A matter of life and death


What is Victoria’s controversial Voluntary Assisted Dying legislation, and how will it impact on pharmacists? 

One of the more controversial pieces of legislation in Australian history was passed in Victoria late last year.

In November 2017, the Victorian Parliament passed the Voluntary Assisted Dying Bill 2017. This bill gives, from 19 June 2019, Victorians at the end of life who are suffering and who meet strict eligibility criteria, the ability to request access to voluntary assisted dying.

This new legislation will potentially present that state’s healthcare professionals with situations that will be unlike any they have experienced before, and pharmacists will need to fully understand the rules and regulations included in the voluntary assisted dying process.

How we got here
In 2015, the state parliament’s Standing Committee on Legal and Social Issues was asked to inquire into, consider, and report on the need for laws to allow citizens to make informed decisions regarding their own end-of-life choices.

In June 2016, the Committee tabled its final report and made 49 recommendations, including that Victoria should legalise assisted dying. These were subsequently tabled as the Bill which was passed in November 2017.

In her Second Reading Speech on the Bill, Minister for Health Jill Hennessy said it would provide “a rigorous process with safeguards embedded at every step to ensure that only those who meet the eligibility criteria and who are making an informed, voluntary and enduring decision will be able to access voluntary assisted dying”.

A key component of this was establishing a Voluntary Assisted Dying Review Board, to oversee the process.

The hard work needed to get to the June 2019 kick-off date is being done by an implementation task force which is working on providing a clinical framework for voluntary assisted dying (VAD), creating a model of service delivery, ensuring this is consistent across providers (hospital, community), identifying and implementing training needs, creating the VAD Review Board, identifying a suitable substance(s) to be used and establishing protocols.

The Pharmaceutical Society of Australia is directly involved in the implementation process, and former PSA (Victoria) vice-president Jarrod McMaugh is its representative on the taskforce, which is chaired by Julian Gardner, a lawyer and immediate past Victorian Public Advocate.

So why is PSA involved?
“PSA is involved because this is an important piece of legislation that will impact on the practice of pharmacists, regardless of whether they participate or not,” Jarrod McMaugh told the AJP earlier this year.

“While the PSA neither supports nor contests the availability of a voluntary assisted dying service or the participation of pharmacists in such a service, the PSA represents the interests of pharmacists, and therefore needs to be involved in the implementation taskforce to ensure that pharmacists are not adversely affected by decisions they make about participating or conscientiously objecting to participation,” he said.

“All Victorian pharmacists can be affected by the legislation if they do not understand it, as there are specific sections of the Act that apply to all health professionals.”

Who is eligible?
Clause 9 of the Bill sets out the eligibility criteria for those wishing to access assisted dying. In order to qualify, a person must:

  • be 18 years or older;
  • be an Australian citizen or permanent resident who is ordinarily resident in Victoria;
  • have decision-making capacity in relation to voluntary assisted dying;
  • be diagnosed with a disease, illness or medical condition that is incurable, advanced, progressive and will cause death, and is expected to cause death within less than 6 months or a neurodegenerative condition that is expected to cause death within 12 months; and
    be experiencing suffering that cannot be relived in a manner that the person considers tolerable.

“A person is not eligible for access to voluntary assisted dying if they have a mental illness only, or if they have a disability only,” Mr McMaugh said. “Those with a mental illness and/or a disability, however, are not precluded from taking part if they also fulfil the eligibility criteria.”

He emphasised that the determination of “intolerable suffering” was to be made by the patient, not by a clinician.

One stipulation is that a person seeking to undertake voluntary assisted dying make the request for access to the process themselves. No other party can request voluntary assisted dying on someone else’s behalf. 

“This means that a medical treatment decision maker, such as a power of attorney, cannot make the decision,” the Bill stipulates. “It is not possible for a person to make a statement to request voluntary assisted dying in an advance care directive”.

Who’s not eligible?
A person with dementia is not able to make use of VAD. In its support material, Vic Health says: “When dementia affects a person’s ability to make a decision about voluntary assisted dying, they will not meet the requirements to access voluntary assisted dying.

“To access voluntary assisted dying, a person needs to have the ability to make decisions throughout the process.”

Having a disability or mental illness alone is not sufficient reason for a person to access voluntary assisted dying, Vic Health says.

“Like anyone else, people with a disability or mental illness must also have an advanced disease likely to cause death within 6 months (or 12 months for neurodegenerative diseases) and have the ability to make a decision about voluntary assisted dying throughout the process.”

The process and pharmacists
Jarrod McMaugh spoke at length at the PSA18 conference in Sydney in July this year, explaining the VAD process and how it may/will impact on pharmacy practice.

Doctors who are approached by a patient and who agree to participate need to undergo accredited training before proceeding for the first time.

After accreditation, they must assess the patient and confirm the diagnosis and prognosis.
Referral then must be made to a second doctor (preferably with a specialisation in the area relevant to the request) who must go through the same process. If the second doctor does not agree, the individual can be referred on to any number of doctors.

