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Editor’s Spotlight/Take 5: Has Prescription-limiting Legislation in Rhode Island Helped to Reduce Opioid Use After Total Joint Arthroplasty?

Manner, Paul A. MD, FRCSC

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Clinical Orthopaedics and Related Research: February 2020 - Volume 478 - Issue 2 - p 200-204
doi: 10.1097/CORR.0000000000001109

Few aspects of clinical care are as controversial as pain management. Orthopaedic surgeons represent 2.5% of physicians in the United States, yet we write 7.7% of opioid prescriptions [9] and have the highest median number of prescriptions [8]. However, there is considerable uncertainty among our specialty on how much opioid medication we should be giving to patients in the peri-operative period.

In the past two decades, we’ve heard from experts who told us that we were systematically undertreating chronic pain and should be prescribing opioids with substantially less concern [3]. We then heard from experts that long-acting opioids might not be as safe as advertised [16]. Most recently, we’ve heard that physician-prescribed opioids were the cause of an overdose epidemic [21]. And there is plenty of evidence that the experts were both completely correct and egregiously wrong in the treatment of patients affected by pain, in that patients with chronic pain suffer needlessly (true), but that the safety of aggressive management was assured (false). And these patients have been, to a large extent, ignored in the tumult over opioids.

This month, we talk with Daniel B. C. Reid MD, MPH, lead author of an important article in this month’s Clinical Orthopaedics and Related Research®: “Statewide Prescription-Limiting Legislation and Postoperative Opioid Utilization Following Total Joint Arthroplasty” [19]. Interestingly, it turns out that clinical judgment, patient education, and a personalized approach to care seem to perform just fine when it comes to managing surgical pain. Although Dr. Reid’s group focused on arthroplasty, their findings are of interest to surgeons of any stripe. Management of peri-operative pain represents an ongoing challenge, and guidance on use of potentially lethal medication to combat that pain is valuable.

The current controversy over opioids, covered in greater detail in a 2017 CORR® Editorial [11], began in the late 1990s, when the American Pain Society [2] brought attention to undertreatment of pain. And the data shows that prescriptions for opioids rose sharply, both in terms of numbers and dosage. Between 1991 and 2011, painkiller prescriptions in the United States tripled from 76 million to 219 million per year; as a consequence, deaths from opioid overdose rose as well. Age-adjusted opioid poisoning deaths quadrupled from 1999 to 2011 [7]. But by 2012, clinicians and the public were well aware of the issue. According to a recent study by Zhu and colleagues [24], the number of new opioid prescriptions dropped more than 50% from July 2012 to December 2017, and the number of prescribers dropped by 30%.

At the same, it became clear that prescription opioids were no longer the predominant cause of death by overdose, and that the vast majority of opioid users were relying on illicit drugs such as heroin and fentanyl [5, 6, 14, 22].

Nonetheless, state legislators followed former White House Chief of Staff Rahm Emanuel’s advice that a good crisis should not be allowed to go to waste [15]. Currently, 35 states have operational Prescription Drug Monitoring Programs, and 11 additional states and one U.S. territory have passed legislation authorizing the development of a Prescription Drug Monitoring Programs. It’s not clear whether these programs work, though—some have shown reductions in opioid prescribing [1, 4], while others show changes which are modest at best [13, 20, 23]. However, the majority of available studies look at opioid use from the viewpoint of epidemiology, and provide little guidance for the orthopaedic practitioner. Hence, the need to look at specific patient groups, and to concentrate on patients undergoing surgery.

Reid and his colleagues [19] have done just that with their study on patients undergoing total joint arthroplasty. The Rhode Island Uniform Controlled Substances Act was enacted in 2016, and went into effect the next year. The limitations on prescribing are substantial, and include daily dosing, total number of doses, and duration. Reid’s group compared opioid dosing in both opioid-naïve patients and those patients already using opioids, and looked whether prescribing patterns changed after implementation of state law. Opioid-naïve patients received less medication within the first 30 days compared to patients treated before implementation, but patients who were already on opioids prior to surgery continued to receive medication at unchanged levels. In short, an exaggerated political response to an iatrogenic crisis may actually have brought some measure of sanity to clinical care.

Join me now for a Take 5 Interview with Daniel B. C. Reid MD, MPH, first author of “Statewide Prescription-Limiting Legislation and Postoperative Opioid Utilization Following Total Joint Arthroplasty.”

