What is a side effect?
A side effect is a harmful adverse reaction to a medicine. Side effects may occur in case of:
- normal use of a medicine as written in the patient information leaflet;
- improper use of a medicine: intentional incorrect use of a medicine inconsistent with the patient information leaflet;
- abuse: persisting or sporadic intentional excessive use of a medicine associated with harmful physical or psychological effects;
- a medication error: unintentional treatment error with a medicine, harming or potentially harming the patient. Medication errors are, for example, prescription errors, dispensing errors, storing errors or errors in preparation and administration of a medicine;
- professional exposure: exposure to or contact with a medicine while executing a profession.
What is pharmacovigilance?
Pharmacovigilance protects public health by monitoring medicines’ safety and ensuring the benefits/advantages of taking a medicine outweigh its risks.
The authorities responsible for pharmacovigilance collect and evaluate data on medicine side effects and take measures if necessary.
Why is reporting side effects important?
Before a medicine is brought to market, it has been extensively tested in scientific research to prove its safety, quality and efficacy. The last phase of this scientific research consists of clinical trials in a relatively small number of healthy volunteers and patients. These trials are performed under controlled conditions for a relatively short period of time. During the various phases of their scientific research, investigators identify frequently occurring and predictable side effects.
Once a medicine is for sale, millions of patients are using it in everyday life and no longer under the scientific research test conditions. Patients belonging to various age groups, sometimes having different conditions, are also taking other medicines and have various lifestyles. Because of this, some rare side effects might come to light. Some side effects only occur if someone uses the medicine for a long period of time. Other side effects might only show when patients stop taking the medicine.
Therefore it is important to further monitor medicines’ safety of after they are brought to market. And that is only possible if patients, medicine manufacturers and health care providers report side effects to the competent pharmacovigilance authority. In Belgium this is the Federal Agency for Medicines and Health Products (FAMHP).
How can report a side effect to the FAMHP?
Are you or someone you know suffering from side effects? If so, contact your doctor or pharmacist. In some cases he or she will adjust the treatment.
Your doctor or pharmacist can report a side effect to the FAMHP for you. You can also easily report side effects of medications yourself online to the FAMHP.
Is the application for reporting side effects not working?
You can also report side effects using the paper report form. You can request a paper copy of the report form at ADR@fagg.be.
What does the FAMHP do with my side effect report?
A group of scientific experts at the FAMHP analyses every report of a side effect and identifies new information about medicines. If necessary, the FAMHP takes corrective action to protect public health to ensure a medicine’s benefits outweigh its risks.
All side effect reports are also (anonymously) collected on a European level. Data from your report are processed together with similar data from other European Union member states. Thanks to this large-scale collaboration, all EU member states can take equivalent corrective action if necessary.
The FAMHP, usually in cooperation with the European Medicines Agency (EMA), can decide to revise a medicine’s patient information leaflet. Possible revisions are adding a new side effect or a warning to the patient information leaflet or changes in guidelines for using the medicine.
If using a certain medicine appears to have more risks than benefits, the FAMHP can temporarily suspend its marketing authorisation (MA) while awaiting further research. A temporary suspension may lead to a definitive revocation of the MA.
If the report shows there is a problem with the quality of the medicine, the FAMHP can investigate this. If the investigation shows the quality is not compliant, the FAMHP can have affected batches taken off the market.
The FAMHP communicates significant problems with medicines’ safety in announcements on its website and/or sends letters in which it describes the actions taken to the affected health care professionals.
Will the FAMHP send my report to the pharmaceutical company responsible for the medicine?
The FAMHP transfers all reported side effects anonymously (without your personal information) to EudraVigilance, the European medicine surveillance database. Pharmaceutical companies have got access to this database and can consult reports on their medicines.
Can I report any side effect of a medicine to the FAMHP?
You can report any side effect of a medicine you or someone you know suffer from to the FAMHP.
Always report these side effects:
- serious side effects that have led to:
- a life-threatening situation or death;
- a hospital admission or extended hospital stay;
- an impact on daily activities (e.g. temporary inability to work, not being able to leave the house);
- a congenital deformity;
- another medically significant event.
- new and unexpected side effects: side effects whose type, severity and/or evolution is not consistent with the patient information leaflet;
- side effects in children and other vulnerable population groups such as pregnant women, woman who are breast-feeding and the elderly;
- suspicious side effects: known side effects whose frequency, severity or outcome is abnormal;
- side effects of vaccines;
- side effects when switching from one medicine to another;
- side effects caused by professional exposure to a medicine: exposure to/contact with a medicine while executing a profession ;
- side effects of a medicine under additional monitoring, indicated with the symbol ▼. The FAMHP and the EMA publish lists of medicines under additional monitoring in Belgium and in Europe.
Where can I turn to if I’ve got questions that are not answered in this question and answer document?
You can pose any additional questions
- in an e-mail to ADR@fagg.be
- by letter to
Federal Agency for Medicines and Health Products
Vigilance Division
Eurostation II
Victor Hortaplein 40/40
1060 BRUSSELS