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      Fact or fiction: the truth behind the doctors company claims regarding licit and illicit opioids

      1 , 2 , 3 , 4 , 5 , 6 , 7

      Journal of Pain Research

      Dove Medical Press

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          Abstract

          Over 35 years ago, California was in the midst of a medical malpractice insurance crisis. Malpractice lawsuits and jury awards hit an all-time high, causing insurance companies to raise their rates by more than 300%.1 This crisis brought leading physicians together, which led to the passage of Medical Injury Compensation Reform Act (MICRA).1 The physicians recognized the need to continue to advocate and protect physicians, and thus, The Doctors Company was formed.1 The Doctors Company changed the landscape of the insurance world, as they became the first insurance carrier to be founded and led by physicians.1 As physicians led the company, the founders felt confident that they could focus on member needs rather than answering the demands of stockholders. Likewise, they believed that the company would be aligned with physicians’ interests and in an ideal position to represent and advocate for physicians in political and legal settings.1 According to the website, “The mission was clear: The Doctors Company would work relentlessly to advance, protect, and reward the practice of good medicine.”1 Does their message and vision still hold true today in a profit-driven health system? During the second quarter of 2017, the company’s publication, Doctor’s Advocate, released an article by Howard Marcus, MD: “Prescribing Opioids Safely.”2 Given the title, one would imagine that this article would educate its readers on safe opioid prescribing and risk mitigation strategies. However, this article offers very little insight for clinicians into safe opioid prescribing and appears to merely be filled with misleading “alternative facts” correlated with non-scientifically based rhetoric that has been ubiquitous among mainstream media sources and political “bully pulpits.”2 Compassionate clinicians should take pause to assess whether the author and The Doctors Company have wandered astray from the group’s initial mission, askew from their pledge to instead relentlessly advance, protect, and reward politicians and lawmakers inapposite to the Hippocratic Oath. While we certainly acknowledge the inherent dangers of prescription opioids, we also know that in appropriate patients they can be effective and preserve the will to live, lest we remember those patients who have taken their own lives due to undertreated intractable pain. According to the oath, a physician pledges to “…remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.” Accordingly, casting aside these obligations by focusing on the removal of access to opioids when indicated is a serious breach of professional obligation. Facts or fake medical news? The writer and educator, William Zinsser wrote, “The most important sentence in any article is the first one. If it doesn’t induce the reader to proceed to the second sentence, your article is dead.”3 Marcus perhaps took this to heart, captivating readers by having them consider a number of rather hyperbolic “facts”. Given the lack of citations and explanation surrounding these so-called truths, we highlight key issues to enlighten those that choose the path of informed decision. Consider these facts: The US consumes 99% of the world’s hydrocodone. The US uses hydrocodone (which milligram for milligram is presumed to be roughly equivalent to oral morphine) in combined formulations with acetaminophen, aspirin, ibuprofen, and in cold products with atropine and related alkaloids. Outside North America, dihydrocodeine, a codeine derivative and weaker analgesic compared to hydrocodone, and simply morphine itself are the drugs more commonly used for relief of mild to moderate pain.4 Hydrocodone is marketed in Canada only in cough syrups or elixirs but is not otherwise used for pain treatment.4 Hydrocodone has also been used in Australia but has largely been replaced by morphine.4 Ignoring this exclusiveness of hydrocodone skews explanations of why the US consumes the worldwide majority of hydrocodone and the reasons why hydrocodone was once prescribed more than any other medication in the US. The practical reality is that hydrocodone became preferred by physicians and other prescribers nationwide because it was the only opioid analgesic of significant potency that for many years was not a schedule II controlled substance per United States Federal Regulations.5,6 During that time span, hydrocodone combination products were classified as schedule III controlled substances, as it was originally believed that the combinations with acetaminophen, aspirin, ibuprofen, and/or atropine alkaloids were less abusable compared to other products and, with the exception of the latter, potentially more effective in treating pain.5,6 This meant that prescribers could write prescriptions for hydrocodone with up to five refills and avoid multiple patient visits for prescription renewals, which are required of