# Presentation: 487376

## FTA Prescription and Over-The-Counter Drug Use In The Transit Industry

**Presented by: Robbie L. Sarles**

## 	The information provided herein should be used only as guidance and does not constitute Federal Regulations.  Sound medical knowledge and understanding of the pharmacological properties of 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.

- FTA Disclaimer

## Overview

- National Transportation Safety Board (NTSB) Directive
- Overview of the issue
- Developing an Rx/OTC policy
- Elements
- Roles and responsibilities
- Establishing medical review procedures
- Employee Rx/OTC training

**Notes:**
NTSB Directive to all transit vehicle operators from the January 13, 2000

## 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

**Notes:**
NTSB Directive to all transit vehicle operators from the January 13, 2000

## Definitions

- Prescription drugs (Rx) are medications which require written authorization for use by a healthcare professional whose license permits them to prescribe medication
- Must include:
- Patient’s name
- Name of substance
- Quantity/amount dispensed
- Instructions on dosage, frequency, and method of administration
- Refills
- Date

**Notes:**
Common types of prescription medication include:
Anti-inflammatory/Pain Medication (Relieves pain);
Antidepressants and Psychoactive Medication (Relieves depression and other psychological conditions);
Antihistamines (Reduces allergy & cold symptoms – also used to treat insomnia);
Stimulants (Causes user to be more alert); and
Tranquilizers & Sedatives (Relieves anxiety, stress & insomnia).

## 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

**Notes:**
Common over-the-counter medications include:
Pain relief/fever reducer
Colds/Flu medication
Appetite Suppressants
Bowel Preparations
Sleeping Aids
Stimulants

## Cause for Concern

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

- Agitation
- Anxiety
- Blurred vision
- Breathing difficulty
- Chest pain
- Chest tightness
- Confusion

- Dizziness
- Disorientation
- Double vision
- Drowsiness
- Emotional instability
- False sense of well being
- Fatigue

**Notes:**
Transit systems should consult with competent medical professionals if deciding to use a side effect list to develop a medication list.  The FTA is not saying if the medication causes these side effects they can not be used.  Remind the participants that these side effects have the potential to affect employees performing safety sensitive functions.

Side effects of both Rx and OTC medications vary greatly and can include a number of side effects, including:
Agitation, Anxiety, Blurred vision, Breathing difficulty, Chest pain, Chest tightness, Confusion, Dizziness, Disorientation, Double vision, Drowsiness, Disorientation, Emotional instability, False sense of well being, Fatigue, Fever, Hallucinations, Severe Headache, Hyperventilation, Insomnia, Light headedness, Muscle cramps/spasms, Nausea/vomiting, Nervousness, Palpitations, Poor coordination, Rapid or irregular heart beat, Restlessness, Ringing in the ears, Sedation, Seizures, Severe diarrhea, Tremors, and Weakness.

## Cause for Concern (Cont’d)

- Hallucinations
- Severe headache
- Hyperventilation
- Insomnia
- Light headedness
- Muscle cramps/spasms
- Nausea/vomiting
- Nervousness

- Palpitations
- Poor coordination
- Rapid or irregular heart beat
- Restlessness
- Ringing in the ears
- Sedation
- Seizures
- Severe diarrhea
- Tremors
- Weakness

## 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

**Notes:**
The goal of an Rx/OTC policy is not 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.  Rather, it should be to ensure that those receiving medical attention are aware of the potential impacts on safety of the medication that they are taking, and to establish a process for addressing safety-sensitive work when employees are taking medication.

## FTA Recommended Policy Elements (Cont’d)

- Purpose of policy (cont’d) - 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
- Define processes and procedures that implement the policy, such as:
- Medical review/authorization
- Reporting
- Use of leave benefits; limitations

**Notes:**
It will fall to Transit agency management to establish policy and procedures.  These are likely to include procedures for:
Determining content/process for medical review;
Defining an employer notification process;
Determining a process for employer physician/MRO review.
Establishing record keeping, information disclosure and confidentiality protection procedures;
Establishing procedures for removing employees from duty;
Establishing consequences for policy violation; and
Incorporating into the existing absenteeism policy topics such as type of leave and limitations on leave.

## FTA Recommended Policy Elements (Cont’d)

- 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

**Notes:**
Many transit systems have failed to include specific discipline in their Rx/OTC policies.  Recommend to the participants that they need to define specific provisions to the policy to avoid having a big dog with no teeth.  (a lot of bark but no bite)

## FTA Recommended Policy Elements (Cont’d)

- Ensure that the policy emphasizes and maintains confidentiality
- Records
- Interaction with medical practitioner

**Notes:**
Any records or documentation generated as part of the RX/OTC program are MEDICAL records not drug and alcohol records.  Ensure participants understand that they must maintain the RX/OTC records separate from the Drug and Alcohol records.

