PTCE Exam Common knowledge of pharmacy| 207 QUESTIONS| WITH COMPLETE SOLUTIONS

Pure Food and Drug Act Correct Answer: Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs Correct Answer: Any drug that is not pure misbranded drug Correct Answer: Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) Correct Answer: drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics FDA (Food and Drug Administration) Correct Answer: a division of USDHHS responsible for regulating food and drug products sold to the public. Handles drug approvals, sold, and recalls of drugs 3 types of Drug Recalls Correct Answer: 1. Most severe: permanent health hazard or death 2. Medium severity: temporary or reversible damage 3. Least severe: mislabeling or misbranded drugs, low damage from drugs MedWatch Program Correct Answer: Reports to FDA side effects or adverse effects of any drugs (FAERS) FDA Adverse Event Reporting System Correct Answer: Database that contains information on adverse event and medication error reports submitted to the FDA; designed to support the FDA's post-marketing safety surveillance program. VAERS (Vaccine Adverse Event Reporting System) Correct Answer: keeps track of all adverse effects associated with vaccines IND (Investigational New Drug) Correct Answer: A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy. FDA drug approval process Correct Answer: 1. Hypothesis: comes up with the drug and reports findings (dosage, research and findings) to FDA 2. Pre-phase: consists of animal testing then human testing to small population (reports correct dosing and side effects) 3. Large Human Trial: tests on wider population with longer procedure 4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent tall man lettering Correct Answer: medication names that have mixed case lettering in the description name, which helps reduce errors between medication names that either look or sound alike