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Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence (2020)

Chapter: 5 Identifying and Prioritizing Indications for Clinical Practice Guidelines

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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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Suggested Citation:"5 Identifying and Prioritizing Indications for Clinical Practice Guidelines." National Academies of Sciences, Engineering, and Medicine. 2020. Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/25555.
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5 Identifying and Prioritizing Indications for Clinical Practice Guidelines In addition to developing a framework to evaluate existing clinical practice guidelines (CPGs) for opioid prescribing for acute pain, the National Academies of Sciences, Engineering, and Medicine (the National Academies) committee was tasked with identifying and prioritizing up to 50 specific surgical procedures and medical conditions that are associated with acute pain and for which opioid analgesics are commonly prescribed. The committee was also tasked with recommending where evidence-based CPGs would help inform prescribing practices. To accomplish this task, the committee considered the 1995 Institute of Medicine (IOM) report Setting Priorities for Clinical Practice Guidelines, which recommended that: six general criteria be applied in considering topics for either guidelines development or technology assessment. These criteria are prevalence of the clinical problem (number of affected persons per 1,000 persons in the general U.S. population); burden of illness imposed by the problem (individual mortality, morbidity, or functional impairment); cost (cost per person of managing the problem); variability in practice (significant differences in utilization rates for prevention, diagnosis, or treatment options); potential of a guideline or assessment to improve health outcomes (expected effect on health outcomes); and potential of a guideline or assessment to reduce costs (expected effect on costs to sponsoring organization, other relevant agencies, patients and families, and/or society generally). (p. 4) The committee agreed that the criteria in the 1995 IOM report would help it identify surgical and medical indications for which evidence-based CPGs for opioid prescribing for acute pain should be developed. However, it also recognized that obtaining and reviewing such information on all possible surgical and medical indications associated with acute pain and for which opioids have been prescribed would not be feasible in the committee’s timeframe. Ideally, evidence-based CPGs could be developed for all indications, but such a task might be prohibitive, given the rapid rate of change in treatment practices and the volume of information being generated on opioid prescribing and other acute pain interventions. For many indications, opioid prescribing practices continue to evolve as they integrate new evidence, such as the effectiveness of nonopioid pharmacotherapies for acute pain indications (e.g., 85

86 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN acetaminophen and nonsteroidal anti-inflammatory drugs), the introduction of opioid-sparing or highly restrictive acute pain protocols, and the implementation of state and federal policies restricting opioid prescribing in response to rising opioid-related morbidity and mortality. The committee’s approach to identifying and reviewing the literature and other data sources to develop the priority list of indications is detailed in Chapter 1 in the section on the committee’s approach. The committee’s method for identifying guidelines for the surgical and medical indications is given below. METHODS FOR IDENTIFYING PRIORITY SURGICAL AND MEDICAL INDICATIONS FOR CLINICAL PRACTICE GUIDELINE DEVELOPMENT The committee used the key factors in Box 5-1 to prioritize the surgical procedures given in Table 5-2 and the medical conditions given in Table 5-3 to produce a list of candidates for the development of CPGs. The committee deemed these indications to have the greatest potential public health impact based on the frequency of the surgical procedure or prevalence of the medical condition, the variation in opioid prescribing practices, and the potential harms in light of various patient- or procedural-related factors, such as prescribing for vulnerable patients (e.g., children and patients with a history of or cur- rent opioid use disorder). The committee notes that it considered all of the indications in the two tables to be priorities and did not rank them (they are listed alphabetically); thus, one indication should not be considered of greater priority than another in either table. After the list of priority indications had been developed on the basis of public health impact as described in Chapter 1, the committee determined whether some type of clinical guideline had been published for that indication. A literature search was conducted specifically to identify any guidelines published for the indications listed in Tables 5-2 and 5-3 (see Appendix B for the search strategy and the number of citations retrieved). The availability or lack of a guideline did not affect whether the indication was included in a table. Although the committee divided the list of indications into surgical conditions and medical conditions, it recognized the potential for overlap, as some medical conditions might ultimately require surgical or procedural interventions (e.g., nephrolithiasis), and some surgical indications may subsequently require medical management (e.g., cholecystectomy). The committee also conducted a literature search to identify CPGs that were specific for (1) opioids, (2) acute pain, and (3) a specific indication (see Appendix B for the search strategy and the number of citations retrieved). Few guidelines met all three criteria, but numerous guidelines met at least two of the criteria. For example, several CPGs broadly address both acute and chronic pain, but are not specific for a particular surgical or medical indication. These include the American Society of Interventional Pain BOX 5-1 Key Factors for the Prioritization of Indications for Clinical Practice Guideline Development • Prevalence of the surgical procedure or medical indication; • Variation in opioid prescribing across providers; • Variation in opioid prescribing in relation to patient-centered or patient-reported outcomes; and • Availability of an evidence-based CPG that describes opioid prescribing for acute pain associated with the indication.

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 87 Physicians (ASIPP) Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain, which includes an extensive evidence assessment (Manchikanti et al., 2012. Note: Page S83 of the guidelines says the principles may be “applied for patients who are treated for acute pain management, but also have other risk factors and for whom pain may become chronic”). ASIPP’s development process for the guidelines was based on the recommendations in the 2011 IOM report Clinical Practice Guidelines We Can Trust. CPGs such as the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain (VA/DoD, 2017) and the CDC Guideline for Prescribing Opioids for Chronic Pain (Dowell et al., 2016) also briefly address acute pain as well as chronic pain (see Chapter 3 for other examples of guidelines). Several evidence-based CPGs address acute pain following surgery but are not procedure specific, such as the Society for Pediatric Anesthesia’s recommendations on the use of opioids in children during the perioperative period (Cravero et al., 2019). If an indication had an evidence-based CPG on opioid prescribing for acute pain that met the committee’s analytic framework, it would not have been included in either Table 5-2 or Table 5-3; however, none of the CPGs or other guidelines reviewed by the committee for any of its selected indications did so. Challenges to Creating an Algorithm for Prioritization Because of the heterogeneity of the potential indications for acute pain, the committee did not create a standardized algorithm for prioritizing the creation of CPGs. For example, for some indications, such as carpal tunnel release, there is strong evidence of overprescribing, but the occurrence of these procedures is relatively infrequent compared with other procedures such as hernia repair (Steiner et al., 2017). Similarly, the committee deemed other indications, such as neck pain, to be of lesser priority for CPG development because of the heterogeneity in its presentation, cause, severity, and time course. As another example, although traumatic injuries are common, there is wide variety in the severity, treatment, and presence of other injuries that may make the creation of broad, overarching CPGs regarding opioid prescribing difficult. Finally, the availability of evidence was mixed for each prioritization factor across indications (e.g., the prevalence of the condition, the prevalence of opioid prescribing, variation in prescribing, and associated harms) and often not uniformly available, limiting the committee’s ability to account for or compare each of the factors across conditions and precluding a weight-of-the-evidence approach to prioritization. Realizing that others might prioritize conditions differently, the committee has provided the evidence it used to reach its priorities in Tables 5-2 and 5-3. The committee emphasizes that because of substantial variation in the presentation of acute pain, the list of priority indications developed by the committee in Tables 5-2 and 5-3 should not be considered to be as exclusive or exhaustive. There are other factors that may influence the inclusion of a condition for CPG development, including opioid prescribing practices, strong stakeholder advocacy, the probability of converting acute to chronic pain, and expert judgment. SURGICAL INDICATIONS OVERVIEW Surgical Care and Opioid Prescribing In 2014 there were approximately 17 million hospital visits related to 22 million surgical procedures in the United States (Steiner et al., 2017), and in 2009 there were approximately 548 million dental surgical procedures (Manski and Brown, 2012). Acute pain following surgical care is one of the most common indications for opioid prescribing. Currently, the majority (76% for adult and 60% for children) of opioid-naïve patients undergoing major and minor elective surgery procedures fill an opioid

88 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN prescription following surgery, and approximately 9% of opioid-naïve adult patients and 5% of pediatric patients refill prescriptions at least once in the postoperative period (As-Sanie et al., 2017; Harbaugh et al., 2018; Ladha et al., 2019; Sekhri et al., 2018). The committee recognizes that these numbers are likely to decrease in the next several years as opioid prescribing practices change in response to the awareness of opioid-related harms and alternative pain management approaches, the emergence of effective opioid alternatives, and state and organizational limits on opioid prescribing. Surgical care is often episodic, rather than longitudinal, which has several implications for guidelines for postoperative opioid prescribing. First, because the surgeon may not be involved in the long-term care after the surgery nor manage the entirety of a patient’s comorbid conditions and associated medications, care is often transitioned to other providers, such as primary care clinicians. As such, postoperative opioid prescribing requires appropriate coordination with the patient’s other health care providers, particularly those providing ongoing care for patients using opioids at the time of surgery or at high risk for chronic pain and chronic opioid use or misuse (Klueh et al., 2018). Moreover, ongoing opioid decisions may be transferred to other providers. For example, many patients undergoing total knee arthroplasty are taking opioids at the time of surgery, and thus primary care providers may bear the burden of postoperative opioids prescribing for ongoing joint pain (Bell et al., 2018). Therefore, when possible, it is important to communicate and plan for opioid prescribing prior to surgical care in order to ensure safe pain management, the avoidance of high-risk prescribing behaviors (e.g., multiple overlapping prescriptions and prescriptions from multiple providers), and the avoidance of ongoing opioid prescribing when other interventions may be preferable or equally effective. In addition, surgical care presents an important opportunity for quality improvement initiatives. Recent initiatives, such as the use of perioperative antibiotics or venous-thromboembolism prophylaxis, are routinely incorporated into quality metrics by key stakeholders (e.g., health insurers, policy makers, health care organizations, and professional societies) in order to benchmark providers. Because procedures are performed by defined groups or specialties, health care organizations have the opportunity to track pain- and opioid-related outcomes as well as opioid prescribing in order to create best practices, identify outliers, and enhance the safety and quality of postoperative pain management. The committee notes that it found more evidence of variation in opioid prescribing and discrepancies in opioid prescribing, opioid consumption, and pain-related outcomes for surgical procedures than for medical conditions causing acute pain (see Tables 5-2 and 5-3). Variation in Prescribing for Surgery In the absence of CPGs, current prescribing often represents a provider’s judgment regarding the amount of opioid, if any, a patient will require following surgery. In contrast to chronic pain, opioid prescribing for acute pain following procedural care is typically provided on an as-needed basis. Acute postoperative pain is expected to subside with the resolution of inflammation and with the healing of the tissue, typically within 3 months after the index procedure, although the precise level of pain is dependent on both patient and procedural factors (Schug et al., 2019). As such, the extent of tissue injury may influence opioid prescribing, and patients undergoing larger or more “invasive” surgical procedures (e.g., greater dissection, tissue injury, and length of surgery) may require a greater amount of pain medication than is necessary for less extensive procedures. In contrast with other types of care for which opioid prescribing has remained flat or declined, there is some evidence that prescribing for surgical, dental, and emergency care has been increasing—ac- cording to one study, by 15.8% between 2010 and 2016 (p<0.001) (Larach et al., 2018). During this period, outpatient postoperative opioid prescribing among primary care and other specialties decreased by about 9% (Larach et al., 2018). The authors found that the amount per person and the prescribing rate

