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Pharmac Law
| Question | Answer |
|---|---|
| -protects public health -label requirements for OTC products -prohibits sale of "adulterated or misbranded" food and drugs | FDA - Federal Drug and Cosmetic Act |
| a drug is in the process of being made or discovered, this form must be filed with the FDA to prove efficacy and safety | NDA - New Drug Application |
| -Legend & Non-Legend (OTC) -allows verbal new prescriptions to be called in -allows refills over the phone | Durham-Humphrey Amendment |
| -Label requirements for manufacturers -regulates proper drug advertising and package inserts -requires manufacturers to be registered, inspected, and report drug reactions -requires meds in US to be safe, pure, effective | Kefauver - Harris Amendment |
| -regulated by FDA and enclosed w/ ea of the following: oral contraceptives estrogen progestin isotretinoin (Accutane) Intrauterine devices Inhalers antidepressents NCAIDS | PPI - Patient Package Inserts |
| Requires pharmacies to have the following: -phone number to poison control -reference guide for toxicities -MSDS (Material Safety Data Sheets) for any "hazardous materials" -ensures safe work environment | Occupational and Safety Act of 1970 -> OSHA |
| enacted to reduce accidental poisonings in children. Mandates child resistant containers (difficult for 80% of children under 5yrs to open and allows 90% of adults to open) -if not, requires package not child resistant" | Poison Prevention Packaging Act |
| -date of sale -name and address of purchaser -name and quantity of poison dispensed -reason for purchase -full name of dispenser | Poison Log |
| enforced and regulated by the DEA -regulates use and distributes drugs with high abuse potential to 5 schedules | CSA - Controlled Substance Act of 1970 |
| exposure to product will cause severe health problems/death | Drug Recall Class I |
| exposure to the product may cause temporary adverse health hazard | Drug Recall Class II |
| exposure to the product is not likely to cause adverse health hazards | Drug Recall Class III |
| mandated pharmacist counsel a patient with a federally funded insurance | OBRA 90 - Omnibus Reconciliation Act of 1990 |
| quality control, quality assurance, used to check and prevent errors | JCAHO - Joint Commission on Accreditation of Health Care Organizations |
| expected from the known properties of the medication. unlikely life-threatening | Type A ADR - Adverse Drug Reaction |
| infrequent and not predictable allergic reactions. May cause cancer, birth defects, serious and life threatening | Type B ADR - Adverse Drug Reaction |
| form sent to DEA upon destruction of controlled substances | DEA 41 |
| form sent to DEA after notifying police and nearest DEA office upon theft of controlled substances | DEA 106 |
| form used to register pharmacy with DEA - must be renewed every 3 years | DEA 224 |
| form used to order schedule II's brown - supplier green - DEA blue - stays in pharmacy | DEA 222 |
| Health Insurance Portability and Accountability Act of 1996 | HIPAA |
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Aliciabc
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