The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.

Critical aspects for assessment and evidence required to demonstrate this competency unit:

The individual being assessed must provide evidence of specified essential knowledge as well as skills

Observation of workplace performance is desirable for assessment of this unit

Consistency of performance should be demonstrated over the required range of situations relevant to the workplace

Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible

Context of and specific resources for assessment:

Assessment should replicate workplace conditions as far as possible

Simulations may be used to represent workplace conditions as closely as possible
Acceptable simulation requires:

scope to determine that work is conducted within legislative and regulatory requirements

scope to determine that work is conducted within WHS and infection control requirements

Resources essential for assessment include:

access to relevant workplace or a simulated environment where assessment can take place

instructions on the use of equipment

relevant legislation, regulations and guidelines

relevant manufacturing and packing machinery

weighing and measuring equipment

Method of assessment may include:

Formal appraisal systems

Interviewing and questioning

Observation in the work place

Supporting statement of supervisor(s)

Written assignments/projects

Access and equity considerations:

All workers in the health industry should be aware of access and equity issues in relation to their own area of work

All workers should develop their ability to work in a culturally diverse environment

In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people

Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities

This describes the essential skills and knowledge and their level required for this unit.

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:

Formulated manufacturing order / master batch sheet which must:

be clearly written

be in logical order

contain all required information

contain no ambiguous information

Identification and handling of products, including:

formulary medicines and non-formulary medicines e.g. clinical trial medicines and Special Access Acheme (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. refrigerated and frozen items, light sensitive materials and flammables

Infection control principles related to small scale manufacture of pharmaceutical products including:

correct disposal of sharps, drug residues etc

hygiene and maintaining a clean working environment and equipment, including the principles of cleaning and disinfection

personal hygiene and the use of protective clothing when conducting small scale compounding pharmaceutical products

sources and types of contamination – microbial, cross-chemical, physical, environmental; and corrective strategies

Knowledge of and the rationale for The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments, 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 compounding of pharmaceutical 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

Limitations of own work role including identification and referring of issues outside scope of practice to the authorised person

Nature and use of two different dosage forms i.e. oral and topical

Work Health and Safety (WHS) policies, guidelines and symbols and their relevance to small scale compounding of pharmaceutical products

Packaging methods, container materials and principles for selection

Pharmacy or health facility computer systems related to small scale compound / manufacture of pharmaceutical products

Preparation of worksheets

Principles and practices of ethical and professional codes of conduct

Principles and procedures of maintaining security of pharmaceutical products

Principles of handling and storage of hazardous materials

Principles and procedures for implementing a quarantine period related to pharmaceutical products

Principles of manufacturing processes relating to small scale compounding, including:

chemical and physical properties of raw materials in relation to formulation and compounding

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

Principles of record keeping and required documentation to be completed

Purpose of information to be shown on medicine packs, e.g. product name, batch numbering and expiry date

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

Essential skills:

It is critical that the candidate demonstrate the ability to:

Complete and file required documentation

Correctly and safely prepare, process and manufacture quality pharmaceutical products from fixed formulae

Identify issues outside scope of practice and refer to the authorised person

Perform quality assurance monitoring

Prepare batch/work sheet and labels

Produce a product free from microbial or cross contamination

Transport and store products to meet requirements

Work in accordance with relevant work health and safety, and infection control guidelines

Work in accordance with The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments, 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 with relevant organisation policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs)

Work in accordance with relevant work health and safety, and infection control guidelines

In addition, the candidate must be able 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 the ability to:

Assemble, maintain, clean and use all equipment used in manufacturing process in the required manner and ensure a clean work environment. Cleaning methods include:

de-scaling

disinfecting

soaking

sweeping

washing

wiping

Complete manufacturing process including:

calculate medicine and other stock requirements for manufacturing

complete required documentation related to manufacturing task

compound an item according to master batch/work sheet

select and maintain appropriate equipment for manufacturing task

Take into account opportunities to address waste minimisation, environmental responsibility and sustainable practice issues

Use available resources and prioritise workload

Use literacy, numeracy and oral communication skills required to fulfil the position in a safe manner as specified by the health care facility

Use problem solving skills

The Range Statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Add any essential operating conditions that may be present with training and assessment depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts.

Information may include:

Equipment required

Packaging and label requirements

Preparation instructions

Raw drug materials list

Storage and stability data

Raw materials may include:

Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product

Therapeutic agents

Master sheet or formulae must:

Be clearly written

Be in logical order

Contain all required information

Contain no ambiguous directions

Equipment includes equipment and machinery required for manufacturing or compounding and may include:

Autoclaves

Balances

Beakers

Extractors

Filters

Gauges

Gloves

Goggles

Masks

Measures

Meters

Mixers

Needles

Ointment slabs

Pestle and mortar

Pumps

Spatulas

Stills

Syringes

Compound product may include:

Aggregation

Dissolution

Emulsification

Grinding

Mixing

Suspension

Trituration

Pack compounded product may include:

Client ready units

Bulk containers

Containers may include:

Bottles (medical and poison)

Glass jars

Miscellaneous individual client unit devices

Syringes

Tubes

Labels may be:

Electronically produced

Typed

Written

Storage conditions may include:

Ambient

Correct storage of hazardous substances

Correct temperature

Humidity

Isolated

Light

Secure and safe storage for controlled drugs

Secured

Ventilated

All required documentation may include:

Machinery and equipment records

Machinery and equipment logs

Destination may include:

Client care area

Dispensary

Store