MPJE Exam

MPJE 2024 DEAform 224 renew every? - new pharmacy registration to dispense controlled substances (application for new registration) - pharmacy registration is renewed every 3 years (renewal registration form DEA form 224a - chain=224b) - registration kept onsite - issued by attorney gen. 3 exceptions for registration for dispensing controlled substances - employees, contract carrier, ultimate user who has to obtain a registration as a chemical distributor? who is exempt? what are the drugs listed here? - -wholesale distribution -retail pharmacies registered for controlled substances and retail distributors who sales are for personal use are below threshold quantities -ephedrine,pseudoephedrine, phenylprolanolamine (PPA), and ephedrine combos (List 1 chemicals) not to exceed 3.6g/day or 9g/month DEA form 510 - DEA chemical distributor registration the attorney general can suspend or revoke DEA registration with what findings - falsified application, felony conviction involving controlled substances or list 1 chemicals, license suspended,revoked or denied, excluded from medicare/medicaid, act inconsistant with public interest 4 ways to get rid of controlled substances records kept for how long - -transfer to customer, dispensing rx -destruction -transfer to another DEA registrant (dr,back to distributor or manufacturer) -surrender to DEA/law enforcement 2 years, readily available (5yrs UCSA) how to transfer C2 substances to another DEA registrant, pharmacy, manuf? C3-C5? five percent rule? - receiving registrant must issue Form 222 (dr brings 222 form into the pharmacy) - also need if transfering ownership of pharmacy w/ inventory- notify DEA of transfer 14 PT - keep records for 2 years -just need documentation with drug name, dosage form, strength, quant, date and name, address, DEA number of those involved note:if transfering 5% of yearly sold controlled than need to register as a distributor!!! (five percent rule) DEA form 41 - form submitted to the special agent in charge (3 copies) that list controlled substances desiring to dispose of - form needed to report disposal or breakage/spillage 4 ways controlled substances can be destroyed - auth by special agent to do one of the following -transfer to person registered -delivery to an agent -destruction in presence of an agent -another means determined by agent (per UCSA:maintain records for 5 yrs) DEA states schedule 2,3,4,5 should be... - in a locked cabinet or dispersed in non-controlled stock to deter theft. electronic alarm recommended DEA from 106 - report of theft or significant loss of controlled substances -notify local police and DEA w/in 1 day if determined than submit form -do not use to report miscounts/adjustments/ breakage/spillage -if lost in transit supplier reports, if pharmacy signs for it and than notices it was lost in transit the pharmacy has to report according to DEA how long must records be maintained for controlled substances? what records must be maintained? C2 note - -2 years -used and unused 222s (or elec equiv), power of attoney authorization, receipts and invoices for C3-5, all inventory records or CSs, records of CSs distributed/dispensed, form 106, form 41, records of transfers between pharmacies, dea registrations certificate, self certification and log book for meth epidemic act -C2 records must be maintained seperately pure food and drug act - no adulteration, no misbranding - didnt account for efficacy or safety or ingredients harrison narcotic act - containers of narcs had to have tax stamps -tracking of narcs started food drug and cosmetic act 1938 - -saftey now tested before approved (not efficacy yet) -expanded definitions of adultered and misbranded - directions for use, warning -extended to cosmetics durham and humphrey ammendment 1951 - seperated Rx from OTC -can Rx by oral or written -can do refills -directions for use on OTC, information for use on Rx - transfered to product pt sheet kefauver-harris ammendment 1962 *** - -now you have to test for efficacy -DESI ( tested for efficacy) PT 1938 grandfathered. -GMP started -NDA started controlled substance act 1970 - DEA started and registrations drugs put into schdules poison prevent packaging act - child proof or OTC tamper proof to prevent poisonings excep:SL,dr can state for 1 rx, pt can blanket statement (document) orphan drug act - tax relief to manufacture drugs for rare diseases drug price competition act - aka hatch waxman ammendment -ANDA -accelerated drug approval for generics - only test equivalency prescription drug marketing act PDMA - drug pedigrees federal standards for storage, dist, recordkeeping or Rx drugs "drug diversion act" -bans re-importation prescription drug user fee act (PDUFA) - fees on manuf and prod to go to FDA nutrional labeling education act NLEA - prevented disease prevention claims in food labels - dietary supplements upset dietary supplement and health education act (DSHEA) - DS no longer food - not subject to testing by FDA -4 things can state: moa,how it affects the body, how it benefits a deficiency, general well being -can not claim to help disease - but can have marketing in store as long as not manuf or store made -label must state has not been tested -FDA can now pull unsafe products - manuf has to submit ADRs best pharmaceutical for children act - voluntary incentive - increase patent length if test on kids pediatric research equity act - fda can now req pediatric testing drug - recognized by USP, or NF or other - used to treat,cure,prevent,diagnose a disease - affects structure of the body new drug - not safe for condition stated or as labeling states prescription drug - habit forming or could could toxicity or harmful affect to public - limited by approved application - not safe for use unless under the care of a dr OTC drug - safe and effective for use, must comply to GMP, must have adequate directions for use - written in layperson terms NDA - new drug application - needed before marketing ANDA - abbreviated new drug app - needed before marketing of a generic adulterated - prepared,packaged or held in unsanitary not following GMP conatiner leeches poison or deleterious unsafe color added varies from official compendia otc drug not in tamper-resistant misbranded - label is false/misleading label does not state name place of manuf wrong quantity info not prominent or missing something generic not less than 1/2 size of brand not following compendia standards drug package is misleading or imitative insulin or aB not batch certified which FDA recall is the most serious - class 1 recall - reasonable probability use will cause serious adverse health conseq or death drug development stages - animal, IND (to ship), phase 1 (small,healthy to determine preferred admin route and safe dosage), phase 2 (larger w/ event to test efficacy), phase 3 (larger, multicenter, strict criteria safety and efficacy, risk vs benefit), NDA, phase 4 (post marketing), ANDA (for generic or new indic) OBRA 90 - omnibus budget recon. act 1990 indirect way for federal gov. to regulate pharmacy - cut costs 3 components 1-rebate programs. drugs provided to state medicaid programs at "best price" or diff between AMP and best price rebate (340B) 2-demonstration projects - showed cost savings based on DURs 3-DURs (retrospective,educational,prospective) HIPAA - health ins portability and accountability act congress madated -electronic standards to simplify transfers -development of privacy standards for electronic data (privacy rule) pertaining to protected health info (PHI - indiv. indentifiable health info) -entities must get pt consent to use PHI for treatment, payment. -newly modified (HITECH act) which reqs pts be notified if breach (refill reminders ok per hipaa) medicare - 65 or certain disabilites part A: financing for hospital part B: like regular ins, monthly charge part D: voluntary Rx coverage, monthly fee, deductible and dounut hole (), also allows for MTM