Multistate Pharmacy Jurisprudence Examination (MPJE) MPJE NY COMPREHENSIVE STUDY GUIDE

Multistate Pharmacy Jurisprudence Examination (MPJE) MPJE NY COMPREHENSIVE STUDY GUIDE 2022 [A+] 30 days Correct Answer: Waiting period for MPJE after failing include substuting or selecting a different drug which differs from that initially prescribed by pt's physician unless substitution is authorized in order or protocol. Correct Answer: Adjusting drug regimen shall not... IF authorized in protocol Correct Answer: RPH can make changes to pt's drug therapy may be necessary in drug therapy management. Correct Answer: Ordering or performing route patient monitoring fxns Judgment of the MD shall prevail Correct Answer: If MD disagrees with professional judgment of RPH employed with same facility where RPH is employed/affiliated. Correct Answer: MD part of agreement/protocol authorizing collaborative drug therapy management must be pt or pt's rep consents IN WRITING to such management. Correct Answer: Cannot use collab drug therapy management if Info on immediate container (must be on outside wrapper if exists) Correct Answer: Label Includes all info ON or accompanying drug/device Correct Answer: Labeling Labeling = misleading or fails to reveal facts. Like misleading advertising. Correct Answer: Misbranding Instruments, apparatus, contrivances including: components, parts, accessories intended: ---For use in diagnosis, cure, mitgation, tx, prevention of dx in man or animals; or ---To affect the structure or any fxn of the body of man or animals Correct Answer: Device A pt specific order or non-pt specific regimen prescribed or ordered by MD or NP who has practice site in the county. Correct Answer: Administer Created, recorded, or stored by electornic means, issued with electronic signature Correct Answer: Electronic RX If created electronically must be transmitted from MD to RPH by FAX --> MUST BE MANUALLY SIGNED. Correct Answer: Original hard copy RX Electronic sound/symbol/process, attached to electornic RX, executed by person with intent to sign RX. Correct Answer: Electronic Signature -Issued to student enrolled in last 2 years of registered program in pharmacy. -Intern may practice as RPH under supervision of RPH -Must be posted at site of employment -Expires 5 years from date of issue -May be renewed ONCE for a period not to exceed TWO YEARS with permission from BOP -Must be relinquished if not licensed within this time. Correct Answer: Limited Permits - Pharmacy Interns - permits employments to pharm interns -Physicians - MD, DO -Physician assistants (RPA) -Podiatrists (DPM) -Dentists (DMD, DDS) -Vets (DVM) -Optometrists (O.D) -Nurse Practitioners, Certified (CNP) -Mid-Wives (F) Correct Answer: Authorized prescribers XXXXX-XXXX-XX 1) Label code, assigned by FDA, the manufacturer. 2) Product code - strength, dosage form, and formulation 3) Package code - package size Correct Answer: NDC 1) Tamper with interstate commerce with intent to injure person 2) Taint with intent to injure business 3) False info 4) Conspire to tamper Correct Answer: Anti-tampering act Hx: Passed by congress in 1984 d/t deaths bc of OTC meds contaminated with cyanide. Tamper resistant package - has indicators or barriers to entry - if breached/missing - expect to show visible evidence that tampering occurred. 1) Distinctive by design, cant be duplicated. 2) Use 1 or more indicator or barrier to entry that employ a characteristic. Correct Answer: Anti-Tampering Must alert consumers of the specific tamper resistant feature of package. Correct Answer: OTC Labeling Tamper Resistant Pg 12 for list. Cannot reuse any part of CRC in NYS. May reuse glass if new safety closure used. CPSC - consumer product safety commission Correct Answer: Drugs EXEMPT from PPA 1) APAP 2) ASA / Ibuprofen / ketoprofen / naproxen 3) Dibucaine 4) Diphenhydramine 5) Ethylene glycol > 10% 6) Glue removers containing acetonitrile 7) Human rx drugs 8) Lidocaine 9) Loperamide 10) Methyl salicylate liq > 5% 11) Methyl alcohol 12) Mouthwash w/ 3g or more of ethanol per pckage 13) Perm wave neutralizers w/ Na bromate or K bromate 14) Petroleum distillates Can market one size container w/o cap if it states: for households without young children. Correct Answer: OTC drugs that require CRC -This package is for households w/o young kids -Package not child resistant Correct Answer: If package not child resistant must state: -Pt can do req for individual rx or do blanket waiver for all -MD can only do Non-CRP for one at a time, no blanke. ***MUST DOCUMENT WAIVER REQUESTS. Correct Answer: CRC Waivers All non-rx drug products -Contact lens, tabs -Cosmetic liquid oral hygiene products -Cosmetic vaginal products Correct Answer: MUST HAVE Tamper-resistant seals OTC -Derms -Dentrifrices -Insulin -Throat lozenges -OTC administered by HCP in hospitals -OTCs in vending machines -Prodts via mail, package delivery service etc Correct Answer: Exceptions for tamper-res for OTC senior adult use effectiveness Correct Answer: SAUE 1) Meds must be in CRC 2) Bulk packaging to be repackaged by RPH doesnt have to be in special packaging 3) Unit packaging from manu must comply with CRC Correct Answer: Manu's packaging Must document waivers, don't need to have sig, pt can say it orally. Correct Answer: Waiver for CRC 1) Proper storage / handling of drugs. 2) Establish maintenance of records 3) Prohibits interstate commerce unless registered with shipping state 4) Bans reimportation of Rx Drugs (except same manu) 5) Bans sale/trade/purchase of samples. 6) Bans traffic in counterfeiting drug coupons 7) Prohibits resale of rx drugs by hospital for drugs purchased at special prices 8) Mandates storage/records of drug samples 9) MD's request for samples in writing 10) Criminal and civil penalties Correct Answer: Prescription Drug Marketing Act Only practitioners can receive. Pharmacies can receive if requested by practitioner. Written request needed: 1) Name, add, professional designation, sig of MD 2) drug name, quantity, and manu 3) date. ***Manu's must keep ANNUAL inventory. Must keep records for THREE years. Correct Answer: Samples -Remove products from market thats: 1) Misbranded. 2) Adulterated. 3) threaten consumer safety. Correct Answer: Drug Recall Class I: Cause serious adverse health consequences/death. Class 2: Cause temp or medically reverisble adverse health consquences. Class 3: Not likely to cause adverse health probs Correct Answer: Recall classifications