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Circular No. 25 - 30 June 2021

Circular No. 25 - 30 June 2021

In this Circular

  • Chair’s message
  • Licence and registration renewal reminders
  • Special focus: Pharmacy Ownership Audit Program Year 2 Evaluation Report
  • Applications: Updated application forms
  • Quarterly performance report
  • Recent panel hearings
  • For information: How long must prescriptions be kept?
From the inspectors

  • Revised self-audit form
  • Matters relating to dose administration aids
  • Returned or expired medicines
  • Access to current editions of reference texts
  • Drug safe keys

Did you know? Mandatory reporting to the Australian Immunisation Register

Resources

Chair's message

Today (30 June 2021) is the final day for submission of annual licence and registration renewal applications. Licensees are reminded that there is no provision in the Act for late renewals.

This circular sees the introduction of a standing section From the Inspectors highlighting matters observed in recent inspections to support licensees and pharmacists meet their legal and professional obligations. There is also a link to the Authority’s updated self-audit form which all licensees are encouraged to use to audit their compliance with key requirements of the Pharmacy Regulation Act 2010 (Act) and good pharmacy practice.

A report on the second year of the Authority’s Pharmacy Ownership Audit Program is now available on the website. The program has not found any cases of unlawful ownership. The Authority has revised the annual target to 40 ownership audits for 2021, including at least 10 financial audits.

A recent panel hearing highlighted that the onus is on the applicant to apply for the licence which reflects the ownership structure of the pharmacy business and to take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

There is also information on how long to retain prescriptions in the pharmacy which is a query that the Authority often receives.

Please make the circular available to all pharmacy staff.

 

David McConville
Chair

 

Licence and registration renewal reminders

Today (30 June 2021) is the final day for submission of annual licence and registration renewal applications.

Renewal notices were emailed to registered premises and reminders sent in mid-June. There is no provision in the Act for late renewals. If a licence or registration lapses there may be serious professional and/or legal obligations for licensees and pharmacists practising in unregistered premises.

Licence and registration certificates may be downloaded using the Self Service Certificate Download service at www.pharmacy.vic.gov.au after renewal submission and payment.

Please contact finance@pharmacy.vic.gov.au should you have any questions or concerns about renewals.

Special focus

Pharmacy Ownership Audit Program Year 2 Evaluation Report

The Authority is committed to ensuring that all pharmacies in Victoria are owned, operated and controlled only by registered pharmacists in accordance with the Act. To support this goal, the Authority conducts a risk-based pharmacy ownership audit program.

Forty-five ownership audits and one financial audit were completed in 2020. These audits have not detected any unlawful ownership. The Authority received the final reports on a further 6 financial audits in the first quarter of 2021. These have been assessed as compliant.

In total, eighty out of the 101 ownership audits that were selected in 2019 have been completed in the last two calendar years. The remaining audits are planned for completion by 30 June 2021.

A major barrier to progress in 2020 has been delays caused by the coronavirus pandemic. Licensees were given ample time to respond to audits with due consideration for the challenges presented by sustained lockdowns. Delays also occurred as Authority staff adjusted to a different working environment during the pandemic. Further, financial audits can take at least 6 months to complete depending on the volume and complexity of information undergoing assessment and the cooperation of licensees.

The Authority has revised the annual target to 40 ownership audits for 2021, including at least 10 financial audits. The full Year 2 report is available on the Authority’s website.

Applications

Updated application forms

The Authority is committed to identifying improvements to its application processes to improve efficiency and reduce regulatory burden for applicants and other stakeholders. The Authority’s current Statement of Expectations includes a target to transition 50% of licence/registration application forms to electronic formats by 30 June 2021.

The most used application forms have been replaced by updated forms in fillable PDF format in accordance with this target.

The updated forms (marked June 2021) will shortly be available on the Authority’s website. They may be filled electronically or printed and filled manually. Completed forms must still be emailed to the Authority.

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 January 2021 to 31 March 2021 is available on the Authority’s website.

Recent panel hearings

The Authority held three Panel Hearings between April and June 2021 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises. One hearing resulted in a reprimand and two resulted in the licensee being cautioned.

In one case it was found that a company had been carrying on a pharmacy business without a licence in breach of section 21(1)(c) of the Act. The director of the company was granted a licence to carry on the pharmacy business as a natural person but failed to apply for a new licence when they switched to a corporate structure. The licensee was reprimanded.

