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:
APF
MIMs
Australian medicines handbook (AMH)
Micromedex
rationale for, and key features of:
The Society of Hospital Pharmacists (SHPA) Guidelines for medicines prepared in Australian hospital pharmacy departments
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments
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 pharmaceutical products, including:
correct disposal of sharps and residues
cleaning and disinfection processes
personal hygiene
sources and types of contamination and required responses (microbial, cross-chemical, physical, environmental; and corrective strategies)
manufacturing processes relating to small scale compounding, including:
nature and use of oral and topical dosage forms
chemical and physical properties of raw materials in relation to formulation and compounding
types of equipment, their key features and use
compounding of a product according to a work sheet
principles and procedures of formulae calculations, weights and measures
processes for dilution, suspension, incorporation and reconstitution
risk considerations and procedures for pharmaceutical manufacturing:
product security
handling and storage of hazardous materials
quarantine periods
requirements for formulated manufacturing documentation
different documentation types, their scope and purpose
worksheet processes
information quality requirements including clarity, logic and completeness
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 small scale compounding