P716 Law Final Exam

How to determine if DEA # is legitimate?

(Add 1st, 3rd, 5th #) + (Add 2nd, 4th, 6th #, then multiply by 2) *single digit of answer should be same as last digit of DEA#

What are the CE requirements?

- 30hr in 2yr period - at least 10hr live - 1hr pain - 1hr ethics & jurisprudence - max 12hr CE/24hr period - 90d to file after program *Keep certificates 4yr

What requirements for dispensing C5 OTC medication?

- > 18 yo - Label w/ date sold, pharmacist name, name/address of practice - Must be assessed by pharmacist

Who can be a licensed pharmacist? What are the requirements to be a licensed pharmacist? What are requirements to renew pharmacist license?

- > 18yo - 1600 practice hours - ACPE accredited program - Criminal background check - NAPLEX (45d before next attempt, 3x max in 1yr) - MPJE (30d before next attempt) To renew: - Q2yr w/ 30hr CE - 1x human trafficking, opioid/CS, implicit bias

Vaccine law relevant to pharmacist

- Document AE to VAERS - Need training + letter of delegation from physician - Can share info w/ schools & daycare - Must give VIS - Record vaccine info in medical record (required for children < 20, best practice for adults)

What is corresponding responsibility of pharmacist? What is scope of practice?

- Ensure RX is legit and/or appropriate - Counseling pt - Interpreting RX orders - Compounding, packaging, labeling, dispensing - Drug regimen screening - No prescriptive authority, but can have collaborative practice agreement & be dependent prescribers

What are the requirements to open a pharmacy - space, equipment, references, computers

- Floor to ceiling partitions that can be locked - Cold/hot water, fridge, dedicated compounding area - > 150 sq ft including > 10 sq ft free space (+ 4ft/additional pharmacist working simultaneously) - 2+ resources (online OK)

What are requirements for selling pseudoephedrine and related products?

- Limit 3.6 g/person/day - Limit 9 g/person/30d - Limit 7.5 g/per/30d via mail order or mobile retailer - Person must not possess > 12g - Not reported to MAPS, report in NPLEx or logbook

How do you get to be a licensed pharmacy preceptor?

- Must be licensed pharmacist in MI for at least 1yr - Application to LARA - Only precept up to 2 students at a time - Must train in specific areas

Rules for oversight of a remote pharmacy

- No existing pharmacy within 10 mi - Avg 150 scripts/d - Parent & remote must both be located & licensed in MI - RPh can supervise remotely through REAL TIME audio + visual

What are the rules for automated dispensing devices?

- Pharmacy can NOT own, control, operate device in dispensing prescriber's office - Needs own DEA registration if off site - RPh audit q30d - Pharmacist must review order within 48hr if med taken for emergency - Retain records for 5r

Who and what is the pharmacist in charge? (PIC)

- Responsible for compliance - Cannot be a PIC for > 3 pharmacies (including remote) - Work an average of 8 hrs/week - Does not have to be manager/owner of the pharmacy

What requirements to license a pharmacy? Become an internet pharmacy?

- Same address, same license. Different address, different license - 6-8wk process - Valid 2yr (renew on 7/1) - DEA registration needed if handling CS (Form 224) Internet pharmacy: same thing but if various locations under same ownership at 1 street address w/ same central inventory, only 1 license needed. Must follow requirements of state where it's physically located

What does NDC # indicate?

- Strength - Dosage form & formulation - Package size & type

What are the responsibilities of the PIC? When to report change in PIC?

- Supervise practice - P&P - Security - All activities regarding pharmacy Report change in PIC within 30d

Kefauver-Harris Amendment of 1962

- Transferred jurisdiction of RX drugs from FTC --> FDA - Required drugs to be proved SAFE & EFFECTIVE - Required informed consent for research subjects

How do you close a pharmacy? Requirements?

- Turn in DEA registration, unused DEA forms - Provide name, address, DEA# at least 14d before closing date

What can a pharmacist be disciplined for? What is the process? What are the sanctions that can be taken against a pharmacist or technician license?

- Violation of general duty - Fraud & conviction - Incompetence, SUD - Misdemeanor conviction - Not reporting change of name, address within 30d - Not fulfilling 30hr Sanctions: - Licensure action by BOP - BOP Disciplinary subcommittee - Fine, probation, suspension, revoke license

What are the rules for: - Auto injectable epinephrine - Opioid antagonist - Expedited partner therapy

Epinephrine can be dispensed to authorized agency (school, business like summer camp) Naloxone can be issued & filled to person other than pt, and can be prescribed to authorized agency, but pharmacy needs to register w/ department & provide quarterly reports Expedited Partner Therapy allowed for any partner in previous 60d diagnosis, no requirement for 3rd party to pay

Methadone can be prescribed and dispensed for opioid treatment True False

False (can be dispensed for pain or MAT)

What is a central fill pharmacy? What are the rules for central fill?

