In a series of investigative journalism stories, The New York Times reporter Katie Thomas a , b , , a , b documented the criminal activity of InSys Therapeutics. Employees were indicted for offering bribes and kickbacks to doctors and nurses in exchange for their prescribing more of the company's fentanyl product, Subsys, and several of the company's former executives have been charged under the Racketeer Influenced and Corrupt Organizations RICO Act.
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.
Perhaps the best-known is an annual program sponsored by the DEA since Stewart et al. These programs are popular, and the literature on them is generally favorable, although all but devoid of high-quality evidence concerning effects on final outcomes, such as overdose Haegerich et al. Rather, the literature finds that the programs raise awareness e. However, while the quantities may be substantial in absolute terms, they represent a very small proportion of the total dispensed.
Egan and colleagues , for instance, found that over 4 weeks in one community, 21 million units of controlled medication were dispensed, but only 21 thousand were collected. Furthermore, evaluations of such programs generally cannot assess directly effects on such outcomes as OUD and mortality. Moreover, the reduction in harm may be even smaller than the reduction in volume of medications in circulation if the doses that are voluntarily surrendered are not the ones that would have caused OUD and death had they not been collected.
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One might speculate that people struggling with OUD or selling pills on the black market would be among those least likely to surrender pills voluntarily. On the other hand, it is important to note that asking whether take-back 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. Despite the effort invested in occasional take-back programs, proper disposal of unused medications is relatively rare in the United States Glassmeyer et al. Maughan and colleagues found that this was the case for a majority of opioid pills dispensed to patients who had undergone surgical tooth extraction. Likewise, Harris and colleagues found that one-third of patients prescribed opioids after dermatology surgery did not fill their prescriptions, and 86 percent of those who did had leftover pills.
And Welham and colleagues found that among opioid prescriptions returned for disposal, the majority of the dispensed amount was unused. A large proportion of respondents report keeping medications around, even when they are not needed, and then disposing of them improperly, whether in the trash or down the drain. Reducing misuse may not be sufficient motivation for members of the public at large to go much out of their way to return drugs; in one study, far fewer participants were motivated by concern about accidental poisoning 14 percent than by environmental considerations 45 percent or a simple desire to clean house 68 percent Gray and Hagemeier, The literatures on other environmental problems conclude that getting the public to do what is right e.
The United States has largely failed in this regard with respect to disposing of unused medications. Once-per-year take-back programs do not meet that test, and the patchwork of state, local, and pharmacy-specific programs may confuse and deter the public. By contrast, many peer nations have simple systems whereby most people can return any drug to any pharmacy on any day of the year. Australia's Return Unwanted Medicines program gets high marks in this regard, as do the programs in several of Canada's provinces, including British Columbia's Medications Return Program Daughton, Glassmeyer and colleagues report that many countries in Europe offer a similar service.
Sometimes these programs are funded by taxpayers, sometimes by the pharmaceutical industry, and sometimes by a mix of the two. Regardless of who pays, the basic idea of disposing of unwanted materials by operating the standard distribution system backward has many advantages and is a cornerstone of reverse logistics. Box provides further detail on one example of a national-level take-back program.
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, The Resource Conservation and Recovery Act exempts household hazardous wastes from many regulations, but when they are collected, they are regulated.
So it is perfectly legal for 1, individual consumers to dispose of their unused drugs in the worst possible manner, but if an organization collects those unused drugs and disposes of them in a much better but not ideal way, the organization performing that service may run afoul of the law. 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.
On September 9, , the DEA published new guidelines allowing certain DEA registrants to become authorized collectors of returned controlled medications DEA, , although it is unclear whether full advantage is being taken of that new flexibility. Certainly some organizations find ways to overcome the obstacles and create permanent drop-box options e. However, the advantages of allowing consumers to return medications on any day of the year to any of many locations they visit regularly e. As one example of early success, a U. Education for patients as to why safe disposal is important also is needed.
Kennedy-Hendricks and colleagues report that almost half of survey respondents who were prescribed opioids said they did not recall receiving any instructions regarding safe storage or disposal. The available evidence suggests that drug take-back programs in the United States can increase awareness about the safe disposal or return of many unused drugs, but effects of these programs on such downstream outcomes as diversion and overdose are unknown.
