WITH merely two years to meet the global targets of delivering effective, affordable protection against the debilitating disease, BEN UKWUOMA and CHUKWUMA MUANYA write that recent efforts by the international community, have led to hopes that malaria could be eliminated as a public health problem before the end of the next decade.
It is a preventable and curable disease but alarmingly only few patients in the country with the disease are getting existing effective treatment that could cure them in a few days, seven years after the World Health Organization (WHO) issued a global recommendation for countries to switch from old malaria treatments to artemisinin-based combination therapies, or ACTs.
Perhaps more worrisome is that the country has just two years of delivering effective and affordable protection and treatment to all people at risk of malaria.
From the data presented by the Federal Ministry of Health, only 27 percent of the population has access to ACTs. This means that a huge 73 percent of the population do not have access to ACTs.
Specifically, only 27.6million doses of the drug have been distributed, with about 20 million doses coming from donors since the country adopted the drug as a first line drug
Currently, about 71 percent of all treatments, mostly in the private sector are based on the inexpensive but decreasingly effectively drugs like Chloroquine (CQ) and Sulfadoxine-Pyrimethane (SP).
The new drugs, ACTs, are 10 – 40 times more expensive when sold over the counter than the old drugs which have lost their effectiveness because the malaria parasite has developed resistance to them. As a result of the high cost, many still buy these cheaper less effective drugs and currently, only one in every five patients treated for malaria has access to ACTs.
However, partnership backed by nearly 30 governments around the world, including Nigeria, last week launched a N38.250 billion ($225 million) programme to subsidise the provision of malaria drugs and help combat the disease.
The initiative, known as the Affordable Medicines Facility for malaria, (AMFm), was developed through Roll-Back Malaria (RBM) – a broad partnership of public and private institutions, such as the World Bank, United Nations Children Fund (UNICEF), the Dutch Government, the Global Fund, the Bill and Melinda Gates Foundation and the Clinton Foundation.
Essentially the purpose of the AMFm is to provide widespread financial access to ACTs and delay the emergence of resistance to Artemisinin.
The secondary purpose is also to ensure de-marketing of monotherapies currently in use, as result of perceived and sometimes scientific reasons of ineffectiveness.
Government officials who presently in Washington to fashion out modalities on how to access the fund explained that the initiative seeks to buy the ACTs from foreign pre-qualified companies at a discounted price and then sell them to the Nigerian public so that the cost would get down to between N70- N100 per treatment.
A local study indicated that ACTs were the most expensive drug for treating malaria, averaging N504 (US$ 4) per course of treatment. Chloroquine was the cheapest at 83 Naira. Monotherapy artesunates were also cheaper than ACTs.
The high cost of the product is said to a major handicap in the use of the drug in malaria treatment. Besides some medical practitioners and the Pharmaceutical Society of Nigeria (PSN) have reported serious side effects and resistant of the parasite to the drug.
Mr Tony Akhimein, President of the Pharmaceutical Society of Nigeria said: "We have alerted the ministry for quite some time on the serious side effects of some of these drugs, up till now nothing has happened. We feel it is an issue to be addressed."
But Mr Clifford Nzimako Managing director of Occulus Pharmacare Limited is blaming the rising cost of the ACTs to the fluctuating fortunes of the naira and the high tariff charged by government for the raw materials and finished products.
"Government should ensure that the essential drugs for malaria treatment are readily available and affordable by reducing the tariff from 20 percent to 5 percent as promised during last year. World Malaria Day," he said.
Dr (Mrs) T. O. Sofola National Coordinator, National Malaria Control Programme, Federal Ministry of Health, insisted that there is no concrete evidence of treatment failure arising from the development of resistance to the ACTs.
However, she noted that resistance could develop as a result of non-compliance, fake and substandard drugs and the use of monotherapies in treatment.
The Guardian investigations showed that although the ministry has banned the use of monotherapies in malaria treatment, many of the drugs are still in the market and are hugely patronized by patients.
Sofola said: "The National Agency for Food Drug Administration and Control (NAFDAC) has stopped registering them. It is only the ones that their life span has not expired. We are told that by the third quarter of this year, their registration should have expired."
Nzimako continued: "Ideally, most companies have drug reactions forms, were issues of this nature are properly investigated and appropriate actions taken. Besides, NAFDAC has pharmacovigilance department were cases of adverse drug reactions. I think the major problem facing the ACTs is non-compliance. Some patients probably because of cost, do not take the required dosage as recommended by the physician."
To Mr Joseph Odumodu, Chairman Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN), the AMFm is a laudable program that not only seeks to improve access to ACTs, save lives and discourage monotherapies.
Unfortunately, there are no Nigerian pharmaceutical manufacturers that are pre qualified to be part of the program.
"Even those that have shown interest in pre qualifying their factories have realised the huge financial outlay involved which they cannot bear alone; hence the call for government assistance," Odumodu lamented.
However, the local drug makers believe that there are some critical issued that must be considered in order to achieve the objectives of the program.
Odumodu raised a poser: "How can local private sector be part of the AMFm?"
"Cleary the scheme requires local action and commitment for success. That the scheme worked elsewhere does not guarantee the same results in other places especially in Nigeria, which does have a clearly delineated drugs distribution system. From all indications, it appears also that government has not taken full cognisance of the private sector situation, which constitutes over two-thirds of the populace. If this project is limited to the public sector, like we heard recently, it is bound to fail and woefully too," he stated.
Essentially, the AMFm is expected to provide subsidized medicines through wholesalers to the rural private market, reaching far more people then any scheme working just with the public sector.
"This is an intricate matrix system that requires extensive and in depth study before mobilisation," Odumodu said.
"Will the supply chain pass the savings on to the consumer? With such a weak drug distribution system, no one can guarantee the outcome. In addition, if the local players who already have established channels are not brought on board, they might even sabotage the project. There is also the chance that powerful traders could corner the products and determine the effective treatment cost several times over the intended price," he stressed.
He posited: "With a poor regulatory environment, how do we ensure that spurious products that can effectively compete with the proposed pricing regimen do not flood the system?"
Procurement and supply chain management is also another limiting factor. With only five pre-qualified manufacturers worldwide, and potentially five just first line buyers, the local manufacturers are worried about effective distribution especially to remote areas of the country.
"Are there structures in place to monitor effective distribution and ensure quality of products? Are there structures against any member or player who indulges in acts that could become inimical to the goals of the scheme?" Odumodu asked.
"There is also the gravest danger to the Nigerian based pharmaceutical manufacturers whose major portfolio is anti-malarial products based. What would they do whilst this scheme lasts? Close up? Here in lies the consistency in pursuing the Vision 20 20:20. How can we ensure the survival of the local industry in the short to medium terms whilst the program lasts?" he said
"We are also worried about sustainability of the AMFm. Since it is unlikely to last forever, we must have a contingency plan robust enough to ensure we do not destroy the local industry who are currently excluded from the scheme We must not lose sight of implications of a further de-industrialisation that could lead to job losses, closure of facilities," he added.
However, Health Minister Professor Babatunde Osotimehein who is leading the Nigeria delegation to the meeting in Washington said: "Government will support local manufacturers in the application process for WHO Pre-qualification to access donor funds in Nigeria and export products. A full memorandum on this will be submitted to Council soon."
A team from University of Ibadan undertook a scoping study in 12 Local Government Areas (LGAs) in three states to explore the malaria treatment market and the role of Patent Medicine Vendors (PMVs), and to look at ways to improve malaria treatment.
The team led by Professor Oladimeji Oladepo of the Department of Health Promotion & Education, College of Medicine, University of Ibadan, reported that Nigerians are not getting the right treatment. Interestingly the team identified the Patent Medicine Vendor (PMV) as the first point of accessing anti-malarial drugs (AMDs)
Ironically, Oladapo, who is also the Country Coordinator Future Health Systems (FHS) Research Programme Consortium stated in the study titled "Malaria Treatment in Nigeria: The Role of Patent Medicine Vendors" that although PMVs are the most common source of malaria treatment in Nigeria, little is known about them.
"All the PMVs surveyed identified Chloroquine as a treatment for malaria, and nearly all recognized common brands of Sulfadoxine-pyrimethamine. Two- thirds were able to identify ACTs, and Coartem brand in particular."
"Observation of PMV shops revealed an average of 5.5 different brands per store for treating malaria. Sulfadoxine-pyrimethamine was the most common drug (92 per cent of shops), followed by Chloroquine (72 per cent), with ACTs being the least in stock (9 per cent). Monotherapy artesunate drugs were more common (32 per cent)." This is troubling, because of the danger that the malaria parasite could become resistant to it," the researchers stated.
"ACTs were the most expensive drug for treating malaria, averaging N504 (US$ 4) per course of treatment. Chloroquine was the cheapest at 83 Naira. Monotherapy artesunates were also cheaper than ACTs."
