Pharmacist Licensure and Pharmacy Regulations in Massachusetts, Exams of Pharmacology

Download Pharmacist Licensure and Pharmacy Regulations in Massachusetts and more Exams Pharmacology in PDF only on Docsity! MA MPJE EXAM 2024/2025 WITH VERIFIED COMPLETE SOLUTIONS |GRADED A+ How to categorize the stability of non-sterile compounded products? Beyond Use Dates (BUD) based on non-sterile formulation categories - non-water containing liq: BUD <6 months OR earliest of any ingredient - Water containing liq form(PO): 2-8C storage. BUD max 14 days OR earliest ingredient - water containing topicals/mucosal/ semisolid forms MUST be given BUD max 30 days OR earliest ingredient date - can assign longer BUD with proper citations and evidence How many Board members? 13 Pharmacist Board Members - Requirements 8 Pharmacists each with 7 consecutive years in MA. 2 independent 2 chain 1 hospital 1 long-term care 1 sterile compounding 1 academia Non- pharmacist Board members and requirements 1 licensed pharmacy technician 1 public representative with health care service delivery, administration or consumer advocacy exp 1 physician 1 nurse 1 expert in patient safety or quality improvement What entities is the Board under? Department of Public Health (DPH) -> Bureau of Health Professions Licensure (BHPL) -> Board of Registration in Pharmacy Who chairs the Board of Pharmacy? Current member of the board of pharmacy will serve for 1 year as president. Max can serve 1 year as president and 1 year secretary per term of membership When is the Board of Pharmacy President and Secretary elected? Board meets on the 1st Tuesday of December annually. How are the Board members selected? Governor of Massachusetts appoints the members How long do the Board Members serve? 1 term = 3 years. May serve 2 consecutive years and eligible for reappointment after 1 full year of NOT serving on board How often does the Board convene? Annual meetings on: 1st Tuesday of Jan, May and October. Election in December. Additional prn determined by members. Who can attend Board of Pharmacy meetings? NO. Minimum Intern hours needed and how to obtain them? 1500 hours A: 1000 via pharmacy related settings and 500 via internships in settings (manufacturing, demonstration prohects, clinical pharmacy or industy/analytical B: 1500 via experimental pharmacy experience as graduate from ACPE SOP. Degree/ Education required? US: Doctor of Pharmacy from accredited SOP Foreign: Graduate from non-accredited SOP or foreign SOP Examination requirements for new graduates? MPJE, NAPLEX Examination requirements for Transfer? MPJE NAPLEX Scores sent by NABP via Transfer of Pharmacist Licensure Application (TPL) Examination requirements for foreign graduates? MPJE NAPLEX Overall licensure application documents needed? Mass BOP uses PCS Complete application has: - recent passport size photo - Copy of Birth certificate, valid passport OR DL - name change? written notification to Board/Board designee - Payment - notarized signature to ok background check Additional application requirements for new pharmacist? Verification of grafuation form. MUST be filled out by school registrar and sealed in envelope to be included in overall application envelope Additional application requirments for Transfer/reciprocity? Transfer: - VOG - Request for NABP to send NAPLEX score to MA BOP prior to taking exam Reciprocity: Official NABP application for transfer of Pharmacist Licensure Additional application requirements for foreign pharmacy graduates - Official copy of FPGEC certification from NABP - VOG What is the reinstatement process? If the license has been inactive for x amount of time, then they must meet the specific conditions and any additional stipulations determined by BOP case by case What is the reinstatement process if license has been inactive NOT due to revocation/suspension for greater than 60 days but less than 2 years Apply for renewal Reinstatement process if inactive due to revocation/suspension for 6 months to 2 years? Apply for renewal AND retake/pass MPJE Reinstatemnet process if inactive NOT due to recovation/suspension for more than 2 years? Apply for renewal AND retake/pass MPJE Reinstatement process if inactive due to revocation/suspension for more than 2 years Apply for renewal AND retake/pass MPJE. May need to retake/pass NAPLEX prior to renewal process Current Enrollment/Good Standing Requirements for New pharmacy intern? Must be enrolled in accredited SOP PharmD programs. May apply