PRELIMINARY SURVEY OF COUNTERFEITING OF ALBENDAZOLE AND METRONIDAZOLE MARKETED IN LUBUMBASHI

Authors

  • Pierrot Mwamba T. Laboratory of galenic pharmacy and drug analysis, University of Lubumbashi, Lubumbashi, Democratic Republic of Congo
  • Pierre Duez
  • Jean Baptiste Kalonji N.

Keywords:

Medicines, counterfeiting, antiparasitics, DRC, Lubumbashi

Abstract

Objective: Counterfeit medicines represent a major health risk in the treatment of various pathologies. They are responsible for resistance emergence in the treatment of infectious diseases. This study was conducted in order to identify illegal and legal drugs marketed in the city of Lubumbashi and assess the quality of all samples concerned by this study.

Methods: The study included albendazole and metronidazole for oral administration. Visual inspection of medicines, investigation of the authenticity of drugs from pharmaceutical regulatory authorities, and determination of content were used as study parameters.

Results: A total of 34 samples were collected including 19 of albendazole and 15 of metronidazole. 11 (32%) samples were not permitted to be marketed. 9 (26 %) samples were substandard according to the US Pharmacopoeia in terms of the content of active ingredient: all of them, the active ingredient was found to present in a lower amount (under-dosing). The proportion of non-compliance is highest among medicines not permitted to be marketed (78% vs 8.0%; p˂0.005).

Conclusion: It is obvious that strengthening the capacity of drug regulatory authority of the DR Congo can reduce the influx of counterfeit/substandard drugs in Lubumbashi.

Keywords: Medicines, Counterfeiting, Antiparasitics, DR Congo, Lubumbashi

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References

Dégardin D, Roggo Y, Margot P. Understanding and fighting the counterfeit medicine market. J Pharm Biomed Anal 2014;87:167-75.

Blackstone EA, Fuhr JP, Pociask SMA. The health and economic effect of counterfeit drugs. Am Health Drug Benefits 2014;7:216-24.

Wilczynski S. The use of dynamic thermal analysis to distinguish between genuine and counterfeit drugs. Int J Pharm 2015;490:16-21.

Fernandez FM, Green MD, Newton PN. Prevalence and detection of counterfeit pharmaceuticals: a mini review. Ind Eng Chem Res 2008;47:585-90.

Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci 2011;11:4571-9.

Almuzaini T, Choonara I, Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. Br Med J 2013;3:e002923. Doi:10.1136/bmjopen-2013-002923. [Article in Press]

Mustafa AO. Assessment of the substandard drugs in developing countries: The impact of the pharmaceutical regulation on the quality of medicines on the sudanese market importers perspective. Pharm Biol Evaluations 2015;2:1-10.

El-Jardali F, Akl EA, Fadlallah R, Olivier S, Saleh N, El-Bawab L, et al. Interventions to combat or prevent drug counterfeiting: a systematic review. Br Med J 2015;5:e006290. Doi:10.1136/ bmjopen-2014-006290. [Article in Press]

OMS. Medicines regulatory authorities: current status and he way forward. Regional committee for Africa; 2006. Available from: http://apps.who.int/iris/handle/10665/92649. [Last accessed on 10 Feb 2016].

Barbereau S. La contrefaçon des médicaments: un phénomène en pleine expansion. Med Trop 2006;66:529-32.

Delepierre A, Gayot A, Carpentier A. Update on counterfeit antibiotic worldwide: public health risks. Med Mal Infect 2012;42:247-55.

Kelesidis T, Kelesidis I, Rafailidis IP, Falagas ME. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother 2007;60:214-6.

Kelesidis T, Falagas ME. Substandard/Counterfeit antimicrobial drugs. Clin Microbiol Rev 2015;28:443-64.

Kindenge MJ, Nsangu MJ, Maghe E, Kobo S, Mwanda R. Application of total error strategy invalidation of affordable and accessible UV-Visible spectrophotometric methods for quality control of poor medicines. Am J Anal Chem 2015;6:106-17.

Aka E, Legris C, Tanimoto T, Matsushita R, Kimura K. Counterfeit medicine detection by authenticity investigation: a pilot study in the street market of Côte d’Ivoire. Jpn J Soc Pharm 2005;24:7–16.

Mussa H, Sule YZ, Gwarzo MS. Assessment of physicochemical properties of metronidazole tablets marketed in Zaria. Int J Pharm Pharm Sci 2011;3:27-29.

WHO. Counterfeit drugs, Guidelines for the development of a measure to combat counterfeit drugs. Departement of essential drugs and other medecines. Geneva, Switzerland. Available from: http://apps.who.int/iris/bitstream/10665/65892/1/ WHO_EDM_QSM_99.1.pdf. [Last accessed on 10 Feb 2016].

Tella AC, Olabemiwo OM, Salawi MO, Obiyenwa GK. Developing a spectrophotometric method for the estimation of albendazole in solid and suspension forms. Int J Pharm Sci 2010;5:379-82.

Khail MH, Hatanaka K, Sovanarith T, Nivanna N, Cadena LC, Yoshida N, et al. effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid-an analysis of Cambodian samples. Pharmacol Toxicol 2013;14:33-45.

Newton P, Proux S, Green M, Smithuis F, Rzendaal J, Prakongpan S, et al. Fake artesunate in southeast Asia. Lancet 2001;357:1948-50.

United state Pharmacopeia national formulary 38. Monograph: Albendazole, volume II; 2009. p. 2065-7.

United State Pharmacopeia national formulary 38. Monograph: Metronidazole, volume III; 2015. p. 4380-6.

Newton PN, Tabernero P, Dwivedi P. Falsified medicines in Africa: all talk no action. Lancet Glob Health 2014;2:e509–10.

Published

01-07-2016

How to Cite

T., P. M., P. Duez, and J. B. K. N. “PRELIMINARY SURVEY OF COUNTERFEITING OF ALBENDAZOLE AND METRONIDAZOLE MARKETED IN LUBUMBASHI”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 7, July 2016, pp. 282-7, https://innovareacademics.in/journals/index.php/ijpps/article/view/11855.

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