Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Epstein (No 2) [2015] NSWCATOD 36 Hearing dates: 16 April 2015 Date of orders: 23 April 2015 Decision date: 23 April 2015 Jurisdiction: Occupational Division Before: J Boland ADCJ (Deputy President) Professor D Chisholm AO (Professional Member) Dr K Ilbery (Professional Member) A Gray (Lay Member) Decision: 1. The Registrar, Occupational Division, NSW Civil and Administrative Tribunal is requested as soon as practicable to notify the Medical Council of NSW of the following orders and conditions. 2. The conditions imposed on Dr Julie Epstein's (the practitioner) registration on 10 July 2010 as varied on 10 December 2010 and further varied on 8 May 2012 are discharged. 3. The following order and practice conditions shall be recorded on the register of health practitioners maintained by the Australian Health Practitioner Regulation Agency (AHPRA) in respect of the practitioner: (1) The practitioner is reprimanded. (2) The practitioner shall not on and after 23 April 2015 for a period of two years prescribe or dispense to any new or existing male patient the following drugs: (a) Human growth hormone; (b) Testosterone; (c) Chorionic Gonadotropin (Pregnyl); (d) Anastrozole (Arimidex or its pharmacological equivalent); (e) Other anabolic/androgenic steroids (except DHEA) and/or (f) Nandrolone Deconate (Deca-Durabolin) UNLESS: (g) she first obtains written approval to prescribe as proposed from an Australian endocrinologist of her choice who is a currently practising Fellow of the Royal Australian College of Physicians who has reviewed the patient records and the practitioner's proposed treatment plan (that shall include proposed drugs to be prescribed); OR the patient is by reviewed the endocrinologist and the practitioner's treatment plan is approved by the endocrinologist. (h) The endocrinologist/s is referred to in (g) nominated by the practitioner is to be approved by the Medical Council of New South Wales (the Council). (3) To ensure compliance with Condition (2) the practitioner shall keep a copy of any approval by the endocrinologist of her prescribing and treatment plan for the patient in the relevant patient's records, and shall maintain a log listing all patients for whom the practitioner has prescribed or treated the patient with the drugs listed in Condition 2. The log is to include: (a) the full name and date of birth of the patient; (b) the name of the approved endocrinologist who approved the practitioner's proposed prescribing and treatment plan; (c) the medication plan (including the drug(s) prescribed); (d) whether the practitioner administered the drug(s); (e) a notation that the patient: (i) has received a copy of the Consumer Medicines Information (CMI) as required by the Therapeutic Goods Administration (TGA)or in the absence of a CMI, the product information (PI) sheet for all drugs included in the treatment plan, and (ii) is aware and has understood whether the drug(s) are being used off-label (i.e. not for their TGA purposes) and that there may be as yet unknown side effects or adverse reactions for the drug(s) in the treatment plan. (4) The practitioner is to forward to the Council within three months of the date of the decision and each three months thereafter during the operation of condition 2: (a) copies of any written approval from the endocrinologist/s referred to in Conditions (2) and (3)and (b) a copy of the log referred to in Condition (3). (5) The practitioner is to submit to two audits at her premises of a selection of her records for male patients seen after 23 April 2015 by a person nominated by the Council. The first audit is to occur within six months of the date of this decision and a second audit is to occur within 18 months of the date of this decision. (6) The auditor shall be requested to assess the practitioner's compliance with compliance with these conditions and the auditor should pay particular attention to the prescribing, supplying and administration of the drug(s) listed in condition (2) and the information provided by the practitioner in her logs. (7) The practitioner is to authorise the auditor to provide the Council with a report on his/her/their findings . (8) The practitioner is to meet all expenses associated with the approval process set out in conditions (2) and (3) and the audit. (9) IT IS NOTED THAT the purpose of the audit is to assess compliance with conditions (2) and (3). (10) The practitioner may if she deems it appropriate to do so request the Council to review conditions (2) to (8) on or after 23 April 2016 (the review date). Notwithstanding the review date the practitioner may request an earlier review and any earlier review shall be at the discretion of the Council. (11) Within 28 days of 23 April 2015 the practitioner shall submit to the Council the name and professional address of a registered medical practitioner, other than Dr Ross Walker or Dr Adrian Zentner who has agreed to act as her professional mentor for approval by the Council in accordance with the Council's compliance policy "Mentoring" (as varied from time to time). (12) Each meeting of the practitioner and her mentor is to include: (a) discussion of the practitioner's professional development and collaboration with professional colleagues; (b) medical practice issues highlighted in the Tribunal's