Application
This unit describes the skills and knowledge required to complete small scale compounding of sterile pharmaceutical products from pre-determined formulae, including extemporaneous dispensing. This includes cytotoxic and total parental nutrition (TPN) products.
This unit applies to pharmacy assistants and technicians working under the supervision of a pharmacist.
The skills in this unit must be applied in accordance with Commonwealth and State/Territory legislation, Australian/New Zealand standards and industry codes of practice
Elements and Performance Criteria
ELEMENT | PERFORMANCE CRITERIA |
Elements define the essential outcomes | Performance criteria describe the performance needed to demonstrate achievement of the element |
1. Source information | 1.1 Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order 1.2 Confirm suitability of chosen master work sheet and availability of resources 1.3 Obtain authority of pharmacist to proceed |
2. Prepare for production process | 2.1 Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet 2.2 Comply with dress code, safety and personal hygiene procedures prior to entering the work area 2.3 Clean work area and equipment correctly 2.4 Maintain inventory levels of materials and disposable equipment 2.5 Prepare a work sheet referenced from a 2.6 Assign product batch number 2.7 Verify that the work sheets are clearly written in logical order with clear directions and contain all the required information 2.8 Generate the product labels referenced from the master label detailed on the master work sheet 2.9 Check and note the number of labels generated 2.10 Submit work sheet and labels to pharmacist for approval 2.11 Check and set up compounding requirements and disposable equipment |
3. Obtain equipment and supplies | 3.1 Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures 3.2 Check materials to ensure they have been released from quarantine for use by authorised persons 3.3 Verify materials against manufacturing work sheet and record material batch numbers and expiry dates 3.4 Select appropriate types, size and features of containers and packaging listed in the work sheet 3.5 Weigh or measure materials in designated area 3.6 Obtain required authorisation or checks at designated points according to the work sheet |
4. Prepare for sterile manufacturing | 4.1 Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area 4.2 Follow hand washing, gowning and gloving procedures 4.3 Disinfect and transfer materials, disposable equipment and work sheet to sterile production area |
5. Prepare for cytotoxic production | 5.1 Check that cytotoxic spill cleaning kits are available in all production areas 5.2 Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required 5.3 Follow specific procedures to minimise risk of exposure to cytotoxic drugs |
6. Compound products using aseptic techniques | 6.1 Allocate approved bulk materials, intermediary products and containers to appropriate equipment 6.2 Incorporate materials according to work sheet using appropriate manipulation technique 6.3 Compound product according to method on manufacturing work sheet 6.4 Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs 6.5 Operate specialist equipment and use specialist supplies in sterile production preparation 6.6 Perform verification procedures and inspect finished product for deviations and report to authorised person 6.7 Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person 6.8 Label containers according to labelling specifications on the work sheet 6.9 Obtain required authorisation or checks at designated points |
7. Complete production process | 7.1 Reconcile the number of labels printed with number used and report discrepancies to the pharmacist 7.2 Place product in quarantine 7.3 Clean machinery and manufacturing area and dispose of disposable equipment safely 7.4 Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs 7.5 Complete required documentation and forward to an authorised person 7.6 Report discrepancies to an authorised person 7.7 Obtain final approval from pharmacist before releasing compounded medicines to storage areas 7.8 Discard waste materials appropriately |
8. Participate in quality control | 8.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet 8.2 Perform environmental monitoring and report abnormal readings to an authorised person 8.3 Submit product sample and relevant documentation to quality control 8.4 Record and file product quality control assay results and manufacturing area environmental monitoring results |
9. Store and transport released product | 9.1 Store products according to the work sheet 9.2 Obtain released product(s) from quarantine store 9.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product 9.4 Deliver product to destination ensuring safe transport of cytotoxic products 9.5 Advise receipting area personnel of storage requirements 9.6 Complete and file records and/or work sheets |
Evidence of Performance
The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:
followed established procedures and industry codes to accurately and safely produce 10 aseptic products:
worked within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet/isolators
identified issues outside scope of practice and referred these to the authorised person
Evidence of Knowledge
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
Assessment Conditions
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.
Foundation Skills
The Foundation Skills describe those required skills (language, literacy, numeracy and employment skills) that are essential to performance. |
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency. |