Maryland Pharmacy Laws and Regulations: A Comprehensive Guide, Exams of Advanced Education

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MARYLAND MPJE EXAM 2024 WITH 100% CORRECT ANSWERS Pure Food and Drug Act of 1906 (Wiley Act) - correct answer✔✔ Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 - correct answer✔✔ Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 - correct answer✔✔ Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 - correct answer✔✔ Manufacturer's must prove that a drug is both safe and effective Poison Prevention and Packaging Act of 1970 - correct answer✔✔ Required child-resistant (C-R) packaging for drugs and dangerous household substances Exempt for C-R packaging: SL nitroglycerin Must record request for non C-R packaging on prescription or patient's profile Prescription Drug Marketing Act of 1987 - correct answer✔✔ Laws prohibiting reimportation of drugs Patients can not buy drugs in other countries and bring to US unless: 1. It is for a 90 day supply or less and for that specific patient (not resold) 2. Effective treatment not available in the US, the condition is serious, and drug has no unreasonable risk Omnibus Budget Reconciliation Act of 1990 - correct answer✔✔ Required counseling and patient profiles for all Medicaid patients Dietary Supplement Health And Education Act of 1994 - correct answer✔✔ Defined dietary supplements as food products MD Board of Pharmacy Members - correct answer✔✔ Total of 12 members: 10 pharmacists (must have 5 years of practice) representing: Chain Independent Acute care At large Long term care Home infusion 2 consumers, appointed by the governor MD Board of Pharmacy Term Length and Removal - correct answer✔✔ 4 years, may serve 2 consecutive terms Member may be removed if they miss 2 consecutive meetings without being excused (and for incompetence, misconduct) MD Pharmacist Licensure Requirements - correct answer✔✔ 1. Good moral character 2. At least 18 y/o 3. Graduate of ACPE pharmacy school 4. Completed professional 5. Accept or transcribe new prescriptions 6. Accept transferred prescriptions 7. Give or accept transferred rx for a CDS (which means they can give a transfer for a non-CDS) 8. Independently compound (but they can compound under direct supervision) 9. Administer medications 10. Accept the return of prescription drugs/devices from a patient Pharmacy Intern Registration Requirements - correct answer✔✔ Currently enrolled in and completed 1 year of pharmacy education or graduated from a pharmacy program Pharmacy Intern Registration Renewal - correct answer✔✔ Intern registration is good for 2 years May be renewed one time only Tasks that a pharmacy intern is NOT allowed to perform - correct answer✔✔ 1. Final verification 2. Delegating pharmacy acts 3. Any act not authorized by supervising pharmacist 4. Represent as a pharmacist 5. Dispense medications when Rph not in pharmacy 6. Be present in pharmacy when Rph is not on-site 7. Independently compound 8. Accept return of prescription drugs/devices from a patient 9. Act within the parameters of a therapy management contract Pharmacy Permit Expiration Dates - correct answer✔✔ Renewed every 2 years Expires May 31st on even years Facilities that Require Pharmacy Permit - correct answer✔✔ 1. Pharmacies 2. In-state distributors 3. Out-of-state distributors that distribute into MD 4. Non-resident (out of state) pharmacies that provide pharmaceutical care to MD patients 5. Sterile compounders 6. Manufacturers distributing drugs and devices in MD Opening Requirements for a MD Pharmacy - correct answer✔✔ 1. Class A prescription balance or equivalent 2. Refrigerator with thermometer 3. Equipment sufficient for scope of practice 4. Hot and cold water 5. Reference material sufficient for scope of practice 6. Current MD Law book 7. Security system and means of securing pharmacy if hours differ from front store 8. Name of main pharmacist 9. Pharmacy must be operational within 60 days of permit (or permit will be rescinded) Permit Holder Requirements for Permanent Pharmacy Closure - correct answer✔✔ 1. Must notify the board at least 14 days prior in writing 2. Board will inspect within 72 hours of closure 3. Any indication that the store was once a pharmacy but be covered/removed within 30 days of closure 4. Notify drug suppliers prior to closure 5. Notify public of closure date, where records will be transferred, how old records will be maintained and how they may access their records 5. On the day of closure, must have/surrender: