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ELLIST#5
KEY TERMS
| TERM | DEFINITION |
|---|---|
| cocaine | a local anesthetic found in coca leaves |
| salicylic acid | the natural drug derived from the bark of a white willow tree, and the natural forerunner to the active ingredient in aspirin |
| quinine | a drug for malaria found in cinchona bark |
| Omnibus Budget Reconciliation Act (OBRA) 1990 | US legislation which required pharmacists to provide consulting services to Medicaid patients |
| formulary | a list of drugs approved for use by patients |
| Food and Drug Administration (FDA) | the leading federal enforcement agency for regulations concerning drug products |
| Drug Enforcement Administration (DEA) | the agency which controls the distribution of drugs that may be easily abused |
| Food and Drug Act (1906) | Prohibited interstate commerce in adulterated or misbranded food, drinks and drugs. Government pre-approval of drugs is required. |
| Food, Drug and Cosmetic (FDC) Act (1938) | requires new drugs be shown to be safe before marketing |
| Durham-Humphrey Amendment (1951) | defines what drugs require prescription by a licensed practitioner and requires them to include this legend on the label: "Caution: Federal Law prohibits dispensing without a prescription" |
| Kefauver-Harris Amendment (1962) | requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug |
| Poison Prevention Packaging Act (1970) | requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies |
| Health Insurance Portability and Accountability Act (HIPAA) (1996) | Protects patient privacy |
| patent | the right to market a new drug for a specific period of time under a brand name. In effect for 17 years from the date of the drug's discovery. |
| Hatch-Waxman Act (1984) | Provides up to 5-year extension of patent protection to make up for time lost while products wen through the FDA approval process. |
| National Drug Code (NDC) number | the number assigned by the manufacturer. Each NDC number has 3 parts: 1. the manufacturer 2. the medication, strength, dosage form 3. package size |
| Class I recall | strong likelihood product has serious adverse effects/causes death |
| Class II recall | little likelihood of adverse effects; product may cause temporary/reversible adverse effects |
| Class III recall | product not likely to cause adverse effects |
| Schedule II drugs | amphetamines, opium, cocaine, methadone and various opiates |
| Schedule III drugs | anabolic steroids, various compounds containing limited quantities of narcotic substances such as codeine |
| Schedule V drugs | compounds containing limited amounts of narcotic such as codeine |
| Schedule I drugs | heroin, various opium derivatives, hallucinogenic substances |
| Schedule IV drugs | phenobarbital, sedatives (e.g. chloral hydrate), anesthetic drugs (e.g. methohexital) |
| Schedule I drugs | high potential for abuse; no accepted medical use |
| Schedule II drugs | high potential for abuse; may lead to physical or psychological dependence; current accepted medical use |
| Schedule III drugs | potential for abuse less than other schedules; current accepted medical use |
| Schedule IV drugs | low potential for abuse; current accepted medical use; abuse may lead to limited physical or psychological dependence; includes sedatives + anesthetics |
| Schedule V drugs | low potential for abuse; current accepted medical use; abuse may lead to limited physical or psychological dependence; includes compounds with limited amounts of narcotic |
| Schedule II drugs | For which schedule of drugs must the DEA # appear with the patient's full street address? |
| Schedule II drugs | For which schedule of drugs are quantities limited and no refills are allowed? |
| Schedules III, IV, V | For which schedule of drugs are prescriptions allowed to be refilled up to five times within 6 months? |
| "look-alike" regulation | law requiring that a drug and/or its container not me imitative of another drug so that the consumer will be misled |
| exempt narcotics | What are medications with habit-forming ingredients that could be dispensed by a pharmacist without a prescription? |
| cystitis | inflammation of the bladder |
| tympanitis | inflammation of the ear drum |
| mastitis | inflammation of the breast |
| fibromyalgia | chronic pain in the muscles |
| endometriosis | abnormal growth of uteral tissue within the pelvis |
| onchomycosis | fungal infection of the nails |
| anuria | inability to produce urine |
| hematoma | a collection of blood, often clotted |
| dysuria | painful urination |
| transdermal | through the skin |
| anorexia | loss of appetite |
| gastritis | inflammation of the stomach |
| neuralgia | severe pain in a nerve |
| blepharitis | inflammation of the eyelids |
Created by:
pharmtechteach
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