Pharmacies Try Their Hand at Opioid Policy
The opioid crisis has continued to grab national attention, as total drug overdoses hit yet another historic high in 2016. One of the nation’s 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. Additionally, CVS is limiting daily doses to 90 morphine milligram equivalents (MME) and requires medical providers to prescribe immediate-release opioids before attempting extended-release versions. The policy itself is unremarkable. CVS is merely adopting the CDC’s prescribing guidelines. In fact, 17 states have done the same or equivalent, including Massachusetts. 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 in recent years over the marketing and sale of prescription opioids.
Medical providers, chronic pain patients, and some drug policy experts have lodged a number of concerns in response to CVS’s new policy. 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.
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). 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. The CVS policy also aligns itself with CDC guidelines in exempting patients who are in “active cancer treatment, palliative care, or hospice care.”
While this may reassure cancer patients, other patients with chronic pain have expressed cause for alarm. For one, their access to opioids is already subject to an ongoing and heated debate within the medical community. Limited data on long-term opioid use for chronic pain management has bisected medical experts’ opinions on the evidence base, ethics, and ramifications of prescribing decisions. In 2016, the CDC entered the fray. While its guidelines recommend heavily individualized opioid treatment decisions, the CDC director placed his thumb on the scale by declaring that “[m]anagement of chronic pain is an art and a science. The science of opioids for chronic pain is clear — for the vast majority of patients, the known, serious, and too-often fatal risks far outweigh the unproven and transient benefits.”
Chronic pain patients disagree that the data are so clear-cut. Moreover, they allege that the national opioid narrative is eliciting a fear-based response among medical providers at a negative cost to their treatment. Chronic pain patients report that their providers increasingly treat them like “addicts,” an inappropriately stigmatizing term that in these cases also ignores critical diagnostic differences between substance dependency and a substance use disorder. The result can be forced reductions to a patient’s opioid prescription without warning (known as involuntary tapering) or in extreme cases a blanket office policy against prescribing opioids altogether. It is early days—too early for clear data in fact—but reports of patient suicides in the wake of involuntary tapering have already surfaced.
The CDC does not expressly require a physician to involuntarily taper a patient off of opioids. In fact, the CDC vests the authority for such individualized prescribing decisions in physicians. However, the DEA, which grants physicians’ prescribing licenses, admittedly muddled that message when it proposed broad cuts to opioid production: a 25% decrease in 2017 and a 20% decrease in 2018. Moreover, punitive DEA actions against physicians regarding opioid prescription conduct increased fivefold between 2011-2016. While the penalties are clear and steep (including loss of medical licensure and criminal charges), what conduct triggers those penalties is less clear. Thus, the combination of liabilities without a clear safe harbor incentivizes an overly strict interpretation of federal policies in ways that may harm patients.
Beyond the legal liabilities, physicians have also voiced concerns over the increasing intrusion of third parties into treatment decisions. 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. Some doctors worry the additional administrative requirements to apply for CVS exemptions will burden already overtaxed primary care physicians, leaving patients with delayed or insufficient care. For example, one study found that physicians already spend two hours on paperwork for every hour of treating patients. The CVS policy will increase that paperwork burden for physicians who choose to file for opioid patient exemptions.
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.
Much of policy derives from a cost-benefit analysis. 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. Thus, the $78.5 billion question remains: are prescription opioids presently the main cause of new OUD cases?
A growing subset of drug policy experts say no. While prescription opioids undoubtedly contributed to the opioid epidemic in the past, recent data show that opioid prescriptions continuously decreased from 2010-2015. During that same time span however, opioid mortalities continuously increased. In fact, heroin increasingly represents the initiating opioid of use for new OUD cases, not oxycodone or other prescriptions. 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.
The debate over CVS’s initiative mirrors many of the challenges of developing effective opioid policy at the state level. The opioid epidemic is rapidly evolving whereas drafting and passing legislation can take years to accomplish. 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 just recently passed prescription-focused legislation. In short, the opioid crisis is both testing and demonstrating the limits of the legislative process.
Second, even if a legislature could sustain a multi-decade focus on continually revising opioid legislation, any attempt to do so effectively would require massive data gathering. Currently however, state medical examiners have already passed their breaking points, whether from running out of room, running out of money, or burnout. Yet these examiners play a crucial role in accurately identifying the cause of death for overdoses. Thus, even accurately tracking changes in cause of death alone would necessitate a massive influx of resources, in terms of additional personnel, time, and training for standardization. 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.
Third and finally, the unintended effects of legislation matter just as much as the intended. A complex mesh of societal, punitive, and regulatory forces have created powerful disincentives for physicians to prescribe opioids or treat patients who need them. In particular, the stigmatization of chronic pain patients incentivizes withholding treatment for moralistic rather than medical reasons. The threat of criminal prosecution and loss of medical licensure incentivizes avoiding even relatively benign conduct for fear of triggering DEA or state investigation. Finally, the paperwork barriers formed by each new layer of regulatory compliance incentivize avoiding time-consuming patients, like those who require opioids. Thus, the exemptions that CVS and other state policies designed to safeguard 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.
Going forward, CVS (and the states) should consider policy alternatives that expand provider choices rather than restrict them. For example, CVS could begin offering the abuse deterrent formulations (ADFs) of opioids. 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. Currently, CVS does not cover any of the ten ADFs approved by the FDA. 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.
Moreover, the addition of ADF coverage would allow for greater flexibility on a state level. Many states are in the process of or have recently completed crafting comprehensive legislative packages (including combinations of preventive, treatment, and punitive solutions). CVS’s uniform national policy may interfere with these efforts and make addressing unique state needs more challenging than necessary.
In summary, the benefits of CVS’s opioid policy are unlikely to outweigh its harms. 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. 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.
Caitlin Scott anticipates graduating Boston University School of Law in May 2019 and plans to practice Health Law.