Developing and Implementing an Effective Rx/OTC Program

Developing and Implementing an Effective Rx/OTC Program
Presented by Robbie L. Sarles RLS & Associates, Inc. 9th Annual FTA Drug and Alcohol Program National Conference April 16-17, 2014

Rx/OTC Medications and Impairment Many Rx/OTC Medications Warn About Risks Related to Driving Most Are Ignored Few Talk to Their Health Care Provider (HCP) About the Impact Rx/OTC Will Have On Their Driving Additional Side Effects When Combined With Other Medications

Rx/OTC Medicationsand Impairment “Potentially Driver-Impairing” (PDI) Medications Known Effects on: Central Nervous System Blood Glucose Levels Blood Pressure Vision Other

Rx/OTC Medications and Impairment PDI Effects Include Sedation Hypoglycemia Blurred Vision Hypotension Dizziness Fainting Loss of Coordination

Rx/OTC Medicationsand Impairment 2008 NHTSA Study on Relationship Between Medications and Crashes Drivers were 1.2 to 7.5 Times More Likely to Be Involved in a Crash When Taking Medications in 35 Medication Classes 27 Had Warnings Study Created Associated Odds Ratios Expressing Risk for Crash Associated with Common Medications

Rx/OTC Medicationsand Impairment Medication-Related Impaired Driving—Medscape Education Created for Health Care Providers Inform About Effects on Driving Functional Abilities Results of Crash Analyses Epidemiologic Analysis Population Studies

Rx/OTC Medications and Impairment Medications Known to Impact Driving Central Nervous System Depressants Cardiovascular/Renal Medications Hematologic Agents Respiratory Tract Medications Hormones Gastrointestinal Agents Pain Relievers Neurologic Medications Ophthalmics Antiparasitics Central Nervous System Stimulants

Sources and Resources www.medscape.org Drugs and Human Performance Fact Sheets—USDOT NHTSA (Publication DOT HS 809 725) Exploratory Study of the Relationship Between Multiple Medications and Vehicle Crashes— USDOT/NHTSA (Publication DTNH22-02-C-05075) Categorization System for Medicinal Drugs Affecting Driving Performance—International Council on Alcohol, Drugs and Traffic Safety

Prescription Drug Misuse Prescription Drug Misuse in America—Laboratory Insights into the New Drug Epidemic—Quest Diagnostics, 2012 Majority of Americans Misuse Their Prescription Medications (63%) Selling or Giving Away Medications Combining Prescribed and Illicit Drugs Taking Non-prescribed Medications Not Following Doctors Orders Forget Too Costly Not Understanding No Longer Needed Record Keeping Self Medicating

Prescription Drug Misuse Potentially Addictive Medication Most Commonly Abused Opioid Pain Killers Central Nervous System Depressants Central Nervous System Stimulants

Nation’s Response Epidemic: Responding to America’s Prescription Drug Crisis--Office of the President Prescription Drugs are Second Most Abused Category Following Marijuana Second Leading Cause of Injury and Death Drug Overdoses Increased 300% Since 2007 Major Public Health and Public Safety Crisis

Nation’s Response National Drug Control Strategy Prescription Drug Abuse Prevention Plan Education—Raise Awareness Tracking and Monitoring Proper Medication Disposal Enforcement

Nation’s Response FDA Approved Updated Labeling Reflecting Reformulated OxyContin that Describes the Drug’s Deterrent Properties Other Formulations Will Not Have Same Labeling

Nation’s Response 2014 National Governors Conference Focus Topic Prescription Drug Abuse Project Leadership Matters Prescribing Behavior Needs to Change Disposal Options Convenient and Cost-Effective Monitoring Programs Underused Education Is Critical Treatment Is Essential Data and Evaluation Must Drive Policy and Practice

Public Transit Industry Response TRACS Committee Report Given to Administrator FTA Prescription and Over-the Counter Medications Tool Kit Updated Policies and Procedures Accident Investigation Procedures Example Forms Training Resources Best Practices Frequently Asked Questions

Suggested Rx/OTC 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

Suggested Elements of an Rx/OTC Policy Define Policy Processes and Procedures, Such as: Policy acknowledgement Medical review/authorization Post accident testing Reporting Use of leave benefits; limitations

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

Suggested Elements of an Rx/OTC Policy Ensure That the Policy Emphasizes and Maintains Confidentiality Records Interaction with medical practitioner

Suggested Elements of an Rx/OTC Policy Defined Roles and Responsibilities Employees Management/Supervisors Medical Practitioner (Physician, Dentist, Physician’s Assistant, Optometrist, Chiropractor, Other) Pharmacist Employer MRO/Physician

