In this Circular

Chair's message

Welcome to the VPA’s November circular.

A recent highlight was the webinars we held in October on the VPA Standards to support licensees with the introduction of the standards. FAQs on the standards will be available shortly on the VPA website to support licensees that were unable to attend the webinar. We also plan to host forums on other topics in the future.

This circular includes information for flood-affected licensees on providing pharmacy services outside registered premises. Applications for special circumstances approvals will be prioritised by the VPA in the case of natural disasters to facilitate continued provision of pharmacy services.

There is a focus on vaccination services given the recent expansion to the Victorian Pharmacist-Administered Vaccination Program. Based on recent inspections, some key vaccination related areas have been highlighted for licensees to review e.g. vaccination procedures, training and cold chain management.

There is also a reminder about the obligation of licensees to maintain privacy in relation to dispensed medicines as inspectors continue to observe medicines in open baskets being taken to cash registers in pharmacies.

We include a summary of a recent panel hearings with an emphasis on storage requirements for S4 and S8 poisons as well as the management of S8 poisons.

As we near the end of the year, a prudent reminder to applicants to keep in mind that any notifications relating to a change of ownership or commencement of a new pharmacy received after 2pm on 23 December 2022 will not be assessed until the office re-opens in the new year.

David McConville
Chair

Special focus

Floods and Section 29(1)(b)

The VPA will prioritise applications to enable continuity of pharmacy services outside registered premises in special circumstances arising during natural disasters such as the recent flooding in Victoria.

According to section 29(1) of the Pharmacy Regulation Act 2010:

A registered pharmacist must not supply, compound or dispense medicines except—

a) from the premises of a pharmacy business or pharmacy department registered by the Authority; or

b) in any other special circumstances that are approved by the Authority in a particular case.

Licensees can apply for approval to supply, compound or dispense medicines in special circumstances with the VPA by using the VP41 form available on the VPA website.

Fundamental requirements relating to security, hygiene and equipment will need to be met for all special circumstances approvals.

Registered pharmacists are not required to seek VPA approval to undertake activities outside registered premises that do not involve supplying, compounding or dispensing medicines (e.g. medication reviews).

VPA Standards FAQs

The VPA held two webinars about the VPA Standards on 26 & 28 October 2022 to support licensees with the introduction of the standards. Invitations to the webinar were emailed to licensees and registered premises on 6 October 2022. The session was not recorded but FAQs on the standards will be available shortly to support licensees who were not available to attend the webinars.

Applications

When is VPA approval required for a business or activity to be carried on by another person in a pharmacy?

Section 24 of the Pharmacy Regulation Act 2010 provides that:

“a licensee must not authorise, cause or permit any other person to carry on in the registered premises of the licensee any business or activity unless the business or activity is permitted by the licence or approved by the Authority.”

Appendix 7 of the VPA Guidelines provides guidance on when a business or activity carried on at registered premises requires VPA approval.

Each situation will need to be assessed on its own individual facts, and if a licensee has any doubt as to whether any business or activity requires approval, the VPA should be consulted for guidance.

The approval is specific to a licence. If there is a change in ownership but the business or activity continues to operate in the pharmacy, the new licensee will need to apply for a new approval with the VPA.

The VP43 form Application for approval of another business or activity in pharmacy premises is available on the VPA website.

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.

A reminder about privacy

The Pharmacy Regulation Act 2010 (refer Schedule to the Act, clause 9(h)) requires licensees to have adequate arrangements in place to ensure the identity of a medicine being supplied or dispensed cannot be known by another client of the pharmacy or pharmacy department.

When clients carry open baskets of dispensed medicines to cash registers, the nature and identity of the medicines can be known to other clients. Other inadvertent disclosures may occur when prescriptions are sorted at the front counter in clear view of the public or in cases where medications awaiting collection are not stored out of public view.

Refer to VPA guideline 4.3.12 Privacy and confidentiality for further information here.

