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

HLTPHA005 Mapping and Delivery Guide
Conduct small scale compounding and labelling of pharmaceutical products

Version 1.0
Issue Date: April 2024


Qualification -
Unit of Competency HLTPHA005 - Conduct small scale compounding and labelling of pharmaceutical products
Description
Employability Skills
Learning Outcomes and Application This unit describes the skills and knowledge required to complete small scale compounding of non-sterile pharmaceutical products from predetermined formulae, including extemporaneous dispensing.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 have been 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

utensils

raw materials

pharmaceutical references

modelling of industry operating conditions, including presence of time constraints for 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: Source informationon formula
  • Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription
  • Confirm suitability of chosen master work sheet and availability of resources
  • Obtain authority of pharmacist to proceed
       
Element: Prepare for production process
  • Comply with dress code, safety and personal hygiene procedures prior to entering the work area
  • Clean work area and equipment correctly
  • Confirm inventory levels of raw materials and disposable equipment
  • Prepare a work sheet referenced from amaster work sheet
  • Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information
  • Assign product batch number
  • Generate the product labels referenced from the master label detailed on the master work sheet
  • Check and note the number of labels generated
  • Submit work sheet and labels to pharmacist for approval
  • Check and set up compounding requirements and equipment
       
Element: Obtain equipment and supplies
  • Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures
  • Check raw materials to ensure they have been released from quarantine for use by authorised persons
  • Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates
  • Weigh or measure raw materials in designated area
  • Obtain required authorisation or checks at designated points according to work sheet
       
Element: Compound products
  • Allocate approved raw materials to equipment according to batch work sheet
  • Compound product according to method on work sheet
  • Monitor and adjust compounding to comply with work sheet specifications
  • Perform verification procedures, inspect finished product for deviations and report to authorised person
  • Pack compounded product as specified on the work sheet, and following approval from an authorised person
  • Label containers/units according to labelling specifications on the work sheet
  • Obtain required authorisation or checks at designated points
       
Element: Complete production process
  • Reconcile number of labels printed with number used and report discrepancies to the pharmacist
  • Place product in quarantinearea under appropriate storage conditions
  • Clean machinery and manufacturing area and dispose of disposable equipment safely
  • Complete all required documentation and forward to an authorised person
  • Report all discrepancies to an authorised person
  • Obtain final approval from the pharmacist before releasing packed medicines to storage areas
       
Element: Participate in quality control
  • Pack and label a retention sample and/or quality control sample if specified on the work sheet
  • Submit product sample and relevant documentation to quality control, where specified
  • Record and file product quality control assay results
       
Element: Store and transport released product
  • Store products according to work sheet documentation
  • Obtain released product(s) from quarantine store
  • Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
  • Deliver product to destination
  • Advise receipting area personnel of specific storage requirements
  • Complete and file records and/or work sheets
       


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. Source informationon formula

1.1 Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription

1.2 Confirm suitability of chosen master work sheet and availability of resources

1.3 Obtain authority of pharmacist to proceed

2. Prepare for production process

2.1 Comply with dress code, safety and personal hygiene procedures prior to entering the work area

2.2 Clean work area and equipment correctly

2.3 Confirm inventory levels of raw materials and disposable equipment

2.4 Prepare a work sheet referenced from amaster work sheet

2.5 Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information

2.6 Assign product batch number

2.7 Generate the product labels referenced from the master label detailed on the master work sheet

2.8 Check and note the number of labels generated

2.9 Submit work sheet and labels to pharmacist for approval

2.10 Check and set up compounding requirements and equipment

3. Obtain equipment and supplies

3.1 Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures

3.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons

3.3 Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates

3.4 Weigh or measure raw materials in designated area

3.5 Obtain required authorisation or checks at designated points according to work sheet

4. Compound products

4.1 Allocate approved raw materials to equipment according to batch work sheet

4.2 Compound product according to method on work sheet

4.3 Monitor and adjust compounding to comply with work sheet specifications

4.4 Perform verification procedures, inspect finished product for deviations and report to authorised person

4.5 Pack compounded product as specified on the work sheet, and following approval from an authorised person

4.6 Label containers/units according to labelling specifications on the work sheet

4.7 Obtain required authorisation or checks at designated points

5. Complete production process

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

5.2 Place product in quarantinearea under appropriate storage conditions

5.3 Clean machinery and manufacturing area and dispose of disposable equipment safely

5.4 Complete all required documentation and forward to an authorised person

5.5 Report all discrepancies to an authorised person

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

6. Participate in quality control

6.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet

6.2 Submit product sample and relevant documentation to quality control, where specified

6.3 Record and file product quality control assay results

7. Store and transport released product

7.1 Store products according to work sheet documentation

7.2 Obtain released product(s) from quarantine store

7.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product

7.4 Deliver product to destination

7.5 Advise receipting area personnel of specific storage requirements

7.6 Complete and file records and/or work sheets

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 industry codes to correctly and safely compound and label at least 5 different batches of pharmaceutical products listed in the Australian pharmaceutical formulary and handbook (APF)

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 in manufacturing products

work health and safety

key information in standard pharmaceutical references and their use in manufacturing, including:

APF

MIMs

Australian medicines handbook (AMH)

Micromedex

rationale for, and key features of:

The Society of Hospital Pharmacists (SHPA) Guidelines for medicines prepared in Australian hospital pharmacy departments

