnish travel meds
immunization certificate program completed complete a travel med training program (at least 10 hours) complete CDC yellow fever vaccine course complete 2 hours of CE every 2 years on it must tell PCP within 14 days give pt written record of drugs provided good faith evaluation
Patient package inserts
in community setting, has to be given EACH TIME the specific drug is refilled (e.g. estrogen) in inpatient, just needs to be provided before first dose and the every 30 days afterwards
only time oral Rx for C2 is allowed
in emergency, pharmacist can fill enough of a schedule 2 drug to tide p over if pt is resident of SNF or hospice
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
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
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
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
Who can purchase BTC Plan-B?
male or female >= 17 years old
*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
Day supply limits for C-III and C-IV drug refills
no more than 120 day supply (refill only)
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
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
dea form 106
reporting the theft or significant loss of controlled substances
consumer med information
required just with each new Rx
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
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
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
Centralized Hospital Packaging requirements
the pharmacy's hospital and one or more general acute care hospitals under common ownership must be within a *75-mile* radius of each other
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
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
*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*
DEA 224
to register with DEA. Renewed Q3 years within 60 days of expiration date
DEA 106
to report any loss/theft of CS. Must be reported immediately
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
time period in which to electronically send in info on schedule 2, 3, 4 rxs per the CURES program
weekly
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
upon closure of pharmacy, a transfer of drugs notice must be provided to the board
within 10 days of closure and must be in writing
If a compounded drug preparation is recalled, within what time period should a pharmacy notify recipient & board?
within 12 hours
how many days must board be notified by the PIC is licensed employee of the pharmacy is involved in theft, diversion, or self use of a drug or exhibits impairment
within 14 days
How soon after the identification of medication errors should an investigation begin?
within 2 business days
blood clotting product dispensors must be able to supply products
within 2 business days to pt also must have a 24/7 customer help line
when you have to conduct a med error investigation
within 2 days of error
If a compounded drug preparation is recalled, within what time period should an outsourcing facility notify recipient & board?
within 24 hours
How soon should drug supply irregularities be notified? To whom?
within 24 hours; to the PIC and the director or CEO of the facility
If a new owner buys the pharmacy, they need a NEW permit. How many days does the new owner have to notify the CBOP?
within 30 days
Within how long of a significant loss of controlled substance be reported to the board of pharmacy?
within 30 days
how many days must the board be notified regarding change in pharmacy permit?
within 30 days
how many days must the board be notified of drug loss
within 30 days (if controlled, DEA must be notified immediately)
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
How long should a change of PIC be notified to the BOP?
within 30 days to the BOP
period of time rx records must be produced from an off-site storage facility when requested
within 48 hours
Amount of time patient must be able to inspect their medical records
within 5 business days of the written request and have physical copies within 15 business days
PIC can be in charge of another pharmacy with what distance?
within 50 miles - can only be in charge of 2 pharmacies total.
Number of days in which a prescription for a schedule II drug must be filled
within 6 months of the date prescription was written
partial filling for terminally ill patients/LTCF residents. what's the deadline to fill the remaining balance
within 60 days
A terminally-ill patient resides at SNF is prescribed Norco for management of pain. If the patient/caregiver do not want to pick up the entire prescribed quantity of Norco at once, within what time period can this Rx be partially filled?
within 60 days from the issue date
Time allowed to complete a C2 partial fill for terminally ill pt in hospice/long-term care
within 60 days of the date rx was written
schedule 2 security Rx to be sent by prescriber to pharmacy pursuat to an emergency oral order by prescriber
within 7 days
Pharmacy A is unable to supply enough quantity of Daytrana for a walk-in patient; within how long should Pharmacy A dispense the remaining quantity before the Rx becomes invalid?
within 72 hours
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
it is only ok not to dispense due to religious belief if
you tell your boss upfront and policies are put in place to make sure the pt will get the drugs
SubQ injections (p. 59)
≥ 12 months old: fatty tissue over the triceps < 12 months old: anterolateral thigh muscle 23-25 gauge needle 45ºangle
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
How often does each pharmacy submit dispensing data for C II-IV drugs?
Once weekly
Centralized hospital packaging allowed for hospitals within __ miles.
One or more acute care hospitals under common ownership with 75 MILE radius of each other
A P&T committee requires what members?
One physician and one pharmacist.
How may times may a schedule III, IV, & V controlled substance be transferred to another pharmacy?
One time
What are requirements for an emergency CII?
Only by a physician Must send a prescription hardcopy in within 7 days (very important)
Community ADDS requirement
Only for REFILLS that don't require counseling
Can methadone be dispensed for opioid dependence?
Only for pain. Same with buprenorphine/naloxone
How can a CII not be written on a controlled Rx?
Only for terminal ill Must write "11159.2 exemption"
When can a CII be FAXED?
Only if it is for a long-term care facility or a hospice
Faxed CII
Only if pt in SNF, intermediate care facility, home health, or hospice
Can a retired prescriber prescribe?
Only if they have a voluntary service license
PRN refills allowed on what?
Only non-controlled.
What are the restrictions on buying prescription EC?
Only valid if prescription is written for a woman
DEA Form 222
Ordering C-I and C-II substances
DEA 222
Ordering Schedule 1 & 2 Drugs
DEA form 222
Ordering Schedule I and II Drugs /pharmacy keeps copy 3 and sends copies 1&2 to the supplier/
Form 222
Ordering and transferring of Controls
What is a DEA 222 used for?
Ordering, transferring, AND returning CII's
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
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
What personnels can communicate the transfer of Rx?
Pharmacist or pharmacist interns
Flagyl
Photosensitivity Discoloration Do not refrigerate Protect from light
Tetracyclines
Photosensitivity May make birth control less effective Protect from light (doxycycline)
Legitimate DEA
Practitioner: 1st letter is A or B. Mid level practitioner: 1st letter is M. Second letter = usually 1st initial of provider's last name. Step 1: Add 1st, 3rd, & 5th number Step 2: Add 2nd, 4th, & 6th number Step 3: Multiply the sum from step 2 by 2 Step 4: Add the sum of step 1 & 2 (Then, the ones digit of this sum must be the same as the last digit of the DEA number)
Which diabetes meds can be at room temp for 30 days?
Pramlintide (Symlin) Byetta Victoza
Who can phone in prescriptions?
Prescriber or any designated employee. Name of person transmitting Rx must be documented.
Who can transfer rx?
RPh and intern
Who can receive a phone Rx?
RPh and interns
If RPh license is not renewed in 3 years following license renewal....
RPh will have to retake and pass licensing exams.
Class I recall
Recall class where there is a reasonable possibility that the use/exposure to a violative product will cause *serious adverse effects on health or death*
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
What is NOT traditional compounding...
Reconstituting according to manufacturer Splitting tablets Adding flavor
DEA 41
Record of Controlled Substances Destroyed
DEA form 41
Record of Controlled Substances Destroyed
DEA Form 41
Record of controlled substances destroyed
Regulation status for ulipristal (Ella)
Rx only
What do need to do before filing an Rx?
