A lack of data on drug safety in Australia’s Indigenous population risks the health of Indigenous people who are on therapeutic drugs from a younger age than the average population, according to experts published in the Medical Journal of Australia.
Dr Tilenka Thynne, from Flinders Medical Centre, and Dr Genevieve Gabb, from the Royal Adelaide Hospital, warned that drug safety in Indigenous Australians did not have a "robust evidence base" because in Australia "there are no specific reporting requirements for ethnic groups, including Aboriginals and Torres Strait Islanders".
"The potential for harm is real," Thynne and Gabb wrote.
The median age of the Indigenous population is just 21.8 years, compared with 37.6 years for non-Indigenous Australians.
"A younger group of people are exposed to drugs when starting cardiovascular screening and primary preventive treatment, leading to potentially longer cumulative lifetime exposure.
"Second, differences in drug response — efficacy and harm — exist in racially and ethnically distinct groups … it may be inappropriate to generalise what little information we do have with regard to efficacy and safety for the group as a whole," they wrote.
"Third, it is known that harm occurs … Indigenous Australians may be at higher risk of serious, and potentially fatal, statin-associated myotoxicity … Recently, three cases of ACE inhibitor-associated angioedema involving airway compromise in Aboriginal Australians were reported . A genetic predisposition to a specific adverse drug reaction in the Indigenous population has also been suggested."
Thynne and Gabb suggested that as it was impractical and expensive to test drugs in Indigenous populations before approval by the Therapeutic Goods Administration (TGA), "It is in the post-marketing space that a comprehensive and pro-active approach to addressing drug safety in Indigenous Australians is urgently needed."
"The assessment and management of potential adverse drug reactions should be part of any comprehensive health care program", they said, adding that "Aboriginal health care workers, like all health care professionals, need training in pharmacovigilance, drug safety and reporting of adverse events."