Pain Management and the Opioid Epidemic Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017) / Chapter Skim
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5 Evidence on Strategies for Addressing the Opioid Epidemic
5 Evidence on Strategies for Addressing the Opioid Epidemic
Pages 267-358
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From page 267... ...
Likewise, the continued progression of still more people from prescription opioid use to OUD will demand sustained and coordinated effort to establish and implement the scientifically grounded policies and clinical practices necessary to reshape prescribing practices and reduce the occurrence of new cases of prescription opioid-induced OUD.1 What should be done to contain the opioid epidemic and to prevent new cases of iatrogenic addiction and associated overdose, death, and other harms? The purpose of this chapter is to review available evidence on strategies that have been used to address the problems of opioid misuse, OUD, 1 Vigilance will also be needed to reduce the risk of similar problems in the future with other classes of medications for which there exists demand for clinical uses other than the indicated conditions and/or active black markets for their resale.
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the need for a systems approach, including the importance of recognizing the potential effects that interventions focused on misuse of prescription opioids have on misuse of opioids more generally. Next the chapter reviews the evidence on the effectiveness of strategies for addressing the opioid epidemic in four categories: (1)
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In the real world, for example, the restricted opioid prescription policy might more likely be applied to individuals visiting providers in urban health care settings who also received other interventions to reduce the risk of addiction. As a result, a direct comparison of the outcome distribution between those who received each strategy would be confounded by the concomitant interventions.
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Indeed, some interventions that successfully reduced diversion of prescription opioids might, at least in theory, initially increase rather than decrease the number of overdose deaths, even if they reduced deaths in the long run, as the result of an initial surge in deaths among people already addicted to prescription opioids who turned to black market substitutes, whose potency is more variable. Furthermore,
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A typical clinical trajectory that policy changes would like to prevent starts with medically appropriate use of prescription opioids, escalates to misuse and then to OUD, and then evolves to trading down to cheaper black market opioids before manifesting in overdose. Thus, a leaky prescription drug system increases the flow of people into the state of having OUD.
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years, with modest flows out of that state through overdose death, death from other causes, or permanent cessation of use.3 The number of overdoses per year might be roughly proportional to the number of people who currently had an active OUD, but this number would not be proportional to the current inflow of new people developing OUD, which is what many interventions aimed at controlling the misuse of prescription opioids would affect most directly. Those interventions would not instantly change the prevalence of OUD and hence would generally not have an immediate effect on overdose.
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In addition, as shown in Chapter 4, the prescription opioid epidemic is interwoven with the illegal drug market. Therefore, this chapter considers policy options for reducing OUD, mortality due to opioid overdose, and other opioid-related harms among people who have ever used prescription opioids, rather than focusing exclusively on options for reducing misuse of or overdoses from prescription opioids alone.
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. As noted earlier and discussed in greater depth in Chapter 4, in the case of the opioid epidemic, one common pathway to death over the past 20 years has been becoming addicted to prescription opioids, no longer being able to sustain that habit financially, and so trading down to cheaper black market opioids before dying of an overdose or suicide.
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That in turn means there is no practical way to count precisely how many overdose deaths are due to prescription opioids even in the narrow sense that the proximate cause of death was a dose that had been prescribed. It is worth noting that black market fentanyl is a relatively recent phenomenon.
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In sum, when evaluating past policies and estimating the effects of future interventions, it is necessary to use a comprehensive approach that takes full account of the interactions between prescription and black market opioids. Ideally, this approach could take the form of a quantitative model,
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Sometimes they are seen, mistakenly, to be in tension with one another, as in the example that making naloxone available to prevent a fatal overdose (harm reduction) can counteract policies aiming to discourage opioid misuse.
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278 PAIN MANAGEMENT AND THE OPIOID EPIDEMIC BOX 5-1 Strategies for Addressing the Opioid Epidemic Restricting Supply and Reducing Demand Regulating the approved product (e.g., abuse-deterrent formulations) Restricting lawful access • Scheduling • Preventing and penalizing diversion • Drug take-back programs • Other state and local policies restricting access Influencing prescribing practices • Provider education • Prescribing guidelines • Electronic medical records and decision support • Insurer policies • Prescription drug monitoring programs Patient and public education Increasing access to and utilization of medical treatment for opioid use disorder Reducing Harmful Consequences Use of naloxone to reverse overdose Reducing disease transmission • Syringe exchange • Supervised injection facilities • Drug checking • Behavioral interventions these strategies would still leave a huge reservoir of people misusing and addicted to opioids for years if not decades to come.
