First Action Taken Agains Opioid Epidemic

  • Journal List
  • Hurting Ther
  • five.7(1); 2018 Jun
  • PMC5993682

Pain Ther. 2018 Jun; 7(one): 13–21.

A Brief History of the Opioid Epidemic and Strategies for Pain Medicine

Mark R. Jones

oneBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA U.s.

Omar Viswanath

1Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, MA USA

Jacquelin Peck

2Johns Hopkins Medical Center, All Children'south Infirmary, St. Petersburg, FL USA

Alan D. Kaye

3Louisiana State Academy Health Science Heart, New Orleans, LA U.s.

Jatinder S. Gill

1Beth Israel Deaconess Medical Heart, Harvard Medical School, Boston, MA The states

Thomas T. Simopoulos

1Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA United states

Abstract

The opioid epidemic has resulted from myriad causes and will not be solved by any elementary solution. Consequent to a staggering increase in opioid-related deaths in the Us, various governmental inputs and stakeholder strategies have been proposed and implemented with varying success. This article summarizes the history of opioid use and explores the causes for the nowadays day epidemic. Recent trends in opioid-related data demonstrate an almost fourfold increase in overdose deaths from 1999 to 2008. Tragically, opioids claimed over 64,000 lives just final twelvemonth. Some solutions have undergone legislation, including the limitation of numbers of opioids postsurgery, as well as growing national prevalence of enhanced recovery after surgery protocols which focus on reduced postoperative opioid consumption and shortened hospital stays. Stricter prescribing practices and prescription monitoring programs accept been instituted in the recent past. Improvement in abuse deterrent strategies which is a major focus of the Food and Drug Administration (FDA) for all opioid preparations will likely play an of import function past increasing the prophylactic of these medications. Future potential strategies such equally boosted legislative policies, public awareness, and md instruction are also detailed in this review.

Keywords: Abuse deterrent formulations, Enhanced recovery after surgery, Non-opioid pain treatments, Opioid epidemic, Overdose

Introduction

As of Oct xvi, 2017, the Us Government declared the opioid epidemic a public wellness emergency. The medical community, and particularly hurting medicine practitioners, have been active participants and fully aware of the development of the current state. Prescription drug monitoring programs (PDMPs) and the National All Schedules Prescription Electronic Reporting Human action (NASPER) have effectively contributed to the reduction in opioid prescriptions past viii% and prescription opioid overdose death rates by 12% [1]. Despite these substantial reductions in opioid prescriptions in the USA, deaths past opioid overdose go on to escalate at alarming rates: 64,000 people died from drug overdoses in 2016; over 42,000 of those were opioid deaths [2, 3]. This represents a 20% increase from the total of 52,000 drug overdose fatalities in 2015. Overdoses related to illegally manufactured fentanyl represent the greatest contribution to the increase, accounting for twenty,000 deaths in total; heroin accounted for fifteen,000 deaths; and prescription drugs for less than 15,000. Figures1 and two nowadays the rates of opioid prescriptions and the rate of opioid-related deaths.

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Annual opioid prescribing rates in the USA, 2006–2015; prescribing rates past number of days' supply; boilerplate daily morphine milligram equivalent (MME) per prescription; and average number of days' supply per prescription [four]

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Number of opioid overdose deaths by category, 1999–2016. Opioid-related deaths increase dramatically in 2016 [5]

Many parties are responsible for the present mean solar day epidemic. Well-intentioned efforts by multiple industries, medical specialty associations, and governmental oversight organizations accept resulted in our electric current climate. This manuscript will describe a brief overview of the history of opioid therapy as information technology relates to hurting and forecast in detail the ramifications for the exercise of pain medicine as an contained and increasingly vital specialty.

Compliance with Ethics Guidelines

This commodity is based on previously conducted studies and does not incorporate whatever studies with human being participants or animals performed by any of the authors.

Brief Timeline of Opioid Analgesics

Although a detailed description of pain pathways and relevant medical interventions is across the telescopic of this paper, it suffices to say that much of our understanding of hurting pathophysiology is recent, and that the field remains in infancy but rapidly evolving. Before 1800, clinicians regarded pain as an existential miracle, a upshot of aging [6]. At that place was no regulation on the use of cocaine and opioids, resulting in widespread marketing and prescribing for many ailments ranging from diarrhea to toothache [7]. The Harrison Narcotic Command Act of 1914, passed in response to the sudden emergence of street heroin abuse as well every bit iatrogenic morphine dependence, influenced both physician and patient alike to avoid opiates [eight]. Patients with unexplained pain in the 1920s were regarded as deluded, malingering, or abusers, and cancer patients through the 1950s were encouraged to wean themselves off opioids until their lives "could be measured in weeks" [ix].

