1. Medications and Safety Concerns Donna R. Smith, Ph.D. Regulatory Affairs and Program Development Officer FirstLab, Inc.

2. Photo Courtesy of the New Orleans Police Department

3. St. Petersburg, FL Sep 12, 2007 Six people injured in PSTA bus crash when driver crashed through trees & cars, and ended up inside a check cashing business in St. Petersburg Police charged driver with felony DUI in October after receiving his blood test results, which showed he had Methadone, Alprazolam (Xanex) and Lorazepam in his system. Driver was acting erratically prior to and after crash according to witnesses Driver admitted taking medications to treat back pain Driver had passed all DOT drug tests Driver was terminated for failure to disclose medications to PSTA as required by their policy

4. New Orleans Bus Accident NTSB Report Probable cause −Driver’s severe medical conditions −Medical certification system’s inability to remove driver from service Contributing factors −Fatigue −Use of sedating antihistamine −Use of Marijuana Released to work by several treating physicians

5. Legal vs. Illegal Drugs NTSB, ONDCP, SAMHSA and other government agency studies indicate that abuse and misuse of prescription controlled substance medications is more prevalent than “illicit” drug use. Dramatic increase in past decade in use of medications for chronic pain, anxiety, sleep disorders, & attention deficit disorders. Abuse and misuse of prescribed meds takes several forms: −Use for longer than medically indicated −Use in dosages higher than recommended −Use in combination with other drugs & OTC meds −Use when performing tasks that are contraindicated

6. DOT Drug Testing Limitations DOT drug testing is limited by OTETA to Schedule I & II drug classes Most painkillers, anxiety drugs, sleep aids, etc. are Schedule III, IV & V drugs Largest class of painkillers, synthetic opioids, are not detected in DOT testing: −Oxycodone, h ydrocodone, hydromorphone, oxymorphone, methadone Benzodiazepines, barbiturates, and propoxyphene are also not detected in DOT testing Urine drug test does not indicate impairment, nor can it determine abuse or misuse of prescribed medications

7. NTSB Directive to FTA Educate transit systems - Potential safety risks of Rx and OTC Require notification of Rx/OTC use by safety- sensitive employees Incorporate qualified medical personnel in Fitness for Duty Assessment Train employees on roles and responsibilities

8. MRO Safety Concern on DOT Drug Test Issued by MRO when laboratory positive drug test is due to use of a prescribed or medically administered drug and MRO believes: −Use of prescribed medication poses a significant safety risk, or −Medical condition for which medication is prescribed may pose a significant safety risk Test result will be reported as “Negative” with MRO comment of a safety concern Employee is informed by MRO that safety concern is being reported to employer

9. MRO Notice to Donor MRO notifies donor that he/she can submit (within 5 days) documentation from prescribing physician that demonstrates: −Medication has been discontinued, or −changed to one that does not cause concern If MRO receives such documentation, employer will be notified that safety concern is removed

10. Safety Concerns from Medical Review Officer Review The medical review officer is required by 49CFR Part 40.327 to provide to third parties, drug test results and medical information affecting the performance of safety-sensitive duties which are obtained during the verification process. Employee Social Security or ID Date of Specimen Collection Date of MRO determination As a result of the MRO verification process, the MRO has determined that in addition to the drug test result there is a: Safety Concern – Medication –Employee has reported the use of medication(s) that may pose significant safety risk or may make the employee medically unqualified for a safety-sensitive position. In accordance with §40.135 (c) the employee has been notified that they have 5 days for the prescribing physician to contact the MRO to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. Employer will be notified if this information is provided. If you do not receive an amended report, additional information that the medication was discontinued or changed was not provided Additional information obtained from the treating provider on, that medication of concern has been discontinued or changed to one that does not present a safety concern Additional information obtained from the treating provider on, that medication of concern has been changed, but to one that also presents a safety concern Safety Concern – Medical Condition – Employee has disclosed a medical condition that may have an adverse impact on the safe performance of safety-sensitive duties--Recommend evaluation by Occupational Health professional Safety Concern – Medical Condition – Employee has disclosed a medical condition that may result in the employee not meeting Federal medical standards - Recommend evaluation by Occupational Health professional/Medical Examiner. Medical Review Officer Name: _________________________________________ Medical Review Officer Signature: _________________________________________ Date: _________________________________________

