Belgian AFMPS latest guidance in the context of COVID-19 outbreak

The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. They cover important topics such as direct-to-patient dispensing of medicinal products in clinical trials, the Belgian Federal government's Task Force to remedy the shortage of medical protection equipment or measures to ensure continuity of treatment for patients suffering from chronic diseases.

AFMPS's guidance regarding direct-to-patient dispensing of medicinal products in clinical trials

Because of the COVID-19 and the related risk of hospital overload, it may be difficult or undesirable for a patient enrolled in a clinical trial to obtain the investigational medicinal product at the hospital. The AFMPS has developed guidelines providing that, if a patient cannot access the hospital, or if this is undesirable in the current circumstances, it is permitted to send investigational medicinal products directly to the patient. The related responsibility lies with the principal investigator. For reasons of confidentiality and integrity the clinical trial sponsor is not permitted to participate in this process. The appropriate shipping conditions must be respected. The process of supplying the medicinal product to the patient should be documented and fully traceable.

There are a number of issues that should be taken into account if a trial sponsor and the trial site chose to pursue this approach. Fundamental among these is the manner in which the medicinal product is administered to the patient and the potential consequences of a change in venue for the health of the patient. If administration is permitted solely by a health care professional then related procedures should be put in place to permit this in a home setting. If there is a possibility that the patient could administer the product themselves related support and guidance needs to be established.

The consequence of a change in place of administration of the medicinal product for conduct of the clinical trial and related results should also be considered. If the clinical trial protocol makes specific mention of the fact that the medicinal product must be administered in a hospital setting, the consequences of a change in setting to home for the trial outcome should be discussed with the relevant ethics committee.

Belgian Federal government sets up a Task Force to remedy the shortage of protective equipment and medical equipment on the Belgian market.

The objectives of the Belgian Federal government's Task Force are to identify problems and provide urgent measures in relation to the supply of priority products, such as face masks, personal protective equipment, diagnostic tests, and alcohol-based hand gels for health care professionals. The Task Force also intends to explore ways to solve shortage problems, for example by purchasing and confiscating existing stocks of face masks (medical and industrial) at wholesale and retail outlets or by introducing an immediate ban on the sale of facemasks without a doctor's prescription. This Task Force will immediately implement economic, logistical and legal actions and will propose solutions to support Belgian health care providers. In light of the fact that normal public procurement procedures may take too long in present circumstances, the Task Force is also considering implementation of "outside the box" solutions.

AFMPS takes measures to ensure continuity of treatment for patients suffering from chronic diseases

The AFMPS is closely monitoring the stocks of medicinal products used in the fight against COVID-19. This is, among other reasons, because some of these medicinal products are essential for treating patients with chronic diseases such as lupus, rheumatoid arthritis or HIV. The AFMP is taking measures to guarantee the availability of these essential medicinal products to patients with these chronic diseases.

In order to guarantee the treatment of chronically ill patients, the AFMPS has quarantined all stocks of Plaquenil, chloroquine phosphate and Kaletra at wholesalers, wholesaler-distributors and pharmaceutical companies. Pharmacies open to the public will only be supplied with stocks of these products sufficient to meet medical prescriptions within the framework of the authorised indications for these chronic patients and not for COVID-19.

For the treatment of COVID-19, the Belgian Health Institute, Sciensano, has recommended that general practitioners limit the prescription of these essential medicinal products to hospitals treating patients severely affected by COVID -19.

All the guidance documents are available on the AFMPS website.



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