News

Deputy CMO requests GP assistance


Paul Kelly


23/04/2020 1:50:18 PM

Professor Paul Kelly has written to RACGP President Dr Harry Nespolon to ask for general practice’s help in managing the current supply shortage of hydroxychloroquine.

Deputy Chief Medical Officer Professor Paul Kelly.
Deputy CMO Professor Paul Kelly said the number of PBS prescriptions of hydroxychloroquine doubled in March.

As you know, hydroxychloroquine is approved by the Therapeutic Goods Administration (TGA) for rheumatoid arthritis, mild systemic and discoid lupus erythematosus and the suppression and treatment of malaria.
 
Hydroxychloroquine is also listed on the Pharmaceutical Benefits Scheme (PBS) as an unrestricted benefit. In recent months, the number of PBS prescriptions supplied of hydroxychloroquine has doubled, from the usual number of 23,000–25,000 per month to 49,000 in March 2020.
 
This unanticipated and likely off-label use is adversely impacting access to this medicine for patients who regularly use it.
 
To try and limit the use of hydroxychloroquine to currently approved indications, an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 was made from 24 March 2020 to restrict initiation of therapy to certain specialists.
 
Please note that there are no changes to the prescribing of continuing therapy. Further information is available from the TGA.
 
The Department of Health is working towards making changes to the current PBS listing for 1 May 2020 to align the PBS listing with the TGA changes, to minimise the risk of PBS prescriptions being supplied to those accessing hydroxychloroquine for unapproved indications, and to ensure that those who regularly rely on this medication will be able to continue accessing it.
 
These changes include the PBS restriction being split into two separate listings for autoimmune conditions and malaria in line with the registered TGA indications, as well as a change from an unrestricted listing to a Authority Required (STREAMLINED) listing, with both an initial and a continuing treatment phase.
 
In line with the recent changes to the Poisons Standard the initial prescription must be authorised by specialist physicians or specialists in dermatology, intensive care medicine, paediatrics and child health, and emergency medicine. However, treatment can be initiated by GPs where it has been authorised by one of these specialists by either written or oral advice, and this is recorded in the medical file.
 
As you know, hydroxychloroquine has been the subject of clinical trials internationally for the management of COVID-19. To date there has been no conclusive evidence demonstrating clinical benefit for the use of hydroxychloroquine in the management of COVID-19 or in its prevention.
 
However, clinical trials continue and Australia is contributing to this research effort.
 
To this end, the Australian Government has secured supply of hydroxychloroquine for the National Medical Stockpile, with the intention of using this supply to support clinical trials and clinical use, should these trials demonstrate benefit.
 
I ask that medical practitioners continue to exercise clinical judgement, balancing the risk of benefits and harms, and confine prescribing to PBS listed and TGA approved indications. I also ask that you circulate this request to your members to ensure that adequate supplies of hydroxychloroquine can be maintained.
 
Log in below to join the conversation.



coronavirus COVID-19 hydroxychloroquine



Login to comment

Dr BT   24/04/2020 6:13:24 AM

Mr Palmer might have a few spare tablets in his garage...


Dr Stuart John Nash   24/04/2020 6:55:49 AM

I’m sorry: but who the hell is giving this stuff out?! I can only imagine it is GPs who don’t know how to say “no”. Lots of patients requesting, but if a new patient, no PMH and no history of scripts then it’s a big fat no from me.


Dr Arshad Hussain Merchant   24/04/2020 7:50:40 AM

1- there is no evidence in use of hydroxychloroquine in COVID 19 infection, so it should not be prescribe by specialist, intensivist, paediatrician or emergency medicine
2- for conditions like RA, it shall be initiated by Rhuematologist
3- there is a big difference and mechanism of action of chloroquine and hydroxychloroquine so please stop confusing
4- pharmacist have equal responsibility in entertaining scripts and bear higher responsibility in medication shortage due to their financial interest. All pharmacies should be audited and named
5- Hydroxychloroquine use shall only be used in trials, approved through ethics committee and all blanketing practice under specialist hat should be stopped.


Dr Daniel Thomas Byrne   24/04/2020 9:01:51 AM

Spot on Dr Merchant. I also must remind members that the PBS already knows whose prescribing of HC has more than doubled.
Sometimes a “please explain” letter from Prof Murphy is appropriate. I think it is in this instance.


Dr Jonathan Graham Wright   24/04/2020 10:28:35 AM

Dr Merchant concise and Brilliant,
We are specialists too. I 'm sick and tired of this type of specialist approach assuming we don't know what we are doing.

Dr Arshad Hussain Merchant 24/04/2020 7:50:40 AM

1- there is no evidence in use of hydroxychloroquine in COVID 19 infection, so it should not be prescribe by specialist, intensivist, paediatrician or emergency medicine
2- for conditions like RA, it shall be initiated by Rhuematologist
3- there is a big difference and mechanism of action of chloroquine and hydroxychloroquine so please stop confusing
4- pharmacist have equal responsibility in entertaining scripts and bear higher responsibility in medication shortage due to their financial interest. All pharmacies should be audited and named
5- Hydroxychloroquine use shall only be used in trials, approved through ethics committee and all blanketing practice under specialist hat should be stopped.


Dr Samuel Lawrence Elliott   24/04/2020 11:00:57 AM

Can we please address the real issue, will the RACGP stop blaming its own constituents. Governments around the world have stockpiled this drug. Seize the stockpile from Clive Palmer who has suggested he has provided his to an Australian Government agency. Cease the clinical trials using hydroxyychloroquine in Australia only replicating what has already been tested overseas with negative outcomes. Our patients with SLE need it now, the government has the solution but would rather blame GPs than implement common sense solutions.


Dr Daniel Peter Ewald   24/04/2020 12:38:14 PM

Was it the anaesthetists/ intensivists self-prescribing that was the problem?
I support the Australian trial going ahead (if they can get the numbers) as we still need much better quality evidence about possible effectiveness than is currently available.


Dr Elias Youssef Samaha   24/04/2020 1:36:37 PM

Why is everyone getting so worked up?

Hydroxycholoroquine works in vitro , may or may not work in vivo , we don’t know as not good enough studies have been published

I think by now we should’ve had enough results from all the trials , but no one is publishing results. I suspect because if something is published than people may stock up

But the UK government is stocking up, the US govt is stocking up, the Aust gov is stocking up, they’re not stupid and they probably have data we don’t have

I demand people with data publish these , there aught to be a mountain of evidence by now because the outcome of COVID is only 14 days ...