Friday, 15 April 2016

Submission Sent Yesterday To Department Of Health On Digital Health Strategy

Submission Sent Yesterday To Department Of Health On Digital Health Strategy

Response To Draft Digital Health Strategy - Dr David More - April 2016
Having been sent multiple copies (presumably due to my voluntary unpaid role as the owner and operator of the Australian Health IT blog  (http://aushealthit.blogspot.com) from diverse sources I have had the opportunity to review this document:
eHealth Working Group (EHWG)
A National Digital Health Strategy for Australia
July 2016 - June 2019
DRAFT 24 March 2016 Version 0.2
I believe my commentary should be of value to the EHWG and The Department Of Health as I am both a retired senior clinician as well as having decades of  experience in Health Information Technology and Strategic Planning as well as having operated the above mentioned  blog for over a decade.
The blog’s comment capability (both anonymous and identified) permits a valuable assessment of the views of the e-Health Community and provides very acute feedback when I make comments which are not seen as being correct.
The blog also has a poll capability.
The present poll allows an overall assessment of the draft Strategy to be offered by blog readers: As of late Wednesday (after just four days) the following results are seen:
How Do You Rate The Recently Circulated Draft National Digital Health Strategy?
Excellent 9% (11)
Good 8% (10)
Neutral 2% (3)
Poor 43% (56)
Just Awful 37% (48)
I Have No Idea 1% (1)
Total votes: 129
It is clear the blog community’s assessment is quiet negative.
I have created two blog posts which cover most of my views on the draft document and highlights the areas which need to be addressed:
First there was:

Friday, April 08, 2016

The Department of Health Releases A New Draft National Health IT Strategy. How Did They Do? Not Well I Fear.

This e-mail and an attachment were sent out on April,4, 2016.
“Dear Colleague
Attached is a copy of the draft National Digital Health Strategy 2016-2019 (the Strategy) for your review and comment. This Strategy has been developed in order to replace the previous 2008 National eHealth Strategy. The Strategy, once fully developed will be presented to the Australian Health Ministers Advisory Committee (AHMAC) before being recommended to the COAG Health Council for endorsement. This version is an early draft which not yet been considered officially, and as such does not currently have any formal status. We also appreciate that there is still work to be undertaken on the presentation of the document.  What is important, at this stage, is to gain your feedback in relation to the content of this document.  We are sending you this draft as part of a closed consultation process, and ask that you limit distribution and discussions on it to a representative group of your members at this stage.
The Strategy aims to recognise the need for increased collaboration across governments, healthcare providers, healthcare consumers, the private sector and software vendors to deliver an integrated digital health eco-system that supports healthcare provision within Australia. While it articulates the government programmes to be delivered, it's intended to provide certainty for private sector technology and innovators to encourage and foster innovation by the non-government sector. It acknowledges the need for real, consistent and ongoing engagement with consumers and healthcare providers in the design of digital health solutions.
The Strategy acknowledges the health system is changing rapidly, with new models of healthcare being regularly developed in response to opportunities, challenges and demands on the health system. Many of these changes are being driven by improved use of data.  Technology is also rapidly evolving, and consumer and healthcare provider expectations of digital health solutions are increasing as they are exposed to advanced innovative solutions in other sectors such as retail and banking.
We will update the Strategy based on the comments that we receive from you and others during the consultation period.  Once the Strategy has been endorsed, the Australian Digital Health Agency will take responsibility for the ongoing development, coordination and implementation of the Strategy through the National Digital Health Work Programme.
Any questions, comments or feedback that you have on the Strategy should be forwarded to James Robertson at James.Robertson3@health.gov.au by 14 April 2016.
Regards
Paul M.
Paul Madden
Deputy Secretary and Special Adviser
Strategic Health Systems and Information Management
----- End Extract.
As you might expect I have had a number of copies forwarded to me as I was not on the original distribution list. (the full distribution list was provided to all recipients in what seems to be a minor security leak).
I have read the document through and have contributed my thoughts to one of the groups who were asked to respond. Sadly I can’t reproduce the document on the blog but I have made it available here for download:
I am making this file available to readers as I see them as part of a special group who have a major interest in the future of Digital Health and who need to have a say.
My thoughts are in 2 parts. My general response is that the present document has a very long way to go before it could be considered even vaguely satisfactory.
As far as specifics are concerned I would make the following points (in no particular order):
First I believe there are so many gaps in the work I believe the document is not really worthy of being described as a strategy - it is more just a really unconnected series of assertions and desires.
Second the document lacks any real insight into the current Health IT situation in Australia, especially it largely ignores the wide range of successful private sector initiatives.
Third, there is no clarity provided as to just who the intended audience for the strategy is and just who are to be assisted and supported by the plan. Is it for clinicians, consumers, the jurisdictions the Department of Health, the private sector or a mix/combination of all of the above or something else?
Fourth, as previously noted in this blog almost decade ago, a strategy without a funding plan and commitment is the emptiest of strategies / plans.
Fifth there does not appear to be anything that could be described as an implementation plan.
Sixth the current document totally fails to review the 2008 National E-Health Strategy to draw  lessons on just what matters in actually delivery of a Strategy and fails to analyse where the successes and failures lay and why.
Seventh it is clear that the present document has been inadequately consulted on with many stakeholders largely ignored and no real consultative processes conducted, with an overwhelming predominance of Government staffers.
Eighth the document is excessively focused on the myHR and while recognising it is not fit for purpose - suggests the need to press on while trying to fix it. If ever you saw a chicken and egg problem - this is it!
Ninth the current document  fails to grasp that Health IT needs to clearly recognise at least two customers - of which the health care providers are the most important - for the strategy (the other is the public/consumer). It is not clear the same solution can work for both classes of stakeholders.
Tenth the document is really weak on evidence, benefits analysis, overseas research and a realistic technology assessment and future analysis.
Eleventh there really is not a clear strategic situation assessment and a future vision.
Last it is not clear just how this document relates to the nascent Digital Health Authority - which is meant to be a strategic organisation.
Overall this document has a very long way to go I believe before being a half useful contribution to the state of play.
I would ask that those who are interested download the document and comment - I am sure DoH will have someone having a browse of the comments!
David.
Dr David More MB PhD FACHI
There were 14 comments made which can be reviewed from this link:
There was a second post a few days later:

