Evohealth / Understanding Ozempic Compounding Regulations: Safeguarding Patient Safety in Pharmacy Practice

Understanding Ozempic Compounding Regulations: Safeguarding Patient Safety in Pharmacy Practice

Apr 5, 2024

Today, medicines are readily available in standard manufacturer packs and dispensed directly to patients. This has reduced the requirement for most pharmacists to compound medicines, a skill rooted in traditional pharmacy practice. However, in the past decade or so, the number of specialist pharmacies offering dedicated compounding services has grown. These pharmacies supply alternate versions of medicines, such as different flavours or modes of administration.

This week, ABC’s Four Corner program highlighted the impact of the ever-growing demand for glucagon-like-peptide1 receptor agonist analogues (GLP-1 RAs), including Ozempic® and Mounjaro®, and the subsequent scarcity of supply, leading to an increase in pharmacist-compounded versions. Regulation of these compounded medicines is facing scrutiny, and this article provides an overview of the regulatory framework including State/Territory, Federal and individual pharmacist practitioner.

1. State and Territory
Regulation of pharmacy compounding primarily falls under State and Territory Medicine and Poisons legislation. Across the country these various legislative frameworks support how, where, when and who can compound medicines. Most jurisdictions have a Chief Pharmacist who oversee this regulation and have ‘right of entry’ access to pharmacy premises.

2. Federal
At a Federal level, pharmacy compounders are exempt from obtaining a licence from the Therapeutic Goods Administration (TGA), when the compounding occurs for individual patients in small quantities. The compounded medicine is required to be prepared in the pharmacy, which is open to the public, or in a private hospital, and not a wholesale facility. Medicines supplied also do not have to be listed on the Australian Register of Therapeutic Goods (ARTG) to enable compounded supply.

3. Individual pharmacist practitioner
The Australian Health Practitioner Regulation Agency (AHPRA) oversees individual pharmacist professional conduct with the ability to place conditions, suspend or revoke registration. The Pharmacy Board, operating with AHPRA has also issued Guidelines on compounded medicines.

The varying layers of regulation have left gaps in patient safety and supply of GLP-1 RAs, as highlighted in the Four Corner’s report. To address concerns, in December 2023, the TGA issued a Safety Alert on compounding these medicines and early in 2024 initiated a targeted consultation proposing a ban on compounding by pharmacy altogether.
This approach fits within the scaffold of ‘Risk-based regulation,’ where regulatory actions align with the potential harm or risk involved. An example of a Level 1 approach might be when there is an unintentional oversight from a pharmacist or medical practitioner, that did not, or would not cause harm, resulting in an educative regulatory response. This contrasts with the situation with the GLP-1 RAs where there is potential for serious harm, thus requiring a ban on the practitioner and the activity.

This is where the TGA is now. The potential for serious harm necessitates a ban. The consultation process as described by the TGA, includes State and Territory Chief Pharmacists and AHPRA, indicates a concerted effort to amend regulatory responses to prioritise patient safety. We should expect the jurisdictions and AHPRA to move to red in their response as well.

Renae Beardmore

Managing Director, Evohealth

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