A comparative field evaluation of six medicine quality screening devices in Laos.

<h4>Background</h4>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...

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Autores principales:	Céline Caillet, Serena Vickers, Stephen Zambrzycki, Facundo M Fernández, Vayouly Vidhamaly, Kem Boutsamay, Phonepasith Boupha, Pimnara Peerawaranun, Mavuto Mukaka, Paul N Newton
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/1afb9e64b6fc4edfb7e6ec93ff9d31b9
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spelling	oai:doaj.org-article:1afb9e64b6fc4edfb7e6ec93ff9d31b92021-12-02T20:24:00ZA comparative field evaluation of six medicine quality screening devices in Laos.1935-27271935-273510.1371/journal.pntd.0009674https://doaj.org/article/1afb9e64b6fc4edfb7e6ec93ff9d31b92021-09-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009674https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions/significance</h4>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.Céline CailletSerena VickersStephen ZambrzyckiFacundo M FernándezVayouly VidhamalyKem BoutsamayPhonepasith BouphaPimnara PeerawaranunMavuto MukakaPaul N NewtonPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 9, p e0009674 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Céline Caillet Serena Vickers Stephen Zambrzycki Facundo M Fernández Vayouly Vidhamaly Kem Boutsamay Phonepasith Boupha Pimnara Peerawaranun Mavuto Mukaka Paul N Newton A comparative field evaluation of six medicine quality screening devices in Laos.
description	<h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions/significance</h4>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.
format	article
author	Céline Caillet Serena Vickers Stephen Zambrzycki Facundo M Fernández Vayouly Vidhamaly Kem Boutsamay Phonepasith Boupha Pimnara Peerawaranun Mavuto Mukaka Paul N Newton
author_facet	Céline Caillet Serena Vickers Stephen Zambrzycki Facundo M Fernández Vayouly Vidhamaly Kem Boutsamay Phonepasith Boupha Pimnara Peerawaranun Mavuto Mukaka Paul N Newton
author_sort	Céline Caillet
title	A comparative field evaluation of six medicine quality screening devices in Laos.
title_short	A comparative field evaluation of six medicine quality screening devices in Laos.
title_full	A comparative field evaluation of six medicine quality screening devices in Laos.
title_fullStr	A comparative field evaluation of six medicine quality screening devices in Laos.
title_full_unstemmed	A comparative field evaluation of six medicine quality screening devices in Laos.
title_sort	comparative field evaluation of six medicine quality screening devices in laos.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/1afb9e64b6fc4edfb7e6ec93ff9d31b9
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A comparative field evaluation of six medicine quality screening devices in Laos.

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