‘Inappropriate’ compounding leads to cautions, reprimands

Recent inspections have identified pharmacies carrying out complex compounding in breach of guidelines

Complex compounding is being undertaken on pharmacy premises that do not meet the requirements of guidelines, the Victorian Pharmacy Authority (VPA) has found.

In one recent case, a licensee was cautioned after complex compounding—including compounding involving the handling of hazardous substances—was undertaken at the pharmacy premises despite there being no dedicated compounding laboratory.

There was also no powder containment cabinet for operator and environment protection and a lack of suitable protective clothing.

Although the panel accepted the director of the corporate licensee’s explanation that the compounding had been undertaken by an employee pharmacist without his knowledge, including after business hours, it still cautioned the licensee.

In a second panel hearing, a licensee was reprimanded in similar circumstances, with complex compounding undertaken at the pharmacy premises without a dedicated compounding laboratory.

Expiry dates for compounded medicines were not assigned in accordance with good pharmacy practice in that creams and ointments were labelled to be discarded a number of days after opening.

The premises were not maintained in a clean and hygienic manner with respect to the compounding activities, said the VPA.

There was inadequate barcode scanning, no procedure for temperature monitoring of the drug refrigerator using a temperature data logger and deficiencies in required references.

Additionally some S8 poisons were not stored in a drug safe. These included a raw material for compounding.

In addition to being reprimanded, the licensee had a condition imposed that complex compounding is not to be undertaken at the registered premises.

The VPA says it has continued to identify cases where complex compounding is undertaken in
“inappropriate circumstances”.

It warns licensees that they are ultimately responsible for ensuring their pharmacy is meeting guidelines, and alerts them 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.

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.

“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,” says the VPA.

“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 onsupply, medicines cannot be compounded and supplied for general sale in the pharmacy.”

While some licensees have been approached by pharmacists trained in compounding and agreed to hand over responsibility to them for establishing a compounding service within the pharmacy, 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”.

“All pharmacists undertaking or considering undertaking complex compounding should thoroughly research relevant guidelines and legislation and undertake appropriate risk assessments,” it says, warning that those who breach guidelines may be referred onto the Pharmacy Board of Australia.

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