Laws and Regulations Flashcards
What is HIPAA?
1966 - Health Insurance Portability & Accountability Act. Federal law that required the creation of national standards to protect sensitive patient health info from being disclosed without patient consent or knowledge.
What did the Combat Methamphetamine Act do?
2005 - restricted quantity and frequency of ephedrine, pseudoephedrine, and phenylpropanolamine
What is the Drug Listing Act?
1972 - requires drug establishments to establish and list all of their commercially marketed drug products with the FDA
What is the Food and Drug Act?
1906 - set standards for purity and strength of ingredients; outlawed interstate transport or transaction of contaminated and misbranded drugs
What is OBRA 90?
1990 - Omnibus Budget Reconciliation Act; established the DUR + patient counseling at pharmacies
What did the Durham-Humphrey Amendment do?
1951 - required all drug products to have sufficient directions for use
What is the Food, Drug, and Cosmetic Act?
1938 - set of laws passed by Congress giving the FDA the authority to oversee safety of food, drugs, medical devices, and cosmetics
What is bioequivalence and what are the laws related to it?
Generic substitution: If two drug products containing the same active chemical entity can reach the site of absorption in similar times and be absorbed to the same extent, bioequivalence can be established.
What did the Poison Prevention Packaging Act do?
1970 - The Poison Prevention Packaging Act created childproof packaging + containers
What are the Centers for Medicare and Medicaid Services?
CMS
What is the Anabolic Steroid Act?
1990 - added anabolic steroids to schedule III controlled substances; defines anabolic steroid as any drug that alters muscle growth similar to testosterone
What are some safe handling and disposal practices for hazardous drugs?
Use thick, leak-proof plastic bags, colored differently from other hospital trash bags for routine collection of discarded gloves, gowns and other related disposable material. Clearly label the plastic bags as “HAZARDOUS DRUG-RELATED WASTES.”
Keep the waste bag inside a covered waste container clearly labeled “HAZARDOUS DRUG WASTE ONLY”. Locate at least one such receptacle in every area where drugs are prepared or administered. Do not move waste from one area to another. Seal the bag when filled and tape the covered waste container.
Label needle and sharps containers in the pharmacy unit as “HAZARDOUS DRUG WASTE ONLY”.
Dispose of hazardous drug-related wastes according to federal (e.g., EPA), state and local regulations for hazardous waste. Use either an incinerator or a licensed sanitary landfill for toxic wastes, as appropriate, to dispose of this waste. Use only a licensed company to perform commercial waste disposal. While awaiting removal, hold the waste in a secure area in covered, labeled drums with plastic liners.
What is OSHA?
Occupational Safety and Health Administration - sets standards of safety in workplaces
What is the Joint Commission?
accredits and certifies healthcare organizations and programs
What is the FDA?
federal agency that regulates safety of food, drugs, medical devices, radiation emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products