## Suggested Medical Review Process

- Conduct a baseline medical assessment of safety-sensitive employees - CDL holders; expand scope and rigor of CDL    biannual physical - Non-CDL holders; introduce biannual    examination that mimics CDL physicals

## Suggested Medical Review Process (Cont’d)

- Biannual physical to include:  - Assessment of medical fitness for the conduct    of safety-sensitive duties
- Physical
- Mental
- 	 - List of all current prescriptions - List of all commonly used prescriptions - List of all commonly used over-the-counter    medications - List of all commonly used dietary supplements    / herbal remedies

## Suggested Medical Review Process (Cont’d)

- Review in light of safety-sensitive job duties - Essential job functions
- Biannual physical results: - Approved - Approved with conditions - Medically disqualified
- Temporary
- Permanent

## Suggested Medical Review Process (Cont’d)

- Limit number of medical practitioners
- Establish high standard and philosophy of   exams
- Notification / education of medical practitioner - Responsibility to protect public safety - Safety-sensitive job responsibilities

## Employee Report New Medications

- If medication is on list provided as part of exam, provide to human resources to verify:  no additional action
- If medication is not on list provided as part of the exam: - Employee should notify employer - Contact designated physician - Physician reviews in light of medical history    contained on physical documentation
- Documentation

## Suggested Employer Physician Responsibilities

- Provide information on Rx/OTC hazards
- Serve as resource by responding to questions
- Consult with prescribing medical practitioner as appropriate and make final determination
- Consult with prescribing medical practitioners as needed

## Suggested Management/ Supervisor Responsibilities

- Establish policy and procedures
- Determine content/process for medical review
- Define employer notification process
- Determine process for employer physician/MRO review
- Institute employee Rx/OTC awareness and training program
- Establish consequences for policy violation

## Establish record keeping, information disclosure and confidentiality protection procedures
Based on medical review, determine if employee is authorized to perform safety-sensitive duties
Establish procedures for removing employees from duty

- Based on medical review, determine if employee is authorized to perform safety-sensitive duties
- Establish procedures for removing employees from duty

- Suggested Management/ Supervisor Responsibilities

## Suggested Management/ Supervisor Responsibilities

- Incorporate into absenteeism policy
- Type of leave
- Limitations on leave
- Use Rx/OTC program as a method for improving employee and public safety

## Suggested Employee Roles and Responsibilities

- Be aware of medical condition and implications for job
- Be aware of possible Rx/OTC side effects which may compromise safety
- Read warning labels/side effects
- Rx labels and warnings
- Pharmacy information summaries
- OTC Labels
- OTC Package inserts

**Notes:**
In understanding medication, the types of things an employee would be expected to be aware of could include:
Dosage
Frequency
Routes of administration – The way the medication is taken, oral, topical, or injected
Possible side effects
Interaction with other drugs and/or alcohol
Impact on other medical conditions

In this section remind participants that if the label lists alcohol as an ingredient that use before the performance of a safety-sensitive function is prohibited by Part 655.

## Employee Roles and Responsibilities (Cont’d)

- Discuss Rx or OTC with prescribing/ medical practitioner or pharmacist
- Dosage
- Frequency
- Method of use (capsule, liquid, suppository)
- Possible side effects
- Interaction with other medications
- Impact on other medical condition

**Notes:**
Method of use may include oral, topical, or injection.

## Employee Roles and Responsibilities (Cont’d)

- Inform medical practitioner of:
- Safety-sensitive job duties
- Other Rx, OTC, vitamins, herbal remedies, dietary supplements
- Medical history
- Previous experience with Rx/OTC’s
- Medical treatment and prescriptions given by other medical practitioners

## Employee Roles and Responsibilities (Cont’d)

- Questions for medical practitioner:
- Enquire into alternative dosage schedules that minimize impact on work performance (i.e., dose at end of shift rather than before)
- Enquire into alternative treatment options that do not jeopardize safety

## When ill or injured obtain appropriate medical treatment
Only use medications for their intended purpose
Check the strength of the medication
Keep your medical practitioner informed of your reaction to Rx/OTC
Always take medication as directed

- Only use medications for their intended purpose
- Check the strength of the medication
- Keep your medical practitioner informed of your reaction to Rx/OTC
- Always take medication as directed

- Employee Roles and Responsibilities (Cont’d)

## Do not take larger doses than prescribed
Do not take longer than prescribed
Do not double dosage after missing a dose
Do not self-medicate with OTC or someone else’s Rx in lieu of obtaining medical treatment