This attitude persisted into the latter half of the twentieth century; a general world-wide "opiophobia" is thoroughly detailed in contemporary literature. Morgan in 1985 and Zenz and Willweber-Strumpf in 1992 both describe a state of under-reliance of opioid analgesics and a resultant nether-handling of pain in Europe and N America [10, eleven]. Several developments over this era served to increase awareness of pain under-handling. A 1973 manuscript from Marks and Sachar in the Annals of Internal Medicine described a failure to treat patients in severe pain with adequate doses of opioid analgesics [12]. Two decades subsequently, Max [13] decried the same failure, invoking the conventional wisdom of the day that "therapeutic use of opiate analgesics rarely results in addiction." This widespread belief was based upon ii minor retrospective publications from the 1980s: the kickoff, published as a one paragraph letter to the editor without detailing whatever scientific rigor, described low (0.03%) addiction rates for inpatients receiving opioids for acute pain; the second, a retrospective review of 38 patients, demonstrated that only ii of 38 patients with chronic hurting developed misuse or abuse issues when receiving opioids [14, xv]. The scientific background for the use of opioids for non-malignant pain was therefore non based upon whatsoever demonstrable outcomes or safety studies.

The Earth Health Organization addressed the under-treatment of postoperative and cancer pain in 1986 with their Cancer Pain Monograph [sixteen]. A rapid improvement in the handling of cancer pain soon unfurled in many countries, though not entirely, as many countries even today suffer from poor admission to opioids [17]. This further prompted a number of publications in the 1990s that questioned the land of hurting nether-treatment. Notably, Ronald Melzack in 1990 [xviii] published an article in Scientific American that questioned why opioids were reserved solely for cancer pain and avoided entirely in chronic pain states. The newfound interest bore misconceptions, drawn largely by cancer hurting specialists lacking expertise on other chronic, non-cancer pain, that equated the etiologies of malignant and not-malignant hurting [xv]. This dangerous conflation disregards the circuitous biopsychosocial phenomena that is chronic pain, and despite many cautions to this effect, opioids grew into the master modality of chronic not-cancer pain treatment in the Usa [19].

Alongside this opioid evolution, the American Pain Club launched their influential "pain as the fifth vital sign" campaign in 1995, with intent to encourage proper, standardized evaluation and treatment of pain symptoms [20]. The Veteran's Health Administration lent support to the campaign with their 1999 adoption of pain as the fifth vital sign initiative [21].

Solidifying the national response to the aforementioned efforts, the Joint Committee (TJC) published standards for pain management in 2000, emphasizing the need for organizations to conduct quantitative assessments of hurting equally recommended by the Establish of Medicine [22]. The Federation of State Medical Boards and the Drug Enforcement Bureau also issued statements promising less regulatory scrutiny over opioid prescribers, thereby assuaging medico reluctance to prescribe more than liberal amounts of opioid analgesics [23].

The rapid institution of strict standards for pain management in infirmary systems culminated in several unintended consequences. Physicians were now mandated to provide adequate pain control by the TJC, resulting in a heavy reliance on opioid medications. The fear among infirmary administration was that if new TJC benchmarks were not met, then they were unlikely to receive federal healthcare funds. Indeed, hospitals that invested more readily in opioid therapy generally received amend satisfaction rates amidst their patient population [24]. Pharmaceutical companies heavily pushed the utilise of opioids every bit a humane treatment option, often using paid md consultants to expound on the safety and benefits of opioids use. Non prescribing opioids for a patient with pain risked being labeled as inhumane, frequently even to the extent of litigation for the under-treatment of pain [25]. Trainees in pain medicine as well as other medical specialties were taught to rely more on opioids for hurting treatment. Concurrently, pharmaceutical companies introduced new formulations, such as extended release oxycodone (OxyContin), which were frequently prescribed because of a presumed lower likelihood of abuse, while in reality were heavily driveling. From 1997 to 2002, OxyContin prescriptions increased from 670,000 to vi.2 million [26]. Overall opioid consumption continued to climb throughout the 2000s in the USA, ascension from 46,946 kg consumed in the year 2000 to a peak of 165,525 kg in 2012 [27].

