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ELLIST#86
KEY TERMS CH 3 - DRUG REGULATION & CONTROL
| Question | Answer |
|---|---|
| What is the Food & Drug Administration (FDA)? | a federal agency that regulates drug products |
| What is the Drug Enforcement Administration (DEA)? | the federal agency that controls the distribution of drugs that may be easily abused |
| What is the Food & Drug Act (1906)? | prohibits interstate sales of adulterated or misbranded food, drinks and drugs and requires government pre-approval of drugs |
| What is the Food, Drug & Cosmetic (FDC) Act (1938)? | requires that new drugs be proven safe before marketing |
| What is the Durham-Humphrey Amendment (1951)? | defines which drugs require a prescription by a licensed practitioner and requires this label: "Caution: Federal law prohibits dispensing without a prescription" |
| What is the Kefauver-Harris Amendment(1962)? | requires proof of safety and effectiveness before marketing a drug |
| What does the Poison Prevention Packaging Act (1970) require? | requires child-proof packaging on all controlled and most prescription drugs |
| What is the Controlled Substances Act (CSA, 1970) and what agency enforces this act? | DEA enforced law that requires classification of drugs that may be easily abused and restricts their distribution |
| What is the Omnibus Budget Reconciliation Act (OBRA, 1990)? | requires pharmacists to offer counseling to Medicaid patients |
| What is the Health Insurance Portability and Accountability Act (HIPAA, 1996)? | provides regulations to protect patients' privacy |
| What is a placebo? | an inactive substance used to test the effectiveness of drugs |
| What is a clinical test? | a test on new drugs where there is a test group and a placebo group |
| What is a blind test? | the patients in the drug trial don't know if they are in the control or treatment group |
| What is a double blind test? | neither the patient nor the doctor knows which group the patient is in |
| What is a drug patent and for how long is it in effect? | the exclusive right to market a drug for a specific period of time under the brand name that is in effect for 17 years from date of drug's discovery + 5 years extension |
| What is the Hatch-Waxman Act (1984)? | provides for up to a 5-year extension of patent protection |
| What must be on a prescription drug label? | 1. name and address of dispenser 2. prescription serial number 3. date of prescription or filling, 4. name of prescriber 5. name of patient 6. directions for use and 7. cautionary statements |
| What is a National Drug Code (NDC) number and what are the 3 parts of the label? | the number assigned by the drug manufacturer 1. manufacturer 2. medication, strength and dosage form 3. package size |
| What is a controlled substance? | a drug with potential to be abused |
| What is a controlled substance mark? | the mark (CII-CV) that indicates the control category of controlled drug |
| What is a DEA Number? | a number assigned to prescribers of controlled substances and must be on controlled drug labels |
| What are the the classes of recalls? | I. strong likelihood that the product will cause severe side effects or death, II. product may cause temporary but reversible adverse effects, III. product is not likely to cause adverse effects |
| What is MedWatch? | the FDA's Safety Information and Adverse Event Reporting Program (Form 3500) |
| What do the state boards of pharmacy do? | they license all prescribers and dispensers and administer pharmacy regulations |
| What does legal liability mean? | this means you can be prosecuted for misconduct and negligence |
| What is negligence? | the failure to do what should or must be done |
| What are Schedule I drugs? | drugs that have high potential for abuse and no accepted medical use; they may not be prescribed |
| What are Schedule II drugs? | drugs that have high potential for abuse and have an accepted medical use |
| What are Schedule III drugs? | drugs that have a lower potential for abuse and have an accepted medical use |
| What are Schedule IV drugs? | drugs that have a low potential for abuse and have a current medical use |
| What are Schedule V drugs? | drugs that have a low potential for abuse relative to Schedule IV drugs and have a current medical use |
| What is DEA Form 222? | to order C-1 and C-11 drugs |
| What is DEA Form 106? | to report theft or loss of controlled substances |
Created by:
pharmtechteach
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