Fill RX on behalf of retail pharmacies - Both must keep records - Both responsible - Central pharmacy must keep copy of RX/electronic record of all info transmitted by retail pharmacy - Reports to MAPS come from filling pharmacy - C3-5: indicate # fills already dispensed & # remaining

What is the health professional recovery program?

HPRP for impaired healthcare professional - If voluntary, records expunged after 5yr - Operated by private sector

Record keeping requirements for various documents discussed in class

Keep 5 years: - Original RX at retail pharmacy - Records in central fill pharmacy - Cancer repository program forms Keep 2 years: - CS invoices - CS inventory count - Records of paper & electronic RX - Pharmacist dispensing log Keep 90d: - Copy of pt's RX receipt

What is the quantity limit in terms of days supply for a CII drug for chronic use that a physician's assistant in Michigan may write for? Unlimited (theoretically) 7 days 30 days 10 days

Unlimited (theoretically)

What is Board of Pharmacy responsible for? Who makes up the board?

BOP = admin agency in LARA, grants licenses (pharmacy, pharmacist, intern, manufacturer, wholesaler) 11 members (6 pharmacists, 4 public members, 1 pharm tech) 4 year term

DEA registration is required when handling controlled substances for all of the following entities, EXCEPT: a) Pharmacy b) Manufacturer c) Distributor (wholesaler) d) Pharmacist

D

Which of the following statements is true regarding a pharmacy conducting a controlled substance inventory in the community pharmacy located in Michigan. a) Must conduct exact counts on all controlled substances in the pharmacy (C2 through C5) b) Must be conducted every 2 years c) May be conducted anytime between September 1st and October 31st. d) Must be kept on site (registered location)

D A not true (exact count needed for C2, only needed for C3-C5 if > 1000) B not true because should be conducted annually C not true because should be done around May

What is DAW? What must we do with a prescription when it has DAW on it?

Dispense as Written (not required component of TX) - Denotes when specific brand or generic med needs to be dispensed

Duration of an individual controlled substance registration (license) for a pharmacist in Michigan

2 years

Know the DEA forms 222 106 41 How long to keep forms?

222: Transferring C2 (ordering, reverse distributor, disposal/destruction on-site) 106: Theft, significant loss 41: Destruction (needs 2 witnesses) Keep forms for 2yr

How can a pharmacy act as a wholesaler?

5% Rule If quantity pharmacy makes for another entity > 5% of total # units made in 1 year

Section 503A vs 503B

503A: Describes conditions for compounded drug produce to be exempt from... - 501a2b good manufacturing practice - 502f1 labeling w/ adequate directions for use - 505 approval of drugs under NDA/ANDAs 503B: traditional vs outsourcing facilities, pharmacies can register w/ FDA

USP 795, 797, 800 - what are these, what do they cover?

795: Non-sterile Compounding 797: Sterile Compounding 800: Hazardous Drugs in healthcare settings

A pharmacist practicing in community pharmacy in Michigan can NOT fill a prescription written by OUT-OF-STATE prescribers in which of the following scenarios? a) Nurse practitioner writing for a controlled substance prescription b) Canadian physician writing for non controlled medications c) MD physician writing for a controlled substance medication d) Dentist writing for a controlled substance medication

A

Which of the following statements is true regarding dispersal of C2 controlled substances in the pharmacy? a) Can be dispensed throughout the stock of controlled medications b) Must be securely locked in a substantially constructed cabinet c) Must never kept in the pharmacy

A

Which of the following is true regarding the tasks delegated by the pharmacist? Select all the correct answers a) The delegated task must occur while under the personal charge of the pharmacist. b) Pharmacy interns may administer immunizations under personal charge of the pharmacist c) Written policies are procedures regarding delegated responsibilities must be kept in the pharmacy d) Pharmacy technicians may counsel patients on OTC medications

A, B, C (not D)

Adulterated vs Misbranded

Adulterated = altered Misbranded = pt not given what label says

What are the rules for partial filling a controlled substance?

