The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study

Ndagije, Helen Byomire; Nambasa, Victoria; Manirakiza, Leonard; Kusemererwa, Donna; Kajungu, Dan; Olsson, Sten; Speybroeck, Niko

doi:10.1007/s40264-018-0659-x

Cited by 20 publications

(22 citation statements)

References 33 publications

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“…Finally, with only 10 days for data orientation, quality assurance, formal analyses and discussion of recommendations, the analyses presented are illustrative rather than comprehensive. In particular, we performed no dose-related analyses [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

“…This review focused on ADR onsets with known start dates in 2012–2015. For simplicity and to minimize loss of generality, we analysed only ADR onsets whose VigiBase ® serial number began UG-NDA, and we did not analyse dosages [ 13 ]. See the Electronic Supplementary Material (ESM) for details of how pharmacovigilance reports are processed in Uganda’s VigiBase ® .…”

Section: Methodsmentioning

confidence: 99%

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Adverse Drug Reaction Onsets in Uganda’s VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses

Kiguba

Ndagije²,

Nambasa³

et al. 2018

Pharm Med

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IntroductionDeveloping countries can improve their pharmacovigilance systems by analysing their own medication safety data.ObjectiveThe aims of this study were to characterize Uganda’s reported adverse drug reaction (ADR) onsets in 2012–2015 that were registered on VigiBase® by 31 December 2017, to document delays in international visibility and the influence of covariates on this delay from ADR onsets in 2013 + 2014, to examine data quality, and to illustrate analytical approaches for safety data, particularly for patients receiving antiretroviral therapy (ART).MethodsInternational delay was defined as elapsed time from complete ADR onset date to entry date on VigiBase®, with covariates examined using Cox proportional hazards regression. Simple random sampling was used to locate the paper-based ADR forms for data quality assurance. Disproportionality for signal detection focused on serious singleton ADR onsets in patients receiving ART.ResultsUganda’s VigiBase® had 1018 patient entries with complete ADR onset dates: 260 in 2012, 293 in 2013, 305 in 2014 and 160 in 2015. Only 16% (154/953) of ADR onsets in 2012–2015 were in patients aged < 20 years for whom randomly sampled ADR forms were less fully completed; 87% (889/1018) comprised a singleton sign/symptom; half were serious. Median delay from ADR onset to international visibility was 11 months for ADR onsets in 2013 + 2014, and longest for healthcare professionals other than pharmacists and physicians. Disproportionality for serious ADR onsets in patients receiving ART included anaemia with zidovudine, renal impairment with tenofovir, Stevens–Johnson syndrome with nevirapine and skin rash with efavirenz.ConclusionsBarely one ADR onset per day was registered on VigiBase® from those submitted to Uganda’s National Pharmacovigilance Centre during 2012–2014; only one in six was from patients aged < 20 years. Paediatric pharmacovigilance requires more emphasis in Uganda. Delays from reported ADR onset to international visibility on VigiBase® need to reduce dramatically. Quality assurance revealed rectifiable data entry deficits. Signal detection performed well for patients receiving ART.Electronic supplementary materialThe online version of this article (10.1007/s40290-018-0253-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Adverse Drug Reaction Onsets in Uganda’s VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses

Kiguba

Ndagije²,

Nambasa³

et al. 2018

Pharm Med

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“…In Uganda, patients and consumers report adverse drug events either indirectly through their healthcare provider or directly through the newly established online reporting system 24 . In the rural setting, the capacity of patients to report was assessed by a proxy variable seeking to find out if the respondents had ever experienced or reported an ADE both before and after the CDS intervention.…”

Section: Discussionmentioning

confidence: 99%

The effect of community dialogues and sensitization on patient reporting of adverse events in rural Uganda: uncontrolled before-after study

