1. Medical Qualification
Fitness for Duty
Prescription/Over-the-Counter Medication Use
and
Medical Qualification
Robbie L. Sarles
RLS & Associates, Inc.
May 31, 2012
NTSB challenged FTA to address Rx/OTC medication use as a safety concern for transit
Status of the industry, not necessarily “best practices.” 1

2. History
2002: National Transportation Safety Board (NTSB) challenge to all FTA grant recipients:
Review Rx/OTC Policies.
Educate operators of potential risks associated with Rx/OTC use.
2003: FTA Released Rx/OTC Medication Toolkit:
“State-Of-The-Practice” at that time.

3. History NTSB Satisfied by Responses, but:
Further research needed to establish nature of relationship between Rx/OTC medications and transit accidents.

4. History 2009: RLS & Associates, Inc. Conducted 2 Surveys:
Gauge progress on Rx/OTC policies & procedures.
Inquire about accident investigation practices.
Update the FTA Rx/OTC Medication Toolkit.

5. History Survey Respondents indicated:
Rx/OTC policies in place, but were limited in scope and rarely enforced.
Most were not collecting Rx/OTC medication information.
If Rx/OTC medication information was collected, little was done with it.
No correlation between that information and accident investigations.

6. History 2009 Rx/OTC Survey Recommendations:
Standardize the collection and reporting of Rx/OTC medication use.
Conduct fitness-for-duty assessments.
Expand TSI post-accident procedures to address Rx/OTC.
Educate transit systems.
Educate physicians.

7. History
2011: RLS & Associates Convened Expert Panel to Review 2009 Survey Results.
Recommendations from Expert Panel:
Focus on safety and ensuring that safety-sensitive employees are medically-qualified.
Develop standard for retaining Rx/OTC medication information.
Educate safety-sensitive employees on meaning of fitness-for-duty.
Establish medical qualification standards for industry.

8. History Recommendations from Expert Panel:
Collect information before and after implementation to enable cost/benefit evaluation.
Study extent that Rx/OTC medication is a causal or contributing factor in transit accidents.
Research legal/liability issues of Rx/OTC policies
HIPAA
ADA
Labor Unions

9. Actions to Date Rx/OTC Toolkit issued April 2011
To download the FTA Rx/OTC Medication Toolkit,
go to:
Click on Drug and Alcohol Program.

10. Actions to Date
Advisory Group reviewed Draft Rx/OTC Medication Study and Recommendations April 2011
Final Study and Recommendations completed October 2011
Follow-up Post Accident Questionnaire initiated December 2011

11. General Guidance Recommendations
Encourage transit systems to test for additional substances under their own authority following accidents.
10-panel or more.
Expanded opiate testing.
Expanded benzodiazepine testing.
Methadone and other drugs should be considered.
In addition to DOT 5-panel drug test.
Incorporate Rx/OTC medications with common side effects that can impair driving into future Post Accident Testing Heuristics (PATH) studies

12. 2011-2012 Post Accident Questionnaire
277 Total Systems Contacted for Initial Online Questionnaire: 4,196 Accidents
These numbers were the total reported to NTD for 2010
Of the 277 systems initially contacted:
79 Systems responded – 1,820 Accidents
Of the 79 Respondents:
67 Systems collect Rx/OTC information – 1,692 Accidents
Of the 67 Systems that collect Rx/OTC information:
50 Systems provided follow-up data on selected accidents-1,202 Accidents
This Survey: 79 Respondents
Last Year’s Survey: 128 Respondents
This Survey: 343 accidents with reported data from systems
Last Year’s Survey: 243 accidents with reported data from systems
This Survey, as of Jan 26, 2012: Even with 40% less respondents in the pool, we were able to get data on 30% more accidents than last year’s survey; with a better spread across the various states.

13. Summary Of Responses Of the 1,202 possible accidents:
Data for 376 (~31%) out the total 1,202 accidents reported to NTD has been provided.
Large Urban
64%
This Survey: 79 Respondents
Last Year’s Survey: 128 Respondents
This Survey: 343 accidents with reported data from systems
Last Year’s Survey: 243 accidents with reported data from systems
This Survey, as of Jan 26, 2012: Even with 40% less respondents in the pool, we were able to get data on 30% more accidents than last year’s survey; with a better spread across the various states.
Small Urban
32%
Rural – 4%

14. Summary Of Responses

15. Summary Of Responses
Is it a standard practice for your system to ask about Rx/OTC information as a part of all Post-Accident investigations?

