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FitnessforDuty

Prescription/Over‐the‐CounterMedicationUseand

MedicalQualification

RobbieL.SarlesRLS&Associates,Inc.

May31,2012

♦ 2002:NationalTransportationSafetyBoard(NTSB)challengetoallFTAgrantrecipients:○ ReviewRx/OTCPolicies.○ EducateoperatorsofpotentialrisksassociatedwithRx/OTCuse.

♦ 2003:FTAReleasedRx/OTCMedicationToolkit:○ “State‐Of‐The‐Practice”atthattime.

History

♦ NTSBSatisfiedbyResponses,but:○ FurtherresearchneededtoestablishnatureofrelationshipbetweenRx/OTCmedicationsandtransitaccidents.

History

♦ 2009:RLS&Associates,Inc.Conducted2Surveys:○ GaugeprogressonRx/OTCpolicies&procedures.

○ Inquireaboutaccidentinvestigationpractices.○ UpdatetheFTARx/OTCMedicationToolkit.

History

♦ SurveyRespondentsindicated:○ Rx/OTCpoliciesinplace,butwerelimitedinscopeandrarelyenforced.

○ MostwerenotcollectingRx/OTCmedicationinformation.

○ IfRx/OTCmedicationinformationwascollected,littlewasdonewithit.

○ Nocorrelationbetweenthatinformationandaccidentinvestigations.

History

♦ 2009Rx/OTCSurveyRecommendations:○ StandardizethecollectionandreportingofRx/OTCmedicationuse.

○ Conductfitness‐for‐dutyassessments.○ ExpandTSIpost‐accidentprocedurestoaddressRx/OTC.

○ Educatetransitsystems.○ Educatephysicians.

History

♦ 2011:RLS&AssociatesConvenedExpertPaneltoReview2009SurveyResults.

♦ RecommendationsfromExpertPanel:○ Focusonsafetyandensuringthatsafety‐sensitiveemployeesaremedically‐qualified.

○ DevelopstandardforretainingRx/OTCmedicationinformation.

○ Educatesafety‐sensitiveemployeesonmeaningoffitness‐for‐duty.

○ Establishmedicalqualificationstandardsforindustry.

History

♦ RecommendationsfromExpertPanel:○ Collectinformationbeforeandafterimplementationtoenablecost/benefitevaluation.

○ StudyextentthatRx/OTCmedicationisacausalorcontributingfactorintransitaccidents.

○ Researchlegal/liabilityissuesofRx/OTCpolicies HIPAA ADA LaborUnions

History

ActionstoDate

♦ Rx/OTCToolkitissuedApril2011

TodownloadtheFTARx/OTCMedicationToolkit,goto:

http://transit‐safety.fta.dot.gov/PublicationsClickonDrugandAlcoholProgram.

ActionstoDate

♦ AdvisoryGroupreviewedDraftRx/OTCMedicationStudyandRecommendationsApril2011

♦ FinalStudyandRecommendationscompletedOctober2011

♦ Follow‐upPostAccidentQuestionnaireinitiatedDecember2011

GeneralGuidanceRecommendations

♦ Encouragetransitsystemstotestforadditionalsubstancesundertheirownauthorityfollowingaccidents.○ 10‐panelormore.○ Expandedopiatetesting.○ Expandedbenzodiazepinetesting.○ Methadoneandotherdrugsshouldbeconsidered.○ InadditiontoDOT5‐paneldrugtest.

♦ IncorporateRx/OTCmedicationswithcommonsideeffectsthatcanimpairdrivingintofuturePostAccidentTestingHeuristics(PATH)studies

2011‐2012PostAccidentQuestionnaire

♦ 277TotalSystemsContactedforInitialOnlineQuestionnaire:4,196Accidents○ ThesenumberswerethetotalreportedtoNTDfor2010

♦ Ofthe277systemsinitiallycontacted:○ 79Systemsresponded– 1,820Accidents

♦ Ofthe79Respondents:○ 67SystemscollectRx/OTCinformation– 1,692Accidents

♦ Ofthe67SystemsthatcollectRx/OTCinformation:○ 50Systemsprovidedfollow‐updataonselectedaccidents‐1,202Accidents

376

TransitSystemSize

SummaryOfResponses♦ Ofthe1,202possibleaccidents:

○ Datafor376(~31%)outthetotal1,202accidentsreportedtoNTDhasbeenprovided.

SmallUrban32%

LargeUrban64%

Rural– 4%

SummaryOfResponses

1%

2%

3%

93%

0 50 100 150 200 250 300 350 400

NoCauseDocumented

Mechanical

HumanErrorPlusOtherFactors(weather)

HumanError

NumberOfAccidents

CauseOfAccident?

