President’s Malaria Initiative increases vigilance, global response to combat counterfeit antimalarial drugs

Report
from US Agency for International Development
Published on 30 May 2013

The President’s Malaria Initiative (PMI) is greatly concerned by the scourge of counterfeit and substandard drugs, and is increasing its financial and programmatic support to technical and regulatory capacities in partner countries. PMI is also urging greater international cooperation on the issue.

The U.S. Government strongly condemns the proliferation of counterfeit medicines. One of the most insidious threats to continued progress in malaria is the potential for substandard or counterfeit/falsified drugs to infiltrate partner country supply chains in both the public and private sectors leading to dire consequences such as ineffective treatment of disease, severe adverse reactions in patients, development of resistance and death.

PMI is committed to ensuring that all persons with malaria are promptly diagnosed and treated with a safe and efficacious antimalarial drug. PMI takes all reports of suspect counterfeits and illegal diversion [PDF, 60.6KB] seriously.

As noted in the Wall Street Journal “Africa's Malaria Battle: Fake Drug Pipeline Undercuts Progress,” counterfeit, falsified, and substandard medicines pose a considerable direct and indirect threat to public health. Substandard medical products increase the likelihood of drug resistance and harm to patients by preventing them from getting the high-quality medical products they need to alleviate suffering and save lives. Falsified medicines usually have no active ingredient or dangerous substances and can cause serious harm to patients. Malaria medicines have been particularly vulnerable to these threats as has been documented recently through a National Institutes of Health (NIH) study documenting the prevalence of substandard or falsified malaria drugs in Africa and Southeast Asia.

PMI is a major procurer of ACTs for public health programs in malaria endemic Africa. In Fiscal Year 2012, PMI procured more than 73 million treatments. As such, we take the issue of ensuring drug quality very seriously and employ rigorous measures to ensure the integrity of the medicines that we supply. We ensure that all medicines directly procured are subjected to stringent quality assurance measures which include pre-shipment, concurrent, or other quality testing.

PMI is responding to this threat by increasing support to prevent the introduction of counterfeit drugs into supply chains, increasing support of national regulatory authorities to improve drug quality through activities such as post market surveillance, technical assistance on quality assurance testing through technology such as mini-labs, and strengthening capacity for regulation in both the public and private sectors.

PMI also employs various screening tools to identify substandard drugs. Last month, PMI entered into partnership with the U.S. Department of Health and Human Services, Food and Drug Administration to test the Counterfeit Detection Device (CD-3), a handheld screening device that can be used to detect falsified medicines at any point in the supply chain. The first pilot will be conducted in Ghana.

Further, we recognize the role of law enforcement, regulation and investigatory actions in addressing issues pertaining to counterfeit/falsified medicines or the theft and diversion of medicines [PDF, 60.6KB].

Despite these challenges, the unprecedented scale-up of malaria prevention and treatment interventions over the past 10 years in sub-Saharan Africa is having a major impact on malaria illnesses and deaths. According to the World Health Organization’s (WHO’s) 2012 World Malaria Report, the estimated number of global malaria deaths has fallen by more than one third- from about 985,000 in 2000 to about 660,000 in 2010. PMI continues to see strong progress [PDF, 1.3MB] – mortality rates among children under 5 years of age in 12 PMI focus countries with two or more nationwide household surveys that measured mortality have shown declines ranging from 16 percent (Malawi) to 50 percent (Rwanda).

Rear Adm. Tim Ziemer
U.S. Global Malaria Coordinator