A focus on vaccination services

Licensees are responsible for ensuring that the delivery of pharmacy services complies with relevant legislation, and follows good pharmacy practice (VPA standard 1.1.2) and this includes the delivery of vaccination services. Given the recent expansion to the Victorian Pharmacist-Administered Vaccination Program, it is timely that licensees review this service.

The following highlights some key areas for consideration:

Governance

• There is a procedure for vaccination services specific to the pharmacy that is clearly documented, regularly reviewed and updated as part of effective governance; and is being followed by staff
• There is an emergency response protocol outlining roles and responsibilities in the event of an emergency. All staff should understand the protocol.

Condition of the vaccine administration area

• The area is private and confidential
• The area is clean, hygienic and uncluttered

Suitably qualified and trained staff

• Pharmacist immunisers must not vaccinate if they do not have a current first aid and cardiopulmonary resuscitation (CPR) certificate. First aid certificates are valid for 3 years. CPR certificates require an annual renewal.
• There must be at least one other staff member on duty in the premises during the vaccination and for 15 minutes afterwards who holds a current first aid and CPR certificate
• VPA inspectors expect to see records of completed training e.g. Immuniser program of study and first aid/CPR certificates and where applicable, mandated COVID-related vaccination training, and completion of the monkeypox and Japanese encephalitis vaccination eLearning modules

Equipment and temperature control

• Schedule regular checks to ensure that the anaphylaxis response kit contains all the items specified in the Victorian Pharmacist-Administered Vaccination Guidelines and is readily accessible by the pharmacist immuniser
• There is a medical bed or suitable reclining chair in the vaccination area for people who prefer to lie down or recline because they may feel faint from the vaccination. This reduces the risk of falls and helps manage the symptom.
• Twice-daily minimum and maximum temperatures should be manually recorded as a timely alert to any breach in the cold chain while data from the drug refrigerator data logger should be downloaded at least weekly (National Vaccine Storage Guidelines ‘Strive for 5’)

Vaccines prepared from multi-dose vials

• The vial is to be labelled and marked with the date and time at which it was first accessed
• Pre-prepared syringes containing vaccine doses are to be clearly and appropriately labelled (vaccine name, vial batch number, date and time of preparation and expiry)

Some useful resources on vaccination are available in the resource section of this circular.

Recent panel hearings

The VPA held five panel hearings between July and October 2022 into allegations that licensees had failed to meet their responsibilities to comply with the Act and the VPA Standards at registered premises.

Summary of a recent panel hearing

The licensee failed to ensure that S4 and S8 poisons were managed in accordance with legislation and good pharmacy practice as required by VPA standard 1.1.3.

• The inspector found 23 returned/unwanted S8 poisons stored in a drawer of the dispensary rather than in a drug safe. The existing drug safes did not have enough room to accommodate all these S8 poisons.
• Medicines held for dose administration aid (DAA) packing were stored in a cupboard with no locks in the storeroom and filled DAAs were stored in the consultation room accessible by non-dispensary staff. Further, a drug refrigerator located in the storeroom used for the storage of vaccines was not locked.
• There was a discrepancy between the S8 register balance and the actual stock on hand for 33 S8 poisons.

There was also non-compliance in other areas such as cold chain management, maintaining current reference texts and DAA records, barcode scanning and vaccination procedures.

The licensee was reprimanded, and the panel imposed a condition requiring the licensee to submit to a further unannounced inspection of the pharmacy at their cost.

