Fake malaria drugs on sale
May 17, 2008
MORE than a third of the anti-malarial medicines sold in Kampala are either counterfeit or are not strong enough to cure the disease, a survey has revealed. Because of this, scientists warn, malaria could easily become resistant to the new generation of medicines that have replaced chloroquine.
By Charles Wendo
More than a third of the anti-malarial medicines sold in Kampala are either counterfeit or are not strong enough to cure the disease, a survey has revealed.
Because of this, scientists warn, malaria could easily become resistant to the new generation of medicines that have replaced chloroquine.
“We did not quantitatively estimate the public health impact of this crisis, but it must be staggering,†the researchers wrote in the online journal Public Library of Science last weekend.
Should malaria become resistant to the new drugs, the researchers warn, sub-Saharan Africa could suffer another surge of the disease, as was the case in the 1990s.
“Substandard drugs not only endanger lives today, but also jeopardise future malaria treatment strategies by accelerating parasite resistance,†said Roger Bate of the American Enterprise Institute, who led the research.
In the study, research assistants posing as ordinary customers bought various anti-malarials from randomly selected pharmacies in Kampala.
They found that 35% of the drugs sampled were either fake or had less quantities of ingredients than required. Similar tests were done in Ghana, Kenya, Nigeria, Rwanda and Tanzania.
Kenya appeared to have the highest percentage of inefficient drugs (38%), followed by Uganda and Ghana (35%), Rwanda (33%), Tanzania and Nigeria (32%).
The drugs sampled were sulfadoxine-pyromethamine (commonly known as fansidar), amodiaqine (commonly known as camaquin), mefloquine, artesunate, artemether, dihydro-artemisinin and artemether-lumefantrine (commonly known as Coartem).
Overall 48% of the sub-standard drugs were made in Africa, while 32% were made in Asia. Contrary to popular belief that European drugs are of high standards, the researchers found that 24% of the sub-standard drugs were of European origin.
Even expensive drugs were found to be sub-standard. For instance, dihydro-artemisinin costs between sh8,000 and sh10,000 per adult dose, yet, two thirds of the samples were found to be sub-standard. It is not clear how the sub-standard medicines enter the Ugandan market.
The National Drug Authority (NDA) says it tests every batch of anti-malaria medicines imported into the country. Similarly, NDA says it tests every batch of anti-malarial manufactured locally.
“To find 35% of pharmacies selling sub-standard anti-malarials raises a lot of questions given the quality control measures of NDAâ€, comments Dr. Richard Odoi Adome, an NDA board member. “In the past, we asked the manufacturers and importers to give us samples for testing.
But we discovered that some would give us only good samples and sell something different. Now we take our own sample from each batch at a random.â€
Adome suspects the sub-standard medicines are smuggled into the country, bypassing NDA’s testing system. Such smuggled medicines are more likely to be found in drug shops than in registered pharmacies, he believes.
The Uganda Pharmaceutical Society acknowledges that there are counterfeit drugs in Uganda but doubts the researchers’ figures.
“NDA is very vigilant at entry points though I can’t say it is 100% perfect,†said the society’s secretary general, Swaibu Mukiibi. “I advise the public to buy medicine only from registered pharmacies.
To buy from the small shops is to abet the problem.†He adds that the public perpetuates the problem by looking for cheaper options. “Usually counterfeit drugs are cheaper.â€
Dr. Francis Epetait, shadow minister for health, thinks the researchers’ figure might be an under-estimate.
“It is not enough to test the medicines at the point of entry into the country,†he says.
The Pharmacy Bill on medicines regulation, currently before Parliament, will not solve the problem unless the Government puts in place mechanisms for routine sampling and testing in pharmacies and drug shops, he argues.
“Uganda has become a dumping ground, not only for medicines but for other products as well,†he says. “We have failed to enhance an institution that would help us in quality control.â€
A source in NDA said they do not have the capacity to do routine sampling and testing of medicines, technically called post-market surveillance. NDA has a hi-tech laboratory but not the human resources and funding that is required to go around the country sampling drugs.
The drug authority has only eight drug inspectors countrywide, regulating the over 400 pharmacies. Three of the inspectors are in Kampala and five are upcountry.
