Background and importance The main objectives of active pharmacovigilance (FA) projects are to identify potential warning signs regarding the use of drugs, prevent adverse reactions (ADRs) and promote the safe and effective use of medicines.
Aim and objectives The aim of this work was to assess the introduction of measures designed to tackle clinical appropriateness and safety, organisation of interdisciplinary work groups, awareness of health personnel and monitoring adherence to chronic therapies.
Material and methods Analysis of reports included in a national pharmacovigilance network (RNF) by our territorial healthcare hospital (ASST) was conducted, during two time periods of 230 days each, one preceding and one following the beginning of the FA project with a dedicated pharmacist.
Results In the first period, 66 reports were included, of which 15 were serious and 51 were not serious. The signallers were physicians (55) and pharmacists (11). The age group most involved were those aged >65 year (50%). Women were involved in 70% of ADRs. There were 76 suspected drugs, 50% represented by antineoplastics. The most reported ADRs, described for preferred term (PT), were erythema (8), pruritus (7), hypotension (6) and urticaria (5), for a total of 134 different PTs. In the second period there were 107 reports, of which 79 were not serious and 28 were serious (2 deaths). In addition to pharmacists (66) and physicians (36), 5 ADRs were added by other health professionals. The age group most involved was 18–65 years (56%). There were 134 suspected drugs, with a 106% increase in reports of suspected non-antineoplastic drugs (30–62). The most reported adverse reactions were pruritus, dyspnoea, erythema and neutropenia, for a total of 241 PTs (80% increase compared with the first period).
Conclusion and relevance In addition to a significant increase in the number of reports, there was an evident increase in the type of drugs and reactions reported, thanks to the collaboration and awareness of health personnel and patients. With the peculiar organisation of the ASST, divided into two sectors (namely territorial network and hospital centre), the pharmacist can carry out pharmacovigilance activity on various levels, such as hospital department, direct distribution of drugs, family counselling, vaccination centres and assistance continuity services. This promotes the increase in quantity and quality of reports, and contributes to improving and updating the safety profile of drugs, favouring the appropriateness of their use.
References and/or acknowledgements No conflict of interest.
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