What is Pharmacovigilance?

Pharmacovigilance is the range of activities contributing towards the protection of public health. They are aimed at identifying, evaluating understanding and preventing the adverse effects or any other problem linked to the use of drugs, to ensure a favourable benefit-to-risk ratio for the population. Pharmacovigilance is a legally required activity envisaged by both Italian and international healthcare authorities.

The purpose of Pharmacovigilance is therefore that of providing, on a continuous basis, the best possible information on the safety of drugs, thus enabling the adoption of appropriate measures.

Pharmacovigilance has four main aims:

  • to recognise as rapidly as possible any adverse reaction to drugs (Adverse Drug Reaction);
  • to improve and increase information about suspected or already known ADRs;
  • to evaluate the advantages of one drug compared with others or with therapies of different types;
  • to communicate the information to the Health Authorities so as to improve therapeutic practice.

How to report an Adverse Drug Reaction and to whom

Spontaneous reporting by patients, doctors and chemists, and by anyone to whose knowledge an adverse reaction comes, is therefore essential in order to enable the effectiveness and safety profiles of drugs in their actual conditions of use to be defined and kept up to date.

To report an undesired effect occurring with the use of a MASTELLI drug:

A) complete a “hardcopy report of a suspected Adverse Drug Reaction” (introduced with Ministry Decree dated 12/12/2003), available on the AIFA site. The report can be downloaded and printed by clicking on the dedicated link for the public or healthcare professionals, depending on who is making it. The completed report has to be forwarded to the person in charge of Pharmacovigilance care of the healthcare facility for the district involved;

B) or, complete on line the “electronic report of a suspected adverse reaction (https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse) by clicking on the dedicated link for the public or healthcare professionals. After completing the report on line, it can be saved on one’s PC and sent by e-mail to the Head of Pharmacovigilance of the facility concerned. As an alternative, the on-line form can be printed, filled in and sent to the Head of Pharmacovigilance of the facility to which one belongs (in the manner described under point A above).

Reports

As an alternative, it is possible to report directly to the company MASTELLI at the following addresses:

phone: +39 01845111

cellphone: +39-3485146006 (Dr Paolo Biffignandi, Head of Pharmacovigilance and EU QPPV at MASTELLI s.r.l.)

email: farmacovigilanza@mastelli.com or pharmacovigilance@virelpharma.it