Unavailability of medicines is a current theme that causes a lot of problems and frustrations for patients, pharmacists and doctors. The ideal solution, of course, is to avoid the problem or find a solution before the unavailability manifests itself. Unfortunately, this is not always possible in practice. Therefore, the FAMHP tries to offer concrete solutions in consultation with all stakeholders and to communicate about this in a correct and transparent way. Our experts collaborate on structural solutions for unavailability at both national and European level.
In Belgium, marketing authorisation holders of medicinal products are required by law to report any unavailability to the FAMHP via the application PharmaStatus. If a firm cannot (fully) deliver a medicinal product within three working days and the order is intended to fulfil public service obligations, we speak of unavailability. Using a decision tree, the Unavailabilities Entity of the Proper Use Division determines the severity of the situation. Is there no alternative and is import from abroad not possible? If the answers to these questions are no, then we speak of a critical unavailability. Critical unavailabilities make up only a small part of all unavailabilities. Overall, 1.18 per cent of unavailabilities in 2022 were critical.
PharmaStatus is an application developed by the FAMHP that collects information about availability of medicines in Belgium. The application shows when medicines are new to the market, temporarily unavailable, when they are available again or when their marketing has been temporarily interrupted or definitively discontinued. PharmaStatus is updated in real time, any change is immediately visible.
Sophie Bruneel, department head of the Unavailabilities Entity, explains what happens when there is a critical unavailability: “A task force is then convened with physician specialists, professional associations and patient organisations. The Task Force makes recommendations: usually an alternative treatment is proposed, but sometimes priority is also given to certain indications and the Task Force can decide what to do with the remaining stock.”
A shortage or unavailability of a medicinal product is often due to manufacturing problems. This can range from staff shortages at the manufacturer, to a shortage of an active ingredient. An increased demand can also cause shortages, as we see with Ozempic, a medicine for the treatment of diabetes used outside its official indication for weight loss. Manufacturers rely on the sales they expect, they cannot simply accommodate increased demand at short notice if it was not anticipated. We do not always know the true cause of shortages but focus mainly on the solutions.
Of course, there are certain conditions attached to this. In July 2022, the royal decree on the substitution of unavailable medicines was issued. If the prescribed packaging of a medicine is unavailable, the pharmacist may give a different packaging size that is as close as possible to the prescribed medicine.
Ann Van Den broucke
“It is also important to know that unavailabilities are reported at pack level”, explains Ann Van Den Broucke from the Proper Use Division, “so an unavailability does not always concern the whole range of a medicinal product. For example, a pack containing effervescent tablets may be unavailable, but the pack containing classic tablets, syrup or suppos may still be available. Some other countries look at this at the medicine level, so the statistics are difficult to compare.”
“The FAMHP is constantly working on structural solutions to address the issue of unavailabilities,” Sophie Bruneel explains, “the main platform is the national Unavailability Working Group, in which every relevant stakeholder is represented. Despite each stakeholder defending its own interests, the focus of all present is on ensuring continuity for the patient.”
During the coronavirus crisis, the “stock monitoring tool” was launched for accurate monitoring of stocks of medicinal products used in the fight against COVID-19. Due to the added value of the tool during the crisis, it was decided to expand it to other medicinal products and launch a pilot phase. That would start in summer 2023 and will feature an automated system in addition to a manual one. Pharmacists, hospital pharmacists, wholesaler-distributors and manufacturers alike will have to report their stock on a weekly basis for nine active ingredients, equivalent to about fifty packages. Ann Van Den Broucke explains the purpose of this new tool: “Stocks of medicinal products that are becoming too small are spotted more quickly thanks to the tool, allowing quicker intervention. In case of (imminent) problems, there is also better visibility on the availability of alternative medicines and the location of the stock in the market.”
The availability of medicines is often a problem that crosses national borders. At the European level, the experts of the Unavailabilities Entity are working, among other things, on compiling a list of essential medicines. In Belgium, we also want to establish such a list and attach certain obligations or benefits to the medicines on that limited list to ensure that the availability of those products is better guaranteed in the future. The follow-up of the availability of medicines is also receiving more and more attention at European level. During international consultations, it appears that other member states are often not as far along in following up on unavailabilities as Belgium.
The unavailability of medicines is not a black-and-white story. These are often shortages that are quickly resolved. Together with our stakeholders, we look for the best solution for the patients who need a particular medicine the most. The well-being of the patient always comes first, which is what the experts at the FAMHP watch over.
Sophie Bruneel is head of the Unavailabilities Entity within the Proper Use Division. This Entity evaluates and investigates reports of shortages and actively seeks solutions. In cooperation with the Unavailability Working Group, the problem is being addressed at a higher level and structural solutions, such as legislative changes, are being sought.
Ann Van Den Broucke is in charge of management support for the Proper Use Division. She monitors the various projects within the department and is closely involved in the development of the PharmaStatus application. To this end, she collaborates with various experts, both inside and outside the FAMHP.