It appears that some pharmacists still do not fully appreciate the licensing implications of carrying on a pharmacy business as a company versus a natural person. Pharmacists should refer to VPA Communique 4 December 2020 for further guidance on this matter. All applicants and licensees should take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

For information

How long must prescriptions be kept?

Schedule 8 prescriptions
Paper-based S8 poison prescriptions are to be kept for three years and produced on demand to an authorised officer [DPCS Regulations 2017, reg. 66].

For electronic prescriptions, dispensing software must include the functionality to produce required S8 poison prescriptions, on demand, without the pharmacist needing to seek to obtain a copy of a prescription from a third party. [Medicines and Poisons Regulation guidance document Dispensing medicines].

All other S8 transaction records (e.g. Drug of Dependence book, transfer between premises, destruction) must also be kept in a readily retrievable form for 3 years from the date of transaction and produced on demand to an authorised officer [DPCS Regulations 2017, reg 109].

PBS prescriptions
Prescriptions are to be retained for two years [National Health (Pharmaceutical Benefits) Regulations 2017, regs. 59-61].  This includes prescriber bags supplies [www.pbs.gov.au: Supplying Medicines – What Pharmacists Need to Know].

Queries regarding PBS prescriptions can be directed to the Commonwealth Department of Health at pbs@health.gov.au.

All prescription records
Prescription records are to be retained for 3 years. This refers to the usual electronic records, suitably backed up, and applies to all dispensing, irrespective of poisons schedule (if any) [Pharmacy Regulation Act 2010, s. 32 (4)]. The DPCS Regulations 2017, reg 109(4) also impose the same retention time in the case of records for S4, S8 and S9 poisons.

Private (non-PBS/RPBS) prescriptions
Paper-based prescription duplicates which are neither claimable nor S8 do not need to be retained by the pharmacy.

From the inspectors

The guidance information contained in this section 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.

Revised self-audit form

The Authority has revised its Self-audit Form.

The form is designed to assist licensees and employee pharmacists to self-audit compliance with key requirements of the Act, Victorian Pharmacy Authority Guidelines and good pharmacy practice.

The form has been comprehensively updated and reformatted so that it can be filled electronically. The revised Self-audit Form is available on the Authority’s website.

The Authority welcomes any feedback on the revised self-audit form.

Matters relating to dose administration aids

Packing records
VPA inspectors have reported cases where pharmacies had no dose administration aid (DAA) packing records or where the records do not fully comply with the Pharmacy Board of Australia’s Guidelines on dose administration aids and staged supply of dispense medicines. These records help mitigate or detect medication errors and allow for accountability throughout the DAA packing process.

A record of each packing into a DAA should be made under the patient’s name with:

  • each medicine’s name, form, strength and dose
  • the date of packing
  • the initials of the person who packed it and those of the pharmacist who checked it
  • the date of supply of the DAA to the patient or their agent, and
  • the quantity of a patient’s medication that remains after packing.

Pharmacies that engage a third party to pack DAAs should also keep packing records of any changes made to the DAAs at the pharmacy following the supply of the DAAs packed by the third party.

Pharmacists may wish to refer to the Pharmaceutical Society of Australia’s Guidelines for Pharmacists Providing Dose Administration Aid Services for further guidance on best practice.

DAAs and the re-use of medicines
Clause 9(b) of the Schedule to the Act states that adequate arrangements must be in place to ensure that medicines are not re-used after dispensing and after they have left the pharmacy or pharmacy department.

PSA’s Guidelines for Pharmacists Providing Dose Administration Aid Services states that “Any unused medicines in DAA that are returned to the pharmacy or have not been collected from the pharmacy, should be disposed of in accordance with relevant legislation and not be re-used.”  The re-use of medicines in DAAs presents risks of error and drug stability issues.

Returned or expired medicines

Storage
VPA inspectors have observed instances where filled RUM bins were stored in unsecure locations such as storerooms to which all staff members have unrestricted access. Returned or expired medicines should be quarantined in a secure manner and disposed of regularly to prevent build up and misappropriation using Return of Unwanted Medicines (RUM) bins. Returned or expired medicines/filled RUM bins should be stored in the dispensary or in another part of the premises under lock and key to prevent unauthorised access.

