Risk-Based Approach to Quality Control Generates Malaria Cost Savings without Sacrificing Patient Safety

When a mother takes her daughter to the health clinic because of a fever and learns she needs to treat her for malaria, she trusts that the medicine the nurse gives her is safe and effective. For the nearly 228 million malaria cases in 2018, healthcare workers implicitly relied on quality assurance checks throughout the supply chain to ensure the medicines that patients took ensured health without inflicting an unnecessary burden of risk. Without this security, patients may learn to distrust health programs, causing losses where we have seen such great gains in improving health worldwide.

Quality assurance is fundamental in the pharmaceutical industry. Without it, companies cannot guarantee that their products comply with the appropriate standards for quality and safety, and patients cannot trust that products are safe to consume. For the U.S. President’s Malaria Initiative (PMI), patient safety is no different.

Dora Amoah, a 72-year-old retired teacher, mother of five and grandmother who lives in the Eastern region of Ghana spoke of the many reasons why she trusts her health center, “I can be assured of quality care, quality medications, non-expired drugs [when I go there]. Besides why go to a place where they will not be able to manage complications and side-effects? This will only delay my care and treatment and if there are any serious complications, it might be too late.”

Ensuring the trust of patients like Dora is why quality assurance and control of health commodities is an integral component in the supply chain process. PMI, through the USAID Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) project, has procured malaria commodities for countries around the world valued at US$530 million. These include $107 million of artemisinin-based combination therapies (ACTs), the first line medication for treating uncomplicated malaria in most countries. Historically, every single batch of generic ACTs purchased on behalf of PMI by GHSC-PSM has undergone quality assurance (QA) by batch testing exclusively by third-party laboratories. These tests ensure proper therapeutic concentrations, as well as consistent and predictable performance of the medications.

Increasingly, however, new medicinal agents are being produced and more sophisticated analytical methods are being developed to evaluate them. In private sector pharmaceutical production, risk-based quality testing is one approach to quality control that has emerged as an alternative to batch testing thanks to these innovations. Rather than testing every batch, risk-based quality control involves testing a few batches at random to monitor and assure the quality of the products.