Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel
Background 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-resour...
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| Format: | Article |
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Taylor & Francis Group
2024-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/20523211.2024.2432471 |
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| author | Micha Lächele Julia Gabel Nkiru Sunny-Abarikwu Rita Ezinwanne Ohazulike Juliet Ngene Jane Frances Chioke Lutz Heide |
| author_facet | Micha Lächele Julia Gabel Nkiru Sunny-Abarikwu Rita Ezinwanne Ohazulike Juliet Ngene Jane Frances Chioke Lutz Heide |
| author_sort | Micha Lächele |
| collection | DOAJ |
| description | Background 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.Methods 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.Results 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.Conclusion 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. |
| format | Article |
| id | doaj-art-e6b68e64a601468bba64977ed4655cc1 |
| institution | Kabale University |
| issn | 2052-3211 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj-art-e6b68e64a601468bba64977ed4655cc12024-12-09T09:59:35ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112024-12-0117110.1080/20523211.2024.2432471Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnelMicha Lächele0Julia Gabel1Nkiru Sunny-Abarikwu2Rita Ezinwanne Ohazulike3Juliet Ngene4Jane Frances Chioke5Lutz Heide6Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, GermanyPharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, GermanyFaith-Based Central Medical Foundation (FBCMF), Enugu, NigeriaFaith-Based Central Medical Foundation (FBCMF), Enugu, NigeriaFaith-Based Central Medical Foundation (FBCMF), Enugu, NigeriaFaith-Based Central Medical Foundation (FBCMF), Enugu, NigeriaPharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, GermanyBackground 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.Methods 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.Results 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.Conclusion 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.https://www.tandfonline.com/doi/10.1080/20523211.2024.2432471Substandard medicinesfalsified medicinesGPHF-Minilabthin-layer chromatographyvisual inspectionTLCyzer |
| spellingShingle | Micha Lächele Julia Gabel Nkiru Sunny-Abarikwu Rita Ezinwanne Ohazulike Juliet Ngene Jane Frances Chioke Lutz Heide Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel Journal of Pharmaceutical Policy and Practice Substandard medicines falsified medicines GPHF-Minilab thin-layer chromatography visual inspection TLCyzer |
| title | Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel |
| title_full | Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel |
| title_fullStr | Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel |
| title_full_unstemmed | Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel |
| title_short | Screening for substandard and falsified medicines in Nigeria using visual inspection and GPHF-Minilab analysis: lessons learnt for future training of health workers and pharmacy personnel |
| title_sort | screening for substandard and falsified medicines in nigeria using visual inspection and gphf minilab analysis lessons learnt for future training of health workers and pharmacy personnel |
| topic | Substandard medicines falsified medicines GPHF-Minilab thin-layer chromatography visual inspection TLCyzer |
| url | https://www.tandfonline.com/doi/10.1080/20523211.2024.2432471 |
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