Ivermectin: Chemists Come Between Doctor and Patient

Back in July, Health Minister Greg Hunt responded to a doctor who had been prescribing ivermectin as a prophylactic and treatment for COVID-19. The correspondence followed soon after Dr Mark Hobart was reported to the Australian Health Practitioner Regulation Agency (AHPRA) for doing likewise. After AHPRA found there was no case to answer, Mr Hunt wrote:

I acknowledge some physicians are presecribing ivermectin off-label. As you would know, the practice of prescribing medications outside of their approved indications is not regulated nor controlled by the Therapeutic Goods Administration, as it is at the discretion of the prescribing official

You can’t get much more clear than that. According to both the AHPRA and the minister, doctors have every right to recommend the cheap, off-patent drug when and as they see fit.

But not according to the Pharmaceutical Society of Australia, which has decided your local neighbourhood chemists can trump prescribing doctors if they suspect the drug is being used for other than its primary designated purpose, the treatment of roundworm parasites.

PSA recommends that pharmacists do not supply ivermectin for the treatment or prevention of COVID-19. Should pharmacists be unable to establish intended use of an ivermectin prescription, supply should be declined. — Pharmaceutical Society of Australia alert to members

That pharmacists should place themselves between doctor and patient, presuming the right to countermand a decision made a physician on the basis of suspicion alone, so outraged Phillip Altman, a veteran pharmacologist who specialises in the testing and trials of new drugs, he sent off the letter below.

Reproduced below Dr Altman’s letter is the PSA’s alert to members.

_______________________

TO: Renae Beardmore
President: Pharmaceutical Society of Australia (PSA)

I refer to the attached advice from the PSA (received 29 August 2021) on ivermectin prescribing in Australia which cannot go unanswered.

The Pharmaceutical Society of Australia is a professional organisation of Australian pharmacists. PSA is the peak national body for pharmacists, representing all of the pharmacy profession in Australia, with approximately 31,000 members.  The stated PSA mission is: “As the peak pharmacists’ body, we lead and support innovative and evidence-based healthcare service delivery by pharmacists”. 

The directive by the PSA instructs pharmacists not to supply ivermectin on prescription if they deem the prescription has been written for the management of COVID-19.  This is disturbing in that the PSA has taken upon itself, for the first time of which I am aware, to interfere with the sacred doctor-patient relationship by denying a medication, considered necessary by a doctor and legally prescribed, for a potentially serious infection.

The PSA has clearly overreached the boundary of the profession and should immediately withdraw this advice.

As a pharmacist myself, I have been proud of a profession whose members are both highly knowledgeable and eager to interface with the public to provide both valuable and easily accessible day to day health advice.  There remains a high degree of respect by the community for the service which they provide.  But this latest foray into the ideological battle regarding the management of COVID-19 brings them no credit whatsoever.

I am unsure if the PSA is unaware of the enormous weight of literature regarding the use of ivermectin in the management of COVID-19.  It would be useful for the PSA to keep abreast of the published papers regarding ivermectin which would give the PSA a better perspective (eg. Santin et al) rather than blindly accept and promulgate views without themselves interrogating the evidence.

The PSA relies on two sources upon which it has based its advice to all pharmacists.  The first is reference to a Cochrane Review and the second is reference to the current National COVID-19 Clinical Evidence Taskforce (NCCET) recommendations in relation to ivermectin. 

The Cochrane statement “At this time there is no evidence to support the use of ivermectin for treating or preventing COVID-19 infection” is incorrect.

Ivermectin has shown efficacy in the management of COVID-19 in more than 20 randomised controlled clinical trials and has been used in several successful national programs to treat the pandemic.  It is a therapeutic agent with a high therapeutic index (ie., is it a relative safe therapeutic) and highly skilled doctors around the world are using ivermectin to protect their patients from the serious consequences of COVID-19 infection and keep them out of hospital.  The body of evidence in support of ivermectin would normally be considered adequate to support a consideration for the extension of use indications for a drug like ivermectin which has been used for decades.  

