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Unit of competency details

HLTPHA011 - Pack pharmaceutical products (Release 1)

Summary

Usage recommendation:
Current
Mapping:
MappingNotesDate
Supersedes HLTPHA002 - Pack pharmaceutical productsNon Equivalent. Unit code and terminology updated. Changes to performance criteria, performance evidence, knowledge evidence and assessment conditions. 24/Nov/2022

Release Status:
Current
Releases:
ReleaseRelease date
1 1 (this release) 25/Nov/2022


Classifications

SchemeCodeClassification value
ASCED Module/Unit of Competency Field of Education Identifier 089901 Purchasing, Warehousing And Distribution  

Classification history

SchemeCodeClassification valueStart dateEnd date
ASCED Module/Unit of Competency Field of Education Identifier 089901 Purchasing, Warehousing And Distribution  08/Feb/2023 
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Unit of competency

Modification History

Not applicable.

Application

This unit of competency describes the performance outcomes, skills and knowledge required to package or pre-package pharmaceutical products. This includes the repackaging of medication according to the Society of Hospital Pharmacists of Australia (SHPA) Standard of Practice in dispensing and distribution for pharmacy, national guidelines and legislation on the filling of dose administration containers.

This unit applies to hospital or health services pharmacy assistants and technicians working under the supervision of an authorised person.

The skills in this unit must be applied in accordance with Commonwealth and State or Territory legislation, Australian standards and industry codes of practice.

No occupational licensing, certification or specific legislative requirements apply to this unit at the time of publication.

Pre-requisite Unit

Nil

Competency Field

Pharmacy

Unit Sector

Health

Elements and Performance Criteria

ELEMENTS 

PERFORMANCE CRITERIA 

Elements describe the essential outcomes

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Prepare for packaging.

1.1. Comply with personal protection equipment (PPE), safety requirements and personal hygiene procedures prior to entering the packaging area.

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

1.3. Clean and prepare work area according to work sheet or equivalent documentation.

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 medication.

1.8. Prepare and check labels according to work sheet and legal requirements.

1.9. Ensure stock expiry date, batch number and other relevant stock details are correct prior to commencing pre-packs.

1.10. Submit work sheet and labels to authorised person for approval.

2. Pack products.

2.1. Use appropriate packaging equipment to pack products.

2.2. Label container or units according to labelling specifications on the work sheet.

2.3. Apply in-process controls and record results accurately.

2.4. Report deviations to an authorised person and take corrective action according to instructions from an authorised person.

3. Conduct quality control.

3.1. Obtain approval from an 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. Complete required documentation and submit sample pre-pack for quality audit.

4. Complete packaging process.

4.1. Reconcile number of labels printed with number used and report discrepancies to an authorised person.

4.2. Alert an authorised person of excess materials.

4.3. Complete batch documentation and forward according to standard operating procedures.

4.4. Obtain final approval from an authorised person before releasing packed medication or product to storage areas.

4.5. Clean equipment according to manufacturers’ instructions.

Foundation Skills

Foundation skills essential to performance are explicit in the performance criteria of this unit of competency.

Unit Mapping Information

Supersedes and is not equivalent to HLTPHA002 Pack pharmaceutical products.

Links

Companion Volume implementation guides are found in VETNet - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=ced1390f-48d9-4ab0-bd50-b015e5485705

 

Assessment requirements

Modification History

Not applicable.

Performance Evidence

Evidence of the ability to complete tasks outlined in elements and performance criteria of this unit in the context of the job role, and:

  • follow workplace procedures in terms of safe packaging and labelling practices for at least 10 different product batches, including at least 10 pre-packaged products in original packaging or decanted for different individual patients
  • reconcile labelling of product batches and complete batch documentation following workplace procedures
  • identify issues outside scope of own practice and refer to an authorised person
  • perform the activities outlined in the performance criteria of this unit during a period of at least 240 hours of work related to hospital or health services pharmacy support in a clinical workplace environment. These 240 hours may be applied collectively across all units of competency that include the requirement for workplace hours for the purposes of assessment.

Knowledge Evidence

Demonstrated knowledge required to complete the tasks outlined in elements and performance criteria of this unit:

  • National, State or Territory legal and ethical requirements 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 patients
  • specific legislation:
  • medications and their use
  • the practice of pharmacy
  • different schedules of medications and pharmaceutical products
  • work role boundaries including responsibilities and limitations
  • work health and safety
  • quality control
  • legal requirements and principles of pharmaceutical product labelling, including, 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
  • key information for inclusion
  • Pharmacy Board of Australia Guidelines for Dispensing Medicines, that apply to individual workers
  • tablet counters
  • heat sealing devices
  • use of tweezers
  • key information in standard pharmaceutical references and their use by pharmacy assistants, including:
  • Australian Pharmaceutical Formulary and Handbook (APF)
  • Monthly Index of Medical Specialities (MIMS) or AusDI Advanced
  • 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:
  • specifications
  • 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
  • hygiene
  • appropriate packaging to protect and assess products if changing container for risk of degradation including removing medications from blister packs
  • product identification and handling, including those for:
  • formulary medication and non-formulary medication
  • products with the required integrity as well as those whose integrity has been compromised
  • routine handling of products and hazardous medication including cytotoxics and teratogenics requiring special handling.

Assessment Conditions

Skills must be demonstrated in the workplace with the addition of simulations and scenarios where the full range of contexts and situations have not been provided in the workplace.

Assessment must ensure access to:

  • use of suitable facilities, equipment and resources, including:
  • measuring equipment
  • packaging equipment and materials
  • pharmaceutical stock management procedures
  • modelling of industry operating conditions, including time constraints for completing packaging activities
  • authorised person with whom to consult.

Assessors must satisfy the Standards for Registered Training Organisations’ requirements for assessors.

Links

Companion Volume implementation guides are found in VETNet - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=ced1390f-48d9-4ab0-bd50-b015e5485705