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10 Articles in Volume 17, Issue #7
Abuse-Deterrent Opioids: Why Rush to Judgment?
Alcohol Screen Recommended to Reduce Opioid-Induced Respiratory Depression Overdose
Ehlers-Danlos Syndrome: An Emerging Challenge for Pain Management
Guide to Laboratory Testing in Patients With Suspected Rheumatic Disease
Letters to the Editor: Arachnoiditis, Hormone Testing, Ehlers-Danlos Syndrome
Neurocognitive Disorders: Pain Expression in the Face of Mental Deficits
Preemptive and Preventive Analgesia for Chronic Postsurgical Pain
The Effects of Religion and Spirituality on Coping Efficacy for Death and Dying
Topical Nonsteroidal Anti-inflammatory Drugs and Nephrotoxicity: Is There a Safer Option?
Transformative Care for Chronic Pain and Addiction

Abuse-Deterrent Opioids: Why Rush to Judgment?

Three nationally recognized experts in pain management offer a critical view of the expectations placed on abuse-deterrent opioids as the answer to opioid abuse and the unreasonable position against any value for long-term opioid use.

In a recent New England Journal of Medicine perspective, William Becker, MD, and Daniel Fiellin, MD, commented on the potential benefits of abuse-deterrent formulations (ADFs) for opioid analgesics.1 In the article, they reasonably suggested tempering expectations, as they voiced criticism of both the extant data on ADFs as well as on long-term opioid therapy in general.

All three of us have extensive clinical backgrounds working with patients who have chronic pain and addiction. These are frequently settings wherein expert pain physicians combine their knowledge of pharmacology and pain with others’ expertise in the assessment and management of psychological comorbidities and addiction-related concerns.

We can attest to the fact that our experiences with opioids for chronic pain over that time were generally positive. Patients benefited from the combining of opioids, nonopioids, interventional and psychological therapies along with physical medicine and rehabilitative therapies. They benefited from our knowledge of opioid safety and experience with multiple tools meant to help patients maintain control and adherence. Many patients returned to living productive lives, with a minimum of diversion, addiction, and loss of control, and with only rare overdoses. Thus, we view as worthwhile preserving access to opioid therapy for patients who need it (a judgment not based solely on our anecdotal experiences; see below), and we welcome any advances in tools or techniques that might lead to improved opioid safety.

That said, our patients, compliant and otherwise, were treated against a backdrop of a society that included individuals from many diverse subgroups who were seeking access to opioids for self-medication of pain or addiction, or for diversion. People within their own household, be they family members or even visitors, might have sought to divert these medications.

The pharmaceutical industry, as encouraged by the US Food and Drug Administration (FDA), has been attempting to develop opioid formulations less susceptible to tampering and alteration—this was not initially, nor simply, an industry-inspired initiative meant solely to have more expensive opioids to sell, as the authors of the editorial implied. Much work and ingenuity have gone into the search, in coordination with guidance from the federal government.

Drs. Becker and Fiellin raise several points in their piece with which we wholeheartedly agree, not the least of which is that the potential benefits of abuse-deterrent opioids must be kept in perspective. We would add that we should take the same view of any single intervention meant to augment opioid safety and help curtail abuse and diversion, be it urine drug testing, prescription drug monitoring programs, psychotherapeutic approaches, give-back programs, genetic testing, etc. The complex and intertwined dual epidemics of poorly treated pain and opioid addiction require a combined, artful approach to secure the best possible results for patients while preventing misuse, abuse, diversion, and overdose.

We also agree, if clinicians have a false sense of security that these formulations are safer in a range of ways that obviates the need to enact and use all the other tools our teams commonly employed, that would be unfortunate. Additionally, we concur that we need nonopioid and non-drug approaches, and we need them to be covered by payers (private insurance carriers and Medicaid and Medicare). Payers should not simply shuttle more people to opioids because these formulations exist. However, if a patient has failed other approaches, it is still important to have potentially safer opioid formulations available.  

The authors are correct in saying that one of the main ways that opioids are abused by people in pain is ingestion of a greater number of intact tablets than prescribed and that ADFs, as they currently exist, would not guard against this manner of overuse. However, the overall picture of pathways to addiction is not limited to this one simple linear progression.2

They would likely agree with us that there are many trajectories to addiction in both people with pain and those simply abusing diverted medications. Also, the inability to alter a dose form might provide an ounce of prevention when, at a moment of weakness, a person feels cravings or urges to intensify their mode of abuse and switches to crushing, chewing, snorting, or injecting, which research indicates are more dangerous forms of abuse than oral.3

The harm reduction associated with abuse-deterrent opioids, and the decrease in societal harms and costs in having these formulations, must also be taken into account—with regard to both the lives saved in preventing abuse and addiction in those who divert these medications, and in the costs associated with treating them. Two recent studies, one in the US and one in Canada, came to markedly different conclusions on whether ADFs are cost-effective.4,5 The US-based study left diversion-related costs out of the model while the Canadian study included them; needless to say, the Canadian study estimated great cost benefits to the healthcare system. Both studies suggested a significant impact on abuse.

While the table included in Becker and Fiellin’s article lists multiple abuse-deterrent opioids, the truth is that several were recently approved and many are not even being marketed. The uptake in the marketplace has been slow, in no small part due to payer policies that require prior authorization and failure of non-ADF formulations before a patient can gain access to an ADF. About whether these policies are potentially socially irresponsible or not, we are likely to disagree with the authors. But we likely would agree that it is very early in the history of ADFs to make a final judgment about their clinical and societal utility. This is especially true given the fact that all the extant data used in these analyses is based on one ADF product utilizing a first-generation technology. It is ironic that epidemiologic data on the effectiveness of ADFs cannot be gathered without sufficient market penetration, but market penetration is impeded by payer policies due to the lack of sufficient data on effectiveness.

Finally, the argument that opioids simply don’t work in the long term is inconsistent with a large body of clinical trial data, including over 15 randomized, placebo-controlled trials performed for FDA approval of these medications, with long-term uncontrolled extensions.6 It is not a coincidence that FDA policy calls for 3-month studies for approval for chronic conditions and all published studies lasted 3 months, as is the case for virtually all other analgesics for chronic pain. We would agree with complaints that studies should be longer. However, until the National Institute of Health or another non-industry funder decides to start funding clinical trials of opioids for chronic pain, or the FDA compels industry to conduct longer studies, this is unlikely.  

We would argue that there is too much at stake here to rush to judgment. There has been far too much emphasis on recent policy and debate on reducing the number of opioid exposures rather than on improving the quality of the exposures that do occur. The prevention of abuse, addiction, overdose, and death is important—but so, too, is keeping access to these products in their safest possible forms available for the millions of Americans who need them.  

Let us continue to have this debate. Opioid prescribing was initially expanded in order to relieve uncontrolled pain, without sufficient honest attention to curbing the potential for safety issues for those prescribed the medications and those beyond the patients. It would be equally intellectually dishonest to push back on them to the bad old days of opiophobia without honest discourse and study. We applaud Drs. Becker and Fiellin for contributing to this debate.

Last updated on: October 5, 2017
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Preemptive and Preventive Analgesia for Chronic Postsurgical Pain

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