oxycodone and nearly all other chronic opioid analgesics.5,6 The number of annual opioid prescriptions written in the US is roughly equal to the number of adults in the country. This statement is an example of a spurious correlation that is shamefully aligned with the agenda-driven rheto ric spewed by politicians and nonscientists. To highlight the inanity, consider the congruent correlations between the cost of bananas vs opioid deaths, points scored by losing Super Bowl team vs opioid deaths, or the cost of 16-ounces of potato chips vs opioid deaths, all of which are more closely parallel than opioid prescriptions written vs number of adults in the US.7 According to the Morbidity and Mortality Weekly Report on Changes in Opioid Prescribing in the US, the amount of opioids prescribed peaked in 2010 and has subsequently decreased each year through 2016.8 More specifically between 2006 and 2016, the annual prescribing rate decreased from 0.724 opioid prescriptions per person to 0.665 prescriptions per person for all opioids, which calculates to an 8.1% reduction in opioid prescriptions written overall.9 When considering the data from 2006 through 2016 for high-dose opioid prescribing, which was defined as a total daily dosage of ≥ 90 MME, there was a substantial 46.8% overall reduction during that 10-year span.9 These data were obtained from QuintilesIMS Transactional Data Warehouse, representing 59,000 pharmacies (88% of the prescriptions) across the US. This type of data collection poses several limitations.9 First, the QuintilesIMS estimates have not been validated. Second, the analysis does not include clinical outcomes. Lastly, the data obtained did not include the indications for which opioids were prescribed. Thus, one cannot assess the appropriateness of these medications and the setting in which they were prescribed – acute, chronic, palliative care, or end-of-life care. What exactly does “roughly equal” mean and is this in fact true? Taking a look at the data reported by the CDC’s 2017 Annual Surveillance Report (Table 1), from 2012 to 2016, there was a steady decline in the amount of opioid prescriptions written. Furthermore, from 2014 to 2016, the number of adults exceeded the annual number of opioid prescriptions written. Nine million Americans take prescribed opioids on a long-term basis. From where Dr. Marcus obtained this figure is unclear. The latest data that we could find suggest that there were actually 13 million Americans prescribed opioids as long-term opioid therapy (LTOT) in 2013–2014.10 However, given the steady annual decreases in the number of opioids prescribed since 2014, we suspect that this number has likely decreased. Irrespective of the actual number and Marcus’s source, we are confident that he presented the number as a means of alarming his readers. If 9 million is an accurate figure, is it not tragic that fewer than 10% of the 100 million suffering from chronic pain are able to access opioid analgesia on an ongoing basis, and overall deaths attributable to such a large number of prescribed opioids are therefore quite low?11 Nearly 60% of Americans have leftover opioids in their homes, and 20% have shared their opioids with others, often to help with pain management. Hendricks et al conducted a national survey among US adults with recent opioid medication use to examine the pervasiveness of sharing opioid medications, medication storage and disposal practices, and the sources of information received.12 Of the 4,836 that were sampled, 1,055 were eligible based on the past year opioid use, and of that group, 1,032 completed the survey. It is important to note that the survey was conducted from February 24 to March 16, 2015. Given the short time frame and lack of US census data on how many adults used prescription opioids within the past year, the results of this study cannot be extrapolated, and that this study sample represents all US adults cannot be verified. Frequently, agenda-driven medical writers jump to extremely inaccurate conclusions and focus on the negative aspects that a study may have revealed. If we look at these data from an alternative perspective, of the 20.7% (weighted percentage) who reported sharing opioid medications with another person, the primary reason for 73% of them was to help someone else manage his or her pain.12 Perhaps we are missing the bigger picture, with uncontrolled pain remaining a major issue. This survey sheds some positive light on the situation, including that only 1% of respondents no longer using opioid medications reported they would sell them. Dr. Marcus did not share this important information. In 2015, 19,000 Americans died of an opioid overdose, and the death rate from all opioids (including heroin) now exceeds the death rate from motor vehicle accidents. When contemplating these statistics, the important question to consider is whether the opioids are licit or illicit. In a 2017 article, the authors used the Department of Justice data from a state that breaks down deaths as caused by a licit vs illicit opioids, concluding that as many as 85% of overdose deaths that the CDC has attributed to “prescription opioids” were actually