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Wednesday, February 10, 2010

Look beyond treatment-Uganda scientists on US antimalarial drug quality study

By Esther Nakkazi

This week the US published a report from a study on the quality of anti-malarial drugs in Uganda and other African countries.

But Uganda scientists have different opinions saying although the study was good and relevant, there are more pressing problems with malaria, which kills at least 300 people, per day, mostly children under five years and pregnant women in Uganda.

Some Uganda scientists think the study was a 'commercial ploy’ by the malaria industry but all agree there is a bigger problem than impure drugs. They pointed out that the resistance problem for malaria drugs is more of a bad consumer behaviour problem rather than purity of drugs.

In Uganda, drug resistance is manifested because many people misuse drugs properly rather than taking low quality anti-malarials. Dr. Myers Lugemwa, officer in charge of malaria research at the ministry of Health said even if it sounds like common sense but the fastidious behavior of patients  probably caused by ignorance and cultural beliefs brings about drug resistance.

He said many patients seeking treatment have cheeky behaviors like ceasing to take medicines when they feel better and sharing medicines with neighbors and friends.

So for Uganda and many other countries the issue of quality of drugs is not a primary concern but accessibility.

“We are only taking what is available, we can not just have people die because the drugs are not good quality. We have tested them and found them effective,” said Dr. Lugemwa.

National Drug Authority (NDA), the Uganda regulatory body officials said they test all the drugs that come to the market and they are dealing with counterfeits on the market but the laboratories are registering a downward trend in quality testing failure over the past decade.

“There has been a drop in drug failure rate in our laboratories over the last 10 years. But there are problems with consumers due to self medication, incomplete doses and as a result drugs become ineffective,” said Fredrick Ssekyana, the spokesperson for Uganda National Drug Authority (NDA).

The reactions follow the release of a report that said that the most effective type of malaria-fighting drugs sold in three African countries including Uganda are often of poor quality, raising fears of increased drug resistance.

Between 16 per cent and 40 per cent of artemisinin-based drugs sold in Senegal, Madagascar and Uganda failed quality testing, for reasons including impurities or not containing enough active ingredient, the survey found.

'I am alarmed by these results because it means there are many cases of malaria that are being only partially treated, and that just guarantees acceleration of artemisinin drug resistance.'— Rachel Nugent, Centre for Global Development

The study was the first part of a 10-country examination of antimalarials in Africa by the U.S. and the World Health Organization.

Artemisinin-based drugs are the only affordable treatment for malaria left in the global medicine cabinet. Other drugs have already lost effectiveness due to resistance, which builds when not enough medicine is taken to kill all of the mosquito-transmitted parasites.

If artemisinin-based drugs stop working, there is no good replacement and experts worry many people could die.

"It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active [ingredients] or the presence of impurities in the product," said Patrick Lukulay, director of a nongovernmental U.S. Pharmacopeia program funded by the U.S. government, which conducted the survey. "This is a disturbing trend that came to light."

NDA officials said they also have a problem with increasing drug counterfeits on the market, which is a global evil, but it is working with Interpol to curb the vice.

“We have people who change expiry dates, drug labels and even make pills using cassava flour,” said Ssekyana.

The three-country report also found bad drugs in both the public and private health sectors, meaning governments — some buying medicines with donor funds — are not doing enough to keep poor-quality pills out.

All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 per cent of the artemisinin-based drugs in Senegal failed.

"There are countries where donated medicines are not subjected to quality controls, they're just accepted," said Lukulay. "There are countries in Africa where Chinese products have been donated and found to be unacceptable later in the public sector."

Donations come in during epidemics or seasonal disease outbreaks, simultaneously and generously, and they are accepted by non-governmental and faith-based organizations unconditionally, according to NDA officials.

“We urge that the donations are subject to the same tests but we usually re-export or destroy them and the costs are borne by those who donate them,” said Victoria Birungi Kwesiga, inspector of drugs at NDA.

Nearly 200 samples underwent full quality control testing in a U.S. laboratory to examine the amount of active ingredient present and drug purity. For both drugs, 44 per cent from Senegal failed the full quality testing, followed by 30 per cent from Madagascar and 26 per cent from Uganda.

“I think this is a commercial ploy to discredit other drug companies super ceding others,” said a pharmacist in Wandegeya a suburb in Uganda.

“They should look beyond treatment to prevention. Recently I heard in the media that Uganda mosquitoes are resistant to DDT, they should focus on the parasite,” said Rhona Nankya a nurse in Kampala.

In all three countries, the antimalarial brands collected from various areas and sectors tended to either do well across the board or poorly, which could prove helpful for governments working to ban low-grade drugs.

Results from the other countries surveyed — Cameroon, Ethiopia, Ghana, Kenya, Malawi, Nigeria and Tanzania — have not yet been publicly released by the WHO.

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