The ongoing opioid crisis lies at the intersection of two substantial public health challenges—reducing the burden of suffering from pain and containing the rising toll of the harms that can result from the use of opioid medications. In March 2016, the U.S. Food and Drug Administration (FDA) asked the National Academies of Sciences, Engineering, and Medicine (the National Academies) to convene an ad hoc committee to
- update the state of the science on pain research, care, and education since publication of the 2011 Institute of Medicine (IOM) report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, including the evolving role of opioids in pain management;
- characterize the epidemiology of the opioid epidemic and the evidence on strategies for addressing it;
- identify actions the FDA and other organizations can take to respond to the epidemic, with a particular focus on the FDA’s development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring; and
- identify research questions that need to be addressed to assist the FDA in implementing this framework.2
1 This summary does not include references. Citations for the findings presented in the summary appear in subsequent chapters of the report.
In the context of the growing opioid problem, the FDA launched an Opioids Action Plan in early 2016. One component of the FDA plan is to reassess the agency’s risk-benefit framework for opioid approval and monitoring. The FDA commissioned this study specifically to inform this reassessment.
The committee interpreted its charge as focusing primarily on prescribed opioids, although its analysis of the epidemiology of the opioid epidemic and strategies for addressing it took into account the diversion of prescription opioids into illicit markets and the impact of use of prescription opioids on use of illicit opioids, such as heroin. This analytical approach was necessary because markets for these drugs have been found to be interrelated. Furthermore, as the FDA cannot address the opioid problem on its own, the committee directs a number of its recommendations at other stakeholders, such as federal agencies other than the FDA, state agencies, and payers, among others.
Over the past 25 years, the United States has experienced a dramatic increase in deaths from opioid overdose, opioid use disorder (OUD), and other harms in parallel with increases in the prescribing of opioid medications for pain management. During the period from 1999 to 2011, the annual number of overdose deaths from prescription opioids tripled (see Figure S-1). While the annual number of deaths from prescription opioids remained relatively stable between 2011 and 2015, overdose deaths from illicit opioids (including heroin and synthetic opioids such as fentanyl) nearly tripled during this time period, driven in part by a growing number of people whose use began with prescription opioids. Drug overdose is now the leading cause of unintentional injury deaths in the United States, and most of these deaths involve an opioid. As of 2015, 2 million Americans aged 12 or older had an OUD involving prescription opioids, and nearly 600,000 had an OUD involving heroin.
Pain is a complex syndrome, often difficult to measure or treat, and is associated with comorbidities (e.g., depression); disability; and social costs, such as work absenteeism and increased utilization of medical resources. Accordingly, meeting the needs of the tens of millions of U.S. residents suffering from pain (including acute pain, chronic pain, or pain at the end of life) requires access to a broad armamentarium of therapies for pain management.
The vast majority of people who are prescribed opioids do not misuse them. However, opioids can produce feelings of pleasure, relaxation, and contentment, leading to an overreliance on these drugs in many patients and to misuse and OUD in others. Moreover, many lawfully dispensed opioids
make their way into the hands of people for whom they were not intended, including participants in illicit markets. As a result, harms associated with use of prescription opioids affect not only patients with pain themselves but also their families, their communities, and society at large.
The complexity of pain is matched by the complexity of achieving appropriate use of opioids in the context of the often suboptimal clinical management of pain within the fragmented U.S. health care delivery system. A further complication is the stigma associated with OUD and the persistent poor access to evidence-based OUD treatment services. The committee believes it is possible to stem the still-escalating prevalence of OUD and other opioid-related harms without foreclosing access to opioids for patients suffering from pain whose providers have prescribed these drugs responsibly.
PAIN MANAGEMENT AND PROGRESS AND FUTURE DIRECTIONS IN RESEARCH ON PAIN AND OPIOID USE DISORDER
Opioids are prescribed in a variety of settings for treatment of both acute and chronic pain. However, data demonstrating benefits of long-
term use of opioids to manage chronic noncancer pain are lacking, while the evidence clearly demonstrates that long-term use of opioids is associated with an increased risk of OUD and overdose as well as a number of other adverse outcomes (e.g., cardiovascular events, fractures). In studies in which OUD has been carefully defined, rates of OUD among individuals who were prescribed opioids to help them manage their pain have averaged about 8 percent, and estimates of combined rates of misuse, OUD, and aberrant behaviors thought to be indicative of OUD among people taking opioids for pain have ranged from 15 to 26 percent. Because of these risks, no widely accepted guideline for opioid prescribing recommends the use of opioids as a first-line therapy for management of chronic noncancer pain.
