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Malaria Drugs -Confusion galore?

By EUNICE MENKA, GHANA


Ask 10 people on the streets of Ghana's capital, Accra, their choice of a drug to treat malaria. Ten different anti- malarials are likely to come up, both single and combination drugs. Eunice Menka, from Ghana, went to town to find out what is happening.

“I still take chloroquine and I have found it very effective in curing my malaria,” Mr Kofi Amarh, a Public Servant working with a government agency in Accra, says. He knows about the newly introduced first-line combination therapy, artesunate-amodiaquine by the Ministry of Health.

Two months ago, however, Mr Amarh entered a pharmacy shop to ask for chloroquine but the pharmacist had no stocks available.

Many Ghanaians still use mono- therapies such as alaxin and artesunate, despite the change to combination drugs because of doubts, habits and poverty. Mr Nelson Aklamanu, a Pharmacist at  the Palace Pharmacy at Danquah Circle in Accra, says people still come over to ask for chloroquine. The drug is the cheapest among the many anti-malarials. Others however go in for chloroquine not only because of the cost but they claim it is still effective when they use it.

The big confusion raging on within the communities is: Which anti-malarial is efficacious?

Majority of malaria sufferers in the country do not visit health facilities at the onset of the disease. They prefer seeking treatment at the community drug shops and pharmacies. Others would rather begin with self medication first.

Ghana's statistics put malaria as being  responsible for 40 per cent of all Out  Patients' Department cases but the  disease is a disease of the community. People prefer to manage it at home, especially if they have to queue at the health facility, spend more time and resources in accessing treatment.

This situation can be chaotic for people  seeking relief from malaria as they find themselves faced with a variety of drugs to choose from to manage the condition While some people still believe in their “good old chloroquine” others believe the newly introduced anti-malarials, with all kinds of designer brand names are the best.

Chloroquine has failed in most African  countries and the World Health Organization has asked that countries go for a combination of an artemisinin and other anti-malaria drugs for the treatment of malaria. Hence there is an official drive towards artemisinin-based combination therapy or ACTs on the continent.

The four ACTs recommended by the WHO for Africa are: artesunate-fansidar, artesunate-amodiaquine, artesunate- m e f l o q u i n e a n d a r t e m e t h e r - lumefantrine, known also as coartem. Eighteen countries including Ghana, Cameroon, Liberia, Sierra Leone and DR Congo, have opted for artesunate- amodiaquine, as a first line malaria drug while 21 countries including Kenya, South Africa, Mali and Nigeria have gone for artemether-lumefantrine.

As always, big drug companies are having a field day pouring different anti- malarials on to the African market amidst the raging confusion, as patients are left on their own to wade through a maze of confusing anti-malarials.

Mr Aklamanu, however, says variety is needed to give options to people who react differently to drugs.

Already, there have been some compliant from a section of the adult population of Ghana of adverse drug reaction because of artesunate Amodiaquine, a first line drug for malaria treatment.

Mr Aklamanu says most adult patients who visit his pharmacy, opt for other  malaria drugs, especially coartem because of adverse effects of sleeplessness, palpitation and weakness, they experience after taking artesunate amodiaquine.

He says when anyone walks into the pharmacy asking for an antimalarial, he would usually give out a brand of artemether lumefantrine although it is comparatively expensive it is quite effective with little side effects as compared to artesunate amodiaquine. Mr Aklamanu says he has to stay in business and not drive away customers because of the many complaints from clients about the drug.

Surprisingly, he says children do not react adversely to artesunate amodiaquine. “It is well tolerated in children. It should be possible to set up a trial into why children experience little side effects as compared to adult patients when they go on artesunate-amodiaquine,”” he says.

People in Africa do not only have to contend with confusion in the midst of a variety of anti-malarials. There are also questions of quality, safety and efficacy to deal with, for both imported and locally manufactured anti-malarials. These problems, if not dealt with head- on, could result in more trouble, more resistant strains, more ill health, and loss of man-hours in managing malaria.

The Food and Drugs Board (FDB) in Ghana, has its hands tied. It only regulates the safety, efficacy and quality of drugs in the country and has no legal power to stop the manufacture or importation of any number of anti- malarials because of the free trade environment. Besides, Ghana is a signatory to various international conventions, and has to open its borders wide to allow for free trade.

It is gratifying therefore, that the FDB is no longer registering new anti-malarial mono-therapies now, as part of the  official drive to effectively treat malaria through the use of combination drugs.

The regulatory body says the registration licenses of mono-therapies, such as artesunate, chloroquine,  amodiaquine, alaxin and halufantrine, already in the country, would not be renewed.

The action of the regulatory body is in conformity with the policy directions to phase out the use of mono-therapies in favour of combination therapies in the management of malaria in Africa.

But while FDB is carrying out its job, mono-therapies and the newly introduced combination therapies are jostling for space on community drug markets, including fake ones from neighbouring countries.

Food and Drugs Administrations across the continent appear helpless in the face of countless anti-malarial from India, Nigeria and all parts of the globe. Some health experts have already taken issue with one of the latest ACTs launched sometime ago in Morocco,
which was targeted for the African  market. The drug, asaq, a single pill, made out of artesunate-amodiaquine, has been described as an innovative product to treat malaria because it is cheap and easy to take. But worried health experts say it was launched in Africa, without rigorous scrutiny from the West, where systems are well developed. Since 2004, Sanofi-Aventis, a French pharmaceutical, has been responsible for the co-development, industrial production, registration and worldwide implementation of asaq.

Critics of asaq say developers of asaq boycotted the stiff regulatory standards of the developed world and, with speed, got approval in Morocco, based on small scientific data.

There may be a piece of good news however in the offing not only for Ghanaians but others across Africa who suffer from adverse drug reactions from artesunate amodiaquine as tests are currently being carried out on a new antimalarial in and outside Ghana. A trial to test the safety and effectiveness of a new drug, CDA, also known as lapdap-artesunate, an
artemisinin-based combination therapy ( A C T ) f o r t h e t r e a t m e n t o f uncomplicated malaria has taken off.

The Kintampo Health Research Centre (KHRC)in Ghana and other research institutions in Kenya and Tanzania are overseeing the multi-centre trial with support from the London School of Hygiene and Tropical Medicine.

In Ghana, the trial is being conducted among children aged one to 14 years in the Kintampo area of the Brong Ahafo region of Ghana.

CDA is administered as one tablet unlike the current artesunate-amodiaquine being used in the country, which is a package of two drugs. The advantage of CDA is that as one tablet it is less complicated to administer and comply with.

Coartem is the only available one-dose ACT in Ghana and CDA would be tested alongside coartem to demonstrate the non-inferiority of CDA in terms of efficacy. Already, the trial in Ghana has enrolled over 100 children to participate in the project. Approval to carry out the
study on CDA was sought from the Food and Drugs Board in Ghana with ethical approval from the Ethics Committee of Kintampo Health Research Centre and the London School of Hygiene and Tropical Medicine. CDA is expected to be an alternative ACT for use in Ghana if the studies prove successful.

If the full benefits of combination therapies are to be realized in Africa, then African governments must effectively tackle the political, social, economic, legal, and cultural challenges to successful implementation of the introduction of ACTs.

Having a better understanding of how these factors influence malaria treatment and policies should help in the provision of effective malaria management on the continent.

It would also help people within the community make better choices in going in for efficacious anti-malarials, if the regulatory environment is firmly in place.
 

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