chapter 1 pharm

chemicals that are introduced into the body to bring about some sort of change

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

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

a pilot study of a potential drug done with a small number of selected, healthy human volunteers

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

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.

continual evaluation of a drug after it has been released for marketing

having adverse effects on the fetus

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.

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.

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

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

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.

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

• 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.

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)

studies the drug and determines their abuse potential

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 divisions of controlled drugs based on their potential for abuse and physical and psychological dependence.

high abuse potential and no accepted medical use (heroin, marijuana, LSD)

high abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates.

less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and non-narcotic analgesics)

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.