reasons for decision published on 30 March 2015 and 23 April 2015 as well as any other medical or ethical practice issues as they arise. (13) The practitioner shall authorise the Council to provide any proposed and approved mentors with a copy of the Tribunal's reasons for decision dated 30 April 2015 and 22 April 2015 together with any other material deemed relevant by the Council. (14) The mentoring arrangement shall be for a period of twenty four (24) months and shall commence within one calendar month of approval of the mentor by the Council. (15) The practitioner shall authorise the mentor to provide any report which the Council may require to the Council. (16) In the event that the approved mentor is no longer willing or able to provide the mentoring required, the practitioner must within 21 days of the cessation of the original mentoring arrangement provide in writing to the Council details of a replacement mentor (the substitute mentor) to be approved by the Council. The requirements for the practitioner's mentoring for the substitute mentor and the practitioner shall be identical to those prescribed in conditions 11 to 15 of these conditions. (17) The practitioner shall request the Royal Australian College of Physicians (the College) to include in its annual audit process a bi-annual audit of the practitioner's continuing mandatory professional development obligations during the period from April 2015 to April 2019 and the practitioner shall authorise and request the College to provide a copy of any audit report to the Council. (18) The practitioner shall within 6 months of 23 April 2015 enrol in and complete a course in depression assessment tools available on-line by Black Dog Institute or Beyond Blue and provide evidence in writing to the Council of her successful completion of the course. (19) In the event that an on-line course is not offered by Black Dog or Beyond Blue in the relevant period then the practitioner shall enrol in and complete such other course in depression assessment tools or like course as may be nominated by the Council. (20) The practitioner shall authorise and consent to any exchange of information between the Medical Council of NSW and Medicare Australia and Pharmaceutical Services for the purpose of monitoring compliance with these conditions. 4.The practitioner shall pay the Health Care Complaints Commission's costs of and incidental to the proceedings as agreed. Failing agreement application may be made to the Tribunal. Catchwords: ADMINISTRATIVE LAW – Civil and Administrative Tribunal Act 2013 (NSW). Where practitioner has been found guilty of unsatisfactory professional conduct and professional misconduct – where HCCC seeks orders that the practitioner's registration be cancelled. HELD – practitioner not unfit to practice at the date of hearing; that she should be reprimanded and conditions placed on her registration. Legislation Cited: Health Practitioner Regulation National Law Cases Cited: Clyne v NSW Bar Association [1960] HCA 40; 104 CLR 186 Dawson v Law Society of New South Wales [1989] NSWCA 58 Director-General Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523 Ex Parte Tziniolos (1996) 67 SR (NSW) 488 HCCC v Ameisen [2009] NSWMT 0 HCCC V Do [2014] NSWCA 307 HCCC v Fiay NSWMT (31 August 2012) HCCC v Fox NSWMT 19 December 2008 HCCC v Harris [2008] NSWMT 6 HCCC v Kalokerinos NSWMT 9 May 2007 HCCC v Karalasingham [2007] NSWCA 267 HCCC v King [2011] NSWCA 353 HCCC v King [2013] NSWMT 9 HCCC v Litchfield (1997) 41 NSWLR 630 HCCC v Philipiah [2013] NSWCA 342 HCCC v Wong [2010] NSWMT 4 Ohn v Walton (1995) 36 NSWLR 77 The Council of the New South Wales Bar Association v Franklin (No 2) NSWCA 428 Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Dr Julie Epstein (Respondent) Representation: Counsel: Ms K Eastman SC (Applicant) Mr P Greenwood SC with Ms C Melis (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Dibbs Crowther (Respondent) File Number(s): 1420064 dECISION Introduction 1. On 30 March 2015 the Tribunal published its reasons for decision in respect of an amended complaint referred by the Health Care Complaints Commission (HCCC) to the Tribunal in respect of Dr Julie Epstein (the practitioner). 2. The Tribunal found that the complaints asserting unsatisfactory professional conduct and professional misconduct within the meanings ascribed to such conduct under s 139B (1) (a), (b) and (l) and s 139E of the Health Practitioner Regulation National Law (the National Law) established to the requisite civil standard. 3. At the commencement of the substantive hearing, the Tribunal agreed with the parties' proposal that the hearing should be conducted in two stages in accordance with the principles enunciated in HCCC v King [2011] NSWCA 353. Directions were made on 30 March 2015 for the parties to file and serve written submissions in respect of appropriate protective orders and costs by 13 April 2015 and the matter was listed for further hearing on 16 April 2015. 4. In its written and oral submissions the HCCC seeks the Tribunal make orders cancelling the practitioner's registration, and that a period of three years elapse before the practitioner may again apply under s 163A of the National Law to be re-instated to the register of practitioners maintained by the Australian Health Practitioner Regulation Agency (AHPRA). 