CPJE Flashcards - Davis

• conflict between federal and state statutes
• - federal always trumps state, unless state is more stringent

NO, they are guidances so you couldn't be criminally tried for not following the opinion, but can be civically tried d/t not following "standard of care"

• civil
• - usually between individuals, where money compensation is involved d/t individual being harmed/injured by pharmacist actions
• criminal
• - when law broken and government entity brings action
• - falls on infraction, misdemeanors, or felony classifications (usually misdemeanor)
• administrative
• - involves SBOP taking action against pharmacists license

• 13 members
• 11 appointed by governor
• 2 appointed by committee of state Senate and Speaker of Assembly
• 7 must be RPH with 5 in at least one of the following settings
• -acute care hospital
• -independent community pharmacy (pharmacist cannot own >4 pharmacies)
• -chain community pharmacy (75 or more pharmacies in Cali)
• -long-term healthcare or SNF
• -member of labor union representing pharmacists
• 6 non-pharmacists

• printed name, address, phone # of supervising prescriber
• printed/stamped name and license number of NP, CNM, PA
• signature of NP, CNM, PA

• for schedule III-IV meds - then if it exceeds 5 refills, 120 days of refills, or 6 months (whichever comes first) - then technically new rx and pharmacist or intern must take over call
• for schedule V meds - if exceeds 6 months or no more refills, then new rx and pharmacist or intern must take over call (CHECK)
• -

• 224 - registration form for retail rx, hospitals/clinics, practitioners, teaching institutions, mid-level practitioners
• 225 - registration form for manufacturers, distributors, researchers, analytical labs, import/exporters
• 363 - registration form for narcotic tx programs
• 222 - ordering schedule I and II drugs
• 106 - reporting theft or significant loss of CS
• 41 - record of CS destroyed

• Copy 1 = brown (always goes to whoever sends the drugs)
• Copy 2 = green (always goes to the DEA from the person who sends the drugs)
• Copy 3 = blue (always goes to whoever gets the drugs)
• brown --> green --> blue
• (how the water from the mountain flows down to the ocean)

• BOTH parties involved
• record - item transacted, date, name of drug, strength, amount, who made transaction, and if lent/borrowed/sold/bought
• keep records for 3 years

72 hours to SBOP

• 30 days
• side note:
• - fires can result in smoke, ashes, or moisture... if drug package exposed, then its adulterated and must be reported to SBOP and DEA (if scheduled)

YES, but make sure it only goes to designated parties (DUH)

• - give current retail price for any drug sold at rx upon walk-in request of consumer
• - if request for rx prices of >5 drugs, can charge reasonable fee as long as I tell them that
• - not required to give price quotes for >3 requests for 5 or more rx drugs from any one person or entity in 6 month period
• NOT REQUIRED
• - not obligated to provide drug prices if coming from person out of state
• - no need provide price for CS rx if request via telephone
• - not required to give price to competitor
• - you must display somewhere in pharmacy that's readable by consumer:
• - that price info is available

• 10%
• if hospital or non-profit or HMO's --> can be exclusively owned by physicians

• physician
• surgeon
• osteopathic medicine
• optometry
• naturopathic medicine
• dentistry
• veterinary medicine
• podiatry
• psychiatry (not psychologist)

not in best interest of the pt

non-profit can be sold to non-profit if sold to a walk-in customer and the sales are <1% of drugs purchased by the seller AND if emergency situation where no other soruces are readily available to meet emergency need

reasonable area sufficient to accommodate for safe and efficient performance of rx-related activities

• date, name, address of pt
• name, strength, quantity of drug
• prescribers name, address, phone number
• no need reason, but should be documented

the central fill pharmacies, don't use other pharmacy's inventory that originally received the prescription

YES

YES

• - schedules II-IV reported weekly
• - schedules II-III reported monthly if 48 hour or less rx
• - schedule IV not reported if 48 hour or less rx

NO, not in California

• not enough to offer to consult b/c pt can refuse/accept
• - must orally consult pt unless hospital discharge med
• - therefore cannot just provide written information, needs ORAL CONSULT
• if pt not present (aka MAIL ORDER or DELIVERY) --> responsibility shifted to pt to request consult... so pharmacist DOES NOT HAVE TO call pt, but they should receive a written notice of right to request consultation, and telephone number to call for consult
• if hospital discharge, person other than pharmacist can provide pt consulting

