Pharmacovigilance: What is it? What is it for?

which, as will be seen below, can be done both by citizens and by doctors and health workers.

The so-called local pharmacovigilance managers are present in the various health facilities (local health authorities - ASL, hospitals - AO, hospitalization and scientific care institutes - IRCCS), as well as in pharmaceutical companies, there are so-called local pharmacovigilance managers.

At the level of each Italian region, on the other hand, there are regional pharmacovigilance managers and regional centers. Their task is to ensure continuous monitoring of reports of adverse drug reactions, ensuring the safety of medicines currently on the market. The list of such managers is available on the official AIFA website (www.aifa.gov.it), or can be consulted by clicking here.

European EudraVigilance System

The European system EudraVigilance is a European database, operational since 2001 and managed by the "European Medicines Agency (EMA), used to analyze and manage all reports of suspected adverse reactions to medicines - both authorized and studied in clinical trials - throughout the European Economic Area (EEA).

Reports of suspected adverse reactions can be submitted directly to EudraVigilance by both national regulatory authorities, pharmaceutical companies with marketing authorizations (MAs) of medicines and sponsors of clinical trials.

RAM system

The RAM system (Adverse Drug Reactions Report) allows you to view all the data relating to reports of suspected adverse reactions recorded starting from 2002. These data are organized by year of entry and are periodically updated on a quarterly basis.

The search can be carried out both by commercial name of the medicinal product and by active ingredient or by association of active ingredients indicated as suspect. With this last modality, therefore, it is possible to have the data of all the medicines containing the active ingredient (s) of interest.

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The Italian legislation (Decree of the Ministry of Health of 30 April 2015) reiterated the obligation to promptly report suspected adverse reactions, establishing precise time limits:

  • Reports of suspected adverse drug reactions should be reported within 2 days from the time the doctor or healthcare professional learns of their presence;
  • The reporting of suspected adverse reactions concerning biological medicines - including vaccines - on the other hand, must take place in a shorter time; in detail, within 36 hours.

Reports can be made:

  • By filling in the suspected adverse reaction report form and sending it to the pharmacovigilance manager of your own facility, indifferently, by fax or e-mail (the compilation can also be done online);
  • Online on the VigiFarmaco website following the guided procedure shown.

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The report can be made both by doctors and health professionals and by the citizens themselves (there are different forms and procedures depending on who makes the report).

If a citizen wishes to report a suspected adverse reaction but is unable, or is unable to follow the online procedure on VigiFarmaco or fill in the form, he can contact his doctor or pharmacist. These health professionals will take care of collecting all the relevant information and filling in the appropriate reporting form, or they will report directly from the VigiFarmaco website.

Once the report has been sent, the pharmacovigilance manager will take care of registering and / or validating it in the National Pharmacovigilance Network, in turn connected to the EudraVigilance system.

If desired, it is also possible to send the report to the Marketing Authorization Holder of the drug suspected of causing the adverse reaction.

Products based on medicinal plants, food supplements and medical devices

The reports of suspected adverse reactions can, indeed must, also be made following the assumption of products based on medicinal plants, food supplements and medical devices.

The reporting of suspected adverse reactions from products containing officinal herbs, herbal products, food supplements, masterful preparations containing herbs or natural products, homeopathic medicines or other products of natural origin can be made from the VigiErbe website (online system of Phytosurveillance ).

In case of doubt, the alternative of contacting your doctor or pharmacist is always valid.

As for the reports concerning medical devices, manufacturers and health workers must refer to what is reported on the official website of the Ministry of Health.

Ilaria Randi

Graduated in Pharmaceutical Chemistry and Technology, she took and passed the State Exam for the Qualification to the Profession of Pharmacist
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