A PHARMACIST has warned that the proposed policy implementation announced by Minister of Health, Prof. Eyitayo Lambo for introduction of Artemisinin-based Combination Therapy (ACT) as the drug of choice for treatment of malaria in the country may not achieve its desired purpose except there is complete sanitization of the nation's chaotic drug distribution system, even as a top government researcher has denied reports that use of chloroquine for treating malaria has been banned in the country.

Making this observation in the wake of the announcement of the new health policy shift, Chairman of the Lagos State branch of the Pharmaceutical Society of Nigeria (PSN), Mr. Olumide Akintayo, said the continued existence of open drug markets and other unregistered drug outlets was bound to be inimical to the ultimate aims and objectives of the new policy irrespective of reasons that may be adduced to justify the replacement of chloroquine as the existing first line drug for malaria treatment in the country,

In an exclusive interview with Sunday Vanguard, Akintayo acknowledged that although the problem of resistance being experienced with chloroquine therapy was enormous and necessitated a review, there was an urgent need to resolve once and for all, the knotty issue of the open drug markets.

His words: "There is nothing wrong with the new malaria treatment policy, but what we are saying is that irrespective of any policy formulation, there is still the danger of people continuing to develop drug resistance if more emphasis is not put on securing the proper handling and distribution of drugs. The issues connected with this matter are multiple; they go beyond merely changing the drug of choice for malaria treatment. The biggest problem has to do with the riotous drug distribution system that is the bane of the health sector. Government must see the need to streamline the current drug distribution policy if we are to expect any progress in this direction."

Recalling that the Lagos State branch of the PSN had waged series of campaigns against open drug markets, Akintayo remarked that the continuous existence of illegal drug outlets is creating problems not just for Nigeria but the entire world. "It is an immense problem and a deluding process to sit and just watch things as they are. The real issue to be tackled is the open drug market. A situation in which anybody can have access to antibiotics and drugs does not augur well as it is bound to encourage the problem of resistance.

"We need to begin to ask questions as to why these illegal outlets continue to thrive. Why is it impossible to dismantle them? We need to know why the National Agency for Food and Drug Administration and Control (NAFDAC) has been unable to dislodge them. Certainly there is the need for a discourse by all stakeholders.

These should include government, the Pharmaceutical Manufacturing Group of the Manufacturers' Association of Nigeria (PMG-MAN), importers and the Pharmaceutical Society of Nigeria as the umbrella body for pharmacy practice in the country. They should come together to jointly review the totality of the situation in order to take things forward," the pharmacist said.

Admitting that within the current dispensation, chloroquine has no therapeutic advantage especially in adults in whom about 600 mg chloroquine base is required, Akintayo pointed out that most chloroquine tablets contain far less than the specified quantity of the active ingredient. "We have seen situations in which tablets contain less than 200mg. Such tablets when taken are bound to be less active and constitute under dosage. Then there is the question of adulteration and faking. Let us take metronidazole for instance.

This is a drug that has the same physical characteristics as chloroquine, but because it is cheaper, it is often passed off as chloroquine. Our concern is that government must realize that when these spurious formulations are administered, there is bound to be treatment failure. The totality of not addressing these issues is that it will continue to encourage treatment failure."

Analyzing the situation further, he highlighted other drawbacks of a chaotic drug distribution system: "Chloroquine is an over-the-counter (OTC) drug and if we are going to use the ACTs as first line treatment drugs, then of course they must also be available as OTC in which case, the counseling of a pharmacist is required in dispensing it. Noting that the Transition Committee set up to see to the smooth coordination and implementation of ACTs as drugs of choice for treatment of uncomplicated malaria in Nigeria is a step in the right direction, the PSN boss advocated that only the right people should be appointed to constitute the committee.

Calling for a situation in which government would begin to link health with the economy, he noted that the policy must be weighed in the direct nature of the malaria burden in the country. "Malaria accounts for about 60 per cent of clinical disease cases in the country. In a population of about 130 million, it follows that at least 80 million people need treatment per year. We must see if we can plant the raw material in the Nigerian environment and know whether it will thrive, or whether we have requisite technology to produce the drugs and make them available and affordable and if indeed investors would be interested in helping to develop the technology. We have a national drug policy that should investigate whether ACTs have a safety profile for children since most of the malaria cases we have are paediatric cases. This is important if we are not to negate the spirit of the drug policy."

In a related development and contrary to reports making the rounds, it has been revealed that the Federal government has not banned chloroquine as the first line drug for treatment of malaria in the country. Disclosing this in a chat with Sunday Vanguard, the Director Research and Coordination, Nigerian Institute of Medical Research (NIMR), Prof. Philip Agomo said the true position is that chloroquine is to be gradually phased out.

"I think the Minister of Health was misquoted. Chloroquine has not been banned; people are still using it and recovering from malaria, so it is not banned, it is only being phased out gradually as a change of policy in line with recommendation by the World Health Organization (WHO). Yes it has been the first line drug of treatment while sulphadoxine-pyrimethamine (Fansidar) was the second line drug, but there are now malaria parasites in some geo- political zones of the country that are choloquine resistant and so it is being replaced with the ACTs which is a new combination."

Agomo, also a member of the National Malaria Committee was optimistic of success of the new therapy. He revealed that findings from tests conducted on the two combination drugs (artemeter/lumefantrine and amodiaquine/artesunate) showed that the ACTs are better.

