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Chapter 3

Drug regulation and Control

TermDefinition
Food and Drug Act 1906 Prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs Government preapproval of drugs is required
Harrison Tax Act 1914 established a license and a tax to the growing opiate and cocaine addiction.
Food, Drug, and Insecticide Administration 1927 Law enforcement agency formed. 1930 Renamed Food and Drug Administration (FDA)
Food, drug and Cosmetic (FDC) Act 1938 Requires new drugs be shown to be safe before marketing
Alberty Food Products v. US 1950 US Court of Appeals rules that the purpose for which a drug is to be used must be included on the label
Durham-Humphrey Amendment 1951 Defines which drugs require a Rx. Requires this legend on the label. "Caution: Fedreal Law prohibits dispensing without a prescription" or "Rx Only"
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. Signed by Lyndon B Johnson. However, Teddy Roosevelt tried getting it in 1912.
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 childproof packaging on al controlled and most prescription drugs dispensed by pharmacies. Non-childproof containers may only be used if the prescriber or patient request one.
Controlled Sustances Act (CSA) 1970 Classified in five levels according to addiction abuse. Established DEA (Drug Enforcement Administration, a division of the Justice Department.
Medical Device Amendment 1976 Requires premarket approval for safety and effectiveness of life sustaining and life supporting medical devices
Orphan Drug Act 1983 Provide incentives to promot research, approval, and marketing of drugs needed for the treatment of rare diseases.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) 1984 allows for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs
Prescription Drug Marketing At 1987 Restrict distribution of prescription drugs to legitimate commercial channels; requires drug wholesaler to be licensed by the state
Omnibus Budget Reconciliation Act (OBRA) 1990 Requires pharmacists to offer counseling to Medicaid patients regarding medications.
Anabolic Steroid Control Act 1990 Addresses the abuse of steroids by athletes, youngsters, and teenagers
Health Insurance Portability and Accountability Act. (HIPAA) 1996 Defines the scope of health information that may and may not be share among health care providers with out patient consent and provided for broad and stringent regulations to protect patients right to privacy.
Medicare Modernization Act 2003 Optional Medicare Part D to provide coverage for Rx drugs and Medication Therapy Management.
Combat Methamphetamine Epidemic Act (CMEA) 2005 Strict Controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine.
2010 Patient Protection and Affordable Care Act 2010 Health Care reform legislation. Intended to expand helath insurance access for uninsured Amercians
FDA Safety and Innovation Act 2012 User fees to enhance access to medications and medical devices and made provisions for addressing drug product shortages in the United States.
pediatric having to do with the treatment of children
Placebo an inactive substance given in place of a medication
Testing Phases 3 phases
Test Phase 1 20-100 patients; several month; mainly safe
Test Phase 2 up to several hundred patients; several months to 2 years; short-term safety but mainly effective
Test Phase 3 several hundred to several thousand patients; one to four years; safety, dosage and effectiveness
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 information that is not on the label of a drug product itself, but Is provided with the product in the form of an insert or other document
OTC ephedrine, pseudoephedrine, phenylpropanolamine CMEA Requirements have daily and monthly limits per customer; must maintain written or electronic records for two years. Record must contain: product name, quantity sold, purchaser name & address, sale date & time, proof ID, purchaser signature
Exempt narcotics medications that contain habit forming ingredients but can be sold by a pharmacist without a prescription to persons 18 or older
exempt narcotic rules Dispensing only by a pharmacist, limits of dosage in a given 48 hour period, Purchaser must be 18 years old with proper ID, a bound book with purchaser name, address; name, amount of meds purchased; date of purchase; pharmacist initials
dual marketing Classified as OTC and prescription drugs
National Drug Code (NDC) 3 sets of identification numbers assigned by the manufacturer to a drug. First set: 4-5 digits indicates the manufacturer, Second set: 3-4 digits indicates strength and dosage, Third set: always 2 digits indicates package size
controlled substance mark (CII-CV) the mark that indicates the control category of a drug with a potential for abuse
Drug Rx labels Minimum Requirements pharmacy name and address, Rx serial number, date of Rx, expiration date, name of prescriber (doctor)
CSA Schedule I high potential for abuse, no accepted medical use in US. Heroin, various opium derivatives, and hallucinogenics
CSA Schedule II high potential for abuse and dependence physically and psychologically. Have accepted medical uses. Amphetamines, opium, cocaine, methadone, various opiates. No refills
CSA Schedule III potential for abuse, lower than CI & CII. Have accepted medical uses. moderate to low physical dependence or high psychological dependence. 5 refills with in 6 month period
CSA Schedule IV lower potential for abuse than CIII. Have accepted medical uses Abuse can lead to limited physical or psychological dependence. 5 refills within 6 month period
CSA Schedule V lower potential for abuse than CIV. Have accepted medical uses. Abuse can lead to limited physical or psychological dependence. 5 refills within 6 month period
Controlled Substances five groups of drugs identified by the 1970 Controlled Substance Act (CSA) as having the potential for abuse.
DEA Form 222 This form is used to order CI &CII drugs. Each form has its own unique number. Must have triplicate copies with the number of containers and the date they were received. Must be kept on file for 2 years.
Med Watch Reporting program by the FDA that encourages healthcare professional to report adverse effects
VAERS Vaccine Adverse Event Reporting System. Maintained by the CDC and the FDA
injunction a court order preventing a specific action, such as the distribution of a potentially dangerous drug
adverse effect an unintended side effect of a medication that is negative or in some way injurious to a patient's health
recall the action taken to remove a drug from the market and have it returned to the manufacturer
Recall Classes: How many? Three
Recall Class I Where there is a strong likelihood that the product will cause serious adverse effects or death
Recall Class II Where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
Recall Class III Where a product is not likely to cause adverse effects
Recall Process Reports of adverse effects, Manufacturer agrees to recall, Customers are contacted, Recalls are listed publicly
compliance doing what is required
protocol specific guideline for pratice
liability legal responsibility for cost or damages arising form 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.
Created by: 29Ford