chapter 14 (prescription, otc drugs, & natural health products) Flashcards
prescription drugs
medicinal drugs available to the public only when approved by a medical professional and dispensed by a licensed pharmacist.
over-the-counter (OTC) drugs
medicinal drugs available to the public without the requirement of a prescription. aka nonprescription drugs.
natural health products
vitamin or mineral supplements, or herbal products, often marketed to have some sort of health benefit.
dietary supplements
products (other than tobacco) distributed with the intention of supplementing the diet, that contain a vitamin, mineral, amino acid, herb or other botanical product, enzyme, organ tissue, metabolites, or any combination of these substances.
research ethics board
institutional committee that reviews all requests for clinical trials. it analyzes each proposal for ethical issues, appropriate informed consent documents, conflicts of interest, and financial agreements.
phase 1 trials
first stage of clinical testing, in which an experimental drug is administered to healthy volunteers to check for possible side effects and determine patterns of absorption and elimination. often most risky phase because it is being administered to humans for the first time. ~10-100 healthy volunteers.
phase 2 trials
second stage of clinical testing, in which an experimental drug is given to a small population of patients who have the medical condition for which the drug is considered a possible treatment. ~100-500 people. double-blind.
phase 3 trials
third stage of clinical testing, in which an experimental drug is given to a large population of patients, through which issues of safety, effectiveness, and proper dosage levels are finalized. ~1000-3000 people. long and expensive.
phase 4 trials
fourth phase of clinical testing, in which possible adverse reactions to a drug that is already available to the public are monitored by physicians who have prescribed it.
bioequivalence
characteristic of two drugs in which all pharmacological, physiological, and therapeutic effects are identical.
bioavailability
characteristic of two drugs in which they have an identical rate of entering the bloodstream and reaching the site of action.
pharmaceutical equivalent
drug that is identical in therapeutically active ingredients, salt or ester form, route of administration, dosage, and strength. ex. generic form of drug.
pharmaceutical alternative
drug that has same active ingredients but differs in salt or ester form, route of administration, dosage, and/or strength.
nonsteroidal anti-inflammatory drug (NSAID)
any of a group of otc analgesics (aspirin, ibuprofen, naproxen) or prescription analgesics (celebrex) that are unlike cortisone-based drugs but nonetheless reduce pain and swelling caused by injury or disease.
salicylic acid
drug developed in the nineteenth century to treat mild to moderate pain; it is extremely irritating to the stomach.