Rx# Date of fill Rph initial if filled by tech/intern
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*
Maximum volume for SC and IM injections
SC - 2 mL IM - 5 mL
Interim period for a temporary pharmacist-in-charge
Shall not exceed 120 days (4 months)
What is the red container for?
Sharps
What parts of a prescription MUST the prescriber physically write?
Signature and issue date
When can you have a controlled substance hold-over for no refills?
Small reasonable supply NEVER FOR A C-II
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
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 #
Steps to verify a DEA number
Step one: Add the 1st, 3rd and 5th digits together Step two: Add the 2nd, 4th and 6th digits together Step three: Multiply the result of step two by 2 Step four: Add the results of Step 1 and 3 together, the last digit of the sum should match the last digit of the prescriber's DEA number
Examples of CIII's
Testosterone (Androgel) Buprenorphines Buprenorhpines with naloxone Ketamine (Ketalar) Perampanel (Fycompa) Fiorinal +/- codeine
Drugs with REMS
Thalidomide Isotretinoin Clozapine Qsymia Long Acting Opiates (MS Contin, Oxycontin, etc) Saxenda Forteo
Medications with REMS requirements
Thalidomine Isotretinoin Clozapine Qsymia Symlin Saxenda Forteo Addyi
Class II recall
The *probability of serious harm is not likely* and the effects may be *temporary or reversible*. This recall does not go to the customer level and is usually due to problems with *consistency of potency*
Ryan Haight Act (2008)
The Act requires any practitioner issuing a prescription for a controlled substance to conduct an in-person medical evaluation at least once every 24 months.
Filter
Simponi Lipids Ativan Amiodarone Amphotericin B PN Dilantin (SLAAAPD)
A pharmacy may order CII from out-of-state wholesaler, manufacturer, or other supplier as long as pharmacy forwards a true & correct copy of the order, contract, or agreement for procurement of such a CII drug to who & within what time period
State's Attorney General's office within 24 hours of transmitting order
Max injectable volumes
SubQ: 2 mL IM: 5 mL
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
optomietrist license ends with?
T
Who can take a non-controlled refill over the phone?
Technicians or CLERKS
5th gen cephs
Teflaro
Telepharmacy - remote site can: 1. Accept delivery of meds (CS must be stored until RPh can review and countersign) MUST use barcode technology
Telepharamcy CANNOT: 1. accept new rx orally, compound, perform any task requiring professional judgment .
What do you have to do if you lose a prescription pad for controlleds?
Tell LAW ENFORCEMENT Notify the DOJ and their CURES program Notify BOP Notify Medical Board by letter or email
CS auxillary label
The federal warning label prohibiting transfer of CS must be placed on the prescription container. This statement is not required to appear on the label of a CS dispensed in clinical investigations which are "blinded"
Every electronic transmission of a prescription needs the name of..
The transmitter on the transmission
How long does someone have to enroll for Medicare?
They have 7 month period 3 months before the turn 65 The month they turn 65 3 months after the month they turned 65
How can a PIC be in charge of two pharmacies?
They have to be 50 miles apart
What are required for multiple pre-printed prescriptions (like from the optometrist)?
They have to be non-controlled. Number of meds have to be indicated on the bottom
What is a requirement of all MediCaid/ MediCal prescriptions?
They must ALL be on controlled pads. Yes, even OTC This doesn't apply to phoned, faxed, or e-prescribed
How can a for-profit pharmacy buy stock from a non-profit pharmacy?
This is only for emergency situations. They have to return the bottle after they're done. They cannot buy LARGE quantities. They can still sell at their usual price though.
For a prescription for Zaleplon (Sonata) 10 mg QHS #30 with 5 refills, is the patients entitled to five refills within 6 months?
This prescription cannot be refilled five times; it can only have filled 4 times, which would be 120 days.
What happens with TRIPLICATE 222 form
Top copy (brown): supplier Middle (green): DEA Bottom (blue): pharmacy "BS! GD, my Bl(ood) Pressure"
Disposal of controlled substances
Transfer to DEA registered reverse distributor (contact local DEA for listings). Reverse distributor needs to issue a Form 222. Reverse distributor should issue form 41 for the destruction of controlled substances
Fax of RX from one pharmacy to another pharmacy
Treat fax like telephonic order. Create a written RX identify it as a transferred RX & attach faxed copy as reference
Must all CII-CV be written on a security precription form? T or F.
True.
All chemo are made in ____________.
Vertical flow hood
What is a security requirement for technicians signing for controlled substances?
Video taped and kept for 4 months (120 days)
Refrigerated eyedrops
Viroptic Zioptan Xalatan
How often do you have to report to CURES?
WEEKLY
When can techs take in an Rx?
When it is a refill NOT requiring changes
When can the board void a pharmacy permit?
When the pharmacy is not engaged in ordinary activity for which a license has been issued for at least one day each week during any 120 day period (last 4 months). Any objections must be received by the board within 10 days.
Can EC be furnished for future use?
Yes, there is no product quantity limits
What if the patient wants the label printing in their language?
You can do it BUT!!! you have to have English version also on the label
Consumer Medication Information
With each NEW Rx Not reviewed by FDA, basic information on how to use the drug and what to expect
What to do with hard copy once controlled C3 is transferred?
Write VOID on face. Name of receiving pharmacy on back. Write "transfer" on receiving end.
When transferring controlled Rx which dates are needed?
Written date, fill date, last fill and transfer date. (written date is not needed for non-sched)
What are exemptions for non-security pads that you can have for controlled substances?
YOU CANNOT EXEMPT CIII-CV You can exempt 11159.2 exemption for C-II drugs only
Compounding license renewal?
Yearly
How often does a pharmacy must renew their sterile compounding license?
Yearly
Pharmacy permit renewal?
Yearly
Can a prescription contain orders for non-controlled and controlled substances on the same paper?
Yes, but needs to be on the CA Security Form for CS
Can Rph change formulation of drug (with same API of equiv strenght/duration)?
Yes, if it will improve patient compliance
Can there be online controlled drug pharmacies?
Yup Register with DEA
When the pharmacy distributes CS to a DEA registrant
a DEA form 222 is prepared by the purchasing registrant and provided to the pharmacy selling the CS
a pharmacist can dispense ephienphrine auto injectors to?
a first responder or lay rescuer who is trained and qualified school district or charter school
two pill levonorgestrel: behind the counter:
age: atleast 17 years old no gender restriction
Amytal generic and schedule
amobarbital - CII Amobarbital, pentobarbital, and secobarbital are schedule II barbiturates.
What documentation should pharmacy A use to sell Provigil to pharmacy B?
an invoice (C-IV)
state of CA: pharmacists can dispense up to how much of a supply of self-admin hormonal contraceptives?
annual
Compounding P&P manual is reviewed by PIC how often?
annually
Sterile compounding: successfully completes practical skills training in aseptic technique and aseptic area practices. Continuing training is reassessed how often?
annually
when you have to report to the board hat you have a med take back program and location of the bins
annually
Who can purchase Rx Plan-B one step?
any female
Who can purchase Rx Plan-B?
any female
Who can purchase ulipristal?
any female
How many times can a non-scheduled drug Rx be transferred?
as many times as there are refills
Pharmacy A and Pharmacy B share a real-time, online-database of patients. How many times can a Rx of Marinol be transferred between Pharmacy A and B?
as many times as there are refills remaining (C-III)
how many times can non-controlled drugs be transferred
as many times as there are refills remaning
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
CLIA waived assessments
blood glucose hemoglobin A1c cholesterol
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
out-of-state prescription
can fill if license if equivalent to that required of a CA prescriber
Cancidas
caspofungin
Tagamet
cimetidine
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
when to complete self-assessment of pharmacy records
complete every odd year before july 1st
the originating pharmacy is responsible for?
counseling maintaining medication profiles performing drug utilization reviews
Record Requirements for dispensing drugs during a federal, state or local emergency
date, patient's name, patient's address, the name, strength and quantity of the dispensed drug or device
for schedule ii-v drugs: california pharmacies can fill and ___ ?
deliver the prescription back to the originating state
Rph, PharmD
dependent authority -all non-controlled, CII-V drugs
DEA form 41
destroyed controlled substances
counseling must include?
directions for use storage compliance precautions and relevant warnings
DEA for 224
dispense controlled substances
EC that you always need an RX for
ella
pharmacist is responsible for
ensuring safe and accurate dispensing of prescription DUE Counseling superfvising staff performing other patient care activities
period one must renew license to continue pharmacy practice
every 2 years. if not renewed within 3 years of expiration, it will not be renewable
Offer to counsel
only the pharmacist or intern can offer
Actiq generic and schedule
oral fentanyl - CII
dea form 222
ordering, distributing, transferring schedule i and ii drugs
Who is responsible for counseling on the medications that are filled at a refill pharmacy?
original retail pharmacy
LEft off
p. 125
emergency refill limit: non scheduled
partial or full refill, at the pharmacist's discretion
Nembutal generic and schedule
pentobarbital injection C-II
Aceon
perindopril
DATA 2000
permits PCPS to prescribe and dispense schedule III-V drugs to tx opioid addiction outside of a registered clinic these PCPS will have a UIN that is their DEA # with an X as the first letter instead of whatever it was before this is in addition to their DEA #
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
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*
How often is schedule II drug physical inventory be performed?
quarterly (every 3 months)
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
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
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
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
transaction statement (TS)
statement that the entity transferring ownership in a transaction is honest and accurate
DEA check
step 1: add 1st, 3rd, and 5th digits together step 2: add 2nd, 4th, 6th digits together step 3: multiple result of step 2 by 2 step 4: add step 1 and 3 together; last digit of this sum should match last digit of PCP's DEA number
partial shipment of a form 222
supply the balance within 60 days from the date the form 222 was executed
Controlled substance inventory
take every 2 years
Community setting pharmacist to technician ratio formula
tech= 2*(pharmacist)-1
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
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
People the pharmacist must inform about a medication error
the patient and the prescriber
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
True or false: a hospital *pharmacy tech* can package and seal the emergency supplies for use in the HCF.
false - needs to be RPh
med guides are?
fda approved patient handounts that come with many rx medicines that have a serious and significant public health concern
how many technicians permitted per pharmacist in community setting
for 1st pharmacist - 1 tech for each additional pharmacist - 2 techs
DEA controlled substances inventory record is kept?
for 3 years
emergency refills
for non controls, can give however much you think (can give whole refill) for controls (schedule III-Vs since IIs never have refills) - can only supply reasonable amount, usually like 2-3 days
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)
Foradil
formoterol
transaction history (TH)
has all the information that traces the drug from place to place, beginning when the drug leaves the MFG
hospital drug supply inventory
has to be done every 30 days if irregularities, must report within 24 hours to PIC and director of hospital
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.
dextromethorphan requirement
have to be >18 and show photo ID unlike psuedoephedrine, can be kept on shelves outside of the pharmacy
tech check tech program only in (hospital/community) setting
hospital only with clinical pharmacy program ; pharmacists located in the patient care areas
Tussionex generic and schedule
hydrocodone polistirex and chlorpheniramine - schedule II
when substitutions are allowed
if bioequivalent if PCP does not write do not sub AND HAS to be cheaper if generic is used MUST tell patient that it is cheaper as well
inventory rules:
if bottle unopened: exact count needed but you can go off what the bottle/manufacturer says for schedule I and II: EXACT COUNT ALWAYS for schedule III-Vs: if <1000 dosage units: estimate is ok if >1000 dosage units: exact count
Within how long of a significant controlled substance theft be reported to the DEA?
immediately (within 1 day)
When to report (call) potential child/elder abuse/neglect?
immediately to law enforcement.
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*
How frequent should controlled substance inventory be done?
initially and biennially
what can APPs do
initiate, adjust, D/C drug therapy in accordance to protocols
What form is used to distribute schedules III-V drugs between DEA registrants?
invoice
DEA form 106
loss/theft of controlled substances
PAPs
low-income, uninsured patients get free or low-cost BRAND NAME medications
DEA form 225
manufacture controlled substances
Pharmacy Z orders C-II drug from manufacturer A, who keeps DEA-222 copy 1?
manufacturer A
Max period for a temporary PIC
max 4mo
Desoxyn generic and schedule
methamphetamine tab schedule II
DEA first letter M
mid-level practioner (NP or PA)
Amount of time a hospital must keep all orders for controlled substances
minimum of seven years
Classes in CIII?
most mixed narcotics, codeine (<1.8g/100cc), dihydrocodeine (<300mg/100cc), opium (<500mg/100c), morphine (<50mg/100cc), mixed stimulants, barbitrurates, anabolic steroids (+growth hormones)
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
name tag requirements?
name license status 18 point type
Repackaging label requirements
name of drug strength dosage form manufacturer's name lot number expiration date quantity
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)
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
Envizo
narcan auto-injector
DEA 224
new registrant application are used to order initial DEA 222 forms
can you transfer C2s?
no
one pill levonorgestrel: prescription: age and gender restriction
no age restriction female only
Pharmacist to clerk ratio
no limit
max limit on pharmacy clerks per pharmacist
no limit on clerks
Refill limits for C-V drugs?
no limit within 6 months
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
definition of pharmacy being closed down
no longer engaged in activity it was licensed for, or not operating at least 1 day per week for a 120 day period
are CA pharmacies allowed to dispense Rxs written for C2s from out of state prescribers?
no! but for all other drugs (e.g. CIIIs-Vs) it is allowed as long as prescription meets requirements based on the STATE IT WAS WRITTEN IN
how many tech trainees can a pharmacist supervise
only 1 technician trainee at a time, fr up o 120 hours
can you transfer CIIIs-CVs
only allowed ONE transfer has to be down between 2 licensed pharmacists UNLESS they have a shared database; then they can transfer up to max refills the Rx has
for both community and hospital pharmacies, drug delivery is
only delivered to the licensed premises signed for and received by a pharmacist
when it is ok to dispense from internet dr
only if PCP has done an appropriate exam
true or false: you always have to keep C2 Rxs separate
true
temporary permit issued upon transfer of ownership
up to 180 days
How long can CII be partially fill CII drugs
up to 30 days after issue date
time frame EC will work
up to 72-120 hours ella is more effective >72 hours vs. plan b
Within how many days must the DEA be notified of *controlled substance loss or theft*? What form?
upon discovery (within 1 business day) DEA Form 106
if you choose to file your schedule III-Vs rx with non controlled Rxs you need to do this
use a red "c" stamp at least 1 inch high to label each control Rx
ordering schedule iii-V drugs
wholesaler or distributor's ordering system CSOS
Amount of time a pharmacy must investigate a medication error
within 2 business days
Centralized hospital packaging pharmacy - can provide unit dose mediations to *one or more* acute care hospitals under common ownership and located....
within 75 miles. Unit dose must be barcoded!
