The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:
legal and ethical requirements (national, state/territory) for pharmacy work, and how these are applied in organisations, including:
codes of conduct
duty of care (and implications of negligence)
privacy, confidentiality and disclosure
records management
rights and responsibilities of workers, employers and clients
specific legislation:
medicines and their use
the practice of pharmacy
different schedules of medicines and pharmaceutical products
work role boundaries – responsibilities and limitations in manufacturing products
work health and safety
key information in standard pharmaceutical references and their use in manufacturing, including:
Australian pharmaceutical formulary and handbook (APF)
MIMs
Australian medicines handbook (AMH)
Micromedex
rationale and key features of:
The Society of Hospital Pharmacists (SHPA) Standards of practice for the safe handling of cytotoxic drugs in pharmacy departments
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)
product identification and handling, including those for:
formulary medicines and non-formulary medicines
products with the required integrity as well as those whose integrity has been compromised
routine of handling products and products requiring special handling
nature and use of different dosage forms, including:
oral
parenteral products
topical
infection control requirements for small scale compounding of aseptic pharmaceutical products, including:
aseptic technique
correct disposal of sharps and residues
cleaning and disinfection processes plus sterilisation of pharmaceuticals
personal hygiene and clothing standards
sources and types of contamination and required responses – microbial, cross-chemical, physical, environmental and corrective strategies
processes relating to aseptic, including:
calculations 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
risk considerations and procedures for pharmaceutical manufacturing:
product security
handling and storage of hazardous materials
quarantine periods
management of cytotoxic spills
specific hazards related to cytotoxic manufacture
transport of cytotoxic medications
requirements for formulated manufacturing documentation, including:
different documentation types, their scope and purpose
worksheet processes
information quality requirements (including clarity, logic and completeness)
specific labelling requirements for compounded products, including:
adherence to legislative requirements
name, form and strength of product
ancillary labels as part of label details
hazard warnings
spacing for entry of batch numbers and expiry dates
packaging methods, container materials and principles for selection
storage and transport requirements and rationale for different types of product including:
hazardous materials
special storage considerations:
humidity
isolation
light
temperature
ventilation
features and use of pharmacy systems used for aseptic compounding
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
Skills must have been demonstrated in the workplace or in a simulated environment that reflects workplace conditions. The following conditions must be met for this unit:
use of suitable facilities, equipment and resources, including:
simulated facilities with physically separate areas for preparation/checking of product, hand washing and manipulation of produce
gowns, gloves and hand washing facilities
weighing and measuring equipment
materials (including simulation medicine substitutes such as coloured water) and disposable equipment
note that a clean room environment is not required for simulated assessment
modelling of industry operating conditions, including time constraints for completing activity
Assessors must satisfy the Standards for Registered Training Organisations (RTOs) 2015/AQTF mandatory competency requirements for assessors.