The Applicant (HCCC) by Application for Disciplinary Findings and Orders filed on 9 June 2017 seeks an order pursuant to s 149A of the Health Practitioner Regulation National Law (NSW) ("National Law") to caution, reprimand, impose conditions on registration and/or, pursuant to s 149B, to impose a fine and/or, pursuant to s 149C, to suspend or cancel a registration or make a prohibition order against the Respondent.
The Applicant also seeks an order pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 (NSW) prohibiting the disclosure of the name of Patients A-U, referred to in the proceedings.
The Complaint filed by the Applicant alleges three complaints against the Respondent.
The Respondent admits that he is guilty of unsatisfactory professional conduct pursuant to ss 139B(1)(a) and (l) of the National Law in respect of Complaint One, and admits the background to Complaint One. Further, the Respondent admits that he is guilty of unsatisfactory professional conduct pursuant to s 139B(1)(b) of the National Law in respect of Complaint Two. The Respondent does not admit that he is guilty of professional misconduct as provided by s 193E.
The background to the complaint is stated as follows.
[2]
Background
The Aura Medical Corporation ("AMC") commenced ketamine treatments in Sydney in November 2014. AMC promoted ketamine to treat major depressive illnesses unresponsive to conventional treatments. Ketamine is a Schedule 8 medication and is not currently approved by the Therapeutic Goods Administration ("TGA") in Australia or indicated in the product information for depressive illnesses.
Between November 2014 and May 2015 the Practitioner was engaged by AMC to assess and treat patients for depression (including severe or major depression). The Practitioner issued a prescription of ketamine and participated in the patients' ongoing treatment.
Prescriptions for ketamine issued by the Practitioner were forwarded to Australian Custom Pharmaceuticals ("ACP"), a Sydney-based compounding pharmacy. Ketamine was then supplied to AMC for subcutaneous administration to patients by the Practitioner and nursing staff. Doses of ketamine were also provided to some patients for self-administration outside of the clinic. The particulars relied upon in support of Complaint One are as follows.
[3]
Complaint One [UPC Admitted]
The Applicant claims that the Respondent is guilty of unsatisfactory professional conduct under s139B(a) and (l) of the National Law, in that the Practitioner has engaged in conduct that demonstrates the knowledge or judgment possessed, or care exercised by the Practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience and/or engaged in improper or unethical conduct relating to the practice or purported practice of medicine.
The particulars relied upon in support of Complaint One are as follows:
1. The Practitioner prescribed ketamine, a type B drug of addiction within the meaning of the Poisons and Therapeutic Goods Regulation 2008 ("PTGR") , to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T and U as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint, for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, contrary to cl 79 of the PTGR.
2. The Practitioner failed to conduct an appropriate assessment when he prescribed ketamine as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
3. The Practitioner failed to exercise responsible medical judgment when he prescribed ketamine to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
4. The Practitioner failed to:
1. communicate;
2. advise; and
3. liaise
with treating practitioners of Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U when he prescribed ketamine as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
1. The Practitioner failed to provide a treatment summary for the benefit of any subsequent health provider to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U when he prescribed ketamine as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
2. The Practitioner failed to provide supervision and ongoing assessment during the course of the ketamine treatment to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U when he prescribed ketamine as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
3. The Practitioner acted without proper authority pursuant to s 28(2)(a) of the Poisons and Therapeutic Goods Act 1966 (NSW) ("PTGA") when he prescribed ketamine a type B drug of addiction within the meaning of the PTGR, for a period exceeding two months to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
4. The Practitioner utilised a consent form when he prescribed ketamine to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint which, when completed by the Practitioner, lacked information about the material risks of the use of ketamine in circumstances where:
1. The nature of prescribing ketamine for depression is experimental; and
2. There is a lack of evidence-based treatment protocol.
1. Having regard to particular 8 above, the Practitioner failed to obtain proper informed consent from Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U.
2. The Practitioner inappropriately prescribed ketamine, a drug of addiction within the meaning of the PTGR, for home administration or as a 'takeaway' dose to Patient H, as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint in circumstances where:
1. Patient H was a minor and lived in Canberra;
2. ketamine injections were often given to Patient H's mother to give to Patient H; and
3. The administration of ketamine to Patient H should have been supervised or alternatively administered by a general practitioner.
1. The Practitioner failed to provide appropriate follow up and support to Patients K, N, Q and R when he prescribed ketamine for home administration or as a 'takeaway' dose as treatment for depression on the dates and in the manner detailed in the Schedule to this Complaint.
2. The Practitioner failed to have proper regard to a history of methamphetamine use when he prescribed ketamine to Patient S on the dates and in the manner detailed in the Schedule to this Complaint.
3. The Practitioner inappropriately prescribed ketamine to Patient N on the dates and in the manner detailed in the Schedule to this Complaint, in circumstances where there is no evidence that an Anxiety and Depression Checklist ("K10 test") and the Montgomery-Asberg Depression Rating Scale ("MADRS") were being used to inform the treatment."
[4]
Complaint Two [UPC Admitted]
The Applicant claims that the Practitioner is guilty of unsatisfactory professional conduct pursuant to s 139B(1)(b) of the National Law in that the Practitioner has contravened the Health Practitioner Regulation (NSW) Regulation 2010, Pt 4, cl 7 and Sch 2.
The particulars to such complaint relied upon by the Applicant are as follows:
1. The Practitioner's medical records with respect to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T and U were inadequate in that he failed to adequately record:
1. Information relevant to his assessment, diagnosis and treatment progress of the patient at each visit;
2. Particulars of any clinical opinion reached by the Practitioner;
3. Particulars of advice and/or information given to the patient; and
4. Plans of treatment and/or discharge plan for the patient.
1. The Practitioner failed to keep adequate medical records with respect to Patients A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, and U in that the records did not contain sufficient information that would enable another medical practitioner to carry on the management of those patients."
[5]
Complaint Three [Professional Misconduct Not Admitted]
The Applicant claims the Respondent is guilty of professional misconduct under s 139E of the National Law. The Applicant asserts that the Practitioner has engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of his registration; engaged in more than one instance of unsatisfactory professional conduct such that when the instances are considered together, they amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the Practitioner's registration. The particulars of Complaint Three are those contained in the particulars to Complaints One and Two.
[6]
Complaint One
The Respondent admits that he is guilty of unsatisfactory professional conduct pursuant to ss 139B(1)(a) and (l) of the National Law, and admits the background to Complaint One.
