· Patients suffering needless harm
According to a recent study carried out by researchers in the University of Notre Dame, USA, the use of substandard drugs can be the difference between life and death. It reveals that nearly one in six chemotherapy drugs tested in parts of sub-Saharan Africa was found to be either dangerously under dosed or overdosed. This is the finding from a new research co-authored by Nigerian postgraduate student Ekezie Okorigwe. PharmaTimes Editor, MORGAN NWANGUMA writes that the researchers emphasise the fact that serious quality defects were found in a significant number of cancer medications from sub-Saharan Africa, stressing that poor-quality medicine in Africa is often driven by weak regulatory systems.
Going by the outcome of this latest study, the clear implication is that even in Nigeria, practically one out of every six chemotherapy (treatment) carried out is either precariously below normal dose or above the required dosage thereby posing serious risks to patients. Experts say in addition, the need for cancer drugs continues to grow.
The large-scale study, published in The Lancet Global Health, examined 251 samples of seven widely used cancer drugs. These samples were collected from hospitals, pharmacies, and informal suppliers in Ethiopia, Kenya, Malawi, and Cameroon between April 2023 and February 2024. Results showed that 19% failed to meet international quality standards—some containing as little as 28% of the active ingredient, while others exceeded 120%.
Safety Standards
The assay value is the quantity of active pharmaceutical ingredient (API) present in every medicine. In measuring up to safety standards, the majority of products should be within a range of 90 to 110 per cent of the right amount of API. Scientists measured the API content of every product and compared that number to what was designated on the drug packaging. “It is important that cancer medications contain the right amount of the active ingredients so the patient gets the correct dose,” said Marya Lieberman, professor of chemistry and biochemistry at Notre Dame and lead author of the study. “If the patient’s dose is too small, the cancer can survive and spread to other locations. If the patient’s dose is too high, they can be harmed by toxic side effects from the medicine.”
Okorigwe, who collaborated with a multinational team of scientists, said his drive to confront the issue stems from a deep personal belief in the importance of trust.
“When people buy medicine, they should be able to trust that it will do what it’s supposed to do,” he told the PUNCH recently. “Bad quality drugs can harm the body in ways that cannot always be reversed, even if treatment is later corrected.”
He noted that substandard cancer medicines not only squander the resources and research that go into their production but also cause needless suffering for patients. “It’s painful for people to spend money on treatment, hoping to get better, only for the drug to make things worse,” he said.
The research project, financed by the (American) National Cancer Institute of the National Institutes of Health, is one of the first to assess the quality of cancer drugs in sub-Saharan Africa. At present, sub-Saharan Africa has no pharmaceutical regulatory laboratories carrying out chemical analyses for cancer drugs in line with the standards needed for the purposes of regulation.
To tackle the issue, Okorigwe and his colleagues are creating an affordable, portable testing tool called the chemoPAD—a paper-based card designed to rapidly check the quality of chemotherapy drugs. Project leader and analytical chemist Professor Marya Lieberman, who also serves as Okorigwe’s advisor, compared the device to the batik cloth-printing technique—only this time, applied to medicines.
“The card has wax-printed lines forming channels. We smear a small amount of the drug between two arrows; dip the card in water, and the water carries the chemicals through the channels to meet the drug. If the medicine is of poor quality, it produces specific colours,” she explained.
Although the chemoPAD cannot fully replace advanced laboratory testing, it can flag the “worst of the worst”—medicines containing less than half of their required active ingredient—at a fraction of the cost. Traditional lab analysis can cost up to $1,200 per sample and require around 100 tablets, while the chemoPAD can deliver results using just one pill.
“We found bad-quality cancer medications in all of the countries, in all of the hospital pharmacies and in the private markets,” said Lieberman, an affiliate of Notre Dame’s Eck Institute for Global Health and Harper Cancer Research Institute. “We learned that visual inspection, which is the main method for detecting bad-quality cancer drugs in sub-Saharan Africa today, only found one in 10 of the bad products.”
Originally developed to test antibiotics and tuberculosis drugs, the technology is already capable of analysing 10 medicines on the World Health Organization’s priority watch list. With further funding, researchers aim to expand its reach to cover additional antibiotics and antimalarials, which are also highly vulnerable to quality problems in low- and middle-income countries.
Weak Systems
Professor Lieberman emphasised that poor-quality medicines in Africa are often driven by weak regulatory systems, the pressure to source cheaper drugs, and the complexity of supply chains.
“Substandard cancer drugs can mean the difference between life and death,” she warned.
Cancer cases in sub-Saharan Africa have doubled over the past three decades, and experts caution that substandard medicines could further erode already low survival rates. For Okorigwe, the way forward is to embed routine quality surveillance into everyday healthcare.
“Clinicians are not trained to carry out complex lab tests in the field,” he said. “We need simple, portable, and effective tools to protect patients, and that’s what this research is about.”
In their research, the scientists explained how a combination of high demand for cancer medications, absence of regulatory ability, and poor manufacturing, distribution and storage practices possibly brought about a difficult environment all through sub-Saharan Africa. Also, they argue that given these factors and the worldwide supply chain for pharmaceuticals, inferior cancer drugs may be present in other low and middle-income countries too.
New Strategies
Lieberman and her team found numerous approaches that could aid the global community tackle poor-quality cancer medications:
· Offer cheap technologies at the point of care to screen for bad-quality cancer medicines and create policies for how to respond to products that fail screening tests.
· Aid regulatory agencies in low and middle-income countries get safety equipment and training so they can analyze the quality of cancer medicines in their markets, conduct root-cause investigations when products fail testing, take quick regulatory actions enabled by lab data and share data about bad-quality products.
· Carry out cost-benefit analyses of interventions that tackle common problems (such as medications being out of stock, unsafe shipping, storage or dispensing practices, and lack of availability or affordability of medications) to help policymakers and funders get the most impact on patient outcomes from their available resources.
· Synergize with care providers to develop site-specific response policies and messaging for patients and engage regulators, donors and other resources.
The chemoPAD cancer drug screening device will monitor drug quality without restricting a patient’s access to the 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,” Lieberman said.
“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,” she added.
In addition to Lieberman, co-authoring with Ekezie Okorigwe include Jack Doohan also from Notre Dame; Maximilian J. Wilfinger; Ayenew Ashenef and Atalay Mulu Fentie from Addis Ababa University; Ibrahim Chikowe from Kamuzu University of Health Sciences; Hanna S. Kumwenda from the University of North Carolina Project Malawi; Paul Ndom from University of Yaoundé; Yauba Saidu from the Clinton Health Access Initiative; Jesse Opakas from the Moi Teaching and Referral Hospital; Phelix Makoto Were from AMPATH – Moi Teaching and Referral Hospital; and Sachiko Ozawa and Benyam Muluneh from the University of North Carolina.
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