‘Extreme caution’ warranted as patients demand Ivermectin


A person with COVID-19 has overdosed on Ivermectin, as stakeholders report a spike in scripts for the treatment – and patients who won’t discuss why they want it

On Wednesday this week The Pulse, a Western Sydney health news publication, reported that a COVID-positive person had gone to the emergency department at Westmead Hospital experiencing vomiting and diarrhoea.

The symptoms were due to an overdose of Ivermectin as well as other products which purported to treat the novel coronavirus. The patient had bought these online.

“Thankfully they didn’t develop severe toxicity but it didn’t help their COVID either,” said Associate Professor Naren Gunja, a toxicologist at Westmead Hospital.

“There’s no evidence to support the use of Ivermectin to treat COVID-19.

“Don’t look for magic cures online, and don’t rely on what’s being peddled on the internet, because none of them work,” he advised the public.

The news comes as pharmacists report a jump in scripts for Ivermectin – and patient caginess about the indication, or abuse if a pharmacist declines to dispense it.

Pharmaceutical Society of Australia national president A/Prof Chris Freeman told the AJP that the recent demand for Ivermectin was “almost like déjà vu” as it mimicked previous demand for hydroxychloroquine, which has now been shown to be ineffective in treating or preventing COVID-19.

“We have had some members contact us directly and express that they have been seeing increased prescriptions from patients, either enquiring about the use of Ivermectin for the prevention or treatment of COVID-19, or actually turning up with scripts for supply of Ivermectin,” said Dr Freeman.

“Some members have explained that when they’ve gone to have a conversation around what the indication for Ivermectin was, the patient has become very defensive, and refused to continue the conversation with the pharmacist.

“When the pharmacist understands that the patient intends to use Ivermectin as a prophylactic against COVID-19, or to have on hand should they get COVID-19, and the pharmacist has tried to explain that that’s potentially inappropriate, it’s cause some confrontation with the pharmacist and the patient.”

In late August the TGA issued a statement warning that Ivermectin is not approved for the prevention or treatment of COVID-19.

It said at the time that it had detected an increase in both importation and prescribing of the medicine – later telling The Guardian that the increase in importation was tenfold.

“Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication,” the TGA said last week.

“The TGA strongly discourages self-medication and self-dosing with Ivermectin for COVID-19 as it may be dangerous to your health.

“There is insufficient evidence to validate the use of Ivermectin in patients with COVID-19.”

Ivermectin is indicated in the management and treatment of infections caused by parasites, such as mites and worms. In Australia, Ivermectin has been approved for the treatment of roundworm infections, scabies and inflammatory rosacea.

Off-label use of Ivermectin has also proven to be an issue in the United States, with the US Food and Drug Administration recently tweeting in regard to the use of veterinary preparations for COVID that, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

Dr Freeman said that some of the confrontations between patients and pharmacists over Ivermectin have become “quite aggressive”.

“We’ve had some reports of patients almost demanding that the pharmacist dispense, because the doctor has written the script,” he told the AJP.

“The advice to members is that they have a duty of care to the patient, and they also have a responsibility under our Professional Practice Standards and Code of Ethics, to ensure that the medicine being used for that patient is safe and effective. And at this point, there is not evidence to show that it’s either safe or effective in the treatment of COVID-19.”

He said that concerned pharmacists could contact the prescriber and have a conversation about the appropriateness of Ivermectin scripts.

He said that prescribers themselves may in some cases be sympathetic to “arguments put forward by people promoting these treatments,” or may have felt pressured themselves to prescribe.

A spokesperson for PDL said that, “Given that its use for treating or preventing COVID-19 is not proven and is not recommended by the TGA and NPS, PDL encourages extreme caution in dispensing or compounding ivermectin for non-approved indications, such as COVID-19”.

A spokesperson for the Pharmacy Guild of Australia told the AJP that, “The Pharmacy Guild of Australia recognises that the prescribing of medicines off-label may be necessary, but should be evidence-based and with the patient’s informed consent”.

“Prescribers have a responsibility to inform patients when a medicine is prescribed off-label and the Pharmacy Guild encourages patients to also consult with their community pharmacist on medications they are taking, to help avoid any unintended consequences; community pharmacists always have the best interests of the patient at the forefront of their services,” they said.

“It is also important that any off-label use of a medicine does not disrupt the medicine being used for its registered indications.

“In addition, the National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, is continuously updating treatment recommendations based on the best available evidence.

“They are not recommending the use of ivermectin for COVID-19 treatment outside of clinical trials with appropriate ethical approval.”

Dr Freeman warned that demand for Ivermectin for COVID-19 has had a wider impact.

“Many pharmacists are finding it hard to get hold of now, even for patients who present for appropriate reasons,” he said.

“When they try to source the Ivermectin, it becomes more and more difficult.

“We’re seeing reports of patients trying to import it from the overseas market, and of course the danger with that is that it hasn’t undergone the same rigorous process to meet Australian standards, the TGA testing for impurities and these sorts of things – so if people do take it, they’re not sure what they’re taking and the dosage might not be correct.

“We’ve also had reports of people trying to purchase Ivermectin intended for veterinary use, which comes in different formulations and different strengths, and of course reports of people overdosing and winding up in medical care because they’ve taken it inappropriately.”

He said that ultimately, many of the patients seeking Ivermectin are often feeling very anxious about the pandemic and frightened of contracting COVID-19.

“People are looking for things that might provide a sense of safety – but Ivermectin could cause them more harm.”

 

PDL members who are concerned about this issue can call the PDL helpline on 1300 854 838 to speak to a Professional Officer.

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