• if written by out of state prescriber, if non-scheduled drug then treated as if written by Cali prescriber. aka can dispense rx directly to pt
• if CS (II-V) issued by out-of-state prescriber, can be filled and DELIVERED/MAILED to pt as long as the rx meets the requirements for CS rx's of the state where it's written
• - helps accommodate pts who use out-of-state mail order pharmacies
• cannot dispense C-II rx's to pt if written from out-of-state prescriber (only can deliver)
• can dispense C-III through V DIRECTLY to pt if written on california security form or if orally authorized

TRUE

• directions for use
• directions for STORAGE
• importance of compliance
• precautions and relevant warnings
• side effects or interactions

within 10 days

• NO, illegal. only can change if it would benefit the pt aka can't swallow so put tablet/capsule into suspension form
• can't just change it b/c you're OOS

must have name/initials of person sending it (prescriber or his/her designee) AND assurances that med was ordered as result of good faith exam by prescriber

need type of animal, name of owner and address of owner on prescription

YES

TRUE

TRUE, but no waiver to sign to prevent this exists

• 120 day supply (doesn't include first fill)
• 5 refills max
• 6 month period (for C-II's too, but don't have refills allowed)
• MAKE SURE YOU NOTE THE DAY SUPPLY! not just the total days since rx filled (which is max 6 months)

YES

YES

YES

YES, must be partial filled within 60 days from the date rx written m

• YES (aka reasonable quantity)
• - make sure to label with name/amount of each ingredient, total weight/volume, appropriate expiration date, and "Prescriber's Office Use"

terminally ill pts getting C-II rx's on regular rx blanks

• must have the TPA designation
• - variety of PO abx
• - 3 day supply or PO codeine or hydrocodone when mixed with non-scheduled drug
• - topical anti-inflammatory (including steroids)
• - topical anti-glaucoma
• - topical antivirals
• - PO acyclovir
• NOT IM or IV abx

within 30 days

something within the pharmacy must be corrected within a given time

• YES...but only for Plan B... (plan B one-step has no age restriction OTC)
• - can give the 2 tablets at same time
• can charge up to $10 admin fee for services rendered in addition to retail cost of EC drug if dispensed as RX (if OTC, no admin fee can be charged)
• if providing EC under protocol (aka pt has no rx from prescriber, but wishes to use insurance) requires one hour of CE on emergency contraception... if OTC, no CE required
• if OTC (aka plan B or plan B one-step), no counseling required, if under protocol, counseling required
• only one drug ingredient exists under Plan B (2 tabs of levonorgestrel 0.75mg each) - must be 17 years old

• YES:
• -must register with Medical Board of Cali at time of initial app of license
• -rx must contain state license # of prescribing practitioner before filling
• -expiration date on label must state no more than 1 year from date of last prescribing exam
• -no generic substitution
• -must provide pt with following notice:
• "warning - if you have any unexplained eye discomfort, watering, vision change, or redness, remove lenses immediately and consult with eye doc"

• YES...
• C-II's cannot be refilled
• C-III through V must have designated amount of refills on rx

must communicate with pt that its saving money and ask for permission to dispense generic

within 30 days

caution, federal law restricts this drug to use by or on the order of a licensed veterinarian

• multi can dispense whatever amount called for on rx
• surgical can only dispense an amount no more than 72 hour pt need

• 3 years (YES)
• but... if license retired... then cannot be reinstated to active license... need to retake licensing exams
• - retired doesn't mean inactive... if inactive, then can reinstate before 3 years is up

YES, if readily retrievable in receiving rx

• YES, if in your judgment it would interfere with ongoing care or adverse effects could occur.
• you could just give 3 day supply, but you can also give the same amount as the previous refill

immediately

• pharmacist can require a written statement of request but must respond within a reasonable time (10 days)
• - may charge reasonable fee for each quotation, even though requesting customer doesn't get the rx's filled, as long as they know of this charge
• pharmacy not required to respond to more than 3 requests of this type from any person within a six month period
• can't add the price quote to the regular charge of getting rx filled

• must be physician in charge, but doesn't need to be present
• protocol that outlines who gets or doesn't get immunizations, and action if injury occurs
• physician doesn't need to provide rx for each individual who qualifies for immunization
• - notify PCP in 30 days
• - vaccination reported to state/local immunization information system in 30 days (tell pt you did this)
• - pt must be 3 years or older
• National Vaccine Injury Compensation Program - only protected from adverse reactions

• don't need to report to SBOP
• names of personnel involved don't need to be on report
• no need do med error report if it was corrected before getting to pt
• do investigation within 2 business days
• hold onto med error report for at least 1 year