Paul Manner MD, FRCSC:The Rhode Island Uniform Controlled Substances Act mandates a maximum of 30 morphine milligram equivalents per day for patients with acute pain who have not received opioids in the last 30 days. This works out to four 5 mg tablets of oxycodone per day. Unless Rhode Islanders are remarkably stoic, this seems like a low dose for a patient who’s just undergone major orthopaedic surgery. How do we balance overprescribing with the risk of undertreatment of pain?

Daniel B. C. Reid MD, MPH: While Rhode Island is certainly home to wonderful citizens, I do not believe they are any more stoic then citizens of other states. It appears more likely that the patients and physicians in Rhode Island and the rest of the United States have grown accustomed to opioid overprescription during the last 2 to 3 decades. A number of factors, including aggressive marketing of prescription opioids by the pharmaceutical industry, national initiatives like “pain as the fifth vital sign”, and increasing pressure on physicians and hospitals to improve chronic and postoperative pain, appeared to have contributed to the dramatic rise in opioid utilization during this time period [10]. Usage of high doses of postoperative opioid pain medications appears to be less associated with the specific procedure, but rather the location in which it is performed. Patients in the United States routinely receive far higher doses of opioid pain medications than patients in many other countries. A 2009 study comparing the United States to the Netherlands found that 77% of patients undergoing surgery for hip fractures and 82% of those undergoing surgery for ankle fractures in the United States used outpatient opioid pain medications following surgery [12]. This compared to 0% and 6% of Dutch patients, respectively, in that same study. In our institution, immediately prior to implementation of the aforementioned legislation, even previously opioid-naïve patients were routinely receiving triple the currently allowable opioid dose after leaving the hospital. As surgeons, we were certainly concerned about the possibility for severe undertreatment of pain given such a dramatic shift in practice mandated by the state. We were anxious that our patients would be miserable following surgery, our office staff would be bombarded with calls about poorly controlled pain, our emergency departments would be filled with patients seeking prescription refills, and our patient satisfaction scores would suffer accordingly. In fact, my personal experience, and the experience of many of my colleagues, has been far different than we initially expected. The vast majority of patients have been surprisingly understanding, and they seem to agree with the new model. While calls to the office and the usage of early post-operative refills have increased slightly, this burden has been far lower than anticipated. Furthermore, we have not found any major increase in emergency department visits, unplanned hospital readmissions, or reoperations for pain when evaluating the effect of this legislation on related subspecialties including spine surgery [17, 18]. Based on our experience, once patient populations become accustomed to more conservative opioid pain regimens, they can accommodate surprisingly well to even rapid paradigm shifts. Certainly, balancing the risks of opioid overprescription with those of potential undertreatment of pain is challenging and will require further experience and objective data. Strict legislative restraints on prescribers of opioids appear to be becoming more and more common across the country. This pattern is unlikely to abate. In our experience, maintaining close communication with patients, determining which patients are at high-risk for poor post-operative pain control prior to surgery, and having the technological tools available to correct for undertreatment of pain remotely, including electronic prescribing of controlled substances, are important factors for easing this transition.

Dr. Manner:It’s interesting that we see a reduction in use of opioids early and within the first 30 days, but not after the first 30 days. My clinical experience is that patients already exposed to opioids continue to need them long term; the opioid-naïve patients, by contrast, stop spontaneously. Was that the case here? And if so, is there a better way to manage the needs of these groups?

Dr. Reid: Many studies have suggested that patients who have been previously exposed to opioids are much more likely to continue to use such medications long-term. When evaluating our data, after controlling for gender, preoperative benzodiazepine exposure, presence or absence of the legislation in question, and specific surgical procedure, pre-operative opioid use was the factor most strongly associated with prolonged opioid use. The fact that the regulations were associated with reduced opioid utilization only within the first 30 days suggests that such legislation is a more-effective determinant of prescriber behavior then patient behavior. Those patients who are high-risk for using opioids over the longer-term following surgery remain high-risk regardless of targeted legislation. This problem can be a real challenge to manage. Early identification of patients at risk for long-term usage is important. Patients already using opioid pain medications should be encouraged to decrease consumption prior to surgery. Additionally, surgeons should take the time to develop long-term pain control plans in the preoperative period. Establishing clear boundaries, maintaining surveillance for dual prescribing, and encouraging access to naloxone for overdose reversal, all are ways to improve quality of care.

