The session dedicated to pharmacovigilance “The new horizons of pharmacovigilance in Italy and Europe” of the 58th AFI Symposium held on Friday afternoon, had as main themes the news and the criticalities of the application of the new European ICH E2B R3 legislation. Mrs. Sottosanti intervened making particular reference to the pharmacovigilance activities with the relative novelties, critical issues and possible solutions with reference to the regulatory obligations.
Mrs. Sottosanti of AIFA, who spoke after the intervention of Mr. Porcelli, immediately wanted to underline how the last years have been particularly important for pharmacovigilance since they have brought an organized, proactive and proportionate approach to risk essential for patient and public health protection.
In support of these improvements, the European Medicines Agency (EMA) implemented the New EudraVigilance System on 22 November 2017. Now that all data is in a single European database, it is expected that it is able to support large volumes of users and data, to provides greater transparency in access to all information regarding the patient and the patient. health worker and to create a greater collaboration with EMA and the WHO Uppsala Monitoring Center (UMC).
Consider that EudraVigilance holds more than 12 million reports relating to almost 8 million cases and over 740 thousand medicinal products. Almost 1.5 million new cases were introduced in 2017, of which over 540 thousand (37%) originated in the EEA with an increase of 19% on the total and 60% for only the EEA data compared to 2016. This increase is linked to an average monthly increase in cases and to the new reporting system, even in non-serious cases introduced by the new rules starting from November 2017. Italy is the fourth country for the number of sent cases after Germany, France and the UK. The total number of reports entered directly by European patients has increased significantly in 2017, exceeding 90,000 cases, almost twice as much as in 2016.
Mrs. Sottosanti admitted that integration with the European database was not smooth. Adaptation difficulties have been encountered due to the fact that the Italian system is based on the figure of the pharmacovigilance manager of the regional public structures, while the European system is focused on pharmaceutical companies and that Italian companies initially had to integrate the cases downloaded by EV with the additional information contained in the Italian central database. Fortunately, this last problem has been solved as this information is regularly transmitted to EV since 15 May 2018. In addition, EudraVigilance already works in the ICH E2B R3 format, while the Italian central database is still in R2. Please note that in EudraVigilance today are registered 5,476 MAHs for 18,970 users and 78 NCAs for 1,256 users, but of these only 49 MAHs and 9 NCAs send data in R3 format with gateway, while all others continue to use R2 format with gateway or EVWEB.
The speaker concluded by explaining what the next developments will be:
- New Italian National Network of Pharmacovigilance in ICH E2B (R3) format from the end of 2018
- Update of the report form of suspected adverse event
- Courses for pharmacovigilance responsible and Regional Centres for Pharmacovigilance
- Strengthening of signal management activities
- Optimization of independent studies of active pharmacovigilance.