due to illicit fentanyl and its analogs and/or heroin.13 Although the media and policy makers continue to pay insufficient attention to this distinction, doing so is disingenuous – as is citing such blatantly dishonest figures. Similarly, The Hill recently released an article regarding DEA to Target Pharmacies, Prescribers in Crackdown in which the authors stated, “at least 66,000 deaths from overdoses reported, including 42,249 deaths from opioids.”14 This statistic fails to inform the reader of what percentage of opioid deaths were due to illegally obtained prescription vs nonprescription opioids. Finally, Somerville et al examined fentanyl deaths in Massachusetts over a 6-month period from 2014 to 2015, finding that 82% of the fentanyl deaths were likely due to illicitly manufactured fentanyl, with only 4% attributed to legal, pharmaceutical fentanyl.15 Polypharmacy also plays a significant role in opioid overdoses. The authors of a 2016 study found that of over 2 million patients who were prescribed opioid analgesics, 80% also were prescribed a benzodiazepine.16 There were 629 deaths involving opioid analgesics in the study, and alcohol was involved in 12.2% of the fatal overdoses involving opioid analgesics.16 Most recently, Hannah et al found an average of six potentially deadly substances in toxicologies of supposed “prescription opioid overdose decidents.”17 Dr. Marcus’s cited statistics regarding opioid overdoses and mortalities are oversimplified and clearly do not reflect the complex and more accurate picture. Poor patient outcomes or lack of prescriber knowledge? The Doctors Company article examined 272 claims between 2007 and 2015 in which opioids resulted in patient harm.2 The author cited that poor patient outcomes related to opioids are a common cause of litigation, with contributing factors including the following: Inappropriate selection and management of therapy. Errors in patient monitoring. Inadequate patient assessment for risks and contraindications to opioids. Failure in communication among providers. Insufficient documentation and/or support for clinical decision-making. Failure to take psychiatric and/or abuse history. Perhaps the poor patient outcomes related to opioids are due to lack of prescriber education.18,19 Few medical and pharmacy schools offer adequate training in pain management and addiction.18,19 Two wrongs do not make a right It is apparently convenient for critics of opioid analgesics to point fingers at politicians, industry, prescribers, and pharmacies as the culprits responsible for the opioid crisis. Policy makers, the media, and opiophobes continue to blame the pharmaceutical companies because they did not explicitly state the risks associated with opioids. It is curious that the government allows continued sales and advertisements by the tobacco industry when it clearly has a plethora of evidence that the risks far exceed the benefits, and that unlike opioids, there are no therapeutic benefits to smoking tobacco. This idea that it is acceptable to cite misleading, false, or over/understated data, statistics, and facts must change. In his efforts to sound an already deafening alarm, Dr. Marcus has done just this. The fact that our own government cites fake medical literature negatively impacts the credibility of the medical and scientific establishments. Alternative facts ultimately lead to distrust not only in our patients but also among overly stressed health care providers who have the courage to continue to treat patients with pain. Dr. Marcus works for an insurance company, yet nowhere does he note such as a blatant conflict of interest. Much has been written about the role of the insurance industry in the etiology and perpetuation of the opioid crisis. For example, it has been noted that the insurance industry’s decision to stop providing coverage for interdisciplinary pain care, which had historically involved tapering patients down from and even off their opioids, played a dramatic role in the development of the opioid crisis.20 The temporal contiguity between the insurance industry “just saying no” to interdisciplinary care and the rise of opioid diversion and abuse has not escaped notice.21,22 Additionally, the insurance industry’s failure to pay for more expensive but effective abuse deterrent formulations of opioids has certainly contributed to the figures that Dr. Marcus recklessly cites.23 The Doctors Company was developed to allegedly protect the interests of physicians. In the present climate of increasing medical malpractice with opioid prescribing recently identified as the leading cause of medication malpractice claims, Dr. Marcus’s inaccurate and irresponsible presentation of so-called facts can serve only to exacerbate the “chilling effect” on physicians already fearful of prescribing.24,25 While this sort of approach may promote the financial well-being of the Doctors Company, Dr. Marcus should be aware that he is not doing any favors to already marginalized chronic pain patients – as naive physicians may buy into the hyperbole and rhetoric that he has propagated, resulting in more opiophobia, oligoanalgesia, and needless suffering.

