1. Evaluation of portable devices for medicine quality screening: lessons learnt, recommendations for implementation and future priorities
- Author
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Céline, Caillet, Serena, Vickers, Stephen, Zambrzycki, Facundo M, Fernández, Vayouly, Vidhamaly, Kem, Boutsamay, Phonepasith, Boupha, Pimnara, Peerawaranun, Mavuto, Mukaka, and Paul N, Newton
- Subjects
Viral Diseases ,Research Facilities ,Economics ,Libraries ,Drug Evaluation, Preclinical ,Social Sciences ,Pilot Projects ,Economic Geography ,Information Centers ,Global Health ,Geographical Locations ,Medical Conditions ,Anti-Infective Agents ,Medicine and Health Sciences ,Public and Occupational Health ,Spectrometers ,Geography ,Substandard Drugs ,Editorial ,Infectious Diseases ,Laos ,Engineering and Technology ,Low and Middle Income Countries ,Research Laboratories ,Research Article ,Biotechnology ,Quality Control ,Asia ,Cost-Effectiveness Analysis ,Visual Inspection ,Equipment ,Bioengineering ,Dermatology ,Research and Analysis Methods ,Sensitivity and Specificity ,Chemistry Techniques, Analytical ,Industrial Engineering ,Blisters ,Humans ,Measurement Equipment ,Pharmacology ,Drug Screening ,Biology and Life Sciences ,Covid 19 ,Economic Analysis ,Pilots ,Counterfeit Drugs ,People and Places ,Earth Sciences ,Medical Devices and Equipment ,Preventive Medicine ,Government Laboratories - Abstract
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, Author summary Substandard and falsified (SF) medicines threaten the lives of millions of people, especially where pharmaceutical legislation and regulation are limited. Screening for SF medicines in supply chains (‘post-market surveillance’) by medicine inspectors is crucial but currently relies only on subjective visual inspection of medicines in most countries. Many innovative portable screening technologies now exist and could be key additional assets to the current practice, but none have been extensively evaluated for medicine quality post-market surveillance. We assessed the utility and usability of six screening devices in the hands of Lao medicines inspectors in a pharmacy constructed to resemble a Lao pharmacy. Five spectrometers showed promising accuracies to identify falsified medicines, but difficulties to correctly set them up before running tests were observed. Reading and interpreting colour barcodes of the ‘paper analytical cards’–a lab-on-a-chip test by inspectors were difficult, leading to lower accuracy than with spectrometers. The study suggests that overconfidence in devices may cause harm by reducing inspectors’ investment in visual inspection—a crucial step to identify falsified medicines. Advantages/limitations of the devices are also documented to inform policy.
- Published
- 2021