The FDA’s Role in Medicine Safety and Use Outline of Presentation: The FDA Dental Health Products Drug Example: Toothpaste Device Example: Fillings The FDA & Drug Facts Labels Portions of this presentation were adapted from “Medicines in My Home” from the Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/medsinmyhome/ Copyright 2010. PEER.tamu.edu

Food for Thought Have you ever wondered how you can be sure the food you eat is safe? Or the medicine you take will actually work? Have you ever heard of the FDA? Where did you hear about it? Do you know what it stands for? Some people in the U.S. have traveled to other countries, like Mexico or Canada, to buy medicine because it’s less expensive, but some warn this is unsafe because medicine isn’t as strictly regulated in other countries. Explain this to students and ask them what they think it means to “regulate” medicine. The FDA regulates drugs to ensure their safety and effectiveness. This means that the FDA seeks to ensure that medicines sold in the U.S. do not cause more harm than good to the recipient (safety) and that these drugs do what they say they will do (effectiveness). Thus, there is a greater chance that loosely regulated drugs (like those from Mexico) may not be effective and may even be harmful to take. This presentation aims to help students understand that the FDA is a respected agency that performs an important service for the American public, a service that affects the student’s life in a variety of ways.

The FDA The FDA is the Food and Drug Administration The FDA is an agency within the U.S. Department of Health and Human Services. You’ve probably heard of the FDA in relation to regulating food and drugs, but the agency oversees the safety of much more than that. More information about the FDA can be found at http://www.fda.gov/opacom/hpview.html.

The FDA The FDA ensures that: foods are safe and sanitary human and veterinary drugs, biological products, and medical devices are safe and effective cosmetics are safe electronic products that emit radiation are safe. Most food safety enforcement in the U.S. is performed by the Food Safety Inspection Service, of the U.S. Department of Agriculture (see http://www.fsis.usda.gov/) Discussion Questions: -Why do you think it’s important to have an organization in charge of all this? Answers will vary, but the goal of this question for students to connect what the FDA does to everyday life. -What does it mean that the FDA ensures safety and effectiveness? Answer: safety: that it doesn’t do more harm than good; effectiveness: that the product actually accomplishes what it says it will (e.g. that pain medication actually alleviates pain.)

This and more information is found in FDA & You Issue 9. The FDA’s Centers The FDA divisions include: The Center for Food Safety and Applied Nutrition The Center for Drug Evaluation and Research The Center for Biologics Evaluation and Research The Center for Devices and Radiological Health The Center for Veterinary Medicine The Center for Tobacco Products The Center for Toxicological Research Additional information about each center to share with students if time allows. This will help students understand exactly what each division does: 1. The Center for Food Safety and Applied Nutrition (CFSAN): Regulates food and cosmetics to ensure they are safe, wholesome, sanitary, and properly labeled. 2. The Center for Drug Evaluation and Research (CDER): Regulates over-the-counter and prescription drugs to ensure they are safe and effective. 3. The Center for Biologics Evaluation and Research (CBER): Have you ever donated blood or gotten a flu vaccine? Then you’ve been around products regulated by CBER. These products are called “biologics.” Biologics are products made from living sources (humans, animals) or microorganisms (viruses, bacteria). Some examples are vaccines, allergy shots, lab tests, blood donations, and human tissue transplants. 4. The Center for Devices and Radiological Health (CDRH): Regulates medical devices to ensure they are safe and effective. Have you ever used contact lenses or a toothbrush? Then you have used something that CDRH regulates. Medical devices include things like LASIK surgery lasers, pacemakers, ultrasound machines, wheelchairs, and even tongue depressors. Can you think of some more examples? 5. The Center for Veterinary Medicine (CVM): Regulates food additives and drugs that are given to animals (both pets and animals used as a human food source). The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. 7. The National Center for Toxicological Research (NCTR), FDA's internationally recognized research center, plays a critical role in the FDA’s mission.  NCTR—in partnership with researchers from elsewhere in FDA provides innovative technology, methods development, vital scientific training, and technical expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles. This and more information is found in FDA & You Issue 9.

Dental Products The products the FDA regulates includes dental health products. Which FDA divisions do you think regulate dental health products? Let’s take a closer look at two examples of dental products: dental fillings and toothpaste. Answer: The Center for Devices and Radiological Health (CDRH) regulates medical devices, which includes dental health products. The Center for Drug Evaluation and Research regulates drugs, which includes toothpaste with fluoride.

Dental Fillings Have you ever gone to the dentist to get a cavity fixed? If you have, then you’ve gotten a filling. To treat the cavity, your dentist first removed the decayed part of the tooth and then rebuilt (“filled”) your tooth with a filling material. Picture from: http://www.topnews.in/health/files/Dental-Amalgam.jpg

Dental Fillings How They Work There are two common kinds of filling material: amalgam and composite. Amalgam fillings are made of different metals and are silver in color. Composite fillings are white and are composed of different organic polymers and inorganic materials, such as quartz. Amalgam contains mercury, and some critics claim that it can leach out of the filling and build up toxic levels in the blood. This is highly controversial. You might want to assign a Web quest for students to explore this issue.