Schedule 8 poisons
Returned and expired S8 poisons should be stored in the drug safe until they can be destroyed. Pharmacists should take all reasonable steps to ensure any S8 poison either returned for disposal or past its expiry 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. Using a separate or designated section of the drug register to record “Drugs for Destruction” is a practice that may be helpful in accurately accounting for returned or expired drugs.

Pharmacists may wish to refer to the Authority’s Managing Schedule 8 poisons – a reference guide for pharmacists which has been developed to support pharmacists to understand and comply with their obligations.

Access to current editions of reference texts

Pharmacists must have ready access to the full list of references outlined in the Pharmacy Board of Australia’s Guidelines on practice-specific issues – Guideline 1 (List of reference texts for pharmacists). The Pharmacy Board of Australia’s Guidelines for proprietor pharmacists outline the obligation of proprietors to ensure this occurs.

Having access to contemporary references during the clinical assessment, reviewing, dispensing and counselling processes is essential to the practice of pharmacy and a safeguard to patient safety. Proprietors and pharmacists in charge are strongly encouraged to evaluate whether additional references beyond the mandated list should be available to support the delivery of specialised services such as complex compounding.

It is not acceptable:

  • to hold editions that are out of date without taking steps to acquire current editions.
  • when subscriptions to electronic references have expired.
  • that pharmacists are not provided with the login details to electronic references e.g. locum pharmacists.
  • for references to be unavailable because they have been taken home for study purposes.
  • to select references based on preference rather than the full list.

Proprietors and pharmacists in charge should have a procedure in place to ensure that references are always current, for example:

  • reminders of when subscriptions are due for renewal or when a new edition is due to be released in the case of hard copies.
  • implementing scheduled checks for currency and adequacy of the reference library against the Guideline.

Drug safe keys

VPA inspectors have found instances where the keys to the drug safe are left unsecure on the premises during business hours or overnight e.g. in a drawer, hanging on a hook in the dispensary or in the door of the drug safe. This is not consistent with regulation 74(4) of the Drugs, Poisons and Controlled Substances Regulations 2017 which requires pharmacists to take all reasonable steps to ensure that the drug safe remains locked and secured at all times, except when it is necessary to open it to carry out an essential operation in connection with the poisons stored in it.

Further, VPA Guideline 4.5.1 Storage requires S8 drug safe keys left on the premises overnight to be stored in a safe of similar security to the drug safe to which pharmacists have exclusive access. It would need to be in a discrete location and of substantial construction such that it cannot be easily removed from the premises or broken into.

Did you know?

Mandatory reporting to the Australian Immunisation Register

The Australian Immunisation Register (AIR) is a whole of life, national immunisation register, which records vaccines given to all people in Australia.

Amendments to the Australian Immunisation Register Act 2015 and related instruments have meant any COVID-19 and influenza vaccinations administered by vaccination providers including pharmacist immunisers must be recorded on the AIR from 1 March 2021. This requirement will extend to all vaccinations under the National Immunisation Program (NIP) from 1 July 2021. Vaccination records must be uploaded to AIR as soon as possible after the vaccination event, within 24 hours if it is reasonably practicable to do so but no later than 10 business days after the vaccination event.

In Victoria, the Department of Health’s current Pharmacist Administered Vaccination Guidelines require pharmacist immunisers to report to the AIR any vaccines that have been administered and this includes government or private supplied vaccines. To support patients and their health providers having a more complete history of the administered vaccines, it is expected that pharmacist immunisers record all vaccination encounters to the AIR.

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 Guidelines for proprietor pharmacists here.
  • Pharmacy Board of Australia Guidelines on practice-specific issues - Guideline 1 (List of reference texts for pharmacists) can be viewed here.
  • Pharmacy Board of Australia Guidelines on dose administration aids and staged supply of dispensed medicines can be viewed here.
  • Pharmacy Board of Australia Guidelines for dispensing of medicines with reference to requirements for barcode scanning can be viewed here.
  • Pharmacy Board of Australia Guidelines on compounding of medicines can be viewed here.
  • DPCS Regulations 2017 with reference to requirements for recording, storage and reconciliation of Schedule 8 poisons can be viewed here.
  • Medicines and Poisons Regulation: Managing Schedule 8 poisons can be viewed here.
  • Medicines and Poisons Regulation: Dispensing medicines can be viewed here.
  • National Vaccine Storage Guidelines "Strive for 5" can be viewed here.
  • Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services can be viewed 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
  • Licence and registration renewal reminders
  • Special focus: Pharmacy Ownership Audit Program Year 2 Evaluation Report
  • Applications: Updated application forms
  • Quarterly performance report
  • Recent panel hearings
  • For information: How long must prescriptions be kept?
From the inspectors

