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A comprehensive overview of key concepts and regulations relevant to the kentucky mpje (multistate pharmacy jurisprudence examination). It covers a wide range of topics, including dispensing limitations, prescription requirements, record-keeping regulations, and pharmacy closure procedures. Particularly useful for pharmacy students preparing for the mpje, as it presents information in a concise and easy-to-understand format.
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What is corresponding responsibility - โ โ the pharmacist has equal liability for dispensing a prescription that would be dangerous to the patient. Optometrist dispensing , limitation - โ โ 72hour supply no refill, no C-II. Meds are diagnostic agents only May give epinephrine or diphenhydramine for anaphylactic reaction Physicians dispensing requirement - โ โ Doctor must be on premises Dispensing limited to the physician's patients. No more than 48h supply if CS can you use human product in animal? - โ โ Yes Can you use animal products on human? - โ โ No If your prescriber is dead or retired, what happen to the prescriptions? - โ โ ALL CS void, but legend drugs can be filled for a reasonable period until patients can find a new practitioner Drug samples - โ โ cannot be dispensed for profits addiction treatment physicians have special DEA - โ โ start with "X"
How many patients can one addiction doctor treat at one time? - โ โ 100 Addiction doctor can write for these meds - โ โ suboxone, subutex (buprenorphine) methadone must be admin on-site, no Rx. However, can dispense 72h supply for a hospitalized addict. Can you compound OTC? - โ โ No CE record how long do you keep them - โ โ regular CE 3 years HIV/AIDS: 10 years Intern ID card is good for - โ โ 6 years Change in PIC should notify board in.. - โ โ 14 calendar days Equipment - โ โ Class A balance + weight set Graduate 1-250mL Filter + funnel
Mortar + Pestle (glass, porcelain, or wedgewood) Spatula-steel and non-metallic Oinment slab or papers
Heating Unit, fridge
APRN meds that can be prescribed with 30 days no refill - โ โ Lorezepam, Clonazepam, Diazepam, Alprazolam, Carisoprodol (Soma), Hydrocodone containing product How long should collaborative care agreement be kept? - โ โ 5 years PHI and HIPAA record should be kept for - โ โ 6 years How many techs can a pharmacist supervise at a time. - โ โ law does not say so What does a pharmacy need to be a pharmacy... - โ โ A permit When does pharmacy permit expire? - โ โ 6/ Does using a common data base constitute a transfer? - โ โ No Pharmacy closure sign - โ โ the sign has to be there 30 days in advance Sign must be left in place for 30 more days after closure. What does the pharmacy closure sign have to say - โ โ Where prescription records have been transferred - exception for transfer of record less than 5 miles Who should you notice if closing a pharmacy - โ โ 15 days prior to Board, DEA, CHFS How long should you maintain the record if closing a pharmacy - โ โ 2 years
Involuntary closure - โ โ acute illness, death, natural disaster, bankruptcy, court or Board action written notice 5 days May maintain premises for up to 60 days Board may seize drugs if no sale made in 60 days Voluntary closure - โ โ Chronic illness Deviation from posted ours over 5 consecutive days If failure to resume normal operations within 60 days, KY board will close store and seize drugs. How long do you store the daily log? - โ โ 5 years Charitable pharmacy regulation - โ โ Only legend drug No control substance May not charge ANY fee may accept prescription legend drugs for distribution in unbroken original package Hospital pharmacy has to assigned a position called - โ โ Director of Pharmacy Service of pharmacist in a hospital - โ โ Should be ALL TIME. If pharmacy is not 24/7, there must be someone on call. Hospital pharmacy and P&T committee - โ โ A pharmacist must be a member of the P&T
Clinical Pharmacy specials rules - โ โ Must have PIC and all reference books, but exempt on equipments Policy and procedure manuals updated annually Physical address Any law governing clinical pharmacists? - โ โ No Hospice drug limitations - โ โ SWFI Heparin flush Flu, pneumonia vaccine diphenhydramine Inj. epinephrine inj. glucagon Emergency box in LTC facilities - โ โ Limited to 6 CS with written policy and procedurs Physician must order. Pharmacy should be notified 24h after box open. Physical Inventory at least monthly. DEA registered pharmacy employment limitation - โ โ cannot hire anyone has been convicted of a felony related to CS unless the DEA issues a waiver. Waivers are specific to each employer and each employee.
What kind of licenses do you need as drug manufacturers and wholesalers? - โ โ A CHFS-drug control license & DEA license- if handling CS Each location should have its own license. Manufacturers/wholesalers return limitaions - โ โ returns of damage, unsalable, recalls, can only be distributed to original manuf., 3rd party return processor, or reverse distributor Can a physician's agent prepare a Rx? - โ โ yes, except the signature Formulary compliance dispensing? - โ โ 1st...what the hack is this? prescriber notes "formular compliance approval", may be stamped on Rx blank Name of drug on the prescription bottle, not to label it, how - โ โ If practitioner indicates "Do Not Label" What should be on the prescribers Rx pads? - โ โ name, address, tel# of the prescribing physician DEA as well for CS Emergency 72h refills - โ โ No refill on Rx Prescirbers not readily available to authorize refills. A 72 hours supply can be dispensed. Has to be maintenance meds, with your judgment that such interruption will be detrimental to the patient
original number of refills authorized How long should you keep the transfer materials? - โ โ 5 years When do you need to use the Medicaid tamper resistant prescription blanks? - โ โ For all Medicaid (Not medicare) prescriptions. The 3 special functions of the Medicaid tamper resistant blanks - โ โ
but requirements are not required for telephone, oral, faxed, or electronic Rx Pharmacists' right to retain prescriptions - โ โ Pharmacist has the right to seize & retain a prescription reasonably suspected to be forged, altered, or unlawfully possessed. One must ascertain whether or not valid within a reasonable time. What is a prescription is unlawful, what do you need to do - โ โ report to authorities What if a drug does not have "RX ONLY" on a prescription drug bottle? - โ โ The drug is misbranded. What is a adulterated drug? - โ โ It is filthy, putrid, decomposed, contaminated (drug or container), poisonous, wrong strength.