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As noted, moreover, many drug take-back programs in the United States are once-per-year events, and the patchwork of state, local, and pharmacy-specific programs may confuse the public. Nevertheless, 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. The committee recommends that states 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 Recommendation States vary widely in rates of prescribing opioids e.
There is, after all, a long history of published concern that misinformed and exaggerated fears about liability related to misuse of and addiction to opioids lead regulators to stifle the prescribing of these medications for patients who need them for pain relief e. What is less clear is whether one can infer from the variation among states or other evidence whether particular state policies are effective at reducing diversion and misuse of opioids without adversely impacting their availability for pain control.
Meara and colleagues , for example, find no association over a 7-year period between opioid-related outcomes in Medicare administrative data and states' adoption of controlled substance laws of the sort described further below. 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 , naloxone, and clinical guidelines, all of which are addressed separately in this chapter; the others are briefly discussed here. The pain clinic laws coincide with reductions in the number of clinics and the supply of drugs, but the nature of the evidence is weak. Florida is a special case, discussed further below. Studies of doctor shopping interventions are no better in terms of enabling causal inference concerning health outcomes.
One might say the literature documents that these policies exist and have been implemented, and in a dog-not-barking sense, infer that they can be implemented without resulting in obvious catastrophic failures. Furthermore, there are clear logic models for why one might expect these policies to have some beneficial effect. However, these studies are unconvincing if one adheres to the standards of scientific skepticism and disbelieves that interventions have any bottom-line effect unless clear evidence from high-quality empirical studies demonstrates this to be the case.
A Maine law that went into effect January 1, , for example, limits prescriptions for opioids or opioid-containing medications to morphine milligram equivalents MME per day. In addition, the law limits the number of opioid pills that can be prescribed to patients except in cases of inpatient, cancer-related, palliative, and end-of-life care, as well as treatment for substance use disorder to no more than a 7- and day supply for acute and chronic pain, respectively Traynor, In Massachusetts, a new law places a 7-day supply limit on first-time opioid prescriptions for adults and a 7-day limit at any time for minors.
One particular case study merits discussion: Florida's experience circa — Multiple policy interventions were being implemented simultaneously at that time, so it is impossible to use this case study as evidence concerning any one of them. Nonetheless, the changes in adverse outcomes were so abrupt both in absolute terms and relative to other states that it appears highly plausible that some combination of those interventions was responsible for the changes, and hence for averting thousands of premature deaths Chang et al. Meinhofer shows that these supply reduction measures more than tripled street prices for oxycodone and sharply reduced oxycodone-related mortality and hospitalization with apparently minimal spillover effects on other states, suppliers, or drugs—the only exception being some substitution of heroin, which was small relative to the reductions in oxycodone use.
She observes that in the years preceding the operation, —, Florida's oxycodone supply per capita had risen from close to the national average to quadruple the national average. After the intervention, it fell back to the national average. Consumption of various substitutes never departed appreciably from national averages, and no other state experienced a spike in oxycodone supply even close to the same magnitude as that experienced in Florida.
The effects were dramatic, with the time trajectory of oxycodone deaths mirroring that of oxycodone supply. On the one hand, this circumstantial evidence suggests that supply-side interventions against prescription opioids can have dramatic effects. On the other hand, Florida may have been experiencing a uniquely bad baseline situation in that may never again be replicated. Examining Texas's pill mill law, for example, Lyapustina and colleagues found reductions in the number of opioid prescriptions, number of pills dispensed, opioid volume, and average morphine-equivalent dose per transaction, but the reductions were 8—24 percent, not the enormous reductions seen in Florida.
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 may be effective.
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It should be emphasized, however, that none of these studies investigated the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed. Reducing prescribing of opioids is at once a tool both for reducing lawful supply by limiting the indications for prescribing them or otherwise reducing the number of patients holding prescriptions and for reducing demand, or aggregate desire for using or misusing the drugs.
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 authorized to prescribe these drugs.
The relief of pain represents one of the primary responsibilities of the practice of medicine Federation of State Medical Boards, Compared with the progressive advancement of medical education surrounding such fields as cardiology and oncology, advances in pain management education are entirely absent or minimally developed—often limited to a few hours of didactic lectures over multiple years of training.
Although detailed protocols have been developed through rigorous clinical trials for specific conditions e. 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. These efforts are summarized below for their respective agencies and organizations. Known by its modern name since , the FDA is the oldest consumer protection agency in the U.
