mpje WA1 Flashcards
Board
“10 members (must be licensed x10y in WA), 4 public members (no pharm), 1 tech 4 year terms, max 2 terms”
Rph responsibilities that may not be delegated
“Receipt of a verbal Rx, Consultation with pt, consult with Dr, extemporaneous compounding, interpretation of patient info, providing pt info, signing of docs, professional communication, decision not to dispense ultimate responsibility for Rx verification”
License fees
Original - 145, renewal 190, late renewal $100
Preceptors
Active practice x12mo, complete board-approved training q5y, can supervise more than 1 intern
Intern hours
1500h, 1200 from PharmD
Pharm assistants
“Typing, filing, refiling, bookkeeping, stocking, delivery NO data entry, no retrieval of drug to fill (can return)”
Pharm tech
“assist in manipulative, nondiscretionary functions under supervision of RPh 10h CE/y (1h law)”
Ratios
1 pharm : 3 techs : unlimited assistants
CE Req
“PharmD - 15h/y (ACPE-accredited) - register with NABP (not until y2) Tech - 10h/y (1h must be law)”
Pharmacy applications
“to PQAC 30d before meeting - 1 application + differential hours supp + ancillary personnel supp to DEA - form 224”
Pharmacy owner responsibility
Determine PIC, pay annual license, maintain rx records for 2y, CSA records for 2y
Requirements in pharmacy
Necessary equipment (vague), necessary references for RPh/pts / practitioners, current copy of WA Laws (online OK), one bottle of Ipecac, poison center phone #
Pharmacy grades
“A (90-100), Conditional (80-89) - 60d to improve - Unsatisfactory (<80) - 14d to improve 5+ pts off for violation of ancillary personnel rule –> auto unsatisfactory”
Med pack rules
Original bulk Rx container stays in pharmacy, max 31DS, patient must sign non CRC, same label as outpt Rx, WA Medicaid will pay
SNFs (ECFs)
Sig NOT required on label (?)
Unit dose rules
MUST have - Drug name, strength, lot number, expiration, CSA sc
OBRA-87
“Pharmacist involved in care, develops care plan, avoid duplicate rx, excessive, inadequate monitoring / use drug reviewed q30d by RPh”
Automated Drug Distribution Devices (ADDD)
“Requires approval from Board, must have designated RPh in charge, must get DEA# and registration if CS - Checking and stocking done by RPh, tech, or intern”
RPh responsivilities for ADDD
Quarterly audits, approve inventory, ensure security and training
Closing a Pharmacy
“Notification at least 15d prior, properly transfer custody of pharmacy’s records, where drugs will go - Notify pts >15d prior”
Wholesalers
“licensed by Board- Transfers must not exceed 5% of total Rxs / yr”
Adulterated
“Fails to conform to compendial standards for purity, quality, strength- Failed to store under USP standards”
REMS Elements
“Assessments at 18 mo, 3y, and 7y post marketing - Plan can limit to providers w/ certain training, dispensing in certain settings, limit distribution pending lab tests, enroll pts in registry, monitor each pt use
OTC Label
7-point: Product name, name of manfac/packager/distrib, net contents, active ingredients, name of any habit forming drug, cautions and warnings, adequate directions
Medication guides
Developed by FDA for certain drugs (ex:NSAIDs), replaces PIL, pharmacist can not withhold from pt if requests
CRCs
“All Rx drugs, many OTCs (ASA, NSAIDs, Fe, Benedryl) - Exceptions; Nitroglycerin, cholestyramine, oral steroids <105, K supplements <50 mEQ, aerosols for inhalation, OCs) - In WA –> CRC exemption must be written (federal law = written or oral)”
Label requirements
Provider, serial number, date of Rx filling, name of dispenser, name of patient, drug and strength, directions for use, expiration, quantity, RPh initials, Rx transfer warning, “side effect statement” - can be on label, on cap, on PIL, ets
Practitioners with Rx authority
MD, DO, Podiatrist (PodD, DPM), Dentist (DDS, DMD), Vet (DVM), ARNP, PAs, Naturopath, ODs, pharmacist, midwife
Out of state prescribers NOT valid
“Naturopath, optometrist, pharmacist, midwife - From BC - Same list, but no CS”
CDTA Reqs
ID of prescriber and pharmacists covered, renewed q2y, statement of procedures, activities required of pharmacist, filed with the board (commission does NOT approve protocol)
Rx on tamper-resistant pad
ALL written Rxs handed to pts on state-approved tamper-resistant pad — does NOT apply if Faxed, oral, e-Rx
Fax requirements
Date, time, phone #, location of FAX – considered an image of a written NOT an electronic form
eRX requirements
system must be approved by board - must allow for DAW code -
Generic sub
60% of savings must go to customer
Refills laws
PRN=1y
Administration of drugs
Certification for pharmacist NOT required
Sale of syringes
Not required to sell, but lawful
Compounding regs
Can distribute out of state if less than 5% of total Rxs
USP 795
“Applies to non-sterile prep, exiration dates range from - non-aqueous liquids - NTE 6 mo, or 25% of mfr label if made from mfr product - aqueous - 14d, stored in fridge - all others - 30D “
USP 797
Applies to sterile products, standards for low-m-hi risk compounding
Requirements for compounded products
name of preparation, internal ID number, BUD, initials of compounder, storage requirements, then lable requirements
Compounding Accreditation
PCAB - voluntary, but might be required by insurance
Prescribers limited in CS Rx
“ARNP and PA - all schedules per MD and specialty - Optometrist - No CII - no more than 7DS of C3-5 , single benzo for pre-procedure - Naturopath - CIII and IV testosterone and codeine”
DEA number format
2 letters (1st A/B/F, M for MLP, 2nd letter is last name initial, 6 digit number)
DEA Forms
“222 - order form - 106 - reports of loss or theft - loss includes dispensing error - 41 - inventory of drugs to DEA for disposal - Must maintain for 2 years”
CS Rx Reqs
“Name, address, date written, drug/quant/directions, physician address, physician DEA, physician name - RPH in WA can add missing info after consultation with prescriber”
What can PharmD change on CIII-V
“Anything BESIDES pt, drug name - CAN change pt address, dosage form, strength, quantity, directions for use, issue date”
C2 Exp
Under federal law none, but 6 mo in WA
CS written on same day
OK, no more than 90 DS authorized, each Rx includes earliest fill date
Filing of CS
“C2 must be separate from all others - CAN file C3-5 with Legend”
Indications for non-narc C2s
Narcolepsy, hyperkinesis, epilepsy, depression refractory to tx, MS
Rules for OTC C-V
“Opium antidiarrheals - 240 mL - No more than 1 sale per 96h, or 2 sales in 60d”
Meth precursors
“ephedrine, phenylpropanolamine, pseudophed - maintain log x 2y (electronic logbook OK) - only Age>18”
EPP limits
“daily 3.6 - monthly 9g”
Office based narcotic maint programs
DATA waiver - DEA starts with X - can fill buprenorphine (Suboxone) -
