Counterfeit antimalarials in Africa on the rise, caution scientists

An international team of researchers is recommending "multiple parallel strategies" to stave off an alarming rise in counterfeit and substandard antimalarials reported in Africa, according to a study published in Malaria Journal.

They warn that a lack of action will lead to serious public health implications.

Among other actions, the researchers are calling for increased co-operation between medicines regulatory agencies, police, customs, malaria control programmes, pharmaceutical companies and international organisations to combat trade in counterfeit medicines.

In addition, they suggest that drug inspectors could use new portable and rapid screening techniques, based on Raman and Near-Infrared (NIR) spectroscopy, to screen pharmacy stock for poor quality medicines. These techniques have already been useful in rooting out imports of counterfeit artemisinin-based combination therapy (ACT). 

Investment in African medicines regulatory authorities and quality-assured laboratories is vital, too. According to the study, the World Health Organization (WHO) estimates that about 30 per cent of countries – "presumably economically poor and malarious" – have little or no drug regulation, meaning most interventions to improve medicine quality "are doomed".

Moreover, a lack of objective data on the epidemiology of poor quality antimalarials makes it difficult to prioritise interventions.

The researchers further point out in the paper that the use of poor quality medicines in clinical trials may skew results. As such, they call for mandatory testing of such medicines, ideally at WHO-prequalified laboratories.

The spread of artemisinin resistance in Africa must be addressed immediately. There is an urgent need to step up investment to ensure ACT quality and the removal of artemisinin monotherapies, which can lead to resistance.

"Unless action is taken quickly, poor ACT quality and profligate use of monotherapy (whether genuine or poor quality) will contribute to the failure of ACT," the study notes.

The researchers examined seven sets of antimalarials of suspicious quality, which were collected from 2002-2012 in 11 African countries.

They found counterfeit artesunate containing chloroquine, counterfeit dihydroartemisinin (DHA) containing paracetamol (acetaminophen), counterfeit DHA-piperaquine containing sildenafil, counterfeit artemether-lumefantrine containing pyrimethamine, counterfeit halofantrine containing artemisinin, and substandard/counterfeit or degraded artesunate and artesunate+amodiaquine. Unexpected active ingredients found in counterfeits further exacerbate the risks to public health.

The study follows a review published in the New England Journal of Medicine in September 2011, which called for large-scale collaboration on measures to address the problem of counterfeit antimalarials such as drug quality monitoring, regulating drug supplies and awareness-raising.