Safe handling, preparation, distribution, storage and provision of cytotoxic substances, as well as the production of sterile agents is a highly specialised area within pharmacy. Treatment and preparation of these substances hence must occur in a highly contained environment, free of any microbial contamination (such devices exist: usually a Pharmaceutical Isolator or an A-Grade Laminar Air Flow Work Station [LAFWS]). These devices control pressure and air flow within a contained area, attempting to keep preparations sterile. It is also important for the safety of the patient, nursing staff and pharmacy staff that appropriate measures are taken to minimise any chance of contamination from the agents. Ensuring such steps are adhered to requires a thorough training and validation of employees within this industry.
My course was conducted 9–13th July 2012 at the Peter MacCallum Cancer Centre (Peter Mac) in East Melbourne. The Aseptic and Cytotoxic Preparation Course is important for learning the correct conventional sterile and cytotoxic preparation techniques, and gives an insight into operational logistics at Peter Mac itself. It is, in addition, an effective and important means of validating one’s own department’s aseptic and cytotoxic policies. There were a total of four participants in the course from different states, with different knowledge backgrounds, different working environments and differing levels of exposure to the technique of maintaining sterility within an isolation device, and its associated procedures.
The course was conducted on-site at Peter Mac over five full days and is approved by the Pharmacy Board of Victoria and accredited by the Society of Hospital Pharmacists of Australia (SHPA), in accordance with their guidelines for sterile and cytotoxic preparation. A variety of topics were covered within the course, with tutorial and practical components making up the majority of the course. Some lecture topics included:
- Introduction to Cancer and Chemotherapy
- Cytotoxic Chemotherapy – An Overview
- Basis of Asepsis
- Principles of Safe Handling
- Standards of Practice
- Health Surveillance for Personnel
- Management of Cytotoxic Spills
- Working within the Cabinet
- Aseptic Techniques
- Admixture Preparation
- Technique Validation
The complete oncology technician needs to be competent in performing a broad range of duties within and outside of the cabinet, and it was pleasing that Peter Mac covered many of these concepts in sufficient detail.
Safety was also an important aspect of the course, appropriately, as it is an essential competence that we must possess.
It was beneficial to develop knowledge of isolators and LAFWS as devices for cytotoxic and aseptic handling. We were exposed to real LAFWS, first observing how they operate and then preparing ‘dummy’ products in them. Later in the week, we were validated on gowning techniques and aseptic operation in these environments. There was an appropriate integration of theory and practice, with much being learnt about fundamental needle and vial handling, and intravenous preparation.
Learning and practice was the main theme over the first three days of the course, followed by validation for the most part of the final two days. There were three separate validations, each considering and assessing different aspects of the overall ‘competent’ cytotoxic and aseptic preparation:
Approximately 45 minutes in duration and completed separately by each technician in the presence of the assessor. Three separate activities were conducted involving manipulation and transfer of fluorescein from a vial into an intravenous bag each time. At the conclusion, the assessor examined the entire cabinet as well as all products for exterior presence of fluorescein as a test of the participant’s manufacturing technique competency (fluorescein glows when examined under fluorescent light).
Approximately two hours in duration and completed independent of the assessor. Four different activities were completed using broth inside each vial and a series of manipulations were undergone, transferring the broth from one medium to another each time. The final products were submitted and incubated for two weeks, then examined for contamination. This validation was therefore an assessment of aseptic transfer and preparation technique.
Approximately 30 minutes in duration, it assessed theoretical knowledge of cytotoxics, asepsis and technique basis of knowledge.
Overall, the aseptic preparation and cytotoxic handling course was very beneficial and insightful. The course provided insight into oncology preparation and manufacture at Peter Mac, as well as validating manufacturing technique and refreshing general operations at HPS Pharmacies – Knox.
It was pleasing to confirm the techniques and overall delivery that HPS Pharmacies offer is of the highest calibre.
I thank HPS Pharmacies for the opportunity. I am confident that it will be for the company’s betterment. It will only improve an already well streamlined and proficient oncology service and hence maintain our quality working relationship with nursing staff, as well as ensuring products of the highest quality continue to be provided for patient’s chemotherapy treatment.
The course can be beneficial for future training of other new staff members and continuing education in the expanding oncology environment. This is extremely important because experience in this field is necessary, considering the potential health and occupational hazards that exist when handling, preparing and distributing cytotoxic agents. I therefore encourage anybody with any questions pertaining to preparation, handling and distribution of sterile and cytotoxic products to be in contact with your local HPS Pharmacies’ pharmacist for advice.
- SHPA Manufacturing Working Party. SHPA Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments. J Pharm Pract Res 2010; 40 (2): 133–43.