Who is involved in pharmacovigilance?

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This detailed monitoring of any incidents that the product may cause allows for the modification of information regarding recommendations for use, modification of information contained in side effects and allows the drug to be withdrawn from the market if necessary. This therefore guarantees patient safety.

It is everyone's responsibility . It is a shared responsibility of health authorities, the pharmaceutical industry, healthcare professionals and citizens themselves. Its success depends on the collaboration of all the parties involved.

The Spanish Pharmacovigilance System was created in response to the need to monitor potential problems related to the use of medicines. In Spain, the old Medicines Law of 1990 already included the importance of health professionals participating in the protection of health, but it was not until 2002 when it was regulated by law (RD 711/2002, of July 19). Currently, this RD 711/2002 has been repealed and replaced by Royal Decree 577/2013, of July 26, which regulates the pharmacovigilance of medicines for human use .

Doctors, pharmacists, nurses and other health professionals are required to report any suspected adverse reaction to medications and send it urgently to the corresponding Regional Pharmacovigilance Centre.

Following notification, the Agency's tunisia phone data technical committee for pharmacovigilance assesses the importance of the reaction and adopts appropriate measures, which may include temporary or permanent withdrawal of the drug and, of course, informs all health care agents involved.

Although it is the competent authorities that must report and act in the event of discovering a possible adverse reaction, patients must also notify their doctor or pharmacist of any reaction apparently related to a medicine they are taking, in order to actively contribute to the safety of everyone.

Pharmacovigilance guarantees the safety of a medicine , since it ensures that the adverse effect detected has a much lower incidence than the benefit of its administration.