1. Driving Home the Point: Medicines, Impaired Driving, and You Ali Mohamadi, MD Medical Officer Professional Affairs and Stakeholder Engagement RADD-ONDCP Summit July 11, 2014

2. Factors that Can Impair Your Driving Emotions Age Medical Conditions Fatigue Alcohol Medicines (OTC and Prescription) Illicit or Illegal Drugs Distractions 2

3. Driving and Medicines: Proceed Cautiously Some of the ways medicines can affect your driving: Decrease attentiveness Impair judgment of time and distance Slow motor skills (reflexes) Add to effects of fatigue or lack of sleep (“drowsy driving”) and other causes of drowsiness 3

4. Prescription Medicines That May Affect Your Ability to Drive Sleeping pills Anti-anxiety medications Some antidepressants Products containing codeine (including pain relievers) Some cold remedies and allergy products Tranquilizers 4

5. When Does FDA Communicate Emerging Drug Safety Info? After an important drug safety issue has emerged after approval –Serious adverse drug reactions –Medication errors After having completed an analysis of available data –Seriousness of event, magnitude of risk, extent of patient exposure, potential for risk mitigation In some cases, before having reached a decision about whether regulatory action is warranted 5

6. How Does FDA Communicate Its Recommendations? 6

7. 7

8. 8 Drug Labeling

9. 9 Medication Guide

10. 10 Bottle Stickers: Not Regulated by FDA

11. OTC Medicines: Some Common Misconceptions OTC medicines don’t have risks I can take OTC medicine any way and in any amount I want to without harm I don’t need to read the label – I know all I need to know about the medicine My family and I have used the medicine before and we have never been harmed If some medicine is good, more is better 11

12. OTC Medicines That May Affect Your Ability to Drive Antihistamines Cold and allergy products Anti-diarrheals Anti-emetics 12

13. OTC Drug Facts Label 13

14. Drug Facts Example: Antihistamines

15. Providers and patients should partner to choose and use medicines safely by reviewing labels and medication guides Check all your medicine labels and medication guides before you hit the road  Do they say anything about drowsiness?  Do they say anything about driving or operating machinery? With your health care professional, consider if you can choose and use a different medicine or dose that is less likely to have those effects 15

16. CDER Professional Affairs and Stakeholder Engagement Email: ali.mohamadi@fda.hhs.gov 16