After reading this chapter, the student should be able to:
- Explain the interdisciplinary nature of pharmacology and give examples of subject area expertise needed to learn the discipline well.
- Identify groups of occupations in which a knowledge of pharmacology is important.
- Explain how the disciplines of therapeutics and pharmacology are interconnected.
- Distinguish between therapeutic drugs and agents such as foods, household products, and cosmetics.
- Compare and contrast traditional drugs, biologics, and natural alternative therapies.
- Identify the advantages and disadvantages of prescription and OTC drugs.
- Distinguish between pharmaceutics and pharmacology.
- Discuss the history of U.S. standards, acts, and organizations leading to the requirement that drug safety must be proven before marketing.
- Discuss the role of the U.S. Food and Drug Administration in determining whether drugs may be used for therapy.
- Discuss the roles and responsibilities of branches within the FDA in overseeing traditional therapeutic drugs, biologics, and natural alternative therapies.
- Identify four stages of approval for therapeutic and biologic drugs.
- Discuss current challenges facing the FDA in approving new drugs for market.
- Explain the role of Health Canada in the management of Canadian health, drug, and safety issues.
- Describe the Canadian drug approval process and explain points of similarity to the U.S. approval process.
- Discuss the challenges facing healthcare professionals in view of modern-day bioterroist threats.
