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Circular No. 26 - 21 October 2021

Circular No. 26 - 21 October 2021

In this Circular

  • Chair’s message
  • Special focus: VPA supporting the rollout of COVID-19 vaccinations in pharmacies
  • Applications: Approval of alterations to registered premises
  • Quarterly performance report
  • Did you know? Pharmacist regularly and usually in charge appointments
  • Recent panel hearings
From the inspectors

  • Compounding risk assessment
  • Am I undertaking complex compounding?
  • Can I batch compound?
  • Recent case studies

For information

  • Mobile or outreach service (off-site COVID-19 vaccination)
  • Amendment to the APF25 expiry date guidance

Resources

Chair's message

I am pleased to announce that the Authority has established a consultation program to support pharmacies in the COVID-19 vaccination rollout. VPA pharmacists are available for a virtual consultation on pharmacy premises requirements and operational matters relating to COVID-19 vaccination services including guidance on risk management. I encourage you to make an appointment with a VPA pharmacist, especially if your pharmacy is new to vaccination services.

Compounding is also a focus of this Circular with VPA inspectors stressing the importance of conducting risk assessments.

A recent panel hearing highlights that keys to the pharmacy must only be held by a registered pharmacist and that there must be no access to a pharmacy when it is not open for business if a registered pharmacist is not present.

There is also important information on the recent changes to the COVID-19 Vaccination in Community Pharmacy (CVCP) Program Rules allowing pharmacies to provide off-site COVID-19 vaccinations.

Please make the circular available to all pharmacy staff.

 

David McConville
Chair

 

Special focus

VPA supporting the rollout of COVID-19 vaccinations in pharmacies

Pharmacies play a pivotal role in the COVID-19 vaccination effort. To support this effort, VPA pharmacists are available for consultation via a virtual platform to observe the set up and operation of pharmacy premises with respect to COVID-19 vaccination and provide guidance to licensees. These sessions will not be conducted as an inspection and inspection reports will not be issued. Pharmacies will be emailed relevant resources and improvement opportunities after the session.

This consultation is a good opportunity for pharmacists in charge to clarify and ensure that their pharmacy is set up in accordance with VPA guidelines 4.3.13 Facilities for vaccination services. These guidelines have been updated to include requirements for preparing vaccines from multi-dose vials. It may be particularly beneficial to pharmacies who are relatively new to COVID-19 vaccination or vaccination services in general. The VPA may contact these pharmacies directly to offer support as well as those based in key Local Government Areas identified by the Victorian Department of Health.

Please email enquiries@pharmacy.vic.gov.au to express your interest (pharmacist name, pharmacy, and phone number) and a VPA pharmacist will be in contact to arrange a suitable time for the consultation.

Applications

Approval of alterations to registered premises

VPA inspectors have found cases of pharmacies undergoing significant alteration without VPA approval. This has resulted in a panel hearing in some cases.

As described in VPA guidelines 4.2.2 Alterations to registered premises, an application for alterations to an existing registered premises must be approved by the Authority prior to making significant alterations to a pharmacy or pharmacy department.

Significant alterations include any of the following:

  • alterations to the perimeter or perimeter security of the premises
  • alterations affecting public access to the premises
  • alterations to the dispensary including changes to the perimeter and access to the dispensary
  • addition of a compounding room or dose administration aid filling room separate to the dispensary
  • alterations to counselling areas

This list is not exhaustive. All applications are considered on a case-by-case basis. If clarification is required applicants are advised to speak to an Authority officer for advice.

The VP21 Form Application for Registration of Pharmacy Premises can be used for alterations to registered premises and is available on the Authority’s website.

Consultation rooms
If pharmacists are uncertain of whether plans for an altered or new consultation room qualifies as a significant alteration under the VPA Guidelines, they may email a proposed plan to the VPA for clarification at enquiries@pharmacy.vic.gov.au.

Quarterly performance report

The Authority's performance measurement framework provides information on its activities and intended outcomes. The quarterly performance report for the period 1 April 2021 to 30 June 2021 is available on the Authority’s website.