Reacting to fears concerning the higher cost implications of the new drug regimen, he said it was a matter of choice. "If we say that ACTs are too costly then we should look at the possible implications of the drug that is cheaper but has lost efficacy. How much does that really cost? We know the ACTs will be expensive, but the objective is to have a drug that works. My hope is that the ACTs will be as available and as affordable as chloroquine."

In his response, the researcher noted that more deliberations would be carried out during the upcoming National Council on Health (NCH). "For now we are still importing, but now that the Federal Ministry of Health has waded in and there is a funding body, there is hope that local production will soon be achievable. The Minister has asked the manufacturing bodies to begin manufacturing of the drugs. The National Institute of Pharmaceutical Research (NIPRD) will cultivate the plant Artemisinin annua so that it can be available in large numbers for production of more drugs. But for now we are importing."

Meanwhile NAFDAC has acknowledged the essence of the new malaria treatment policy. Stating the agency's position, the chief public relations officer, Mr. Abubakar Jimoh said: "We are a parastatal under the Ministry. The minister has spoken and we have nothing to add. We are toeing the line of the Ministry, Our efforts are aimed at perfecting the process."

Drug resistance situation

The NAFDAC official noted that as a response to the antimalarial drug resistance situation in Nigeria and other malaria endemic countries, the WHO recommends that treatment policies for falciparum malaria in all countries experiencing resistance to single therapies should be changed to combination therapies, preferably those containing an ACT.

Sources within the Health Ministry said last week that in accordance with the therapeutic options currently recommended by WHO, four regimens of ACTs were approved. They are artemether/lumefantrine, artesunate/amodiaquine and artesunate/sulfadoxine/pyrimethamine. Others are amodiaquine/sulfadoxine/pyrimethamine and artesunate/mefloquine.

The current WHO policy on antimalarial treatment is based on the recommendations and conclusions of two consultations of international experts on malaria chemotherapy, held in November 2000 and April 2001. Since the WHO recommendation was issued, at least 20 countries (seven in Africa) have updated their treatment policies to include ACTs as first-line or second-line treatment of malaria. This was made possible largely with the participation of RBM partners and increased mobilization of international funding.

The Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM) established in 2002 which has become one of the main international funding mechanisms to support the implementation of highly effective interventions for the control of malaria and the other two diseases in endemic developing countries is also significant. It has become the largest financial supporter of ACTs in the world.

Since it was established, over US$30 million has been committed over the full five-year life of GFATM Board-approved proposals from African countries for the purchase of ACTs in three proposal rounds. As a result of flexibility in the use of funds committed to these programmes, even more funds may be allocated to purchase ACTs as countries continuously evaluate their drug policies and how to best utilize grants from the GFATM. By adopting the ACT-based policy, Nigeria is toeing the line of a number of recipient countries in Africa, which originally requested funding for chloroquine,but have either completed or are in the process of re-evaluating their drug policies towards the use of ACTs.

These countries include Senegal, Ghana, Benin, Mali, Chad, and The Gambia. In addition to the GFATM, national governments and RBM partners, such as UN organizations, bilateral agencies and NGOs have also contributed to the sourcing and financing of ACTs.Also to facilitate access to ACTs, WHO has, in collaboration with UNICEF, established a system for pre-qualification of manufacturers of artemisinin derivatives. It has also negotiated price agreements with manufacturers, engaged in international procurement, and set up systems of pharma-covigilance.

A key aspect of implementation of an antimalarial treatment policy recommended for developing countries by WHO include effectiveness of the proposed treatment, adherence to the treatment as well as efficacy within the real constraints in a health care system.

Some government policy decisions may have a negative impact on pharmaceutical access. Amongst these are key policy elements that influence the level of access, rational drug selection and use, affordability, allocation of resources and reliable health and supply systems.

It is recognized that there are regional differences in patterns of anti-malarial drug resistance in countries and policy options should reflect these differences. Previous documentation has suggested that a therapeutic failure rate of 25 per cent is a useful indicator for change in anti-malarial treatment policy. The decision to change depends on such country's circumstances.

On the average, it is known that the time required to implement a change in policy is usually two to three years, and it is recommended that evaluation of potential alternatives should begin as soon as failure of the specific drug starts to emerge.

The potential value of drug combinations, notably those including an artemisinin derivative, to improve efficacy, delay development and selection of drug-resistant parasites and thus prolong the useful therapeutic life of existing antimalarial drugs is widely accepted.

The bottom line is that there is an urgent need for field research, linked to appropriate pharmaceutical product development, to assess the effectiveness of potential combination therapies that include artemisinin and its derivatives in different epidemiological and health system settings in malaria endemic settings.

In the most malaria endemic countries, the use of chloroquine as a single first-line drug treatment is now increasingly limited following the evolution of chloroquine-resistant Plasmodium falciparum., However, it remains the first-line drug of choice in most countries where acceptable clinical cure rates can be obtained. In areas where choloroquine is still used as a first-line drug, high rate of clinical failures is evident in the general population, and a more effective first-line treatment has become desirable for vulnerable groups such as young children and pregnant women.

But this desirability is to be balanced against logistic and acceptability problems. In some areas chloroquine use is being potentially extended by its combination with other anti-malarial drugs, in order to take continuing advantage of its antipyretic and anti-inflammatory effect.