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

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 substan...

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Veröffentlicht in:PLoS neglected tropical diseases 2021-09, Vol.15 (9), p.e0009674
Hauptverfasser: Caillet, Céline, Vickers, Serena, Zambrzycki, Stephen, Fernández, Facundo M, Vidhamaly, Vayouly, Boutsamay, Kem, Boupha, Phonepasith, Peerawaranun, Pimnara, Mukaka, Mavuto, Newton, Paul N
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Sprache:eng
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Zusammenfassung: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. 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
ISSN:1935-2735
1935-2727
1935-2735
DOI:10.1371/journal.pntd.0009674