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments

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 of handling products and products requiring special handling

nature and use of different dosage forms including:

oral

parenteral products

topical

infection control requirements for small scale compounding of pharmaceutical products, including:

correct disposal of sharps and residues

cleaning and disinfection processes

personal hygiene

sources and types of contamination and required responses (microbial, cross-chemical, physical, environmental; and corrective strategies)

manufacturing processes relating to small scale compounding, including:

nature and use of oral and topical dosage forms

chemical and physical properties of raw materials in relation to formulation and compounding

types of equipment, their key features and use

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

risk considerations and procedures for pharmaceutical manufacturing:

product security

handling and storage of hazardous materials

quarantine periods

requirements for formulated manufacturing documentation

different documentation types, their scope and purpose

worksheet processes

information quality requirements including clarity, logic and completeness

labelling requirements for compounded products, including:

adherence to legislative requirements

name, form and strength of product

ancillary labels as part of label details

hazard warnings

spacing for entry of batch numbers and expiry dates

packaging methods, container materials and principles for selection

storage and transport requirements and rationale for different types of product including:

hazardous materials

special storage considerations:

humidity

isolation

light

temperature

ventilation

features and use of pharmacy systems used for small scale compounding

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. Source informationon formula

1.1 Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription

1.2 Confirm suitability of chosen master work sheet and availability of resources

1.3 Obtain authority of pharmacist to proceed

2. Prepare for production process

2.1 Comply with dress code, safety and personal hygiene procedures prior to entering the work area

2.2 Clean work area and equipment correctly

2.3 Confirm inventory levels of raw materials and disposable equipment

2.4 Prepare a work sheet referenced from amaster work sheet

2.5 Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information

2.6 Assign product batch number

2.7 Generate the product labels referenced from the master label detailed on the master work sheet

2.8 Check and note the number of labels generated

2.9 Submit work sheet and labels to pharmacist for approval

2.10 Check and set up compounding requirements and equipment

3. Obtain equipment and supplies

3.1 Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures

3.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons

3.3 Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates

3.4 Weigh or measure raw materials in designated area

3.5 Obtain required authorisation or checks at designated points according to work sheet

4. Compound products

4.1 Allocate approved raw materials to equipment according to batch work sheet

4.2 Compound product according to method on work sheet

4.3 Monitor and adjust compounding to comply with work sheet specifications

4.4 Perform verification procedures, inspect finished product for deviations and report to authorised person

4.5 Pack compounded product as specified on the work sheet, and following approval from an authorised person

4.6 Label containers/units according to labelling specifications on the work sheet

4.7 Obtain required authorisation or checks at designated points

5. Complete production process

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

5.2 Place product in quarantinearea under appropriate storage conditions

5.3 Clean machinery and manufacturing area and dispose of disposable equipment safely

5.4 Complete all required documentation and forward to an authorised person

5.5 Report all discrepancies to an authorised person

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

6. Participate in quality control

6.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet

6.2 Submit product sample and relevant documentation to quality control, where specified

6.3 Record and file product quality control assay results

7. Store and transport released product

7.1 Store products according to work sheet documentation

7.2 Obtain released product(s) from quarantine store

7.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product

7.4 Deliver product to destination

7.5 Advise receipting area personnel of specific storage requirements

7.6 Complete and file records and/or work sheets

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
 
Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription 
Confirm suitability of chosen master work sheet and availability of resources 
Obtain authority of pharmacist to proceed 
Comply with dress code, safety and personal hygiene procedures prior to entering the work area 
Clean work area and equipment correctly 
Confirm inventory levels of raw materials and disposable equipment 
Prepare a work sheet referenced from amaster work sheet 
Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information 
Assign product batch number 
Generate the product labels referenced from the master label detailed on the master work sheet 
Check and note the number of labels generated 
Submit work sheet and labels to pharmacist for approval 
Check and set up compounding requirements and equipment 
Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures 
Check raw materials to ensure they have been released from quarantine for use by authorised persons 
Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates 
Weigh or measure raw materials in designated area 
Obtain required authorisation or checks at designated points according to work sheet 
Allocate approved raw materials to equipment according to batch work sheet 
Compound product according to method on work sheet 
Monitor and adjust compounding to comply with work sheet specifications 
Perform verification procedures, inspect finished product for deviations and report to authorised person 
Pack compounded product as specified on the work sheet, and following approval from an authorised person 
Label containers/units according to labelling specifications on the work sheet 
Obtain required authorisation or checks at designated points 
Reconcile number of labels printed with number used and report discrepancies to the pharmacist 
Place product in quarantinearea under appropriate storage conditions 
Clean machinery and manufacturing area and dispose of disposable equipment safely 
Complete all required documentation and forward to an authorised person 
Report all discrepancies to an authorised person 
Obtain final approval from the pharmacist before releasing packed medicines to storage areas 
Pack and label a retention sample and/or quality control sample if specified on the work sheet 
Submit product sample and relevant documentation to quality control, where specified 
Record and file product quality control assay results 
Store products according to work sheet documentation 
Obtain released product(s) from quarantine store 
Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product 
Deliver product to destination 
Advise receipting area personnel of specific storage requirements 
Complete and file records and/or work sheets 

Forms

Assessment Cover Sheet

HLTPHA005 - Conduct small scale compounding and labelling of 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

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Assessor name:

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Assessment Record Sheet

HLTPHA005 - Conduct small scale compounding and labelling of 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:

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Student signature:

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