Sunday, April 10, 2016

Maybe, Just Maybe, There Is Some Reality On The myHR Emerging. Not Before Time But They Are Still Not Really Accepting The Scale Of The Mess!

As part of the recently released draft Commonwealth Digital Health Strategy we read the following:

9.1 My Health Record

The national My Health Record system was launched on 1 July 2012, as the Personally Controlled Electronic Health Record (PCEHR). The My Health Record system is a secure online summary of an individual’s health information.  The individual is able to control what goes into their My Health Record, and who is allowed to access it.  An individual’s My Health Record allows an individual and their healthcare providers to view and share the individual’s health information to provide the best possible care.
In order for the My Health Record system to be successful the following need to be addressed in the next three years:
·         A critical mass of consumers registered;
·         Active participation by healthcare providers, to both contribute clinical content and to use the information to inform clinical care;
·         Sufficient clinical information available to make accessing the content worthwhile;
·         Clinical information included of sufficient quality for healthcare providers to be able to confidently use the information for clinical care; and
·         The use of the My Health Record needs to be embedded within the clinical practice and workflow of healthcare providers.
Strategies to address these goals have been reflected within strategic initiatives throughout this document.
Following a recent architectural review of the My Health Record system, it has been recognised that changes are needed to the design of the underlying My Health Record system technical infrastructure in order to meet emerging and future clinical requirements.  These changes will be considered within this current planning period.
----- End Extract. (p39)
At the end of the same section we also read:
National Strategic Initiatives
S8.1 Design and implement changes to the My Health Record system technical infrastructure in order to meet emerging and future consumer and clinical requirements.
8.2 Develop and make available a My Health Record system release and development roadmap.
S8.3 Implement changes to the authentication services for connectivity to digital health solutions, focusing on improving registration and renewal processes for healthcare providers and organisations and to rationalise the number of authentication certificates required.
S8.4 Establish better alignment of the roadmaps for the National Health Services Directory, including the National Endpoint Proxy Service, with the other strategic initiatives detailed within this strategy. 
(p40)
All this is just amazing. What we have is the Government out there compelling a million or so citizens to be allocated a myHR, while admitting, explicitly,  the present myHR product is simply not up to scratch.
Just what rationale can there be for not undertaking the re-design and re-implementation work - as well as, of course, addressing all the known issues (security, privacy, access controls, usability etc.) -before conducting the ‘opt-out trials’?
How on earth can the impact of opt-out be evaluated when the present mess is being trialled rather than a system that might actually be useful and clinically acceptable - assuming that the present myHR is reparable - which I very much doubt. No matter what is going on - the trials should not proceed until the myHR is shown to be fixable and then fixed and tested!
Seems someone is very keen to spend our money in a heck of a hurry for no good reason!
It is worth noting that points S8.3 and 4 highlight there is still a lot more work needed in the basic e-Health infrastructure as well.
David.
Note: For more information or to download the draft plan go here:
D.
Dr David More MB PhD FACHI
Here is the link to the blog and comments:
All of the above reflects my own views but in discussions with various Colleges and Professional Associations I have found an amazing level of agreement with concern and frustration with what has been offered within this document.
Clearly the document, as it stands, is simply not fit for purpose and needs a great deal more work to address all the issues I, and others, have raised.
The failure to produce a dramatically improved version of a National Digital Health Strategy will confirm the widely held view that the Department simply both does not listen and does not know what it is doing.
I would be  more than happy to discuss and review future drafts.
Dr David More MB, BS, BSc, PhD, FANZCA, FCICM, FACHI.
14 April, 2016

