Adverse Drug Reaction Reporting in Ethiopia: Systematic Review

Hailu, Abel Demerew; Mohammed, Solomon Ahmed

doi:10.1155/2020/8569314

Cited by 16 publications

(8 citation statements)

References 29 publications

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“…5 However, these secondline drugs tend to be toxic and their longer duration of use predisposes patients to adverse drug reactions (ADRs). 6 Until 2015, treatment of MDR-TB involved the use of more toxic and longer duration (20)(21)(22) regimens in Uganda. 7,8 However, the introduction of shorter duration (9-12 months) and more tolerable regimens has redefined clinical research and management of MDR-TB.…”

Section: Introductionmentioning

confidence: 99%

“…12,20 In addition to the disruption of therapy in terms of compliance, ADRs are also associated with other negative outcomes including increased length of hospital stay and severe illness. 5,21 Given the scantiness of data about ADRs among patients receiving MDR-TB treatment and changes in local patterns of TB and MDR-TB prevalence in Uganda, this study aimed to assess the prevalence, types, and factors associated with ADRs among patients receiving MDR-TB treatment at Mbarara Regional Referral Hospital (MRRH), in southwestern Uganda.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse drug reactions and associated factors in multidrug-resistant tuberculosis: A retrospective review of patient medical records at Mbarara Regional Referral Hospital, Uganda

et al. 2023

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Objectives: The World Health Organization pragmatic guidelines recommend shorter duration drug regimens with newer, more efficacious agents for treatment of multidrug-resistant tuberculosis. However, adverse drug reactions associated with the use of newer, second-line agents may pose a major barrier to adequate management of multidrug-resistant tuberculosis. We therefore sought to investigate the prevalence and factors associated with adverse drug reactions among patients with multidrug-resistant tuberculosis. Methods: We retrospectively reviewed patient medical records at the tuberculosis treatment unit of Mbarara Regional Referral Hospital, between January 2013 and December 2020. Medical records were included in the study, if the patients were aged ⩾18 years, tested sputum positive for multidrug-resistant tuberculosis, with adequate pharmacovigilance data documented. We assessed all documented health-related patient complaints, deranged laboratory values, and clinician suspected adverse drug reactions for scientific/clinical plausibility. Adverse drug reactions were confirmed using published and manufacturer drug references materials. A multidisciplinary clinician team was involved to decide whether to exclude or include a suspected adverse drug reaction. Results: About 6 in 10 (67.4%; 120/178) patients experienced at least one adverse drug reactions during treatment, of which 18.3%, 14.6%, and 11.4% of adverse drug reactions affected the endocrine/metabolic, otic, and musculoskeletal body systems, respectively. Majority of the adverse drug reactions were probable and had a moderate severity. There was an upward trend in adverse drug reaction incidence between 2015 and 2019. Adverse drug reaction occurrence was associated with previous adverse drug reaction history (adjusted odds ratio = 2.85 (1.08, 7.53 at 95% confidence interval)); however, patients who were underweight (adjusted odds ratio = 0.34 (0.16, 0.69 at 95% confidence interval)) and those treated with bedaquiline-based drug regimens (adjusted odds ratio = 0.2 (0.07, 0.59 at 95% confidence interval)) were less likely to experience an adverse drug reaction. Conclusion: Majority of patients with multidrug-resistant tuberculosis experience at least adverse drug reaction during the course of treatment. The newer standard shorter duration drug regimens (9–12 months) may be associated with intolerable adverse drug reactions that hamper effective management of multidrug-resistant tuberculosis. There is need for more studies to assess the clinical adverse drug reaction burden associated with the implementation of shorter duration regimens.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse drug reactions and associated factors in multidrug-resistant tuberculosis: A retrospective review of patient medical records at Mbarara Regional Referral Hospital, Uganda

et al. 2023

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“…Reporting ADR is a breach of patient confidentiality, Reporting creates an additional workload and a lacks of motivation for reporting was also believed to be reasons for not reporting by 12.6%,47%), and 36.3% of the respondents, respectively. These reasons are found to be in common in the findings of the study conducted at public hospitals of Ethiopia (19). Assessment of ADR reporting practice determinants indicated that only being a druggist and pharmacy technician was a significant determinant of ADR reporting practice.…”

Section: Discussionmentioning

confidence: 59%

Assessment of Knowledge, Attitude, and Practice of Adverse Drug Reaction Reporting Among Community Pharmacy in Gondar Town, Ethiopia, 2021

Zimamu¹,

Agimas²,

Wubet

2021

Preprint

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Background: Drugs can treat diseases, reduce symptoms, and enhance patients’ health and quality of life. However, taking a drug is not always as easy as just swallowing a pill. This is because drugs have some unwanted effects. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Objectives: To assess knowledge, attitude, and practice of health care providers on adverse drug reporting among community pharmacists, Gondar, Ethiopia Methods: Community-based cross-sectional study designs were used from July - August 2021. The sampling method was a survey from community pharmacists. Self-administered questioner was used, and the collected data was entered into Epi-info Version 7.0 and exported to SPSS version 20 software for analysis. Result: The study included 215 community pharmacy professionals to assess the knowledge, attitudes, and practices of adverse drug reaction reporting. From a total of 215 community pharmacy professionals, 34 (15.8%) of the respondents were able to differentiate ADR from side effects and only 56(26%) respondents felt that they are adequately trained in ADR reporting. Out of 215 respondents, 78(36.3%) and 146(67.9%) knew the availability of the national reporting system and ADR reporting form in Ethiopia respectively. The study revealed that 21.4% [95% CI: 18.6-35.9] and 42.3% [95% CI: 38.2-65.9] of community pharmacists have poor knowledge and negative attitude towards ADR reporting respectively. Conclusion: Underreporting of ADR by community pharmacists was identified in this study. Training sessions to clarify the role of various community pharmacists in ADR reporting will hopefully fill the observed gap in knowledge and practices. The community pharmacy should formulate strategies to enhance the detection and reporting of ADRs.

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“…Similarly, a systematic review in India reported that 55.6% of the health professionals were not aware of the national pharmacovigilance program [ 53 ]. In another systematic review in Ethiopia, 45.9% of health professionals were aware of the national ADR reporting system and their knowledge of ADR was determined (41.5%) [ 54 ]. Therefore, it seems that healthcare authorities should increase nurses' knowledge about the PV system and also facilitate nurses' awareness of ADR reporting form by adopting appropriate strategies.…”

Section: Discussionmentioning

confidence: 99%

Nurses’ Knowledge, Attitudes, and Practice in Relation to Pharmacovigilance and Adverse Drug Reaction Reporting: A Systematic Review

Salehi

Seyedfatemi

Mirzaee

et al. 2021

BioMed Research International

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Aim. To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective. Methods. A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses’ knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included. Results. Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint. Conclusion. Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses’ knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.

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Adverse Drug Reaction Reporting in Ethiopia: Systematic Review

Cited by 16 publications

References 29 publications

Adverse drug reactions and associated factors in multidrug-resistant tuberculosis: A retrospective review of patient medical records at Mbarara Regional Referral Hospital, Uganda

Adverse drug reactions and associated factors in multidrug-resistant tuberculosis: A retrospective review of patient medical records at Mbarara Regional Referral Hospital, Uganda

Assessment of Knowledge, Attitude, and Practice of Adverse Drug Reaction Reporting Among Community Pharmacy in Gondar Town, Ethiopia, 2021

Nurses’ Knowledge, Attitudes, and Practice in Relation to Pharmacovigilance and Adverse Drug Reaction Reporting: A Systematic Review

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