5. While the practitioner accepts the findings and reasons of the Tribunal, it is her position that her present practice of medicine does not pose any risk to the health and safety of the public. She explains, as she did at the substantive hearing, that the practices she now adopts, and has adopted since 2010 when conditions were placed on her registration, have resulted in substantial changes to the way in which she treats and manages her patients. Accordingly, she submits that the Tribunal should not cancel her registration. She concedes a reprimand would be appropriate given the serious findings made by the Tribunal. Her primary position is that it is unnecessary for any conditions to be imposed on her registration. However, she acknowledges the Tribunal could make her registration subject to practice conditions. 6. The Tribunal determined that the practitioner's registration should not be cancelled. However, we determined, given the serious nature of our findings set out in our substantive reasons, that the practitioner should be reprimanded, with the reprimand appearing on her registration, and that a number of practices conditions should be imposed. We also found the practitioner should pay the costs of and incidental to the proceedings. 7. These are our reasons for the protective and costs orders made. These reasons should be read in conjunction with our reasons published on 30 March 2015. Protective orders – relevant provisions of the National Law and legal principles 1. These proceedings were instituted in the Medical Tribunal of NSW prior to 1 January 2014 when this Tribunal commenced operation. The relevant law to be applied is the National Law in force as at 31 December 2014. 2. The relevant provisions of the National Law for this Stage 2 hearing are s 149, s 149A (1) (a)- (f); s 149B s 149 C (1),(2), (3), (5), and (7). 3. Section 149 provides that the Tribunal may exercise any power under Sub-division 6 of Part 8 of the National Law if, as is the case in this matter, it finds the subject matter of the complaint against the practitioner to have been proved. 4. Section 149A (1) provides as follows: 149A General powers to caution, reprimand, counsel etc [NSW] (1) The Tribunal may do any one or more of the following in relation to the registered health practitioner-- (a) caution or reprimand the practitioner; (b) impose the conditions it considers appropriate on the practitioner's registration; (c) order the practitioner to seek and undergo medical or psychiatric treatment or counselling (including, but not limited to, psychological counselling); (d) order the practitioner to complete an educational course specified by the Tribunal; (e) order the practitioner to report on the practitioner's practice at the times, in the way and to the persons specified by the Tribunal; (f) order the practitioner to seek and take advice, in relation to the management of the practitioner's practice, from persons specified by the Tribunal. … 1. Section 149B deals with the power to impose a fine. It provides as follows: 149B Power to fine registered health practitioner in certain cases [NSW] (1) The Tribunal may by order impose a fine on the registered health practitioner of an amount of not more than 250 penalty units. (2) A fine is not to be imposed unless-- (a) the Tribunal finds the registered health practitioner to have been guilty of unsatisfactory professional conduct or professional misconduct; and (b) the Tribunal is satisfied there is no other order, or combination of orders, that is appropriate in the public interest. (3) A fine is not to be imposed if a fine or other penalty has already been imposed by a court in respect of the conduct. (4) A fine must be paid within the time specified in the order imposing the fine and must be paid to the Council for the health profession. 1. We observe neither party submitted we should impose a fine in this case. 2. In light of the orders sought by the HCCC s 149C is relevant. It provides: 149C Tribunal may suspend or cancel registration in certain cases [NSW] (1) The Tribunal may suspend a registered health practitioner's registration for a specified period or cancel the registered health practitioner's registration if the Tribunal is satisfied-- (a) the practitioner is not competent to practise the practitioner's profession; or (b) the practitioner is guilty of professional misconduct; or (c) the practitioner has been convicted of or made the subject of a criminal finding for an offence, either in or outside this jurisdiction, and the circumstances of the offence render the practitioner unfit in the public interest to practise the practitioner's profession; or (d) the practitioner is not a suitable person for registration in the practitioner's profession. … (3)The Tribunal must cancel a registered health practitioner's or student's registration if the Tribunal is satisfied the practitioner or student has contravened a critical compliance order or condition. … (5) If the Tribunal suspends or cancels a registered health practitioner's or student's registration and it is satisfied the person poses a substantial risk to the health of members of the public, it may by order (a "prohibition order") do any one or more of the following-- (a) prohibit the person from providing health services or specified health services for the period specified in the order