Unavailability of medicines is a problem that affects many patients every year. This issue is therefore high on the agenda both at the national and international/European levels.. In recent years, the FAMHP has invested in a multifaceted approach to unavailable medicines with both practical actions on the ground and legislative initiatives.
At the FAMHP, every indication of a possible shortage is taken seriously and thoroughly analysed to assess the potential impact on public health. The FAMHP experts use a decision tree to analyse each unavailability, with a duration of one month or more, reported by the marketing authorisation holder or parallel distributor in order to estimate the impact on public health. This allows the FAMHP to take appropriate measures to minimise the impact of the unavailability on patients.
In the event of critical unavailability, a task force is convened to make recommendations and set priorities. That task force consists of experts for the specific medicine for which there is a shortage,” explains Lara Wellens of the Unavailabilities Entity. “In the task force there are doctors (specialists), pharmacists, professional associations, patient organisations and other government departments. They can, for example, propose an alternative treatment, but sometimes priority is also given to certain indications and so the task force can decide what happens to the remaining stock of the medicine.” Critical unavailability fortunately accounts for only a small portion of all unavailability. In 2023, a total of only 1.14 per cent of unavailabilities were critical.
“It is important to stress, however, that reports of unavailabilities happen per presentation of a medicine: in other words, based on the dose, route of administration, pharmaceutical form and pack size,” adds Lara, “so an unavailability does not always concern the whole range of the medicine. If the pack of 30 paracetamol of 1 gram tablets from a particular manufacturer is temporarily unavailable, it does not mean that the medicine is unavailable. Other packs of paracetamol, for example, may still be available and may provide a solution for patients at that time.”
The FAMHP is continuously investing in effectively addressing unavailability of medicines. In 2019, for instance, the agency launched the application PharmaStatus. Patients can use this to look up whether a medicine is available and they can register to be kept informed about the availability of a specific medicine or group of medicines. Authorisation holders and parallel distributors are legally obliged to supply wholesaler-distributors (within the scope of their own special obligations) and pharmacists within three working days. Partial or interrupted deliveries are automatically considered as an unavailability and must be reported through PharmaStatus. Since April 2021, pharmacists and wholesaler-distributors are also able to contact marketing authorisation holders and parallel distributors through PharmaStatus in the event they suspect a shortage or supply problems to occur. This system encourages companies to pass on their reports correctly.
If the problem cannot be solved locally, solutions are sought at the international/European level. “We werken daarom intensief samen met Europese netwerken. In sommige gevallen moeten we strategische voorraden aanleggen. Ook andere diensten binnen het FAGG, zoals de inspectiediensten, en andere overheidsinstanties zijn vaak betrokken om de situatie onder controle te krijgen. Via het Europees Geneesmiddelenbureau (European Medicines Agency, EMA) kan bijvoorbeeld een melding worden gestuurd naar alle leden van dat netwerk wanneer er een belangrijk tekort is. Dan wordt er gekeken in welke landen er nog alternatieve geneesmiddelen op de markt zijn.”
“A specific case that demonstrates the need for such measures is the shortage of thrombolytics. Thrombolytics are medicines that actively dissolve blood clots and are used in life-threatening situations such as a blocked blood vessel. Thrombolytics are used in cases of heart attack, pulmonary embolism, stroke or thrombosis, for example. These medicines are therefore crucial for saving lives,” Lara explains. “In late 2021, there was a quality issue with a widely used thrombolytic in Belgium that caused an acute shortage of this medicine in Belgium. Two alternative medicines could not provide a solution at that time because there was a global capacity problem. Belgium fell back on about fifty per cent of the need for thrombolytics at that time.”
As other countries were also facing supply problems for thrombolytics, no stock could initially be imported from abroad. The FAMHP therefore set up a controlled distribution for these medicines, whereby hospitals were given a monthly quota based on their historical consumption. Hospitals had to report their stock on a weekly basis. If the hospital’s stock fell below the threshold, they were able to receive a new supply. A task force was organised on a very regular basis during the period when the situation was very critical, even on a weekly basis for a certain period.
“It was a very uncomfortable situation for the hospitals because the consumption of thrombolytics can fluctuate from month to month,” notes Lara Wellens, “but this way, we did manage to avoid a complete stock-out. Belgium currently has a strategic stock of the unavailable thrombolytic. Hospitals can order from the FPS Public Health, but of course there are quotas that apply. The company producing the other thrombolytics has also done a great deal to increase production. Hospitals had protocols to deal with limited supplies, and we communicated and collaborated closely to ensure that available medicines were used as effectively as possible.”
The critical unavailability of thrombolytics was kept under control not only through the efforts of the hospitals, task force members and the FAMHP, but also through close contacts with pharmaceutical companies, other Member States and the European network. Other services within the FAMHP were also involved in this case: the inspection services and the experts of the directorate-general PRE authorisation have done a great deal of work. The National Institute for Health and Disability Insurance (NIHDI) also contributed through the task force. For example, they secured temporary reimbursement for thrombectomy devices, which can extract a clot from the blood.
“If there is one thing we are taking with us into the future, it is the importance of (inter)national cooperation and stock management. The pharma industry must continue to invest in diversifying manufacturing capacity. The experience of the thrombolytic shortage has provided a better understanding of the need for continuous monitoring, close cooperation between all players involved, and flexible solutions. Thorough coordination and collaboration in all aspects of this complex process, and effective crisis management are really essential to protect public health and save lives,” Lara concludes.
Lara Wellens
Our FAMHP experts
Lara Wellens is head ad interim of the Unavailabilities Entity within the Proper Use Division. Her team is responsible for daily monitoring of temporarily unavailable medicines or discontinuations of commercialisation of medicines. They work with various experts, both inside and outside the FAMHP. The unit also manages the PharmaStatus application, which was developed to collect information on the availability of medicines in Belgium.
