Faculty Bibliography

OBJECTIVES/OBJECTIVE:The opioid overdose epidemic continues to claim the lives of tens of thousands of Americans every year. Increased access to the opioid antagonist naloxone can reduce opioid-related morbidity and mortality. In this commentary, we describe several recent legal innovations designed to encourage pharmacists to ensure that naloxone is available when and where it is needed, and dispel some common misconceptions regarding potential legal risks associated with pharmacy naloxone dispensing. DATA SOURCES/METHODS:Data are drawn from state laws and regulations, as catalogued by the Westlaw database. SUMMARY/CONCLUSIONS:States have rapidly modified law and policy to increase layperson access to naloxone. As of August 2016, 44 states permit naloxone to be prescribed for administration to a person with whom the prescriber does not have a prescriber-patient relationship. Forty-two states permit naloxone to be dispensed via a non-patient-specific mechanism such as a standing or protocol order, and 5 states permit some pharmacists to prescribe naloxone on their own authority. The liability risk associated with naloxone dispensing is no higher than any other medication, and may be lower than some. However, to encourage the prescription and dispensing of naloxone, 36 states provide additional protection from civil liability for pharmacy naloxone dispensing, and 32 states provide protection from potential criminal action. Naloxone access laws in 31 states explicitly provide that dispensing naloxone as permitted by law cannot be grounds for disciplinary action by the state board of pharmacy or similar entity. CONCLUSION/CONCLUSIONS:Pharmacists are key members of the health care team and are uniquely situated to reduce potential opioid overdose risk. Pharmacists should be aware of and utilize innovative state laws designed to increase access to naloxone.

The opioid overdose epidemic claims the lives of tens of thousands of Americans every year. Opioid overdose is reversible by the administration of naloxone, a pure antagonist now available in formulations specifically designed and labeled for layperson use. Despite broad support for layperson access to naloxone from professional organizations, health officials, and clinical experts, qualitative studies suggest that some providers have concerns about legal risks associated with naloxone prescribing, particularly co-prescribing naloxone to pain patients. Such concerns are unfounded. The legal risk associated with prescribing naloxone is no higher than that associated with any other medication and is lower than many. Additionally, laws in a majority of states provide explicit legal protections for providers who prescribe or dispense naloxone, in many cases extending this protection to prescriptions issued to friends, family members, and others. In this large and increasing number of states, the liability risk of prescribing or dispensing naloxone in good faith to a patient at risk of overdose (or, in states where such prescribing is permitted, to an associate of such a patient) is either extremely low or absent entirely. Where a prescriber determines, in his or her clinical judgment, that a patient is at risk of overdose, co-prescribing naloxone is a reasonable and prudent clinical and legal decision. No clinician should fail or refuse to issue such a prescription based on liability concerns.

In March of 2015, the United States Department of Health and Human Services identified 3 priority areas to reduce opioid use disorders and overdose, which are as follows: opioid-prescribing practices; expanded use and distribution of naloxone; and expansion of medication-assisted treatment. In this narrative review of overdose prevention and the role of prescribers and pharmacists in distributing naloxone, we address these priority areas and present a clinical scenario within the review involving a pharmacist, a patient with chronic pain and anxiety, and a primary care physician. We also discuss current laws related to naloxone prescribing and dispensing. This review was adapted from the Prescribe to Prevent online continuing medical education module created for prescribers and pharmacists (http://www.opioidprescribing.com/naloxone_module_1-landing).

Fatal opioid overdose, the leading cause of injury death in the USA, is regularly described as an epidemic. The response to the overdose crisis, however, has largely failed to utilise many of the public health tools that have proven effective in combating epidemics. Chief among these is the systematic and timely use of data by public health officials to track outbreaks and effectively target interventions. This failure is particularly acute regarding data from prescription monitoring programmes, which are routinely used by clinicians and law enforcement agents, but often unavailable to health officials. We argue for a shift in emphasis and resources towards an evidence-based public health approach to data use for overdose prevention. [Davis CS, Green TC, Zaller ND. Addressing the overdose epidemic requires timely access to data to guide interventions. Drug Alcohol Rev 2016;35:383-386].

BACKGROUND:The opioid overdose epidemic in the United States is driven in large part by inappropriate opioid prescribing. Although most American physicians receive little or no training during medical school regarding evidence-based prescribing, substance use disorders, and pain management, some states require continuing medical education (CME) on these topics. We report the results of a systematic legal analysis of such requirements, together with recommendations for improved physician training. METHODS:To determine the presence and characteristics of CME requirements in the United States, we systematically collected, reviewed, and coded all laws that require such education as a condition of obtaining or renewing a license to practice medicine. Laws or regulations that mandate one-time or ongoing training in topics designed to reduce overdose risk were further characterized using an iterative protocol RESULTS:Only five states require all or nearly all physicians to obtain CME on topics such as pain management and controlled substance prescribing, and fewer than half require any physicians to obtain such training. CONCLUSIONS:While not a replacement for improved education in medical school and post-graduate clinical training, evidence-based CME can help improve provider knowledge and practice. Requiring physicians to obtain CME that accurately presents evidence regarding opioid prescribing and related topics may help reduce opioid-related morbidity and mortality. States and the federal government should also strongly consider requiring such training in medical school and residency.

