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      Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria

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          Abstract

          Background

          Higher incidence of adverse drug reactions (ADRs) is a global health problem requiring attention of all stakeholders regardless of the practice settings. This study therefore aimed to evaluate awareness, knowledge, attitude and practice of ADR reporting among health workers and patients in 10 primary healthcare centres (PHCs) in Ibadan, southwestern Nigeria.

          Methods

          Questionnaire-guided cross-sectional survey among 80 health workers and 360 patients enrolled from the selected PHCs between October and December 2018. The semi-structured questionnaires generally comprised open-ended and closed-ended questions to explore general knowledge and awareness of ADRs and pharmacovigilance, while other question-items evaluated attitude towards ADR reporting and ADR reporting practice. Overall percent score in the knowledge and attitude domains for the health workers was developed into binary categories of > 80 versus ≤80% for “adequate” and “inadequate” knowledge, as well as “positive” and “negative” attitude, respectively. Data were summarised using descriptive statistics, while Chi-square test was used to evaluate categorical variables at p < 0.05.

          Results

          Overall, 58(72.5%) health workers had heard of pharmacovigilance , but only 3(5.2%) correctly understood the pharmacovigilance concept. Twelve (15.0%) showed adequate knowledge of ADRs, while 37(46.2%) demonstrated positive attitude towards ADR reporting. Thirty (37.5%) health workers had come across ADR reporting form, while 79(98.8%) expressed willingness to report all ADRs encountered. Of the patients, 31(8.6%) had heard of pharmacovigilance, 143(39.7%) correctly cited ADR definition, while 67(18.6%) reported the previously experienced ADRs. Informing healthcare professional (38; 38.8%) was the most common measure taken by patients when they experienced reaction(s). Nurses significantly had adequate knowledge of ADRs ( p < 0.001) compared to other cadres.

          Conclusions

          Health workers in the selected PHCs were largely aware of pharmacovigilance but show low level of knowledge about ADRs and pharmacovigilance concept, with moderately positive attitude towards ADR reporting. Patients on the other hand demonstrate low level of awareness of pharmacovigilance and ADR reporting, with less than one-fifth who reported the previously experienced ADRs. This perhaps underscores a need for regular mandatory education and training on ADRs/pharmacovigilance concept among the PHC health workers, while continuous public enlightenment and awareness campaign on spontaneous reporting of ADRs is advocated in order to enhance reporting rate.

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          Most cited references32

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          Under-reporting of adverse drug reactions : a systematic review.

          The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%. This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals.
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            WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems

            Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed.
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              Self-reported medication adherence and cardiovascular events in patients with stable coronary heart disease: the heart and soul study.

              Nonadherence to physician treatment recommendations is an increasingly recognized cause of adverse outcomes and increased health care costs, particularly among patients with cardiovascular disease. Whether patient self-report can provide an accurate assessment of medication adherence in outpatients with stable coronary heart disease is unknown. We prospectively evaluated the risk of cardiovascular events associated with self-reported medication nonadherence in 1015 outpatients with established coronary heart disease from the Heart and Soul Study. We asked participants a single question: "In the past month, how often did you take your medications as the doctor prescribed?" Nonadherence was defined as taking medications as prescribed 75% of the time or less. Cardiovascular events (coronary heart disease death, myocardial infarction, or stroke) were identified by review of medical records during 3.9 years of follow-up. We used Cox proportional hazards analysis to determine the risk of adverse cardiovascular events associated with self-reported medication nonadherence. Of the 1015 participants, 83 (8.2%) reported nonadherence to their medications, and 146 (14.4%) developed cardiovascular events. Nonadherent participants were more likely than adherent participants to develop cardiovascular events during 3.9 years of follow-up (22.9% vs 13.8%, P = .03). Self-reported nonadherence remained independently predictive of adverse cardiovascular events after adjusting for baseline cardiac disease severity, traditional risk factors, and depressive symptoms (hazards ratio, 2.3; 95% confidence interval, 1.3-4.3; P = .006). In outpatients with stable coronary heart disease, self-reported medication nonadherence is associated with a greater than 2-fold increased rate of subsequent cardiovascular events. A single question about medication adherence may be a simple and effective method to identify patients at higher risk for adverse cardiovascular events.
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                Author and article information

                Contributors
                +2348034226199 , adisaras73@yahoo.co.uk , rasaq.adisa@mail.ui.edu.ng
                otomi2541@gmail.com
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                3 December 2019
                3 December 2019
                2019
                : 19
                : 926
                Affiliations
                ISNI 0000 0004 1794 5983, GRID grid.9582.6, Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, , University of Ibadan, ; Ibadan, Nigeria
                Article
                4775
                10.1186/s12913-019-4775-9
                6889459
                31796034
                40dd9769-5a3a-4857-a2e0-0bac0d7301cd
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 July 2019
                : 22 November 2019
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Health & Social care
                adverse drug reaction reporting,awareness, knowledge, attitude, and practice,primary healthcare worker,patients

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