Dr. Manner:One of the concerns at the time of the introduction of bundled care was that surgeons would be less willing to operate on the “toughies”—those patients with multiple medical problems, or with less social support. Was there a change in clinician willingness to operate on opioid-tolerant patients after passage of the 2017 law? If so, what should we do about that?

Dr. Reid: Providing care for patients with multiple or complex problems takes considerable time and energy. Not only are patients who present already habituated to opioid medications potentially more work for physicians and their staff who may already be overburdened, but the inherent risk of managing such patients may affect surgeon willingness to provide necessary care. The implementation of strict guidelines and close monitoring of prescription patterns by the state may further disincentivize the care of such patients. Counterintuitively, our experience has been that such regulations may strengthen the doctor-patient relationship. Our patients understand and appreciate the need for systemic solutions to the current opioid crisis. When appropriate preoperative expectations are set and pain-management plans are followed, most patients do surprisingly well with very small opioid doses. Even in difficult social situations, most physicians in our practice appreciate that they are no longer forced to be the “bad guy,” allowing the state to take on that role. Objectively, we did not see a substantial reduction in the proportion of patients previously habituated to narcotics who were treated with total joint arthroplasty following implementation of the law. While this suggests that cherry-picking of patients who were naïve to opioids prior to surgery in the post-legislation climate does not appear to be a major problem, further surveillance is certainly indicated.

Dr. Manner:The legislation in question took effect in 2017. But there are good data to show that prescription of opioids was on a downward trend well before 2017, both in Rhode Island and across the country. If that is so, was this legislation effective? What’s the best approach for policy makers to provide timely and useful guidance?

Dr. Reid: This is an important point. The legislation in question was passed in the midst of a growing recognition of the negative effects of opioids on patients, populations, and society as a whole. There is evidence that national opioid prescription rates peaked around 2010 to 2012 and have been slowly decreasing since then. It is certainly possible that national trends may have contributed in part to our findings. Nonetheless, it is unlikely that the magnitude of early prescription changes seen in the relatively short period between passage and implementation of the legislation can be explained by national trends or confounding variables alone. Personally, this legislation has affected my daily practice as well as that of my colleagues. We prescribe far less opioid medication than we did even a few years ago, and have achieved a much greater reduction than many of us initially thought possible. For small procedures, opioids are rarely prescribed. With appropriate preoperative discussion and setting of expectations, many patients do not even fill their opioid prescriptions after surgery.

Regulations like those in place in Rhode Island are being enacted elsewhere; at least 36 states now have similar laws. There is an inherent conflict between the importance of using objective evidence to guide policymaking and the need for policymakers to address this important and wide-ranging crisis expeditiously. Early evidence as presented here appears to support the efficacy of such legislation in reducing early postoperative opioid utilization. Further rigorous study, including cross-state comparisons, monitoring of long-term effects, and surveillance for unintended consequences, is urgently needed.

Dr. Manner:Presumably, one reason (if not the main one) to restrict opioid prescriptions is to reduce the chance of dying from an overdose. But what we see in Rhode Island is that the number of deaths by overdose is 232 in 2013, 240 in 2014, 290 in 2015, 336 in 2016, 324 in 2017, and 314 in 2018. It’s too early to tell what happens this year, but these figures indicate that the legislation has had little influence one way or the other. Is the legitimate prescription of opioids really the problem?

Dr. Reid: While preventing overdose is certainly an important goal of prescribing restrictions, it is not the only goal. Even “safe” use of opioids has been associated with inferior patient outcomes, poorer patient satisfaction scores, chronic pain, and social/family problems. Furthermore, despite being associated with only a small proportion of opioid-related overdose deaths, prescription medications continue to be a primary source of opioids used for non-medical use through diversion. Over-prescription, in combination with poor patient education on proper disposal methods, likely contribute to this phenomenon. There does appear to be a slight trend toward decreasing overdose deaths in Rhode Island since 2016. This is especially interesting given the simultaneous increase in accidental overdose deaths nationally during this same period. Regardless, such comparisons are fraught with confounding, especially given the recent rise in overdose deaths secondary to synthetic opioids, such as fentanyl. Clearly, further surveillance and cross-state comparisons are needed.

Daniel B. C. Reid MD, MPH

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