EFC

[2020] NSWCATGD 27

NSW Civil and Administrative Tribunal

New South Wales

Medium Neutral Citation:

EFC [2020] NSWCATGD 27

Hearing dates:

17 September 2020

Date of orders:

17 September 2020

Decision date:

17 September 2020

Jurisdiction:

Guardianship Division

Before:

M D Schyvens, Deputy President
Dr G Jamieson, Senior Member (Professional)

Decision:

The Tribunal consents to the following special medical treatment being provided to EFC:

Spectrum Blue Cannabis Oil (THC 10mg/ml, CBD 15mg/ml) up to a maximum dose of 2mls three times per day

This consent is effective for a period of one year from the date of this order.

The Tribunal confers on the Public Guardian, as EFC’s guardian with the authority to give or withhold consent to medical treatment for EFC, the authority to consent to the special treatment proposed in this order, as required, for a period of one year.

Catchwords:

CONSENT TO MEDICAL TREATMENT – application for consent to special medical treatment – “new treatment” – whether proposed treatment is the most appropriate treatment – unregistered cannabis medicine – Therapeutic Goods Administration Special Access Scheme Category B - whether it is manifestly in patient’s best interests that the treatment is carried out – standard treatments not improving patient’s quality of life – patient experiencing agitation, insomnia, and loss of appetite – risk benefit analysis – treatment exhibits very low risk profile and evidence of potential benefit to patient’s quality of life – manifestly in the patient’s best interests to be given opportunity to receive proposed treatment – orders made – Public Guardian given authority to provide ongoing consent to special treatment.

Legislation Cited:

Guardianship Act 1987 (NSW), ss 33(1), 34, 42(2), 44(1)-(2), 45(3)(a), 45(3)(c)-(d), 45A, Pt 5

Guardianship Regulation 2016 (NSW), regs 9, 14,14(a)

Cases Cited:

Nil

Texts Cited:

A I A Ahmed, et al., “Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in patients with dementia” (2015) 232 Psychopharmacology 2587, 2594

G A H van den Elsen, et al. G A H van den Elsen, et al., “Effects of tetrahydrocannabinol on balance and gait in patients with dementia: A randomised controlled crossover trial” (2017) 31(2) Journal of Psychopharmacology 184, 189

Category:

Principal judgment

Parties:

007: Consent to Special Medical Treatment

EFC (the person)
Public Guardian (applicant)
QFC (carer)

Representation:

Nil

File Number(s):

NCAT 2018/00160219

Publication restriction:

Decisions of the Guardianship Division of the Civil and Administrative Tribunal have been anonymised to remove any information that may identify any person involved in the Tribunal’s proceedings: Civil and Administrative Tribunal Act 2013 (NSW), s 65.

REASONS FOR DECISION

Background

1. EFC is a 76-year-old man who, until his recent admission to Public Hospital A, and then subsequently Public Hospital B, lived in a care facility in regional NSW. EFC has Alzheimer’s dementia, and the Public Guardian is currently appointed as EFC’s guardian with functions of health care and medical and dental consent decisions. EFC’s daughter, QFC, is jointly appointed as his guardian with functions of accommodation and services.

2. As a result of his dementia and standard associated treatments, EFC exhibits a number of symptoms, including increased agitation, loss of appetite and insomnia. The application currently before the Tribunal seeks the Tribunal’s consent to the carrying out of special medical treatment, namely the administration of a medicine containing cannabinoids (compounds derived from cannabis).

3. The application to the Tribunal, though formally made by the Public Guardian, was initially triggered by the application of EFC’s treating doctor, Dr Z, to the Public Guardian for its consent to carry out the proposed treatment on EFC. In that application, Dr Z said EFC’s condition requiring treatment is “Severe Alzheimer’s Dementia causing behavioural problems and insomnia not responsive to standard treatment”, and he proposed the use of an oral medicine, “Spectrum Blue”.

4. The relevant ingredients in Spectrum Blue are derived from a hybrid strain of both Cannabidiol (CBD) and Tetrahydrocannabinol (THC). Spectrum Blue contains 10mg/mL of THC and 15mg/mL of CBD. It is an unregistered cannabis medicine, requiring specific Therapeutic Goods Administration (TGA) approval in order to be lawfully supplied in Australia.

