When a thousand children and adults in a rural province in the Democratic Republic of the Congo were stricken by a painful muscle disorder in 2015, doctors thought it was a meningitis outbreak.
Instead, the villagers were victims of a cruel problem that mainly afflicts the poor: counterfeit drugs. According to a study in Lancet Global Health, the Congolese had unwittingly taken an anti-psychotic drug falsely labeled as diazepam or Valium. Eleven died, five of them children.
Counterfeit and substandard drugs remain a global problem, especially in developing countries where powerful, mislabeled drugs may be purchased in illegal street markets or even unwittingly dispensed by clinics, hospitals and pharmacies.
The World Health Organization says anti-malarials and antibiotics are among the most commonly faked drugs. “Every incident is different … but basically it’s all about the money,” the organization’s Pernette Bourdillon-Esteve told a workshop last year.
It is a scourge within the scourge of malaria, a treatable disease that still kills more than 420,000 each year, mainly children in sub-Saharan Africa.
In the Congo case, Médecins Sans Frontières doctors became convinced the mislabeling of the anti-psychotic drug haloperidol was deliberate. After a regional World Health Organization alert, a medicine supplier in Kampala, Uganda, was found to be shipping fake diazepam pills.
With a global supply chain, countries need strong regulators and well-equipped labs to police drug manufacturing and distribution and protect the public from harm.
The U.S. Pharmacopeial Convention, a nonprofit organization that sets standards for drug quality and purity, is helping nearly three dozen countries on four continents bolster their national laboratories to safeguard their medicine supply lines. The U.S. Agency for International Development underwrites the convention’s global initiative, called “Promoting the Quality of Medicines.”
“Most of what we do is about human capital development,” says Patrick Lukulay, who focuses on Africa initiatives for the U.S. Pharmacopeial Convention.
The organization tutors local drug makers on good manufacturing practices and uses its state-of-the-art labs in Ghana, Brazil, India and China to test drug samples and share expertise. “We’ve trained 250 regulators from 40 countries in Africa in three years,” says Lukulay.
Detecting tomorrow’s problems
Some counterfeits are sophisticated enough to fool pharmacists, but not chemical analysis. Nowadays field inspectors use inexpensive test kits that fit into a suitcase to detect fakes.
The U.S. Pharmacopeial Convention began setting benchmarks for drug strength and purity in 1820. Today, its standards — which also address labeling, packing and proper storage — are recognized in 140 countries.
“In the United States we take for granted what’s in the bottle is what’s supposed to be in the bottle,” says Kate Bond, vice president for international regulatory affairs. But roughly 10 percent of the 1,100-member convention staff work overseas in recognition of what she calls “the globalization of the supply chain.” (The World Health Organization and several countries and regions have pharmacopoeias of their own, which all work to harmonize standards.)
As more and more counterfeit drugs are sold on the internet and shipped across borders, “Everyone’s affected by this,” Bourdillon-Esteve told a conference in Sweden. “Both very expensive and very cheap medicines have been falsified.”