Did you know?

Pharmacist regularly and usually in charge appointments

The Pharmacy Regulation Act 2010 (the Act) requires the appointment of a registered pharmacist to act as the pharmacist who is regularly and usually in charge (PRUIC) of a pharmacy or pharmacy department when it is open for business.

The PRUIC has important responsibilities and obligations as described in the VPA Guidelines and the Act.

According to the VPA Guidelines:

  • The Authority is to be notified of an appointment or change in the appointment of a PRUIC.
  • If a PRUIC is absent for more than 28 days, another pharmacist is to be appointed.
  • The PRUIC may not practice as such in more than one pharmacy or pharmacy department at a time.

Proprietors may use the VP32 Form Notification of Appointment of Pharmacist in Charge available on the VPA website to notify the Authority.

Recent panel hearings

The Authority held five Panel Hearings between July and September 2021 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises. Three hearings resulted in a reprimand and two resulted in the licensee being cautioned.

A summary of a selection of hearings follows:

Case 1

The licensee allowed a dispensary assistant to access the pharmacy when it was not open for business and when a registered pharmacist was not present in breach of section 31(1) of the Act. In doing so, the licensee failed to restrict the control of keys to the pharmacy premises to registered pharmacists in accordance with Clause 3 of the Schedule to the Act. There were additional matters relating to good pharmacy practice such as cold chain management and reference texts.

The licensee was reprimanded.

Learnings

When a pharmacy or pharmacy department is closed for business, the licensee or the registered pharmacist who is regularly and usually in charge must not allow a person to have access to it unless a registered pharmacist is present.

The panel took into account a range of contributing circumstances when making its decision to issue a reprimand. If the Authority had decided to prosecute the licensee, the Act specifies a penalty of up to 60 penalty units (over $10,000) for a breach of this section.

Case 2

A pharmacist failed to lodge an application for a pharmacy business licence and obtain a licence prior to settlement of purchase of the pharmacy business. The Panel found that the pharmacist carried on a pharmacy business in breach of section 21(1)(c) of the Act as the Authority had not granted a licence to carry on a pharmacy business.

The licensee was reprimanded, the panel accepting that the failure to obtain a licence was due to an unintentinal error.

Learnings

Pharmacists must not take ownership of or commence carrying on a pharmacy business until they have been granted a licence by the Authority. To do so is a breach of the Act and significant penalties apply. The onus is on the pharmacist to comply with the Act irrespective of whether an agent was engaged to assist with the application process.

Applications should be lodged in a timely manner to allow sufficient time for a complete assessment by officers of the Authority including requests for further information. Time sensitive applications should be planned ahead of time. Where there are extenuating circumstances, the applicant may wish to contact the VPA so that it is aware of the situation.

Case 3

In this case, S8 poisons were found stored in a large cardboard box and in a garbage bag in the dispensary awaiting destruction with the licensee confirming that they had been trying to find time to work on the S8 destruction. There was a total of 68 S8 poisons identified. The existing S8 safes were occupied by the pharmacy’s current stock of S8 poisons and would not have been able to hold the S8 poisons requiring destruction. Further, the S8 poisons requiring destruction had not been recorded into the S8 register.

There were also numerous other matters identified e.g., regarding S8 management, workload, cold chain management, reference texts, vaccination, opioid replacement therapy, and dose administration aids.

The licensees were cautioned.

Learnings

All S8 poisons in the possession of the pharmacy must be stored in a lockable drug safe constructed in accordance with the Drugs, Poisons and Controlled Substances Regulations 2017. A larger drug safe or an additional drug safe must be obtained if the existing safe does not provide enough storage for all S8 poisons.

Pharmacists should take all reasonable steps to ensure any returned, unwanted or expired S8 poison is recorded in the drug register when received or identified and a subsequent record made when destroyed in accordance with regulations. This ensures that all S8 poisons in the pharmacist’s possession are accounted for and reduces the risk of misappropriation.

self-audit form is available on the Authority’s website to assist licensees and employee pharmacists to audit their compliance with key requirements of the Act, Victorian Pharmacy Authority Guidelines and good pharmacy practice.