Allowed for C3-5 without "eating up" refills For C2s: - Total quantity dispensed as partial can NOT exceed total prescribed - Remaining portion should be filled no later than 30d after when RX written - If out of stock, may dispense remainder within 72hr

Which of the following statements regarding disposal of controlled substances in the pharmacy are true? a) There must be 3 employees witnessing destruction of controlled substances b) If destructing on site, making the controlled substance non-retrievable, includes incineration or chemical digestion c) a DEA form 107 is used for all controlled substances C2 through C5 when sending them to a reverse distributor

B A not true because 2 employees needed C not true because it's DEA Form 222

The pharmacy had a break in and 10,000 tablets of generic hydrocodone with acetaminophen were stolen. Which of the following are true? Select all that are correct. a) This is not a significant loss, so not reporting to the DEA is required b) A DEA form 106, (or letter explaining accounted for) is filed with the DEA c) A DEA form 41, must be filed d) Upon discovery, notify the DEA in writing within one business day e) A DEA form 107, must be filed with the DEA

B & D DEA Form 41 is for destruction/disposal Pharmacy doesn't report loss because they didn't claim it yet

Which of the following is TRUE? a) If non-controlled RX has no indication regarding refills, it can be refilled 1 time b) Prescriber can use signature stamp to sign paper RX handed to pt c) Fax-to-fax transmission of non-controlled RX must have manual signature of prescriber d) RX for non-controlled substance valid for 1 year from date of first filling

C B not correct because "wet" signature needed D not correct because RX valid 12m from date WRITTEN, not filled

Question 8: Which of the following statements is false? a) Administrative agencies in the government implement and enforce laws b) The legislative branch of government enacts laws c) When a federal and state law conflict, the federal law always takes precedence (trumps the state law) d) An example of a Federal statute is the Controlled Substances Act

C (because more strict law triumphs)

Inventories: - When are they conducted - What is inventoried - Counting process (C2 vs C3-5) - Storage of documents

Conducted when first engaged in dispensing, when there's new PIC, and annually (around May) Includes: - Drug name - Finished form - # units in each container & # of containers Need exact counts for C2 (C3-5 only if > 1000) Keep records in physical form for 2yr

What are customized patient medication packages? What are the various rules on labeling and dispensing these products?

CPMP - Solid dosage forms without DDIs - Designed & labeled to indicate day & time each dose taken - Has serial # or unique identifier - Each container must be able to show evidence of having been opened - Expiration date = earliest manufacturer expiration date or 60d after dispensing - Record of each CPMP must be made & filed

What if CS are stolen or lost in the pharmacy? What is considered significant loss?

DEA Form 106 Significant loss factors: - Quantity lost in relation to type of business - Specific CS lost - Is loss associated w/ individuals or activities? - Pattern of loss - Is CS candidate for diversion? - Local trends NOT breakage, spillage, if accounted for

How do pharmacies dispose of controlled substances? What are the various procedures?

DEA Form 41 if disposing - Must be witnessed by 2 employees - Must be non-retrievable DEA Form 222 if sending to reverse distributor

What is beyond use date (BUD)? How is the BUD determined?

Determined by if aseptically processed, sterility tested, room temp vs fridge vs freezer Category 3 BUDs: Room temp 60d Fridge 90d Freezer 120d

What is REMS (Risk Evaluation and Mitigation Strategies?

Drug safety program FDA requires for certain meds w/ serious safety concerns to ensure benefits > risks Focuses on preventing, monitoring, managing specific serious risk by informing, educating, reinforcing actions

Federal acts and amendments to the Food Drug and Cosmetic Act - Durham-Hemphrey - Delaney - Kefauver-Harris - Fair Packaging & Laebling - Drug List Act - Hatch-Waxman - RX Drug Marketing Act - RX Drug User Fee Act - DSHEA

Durham-Hemphrey: RX vs OTC, oral/verbal RX, Caution label Delaney: bans cancerous additives Kefauver-Harris: safe AND effective Fair Packaging: label must state drug identity, name + place of manufacturer, quantity Hatch-Waxman: Streamlines generic approval, patent extension RX Drug Marketing: no reselling meds RX Drug User Fee: manufacturers have to pay fee when submitting NDA DSHEA: Dietary supplements like food, decreased standards

Hospice med boxes vs Emergency boxes

Hospice box: - must include doc/label inside box listing all meds - Inspected weekly - RX for all drugs given must accompany box when returned Emergency box: - Pharmacist must review within 48hr - Audit q30d

FDA Recall Classes (I-III)

I: serious consequences or death II: Temporary or reversible consequences III: Not likely to cause adverse consequences

When can a pharmacy take back medications?

If medication was dispensed in error

When are drugs newly added to controlled substance list inventoried?

Immediately (day of) when they become labeled as CS

What is a cancer drug repository program?

Individual > 18yo & manufacturer, wholesaler, pharmacy can donate non-CS cancer drug/supplies to be used by another MI resident w/ diagnosed cancer Must be accompanied by drug donor form

How are C3-5 ordered by the pharmacy?