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          Most cited references 12

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          Characteristics of Fentanyl Overdose — Massachusetts, 2014–2016

          Opioid overdose deaths in Massachusetts increased 150% from 2012 to 2015 ( 1 ). The proportion of opioid overdose deaths in the state involving fentanyl, a synthetic, short-acting opioid with 50–100 times the potency of morphine, increased from 32% during 2013–2014 to 74% in the first half of 2016 ( 1 – 3 ). In April 2015, the Drug Enforcement Agency (DEA) and CDC reported an increase in law enforcement fentanyl seizures in Massachusetts, much of which was believed to be illicitly manufactured fentanyl (IMF) ( 4 ). To guide overdose prevention and response activities, in April 2016, the Massachusetts Department of Public Health and the Office of the Chief Medical Examiner collaborated with CDC to investigate the characteristics of fentanyl overdose in three Massachusetts counties with high opioid overdose death rates. In these counties, medical examiner charts of opioid overdose decedents who died during October 1, 2014–March 31, 2015 were reviewed, and during April 2016, interviews were conducted with persons who used illicit opioids and witnessed or experienced an opioid overdose. Approximately two thirds of opioid overdose decedents tested positive for fentanyl on postmortem toxicology. Evidence for rapid progression of fentanyl overdose was common among both fatal and nonfatal overdoses. A majority of interview respondents reported successfully using multiple doses of naloxone, the antidote to opioid overdose, to reverse suspected fentanyl overdoses. Expanding and enhancing existing opioid overdose education and prevention programs to include fentanyl-specific messaging and practices could help public health authorities mitigate adverse effects associated with overdoses, especially in communities affected by IMF. Barnstable, Bristol, and Plymouth counties in Massachusetts were investigated because of high opioid overdose death rates (estimated 29.8–34.5 per 100,000 population in 2015), and feasibility of interviewee recruitment through existing harm reduction programs in these counties ( 5 ).* To rapidly obtain a cross section of persons misusing opioids for semistructured, in-person interviews, a nonrandom sample of approximately 20 knowledgeable respondents per county was recruited with the help of harm reduction programs. Eligible persons were aged ≥18 years, lived in Massachusetts, had used illicit opioids during the previous 12 months, and had witnessed or experienced an opioid overdose during the previous 6 months. Equal numbers of men and women were recruited. Trained interviewers asked respondents about their experiences, knowledge, attitudes, and beliefs regarding opioid overdose. Interviews were audio recorded, transcribed, and thematically coded by multiple investigators. Opioid overdose death data were abstracted from medical examiner charts, which included autopsy and toxicology reports, death scene reports, and emergency medical service logs. Abstracted charts met the following criteria: the death occurred during October 1, 2014–March 31, 2015; the decedent overdosed or resided in Barnstable, Bristol, or Plymouth counties; and opioids were listed as a contributing cause of death. Postmortem toxicology tests were used to categorize deaths as involving fentanyl (regardless of presence of other drugs), heroin or morphine (i.e., no fentanyl), † or other opioids (e.g., prescription opioids). Fentanyl deaths were further categorized using death scene evidence as suspected IMF, suspected prescription fentanyl, or unknown source of fentanyl. Rapidity of overdose death was determined from available evidence, including needles inserted in decedents’ bodies, syringes found in hand, tourniquets still in place, and bystander reports of rapid unconsciousness after drug use. Demographic and overdose characteristic frequencies were examined by drug type. Among 64 interview respondents, 52% were women, 61% were aged 25–44 years, and 81% were non-Hispanic white. Ninety-one percent reported that they were trained by a Massachusetts Department of Public Health-supported overdose education and naloxone distribution program in the use of naloxone for reversing an opioid overdose; trainees are taught that opioid overdose is defined by unresponsiveness and decreased respirations ( 6 ). During the 6 months before the interview, 95% of respondents witnessed an overdose and 42% overdosed themselves. Eighty-eight percent of respondents attributed the increase in opioid overdose deaths to suspected fentanyl, and 69% reported that suspected fentanyl was now available for purchase in powdered form (consistent with IMF preparation), and