Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Russom, Mulugeta; Tesfai, Dawit; Elias, Medhanie; Teklai, Merhawi; Bahta, Iyassu; Ahmed, Hagos; Tewolde, Melake; Usman, Abdulmumini; Gebregiorgis, Semere; Beyene, Eyob

doi:10.15226/2476-2431/2/1/00115

Cited by 8 publications

(44 citation statements)

References 24 publications

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“…Regarding associations with age, the association between ADR occurrence and prematurity which is attributable to reduced drug metabolism and clearance is also well established [26]. Previous hospital-based surveys in the United Kingdom [18,27], United States [17], and in sub-Saharan Africa [20] have also, similar to our finding, described an association between ADR occurrence and later childhood. This association has been explained by older children's ability to communicate their ADRs better than younger children [27].…”

Section: Discussionsupporting

confidence: 88%

“…High mortality and an association with medication error was also seen in the Ethiopian adverse drug event survey [22], where 9% of adverse drug events resulted in permanent harm or death, with three of the four events that resulted in permanent harm in that survey being due to medication error. Higher mortality rates than ours occurred in Eritrea, where 19/114 (17%) children admitted for ADRs died due to their ADRs [20], and in Nigeria, where 2/12 (17%) of children admitted for ADRs died due to their ADRs [21]. While our fatality rate may seem reassuringly low against these sub-Saharan African studies, it should be noted that an additional seven ADRs in our survey were considered nearfatal, meaning that 20% of serious ADRs may potentially have resulted in children's deaths.…”

Section: Discussioncontrasting

confidence: 58%

“…However, our survey excluded admissions to the oncology ward, whereas the 2012 systematic review's figure is significantly influenced by two large surveys which found ADR-related admissions to oncology wards to be common [17,18]. Published subsequent to the 2012 systematic review [4], surveys from paediatric settings in sub-Saharan Africa suggested the proportion of admissions due to ADRs to be 5.7% (16/282) in Cape Town, South Africa [19], 4.7% (114/2433) in Eritrea [20], and 0.60% (12/2004) in Lagos, Nigeria [21]. A study from Jimma, Ethiopia, with paediatric adverse drug events as outcome (i.e., a slightly different outcome than ADRs), determined the proportion of admissions to be adverse drug event-related as 0.63% (4/634) [22].…”

Section: Discussionmentioning

confidence: 99%

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Serious adverse drug reactions at two children’s hospitals in South Africa

et al. 2020

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Background: The high HIV prevalence in South Africa may potentially be shaping the local adverse drug reaction (ADR) burden. We aimed to describe the prevalence and characteristics of serious ADRs at admission, and during admission, to two South African children's hospitals. Methods: We reviewed the folders of children admitted over sequential 30-day periods in 2015 to the medical wards and intensive care units of each hospital. We identified potential ADRs using a trigger tool developed for this study. A multidisciplinary team assessed ADR causality, type, seriousness, and preventability through consensus discussion. We used multivariate logistic regression to explore associations with serious ADRs. Results: Among 1050 patients (median age 11 months, 56% male, 2.8% HIV-infected) with 1106 admissions we found 40 serious ADRs (3.8 per 100 drug-exposed admissions), including 9/40 (23%) preventable serious ADRs, and 8/40 (20%) fatal or near-fatal serious ADRs. Antibacterials, corticosteroids, psycholeptics, immunosuppressants, and antivirals were the most commonly implicated drug classes. Preterm neonates and children in middle childhood (6 to 11 years) were at increased risk of serious ADRs compared to infants (under 1 year) and term neonates: adjusted odds ratio (aOR) 5.97 (95% confidence interval 1.30 to 27.3) and aOR 3.63 (1.24 to 10.6) respectively. Other risk factors for serious ADRs were HIV infection (aOR 3.87 (1.14 to 13.2) versus HIV-negative) and increasing drug count (aOR 1.08 (1.04 to 1.12) per additional drug). Conclusions: Serious ADR prevalence in our survey was similar to the prevalence found elsewhere. In our setting, serious ADRs were associated with HIV-infection and the antiviral drug class was one of the most commonly implicated. Similar to other sub-Saharan African studies, a large proportion of serious ADRs were fatal or near-fatal. Many serious ADRs were preventable.