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 89 for high-dosage prescriptions, short-term prescriptions, and extended release and long-acting formula- tions decreased over that period, whereas the duration and prescribing rate for long-term prescriptions of opioids increased. Multiple studies have found a wide variation in opioid prescribing within procedures in adults and children (Anderson et al., 2018; As-Sanie et al., 2017; Cartmill et al., 2019; Horton et al., 2019a; John- son and Makai, 2019; Madsen et al., 2018; Osmundson et al., 2017). Makary et al. (2017) found that following laparoscopic cholecystectomy, opioid prescriptions ranged from zero to more than 50 pills, with only about one-fifth of the surgeons prescribing within institutional prescribing guidelines of ≤10 pills. Variations in opioid prescribing were found for children after anterior cruciate ligament (ACL) repairs, appendectomy, cholecystectomy, and hernia repair (Anandarajan et al., 2019; Denning et al., 2019; Pruitt et al., 2019; Sonderman et al., 2018). Johnson and Makai (2019) described postoperative prescribing following minimally invasive gynecologic surgery as ranging from 125 to 300 oral morphine equivalents. In addition, Ziegelmann et al. (2019) described wide variation within procedure type for patients undergoing open nephrectomy, cystectomy, and retroperitoneal lymph node dissection. Opioid prescribing may vary by provider type and hospital. In a statewide analysis of hospitals, prescribing was found to vary 4.7-fold across centers, and prescriptions provided by advanced practice providers were 18% higher than prescriptions provided by physicians (Cron et al., 2018, 2019; Lund et al., 2019). Similarly, for surgical care that occurs in teaching hospitals, prescribing may differ between surgeons in training and other prescriber types (Bhashyam et al., 2019; Bicket et al., 2017; Chiu et al., 2018; Cron et al., 2019; Lancaster et al., 2019). Excessive Prescribing In addition to demonstrating variation in prescribing, a number of studies have also found exces- sive opioid prescribing (Cartmill et al., 2019; Horton et al., 2019b; Paulozzi et al., 2014; Sonderman et al., 2018). These studies suggest that efforts to reduce opioid prescribing for postoperative pain so that they align more closely with patient-reported opioid use may yield comparable outcomes with respect to pain, satisfaction, and postoperative quality of life. For example, recent studies suggest that postoperative opioid use can be decreased as a result of provider- and health care–system interventions (Hill et al., 2018b), policy and legislative measures (Dave et al., 2019), and enhancing patient education and engagement in postoperative pain management (Alter and Ilvas, 2017). A recent study of pediatric patients undergoing outpatient surgery found that after the implementation of institutional guidelines, most patients were not prescribed opioids following surgery, did not report opioid use, did not require refills, and that a greater proportion of patients were directed to and used nonopioid alternatives for postoperative pain management (Harbaugh et al., 2018). Risk of Prolonged Postoperative Opioid Use Recent studies assessing the risk that opioid-naïve patients, including both adults and children, will transition to prolonged opioid use following surgery have produced probabilities ranging from 1% to 15% (Alam et al., 2012; Clarke et al., 2014; Sun et al., 2016). For example, Sun et al. (2016) found that male sex, age older than 50 years, and a preoperative history of drug abuse, alcohol abuse, depression, benzodiazepine use, or antidepressant use were associated with chronic opioid use among adult surgi- cal patients. The risk factors for persistent opioid use among pediatric surgical patients include older age, female sex, previous substance use disorder, family opioid use, chronic pain, and preoperative opioid use (Harbaugh et al., 2018). Other studies have demonstrated that postoperative opioid use may

90 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN be correlated with a number of other patient factors beyond patient-reported pain or procedure type, such as anxiety, mental health conditions, medical comorbidities, and prolonged opioid use, which may not entirely reflect ongoing pain (Badreldin et al., 2018; Brummett et al., 2013; Committee on Practice Bulletins—Obstetrics, 2018; Hilliard et al., 2018; Kelly et al., 2018; Velanovich, 2000). Finally, there is growing evidence that a greater amount of opioid being prescribed prior to or at the time of surgery is correlated with greater opioid consumption and a higher risk of prolonged opioid use (Brummett et al., 2017; Gil et al., 2019; Howard et al., 2018a). Classification of Surgical Indications The classification of surgical procedures for creating CPGs for postoperative outpatient opioid prescribing may be framed in multiple ways. In order to facilitate the prioritization of surgical procedures for possible CPG development, the committee sought to categorize procedures into groups that might be most amenable for CPG development. Notably, the committee did not identify any classification frameworks for surgical procedures based on patient attributes, surgical intensity, or tissue injury. The committee believes that such groups would reflect the practicalities of clinical care, which could facilitate the creation and dissemination of a CPG. For example, surgeons often perform multiple types of procedures, and opioid prescribing may not be specific to an individual procedure type. In particular, one study showed that when opioid prescribing for laparoscopic cholecystectomies was reduced, there was a spillover effect of reduced opioid prescribing for other surgeries of similar scope and tissue injury (Howard et al., 2018a), suggesting that guidelines created for one procedure type may have applicability to other procedures. Moreover, observational studies often group procedures together when examining postoperative opioid use and prescribing. For example, recent studies that examined opioid prescribing and use after surgical procedures were often aligned within surgical specialty or by technical approach or grouped by anatomic location (Fleischman et al., 2019; Hill et al., 2017, 2018b; Horton et al., 2019b; Howard et al., 2018b) (see Table 5-1). In this report the committee chose to align surgical conditions and procedures based on similarities in operative approach (e.g., laparoscopic, open), anatomic region (e.g., abdominal cavity, extremity, thoracic procedures), underlying cause of injury (e.g., sports-related injuries), or where the surgery is performed (e.g., inpatient or outpatient). Each of these attributes may influence the amount and duration of opioids prescribed following surgery, if they are prescribed at all. While discussed individually, in practice these categories are not mutually exclusive, and CPGs may be based on whatever single attribute or combination of attributes that is most clinically relevant. However, creating more granular CPGs for specific surgeries based on procedural nuances may be an opportunity in the future as the knowledge gaps regarding tissue injury, acute pain, and opioid requirements close with future research. For example, laparoscopic cholecystectomy procedures may be performed on an emergency basis or electively and in either inpatient or outpatient settings, and the majority of current evidence has focused only on these performed on an elective, outpatient basis. CPGs developed for elective, outpatient laparoscopic cholecystectomies could be applied to cases performed on an emergency basis or in an inpatient setting, or they could be refined in future work for the nuances of these aspects of clinical care. The section below provides a rationale for the classification of surgical procedures in order to provide clarity on the groups selected for prioritization in the committee’s Statement of Task and to inform efforts for future CPG development in which stakeholders may opt to classify procedures differently.

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 91 TABLE 5-1  Attributes for Classifying Surgical Procedures for Clinical Practice Guideline Development Attribute Examples Considerations Surgical Dental, endoscopic, endovascular, Allows for the tailoring of guidelines toward size of approach laparoscopic, robotic, thoracoscopic, incision and extent of soft tissue injury. open techniques Timing of Elective, emergency, urgent May capture differences in condition severity, such procedure as inflammation or infection, which may differ by presentation for the same procedure. Indication Childbirth, inflammatory processes, May capture the nuances of conditions that supersede malignancy, symptomatology, trauma approach or anatomic location. May not allow for commonalities across disciplines or techniques regardless of condition. Anatomic Abdominal cavity, abdominal wall, Allows for a broad categorization of procedures beyond location extremity, oral cavity, oropharyngeal condition, surgical discipline, or technique. Care setting Inpatient, outpatient, observation May account for the differences in opioid consumption that may exist based on duration of recovery that occurs within a facility. Surgical Approach CPGs for postoperative opioid prescribing also could be considered according to their procedural attributes, including the surgical approach, indications, and anatomic location. For example, CPGs could be created based on the technical approach for the procedure, such the use of open or minimally invasive techniques, including laparoscopic, robotic, endoscopic, and endovascular strategies and dental procedures. Classifying procedures by surgical approach is advantageous in that techniques may better capture the magnitude of tissue injury due to the extent of the incision and dissection. In addition, classification by approach may allow similar procedures to be grouped together. For example, the extent of tissue injury for a laparoscopic hysterectomy may be similar to the tissue injury of a laparoscopic colectomy, and the opioid consumption and pain trajectories identified for certain procedures may translate to other procedures based on operative approach (AJRR, 2017; Kremers et al., 2015). Although the extent to which incision size directly correlates with patient-reported postoperative pain and analgesic use is not well understood, numerous studies have demonstrated that minimally invasive approaches yield faster recovery and less patient-reported pain (Hota et al., 2018; Leach et al., 2018; Theisen et al., 2019). Thus, procedures could be grouped together by operative approach when considering CPGs, such as all laparoscopic abdominal or pelvic procedures being considered under common recommendations (Sloan et al., 2018). This approach may also be clinically intuitive for prescribers, since spillover effects into procedures of similar scope and approach have been observed after implementing opioid prescribing protocols or other enhanced recovery (Bedard et al., 2017; Bicket et al., 2019; Johnson and Makai, 2019; Kahlenberg et al., 2019). Timing of Procedure Surgical procedures may also be classified by the timing of intervention, such as elective, urgent, or emergency surgical procedures. Differences in timing may reflect important differences in the severity of

92 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN and underlying pathology for surgery. For example, a laparoscopic cholecystectomy performed electively may have far less inflammation and tissue injury related to additional surgical dissection than a procedure performed urgently or in an emergency situation for acute infection, perforation, or gangrenous changes (Mou et al., 2019; Roulin et al., 2016; To et al., 2013). Similarly, an elective hip arthroplasty performed for symptomatic osteoarthritis may differ substantially from a procedure performed for a hip fracture, in which underlying frailty, comorbid conditions, and physical function may create a much different pain trajectory and risk of opioid prescribing following surgery (Charette et al., 2019; Kester et al., 2016; Schairer et al., 2017). Most third molar extractions at an early age (mean age 19 years) are another example of an uncomplicated elective procedure. In contrast, emergency extractions performed for teeth with pulpal and periapical infections that result in a disseminating cellulitis and potential airway obstruction may require more extensive treatment and follow-up (Resnick et al., 2019). Given these nuances in care, the timing and acuity of surgical conditions will inform CPGs for acute pain following surgery. Indication and Anatomic Location Surgical procedures could also be classified by the indication for the procedure or anatomic location. For example, procedures could be grouped by anatomic region, such as extremity, torso, or head and neck. The advantages of this approach are that these categories may align with surgical disciplines, such as otolaryngology or gastrointestinal surgery, which are clustered in anatomic regions (Fujii et al., 2018; Johnson and Makai, 2019; Sabatino et al., 2018; Sloan et al., 2018). However, categorizing by anatomic site alone may not capture the extent of tissue injury for procedures, nor the differences in indication, such as malignancy, which may influence the extent of the operation and the expected course of pain and recovery after surgery. In addition, the postoperative pain trajectory may be associated with the type of tissue involved in the procedure. For example, patients undergoing upper extremity procedures involving only skin and soft tissue require fewer opioids than patients undergoing fracture repair or joint procedures (Fujii et al., 2018). Finally, tissue injury, inflammation, pain, and recovery may vary by indication, such as malignancy, inflammation, trauma, degenerative disease, or infectious conditions. For example, patients undergoing breast reconstruction had longer duration of opioid use than patients undergoing benign breast resections, who used more opioids initially but then quit their use more quickly. Surgical Setting Finally, from a health care delivery perspective, surgical procedures may be categorized by the setting in which the surgery occurs and the need for an inpatient stay. Postoperative pain requirements may be different for similar procedures performed in either an inpatient or an outpatient setting. For example, patients undergoing total knee arthroplasty may undergo the procedure with a planned inpatient stay, in which both intravenous and oral opioid regimens are available for postoperative pain control and monitored by health care staff. Alternatively, for patients undergoing total knee arthroplasty as an outpatient procedure, postoperative prescribing may need to anticipate the potential pain requirements the patient will experience at home. Therefore, prescribing guidelines may need to address whether the procedure is to be performed in an inpatient or outpatient setting. If the procedure is to be inpatient, the duration of an inpatient hospital stay may be a factor in determining the opioid prescribing regimen, as postoperative pain may decline to levels in which opioids are not necessary at discharge.

