NY MPJE EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS, Exams of Nursing

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NY MPJE EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS CSA - Precise Answer ✔✔Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act - Precise Answer ✔✔Sets child- resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA - Precise Answer ✔✔set by the department of health and human services CMEA - Precise Answer ✔✔Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act - Precise Answer ✔✔included the ANDA approval process for generic drugs includes review of product's chemistry, manufacturing controls, labeling (does not include pre-clinical animal studies and clinical studies with human subjects; uses bioequivalency analysis instead of bioavailability data) FDC Act - Precise Answer ✔✔Food Drugs and Cosmetics Act (1938) The Orange Book - Precise Answer ✔✔FDA's Approved Drug Products with Therapeutic Equivalence Evaluations contains approved drugs ONLY (unapproved drugs will have NDC but will not be listed) Prescription Drug advertising - Precise Answer ✔✔monitored by the FDA OTC Drug advertising - Precise Answer ✔✔monitored by the COnsumer PRoduct Safety Commission (under the e FDA AD minimum requirements - Precise Answer ✔✔- min. one approved use - generic name - brief summary, major statement, or 'adequate provision' of drug risks Sherman Antitrust act of 1890 - Precise Answer ✔✔outlawed monopolies Pure Food and Drug Act of 1906 - Precise Answer ✔✔Also known as the Wiley Act - mandated accurate labeling cGMP requirements - Precise Answer ✔✔- manufacturers must be registered with the FDA, inspected every 2 years - all drugs must come from factory registered with FDA (or considered misbranded) - if standards of strength, quality, or purity are lacking, the drug is considered adulterated Controlled Substance Act of 1970 - Precise Answer ✔✔every DEA registrant must follow all aspects of controlled substances PPPA - Precise Answer ✔✔Poison Prevention and Packaging Act of 1970 Enforced by the Consumer Product Safety Commission Requires child-resistant packaging for some substances Drug Listing Act of 1972 - Precise Answer ✔✔Amended the FDCA to require registering all drugs with the FDA-- hence NDC number (NDC 3 parts: labeler code, product code, package code) Federal Anti-Tampering Act of 1982 - Precise Answer ✔✔Federal crime to tamper with OTC products Products require tamper-resistant features on OTC medications (exempt: skin, insulin, lozenges, tooth cleaning powder-dentrifrice) Federal False Claims Act of 1982 - Precise Answer ✔✔false billing of Medicare and Medicaid whistleblowers receive 25% of recovered damages Orphan Drug Act 1983 - Precise Answer ✔✔authorized incentives to manufacturers tax credit of 50% of clinical testing costs 7 year period of exclusivity diseases < 200,000 people or for products with no reasonable expectation that the cost of research and development will be recovered by the sales revenue Hatch-Waxman Act 1984 - Precise Answer ✔✔Price Competition and Patent Act expedited and streamlined generic drug approvals streamlined patent litigation involving generic drugs generally shortened the approval process for generic drugs ANDA or 505(b)(2) -- paper NDA Prescription Drug Marketing Act of 1987 - Precise Answer ✔✔- prohibits re-importation except by the manufacturer - sale of drug samples and coupons prohibited - Patients cannot buy drugs and bring into US except if it is <90 d/s for the patient OR if an effective treatment is not available in the US, the condition is serious, and the drug being ipmortant has no unreasonable risk. - requires wholesalers to be state-licensed and meet uniform standards - placed limits on drugs that hospitals can resell-- sales to other hospitals is only permitted under shortage OBRA 1990 - Precise Answer ✔✔Omnibus Budget Reconciliation Act (OBRA)- originally mandated counseling for medicaid beneficiaries Also requires DUR program (both prospective and retrospective); Retrospective is done by the state. Prospective is done by the dispensing pharmacist. DSHEA 1994 - Precise Answer ✔✔Dietary Supplement Health and Education Act- allowed dietary supplement to be classified under food products Medical Loss Ratio Integrated Care Models Transitional Care Models Improvements to Med D MTM Biologics Price Competition and Innovation act of 2010 - Precise Answer ✔✔established an approval process for biosimilars (first biosimilar approved in 2015) part of ACA created abbreviated licensure pathway for biosimilars to become interchangeable with licensed product DQSA 2013 - Precise Answer ✔✔Drug Quality and Security Act of 2013 Resulted from the new england compounding center - amendment to FDCA - FDA now has increased authority to regulate compounding - traditional compounders vs outsourcing facilities - 503B allows facility that compounds sterile drugs for humans to be "outsourcing facilities" - outsourcing facilities do not need