Building on its key milestone, the legislation that outlawed adulterated and misbranded food and drugs, the FDA has grown in scope and size to ensure the health and safety of a broad range of therapeutics, including opioid and nonopioid analgesics. As detailed in Chapter 6 , the FDA reviews and approves new and reformulated drugs for use for defined medical indications.
Notably, provider participation in the educational component of the opioid REMS is currently voluntary, with unclear evidence of reduction in opioid-related harms or impacts on opioid prescribing FDA, b. See Chapter 6 for further discussion of the role the FDA's REMS can serve in ensuring that the benefits of prescription opioids continue to outweigh their risks. As discussed later in this chapter, this guideline, in whole or in part, is being integrated into a wide range of educational resources e.
It is too early to understand its impact on changes in the quality of pain management or on opioid analgesic prescribing practices. Directed research could track such outcomes, especially as components of the guideline are incorporated into various educational materials at the undergraduate and postgraduate levels, as well as for the public at large. As discussed later in this chapter, patient-centered management, aided by patient educational materials explaining the risks and benefits of long-term opioid use, could be useful in optimal clinical use of the guideline.
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.
As a result of a congressional mandate, for example, the NIH Pain Consortium, including representatives from 24 NIH institutes and centers, was established to coordinate pain research and disseminate its findings. Subsequently, the consortium held a workshop in on the state of pain education in the United States to help establish a way forward for the future of education for health care providers medical, dental, nursing, and pharmacy.
The findings of this meeting were as alarming then as they are now: the consortium concluded that the nation is failing to properly educate and train the next generation s of health care providers entrusted with relieving pain. Then as now, medical students were receiving on average only 8 hours of training in how to measure, diagnose, and treat pain. Some may receive too little, while others receive more than is warranted, for unspecified durations, and without the benefit of long-term follow-up to abate the risks of addiction or ensure that the plan is safe and effective. Sometimes, unfortunately, the result is OUD and its sequelae.
One of the key elements of this initiative is the production of interactive teaching tools, which other institutions can freely download and use to teach their students about pain and its treatment. An example of these modules can be found on the Pain Consortium website. Strengthening and expanding this critical effort represents a key opportunity for NIH to support education surrounding opioid analgesia. Resulting from a study conducted shortly after the passage of the Patient Protection and Affordable Care Act ACA , that report offers specific recommendations to 1 improve curriculum and education in pain management for health care professionals, and 2 increase the number of health professionals with advanced expertise in pain care.
Medical school education has been undergoing a transformation nationwide, requiring a complete redesign of curriculum to incorporate the early integration of clinical encounters, development of an interdisciplinary team approach to care models, and development of clinical competencies prior to graduation Satterfield et al. Despite this redesign, however, the tradition of pain management education in undergraduate curriculum has often been more robust in other disciplines, such as pharmacy, dentistry, nursing, and veterinary schools, relative to medicine.
In fact, according to one study, topics related to pain pathophysiology and management appear to be more developed in the training of physician assistants than in that of physicians Doorenbos et al. 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. This approach has been evolving in recent years so that students are increasingly challenged with clinically relevant reenactments.
In this case, Mr. 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. Numerous similar innovations, such as the learning models developed by the Academy of Medical Educators AoME, , are occurring across the country.
These integrated programs represent a broad opportunity for the expansion of pain curriculum at the nation's medical schools. They may also partially offset the influence of industry representatives that often inadvertently fill gaps in undergraduate medical education around prescribing practices Relman, Taken together, undergraduate medical education that integrates longitudinal, inquiry-based curriculum and that stresses interactive sessions over large lecture formats has the potential to greatly improve clinical care delivery for pain through improved communication and clinical competencies.
Additionally, the development of integrated topic pathways may improve the teaching of and competency in pain management by replacing traditional topic silos during the third-year core clerkships Poncelet et al. Such approaches are intended to break down traditional communication barriers and empower health care providers to embrace an interprofessional model of care that includes pain management—a model that increases the likelihood that all members of a treatment team will advise clinicians to use both pharmacologic and nonpharmacologic alternatives, including multimodal adjuvant therapies e.
In addition to efforts sponsored by individual professional schools, it may be hoped that modules developed through the NIH CoEPEs discussed above will allow additional pain education resources to be made available and introduced throughout any professional health care program. Despite the prominence and availability of Web-based patient care guidelines for the management of pain, whether issued by national or international professional societies e.
