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TIPS ON MALARIA

  • HOW CAN MOSQUITOES BE CONTROLLED?

    Mosquitoes around the home can be reduced significantly by minimizing the amount of standing water available for mosquito breeding. Residents are urged to reduce standing water around the home in a variety of ways.

  • HOW CAN I PROTECT MYSELF FROM MOSQUITO-BORN DISEASES?

    The best way is to avoid being bitten by mosquitoes.This can be accomplished using personal protecting  while outdoors when mosquitoes are present. Treated bed nets should be used sleeping. Mosquito repellent should be used when outdoor.

  • WHO ARE AT RISK?


    Nearly half of the world’s population is at risk of getting malaria. Pregnant women are particularly at risk of malaria. Children under 5 years are at high risk of malaria.
     

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INESS A lasting legacy for better health

There is a growing need for rational approaches for countries across Africa to decide on how to prioritize, choose and integrate new and different anti-malarial drugs into their health delivery systems. This is due to the increasing numbers of new artemis inin-based combination therapies and brands flooding the market.

Data is for instance needed on how these new drugs work in patients, communities and the health systems for effective policy decisions to be made on drugs based on whether they are effective, ineffective, efficacious or non-efficacious.

There have been arguments that weaknesses in health systems are the primary cause of the erosion of efficacy in drug treatments and other health interventions. It is emerging that the losses in drug efficacy are due to system problems affecting health outcomes.

These systems issues are related to factors such as accessibility, affordability, acceptability, diagnostics, provider compliance and patient adherence to taking drug.

It is this gap that the Phase 4 INDEPTH Effectiveness and Safety Studies (INESS) project sought to bridge. The project, which took off in Ghana, Tanzania, Burkina Faso and Mozambique, in 2009, examined the accessibility, availability, acceptability, adherence and compliance of the prevailing health system to effectively deploy anti-malar ials based on pharmacovigilance issues and the efficacy of drugs.

Researchers and health workers in the four countries can now boast of a home-grown platform created to carry out future Phase 4 clinical trials into various drugs, vaccines and other products, which find their way into the African market. The INESS project is seen as the largest and first-ever Phase 4 structure on the continent.

Recently, Eurartesim, a branded drug, belonging to the dihydroartemisinin-piperaquine anti-malarial group, was tested on the platform between 2012 and 2014 to assess its safety to direct treatment policies.

The Missing Link
The missing piece in the development of new drugs is that they are not tested on large populations before being licensed for use. Phase 4 studies fill this gap because it allows new drugs to be tested on large populations to determine real-life events after licensure of drugs.

The INESS project therefore served as the platform to introduce a phase 4 structure to gather evidence that would be valuable for policies on anti-malarials like eurartisim and other products. Specifically, the researchers gathered data and practical evidence to ensure the effective treatment of malaria to allow policy decision to be based on the assessment of how well anti- malarial drugs are doing when administered in the general population after the drugs find their way into the open market.

The INESS project is part of plans to build strong health systems in Africa to minimize the time gap between licensing and adopting new anti-malarial drugs by making available an objective effectiveness and safety data to help inform global, regional and national policies and practices.

This is based on predictions that anti-malarials such as artemisinin-based-combination therapies (ACTs) are highly effective however when they are deployed in real life situation, then they become a systems issue.

Factors like the distribution of the drugs, adherence, provider behavior, accessibility and affordability among several others are said to contribute to making the drugs ineffective when used by the communities.
The INESS project also aims at enhancing the capacity of Africans to monitor local health systems in order to track the effectiveness of drugs in the system.

The project used the Health and Demographic Surveillance Sites (HDSS) in the four countries run by INDEPTH Network, an international organization.

For Dr Margaret Gyapong, Director of the Dodowa Health Research Centre (DHRC), which is located in the Shai-Osudoku district of the Greater Accra region, there is a lot to celebrate.

In an interview, she said this is the first time a study of this sort has been carried out at her centre and it has provided a learning opportunity for them as a research site to be able to recruit study participants, work on data entry, collect samples and interpret them as part of the study.

“So our capacity has been built in this area. The study has also exposed the centre a bit more on maintaining a safety platform and this has opened us up to any phase 4 study. It has to strictly monitor projects.

“We had support from INESS to build our laboratory. The study has also linked us up with a community including regulatory bodies like the Food and Drugs Authority (FDA),” she added.

Home grown solutions
Dr Alex Adjei, the Principal Investigator and Clinician who worked on the eurartesim drug trial at Dodowa, also confirmed that the “INESS platform is ready for any phase 4 study.

He said this is the first time a phase 4 study has been carried out in Africa, sponsored by an African institution and organized fully by African clinicians, health workers, pharmacists and others.

Dr Adjei said as a result of the INESS safety studies, they now have “the capacity to test vaccines. The men are there, the centres are there and the logistics are there. It is also going to help us make our own policy decisions. Here the Europeans are not going to tell us they did this study and these are what they found.”