From the inspectors

The guidance information contained in the following sections is general in nature and by no means exhaustive. If you are unsure about how particular requirements apply to your pharmacy, contact the Victorian Pharmacy Authority. Pharmacists may wish to refer to the Resources section for information on compounding matters covered in this Circular.

Compounding risk assessment

The Pharmacy Board of Australia’s Guidelines on compounding of medicines require pharmacists who compound medicines to have appropriate risk management processes in place to manage risk associated with the compounded product and the workplace. In the case of complex compounding, pharmacists are advised to document the process.

The current edition of the Australian Pharmaceutical Formulary Handbook (APF25) provides further information on risk assessment in the Compounding section. The APF25 broadly categories risk as being related to the:

  • Premises e.g. there being no powder containment cabinet for the handling of hazardous substances.
  • Product e.g. compounding formulas are not obtained from reputable sources confirming quality, stability, safety, efficacy, and rationality.
  • Personnel e.g. personal protective equipment is inadequate.
  • Patient e.g. allergy to an excipient.

The outcome of the risk assessment may include the pharmacist taking actions to effectively manage the risks or deciding not to compound that product.

The APF25 also states that additional risk assessment is required if the use of a non-pharmacopoeial formula is necessary (e.g. when making changes to an existing APF or pharmacopoeial formula). Further, pharmacists who are requested to compound medicines for which there is no published literature about safety, efficacy, pharmacokinetics, and clinical data should undertake a risk assessment to determine if it is appropriate to compound the medicine.

Pharmacists may wish to refer to the Pharmaceutical Society of Australia’s Professional Practice Standards 2017 for the compounding standard and Appendix 7 Compounding decision support and risk assessment tool.

It is not sufficient to rely on compounding formulas inherited from other pharmacists or to compound based on testimonials and impressions of peers without careful examination.

Am I undertaking complex compounding?

According to the Pharmacy Board of Australia’s Guidelines on compounding of medicines and the APF25, complex compounding requires or involves special competencies, equipment, processes and facilities to manage the higher risk associated with the preparation of these products. Pharmacies should avoid complex compounding if they are not adequately equipped.

The VPA guidelines 4.6 Pharmacies undertaking complex compounding specify requirements for complex compounding in pharmacy premises. VPA inspectors have found pharmacies undertaking complex compounding without a dedicated laboratory.

For pharmacies intending to undertake complex compounding, the addition of a compounding laboratory is considered a significant alteration and a VP21 application form should be submitted for review and approval by the Authority prior to construction.

Can I batch compound?

VPA inspectors have observed pharmacies preparing batches of compounded medicines in anticipation of receiving prescriptions or orders. This is not permitted given that exemptions allowing pharmacists to compound medicines are based on pharmacists compounding for a particular (named) person.

The Therapeutic Goods Regulations 1990 provide exemptions from the requirement to hold a manufacturing licence and to include therapeutic goods in the ARTG in particular circumstances, including:

  • when therapeutic goods (other than biologicals) are (i) produced by the pharmacist in a pharmacy where the pharmacist practices and the pharmacy is open to the public and (ii) the goods are supplied (other than by wholesale) on or from those premises; and
  • where the therapeutic goods are extemporaneously compounded by a pharmacist for a particular person for therapeutic application to that person.

Pharmacists may wish to refer to GMP information for manufacturers of compounded medicines and DAAs on the TGA website for more information regarding the exemptions.

The Pharmacy Board of Australia’s Guidelines on compounding of medicines defines batch preparation as the creation of a batch of multiple units of issue of a product. The guidelines remind pharmacists that they may only engage in batch preparation when they have a prescription or order for individually named patients for an identical compounded medicine.

The Board guidelines require the pharmacist to conduct a risk assessment before compounding a batch to consider the associated risks such as a compounding error or contamination having the potential to affect a larger number of patients and document actions taken to effectively manage the risks. The Board does not encourage batch preparation.

