Preparation of pharmaceutical and advanced therapeutic products in NSW public health facilities is governed by the Policy Directive PD2023_021 Preparation of pharmaceutical and advanced therapeutic products in NSW public health facilities.
This policy directive consolidates best practice principles on the preparation, procurement, storage, transportation and waste disposal of pharmaceutical and advanced therapeutic products and provides guidance for outsourcing certain preparations. It should be used as the basis for public health facilities to develop detailed protocols and procedures specific to their local situation and circumstances.
This Policy Directive provides guidance on preparing aseptically and extemporaneously compounded pharmaceutical products and advanced therapeutic products to standards that are of a high quality and are safe. It provides guidance for outsourcing the following preparations for human use:
This policy directive does not apply to:
The local Chief Executive of a facility is responsible for the risk assessment of its current facilities.
The dispensing of compounded, aseptically prepared pharmaceutical products or advanced therapeutic products within a public health facility must not occur unless the Chief Executive has confirmed the facility has:
Where appropriate standards are not met, the Chief Executive must establish a plan of actions and procedures required to meet the minimum facility standards for the compounding or preparation of pharmaceutical and advanced therapeutic products. These must be relevant to the scope of practice of the facility, local health district, specialty health network or affiliated health organisation.
The responsibilities of the Director of Pharmacy include:
A pharmacist in a public hospital can compound a pharmaceutical product in anticipation of a medication order, under the Therapeutic Goods Regulation 1990, when the pharmaceutical medicine is required urgently and a delay in treatment is detrimental to the outcome for the patient. Compounding in anticipation of an order must be approved by the Drug and Therapeutics Committee. Where there is batch preparation, sterility testing of each batch must be performed for aseptically compounded or prepared products. Refer to the Pharmacy Board of Australia (PBA) Guidelines on Compounding of Medicines for further information on batch preparation.
NSW Health facilities undertaking aseptic compounding or preparation of pharmaceuticals and advanced therapeutic products must be compliant with the infrastructure, personnel, documentation, processes, and quality control standards described in the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010).
Non-aseptically prepared compounded products can be sourced from a community compounding pharmacy on prescription for an individual patient.
Aseptically prepared products intended to be sterile must only be sourced from a Therapeutic Goods Administration manufacturing licenced facility.
Non-aseptically prepared products follow BUDs outlined in the Australian Pharmaceutical Formulary Handbook (APF).
For aseptically prepared products without terminal sterilisation, per Section 3.1.3 Assignment of beyond use dates of PD2023_021:
The Director of Pharmacy must ensure a risk assessment is completed prior to the preparation of a pharmaceutical or advanced therapeutic product by the pharmacy service, as per the Pharmacy Board of Australia (PBA) Guidelines on Compounding of Medicines. The risk assessment must include the:
Annual accreditation is required for all clean rooms and primary engineering controls (PECs), for example powder containment cabinets or biological safety cabinets (BSCs). This accreditation must be by the National Association of Testing Authorities (NATA)
Annual calibration is required for all other equipment used in the preparation of pharmaceutical products.
Yes, primary engineering controls (PECs) must be used when preparing hazardous drugs (HDs). The choice of PEC, for example powder hood, pharmaceutical isolator, or biohazard safety cabinet, should be suitable for the HD and the level of risk identified during the risk assessment.
Annex 1 and 2 of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010) provides information on the cleaning requirements for areas where sterile and non-sterile medicinal products are prepared respectively.
No, any additions to total parenteral nutrition (TPN) must be in a positive pressure environment as per Section 3.3.4 Aseptically prepared pharmaceutical products of Policy Directive PD2023_021. Please refer to your hospital pharmacist for further advice. The nature of the TPN formulation acts as the perfect growth media for microbial proliferation. Protection of the product from microorganisms is critical to patient safety.