The initial response was favorable, and the push for better pain control appeared successful. 1 study plant that the mean consumption of opiates per patient in the postanesthesia intendance unit of measurement (PACU) increased from 40.4 mg of morphine equivalent to 46.6 mg from 2000 to 2002 with no associated increase in length of stay, naloxone apply, or nausea and vomiting [28]. Nonetheless, concerns soon began to surface regarding overzealous opioid handling. One written report found that the incidence of opioid oversedation more than doubled from 11.0 to 24.five per 100,000 inpatient hospital days with the implementation of a new standardized, numerical pain treatment algorithm [29]. The Institute for Safety Medication Practices began to found a link between overaggressive hurting management and substantial increases in the incidence of oversedation and associated fatal respiratory low. The culture change, driven past intent to ensure access to hurting relief, had opened the floodgates to the current opioid climate. In just the past 15 years, there has been a proportionate quadrupling of prescription opioid sales and mortality in both men and women based on National Vital Statistics System mortality statistics from the Centers for Affliction Command and Prevention [30]. Perplexingly, in improver to the increasing mortality, no study to this date has established level I evidence for the long-term rubber and efficacy of opioid therapy in reducing chronic pain intensity and improving part. Instead, numerous other ills arising from opioid medication, such every bit hyperalgesia, increasing disability, and a host of other formidable bug, including endocrine and psychological co-morbidities, have emerged in relation to chronic opioid use.

It must be noted that pharmaceutical companies contributed significantly to the rise of the opioid epidemic, receiving considerable reprimands as a outcome. In 2007, every bit the opioid epidemic began to inflict profound damage, Purdue Pharma pleaded guilty to federal charges related to the misbranding of OxyContin. Purdue agreed to pay a full of $634.five million to resolve Justice Section investigations, every bit well as a $nineteen.5 million settlement to 26 states and the Commune of Columbia [31]. Allegations charge Purdue of intentionally downplaying the risk of addiction posed by OxyContin and misleading both physicians and the healthcare industry every bit a whole by overstating the benefits of opioids for chronic pain. At the time of this publication, at least fourteen states take submitted lawsuits against the privately held Purdue, and the company has announced that it will cut its sales strength in half and stop promoting opioids to physicians in a stark reversal of policy from recent decades.

Reaction to Opioid Epidemic

In response to the current epidemic, changes in focus to the development of new abuse deterrent opioid formulations at the The states Food and Drug Assistants (FDA) too as drafting of new public standards for pain treatment were created at TJC in 2017 [32]. Efforts to develop and provide admission to medications intended to treat opioid dependence had begun some time earlier, however. The Drug Addiction Treatment Human action of 2000 (Information 2000) immune physicians with a waiver from the Center for Substance Abuse and Mental Health Services Administration to prescribe schedule 3, IV, and Five medications to treat opioid dependence. The FDA approval in 2002 of buprenorphine and buprenorphine/naloxone formulations allowed specially trained chief care physicians (PCPs) access to these medications. The 2006 Reauthorization Human action increased the allowable maximum number of buprenorphine patients per PCP from thirty to 100 patients. These efforts greatly enhanced access to treatment for opioid-dependent patients.

In response to the opioid epidemic, FDA public policy changes were announced in February 2016. Among these new positions were a re-examination of the risk–do good epitome for opioids with strict emphasis on the big public wellness ramifications; expanded access to and encouraged evolution of abuse-deterrent opioid formulations; proficient advisory committee assembly prior to new applications for opioids lacking corruption-deterrent properties; improved admission to naloxone and other handling options for opioid use disorder; inclusion of rubber information and warnings on immediate-release (IR) opioid labeling; and support for culling hurting management modalities. The various modified opioids released over the past 20 years, such as tamper-resistant training, have had differing levels of success, and are collectively referred to as Adventure Evaluation and Mitigation Strategies (REMS); these include Targiniq® (oxycodone and naloxone), Suboxone® (buprenorphine/naloxone), reformulated OxyContin® ER (extended release), among others [33–37]. Before long, fewer than one dozen FDA-approved Abuse-Deterrent Formulations (ADFs) exist, but further development and improvements are ongoing [38].

