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 nonformulary medicines eg clinical trial medicines and Special Access Acheme SAS medicines

products with the required integrity as well as those whose integrity has been compromised eg damaged contaminated or deteriorated stock

routine handling of products and products requiring special handling eg 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 crosschemical 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 Cooperation Scheme PICS Guide to good practices for the preparation of medicinal products in healthcare establishments PE and applicable legislation organisation policy and inhouse 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 ie 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 eg 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 batchwork 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 Cooperation Scheme PICS Guide to good practices for the preparation of medicinal products in healthcare establishments PE and with relevant organisation policy legislative requirements industrial awards and agreements and inhouse 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

descaling

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 batchwork 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 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

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 supervisors

Written assignmentsprojects

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 andor Torres Strait Islander clients and communities

Information may include:

Raw materials may include:

Master sheet or formulae must:

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

Compound product may include:

Pack compounded product may include:

Containers may include:

Labels may be:

Storage conditions may include:

All required documentation may include:

Destination may include: