Pain Management and Prescription Opioid-Related Harms Exploring the State of the Evidence: Proceedings of a Workshop—in Brief (2016) / Chapter Skim
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Pain Management and Prescription Opioid-Related Harms: Exploring the State of the Evidence: Proceedings of a Workshop - in Brief
Pain Management and Prescription Opioid-Related Harms: Exploring the State of the Evidence: Proceedings of a Workshop - in Brief
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and others can take to address the opioid epidemic while taking into account individual need for pain control, including FDA's development of a formal method to incorporate the broader public health impact of prescription opioids into its future approval decisions regarding opioids.1 This workshop was designed to bring the committee and the public together to hear presentations and hold discussions on issues that are relevant to this task and to inform the committee's deliberations. Specifically, the purpose of this workshop was to gather information about the state of the science and potential best practices in pain management, including the evolving role of opioids in pain management; to understand the epidemiology of the prescription opioid epidemic and discuss possible strategies to address it; and to identify potential areas for future research in the field.
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Thomas proposed his idea that one of the ways prescription drug abuse starts is with inadequate pain treatment, observing that areas such as Appalachia that suffer from high opioid death rates are the same areas that are medically underserved. He theorized that when people cannot access effective pain treatment, or when "we just throw opioids at them and let them out the door," this is a "prescription for trouble." With this in mind, the workshop turned toward a discussion about progress in research on pain management and strategies to address the prescription opioid epidemic.
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Woolf said that identifying targets for novel analgesics is contingent on understanding the neurobiology of pain and developing products that act on the particular pain mechanisms of the particular patient. He noted that the mechanisms that produce pain are "diverse and complex and vary from one patient to the other," and that the traditional approach of "treating pain as a single entity is both inadequate and incorrect." Woolf said that while there has been some progress in identifying potential targets, there is a need for "a massive investment in understanding the molecular biology underlying pain mechanisms and … until that investment occurs, we are not going to make progress that is going to transform our approach to the management of pain." Woolf told participants that most failures in drug development are failures of efficacy and that to develop more efficacious drugs developers need to focus on understanding genetic variance and new techniques for identifying effective targets and measuring pain.
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However, Fields said that there are several barriers to developing an opioid drug that would provide analgesia without the reward, including a lack of knowledge about the mechanisms of dependence, a lack of funding for research, and a lack of interest from pharmaceutical companies because there are many approved opioids currently on the market. Raymond observed that while these presentations and discussions about alternative approaches to treating chronic pain revealed "tantalizing lines of inquiry and potential pathways," it seems "reasonable to think that at least for the next several years we are going to be living with the opioids rather than having a substitute just around the corner." Given this situation, workshop presenters discussed ways that opioid analgesics could continue to be used for the management of pain, while at the same time reducing availability and unnecessary use of opioids.
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Dart said that after the abuse-deterrent formulation of oxycodone ER replaced the previous formulation in 2010 there was a rapid and substantial drop in a number of measures, including a reduction in the number of prescriptions for oxycodone, fewer calls to poison centers for acute events involving intentional oxycodone abuse, and fewer patients entering treatment programs who reported recent use of oxycodone. Other participants discussed ideas that could help individual patients avoid or recover from opioid use disorder.
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However, a market comprised completely of abuse-deterrent formulations would be expected to reduce opioid abuse and its outcomes, Dart said. POTENTIAL RESEARCH NEEDS Individual workshop participants identified a number of research needs related to clinical and basic research on pain and strategies to address prescription opioid-related harms.
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He noted that people on both sides of the table may resist the implementation of certain strategies to address pain and the prescription opioid epidemic because of unintended consequences; for example, reducing access to opioids in order to reduce abuse may leave people in pain with no treatment options. Raymond suggested that perhaps the focus should be on people who suffer from both chronic pain and substance use disorders -- strategies that are tailored to help this group of people might be both efficacious and mitigate unintended consequences.
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2016. Pain management and prescription opioid-related harms: Exploring the state of the evidence: Proceedings of a workshop -- in brief.
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