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Evidence Guide: HLTPH306C - Package 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

 

HLTPH306C - Package pharmaceutical products

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

Prepare packing/pre packing process

  1. Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging/pre-packaging area
  2. Clean and prepare work area according to work specifications
  3. Obtain and interpret pre-packing documentation and instructions from authorised person according to packaging/pre-packaging specifications
  4. Identify, clean, prepare and set packaging/pre-packaging machinery
  5. Obtain appropriate packaging/pre-packaging materials according to stock issuing procedures
Comply with dress code, safety requirements and personal hygiene procedures prior to entering the packaging/pre-packaging area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and prepare work area according to work specifications

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain and interpret pre-packing documentation and instructions from authorised person according to packaging/pre-packaging specifications

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify, clean, prepare and set packaging/pre-packaging machinery

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain appropriate packaging/pre-packaging materials according to stock issuing procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Allocate bulk product/medicine to machinery/pre-packing apparatus

  1. Obtain and prepare approved bulk product/medicine
  2. Allocate bulk product/medicine to packaging machine/pre-packing apparatus according to instructions from an authorised person
  3. Allocate sufficient packaging/pre-packaging materials to the work area
Obtain and prepare approved bulk product/medicine

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Allocate bulk product/medicine to packaging machine/pre-packing apparatus according to instructions from an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Allocate sufficient packaging/pre-packaging materials to the work area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack or pre-pack products

  1. Initiate line opening procedures
  2. Pack or pre-pack products according to standard operating procedures
  3. Apply in-process controls and record results
  4. Report deviations to authorised person
  5. Take corrective action according to instructions from an authorised person
  6. Operate packaging machinery and equipment according to manufacturer specifications and OHS requirements
Initiate line opening procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack or pre-pack products according to standard operating procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply in-process controls and record results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report deviations to authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Take corrective action according to instructions from an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operate packaging machinery and equipment according to manufacturer specifications and OHS requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct quality control

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit sample where appropriate

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down packaging/pre-packaging process

  1. Complete packaging/pre-packaging documentation and forward according to standard operating procedures
  2. Note discrepancies in labels and documentation
  3. Reconcile number of labels printed with number used and discard excess
  4. Note and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person
  5. Alert authorised person of excess materials
  6. Clean machinery and equipment according to standard operating procedures
  7. Obtain final approval from the pharmacist before releasing packed/pre-packed medicines/product to storage areas
Complete packaging/pre-packaging documentation and forward according to standard operating procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Note discrepancies in labels and documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Reconcile number of labels printed with number used and discard excess

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Alert authorised person of excess materials

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean machinery and equipment according to standard operating procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

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 essential 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 OHS and infection control requirements

Resources essential for assessment include:

Access to relevant workplace or appropriately 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:

Observation in the work place (if possible)

Written assignments/projects, eg for fundamentals of microbiology and principles of cleaning and disinfection

Interviewing and questioning

Formal appraisal systems

Supporting statement of supervisor(s)

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:

Basic hygiene and the importance of maintaining a clean working environment and equipment

Infection control policies, guidelines and symbols and their relevance to working in a hospital pharmacy

Identification and handling of products, including

formulary drugs and non-formulary drugs eg clinical trial drugs and special access scheme drugs

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 cytotoxics and its spill management, refrigerated and frozen items, light sensitive materials and flammables

Legal requirements and principles of pharmaceutical product labelling eg product name, batch numbering and expiry date

Australia's NCCTG Guidelines for Preparation of Pharmaceuticals in Hospitals and guidelines/legislation on the filling of dose administration containers

specific labelling requirements for filling Webster style containers/dosette boxes

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

OHS policies, guidelines and symbols and their relevance to working in a hospital pharmacy

Personal hygiene and the use of protective clothing

Principles of calculations, weights and measures

Properties of container types and principles of selection for use

Storage requirements and rationale for different types of product

Various pack sizes and appropriateness

Essential skills:

It is critical that the candidate demonstrate the ability to:

Effectively package and/or pre-package products in accordance with organisation requirements

Label appropriately

Maintain effective quality control during the packaging/pre-packaging process

Refer issues identified outside scope of practice to authorised person

Work in accordance with relevant organisation policy, legislative requirements, industrial awards and agreements and in-house operating procedures (SOPs)

Work in a safe manner

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:

Enter and access data on pharmacy computer system

Maintain packaging/pre-packaging documentation

Operate the specified equipment

Take into account opportunities to address waste minimisation, environmental responsibility and sustainable practice issues

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

Use available resources and prioritise workload

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 equipment/apparatus may be operated manually or automatically and may include but are not limited to::

Scales, measures

Irons, heat sealing equipment

Tweezers

Gloves

Storage and work are conditions may include but are not limited to:

Correct temperature

Humidity, light

Security

Ventilation

Packaging materials and products may include but is not limited to:

Dosage administration aids/containers

Tamper proof dose administration containers

Webster style containers

Heat seal or press seal equipment

Durable dosette boxes

Formulary drugs and non-formulary drugs eg special access scheme drugs

Routine handling products and products requiring special handling and/or storage

Dose administration container labels may include but are not limited to:

Name of client

Pharmacy details

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

Directions for use of each medicine as prescribed

Date on which the container was filled

Products may include:

Formulary drugs and non-formulary drugs eg clinical trial drugs and special access scheme drugs

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

Routine handling products and products requiring special handling eg cytotoxics and its spill management, refrigerated and frozen items, light sensitive material and flammables