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Restrictions placed on ivermectin use in general practice


Matt Woodley


10/09/2021 5:38:40 PM

GPs can now only prescribe the drug, which has been touted as a potential COVID cure, for TGA-approved indications.

Ivermectin graphic.
There is limited evidence to support the use of ivermectin as a treatment for COVID-19.

The Therapeutic Goods Administration (TGA) announced the new restrictions late on Friday afternoon, following increased reports of patients and doctors seeking to use the drug as a COVID treatment and prophylaxis.
 
GPs are now only able to prescribe ivermectin for TGA-approved indications such as scabies and certain parasitic infections.
 
However, specific specialists – including infectious disease physicians, dermatologists, gastroenterologists and hepatologists – will still be permitted to prescribe the drug for other unapproved indications if they believe it is appropriate for a particular patient.
 
‘The TGA, acting on the advice of the Advisory Committee for Medicines Scheduling, has placed new restrictions on the prescribing of oral ivermectin,’ the TGA release stated.
 
‘Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organization and the US Food and Drug Administration.’
 
There has been a 3–4-fold increase in ivermectin prescriptions in Australia in recent months, while in August imports of the drug were reportedly 10 times higher than usual, prompting a warning from the TGA.
 
Pharmacists are also reporting a rise in customers refusing to disclose the reason for their ivermectin prescription, while a Melbourne general practice has been offering $85 ivermectin consultations
 
The growing use of the medication has be fuelled primarily by anti-vaccination groups and right-wing politicians, but there is limited evidence to support its use and it can have significant side effects; Westmead Hospital recently admitted a patient following a self-inflicted ivermectin overdose that resulted in severe diarrhoea and vomiting.
 
According to the TGA, there are several ‘significant public health risks’ associated with taking ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated.
 
‘Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community,’ the release announcing the restrictions states.
 
‘Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment.
 
‘These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, [and] neurological effects such as dizziness, seizures and coma.’
 
The major increase in prescribing has also led to national and local shortages that are affecting patients who need the medicine for scabies and parasite infections.
 
‘Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities,’ the TGA stated.
 
Stromectol ivermectin 3 mg is the only TGA-approved oral ivermectin product. It is indicated for the treatment of river blindness (onchocerciasis), thread worm of the intestines (intestinal strongyloidiasis) and scabies.
 
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Dr Jacqueline Chapman   11/09/2021 6:22:16 AM

Are doctors prescribing Ivermectin under duress or just wanting to make a quick buck? Are patients really so desperate or is it a foolish declaration of their support for the fringe dwellers ? Sad times indeed when the TGA has to step in. Thankfully no one has asked me for a script.


Dr John Lamb   11/09/2021 6:38:09 AM

That will take a bit pressure off some of us. I assume we can still prescribe ivermectin cream for rosacea?


Dr Rama Krishnan   11/09/2021 8:43:38 AM

This paper gives detailed analysis of trails conducted using Ivermectin. I am neither for or against Ivermectin at this stage. WHO had given contradictory statements on Covid inflection right from the start. For example , no human to human transmission 🙄
https://ivmmeta.com/


Dr Anthony Cletus McCarthy   11/09/2021 8:51:07 AM

The contempt we are held in by our bureaucracy is palpable.


Dr Iain   11/09/2021 11:40:37 AM

Once again general practice is considered the lowest common denominator of medicine, and our competence and objectivity to treat our patients appropriately is questioned. Presumably the TGA took their advice from other specialties. What is RACGP doing about this and other ridiculous limitations such as restrictions on requesting MRIs? I’m getting pretty tired of being the joke specialty.


Dr Ayodele Ezekiel Ogunjobi   11/09/2021 12:54:15 PM

There are 2 issues here of concerns to me: TGA-and RACGP by proxy- have accepted that GPs are inferior to other medical specialists: we are robots and can no longer be trusted to prescribe even Ivermetin- off label. This is a drug with safe profile better than any current drugs used in this pandemics. The last issues is our wrong approach to this COVID pandemics. It is a common knowledge that vaccination alone is not the only approach to manage pandemics. Being vaccinated does not make anyone a superhuman to COVID infection. If our goal is to keep Australian safe from dying, shouldn't we give alternatives to those who for whatever reasons will rather die than take the vaccines. Two or three people died in their homes in NSW recently and they were reportedly positive posthumously. India saved their nation with Ivermectin . Do we want people to die in their homes in the name of promoting vaccination? GPs should stand up for choice. I am in no way against vaccination. please.


Dr Jitendra Natverlal Parikh   11/09/2021 1:12:12 PM

Yes
I have been approached by an aggressive family twice and I obliged once which was so hard next time that I needed to call police to get rid of that patient-frustrating Indeed


Dr Michael Watson   11/09/2021 1:33:46 PM

This is good news as this means we no longer have to have this asinine conversation with patients over an unproven drug. I am disappointed however that GP's have been prescribing this when there is no evidence to support it.


Dr Sandra Jae Skinner   11/09/2021 3:12:21 PM

This is disgusting. Is medicine only about money and power now? We all know and tell our patients getting a vaccine won’t necessarily stop you getting COVID but you probably won’t get as sick. And how on earth can we back up advice such as it’s fine to give these experimental vaccines to pregnant women? Who has any idea what long term side effects will occur? One case of someone with some GIT side effects from taking a wrong dose of ivermectin, and meanwhile we’ve had a significant number of deaths and serious morbidity from these vaccines. Ivermectin is low risk, may be effective, doesn’t mean you have to stop administering vaccines, and should be available on prescription from GPs.


