As the country faces an unprecedented opioid epidemic, there’s an active national conversation about how inappropriate prescribing contributes to chronic opioid use, misuse, and addiction. Evidence is rapidly evolving to inform the policy debate, especially regarding best practices for prescribing in acutely painful conditions, like an injury or surgery, but the evidence is less clear on the best policy solutions. Two new publications by LDI Fellows highlight issues around opioid ‘overprescribing’ and efforts to curb it.

Almost half of U.S. states have prescribing limits on opioids for acute pain, and the Centers for Medicare and Medicaid Services recently proposed a 7-day supply limit for new opioid prescriptions for Medicare beneficiaries. In line with this trend, the Comprehensive Addiction and Recovery Act (CARA) 2.0, a bipartisan bill introduced in the U.S. Senate in the spring of 2018, would impose a 3-day supply limit for new opioid prescriptions, which is more restrictive than current prescribing limits in many states. If CARA 2.0 passes, the current patchwork of state policies would be replaced with more restrictive national limits.

In The Annals of Emergency Medicine, Kit Delgado, Jeanmarie Perrone and colleagues examine the association between the amount of opioid prescribed to opioid naïve patients for a minor injury (ankle sprain), and risk of prolonged use. In that study, among the 30,000 patients who presented to the ED, a quarter of them received an opioid prescription. Most prescriptions were written in line with guidelines for a 3-day supply and had a total morphine milligram equivalent (MME) of 100 or less.

Higher volume opioid prescriptions were associated with a markedly increased risk of continued use. For example, patients who received a total MME of greater than 225 (equivalent to more than 30 5mg tabs of oxycodone) were five times more likely to transition to continued use, compared to those who received a total MME of 75 or less. Policies to restrict opioid prescriptions often focus not on MME but on days’ supply. The authors point out that prescriptions greater than 225 MME could still fall within 5- or 7-day supply-limit policies – suggesting that such policies may not, in and of themselves, minimize risk of continued opioid use.

In a New England Journal of Medicine Perspective, Maggie Lowenstein, David Grande, and Kit Delgado point out that although it is critical to minimize unnecessary opioid prescribing, we don’t know whether increasingly strict legal mandates are the best solution. The authors discuss a key problem with prescribing limits based on ‘days supplied’: it’s not clear whether limits of three, or five, or seven days of opioids meaningfully reduce the amount of opioids prescribed, or how these durations affect long-term use. The authors note that “we know even less about how limits affect the risks of developing opioid use disorder or risk of overdose, which is increasingly driven by use of heroin and synthetic opioids like fentanyl.”

The number of days that a prescription covers is an imprecise measure. The days supplied can be specified by the prescriber according to the start and end date of the prescription, or a pharmacist can calculate this according to dosing instructions. This means that the number of tablets dispensed per prescription can vary even for the same number of days supplied. There’s a push to instead consider MME as a more precise measure for standardizing opioid prescribing levels.

Lowenstein and colleagues make the point that opioid prescribing for acute pain is not a one-size-fits-all situation. For many self-limited conditions such as sprains and strains, most patients do not need opioids in the first place, and for many other indications, a 3-day medication supply—or even less –is sufficient to manage acute pain. However, they also point to evidence of variation in postoperative opioid needs depending on procedure severity, suggesting that the strictest limits may not be in the best interest of every patient.  

Any supply-limit standard needs to strike the right risk-benefit balance. Lowenstein and colleagues argue that while it is critical to limit opioid exposure when possible, we should be cautious about restrictions that may be too blunt of an instrument to serve patients with varied needs. They warn that increasingly strict legislation outpaces the quality of the evidence, and suggest some practical approaches to balance the necessary reduction in population-level risk while meeting the needs of patients:

Lowenstein and colleagues also recognize that given the current crisis, policies may need to be adopted on the basis of incomplete evidence. They advocate rapid evaluation of prescribing policies, as well as developing and implementing guidelines based on indication and clinical situation, supported by the use of technology such as electronic health record defaults. To fully address the opioid epidemic, they also emphasize the need to advance policies beyond prescribing restrictions and press for a significant and sustained commitment to treatment, harm reduction, and preventive measures addressing social determinants of health.

Dr. Delgado’s study is supported by a pilot grant from the Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (CHERISH), a National Institute on Drug Abuse-funded Center of Excellence (P30DA040500).