PTU Exam WITH VERIFIED SOLUTIONS 2023

Poison Prevention Packaging Act of 1970 • Also known as the PPPA • Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions Definition of Child-resistant packaging -cannot be opened by 80% of children younger than 5 -can be opened by 90% of adults Medications that don't require child-resistant packaging -sublingual nitroglycerin -oral contraceptives in memory-aid packaging -inhalers -inpatient meds -some OTC meds -some vitamins and supplements What is a patient package insert? -an abbreviated package insert designed specifically for patients, usually attached to the stock bottle -considered a part of the product's labeling medications that require a patient package insert -oral contraceptives -estrogen-containing medications how must patient package inserts be dispensed in regards to outpatient pharmacies? must be dispensed with every oral contraceptive/estrogen-containing medication INCLUDING REFILLS how must patient package inserts be dispensed in regards to inpatient pharmacies -must be dispensed before the first dose -must be dispensed one every 30 days afterward FDA responsible for the approval of prescription and OTC meds, drug labeling, and standards for drug manufacturing CDC -involved in national health issues -provides regulation for infection control, -immunization and vaccination requirements DEA -arrests people who break the law regarding controlled substances -sets the guidelines for dispensing/refilling controlled substances Pure Food and Drug Act (1906) -first law to regulate medications -prohibits misbranding (false labeling) -prohibits sale of contaminated products or those with unknown contents Food, Drug, and Cosmetic Act (1938) -Expanded FDA role in drug approval -set standards for drug purity, strength, and safety Durham-Humphrey Act (1951) -Created 2 classes of medications: OTC and prescription (aka legend, Rx only) -Required OTC drugs to list active/inactive ingredients, purposes/uses, warnings, dosage instructions