Federal Parliament - Prescription medicines

June 21, 2021

Dr ALYIsaac Reis was just 22 years old when he died in August 2019 after taking seven different medications. They were all prescribed by his usual doctors and all dispensed by his usual pharmacist. None of the consumer warnings for any of the medications prescribed to him warned Isaac of the risk of death. Prescribed medications are one of the leading causes of accidental death in Australia each year. Each death is made even more tragic because it is avoidable.

Consumer medicine information, or CMI, is the leaflet you get when you have a prescribed medication. It is often provided to you by your pharmacist. It should detail the safe and effective use of the prescription medicine. Each CMI must conform to schedule 12 of the Therapeutic Goods Regulations, which requires that it contain information on interactions with other medicines as well as alcohol or any adverse side effects. The TGA acknowledged to the Australian Human Rights Commission this year that they have never regulated consumer medicine information in Australia since they began in 1999. Basically that means that there is no Australian government department regulating consumer medicine information.

I have some examples of consumer medicine information. Dexamfetamine is a schedule 8 drug for ADHD. The CMI for dexamfetamine contains no mention of addiction or death, which can occur even when taken as prescribed. Dexamfetamine is used by around 25,000 Western Australians, including 9,000 children. As to endone, which is a kind of opioid, the Department of Health added the black-boxed warning to opioids in 2020; however, they did not include it in any other medication that opioids combine with to cause death.

Since 1999, the CMI for valium has remained unchanged, despite 10,000 deaths linked to benzodiazepines. No CMI has ever mentioned any risk of death. Valium is also regulated by the US FDA, and the US medication guide actually does explicitly state a warning of death. But that's not in the Australian CMI.

The Australian Human Rights Commission complaint about this details how pharmaceutical companies have excluded life-threatening side effects from hundreds of Australian CMIs for over 20 years. Those risks are known to the TGA. They're included in comparable US consumer warnings, as I mentioned as to valium, which are also monitored by the US FDA.

Isaac Reis did not die because he overdosed. He didn't die because he failed to follow his doctor's orders; he died because he did. Experts have warned that there are likely to be more deaths like Isaac's until there are improved consumer warnings in CMIs in Australia. I have to thank my friends Aurelio Costarella and Patrick O'Connor for valiantly pursuing this cause and bringing it to my attention.

Thirty-three thousand veterans are taking five or more medications, and four of the most commonly prescribed medications, including the opioids, benzodiazepines and antidepressants that I have just mentioned here, that have no warning of death or addiction in their consumer medicine information. In 2020, an independent report was authored by Patrick O'Connor, titled Prescribed Deaths, and it details how medically-acknowledged risks and side effects have not been included in these CMIs. The head of the TGA has rejected two formal requests to have these kinds of side effects added to CMIs. It is a very simple fix that could save thousands of lives.

I intend to write to the minister for health and seek a meeting with him about this important issue. It is my strong belief that we here must do all that we can to help stop these preventable deaths by ensuring that consumer medicine information in Australia is reviewed and regulated by the TGA to include explicit warnings about death and addiction.