Once a second doctor has corroborated the prognosis, the individual returns to the coordinating doctor for final discussion and request (in writing) for a prescription. Once the individual has a prescription, they may take it to any pharmacy to be dispensed.

While doctors must undergo accredited training before participating in a VAD case, there is no legislative requirement for pharmacists to do so.

In the first instance, if a pharmacist is approached to dispense the VAD substance, they are not required to participate, nor to refer to a pharmacist who will.

“If you don’t want to participate, you can simply say this, and that you don’t know what to do. I can’t help you. And you don’t have to refer,” Jarrod McMaugh says. “Every pharmacist has the right to object. You don’t have to fill a VAD-related script that is presented to you.”

He does warn, however, that “we don’t really want to see a gravely ill person travelling round the state to try to get a script filled”.

The PSA has a specific position on how this process should be regulated, Mr McMaugh says, “to ensure patients are not unduly distressed or delayed, while maintaining a pharmacist’s right to conscientious objection”.

The other initial factor he highlights is that you can’t raise the topic of voluntary assisted dying with people.

“No health professional may suggest VAD to any person with whom they have a therapeutic relationship—this is considered undue influence,” he says.

Dispensing VAD substances
The legislation does not specify the substance that will be used in the VAD process, but it does specify the dispensing process—much of it is similar to the usual process, Jarrod McMaugh says.

There are specific forms—including to indicate the script has been received, and that it has been filled—that must be submitted to the VAD Review Board at various points after dispensing, adding an extra layer of administrative burden.

One requirement is that the substance must be supplied in a “Locked Box”. If, or when, the substance is used, or indeed, if it will not be used, it must be returned to the dispensing pharmacy for destruction.

Mr McMaugh says participating pharmacists should expect to travel to patient’s homes and discuss the process with them.

“This is really a best practice scenario, not a legislative requirement, but it is certainly what PSA would like to see pharmacists do,” he says.

“It is not part of the legislation that pharmacists would determine intent, but you have to make sure they want to get the script filled, especially if there is a delay between the script provision and presentation.”

The VAD substance
The Victorian legislation specifically does not name a substance. Overseas models (such as exist in The Netherlands or the US state of Oregon) mainly utilise barbiturates, with or without adjuvant medications for side effects, Mr McMaugh says.

Currently most of these agents are listed as Schedule 9 medicines in Australia.

“Specifying the substance in legislation may have provided clarity but could render the legislation inoperable if the substance became unavailable,” he said.

The implementation taskforce will provide several medication options, stratified by preference, based on:

  • ease of use;
  • quality use of medicines; and
  • availability.

There are two specific administration pathways—self-administered and practitioner-administered.
Practitioner administration can only occur if the individual cannot self-administer a VAD substance. No individual may assist in any way. Self-administration will not include parenteral administration.

According to the Department of Health: “In most cases, people will take the medication themselves, by swallowing. If a person cannot swallow or cannot otherwise physically take the medication themselves, they can ask the doctor who first assessed their request to administer medication that will bring about their death. This request must be made in person. The doctor must then apply for a special permit to allow them to administer the medication”.

Any dispensed oral VAD substance must be returned prior to practitioner administration.

Offences
Offences under the Act apply to all health practitioners, even those who oppose the existence of this legislation, Mr McMaugh said.

Notifications covered by the Act are:

  • A registered health professional is obligated to make a notification if they know of another health professional breaching the act.
  • An employer of a health professional must also make a notification in this instance.
  • Any person making a notification in this manner is protected from liability or defamation resulting from this notification.
  • Failure to notify AHPRA in these instances will be considered unprofessional conduct.

Penalties
Infractions incur potentially serious penalties, including life imprisonment for administering a VAD substance without a permit, or assisting another person to consume VAD, even if it was prescribed for them.

Lesser penalties include:

  • Failing to submit VAD forms to the Board—60 penalty units. 
  • Failing to return a VAD substance for destruction—12 months imprisonment. 
  • Influencing a person to access VAD services (even if they do not access VAD)—5 years imprisonment.
  • Influencing a person to consume a VAD substance—5 years imprisonment.
  • Falsifying records required under the Act—5 years imprisonment.
  • Making a false statement in any VAD reports/forms—5 years imprisonment. 

Pharmacist obligations under the legislation

There is no obligation to dispense or refer. Under the legislation, pharmacists must:

  • Ensure the prescription and permit is valid.
  • Label the medication clearly.
  • Provide the dispensed medication in a locked box.
  • Best practice advice is to:
  • Counsel the patient on what to expect.
  • Assess the individual’s enduring intent—is this their choice? (Just having a prescription isn’t an indication of this.)
  • Ensure the contact person understands their obligations.
  • Assess the appropriateness of the medication for its purpose for this individual.

What pharmacists must not do:

  • Assess the validity of the diagnosis.
  • Assess the validity of the prognosis.
  • Assess the validity of the individual’s suffering.

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