National impact of a constraining regulatory framework on pregabalin dispensations in France, 2020-2022.

Background: Pregabalin is a drug approved for neuropathic pain, epilepsy and general anxiety disorder. However, pregabalin is also an increasing cause of diversion and misuse, and, for this reason, the French health authorities have decided in 2021 to classify it as a narcotic drug, requiring secured prescription pads. Our study aimed to evaluate the impact of this measure on pregabalin dispensation patterns.

Methods: Using data from a national representative sample of 12,690 French community pharmacies, we assessed the impact of the new regulatory framework, implemented in June 2021, on the total monthly quantity of pregabalin dispensed by conducting an interrupted time-series (ITS) analysis. We built a counterfactual model to predict what would have happened without the intervention. We conducted the same analyses in the subsample of pregabalin dispensations exceeding the maximum recommended dosage of 600 mg per day. Additionally, we compared (1) the number of pregabalin dispensations (2) the co-dispensing of opioids and/or benzodiazepines one year before and one year after the regulation.

Results: Following the regulatory change, there was an immediate and significant drop of 38,475,375 mg (95 %CI [-66,931,799 mg; -10,018,951 mg] in pregabalin dispensations. This decline continued in the following months, with a decrease of 4,788,107 mg (95 %CI: [-8,888,326 mg; -687,888 mg] per month. The counterfactual model predicted that, without the intervention, there would have been no notable change in pregabalin dispensations. The ITS analyses showed no significant change in pregabalin dispensations following the new regulation for the subsample with doses exceeding 600 mg per day. Concurrently, there was a significant decrease in co-dispensing of opioids (18.4 % pre-regulation versus 11.6 % post-regulation, p < 0.001) and benzodiazepines (21.4 % pre-regulation versus 11.7 % post-regulation, p < 0.001).

Conclusion: The constraining regulation adopted in 2021 by the French health authorities significantly curtailed total pregabalin dispensing in community pharmacies. Our findings underscore the importance of regulatory measures to limit the misuse of a prescribed medication.