Uganda has become a dumping ground, not only for medicines but for other products as well. We have failed to enhance an institution that would help us in quality control.
More than a third of the anti-malarial medicines sold in Kampala are either counterfeit or are not strong enough to cure the disease, a survey has revealed.
Because of this, scientists warn, malaria could easily become resistant to the new generation of medicines that have replaced chloroquine.
“We did not quantitatively estimate the public health impact of this crisis, but it must be staggering,†the researchers wrote in the online journal Public Library of Science last weekend.
Should malaria become resistant to the new drugs, the researchers warn, sub-Saharan Africa could suffer another surge of the disease, as was the case in the 1990s.
“Substandard drugs not only endanger lives today, but also jeopardise future malaria treatment strategies by accelerating parasite resistance,†said Roger Bate of the American Enterprise Institute, who led the research.
In the study, research assistants posing as ordinary customers bought various anti-malarials from randomly selected pharmacies in Kampala.
They found that 35% of the drugs sampled were either fake or had less quantities of ingredients than required. Similar tests were done in Ghana, Kenya, Nigeria, Rwanda and Tanzania.
Kenya appeared to have the highest percentage of inefficient drugs (38%), followed by Uganda and Ghana (35%), Rwanda (33%), Tanzania and Nigeria (32%).
The drugs sampled were sulfadoxine-pyromethamine (commonly known as fansidar), amodiaqine (commonly known as camaquin), mefloquine, artesunate, artemether, dihydro-artemisinin and artemether-lumefantrine (commonly known as Coartem).
Overall 48% of the sub-standard drugs were made in Africa, while 32% were made in Asia. Contrary to popular belief that European drugs are of high standards, the researchers found that 24% of the sub-standard drugs were of European origin.
Even expensive drugs were found to be sub-standard. For instance, dihydro-artemisinin costs between sh8,000 and sh10,000 per adult dose, yet, two thirds of the samples were found to be sub-standard. It is not clear how the sub-standard medicines enter the Ugandan market.
The National Drug Authority (NDA) says it tests every batch of anti-malaria medicines imported into the country. Similarly, NDA says it tests every batch of anti-malarial manufactured locally.
“To find 35% of pharmacies selling sub-standard anti-malarials raises a lot of questions given the quality control measures of NDAâ€, comments Dr. Richard Odoi Adome, an NDA board member. “In the past, we asked the manufacturers and importers to give us samples for testing.
But we discovered that some would give us only good samples and sell something different. Now we take our own sample from each batch at a random.â€
Adome suspects the sub-standard medicines are smuggled into the country, bypassing NDA’s testing system. Such smuggled medicines are more likely to be found in drug shops than in registered pharmacies, he believes.
The Uganda Pharmaceutical Society acknowledges that there are counterfeit drugs in Uganda but doubts the researchers’ figures.
“NDA is very vigilant at entry points though I can’t say it is 100% perfect,†said the society’s secretary general, Swaibu Mukiibi. “I advise the public to buy medicine only from registered pharmacies.
To buy from the small shops is to abet the problem.†He adds that the public perpetuates the problem by looking for cheaper options. “Usually counterfeit drugs are cheaper.â€
Dr. Francis Epetait, shadow minister for health, thinks the researchers’ figure might be an under-estimate.
“It is not enough to test the medicines at the point of entry into the country,†he says.
The Pharmacy Bill on medicines regulation, currently before Parliament, will not solve the problem unless the Government puts in place mechanisms for routine sampling and testing in pharmacies and drug shops, he argues.
“Uganda has become a dumping ground, not only for medicines but for other products as well,†he says. “We have failed to enhance an institution that would help us in quality control.â€
A source in NDA said they do not have the capacity to do routine sampling and testing of medicines, technically called post-market surveillance. NDA has a hi-tech laboratory but not the human resources and funding that is required to go around the country sampling drugs.
The drug authority has only eight drug inspectors countrywide, regulating the over 400 pharmacies. Three of the inspectors are in Kampala and five are upcountry.
Uganda has become a dumping ground, not only for medicines but for other products as well. We have failed to enhance an institution that would help us in quality control.