16. Summary Of Responses
Were any Rx/OTC medications discovered as part of the Post-Accident Investigation?
Yes – 4 Accidents (~8%)
No – 45 Accidents (~92%)
Were any Rx/OTC medications pre-disclosed, prior to the accident?
Yes – 17 Systems (34%) / 55 Accidents (~14%)
No – 33 Systems (66%) / 321 Accidents (~86%)
98 Unique Rx/OTC medications discovered from the 55 Accidents.

17. Reported Rx/OTC Summary
Of 376 accidents studied
146 instances of medication use reported
96 unique medications
54 Medications (56%) with potential side effects that may impair driving
Dizziness/lightheadedness (30)
Drowsiness/fatigue (19)
Impair Judgment (3)
Cause anxiety/insomnia (2)

18. Reported Rx/OTC Summary
20% (28) were antihypertensive medications (commonly prescribed for high blood pressure)
40% were Rx pain relievers (12)
Sedative/hypnotics (2)
Muscle relaxers (6)
One report of Chantix for smoking cessation

19. Trends & Other Information
Most systems (85%) that responded to the questionnaire are collecting Rx/OTC medication information:
Very few are integrating the Rx/OTC information with Post-Accident investigations.
After collecting Rx/OTC information from the employee, nothing is done with that information.
After an employee reports Rx/OTC medication use, systems do not track how long the employee is expected to take the medication(s).

20. Trends & Other Information
The most common response from systems when asked why they do not inquire about Rx/OTC information as a part of Post-Accident investigations was fear/uncertainty of violating HIPAA.
Many systems only ask employees about Rx/OTC medication use as a part of initial physicals, annual physicals, and bi-annual physicals.

21. List of Reported Medications
Bold = Name of Medication as Reported by the Transit System
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 1
Accupril – (1)
quinapril
antihypertensive Rx
hypertension (high blood pressure)
dizziness, lightheadedness 2
Advair – (1)
fluticasone/salmeterol
bronchodilator/steroid
asthma; COPD
dizziness 3
Advil – (2)
ibuprofen
pain reliever
OTC
n/a 4
Aleve – (2)
naprosyn
 pain reliever 5
Zyloprim
Allopurinol - (2)
treatment of gout
gout 6
Ambien – (1)
zolpidem
sedative/hypnotic
Insomnia
drowsiness, fatigue 7
Norvasc
Amilodipine – (3)
hypertension (high blood pressure), control angina 8
Lotrel
amlodipine/benazepril – (1)
hypertension 9
Amoxil – (1)
amoxicillin
antibiotic 10
ASA - (3)
aspirin 11
Tenormin
Atenolol – (1)
hypertension (high blood pressure); control angina
dizziness; lightheadedness 12
Avandamet – (1)
rosiglitazone/metformin
antidiabetic
 hyperglycemia
lightheadedness; hypoglycemia

22. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 13
Avapro – (1)
irbrsartan
antihypertensive Rx
hypertension (high blood pressure)
dizziness; lightheadedness 14
Benadryl – (1)
diphenhydramine
antihistamine; sedative/hypnotic
OTC
allergies; insomnia
drowsiness; fatigue 15
Lotensin
benazepril – (1)
 antihypertensive
dizziness, lightheadedness 16
BuSpar
buspirone – (1)
antianxiety
drowsiness; dizziness 17
Celebrex – (2)
celcoxib
pain reliever, nonsteroidal anti-inflammatory
n/a 18
Chantix – (1)
varenicline
smoking cessation
fatigue 19
Claritin – (1)
loratadine
antihistamine 20
Klonopin
clonazepam – (1)
drowsiness 21
colchicine – (2)
treatment of gout
gout 22
Coreg – (1)
carvedilol
 hypertension (high blood pressure)
dizziness, fatigue 23
Coumadin – (1)
warfarin
anticoagulant
prevent blood clots  24
Crestor – (1)
rosuvastatin
antihyperlipidemic
 lowers cholesterol 25
Detrol – (1)
tolterodine
anticholinergic
incontinence
dizziness 26
Lanoxin
digoxin – (1)
congestive heart failure
 Rx
 congestive heart failure

23. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 27
Diovan – (3)
valsartan
antihypertensive Rx
hypertension (high blood pressure)
dizziness, fatigue 28
Dispositron – (1)
unable to identify
 unable to identify 29
Sinequan
doxepin – (1)
antidepressant; antianxiety
depression, anxiety
drowsiness 30
(drocode) dihydrocodeine – (1)
pain reliever, moderate to severe
 Rx 31
venlafaxine
Effexor – (1)
antidepressant
depression
dizziness 32
Vasotec
enalapril – (1) 33
Plendil
felodipine – (1)
 antihypertensive
 hypertension (high blood pressure)
 dizziness, fatigue 34
Propecia; Proscar
finasteride – (1)
androgen hormone inhibitor
 enlarged prostate; male pattern hair loss
dizziness; hypotension 35
Flexeril – (3)
cyclobenzaprine
skeletal muscle relaxant
 muscle spasm
drowsiness; fatigue 36
Flonase – (1)
fluticasone
steroid
intranasal steroid
n/a 37
Flovent – (1)
asthma 38
Glucotrol
glipizide – (1)
antidiabetic
hyperglycemia (Diabetes)
lightheadedness; hypoglycemia 39
glucosamine – (1)
OTC nutritional supplement
 OTC

24. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 40
estradiol
Gynodiol – (1)
estrogen
 Rx
 estrogen replacement
n/a 41
Hydrodiuril
hydrochlorothiazide – (5)
antihypertensive Rx
hypertension (high blood pressure)
dizziness, lightheadedness 42
Vicodin; Lortab; Lorcet
hydrocodone with acetaminophen – (1)
pain reliever, moderate to severe
 pain reliever, moderate to severe
drowsiness 43
Motrin; Aleve
ibuprofen – (3)
pain reliever
Rx or OTC 44
dutasteride/tamsulosin
Jalyn – (1)
hormone
prostate enlargement 45
Lasix – (1)
furosemide
 diuretic 46
Levemir – (1)
insulin
antidiabetic
hyperglycemia
lightheadedness; hypoglycemia 47
Synthroid
levothyroxine – (1)
hypothyroidism 48
Lexapro – (1)
escitalopram
selective serotonin reuptake inhibitor (SSRI)
antidepressant
impair judgment, thinking, or motor skills 49
Lidex – (1)
fluocinonide
topical steroid
topical steroid  50
Lipitor – (1)
Atorvastatin
antihyperlipidemic
lower cholesterol 51
Prinivil
lisinopril – (7) 52
Claritin
loratadine – (1)
antihistamine
OTC
Allergy symptoms

25. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 53
Lortab – (2)
hydrocodone with acetaminophen
pain reliever, moderate to severe Rx
drowsiness 54
Lotrel – (2)
amlodipine/benazepril
antihypertensive
hypertension (high blood pressure)
dizziness, lightheadedness 55
Lyrica – (1)
pregabalin
anticonvulsant
pain reliever, neuropathic
dizziness 56
Medrol – (1)
methylprednisolone
steroid
 inflammation
n/a 57
Glucophage
metformin – (3)
antidiabetic
hyperglycemia
lightheadedness, hypoglycemia 58
Lopressor
metoprolol – (1) 59
Motrin – (5)
Ibuprofen
pain reliever
 Rx 60
Naprosyn – (2)
Naproxen – (2)
Pain reliever
 pain reliever 61
Nifediac – (1)
nifedipine
 antihypertensive
 hypertension (high blood pressure)
 dizziness, lightheadedness 62
nitroglycerin – (1)
vasodilator
 treat angina 63
Norvasc – (1)
amilodipine
hypertension (high blood pressure), control angina 64
omega-3 fatty acids – (1)
nutritional supplement
OTC
nutritional supplement. 65
Prilosec – (3)
omeprazole – (2)
gastroesophageal reflux disease (GERD)
Rx or OTC
 gastroesophageal reflux disease (GERD)

26. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 66
Paxil – (1)
paroxetine
selective serotonin reuptake inhibitor (SSRI) Rx
antidepressant
impair judgment, thinking, or motor skills 67
n/a
pectin – (1)
OTC nutritional supplement
 OTC 68
Percocet – (2)
oxycodone with acetaminophen
pain reliever, moderate to severe
drowsiness 69
Plavix – (2)
clopidogrel
antiplatelet
stroke prevention 70
Prevacid – (2)
lansoprazole
gastroesophageal reflux disease (GERD)
Rx or OTC 71
Proventil – (1)
albuterol
bronchodilator
nervousness 72
Provigil – (1)
modafinil
stimulant
narcolepsy
anxiety, insomnia 73
Accupril
quinapril – (1)
antihypertensive
hypertension (high blood pressure)
dizziness, lightheadedness 74
Zantac
ranitidine – (1) 75
Rhinocort – (1)
budesonide
steroids
Allergy symptoms 76
Zocor
simvastatin – (3)
antihyperlipidemic
Lower cholesterol 77
Januvia
sitagliptin – (1)
antidiabetic
 hyperglycemia
lightheadedness; hypoglycemia 78
Soma – (1)
carisoprodol
muscle relaxant
 muscle relaxant

27. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 79
Synthroid – (1)
levothyroxine
hypothyroidism Rx
n/a 80
Restoril
temazepam – (1)
sedative/hypnotic
Insomnia
drowsiness, fatigue 81
Synthroid
(levo)thyroxine – (1)
Thyroid Hormone
Hypothyroidism 82
Zanaflex
tizanidine – (1)
skeletal muscle relaxant
muscle spasm
dizziness 83
Toprol – (1)
metoprolol
antihypertensive
hypertension (high blood pressure); control angina
drowsiness; dizziness; blurred vision 84
Ultram
tramadol – (1)
pain reliever, moderate to severe
 Rx
 pain reliever, moderate to severe
drowsiness 85
Oeptro
trazodone – (3)
Antidepressant
depressant 86
Tylenol with Codeine #3 – (2)
acetaminophen with codeine #3 87
Unidentified diabetic medication – (1)
unable to identify
 unable to identify 88
Unidentified high blood pressure medication – (1) 89
Viagra – (1)
sildenafil
erectile dysfunction 90
Vicodin – (3)
hydrocodone with acetaminophen 91
Victoza – (1)
liraglutide
antidiabetic
 hyperglycemia
lightheadedness; hypoglycemia

28. List of Reported Medications
Medications Reported
Trade Name
Generic name
Medication Type
Rx or OTC
Common Indications
Common Side Effects Which May Impair Driving 92
Wellbutrin – (2)
bupropion
antidepressant Rx
agitation, anxiety, insomnia 93
Xanax – (2)
alprazolam
benzodiazepine
antianxiety
drowsiness, dizziness 94
Zantac – (1)
ranitidine
gastroesophageal reflux disease (GERD)
n/a 95
Zegerid – (1)
omeprazole 96
Zoloft – (1)
sertraline
selective serotonin reuptake inhibitor (SSRI)
impair judgment, thinking, or motor skills

29. Indiana Medical Qualification Program

30. Overview
In 2011, the Indiana DOT mandated a Medical Qualification (MQ) Program for all of its 45 Section 5311 Grantees. The MQ Program includes:
A comprehensive MQ Policy
Physical and Cognitive medical assessments for all safety sensitive employees
Rx/OTC Medication Policy

31. Indiana Medical Qualification Program
Indiana Council on Specialized Transportation (INCOST) conducted a procurement for a vendor to perform medical qualification assessments and other services under the oversight of a Medical Determination Officer

32. Indiana Medical Qualification Program, cont’d
Each Section 5311 system has entered into a contract with the selected vendor
Medical Assessments are underway