NATURE OF THE EVIDENCE
Primary care physicians, often represented by such organizations as the American Academy of Family Physicians, care for the vast majority of patients with acute and chronic pain, but may not be directly connected to or engaged in these pain society resources and thus must develop and provide their own educational resources for pain management see, for example, AAFP, Depending on their participation in such educational initiatives, the majority of physicians likely have practice and knowledge gaps that include inadequate understanding of pain assessment and diagnosis, especially in the context of chronic pain; inappropriate use of analgesic medications; failure to assess and reassess pain systematically and in the context of opioid use; and the inability to distinguish among opioid tolerance, physical dependence, and OUD Murnion et al.
Just as interprofessional approaches to undergraduate education have emerged, pain and addiction societies could work more closely with organizations supporting primary care providers, as well as seek to find the correct balance of industry sponsorship that does not unduly bias their educational content Relman, To varying degrees, SMBs also serve as an educational resource for clinicians in their state through the publication of relevant legal information e.
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. Current efforts to improve prescriber pain education and knowledge about prescription opioid misuse, such as the NIH CoEPEs, are inadequate and at risk of collapsing. Providers managing pain are often left to pick and choose from weakly supported alternatives.
Addressing this lack of alternatives is a topic discussed in Chapter 3. However, any meaningful effort to improve pain management will require a fundamental paradigm shift in the nation's approach to mandating pain-related medical education; completion of a brief online module will not be sufficient Holliday et al.
The committee recommends that state medical schools and other health professional schools coordinate with their state licensing boards for health professionals e. Food and Drug Administration, the U. Centers for Disease Control and Prevention, and the U. Drug Enforcement Administration to develop an evidence-based national approach to pain education encompassing pharmacologic and nonpharmacologic treatments and educational materials on opioid prescribing Recommendation As summarized in a Chapter 2 , there are many medical situations in which opioids might be considered an appropriate treatment option.
The most common indications include 1 acute pain management, such as after injury; 2 management of pain in the context of cancer or the end of life when accompanied by pain; and 3 management of chronic pain not due to a malignancy. Federal, state, and professional organizations have issued clinical guidelines for the use of opioids e. The issuance of these guidelines often is accompanied by such efforts as educational outreach, including continuing medical education CME , to foster implementation Haegerich, Acute pain is experienced commonly after surgical or dental procedures, traumatic injuries, and some normally transient medical conditions e.
Depending on the specific situation, opioids, nonopioid medications, nerve blocks, topical medications, and other measures might be used individually or combined in a multimodal approach see Chapter 2. As discussed in previous chapters, understanding and controlling opioid use in these situations is important as these routes of exposure may lead to long-term use, particularly in certain populations Sun et al.
Additionally, as detailed earlier, unused medications provided by hospitals, emergency rooms, and clinics may leak into the community and be used for nonmedical purposes Inciardi et al. The subject of guidelines for acute pain management currently revolves primarily around use rather than dosage or duration. Dosage guidelines are widely available and fairly widely accepted. However, opioids prescribed for acute pain syndromes have too often been provided at doses and dosing intervals and for durations unlikely to yield optimal effects Humphries et al.
One attempt at providing general guidelines for the use of opioids for acute pain was made by the Utah Department of Health, 13 and portions of these guidelines have been incorporated into the guidelines used by other states. The process of developing the guidelines involved broad representation of stakeholders on advisory and working groups. These guidelines call for opioids to be used only when nonopioid alternatives are deemed inappropriate, and for the drugs to be issued in carefully limited amounts in dosage and duration and after education of the patient concerning appropriate use and storage.
Various groups have independently developed guidelines for the prescribing of opioids for management of acute pain in emergency rooms del Portal et al. In one study, del Portal and colleagues found that opioid prescribing decreased significantly in an acute care setting from There do not appear to be any widely accepted guidelines for postoperative opioid prescribing, although one study found that the amount of opioid provided often was much larger than the amount required Hill et al. The suggestion recently was made that postoperative opioid prescribing be based on the specific surgical procedure, type of anesthesia used, patient age, and other variables Kim et al.
