Written by Yulia Johansen, Health Systems Practice Area Lead
“The ARVs [antiretrovirals] weren’t real. They were actually filled with sawdust and they were yellow. The yellow paint was what you use to paint street lines. This is what they were giving people.”
– Peter Cerka, Crown Agents USA
The market for counterfeit and substandard medicines is booming. In the malaria “market segment”, according to research from the World-Wide Antimalarial Resistance Network (WWARN), almost one-third of the antimalarials tested from 1946 to 2013 failed chemical and/or packaging analysis. In a recent epidemic of fake artesunate in mainland South East Asia, 38-53% of antimalarials obtained from pharmacies were counterfeit.
So quality assurance matters, particularly in the case of major public health challenges, like malaria, against which the global community has directed major investments. The medical impact of poor quality antimalarials includes increased mortality and morbidity, drug resistance and loss of medicine efficacy, and the adverse effects of incorrect active ingredients.
The non-medical impacts are as significant. In addition to endangering lives, poor quality antimalarials drain value from other health systems investments by eroding confidence in health systems, increasing burden for health workers and regulators, and creating economic loss for patients, families, and producers of good-quality medicines.
About 3.2 billion people, almost half the world’s population, are at risk for malaria. Our investments need to match the scale of the challenge. For our part, Crown Agents has been addressing the malaria quality assurance challenge at scale: over the last three years, we’ve inspected 1.4 billion long-lasting insecticide treated bed nets (LLINS) and 8.6 million rapid diagnostic test (RDT) kits across countries in Asia, Africa, Europe, and the Americas.
This global experience has taught us a few important lessons about what an effective quality inspection regime for antimalarials should include:
Pre-shipment Inspection. A physical pre-shipment inspection, verification, and review of documentation confirms the quality of the packaging, labeling, and marking and batch compliance with the requirements of the supply contract. Assuring the quality of product identification and security is a critical part of ensuring that the correct medicines are ultimately administered to patients.
Upstream sampling and laboratory testing. Using independent laboratories to test samples, per the WHO Finished Product Specifications, helps ensure the quality of the medications. Delivery delays can be minimized by performing that sampling immediately following the manufacturer’s release from internal quality control.
Manufacturer assessments. Pre-planned inspection visits to manufacturers’ premises provide visibility into manufacturing processes, quality systems, supply of raw materials and packing, internal control procedures, traceability, and record keeping.
Quality assurance matters- without it, value drains from the global community’s largest public health investments and, more importantly, we endanger the lives of those we seek to benefit. By committing to quality assurance, and including a few established quality assurance protocols in public health programs, together we can bust the booming market for counterfeit and substandard medicines.
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