1. The Respondent admits Particular 1.
2. The Respondent denies Particular 2.
3. The Respondent denies Particular 3.
4. The Respondent admits Particular 4.
5. The Respondent admits Particular 5.
6. The Respondent denies Particular 6.
7. The Respondent admits Particular 7.
8. The Respondent admits Particular 8.
9. The Respondent admits Particular 9.
10. In relation to Particular 10, the Respondent does not admit that the prescribing of ketamine in the circumstances outlined was inappropriate. The Respondent admits subparagraphs (a) and (b) but denies subparagraph (c).
11. The Respondent denies Particular 11.
12. The Respondent denies Particular 12.
13. The Respondent denies Particular 13.
[7]
Complaint Two
The Respondent admits that he is guilty of unsatisfactory professional conduct under s 139B(1)(b) of the National Law, as referred to in Complaint Two.
1. In relation to Particular 1, the Respondent admits subparagraph (d) but denies subparagraph (a), (b) and (c).
2. The Respondent admits Particular 2.
[8]
Complaint Three
The Respondent does not admit that he is guilty of professional misconduct pursuant to s 193E of the National Law.
1. In relation to the Particulars, the Respondent repeats and relies on the replies provided in relation to Complaints One and Two.
Certain of the particulars relied upon by the Applicant are admitted but others are disputed, as is set out hereunder.
[9]
Medical Council of New South Wales
On 19 November 2015, proceedings were convened pursuant to s 150 of the National Law. During the hearing of those proceedings, the following issues were identified for consideration:
1. Dr Chen prescribed ketamine injections "off label" to treat depression for at least 150 patients despite holding no specialist qualification in Australia. Most of Dr Chen's practice in Australia since 1992 has been as an orthopaedic Career Medical Officer ("CMO").
2. Ketamine, a rapidly acting general anaesthetic agent, is not approved in Australia for the treatment of depression. Dr Chen's prescribing is contrary to cl 79 of the PTGR, as he issued prescriptions for a drug of addiction in a quantity or for a purpose that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
3. Dr Chen had "two to three days training" from Associate Professor Graham Leslie Barrett in Melbourne, who is not a specialist prescriber. Dr Barrett appears to have been involved in the conduct of a company known as AMC and in the operation of the clinic referred to hereunder.
4. Dr Chen's responses to the above and other issues raised grave concern for both the Council's delegates and the Pharmaceutical Services Unit investigator who gave evidence at the proceedings.
5. The delegates seriously considered suspension but decided to impose practice conditions.
6. Dr Chen was unable to provide the Council with details of insurance with an approved professional indemnity insurer for his practice outside his position as a CMO.
As a consequence, from 5.00pm on Thursday 19 November 2015, the following conditions were imposed upon the registration of the Practitioner:
[10]
Practice Conditions
1. To obtain Medical Council of NSW approval prior to changing the nature or place of his practice.
2. To practice only in a Medical Council of NSW approved public hospital position as a junior resident medical officer.
3. Not to undertake locum positions.
4. To practice under Category B supervision in accordance with the Medical Council of NSW's Compliance Policy - Supervision (as varied from time to time) and as subsequently determined by the appropriate review body.
5. At each meeting the Practitioner is to review and discuss his practice with his approved supervisor with particular focus on:
1. Medical record keeping including medical record reviews;
2. Appropriate prescribing practices; and
3. Knowledge of ethical and professional conduct.
The Respondent sought a review of such conditions and proceedings were convened under s 150A of the National Law. Effective 17 January 2016, the following amendment was made to Practice Condition 2: "To practice only in a Medical Council of NSW approved public hospital position as a junior resident medical officer or as a career medical officer."
The Respondent sought a further review of such conditions and the condition above was further amended as follows, effective 21 December 2016: "To practice only in a Medical Council of NSW approved public hospital position as a junior resident medical officer, a career medical officer or in a Council-approved GP Training Program."
[11]
The Practitioner's Qualifications
The Practitioner completed a MBBS in 1984 at Wannan Medical College in China and an MD in 1990 at Beijing Medical University in China. He worked as a doctor in China from 1983 to 1992. He completed a MBBS from the University of Queensland in 2001.
The Practitioner came to Australia in 1992. Since that time he has mostly practised as a CMO or unaccredited registrar, having not qualified as a GP, psychiatrist or other specialist. He has worked in almost 30 positions since 1992, in South Australia, New South Wales, Queensland and, currently, the Northern Territory.
Of note, the Practitioner had no experience outside hospital employment prior to 2014-2015, except working from January 2006 to June 2006 as an After-Hour General Practitioner in Brisbane. Of note he worked as a part-time CMO in the Emergency Department at Auburn Hospital (February 2011 to February 2014) and as a part-time CMO at North Shore Private Hospital (February 2011 to November 2015).
The Practitioner worked for the Advanced Medical Institute ("AMI"), owned by AMC, as a "locum" on a part-time basis, one to two days per week, arranged by a locum agency, from June 2014 to November 2014. This clinic treated male sexual dysfunction.
The Practitioner moved within the same company to work for AMC from November 2014 prescribing ketamine until it closed in May 2015. After this he continued to prescribe ketamine for a small number of the Clinic's patients until August 2015. The Clinic ("the Clinic") was located at 80 William Street, Sydney and he also attended clinics owned by AMC in Parramatta, Melbourne and Brisbane.
The Practitioner joined the GP Training Program in 2016. He worked in the Emergency Department at Orange Hospital from April 2016 to November 2016; as an unaccredited registrar in Dermatology in Darwin from February 2017 to July 2017; as a GP registrar in a general practice at Central Australia Aboriginal Congress in Alice Springs from July 2017 to February 2018. He commenced in his current employment as a GP registrar in a general practice at Bath Street General Practice in Alice Springs in February 2018.
[12]
Ketamine
Ketamine is currently approved as an anaesthetic drug by the TGA in Australia and by Medsafe in New Zealand. It is well known as a general anaesthetic and a short acting analgesic. It is not currently approved for use in treating depression and research continues into the possible risks and benefits of its use as an antidepressant.
There are no established evidence-based treatment guidelines for ketamine in the treatment of depression as it is a novel, experimental treatment in that context. Ketamine has hallucinogenic effects and can be a drug of abuse. There are recognised risks associated with the use, abuse and overdose of ketamine.
The Tribunal heard evidence that the Practitioner was under commercial pressure to prescribe ketamine. The clinic where he was engaged only prescribed the one drug. The patient did not see the prescription: rather it was sent directly for compounding by an organisation associated with the clinic. The cost to the patient per injection was $150.
