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A Retrospective Review of Serious Adverse Drug Reaction Reports in the Nigerian VigiFlow Database from September 2004 to December 2016

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Abstract

Background

Adverse drug reactions (ADRs) are a source of concern in healthcare as they negatively affect patients. Serious adverse drug reactions (SADRs) have an even greater impact on patients and the system in terms of morbidity and financial burden. The establishment of National Pharmacovigilance Centers (NPCs) has enhanced ADR reporting in Africa. The Nigerian Pharmacovigilance Centre has been collecting ADR reports using VigiFlow since 2004.

Objective

The aim of this study was to identify and analyze SADR reports in the Nigerian VigiFlow database in order to profile the patients with SADRs, the medicines most implicated, system organ classes (SOCs) affected, outcome of such reactions, including fatalities, and ADR reporting trends over the years. We also looked at the data elements provided in the reports as a proxy measure of report quality.

Method

We retrospectively assessed all individual case safety reports (ICSRs) received by the NPC in Nigeria and entered into VigiFlow as SADR reports between September 2004 and December 2016. We defined SADR as any untoward reaction to any medicine dose that resulted in death, required in-patient hospitalization or prolongation of existing hospitalization, resulted in congenital anomaly, persistent or significant disability/incapacity or was life-threatening. The suspected SADRs were analyzed at the Medical Dictionary for Regulatory Activities SOC and Preferred Term levels.

Results

A total of 11,222 ICSRs were entered into VigiFlow during the study period, of which 298 (3%) were classified as SADR reports. Adults were the most affected (244/282; 87%). The median number of medicines per report was 3 (interquartile range = 2–4.75). Nevirapine (36/336; 11%), as a single entity, was the most reported medicine. Human immunodeficiency virus (HIV) infection affected 128/232 (55%) of those with SADRs. There was no statistically significant association between the number of reactions per report and sex of the patients (p = 0.280), their age groups (p = 0.670), or the number of medicines per report (p = 0.640). Hospitalization was the most frequently cited reason for classifying a report as serious (151/276; 53%) and death was reported in 48 cases (48/283; 17%). Based on the SOC, skin and subcutaneous tissue disorders (139/550; 25%) was the most affected, while anemia (55/550; 10%) was the most reported specific reaction. A substantial number of patients (107/256; 42%) either recovered fully or were recovering from the SADRs. The number of SADR reports received varied by year with no consistent trend.

Conclusion

There is under-reporting of ADRs in the Nigerian VigiFlow® database, particularly SADRs and those involving pediatric and geriatric age groups. Given that over half of the SADR reports involved antiretroviral drugs, it is imperative to increase the surveillance of ADRs related to this class of drugs through regular clinical assessment of reports and provision of feedback on the findings to healthcare providers. Direct consumer reporting should also be encouraged as a means of increasing ADR reporting.

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Authors and Affiliations

  1. National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria

    Comfort Kunak Ogar, Abiodun Abiola, Daniel Yuah, Ali Ibrahim, Emmanuel C. Amadi & Mojisola Christianah Adeyeye

  2. University of Lagos, Lagos, Nigeria

    Ibrahim Adekunle Oreagba

  3. Pharmacology, Therapeutic and Toxicology Department, Lagos State University College of Medicine, Lagos, Nigeria

    Kazeem Adeola Oshikoya

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  1. Comfort Kunak Ogar
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  2. Abiodun Abiola
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  8. Kazeem Adeola Oshikoya
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Contributions

CKO conceived the study. CKO and AA developed the proposal for the study. KAO and IO reviewed the proposal. ECA extracted data from VigiFlow for analysis. CKO and DY analyzed the extracted data. CKO drafted the manuscript. AI, IO, KAO, AA, ECA, DY reviewed and approved the manuscript.

Corresponding author

Correspondence to Comfort Kunak Ogar.

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Funding

The authors received no funding for this study.

Conflict of interest

C.K. Ogar declares no conflict of interest relating to this article. A. Abiola declares no conflict of interest relating to this article. D. Yuah declares no conflict of interest relating to this article. A. Ibrahim declares no conflict of interest relating to this article. I.A. Oreagba declares no conflict of interest relating to this article. E.C. Amadi declares no conflict of interest relating to this article. M.C. Adeyeye declares no conflict of interest relating to this article. K.A. Oshikoya declares no conflict of interest relating to this article.

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Ethics approval was not required for this study.

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Ogar, C.K., Abiola, A., Yuah, D. et al. A Retrospective Review of Serious Adverse Drug Reaction Reports in the Nigerian VigiFlow Database from September 2004 to December 2016. Pharm Med 33, 145–157 (2019). https://doi.org/10.1007/s40290-019-00267-2

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