This very useful summary appeared a few days ago.
New regulations for e-prescribing and their impact on patent litigation in Australia
We provide an update on changes to electronic prescribing of medicines in Australia, and how this might impact on patent disputes.
Key takeouts
New regulations come into effect on 31 October 2019 that affect electronic prescribing for PBS-listed medicines. The changes do not apply to handwritten prescriptions and certain other types of prescriptions.
The key change is that the active ingredient of the medicine must be named on an electronic PBS prescription, instead of the current practice of stating the brand name only. This is part of the Federal Government's initiatives directed at increasing the uptake of generic and biosimilar medicines.
In future patent litigation it will be important to consider whether these have affected the likelihood of generic and biosimilar medicines being dispensed to patients in place of their branded equivalents.
……
What are the new requirements for electronic prescribing?
In more detail, under the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019 (Cth):
- All electronic PBS prescriptions must include the name of the active ingredient.
- The regulations do not apply to handwritten prescriptions, paper-based medication charts in the residential aged-care setting, and prescriptions for medicines with four or more active ingredients, and items determined by the Secretary to be excluded for practicality and safety reasons.
- Prescribers can still prescribe by brand where clinically necessary, including where the medication prescribed may pose a potential patient safety risk if the brand is not specified, or to promote patient compliance where a patient is familiar with a particular brand.
- Where the prescriber nevertheless makes a clinical decision to specify a brand name on the electronic prescription, the name of the active ingredient must appear first.
- Prescribing software must not default to include brand names on prescriptions. In this way the regulations compel doctors to make a clinical decision regarding inclusion of a brand name.
- Following the 31 October 2019 commencement date, there is a 12 month transition period to ensure that prescribers have sufficient time to update their prescribing software to comply with the new requirements.
The full article is here:
What is interesting to me is the increasing push to the use of generic medicines and to note that the switch will hardly be over by the end of the year. The transition to even a majority of prescriptions being electronic will take a good few years I suspect.
Although I can’t explain the reason I also am aware that many brand-name medications are perceived by their takers and not being as effective as the generic – especially with regards to some anti-depressants. I understand many psychiatrists are particularly aware of this and find the differences to be very real.
My rational mind says this should not be so but that is what I hear. That said it is useful to know what the regulations are – now that they are in force.
You can read an optimistic overview here:
http://www.pbs.gov.au/info/news/2019/09/electronic-prescribing
There is similar legal coverage here:
https://www.lexology.com/library/detail.aspx?g=461f78a6-19b3-458e-b934-b5cea6ae47d5
There is similar legal coverage here:
https://www.lexology.com/library/detail.aspx?g=461f78a6-19b3-458e-b934-b5cea6ae47d5
David.
10 comments:
This is the bit that worries me most:
"The Australian Digital Health Agency is developing the technical framework to support electronic prescriptions. This technical framework will detail the requirements for clinical software to ensure alignment with the legal framework, adherence to privacy and security principles and maintenance of patient choice."
This is the bit where "in consultation with" could give bureaucrats an opportunity to meddle big time:
"The technical framework will identify the clinical software changes in consultation with the clinical software sector.
Has anyone looked at workflow implications?
From what I've read, instead of just printing a script, a GP hes to have a dialogue with the patient to identify what sort of script to give a patient. This might be a two second yes/no, or it might take a lot longer.
It's not a technology problem so ADHA will probably just ignore it and heap even more
load onto the poor suffering GP.
Likewise what will be the impact on pharmacists?
The bit that worries me the most is the involvement of ADHA at a technical level.
Worth noting this is entirely driven by PBS Branch in DOH with Agency responding to the direction, artificial requirements and design constraints as best it can. Hence the mandatory active ingredient, therefore AMT/SNOMED CT code. Lots of hunting through search lists/drop downs to follow I expect. .
In my experience with PBS Branch, it's all about the data, nothing about the clinician or workflow.
Four of the Morrison government's signature policies, including recent tax cuts and laws to remove abhorrent images online, have been labelled as policy "on the run" in an annual review of public policy making.
Without passing judgment on the merits of policies, the joint research project by two usually opposing think tanks - Per Capita, on the left, and The Institute of Public Affairs, on the right - has condemned as "unacceptable" the processes used to design eight out of 20 policy case studies at the state and federal level.
Of eight federal policies reviewed, four were deemed to have followed an "unacceptable" process, by failing to adhere to the basics of good public policy making, including: comparing the costs and benefits of alternative options, explaining how a decision would be rolled out and issuing a green and white paper for public consideration.
One federal policy - the redress scheme for victims of child sex abuse - was deemed to have followed a "sound" process.
"Public policy in Australia is often made on the run, built on shabby foundations, motivated by short term political gain, and consequently having mediocre outcomes," said John Roskam, the director of IPA
Another week, no sign of the ANAO report, no more ADHA or DHA statistics. The only #myhealthrecord traffic on twitter is the usual adverts and PR from paid lackies.
Calm before the storm or just complete apathy? Maybe both.
@10:07 PM Tim Kelsey seems be creating plenty of PR. Looking at twitter he seems to continually be at one conference after another and maximising his profile in photo opportunities with Health Ministers and any other suitable and VERY important people he can find.
He does indeed seem to be everywhere and he takes every opportunity to get his "some good news Minister" into Greg Hunt's ear. His marketing rationale is that frequent short information increments consolidates the Minister's view that the overall project is going from strength to strength, day by day.
@3:12PM That's his job to keep My Health Record alive. He's well motivated with an annual salary of $500,000++ peer year. It doesn't have to work just as long as it's kept alive.
Personal wealth, aha, my mistake I incorrectly had been assuming it was patient controlled health. I am guessing open data is open to anyone with cash.
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