Baca selengkapnya

Thursday, 14 April 2016

The Macro View - General And Health News Relevant To E-Health And Health In General.

The Macro View - General And Health News Relevant To E-Health And Health In General.

April 14  Edition
The macroeconomic stresses seem to have eased a little more with markets rising or stable around the world.
With Budget Night now May 3 we won’t have long to wait to see what is happening. The Budget now seems to now be very minimalist with any major reform seemingly off the table.
Given it is only 3-4 weeks away I guess we just wait and watch.
Here is a summary of interesting things up until the end of last week:
-----

General Budget Issues.

COAG: Turnbull warns states — don’t come to government for money

  • The Australian
  • April 3, 2016 3:03PM

Rachel Baxendale

The states must stop asking the commonwealth for more money and live within their means after rejecting the opportunity to take responsibility for raising the taxes to fund health and education, Malcolm Turnbull says.
The Prime Minister told Sky News the premiers’ “quick and clear ‘no’” to his proposal at last week’s Council of Australian Governments meeting that they levy their own income tax revealed that they have no credibility in demanding funding increases from his government.
“When they were offered the opportunity to be able to levy a portion of income tax themselves, and have the ability in due course to raise it or indeed lower it, they had no appetite for it,” Mr Turnbull said.
-----

Defining budget leaves Malcolm Turnbull with a deficit of time

  • The Australian
  • April 4, 2016 12:00AM

Phillip Hudson

At the weekend, Malcolm Turnbull reached 200 days as Prime Minister, but it is the next 100 days that will define his leadership.
There are just 29 days until Scott Morrison hands down the fast-tracked budget. It will be his first as Treasurer but must create the springboard for Turnbull to immediately contest his first election as leader. They will rise and fall together.
This week, the pressure will be intense as the expenditure review committee meets to make some of the big decisions about the May 3 budget.
Turnbull will attend and chair some of these sessions.
-----
3 Apr 2016 - 3:46pm

Key to surplus not higher taxes: Turnbull

Prime Minister Malcolm Turnbull insists that eliminating unjustified spending and growing the economy faster is the best way to return to a budget surplus.
Source: AAP  3 Apr 2016 - 3:46 PM 
Prime Minister Malcolm Turnbull insists returning the budget to surplus is a long-term project that will be achieved through growing the economy faster rather than raising taxes.
He says the government's approach is to eliminate unjustified spending, live within its means and maintain strong economic growth that boosts tax receipts.
"It's been very effective in other times and in other places, and is exactly how (New Zealand Prime Minister) John Key got back into balance," Mr Turnbull told Sky News on Sunday.
-----

Malcolm Turnbull and the Liberals are channelling the Tea Party

Date April 4, 2016 - 5:35AM

Jessica Irvine

Senior Writer

Malcolm Turnbull says the states' rejection of his income tax plan shows a weak commitment to reform. Vision courtesy ABC News 24.
It's a curious sort of person who joins an organisation with the sole purpose of diminishing it.
Most people are drawn to certain employers or professions through a core belief in what that profession seeks to do. Their desire is to participate in the purpose of that organisation and expand upon it, if possible.
Spending, is, in fact, the entire project of government.
-----

Morrison signals frugal election budget

April 4, 20161:50pm
Morrison aims to lift business tax burden
By Colin Brinsden, AAP Economics Correspondent AAP
Morrison signals frugal election budget
The Turnbull government has dusted off an old slogan a month out from the federal budget.
While "living-within-our-means" signals a frugal affair, Treasurer Scott Morrison is still leaning towards cutting business taxes as he prepares for his first and only budget ahead of an election.
"We want to see the tax burden moderated for Australians and particularly for businesses that are out there employing people and driving the growth that we need to drive jobs," Mr Morrison said on Monday.
-----

Tax changes will be in 2016 federal budget, Assistant Treasurer Kelly O'Dwyer says

By political reporter Stephanie Anderson and Louise Yaxley
Updated yesterday at 2:54pm
Assistant Treasurer Kelly O'Dwyer has insisted there will be tax changes in the federal budget, less than a week after the Prime Minister was forced to withdraw his proposed changes to income tax arrangements.