33. Indiana Medical Qualification Program, cont’d
Assessments Completed September 1, 2011 through January 20, 2012
New Hires
Annual
Return to Active Status
Supervisor Observation Concern 1
Post Accident
Actual Pre employment test performed were 95 – information entered for only 93
Annual physicals performed through January 20th is 562 but information has only been entered for 404
Total all tests performed through January 20th is 659
Total tests for Indiana Safety Sensitive positions is expected to exceed 1000 with over 936 of these tests annual assessments of existing employees.
95 pre-employment
562 annual
1 return to active status
1 Supervisor Observation Concern
0 Post Accident

34. Indiana Medical Qualification Program, cont’d
New Hire Results
89 granted one year qualification
2 were temporarily disqualified and referred for additional testing that resulted in qualifying status
2 were deemed unqualified

35. Indiana Medical Qualification Program, cont’d
Annual Assessment Results
337 granted one year qualification
19 granted three month qualification
1 granted six month qualification
114 were referred for additional testing
44 of the 114 were temporarily disqualified, however 35 of the 44 now meet MQ requirements
3 were deemed unqualified

36. Indiana Medical Qualification Program, cont’d
Referral Reasons
Blood Pressure
Vision
Hearing
Diabetes
Sleep Apnea
Physical Abilities
Cardiovascular

37. Indiana Medical Qualification Program, cont’d
Other Assessments
The Return to Active Status employee was granted qualification
The Supervisor Observation Concern employee was deemed unqualified

38. Indiana Medical Qualification Program, cont’d
Average number of prescription and over the counter medications reported
New Hires average number of medications = 1.78
Qualified for one year employees average number of medications =4.48
Qualified for six months employees average number of medications = 5.69
Qualified for three months employees average number of medications = 6.08

39. Indiana Medical Qualification Program, cont’d
The Indiana Medical Qualification Program Medical Assessment requires individuals to complete a Health Risk Assessment questionnaire. The results of the questionnaire are used as a tool for the Medical Determination Officer to evaluate the overall health of the individual and to provide the individual will wellness information if desired.

40. Indiana Medical Qualification Program, cont’d
The following slides contain a summary of the self reported Health Risk Assessment results from November 1, 2011 through January 20, 2011.

41. Assessment Participants

42. Participant Age
Average Age: 57.43

43. Self Identified Risks
Average # Risk Factors: 3.3

44. Self Health Rating

45. Top 8 Medical Conditions Reported

46. Top 8 Controllable Risk Factors

47. Participants’ Readiness for Change

48. Participant Health Visit History

49. Physician Visits Past 12 Months

50. Participant Hospital Admissions Past 12 Months

51. Participant Tobacco Substance Abuse

52. Participant Substance Abuse Alcohol

53. Participant Medication Use as Relaxation Aid

54. Participant Satisfaction with Life and Work

55. Participant Stress Level

56. Medical Determination Officer Comments
The Medical Determination Officer identified several conditions that are cause for concern for safety sensitive transit employees. The conditions causing concern in no particular order are:
Sleep Apnea
Cardiovascular Disease
Diabetes

57. Medical Determination Officer Comments, cont’d
Cerebrovascular Disease
Hypertension
Musculoskeletal Disorder
Cognitive Decline
Physical Agility Concerns
Medication Issues
Physician/Patient Relationship
Wellness and Self Care Issues

58. Indiana Medical Qualification Before and After Survey Results
Indiana’s 5311 transit systems were asked to complete a survey to determine the impact of implementing the Medical Qualification (MQ) Program.
The survey focused on safety-sensitive transit employees only.
The financial impact of implementing the MQ Program.
The impact implementing the MQ had on staffing and employee time off from safety-sensitive functions.
Management perspective of safety-sensitive employee wellness and safety.

59. Before and After Data
The survey captured data for the year prior to implementing the MQ Program (2010) and data the year the MQ Program was implemented (2011) to allow for implementation impact comparison.

60. Survey Participants
Indiana has 48 designees required to participate in the Indiana Medical Qualification Program.
42 designees had established MQ Programs at the time of the survey.
The designees safety-sensitive staff range in size from 3 employees to 150 employees.
Survey participants staff ranged in size from 3 safety-sensitive employees to 150 safety-sensitive employees.
24 designees completed the survey representing 57% of designees with established MQ Programs.