The January 2017 release of new TJC standards continued the focus on appropriate and effective direction of pain, including the recommended inclusion of psychosocial risk factors that may bear upon self-reporting pain in any pain assessment; set realistic goals when developing handling plans with patients; emphasize impairment of physical part during pain assessment; emphasize diligent monitoring of opioid prescribing patterns; and promote use of non-pharmacologic pain treatments. In add-on, the draft suggests changes to pain management designed to preclude diversion, such as identification of loftier-risk patients, readily available equipment for monitoring loftier-chance patients, piece of cake clinician access to prescription monitoring programs databases, and educating patients and families on the safe utilize, storage, and disposal of opioid medications. Changes have also been put in place at the land level, including providing more limited and standardized doses of opioids for acute pain management and required standing education for all clinicians who prescribe opioid medications. In this regard, a joint Food and Drug Administration Advisory in 2016 voted unanimously to require continuing pedagogy for all opioid-prescribing physicians, regardless of specialty, and soon remains a common element of quality improvement projects [39].

Implications for Pain Medicine

With the evolution and manifestation of the current opioid epidemic, opioid prescription and employ dependence have gained national attention at the forefront of healthcare politics. Related research and publications in peer-reviewed journals have grown exponentially, and authorities policy has adapted to run into growing concerns surrounding opioids, including greater scrutiny and laws limiting opioid doses during the outset week of acute hurting management [40]. Maintaining adequate pain control is still a priority, merely efforts to titrate opioid use and to increase the use of multimodal pain regimens and ADFs are underway. Enhanced recovery later surgery techniques focus on regimens that include nerve blocks, non-steroidals, gabapentinoids, acetaminophen, and ketamine to decrease postoperative opioid consumption and reduce hospital stays.

As stated earlier, the conflation of cancer hurting with chronic not-cancerous pain ignored the biopsychosocial complexities underlying the latter, leaving a multidisciplinary approach to the wayside in favor of an overreliance on opioids. Pain direction as a specialty will benefit from reinstitution of such multidisciplinary involvement, with emphasis on multimodal analgesia, interventional therapies, and outcomes stressing improvement in concrete function.

At that place is also a growing focus on preventing opioid use disorder (OUD) and on offering affected individuals accessible and effective treatment. US government policy reflects these changes and both the Affordable Care Act and the Mental Health Parity and Addiction Disinterestedness Act were major steps forward in treating opioid addiction. The Affordable Care Act, which was signed into constabulary in 2010, with major provisions coming into outcome past 2014, dramatically reduced the number of uninsured patients within the USA by 2016 and ensured access to essential health benefits including substance apply disorder services and rehabilitative services [41]. This gave opioid-dependent individuals more accessible and affordable routes to handling. Similarly, the Mental Health Parity and Addictions Equity Act, which took effect in 2010, prevented insurers from placing greater restrictions on mental wellness and substance abuse disorder treatment benefits than benefits for medical and surgical care [42]. Both initiatives reduce barriers to effective handling.

Modern culture surrounding opioid use disorder has also changed. Recent studies confirm that treatment for OUD is well-nigh effective when comprised of multimodal interventions that are both pharmacological and psychosocial [43]. Therefore, peer-led back up groups, community-wide prevention strategies, and stigma-reducing initiatives continue to develop and to demonstrate varying degrees of success in response to the opioid epidemic [44, 45]. In this regard, one recent publication as well addressed the role of local government in the opioid crunch and stressed the importance of local public wellness coalitions aimed at preventing overdoses and promoting handling options, likewise as city-wide anti-stigma pedagogy [45].

Potential Strategies

Governmental and regulatory agencies' new legislation necessitates a shift in tactics by medical specialty associations in order to comply with and respond to the new perspective. It is crucial that the response to the opioid epidemic does not eradicate the significant strides made over the by half century in our understanding of hurting and the enrichment of the therapeutic arsenal at our disposal. This is reflected by the 2010 Declaration of Montreal released by the International Association for the Study of Pain, wherein they maintain and reemphasize the ideal that the relief of suffering and pain is a moral duty of physicians, and that access to hurting treatment is a fundamental human right [46]. Following this lite, in guild to go on to adjourn opioid corruption and reduce opioid deaths while maintaining adequate access to pain relief, the American Society of Interventional Pain Physicians (ASIPP) has issued recommendations focused on two main arenas: more effective legislative efforts while maintaining appropriate access, and the promotion of not-opioid modalities including interventional techniques. These recommendations are comprised in three separate tiers.

