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Our Letter to Minister Hunt Regarding Petition ENO607

Petition ENO607 called on the Government to

"TGA should mandate all pharmaceutical companies to put clear warnings on the outside of the boxes of all dangerous medications. TGA should access denominator data, improve the quality of information reported via spontaneous reporting systems. The necessary and sufficient information required from the reporter, to assess a causal link between medicine and effect, should be requested in the user instructions on the TGA Blue cards. Blue cards should be given (with directions to equivalent online reporting) to every consumer at the point of drug sale and regularly to every patient in Australia."

Minister Hunt's response failed to identify ways to improve consumer reports and rather disturbingly stated that Australian legislation does not currently require medicines to have warnings on them. 

Given the cost to Australian taxpayers of medicine errors and the fact that pharmaceutical companies have the skills and knowledge to do so, and give warnings in other countries, we found this statement egregious. 

We, therefore, wrote to Minister Hunt requesting a meeting between him and consumers harmed by poor prescribing practices together with a detailed response to our concerns. 

Our full letter follows:

 

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Our Submission About Medicine Warnings

Thank you to everyone who responded to our survey about medicine warnings.


Here are the results:

  • 90% have been harmed by medicines due to lack of warnings.

  • 87% were not told that their medication could cause serious harm prior to taking it.

  • 11% were warned by their doctor and 3% by their pharmacist.

  • 67% were not given any product information.

  • 25% were given the leaflet in the box. 18% were given a print-out from the computer.

  • 88% thought warnings should be placed on both the box and the leaflet in the box.

  • 84% would be confused if warnings were only put on new medicines.

  • 96% want pharmacogenomic information included on the boxed warnings.

  • 73% did not know how to make a report to the Therapeutic Goods Administration.

  • 93% would be more likely to report an adverse event if the form was provided with the medicine.
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Why We Are Campaigning on Pharmacogenomics

There are many aspects to safe medicines.

Our current campaign focuses on petitioning the Australian Senate to do more to reduce unsafe medicines by introducing pharmacogenomics. 

Unsafe medicines are a leading cause of death and disability worldwide.

Current Australian prescribing guidelines are outdated as they do not consider the individual's response to medicines before prescribing them. 

Pharmacogenomics is the branch of medicine that predicts an individual's response to medicines. 

The introduction of pharmacogenomics in Australia lags behind the science and world’s best practice.

Our petition calls on the Australian Government to adopt world's best practice. 

We want to see a “no prescribing without pharmacogenomic testing” policy here in Australia. 

That’s why we think the Australian Government should be doing more and why we are asking you to stand with us by signing our petition.

Will you stand with us for safe medicines?
#mylifematters

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Read What The Experts Are Saying-

NSW Health Estimates: The Government's Response to Pharmacogenomics

The Public Accounts Committee Recommendations that clinical pharmacologist (specialists in drug prescribing and medication issues) be employed in each hospital district and pharmacogenomics is actively pursued and funded.

Ms. Dawn Walker (NSW Green's Senator) asked the Minister for Health, Brad Hazzard, questions regarding the employment of specialist clinical pharmacologist and the employment of pharmacogenomic testing. 

The questions and their answers are below. 

It appears to us that the Minister is being given grossly outdated or incorrect information. 

We have requested a meeting with him to ensure he is updated. We will keep you updated on whether the minister agrees to meet and ask for volunteers to meet with him. 

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Inquiry Into The Management of Healthcare Delivery in NSW

Last month (September 2018) the New South Wales Public Accounts Committee delivered its findings following its inquiry into the delivery of healthcare services.

The Committee heard harrowing confidential testimony and received submissions from health consumers who had been misdiagnosed and mistreated as mentally ill when in fact they were having an adverse drug reaction precisely explained by pharmacogenomics.

These consumer stories led The Committee to seek testimony from Professor Ric Day, an internationally recognized clinical pharmacologist and expert in pharmacotherapy, drug reactions, and interactions.

Following his testimony, The Committee made two key recommendations, to employ more specialists (clinical pharmacologists) to improve safe prescribing practices and adverse drug reactions and to actively pursue and fund pharmacogenomic testing for patients with a mental illness. 

Whilst these recommendations relate to mental health if implemented this is likely to have wide-ranging effects for not only those on mental health medicines but health consumers in general. The same principles apply and many adverse events mimic mental health conditions as the consumers testified.

But these are recommendations. The Government has six months to respond which means that we collectively have six months to lobby the NSW Government, and six months to use these recommendations.

You can read the full transcript of their report on medication management below.

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Pharmacogenomic Testing in Mental Health - Why Is It Not Used More?

By Associate Professor Leslie Sheffield

There are now several pathology companies providing genetic testing for how people react to drugs.

There is a lot of difference in the way individuals handle medication and this can now be tested by a method called pharmacogenomic testing.

This type of testing is now available through doctors, selected pharmacists and even online together with a nominated doctor. The costs of these tests continue to come down as technology advances.

Despite all of this many doctors do not support this type of testing and some obstruct patients who are wishing to get tested. Why is this so? I will try and give you a short explanation of why this is so.

Firstly let me introduce myself. My Name is Dr. Leslie Sheffield and I am a Consultant Physician and Clinical Geneticist. I have served over 30 years as a clinical geneticist providing public genetic counseling services in South Australia and Victoria. 

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