In response to recent notifications received in relation to the compounding of ivermectin for the prevention/treatment of COVID-19, the Council reminds any pharmacist involved in compounding activities of their professional obligations in respect to conducting a full risk assessment to ensure patient safety. Ivermectin is not approved for use in COVID-19. Any compounding activities should be conducted in accordance with the Pharmacy Board of Australia Guidelines on compounding of medicines.
Among other obligations, these guidelines require pharmacists to ensure that there is a strong clinical evidence base for a treatment, that an appropriate commercial product is either unavailable or unsuitable for a patient and that there is good clinical and pharmaceutical evidence to support the quality, stability (including appropriate expiry periods), safety, efficacy and rationality of any extemporaneous formulation. Given that there is strong explicit advice that the use of ivermectin for COVID 19 treatment, other than in a clinical trial, is inappropriate, such compounding of products or even dispensing commercially available ivermectin would be difficult to justify.
On Friday 10 September 2021, the Therapeutic Goods Administration (TGA) placed new restrictions on the prescribing of oral ivermectin. Subsequently, changes have been made to the NSW Poisons and Therapeutic Goods Regulation (2008) to regulate the prescribing and supply of ivermectin. Specifically, ivermectin has been added to the list of substances requiring additional authority to prescribe (clause 37) and supply (clause 52).
For pharmacists, the consequence of inclusion of ivermectin in clause 52 means that they may only supply ivermectin on the prescription of either a medical practitioner holding an authority to prescribe it, or a veterinary practitioner. On 24 September 2021, the NSW Chief Pharmacist authorised certain classes of prescribers to prescribe ivermectin. Full details can be found at on the NSW Health website; however, in summary:
- registered medical practitioners and registered nurse practitioners are only authorised to prescribe ivermectin
- in tablet form for an approved indication
- for use in approved clinical trials
- for topical use
- for use in public hospitals
- prescribing of ivermectin for a non-approved indication is restricted to medical practitioners registered in the specialities of
- gastroenterology and hepatology
- paediatric gastroenterology and hepatology
- infectious diseases
- paediatric infectious diseases
From the perspective of pharmacists, prescribers are required to indicate on the prescription that it has been issued in accordance with clause 37 of the NSW Poisons and Therapeutic Goods Regulation 2008. This indicates to the dispensing pharmacist that the prescriber has satisfied the restrictions, and the prescription is valid for dispensing. Further information is on the NSW Health website.
These changes have been introduced because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19. Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries. There are significant public health risks associated with taking ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated.
Although the TGA amendment to the Poisons Standard does not directly apply in NSW, the reasons for amending the Poisons Standard in relation to ivermectin are relevant to NSW practitioners. These reasons can be found on the public notice.