Invoices that must be readily retrievable

What are the requirements for counseling?

MUST be done for all new RX, can offer for refills but not required - Reasonable to have RPh available by phone - Printed info satisfies requirement

What is the MPJE? What is passing score? How many questions? How long to wait until next attempt if failed? How many times can you take it if you don't pass, until you need to take another pharmacy law course?

Multistate exam assessing application of laws & regulations 120 questions Passing score = 75 Must wait at least 30d until next attempt if failed If failed 3x, must request pre-approval from board of exam prep course or instruction If failed 5x, must enroll & complete pharmacy law course before taking again

What is duty to report?

Must report self & others Exceptions: - Learn of violation while providing professional services - Learn of violation as part of ethics, peer review, professional review committee

When can a C2 prescription be faxed?

NEVER (ok for C3-5)

Difference between prescribing authorities of NP vs PA

NP: must indicate delegating physician's name on C2-5 RX, but not on non-controlled PA: does NOT have to indicate delegating physician's name on ANY RXs

Which of the following parts of a prescription for morphine sustained release tablet can be changed by a pharmacist (after contacting prescriber, receiving approval for changes)? Prescriber name Quantity prescribed Patient name Drug prescribed

Quantity prescribed

What must be on a prescription drug label? Drug receipt?

RX Drug Label: - Date - Pt name - Prescriber name & address - Drug name, strength, quantity, directions, # refills - Manual sig (if paper) If CS: - Prescriber's name, address, phone #, sig, DEA # - Pt's name, address - Drug quantity (writing + number) Drug Receipt: Must include Drug, RX & Pharmacy info on receipt (keep copy for 90d)

What is the ratio of pharmacists to technicians working one time? Interns?

Non for tech to pharmacist 2 interns to 1 pharmacist if preceptor

How long is a script valid for (Non-CS, C2-5) & refills allowed?

Non-CS & C5: Valid 12m, unlimited refills C3-4: Valid 6m, 5 refills C2: Valid 90d, no refills

Regarding out-of-state prescribers: which ones can we take prescriptions from in Michigan?

Non-CS from out of state always OK If from dependent prescriber, delegation must be allowed by both states Canadian CS not allowed (non-CS ok)

What are the rules for transferring a prescription?

Non-CS: Can be done between pharmacists, intern or tech CS: - C2 transfer not allowed - C3-5 can be transferred ONCE - Only pharmacist & intern allowed to transfer/receive

What are the requirements for an emergency prescription?

Only prescriber may phone in (no delegation) & only pharmacist can take order (no techs) Write "Authorization for Emergency Dispensing" + Date RX must be given in writing to pharmacist within 7d

Poison prevention packaging act - what medications are exempt?

Requires child-resistant packaging for most OTC, almost all RX drugs (so that 80% kids < 5yr can't open & 90% adults can) Exempt: - Sublingual nitroglycerin - Oral contraceptives - < 105mg prednisone

What are the requirements for a prescription? - Paper - Electronic - Fax

Paper: - Hard copy of original RX - Manual signature Electronic: - Electronic record of original RX - Electronic sig - No change in RX from time written to time received Fax: - Printed copy of original RX - Manual signature - Computer to fax not allowed for C2

Know the various types of prescribers. What limitations, if any, do prescribers have, especially in terms of CS?

Physicians, Podiatrists, Dentists, Optometrists can write any RX within scope of practice Vets can prescribe to animals only Chiropractors can't prescribe anything APRN can only prescribe non-CS PAs can prescribe all (w/ CS license) with independent authority NPs can prescribe non-CS independently, C2-C5 w/ physician delegation

The Prescription Drug Marketing Act...

Prohibits hospital pharmacies from reselling meds to other businesses

What is the Prescription drug repository program (unused drug)?

Statewide program overseen by LARA Non-CS drugs (unused, donated) --> Medicare, Medicaid-eligible, uninsured individual w/ RX *cannot be resold, CAN charge handling fee

A resident may utilize a hospital's institutional DEA number to prescribe controlled substances True False

True

Differences between Traditional vs Outsourcing facility

Traditional Facility: compounds on per-patient scale - Regulated by state board - Does NOT need to register w/ FDA Outsourcing Facility: compounding on larger scale - Section 503B - Regulated by both state & FDA - Must register w/ FDA - Secretary of HHS has delegated authority - Subject to AE reporting, risk-based inspections

What type of signatures are required for various types of prescriptions?

Written & Fax: Manual (wet) Verbal: not required Electronic: E-sig