Login

Access type

Forgot your password? Click here

LOGIN
Annulla
Forgot
DMP_ForgotOK Close

REGISTER

If you are a doctor or a journalist not yet registered at the Dompé reserved areas, click here to fill in the form.

REGISTER
A A A
Contacts
Follow LinkedIn YouTube

www.dompe.com

Pharmacovigilance

To contact Dompé pharmacovigilance please fill in the form

Email* Subject Phone number Drug* Description
Captcha *
 
Privacy Policy*

I have read the privacy policy and consent to the processing of personal data.

*The compilation of these fields is mandatory.

SEND

Pharmacovigilance is a key factor in the development and use of a drug, and consists of all of the activities aimed at collecting and continuously assessing information about drug safety, including suspected adverse reactions. On the basis of continuous reviews of the safety profiles of medicinal products, pharmacovigilance implements appropriate precautionary measures in order to ensure that, when used as authorised, marketed drugs have a risk/benefit ratio that is favourable for the population involved. In this sense, it is an essential means of improving our knowledge of drugs, providing correct information for the physicians who prescribe them, and protecting the patients who take them. Drug safety is guaranteed by close collaboration between all of the healthcare personnel involved, national and international health authorities, and pharmaceutical companies.

 

For Dompé Group, the final aim of pharmacovigilance is to assess a drug’s tolerability profile constantly throughout the period of its use, from the first clinical trials to the end of the post-marketing phase.

What is an adverse reaction?

An adverse reaction is any unwanted and harmful effect of a medicinal product due to:

  • its use as indicated in its marketing authorisation;
  • therapeutic errors;
  • uses other than those indicated in the marketing authorisation, including over-dosage, improper use, and abuse;
  • drug exposure for professional reasons.

What to do in the case of a presumed adverse drug reaction

Suspected adverse drug reactions can be spontaneously reported by both healthcare workers and the general public using special forms provided by the Ministry of Health, which should be sent to the pharmacovigilance personnel of the local health authorities, hospitals or other healthcare facilities.
All of these reports are entered by the competent local health authorities in the national adverse drug reaction database called the “National Pharmacovigilance Network”, which is managed by the Italian Medicines Agency (AIFA).
Like the other Member States of the EU, Italy is part of the European system of pharmacovigilance, and acts in accordance with the methods agreed at community level and defined by the European Medicines Agency (EMA).

Patients

Reports are to be made using the “Form for the communication of undesired effects by members of the public”, which can be downloaded from the AIFA website using the link http://www.agenziafarmaco.gov.it/sites/default/files/tipo_file07d6.pdf

Once completed and signed, the form has to be sent to the Head of Pharmacovigilance of the hospital or local health authority to which the person making the report belongs. An updated list of these people can be found using the link http://www.agenziafarmaco.gov.it/it/responsabili

Healthcare professionals

Reports are to be made using the “Form for reporting a suspected adverse reaction”, which can be downloaded from the AIFA website at this address:
http://www.agenziafarmaco.gov.it/sites/default/files/tipo_filecb84.pdf
Once completed and signed, the form has to be sent to the Head of Pharmacovigilance of the hospital or local health authority to which the person making the report belongs. An updated list of these people can be found using the link http://www.agenziafarmaco.gov.it/it/responsabili

For further information about pharmacovigilance

http://www.agenziafarmaco.gov.it/
http://www.ema.europa.eu/ema