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Evidence Guide: HLTPH410C - Prepare batch and work sheets and labels for compounding

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

 

HLTPH410C - Prepare batch and work sheets and labels for compounding

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

Source information on formula

  1. Select appropriate dosage form for product, based on client need and/or against application of drug
  2. Use validated resources to source available formulae for required product
  3. Consolidate and make relevant information available
  4. Confirm suitability of chosen formula and availability of resources
  5. Obtain authority of pharmacist to proceed
Select appropriate dosage form for product, based on client need and/or against application of drug

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Use validated resources to source available formulae for required product

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Consolidate and make relevant information available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm suitability of chosen formula and availability of resources

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain authority of pharmacist to proceed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Design master batch/work sheet and labels

  1. Use template to create a master batch/work sheet, if available
  2. Create a master batch/work sheet based on existing institutional format if a template is not available
  3. Verify that master batch/work sheets are clearly written in logical order with no ambiguous directions
  4. Verify that master batch/work sheets contain all the required information
  5. Create a master label that is within legislative requirements; contains name, form and strength of product; provides spacing for entry of batch numbers and expiry date and includes hazard warnings
  6. Include ancillary labels as part of label details, according to organisation policy
  7. Where specified, create batch record sheet for recording details of dates and quantities of products to be made and released for use
Use template to create a master batch/work sheet, if available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Create a master batch/work sheet based on existing institutional format if a template is not available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify that master batch/work sheets are clearly written in logical order with no ambiguous directions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify that master batch/work sheets contain all the required information

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Create a master label that is within legislative requirements; contains name, form and strength of product; provides spacing for entry of batch numbers and expiry date and includes hazard warnings

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Include ancillary labels as part of label details, according to organisation policy

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Where specified, create batch record sheet for recording details of dates and quantities of products to be made and released for use

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Seek approval and release of batch/work sheets for use

  1. Submit master batch/work sheet and labels to pharmacist for approval
  2. Once released by pharmacist, make copies of master batch/work sheet and store in designated work sheet storage file
  3. File master batch/work sheet
Submit master batch/work sheet and labels to pharmacist for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Once released by pharmacist, make copies of master batch/work sheet and store in designated work sheet storage file

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

File master batch/work sheet

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

Documents/references on pharmaceutical formulations

Instructions on the use of equipment

Method of assessment may include:

Observation in the work place (if possible)

Written assignments/projects

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

Formulation resources

Hospital or health facility in-house computer system

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

Issues of pharmaceutical procedures, relevant to formulation and calculation

Knowledge of and the rationale for applicable legislation, organisation policy and
in-house standard operating procedures (SOPs), relating to preparing batch and extemporaneous master work sheets and labels

Nature and usage of different drug dosage forms

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

Principles and procedures of maintaining security of pharmaceutical products

Principles and procedures of stock control and maintenance

Principles of good manufacturing practice as per NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals

Principles of mathematics in relation to formulation calculations

Purpose of batch numbering and expiry date on medicines

Storage requirements and rationale for different types of product

Essential skills:

It is critical that the candidate demonstrate the ability to:

Design master batch/work sheet and labels to meet organisation and legislative requirements

File master and copied documents according to organisation requirements

Refer issues identified outside scope of practice to an authorised person

Work in a safe manner

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

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

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

Use available resources and prioritise workload

Use formulation resources to prepare a master batch sheet

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 validated formulation resources to formulate a stable, pharmaceutically correct, quality product

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.

Information may include:

Raw drug materials list

Equipment required

Preparation instructions

Storage and stability data

Packaging and label requirements

Master batch/work sheets must:

Be clearly written

Be in logical order

Contain all required information

Contain no ambiguous directions

Master label must:

Be within legislative requirements

Contain name, form and strength of product

Provide spacing for entry of batch numbers and expiry dates

Include hazard warnings

Include ancillary labels as part of label details