Maryland MPJE 2024 Edition. Questions & Correct, Verified Answers. Graded A+, Exams of Pharmacy

Download Maryland MPJE 2024 Edition. Questions & Correct, Verified Answers. Graded A+ and more Exams Pharmacy in PDF only on Docsity! Maryland MPJE 2024 Edition. Questions & Correct, Verified Answers. Graded A+ Agencies that can Impound Drugs from a MD Pharmacy - ANSFDA DEA DDC Agencies that Conduct Inspections of Pharmacies - ANSMD BOP (opening and annual inspection [unannounced]) DDC CDS inspections (closing inspection as board's agent) DEA FDA Changes that must be Reported to the MD BOP - ANSPharmacist's name, mailing address, primary employment must be reported within 30 days of change Exception: when primary employment change is within the same chain (but to a different location) may report upon license renewal Compounding Requirements for Pharmacy - ANS1. Must be for individual patient 2. May not be a copy of an FDA approved drug 3. The product must be safe and effective (can't compound something that was removed from market for safety issues) 4. Product is not commercially available or patient requires a different strength/dosage form 5. Bulk drugs must comply with USP/NF and Rph must comply with USP 795/797 6. Can perform anticipatory compounding, but must not exceed 5% of annual rx volume Dietary Supplement Health And Education Act of 1994 - ANSDefined dietary supplements as food products Disposal of Expired Drugs - ANSMay 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 Drug Expiration Date on Prescription Label - ANS1 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 Durham Humphrey Amendment of 1951 - ANSDivided medications into OTC and prescription (legend) drugs Elements of a CDS Rx that an Rph can NOT change - ANS1. Patient's name 2. Name of medication 3. Prescriber's signature Establishments that may be Granted a Pharmacy Waiver Permit - ANSSpecialized services, ie: Home infusion Inpatient hospital Non-sterile compounding Sterile compounding Nuclear pharmacy Veterinary care Facilities that Require Pharmacy Permit - ANS1. 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 Faxed CDS Rx - ANSMay serve as the original rx for home infusion, comprehensive care, or hospice patient Food, Drug, and Cosmetic Act of 1938 - ANSRequired manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Generic Substitution - ANSRph 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 3. indicate generic name and manufacturer on label Permit Holder Requirements for Permanent Pharmacy Closure - ANS1. 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 Pharmacist Administered Vaccinations - ANSRph allowed to immunize: 9 years and older for flu 11-18 years: any CDC recommended vaccine with an rx from prescriber Adults: any vaccine recommended by CDC and for international travel per vaccine specific protocol Pharmacist Consultation in Assisted Living Facility and Comprehensive Care Facility Requirements - ANSAssisted 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 Pharmacy Intern Registration Renewal - ANSIntern registration is good for 2 years May be renewed one time only Pharmacy Intern Registration Requirements - ANSCurrently enrolled in and completed 1 year of pharmacy education or graduated from a pharmacy program Pharmacy Permit Expiration Dates - ANSRenewed every 2 years Expires May 31st on even years Pharmacy Quality Assurance Program Requirements - ANS1. Document periodic review (every 6 months) 2. Include analysis of delivery system 3. Identify high-alert meds 4. Maintain records for 2 years Pharmacy Technician Registration Renewal - ANSBiennial renewal, expires on the last day of birth month Must complete 20 hours of CE Pharmacy Technician Registration Requirements - ANSPass PTCB or ExCPT or: Complete training program approved by board that is no longer than 6 months in duration and includes 160 hours of work experience Pass an exam approved by the board 17 years or older High school grad or GED or currently enrolled in good standing State criminal history check (fingerprinting) Poison Prevention and Packaging Act of 1970 - ANSRequired 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 - ANSLaws 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 Prescription Expiration Dates - ANSRx 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 Record Requirements - ANSMost must be maintained 5 years Medicaid patients: 6 years Medicare patients: 10 years Prescription Refills - ANSNon-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 Pure Food and Drug Act of 1906 (Wiley Act) - ANSPrevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Records Required to be kept for Sterile Compounding - ANSAll records kept for at least 5 years: 1. Completed patient prescription records 2. Training and competency evaluation of employees in sterile prep procedures 3. Refrigerator/Freezer temps 4. Certification of sterile compounding environment, including ISO 5 stations and clean/ante rooms 5. Quality control logs (cleaning logs etc.) 6. Records documenting inspection for expired drugs/raw ingredients 7. Preparation records and pharmacist/tech sign offs 8. Media fill verification results Refilling a non-CDS rx with no refills - ANS1. Rph not able to reach MD 2. Medication is essential/necessary to prevent interruption in therapy 3. Rph judgement that interruption might produce undesirable consequence 4. Limited to a 14 day supply and prescriber must be notified within 72 hours of unauthorized refill Refusing to Fill - ANSA 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 Repackaging Bulk Containers to Unit Dose in the In Patient Setting: Requirements for Records - ANSLog should contain: 1. Drug name, strength, quantity 2. Manufacturer, lot number, expiry date 3. Hospital assigned lot number Reporting Lost/Stolen CDS - ANSMust reports to local police, MD BOP, DEA (via form 106), and MD DDC Reporting Lost/Stolen DEA Form 222 - ANSReport to local DEA office Required Information for a Valid CDS Rx - ANS1. Patient's full name and address