{"id":514,"date":"2018-03-07T13:33:35","date_gmt":"2018-03-07T18:33:35","guid":{"rendered":"https:\/\/sites.bu.edu\/dome\/?p=514"},"modified":"2018-03-07T13:33:35","modified_gmt":"2018-03-07T18:33:35","slug":"pharmacies-try-their-hand-at-opioid-policy","status":"publish","type":"post","link":"https:\/\/sites.bu.edu\/dome\/2018\/03\/07\/pharmacies-try-their-hand-at-opioid-policy\/","title":{"rendered":"Pharmacies Try Their Hand at Opioid Policy"},"content":{"rendered":"

The opioid crisis has continued to grab national attention, as total drug overdoses hit yet another historic high in 2016<\/a>.\u00a0 One of the nation\u2019s largest pharmacies, CVS, recently joined the debate by announcing a new national opioid policy.<\/p>\n

In February 2018<\/span><\/a>, CVS started capping new opioid prescriptions at a seven-day supply.\u00a0 Additionally, CVS is\u00a0limiting daily doses to 90 morphine milligram equivalents (MME) and requires medical providers to prescribe immediate-release opioids before attempting extended-release versions.\u00a0 The policy itself is unremarkable.\u00a0 CVS is merely adopting the CDC\u2019s prescribing guidelines<\/span><\/a>.\u00a0 In fact, 17 states<\/span><\/a> have done the same or equivalent, including Massachusetts<\/span><\/a>.\u00a0 And while it may appear strange for a retailer like CVS to forcibly limit its own sales, both pharmacies and pharmaceutical companies have faced a growing threat of litigation<\/span><\/a> in recent years over the marketing and sale of prescription opioids.<\/p>\n

Medical providers, chronic pain patients, and some drug policy experts have lodged a number of concerns in response to CVS\u2019s new policy.\u00a0 These concerns not only identify some of the closely held interests in the opioid debate but also demonstrate the challenges of developing effective policy against a crisis that is rapidly evolving.\"th\"<\/a><\/p>\n

The Costs<\/em><\/p>\n

Opioid policies fall into three main categories: preventive, treatment, and punitive. The CVS policy aims to prevent the development of new opioid use disorders (OUDs).\u00a0 In an effort to minimize unintended consequences, the policy carves out two administrative exceptions: first, doctors may request exemptions for certain patients, and second, employers and insurers can opt out of the program altogether.\u00a0 The CVS policy also aligns itself with CDC guidelines in exempting patients who are in \u201cactive cancer treatment, palliative care, or hospice care<\/span><\/a>.\u201d<\/p>\n

While this may reassure cancer patients, other patients with chronic pain have expressed cause for alarm.\u00a0 For one, their access to opioids is already subject to an ongoing and heated debate<\/span><\/a> within the medical community.\u00a0 Limited data on long-term opioid use for chronic pain management has bisected medical experts\u2019 opinions on the evidence base, ethics, and ramifications of prescribing decisions.\u00a0 In 2016, the CDC entered the fray.\u00a0 While its guidelines recommend heavily individualized opioid treatment decisions, the CDC director placed his thumb on the scale by declaring<\/span><\/a> that \u201c[m]anagement of chronic pain is an art and a science. The science of opioids for chronic pain is clear \u2014 for the vast majority of patients, the known, serious, and too-often fatal risks far outweigh the unproven and transient benefits.\u201d<\/p>\n

Chronic pain patients disagree that the data are so clear-cut.\u00a0 Moreover, they allege that the national opioid narrative is eliciting a fear-based response among medical providers at a negative cost to their treatment<\/span><\/a>.\u00a0 Chronic pain patients report that their providers increasingly treat them like \u201caddicts<\/span><\/a>,\u201d an inappropriately stigmatizing term<\/a> that in these cases also ignores critical diagnostic differences between substance dependency<\/em> and a substance use disorder<\/em><\/span>.\u00a0 The result can be forced reductions to a patient\u2019s opioid prescription without warning (known as involuntary tapering) or in extreme cases a blanket office policy against prescribing opioids altogether.\u00a0 It is early days\u2014too early for clear data in fact\u2014but reports of patient suicides in the wake of involuntary tapering have already surfaced<\/a>.<\/p>\n

