// November 18, 2014

How Fear of Ebola Is Paving the Way for Poor-Quality Medicines

Fear of Ebola

As Liberia grapples with the national emergency swirling around Ebola, malaria—a disease that is endemic in Liberia—continues to be a major threat to the health of this nation and its people.

In the three African countries hardest hit by the scourge of Ebola—Guinea, Sierra Leone and Liberia—deaths caused by malaria are expected to rise.

Adding a layer of complication to the Ebola crisis is a detectable surge in poor-quality single antimalarials—also known as monotherapies—circulating in Liberia’s open markets.

The Ban on Antimalarial Monotherapies

For decades, affordable and effective medicines to treat malaria were readily available throughout the world. But by the 1960s, malaria parasites started developing resistance to chloroquine, one of the most commonly used antimalarials at the time.

Over decades, rampant drug resistance to single antimalarials created a tremendous burden on efforts to prevent and control the spread of the disease, particularly in parts of Asia and Africa. Eventually, combination treatments such as artemisinin-based combination therapies (ACTs) were found to me more effective than monotherapy drugs in treating malaria as well as preventing further drug resistance.

Today, the World Health Organization has recommended the adoption of ACTs as the treatment of choice in malaria-endemic countries, recognizing that continued use of monotherapy treatments has the potential to lead to catastrophic consequences for global health.

Liberia’s Fight against Fake and Substandard Medicines

With financial support from the U.S. Agency for International Development (USAID) and technical support from the U.S. Pharmacopeial Convention (USP), the Liberia Medicines and Health Products Regulatory Authority (LMHRA) was established in 2010. The LMHRA is responsible for the registration of medicines and drug quality control. A major goal of the LMHRA has been to identify poor-quality medicines in Liberia’s markets and provide the evidence needed for enforcement actions against purveyors of fake and substandard drugs.

What began as an eight-person staff in 2010 has now grown to an agency with 48 employees, conducting regular medicine quality monitoring (MQM) activities throughout Liberia. LMHRA’s work has led to multiple drug recalls and actions by local police authorities to remove poor-quality medicines from circulation. Today, LMHRA’s efforts include expanded quality control laboratory testing, increased registration of medicines for tracking and marketing authorization and improved inspections of medicines entering and circulating in the Liberian market through the use of a mobile database with easy-access to registration records.

While ACTs are the established treatment of choice for combatting malaria, unregistered monotherapies are still being found in Liberia’s private and public markets. The MQM assessments conducted by the LMHRA and PQM of mono- and combined therapies for malaria showed that 70% of the products failed quality tests. It was also observed that a majority of the failed samples were monotherapies, leading the LMHRA to enact a ban on the use of monotherapy drugs as a treatment for malaria.

Dealing with Malaria and Ebola at the Same Time

Despite LMHRA’s ban, surveillance of Liberia’s markets in October has resulted in the confiscation of huge quantities of unregistered amodiaquine monotherapies. Local health authorities, healthcare providers and pharmacists are increasingly concerned about this observed rise in amodiaquine and are warning against the use of this drug among confirmed and suspected Ebola patients, since it not only undercuts the effectiveness of legitimate treatments for malaria but also cheats citizens at a time of maximum vulnerability.

There is no doubt that continued public fears about the spread of Ebola are contributing to the use of whatever medicines are available—even those that may have no impact whatsoever on Ebola. As the demand for medicines grows, the spike in amodiaquine in Liberia’s markets indicates that sellers of poor-quality products are taking advantage of the Ebola crisis and flooding markets with fake and substandard medicines—at a great cost to the public.

Also troubling is that among the potential side effects of amodiaquine is weakness, dizziness, nausea and anorexia—symptoms similar to those of Ebola. Thus, increased intake of amodiaquine could mask—and even worsen—some conditions associated with confirmed and suspected Ebola cases.

LMHRA’s ability to register and monitor medicines in Liberia plays a valuable role in helping the nation through this time of crisis. But surveillance efforts alone will not be enough. Public awareness about the dangers of amodiaquine monotherapy and its potential threats when dealing with confirmed and suspected cases of Ebola will need to be augmented.

The work of LMHRA is supported by the Promoting the Quality of Medicines (PQM) program, a collaborative effort between USAID and USP. With additional assistance from the President’s Malaria Initiative, the World Health Organization and other similar groups, Liberia’s ability to monitor medicine quality and protect its people from unlawful sellers and importers of substandard and counterfeit medicines will continue to strengthen.

To learn more about PQM’s activities in Africa and throughout the world, visit USP’s website.

Latifa El-Hadri, Ph.D., is a senior program manager focused on the Africa region for the Promoting the Quality of Medicines Program.