SOURCE: The United States Pharmacopeial Convention

The United States Pharmacopeial Convention

April 25, 2011 15:47 ET

USP: On World Malaria Day, Focus on Building Sustainable Capacity to Allow Developing Nations to Determine Their Own Destiny

ROCKVILLE, MD--(Marketwire - Apr 25, 2011) - The United States Pharmacopeial Convention issues the following statement by Dr. Patrick Lukulay:

Today, a diverse community of governments, donor groups, corporations and individuals around the world is commemorating World Malaria Day. There are many parties doing remarkable work to eradicate this treatable disease that takes close to 800,000 lives every year, largely in sub-Saharan Africa. Malaria takes a particularly harsh toll on the most vulnerable members of our society: children. Among those in Africa, one child dies from malaria every 45 seconds. And while progress is being made -- and should be acknowledged today -- we still have a long way to reaching the United Nations' Millennium Development Goal of halting and beginning to reverse the incidence of malaria by 2015.

Malaria is a formidable foe, and now is the time to make sure we are strategically armed for battle. Our arsenal includes multiple interventions such as protective nets, diagnostic tests, indoor sprays and antimalarial medicines. Patient access to antimalarials remains a critical issue, but additional challenges have emerged: What if the medication is not quality assured and services are not in place to ensure adequate distribution, storage and appropriate use? What if donors have to close their doors due to the economy or because they have reached their target spending goals? How can we build sustainable capacity in the most affected communities to help the people living there address these issues on their own?

In many malaria-endemic nations, substandard and counterfeit versions of antimalarial drugs exist in staggering numbers. Among other deficiencies, these products may contain impurities, no active ingredient, or even the wrong active ingredient. For example, some contain only acetaminophen, aiding in fever reduction and thus tricking the patient into thinking that he is being cured of malaria when the fever breaks. Even when the active ingredient is correct, it may be an insufficient quantity, which can affect not only the individual taking the medicine, but also can lead to drug-resistant malaria parasites, thereby affecting a generation of people by making the good medicines ineffective in the long run. We have already lost previous antimalarial therapies due to resistance; currently we only have one effective treatment -- artemisinin combination therapy -- which we cannot afford to lose. Sadly, there is evidence that drug-resistant strains are appearing.

Substandard and counterfeit medicines are widely available in many countries in part due to weak or nonexistent regulatory structures, unsophisticated local manufacturing capacity and poor border controls. To address these issues adequately, those of us working in a donor capacity must assist malaria-ridden nations in Africa, Asia and Latin America to build sustainable capacity to overcome critical constraints in the health system. We must do this by looking at these countries as partners and leaders, and thus must emphasize country ownership and leadership in technical assistance programs.

In my work as director of the Promoting the Quality of Medicines Program, I have learned that we must be more inclusive to make a long-term impact. For instance, we test medicines to determine whether they are of poor quality, but we also conduct training so that government laboratories can test their own medicines. We use cost-effective technology to screen medicines, recognizing resource constraints in nations. We work with local manufacturers on Good Manufacturing Practices, so countries can increase their domestic supply of quality medicines as well as expand internationally, thereby strengthening their economic position.

We have learned the critical importance of working with our counterparts in countries to achieve buy-in and country ownership, building on existing institutions and expertise (in our case, regulatory bodies and quality control laboratories) so as not to create redundant systems. It also is important to coordinate with other donors to maximize impact while minimizing duplication and cost. We need to support local empowerment to allow nations to take care of their own citizens. Philanthropic and public health goals must keep long-term benefits in mind, giving serious consideration to building or strengthening systems rather than simply executing specific activities to meet individual goals. On World Malaria Day, let us flip the traditional donor paradigm on its head. Let us make the shift from commodity-focused to services-focused giving that serves to empower, strengthening existing systems with the shared goal of enabling countries to experience a prosperous future free from this terrible and treatable scourge.

Dr. Patrick Lukulay
Director of the Promoting the Quality of Medicines Program, a cooperative agreement between the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP) to combat poor-quality medicines