Pharmacology – Chapter 1 – Introduction to Drugs

adverse effect
drug effects that are not the desired therapeutic effects; may be unpleasanr or even dangerous

brand name
name given to a drug by the pharmaceutical company that developed it; also called trade name

chemical 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

generic drugs
drugs sold by their generic name; not brand (or trade) name products.

generic name
The original chemical name of a medication (in contrast with one of its “trade names”); the name is not capitalized.

generic engineering
process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug

orphan drugs
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 drugs
OTC – Drugs that are used to treat or prevent illness and are available without a doctor’s prescription.

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

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

preclinical trials
Initial trial of a chemical thought to have therapeutic potential; uses laboratory ANIMALS, NOT HUMAN subjects

Having adverse effects on the fetus

Clinical pharmacology is the study of….
drugs used to treat, prevent, or diagnose disease.

Phase I drug studies involve….
healthy human volunteers who are often paid for their participation.

The generic name of a drug is…
the ORIGINAL name assigned to the drug at the beginning of the evaluation process.

An orphan drug is a drug that…
has been tested but is not considered to be financially viable.

The FDA pregnancy categories….
indicate a drug’s potential or actual teratogenic effects.

The storing, prescribing, and distributing of controlled substances – drugs that are more apt to be addictive – are monitored by….
the DEA

Healthy young women are not usually involved in phase I studies of drugs because….
females are more apt to suffer problems with ova, which are formed only before birth.

A patient has been taking fluoxetine (Prozac) for several years, but when picking up the prescription this month, found that the tablets looked different and became concerned. The nurse, checking with the pharmacist, found that fluoxetine had just become available in the generic form and the prescription had been filled with the generic product. The nurse should tell the patient….
that the law requires that prescriptions be filled with the generic form if available to cut down the cost of medications.

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