Regulation of unused medications proposed

A new decree proposal aims to create an experiment for regulating the redistribution of unused medications. This initiative requires approval from the Council of State and will begin on January 1, 2027, for a period of three years. It focuses on oral anticancer medications collected and redistributed by pharmacies for internal use (PUI), under the framework of Ecomed and led by Unicancer and the national federation of Cancer Fighting Centers (CLCC).

Strict rules for medication collection

The proposal outlines strict collection criteria and pharmaceutical controls, ensuring medications are in "intact, inviolable and perfectly identifiable" packaging. Medications sensitive to light or humidity must have intact blisters, while others can have opened secondary packaging if it is complete. Traceability information must be legible, and medications must have a sufficiently long expiration period. The collection must occur within three months of initial dispensation, and a standardized questionnaire will ensure proper storage conditions.

Pharmacist-led redistribution with safeguards

The redistribution of collected medications will be managed by an identified pharmacist from the PUI. Medications can be redistributed only once, either to a hospitalized patient or through retrocession. A documented pharmaceutical evaluation must confirm the absence of risk, and patients must be informed to make an informed choice. Refusals will be recorded in a document defined by decree, while the absence of explicit opposition will be noted in the patient’s shared medical record (DMP). Each PUI must implement a quality assurance system, and professionals will be trained to report any adverse effects.

Monitoring and evaluation of the program

A steering committee, chaired by the Ministry of Health, will meet at least twice a year to monitor the program, involving participating establishments, hospital federations, professionals, and user representatives. The program can be suspended if issues arise. An independent committee will assess the benefit-risk ratio, adverse events, economic balance, and environmental impact using life cycle analysis (LCA). The final report will guide the ministry in deciding whether to generalize, extend, or terminate the program.

No city-level redistribution planned

The proposed initiative does not include any redistribution at the city level. Pharmacies will collect unused medications through Cyclamed without intervening in their future use. Muriel Dahan, director of research and development at Unicancer, suggested in an interview with Le Moniteur des pharmacies that pharmacists could eventually be involved, provided strict guarantees of quality, safety, and traceability are maintained.