\"opioid-1\"<\/a>The CDC does not expressly require<\/em> a physician to involuntarily taper a patient off of opioids.\u00a0 In fact, the CDC vests the authority for such individualized prescribing decisions in physicians. However, the DEA, which grants physicians\u2019 prescribing licenses, admittedly muddled that message when it proposed broad cuts to opioid production<\/a>: a 25% decrease in 2017 and a 20% decrease in 2018.\u00a0 Moreover, punitive DEA actions against physicians regarding opioid prescription conduct increased fivefold between 2011-2016<\/a>. \u00a0While the penalties are clear and steep (including loss of medical licensure and criminal charges<\/a>), what conduct triggers<\/em> those penalties is less clear.\u00a0 Thus, the combination of liabilities without a clear safe harbor incentivizes an overly strict interpretation of federal policies<\/a> in ways that may harm patients.<\/p>\n

Beyond the legal liabilities, physicians have also voiced concerns over the increasing intrusion of third parties into treatment decisions.\u00a0 The CVS policy allows a doctor to request exemptions for certain patients, but does not specify its criteria for granting exemptions or if there are caps on the number of exemptions a doctor may request or receive.\u00a0 Some doctors worry the additional administrative requirements to apply for CVS exemptions will burden<\/span> already overtaxed primary care physicians<\/a>, leaving patients with delayed or insufficient care<\/span><\/a>. \u00a0For example, one study<\/a> found that physicians already spend two hours on paperwork for every hour of treating patients.\u00a0 The CVS policy will increase that paperwork burden for physicians who choose to file for opioid patient exemptions.<\/p>\n

Without further research on long-term opioid use, clear safe harbors for prescribing compliance, and a significant increase in the number of medical specialists trained in pain management, some patients and doctors share the concern that this prevention policy will come at unintentional costs to patients with chronic pain.<\/p>\n

The Benefits<\/em><\/p>\n

\u00a0<\/strong>Much of policy derives from a cost-benefit analysis.\u00a0 If prescription opioids are the source of most new cases of OUDs, then some risk to patients with opioid dependencies (like those managing chronic pain) may arguably be worth strictly limiting their supply.\u00a0 Thus, the $78.5 billion<\/span><\/a> question remains: are prescription opioids presently <\/em>the main cause of new OUD cases?<\/p>\n

A growing subset of drug policy experts say no.\u00a0 While prescription opioids undoubtedly contributed to the opioid epidemic in the past, recent data<\/span><\/a> show that opioid prescriptions<\/em> continuously decreased<\/em> from 2010-2015. \u00a0During that same time span however, opioid mortalities<\/em> continuously increased<\/em>.\u00a0 In fact, heroin<\/span><\/a> increasingly represents the initiating opioid of use for new OUD cases, not oxycodone or other prescriptions.\u00a0 These data suggest that the over-prescription of opioids has been largely corrected and that new and stricter prescription limits moving forward may offer only marginal benefits.<\/p>\n

The debate over CVS\u2019s initiative mirrors many of the challenges of developing effective opioid policy at the state level.\u00a0 The opioid epidemic is rapidly evolving whereas drafting and passing legislation can take years to accomplish.\u00a0 In that same time span, the drop in prescription rates between 2010-2015 as well as the emergence of heroin as an initiating opioid have shifted the opioid epidemic, throwing into question<\/a> just recently passed prescription-focused legislation<\/a>.\u00a0 In short, the opioid crisis is both testing and demonstrating the limits of the legislative process.<\/p>\n

