Medicines have been developed and used for centuries but it was only in the 1960’s that it was deemed necessary to closely control the quality, efficacy and safety of medicines before making them available to patients. Pharmacovigilance has a role in this context.
Before a medicine is marketed, extensive clinical studies are conducted. Nevertheless, these studies have limitations due to the strict and standardized conditions in which they are conducted.
Once the medicine is marketed, it is used by a more heterogeneous population (e.g. patients with important comorbidity or patients taking other medicines, children or elderly people), in other circumstances than the ones of the clinical study, sometimes by millions of patients and during years.
Some rare adverse effects or adverse effects that occur late are often only detected at that moment. For this reason, it is necessary to report adverse effects to the Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH) once a medicine is marketed and used under real circumstances.
At the beginning of the 60’s it became apparent that the medicine Softenon® (thalidomide) was causing congenital disorders (resulting in shortened or missing limbs) among children whose mothers had used the medicine during pregnancy. This led to a global awareness that medicines can produce unexpected adverse effects.
In 1968 the World Health Organization established an international pharmacovigilance-program that has been executed since 1978 by the international centre for pharmacovigilance that centralizes data about adverse effects collected by national pharmacovigilance centres.
The BCPH started its activities in 1976 after being recognized by the WHO. Since then the BCPH has been centralizing all reports of adverse effects concerning authorized medicines.
Healthcare professionals (doctors, pharmacists and dentists) can report their concerns or findings about the safety of medicines at the BCPH by using the « yellow card ».
In December 2010 the BCPH has made available an electronic tool for the online reporting of adverse effects for the healthcare professionals, accessible via www.fichejaune.be (in French). Click here for more information (in French).
The paper version of the yellow card can be printed and sent by post to the address mentioned at the back of the yellow card (postage paid by the recipient). The “paper yellow card” is also available in the “Répertoire Commenté des Médicaments” and three times a year via the Folia Pharmacotherapeutica. In case you wish to receive a paper reporting form, you can request this at any time via the email address: email@example.com
It was also necessary to oblige pharmaceutical companies to organize themselves in order to continue to follow up the medicines once marketed. But how?
Until the mid 90’s there was no specific legislation about pharmacovigilance. Based on the European directives, specific obligations were imposed to the marketing authorization holders (= MAH) of medicines for human use but also to the authorities in the EU Member States:
- Authorization holders have to designate a person responsible for pharmacovigilance.
- Authorization holders must register and keep detailed reports of all presumed adverse effects that occurred both inside and outside the European Union. They must also transfer some of those reports to the BCPH in a predetermined timeframe.
- At regular intervals authorization holders must submit to the BCPH periodic safety update reports (periodic pharmacovigilance reports).
- Member States must develop a pharmacovigilance system and take the required measures to encourage doctors and other healthcare professionals to report adverse effects through this system.
- European pharmacovigilance must ensure an exchange of information about pharmacovigilance between Member States and pharmaceutical companies.
What is pharmacovigilance?
Pharmacovigilance can be described as the sum of techniques for the evaluation of the risk of occurrence of adverse effects with medicines after being marketed.
The objectives of pharmacovigilance are:
- Early detection of unknown or insufficiently documented adverse effects and interactions.
- Detection of an increase of the frequency of a known adverse effect.
- Identification of risk factors and mechanisms that are at the basis of the occurrence of adverse effects.
- Continuous reevaluation of the risk-benefit balance of medicines.
- Distribution of information about adverse effects and interactions so that they occur less frequently and in order to have less therapeutic errors.
What is the objective of pharmacovigilance?
The ultimate objective of pharmacovigilance is to guarantee patient protection.
What is an adverse effect?
An adverse effect is a response to a drug that is noxious and unintended, and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the recovery, correction or modification of physiological function.
What is a serious adverse effect?
A serious adverse effect is an adverse effect that has lead to hospitalization or prolongation of the hospitalization, that has been life-threatening, or that has caused death, permanent or significant disability or inability to work, or congenital disorder or malformation.