3
Drug and Supplement
Development
Learning Objectives
1 Define the term drug and distinguish between prescription drugs, over-the-counter (OTC) drugs, homeopathic drugs, and dietary supplements. (Section 3.1)
2 Discuss the different classifications of drug uses: therapeutic, prophylactic, destructive, pharmacodynamic, and diagnostic. (Section 3.2)
3 Describe germ theory and how it has affected the development of sterile compounding and key drug types, such as vaccines, antibiotics, and antivirals. (Section 3.3)
4 Explain the roles of probiotics, vitamins, in wellness. (Section 3.3)
5 Describe the discoveries that led to today’s hormone and mental health drugs and the dangerous side effects when abused. (Section 3.3)
6 Describe how poisons from World War I and World War II became used in cancer drug therapies and why it is key that technicians follow US Pharmacopeial Convention (USP) practices for hazardous drug compounding. (Section 3.3)
7 Understand the significance of genetics on new drugs for diagnosis and treatment of diseases. (Section 3.3)
8 Explain ingredient sources, the differences between active and inert drug ingredients, and why careful checking of medication histories must be done to avoid problematic allergy and medication interactions. (Section 3.4)
9 Discuss the differing processes and roles of the Food and Drug Administration (FDA) and the USP in the approval of new and investigational pharmaceutical products, generic drugs, over-the-counter drugs, homeopathic drugs, and dietary supplements. (Sections 3.5, 3.6, 3.7, 3.8)
ASHP/ACPE Accreditation Standards
To view the ASHP/ACPE Accreditation Standards addressed in this chapter, refer to Appendix B.
Past centuries saw pharmacy and medicine evolve from strictly herbal medicines to a broad range of medications and dietary supplements. We often forget how medical and pharmaceutical advances over the last one hundred years have completely transformed people’s average life span and quality of life. Most of us take for granted having drugs that help control contagious diseases, hormonal imbalances, cancer, pain, and chronic diseases, such as hypertension, asthma, and diabetes. We can also forget the dangers of medications that have not been carefully evaluated and approved, or that interact with other drugs.
Medication has the ability to transform lives by helping to control or cure illness, pain, organ failure, cancer, and contagious and chronic diseases.
Because new drug developments are built upon the scientific framework provided by earlier groundbreaking discoveries, it is important to know a little about the history of key discoveries to understand their effects on pharmacy practice today. This chapter considers these developments, the definition of drugs and other medications, and their classified uses and types of ingredients. It also explains the differences in the approval processes for prescription drugs, OTC drugs, homeopathic medications, and dietary supplements.