Guidelines for the management of back pain issued in by the American College of Physicians suggest using nonpharmacologic approaches for treatment of acute and subacute back pain, given that this type of pain often resolves on its own over time. When pharmacologic treatment for acute and subacute back pain is desired, the guidelines suggest the use of nonsteroidal anti-inflammatory drugs NSAIDs or skeletal muscle relaxants Qaseem et al. The use of opioids for the treatment of pain in the context of cancer and end of life is broadly supported by outcome studies.
While not adequately effective as sole analgesic agents in every patient, opioids, including morphine, oxycodone, fentanyl, and others, can reduce pain due to malignancies, including so-called breakthrough pain, a sometimes severe form of cancer pain of very rapid onset Zeppetella and Davies, The use of opioids for cancer pain is codified in the World Health Organization's WHO's analgesic ladder, one of the oldest and most widely accepted sets of opioid treatment guidelines WHO, Regrettably, 10—20 percent of cancer patients experience pain that is refractory to standard opioid management.
For these patients, a number of opioid- and nonopioid-based options have been described, but evidence is not yet sufficient to develop guidelines for their use Afsharimani et al. A number of studies have estimated compliance with cancer pain management guidelines. The results suggest that, despite the existence of various guidelines, pain assessment and reassessment and some other provisions of the guidelines are not always adhered to, and that pain control can be improved when guidelines are followed Du Pen et al. On the other hand, many more people are surviving cancer treatment than was the case during the development of the WHO guidelines.
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.
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. Of the sets of opioid prescribing guidelines currently available, that developed by the CDC is the most recent, comprehensive, and influential Dowell et al.
The CDC's inclusive process for developing the guideline emphasized the use of the Grading of Recommendations Assessment, Development, and Evaluation GRADE methodology to rate the quality of the evidence used in constructing the guideline, as well as the strength of the resulting recommendations. Department of Defense DoD , and others. The development process further involved constituents, including clinicians and patients.
Peer review of the guideline was solicited, as were public comments. Because the CDC guideline was issued only recently, its impact on prescribing practices remains unknown. Some have questioned the strength of the data behind some of the recommendations, such as the overall emphasis on improvement in function, as well as in pain control, in the consideration of whether benefits of using the drugs are expected to outweigh risks to the patient Pergolizzi et al.
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 drug screens and referral for specialty evaluation, and modest impacts on overall opioid prescribing rates, as well as overdose rates e. Moreover, strong state-level guidelines were associated with a reduction in the number of patients receiving high doses of opioids Garg et al.
Notably, multipronged efforts that include guidelines as well as other educational information for providers on how to prescribe opioids safely have been found to be associated with decreases in emergency department visits and deaths from opioid overdose Cochella and Bateman, ; Paone et al. These findings suggest that guidelines may be able to moderate the most aggressive opioid prescribing but are unlikely to be sufficient on their own to ensure the application of optimal medical practices in all cases, and that multipronged educational interventions and changes in reimbursement for pain management are required.
In an attempt to provide educational resources on the topic of pain management and opioid prescribing practices, many SMBs have either developed their own best practices preceding the release of the CDC guideline in or subsequently responded by incorporating foundational components of that guideline addressing key decisions encountered during clinical pain management. Although the CDC guideline was intended to serve as a broad resource for primary care physicians, it is being adapted and largely interpreted at the state level for all practicing physicians across the nation.
A brief review of three key CDC topic areas across the Web-based resources of five SMBs California, Florida, Kentucky, Ohio, and Washington on pain management and opioid prescribing practice reveals examples of content variability:. Many of the documents also recommend that opioids for acute pain be prescribed in limited amounts and doses consistent with the expected clinical course of the case such as postsurgical pain. Such state-to-state variation is to be expected, and often is due to the goal of the particular guidance document e.
States also may vary in the degree of autonomy that is customary among their physicians. 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, ; KBML, In short, there are wide disparities in the availability and comprehensiveness of SMBs' prescribing guidance.
This guidance is largely consistent with if not as broad and comprehensive as the CDC guideline. In summary, prescribing guidelines may be able to improve provider prescribing behavior but may be most effective when accompanied by provider education and other measures designed to facilitate implementation.
The use of electronic medical record EMR systems is expanding rapidly in both inpatient and outpatient medical settings. Use of EMRs was led by the VA, but aggressive federal policies have prodded many offices, clinics, hospitals, and integrated health care systems to employ the technology. Clinic notes, study results, laboratory values, pharmacy information, and other key data may be included. Compared with more traditional paper-based systems, EMRs offer potential improvements to health care delivery, including but not limited to increased efficiency, better adherence to guidelines and regimens, and fewer medical errors and related events Campanella et al.
