Tropical Medicine and International Healthdoi:10.1111/j.1365-3156.2010.02494.x

volume 15 no 5 pp 639–644 may 2010

Prevalence of counterfeit anthelminthic medicines:a cross-sectional survey in Cambodia
Mohiuddin Hussain Khan1, Junko Okumura2, Tey Sovannarith3, Nam Nivanna3, Manabu Akazawa1 andKazuko Kimura1
1 Department of Drug Management and Policy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University,Ishikawa, Japan
2 Department of International Health, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan
3 National Health Product Quality Control Center, Phnom Penh, Cambodia

Summary

objectives To assess the prevalence of counterfeit anthelminthic medicines in Cambodia, and to
determine influential factors.
methods Commonly used anthelminthic medicines were collected from private drug outlets. Medicines were carefully observed including their registration labelling, and their authenticity was investigated with the manufacturers and the Medicines Regulatory Authorities. Samples were analysed byHigh-Performance Liquid Chromatography at the National Health Product Quality Control Centre,
Cambodia.
results Two hundred and three samples of anthelminthics were collected from 137 drug stores.
Domestic products constituted 36.9%. Of 196 samples which were verified for registration, 15.8% were
not registered. Of 165 samples successfully investigated for their authenticity, 7 (4.2%) were identified
as counterfeit. All of these medicines were purchased in open packs or containers, and most of them wereforeign manufactured and ⁄ or without registration.
conclusion The results of our survey urge strict implementation of drug registration and vigilance on
the availability of unregistered medicines to combat counterfeit medicines in Cambodia.
keywords counterfeit drugs, Cambodia, anthelminthics, cross-sectional survey

Introduction
Currently, it is not uncommon for patients to take medicines prescribed by their physician without an improvementof the condition. There could be many reasons for such asituation. In a developing country, one might wonder
whether the medicines are genuine or of good quality. In
severe cases, patients may die as a consequence of poorquality or counterfeit drugs (Hanif et al. 1995; White
1999; Aldhous 2005).
‘A counterfeit medicine is one which is deliberately andfraudulently mislabelled with respect to identity and ⁄ orsource’ (WHO 1999, 2009a; IMPACT 2007). Simply put,counterfeit medicines are imitations of legitimate medicinesthat bear the authorization of appropriate authorities.
Substandard drugs, on the other hand, are legitimate drugs
that do not meet the quality specifications claimed by theirmanufacturers (WHO 2009b). Chemical instability, inappropriate storage and transport, and poor quality controlª 2010 Blackwell Publishing Ltd

during manufacturing may deteriorate drug quality in lessdeveloped countries (Khan & Ghilzai 2007).
The severity of drug counterfeiting has been documented
in a number of reports from different countries. WHO
found that 20–90% of drugs were counterfeited in some
African countries (Surendran 2004; Kelesidis et al. 2007).
In 2005, 12.2% of antimalarials in Tanzania were identified as substandard by content analysis (Kaur et al. 2008).
In southeast Nigeria, 37% of samples did not comply withstandards (Onwujekwe et al. 2009), and similar scenarios
exist in Asia (Newton et al. 2006; Khan & Ghilzai 2007).
Survey findings from the Ministry of Health (MoH),
Cambodia suggest that 10.43% of the drugs in the country
were being counterfeited in 2001 (MOH 2001). In 2004,
the second survey of the MoH, Cambodia, in cooperation
with WHO, reported the prevalence of 21.13% counterfeit
medicines (MOH 2004). In 2006, Lon et al. (2006) found
58% counterfeit and substandard antimalarials in licensed
outlets and 75% in non-licensed outlets.
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