Objectives

After completing this lesson, students will be able to:

• Explain the process by which medications are approved for use in the United States.
• Tell why some drugs are classified as prescription rather than OTC drugs, and under what circumstances these labelings are changed.
• Define side effects, and discuss medications with specific risk factors.
• Apply the reading skill of understanding the steps in a process to frequently asked questions about how medicines are approved for use.

Introducing the Lesson

Point out that many health agencies andorganizations are better known by their initials-for example, CDC (Centers for Disease Control and Prevention), USDA (United States Department of Agriculture), WHO (World Health Organization)-than they are by their full names. Write these letter combinations on the chalkboard, and challenge students to add as many others as they can, referring to their health texts if necessary. List their responses on the chalkboard, and discuss the agency or organization's full name and function.

Explain that in this lesson students will learn in detail about the workings of two of these groups. Add the letters FDA to the list on the board. Elicit that the letters stand for Food and Drug Administration, and have volunteers share what they know about this government agency (its main job is approving drugs for sale to and use by the general public).

Teaching Strategies

Ask for a show of hands among students who have taught someone else how to tie a shoelace, bow, slipknot, necktie, or the like. Note that all of the named tasks involve a process, a series of steps that occur in a fixed order. Add that arranging the steps in their proper order can be a valuable aid in teaching or learning a process.

Point out that this same strategy can be useful in improving students' understanding of reading passages that describe a process. Distribute copies of the article, or direct students to the Web site. Ask: What process does this article tell about? (The steps the FDA follows in approving drugs.)

After students have completed the reading, you may either use the following as class discussion questions or assign them as individual or group work.

Follow Up

1. Analyzing. Identify the steps that the FDA goes through to approve a drug or change a drug from prescription to OTC. What is the first step in the process? What question is asked at this initial stage?
2. Critical Thinking. Suppose that the FDA approves a drug for use, and then receives reports that some users have been hospitalized with serious, unexpected symptoms. What likely step will the agency take at this stage? Explain your answer.
3. Comparing and Contrasting. Explain the difference between OTC and prescription drugs, and explain under what circumstances these labelings are changed.
4. Synthesizing. Imagine that a pharmaceutical company seeks approval for a medication to help heart patients lead normal lives. Would this information alone be enough to allow you to predict whether the FDA would classify the drug as prescription or OTC? Why or why not?

Reading Carefully

As noted in the article, the FDA takes the view that no medication is perfectly safe. Read or review the discussion of side effects in your health text. Explain what side effects are, and give examples of these found in specific medicines.

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