2 Mar 2015

The Pharmacy Board of Australia (the Board) has released new guidelines and other tools for registered pharmacists who compound medicines.

Pharmacists who regularly compound medicines are urged to read the:

• Guidelines on compounding of medicines
• Background on the regulation of compounding by pharmacists, and
• Professional practice profile for pharmacists undertaking complex compounding.

The Guidelines on compounding of medicines were subject to wide-ranging consultation and will take effect on 28 April 2015.

The guidelines have been published now so pharmacists can become familiar with their content before implementation.

They replace Guideline 5 Extemporaneous dispensing (compounding) from the Board's Guidelines for dispensing of medicines published on 12 August 2010.

Board Chair, Adjunct Associate Professor Stephen Marty, said the intent of the new guidelines is to provide detailed guidance to pharmacists who compound medicines to ensure product quality, safety and efficacy.

Additionally, the new guidelines provide guidance on compounding medicines of a more complex nature ('complex compounding') which requires or involves specific competencies, equipment, processes and/or facilities to manage the higher risks associated with the preparation and dispensing of these medicines.

'A significant enhancement of the original guidelines, the guidance released today aims to minimise the associated risks for patients, pharmacists and other pharmacy staff,' he said.

'Improved patient outcomes and patient safety is also an aim and expectation.'

Two other tools now released are the:

1. Background on the regulation of compounding by pharmacists a.Contains information on the requirements of other authorities under their specific legislation, which relate to compounding. Each jurisdiction has separate requirements which may be specified in legislation and guidelines for these purposes.
2. Professional practice profile for pharmacists undertaking complex compounding a.Outlines the required competencies of pharmacists undertaking complex compounding. It can assist pharmacists to acquire and maintain the required competence for any type of complex compounding and can also be used by course providers to develop training programs.

The circumstances under which pharmacists may compound and supply extemporaneously prepared medicines in and from different types of premises, or require a manufacturing licence from the Therapeutic Goods Administration (TGA), can be accessed on the Therapeutic Goods Administration website.

The TGA is in the final stages of consultation about possible changes to the regulation of compounded medicines. The Board will further consider its guidance upon publication of a revised legal framework by the TGA to ensure that it is aligned with any new requirements and continues to provide protection of the public.

A meta-analysis of 52 epidemiological studies, involving a total of 21488 women with ovarian cancer, almost all from North America, Europe and Australia, was published in The Lancet on 13 February 2015 (see About the study). The findings from the study suggest that taking hormone replacement therapy (HRT) for the menopause, even for just a few years, is associated with an increased risk of developing ovarian cancer.

Comment from AMS

Dr Anna Fenton BHB, MBChB, PhD, FRACP
AMS President

"This recent meta-analysis from the Collaborative Group raises the possibility of an increased risk of ovarian cancer with use of estrogen or combined estrogen-progestogen therapy.

The data is heavily influenced by the Million Women Study which is widely acknowledged to have significant flaws. There has been no correction for the BMI of the women, their previous use of the contraceptive pill or age at menopause.

In the days since the study was released examination of the relative and absolute risk calculations have shown them to be incorrect. The revised absolute risk increase appears to now sit at just under 1 extra case per 10,000 women per year; somewhat less than the study initially suggested.  

Ovarian cancer is a rare condition but all the risks and benefits of hormone therapy need to be carefully considered when treating women at menopause.

Women should not stop hormone therapy based on this study but if they are concerned they should discuss the findings with their doctor."