The Tribunal was told by the Practitioner that he was instructed by Dr Barrett, the Director of Aura Medical, to prescribe ketamine in batches of 24 doses. Initially these doses were in vials which were drawn up for injection; later the doses came in pre-prepared syringes. Since June 2015 Dr Barrett has had an undertaking on his registration not to possess, prescribe, dispense, or administer ketamine until approved to do so by the Medical Board of Australia.
The Tribunal heard evidence that apart from having spent two mornings with Dr Barrett in Melbourne, the Practitioner had no experience with the assessment of depressed patients since graduating from university in 2001. He asserted that he had past experience with the use of ketamine in sedation and anaesthesia for children and in analgesia in adults. He had no prior experience using it for depression.
[13]
Expert Evidence - Dr Harry Nespolon
The Applicant has provided the Tribunal with reports of Dr Harry Nespolon dated 3 May 2016 and 3 August 2016. A supplementary report is dated 12 December 2016.
Dr Nespolon provided oral evidence during which he expanded upon his written reports, which concentrated upon instances involving 21 patients. Such patients had been seen at the clinic in William Street Sydney in the period from late November 2014 to May 2015. Dr Chen stated that from early 2015, two registered nurses were also employed at the Clinic.
Dr Nespolon was asked, in respect of each of the patients who received ketamine prescribed by the Practitioner, whether the treatment fell significantly below the standard expected of a practitioner of the Practitioner's training and experience and, if so, whether the departure from the standard invited strong criticism. In each case, Dr Nespolon found that the standard both fell significantly below the expected standard and invited strong criticism. Dr Nespolon concluded the same in regard to the Practitioner's treatment of each patient.
Dr Nespolon observed that the Practitioner did not have any post-graduate training in the diagnosis or the treatment of treatment-resistant depression. There was no evidence that the Practitioner took any steps to improve his psychiatric knowledge or skills required to make an accurate diagnosis. He observed that the Practitioner issued 220 prescriptions for a total of 3,670 individual doses of injectable ketamine, which amounted to an average of 16 doses per patient, to 171 patients during the period 21 November 2014 to early June 2015, for depression. Dr Nespolon noted that the use of ketamine for depression has been for severe and resistant depression; it is an area of research only, and a protocol has not been established regarding the dose, the length of treatment, nor an appropriate maintenance therapy.
Dr Nespolon noted that there should have been a history recorded and also a record of the physical and mental state examination conducted of each patient.
In respect of certain patients, Dr Nespolon noted that patients with treatment-resistant depression may not have required treatment on presentation: that those patients could have been asked to obtain a referral from their treating psychiatrist and/or GP that contained their medical and psychiatric history.
In respect of some of the sample patients, Dr Nespolon considered that the records maintained by the Respondent were, as far as they were legible, inadequate. They contained limited detail that would enable any third party to have an insight into the medical history of the patient and were very brief. There is no detailed report, and no evidence of any supervision during the treatment regime, nor of follow-up treatment proposed. He considered that good practice required a clinical history and details of functional impairment. These details were absent.
In addition, Dr Nespolon considered that enquiries should have been recorded concerning any treatment that the patient was already undergoing, and the names of treating professionals.
Further, Dr Nespolon observed that there should have been provision for careful monitoring of the patients to determine whether the treatment being administered by the Respondent, namely ketamine, was the appropriate treatment for such patient, and whether following its administration there was any deterioration.
Dr Nespolan observed that there is no evidence in the medical records of any follow-up support following the administration of ketamine. Dr Nespolon considered that responsible medical practice would have provided details of the initial assessment including a judgement related to functional factors and ongoing treatment together with some provision whereby the patient might contact, after hours, the clinic or nursing staff should difficulties arise with the treatment, and that these precautions should have been in place every time a patient received an injection.
The evidence suggested that two psychological evaluations had been provided to patients, namely a Kessler Psychological Distress Scale (K10) and a Montgomery-Åsberg Depression Rating Scale (MADRS). Dr Nespolon did not regard such tests as adequate. There was little reference made to what use the Practitioner made of the scores.
[14]
Sample Assessment of patients
In respect of Patient H, it was noted that she was aged 16 years and attended with her mother for ketamine. The Practitioner prescribed her 24x1mL syringes of ketamine on 30 January 2015, and 15x1mL syringes on 1 May 2015. The Respondent initially administered or authorised the administration of 24 injections. The records show that the Respondent prescribed ketamine continuously for this patient from 30 January 2015 to 1 May 2015.
The patient's mother was a registered nurse. Nevertheless, Dr Nespolon considered that there should have been a consultation with a psychiatrist or a child psychiatrist. The records showed no such history.
The records reveal that Patient H was provided with further dosages to administer at home interstate. Dr Nespolon did not consider it appropriate that takeaway doses should have been provided without enquiry about the qualifications of the patient's mother. He referred to the Medical Codes that prohibit relatives providing treatment to members of the family and stated that good medical practice does not permit it, even though it is not illegal.
Within this family, there was a strong history of suicide, yet the medical records of the Respondent do not contain any reference to whether the patient had medical or mental problems; there is no information about her current GP or whether she was then seeing a psychiatrist. Patient H was seen on three occasions by the Practitioner and on 23 March 2015 the Patient's records record that she was "regressing". Nevertheless, the Respondent authorised more ketamine injections without assessing her.
Another patient, a man aged approximately 37 years, received treatment from 20 January 2015 to 19 May 2015. In this period the Respondent administered or authorised the administration of 17 injections together with the supply of six syringes on 24 February 2015, and eight syringes on 19 May 2015 for use by the patient at his home.
The Respondent's medical records did not make an assessment of the patient's depressive symptoms but recorded that the patient had ADHD, but no assessment of its effect. There is no record as to whether the patient had any suicidal ideation; there is no record of any physical examination. There is a record that the patient stopped lithium, but no explanation for the change. There was a note that the patient remained on Endep 50 mg, but it is not recorded when he presented whether he was taking that dose. On 19 May 2015 the notes record that the patient had returned to 25mg of Endep. The notes record that the patient was "busy at work" and "tired" suggesting only mild depression, but there is no assessment contained in the notes.
Patient N, a female age 42 years, was provided with 24x1mL syringes on 21 November 2014 and 15x1 mL syringes on third of June 2015. Included in the 13 injections were four syringes on 24 February 2015 and five syringes on 14 March 2015 for self-administration. The medical records do not contain an assessment of the state of the patient's current depressive symptoms; no record of antidepressant medication being taken; but there is a record that the patient was seeing a psychiatrist. There is no record that the psychiatrist was consulted. Dr Nespolon considered that the records demonstrated a significant failure by the Practitioner.
