Posts or Comments 15 July 2024

Drug Quality Bill Brieger | 25 Jul 2009 07:22 am

Vigilance for the malaria drug supply – never ending

Malaria drug supplies provided by or purchased through major donor programs like the Global Fund, World Bank Booster, and the US President’s Malaria Initiative are safe and of high quality, at least upon arrival at ports in endemic countries. We still need to monitor storage conditions and shelf life. While these sources of malaria medicine are substantial, especially in providing for the public sector, there are huge variations of drug type, formulation and quality available to the average consumer in endemic countries.

Major donors rely on efforts to screen the mass of medicines available for malaria by the World Health Organization that has a medicine ‘prequalification’ program with the following mission:

In close cooperation with national regulatory agencies and partner organizations, the Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

At present there are three prequalified providers of the popular artemether-lumafantrine (AL) combination: Novartis Pharma  of Beijing, China and Suffern, USA, Ajanta Pharma Ltd of Paithan, Aurangabad, Maharashtra, India, Cipla Ltd of Patalganga, India.  The National Agency for Food and Drug Administration in Nigeria has approved AL from twelve pharmaceutical companies, only two of which is prequalified.

One can see that the market for anti-malarial drugs is huge, and not even government approval can always solve the quality problem. Recently Gatonye Gathura and Mike Mwaniki of the Daily Nation reported that in Kenya , “A number of children’s malaria medicines on the Kenyan local market contain organisms that cause disease. Seven of about a dozen anti-malaria  suspensions on sale in Nairobi and registered with the Pharmacy and Poisons Board also dissolve poorly in water. A study published in Malaria Journal says that although dry powder suspensions are few because the active ingredient artemisinin is not stable in solution form, those available are of poor quality.”

Suspensions are easier to administer to children. Unfortunately the Kenyan researchers also found that, “paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient.”

News reports from Cambodia show that the malaria drug problem is a world-wide concern. “Many of the drugs are cheaply made and don’t contain the right chemistry, or are stored at incorrect temperatures, while others are deliberate fakes that have authentic-looking pills and packaging but contain only a small percentage of the active ingredient in each pill,” according to Talea Miller of Online NewsHour.

We cannot allow the caveat “Let the buyer beware” serve the global malaria control effort.  Maybe as donor contributions of quality drugs flood the market, the unsafe and ineffective formulations will be driven out. But unless national food and drug boards take their role more seriously and collaborate with the malaria community, the threat of fake and substandard drugs will continue to threaten lives now and stimulate drug resistance that threatens future generations.

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