Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East

ABSTRACT

Background

Growing numbers of patients with diabetes mellitus in Africa and the Middle East on antidiabetic therapies necessitate understanding adverse event reporting in these regions. We assessed pharmaceutical industry insulin individual case safety report (ICSR) completeness and completeness-associated variables.

Research design and methods

The observational cross-sectional study, set in an insulin-manufacturing company’s safety database, assessed vigiGrade® completeness scores of African and Middle Eastern post-marketing ICSRs from January to December 2018, and case variables effects on completeness. Low vigiGrade® scores indicated poorly documented ICSRs.

Results

We analyzed 4854 ICSRs; 59.8% from the Middle East. The mean vigiGrade® score was 0.58. Middle Eastern ICSRs had higher mean scores than African ICSRs (0.65 vs. 0.46, p<0.001). Scores peaked at 0.32, 0.70, and 1.00 for Middle Eastern ICSRs compared to 0.35 and 0.50 for African ICSRs. Middle Eastern serious (0.77 vs. 0.47; p<0.001) and solicited (0.70 vs. 0.48; p<0.001) ICSRs had higher mean scores than African ICSRs. Mean scores were highest for Middle Eastern physicians (0.89) and other healthcare professionals (0.82), whereas, in Africa, scores were highest for consumer- (0.47) and pharmacist-reported ICSRs (0.47) (p<0.001).

Conclusions

Middle Eastern pharmaceutical industry insulin ICSRs were documented with greater detail than African ICSRs. Seriousness, report source, and reporter type significantly impacted ICSR completeness.

KEYWORDS:

• vigiGrade®
• completeness
• Africa
• Middle East
• insulin
• adverse event
• ICSR

Acknowledgments

We acknowledge Novo Nordisk® Global Safety who supplied the data for this research.

Declaration of interests

CRN Mlotshwa was employed by Novo Nordisk® at the time of this research. The funder and employer were, however, not involved in the design of the study, analysis, and interpretation of the data, or the writing of the findings. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was financially supported by North-West University [masters bursary 32534256].