Recent case studies

Case studies recently published by the Pharmacy Board of Australia and the Pharmacy Council of NSW should be essential reading for compounding pharmacists. They further illustrate requirements and risks relating to complex compounding and provide useful information on lessons to be learned.

For information

Mobile or outreach service (off-Site COVID-19 vaccination)

The National COVID Vaccine Taskforce has made changes to the COVID-19 Vaccination in Community Pharmacy (CVCP) Program to enable participating community pharmacies to administer COVID-19 vaccines off-site. A full list of requirements for off-site vaccinations can be found in the revised CVCP Program Rules.

Pharmacists must also adhere to Victorian legislation for remote or outreach vaccination services as outlined in the Secretary Approval: Pharmacist Immuniser – SARS-CoV-2 (COVID-19) VACCINE and the requirements described in the Victorian Department of Health’s Victorian Pharmacist Administered Vaccination Guidelines. VPA inspectors will monitor for written policies and procedures in accordance with the department’s guidelines.

Further, pharmacists are advised to refer to the National Vaccine Storage Guidelines Strive for 5 for guidance on how to appropriately transport and monitor vaccines outside the pharmacy.

Amendment to the APF25 expiry date guidance

The Australian Pharmaceutical Formulary Handbook (APF) Editorial Board has approved an amendment to the APF25 expiry date guidance on non-sterile compounded medicines in the Good Compounding practice chapter to include the following statement:

The expiry date of compounded capsules or powders is 6 months or less from the date the medicine is compounded, provided the ingredients are stable in air and not hygroscopic or deliquescent.

Further information about the amendment can be found on the APF page of the Pharmaceutical Society of Australia website.

Resources

Supporting key learnings from recent inspections and areas of high risk, licensees and pharmacists may wish to refer to the following resources alongside the VPA Guidelines. Resources are not limited to the list below and pharmacists are encouraged to review other relevant references as required.

  • Pharmacy Board of Australia Guideline on compounding medicines here.
  • Pharmacy Board of Australia FAQ for pharmacists on the compounding of medicines here.
  • Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs here.
  • Pharmaceutical Society of Australia’s Professional Practice Standards 2017 here.
  • Current edition of the Australian Pharmaceutical Formulary Handbook.
  • Pharmacy Board of Australia Guidelines for proprietor pharmacists here.
  • Pharmacy Board of Australia Guidelines on practice-specific issues - Guideline 1 (List of reference texts for pharmacists) here.
  • Pharmacy Board of Australia Guidelines on dose administration aids and staged supply of dispensed medicines here.
  • Pharmacy Board of Australia Guidelines for dispensing of medicines with reference to requirements for barcode scanning here.
  • DPCS Regulations 2017 with reference to requirements for recording, storage and reconciliation of Schedule 8 poisons here.
  • Medicines and Poisons Regulation: Managing Schedule 8 poisons here.
  • Medicines and Poisons Regulation: Dispensing medicines here.
  • National Vaccine Storage Guidelines "Strive for 5" here.
  • Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services here.

Members of the Victorian Pharmacy Authority

Mr D McConville, Chair   (Pharmacist member)
Ms E Kennedy   (Lawyer member)
Ms C Fersterer   (Pharmacist member)
Mr B Moar   (Pharmacist member)
Ms M Ritchie   (Community member)
Mr D Sanghvi   (Pharmacist member)

Authority Staff

Registrar: Mr A Bawden
Senior Pharmacist: Mr D Thirlwall
Pharmacist: Mrs C Greco (Program Officer - Licensing and Registration)
Pharmacist: Dr J Snell (Governance and Risk Officer)
Pharmacist: Ms J Webster (Authorised Officer)
Pharmacist: Ms T To (Authorised Officer)
Pharmacist: Ms K La (Authorised Officer)
Chief Finance Officer: Mrs K Nadanakumar
Administration Officer: Mrs H Newett

Address: Level 2, 15-31 Pelham Street, Carlton, Victoria, Australia 3053
Telephone: (03) 9653 1700
Email: enquiries@pharmacy.vic.gov.au
Website: www.pharmacy.vic.gov.au

