Cautions issued to compounders who broke guidelines over replicating commercial products
The Pharmacy Board of Australia has expressed concerns about pharmacists’ breaching compounding guidelines by preparing products that are identical to available commercial products.
In its latest quarterly newsletter, the Board says it has identified examples of medicines that were compounded by pharmacists without “proper regard” to existing guidelines.
The Board says in the cases it identified, pharmacists had compounded medicines when an appropriate commercial product or was available, and/or the compounded formulation was similar to an available commercial product that was “not likely to produce a different therapeutic outcome….”
“The compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product, and would not be likely to produce a different therapeutic outcome to the commercial product, should not take place,” the Board says.
“In the case that such a medicine has been prescribed, the pharmacist should notify the prescriber that this medicine cannot be compounded under these circumstances.”
The Board said in the cases in question that involved a prescription, the pharmacists had not contacted prescribers.
Several pharmacists were cautioned in relation to their practice, the Board said, and they were advised to ensure that they comply with the Board’s compounding guidelines at all times when compounding medicines.
It reminds pharmacists that its ‘Guidelines on compounding of medicines’ state that a compounded medicine should be prepared only in circumstances where:
- an appropriate commercial product is unavailable
- a commercial product is unsuitable (e.g. if a patient experienced an allergy to an excipient in the commercial product), or
- when undertaking research sanctioned by a recognised human research ethics committee.