NY State MPJE Exam With accurate solution 2023

NY State MPJE Exam With accurate solution 2023 Who are the Board members? - - 13 total members - 9 pharmacists licensed for at least 5 years in NYS - 2 public representatives - 2 registered pharmacy techs - An executive secretary appointed by the Board of Regents (NOT technically part of the Board) Who Chairs the Board? - A chairman and vice-chairman are elected annually by the board of pharmacy members How are Board Members selected? - Appointed by the regents based on the recommendation of the commissioner How long do Board Members serve? - 5 year terms How often does the Board convene? - No set law but historically 4 times a year How often is the license renewal? - Every 3 years How many CE hours are required for pharmacist license renewal? - Minimum 45 hours every 3 years What are the special CE requirements for license renewal? - - No more than 22 hours can be self-study - Live-CE does not technically have a minimum buts historically 23 hours at least - At least 3 of your CE hours must be on "reducing med errors" - You must retain your CE records for at least 6 years How many intern hours are required for pharmacist license? - - If in PharmD program, no additional hours - If BPharm, must have 1040 intern hours How long does an intern license (permit) last? - - 5 years - must be displayed conspicuously in pharmacy of employment - Can perform all functions delegated to pharmacists under supervision How are pharmacy technicians licensed? - - The term "technician" is not recognized in NY - Referred to as "unlicensed assistants" - No requirements to become an unlicensed assistant Who can access the inside of a pharmacy? - - Every pharmacy must be under the immediate supervision and management of a licensed pharmacist at all hours when open for business - State Board of Pharmacy, department of education shall have the right to enter any pharmacy at reasonable times for inspection What is the minimum square footage for a pharmacy? - 300 square feet with at least 100 of that 300 square feet dedicated for manufacturing, compounding, and dispensing What are the security system requirements for a pharmacy? - The walls of a pharmacy must be floor or ceiling, or at least 9'6" high What are the storage requirements for prescription hard copies? - - C2s separate, C3-5s separate, non-controls separate - Storage for scripts do NOT have to be locked but the system in place shall provide adequate safeguards against improper manipulation or alteration of stored records What are the storage requirements for actual medications including controls? - - Only requirement for drug storage is adequate heating and ventilation to safeguard purity and potency of drugs - Controlled medications do NOT have to be locked and can be dispersed throughout the pharmacy How long must prescription hard copies be kept on site? - Must be on premises readily available for 5 years How long do you have to notify the Board of Pharmacy of a change in ownership of the pharmacy? - Within 30 days of the change How long do you have to notify the Board of Pharmacy of a change to the pharmacist in charge (PIC)? - Owner must notify Board within 7 days of change How long do you have to notify the Board of Pharmacy of a change in address? - At least 30 days prior to the expected relocation How long do you have to notify the Board of Pharmacy of damage by fire/flood/disaster? - Notify board within 48 hours What type of prescription balance is required? - Class A Balance (6 mg) and metric weights if needed What other medical equipment is required in a pharmacy? - - Devices capable of measuring volumes from 0.1 mL to 500 mL - mortar and pestle - Refrigerator with a thermostat and capable of temperatures of 2 to -8 degrees Celsius limited to only the storage of drugs - A copy of laws, rules, and regulations governing the practice of pharmacy in NY - Hot and cold running water in compounding and dispensing area Must an RPh be on-site for access to the pharmacy? - YES How does mail order work in NY? (long answer, confusing) - - Considered "off-premises delivery" - Out of state must register as nonresident establishment - Must be licensed and/or registered with their home state in order to seek registration in NYS - Must provide a toll-free number during normal business hours and at least 40 hours/week for communication between the patient and pharmacist - Must designate a resident agent in NYS (basically someone to receive notice of lawsuits) What are the exemption for out of state mail order pharmacies? - EXEMPTION: NYS may grant exceptions to registration requirements for nonresident establishments that restricts its sale or dispensing of drugs to residents on this state to "isolated transactions" (600 or fewer prescriptions/year for pharmacies or $10,000 in sale for manufacturers or wholesalers in New York; isolated transactions are transactions necessary to protect the public health by addressing emergency shortage of drug and/or device in New York) Do you have to be an RPh to own a pharmacy? - NO For the PIC, how many hours are the required to work? - Must be full time (30 hours minimum) OR a majority of the hours of operation What are the signage requirements for a pharmacy? - - Sign bearing full name of owner shall be displayed prominently on exterior of premises - If located in multi-tenanted structure (mall), must be in directory and immediate entrance to pharmacy - The registration itself must be conspicuously displayed at all times inside the pharmacy - If PIC changes, owner must apply for amended registration and attach to original registration What is the RPh to technician ratio? - RECENTLY CHANGED: Up to 4 unlicensed persons may assist a pharmacist with filling prescriptions (cashiers NOT included) What is the RPH to intern ratio? - Each preceptor pharmacist can supervise not more than 1-full time intern or 2-part time intern (interns do NOT count toward the RPh to tech ratio) How many prescriptions must be dispensed per intern? - 5000 prescriptions must be dispensed annually per intern What type of facility licensure is required for general and sterile compounding? - - No licensure for non-sterile compounding - Sterile compounding: if facility does this, considered an outsourcing facility What does the FDC Act state regarding outsourcing facilities and dispensing? - Any outsourcing facility may NOT dispense or distribute drugs to any person pursuant to a prescription UNLESS that facility is also registered as a pharmacy How frequently must an outsourcing facility report to the state board? - - A report must be submitted to the executive secretary of the state board every 6 months - Report must identify all drugs compounded in the 6 month period What are the restrictions on compounding without a prescription? - - Must be pursuant to a patient specific order - Exception is compounding in limited quantities before the receipt of a valid prescription order for such individual patient and is based on the history of the licensed pharmacist receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship - If you have an established history of compounding this drug for a patient (refills), you can do small amounts before you get the actual RX Which drugs are required to be behind the counter? - Products containing ephedrine, pseudoephedrine, or phenylpropanolamine What are the dispensing requirements for behind the counter drugs? - - Must maintain a written or electronic list (logbook) that identifies the products by name, quantity sold, names and addresses of purchasers, and date and time of sales, and signature - ID of person required at purchase - Must maintain records for at least 2 years What are the max quantities for behind the counter drugs? - - 3.6 g per day AND 9 g per 30 days - If through mail order, only allowed 7.5 g per 30 days Can syringes be dispensed without a prescription? - - Without prescription, a registered provider can dispense up to 10 syringes at a time to a person 18 or older, with a safety insert containing information on proper use of syringes/needles - Pharmacies cannot advertise the availability of syringes without RX, must be kept in a manner not available to the public (behind the counter) - No logging requirement, but voluntary submission encouraged What are the rules for prescription syringes? - - Oral prescriptions are allowed for syringes - Prescriptions valid for 2 years in NYS, and can be refilled up to the number of times specifically authorized by prescriber - One authorized refill can be transferred to another pharmacy How frequently must a pharmacist renew their immunization license? - Every 3 years What age groups and associated vaccines are pharmacists allowed to administer? - - 18 and older: influenza, tetanus/diptheria/pertussis, acute herpes zoster, meningococcal, pneumococcal - 2 - 18 yo: influenza Can pharmacists administer medications? - If immunization certified, pharmacists can administer emergency treatment of anaphylaxis to patients 18 and older (epi) What are the rules for dispensing PrEP medications? - Pharmacists are able to dispense up to a 7 day supply of HIV PEP drugs for the purpose of preventing HIV infection in persons who have potentially been exposed to HIV pursuant to a non-patient specific order and protocol