For all questions regarding the unavailability of a medicine, please contact the Proper Use division at email@example.com.
ROLE OF THE FAMHP AND LIST OF TEMPORARILY UNAVAILABLE MEDICINES
Since 1 January 2014, the FAMHP publishes a detailed list of temporarily unavailable medicines packaging on its website.
- List of temporarily unavailable medicines packaging for human use
- List of temporarily unavailable medicines packaging for veterinary use
These lists are updated daily (on working days) based on notifications provided by companies holding marketing authorisations (MA)/medicines registrations.
CAUSES OF UNAVAILABILITY OF MEDICINES
A medicine may be unavailable for different reasons:
- Actual unavailability
- Marketing discontinued
- Distribution problem
Real unavailability of a medicine or a real stock shortage caused for example by:
- a manufacturing problem,
- a quality problem,
- the unavailability of a raw material,
- a logistical problem (e.g. transport),
- force majeure.
In such cases, the MA/registration holder cannot deliver the products.
When the company holding the MA/registration decides to withdraw a product from the Belgian market, it will no longer be available in Belgium.
The FAMHP does not have the competence to force a company to market a medicine.
Marketing may be temporarily or permanently discontinued.
A medicine may be unavailable only in some pharmacies or at some veterinarians due to a local distribution problem. In that case the medicine is not really unavailable.
Another cause is the failure to respect the principle of quotas. Applying quotas is a practice used by some pharmaceutical companies to deliver their stocks in a controlled manner. On the basis of the previous year’s consumption, the company estimates the quantity of medicines that must be produced annually to meet the needs of the Belgian market and limits the periodic delivery to ensure that the number of lots is sufficient to supply the Belgian market throughout the year.
In such cases of unavailability, the company still has lots of stock available, but the pharmacist is unable to order it via the wholesaler-distributor. In practice, such cases are not notified to the FAMHP because they rarely last more than 14 days, usually only occur at the end of the month and the drug is available again at the beginning of the following month.
For the patient, the problem remains the same, i.e. they cannot get their medication, or the pharmacist needs to take additional steps to get it.
NUMBER OF UNAVAILABLE PRODUCTS
Notifications of unavailable medicines packaging represent on average 5% (July 2019 data) of the total number of packages marketed in Belgium. The FAMHP is working to raise awareness in companies holding marketing authorisations (MA)/registrations of the importance of notifying the unavailability of medicines packaging. In this way, the increase in the number of packaging notified as unavailable does not demonstrate an increase in unavailability itself but an increase in notifications of unavailability.
It is very important to understand that a product notified as unavailable concerns a medicine that is unavailable only to a certain degree, with a certain type of administration, in a certain pharmaceutical form, and in a certain package size: the entire range of the medicine is not actually unavailable.
SOLUTIONS AND ACTIONS
Multiple approach: field actions and legislative framework
In recent years, the FAMHP has allocated new resources to the management and monitoring of medicines unavailability. Several recent actions have provided a more comprehensive and effective approach to address the unavailability of medicines.
- Strengthening the procedure for tracking unavailability notifications by systematically sending e-mails to pharmaceutical companies requesting them to update their unavailability notifications.
- Application of the law which entered into force on 18 May 2019: the implementing decree will provide a stricter definition of unavailability and strengthen the obligation to notify unavailability, which will allow the FAMHP to take more stringent measures. Medicines that are not available for three working days will be considered unavailable. The obligation for pharmaceutical companies to deliver to wholesaler-distributors will also be set at three working days.
- Analysis of every unavailable product according to a decision tree showing the criticality of unavailability. Based on this decision tree, FAMHP experts assess each unavailable product notified by the marketing authorisation (MA)/registration holders in order to measure its impact on public health.
The FAMHP can then put in place the appropriate measures to limit the impact of unavailability for patients as much as possible. The evaluation is based on specific criteria that take into account the duration of the unavailability, the number of alternative medicines available (i.e. with the same active substance, strength, type of administration, pharmaceutical form) and the therapeutic indication(s).
When unavailability may be at risk, the FAMHP contacts the manufacturer of the medicine concerned for further information as well as the manufacturers of alternative medicines in order to foresee any possible increase in orders.
This upstream monitoring and evaluation work has made it possible to compensate for certain drug shortages.
For For most of the unavailable packaging, the expected duration of unavailability is less than one month or there are at least three alternatives that simultaneously meet the following criteria:
- having the same active substance,
- having the desired dosage,
- having the same type of administration,
- for certain medicines: having the same pharmaceutical form (with the same pharmacological characteristics, e.g. sustained release vs modified release).
For the remaining unavailable packaging:
- one third can be solved by one or two identical alternatives;
- for the rest of the cases where major problems could arise, the following options exist:
a) After analysis by experts, unavailability of products can be solved by an alternative with another active ingredient or a magistral preparation. The type of administration however, may differ.
b) The FAMHP’s may grant a derogation to a company (at its request) to allow it to temporarily import batches of the same medicine into Belgium. The patient receives the same drug with the same reimbursement conditions.
c) On the basis of a medical prescription and a doctor’s statement (Article 105 of the Royal Decree of 14 December 2006), a pharmacist may import the same medicine that is still available in other countries of the European Union in cases where there is no similar medicine authorised/registered in Belgium. The temporary import allows patients to receive a medicine with the same active substance, the same packaging size but with a patient information leaflet and box in a language other than the Belgian national languages. In such cases, the patient may pay more for the medicine.
d) In cases of unavailability of medicines for which there are no alternatives (called critical medicines), a task force comprising experts from the FAMHP, INAMI and external experts, meets. The task force makes recommendations to guide health professionals:
- via the rational use of the available medicine stock (e.g. prioritise the indications of the unavailable drug);
- possible solutions in the event of total unavailability and lack of alternatives.
The FAMHP is well aware that a change of treatment is not insignificant: risks of confusion, errors, under- and over-dose when changing to another medicine (different registered name, packaging, colour, etc.) or, when the medicine is imported (different packaging, language, etc.). Therefore, the change of treatment must be carried out under the supervision of the doctor or pharmacist. They are the key to good therapy.
The unavailability of medicines is a problem not only in Belgium but throughout the European Union, and even worldwide.
This is why consultations and the exchange of information are systematically organised at European level. FAMHP experts regularly consult the competent authorities of the other European Member States to find joint solutions.
Tools for more transparent information
The FAMHP wishes to improve information to health professionals and patients about the unavailability of medicines. To this end, a needs analysis was carried out with the various patient associations and health professionals. To achieve even greater transparency, the FAMHP developped a new online platform in which the results of the criticality analysis of each unavailable product, as well as the experts’ recommendations, will be published.
Information about criticality, recommendations and alternative solutions will be integrated into SAMv2, which is the authentic source of medicines, allowing doctors and pharmacists to be informed of unavailable medicines and possible solutions.