In this Circular

  • Chair’s message
  • Special focus: VPA supporting the rollout of COVID-19 vaccinations in pharmacies
  • Applications: Approval of alterations to registered premises
  • Quarterly performance report
  • Did you know? Pharmacist regularly and usually in charge appointments
  • Recent panel hearings
From the inspectors

  • Compounding risk assessment
  • Am I undertaking complex compounding?
  • Can I batch compound?
  • Recent case studies

For information

  • Mobile or outreach service (off-site COVID-19 vaccination)
  • Amendment to the APF25 expiry date guidance

Resources

Chair's message

I am pleased to announce that the Authority has established a consultation program to support pharmacies in the COVID-19 vaccination rollout. VPA pharmacists are available for a virtual consultation on pharmacy premises requirements and operational matters relating to COVID-19 vaccination services including guidance on risk management. I encourage you to make an appointment with a VPA pharmacist, especially if your pharmacy is new to vaccination services.

Compounding is also a focus of this Circular with VPA inspectors stressing the importance of conducting risk assessments.

A recent panel hearing highlights that keys to the pharmacy must only be held by a registered pharmacist and that there must be no access to a pharmacy when it is not open for business if a registered pharmacist is not present.

There is also important information on the recent changes to the COVID-19 Vaccination in Community Pharmacy (CVCP) Program Rules allowing pharmacies to provide off-site COVID-19 vaccinations.

Please make the circular available to all pharmacy staff.

 

David McConville
Chair

 

Special focus

VPA supporting the rollout of COVID-19 vaccinations in pharmacies

Pharmacies play a pivotal role in the COVID-19 vaccination effort. To support this effort, VPA pharmacists are available for consultation via a virtual platform to observe the set up and operation of pharmacy premises with respect to COVID-19 vaccination and provide guidance to licensees. These sessions will not be conducted as an inspection and inspection reports will not be issued. Pharmacies will be emailed relevant resources and improvement opportunities after the session.

This consultation is a good opportunity for pharmacists in charge to clarify and ensure that their pharmacy is set up in accordance with VPA guidelines 4.3.13 Facilities for vaccination services. These guidelines have been updated to include requirements for preparing vaccines from multi-dose vials. It may be particularly beneficial to pharmacies who are relatively new to COVID-19 vaccination or vaccination services in general. The VPA may contact these pharmacies directly to offer support as well as those based in key Local Government Areas identified by the Victorian Department of Health.

Please email enquiries@pharmacy.vic.gov.au to express your interest (pharmacist name, pharmacy, and phone number) and a VPA pharmacist will be in contact to arrange a suitable time for the consultation.

Applications

Approval of alterations to registered premises

VPA inspectors have found cases of pharmacies undergoing significant alteration without VPA approval. This has resulted in a panel hearing in some cases.

As described in VPA guidelines 4.2.2 Alterations to registered premises, an application for alterations to an existing registered premises must be approved by the Authority prior to making significant alterations to a pharmacy or pharmacy department.

Significant alterations include any of the following:

  • alterations to the perimeter or perimeter security of the premises
  • alterations affecting public access to the premises
  • alterations to the dispensary including changes to the perimeter and access to the dispensary
  • addition of a compounding room or dose administration aid filling room separate to the dispensary
  • alterations to counselling areas

This list is not exhaustive. All applications are considered on a case-by-case basis. If clarification is required applicants are advised to speak to an Authority officer for advice.

The VP21 Form Application for Registration of Pharmacy Premises can be used for alterations to registered premises and is available on the Authority’s website.

Consultation rooms
If pharmacists are uncertain of whether plans for an altered or new consultation room qualifies as a significant alteration under the VPA Guidelines, they may email a proposed plan to the VPA for clarification at enquiries@pharmacy.vic.gov.au.

Quarterly performance report

The Authority's performance measurement framework provides information on its activities and intended outcomes. The quarterly performance report for the period 1 April 2021 to 30 June 2021 is available on the Authority’s website.

Did you know?

