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theory"},{"term":"tappana"},{"term":"tarbi"},{"term":"taylor"},{"term":"tea"},{"term":"telehealth"},{"term":"theatre"},{"term":"thienprayoon"},{"term":"thurston"},{"term":"time"},{"term":"tinianov"},{"term":"toomey"},{"term":"transdisciplinary"},{"term":"transgender"},{"term":"transition"},{"term":"trapasso"},{"term":"trauma"},{"term":"triangulation"},{"term":"tribute"},{"term":"trust"},{"term":"twiter"},{"term":"uncertainty"},{"term":"unconscious"},{"term":"universe"},{"term":"upstairs"},{"term":"urology"},{"term":"van Meines"},{"term":"van mienes"},{"term":"vandekieft"},{"term":"veteran"},{"term":"video"},{"term":"volunteering"},{"term":"warraich"},{"term":"washington"},{"term":"weakness"},{"term":"webinar"},{"term":"whitburn"},{"term":"wollesen"},{"term":"young"},{"term":"young adult"},{"term":"zitter"}],"title":{"type":"text","$t":"Pallimed"},"subtitle":{"type":"html","$t":"Pallimed covers current palliative medicine, hospice, and end-of-life research and news, with a particular focus on publications not from the major palliative care journals.  It is aimed at health care professionals who work with people nearing the end of life."},"link":[{"rel":"http://schemas.google.com/g/2005#feed","type":"application/atom+xml","href":"https:\/\/www.pallimed.org\/feeds\/posts\/default"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/-\/pain?alt=json-in-script\u0026max-results=6"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/search\/label\/pain"},{"rel":"hub","href":"http://pubsubhubbub.appspot.com/"},{"rel":"next","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/-\/pain\/-\/pain?alt=json-in-script\u0026start-index=7\u0026max-results=6"}],"author":[{"name":{"$t":"Drew Rosielle MD"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/04345646798042773615"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"32","height":"32","src":"\/\/3.bp.blogspot.com\/-sdxTTBPb3Kw\/UddApiGn9-I\/AAAAAAAABLE\/mriu5xh44dA\/s113\/ea37b7645cd78e7867d246cd755bc8d4.jpeg"}}],"generator":{"version":"7.00","uri":"http://www.blogger.com","$t":"Blogger"},"openSearch$totalResults":{"$t":"180"},"openSearch$startIndex":{"$t":"1"},"openSearch$itemsPerPage":{"$t":"6"},"entry":[{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-6789906096915190345"},"published":{"$t":"2021-05-03T16:55:00.004-05:00"},"updated":{"$t":"2021-05-06T16:34:10.222-05:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"CDC"},{"scheme":"http://www.blogger.com/atom/ns#","term":"health policy"},{"scheme":"http://www.blogger.com/atom/ns#","term":"kollas"},{"scheme":"http://www.blogger.com/atom/ns#","term":"opioids"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"policy"},{"scheme":"http://www.blogger.com/atom/ns#","term":"prop"}],"title":{"type":"text","$t":"PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences"},"content":{"type":"html","$t":"\u003Cp style=\"margin-left: 40px\"\u003E\u003Ci\u003E\u003C\/i\u003E\u003Cbr\u003E\u003C\/p\u003E\u003Cdiv class=\"separator\" style=\"clear: both;\"\u003E\u003Ca href=\"https:\/\/1.bp.blogspot.com\/-QSZPR6GtcdM\/YJBwbOpJ-eI\/AAAAAAAAAao\/Fp6pV5FzlWsOJHgmhHvFH-d0mvVKo_uvwCLcBGAsYHQ\/s1080\/OUD%2BPost%2B%25286%2529.png\" style=\"display: block; padding: 1em 0; text-align: center; clear: right; float: right;\"\u003E\u003Cimg alt=\"\" border=\"0\" width=\"320\" data-original-height=\"1080\" data-original-width=\"1080\" src=\"https:\/\/1.bp.blogspot.com\/-QSZPR6GtcdM\/YJBwbOpJ-eI\/AAAAAAAAAao\/Fp6pV5FzlWsOJHgmhHvFH-d0mvVKo_uvwCLcBGAsYHQ\/s320\/OUD%2BPost%2B%25286%2529.png\"\/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Chad Kollas, MD (\u003Ca href=\"https:\/\/twitter.com\/ChadDKollas\" target=\"_blank\"\u003E@ChadDKollas\u003C\/a\u003E) \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EIntroduction\u003Cbr\u003E\u003Cbr\u003E\u003C\/b\u003EA recent study by the Centers for Disease Control (CDC) has captured the attention of the palliative care and chronic pain communities (1). Published on February 12, 2021, in Morbidity and Mortality Weekly Report (MMWR), it observed that the “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019” have increased a whopping 1,040% (1). Several critics have attributed this increase in overdose mortality to failed federal opioid policy, particularly the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain and their misapplication (2-4). This criticism has generated recent flurry of activity on social media by the anti-opioid advocacy group (5), Physicians for Responsible Opioid Prescribing (PROP). This commentary will explore how PROP’s flawed policy approach over the last decade has reduced legitimate access to opioid medications and contributed to harms from increases in overdose deaths in the United States (US). \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EPROP Appears on the Opioid Policy Scene\u003Cbr\u003E\u003Cbr\u003E\u003C\/b\u003EIn 2011, a group of internists, including Michael Van Korff, Andrew Kolodny and Roger Chou, co-authored an article that modern palliative care physicians would recognize as a “warning shot (6)” in the world of opioid policy (7).  They announced the creation of Physicians for Responsible Opioid Prescribing (PROP), a “nonprofit organization with no pharmaceutical industry funding or ties,” that would “identify practical approaches to more cautious opioid prescribing in community practice (7).” They declared that “Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety (7).”  \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EPROP Petition to the FDA on Opioid Labeling\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EThe Petition is Filed\u003C\/i\u003E\u003Cbr\u003E\u003C\/center\u003EIn its first effort to influence national opioid policy, in July 2012, PROP submitted a Petition to the Food and Drug Administration (FDA) calling for a change in labeling of opioid analgesics (8). Signatories to the Petition included PROP President, Andrew Kolodny, PROP Vice-president, Michael Van Korff, and PROP Board Members, Jane Ballantyne, Roger Chou, Stephen Gelfand, and Gary Franklin, among other medical specialists, including American Society of Addiction Medicine (ASAM) President, Stu Gitlow (8). In its petition, PROP requested that the FDA to make three main changes to the labeling process for opioid analgesics:\u003Cbr\u003E\u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;1)\tStrike the term “moderate” from the indication for non-cancer pain (the only clinical indication for using an opioid analgesic would be for severe cancer pain).\u003Cbr\u003E  \u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;2)\tAdd a maximum daily dose of opioid analgesia, equivalent to 100 milligrams of oral morphine, for treatment of all non-cancer pain. \u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;3)\tAdd a maximum duration of 90-days for continuous (daily) opioid analgesia use for non-cancer pain, after which opioid analgesia would be discontinued (8).\u003Cbr\u003E  \u003Cbr\u003EThe FDA acknowledged receipt of the PROP Petition on July 26, 2012 (9), and it simultaneously received a letter of support for its petition on the same date, led by Congress member, Representative Mary Bono Mack from California (10).  \u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EThe Backlash to the PROP Petition Begins\u003Cbr\u003E\u003C\/i\u003E\u003C\/center\u003EThis unity within the supporters of the petitioning group was short-lived. A representative from within the palliative care community alerted PROP FDA Petition signatory and American Society for Addiction Medicine (ASAM) President, Stu Gitlow, about substantial concerns from the pain management and palliative medicine communities about the potential reduced access to opioid therapy for many patients. In response to concerns that the PROP Petition might have a chilling effect on medically-legitimate opioid prescribing, ASAM released a statement by Gitlow clarifying its position that “the relabeling proposals [were] not intended, in any way, to limit a chronic pain patient’s access to clinically appropriate opioid pain therapy or to impinge upon a pain specialist’s ability to make individual decisions regarding the most effective therapy for their legitimate pain patient (11).”\u003Cbr\u003E\u003Cbr\u003E  Several prominent pain management experts echoed important concerns about over-restricting patients’ medically legitimate access to opioid analgesics. Bob Twillman, a pain psychologist and Director of Policy and Advocacy for the American Academy of Pain Management (AAPM), pointed out that “the 90-day limit on use of opioid for [non-cancer pain was] arbitrarily chosen (12).” Because PROP’s Petition had criticized the use of long-term opioid therapy by citing a lack of evidence for opioids’ long-term effectiveness, Twillman also pointed out that “when considering opioid analgesics, FDA has used the standard of a 12-week trial of the medication[;] it has not required longer studies (12).” Similarly, co-chair the New York State Palliative Care Education and Training Council and palliative medicine physician, Russell Portenoy, wrote that in light of “the stunning disconnect between the label changes demanded in the petition and the ‘scientific basis’ presented to justify them, I am concerned that all of the signatories possess an incomplete understanding of opioid pharmacology and pain medicine, and as a result, may pursue regulatory changes that are not in the best interest of public health (13).” \u003Cbr\u003E\u003Cbr\u003EOther PROP critics included several medical professional organizations, like the American Society of Anesthesiologists (ASA), who challenged the clarity of a definition of cancer pain, asking rhetorically, “Who will decide whether the persistent pain, for example, of nerve damage incurred during an otherwise curative course of chemo- and radiation therapy is or is not cancer-related? (14).” Likewise, the American Academy of Pain Medicine (AAPM) stated “we have serious concerns about the petition and believe the rationale for the requested changes is seriously flawed, potentially harmful to patients with debilitating pain conditions for whom opioid therapy is indicated, and without substantive scientific foundation (15).” \u003Cbr\u003E\u003Cbr\u003EThe American Pain Society (APS) cited similar concerns about the Petition’s “insufficient scientific evidence base to support [its] recommendations. Further, we are concerned that implementation of these labeling changes which would dictate indications, dosing and duration of opioid treatment will not accomplish the intended goals, but instead have unintended negative consequences for patients including but not limited to untreated pain and loss of access to individualized care (16).” \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EFDA Response to the PROP Petition\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EOn September 10, 2013, the FDA provided its response to the PROP Petition to change opioid labeling, which was granted in part and denied in part (17, 18). The FDA agreed with PROP that “more data are needed about the safety of long-term use of opioids,” and, to this end, they required “all new drug application (NDA) sponsors of ER\/LA opioids to conduct postapproval studies and clinical trials… to assess certain known serious risks of ER\/LA opioid use: misuse, abuse, hyperalgesia, addiction overdose and death (17).” Additionally, based on stakeholder input, the FDA determined that “safety labeling changes to the labeling of ER\/LA opioid analgesics [were] needed to more effectively communicate to prescribers the serious risks associated with [those] drugs, and to more clearly describe the population in whom these drugs should be used be used in light of these serious risks – thus encouraging better prescribing, monitoring and patient counseling practices involving these drugs (17).” This included a new box warning to disclose risks from ER\/LA opioid analgesics and the addition of the phrase, “indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (17).” \u003Cbr\u003E\u003Cbr\u003EDespite calling for these changes, the FDA disagreed with the most important requests from the PROP Petition. It rejected PROP’s separation of non-cancer pain from cancer pain, noting “a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients (17).” The FDA also rejected PROP’s call for a 100 mg\/day maximum morphine equivalent (MME) daily dose limitation, noting “the scientific literature does not support establishing a maximum recommended dose of 100 mg MED (17).” Furthermore, the FDA noted that creating a maximum dose of 100 mg MED “could imply a superior opioid safety profile under that set threshold, when there is no data to support that conclusion (17).” Finally, the FDA determined that PROP’s request to limit the maximum duration of treatment with opioid analgesia to 90 days was “not supportable” based on the evidence presented in the Petition (17). \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EPROP’s Influences the CDC Guidelines\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003E\u003Ccenter\u003EA New Federal Regulatory Target\u003C\/center\u003E\u003C\/i\u003E\u003Cbr\u003EAlthough the FDA had rejected the most important changes which PROP had requested, based on a lack of scientific evidence, PROP publicly framed its FDA Opioid Labeling Petition as successful, then repeated its calls for a 100 mg\/day MME (19). PROP had also explored other avenues to influence opioid policy and reduce opioid prescribing, reaching out for example to the Federation of State Medical Board (FSMB) to encourage it to make changes in its Revised Model Policy on the Appropriate Use of Opioid Analgesics in the Treatment of Pain (20). Ultimately, PROP identified a more accommodating regulatory agency than the FDA, the Centers for Disease Control and Prevention (CDC), which revealed via engagement webinars on September 16 and 17, 2015, that it had been drafting its own Opioid Prescribing Guidelines (21). \u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003E\u003Ccenter\u003EAnother PROP Backlash\u003C\/center\u003E\u003C\/i\u003E\u003Cbr\u003EIn the days following these engagement webinars, critics expressed concerns about a lack of transparency in the drafting of the Opioid Prescribing Guidelines, because CDC had failed “to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians (22).” Additional concerns involved an unusually short, 48-hour period for stakeholders to submit comments about the CDC Pain Guidelines upon their originally planned release in September 2015 (23). Moreover, revelations that at least five PROP Board Members - including PROP President Jane Ballantyne, PROP Vice-President Gary Franklin, PROP Founder Andrew Kolodny, PROP Board Member David Tauben and PROP Board Member David Juurlink – had served on the panels that helped develop the CDC Guidelines, stirred deeper concerns (23, 24).  Jane Ballantyne MD, who had succeeded Andrew Kolodny as PROP President, served as the sole clinician from the pain management community to be included in the CDC Core Expert Group (25). \u003Cbr\u003E\u003Cbr\u003EMedical professional organizations joined in criticism of the CDC for a lack of transparency in its policy review process and the scarcity of pain management experts represented in the Core Expert Group (26). The American Medical Association (AMA) wrote that the “review process used to date by CDC, especially the public engagement webinars, [had] generated concern about lack of transparency (26),” and that the “process may have been better served by constructing a more balanced panel that included clinicians from various medical specialty and practice settings (26).” The Patient Quality of Life Coalition (PQLC), an advocacy group that included the American Academy of Hospice and Palliative Medicine (AAHPM), AAPM, the Center to Advance Palliative Care (CAPC), and the Hospice \u0026 Palliative Nurses association (HPNA), among others, wrote that “the Guideline in its current form is focused on curbing inappropriate [opioid] use, but seems devoid of empathy for patients who need legally‐prescribed opioid medications for relief from serious and long‐lasting pain that compromises their quality of life and independence (27).” \u003Cbr\u003E\u003Cbr\u003EFollowing this outcry for transparency and expanded clinical representation regarding content, the CDC announced a second, 30-day open-comment period on its proposed 2016 Pain Guidelines, effective December 14, 2015 (28, 29). This delayed the roll out of the CDC Pain Guidelines past its originally anticipated implementation in January 2016, and prompted PROP founder, Andrew Kolodny to complain, “Opening a docket will tack months on to the process [and also] increases the likelihood that the guideline may never be released. This is an enormous win for the opioid lobby (30).\" Interestingly, Kolodny co-authored a subsequent article examining the role of pharma funding and support of the CDC Pain Guidelines, and found that “of the 158 organizations that commented on the CDC’s draft guidelines, approximately 80% supported them either with or without recommendations, including many that received funding from opioid manufacturers (31).” \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EThe CDC Guidelines are Published, Despite Ongoing Concerns\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003ENotwithstanding PROP-founder Kolodny’s fears that the guidelines “may never be released (30),” the CDC Pain Guidelines were published via MMWR on March 18, 2016 (4). While most pain experts generally felt that the Pain Guidelines would be useful for those prescribing opioids in primary care settings, many expressed concerns that the Guidelines could be misapplied and affect a much broader group of patients than intended. For example, AMA board chair-elect, Patrice Harris, said that while the AMA shared the goal of reducing harm from opioid abuse, it remained concerned “about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences” including insurance coverage limitations for non-pharmacotherapeutic options for chronic pain (30). Similarly, Bob Twillman, executive director of the AAPM, said the CDC guidance “leaves much to be desired,” particularly regarding the limitations on dose, duration of treatment and arbitrary dosing threshold (32, 32). “Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these ‘soft limits’ and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result,” Twillman said (32). \u003Cbr\u003E\u003Cbr\u003EOn August 29, 2016, \u003Ci\u003Ea group of scientists from the CDC itself\u003C\/i\u003E expressed integrity concerns about the agency’s data and its “the current state of ethics,” noting that “[i]t appears that our mission is being influenced and shaped by outside parties and rogue interests (34),” without specifically identifying PROP as one of those forces. Calling themselves the “CDC Spider Group (CDC Scientists Preserving Integrity, Diligence and Ethics in Research),” they reached out to Carmen S. Villar, MSW Chief of Staff, Office of the Director for the CDC, plainly stating that CDC “data were clearly manipulated in irregular ways” for political purposes (34). In October 2016, an article echoed similar concerns regarding CDC’s manipulation of data in a variety of projects, again alleging that the CDC was being influenced by corporate and political interests in a way that compromised its data collection (34). Despite these warnings, the 2016 CDC Opioid Prescribing Guidelines were implemented as planned. \u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EUnintended Harms and the Backlash Against Misapplication of the CDC Guidelines\u003C\/i\u003E\u003C\/center\u003E\u003Cbr\u003E\u003Cbr\u003EJust two years later, yet \u003Ci\u003Eanother article\u003C\/i\u003E authored by CDC scientists was published in April 2018, again calling into question the methodology used by CDC to estimate opioid overdose deaths (35). The authors alleged that the CDC traditional method for calculating opioid overdose deaths \u003Ci\u003Eoverestimated deaths due to prescription opioids\u003C\/i\u003E because the CDC failed to account for the emergence of illegally-manufactured fentanyl (IMF) as a cause of overdoses in its methodology (35). The authors proposed a method that would exclude IMF-related deaths for a more accurate estimate of total opioid overdose deaths (35). Using its traditional method, the CDC “estimated 32,445 prescription opioid–involved deaths occur[ing] in 2016.” Using these authors’ proposed “more conservative method, 17,087 prescription opioid–involved deaths occurred in 2016.” The concerned scientists concluded that “obtaining an accurate count of the true burden and differentiating between prescription and illicit opioid-involved deaths [was] essential to implement and evaluate public health and public safety efforts (35).” \u003Cbr\u003E\u003Cbr\u003EIn addition to concerns about the accuracy of CDC’s overdose data, by 2018 it had become clear that misapplication of its Pain Guidelines had begun to contribute to deaths from “suicides within and outside of the Veterans Affairs Healthcare System in the United States” from forced or involuntary tapers off of opioid analgesics (36). Although the CDC had designed the Guidelines “as non-mandatory guidance for primary care physicians[,] legislators, pharmacy chains, insurers, and others [had] seized on certain parts of its dosage and supply recommendations and translated them into blanket limits in law[s] and mandatory policy (37).” These misapplications and unintended consequences prompted the passage of an AMA Resolution against ongoing, widespread misapplication of the CDC Pain Guidelines in November 2018 (38). Adopted by the AMA House of Delegates at its November 2018 Interim Meeting, the new AMA policy affirmed that: \u003Cbr\u003E\u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;1) \t“Some patients with acute or chronic pain [may] benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate,” \u003Cbr\u003E\u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;2) \tThe “AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia,” and, \u003Cbr\u003E\u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;3) \t“No entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guideline for Prescribing Opioids (38).”\u003Cbr\u003E\u003Cbr\u003EIn the months after adoption of this AMA policy change, more clinical professionals and medical societies would actively seek to reverse the harms of the CDC Pain Guidelines’ misapplication.  \u003Cbr\u003E\u003Cbr\u003EIn December 2018, a group of clinical leaders and international stakeholders in the pain management community signed an open letter calling for urgent action against forced tapering of opioids (36). On February 13, 2019, the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) sent a joint letter to Debra Dowell, Chef Medical Officer of the CDC Opioid Response Coordinating Unit, to follow up on a stakeholder meeting that  was held on November 8, 2018, during which those professional organizations called for CDC “to address unintended implementation and reimbursement consequences that have been occurring in practice” because of the misapplication of CDC’s Pain Guidelines (39). On February 19, 2019, Dowell answered back in a letter that stated, “The Guideline is not intended to deny any patients who suffer from chronic pain from opioid therapy as an option for pain management (40).” She also wrote, “CDC encourages physicians to continue to use their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment (40).” This response letter was embargoed for release until April 9, 2019 (40), to coincide with other anticipated press releases related to federal actions regarding misapplication of the Pain Guidelines (see below). \u003Cbr\u003E\u003Cbr\u003ESimilarly, on March 6, 2019, a group identified as Health Professionals for Patients in Pain (HP3) called upon “the CDC to follow through with its commitment to evaluate the impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation (41).” HP3 also urged “the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation (41).” The CDC responded on April 10, 2019, noting that “the Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm (42).” \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EFDA Warning and CDC Clarification About the Pain Guidelines\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EFDA Warning Against Rapid Tapers\u003C\/i\u003E\u003C\/center\u003E\u003Cbr\u003E\tOne day prior to the CDC response letter to HP3 (42), on April 9, 2019, the FDA posted a safety announcement warning against sudden discontinuation of opioid pain medications (43). In the announcement, the FDA noted that it had “received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide (43).” This information was also released via a special FDA podcast on 4\/17\/2019 (44). \u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003E\u003Ccenter\u003ECDC Warns Against Misapplication of its Pain Guidelines; PROP Gets Defensive\u003C\/center\u003E\u003C\/i\u003E\u003Cbr\u003E\u003Cbr\u003EIn view of the embargo for release of the CDC response to the NCCN-ASCO-ASH, which occurred on April 9, 2019 (40), and the CDC response to HP3 (42) on April 10, 2019, it seems likely that the FDA and CDC coordinated their communications to response to the Pain Guideline backlash. CDC then released another embargoed statement on April 24, 2019, in which it advised against the misapplication of its Guideline for Prescribing Opioids for Chronic Pain (45). More explicitly, CDC sought to raise “awareness about the following issues that could put patients at risk: \u003Cbr\u003E\u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; - Misapplication of recommendations to populations outside of the Guideline’s scope.  \u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; - Misapplication of the Guideline’s dosage recommendation that results in hard limits or ‘cutting off’ opioids. \u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; - The Guideline does not support abrupt tapering or sudden discontinuation of opioids. \u003Cbr\u003E\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; - Misapplication of the Guideline’s dosage recommendation to patients receiving or starting medication-assisted treatment for opioid use disorder (45).”\u003Cbr\u003E\u003Cbr\u003EOn the heels of this media release, the CDC referenced a companion article published in New England Journal of Medicine (NEJM), co-authored by PROP member and CDC Core Group member, Roger Chou, which was available online on April 24, 2019, and in print on June 13, 2019 (46). Those authors also admitted that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations (46).” But in contrast to the contrite note struck by the CDC media release, the NEJM article vigorously defended the Pain Guidelines, noting that “the medical and health policy communities [had] largely embraced its recommendations” and that “the guideline was rated as high quality by the ECRI Guidelines Trust Scorecard (46).” The NEJM article also dismissed allegations about the lack of transparency in the Guideline creation, noting that the CDC had “engaged clinicians, health systems leaders, payers, and other decision makers in discussions of the guideline’s intent and provided clinical tools, including a mobile application and training, to facilitate appropriate implementation (46).” Notably, the article ended with this disclaimer: “The views expressed in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (46).”  \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EUndeclared Conflicts of Interest\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\tLess than a month after the printed publication of the Chou’s NEJM article defending the Pain Guidelines, the US Department of Justice (DOJ) announced obtaining a record-setting $1.4 billion settlement against Reckitt Benckiser, the manufacturer of Suboxone, an opioid addiction treatment drug (47). For years, critics had alleged financial connections between PROP members and Reckitt Benckiser, with suspicions driven by comments by PROP’s Kolodny, who in 2005 - when asked about his financial relationship with the company - replied, “They are not a pharmaceutical company. They make Lysol (48).\" In 2015, Reckitt Benckiser had spun off its Suboxone manufacturing to a subsidiary that it named Indivior (49), more commonly identified as its manufacturer currently. Additionally, in recorded testimony during government hearings, Kolodny had encouraged the use of Suboxone as a measure to combat the opioid crisis. In 2011, at a New York State Senate Hearing, then-PROP President Kolodny testified, ““If we want to see a decline in overdose deaths, you have to [sic] provide effective treatment for people who are opioid-addicted. And for this epidemic, that’s probably going to mean buprenorphine (50).” Likewise, during a US Senate Hearing in 2018, Kolodny testified, “The first-line treatment for opioid addiction is buprenorphine, also called ‘’Suboxone.’ Access to this treatment is not sufficient (51).” \u003Cbr\u003E\u003Cbr\u003ETestimony from hearings encouraging the use of Suboxone and deflective comments, like Kolodny’s dismissal about his relationship with Reckitt Benckiser, were less suspicious as betraying conflicting interests before it was revealed that PROP members failed to disclose relevant conflicts of interest when authoring several articles printed in medical journals. Kolodny failed to disclose conflicts of interest pursuant to his executive directorship of PROP and provision of expert witness testimony in malpractice cases involving opioids when he published two articles in the Journal of the American Medical Association (JAMA) in October 2017 and April 2018 (52). Similarly, PROP President, Jane Ballantyne, failed to disclose her affiliation with PROP in an “Ideas and Opinions” article, co-authored with PROP members, Anna Lembke and Roger Chau, in Annals of Internal Medicine in 2019 (53, 54). Moreover, PROP’s Mark Sullivan failed to declare a conflict of interest regarding his work on a opioid tapering device, which occurred during his participation in the drafting of the CDC Pain Guidelines, until he was participating in a CDC-sponsored Clinical Outreach and Community Activity, after the Guidelines’ publication (55). More recently, the British Medical Journal (BMJ) updated a “Rapid Response” that accused the AMA of a pharmaceutical industry bias when creating opioid policy, written by several members of PROP, when it was revealed that one of the co-authors, PROP’s Sullivan, did not disclose his competing interest related to his work as an expert witness in cases in Maryland and Missouri (56). \u003Cbr\u003E\u003Cbr\u003EDespite their collective tendency to under-report relevant conflicts of interest in publications, PROP members continued to place themselves successfully in key positions to enhance their ability to shape opioid policy. In early April 2020, the Agency for Healthcare Research and Quality (AHRQ) disclosed for the first time the identity of the authors of the controversial report, “Opioid Treatment for Chronic Pain,” which had concluded “opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose, especially at high doses (57).” The lead author of that report was revealed to be Roger Chou, a PROP member who has been described as “a vocal critic of opioid prescribing for years (58).” This revelation was especially concerning at the time, because CDC had announced its plans to review and possibly revise the 2016 CDC Pain Guidelines, which were co-authored by Chou, and because the AHRQ study had reaffirmed many of CDC’s still-disputed conclusions about opioid therapy (58).  \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003ECDC Begins a Reassessment of the 2016 CDC Pain Guidelines\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EOpen Docket for Comments\u003C\/i\u003E\u003C\/center\u003E\u003Cbr\u003EOn April 17, 2020, the CDC announced “the opening of a docket to obtain comment concerning perspectives on and experiences with pain and pain management, including but not limited to the benefits and harms of opioid use, from patients with acute or chronic pain, patients' family members and\/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management (59).” Eventually, it received 5,392 comments from patients, physicians, medical organizations, and other stakeholders with feedback about its 2016 Pain Guidelines (60). \u003Cbr\u003E\u003Cbr\u003EThe AAHPM did not mince words when commenting about its concerns of misapplication of the CDC Pain Guidelines: “The 2016 Guideline has been broadly misapplied, with devasting effect on patients and prescribers. Forced tapering of patients’ opioid prescriptions has been incentivized and\/or mandated, violating ethical and evidentiary norms of medical practice. This has resulted in many patients’ medical deterioration, loss of care relationships, turning to illicit substances\/alcohol, and suicidality. Swapping products and formulations to reduce opioid prescriptions where not medically necessary has also led to medical errors. At the same time, prescribers have faced professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram equivalent (MME) thresholds included in the CDC Guideline (61).” \u003Cbr\u003E\u003Cbr\u003EThe AMA echoed these concerns, writing “It is clear that the CDC Guideline has harmed many patients—so much so that in 2019, the CDC authors and HHS issued long-overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold (Italics mine, 62). It also noted that “the CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs,” and that “these policies, moreover, have not withstood any meaningful evaluation or data analysis as to whether they have improved pain care or reduced opioid-related harms (62). There also are no data to suggest that payers have increased access to non-opioid pain care options. If one of the goals of the CDC Guideline was to increase access to non-opioid pain care, that has not been realized (62). Rather, there is evidence that payers continue to erect and support barriers to non-opioid pain care (62).” The AMA urged the CDC to rescind policies employed by “many health insurers, pharmacy chains, and PBMs” based on the concept of a hard MME threshold to avoid “harms done to patients as a result of inappropriate tapering or denials of care (62, 63). \u003Cbr\u003E\u003Cbr\u003EIn its comments, PROP conceded that reduced opioid prescribing was associated with downward trends in “prescription opioid related morbidity and mortality (64),” but did not acknowledge a concomitant, upward trend in total opioid-related morbidity and mortality from illicit drug, including illegally manufactured fentanyl. They further argued, “For some patients, continued opioid use is necessary not because it effectively manages the pain that prompted opioid prescribing initially, but because continued use averts the negative effects of opioid discontinuation (64),” a claim advocates for patients with chronic pain have labeled as a gaslighting strategy (65). Furthermore, as discussed later in the article, PROP also incorrectly predicted, “The downward trends in new starts of chronic opioid treatment achieved by the 2016 guideline should be seen as a positive development that will encourage people to find alternative means of controlling chronic pain, which though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (65).” \u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EThe BSC\/NCIPC Workgroup\u003C\/i\u003E\u003C\/center\u003E\u003Cbr\u003EOn July 6, 2020, the CDC announced the formation of a new Opioid Workgroup and the Board of Scientific Counselors, National Center for Injury Prevention and Control Centers for Disease Control and Prevention (The BSC\/NCIPC Workgroup), which would “review the Opioid Workgroup’s report, discuss, deliberate, and provide advice and recommendations for CDC to consider as part of the potential update and\/or expansion of the Guideline. The updated and\/or expanded Guideline is anticipated to be released in 2022 (66).” This announcement was followed by the release of a PowerPoint Presentation entitled, “Update on the BSC\/NCIPC Workgroup,” on July 22, 2020, which elaborated on the process of choosing the new Opioid Workgroup (67). An additional update from October 13, 2020, identified the membership of the Opioid Workgroup – NCIPC BSC Committee Members (68). The updated and\/or expanded Pain Guideline was anticipated to be released in 2022 (66), but that timeframe was projected before the full impact of the COVID-19 Pandemic. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EIncreases in Overdose Deaths and CDC Data Flaws\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ccenter\u003E\u003Ci\u003EThe February 2021 MMWR Report\u003C\/i\u003E\u003C\/center\u003E\u003Cbr\u003E\u003Cbr\u003EWhile the world anxiously awaited word on any new or revised CDC Pain Guidelines, on February 12, 2021, the MMWR Report (1) mentioned at the top of this commentary quickly captured the attention of those already hungry for news from the CDC, including patients with chronic pain and clinicians who manage that pain. In the setting of a 1,040% increase in “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019 (1),” it seemed prudent to critically question PROP’s assertion that “The downward trends in new starts of chronic opioid treatment achieved by the 2016 guideline should be seen as a positive development that will encourage people to find alternative means of controlling chronic pain, which though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (64).” \u003Cbr\u003E\u003Cbr\u003EOn February 16, 2021, in what felt like an effort to draw attention away from the stark reality of the MMWR Report, PROP wrote a letter to AMA President, Susan R. Bailey, regarding “AMA’s Opposition to Dose \u0026 Duration Guidance for Opioid Prescribing (69),” based on AMA’s comments to Dr. Deborah Dowell in the CDC Open Docket (61). PROP concomitantly published this letter to the AMA as a “Rapid Response” to an article entitled, “UK recommendations on opioid stewardship (70, 71).” The letter alleged that AMA Opioid Policy was inappropriately influenced by donations from the pharmaceutical industry (69, 70). AMA President, Susan Bailey, quickly responded back to PROP, in a letter dated February 19, 2021, saying “With respect to the issue you raise in your letter, it might be helpful to point out that the CDC authors of the 2016 CDC Guideline themselves have recognized it has been misapplied (Italics mine; 72, 73).” Additionally, Bailey pointed out, “When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors. That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate. If you choose to cite the AMA’s policies in the future, we encourage you to cite them in their entirety to ensure accurate context (72),” and Bailey provided the link for the AMA’s comments to Deborah Dowell to guide PROP when referencing AMA policy in the future (62). \u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003E\u003Ccenter\u003EInaccurate CDC Data on Opioid Deaths\u003C\/center\u003E\u003C\/i\u003E\u003Cbr\u003E\u003Cbr\u003EJust a few weeks later, PROP’s troubles worsened, with the publication of an article by John Peppin and John J. Coleman in Pain Therapy (74) that detailed fundamental methodological shortcomings in CDC’s data on prescription overdose deaths (35). The authors held that “CDC erroneously reported prescription opioid overdose deaths in 2016 and for more than a decade before (74)” in a way that overestimated overdose deaths due to prescribed opioids. They further assert that “the CDC ignored the problem until 2016 data showed serious inconsistencies with other, more reputable, data for prescribing volumes of opioids (74).” Furthermore, in “2018, the U.S. Congress mandated the CDC to ‘’modernize’’ its system for reporting drug overdose deaths but this has not yet occurred (74).” They concluded: “For more than a decade, millions of Americans were misled into believing that—as a White House report once characterized it— ‘opiate overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers.’  Little did they know or suspect that the CDC’s coding of prescription painkillers included non-prescribed illicitly manufactured fentanyl and fentanyl analogs and non-prescribed methadone administered or dispensed to patients being treated for opioid use disorder (74).” \u003Cbr\u003E\u003Cbr\u003EThis report again exposed PROP’s and CDC’s false narrative that overprescribing of opioid analgesics had driven the US overdose crisis (74). In a predictable response, Andrew Kolodny reacted quickly to soften the crushing blow and establish some semblance of plausible deniability for PROP’s culpability. On March 22, 2021, Kolodny produced a webinar during which he “refuted” several alleged “myths and false narratives” about the opioid crisis (75). This presentation was swiftly characterized as “a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline (76).” For example, in a clear example of a Straw Man Argument (77), Kolodny alleged a myth that the “CDC Guideline forced millions of patients off opioids resulting in an epidemic of suicides (75),” when in fact both the CDC and FDA had publicly acknowledged the potential harms of forced tapers, acknowledging that the extent of the harm was not yet known (Italics mine, 42-45). In response to legitimate concerns about harms from polices influenced by PROP’s advocacy, one of its individual members had responded with gaslighting (75), informal fallacies (77) and deflection, aimed apparently at creating plausible deniability for their contribution to those harms. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EConclusion\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EDespite being turned back from an effort to bluntly reduce opioid prescribing by the FDA in 2013 based on a lack of scientific evidence for its position (17,18), PROP has had a disproportionate effect on opioid policy in the Untied States for almost a decade. PROP found a willing federal regulatory partner in the CDC, and while PROP may not have “secretly written” the 2016 CDC Pain Guidelines (75), they certainly enjoyed disproportionate representation on CDC’s review panels and Core Expert Group (23-25)  in a process that lacked transparency (22, 23, 26, 27). When the CDC admitted that its Pain Guideline had been widely misapplied (40) and joined the FDA in a call against forced opioid tapers (42, 43, 45), PROP doubled down on its rhetoric (46), dismissing legitimate concerns about potential harms in a performative manner (75) that encouraged their ongoing misapplication, while assailing PROP’s critics (76, 77).  All of this has occurred as PROP members have repeatedly concealed relevant conflicts of interest, including key conflicts that should have been disclosed during the process of drafting the CDC Pain Guidelines (48-54). \u003Cbr\u003E\u003Cbr\u003EGiven this, at a minimum, PROP should no longer enjoy a prominent role in guiding future opioid policy in the United States. This is a particularly urgent concern, as Roger Chou has been linked to authorship of CDC’s New Pain Guidelines, which have not yet been released to the public (78). Chou’s involvement in yet another set of Guidelines and CDC’s recurrent lack of transparency (79) in identifying the new Guidelines’ authors should alarm all advocates who support access to pain medications for all patients with a medically legitimate indication for opioid therapy. \u003Cbr\u003E\u003Cbr\u003EBeyond limiting PROP’s role in developing future, potentially harmful opioid policy, a reasonable individual would be justified in wondering to what extent PROP bears culpability for the harms that arose from misapplications of the 2016 CDC Pain Guidelines. In our country, civil suits – like class action lawsuits, for example – only require a preponderance of the evidence – that is something is “more likely than not” - as the burden of proof for liability. It is more likely than not that PROP’s efforts to affect opioid policy helped shape the CDC Guidelines, which CDC has admitted were misapplied harmfully (40). It is also more likely than not that PROP’s performative advocacy efforts contributed to misapplication of the CDC Guidelines. And it is more likely than not that widespread misapplication of the CDC Guidelines resulted in harms with attendant civil liability. This would expose PROP to civil liability with a potentially enormous settlement if a class action suit were to arise from those harmed by the misapplication of the CDC Guidelines. Perhaps that is why PROP member, Andrew Kolodny, and others have worked so hard recently to create plausibly deniability (75) in the wake of the damaging February 12, 2021, MMWR Report (2). \u003Cbr\u003E\u003Cbr\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/opioids\"\u003EPallimed posts about opioids.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/pain\"\u003EPallimed posts about pain and pain control.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/kollas\"\u003EPallimed posts by Dr. Kollas click here.\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003EDr. Kollas is board certified in internal medicine and provides pallative and supportive care in Orlando, FL.. He first wrote about his personal experiences with chronic illness and pain in a 1997 article in the “On Being a Patient” series in Annals of Internal Medicine. \u003Ca href=\"https:\/\/twitter.com\/ChadDKollas?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor\" target=\"_blank\"\u003EYou can find him on Twitter at @ChadDKollas\u003C\/a\u003E.\u003C\/i\u003E\u003Cbr\u003E\u003Cbr\u003ETo cite this article: Kollas C. Mandated PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences. Pallimed. May 2021. Available at: https:\/\/www.pallimed.org\/2021\/05\/props-disproportionate-influence-on-us.html \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003ECorrection 5\/4\/2021:\u003C\/b\u003E A date was incorrectly included in the original article as \"April 9, 2021,\" which was incorrect. It was changed to the correct date of \"April 9, 2019.\" \u003Cbr\u003E\u003Cbr\u003EAddition 5\/6\/2021: A Twitter user was able to find the PDF link to Reference number 40. The reference was updated with this link. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EConflict of Interest (submitted upon publication, added here 5\/4): \u003C\/b\u003EDr. Kollas had submitted a Conflict of Interest statement when submitting this article for publication. It was not originally included in error in the original article here due to editor error. You can find the conflict of interest statement here - https:\/\/twitter.com\/ChadDKollas\/status\/1389616181762478080. We have a copy of the COI statement, if this link ever is removed or in error. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EReferences\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E1.\tMattson CL, et al. MMWR, February 12, 2021. 70(6):202-7 (or see https:\/\/www.cdc.gov\/mmwr\/volumes\/70\/wr\/pdfs\/mm7006-H.pdf). \u003Cbr\u003E\u003Cbr\u003E2.\tSee https:\/\/twitter.com\/BethDarnall\/status\/1366901343642742784. \u003Cbr\u003E\u003Cbr\u003E3.\tSee https:\/\/twitter.com\/ChadDKollas\/status\/1365661703191560192. \u003Cbr\u003E\u003Cbr\u003E4.\tSee the CDC Pain Guidelines at https:\/\/www.cdc.gov\/mmwr\/volumes\/65\/rr\/rr6501e1.htm. \u003Cbr\u003E\u003Cbr\u003E5.\tSee https:\/\/twitter.com\/supportprop\/status\/1362043581544947712. \u003Cbr\u003E\u003Cbr\u003E6.\tOld, JL. Fam Pract Manag. 2011 Nov-Dec;18(6):31-35 (or see https:\/\/www.aafp.org\/fpm\/2011\/1100\/p31.html. \u003Cbr\u003E\u003Cbr\u003E7.\tVon Korff M, et al. Ann Intern Med. 2011 September 6; 155(5): 325–328; See https:\/\/www.acpjournals.org\/doi\/10.7326\/0003-4819-155-5-201109060-00011?url_ver=Z39.88-2003\u0026rfr_id=ori%3Arid%3Acrossref.org\u0026rfr_dat=cr_pub++0pubmed\u0026. \u003Cbr\u003E\u003Cbr\u003E8.\tPROP Petition to FDA, 2012, See https:\/\/www.citizen.org\/wp-content\/uploads\/migration\/2048.pdf. \u003Cbr\u003E\u003Cbr\u003E9.\tSee https:\/\/www.regulations.gov\/document\/FDA-2012-P-0818-0002. \u003Cbr\u003E\u003Cbr\u003E10.\tSee https:\/\/www.joepaduda.com\/2012\/08\/14\/responsible_opi\/. \u003Cbr\u003E\u003Cbr\u003E11.\tSee food-and-drug-administration-follow-up-letter-to-relabeling-petition-clarification-of-asam-position-nbsp-september-13-2012.pdf. \u003Cbr\u003E\u003Cbr\u003E12.\tOriginally posted at http:\/\/updates.pain-topics.org\/2012\/08\/group-petitions-fda-to-change-opioid.html, but that link is not operational; the article is currently referenced at https:\/\/painpolicy.wordpress.com\/2012\/08\/03\/why-the-fda-shouldnt-change-the-labeling-of-opioid-analgesics\/. \u003Cbr\u003E\u003Cbr\u003E13.\tPortenoy RK. Letter to Nirav R. Shah, MD, MPH, Commissioner, New York State Department of Health. August 16, 2012. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E14. \tSee https:\/\/www.google.com\/url?sa=t\u0026rct=j\u0026q=\u0026esrc=s\u0026source=web\u0026cd=\u0026ved=2ahUKEwi8i4imqMzvAhU_TDABHQS7Cc4QFjAAegQIBRAD\u0026url=https%3A%2F%2Fwww.asahq.org%2F-%2Fmedia%2Fsites%2Fasahq%2Ffiles%2Fpublic%2Fadvocacy%2Ffederal-activities%2Fregulatory-activities%2Fpain-medicine%2Fasa-letter-fda-prop-8-22-12.pdf%3Fla%3Den%26hash%3D09DC35AB25C0C8F30807578C2038EA0244B7D7C9\u0026usg=AOvVaw1-eZoU2_-k4xbDsC4EYdjT. \u003Cbr\u003E\u003Cbr\u003E15.\tGrabois M. Letter to Dockets Management Branch, Food and Drug Administration. August 12, 2012. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E16.\tSee https:\/\/www.acttion.org\/static\/docs\/aps_letter.pdf; referenced at https:\/\/www.acttion.org\/news\/november-26-2013-american-pain-society-letter-to-fda-commissioner-hamburg-about-immpact-and-acttion). \u003Cbr\u003E\u003Cbr\u003E17.\tSee https:\/\/www.supportprop.org\/wp-content\/uploads\/2014\/12\/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_Partial_Petition_Approval_and_Denial.pdf. \u003Cbr\u003E\u003Cbr\u003E18.\tSee http:\/\/www.fdalawblog.net\/2013\/09\/fda-grants-prop-petition-in-part-proposes-new-labeling-and-requires-post-marketing-studies-for-erla\/. \u003Cbr\u003E\u003Cbr\u003E19.