Elements and Performance Criteria

This range of variables provides further advice to interpret the scope and context of this unit of competence.
Work is carried out in accordance with relevant organisational policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs)

Products include the following:
Formulary drugs and non-formulary drugs e.g. clinical trial drugs and special access scheme drugs
Products with the required integrity as well as those whose integrity have been compromised, e.g. damaged, contaminated or deteriorated stock
Routine handling products and products requiring special handling, e.g. cytotoxics and its spill management, refrigerated and frozen items, light sensitive materials and flammables

Calculations may be made:
Manually
Using a calculator

Packaging/pre-packaging machine may be:
Automatic
Operated manually

Records may be kept:
Manually
Through the use of computer based systems
In print form
In an electronic system

Storage conditions may include:
Correct temperature
Humidity
Light
Secured
Ventilated
Ambient
Isolated
Correct storage of hazardous substances

Critical aspects of assessment required include:
Work is carried out in accordance with relevant organisational policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs)
Work is performed in a safe manner
Effectively package and/or pre-pack pharmaceutical products in accordance with organisational requirements
Maintain effective quality control during the packaging and/or pre-packaging process
Issues identified outside scope of practice are referred to authorised person

Relationship with other units:
This unit can be delivered and assessed independently, however holistic assessment practice with other pharmacy units of competency is encouraged.

Essential knowledge must include:
Knowledge of and the rationale for applicable legislation, organisational policy and in-house standard operating procedures (SOPs)
Basic hygiene and the importance of maintaining a clean working environment and equipment
Personal hygiene and the use of protective clothing
Various pack sizes and appropriateness
Properties of container types and principles of selection for use
Principles of calculations, weights and measures
Legal requirements and principles of pharmaceutical product labelling, e.g. product name, batch numbering and expiry date
Principles and range of storage requirements for pharmaceutical products
Identification and handling of products which include:
Formulary drugs and non-formulary drugs, e.g. clinical trial drugs and special access scheme drugs
Products with the required integrity as well as those whose integrity have been compromised, e.g. damaged, contaminated or deteriorated stock
Routine handling products and products requiring special handling, e.g. cytotoxics and its spill management, refrigerated and frozen items, light sensitive materials and flammables.

Essential skills must include:
Operate the specified equipment
Maintain packaging/pre-packing documentation
Enter and access data on pharmacy computer system
Communicate and interact appropriately with colleagues, health care practitioners, other clients and patients
Using time management strategies to set priorities
Reading and writing skills - literacy competence required to fulfil job roles in a safe manner and as specified by the organisation. The level of skill may range from the ability to understand symbols used in OHS signs, to reading and understanding manufacturers' specifications for equipment and good manufacturing practice procedures. Written documentation relating to the packing process has to be completed accurately. Literacy support available in the workplace may range from having access to support or assistance from expert/mentor/supervisor, to having no communication supports available. Literacy may be required in English or a community language.
Oral communication skills - language competence required to fulfil job roles in a safe manner and as specified by the organisation. Assessors should look for skills in asking questions, providing clear information, listening to and understanding workplace instructions, and clarifying workplace instructions when necessary. Organisations may require competence in English or a community language, depending on client group.
Numeracy skills may range from the ability to complete arithmetic calculations including percentages, weighing and measuring items to recording and collating data.
Problem solving skills required included ability to use available resources

Resource implications
Resource requirements include all the relevant resources commonly provided in the health service setting. Specific tools may include:
Relevant policies (Good Manufacturing Practice Procedures) and procedures manuals, legislation and standards
Organisation's mission statement, strategic and business plan
Other documentation relevant to the work context such as:
Organisational charts
Weighing and measuring equipment
Relevant packing machinery
Instructions for the use of equipment
Specific instructions for staff

Method of assessment
Assessment may include:
Observation of work performance
Written tasks
Interview and questioning
Authenticated portfolio/log book
Supporting statement of supervisor(s)
Authenticated evidence of relevant work experience and/or formal/informal learning

Context of assessment:
This unit is most appropriately assessed in the workplace or a simulated workplace environment under the normal range of work conditions.

Assessment should be conducted on more than one occasion to cover a variety of circumstances to establish consistency.

A diversity of assessment tasks is essential for holistic assessment.