Pharmacist regularly and usually in charge appointments

The Pharmacy Regulation Act 2010 (the Act) requires the appointment of a registered pharmacist to act as the pharmacist who is regularly and usually in charge (PRUIC) of a pharmacy or pharmacy department when it is open for business.

The PRUIC has important responsibilities and obligations as described in the VPA Guidelines and the Act.

According to the VPA Guidelines:

  • The Authority is to be notified of an appointment or change in the appointment of a PRUIC.
  • If a PRUIC is absent for more than 28 days, another pharmacist is to be appointed.
  • The PRUIC may not practice as such in more than one pharmacy or pharmacy department at a time.

Proprietors may use the VP32 Form Notification of Appointment of Pharmacist in Charge available on the VPA website to notify the Authority.

Recent panel hearings

The Authority held five Panel Hearings between July and September 2021 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises. Three hearings resulted in a reprimand and two resulted in the licensee being cautioned.

A summary of a selection of hearings follows:

Case 1

The licensee allowed a dispensary assistant to access the pharmacy when it was not open for business and when a registered pharmacist was not present in breach of section 31(1) of the Act. In doing so, the licensee failed to restrict the control of keys to the pharmacy premises to registered pharmacists in accordance with Clause 3 of the Schedule to the Act. There were additional matters relating to good pharmacy practice such as cold chain management and reference texts.

The licensee was reprimanded.

Learnings

When a pharmacy or pharmacy department is closed for business, the licensee or the registered pharmacist who is regularly and usually in charge must not allow a person to have access to it unless a registered pharmacist is present.

The panel took into account a range of contributing circumstances when making its decision to issue a reprimand. If the Authority had decided to prosecute the licensee, the Act specifies a penalty of up to 60 penalty units (over $10,000) for a breach of this section.

Case 2

A pharmacist failed to lodge an application for a pharmacy business licence and obtain a licence prior to settlement of purchase of the pharmacy business. The Panel found that the pharmacist carried on a pharmacy business in breach of section 21(1)(c) of the Act as the Authority had not granted a licence to carry on a pharmacy business.

The licensee was reprimanded, the panel accepting that the failure to obtain a licence was due to an unintentinal error.

Learnings

Pharmacists must not take ownership of or commence carrying on a pharmacy business until they have been granted a licence by the Authority. To do so is a breach of the Act and significant penalties apply. The onus is on the pharmacist to comply with the Act irrespective of whether an agent was engaged to assist with the application process.

Applications should be lodged in a timely manner to allow sufficient time for a complete assessment by officers of the Authority including requests for further information. Time sensitive applications should be planned ahead of time. Where there are extenuating circumstances, the applicant may wish to contact the VPA so that it is aware of the situation.

Case 3

In this case, S8 poisons were found stored in a large cardboard box and in a garbage bag in the dispensary awaiting destruction with the licensee confirming that they had been trying to find time to work on the S8 destruction. There was a total of 68 S8 poisons identified. The existing S8 safes were occupied by the pharmacy’s current stock of S8 poisons and would not have been able to hold the S8 poisons requiring destruction. Further, the S8 poisons requiring destruction had not been recorded into the S8 register.

There were also numerous other matters identified e.g., regarding S8 management, workload, cold chain management, reference texts, vaccination, opioid replacement therapy, and dose administration aids.

The licensees were cautioned.

Learnings

All S8 poisons in the possession of the pharmacy must be stored in a lockable drug safe constructed in accordance with the Drugs, Poisons and Controlled Substances Regulations 2017. A larger drug safe or an additional drug safe must be obtained if the existing safe does not provide enough storage for all S8 poisons.

Pharmacists should take all reasonable steps to ensure any returned, unwanted or expired S8 poison is recorded in the drug register when received or identified and a subsequent record made when destroyed in accordance with regulations. This ensures that all S8 poisons in the pharmacist’s possession are accounted for and reduces the risk of misappropriation.

self-audit form is available on the Authority’s website to assist licensees and employee pharmacists to audit their compliance with key requirements of the Act, Victorian Pharmacy Authority Guidelines and good pharmacy practice.