Second, even if a legislature could sustain a multi-decade focus on continually revising opioid legislation, any attempt to do so effectively <\/em>would require massive data gathering.\u00a0 Currently however, state medical examiners have already passed their breaking points, whether from running out of room<\/span><\/a>, running out of money<\/span><\/a>, or burnout<\/span><\/a>.\u00a0 Yet these examiners play a crucial role in accurately identifying the cause of death for overdoses.\u00a0 Thus, even accurately tracking changes in cause of death alone<\/em> would necessitate a massive influx of resources, in terms of additional personnel, time, and training for standardization.\u00a0 Beyond tracking overdoses, states would furthermore have to allocate additional resources to continuously monitor changes in initiating opioid use and to what extent supply limitations (like those currently placed on prescriptions) result in a substitute demand for more harmful illicit opioids like fentanyl.<\/p>\n

Third and finally, the unintended effects of legislation matter just as much as the intended.\u00a0 A complex mesh of societal, punitive, and regulatory forces have created powerful disincentives<\/span><\/a> for physicians to prescribe opioids or treat patients who need them. \u00a0In particular, the stigmatization of chronic pain patients incentivizes withholding treatment for moralistic rather than medical reasons.\u00a0 The threat of criminal prosecution and loss of medical licensure incentivizes avoiding even relatively benign conduct for fear of triggering DEA or state investigation.\u00a0 Finally, the paperwork barriers formed by each new layer of regulatory compliance incentivize avoiding time-consuming patients, like those who require opioids.\u00a0 Thus, the exemptions that CVS and other state policies designed to safeguard<\/em> individualized treatment decisions are likely insufficient to counterbalance the opposing disincentives. Effective policymaking requires a careful calculation of both direct and indirect incentives, far beyond the scope of a single prescription policy.<\/p>\n

Going forward, CVS (and the states) should consider policy alternatives that expand provider choices rather than restrict them.\u00a0 For example, CVS could begin offering the abuse deterrent formulations (ADFs) of opioids.\u00a0 The FDA recommends ADFs as they offer the same pharmacological benefits as regular opioids but exist in a form that is harder to physically alter for off-label use.\u00a0 Currently, CVS does not cover any of the ten ADFs approved by the FDA<\/span><\/a>.\u00a0 By offering a new prescriptive tool instead of restricting an existing one, this alternative might maintain some of the same intended preventive benefits without triggering an incentive to drop chronic pain patients.<\/p>\n

Moreover, the addition of ADF coverage would allow for greater flexibility on a state level.\u00a0 Many states<\/a> are in the process of or have recently completed crafting comprehensive legislative packages (including combinations of preventive, treatment, and punitive solutions).\u00a0 CVS\u2019s uniform national policy may interfere with these efforts and make addressing unique state needs more challenging than necessary.<\/p>\n

In summary, the benefits of CVS\u2019s opioid policy are unlikely to outweigh its harms.\u00a0 The CVS policy provides no new guidance as it merely mimics the existing CDC policy, but it does add new layers of time-consuming compliance for providers pursuing medically-valid exemptions.\u00a0 Pharmacies and other retailers would do better to provide additional support to the existing state and federal opioid infrastructure than begin imposing new requirements upon it.<\/p>\n

 <\/p>\n

\"Scott_Caitlin_U46725303\"<\/a>Caitlin Scott<\/strong> anticipates graduating Boston University School of Law in May 2019 and plans to practice Health Law.<\/p>\n","protected":false},"excerpt":{"rendered":"

The opioid crisis has continued to grab national attention, as total drug overdoses hit yet another historic high in 2016.\u00a0 One of the nation\u2019s largest pharmacies, CVS, recently joined the debate by announcing a new national opioid policy. In February 2018, CVS started capping new opioid prescriptions at a seven-day supply.\u00a0 Additionally, CVS is\u00a0limiting daily […]<\/p>\n","protected":false},"author":14561,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[10,5],"tags":[78,76,77,57,75],"_links":{"self":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/514"}],"collection":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/users\/14561"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/comments?post=514"}],"version-history":[{"count":6,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/514\/revisions"}],"predecessor-version":[{"id":565,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/514\/revisions\/565"}],"wp:attachment":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/media?parent=514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/categories?post=514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/tags?post=514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}