Recurring non-compliance: compounding warning


yellow pills in mortar with pestle for crushing medicines

The Victorian Pharmacy Authority says it continues to find cases of complex compounding being undertaken in inappropriate circumstances

The VPA highlighted the issue of complex compounding in its latest circular, reiterating its February 2019 alert to licensees about recent inspections that identified pharmacies carrying out complex compounding in breach of guidelines and/or legislative requirement.

As well as outlining some recent Panel Hearings where compounding was an issue, it highlighted that other cases have found problems such as complex compounding being undertaken in pharmacy premises that do not meet the requirements of VPA Guidelines; and compounding and supply arrangements not in accordance with the relevant exemptions in the Therapeutic Goods Regulations.

In his message to licensees, VPA chair David McConville drew particular attention to the issue.

“This Circular again draws attention to recurring non-compliance in relation to complex compounding and Schedule 8 poisons,” he writes.

“Panel hearings and meetings with licensees continue to highlight that many pharmacies do not have written policies and procedures addressing key areas, or that staff, including locums, are not aware of them.”

“The Authority has continued to find cases of complex compounding being undertaken in inappropriate circumstances,” the VPA itself warns.

It again highlighted to licensees the need to:

  • “Review all extemporaneous compounding undertaken to determine if it includes complex compounding as defined in the Pharmacy Board of Australia Guidelines on compounding of medicines [Note: this includes compounding that requires or involves special competencies, equipment, processes or facilities – examples include preparations containing hazardous ingredients (such as hormones or antibiotics) and micro-dose single-unit dosage forms. The Authority considers that in most cases the preparation of capsules will constitute complex compounding,” the VPA says.
  • “If undertaking complex compounding, ensure that the premises meet the requirements of the VPA Guidelines (a suitably equipped and enclosed laboratory is required) and that compounding is undertaken in accordance with the Pharmacy Board of Australia Guidelines on compounding of medicines.
  • “Ensure supply arrangements are in accordance with the Pharmacy Board of Australia Guidelines on compounding of medicines and therapeutic goods legislation, e.g. medicines compounded at a pharmacy cannot be supplied to another pharmacy for dispensing and on-supply, medicines cannot be compounded and supplied for general sale in the pharmacy.”

The VPA says that some licensees have been approached by pharmacists who are trained in compounding, and have agreed to hand over responsibility to these pharmacists for establishing a compounding service within the pharmacy.

However, “The Authority reminds all licensees that they are ultimately responsible for ensuring that a pharmacy is carried on in accordance with the law and good pharmacy practice,” it says.

“All pharmacists undertaking or considering undertaking complex compounding should thoroughly research relevant guidelines and legislation and undertake appropriate risk assessments.

“The Authority may refer pharmacists who breach guidelines and legislation to the Pharmacy Board of Australia.”

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