Exam #1 Flashcards
(86 cards)
Pharmacotherapeutic
Clinical pharmacology: drugs used to treat, prevent and diagnose disease
What is pharmacology?
Study of the biological effects of chemicals
Adverse effects
Undesirable, unpleasant or even dangerous drug effects
Brand name
Name given by drug company aka trade name
Chemical name
Name reflecting chemical structure
Generic name
The original name given when the drug company that developed it applies for approval
Orphan drug
Drugs that are not profitable and are used to treat rare diseases; are not financially viable
Teratogenic
Having adverse effects on the fetus
Drug therapy: nursing responsibilities
Administer Assess effects Make regimen more tolerable Provide pt teaching Monitor pt care plan
Sources of drugs
Plants
Animal products
Inorganic compounds
Synthetic sources
Drug
Chemicals introduced into the body and affect the body’s chemical processes
FDA controls …
Scientific testing for therapeutic, toxic effects of drugs, and drug approval
FDA stages of approval
Preclinical trial Phase 1 Phase 2 Phase 3 Phase 4
Preclinical trials
Animal testing
Phase 1
Testing on young healthy adult men
Phase 2
Testing on small numbers of ppl with the disease
Phase 3
Testing in vast clinical markets
Phase 4
Drug approval and continual evaluation
Drugs will be removed from clinical trials if:
Less effective than anticipated Too toxic Unacceptable adverse effects Low benefit to risk ratio No more effective than other drugs
1938 federal food drug and cosmetic act
Mandates testing for drug toxicity and provided means of recall; established procedures for introducing new drugs
1970 controlled substance act
Defines drugs by their abuse potential; strict control over distribution, storage, and use
1983 orphan drug act
Provides incentives for development of orphan drugs for treatment of rare diseases
Pregnancy categories are:
A, B, C, D, and X
Pregnancy category A
Demonstrated no risk to fetus