Recently, an extensive study of 2,748 polar bears (Ursus maritimus) from across their circumpolar range was published in PLOS ONE, which used microsatellites and mitochondrial haplotypes to apparently show altered population structure and a dramatic change in directional gene flow towards the Canadian Archipelago-an area believed to be a future refugium for polar bears as their southernmost habitats decline under climate change. Although this study represents a major international collaborative effort and promised to be a baseline for future genetics work, methodological shortcomings and errors of interpretation undermine some of the study's main conclusions. Here, we present a reanalysis of this data in which we address some of these issues, including: (1) highly unbalanced sample sizes and large amounts of systematically missing data; (2) incorrect calculation of FST and of significance levels; (3) misleading estimates of recent gene flow resulting from non-convergence of the program BayesAss. In contrast to the original findings, in our reanalysis we find six genetic clusters of polar bears worldwide: the Hudson Bay Complex, the Western and Eastern Canadian Arctic Archipelago, the Western and Eastern Polar Basin, and-importantly-we reconfirm the presence of a unique and possibly endangered cluster of bears in Norwegian Bay near Canada's expected last sea-ice refugium. Although polar bears' abundance, distribution, and population structure will certainly be negatively affected by ongoing-and increasingly rapid-loss of Arctic sea ice, these genetic data provide no evidence of strong directional gene flow in response to recent climate change.

BACKGROUND:In an effort to prevent opioid overdose mortality among Veterans, Department of Veterans Affairs (VA) facilities began implementing opioid overdose education and naloxone distribution (OEND) in 2013 and a national program began in 2014. VA is the first national health care system to implement OEND. The goal of this study is to examine patient perceptions of OEND training and naloxone kits. METHODS:Four focus groups were conducted between December 2014 and February 2015 with 21 patients trained in OEND. Participants were recruited from a VA residential facility in California with a substance use disorder treatment program (mandatory OEND training) and a homeless program (optional OEND training). Data were analyzed using matrices and open and closed coding approaches to identify participants' perspectives on OEND training including benefits, concerns, differing opinions, and suggestions for improvement. RESULTS:Veterans thought OEND training was interesting, novel, and empowering, and that naloxone kits will save lives. Some veterans expressed concern about using syringes in the kits. A few patients who never used opioids were not interested in receiving kits. Veterans had differing opinions about legal and liability issues, whether naloxone kits might contribute to relapse, and whether and how to involve family in training. Some veterans expressed uncertainty about the effects of naloxone. Suggested improvements included active learning approaches, enhanced training materials, and increased advertisement. CONCLUSIONS:OEND training was generally well received among study participants, including those with no indication for a naloxone kit. Patients described a need for OEND and believed it could save lives. Patient feedback on OEND training benefits, concerns, opinions, and suggestions provides important insights to inform future OEND training programs both within VA and in other health care settings. Training is critical to maximizing the potential for OEND to save lives, and this study includes specific suggestions for improving the effectiveness and acceptability of training.

BACKGROUND:Opioid overdose, which has reached epidemic levels in the United States, is reversible by administration of the medication naloxone. Naloxone requires a prescription but is not a controlled substance and has no abuse potential. In the last half-decade, the majority of states have modified their laws to increase layperson access to the medication. METHODS:We utilized a structured legal research protocol to systematically identify and review all statutes and regulations related to layperson naloxone access in the United States that had been adopted as of September, 2015. Each law discovered via this process was reviewed and coded by two trained legal researchers. RESULTS:As of September, 2015, 43 states and the District of Columbia have passed laws intended to increase layperson naloxone access. We categorized these laws into three domains: (1) laws intended to increase naloxone prescribing and distribution, (2) laws intended to increase pharmacy naloxone access, and (3) laws intended to encourage overdose witnesses to summon emergency responders. These laws vary greatly across states in such characteristics as the types of individuals who can receive a prescription for naloxone, whether laypeople can dispense the medication, and immunity provided to those who prescribe, dispense and administer naloxone or report an overdose emergency. CONCLUSIONS:Most states have now passed laws intended to increase layperson access to naloxone. While these laws will likely reduce overdose morbidity and mortality, the cost of naloxone and its prescription status remain barriers to more widespread access.