Dr. B calls the pharmacy to authorize an emergency fill of Kadian. If the written Rx is not received within the specified period, when should the pharmacy report to the California Bureau of Narcotic Enforcement?
withint 144 hours
a substitution cannot be made if the prescriber
writes or verbally says "DNS checks off the box initials the box
renewal time period on pharmacy permit
yearly
renewal time period on sterile compounding license
yearly
Can physician issue multiple prescriptions for schedule II drugs in a single office visit?
yes
can pharmacists give out hypodermic needles and syringes
yes
Can use buprenorphine and methadone with Benzos?
yes - but caution for CNS depression
Sonata
zaleplon
What schedule is ketamine
CIII both in California & federally
Human chorionic gonadotropin schedule
CIII in california
What form is for disposal of controlled substances?
DEA form 41
Which flushes down toilet?
Duragesic patch (ER), daytrana TD, Diastat/Diastat AcuDial
Purchase invoices for all rx drugs.
Maintained x 3 years.
Maximum trainee hours
Max 120 outpatient Max 200 hours inpatient
Temp PIC permit
Max 4 months
4th gen cephs
Maxipime
Faxed RX
May accept as original RX if sent by MD, PA, NP, CNM, & ND for nonscheduled & CIII, IV, & V. If faxed by patient, need original or call MD to take telephone order. Require initials of sender
Naturopathic doctors
May independently write for or furnish natural or synthetic hormones W/O physician directed protocol IF natural or synthetic drug is NOT controlled substance like testosterone (CIII). To prescribe testosterone need supervising MD & DEA license
What is the one priviledge the intern pharmacist may not have?
May not hold the key to the pharmacy
Non-PVC containers
Tacrolimus Insulin NTG Ativan Amiodarone
Medi-Cal outpatient drug prescription must have the following to be reimbursable.
Tamper-resistant pads - void appears if photocopied or has watermarks - quantity and refill check off boxes - "Rx is void if more than __ Rxs on paper" - serially numbered California security form for controlled substances exceeds requirements and can also be used
Who can stock ADDS in a COMMUNITY setting?
Technician and up under supervision
Which drug requires package insert with every Rx
Estrogen
Which DEA form allows for registration of retail pharmacies, hospitals, practioners, teaching institutions and mid-level practitioners?
DEA 224
Record documenting return of drugs to wholesaler or mfg (retained for how long?)
Maintained x 3 years.
Record documenting transfers or sales to other pharmacies, licensees, and prescribers.
Maintained x 3 years.
Self-assessment forms.
Maintained x 3 years.
Certificate of completion for CE.
Maintained x 4 years
Patient acknowledgment of HIPAA.
Maintained x 6 years.
Can prescriber dispense multiple CII at different dates?
Yes. as long as date written is true date written.
When using terminally ill as exception for anything, prescriber needs to write what on rx?
"11159.2 exception"
Dr. B calls the pharmacy to authorize an emergency fill of Kadian. You receive the written Rx from Dr. B; what information should be on the written Rx for it to be considered valid?
"Authorization for Emergency Dispensing", date of oral order
Vinka alkaloids will be labeled with_________.
"FOR INTRAVENOUS USE ONLY" Giving it INTRATHECAL may cause death
Max amount that may be charged as an administrative fee in addition to the cost of an emergency contraceptive agent pursuant to protocol (no admin fee may be charged if rx)
$10
max amount that may be charge as fee in addition to cost of an emergency contraceptive agent
$10
If pharmacist is involved in a lawsuit, beginning at what settlement dollar amount must it be reported to BOP
$3,000
Time period a schedule III or IV prescription must be filled or refilled before it is void
-Expires 6 months from date the prescription was written. -Refills shall not exceed 120 days supply of medication in 6 mo period -Refills shall NOT exceed 5 times in a 6 month period
All new rx must be counseled on by a pharmacist. Exceptions, if a patient is in (3)
-a healthcare facility -an adult care facility -juvenile detention facility
What are Security Forms required for? (2)
-all CS -all Medi-Cali outpatient prescriptions (including OTC, non-controlled, and CS)
How often do physicians need to look at CURES? (2)
-before prescribing a controlled substance for the 1st time - And once every 4 mo if rx is still active
What additional services does SB493 provide to pharmacists?
1. Healthcare providership 2. Advanced Practice Pharmacist designation
EC can be obtained by 3 options
1. OTC 2. Rx 3. Furnished by a CA pharmacist under the board's EC protocol
What are common first letters for normal prescriber DEA's?
A B F G
CSOS Certificates
A CSOS certificate is the digital equivalent of the identification information contained on a DEA form 222. CSOS certificates are issued to individuals and are required for electronic ordering of Schedule 1-2 CS.
Disposal form for controls?
DEA Form 41. 3 copies
Condoms
A pharmacist can provide up to 12 condoms under Medi-Cal and Family PACT for each client who obtains EC
Electronic transmission
A pharmacy or hospital may receive electronic data transmission of prescriptions or computer entry prescriptions for controlled substances: II, III, IV, V & nonscheduled
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
Retrospective DUR
A review of drug therapy after the drug is dispensed
What is REMS and who enforces it? Examples?
DEA enforced Ex: Androgel
DEA practitioner DEA
ABFG
DEA form reporting theft/loss
DEA form 106
orange book A and B
A- therapeutically equivalent B- not therapeutically equivalent
Orange Book designation
AB = therapeutically equivalent BB = NOT therapeutically equivalent
How often to inventory CII by Fed law?
Accurate. Exact. Every 2 years.
Master compounding formula
Active ingredients. Inactive ingredients. Process/procedures used. QA reviews at each step. Post-compounding process or procedures if any. Exp date requirements (not to exceed 6 mo or shortest exp date of any component of compounded drug)
Lost or stolen control form?
DEA form 106
Tech-check-tech program allowed location in California
Acute Care Hospitals with an _ongoing clinical_ pharmacy program
Where can tech check tech programs be used?
Acute hospitals with pharmacists located in the patient care areas
Tdap
Adacel, Boostrix
If DEA numbers start with X?