A number of nonopioid pharmacologic treatments can be used successfully to manage pain. While each such alternative has its own indications and risks, there are some circumstances in which nonopioid analgesics (e.g., nonsteroidal anti-inflammatory drugs) are likely to be as effective as opioids, or more so, for reducing pain associated with the conditions for which they are indicated, and when used appropriately, these analgesics carry a lower risk of adverse outcomes relative to opioids.
Nonpharmacologic interventions for pain treatment, including acupuncture, physical therapy and exercise, cognitive-behavioral therapy, and mindfulness meditation, also are powerful tools in the management of chronic pain. Many are components of successful self-management. While further research is needed for some nonpharmacologic interventions to better understand their mechanism of action and optimal frequency and intensity, they may provide effective pain relief for many patients in place of or in combination with pharmacologic approaches. Interventional therapies3 also have been found to be beneficial for the management of some forms of pain (e.g., low back and neck pain) in the context of a multidisciplinary approach. Research on interventional therapies is still developing.
Several advances in understanding pain and its treatment have occurred since the release of the 2011 IOM report Relieving Pain in America. The basic mechanisms related to MOPR (µ opioid receptor)-biased analgesia, inflammation, pain transmission, innate immunity, and treatment of neuropathic pain are now better understood. Likewise, progress in preclinical and translational research includes several developments related to the creation of nonaddictive alternatives to the opioid analgesics currently on the market. The movement toward pragmatic, practice-based trials is a critical step forward in clinical pain research. The ideal balance of opioid reduction in the context of more comprehensive pain management (e.g., stepped care models) continues to be investigated. Precision medicine (broadly defined)
3 Interventional pain management involves the use of invasive techniques, such as joint injections, nerve blocks, spinal cord stimulation, and other procedures, to reduce pain.
has the potential to improve clinical pain research and management, but is another area in which continued research is needed.
Little is known about why individuals who use prescribed opioids to alleviate pain develop opioid dependence or OUD, yet these outcomes have become a driving force in the opioid epidemic. Better identification of individuals at risk of OUD requires better characterization of the neurobiological interaction between chronic pain and opioid use. In particular, research on the interactions among pain, emotional distress, and reward, including pain-induced alterations in the reward pathway, would help in understanding and reducing the misuse potential of opioids.
Chronic pain and OUD are complex human conditions affecting millions of Americans and causing untold disability and loss of function. Yet despite the prevalence of pain and OUD and related costs to society and repeated calls to action (including the 2011 IOM report), research on pain remains poorly resourced.
Recommendation 3-1. Invest in research to better understand pain and opioid use disorder. Given the significant public health burden of pain and opioid use disorder (OUD) in the United States, the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, industry, and other relevant research sponsors should consider greater investment in research on pain and OUD, including but not limited to research aimed at
- improving understanding of the neurobiology of pain;
- developing the evidence on promising pain treatment modalities and supporting the discovery of innovative treatments, including nonaddictive analgesics and nonpharmacologic approaches at the level of the individual patient; and
- improving understanding of the intersection between pain and OUD, including the relationships among use and misuse of opioids, pain, emotional distress, and the brain reward pathway; vulnerability to and assessment of risk for OUD; and how to properly manage pain in individuals with and at risk for OUD.
TRENDS IN OPIOID USE AND HARMS
The level and type of risk to a patient from a given opioid are influenced by specific features of the medication itself, including the compound; the formulation (whether the medication is an extended- or immediate-release formulation and/or a combination product [coformulated with naloxone, acetaminophen, or aspirin]); and the route of administration. How opioids are prescribed (e.g., on an “as-needed” basis) also may influence the
risk of overdose. Studies consistently demonstrate that the risk of overdose increases in a dose-response fashion, that is, with increasing morphine-equivalent milligram doses.
It is also important to recognize that people who inject drugs are vulnerable to harms related to drug use that can be reduced by safe access to injection materials. New medications with “abuse liability” will be used by people with established patterns of injecting drugs. Tracking the toll of expected nonmedical use of specific products on the health of people who inject drugs is of public health importance.