Patient Q, born in 1948, was prescribed 24x1mL syringes of ketamine on 27 January 2015 and 15x1mL syringes on 26 May 2015. The brief history referred to the patient's depression and current medication. However, it did not describe the extent of the depression. The patient's blood pressure ("BP") is recorded but no dose is recorded for the first administration of ketamine. There is no evidence that the patient's treating team was identified or contacted, yet it is apparent that this patient had a prior history of ECT. Such conduct by the Practitioner invited strong criticism.
Patient R, a female born in 1971 was prescribed 24x1mL syringes of ketamine on 20 February 2015. The Practitioner administered or authorised administration of 17 injections including four syringes on 6 March 2015, three syringes on 27th of March 2015 and four syringes on 24 April 2015 for use at home. There is no assessment of suicidal ideation despite her having been twice admitted to hospital. There is no record of any treatment provided at hospital, nor the condition for which the treatment was given. The patient's psychiatric history consists of a very brief review of the history. The patient had been on another medication for 12 years which had not controlled her depression. The patient had had ECT in the past. There is no evidence of any treating psychiatrist, nor physical examination being conducted by the Practitioner; nor is it documented who prescribed the other medication.
Patient S, a male patient born in May 1966 was prescribed 24x1mL syringes of ketamine on 16 January 2015. Thereafter 21 injections followed. The history read simply "depressive for 12 months, triggered by drunk and smoking ice…." The use of ketamine for a patient with a history of methamphetamine ("Ice") use required special consideration, but there is no documentation of the risks or follow-up.
Patient T, a woman in her 70s, date of birth unknown, was prescribed ketamine on 15 December and was provided with 12 x1mL syringes. A further 15 syringes were provided, and a further 24 vials were prescribed on 23 January 2015. This patient had a long history of depression and had been treated by a psychiatrist.
In respect of the treatment of all 21 patients, Dr Nespolon considered that the Practitioner's conduct fell below the requisite standard and that it warranted strong criticism. Each patient is considered later in this decision.
The records of other patients were considered. In respect of one patient it was noted that following an administration of an injection, there appeared to be a deterioration in his psychiatric condition. Yet there was no record of any treatment plan, nor follow-up on the patient's condition. The record keeping was below standard and invited strong criticism. Also, the consent for treatment was below standard and invited strong criticism.
The prescription of a Sch 8 drug for longer than two months without authority under s 28 of the PTGA was also considered to be below the requisite standard and warranted strong criticism.
[15]
Evidence of Respondent
The Practitioner admits that he is guilty of unsatisfactory professional conduct in regard to Complaint One. The particulars to the complaint record the specific matters alleged. Some of the issues raised in the complaint are admitted but others are denied. In respect of the denied particulars to Complaint One, the Tribunal has heard the evidence of the Practitioner in respect of his conduct towards patients between November 2014 and August 2015 at the clinic. While the Clinic closed in May 2015, the Practitioner continued to work in the nearby AMI offices and wrote prescriptions for a number of patients up to August 2015.
The Practitioner maintained that the period of each consultation was approximately 20 to 30 minutes. Most of the patients were self-referred. The Practitioner states that he would obtain a history from the patient and ask questions of them according to the DSM 5 (2013) criteria for depression. He stated that all the patients had self-evaluated K 10 depression scale prior to the consultation. The Practitioner stated that he documented the patient's history and "detailed treatment, especially the antidepressants using printed forms and simplified history items." He stated that he took the blood pressure and pulse and assessed the cardio-vascular risk and other risks. He states that when he was satisfied that a diagnosis of depression was appropriate and the severity was confirmed, he had a discussion with the patient in relation to ketamine and its possible side-effects and informed them that it was a novel, new treatment not approved by the TGA; that there was current research on such treatment mainly from the Black Dog Institute's trial data (from 2014) and ketamine clinical trial data from the USA. He stated he explained the side effects such as temporary blood pressure rise and dissociation. The patient was advised not to drive for four to six hours after the treatment.
The Practitioner stated that all patients had regular follow-up with K-10 and MADRS standardised assessment tools.
The Practitioner stated that it was standard procedure to ask each patient the name of both their general practitioner and current psychiatrist. On some occasions the patient did not wish to reveal the name of their psychiatrist. He stated that he contacted the patient's general practitioners and psychiatrist on six occasions. He stated that in accordance with Dr Barrett's procedure, once a patient commenced the treatment he would inform the patient's general practitioner, if granted permission to do so by the patient.
The Practitioner stated that the Clinic closed on 30 May 2015 but he remained employed until early August. He stated that he has been unable to access the patients' medical records. He stated that he would assess whether the patient was a suitable candidate for ketamine, and that he found 93 patients were suitable. There are no records of the patients who were deemed not suitable for ketamine. He acknowledged that ketamine was the only treatment provided at the clinic and stated that it was never a multi-disciplinary clinic.
The Practitioner stated that he relied upon an oral protocol provided to him by Dr Barrett when he visited Melbourne for two days to obtain instruction on the use of ketamine. There was no written protocol. He agreed that it was not appropriate to have relied strictly upon the protocol and that he should have made his own enquiries and that in consequence, he put patient's lives at risk. He acknowledged that of the patients he treated, only 14 of those patients' general practitioners were contacted, sometimes after the treatment had commenced.
The Practitioner acknowledged that the allocated consultation period was inadequate to obtain the full patient history, their existing treatment and past treatments, details of medication and of their condition. He also acknowledged that the tests upon which he relied, the answers which were provided by the patients in their K10 and MADRS responses, did not give any consideration to other psychiatric and general medical conditions from which the patient may be suffering, such as a bipolar condition. The Practitioner acknowledged that with hindsight there was not enough time to take a full history and this time pressure meant he was very busy. However he maintained that no patient was put at risk.
The Practitioner agreed that the patient had no choice in medication and that only ketamine could be supplied. He acknowledged there was commercial pressure. He acknowledged that he could not arrange for any investigations, such as blood tests, and could only write prescriptions for ketamine. He did not know the expiry date of the injection for home use even though 24 doses were usually provided and, in several cases, these were provided for use by the patient at home. When a patient revisited for further injections after the first consultation, such injections were usually provided and / or administered by a nurse.
The Practitioner acknowledged that it would have been preferable for a psychiatrist to have undertaken such assessments of vulnerable patients, yet he still maintained that he assessed the patients properly.
The Practitioner did not appear to consider that any risk existed in providing such treatment to Patient S who had been using methamphetamine.
