PDL compounding concern
PHARMACEUTICAL Defence Limited has highlighted the ongoing evolution of compounding in Australia as representing “a particularly high regulatory concern at the present time”.
In a post published on the PDL website this week, Kellie Dell’ Oro and Tamir Katz from Meridian Lawyers urged pharmacists to make sure they are familiar with the Pharmacy Board of Australia’s (PBA’s) Guidelines on the Compounding of Medicines, which apply to both simple and complex compounding.
“Recent regulatory actions, both State and Federal, have highlighted the importance for compounding pharmacists to be aware of specific clauses in the PBA’s compounding guidelines,” the lawyers said, in particular sections which state that a compounded medicine should only be prepared when an appropriate commercial product is unavailable, where a commercial product is unsuitable (such as where a patient was allergic to an excipient in the commercial item) or when undertaking sanctioned research.
The compounding of a medicine that would be a close formulation to an available and suitable commercial product “should not take place,” they warned, noting complaints made to to AHPRA alleging unprofessional conduct where pharmacists have either been unaware of newly available commercial products or have compounded items where there has been only a slight difference between the compounded product and an equivalent commercially available product.
Recent cases have involved compounding of a testosterone cream similar to the commercially available Andro-Forte 5, as well as litigation and regulatory action around compounded medications containing phentermine, which is also commercially available as Duromine.
Variations across states and territories should also be borne in mind, the authors added - see www.pdl.org.au.