The main findings of the study showed PMVs have little knowledge of the new treatment guidelines, and most government officials know little about PMVs; The National Malaria Control Programme (NMCP) is leading a process in developing a new Country Malaria Control Strategic Plan for 2009-2013. The Plan reflects Federal Government’s strategy to accelerate and intensify efforts on malaria control. The plan was developed in partnership with the States’ Ministries of Health and their LGAs, RBM partners and other stakeholders.
Osotimehin told The Guardian that NMCP aims to halve the burden of malaria by 2010; and 75 per cent by 2015, which is expected to reduce all-cause child mortality by 20 percent by 2010 and to reach near-zero deaths by 2015. Osotimehin said by this, the RBM goals and the MDGs would be achieved by 2010 and 2015 respectively.
Osotimehin said: "The Country Strategic Plan builds on a set of core as well as cross-cutting interventions. They include: At least 80 per cent of households with two or more Insecticide Treated Net (ITN)/LLIN by 2010 and sustained at this level until 2013; At least 80 per cent of children less than five years of age and pregnant women sleep under ITN by 2010 and sustain coverage until 2013; and To introduce and scale up IRS to 80 per cent household coverage in selected areas from 20 per cent in 2009 to 100 per cent by 2013 as a complementary strategy to ITN and ensuring at least 85 per cent of targeted structures are sprayed in adequate quality."
The University of Ibadan study identified new strategies for tackling these issues. They involve partnerships of PMVs, their associations, government officials and communities and may include the use of new communications and drug testing technologies.
Oladapo and his team recommended specific actions to improve the provision of quality treatment to include: Training PMVs and their drug suppliers about appropriate malaria treatment and about the potential role of insecticide-treated nets in malaria prevention; Reducing the opportunities for PMVs to supply sub-standard drugs through a combination of more effective government regulation, PMV association self-regulation, and community involvement involving; Educating communities on appropriate malaria treatment; and Increasing the roles of community organizations in monitoring drug quality. Tasks can include looking for NAFDAC registration and expiry dates and the use of simple technologies for testing drug quality or scanning product identification.
The World malaria report 2008 described the global distribution of cases and deaths, how WHO-recommended control strategies have been adopted and implemented in endemic countries, sources of funding for malaria control, and recent evidence that prevention and treatment can alleviate the burden of disease.
The Global malaria Programme (GMP) is part of the WHO, the foremost global authority on health. GMP is responsible for malaria surveillance, monitoring and evaluation, policy and strategy formulation, technical assistance, and coordination of WHO’s global efforts to fight malaria.
Recent data shows that large-scale use of WHO recommended strategies could rapidly reduce malaria, especially in areas of high transmission such as Africa. WHO and Member States have made significant gains in malaria elimination efforts. For example, the Maldives, Tunisia and the United Arab Emirates have eliminated malaria. Country successes are due to intense national commitments and coordinated efforts with partners.
WHO recommends: prompt treatment for all episodes of disease (within 24 hours of the onset of symptoms if possible); use of insecticide-treated nets for night-time prevention of mosquito bites; for pregnant women in highly endemic areas, preventive doses of sulfadoxine-pyrimethamine (IPT/SP) to periodically clear the placenta of parasites; indoor residual spraying to kill mosquitoes that rest on the walls and roofs of houses.
"Drug resistance to commonly used antimalarial drugs has spread very rapidly. In order to avoid this for artemisinins, they should be used in combination as ACTs, and artemisinin monotherapy (use of one artemisinin drug versus the more effective combination pill) should not be used. The less effective single-drug treatment increases the chance for parasites to evolve and become resistant to the medicine. Intensive monitoring of drug potency is essential to protect against the spread of resistant malaria strains to other parts of the world," the apex health body states.
WHO recommends continuous monitoring and is assisting countries as they work to strengthen drug observation efforts.
Akhimein, said the burden of the disease in the country is worrisome, as government has not taken the bull by the horn. He said: "If we had strictly adhered to the Roll Back Malaria policy and the National Drug Policy, we could have succeeded to large extend in reducing the burden of the disease.
"Right now, we have lost focus. We have seen a lot of policy shift without the resultant outcome. We are simply thronging ahead as if nothing is happening. For instance,
"Frankly speaking I think we should refocus and direct most of the resources to the preventive aspects of the programme. We have concentrated so much on the curative to the detriment of the preventive programme. We should deploy most of our arsenal on the vector. We should open the gutters, ensure healthy environmental".
