The Italian post-marketing registries

The post-marketing registries, established by the Italian Medicines Agency in 2005, represent the example of a national application of an automated workflow handling the personalized drug distribution in hospital pharmacies and local public pharmaceutical services, with the intent of both improving the efficacy/efficiency of analysis and regulatory activities themselves, as well as closely monitoring the clinical activity. In fact, within the correct clinical practice the prescriber shall take into account the parameters, such as therapeutic drug indication, actual benefit the patient should gain in comparison to the trials, potential and actual risk of adverse reactions, drugs interactions, and cost of the therapy. On the track of the cancer registry’s experience, the Italian Medicines Agency has extended the scope to the following areas: ophthalmology, rheumatology, dermatology, orphan drugs, cardiology, diabetology, respiratory, and neurological diseases. It involves more than 60 drugs (most of them with risk sharing schemes on a population of over 400 000 patients) and is available from http://monitoraggio-farmaci.agenziafarmaco.it.