prescription and over-the-counter medications

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PRESCRIPTION AND OVER-THE-COUNTER MEDICATIONS

4TH Annual FTA Drug and Alcohol Program National Conference

Nashville, TN

Presented by:Robbie L. Sarles

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FTA Disclaimer

The information contained in this presentation does not constitute Federal Regulations. Sound medical knowledge and understanding of the pharmacological properties of the prescription and over-the-counter medications, and detailed knowledge of an employee’s medical history and safety-sensitive job duties must guide the final assessment of potential risks to the public.

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Purpose of the Rx/OTC Presentation

The Purpose IS: Safety Technical Assistance

The Purpose is NOT: Drug and Alcohol

Testing Regulation A list of

Approved/Not Approved Medications

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History and Background

The Challenge from FTA: Following a NTSB directive, the FTA issued a

challenge to all FTA grant recipients to:

Review policies related to employees’ use of Rx/OTC medications that could potentially compromise public safety; and

Educate transit operators about the risks associated with the use of prescription and over-the-counter medications

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History and Background

The FTA Prescription and Over-the-Counter Toolkit (issued in 2003):

Designed to help educate transit systems about the potential safety risks associated with Rx/OTC medications use by transit system employees

Contained policies, procedures, training aids, and post-accident procedures

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Current Status

An FTA assessment of the status of Rx/OTC medications policies and procedures implemented by its recipients. It includes:

Extensive data gathering and analysis process; and

National evaluation of policies, procedures, and post-accident investigations utilized by FTA recipients.

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Definitions

Prescription drugs (Rx) are medications which require written authorization for use by a healthcare professional whose license permits them to prescribe medication.

The prescription must include the patient’s name, name of the substance, quantity/amount to be dispensed, instructions on frequency and method of administration, refills, and date.

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Common Types of Rx Medications

Antidepressants and Psychoactive Medication Relieves depression and other psychological

conditions

Antihistamines Reduce allergy and cold symptoms – also treat

insomnia

Anti-inflammatory/Pain Medication Relieves pain

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Motion Sickness Medication Relieves motion sickness

Muscle Relaxants Relieves sore tight muscles

Steroids Controls bodily functions

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Stimulants Causes user to be more alert

Tranquilizers and Sedatives Relieves anxiety, stress, and insomnia

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Anti-inflammatory/Pain Medication Relieves pain

Antidepressants and Psychoactive Medication Relieves depression and other psychological

conditions

Antihistamines Reduce allergy and cold symptoms – also treat

insomnia

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Definitions

Over-the-Counter (OTC) medications are any legal, non-prescription substance taken for relief of discomforting symptoms.

May include capsules, powders, tablets, or liquids.

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Common Types of OTC Medications

Pain relief/fever reducer Colds/Flu medication Appetite suppressants Bowel preparations Sleeping aids Stimulants

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Cause for Concern

Some side effects of Rx and OTC medications can be a safety issue when taken by safety-sensitive employees.

Side effects can Include:Agitation Dizziness

Anxiety Disorientation

Blurred vision Double vision

Breathing difficulty Drowsiness

Chest pain Emotional instability

Chest tightness False sense of well being

Confusion Fatigue

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Current FTA Assessment Strategies

A three step approach was used to gather data:

Step 1: Conduct a Data Search National Transit Database (NTD)

• Definitions

• Accident Classifications

National Transit Safety Board• Accident Causal Factors – Information about health factors

was limited to toxicology reports, employee interviews, and medical records.

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Current FTA Assessment Strategies

FMCSA Truck Causation Study• National, Multi-Year Study

Mandated by Motor Carrier Safety Improvement Act of 1999 (MCSIA)

• Conclusions 967 Crashes were studied. Top 4 factors were driver related,

not vehicle related (1. Rx drug use; 2. Traveling too fast; 3. Unfamiliar with road; 4. OTC drug use)

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Assessment Strategies, Cont’d

Step 2: Transit System Surveys Surveys were posted on FTA website

• Survey 1: Post Accident http://transit-safety.volpe.dot.gov/survey1

• Survey 2: Rx/OTC Policies http://transit-safety.volpe.dot.gov/survey2.