\tSee http:\/\/www.supportprop.org\/wp-content\/uploads\/2014\/01\/PROP_OpioidPrescribing.pdf. \u003Cbr\u003E\u003Cbr\u003E20.\tSee http:\/\/www.supportprop.org\/wp-content\/uploads\/2014\/12\/PA_3_29_13_FSMB.pdf. \u003Cbr\u003E\u003Cbr\u003E21.\tSee https:\/\/www.cdc.gov\/injury\/pdfs\/fundedprograms\/Response_to_Constituent_Comment_CDC_Prescribing_Guideline.pdf. \u003Cbr\u003E\u003Cbr\u003E22.\tAnson P. CDC Maintains Secrecy Over Opioid Guidelines. Pain News Network, September 18. 2015. See https:\/\/www.painnewsnetwork.org\/stories\/2015\/9\/18\/cdc-maintains-secrecy-over-opioid-guidelines. \u003Cbr\u003E\u003Cbr\u003E23.\tAnson P.  Chronic Pain Groups Blast CDC for Opioid Guidelines. Pain News Network, September 22, 2015. See https:\/\/www.painnewsnetwork.org\/stories\/2015\/9\/22\/chronic-pain-groups-blast-cdc-for-opioid-guidelines. \u003Cbr\u003E\u003Cbr\u003E24.\tAnson P. Special Interest Groups Behind CDC Opioid Guidelines. Pain News Network, September 24, 2015. See https:\/\/www.painnewsnetwork.org\/stories\/2015\/9\/24\/3xz1qq23yuilyeluz63kgwckplwh21. \u003Cbr\u003E\u003Cbr\u003E25.\tAnson P. PROP Helped Draft the CDC Guidelines. Pain News Network, September 21, 2015. See https:\/\/www.painnewsnetwork.org\/stories\/2015\/9\/21\/prop-helped-draft-cdc-opioid-guidelines. \u003Cbr\u003E\u003Cbr\u003E26.\tMadara JL. Letter to Thomas Freiden, Director, Centers for Disease Control and Prevention. October 1, 2015. (PDF copy available on request from article’s author). \u003Cbr\u003E\u003Cbr\u003E27.\tPatient Quality of Life Coalition. Letter to The Honorable Lamar Alexander, Chairman, Committee of Health, Education, Labor and Pensions, United States Senate. November 13, 2015. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E28.\tSee https:\/\/www.federalregister.gov\/documents\/2015\/12\/14\/2015-31375\/proposed-2016-guideline-for-prescribing-opioids-for-chronic-pain. \u003Cbr\u003E\u003Cbr\u003E29.\tSamp R. CDC Bows To Demands For Transparency And Public Input On Draft Opioid-Prescribing Guidelines. Forbes, December 15, 2015. See http:\/\/www.forbes.com\/sites\/wlf\/2015\/12\/15\/cdc-bows-to-demands-for-transparency-and-public-input-on-draft-opioid-prescribing-guidelines\/#36c587e1122a. \u003Cbr\u003E\u003Cbr\u003E30.\tNorman B. POLITICO Pro: CDC opens opioid prescription guidelines to public comment. Politico, December 11, 2015. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E31.\tLin DH, et al. Financial Conflicts of Interest and the Centers for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain. JAMA Internal Medicine, March 2017; 177(3):427-8. \u003Cbr\u003E\u003Cbr\u003E32.\tFiore K. CDC Comes Down Hard on Opioids for Chronic Pain — Urges physicians not to use opioids first-line for chronic pain. MedPage Today, March 15, 2016. See https:\/\/www.medpagetoday.com\/publichealthpolicy\/publichealth\/56745. \u003Cbr\u003E\u003Cbr\u003E32.\tSee http:\/\/blog.aapainmanage.org\/academys-response-center-disease-controls-guideline-prescribing-opioids-chronic-pain\/. \u003Cbr\u003E\u003Cbr\u003E33.\tSee https:\/\/usrtk.org\/wp-content\/uploads\/2016\/10\/CDC_SPIDER_Letter-1.pdf. \u003Cbr\u003E\u003Cbr\u003E34.\tGillam C. The CDC is being influenced by corporate and political interests. The Hill, October 17, 2016. See https:\/\/thehill.com\/blogs\/pundits-blog\/healthcare\/301432-the-cdc-is-being-being-influenced-by-corporate-and-political . \u003Cbr\u003E\u003Cbr\u003E35.\tSeth P, et al. Quantifying the Epidemic of Prescription Opioid Overdose Deaths. AJPH, April 2018; 108(4):500-2. See https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5844400\/pdf\/AJPH.2017.304265.pdf. \u003Cbr\u003E\u003Cbr\u003E36.\tDarnall BD, et al (including Kollas CD). International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering. Pain Medicine, 2018; 0:1-4. See https:\/\/pubmed.ncbi.nlm.nih.gov\/30496540\/. \u003Cbr\u003E\u003Cbr\u003E37.\tNicholson KM, Hoffman DE, Kollas CD. Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients. Stat News, December 6, 2018. See https:\/\/www.statnews.com\/2018\/12\/06\/overzealous-use-cdc-opioid-prescribing-guideline\/. \u003Cbr\u003E\u003Cbr\u003E38.\tSee Resolution 235 at https:\/\/www.ama-assn.org\/system\/files\/2018-11\/i18-refcomm-b-annotated.pdf. \u003Cbr\u003E\u003Cbr\u003E39.\tCarlson RW, et al. Letter to Deborah Dowell, Chief Medical Officer, Opioid Response Coordinating Unit, CDC National Center for Injury Prevention and Control. February 13, 2019. See https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2019-NCCN-ASCO-ASH-Letter-CDC.pdf. \u003Cbr\u003E\u003Cbr\u003E40.\tDowell D. Centers for Disease Control and Prevention. Letter to NCCN, ASCO, ASH, February 28, 2019. https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2019-CDC-Opioid-Guideline-Clarification-Letter-to-ASCO-ASH-NCCN.pdf \u003Cbr\u003E\u003Cbr\u003E41.\tHealth Professionals for Patients in Pain (HP3), led by Alford DP (and including Kollas CD). Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation. March 6, 2019. See https:\/\/healthprofessionalsforpatientsinpain.org\/the-letter-1. \u003Cbr\u003E\u003Cbr\u003E42.\tCenters for Disease Control and Prevention. Letter to Daniel P. Alford MD MPH, Professor of Medicine, Brown University Medical Campus. April 10, 2019. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E43.\tFDA Drug Safety Communications. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. See https:\/\/www.fda.gov\/media\/122935\/download. \u003Cbr\u003E\u003Cbr\u003E44.\tFDA Drug Safety Podcast. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019. See https:\/\/www.fda.gov\/drugs\/fda-drug-safety-podcasts\/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes#:~:text=On%20April%209%2C%202019%20FDA,%2C%20psychological%20distress%2C%20and%20suicide. \u003Cbr\u003E\u003Cbr\u003E45.\tCDC Media Relations. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Embargoed Until: Wednesday, April 24, 2019, 5 PM, EDT. See https:\/\/www.cdc.gov\/media\/releases\/2019\/s0424-advises-misapplication-guideline-prescribing-opioids.html. \u003Cbr\u003E\u003Cbr\u003E46.\tDowell D, Haegerich T, Chou R. No Safecuts to Safer Opioid Prescribing. N Engl J Med 2019; 380:2285-2287. https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp1904190. \u003Cbr\u003E\u003Cbr\u003E47.\tDepartment of Justice, Office of Public Affairs. Justice Department Obtains $1.4 Billion from Reckitt Benckiser Group in Largest Recovery in a Case Concerning an Opioid Drug in United States History. July 11, 2019. See https:\/\/www.justice.gov\/opa\/pr\/justice-department-obtains-14-billion-reckitt-benckiser-group-largest-recovery-case. \u003Cbr\u003E\u003Cbr\u003E48.\tMcGray D. The Bitter Pill. Wired, April 1, 2005. See https:\/\/www.wired.com\/2005\/04\/bupe\/. \u003Cbr\u003E\u003Cbr\u003E49.\tSee https:\/\/web.archive.org\/web\/20150329132943\/http:\/\/www.rb.com\/rb-complete-demerger-of-indivior. \u003Cbr\u003E\u003Cbr\u003E50.\tSee https:\/\/medium.com\/@jmkillingworth\/grandmas-on-smack-and-other-unsavory-tactics-from-prop-benefactor-reckitt-benckiser-group-fb5ee76a3ed5. \u003Cbr\u003E\u003Cbr\u003E51.\tSee https:\/\/www.govinfo.gov\/content\/pkg\/CHRG-115shrg31264\/pdf\/CHRG-115shrg31264.pdf. \u003Cbr\u003E\u003Cbr\u003E52.\tJAMA. 2019 Sep 4 : e1914523. See https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6727681\/?report=printable. \u003Cbr\u003E\u003Cbr\u003E53.\tChou R, et al. Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Internal Med, Sept 17, 2019;171(6):427-430. See https:\/\/www.acpjournals.org\/doi\/pdf\/10.7326\/M19-1488. \u003Cbr\u003E\u003Cbr\u003E54.\tAnson P. PROP President Discloses Conflicts of Interest. Pain News Network, November 19, 2019. See https:\/\/www.painnewsnetwork.org\/stories\/2019\/11\/12\/prop-president-discloses-conflicts. \u003Cbr\u003E\u003Cbr\u003E55\tSee https:\/\/emergency.cdc.gov\/coca\/transcripts\/2016\/call-transcript-080316.asp. \u003Cbr\u003E\u003Cbr\u003E56.\tPersonal communication with Sharon Davies, Letter Editor, British Medical Journal. March 15, 2021, at 2:05 PM ET. (Copy of e-mail available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E57.\tAgency for Healthcare Research and Quality, US Department of Health and Human Services. Opioid Treatment for Chronic Pain.  AHRQ Publication No. 20-EHC011, April 2020. See https:\/\/effectivehealthcare.ahrq.gov\/sites\/default\/files\/pdf\/opioids-chronic-pain.pdf. \u003Cbr\u003E\u003Cbr\u003E58.\tAnson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020.  https:\/\/www.painnewsnetwork.org\/stories\/tag\/Roger+Chou \u003Cbr\u003E\u003Cbr\u003E59.\tSee https:\/\/www.regulations.gov\/document\/CDC-2020-0029-0001. \u003Cbr\u003E\u003Cbr\u003E60.\tSee https:\/\/www.regulations.gov\/docket\/CDC-2020-0029. \u003Cbr\u003E\u003Cbr\u003E61.\tAmerican Academy of Hospice \u0026 Palliative Medicine. Letter to Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention. RE: Management of Acute and Chronic Pain: Request for Comment; Docket No. CDC–2020– 0029. June 16, 2020. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E62.\tMadara JL. Letter to Deborah Dowell, MD, MPH. Chief Medical Officer, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention. Re: Docket No. CDC-2020-0029. June 16, 2020. See https:\/\/searchlf.ama-assn.org\/undefined\/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2020-6-16-Letter-to-Dowell-re-Opioid-Rx-Guideline.pdf. \u003Cbr\u003E\u003Cbr\u003E63.\tAMA urges CDC to revise opioid prescribing guideline (Press Release). June 18, 2020. See https:\/\/www.ama-assn.org\/press-center\/press-releases\/ama-urges-cdc-revise-opioid-prescribing-guideline. \u003Cbr\u003E\u003Cbr\u003E64.\tBallantyne JC et al. Letter to Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention. Re: Docket No. CDC-2020-0029- Management of Acute and Chronic Pain. See http:\/\/www.supportprop.org\/wp-content\/uploads\/2020\/06\/PROP-Comment-CDC-Docket-2020.pdf?fbclid=IwAR2SCNj6MTLhYml9TbthlEm8nfzXQpEQX4tmCGSKFAkptZk42p-OOsKZHZc. \u003Cbr\u003E\u003Cbr\u003E65.\tFudin J. Chronic Opioid Patients Speak Out Against PROP. PainDr, August 12, 2012. See https:\/\/paindr.com\/chronic-opioid-patients-speak-out-against-prop\/ in Comments. \u003Cbr\u003E\u003Cbr\u003E66.\tSee https:\/\/www.cdc.gov\/injury\/pdfs\/bsc\/OWG_Terms-of-Ref_FINAL-7-6-2020-r.pdf. \u003Cbr\u003E\u003Cbr\u003E67.\tRoss M. Update on the BSC\/NCIPC Opioid Workgroup Formation. Board of Scientific Counselors Meeting, July 22, 2020. See https:\/\/www.cdc.gov\/injury\/pdfs\/bsc\/Ross_OWG-Update-7-7-2020-508.pdf. \u003Cbr\u003E\u003Cbr\u003E68.\tSee https:\/\/www.cdc.gov\/injury\/pdfs\/bsc\/OWG-Roster-External-10-13-2020-FINAL-a.pdf. \u003Cbr\u003E\u003Cbr\u003E69.\tBallantyne JC, et al. Letter to Susan R. Bailey, MD, President, American Medical Association. RE: AMA’s Opposition to Dose \u0026 Duration Guidance for Opioid Prescribing. February 16, 2021. (PDF copy available on request from this article’s author). \u003Cbr\u003E\u003Cbr\u003E70.\tBallantyne JC, et al. Rapid Response: Letter from Physicians for Responsible Opioid Prescribing (PROP) to the American Medical Association (AMA) -- RE: AMA’s Opposition to Dose \u0026 Duration Guidance for Opioid Prescribing. BMJ 2021;372:m4901. See https:\/\/www.bmj.com\/content\/372\/bmj.m4901\/rr-1. \u003Cbr\u003E\u003Cbr\u003E71.\tLevy N, et al. UK recommendations on opioid stewardship. BMJ 2021 Jan 5;372:m4901. See also https:\/\/pubmed.ncbi.nlm.nih.gov\/33402365\/. \u003Cbr\u003E\u003Cbr\u003E72.\tBailey SR. Letter to Physicians for Responsible Opioid Prescribing (PROP). February 19, 2021. https:\/\/static1.squarespace.com\/static\/54d50ceee4b05797b34869cf\/t\/6036d35738d4d95a0458ab65\/1614205783776\/AMA+letter+to+PROP.pdf. \u003Cbr\u003E\u003Cbr\u003E73.\tAnson P. AMA Scolded for Seeking Changes in CDC Opioid Guideline. Pain Network News, February 17, 2021. See https:\/\/www.painnewsnetwork.org\/stories\/2021\/2\/17\/prop-attacks-ama-for-seeking-changes-in-cdc-opioid-guideline-nbsp. \u003Cbr\u003E\u003Cbr\u003E74.\tPepin JF and Coleman JJ. CDC’s Efforts to Quantify Prescription Opioid Overdose Deaths Fall Short. Pain Ther 2021 Mar 24;1-14. Published online ahead of print on March 24, 2021. See https:\/\/pubmed.ncbi.nlm.nih.gov\/33761120\/ or https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40122-021-00254-z.pdf. \u003Cbr\u003E\u003Cbr\u003E75.\tSee screen capture by Carrie Judy at  https:\/\/twitter.com\/life_is_art___\/status\/1374453671136616448\/photo\/1. \u003Cbr\u003E\u003Cbr\u003E76.\tAnson P. Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’. Pain News Network, March 24, 2021. See  https:\/\/www.painnewsnetwork.org\/stories\/2021\/3\/24\/kolodny-critics-of-cdc-opioid-guideline-twisting-the-facts. \u003Cbr\u003E\u003Cbr\u003E77.\tSee, for example https:\/\/en.wikipedia.org\/wiki\/Straw_man. \u003Cbr\u003E\u003Cbr\u003E78.\tAnson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. See https:\/\/www.painnewsnetwork.org\/stories\/2020\/4\/20\/prop-linked-to-new-federal-opioid-study. \u003Cbr\u003E\u003Cbr\u003E79.\tAnson P. CDC Won’t Say Who is Writing Update of Opioid Guideline. Pain News Network, April 5, 2021. See https:\/\/www.painnewsnetwork.org\/stories\/2021\/4\/4\/cdc-wont-say-who-is-writing-update-of-opioid-guideline.  \u003Cbr\u003E\u003Cbr\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"Dr. Chad Kollas systematically analyzes the role PROP has played in shaping opioid policy in the US.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/1.bp.blogspot.com\/-QSZPR6GtcdM\/YJBwbOpJ-eI\/AAAAAAAAAao\/Fp6pV5FzlWsOJHgmhHvFH-d0mvVKo_uvwCLcBGAsYHQ\/s320\/OUD%2BPost%2B%25286%2529.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2021\/05\/props-disproportionate-influence-on-us.html\" \/\u003E"},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/6789906096915190345"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/6789906096915190345"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2021\/05\/props-disproportionate-influence-on-us.html","title":"PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences"}],"author":[{"name":{"$t":"Pallimed Editor"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/11358791266969988517"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"16","height":"16","src":"https:\/\/img1.blogblog.com\/img\/b16-rounded.gif"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-QSZPR6GtcdM\/YJBwbOpJ-eI\/AAAAAAAAAao\/Fp6pV5FzlWsOJHgmhHvFH-d0mvVKo_uvwCLcBGAsYHQ\/s72-c\/OUD%2BPost%2B%25286%2529.png","height":"72","width":"72"}},{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-8390492795192105894"},"published":{"$t":"2019-11-18T14:26:00.000-06:00"},"updated":{"$t":"2019-11-18T16:03:04.214-06:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"kollas"},{"scheme":"http://www.blogger.com/atom/ns#","term":"opioid"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"quality improvement"},{"scheme":"http://www.blogger.com/atom/ns#","term":"statte"}],"title":{"type":"text","$t":"Mandated Queries of the Florida Prescription Drug Monitoring Program:  A Three-Month Experience from a Cancer Center-Based Outpatient Palliative Medicine Clinic"},"content":{"type":"html","$t":"\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/1.bp.blogspot.com\/-wdD41WyFIPc\/XdL4TF-Q14I\/AAAAAAACtl0\/eMn1NvSMDo8lyXint7d90RmPDSS3JiNyACLcBGAsYHQ\/s1600\/Mandated%2BQueries%2Bof%2Bthe%2BFlorida%2BPrescription%2BDrug%2BMonitoring%2BProgram_%2BEarly%2BExperiences%2Bfrom%2Ba%2BCancer%2BCenter-based%2BOutpatient%2BPalliative%2BMedicine%2BClinic.png\" imageanchor=\"1\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg border=\"0\" src=\"https:\/\/1.bp.blogspot.com\/-wdD41WyFIPc\/XdL4TF-Q14I\/AAAAAAACtl0\/eMn1NvSMDo8lyXint7d90RmPDSS3JiNyACLcBGAsYHQ\/s320\/Mandated%2BQueries%2Bof%2Bthe%2BFlorida%2BPrescription%2BDrug%2BMonitoring%2BProgram_%2BEarly%2BExperiences%2Bfrom%2Ba%2BCancer%2BCenter-based%2BOutpatient%2BPalliative%2BMedicine%2BClinic.png\" width=\"320\" height=\"320\" data-original-width=\"800\" data-original-height=\"800\" \/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Chad Kollas (\u003Ca href=\"http:\/\/twitter.com\/ChadDKollas\"\u003E@ChadDKollas\u003C\/a\u003E) \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EBackground and Introduction\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EOn July 2, 2018, Florida implemented a new law requiring all licensed physicians to query the state’s prescription drug monitoring program (PDMP), known as the Electronic Florida Online Reporting of Controlled Substances Evaluation (E-FORSCE), before prescribing controlled medications, including opioid analgesics. Like many other recent state and federal policies, \u003Ca href=\"https:\/\/web.archive.org\/save\/https:\/\/www.floridatrend.com\/article\/23116\/gov-scott-to-propose-major-legislation-and-50-million-investment-to-combat-opiod-abuse\"\u003Ethis law was intended to reduce deaths from prescription opioid overdoses\u003C\/a\u003E. \u003Cbr\u003EOur outpatient palliative medicine clinic initiated a quality improvement (QI) project to characterize the effects of the new and identify opportunities to improve palliative care in the setting of its implementation. We posted the results of the first month’s queries in an \u003Ca href=\"https:\/\/www.pallimed.org\/2018\/09\/mandated-queries-of-florida.html\"\u003Eearlier Pallimed post, published in September 2018\u003C\/a\u003E. This article represents the findings from the queries over the first three months’ queries and brings further clarity to our initial findings. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EMethods\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\tThis quality improvement (QI) project was reviewed and approved by the Orlando Health\/UFHealth Cancer Center Joint Oncology Committee for 2018-19. We began recording results of all E-FORSCE queries occurring after the law’s implementation of July 1, 2018 through September 30, 2018. We informed each patient that the PDMP query had become mandatory in Florida, and we discussed the results of each query with each patient. Each query examined the last 12 months of the patients’ controlled medication prescriptions. \u003Cbr\u003E\u003Cbr\u003EWe documented patients’ demographics, including each patient’s age, gender and limited identifying information, such as patient names and identification numbers, which were subsequently de-identified for statistical analyses. We recorded patients’ main diagnosis and pain symptoms, the number of prescribers listed by the PDMP as well as the dose of the patient’s opioid analgesia, measured in average daily morphine milligram equivalents, as provided by the state database. We also noted pain ratings with and without medications, including opioids and non-opioids, as well as the difference between those ratings. Beginning on September 6, 2018, E-FORSCE began displaying each queried patient’s “NarxCare Overdose Risk Score,” so we began record those scores as part of this QI project. According to its creator, Appriss Health, the \u003Ca href=\"https:\/\/florida.pmpaware.net\/narx-content\/content\/narxcare2\/explain-overdose-risk-score.pdf\"\u003ENarxScore is an overdose risk score [that] is a predictive score for unintentional overdose death,” and that it is “designed to draw awareness to the presence of significant PMP data.”\u003C\/a\u003E, although there are no studies in the medical literature assessing its validity as a predictive tool. \u003Cbr\u003E\u003Cbr\u003EWe classified the numbers of each patient’s prescribers binarily (one prescriber or more than one prescriber), and usage sage patterns were classified ordinally as medically legitimate, aberrant or medically illegitimate. Medically legitimate patterns reflected 1) cross-coverage of medication renewals, 2) evolving sites of care (such as a transitioning into oncologic care after treatment of cancer pain before establishing a cancer diagnosis), 3) prescribing of non-opioid controlled medications by primary care physicians (PCPS) and\/or their cross-coverage and 4) prescribing within the policies and rules of the PMC. \u003Cbr\u003E\u003Cbr\u003EWe defined medically illegitimate patterns as involving 1) duplicative prescriptions (multiple prescriptions within close temporal proximity at multiple geographic site or multiple providers), 2) patterns unexplained by under-treatment and\/or an inability to fill prescriptions in full quantity, or 3) behavior(s) prohibited by the policies and rules of the PMC. We used the category of aberrancy to describe situations which did not fall cleanly into the definitions of medically-legitimate or illegitimate usage. \u003Cbr\u003E\u003Cbr\u003EAdditionally, we classified opioid dosages ordinally, using the three planned categories for daily MME dose that used by the \u003Ca href=\"https:\/\/www.painnewsnetwork.org\/stories\/2018\/4\/2\/medicare-finalizes-plan-to-reduce-high-dose-opioids\"\u003ECenters for Medicare and Medicaid Services (CMS) in its opioid prescribing rules for 2019\u003C\/a\u003E: less than 90 MME, 90-200 MME or greater than 200 MME. We also allowed for individualized comments regarding any unexpected or unusual findings when performing a PDMP query. The mean MME over the last 30 days was usually obtained from the PDMP, but was calculated based on prescribing instructions when not provided explicitly by that database. \u003Cbr\u003E\u003Cbr\u003EFinally, we recorded patients’ self-reported pain ratings based on a 0-10\/10 scale, with 0 indicating no pain and 10 indicating excruciating pain (or the most severe pain the patient had ever experienced). We recorded patients’ pain ratings with and without cancer pain medications, clarifying that we meant pain medications being prescribed medically for their cancer pain. In our clinic, the usual goal for cancer pain control is achieving a pain rating of 4-5 out of 10, not the achievement of a pain-free state, an approach that evolved from the \u003Ca href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/392989\"\u003EAmerican Pain Society’s recommendations for managing cancer pain\u003C\/a\u003E. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EResults\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003E\u003Ci\u003EDemographics\u003C\/i\u003E\u003Ci\u003E\u003C\/i\u003E\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EWe queried the Florida PDMP for a total of 359 outpatients from July 5, 2018 to October 4, 2018. The vast majority of these patients (90.3%) reported cancer-related pain, while the rest reported chronic pain from other conditions for which they received outpatient palliative care within the cancer center, including chronic pain from sickle cell disease (21 patients, 5.8% of total). The patients’ average age was 56.3 years old (range of 21 to 85) and 61.3% of them identified as female. Twenty-five of the 359 patients (7%) represented new consultations to the Palliative Medicine Clinic. \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003E\u003Ci\u003EPrescribers and Usage Patterns \u003C\/i\u003E\u003Ci\u003E\u003C\/i\u003E\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EAbout 76% of the patients had more than one prescriber listed in the PDMP, while 21% had a single prescriber for controlled medications. Only two patients (0.6%) exhibited possible aberrancy: one had a query showing 15 prescribers, and the other was a healthcare professional who had self-prescribed renewals of anxiolytic medications (physicians in Florida are not permitted to prescribe to themselves, because Florida law specifies that a physician-patient relationship must involve two people; self-prescribing may be permissible in other states, albeit ethically questionable). The patient with 15 prescribers was ultimately not found to be using opioids illegitimately, but rather was participating in the healthcare system in a fragmented way, through two, parallel sets of third-party payers (health insurance and motor vehicle insurance). The self-prescribing physician already had received legitimate prescriptions for his medication from other physicians, but he had called in over-lapping renewals for the sake of geographic convenience; he stopped this behavior when reminded about its questionable nature. There were no patients whose prescribing pattern suggested otherwise illegal or medically-illegitimate behavior, such as “doctor shopping.”  \u003Cbr\u003E\u003Cbr\u003EIn the first month of PDMP queries we had uncovered four cases in which the state PDMP was demonstrably incorrect, with an error rate of 3.2% in the database. At the completion of three months of queries, we identified 17 errors, which represented an error rate of 4.7% in the E-FORSCE database. We did not define as errors instances in which the E-FORSCE database misidentified a single prescriber as multiple prescribers, a very frequent occurrence within the database (for example, I was often identified as two prescribing physicians, under the names “Chad Kollas” and “Chad Kollas Kollas”), although the database does appear to use such duplication errors when calculating NarxScores. The most common errors were as follows: 1) no prescription listed in the PDMP when a prescription was clearly provided based on objective documentation (such as a filled medication bottle from a pharmacy listing the prescription date and prescriber’s name which were absent from the database), which accounted for 10 cases (2.8% of all cases); 2) grossly incorrect calculation of MME in 4 cases (1.1 % of all cases); and, 3) verifiably incorrect prescriber misattributed to the prescription, which occurred in 3 cases (0.8% of all cases). \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003E\u003Ci\u003EOpioid Dose and MME Distribution\u003C\/i\u003E\u003Ci\u003E\u003C\/i\u003E\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EThe mean opioid analgesic dose for all of the patients was 268 MME per day, but the median dose was 126 MME per day, with a very wide range of daily dosages (6 MME to 2880 MME; SD = 368.1). The distribution of Daily MME is shown in Table 1 (below).  \u003Cbr\u003E\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/1.bp.blogspot.com\/-HSjHpkWYmKk\/XdL5_vMn0OI\/AAAAAAACtmE\/4er5WAYt_pQXD7ZmnNt-Yx1crOV7ixQpACLcBGAsYHQ\/s1600\/table%2Bopioid%2Bflorida.PNG\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"\u003E\u003Cimg border=\"0\" src=\"https:\/\/1.bp.blogspot.com\/-HSjHpkWYmKk\/XdL5_vMn0OI\/AAAAAAACtmE\/4er5WAYt_pQXD7ZmnNt-Yx1crOV7ixQpACLcBGAsYHQ\/s640\/table%2Bopioid%2Bflorida.PNG\" width=\"600\" height=\"168\" data-original-width=\"1168\" data-original-height=\"306\" \/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003Cbr\u003ETen patients (2.8%) had received opioid analgesics within the last year, but were no longer taking them at the time of the PDMP query. Three patients (0.8%) died from their cancer during the QI project. \u003Cb\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003EPain Ratings and NarxCare Overdose Risk Scores\u003C\/i\u003E\u003Ci\u003E\u003C\/i\u003E\u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003EThe patients’ mean pain rating without taking any pain medications was 8.9 out of 10 (SD = 1.2, Median = 9.0). The patient’s mean pain rating when taking their prescribed cancer pain medications was 3.9 out of 10 (SD 1.4, Median = 4.0), with an average reduction in pain rating was 5.0 points (SD = 1.5, Median = 5.0). This represented an average in reduction in pain of 56.3% with usage of the prescribed analgesic regimen. We recorded NarxCare Overdose Risk Scores for 144 of the 359 outpatients included in the QI project, as this measurement was first added to the E-FORSCE database in the third month of the project. The patients’ mean NarxCare Overdose Risk Score was 421 (median = 410, SD = 156.3). The \u003Ca href=\"https:\/\/web.archive.org\/web\/20191118200847\/https:\/\/florida.pmpaware.net\/narx-content\/content\/narxcare2\/explain-overdose-risk-score.pdf\"\u003EE-FORSCE website recommends co-prescribing of naloxone to NarxCare Overdose Risk Scores greater than 450\/999 and mentions that the 450\/999 score correlates with an approximate CDC MED Equivalent of just 50 mg\/day\u003C\/a\u003E.   \u003Cbr\u003E\u003Cbr\u003E\u003Cb\u003EDiscussion and Policy Implications \u003C\/b\u003E\u003Cbr\u003E\u003Cbr\u003E\tIn theory, the Florida PDMP aspires to improve patient safety by embracing the concept that patients are best served by using a single prescriber for medically-appropriate controlled pain medications. Accordingly, each patient in our palliative medicine clinic receives written educational material describing the policies and procedures of the clinic, including a directive encouraging them to receive prescriptions for controlled pain medications from a single prescriber and use a single pharmacy to fill them. Our QI projected showed, however, that about three-quarters of outpatients in a palliative medicine clinic (PMC) housed within a regional cancer center had PDMP queries showing multiple prescribers for their controlled medications (even when account for errors in misidentifying a single prescriber as multiple prescribers). Only 21% of patient queries revealed a single prescribing physician. Fortunately, after careful investigation of each PDMP report, we learned that the vast majority of the patients were taking controlled medications in a medically legitimate way, with only two patients exhibiting medication aberrancy and no patients demonstrating medically inappropriate behavior. This observation seemed to reflect a frequently fragmented pattern of medical care rather than patient misbehavior. Based on patient comments during clinic encounters, the reluctance of physicians to prescribe opioid analgesics, even in a medically appropriate situation, often resulted in the provision of multiple, back-to-back short-term prescriptions, which led to an increased number of prescribers over a relatively short period of time. \u003Cbr\u003E\u003Cbr\u003EMuch of the \u003Ca href=\"https:\/\/web.archive.org\/save\/https:\/\/www.floridatrend.com\/article\/23116\/gov-scott-to-propose-major-legislation-and-50-million-investment-to-combat-opiod-abuse\"\u003Ereasoning behind Florida mandating a prescriber query of the PDMP was to uncover inappropriate patient behavior\u003C\/a\u003E, which implicitly suggests the state believed that the rate of illegal behavior in patients was high. Our QI project suggests, however, that in a population of patients in an outpatient palliative medicine clinic, the risk of aberrancy is very low. Our QI project also suggests that the error rate of the Florida PDMP database (4.7%) was more than quadruple our patients’ aberrancy rate (0.6%) with no cases of medically inappropriate behavior identified. Given this, we express profound concern that Florida’s PDMP query requirements may worsen existing opioid stigma, making it even more difficult for palliative care patients to fill medically legitimate opioid prescriptions (Kollas CD, Boyer-Kollas B. Assessing Opioid Stigma in Oncology Outpatients Receiving Palliative Care for Cancer-Related Pain (S714). The Annual Assembly of the American Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association: Education Schedule and Abstracts. Journal of Pain and Symptom Management February 2018;55(2):663-4.) \u003Cbr\u003E\u003Cbr\u003EThe introduction of the NarxScore onto the query result page of the Florida PDMP beginning in September 2019 added yet another variable for physicians to consider when prescribing controlled medications. Almost half of the patients for whom NarxScores were available in our QI project fell into a category for which \u003Ca href=\"https:\/\/web.archive.org\/web\/20191118200847\/https:\/\/florida.pmpaware.net\/narx-content\/content\/narxcare2\/explain-overdose-risk-score.pdf\"\u003EApriss recommends consideration of co-prescribed naloxone to reduce the risk of harm from an opioid overdose \u003C\/a\u003E. None of the patients in our QI project experienced a need to use naloxone during the course of the project, but co-prescription of naloxone has gained support as a public safety measure to reduce opioid overdose deaths (AMA Task Force Reference). Our QI project does not allow an analysis of how the presence of the NarxScore itself might affect physician prescribing, but this would be an interesting area for future study. Based on our impressions of comments by fellow Florida physicians accessing E-FORSCE, we suspect that the NarxScore may introduce an additional “chilling effect” into the prescribing of controlled medications. Additionally, a very recent Florida law suggests that this chilling effect may be an intentional one. On June 25, 2019, Governor Ron DeSantis signed into law a requirement for Florida physicians to provide a written pamphlet entitled, “Information on Nonopioid Alternatives for the Treatment of Pain,” before prescribing any Schedule II analgesic to any patient (See \u003Ca href=\"https:\/\/web.archive.org\/save\/https:\/\/www.wlrn.org\/post\/gov-desantis-signs-new-florida-laws-street-racing-opioids-and-gardens\"\u003Ehere\u003C\/a\u003E and \u003Ca href=\"https:\/\/web.archive.org\/web\/20191118201211\/https:\/\/www.flsenate.gov\/Session\/Bill\/2019\/451\/BillText\/er\/PDF\"\u003Ehere\u003C\/a\u003E). Of note, the required pamphlet became available on June 28, 2019, just three days prior to the new law’s implementation date of July 1, 2019, and the sole version available as of this writing is written in English only. Moreover, this law also requires that prescribing