11. Employer Actions on MRO Safety Concern Options for resolving safety-concerns −Have prescribing physician provide statement that employee is able to perform safety-sensitive duties while taking medications −Have employee undergo “fitness for duty” evaluation by employer designated physician Important for transit employer to have medication policy and procedures in place MRO cannot make “fitness for duty” recommendation based on donor interview and urine drug test result

12. Medication Safety Issues Possible “impairing” effects Risks associated with medical conditions for which meds are being used Interactions with other medications and OTC products Compliance with recommended dosing −Dosage amounts −Timing of taking meds Therapeutic course; acute vs. chronic Employee lack of awareness of impairing effects

13. Medication Use Side effects of concern Somnolence Fatigue Impaired judgment Hypotension Sedation Erratic performance Impaired reflexes Dyskinesias and other neurologic dysfunction Headaches Muscle weakness Visual disturbance

15. FTA Prescription and OTC Toolkit Policies Procedures Training Aid Post-Accident Procedures Several lists of Rx and OTC medications used by various federal and private agencies References and Resources http://transit-safety.volpe.dot.gov/Publications http://transit-safety.volpe.dot.gov/safety/datesting/Presentations

16. Policy Options Responsibility is placed on the employees to report & determine their own ability to safely perform their duties while using medications Requiring authorization by medical practitioners that employee can safety perform duties while using prescribed medications Use of a list of medications to guide employees and medical practitioners on which medication may or may not be used, and those medications that must be approved for use Evaluation of employee’s fitness for duty based on prescribed medications by employer designated physician

17. Policy Considerations Employees often under-report medications used Reporting medical information to supervisors may place inappropriate level of responsibility and liability on them Lists of acceptable and unacceptable medications are difficult to keep updated and all inclusive Prescribing physicians are often unaware of employee’s duties or unwilling to risk their patient’s not being able to work If having employee’s physician authorize employee working while taking prescribed meds, statement must be specific and include understanding of employee’s duties

18. Policy Considerations Use of DOT driver medical standards or equivalent with biennial physical examinations Fitness for duty examinations by employer designated physician Review of employee medication reports or personal physician statements by employer designated medical consultant Annual review of employee’s medications/medical history Ongoing employee education and awareness efforts, emphasizing new medications, medical facts, etc.

20. FMCSA Driver Medical Standards Specifically disqualifying medications −Insulin – all forms, unless given exemption −Seizure medication −Methadone—increasingly being prescribed for chronic pain −Modafinil—stimulant used to increase wakefulness, alertness

21. Rx & OTC Drugs and Performance Pain medicines – Codeine, Darvocet, Morphine, Vicodin, oxycontin Drowsiness Slower reaction times Mental confusion Anxiety Agitation Dizziness Blurred vision Tranquilizers and Sedatives – Ativan, Diazepam, Xanax, Halcion, Valium, Drowsiness Amnesia Agitation Dizziness Weakness Unsteadiness Disorientation

22. Rx & OTC Drugs and Performance (Cont.) Muscle relaxers – Flereril, Parafon Forte, Robaxin Drowsiness Fatigue Nervousness Confusion Dizziness Visual disturbances Anti-motion sickness – Antivert, Dramimine, Phenergan Drowsiness Restlessness Hallucinations Blurred vision

23. Rx & OTC Drugs and Performance Antihistamines – Benadryl Drowsiness Slowed reactions Impaired vision Stimulants – Sudafed, ephedrine, Aderall Jitteriness Diminished concentration False sense of alertness Irritability Post-high fatigue

24. Current Issues Dramatic increase in use of controlled substance medications to treat chronic pain, anxiety, depression, attention deficit disorders, in US population Hundreds of new drugs on the market every year that have potential “impairing” effects Medication interactions are often unknown and not monitored because people get multiple medications from several physicians Aging population being prescribed more and more drugs Painkillers, tranquillizers, sleep aides readily available via the internet and “walk-in” clinics