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Intro to Pharm Tech

Ch. 3 - Drug Regulation & Control

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.
Created by: Hip



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