Tier ane stresses aggressive public pedagogy to explicitly address the dangers of illicit drugs (heroin and fentanyl); the adverse consequences of opioid abuse along with the increased take a chance of opioids combined with benzodiazepines; mandatory 4 h of continuing physician education per year for all prescribers of any corporeality of opioid or benzodiazepine; and mandatory patient didactics associated with the starting time prescription of any corporeality of opioid. According to a contempo survey published in the New England Journal of Medicine, a significant percent of the public blame the opioid epidemic on doctors who inappropriately prescribe medication (46%), with simply 28% allocating blame to people who illegally sell prescription pain killers, and 13% blaming pharmaceutical companies [47]. In this aforementioned survey, the public believes public awareness and education programs are constructive and should be continued.

ASIPP's tier 2 recommendations emphasize ease of access along with lower or no copayments for directed modalities based on non-opioid pain therapy including physical therapy and interventional techniques. Interestingly, show demonstrates a directly correlation between the decline in the utilization of interventional techniques since 2010 secondary to decreasing reimbursements and the ultimate escalation in opioid deaths over the same catamenia [48]. Until prior authorizations for non-opioid treatment modalities are eliminated, and prior authorizations for opioid treatments increased, the arsenal of non-opioid therapies available to pain medicine clinicians volition be limited, and the reliance on opioids will continue. Another strategy emphasized in tier 2 is the expansion of low-threshold access to buprenorphine for opioid use disorder, which, after implementation in French republic, effectively decreased opioid overdose deaths by 79% over a 6-year period [49]. Lastly, tier 2 recommendations include the establishment of prescription drug monitoring programs (PDMP) that are capable of interstate communication, as well as mandatory provider review of PDMP data prior to prescribing.

The third tier of ASIPP's approach focuses on buprenorphine and methadone. ASIPP recommends that buprenorphine be changed to a schedule II substance, and be fabricated mandatorily available for chronic pain direction in add-on to medication-assisted treatment. Finally, ASIPP recommends in tier 3 that methadone be removed from the formulary, every bit information technology is responsible for over 3000 deaths per year despite comprising in total only 1% of prescribed opioids.

Conclusion

The opioid epidemic has arisen in part from a complex history of well-intentioned efforts past multiple industries to balance acceptable and vital treatment of pain against the misuse and corruption of opioid medications. The presumption that opioids are safe and effective for chronic pain over the previous decade led to the overreliance on opioids and a pregnant reduction in the number of multidisciplinary pain centers across the USA that were proven effective for this status. A reduction in reimbursement for such multispecialty centers further shifted management in the direction of pharmacotherapy. Yet, the electric current state of rampant abuse and consequential fatal overdoses afflicting the United states is unacceptable and deserving of a profound response. At that place is a clear demand to end the focus on blaming responsible parties and shift to implementing solutions. To that end, governmental regulatory agencies and specialty-specific physician associations have released multiple regulatory measures and societal recommendations that together have contributed to a decrease in the corporeality of opioid prescriptions over recent years. Concerted efforts from multiple disciplines, including physicians, legislators, pharmaceutical companies, educators, and the general public are required to ensure that the epidemic does not keep into the future.

Acknowledgements

Funding

No funding or sponsorship was received for this study or publication of this article.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and accept given their approval for this version to exist published.

Disclosures

Mark R. Jones, Omar Viswanath, Jacquelin Peck, Jatinder Due south. Gill, and Thomas T. Simopoulos have nothing to disembalm. Alan D. Kaye is on the Speakers Bureau for Depomed, Inc. and Merck, and has served on the FDA Advisory Board on Analgesics, Anesthetics, and Addiction Medicine since 2012.

Compliance with Ethics Guidelines

This commodity is based on previously conducted studies and does not comprise any studies with human participants or animals performed past any of the authors.

Open up Access

This commodity is distributed nether the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided yous give appropriate credit to the original writer(s) and the source, provide a link to the Creative Commons license, and bespeak if changes were made.

Footnotes

Enhanced digital features

To view enhanced digital features for this article go to 10.6084/m9.figshare.6133172.

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5993682/

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