EXCEPTION - can work 8 hours/day and 40 hrs/week at one rx, and work full-time or part-time at another pharmacy independently owned/operated relative to first rx

NO, removed by FDA

• waiver from SBOP, NOT license
• provide requested records to SBOP from storage site within 2 business days

180 days... if pharmacy sold to new owner

• YES, IF:
• labeling necessary part of clinical/investigational study approved by FDA
• OR
• in medical judgment of prescriber, labeling is appropriate for proper treatment of pt (aka placebo in place of actual drug)
• retain record stating the manner in which info on rx label varies from actual drug in container and documenting order of the prescriber to label the container in that manner. RETAIN FOR 3 years

• consultant pharmacist at least (must provide written reports/recommendations of pharmacy services at least quarterly)
• you can dispense drugs without full-time pharmacist if:
• - inpatients being discharged
• - emergency cases under tx by hospital
• - dispensing directly by physician to outpatients IF:
• - physician determines immediate use is warranted
• - physician believes no other rx available/accessible within 30 mins or 30 mile radius of hospital
• - no more than 72 hr supply of drug
• - properly label and dispense directly by prescriber
• can't just dispense drugs for outpt use pursuant to physician's rx... needs requirements

10 days... once transfer completed, notify SBOP immediately in writing

forward true and correct copy of order, contract, or agreement for procurement of such C-II drugs to attorney general's office WITHIN 24 hour of transmitting order

just talk to prescriber, document you talked to them about the error/omission

6 years

YES

LOOKUP

• 120 days
• you need application for proposed replacement PIC.... if denied, must propose another in 15 days and continue to do so until PIC approved... if unable to identify replacement in 30 days, can propose any pharmacist to act as the interim or temporary PIC for 120 days

• 3.6 g per day, 3 packages per day, 9 grams per month, 18 years or older, LOGBOOK
• no need logbook for 60mg pseudoephedrine purchases

NO, a required manufacturer label

• NTG SL
• isosorbide dinitrate SL or chewable 10mg or less

2.2 to 7.7 degrees celsius

• take rx's brought into pharmacy
• answer non-prescriber phone calls
• type labels
• put drug back into rx drug stock (after fill)
• CANNOT TAKE DRUGS OFF SHELVES to fill rx's

• licensed person in pharmacy (pharmacist, intern, tech)
• NOT CLERK...
• just report in 30 days that drugs were stolen... can fire and notify police of course

guam, virgin islands, puerto rico, american samoa

if not engaged in ordinary activity for at least one day each calendar week during any 120 day period

4 years

• both community and hospital must have separate license for sterile compounding
• renewable yearly subject to annual inspection by SBOP
• nonsterile compounding = NO SEPARATE LICENSE REQUIREDf

• III-V and NOT for C-II addictions
• physician must be certified to prescribe the drug

1 year

a pharmacy... with license from SBOP

ONLY for accessing information for the care of his/her pts

• any hospital owned by same owners
• must be located within 75 miles of each other
• must have barcoding to be used for checking accuracy of med admin at pt's bedside

• emergency/disaster response
• pt consultation
• maintaining control of rx's drug inventory
• ethics
• substance abuse, (indications of red flags and pharmacists' responsibility)
• compounding

• cannot sell, purchase, or trade or offer to sell, purchase or trade any drug sample
• if provided drug sample by licensed prescriber, you could dispense pursuant to order by authorized prescriber to pt at no cost (excess rules doe)
• - must have written/signed document that samples are to be provided to pts pursuant to rx
• - must be on official government form and have: practitioner's name, address, professional designation, name/strength of sample, number provided, name of manufacturer, and signature of practitioner

• what it was
• if low, normal, high
• advise to consult with physician if deemed necessary

• 12 point sans serif typeface
• 50% of label contains:
• - name of pt
• - name/strength of drug
• - directions for use
• - condition or purpose if indicated on rx
• suggested to be in bold or highlighted or color background to help

• NO... only pharmacist! (or pharmacist intern)
• the designated representative term is for wholesalers or veterinary food-animal drug operations (this person doesn't have to be a pharmacist)

• nonscheduled and CIII-V require log book to record transactions
• C-II's require DEA form 222

• independently prescribe:
• - epinephrine to treat anaphylaxis
• - nonscheduled natural/synthetic hormones (thyroid)
• if controlled substance, can do III-V only if getting DEA registration number and pursuant to physician authorized protocol

