National Competency Standards Framework for Pharmacists in ...

Domain 5 Prepare pharmaceutical products
Standard 5.1
Standard 5.2
Standard 5.3
Standard 5.4
Consider product requirements
Prepare non-sterile drug products
Aseptically prepare sterile drug products
Prepare cytotoxic drug products
2
NOTE: Standard 5.1 underpins all of the Standards in this Domain.
Standard 5.1 must be used in conjunction with each of Standards 5.2, 5.3 and 5.4.
This Domain includes those Competency Standards required for the extemporaneous preparation of single or
multiple units of a medicine intended for immediate issue and/or use by a specific consumer. It also encompasses the
competencies required for aseptic preparation of sterile products, including those containing cytotoxic drugs.
Pharmacists are involved in preparing pharmaceutical products in a range of settings where the available equipment
and facilities may vary significantly. For example, pharmacies in public hospitals are commonly equipped with cleanroom
facilities and related consumables whereas it is uncommon for community pharmacies to have such facilities.
Most community pharmacies have some involvement in the preparation of non-sterile pharmaceutical products.
A few community pharmacies have extensive involvement in the preparation of pharmaceutical products, to the extent
that it has become an area of interest for the pharmacy.
The provision of prepared pharmaceutical products is a professional service involving the use of medication related and/or
clinical information to make professional judgements impacting on QUM. Therefore, refer also to Domain 6 Promote and
contribute to optimal use of medicines.
Where pharmacists are required to take overall responsibility for the quality, efficiency and effectiveness of compounding
services refer also to Domain 3 Leadership and management. In facilities where sterile products are prepared these
pharmacists would be expected to have a thorough knowledge of relevant Australian Standards, including those for
cleanrooms and clean workstations and cytotoxic drug safety cabinets.
The Competency Standards
Standard 5.1 Consider product requirements
Note: This standard underpins all of the standards in this Domain and is to be used in conjunction with each
of the following:
• Standard 5.2 Prepare non-sterile drug products
• Standard 5.3 Aseptically prepare sterile drug products
• Standard 5.4 Prepare cytotoxic drug products.
This Standard is concerned with the ability of pharmacists to determine the constraints that may
apply to a requested or required product (sterile and non-sterile), whether a clinical need exists
and whether suitable equipment and ingredients are available. It also covers identification of a
safe and appropriate formulation and actions to be taken on behalf of the consumer if a product
cannot be prepared.
Standard 5.1 Consider product requirements
Performance Criteria
Evidence Examples
Element 1 – Consider legislative and professional obligations
1 Understands specific codes
and regulations that apply
to the preparation of
pharmaceutical products.
2 Complies with workplace
practices and professional
conventions for product
preparation.
• Demonstrated understanding of relevant codes (e.g. Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation
Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal
Products) and legislative requirements.
• Ability to describe professional standards and conventions as well
as workplace policies and procedures for the preparation of
pharmaceutical products.
National Competency Standards Framework for Pharmacists in Australia 2010 47