Another critical feature of the opioid crisis is that the prescription and illicit opioid epidemics are intertwined; indeed, a majority of heroin users report that their opioid misuse or OUD began with prescription opioids. In addition, the declining price of heroin, together with regulatory efforts designed to reduce harms associated with the use of prescription opioids (including the development of abuse-deterrent formulations [ADFs]4), may be contributing to increased heroin use.
Recommendation 4-1. Consider potential effects on illicit markets of policies and programs for prescription opioids. In designing and implementing policies and programs pertaining to prescribing of, access to, and use of prescription opioids, the U.S. Food and Drug Administration, other agencies within the U.S. Department of Health and Human Services, state agencies, and other stakeholders should consider the potential effects of these interventions on illicit markets—including both the diversion of prescription opioids from lawful sources and the effect of increased demand for illegal opioids such as heroin among users of prescription opioids—and take appropriate steps to mitigate those effects.
Gaps exist in the reporting of data with which to accurately describe the epidemiology of pain, OUD, and other opioid-related harms in the United States, including how pain and OUD relate to one another and how often they co-occur. Closing these data gaps would improve understanding of pain, OUD, and overlapping prescription and illicit opioid use and enable more effective and measurable policy interventions.
Recommendation 4-2. Improve reporting of data on pain and opioid use disorder. The Substance Abuse and Mental Health Services Administration, the U.S. Food and Drug Administration, the National
4 Abuse-deterrent formulations are opioid medications designed to reduce the likelihood that they will be “abused.” For example, some opioid pills have properties that make them difficult to manipulate (e.g., crush) or that render them ineffective or unpleasant once manipulated.
Institutes of Health, and the U.S. Centers for Disease Control and Prevention should collaborate to identify best practices and reporting formats that portray the epidemiology of both pain and opioid use disorder accurately, objectively, and in relation to one another.
Recommendation 4-3. Invest in data and research to better characterize the opioid epidemic. The National Institute on Drug Abuse and the U.S. Centers for Disease Control and Prevention should invest in data collection and research relating to population-level opioid use patterns and consequences, especially nonmedical use of prescription opioids and use of illicit opioids, such as heroin and illicitly manufactured fentanyl.
OPIOID APPROVAL AND MONITORING BY THE U.S. FOOD AND DRUG ADMINISTRATION
The FDA traditionally has taken a product-specific approach to drug approval decisions by focusing on the data generated and submitted by a drug’s manufacturer and balancing the benefits revealed by those data against the risks known (and unknown) at the time of the agency’s review. While this approach works well in most cases, the committee believes it is necessary to view regulatory oversight of opioid medications differently from that of other drugs because these medications can have a number of consequences not only at the individual level but also at the household and societal levels.
Recommendation 6-1. Incorporate public health considerations into opioid-related regulatory decisions. The U.S. Food and Drug Administration (FDA) should utilize a comprehensive, systems approach for incorporating public health considerations into its current framework for making regulatory decisions regarding opioids. The agency should use this approach, in conjunction with advisory committee input, to evaluate every aspect of its oversight of prescription opioid products in order to ensure that opioids are safely prescribed to patients with legitimate pain needs and that, as actually used, the drugs provide benefits that clearly outweigh their harms. When recommending plans for opioids under investigation; making approval decisions on applications for new opioids, new opioid formulations, or new indications for approved opioids; and monitoring opioids on the U.S. market, the FDA should explicitly consider
- benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
- benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
- effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
- risks associated with existing and potential levels of diversion of all prescription opioids;
- risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and OUD; and
- specific subpopulations or geographic areas that may present distinct benefit-risk profiles.
To implement the systems approach proposed by the committee, it will be necessary to broaden the evidence used to demonstrate safety and efficacy during approval and for post-market monitoring. Specific means for meeting this need may extend beyond the protocolized setting of traditional clinical trials to encompass use of data from less traditional sources, such as online forums. The agency should consider reports of family members or other third parties affected by the drug, as well as data on outcomes in subpopulations that are at high risk of OUD or that exhibit mental health comorbidities common in patients with pain. Outcomes of interest include impact on function and long-term efficacy for pain reduction. Other data that could inform the agency’s decisions include the estimated impact of an opioid medication on the demand for and availability of all other prescription and illicit opioids, as well as interactions with other drugs (both prescription and illicit) commonly used with opioids or by people who use opioids illicitly. The FDA also should take steps to ensure that clinical development programs examine the full range of public health considerations.
