Quality of Medical Products for Diabetes Management: a Systematic Review

Background: The global prevalence of diabetes mellitus is increasing alarmingly. However, the quality of vital medicines and medical products used to treat and monitor diabetes remains uncertain but of potential great public health significance. Here, we review the available evidence on the quality of antidiabetic medicines and supplies for self-monitoring of blood glucose (SMBG) and discuss their potential impact for the patients and society.

Methods: Searches were conducted in PubMed, Embase, Google Scholar, Google and relevant websites in English and French. The Medicine Quality Assessment Reporting Guideline (MEDQUARG) was used to assess the quality of medicine quality surveys.

Results: 52 publications on the quality of antidiabetic medicines, including 5 medicine quality prevalence surveys and 20 equivalence studies, were analysed. The prevalence surveys and equivalence studies included 674 samples of which 73 (10.8%) were of poor quality. The median (Q1-Q3) concordance with MEDQUARG items was 30.8% (19.2%-42.3%). No prevalence surveys on SMBG supplies' quality were found, but 29 publications, including falsified products and incorrect results due to strip degradation or contamination, were identified.

Conclusion: There is little accessible evidence on the quality of antidiabetic medicines and SMBG supplies. Surveys were poorly designed and reported, making data aggregation and interpretation problematic. Despite these caveats, these results suggest that there are important issues with the quality of medical products for diabetes that need focused monitoring. There is an urgent need to achieve consensus protocols for designing, conducting and reporting medical product quality surveys.

Prospero Registration Number: CRD42016039841.