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

Related Supply Chain Topics
Lead Paragraph/Summary

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.

Dora Amoah in Ghana prefers getting medicine for herself and her family from the health center rather than the drug stores. Photo credit: Gloria Agyekum, GHSC-PSM
Dora Amoah in Ghana prefers getting medicine for herself and her family from the health center rather than the drug stores. Photo credit: Gloria Agyekum, GHSC-PSM
Dora Amoah in Ghana prefers getting medicine for herself and her family from the health center rather than the drug stores. Photo credit: Gloria Agyekum, GHSC-PSM
Body Text

In keeping with PMI’s goals of applying international standards, using data for decision-making, and incorporating proven approaches from the private sector to public health programs, in August 2018, GHSC-PSM drew on industry best practices to establish a risk-based approach that would reduce third-party QC testing of the most commonly procured ACTs.

To transition to a risk-based QC model, the project first collaborated with manufacturers through cross-functional teams to perform a statistical trending analysis of ACT QC testing data. Using a scientific, risk-based model that relies on international pharmaceutical standards (ICH Q8-Q12), GHSC-PSM identified and defined potential critical quality attributes (CQA) of ACTs such as the active ingredient content or dissolution properties. The project then used the Failure Modes and Effects Analysis (FMEA) tool to rank the risks, and made a recommendation to PMI on the frequency and methodology for QC testing based on the results of the analysis.

In the first year after implementation, QC testing based on risk identification confirmed quality standards of ACTs, but also decreased the cost associated with testing these medicines. From August 2018 to December 2019, savings on quality testing reached $364,336, cost-savings that will allow PMI to redirect funds to activities such as procuring additional treatments. The activities and approaches used to achieve reduced QC testing can be used as a roadmap for additional products and by other donors in implementing best practices for quality testing strategies.