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 . • Required drug advertising to be more closely regulated and disclose accurate information about side effects Harrison Narcotic Act - Answer- a 1914 congressional act that criminalized the sale and use of narcotics Comprehensive Drug Abuse Prevention and Control Act of 1970 - Answer- established schedules of controlled substances and moved enforcement to the Justice Department (C-1 to C-5) Established the DEA DEA - Answer- Enforces the controlled substance act under the DOJ. Makes sure all controlled substances are manufactured, distributed, and stored properly. Control 1 (C-1) drugs - Answer- High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy, heroin, LSD) Control 2 (C-II) drugs - Answer- Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet, Norco, Fentanyl, Morphine) Control 3 (C-III) drugs - Answer- Mild pain killers, anabolic steroids and caffeine pills, can be moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine) Control 4 (C-IV) drugs - Answer- Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma, clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril) Control 5 (C-V) Drugs - Answer- Low Codeine amounts in cough suppressants. Considered the least abusive (phenergan w/Codeine, guaifenesin w/codeine) Biennial Inventory - Answer- exact count for schedule II and an estimated count for III-V drugs must be performed every 2 years C-II Supply - Answer- Only for 30 days. No partial filling or given for 90 day supply Does C-II must have a prescription hard copy? - Answer- Yes, and there are exceptions: for patients in community care or in long term IV care Expiration date for C-II? - Answer- No expiration date but just be filled in 1 month or in a 10 day period Can doctor make a phone prescription for C-II? - Answer- Only for extreme emergencies. A hard copy must be sent to the pharmacy in 7 days or pharmacy can report the doctor to DEA DEA Form 222 - Answer- must be used whenever Sch II drugs are bought, sold or transferred between pharmacies or qualified distributors, can only order 10 medications at a time Form 222 triplicate forms? - Answer- 1) Seller 2) DEA 3) Pharmacy How long must form 222 be kept in file? - Answer- For 2 years Can you make mistakes on form 222? - Answer- No, must be mistake free. If a mistake is made, it is kept on file Can you loan Form 222 to other pharmacies? - Answer- No, each for