BY DESMOND CHINGARANDE in Mexico
Experts attending the 10th International Aids Society (IAS) 2019 conference have discouraged the continued use of expired anti-retro-viral (ARV) drugs on people living with HIV and Aids.
They said increasing the shelf life of the drugs after their expiry will be a disaster in fighting the pandemic.
Zimbabwe is one of the countries that have continuously extending shelf life of expired ARV drugs with HIV and Aids activists complaining over the matter saying the government was putting their lives at risk.
IAS 2019 president Anton Pozniack told NewsDay in Mexico City that extending the shelf life of ARVs for more than a year or more without the involvement of the manufacturer could put the lives of people living with HIV at risk.
He said extensions were based on the assumption that all lots have been stored according to current good manufacturing practices that include requirements for
environmentally controlled storage conditions and have been retested annually or semi-annually.
“However, no product will be extended beyond 10 years from the original manufacturer’s expiration date,” Pozniack said.
Nyaradzo Mgodi of the University of Zimbabwe College of Health Sciences, who is attending the conference, added that the extension of the shelf life must be
done after full assessment and lab test analysis.
“Shelf life is extended after a full assessment of the initial dossier info plus lab analysis. The request (submitted to the Medicines Control Authority of
Zimbabwe (MCAZ) by the manufacturers via NatPharm, just like what happens with some of our IND studies) is taken to the registration committee who makes
recommendations for further investigation and testing. They consider stability data submitted initially and subsequently,” Mgodi said.
“They also put into consideration the shelf life of the same product in other countries. For example, the recent exercise where ARVs were initially given two
years at registration due to available data, but subsequent ongoing stability tests went on to justify a shelf-life of three years, tests on degradation
products and related substances are done to check for impurities.”
Several activists have questioned the move to continuously give HIV positive patients expired drugs.
HIV activist Tendai Westerhof said there was need for a policy to protect consumers from being prescribed expired drugs by both the MCAZ and the Health and Child Care ministry, saying the issue could be a gross violation to quality health.
“There are efficacy issues and to me it is a gross human violation to quality health. We are calling for a research on the effects of using expired ARV on human,” Westerhof said.
According the international standard of extending drug shelf life, the drugs are given a maximum of up to two years for the first time after a lot of testing.