NC Update (STOP), OBRA, Compounding, Techs, Pharmacy Practice Act Definitions Flashcards
(40 cards)
STOP Act
RPh must report required all CS info to CSRS (CS reporting system) by the close of business the next business day after delivery; RPhs must attest that they are personally registered for the CSRS or exempt (do not dispense CS) in order to renew annual license or for retirees to continue active license
STOP with TCS (Targeted CS)
acute pain limited to 5 day supply, post-sx procedure acute pain relief limited to 7 day supply, does not apply to chronic pain. can get another rx (1 at a time), but each rx limited in this way (clinical judgment). by 1/1/2020 TCS required e-rxs, PAs and NPs required to consult with supervising MD to prescribe TCS if for pain mgmt facility or if for TCS use >30 d, RPh not required to determine if this has occurred.
TCS includes
all opioids in C2 and C3 (apap/codeine, paregoric, buprenorphine, etc)
Dispenser Immunity
a dispenser shall be immune from any civil or criminal liability or disciplinary action from the BOP for dispensing a rx written by a prescriber in violation of this section. corresponding responsibility still apply.
USP 800
delayed until 12/01/2019, hazardous drugs, counting/pouring med will not need powder containment hood
opioid contained cough meds for children
not indicated for children under 18. can be prescribed off-label, can still fill liquid hydrocodone rx for 14 yo. MDs not limited by FDA
TCS in hospice/LTC
disposal of TCS must be addressed by oral and written info to the patient and fam whenever TCS might be prescribed. LTC facility may assist in destruction
Red Flags
a) dispenser believes drug seeking behavior other than tx of chronic med cond. b) prescriber or user is located outside of usual geo area. c) pays with cash when insurance info on file. d) user shows signs of potential misuse of CS. requires dispenser to review CSRS for preceding 12 months and document review if have red flags.
Signs of Potential Misuse of CS
a) over utilization of CS. b) requests early refills. c) utilizes multiple prescribers for CS. d) appears overly sedated or intoxicated when presenting rx (pin point pupils). e) request by first time patient for opioid drug by specific name, color, ID markings or street name.
Medicaid Variation of early fill
may not refill until 85% of previous rx is completed (25.5 days of a 30 day supply), prior approval required if exceeding 120 mg morphing equivalents/d and for LA TCS >7 d (to match STOP act). pain 2ndary to cancer excluded from prior auth.
Medicaid: PA vs emergency
may dispense 72 h supply until the PA arrives for Medicaid benificiaries
Holy Trinity
drug seeker with rxs for opioid, benzo, and carisoprodol (Soma). getting all 3 is red flag. use a different muscle relaxant instead of Soma. benzo and opioid without Soma is fine. Addition of alcohol is worse. other red flags: high dose opioid or high dose benzo.
Obra 90
guidelines to follow to be reimbursed by fed for medicaid services, requires RPh to make offer to counsel, NC requires offer to counsel on ALL (not just medicaid) new and transferred rxs and refills at the RPh pro judgment. omnibus reconciliation act of 1990. can be in person or by phone. written info allowed instead of verbal only if foreign language. pt may refuse. RPh documents refusals only. Offer must be made in pos manner to encourage acceptance.
Required counseling
name + description + purpose of rx, route + dosage + admin + continuity of therapy, special directions of use, common and serious ADR info, self-monitoring info, storage, refill, missed dose. must be done by RPh, offer can be made by anyone. in hospital, counseling can be made by authorized non-RPhs (RNs), required upon discharge, if inmate then not required to be face-to-face
DUR (Drug utilization review)
prospective - before dispensing, reasonable effort to review and update pt profile. RPh should review rx and pt records for over/under utilization, correct dosing, tx dupe, drug disease contraindications, DDIs, incorrect duration of tx, drug allergy interactions, and clinical abuse/misuse. RPh documentation of this. if third party performs DUR, RPh doesn’t have to
Patient Profile
make reasonable effort to collect: name + add + DOB/age + gender of pt, hx if significant including disease states + allergies + ADRs, comprehensive list of rx and OTC drugs and devices
USP-NF
US Pharmacopoeia and National Formulary is official compendia, specifies what must be done to satisfy the standards for strength, quality, purity, packaging, and labeling. monographs on each chemical. pt use monographs also included.
USP 795
non sterile compounding, OTC compounding not allowed witthout rx (otherwise unapproved new drug). BUD (beyond use dating) for topicals and PO suspensions. record keeping (formulation + compounding record including calc) allows for refills, check current BOP inspection forms. compounding for office use for humans not allowed per Drug Quality and Security Act (Track and Trace Law) - allowed for animals. all compounding requires rx. compounding copy of manu drug illegal (must be altered). powder containment hoods will eventually be necessary to required. batches must be examined/tested to assure consistency, appearnace, taste, smell
USP 797
sterile compounding, pursuant to individual pt rx only, no office use compounding (pt CAN have rx compounded and take to MD office), only outsourcing facility may compound for office use (register with FDA, follow cGMP), pharamcy may compound for vet offic use.
Label on Compound Rx
include all active ingredients OR commonly used name, (ex. magic mouthwash).
BUD of swishing meds
BUD of swish and swallow is 14 days under refrigeration. BUD of swish and spit would be 30 days under room temp per USP 795.
Pharmacy Technician Training
Trained with RPh within 180 days employment in pharm terms, pharm calc, dispensing systems and labeling requirements, pharmacy law and reg, record keeping and documentation, proper handling and storage of meds
Technician: Pharmacist Ratio
2 techs: 1 RPh unless rquest approval from BOP AND all additional technicians be CPhTs. Does not apply to pharmacy interns.
Tech Check Tech Rule
validates techs to do final check in acute care hospitals in specific situations, must be CPhT (but not all CPhT will be validating techs - is specific designation by hospital), must hold AA in pharm technology from NC community college system or institution accredited by accrediting agency recognized by US Dept of Ed or program accredited by ASHP.
