Substandard and falsified medicine screening technologies

Abstract

Substandard and falsified medicine screening technologies are invaluable tools for post-marketing surveillance of medicine quality, particularly in low-and middle-income countries. National Regulatory Authorities and their partners leverage screening technologies to detect substandard and falsified medicines in the field and eliminate them from the medical product supply chain. An arsenal of different screening technologies has been developed to evaluate a variety of medicine quality attributes and performance characteristics, applying visual, physical and chemical analyses. Selecting the most effective screening technologies for a given quality challenge requires consideration of several practical, technical, and scientific factors, such as the type of medicines screened, the requirements of the screening technology, and the type of information needed. More widespread adoption of screening technologies will be facilitated by improved workforce development, technological advancements, and the development of a more robust supporting regulatory framework.

Evaluation of portable devices for medicine quality screening: Lessons learnt, recommendations for implementation, and future priorities

“…Standardised guidance on how to assess and compare the performance of screening devices both in the laboratory and field settings and standardised guidelines to report results are urgently needed [ 6 ]. A recent stimulus article from the USP begins to addresses this [ 12 ].…”

“…“Prevention, detection, and response” to SF medical products are strategic priorities of WHO to contribute to effective and efficient regulatory systems [ 4 ]. Numerous portable medicine screening devices are available on the market, holding great hope for detection of SF medicines in an efficient and timely manner, and, therefore, might serve as key detection tools to inform prevention and response [ 5 , 6 ]. Screening devices have the potential to rapidly identify suspected SF medical products, giving more objective selection for reference assays, reducing the financial and technical burden.…”

Blind-Watermarking—Proof-of-Concept of a Novel Approach to Ensure Batch Traceability for 3D Printed Tablets

“…This sealing contains a unique 2D barcode which includes the batch, serial and national identification number, expiry date, and product information [34]. In addition, it is sometimes possible to identify falsified medicines visually (e.g., packaging, labelling, dosage units, watermarks, holograms), physically (discoloration, microscopical investigations of the surface, evaluation of disintegration), or chemically (API assay via spectroscopic, spectrometric, or chromatographic measurements) [30,35].…”

Multiphase evaluation of portable medicines quality screening devices

“…The study aimed to evaluate the accuracy, utility, usability, and cost-effectiveness of different portable devices to identify SF medicines across a variety of essential anti-infective medicines commonly used in the Greater Mekong Sub-region (GMS) to treat malaria and bacterial infections. This project was conducted in parallel with the United States Pharmacopeia Technology Review program [ 13 , 18 , 19 ].…”