♦ IsitastandardpracticeforyoursystemtoaskaboutRx/OTCinformationasapartofallPost‐Accidentinvestigations?

SummaryOfResponses

♦ WereanyRx/OTCmedicationsdiscoveredaspartofthePost‐AccidentInvestigation?○ Yes– 4Accidents(~8%)○ No– 45Accidents(~92%)

♦ WereanyRx/OTCmedicationspre‐disclosed, priortotheaccident?○ Yes– 17Systems(34%)/55Accidents(~14%)○ No– 33Systems(66%)/321Accidents(~86%)○ 98UniqueRx/OTCmedicationsdiscoveredfromthe55Accidents.

SummaryOfResponses

♦ Of376accidentsstudied○ 146instancesofmedicationusereported○ 96uniquemedications

♦ 54Medications(56%)withpotentialsideeffectsthatmayimpairdriving○ Dizziness/lightheadedness(30)○ Drowsiness/fatigue(19)○ ImpairJudgment(3)○ Causeanxiety/insomnia(2)

ReportedRx/OTCSummary

♦ 20%(28)wereantihypertensivemedications(commonlyprescribedforhighbloodpressure)

♦ 40%wereRxpainrelievers(12)

♦ Sedative/hypnotics(2)

♦ Musclerelaxers(6)

♦ OnereportofChantixforsmokingcessation

ReportedRx/OTCSummary

Trends&OtherInformation

♦ Mostsystems(85%)thatrespondedtothequestionnairearecollectingRx/OTCmedicationinformation:○ VeryfewareintegratingtheRx/OTCinformationwithPost‐Accidentinvestigations.

○ AftercollectingRx/OTCinformationfromtheemployee,nothingisdonewiththatinformation.

○ AfteranemployeereportsRx/OTCmedicationuse,systemsdonottrackhowlongtheemployeeisexpectedtotakethemedication(s).

Trends&OtherInformation

♦ ThemostcommonresponsefromsystemswhenaskedwhytheydonotinquireaboutRx/OTCinformationasapartofPost‐Accidentinvestigationswasfear/uncertaintyofviolatingHIPAA.

♦ ManysystemsonlyaskemployeesaboutRx/OTCmedicationuseasapartofinitialphysicals,annualphysicals,andbi‐annualphysicals.

ListofReportedMedicationsYELLOW = Medication Also Cited in October, 2011 Report.

Medications ReportedTrade Name

Medications ReportedGeneric 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 Rx asthma; COPD dizziness

3

Advil – (2) ibuprofen pain reliever OTC pain reliever n/a

4

Aleve – (2) naprosyn pain reliever OTC pain reliever n/a

5

Zyloprim Allopurinol - (2) treatment of gout Rx gout n/a

6

Ambien – (1) zolpidem sedative/hypnotic Rx Insomnia drowsiness, fatigue

7

Norvasc Amilodipine – (3) antihypertensive Rx hypertension (high blood pressure), control angina

dizziness, lightheadedness

8

Lotrel amlodipine/benazepril – (1) antihypertensive Rx hypertension dizziness, lightheadedness

9

Amoxil – (1) amoxicillin antibiotic Rx antibiotic n/a

10

ASA - (3) aspirin pain reliever OTC pain reliever n/a

11

Tenormin Atenolol – (1) antihypertensive Rx hypertension(highbloodpressure);controlangina

dizziness;lightheadedness

12

Avandamet – (1) rosiglitazone/metformin antidiabetic Rx hyperglycemia lightheadedness; hypoglycemia

Bold = Name of Medication as Reported by the Transit System

ListofReportedMedications

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 Rx hypertension (high blood pressure)

dizziness, lightheadedness

16

BuSpar buspirone – (1) antianxiety Rx antianxiety drowsiness; dizziness

17

Celebrex – (2) celcoxib pain reliever, nonsteroidal anti-inflammatory

Rx pain reliever, nonsteroidal anti-inflammatory

n/a

18

Chantix – (1) varenicline smoking cessation Rx smoking cessation fatigue

19

Claritin – (1) loratadine antihistamine OTC antihistamine n/a

20

Klonopin clonazepam – (1) antianxiety Rx antianxiety drowsiness

21

n/a colchicine – (2) treatment of gout Rx gout n/a

22

Coreg – (1) carvedilol antihypertensive Rx hypertension (high blood pressure)

dizziness, fatigue

23

Coumadin – (1) warfarin anticoagulant Rx prevent blood clots n/a

24

Crestor – (1) rosuvastatin antihyperlipidemic Rx lowers cholesterol n/a

25

Detrol – (1) tolterodine anticholinergic Rx incontinence dizziness

26

Lanoxin digoxin – (1) congestive heart failure Rx congestive heart failure n/a

Medications ReportedTrade Name

Medications ReportedGeneric name

Medication Type Rx or OTC

Common Indications Common Side Effects Which May Impair Driving

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric 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 unable to identify unable to identify

29

Sinequan doxepin – (1) antidepressant; antianxiety Rx depression, anxiety drowsiness

30

(drocode) dihydrocodeine – (1)

pain reliever, moderate to severe

Rx pain reliever, moderate to severe

drowsiness

31

venlafaxine Effexor – (1) antidepressant Rx depression dizziness

32

Vasotec enalapril – (1) antihypertensive Rx hypertension (high blood pressure)

dizziness, fatigue

33

Plendil felodipine – (1) antihypertensive Rx hypertension (high blood pressure)

dizziness, fatigue

34

Propecia; Proscar finasteride – (1) androgen hormone inhibitor Rx enlarged prostate; male pattern hair loss

dizziness; hypotension

35

Flexeril – (3) cyclobenzaprine skeletal muscle relaxant Rx muscle spasm drowsiness; fatigue

36

Flonase – (1) fluticasone steroid Rx intranasal steroid n/a

37

Flovent – (1) fluticasone steroid Rx asthma n/a

38

Glucotrol glipizide – (1) antidiabetic Rx hyperglycemia(Diabetes) lightheadedness;hypoglycemia

39

n/a glucosamine – (1) OTC nutritional supplement OTC OTC nutritional supplement n/a

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric 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

Rx pain reliever, moderate to severe

drowsiness

43

Motrin; Aleve ibuprofen – (3) pain reliever Rx or OTC

pain reliever n/a

44

dutasteride/tamsulosin Jalyn – (1) hormone Rx prostate enlargement n/a

45

Lasix – (1) furosemide diuretic Rx hypertension (high blood pressure)

n/a

46

Levemir – (1) insulin antidiabetic Rx hyperglycemia lightheadedness; hypoglycemia

47

Synthroid levothyroxine – (1) hypothyroidism Rx hypothyroidism n/a

48

Lexapro – (1) escitalopram selective serotonin reuptake inhibitor (SSRI)

Rx antidepressant impair judgment, thinking, or motor skills

49

Lidex – (1) fluocinonide topical steroid Rx topical steroid n/a

50

Lipitor – (1) Atorvastatin antihyperlipidemic Rx lower cholesterol n/a

51

Prinivil lisinopril – (7) antihypertensive Rx hypertension (high blood pressure)

dizziness, lightheadedness

52

Claritin loratadine – (1) antihistamine OTC Allergysymptoms n/a

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric 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 pain reliever, moderate to severe

drowsiness

54

Lotrel – (2) amlodipine/benazepril antihypertensive Rx hypertension (high blood pressure)

dizziness, lightheadedness

55

Lyrica – (1) pregabalin anticonvulsant Rx pain reliever, neuropathic dizziness

56

Medrol – (1) methylprednisolone steroid Rx inflammation n/a

57

Glucophage metformin – (3) antidiabetic Rx hyperglycemia lightheadedness, hypoglycemia

58

Lopressor metoprolol – (1) antihypertensive Rx hypertension (high blood pressure)

dizziness, lightheadedness

59

Motrin – (5) Ibuprofen pain reliever Rx pain reliever n/a

60

Naprosyn – (2) Naproxen – (2) Pain reliever Rx pain reliever n/a

61

Nifediac – (1) nifedipine antihypertensive Rx hypertension (high blood pressure)

dizziness, lightheadedness

62

n/a nitroglycerin – (1) vasodilator Rx treat angina dizziness

63

Norvasc – (1) amilodipine antihypertensive Rx hypertension (high blood pressure), control angina

dizziness, lightheadedness

64

n/a omega-3 fatty acids – (1) nutritional supplement OTC nutritional supplement. n/a

65

Prilosec – (3) omeprazole – (2) gastroesophageal reflux disease (GERD)

Rx or OTC

gastroesophageal reflux disease (GERD)

n/a

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric 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 OTC nutritional supplement n/a

68

Percocet – (2) oxycodone with acetaminophen

pain reliever, moderate to severe

Rx pain reliever, moderate to severe

drowsiness

69

Plavix – (2) clopidogrel antiplatelet Rx stroke prevention n/a

70

Prevacid – (2) lansoprazole gastroesophageal reflux disease (GERD)

