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Objective: During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014.Research design and methods: For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions).Results: A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions.Conclusions: During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

Adverse drug reaction (ADR) reporting by patients has a fundamental role in pharmacovigilance. The main objectives of the present study were to assess the impact of a pharmacist-based intervention in promoting direct patient reporting, to evaluate patient ability to identify and report ADRs and to determine their pattern.The study involved 96 pharmacists in the Campania region of Italy, who interviewed their customers and asked them whether they had experienced an ADR. Patients who had experienced an ADR were invited to complete an ADR reporting form. The quality of completed ADR reporting forms was evaluated before their entry into the Italian Spontaneous Reporting System (Rete Nazionale di Farmacovigilanza [RNF]) and, once entered, their pattern was determined.A total of 18,677 patients were interviewed, and 10.88% had experienced an ADR. After quality control, 54.32% of all reporting forms were entered into the RNF so that patient contribution to spontaneous reporting, null over the years, reached ∼7%. Patients reported mainly non-serious (91.28%) and expected (94.62%) ADRs, and NSAIDs or antibiotics were the most frequently reported drugs.The study shows that pharmacists can have an important role in promoting patient reporting and adds new information on how a patient reporting form should be structured.