New Report Sparks Queries Over Malaria Drugs

A new medical survey has come up with disturbing a revelation; more than a third of malaria medicines on the market are fake, dealing a serious blow to international efforts to roll back the killer disease.

These findings are a wake-up call and demand a series of interventions to better define and eliminate both criminal production and poor manufacturing of antimalarial drugs

The study carried out by the Fogarty International Centre at the US National Institute of Health (NIH) in Bethesda, Maryland, states that more than a third of malaria drugs analysed by scientists in Africa were below standard.

“The economic incentives for criminals of drug falsification surpass the risks involved in their production and sale,” the authors wrote in the article published in the Lancet Infectious Diseases Journal.

Dr Corine Karema, the Head of the Malaria and Other Parasitic Diseases Division at the Rwanda Biomedical Centre (RBC), told The New Times that this must be the first big study on malaria drug quality outside India and China.

“These results show that it is time for Africans to wake up and establish pharmaceutical regulations. It is a call for countries to improve regulations in malaria commodities procurement and supply of drugs, diagnostic and also surveillance of all malaria control interventions, including quality and efficacy of products used,” she told The New Times yesterday.

The study collected data in 21 sub-sahara countries. The results, Dr Karema said, are worrying as with these data “we see how malaria cases have been missed to be treated” and hence could have significantly avoided malaria morbidity and mortality.

The researchers found that in 21 sub-Saharan countries, 20 percent of more than 2,500 samples tested in six drug classes turned out to be falsified, and 35 percent were below pharmaceutical norms.

“These findings are a wake-up call and demand a series of interventions to better define and eliminate both criminal production and poor manufacturing of antimalarial drugs,” said Joel Breman of the Fogarty International Centre.

Sub-standard medications are a major problem in the fight against malaria, a disease which killed 655,000 people in 2010, according to the UN’s World Health Organisation (WHO).

In Rwanda, the recent scaling up of interventions has made significant reductions in morbidity, by 87 percent, from 1,669,614 malaria cases in 2005 to 212,200 cases in 2011, and reduced mortality, by 76 percent, from 1,582 deaths in 2005 to 380 in 2011.

Dr Karema, however, said the drug samples cited in the US survey are not used in Rwanda.

“The government has put in place strategies and strong mechanism to prevent entering of fake drugs with coordinated supply of antimalarial drugs from the MPDD to health centres through district pharmacies,” she said.

Rwanda treatment guidelines require laboratory confirmation of malaria before any treatment and at all levels of health care, including community level where community health workers use rapid diagnostic test to test malaria and treat children under five.This also prevents spread of drug resistance.

For each entry of drugs in the country, it requires a visa from RBS and the Ministry of Health (MoH) and all documents are screened and a quality control certificate is required. Only authorised pharmacies are allowed to supply drugs.

Karema went on to say that, specifically for malaria drugs, the Malaria Division carry out monitoring of the drugs in two ways: annual monitoring of the efficacy of antimalarial drugs in children under five using the WHO protocol, and monitoring the quality of antimalarial drugs.

“We follow patients up to 28 days, Dr Karema said, adding, “today the efficacy of Coartem is 98%”.

Last year, more than 400 samples of drugs, including Coartem, quinine tablets, and quinine injectable were collected in 42 sites to test their efficacy, according to information from the Rwanda Biomedical Centre.

“Up to today, antimalarial drugs in Rwanda meet the quality requirements but there is need for patients to help the MoH to continue to monitor and ensure better quality of drugs,” Dr Karema added.

She appealed to patients to comply with malaria treatment guidelines, respect dosage and prescription and be tested and confirmed for malaria before any treatment, to help the country to prevent resistance to antimalarial drugs.

Many of the fake or poorly manufactured drugs are artemisin derivatives, the study said.

This is a special worry because artemisinins are the frontline treatment for malaria, replacing drugs to which the malaria parasite has become resistant.

The study says there are many causes for the problem, ranging from widespread self-prescription of drugs, to shoddy controls to monitor drug quality and prosecute counterfeiters.

“Poor-quality antimalarial drugs are very likely to jeopardise the unprecedented progress and investments in control and elimination of malaria made in the past decade,” said Breman.

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BY JAMES TASAMBA, 23 MAY 2012