Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

HLTPHA002 Mapping and Delivery Guide
Pack pharmaceutical products

Version 1.0
Issue Date: April 2024


Qualification -
Unit of Competency HLTPHA002 - Pack pharmaceutical products
Description
Employability Skills
Learning Outcomes and Application This unit describes the skills and knowledge required to package or pre-package pharmaceutical products, including the repackaging of medicines according to Pharmacy Board of Australia’s Guidelines on specialised supply arrangements, national guidelines and legislation on the filling of dose administration containers.This unit applies to pharmacy assistants and technicians working under the supervision of a pharmacist.The skills in this unit must be applied in accordance with Commonwealth and State/Territory legislation, Australian/New Zealand standards and industry codes of practice.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.

Skills must be demonstrated in the workplace or in a simulated environment that reflects workplace conditions. The following conditions must be met for this unit:

use of suitable facilities, equipment and resources, including:

weighing and measuring equipment

packaging equipment and materials, including DAAs and containers

pharmaceutical stock management procedures

modelling of industry operating conditions, including time constraints for completing packaging activities

Assessors must satisfy the Standards for Registered Training Organisations (RTOs) 2015/AQTF mandatory competency requirements for assessors.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities 		Slides
PPT 		Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Elements define the essential outcomes
       
Element: Prepare for packaging
  • Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area
  • Obtain packaging documentation, work sheet and interpret instructions from authorised person and according to packaging specifications
  • Clean and prepare work area according to pre-determined work sheet or equivalent
  • Identify, clean, prepare and set packaging equipment
  • Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person
  • Obtain appropriate and sufficient packaging materials according to stock issuing procedures
  • Obtain approved medicine
  • Prepare and check labels according to work sheet and legal requirements
  • Submit work sheet and labels to pharmacist for approval
       
Element: Pack products
  • Operate packaging equipment to pack products
  • Label container/units according to labelling specifications on the work sheet
  • Apply in-process controls and record results accurately
  • Report deviations to authorised person and take corrective action according to instructions from an authorised person
       
Element: Conduct quality control
  • Obtain approval from authorised person at designated points in the packaging process according to work sheet
  • Obtain relevant quality control documentation and check product specifications according to work sheet
  • Reconcile and verify packaging materials under supervision of an authorised person
  • Submit sample
       
Element: Complete packaging process
  • Reconcile number of labels printed with number used and report discrepancies to the pharmacist
  • Alert authorised person of excess materials
  • Complete batch documentation and forwardaccording to standard operating procedures
  • Obtain final approval from the pharmacist before releasing packed medicines/product to storage areas
  • Clean equipment according to manufacturer instructions
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

ELEMENT

PERFORMANCE CRITERIA

Elements define the essential outcomes

Performance criteria describe the performance needed to demonstrate achievement of the element

1. Prepare for packaging

1.1 Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area

1.2 Obtain packaging documentation, work sheet and interpret instructions from authorised person and according to packaging specifications

1.3 Clean and prepare work area according to pre-determined work sheet or equivalent

1.4 Identify, clean, prepare and set packaging equipment

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

1.6 Obtain appropriate and sufficient packaging materials according to stock issuing procedures

1.7 Obtain approved medicine

1.8 Prepare and check labels according to work sheet and legal requirements

1.9 Submit work sheet and labels to pharmacist for approval

2. Pack products

2.1 Operate packaging equipment to pack products

2.2 Label container/units according to labelling specifications on the work sheet

2.3 Apply in-process controls and record results accurately

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

3. Conduct quality control

3.1 Obtain approval from authorised person at designated points in the packaging process according to work sheet

3.2 Obtain relevant quality control documentation and check product specifications according to work sheet

3.3 Reconcile and verify packaging materials under supervision of an authorised person

3.4 Submit sample

4. Complete packaging process

4.1 Reconcile number of labels printed with number used and report discrepancies to the pharmacist

4.2 Alert authorised person of excess materials

4.3 Complete batch documentation and forwardaccording to standard operating procedures

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

4.5 Clean equipment according to manufacturer instructions

The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:

followed workplace procedures and safe packaging practices for at least 10 different product batches, including at least 5 dose administration aids (DAAs)/dose administration containers for an individual client

identified issues outside scope of own practice and referred to the authorised person