Policy Types Commonly Part of Drug and Alcohol Testing Policy Must Be Clearly Identified As Included In Policy Under Agency Authority

Rx/OTC Medications as Part of Drug and Alcohol Testing Policy Any provisions contained herein which are not required by 49 CFR Part 655, as amended, that have been imposed solely on the authority of the employer are designated as such in the policy document

Rx/OTC Medications as Part of Drug and Alcohol Testing Policy 7.3 Legally Prescribed and Over-the-Counter Drugs. Prescription and over-the-counter drugs can adversely affect an employee’s job performance. However, the use of Legally Prescribed Drugs and over the counter drugs is permitted under the circumstances described below. Legally Prescribed Drugs include those drugs approved and authorized for the employee by a physician for use during the course of medical treatment. For prescription drugs, the physician must issue a written prescription that clearly indicates the employee’s name, drug type, and proper dosage. San Francisco MTA Drug and Alcohol Policy

Rx/OTC Medications as Part of Drug and Alcohol Testing Policy If an employee is taking prescription and/or over-the- counter drugs, he/she must obtain a signed note from a physician that the use of this drug(s) at the prescribed or authorized dosage is consistent with the safe performance of the employee’s Safety-Sensitive duties. This note must be presented to the employee’s supervisor before Performing Safety-Sensitive duties. Failure to provide this note may result in disciplinary action. San Francisco MTA Drug and Alcohol Policy

Other Policy Types Stand Alone Policy Part of Other Comprehensive Policy Medical Issue Policy FMCSA Medical Examination Policy Fitness For Duty Medical Qualification Wellness

Industry Approach Examples Prescribing Health Care Provider (HCP) Sign-off Approach Agency Physician Review Contract In-House FMCSA CDL Medical Examination Approach Fitness-For-Duty Approach Medical Qualification Approach Wellness Approach

Prescribing HCP Approach Medical Authorization Employee obtains medical authorization form from employer Employee provides safety-sensitive job description to medical professional 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

Prescribing HCP Approach Wheels of Independence-Wisconsin All Employees Required to Report all Prescribed Medication to Management Before Duty Regardless of Job Duties All Prescriptions Regardless of Warning Label Requires Doctor’s Authorization No adverse affect on motor skills, judgment, or mental functioning Stand Down Until Doctor’s Authorization Obtained

Prescribing HCP Approach Wheels of Independence-Wisconsin All Employees Required to Report all Over-the- Counter Medication to Management Before Duty Regardless of Job Duties All OTCs With Warning Label If indicates may adversely affect motor skills, judgment, or mental functioning Requires Doctor’s Authorization Stand Down Until Doctor’s Authorization Obtained

Prescribing HCP Approach Wheels of Independence—Wisconsin Employee Responsibility Inform Doctor of Employee’s Job Function Obtain Signed Doctor’s Authorization to Return To Work and Perform State Job Duties Report to Management Prior To Performance of Job Duties Two Weeks of Sick Leave Annually

Prescribing HCP Approach Wheels of Independence-Wisconsin Reporting Process Once Notified Management Records Along with Doctor’s Authorization Maintain in Secure Cabinet Accessed Only By Management

Prescribing HCP Approach Wheels of Independence—Wisconsin Employee Training Awareness Training Incorporated Into Driver Safety Meetings

Communicating with the Physician

Communicating with the Physician “Safety-Sensitive Job Functions” “Physician Instructions” “List of medications of concern....” Provided by JAUNT

Communicating with the Physician “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

Communicating with the Physician “Physician Completes” “I have reviewed employee’s medical records and am familiar with employee’s job duties.” Provided by Prairie Five CAC (Montevideo, MN)

Communicating with the Physician 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

Medical Review Procedure

Agency Medical Review Approach Medical Authorization Employee obtains medical authorization form from employer Employee provides safety-sensitive job description to HCP Employee asks about side effects and potential impact on ability to perform duties

Agency Medical Review Approach Medical Authorization (cont’d) No Adverse Impacts – HCP Signs Release Adverse Impacts – HCP Specifies Duration Off Duty Form Reviewed by the Employer’s Physician/MRO Dialog with HCP as Needed May Overturn Authorization Decision Final

Agency Medical Review Approach Agency Medical Reviewer Physician or Nurse Practitioner Contract or In-House

FMCSA Medical Examiner Approach FMCSA Commercial Driver’s License Medical Examination FMCSA National Registry of Medical Examiners Employee Choice Employer Designation Use of Medication Reviewed at Time of Examination May Review Rx/OTC Use Between Exams

