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

Caillet, Céline; Vickers, Serena; Vidhamaly, Vayouly; Boutsamay, Kem; Boupha, Phonepasith; Zambrzycki, Stephen; Luangasanatip, Nantasit; Lubell, Yoel; Fernández, Facundo M.; Newton, Paul N.

doi:10.1371/journal.pmed.1003747

Cited by 12 publications

(9 citation statements)

References 20 publications

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“…Particularly, implementation of initial field screening using simple, reliable, and fast technologies can be used to expedite post-market surveillance and lower its total cost [ 15 ]. For successful adoption of these technologies, national governments should prioritize passing country-specific legislation to facilitate swift and appropriate response to medicines failing screening tests [ 41 ]. Further research is still needed to fill the gaps in the literature on the capabilities, costs, and benefits of screening technologies to inform post-market surveillance decisions in more LMICs.…”

Section: Discussionmentioning

confidence: 99%

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study

2023

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The prevalence of substandard and falsified medicines in low- and middle-income countries (LMICs) is a major global public health concern. Multiple screening technologies for post-market surveillance of medicine quality have been developed but there exists no clear guidance on which technology is optimal for LMICs. This study examined the return on investment (ROI) of implementing a select number of screening technologies for post-market surveillance of amoxicillin quality in a case study of Kenya. An agent-based model, Examining Screening Technologies using Economic Evaluations for Medicines (ESTEEM), was developed to estimate the costs, benefits, and ROI of implementing screening technologies for post-market surveillance of substandard and falsified amoxicillin for treatment of pediatric pneumonia in Kenya. The model simulated sampling, testing, and removal of substandard and falsified amoxicillin from the Kenyan market using five screening technologies: (1) Global Pharma Health Fund’s GPHF-Minilab, (2) high-performance liquid chromatography (HPLC), (3) near-infrared spectroscopy (NIR), (4) paper analytical devices / antibiotic paper analytical devices (PADs/aPADs), and (5) Raman spectroscopy. The study team analyzed the population impact of utilizing amoxicillin for the treatment of pneumonia in children under age five in Kenya. We found that the GPHF-Minilab, NIR, and PADs/aPADs were similar in their abilities to rapidly screen for and remove substandard and falsified amoxicillin from the Kenyan market resulting in a higher ROI compared to HPLC. NIR and PADs/aPADs yielded the highest ROI at $21 (90% Uncertainty Range (UR) $5-$51) each, followed by GPHF-Minilab ($16, 90%UR $4 - $38), Raman ($9, 90%UR $2 - $21), and HPLC ($3, 90%UR $0 - $7). This study highlights screening technologies that can be used to reduce costs, speed up the removal of poor-quality medicines, and consequently improve health and economic outcomes in LMICs. National medicine regulatory authorities should adopt these fast, reliable, and low-cost screening technologies to better detect substandard and falsified medicines, reserving HPLC for confirmatory tests.

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Section: Discussionmentioning

confidence: 99%

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study

2023

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“…Such spectral variations, influenced by the coatings, can introduce errors during field analysis. 27–30 For instance, an NIR device in that study misclassified augmentin (an amoxicillin and clavulanate combination) as roxithroxyl tablets even though they represent different active ingredients, probably because both types of tablets had the same type of coating. 31…”

Section: Introductionmentioning

confidence: 99%

Mitigating the impact of gelatin capsule variability on detection of substandard and falsified pharmaceuticals with near-IR spectroscopy

Awotunde,

Lu,

Cai

et al. 2024

Anal. Methods

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“…Due to the wide variety of ways that pharmaceutical products can fail quality standards, the combination of several techniques is highly recommended to detect substandard or falsified medicines and to obtain an accurate final answer [8,16,17]. Several authors have combined screening and confirmation methods for the detection of SF medicines [1,[18][19][20][21][22][23][24] and recently, others attempted to evaluate the practical use of different handheld screening tools on the field [25][26][27][28].…”

Section: Introductionmentioning

confidence: 99%

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

et al. 2023

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The negative consequences of Substandard and falsified (SF) medicines are widely documented nowadays and there is still an urgent need to find them in more efficient ways. Several screening tools have been developed for this purpose recently. In this study, three screening tools were used on 292 samples of ciprofloxacin and metronidazole collected in Cameroon. Each sample was then analyzed by HPLC and disintegration tests. Seven additional samples from the nitro-imidazole (secnidazole, ornidazole, tinidazole) and the fluoroquinolone (levofloxacin, ofloxacin, norfloxacin, moxifloxacin) families were analyzed to mimic falsified medicines. Placebo samples that contained only inert excipients were also tested to mimic falsified samples without active pharmaceutical ingredient (API). The three screening tools implemented were: a simplified visual inspection checklist, a low-cost handheld near infrared (NIR) spectrophotometer and paper analytical devices (PADs). Overall, 61.1% of the samples that failed disintegration and assay tests also failed the visual inspection checklist test. For the handheld NIR, one-class classifier models were built to detect the presence of ciprofloxacin and metronidazole, respectively. The APIs were correctly identified in all the samples with sensitivities and specificities of 100%. However, the importance of a representative and up-to-date spectral database was underlined by comparing models built with different calibration set spanning different variability spaces. The PADs were used only on ciprofloxacin samples and detected the API in all samples in which the presence of ciprofloxacin was confirmed by HPLC. However, these PADs were not specific to ciprofloxacin since they reacted like ciprofloxacin to other fluoroquinolone compounds. The advantages and drawbacks of each screening tool were highlighted. They are promising means in the frame of early detection of SF medicines and they can increase the speed of decision about SF medicines in the context of pharmaceutical post-marketing surveillance.

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

Abstract: Céline Caillet and co-authors discuss a Collection on use of portable devices for the evaluation of medicine quality and legitimacy.

Cited by 12 publications

References 20 publications

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study

Mitigating the impact of gelatin capsule variability on detection of substandard and falsified pharmaceuticals with near-IR spectroscopy

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

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