Counterfeit Medication Threat: The need to focus on drug quality control

The issue of substandard and counterfeit medicines is on the rise and is threatening the very foundation of public Health in many African countries. Eminent persons like the former French President Jacques Chirac and former U.S president Bill Clinton have been on the front line to fight the scourge.

Link to article on Counterfeit anti malaria medicines http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3375661/

Different African Governments have adopted multiple strategies to prevent the counterfeit medicines from reaching the citizens but these efforts are often compromised by corruption, ignorance and poverty.

In Cameroon, for example, there is a stringent procedure in place to get a drug marketed in the country and a supply chain surveillance that ensures that genuine products reach officially recognized outlets.  Unfortunately, apart from the officially recognized outlets, there is a parallel illegal market for medicines that is making, maybe the same turnover as official outlets but mostly in products of doubtful origin and composition.

Seized illicit pharmaceuticals in Douala (2008).

In the light of these drug quality challenges, it is salutary to know that the Presbyterian Church in Cameroon (PCC) and the Cameroon Baptist Convention have set up quality control laboratories  to make simple qualitative and quantitative tests for many essential medicines used in their respective hospitals and the country at large.

The laboratories were set up with the help of the Germany based Institute for Medical Mission (Difaem). The Institute continues to support the labs by supplying reagents and carrying out more sophisticated and confirmatory tests on behalf of her Cameroon partners. Similar Difaem funded labs are found in Ghana, Nigeria, Malawi, Kenya and India.

During my visit to the PCC quality control lab in Limbe, I decided to participate in the quality control test of a sample of Co-trimoxazole (an antibacterial drug). Guided by the pharmacist of the PCC Nyaah Fidelis Ngoh, we carried out qualitative and quantitative analysis of the product.

The analysis is in phases. The first phase involves examining the physical appearance of all the aspects of the product including packaging, labeling, drug literature and anything that may be at variance with good manufacturing practice standards.

The next phase had to do with determining whether the product we were analyzing actually contains the active ingredients of co-trimoxazole.  We conducted the test and the results confirmed that the tablet analyzed contained indeed co-trimoxazole. In this particular test, the color of the final solution at the end of the test was to match a given colour in the test manual. A parallel disintegration test was also carried out.

Performing a test in the PCC quality control lab in Limbe

We proceeded to the next step using thin layer chromatography to determine whether the active ingredients of the sample we were analyzing were present in the expected proportion. At the end of the test, one of the two ingredients of the product was okay while the other seemed to be deficient. The PCC pharmacist told me that a result like this implies that a second test be carried out to confirm the deficiency. If at the end of the second test, the same result emerges, the sample will be sent to the Difaem lab in Germany or to a World Health Organization (WHO) certified laboratory in Kenya for more sophisticated confirmatory test.

If the final result confirms the drug to be substandard or fake, an alert will be sent out throughout the Difaem network and other WHO outlets to warn practitioners of that particular batch of a specific product.

There is a need to encourage those that are taking different actions at different levels to prevent counterfeit drugs from killing people and killing the medical and allied professions.

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