Preliminary consultation on the Standard of practice for pharmacy production services

Instructions for providing feedback on the draft Standard of practice:

Download and review the DRAFT Standard of practice for pharmacy production services.
Complete the webform below and add your feedback
Submit

Consultation closes 11.59pm AEDT Sunday, 6 October 2024.

Please direct any queries about the Standard of practice consultation process to Yee Mellor, AdPha Pharmacy Standards Lead at: standards@adpha.au

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NOTES FOR THE REVIEW

This rough preliminary draft has been painstakingly authored by the Pharmacy Production Services Standard of Practice Working Group. AdPhA is seeking general and targeted feedback on ‘content’ from our members. This Standard will be further reviewed, and thoroughly edited and copyedited by AdPhA prior to submission for JPPR publication. Please feel free to ignore typographical and/or grammatical errors, and writing and referencing style at this early stage.

SECTION 1: INTRODUCTION

Comments for SECTION 1: INTRODUCTION

SECTION 2: DEFINITIONS

Question 1: Regarding the definitions for ‘preparation’ and ‘production’, do you agree the following text adequately differentiates the two terms (please provide a rationale with your feedback):

Preparation – This is an overarching term that encompasses all processes and tasks involved in production. For example, the term ‘preparation’ includes, but is not limited to, the following: aseptic production, compounding, hazardous production, receipt of materials, processing and packaging, and repackaging of products that do not require prior preparation (e.g. tablets and capsules).

Production – This includes any manipulation of the product. For example, the compounding, reconstitution, dilution and repackaging of sterile products. Production is a subset of preparation.

Question 2: Do the definitions provided in Table 1 sufficiently explain the terminology applied throughout this Standard (please include a rationale with your feedback)?

Additional comments for SECTION 2: DEFINITIONS

SECTION 3: PURPOSE AND SCOPE

Comments for SECTION 3: PURPOSE AND SCOPE

SECTION 4: OPERATION

Question 3: Regarding the determination of expiry dates for repackaged products, do you agree with the following (please include a rationale with your feedback):

Removing products from their original primary packaging, for the purpose of ‘repackaging’ invalidates the shelf-life assigned by the manufacturer. Product stability must be considered, and an appropriate expiry date assigned when products are removed from the original primary packaging and subsequently repackaged. Refer to the Expiry Dates section below for further details.

Question 4: Regarding hand hygiene, do you agree with the use of ‘hand dryers’ to ensure effective hand hygiene prior to the compounding and aseptic preparation of products (please include a rationale with your feedback)?

Question 5: Regarding the following text, should ‘minimum requirements’ for a health surveillance program be included (please include a rationale with your feedback)?

Health surveillance programs should be in place for all personnel engaged in the handling and preparation of hazardous products. Personnel must adhere and refer to national (e.g. Safe Work Australia(33)) and local occupational health and safety guidance for handling of hazardous substances and materials (e.g. vicTAG’s Handling cytotoxic agents in the workplace,(34) SafeWork NSW Cytotoxic drugs and related waste – Risk management,(35) South Australia’s Cytotoxic Drugs and Related Waste: A risk management guide for South Australian Health Services(28))

QUESTION 6: Regarding the determination of expiry dates, do you agree with the following (please include a rationale with your feedback):

When products are removed from the original primary packaging for the purpose of repackaging, the expiry date should be the manufacturer’s expiry date or one year from date of repackaging, whichever is shorter. This is dependent on the packaging used being equivalent to the manufacturer’s (e.g. type and composition of container, protection form light afforded, the inclusion of desiccant and/or oxygen absorbent packs). Products known to be adversely affected if removed from the original primary packaging (e.g. glyceryl trinitrate tablets, nicorandil tablets) must not be repackaged unless supported by validated stability studies. Products with limited in-use expiry after opening (e.g. some oral liquids, tacrolimus capsules) may be assigned an expiry no longer than the manufacturer’s recommended in-use expiry, unless longer expiry is supported by validated stability studies.

QUESTION 7: Regarding the inherently higher microbiological contamination risk of aseptically produced products intended for administration by injection, infusion, implantation or irrigation of internal cavities, do you agree with the following (please include a rationale with your feedback):

Aseptically produced products intended for administration by injection, infusion, implantation, or irrigation of internal cavities, carry an inherently higher microbiological contamination risk in comparison to aseptic products intended for topical administration (e.g. ophthalmic).

QUESTION 8: Regarding commercially procured ‘Purified Water BP’, do you agree with the following (please include a rationale with your feedback):

Water used as an ingredient for non-aseptic products must meet the standards of the British Pharmacopeia (BP) for Purified Water at the time of use. Commercially procured Purified Water BP should be freshly boiled and cooled before use. This is not necessary if Sterile Water for Irrigation BP is used within 24 hours of opening. If produced in-house, testing should occur frequently to demonstrate acceptable quality.

Additional comments for SECTION 4: OPERATION

SECTION 5: RECOMMENDED STAFFING

Comments for SECTION 5: RECOMMENDED STAFFING

SECTION 6: TRAINING, EDUCATION, AND WORKFORCE DEVELOPMENT

QUESTION 9: Regarding ‘hands-on supervised product preparation’ and ‘regular rotations in and out of the unit’, do you agree with the following (please provide a rationale with your feedback):

Production personnel must receive appropriate training and successful completion of validation procedures, followed by a minimum of 3 months full time hands-on supervised product preparation, before they can be considered fully competent and be able to work without direct supervision.

Due to the specific nature of practice, regular rotations in and out of the unit are not recommended, although the rotation of duties within the unit is encouraged. In case of absence longer than 3 months (e.g. extended leave, secondment, rotation to other duties), production personnel must receive a formal refresher, including validation, before being permitted to continue in their usual role.

Additional comments for SECTION 6: TRAINING, EDUCATION, AND WORFORCE DEVELOPMENT

SECTION 7: INNOVATION, EVALUATION AND RESEARCH

Question 10: Regarding extended expiries and the requirement to ‘replicate’ facility and equipment used in the stability test, do you agree with the following (please provide a rationale with your feedback):

Although hospital pharmacy departments usually do not perform assays for potency of active ingredients and stability testing of formulations, there are published resources and references available for formulations with stability data that allow for extended expiry dates. Incorporating extended expiries into the MFR requires replicating the ingredients, facility, and equipment used in the stability study. If published data is unavailable or when preparing batches for multiple patients with an extended expiry, stability testing becomes necessary (see [head 3] Expiry dates).