Article Text
Abstract
Background Poor quality medicines have devastating consequences. A plethora of innovative portable devices to screen for poor quality medicines has become available, leading to hope that they could empower medicine inspectors and enhance surveillance. However, information comparing these new technologies is woefully scarce.
Methods We undertook a systematic review of Embase, PubMed, Web of Science and SciFinder databases up to 30 April 2018. Scientific studies evaluating the performances/abilities of portable devices to assess any aspect of the quality of pharmaceutical products were included.
Results Forty-one devices, from small benchtop spectrometers to ‘lab-on-a-chip’ single-use devices, with prices ranging from <US$10 to >US$20 000, were included. Only six devices had been field-tested (GPHF-Minilab, CD3/CD3+, TruScan RM, lateral flow dipstick immunoassay, CBEx and Speedy Breedy). The median (range) number of active pharmaceutical ingredients (APIs) assessed per device was only 2 (1–20). The majority of devices showed promise to distinguish genuine from falsified medicines. Devices with the potential to assay API (semi)-quantitatively required consumables and were destructive (GPHF-Minilab, PharmaChk, aPADs, lateral flow immunoassay dipsticks, paper-based microfluidic strip and capillary electrophoresis), except for spectroscopic devices. However, the 10 spectroscopic devices tested for their abilities to quantitate APIs required processing complex API-specific calibration models. Scientific evidence of the ability of the devices to accurately test liquid, capsule or topical formulations, or to distinguish between chiral molecules, was limited. There was no comment on cost-effectiveness and little information on where in the pharmaceutical supply chain these devices could be best deployed.
Conclusion Although a diverse range of portable field detection devices for medicines quality screening is available, there is a vitally important lack of independent evaluation of the majority of devices, particularly in field settings. Intensive research is needed in order to inform national medicines regulatory authorities of the optimal choice of device(s) to combat poor quality medicines.
- other diagnostic or tool
- control strategies
- public health
- screening
- systematic review
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Footnotes
Handling editor Seye Abimbola
Contributors All the authors were involved in the conceptualisation and methodology of the study. CC, SV and MB designed the data collection tool. CC, SV, SZ and MB were responsible for the formal analysis and investigation. CC, SV and MB were responsible for the original draft preparation. FMF and PNN were involved in the supervision. All the authors equally contributed to the reviewing and editing of the manuscript.
Funding This work is funded under the work programme of the Regional Malaria and Other Communicable Disease Threats Trust Fund (RMTF), which was set up at the Asian Development Bank in December 2013, with the specific remit to support low-income and middle-income member countries to develop multicountry, cross-border and multisector responses to urgent malaria and other communicable disease issues. The RMTF’s financing partners are the Government of Australia (Department of Foreign Affairs and Trade), the Government of Canada (Department of Foreign Affairs, Trade and Development), and the Government of the United Kingdom (Department for International Development). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The Wellcome Trust also funded CC, SV and PNN.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data available.