Key points:

  • Government is examining country's tax mix, rates and concessions, Kelly O'Dwyer says
  • Treasurer says he will not make "unfunded, fantasy promises"
  • Labor accuses the Government of trying to get states to put up income taxes
Premiers and chief ministers rejected Malcolm Turnbull's plan for states and territories to levy a percentage of income tax independently.
-----

Financial and political future of country all comes down to Super Tuesday

April 5, 2016 10:00pm
Terry McCrann Herald Sun
TUESDAY May 3 has become the day on which the entire financial and governing future of the country — Budget, interest rates and both politics and policies — will now pivot.
For the first time in the quarter century or so since the governor of the Reserve Bank ‘escaped’, so to speak, from then-treasurer Paul Keating’s pocket and took sole ownership — and so total responsibility — for interest rates, we will have an RBA rate meeting and the federal Budget on the same day.
Just to make it that much more ‘interesting’, both the RBA meeting and the Budget will be ‘live’, so to speak again. And the Budget will effectively ‘ring the bell’ to start the federal election campaign.
-----

Tax plan ‘bluff’ seen as spin to cover error

Treasurer Scott Morrison says Malcolm Turnbull was calling premiers’ “bluff” with his proposal to reinstate State income taxing rights.
There are also signs Labor will retreat from Julia Gillard’s $80 billion pledge for hospitals and schools.
Mr Morrison said the Prime Minister had exposed the States’ resistance to taking responsibility for their own budgets.
“What the Prime Minister did last Friday is call their bluff,” he told Sydney radio yesterday.
-----

Labor to appeal to women voters in stoush over superannuation

Date April 5, 2016 - 12:08PM

Sally Rose

Reporter

Labor superannuation spokesman Jim Chalmers has said gender equity will loom large in the election battle over super policies. Photo: Glenn Hunt
Labor has slammed the government's failure to reveal its plans for superannuation taxes and indicated it will seek to appeal to women in the the tussle over any changes announced in the May budget and in the lead-up to a federal election.
It comes as the latest Newpoll survey shows Labor ahead of the Coalition government for the first time since Malcolm Turnbull became Prime Minister.
By not announcing its plans for super taxes the government has left the opposition flat-footed in its ability to critique them.
-----

The budget deficit is at its lowest in two years

Chris Pash Apr 6, 2016, 3:48 PM
The underlying budget deficit has dropped to $36.1 billion, its lowest in almost two years, according to Department of Finance numbers.
The figures for February put the Federal Budget on track to meet forecasts, according to analysis by CommSec.
They are a result of lower spending more than making up a shortfall in revenue.
Total revenue was $1.22 billion weaker than the mid-year forecast mainly because tax collection didn’t meet expectations.
-----

Coalition has hard sell convincing voters of need for restraint

  • The Australian
  • April 7, 2016 12:00AM

David Uren

Scott Morrison’s strategy for ­repairing the budget deficit is to keep government spending growing more slowly than the economy overall and wait for economic growth to increase tax payments to a level that ­delivers a surplus.
It is, the Treasurer acknow­ledges, a slow and hard slog, with uncertain deadlines. There is the constant need to resist fresh government spending and find fresh savings when those efforts fail.
His goal is to get federal government spending down from 26 per cent of gross domestic product to 25 per cent, arguing that Australia has never achieved surpluses when spending is greater than that level.
-----
  • Apr 7 2016 at 11:45 PM

Government scraps plans to trade away tax deductions

The federal government has scrapped plans to trade away annual work-related deductions to find revenue to fund other tax cuts after concluding it would not stack up either economically or politically.
The decision to leave tax deductions unchanged, which is related to the earlier decision to leave the rate and base of the GST unchanged, has further limited options for what is a politically critical May 3 budget for the government which will contain tweaks to superannuation tax concessions and limited measures targeting small and medium business.
The Australian Financial Review understands that while it remains the government's intention to offer a company tax cut, the beginning of any phase down in the 30 per cent rate may be delayed.
-----