not as diverted prescription medications, (e.g., Duragesic transdermal fentanyl patch) (Box). Respondents reported that suspected fentanyl could be obtained alone or mixed with heroin, and persons using heroin often did not know whether fentanyl was mixed into the heroin they purchased. Respondents’ reactions to the addition of fentanyl to the illicit drug market varied. Although some persons sought out fentanyl and others attempted to avoid it, a majority of respondents reported that opioid-seeking behaviors were not altered in response to the emergence of fentanyl. A majority of respondents who witnessed a suspected fentanyl overdose (75%) described symptoms as occurring rapidly, within seconds to minutes. Twenty-five percent reported witnessing or experiencing an overdose when fentanyl was insufflated (snorted), and the remainder reported the overdose always involved injecting fentanyl. Atypical overdose characteristics described by respondents during suspected fentanyl overdose included immediate blue discoloration of the lips (20%), gurgling sounds with breathing (16%), stiffening of the body or seizure-like activity (13%), foaming at the mouth (6%), and confusion or strange affect before unresponsiveness (6%). Seventy-five percent of respondents reported witnessing naloxone administration, administering naloxone themselves, or receiving naloxone to successfully reverse an opioid or fentanyl overdose. Among these events, 83% of respondents reported that ≥2 naloxone doses (typical nasally administered dose in Massachusetts is 2 mg/2 mL § ) per suspected fentanyl overdose were used before the person responded. Thirty percent of respondents reported using heroin or fentanyl with others present to help protect themselves from a fatal overdose. BOX Sample quotations from persons who reported using opioids and who had witnessed or experienced an opioid overdose — Barnstable, Bristol, and Plymouth counties, Massachusetts, April 2016* Illicitly manufactured fentanyl (IMF) responsible for opioid overdose deaths “So, now what they [people selling illicit drugs] are doing is they’re cutting the heroin with the fentanyl to make it stronger. And the dope [heroin] is so strong with the fentanyl in it, that you get the whole dose of the fentanyl at once rather than being time-released [like the patch]. And that’s why people are dying—plain and simple. You know, they [people using illicit drugs] are doing the whole bag [of heroin mixed with fentanyl] and they don’t realize that they can’t handle it; their body can't handle it.” Overdoses involving IMF are acute and rapid “A person overdosing on regular dope [heroin] leans back and drops and then suddenly stops talking in a middle of a conversation and you look over and realize that they’re overdosing. Not like with fentanyl. I would say you notice it [a fentanyl overdose] as soon as they are done [injecting the fentanyl]. They don’t even have time to pull the needle out [of their body] and they’re on the ground.” Naloxone reverses overdoses involving IMF; multiple doses often required “So he put half [one dose] up one nose [nostril] and half [one dose] up the other nose, like they trained us to do, and she didn’t come to. So he put water on her face and kind of slapped her, which doesn’t really make you come to [regain consciousness]. It doesn’t. So he pulled out another thing of Narcan [brand of naloxone] and he put half of it [another dose] up one nose and then she came to…She just didn’t remember anything. She said, ‘What happened? I remember washing my hands and, like, what happened?’ We said, ‘You just overdosed in this room!’ So yeah, it was wicked scary.” Self-protective measures often employed “Like I will do a very, very, very little bit of fentanyl…and if I don’t feel it, I will do that little bit plus half. I’m just not going to throw the whole thing in the cooker and then do it, no way. I just know better.” Co-use of opioids and benzodiazepines “My daughter’s mother had benzos. And when she did one bag of heroin she already had done four or five Klonopin [brand of clonazepam] and she just died. That was it. She went into a coma for the night and she was dead in the morning.” * Categories are not mutually exclusive; all respondents reported using opioids in the past 12 months and had witnessed or experienced an overdose, or both. Among 196 opioid overdose decedents whose records were reviewed, 73% were men, 50% were aged 15–34 years, and 91% were non-Hispanic white. Demographics of fentanyl overdose decedents were similar to those of the overall opioid overdose decedents (Table). Among all opioid overdose decedents 64% tested positive for fentanyl on postmortem toxicology; this proportion increased from 44% in October 2014 to 76% in March 2015 (Figure). Eighty-two percent of fentanyl deaths