Definition of a misbranded drug - โ โ A drug that its labeling is false or misleading. A drug that is dangerous to the health when used as prescribed on the label APAP 500mg take 1 to 2 tabs PO Q3-4H PRN - โ โ Misbranded. Health issue max at 16 x 500mg table a day = >3000mg guideline = liver toxicity What do you do with misbranded or adulterated drug? - โ โ Must be quarantined, affixed with a tag indicating notice that the drug is adulterated or misbranded -- such drugs ar eto be destroyed at the expense of the claimant (manufacturer) Expiration date of repackaged drug - โ โ Except if the expiration date on the original packaging is less than 1 year Unit dose expiration date - โ โ Beyond Use date is either 6 months or 25% of the time remaining (which ever is shorter) The only drug that does not need safety cap - โ โ Nitroglycerin Who can or cannot request non-safety cap? - โ โ Patients only, not physicians. But physician can request non safety cap on a single prescription. Pharmacy can only get return of unused-unopened-sealed bottles for re-sale, but what are the limitations? - โ โ Must be within 14 days, and also does not require refrigeration. Can FDA issue a recall? - โ โ NO, they can only request it.
How many times can you be a president of the board? - โ โ 2 years (2 times) How many times should the board members meet? - โ โ 4 times Four members constitute a ___ - โ โ Quorum The board is authorized to: - โ โ *approve approved college of pharmacy (No such thing as accredited) *employ an executive director. The executive director must be a pharmacist etc. How to file complaints to Board - โ โ Oral or written Steps of the board handling complain - โ โ 1. Agreed order
Preceptor's license - โ โ The license will be marked "Preceptor" Name of the background check - โ โ HB To become a pharmacist in KY, you have to register with... - โ โ KASPER CPE monitor Continuing education requirements in KY - โ โ 15 hours (1.5 CEU) per year Can you carry over the CE? - โ โ No What else for CE in KY? - โ โ every 10 years, there should be a ONE hour CE about HIV/AIDS, and it must be approved by the Cabinet for Health and Family Services (CHFS) CHFS - โ โ Cabinet for Health and Family Services Time period for CE - โ โ 1/1-12/ Can you obtain all 1500 hours during the 4th year only? - โ โ Yes Up to how many hours of internship can be related to the work/research - โ โ 400 Can graduate intern do the final verification? - โ โ No How long do you need to practice before becoming a preceptor? - โ โ 1 year How many students can one preceptor supervise at the same time - โ โ only 1 student at a time, but he/she can precept any number of students.
Supervision of pharm tech vs. cert. pharm tech - โ โ pharm tech: immediate supervision Cert. pharm tech: general supervision Certified pharm tech power - โ โ Certify med carts, inititate or receive refill authorizations, receive diagnostic orders in a nuclear pharmacy. No new Rx Accutane and generics special requirement - โ โ 1. Patient and prescribers must be enrolled in iPledge program
Pamphlet for generic med - โ โ You have to have the CHFS generic drug pamphlet available to patients, but not required to give it to them. What is a negative formulary state? - โ โ The Board is authorized to prepare a nonequivalent drug formulary of drugs for which there are no equivalent drug products and which should not be interchanged. HB1 requirement - โ โ Patients have to be seen by prescriber for CS presciptions. C-I drug criteria - โ โ High potential for abuse No accepted medical use C-II criteria - โ โ High potential for abuse Accepted medical use Abuse may lead to severe dependence C-III criteria - โ โ Potential for abuse less then C-I or C-II Accepted medical use Abuse may lead to moderate or low physical or high psychological dependence C-IV Criteria - โ โ Low potential for abuse relative to C-III Accepted medical use Abuse may lead to limited physical or psychological abuse relative to C- III C-V Criteria - โ โ Accepted medical use
Balance must be dispensed within 60 days The patient then can receive multiple partial fills C-III to C-V validility - โ โ 180 days (6 months) Storage of C-III to C-V prescriptions - โ โ Can be together or separate from regular prescription. IF together, must be readily retrievable. minimum BMI requirement for anorexiants for a C-IV anorectic - โ โ 27 if no comorbidities 25 if co-morbidities Belviq & Osymia BMI requirement - โ โ 30 27 if has co-morbidities IS BMI required on the prescription for those weight loss drugs? - โ โ No CS prescriptions paper requirement - โ โ 1. A latent void pattern in
What if a physician write 2 meds on a CS Rx? - โ โ Don't fill the control, fill the non-control From 222 copies... - โ โ Brown (supplier - card boxes!) Green copy (DEA - statue of liberty) Blue copy (retained at pharmacy - AOC home team color) If a DEA 222 is voided or defective - โ โ must be retained If a DEA 222 is lost or stolen - โ โ must be reported to DEA and Board of Pharmacy DEA form 106 - โ โ reports theft of CS Under HB1 theft or loss must now also be reported to Board DEA form 41 - โ โ form for outdated (expired) drugs Under federal law, records of all records should be retained for - โ โ 2 years In KY, how long should you retain CS records? - โ โ C-II: 5 years C-III to C-V: 2 yeras Controlled substance for animals, requirement - โ โ Must list owner's name, the species of the animal You should retain the purchase record of control substance, what to keep - โ โ C-II: Invoice and DEA 222 blue copy. On these, there must be listed the seller and buyers names, addresses, and DEA numbers, the date of actual receipt of the drugs , quantity, drug name, strength, form.