Antimalarials of unproven quality rampant in Africa

Drugs are prepared at the Servants of the Poor dispensary
Copyright: Panos

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  • Researchers assessed distribution of antimalarials in eight countries
  • They found that that drug outlets had more unapproved antimalarials
  • Expert calls for strong regulation and local production of antimalarials

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[NAIROBI] Sub-Saharan Africa  has a large and potentially growing market for non-quality-assured  antimalarials, especially in the private sector, a  study says.

Quality assured antimalarials are drugs certified by global health organisations such as the WHO for treating malaria. They contain the indicated amount of active pharmaceutical ingredient (API) as opposed to poor quality or substandard ones that may not contain the specified amount of API.

According to researchers, because the recommended first-line medicines for treating uncomplicated malaria in Sub-Saharan Africa — also called artemisinin combination therapy —are mainly distributed by the private sector, studies that explore this market are necessary.

Therefore, the study published in the Malaria Journal last month (25 May) examined the extent to which non-quality-assured artemisinin combination therapy (non-QAACT) are available in the private and public sectors in eight malaria endemic countries in Sub-Saharan Africa — Benin, Democratic Republic of the Congo, Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia— between 2009 and 2015.

“The rise of non-QAACT is critical not only to patient health and safety, but also to effective malaria control.”

Kate O’Connell, ACTwatch Group

Trained volunteers conducted a total of 29 malaria medicine outlet surveys in the countries to examine outlets that could possibly stock antimalarials in the public (non-profit) and private-for-profit sectors, during the peak malaria transmission season for each country. In each country, the surveys lasted six to eight weeks.

The researchers screened about 50,000 eligible outlets and audited over 336,000 antimalarials, including more than 78,000 quality-assured ACT and 83,000 non-QAACT— medicines which have not been granted global regulatory approval.

“Private sector availability of non-QAACT varied substantially between countries during the most recent survey round from 0 per cent in Madagascar and 4 per cent in Benin, to 17 per cent in Zambia, 21 per cent in Tanzania, and 38 per cent in Uganda,” notes the paper.  “More than 40 per cent of private sector outlets were stocking non-QAACT in Kenya (42 per cent), and about half of outlets had non-QAACT in stock in Nigeria (48 per cent) and Democratic Republic of Congo’s Katanga (53 per cent).”

Kate O’Connell, the founding principal investigator for ACTwatch Group, which conducted the study, says: “Addressing the availability and distribution of non-QAACT will require effective private sector engagement and evidence-based strategies to address provider and consumer demand for these products.”

O’Connell adds: “The rise of non-QAACT is critical not only to patient health and safety, but also to effective malaria control and protection of artemisinin drug efficacy in the face of spreading resistance.”

Willis Simon Akhwale, Kenya-based malaria control specialist, says that the study covers a long period, and provides an opportunity to do a trend analysis.

Akhwale tells SciDev.Net that the findings could be due to the lack of local manufacturing of antimalarials and high cost of quality antimalarials in Sub-Saharan Africa.

According to Akhwale, the findings do not portend well for the achievements made so far towards malaria control in Africa.

“Most countries in Sub-Saharan Africa have weak regulatory mechanisms,” Akhwale adds, noting that international manufacturers should partner with local manufacturers to produce these medicines.
It may be easier for regulatory authorities to monitor local production than a wide array of imports, Akhwale explains.
The findings, says Akhwale, are important to the ministries of health, national malaria control programs and industrialisation ministries. Participation of local manufacturers and importers is also key.
He is calling for strict regulation by regulatory boards with full support of the government.
This piece was produced by SciDev.Net’s Sub-Saharan Africa English desk.