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Access to safe and reliable medicines needed

29 Ene 2015
WWARN Published Date

The distribution of falsified or substandard medicines is a serious concern for international public health; it threatens the lives of millions and many years of investment in increasing global access to essential medicines. Poor quality medicines can cause avoidable morbidity, mortality, increased drug resistance and loss of faith within health systems, especially in lower and middle income countries. This problem has been particularly studied with respect to antimalarials.

In a study published by the Lancet Global Health, supported by WWARN and other collaborating institutes, researchers discuss the analysis of medicines confiscated by authorities in Angola in a very large seizure of 1.4 million packets; this huge shipment contained two different falsified medicines. One of the medicines was a falsified version of the widely used antimalarial, artemether-lumefantrine, which was found to contain no artemether, lumefantrine or any other active pharmaceutical ingredient that could be used to treat malaria infection in patients.

Another medicine was labelled as the de-worming medicine mebenadazole but the analysis showed that it contained levamisole, another anti-worm medicine mostly withdrawn from the market due to serious side effects including bone marrow failure and the depletion of white blood cells critical to human immunity. If these falsified medicines had entered the patient supply chain, patients would have failed treatment, and faced prolonged sickness and possible death.

Administering falsified antimalarials, containing no antimalarial, does not itself cause antimalarial resistance, as the parasites are not exposed to any medicine in the blood. However, patients in areas of poor medicine quality when they remain ill, they may seek different medicines until their symptoms are relieved.  If they then take substandard antimalarials, caused by production errors and usually containing less than the stated amount of antimalarial, this may create a perfect environment for resistant parasites to persist in the blood stream, multiply and go on to reinfect other patients.  This combination of both falsified and substandard drugs is likely to be a key driver for further resistance and, if left unchecked, it could threaten the lives of millions.

 “Our analysis highlights many of the policy tribulations that are consequences of failing to regulate medicines globally,”says Prof Paul Newton, lead author of the study and Director of the Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit and Head of Antimalarial Quality at WWARN. “In order to respond to such issues, we need to facilitate collaboration between authorities including governments, pharmaceutical companies, health care professionals, and research institutes. We need to empower Medicine Regulatory Authorities with functional reporting, tracking and enforcement capabilities to stop the criminal trade in falsified medicines.”

A previous study from Prof Newton and his team investigated the scale and severity of falsified and substandard antimalarial drugs. They found that 30 per cent of all antimalarial medicines tested failed either chemical or packaging quality tests. Of the drugs that failed tests, more than 39 per cent were classified as being falsified, 2.3 per cent as substandard and more than 58 per cent were classified as of ‘poor quality’ without sufficient evidence available to classify them as either falsified or substandard.

Poor medicine quality is not restricted to antimalarial treatments, but is a highly underrated universal global health burden. The authors suggest that the public health community must tackle the criminality that lies at the heart of falsified medicine production. They suggest that an international public health convention enshrined in international law could, together with a large-scale financing mechanism, support the multiple countries that are dealing with insufficient capacity to control medicine quality.

Addressing the critical gap in our knowledge of the overall quality of antimalarial treatments, the WWARN Antimalarial Quality (AQ) Surveyor supports efforts of national and international organisations working to provide malaria patients with quality-assured, effective medicines. The AQ Surveyor, recently launched in French as well as in English, delivers customised summaries of published reports of antimalarial drug quality, displaying geographical distribution across regions and over time.

Laboratories in the regions most affected often lack the resources needed to analyse drug samples and screen suspect medicines. The WWARN Antimalarial Quality Group and The Quality Assurance / Quality Control teams together provide a platform to share expertise and collate information to increase understanding of the prevalence and distribution of poor-quality antimalarials, and improve clinical trial data, around the world.

However, it is clear that effective response to the broader spectrum of challenges discovered in Angola and elsewhere, will require more coordinated and concerted international effort.  National regulatory systems and  comprehensive and up-to-date global system for reporting, assessing and appropriately disseminating the information will require support to identify and prosecute those engaged in the distribution of poor quality medicines.

 “Poor-quality medicines, whether substandard or falsified due to fraud, have far reaching consequences,” says Dr Ravinetto, Head of the Clinical Trials Unit, and Member of the Steering Committee of QUAMED, at the Institute of Tropical Medicine in Antwerp. “The seizure of these falsified medicines in Angola illustrates the major obstacles to improving the access to safe and reliable medicines.”

WWARN is actively seeking to develop partnerships with other organisations collecting data on antimalarial drug quality. To find out how you can become involved, contact wwarn@wwarn.org

Newton et al. Falsified medicines in Africa and public health – ‘No Action-Talk only’. The Lancet Global Health, (2014); doi:10.1016/S2214-109X(14)70279-7 (accessed online 28 August)

Access the AQ Surveyor in English and en français

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