#SPRS2303274AOrder of January 31, 2023, Specifying Medical Situations for Exclusion of Drug Substitution
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The law defines situations where a doctor in France can opt out of substituting a prescribed drug with another similar drug group. For children under six, if no suitable form of the hybrid drug is available, or if a patient has a proven allergy to an excipient present in alternatives, substitution can be excluded. Doctors must indicate these conditions on prescriptions.
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Key Changes
- Doctors can refuse drug substitution for children under six when no suitable form is available.
- Substitution can be avoided if a patient is allergic to an excipient in alternative drugs.
- Doctors must note these exceptions on prescriptions.
Obligations
What this law requires
Prescribers must exclude drug substitution for children under six years old when no suitable pharmaceutical form of the hybrid drug group is available in the hybrid groups registry, provided the reference specialty has an appropriate form for administration.
Prescribers must exclude drug substitution when a patient has a formal and demonstrated contraindication to a notable excipient present in all available specialties of the same hybrid drug group, provided the corresponding reference specialty does not contain that excipient.
When invoking a medical justification for exclusion of substitution, prescribers must indicate this on the prescription in written form (either digitized or handwritten).
Prescribers must use the notation 'non substituable (EFG)' on prescriptions when excluding substitution for children under six due to lack of suitable pharmaceutical form.
Prescribers must use the notation 'non substituable (CIF)' on prescriptions when excluding substitution due to patient contraindication to an excipient in alternative drugs.