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 93 Priority Surgical Indications for Clinical Practice Guideline Development The committee used specific criteria (see Box 5-1) and explored numerous attributes (see Table 5-1) for identifying the groups of common surgical procedures that it considered priorities for the development of evidence-based CPGs. Many of the surgical procedure groupings apply to pediatrics as well as adult populations, including sport-related injuries, spine procedures, laparoscopic abdominal procedures, and thoracic procedures. Despite this overlap between pediatric and adult patients for many of the surgical groupings, the committee did recognize surgical procedures that are generally unique to pediatrics, such as cleft and craniofacial procedures, correction of pectus excavatum, and correction of congenital limb and hip anomalies (e.g., femoral malformations, acetabular osteotomy, leg length discrepancy). In response to the committee’s Statement of Task, the following surgical procedures and the reasons for their grouping are briefly summarized below; information supporting their prioritization is given in Table 5-2. • Anorectal, pelvic floor, and urogynecologic procedures (vaginal/perineal approach) • Breast procedures • Dental surgeries • Extremity trauma requiring surgery • Joint replacement • Laparoscopic abdominal procedures • Laparoscopic or open abdominal wall procedures • Obstetric procedures • Open abdominal procedures • Oropharyngeal procedures • Spine procedures • Sport-related injuries • Thoracic procedures In prioritizing the surgical procedures listed in Table 5-2, the committee focused on procedures for which there was evidence of opioid prescribing, noting the possibility of variation in prescribing across providers and in relation to patient-reported outcomes or patient-centered outcomes. The committee notes that several common surgical procedures identified by Steiner et al. (2017) are surgeries for which outpatient postoperative opioid prescribing is exceedingly rare (e.g., cataract surgery, myringotomy, and tympanos- tomy tube placement); these were thus also determined to be less of a priority for CPG development. For example, Steiner et al. (2017) determined that of the almost 10 million ambulatory or inpatient surgeries performed in 2014, lens and cataract procedures were the most prevalent, at about 1.4 million procedures; however, opioids are rarely prescribed for pain following cataract surgery (Shoss and Tsai, 2013). There are also many surgical procedures performed on infants and children in which opioids are aggressively used both intra- and postoperatively, such as posterior spinal fusion for scoliosis and hip reconstruction for dysplasia, but prospective data are not available to guide subsequent opioid dosing. For example, evidence suggests that opioid alternatives are superior for pain management following myringotomy and tympanos- tomy tube placement in children, and opioids are rarely prescribed (Pappas et al., 2003). Table 5-2 details the existing evidence and current guidelines for opioid prescribing for specific indications. These guidelines range from those developed at the institutional level (e.g., Overton et al., 2018) to those at the national level (e.g., Hegmann et al., 2014). For example, Overton et al. (2018) developed consensus recommendations for opioid prescribing after 20 common surgical procedures; stakeholders in this consensus process included surgeons, pain specialists, outpatient nurses, pharma- cists, and patients. Other groups, such as the Michigan Opioid Prescribing Engagement Network, have created guidelines on the basis of patient-reported outcomes, specifically patient-reported postoperative opioid use following various procedure types (Vu et al., 2019).

94 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2  Opioid Prescribing Patterns for Priority Surgical Indications Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Anorectal, In 2014, 2.5% of all 42 patients were prescribed an The American Society of Colon and pelvic floor, and inpatient surgical average of 150 OMEs after vaginal Rectal Surgeons Clinical Practice urogynecologic procedures were hysterectomy, only 50 OMEs Guidelines for the Management of procedures colorectal resections, were used by patients in the first Hemorrhoids—“Patients undergoing (vaginal/perineal for a rate of 2 weeks, and only 4 patients surgical hemorrhoidectomy should approach) (e.g., 94.8/100,000 people requested opioid refills (As-Sanie use a multimodality pain regimen to colon resection, (McDermott et al., et al., 2017). reduce narcotic usage and promote a hemorrhoidectomy, 2017). faster recovery” (Davis et al., 2018). vaginal 122 patients were overprescribed Opioid studies were included. hysterectomy) In 2014, 262,200 by an average of 149%, 165%, (1.5%) of all 17.2 and 136% MMEs for sacral Clinical Practice Guidelines for million ambulatory neuromodulation, mid-urethral Enhanced Recovery After Colon and or inpatient surgeries sling, and prolapse repair, Rectal Surgery from the American were vulvar, and respectively; there was a Society of Colon and Rectal female pelvic significant reduction (p<0.001) in Surgeons and Society of American procedures, for a MMEs prescribed after educational Gastrointestinal and Endoscopic rate of 59.2/100,000 intervention (Moskowitz et al., Surgeons—“A multimodal, opioid- people (Steiner et 2019). sparing, pain management plan should al., 2017). be used and implemented before the Among 57 women undergoing induction of anesthesia.” Minimizing In 2014, 508,700 pelvic organ prolapse surgery, only opioid use is associated with earlier (~3.0%) of 17.2 32.8% of prescribed OMEs were return of bowel function and shorter million ambulatory consumed; after implementation length of stay (Carmichael et al., or inpatient surgeries of prescribing recommendations, 2017). were abdominal total OMEs decreased by and vaginal 45%, amount of leftover pills hysterectomies decreased (p<0.0001), but refills (Steiner et al., increased (p=0.03), with similar 2017). satisfaction scores before and after implementation (Linder et al., 2019).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 95 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Breast In 2014, 305,600 At 1–2 weeks following John Hopkins Opioid-Prescribing procedures (e.g., of 17.2 million mastectomy with immediate Guidelines for Common Surgical lumpectomy, ambulatory or reconstruction, 23 patients Procedures: An Expert Panel mastectomy, inpatient surgeries received median prescriptions Consensus—Developed consensus reconstruction, were lumpectomies of 550 MMEs and 77% of the ranges for outpatient opioid reduction) (1.8%); 103,500 MMEs were unused with 83% prescribing at the time of discharge were mastectomies satisfaction; among 27 patients for partial mastectomy with or without (0.6%); and 410,100 receiving 263 median MMEs, sentinel lymph node biopsy (Overton were therapeutic there was 58% MMEs unused with et al., 2018). surgical procedures 93% satisfaction; 1 and 2 patients, of skin and breast, respectively, required refills (Sada including plastic et al., 2019). surgery on breast (2.3%) (Steiner et Of 5,233 TRICARE patients al., 2017). undergoing mastectomy, 31.5% required ≥1 opioid refill (Scully et al., 2018). 10% of 4,113 patients undergoing mastectomy continued to fill an opioid prescription 90 days after surgery (Marcusa et al., 2017). Dental surgeries 7–10 million 93% of 81 patients prescribed American Dental Association Policy on (e.g., third molar procedures per year oxycodone following third molar Opioid Prescribing—Use nonopioids extraction) (Friedman, 2007; extraction used no postoperative as first-line therapy for acute dental Moore et al., 2006). pills, with 466 prescribed pills pain (ADA, 2018). unused or unfilled (Resnick et al., Approximately 2019). Bree Collaborative Dental Guideline 68% of all opioids on Prescribing Opioids for Acute Pain prescribed were Prior to implementing an opioid Management—Prescribe nonopioids as during surgical prescribing protocol for third first-line therapy (Bree Collaborative, dental visits (Gupta molar extractions, the mean 2017). et al., 2018). number of opioid pills per prescription was 15.9 in 2015, and Center for Opioid Research and in 2017, after implementation it Education Dental Opioid Guidelines— decreased to 11.5 (Tompach et al., NSAIDs as first-line therapy (CORE, 2019). 2018). continued

96 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Dionne Prescribing Opioid Analgesics for Acute Dental Pain: Time to Change Clinical Practices in Response to Evidence and Misperceptions—Provide a prescription of an opioid drug (3-day supply only) in combination with acetaminophen to be filled and administered only if needed for pain not relieved by regimen for moderately severe pain (Dionne et al., 2016). Wisconsin Best Practices for Prescribing Controlled Substances Guidelines—NSAIDs as first-line therapy. “Dentists should prescribe the lowest possible effective dosage. Dentists should avoid prescribing opioid doses >50 mg morphine equivalents per day” (Wisconsin, 2017). Washington State Opioid Prescribing Requirements—7-day opioid supply limit, unless clinically documented (Washington, 2018). Pennsylvania Guidelines on the Use of Opioid in Dental Practice—NSAIDs for first-line therapy. “If an opioid is to be administered, the dose and duration of therapy should be for a short period of time, and for conditions that typically are expected to be associated with more severe pain” (Pennsylvania, 2018). Michigan Acute Care Opioid Treatment and Prescribing Recommendations: Dental—“For breakthrough or severe pain, short-acting opioids (e.g., hydrocodone, oxycodone) should be prescribed at the lowest effective dose for no more than 3 to 5 day courses” (Michigan, 2018).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 97 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Extremity In 2014, 289,800 Of 81 children undergoing closed U.S. Department of Veterans trauma of 14.2 million reduction and percutaneous Affairs/U.S. Department of Defense requiring operating room pinning of a supracondylar Clinical Practice Guideline For surgery (e.g., procedures were humeral fracture, IQR of opioid Rehabilitation of Individuals with amputation, open for treatment use was 1–7 doses, patients used Lower Limb Amputation—For lower reduction and of fractures or 24.1% of prescribed opioids limb amputation “We suggest offering internal fixation) dislocations of (mean, 4.8 doses used and 19.8 a multi-modal, transdisciplinary the hip and femur doses prescribed) (Nelson et al., individualized approach to pain (2.0%) (McDermott 2019). management including transition to a et al., 2017). non-narcotic pharmacologic regimen Opioids prescribed after discharge combined with physical, psychological, In 2014, 518,700 for orthopedic fractures ranged and mechanical modalities throughout of 17.2 million from 20 to 655 mg oxycodone the rehabilitation process” (VA/DoD, ambulatory or pills; distal radius fractures 2017). inpatient surgeries received the least MMEs compared were for treatment with other fracture locations in Orthopaedic Trauma Association of fractures or opioid-naïve patients (Bhashyam Clinical Practice Guidelines for Pain dislocation of radius, et al., 2019). Management in Acute Musculoskeletal ulna, or lower Injury—For pain management in acute extremity other than musculoskeletal injury “prescribe the hip or femur (3.0%) lowest effective immediate release (Steiner et al., opioid dose for the shortest period 2017). possible” (Hsu et al., 2019). In 2014, 181,100 John Hopkins Opioid-Prescribing of 17.2 million Guidelines for Common Surgical ambulatory or Procedures: An Expert Panel inpatient surgeries Consensus—Developed consensus were for amputation ranges for outpatient opioid of a lower extremity prescribing at the time of discharge (1.0%) (Steiner et after 20 common procedures (Overton al., 2017). et al., 2018). 1/190 Americans American College of Occupational have loss of a limb and Environmental Medicine ACOEM (Ziegler-Graham et Practice Guidelines: Opioids for al., 2008). Treatment of Acute, Subacute, Chronic, and Postoperative Pain—“Opioids for treatment of acute, severe pain (e.g., crush injuries, large burns, severe fractures, injury with significant tissue damage) uncontrolled by other agents and/or with functional deficits caused by pain” (Hegmann et al., 2014). continued

