Nigeria bans chloroquine
December 28, 2006 | posted by Nigerian Muse (Archives)



Guardian
January 25, 2005

Govt bans Chloroquine for malaria treatment
By Ben Ukwuoma

IN a major policy decision that will alter the treatment of malaria in the country, the Federal Government yesterday announced the ban of Chloroquine and Sulfadoxine - Pyrimethamine as first line drugs in the treatment of the ailment.

Minister of Health, Prof. Eyitayo Lambo, who disclosed this at the interactive meeting between the ministry and stakeholders` on the change of Malaria Drug Policy in Lagos, cited increasing evidence of drug resistance, which has led to treatment failures.

Malaria, according to statistics from the Federal Ministry of Health, is responsible for 60 per cent of outpatients' visits, 30 per cent of childhood mortality, 25 per cent of infant mortality and 11 per cent of maternal deaths. About N132 billion is said to be lost yearly in form of treatment costs, prevention, and loss of man-hours.

Lambo said the new Malaria Drug Policy would now adopt the use of World Health Organisation-recommended Artemisinin-based Combination Therapy (ACT). "These ACTs are highly efficacious, though more expensive than Chloroquine. However, we have little choice considering the cost from repeated treatment of malaria due to resistance to Chloroquine and associated progression to severe malaria and consequent loss of live," he said.

"The selected ACTs are co-formulated artemeter and lumefantrine and Artesunate/amodiquine, which is presently available in co-packaged blisters," he added.

"Evidences have shown that the first line drug, which is Chloroquine has lost its efficacy due to the emergence of chloroquine-resistant strains of Plasmodium falciparum. This trend was noticed in 1987 in the southeastern part of the country.

The incidence of adulterated, fake, substandard drugs and poor malaria treatment compliance has led to rising treatment of typhoid cases due to misdiagnosis of failed malaria treatment."


"The result of the drug efficacy tests, he said, showed treatment failures up to levels that necessitated drug policy review.
 

World Health Organisation (WHO) guidelines stipulate that adequate clinical and parasitological response levels less than 75 per cent should be addressed by drug policy review.


But Lambo said the results recorded within the zones showed a national average of 39.2 per cent for Chloroquine, which necessitated a review of anti-malaria treatment policy in Nigeria.

He noted that the wave of resistance to Chloroquine has over the decades swept through the East and Central Africa leading to drug policy review in those countries. "Recently, this same trend has been documented in West African countries and several West African countries including Ghana have reviewed their drug policy adopting the use of the World Health Organisation - recommended ACT."
He explained that the decision to change the anti-malaria treatment policy and the subsequent implementation of the policy brings with it challenges and complexities at every level, involving a variety of stakeholders, including manufacturers and private providers. "The introduction of these new drugs must, therefore, be done in an articulated fashion duly collaborating with relevant organisation.

"Currently, these ACTs are only being produced abroad. However, the adoption of ACTs is not to sideline the efforts of our local drug manufacturers. Indeed, the present administration is promoting local production of drugs. Therefore, my ministry is ready to support any pharmaceutical company that is ready to work towards the production of ACTs locally.

"I am informed that the plant Artemisia anua, from which artemisinin is synthesised can be cultivated locally. This will be another major breakthrough if achieved, considering the enormous volume of drugs that will be required by the country annually."
National Malaria Programme Co-ordinator, Federal Ministry of Health, Dr. T. O. Sofola, said WHO recommends that treatment policies for countries experiencing on her part resistance of more than a level of 25 per cent to monotherapy should consider combination therapies preferably artemisinin-based combination therapy - ACT".


According to her, the rationale for change is to protect individual drugs against occurrence of resistance, rapid resolution of clinical symptoms, effective action against multi-drug resistance to P. falciparum, and decrease transmission. She added that "malaria is a highly treatable disease and very effective treatment is available in form of ACTs. Nigeria must accelerate access to ACTs and make these life-saving medicines affordable to the people in need."


However, manufacturers under the umbrella of Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN) have criticised the policy, raising posers on current process of policy change. For instance, they wanted clarifications on the safety profile of the ACTs in Nigeria, the life span of the malaria drug policy, and which products are first line and second line for malaria treatment in the country.

In a paper presented by the chairman, Mr. Emmanuel Ebere, the group is demanding that the effective implementation of policy should be shifted to January 1, 2007. They also want it to be restricted to the Public Sector. The group is also demanding that the patent rights on Lumefantrine and Artmether be voluntarily surrendered by holders on humanitarian grounds, as well as reduction on tariff of the drugs.

Prof. Emmanuel Ezedinachi, an Epidemiologist and WHO consultant however, defended the policy, insisting that the sample size used to investigate the efficacy of Chloroquine and other anti-malaria drugs was a true reflection of the picture. He said: "We used a total of 600 patients from six centres in the country, which is more than significant".

He urged pharmaceutical companies in the country to participate actively in efficacy trials to confirm the funding.

But the Managing Director, Neimeth International Pharmaceuticals, Mazi Sam Ohuabunwa, countered that "we are not quarrelling about the efficacy of the drugs, but we are talking about the major disease area. Any policy that must be introduced should be done in a measured manner to ensure compliance. An essential drug is one that is used for a greater number of people available at all times in the right quantity and is affordable to a greater number of people. The drug we are talking about is neither available nor affordable. In fact, it is limited in supply. The policy will cause a lot of problem to the patients".






 

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