Lesson Plan: Understanding the Steps in a Process
Student Resource: "Center
for Drug Evaluation and Research: FAQs" [excerpt]
Media Type: FAQs
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
- 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
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.
- 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?
- 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
- Comparing and Contrasting. Explain the difference
between OTC and prescription drugs, and explain under what
circumstances these labelings are changed.
- 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?
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.