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Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method.
Malar J. 2019 Dec 05; 18(1):403.MJ

Abstract

BACKGROUND

The influx of substandard and falsified medicines is a global public health challenge and its rapid detection is a key solution to the menace. This study used three screening methods and one confirmatory method for the quality assessment of 25 batches of artemether/lumefantrine dosage forms from the Ghanaian market to test that combined screening methods only can rapidly detect substandard and/or falsified medicines in areas where confirmatory methods may not be available.

METHODS

The quality of artemether/lumefantrine tablet products obtained from pharmacies and licensed chemical seller shops within the Accra metropolis in Ghana were analysed using three screening methods (GPHF Minilab, Colorimetry and Counterfeit Drug Indicator) and one confirmatory method (high-performance liquid chromatography).

RESULTS

The results showed that 18/25 batches of the artemether/lumefantrine samples passed using the combined screening and confirmatory methods and 5/25 batches of the artemether/lumefantrine samples failed using the combined screening and confirmatory methods. However, 1/25 batch of the artemether/lumefantrine samples failed using the combined screening methods but passed using the confirmatory method. Also, 1/25 batch of the artemether/lumefantrine samples passed using the combined screening methods but failed using the confirmatory method. This notwithstanding, the combined screening methods and the confirmatory method provided equivalent quality assessment profiles for 23/25 (92%) batches of the artemether/lumefantrine tablet products. Out of the 6 samples that failed the confirmatory test, 1/6, 2/6, and 3/6 failed on the high (> 110%), low (< 90%), and no active ingredient (0%), respectively. The sensitivity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 0.5 ± 0.57, 0.83 ± 0.33, 0.75 ± 0.49, and 0.83 ± 0.33, respectively. Also, the specificity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 1.00, 0.95 ± 0.10, 1.00, and 0.95 ± 0.10, respectively.

CONCLUSION

The combined screening methods may be used for rapid detection of falsified and/or substandard medicines without using a confirmatory method. However, additional research on the best combinations of screening devices/methods to rapidly detect the quality of medicines is recommended.

Authors+Show Affiliations

Department of Pharmaceutical Chemistry, School of Pharmacy, University of Ghana, Accra, Ghana. kfopuni@ug.edu.gh.Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Accra, Ghana.Department of Pharmaceutical Chemistry, School of Pharmacy, University of Ghana, Accra, Ghana.Department of Pharmaceutical Chemistry, School of Pharmacy, University of Ghana, Accra, Ghana.Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Accra, Ghana.Apotheke Doc Morris, Avantisalle 152, 6422 RA, Heerlen, The Netherlands.Laboratory Services Department, Food and Drugs Authority, Accra, Ghana.Laboratory Services Department, Food and Drugs Authority, Accra, Ghana.Department of Pharmacology and Toxicology, School of Pharmacy, University of Ghana, Accra, Ghana.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31805937

Citation

Opuni, Kwabena Frimpong-Manso, et al. "Usefulness of Combined Screening Methods for Rapid Detection of Falsified And/or Substandard Medicines in the Absence of a Confirmatory Method." Malaria Journal, vol. 18, no. 1, 2019, p. 403.
Opuni KF, Nettey H, Larbi MA, et al. Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method. Malar J. 2019;18(1):403.
Opuni, K. F., Nettey, H., Larbi, M. A., Amartey, S. N. A., Nti, G., Dzidonu, A., Owusu-Danso, P., Owusu, N. A., & Nyarko, A. K. (2019). Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method. Malaria Journal, 18(1), 403. https://doi.org/10.1186/s12936-019-3045-y
Opuni KF, et al. Usefulness of Combined Screening Methods for Rapid Detection of Falsified And/or Substandard Medicines in the Absence of a Confirmatory Method. Malar J. 2019 Dec 5;18(1):403. PubMed PMID: 31805937.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method. AU - Opuni,Kwabena Frimpong-Manso, AU - Nettey,Henry, AU - Larbi,Marvin Adjei, AU - Amartey,Salome Naa Amerley, AU - Nti,Gifty, AU - Dzidonu,Abraham, AU - Owusu-Danso,Patrick, AU - Owusu,Nicholas Amoah, AU - Nyarko,Alexander Kwadwo, Y1 - 2019/12/05/ PY - 2019/09/13/received PY - 2019/11/29/accepted PY - 2019/12/7/entrez PY - 2019/12/7/pubmed PY - 2020/4/9/medline KW - Anti-malarial KW - Falsified medicines KW - Screening and confirmatory methods KW - Substandard medicines SP - 403 EP - 403 JF - Malaria journal JO - Malar J VL - 18 IS - 1 N2 - BACKGROUND: The influx of substandard and falsified medicines is a global public health challenge and its rapid detection is a key solution to the menace. This study used three screening methods and one confirmatory method for the quality assessment of 25 batches of artemether/lumefantrine dosage forms from the Ghanaian market to test that combined screening methods only can rapidly detect substandard and/or falsified medicines in areas where confirmatory methods may not be available. METHODS: The quality of artemether/lumefantrine tablet products obtained from pharmacies and licensed chemical seller shops within the Accra metropolis in Ghana were analysed using three screening methods (GPHF Minilab, Colorimetry and Counterfeit Drug Indicator) and one confirmatory method (high-performance liquid chromatography). RESULTS: The results showed that 18/25 batches of the artemether/lumefantrine samples passed using the combined screening and confirmatory methods and 5/25 batches of the artemether/lumefantrine samples failed using the combined screening and confirmatory methods. However, 1/25 batch of the artemether/lumefantrine samples failed using the combined screening methods but passed using the confirmatory method. Also, 1/25 batch of the artemether/lumefantrine samples passed using the combined screening methods but failed using the confirmatory method. This notwithstanding, the combined screening methods and the confirmatory method provided equivalent quality assessment profiles for 23/25 (92%) batches of the artemether/lumefantrine tablet products. Out of the 6 samples that failed the confirmatory test, 1/6, 2/6, and 3/6 failed on the high (> 110%), low (< 90%), and no active ingredient (0%), respectively. The sensitivity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 0.5 ± 0.57, 0.83 ± 0.33, 0.75 ± 0.49, and 0.83 ± 0.33, respectively. Also, the specificity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 1.00, 0.95 ± 0.10, 1.00, and 0.95 ± 0.10, respectively. CONCLUSION: The combined screening methods may be used for rapid detection of falsified and/or substandard medicines without using a confirmatory method. However, additional research on the best combinations of screening devices/methods to rapidly detect the quality of medicines is recommended. SN - 1475-2875 UR - https://www.unboundmedicine.com/medline/citation/31805937/Usefulness_of_combined_screening_methods_for_rapid_detection_of_falsified_and/or_substandard_medicines_in_the_absence_of_a_confirmatory_method_ DB - PRIME DP - Unbound Medicine ER -