Abstract P376: The Monitoring by a Pharmacist Facilitator, of Side Effect, is Useful to Report Adverse Reactions Associated With Antihypertensive Agents in Practical Clinic in South Italy

Abstract

Adverse Drug Reactions (ADRs) are a serious health related problem, which can limit the treatment options, compliance and even leads to discontinuation of therapy. Unfortunately not in all countries, the reporting reaches standard levels set by the WHO. As well, in our region (Calabria), located in south of Italy, only few reports are usually reported. For these reasons, the Italian Agency of the Drugs (AIFA) has been promoting and financing regional projects with multidisciplinary groups to increase spontaneous reporting. From first January 2018, we started a survey program finalized to report all adverse events from antihypertensive drugs observed in our Cardiovascular Prevention Clinic. We evaluated all of the 250 outpatients (≥18 years), consecutively visited in our clinic, from 1 January 2018 to 30 April 2018. All of these were in antihypertensive treatment (monotherapy or multiple drugs therapy). A total of 20 ADRs were observed. Of the 20 ADRs, 19 were non-serious events; a serious event required hospitalization (atrial-ventricular complete block). Causality assessment has been estimated with the Naranjo algorithm; the results indicated n=19 possible ADRs and n=1 probable. Incidence of ADRs was found to be higher in the age group between 45 and 54 years old (6 of 20) and males experienced more ADRs than females (35%, 7 of 20). ADRs were more frequently associated with combination therapy (65%, 13 of 20) versus monotherapy. Calcium channel-blockers were found to be the most frequently associated drugs with ADRs (n=8), followed by angiotensin receptor blockers (n=4). We compared our reports with the reports, of the same period, available for our region obtained from National Pharmacovigilance Network. During this period were reported 27 side effect reactions in all our region (5 reports in the 2017). In conclusion, in the last 4 months, regional projects, with the creation of a multidisciplinary group composed of Medical and Pharmacists Facilitator, was useful in improving and increase quality and quantity of spontaneous reports in Calabria.