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Evidence Guide: HLTPHA002 - 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

 

HLTPHA002 - Pack pharmaceutical products

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

Elements define the essential outcomes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for packaging

  1. Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area
  2. Obtain packaging documentation, work sheet and interpret instructions from authorised person and according to packaging specifications
  3. Clean and prepare work area according to pre-determined work sheet or equivalent
  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 and check labels according to work sheet and legal requirements
  9. Submit work sheet and labels to pharmacist for approval
Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

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 and check labels according to work sheet and legal requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit work sheet and labels to pharmacist for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack products

  1. Operate packaging equipment to pack products
  2. Label container/units according to labelling specifications on the work sheet
  3. Apply in-process controls and record results accurately
  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:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply in-process controls and record results accurately

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 work sheet
  2. Obtain relevant quality control documentation and check product specifications according to work sheet
  3. Reconcile and verify packaging materials under supervision of an authorised person
  4. Submit sample
Obtain approval from authorised person at designated points in the packaging process according to work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Reconcile and verify packaging materials under supervision of an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit sample

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 batch 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 according to manufacturer instructions
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 batch 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 according to manufacturer instructions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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

Required Skills and Knowledge

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