98 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Joint In 2014, out At 1-month follow-up, of 115 American Academy of Orthopaedic replacement of 17.2 million patients undergoing spine or joint Surgeons—Clinical Practice (e.g., total hip ambulatory or surgery, 73% reported unused Guideline on Surgical Management arthroplasty inpatient surgeries, opioid pills, 46% had ≥20 unused of Osteoarthritis of the Knee—No [THA], total there were 789,500 pills, and 37% had ≥200 unused mention of opioid prescribing except knee arthroplasty knee arthroplasties MMEs (Bicket et al., 2019). to say opioid prescribing can be [TKA]) (4.5%), 546,000 reduced by using anesthesia such as (3.1%) partial or Out of 30,938 opioid-naïve nerve blocks (AAOS, 2015b). THA, and 154,800 patients undergoing TKA and (0.9%) arthroplasties 13,744 undergoing THA, 27% American Academy of Orthopaedic other than hip or of TKA patients and 38.5% of Surgeons—Information Statement: knee (Steiner et al., THA patients filled no opioid Opioid Use, Misuse, and Abuse in 2017). prescription after surgery (Cook et Orthopaedic Practice—“A prescription al., 2019). should only include the amount of In 2010, there were pain medication that is expected to be 2.5 million THA 304 opioid-naïve patients who used/appropriate, based on the protocol and 4.7 million TKA underwent THA or TKA were established. For patients who live (Kremers et al., randomized to receive either 30 longer distances from their surgeons, 2015). oxycodone immediate release two prescriptions for smaller amounts pills or 90 pills at discharge; at of opioids with specific refill dates Approximately 30 days after discharge, patients should be considered rather than a 680,000 knee who received 30 pills had a single large prescription” (AAOS, replacements yearly significantly lower median of 2015a). (Sloan et al., 2018). 15 (range, 0–30) unused pills compared to a median of 73 (range, 0–90) unused pills for those who received 90 pills (p<0.001). Within 90 days of discharge, significantly more (p<0.001) patients in the 30-pill group requested a refill compared to 90-pill group (Hannon et al., 2019). Opioids were overprescribed by more than 34% in TKA (n=51) and 140% in THA (n=48); median number of pills prescribed for 30 days was 90, median number of pills consumed was 67 (TKA) and 37 (THA); TKA patients had higher pain scores and were 5 times more likely to require a refill (Huang and Copp, 2019). 64.1% of 66 patients undergoing TKA stopped taking opioids within 6 weeks of surgery and had a mean equivalent of 18 oxycodone 5 mg pills remaining (Premkumar et al., 2019).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 99 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Laparoscopic In 2014, 2.6% Among 1,376 opioid-naïve John Hopkins Opioid-Prescribing abdominal of all inpatient patients undergoing laparoscopic Guidelines for Common Surgical procedures (e.g., surgeries were cholecystectomy, 96% received an Procedures: An Expert Panel appendectomy, cholecystectomy opioid prescription at discharge Consensus—Developed consensus bariatric surgery, and common duct with a median of 225 OMEs; 52% ranges for outpatient opioid cholecystectomy, exploration for a rate were prescribed more than the prescribing at the time of discharge colectomy, of 116.9/100,000 state draft guideline of 200 OMEs. after robotic retropubic prostatectomy hysterectomy, people (McDermott The 30-day refill rate was 5% or laparoscopic cholecystectomy prostatectomy); et al., 2017). (Hanson et al., 2018). (Overton et al., 2018). see also Open abdominal In 2014, out Among 2,392 patients undergoing Clinical Practice Guidelines for procedures of 17.2 million laparoscopic cholecystectomy, Enhanced Recovery After Colon and ambulatory or appendectomy, or hysterectomy, Rectal Surgery from the American inpatient surgeries, the median discharge prescription Society of Colon and Rectal 950,100 (5.5%) were was 150 OMEs (IQR, 135– Surgeons and Society of American cholecystectomy 225), equivalent to 30 pills of Gastrointestinal and Endoscopic and common bile hydrocodone/acetaminophen, Surgeons—“A multimodal, opioid- duct exploration, 5/325 mg; median use was only 30 sparing, pain management plan should 447,600 (2.6%) were mg (<10 pills), and 21% of those be used and implemented before the appendectomies, undergoing cholecystectomy took induction of anesthesia” (Carmichael 32,300 (0.2%) were no opioids. Patients undergoing et al., 2017). gastric bypass and laparoscopic colectomy were volume reduction prescribed a median of 40 pills, Friedman Postoperative Opioid surgery; and took a median of fewer than 10 Prescribing Practices and Evidence- 171,200 (1.0%) pills, and 34% took no opioids Based Guidelines in Bariatric were laparoscopic (Howard et al., 2018b). Surgery—Recommends outpatient gastrointestinal prescriptions of no more than 8–15 procedures (Steiner 170 patients who underwent pills after common bariatric surgical et al., 2017*). laparoscopic cholecystectomy procedures (Friedman et al., 2019). were compared with 200 patients It is estimated that who underwent the procedure after Hill Guideline for Discharge Opioid there were 228,000 a hospital intervention to reduce Prescriptions After Inpatient General bariatric surgeries opioid prescribing. Preintervention Surgical Procedures—Postdischarge in 2017 (ASMBS, patients were prescribed a median opioid use is best predicted by usage 2018). of 250 OMEs (IQR, 200–300), the day before discharge from inpatient equivalent to 40 5/325 mg laparoscopic colectomy or laparoscopic hydrocodone/acetaminophen pills; pancreatectomy (Hill et al., 2018a). median use was 30 OMEs (<10 pills); postintervention patients were prescribed a median of 75 OMEs (IQR, 75–112.5) and used 20 OMEs. There was no difference in pain scores between the groups (Howard et al., 2018c). continued

100 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication A median of 30 pills were prescribed to patients undergoing laparoscopic cholecystectomy and only about 32.7% of the pills were taken (Hill et al., 2017). Among 205 patients undergoing radical prostatectomy, a median of 225 mg OMEs were prescribed and 22.5 mg used, overall 77% of postdischarge opioid medication was unused, with 84% of patients requiring ≤112.5 mg OMEs (Patel et al., 2019). Among patients undergoing laparoscopic prostatectomy, or minimally invasive (i.e., laparoscopic or robotic) partial or radical nephrectomy, the median OME prescribed was 27 for each procedure and the median use (IQR) was 8 (6–20) for minimally invasive nephrectomy and 4 (1–15) for robotic-assisted laparoscopic prostatectomy; overall 60% of the prescribed pills were unused (Theisen et al., 2019). Among 1,892 patients without baseline opioid use prior to bariatric surgery, postoperative opioid use increased from 5.8% (95% CI 4.7–6.9) at 6 months to 14.2% (95% CI 12.2–16.3) at year 7 (King et al., 2017). After discharge following laparoscopic bariatric surgery, 68 patients were prescribed 1,921 opioid pills total; the mean number of pills taken was 650 (33.8%) and 4.4% requested refills (Hill et al., 2018a).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 101 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Laparoscopic or In 2014, out of 17.2 Following inguinal/femoral or Society of American Gastrointestinal open abdominal million ambulatory open incisional hernia repair, the and Endoscopic Surgeons Guidelines wall procedures or inpatient median OMEs prescribed were for Laparoscopic Ventral Hernia (e.g., femoral surgeries, 477,400 150 (IQR, 135–225; equivalent Repair—“Persistent pain following hernia, incisional (2.8%) were inguinal to 30 pills of hydrocodone/ laparoscopic ventral hernia repair hernia, inguinal and femoral hernia acetaminophen, 5/325 mg); should be treated with analgesics, anti- hernia) repair, and 614,200 median use was 30 mg (<10 pills) inflammatory medications, steroids, (3.5%) were other for inguinal/femoral repair, and trigger point injection or nerve block” hernia repairs approximately 15 pills for open (Earle et al., 2016). No specific (Steiner et al., incisional repair (Howard et al., mention of opioids. 2017). 2018b). John Hopkins Opioid-Prescribing Among 27 patients undergoing Guidelines for Common Surgical laparoscopic or open ventral Procedures: An Expert Panel hernia repair, 639 opioid pills Consensus—Developed consensus were prescribed of which 53.4% ranges for outpatient opioid were taken (Hill et al., 2018a). prescribing at the time of discharge after laparoscopic or open inguinal 39,297 patients received a median hernia repair, unilateral or umbilical initial opioid pain prescription of hernia repair (Overton et al., 2018). 6 days following laparoscopic or open inguinal hernia repair and The HerniaSurge Group International 14.3% received one or more refills Guidelines for Groin Hernia (Scully et al., 2018). Management—“Opioids can be used for moderate- or high-intensity pain, Patients undergoing laparoscopic in addition to non-opioid analgesia or or open inguinal hernia repair when the combination of an NSAID were prescribed a median of 30 and paracetamol is not sufficient or is opioid pills and took 14.5% and contraindicated” (Simons et al., 2018). 31.1% of pills, respectively (Hill et al., 2017). Hill Guideline for Discharge Opioid Prescriptions After Inpatient General In pediatric patients, postoperative Surgical Procedures—Postdischarge opioid prescriptions were opioid use is best predicted by usage significantly reduced for hernia the day before discharge from inpatient repair following an educational laparoscopic or open ventral hernia intervention: 4.2±2.9 versus repair (Hill et al., 2018a). 2.7±2.6 days’ supply (p=0.004) (Horton et al., 2019b). continued

