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Heroin Addiction and Related Clinical Problems: 2026, 28: 131-138

Should off-label prescription of controlled medicines be notified?

Caroline Schmitt-Koopmann, Carole-Anne Baud, Stéphanie Beuriot, Barbara Broers, Cheryl Dickson, and Olivier Simon

Digital Object Identifier:
https://doi.org/10.62401/2531-4122-2026-16

Summary: Background. In medical practice off-label prescription of medications, including controlled medicines, is common. Most countries have no legal provision for off-label prescription and use, but in Switzerland physicians are required to notify local health officials when they prescribe narcotic and psychotropic substances off-label. However, an exact definition of what constitutes off-label use is absent in the legal text. The aim of our study was therefore to investigate how this legal requirement is applied in practice. Methods. We investigated the definition and history of this provision and performed semi-structured interviews with 42 professionals from Switzerland’s local health authorities, on their experience with notifications. This work was undertaken as part of a Swiss National Science Foundation project on the regulation of controlled medicines. Results. We found that, even if off-label prescribing is common, officials receive only very few notifications. When they do, their analysis is superficial, sometimes a call for clarification, and archiving done without any action. The officials we interviewed had various definitions for off-label prescription and use as well as different opinions regarding the aims and usefulness of this legal requirement. Conclusions. Based on our findings and compared to other countries, we recommend that the federal legislator re-evaluates the necessity of obligatory notification for off-label prescription of controlled medications, in Switzerland.

Keywords: Off-label; Narcotics; Psychotropics; Regulation; Switzerland