PharmaStatus: a new online application on the availability of medicines

In recent years, the Federal Agency for Medicines and Health Products (FAMHP) invested in a multi-faceted approach to the problem of unavailable medicines with both actions on the terrain as legislative initiatives. The most recent development is the online application PharmaStatus.

A multi-faceted application

Patients can search whether their medecine is available and can register to keep informed of the availability of a specific medicine by e-mail. The application also provides information about the reason for the unavailability and the impact of it. Extra recommendations are also provided for critical unavailabilites as well as alternatives and priority indications.

Pharmacists and full-line wholesalers can contact the marketing authorisation holder of a drug or parallel importer directly via the application if they suspect that a drug is unavailable. The FAMHP can follow these notifications and thus have a better view of the real life situation.

Marketing authorisation holders and parallel importers are obligated to report changes in the availability of drugs. This is now very easy using the application. The marketing authorisation holder can also follow up and answer or reject complaints or questions from a pharmacist or wholesaler-distributor and take the necessary actions when needed.

With this application, the FAMHP is providing streamlined communication between the government and all parties involved.

Information on the unavailibility of all authorised medicines

PharmaStatus shows information about all of the medicines authorised in Belgium that are temporarily unavailable or for which commercialisation is being stopped temporarily or definitively. This includes medicines for human as well as veterinary use. When medicines become available again, this is shown in the application.

The advantages of PharmaStatus

• Current information

PharmaStatus is updated daily. Information about changes in availability of a medicine is thus a maximum of one day old. A newly licensed medicine is visible in the application one week after being licensed.

• Complete information

The start date, expected end date or extension of the unavailability is displayed. The reasons for the unavailability and the impact of it are listed. Via the application, the package insert or SmPC (Summary of Product Characteristics) can also be queried. The FAMHP can also provide extra information such as alternatives or the recommendations from the Task Force on unavailabilities for critical lack of inventory.

• Linked to other applications

PharmaStatus is linked to the national drug database (SAMv2) which is used as a source of information for numerous other applications such as the electronic medicines prescription (required from January 1, 2020). When prescribing, a doctor will, for example, already be able to see whether a medicine is temporarily unavailable.

• Simplified administration

Currently, the reports are made via forms available on the website, after which the information is entered manually into the FAMHP database. The current method is time-consuming for all parties involved. PharmaStatus streamlines the process.

• User friendly

To improve the quality of the information published, user-friendliness of the application was one of the priorities.

Various phases and other actions

In the first phase of PharmaStatus, all functionalities are ready for marketing authorisation holders and patients. In a second phase, planned for the beginning of next year, all functionalities will be available for pharmacists and full-line wholesalers.

The FAMHP will continue to work on solutions to prevent unavailability of medicines: extra resources to intensively follow up on reports of unavailability, new legislative initiatives and analyses of every unavailability following a decision tree. Considering that this is a worldwide problem, there is systemic consultation and information exchange on a European level to find joint solutions. It is clear that in addition to the government, all parties involved, such as the pharmaceutical industry, wholesalers and distributors and healthcare professionals must make further efforts to limit the impact of unavailable medicines for the patient.

More information
www.pharmastatus.be