Pharmacology Foundations and Drug Names

Foundations of Pharmacology

• Pharmacology is derived from the Greek words pharmakon and logos.
• Pharmacology studies drugs, their actions, and their effects.
• Therapeutic methods include diet therapy, drug therapy, physiotherapy with water, light and heat, and psychotherapy.
• Psychotherapy identifies stressors.
• Therapeutic methods are often used in combination to treat illness.
• Biologic therapy is a new class of drugs transforming the treatment of disorders that include attacks on the body's own organs, tissues, and cells.
• Biologic agents consist of large, complex proteins manufactured in a living system.

Chemical, Generic, and Brand Drug Names

• A chemical name is most meaningful to the chemist.
• The chemist understands the exact chemical makeup of the drug.
• Generic names are important because formularies use them.
• Generic names are not capitalized.
• The official name of a drug is listed by the FDA.
• Brand or trademark names are registered by the manufacturer and are capitalized.

Drug Classifications

• Drug classifications include body system classification, such as for the cardiovascular or gastrointestinal system.
• Classifications based on therapeutic use or clinical indications include antacids and antibiotics.
• Physiologic or chemical action examples include anticholinergics and calcium channel blockers.
• Prescription drugs require an order by a health professional licensed to prescribe drugs.
• Nonprescription drugs are over-the-counter (OTC) drugs sold without a prescription.
• Illegal or recreational drugs are used for nontherapeutic purposes and are obtained illegally.
• A biosimilar product has a similar structure and function to an already approved biologic product.

Resources for Drug Information

• The official source for American drug standards is The United States Pharmacopeia (USP)/National Formulary (NF)
• USP Dictionary of USAN and International Drug Names is another official source.
• Sources for prescription and nonprescription drugs include package inserts, nursing journals, and electronic databases.
• Electronic databases include: Cumulative Index of Nursing and Allied Health (CINAHL), Lexicomp, ePocrates and DailyMed.

United States Drug Legislation

• The Federal Food, Drug, and Cosmetic Act was established in 1938, and amended in 1951 and 1962.
• The Controlled Substances Act (1970) defined five classifications or schedules (I-V) of controlled substances.
• Manufacturers, prescribers, and dispensers must register with the DEA to dispense scheduled medications and must meet requirements.
• Hospitals must keep inventory and dispersion control records for controlled substances.
• Nurses may not have controlled substances in their possession.

New Drug Development

• FDA rules and regulations divide new drug development into four stages.
• Preclinical research and development averages 18 months.
• Clinical research and development may require 2 to 10 years, averaging 5 years.
• New Drug Application (NDA) review averages 17 months.
• Postmarketing surveillance is the final stage.
• Fast tracking expedites drug development and approval for treating life-threatening illnesses.
• Parallel tracking is for patients with life-threatening illnesses who cannot participate in controlled trials when no other alternative exists.
• Black box warnings indicate a very serious life-threatening problem.
• The probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years of being released is 20%.
• The National Organization for Rare Disorders estimates that 6000 rare health conditions exist with about 20 million Americans.
• Orphan drugs are medicines developed for rare disorders.
• The Orphan Drug Act of 1983 promotes development of products that demonstrate promise for diagnosis or treatment of rare diseases or conditions.

Canadian Drug Names

• Official drug names: Any drug described specifically in the Food and Drug Regulations.
• There are some dissimilarities in brand names between Canada and the U.S.
• Chemical Names: Most meaningful to chemist.
• Proper Name: The nonproprietary or generic name used to describe an official drug in Canada.

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).

Canadian Drug Legislation

• Food and Drugs Act (1927), Food and Drug Regulations (1953, 1954, 1979) aims to protect the Canadian public through the Therapeutic Products Directorate.
• The National Association of Pharmacy Regulatory Authorities (NAPRA) assigns drugs to Schedule I, II, III, and Unscheduled.
• The Controlled Drugs and Substances Act (1997) establishes requirements for the control and sale of narcotics and substances of abuse in Canada
• Schedules I to VIII.

This lesson covers the foundations of pharmacology, including its definition and therapeutic methods. It also discusses chemical, generic, and brand names of drugs, highlighting their significance and usage.