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Evidence Guide: HLTPH307A - Pack pharmaceutical products

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

HLTPH307A - Pack pharmaceutical products

What evidence can you provide to prove your understanding of each of the following citeria?

Prepare packaging process

  1. Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area
  2. Clean and prepare work area according to batch work sheet or equivalent
  3. Obtain packaginperson and according to packaging specificationsg documentation and interpret instructions from authorised
  4. Identify, clean, prepare and set packaging equipment
  5. Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person
  6. Obtain appropriate and sufficient packaging materials according to stock issuing procedures
  7. Obtain approved medicine
  8. Prepare labels according to legal requirements
  9. Check for, and rectify, discrepancies in labels
Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and prepare work area according to batch work sheet or equivalent

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain packaginperson and according to packaging specificationsg documentation and interpret instructions from authorised

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify, clean, prepare and set packaging equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain appropriate and sufficient packaging materials according to stock issuing procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain approved medicine

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare labels according to legal requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check for, and rectify, discrepancies in labels

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack products

  1. Operate packaging equipment to pack products
  2. Attach correct label to container
  3. Apply in-process controls and record results
  4. Report deviations to authorised person and take corrective action according to instructions from an authorised person
Operate packaging equipment to pack products

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Attach correct label to container

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply in-process controls and record results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report deviations to authorised person and take corrective action according to instructions from an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct quality control

  1. Obtain approval from authorised person at designated points in the packaging process according to batch record
  2. Obtain relevant documentation and check product specifications according to batch documentation
  3. Reconcile and verify packaging materials under supervision of an authorised person
  4. Submit sample where appropriate
Obtain approval from authorised person at designated points in the packaging process according to batch record

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain relevant documentation and check product specifications according to batch documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Reconcile and verify packaging materials under supervision of an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit sample where appropriate

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete packaging process

  1. Reconcile number of labels printed with number used and report discrepancies to the pharmacist
  2. Alert authorised person of excess materials
  3. Complete packaging documentation and forwardaccording to standard operating procedures
  4. Obtain final approval from the pharmacist before releasing packed medicines/product to storage areas
  5. Clean equipment
Reconcile number of labels printed with number used and report discrepancies to the pharmacist

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Alert authorised person of excess materials

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete packaging documentation and forwardaccording to standard operating procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain final approval from the pharmacist before releasing packed medicines/product to storage areas

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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

Relevant legislation, regulations and guidelines

Weighing and measuring equipment

Relevant packing machinery

Instructions on the use of 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, eg for fundamentals of microbiology and principles of cleaning and disinfection

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

Required Skills and Knowledge

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:

Awareness of indemnity issues in relation to Commonwealth/State regulatory and legislative requirements

Identification and handling of products, including

formulary medicines and non-formulary medicines e.g. clinical trial medicines and Special Access Scheme 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. cytotoxics and their spill management, refrigerated and frozen items, light sensitive materials and flammables

Infection control principles

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

personal hygiene and the use of protective clothing when handling and packaging pharmaceutical products

Knowledge of and the rationale for applicable legislation, organisation policy and in-house standard operating procedures (SOPs), relating to packaging of pharmaceuticals

Knowledge of the legal responsibilities of providers of health care in relation to confidentiality, client rights, duty of care and implications of negligence

Legal requirements and principles of pharmaceutical product labelling e.g. product name, batch numbering and expiry date

Pharmacy Board of Australia’s Guidelines on specialised supply arrangements and guidelines/legislation on the filling of dose administration containers

specific labelling requirements for filling dose administration aids (DAAs) and other containers

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

Work Health and Safety (WHS) policies, guidelines and symbols and their relevance to packaging pharmaceutical products

Operation, cleaning and maintenance of various types of equipment, in accordance with manufacturers’ guidelines specifications and standard operating procedures, including:

counting trays

irons

heat sealing equipment

measures

scales

tweezers

Packaging principles and processes, including:

calculations, weights and measures

properties of container types and selection for use

various pack sizes and selection for use

Principles and practices of ethical and professional codes of conduct

Standard pharmaceutical references including Australian Pharmaceutical Formulary (APF), MIMs, AMH and Micromedex

Essential skills:

It is critical that the candidate demonstrate the ability to:

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

Maintain effective quality control during the packaging process

Package and label pharmaceutical products in accordance with all requirements

Work in accordance with Pharmacy Board of Australia’s Guidelines and relevant organisation policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs) for pharmaceutical product packaging including labelling

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:

Clean, operate and maintain the specified equipment according to manufacturer specifications and WHS requirements

Enter and access data on pharmacy computer system

Maintain packaging documentation

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

Range Statement

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.

Packaging process includes:

Packaging

Pre-packaging

Prepare work area includes but is not limited to checking and correcting the following:

Humidity, light

Security

Temperature

Ventilation

Packaging equipment may be operated manually or automatically and may include but is not limited to:

Counting trays

Gloves

Irons, heat sealing equipment

Scales, measures

Tweezers

Packaging materials may include but is not limited to:

Dosage administration aids/containers

Tamper proof dose administration containers

Medicines include:

Bulk products

Other medicines

Prepare labels according to legal requirements specifically for filling dose administration aids (DAA) and other containers may include but are not limited to:

Date on which the container was filled

Directions for use of each medicine as prescribed

Inclusion of ancillary labels, where required

Name of client

Name, strength, form and quantity of all medicines supplied in the container

Pharmacy details

Products may include:

Formulary medicines and non-formulary medicines e.g. clinical trial medicines and Special Access Scheme medicines

Products with the required integrity as well as those whose integrity have been compromised e.g. damaged, contaminated or deteriorated

Routine handling products and products requiring special handling e.g. cytotoxics and their spill management, refrigerated and frozen items, light sensitive material and flammables