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Acoem Practice Guidelines 2nd Edition 2004 Chapter 11

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INTRODUCTION

Driving simulator and experimental studies suggest that acute opioid exposures are associated with driving-related impairments,1–3 with self-reported adverse effects markedly declining over days to weeks after initiation of an ongoing opioid prescription.4 , 5 However, most of the driving simulator and experimental studies that looked at chronic opioid exposures reported no indirect evidence of increased risk of crash.6–18 Other evidence suggests cognitive compromise among those with chronic opioid use, especially decision-making.19–21 It has been theorized that chronic pain itself causes cognitive decline, thus potentially confounding opioid use. However, the evidence does not appear to support this theory.22–26 Many researchers who have reviewed the literature have concluded there is no increased risk of motor vehicle crash with chronic opioid use.7 , 27–31

In response to the rise in opioids use, the American College of Occupational and Environmental Medicine (ACOEM) updated its opioid guidelines from the third edition of the ACOEM Practice Guidelines. This report summarizes the safety-sensitive recommendation developed for this update. The ACOEM Opioids Guideline is designed to provide health care providers, who are the primary target users, with evidence-based guidance for the use of opioids in treating working-age adults who have acute, subacute, chronic, or post-operative pain.

A 2009 guideline statement of the American Pain Society/American Academy of Pain Medicine on driving and work safety states that: "Clinicians should counsel patients on chronic opioid therapy about transient or lasting cognitive impairment that may affect driving and work safety. Patients should be counseled not to drive or engage in potentially dangerous activities when impaired or if they describe or demonstrate signs of impairment."32 It also states that: "In the absence of signs or symptoms of impairment, there is no evidence that patients maintained on stable doses of COT (chronic opioid therapy) should be restricted from driving."32 However, that guideline is now several years old and provides no references for original epidemiological studies, instead identifying two supportive review articles from one author27 , 28 plus some of the experimental studies.

In contrast, there are long-standing recommendations against the use of narcotics, particularly including opioids in safety-sensitive work such as in the transportation sector.33–35 Thus, whether opioids impair safety-sensitive work is unclear and prior evidence-based guidance is weak.

METHODS

A detailed methodology document used for development of this guideline (including evidence selection, scoring, incorporation of cost considerations,36 and formulation of recommendations) is available on the Internet37 and summarized elsewhere.38 , 39 Noteworthy additions pertaining to this guideline are inclusion of large epidemiological studies for evidence of harms used for guidance and a change in the databases searched. All evidence related to opioids in prior ACOEM Practice Guidelines 40–48 after searching seven databases was included in this guideline (Medline, EBM Online, Cochrane, TRIP, CINAHL, EMBASE, PEDro). Comprehensive searches for epidemiological evidence were performed with both Pubmed and Google Scholar up through October 2013 to help assure complete capture. There was no limit on year of publication. All identified studies were scored for quality.

Guidance was then drafted using a table of evidence that abstracted the epidemiological evidence. Draft text and tables were forwarded to the multi-disciplinary Evidence-based Practice Opioids Panel which reviewed the evidence and finalized the text and recommendations. This guideline achieved 100% Panel agreement.

Guidance is developed with sufficient detail to facilitate assessment of compliance (Institute of Medicine (IOM)) and auditing/monitoring (Appraisal of Guidelines for Research and Evaluation [AGREE]).36 , 49 Alternative options to manage conditions are provided in other ACOEM guidelines when comparative trials are available; however, alternative management strategies are provided in greater detail in other guidelines.40–48

The only AGREE36 and IOM criterion not adhered to is incorporation of the views of the target population. Patients taking opioids, those in therapy or recovered from opioid dependence or addiction, or other affected patient groups were not involved on the Panel or external review process, nor were advocates for or against use of opioids. In accordance with the IOM's Trustworthy Guidelines, this guideline underwent external peer review and detailed records are kept, including responses to external peer reviewers.49

While the primary patient population target is working adults, it is recognized that the principles may apply more broadly. The Evidence-based Practice Opioids Panel and the Research Team have complete editorial independence from the American College of Occupational and Environmental Medicine and Reed Group, neither of which has influenced the Guideline. The literature is routinely monitored and formally searched at least annually for evidence that would overturn this guidance. This guideline is planned to be updated at least every three years or more frequently should evidence require it.

This report summarizes the key findings for safety-sensitive work associated with use of opioids in ACOEM's Practice Guidelines.50 All treatment recommendations are guidance-based on synthesis of the evidence plus expert consensus. These are recommendations for practitioners and decisions to adopt a particular course of action must be made by trained practitioners on the basis of available resources and the particular circumstances presented by the individual patient.

RESULTS

The search strategies identified 21,478 article abstracts (176 PubMed, 1552 EBSCO, 19,750 Google Scholar) of epidemiological studies. All articles were evaluated and 12 were included in these analyses (Table 1).51–62 No epidemiological studies were identified addressing forklift driving, overhead crane operation, heavy equipment operation, cognitive function, and judgment. Disclosed conflicts of interest appear negligible among the authors of these studies (Table 1).