Step 3: Transit System Interviews One-on-One Interviews

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Survey Implementation

Announcements and Testing: Surveys were tested in January 2009

Feedback from your peers Invitations to participate in Winter 2009

Notice of the surveys were published in the FTA Winter 2009 Newsletter

Transit DAPMs were invited through State DOTs or directly contacted through the FTA

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Survey Participation

329 Systems Completed At Least One of the Surveys

20 of the 50 Largest transit systems (FTA-covered employees) responded

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Survey Analysis:Policies and Procedures

Prescription and Over-the-Counter Medication Policies and Procedures

186 Completed Surveys

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Policies and Procedures

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Rx/OTC Medication Transit Policies

63% - Part of our organization’s Substance Abuse Policy.

27% - Do not have an Rx/OTC Policy.

8% - Stand alone policy.

2% - Covered under another entity’s policy.

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Rx/OTC Medications as Part of Substance Abuse Policy

“While the use of legally prescribed drugs and non-

prescription medications are not prohibited, employees

must understand they have a responsibility to notify their supervisor if they are taking

any medication which indicates that mental

functioning, motor skills, or judgment may be adversely

effected.”

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“It is encouraged that you make sure your physician is fully aware of your medical history and any other drug you are currently taking. Read warning labels and take medications exactly as prescribed.”

“It is encouraged that you make sure your physician is fully aware of your medical history and any other drug you are currently taking. Read warning labels and take medications exactly as prescribed.”

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“Employees should consult with their

physician or pharmacist regarding

over the counter medication and check the alcohol content of

medications.”

“Employees should consult with their

physician or pharmacist regarding

over the counter medication and check the alcohol content of

medications.”

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“Employees are not prohibited from the appropriate use of lawfully-prescribed

drugs or non-prescription over-the-counter (OTC) medications. However,

the use or consumption of any substance, including prescription and non-

prescription medication, which carries a warning label indicating that mental functioning, motor skills, or judgment

may be adversely affected must be reported, in advance of such use or

consumption, to the Policy Administrator.”

“Employees are not prohibited from the appropriate use of lawfully-prescribed

drugs or non-prescription over-the-counter (OTC) medications. However,

the use or consumption of any substance, including prescription and non-

prescription medication, which carries a warning label indicating that mental functioning, motor skills, or judgment

may be adversely affected must be reported, in advance of such use or

consumption, to the Policy Administrator.”

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“Use of a controlled substance in accordance with the instructions of a physician will only be considered when the employee's physician has supplied a written statement ....advising that the substance does not reasonably, affect the employees ability to safely operate a service vehicle. If ..... the employees performance may be affected or compromised by the use of the prescribed medication, the employee will be considered unfit for duty and the Medical Authority will advise the employee and the employee's supervisor that he/she is temporarily medically disqualified.”

“Use of a controlled substance in accordance with the instructions of a physician will only be considered when the employee's physician has supplied a written statement ....advising that the substance does not reasonably, affect the employees ability to safely operate a service vehicle. If ..... the employees performance may be affected or compromised by the use of the prescribed medication, the employee will be considered unfit for duty and the Medical Authority will advise the employee and the employee's supervisor that he/she is temporarily medically disqualified.”

Provided by: Triangle Transit, NC

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“Safety-sensitive employees who fail to report their use of prescription and over the counter medication and subsequently have a positive drug or alcohol screen are subject to discipline, up to and including discharge. It is imperative that employees inform their physicians and/or pharmacists of their employment requirements regarding fitness for duty prior to obtaining medication.”

“Safety-sensitive employees who fail to report their use of prescription and over the counter medication and subsequently have a positive drug or alcohol screen are subject to discipline, up to and including discharge. It is imperative that employees inform their physicians and/or pharmacists of their employment requirements regarding fitness for duty prior to obtaining medication.”

Provided by: Triangle Transit, NC

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Stand Alone Policy“...Policy is the responsibility of TriMet’s Occupational Health Physician in conjunction with all managers and supervisors...”

“...Policy is the responsibility of TriMet’s Occupational Health Physician in conjunction with all managers and supervisors...”

Prohibited behaviors:....Prohibited behaviors:....

Provided by TriMet, Portland, OR

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Stand Alone Policy-BrochureMedications of Concern if used while Performing SS work.

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Stand Alone Policy-Brochure

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Rx/OTC Medications as State Traffic Law

“The New York State Department of Motor Vehicles Commissioner’s Regulations Part 6 states the following:

(a) A person is physically qualified to drive a bus if he or she does NOT use an amphetamine, narcotic, or any habit-forming drug. This regulation applies to whether or not a physician has prescribed the disqualifying drug.”