Rx or OTC

gastroesophageal reflux disease (GERD)

n/a

71

Proventil – (1) albuterol bronchodilator Rx bronchodilator nervousness

72

Provigil – (1) modafinil stimulant Rx narcolepsy anxiety, insomnia

73

Accupril quinapril – (1) antihypertensive Rx hypertension (high blood pressure)

dizziness, lightheadedness

74

Zantac ranitidine – (1) gastroesophageal reflux disease (GERD)

Rx gastroesophageal reflux disease (GERD)

n/a

75

Rhinocort – (1) budesonide steroids Rx Allergy symptoms n/a

76

Zocor simvastatin – (3) antihyperlipidemic Rx Lower cholesterol n/a

77

Januvia sitagliptin – (1) antidiabetic Rx hyperglycemia lightheadedness; hypoglycemia

78

Soma – (1) carisoprodol muscle relaxant Rx muscle relaxant drowsiness

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric name

Medication Type Rx or OTC

Common Indications Common Side Effects Which May Impair Driving

79

Synthroid – (1) levothyroxine hypothyroidism Rx hypothyroidism n/a

80

Restoril temazepam – (1) sedative/hypnotic Rx Insomnia drowsiness, fatigue

81

Synthroid (levo)thyroxine – (1) Thyroid Hormone Rx Hypothyroidism n/a

82

Zanaflex tizanidine – (1) skeletal muscle relaxant Rx muscle spasm dizziness

83

Toprol – (1) metoprolol antihypertensive Rx hypertension(highbloodpressure);controlangina

drowsiness;dizziness;blurredvision

84

Ultram tramadol – (1) pain reliever, moderate to severe

Rx pain reliever, moderate to severe

drowsiness

85

Oeptro trazodone – (3) Antidepressant Rx depressant drowsiness

86

Tylenol with Codeine #3 – (2) acetaminophen with codeine #3

pain reliever, moderate to severe

Rx pain reliever, moderate to severe

drowsiness

87

Unidentified diabetic medication – (1)

unable to identify unable to identify unable to identify unable to identify

88

Unidentified high blood pressure medication – (1)

unable to identify unable to identify unable to identify unable to identify

89

Viagra – (1) sildenafil erectile dysfunction Rx erectile dysfunction n/a

90

Vicodin – (3) hydrocodone with acetaminophen

pain reliever, moderate to severe

Rx pain reliever, moderate to severe

drowsiness

91

Victoza – (1) liraglutide antidiabetic Rx hyperglycemia lightheadedness; hypoglycemia

ListofReportedMedicationsMedications ReportedTrade Name

Medications ReportedGeneric name

Medication Type Rx or OTC

Common Indications Common Side Effects Which May Impair Driving

92

Wellbutrin – (2) bupropion antidepressant Rx antidepressant agitation, anxiety, insomnia

93

Xanax – (2) alprazolam benzodiazepine Rx antianxiety drowsiness, dizziness

94

Zantac – (1) ranitidine gastroesophageal reflux disease (GERD)

Rx gastroesophageal reflux disease (GERD)

n/a

95

Zegerid – (1) omeprazole gastroesophageal reflux disease (GERD)

Rx gastroesophageal reflux disease (GERD)

n/a

96

Zoloft – (1) sertraline selective serotonin reuptake inhibitor (SSRI)

Rx antidepressant impair judgment, thinking, or motor skills

IndianaMedicalQualificationProgram

Overview

♦ In2011,theIndianaDOTmandatedaMedicalQualification(MQ)Programforallofits45Section5311Grantees.TheMQProgramincludes:○ AcomprehensiveMQPolicy○ PhysicalandCognitivemedicalassessmentsforallsafetysensitiveemployees

○ Rx/OTCMedicationPolicy

IndianaMedicalQualificationProgram

♦ IndianaCouncilonSpecializedTransportation(INCOST)conductedaprocurementforavendortoperformmedicalqualificationassessmentsandotherservicesundertheoversightofaMedicalDeterminationOfficer

IndianaMedicalQualificationProgram,cont’d

♦ EachSection5311systemhasenteredintoacontractwiththeselectedvendor

♦ MedicalAssessmentsareunderway

IndianaMedicalQualificationProgram,cont’d

♦ AssessmentsCompletedSeptember1,2011throughJanuary20,2012○ NewHires 93○ Annual 404○ ReturntoActiveStatus 1○ SupervisorObservationConcern 1○ PostAccident 0

