Essential knowledge: The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role This includes knowledge of: Circumstances requiring the compounding of sterile medicine Cytotoxic medicines – their use and therapeutic effect Different types of clean rooms and laminar flow cabinets for aseptic compounding Different types of filters/compatibility of filters with pharmaceutical products Formulated manufacturing order / master batch sheet which must: be clearly written be in logical order contain all required information contain no ambiguous information Identification of the circumstances that require compounding of the product within a laminar flow hood / clean room or cytotoxic drug safety cabinet / cytotoxic suite or room or isolator Identification and handling of products, including: formulary medicines and non-formulary medicines e.g. clinical trial medicines and Special Access Scheme (SAS) medicines products with the required integrity as well as those whose integrity has been compromised e.g. damaged, contaminated or deteriorated stock routine handling of products and products requiring special handling, e.g. cytotoxics and their spill management, refrigerated and frozen items, light sensitive materials and flammables Infection control principles related to small scale manufacture of aseptic pharmaceutical products, including cytotoxic products, including: aseptic technique correct disposal of sharps, drug residues, cytotoxics etc correct use of personal protective equipment hygiene and the importance of maintaining a clean working environment and equipment, including the principles of cleaning and disinfection personal hygiene and clothing standards related to small scale manufacture of aseptic pharmaceutical products sources and types of contamination – microbial, cross-chemical, physical, environmental and corrective strategies sterilisation of pharmaceuticals Knowledge of and the rationale for The Society of Hospital Pharmacists (SHPA) Standards of Practice for the Safe Handling of Cytotoxic Drugs in Pharmacy Departments and, the Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments (PE010-3) and applicable legislation, organisation policy and in-house standard operating procedures (SOPs) relating to small scale manufacture of aseptic pharmaceutical products, including cytotoxic products Labelling requirements for compounded products, including: adherence to legislative requirements contain name, form and strength of product include ancillary labels as part of label details include hazard warnings provide spacing for entry of batch numbers and expiry dates specific labelling requirements for aseptically prepared products Nature and use of different dosage forms including: oral parenteral products i.e. intrathecal, epidural injections topical Work Health and Safety (WHS) policies, guidelines and symbols and their relevance to small scale manufacture of aseptic pharmaceutical products, including cytotoxic products including: management of cytotoxic spills principles of handling and storage of hazardous materials specific hazards related to cytotoxic manufacture transport of cytotoxic medications Packaging methods, container materials and principles for selection Pharmacy or health facility computer system related to small scale manufacture of aseptic pharmaceutical products, including cytotoxic products Preparation of worksheets Principles and practices of ethical and professional codes of conduct Principles and procedures for implementing a quarantine period related to pharmaceutical products Principles and procedures of maintaining security of pharmaceutical products Principles of manufacturing processes relating to small scale compounding of aseptic pharmaceutical products, including: calculations and content rationale for all sterile admixtures chemical and physical properties of materials in relation to formulation and compounding principles and procedures of formulae calculations, weights and measures principles of aseptic technique, including cytotoxic manufacturing processes for dilution, suspension, incorporation and reconstitution use of terminal filtration Purpose of information to be shown on medicine packs, e.g. product name, batch numbering and expiry date Principles of record keeping and required documentation to be completed Standard pharmaceutical references including Australian Pharmaceutical Formulary (APF), MIMs, AMH and Micromedex Storage requirements and rationale for different types of product including hazardous materials, special storage conditions include inflammable store, refrigeration |