#TSSS2505850AOrder of February 20, 2025 setting the list of similar biological groups substitutable by the community pharmacist and the conditions of substitution and information for the prescriber and patient
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This law sets new guidelines for pharmacists in France on which similar biological medicines they can substitute for prescribed ones. It details several specific groups of biologics that can be interchanged under certain conditions, impacting both pharmacists and patients in terms of medication management. Pharmacists will need to inform prescribers and patients about these substitutions and maintain a record for traceability, ensuring consistent patient care.
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Key Changes
- Pharmacists can substitute specific biologic medicines with similar ones.
- Prescribers and patients must be informed about the substitutions.
- The law requires traceability records for all dispensed biologics.
Obligations
What this law requires
Pharmacists must inform patients at the time of dispensation about the actual substitution of the prescribed biological medicine and provide associated useful information, including storage rules for the dispensed medicine.
Pharmacists must inform the prescriber of which biological medicine was actually dispensed to the patient.
Pharmacists must record the name of the substituted biological medicine and its batch number using appropriate means to ensure traceability as required for all biological medicines.
Pharmacists must note on the prescription the name of the biological medicine actually dispensed.
Pharmacists must ensure continuity of dispensation by providing the same biological medicine in subsequent dispensations, except when patient feedback warrants a return to the originally prescribed specialty.