Questions and answers regarding reporting adverse reactions

Each drug is thoroughly tested in clinical trials before being marketed. However, some adverse reactions are only observed after the drug is on the market, once it has been used by a large number of people over time. 
If you experience an adverse reaction while taking a medicine, report it to www.famhp.be/en/side_effect.  
Reporting adverse reactions helps us provide more information about our medicines. This information can help people recognise undesirable effects in good time and avoid them. It can also influence the decision to prescribe/recommend a particular drug. Your contribution is important to improving drug safety.
 

 

Any suspected adverse reaction can be reported to www.famhp.be/en/side_effect.
Please note that it is important to report any adverse reactions that may result in:  

• hospitalisation or an extension of hospitalisation;
• a danger to life;
• death;
• lasting or significant disability or incapacity;
• a congenital anomaly or malformation;
• any other medically significant event.

Are you not sure whether the medicine is responsible for the adverse reaction? Or is it already listed in the leaflet, but you are worried about its severity or unusual development? Please notify us at www.famhp.be/en/side_effect.

Pay attention to adverse reactions to medicine under additional supervision. They can be identified by an inverted black triangle "▼" on their leaflets.
 

 

An adverse reaction is a harmful and unintended response to a medicine. You cannot always be sure that what you are experiencing is medicine-related, but by reporting suspected adverse reactions, you can help the authorities in their investigations and help improve drug safety.

 

Anyone who experiences an adverse reaction can report it. Family or friends can also do this, for example for a child. Healthcare professionals such as doctors, pharmacists and nurses can report adverse reactions experienced by their patients. The www.famhp.be/en/side_effect website contains different forms to be completed by patients and healthcare professionals.

 

The www.famhp.be/en/side_effect website helps you to provide all the relevant information, such as: 

• information on the person who experienced the adverse reaction* (this data is processed in compliance with the GDPR); 
• a description of the adverse reaction*; 
• the name of the suspected medicine*; 
• the dosage and frequency of use of the medicine (posology);
• the batch number on the medicine packaging (if available);
• the dates, even approximate, when the drug was taken and when the adverse reaction occurred; 
• any other medicine taken at the same time; 
• any other health problem;
• the evolution of the adverse reaction*;

*These fields are mandatory.
 

 

When an adverse reaction occurs, it is logical to suspect the "last" medicine(s) taken. But the medicines or dietary supplements you are taking at the same time may interact with this "last" medicine(s). Please contact your pharmacist or doctor if you have any questions about your treatment. Do not stop taking your medicine without medical advice.

 

Some adverse reactions are known to appear quickly after the medicine is taken, while others take longer to appear (weeks, even months). Similarly, some adverse reactions disappear rapidly once the medicine is stopped. Others take longer to disappear and/or require specific treatment. All this information will be used by experts to assess the causal link between the suspected medicine and the adverse reaction. Lastly, if the adverse effects tend to disappear after the medicine is stopped and reappear when taken again, this is also important information for assessing causality.

 

Your notification is individually assessed and encoded in international pharmacovigilance databases in compliance with GDPR rules. The FAMHP will contact you if important information is missing from your notification. Drug safety experts then review your notification, along with other medicine reports, to see if any new information is available (called a "signal"). After evaluating the signal and any other relevant data, health authorities may issue new warnings or advice on how to use the medicine, and may even decide to discontinue its use.

 

These measures vary according to the nature, severity and frequency of the adverse reaction, as well as the intended use of the medicine, the benefits obtained from its use versus the risks, and the availability of alternative treatments. Possible regulatory measures are:

• conducting post-authorisation studies to obtain additional information on the medicine's safety profile;
• carrying out a complete reassessment of the benefit/risk profile;
• modifying the drug information;
• changing the packaging to clearly identify the risks and revise the instructions for use;
• disseminating information on risks to healthcare professionals and patients (through letters, advice, publications and specialised websites);
• withdrawing the drug from the market.
   

 

The known adverse reactions associated with a drug are described in the package insert and in the summary of product characteristics (SPC). They can be found on the medicines database.

 

All personal information linked to the notification of an adverse reaction is processed in accordance with EU legislation on the protection of personal data. Your notification is used only for the scientific evaluation of the medicine. See our privacy statement.

 

The inverted black triangle "▼" indicates that a medicine is under additional monitoring either because it is new, or because information on its long-term use is limited. It serves as a reminder to report any suspected adverse reaction. This symbol does not mean that your medicine is dangerous. 

 

 

Educational material, known as "RMA" material (Risk Minimisation Activities) and designated by the logo  is available for certain medicines to minimise the risks associated with their use. 

Examples: 

• checklist for prescribers;
• card to be kept by the patient. 

In general, the patient receives the "RMA" material when the medicine is prescribed or when it is dispensed by the pharmacist.
Find the "RMA" material for a drug on the medicines database. After searching for a medicine, click on "RMA" in the "Downloads" column. 
Please note that the information contained in "RMA" material is limited. Consult the information on a medicine in the leaflet and the summary of product characteristics (SPC) on the medicines database.

Reporting a medication error 
A medication error is an unintentional failure in the medicine treatment process that can result in harm to the patient. They are most often errors in prescribing, dispensing, storing, preparing and administering a medicine.
Be careful not to confuse medication errors with medical errors. Medication errors concern the medicine itself, whereas medical errors concern the medical act performed.
The purpose of reporting a medication error is to assess the cause of the error and, if possible, ways to prevent this error from recurring.
It is important to report all medication errors, whether or not they resulted in an adverse reaction. Your contribution is invaluable to public health.

• Error with no adverse reaction: contact medication-errors@afmps.be.
• Error with adverse reaction: notify www.famhp.be/en/side_effect.

Reporting medicine abuse or misuse
Reporting medicine abuse or misuse is not intended to punish the person in question, but to prevent any recurrence. Reports enable the FAMHP to take risk reduction measures such as providing information to patients or healthcare professionals or adapting the package leaflet. Your contribution is crucial to public health.

• Abuse or misuse with no adverse reactions: contact ADR@afmps.be.
• Abuse or misuse with adverse reaction: report it to www.famhp.be/en/side_effect.