In the fight against the new coronavirus, doctors are using medicinal products that were initially developed to treat other pathologies. The FAMHP summarises the actions and measures that have been taken.
Worldwide and indeed in Belgium, scientists are working to research and develop new medicines to treat COVID-19 and new vaccines to protect us from the new coronavirus. The effect of existing medicinal products is also being evaluated in hospitals on patients with serious cases of COVID-19.
What medicinal products are used?
The situation changes every day, as does scientific knowledge of possible treatments. Sciensano, the Belgian health institute, regularly adapts its directives for the treatment of hospitalised patients according to new scientific knowledge. For now, the emphasis is mainly on antimalarials and antivirals used, for example, to treat HIV. These medicinal products are as follows: Plaquenil (hydroxychloroquine), chloroquine phosphate, remdesivir and Kaletra (ritonavir/lopinavir).
For which patients?
Only patients who are seriously ill and hospitalised can be treated with these medicinal products. Good medical monitoring is necessary, because there is not yet enough scientific evidence that these medicinal products are effective against COVID-19. Furthermore, there are also risks. These medicinal products are therefore not recommended for patients with mild symptoms or for preventive use.
For patients who are not hospitalised, treatment aims to alleviate the symptoms and paracetamol remains the first choice for fever reduction and pain relief.
Can one use existing medicinal products for a new illness?
There are certain situations in which an existing medicinal product may be used for a new illness.
- compassionate use or medical need programme.
Urgent medical need or compassionate use programmes can be used when a patient or group of patients suffering from a chronic, seriously disabling or life-threatening illness cannot be satisfactorily treated.
- Clinical trials
Clinical trials are scientific research performed on humans. Trials of (potential) medicinal products are based on the most advanced scientific developments before being made available to the general public. For example, thanks to clinical trials, test subjects can have access to innovative new treatments even before they are placed on the market.
- Off-label use
Off-label use is when medicinal products are used for a different indication (for example, a different condition, dosage or group of patients) to that mentioned in the package leaflet; in other words, uses for which the medicinal product is not authorised. Doctors have the therapeutic freedom to prescribe medicinal products off-label; however, they must thoroughly examine this usage, giving particular attention to scientific evidence and potential risks. Doctors must inform patients in advance that the usage is not indicated in the package leaflet and of any associated risks. Off-label usage is not recommended here as no statistically relevant clinical data is generated.
Are there large-scale clinical trials in Belgium?
Belgium participates in the DISCOVERY study run by the French public research centre INSERM. In total, 3,200 patients are participating in the study, including 400 Belgians.
Are there any risks involved in using these medicinal products?
Clearly there are many things we don’t know about the new use of these existing medicinal products. None of them has been proven effective against COVID-19. Scientific knowledge is increasing every day, but positive results on a small-scale cannot be used to justify unlimited use of these medicinal products. Furthermore, these are medicinal products that are already used to treat very serious illnesses. There are therefore known (serious) adverse effects and interactions with other medicinal products, which means that they need to be handled with extra caution.
What measures has the FAMHP already taken?
The existing medicinal products are produced for chronic patients afflicted with serious illnesses and it is extremely important that the treatment of these patients is not compromised. The FAMHP has therefore taken measures to distribute Plaquenil, chloroquine phosphate et Kaletra in a controlled manner so that they only go to hospitals or to chronic patients. The FAMHP has decided to impose quotas on pharmaceutical companies for medicinal products based on azithromycin. Deliveries to wholesaler-distributors must not exceed the habitual quantities.
Each hospital receives hydroxychloroquine for the treatment of seriously ill COVID-19 patients. The total stock available is 64 kg, which is enough to treat 22,000 patients. 50 kg of chloroquine phosphate will follow this week, enough to treat 9,000 patients. A strategic stock of Kaletra will also be distributed to the hospitals.
In order to ensure that all patients presenting mild flu symptoms have access to over-the-counter medicinal products and to avoid people stocking up pointlessly, the FAMHP has decided that pharmacists should only be able to dispense a single box of paracetamol per person.
The coronavirus pandemic is an absolute priority for the FAMHP, as much for our own working processes as to help our partners (other public institutions, hospitals, doctors, pharmacists, etc.).