  • Revised self-audit form
  • Matters relating to dose administration aids
  • Returned or expired medicines
  • Access to current editions of reference texts
  • Drug safe keys

Did you know? Mandatory reporting to the Australian Immunisation Register

Resources

Chair's message

Today (30 June 2021) is the final day for submission of annual licence and registration renewal applications. Licensees are reminded that there is no provision in the Act for late renewals.

This circular sees the introduction of a standing section From the Inspectors highlighting matters observed in recent inspections to support licensees and pharmacists meet their legal and professional obligations. There is also a link to the Authority’s updated self-audit form which all licensees are encouraged to use to audit their compliance with key requirements of the Pharmacy Regulation Act 2010 (Act) and good pharmacy practice.

A report on the second year of the Authority’s Pharmacy Ownership Audit Program is now available on the website. The program has not found any cases of unlawful ownership. The Authority has revised the annual target to 40 ownership audits for 2021, including at least 10 financial audits.

A recent panel hearing highlighted that the onus is on the applicant to apply for the licence which reflects the ownership structure of the pharmacy business and to take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

There is also information on how long to retain prescriptions in the pharmacy which is a query that the Authority often receives.

Please make the circular available to all pharmacy staff.

 

David McConville
Chair

 

Licence and registration renewal reminders

Today (30 June 2021) is the final day for submission of annual licence and registration renewal applications.

Renewal notices were emailed to registered premises and reminders sent in mid-June. There is no provision in the Act for late renewals. If a licence or registration lapses there may be serious professional and/or legal obligations for licensees and pharmacists practising in unregistered premises.

Licence and registration certificates may be downloaded using the Self Service Certificate Download service at www.pharmacy.vic.gov.au after renewal submission and payment.

Please contact finance@pharmacy.vic.gov.au should you have any questions or concerns about renewals.

Special focus

Pharmacy Ownership Audit Program Year 2 Evaluation Report

The Authority is committed to ensuring that all pharmacies in Victoria are owned, operated and controlled only by registered pharmacists in accordance with the Act. To support this goal, the Authority conducts a risk-based pharmacy ownership audit program.

Forty-five ownership audits and one financial audit were completed in 2020. These audits have not detected any unlawful ownership. The Authority received the final reports on a further 6 financial audits in the first quarter of 2021. These have been assessed as compliant.

In total, eighty out of the 101 ownership audits that were selected in 2019 have been completed in the last two calendar years. The remaining audits are planned for completion by 30 June 2021.

A major barrier to progress in 2020 has been delays caused by the coronavirus pandemic. Licensees were given ample time to respond to audits with due consideration for the challenges presented by sustained lockdowns. Delays also occurred as Authority staff adjusted to a different working environment during the pandemic. Further, financial audits can take at least 6 months to complete depending on the volume and complexity of information undergoing assessment and the cooperation of licensees.

The Authority has revised the annual target to 40 ownership audits for 2021, including at least 10 financial audits. The full Year 2 report is available on the Authority’s website.

Applications

Updated application forms

The Authority is committed to identifying improvements to its application processes to improve efficiency and reduce regulatory burden for applicants and other stakeholders. The Authority’s current Statement of Expectations includes a target to transition 50% of licence/registration application forms to electronic formats by 30 June 2021.

The most used application forms have been replaced by updated forms in fillable PDF format in accordance with this target.

The updated forms (marked June 2021) will shortly be available on the Authority’s website. They may be filled electronically or printed and filled manually. Completed forms must still be emailed to the Authority.

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 January 2021 to 31 March 2021 is available on the Authority’s website.

Recent panel hearings

The Authority held three Panel Hearings between April and June 2021 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises. One hearing resulted in a reprimand and two resulted in the licensee being cautioned.

In one case it was found that a company had been carrying on a pharmacy business without a licence in breach of section 21(1)(c) of the Act. The director of the company was granted a licence to carry on the pharmacy business as a natural person but failed to apply for a new licence when they switched to a corporate structure. The licensee was reprimanded.