[16]
Consideration of specific particulars
Dr Chen admitted certain particulars but disputed others. The Panel states hereunder each of the particulars in dispute and its findings. For convenience, the Practitioner's reply in summarised form follows the particular of each complaint. The full reply is contained later in this decision.
[17]
Particular 1:
The Respondent admits Particular 1.
[18]
Particular 2: Failed to conduct an appropriate assessment when he prescribed ketamine for depression
Dr Chen stated that a patient's first consultation was a 20-30 minute consultation. Dr Chen said that he was very busy and "was overwhelmed". He said that he saw roughly 20-25 patients per day in consultation.
Dr Chen stated that the dosage of sub cutaneous ketamine was 0.5mg / kg per dose or 40mg for the average patient based on weight, but more was prescribed for two patients.
Patients informed Dr Chen of their weight until scales were purchased for the clinic sometime in January 2015.
No comprehensive past medical history was taken to identify the detail of co morbidities. There was no detailed history recorded of current medication, including dosage and when initially prescribed. Dr Chen did not take a detailed history of allergies, smoking, alcohol consumption, or drug abuse. Dr Chen did not take a detailed social history.
Dr Chen took a patient history after a self-reported K10 was completed by each patient but he failed to appreciate that these patients were self-referred and had a vested interest in receiving the treatment. Thus the results of the K10 could be potentially unreliable, particularly as he was not present to complete the K10 with the patient.
Dr Chen failed to take a targeted and detailed psychiatric history. He relied on the patient for the history. He did not seek the opinion of the patient's specialist or previous hospital discharge summaries. Dr Chen also failed to make a suicidal risk assessment on each patient.
Dr Chen's examination of each patient was inadequate, failing to perform a full cardiovascular and respiratory examination to satisfy himself that the patient had no health problems which might contraindicate ketamine treatment. Dr Chen also failed to appropriately assess comorbidities such as: possible liver abnormality in Patient B; level of control of diabetes in Patient C by having an HbA1c and BSL diary; metabolic state in Patient D by contacting the Clozapine clinic for recent assessment and pathology; adequate thyroid replacement therapy in Patient I by assessing Thyroid Function Tests.
[19]
Particular 3: Failed to exercise responsible medical judgement when he prescribed ketamine
Dr Chen admitted that "these were vulnerable patients" who had "no treatment alternatives" but he relied on the verbal instructions he was given by Professor Barrett (who was not a psychiatrist). He adopted Professor Barrett's approach to assessment and treatment, without seeking further training in the assessment and management of severe treatment-refractory depression.
Dr Chen said that he did not "have the experience or expertise to assess if Professor Barrett's treatment was appropriate" and said he "was not in a position to assess" (a patient's mental health). He then contradicted himself by saying he "assessed every patient" and decided on a patient's suitability for treatment. Dr Chen had no training or experience in Psychiatry or mental health.
Dr Chen stated that ketamine was for long standing, severe, treatment resistant depression. He said that it was not suitable for patients with Bipolar Disorder, but he had three patients on a mood stabiliser raising the possibility of Bipolar Disorder or another diagnosis falling outside the indication given by Dr Chen for ketamine treatment. Patient K was on Lithium, Patient M was on Verapamil used for mood stabilisation and Patient Q was on Epilim. Dr Chen treated Patient U who did not have severe, long standing, treatment resistant depression. Patient U had anxiety.
Dr Chen stated that ketamine was not suitable for patients with a history of psychosis or schizophrenia, but he treated Patient D who was on Clozapine and Patient L who had a "tantrum" involving presentation to hospital and the police, without further exploration of the cause. Ketamine was administered the following day.
Dr Chen stated that he did not treat patients who had a history of drug or alcohol abuse yet he treated Patient B who had a history of possible alcohol abuse, Patient E who had a history of possible opiate abuse and who had possible opioid misuse, Patient F who had substance abuse, Patient J who had possible alcohol abuse, Patient K who had possible Benzodiazepine abuse and Patient S who had a history of using Methamphetamine although Dr Chen did not take a detailed history. Patient S also consumed excessive alcohol. He had "convulsions with withdrawal". This patient was recorded as "delusion" positive. Patient S was noted as screaming prior to ketamine treatment on one occasion but ketamine was administered.
Dr Chen said that he was concerned about prescribing ketamine to patients over the age of 75 years. He gave conflicting statements saying he "did not assess in a holistic way" and in referring to patients over the age of 75 years he stated "I do not treat." Nevertheless, he did prescribe to two patients who were over the age of 75 years (Patient L and Patient T).
Dr Chen said that he was careful in making a decision to treat in a patient with a history of stroke or hypertension. Patient A had hypertension. Patient J had a stroke.
He wrote prescriptions for 24 doses of ketamine as "Graham (Professor Barrett) said initially 24." He failed to exercise his own, independent clinical judgement in regard to an individualised, dose appropriate prescription.
Dr Chen wrote repeat prescriptions at the request of the pharmacy without checking for himself if these were required. Dr Chen failed to exercise his own, independent clinical judgement. Dr Chen failed to understand the responsibility incumbent on him when prescribing, and particularly when prescribing an s 8 drug. This responsibility is heightened when using such a drug in an experimental and novel clinical setting with vulnerable patients. Dr Chen wrote prescriptions for ampules and later syringes containing 40mg of ketamine in 1ml, as below.
1. Patient A was prescribed 30 syringes with 14 treatments administered.
2. Patient B was prescribed 30 syringes with 14 treatments administered.
3. Patient C was prescribed 30 syringes with 15 treatments administered.
4. Patient D was prescribed 24 syringes with 8 treatments administered.
5. Patient E was prescribed 45 syringes with 19 treatments administered.
6. Patient F was prescribed 30 syringes with 17 treatments administered.
7. Patient G was prescribed 24 syringes with 10 treatments administered.
8. Patient H was prescribed 39 syringes with 26 treatments administered.
9. Patient I was prescribed 48 syringes with 5 treatments administered.
10. Patient J was prescribed 24 syringes with 2 treatments administered.
11. Patient K was prescribed 24 syringes with 17 treatments administered.
12. Patient L was prescribed 24 syringes with 5 treatments administered.
13. Patient M was prescribed 39 syringes with 21 treatments administered.
14. Patient N was prescribed 39 syringes with 22 treatments administered.
15. Patient O was prescribed 24 ketamine injections for a period exceeding two months.
16. Patient P was prescribed 39 syringes with 24 treatments administered.
17. Patient Q was prescribed 39 syringes with 25 treatments administered.
18. Patient R was prescribed 24 syringes with 17 treatments administered.
19. Patient S was prescribed 24 syringes with 21 treatments administered.
20. Patient T was prescribed 51 syringes with unknown treatments administered.
21. Patient U was prescribed 24 syringes with 21 treatments administered.
There was a stockpile of syringes in the Clinic which Dr Chen stated "were all taken by the PSU." He agreed that he was responsible for the prescriptions he wrote but said that "there was commercial pressure" (on him).
