Prescription and OvertheCounter Medications

1
Prescription and Over-the-Counter Medications

• Presented for 3rd Annual FTA Drug and Alcohol
  National Conference
• April 30 May 1, 2008
• Presented By Robbie Sarles

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
  pilots 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,
  Physicians 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 elses 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 systems Rx/OTC policy
• An overview of your systems 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 (contd)
• Form may be reviewed by the employers
  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 NTSBs 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