were suspected to involve IMF, 4% were suspected to involve prescription fentanyl, and 14% involved an unknown source of fentanyl. Thirty-six percent of fentanyl deaths had evidence of an overdose occurring within seconds to minutes after drug use, and 90% of fentanyl overdose decedents were pulseless upon emergency medical services arrival (Table). Ninety-one percent of fatal fentanyl overdoses occurred in a hotel, motel, or private residence. Only 6% of fentanyl overdose deaths had evidence of lay bystander-administered naloxone, which is available from pharmacies and harm reduction programs in Massachusetts. In addition to the limited use of naloxone by laypersons, rapid bystander response to fentanyl overdose was inhibited by lack of bystanders (18%), spatial separation of decedents from bystanders (e.g., person was in another room of the house [58%]), lack of awareness of decedent’s drug use by bystanders (24%), intoxication of bystanders who were present (12%), failure of bystanders to recognize overdose symptoms (11%), or bystander assumption that the decedent had gone to sleep (15%). Clear evidence that a bystander was unimpaired, witnessed the drug consumption, and was present during an overdose (i.e., able to respond immediately) was reported in 1% of the fentanyl overdose decedent charts. TABLE Demographic characteristics and overdose precipitating circumstances of fentanyl overdose decedents (N = 125) — Barnstable, Bristol, and Plymouth counties, Massachusetts, October 1, 2014–March 31, 2015 Characteristic No. (%) Sex Male 100 (80) Female 25 (20) Age group (yrs) 15–24 15 (12) 25–34 52 (42) 35–44 24 (19) ≥45 34 (27) Race/Ethnicity White, non-Hispanic 111 (89) Other 14 (11) Location of overdose Decedent's home 85 (68) Other private residence 22 (18) Hotel or motel 7 (6) Other 11 (9) Overdose onset, pulselessness, and bystander naloxone administration Evidence of rapid onset of overdose symptoms 45 (36) Pulseless upon emergency medical services arrival 112 (90) Evidence of bystander naloxone administration 7 (6) Barriers to bystander response No bystander present 23 (18) Decedent spatially separated from any bystander* 73 (58) Bystander unaware of decedent’s drug use 30 (24) Bystander also using drugs or alcohol 15 (12) Bystander reported symptoms of intoxication or overdose (snoring, falling asleep, or nodding), but did not realize decedent was overdosing 14 (11) Decedent was thought to have gone to sleep 19 (15) Route of drug administration† Evidence of injection 83 (66) Evidence of insufflation (snorting) 11 (9) No evidence of route of administration 26 (21) * Spatial separation defined as having a bystander nearby, either during or shortly preceding the overdose, who potentially had an opportunity to intervene and respond to the overdose, but who was not in the same room or physical space as the decedent. † Categories were not defined as mutually exclusive, but all records with evidence of injection had no evidence of insufflation, and all records with evidence of insufflation had no evidence of injection. Any evidence of route of administration was coded but not linked to specific drugs. FIGURE Percentage of opioid overdose deaths involving fentanyl, heroin/morphine (without fentanyl), and other opioids (without fentanyl, heroin/morphine) — Barnstable, Bristol, and Plymouth counties, Massachusetts, October 2014–March 2015 Alternate Text: The figure above is a bar chart showing the percentage of opioid overdose deaths involving fentanyl, heroin/morphine (without fentanyl), and other opioids (without fentanyl, heroin/morphine) in Barnstable, Bristol, and Plymouth counties, Massachusetts, October 2014–March 2015 Discussion Introduction of fentanyl into the illicit drug market has been a major contributing factor to the rapid increase in opioid overdoses in southeastern Massachusetts and reflects a growing national public health issue ( 7 ). Previous DEA reports ( 4 ) and the findings of this investigation indicate that IMF is widely available through illicit drug markets in southeastern Massachusetts, and that the majority of fentanyl linked to fatal overdoses is suspected IMF rather than diverted prescription fentanyl. Taken together, these data highlight the need to integrate fentanyl testing into standard substance use toxicology tests employed by the medical, criminal justice, and treatment communities in Massachusetts areas with high levels of fentanyl use and overdose. Evidence from over one third of medical examiner charts and reports from 75% of interview respondents demonstrated that fentanyl overdose can begin suddenly, progress to death rapidly, and manifest atypical physical symptoms. Timely administration of a sufficient naloxone dose by a trained layperson or emergency medical services responder can reverse fentanyl