Pharmacology chapter 1

Drug Definitions, Standards, and Information Sources

• Pharmacology studies drugs and their effects, derived from Greek words pharmakon and logos.
• Physiotherapy uses water, light, and heat; psychotherapy identifies stressors and methods to reduce them.
• Different therapeutic methods include diet, drug, physiotherapy, and psychotherapy, often used together.
• Biologic therapy uses a new class of drugs to treat disorders affecting the body's organs, tissues, and cells. Biologic agents are complex proteins in living systems.
• Chemical names are most meaningful to chemists, as they describe the exact chemical constitution and atom placement of the drug.
• Generic names are used by formularies, and are not capitalized.
• Official names are listed by the FDA.
• Brand or trade names are capitalized, registered by manufacturers.
• Nurses should use generic and trade names when teaching patients about new prescriptions.
• Drug classifications include body system (e.g., cardiovascular, gastrointestinal), therapeutic use (e.g., antacids, antibiotics), and physiologic/chemical action (e.g., anticholinergics, calcium channel blockers).
• Prescription drugs require a physician's order.
• Nonprescription (OTC) drugs are sold without a prescription.
• Illegal or recreational drugs are used for non-therapeutic purposes and obtained illegally.
• Biosimilars are biologic products similar in structure/function to existing approved biologics.
• Official drug standards in the US are controlled by the United States Pharmacopeia (USP)/National Formulary (NF) and the USP Dictionary of USAN and International Drug Names.
• Sources of drug information include package inserts, nursing journals, and electronic databases (e.g., CINAHL, Lexicomp, ePocrates, DailyMed).

Drug Legislation

• US Drug Legislation is governed by the Federal Food, Drug, and Cosmetic Act (1938, 1951, 1962). The Controlled Substances Act (1970) defines five classifications of controlled substances (Schedules I-V).
• The FDA monitors US drug safety.

New Drug Development

• New drug development has four stages: preclinical research and development (18 months); clinical research and development (2-10 years average); NDA review (17 months); and postmarketing surveillance.
• Fast tracking expedites drug development for life-threatening illnesses
• Parallel tracking allows for patient inclusion in trials without participation in controlled trials when no other alternatives exist.

Postmarketing Surveillance Stages

• Postmarketing drug surveillance is an ongoing review of the adverse effects of new drugs.
• A black box warning indicates a very serious, potentially life-threatening problem.
• There is a 20% probability of a drug acquiring a black box warning/being withdrawn from the market within 25 years of release.

Rare Diseases and Orphan Drugs

• The National Organization for Rare Disorders estimates 6,000 rare health conditions affect 20 million Americans.
• Orphan drugs are developed for rare disorders.
• The Orphan Drug Act (1983) promotes development of products for rare disease diagnosis/treatment.

Audience Response Questions

• 1. Nurses should use generic and trade names when teaching patients.
• 2. The best source of information is electronic databases.
• 3. The US entity responsible for monitoring drug safety is the FDA.
• 4. Schedule I drugs have the highest abuse risk.
• 5. It takes 8-15 years on average to bring a drug to market.

Canadian Drug Names and Legislation

• Official drug names are described in the Food and Drug Regulations.
• Chemical names are most meaningful to chemists.
• Proper names are non-proprietary/generic names for official Canadian drugs.
• Brand names are also used.
• Canadian Drug legislation includes the Food and Drugs Act (1927), and the Food and Drug Regulations (1953, 1954, 1979)
• The Therapeutic Products Directorate aims to protect the Canadian public.
• National Association of Pharmacy Regulatory Authorities (NAPRA) assigns drugs to categories (Schedule I, II, III, Unscheduled).
• Controlled Drugs and Substances Act (1997) regulates narcotics and controlled substances.

Sources of Drug Information in Canada

• Compendium of Pharmaceuticals and Specialties (CPS)
• Patient Self-Care: Helping Patients Make Therapeutic Choices
• Compendium of Self-Care Products (CSCP)