102 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Obstetric Cesarean sections Of 165 women who had cesarean The American College of Obstetricians surgeries (e.g., were the most deliveries, 83% filled an opioid and Gynecologists ACOG cesarean delivery, frequent operating prescription (median 225 MMEs Committee Opinion: Postpartum vaginal delivery) room procedure in prescribed) and 75% had unused Pain Management—Contains 2014, with 1,242,800 pills (median 75 MMEs) at 2 recommendations on the use of opioids procedures out of weeks postpartum (Osmundson et for postpartum pain and at discharge 14,198,000 inpatient al., 2017). from the hospital and types of opioids procedures, for to be used in stepped care (ACOG, an incidence of Of 308,226 deliveries, 27% of 2018a). 389.8/100,000 women with vaginal deliveries and people (McDermott 75.7% of women with cesarean John Hopkins Opioid-Prescribing et al., 2017). deliveries filled peripartum opioid Guidelines for Common Surgical prescriptions (Peahl et al., 2019). Procedures: An Expert Panel 3,855,500 births Consensus—Developed consensus annually; 32% Of 1.3 million women who had ranges for outpatient opioid cesarean; 68% vaginal deliveries, 28.5% were prescribing at the time of discharge for vaginal; 9% have prescribed an opioid (median uncomplicated vaginal and cesarean severe perineal dose 150 MMEs) within 1 week delivery (Overton et al., 2018). laceration; 2.6 of discharge; 8.5% of women million vaginal filled ≥1 opioid prescriptions 6 Mills Draft Opioid-Prescribing deliveries annually weeks after delivery (Prabhu et al., Guidelines for Uncomplicated (ACOG, 2018a; 2018). Normal Spontaneous Vaginal Birth— Martin et al., “Nonpharmacologic therapy and 2018a). Of 30 patients undergoing nonopioid pharmacologic therapy cesarean sections, 53% reported are preferred for patients undergoing In 2017, there were taking either no or very few (less normal spontaneous vaginal delivery 1,232,339 cesarean than 5) prescribed opioid pills; with no complications. Clinicians deliveries and 83% reported taking half or less; should consider opioid therapy only 2,621,010 vaginal and 17% of women reported if expected benefits for both pain and deliveries (Martin et taking all or nearly all (5 or fewer function are anticipated to outweigh al., 2018a). pills left over) (Bartels et al., risks to the patient. If opioids are 2016). used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate” (Mills et al., 2019).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 103 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Open abdominal In 2014, 508,700 104 patients undergoing open Society of Gynecologic Surgeons procedures (e.g., (~3.0%) of 17.2 colectomy were prescribed Preemptive Analgesia for Postoperative appendectomy, million ambulatory a median of 40 5/325 mg Hysterectomy Pain Control: Systematic cholecystectomy, or inpatient surgeries hydrocodone/acetaminophen pills Review and Clinical Practice colectomy, were abdominal and took a median of fewer than Guidelines—“If using narcotics, we hysterectomy); and vaginal 15 pills (Howard et al., 2018b). suggest using higher preemptive see also hysterectomies doses to result in lower postoperative Laparoscopic (Steiner et al., After laparoscopic, open, or narcotic requirements” (Steinberg et abdominal 2017). robotic colectomy, 69 patients al., 2017). procedures were prescribed 1,022 opioid In 2014, out pills total at discharge; the mean John Hopkins Opioid-Prescribing of 17.2 million number of pills taken was 201 Guidelines for Common Surgical ambulatory or (19.7%) and 2.9% requested Procedures: An Expert Panel inpatient surgeries, refills; after hepatectomy Consensus—Developed consensus 950,100 (5.5%) were or laparoscopic or open ranges for outpatient opioid cholecystectomy pancreatectomy, patients used prescribing at the time of discharge and common bile 53.6% and 37.3%, respectively, of for open or minimally invasive duct exploration, their prescribed opioids (Hill et hysterectomies (Overton et al., 2018). 447,60 (2.6%) were al., 2018a). appendectomies, ACOG Committee Opinion 32,300 (0.2%) were Of TRICARE beneficiaries Perioperative Pathways: Enhanced gastric bypass and who underwent an open or Recovery After Surgery—Oral volume reduction laparoscopic appendectomy, 13.6% opioids if needed; breakthrough pain surgery, and requested a refill; among those hydromorphone (ACOG, 2018b). 9,950,759 were open with an open or laparoscopic (Note: Specific surgical procedures are abdominal surgery cholecystectomy, 11.3% requested not given.) (Steiner et al., a refill; and among those with 2017). an open, vaginal, or laparoscopic Society for Surgery of the Alimentary hysterectomy, 17.3% requested Tract (SSAT) Evidence-Based Between 2009 a refill. All refill requests were Current Surgical Practice: Calculous and 2013, there made within 7–8 days of the initial Gallbladder Disease—No mention of were nearly 10 prescription (Scully et al., 2018). opioids (Duncan and Riall, 2012). million discharges associated with open Among patients undergoing Hill Guideline for Discharge Opioid abdominal surgery open nephrectomy or radical Prescriptions After Inpatient General (Carney et al., prostatectomy, the median OME Surgical Procedures—Postdischarge 2017). prescribed was 27 for each opioid use is best predicted by procedure, and median use (IQR) usage the day before discharge from was 14 (2–22) and 9 (4–23), inpatient open pancreatectomy or open respectively; overall 60% of pills colectomy (Hill et al., 2018a). prescribed went unused (Theisen et al., 2019). continued

104 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Oropharyngeal In 2014, out Of 64 patients who underwent American Academy of procedures (e.g., of 17.2 million tonsillectomy, 67.2% reported Otolaryngology–Head and Neck tonsillectomy) ambulatory or unused opioids; mean MME Surgery Clinical Practice Guideline: inpatient surgeries, prescribed per day was 74.1±44.8, Tonsillectomy in Children (Update)— 383,300 (2.2%) were with a mean MME used per If opioids are used in the immediate tonsillectomy and/ day of 49.2±34.3, resulting in postoperative period, they should be or adenoidectomy 228.1±208.5 MMEs remaining per used at reduced doses with careful (Steiner et al., patient (Choo et al., 2019). titration and continuous pulse 2017). oximetry. Studies have demonstrated After an educational intervention that NSAIDs decrease postoperative 339,000 ambulatory for providers, there was no pain, nausea, and vomiting and are tonsillectomies in reduction in the amount of opioids a “viable alternative to opioids. 2010 (Kou et al., prescribed for pediatric patients Clinicians must not administer or 2019). undergoing tonsillectomy: 6.3±4.4 prescribe codeine, or any medication versus 5.4±3.0 days’ supply containing codeine, after tonsillectomy (p=0.226) (Horton et al., 2019b). in children younger than 12 years” (Mitchell et al., 2019). John Hopkins Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus—Developed ranges for outpatient opioid prescribing at the time of discharge for partial or total thyroidectomy or for cochlear implant (Overton et al., 2018).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 105 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Spine procedures 3.3% of all inpatient After implementation of an opioid ACOEM Practice Guidelines: (e.g., fusion surgical procedures prescribing guideline, the mean Opioids for Treatment of Acute, in both adults in 2014 were spinal amount of opioids prescribed after Subacute, Chronic, and Postoperative and children, fusions, for a rate lumbar spine surgeries dropped Pain—Routine use of opioids for laminectomy) of 145.3/100,000 from 629 OMEs (81 pills) to 490 treatment of acute pain is strongly people; 3.1% were OMEs (66 pills); the mean number not recommended. Opioids may be laminectomies, of prescribed pills also decreased used for treatment of acute, severe 137.4/100,000 (81 versus 66, p<0.001); however, pain (e.g., crush injuries, large burns, people (McDermott refill rates within 6 weeks were severe fractures, injury with significant et al., 2017). higher (7.6% versus 12.4%, tissue damage) uncontrolled by other p<0.07) (Lovecchio et al., 2019). agents and/or with functional deficits In 2014, out of 17.2 caused by pain. “The maximum daily million ambulatory Of 16,647 TRICARE patients oral dose recommended for opioid- or inpatient undergoing discectomy, 30.1% naïve, acute pain patients based on risk surgeries, 500,900 required ≥1 opioid refills (Scully of overdose/death is 50-mg MED.” (2.9%) were spinal et al., 2018). Recommend taper off opioid use in 1 fusions (Steiner et to 2 weeks (Hegmann et al., 2014). al., 2017). Of 81 patients undergoing spine or joint surgery, at 1-month postsurgery, 73% reported having unused opioid pills, 46% had ≥20 unused pills, and 37% had ≥200 MMEs (Bicket et al., 2019). Between 2007 and 2014, opioid prescribing in the first 30 days after a laminectomy varied dramatically across states from fewer than 2,000 MMEs in most states to more than 2,000 MMEs in 10 states (73,176 patients) (Vail et al., 2018). continued

106 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Sports-related In 2014, out 100 patients undergoing shoulder John Hopkins Opioid-Prescribing procedures (e.g., of 17.2 million surgery (rotator cuff repair, labral Guidelines for Common ACL repair and ambulatory or repair, stabilization/Bankart repair, Surgical Procedures: An Expert reconstruction, inpatient surgeries, debridement) received 60 opioid Panel Consensus—Developed joint arthroscopy, 106,700 (0.6%) pills at discharge; at postoperative consensus ranges for outpatient rotator cuff were arthroscopic day 90, the total number of opioid prescribing at the time of repair) procedures and prescribed pills was 4,480, the discharge after arthroscopic partial 1,050,900 (6%) were total number of unused pills was meniscectomy, arthroscopic ACL/ therapeutic surgical 1,628, and an overall median of PCL repair, arthroscopic rotator cuff procedures on 13 pills remained (Kumar et al, repair, and open reduction and internal muscle, tendon, and 2017). fixation of the ankle (Overton et al., soft tissue (Steiner 2018). et al., 2017). Among 16,511 TRICARE patients undergoing ACL repair and 14,840 American College of Occupational Rate of ACL undergoing rotator cuff repair, and Environmental Medicine ACOEM reconstruction 39.3% and 36.0%, respectively, Practice Guidelines: Opioids for increased 22%, from required ≥1 opioid refill (Scully et Treatment of Acute, Subacute, Chronic, 61.4/100,000 person- al., 2018). and Postoperative Pain—Opioids for years in 2002 to treatment of acute, severe pain (e.g., 74.6/100,000 person- At 3 months after ACL crush injuries, large burns, severe years in 2014; reconstruction, 7.24% of 4,946 fractures, injury with significant tissue highest rates were patients were still filling opioid damage) uncontrolled by other agents among adolescents prescriptions (Anthony et al., and/or with functional deficits caused aged 13–17 (Herzog 2017). by pain (Hegmann et al., 2014). et al., 2018). Among 70 patients who Orthopaedic Trauma Association underwent a preoperative opioid Clinical Practice Guidelines for Pain education intervention, there Management in Acute Musculoskeletal was a statistically significant Injury—Prescribe the lowest effective decrease in opioid consumption immediate release opioid dose for the at 2 weeks (average 19%, p=0.1), shortest period possible (Hsu et al., 6 weeks (33%, p=0.02), and 3 2019). months (42%, p=0.01) follow-up compared with controls (Syed et AAOS Management of Anterior al., 2018). Cruciate Ligament Injuries Evidence- Based Clinical Practice Guideline— No mention of opioids (AAOS, 2014a). AAOS Management of Rotator Cuff Injuries Evidence-Based Clinical Practice Guideline—“Moderate strength evidence supports the use of multimodal programs or nonopioid individual modalities to provide added benefit for postoperative pain management following rotator cuff repair” (AAOS, 2019).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 107 TABLE 5-2 Continued Criteria for Developing Clinical Practice Guidelines Selected Examples of Available Evidence of Variation in Guidelines That Address Opioid Procedure Groups Prevalence of Prescribing or Over- or Under- Prescribing for Acute Pain for the and Examples Procedure Prescribing Specific Indication Pennsylvania The Safe Prescribing of Opioids in Orthopedics and Sports Medicine—“Opioids should rarely be used as the only analgesic. Pain care can include non-opioid medications, regional anesthesia, and various modalities of therapeutic and supportive care.” Opioids should be limited to 7-day dosage in some situations according to 2016 Pennsylvania laws (Pennsylvania, 2017). Thoracic Pectus chest Among children undergoing John Hopkins Opioid-Prescribing procedures (e.g., deformities occur inpatient surgery, the median Guidelines for Common Surgical thoracoscopy, in approximately number of opioid doses dispensed Procedures: An Expert Panel repair of pectus 1 of every 300 to was 43 (IQR, 30–85 doses) with Consensus—Developed consensus excavatum in 400 white male a median duration of 4 days ranges for outpatient opioid children [Nuss births and occurs (IQR, 1–8 days); children who prescribing at the time of discharge for procedure]) 5 times more often underwent orthopedic or Nuss video-assisted thoracoscopic wedge in men than women surgery consumed 25.42 (95% resection (Overton et al., 2018). (Jaroszewski et al., CI 19.16–31.68) more doses than 2010). those who underwent other types of surgery (p<0.001). Overall 58% The prevalence of (95% CI 54–63%) of doses were pectus excavatum not consumed (Monitto et al., is 2.6% in children 2017). ages 7 to 14 yrs (Abdullah and Among 31 patients undergoing Harris, 2016). thoracic surgery, 45% reported taking either no or very few (5 or less) prescribed opioid pills; 71% reported taking half or less; and 29% of patients reported taking all or nearly all (5 or fewer pills left over) of their opioid prescription (Bartels et al., 2016). * For most inpatient or ambulatory surgeries, Steiner et al. (2017) do not indicate whether the surgery was open or laparoscopic; where the type of surgery was specified this is reported. NOTE: ACL=anterior cruciate ligament; CI=confidence interval; CPG=clinical practice guideline; IQR=interquartile range; MME=morphine milligram equivalent; NSAID=nonsteroidal anti-inflammatory drug; OME=oral morphine equivalent; THA=total hip arthroplasty; TKA=total knee arthroplasty.