These advantages could contribute to safer and more effective opioid prescribing for several reasons. First, notes documenting treatment and follow-up plans may be more easily located by consulting an EMR than by sorting through paper files, and delays in accessing the records are minimized when providers need patient information quickly.
Importantly, EMR systems containing sections for current medications, allergies, and other pharmacy-related information e. The electronic format is conducive to the use of treatment templates in which opioid follow-up assessments and ongoing prescribing plans can be included. At present, a modest amount of information helps inform the utility of EMRs and opioid prescribing in different settings. 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.
Use of EMRs, however, may not always discourage opioid prescribing. A regression analysis to analyze the prescribing behavior of primary care physicians with and without EMR systems showed that visits to physicians with EMRs were more likely to result in opioids being prescribed relative to visits to physicians using more traditional systems Harle et al.
Evidence on the effectiveness of clinical decision support systems CDSSs for opioids, incorporated within EMRs, is similarly conflicting. Trafton and colleagues describe a commendable attempt to iteratively improve and deploy a CDSS for primary care physicians treating chronic pain with opioids. In the end, while the CDSS did overcome some perceived barriers to guideline adherence e. Thus, the impact of electronic and other types of record-keeping systems on pain management or opioid prescribing, whether positive or negative, is not yet fully understood.
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. These policies, in turn, may result in marked differences in access to services and in desired outcomes.
Insurers, including sources of publicly funded health care coverage and pharmacy benefit managers, therefore can play a critical role in shaping clinical practices related to opioids and nonopioid alternatives for pain management. As a result of increasing recognition of the role such policies can play in improving analgesic care, examples are emerging of both reductions in inappropriate opioid prescribing and enhanced access to more comprehensive models of pain management. Haegerich and colleagues reviewed eight studies examining the effect of patient review and restriction PRR i.
Overall, the findings of this review are impressive. Four of the studies considered both cost savings and health outcomes. These studies generally found that in the four respective programs studied in Louisiana, Ohio, Oklahoma, and Washington , PRRs were associated with reductions in opioid use of one-third to one-half and with reductions in the number of patients able to successfully access multiple providers or pharmacies. The Washington study, which followed up patients 1 year later, also found significant reductions in emergency department and physician visits and in hospital costs Haegerich et al.
Four studies reviewed by Haegerich and colleagues examined drug utilization review DUR programs that review claims data to identify and notify providers of potentially problematic use patterns. Although none of these four studies evaluated health outcomes, all found reductions in drug utilization, and one RCT found reductions in numbers of prescribers and pharmacies used.
In a later study, Qureshi and colleagues , utilizing pharmacy claims data from members enrolled in a commercial health plan who met DUR criteria, found a State Medicaid programs have implemented the use of DUR to curb inappropriate opioid prescribing. Finally, Haegerich and colleagues also examined studies on prior authorization PA and quantity limit QL programs. PA requires review of medical justifications before drugs are covered by an insurer, while QL limits the amount of a drug that can be dispensed in a given time frame.
Haegerich and colleagues summarize the finding of Morden and colleagues that the 21 states that implemented PA in their Medicaid programs saw 34 percent reductions in oxycodone use over the study period, whereas those with more lenient PA policies witnessed a slight but nonsignificant increase. In summary, insurance-based policies, such as those involving PRR, DUR, PA, and QL, have substantial potential to reduce the use of specific prescription drugs, although their impact on health outcomes remains uncertain.
As discussed in Chapter 2 , there are multiple nonopioid pharmacologic e. Nevertheless, insurer policies affect access to and uptake of these treatment options. The IOM report Relieving Pain in America specifically points to misaligned incentives in fee-for-service insurance systems as a primary obstacle to comprehensive and effective pain management, citing lower or absent reimbursement of psychosocial or nonprocedural treatments IOM, 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 pain Cigna, ; McLaughlin, ; Oregon Health Plan, While relatively more expensive in the short term, integrated or multidisciplinary pain treatment programs have demonstrated long-term cost-effectiveness and increased functional improvement for patients Turk and Burwinkle, Promising clinical research into opioid dose reduction programs, more comprehensive pain management, and the effectiveness of nonopioid treatments for pain is discussed further in Chapter 3.
