Fundamental Concept of Pharmacology

These flashcards cover the fundamental concepts of pharmacology including drug sources, naming conventions, safety testing, human trials, and pregnancy categories.

Pharmacology

The study of chemicals-drugs-on living tissues and how those chemicals help diagnose, treat, cure, and prevent disease or correct the pathophysiology of living tissues.

Pharmakon

The Greek word for drugs.

Logos

The Greek word for science.

Digitalis

A drug made from the leaves of the foxglove plant used to treat congestive heart failure and cardiac arrhythmias by strengthening the force of heart contractions.

Premarin

A drug containing estrogen recovered from mare urine, used as hormonal therapy to manage menopausal symptoms.

Insulin

A hormonal drug used to regulate blood sugar levels in patients with diabetes mellitus; it can be recovered from humans using DNA technology.

Iron supplement

A common mineral-based drug given to patients with iron deficiency, as iron is an integral part of body proteins like hemoglobin that carries oxygen.

Synthetic drug

A manmade drug produced using chemical synthesis, which rearranges chemical derivatives to form a new compound.

Sulfonamides

A group of synthesized drugs used to treat infections like bronchitis, pneumonia, and meningitis by preventing the growth of bacteria.

Herbals

Non-woody plants classified as dietary supplements rather than drugs; they are not regulated by the Food and Drug Administration (FDA) for purity and strength.

Ginkgo

An herbal that inhibits platelet aggregation (clot formation) and can lead to increased bleeding or stroke if taken with coumadin.

Chemical Name

The name that identifies the chemical elements and compounds found in a drug, primarily used by chemists, pharmacists, and researchers.

Generic Name

The universally accepted and official proprietary name for a drug listed in official sources such as the Physicians Desk Reference (PDR).

Brand/Trade Name

A copyrighted name selected by a drug company that restricts the use of that name to that particular company.

Legend Drugs

Another name for prescription drugs, so called because their label must display the legend “Caution: Federal law prohibits dispensing without prescription.”

Therapeutic Effect

The intended physiological effect or the primary reason a drug is being administered.

Side Effect

A physiologic effect that is not the intended action, such as drowsiness occurring from an antihistamine.

Adverse Effects

Side effects that are harmful to a patient.

Acute Toxicity

The dose level determined in animal testing that is lethal or kills $50\%$ of the laboratory animals tested.

Subchronic Toxicity studies

Studies involving daily administration of a drug to at least two animal species for up to $90$ days to observe adverse effects on organs.

Chronic Toxicity studies

Animal studies that usually last the lifetime of the animal to determine long-term effects and carcinogenic potential.

Therapeutic Index

The ratio between the median lethal dose and the median effective dose, which indicates the safe dose for a therapeutic effect.

In vitro studies

Tests conducted in laboratory test tubes to determine the metabolism of a drug.

Phase I: Initial Pharmacological Evaluation

Drug trials involving a small number of healthy volunteers to determine safe dosage levels, toxicity signs, and pharmacokinetics.

Phase II: Limited Controlled Evaluation

Trials involving up to $100$ individuals with the targeted disease to monitor drug effectiveness, side effects, and optimal dose response.

Phase III: Extended Clinical Evaluation

Trials involving many physicians and large groups of participants to collect enough information to justify a New Drug Application (NDA).

New Drug Application (NDA)

An application submitted to the FDA after Phase III trials, typically occurring more than $4$ years after the drug's selection.

Phase IV Studies

Also called post-marketing follow-up, these are voluntary studies conducted by pharmaceutical companies after FDA approval to find low-level side effects.

Pregnancy Category A

Adequate and well-controlled studies indicate no risk to the fetus in the first trimester or later.

Pregnancy Category B

Animal reproduction studies indicate no risk to the fetus, but there are no well-controlled studies in pregnant women.

Pregnancy Category C

Animal studies report adverse effects on the fetus and there are no well-controlled human studies, but potential benefits may warrant use.

Pregnancy Category D

Positive human fetal risk has been reported, but potential benefits may warrant the use of the drug in selected cases despite the risks.

Pregnancy Category X

Fetal abnormalities and positive evidence of fetal risk are available; the risks clearly outweigh any potential benefits, and the drug should not be used in pregnant women.

Mechanism of Action

A description of how a drug works within the body.

Drug Order

Also called a medical prescription, it is an instruction from an authorized provider (physician, dentist, etc.) to give a patient medication.

Onset

The time period when the drug reaches the minimally effective concentration in the plasma.

Peak action

The point at which the drug reaches its maximum concentration in the plasma.

Duration

The length of time the therapeutic action of a drug will last.