108 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN MEDICAL INDICATIONS OVERVIEW Acute pain may be ascribed to a number of medical conditions, ranging from relatively common conditions such as back pain to less frequently occurring conditions such as sickle cell disease. How- ever, in contrast to the burgeoning literature on the use of opioids to treat postoperative or procedural pain, there is less evidence about opioid prescribing for specific medical conditions, about the over- and under-prescribing of opioids for those conditions, and about the outcomes for different opioid prescrib- ing strategies. The time course of resolution for medical conditions that produce acute pain is variable, and it depends on the etiology of the pain; the natural history of acute pain in the condition; patient factors, such as comorbidities, tolerance, and expectations of pain; and whether definitive treatment is available and used. Furthermore, in some conditions for which opioids are not a first-line treatment, certain patients may not have the expected alleviation of pain by nonopioid treatments (David Jevsevar, Dartmouth Geisel School of Medicine, presentation to committee, July 9, 2019). For such patients, prescribing opioids as a second-line treatment approach may be indicated. Opioid prescribing for acute pain for medical conditions may occur in primary care clinics, emergency departments (EDs), inpatient hospital settings, and specialty practices such as pain clinics and practices devoted to rheumatology, urology and nephrology, neurology, or orthopedics. Kea et al. (2016) found that the pain-related diagnoses for which opioids were most frequently prescribed in the ED were renal stones (62% of patients received an opioid prescription), neck pain (52%), dental/jaw pain (50%), fracture (49%), cholelithiasis (48%), and back pain (45%). Conversely, among patients prescribed an opioid in the ED, the six most common pain-related diagnoses were non-fracture injuries (29%), back pain (10.5%), fractures (9.5%), abdominal pain (8.3%), dental/jaw pain (6%), and headache (4%). Hudgins et al. (2019) examined trends in opioid prescribing for adolescents and young adults in ambulatory care settings from 2005 to 2015 using data from the National Hospital Ambulatory Medical Care Survey (NHAMCS) and the National Ambulatory Medical Care Survey (NAMCS). They found that 5.2% of visits were associated with an opioid prescription, of which nearly 56% were provided in EDs and another 43% were provided in outpatient clinics. The rates of opioid prescribing were the highest for ED visits by young adults. The most common diagnoses resulting in an opioid prescription in the ED were dental pain and acute injuries among adolescents and dental pain and low back pain among young adults. In another study that examined opioid prescribing in 19 EDs during 1 week in 2012, there were 19,321 discharges, of which 17.0% received an opioid prescription. The 10 most common diagnoses associated with a discharge opioid prescription were musculoskeletal back pain (10.2%), abdominal pain (10.1%), extremity fracture (7.1%), extremity sprain (6.5%), dental/oral issue (6.2%), other extremity pain (5.8%), nephrolithiasis (4.5%), skin contusion (3.9%), chest pain (including non-cardiac; 3.3%), and closed head injury (3.0%) (Hoppe et al., 2015b). Mundkur et al. (2019) characterized patterns of opioid analgesic use for acute pain in primary care settings using commercial insurance claims data from 2014. They found that in 2014, 9.1% of patients presenting at their first visit for pain began opioids at that visit. The rate of initiation varied substantially by the reason for the pain; in this study, patients with a history of prior opioid fills were excluded. Among patients with an acute pain complaint, nearly 8% filled an opioid prescription. The authors examined 10 common acute pain conditions selected on the basis of the frequency of their occurrence in the authors’ dataset. The conditions, in order of descending prevalence, were joint pain (4.9% filled an opioid prescription); back pain without radiculopathy (13.4% filled an opioid prescription); headache (3.5% filled an opioid prescription); neck pain (9.2% filled an opioid prescription); tendonitis/bursitis (3.4% filled an opioid prescription); muscle strain/sprain (9% filled an opioid prescription); back pain with radiculopathy (17.4% filled an opioid prescription); renal stones (14.2% filled an opioid prescription);

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 109 musculoskeletal injury (e.g., ligament tear) (5.8% filled an opioid prescription); and dental pain (27.6% filled an opioid prescription). The authors found that the initial opioid prescription duration was not consistently associated with refill rate, suggesting that for these common medical conditions opioids may be overprescribed. Thus, opioid prescribing for acute medical conditions, like postsurgical care, requires a health care provider’s judgment regarding the appropriate dose and duration of opioid. Chung et al. (2018) analyzed outpatient opioid prescription data among children and adolescents enrolled in Tennessee Medicaid from 1999 to 2014. The annual mean prevalence of opioid prescriptions was 15%. The conditions most commonly associated with an opioid prescription were dental procedures (31.1% prescriptions), outpatient procedure or surgery (25.1%), trauma (18.1%), and infections (16.5%). One out of every 2,611 opioid prescriptions (437 of 1,362,503 total prescriptions) was related to an opioid-adverse event; 71.2% of the adverse events were related to the therapeutic use of the opioid versus abuse or intentional harm. Methods for Identifying Priority Medical Conditions for Clinical Practice Guideline Development The committee used several approaches to identify medical indications for priority CPG develop- ment. To prioritize medical conditions for CPG development, the committee selected and considered the same key factors (see Box 5-1) that it used to prioritize surgical procedures, for example, the prevalence of the condition, evidence of over-prescribing or under-prescribing of opioids for the condition, and the lack of a CPG or an evidence-based CPG. The committee began by reviewing a Centers for Disease Control and Prevention (CDC) data analysis of the 2016 NHAMCS ED diagnoses that are associated with a discharge opioid prescription for acute pain (Schappert and Rui, 2019). The committee asked CDC to provide a list of the primary diagnoses for all ED visits at which opioids were prescribed at discharge. The committee then reviewed the literature to identify data on opioid prescribing in the primary care setting. Although there were numerous studies that looked at opioid prescribing for individual medical indications, the committee found two published studies that examined the prevalence of medical con- ditions and associated opioid prescriptions for acute pain and thus were useful in prioritizing medical indications for the purposes of the committee. One study analyzed data from NAMCS on opioid pre- scribing in the primary care setting (Sherry et al., 2018). NAMCS is a national, annual survey of visits made to nonfederally employed, office-based physicians who are primarily engaged in direct patient care and of visits to community health centers; the survey collects information on patient, provider, and visit characteristics (CDC, 2019). Another useful study analyzed administrative data from Optum’s Clinfor- maticsTM DataMart on the prevalence of medical conditions and associated opioid prescriptions in the primary care setting (Mundkur et al., 2019). This database is derived from commercial insurance claims that contains a combination of inpatient and outpatient claims, pharmacy dispensing information, and patient demographics routinely collected during health insurance enrollment. In addition, the committee received input from a variety of experts at its public session on priority medical and surgical conditions to be considered for CPG development. Finally, the committee used the expertise of its members not only to review the medical indications that were relatively prevalent and strongly associated with opi- oids, but also to identify less common medical indications related to acute pain that might be worthy of CPG development based on such factors as evidence of under-prescribing, disproportionate impact on certain populations (e.g., children and adolescents, minorities, older adults), or a strong association with over-prescribing and opioid misuse.

110 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN The committee further refined the list of medical indications by removing indications that were overly broad, such as undifferentiated abdominal pain, neck pain, and chest pain. In the committee’s judgment it would be difficult to develop an evidence-based CPG at present for such poorly defined indications because their causes can be diverse or unknown and numerous medical specialties may be involved in treating the indication, making it difficult to direct the CPG to a specific medical practice area. For example, in the Mundkur et al. (2018) study, 27 International Classification of Diseases, Ninth Edition codes were used to identify neck pain. Preliminary literature searches for these broadly termed indications did not result in substantive articles on the prevalence of the indication and opioid prescribing patterns for the indication. The lack of specific evidence for these indications made them poor candidates for the committee’s task. Of note, the issue of the prevalence of opioid prescribing and the relative distribution of medical conditions in which opioids are prescribed is not consistently studied, as different investigators do not always describe their selection of conditions to consider or define the painful conditions in exactly the same way. In addition, the terminology used to describe and categorize medical conditions is inconsistent across studies. Therefore, the committee grouped related terms together—for example, the committee considered low back pain (the term it uses) to include lumbago, back pain, backache, unspecified dorsalgia, and unspecified low back pain—all of them with or without radiculopathy. This variation in terminology and selection criteria added to the difficulty in determining both prevalence and opioid prescribing practices for an indication. After the list of potential medical indications was developed, the committee sought evidence on prescribing opioids for each indication. This search was not exhaustive, but rather it focused on recent literature that demonstrated that opioids were prescribed for the indication in the ED, primary care setting, or other health care clinic outside of a surgical setting. For those conditions for which such evidence was available, the committee then sought some evidence of over- or under-prescribing, as such evidence would suggest that evidence-based CPGs might reduce inappropriate practice variation. In addition, the committee sought evidence of new chronic opioid use in opioid-naïve patients who received an opioid prescription for the acute indication. Again, this search was not extensive; a single, well-conducted study showing data on leftover pills or refills was deemed to be sufficient to show that over- or under-prescribing had occurred and that the area warranted further investigation. Finally, the committee considered whether there was a guideline available on prescribing opioids for acute pain associated with the selected indications. A literature search was conducted to identify any such guidelines (see Appendix B). Although there is considerable guidance available for some indications, little is specific for acute pain or opioid prescribing. Thus, as with surgical procedures, the committee did not identify any CPGs that contain specific recommendations for prescribing opioids to treat acute pain for the specific priority medical indications identified by the committee, although several of them do provide guidances on opioid therapy in the ED or inpatient settings (e.g., NHBLI, 2014). The committee has indicated what guidelines exist and their specificity in Table 5-3. Based on the above information, the committee recommends that CPGs for opioid prescribing be considered for the following medical conditions (see Table 5-3). • Dental pain (non-surgical) • Fractures • Low back pain (includes lumbago, dorsalgia, backache) • Migraine headache • Renal stones (also called kidney stones, nephrolithiasis, calculus of the kidney, renal colic) • Sickle cell disease • Sprains and strains, musculoskeletal • Tendonitis/bursitis

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 111 TABLE 5-3  Opioid Prescribing Patterns for Selected Medical Indications Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Dental pain (non- Approximately The opioid prescription rate No evidence-based CPG available. surgical) 31% of all per 1,000 dental patients opioids prescribed increased from 130.58 in American Academy of Pediatric Dentistry for dental 2010 to 147.44 in 2015; Policy on Acute Pediatric Dental Pain patients were for those aged 11–18 Management—Nonopioid analgesics as for nonsurgical years opioid prescriptions first-line agents for pain management; dental visits, increased from 99.71 in 2010 combining opioid analgesics with NSAIDs mostly restorative to 165.94 in 2015; median or acetaminophen for moderate/severe pain procedures; opioid day supply was 3 days with may decrease overall opioid consumption prescription rate a median daily dose of 33.33 (AAPD, 2018). in 2015 for all MMEs for all age groups, dental patients but was 37.50 MMEs for American Dental Association Policy on was 147.44/1,000 ages 19–25 years and 36.00 Opioid Prescribing—Supports statutory patients. In 2012, for ages 11–18 years (Gupta limits on opioid dosage and duration of dentists prescribed et al., 2018). no more than 7 days for acute pain (ADA, 6.4% of opioids in 2018). the United States Before the implementation (Gupta et al., of a hospital ED opioid Michigan Opioid Prescribing Engagement 2018). prescribing guideline Network Acute Care Opioid Treatment and in Maine, the opioid Prescribing Recommendations: Summary of In 2016, there were prescribing rate for dental Selected Best Practices—For breakthrough 1.68 million visits pain was 59%; after or severe pain, short-acting opioids (e.g., to EDs with a implementation the rate was hydrocodone, oxycodone) should be primary diagnosis 42% (Fox et al., 2013). prescribed at the lowest effective dose for of diseases of no more than 3- to 5-day courses (Michigan, the teeth and In 2016, 53.8% of all 2018). supporting patients in the ED with structures a primary diagnosis of Washington State Opioid Prescribing (Schappert and diseases of the teeth and Requirements for Dentists—Seven-day opioid Rui, 2019). supporting structures supply limit, unless clinically documented were prescribed opioids at (Washington, 2018). discharge (Schappert and Rui, 2019). Wisconsin Dentistry Examining Board Best Practices for Prescribing Controlled Substances Guidelines—Lowest possible effective dosage; avoid prescribing opioid doses >50 mg MME/d; recognize that opioid doses ≥90 mg MME/d dramatically increase risk and therefore require justification and documentation (Wisconsin, 2017). continued