FMCSA Medical Examiner Approach Mirror FMCSR Standards for Non-CDL Holders No Substitute FMCSA Waivers Procedures No FMCSA Forms or Non-CDL Holders Focuses on Safety Part of Comprehensive Medical Examination Based on FMCSR Standards Designed Primarily for Truckers May Not Take Into Consideration Unique Transit Environment and Job Duties

Fitness For Duty Approach Stand Alone Fitness For Duty Policy Focus on Safety Ability to Perform Essential Job Duties Establish Standards and Procedures for Assessing Fitness for Duty Rx/OTC as Component of Overall Policy

Fitness For Duty Approach Los Angeles County Metropolitan Transportation Authority (LACMTA) Safe, Dependable and Efficient Service for Passengers Safe and Productive Work Environment for Employees

Fitness For Duty Approach Ensure Employees are Fit for Duty Able to Perform Essential Job Duties at All Times Without Posing a Health or Safety Risk to Themselves, Coworkers, or the Public Establish Standards and Procedures For Assessing Fitness for Duty—Mental and Physical Ability Applies to all LACMTA Employees Collective Bargaining Agreement Prevails If Conflict Rx/OTC One Portion of Comprehensive Fitness for Duty Program

Fitness For Duty Approach Job Duties Operate Metro vehicles and equipment safely and efficiently Work independently in a highly-structured environment Exercise sound judgment in stressful situations Understand and follow detailed oral and written instructions Communicate courteously and effectively with other employees and the public Decipher and successfully encounter traffic patterns flows and potential road hazards Recognize existing or potential mechanical defects, problems, or maladjustments

Fitness For Duty Approach Job Duties Continued Push, pull and lift up to 35 pounds Push and pull wheelchair up to 275 pounds Bend with both knees and back, squat and/or kneel when securing a wheelchair Quickly and accurately count money at a glance Read small printed material Perceive patrons at bus stops from great distances Read, write, speak, and understand English

Fitness For Duty Approach Rx/OTC Component Acknowledges Some Medical Conditions Require Rx/OTC Medications that Can Impair Employee’s Ability to Perform Duties Safely Employees Limited to use of Valid Prescriptions In Their Own Name

Fitness For Duty Approach Employee Responsibilities Notify Supervisor When Not Fit For Duty Follow Procedures for Reporting Rx/OTC Medications Be Aware of Medical Conditions and Job Implications Follow Rx Dosage, Frequency and Timeframe

Fitness For Duty Approach Employee Responsibilities Read Warning Labels and Cautions Be Aware of Possible Rx/OTC Side Effects That Could Compromise Safety Inform HCP Of Job Duties Inform HCP of Side Effects And Other Medications Taken

Fitness For Duty Approach Fitness For Duty Medical Examinations Pre-employment (After Offer) Transfer Into Different Position Before Rehire or Reinstatement Renew of CDL Medical Examination Following a Non-occupational Medical Leave of 30 Days or Longer Following A Serious Non-Occupation Injury or Illness Requiring Hospitalization

Fitness For Duty Approach Fitness For Duty Medical Examination Following A Medical Episode That Suggests Serious Safety Risks Chest Pains Loss of Consciousness Dizziness Blurry Vision Temporary Paralysis Extremely Elevated Blood Pressure Suspected Heart Attack Sleep Apnea Other

Fitness For Duty Approach Fitness For Duty Medical Examination Advised By A HCP or Public Health Official That Employee May Pose a Risk of Spreading a Highly Contagious, Serious Disease Comply With OSHA Requirements

Fitness For Duty Approach Fitness For Duty Medical Examinations Conducted by LACMTA Contract HCP Complete Process At One Clinic

Fitness For Duty Approach Manager/Supervisor Responsibility Apply in Fair and Consistent Manner Observe and Monitor Employees for Signs of Impairment Respect and Protect Employee’s Privacy and Confidentiality Consult With HR Regarding Possible Impairment

Fitness For Duty Approach Human Resources Responsibilities Administer Policy in Fair and Consistent Manner Respect and Protect Privacy and Confidentiality of Employees and Applicants Review Medication Reporting Forms and See Professional Medical Guidance As Needed Select, Contract and Schedule Medical Examinations

Fitness For Duty Approach Special Fitness For Duty Examinations Employee/Supervisor Observes Co-worker Impairment Manager Observes Employee Impairment Discuss Observations With Employee Record Observations and Employee’s Response Refer Employee for Medical Examination as Appropriate

Fitness For Duty Approach Confidentiality and Privacy Medical Records Are Kept Confidential and Secured Fitness For Duty Determinations Are Released to Managers and Supervisors On A Need-To-Know Basis

