A response to a medicinal product which is noxious and unintended, including:
• uses within the terms of the marketing authorisation.
• uses outside the terms of the marketing authorisation: off-label use, overdose, misuse, abuse and medication errors, as well as associated with exposure for professional reasons.
Whenever an adverse reaction or side effect occurs during therapy, it should be promptly reported to a doctor or pharmacist.
Every citizen can report a suspected adverse reaction through an appropriate "Template form for citizens reporting side effects", which can be downloaded from the website of the Agenzia Italiana del Farmaco - Italian Medicines Agency (AIFA) at the following address: http://www.agenziafarmaco.gov.it/sites/default/files/tipo_file07d6.pdf
For health professionals
Health professionals can report a suspected adverse reaction through the "Reporting of suspected adverse reaction form" which can be downloaded from the website of the Agenzia Italiana del Farmaco - Italian Medicines Agency (AIFA) to this address: http://www.agenziafarmaco.gov.it/sites/default/files/tipo_filecb84.pdf
The filled out form should be sent to the Head of Pharmacovigilance of local health centre you belong to.
The complete list of Head of Pharmacovigilance of the different health facilities, divided by region, is available at the following address: http://www.agenziafarmaco.gov.it/it/responsabili.
to find out more ...
Spontaneous reports of adverse reactions to drugs (ADRs) that occur in Italy are collected by the National Network of Pharmacovigilance - Rete Nazionale di Farmacovigilanza - (RNF), promoted and managed by AIFA (Italian Medicines Agency).
In addition, Italy with all other member states is part of a European Pharmacovigilance system and operates in accordance with European legislation established by the European Medicines Agency (EMA).
AIFA, with its website, provides constant updates regarding Pharmacovigilance: http://www.agenziafarmaco.gov.it/it/content/la-sicurezza-dei-farmaci
SIFI S.p.A. Pharmacovigiliance Service
Tel.: +39 095 7922204 - +39 095 7922356
Fax: +39 095 789 34 51
Vigilance of medical devices
The DispoVigilance for medical devices is a System for the collection of alerts that occur with the use of a medical device aimed at improving the health and safety of users, reducing the probability of occurrence of the same type of Incident.
An instrument, a device, a system, a substance or other, used alone or in combination, including the software necessary for the proper functioning, intended by the manufacturer to be used on people for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of a disease,
• diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process
• intervention on conception,
provided they do not perform its principal action in or on the human body, to which it is intended, by pharmacological immunological means, nor through metabolic process, but whose function may be assisted by such means.
a) any malfunction or change in the characteristics and performance of a medical device, as well as any inadequacy in the labelling or the instructions of use that may be or have been the cause of death or serious deterioration of the health conditions of a patient or a user;
b) any technical or medical reason in relation to the characteristics or performances of a medical device that, for the reasons referred to in point (a), leads to the systematic recall of devices of the same type by the manufacturer.
The public and private health care providers can report an incident occurring with a medical device through the "Incident report by healthcare professionals by the Ministry of Health" available at the following address: http://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/
Health care professionals are invited to submit the same informing SIFI SpA as well through the form available at the following address: http://www.salute.gov.it/imgs/C_17_pagineAree_26_listaFile_itemName_3_file.pdf
The Ministry of Health has the duty to assess and record the data related to incidents with medical devices. With its website, it also offers to the Citizen, constant updates regarding DispoVigilance for medical devices.
All Member States will then add the collected data to the centralised european database - European Database for Medical Devices (EUDAMED) - in order to improve knowledge on the use of these products.
SIFI S.p.A. monitoring device Contact Service
Tel.: +39 095 79 22 500 - +39 095 79 22 204
Fax: +39 095 79 22 240
Vigilance of Surgical devices
In accordance with the provisions of the Medical Device Vigilance Guideline (MEDDEV 2.12.1), SIFI MEDTECH actively runs a post-marketing monitoring system on its products. This activity is useful to verify customer's perceptions on the quality and performance characteristics of devices and ensures, through continuous monitoring, product safety.
SIFI MEDTECH Srl monitoring device Contact Service
Tel.: +39 095 79 22 820
Fax: +39 095 79 22 447