TABLE 1-a
TABLE 1-a:

Included Epidemiological Studies of Motor Vehicle Crash Risk among Opioid-using Drivers

TABLE 1-b
TABLE 1-b:

Included Epidemiological Studies of Motor Vehicle Crash Risk among Opioid-using Drivers

TABLE 1-c
TABLE 1-c:

Included Epidemiological Studies of Motor Vehicle Crash Risk among Opioid-using Drivers

TABLE 1-d
TABLE 1-d:

Included Epidemiological Studies of Motor Vehicle Crash Risk among Opioid-using Drivers

The identified studies included four population-based studies.51–53 , 55 These studies utilized databases for prescriptions and crashes. The largest included two studies including over 3.1 million people in Norway51 , 53 and 549,000 in Ontario, Canada.55 One study was limited to codeine and tramadol,51 one addressed risk from natural opium alkaloids,53 one aggregated opioid types,53 , 55 and one study focused on 4,626 methadone maintenance program participants.52 All of these population-based studies found elevated risks of crash associated with opioid use (Fig. 1 and Table 1). Sub-analyses for tramadol also appear positive but underpowered (Standardized Incidence Ratio 1.5; 95% CI: 0.9–2.3).51 Three studies were not included in Figure 1 as the risk estimates were comparisons with low dose opioid use rather than no use,55–57 thus likely underestimating the risk estimates of any opioid use. Dose response relationships are suggested from both of the two studies evaluating those potential relationships.51 , 55

FIGURE 1
FIGURE 1:

Risk Estimates and Confidence Intervals of Included Studies Assessing Relationships Between Opioid Use and Crashes.

There were three case-crossover studies,54 , 56 , 57 including one from the United Kingdom with 49,821 patients.54 One study found increased risk with acute opioid use (0–4 weeks), continued increased risk throughout the opioid treatment period, and reversal of the elevated risks on opioid cessation.54 One study suggesting increased risks did not clearly separate licit from illicit use.57

There were four case-control58 , 59 , 61 , 62 and one cross sectional studies.60 All reported an elevated risk of crash, except for a small case-control study (n = 8 cases, n = 20 controls) that reported an odds ratio for crash associated with opioids of 2.3 (95% C.I.0.87–6.32)61 and thus appears underpowered. One case-control study found elevated crash risk from use of buprenorphine and methadone.58 An elevated risk of fatal crash associated with opioids was reported from the USA's Fatality Analysis Reporting System of 75,026 drivers.59 The latter study also found an association with unsafe driving actions (especially failure to stay in the lane) that preceded fatal crashes.59

Based on the available evidence, the following recommendation is developed by the Evidence-based Practice Opioids Panel:

Acute or chronic opioid use is not recommended for patients who perform safety-sensitive jobs. These jobs include operating motor vehicles, other modes of transportation, forklift driving, overhead crane operation, heavy equipment operation, sharps work (eg, knives, box cutters, needles), work with injury risks (eg, heights) and tasks involving high levels of cognitive function and judgment. The rating level is "C." Confidence in the recommendation is moderate. Panel agreement with this guideline recommendation is 100%.

Among those treated with opioids, including tramadol, sufficient time after the last dose is recommended to eliminate approximately 90% of the drug and active metabolites from their system. Caution is also warranted for those consuming other depressant medications such as benzodiazepines and sedating antihistamines. Provider and organizational barriers to implement this recommendation are relatively few. However, there may be some patients taking opioids while employed in safety-sensitive jobs, and there are no validated tools to assess whether they can perform their job safely.

Benefits of this guideline include potential reductions in accidents and injury risks to self, public and coworkers. Potential harms of this guideline may include preclusion of someone from working who is theoretically not at increased risk, although there is no validated method to demonstrate an individual's safety while consuming opioids.

DISCUSSION

Acute or chronic opioid use is not recommended for patients who perform safety-sensitive jobs. By analogy, this recommendation is extended beyond operation of motor vehicles to include other modes of transportation, forklift driving, overhead crane operation, heavy equipment operation, work with sharps, work with risk of injury (eg, heights) and tasks involving high levels of cognitive function.19–21 , 22–26

Both weak and strong opioids have been consistently associated with increased risk of motor vehicle crashes (MVC) in all large epidemiological studies of working age adults sufficiently powered to detect motor vehicle crash risk with the risk estimates ranging from 29% to more than 800% increased risk.51–56 , 58–60 There also is some evidence suggestive of a dose-response relationship.51 , 55

Strengths of this guideline include a relatively large database of studies. This evidence also includes consistent findings involving large populations, different study designs and different countries. Only one study did not find statistical significance of increased risk,61 yet has a small sample size with a point estimate suggesting increased risk that appears underpowered. Therefore, the overall evidence base is strongly supportive of this guideline's recommendation. The "C" rating instead of a higher rating is due to the reliance on epidemiological studies rather than randomized controlled trials.

Weaknesses of this guideline include the theoretical possibility that there are patients without increased risk. Presumably if such exist, they are on very low doses of opioids. Yet, this guideline did not find either absence of, or lower risk among those on either lower doses or weaker opioids, suggesting if there is a threshold for no increased risk, that threshold is apparently at a very low morphine equivalent dosage. Further epidemiological research investigating those possibilities may be helpful. However, in summary, the ACOEM Evidence-based Practice Opioids Panel recommends preclusion of opioid use in safety-sensitive jobs.

Acknowledgements

The Evidence-based Practice Opioids Panel recognizes the considerable work of the managing editors: Marianne Dreger, MA (Production) and Julie A. Ording, MPH (Research). The Opioids Panel also much appreciates the research for this guideline that was conducted by the research team: Ulrike Ott, PhDc, MSPH; Atim C. Effiong, MPH; Deborah G. Passey, MS; William G. Caughey, MS; Holly Uphold, PhD; Alzina Koric, MPP; Zac Carter, BS; Zachary C. Arnold, BS; Katherine Schwei, BS; Kylee Tokita, BS; Leslie M. Cepeda-Echeverria; Ninoska De Jesus; and Jeremiah L. Dortch, BS. Drs. Hegmann and Thiese also conducted research for this guideline. Dr. Harris served as the Opioids Panel methodologist.

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Keywords:

guidelines; opioids; opiates; narcotics; motor vehicle crashes; safety; occupation; work

Copyright © 2014 by the American College of Occupational and Environmental Medicine

Acoem Practice Guidelines 2nd Edition 2004 Chapter 11

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