Fitness For Duty Approach Consequences Applicants Disqualified for Misstatements and Concealments of Relevant Medical History and Health Conditions Employees Subject to Dismissal for Misstatements or Concealments of Relevant Medical history and Health Conditions Employees Subject to Discipline For Failure To Submit Medication Reporting Forms

Medical Qualification Approach

Medical Qualification Approach Purpose Provide a safe working environment Protect the health and safety of: Employees Customers Public Identifies and intervenes when an employee may pose a threat to: Themselves Others Property

Medical Qualification Approach Indiana DOT Mandated a Comprehensive Medical Qualification (MQ) Program Effective 2011 Mirrors the requirements of FMCSA 391.41 Requires physical and cognitive assessments for all Section 5311 safety-sensitive employees and/or applicants: Hiring Process Rx/OTC Medication Policy Return to Active Status Following a qualifying accident Case-by-Case Examinations

Medical Qualification Approach MQ Program Administered by One Medical Service Provider to Assure Consistency in Performance of Evaluations Medical Determination Officer (MDO) A medical professional under contract to the Transit System Physical examination services/medical qualification assessments Cognitive examination services RX/OTC reviews At time of assessment Anytime there is a change Health history review Wellness education/health risk education

Medical Qualification Approach Job Descriptions Should List Essential job Functions Position essential duties Position summary Position physical requirements Cognitive requirements Applicable federal, state, and agency requirements Working conditions

Medical Qualification Approach Position Summary This position is a safety-sensitive position requiring the safe operation of a motor vehicle in the provision of public transit services and the effective transportation of all passengers. Performance of these duties must be conducted in compliance with all applicable DOT, federal, state, local, and system regulations, including U.S. DOT drug and alcohol testing regulations.

Medical Qualification Approach Physical Requirements Must have the ability to bend, crouch, kneel, twist, push, and pull Must have normal hearing, with the aid of corrective devices, as needed (i.e. hearing aid) Must have normal vision, with the aid of corrective devices, as needed (i.e. glasses or contacts)

Medical Qualification Approach Physical Requirements, Cont’d Must be free from fainting spells, blackouts, dizziness, or seizures Must have the ability to sit in a normal seated position for extended periods of time

Medical Qualification Approach Physical Requirements, Cont’d Must have the ability to endure extended periods of driving Must have the ability to lift up to 25 lbs Must have the ability to tolerate exposure to dust, gas, and/or fumes Must have the ability to exert up to 20-50 pounds of force, occasionally, and/or 10-26 pounds of force frequently

Medical Qualification Approach Cognitive Requirements Must have the ability to determine vehicle travel path to ensure safe and timely transportation of passengers Must have the ability to evaluate and determine proper action in situations that may pose a safety risk Must have the ability to effectively communicate, including: Strong oral and written communication skills Knowledge of English language Ability to effectively communicate required action to passengers in situations that pose a safety risk

Medical Qualification Approach Cognitive Requirements, Cont’d Must have the ability to comply with current traffic and driver safety regulations as well as all other applicable Federal, State, and local regulations and system policies Must possess strong organizational skills Must have the ability to analyze and solve problems Must have the ability to learn, understand, and follow all public transit routes/schedules

Medical Qualification Approach Working Conditions The driver’s hours of work and work schedule vary. The position requires being seated for extended periods of time while operating a motor vehicle, interrupted by frequent standing in order to assist passengers. While driving and/or assisting passengers, the driver will need to bend, crouch, kneel, twist, push, and pull. The position may also require exposure to varied weather conditions, temperatures, and light levels. The position requires frequent interaction with the public. The position may require maneuvering the vehicle in congested traffic and within areas of restricted space.

Medical Qualification Approach Medical Qualification Assessments results indicating potential problems with the performance of safety sensitive functions require a health assessment referral Vision issues Hearing issues Blood pressure issues Cardiovascular issues Sleep apnea Diabetes

Medical Qualification Approach Rx/OTC Reviews The MQ program requires individuals to report all medication use at the time of the initial assessment and anytime there is a change or addition of medications. The MQ program: Emphasizes employee responsibility for Rx and OTC medications by requiring them to submit a form for each Rx/OTC medication taken Requires signature of a physician or pharmacist for any Rx/OTC medications indicating if the medication carries any warning label that warns against operating a motor vehicle or operating machinery while taking this medication and/or carries other health advisories or contraindications Requires the MDO to review all medications at time of initial assessment and anytime a change occurs Places final responsibility for making a medical qualification determination on the MDO