physicians to inform patients explicitly that they have a right to refuse opioid analgesics, although patients have always possessed the right to refuse any unwanted treatments before implementation of the new law. \u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2018\/09\/mandated-queries-of-florida.html\"\u003EAfter our one-month assessment of this QI project\u003C\/a\u003E, we posed a question that we hoped we could answer after gathering three months’ worth of information from PDMP queries: Is physicians’ time best spent querying a database with a higher error rate than the rate at which it identifies medically inappropriate behavior and which might lead to worsening opioid stigma and difficulty filling prescriptions for cancer pain medications? Unfortunately, we remain unable to answer this question definitively, although our current results affirmed that the error rate of E-FORSCE exceeds the rate at which patients exhibit medically inappropriate behavior. More importantly, in light of Florida’s most recent law and PDMP changes, we were probably asking the wrong question. We should have been asking who would be held accountable for the inaccuracies in the E-FORSCE database. That answer came in mid-June 2019, when the E-FORSCE website added a qualifying statement to each patient’s query, which reads as follows: “The Department of Health makes no claims, promises, or guarantees the accuracy, completeness, or adequacy of the contents of the information in the E-FORCSE® database, and expressly disclaims liability for errors and omissions in the contents. The records herein are based on information submitted by pharmacies and dispensing health care practitioners. Records on this report should be verified before any clinical decisions are made or actions are taken” (Italics are mine). This statement effectively passes the risk from errors within the Florida PDMP back onto physicians, essentially forcing them to independently “verify” the information produced by the query. So not only do physicians have to spend much more time when prescribing opioid analgesics, they also assume the potential risks of interpreting the Florida PDMP data, which may be incorrect about 5% of the time. These policy changes occurred despite \u003Ca href=\"https:\/\/web.archive.org\/save\/https:\/\/www.asco.org\/advocacy-policy\/asco-in-action\/cdc-issues-key-clarification-guideline-prescribing-opioids-chronic\"\u003Eannouncements by the Centers for Disease Control\u003C\/a\u003E and \u003Ca href=\"https:\/\/www.medscape.com\/viewarticle\/911583\"\u003EFood and Drug Administration\u003C\/a\u003E that had begun to drive the pendulum of opioid policy back into a position of improved balance. While it remains unclear whether Florida physicians’ time is best spent querying a database, it seems clear that Florida’s politicians have doubled-down on a policy approach that bluntly endorses reductions in opioid prescribing, shifting risk for errors in the PDMP on the shoulders of Florida physicians and burdening physicians with mandated discussions that are clearly intended to discourage opioid prescribing, even in medically appropriate situations.  Our patients deserve better. \u003Cbr\u003E\u003Cbr\u003EDr. Kollas has provided outpatient palliative care at Orlando Health UFHealth Cancer Center for over 17 years. He first wrote about his personal experiences with chronic illness and pain in a 1997 article in the “On Being a Patient” series in Annals of Internal Medicine. You can \u003Ca href=\"http:\/\/twitter.com\/ChadDKollas\"\u003Efind him on Twitter at @ChadDKollas\u003C\/a\u003E. \u003C\/i\u003E\u003Cbr\u003E\u003Cbr\u003ETo cite this QI article: Kollas C. \u003Ci\u003EMandated Queries of the Florida Prescription Drug Monitoring Program:  A Three-Month Experience from a Cancer Center-Based Outpatient Palliative Medicine Clinic. \u003Ci\u003EPallimed\u003C\/i\u003E. November 2019. Available at: https:\/\/www.pallimed.org\/2019\/11\/mandated-queries-of-florida.html \u003Cbr\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"Mandated Queries of the Florida Prescription Drug Monitoring Program:  A Three-Month Experience from a Cancer Center-Based Outpatient Palliative Medicine Clinic\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"Dr. Chad Kollas shares the results from his three-month QI project on using PDMP data in an outpatient palliative care clinic.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/1.bp.blogspot.com\/-wdD41WyFIPc\/XdL4TF-Q14I\/AAAAAAACtl0\/eMn1NvSMDo8lyXint7d90RmPDSS3JiNyACLcBGAsYHQ\/s1600\/Mandated%2BQueries%2Bof%2Bthe%2BFlorida%2BPrescription%2BDrug%2BMonitoring%2BProgram_%2BEarly%2BExperiences%2Bfrom%2Ba%2BCancer%2BCenter-based%2BOutpatient%2BPalliative%2BMedicine%2BClinic.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2019\/11\/mandated-queries-of-florida.html\" \/\u003E"},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/8390492795192105894"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/8390492795192105894"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2019\/11\/mandated-queries-of-florida.html","title":"Mandated Queries of the Florida Prescription Drug Monitoring Program:  A Three-Month Experience from a Cancer Center-Based Outpatient Palliative Medicine Clinic"}],"author":[{"name":{"$t":"Pallimed Editor"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/11358791266969988517"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"16","height":"16","src":"https:\/\/img1.blogblog.com\/img\/b16-rounded.gif"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-wdD41WyFIPc\/XdL4TF-Q14I\/AAAAAAACtl0\/eMn1NvSMDo8lyXint7d90RmPDSS3JiNyACLcBGAsYHQ\/s72-c\/Mandated%2BQueries%2Bof%2Bthe%2BFlorida%2BPrescription%2BDrug%2BMonitoring%2BProgram_%2BEarly%2BExperiences%2Bfrom%2Ba%2BCancer%2BCenter-based%2BOutpatient%2BPalliative%2BMedicine%2BClinic.png","height":"72","width":"72"}},{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-1047866687745128147"},"published":{"$t":"2019-10-06T08:00:00.000-05:00"},"updated":{"$t":"2019-11-18T14:29:20.720-06:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"cancer"},{"scheme":"http://www.blogger.com/atom/ns#","term":"opioids"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"rosielle"},{"scheme":"http://www.blogger.com/atom/ns#","term":"The profession"}],"title":{"type":"text","$t":"Part 6 - Why Is Cancer Pain So Special?"},"content":{"type":"html","$t":"\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/4.bp.blogspot.com\/-wyohMlojgdI\/XZelYIsnKPI\/AAAAAAACocA\/2AX4FPpZawgg-vZQK4BgLy9XTdMf_nM6wCLcBGAsYHQ\/s1600\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25283%2529.png\" imageanchor=\"1\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg border=\"0\" src=\"https:\/\/4.bp.blogspot.com\/-wyohMlojgdI\/XZelYIsnKPI\/AAAAAAACocA\/2AX4FPpZawgg-vZQK4BgLy9XTdMf_nM6wCLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25283%2529.png\" width=\"320\" height=\"320\" data-original-width=\"800\" data-original-height=\"800\" \/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Drew Rosielle (\u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003E@drosielle\u003C\/a\u003E) \u003Cbr\u003E\u003Cbr\u003EA Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions. \u003Cbr\u003E\u003Cbr\u003EThis is the 5th post in a series about opioids, with a focus on how my thinking about opioids has changed over the years. See also:\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\"\u003EPart 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Grap\u003C\/a\u003Eh\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-5-why-do-we-lump-non-cancer-pain.html\"\u003EPart 5 – Why Do We Lump The Non-Cancer Pain Syndromes Together?\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003EThis is Part 6, which asks the sort of inverse question to \u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-5-why-do-we-lump-non-cancer-pain.html\"\u003EPart 5\u003C\/a\u003E – Why Is Cancer Pain So Special? \u003Cbr\u003E\u003Cbr\u003EWhy is cancer pain, in so many guidelines and organizational\/public policies ‘exempted’ from the dosing and safety guidelines. This is not a rhetorical question – I have not actually ever read a coherent explanation as to why. \u003Cbr\u003E\u003Cbr\u003EOne might reasonably assume there’s all this research demonstrating the safety and efficacy of long-term opioid use in cancer patients. In reality, that research is non-existent. \u003Cbr\u003E\u003Cbr\u003EGuidelines like the CDC’s accurately point out that there are essentially no data demonstrating the long term efficacy of opioids for ‘chronic non-cancer pain’ (CNCP). True enough.   \u003Cbr\u003E\u003Cbr\u003EBut where is the study proving the long-term safety and efficacy of opioids for cancer pain?  Where are the well-designed, controlled (or at the very least prospectively designed and closely monitored) studies of opioids for cancer pain which follows patients for longer than 6 months? It’s possible I’ve missed some key studies, but don’t think I have (but correct me in the comments if I have!). \u003Cbr\u003E\u003Cbr\u003ENotably, there are a collection of studies like \u003Ca href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19814586\"\u003Ethis one\u003C\/a\u003E, all involving 6 months or longer of open-label monitoring after a RCT of an opioid for cancer pain. It’s middling quality data involving highly selected patients, and, importantly, for every study like this in the cancer world there’s a similar one \u003Ca href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20370845\"\u003Elike this one in involving CNCP patients\u003C\/a\u003E. In other words, I don’t see that we are in a situation where we can say we have more convincing, higher quality data for cancer patients than non-cancer patients overall.  \u003Cbr\u003E\u003Cbr\u003EAnd, what exactly do we mean by ‘cancer pain?’ A patient with metastatic breast cancer to bone who has bone pain? I think most of us would consider their pain ‘cancer pain’? What about someone with severely painful multiple myeloma who achieves a long-term remission but their bone pain only partially resolves? Their X-rays and scans continue to show widespread lytic bone lesions, but they don’t have active myeloma. And they may go 5-10 years before relapse. Is that cancer pain? \u003Cbr\u003E\u003Cbr\u003EWhat about someone with severe, non-healing, osteoradionecrosis of the jaw but no evidence of active oral cancer anymore? Let me tell you, that patient will have severe pain, potentially for life. What about the patient with breast cancer – does it matter she may live over 5 years even with widespread, painful bone metastases? Is that still ‘cancer pain’ (obviously it is), but if so why do we collectively seem to make an important difference between her and the patient who may also live many years with painful, nonhealing osteoradionecrosis? None of this is to mention chemotherapy induced peripheral neuropathies – are those cancer pain? I’m not proposing that I know the answer to these questions – what I’m trying to do however is to make clear that I don’t think we are operating with a set of really fuzzy, imprecise, and ill-defined concepts even when we say something like ‘cancer pain.’  \u003Cbr\u003E\u003Cbr\u003ESo, I think about all this a lot, and here’s where my current thinking is. \u003Cbr\u003E\u003Cbr\u003EFirst off, I’ve been trying to find the answer to the question why is cancer pain treated so much differently in these guidelines? Like I intimated above, I don’t actually believe it’s due to there being significantly more\/better research data out there establishing the safety and efficacy of opioids for cancer pain than the CNCP syndromes. As I’ve been writing this, I did some rooting around to try to see if I was wrong, and didn’t find anything to change my mind about this. If you want to, \u003Ca href=\"https:\/\/www.cochrane.org\/search\/site\/opioids%20pain\"\u003Edig through this list of Cochrane reviews on the subject\u003C\/a\u003E, and then try to convince yourself that, in important ways, we have better data for cancer than non-cancer pain syndromes. \u003Cbr\u003E\u003Cbr\u003EIs it because we believe cancer generally hurts more than other pain syndromes? I hope not, that is stupid and wrong. \u003Cbr\u003E\u003Cbr\u003EIs it because we believe patients with cancer are more morally deserving of pain relief than others? Christ, I hope not. \u003Cbr\u003E\u003Cbr\u003EIs it history? That cancer pain has a deep history of decades of advocacy internationally to normalize chronic opioid use for it which has been successful? Maybe, but opioids for CNCP advocacy also has a pretty deep history of advocacy too, and I don’t think this is enough to explain the difference.  \u003Cbr\u003E\u003Cbr\u003EIs it because there is something unique about the cause of pain in cancer that makes it reasonably more likely to respond well to opioids long-term than other syndromes? While acknowledging this remains speculative for all of us, I do think this idea at least has some basis in reality, but it only goes so far, and does not justify broad lumping of all the CNCP syndromes together, or all pain-from-cancer syndromes together. That is to say, for at least some of the cancer pain syndromes we encounter, patients, in pretty straight-forward way, have space forming, inflammatory, and infiltrative tumors causing the pain. Ie, the cause of the pain is from clinically obvious, direct, inflammation-heavy, tissue damage and destruction, and, arguably, pain from this etiology (let me call it ‘tissue damage pain’ for short here) responds better long-term to opioids than pain from other causes. \u003Cbr\u003E\u003Cbr\u003EWhile I don’t think I can cite you clear research data to prove this, I myself basically believe this\/accept it to be true:  tissue damage pain responds pretty well to opioids, long-term. Obviously, for many CNCP syndromes there is not this ‘tissue damage’ etiology. However, there are many syndromes, ones I’d note that you see a lot if you care for people with serious illness, that do involve tissue damage – sickle cell disease, some types of chronic wound pain, some types of osteonecrosis, ischemic limb pain, possibly pain from some of the inflammatory arthritidies, etc. (Referring to ‘cancer pain’ scenarios I mentioned above, I don’t myself know how to really categorize the chronic bone pain in patients who have achieved remission for multiple myeloma. Is that ‘tissue damage pain’ as I’ve defined it? I’m not sure.) \u003Cbr\u003E\u003Cbr\u003ESo, if this is the reason we treat cancer pain as special, my basic request to the world is that we actually say what we mean, and replace cancer pain with something like ‘pain from active tissue damage.’ It’s a godawful mouthful I know, undoubtedly there’s a more euphonious term one can use, but hopefully you get my point. Maybe we should coin a new term: “inflammalgia?” \u003Cbr\u003E\u003Cbr\u003EFinally, is cancer pain treated special because patients with cancer are assumed to be terminally ill? At the end of the day, I think this is actually the predominant reason cancer pain is exempted from all these guidelines. It’s the same reason ‘palliative care’ patients are exempted – it’s because the people who write these guidelines think we’re only caring for patients near the end of life. \u003Cbr\u003E\u003Cbr\u003ETo an extent, I do think the poor prognosis-basis for the difference has some merit. If someone has a short prognosis (I’m not going to define what that means but I know it when I see it), I think it’s a pretty uncontroversial statement that having a short prognosis markedly changes the benefit:risk ratio when it comes to opioids.  