Lächele Micha, Gabel Julia, Sunny-Abarikwu Nkiru, Ohazulike Rita Ezinwanne, Ngene Juliet, Chioke Jane Frances, Heide Lutz
Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.
Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria.
J Pharm Policy Pract. 2024 Dec 9;17(1):2432471. doi: 10.1080/20523211.2024.2432471. eCollection 2024.
Substandard and falsified (SF) medicines are a serious threat to public health in low- and middle-income countries (LMICs). Visual inspection of medicines and screening analysis using the Global Pharma Health Fund (GPHF)-Minilab are important in medicine quality surveillance in low-resource settings.
Recently, 260 medicine samples from Nigeria had been investigated for assay and dissolution according to the United States Pharmacopeia (USP). In the present study, these results were compared to the results of the investigation of the same samples by visual inspection and by GPHF-Minilab analysis by local personnel in Nigeria.
Visual inspection identified many deficiencies of dosage units and packaging information in SF medicines. All four falsified medicines were readily identifiable, primarily from serious spelling errors in the labelling, and from manufacturer names which could not be verified using internet resources. In GPHF-Minilab disintegration testing, two samples did not disintegrate even after 60 min; both were found to fail USP dissolution testing with extreme deviations. Of the 20 samples which deviated in USP assay analysis by more than 20% from the declared API amount, seven (35%) were detected as non-compliant in TLC analysis. Evaluation by TLC image analysis with a recently developed smartphone application (named TLCyzer) increased sensitivity to 62.5% but led to an unacceptably low specificity (75.2%). Additional training of the local personnel improved the results of both TLC analysis and TLCyzer evaluation. Photographs of the visual deficiencies and of the TLC analysis results of the SF medicines are provided as PowerPoint and PDF slides with this publication, for future training courses of pharmacy staff and health workers in LMICs.
Visual inspection, and screening analysis with simple, rapid and inexpensive methods, are important in the surveillance for SF medicines in LMICs. This study provides data on the potential and the limitations of such screenings.
劣质和伪造药品对低收入和中等收入国家（LMICs）的公众健康构成严重威胁。药品外观检查以及使用全球药品健康基金（GPHF）-微型实验室进行筛查分析，对于资源匮乏地区的药品质量监测至关重要。
最近，按照美国药典（USP）对来自尼日利亚的260份药品样本进行了含量测定和溶出度调查。在本研究中，将这些结果与尼日利亚当地人员通过外观检查和GPHF-微型实验室分析对相同样本的调查结果进行了比较。
外观检查发现劣质药品在剂型单位和包装信息方面存在许多缺陷。所有四种伪造药品都很容易识别，主要是因为标签上存在严重拼写错误，以及使用互联网资源无法核实的制造商名称。在GPHF-微型实验室崩解试验中，两个样本即使在60分钟后也未崩解；两者均被发现USP溶出度试验不合格，偏差极大。在USP含量分析中与申报的活性成分量偏差超过20%的20个样本中，有7个（35%）在薄层色谱（TLC）分析中被检测为不合格。使用最近开发的智能手机应用程序（名为TLCyzer）进行TLC图像分析评估，灵敏度提高到62.5%，但特异性低至不可接受的75.2%。对当地人员进行额外培训改善了TLC分析和TLCyzer评估的结果。本文以PowerPoint和PDF幻灯片形式提供了劣质药品外观缺陷和TLC分析结果的照片，供LMICs地区药房工作人员和卫生工作者未来培训课程使用。
外观检查以及使用简单、快速且廉价的方法进行筛查分析，对于LMICs地区劣质药品监测至关重要。本研究提供了此类筛查的潜力和局限性的数据。
