Patients at risk: 1 in 6 cancer drugs in Kenya found substandard
A medic displays cancer drugs.
What you need to know:
- The medications included in the study which are commonly found in the country are cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin.
One in six cancer medications in Kenya contains defective formulations that could kill patients or allow cancer cells to spread unchecked, a new study has revealed.
The research found that cancer drugs across Kenya and three other countries have dangerous potency levels, either too low to fight cancer effectively or so high such that they poison patients with toxic side effects.
The study, published in The Lancet, uncovered a concerning prevalence of substandard anticancer medications in major hospitals and private pharmacies in Kenya.
The study, which was done in Kenya, Ethiopia, Malawi and Cameroon revealed that between 14 per cent and 24 per cent of the drugs failed quality tests, meaning that patients might not be receiving the correct dosage for their treatment.
Nearly a quarter of the products (59 out of 251) had expired before analysis, some by almost a year, their presence highlighting issues in inventory management and supply chain integrity.
Conducted by Notre Dame University between April 2023 and February 2024, the study showed that the purity or potency of an active pharmaceutical ingredient (API) in a drug should be between 90 per cent to 110 per cent. However, tested medication had APIs ranging from 28 per cent to 120 per cent.
“Anticancer products must meet compendial requirements for licensing or regulatory approval,” the study says.
The medications included in the study which are commonly found in the country are cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin.
They are used for various purposes, including slowing the growth of cancer cells, destroying the DNA of cancer cells, interfering with their ability to replicate, and ultimately leading to cell death. Other drugs are used as an antidote to the harmful effects of other cancer medicines given in high doses.
Correct dose
These drugs are used to treat various forms of cancer, including cancers of the bladder, ovaries, testicles, colon, breast, bladder, lung, stomach, and ovarian cancers, as well as lymphomas, leukemia, certain paediatric cancers- nerves, eyes, bone marrow and the skin.
“The assay value (the quantity of the active pharmaceutical ingredient provided in the dosage form compared with the quantity stated on the packaging materials) is of particular importance for ensuring that patients receive the correct dose,” says the study
It adds: “Regulatory agencies in lower and middle income countries often do not have the necessary reference materials for conducting chemical assays of anticancer drugs and might not have the personal protective equipment and chemical fume hoods or laminar flow cabinets needed to handle anticancer drugs safely.”
The study highlights several contributing factors to this alarming situation. The exponential growth in cancer treatment demand in sub-Saharan Africa, coupled with constrained budgets, pressures Health ministries to procure the lowest-cost products.
“The confirmed presence of substandard anticancer medicines has dire consequences for patient outcomes. Correct dosing of these highly potent drugs is critical for effective treatment and minimising severe side effects. When patients receive inadequate or incorrect doses, their treatment can fail, leading to disease progression, increased suffering, and potentially fatal outcomes,”
Dr Stella Kivila, director, Healthtech Strategy & Impact, Salient Advisory, explains that the presence of substandard cancer medications in countries like Kenya is a deeply concerning issue, with significant implications for patient outcomes and trust in healthcare systems.
She noted that the problem is not entirely surprising given the systemic challenges in regulatory frameworks across Africa. Several factors contribute to the prevalence of substandard medications, including under-resourced regulatory systems, lack of quality checks, environmental conditions, complex supply chains, high demand and affordability issues and porous borders and corruption.
“Many regulatory bodies in Africa lack sufficient funding, real-time surveillance tools, and laboratory capacity to effectively test and verify the quality of medicines. This creates loopholes that allow substandard products to enter the market. There's also an insufficient number of checks for the quantity and quality of active pharmaceutical ingredients at various points in the supply chain. This means even if a medicine is manufactured correctly, its integrity can be compromised during transit.
“Medicines can degrade due to improper storage conditions such as exposure to high temperatures and humidity, which are common in many African regions without climate-controlled storage. This turns what might have been a good product at the point of manufacture into a substandard one by the time it reaches the patient,” said Dr Kivila.
She added that long and intricate supply chains with multiple intermediaries increase the risk of product tampering and substitution. “The high demand for cancer medications, coupled with affordability challenges, can drive patients to less-regulated marketplaces where the risk of encountering substandard drugs is higher. Some manufacturers may also exploit weaker regulatory environments to cut corners. Porous borders and corruption can also allow illegal and falsified drugs to enter healthcare systems.”
The consequences of substandard cancer medication are dire and range from compromised treatment outcomes to toxicity and adverse effects. If a medication contains too little of the active ingredient (under-dosing), the cancer may not be effectively treated, leading to disease progression, spread, and treatment failure. Patients may not achieve the expected clinical outcome, and their condition could worsen.
Conversely, if a medication contains too much of the active ingredient, it can become toxic, leading to severe side effects, organ damage, and even death. The drug can essentially act as a poison to the patient.
“This can also lead to loss of patient trust. When patients receive ineffective or harmful medications, it erodes their trust in the healthcare system, healthcare providers, and the medicines themselves. This can lead to patients giving up on treatment,” said Dr Kivila, adding: “It also has an economic burden. Patients and health systems waste valuable resources on ineffective treatments. Families may deplete their savings on medications that do not work. For certain medications, under-dosing can contribute to the development of drug resistance, making future treatments even more challenging.”
She highlighted that combating substandard medication in Africa demands a comprehensive strategy and African innovations. Some already exist, such as RxScanner in Nigeria, used to instantly verify drug composition at the point of care, and FIGORR, a low-cost sensor device that monitors environmental conditions such as temperature, location, movement and humidity throughout the supply chain. These innovations provide real-time alerts, helping to identify compromised medication and ensure product integrity from manufacturing to patient.
The study itself suggests that governments and international partners invest in building the capacity of regulatory agencies to conduct thorough quality surveillance, including chemical assays for anticancer drugs, and for healthcare providers and patients to be vigilant about the potential for substandard products and advocate for improved quality control.
The study also calls for additional research to determine the market share and prevalence of substandard anticancer products, and to assess their actual impact on patient care outcomes.
