Ch 3 Flashcards
Food and Drug Administration FDA
Federal agency ensures drugs are safe to use and prescribed drugs will be the same
1906 Pure food and drug act
Forces manufacturers that produce drugs for sale in the US to begin following minimum standards for purity, strength and quality
1938 Federal Food, drug and cosmetic act
Requires that all new rx drugs and OTC drugs be deemed safe by the FDA before marketing drugs, cosmetics and devices to the public
1970 Controlled Substances act (CSA)
Categorizes drugs by medical uses, the potential for drug abuse and/or dependency; requires those with prescribing or distributing privileges have a DEA# to stop fraud
1983 Orphan Drug act
Gives financial incentives to manufacturers that develop drugs to treat rare diseases
Acute pain
Sudden onset of pain
Chronic pain
Prolonged pain
Drug enforcement agency (DEA)
Established to enforce provisions of the 1970 controlled supply act
Drug legend
Statement warning that any distribution without a RX is prohibited by federal law
National Formulary (NF)
Book of preparations and standards for pharmaceuticals
Omnibus budget reconciliation act (OBRA) of 1990
Legislation that mandates pharmacies to ask customers if they would like to be educated about their meds at time of purchase
Over the counter (OTC)
Any meds bought without a prescription
Schedule I
Listing of drugs not currently used in medical treatment that have a high potential for abuse
Schedule II
Listing of drugs that have usage in medical treatment but with severe restrictions because of a high potential for abuse
Schedule III
List of drugs currently used in med treatment that has less of a potential for abuse that drugs in schedules I and II
Schedule IV
Listing of drugs currently used in medical treatment but have a slight potential for abuse
Schedule V
Currently used for medical treatment with less potential for abuse than drugs in schedule IV, slight possibility for abuse and may cause limited physical or psychological dependence
US pharmacopeia (USP)
Collection of drug standards and testing that determines the strength, purity and quality of a drug
US Pharmacopeia and the National Formulary (USP-NF)
A reference compiled by combining the USP and the NF to form one source
Brand names
Proprietary drug name owned by a company
Chemical name
Drug name used to describe the anatomic or molecular structure of a substance
Drug classification
Method used to group drugs in a meaningful way
Formulary
List of medications offered in a particular hospital or health care system
Generic name
Name not owned any a particular pharm company