Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2019

A Good Manufacturing Practice training experience at the Princess Alexandra Hospital, Brisbane. (#100)

Marissa I Ryan 1 , Joan E Semmler 1 , Christine V Carrington 1 2
  1. Pharmacy Department, Princess Alexandra Hospital, Brisbane, QLD, Australia
  2. School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia

Background: The Sterile Production Centre (SPC) at the Princess Alexandra Hospital (PAH) is one of the few hospital-based production facilities in Queensland. Manufacturing parenteral cancer medicines is personalised and requires high precision - doses are manufactured at the individual patient level, dependent upon patient parameters and protocol. The Clinical Oncology Society of Australia (COSA) Guidelines for the Safe Prescribing, Dispensing and Administration of Systemic Cancer Therapy1 clearly outline the requirement for pharmacy staff knowledge, competence and adherence to relevant standards in order to provide safe and quality aseptic compounding of medicinal products, such as chemotherapy. Furthermore, the Pharmacy Board of Australia require pharmacy staff to undertake Continuing Professional Development (CPD) activities as part of becoming competent in complex compounding.2

Description: A perceived Good Manufacturing Practice (GMP) knowledge and competence gap in the PAH’s Cancer Pharmacy team was identified. CPD opportunities for formal GMP training are limited due to the specialised nature of the service. 

Action: Training provider SeerPharma delivered a bespoke 8 module GMP course over two days to 22 pharmacists and pharmacy technicians with varying levels of experience. Course modules included: operating and managing a clean room, environmental monitoring, and aseptic principles. Modules incorporated tests, exercises and discussions to assess understanding of course objectives.

Evaluation: Attendees completed a survey consisting of ten statements measured against a 6-point Likert scale. Results indicate increased knowledge across all module outcomes. For the majority of attendees, actual knowledge before the training was less than their perceived knowledge. 

Implications: The benefits of the GMP training course included increased GMP knowledge and competence, diversification of skill mix, and the creation of an SPC audit tool to measure compliance with GMP standards. Above all, the training contributed towards governance and expected enhanced quality and safety in the personalised delivery of sterile production services at PAH. 

  1. Carrington C, Brown-West L, Cameron K, Diakos C, Griffiths T, Kelly A, et al. COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy. Sydney: Cancer Council Australia. Available from: https://wiki.cancer.org.au/australia/COSA:Cancer_chemotherapy_medication_safety_guidelines [cited 2019 May 10]
  2. Pharmacy Board of Australia. Guidelines on compounding of medicines. 2017 Aug. Melbourne: Pharmacy Board of Australia. Available from: https://www.pharmacyboard.gov.au/Codes-Guidelines.aspx [cited 2019 Feb 13].