Addiction prescriber
CE requirements for advanced practice pharmacists
Additional 10 CE's Total = 40 CE's every 2 years
What must be reported to a P and T?
Adverse drug events in a hospital setting
When can non-controlled records be off-site
After 1 year
When can controlled records be off-site
After 2 years
When can a non-rph/intern recieve an order?
After hours or for a remote dispensing site pharmacy (tech can sign)
Notice Requirement by board & response to notice by licensee
After notice, licensee must respond within 10 days
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
Examples of C IV's
All BZDs Sleeping aids Tramadol Phentermine Soma Modafinil Phenobarbital
Writing a CS Rx
All CS drugs: can type all or have someone else write it out, except signature and date must be written by prescriber. Must be filled w/in 6 months. Pharmacist can correct minor errors on script but can't fix the signature and date.
Which healthcare providers can prescribe and what are their furnishing authorities?
All INDEPENDENT authority: - Physician - Dentist - Podiatrist - Veterinarian - Optometrist (must have a T at the end of their license number and can ONLY prescribe a 3 day supply of codeine or hydrocodone products) - Naturopathic doctors (must have NDF preceding their license number) A. Can only furnish the following: i. Epinephrine ii. Natural or synthetic hormones iii. Vitamins, minerals, amino acids iv. Dependent authority: III-V drugs - Registered pharmacist i. Emergency contraception, self-administered contraception ii. Travel medicine iii. Nicotine replacement iv. Naloxone iv. Immunizations v. Dependent: II-V drugs DEPENDENT AUTHORITY: drugs II-V i. Certified nurse midwife ii. Nurse practitioner iii. Physician Assistant
What is the difference when filling a veterinarian label?
All as regular labels Additional: name of pet and species
What can clinics dispense?
All drugs including C3-C5. NOT CII
Intern pharmacist can do...
All functions of a pharmacist under supervision, but CANNOT have a key to the pharmacy
Administering Injectable Drugs and Biologics
All licensed pharmacists can administer drugs and biologics via injection
Secobarbital suppository schedule
Amobarbital, secobarbital, & pentobarbital suppositories = CIII. Tablet, oral liquid, cap, injectables of these agents = CII
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
Prospective DUR
An evaluation of a patient's medication profile prior to dispensing, performed by the dispensing pharmacist every time a prescription is filled
What DEA form is for controlled substance theft?
DEA form 106
How often to renew compounding license from BOP for community pharamcy?
Annually
How often is a hospital licensed renewed?
Annually before Nov 1
Any hospital that orders, stores, and dispenses drugs MUST have a permit issued by the board. When must it be renewed?
Annually or before November 1st
Disclosure to board of service and location of each take-back receptacle
Annually, at time of facility license renewal
Name class of meds with Med Gudies
Antiarrythmics, ADHD, antidepressants, antidiabetics, antipsychotics, LABA, sleep meds
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*
Pharmacists must disclose violation of what laws?
Any violation of law, except for traffic violations that do not involve alcohol and controlled substances
Who can you sell hypodermic needles to?
Anyone age 18 and older
Who can own pharmacy?
Anyone except MD (prescriber - 10%)
Who can own a pharmacy?
Anyone except a prescriber (cannot be an MD/DO,...)
How many clerks can 2 pharmacist have?
As many as possible.
If you are receiving a transfer for a control, what is very important to ask?
Ask when the first time they gave the medication Also get the DEA of the sending pharmacy
How long should patient medication profile records be kept
At least 1 year
Patient Medication Error Records
At least 1 year
Patient Medication Profile Record
At least 1 year
RPh can perform ___tests which are waived under CLIA (no CDPH registration reqd) (3)
BG A1C Cholesterol
Take with plenty of water
Bactrim Bisphosphonates Azulfidine (+ food)
Name Schedule IV drugs
Benzodiazepines Temazepam Barbiturates (Long acting) Provigil Difenoxin Dextropropoxyphene
Rx transfers
Between two pharmacists or interns Include - name of pharmacists/interns involved - name of pharmacy, address or store number - original date and dispensing date - original number of refills - number of refills remaining that have not dispensed
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)
When are hospital outpatient, community and compounding self-assessment forms due?
Biennial; July 1st of each odd numbered year i.e. 2015, 2017
CI in CrCl < 30
Bisphosphonates Avanafil Arixtra NSAIDs K-sparing diuretics Tramadol ER Xarelto Pradaxa Cialis Cymbalta (BAANK TX PCC)
Nicotine products go in which waste?
Black bin.
Chlorohydrate goes in which waste?
Black waste
Bulk chemo waste goes in which bin?
Black. Trace for yellow.
CLIA (Clinical Laboratory Improvement Amendments) - waived tests
Blood glucose, A1C, cholesterol Meaning no registration is required to perform these tests
Which DEA 222 to give to supplier?
Brown DEA 222 (TOP)
Subutex
Buprenorphine (CS 3) Used for opioid addiction, Sublingual tablet, In a different brand name as a patch and injection.
Fioricet
Butalbital 50 mg (controlled), caffeine 40 mg, APAP 300 mg
NP prescribing drugs
CII-V allowed
Traditional compounding regulated by
CA BOP USP
Check for peanut or soy allergy
Combivent (not Respimat) Prometrium
Which Rx records kept 3 years?
Community, clinic, pharmacy (not hospital)
You are a PIC at a hospital that dispense medication for outpatient use, as well as compounding antibiotic creams. Which self-assessment form(s) should you complete?
Community/hospital outpatient, Hospital pharmacy, Compounding
Pharmacist to tech ratio
Community: 1:1, then 2 for each additional pharmacist Inpatient: 1:2
Acceptable amount of technicians per pharmacist
Community: 2n - 1 Hospital: 2n *n = number of pharmacists
DEA form that manufacturers, etc need to fill out to register with the DEA
DEA form 225
Case of Norco damaged. Who and when to contact?
DEA within 30 days for controlled substances
DEA FORM 41
DISPOSAL OF CONTROLS
What are the requirements of consultation?
Directions Importance of compliance Proper Side effects Drug interactions
Rule of thumb for gowning?
Dirty to clean. Boots to head.
DAW 1?
Dispense as written per MD. Needs to initial checkbox.
Form 41
Disposal of Controls
Auxiliary label if dangerous in combo with alcohol
Disulfiram MAO-I Nitrates Cycloserine Antidiabetic agents (hypoglycemia)
What is the correct way to ante-date?
Do not dispense before... Main date has to be the day of
Lasix
Do not refrigerate Protect from light Photosensitivity
Dilantin
Do not refrigerate Saline Filter
TPN goes in which waste?
Down the sink.
Re-Using the Old Container
Each time a med is dispensed, it must be in a new container with this exception: The pharmacist must dispense and refill a Rx for a non-liquid oral product in a clean multiple-drug medication package if the patient's med pak is reused only for same patient; no more than a one month supply is dispensed at one time, and each patient's med pak bears an auxilliary label which reads "store in a cool dry place"
Types of Emergency Contraception
Ella = ulipristal Plan B = levonorgestrel
When is the only time a pharmacy can get samples to dispense?