But Sofola insisted that government intervention programme has been successfully as the burden of the disease has reduced from 36 per 1000 people in 2007 to 23 per 1000 people in 2008. We are increasing the level of coverage; within the next decade we should have reduced the mortality due to malaria substantially.
She said part of the strategic plan of the ministry is to ensure that treatment is offered free to all Nigerians in all the public hospitals.
But experts insist that the incidence of malaria is still high in the country as the disease is responsible for 30 percent of childhood mortality and 11percent of maternal mortality.
" It reduces Nigeria’s GDP by one per cent and is the commonest cause of absenteeism from schools, offices, farms and markets," UNICEF stated in a report to mark this year’s World malaria Day.
"Nigeria has good institutional arrangements under the aegis of the Roll Back Malaria initiative to reduce the disease. However, insecticide-treated nets use, which is the most effective way of preventing malaria, is still very low." the report said.
Nationally, only two per cent of children under five years and pregnant women sleep under insecticide-treated nets according to UNICEF.
Malaria control is now a major global development priority and is critical for achieving the Millennium Development Goals in Africa. Increased global awareness about malaria has contributed to a significant rise in available resources over recent years, thanks to the Global Fund to Fight AIDS, TB and Malaria, the US President’s Malaria Initiative, the World Bank, and others.
Malaria imposes substantial costs to both individuals and governments. Costs to individuals and their families include: purchase of drugs for treating malaria at home; expenses for travel to, and treatment at, dispensaries and clinics; lost days of work; absence from school; expenses for preventive measures; expenses for burial in case of deaths.
Costs to governments include: maintenance of health facilities; purchase of drugs and supplies; public health interventions against malaria, such as insecticide spraying or distribution of insecticide-treated bed nets; lost days of work with resulting loss of income; and lost opportunities for joint economic ventures and tourism.
Such costs can add substantially to the economic burden of malaria on endemic countries and impede their economic growth. It has been estimated in a retrospective analysis that economic growth per year of countries with intensive malaria was 1.3 percent lower than that of countries without malaria
Progress has been made in combating malaria, particularly in Africa where the disease is most prevalent, but more must be done to address the global scourge, UNICEF said.
"We are, for the first time in history, poised to make malaria a rare cause of death and disability," said Ann M. Veneman, UNICEF Executive Director.
"The report shows that endemic African countries received enough nets during 2004-2008 to cover more than 40 per cent of their at-risk populations."
Data presented in the ‘Malaria and Children, Progress in intervention Coverage’ report, a joint effort with the Roll Back Malaria (RBM) Partnership and the Global Fund to Fight AIDS, Tuberculosis and Malaria, show major signs of progress across Africa in the fight against malaria, particularly in the increase in distribution of insecticide-treated nets (ITNs). Since 2004 the number of Tins produced worldwide has more than tripled-from 30 million to 100 million in 2008.
"However every year, this disease still kills an estimated one million people, most of them children in Africa," said Veneman.
"Scaling-up effective interventions has led to declines in malaria cases and deaths at health facilities in many countries, including Eritrea, Rwanda, Zambia and Madagascar," said Veneman. "This has the added benefit of reducing the burden on over-stretched hospitals and clinics and having less absentees in the workplace and in school."
"The report shows financing is now available to purchase enough nets to put Africa well on the way to achieving universal coverage by 2010," said Veneman.
Osotimehin, said the major challenge is that of scaling up.
Osotimehimn said: "Though there has been considerable support in the past few years, areas of funding gap still exist. The total need is $1,273,954,749 for the scale up and a gap of $665,639,564 still exists. Other challenges include; institutional capacity building, mitigating drug and insecticide resistance and high cost of ACTs in the private sector. Local production of LLINs and ACTs."
He said appropriate policies, guidelines and framework are in place, but there is therefore great need to rapidly catch-up by scaling up all cost effective interventions nationally in all the 36 states and FCT. "This will lead to the reduction of malaria burden by half by 2010 and dove-tail to reaching the MDG target by 2015," Osotimehin said.
The Health Minister said though funds have been mobilized (internal and external), funding gap still exits, there is need to gradually withdraw the use of oral Artemisinin monotherapies and in its place to promote the use of Artemisinin combination therapies in order to delay development of resistance to ACTs.
He said: "AMFm is an innovative financing mechanism to expand access to affordable ACTs and a proposal drafting committee has been setup to enable us participate at the pilot phase.
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