drug effects that are not the desired therapeutic effects; may be unpleasant or even dangerous.
name given to a drug by the pharmaceutical company that developed it; also called a trade name
name that reflects the chemical structure of a drug
chemicals that are introduced into the body to bring about some sort of change
food and drug administration (FDA)
federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies
drugs sold by their chemical name; not brand (or trade) name
the original designation that a drug is given when the drug company that developed it applies for the approval process
process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug
drugs that have been discovered but would not be profitable for a drug company to develop; usually drugs that would treat only a small number of people; these orphans can be adopted by drug companies to develop
over-the-counter (OTC) drugs
drugs that are available without a perscription for self treatment of a variety of complaints; deemed to be safe when used as directed
the study of the biological effects of chemicals
clinical pharmacology- the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans
initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects
phase I study
a pilot study of a potential drug done with a small number of selected, healthy human volunteers
phase II study
a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent
phase III study
use of a proposed drug on a wide scale in the clinical setting with patients who have the disease the drug is thought to treat.
phase IV study
continual evaluation of a drug after it has been released for marketing
having adverse effects on the fetus
category A drugs
adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.
category B drugs
animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women, OR animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in later trimesters.
category C drugs
animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, OR there are no animal reproduction studies and no adequate studies in humans
category D drugs
there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks
category X drugs
studies in animals or humans demonstrate fetal abnormalities or adverse reaction; reports indicate evidence of fetal risk. the risk of use in a pregnant woman clearly outweighs any possible benefit.
how became OTC..
some were approved as prescription drugs but were later found to be safe and useful for patients without the need of a perscription. *some were developed and marketed before current laws were put into effect *some were "grandfathered" into use because they've been used so long
problems to consider with OTC
taking these drugs could mask the s/s of underlying disease, making diagnosis more difficult.
taking these drugs with prescription medications could result in drug interactions and interfere with drug therapy
not taking these drugs as directed could result in serious overdoses
many pts do not consider OTC drugs to be medications and therefore do not report their use.
the controlled substances act of 1970
establishes categories for ranking the abuse potential of various drugs. the act gives control over the coding of drugs and the enforcement of these codes to the FDA and DEA (drug enforcement agency)
FDA's role with controlled substances
studies the drug and determines their abuse potential
DEA's role with controlled substances
enforcement of control. the prescription, distribution, storage, and use of these drugs are closely monitored in attempt to decrease substance abuse. each prescriber has a DEA number, which allows the DEA to monitor prescription patterns and possible abuse.
5 DEA schedules
5 divisions of controlled drugs based on their potential for abuse and physical and psychological dependence.
schedule I (c-I)
high abuse potential and no accepted medical use (heroin, marijuana, LSD)
schedule II (c-II)
high abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates.
schedule III (c-III)
less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
schedule IV (c-IV)
less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and non-narcotic analgesics)
schedule V (c-V)
LIMITED ABUSE POTENTIAL. primarily small amts of narcotics (codeine) used as antitussives or antidiarrheals. under federal law, limited quantities of certain schedule 5 drugs may be purchased without a perscription directly from a pharmacist. the purchaser must be at leat 18 years of age and must furnish suitable identification. all such transactions must be recorded by teh dispensing pharmacist.
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