Dr Irene   11/09/2021 3:51:33 PM

In different part of world, practising doctors that treated covid patients have repeatedly state that early treatment safe patients from hospitalisation whether those vaccinated or non vaccinated patients. We at this moment are not treating patients and only isolate them till they worsen and went to hospital( which is late). I am surprised to see that ivermectin was unsafe drugs while doctors use it over more than 50 yrs history and has not reported kill lots of people while compare to opioids… opioids are still in market. How the organisation of people that decide what practising doctors do while they never even treated a covid patients? ( paperwork doctors) and how would a practising doctors who treated lot of covid patients would do double blinded study on patients who are sick with covid? Deny them treatment and put placebo? Or practising doctors who are reputated ICU doctors, cardiologists who treat patients early during covid infection are deem misinformative or conspiracy?


Dr Paul Jenkinson   11/09/2021 9:39:16 PM

The TGA? Are they the same people who approved a Covid vaccination for adolescent boys , a recent study from Univ of Ca has shown,has a 6 times greater chance of them being hospitalised with myocarditis after administration than being hospitalised with Covid.(which has a 99.999...% survivability in that healthy demographic)
And the TGA didn't read the fine print in the emergency use of the vaccine in pregnant women.The study supporting its use in pregnancy lasted 3 months. When I was in school, pregnancy lasted about 9 months. Any chance of longterm cognitive,behavioural or other effects in offspring.
Is informed consent even possible??
We do need an inquiry into ATAGI and TGA when all this is over.Their advice has been abysmal.


Dr Wendelin Ikarus Dietrich Fischer   12/09/2021 9:51:34 PM

Isn‘t it a bit foolish for GPs to applaude more restrictions on their independent practice of
Medicine by a group of bureaucrats?

Especially given that the jury on ivermectins effect on COVID is still out.

Additionally calling Ivermectin very dangerous sounds a bit like a joke. It is hard to find a drug thats safer to use, and has been for such a long time.


Dr Anthony Francis Dique   13/09/2021 10:07:44 AM

We should never accept such restrictions on our practice, especially ones as contentious as this. If you don't believe it's contentious then you haven't looked hard enough. I'm not aware of a single study where mortality increased with ivermectin therapy., so I'd love to see the data supporting the "it's not safe" advice. The metanalysis conducted by Prof Tess Lawrie shows about a 49 - 84% reduction in mortality. Even if you remove the disputed Elgazzar study, you're still left with a 49% reduction in mortality. So...? "is not effective in treating Covid-19" seems a little inaccurate. And what happened to the principle of autonomy? Either we as Drs are capable of determining risk vs benefit or we're not. If its the latter folks, as the TGA are now essentially asserting, then it's all over.


Dr Anthony Francis Dique   13/09/2021 11:27:07 AM

We should never accept such restrictions on our practice, especially ones as contentious as this. If you don't believe it's contentious then you haven't looked hard enough. I'm not aware of a single study where mortality increased with ivermectin therapy., so I'd love to see the data supporting the "it's not safe" advice. The metanalysis conducted by Prof Tess Lawrie shows about a 49 - 84% reduction in mortality. Even if you remove the disputed Elgazzar study, you're still left with a 49% reduction in mortality. So...? "is not effective in treating Covid-19" seems a little inaccurate. And what happened to the principle of autonomy? Either we as Drs are capable of determining risk vs benefit or we're not. If its the latter folks, as the TGA are now essentially asserting, then it's all over.


Dr Peter John Lewis   13/09/2021 3:46:27 PM

Ivermectin covid-19 studies total 114 to date (as of 13 September 2021), with 75 peer reviewed, 63 with results comparing treatment and control groups, and 31 randomised controlled trials. Of 114 studies, all but 5 reported positive results; meta-analysis of 31 RCTs found a 64% improvement for early treatment with IVM; overall 58% reduced mortality with IVM. The probability that an ineffective treatment generated results as positive as the 63 studies to date is estimated to be 1 in 1 trillion.
(c19ivermectin.com)

IVM has an excellent safety profile, adverse effects if any, are generally mild and transient, with no difference in the severity of the adverse events between standard (up to 400 μg/kg) and higher doses of ivermectin. (Safety of high-dose ivermectin: a systematic review and meta-analysis. Miriam Navarro et al. J Antimicrob Chemother 2020 Apr 1;75(4):827-834. doi: 10.1093/jac/dkz524.)


Dr Fanie Coetzee   14/09/2021 12:24:39 PM

In this article Ivermectin is wrongly painted as a dangerous drug and a "serious overdose reaction" of diarhoea is mentioned. This is laughable. Many patients taking all sorts of medications are experiencing diarhoea and a S/E. Should we remove all these meds from GP's hands then ?
The reason that there are ongoing trials on Ivermectin is the direct result of earlier use and promising observational studies from Europe, South America and India. The jury is still out.
I also think this is another example of doctors losing their freedom to practice medicine the way they see fit. There are many examples of "off label" use of medication- where do we draw the line and who should draw the line ?
We are all for evidence based medicine but we have to let the processes play themselves out on a level playing field.
And lastly; is patient autonomy still a core value in medicine and shouldn't we as doctors and the RACGP advocate for that? Looking at the poll >20 000 doctors seem to agree