It appears that some pharmacists still do not fully appreciate the licensing implications of carrying on a pharmacy business as a company versus a natural person. Pharmacists should refer to VPA Communique 4 December 2020 for further guidance on this matter. All applicants and licensees should take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

For information

How long must prescriptions be kept?

Schedule 8 prescriptions
Paper-based S8 poison prescriptions are to be kept for three years and produced on demand to an authorised officer [DPCS Regulations 2017, reg. 66].

For electronic prescriptions, dispensing software must include the functionality to produce required S8 poison prescriptions, on demand, without the pharmacist needing to seek to obtain a copy of a prescription from a third party. [Medicines and Poisons Regulation guidance document Dispensing medicines].

All other S8 transaction records (e.g. Drug of Dependence book, transfer between premises, destruction) must also be kept in a readily retrievable form for 3 years from the date of transaction and produced on demand to an authorised officer [DPCS Regulations 2017, reg 109].

PBS prescriptions
Prescriptions are to be retained for two years [National Health (Pharmaceutical Benefits) Regulations 2017, regs. 59-61].  This includes prescriber bags supplies [www.pbs.gov.au: Supplying Medicines – What Pharmacists Need to Know].

Queries regarding PBS prescriptions can be directed to the Commonwealth Department of Health at pbs@health.gov.au.

All prescription records
Prescription records are to be retained for 3 years. This refers to the usual electronic records, suitably backed up, and applies to all dispensing, irrespective of poisons schedule (if any) [Pharmacy Regulation Act 2010, s. 32 (4)]. The DPCS Regulations 2017, reg 109(4) also impose the same retention time in the case of records for S4, S8 and S9 poisons.

Private (non-PBS/RPBS) prescriptions
Paper-based prescription duplicates which are neither claimable nor S8 do not need to be retained by the pharmacy.

From the inspectors

The guidance information contained in this section 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.

Revised self-audit form

The Authority has revised its Self-audit Form.

The form is designed to assist licensees and employee pharmacists to self-audit compliance with key requirements of the Act, Victorian Pharmacy Authority Guidelines and good pharmacy practice.

The form has been comprehensively updated and reformatted so that it can be filled electronically. The revised Self-audit Form is available on the Authority’s website.

The Authority welcomes any feedback on the revised self-audit form.

Matters relating to dose administration aids

Packing records
VPA inspectors have reported cases where pharmacies had no dose administration aid (DAA) packing records or where the records do not fully comply with the Pharmacy Board of Australia’s Guidelines on dose administration aids and staged supply of dispense medicines. These records help mitigate or detect medication errors and allow for accountability throughout the DAA packing process.

A record of each packing into a DAA should be made under the patient’s name with:

  • each medicine’s name, form, strength and dose
  • the date of packing
  • the initials of the person who packed it and those of the pharmacist who checked it
  • the date of supply of the DAA to the patient or their agent, and
  • the quantity of a patient’s medication that remains after packing.

Pharmacies that engage a third party to pack DAAs should also keep packing records of any changes made to the DAAs at the pharmacy following the supply of the DAAs packed by the third party.

Pharmacists may wish to refer to the Pharmaceutical Society of Australia’s Guidelines for Pharmacists Providing Dose Administration Aid Services for further guidance on best practice.

DAAs and the re-use of medicines
Clause 9(b) of the Schedule to the Act states that adequate arrangements must be in place to ensure that medicines are not re-used after dispensing and after they have left the pharmacy or pharmacy department.

PSA’s Guidelines for Pharmacists Providing Dose Administration Aid Services states that “Any unused medicines in DAA that are returned to the pharmacy or have not been collected from the pharmacy, should be disposed of in accordance with relevant legislation and not be re-used.”  The re-use of medicines in DAAs presents risks of error and drug stability issues.

Returned or expired medicines

Storage
VPA inspectors have observed instances where filled RUM bins were stored in unsecure locations such as storerooms to which all staff members have unrestricted access. Returned or expired medicines should be quarantined in a secure manner and disposed of regularly to prevent build up and misappropriation using Return of Unwanted Medicines (RUM) bins. Returned or expired medicines/filled RUM bins should be stored in the dispensary or in another part of the premises under lock and key to prevent unauthorised access.

