Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy.

TY - JOUR

T1 - Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy.

AU - Parretta, Elisabetta

AU - Rafaniello, Concetta

AU - Magro, Lara

AU - Coggiola Pittoni, Anna

AU - Sportiello, Liberata

AU - Ferrajolo, Carmen

AU - Mascolo, Annamaria

AU - Sessa, Maurizio

AU - Rossi, Francesco

AU - Capuano, Annalisa

PY - 2014/9

Y1 - 2014/9

N2 - OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

AB - OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

KW - Adolescent

KW - Adult

KW - Adverse Drug Reaction Reporting Systems

KW - Adverse Drug Reaction Reporting Systems: statistic

KW - Aged

KW - Community Pharmacy Services

KW - Community Pharmacy Services: organization & admini

KW - Drug-Related Side Effects and Adverse Reactions

KW - Drug-Related Side Effects and Adverse Reactions: e

KW - Female

KW - Humans

KW - Italy

KW - Italy: epidemiology

KW - Male

KW - Middle Aged

KW - Pharmacists

KW - Pharmacists: organization & administration

KW - Pharmacovigilance

KW - Professional Role

KW - Self Report

KW - Young Adult

U2 - 10.1517/14740338.2014.939582

DO - 10.1517/14740338.2014.939582

M3 - Journal article

SN - 1474-0338

VL - 13 Suppl 1

SP - S21-9

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

ER -