High proportions of malaria drugs are found to be substandard
TropIKA.net: Medicines for malaria are amongst the drugs most commonly found in counterfeit or substandard form. The first results of a major study in Africa have confirmed the extent of this problem. In Senegal, 44% of antimalarials were found to be substandard. In the two other countries from which data is so far available – Madagascar and Uganda – the percentages of substandard products were 26% and 30% respectively.
The implications are serious – not only are substandard drugs ineffective and sometimes hazardous, they also hasten the development of strains of the malaria parasite that are resistant to the active ingredients.
Ten-country study
The results just released are part of the Quality of Antimalarials in Sub-Saharan Africa (QAMSA) study, a ten-country collaborative project conducted by the World Health Organization (WHO) and the Promoting the Quality of Medicines (PQM) programme. PQM is funded by USAID and implemented by US Pharmacopeial Convention (USP).
In Madagascar, Senegal and Uganda, the study sampled 491 antimalarials, performed basic testing on almost all, and submitted 197 samples to full-scale quality control testing. The focus was on artemisinin-based combination therapy (ACT) products, currently the first-line treatment for uncomplicated malaria, and sulfadoxine-pyrimethamine (SP) products, often used for preventative treatment of malaria during pregnancy. The samples were collected from the public and regulated private sectors in these countries, as well as from informal markets, as many patients obtain their medicines from these sources.
In the QAMSA study “substandard” medicines are defined as those that do not meet the quality specifications set for them, primarily because they do not contain the correct amount of the active ingredient(s), do not dissolve properly in the body or include unacceptable levels of potentially harmful impurities. The results make no distinction between substandard drugs that were made by the company identified as manufacturer on the packaging, or whether they were counterfeits.
An unfortunate picture
Anthony Boni, technical representative for the PQM programme at USAID said: “The results of the study paint a very unfortunate picture of the situation in sub-Saharan Africa. With almost half of medicines in Senegal and more than one out of four medicines in Madagascar and Uganda failing quality testing, clearly much work needs to be done to provide patients with medicines that meet the level of quality they require – and deserve.
“These countries are committed to protecting the health of their citizens, but the authorities face many challenges in regulating their markets. We look forward to working together with them to reduce the morbidity and mortality caused by malaria, by improving the quality of the medicines used to treat this disease.”
Patrick Lukulay, director of the PQM programme at USP said the study offered extremely valuable information, which had already been shared with Senegal, Madagascar and Uganda, regarding products, brands and geographical locations where substandard medicines were found to pose the biggest threats: “These findings can be used immediately by officials to target their efforts – an especially useful approach when resources are scarce, as they are in these countries.”
One particularly interesting finding was that none of the substandard drugs identified was completely lacking in its active ingredient(s).
The results also showed that, as a general rule, when a brand passed or failed in one country, it would also pass or fail in other countries. This indicates that the problem of quality is created at the source, rather than during passage through the distribution chain.
Despite some similarities, results by country varied in a number of areas, including at which points of sale the substandard medicines were found. In Madagascar, for instance, poor quality medicines appear to be widespread across regions and not limited to any particular type of distributor. In Uganda, samples fared much better in the public sector than in the country’s private sector. PQM regards this as “one of the bright spots” in the findings.
A smaller study [1] in Africa published two years ago found a similar proportion of substandard antimalarials in circulation.
Reference
1. Bate R, Coticelli P, Tren R, Attaran A (2008). Antimalarial Drug Quality in the Most Severely Malarious Parts of Africa – A Six Country Study. PLoS ONE 3(5): e2132. Available from: https://www.ncbi.nlm.nih.gov/pubmed/18461128
by Paul Chinnock, TropIKA.net