Sub-standard antimalarial medicines are still sold widely in Madagascar, Senegal, and Uganda, according to a recently published study by United States Pharmacopeia (USP), a non-governmental organization dedicated to monitoring standards and quality of medicines and food around the world.

Dr. Patrick Lukulay, Director of the Promoting the Quality of Medicines (PQM) program at USP described multiple difficulties countries face in the struggle to guarantee access to high quality medicines. Substandard medicines are available because there is a public demand for affordable health options. So the market for substandard medicines continues to thrive as people buy these medicines due to a lack of resources--illicit medicines are sold at lower prices--and due to a lack of access to high quality medical distributors. People living in rural areas do not always have access to a government-regulated distributor, so will buy medicine from informal distributors in their communities. This is particularly problematic for malaria, because it is such a common ailment. Lukulay explained, "If your child has a high fever [one of the initial symptoms of malaria], you're not going to travel one hour to go to the capital city. You're just going to get what's nearest to your home."

In a country like Senegal, with fairly porous borders, people, particularly small-scale entrepreneurs, can import and sell medicine without the government's awareness. At times even large-scale distributors sell substandard medicines. These companies sometimes have links to the government, so even when weaknesses in their products are identified it can be a political battle to withdraw them from the market.

The study, "Survey of the Quality of Selected Antimalarial Medicines Circulating in Madagascar, Senegal, and Uganda", was a partnership between USP, the United States Agency for International Development (USAID), and the World Health Organization (WHO). Veerle Coignez, pharmaceutical management advisor for USAID explained to MediaGlobal: "With this study we are hoping that it will lead to targeted actions based on the samples that were found to be substandard. But beyond that, it will help keep the momentum going of improving the medicines quality assurance systems."

Lack of quality medicines is a public health risk in both the short and long term, and the stated goals of the study were to update and expand the knowledge of sub-standard antimalarials in these countries. When people take substandard medicine they may not effectively treat their disease. Even more worrisome is that, in the long term, the use of substandard medicinces can possibly influence strains of malaria in becoming resistant to drugs, and therefore much more difficult to treat. Formerly effective malarial medicines such as quinine, chloroquine, and sulfadoxine/pyrimethamine have already become obsolete due in part to drug resistance.

The study found that 43 percent of samples in Senegal did not meet all of the tested standards. Uganda had a failure rate of 26 percent, and Madagascar of 30 percent. These are the overall results, but the study also explored which sectors and regions had greater pass or fail rates. For example, in Uganda all of the medicines tested from the public sector, which is to say authorized by the government, were up to standard. The breakdown of the information will be useful for pinpointing the areas that need improvement. Jennifer Murphy, supply chain advisor for the President's Malaria Initiative with USAID specified, "it gives you a kind of snap shot in time of what is available to consumers."

Addressing these issues is a complicated process, and drug regulation requires continuing efforts on the part of national governments. Coignez described the four steps necessary for a functional quality control program. These include first a solid registration system in which the government monitors imported medicines and regularly performs quality control tests before allowing the medicines into the market.

The second element is to license all of the actors in the distribution chain: pharmaceutical stakeholders, manufacturers, distributors, and pharmacies. Third, countries should have in-country quality testing laboratories. Senegal, Uganda, and Madagascar already have government regulatory bodies, but their technical capacity and the scope of their actions must be improved.

The final step is post-marketing surveillance. Coignez emphasized that this is especially important when the other systems are still in development. Post-marketing surveillance is when governments test medicines that consumers are using. When substandard medicines are found in the supply chain they can trace their origins and take action to withdraw the products from the market.

But Coignez underlined that this capacity building and strengthening of the whole medical regulatory system is a complicated and involved process. "It sounds easy; it isn't as easy. It takes a while before countries get it right, before the testing is done correctly, before it's passed on for confirmative testing, before the reporting is done and before actions are taken."

To address the widespread quality issues, Lukulay, like Coignez, suggests strengthening post-market surveillance programs. But in light of the broader social issues of access and affordability, Lukulay also recommends implementing national health insurance programs. When people are paying for medicine out of pocket, they are often forced to choose the less expensive option. On the other hand, if the government subsidized regulated medicines and provided accessible distribution points, people would use high quality medicines. "If people know that they can go there and get the medicines at very reduced price, or next to nothing, then they will not be hesitation to go to the outlets to find these."