Grade Level: 6th, 7th, 8th
http://peer.tamu.edu/
Where this lesson can be applied:
This lesson can be used in an introductory unit on scientific processes or in a unit on body systems. This would be an appropriate lesson to use to encourage awareness and critical thinking about medications, especially during a time such as flu season.
Lesson Objectives:
Students will understand the role and importance of the FDA in dental health and in other areas of human and animal medicine. Students will learn about the FDA, the kinds of dental health products the FDA regulates, and how to read the drug facts labels on over-the-counter drugs. Students will compare and contrast prescription and over-the-counter medications. An activity requires students to apply what they have learned by interpreting over-the-counter medicine labels.
State and National Objectives:
**TAKS Tested Year** / National Science Standard:
6.2 A and E Implement comparative investigations, analyze data to formulate reasonable explanations.
6.3A and D Critical Thinking and Problem Solving and Impact of Research on Science and Society / 7.2 A and E Implement comparative investigations, analyze data to formulate reasonable explanations.
7.3A and D Critical Thinking and Problem Solving and Impact of Research on Science and Society / 8.2 A and E Implement comparative investigations, analyze data to formulate reasonable explanations.
8.3A and D Critical Thinking and Problem Solving and Impact of Research on Science and Society / A-Scientific Inquiry
C-Life Science
F- Personal and Social Perspectives
G- History and Nature of Science
Background Information for Teacher:
· The Food and Drug Administration is an agency within the U.S. Department of Health and Human Services that regulates food, drugs, medical devices, dietary supplements, blood products, biological medical products, cosmetics, radiation-emitting devices, and veterinary products in the United States.
· There are many subdivisions within the FDA including: The Center for Food Safety and Applied Nutrition (CFSAN), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), the Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC). The Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health regulates the approval of medical devices.
· In addition to knowing how the FDA operates, it is vitally important for students and the public in general, to know how to use medical devices and drugs safely. Discussing how to interpret drug fact labels will improve students’ health literacy and teach them how to use over-the-counter medicine safely and correctly.
Materials needed:
The FDA’s Role in Medicine Safety and Use PowerPoint Presentation
Find Those Facts! Worksheet
Find Those Facts! Worksheet Key
Drug Facts labels handout
Drug Facts labels worksheet
Is it a Drug? PowerPoint Quiz
Is it a Drug? Article (from FDA[1])
Tube of toothpaste with fluoride or canine toothpaste (optional)
Examples of over-the-counter drug facts labels from home (optional)
Pre-requisite to Lesson:
· It is recommended that students have a lesson in scientific method or inquiry before this lesson is taught. A PowerPoint on the scientific method/inquiry is included in this module.
Lesson Procedures: Based on 5 E Model[2] – Engage, Explore, Explain, Elaborate, Evaluate
· Engage Step Option One – Veterinarian Visit or Video Presentation on Dental Health (1 class period)
o The veterinarian visit or video presentation will excite and engage students to learn about required scientific topics.
o This lesson is designed to capitalize on students’ natural interest in animals to help motivate them to learn the required science curriculum.
o Questions are asked to involve students and help them relate this lesson to their own lives.
· Explore Step– Is it a Drug? Quiz and Discussion (30 minutes)
o This activity is a short one to encourage students to think about what items that they might commonly use are considered drugs.
o There is a PowerPoint Quiz that asks the students whether or not they think certain products are drugs. The answers may surprise some of them.
o There is an article to read afterward from the FDA that define the terms “drug” and “cosmetic” and it also addresses that some products could be both. The article briefly covers the differences in the testing of drugs versus cosmetics.
o To conclude this activity, have students write one question like those in the quiz, asking whether a product is a drug. Have the students take turns asking the rest of the class their questions. They should be able to answer these successfully after reading the article.
· Explain Step- The FDA’s Role in Medicine Safety and Use PowerPoint Presentation (1/2 to 1 class period)
o The PowerPoint presentation informs the students about the FDA’s role in medicine safety and use. The presentation identifies the divisions of the FDA. It distinguishes between over the counter drugs and prescription drugs, and show students how to read a drug label. It goes specifically into some examples using dental fillings and toothpaste.
o There are opportunities in the PowerPoint for students to answer questions and interact through discussion. There are references and notes for teachers that are located in the notes section when viewed in edit mode.
o There is a Find Those Facts! Worksheet to help the students record information from the presentation. It includes the Venn diagram from the presentation comparing prescription and over- the-counter drugs.
· Elaborate Step Option One– Medicine Label Activity (1/2 to 1 class period)
o Divide the class in groups of 3 to 5 students in preparation for the activity.
o Distribute the Drug Facts Labels and Drug Facts Label Worksheet to each group. There are three different labels available. The teacher may also bring in outside examples from home. Tubes of toothpaste that contain fluoride have a drug facts label on them, and this is a great way to relate the activity back to dental health.
o Instruct each group to interpret the drug facts label and fill out the worksheet.
o Extensions: Ask each group to share with the class something new they learned from interpreting their drug facts label or something interesting they saw on the label. Home activities for the students can be found at http://www.fda.gov/cder/medsinmyhome/ in the Teacher’s Room section.
· Elaborate Step Option Two- Other Product Research (time variable depending on depth of research)
o Have students research whether other products that they use are drugs.
o Examples might include:
§ Vitamins
§ Energy Drinks
§ Acne Products
§ Power Bars
§ Yogurt or other foods that make health claims
§ Herbs
o Ask the students how they would know that products like vitamins and energy drinks are safe if they are not considered drugs and not thoroughly researched.
· Evaluate Step-
o The drug Facts Label worksheet can be graded. Answers will vary depending on product label that is examined.
o The Find the Facts Worksheet can be also be graded with the included key.
Resources for Teacher:
· 5 E model site and other lesson plan formats: http://www.personal.psu.edu/scs15/idweb/lessonplanning.htm
· FDA Article “Is it a Drug?”
http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm
· Other product information
Vitamins and dietary supplements:
http://www.webmd.com/fda/fda-101-dietary-supplements
http://www.fda.gov/Food/DietarySupplements/default.htm
Energy Drinks:
http://www.cspinet.org/new/200612051.html
Health Fraud:
http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm137284.htm
· Medicines in My Home Activities from the FDA:
http://www.fda.gov/cder/medsinmyhome/
Portions of this lesson were adapted from Medicines in My Home, a program of the U.S. Department of Health and Human Services: http://www.fda.gov/medsinmyhome/
© Partnership for Environmental Education and Rural Health at
College of Veterinary Medicine & Biomedical Sciences, Texas A&M University
Funding support from the National Center for Research Resources, National Institutes of Health
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[1] From the website: http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm
[2] See 5E Model link under Resources at end of lesson plan