In February 2019, the Medical Board of Australia released a discussion paper addressing the growing concern around emerging or unconventional medicines. There has been quite a bit of discussion around the impact that this could have on compounders. Although the Medical Board of Australia does not have jurisdiction of pharmacists or pharmacies, they do have the ability to restrict practitioners and how they prescribe.
The public consultation paper is to address the use of complementary or unconventional medicines, but does make a mention of off-label use to "ensure that all areas of practise are captured". Merit must be given that they acknowledge that off-label prescribing is often necessary and unavoidable. As we know, compounding is essential in patient access to what can be live saving therapies, including those for paediatric, pregnant or palliative care patients. These indications are often not explored or registered by the owners of commercially available or "conventional medicine", being rife with ethical and monetary issues not necessarily that they are unsuitable. In these cases 'the onus is on the prescriber to defend their prescription for an indication that is not listed in the product information… if, in the opinion of the prescriber, the off-label prescription can be supported by reasonable quality evidence.’ (Day, 2013)
The mention of evidence also comes up again in the consultation paper when it directly mentions concerns with prescribing compounded products:
where a commercial product is available and suitable
where there is a lack of evidence to support the compounded product’s use
that have been manufactured in circumstances that don’t meet expected quality assurance processes
that have been manufactured in bulk rather than to meet an individual’s needs (MBA, 2019)
This list really should be a concern for anyone in the compounding industry, prescribers, patients & pharmacies alike! The Pharmacy Board of Australia's Guidelines on the compounding of medicines addresses all these points. In fact, the Medical Board and Pharmacy Board released a joint statement regarding compounding supporting it's place in practise & stressing the importance of good practice. (PBA, 2017)
According to the PBA guidelines for compounding of medicines, not only is the compounding of commercially available products explicitly forbidden, but it is also stipulates that all compounding of products needs to be done in accordance with supporting evidence. Compounding is an evidence-based medicine. It is a requirement of the PBA that pharmacists are able to justify any compounding "through … obtaining additional data and/or evidence”. (PBA, 2015). The Professional Practise Standards released by the PSA also addresses the use of evidence when compounding; to be compliant with their professional obligations, a pharmacist:
5.3.1 Confirms that all compounding activities are supported by appropriate evidence-based reference sources (e.g. published literature, relevant clinical guidance).
5.3.4 Uses appropriate evidence-based references, or advice of individuals with relevant expertise, and best-practice principles to develop or renew process documents, processes and procedures. (PSA, 2017)
The biggest question for practitioners and pharmacies is about your own pharmacy practise. What has been implemented by you to ensure you are meeting the Australian requirements and guidance of best practice? By demonstrating that you are following guidance from the PBA and PSA, pharmacists can help build confidence in the industry regardless of TGA registration. Compounding pharmacy is a science and we need to behave in such a way to demonstrate that to stakeholders by implementing clear policies & procedures, documenting correctly and communicating these values with those utilising your essential service.
So, although at first glance it seems that the consultation paper raises concerns around the use of compounded products, there is support there and if approached carefully and considerately the proposed guidance supports the use of quality, evidence-based compounded medicines as they should be done.
1. Medical Board of Australia. Public consultation on clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments Consultation paper, 2019
2. Day, R. ‘Off-label prescribing’, Australian Prescriber 36:182-3, 2013
3. Pharmacy Board of Australia. Guidelines on compounding of medicines, 2015
4. Pharmacy Board of Australia & Medical Board of Australia. Joint statement on compounded medicines, 2017
5. Pharmaceutical Society of Australia. Professional practise standards, version 5, 34-40, 2017