While preservation of function is typically a goal until a patient is really in the final stages of life, for patients with terminal illness and severe pain the simple goal of aggressively relieving suffering is often paramount, and opioids do a really good job of that, especially in the short term. Additionally, the risks to a patient of a lot of the long-term pernicious effects of opioids are less if time is short. \u003Cbr\u003E\u003Cbr\u003EMakes sense to me, but I worry about an unexpected effect of exempting cancer pain from these guidelines and discussions: it gives some people the sense that opioids are unquestionably indicated for patients with cancer and we don’t really have to worry about pain. I’ve seen many situations in which a patient clearly has a dangerous OUD, who has pain and cancer, and people just keep on prescribing. Or, worse, a patient is clearly diverting and people just keep prescribing because 'they have cancer and we have to treat the pain, right?' You encounter the attitude also of 'well they’re dying so who really cares', which makes me want to vomit, as if addiction is a pleasurable thing for people and a great time for a family and not anything other than a \u003Ci\u003Etremendous source of total suffering\u003C\/i\u003E, although I’m happy to say that lately it’s mostly been patients saying that to me (\"I have cancer you have to give me meds. Who cares I’m dying anyway\"), not my colleagues. \u003Cbr\u003E\u003Cbr\u003EFundamentally, I’m not really arguing that the policies or guidelines should be rewritten to lump cancer pain and CNCP together. Selfishly, we already waste a ton of time in my clinic begging to get opioids covered for my patients as it is, even for dying cancer patients, and I don’t want anything to happen to make that harder. Mostly I’m arguing the great split between cancer and noncancer pain is harmful because it encourages fuzzy thinking about risk in cancer patients, and lumps too many unrelated non-cancer pain syndromes together, in ways that are really harmful for people, and encourages clinicians and policy makers to think about, eg, a 60 year old patient with severe degenerative arthritis who can’t get out of bed due to pain with a 60 year old patient with depression, anxiety, a history of alcohol use disorder, and ill-defined chronic abdominal pain and headaches in the same category. \u003Cbr\u003E\u003Cbr\u003EIt encourages us to simplify what is complex, and our patients deserve better. \u003Cbr\u003E\u003Cbr\u003EThanks for listening,\u003Cbr\u003E--Drew.  \u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\"\u003EPart 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-5-why-do-we-lump-non-cancer-pain.html\"\u003EPart 5 – Why Do We Lump The Non-Cancer Pain Syndromes Together?\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-6-why-is-cancer-pain-so-special.html\"\u003EPart 6 - Why Is Cancer Pain So Special?\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/opioids\"\u003EPallimed posts about opioids.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/rosielle\"\u003EPallimed posts by Dr. Rosielle click here.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ci\u003EDrew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on \u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003ETwitter at @drosielle\u003C\/a\u003E. \u003C\/i\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"Part 6 - Why Is Cancer Pain So Special?\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"A Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/4.bp.blogspot.com\/-wyohMlojgdI\/XZelYIsnKPI\/AAAAAAACocA\/2AX4FPpZawgg-vZQK4BgLy9XTdMf_nM6wCLcBGAsYHQ\/s1600\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25283%2529.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2019\/10\/part-6-why-is-cancer-pain-so-special.html\" \/\u003E"},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/1047866687745128147"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/1047866687745128147"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2019\/10\/part-6-why-is-cancer-pain-so-special.html","title":"Part 6 - Why Is Cancer Pain So Special?"}],"author":[{"name":{"$t":"Drew Rosielle MD"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/04345646798042773615"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"32","height":"32","src":"\/\/3.bp.blogspot.com\/-sdxTTBPb3Kw\/UddApiGn9-I\/AAAAAAAABLE\/mriu5xh44dA\/s113\/ea37b7645cd78e7867d246cd755bc8d4.jpeg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-wyohMlojgdI\/XZelYIsnKPI\/AAAAAAACocA\/2AX4FPpZawgg-vZQK4BgLy9XTdMf_nM6wCLcBGAsYHQ\/s72-c\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25283%2529.png","height":"72","width":"72"}},{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-2314517349689698382"},"published":{"$t":"2019-10-06T07:00:00.000-05:00"},"updated":{"$t":"2019-11-18T14:30:51.616-06:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"opioid"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"rosielle"},{"scheme":"http://www.blogger.com/atom/ns#","term":"The profession"}],"title":{"type":"text","$t":"Part 5 - Why Do We Lump the Non-Cancer Pain Syndromes Together?"},"content":{"type":"html","$t":"\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/3.bp.blogspot.com\/-JClvZZFxspU\/XZejTiPUQJI\/AAAAAAACob0\/6zkATSJDcWkfktfPpeZrQdJxrj7Ys3VBgCLcBGAsYHQ\/s1600\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25282%2529.png\" imageanchor=\"1\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg border=\"0\" data-original-height=\"800\" data-original-width=\"800\" height=\"320\" src=\"https:\/\/3.bp.blogspot.com\/-JClvZZFxspU\/XZejTiPUQJI\/AAAAAAACob0\/6zkATSJDcWkfktfPpeZrQdJxrj7Ys3VBgCLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25282%2529.png\" width=\"320\" \/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Drew Rosielle (\u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003E@drosielle\u003C\/a\u003E) \u003Cbr \/\u003E\u003Cbr \/\u003EA Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions. \u003Cbr \/\u003E\u003Cbr \/\u003EThis is the 5th post in a series about opioids, with a focus on how my thinking about opioids has changed over the years. See also:\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\"\u003EPart 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003EThis is Part 5 – Why Do We Lump The Non-Cancer Pain Syndromes Together? \u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-6-why-is-cancer-pain-so-special.html\"\u003EPart 6\u003C\/a\u003E is heavily related to Part 5, and will ask the sort of inverse to Part 5 – \u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-6-why-is-cancer-pain-so-special.html\"\u003EWhy Is Cancer Pain So Special?\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003EThe language we use to categorize pain and talk about pain is inadequate, dangerous, and unfair. \u003Cbr \/\u003E\u003Cbr \/\u003EIn particular what I mean here are the distinctions made between ‘chronic pain’ and ‘cancer pain.’ \u003Cbr \/\u003E\u003Cbr \/\u003EWhat is actually meant by chronic pain? In the very important CDC opioid guidelines, they use this definition:  “Chronic pain has been variably defined but is defined within this guideline as pain that typically lasts at least 3 months or past the time of normal tissue healing.” Most definitions use something like that. Note that the definition really focuses on the temporality of the pain, which is of course important, but really makes no proposal otherwise on what the pain syndrome is, what its course is, what causes it, what the patient’s prognosis is, whether or not it involves a primary ongoing lesion of the nervous system or ongoing active tissue inflammation and damage (eg, chronic rheumatoid arthritis pain, chronic sickle cell pain, etc, which can continue for years), etc. \u003Cbr \/\u003E\u003Cbr \/\u003EWhat this leads to is a broad lumping together of dozens of different pain syndromes into a single category: ‘chronic pain,’ or ‘chronic non-cancer pain’ (I’ll just say CNCP here for brevity).  \u003Cbr \/\u003E\u003Cbr \/\u003EReading guidelines like the CDC’s, they basically apply themselves to all CNCP, with a brief, unexplained exception for patients with cancer pain, or who are receiving palliative care, whatthehellever that means. \u003Cbr \/\u003E\u003Cbr \/\u003EWhich essentially means in those guidelines, and in all the policy responses to them (by payors, state medical and pharmacy boards, local health organizations implementing new policies, etc), all CNCP syndromes are lumped together. \u003Cbr \/\u003E\u003Cbr \/\u003EThink about this. From a policy standpoint it treats chronic pain from fibromyalgia, work-related back injuries, chronic headaches, severe inflammatory arthritidies, poorly defined chronic abdominal and pelvic pain syndromes, moderate degenerative arthritis, bone on bone deforming degenerative arthritis, sickle cell disease, congenital spine deformities like severe scoliosis, spasticity syndromes like multiple sclerosis or cerebral palsy, chronic bone diseases like osteonecrosis, chronic ischemic limb pain, chronic wound pain, post-surgical neuralgias, complex regional pain syndrome, the dozens of types of axonal neuropathies, etc.,\u003Ci\u003E as the same thing\u003C\/i\u003E (from a policy standpoint). \u003Cbr \/\u003E\u003Cbr \/\u003EYou get my point, I hope, which is to argue that many of these are very different pain syndromes, which have different prognoses and ranges\/types of treatments, and regardless of anything else, should not be lumped together without qualification with the couple syndromes that we do in fact have half-way decent-ish research data showing that opioids aren’t effective (for most patients), (long-term), (eg, chronic back pain, fibromyalgia, chronic headache syndromes). This is not me arguing that opioids are the best or first-line analgesic for many of the other pain syndromes (!), but more to point out that highly influential guidelines or organizational\/public policies which do not differentiate between, say, the patient lacking cartilage in most of their weight-bearing large joints who has trouble taking the dog out to pee without a few hydrocodone a day (who’s tried many other modalities also), and the depressed, unemployed patient with a work-related back injury who drinks to intoxication most days a week and is on long-term opioid therapy (which has not been successful to restore function), is a shit guideline\/policy. \u003Cbr \/\u003E\u003Cbr \/\u003EI can’t see a clinically coherent or fair reason to do this lumping, except that these things aren’t ‘cancer pain’ (see the next post on this).  Like everything, it’s complex, and what we need are thoughtful, skilled clinicians who are knowledgeable and who can perform individualized assessments and treatment planning with patients, not one-size-fits-all lumping, but these policies and guidelines discourage that, regardless of their authors stated intentions (I don’t care what their intentions were), and that’s crap.  \u003Cbr \/\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\"\u003EPart 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/opioids\"\u003EPallimed posts about opioids.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/rosielle\"\u003EPallimed posts by Dr. Rosielle click here.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ci\u003EDrew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on \u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003ETwitter at @drosielle\u003C\/a\u003E. \u003C\/i\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"Part 5 - Why Do We Lump the Non-Cancer Pain Syndromes Together?\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"A Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/3.bp.blogspot.com\/-JClvZZFxspU\/XZejTiPUQJI\/AAAAAAACob0\/6zkATSJDcWkfktfPpeZrQdJxrj7Ys3VBgCLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25282%2529.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2019\/10\/part-5-why-do-we-lump-non-cancer-pain.html\" \/\u003E"},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/2314517349689698382"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/2314517349689698382"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2019\/10\/part-5-why-do-we-lump-non-cancer-pain.html","title":"Part 5 - Why Do We Lump the Non-Cancer Pain Syndromes Together?"}],"author":[{"name":{"$t":"Drew Rosielle MD"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/04345646798042773615"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"32","height":"32","src":"\/\/3.bp.blogspot.com\/-sdxTTBPb3Kw\/UddApiGn9-I\/AAAAAAAABLE\/mriu5xh44dA\/s113\/ea37b7645cd78e7867d246cd755bc8d4.jpeg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/3.bp.blogspot.com\/-JClvZZFxspU\/XZejTiPUQJI\/AAAAAAACob0\/6zkATSJDcWkfktfPpeZrQdJxrj7Ys3VBgCLcBGAsYHQ\/s72-c\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25282%2529.png","height":"72","width":"72"}},{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-1105875244575329532"},"published":{"$t":"2019-10-05T07:00:00.000-05:00"},"updated":{"$t":"2019-10-05T07:00:01.547-05:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"opioids"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"rosielle"},{"scheme":"http://www.blogger.com/atom/ns#","term":"The profession"}],"title":{"type":"text","$t":"Part 4 - Everything We Were Taught About High Doses Was Wrong, and the Same Hand-Crafted Graph"},"content":{"type":"html","$t":"\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/2.bp.blogspot.com\/-wLzRoVPOa50\/XZec1n1506I\/AAAAAAACobk\/OS1sTKXcWJQbVnzykoktasvMxH3XHyRlACLcBGAsYHQ\/s1600\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25281%2529.png\" imageanchor=\"1\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg border=\"0\" src=\"https:\/\/2.bp.blogspot.com\/-wLzRoVPOa50\/XZec1n1506I\/AAAAAAACobk\/OS1sTKXcWJQbVnzykoktasvMxH3XHyRlACLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25281%2529.png\" width=\"320\" height=\"320\" data-original-width=\"800\" data-original-height=\"800\" \/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Drew Rosielle (\u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003E@drosielle\u003C\/a\u003E) \u003Cbr\u003E\u003Cbr\u003E\u003Ci\u003EA Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions. \u003Cbr\u003E\u003Cbr\u003EThis is the 4th post in a series about opioids, with a focus on how my thinking about opioids has changed over the years. See also:\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003C\/i\u003E\u003Cbr\u003E\u003Cbr\u003EThis is Part 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph \u003Cbr\u003E\u003Cbr\u003EI no longer consider opioid dosing and conversions as a linear matter. That is, my approach to both opioid dose adjustments and rotations changes markedly the higher the dose of opioid a patient is on. \u003Cbr\u003E\u003Cbr\u003EMost of us have long been familiar with the idea that methadone’s ‘equianalgesic’ relationship to other opioids is non-linear. Ie, the higher the dose of another opioid you’re on, methadone becomes relatively more potent (you use relatively less methadone) – the equianalgesic ratio changes. \u003Cbr\u003E\u003Cbr\u003EI now believe this is true of all opioids both with conversions and with titrations, and I imagine a lot of you believe this too. \u003Cbr\u003E\u003Cbr\u003ETo give you an example:  if someone is on 4 mg of oral hydromorphone PRN and has severe uncontrolled pain, there’s a decent chance I’d increase them to 8 mg if they’re otherwise doing ok, and if I did I wouldn’t spend much time worrying about that decision. If someone is on 40 mg of oral hydromorphone PRN – while what I would end up doing is a highly individualized decision, let me tell you I would 100% think twice before increasing them to 80 mg. In fact, I’d be extraordinarily unlikely to do that, whereas I just wouldn’t hesitate to double a similar patient from 4 to 8 mg. Ie, despite all the textbooks saying we should increase opioids in percentile increments I don’t believe that once I’m working with high doses. It Is Not Linear. \u003Cbr\u003E\u003Cbr\u003EAnd I bet a lot a lot of you reading this would agree – you’d, at least, hesitate. And I’ve been asking myself why, and again I think part of it is my recognition that very high doses are rarely effective, or at the very least changes at the very high range of opioid dosing are far less effective than in the low range (see my last post and its lovely hand-made graphic which I’m reproducing here), and that the benefit:hazard ratio of escalating at very high doses is far lower than with low dose opioids. (About that benefit: hazard ratio – for well monitored, highly opioid tolerant patients I’m not arguing that the risk of harmful overdose is very high for these patients, in my experience it isn’t and opioid tolerance is a truly remarkable thing. I’m more arguing that the benefit to patients from dose escalations for patients already in the very high range are very small, and much smaller for the typical patient when you, say, increase their morphine ER from 15 mg to 30 mg). \u003Cbr\u003E\u003Cbr\u003E\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/1.bp.blogspot.com\/--Hm_7oaGuLc\/XYESFhVobzI\/AAAAAAAACRA\/4Vz9OoGhk4s96kikVEO45l9ZMCKHqyrCgCEwYBhgL\/s640\/high%2Bdose%2Bopioid%2Bcurve.