From the inspectors

The guidance information contained in the following sections is general in nature and by no means exhaustive. If you are unsure about how particular requirements apply to your pharmacy, contact the Victorian Pharmacy Authority. Pharmacists may wish to refer to the Resources section for information on compounding matters covered in this Circular.

Compounding risk assessment

The Pharmacy Board of Australia’s Guidelines on compounding of medicines require pharmacists who compound medicines to have appropriate risk management processes in place to manage risk associated with the compounded product and the workplace. In the case of complex compounding, pharmacists are advised to document the process.

The current edition of the Australian Pharmaceutical Formulary Handbook (APF25) provides further information on risk assessment in the Compounding section. The APF25 broadly categories risk as being related to the:

  • Premises e.g. there being no powder containment cabinet for the handling of hazardous substances.
  • Product e.g. compounding formulas are not obtained from reputable sources confirming quality, stability, safety, efficacy, and rationality.
  • Personnel e.g. personal protective equipment is inadequate.
  • Patient e.g. allergy to an excipient.

The outcome of the risk assessment may include the pharmacist taking actions to effectively manage the risks or deciding not to compound that product.

The APF25 also states that additional risk assessment is required if the use of a non-pharmacopoeial formula is necessary (e.g. when making changes to an existing APF or pharmacopoeial formula). Further, pharmacists who are requested to compound medicines for which there is no published literature about safety, efficacy, pharmacokinetics, and clinical data should undertake a risk assessment to determine if it is appropriate to compound the medicine.

Pharmacists may wish to refer to the Pharmaceutical Society of Australia’s Professional Practice Standards 2017 for the compounding standard and Appendix 7 Compounding decision support and risk assessment tool.

It is not sufficient to rely on compounding formulas inherited from other pharmacists or to compound based on testimonials and impressions of peers without careful examination.

Am I undertaking complex compounding?

According to the Pharmacy Board of Australia’s Guidelines on compounding of medicines and the APF25, complex compounding requires or involves special competencies, equipment, processes and facilities to manage the higher risk associated with the preparation of these products. Pharmacies should avoid complex compounding if they are not adequately equipped.

The VPA guidelines 4.6 Pharmacies undertaking complex compounding specify requirements for complex compounding in pharmacy premises. VPA inspectors have found pharmacies undertaking complex compounding without a dedicated laboratory.

For pharmacies intending to undertake complex compounding, the addition of a compounding laboratory is considered a significant alteration and a VP21 application form should be submitted for review and approval by the Authority prior to construction.

Can I batch compound?

VPA inspectors have observed pharmacies preparing batches of compounded medicines in anticipation of receiving prescriptions or orders. This is not permitted given that exemptions allowing pharmacists to compound medicines are based on pharmacists compounding for a particular (named) person.

The Therapeutic Goods Regulations 1990 provide exemptions from the requirement to hold a manufacturing licence and to include therapeutic goods in the ARTG in particular circumstances, including:

  • when therapeutic goods (other than biologicals) are (i) produced by the pharmacist in a pharmacy where the pharmacist practices and the pharmacy is open to the public and (ii) the goods are supplied (other than by wholesale) on or from those premises; and
  • where the therapeutic goods are extemporaneously compounded by a pharmacist for a particular person for therapeutic application to that person.

Pharmacists may wish to refer to GMP information for manufacturers of compounded medicines and DAAs on the TGA website for more information regarding the exemptions.

The Pharmacy Board of Australia’s Guidelines on compounding of medicines defines batch preparation as the creation of a batch of multiple units of issue of a product. The guidelines remind pharmacists that they may only engage in batch preparation when they have a prescription or order for individually named patients for an identical compounded medicine.

The Board guidelines require the pharmacist to conduct a risk assessment before compounding a batch to consider the associated risks such as a compounding error or contamination having the potential to affect a larger number of patients and document actions taken to effectively manage the risks. The Board does not encourage batch preparation.

