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.
Original language | English |
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Article number | e000725 |
Journal | BMJ Global Health |
Volume | 3 |
Issue number | 4 |
DOIs | |
State | Published - Jul 2018 |
Externally published | Yes |
Funding
Funding This work is funded under the work programme of the Regional Malaria We are very grateful to the directors of Mahosot Hospital, the Director, Dr Manivanh Vongsouvath, and staff of the Microbiology Laboratory, Mahosot Hospital, all the developers/authors who responded to our queries regarding the devices and studies, and colleagues at the US Pharmacopeial Convention. We thank Dr Douglas Ball, Dr Susann Roth and Dr Sonalini Khetrapal for their support and advice. We also thank the reviewers of this paper for their useful feedback.
Funders | Funder number |
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Regional Malaria | |
United States Pharmacopeia | |
Microbiology Society |