health supervision
Pharmacovigilance is a key factor in the development and the use of a medicine. It includes all activities aimed at collecting and evaluating on a continuous basis information on drug safety, including suspected adverse reactions. Pharmacovigilance, through a continuous review of the safety profile of medicinal products, decides on implementation of appropriate precautionary measures, ensuring that marketable medicines present a favourable benefit-risk ratio for the population, under authorised conditions of use. In this sense, Pharmacovigilance is an essential activity for better knowledge of medicines, to properly inform doctors who prescribe them and to protect patients who are taking them, guaranteeing their safety over time through close collaboration between all professional practitioners involved, national and international health authorities, local health authorities and pharmaceutical companies.
For Zeta Farmaceutici Group, the ultimate goal of Pharmacovigilance activities is to continuously evaluate the drug tolerance profile throughout its period of use, starting from early clinical trials and throughout the post-marketing phase.
Pharmacovigilance is a key factor in the development and the use of a medicine. It includes all activities aimed at collecting and evaluating on a continuous basis information on drug safety, including suspected adverse reactions. Pharmacovigilance, through a continuous review of the safety profile of medicinal products, decides on implementation of appropriate precautionary measures, ensuring that marketable medicines present a favourable benefit-risk ratio for the population, under authorised conditions of use. In this sense, Pharmacovigilance is an essential activity for better knowledge of medicines, to properly inform doctors who prescribe them and to protect patients who are taking them, guaranteeing their safety over time through close collaboration between all professional practitioners involved, national and international health authorities, local health authorities and pharmaceutical companies.
For Zeta Farmaceutici Group, the ultimate goal of Pharmacovigilance activities is to continuously evaluate the drug tolerance profile throughout its period of use, starting from early clinical trials and throughout the post-marketing phase.
What is an adverse reaction?
An adverse reaction is a harmful and unwanted effect, following:
- use of a medicinal product in accordance with the information contained in the marketing authorisation,
- therapeutic errors,
- uses that do not comply with the information contained in the marketing authorisation, including overdose, misuse, abuse of the medicinal product and associated with exposure for professional reasons.
What to do in the event of a presumed adverse reaction to a medicine.
Spontaneous reporting of suspected adverse reactions can be carried out by both citizens and healthcare professionals, using the appropriate ministerial forms to be sent:
- to those responsible for pharmacovigilance in local healthcare, hospitals or nursing homes;
- to holders of marketing authorisations (as explained on the AIFA website);
- to those responsible for pharmacovigilance for the holders of marketing authorisations.
All these reports are input by the local health centre concerned into the national database of adverse medicine reactions, called the "National Network of Pharmacovigilance" managed by the Italian Medicines Agency (AIFA).
Like the other Member States, Italy is also included in a European Pharmacovigilance system and operates in accordance with the agreed Community-wide rules defined by the European Medicines Agency (EMA).
For patients.
Reports may be made using:
- the “Modello di scheda per la comunicazione di effetti indesiderati dal cittadino”, downloadable from the AIFA website at link http://www.agenziafarmaco.gov.it/sites/default/files/tipo_file07d6.pdf
Once completed and signed, the form should be sent to the Pharmacovigilance officer of the patient’s health centre. An updated list of pharmacovigilance officers for the various health centres, by region, is available on link http://www.agenziafarmaco.gov.it/it/responsabili
- Online:
a) on the AIFA website: http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse;
b) on the “Vigifarmaco” website, www.vigifarmaco.it
If any undesired effects are noticed, patients can also report them to their doctor or chemist.
For healthcare professionals.
Reports may be made using the appropriate “Scheda di segnalazione di sospetta reazione avversa” downloadable from the AIFA website at: http://www.agenziafarmaco.gov.it/sites/default/files/tipo_filecb84.pdf
Once completed and signed, the form should be sent to the pharmacovigilance officer of the person’s health centre. An updated list of pharmacovigilance officers for the various health centres, by region, is available on link http://www.agenziafarmaco.gov.it/it/responsabili
For more information on Pharmacovigilance
http://www.agenziafarmaco.gov.it/
http://www.ema.europa.eu/ema
Information in compliance with article 13 of the European Regulation on personal data processing (GDPR - Reg. (EU) 679/16)
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