Lessons for licensees

• Storage of S4 poisons: S4 poisons must be stored in the dispensary or in a lockable storage facility pursuant to regulation 73 of the Drugs, Poisons and Controlled Substances Regulations 2017. Pharmacists must ensure that the storage facility is locked and secured to prevent unauthorised access. Licensees are also reminded that a functional, 24-hour monitored intrusion detector alarm must cover all areas where medicines and poisons are kept (VPA standard 2.3.3(b)).
• Storage of S8 poisons: The licensee should regularly monitor the pharmacy’s S8 poisons storage capacity and obtain a larger drug safe or an additional drug safe if the existing safe does not provide enough storage. Further, pharmacists should schedule regular destruction sessions to avoid the build-up of unwanted S8 poisons. Non-compliant storage of S8 poisons increases the risk of misappropriation and poses a risk to public safety.
• True and accurate records for S8 poisons: According to the department, delaying the task of making a record in the drug register until it is more convenient is unlikely to satisfy the requirement to record transactions as soon as practicable unless the record is made on the same day as the transaction occurred.
• S8 poisons stock check: The VPA recommends scheduling quarterly S8 poisons stock checks to confirm the balance in the drug register. More frequent checks may be necessary where the pharmacy dispenses a large volume of S8 poisons e.g. nursing homes.
• Current reference texts: VPA standard 1.2.6 requires licensee to ensure that staff have access to current reference texts which includes any essential reference texts specified by the Pharmacy Board of Australia. Licensees who rely on hard copy reference texts are reminded that certain texts have new editions released annually. Setting reminders to renew subscriptions and scheduling regular checks for current references may help with compliance with this standard.

Office closure

The VPA office will close at 3.00pm on Friday 23 December 2022 and re-open at 9:00am on Monday 9 January 2023.

Please note that any notifications (e.g. relating to change of ownership or commencement of a new pharmacy) submitted after 2.00pm on 23 December 2022 will not be processed until 9 January 2023.

For information

Expansion to the Victorian Pharmacist-Administered Vaccination Program

The Secretary Approval for pharmacist immunisers has been amended effective 3 October 2022 to authorise pharmacist immunisers to administer the:

• human papillomavirus (HPV) vaccine to persons aged 12 years and older;
• diphtheria-tetanus-pertussis (DTP) vaccine to persons aged 12 years and older (lowered from 15 years and older);
• pneumococcal vaccine to persons aged 50 years and older; and
• herpes zoster (shingles) vaccine to persons aged 50 years and older.
• monkeypox vaccine to people aged five years and older who are recommended for vaccination as listed on the Victorian Department of Health Monkeypox webpage. Successful completion of a Monkeypox vaccination eLearning module is required prior to administration of the monkeypox vaccine. Additional training requirements apply depending on the administration route of the vaccine.

The amended Secretary Approval: Pharmacist Immuniser, updated Victorian Pharmacist-Administered Vaccination Program Guidelines and communique on the program expansion are available here (under the heading Downloads, towards the bottom of the webpage).

Public health emergency order #22 (PHEO#22)

PHEO#22 was issued on 19 October 2022 authorising a registered pharmacist to supply a Schedule 4 medicine to people affected by floods for continued treatment without a prescription subject to the conditions in the order.

Medicines and Poisons Regulation (MPR) webpage includes advice to pharmacists utilising PHEO#22 as well as alternative options available to pharmacists.

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 Standards and VPA Guidelines. Resources are not limited to the list below and pharmacists are encouraged to review other relevant resources as required.

Vaccination service related resources

• VPA guideline 4.3.13 Facilities for vaccination services here
• Victorian Pharmacist-Administered Vaccination Program Guidelines and Secretary Approval: Pharmacist Immuniser here
• Secretary Approval: Pharmacist Immunisers SARS-CoV-2 (COVID-19) VACCINE here
• Victorian COVID-19 Vaccination Guidelines here
• National Vaccine Storage Guidelines ‘Strive for 5’ here
• ATAGI site requirements for COVID-19 vaccination in community pharmacies here

Other resources

• Drugs, Poisons and Controlled Substances Regulations 2017 here
• Medicines and Poisons Regulation: Managing Schedule 8 poisons here
• VPA’s Managing Schedule 8 poisons – a reference guide for pharmacists here
• Medicines and Poisons Regulation: Dispensing medicines here
• Pharmacy Board of Australia Guidelines on compounding medicines here
• Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs here
• Pharmacy Board of Australia Guidelines for dispensing of medicines here
• 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
• Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services here
• Pharmaceutical Society of Australia’s Professional Practice Standards 2017 here

Members of the Victorian Pharmacy Authority

Mr D McConville, Chair (Pharmacist member)
Ms R Cowie (Pharmacist member)
Ms E Kennedy (Lawyer 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)
Pharmacist: Mr S Savage (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