Prior to working at the Clinic, Dr Chen stated that he had used ketamine to sedate children for minor procedures in the emergency department. He had also seen it used for endoscopies and pain management by Professor Cousins at North Shore Private Hospital.
Dr Chen stated that he had only "become aware of ketamine being used as a drug of abuse" during his time at AMC.
Dr Chen said that as increase in demand for the treatment developed, he felt it (administrating ketamine to patients) was "unsafe in March, April 2015". Dr Chen said that he expressed his concerns to management and he wanted to leave.
Dr Chen was aware of the incorrect and potentially dangerous labelling of the syringes to be given as "IM" (intramuscular) rather than sub cutaneous injection. The incorrect labelling was evident from January to June 2015. Dr Chen did not correct the mistake. He said that it was not his responsibility. Dr Chen conceded the risk to safety if the ketamine were used intramuscularly as per the labelled instructions. He finally agreed that "I should have taken a pen to the label" to correct the potentially dangerous error.
Dr Chen failed to exercise responsible medical judgement when he prescribed to his patients as below.
1. Patient H, a 16 year old girl who presented with her mother. Dr Chen failed to consult this patient without her mother present. He made a decision to prescribe home treatment of ketamine, prescribing up to 9 syringes at a time without considering the strong family history of suicide and without documenting a suicide risk assessment. Dr Chen said, "Now I think I shouldn't treat this patient". On 20 March 2015 the patient was regressing as per her K10 score (an assessment tool to measure psychological distress but used at AMC to assess patient progress at intervals during the ketamine treatment) but Dr Chen continued treatment.
2. Patient A, a 48 year old overweight man, with hypertension, hypercholesterolaemia and an elevated BP of 150/100 on presentation, who was given ketamine. His BP was elevated at times prior to treatment but treatment was administered contrary to Dr Chen's own assertion in regard to the contraindications to treatment. The patient's K10 improved but treatment continued after the two-month treatment period that Professor Barrett had proposed.
3. Patient B, a 20 year old woman was noted to be suicidal one week prior to presentation but Dr Chen did not perform a suicide risk evaluation. Patient B had a history of chronic alcohol misuse. Dr Chen knew that ketamine could cause hepatotoxicity, but prescribed ketamine without knowing the patient's liver function. He did not request liver function tests ("LFTs") nor write to her regular GP to request that LFTs be performed prior to commencing treatment.
4. Patient C, a 30 year old man, was an insulin dependent diabetic. There was no assessment of his diabetes control, however Dr Chen stated, "I knew he was well controlled as he told me." There was no HbA1c performed and no BSL diary viewed to inform Dr Chen of this patient's diabetic control. This patient had "recurrent thoughts of suicide" but no suicide risk assessment was undertaken.
5. Patient D, a 64 year old woman, had a complex history of auto immune encephalitis, with a four-year history of subsequent depression. She had a history of seizures and was on Clozapine. She had multiple admissions to hospital and had stabbed herself causing a pneumothorax. No suicide risk assessment was performed. After eight treatments this patient had no improvement in her depression. Dr Chen admitted that this patient could have "suicided on his watch".
6. Patient E was a 58 year old with a history of current treatment for Attention Deficit Hyperactivity Disorder ("ADHD") who was taking Dexamphetamine. He reported self-harm and that he was weaning from his antidepressant. He is recorded to have taken two Endone for pain (there were no details of his pain or the frequency of Endone use). This patient was self-managing his medication raising the possibility that this patient might be abusing opioids. Dr Chen did not have this concern and did not acknowledge the risk of administering ketamine (a drug of abuse) to this patient. Patient E's blood pressure was elevated but treatment was still administered.
7. Patient F was a 42 year old female who disclosed that she used marijuana monthly raising the possibility of substance abuse. Dr Chen said that this patient was "very responsible" and he knew that she was not at risk of abusing illicit drugs.
8. Patient G was an 18 year old woman with a history of depression since 12 years of age. She had a history of suicidal ideation. She was on Ativan (a benzodiazepine) although there were no dosage details. When Patient G was seen on 6 March 2015, Dr Chen noted "depressing higher" in the written clinical record, however this conflicts with the computer notes which stated that "the patient is improving". Dr Chen had no explanation for the inconsistency in clinic records. On 3 March 2015 the Patient G was suffering from extreme fatigue but no exploration of this symptom occurred to assess if the fatigue was related to depression or ketamine treatment. There was possible evidence of self-harm with a note in the clinical record of "skin lesions on the face and arms." Dr Chen did not explore the background to these skin findings however he commented that "sometimes young people are very agitated", dismissing the possibility of self-harm in this patient.
9. Patient I was a 58 year old woman on Thyroxine but Dr Chen did not assess her current state of thyroid replacement which can adversely affect mood if abnormal. In response to Patient I being prescribed 48 ketamine injections when only 5 were administered, Dr Chen said that the issue of "misuse" had crossed his mind. He admitted that he had demonstrated poor clinical judgement
10. Patient J was a 67 year old woman who smoked and had a history of stroke. She was on Warfarin and Olanzapine. She drank three to four glasses of wine and/or beer per night suggesting possible alcohol abuse. On Dr Chen's list of contraindications to treatment, this patient should have been deemed to be inappropriate for ketamine treatment. She was noted as being suicidal on 12 December 2014 and again on 2 February 2015 but her ketamine treatment continued despite clinical indications that her mental health had declined while on ketamine treatment.
11. Patient K was a 57-year-old man living in the south of Sydney with severe depression from 2003 to 2009 as recorded by Dr Chen. He was prescribed home treatment. The patient was on Lithium which raises concern that this patient may have had bipolar disorder and may have been unsuitable for treatment according to Dr Chen's list of contraindications. This patient had ADHD and was on Xanax (a highly addictive benzodiazepine frequently abused) although the dosage was not noted. On 18 May 2015 Dr Chen notes "Lithium--→' off", the patient returned to Endep 50mg, and Cipramil was initiated (another antidepressants). Dr Chen did not explore of the possibility that the patient was self-managing his medication and that ketamine treatment was inappropriate. Ketamine prescribed for home administration in this patient had a high likelihood for abuse. Dr Chen prescribed home treatment (8 syringes) for this patient on 19 May 2015. Dr Chen said that the home medication was given at the patient's request as he lived in the South of Sydney. He said patient convenience in terms of travel to the Clinic was an important consideration in the decision to provide treatment for home administration.