The PSA needs to be aware that there are other major published reviews of the safety and efficacy of ivermectin in the literature aside from the Cochrane Review which conclude that ivermectin is a potentially safe and effective therapeutic agent for the treatment of Covid-19 (Bryant et al and Kory et al). 

The PSA also needs to be aware that the NCCET recommendations relating to ivermectin (see Quadrant article referenced below by the author of this Open Letter and the attached NCCET Commentary) have been brought into question.  The NCCET (as of this date) has failed to respond to the critical analysis of its recommendation on ivermectin.

Advice on the supply of a potentially important therapeutic agent such as ivermectin deserves more than a quick “drive-by” look at the evidence by politicians, bureaucrats and health professionals writing literature reviews of variable quality.  This is too serious.

Phillip Altman BPharm(Hons), MSc, PhD
Clinical Trial and Regulatory Affairs Consultant

Santin, AD, Scheim, DE, McCullough, PA, Yagisawa, M and Borody, TG.

Ivermectin: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19

The PSA’s letter to members, 29 August 2021

PSA is aware that some pharmacists have experienced an increase in presentations of prescriptions for ivermectin, including where the patient is unwilling or unable to discuss what they are being used for. The approved indications in Australia for ivermectin are for the treatment of roundworm infections, scabies and inflammatory rosacea.

The use of ivermectin for the treatment of COVID-19 has not been proven. The Cochrane Review published on 28 July, 2021, included that: 

There is uncertainty about the efficacy and safety of ivermectin used to treat or prevent COVID-19, although the evidence base is limited. Evaluation is continuing in 31 ongoing studies. At this time there is no evidence to support the use of ivermectin for treating or preventing COVID-19 infection.

Current Australian advice includes the following:

♦ The National COVID-19 Clinical Evidence Taskforce has issued a high priority recommendation: Do not use ivermectin for the treatment of COVID-19 outside of randomised trials with appropriate ethical approval. 

♦ Advice has also been issued by the TGA that ivermectin has not been approved in Australia (or other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.

Some doctors may decide to prescribe ivermectin for off-label use taking into account potential risks and benefits and with appropriate informed consent. However, given the lack of evidence to support use of ivermectin for COVID-19, it would be difficult for a pharmacist to professionally justify off-label supply of ivermectin outside of a well-designed clinical trial.

Therefore, PSA recommends that pharmacists do not supply ivermectin for the treatment or prevention of COVID-19. Should pharmacists be unable to establish intended use of an ivermectin prescription, supply should be declined.

As a Member of PSA, we are here to support you. If you identify unusual requests for ivermectin, please make contact so that we can pass your concerns to regulatory authorities:

• • send an email to [email protected], or 
  • call 1300 369 772, the Pharmacist to Pharmacist Advice Line exclusive to PSA Members.

References supplied to the PSA

Santin, AD, Scheim, DE, McCullough, PA, Yagisawa, M and Borody, TG.

Ivermectin: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19

Mini-Review New Microbe and New Infec. 2021; 43: 100924 (2021)

A Total Lack of Therapeutic Perspective’ – Quadrant Online.  22 Aug. 2021

Commentary on NCCET Statement on Ivermectin – Quadrant Online.  22 Aug. 2021 

Bryant, A, Lawrie, TA, Dowswell, T, Fordham, EJ, Mitchell, S, hill, SR and Tham, TC. Ivermectin for Prevention and Treatment of COVID-19 infection: A Systematic Review, Meta-analysis, and Trial Sequential Analysis to Inform Clinical Guidelines. American Journal of Therapeutics 28, e434-e460 (2021).

Kory, P, Meduri, U, Varon, J, Iglesias, J and Marik, PE. Review of the Emerging Evidence Demonstrating the Efficacy of Invermectin in the Prophylaxis and Treatment of COVID-19.   

American Journal of Therapeutics 28, e299-e318 (2021).