Conduct small-scale compounding and labelling of aseptic pharmaceutical products

Formats and tools

Unit Description
Reconstruct the unit from the xml and display it as an HTML page.
Assessment Tool
an assessor resource that builds a framework for writing an assessment tool
Assessment Template
generate a spreadsheet for marking this unit in a classroom environment. Put student names in the top row and check them off as they demonstrate competenece for each of the unit's elements and performance criteria.
Assessment Matrix
a slightly different format than the assessment template. A spreadsheet with unit names, elements and performance criteria in separate columns. Put assessment names in column headings to track which performance criteria each one covers. Good for ensuring that you've covered every one of the performance criteria with your assessment instrument (all assessement tools together).
Wiki Markup
mark up the unit in a wiki markup codes, ready to copy and paste into a wiki page. The output will work in most wikis but is designed to work particularly well as a Wikiversity learning project.
Evidence Guide
create an evidence guide for workplace assessment and RPL applicants
Competency Mapping Template
Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners. A template for developing assessments for a unit, which will help you to create valid, fair and reliable assessments for the unit, ready to give to trainers and students
Observation Checklist
create an observation checklist for workplace assessment and RPL applicants. This is similar to the evidence guide above, but a little shorter and friendlier on your printer. You will also need to create a seperate Assessor Marking Guide for guidelines on gathering evidence and a list of key points for each activity observed using the unit's range statement, required skills and evidence required (see the unit's html page for details)

Self Assessment Survey
A form for students to assess thier current skill levels against each of the unit's performance criteria. Cut and paste into a web document or print and distribute in hard copy.
Moodle Outcomes
Create a csv file of the unit's performance criteria to import into a moodle course as outcomes, ready to associate with each of your assignments. Here's a quick 'how to' for importing these into moodle 2.x
Registered Training Organisations
Trying to find someone to train or assess you? This link lists all the RTOs that are currently registered to deliver HLTPHA007, 'Conduct small-scale compounding and labelling of aseptic pharmaceutical products'.
Google Links
links to google searches, with filtering in place to maximise the usefulness of the returned results
Books
Reference books for 'Conduct small-scale compounding and labelling of aseptic pharmaceutical products' on fishpond.com.au. This online store has a huge range of books, pretty reasonable prices, free delivery in Australia *and* they give a small commission to ntisthis.com for every purchase, so go nuts :)


Elements and Performance Criteria

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 work sheet for the product, based on correct interpretation of the prescription or medication order

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 Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet

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

2.3 Clean work area and equipment correctly

2.4 Maintain inventory levels of materials and disposable equipment

2.5 Prepare a work sheet referenced from amaster work sheet

2.6 Assign product batch number

2.7 Verify that the work sheets are clearly written in logical order with clear directions and contain all the required information

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

2.9 Check and note the number of labels generated

2.10 Submit work sheet and labels to pharmacist for approval

2.11 Check and set up compounding requirements and disposable equipment

3. Obtain equipment and supplies

3.1 Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures

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

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

3.4 Select appropriate types, size and features of containers and packaging listed in the work sheet

3.5 Weigh or measure materials in designated area

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

4. Prepare for sterile manufacturing

4.1 Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area

4.2 Follow hand washing, gowning and gloving procedures

4.3 Disinfect and transfer materials, disposable equipment and work sheet to sterile production area

5. Prepare for cytotoxic production

5.1 Check that cytotoxic spill cleaning kits are available in all production areas

5.2 Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required

5.3 Follow specific procedures to minimise risk of exposure to cytotoxic drugs

6. Compound products using aseptic techniques

6.1 Allocate approved bulk materials, intermediary products and containers to appropriate equipment

6.2 Incorporate materials according to work sheet using appropriate manipulation technique

6.3 Compound product according to method on manufacturing work sheet

6.4 Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs

6.5 Operate specialist equipment and use specialist supplies in sterile production preparation

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

6.7 Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person

6.8 Label containers according to labelling specifications on the work sheet

6.9 Obtain required authorisation or checks at designated points

7. Complete production process

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

7.2 Place product in quarantinearea under appropriate storage conditions

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

7.4 Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs

7.5 Complete required documentation and forward to an authorised person

7.6 Report discrepancies to an authorised person

7.7 Obtain final approval from pharmacist before releasing compounded medicines to storage areas

7.8 Discard waste materials appropriately

8. Participate in quality control

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

8.2 Perform environmental monitoring and report abnormal readings to an authorised person

8.3 Submit product sample and relevant documentation to quality control

8.4 Record and file product quality control assay results and manufacturing area environmental monitoring results

9. Store and transport released product

9.1 Store products according to the work sheet

9.2 Obtain released product(s) from quarantine store

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

9.4 Deliver product to destination ensuring safe transport of cytotoxic products

9.5 Advise receipting area personnel of storage requirements

9.6 Complete and file records and/or work sheets