Wednesday, 31 May 2023

Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023

Statement of compatibility

Mary-Anne THOMAS (Macedon – Leader of the House, Minister for Health, Minister for Health Infrastructure, Minister for Medical Research) (10:11): In accordance with the Charter of Human Rights and Responsibilities Act 2006 I table a statement of compatibility in relation to the Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023.

Opening paragraphs

In accordance with section 28 of the Charter of Human Rights and Responsibilities Act 2006, (the Charter), I make this Statement of Compatibility with respect to the Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023.

In my opinion, the Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023, as introduced to the Legislative Assembly, is compatible with human rights as set out in the Charter. I base my opinion on the reasons outlined in this statement.

Overview

The Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Bill 2023 (the Bill) amends the Drugs, Poisons and Controlled Substances Act (the Act) to enable the Victorian Government to make regulations to authorise pharmacists to initiate the supply of Schedule 4 medicines without a prescription or direction from a prescriber.

Clause 3 of the Bill inserts the new regulation making powers in section 129 of the Act, expressly allowing regulations to be made authorising pharmacists to supply, dispense, administer, use or sell Schedule 4 poisons in specified circumstances and subject to conditions, for specified activities, or in accordance with the approval of the Secretary to the Department of Health – without a prescription or other instruction or authorisation from a prescriber.

These new regulation making powers are needed to deliver a 12-month pilot, trialling an expanded role for pharmacists. The aim of the pilot is to simplify and improve access to high volume/low risk primary care, and to reduce the burden of this work on general practitioners, allowing them to focus on providing more complex care.

The majority of the Charter impacts will be assessed when regulations are made under the new powers.

Human Rights Issues

The Bill itself will not engage the Charter rights of individuals. However, regulations made under the new powers may have an effect on Charter rights. The impact that any regulations made under the new powers might have on the rights of individuals will be considered when a human rights certificate is developed, as required by the Subordinate Legislation Act 1994.

Where the Bill may have the potential to impact on Charter rights through regulations made subsequently, an overview is provided below.

Human rights protected by the Charter that are relevant to the Bill

The amendments in the Bill may, through expanded regulation making powers, engage the right to life. Section 9 of the Charter provides that every person has the right to life and has the right not to be arbitrarily deprived of life.

Schedule 4 poisons are prescription only medicines, such as antibiotics and strong analgesics, and do not include Schedule 8 poisons (which are controlled drugs with strict legislative controls). Except for some limited exceptions, Schedule 4 poisons must be prescribed by an authorised healthcare professional such as a registered medical practitioner, nurse practitioner or dentist, and can then be dispensed by a pharmacist.

The pilot is anticipated to allow supply without a prescription in strictly defined circumstances, for example continued supply of the oral contraception pill, treatments for some mild skin conditions and antibiotics for uncomplicated urinary tract infections, in accordance with established protocols. These protocols will be designed to ensure consumer safety and quality care.

The amendments in the Bill are necessary to support the pilot, which is intended to increase access to safe and timely treatment for common health conditions, supporting community health and wellbeing and easing the burden of disease associated with these conditions.

While the new regulation making powers are not limited to the pilot, Charter impacts would have to be assessed before any regulations authorising pharmacists are made. The Bill allows for regulations to be made that authorise pharmacists to supply, dispense, administer, use or sell Schedule 4 poisons in specified circumstances and subject to conditions, for specified activities, or in accordance with the approval of the Secretary to the Department of Health. This will ensure that any future regulations made will have appropriate safeguards in place to protect consumer health and safety.

Therefore, the amendments in the Bill do not limit the right to life.

The Hon Mary-Anne Thomas MP

Minister for Health

Second reading

Mary-Anne THOMAS (Macedon – Leader of the House, Minister for Health, Minister for Health Infrastructure, Minister for Medical Research) (10:11): I move:

That this bill be now read a second time.

I ask that my second-reading speech be incorporated into Hansard.

Incorporated speech as follows:

The Bill will create a mechanism for pharmacists to be legally authorised to supply certain prescription medicines without a prescription to enable the Community Pharmacist Statewide Pilot.