IndianaMedicalQualificationProgram,cont’d

♦ NewHireResults○ 89grantedoneyearqualification○ 2weretemporarilydisqualifiedandreferredforadditionaltestingthatresultedinqualifyingstatus

○ 2weredeemedunqualified

IndianaMedicalQualificationProgram,cont’d

♦ AnnualAssessmentResults○ 337grantedoneyearqualification○ 19grantedthreemonthqualification○ 1grantedsixmonthqualification○ 114werereferredforadditionaltesting○ 44ofthe114weretemporarilydisqualified,however35ofthe44nowmeetMQrequirements

○ 3weredeemedunqualified

IndianaMedicalQualificationProgram,cont’d

♦ ReferralReasons○ BloodPressure 46○ Vision 23○ Hearing 19○ Diabetes 11○ SleepApnea 9○ PhysicalAbilities 4○ Cardiovascular 2

IndianaMedicalQualificationProgram,cont’d

♦ OtherAssessments○ TheReturntoActiveStatusemployeewasgrantedqualification

○ TheSupervisorObservationConcernemployeewasdeemedunqualified

IndianaMedicalQualificationProgram,cont’d

♦ Averagenumberofprescriptionandoverthecountermedicationsreported○ NewHiresaveragenumberofmedications=1.78

○ Qualifiedforoneyearemployeesaveragenumberofmedications=4.48

○ Qualifiedforsixmonthsemployeesaveragenumberofmedications=5.69

○ Qualifiedforthreemonthsemployeesaveragenumberofmedications=6.08

IndianaMedicalQualificationProgram,cont’d

♦ TheIndianaMedicalQualificationProgramMedicalAssessmentrequiresindividualstocompleteaHealthRiskAssessmentquestionnaire.TheresultsofthequestionnaireareusedasatoolfortheMedicalDeterminationOfficertoevaluatetheoverallhealthoftheindividualandtoprovidetheindividualwillwellnessinformationifdesired.

IndianaMedicalQualificationProgram,cont’d

♦ ThefollowingslidescontainasummaryoftheselfreportedHealthRiskAssessmentresultsfromNovember1,2011throughJanuary20,2011.

AssessmentParticipants

AverageAge:57.43

ParticipantAge

Average#RiskFactors:3.3

SelfIdentifiedRisks

SelfHealthRating

Top8MedicalConditionsReported

Top8ControllableRiskFactors

Participants’ReadinessforChange

ParticipantHealthVisitHistory

PhysicianVisitsPast12Months

ParticipantHospitalAdmissionsPast12Months

ParticipantTobaccoSubstanceAbuse

ParticipantSubstanceAbuseAlcohol

ParticipantMedicationUseasRelaxationAid

ParticipantSatisfactionwithLifeandWork

ParticipantStressLevel

MedicalDeterminationOfficerComments

♦ TheMedicalDeterminationOfficeridentifiedseveralconditionsthatarecauseforconcernforsafetysensitivetransitemployees.Theconditionscausingconcerninnoparticularorderare:○ SleepApnea○ CardiovascularDisease○ Diabetes

MedicalDeterminationOfficerComments,cont’d

○ CerebrovascularDisease○ Hypertension○ MusculoskeletalDisorder○ CognitiveDecline○ PhysicalAgilityConcerns○ MedicationIssues○ Physician/PatientRelationship○ WellnessandSelfCareIssues

IndianaMedicalQualificationBeforeandAfterSurveyResults

Indiana’s5311transitsystemswereaskedtocompleteasurveytodeterminetheimpactofimplementingtheMedicalQualification(MQ)Program.

– Thesurveyfocusedonsafety‐sensitivetransitemployeesonly.• ThefinancialimpactofimplementingtheMQProgram.• TheimpactimplementingtheMQhadonstaffingandemployeetimeofffromsafety‐sensitivefunctions.

• Managementperspectiveofsafety‐sensitiveemployeewellnessandsafety.

BeforeandAfterData

ThesurveycaptureddatafortheyearpriortoimplementingtheMQProgram(2010)anddatatheyeartheMQProgramwasimplemented(2011)toallowforimplementationimpactcomparison.

SurveyParticipantsIndianahas48designeesrequiredtoparticipateintheIndianaMedicalQualificationProgram. 42designeeshadestablishedMQProgramsatthetimeofthesurvey.

Thedesigneessafety‐sensitivestaffrangeinsizefrom3employeesto150employees. Surveyparticipantsstaffrangedinsizefrom3safety‐sensitiveemployeesto150safety‐sensitiveemployees.

24designeescompletedthesurveyrepresenting57%ofdesigneeswithestablishedMQPrograms.

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