Application
This unit describes the skills and knowledge required to complete small scale compounding of non-sterile pharmaceutical products from predetermined formulae, including extemporaneous dispensing.
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 batch sheet for product, based on correct interpretation of the medication order or prescription 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 Comply with dress code, safety and personal hygiene procedures prior to entering the work area 2.2 Clean work area and equipment correctly 2.3 Confirm inventory levels of raw materials and disposable equipment 2.4 Prepare a work sheet referenced from a 2.5 Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information 2.6 Assign product batch number 2.7 Generate the product labels referenced from the master label detailed on the master work sheet 2.8 Check and note the number of labels generated 2.9 Submit work sheet and labels to pharmacist for approval 2.10 Check and set up compounding requirements and equipment |
3. Obtain equipment and supplies | 3.1 Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures 3.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons 3.3 Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates 3.4 Weigh or measure raw materials in designated area 3.5 Obtain required authorisation or checks at designated points according to work sheet |
4. Compound products | 4.1 Allocate approved raw materials to equipment according to batch work sheet 4.2 Compound product according to method on work sheet 4.3 Monitor and adjust compounding to comply with work sheet specifications 4.4 Perform verification procedures, inspect finished product for deviations and report to authorised person 4.5 Pack compounded product as specified on the work sheet, and following approval from an authorised person 4.6 Label containers/units according to labelling specifications on the work sheet 4.7 Obtain required authorisation or checks at designated points |
5. Complete production process | 5.1 Reconcile number of labels printed with number used and report discrepancies to the pharmacist 5.2 Place product in quarantine 5.3 Clean machinery and manufacturing area and dispose of disposable equipment safely 5.4 Complete all required documentation and forward to an authorised person 5.5 Report all discrepancies to an authorised person 5.6 Obtain final approval from the pharmacist before releasing packed medicines to storage areas |
6. Participate in quality control | 6.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet 6.2 Submit product sample and relevant documentation to quality control, where specified 6.3 Record and file product quality control assay results |
7. Store and transport released product | 7.1 Store products according to work sheet documentation 7.2 Obtain released product(s) from quarantine store 7.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product 7.4 Deliver product to destination 7.5 Advise receipting area personnel of specific storage requirements 7.6 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 workplace procedures and industry codes to correctly and safely compound and label at least 5 different batches of pharmaceutical products listed in the Australian pharmaceutical formulary and handbook (APF)
identified issues outside scope of own practice and referred 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:
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
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:
weighing and measuring equipment
utensils
raw materials
pharmaceutical references
modelling of industry operating conditions, including presence of time constraints for activities
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. |