Indiana MPJE Exam Questions With Correct Answers Latest Updated 2024 (GRADED)

Indiana MPJE Exam Questions With Correct Answers Latest Updated 2024 (GRADED) Where to find federal laws and regulations - Correct answer-United States Code (USC) The Code of Federal Regulations (CFR) Majority can be found in Title 21 of both Where to find Indiana laws and regulations (Rules in Indiana) - Correct answer-The Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - Correct answer-Prevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors Food, Drug, and Cosmetic Act (FDCA) of 1938 - Correct answer-Required proof of safety of a drug Required labels to provide adequate directions for use Did not require coverage for pre-1938 drugs already on the market Durham-Humphrey Amendment of 1951 - Correct answer-Amended 1938 Act Established legend and non-legend drugs Prohibited refills of prescriptions without consent from prescriber Outlined minimal information required on the prescription label Allowed pharmacists to accept oral order from prescribers Kefauver-Harris Amendments of 1962 - Correct answer-Amended 1938 Act Required drugs to be safe and effective Established CGMPs Provided for testing in humans Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 - Correct answer-Created the DEA Created a closed system to control the manufacture, distribution, prescribing, and dispensing of all controls Poison Prevention Packaging Act of 1970 - Correct answer-Gives Consumer Product Safety Commission the authority to require special packaging of "hazardous substances"- pretty much all oral drugs Medical Device Amendments of 1976 - Correct answer-Called for all devices to be divided into classes (3), with varying amounts of control required in each one Orphan Drug Act of 1983 - Correct answer-Provided financial incentives to attract industry's interest in creating drugs for rare diseases Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984 - Correct answer-Created abbreviated new drug application for generic drugs Allowed the marketing of a generic drug without conducting clinical studies but still required CGMPs and proof of bioequivalence Prescription Drug Marketing Act (PDMA) of 1987 - Correct answer-Established procedures, requirements, and minimum standards for the distribution of prescription drugs and samples Has 6 parts: Prohibits reimportation of rx's into US unless for emergency use by the FDA Bans the actual or offer to sell, purchase, or trade a rx drug that was purchased by a hospital or facility (hospitals can sell to other entities though) Prohibits selling drug samples and selling/counterfieting coupons; requires drs to ask for drug samples in writing, prohibits pharmacies from having drug samples, establishes record keeping and regulations for samples Details how records should be kept and how to respond to record requests How to apply for a whistleblower award Requirements for wholesale distributors that all states must license The Omnibus Reconciliation Act of 1990 (OBRA 90) - Correct answer-Required that states develop stands for a reasonable effort to maintain patient profiles for all Medicaid patients and prospective DUR and an offer to counsel for all Medicaid patients Prescription Drug User Fee Act of 1992 - Correct answer-Allowed the FDA to collect fees from drug manufacturers to fund the new drug approval process Dietary Supplement Health and Education Act (DSHEA) of 1994 - Correct answerAllows manufacturers to make certain statements about dietary supplements relating to a structure or function in the body if the statement includes specific things: Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in US Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure/function Describes general well-being from consumption of a nutrient or dietary ingredient Manufacturer must have evidence that the claim is truthful and not misleading Cannot make claims about a disease or a dysfunction Health Insurance Portability and Accountability Act (HIPAA) of 1996 - Correct answerFederal standards for protecting privacy and security of patients' protected health information Food and Drug Administration Modernization Act (FDAMA) of 1997 - Correct answerAmended 1938 Act Added Rx only to labels Clarified guidelines on compounding Eliminated warning about habit forming drugs on label Drug Addict Treatment Act of 2000 (DATA 2000) - Correct answer-Allows office-based detox treatment by allowing practitioner to administer/dispense/prescribe any CIII-V narcotic approved by the FDA for detox (buprenorphine/suboxone) Prescriber can be a physician, nurse practitioner, or PA and have appropriate XDEA number Practitioners cannot treat more than 30 pts in the first year of becoming DATA waived, then can submit a notification of need and intent to treat up to 100 pts Physicians that have been approved for 100 pts can apply to treat a max of 275 Anabolic Steroids Act of 2004 - Correct answer-Placed anabolic steroids into a Schedule III substance Patient Safety and Quality Improvement Act (PSQIA) of 2005 - Correct answerEstablished a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues Food and Drug Administration Amendment Act (FDAAA) of 2007 - Correct answerAdded REMS Biologics Price Competition and Innovation Act of 2010 - Correct answer-Created an abbreviated approval pathway for biological products that are biosimilar to FDA approved biologics FDA Safety and Innovation Act of 2012 - Correct answer-Renewed FDA authorization for *accelerated approval of urgently needed drugs*; established new accelerated