A wealth of unfulfilled budget reform opportunities

  • The Australian
  • April 9, 2016 12:00AM

Judith Sloan

I am one of a small number of people who found some merit in the 2014 budget. It did aim to restrict the growth of government spending and rein in the deficit. But, from a political point of view, it was a turning point. Seemingly unable to secure passage through the Senate of most of the key savings measures, the government quickly descended into chaos and mixed messaging.
Last year’s budget was a classic case of offending no one, although the previous budget’s $80 billion of savings in payments to the states for hospitals and schools were kept on the books.
In point of fact, the Abbott government had got off to a good start. The line was held on extending corporate welfare to the car industry and SPC Ardmona. A bunch of pointless and expensive agencies was abolished, with more to come. Arthur Sinodinos, then assistant treasurer, got on with the job of wading through the close to 100 tax measures left over from the Labor government that had never been legislated.
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Federal budget 2016: Scott Morrison signals tough approach focused on spending cuts

Date April 8, 2016 - 10:01AM

James Massola

There'll be no fantasy funding according to Scott Morrison who says we have to live within our means. Courtesy ABC News 24.
Treasurer Scott Morrison has given the clearest signal yet his election year budget will place spending restraint front and centre, with the prospect of "big bang" tax reform rapidly receding.
The Turnbull government is whittling down the number of tax changes that could be adopted in the May 3 budget, with a rise in the GST already off the table and a plan to offer simplified tax returns - which would have raised as much as $6 billion in revenue to pay for tax cuts - now apparently off the table.
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PM says looming budget won’t be about ‘a fist full of dollars’

  • AAP
  • April 9, 2016 5:58PM
The Turnbull government’s first federal budget will be prudent and responsible and won’t hand out a “fist full of dollars”.
The prime minister on Saturday began the task of managing public expectations ahead of the May budget, warning it would focus on living “within our means”.
However, he confirmed his first budget would contain “changes to our tax system” designed to promote investment, innovation and enterprise.
“This budget will not be about a fist full of dollars, it will be about prudence, fairness and responsibility to our future generations,” he told the Victorian Liberal Party conference in Melbourne on Saturday.
-----

Health Budget Issues.

Budget 2016: UBS analysts don’t expect health cuts in election year

  • The Australian
  • April 6, 2016 11:23AM

Sarah-Jane Tasker

UBS analyst Andrew Goodsall says despite his view that healthcare cuts are less likely in an election budget, the growing budget deficit remains a constraint on largesse.
The Turnbull government’s May budget could “showcase” new policies it plans to take to the election on innovation and research, according to healthcare analysts.
UBS analyst Andrew Goodsall also outlined that despite his view that healthcare cuts were less likely in an election budget, equally the growing budget deficit remained a constraint on largesse.
“Given major reform processes (in healthcare) underway, we generally expect a more subdued approach to further healthcare reform in budget 2016,” he said.
The respected healthcare analyst pointed out that federal funding represented more than 70 per cent of income for some of the major Australian-listed healthcare stocks.
The budget, he said, was likely to provide updated projections on recent policies, such as bulk-billing incentive cuts, updated forecast for pharmaceutical benefits scheme spending after existing pricing savings, along with the Medicare Benefits Schedule freeze.
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Claims health tests are in danger

April 7, 2016 9:55am
MATT SMITH State Political Editor Mercury
Hobart Pathology chief executive Lawrie Bott says a cut to bulk-billing incentives will force his company, which does the majority of pathology testing in Tasmania outside of the public hospitals, to introduce out-of-pocket charges.
TASMANIA’S largest pathology services provider has warned life-threatening diseases may not be detected after Federal Government cuts take effect on July 1.
Hobart Pathology chief executive Lawrie Bott says a cut to bulk-billing incentives will force his company, which does the majority of pathology testing in Tasmania outside of the public hospitals, to introduce out-of-pocket charges.
The Government wants to scrap bulk-billing incentive payments for pathology services (worth $1.40 to $3.40) which, along with changes to bulk-billing incentives for diagnostic imaging, would save $650 million over four years.
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The problem ingrained in our health system: patients don't come first

Date April 8, 2016 - 12:15AM

Vlado Perkovic and Leanne Wells

Over the past six months, companies such as Novartis Pharmaceuticals and Amgen Australia have spent millions sending health professionals on junkets all over the world.
Most aspects of health care have been designed with a focus on the needs of the doctor or other health care provider, rather than the consumer who uses the health services.
But health care is ripe for change.
This culture has not been deliberately created, and often frustrates doctors and other health providers as much as patients. But it is ingrained in our health care system.
-----

Fact check: Has the Coalition taken billions of dollars from hospitals and not put it back?