112 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Fractures In Olmstead Of 4,600 patients who No evidence-based CPG or other guidelines County, Minnesota, received nonsurgical available. between 2009– treatment for ankle fracture, 2011 there was a 48.8% had filled at least There are CPGs that focus on surgery for fracture incidence one opioid prescription, hip fractures in adults (AAOS, 2014b; NICE, of 2,704/1000,000 and 7.4% of them had 2017). person-years in new, persistent opioid use residents aged ≥50 at 6 months posttreatment years (Amin et al., (Gossett et al., 2019). 2014). Postgraduate second-year Age-related (i.e., residents prescribed more osteoporosis) opioid doses to pediatric ED fractures in people patients with acute injuries, ≥50 years of age of which 71% were fractures are projected to than did other residents increase nationally or nonresident prescribers from ≥2 million in (Kahl et al., 2019). 2005 to ≥3 million fractures in 2025 In 2016, discharge opioid (Burge et al., prescriptions were provided 2007). to between 33–53% of ED patients diagnosed with a In 2016, 2.5% traumatic fracture (Schappert of all ED and Rui, 2019). visits were for traumatic fractures (Schappert and Rui, 2019). Low back pain Among office Opioids were prescribed American College of Physicians Systemic visits with a pain at discharge for 603,000 Pharmacologic Therapies for Low Back diagnosis at which (45.5%) ED visits for low Pain: A Systematic Review for an American opioids were back pain and at 968,000 College of Physicians Clinical Practice prescribed between (33.5%) ED visits for other Guideline—No evidence to support the use 2006–2015, 6.9% conditions of the spine and of opioids for acute low back pain (Chou et were prescribed for back (Schappert and Rui, al., 2017). lumbago and 3.7% 2019). were prescribed American College of Physicians Noninvasive for unspecified Treatments for Acute, Subacute, and backache (Sherry Chronic Low Back Pain: A Clinical Practice et al., 2019). Guideline from the American College of Physicians—As most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment (Qaseem et al., 2017).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 113 TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Back symptoms Opioid prescribing for low Kaiser Permanente Non-specific Back Pain were the fifth back pain was less prevalent Guideline—Opioids are rarely indicated most common in the Northeast (33%) for the treatment of back pain. Opioid reason for an ED than in other regions of the prescriptions for acute back pain, if made, visit in 2016, and United States (41%, 43%, should be limited to 3 days and follow-up comprised 2.5% of 44% in the Midwest, South, with the patient (Kaiser Permanente, 2017). all ED visits (Rui and West, respectively, et al., 2016). p=0.001) (Morris et al., Institute for Clinical Systems Improvement 2019). Health Care Guideline: Adult Acute and In 2016, 0.9% Subacute Low Back Pain—Opioids are not (1.3 million visits Among 23 ED prescribers recommended for acute and subacute low of 145.6 million discharging patients with low back pain; if nonopioid options have been total ED visits) of back pain, there was a 6-fold tried and unsuccessful, the first opioid patients received variation in the adjusted, prescription for acute pain should be the a diagnosis of risk-standardized prescribing lowest possible effective strength of a short- unspecified low rates that ranged from 12.0% acting opioid, not to exceed 100 MMEs back pain and to 78.2% (mean 50.4% total. Patients should be instructed that 3 about 2% received [standard deviation +/–16.4]) days or less will often be sufficient (ICSI, a diagnosis for (Morris et al., 2019). 2018). other conditions of the spine and back, American College of Emergency Physicians excluding low back Clinical Policy: Critical Issues in the pain (Schappert Prescribing of Opioids for Adult Patients in and Rui, 2019). the Emergency Department—If opioids are indicated, the prescription should be for the lowest practical dose for a limited duration (e.g., <1 week), and the prescriber should consider the patient’s risk for opioid misuse, abuse, or diversion (Cantrill et al., 2012). Migraine headache 1-year period In 2016, 0.4% of ED patients American Academy of Neurology Practice prevalence of who received a discharge Parameter: Evidence-Based Guidelines for migraines is about prescription for opioids Migraine Headache (an Evidence-Based 18% in women had a primary diagnosis of Review): Report of the Quality Standards and 6% in men; migraine (Schappert and Rui, Subcommittee of the American Academy of prevalence peaks 2019). Neurology—“Butorphanol nasal spray for between the ages some migraines; parenteral opiates as rescue of 25 and 55 therapy for acute migraine if sedation side (AHS, 2019). effects not a risk” (Silberstein, 2000). continued

114 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication In 2016, there A migraine treatment American Academy of Neurology Evidence- were more than 4 algorithm for ED clinicians Based Guideline Update: Pharmacologic million visits to reduced the number of Treatment for Episodic Migraine Prevention EDs for headaches patients discharged with in Adults. Report of the Quality Standards (although not opioid prescriptions from Subcommittee of the American Academy specifically for 37% to 12.2% (p=0.008) of Neurology and the American Headache migraines) (Rui et within 6 months of the Society—Does not mention opioids al., 2016). implementation of the (Silberstein et al., 2012). algorithm with further reductions in opioid American Academy of Neurology Practice prescribing to 6% 1 year Guideline Update Summary: Acute Treatment after implementation of Migraine in Children and Adolescents— (Ahmed et al., 2017). “No more than 9 days per month of any combination of triptans, analgesics, or opioids for more than 3 months to avoid medication overuse headache. There is no evidence to support the use of opioids in children with migraine. Opioids are included in this statement to be consistent with the International Classification of Headache Disorders regarding medication overuse” (Oskoui et al., 2019). American Headache Society The American Headache Society Position Statement on Integrating New Migraine Treatments into Clinical Practice—Recommends against use of opioid, specifically butorphanol (AHS, 2019). Institute for Clinical Systems Improvement Health Care Guideline: Diagnosis and Treatment of Headache—Avoid the use of opiates and barbiturates in the treatment of headache (Beithon et al., 2013). Institute of Health Economics, Alberta, Canada, Primary Care Management of Headache in Adults: Clinical Practice Guideline—“Opioid analgesics (e.g., codeine, tramadol) and combination analgesics containing opioids are not recommended for routine use for the treatment of migraine because of their potential for causing medication-overuse headache. Opioids may be necessary when other medications are contraindicated or ineffective, or as a rescue medication when the patient’s usual medication has failed” (IHE, 2016).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 115 TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Renal stones Based on 2007– An ED opioid-reduction American Urology Association Medical 2010 NHANES, initiative reduced discharge Management of Kidney Stones: AUA overall prevalence opioid prescribing by 25.5% Guideline—No mention of opioids (Pearle et of renal stones (95% CI 22.26–28.72), from al., 2014). was 8.8% (95% CI 68.6% in the 2012–2014 8.1–9.5), 10.6% preimplementation phase American College of Physicians Dietary among men (95% to 43.1% in the 2015–2017 and Pharmacologic Management to Prevent CI 9.4–11.9), and postimplementation phase Recurrent Nephrolithiasis in Adults: A 7.1% (95% CI (Motov et al., 2018). Clinical Practice Guideline from the 6.4–7.8) among American College of Physicians—No women (Scales et In 2016, 63.7% of ED mention of opioids (Schappert and Rui, al., 2012). patients with a primary 2019). diagnosis of calculus of the In 2016, there were kidney or ureter received a European Association of Urology 981,000 visits to discharge prescription for Urolithiasis Guidelines—Offer opiates the ED for calculus opioids (625,000/981,000) (hydromorphine, pentazocine, or tramadol) of the kidney and (Schappert and Rui, 2019). as a second choice (Türk et al., 2016). ureter (Schappert and Rui, 2019). Sickle cell disease It is estimated that In 2009–2014, opioids National Heart, Lung, and Blood Institute (SCD) 100,000 people in used by 39.9% of patients (NHLBI) Evidence-Based Management of the United States with SCD, most used 0–5 Sickle Cell Disease Expert Panel Report, have SCD (CDC, mg OME daily, but 3% of 2014—In adults and children with SCD and 2017). children and 23% of adults a vaso-occulsive crisis there is no specific used more than 30 mg OME guidance on opioid prescribing for outpatient SCD occurs among daily; vaso-occlusive crisis use in terms of dosage and duration. an estimated 1 and avascular necrosis were “Rapidly initiate treatment with parenteral out of every 365 associated with high-dose opioids in adults and children with a vaso- black or African- opioid use (Han et al., occlusive crisis associated with severe pain” American births 2018). (NHLBI, 2014; Yawn et al., 2014). and among approximately 1 SCAC (the Sickle Cell Advisory Committee) out of every 16,300 of GENES (The Genetic Network of New Hispanic-American York, Puerto Rico, and the Virgin Islands) births (CDC, Guidelines for the Treatment of People with 2017). Sickle Cell Disease—“Mild to moderate pain is usually controlled with acetaminophen or NSAIDs. If pain persists or escalates, opioids should be added” (SCAC/GENES, 2002). New England Pediatric Sickle Cell Consortium Management of Acute Pain in Pediatric Patients with Sickle Cell Disease (Vaso-Occlusive Episodes)—“Consider discharge home from ED if pain is captured with minimal number of doses (≤2) of IV opioids and then controlled with oral medication” (New England Pediatric Sickle Cell Consortium, 2009). continued

116 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Sprains and strains, A meta-analysis of Between 2014–2015, opioid American Physical Therapy Association musculoskeletal 144 studies found prescribing for opioid-naïve Ankle Stability and Movement Coordination the incidence of patients treated in EDs for Impairments: Ankle Ligament Sprains– ankle sprain is ankle sprains varied at the Clinical Practice Guidelines Linked to the higher in females state level from a low of International Classification of Functioning, compared with 2.8% in North Dakota to Disability and Health from the Orthopaedic males (13.6 40.0% in Arkansas; median Section of the American Physical Therapy versus 6.94 per was 21.3% (Delgado et al., Association—Does not mention opioids 1,000 exposures), 2018). (Martin et al., 2013). in children compared with Between 2008–2016, of Loveless and Fry Pharmacologic Therapies adolescents (2.85 454,813 opioid-naïve in Musculoskeletal Conditions—“For acute versus 1.94 per patients with an ankle pain, short-acting opioids are recommended” 1,000 exposures), sprain, 8.3% filled an opioid (Finney et al., 2019). and adolescents prescription within 7 days of compared with diagnosis and among those adults (1.94 who did so, 8.4% continued versus 0.72 per to use opioids more than 1,000 exposures) 90 days later (Finney et al., (Doherty et al., 2019). 2014). In 2016, approximately Based on the U.S. 26–33% of ED patients with National Electronic a sprain or strain received Injury Surveillance a discharge prescription for System of ED opioids (Schappert and Rui, visits between 2019). 2002–2006, there were an estimated 3.1 million ankle sprains occurred among an at-risk population of 1.5 billion person- years for an incidence rate of 2.15/1,000 person- years (Waterman et al., 2010). In 2016, 3.0% of ED visits (145.6 million) were for sprains and strains of the neck, back, ankle or other areas (Schappert and Rui, 2019).

