More pharmacies are turning to compounding, but what is the true cost of business?
Ever-increasing regulatory standards for Australian compounding pharmacies
Complex compounding has evolved in Australia at an exponential speed. Not surprisingly, there has been an alarming increase in the number of cases involving complex compounding coming before pharmacy regulators. The main concern is the risk to patient safety and the lack of training and understanding of the risks faced by compounders. Due to the circumstances in which compounded medication is prepared, in order to provide immediate service to patients, full testing isn’t performed as it is for TGA registered and manufactured medicines. For this reason, pharmacists undertaking complex compounding must have strict systems, standard operating procedures and risk assessment processes to ensure best practise.
Since 2015, we have gone from having guidance on simple compounding alone, to having state and federal guidelines, professional practise standards and national framework requirements which all cover complex compounding. This year alone, both the Victorian Pharmacy Authority (VPA) & the Pharmacy Council of NSW (PCNSW) have focused energies on compounding practise in their communications and resources they provide to pharmacists. Most recently, PCNSW released their guidance on equipment and premises with an accompanying 28-page self-audit checklist. The checklist is an extensive document which ties in references to Australian standards such as the Pharmacy Board of Australia’s guidelines for compounding of medicines, the Australian Pharmaceutical Formulary & Handbook, and Pharmaceutical Society of Australia’s Professional Practise Standards.
Complex compounding is a serious high-risk undertaking, often requiring redesign of premises and considerable investment in speciality equipment, standard operating procedures, staff training and risk assessment for every compounded product dispensed. The new tools from the PCNSW although technically only applicable to NSW pharmacies, provides a clear insight into national requirements and the true investment of best practise for all Australian pharmacies.
According to the chair of the PCNSW’s Compounding Working Group, Paul Sinclair, “proprietors may find the resources informative in understanding all aspects involved” and “there is significant outlay required to deliver a compounding service.”
To comply with over 70 requirements in the 28-page checklist, which has regard to the 17 reference documents and 12 resource documents, a large investment of time and money is required. Upgrading a pharmacy from simple to complex compounding can cost a pharmacy upwards of $70,000 CAPEX alone. This covers costs such as:
• Construction of a 9m2 dedicated compounding room or adaptation of an existing space with appropriate materials.
• Separate air conditioning.
• Environmental and temperature monitoring system.
• Purchase, annual validation and maintenance of specialty equipment.
For a pharmacy compounding 20 prescriptions per week, this would take over 5 years to see any kind of return on investment.