Pharmacovigilance is the science and activities related with the detection, evaluation, understanding and prevention of adverse events or any problem related to medicines and health products. The key concept of this activity is the adverse reaction, which means any harmful and unintended reaction that occurs after the administration of a medicine or health product. Historically, Pharmacovigilance began its development in 1961 with the thalidomide disaster, being this the major starting point for the development of an international system, by the World Health Organization, that aimed to collect information on adverse reactions and improve the safety profile of medicines (WHO Pilot Research Project for International Drug Monitoring). In 1992, with the creation of the National Pharmacovigilance Center, Portugal started to participate in this system.
- Monitor the safety profile of medicines and health products
- Constantly evaluate the risk-benefit ratio of medicines and health products
- Minimize risks and maximize benefits
- Transmission of information on the safety of medicines and health products
- Protection of Patients and Public Health
In order to harmonize and provide adverse reaction reports as complete as possible, there are four minimum criteria necessary for a report to be considered valid:
AN IDENTIFIABLE PATIENT (initials, gender, age or age range and date of birth);
A SUSPECTED DRUG;
AN ADVERSE REACTION;
A REPORTER (name and contacts of the consumer, family member, or health professional).
Medicines and health products are extensively studied and tested prior to their commercialization. However, not all situations to which the medicines and health products will be exposed, after their commercialization, can be anticipated. Thus, in addition to the concept of adverse reaction, there are special situations that must also be collected and reported, even if not associated with an adverse reaction. Please consider the following special situations:
Exposure during pregnancy
Exposure during breastfeeding
Inadvertent or accidental exposure
Lack of drug effect
Suspected transmission of infectious agents
If you can not gather the four minimum criteria, you should still report the information you have available.
Pharmacovigilance is an extensively regulated area and mandatory for companies within our scope. However, the collaboration of all stakeholders in the health process (health professionals, consumers, pharmaceutical industry and authorities) is crucial to increasing knowledge about marketed products, thus contributing to their safety, efficacy and quality.
Se pretender notificar uma reação adversa, consulte o separador ‘Contactos’, e preencha o formulário de contacto disponibilizado.