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Govt to monitor safety of Aids drugs

9 September 2004

Government has opened a new pharmacovigilance centre to monitor the safety of antiretrovirals and other medicines used for the treatment of HIV and AIDS.

Pharmacovigilance is an activity concerned with the detection, assessment, understanding and prevention of adverse reaction to various medicines.

The main objective of any pharmacovigilance programme is to improve the safe and rational use of medicines leading to improved patient care and public health.

The centre is housed at the Medical University of Southern Africa in GaRankuwa outside Pretoria.

Health Minister Manto Tshabalala-Msimang said the centre will focus on the use of ARVs among adults while working together with a similar institution in Bloemfontein that monitors the use of the same drugs among children and pregnant women.

"The risk and toxicity profile of antiretrovirals need to be understood in the South African settings and the complexities associated with various regimen should be continually assessed and managed appropriately and responsibly.

"As South Africans, the questions we ask in relation to HIV and AIDS treatment globally are genuine enquiries so that we can develop policies that are relevant to our country," she said.

The centre will specifically determine the burden of drug-related morbidity and mortality in patients with HIV and AIDS and develop measures to minimise negative impacts.

It will also develop systems to assess the risks and benefits of treatments commonly used in patients with HIV, STIs and TB.

"The programme will also establish an early warning system for resistance to antimicrobials commonly used in HIV including, but not limited to antiretrovirals," said the minister.

It will also be studying complementary and traditional medicines.

The minister also said the safety profiles of certain medicines were better understood than others because of historical uses, experiences in clinical setting and evidence.

"For maximum therapeutic benefit, information about safety must be collected in real life among larger populations because of limitations of data generated from clinical trials.

"Investigation and collection of data on adverse drug reactions remain one of the biggest challenges facing most developing countries," she said.

The centre is expected to be fully operational by October. A similar centre will be opened in Bloemfontein, with operational costs for both estimated at R7-million.

A fully operational pharmacovigilance centre is also housed at the University of Cape Town and monitors the safety of all medicines registered in the country.

Source: BuaNews

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