Joanne Barnes1, Rachael Butler2. 1. School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. j.barnes@auckland.ac.nz. 2. , Auckland, New Zealand.
Abstract
INTRODUCTION: Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacists submit few CMs ADR reports. OBJECTIVES: The aim of this study was to explore New Zealand community pharmacists' views and experiences with ADR reporting for CMs. METHODS: Qualitative, in-depth, semi-structured interviews were undertaken with 27 practising community pharmacists identified through purposive and convenience sampling. Data were analysed using a general inductive approach. RESULTS: Participants were familiar with systems for reporting ADRs, believed ADR reporting for CMs important, and that pharmacists should contribute. However, few submitted reports of CMs ADRs and none encouraged patients/consumers to do so. Participants explained this was because they had never been informed by patients about ADRs associated with CMs. Participants said they would report serious ADRs; time pressures, lack of certainty around causality, lack of awareness of mechanisms for reporting CMs ADRs, and lack of remuneration were deterrents to reporting. Participants were aware of intensive-monitoring studies for prescription medicines, understood the rationale for considering this approach for CMs and recognised there would be potential practical difficulties. CONCLUSIONS: Participants used their knowledge of CMs safety concerns to minimise risk of harms to consumers from CMs use, but most had a passive approach to identifying and reporting ADRs for CMs. There is substantial potential for pharmacists to adopt proactive strategies in pharmacovigilance for CMs, particularly in recognising and reporting ADRs, and empowering CMs users to do the same.
INTRODUCTION: Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacists submit few CMs ADR reports. OBJECTIVES: The aim of this study was to explore New Zealand community pharmacists' views and experiences with ADR reporting for CMs. METHODS: Qualitative, in-depth, semi-structured interviews were undertaken with 27 practising community pharmacists identified through purposive and convenience sampling. Data were analysed using a general inductive approach. RESULTS:Participants were familiar with systems for reporting ADRs, believed ADR reporting for CMs important, and that pharmacists should contribute. However, few submitted reports of CMs ADRs and none encouraged patients/consumers to do so. Participants explained this was because they had never been informed by patients about ADRs associated with CMs. Participants said they would report serious ADRs; time pressures, lack of certainty around causality, lack of awareness of mechanisms for reporting CMs ADRs, and lack of remuneration were deterrents to reporting. Participants were aware of intensive-monitoring studies for prescription medicines, understood the rationale for considering this approach for CMs and recognised there would be potential practical difficulties. CONCLUSIONS:Participants used their knowledge of CMs safety concerns to minimise risk of harms to consumers from CMs use, but most had a passive approach to identifying and reporting ADRs for CMs. There is substantial potential for pharmacists to adopt proactive strategies in pharmacovigilance for CMs, particularly in recognising and reporting ADRs, and empowering CMs users to do the same.
Authors: Kees van Grootheest; Sten Olsson; Mary Couper; Lolkje de Jong-van den Berg Journal: Pharmacoepidemiol Drug Saf Date: 2004-07 Impact factor: 2.890
Authors: Tessa K Morgan; Margaret Williamson; Marie Pirotta; Kay Stewart; Stephen P Myers; Joanne Barnes Journal: Med J Aust Date: 2012-01-16 Impact factor: 7.738