Prescription and Over-the-Counter Medications

1. Presented for: 3rd Annual FTA Drug and Alcohol National Conference April 30 – May 1, 2008 Presented By: Robbie Sarles Prescription and Over-the-Counter Medications

2. FTA RX/otc Initiative Background • 2000 – National Transit Safety Board (NTSB) issued a directive to the Federal Transit Administration (FTA) • Educate transit systems on potential safety risks associated with the use of prescription and over-the-counter medication use by employees who perform safety-sensitive duties • Create reporting mechanism • Incorporate medical review • Train employees

3. FTA RX/otc Initiative Background • 2000 – FTA issued a “Dear Colleague” letter to all grant recipients • Establish prescription and over-the-counter drug policy • Institute educational programs that address the potential dangers of prescription and over-the-counter drug use

4. FTA RX/otc Initiative Background • 2001 – NTSB called for nationwide changes in how transit agencies monitor employees’ medical and drug-related problems • Increased pressure following MTA accidents

5. FTA RX/otc Initiative Background • 2002 – FTA responds • Dedicated page of newsletter to prescription and over-the-counter medication use awareness • Incorporated discussion in FTA-sponsored/supported workshops and conferences • Conducted survey of transit agencies on prescription and over-the-counter policies and procedures • Created toolkit of sample policies, procedures, and training materials • Investigated procedures used by other modes

6. FTA RX/otc Initiative Background • 2003 – New York City ferry boat accident • Pilot of ferry was under the influence of prescription painkillers (Tramadol) and diphenhydramine as found in over-the-counter allergy remedies • Known side effects include drowsiness, dizziness, and confusion • NTSB determines probable cause of accident was pilot’s “unexplained” incapacitation and failure of New York City DOT to implement and oversee safe, effective operating procedures

7. FTA RX/otc Initiative Background • 2006 – Prescription and over-the-counter medications listed in top ten contributing factors in truck accidents • Large truck crash causation study assessed 1,000 factors • Prescription medications ranked third of the most commonly-cited factors in major truck crashes (cited in 26.3% of major crashes) • Over-the-counter medications ranked eighth, cited in 17.3% of major truck crashes • Prescription medication was the number one cause in driver-related factors • Over-the-counter medication ranked fourth among driver-related factors • Illegal drug use and alcohol use did not make the top twenty

8. Where are we?

9. FTA Guidance • Published employer prescription and over-the-counter medication policy guidelines

10. FTA Guidance - FTA Recommended Policy Elements • Purpose of Policy • Acknowledges risks associated with Rx/OTC use • Emphasizes safety • Balances the treatment of medical conditions and the requirements of performing safety-sensitive job duties • Not intended to force employees in need of medical attention to work or keep employees who are eligible to work off duty for receiving treatment of a medical condition

11. FTA Guidance - Suggested Elements of an Rx/OTC Policy • Define processes and procedures that implement the policy, such as: • Medical review/authorization • Reporting • Use of leave benefits; limitations

12. FTA Guidance - Suggested Elements of an Rx/OTC Policy • Define Consequences of Violating Specific Policy Provisions • Use of Rx/OTC that contribute to cause or increase the severity of an accident • Failure to report use • Failure to obtain medical authorization • Other policy provision violations

13. FTA Guidance - Suggested Elements of an Rx/OTC Policy • Ensure that the policy emphasizes and maintains confidentiality • Records • Interaction with medical practitioner

14. FTA Guidance - Suggested Elements of an Rx/OTC Policy • Defined Roles and Responsibilities • Employees • Management/Supervisors • Medical Practitioner (Physician, Dentist, Physician’s Assistant, Optometrist, Chiropractor, Other) • Pharmacist • Employer MRO/Physician

15. FTA Guidance • Provided guidance and understanding on reading and understanding over-the-counter medication labels • Published safety-sensitive employee guidelines for use of prescription and over-the-counter medication

16. FTA Guidance – Safety sensitive employee guidelines for use of RX/OTC • Be cautious – all Rx/OTC have the potential to be dangerous • Inform your medical practitioner • Sensitive duties performed • Other Rx/OTC/dietary supplements taken • Provide complete medical history • Solicit information from your pharmacy • Read warning labels • Do not over-medicate • Cite the strength/dosage of the prescription

17. FTA Guidance – Safety sensitive employee guidelines for use of RX/OTC • Never take anyone else’s medication • Always monitor your reaction • Avoid Rx/OTC that have caused problems in the past • Ask for alternative treatments or dosage schedule DO NOT perform safety-sensitive duties while impaired!