Provided by Niagara Frontier Transit, NY

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Rx/OTC Medications as State Traffic Law

Article 19-A of New York State Traffic Law:

“Accordingly, no operator who is using a prescription or non-prescription amphetamine, narcotic, or other habit-forming drug will be certified to operate a bus, train or MetroLink passenger vehicle for NFTA/Metro.”

Provided by Niagara Frontier Transit, NY

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Reporting Requirements

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Communicating with the Physicians

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Physician’s Note for Fitness for Duty

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15% of Survey participants provide a Fitness for Duty Form for Rx Medications.

7% of survey participants provide a Fitness for Duty Form for OTC Medications.

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The form above must be attached to the physician’s letterhead or voided prescription form.

The form above must be attached to the physician’s letterhead or voided prescription form. Provided by Niagara

Frontier

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Essential Job Functions Q&A

Question? How are essential job functions communicated to the

prescribing physicians?• Employee’s responsibility?• A copy of the employee’s job description is provided to Dr?• Included on Fitness for Duty Form provided to Dr?

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Communicating with the Physician

Answer: Nearly 44% of respondents said that it is the employee’s

responsibility to communicate with physician. Approximately 26% have no process in place. Approximately 20% provide an employee’s job description to

the physician.

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“Physician Instructions”

“Physician Instructions”

“List of medications of concern....”“List of medications of concern....”

“Safety-Sensitive Job Functions”

“Safety-Sensitive Job Functions”

Provided by JAUNT

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“Please Check One...

Employee may not perform safety-sensitive duties.-or-Employee is released to perform safety-sensitive duties while taking this medication.”

“Please Check One...

Employee may not perform safety-sensitive duties.-or-Employee is released to perform safety-sensitive duties while taking this medication.”

Provided by JAUNT

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“Physician Completes”“Physician Completes”

“I have reviewed employee’s medical records and am familiar with employee’s job duties.”

“I have reviewed employee’s medical records and am familiar with employee’s job duties.”

Provided by Prairie Five CAC (Montevideo, MN)

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Tri-Met Safety-Sensitive Employee

Prescription Drug Use Form

-Employee Signature

-Physician provides list of medications and start/end date of prescription

Tri-Met Safety-Sensitive Employee

Prescription Drug Use Form

-Employee Signature

-Physician provides list of medications and start/end date of prescription

Provided by TriMet

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Consequences

What Are the Consequences for an Employee who Fails to Report Rx/OTC use? Progressive Discipline Up to and Including Suspension – 40% No Action Taken – 27% Verbal Warning or Reprimand Only – 12% Written Warning or Reprimand Only – 4% Other – 17%

• “Violation of union rule books.”

• “Employee can be treated as positive test on drug screen.”

• “Depends upon the circumstances.”

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Attendance Policies

Does Your System Have an Attendance Policy for Rx/OTC Medication Use? Yes

Prescription 13%

Over-The-Counter 7%

Does Your Attendance Policy Have a Limitation on Use of Sick Leave for

Rx/OTC Medication Use? Yes

Prescription 7%

Over-The-Counter 2%

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Attendance Policies

Sample attendance policies included: “After 3-days continuous absence, requires a doctor’s

statement to return to work.” “Any Rx/OTC medication that is prescribed by a

physician cannot have any restrictions for duty, or the employee must take sick leave until they are off of the medication and cleared by the physician.”

“Sick leave use has a limit and employees may use sick leave to address medication use but cannot exceed maximum sick hours available. Physician report is required.”

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Attendance Policies

What is used to determine if an employee should continue to perform his/her safety-sensitive duties? 60% use the prescribing physician’s medical assessment. 13% use the transit system’s physician’s medical assessment. 13% use the management’s common medical knowledge. 4% use a physician’s desk reference. 10% use some other source.

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Employee Awareness Training

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Training Approach

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Amount of Time in Training

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Components of Employee Training

Employee training typically includes: Overview of System’s Rx/OTC Policy

• What is included in the policy?

• What are employee’s responsibilities?

Procedures for Obtaining Medical Authorization• Who is the Medical Authority?

• When is Medical Authorization Required?

Notification/Reporting Requirements. Required Forms. Consequences of Policy Violations.

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Components of Employee Training (cont’d)

Employee training typically includes: Define Rx/OTC medications Notification/Reporting Requirements

• Who must the employee notify when taking Rx and/or OTC medications?

• When must notification occur?