at completion of 2nd year (if 6 year program) - allows for students to apply during transition period of undergrate coursework and beginning professional curriculum Enrollment/good standing requiremnts for foreign gradutes intern license? Must have current authorization from NABP to sit for the Foreign Pharmacy Graduate Equivalency Examination Are preceptors required for the pharmacy intern license? YES. Must include information regarding primary preceptor and facility hours are obtained from. If preceptor changes must submit form to board of such change. Exceptions: If intern does NOT intend to work while licenesed as intern. Pharmacy intern license renewal period? 5 years. (can't reapply but can apply for license extension) Does a pharmacy technician require license/registration? YES. Application required Who can apply for a pharmacy technician license? Min: 18 yo AND one of following: - Licensed in another state - Certification conferred by board approved certifying body - Pass BOP approved exam after either 500 training hours as tech trainee OR BOP approved training program (ASHP accredidation, US Armed services/public health, BOP approved program with min 120 hr theoretical and 120 practical instruction Application fee for pharmacy technician? 150 Pharmacy technician application requirements - Verification of education status (enrolled/graduated HS) - Verification of completed training hours/program - passed board of pharmacy approved assessment Pharmacy technician renewal period? Every 2 years on BDAY What is a Certified Pharmacy Technician? A registered pharmacy technician who is certified by either PTCB or ExCPT. If certification lapses: limited to duties and responsibitlies of a pharmacy technician, use pharmacy technician title and be counted as pharmacy technician in supervisory ratios Renewal period for a certified pharmacy technician? Every 2 years on BDAY Who can apply for a pharmacy technician in training license? min: 16 yo, enrolled/graduated HS Eligible for tech license? 18yo AND 500 hr Required to pursue tech license? 18yo AND 1500h/1 year employement. Can submit application for tech license up to 30 days before day of birth (18y) if all other requirements are met (1500hr/1 year employment) Extension can be granted by BOP Pharmacy technician in trainee application requirements? - info of current education status (HS) - verification information of all current standing licenses - recent passport size photo with signature on back - signature certifying BOP to run background check Specific requirements on who can access the Pharmacy? No access without pharmacist within the pharmacist EXCEPT followiing the issue of an administrative inspection warrant When/who can enter the Pharmacy without a Pharmacist? What are the additional pharmacy sign requirements other than counseling, hours, and PIC? Reasonable and highly observated spot indicating pharmacy inside. If dispensing C2-5, then must sell prescription lock boxes at each store loaction (EXCEPT institution pharmacies or pharmacy department). Sign: 4" by 5". "Lock boxes for securing your prescription medication are available at this pharmacy" When must the BOP be notified of any changes to ownership of a pharmacy? Within 30 days What information must be included when informing BOP of pharmacy owndership changes? - full name of new owner - attached official bill of sale If transferred/purchased by corporation? - Copy of corps articiles of oranized (signed by MA secretary) - copy of corps foreign corp certificate (if out of state) Statement of each officer/directors name, address and position - D/b/a (doing business as) - Private? name and address of stockholders with stock type and amount When must you notify the BOP of any changes to the PIC (or MOR) generally? - within 10 days Included information: - Cs inventory signed by both outgoing and incoming MOR - outgoing unable? staff RPh may be authorized to sign off if BOP was notified. - Pharmacy permit/certificate of fitness (if applicable) - required fees (525) What is expected if the MOR expected to be absent from the position for greater than 30 days? - must name a Board-licensed pharmacist Interim Manager prior to planned absence OR within 5 calendar days of any unplanned absence. - Interim Manager fulfills all duties of MOR during absence - Immediately notify BOP of Interim Manager name and license # - Must perform a controlled substance inventory and signed by both present MOR and Interim Manager. If