The Italian regulatory body AIFA has announced a new system allowing the public and health professionals access to information held on the national database of adverse drug reactions. The database can be searched by brand name or active ingredient.
Pharmaceutical companies will be interested to learn that patients and health professionals in Italy can now search for data on the side-effects of all marketed drugs via a new system set up by the drug regulatory agency, AIFA, that gives them access to information on the National Pharmacovigilance Network database.
The Medicines Adverse Reactions system, which can be accessed via the AIFA website, allows health professionals and the public to search the database for adverse drug reaction (ADR) signals recorded for any medicine since 2002. The information is organized by year of entry and is updated every three months.
Searches can be conducted by the trade name of the drug involved or by the name of the active ingredient(s). In the latter case, the system will show all ADR signals relating to drugs containing the active ingredient(s) concerned, AIFA says.
Results of searches can be viewed in five different formats. The first shows the total number of signals recorded each year since the product was registered on the database. The second provides the number and percentage of signals depending on the seriousness of the ADR, while the third shows the number and percentage by the patient’s gender and age bracket.
The fourth format shows the number and percentage of signals classified by body system or organ affected (e.g., cardiac, respiratory), while the fifth uses the more detailed “preferred term” (a specific effect such as anxiety or tachycardia).
AIFA points out that the data in the database relate to suspected ADRs that may not necessarily be attributable to the medicine concerned – for example, there may be only a temporal connection – and that the information should not be taken to mean that the drug actually caused the reaction or that taking it is unsafe.
The data may come from spontaneous reporting or from active pharmacovigilance projects or post-marketing observational studies – in the latter case, the number of ADRs associated with targeted medicines may be higher than would be the case in normal conditions of use, the agency notes.
It also reminds health professionals and patients of the need to report suspected adverse reactions to medicines as they represent “an important source of information for pharmacovigilance activities,” and encourages them to report any such reactions using the AIFA website.
The Italian pharmacovigilance network receives data from AIFA, 20 regions and two provinces, more than 200 local health units, 112 hospitals, 38 scientific research institutes, and 561 pharmaceutical companies, AIFA notes. It is also connected to the EU EudraVigilance network, an enhanced version of which is due to go live on Nov. 22 this year following the launch of a testing environment in June. (Also see "EMA To Clarify Member State-Specific Requirements For New EudraVigilance System" - Pink Sheet, 7 Aug, 2017.)