5. The Public Guardian, upon receiving Dr Z’s application for consent to carry out the treatment on EFC, made the current application to the Tribunal for its consent to the carrying out of special treatment on EFC.

6. Dr Z told the Tribunal that he has over 15 years’ experience working with medicinal cannabinoid products as a medical practitioner previously in Canada, and now in Australia. At the time of the hearing, Dr Z had sought and received TGA approval by way of an application through the TGA’s Special Access Scheme Category B pathway, and a letter from the TGA stating its approval.

7. QFC, who originally sought Dr Z’s assistance with her father, reported that her father was no longer his usual “upbeat, positive” self, and had “lost his spark”. QFC was present at the hearing via telephone and gave broad support to Dr Z’s submissions.

8. In support of the application, Dr Z lodged a number of documents, including the proposed monitoring plan and titration schedule for administering the treatment to EFC, as well as some peer-reviewed articles in support of his treatment proposal.

9. Also present at the hearing was EFC’s treating doctor at Public Hospital B, Dr Y; the pharmacist overseeing EFC’s medications at Public Hospital B, Mr X; and a discharge nurse, Ms W.

Does Part 5 of the Act apply to EFC?

10. There was no controversy among any of the people in attendance that EFC is a person to whom Pt 5 of the Guardianship Act 1987 (NSW) (“the Act”) applies – that is, he is over the age of 16, and as a result of his dementia, is a person who is incapable of giving consent to the carrying out of medical or dental treatment: s 34 of the Act.

Characterising the proposed treatment

11. Before moving to consider the substantive issue of whether or not the Tribunal should grant consent to the proposed treatment being administered, we must first characterise the treatment in terms of the definitions given under the Act – there are many. The legal characterisation of the proposed treatment determines the relevant considerations to be made in our decision as to whether consent should be given.

12. Section 33(1) of the Act defines medical treatment as, relevantly:

33 Definitions

…

(a)    medical treatment (including any medical or surgical procedure, operation or examination and any prophylactic, palliative or rehabilitative care) normally carried out by or under the supervision of a medical practitioner, or

…

(c)    any other act declared by the regulations to be treatment for the purposes of this Part

13. We note that if the treatment proposed could be characterised as minor or major treatment, there would be no need for the application, because the Public Guardian has authority through the guardianship order to make decisions about consent to those kinds of treatments. As will become apparent, we are able to rule out the characterisation of this treatment as major or minor treatment, because it is more accurately characterised as special treatment, and therefore requires the consent of the Tribunal.

14. The provisions in the Act and Regulations around the various characterisations of special treatment are convoluted. Specific kinds of special treatment are described in three places: s 33(1) of the Act, and regs 9 and 14 of the Guardianship Regulation 2016 (NSW) (“the Regulations”). We set out the relevant provisions below:

1. Section 33(1) of the Act:

33 Definitions

(1)

…

special treatment means:

(a)    any treatment that is intended, or is reasonably likely, to have the effect of rendering permanently infertile the person on whom it is carried out, or

(b)    any new treatment that has not yet gained the support of a substantial number of medical practitioners or dentists specialising in the area of practice concerned, or

(c)    any other kind of treatment declared by the regulations to be special treatment for the purposes of this Part,

but does not include treatment in the course of a clinical trial.

2. Regulations 9 and 14 of the Regulations:

9 Special Medical Treatment

For the purposes of paragraph (c) of the definition of special treatment in section 33 (1) of the Act, the following medical treatment is declared to be special treatment:

(a)    any treatment that is carried out for the purpose of terminating pregnancy,

(b)    any treatment in the nature of a vasectomy or tubal occlusion,

(c)    any treatment that involves the use of an aversive stimulus, whether mechanical, chemical, physical or otherwise.

…

14 Experimental special medical treatment to which Tribunal may consent

For the purposes of section 45 (3) (b) of the Act, the following medical treatment is prescribed special treatment:

(a)    any treatment that involves the administration to a patient of 1 or more restricted substances for the purpose of affecting the central nervous system of the patient, but only if the dosage levels, combinations or numbers of restricted substances used, or the duration of the treatment, are outside the accepted mode of treatment for such a patient,

(b)    any treatment that involves the use of androgen reducing medication for the purpose of behavioural control.