overdose. Although bystanders were frequently present in the general location of overdose death, timely bystander naloxone administration did not occur because bystanders did not have naloxone, were spatially separated or impaired by substance use, or failed to recognize overdose symptoms. Findings indicate that persons using fentanyl have an increased chance of surviving an overdose if directly observed by someone trained and equipped with sufficient doses of naloxone. In some countries, including Canada and Australia, overdose morbidity and mortality rates have decreased in areas near supervised injection facilities where personnel are available to observe overdose onset, if it occurs, and administer naloxone as needed ( 8 ). Because multiple doses might be required to reverse a fentanyl overdose, emergency medical services and community naloxone distribution programs might need to ensure that appropriate numbers of doses are distributed. The findings in this report are subject to at least three limitations. First, toxicology reports in medical examiner charts cannot distinguish between prescription fentanyl and IMF; therefore, categorization was completed using death scene evidence, which varied and sometimes was inconclusive. In addition, samples were not tested for emerging fentanyl analogs, such as carfentanil. Overdose deaths were also categorized broadly as involving fentanyl, heroin or morphine, or other opioids, although in many cases other drugs also contributed to the death. Atypical symptoms reported during fentanyl overdose may be attributable to other drugs or drug combinations and not fentanyl. Second, circumstances or events preceding death (e.g., rapid onset of overdose symptoms) can be inferred from death scene evidence, but absence of evidence cannot be interpreted as evidence of absence; numbers presented therefore likely underestimate the actual prevalence of circumstances. Finally, interview respondents were recruited with the help of community-based harm reduction programs in which overdose prevention education and naloxone rescue kits were offered. Thus, this sample population was potentially more informed about and experienced with fentanyl, naloxone, overdose prevention and treatment, and rescue efforts than are all persons who use illicit opioids. In addition, interview comparability is limited because not all respondents were asked uniform questions. Adaptation of harm reduction practices designed to reduce health-related consequences of unsafe drug use, including the addition of warnings about fentanyl’s characteristics and toxicity, could mitigate the fentanyl-related impact of the U.S. opioid epidemic in communities affected by fentanyl. Population-based strategies to prevent and reduce opioid use and opioid use disorders, such as expansion of access to evidence-based treatment, are likely to be effective in preventing fentanyl overdose and death. The high percentage of fatal overdoses occurring at home with no naloxone present, coupled with the rapid onset of overdose symptoms after using fentanyl through injection or insufflation, underscores the urgent need to expand initiatives to link persons at high risk for overdose (such as persons using heroin, persons with past overdoses, or persons recently released from incarceration) to harm reduction services and evidence-based treatment ( 2 , 8 ). Summary What is already known about this topic? Fentanyl has a growing presence in the illicit drug market and is involved in an increasing proportion of opioid overdose deaths. What is added by this report? Approximately two thirds of investigated opioid overdose deaths in southeastern Massachusetts during October 1, 2014–March 31, 2015 involved fentanyl, a majority of which was suspected illicitly manufactured fentanyl (IMF), reported to be widely available in the illicit drug market. Fentanyl overdose can progress rapidly, and a majority of decedents were physically separated from bystanders. Naloxone can reverse fentanyl overdose if administered in sufficient dosage immediately upon recognition of overdose symptoms. What are the implications for public health practice? A comprehensive public health response is needed to address overdoses related to IMF. First, fentanyl should be included on standard toxicology screens to facilitate early identification. Second, existing harm reduction strategies to identify likely fentanyl exposure should be adapted, such as training for bystanders that includes direct observation of anyone injecting or insufflating illicit opioids, ensuring that trained bystanders are equipped with sufficient doses of naloxone, expanding layperson training, and providing access to naloxone. Third, access and linkages to medication for opioid use disorders need to be enhanced in fentanyl-affected areas.
