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Drug Reg. & Control
Chapter 3
| Question | Answer |
|---|---|
| Schedule I Drugs | Heroin, various opium derivatives, and hallucinogenic substances |
| Schedule II Drugs | Amphetamines, opium, cocaine, methadone, and various opiates |
| Schedule III Drugs | Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine |
| Schedule IV Drugs | Phenobarbital, the sedative chloral hydrate, and the anesthetic methoheixital |
| Schedule V Drugs | Compounds containing limited amounts of a narcotic such as codeine |
| Class I Recall | When there is a strong likelihood that the product will cause serious adverse effects or death |
| Class II Recall | When a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects |
| Class III Recall | When a product is not likely to cause adverse effects |
| 1951 Durham-Humphrey Amendment | Defined what drugs require a prescription |
| Kefauver-Harris Ammendment | Requires drug manufacturers to provide proof of both safety and effectiveness before marketing drugs. A need for tighter drug regulations from the thalidomide lesson led to this ammendment |
| The main purpose of phase I clinical trials is: | Safety |
| The daily sales limit of pseudoephedrine base is: | 3.6 g per purchaser |
| The NDC (national drug code) is assigned by | The manufacturer |
| In each state pharmacists are licensed by the | State board of pharmacy |
| Combat Methamphetamine Epidemic Act (CMEA) | Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine 3.6 g daily/7.5 g monthly |
| Dual Marketing | Status of medication like Plan B that are classified as both prescription (under 17) and OTC (17 & over) |
| Exempt narcotics | Medications with habit-forming ing. that can be dispensed by a pharmacist w/o a prescription to persons at least 18 yrs. of age |
| Legend drug | any drug which requires a prescription and this "legend" on the label: Rx only |
| NDC (national drug code) | The number on a manufacturer's label indicating the manufacturer and product information |
| Pharmaceutical Equivalent | Drug products that contain identical amounts of the same active ingred. in the same dosage form |
| Placebo | An inactive substance given in place of a medication during clinical trials |
| Product labeling | Important associated info. that is not on the label of a drug product itself |
| Therapeutic Equivalent | Pharmaceutical equivalents that produce the same effects in patients |
| Food and Drug Act of 1906 | Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs |
| Harrison Narcotic Act of 1914 Harrison Tax Act | Required all manufacturers, importers and physicians prescribing narcotics to be licensed and taxed |
| The Food and Drug Aministration was initially named: | Food, Drug, and Insecticide Administration |
| 1938 food, Drug, and Cosmetic Act | Required new drugs to be shown to be safe before marketing...came about because of fatal poisoning from liquid sulfanilamide |
| 1984 Hatch-Waxman Act | Allowed for quicker introduction of drugs and extension of drug patent terms |
| 1990 Omnibus Budget Reconciliation Act (OBRA) | Required pharmacists to offer counseling to Medicaid patients |
| Legend Drugs | Drugs that require prescriptions |
| Phase 2 Clinical Trial Purpose | Effectiveness mainly, but also short term safety |
| Phase 3 Clinical Trails Have How many patients | Several hundred to several thousands |
| Phase 1 Clinical Trial Purpose | Safety |
| Phase 3 Clinical Trial Purpose | Safety, Dosage, and Effectiveness |
| Pase 1 Clinical Trial Number of patients | 20-100 patients |
| Phase 2 Clinical Trial Number of patients | up to several 100 patients |
| Phase 1 Clinical Trial Time | Several months |
| Phase 2 Clinical Trial Time | Several months to 2 years |
| Phase 3 Clinical Trial Time | One to Four years |
| Pediatric Labeling Rule of 1994 mandated that: | All drugs have pediatric dosing and safety info. on their labels if the drug has potential use for pediatric patients |
| Manufacturers of generic drugs don't need to perform safety & effectiveness testing but DO NEED TO SHOW: | That a drug is both pharmaceutically and therapeutically equivalent to the corresponding proprietary drug |
| A prescription to dispense Plan B is required for who | Patients UNDER 17 |
| MedWatch | The FDA reporting system for adverse effects tht occur from use of approved drugs |
| Pharmacies located in the health care institutions (hospitals etc) are required to follow regulations of this organization | JCAHO (Joint Commission on Accredidation of Health Care Organizations) |
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