Medical Qualification Approach Physical Abilities Evaluation Each individual is required to demonstrate range of motion and strength adequate to perform safety sensitive functions Physical abilities referral Cognitive Abilities Evaluation Each individual is required to successfully complete a mini cognitive test Cognitive abilities referral

Medical Qualification Approach One Year Qualification Employee is cleared to perform safety-sensitive job duties for one year Six Month Qualification Employee is cleared to perform safety-sensitive job duties for six months Three Month Qualification Employee is cleared to perform safety-sensitive job duties for three months Note: Unless there is a change in health status or a qualifying event that requires a new assessment

Medical Qualification Approach Temporarily Disqualified Employee has a condition rendering him/her unsafe to operate a commercial motor vehicle based on FMCSA 391.41 requirements. The employee is not permitted to perform safety–sensitive job duties and is issued a referral for follow-up to evaluate the assessment findings.

Medical Qualification Approach Disqualified Employee has a condition rendering him/her unsafe to operate a commercial motor vehicle based on FMCSA 391.41 requirements

Wellness Approach Focus On Changing Culture of Organization Feel Better Live Longer Stay In Job Longer Managing Stress Improve Morale

Wellness Approach Healthy Lifestyle Exercise Fitness Classes Food Choices Awareness Campaign Health Fair Cooking Classes Recipes Meeting Foods Vending Machine Foods Newsletters Include Families

Wellness Approach Raise Consciousness of Employee Health Issues Medical Conditions Prevention Treatment Rx/OTC Use Being Informed Communicating with Your HCP Discussing Alternative Treatment Options Understanding Side Effects Learning To Be Your Own Advocate

Wellness Approach Medical Care Access to Quality Care CDL Physicals Primary HCP Access to Agency Brokered HCP Proactive Use of Benefits Employer Advocate

Wellness Approach Management Support Participation Competitions Employee/Union Support Employee Wellness Coordinator Physical Fitness Challenges

Wellness Approach Focus on Achievement of Goals-Specific to Individual Short Term Weight Loss Miles Walked Exercise Program Participation Frequency Smoking Cessation Programs Long Term Biometric Assessments Reduction of BMI Lowering Blood Pressure Reducing Number and Strength of Medications

Wellness Approach Financial Rewards For Meeting Goals Funded Through Insurance Wellness Programs Employee Driven Outcomes

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

Suggested Employee Awareness Training May Conduct Rx/OTC Training as a Stand-Alone Training Course or as One Element of the Regular Drug and Alcohol Awareness training Always Have Resource Material Available If possible have medical practitioner involved in training and/or available for questions Posts on bulletin boards Hotlines/Nurse help-lines Determine who employees may call for questions MRO Other medical practitioner

Suggested Employee Awareness Training Training Elements An overview of your system’s Rx/OTC policy An overview of your system’s procedures Medical authorization Notification/reporting Forms if applicable Consequences of policy violations Leave policy Sick leave/paid time off Limitations on use

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

Suggested Employee Awareness Training Training Elements Medication list, if applicable Approved medications Medications which require authorization Medications not approved for use

Suggested Employee Awareness Training AAA Foundation for Traffic and Safety Roadwise Rx Free, Confidential Tool Input All Medications, OTC, and Herbal Supplements Provides Feedback on Side Effects Interactions with Other Medications Interactions with Food

Suggested Employee Awareness Training Affects on Safe Driving Identifies Side Effects that Can Impact Safe Driving Medication Dosage and Timing to Maximize Your Ability to Drive Safely http://senior driving.aaa.com/medical-conditions-medications/RoadWise-RX

Program Enforcement Policy Must Address Consequences for Failure to Comply Employee acknowledgement Incident documentation records Must Enact and Apply Program Uniformly and Consistently On-Going Employee and Staff Awareness Training

Consequences What Are the Consequences for an Employee Who Fails to Report Rx/OTC use? Progressive discipline up to and including suspension Verbal warning or reprimand Written warning or reprimand Other “Employee can be treated as positive test on drug screen”

Consequences Wheels of Independence—Wisconsin Disciplinary action Failure to report Removal from duty—Return dependent on obtaining doctor’s authorization 1st Occurrence—Suspension warning 2nd Occurrence—Three day suspension 3rd Occurrence– Termination

Rx/OTC Toolkit Updated February 2012 Added appeal policy and procedure Added updated Reasonable Suspicion Determination Form Added Post Accident Model Procedures 10 plus 2 Post Accident testing Updated Post Accident Medication Investigation Form Toolkit available at: http://transit-safety.volpe.dot.gov/Publications

Developing and Implementing an Effective Rx/OTC Program