LAUSR

We were excited to read “Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base” by Ranapurwala et al. This paper provides a thoughtful assessment of the epidemiologic evidence that has been available to federal agencies, such as the Centers for Disease Control and Prevention (CDC), to inform policies around opioid analgesic prescribing. Given the urgency of the opioid crisis in the United States, public health officials could not wait for high‐quality evidence. They had to develop the most rational policies possible based on the limited evidence available, in conjunctionwith consensus opinion of experts, as acknowledged by CDC in their 2016 guideline for opioid prescribing for chronic noncancer pain patients in primary care settings.Widespread adoption of these policies, however, has resulted in unintended consequences for prescribers and patients, as “one‐size‐fits‐all” prescribing practices understandably do not meet the needs of all patients for the treatment of pain associated with various etiologies. This paper provides detailed insights into the limitations of the studies on which the guideline was based; this type of critical analysis is crucial for improving the evidence base available to inform opioid‐prescribing policies. The authors' recommendations for improving the epidemiologic evidence around the use of different prescribing practices to decrease the risk for opioid overdose, death, and development of opioid use disorder (OUD) are grounded in sound epidemiologic practice and drug safety research. FDA also recommends assessment of all potential confounders, use of causal diagrams, and use of sensitivity and quantitative bias analyses to inform the appropriate interpretation of drug safety studies. The authors recommend further evaluation of exposure misclassification and validation of exposures and outcomes that are identified using administrative claims data. We agree with these recommendations, and are sponsoring this type of work through