Dental Fillings Why they’re needed Dental fillings stop the development of dental cavities and prevent more serious infections from occurring. Pictures from ADA: http://www.ada.org/public/topics/fillings.asp Composite Filling Amalgam Filling

Toothpaste How It Works Toothpaste helps prevent tooth decay, but how? Abrasives scrape away plaque and remove food stains. Fluoride helps prevent future tooth decay. Believe it or not, fluoride toothpaste is considered a drug by the FDA because it contains fluoride! It also contains other chemicals that might be hazardous if swallowed (always rinse well after brushing teeth). Explanation: Toothpaste contains abrasives which scrape away plaque and remove food stains. Toothpaste contains fluoride, which helps prevent future tooth decay by actually strengthening the enamel of your teeth. Some toothpastes also contain ingredients that chemically prevent the growth of bacteria on your teeth (ingredients like Xylitol and Triclosan). Note: Toothpastes that do not contain fluoride are NOT considered medical drugs.

Toothpaste Why It’s Needed Toothpaste and regular tooth brushing are essential in preventing tooth decay. Pictures from http://www.virginmedia.com/images/04toothpaste400x300.jpg

Beyond Brushing Brushing cannot always get into all the cracks between teeth. That is why dentists recommend flossing and water picks. Pictures from: http://theblvdmag.com/wp-content/uploads/2009/11/man-flossing-getty.jpg http://www.heart-valve-surgery.com/Images/water-pik-heart.jpg

Think about it: How has the FDA affected your life today? Think about all of the products you have used today! From toothpaste, to aspirin, to your dental fillings, the FDA has had an impact on your life today.

Prescription vs. Over-the-Counter Drugs How are they different? How are they the same?

Prescription vs. Over-the-Counter (OTC) Both types Directions must be followed carefully Children use only with permission of a parent or guardian A pharmacist can answer questions Prescription Ordered by a doctor Bought at a pharmacy Ordered for one person to use only (no sharing) Over-the-Counter Don’t need doctor’s order Bought off the shelf May be used by more than one person

How to Know? So how do you know which OTC medicine to take when you feel ill? Look at the Drug Facts Label! Let’s take a closer look… OTC stands for Over-the-Counter. All OTC drugs have a Drug Facts Label. While the information is a little different for each medicine, the design of the Drug Facts Label and the order of the different sections is always the same. This makes it easy to compare different medicines when you are trying to choose the right medicine for your problem. It also makes it easy to find the information you need to use your medicine correctly and safely.

Antique medicine bottle with Drugs Facts Label There are 6 sections on the Label: Active Ingredients / Uses Warnings Directions Other information Inactive Ingredients Questions Antique medicine bottle with no Drug Facts Label! Was it safe? Picture from: http://antiquemedicines.com/forum/viewtopic.php?f=35&t=97&start=10

Active Ingredients & Uses

Active Ingredients Active Ingredients are the parts of a medicine that make it work. What does the label tell us about the Active Ingredients? Name of ingredient Amount of ingredient in each dose Purpose of ingredient (What it does) Uses of the ingredient (The problems it treats)

Warnings

Warnings The Warnings Section tell you: When you should not use the medicine at all When you should talk to your doctor first How the medicine might make you feel When you should stop using the medicine Things you should not do while taking the medicine.

Warnings: Allergy Alert! The Allergy Alert gives the symptoms of an allergic reaction to this medicine. When your body has an allergic reaction, you may have Itching Swelling Rash Fainting Hives Trouble breathing Additional Notes: If you think you are allergic to a medicine, do not use it. If you think that you or someone else is having an allergic reaction, -Tell an adult right away. -Call 911 for trouble breathing or fainting.

Warnings: Other Sections “Do Not Use” Tells you when you shouldn’t take the medicine. “Ask a Doctor/Pharmacist…” Tells you when you need to consult a Doctor or Pharmacist before using the medicine. “When Using This Product” Special information about taking the medicine. Examples of “When Using This Product” Section: -do not take more than directed -take with food or milk if upset stomach occurs -drowsiness may occur -avoid contact with eyes

Warnings: Other Sections “Stop Use and Ask a Doctor If...” Tells you reasons to stop taking the medication. “Keep Out of Reach of Children” Young children may think medicines taste really good, but medicine can harm them if they take too much! Example Reasons to “Stop Use…” -If you have an allergic reaction -If you have new problems like stomach pain, throwing up, or dizziness -If you are not feeling better after a certain number of days Keep Out of Reach additional notes: If someone you know takes too much medicine or the wrong medicine, tell an adult right away. They can call the Poison Control Center for help.

Directions

Directions The Directions tell you How much medicine to use How often to use it How long you can use it Pictures from: http://img.webmd.com/dtmcms/live/webmd/consumer_assets/site_images/articles/health_tools/otc_kids_safety_slideshow/webmd_photo_of_medicine_measuring_spoon.jpg http://www.wellpromo.com/search/t/textured-architectural-glass/index.htm

Other Info, Inactive Ingredients, Questions

All the Rest “Other Information” How to store your medicine when you’re not using it “Inactive Ingredients” are used to: Form a pill Add flavor or color Make a pill dissolve quickly in your mouth Help medicine last longer on the shelf The “Questions” section tells you where to go to ask questions about the medicine or report an unexpected reaction. Flavor picture from: http://www.marksdrug.com/pictures/flavor_logo2.gif

It’s Your Turn… Now you’ll get to interpret a Drug Facts Label on your own!