copy of CDS inventory, unused/voided DEA Form 222s, MD permit, MD CDS registration, name/address/phone/DEA registration where drugs or records were transferred Establishments that may be Granted a Pharmacy Waiver Permit - correct answer✔✔ Specialized services, ie: Home infusion Inpatient hospital Non-sterile compounding Sterile compounding Nuclear pharmacy Veterinary care Prescription Expiration Dates - correct answer✔✔ Rx must be dated to be valid Rx must be filled within 120 days from written date MD Medicaid requires rx to be filled within 30 days from written date Prescription Refills - correct answer✔✔ Non-control: PRN refills up to 1 year from written date (not an actual law, but good practice) C3-C5: 5 refills within 6 months C2: no refills Drug Expiration Date on Prescription Label - correct answer✔✔ 1 year from the date filled or the drugs actual expiry date, whichever is sooner May be shorter than 1 year based on Rph experience/reference Generic Substitution - correct answer✔✔ Rph may sub. a generic unless the MD writes "brand medically necessary (BMN), dispense as written (DAW), do not substitute (DNS)" or patients requests brand If subbing a generic, Rph must: 1. notify patient in writing 2. charge cheaper price 6. Drug name (both brand and generic) and strength 7. Drug manufacturer (for generic only) 8. Patient name 9. Directions 10. Expiration date Refusing to Fill - correct answer✔✔ A pharmacist may refuse to fill an rx based on professional judgement Must notify prescriber within 72 hours May refuse to fill for moral reasons, but Rph must find another Rph to fill at same location or another location convenient to the patient Pharmacy Quality Assurance Program Requirements - correct answer✔✔ 1. Document periodic review (every 6 months) 2. Include analysis of delivery system 3. Identify high-alert meds 4. Maintain records for 2 years Disposal of Expired Drugs - correct answer✔✔ May be returned to manufacturer, distributor/wholesaler, reverse distributor CDS returns through a reverse distributor or request DEA to allow on site destruction. Hospitals can dispose with a witness, comprehensive care can dispose with a witness or pharmacy maintained receptacle CDS returns must have records maintained for 3 years Reporting Lost/Stolen CDS - correct answer✔✔ Must reports to local police, MD BOP, DEA (via form 106), and MD DDC Reporting Lost/Stolen DEA Form 222 - correct answer✔✔ Report to local DEA office Requirements for Drug Delivery - correct answer✔✔ 1. Must document authorization to deliver 2. Must have Rph readily available for consult 3. Must be delivered to the patient or their agent (no depots) 4. Must be labeled as to not indicate drugs are inside 5. Must be packaged to show evidence of tampering Rx Transfer Requirements - correct answer✔✔ Record of transfer and all rx info Original date,date of first fill, last refill date, (and other refill dates?) Refills remaining Original Rx number Name of both pharmacies and pharmacists Transfer date Prescriber info Prescription Record Requirements - correct answer✔✔ Most must be maintained 5 years Medicaid patients: 6 years Medicare patients: 10 years Agencies that Conduct Inspections of Pharmacies - correct answer✔✔ MD BOP (opening and annual inspection [unannounced]) DDC CDS inspections (closing inspection as board's agent) DEA FDA Agencies that can Impound Drugs from a MD Pharmacy - correct answer✔✔ FDA DEA DDC Repackaging Bulk Containers to Unit Dose in the In Patient Setting: Requirements for Records - correct answer✔✔ Log should contain: 1. Drug name, strength, quantity 2. Manufacturer, lot number, expiry date 3. Hospital assigned lot number Pharmacist Consultation in Assisted Living Facility and Comprehensive Care Facility Requirements - correct answer✔✔ Assisted Living: Rph must conduct on-site review of patient meds every 6 months for any resident with 9 or more drugs (including OTC and PRN) Comprehensive Care: must review every 3 months PDMP Requirements - correct answer✔✔ All C2-C5 drugs dispensed must be reported within 3 business days of dispensing Pharmacies, non-resident pharmacies, and physicians that dispense must report Vets, hospital pharmacies (direct administration of drugs), opioid maintenance programs, waiver pharmacies are typically not required Must notify patients of reporting/using PDMP via a sign posted in waiting area or written material given to patient Non-Pharmacist Dispensers Licensure - correct answer✔✔ Usually licensed by their respective board