Medications andSafety Concerns

Donna R. Smith, Ph.D.Regulatory Affairs and Program Development Officer

FirstLab, Inc.

Photo Courtesy of the New Orleans Police Department

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

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

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

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, hydrocodone, 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

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

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

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

• 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: _________________________________________•

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

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

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

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/Present

ations

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

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

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.

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

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

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

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

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