PTCE Exam Questions and Answers 100% Pass

PTCE Exam Questions and Answers 100% Pass Pure Food and Drug Act - Answer- Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs Adultered drugs - Answer- Any drug that is not pure misbranded drug - Answer- Not labeled correctly FDCA (Federal Food, Drug, and Cosmetic act) - 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) - 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 - 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 - Answer- Reports to FDA side effects or adverse effects of any drugs (FAERS) FDA Adverse Event Reporting System - 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) - Answer- keeps track of all adverse effects associated with vaccines IND (Investigational New Drug) - 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 - 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 - 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 FAERS and VAERS - Answer- Reports to the CDC (centers of disease control) as well Durham-Humphrey Amendment of 1951 - Answer- • Created a distinction between "OTC" and "Legend Drugs". • Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs". • The emphasis on this act was to insure safety thru qualified medical supervision. Kefauver-Harris Amendment of 1962 - Answer- • Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval