The ongoing media maelstrom regarding opioids and classification of an "opioid crisis" during the initial decade of this millennium has stirred awareness, outrage and action among regulatory and other government agencies, professional clinician organizations, community pharmacy policies, legislators, patient advocacy groups, anti-opioid advocate groups, and others. However, mass media reports often skew or misdirect the aggregate facts in a possible effort to abridge or sensationalize stories. 1 Discernable distinctions, for example, are rarely drawn between licit pharmaceutical fentanyl, illicit fentanyl analogues, and certain highly potent analogues approved only for ungulates. The omission of this information has resulted in distorted public information that has far reaching consequences in medicine and policy development, as it leads to misunderstanding and misinterpretation of the facts by politicians, lay people and many clinicians. 2 It is particularly relevant today, as pharmaceutical fentanyl is often an essential drug for intubation regularly required for ventilation procedures in declining patients that may succumb to novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These distinctions are critical in the shifting landscape of the opioid crisis as prescriptions for opioids decrease yet overdose deaths remain alarmingly prevalent and continue to rise.Licit fentanyl was first synthesized in the 1950s via manipulation of another phenylpiperidine, meperidine, in an effort to develop a novel analgesic agent and laying the groundwork for pharmaceutical fentanyl and multiple analogues. Only a small percentage of those analogues are actually approved for medical use. 2 The remainder are dangerously potent with high binding affinity to opioid receptors and rapid entry to the CNS. These characteristics make them particularly hazardous when added to other illicit substances such as heroin, unbeknownst to the end-user with potentially deadly consequences. 3 Illicit fentanyl has had a dramatically increasing impact on opioid overdose deaths in the US over the past decade. According to provisional data from the 2018 Centers for Disease Control and Prevention, over half of the opioid-related overdose deaths in 2018 involved non-methadone synthetic opioids; the most common of which was illicitly manufactured fentanyl. 4 Perhaps more telling are the annual data released by the New Hampshire Department of Justice, with the most recent of which indicating that less than 7% of 2019 opioid overdose deaths in the state were due to prescription opioids. 5 These illicit opioids have affected the landscape of opioid abuse to the extent that the Drug Enforcement Agency (DEA) chose to emergently schedule all fentanyl-related substances (FRS) to schedule I as of February 2018.
Objective This study describes individual cancer patients’ nonuse of extended-release or long-acting (ER/LA) opioids, including periods of gap between opioid doses taken. Design Secondary analysis of a three-month observational study of prescribed ER/LA opioids monitored using electronic pill caps. Setting Two outpatient oncology clinics of a large health system in the Mid-Atlantic region. Participants Inclusion was based on self-identified African Americans and whites, at least 18 years old, diagnosed with solid tumors or multiple myeloma. For the current analysis, the additional inclusion criterion was prescription of an oral ER/LA opioid for cancer pain to be taken around the clock. Methods The electronic monitoring period for each study participant was partitioned into intervals of days between days with one or more openings (using medication event monitoring systems) representing rates of ER/LA opioid nonuse over consecutive days and over time. Results Of the sample (N = 109), two-thirds of the cancer patients had some nonuse of prescribed ER/LA opioids, with one in four having nonuse during 31.5–87.5% of their electronic-monitoring periods. Nonuse over periods of five or more, six or more, and seven or more consecutive days occurred for 37.6%, 34.9%, and 30.3% of the participants, respectively. Conclusions About one in three ambulatory cancer patients in this study had substantial gaps between days of ER/LA opioid use, potentially resulting in risk of overdose depending upon the prescribed ER/LA opioid type, dose, and length of the time the opioid was stopped and resumed at the previous dose. This phenomenon has received little to no attention in the opioid safety discourse.
Introduction:Opioid dose tapers are used frequently when cross-titrating from one or more opioids to another or when discontinuing therapy. Currently, there is no universally accepted evidence-based standard of care for this procedure which can leave patients at risk for withdrawal symptoms, inadequate pain control, or elevated suicide risk. Objective: The objective of this study was to examine practices and rationale among clinicians, to determine if there is a difference among respondents in their comfort level, method and rationale for tapering opioids at various morphine milligram equivalents (MME) and to assess the need for the development of a standard of care. Methods: Data were derived from an electronic survey developed using SurveyMonkey ® . The survey was disseminated via e-mail listservs, social media, and professional organizations. Data were collected regarding profession, confidence tapering opioids at varying total MME, method and rationale for tapering, and pharmacologic management of withdrawal symptoms. Pearson's Chi squared and Fisher's exact tests were used to assess statistical significance of results. Results: A total of 149 clinicians completed the survey, physicians, NPs, pharmacists, and PAs accounted for 51%, 20%, 19%, and 10% of participants, respectively. Overall, 55% of the respondents self-identified as pain specialists. There were no statistically significant differences in reported comfort level among the different types of providers. Nearly 50% of participants indicated their rationale for tapering or discontinuing opioids was the 2016 CDC guidelines. Conclusion: Despite that the majority of providers surveyed self-identified as pain specialists, over 50% were not comfortable tapering opioids at doses greater than 120 MME/day. This observation suggests a need for further education and establishment of consensus guidelines on method and rationale for opioid tapering. Provider motivation for tapering was largely influenced by CDC guidelines based on low quality evidence. This strengthens the argument for the creation of guidelines based on high quality evidence.
Over the past decade, opioid use has been at the forefront of a public health crisis throughout the United States (US). The US Centers for Disease Control and Prevention (CDC) reported opioid overdose deaths increased from 4030 to 16,917 between 1999 and 2011. 1 This increase was accompanied by a corresponding uptick in opioid prescribing. In fact, increases in opioid-prescribing paralleled increases in morbidity, mortality, opioid-related overdose death rates, and substance-use-disorder-treatment admissions from 2006 to 2012. 2 In response to the tremendous negative societal, personal, and economic impacts that this growing public health crisis (also called the "opioid crisis" or "opioid epidemic") caused, several governmental agencies began to respond. In 2016, the CDC developed and published a controversial set of guidelines on the prescribing of opioids for chronic pain, which, in part, included limits of morphineequivalent daily doses (MEDD) to ⩽90 mg/day for anyone on long-term opioids. 3 Such a cap could be more harmful than good given the widespread lack of understanding for the variation in potency, receptor-binding, affinity, physical tolerance, and pharmacokinetic properties among different opioids. Furthermore, there are inconsistencies among MEDD calculators which limit reliable conversion from one opioid to another. 4 In addition to concerns related to MEDD, the conclusions drawn in the CDC guidelines are largely based on poor quality evidence and, it is noted that no pharmacists were included in the author panel. 5,6 Perhaps, most concerning is the fact that these misguided
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