Private clinics have worst anti-malaria drugs

By Mubatsi Asinja Habati

But should National Drug Authority be celebrating that?

A new report has found that 26 per cent of anti-malaria drugs in use in Uganda are substandard. That should be very bad news for a country where on average 12 people, mostly children, die of malaria every hour.

So why is there celebration over the report findings at the National Drug Authority (NDA), the body charged with ensuring that only quality drugs are used?

Apparently,  the NDA thinks the report is very favourable because it shows that Uganda has the lowest rate of substandard drugs of the three countries reported so far. It also found that 100 per cent of all malaria drugs in government health facilities were of high quality.

The study dubbed Quality of Antimalarials in Sub-Saharan Africa was a collaborative effort by the World Health Organization (WHO) and the Drug Quality and Information Program, supported by the U.S. Agency for International Development (USAID) and implemented by the United States Pharmacopeia.

The survey is conducted in Malawi, Ghana, Cameroon, Ethiopia, Madagascar, Senegal, Kenya, Nigeria and Tanzania. So far findings in Uganda, Senegal and Madagascar have been released.

In Uganda, all samples taken from the public sector passed the quality tests. Only 11 antimalaria drugs were tested.  Poor quality SPs and ACTs were found in the private sector and in the informal market.

Fredrick Ssekyana, spokesperson of NDA, boasts that government cannot procure substandard drugs.

But what about the substandard drugs found in private health facilities; is NDA not responsible for them?

There are no cases of penetration of fake drugs at the entry points where NDA has staff, says Ssekyana, the substandard drugs in private health sector might be finding their way through porous border points where NDA staff is not deployed and sometimes being counterfeited by some unscrupulous people.

Interestingly, no poor quality SP was found among the samples from the Central and Eastern regions that were tested. Poor quality SPs were found in Southwestern, Northern and Western regions. Substandard ACTs were found in all five regions.

Ssekyana urges the public to be on watch and alert the authorities of anybody involved in such bogus ventures that put the life of Ugandans at risk. He says NDA has arrested individuals who tamper with drug labels.

He also notes that storage facilities can affect the quality of the drug; arguing that some private clinics though licensed may not have the required storage atmosphere for particular drugs thereby compromising their quality standards.

“Even if you bought a standard quality drug today but stored it not according to recommended storage conditions, it would be found substandard,” said Ssekyana.

However, many of the tested drugs in private clinics lacked sufficient ingredients meaning that this had little to do with storage.

To combat malaria, the government through the Ministry of Health (MoH) constantly introduces, phases out and re-introduces drugs. The drugs sampled come in two generic forms; sulfadoxine-pyrimethamine (SP) and artemisinin-based combination therapies (ACTs).

Drugs are phased out when users develop resistance to them and they become ineffective.

 Since 2006 Uganda shifted from the use of chloroquine, fansidar, metaklelfin, homapak and SP because of perceived drug resistance to fight malaria to ACTs like Coartem, Duo-cotexcin, Lumartem, Artefan, Artequin and Lonart.

ACTs have been praised for their fast ability to clean malaria parasites from the blood stream. The government gives these drugs to Ugandans at nil cost in public health centres. Many Ugandans, however, patronize private health facilities where ACTs are a bit expensive. That is how SPs, which are cheaper, persist despite being phased out.

As a general rule, the survey found that when a brand passed or failed in one country, it would also pass or fail in other countries. This indicates that the problem of quality is created at the source, in that case, rather than during passage through the distribution chain.

Of the ACTs brands in Uganda sampled Artefan, Larimal and Duact recorded the highest failure rates. However, the study did not look for evidence of counterfeiting.

Dr George Mukone, who is the medical officer in charge of case management in the Ministry of Healths Malaria Control Programme, says the drugs that were found to lack the required sufficient ingredients could be entering into the country through smuggling.

A few of the SP samples from Uganda had small colored – spots on the tablets, for example, the Agosidar and Malarest brands, but the samples passed the QC test requirements, the report stated. It adds: One sample of the ACT brand, Artefan, had brown-colored spots on the tablets; that sample failed the QC test requirements. This suggests that, at a very basic level, a careful visual inspection of the packaging and product can be useful in identifying products for further testing and confirmation of the product quality.

The report observed significant differences in the quality of ACTs across various brands. Some brands were consistently of good quality, while others were consistently substandard.

Authors of the study conclude that they have provided more specific data on which types of antimalarials are more or less problematic, as well as which brand, in which region, and in which sector.

These findings present an opportunity for the countries to take targeted corrective actions, says the report, adding that: to continue to strengthen their quality assurance systems, and to close loopholes that may exist in their current regulatory framework.