15. As to the question of characterising the special treatment, we were alive to the possibility that the proposed treatment might fall into one of two categories of special treatment described in the legislation, either as:

1. a special treatment of the kind described in paragraph (b) of the meaning of special treatment given in s 33(1) of the Act (“new treatment”); or

2. a kind of “experimental” special treatment of the kind considered in reg 14(a) of the Regulations, and therefore special treatment for the purposes of paragraph (c) of the definition in s 33(1) of the Act (“experimental treatment”).

16. We were able to exclude the possibility of other categories because they were self-evidently irrelevant to the treatment proposed.

Submissions

17. We sought submissions on this point from Dr Z at the hearing. As we noted above, Dr Z’s professional experience includes 15 years working with medical cannabinoids.

18. Dr Z’s submissions were simply, in effect, that the treatment proposed was best defined under the first definition (“new treatment”). He submitted that, in Australia (relative to other jurisdictions), there was only a small number of practitioners prescribing and supporting the prescription of cannabis medicines. He said the second definition (“experimental treatment”) was, on the other hand, not fitting, because the proposed medicine and dosage was not outside the accepted mode of treatment for that medicine in other jurisdictions – in fact, it was, in his opinion, consistent with a standard dose in jurisdictions with more widespread use of the product.

19. Dr Y agreed with that assessment, noting that there was little evidence for its general use, but she was aware of it being prescribed on a case-by-case basis.

20. QFC agreed with and relied upon the submissions of Dr Z.

21. The Public Guardian gave no submission on this point.

Consideration

22. The treatment proposed is the administration of a medicine that is not registered on the TGA Registry and is not otherwise considered a medicine with an established history of use in NSW. It has not yet gained the support of a substantial number of practitioners specialising in the area of practice concerned – namely, treatment of dementia and associated symptoms. We accepted Dr Z’s evidence, which was not contradicted, and found it is more appropriately categorised as “new treatment”, as defined under paragraph (b) of the meaning given to “special treatment” in s 33(1) of the Act.

23. Our use of the term “new treatment” in this context should be read strictly according to the definition of that term in the Act. It should not be misconstrued as a broader suggestion that it is treatment which is, or should be, approved by the TGA as a new or innovative treatment intended for widespread use in the general population, or as a prediction that it will be. It is self-evidently outside our role to comment on those matters.

The substantive issues

24. The Act requires us to be satisfied as to the appropriateness of the treatment in two contexts:

1. A narrower context of the proposed treatment as “new treatment” (see ss 45(3)(a),(c)-(d) of the Act); and

2. A broader context of the proposed treatment in terms of the views of relevant parties, appropriateness of alternative treatments, and the objects of Pt 5 of the Act (see ss 44(1)-(2) of the Act).

25. Pursuant to s 45(3)(c), we must be satisfied that the proposed new treatment is the only or most appropriate way of treating EFC, and is manifestly in his best interests: the Act, s 45(3)(c).

26. Pursuant to s 45(3)(d) of the Act, we must be satisfied that in so far as the National Health and Medical Research Council has prescribed guidelines that are relevant to the carrying out of the treatment – those guidelines have been or will be complied with as regards EFC.

27. We must also be satisfied under s 44(1) of the Act, taking into account all of the considerations in s 44(2) of that Act, that the treatment is appropriate. Those specific considerations include:

1. The subject person’s views;

2. The views of the person proposing the treatment;

3. The guardian’s views (as person responsible);

4. Matters under s 42(2) of the Act (raised in the application for consent to treatment):

1. Grounds on which it is alleged patient is a patient to whom Pt 5 of the Act applies;

2. Particular condition of the patient that requires treatment;

3. Alternative courses of treatment which are available;

4. General nature and effect of each of those courses of treatment;

5. Nature and degree of the significant risks (if any) associated with each of those courses of treatment;

6. Reasons for which it is proposed that any particular course of treatment should be carried out;

5. Objects of Pt 5 of the Act.

28. There is significant overlap in the considerations relevant to the appropriateness of the treatment in both contexts, to the extent that it would be difficult to imagine how the treatment could, for example, be appropriate in the first, narrower context, and not appropriate in the second, broader context.