process, "breakthrough therapy," in addition to "priority review," "accelerated approval" and *"fast-track" procedures*. Drug Quality and Security Act (DQSA) of 2013 - Correct answer-Distinguishes between compounders who are engaged in traditional practice and those who practice outside that scope The latter can voluntarily register with FDA as an outsourcing facility and is subjected to similar FDA oversight as traditional manufacturers Comprehensive Addiction and Recovery Act (CARA) of 2016 - Correct answerImproved access to overdose treatment, allowed pharmacists can dispense naloxone, expanded prescribing of buprenorphine to NPs and PA Major Adulteration elements relevant to drugs - Correct answer-Whole or in part filthy, putrid, or decomposed Prepared, packed, or held under unsanitary conditions where it MAY have been contaminated or rendered injurious to health Methods or controls used in its manufacturing, processing, packing, or holding don't conform to current GMP Container is composed of poisonous or deleterious substance Is an unsafe coloring agent or contains an unsafe color additive Doesn't meet the official standards listed in the official compendium (USP, NF, HPUS) Strength doesn't match or quality or purity falls BELOW label claims Has been mixed to reduce its quality or strength Has been substituted wholly or in part Major Misbranding Elements Relevant to Drugs - Correct answer-Labeling is false or misleading in any way Label doesn't have the name and place of business of the manufacturer, packer, or distributor Label doesn't have accurate quantity listed Required information isn't prominently placed on the label so that an ordinary person can read and understand it The generic (established) name or active ingredients listed on the label Generic (established) name must be half the height of the brand name Adequate directions for use and adequate warnings Official labeling standards aren't met (i.e. light-resistant container, med guides, etc) Subject to deterioration and that's not not listed on the label Container is misleading Imitation of another drug Directions, when followed, are dangerous Legend drug and it's dispensed without a prescription or drug order Not packaged in special packaging when required Adulteration vs misbranding - Correct answer-Adulteration focuses more on the drug product (strength, purity, quality, manufacturing process) Misbranding focuses more on the label and labeling of a drug product Current good manufacturing practice - Correct answer-Set of regulations that establish the minimum requirements for manufacturing drug products for admin to humans or animals Manufacturers must be registered with the FDA and go through an inspection process once every 2 years Apply to manufacturers in the US or for drugs being sold in the US Criteria for pharmacy compounding - Correct answer-For an individual patient Based on the receipt of a valid prescription or drug order from a licensed practitioner Compounded by a licensed pharmacist or physician If met, products are exempt from CGMP, misbranding, and new drug requirements How much can a pharmacy compound - Correct answer-No more than 5% of the total prescriptions dispensed or distributed unless there is an understanding between the pharmacy's state and the FDA Does not including mixing or reconstituting already approved products Outsourcing facilities - Correct answer-Do not meet requirements of pharmacy compounding Have stricter requirements especially surrounding registration, labeling, and inspections Labeling requirements for an outsourcing pharmacy - Correct answer-Statement similar to this is a compounded drug Information of the outsourcing facility Batch number Expiration date Storage and handling instructions List of active and inactive ingredients Classes of medical devices - Correct answer-Class I: least potential harm to users (stethoscopes, toothbrushes) Class II: More serious than class I. Require special controls to assure the safety and effectiveness (syringes, tampons, A1c assays Class III: life-sustaining; require premarket approval (pacemakers, contact lenses) Restricted: require a rx due to potential harm (contact lenses, diaphragms) Custom devices: ordered by a healthcare provider to fit needs of a patient (orthotics, braces) Recalls - Correct answer-FDA cannot require recalls, manufacturer must voluntarily recall; the FDA does have the authority to take seizure or injunction action Class I: Most serious; reasonable probability that product will cause serious harm or death Class II: Use may cause temporary or medically reversible health consequences or the probability of serious harm is remote Class III: Least serious; not likely to cause harm Manufacturers are responsible for notifying sellers and sellers are responsible for notifying consumers Pharmacists may violate adulteration/misbranding if recalled product is sold Special packaging definition - Correct answer-Packaging designed or constructed to be significantly difficult for children under 5 to open or obtain a toxic or harmful amount within a reasonable time and not difficult for normal adults to use properly All controlled substances for oral admin must be in special packaging Special packaging testing requirements - Correct answer-At least 90% of adults should be able to open container without significant difficulty At least 85% of children under 5 should not be able to open the container in 5 minutes At least 80% of children under 5 still cannot open the package after an adult shows them how in 5 minutes