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Controlling controlled substances abuse and misuse by managed care payers: a new generation of risk management initiatives?

In their article titled “Impact of a drug utilization review program on high-risk use of prescription-controlled substances”, Matthew Daubresse and colleagues assess the reductions in problematic use of controlled medications as a result of an intervention consisting of a letter mailed to physicians and other prescribers based on an algorithm to detect improper use of controlled substances using insurance claims.1 The authors have conducted a study on an important topic, i.e., whether a drug utilization review program using a risk score developed by researchers at managed care organizations can accurately target use patterns of controlled substances suggestive of abuse and/or misuse among patients and can decrease the apparent problematic utilization. For this purpose, the authors created a controlled substance risk score based on three metrics: (i) the number and type of opioid and other controlled substances prescriptions dispensed; (ii) the number of prescribers and pharmacies where prescription opioids and other controlled substances were dispensed; and (iii) whether the number of prescriptions for opioids or other controlled substances increased over time. The authors developed the risk score based on experience, empiric observations managing pharmacy benefits, and published literature, but did not provide a justification for the criteria used or validate whether the controlled substance risk score accurately predicts misuse or abuse of controlled substances, although they used it to assess the impact of an intervention based on the outcome measure. For their study, two state health plans served as the intervention group and two state health plans as the control group. The intervention plans sent letters to healthcare providers of members whose controlled substance risk score exceeded a pre-specified threshold, while the control plans did not send such letters. The authors report that the reductions in the mean controlled substances score were greater in the intervention than comparison cohort. Changes were driven primarily by reductions in the number of prescriptions for controlled substances. The authors use a difference-in-difference design2 and generalized estimating equation models to quantify the impact of the program on the mean difference in reduction of the controlled substances score, which are appropriate and quite novel methodologies. However, the intervention design has some weaknesses that affect causal interpretation as outlined in the next paragraph. One consideration is the absence of validation of controlled substances risk score, which is used both to identify which patients to target for intervention and to measure whether the intervention was effective. In the urgency to act on the increasing deaths among people in whom opioids were found,3 and the growing body of literature about doctor-shopping (i.e., use of multiple doctors and pharmacies to obtain controlled substances for abuse or diversion), it is understandable to create controlled substances risk scores based on experience managing healthcare insurance plans. Daubresse et al. conclude that a letter sent to prescribers of patients with high controlled substances risk scores may be beneficial in reducing abuse or misuse of controlled substances. However, the controlled substances risk score that is both the prediction score and the outcome measure and is not validated for either purpose limits the ability to make strong causal inferences from the article’s results. A second consideration in interpreting the results is the downward trend in the controlled substances score that was observed for both the intervention and control *Correspondence to: Paul Coplan, Purdue Pharma, Epidemiology and Risk Management, Stamford, CT 06901, USA. Email: paul.coplan@pharma.com