Alert over low grade malaria drugs

by Gatonye Gathura, Daily Nation

Kenya is now a free-for-all market for malaria drugs with more than 113 brands from 20 countries being sold. Of these, more than half are not registered, a similar number are of poor quality and most are not recommended in the country, according to the Ministry of Health. The ministry blames local drug manufacturers and those who import the medicines from India as the most notorious in flouting national malaria guidelines as they flood the market with inappropriate and low quality drugs, which include chroloquine and SPs (sulphadoxine-pyrimethamine) whose use was discontinued years ago. The revelations come at a time when the country is experiencing a near total breakdown in the anti-malarials supply chain. Two weeks ago, the Nation reported that the country faced an imminent stockout of first line malaria medicines, AL or artemether-lumefantrine. While admitting serious delivery problems, the acting director of Public Health and Sanitation, Dr Swaleh Sharif, said there were enough drugs until expected imports arrive. The first consignment of about 400,000 doses of the expected eight million doses of AL arrived last week, but these are hardly enough for a month.

Corrupt officials An unpublished report, which Nation has a copy of, confirms what has always been known to be the biggest obstacle to a successful anti-malaria campaign — well-entrenched cartels of drug manufacturers and distributors working in cahoots with corrupt Health ministry officials to supply their own drugs. The report, Antimalarial Medicines in Kenya: Availability, Quality and Registration Status, was compiled by Government officials and University of Nairobi and the WHO consultants last November. “Of the medicines on the market, almost half have not been registered with the Pharmacy and the Poisons Board and of the unregistered products, the majority were from Kenya and India,” it says. Of the 40 different formulations in the country, only 11 are recommended in national malaria treatment guidelines with almost half of them being supplied by 14 local manufacturers. While the study found that 16 per cent of antimalarials in the market were substandard, some drugs such as amodiaquine and SPs, the most popular, had a failure rate of 45 per cent and 30 per cent respectively. Amodiaquine should have been withdrawn from public hospitals in 2006 and SPs gradually discontinued and replaced with the more effective AL.

Well stocked Another study carried out by the Government and researchers from the universities of Boston and Oxford says it is puzzling that health facilities are well stocked with non-recommended antimalarials such as amodiaquine. In some places where AL was in stock, it was rarely used. But it is quinine that proves how callous these cartels are. “Some samples of quinine failed on the content of active ingredient. This is of great concern because quinine is the first-line treatment for severe malaria and could easily lead to treatment failure and resistance,” says the ministry study. Five samples Of five samples that failed tests at the National Quality Control Laboratory on content of active ingredient, four were made locally while one was from India. The study shows that monotherapies and other formulations that should not be on the shelves are actually outperforming the recommended AL treatments. AL tablets were found in only 33 per cent of health facilities. Two years ago, WHO wrote to several companies across the world, some in Kenya, demanding that they stop production of monotheraphy antimalarials. Some have complied, but in Kenya, the practice continues with the tacit approval of the Government or its agents. WHO laments that only 40 out of the 74 global manufacturers of monotherapies have agreed to stop production. What is particularly galling is that of the 42 countries that still allow companies to market monotherapies, 18 are in sub-Saharan Africa, the region hardest hit by malaria.

Widely sold And despite Medical Services minister Prof Anyang’ Nyong’o’s assurance that there are no monotherapies on the market, the reality is different. In April, the Pharmacy and Poisons Board wrote to manufacturers and distributors giving them up to September to stop manufacturing, importing and distributing monotheraphy drugs, but these medicines are still widely sold. The study strongly recommends that the Pharmacy and Poisons Board enforces the withdrawal from the market of all non-recommended malaria medicines. However, manufacturing and distribution cartels, some of who are members of the enforcing agency, are likely to offer stiff resistance to this.