NC Update (STOP), OBRA, Compounding, Techs, Pharmacy Practice Act Definitions

Question 1

STOP Act

Answer 1

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

Question 2

STOP with TCS (Targeted CS)

Answer 2

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.

Question 3

TCS includes

Answer 3

all opioids in C2 and C3 (apap/codeine, paregoric, buprenorphine, etc)

Question 4

Dispenser Immunity

Answer 4

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.

Question 5

USP 800

Answer 5

delayed until 12/01/2019, hazardous drugs, counting/pouring med will not need powder containment hood

Question 6

opioid contained cough meds for children

Answer 6

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

Question 7

TCS in hospice/LTC

Answer 7

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

Question 8

Red Flags

Answer 8

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.

Question 9

Signs of Potential Misuse of CS

Answer 9

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.

Question 10

Medicaid Variation of early fill

Answer 10

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.

Question 11

Medicaid: PA vs emergency

Answer 11

may dispense 72 h supply until the PA arrives for Medicaid benificiaries

Question 12

Holy Trinity

Answer 12

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.

Question 13

Obra 90

Answer 13

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.

Question 14

Required counseling

Answer 14

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

Question 15

DUR (Drug utilization review)

Answer 15

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

Question 16

Patient Profile

Answer 16

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

Question 17

USP-NF

Answer 17

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.

Question 18

USP 795

Answer 18

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

Question 19

USP 797

Answer 19

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.

Question 20

Label on Compound Rx

Answer 20

include all active ingredients OR commonly used name, (ex. magic mouthwash).

Question 21

BUD of swishing meds

Answer 21

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.

Question 22

Pharmacy Technician Training

Answer 22

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

Question 23

Technician: Pharmacist Ratio

Answer 23

2 techs: 1 RPh unless rquest approval from BOP AND all additional technicians be CPhTs. Does not apply to pharmacy interns.

Question 24

Tech Check Tech Rule

Answer 24

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.

Question 25

Situations for Validating Technicians

Answer 25

a) stocking of patient care unit meds. b) stocking of ancillary drug cabinet inventories. c) stocking of automated dispensing or drug supply devises. d) stocking of emergency kits. e) prepackaging of rx drugs. rph manager responsible for parameters of rph supervision in these functions, also for record keeping function to ID the validating technician. compounds and admixed rx drugs MUST BE CHECKED BY RPH.

Question 26

Legend Drug

Answer 26

Rx drug which requires either RX ONLY or CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION or be a vet labeled drug

Question 27

emancipated minor

Answer 27

under 18 AND: a) is/has been married, b) is/has been a parent, c) parent surrendered rights to minor’s services and earnings, d) emancipated by court orders

Question 28

dispense

Answer 28

pertains to processing a drug or device for delivery or for administration. does not include delivering a drug or device to patient or administering drug or device to patient (ex. inoculation law required for immunizations)

Question 29

the practice of pharmacy means

Answer 29

interpreting and evaluating drug orders, compounding, dispensing and labeling rx drugs, storing drugs properly and safely, maintaining records, controlling pharmacy goods and services

Question 30

pharmacy intern

Answer 30

registered under BOP program or part of school’s academic program. may perform all acts constituting practice of pharmacy while under supervision of a rph.

Question 31

RPh Supervision

Answer 31

RPh must physically review rx orders and dispensed products before they are delivered to pt. (telemed may change this)

Question 32

cocaine

Answer 32

legally a narcotic

Question 33

Product substitution

Answer 33

generic sub allowed if same active ingredients, strength, qty, dosage form. not mandatory, rph choice.

Question 34

Narrow Therapeutic Index (NTI) drugs

Answer 34

must be filled with same manu as last dispensed unless: prescriber notified, prescriber gives documented consent, AND patient gives documented consent. also applies to new rx which continues a pt’s tx.

Question 35

NTI Drugs in NC

Answer 35

carbamazepine (tegretol), cyclosporine, digoxin (lanoxin), ethosuximide (zarontin), levothyroxine, lithium (eskalith, cibalith, etc), phenytoin (dilantin), procainamide, tacrolimus (prograf), theophylline (elixophyllin, slo-phyllin, theo-dur, uniphyl, theo-24, etc), warfarin

Question 36

AB rating and NTI drugs

Answer 36

rating of NTI drugs is what rph should use if switching brands is considered, documented consent is (still) required

Question 37

Purple Book

Answer 37

To be published for biologic products (biosimilars) that can be expected to produce the same results as the reference drug and swithcing back/forth between must be safe and effective. sub of biosimilars allowed in NC, requires RPh to communicate to prescriber the name of the product as well as the manu within a “reasonable” time. BOP must maintain link to current list of products that are interchangeable.

Question 38

Ways to Prevent Substitution

Answer 38

prescriber noting “dispense as written” for 1 sig blank or 2 sig blank that specifically says “product selection permitted” and “dispense as written” in that order. if phone rx: must specific if sub is not permitted, otherwise its allowed.

Question 39

Medicaid and Substitution

Answer 39

requires “Medically necessary” handwritten on rx or fax, will not accept other words or abbreviations. no phone calls. except: NTI, seizure, preferred brands when generic not preferred. (must go to documentforsafety.org and prescriber must fill out e-form before claim pays)

Question 40

Labeling of Generics

Answer 40

recommended if generic then label “furosemide used for Lasix” or “Furosemide generic for Lasix”. generic needs to be on rx label of all drugs. if brand used: “Lasix (furosemide)”