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"\u003E\u003Cimg border=\"0\" src=\"https:\/\/1.bp.blogspot.com\/--Hm_7oaGuLc\/XYESFhVobzI\/AAAAAAAACRA\/4Vz9OoGhk4s96kikVEO45l9ZMCKHqyrCgCEwYBhgL\/s320\/high%2Bdose%2Bopioid%2Bcurve.png\" width=\"320\" height=\"231\" data-original-width=\"640\" data-original-height=\"462\" \/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003Cbr\u003E\u003Cbr\u003ERegardless of the reasons underlying it, my point here is that I do, and I think most people do, think of these ratios, and these rules of dose titration, differently at high doses than at lower\/moderate doses, although I’ve never yet read that anywhere, and I don’t really understand why because my impression is that this is common practice. \u003Cbr\u003E\u003Cbr\u003ESame with drug rotation. \u003Cbr\u003E\u003Cbr\u003EThere’s been a lot of speculation with methadone – why it seems to be more potent the higher the baseline opioid someone is on and some of the speculation is that patients are hyperalgesic from the baseline opioid, and since methadone perhaps directly counteracts some of that hyperalgesia or at the very least doesn’t contribute to it much, it can be surprisingly potent. Eg, we can get away with such small doses of methadone sometimes because a patient’s baseline opioid dose was largely there just to overcome the hyperalgesia from that very baseline opioid. If that’s the case, then you could also imagine a scenario where the same phenomenon would obtain, at least to an extent, with rotating away from any opioid at a very high dose, not just methadone. To an extent: other commonly used opioids don’t theoretically counteract tolerance and hyperalgesia in the way we believe methadone does, but nonetheless it’s a sort of ‘partial-cross tolerance’ phenomenon. Ie, going from, say, high dose hydromorphone to morphine, perhaps you don’t have as much hyperalgesia initially from that morphine so you can get away with lower relative morphine dose. I need to stress this is speculation, I do not understand the mechanism here, but am more observing that the speculative explanation we have about why it seems to work for methadone could partially apply to any opioid rotation. \u003Cbr\u003E\u003Cbr\u003EI don’t think any of this is extraordinary, however I’ll also add that I haven’t really seen any of this in a textbook, or as an asterix in opioid conversion tables (with the exception of methadone). \u003Cbr\u003E\u003Cbr\u003EConsider this example: I remember every pretty early on in my career, having people on something like 10 mg\/hr continuous hydromorphone infusions and needing to transition them off the IVs and doing the math and feeling the acid and bile rise to the back of my mouth. Eg 10 mg\/hr = 240 mg\/24 h = 4800 mg OME (by most equianalgesic tables). Even if you reduced ‘for incomplete cross tolerance’ by a whopping 75% (which, I’ll note, is more than most textbooks ever mention) that would still be putting someone on, eg, MSContin 600 mg twice a day. Like, whoa. Like, would any of you do that? Even if you use the so-called ‘new’ ratios based off the \u003Ca href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28711751\"\u003Eexcellent MD Anderson study looking at IV hydromorphone to PO med ratios\u003C\/a\u003E, that suggests a ratio of 1 mg hydromorphone : 10 mg PO morphine, which would be 2400 mg of morphine a day. And, note, that study calculated the ratio based on the final dose of what the patient actually ended up on, so if we use this as a conversion ratio the implication is you don’t need to account further for incomplete cross tolerance, which would suggest in fact we put this patient on 1200 mg of morphine ER bid. \u003Cbr\u003E\u003Cbr\u003ELOL\/puke. \u003Cbr\u003E\u003Cbr\u003E(Now that I prescribe methadone…we didn’t prescribe it much where I started my career…I just put them on something like 10 mg tid of methadone and continue to be delighted that *most* of the time it goes just fine.) \u003Cbr\u003E\u003Cbr\u003EBut here’s the point: even before I routinely used methadone in these situations, I still ended up putting people on far lower doses than any textbook\/consensus guidelines would recommend, maybe something like 120 mg tid of morphine ER and was surprised at how it went ok much of the time. Patients were ok (not perfect, adjustments were needed, but the rotation was not a catastrophe) with what is technically a massive dose reduction. \u003Cbr\u003E\u003Cbr\u003EWhy can we ‘get away’ with stuff like this? We can speculate all we want why but we don’t know, but I’m still going to make an empirical claim that the so-called equianalgesic ratios don’t apply at high doses. \u003Cbr\u003E\u003Cbr\u003EThey are worse than worthless, they are dangerous. \u003Cbr\u003E\u003Cbr\u003EWhen I talk with people around the country about this, most people I talk with are doing just what I describe above. So, I don’t think I’m describing a particularly novel or extraordinary clinical approach. \u003Cbr\u003E\u003Cbr\u003EWhat I’m more interested in is why we still talk about methadone’s non-linear conversion curve as something unique, when it isn’t (methadone’s curve is probably more pronounced than with other opioids, but the fact that it has a curve is not). By acting like methadone’s all fancy and unique, and by putting out equianalgesic charts and dose adjustment rules (eg the 25-50-100% rule) that don’t qualify that perhaps none of this applies to patients on very high doses, I think we are promoting unsafe practices. To an extent, most patients on very high doses are being cared for by specialists, and most of us know what we’re doing, so we have that safety buffer, but that doesn’t seem like enough \u003Cbr\u003E\u003Cbr\u003EMost fellowship years, a few months into it, a fellow comes to me as they are figuring this out, and I have to break the news to them that most of us throw those tables out for patients on very high doses, and it’s kind of like breaking bad news to them, and I start telling them the truth, is that I sometimes don’t even bother doing the math when people are on really high doses, and half the time just ask myself Is there any reason not to put this patient on 10 mg of methadone tid? and nothing else. \u003Cbr\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\"\u003EPart 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph\u003C\/a\u003E\u003Cbr\u003EPart 5 – Why Do We Lump The Non-Cancer Pain Syndromes Together?\u003Cbr\u003EPart 6 - Why Is Cancer Pain So Special?\u003Cbr\u003E\u003Cbr\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/opioids\"\u003EPallimed posts about opioids.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/rosielle\"\u003EPallimed posts by Dr. Rosielle click here.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ci\u003EDrew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on \u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003ETwitter at @drosielle\u003C\/a\u003E. \u003C\/i\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"Part 4 – Everything We Were Taught About High Doses Was Wrong, And The Same Hand-Crafted Graph.\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"A Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/2.bp.blogspot.com\/-wLzRoVPOa50\/XZec1n1506I\/AAAAAAACobk\/OS1sTKXcWJQbVnzykoktasvMxH3XHyRlACLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25281%2529.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html\" \/\u003E"},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/1105875244575329532"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/1105875244575329532"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2019\/10\/part-4-everything-we-were-taught-about.html","title":"Part 4 - Everything We Were Taught About High Doses Was Wrong, and the Same Hand-Crafted Graph"}],"author":[{"name":{"$t":"Drew Rosielle MD"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/04345646798042773615"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"32","height":"32","src":"\/\/3.bp.blogspot.com\/-sdxTTBPb3Kw\/UddApiGn9-I\/AAAAAAAABLE\/mriu5xh44dA\/s113\/ea37b7645cd78e7867d246cd755bc8d4.jpeg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-wLzRoVPOa50\/XZec1n1506I\/AAAAAAACobk\/OS1sTKXcWJQbVnzykoktasvMxH3XHyRlACLcBGAsYHQ\/s72-c\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup%2B%25281%2529.png","height":"72","width":"72"}},{"id":{"$t":"tag:blogger.com,1999:blog-13495125.post-2199068077687446324"},"published":{"$t":"2019-10-04T15:40:00.000-05:00"},"updated":{"$t":"2019-10-04T15:44:04.508-05:00"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"opioids"},{"scheme":"http://www.blogger.com/atom/ns#","term":"pain"},{"scheme":"http://www.blogger.com/atom/ns#","term":"rosielle"},{"scheme":"http://www.blogger.com/atom/ns#","term":"The profession"}],"title":{"type":"text","$t":"Part 3 - Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph"},"content":{"type":"html","$t":"\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/2.bp.blogspot.com\/-ub7tgAwh2ys\/XZeXWTgy8eI\/AAAAAAACobA\/wW6YZB569DAXE9sLUToXfuj59ZhT3CM9wCLcBGAsYHQ\/s1600\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup.png\" imageanchor=\"1\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg border=\"0\" data-original-height=\"800\" data-original-width=\"800\" height=\"320\" src=\"https:\/\/2.bp.blogspot.com\/-ub7tgAwh2ys\/XZeXWTgy8eI\/AAAAAAACobA\/wW6YZB569DAXE9sLUToXfuj59ZhT3CM9wCLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup.png\" width=\"320\" \/\u003E\u003C\/a\u003E\u003C\/div\u003Eby Drew Rosielle (\u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003E@drosielle\u003C\/a\u003E) \u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ci\u003EA Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions. \u003Cbr \/\u003E\u003Cbr \/\u003EThis is the 3rd post in a series about opioid, with a focus on how my thinking about opioids has changed over the years. See also:\u003Cbr \/\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003C\/i\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Chr\u003E\u003Cbr\u003E\u003Cbr\u003EThis is Part 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph \u003Cbr \/\u003E\u003Cbr \/\u003EI believed, and was taught, opioids had no intrinsic ceiling effect, and didn't think there was much difference between someone being on 100 mg of morphine a day or 1000 mg. I wish this was the case, but the number of patients I can recall the last 20 years who were on very high opioid doses who were doing 'great' (had excellent pain relief leading to important functional improvements and minimal side effects) is minimal (but not zero, mind you). Like, less than 5% of patients I’ve placed on very high doses. (I’ll be the first to admit I don’t have an exact definition of what that is, I don’t think that’s possible, but generally I’m talking about many hundreds of morphine milligram equivalents a day.) Most patients remained in terrible pain and had significant, ongoing disability despite the high doses (and undoubtedly for some of them because of the high doses). I’d increase someone’s dose, they’d report they’d feel better, but within a few weeks or months they’d continue to report daily, severe pain, and function would not have improved. I saw this pattern again and again. They weren’t overdosing, most of them were fine from a safety standpoint, they just weren’t helped by me pushing their doses into the very high range. As I look back on this, it’s bizarre to me I didn’t see more clearly in the past just how poorly most of my patients on high doses were doing. How I ignored that little voice inside of me which said, \u003Ci\u003E“Drew, they’re already on many hundreds of milligrams a day, they continue to report daily, severe pain…opioids are not helping them anymore.” \u003C\/i\u003E\u003Cbr \/\u003E\u003Cbr \/\u003ESo much so that I’ve mostly stopped prescribing opioids, long-term, in those ranges, outside of patients who are dying and the care goals are really centered around alleviating suffering in those final days\/weeks. (I use those doses short term during hospitalizations for pain crises.) \u003Cbr \/\u003E\u003Cbr \/\u003EI should note here that I don’t think it’s helpful to calculate ‘morphine equivalents’ for someone on methadone for pain. I know people do it, but I don’t, and I personally think it’s a folly, it’s too much comparing apples and oranges, and the fact we know how to convert someone from methadone to a ‘typical’ opioid without killing them is a different thing than being able to speak confidently along the lines of “40 mg a day of oral methadone is equivalent to X mg a day of oral morphine.” Like, does anyone think they’ve got a good grip on that (if you do, please comment)?  That’s not a question I’ve asked myself for years now because I don’t think it has an answer, and I think it’s a different question than “what is a safe and reasonable dose of oral morphine to convert someone to a day who is on 40 mg of methadone daily.” Part of this is because I think a lot of what’s pernicious about commonly used non-methadone opioids really comes out at higher doses (see my next post in this series), and I think those pernicious phenomena are really muted for methadone, and as I think about patients I have different categories in my head for patients on, saying, hundreds of milligrams of morphine a day who’s doing poorly (not getting good pain relief), and someone who’s on quite a high dose of methadone who’s not getting good pain relief. To me, those are different situations, whereas there’s not much of a difference in my brain’s way of categorizing the world between someone doing poorly on very high dose morphine and oxycodone, for instance. \u003Cbr \/\u003E\u003Cbr \/\u003E\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\u003Ca href=\"https:\/\/1.bp.blogspot.com\/-jkJu29WfUO8\/XZeZlhcH4PI\/AAAAAAACobM\/hnyrK2J6ZCk_bcbK9sU0A61SqeyY8yZCwCLcBGAsYHQ\/s1600\/opioid%2Bgraph%2B2.PNG\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"\u003E\u003Cimg border=\"0\" data-original-height=\"470\" data-original-width=\"664\" height=\"227\" src=\"https:\/\/1.bp.blogspot.com\/-jkJu29WfUO8\/XZeZlhcH4PI\/AAAAAAACobM\/hnyrK2J6ZCk_bcbK9sU0A61SqeyY8yZCwCLcBGAsYHQ\/s320\/opioid%2Bgraph%2B2.PNG\" width=\"320\" \/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003Cbr \/\u003E\u003Cbr \/\u003ESo, I believe patients absolutely have a therapeutic ceiling effect with opioids, and at doses that are lower than I realized years ago, although everyone’s ceiling is different, but that should not be much of a surprise.  \u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/a-series-of-observations-on-opioids-by.html\"\u003EPart 1 – Introduction, General Disclaimers, Hand-Wringing, and a Hand-Crafted Graph.\u003C\/a\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-2-we-were-wrong-20-years-ago-our.html\"\u003EPart 2 – We Were Wrong 20 years Ago, Our Current Response to the Opioid Crisis is Wrong, But We Should Still Be Helping Most of our Long-Term Patients Reduce Their Opioid Doses\u003C\/a\u003E\u003Cbr \/\u003E\u003Ca href=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\"\u003EPart 3 – Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/opioids\"\u003EPallimed posts about opioids.\u003C\/a\u003E\u003Cbr \/\u003EFor more \u003Ca href=\"https:\/\/www.pallimed.org\/search\/label\/rosielle\"\u003EPallimed posts by Dr. Rosielle click here.\u003C\/a\u003E\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Ci\u003EDrew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on \u003Ca href=\"https:\/\/twitter.com\/drosielle\"\u003ETwitter at @drosielle\u003C\/a\u003E. \u003C\/i\u003E\u003Cmeta name=\"twitter:card\" content=\"summary\" \/\u003E\u003Cmeta name=\"twitter:site\" content=\"@pallimed\" \/\u003E\u003Cmeta name=\"twitter:title\" content=\"Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph\" \/\u003E\u003Cmeta name=\"twitter:description\" content=\"Part 3 - A Series of Observations on Opioids By a Palliative Doc Who Prescribes A Lot of Opioids But Also Has Questions.\" \/\u003E\u003Cmeta name=\"twitter:image\" content=\"https:\/\/2.bp.blogspot.com\/-ub7tgAwh2ys\/XZeXWTgy8eI\/AAAAAAACobA\/wW6YZB569DAXE9sLUToXfuj59ZhT3CM9wCLcBGAsYHQ\/s320\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup.png\" \/\u003E\u003Cmeta name=\"twitter:url\" content=\"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html\" \/\u003E   "},"link":[{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/2199068077687446324"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/13495125\/posts\/default\/2199068077687446324"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pallimed.org\/2019\/10\/part-3-opioids-have-ceiling-effects.html","title":"Part 3 - Opioids Have Ceiling Effects, High-Doses are Rarely Therapeutic, and Another Hand-Crafted Graph"}],"author":[{"name":{"$t":"Drew Rosielle MD"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/04345646798042773615"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"32","height":"32","src":"\/\/3.bp.blogspot.com\/-sdxTTBPb3Kw\/UddApiGn9-I\/AAAAAAAABLE\/mriu5xh44dA\/s113\/ea37b7645cd78e7867d246cd755bc8d4.jpeg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-ub7tgAwh2ys\/XZeXWTgy8eI\/AAAAAAACobA\/wW6YZB569DAXE9sLUToXfuj59ZhT3CM9wCLcBGAsYHQ\/s72-c\/SQ%2B-%2Bpallimed%2Bwriters%2Bgroup.png","height":"72","width":"72"}}]}});