• must be:
• - life threatening condition with death potential HIGH
• OR
• - chronic and/or disabling condition that interferes with ADL's and condition may persist for years
• AND
• - reliable med lit supports use of drug for off-label purpose

• must notify PCP of naloxone furnishing OR enter info into pt record system shared with PCP
• if no PCP, provide written record of drugs furnished and advise pt to consult with PCP
• no prescriber protocol required
• 1 hr of board approved CE required
• naloxone only as IM or intranasal product
• CANNOT ADMINISTER
• can provide to caregiver of pt
• YOU MUST COUNSEL ON NALOXONE... pt cannot waive the counseling

• must not be more than 50 miles between the 2 pharmacies
• cannot serve as PIC of more than 2 pharmacies
• no pharmacist can be PIC of pharmacy as well as exemptee-in-charge of wholesaler or veterinary food-animal retailer

• pt must fill out questionnaire to decide whether pt candidate
• no need good faith exam by physician
• must notify PCP that furnished hormonal contraceptive
• can furnish PO, TD, VAG, or DEPOT injections in accordance with protocol approved by CALI SBOP and Medical Board of Cali

• PGY1 of accredited postgraduate institution with 50% of experience in direct pt care with interdisciplinary teams
• must have provided clinical services for at least one year under collaborative practice agreement with physician
• earned certification in relevant area of practice
• - ambulatory care, critical care, geriatrics, nuclear, nutrition support, oncology, pediatric, or ACPE recognized organization
• fellowship DOESN'T COUNT

• by July 1st of every odd numbered year
• kept at pharmacy for 3 years, not sent to SBOP
• if PIC change, must send in within 30 days to SBOP
• only done by PIC

• if award >$3000 of a claim or action for damages for death or personal injury caused by negligence, error, or omission in practice... by person who holds license...
• - must report within 30 days to SBOP

• 13
• 7 of which are licensed pharmacists
• 5 of which are actively engaged in pharmacy practice

• enforcing laws associated with pharmacy practice (disciplinary action
• conducting licensing exams
• investigating violations of law by Board licensed personnel
• adopt regulations that protect the consumer
• statute making is from the Cali State Legislature

DEA

• Cali SBOP responsible for licensing
• operator doesn't need to be pharmacist (they are exemptee in charge or EIC)... must be high-school graduate with one year of training in veterinary drugs
• renew license yearly
• if EIC resigns, report leaving within 30 days to SBOP

• then can use this as hard copy
• cannot fax schedule III-V from pharmacy to pharmacy
• - can fax C-III through V from prescriber to pharmacy (must reduce to hard copy... and potentially call)

• - must be authorized by federal law and regulations with DEA
• must be done under "e-prescribing" program

• no need logbook
• - can furnish without rx if person known and has previously gotten rx or other proof of legitimate medical need for the needle/syringe to administer med or treatment
• EXCEPTIONS:
• - if for animal use its OK
• - if for special declared disease prevention programs (AIDS, hep C prevention)
• (can give as much as you want)
• - must be 18 years old

• must be done at acute care hospitals that have ongoing clinical program where pharmacists are in pt care areas
• - still must be originally checked by pharmacist
• - must have P and P and specialized training by tech

• doesn't have to be pharmacist, but must be registered with DEA
• can be authorized under "power of attorney"

• C-II's must have ACCURATE COUNT
• - this is also done every 3 months and kept for 3 years
• C-III through V must have:
• - estimated count if <1000 bottle count
• - accurate count if bottle is 1000 or more and open

YES, not for controls because you need to know how often in order to calculate day supply and how long pt will be taking

pharmacy doesn't have to be open in order for pt to have access to ADDS device

YES. but if pt cannot remember or keeps calling, could be worth while to get a competent representative to also know this information

• 20 hours of specialized training of accredited travel med course
• must complete 2 hours of CE focused on travel medicine from approved provider in addition to the other 30 hours of CE required Q 2 years
• travel med regulation recently disapproved by office of admin law

separate... if admin law finds you innocent, board can still mess you up

MUST BE DONE

YES

• restrictions... no logbook on amount purchased
• betadine or povideon solution
• - iodine content cannot exceed 1% in containers of 8oz or less
• tincture of iodine
• - iodine content cannot exceed 2% in containers of 1oz or less
• WHEN SOLD OTC

• must have PIC, but doesn't always have to be there (can be other licensed pharmacist)
• must be close to destroyed pharmacy
• must not be operated for more than 48 hrs following restoration of permanent pharmacy
• 3 calendar days of restoration of pharmacy, tell SBOP