Emergency situations such as drug shortages
Which injectable is recommended to rub or massage to improve absorption?
EpiPen
What can a ND independently prescribe?
Epinephrine - synthetic hormones NOT TESTOSTERONE THOUGH
When can you estimate CIII-CV count?
Estimate if UNDER 1000 tabs
How often to inventory C3-C5 by Fed law?
Estimate unless >1000 units. Then exact.
Who does an outsourcing pharmacy register with?
FDA
What is the consumer reporting form vs professional reporting form for adverse reactions?
FDA 3500B for consumers FDA 3500 for health professionals
outsourcing facilities must register with?
FDA and the CA board of pharmacy
Manufacturing regulated by
FDA cGMP
Outsourcing facilities regulated by
FDA cGMP and CA BOP USP
place to look if drugs are bioequivalent / can be substituted
FDA orange book can permit switch without telling dr unless its a different formulation(e.g. ER vs. IR) or combination drug products OR if PCP writes do not sub
What analysis to conduct prior to a drug is approved?
Failure Mode Effect Analysis (FMEA)
How long should patient medication error documentation (AKA quality assurance reports) records be kept?
For at least 1 year
OD
For codeine- or hydrocodone-containing products, can prescribe a max 3-day supply (license # T)
When can CII be faxed?
From hospice
How long do you have to complete a partially filled CII if the patient requests the smaller quantity?
Full Rx within 30 days
Which DEA 222 to give to DEA?
Green (middle)
What can you do with a cease and desist order?
Have to stop all compounding Effective for 30 days Can request a hearing within 15 days
What is the black container for?
Hazardous
Which laboratory tests can be ordered by pharmacists under waived CLIA?
Hgb A1c, blood cholesterol, blood glucose
What's the only pharmacist thing that an intern cannot do?
Hold the key to the pharmacy
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
Exception of CIV reporting?
If dispensed a <48 hr supply
Refusal to dispense requirements
If he or she has previously notified his or her employer in writing and written protocols are established to ensure that the patient has _timely access_ to the prescribed drug or device despite the pharmacist's refusal to dispense the prescription or order
When can a small hospital (<=100 beds) dispense to outpatient?
If it needs to be started immediately and no access to the patient within 30 miles. 72 hours supply max
How long do you have to record a theft of control substance to the DEA?
Immediate (or 1 business day)
Bankruptcy must be reported to boarded within...
Immediately
Patient presents to pharmacy from out-of-state with empty labeled RX for digoxin that she's been on for 10 yrs. No refills remaining. Can pharmacist refill?
In best interest of patient to refill, but violation of law b/c pharmacy doesn't have record of medication. If pharmacist call out-of state pharmacy & request copy of RX then may fill emergency supply.
How many times can you transfer a non-control?
Infinite (up to refills)
How often can Non-Sched be transferred
Infinite. But controls are transferred 1X.
naloxone injection (p. 65)
Inject *1 mL* into upper arm or thigh muscle if no reaction in *3 minutes* inject another dose
Hospital pharmacy chart order records for controlled substances.
Maintained x 7 years.
What does a new PIC have to do
Inventory CII's within 30 days
Inventory requirement for controlled substances (CII-CV)
Inventory of controlled substances is required by federal law *every 2 years*! Accurate count for ALL C2s. Estimated count for CIII-V UNLESS....If the bottle of CIII-V is > 1000, then you need an exact count. Records must be maintained for 3 years in the pharmacy
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
Besides PSE, what else does the DEA regulate OTC that doesn't require an Rx?
Iodine 2.2% or greater (can make methamphetamines too)
How can you tell a license number is an optometrist?
It has a T at the end of the license number
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) need cGMP compliance?
Manufacturing, outsourcing facilities
CURES Program
Jan 1 2007 requires that CII, III, & IV be transmitted electronically to the central govt info data base on a weekly basis
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) are allowed interstate distribution?
Manufacturing, outsourcing facilities (no more than 5%)
What has to be pre-pprinted on a controlled substance multiple form?
Name, category of license, license number, DEA number
Sterile compounding pharmacies must receive accreditation from...
Joint Commission AND CA BOP
When are community pharmacy assessments done?
July 1st of every ODD numbered year
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
When can someone who is less than 65 get Medicare?
Kidney failure, kidney transplant, dialysis
Vet prescription requires
Kind of animal Name and address of owner
What is a Medicare Advantage plan
Known as Part C They must have Part A and B Ran by private companies
Does Medicare-B have Rx privileges?
LImited
DEA FORM 106
LOST/STOLEN CONTROLS
Selling Controlled Substances (p. 107)
Left off top of 107
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
Nonresident sterile compounding pharmacy requriements
License as a nonresident pharmacy with the BOP Have a license as a nonresident sterile compounding pharmacy with the BOP Reimburse the BOP for costs of inspections
Max number of patients for an X DEA prescriber?
Max 100 patients
PRN refills
Limit of one year
Form 106
Lost/stolen Controls
What is added to label for compounded Rx?
Lot number
What is an extra labelling requirement for compounded products or unit doses?
Lot number
What is an extra labelling requirement for compounded products?
Lot number
mid level practitioner DEA
M
Who has independent authority to prescribe C2-C5? (5 + 1)
MD DO Dentist (DDS) Podiatrist (DPM) Veternarian (DVM) Optometrist (OD) - can prescribe 3 days worth of tramadol-, codeine-, or hydrocodone-containing products.
Child-resistant caps
MD can waive for a single Rx at a time Patient can waive for all Rx
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
What is important to include on drugs in automated dispensing unit
Manufacturer and lot number included
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) need labeling with adequate direction for use?
Manufacturing
Manufacturing; Outsourcing facilities; Traditional Compounding. Which one(s) are regulated by FDA?
Manufacturing, outsourcing facilities
What are record requirements for compounded products?
Master formula record Name/strenght Date of prep Identity of personnel engaged in compounding Quantity of each ingredient Manufacturer, exp, and lot number of EACH component BUD Final quantity
Auxiliary label if it impairs ability to operate a vehicle
Muscle relaxants Anticholinergic agents that may impair vision Any of the following with CNS depressant effects: - Antipsychotics - Antidepressants - Antihistamines - Antinauseants - Anticonvulsants - Antihypertensive agents - Controlled substances
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
Emergency protocol (p. 58 on bottom)
Must be present if giving injections
Renewal time period on a *pharmacy permit*
Must be renewed *yearly*
Controlled substance refills by phone
Must be taken by pharmacist or intern. This is unlike CVS practice
Which profession cannot write for CII?
ND and optometrist
To furnish a prescription, a naturopathic doctor must have what in license...
NDF
naturopathic doctor license starts with?
NDF
DEA FORM 224
NEW APPLICATION FOR PHARMACY
Donating meds for redistributyion (p. 123)
NO *controlled substances* can be donated
Can CII prescriptions be partially filled?