The claim

On April 1, 2016 following a Council of Australian Governments (COAG) meeting, the Governments of the Commonwealth, states and territories reached an agreement on hospital funding for the three-year period beginning July 1, 2017.
The Commonwealth is to provide up to $2.9 billion of additional funding to the states and territories over the three years, but some leaders have argued it is not enough.
"[H]undreds of millions of dollars today in extra funding for Victorian hospitals does not replace billions of dollars that have been taken away from Victorian hospitals...[M]any billions of dollars will not be flowing to hospitals in my state and hospitals right across the nation as a result of decisions made in the 2014 budget. They are not reversed today and that's a really important point for us all to acknowledge..."
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Pharmacy And Drug Issues.

Hundreds of prescription drugs will now be cheaper

April 3, 2016 8:48pm
Megan Palinnews.com.au
HUNDREDS of lifesaving prescription drugs will be cheaper as changes to the Pharmaceutical Benefits Scheme come into effect this weekend.
More than 400 prescription drugs have dropped up to $20 in price, including expensive cancer and cardiovascular disease pills.
Prices for some drugs will drop as much as 60 per cent from this weekend as annual changes to the Pharmaceutical Benefits Scheme take effect.
-----

Medicines sector reforms deliver consumer benefits and a sustainable PBS

Consumers, taxpayers and the national health system will benefit from the significant savings being delivered by medicine suppliers since 1 April, say Medicines Australia, the Generic and Biosimilar Medicines Association, the Pharmacy Guild and the National Pharmaceutical Services Association.

The direct contribution the medicine supply chain is making to these savings will ensure the PBS is sustainable into the future, enabling the reinvestment savings into the funding of new, breakthrough medicines for Australian consumers, they say.
The key players in the medicines supply sector said the consumer benefits of the latest round of PBS reforms—the costs of which are being borne across the sector—are helping to ensure that the PBS remains one element of Australia’s health system that is fiscally sustainable.
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PBS cuts skyrocket

Latest PBS cuts just the beginning, Minister believes

A “skyrocketing” number of medicines experiencing a reduction in their price in the April round of PBS cuts is only the beginning, Health Minister Sussan Ley says.
Over the weekend, Ms Ley announced that the price of around 400 medicines will fall as a result of the 1 April round of PBS reforms that are being funded by the medicines supply sector, and which took effect on 1 April.
“In an Australian first, the price of a large proportion of expensive combination medicines and patent-protected drugs listed on the Pharmaceutical Benefits Scheme will drop this weekend, in addition to the annual April changes,” she said.
-----

Patients could miss out on leading drugs: pharmaceutical firms

  • The Australian
  • April 5, 2016 12:00AM

Sarah-Jane Tasker

Pharmaceutical companies have warned Australian patients risk missing out on leading new drugs after the federal government cut the price of hundreds of medicines.
The government reduced by 5 per cent the price of branded medicines that have been on the Pharmaceutical Benefits Scheme for five years or more, and pharmaceutical companies say they will be forced to wear the discount.
Carlo Montagner, the chief executive of Specialised Therapeutics Australia, said if there were further price cuts, companies might remove drugs from the PBS because it would not be viable to keep them on the list.
-----
Health is also clearly still under review as far as its budget is concerned with still a few reviews underway and some changes in key strategic directions. Lots to keep up with here with all the various pre-budget kites still being flown - although narrowing it seems to be largely focussed on Super! Enjoy. Only a few weeks to the Budget.
David.
Baca selengkapnya
The More Things Stay the Same - More Apparently Adulterated Heparin, This Time from Chinese Ruminants

The More Things Stay the Same - More Apparently Adulterated Heparin, This Time from Chinese Ruminants

The story of the contaminated heparin just will not go away.  We first wrote about it in 2008 (see first post here, most related posts here, and the longer summary at the end of this post.)

Quick Summary

Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.

Here We Go Again

At the end of March, 2016, per Bloomberg,

Heparin tainted with unauthorized Chinese-made ingredients may be on the market in the U.S. and the Food and Drug Administration hasn’t moved swiftly enough to prevent it, according to a congressional probe nearly a decade after hundreds of deaths were linked to sullied batches of the blood-thinning drug.

