Pharmacy Licensing, NCBOP + Basic Rules

Question 1

Requirements of Licensing of RPh

Answer 1

submit app, graduate from accredited SOP or COP, receive PharmD (entry level pro degree), acquire required intern experience (1500, allowed by school in NC), minimum age 18, pay exam fee, license expires 12/31 annually

Question 2

New RPh License

Answer 2

must take/pass MPJE and NAPLEX of >75 score each, must take and pass both tests within 2 years, max 5x taking each exam. if not passed <5x then ineligible for licensure.

Question 3

Reciprocity

Answer 3

originally licensed as RPh by exam equivalent to NC exam, achieved score 75, licensed by state that deems NC license equiv to their exam, take and pass MPJE (75+ but may retake after 30 days), allowed by all states now

Question 4

Requirements for Licensure of Foreign Graduates

Answer 4

pass test of english as foreign language (TOEFL) with min score of 55 in each section and total of 550+. must also pass test of spoken english (TSE) with at least a 55. must pass foreign pharmacy graduate equivalency exam (FPGEE) and receive certificate. must provide documentation of DOB and place of birth. must do 1500 hours of practical experience. must pass NAPLEX and other required exams for licensure.

Question 5

Info to be reported by RPhs to BOP

Answer 5

notify within 30 days if beginning or changing employment (dates, name of employer, address of practice location, type of practice), change of name or home address. may do this online.

Question 6

Continuing Education

Answer 6

15 hours of CE in previous calendar year immediatley preceding exp of license (12/31), at least 5 hours must be live (contact hours - some online courses apply). CEs must be ACPE approved, NCAP CE courses OR precepting pharmacy students

Question 7

Pharmacists Exempt from CE

Answer 7

first time renewal RPhs (except reciprocity), waiver or extension for reasons such as military service (VA follows fed law only), retired RPh holding paid “inactive” license must pay renewal fee but if wanting to enter active practice then must complete missing CE (15/each yr out of practice)

Question 8

Reinstatement of license policy

Answer 8

out of practice (OOP) <2 yrs - obtain 10 h of CE for each yr OOP, half must be contact, and take MPJE. OOP <5 yrs - obtain 500 h of internship, 10 h of CE for each yr OOP (half being contact), pass MPJE. OOP >5 yrs - obtain 1500 h of internship, pass NAPLEX and MPJE.

Question 9

BOP

Answer 9

BOP created by NC general assembly to ensure min stds of competency (licensure), to protect public from those who might present danger to public health safety and welfare, meet monthly over skype.

Question 10

BOP Elections

Answer 10

voted on by entire state with paid license (active and inactive) and state residency for 5 rphs. 6th public member is appointed by governor. term limit is 2 consecutive 5 year terms.

Question 11

executive director to BOP

Answer 11

serves as secretory to bop, must be rph, may or may not be bop member. acts as prosecuting attorney to investigate violations and may file complaint and prosecute offender at bop hearing.

Question 12

bop registration

Answer 12

registers out of state pharmacies (mail order and internet) + instate pharmacies (health dept, home infusion, hospital/LTC/nursing home, retail, nuclear), same rules as instate pharmacies, if differ in state laws to have discrepency - state of residence rules preside. registers device and medical equip providers. pharmacies may sell DME wthout separate registration as DME provider. registers rphs and licenses, CPhTs too.

Question 13

DME requiring Rx

Answer 13

medicinial o2 must have l/min. devices requiing rxs are those which could be misused or cause harm (nebulizers, suction pumps, o2 equip, feeding pumps, cpap/bipap machines

Question 14

Disciplinary Authority

Answer 14

letters of warning, caution, or reprimand. suspsends, restricts, revokes, or refuses to grant or renwe license. may require remedial edu (MPJE)

Question 15

Violations

Answer 15

false presentations or withheld info in connection with securing license, permit or renewal - DWI record, drug convictions, any felony or misdemeanor. after securing license, permit, or renewal - felonies specifically in connection with the practice of pharmacy or dist of drugs. indulge in use of drugs that render unfit to practice pharmacy (etoh, recreational drugs), make false statements in connection with practice of pharmacy that could endanger the public or defraud any person, physical or mental disability that render unfit to practice (blindness, IVC), fail to obey laws and reg of pharmacy. negligence.

Question 16

Hearings

Answer 16

informal (can have attorney): 1 bop member hears case as mediator, submit case to bop with rec to dismiss with no action, rec to resolve by consent (to punishment), or schedule contested hearing. if hearing goes to bop as contested, hearing mediator member is dq from voting. formal hearing: may have attorney, may call witnesses, may petition for dq of any bop member who may be biased. decisions can be appealed for judicial review <90 days.

Question 17

Pharmacy Recovery Network

Answer 17

NCBOP relationship dissolved fall 2015. new agreement with NC physicians health program to evaluate and monitor rphs and personnel (current clients of NCPRN will be transitioned to this). can be self/employer/bop referred but if bop refers then bop knows all. otherwise only reported to bop if violation of program.

Question 18

Inspectors

Answer 18

hired by bop to investigate complainets. aid in emergencies. perform routine inspections. pharmacies are inspected based on type of compounding they do at 1, 2, or 4 year intervals

Question 19

Confidentiality and availability of pharmacy records

Answer 19

written rx orders are not public, only released to: adult pt for who the rx was written for or a legally appointed guardian, or an emancipated minor or their legally appointed guardian. spouse only if deceased. otherwise only in emergency.

Question 20

Confidentiality and availability of pharmacy records for unemancipated minors

Answer 20

minor’s consent is sufficient to authorize tx of the condition the rx is for (dx, ppx, or tx): preg, std, drug/etoh abuse, emotional disturbance. condition specific, not drug specific. otherwise, parent authorized to pharmacy records (ex. strep throat). tricky with spending reports.

Question 21

Requirements of Rx order

Answer 21

date, pt name + add, MD name + add + phone#, DEA# if CS. *may be in central data storage if not on Rx. drug name, strength, qty drug, refills or stop date, route (can be assumed in retail), directions (not use as directed unless pt understands), rx#

Question 22

PRN refills

Answer 22

limited to 1 yr from date written unless otherwise indicated. unless CS, no time limit for filling. insurance limits to 1 yr. if paying cash, use pro judgment.

Question 23

Placebos

Answer 23

labeled and counseled as real drug. charge as real drug to pt, do not charge to insurance. not considered misbranding. needs call in for confidentiality, but only to you/your pharmacy.

Question 24

Additional CS requirements of Rx order

Answer 24

dated, signed on date when issues, written in ink. manually signed unless oral, street add of pt (no PO). Red C stamp required when not computerized and if org sys requires it.

Question 25

Requirements of Rx Label

Answer 25

pt name, pharmacy name + add, “filled by…” or “dispensed by…” rph name not initials, rx#, date of rx, MD name, directions, brand + generic name, discard date (1 yr or manu exp date whichever shorter). refills not needed. toll free# for ADRs with FDA required on label or pt documents provided. caution statement required for CS.

Question 26

Transfer of Rx Info

Answer 26

“transfer”, original date written, original refills, date + time of transfer, refills remaining, last refill date, pharmacy name + add + original rx#, transferring RPh or CPhT, manu or brand dispensed. phone# not required but helpful. DEA# if CS between 2 RPh only.

Question 27

Fax Requirements of Rx

Answer 27

date + time, phone # + location of fax machine, name of operator of fax machine, sig of MD. refill orders do not need MD sig. faxed rx needs other requirements of traditional rxs.

Question 28

extra rxs during emergency

Answer 28

overrides refill too soon rejection, only for 1 replacement. conditions: commissioner issues bulletin for all insurance carriers, person resides in county declared to be a disaster area by president/governor, refill requests <29 days of disaster, qty limits recog proportionate dosage use prior to disaster (addict doesn’t evacuate without pills)

Question 29

Dispensing Errors

Answer 29

will be documented, reported to rph manager, include all chrono info including name of person responsible, open to bop, include action taken as part of quality assurance plan, will not be released except as required by law (confidential)

Question 30

quality assurance legislation

Answer 30

evaluates the quality of pharmacy, cause of med errors, care outcomes, possible improvements for pharmacy, methods to reduce med errors. may designate agent in addition to rph manager to whom notice of investigation may be given. proceedings of qa program confidential, cannot be required to testify. if bop inquires, rph manager or agent must provide documentation of error if it resulted in MD/ED visit, hospitalized >24 h, or death. AND if disciplinary proceeding has occurred, then other erros unrelated to event must be provided to help determine remedial action

Question 31

Robotics

Answer 31

barcoding required when stocking by tech or RN, daily audits, policies and procedures for all settings.

Question 32

Notifying BOP

Answer 32

disaster/emergency: notify board <10 days if drug strength, labeling or purity is affected. robbery: DEA and local police, BOP too (required in hospitals)

Question 33

Identification

Answer 33

ID badges with name and specialty necessary in institutions. not required if degree can be determined by posting the degree on the wall where readily visible. not required if it compromizes sterile dress. not required when dealing with inmates.

