Madrid, 26 (Servimedia)
Approximately one in six oncological medications from sub -Saharan Africa has serious quality defects.
This follows from a new research at the University of Notre Dame (France) published Thursday in the magazine ‘The Lancet Global Health’.
The researchers gathered different medications against Cameroon, Ethiopia, Kenya and Malaui, and evaluated whether each one complied with the regulatory standards. The authors considered various factors, such as appearance, packaging, labeling and, above all, the analytical value.
The test value is the amount of active pharmaceutical ingredient (IFA) present in each medication. To meet safety standards, most products must contain between 90% and 110% of IFA’s correct amount.
The researchers measured the IFA content of each product and compared that figure with the one indicated in the drug container.
“It is important that cancer medications contain the adequate amount of active ingredients for the patient to receive the correct dose,” says Marya Lieberman, chemistry and biochemistry professor at the university of Notre Dame.
Lieberman adds: “If the patient’s dose is too low, cancer can survive and spread to other areas. If the patient’s dose is too high, he can suffer toxic side effects of the medication.”
It was discovered that one in six analyzed cancer medications contained an incorrect amount of API, with concentrations of between 28% and 120%. The study evaluated 251 samples of cancer medicines collected in hospitals and private markets in the four countries analyzed.
Uncomposed quality
This study is one of the first to evaluate the quality of cancer medications in sub -Saharan Africa. Currently, that region does not have pharmaceutical regulatory laboratories that perform chemical analysis of cancer medicines according to the standards required for regulatory purposes. However, the need for oncological medicines is growing.
“We find poor quality cancer medications in all countries, in all hospital pharmacies and in private markets,” Lieberman sentence, before adding: “We discover that visual inspection, which is currently the main method to detect poor quality oncological medications in sub -Saharan Africa, only detected one in 10 defective products.”
In their study, the researchers explained how the combination of a high demand for cancer medicines, the lack of regulatory capacity and the deficient practices of manufacturing, distribution and storage probably create a problematic environment throughout sub -Saharan Africa.
They also argue that, given these factors and the global supply chain of pharmaceutical products, there are also low quality cancer medications in other low and medium income countries.
The study points out that there are many medications whose quality is not guaranteed by regulatory agencies and some manufacturers take advantage of it to cut expenses.
“There are also problems with distribution systems, so, even if a product is of good quality when leaving the manufacturer, it can be degraded during shipping or storage. These products reach low and medium income countries and are used in patients,” Lieberman Apostille.
Proposals
Researchers propose measures to address this problem, such as offering economic technologies at the point of care to detect poor quality cancer and create policies on how to respond to products that do not exceed detection tests.
Help the regulatory agencies of low and medium income countries to obtain security and training equipment so that they can analyze the quality of cancer medications in their markets, conduct research when the products do not pass the tests, rapid regulatory actions enabled by laboratory data and share data on poor quality products are other proposals.
In addition, the authors propose to perform cost-benefit analysis for interventions that address common problems (such as exhausted medications, insecure shipping, storage or dispensation and lack of availability or affordability of medicines) in order to help those responsible for policies and finances and to obtain the greatest impact on the results of patients with available resources.
Finally, they propose to work with care suppliers to develop specific response policies and messages for patients and involve regulators, donors and other resources.
(Servimedia) 26-Jun-2025 00:30 (GMT +2) MGR/CLC
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