20 February 2013

Namibia Clear of Fake TB Drugs

NAMIBIA has not reported any incidents of substandard or falsified tuberculosis drugs which, according to an international report, is widely used in at least 17 countries, including southern African states.

"To date we have no evidence of any substandard anti-tuberculosis medicines in Namibia. Nevertheless, vigilance is necessary, since at times unregistered medicines may be illegally brought into the country and find their way into mainly the informal market," said the deputy permanent secretary of the Ministry of Health and Social Services, Dr Norbert Forster.

In a study published this month in the International Journal of Tuberculosis and Lung Disease, Dr Roger Bate and his colleagues at the American Enterprise Institute reported that they had tested 716 samples of two tuberculosis medicines, isoniazid and rifampicin, which comprise a standard TB treatment regime.

These samples were bought from pharmacies in 17 countries in Africa, Asia, Europe, and Latin America. These countries are Angola, Brazil, China, the Democratic Republic of the Congo (DRC), Egypt, Ethiopia, Ghana, India, Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, Tanzania, and Zambia.

Across all countries, 9,1 percent of the samples were found to be substandard and falsified. In Africa, 16,6 percent were falsified. The researchers of the study said the use of these substandard medication likely contribute to the rise in drug-resistant strains of the disease.

"Record numbers of people are contracting drug-resistant TB, and those numbers are rising worldwide. We don't understand the extent to which poor quality drugs are contributing to this epidemic, but it has it been a policy priority to figure it out," said Dr Bate, who led the study.

He said the study's data represent conservative estimates and should sound a warning to public health officials.

"If we don't address the issue of drug quality, particularly in India, China and African countries where the rates of TB drug resistance are accelerating, years of progress against the disease could be undone," Bates said. He encouraged public health officials and developmental agencies to conduct further research into the quality of TB medicines and its relationship with rates of drug resistance.

Forster last week said all anti-tuberculosis medicines distributed by the ministry's central medical stores (CMS) are procured on the basis of competitive tender.

"Part of the tender requirements is compliance with international quality manufacturing standards," Forster said.

All medicines procured by CMS must be registered with the Namibia Medicines Regulatory Council (NMRC), which Forster said has a rigorous procedure in place to ensure that only quality medicines are distributed in Namibia and regularly tests samples supplied by the manufacturers.

In addition, he said, all medicines received by the CMS are quality tested locally through the ministry's medicines quality assurance laboratory before distribution to hospitals and clinics.

For private pharmacies in Namibia, the same applies, Forster said. This means that all medicines imported to further dispensing in Namibia must be registered with the NMRC, which further inspects all private pharmacies regularly to maintain prescribed quality standards.

Forster went on to say that all tuberculosis patients receiving care from state facilities are included in the ministry's electronic tuberculosis patient register and are regularly followed up during their standard six-month treatment.

Cases that do not improve on standard treatment regimes have further medical investigations done. At times the results then necessitate a change of medication.

He said the fact that quality-assured tuberculosis medicines are widely and regularly available for free through the ministry's facilities and given that all Namibian TB patients are on the ministry's TB register and regularly followed up in line with the ministry's standard TB treatment guidelines, strongly contribute to risk reduction.

"All Namibian clinicians who treat TB patients are however called upon to remain vigilant and to especially review TB cases that do not improve on standard treatment within the prescribed time frame," Forster said.

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