Recommendation 6-2. Require additional studies and the collection and analysis of data needed for a thorough assessment of broad public health considerations. To utilize a systems approach that adequately assesses the public health benefits and risks described in Recommendation 6-1, the U.S. Food and Drug Administration (FDA) should continue to require safety and efficacy evidence from well-designed clinical trials while also seeking data from less traditional data sources, including nonhealth data, that pertain to real-world impacts of the availability and use of the approved drug on all relevant outcomes. The FDA should develop guidelines for the collection of these less traditional data sources and their integration in a systems approach.
Recommendation 6-3. Ensure that public health considerations are adequately incorporated into clinical development. The U.S. Food and Drug Administration (FDA) should create an internal system to scrutinize all Investigational New Drug (IND) applications for opioids. This review should examine whether public health considerations are adequately incorporated into clinical development (e.g., satisfactory trial design; see Recommendation 6-2). In implementing this recommendation, the FDA should rarely, if ever, use expedited development or review pathways or designations for opioid drugs and should review each application in its entirety.
The committee believes a commitment to transparency is critical to maintain balance between preserving access to opioids when needed and mitigating opioid-related harms and to maintain public trust.
Recommendation 6-4. Increase the transparency of regulatory decisions for opioids in light of the committee’s proposed systems approach (Recommendation 6-1). The U.S. Food and Drug Administration should commit to increasing the transparency of its regulatory decisions for opioids to better inform manufacturers and the public about optimal incorporation of public health considerations into the clinical development and use of opioid products.
The committee also believes aggressive use of the FDA’s currently available authorities, such as Risk Evaluation and Mitigation Strategies (REMS), safety labeling changes, and risk communications, is critical to supporting the safe and effective use of opioids.
Recommendation 6-5. Strengthen the post-approval oversight of opioids. The U.S. Food and Drug Administration should take steps to improve post-approval monitoring of opioids and ensure the drugs’ favorable benefit-risk ratio on an ongoing basis. Steps to this end should include use of risk evaluation and mitigation strategies that have been demonstrated to improve prescribing practices, close active surveillance of the use and misuse of approved opioids, periodic formal reevaluation of opioid approval decisions, and aggressive regulation of advertising and promotion to curtail their harmful public health effects.
Evidence on the effectiveness of the current REMS for opioids is limited. To improve the evidence on this REMS, the FDA could continue to evaluate the data on its performance, collecting additional data if needed, and then modify features of the REMS accordingly so that it more optimally ensures the evidence-based use of opioids.
Consistent regulatory oversight of opioid products under the committee’s proposed approach will necessarily raise concerns about the safety and efficacy of products currently approved for market. The committee believes the FDA has the authority and responsibility to reexamine the opioid class of drugs to ensure that these drugs remain safe and effective. The committee believes this could be accomplished in a relatively short time frame because the review would be limited to a single drug class for which substantial evidence already exists.
Recommendation 6-6. Conduct a full review of currently marketed/approved opioids. To consistently carry out its public health mission with respect to opioid approval and monitoring, the U.S. Food and Drug Administration should develop a process for reviewing, and complete a review of, the safety and effectiveness of all approved opioids, utilizing the systems approach described in Recommendation 6-1.
The process for U.S. Drug Enforcement Administration (DEA) scheduling of drugs also could benefit from the explicit incorporation of the public health considerations discussed in this report. The FDA and the DEA are already required to take “risk to public health” into account in making scheduling decisions, but the considerations included under this heading have not been enumerated in detail. Moreover, the ultimate impact on health outcomes related to these decisions remains largely unknown.
Recommendation 6-7. Apply public health considerations to opioid scheduling decisions. To ensure appropriate management of approved opioids, the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration should apply the same public health considerations outlined in Recommendation 6-1 for approval decisions to scheduling and rescheduling decisions, and study empirically the outcomes of scheduling determinations at the patient and population health levels.
