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Pharmacovigilence &Treatment Bill Brieger | 02 Jun 2009 06:50 am

Guarding malaria drug quality in Nigeria – from port to store

The Nigerian Tribune reports today that, “A clearing agent(names withheld) has been apprehended by the National Agency for Food, Drug Administration and Control (NAFDAC) over his involvement in the importation of fake malaria drugs (Maloxine and Amalar tablets) worth N32.1million.”

maloxine-and-amalar.jpgThe fake products were produced in China but labelled “Made in India,” according to NAFDAC.  Their lab tests showed that these supposed sulphadoxine-pyrimethamine (SP) products lacked the pyrimethamine.  The Tribune quoted the NAFDAC boss as saying that, “the seizure was significant in view of the emergence of resistance strain of malaria parasites, saying the use of the fake drugs might lead to treatment failure, anaemia and death if no effective drug was given after.”

Ironically, these two SP products should not be imported for treatment, since studies dating back five or more years have shown a growing SP resistance. At present the national malaria drug policy recommends only artemisinin-based combination therapy (ACT) for treatment, while reserving SP for intermittent preventive treatment in pregnancy.  The fact that people are still demanding SP products for treatment shows lack of success in educating providers and consumers about the correct medicines as published in 2005 within the drug policy.

At the other end of the malaria drug spectrum, the Registrar of the Pharmacists Council of Nigeria (PCN) worried that unless patent medicine shops are “fully registered and regulated, the health of the people in the state will continue to be in jeopardy.” The PCN Director said that, “training (of PCN staff), which began in 2004 was informed by the council’s desire to train and retrain its staff on transmission, storage and general management of vital records.” It is not clear when and if PCN actually intends to offer training for the medicine shop owners and clerks.

The Tribune also reports that in an effort to comfort parents whose infants are experiencing what they perceive as ‘teething problems’, makers of commercially sold teething mixtures will include “very low doses of anti-malaria, especially those produced here in Nigeria or in the tropics. They also have pain relievers. However, we do know that malaria is not treated or prevented that way in children.” Since these mixtures may not be registered to treat disease, they may not be adequately regulated – and not surprisingly have led to the deaths of many children recently.

A scoping study by Nigerian researchers from the University of Ibadan has shown that patent medicine vendors (OMV) do need more education on the products that they sell – especially a full orientation on the current national malaria drug policies.  They continue to sell the more of the old first-line drugs, chloroquine and SP, instead of the recommended ATCs in large part because their customers cannot afford the new medicines. The researchers have recently called together key policy makers and donor partners to address the PMV question and find ways to improve their practices. We look forward to learning what was achieved.

In the meantime, Nigeria is among the first applicants to the new Affordable Medicines Facility – malaria (AMFm). AMFm “enable countries to increase the provision of affordable ACTs through the public, private and NGO sectors.” AMFm also “will reduce the manufacturer sales price of ACTs to public, private and not-for-profit sector buyers.” This will be an ideal way to ensure that quality ACTs are available to the public at a price they can afford from whichever outlet is most convenient.  AMFm will not succeed though without proper education and training of all providers, including PMVs and the public at large.

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