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 117 TABLE 5-3 Continued Criteria for Developing Clinical Practice Guidelines Evidence of Variation in Selected Examples of Available Guidelines Prevalence of Prescribing or Over- or That Address Opioid Prescribing for Acute Indication Medical Indication Under-Prescribing Pain for the Specific Indication Tendonitis/bursitis In 2014, among Among 13,371 patients American Physical Therapy Association 176,607 patients with tendonitis/bursitis, 457 Achilles Pain, Stiffness, and Muscle Power visiting a primary patients (3.4%) filled an Deficits: Midportion Achilles Tendinopathy care setting for opioid prescription within Revision 2018—Clinical Practice Guidelines an episode of 7 days of initial visit, and Linked to the International Classification acute pain, 13,371 17.7% requested ≥1 refill of Functioning, Disability and Health from patients had (Mundkur et al., 2019). the Orthopaedic Section of the American tendonitis/bursitis Physical Therapy Association—No mention (Mundkur et al., of opioids (Martin et al., 2018b). 2019). Jones Nonsurgical Management of Knee Pain in Adults—Opioid analgesics should be used only if conservative pharmacotherapy is ineffective in patients who are not candidates for surgery (Jones et al., 2015). Javed Elbow Pain: A Guide to Assessment and Management in Primary Care—No mention of opioids (Javed et al., 2015). American College of Rheumatology Tendinitis and Bursitis Fact Sheet—No mention of opioids (Huston, 2019). NOTE: CI=confidence interval; CPG=clinical practice guideline; ED=emergency department; MME=morphine milligram equivalent; NHANES=National Health and Nutrition Examination Survey; OME=oral morphine equivalent; SCD=sickle cell disease. EMERGENCY DEPARTMENT CONSIDERATIONS While there exists enough evidence for many acutely painful conditions, such as acute low back pain, to generate condition-specific guidelines on the use of opioids, the committee also recognizes the importance of having clinical setting–specific guidelines for pain management in patients after they are discharged from the ED (Chou et al., 2017; Qaseem et al., 2017). Pain is one of the most common reasons patients present to the ED, representing the primary symptom in 45% of visits (Chang et al., 2014). And the ED is the most appropriate care setting for the management of severe pain episodes, with primary care offices and outpatient clinics often triaging patients to the ED for acute management. Therefore, prompt, safe, and effective pain management is a core mission of clinical practice in the ED. The NHAMCS for 2006–2010 indicated that opioids were prescribed for about 18.7% of all ED discharges (Kea et al., 2016). Kea et al. (2016) used NHAMCS data to assess ED discharge opioid pre- scribing practices for adults and children. During this period, there were 502.4 million ED discharges, in which opioids were prescribed for 94.0 million patients. Overall, opioid prescribing increased from 17.2 million discharges with opioids in 2006 to 20.2 million discharges with opioids in 2010. The rate of opioid prescriptions is 14.9% for ED visits and 2.8% for outpatient visits for adolescents and young adults (Hudgins et al., 2019).

118 FRAMING OPIOID PRESCRIBING GUIDELINES FOR ACUTE PAIN The specialty of emergency medicine was among the first to promote specialty-specific pain management guidelines regarding opioid prescribing (ACEP, 2017; Cantrill et al., 2012; Motov et al., 2017). Today there are numerous national, state, and municipal CPGs and policy statements on acute pain management in the ED that include the use of opioids upon discharge from the ED (ACEP, 2017; Broida et al., 2017; Cantrill et al., 2012; Motov et al., 2017; NYCDOH, 2019). When patients present to the ED with severe acute pain, ED clinicians carry out clinical assessments and diagnostic tests, seeking to identify the cause of the pain and to determine whether the patient should be admitted to the hospital or discharged. While in the ED, patients may receive treatment for acute pain and for the underlying cause of pain. Acute pain management in the ED is ideally patient-specific, pain syndrome–targeted, and based on appropriate pharmacologic and nonpharmacologic approaches (Motov et al., 2017). For example, some patients presenting with an acute shoulder dislocation may have their pain relieved with injection of lidocaine into the shoulder joint before relocating the shoulder, while others may require intravenous opioids to achieve adequate pain control prior to relocating the shoulder. As in any clinical setting, the goals of managing patients with acute pain who are being discharged from the ED are to alleviate pain, restore function, and reduce the potential for adverse effects of medication. A common tenet in ED opioid prescribing guidelines is that given the known harms of opioid analgesia, ED clinicians should take every opportunity to use nonopioid and nonpharmacologic options to treat acute pain, especially on discharge, and to use opioid analgesics only when the benefits outweigh the risks (Strayer et al., 2017). For example, it has been found that among opioid-naïve patients with Medicaid insurance in Washington State who were prescribed opioids upon discharge from the ED, 13.7% went onto high-risk opioid use within 1 year, as compared with 3.2% among those who were not prescribed opioids (Meisel et al., 2019). Given that this finding is consistent across several studies in ED patients (Barnett et al., 2017; Hoppe et al., 2015a; Jeffery et al., 2018), in addition to the harms associated with diversion and misuse, a common recommendation for ED clinicians and others who treat acute pain is to keep opioid-naïve patients opioid-naïve when possible (Motov et al., 2017; Nelson et al., 2015). The ability to assess a patient’s response to treatments administered for pain in the ED allows for more individualized pain treatment than is possible in other outpatient settings. Thus, the patient’s response to analgesic treatment in the ED can guide the choice of whether to prescribe opioids upon discharge as well as the dosage and duration. If opioids are determined to be necessary, the risks of opioids can be reduced by prescribing only immediate-release formulations at the lowest effective dose and for the shortest appropriate course (Strayer et al., 2017). The time over which the acute pain is expected to resolve can guide the choice and duration of pain treatments. For example, a patient who presents with a dislocated shoulder that was relocated after intravenous analgesia is unlikely to have persistent severe pain, whereas a patient treated for long bone fracture is likely to require analgesia after discharge. For the majority of patients treated for acute pain in the ED, the pain improves or resolves within 6 days (Chapman et al., 2012); however, individual pain trajectories can vary widely (Daoust et al., 2019). Unlike the emerging literature documenting the average number of opioid pills used and left over after surgical procedures, there is a paucity of similar evidence for patients discharged from the ED. One study in a Canadian academic center ED found the median number of opioid pills consumed upon discharge was 7, but this varied from 3 pills for renal stones to 11 pills for fractures (Daoust et al., 2018). The authors concluded that opioid prescriptions from the ED for acute pain should be no more than a 3-day supply, with a maximum of 30 pills per prescription for patients with severe fracture pain (Daoust et al., 2018). Finally, a key distinguishing aspect of emergency medicine practice is that ED clinicians do not have a longitudinal relationship with their patients. The standard of care in emergency medicine is to refer patients back to their primary care or outpatient longitudinal provider within 2–5 days for reassessment,

IDENTIFYING AND PRIORITIZING INDICATIONS FOR CLINICAL PRACTICE GUIDELINES 119 particularly if symptoms are not improving. Given that EDs serve as a safety net location of care for underserved patients without longitudinal care providers, discharge prescription dosing quantities need to account for the challenges that patients may face in obtaining adequate follow-up care. For patients who face barriers in obtaining timely outpatient follow-up, a recommendation of returning to the ED for reassessment if symptoms have not resolved or are worsening is prudent. CONCLUSIONS Thus, based on the information presented above, the committee finds that opioid prescribing for acute postoperative pain varies substantially by provider and hospital, including EDs. Furthermore, as shown in Tables 5-2 and 5-3, the committee finds that there is evidence that excessive opioids are prescribed for acute pain associated with both surgical procedures and some medical conditions. Consequently, the committee also finds that some opioid-naïve patients who receive opioids for acute postoperative pain and acute pain episode from medical conditions may develop new chronic opioid use. Taken together, this body of evidence regarding variation in prescribing, excessive prescribing, and new prolonged use highlights the need to develop rigorous, evidence-based CPGs to direct opioid prescribing for the priority indications identified in Tables 5-2 and 5-3 that are aligned with actual pa- tient use in order to minimize unwarranted variation and excess prescribing. Because different kinds of providers may be caring for patients during surgical and medical care and providing prescriptions, such as advanced practice providers, trainees, or surgeons, the opioid CPGs needs to meet the needs of these individual groups. REFERENCES AAOS (American Academy of Orthopaedic Surgeons). 2014a. Management of anterior cruciate ligament injuries: Evidence- based clinical practice guideline. https://www.aaos.org/research/guidelines/ACLGuidelineFINAL.pdf (accessed August 28, 2019). AAOS. 2014b. Management of hip fractures in the elderly: Evidence-based clinical practice guideline. https://www.aaos. org/uploadedFiles/PreProduction/Quality/Guidelines_and_Reviews/guidelines/hip-fractures-elderly-clinical-practice- guideline-4-24-19%20-2.pdf (accessed August 28, 2019). AAOS. 2015a. AAOS information statement: Opioid use, misuse, and abuse in orthopaedic practice https://www.aaos.org/ uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1045%20Opioid%20Use,%20Misuse,%20and%20 Abuse%20in%20Practice.pdf (accessed August 28, 2019). AAOS. 2015b. Surgical management of osteoarthritis of the knee: Evidence-based clinical practice guideline. http://content. guidelinecentral.com/guideline/get/pdf/2437 (accessed August 28, 2019). AAOS. 2019. Management of rotator cuff injuries: Evidence-based clinical practice guideline. https://www.aaos.org/ globalassets/quality-and-practice-resources/rotator-cuff/rotator-cuff-cpg-final-9-16-19.pdf (accessed August 27, 2019). AAPD (American Academy of Pediatric Dentistry). 2018. Policy on acute pediatric dental pain management. Pediatric Dentistry 40(6):101–103. Abdullah, F., and J. Harris. 2016. Pectus excavatum: More than a matter of aesthetics. Pediatric Annals 45(11):e403–e406. ACEP (American College of Emergency Physicians). 2017. Optimizing the treatment of acute pain in the emergency department. https://www.acep.org/globalassets/new-pdfs/policy-statements/optimizing-the-treatment-of-acute-pain-in-the-ed.pdf (accessed August 26, 2019). ACOG (American College of Obstetricians and Gynecologists). 2018a. ACOG committee opinion no. 742: Postpartum pain management. Obstetrics & Gynecology 132(1):e35–e43. ACOG. 2018b. ACOG committee opinion: Perioperative pathways: Enhanced recovery after surgery. https://www.acog.org/ Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Perioperative-Pathways- Enhanced-Recovery-After-Surgery (accessed August 28, 2019). ADA (American Dental Association). 2018. Substance use disorders. https://www.ada.org/en/advocacy/current-policies/ substance-use-disorders (accessed August 28, 2019).

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The opioid overdose epidemic combined with the need to reduce the burden of acute pain poses a public health challenge. To address how evidence-based clinical practice guidelines for prescribing opioids for acute pain might help meet this challenge, Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence develops a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommends indications for which new evidence-based guidelines should be developed, and recommends a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications.

The recommendations of this study will assist professional societies, health care organizations, and local, state, and national agencies to develop clinical practice guidelines for opioid prescribing for acute pain. Such a framework could inform the development of opioid prescribing guidelines and ensure systematic and standardized methods for evaluating evidence, translating knowledge, and formulating recommendations for practice.

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