to go through new drug approval process, but requires * cGMP * annual 15,000 fee to FDA and pay for inspections * report ADR * provide FDA with information about products Pregnancy and Nursing Labeling Final Rule 2014 - Precise Answer ✔✔ABCDX pregnancy categories to be replaced by new categories by 2020 Drugs approved after June 30, 2001 will be required to use new labeling Drugs approved prior to 2001 will remove letter category only NYS / Federal Age For Pharmacist - Precise Answer ✔✔21 yo in NYS 18 yo federally License Renewal, NYS - Precise Answer ✔✔Every 3 years , counted from birthday month Foreign-trained pharmacist licensing - Precise Answer ✔✔Must pass FPGEE (Foreign pharmacy graduate equivalency eamination) and The Test of English as a Foreign Language (TOEFL) - needs state's intern hour requirements - Naplex - state specific exams NYS CPE Requirements - Precise Answer ✔✔45 hours every 3 years (IF <3 years, need 1.25 h per month) max 22 hrs non-live (eg 23 hours must be live) 3 hrs med errors must be ACPE-accredited no carry over first cycle not exempt NYS Intern Hours - Precise Answer ✔✔1040 (6 months) Expires 5 years from date of issue- renewable once for up to 2 years DEA Form 224 - Precise Answer ✔✔Used by individuals, hospitals, and pharmacy to apply for a DEA number Authority for noncontrols come from the state-- comes first before DEA Valid Rx Includes - Precise Answer ✔✔- PTs full name, DoB, street address - Prescriber's name, license designation, address - Name, strength, dosage form, quantity of drug oral inhalers topical drugs for oral use unit-dose if there is evidence for lack of harm Drugs that DO NOT require CR Packaging - Precise Answer ✔✔- SL nitroglycerin - SL, chewable isosorbide dinitrate <10 mg - Erythromycin ethylsuccinate granules for oral suspension , containing no more than 8 grams (tablets, < 16 g) - Cyclically administered oral contraceptives in memory aid package - Conjugated estrogens < 32 mg in mnemonic pkgs -Norethindrone < 50 mg - Medroxyprogesterone acetate tablets - Anhydrous cholestyramine in powder form - POTASSIUM SUPPLEMENTS unit dose (50 mEq max) - Sodium fluoride < 110 mg NaFl (50 mg elemental Fluoride) , or no more than 0.5% elemental fluoride - betamethasone tablets < 12.6 mg - Pancrelipase capsules - Prednisone < 105 mg -Mabendazole < 600 mg - Methylprednisolone <84 mg - Colestipol < 5 g - Sacrosidase (sucrase) preps in a solution of glycerol and water - HRT -Colesevelam < 3.75 g -Sevelamer carbonate < 2.4 g Unit Dose Labeling Requirements - Precise Answer ✔✔- Name of drug - Dose of drug (quantity of active ingredient) - BUD - Lot # - Manufacturer/Packager/Distributor - Cautionary statements USP 661 - Precise Answer ✔✔Guidance on customized patient medication packages (med paks) Can be done with consent of patient, caregiver, or prescriber Must include: Name of patient RX# (or serial number) for med pak itself, plus separate serial/Rx# for each drug in the med pak - name, strength, physical description, total quantity of drug - Direction for use and required cautionary statements - Required storage instructions - Name of prescriber for each drug - Date of preparation - BUD (MAX 60 days) - Name/address/# of pharmacy, DEA registration number if controlled substances - Each individual container shall bear a label identifying each of the drugs inside Med Paks - Precise Answer ✔✔must meet moisture permeation requirements for a class B single-unit or unit-dose container. Each container must be desigend so that it shows evidence of having been opened or is not re-sealable Med Pak Documentation - Precise Answer ✔✔- record of each med pak must contain - name and address of patient - serial number of Rx order for each of the drug - Name of manufacturer/labeler and lot number for drug - Identifying or describing design, characteristics, specifications of the patient med pak enough to prepare identical med pak - the date of preparation and BUD - Special labeling instructions - Name OR initials of pharmacist who prepared med pak Change in corporate officers/Shareholders - Precise Answer ✔✔must notify BOP within 30 days of change principal stockholder is anyone holding 10% or more of the stock Required Reporting for FIRE/FLOOD/DISASTER - Precise Answer ✔✔48 hours Required Reporting for CHANGE IN SUPERVISION - Precise Answer ✔✔7 days Required Reporting for location change - Precise Answer ✔✔30 days prior to expected relocation, inspection Renovation of registered premise - Precise Answer ✔✔must report before changes are made Change in corporate name or assumed name - Precise Answer ✔✔must report being use of new name Temporary closing - Precise Answer ✔✔- before closing, before reopening Discontinuance of registration - Precise Answer ✔✔- must be filed with BOP - arrangements must be made for drugs and records (copies of bills of sale submitted to BOP with discontinuance form)-- or face 'abandonment' - may sell FULL BOTTLES of uncontrols to another registrant - DEA must be