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 , the American College of Physicians, and FSMB, among others, that recommend careful initiation of opioids in the context of a comprehensive pain management plan Dowell et al.
Accordingly, the committee recommends that public and private payers develop reimbursement models that support evidence-based and cost-effective comprehensive pain management encompassing both pharmacologic and nonpharmacologic treatment modalities Recommendation PDMPs, currently authorized in every U. They require pharmacies and sometimes dispensing physicians to submit to a central office data on controlled substances prescribed and dispensed e.
These data can be monitored for patterns in prescribing and dispensing. Because PDMPs include virtually all data on prescriptions dispensed to a patient regardless of payment method, they allow for more complete monitoring than claims databases, which often are limited to data on payments for prescriptions within a particular network Brandeis PMP COE, In most states, PDMPs are administered by health departments, boards of pharmacy, or a single state authority. As of May , however, in only a handful of states New Mexico, New York, Ohio, Oklahoma, Utah, and Vermont were departments of health or commissioners of public safety authorized users of PDMPs, meaning that they are permitted to request and receive information on behalf of agency activities Davis et al.
Table shows other types of professionals who are authorized users by state. As is shown, several states do not permit access for mental health and substance use and other types of professionals who could potentially use the data to monitor opioid use and related harms. With respect to effects on prescribing practice and patient receipt of drugs from multiple health care providers, PDMPs are currently considered promising strategies based on before—after studies and time series analysis Haegerich, 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.
A recent analysis of Medicaid data suggests that mandatory prescriber registration with state PDMPs as opposed to mandatory use of them can lead to decreased prescribing of Schedule II opioids, although whether this resulted in safer prescribing or limited access to legitimate pain relief could not be assessed Wen et al. In patients for whom a decision is made to initiate or continue opioid therapy, the CDC guideline recommends that clinicians review PDMP data for high-risk drug combinations or dosages see Box , presented earlier.
None of the studies met criteria for the highest level of evidence RCT or meta-analysis.
Best practices based on the next level of evidence observational study with comparison group included using serialized prescription forms and sending unsolicited reports and alerts to prescribers, pharmacists, investigative agencies, and other relevant parties regarding questionable activity Clark et al. Current laws in most states allow for unsolicited reporting but vary somewhat in terms of the parties to whom the reports may be provided NAMSDL, see Figure Generally, data support the effectiveness of PDMPs in reducing the supply of prescribed controlled substances in the community, which is one, but not the only, causal factor in the risk of OUD and overdose.
Some states have worked to share PDMP data with other programs to support monitoring of prescribing patterns. Washington State's PDMP, for example, shares data with state Medicaid and workers' compensation programs to provide a more complete picture of controlled substances prescribed to patients. State program administrators reported that this effort supported improved identification of and early intervention for patients at risk for substance use disorder and overdose, led to reductions in costs associated with unnecessary prescription drug use and diversion and uncoordinated care, and improved education of prescribers about PDMPs, among other positive effects Brandeis PMP COE, These findings are not specific to opioids, however.
Unsolicited reporting of prescription drug monitoring program PDMP data to prescribers, dispensers, licensing boards, and law enforcement as of May 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. In Arizona, report cards summarizing prescribing over the past year were sent to outlier prescribers those for whom PDMP data indicated that the number or total dosage units prescribed were 1 standard deviation above the average in their specialty and county.
Preliminary findings for a county 1 year following implementation of the report cards show that the percentage of outlier prescribers fell from In such states as Kentucky and Texas, provision to investigators of information regarding problem prescribers is believed to have helped identify and address this problem, both through removal and by providers being encouraged to modify their prescribing practices Brandeis PMP COE, As noted earlier, some states allow substance use and mental health professionals to access PDMP data.
In treatment settings, the data may be used to check whether patients are being prescribed controlled substances. Limited evidence suggests that such access by these professionals may play a role in reducing opioid use by individuals in treatment Brandeis PMP COE, It is worth noting that federal law itself may pose an additional obstacle related to treatment for substance use disorder: 42 C.
Part 2 prohibits PDMP data from including any information related to substance use disorder services e. This provision carves out an additional area of patient privacy, often a contentious issue surrounding PDMPs, but necessarily excludes potentially relevant information from the PDMP.
