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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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Timely Intervention

In the early 1990s, the Chinese Academy of Military Medical Services (AMMS) developed a new generation antimalarial combination therapy called ARCO®. The AMMS combined two independently developed antimalarial drugs—artemisinin and naphthoquine—which were found to be safe and able to clear parasites from the human blood streams. The independently developed drugs had good efficacy profiles when they were administered as monotherapies.

As in other countries, the Tanzanian Ministry of Health and Social Welfare was convinced by the safety and efficacy profile of ARCO and therefore introduced the drug into the health system. The decision to do so was based on the safety studies done elsewhere in Asia and Africa where the safety profile was acceptably good.

Early studies carried out in clinical sites within and outside China—in Papua, Indonesia, Nigeria, Uganda, Ivory Coast, Benin and Myanmar—have all pointed to a "glossy" profile of the drug.

Collectively, ARCO was reported to be able to rapidly clear parasites and delay the development of malaria parasite resistance to the drug. It is given as a single dose daily instead of three daily doses or three twice daily doses. The simplified dosage, therefore, provides more chances for high adherence levels.

However, after the drug was introduced in Tanzania's public health system, several adverse events were reported. The most adverse events were headache, nausea, vomiting, dizziness and abdominal pain. Faraja Robert, a mother of three living in Dar es Salaam city, recalls having a terrible headache and dizziness after taking an antimalarial drug a few years ago.

“I don't remember the brand of the medication, but what I remember today is the terrible headache and dizziness that I had experienced,” she says. Malaria is still responsible for the majority of deaths reported in Tanzania. The disease kills on average 164 Tanzanians every day. Out of those deaths, more than 80 per cent are children who have not celebrated their fifth birthday.

Using its post marketing surveillance mechanism, the Tanzania Food and Drugs Authority (TFDA) decided to ban the use of ARCO® for safety concerns that were reported.

A press release issued quite recently, withdrew the registration of ARCO and its use from the health system, stating that it was meant to align with the 2013 changes of the malaria
treatment policy.

“The Authority wishes to inform the public that through its surveillance system, it has found that there are medicines in the market that do not meet the quality standards and that they are not suitable for human consumption,” the statement reads. “Subsequently, the Authority has deregistered five human medicines,” the statement elaborates.

Other deregistered human medicines include Sulphadoxine and Pyrimethamine; Amodiaquine, Phenylpropanol amine used to manage hemorrhagic stroke; injectable Chloramphenicol sodium succinate, and Ketoconazole used for treating fungus.

When contacted for details, the TFDA acting Public Relations and Communication Manager Gaudensia Simwanza says the Authority directs health service providers to stop administering deregistered medicines to patients.

The regulatory body wanted to be sure the reported complaints were investigated and whether they were resulting from ARCO drugs that were ordered from the Chinese Kunming Pharmaceutical Corporation.

The mission of TFDA is to be the leading African regulatory authority in ensuring safe, quality and effective food, medicines, cosmetics and medical devices for all.

It was understandable why TFDA had to pull the drug out of the market despite the efficacy profile of ARCO and its preference for use in the treatment of malaria.

Dr. Seif Shekalaghe of Ifakara Health Institute (IHI) says “ARCO is a good drug but it has its own challenges with regards to safety issues.

He said they were currently conducting a study to investigate the safety profile of ARCO and to find out whether there were any adverse events that were missed during the early phases”

The reasons, he says, include inconsistency in the evaluation schedules of laboratory information between the studies and also there was no standardized methodology of studies included in the pooled analysis and extrapolated in different population.

Because the methodology of clinical and/or therapeutic assessment had not been prospectively standardized prior to the conduct of the studies, there existed substantial inter-study differences in defining, assessing, reporting, and classifying efficacy and adverse events. However, all studies were conducted in accordance with the World Health Organization (WHO) guidelines for antimalarial drug efficacy assessment.

Applying the post-market evaluation framework provided by the INDEPTH Effectiveness and Safety Studies of Anti-malarial Drugs in Africa (INESS), scientists at the IHI's Bagamoyo branch decided to compare the safety profile and the tolerability of different ACTs to determine if there were any missed safety issues during the conduct of phases I to III clinical trials.

“In this proposed study, we evaluated the safety and tolerability of administration of ARCO to adult and children patients with uncomplicated malaria,”

Dr.Shekalaghe who is one of the investigators elaborates and said the study started in September 2013 and was concluded in February 2014.“The final results have not been announced yet,” he adds.

By MbarwaKivuyo, Dar es Salaam

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