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      We read with great interest the Letters to the Editor written in response to our article discussing the use of buprenorphine maintenance therapy in opioid-addicted health care professionals, and we are encouraged by the discussion that continues to evolve around this important issue. We are pleased that our review has generated so much conversation from those on the front lines of addiction medicine and welcome the opportunity to reply to the letters from Drs Earley, Newman, Selzer and Stancliff, and Fiscella.
      Regarding the quality of research reviewed, Dr Fiscella asserts that our conclusions are based on “weak science and flawed assumptions,” citing small sample size, nonrandomized study design, and failure to account for the possibility of preexisting neurocognitive deficits among other limitations as reasons to support his position that buprenorphine use should not preclude one from a return to clinical practice after treatment for substance abuse. Dr Fiscella also asserts that, because none of these studies were performed with actual health care professionals, any conclusions regarding the presence or absence of neurocognitive effects cannot be extrapolated to this group. Although we agree that the available studies have limitations, they hardly qualify as “weak science,” and the concerns that he raises are not based in fact. Dr Fiscella claims that the studies were not randomized, yet the studies that we cited performed by Soyka et al in 2005
      • Soyka M.
      • Hock B.
      • Kagerer S.
      • Lehnert R.
      • Limmer C.
      • Kuefner H.
      Less impairment on one portion of a driving-relevant psychomotor battery in buprenorphine-maintained than in methadone-maintained patients.
      and 2008
      • Soyka M.
      • Lieb M.
      • Kagerer S.
      • et al.
      Cognitive functioning during methadone and buprenorphine treatment: results of a randomized clinical trial.
      and by Mintzer et al in 2004
      • Mintzer M.Z.
      • Correia C.J.
      • Strain E.C.
      A dose-effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers.
      did, in fact, use a randomized, double-blind design. Dr Fiscella claims that the studies fail to distinguish between long- and short-term maintenance therapy, but it is unclear what he means by this. The 2008 study by Jensen et al
      • Jensen M.L.
      • Sjogren P.
      • Upton R.N.
      • et al.
      Pharmacokinetic-pharmacodynamic relationships of cognitive and psychomotor effects in intravenous buprenorphine infusion in human volunteers.
      evaluated single-dose effects, whereas the 2004 study by Mintzer et al
      • Mintzer M.Z.
      • Correia C.J.
      • Strain E.C.
      A dose-effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers.
      looked at dosage differences with study participants taking a particular dose for 7 to 10 days with performance assessment at 3 different time points, and the 2009 study by Messinis et al
      • Messinis L.
      • Epameinondas L.
      • Andrian V.
      • et al.
      Neuropsychological functioning in buprenorphine maintained patients versus abstinent heroin abusers on naltrexone hydrochloride therapy.
      evaluated participants who had been taking buprenorphine for 18 to 28 weeks. The results of these and the other studies included in our review, regardless of the design, are very consistent. Each of the peer-reviewed and published studies cited in our article reported similar disadvantageous effects on neurocognitive performance when patients were under the influence of buprenorphine. Whether undergoing short- or long-term therapy, healthy volunteers and recovering addicts alike demonstrated evidence of impairment. This in and of itself is troubling and, as was clearly stated in our article,
      • Hamza H.
      • Bryson E.O.
      Buprenorphine maintenance therapy in opioid-addicted health care professionals returning to clinical practice: a hidden controversy.
      we believe that further studies need to be conducted that specifically examine the influence of buprenorphine on the ability of health care professionals to perform tasks directly related to their roles as clinicians.
      Drs Selzer and Stancliff seem to suggest that we chose to include only poorly designed studies to support our conclusion that caution should be used when prescribing buprenorphine in this population. In fact, we reviewed all of the published literature on the topic and came to the same conclusion as Drs Selzer and Stancliff did: the literature on the topic of the cognitive effects of buprenorphine is limited and more research is needed. This view is shared by Dr Earley and others, who echo the need for more definitive research. Weakness in the existing literature should underscore the need for caution, not serve as a call to press forward. We challenge Drs Selzer and Stancliff and others who are actively involved in the treatment of addicted health care professionals to design and conduct better studies to fill the current knowledge gap. Until then, we stand by our recommendation that caution should be the default position.
      Regarding our study design, Drs Selzer and Stancliff suggest that our skills in engaging the representatives of the various professional health programs is somewhat lacking. Although Drs Selzer and Stancliff responded to our initial e-mail query immediately and shared their program's policies and practices without hesitation, this was unfortunately not the case with representatives from every program. Multiple attempts were made to obtain this information, but when these attempts were (in some cases) met with referral to legal counsel, we took this as an indication that the programs did not wish to share their policies. Regarding “secretive practices,” these actions speak for themselves. If the table we composed is not clear enough, perhaps this is due to the constraints inherent with concisely describing the various and sundry policy statements from 51 different locations. It would seem that this is further evidence that the time has come to introduce a single set of policies shared by all states and districts.