29. In summary, we understand the fundamental questions for us in the present case are, essentially:

1. Is the treatment for EFC the only or most appropriate treatment, taking into account viable clinical alternatives and risk/benefit considerations, as well as the views of relevant parties; and

2. Is it manifestly in EFC’s best interests that this treatment is carried out?

30. We now move to considering those questions together.

Is Spectrum Blue the only or most appropriate way of treating EFC? Is it manifestly in EFC’s interests that the treatment is carried out?

31. On this point, we sought evidence and submissions from the medical experts, from the Public Guardian representative, and from QFC. We also reviewed the relevant material provided to us, primarily submitted by Dr Z.

32. Dr Y told the Tribunal that there had been deterioration in EFC’s symptoms since being admitted to Public Hospital B, specifically with increased agitation, decreased appetite, and sleeplessness. She said it was not uncommon for EFC to be up for the majority of the night, or to only sleep a few hours. She said the hospital environment, with the coming and going of staff and patients, many of them wearing face masks, was not helpful for EFC’s condition.

33. In relation to the proposed treatment specifically, Dr Y said she believed it would improve his sleep, and “settle” him when he’s awake and decrease his agitation, and she was hoping it could improve his appetite. She said she was hopeful it could also prevent any aggressive behaviour which had previously been exhibited when he was particularly tired and confused. She expressed confidence in Dr Z overseeing the proposed treatment, and his ability to ensure side-effects could be kept to a minimum by slow titration.

34. Dr Z gave his view that, when it came to managing the symptoms which EFC was experiencing, there simply was no “most appropriate” treatment. Having tried anti-psychotics and benzodiazepines previously, and with EFC now being administered risperidone, it was Dr Z’s view that these treatments “slowed [EFC] down”, and “blunted [him] in many ways”.

35. The essence of Dr Z’s submissions was that if the definition of “most appropriate” treatment was framed in terms of improving EFC’s quality of life, whilst minimising risk, then he was confident this could be achieved with Spectrum Blue.

36. Low-dose THC, titrated gradually, had “extremely” well-established evidence of safety in elderly people, Dr Z said, referring to articles submitted with the application, both of which upon our own review, supported that conclusion: (A I A Ahmed, et al., “Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in patients with dementia” (2015) 232 Psychopharmacology 2587, 2594; G A H van den Elsen, et al. G A H van den Elsen, et al., “Effects of tetrahydrocannabinol on balance and gait in patients with dementia: A randomised controlled crossover trial” (2017) 31(2) Journal of Psychopharmacology 184, 189).

37. Dr Z conceded that evidence of the treatment’s efficacy is minimal and low-level, however, he believed the anecdotal evidence was strong, and was consistent with his clinical experience working with cannabinoids. Specifically, he said it was in his view likely it could reduce EFC’s agitation, increase his appetite, and mitigate insomnia.

38. We sought Mr X’s view, as a pharmacist overseeing EFC’s medications, in relation to the use of the proposed treatment in EFC’s case. Mr X said he had no clinical practice evidence around the use of CBD or THC in Alzheimer’s patients, and acknowledged that risperidone “hadn’t had the best outcome” for EFC. He nevertheless disagreed with the notion that Spectrum Blue was the only or most appropriate treatment for EFC at this time. He said admission to a dementia-specific ward, with input from allied health and a medical team with expertise in dementia and Alzheimer’s, would be a superior treatment option. He said that “to pin the outcomes on CBD and THC is misguided”, and might not be the “panacea” hoped for. The proposed treatment, in his view, could increase EFC’s risk of falls and interact negatively with existing medications.

39. In response to Mr X’s evidence, Dr Z essentially agreed that the proposed treatment was not a “panacea”. Dr Z noted that “non-pharmacological management of dementia should be the basis for management of every dementia patient,” that pharmaceuticals have only a small role to play, and that whilst not all other pharmaceutical treatments had been exhausted, there were “no absolutes” when it came to management of symptoms of the kind EFC was exhibiting. In these cases, he said, trying more standard pharmaceuticals was also not guaranteed to be effective, but that treatment should always be individualised to the patient. Dr Z’s overriding perspective, he said, was “do no harm” and “harm reduction”, including with the use of the proposed treatment where standard management has failed. He reiterated his plan to closely monitor EFC’s treatment regimen, and administer the treatment slowly, adjusting the dosage of THC a milligram at a time. With this approach, Dr Z said, EFC’s quality of life could be improved, in a safe manner.

