Lecture 1 (Chapter 1) Flashcards
When a particular drug is being investigated by a company, it is identified by its _______ name.
Chemical; it is determined by its chemical structure.
If the chemical structure is unknown at the time of investigation, a ______ name is assigned. It can be a combination of letters and numbers.
Code
Each drug has only one _____ name, but can have many _____ names.
Generic; trade
“pharmaco-“ means?
“drug” or “medicine”
The ______ name is capitalized.
trade
Trade names are protected under the ______ _____ law for _____ years.
Federal Patent; 20
The brand name is technically the name of the company. It can be used interchangeably with ____ name.
trade
The FDA requires that generic drugs (if they are to be used instead of brand names) have the same ______ ________ as the brand name drugs and….?
active ingredients; enter the bloodstream at the same rate
When two formulations of a drug meet the chemical and physical standards established by the regulatory agencies, they are termed ________ equivalent.
chemically
When two formulations of a drug produce similar concentrations of the drug in the blood and tissues, they are termed _______ equivalent.
biologically
Before generic drugs are marketed, they must be shown to be _______ equivalent.
biologically
If the generic drugs are shown to have equal therapeutic effects as the the brand name, they are deemed _______ equivalent
therapeutically.
In 1914, this established regulations concerning the use of opium, opiates, and cocaine.
Harrison Narcotic Act
The FDA is part of….(2)
The Department of Health; Human Services
The _____ determines what drugs may be sold by Rx and OTC (in the U.S.) It regulates the labeling and advertising of Rx drugs.
Food and Drug Administration (FDA)
The ________ regulates the trade practices of drug companies and prohibits the false advertising of foods, OTC drugs, and cosmetics.
Federal Trade Commission (FTC)
The ________ of the Department of Justice, administers the Controlled Substances Act of 1970. It regulates the manufacture and distribution of substances that have potential for abuse.
Drug Enforcement Administration (DEA)
The newest regulation concerning drugs is the _______. Beginning in 1993, pharmacists must provide patient counseling and prospective drug utilization review for Medicaid patients.
Omnibus Budget Reconciliation Act (OBRA)
The Drug Amendments of 1962 caused major change. _______ to the use of drugs must be made available to the patient.
contraindications
“Orphan” status drugs are used only if the diseases occur in _________ in the United States.
less than 200,000
The clinical studies of drugs involve 4 phases. Phase 1 has a _____ sample group of healthy human volunteers, and primarily determines ______.
small; safety.
The clinical studies of drugs involve 4 phases. Phase 2 has ______ groups of people and primarily determines ________ of the drug.
larger; effectiveness
The clinical studies of drugs involve 4 phases Phase 3 has large groups of people who have the condition for which the drug is indicated. ________, ________, and ________ is determined in this stage.
Safety, efficacy, and dosage
The clinical studies of drugs involve 4 phases. Phase 4 involves ___________.
postmarketing surveillance