Schedule 8 poisons
Returned and expired S8 poisons should be stored in the drug safe until they can be destroyed. Pharmacists should take all reasonable steps to ensure any S8 poison either returned for disposal or past its expiry 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. Using a separate or designated section of the drug register to record “Drugs for Destruction” is a practice that may be helpful in accurately accounting for returned or expired drugs.

Pharmacists may wish to refer to the Authority’s Managing Schedule 8 poisons – a reference guide for pharmacists which has been developed to support pharmacists to understand and comply with their obligations.

Access to current editions of reference texts

Pharmacists must have ready access to the full list of references outlined in the Pharmacy Board of Australia’s Guidelines on practice-specific issues – Guideline 1 (List of reference texts for pharmacists). The Pharmacy Board of Australia’s Guidelines for proprietor pharmacists outline the obligation of proprietors to ensure this occurs.

Having access to contemporary references during the clinical assessment, reviewing, dispensing and counselling processes is essential to the practice of pharmacy and a safeguard to patient safety. Proprietors and pharmacists in charge are strongly encouraged to evaluate whether additional references beyond the mandated list should be available to support the delivery of specialised services such as complex compounding.

It is not acceptable:

  • to hold editions that are out of date without taking steps to acquire current editions.
  • when subscriptions to electronic references have expired.
  • that pharmacists are not provided with the login details to electronic references e.g. locum pharmacists.
  • for references to be unavailable because they have been taken home for study purposes.
  • to select references based on preference rather than the full list.

Proprietors and pharmacists in charge should have a procedure in place to ensure that references are always current, for example:

  • reminders of when subscriptions are due for renewal or when a new edition is due to be released in the case of hard copies.
  • implementing scheduled checks for currency and adequacy of the reference library against the Guideline.

Drug safe keys

VPA inspectors have found instances where the keys to the drug safe are left unsecure on the premises during business hours or overnight e.g. in a drawer, hanging on a hook in the dispensary or in the door of the drug safe. This is not consistent with regulation 74(4) of the Drugs, Poisons and Controlled Substances Regulations 2017 which requires pharmacists to take all reasonable steps to ensure that the drug safe remains locked and secured at all times, except when it is necessary to open it to carry out an essential operation in connection with the poisons stored in it.

Further, VPA Guideline 4.5.1 Storage requires S8 drug safe keys left on the premises overnight to be stored in a safe of similar security to the drug safe to which pharmacists have exclusive access. It would need to be in a discrete location and of substantial construction such that it cannot be easily removed from the premises or broken into.

Did you know?

Mandatory reporting to the Australian Immunisation Register

The Australian Immunisation Register (AIR) is a whole of life, national immunisation register, which records vaccines given to all people in Australia.

Amendments to the Australian Immunisation Register Act 2015 and related instruments have meant any COVID-19 and influenza vaccinations administered by vaccination providers including pharmacist immunisers must be recorded on the AIR from 1 March 2021. This requirement will extend to all vaccinations under the National Immunisation Program (NIP) from 1 July 2021. Vaccination records must be uploaded to AIR as soon as possible after the vaccination event, within 24 hours if it is reasonably practicable to do so but no later than 10 business days after the vaccination event.

In Victoria, the Department of Health’s current Pharmacist Administered Vaccination Guidelines require pharmacist immunisers to report to the AIR any vaccines that have been administered and this includes government or private supplied vaccines. To support patients and their health providers having a more complete history of the administered vaccines, it is expected that pharmacist immunisers record all vaccination encounters to the AIR.

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 Guidelines for proprietor pharmacists here.
  • Pharmacy Board of Australia Guidelines on practice-specific issues - Guideline 1 (List of reference texts for pharmacists) can be viewed here.
  • Pharmacy Board of Australia Guidelines on dose administration aids and staged supply of dispensed medicines can be viewed here.
  • Pharmacy Board of Australia Guidelines for dispensing of medicines with reference to requirements for barcode scanning can be viewed here.
  • Pharmacy Board of Australia Guidelines on compounding of medicines can be viewed here.
  • DPCS Regulations 2017 with reference to requirements for recording, storage and reconciliation of Schedule 8 poisons can be viewed here.
  • Medicines and Poisons Regulation: Managing Schedule 8 poisons can be viewed here.
  • Medicines and Poisons Regulation: Dispensing medicines can be viewed here.
  • National Vaccine Storage Guidelines "Strive for 5" can be viewed here.
  • Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services can be viewed 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