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Quality of medical products for diabetes management: a systematic review
  1. Kartika Saraswati1,2,3,
  2. Chanvilay Sichanh1,
  3. Paul N Newton1,2,3,
  4. Céline Caillet1,2,3
  1. 1Lao-Oxford-Mahosot-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic
  2. 2Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK
  3. 3Infectious Diseases Data Observatory/WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK
  1. Correspondence to Dr Kartika Saraswati; kartika.saraswati{at}ndm.ox.ac.uk

Abstract

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.

  • medicine quality
  • substandard and falsified medicine
  • diabetes

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Handling editor Seye Abimbola

  • Contributors PN, CC and KS designed the review. KS and CS conducted the literature review in English and French, respectively. Screening and extraction were performed by KS under the supervision of CS and CC. KS, CS and CC assessed the quality of surveys. KS performed the analysis under the guidance of PN and CC. KS prepared the first manuscript draft. PN and CC provided revision and guidance on the overall direction of the study. All authors approved the final version for publication.

  • Funding Wellcome Trust of Great Britain MAPQAMP grant 202935/Z/16/Z.

  • Disclaimer The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report.

  • Competing interests CS, PN and CC are supported by the Wellcome Trust.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository. All data relevant to the study are included in the article or uploaded as online supplementary information.

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