Deficiencies, France is preparing countermeasures that could set the standard
Fedaisf editorial staff
Against shortages and out of stock in the pharmaceutical supply chain, France is preparing to adopt measures that could become a point of reference for other European countries. Article 36 of the health care reform bill (Loi de santé), approved at the beginning of the month by the Chamber of Deputies in second reading and from Monday to be examined by the Senate, dictated them. In essence, the text entrusts the Ministry of Health with the task of drawing up and keeping updated a list of the so-called Mitm (Médicaments d'intérêt thérapeutique majeur, drugs of greatest therapeutic interest), on which specific restrictions will apply from 2016 on producers and distributors. Wholesalers, to begin with, will not be able to export the products on this list or resell them to a parallel trader; companies, on the other hand, will have to prepare a shortage management program for each medicine, including a "plan B", to be triggered in the event of interruptions in the production cycle (for example, procuring an alternative supplier if the supplies of raw materials fail ). Brussels may not like these measures, but in the meantime France is going down with an iron fist.
To the pharmacies of the territory, then, the text acknowledges a crucial role in contrasting shortages and unavailability. First of all, pharmacists are allowed to "replace" the missing medicine with a corresponding imported product, obviously authorized by the French Medicines Agency. Secondly, pharmacies are invited not to interrupt the monitoring of breakages and deficiencies started by the Order a couple of years ago: "it is appropriate" observed the General Directorate of Health of the Ministry of Health "that pharmacists continue to report all cases of unavailability they come across.
As reported by the specialized magazine Le Quotidien du Pharmacien, the French owners are already working to translate into reality the indications that will arrive from the Loi de Santé. In fact, by the summer of next year, the 90% of pharmacies should have an integrated management system with "Dp-Ruptures", a sort of add-on to the "Dossier pharmaceutique" (the computerized patient file) programmed to automatically send via web to the manufacturer a report of unavailability (in case of unavailability from two wholesalers consecutively).
The effectiveness of Dp-Ruptures emerged in all its evidence last March, when an epidemic of conjunctivitis quickly made eye drops and ophthalmological drugs disappear in all the pharmacies of the island of Reunion, a French overseas colony. Alerted by automatic signals from pharmacies, French companies immediately arranged for emergency supplies to be sent by plane rather than by ship, as is normally the case. As a result, pharmacies were able to start dispensing again within the next 24 hours instead of waiting a week.