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This section reviews such supply-side strategies, including regulation of legal access to opioids for legally approved uses. The next section addresses legal regulations and professional policies aimed at reducing lawful access by discouraging unnecessary opioid prescribing or promoting safe prescribing practices.
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An industry-sponsored review by Michna and colleagues (2014) found that, relative to placebo, ADFs and non-ADFs were comparably effective and safe for individual patients with noncancer pain.
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examined the harms associated with reformulated OxyContin compared with other comparator prescription opioids, reporting a noticeable relative decrease for OxyContin, although this study did not specifically examine collateral outcomes such as potential transition to heroin and related harms. A recent state-by-state analysis suggests that the introduction of ADF OxyContin in 2010 resulted in reduced OxyContin misuse, but with a trade-off of increased heroinrelated deaths and evidence of an overall trend of increased opioid overdose deaths (Alpert et al., 2017)
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Such perverse effects do not necessarily have the potential to outweigh the beneficial effects of ADFs, but that they are readily imagined does underscore the point that no clinical trial finding an ADF to be safe and effective when the unit of analysis is the individual patient necessarily indicates that the ADF will have a net positive effect on public health. In summary, although ADFs of opioids would be expected to reduce some opioid-related harms, it is necessary to consider whether these benefits are offset by their potential effect on movement to illicit markets (either for diverted non-ADF prescription opioids or for illegal drugs such as heroin)
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This section reviews evidence regarding the effects of the federal and state controlled substances acts and their enforcement on access to approved drugs (i.e., in deterring diversion) and, ultimately, on use (either legal or illegal)
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, for example, document that among emergency department patients in one academic tertiary hospital who received a pain-related prescription, the proportion receiving a prescription for hydrocodone-containing products fell from 58.1 to 13.2 percent following the rescheduling. Seago and colleagues (2016)
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Michigan ended nonprescription sales of the drug in April 1964, whereupon arrests collapsed, falling to 10 by 1965. Restrictions on precursor and essential chemicals A related literature explores the effect of adding legal restrictions on precursor and essential chemicals used in the production of controlled substances.
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The portion of this diversion category that is more likely to attract the attention of federal law enforcement is that which involves the knowing misbehavior of DEA registrants, such as with so-called pill mills. Some of these actions are civil, not criminal.
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Drug Take-Back Programs The DEA, among other agencies and organizations, also tries to reduce the supply of prescription opioids by facilitating the return of unused medications through drug take-back programs. Typically, these are ad hoc or occasional events that allow individuals with unused medications to bring them in to be disposed of properly.
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On the other hand, it is important to note that asking whether takeback programs are an effective way to ameliorate problems with prescription opioids is a very narrow framing. Opioids are one of many categories of medications, and the literature is concerned as much with environmental harms from improper disposal as with harms from nonmedical use.9 Despite the effort invested in occasional take-back programs, proper disposal of unused medications is relatively rare in the United States (Glassmeyer et al., 2009; Law et al., 2015; Maeng et al., 2016)
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It is also important to note that many unused medications are in institutions, such as nursing homes, so ensuring that take-back programs are available to them, not just individual consumers, is important. Ironically, both environmental and drug control laws make implementing convenient drug take-back programs challenging in the United States (Glassmeyer, 2009)
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Historically, an even greater problem was a requirement of the CSA that scheduled drugs be under the control of law enforcement. Thus, a pharmacy could run afoul of the CSA if it allowed consumers to bring back opioids at any time unless law enforcement personnel were present (Glassmeyer et al., 2009)
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Unfortunately, they conclude that the available empirical studies are generally of low quality, and that the outcomes studied are often intermediate, such as prescribing practices, and not final, such as overdose. The largest number of studies uncovered pertained to prescription drug monitoring programs (PDMPs)
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Schedule II–IV controlled substances.11 A PDMP was implemented about 1 year later. The law enforcement component ("Operation Pill Nation")
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Reduced prescribing can affect demand in two ways: first, by reducing patients' reliance on opioids to manage pain by satisfying their needs through other forms of pain management; and second, by reducing the number of patients or others who develop OUD and increasing the incentive for treatment among patients with OUD. This section describes a range of formal and informal policies, interventions, and tools designed to shape, guide, and regulate the prescribing practices of physicians and other health care professionals (the gatekeepers)
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Moreover, no single entity or organization has overall jurisdiction for the development of pain management guidelines, clinical pain competencies, or opioid prescribing practices. What exists appears to be a group of loosely aligned efforts sponsored by federal, state, and local agencies surrounded by professional organizations and private industry influences.
