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Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

Instructor Manual

Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

TABLE OF CONTENTS Purpose and Perspective of the Chapter ........................................................................... 2 Chapter Objectives ............................................................................................................... 2 Chapter Outline ..................................................................................................................... 3 Discussion Questions ........................................................................................................... 7

Part 1: Teaching Manual

Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

PURPOSE AND PERSPECTIVE OF THE CHAPTER The purpose of this chapter is to provide a comprehensive overview of key concepts and regulations in pharmacology, including drug standards, historical milestones, and the evolution of drug laws in the United States. It begins by explaining drug standards and tracing the historical development of pharmacology. This chapter outlines significant legislation, such as the Federal Food, Drug, and Cosmetic act of 1938—the first U.S. drug law for consumer safety—and the Controlled Substances Act of 1970, clarifying their provisions and impact. It explains the roles of the FDA and DEA, the meaning of USP/NF, and the classification of controlled substance schedules (C-I through C-V). Additionally, it addresses orphan drugs and emphasizes the responsibilities associated with administering medications under these laws.

CHAPTER OBJECTIVES The following objectives are addressed in this chapter: 1. Explain what is meant by drug standards. 2. Summarize the historical development of pharmacology. 3. Name the first drug law passed in the United States for consumer safety and give the year it was passed. 4. Summarize the provisions of the Federal Food, Drug, and Cosmetic Act of 1938 and its amendments. 5. Interpret what is meant by USP/NF. 6. Summarize the provisions of the Controlled Substances Act of 1970. 7. Contrast the responsibilities of the FDA and DEA. 8. Define orphan drug. 9. Differentiate between controlled substance schedules C-I through C-V. 10. State several responsibilities you have in administering medications as a direct result of the three major drug laws described in this chapter. [return to top]

Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

CHAPTER OUTLINE I. Drug History (LO 2, PPT Slides 5–8) i. From the very first documented use of “pharmacology” in ancient Egypt, where they used substances such as berries, beer, poppies, salt, and even crushed precious stones to treat ailments, it was clear that humans were determined to overcome diseases by any means necessary. II. Pharmacology Timeline (LO 2, PPT Slides 9–14) i. 16th century BCE: Earliest documented pharmacologic examples found recorded on papyri from ancient Egypt. ii. 2nd century BCE: Earliest evidence of actual “prescriptions” iii. 1st century BCE: Greek physician Dioscorides writes the De Materia Medica, which is considered the most influential work in the history of Western pharmacology. iv. 1885 a) Pasteur develops precursor to rabies vaccine. b) Oswald Schmiedeberg, known as the founder of modern pharmacology, publishes Outline of Pharmacology. v. 1897–1899: Aspirin discovered and first marketed for use. vi. 1905: German chemist Alfred Einhorn discovers procaine, giving it the trade name Novocaine (aka Novocain). vii. 1906: The Pure Food and Drug Act passed in United States. viii. 1922: Insulin first used to treat diabetes. ix. 1928: Alexander Fleming discovers penicillin. x. 1936: Chemotherapy first used to treat cancer. xi. 1937: Over 100 people die in the United States of a sulphanilamide elixir, leading to passage of the Federal Food, Drug, and Cosmetic Act in 1938. xii. 1953: Watson and Crick describe the structure of DNA. xiii. 1960: First contraceptive pill. xiv. 1958–1960 Thalidomide crisis where approximately 10,000 babies were born with deformities after thalidomide was used to treat morning sickness; this led to passage of a drug amendment act establishing the Food and Drug Administration in 1962. xv. 1969: Ibuprofen developed in Great Britain. xvi. 1991: FDA approves the first-ever treatment for hepatitis C (interferon alpha-2b). xvii. 2000: First draft of the human genome released to public; this sets the stage for genetically targeted drugs. xviii. 2017: Shingrix, the vaccine to treat shingles, approved.

Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

xix. 2020–2021: Several vaccines developed in an attempt to mitigate the COVID-19 global pandemic. xx. 2023–2024: First respiratory syncytial virus (RSV) vaccine approved. III. Drug Laws (LOs 1, 2, 4, 5, 6, 8, 9; PPT Slides 15–29) i. During the 1900s, laws were passed that specifically addressed the matter of safely dispensing drugs in the United States. ii. Drug standards are rules set to assure consumers that they get what they pay for. The law says that all preparations called by the same drug name must be of uniform strength, quality, and purity. a. 1906 Pure Food and Drug Act i. First government attempt to establish consumer protection in the manufacture of drugs and foods. ii. Required all drugs marketed in the United States to meet minimal standards of strength, purity, and quality. iii. Demanded that drug preparations containing dangerous ingredients have a labeled container indicating the ingredient. iv. Established two references of officially approved drugs: a) United States Pharmacopeia (USP) b) National Formulary (NF) b. 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951, 1962, and 1972 i. Established the Food and Drug Administration (FDA) under the Department of Health and Human Services to enforce the provisions of the Act. a) All labels must be accurate and must include a listing of all active and inactive ingredients. b) All new products must be approved by the FDA before public release. c) “Warning” labels must be present on certain preparations. d) Legend drugs must be labeled as “Caution—federal law prohibits dispensing without a prescription.” e) Certain drugs must be labeled with the legend (inscription) “Caution—federal law prohibits dispensing without a prescription.” Thus, the term legend drug refers to such preparations. The act also designated which drugs can be sold without a prescription. f) Prescription and nonprescription drugs must be shown to be effective as well as safe.

Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

g) In 1972, the National Drug Code (NDC) Directory was established. This provided the FDA with a list of all drugs manufactured for commercial distribution. 1. The first part is five numbers and identifies the manufacturer. 2. The second part is four numbers and identifies the drug. 3. The third part is two digits and identifies the package size. ii. The five schedules of controlled substances are arranged with those with the highest potential for abuse at level I and those with the lowest abuse potential at level V (Refer to Table 1-1 in the text.). c. 1970 Controlled Substances Act i. Established the Drug Enforcement Administration (DEA) as a bureau of the Department of Justice to enforce the provisions of the Act. ii. The Act: a) Isolated the abused and addicting drugs into five levels, or schedules, according to their medical value, harmfulness, and potential for abuse or addiction: C-I, C-II, C-III, C-IV, and C-V. b) Demanded security and accountability related to controlled substances; anyone (e.g., pharmacists, hospitals, physicians, and drug companies) who dispenses, receives, sells, or destroys controlled substances must keep on hand special DEA forms, indicating the exact current inventory and a twoyear inventory of every controlled substance transaction. c) Set limitations on the use of prescriptions; guidelines were established for each of the five schedules of controlled substances, regulating the number of times a drug may be prescribed in a sixmonth period as well as for which schedules prescriptions may be phoned in to the pharmacy and so on. d) Demanded that each prescriber of these substances register with the DEA and obtain a DEA registration number, to be present on their prescriptions of controlled substances; drug manufacturers must also be registered and identified with their own DEA numbers, as must pharmacists, physicians, veterinarians, and so on.

Instructor Manual: Colbert, James & Katrancha, Essentials of Pharmacology for Health Professions, 10e, 2026, 9798214116068; Chapter 1: Consumer Safety and Drug Regulations

d. Additional Drug Legislations i. The 1983 Orphan Drug Act a) Gives financial incentives to develop medications for diseases that affect a small number of people and are of low profitability. ii. Omnibus Budget Reconciliation Act (OBRA) of 1990 a) This Act mandates that all OTC drugs a patient is taking must be documented as part of the medical record. OBRA also mandates that pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient. IV. FDA and DEA (LO 7, PPT Slides 30–34) i. Responsibilities of FDA: a) Overseeing testing of all proposed new drugs before they are released into the U.S. market. b) Inspecting plants where foods, drugs, medical devices, or cosmetics are made. c) Reviewing new drug applications and petitions for food additives. d) Investigating and removing unsafe drugs from the market. e) Ensuring proper labeling of foods, cosmetics, and drugs. ii. Responsibilities of DEA: a) Concerned only with controlled substances. b) Enforces laws against drug activities, including illegal drug use, dealing, and manufacturing. c) Monitors need for changing the schedules of abused drugs. V. Health Care Professionals and the Law and Ethics (LO 10, PPT Slides 35–39) i. The following guidelines should be followed by the health care professional involved in dispensing medications: a) Keep a current drug reference source available at all times. You should be able to readily identify substances that are controlled by the DEA. b) Keep controlled substances locked securely. Double-locking is required in most situations. This means: 1. Placing the drugs in a locked safety box 2. Placing the locked box in a cupboard that is also locked.