The 12-month Pilot expands the role of community pharmacists and will make it easier and cheaper for Victorians to get the healthcare they need. It will help improve access to primary healthcare, particularly for women, and help ease pressure on GPs and hospitals, particularly in regional areas.

The Bill will make a minor amendment to the Drugs, Poisons and Controlled Substances Act 1981, creating a power to make regulations that authorise pharmacists to supply specified Schedule 4 medications without a prescription.

This is the first step in creating the legal and regulatory framework for pharmacists to supply medications under the Pilot. Following passage of the Bill, it is intended to make amendments to the Drugs Poisons and Controlled Substances Regulations 2017, which will create a mechanism for the Secretary to the Department of Health to issue an authorisation for pharmacists to supply specified Schedule 4 medications without a prescription, subject to certain conditions outlined in the authorisation.

Under the Pilot, participating community pharmacists will supply relevant specified medicine directly to consumers, without a prescription or direction from another prescribing health practitioner but according to established protocols for the identified health condition groups. This approach – known as structured prescribing under the national Health Professionals Prescribing Pathway framework – is consistent with the New South Wales clinical trial and Queensland urinary tract infection pilot.

The authorisations under the Act and Regulations will aim to reflect and achieve the key objectives of the Pilot – providing Victorians with improved access to timely primary health care and effective treatments for select health conditions, while ensuring that care is provided by an appropriately authorised and trained community pharmacist, following suitable clinical protocols.

The Pilot will provide the community access to treatment for three select health condition groups:

• Continued supply of the oral contraceptive pill for women without a prescription.

• Treatments for some mild skin conditions; and

• Antibiotics for uncomplicated urinary tract infections in women.

Pharmacist immunisers participating in the Pilot will also be authorised to administer select travel vaccines following the completion of additional training.

Implementing this Pilot will make it easier for Victorians to access the primary health care services they need in their communities. This includes easier access to oral contraception and rapid treatment for uncomplicated urinary tract infections – a condition that affects more women than men, with nearly one in three women requiring treatment before the age of 24.

While general practice continues to be the cornerstone of the primary healthcare system, pharmacists are an accessible and trusted health professional in the community. They have a wealth of experience and are highly trained healthcare professionals who already manage a range of health conditions and refer customers to a doctor when required.

The Pilot is consistent with other reforms being considered or progressed nationally across other Australian jurisdictions. Following a successful pilot, pharmacists in Queensland are now permanently able to supply medicines for uncomplicated urinary tract infections through structured prescribing. A statewide clinical trial is also taking place in NSW, for appropriately trained pharmacists to supply certain treatments for uncomplicated urinary tract infections and continue a prescription for the resupply of a low-risk oral contraceptive pill for women under structured prescribing protocols.

To ensure there is no financial barrier for Victorians to access services under the Pilot, consumers receiving an approved service from a pharmacist will pay no more than if they had visited a bulk-billing GP.

Strong clinical governance will be in place to ensure patient safety and quality of care is at the centre of the Pilot. Community pharmacists will be required to complete additional training to participate in the Pilot and will need to follow clear structured protocols and guidelines for prescribing the medicines. This will ensure pharmacists can provide safe clinical care, are familiar with the latest evidence or recommendations and comply with relevant legislation.

The Department of Health will engage with Victoria’s key primary care partners including pharmacy, general practice, clinicians, and consumer groups throughout the Pilot, to inform the Pilot design and implementation, and to ensure patient safety.

By enabling the Bill, the Victorian Government through this Pilot will continue to build on our positive plan to improve access to primary healthcare for all Victorians, closer to home.

Victoria needs to commence the Pilot so that the evaluation findings from this trial can inform the future policy settings on the role of pharmacists and pharmacies that will improve Victorians’ access to safe primary health care, when and where they need it.

I commend the Bill to the house.

James NEWBURY (Brighton) (10:11): I move:

That debate be adjourned.

Motion agreed to and debate adjourned.

Ordered that debate be adjourned for two weeks. Debate adjourned until Wednesday 14 June.