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As discussed in Chapter 3, NIH support for research and educational aspects of pain management is disproportionately small relative to, for example, HIV research. However, in the face of this disparity in resources to support the development of advanced pain care and address the opioid epidemic, small but determined efforts exist within NIH in support of pain research and education.
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. In the past, the limited hours dedicated to pain management education in medical schools have been restricted to a series of didactic lectures given in the first year.
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Danovic has a history of chronic low back pain that provides multiple opportunities to develop longitudinal interdisciplinary links for his pain management throughout the subsequent 4 years of training and to integrate aspects of other pain management learning. Additional curriculum advances include the Bridges program, based on "inquiry" (i.e., posing questions or scenarios to students as opposed to presenting facts)
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. In the context of pain management and opioid prescribing practices, this constellation of state-level oversight represents both a powerful tool to assist physicians in providing safe and effective care and a potential source of variability in the broader guidance to physicians across the country.
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. Opioids and Acute Pain Management Acute pain is experienced commonly after surgical or dental procedures, traumatic injuries, and some normally transient medical conditions (e.g., acute low back pain)
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. Opioids and Pain Management in the Context of Cancer and End of Life The use of opioids for the treatment of pain in the context of cancer and end of life is broadly supported by outcome studies.
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It is unclear what role opioids should play in the management of persistent pain after successful cancer treatment that might be due to surgery, chemotherapy, radiation, or other related causes. Opioids and Pain Management in the Context of Chronic Pain The controversial nature of the practice of using opioids to treat chronic pain, as well as growing recognition of its adverse consequences for both individual patients and society, has prompted the development of numerous prescribing guidelines.
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. With respect to other guidelines for chronic pain management that have been in the field longer than the CDC guideline, researchers have found modest improvement in practice behaviors, such as use of urine
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10. hen prescribing opioids for chronic pain, clinicians should use urine W drug testing before starting opioid therapy and consider urine drug test ing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
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A brief review of three key CDC topic areas across the Webbased resources of five SMBs (California, Florida, Kentucky, Ohio, and Washington) on pain management and opioid prescribing practice reveals examples of content variability: • Determining when to initiate or continue opioid treatment -- California's guidance on initiation of opioid therapy for chronic pain references carefully defined, 90-day opioid trials (MBC, 2014)
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Unfortunately, in some cases, SMB guidance for opioid pain management can be quite limited, describing only the statutory obligations of physicians prescribing controlled substances for pain, although reference also may be made to the CDC guideline (FBM, 2010; KBML, 2003)
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. Another study demonstrated that the inclusion of electronic alerts for the presence of opioid-use care plans within an EMR system may reduce opioid prescribing by emergency departments for high-frequency emergency department patients (Rathlev et al., 2016)
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Insurer Policies for Pain Management Insurer policies have a large and logical impact on health care delivery through their considerable financial leverage with respect to covering and reimbursing for specific clinical services or restricting access to others. In pain management, for example, a policy may or may not require specified indications before reimbursement for prescription opioids is authorized; in contrast, other policies may have more stringent requirements for authorization of nonopioid pain therapies and/or inadequate reimbursement structures.
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. In part in response to the growing opioid epidemic, some insurers and state Medicaid agencies are working to expand access to nonopioid pain management services for common clinical indications, such as back
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The judicious deployment of insurer policies related to opioid prescribing, outlined above, would logically benefit from a commensurate increase in coverage of and access to nonopioid pain management. This broader approach to pain management is consistent with the guidelines of the CDC (discussed earlier in this chapter)
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. A contextual review conducted to support development of the CDC's Guideline for Prescribing Opioids for Chronic Pain concluded that there is indirect evidence for the utility of PDMP data for identifying indicators of risky opioid-taking behaviors and prescribing practices (Dowell et al., 2016)
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EVIDENCE ON STRATEGIES FOR ADDRESSING THE OPIOID EPIDEMIC 311 TABLE 5-1 States Authorizing Use of PDMP Data, by Selected Professions (as of May 2016) Medicare, Medicaid, State County Health Insurance Coroners, Programs, and/ Medical or Health Care Examiners, Payment/Benefit Mental Health/ Worker's and/or State Providers or Substance Use Compensation State Toxicologists Insurers Professionals Specialists Alabama X X Alaska X X X X Arizona X X X Arkansas X California Colorado X X Connecticut X X Delaware X X X District of Columbia X X X Florida X X Georgia X Hawaii X X X Idaho X X Illinois X Indiana X X X Iowa Kansas X X X Kentucky X X Louisiana X Maine X X Maryland X X X Massachusetts X X Michigan X Minnesota X X X Mississippi X X Missouri NA NA NA NA Montana X X X Nebraska Nevada X New Hampshire X X continued
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. Furthermore, the guideline states that PDMP data should be reviewed "when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months" (Dowell et al., 2016, p.