He commented on the eurartesim drug trial and said: “We did this study in Africa by Africans so the findings that are going to come out will be a true reflection of what happens in real life settings. We can actually tell the whole world that this is what we did and these are the men we used. And this is our findings.”

Responding to a question that in carrying out the study on eurartesim, the African researchers had collaborated with the European regulatory bodies and therefore they could not be independent of their European partners, Dr Adjei said: “Yes, because the drug was produced by Sigma Tau, an Italian company.”

He said since the manufacturing of the drug by the Italian drug company was supervised by European regulators, they were also interested in the phase 4 findings and what the INESS platform was going to come out with because the drug company did not carry out a phase 4 trial on this drug.

According to Dr Adjei, there was no question about being controlled by the Europeans because everything was done independently by Africans and the Europeans could only be described as partners.

On his personal experiences in working on the platform, he said as a clinician: “I am not just a doctor to prescribe drugs. There is the need to follow up on patients to see if a patient is doing well, the effects of the drugs on the person and how the person is adhering to the instructions on the prescription. The patient must be made to come back to tell the story of his or her recovery or otherwise, for further evaluation to be carried out.”

As part of the INESS and eurartesim studies the researchers had to follow-up on patients after treatment to see how they are getting along after hospital visits for a more personalized care to make treatment effective.

Dr Kwaku Poku Asante, the Principal Investigator in the trial in the Kintampo Health Research Centre, also gave an account of his experiences.

“This is the first time we have established a platform for pharma-covigilance issues in typical rural areas and I am excited about how people embraced the study to establish the safety of drugs. Most of the time, when drugs get onto the market, we miss out on most of the information we can collect.”

He said the capacity of their staff has been built and a community made up of various stakeholders such as the FDA has been established and is now available to carry out other trials into various products and drugs, like anti-hypertensive and diabetes medications.

The Director of the Kintampo Health Research Centre, Dr Seth Owusu-Agyei, also added his views to the legacies left behind by the phase 4 platform saying: “We have not been looking at the effectiveness of drugs after it is found to cure people after registration and post licensure. So what INESS brings on board is some of the lessons of post-licensure of drugs.” He expressed concerns over funding issues, saying all support to “this study was external. The study had to rely on external funding to carry out the trials with the exception of the core funding from government for the Ghana Health Service staff.”

He said government must make available some seed money to help so that on a regular basis tests can be conducted on imported and locally manufactured drugs to assess their safety and efficacy to ensure that resources are not spent on drugs which are not working.

According to him, the gains from the phase 4 trials will not be limited to testing only anti-malaria drugs but all other drugs that are licensed, including the RTS,S vaccine, which is going through registration and licensure.

Dr. Esperanca Sevene, the Eurartesim Study Principal Investigator, at the Manhiça Health Research Centre, in Mozambique, also shared his views on working on the platform According to him, “ the INESS platform has established centres which are prepared with well trained researchers to carry out phase 4 studies in Africa, which can “answer research questions of specific interest for the African communities.”

He said his personal experiences in working on the INESS project is in connection with the stringent protocols they had to work under to meet the standards set in place by the European Medicines Agency (EMA) regulation, which has made their team well equipped to implement post-licensure studies.

Dr Abraham Oduro, Director of the Navrongo Health Research Centre, also touched on some legacies of the INESS project and said the base line has been built for phase 4 studies for centres with health and demographic surveillance sites, which measure and monitor health interventions and outcomes in communities.

He said some legacies can be seen in the confidence level of the African researchers who worked on the studies and also this has provided them with the credibility to undertake such studies.

He said it is not enough that drugs manufactured are efficacious when they get into the health system but it is equally important to assess the socio-cultural context within which drugs are deployed in terms of their effectiveness, affordability, accessibility, cost and adherence among others and this was what the INESS sought to do.

He explained that through the INESS project they have been able to study all these related socio- cultural issues that affect how drugs can impact on treatment and health outcomes.

Dr Oduro said the INESS project also brought in some substantial financial assistance which helped in improving existing infrastructure.

Dr Abdunoor Mulokozi, Clinical Epidemiologist and the Principal Investigator for the Tanzania INESS Platform, simply says it has been wonderful working on the platform.

He said it is crucial to assess any antimalarial for its effectiveness before it is deployed nation-wide and called for financial support to operate the platform.

Dr Mulokozi briefly touched on the eurartesim trial in Tanzania and said although there has not been any engagement with policy makers for the use of the drug in the health system
and its incorporation in the treatment policy, the results from their studies A study office in Tanzania would update policy implementation and added that the site is looking forward to evaluating the efficacy of other antimalarials in the pipeline.

He spoke on funding issues and said it was rather difficult for research sites to maintain the INESS platform without adequate support. “The INESS platform is a unique opportunity but it is rather difficult to maintain the INESS platform operationally through research financial support alone. To keep the infrastructures operating between the time of study phase-out and the application for the new product for the next evaluation, there should be some sort of government involvement.”

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