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Section: Discussionsupporting

confidence: 88%

Section: Discussioncontrasting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

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Serious adverse drug reactions at two children’s hospitals in South Africa

et al. 2020

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“…Anemia which was mostly associated with Zidovudine was the third most serious ADR, unlike previous studies that found anemia to be the most serious ADR [12, 16, 21]. This difference could be either due to the inappropriate laboratory monitoring of the patients on HAART in Halibet hospital which undermines the real frequency or due to the nature of this study.…”

Section: Discussionmentioning

confidence: 59%

“…Limited study has been conducted on the adverse effect of ART in Sub-Saharan countries, such as Eritrea, despite having high prevalence of HIV. A five-month prospective study conducted in Eritrea by Russom et al 2017 [12] aimed at measuring ADR related hospital admissions in all Eritrean hospitals showed first line ART drugs (Zidovudine/lamivudine and Tenofovir/lamivudine) to be among the top three drugs implicated in causing ADR related deaths. The study further added that ART associated anemia accounted for 20.8% of the ADR related deaths which could have easily been prevented by appropriate laboratory monitoring.…”

Section: Introductionmentioning

confidence: 99%

Nature and prevalence of adverse drug reaction of antiretroviral medications in Halibet National Referral Hospital: a retrospective study

Hagos

Anand

2019

BMC Pharmacol Toxicol

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Background Monitoring the safety of antiretroviral therapy (ART) remains a challenge in resource-constrained countries such as Eritrea due to their serious adverse drug reactions (ADRs). This study was aimed at assessing the prevalence, nature, seriousness and possible risk factors of ART associated ADRs in Halibet National Referral Hospital in Eritrea. Method A three month retrospective, longitudinal, descriptive study of patients treated with ART between September 2005 and December 2016 was conducted in Halibet National Referral Hospital. Demographic characteristics, treatment details, reaction and outcome details, laboratory investigations and other information was abstracted manually from patients’ clinical cards. Statistical analysis was conducted using both univariate and multivariate analysis and statistical significance was tested using 95% confidence intervals and/or p -value. A P -value < 0.05 was regarded as being statistically significant. Results Of the 309 patients screened, 62.8% encountered at least one ADR and 29.8% of the reactions were serious with similar male to female ratio. Gastrointestinal symptoms were the most common ADR and were associated mostly with Atripla followed by AZT + 3TC + NVP drug combinations, but lipodystrophy followed by peripheral neuropathy which were both commonly associated with Stavudine and anemia associated with Zidovudine were the most serious. Patients with CD4 count below 200 were more likely to develop ADRs ( p = 0.000). Conclusion ADRs associated with ART drugs in Halibet hospital were found to be highly prevalent. Furthermore, CD4 count below 200, was identified as a major risk factor that predisposes patients to ADRs. This is burdensome to resource constrained countries such as Eritrea who have limited drug options and high HIV prevalence, therefore these findings will help patients and healthcare professionals understand the nature as well as seriousness of these ADRs and identify the risks involved with ART medications which can help minimize ART associated ADRs early on.

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Serious adverse drug reactions in sub‐Saharan Africa in the era of antiretroviral treatment: A systematic review

Mouton

Jobanputra

Tatz

et al. 2021

Pharmacology Res & Perspec

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The burden of adverse drug reactions (ADRs) in low-and middle-income countries (LMICs) may differ from that in high-income settings for a variety of reasons, including differences in disease burden, differences in drug utilization patterns, a potential lack of effective drug quality control, and the high risk for prescribing and dispensing errors that occur in overburdened healthcare systems. Previous systematic reviews summarizing the global burden of ADRs 1-6 included only a few surveys from LMICs, which limits the generalizability of their results to LMIC settings.In sub-Saharan Africa (SSA), an epidemiological transition is taking place, with high prevalence of both non-communicable

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Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Cited by 8 publications

References 24 publications

Serious adverse drug reactions at two children’s hospitals in South Africa

Serious adverse drug reactions at two children’s hospitals in South Africa

Nature and prevalence of adverse drug reaction of antiretroviral medications in Halibet National Referral Hospital: a retrospective study

Serious adverse drug reactions in sub‐Saharan Africa in the era of antiretroviral treatment: A systematic review

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