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State program administrators reported that this effort FIGURE 5-2 Unsolicited reporting of prescription drug monitoring program (PDMP) data to prescribers, dispensers, licensing boards, and law enforcement (as of May 2016)
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As noted above, states also utilize PDMP data to address at-risk prescribing through use of such tools as prescriber report cards and reports to licensing boards and law enforcement. Data on how these reports impact prescribing practices are currently limited, however.
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This finding was significant after controlling for declines in mortality associated with the introduction, before implementation of the PDMP, of tamper-resistant oxycodone hydrochloride (HCL) controlled-release tablets to the market; law enforcement efforts to crack down on pill mills; and stricter rules and regulations related to prescribing of controlled substances (Delcher et al., 2015)
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Department of Health and Human Services, in concert with state organizations that administer prescription drug monitoring programs, conduct or sponsor research on how data from these programs can best be leveraged for patient safety (e.g., data on drug–drug interactions) , for surveillance of policy and other interventions focused on controlled substances (e.g., data on trends in opioid prescribing, effects of prescriber guidelines)
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In connection with its prescribing guideline, the CDC has prepared a number of informational materials for patients on opioids and the risks associated with their use, as well as pharmacologic and nonpharmacologic alternatives for pain management (CDC, 2016b)
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. The intervention, which presented safety information in an interactive multimedia format, was administered to 62 adult outpatients who presented for treatment of chronic pain at pain management and dental clinics (McCauley et al., 2013)
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of an education program designed to raise awareness among patients with pain and the general public about the risks and benefits of prescription opioids and to promote safe and effective pain management (Recommendation 5-5) .16 Increasing Access to and Utilization of Medical Treatment for Opioid Use Disorder As discussed in Chapter 4, medication-assisted treatment (MAT)
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A buprenorphine initiative in Baltimore, Maryland, reduced opioid treatment waitlists and heroin overdose deaths by using a team of health care workers to support patients while they were in short-term treatment at a substance use disorder treatment facility, help them access Medicaid coverage, and refer them to outpatient providers for continuing care (Schwartz et al., 2013)
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and with use of opioid agonist therapies and buprenorphine in substance use disorder treatment facilities (Bauhoff et al., 2014; Ducharme and Abraham, 2008)
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Forty-eight states and the District of Columbia had past-year opioid misuse or dependence rates higher than their buprenorphine treatment capacity. While states varied significantly in their treatment need and capacity gap, most states (77.6 percent)
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examined variables affecting enrollment in treatment among Rhode Island young adult users of nonmedical prescription opioids. This study found that nonwhite race and low income, as well as previous incarceration and having experienced drug-related discrimination by medical providers, were associated with significantly lower rates of treatment enrollment (Liebling et al., 2016)
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Examining data from the Arrestee Drug Abuse Monitoring II program, Hunt and colleagues (2015) found that those with a history of heroin use had higher drug use and severity and higher rates of treatment utilization than those reporting use of other drugs.
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testing of the efficacy of therapies combining medication and behavioral treatment; and (4) testing of alternative pain management methods for reducing the iatrogenic effects of pain management on opioid addiction.
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Two of the most significant harms of opioid use are overdose and transmission of bloodborne infections due to injection drug use. As discussed in Chapter 4, opioid-related overdoses have soared in recent years; in 2015, more than 33,000 people died from opioid overdoses, nearly half of which involved a prescription opioid (Rudd et al., 2016)
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Naloxone is not a controlled substance and has no abuse potential, but when administered to people who are dependent on opioids, it may cause acute withdrawal symptoms, including vomiting. Overdoses can occur among all groups of opioid users -- those who use illicit opioids, those who misuse prescription opioids, and those who use opioids to manage pain as prescribed by a doctor.
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However, the paramedics and police officers were equipped with naloxone and were experienced in deal ing with overdoses, and all 26 people survived. Huntington has responded to its opioid problem by "throwing everything we know at the problem," including harm reduction strategies such as providing naloxone, medication-assisted treatment, and syringe exchange.