or permanently; (b) place specified conditions on the provision of health services or specified health services by the person for the period specified in the order or permanently. Section 10AK(1)) of the Public Health Act 1991 provides that it is an offence for a person to provide a health service in contravention of a prohibition order … (7) An order may also provide that an application for review of the order under Division 8 may not be made until after a specified time. 1. As we noted at [30] of our substantive reasons, we commence by reiterating the principle that protective orders made at the conclusion of disciplinary proceedings are not intended to punish the practitioner but their principal purpose is to protect the public. This objective is clearly set out in s 3A of the National Law, a NSW provision. (see also Clyne v NSW Bar Association [1960] HCA 40; 104 CLR 186). 2. Protective orders also fulfil other functions. These other functions are eloquently explained by Meagher JA (with whom Basten and Emmett JJA agreed), in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35] as follows: The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise. 1. In determining the appropriate protective orders, the Tribunal's discretion, which must be exercised judicially, is broad. A finding of professional misconduct may result in cancellation or suspension of a practitioner's registration, but this is not the automatic result of such a finding given the discretionary nature of the language in s 149C of the National Law. Other orders which may be appropriate include those set out in s 149A which include powers to caution or reprimand, to impose conditions on the practitioner's registration, to require a practitioner to undergo specified educational course, and/or to seek and take advice concerning the management of the practitioner's practice. In specified circumstances the Tribunal may impose a fine on the practitioner (s 149B). The range of orders which may be made in the exercise of the Tribunal's discretion are explained by Basten JA in HCCC v Karalasingham [2007] NSWCA 267 at [67]. 2. The Tribunal is guided in the exercise of its discretion by the principles discussed by the Court of Appeal in HCCC v Litchfield (1997) 41 NSWLR 630 and the application of the principles to its factual findings. In HCCC v Litchfield the Court (Gleeson CJ, Meagher and Handley JJA) in commenting on the findings of the Tribunal that two complaints subject of the appeal "were relatively minor matters" said: The gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from proper standards. If this is not done there is a risk that the conduct of the delinquents in a profession will indirectly establish the standards applied by the Tribunal. 1. In considering whether its finding of professional misconduct requires cancellation or suspension of a practitioner's registration, the Tribunal must be satisfied that the practitioner is unfit to practice at the date of hearing (see HCCC v King [2013] NSWMT 9 ). 2. In assessing a practitioner's fitness to practice the fact that there has been a significant period of time since the complaint period (in this case in excess of six years) does not of itself lead to an assumption that the practitioner is a reformed person. Factors relevant to consideration of reformation of character include, but are not limited to, admissions of guilt and expressions of contrition (see Ex Parte Tziniolos (1996) 67 SR (NSW) 448 per Walsh JA at p461). 3. While disciplinary proceedings frequently result in emotional and financial stress to the practitioner concerned, and may be perceived as having a punitive effect, that is not the intended purpose of the orders. The orders to be made are focused squarely on the protection of the public, maintenance of professional standards and to deter like conduct. However, it is to be borne in mind that the "punitive" element may "have opened the eyes of the individual concerned to the seriousness of his or her conduct so as to diminish significantly the likelihood of its repetition" (see Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523 at [83] per Basten JA). 4. There is no dispute that the HCCC carry the burden of proof in respect of the facts pleaded in the complaint, and it is incumbent on a practitioner in a re-instatement application to demonstrate that he or she is a person of reformed character, particularly where there has been a criminal conviction, or other serious deficiencies of character or practices found by the Tribunal (see The Council of the New South Wales Bar Association v Franklin (No 2) NSWCA 428). The principles concerning reformation of character are also relevant to the weighing of evidence of the practitioner to assess his or her level of insight and contrition for past actions when considering appropriate protective orders. The parties' submissions 1. We commence our discussion of the parties' respective submissions by acknowledging the very helpful nature of those comprehensive submissions which have assisted our task in this complex matter, and for which we express our thanks. The submissions made on behalf of the HCCC 1. After referring to the relevant provisions of the National Law, and authorities, the HCCC submit the following criteria are matters to be weighed in the exercise of our discretion to cancel the practitioner's registration (or we would say) to make other suitable protective orders: 1. the seriousness and extent of the misconduct; 2. whether the practitioner made any admissions and when the admissions were made; 3. whether the practitioner has expressed any remorse; 4. whether the practitioner has insight and accepted responsibility for her actions; and 5. whether there is a risk of the practitioner repeating the conduct in issue or reoffending. 