01.CS2.E2

• Element 2


  Implements a systematic process of preparing compounded drug products, both sterile and non-sterile, in accordance with established standards and guidelines
• PC 2.1


  The pharmacist shall comply with legal obligations and management policies associated with the preparation of pharmaceutical products.
• EVIDENCE 2.1 


  Adheres to relevant codes, legal requirements and workplace policies and procedures for the preparation of pharmaceutical products
• PC 2.2


  The pharmacist shall implement an appropriate course of action when preparation requirements cannot be met.
• EVIDENCE 2.2


  Makes rational recommendations that address the client’s/patient’s needs when the prescribed or requested product cannot be made
• PC 2.3


  The pharmacist shall maintain a register listing of all ingredients, excipients and materials
• EVIDENCE 2.3


  Refers to organized individual material safety data sheet for all applicable ingredients, excipients and materials, when necessary
• PC 2.4


  The pharmacist shall apply processes and techniques intended to secure the patient’s safety.
• EVIDENCE 2.4


  Reduces the potential for other activities and/or materials which may impede, cross contaminate or cause error in the compounding process
• PC 2.5


  The pharmacist shall follow a systematic procedure for cleaning and maintaining compounding equipment and apparatus.
• EVIDENCE 2.5

  Maintains equipment and apparatus according to manufacturers’ instructions and workplace SOPs
• PC 2.6


  The pharmacist shall follow a systematic procedure for the disposal of waste.
• EVIDENCE 2.6


  Separates hazardous waste from general waste
• PC 2.7


  The pharmacist shall maintain appropriate product records and documentation in accordance with local policies and procedures.
• EVIDENCE 2.7

  Applies a systematic process for assigning batch numbers, expiry dates and storing records of prepared products
• PC 2.8


  The pharmacist shall implement a documented procedure for complaints and recalls of dispensed compounded products.
• EVIDENCE 2.8


  Investigates errors, defects and complaints about the compounded products
• PC 2.9


  The pharmacist shall identify circumstances, which may warrant adjustments to the formulation
• EVIDENCE 2.9


  Resolves situations where a formulation requires adjustment to ensure adequate stability, compatibility and suitability for its intended use
• PC 2.10


  The pharmacist shall consult relevant and updated reference sources to modify the formulation, when necessary
• EVIDENCE 2.10


  Uses credible reference sources to correctly identify the nature and/or extent of the required adjustments
• PC 2.11


  The pharmacist shall discuss required modifications with the prescriber and/or client/patient as required.
• EVIDENCE 2.11


  Explains the required modifications with the prescriber and/or client/patien