One in six cancer drugs fails to meet safety standards in sub-Saharan Africa

One in six cancer drugs fails to meet safety standards in sub-Saharan Africa

Serious quality defects have been found in a significant number of cancer drugs from sub-Saharan Africa, according to new research from the University of Notre Dame.

For the study published inThe Lancet Global Health,Researchers collected various cancer drugs from Cameroon, Ethiopia, Kenya and Malawi and assessed whether each drug met regulatory standards. Researchers looked at a variety of factors, including appearance, packaging, labeling and, most importantly, test value.

The test value is the amount of the active pharmaceutical ingredient (API) in each drug. To meet security standards, most products should be within 90 to 110 percent of the correct API amount. The researchers measured the API content of each product and compared that number to what was determined on the drug packaging.

It is important that cancer medicines contain the right amount of active ingredients so that the patient receives the correct dose. If the patient's dose is too small, the cancer can survive and spread to other places. If the patient's dose is too high, they may be harmed by toxic side effects of the medicine. “

Marya Lieberman, a professor of chemistry and biochemistry at Notre Dame and senior author of the study

One in six cancer drugs tested was found to contain the wrong amount of API, with drugs tested ranging from 28 to 120 percent of APIs. The study examined 251 samples of cancer drugs collected from major hospitals and private markets in all four countries.

The study, funded by the National Cancer Institute of the National Institutes of Health, is among the first to assess the quality of cancer drugs in sub-Saharan Africa. Currently, sub-Saharan Africa has no pharmaceutical regulatory laboratories that perform chemical analyzes for cancer drugs to the standards required for regulatory purposes.

However, the need for cancer drugs is growing.

“We found bad cancer drugs in every country, in every 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 now the main method for detecting cancer drugs in sub-Saharan Africa, only found one in 10 of the bad products today.”

In their study, researchers explained how a combination of high demand for cancer drugs, lack of regulatory capacity and poor manufacturing, distribution and storage have likely created a problematic environment in sub-Saharan Africa. They also argue that given these factors and the global pharmaceutical supply chain, substandard cancer drugs also exist in other low- and middle-income countries.

Lieberman and her team identified several strategies that could help the global community address poor quality cancer drugs:

• Bereitstellung kostengünstiger Technologien zum Zeitpunkt der Versorgung, um Krebsmedikamente schlechter Qualität zu untersuchen und Richtlinien für die Reaktion auf Produkte zu erstellen, die Screening-Tests fehlschlagen.
• Helfen Sie den Aufsichtsbehörden in Ländern mit niedrigem und mittlerem Einkommen erhalten Sicherheitsausrüstung und Schulungen, damit sie die Qualität von Krebsmedikamenten in ihren Märkten analysieren können, Untersuchungen für Wurzeln durchführen, wenn Produkte nicht getestet werden, schnelle regulatorische Maßnahmen durch Labordaten ermöglicht und Daten zu Produkten aus schlechtem Qualität ausgetauscht werden.
• Führen Sie Kosten-Nutzen-Analysen von Interventionen durch, die häufig auftretende Probleme (z. B. Medikamente, die nicht sicher sind, Versand, Lagerung oder Abgabepraktiken und mangelnde Verfügbarkeit oder Erschwinglichkeit von Medikamenten), um politischen Entscheidungsträgern und Spendengründen die größten Auswirkungen auf die Patientenergebnisse aus ihren verfügbaren Ressourcen zu erzielen.
• Arbeiten Sie mit Pflegehörnern zusammen, um ortsspezifische Reaktionsrichtlinien und Messaging für Patienten zu entwickeln und Regulierungsbehörden, Spender und andere Ressourcen einzubeziehen.

Lieberman and her lab are developing an easy-to-use technology called Chemopad for cancer drug screening. This low-cost paper device could potentially help hospitals, pharmacies and healthcare professionals in low- and middle-income countries monitor drug quality without restricting a patient's access to the medication.

“This is all part of a larger project aimed at developing the chemopad as a point-of-care testing device that we can use.

"There are many drugs where regulators do not have enough resources to verify quality, and some manufacturers use this to cut corners. There are also problems with distribution systems. Even if a product is of good quality, when it leaves the manufacturer, this can degrade during shipping or storage. These products go to low and middle incomes. They are changed to patients. I want to change to patients."

In addition to Lieberman, co-authors are Maximilian J. Wilfinger, Jack Doohan and Ekezie Okorigwe of Notre Dame; Ayenew Ashenef and Atalay Mulu Fentie from Addis Ababa University; Ibrahim Chikowe from Kamuzu Health Sciences; Hanna S. Kumwenda of the Malawi Project at the University of North Carolina; Paul Ndom from the University of Yaounde; Yauba Saidu of the Clinton Health Access Initiative; Jesse Opakas of MOI Teaching and Referral Hospital; Phelix Makoto was from Ampath – Moi Teaching and Referral Hospital; and Sachiko Ozawa and Benyam Muluneh from the University of North Carolina.

This study was funded by the National Cancer Institute under the National Institutes of Health.

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