present is not present lol another licensed RPh must do so. - DO NOT submit this inventory to BOP, but maintain in records. MAX allowed only when absolutely necessary: Another MOR from another BOP licensed MA pharmacy may act as Interim Manager for 1 other pharmacy. MAx 100 days. - ID pharmacy and license # of Interim MOR's original pharmacy. Send in email to BOP. Absence >100 days? New application for change in MOR must be submitted. When should you notify the BOP of changes to pharmacy address? In advance of address change. New application to BOP and return all previously issued permit (Permit to operate, CS regstration, certificate of fitness) What is a certificate of fitness? Permits the pharmacy to alcohol for USP and National Formulary compounding an also sell alcohol strictly for medical purposes (not beverage consumption) What type of prescription balance is needed for the pharmacy? The balance must be capable of weighing 13 grams and is tested/sealed annually. What equiptment resources must a pharmacy maintain? - Current version of MA List of Interchangeable Drugs (electronic ok), + orange book and additional/exception list - Compendia current version (electronic ok) with quarterly updates (4 x year) - current copy of board regulations - USP required equipment - appropriate sanitary appliances- suitable sink - logbook for OTC Cs sales - logbook for alcohol sales(when purchased!) , including signatures of purchasers (if applicable) When can an automated dispensing device be used for controlled substances? Who can use them? Healthcare facilities may use automated dispensing devices for controlled substanecs (C3-5) as authorized by held license. - full name of new owner - attached official bill of sale Corp? - copy of corps articles of organized - copy of corps foreign corp - statement of each officer/directors name, address and position - d/b/a -Private? Name and addresses of stockholders with stock type and amount Any changes in PIC/MOR reporting requirements. Any application or fees required for change in ownership? Yes for formal application and fee is 525 How soon should you notify the BOP of any changes to ownership/manamgent of pharmacy? Must notify BOP within 10 days What is the RPh to tech staffing ratio? 1 RPh to max 2 technicians 1:3 if (1/3) is certified or intern 1:4 if (2/4) is certified or intern FYI: per 8/8/21 COVID practice updates up to 1:6 ratio at places providing vaccinations and 3/6 are interns/certified All pharmacies compounding (sterile or non-sterile) need to provide? Must include telephone for communication between commonwealth patients and a pharmacist employed by the pharmacy woh has access to patient records - staffed during regular business hours and not less thant 56 hours/week - # to drugs container - NOT APPLICABLE to instutional pharmacy IF sterile drug preparation is patient specific What are the requirements for ALL retail pharmacies engaged in complex non-sterile compounding? - Compounded drug preparation is consistent with USP 795 description - proper training - follow all stipulations require of a traditional pharmacy What are the requirements for pharmacies engaged in sterile compounding? - "Clean room" +BOP approval of room MUST be visible to public on pharmacie's premises. Clean room: - min 72 sq ft working space - closed on all sides except door/opening to pass materials - laminar flow hoods with vertical/horizontal air flow - HEPA filters and prefilters (BOP certified annually completed prior to start of operations) - continuous positive pressure UNLESS hood is self-venting - located directly adjacent to prescription are What are the requirements for pharmacies that commpound with an institution (sterile and complex non-sterile)? - special institutional sterile compounding license (for on premise compounding, CANNOT distribute out of facility) - Renew license annually - Annual report with all compounded mediations MUST be submitted What are the restrictions on compounding WITHOUT a patient specific prescription? MUST BE PATIENT SPECIFIC!!!!! Accountability documentation - physicial doc validating lot # and expiration dates of BUD of drugs/preparation prior to dispensing. Includes EVIDENCE OF RECEIPT Purpose: - faciliate tracing - ID individual, pharmay tech, or automated device that compounded AND - ID rx order that generated the compounding order How to decide the stability of compounded sterile products? BUD - according to USP or Board policy, whichever is stricter