12. Patient L was a 78-year-old woman who had lifelong depression. She was socially isolated and had attempted suicide. Her K10 demonstrated mild to moderate depression according to Dr Chen and therefore did not fall into the category of severe depression (his indication for ketamine treatment). This patient was on a calcium channel blocker for hypertension yet ketamine was prescribed. There was a note in her clinical record stating that she "had a tantrum" and that the police were involved, but there was no further exploration of the nature of this incident. Ketamine was administered the following day.
13. Patient M was a 35-year-old medical student who was on Verapamil, a calcium channel blocker, which Dr Chen stated was for mood stabilisation rather than hypertension (raising the possibility of a diagnosis other than depression). His MADRS indicated moderate, not severe depression. Dr Chen initiated ketamine treatment. Dr Chen stated that Patient M had a relapse so ketamine treatment was re-introduced some time later.
14. Patient N, a 43-year-old woman had home treatment prescribed (she lived two hours from the city). Patient N had an initial course of treatment even though her K10 indicated a low level of psychological distress. According to Dr Chen, after the first course of ketamine treatment, Patient N relapsed and ketamine was reintroduced. Dr Chen agreed that it was inappropriate to reintroduce ketamine and conceded that he should have referred her back to the treating psychiatrist.
15. Patient O had no assessment of suicidal risk although it was noted that she had many suicidal thoughts. She had 24 injections despite her MADRS indicating mild depression. There is no record of any physical examination despite being admitted four times and having had two courses of ECT. There are no dates or reasons for the admission. The Patient was consuming Zoloft and Valdoxen, an unusual combination, but there is no comment by the Practitioner.
16. Patient P was a 32-year-old man who had Post Traumatic Stress Disorder ("PTSD"), not depression. Home treatment was prescribed for Patient P because he lived in the ACT. He had an initial course of treatment (24 injections). Ketamine treatment was reintroduced on 3 June 2015, two to three months after the first course had been completed and after the Clinic had closed. This patient reported chest and arm twinges associated with shortness of breath at one of his visits to the clinic. His symptoms were highly suspicious of a cardiac cause but Dr Chen prescribed ketamine nonetheless. Dr Chen said that he "knows how to treat chest pain" and without any investigation or referral "I was satisfied it was not cardiac pain". Dr Chen dismissed potentially life-threatening symptoms reported by this patient without appropriate investigation.
17. Patient Q was a 66-year-old man taking Epilim (as a mood stabiliser rather than for epilepsy, according to Dr Chen) and Risperidone, raising the possibility of a diagnosis other than depression. Dr Chen failed to establish depression as the appropriate diagnosis in this patient.
18. Patient R was a 44-year-old woman who had a 12-year history of being treated with Efexor (antidepressant). Dr Chen noted that she had 2 admissions to Liverpool Hospital but the reason for admission was not documented. He prescribed home ketamine treatment as she lived in Campbelltown. Dr Chen felt it was appropriate to provide home ketamine treatment even though there was a possible history of suicide attempts and knowing the risks of ketamine in overdose.
19. Patient S was a 48-year-old man with a history of seizures who was taking Olanzapine, Lorazepam, Mirtazapine, Cipramil and Seroquel. It was noted that Patient S was given Olanzapine for "convulsions with withdrawal." Dr Chen's notes recorded that patient S used "Ice" (a methamphetamine). The details were not explored. This patient abused alcohol. On 14 April 2015 Patient S was noted to be agitated and he vomited at the clinic. He was worse after treatment and noted to be "screaming". Not only did Dr Chen state that it was contraindicated to prescribe ketamine to a patient with known drug and alcohol addictions, it was dangerous to give this patient ketamine when he was agitated, risking the potential side effects of hallucinations, disassociation and delirium.
20. Patient T was in her 70's. She was the wife of the owner of AMI. Not only was she prescribed 51 syringes of ketamine, she was prescribed ketamine after the clinic was closed. There were no clinical notes for her. Dr Chen prescribed a cream containing ketamine for analgesia on two occasions but he was unable to explain why he had prescribed the cream.
21. Patient U was a 44-year-old man who presented with anxiety, not depression. He was treated with ketamine.
Dr Chen continued to see five to six patients after the Clinic had closed and continued to prescribe ketamine until he left AMI on 5 August 2015.
Ketamine was given subcutaneously into the abdomen. Syringes were dispensed with a 25-gauge needle which Dr Chen said was roughly 2cm in length. Dr Chen admitted that due to the length of the needle, the injections could be accidentally administered intramuscularly, altering the absorption of ketamine and causing potential harm to patients self-administering for home treatment.
Dr Chen prescribed up to 9 injections for home treatment with the potential for overdose and risk of death if a patient were to use all the syringes prescribed as a bolus dose in an attempt to suicide.
Dr Chen failed to see the potential for the "on-selling" of ketamine, a drug of abuse, when dispensed for home treatment.
Dr Chen acceded to patients' wishes to have home treatment rather than using his clinical judgement about when it was, and was not, appropriate to do so.
Dr Chen failed to take clinical responsibility for his actions. He blamed others for his actions such as the Professor Barrett, the pharmacy for requesting more prescriptions, the government for giving him a provider number to practice at the clinic, the NSW Department of Health for not informing him of his obligation to apply for an Authority after 2 months of prescribing ketamine and the Pharmaceutical Services Unit for not having informed him of "the rules".
[20]
Particular 4:
1. The Respondent admits Particular 4.
[21]
Particular 5
1. The Respondent admits Particular 5.
[22]
Particular 6: The Practitioner failed to provide supervision and ongoing assessment during the course of the ketamine treatment
Dr Chen stated that ketamine was administered to his patients in the 7-8 small treatment rooms. The patients would sit in a reclining chair. The treatment rooms were in a separate area to Dr Chen's consulting room. He said that approximately 25 patients were treated in a day.
Dr Chen said "we observe them very closely" referring to the patients' post-treatment care and monitoring.
From February 2015, the registered nurses ("RNs") administered the ketamine. The RNs assessed whether the treatment should proceed after the initial treatment and monitored the patient's post-ketamine treatment.