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By reducing the availability of opioids from medical sources in the community, one might reasonably expect that PDMPs would reduce mortality from opioid overdose. Yet relatively few studies have evaluated the impact of PDMPs on opioid-related mortality, and the results of available studies are mixed Delcher et al. An analysis of observational data for the period to found no significant differences in rates of opioid overdose mortality and rates of opioid drug use between states with and without PDMPs Paulozzi et al. Until recently, for example, PDMPs were used primarily for law enforcement rather than public health purposes in most states, so an effect on drug overdose mortality might not be expected unless their use for this purpose had been articulated Green et al.
Additionally, utilization of PDMPs by health care providers was not included when the impact of PDMPs on overdose mortality or opioid use was assessed in two studies Green et al. In another study that evaluated mortality data in states and the District of Columbia with and without PDMPs during —, implementation of PDMPs was found not to be associated with reductions in drug overdose mortality in most states Li et al.
A time series, quasi-experimental study of Florida's PDMP found that oxycodone-caused mortality declined by 25 percent in the month after implementation of the PDMP in 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.
This may be because Florida circa , as discussed earlier in this chapter, may have been a unique case study that does not generalize well to other states. Another recent analysis that included all state PDMPs found that implementation of a PDMP was associated with a reduction in opioid-related overdose deaths of 1. Greater reductions in opioid-related overdose were observed in states where PDMPs included robust features, such as monitoring of greater numbers of drugs with abuse potential and at least weekly updating of PDMP data Patrick et al.
As of April , the interval for PDMP data collection was within a week or less in all states except Alaska, which will go to weekly reporting starting in July , and Montana which reports data every 8 days. The key objectives may be different for each project, but the concepts and the ability to use these capabilities for optioneering is flexible enough to apply everywhere.
For example, for planning purposes a user may want to evaluate a range of long-term population growth projections, consider the possible impacts of water conservation efforts, and look at the performance of the system over a series of time horizons 10 years out, 20 years out, and so on.
Through optioneering, every combination of inputs can be easily considered, simulated, and evaluated against the desired cost and performance criteria. And in design projects, users can look at a variety of possibilities: from simple things like different pipe sizes, to more complex things like entirely different routes for connecting subnetworks to the mains. Through optioneering, each of these ideas can be explored fully, to find the best balance between under-designing where the system may not perform under certain conditions and over-designing where the cost is too high.
WW: How about operations and maintenance projects -- is this optioneering process useful too? GH: Yes, definitely! There are numerous uses in operations and maintenance, from normal everyday things like reducing pumping costs, to smoothly handling planned outages, to dealing with emergencies swiftly and wisely. Pumping costs, for example, account for such a high proportion of a water utility's operating budget that it's important to actively manage and minimize energy consumption as much as possible while maintaining appropriate service levels.
Bentley's model management capabilities enable users to perform multiple energy analyses with alternative pricing for pumping stations in different parts of the system, so utilities can identify the best pumping strategies to save energy while avoiding system bottlenecks or water quality problems. In a recent interview with WaterWorld, Gregg Herrin offers his perspectives on the concept of "smart water" and how the Internet of Things plays into a smart water strategy. Different emergency types, such as contamination, power outages, fires, or pipe breaks can also be modeled in preparation for emergencies, enabling the utility personnel to estimate response time and resources needed, ultimately offering an intelligent pre-planning emergency response system.
And when a real emergency does happen, optioneering can help the utility respond with a fast and effective set of actions to control the situation and restore the system to its fully-functioning state. Even for standard maintenance, optioneering can help a utility execute planned outages better. And for rehabilitation practices, optioneering can assist a utility in evaluating the effects that various renewal strategies will have on the entire system. This allows an organization to make smarter decisions about their investments while reducing the risk of failures. GH: There are literally tens of thousands of engineers and modelers who use our optioneering tools to help drive their decision-making processes.
We are driven by their success, so we really enjoy seeing the positive impacts they make by optioneering with our applications. The Washington Suburban Sanitary Commission's Development Services Group , for example, reviews hydraulics for approximately proposed development plans per year, which include extensions of the water and sewer system as well as approximately small site utility plans that connect to the existing water and sewer network in two large Maryland counties. The hydraulic engineers are determining the appropriate sizes for the proposed mains, while considering various what-if scenarios that focus on the system integrity and needed infrastructure to provide adequate pressure and fire protection for future customers.