About one in six tested chemotherapies in sub-Saharan Africa were found to have serious quality defects, according to the results of a study published in The Lancet Global Health.
Researchers assessed the appearance, packaging, and labeling of each cancer medication and measured the quantity of active pharmaceutical ingredient found in each product and compared it with the expected number for each medication to determine if the product met regulatory standards or not.
“We found bad-quality cancer medications in all of the countries, in all of the hospital pharmacies and in the private markets,” said lead study author Marya Lieberman, PhD, Professor of Chemistry and Biochemistry at University of Notre Dame. “We learned that visual inspection, which is the main method for detecting bad-quality cancer drugs in sub-Saharan Africa today, only found 1 in 10 of the bad products.”
“Oncology practitioners and health systems in sub-Saharan Africa need to be aware of the possible presence of substandard anticancer products when designing care protocols and evaluating patient outcomes, and regulatory system strengthening is needed to provide better surveillance of this crucial class of medicines,” the study authors stressed in their published report.
Study Methods and Rationale
Quality surveillance for cancer medications is lacking in low-income and middle-income countries, as many health-care regulatory agencies in these countries do not have the capacity or resources to assess all incoming oncology drugs, especially as demand increases. This creates conditions in which falsified or low-quality medical products can more easily enter the supply chain.
This was one of the first studies to evaluate cancer drug quality in sub-Saharan Africa.
“There are lots of medicines where the regulators don’t have enough resources to verify the quality, and some manufacturers take advantage of that to cut corners. There are also problems with distribution systems, so even if a product is good quality when it leaves the manufacturer, it may be degraded during shipping or storage. These products flow into low- and middle-income countries, and they get used on patients. I want to change that,” said Dr. Lieberman, who is also an affiliate of Notre Dame’s Eck Institute for Global Health and Harper Cancer Research Institute.
To conduct their quality assessment, researchers collected samples of seven chemotherapies between April 6, 2023, and February 12, 2024, from 12 hospitals and 25 private or community pharmacies in Ethiopia, Kenya, Malawi, and Cameroon. The seven chemotherapies studied were cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin. Investigators intended to collect 10 different brands and lot numbers of each active pharmaceutical ingredient.
Assessment included visual inspection and testing of the percentage of active pharmaceutical ingredient with high-performance liquid chromatography assays.
Key Study Findings
Researchers collected a total of 251 samples, including 191 unique brands and lot numbers. Four percent of the unique lot numbers failed visual inspection. The sensitivity of visual inspection for detection of failing products was 9% and the specificity was 97%.
The quantity of active pharmaceutical ingredient in the tested chemotherapies ranged from 28% to 120% of stated contents. Regulatory standards call for a range of 90% to 110%.
Failure rates ranged from 14% to 24% across all included countries, hospitals, and pharmacies. Twenty-four percent of the products had expired prior to assessment—some by close to a year. Expired products did not fail the assay more often than nonexpired products (17% vs 20%).
Going Forward
The study authors also identified strategies that could help the global community address possible low-quality cancer medications. They suggested providing inexpensive technologies at the point of care to screen for low-quality drugs and creating policies around responses to failed products. They suggested that regulatory agencies in these low- and middle-income countries need help getting access to safety equipment and training for analysis of medication quality. Cost-benefit analyses of interventions for common problems leading to poor-quality cancer medications entering the market could help policymakers and funders make a significant impact.
The study authors are also developing a low-cost, user-friendly technology called chemoPAD for screening quality of cancer medications without restricting access to medication.
“This is all part of a bigger project aimed at developing the ChemoPAD as a point-of-care testing device that we can use, something that’s more accurate in detecting poor-quality products than just visual inspection,” Dr. Lieberman said.
Disclosure: This study was funded by the National Cancer Institute of the National Institutes of Health. For full disclosures of the study authors, visit thelancet.com.
