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:
Dear Mr. Hunt:
Medication Adverse Events
I refer to your letter dated 20 August 2018 (only released publicly this week) to Mrs. Lucy Wicks, the Chair of the Standing Committee on Petitions, regarding the recent petition ENO607.
Petition ENO607 presented a constructive way to facilitate greater consumer reporting. Your letter does not address these concerns or the concerns of consumers.
I am therefore writing to you to request a meeting on behalf of Australians for Safe Medicines (AFSM).
About Australians For Safe Medicines
AFSM is a consumer-led incorporated association of individuals that aims to improve medicine safety.
Our objectives are to promote the safe prescribing, dispensing, and consumption of prescription medicines in Australia including to:
- Educate consumers to make informed decisions on prescription medicines.
- Collect consumer stories and data for the purposes of advocating on behalf of the consumers.
- Engage with key stakeholders (such as the Government, regulatory authorities, media, health practitioners, and manufacturers) on medicine safety initiative and concerns.
- Any other activities consistent with the key objectives of promoting safe medicines.
In our short time of operation, we have made significant progress in our objectives.
We have been entrusted with close to 200 consumer stories. Some of these stories are on behalf of whole groups of 700 – 1000 people. We continue to collect more each week.
We also have a strong relationship with NPS Medicine Wise and are currently developing a consumer presentation about evaluating medicine safety.
We have also surveyed consumers on the Therapeutic Goods Administration’s (TGA’s) performance.
Government Stakeholder Concerns
Studies repeatedly show that adverse medication events are regularly in the top 4 causes of death and disability including in Australia.
The NSW Public Accounts Committee’s recent Health Services Inquiry heard testimony from Professor Ric Day, a clinical pharmacologist and recognized expert in pharmacotherapy and drug reactions and interactions that the cost of adverse medication events is very high and up to 40% of admissions.
A greater focus on the management of adverse events would have dramatic cost savings for the Australian taxpayer estimated at $12 billion in 2008 (with that number excluding mental health and aged care).
In your letter, you also state that there is no requirement to include warning statements about side effects on prescription medicine labels. Given that pharmaceutical companies have the skill, care and knowledge to do so, and doing so would result in significant cost savings to the Australian taxpayer, is your Government intending to amend the legislation? If not, why?
Regulator Stakeholder Concerns
Firstly, we acknowledge the efforts of the Therapeutic Goods Administration (TGA) as outlined in your letter. However, these actions do not address our concerns.
Our concerns are that the regulatory system is failing to engage effectively with the consumer, in circumstances where the Quality Use of Medicines (QUM) strategy identifies the consumer as paramount to its objectives.
Our survey of consumers shows that:
- 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 about warnings if they were only put on new medicines (i.e not existing ones).
- 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.
This suggests to us that key aspects of the Regulator’s strategy are failing. Specifically:
- Adverse event reports are a key component of the TGA’s strategy, yet consumers do not know how to report incidents, leading to only 4% being reported by consumers.
- The prescribing doctor is not consistently warning consumers of the risk of serious adverse events.
- Community pharmacists are not routinely providing the Consumer Medicine Information sheets.
- Consumers are NOT being contacted by the TGA after making reports. Extensive examples can be provided.
One of the overarching reasons that the strategy is failing, in our opinion, is that communication is not happening with the consumer and that the Government and Regulator should be doing more to facilitate this conversation.
At the time we surveyed consumers we also obtained a substantial amount of data that suggests a systemic complacency in relation to adverse medicine events with the TGA, The Coroner’s Courts, The HCCC/APHRA, and healthcare practitioners. Detailed examples of these failures can be provided.
Another recurring theme was the consumer perception that the Regulator is captured, and had an overall reluctance to place boxed warnings on existing medicines. For example, the TGA follows the FDA in licensing medicines, but then does not follow them on product information or public health advisories. Extensive examples can be provided of medicines that carry no warnings here in stark contrast to the USA where they have carried them for an extended period of time.
This is particularly relevant to the current consultation by the TGA into boxed warnings that are not proposing to place on existing medicines. This does nothing to address the existing risk for which Australian taxpayers are paying the price.
Consumer Stakeholder Concerns
The QUM strategy requires the individual to be considered, and this is especially important given that as Glaxosmithkline has stated:
"The vast majority of drugs - more than 90 percent - only work in 30 or 50 percent of the people," Dr. Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 percent of people. Drugs out there on the market work, but they don't work in everybody."
Consumers tell us they want informed consent prior to taking the medicine, and sufficient information to assess how they are going on a medicine, and that the current practices do not meet these needs.
We have raised some significant consumer concerns with you and I would appreciate a detailed response.
Also, as the custodian of the Australian health system, we also request you meet with individuals (or their loved ones) who have been permanently harmed as a result of poor prescribing practices, not only so that they can be heard, but to hear the simple changes that would have prevented that harm, and could result in dramatic cost savings to the Australian taxpayer.
I look forward to your response.