- Do not take longer than prescribed
- Do not double dosage after missing a dose
- Do not self-medicate with OTC or someone else’s Rx in lieu of obtaining medical treatment

- Employee Warnings

## Do not use an expired prescription
Do not stop taking medication because you begin to feel better – take for length prescribed
Do not take for granted that a prescription is correct  
Always read the label every time you get it filled 
Make sure you have the right medication at the proper dosage 	

- Do not stop taking medication because you begin to feel better – take for length prescribed
- Do not take for granted that a prescription is correct
- Always read the label every time you get it filled
- Make sure you have the right medication at the proper dosage

- Employee Warnings

## Never combine medications in the same bottle
Never store in humid locations (bathroom)
Make sure you understand the directions
Ask questions if you don’t understand or the prescription doesn’t seem right
Use the same pharmacy
Always ask about interactions
Keep medication in original labeled bottle

- Never store in humid locations (bathroom)
- Make sure you understand the directions
- Ask questions if you don’t understand or the prescription doesn’t seem right
- Use the same pharmacy
- Always ask about interactions
- Keep medication in original labeled bottle

- Employee Warnings

**Notes:**
Humid locations may weaken or increase the strength of the medication by exposing it to the water/steam vapors.
Using the same pharmacy allows the pharmacist to keep records of medications which may interact.

## Individual often can not judge level of own impairment
Side effects may change/intensify/lessen with prolonged use
Some medications should be taken with food to minimize adverse reaction while other should be taken on an empty stomach
Changing dosage schedule (without medical practitioner approval) can alter effect

- Side effects may change/intensify/lessen with prolonged use
- Some medications should be taken with food to minimize adverse reaction while other should be taken on an empty stomach
- Changing dosage schedule (without medical practitioner approval) can alter effect

- Employee Warnings

## Monitor your reaction to the Rx/OTC

Do not perform safety sensitive duty if impaired

- Do not perform safety sensitive duty if impaired

- Employee Warnings

## Summary

The primary objective of developing and implementing a Prescription/OTC policy and training employees, is to enhance the safety of employees, customers, and the public

Employees must accept responsibility for their own medical treatment
  They must also accept responsibility for protecting the public safety

- The primary objective of developing and implementing a Prescription/OTC policy and training employees, is to enhance the safety of employees, customers, and the public
- Employees must accept responsibility for their own medical treatment
-   They must also accept responsibility for protecting the public safety

**Notes:**
All information obtained for this presentation was gathered from the following sources:
The Federal Aviation Administration (Office of Aviation Medicine)
The Federal Railroad Administration
The Food and Drug Administration
All medical information was reviewed by Natalie Hartenbaum, M.D., MPH

## Relevant Web Sites

- Aviation medicine – www.aviationmedicine.com/
- Food & Drug Administration – www.fda.gov
- FDA Center for Drug Evaluation and Research –  www.fda.gov/cder/
- Agency for Healthcare Research and Quality –www.ahrq.gov
- U.S. Dept. of Health and Human Services – www.hhs.gov
- National Health Info Center – www.health.gov/nhic
- The Internet drug list –www.rxlist.com

**Notes:**
Common Rx and Potential Side Effects
(Lists of medications and potential side effects are not all-inclusive.  In all cases competent medical opinions must be sought in order to accurately determine which medication is right for the condition being treated.  Always consult a medical practitioner for potential risks and side effects based on your own medical history.)

Common Anti-inflammatory and Pain Medications
Aspirin		Talwin 		
Celebrex		Talacet
Darvon/Darvocet		Tylenol with codeine
Demerol		Naprosyn
Indocin		Ultram
Methadone		Vioxx
Morphine		Vicodin
Motrin		Voltaren
Percodan/Percocet
Anti-inflammatory and Pain Medication Possible Side Effects Anxiety		Fatigue
Breathing difficulties	Lightheadedness
Constipation		Nausea/vomiting
Chest tightness		Palpitations
Dizziness		Sedation
Drowsiness		Restlessness
False sense of well being	Weakness

Common Antidepressants and Psychoactive Medications 	
Adapin		Nardil
Buspar		Pamelor
Celexa		Paxil
Desyrel		Prozac
Elavil		Tofranil
Effexor                            	Vivactil                       	
Limbitrol		Zoloft
Lithium	
Antidepressant and Psychoactive Medication Possible Side Effects
Agitation		Drowsiness
Anxiety		Nausea/vomiting
Blurred vision		Rapid heartbeat
Chest pain		Restlessness
Confusion		Seizures
Dizziness		Weakness