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. Making changes to the legal landscape requires, of course, some level of public support for the changes, and the public does not always support BOX 5-6 Improved Access to Naloxone in Rhode Island Rhode Island is among the top five states in per capita opioid overdose deaths (Rudd et al., 2016)
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Prescribing to third parties is permitted in 44 jurisdictions. The report also summarizes "Good Samaritan" laws, which provide varying levels of immunity from prosecution for those summoning emergency responders in the event of an overdose, including • immunity from prosecution for possession of controlled substances, and • immunity from prosecution for possession of drug paraphernalia.
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, despite the fact that nearly half of opioid overdoses involve a prescription drug (Clark et al., 2014)
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. Veterans are at particular risk of opioid-related harms, as many suffer from chronic pain and take opioids to treat it.
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Phillip Coffin, who oversees a project in which California clinics prescribe naloxone to any chronic pain patient who has used opioids for more than 3 months, says he is "looking for a change in the way that people interact with their opioid. The naloxone is there and will
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The CDC guideline for prescribing opioids recommends naloxone coprescription in similar cases, with an additional recommendation for those patients who are at risk of returning to high doses and who are no longer tolerant (e.g., patients recently released from prison) (Dowell et al., 2016)
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. Reducing Disease Transmission Syringe Exchange Sharing syringes and drug injection equipment puts people who inject drugs at high risk of being infected with HIV and HCV, as well as hepatitis B virus.
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. In late 2016, the CDC called on state and local health departments to improve access to syringe exchange, citing a CDC report noting that only one in four people who use injection drugs always use sterile injection equipment (Abbasi, 2017)
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• Is syringe exchange explicitly authorized by state law? Every state except Alaska criminalizes the sale or distribution of drug para phernalia, but many jurisdictions have some exemptions for drug injection equip ment: 7 jurisdictions explicitly exclude injection equipment from these laws, while 17 jurisdictions define syringes as illegal drug paraphernalia but have exceptions to allow for distribution of syringes to prevent bloodborne diseases.
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Evidence suggests that behavioral interventions -- such as trainings, education about safe injection practices, and motivational counseling -- can result in increased knowledge, safer and/or reduced drug use, and lower risk of overdose or transmission of disease. Research has shown, for example, that opioid overdose training that includes information about how to recognize an overdose and administer naloxone significantly increases knowledge and confidence in administration (Ashrafioun et al., 2016)
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Intervention in the emergency department is a fairly new strategy, so data on its effectiveness are limited, but early research suggests that this strategy can result in long-term behavior changes. A program begun in August 2014, for example, targets patients presenting with an opioid overdose in Rhode Island hospitals.
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The committee believes the restrictions, policies, and practices recommended in this report leave adequate space for responsible prescribing and reasonable access for patients and physicians who believe that an opioid is medically necessary. Another likely effect of restrictions on lawful access to prescription opioids is that some proportion of persons who have developed OUD will seek to satisfy their needs on the illicit market.
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Evaluate the impact of patient and public educa tion about opioids on promoting safe and effective pain management. The nation's public health leadership, including the surgeon general, the U.S.
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Recommendation 5-10. Improve access to naloxone and safe injection equipment.
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2017. Chronic pain management and opioid misuse: A public health concern (position paper)
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2012. Prescrip tion monitoring programs: An effective tool in curbing the prescription drug abuse epi demic.
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Safer, more effective pain management. https:// www.cdc.gov/drugoverdose/prescribing/patients.html (accessed February 17, 2017)
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2013. Prescription drug monitoring programs: An assessment of the evidence for best practices.
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2015. Abrupt decline in oxycodone-caused mortality after implementation of Florida's Prescription Drug Monitoring Program.
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2013. Model policy on the use of opioid anal gesics in the treatment of chronic pain.
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2016. Presentation to the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, Washington, DC, September 22.
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2017. Does brief chronic pain management education change opioid prescribing rates?
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2014. Benzodiazepines: A major component in unintentional prescription drug overdoses with opioid analgesics.
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2014. Prescription drug monitoring and drug overdose mortality.
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2014. Systematic literature review and meta analysis of the efficacy and safety of prescription opioids, including abuse-deterrent formulations, in non-cancer pain management.
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2011. Prescription drug monitoring programs and death rates from drug overdose.
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2015. Effect of Florida's prescription drug monitoring program and pill mill laws on opioid prescribing and use.
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Journal of Substance Abuse Treatment 48(1)
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2017. VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain.
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2017. States with prescription drug monitor ing mandates saw a reduction in opioids prescribed to Medicaid enrollees.
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