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The Greater Mekong Subregion must build on current initiatives for a lasting response to fake and substandard drugs, says Charles Delacollette.

Malaria programmes promote artemisinin-based combination therapies (ACT) — powerful, life-saving medicines used to manage malaria — making them available in every country where the disease is endemic.

But parasite resistance to artemisinins has recently emerged on the Cambodia–Thailand border. This was documented by an unusual increase in the time it takes for patients to clear the parasite from their body, and their decreasing susceptibility to ACT.

This has triggered a multi-country response to stop resistance spreading beyond the Greater Mekong Subregion (GMS), and to answer a basic question: why has it surfaced in this particular region?

One of the key driving factors is the availability of medicines of questionable origin and quality — in other words, counterfeit and substandard drugs.

An estimated 20 per cent of all malaria deaths worldwide can be associated directly with the use of such drugs. Although the impact on both mortality and morbidity remains unknown, efforts are underway to detect them, track criminal activity and enforce anti-counterfeiting regulations.

Detecting fakes

In the GMS and beyond, countries have been taking action to trace locally made or imported counterfeits. The first step was to document the magnitude of the problem without relying on rumours and misinformation.

Collaborative studies using forensic analysis of drug samples, for example, have shown that fake artemisinin medicines are circulating widely across and outside South-East Asia. They also suggest that half the artesunate (a drug in the artemisinin group) that circulated in the Mekong region 10 years ago was counterfeit.

The situation has since improved thanks to international epidemiological investigations into trade in fake artesunate, the identification of major counterfeiters, and the subsequent closure of illegal factories that produced counterfeit drugs.

Since 2000, partners in the Mekong Roll Back Malaria Initiative have intensified their malaria interventions in the region.

One of these involves intensive monitoring of antimalarial medicines at different points in their distribution, including private shops and private sellers, and testing their quality against international standards.

The methods vary from simple inspections in the field — looking for labelling faults or whether tablets dissolve as normal, for example — to more sophisticated ones, such as chromatography (a technique that separates chemical mixtures). Building capacity for this type of monitoring has been an essential part of the project. 

Between 2 and 20 per cent of antimalarials failed to meet international quality standards over the past five years. The proportion was highest in remote provinces, where a lack of well-structured healthcare systems means that informal, private clinics are flourishing.

Stronger surveillance systems

Governments have received extra technical and financial support for regulation and law enforcement, including capacity building to monitor imports and the distribution of medicines, vaccines and laboratory reagents.

Thanks to the effort made by the Roll Back Malaria Initiative partners and the WHO, and United States Pharmacopeia in particular, most funding proposals for malaria control supported by the Global Fund To Fight AIDS, Tuberculosis and Malaria now include a strategic component to monitor counterfeits and substandard drugs.

This means that drug regulatory authorities in the affected countries need to strengthen their capacity for surveillance, update their regulatory procedures, and establish simple tracking, reporting and information systems.

On the Cambodia–Thailand border, for example, local authorities identify private pharmacies or shops that sell drugs illegally, destroy drugs that fail to match national regulatory standards, and hand out severe penalties.

These operations are starting to show results. Surveys conducted by various partners coordinated by national programmes, such as ACTWatch, show that fewer counterfeit and substandard antimalarials were marketed in 2010 than in previous years.

The WHO and its partners have also put in place an Internet-based alert mechanism in the Western Pacific Region. Set up in 2001, this aims for the early detection, easy reporting and mapping of potential fake or substandard medicines by official pharmacies and drug outlets.

This could be linked to existing national systems that monitor other hazards, such as food poisoning.

But such a system must function well at a national level first, and this requires more funding. Efforts should also be made to increase public awareness and to encourage users to report incidents.

Good practice

Another priority in the fight against counterfeit drugs is encouraging the production of medicines as part of a global or regional 'good manufacturing practice' framework, which includes a strong post-marketing surveillance system.

The counterfeits market will shrink if we put in place good practices and promote public awareness daily and systematically, and if we better forecast drug shortages to produce high-quality generics.

None of this is easy to do where profit, rather than public health, is the leading motivation. This is particularly difficult in low-income countries without health insurance for the poor, and where the market for drugs is growing and unregulated.

But efforts are being made to engage the private sector in delivering only highly subsidised, high-quality malaria medicines. In Cambodia and some African countries, for example, initiatives such as the Affordable Medicines Facility – Malaria are piloting subsidised mechanisms to make genuine antimalarials available at cost price.

Substantial grants from the Global Fund have also ensured that high-quality ACTs are widely promoted in all Mekong countries. This was not the case a few years ago.

But not all countries participate equally in these operations, so promising results need to be published or documented, with good practices identified and promoted through the media.

Counterfeit drugs can kill, and substandard drugs contribute to fatalities by fuelling resistance. Low-income countries must be helped to mount a long-term response to document the extent of the problem and to tackle the threat with effective tools, regulations and law enforcement.

Charles Delacollette is coordinator of the Mekong Malaria Programme in Bangkok, Thailand.

This article is part of a Spotlight on Detecting counterfeit drugs.

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