Dr Chen said that he reviewed each patient at four weeks, six weeks and eight weeks post-treatment. He also said that all patients had K10 and MADRS assessments at four to six weeks post-treatment.
There was little evidence that Dr Chen consulted patients once they started treatment.
There was no continuous monitoring of the patients post-treatment but blood pressure, pulse rate and oximetry were checked at 15, 30 and 45 minutes post treatment. After a period of time (Dr Chen did not quantify this), Dr Chen said that the patients were discharged at 45 minutes post-ketamine administration. Dr Chen also said that if the relatives were comfortable to take a patient home, the patient would be discharged even if the heart rate were still elevated. Dr Chen discharged patients in his care without appropriate medical assessment.
Dr Chen stated that there was resuscitation equipment available at the clinic (mask, intubation equipment, intravenous fluids) in the event of patient collapse, but this equipment was located in his consulting room not in the treatment rooms where the ketamine was administered.
Dr Chen stated that he had airway management skills and could intubate in the event of an adverse reaction or outcome from ketamine administration but he could not provide evidence that he had upskilled regularly to maintain his airway management skills.
The clinic closed on 30 May 2015 but Dr Chen prescribed ketamine on 4 June 2015 for home treatment, without any supervision or monitoring.
[23]
Particular 7:
1. The Respondent admits Particular 7.
[24]
Particular 8:
1. The Respondent admits Particular 8.
[25]
Particular 9:
1. The Respondent admits Particular 9.
[26]
Particular 10 Subparagraph (c): The administration of ketamine to Patient H should have been supervised or administered by a GP
Dr Chen could not appreciate the conflict of interest of having a mother of a patient administer ketamine in home treatment to her daughter who was a minor.
Dr Chen stated that he phoned the mother every week rather than Patient H. He did not discuss progress with his patient because he said that he only had her mother's phone number. He failed to perceive that this was inadequate supervision and management of this patient.
Dr Chen did not provide an outline of the treatment Patient H was receiving to enable her treating GP to administer and supervise ketamine treatment.
Dr Chen did not contact Patient H's treating GP.
Dr Chen stated that he advised Patient H's mother to take patient H to a child psychologist, but he admitted that he did not provide a referral.
[27]
Particular 11: Failed to provide follow up and support to Patients K N Q and R when prescribed for home administration
There was no follow up support for these patients despite prescribing between 2 - 8 syringes at a time for home treatment. These patients were at risk of ketamine abuse. These patients were not monitored for adverse side effects from ketamine. This was an experimental treatment using an S8 drug. Dr Chen did not regularly contact these patients nor did he liaise with their treating medical practitioners to ensure his patients' safety and regular supervision.
There was a failure to provide any written material to patients. Such details expected to be given to patients for home administration would include information such as: injection method and sites; possible side effects; how to store syringes; how to dispose of syringes and needles; advice on checking expiry dates; emergency contact numbers. Furthermore the ketamine syringes provided for take-home use were not labelled with directions indicating the frequency of administration.
[28]
Particular 12: Failed to have proper regard to a history of methamphetamine use when prescribed to Patient S
Dr Chen said that this patient was not using "Ice" (methamphetamine) when he presented to AMC for treatment. Dr Chen failed to see the serious concern that this patient might be a drug seeker and at risk of abusing ketamine. He also dismissed the possibility that this patient may have been depressed due to a possible "Ice" addiction.
[29]
Particular 13: Inappropriately prescribed to Patient N
Dr Chen prescribed a course of ketamine to Patient N when her K10 indicated a low level of psychological distress. According to Dr Chen, after the first course of ketamine treatment, Patient N relapsed and ketamine was reintroduced. Dr Chen agreed that it was inappropriate to reintroduce ketamine and conceded that he should have referred Patient N back to her treating psychiatrist. There is no evidence that the K10 and MADRS were being used to inform her treatment
[30]
PARTICULARS OF COMPLAINT TWO
Medical records failed to adequately record:
1. Information relevant to his assessment, diagnosis and treatment progress of the patient at each visit;
2. Particulars of any clinical opinion reached; and
3. Particulars of advice &/or information given to the patient.
The medical records were scant and grossly inadequate. The records were a hybrid of Dr Chen's often illegible hand written notes and computer records, which mainly had the registered nurses contribution at the time a dose of ketamine was administered.
Dr Chen did not record a comprehensive medical history. There was no detail of a current medication list. There was no detail of a mental health assessment including a suicide risk assessment. There was no social history. There was no detailed list of drug allergies. The clinical notes did not detail drug and alcohol abuse. There was no clinical opinion or patient diagnosis recorded. There was no outline of the management plan.
Dr Chen did not record any advice and or information given to the patient.
[31]
Findings:
The Tribunal is satisfied that the particulars alleged against the Practitioner are established. The information relevant to the assessment, diagnosis and treatment progress of the patients at each visit was clearly inadequate; there are negligible particulars of a clinical opinion reached in respect of each patient; there is insufficient particulars provided in the notes to know whether any advice or information was provided to the patient.
The Practitioner has admitted that he prescribed ketamine for a purpose that did not accord with the recognised therapeutic standard of what is appropriate, contrary to cl 79 of the PTGR; that he failed to communicate and to advise and liaise with treating practitioners of several patients and failed to provided treatment summary for most of the patients. The Practitioner acknowledges he acted without proper authority under the PTG Act as required by s 28(2)(a) when he prescribed ketamine; that he used a consent form in respect of many patients which did not contain the relevant information or sufficient information for the patient; that he failed to obtain proper informed consent.
The Practitioner denied that he failed to provide proper supervision and ongoing assessment during the treatment of several patients; that in respect of Patient A, the treatment should have been provided by a general practitioner; that he failed to provide follow-up support for four patients when providing them with takeaway doses of ketamine; that he failed to have proper regard to the history of methamphetamine use in respect of one patient; that he inappropriately prescribed such drug to a patient in circumstances where there is no evidence that the K10 test or the MADRS test was being used to inform the treatment.
The Tribunal finds that each of the complaints particulars which are denied by the Practitioner are established. The Tribunal also finds that the particulars to each complaint are established.
[32]
Directions
The Tribunal makes the following findings and directions:
1. The Tribunal finds that the complaints should be upheld. The Tribunal finds that the Practitioner is guilty of unsatisfactory professional conduct as alleged in Complaints One and Two of such an extent that it constitutes professional misconduct as alleged in Complaint Three.
2. The Tribunal directs that the hearing of the proceedings be continued on 24 and 25 July 2018.
[33]
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
DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated.
Decision last updated: 17 May 2018