STRATEGIES FOR ADDRESSING THE OPIOID EPIDEMIC
A constellation of policies, interventions, and tools related to lawful access to opioids and clinical decision making are available for use in reducing or containing opioid-related harms while meeting the needs of patients with pain. These strategies include those that (1) restrict the lawful supply of opioids, (2) influence prescribing practices, (3) reduce demand, and (4) reduce harm. The committee offers several recommendations based on its review of the evidence regarding the effectiveness of these strategies.
Each of these strategies entails costs and trade-offs. The committee believes the restrictions, policies, and practices recommended leave adequate space for responsible prescribing and reasonable access for patients and physicians who believe an opioid is medically necessary.
It also is important to keep in mind that restrictions on lawful access to prescription opioids can have other untoward effects: any policy designed to shrink the incidence of future OUD (and other harms) due to use of prescribed opioids by curtailing legal access to these medications will inevitably drive some people who already have OUD into the illegal market. In the committee’s view, it is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals who already have OUD.
Strategies for Restricting Supply
One recent controversy concerns whether any opioid should be permitted on the market unless it is an ADF. The committee applauds the FDA’s current cautious approach toward ADFs because the evidence is insufficient to warrant a recommendation on this question at this time. The potential for benefit remains counterbalanced by recent examples of unexpected harm. Ongoing studies will help clarify the optimal role for ADFs as a strategy for reducing misuse of prescription opioids.
States and localities also have regulatory authority over the practice of medicine in their jurisdictions unless their actions are preempted by federal action, and they have exercised that authority to stem the opioid epidemic. Overall, although further research is warranted, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community (e.g., regulations limiting days’ supply of opioid medications) may help curtail access. It should be emphasized, however, that none of these studies investigates the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed.
The available evidence suggests that drug take-back programs in the United States can increase awareness of the need for the safe disposal or return of many unused drugs, but effects of these programs on such downstream outcomes as diversion and overdose are unknown. Many drug take-back programs in the United States are once-per-year events. International examples and the recent success of a year-round disposal program at one pharmacy chain support policies expanding such programs to reduce the amount of unused opioids in the community.
Recommendation 5-1. Improve access to drug take-back programs. States should convene a public–private partnership to implement drug
take-back programs allowing individuals to return drugs to any pharmacy on any day of the year, rather than relying on occasional take-back events.
Strategies for Influencing Prescribing Practices
Current efforts to improve pain education and knowledge about prescription opioid misuse and OUD among prescribers are inadequate. Any meaningful effort to improve pain management will require a fundamental shift in the nation’s approach to mandating pain-related education for all health professionals who provide care to individuals with pain. Prescribing guidelines may be able to improve provider prescribing behavior, but may be most effective when accompanied by education and other measures to facilitate implementation.
Recommendation 5-2. Establish comprehensive pain education materials and curricula for health care providers. State medical schools and other health professional schools should coordinate with their state licensing boards for health professionals (e.g., physicians, nurses, dentists, pharmacists), the National Institutes of Health’s Pain Consortium, the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention, and the U.S. Drug Enforcement Administration to develop an evidence-based national approach to pain education encompassing pharmacologic and nonpharmacologic treatments and educational materials on opioid prescribing.
Insurance-based policies have substantial potential to reduce the use of specific prescription drugs, although their impact on health outcomes remains uncertain.
The judicious deployment of insurer policies related to opioid prescribing would benefit from a commensurate increase in coverage of and access to comprehensive pain management, encompassing both pharmacologic and nonpharmacologic modalities.
Recommendation 5-3. Facilitate reimbursement for comprehensive pain management. Public and private payers should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management encompassing both pharmacologic and nonpharmacologic treatment modalities.
Evidence suggests that prescription drug monitoring programs (PDMPs) can help address the opioid epidemic by enabling prescribers and other stakeholders to track prescribing and dispensing information. State laws
differ widely with respect to access to PDMP data, with some states denying access to certain stakeholders that could use the data to monitor opioid use and related harms. Some states do not require prescribers and/or dispensers to check PDMP information. As a result, PDMP data currently are not being used to their full potential.
Recommendation 5-4. Improve the use of prescription drug monitoring program data for surveillance and intervention. The U.S. Department of Health and Human Services, in concert with state organizations that administer prescription drug monitoring programs, should 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), for health service planning (e.g., data on discrepancies in dispensing of medications for treatment of opioid use disorder), and for use in clinical care (i.e., in clinical decision making and patient–provider communication).