Question 34

Naloxone

Answer 34

RPh can dispense naloxone IM or IN under standing order from local MD, health/med director of local health dept OR med director of NC harm reduction coalition, RPh immune from liability if dispensed this way under good samaritan law., can bill to insurance, part D, medicaid. free from NC HRC.

Question 35

Dispensing more than face amount

Answer 35

legal if not medicaid or insurance rxs - unless document MD call on hardcopy, pro judgment, non-CS, non-psych drug. otherwise cannot.

Question 36

150 rx/day

Answer 36

only enforced IF mistake occurs, and IF BOP hearing results and IF the pharmacy filled more than 150 Rxs/RPh/day then pharmacy will suffer the same penalty as given to the RPh.

Question 37

Inoculations

Answer 37

RPh completes approved course (CDC, ACPE, BOP approved), current in CPR certification or disabled RPh working with CPR certified person. Flu vax >14 yo, other vax >18 yo. Complete training on NC Immunization Registry before admin via protocols, must notify BOP of immunizing status. must acces registry prior to any vax except flu.

Question 38

inoculations allowed to admin

Answer 38

pneumococcal, zoster, hep b, meningococcal, tdap (not tetanus alone). all other CDC rec vax are by rx only and not by protocols.

Question 39

vaccination documentation requirements

Answer 39

pt name + add + DOB, date of admin, site of admin, route, name + manu + lot# + exp of vax, dose, PCP name (ED or health dept), admin RPh initials/name, anything else required by registry

Question 40

investigators of other boards

Answer 40

med board, nurse board, etc may examine pharmacy records during the course of investigation of licensee

Question 41

nuclear pharmacies

Answer 41

MD must be authorized to possess, use and admin radio-rxs before qualified radio RPh can dispense.

Question 42

CPP

Answer 42

clinical pharmacist practitioner, must be spelled out on nametag, required 35 h CE/yr, may prescribe CS (DEA will assign # starting with M)

Question 43

Work related

Answer 43

RPh not required to work >12 h straight in day. if working 6+ h then 30 min meal break and 15 min other break are required.

Question 44

prescription authority

Answer 44

PAs, NPs, CPPs authorized to prescribe ,order, admin drugs and devices, assigned a license number by medical board must be on rx, written instructions for prescribing and written policy for periodic review. in order to compound (other than CPP), need approval from BOP

Question 45

CSRS

Answer 45

needs payment info in addition to normal info, confidential law enforcement + RPh + MD have access.

Question 46

return

Answer 46

no CS, no biologics or refrigerated drugs, no compounds or IV mixes. any pharmacy may accept and redispense but must notify NCBOP in writing and annually. must be original, unopened, sealed and tamper-evident packaging or unopened single-unit unit-dose. must be physically separate from other inventory (exp > 6 mo).

Question 47

Return requirements

Answer 47

name, strength, dosage form, number of units, lot number, exp date, and name + add + phone of donor. hard copy rx must say donated drug was dispensed, written policy for pt eligibility (you decide), may not charge for drug but may charge dispensing fee (not to exceed medicaid copay of $3). all identifying labels indicating the donor must be removed.

Question 48

ID

Answer 48

for all C2 need 18+. For C3-5, need ID not 18+. keep ID infor for 3 yrs. only accept NC DMV ID, DL from anywhere, military ID from anywhere, passport from anywhere. caregiver can pick up with their ID. not for inpatients. hospital ID not sufficient.

Question 49

Pharmacy Insurance Audit Rights Law

Answer 49

14 day adv notice, rph makes clinical judgment - not insurance. clerical or recordkeeping errors will not be considered fraudulent unless other evidence. limited to 100 selected rx if for identified problem (otherwise limited to claims of rx#), if additional needed then on site only. limited to 1 yr per PBM unless problem suspected. allowed 30 days to address discrepancy, limited to 24 mo from date claim was submitted unless longer period permitted by plan (medicare part d 10 yrs)

Question 50

needles and syringes

Answer 50

NC allows sale at discretion of pharmacist

Question 51

no audits when

Answer 51

first 5 days of any calendar month without express consent of pharmacy. pharmacy will cooperate to establish alternative date. prelim audit reopt must be delivered within 120 days of conclusion. final report required 90 days after end of appeals period.

Question 52

recoupment

Answer 52

refunded to responsible party, occur only after final disposition unless fraud suspected. recoupment is dispensing fee only (cost of drug excluded) unless fraud, dispensing in excess of benefit amt, rx not filled according to MD’s order, actual overpayment to pharmacy. fee not included if rx not dispensed, approved by MD, med error, extra dispensing fee error, insufficient documentation, fraud