NO. The only exception is for a terminally ill patient at an inpatient skilled nursing facility. Terminally ill = less than 6 months to live. Prescription can be filled for "terminally ill" patient. CII must either be fully filled or partially filled within 60 days of issuance (instead of the 6 months). Incremental portions may be given multiple times up to the amount written for on Rx.
Tech check tech
NOT operational in every hospital or community pharmacy program. Can only occur in acute hospitals that have an ongoing clinical pharmacy program where pharmacists are in the patient care areas
What is required for NP to write controlled Rx?
NP DEA number
Can pharmacy sell controlled drugs to other pharmacies or prescribers?
NTE 5% of total # of controlled drugs per year
Can you write in physician's info on a CII RX?
No, it has to be pre-printed
Prescriptions from outside of region
Other states: yes, if prescriber has license equivalent to that of a California prescriber Other countries: no
What can;t you use otic drops in the eye?
Otic doesn't have to be sterile (Cipro HC is not sterile) Otic drops are more acidic than eye can take
Can out-of-state CII drugs be filled?
Out-of-state prescriptions for schedule II drugs can only be delivered back to the original state, the California pharmacy cannot dispensed (or hand over) the prescription directly to the patient.
Medicare Part B covers
Outpatient
How many technicians can 3 pharmacists have?
Outpatient: 5 total. PIC can have only 1. (1+2+2) Inpatient: 6 Techs.
If med error is find, what is first step
Patient and MD must be immediately notified. 48hr later evaluation and prevention measures. Incident report given to insurance company.
Prescription requires
Patient info - name - address Drug info - name - quantity - directions - date of issue - purpose of drug if requested by patient Prescriber info - name, address, telephone - license classification - DEA number if controlled - prescriber signature
Prescription containers must be labeled with...
Patient info - name Drug info - Rx number - name - strength - quantity - directions - expiration date - purpose of drug if written on Rx - description of drug - brand name equivalent if generic - manufacturer if generic Prescriber info - name - date of Rx Pharmacy info - name - address
What is DAW-2
Patient wants a brand name
Refrigerated antibiotic suspensions
Penicillin V Vantin (cefpodoxime) Ceftin (cefuroxime) Benzamycin Erythromycin/sulfisoxazole (Pediazole) Amoxicillin Keflex (PVC BEAK)
nifedipine ER brand?
Procardia XL
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
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*
Which Rx's are allowed in COMMUNITY ADDS (Automated drug delivery systems)
Refills only
What can leave the pharmacy when there is no RPh
Refills with no counseling needed
DEA 225
Registration Form for Manufacturers, Distrubuters, Researchers, Analytical Labs, Importers, Exporters
DEA 363
Registration Form for Narcotic Treatment Programs
DEA 224
Registration form for Retail Pharmacies, Hospitals/Clinics, Practitioners, Teaching Institution, Mid-level Practitioner
DEA Form 225
Registration form for manufacturers, distributors, researchers, importers, exporters Get DEA number
When can a non-pharmacist stock an automated DDS?
Removable pockets, cards, drawers, single dose containers
How to administer injectable naloxone
Remove cap from vial Insert needle through rubber with vial upside down Pull back 1 mL Inject 1 mL into upper arm or thigh muscle If no reaction in 3 MINUTES, give second dose
Who needs to initial a label?
Rph if a tech/inter filled it
Who can sign for recieved orders?
Rph/intern
When can a smaller pharmacy buy drugs to sell cheaper from another pharmacy?
Sales cannot exceed 1% of annual inventory
How to administer Evzio
Same as Auvi-Q Remove outer cap Inject through clothing on outer thigh Hear hiss and click sound during injection Hold for 5 seconds
DEA 222 requirement for one pharmacy to another
Same except the SENDING pharmacy is giving the top two forms, and they fill out the middle form and give it to the DEA
If compounding a high risk level medications, the pharmacist/tech's technique must be evaluated ____________.
Semiannually, or twice a year.
What is the procedure to document a medication error?
Start investigation within 48 hours of the date the medication error was discovered. In terms of records, it must be kept in the pharmacy at least 1 year from the date is was created. It must contain: - Date, location and participants in the QA review - Pertinent data and other info related to the med error - Findings and determinations - Recommended changes to pharmacy policy, procedure, systems or processes to avoid the error again
State Laws v.s. Federal Laws (p. 83)
State laws may ONLY be *MORE strict* than federal laws canNOT be weaker
Requirements of mobile pharmacy
State of emergency Common ownership with licensed pharmacy Security measures Placed in a designated emergency area Cease within 48 hour of emergency ending
CI in CrCl < 50
Stribild Vfend
Who can sign the DEA Form 222 and CSOS? 1. All pharmacists 2. The person granted power of attorney 3. The person who signed the DEA Form 224 4. The person who signed the DEA Form 106
The Form 222 must be signed and dated by the person authorized to sign the DEA registration application or a person who has been granted power of attorney.
Can you fill benzo without prescriber authorization?
Yes. Use ProJudg. Tell MD "hold-over" supply to pt. Record on Rx. New bottle.
Can MD write for family member?
Yes. Within scope of practice.
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)
What ahs to be on a prescription of a protocol prescriber?
The information of the supervising physician
Which pseudoephedrine sale does not require documentation into a logbook?
The purchase of a single dose package of pseudoephedrine that contains a maximum of 60 mg does not need to be documented.
When does a pharmacist's license expire?
The last day of the pharmacist's birth month
A prescription must have:
The name of the patient The address of the patient The name and quantity of the drug or device prescribed The directions for use The date of issue Prescriber information (name, address, telephone number, license classification and DEA number if controlled substance is prescribed) Condition or purpose of prescribed drug, if requested by patient Prescriber's signature
For single entry security forms, what must prescriber write?
The prescription in prescriber's handwriting including DATE and SIGNATURE
When can you not give a discount card?
There is a lower price alternative (generic) to the brand which is covered by insurance
TCT program allowed when...
There is ongoing clinical pharmacy program, which has pharmacists located in the patient care areas
How often do you have to log the refrigerator temp?
Twice daily
Advanced practice pharmacist requirement
Two of the following: Certification in relevant practice area PGY-1 residency with at least 50% direct patient care Collaborative practice care for at least 1 year
Where do we find Emergency Medicine Services ADDS (EMSADSS) and how are its rules different?
Typically in an ambulance Medical director or designated paramedic can also restock
How young does a minor have to be to lose confidentiality?
Under 15 y/o and parent pays for healthcare
Time period in which to electronically send in info on schedule II, III, & IV rxs per the CURES program
Under CURES (Controlled Substance Utilization Review and Evaluation System) program must be sent weekly. If 48 hours supply of C2-3, monthly. if 48 hour supply of C4, no need.
What can a naturopathic doctor prescribe?
Under PROTOCOL CIII-CV CANNOT prescribe CII's
What is tech-check-tech?
Unit dose that have been reviewed by pharmacists already. Random audits are necessary
Sonata 10mg QHS #30 with 5 refills. Can you fill it?
Up to 120 days (180 pills requested)
how long can CII be partially filled at LTCF?
