Call for better consumer warnings

An MP has argued for improved consumer warnings in CMIs following a young man’s death after taking multiple prescribed medicines

Dr Anne Aly, Member for Cowan in WA, has called for changes to CMIs in Australia following the death of 22-year-old Isaac Reis in August 2019 after taking seven different medications.

According to the ABC, Isaac was on an antipsychotic, two antidepressants, an antihypertensive, an anticonvulsant, a benzodiazepine and an opioid at the same time.

“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,” Dr Aly said in Parliament last week.

“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.”

His death is currently being investigated by the Queensland Coroners Court.

Isaac’s father, Paul Reis told the ABC that his doctors and pharmacist failed to warn him of the deadly risks of taking so many prescription drugs.

Mr Reis, along with advocate Patrick O’Connor, has been lobbying the government improved consumer warnings in CMIs in Australia.

The family believe a centralised real-time script monitoring system and better consumer medication warnings might have saved their son.

Following Isaac’s death, they lodged a complaint with the QLD Health Ombudsman about the prescribing of high-risk medications to Isaac by his GP.

In response, the Medical Board of Australia imposed a number of conditions on the GP’s registration that include undergoing training on the prescribing of opiates and benzodiazepines, the management of patients seeking or requiring high levels of pain medication, and effective patient medical record keeping.

“We urge others who have been prescribed opioids and benzodiazepines, to discuss the full risks of these medications with your GP or pharmacist. We do not want others to suffer the same fate as Isaac,” Mr Reis recently wrote on Facebook.

However advocates believes more changes need to be made.

“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,” said Dr Aly.

“Experts have warned that there are likely to be more deaths like Isaac’s until there are improved consumer warnings in CMIs in Australia.”

The Department of Health added boxed warning to opioids in 2020, and the TGA recently said: “We will work with sponsors to ensure that safety information, including the relevant warnings, is prominently displayed in the CMI to ensure consistency of language and information across all classes of prescription opioids”.

However Dr Aly pointed out that such warnings have not been included in the CMIs of other medications that opioids combine with to cause death.

TGA head Professor John Skerritt last year told Mr O’Connor, who has been advocating on behalf of the Reis family, that the responsibility for CMIs lies with pharmaceutical companies, and that the TGA does not have a role approving CMIs.

He maintained that CMIs usually advise the importance of having further discussions with the prescribing doctor or the dispensing pharmacist, particularly if the consumer has any concerns or questions about using the medicine.

“While PI and CMI are important tools to assist prescribers and consumers to be aware of potential risks, they are not intended to be a substitute for individualised health professional advice or informed consent,” Professor Skerritt said.

Dr Aly took issue with the fact that there is no Australian government department officially regulating CMIs.

“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,” she said in Parliament.

“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.

“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.”

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1 Comment

  1. Peter Allen

    Not only but also…. A list of “extremely uncommon” adverse reactions to Covid-19 vaccines would “scare the shit out of anyone.”
    Less uncommon than “they” would have us believed. Because anyone who has waded through filling in a “Blue form” wouldn’t bother the trouble next time when such a report would likely be brushed off as “not causally related.”
    Neurological especially.

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