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            Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective.

            The treatment of chronic pain, therapeutic opioid use and abuse, and the nonmedical use of prescription drugs have been topics of intense focus and debate. After the liberalization of laws governing opioid prescribing for the treatment of chronic non-cancer pain by state medical boards in the late 1990s, and with the introduction of new pain management standards implemented by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 2000, opioids, in general, and the most potent forms of opioids including Schedule II drugs, in particular, have dramatically increased. Despite the escalating use and abuse of therapeutic opioids, nearly 15 to 20 years later the scientific evidence for the effectiveness of opioids for chronic non-cancer pain remains unclear. Concerns continue regarding efficacy; problematic physiologic effects such as hyperalgesia, hypogonadism and sexual dysfunction; and adverse side effects - especially the potential for misuse and abuse - and the increase in opioid-related deaths. Americans, constituting only 4.6% of the world's population, have been consuming 80% of the global opioid supply, and 99% of the global hydrocodone supply, as well as two-thirds of the world's illegal drugs. Retail sales of commonly used opioid medications (including methadone, oxycodone, fentanyl base, hydromorphone, hydrocodone, morphine, meperidine, and codeine) have increased from a total of 50.7 million grams in 1997 to 126.5 million grams in 2007. This is an overall increase of 149% with increases ranging from 222% for morphine, 280% for hydrocodone, 319% for hydromorphone, 525% for fentanyl base, 866% for oxycodone, to 1,293% for methadone. Average sales of opioids per person have increased from 74 milligrams in 1997 to 369 milligrams in 2007, a 402% increase. Surveys of nonprescription drug abuse, emergency department visits for prescription controlled drugs, unintentional deaths due to prescription controlled substances, therapeutic use of opioids, and opioid abuse have been steadily rising. This manuscript provides an updated 10-year perspective on therapeutic use, abuse, and non-medical use of opioids and their consequences. 
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              Cohort Study of the Impact of High-dose Opioid Analgesics on Overdose Mortality

              Previous studies examining opioid dose and overdose risk provide limited granularity by milligram strength and instead rely on thresholds. We quantify dose-dependent overdose mortality over a large spectrum of clinically common doses. We also examine the contributions of benzodiazepines and extended release opioid formulations to mortality.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2018
                11 October 2018
                : 11
                : 2295-2299
                Affiliations
                [1 ]Department of Pharmacy, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA
                [2 ]Department of Pharmacy, Albany Stratton VA Medical Center, Albany, NY, USA
                [3 ]Remitigate, LLC, Delmar, NY, USA
                [4 ]Albany College of Pharmacy and Health Sciences, Albany, NY, USA
                [5 ]Western New England University College of Pharmacy, Springfield, MA, USA
                [6 ]Research and Network Development, Boston Pain Care, Waltham, MA, USA, michael.schatman@ 123456tufts.edu
                [7 ]Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA, michael.schatman@ 123456tufts.edu
                Author notes
                Correspondence: Micahel E Schatman, Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA, Email michael.schatman@ 123456tufts.edu
                Article
                jpr-11-2295
                10.2147/JPR.S172335
                6188013
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