      The comment of Drs Selzer and Stancliff that “much in this article is informed by bias rather than science” deserves a direct reply. The use of the word bias in this context implies that a conflict of interest exists and that one or both of us may stand to benefit in some way from the decreased use of buprenorphine in the (relatively small) population of health care professionals who are maintained with this drug. Because the ability to prescribe this drug is the source of considerable income for some, we feel the need to strongly reaffirm that this is not the case with us. Neither of us has any interest, financial or otherwise, in the promotion or detraction of buprenorphine's use in the treatment of persons addicted to opioids. According to the Drug Addiction Treatment Act, the ability to prescribe buprenorphine for the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements and who have notified the Secretary of Health and Human Services of their intent to prescribe this product for the treatment of opioid dependence. Physicians must become certified to prescribe buprenorphine
      Buprenorphine: Physician and Treatment Locator
      for treatment of opioid dependence, after which they are assigned a unique identification number that must be included on every prescription written for this purpose. We are not certified to prescribe this drug and do not benefit from its use in any manner. We agree that buprenorphine has a legitimate use in addiction treatment, but, as pointed out by Dr Earley, it hardly makes sense to use it in this population of health care professionals when the proven track record of abstinence-based therapy is so strong.
      Regarding our conclusions, Dr Fiscella proposes that even if buprenorphine is found to have significant neurocognitive effects, it would be “wrong” to disallow its use in health care professionals who wish to practice clinically. He even goes so far as to suggest that to require neurocognitive testing before return to clinical practice would be cost prohibitive. This assertion is irrational, is dangerous, and minimizes the important role that health care workers have in our modern health care system. If we do not allow an individual under the influence of opioid maintenance therapy to pilot a plane or drive a school bus or tractor trailer, why then is it wrong to suggest that we should take a closer look at the practice of allowing a surgeon or an anesthesiologist to perform surgery or provide anesthesia while taking buprenorphine? We believe it is both self-serving for the medical practitioner in recovery and somewhat irrational from a neurophysiologic perspective to argue that an individual who is managing addiction and requires opioid maintenance therapy should not be held to the same high standards as workers in other safety-sensitive positions.
      We strongly disagree with Dr Fiscella's assertion that the absence of direct evidence should be a reason to continue the practice of allowing health care professionals to practice while maintained with buprenorphine until it is deemed unsafe. Lack of evidence of effect is not the same as lack of effect. In the interest of patient safety we believe that the more conservative and thoughtful approach would be to first conduct appropriate investigations to determine whether the practice is safe before allowing an individual to practice while taking this drug. Given the extremely high success rates of abstinence-based recovery programs for health care professionals, as pointed out by Dr Earley, we believe that asking a trained nurse or physician to discontinue opioid maintenance therapy before returning to clinical practice is hardly draconian. We find it difficult to accept the assertion that individuals have some form of right to return to clinical practice under the influence of this drug when to do so has the potential to significantly affect patient safety.
      Unfortunately, it appears that Dr Newman has missed the point of our review altogether. He suggests that we somehow “reject” the use of buprenorphine when it comes to colleagues who want and need the help of this drug, but this is not at all the case. What we reject is the assertion that buprenorphine is some kind of “magic bullet” that has no negative or unintended effects. We accept that for some people maintenance therapy is the only option and that there will always be some patients who are unable to abstain from drugs of abuse without it, but just because a therapy works doesn't mean it is without adverse effects. He points out that maintenance treatment of addiction has been strongly endorsed by the highest governmental authorities, yet fails to point out that these same authorities limit the activities that may be performed by patients while they are undergoing this very same maintenance therapy. Are we then to accept that providing medical care requires less attention to detail than driving a bus?
      Dr Newman believes that our recommendation that health care professionals maintained with buprenorphine not be allowed to return to clinical practice until it is determined that they are not cognitively impaired is unreasonable, but he fails to acknowledge that this is the majority position of the individual physician health programs and nursing programs we queried. Dr Newman suggests that we might very well extend this policy to those taking benzodiazepines, opioids, or other medications for reasons other than maintenance therapy, as if the indication for which a drug is prescribed somehow lessens its effect. Although this statement may have been made tongue-in-cheek, we do not believe that it is an unreasonable policy to promote when the outcome can only increase patient safety. We therefore stand by our recommendation that when the patient is an individual whose job performance has the potential to adversely affect others, it is reasonable to make sure he/she is not impaired before returning to work.

      References

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        • Hock B.
        • Kagerer S.
        • Lehnert R.
        • Limmer C.
