The unsustainable success of spontaneous report
Once again this year the Italian Medicines Agency (AIFA) will publish the data of 2013 spontaneous reporting within the OsMed report, which will be presented during the summer. While waiting for this detailed report, let us analyse the situation on Focus Farmacovigilanza as we do every year.
Even if we exclude literature reports (which are almost 3,000), reports included in the National Network for Pharmacovigilance in 2013 were 41,000, equivalent to a rate of 685 reports per million of inhabitants.
The increase in respect to 2012 has been consistent (+41%), very high for drugs (+47%) and just slightly raised for vaccines (+0.2). Once again there are many positive considerations. We already remarked in the past the importance of pharmacovigilance project funded by AIFA. During the triennium 2010-2012, 139 regional projects plus 19 interregional projects have been funded in 19 Regions (for more details please visit http://www.agenziafarmaco.gov.it/sites/default/files/Rapporto_farmacovig...). In 2013, with the agreement between State and Regions 2010-11, the new funds have been allocated, but substantially decreased.
Table 1 summarises the reporting situation. The increase in reports is common to almost every Region, in particular in regard to drugs. Lombardy and Tuscany rank at the first places both for number of reports and for rate, which exceeds 1,300 reports for one million inhabitants. To notice, also, the high increase for the Veneto region.
The situation of vaccines, on the other hand, is more articulated. The consistent decrease in the number of reports in Lombardy and Tuscany, linked to the conclusion of an active project on HPV vaccine, is compensated by an increase in many other Regions.
Table 1 - The reporting situation
|Region||N. reports||Rate per million||Difference with 2012|
Total Drugs Vaccines
|Friuli Venezia- Giulia||618||505.8||70%||77%||34%|
|Autonomous Province of Bolzano||105||206.0||-12%||-26%||23%|
|Autonomous Province of Trento||115||216.9||-31%||-36%||-20%|
Among the first ones worldwide
In total, the reporting rate in Italy in 2013 is 685 reports for one million inhabitants, value that places Italy among the first Countries in the world. According to the data of WHO Centre in Uppsala, evaluating the period between March 2009 and March 2014, Italy ranks at the thirteenth place for reporting rate.
More than half of the reports come from hospital doctors, but reports from all other health professionals are also increasing. Overall, almost 11,000 health professionals sent a report in 2013. Among these, an increase has been registered also for general practitioners. Their reports represent 7% of the total, but increased by 25% in respect to 2012, with an increment of 35% in the number of reporters. Citizens’ direct reporting accounts for about 8% of the total. Many of these forms are linked to the project that involved territorial pharmacy, which we already discussed last year in the article about spontaneous reporting. Table 2 shows the 20 most reported drugs in the last 3 years (excluding vaccines). The list includes essentially anticoagulants, antiaggregants, antibiotics, NSAIDs and anticancer drugs. In 2013 there has been a decrease in the number of reports for lenalidomide and docetaxel, while ibuprofen, ketoprofen, levofloxacin and paclitaxel registered an increase.
Table 2 – The 20 most reported drugs in the last three years (excluding vaccines)
|Drug||2011||2011 Rank||2012||2012 Rank||2013||2013 Rank||Total|
The situation of spontaneous reporting in Italy is, therefore, very positive. The high number of reports allow an effective analysis of the signals, which is periodically carried out by AIFA together with the Regional Centres for Pharmacovigilance both on national data and Eudravigilance data (in regard to drugs for which Italy is Reference Member State at European level). The most interesting signals are published on the AIFA website. Rhabdomyolysis caused by allopurinol, off label use of ketorolac and transplant rejection due to interaction between macrogol and cyclosporine have been commented during the first semester 2013. For the last few years, we have been wondering how long this rapid growth might continue. In the first 4 months of 2014, the number of forms results in further increment by 9% in respect to the same period in 2013, despite the fund decrease for pharmacovigilance already mentioned. The real problem now is the sustainability of the system for managing such an elevate number of reports. In Italy, all reports – even if sent by email – are manually entered in the National Network for Pharmacovigilance for coding the information about drugs, reactions and diseases.
The work-load for pharmacovigilance representatives within the Local Health Services (ASL) - that, besides entering the reports, are required to deal with drug industries’ requests and to organize educational/informative activities for the reporters (i.e. other health professionals) - has reached unsustainable levels, especially if we consider that pharmacovigilance is often just one task for these professionals.
Also the Regional Centres for Pharmacovigilance, directly involved in many activities described by the Guidelines and by AIFA standard operative procedures, are struggling, mostly because of lack of structured personnel. Reports digitalization, already present in many Countries but not yet active in Italy, is now a necessity and AIFA is working on this front.
It would be also important to better organize tasks and roles for local and regional centre supervisors, optimizing the work and avoiding useless redundancy.