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Employee training typically includes (cont’d): Required Forms

• What documentation is required?

• Who must approve/complete required forms?

• When are forms required?

Consequences of Policy Violations• What are the possibilities?

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Sick Leave/PTO Must employee’s take his or her sick leave or PTO when

using Rx/OTC medications? Are there any other alternatives? Is there a limit on the amount of sick leave/PTO that can be

used?

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How to Read Labels on OTC and Rx medications• http://www.consumer-health.com/services/cons_take54.ht

m

• http://www.fda.gov/medwatch/safety.htm

• http://www.fda.gov/buyonlineguide/OTClabel.htm

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Components of Employee Training Reading Labels (Cont’d)

New labels for OTC medications have detailed usage and warning information so consumers can properly choose and use products.

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Side Effects that are of Concern. http://www.drugs.com/sfx/ http://www.fda.gov/cder/Offices/ODS/medication_guides.htm http://www.rxlist.com

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Materials for Rx/OTC Training

Sample Materials:• Videos

• Printed Materials

• Power Point Presentations

• Awareness Pamphlets

• Other

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Fitness For Duty Exam

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Physical Exam Requirements

A majority of systems use the CDL physical exam. And, most reported that CDL physicals are not being performed in a manner that successfully assesses worker Fitness for Duty.

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Post Accident Testing

Survey Results for Prescription and Over-the-Counter Medication Post Accident Testing 281 of Completed Surveys

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Total Accidents in CY 2005-2007

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Post Accident Fitness For Duty

33% Conduct medical assessment and employee fitness for duty only when the employee receives medical treatment.

30% Conduct medical assessment and fitness for duty evaluation for all major accidents even when employee does not receive medical treatment.

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45% Address medical issues with employee during accident investigation procedures

41% Address use of Rx medication with employee during accident investigation procedure.

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39% Address use of OTC medication during accident investigation procedure

41% Address fitness for duty as part of Worker’s Compensation assessment.

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Post Accident Investigation

Who conducts your accident investigations?• 57% Management/Supervisor

• 20% Law enforcement accident report

• 10% Road/Operations Supervisor

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Post Accident Investigation

Causal or contributing factors addressed in accident investigation procedures:

• Driver error = 12%

• Vehicle failure (tires, brakes, etc.) = 12%

• Road conditions = 12%

• Weather = 12%

• Illegal drug use = 10%

• Alcohol use = 10%

• Driver illness/health = 9%

• Driver fatigue = 8%

• Rx medication use = 7%

• OTC medication use = 6%

• Other = 1%

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Post Accident Inquiry Q&A

Question: How do you inquire about the employees health,

Rx and OTC medication use?• Part of standard forms/process

• Investigator may pursue based on circumstances of accident

• Don’t inquire

• Follow-up, if information is volunteered by employee

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Post Accident Inquiry Q & A

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Post Accident Causal Determination

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Process for Post Accident Fitness for Duty Testing

Process for Assessing Post Accident Fitness for Duty.

Example: “Post Accident Drug and Alcohol Test Decision Documentation Form” ~ Livingston Essential (Howell, MI):

“20. Did the employee indicate recent use of prescription or over-the-counter medication? Complete the Prescription/OTC Medication Post Accident Investigation forms.)”

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“List all medications (including over the counter medications) used regularly or recently.”

“List all medications (including over the counter medications) used regularly or recently.”

“Medications ARE acceptable...”

“Medications are NOT acceptable...”

“Medications ARE acceptable...”

“Medications are NOT acceptable...”

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“Complete anytime the initial accident investigation indicates that Rx or OTC drugs could be a contributing factor to the accident...”

“Complete anytime the initial accident investigation indicates that Rx or OTC drugs could be a contributing factor to the accident...”

“...list all Rx and OTC drugs you are currently taking or have taken within the past 7 days.”..dosage...frequency

“...list all Rx and OTC drugs you are currently taking or have taken within the past 7 days.”..dosage...frequency

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Next Steps

Further Input Surveys are still open:

• Survey 1: Post Accident • http://transit-safety.volpe.dot.gov/survey1

• Survey 2: Rx/OTC Policies • http://transit-safety.volpe.dot.gov/survey2

Further Analysis Comparing actual accidents to Rx/OTC use

• Definitions• Accident Classifications• Accident Data and Causal Factors

Convening an Advisory Panel Recommendations to FTA

prescription and over-the-counter medications

Documents