George Tsey Sabblah1, Delese Mimi Darko2, Hudu Mogtari2, Linda Härmark3, Eugène van Puijenbroek3,4. 1. Food and Drugs Authority, P. O. Box CT2783, Accra, Ghana. georgesabblah@gmail.com. 2. Food and Drugs Authority, P. O. Box CT2783, Accra, Ghana. 3. Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, 's-Hertogenbosch, The Netherlands. 4. PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands.
Abstract
INTRODUCTION: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. OBJECTIVE: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. METHODS: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. RESULTS: Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting. CONCLUSION: Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.
INTRODUCTION: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. OBJECTIVE: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. METHODS: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. RESULTS: Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting. CONCLUSION:Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.
Authors: Paul Gavaza; Carolyn M Brown; Kenneth A Lawson; Karen L Rascati; James P Wilson; Mary Steinhardt Journal: Res Social Adm Pharm Date: 2010-11-05
Authors: Paul Gavaza; Carolyn M Brown; Kenneth A Lawson; Karen L Rascati; James P Wilson; Mary Steinhardt Journal: Br J Clin Pharmacol Date: 2011-07 Impact factor: 4.335
Authors: Florence van Hunsel; Attje Talsma; Eugène van Puijenbroek; Lolkje de Jong-van den Berg; Kees van Grootheest Journal: Pharmacoepidemiol Drug Saf Date: 2010-12-28 Impact factor: 2.890
Authors: Linda Härmark; June Raine; Hubert Leufkens; I Ralph Edwards; Ugo Moretti; Viola Macolic Sarinic; Agnes Kant Journal: Drug Saf Date: 2016-10 Impact factor: 5.606
Authors: Leàn Rolfes; Florence van Hunsel; Sarah Wilkes; Kees van Grootheest; Eugène van Puijenbroek Journal: Pharmacoepidemiol Drug Saf Date: 2014-07-31 Impact factor: 2.890
Authors: Haggar H Ampadu; Jarno Hoekman; Marieke L de Bruin; Shanthi N Pal; Sten Olsson; Daniele Sartori; Hubert G M Leufkens; Alexander N O Dodoo Journal: Drug Saf Date: 2016-04 Impact factor: 5.606
Authors: Cristiano Matos; Florence van Hunsel; Rogério Tavares Ribeiro; Dulce Nascimento do Ó; João Filipe Raposo Journal: Ther Adv Drug Saf Date: 2020-09-04
Authors: Bernard Appiah; Anubhuti Poudyal; James N Burdine; Lucy Asamoah-Akuoko; David Anidaso Anum; Irene Akwo Kretchy; George Sabblah; Alexander N O Dodoo; E Lisako J McKyer Journal: Ther Adv Drug Saf Date: 2019-09-14