The number of people receiving treatment for cancer has risen dramatically in the last decade in many African countries. For example, 10 years ago in Ethiopia and Kenya, cancer care was available to only a few thousand patients per year in a few hospitals. Today, over 75,000 people receive cancer treatment each year in each of these countries.
Over 800,000 people on the continent are diagnosed with this disease each year.
But medicine regulatory agencies in many countries don’t have the capacity to measure the quality of anticancer drugs. This is particularly problematic for two reasons. Firstly, the high cost of the drugs is an incentive to opt for unverified ones. And secondly, they are highly toxic.
The combination of high demand but low capacity for regulatory oversight in a market renders it vulnerable to substandard and falsified medical products. There have been disturbing reports of substandard or falsified products causing harm to patients in a number of countries, including Brazil, the US and Kenya. But no systematic studies of anticancer drug quality across low and middle income countries have been done. As a result little is known about the quality of the drugs being used to treat cancer in Africa.
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I am a cancer researcher in the US and I develop technologies for finding substandard or fake medicines in low-resource settings. In 2017, I teamed up with Ayenew Ashenef at Addis Ababa University to test a device designed to evaluate quality of cancer medicines. We were dismayed to find that most of the drug in use at a hospital in Ethiopia was substandard. We then extended the study.
Our recent study investigated the quality of seven anticancer drugs in four African countries. The drugs were cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin. Most of these drugs are given to patients intravenously. They are used to treat breast cancer, cervical cancer, cancers of the head and neck, cancers of the digestive system, and many other types. Some are also used to treat autoimmune diseases such as lupus.
Members of our research team collected 251 anticancer products in Cameroon, Ethiopia, Kenya and Malawi in 2023 and 2024. Products were collected both covertly and overtly from 12 hospitals and 25 private or community pharmacies, covering both public and private healthcare systems in each country.
We assessed the assay value – the quantity of the active pharmaceutical ingredient in each dose – of the samples we had collected.
We found substandard or falsified anticancer medicines in all four countries. We discovered that 32 (17%) of 191 unique lots of seven anticancer products did not contain the correct amount of active pharmaceutical ingredient. Substandard or falsified products were present in major cancer hospitals and in the private market in all four countries.
Based on our findings it’s clear that oncology practitioners and health systems in sub-Saharan Africa need to be aware of the possible presence of substandard anticancer products. We also recommend that regulatory systems be strengthened to provide better surveillance.
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The research
To measure the amount of active pharmaceutical ingredient present in a vial or tablet, we used high-performance liquid chromatography, or HPLC. This separates and quantifies molecules and is the “gold standard” method for testing the amount of active pharmaceutical ingredients in tablets, capsules and vials of medicine.
Before we prepared the medicines for analysis, we inspected the medicines and their packaging materials. Then we used the HPLC to measure the amount of active pharmaceutical ingredient present to see if it matched the claim on the label. Every pharmaceutical product has a target assay range that is defined in its pharmacopeial monograph. This is usually 90%-110% of the amount of active pharmaceutical ingredient claimed on the package. So, for example, if a vial claims to contain 100 milligrams of doxorubicin, it is still counted as “good quality” if it has 93 milligrams of doxorubicin, but not if it contains 38mg or 127mg.
Out of the 191 unique batch numbers, 32 failed assay – about one in six.
There were several manufacturers whose products failed assay at higher rates. There were no significant differences in failure rate for products collected in different countries, in hospitals versus pharmacies, or even for products that were tested after their expiration date vs before their expiration date.
Most countries in Africa use visual inspection to identify suspect anticancer medicines. Products can fail visual inspection if they are the wrong colour when reconstituted or contain visible particles, or if there are irregularities related to the packaging. One surprising result from our study was that products that failed high-performance liquid chromatography could not be distinguished visually from products that passed the test. Only three of the 32 failed products showed any visible irregularities.
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Read more: Africa imports over 70% of its medicines. Making active ingredients locally would change this
Moving forward
The situation we uncovered is likely to be similar in other low income countries. Our hope is that the global research community can focus more attention on the quality of this class of medicines through increased research. This was done for antimalarials in the 2000s, and resulted in a turnaround in quality for those drugs.
We have shared our findings with regulators in the four countries where the samples were collected, and are working to build capacity for post market surveillance of these critical medicines.
Information about the quality of anticancer medicines is critical because cancer chemotherapy is a careful balance between killing the cancer and killing the patient. If the patient’s dose is too large, they can be harmed by toxic side effects of the drug. If the patient’s dose is too small, the cancer may continue to grow or spread to other locations, and the patient may lose their precious window for treatment.
Marya Lieberman, Nancy Dee Professor, Department of Chemistry and Biochemistry, University of Notre Dame
