Sub-standard anti-malarial medicines flood Ghanaian market

Accra, Nov. 11, GNA - A member of the World Health Organization (WHO) Expert Committee on Quality Assurance of Medicines, on Wednesday said Ghana was inundated with substandard and counterfeit anti-malarial medicines due to poor regulatory standards in local drug manufacturing and importation. Professor Ivan Addae-Mensah said studies by WHO Essential Drugs and Medicines Policy Division on the quality of anti-malarial drugs in some African countries including Ghana revealed several sub-therapeutic products in the drug manufacture and distribution chains.

"The case of Ghana is particularly disturbing. We had the highest failure rate in content and a 75 per cent failure rate for dissolution," he said.

"In effect patients treated with some of these drugs were being significantly under-dosed and, with that under-dosage, only 25 per cent of the products tested were releasing adequate amounts for activity during treatment," Prof Addae-Mensah stated at a public lecture organized by the Ghana Academy of Arts and Sciences (GAAS) in Accra.

The lecture was on theme: "The Threat of Counterfeit and Sub-standard Drugs to Healthcare Delivery in Developing Countries." It was chaired by Prof. Reginald Fraser Amonoo, GAAS President, and attended by academia, students, health professionals and media practitioners.

He said the study revealed several significant substandard products ranging from the manufacturer through the distribution chain to the end-user.

"Ingredient content failures ranged from 20 per cent to 67 per cent for chloroquine tablets and five to 38 per cent for sulphadoxine/pyrimethamine tablets.

"Dissolution failures ranged from five to 29 per cent for chloroquine tablets to 75 to 100 per cent for sulphadoxine/pyrimethamine tablets." Prof. Addae-Mensah, a former Vice-Chancellor of the University of Ghana, said more alarming was the fact that within the distribution chain, failure rate at district hospitals, where many patients received their drugs after seeing a doctor, was the highest for both chloroquine syrup (27.2 per cent) and chloroquine tablets (70 per cent).

He said they were followed by district medical stores with 58.3 per cent; shops and vendors (50 per cent), teaching hospitals (44 per cent for tablets and zero per cent for syrup).

Prof. Addae-Mensah said even for drugs that passed the test, it was detected that the manufacturers seemed to be restricting themselves to the barest minimum possible quantity of active ingredient per tablet. "Operating around such lower limits of pharmacopoeial requirements could have potential adverse consequences for patients. In advanced countries where regulatory measures are stringently enforced, manufacturers normally operate at worst around the median value of pharmacopoeial specifications," he said.

Prof. Addae-Mensah said even though most malaria endemic countries had now adopted artemisinin-based combination therapies as first-line treatment of falciparum malaria in place of chloroquine, "the new artemisinin based drugs are not doing better".

Prof. Addae-Mensah, who is also a member of the Expert Scientific Advisory Committee of the European Union Consortium for Development of new Anti-malarial Drugs, said these new anti-malarial drugs had also become the target of a very sophisticated and highly profitable counterfeit drug trade. He said the increasing prevalence of fake artemisinin products on the continent was one of the challenges that needed to be overcome in order to maximize the public health benefits of artemisinin-based combination therapies.

Prof. Addae-Mensah suggested a regular screening exercise to ensure the supply and distribution of quality drugs for the treatment of malaria. "National drug regulatory authorities, especially in developing countries, where sophisticated methods may be lacking, need rapid, inexpensive but reliable analytical techniques to screen such drugs to be able to determine their quality before being authorized for use," he said. Some of the participants who were moved by the revelation called for stiffer punishment for counterfeit drug peddlers, manufacturers and distributors to serve as deterrent.