WHO not alarmed by ‘shoddy medicines’ report

THE World Health Organisation has launched an investigation into a study which claims that some WHO-approved medicines used to treat malaria and tuberculosis that were sampled in Nigeria and Ghana are of inferior quality.

Namibia also receives malaria and tuberculosis drugs through various donor programmes.The Namibian contacted Dr Magda Robalo, the WHO’s representative in Namibia, last week after the findings of Dr Roger Bate were published in the Washington Post. Bate tested 140 drugs from 37 pharmacies in Lagos and Accra and found that 7,7% of the tested drugs contained too little of the active pharmaceutical ingredient.Robalo yesterday said that Namibia was not part of Bate’s project and that none of the alleged inferior drugs were found here. She also said the WHO has launched its own investigation to ascertain what could potentially have caused the ‘failures reported in the [Bate’s] articles’.By yesterday, WHO investigators could not confirm the inferior quality of the medicines as reported in the study, said Dr Lembit Rägo, coordinator of quality assurance and safety of the WHO in Switzerland.The WHO said they were investigating whether the alleged failures could have been caused by manufacturing problems, degradation during transportation and/or storage, laboratory errors and potential falsification. The WHO has also looked at the medicines specified in Bate’s paper, which includes inspection of manufacturers, retesting of retention samples and checking results of independent laboratory quality testing.’Additional independent sampling and testing is planned to evaluate the quality of pre-qualified antimalarials supplied by the Affordable Medicines Facility – malaria (AMFm) project in order to verify the published findings,’ Robalo said.She said ‘a lot of additional details are still required for a qualified scientific judgment of the findings presented in the publication. These details are currently missing from the published papers.’Currently the WHO’s position is that the ‘reported data about inferior quality of the medicines are not confirmed and robust enough to justify actions against antimalarials mentioned in the paper nor the release of any regulatory warning against inferior quality of these pre-qualified medicines is needed’, Robalo said.She said the WHO supports countries, including Namibia, to strengthen their capacity to provide ‘safe, efficacious, affordable and quality-assured medicines to treat and/or prevent diseases through capacity building and technical assistance’. ‘The WHO Prequalification of Medicines Programme ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy,’ Robalo said.The Namibian was also assured by a source close to the Namibia Regulatory Medicines Council (NRMC) last week that Namibia has a ‘strict and rigorous’ system of ensuring that all medicines in the country meet international health standards and patients need not fear using products of poor quality.