Pharmacovigilance

Pharmacovigilance encompasses all of the practices which aim to continuously provide the best possible information concerning drug safety. This way, all of the necessary steps can be taken towards ensuring that the population benefits from marketed medicines which offer a favourable benefit-risk balance within their authorised conditions of use.

The 4 main objectives of Pharmacovigilance are the following:

  1. Diagnosing new Adverse Drug Reactions (ADR) to drugs as soon as possible
  2. Improving and expanding all information concerning both suspected and known ADR
  3. Evaluating the benefits of a given drug over others or over other forms of therapy
  4. Circulating information so as to improve therapeutic practices

Therefore, spontaneous reporting by doctors and pharmacists is essential in ensuring that Pharmacovigilance authorities can define and update safety and tolerability profiles of medicines (benefits vs. risks) in their real conditions of use.
Pharmacovigilance is a mandatory practice according to Italian and international health authorities.

Reporting an adverse reaction: How and to whom?

On various levels, the entire community is involved in Pharmacovigilance practices: patients, prescribing physicians, healthcare professionals, pharmaceutical companies, institutions and academia. Adverse events can be reported both by health professionals and citizens.
To report an adverse event experienced after using a MASTELLI product:
A) Please fill out the form “scheda cartacea di segnalazione di sospetta reazione avversa” (paper reporting form for suspected adverse reaction) (established by Ministerial Decree 12/12/2003) which can be found on the AIFA website. Said form can be downloaded and printed by clicking on one of two links – one for citizens and one for healthcare professionals- depending on who is reporting. Once filled out, the form is sent to the local Pharmacovigilance authorities of the competent healthcare facility;
B) Otherwise, fill out the “scheda elettronica di segnalazione di sospetta reazione avversa form (digital reporting form for suspected adverse reaction) (http://www.agenziafarmaco.gov.it/it/content/modalit%C3%A0-di-segnalazione-delle-sospette-reazioni-avverse-ai-medicinali) by clicking on the citizens or on the healthcare professionals link. After completing the form online, it can be saved onto your PC and sent via e-mail to Pharmacovigilance authorities at the relevant healthcare facility. Alternatively, the online form can be printed, filled out and sent to the Pharmacovigilance authorities of your own healthcare facility (by following the procedure described in point A).

Contact details

It is also possible to report directly to MASTELLI S.R.L. via the following contact details:

Telephone: +39 0184 51090
Cell. Phone: +39 348 5146006
email: farmacovigilanza@mastelli.com

Pharmacovigilance authority and EU QPPV for MASTELLI: Dr Paolo Biffignandi

email: pharmacovigilance@virelpharma.it