This possible contamination is different from the earlier one, when Chinese producers made crude heparin containing a deadly chemical. They may be using cow and sheep intestines to produce the raw material for heparin that is supposed to be derived only from the intestinal membranes of pigs, according to a letter the House Energy and Commerce Committee sent Tuesday to the FDA. The agency has known about the risky practice since 2007, around the time it discovered the chemically enhanced crude heparin, the panel said.

The FDA didn’t react early on 'to credible evidence of non-porcine contamination of the Chinese heparin supply,' according to the letter, only putting out testing guidelines for pharmaceutical companies in 2012. Even after the tragedy of the chemically soiled heparin, the committee said, 'loopholes and exemptions that permit part of the Chinese drug supply chain to operate outside government scrutiny still remain.'

The committee charged that nothing much as changed since the 2008 episode of deadly heparin made from Chinese pigs

The letter from the House committee said the FDA dropped the ball on many fronts and may have allowed unsafe blood thinners to remain on the market longer than necessary. Regulators didn’t properly or widely enough share information and didn’t follow up on leads about tainted heparin from other governments, according to the letter. Agency investigators failed to inform others about dodgy crude heparin makers, the panel said. It also said the FDA didn’t follow up on concerns that heparin with the chemical was recycled after the poison was removed and may have entered the U.S. market. The claims are based on documents that Baxter, Scientific Protein and FDA provided the committee as well as interviews with FDA employees, according to footnotes in the letter.

Also, efforts to investigate the 2008 problem seem to have failed,

The chemical, oversulfated chondroitin sulfate, was connected to 246 deaths and sickened hundreds of people who took the blood-thinning medicine, the FDA said at the time. Regulators never found at what point in the chain in China that the drug, sold in the U.S. by Baxter International Inc., was corrupted. The FDA closed its initial criminal investigation after it became difficult to obtain evidence in China, though it has since re-opened a related inquiry, according to the House committee. Baxter, which recalled its heparin in 2008, hasn’t sold the anticoagulant since. It said at the time it was alarmed that the contamination appeared to have been deliberate, but had no proof of how it happened.


Now the problem appears to be more bovine. It appears that French regulators first noted the problem of imported heparin derived from Chinese cows.

The French National Agency for Medicines and Health Products Safety called non-pig blending a 'critical' violation in an inspection report released in February. France cited China’s Dongying Tiandong Pharmaceutical Co. for making heparin with ruminant DNA, which includes cows and sheep. Dongying is registered with the FDA as a manufacturer of active ingredients and isn’t on the agency’s list of companies banned from importing to the U.S.

Yet, the FDA

considers heparin adulterated if it contains oversulfated chondroitin sulfate or non-pig material, according to an FDA document for the pharmaceutical industry on monitoring heparin quality. Material from cows could pose a risk because of possible contamination with mad cow disease.
Oddly enough, the Bloomberg article did not mention any criticism by the committee of the US based manufacturers who outsourced their heparin production to China.

Outsourcing Continues Unabated


In 2012 we noted that outsourcing by big multinational drug companies based in the US and other developed countries of active pharmaceutical ingredient (API) production to dubious manufacturers based in countries with much less robust regulation was continuing.  I wrote then

To put it more directly, most so called pharmaceutical companies in the US and other developed countries have outsourced the actual manufacturing of drugs. Thus, most companies that appear to be pharmaceutical manufacturing companies are really just pharmaceutical marketing and development companies. (And not so much the latter, look here:  Light DW, Lexchin JR. Pharmaceutical R&D; what do we get for all that money? Brit Med J 2012; 345: 22-25.  Link here.) Pharmaceutical companies appear to be abandoning their core essence, but are content to market drugs  under their logos without telling the patients who take them the real source of these products.  This would appear to be a big scandal, but one that stays curiously anechoic.

In 2016, outsourcing of drugs by big multinational corporations with prestigious names seems to be continuing at a rapid pace.  Per Bloomberg,

The U.S. depends heavily on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world, according to the National Academies of Sciences, Engineering, and Medicine.

There is still no clear way for US patients or doctors to identify outsourced medicines, and efforts to better regulate them seem feeble. Thus the danger that patients may be getting ineffective, adulterated, even deadly outsourced medicine in bottles with the logos of big, famous pharmaceutical companies seems to be ongoing.