The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:

legal and ethical requirements (national, state/territory) for pharmacy work, and how these are applied in organisations, including:

codes of conduct

duty of care (and implications of negligence)

privacy, confidentiality and disclosure

records management

rights and responsibilities of workers, employers and clients

specific legislation:

medicines and their use

the practice of pharmacy

different schedules of medicines and pharmaceutical products

work role boundaries – responsibilities and limitations

work health and safety

legal requirements and principles of pharmaceutical product labelling (product name, batch numbering and expiry date):

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

specific labelling requirements for filling DAAs and other containers

key information for inclusion:

date on which the container was filled

directions for use of each medicine according to work sheet

inclusion of ancillary labels, where required

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

pharmacy details

Pharmacy Board of Australia Guidelines for dispensing medicines, that apply to individual workers

key information in standard pharmaceutical references and their use by pharmacy assistants, including:

Australian pharmaceutical formulary and handbook (APF)

MIMs

Australian medicines handbook (AMH)

Micromedex

infection control principles and their relevance to pharmaceutical packaging

features of packaging equipment including their operation, cleaning and maintenance, 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

types of packaging materials

environmental conditions required for pharmaceutical packaging related to:

humidity, light

security

temperature

ventilation

product identification and handling, including those for:

formulary medicines and non-formulary medicines

products with the required integrity as well as those whose integrity has been compromised

routine handling of products and products requiring special handling

Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)

Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

ELEMENT

PERFORMANCE CRITERIA

Elements define the essential outcomes

Performance criteria describe the performance needed to demonstrate achievement of the element

1. Prepare for packaging

1.1 Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area

1.2 Obtain packaging documentation, work sheet and interpret instructions from authorised person and according to packaging specifications

1.3 Clean and prepare work area according to pre-determined work sheet or equivalent

1.4 Identify, clean, prepare and set packaging equipment

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

1.6 Obtain appropriate and sufficient packaging materials according to stock issuing procedures

1.7 Obtain approved medicine

1.8 Prepare and check labels according to work sheet and legal requirements

1.9 Submit work sheet and labels to pharmacist for approval

2. Pack products

2.1 Operate packaging equipment to pack products

2.2 Label container/units according to labelling specifications on the work sheet

2.3 Apply in-process controls and record results accurately

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

3. Conduct quality control

3.1 Obtain approval from authorised person at designated points in the packaging process according to work sheet

3.2 Obtain relevant quality control documentation and check product specifications according to work sheet

3.3 Reconcile and verify packaging materials under supervision of an authorised person

3.4 Submit sample

4. Complete packaging process

4.1 Reconcile number of labels printed with number used and report discrepancies to the pharmacist

4.2 Alert authorised person of excess materials

4.3 Complete batch documentation and forwardaccording to standard operating procedures

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

4.5 Clean equipment according to manufacturer instructions

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
 
Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area 
Obtain packaging documentation, work sheet and interpret instructions from authorised person and according to packaging specifications 
Clean and prepare work area according to pre-determined work sheet or equivalent 
Identify, clean, prepare and set packaging equipment 
Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person 
Obtain appropriate and sufficient packaging materials according to stock issuing procedures 
Obtain approved medicine 
Prepare and check labels according to work sheet and legal requirements 
Submit work sheet and labels to pharmacist for approval 
Operate packaging equipment to pack products 
Label container/units according to labelling specifications on the work sheet 
Apply in-process controls and record results accurately 
Report deviations to authorised person and take corrective action according to instructions from an authorised person 
Obtain approval from authorised person at designated points in the packaging process according to work sheet 
Obtain relevant quality control documentation and check product specifications according to work sheet 
Reconcile and verify packaging materials under supervision of an authorised person 
Submit sample 
Reconcile number of labels printed with number used and report discrepancies to the pharmacist 
Alert authorised person of excess materials 
Complete batch documentation and forwardaccording to standard operating procedures 
Obtain final approval from the pharmacist before releasing packed medicines/product to storage areas 
Clean equipment according to manufacturer instructions 

Forms

Assessment Cover Sheet

HLTPHA002 - Pack pharmaceutical products
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:

Assessment Record Sheet

HLTPHA002 - Pack pharmaceutical products

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: