Elements and Performance Criteria

This range of variables provides further advice to interpret the scope and context of this unit of competence. It assumes that 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.
Validated resources include the Australian pharmaceutical formulary, British national formulary, British Pharmacopoeia, Martindale, Trissel, hospital formulae in manual or electronic format

Dosage forms include oral (solid or liquid), parenteral and topical

Information may include:
Raw drug materials list
Equipment required
Preparation instructions
Storage and stability data
Packaging and label requirements

Master batch/work sheets must:
Be clearly written
Be in logical order
Contain all the required information
Contain no ambiguous directions

Master label must:
Be within legislative requirements;
Contain name, form and strength of product
Provide spacing for entry of batch numbers and expiry dates
Include hazard warnings
Include ancillary labels as part of label details according to institutional policy

Calculations may be made:
Manually
Using a calculator

Stock ordering may be:
Written
Verbal
Electronic

Records may be recorded:
Manually
Using computer based systems
In print form
Using 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) manner
Master batch/work sheet and labels designed to meet organisational and legislative requirements
Masters and copied documents filed in accordance with organisational requirements
Issues identified outside scope of practice are referred to authorised person
Work is performed in a safe manner

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 required includes:
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
Principles and procedures of stock control and maintenance
Principles and procedures of maintaining security of pharmaceutical products
Purpose of batch numbering and expiry date on medicines
Storage requirements and the rationale for different types of product
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
Formulation resources
Issues of pharmaceutical procedures, relevant to formulation and calculation
Nature and usage of different drug dosage forms
Principles of good manufacturing practice
Chemical and physical properties of pharmaceutical raw materials in relation to formulation and compounding
Principles of mathematics in relation to formulation calculations
Hospital or health facility in-house computer system

Underpinning skills required include:
Use validated formulation resources to formulae a stable, pharmaceutically correct, quality product
Communicate and interact appropriately with colleagues, health care practitioners, other clients and patients
Enter and access data on pharmacy computer system
Use 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 reading and writing skills is advanced and ranges from the ability to read and understand legislation, to implementing organisational policies and procedures manuals. Documentation in respect to formulation of pharmaceutical products is to be accurately completed and maintained. 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, formulation calculations, to recording, collating and analysing 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 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
Floor plans
Stock distribution
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.