Recent case studies

Case studies recently published by the Pharmacy Board of Australia and the Pharmacy Council of NSW should be essential reading for compounding pharmacists. They further illustrate requirements and risks relating to complex compounding and provide useful information on lessons to be learned.

For information

Mobile or outreach service (off-Site COVID-19 vaccination)

The National COVID Vaccine Taskforce has made changes to the COVID-19 Vaccination in Community Pharmacy (CVCP) Program to enable participating community pharmacies to administer COVID-19 vaccines off-site. A full list of requirements for off-site vaccinations can be found in the revised CVCP Program Rules.

Pharmacists must also adhere to Victorian legislation for remote or outreach vaccination services as outlined in the Secretary Approval: Pharmacist Immuniser – SARS-CoV-2 (COVID-19) VACCINE and the requirements described in the Victorian Department of Health’s Victorian Pharmacist Administered Vaccination Guidelines. VPA inspectors will monitor for written policies and procedures in accordance with the department’s guidelines.

Further, pharmacists are advised to refer to the National Vaccine Storage Guidelines Strive for 5 for guidance on how to appropriately transport and monitor vaccines outside the pharmacy.

Amendment to the APF25 expiry date guidance

The Australian Pharmaceutical Formulary Handbook (APF) Editorial Board has approved an amendment to the APF25 expiry date guidance on non-sterile compounded medicines in the Good Compounding practice chapter to include the following statement:

The expiry date of compounded capsules or powders is 6 months or less from the date the medicine is compounded, provided the ingredients are stable in air and not hygroscopic or deliquescent.

Further information about the amendment can be found on the APF page of the Pharmaceutical Society of Australia website.

Resources

Supporting key learnings from recent inspections and areas of high risk, licensees and pharmacists may wish to refer to the following resources alongside the VPA Guidelines. Resources are not limited to the list below and pharmacists are encouraged to review other relevant references as required.

  • Pharmacy Board of Australia Guideline on compounding medicines here.
  • Pharmacy Board of Australia FAQ for pharmacists on the compounding of medicines here.
  • Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs here.
  • Pharmaceutical Society of Australia’s Professional Practice Standards 2017 here.
  • Current edition of the Australian Pharmaceutical Formulary Handbook.
  • Pharmacy Board of Australia Guidelines for proprietor pharmacists here.
  • Pharmacy Board of Australia Guidelines on practice-specific issues - Guideline 1 (List of reference texts for pharmacists) here.
  • Pharmacy Board of Australia Guidelines on dose administration aids and staged supply of dispensed medicines here.
  • Pharmacy Board of Australia Guidelines for dispensing of medicines with reference to requirements for barcode scanning here.
  • DPCS Regulations 2017 with reference to requirements for recording, storage and reconciliation of Schedule 8 poisons here.
  • Medicines and Poisons Regulation: Managing Schedule 8 poisons here.
  • Medicines and Poisons Regulation: Dispensing medicines here.
  • National Vaccine Storage Guidelines "Strive for 5" here.
  • Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services here.

Members of the Victorian Pharmacy Authority

Mr D McConville, Chair   (Pharmacist member)
Ms E Kennedy   (Lawyer member)
Ms C Fersterer   (Pharmacist member)
Mr B Moar   (Pharmacist member)
Ms M Ritchie   (Community member)
Mr D Sanghvi   (Pharmacist member)

Authority Staff

Registrar: Mr A Bawden
Senior Pharmacist: Mr D Thirlwall
Pharmacist: Mrs C Greco (Program Officer - Licensing and Registration)
Pharmacist: Dr J Snell (Governance and Risk Officer)
Pharmacist: Ms J Webster (Authorised Officer)
Pharmacist: Ms T To (Authorised Officer)
Pharmacist: Ms K La (Authorised Officer)
Chief Finance Officer: Mrs K Nadanakumar
Administration Officer: Mrs H Newett

Address: Level 2, 15-31 Pelham Street, Carlton, Victoria, Australia 3053
Telephone: (03) 9653 1700
Email: enquiries@pharmacy.vic.gov.au
Website: www.pharmacy.vic.gov.au

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Frequently Asked Questions