Pharm Chapter 1 Key Terms

Pharmacology

The study of drugs and their effects on the body, including their mechanisms of action, therapeutic uses, and potential side effects.

Trade name/brand name

The name given to a drug by its manufacturer, used for marketing purposes, distinct from its generic name. Example: Advil

Generic name

The official nonproprietary name of a drug, which is not protected by trademark. It is used universally to identify the drug regardless of its brand name. Example: ibuprofen

Generic drug

Nonproprietary name

Therapeutic index

Used to compare safety of drugs

Chemically equivalent

2 or more substances that contain the same active ingredients in identical concentrations and formulations, resulting in the same chemical activity and therapeutic effects

Biologically equivalent

2 or more pharmaceutical products that have similar biological effects in terms of both efficacy and safety when administered to the same biological system

Therapuetically equivalent

2 or more drug products that are considered to be equivalent in terms of therapeutic effectiveness and safety when used in the same dose and administered in the same manner

Harrison Narcotic Act

A federal law enacted in 1914 that regulates the manufacture, importation, and distribution of narcotic drugs

Federal Drug Administration

Grants approval so that drugs can be marketed in the United States

Federal Trade Commission

Regulates the trade practices of drug companies and prohibits the false advertising of foods, nonprescription drugs, and cosmetics

Drug Enforcement Agency

Regulates the manufacturer and distribution of substances that have a potential for abuse, stimulants, and sedatives

Omnibus Budget Reconciliation Act

Mandates that pharmacists must provide patient counseling and a prospective drug utilization review for Medicaid patients

Controlled Substance Act

Sets current requirements for writing prescriptions for drugs often prescribed in dental practices

Pharmacokinetic

4 Phases of Clinical studies-with description

Phase 1: Small and then increasing doses are administered to a limited number of healthy human volunteers and determines biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug

Phase 2: Larger groups of humans are given the drug and any adverse reactions are reported to the FDA

Phase 3: Clinical evaluation involving a large number of patients who have the condition for which the drug is indicated takes place. Both safety and efficacy must be demonstrated and dosage is determined

Phase 4: Involves postmarketing surveillance. Toxicity that occurs in patients taking the drug after it is released is recorded

5 Schedules of Controlled Substances-with description

I: Highest abuse potential
II: High abuse potential
III: Moderate abuse potential
IV: Less abuse potential
V: Least abuse potential

Package inserts

Provides information regarding the chemical make up of the drug, FDA approved indications for use, contraindications, warnings, adverse reactions, drug interactions, dose and administration, and how it is supplied

Black Box Warning

Its purpose is to draw attention to the specific warning and make sure that both the prescriber and patient understand the serious safety concerns associated with that drug

Off-label uses

Any information or use outside indications

Orphan drugs

Drugs that are developed to treat rare medical conditions

Drug recall

When medications are taken off the market if there is a reasonable probability that use will result in serious adverse health consequences or death

Medicare Modernization Act

Inclusion of e-prescribing in the MMA gave momentum to its use in provider practices across the country. Expanded Medicare to include a drug benefit program (Medicare Part D)