As of November 29, 2024, pursuant to this decree and to prevent any interruption in treatment that could be harmful to the patient’s health, community pharmacists may dispense the medications and medical devices necessary to continue the chronic treatment of a patient whose renewable prescription has expired, through successive one-month dispenses—up to a maximum of three months.
The National Council of the Order of Pharmacists (Conseil national de l’Ordre des Pharmaciens, CNOP) summarizes the origins of this provision as follows: “Initially, this measure applied to the exceptional renewal of medicinal products, limited to a single unit per prescription line. The 2022 Social Security Financing Act (LFSS) extended this measure to medical devices, and the Rist Act subsequently lengthened the exceptional dispensing period from one to three months. ”
This is thus referred to as “exceptional additional dispensing.”
A regulated “exceptional additional dispensing”
This expansion of pharmacists’ authority in the care of patients with chronic conditions is subject to several conditions, intended to regulate this practice — likely to prevent it from overstepping [more than initially intended] on physicians’ authority.
First, this exemption is explicitly described as being intended for use “on an exceptional basis.”
Second, the decree makes this exemption subject to the fulfillment of three cumulative conditions:
- The expired renewable prescription must include a prescription for the product [medicinal product or medical device] for a total treatment duration of at least three months
- The product must not be covered by the order (‘arrêté’) of February 5, 2008, issued pursuant to Article L. 5125-23-1 of the Public Health Code — in other words, the following are excluded from this exceptional exemption:
- Narcotic drugs or drugs to which narcotic drug regulations apply in whole or in part
- Certain medicinal products, psychotropic substances, or substances likely to be used for their psychoactive effects, for which the prescription duration has been limited to less than twelve months for public health reasons by the Director General of the National Agency for Medicines and Health Products Safety, following the opinion of the National Council of Pharmacists (CNOP) and the National Council of the Order of Physicians (Conseil national de l’Ordre des Médecins, CNOM).
- The first dispensing must take place within one month of the prescription’s expiration.
Third, the pharmacist performing the exceptional dispensing is required to notify the prescribing physician as soon as possible, in order to ensure the confidentiality of the communication [by prioritizing the use of secure messaging systems that comply with interoperability standards].
An “exceptional additional dispensing” under scrutiny
While the CNOP published an article summarizing the content of the November 2024 decree without making any specific commentary on its implications for the duties of community pharmacists, the CNOM decided to draw physicians’ attention to the following points:
- “ The pharmacist acts outside the framework of a healthcare team coordinated by the physician and outside any organizational protocol;
- Consequently, a pharmacist who provides the physician with information a posteriori regarding an exceptional additional dispensing will bear sole responsibility toward the patient, and the information provided to the physician a posteriori will not serve to mitigate that responsibility;
- The National Council considers that the renewal of the medical prescription, the duration of which has been set by the physician, is the time for reassessing the patient’s state of health;
- The National Council reiterates that the medical prescription, the renewal of treatment, and its adjustment fall within the physician’s scope of competence. Therefore, the National Council has invited the public authorities to evaluate the measure to ensure its implementation is strictly exceptional.” ”
This position thus reflects the CNOM’s questions — even its perplexity — regarding this expansion of pharmacists’ prerogatives, particularly concerning the definition of responsibilities and the oversight of its “exceptional” use, especially in light of the medical monopoly.
In any case, it is clear that the central role of pharmacists in the care of patients with chronic conditions is being further strengthened — and thus reaffirmed — by public authorities.
These provisions are codified in Articles R.5123-2-1 [for drugs] and R.5211-74 [for medical devices] of the Public Health Code.
Written by Lorena Goudenège
