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Intro to Pharm Tech
Ch. 3 - Drug Regulation & Control
| Term | Definition |
|---|---|
| MedWatch | a reporting program that encourages health care professionals to report theft |
| generic drug | after the patent is expired, other companies can copy the drug, but it must have the same active ingredients as the brand drug. |
| Rx serial # or transaction # | must include in a dispensed drug label |
| legend drug | any drug that requires a Rx and labelled "Rx only" |
| pediatric | treatment for children |
| placebo | an inactive substance given in place of a medication |
| pharmaceutical equivalent | drug products that contain identical amounts of the same active ingredients in the same dosage form. |
| therapeutic equivalent | pharmaceutical equivalents that produce the same effects in patients |
| product labeling | important associated info that is not on the label, but in the insert, brochure or other document. |
| Combat Methamphetamine Epidemic Act (CMEA) | federal law that sets daily and monthly limits on OTC sale of pseudo-ephedrine and ephedrine (3.6g/day or 7.5g/mon Sudafed, Claritin, and Alavert-D). |
| dual marketing | status of medications like Plan B that are classified as both Rx and OTC drugs. |
| exempt narcotics | medications w/ habit forming ingredients that could be dispensed by a pharmacist w/out Rx to persons at least 18 years of age. |
| controlled substance mark | the mark (CII - CV) that indicates the control category of a drug w/ a potential for abuse. |
| controlled substances | 5 groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled. |
| controlled substance schedules I (C-I) | high potential for abuse, no accepted medical use. Ectasy, heroin, hallucinogenic substances. |
| controlled substance schedules I (C-II) | high potential for abuse. Amphetamines, opium, cocaine, methadone, opiates |
| controlled substance schedules I (C-III) | potential for abuse is less than C-I and C-II. Steroids, codeine |
| controlled substance schedules I (C-IV) | low potential for abuse. Phenobarbital, the sedative chloral hydrate and the anesthetic methohexital. |
| controlled substance schedules I (C-V) | low potential for abuse |
| adverse effect | an unintended side effect of a medication that is negative or in some way injurious to a patient's health. |
| injunction | a court order preventing a specific action, such as the distribution of a potentially drug |
| recall | the action taken to remove a drug from the market and have it returned to the manufacturer. |
| recall classifications | there are 3 classes I, II and III. |
| Recall Class I | serious can lead to death |
| Recall Class II | less serious, may cause temporary but reversible adverse effects |
| Recall Class III | not likely to cause adverse effect |
| the recall process | 1. report of adverse effects, 2. manufacturer agrees to recall, 3. customers contacted 4. recall listed publicly |
| compliance | doing what is required |
| protocol | specific guideline for practice |
| liability | legal responsibility for costs or damages arising from misconduct or negligence. |
| negligence | failing to do something that should or must be done. |
| ethics | a branch of philosophy that helps determine what should be done in a principled sense. |
| Food and Drug Act, 1906 | prohi ybits misbranded food, drinks and drugs. Government preapproval of drugs is required. |
| Harrison Tax Act, 1914 | establishes that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax. |
| Food, Drug and Insectide Administration, 1927 | former named of the FDA which has been renamed in 1930. |
| Food, Drug and Cosmetic (FDC) Act, 1938 | requires new drugs be shown to be safe before marketing in the response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction. |
| Alberty Food Products v. U.S., 1950 | the U.S. Court of Appeals rules that the prupose for which a drug is to be used must be included on the label. |
| Druham-Humphrey Amendment, 1951 | defines which drugs required Rx by a licensed practioner and had to include "Rx only" legend. |
| Kefauver-Harris Amendment, 1962 | requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug. |
| Social Security Act, 1965 | establishes the Medicare program. |
| Fair Packaging and Labeling Act, 1966 | requires all consumer products in interstate commerce to be honestly and informatively labeled. |
| Poison Prevention Packaging Act, 1970 | requires child proof packaging on most Rx drug. |
| Controlled Substance Act, 1970 | classifies 5 levels of controlled substance that have potential for abuse and therefore restricts their distribution; establishes the Drug Enforcement Administration (DEA) as a division of the Justice Dept. |
| Medical Device Amendment, 1976 | requires premarket approval for safety and effectiveness of life-sustaining and life-supporting medical devices. |
| Orphan Drug Act, 1983 | provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare disease. |
| Drug Price Competition & Patent Term Restoration Act, 1984 (Hatch-Waxman) | allows for bothe the extension of drug patent terms and quicker introduction of lower-cost generic drugs. |
| Rx Drug Marketing Act, 1987 | restricts the distribution of Rx drugs to legitimate channels & requires wholesale licensing. |
| Omnibus Budget Reconciliation Act (OBRA), 1990 | requires pharmacists to offer counseling to Medicaid/ MediCal patients regarding medications |
| Anabolic Steroid Control Act, 1990 | address the abuse of steroids by athletes, and especially youngster and teenager. |
| Health Insurance Portability and Accountability Act (HIPAA), 1996 | provides standards for the use and disclosure of individual's health info and individual's privacy rights. |
| Medicare Modernization Act, 2003 | establishes optional Medicare Part D to provide coverage for Rx drugs and Medication Therapy Management (MTM). |
| Combat Methamphetamine Epidemic Act, 2005 | establishes strict controls on OTC sales of pseudoepherine, ephedrine, and phenylpropanolamine. |
| Patient Protection and Affordable Care Act, 2010 | health-care reform legislation of the 111 U.S. Congress intended to expand health insurance access for uninsure Americans. |
| FDA Safety & Innovation Act, 2012 | establishes user fees to enhance access to medications and medical devices and made provisions for addressing drug product shortage in U.S. |
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