18. FTA Guidance • Provided guidance on documenting prescription and over-the-counter medication involvement in accidents • Guidance on developing an effective employee awareness training program

19. FTA Guidance - Suggested Employee Awareness Training • Introduction • Purpose of Rx/OTC policy • Balance treatment of medical condition with safe performance of job duties • Applicability – Safety-sensitive employees or all employees • Employee responsibility for treatment and safe performance of duties

20. FTA Guidance - Suggested Employee Awareness Training • Training Elements • An overview of your system’s Rx/OTC policy • An overview of your system’s procedures • Medical authorization • Notification/reporting • Forms if applicable • Consequences of policy violations • Leave policy • Sick leave/paid time off • Limitations on use

21. FTA Guidance - Suggested Employee Awareness Training • Training Elements • Risks associated with Rx/OTC use • Definition of Rx and OTC • How to read a label • How to read Rx information sheets • Side effects of concern • Common sense rules for taking medication

22. FTA Guidance • Published sources of training materials

23. FTA GUIDANCE – Sources of Training Materials • US Food and Drug Administration • www.fda.gov • Consumer Healthcare Products Association • www.chpa-info.org • Center for Drug Evaluation and Research • www.fda.gov/cder • National Council on Patient Information and Education • www.bemedwise.org • Agency for Healthcare Research and Quality • www.ahrq.gov

24. FTA Guidance • Provided list of steps to evaluate the risks and benefits of a prescription medication • Model transit Rx/OTC approach

25. FTA Guidance - Medical Review Procedure • Medical Authorization • Employee obtains medical authorization form from employer • Employee asks about side effects and potential impact on ability to perform duties • If no adverse impacts – Medical practitioner signs release indicating employee may perform duty • If adverse impacts – Medical practitioner signs indicating employee must be off of duty for a specified amount of time • Employer may or may not keep form for documentation

26. FTA Guidance - Medical Review Procedure • Medical Authorization (cont’d) • Form may be reviewed by the employer’s Physician/MRO • After discussing with prescribing physician, may overturn authorization.

27. FTA Guidance • Published alerts • Antihistamines • Dietary supplements • Ritalin • Combining over-the-counter medications • Obtaining prescription and over-the-counter medications online • Misuse and abuse of prescription and over-the-counter medications

28. Transit industry response • Many transit systems have initiated/enhanced their programs • Established policies • Created training programs • Implemented reporting mechanisms

29. NTSB RESPONSE • Applauded FTA for its progress and leadership • All but one of NTSB’s recommendations have been met • One outstanding concern • FTA, in concert with other US DOT modal administrations should establish a comprehensive toxicological testing requirement for a sample of fatal transit accidents to determine the role of prescription and over-the-counter medications • FTA needs to establish a standardized method for collecting and analyzing data that provides insight into the role of prescription and over-the-counter medications on fatal accidents within the transit industry

30. What is next?

31. FTA plan of action • Develop three-year snapshot of transit industry safety record • NTD fatal accident source data • NTSB transit accident case summaries • FTA drug and alcohol audit reports • Identify and evaluate causal methods used by other industries • FMCSA • FRA • NTSB

32. FTA plan of action • Elicit information from industry • Web-based questionnaire • Policy • Education and training • Employee use reporting methodology • Medical practitioner involvement • CDL physicals • Accident investigation methodology • Post-accident testing • Causal and contributing factors identification process • Post-accident fitness for duty assessments

33. FTA plan of action • In-depth interviews • Internal data collection procedure • Accident investigation procedure • Accident reports • Employee Rx/OTC records • Conduct confidential survey of employees involved in fatal accidents • Evaluate large system case studies • Obtain input from advisory panel • Transit industry professionals • Medical experts

34. FTA plan of action • Recommend data collection methodologies • Identify regulatory modifications • Revise/update toolkit

35. How can you participate? • Complete web-based survey • Make FTA aware of your approach – effective, cost beneficial • Volunteer to be on the advisory panel