I came upon this alarming document the other day.
AMA Submission to the Therapeutic Goods Administration – Proposed amendments to the Poisons Standard – March 2020
medicines.scheduling@health.gov.au
The AMA thanks the Therapeutic Goods Administration (TGA) for the opportunity to comment on the Proposed amendments to the Poisons standard consultation. The following feedback applies to the scheduling proposals referred to the Advisory Committee on Medicines Scheduling (ACMS #29) and joint ACMS/ Advisory Committee on Chemicals Scheduling (ACCS) meetings (ACMS-ACCS #24), March 2020.
The AMA does not support the down-scheduling of medicines unless there is strong evidence it is safe to do so, and there is demonstrated patient benefit and safety in dispensing the medication by this method.
Regulation through the My Health Record
The AMA’s view is that if additional supply requirements or controls are required in order for pharmacists to safely dispense a medicine, then it is – by definition – unsafe and inappropriate to down-schedule that medicine.
The AMA understands that the scheduling changes for rizatriptan, melatonin, and adapalene, include an obligation for pharmacists to enter the details of the supply of these medicines into the patient’s My Health Record. My Health Record includes a Medicines view that lists PBS Medicines prescribed and dispensed but healthcare providers are not obligated to use it with every patient or for every encounter. An individual’s My Health Record may not include a record of every interaction the patient has had with the health system or an up-to-date status of their health. One in ten Australians do not have a My Health Record1.
The My Health Record was never designed to replicate the full clinical notes curated by the patient’s treating medical practitioner and is an inappropriate tool to be used by non-clinician pharmacists to inform clinical judgements about the appropriateness and risks of administering medicines to individual patients. The My Health Record is also consumer facing and patient controlled. Privacy, security and consent aspects of the My Health Record permit patients to set record access codes to limit access to selected healthcare providers, control access to specific documents, remove documents or delete their entire record. Consequently, the AMA opposes reliance on pharmacy uploads to the patient’s My Health Record to support down-scheduling medicines that without the My Health Record would otherwise be considered unsafe to supply over the counter. Decisions to down-schedule medicines should be decided on clinical merit.
Further, the Committee needs to consider how such an obligation would be enforced and monitored given the privacy and security nature of patient’s My Health Record.
Referring to down-scheduling generally, the AMA reiterates its concern that there is, in effect, no compliance or enforcement mechanisms except through a complaint being brought to the Pharmacy Board or the relevant State/Territory government agency. Without any monitoring or reporting mechanisms in place it is likely that non-compliance will only come to the attention of these bodies when a patient suffers an adverse event.
----- End Extract
Here is the link:
https://ama.com.au/system/tdf/documents/AMA%20submission%20to%20the%20TGA%20-%20pr~tandard%20-%20March%202020%20proposals.PDF?file=1&type=node&id=51898
Here is the link:
https://ama.com.au/system/tdf/documents/AMA%20submission%20to%20the%20TGA%20-%20pr~tandard%20-%20March%202020%20proposals.PDF?file=1&type=node&id=51898
This is clearly a ‘brain fart’ on the part of the TGA (or whoever). The #myHealthRecord is totally inappropriate as a manager of this sort of information where completeness, timeliness and accuracy are important.
This is as stupid policy suggestion as I have ever seen and I have seen some beauts!
David.
6 comments:
I would not be surprised if this is one of many go emerge. All crafted during the myhr gold rush which has now waned and leaves a trail like this TGA submission as reminders just how well Tim, Rowan and Bettina stuffed this up. Not just policy implementation and communications but more broadly.
Inappropriate and unwise I would say. I beggars belief that anyone would have thought that this was a good idea.
Much the same can be said for adding investigation reports directly to the myHR. Send them to the patient's GP where they can be interpreted and managed.
Just because someone somewhere can do something doesn't mean that that they should do it.
From the Prime Minister, Scott Morrison, down to Health Minister Hunt and the Health Department bureaucrats, there is still no understanding that the My Health Record is a gigantic folly continuing to cost the Australian taxpayer millions of dollars.
The Treasurer, Josh Frydenburg, and the Finance Minister, Mathias Corman, seem incapable of understanding that these millions of dollars need to be put to good use elsewhere.
Why is such stupidity allowed to prevail among our politicians? Have they no common sense?
Party politics has always played a part but then the stupidity really began when John Howard politicised the public service. Frank and fearless advice is now in short supply.