Ndagije¹,

Manirakiza²,

Kajungu

et al. 2018

Preprint

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19 Background: The patients that experience adverse events are in the best position to report 20 them, only if they were empowered to do so. Systematic community engagement and support 21 to patients in a rural setting to monitor any potential harm from medicines should provide 22 evidence for patient safety. 23 24 Methods: This paper describes an uncontrolled before and after study aimed at assessing the 25 effect of a community engagement strategy, the Community Dialogues and Sensitization 26 (CDS) intervention between January and April 2017, on the knowledge, attitude and practice 27 of reporting adverse drug events by community members in the two eastern Ugandan districts.2 28 A representative cross-sectional baseline household survey was done prior to the intervention 29 in September 2016 (n=1034) and the end-line survey (n=827) in July 2017.30 Results: After implementation of the CDS intervention, there was an overall 20% (95% CI=16-31 25) increase in awareness about adverse drug events in the community. The young people (15-32 24 years) demonstrated a 41% (95% CI =31-52) increase and the un-educated showed a 50% 33 (95% CI=37-63) increase in awareness about adverse drug events. The attitudes towards 34 reporting increased overall by 5% in response to whether there was a need to report ADEs 35 (95% CI =3-7). An overall 115% (95% CI =137-217) increase in the population that had ever 36 experienced ADEs was also reported.37 Conclusion: Our evaluation shows that the CDS intervention increases knowledge, improves 38 attitudes by catalyzing discussions among community members and health workers on health 39 issues and monitoring safety of medicines. 40 Key words: 41 Patient adverse drug event reporting, community dialogue and sensitization, rural health 42 setting 3 44 Background 45 46 Globally, adverse drug reactions account for up to 18% of hospital deaths 1-5. An adverse 47 event is defined as any untoward medical occurrence in a patient administered a medicinal 48 product and which does not necessarily have to have a causal relationship with the treatment, 49 including worsening of the clinical condition6. Like many resource-limited countries, Uganda 50 uses spontaneous reporting of suspected adverse drug events (ADE) predominantly by health 51 workers to monitor the safety of medicines7. However, one of the biggest inherent limitations 52 of this method is under-reporting. In as much as the Ugandan pharmacovigilance regulations 53 of 2014 require healthcare professionals to report adverse drug events, the grossly under-54 resourced health sector makes it hard for health workers to report them8. A recent study 55 reported an incidence of 25% of hospital-acquired suspected ADEs among Uganda inpatients9. 56 Antibiotics and anti-malarials have been the most commonly implicated drugs in community-57 acquired ADEs in surveys of healthcare professionals10. With increased access and use of 58 medicines in the community, it is becoming increasingly important to collect more safety 59 information by involving the pat...

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“…10,[13][14][15][16] Over the past decade, Burkina Faso has experienced a large-scale deployment of new essential drugs, especially artemisinin-based combination therapies (ACTs) for the treatment of uncomplicated malaria. 17 Although ACTs have been used successfully in Southeast Asia 18 and other SSA countries, [19][20][21][22][23] where they appear to be safe and well-tolerated, there is relatively limited experience with these medicines in Burkina Faso, where malaria transmission intensity is substantially higher. In addition, the pattern of antimalarial medicine use in real-life is quite different.…”

Section: Introductionmentioning

confidence: 99%

<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

Rouamba¹,

Sondo²,

Derra³

et al. 2020

DDDT

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Background and purpose: Resource-limited countries face challenges in setting up effective pharmacovigilance systems. This study aimed to monitor the occurrence of adverse events (AEs) after the use of artemisinin-based combination therapies (ACTs), identify potential drivers of reporting suspected adverse drug reactions (ADRs) and monitor AEs among women who were inadvertently exposed to ACTs in the first trimester of pregnancy. Patients and methods: We conducted a prospective observational study from May 2010 to July 2012 in Nanoro Health and Demographic Surveillance System (HDSS), Burkina Faso. The HDSS area was divided into active and passive surveillance areas to monitor AEs among patients (regardless of age or sex) who received a first-line ACT (artemetherlumefantrine or artesunate-amodiaquine). In the active surveillance area, patients were followed up for 28 days, while in the passive surveillance area, patients were encouraged to return voluntarily to the health facility to report any occurrence of AEs until day 28 after drug intake. We assessed the crude incidence rates of AEs in both cohorts and performed Cox regression with mixed random effects to identify potential drivers of ADR occurrence. Results: In total, 3170 participants were included in the study. Of these, 40.3% had reported at least one AE, with 39.6% and 44.4% from active and passive surveillance groups, respectively. The types of ADRs were similar in both groups. The most frequent reported ADRs were anorexia, weakness, cough, dizziness and pruritus. One case of abortion and eight cases of death were reported, but none of them was related to the ACT. The variance in random factors showed a high variability of ADR occurrence between patients in both groups, whereas variability between health facilities was low in the active surveillance group and high in passive surveillance group. Taking more than two concomitant medications was associated with high hazard in ADR occurrence, whereas the rainy season was associated with low hazard. Conclusion: This study showed that both passive and active surveillance approaches were useful tools. The HDSS allowed us to capture a few cases of exposure during the first trimester of pregnancy. The passive surveillance approach, which is more likely to be implemented by malaria control programs, seems to be more relevant in the Sub-Saharan African context.

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The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study

Cited by 20 publications

References 33 publications

Adverse Drug Reaction Onsets in Uganda’s VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses

Adverse Drug Reaction Onsets in Uganda’s VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses

The effect of community dialogues and sensitization on patient reporting of adverse events in rural Uganda: uncontrolled before-after study

<p>Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso</p>

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