Up to 60 days for LTCF
What if an emergency supply is needed from an ADDS?
Up to 72 hours allowed
DEA 222
Use anytime a CII is ordered, transferred, and returned. Each book has 7 forms. Max of 6 books supplied at a time. 1st copy is wholesaler, 2nd is DEA, 3rd = pharmacy. Loss of forms must be immediately reported to DEA providing serial numbers 3 copies of DEA 222 form: - Top Copy (brown) - retained by supplier - Middle copy (green) - send by supplier to DEA - Bottom copy (blue) -retained at the pharmacy/recipient/receiver -Example: When order medications, I will keep the blue form and send the brown and green form to the supplier. The supplier (Ex. McKesson) will keep the brown form and send the green form to the DEA. 222 Forms are retained for 3 years
Use for DMSO?
Used for arthritis
How to measure RR
Watching and counting number of times patients chest rises and falls for 30 seconds
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
What needs to be done weekly as a pharmacist with controlled drug list?
Weekly reporting of CII-CIV to CURES program (DOJ)
White vs yellow for Epi-pen
White: second grade and below or 66lbs and below Yellow: thrid grade and above or 66lbs and above
Response to Notice sent by Board
Within 10 days
Upon closure of a pharmacy, a transfer of drugs notice must be provided to the board
Within 10 days of the closure, and must be in writing
Notify the board of any tampering with a collection bin (drug take-back)
Within 14 days
Notify the board of any theft of deposited drugs in drug take-back services
Within 14 days
Reporting Time Period? Theft by or impairment of a license
Within 14 days
When must a pharmacist report that another pharmacist was impaired at work?
Within 14 days
Notice to the Board of theft, diversion, self-use, impairment to practice by the PIC regarding a licensed employee
Within 14 days IMMEDIATELY TO DEA
How often to complete? Medication error investigation
Within 2 days of error
Changes in pharmacy ownership must be notified to BOP by when?
Within 30 days
Notify the board of d/c of drug take-back services
Within 30 days
Notify the board of establishment of drug take-back services
Within 30 days
Notice to the Board of LOSS of drugs (destruction/spillage)
Within 30 days IMMEDIATELY TO DEA FOR CONTROLS
ADDS registration requirement
Within 30 days Renewed ANNUALLY
How many days does a pharmacy have to register an ADDS?
Within 30 days of installation Also, must notify the board within 30 days if the pharmacy discontinues operating the system. -An exemption form registration is allowed for an ADDS operated by a licensed hospital pharmacy.
Notify CABOP of change of PIC.
Within 30 days.
Notify CABOP of change of pharmacist address or name.
Within 30 days.
Can a clerk touch medicine?
Yes, they can only put it away
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
A prescription for a mask has no expiration. Does a label still need an exp date?
Yes.
Can CIII-CV be phoned in from out of state?
Yes.
how long to keep patient med error documentation records
at least 1 year
how long you have to keep non controlled Rxs on site before you move them to a storage facility
at least 1 year
how long to keep patient med profile
at least 1 year from date of last entry
how long you have to keep controlled Rxs on site before you move them to a storage facility
at least 2 years
How often should hospital drug supply, floor stocks, be inspected?
at least monthly?
Hospital: when a pharmacy distributes C2 substances to another DEA registrant --> Copy 2 of Form 222 is submitted to DEA when?
at the end of each month
Patient's request for copy of medical records
be able to inspect records within 5 business days copies must be available within 15 business days
Patient DF presents today (3/5) with a Rx (written on 3/1) that for Tussionex ER 1 capsule every 12 hours as needed, #20. She doesn't want to pick up the entire quantity to avoid medication waste. She wants to pick up only 10 capsules today. When you perform the counseling, you should tell DF to pick up the remaining quantity on what day?
before 4/1 (within 30 days of issue date)
On what date should the self-assessment from be completed?
before 7/1 of odd years
Name some CIV?
benzos, sleep aids (most), phentermine, diethylpropion, modafinil, Soma
pseudoephedrine: max in a single transaction?
less than 60 mg (PSE) without needing to log the sale r show ID
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
Schedule form Vimpat
lacosamide is a CV
when does a pharmacist license expire
last day of pharmacist's birth month
interim period for temporary pharmacist in charge
not to exceed 120 days
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
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
Who may sign for receipt of prescription drugs delivered to pharmacy after pharmacy orders from wholesaler
pharmacist & pharmacy intern
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
CE credit
pharmacist must complete 30 hours of CE every 2 years. CE credits can be audited, don't fall behind
Who can perform hospital drug supply inspection?
pharmacists, interns, technicians
Pharmacy A transfer C-II drug to Pharmacy B, who keeps DEA-222 copy 3?
pharmacy B
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
EC that you have to be >17 to get
plan B 2 step
EC that be dispensed w/o age requirement or Rx
plan b 1 step
only absolute CI to furnishing NRT
pregnant! chest pain, a fib, heart attack, etc. are just relative CI, and can furnish w/ caution
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
Rapaflo
silodosin
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
"furnish"
to provide (sell, use rx insurance) without rx from MD
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*
Limitation for a pharmacy to sell controlled substance to another pharmacy
total number of dosage units is <5% of the total number of controlled substances dosage dispensed per calendar year
Medication error investigation
w/in 2 days of error
Syringe Sales
w/o a rx, syringes are limited to persons that the pharmacist knows need them such as insulin users or for animals. The sale of 10 or fewer hypodermic needles or syringes at any one time to a person 18 or older only if the pharmacy is registered in their local county or city w/ the Disease Prevention Demonstration Project, and complies w/ the requirements of that project. This is to reduce the spread of disease from IVDA.
Name some CV?
weak mix of codeine (<200mg/100cc) or opium (<100mg/100cc), lacosamide, pregabalin
How often should the controlled substance (CII-CIV) dispensing data (CURES) be submitted?
weekly
Reporting of filled C2-CIV prescriptions must be reported to cures on a ______ basis.
weekly
Sterile compounding: Exterior workbench surfaces and other hard surfaces in the designated area, such as walls, floors, ceilings, shelves, tables, and stools are disinfected how often?
weekly
can controls be delivered by USPS to a patient directly from a pharmacy?
yes but has to be hidden/not tell what's in it
can a pharmacy sell controls to another pharmacy?
yes but only if total amount does not exceed 5% of their sales have to forward copy 2 of DEA 222 form to DEA by end of the month
is partial filling of a schedule II allowed?
yes but time limits to pick up the whole quantity before! if pharmacy doesnt have enough in stock: 72 hrs partial fill of emergency oral Rx: 72 hours if pt or PCP request partial fill: 30 days if terminally ill/SNF: 60 days
are multiple Rxs for C-2s allowed?
yes only if they are filled sequentially, and provide up to a 90 day supply CANNOT pre or post date; must have true date written but can indicate a "do not fill until"
If the RPh feels it's best to omit info, can they?
yes, if they log it in pt record or a log for that purpose.
Can optometrist Rx oral abx?
yes. topical antivirals. refer to opthamalogist