This contributes to the problem:
It's time we clipped the ministerial wing of its protected species - the advisers
https://www.smh.com.au/politics/federal/it-s-time-we-clipped-the-ministerial-wing-of-its-protected-species-the-advisers-20200213-p540j0.html
The madness is not limited to myhr.
There's these two debacles to be laid at the feet of the Health Department:
Aged care helpline: more than 100 calls a day went unanswered
https://www.smh.com.au/politics/federal/aged-care-helpline-more-than-100-calls-a-day-went-unanswered-20200212-p54000.html
The tick-a-box GP - a bureaucrat's dangerous fantasy
https://www.smh.com.au/healthcare/the-tick-a-box-gp-a-bureaucrat-s-dangerous-fantasy-20200216-p5418y.html
And of course Robodebt and the sports rorts
Politicians and their advisers are not stupid - they play the game as they see it. Morals, ethics and common sense take a back seat to the acquisition of power. Using it wisely takes a different set of priorities.
In short, the country gets the politicians it deserves.
Now might be a good time to have a look at the sort of "evidence" and predictions that the government has used in the past to justify the PCEHR/myhr.
That well known body HIMSS held a conference Digital Healthcare Week, in Singapore in 2013.
There was a presentation from two people who (AFAIK) were active in NEHTA at the time it was being proposed and developed.
Here is a copy
http://www.drbrd.com/docs/BAFear.pdf
It is worth browsing to have a look at the dewy eyed predictions - based on what, we don't know, there is certainly no evidence or references, apart from a case study on Lombardia Italy
The slide on page 13 is interesting as it was quoted in the Royle review (minus the PCEHR call-out. Funny that)
The slide says:
Direct benefits from digitizing the healthcare sector can be measured – the challenge is realization
Australian Steady-State Annual Benefits by eHealth Application
(AU$ M, Year 2020, assumes full eHealth scope and international benchmark adoption rates)
The myhr failed to get adopted so they went for opt-out,, which puts it way ahead of benchmark adoption rates.
The PCEHR/myhr is supposed to be delivering benefits greater than $AUD400m/year.
About the only thing that can be said about both the predictions and the government's realiztion is that they have failed miserably.
Maybe the authors should have heeded their own advice on Sides 18-19 - or maybe the bureaucrats held sway.
Maybe they should also have learned from the Lombardia Italy case study.
Here's a recent description of it (admittedly from its vendor, but the Italians seem keen on it):
https://www.gemalto.com/govt/customer-cases/italy-lombardy-service-card
The ADHA's claim that myhr is leading the world in "patient controlled" health records fails to recognise that "patient controlled" is a useless characteristic.
What really matters is that the system does useful things and that people use it - just like the Lombardia Italy systems, which they have been rolling out since 2016 and which goes national this year.
The problem Australia has is that its population does not trust its own government, even if there is a high-value and demonstrable proposition.
The reaction to myhr has largely been meh! The Australia Card and the Human Services Access Card were met with opposition. myhr has just been ignored - arguably the greatest insult possible, apart of course, not being trusted.
And let's not forget that the HIMSS is where ADHA's ex-CEO has sailed off to. He'll probably fit in quite well.
There is an article in today's Guardian about the RoboDebt debacle.
Coalition says it has no duty of care for welfare recipients over robodebt
https://www.theguardian.com/australia-news/2020/feb/18/coalition-says-it-has-no-duty-of-care-for-welfare-recipients-over-robodebt
It says, in part
"As the Coalition refuses to provide its legal advice about the scheme to a Senate inquiry, documents filed in the federal court reveal the government has conceded that debts issued using tax office income summaries could “not be validly established” under the law.
But in the documents, obtained by Guardian Australia, the government argues it should not be required to pay compensation because social security law makes no mention of a need to exercise “due or reasonable care”.
While a federal court order striking out a Melbourne woman’s debt suggested the government now considers parts of the scheme unlawful, its defence to a class action filed by Gordon Legal represents its first public statement conceding that it issued potentially thousands of debts that were not valid under the law."
That's an interesting defence - "...it should not be required to pay compensation because social security law makes no mention of a need to exercise "due or reasonable care". "
I had a look at the latest myhr legislation
https://www.legislation.gov.au/Details/C2019C00337
and guess what? - no mention of "due or reasonable care".
I guess we shall have to see if the government ever has to resort to that defence in a myhr court case in the future.
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