        • Kuefner H.
        Less impairment on one portion of a driving-relevant psychomotor battery in buprenorphine-maintained than in methadone-maintained patients.
        J Clin Psychopharmacol. 2005; 25: 490-493
        • Soyka M.
        • Lieb M.
        • Kagerer S.
        • et al.
        Cognitive functioning during methadone and buprenorphine treatment: results of a randomized clinical trial.
        J Clin Psychopharmacol. 2008; 28: 699-703
        • Mintzer M.Z.
        • Correia C.J.
        • Strain E.C.
        A dose-effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers.
        Drug Alcohol Depend. 2004; 74: 205-209
        • Jensen M.L.
        • Sjogren P.
        • Upton R.N.
        • et al.
        Pharmacokinetic-pharmacodynamic relationships of cognitive and psychomotor effects in intravenous buprenorphine infusion in human volunteers.
        Basic Clin Pharmacol Toxicol. 2008; 103: 94-101
        • Messinis L.
        • Epameinondas L.
        • Andrian V.
        • et al.
        Neuropsychological functioning in buprenorphine maintained patients versus abstinent heroin abusers on naltrexone hydrochloride therapy.
        Hum Psychopharmacol. 2009; 24: 524-531
        • Hamza H.
        • Bryson E.O.
        Buprenorphine maintenance therapy in opioid-addicted health care professionals returning to clinical practice: a hidden controversy.
        Mayo Clin Proc. 2012; 87: 260-267
        • Buprenorphine: Physician and Treatment Locator
        (SAMHSA Web site) (Accessed June 11, 2012)
      1. Suboxone (buprenphine).
        (Accessed June 11, 2012)

      Linked Article

      • Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals Returning to Clinical Practice: A Hidden Controversy
        Mayo Clinic ProceedingsVol. 87Issue 8
        • Preview
          The article by Hamza and Bryson1 cites several studies to support their opinion that health care professionals should not be returned to practice if their treatment includes opioid agonist therapy. The quality of the evidence cited is poor. Three of the studies2-4 evaluate the effects of buprenorphine in “healthy volunteers” rather than in patients after careful dose titration. Other studies are small and poorly controlled for the duration of therapy and other drug use. The most relevant study5 compares patients taking buprenorphine with those taking naltrexone.
        • Full-Text
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      • Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals Returning to Clinical Practice
        Mayo Clinic ProceedingsVol. 87Issue 8
        • Preview
          Hamza and Bryson1 argue against health care professionals returning to clinical practice while taking buprenorphine, based on purported neurocognitive effects. Their argument is based on weak science and flawed assumptions. Studies examining neurocognitive effects associated with buprenorphine are mostly based on small, selected samples and frequently fail to account for preexisting neurocognitive function or to distinguish between short- and long-term effects (after development of full tolerance) of the drug.
        • Full-Text
        • PDF
      • Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals Returning to Clinical Practice: A Hidden Controversy
        Mayo Clinic ProceedingsVol. 87Issue 3
        • Preview
          It remains controversial whether it is safe for recovering health care professionals to return to clinical practice after treatment for drug addiction. One specific component of reentry that remains particularly contentious is the use of pharmacotherapeutics, specifically buprenorphine, as opioid substitution therapy for health care professionals who wish to return to clinical work. Because health care professionals are typically engaged in safety-sensitive work with considerable consequences when errors occur, abstinence-based recovery should be recommended until studies demonstrate that it is safe to allow this population to practice while undergoing opioid substitution therapy.
        • Full-Text
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      • Opioid Substitution Therapy for Dependent Health Care Practitioners: Approach With Caution
        Mayo Clinic ProceedingsVol. 87Issue 8
        • Preview
          In a recent article in Mayo Clinic Proceedings, Hamza and Bryson visit the difficult decisions involved in returning addicted health care practitioners (HCPs) back to work; their article focuses on maintenance therapy of addiction disorders with opioid maintenance therapy. Specifically, they propose that “abstinence-based recovery should be recommended until studies demonstrate that it is safe to allow this population to practice while undergoing opioid substitution therapy.”1 They review the current (and limited) research on the cognitive effects of opioid medications, including buprenorphine.
        • Full-Text
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      • Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals
        Mayo Clinic ProceedingsVol. 87Issue 8
        • Preview
          In their article entitled “Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals,”1 Hamza and Bryson draw a distinction between a “harm reduction and damage control model” of opioid-addiction management and treatment for which abstinence (including, very specifically, abstinence from prescribed agonists) defines both the treatment process and its therapeutic objective. The authors' notion that there is an inherent contradiction between continued prescribing of medication and a patient's “recovery” and the suggestion that reducing harm and controlling damage are not part and parcel of any practice of medicine are extraordinary.
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