40. The representative for the Public Guardian expressed support for a “trial” of the treatment for EFC, and said the medical evidence provided in the course of proceedings indicated the potential for a positive impact for EFC without undue harm.

31. QFC said she supported the treatment, because it would potentially have fewer side effects than current treatments, and she wanted to see an improvement in her father’s quality of life which, in her view, had declined since being administered previous medications. She said she trusted Dr Z’s expertise, and would support anything that could help her father where previous treatments have failed.

Consideration

42. Dementia is an incurable disease. It follows that we accept Mr X’s evidence that allied health and dementia-specific round-the-clock medical care play a vital role in improving the quality of life of dementia patients. Likewise, we accept the evidence given by Dr Z that pharmaceuticals, in the context of care and management of dementia patients, play a small role. To the extent that EFC’s current standard pharmaceutical treatments, and previous standard treatments, have failed or perhaps exacerbated some of EFC’s symptoms, it is appropriate that alternatives be considered. We accept and agree with Dr Z’s characterisation that, in these circumstances, standard treatments are not absolute.

43. We are not of the view that Spectrum Blue is the “only” appropriate treatment in EFC’s case. However on the evidence before us, we are of the view that having attempted other standard treatments, including benzodiazepines and anti-psychotics, to no avail, it is not necessarily more appropriate in EFC’s case to continue down that path, simply because those medications are most commonly used as standard treatment.

44. We gave considerable weight to Dr Z’s evidence, and in doing so, acknowledge his expertise in the area, specifically that in his view, there was ample evidence on the safety of Spectrum Blue in elderly patients – a view which was supported by the literature before us. We also accept his account that, whilst there is only low or no evidence of efficacy, his confidence in the treatment was based on substantial anecdotal evidence. We note too, that Dr Y expressed support on that point.

45. On the other hand, Mr X, who did not have any clinical experience or expertise in the use of cannabinoids, and who was in disagreement about the treatment being “the most appropriate”, did not offer a specific clinical reason against the use of the treatment, other than to say other standard treatments were available, that Spectrum Blue was likely not a “panacea”, and express concerns about safety.

46. For the reasons previously canvassed (at [42]-[43]), we accept that the treatment proposed is neither the only nor the absolute solution to EFC’s condition, however we are confident that with the oversight and approach proposed, EFC could be given a chance at an improved quality of life, without exposing him to undue risk.

47. In those circumstances, we are of the view that, on balance, Spectrum Blue, in the manner proposed by Dr Z, is the most appropriate treatment for EFC.

48. At this stage of his life, any improvement to EFC’s level of agitation, his appetite, and sleep, so long as that improvement is balanced against any risks associated with the method by which it is achieved, is manifestly in his best interests. We are satisfied that Spectrum Blue, in the manner proposed, meets this criterion.

49. It is manifestly in EFC’s interests that he be given an opportunity to receive treatment which, on the evidence before us, has a very low risk profile, and exhibits a potential benefit to his quality of life which has been pursued, by way of other medications, with very little or no success to date.

National Health and Medical Research Council guidelines

50. Section 45(3)(d) of the Act requires the Tribunal to be satisfied that, insofar as the National Health and Medical Research Council had issued guidelines on the proposed treatment, that those guidelines would be followed. The Tribunal was unable to identify any relevant guidelines published by the National Health and Medical Research Council; Dr Z and Mr X agreed they were unaware of any such guidelines. The Tribunal could therefore not consider whether any such guidelines would be followed.

Ongoing consent by the Public Guardian

51. As the proposed treatment was intended to continue for some months, the Public Guardian was given authorisation to consent to the treatment on a continued basis: s 45A of the Act.

Conclusion

52. The Tribunal consented to the treatment proposed, and gave the Public Guardian authority to consent on a continued basis, for a period of one year.

**********

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales.

Registrar

Decision last updated: 30 October 2020