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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A comparative field evaluation of six medicine quality screening devices in Laos
PLoS Neglected Tropical Diseases, Volume 15, No. 9, Article e0009674, Year 2021
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Description
Background Medicine quality screening devices hold great promise for post-market surveillance (PMS). However, there is little independent evidence on their field utility and usability to inform policy decisions. This pilot study in the Lao PDR tested six devices’ utility and usability in detecting substandard and falsified (SF) medicines. Methodology/principal findings Observational time and motion studies of the inspections by 16 Lao medicine inspectors of 1) the stock of an Evaluation Pharmacy (EP), constructed to resemble a Lao pharmacy, and 2) a sample set of medicines (SSM); were conducted without and with six devices: Four handheld spectrometers (two near infrared: MicroPHAZIR RX, NIR-S-G1 & two Raman: Progeny, Truscan RM); one portable mid-infrared spectrometer (4500a), and single-use paper analytical devices (PAD). User experiences were documented by interviews and focus group discussions. Significantly more samples were wrongly categorised as pass/fail with the PAD compared to the other devices in EP inspections (p<0.05). The numbers of samples wrongly classified in EP inspections were significantly lower than in initial visual inspections without devices for 3/6 devices (NIR-S-G1, MicroPHAZIR RX, 4500a). The NIR-S-G1 had the fastest testing time per sample (median 93.5 sec, p<0.001). The time spent on EP visual inspection was significantly shorter when using a device than for inspections without devices, except with the 4500a, risking missing visual clues of samples being SF. The main user errors were the selection of wrong spectrometer reference libraries and wrong user interpretation of PAD results. Limitations included repeated inspections of the EP by the same inspectors with different devices and the small sample size of SF medicines. Conclusions/significance This pilot study suggests policy makers wishing to implement portable screening devices in PMS should be aware that overconfidence in devices may cause harm by reducing inspectors’ investment in visual inspection. It also provides insight into the advantages/limitations of diverse screening devices in the hands of end-users. © 2021 Caillet et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s002.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s003.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s004.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s005.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s006.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s007.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s008.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s009.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s010.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s011.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s012.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s013.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s014.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s015.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC8483322/bin/pntd.0009674.s016.docx
Authors & Co-Authors
Caillet, Céline
Thailand
Mahosot Hospital, Lao
United Kingdom, Oxford
University of Oxford
United Kingdom, Oxford
Worldwide Antimalarial Resistance Network
Thailand, Nakhon Pathom
Mahidol University
Fernández, Facundo M.
United States, Atlanta
Georgia Institute of Technology
Peerawaranun, Pimnara
Thailand, Nakhon Pathom
Mahidol University
Mukaka, Mavuto F.J.
United Kingdom, Oxford
University of Oxford
Thailand, Nakhon Pathom
Mahidol University
Newton, Paul N.
Thailand
Mahosot Hospital, Lao
United Kingdom, Oxford
University of Oxford
United Kingdom, Oxford
Worldwide Antimalarial Resistance Network
Thailand, Nakhon Pathom
Mahidol University
Statistics
Citations: 13
Authors: 5
Affiliations: 5
Identifiers
Doi:
10.1371/journal.pntd.0009674
ISSN:
19352727
Research Areas
Health System And Policy
Study Approach
Qualitative