Strategies for Reducing Demand
The committee’s recommended changes to provider education and payer policy should be accompanied by a change in patient expectations with respect to the treatment and management of chronic pain. The committee was struck in particular by the relative lack of attention to the impact of educating the general public (i.e., all potential patients) about the risks and benefits of opioid therapy and the comparative effectiveness of opioid and nonopioid analgesics and nonpharmacologic interventions.
Recommendation 5-5. Evaluate the impact of patient and public education about opioids on promoting safe and effective pain management. The nation’s public health leadership, including the surgeon general, the U.S. Centers for Disease Control and Prevention, and heads of major foundations and professional organizations, should convene a body of experts in communication and in pain and opioid use disorder to evaluate the likely impact (and cost) 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.
Medication-assisted treatment is the standard of care for OUD, even for special populations such as pregnant and postpartum women. Although several efficacious medications for treatment of OUD are available, they are
underutilized because of an array of factors, including insufficient numbers of providers eligible to provide OUD treatment, coverage barriers, and other limitations on access.
Recommendation 5-6. Expand treatment for opioid use disorder. States, with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration, should provide universal access to evidence-based treatment for opioid use disorder (OUD), including use of medication, in a variety of settings, including hospitals, criminal justice settings, and substance use treatment programs. Efforts to this end should be carried out with particular intensity in communities with a high burden of OUD. State licensing bodies should require training in treatment for OUD for all licensed substance use disorder treatment facilities and providers.
Recommendation 5-7. Improve education in treatment of opioid use disorder for health care providers. Schools for health professional education, professional societies, and state licensing boards should require and provide basic training in the treatment of opioid use disorder for health care providers, including but not limited to physicians, nurses, pharmacists, dentists, physician assistants, psychologists, and social workers.
Recommendation 5-8. Remove barriers to coverage of approved medications for treatment of opioid use disorder. The U.S. Department of Health and Human Services and state health financing agencies should remove impediments to full coverage of medications approved by the U.S. Food and Drug Administration for treatment of opioid use disorder.
Strategies for Reducing Harm
Life-saving medication for treating opioid overdose is available. The provision of naloxone to overdose victims by laypersons or health professionals in the prehospital setting is the standard of care, and community-based programs and other first responder agencies have adopted this protocol for treating opioid overdose. Mechanisms for increasing naloxone prescribing and dispensing, equipping first responders, and possibly enabling direct patient access (e.g., over-the-counter status) are warranted, but are impeded by high and unpredictable medication costs.
Recommendation 5-9. Leverage prescribers and pharmacists to help address opioid use disorder. State medical and pharmacy boards should
educate and train their members in recognizing and counseling patients who are at risk for opioid use disorder and/or overdose, and encourage providers and pharmacists to offer naloxone when an opioid is prescribed to these patients or when a patient seeks treatment for overdose or other opioid-related issues.
Recommendation 5-10. Improve access to naloxone and safe injection equipment. To reduce the harms of opioid use, including death by overdose and transmission of infectious diseases, states should implement laws and policies that remove barriers to access to naloxone and safe injection equipment by
- permitting providers and pharmacists to prescribe, dispense, or distribute naloxone to laypersons, third parties, and first responders and by standing order or other mechanism;
- ensuring immunity from civil liability or criminal prosecution for prescribers for prescribing, dispensing, or distributing naloxone, and for laypersons for possessing or administering naloxone; and
- permitting the sale or distribution of syringes, exempting syringes from laws that prohibit the sale or distribution of drug paraphernalia, and explicitly authorizing syringe exchange.
Years of sustained and coordinated effort will be required to contain the current opioid epidemic and ameliorate its harmful effects on society. Trends indicate that premature deaths associated with the use of opioids are likely to climb and that opioid overdose and other opioid-related harms will dramatically reduce quality of life for many people for years to come. Access to evidence-based treatment for OUD and efforts to prevent overdose deaths and other harms should therefore be increased substantially and immediately as a public health priority. Action by the nation’s political and public health leadership also is warranted to reduce the occurrence of new cases of prescription opioid-induced OUD through the implementation of scientifically grounded policies and clinical practices to promote responsible opioid prescribing and through advocacy for research aimed at identifying and developing nonaddictive alternatives to opioids for treatment of pain. The FDA has a crucial role to play in these efforts.
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