The More Things Stay the Same

In 2012, we wrote

I have yet to see any discussion with pharmaceutical executives about why their companies hardly make drugs anymore. In the absence of such discussion, I can only speculate that most likely, this is first a product of financialization. Drug company executives, like most organizational leaders, have fallen under the spell that says their only goal should be to increase short-term revenues. It may be cheaper to buy drugs from perhaps dodgy outsourced suppliers rather than manufacturing them them themselves. Continuing stories like those above, and that of the contaminated Chinese heparin suggest that these outsourced drugs are cheap for a reason. It appears that to save money short-term, pharmaceutical executives may be abandoning their most central mission, to provide pure, unadulterated drugs.

The continuing story of outsourced pharmaceutical manufacturing provides yet more evidence that current management dogma may be literally toxic. Once again, I suggest that true health care reform requires leadership of health care organization who put patients' and the public's health ahead of short-term revenue (and the personal enrichment that may result).

It is likely that a number of policy changes will be needed to reduce the threats posed by contaminated or adulterated outsourced pharmaceuticals.  There is one simple step that ought to be taken quickly to at least make the problem more transparent.  In the US, most manufactured products have a label disclosing the country of origin.  In parallel with that, all pharmaceutical containers, and all pharmaceutical labels and marketing materials ought to disclose the country in which the active pharmaceutical ingredient was manufactured, and the name and location of the company responsible for that manufacture.

There seems to be no need to rewrite or update this.

The fact that this problem has been known for 2008 year, but not clearly addressed, shows the pitiful state of American health care dysfunction.  But those with vested interests in preserving the current system remain fat and happy, like the pigs of China.

 Appendix - Heparin Case Summary

- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.

- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)

- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post here).

- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

-  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)

-  In February, 2011, a congressional investigation of the case was announced, but results were unavailable until now (see above)

-  In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).
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Wednesday, 13 April 2016

Now This Is A Remarkably Good Question I Believe. Relying On Flawed Infrastructure Might Very Well Ruin The Trial.

Now This Is A Remarkably Good Question I Believe. Relying On Flawed Infrastructure Might Very Well Ruin The Trial.

This appeared last week:
April 4, 2016

Will Health Care Home fail on the back of MyHealthRecord’s fail?

Posted by Jeremy Knibbs
MyHealthRecord appears to be key to engaging with the ‘revolutionary’ Health Care Home Medicare reform, despite being plagued with problems and low GP uptake.
“One is tied to the other,” according to Dr Steve Hambleton, chair of the advisory group that helped shape the pilot and current NEHTA chair.
“I would think that a high-performing Health Care Home would want to opt in,” Dr Hambleton said. “And if you don’t want to be a Health Care Home then you won’t have access to the new funding model.”
While Dr Hambleton said creating the records was “dead easy” and took less than 90 seconds per patient, February saw fewer than 400 GPs updating a shared health summary with the program. 
The 65,000-person trial of the medical home model for chronic and complex conditions would shed light on doctors and patients opting out of the MHR and guide the national implementation of the reforms.
Between July 2017 and June 2019, up to 200 metro and rural general practices will be asked to sign up to the pilot, designed to inform the Health Care Home infrastructure rollout.
The federal government has promised to revolutionise healthcare for patients with chronic and complex conditions, and called it “one of the biggest health system reforms since the introduction of Medicare 30 years ago”. 
Health and consumer groups have come out in support of the move towards a medical home model of funding, with the RACGP calling it a “life-saver”.
However, Dr Bastian Seidel, current chair of RACGP Tasmania, cautioned against overstating the influence of the mere $21.2 million earmarked for the four-year project.
“It’s very easy to do something that underfunded and set it up to fail,” he said. “So you just over-promise and under-deliver, and if we have a look at the funding now we are talking about $100,000 per practice roughly.
“Now you could argue that’s a lot of money, but realistically it’s not that much.”
He pointed out this didn’t come near the $60 million given to hospitals to fix the elective surgery lists, or the $600 million extra money given as part of the Community Pharmacy Agreement to expand into “GP-lite” services.
Nevertheless, Dr Seidel was enthusiastic about the trial, and said that it was reasonable to hope the reform could reduce unnecessary hospital admissions and emergency hospital presentations. 
Lots more here:
With what we have learnt this week regarding the attitude of DoH to the current state of the myHR it is hard to know just why you would attempt to conduct such an important trial (and the trials are really important) using such inferior Health IT support and infrastructure.
It is made even more absurd when you realise there are already much better tools for managing co-ordinated care available in the Australian market place.
Pretty silly I reckon. Looks much like a solution in search of a problem and finding the wrong one to me!
David.
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