Assessment Requirements for HLTPHA014 Conduct small-scale compounding and labelling of pharmaceutical products

Release: 1

Assessment Requirements for HLTPHA014 Conduct small-scale compounding and labelling of pharmaceutical products

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 and industry codes to correctly and safely compound and label at least 5 different batches of pharmaceutical products listed in the Australian Pharmaceutical Formulary and Handbook (APF)

interpret standard pharmaceutical references

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

personal protection equipment (PPE)

duty of care and implications of negligence

privacy, confidentiality and disclosure

records management

rights and responsibilities of workers, employers and patients

specific legislation:

medication and their use

the practice of pharmacy

different schedules of medication and pharmaceutical products

work role boundaries including responsibilities and limitations in compounding products

work health and safety

key information in standard pharmaceutical references and their use in compounding, including:

Australian Pharmaceutical Formulary Handbook (APF)

Monthly Index of Medical Specialities (MIMS) or AusDI Advanced

Australian Medicines Handbook (AMH)

Micromedex

rationale for, and key features of:

The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments

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 of handling products and products requiring special handling

nature and use of different dosage forms including:

oral

parenteral products

topical

infection control requirements for small scale compounding of pharmaceutical products, including:

correct disposal of sharps and residues

cleaning and disinfection processes

personal hygiene

sources and types of contamination and required responses including microbial, cross-chemical, physical, environmental and corrective strategies

compounding processes relating to small scale compounding, including:

nature and use of oral and topical dosage forms

chemical and physical properties of raw materials in relation to formulation and compounding

types of equipment, their key features and use

compounding of a product according to a work sheet

principles and procedures of formulae calculations, weights and measures

processes for dilution, suspension, incorporation and reconstitution

risk considerations and procedures for pharmaceutical compounding:

product security

handling and storage of hazardous materials

quarantine periods

requirements for formulated compounding documentation

different documentation types, their scope and purpose

worksheet processes

information quality requirements including clarity, logic and completeness

labelling requirements for compounded products, including:

adherence to legislative requirements

name, form and strength of product

ancillary labels as part of label details

hazard warnings

spacing for entry of batch numbers and expiry dates

packaging methods, container materials and principles for selection

storage and transport requirements and rationale for different types of product including:

hazardous materials

special storage considerations:

humidity

isolation

light

temperature

ventilation

features and use of pharmacy systems used for small scale compounding.

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:

weighing and measuring equipment

utensils

raw materials

pharmaceutical references

modelling of industry operating conditions, including presence of time constraints for 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