contacted for controlls - Destroy in safe/environmentally correct manner for outdated/non- returanble drugs-- record must be kept for inspection - RECORDS MUST BE MAINTAINED FOR 5 YEARS by the owner - all drugs, devices, signs must be gone by closing date, will be inspected - Signatures will be signed and dated by corporate officer for BOP Sale of drugs at auction - Precise Answer ✔✔- notify BOP 7 days before auction date - inspector from OP will attend the auction Professional Misconduct NYS - Precise Answer ✔✔Section 6509, Article 130 Education Law (for all professions) Part 20 Rules of the Board of Regents Office of the Professions investigates and prosecutes Practicing profession without license = Class E felony Professional Assistance Program (PAP) - Precise Answer ✔✔Education Department administers the program Advised by OP's Committee for Professional Assistance Pharmacy board member sits ex officio on PAP panel Panel will interview applicants, determine if program is right for them, monitors progress, and determines whether licenssee can resume practice 6801 Article 137 - Precise Answer ✔✔administering, preparing, compounding, preserving or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions or other legal authority and collaborative drug therapy management in accordance with the provisions of section sixty-eight hundred 1-a of this article Immunizations 6801 - Precise Answer ✔✔report such administration to the patient's attending primary health care practitioner or practitioners, if any,; provide information to the patient on the importance of having a primary health care practitioner,; and report such administration, absent of any individually identifiable health information, to the DOH meningococcal tetanus diphtheria pertussis and emergency anaphylactic treatment * Certified pharmacist need a "I" on their registration * Physician or NP of the same county or adjoining county if < 75,000 ppl (patient specific order) Compounding - Precise Answer ✔✔503 B of FDCA Outsourcing facility - sterile drugs- must be registered with the Secretary of HHS label must include statement that it is a compounded drug State Board of Pharmacy - Precise Answer ✔✔Appointed by Board of Regents Assists on matters of professional licensing and professional conduct includes: >= 9 pharmacists licensed for at least 5 years Executive Secretary is appointed by the Board of Regents Requirements for Pharmacy License - Precise Answer ✔✔- application -education (bachelor's or equivalent) - Experience - Examination - 21 yo - Citizenship is not a requirement - Good moral character - FEEs: exam, re-exam, reciprocation, triennial registration Limited Permits 6806 - Precise Answer ✔✔- Pharmacy interns: enrolled in last 2 years of registered pharmacy program - graduate of a pharmacy program - experiential requirements are met - expiration date of 5 years from date of issue; renewable once for max 2 years Exempt Persons 6807 - Precise Answer ✔✔Article 137 does not affect unlicensed assistants (techs), merchants, education/experiments/research , manufacturer/wholesalers, etc. physicians/dentists/vets dispensing drugs to patients--- vials must be labeled: - name and address of dispenser - patient name and address - directions - Date - Proprietary or brand name of drug - Strength - Must comply with article 33 of PHL if controlled Prescribers cannot dispense more than 72 h/s -- except: article 28 facilities (hospitals) -- practice is > 10 miles away from a registered pharmacy -- dispensing of drugs is at no charge -- dispensing of drugs in a clinic, infirmary, or health service that is operated or affiliated with a post secondary institution -- vets -- dispensing of drugs in a medical emergency -- prescriber-compounded/reconstituted drugs, allergenic extracts, oncology/AIDs protocol Pharmacist may dispense drugs and devices to a RN pursuant to a non- patient specific regimen prescribed by a licensed MD or certified NP Pharmacy Registration and Renewal - Precise Answer ✔✔- Application, Fee, Equipment - Renewal every 3 years - Owner of pharmacy must state under oath any facts required by the state board of pharmacy - must display registration - cannot sell drugs that expire within 30 days Registration of Nonresident Establishments 6808-b - Precise Answer ✔✔- must register with the department (unless transfer is intra- company)-- renewed x3 years - must have an agent of record for service of process - must be licensed/registered in good standing with state of residence - must maintain record of drugs shipped - supply information to the department - must have toll-free number on label of each drug/device to be reachable during normal business hours 40h/week that allows patient to communicate with pharmacist with access to records - Usually state of residence will initiate disciplinary action (within 120 days from reported violation); exceptions can be made for isolated transactions Refills - Precise Answer ✔✔NYS- date must be indicated on original Rx Copies of controlled substance Rx's cannot be given to patient but can be given to practitioner Copies of non-controlled can be given to patient for informational purposes only-- must be indicated on Rx Oral authorizations must be notated on the back of Rx with name of practitioner, date, time Prescription Records - Precise Answer ✔✔- must be maintained for 5 years - include: date of filling, refilling, doctor's name, patient's name & address, RPh initials Dispense as written - Precise Answer ✔✔must be written in prescriber's own hand-- PRE-PRINTED DOES NOT COUNT if generic drug is not available, RPh can dispense Brand at generic price (substitution is not required in this case) if generic is not available and there is a medical emergency, RPh may dispense the brand at the regular price For emergency dispensing of Brand name: must record date, hour, nature of medical emergency on back of Rx Unlawful distribution of Rx blanks - Precise Answer ✔✔Class B Misdemeanor Class A misdemeanor - Precise Answer ✔✔1) refusal of admittance of board rep to pharmacy for inspection 2) refusal to deliver revoked license 3) license displayed where the pharmacist does not work/is not the owner;; or owner failing to display the license of the pharmacist employed; licensee failing to display license; use of name includes 'drugs, medicines, drugstore, apothecary, pharmacy' unless it was licensed by the department 4) agreements for compounding secret formulas 5) sale, receiving, or act of misbranded, adulterated product(s) 6) sale of products in violation of article 7) dissemination of false advertising 8) forge, counterfeit, simulate or falsely represent identification 9) selfish use of trade secret 10) tampering of labeling => misbranded 11) advertising that drug is effective when under application review Schedule A Poisons - Precise Answer ✔✔Arsenic, atropine, corrosive sublimate, potassium cyanide, chloral hydrate, hydrocyanic acid, strychnine and all other poisonous vegetable alkaloids and their salts and oil of bitter almond containing hydrocyanic acid. - requires book date of sale, name and address of purchaser, name and quantity of poison, purpose, name of dispenser Schedule B Poisons - Precise Answer ✔✔Aconite, belladonna, cantharides, colchicum, conium cotton root, digitalis, ergot, hellebore, henbane, phytolacca, strophanthus, oil of savin, oil of tansy, ceratrum viride and their pharmaceutical preparations, arsenical solutions, carbolic acid, chloroform, creosote, croton oil, white precipitate, methyl or wood alcohol, mineral acids, oxalic acid, paris green, salts of lead, salts of zinc, or any drug, chemical or preparation which is liable to be destructive to adult human life in quantities of 60 grains or less. Conditional Registration - Precise Answer ✔✔does not exceed 1 year, conditions determined by department, usually entails additional educational requirements; if initial registration period is less than 3 years, need 1.25 hrs per month of registration; more than half must be live Exempt from controlled substance regulation - Precise Answer ✔✔Naloxone, naltrexone Estratest, Estratest HS Premarin with conjugated estrogens Methyltestosterone Manufacturers and Distributors - Precise Answer ✔✔Controlled meds must be supervised by a chemist or RPh FOR PRODUCTS UNFIT FOR HUMANS OR ANIMALS: BS or BA in chemistry, pharmacology with not less than 4 years of experience in drug manufacturing, US Citizen, 21, good moral character Distributors must have class 2 license EXCEPT when: Pharmacies can be class 3a institutional dispenser limited solely for stocking in sealed emergency medication kits (by written request only)- not patient specific Class 3 B = does not authorize stock of CS (Clinics) Class 3 = hospitals, veterinary, mental, nursing homes (ONLY if Nurses, Physician, and RPh is employed) Class 2 license (distribution) with no repacking: high school diploma, US citizen, 21, good moral character, > 8 years experience Class 2a = distribution activities from out of state Class 1 license = manufacturing within NYS Class 1a license = manufacturing out of NYS Importer / Exporters - Precise Answer ✔✔Importers need clsas 9 license Import Broker = class 9a license (no physical possession of CS) Exporter = class 10 license Exporter broker = class 10 a Security - Precise Answer ✔✔Non-practitioners require minimum security standards: Schedule I and II: GSA Class 5 rated safe for < 750 pounds, bolted/cemented to floor with alarm system / VAULT Schedule III-V : Separated from all other merchandise, may be stored with other pharmaceuticals provided limited access; under constant supervision during working hours Must have alarm system on the perimeter of build, safe, or vault Research, Educational, Chemical Analysis - Precise Answer ✔✔80.36 Requires: Research of CS II-V == Requires class 4 license and DEA registration Industrial or commercial processes Schedule II-V = 4a license and DEA Instructional Activities II-V = Class 5 and DEA