1. The HCCC submit, referring to our findings in our substantive reasons at [715], that the practitioner's conduct is of the most serious kind. At [715] we said: We are satisfied that the practitioner's unsatisfactory conduct in respect of this cohort of patients was serious. While the practitioner asserts no patient has complained or been injured as a result of the treatment, that is not the test. What is relevant is the nature of her conduct, its potential to place the public at risk, and that it constituted a serious departure in many respects from the appropriate standard of care to be expected of a practitioner of this doctor's specialist training and long experience. The breaches by the practitioner of the relevant regulations and codes were numerous. Those matters coupled with her failure to report to referring doctors, placed her patients at risk of adverse outcomes. We are satisfied the serious nature of her conduct, based on our findings in respect of unsatisfactory professional conduct, constitutes professional misconduct within the meaning set out in the National Law. 1. The submissions go on to note that the practitioner's conduct, as found by us, was not isolated, or limited to one drug, but continued over a period of time and all prescriptions related to the complaint were "off label". The submissions point to the vulnerability of some patients, that some patients, including in particular Patient BA, may have not understood the nature of the treatment they were receiving, and that patients sought out the practitioner who acquiesced in their demands. The submissions also refer to our findings about Patient K, and the practitioner's rationale for treating this patient. 2. The HCCC further assert the practitioner's oral evidence in the Stage 1 proceedings displayed her naivety about drug seeking behaviours, and that her failure to heed "alarm bells" was apparent. The submissions also refer to the fact that we found the practitioner did not have the skills or experience to manage detoxification or "wash out" of steroid abusers. It is also asserted that the practitioner was naïve or reckless about the drugs making their way onto the black market in circumstances where the relevant patients included a patient under house arrest for importing anabolic steroids or had "bikie connections". 3. Reference is also made to our findings at [681] of the substantive reasons where we expressed, in a summary way, our findings in respect of particular 9 of the complaint which asserted the practitioner failed to conduct adequate investigations of her patients prior to prescribing (a particular admitted in part by the practitioner). 4. The HCCC also rely on and point to the fact that during the relevant period the practitioner ignored or disregarded the Department of Health publications. It is pointed out that the practitioner relied on subjective reporting of her patients to justify prescribing, was selective in her use of pathology reports, did not have proper treatment plans for her patients, nor did she follow up with the patient's referring doctors or other treating practitioners when appropriate to do so. 5. The HCCC also highlight that the practitioner's conduct occurred against a background in which she worked in an "isolated solo practice without the support of other professional colleagues". 6. Under the heading "Relevance of the admissions" the HCCC note, as did we, that the practitioner made no relevant admissions prior to the commencement of the hearing. It is also noted that the practitioner sought to challenge the HCCC's expert, Dr Conway's approach, and did not make any admissions after the six days of the experts' concurrent evidence. It is further noted that on day 7 of the hearing the practitioner was provided with an opportunity to confer with her legal advisors, and thereafter on day 8 made very limited admissions. It is noted that other admissions were made late in the day in response to questions asked by Professor Chisholm. It is suggested that admissions were only made when the practitioner's position became "untenable". 7. At [21] the HCCC's submissions address the question of the likelihood of the practitioner re-offending as follows: The late admissions must also raise a real concern about the Respondent's risk for reoffending. If the Respondent was only prepared to make the admissions because her stance was indefensible, rather than making the admission because she accepted the deficiencies in her practice, then the Tribunal may question whether the admissions were opportunistic rather than genuine. 1. In dealing with the evidence in respect of the practitioner's contrition and responsibility for her actions the HCCC refer to the decision of Mahoney and Meagher JJA in Dawson v Law Society of New South Wales [1989] NSWCA 58 where their Honours at pp 6-7 said: Repentance is relevant, at least in the ordinary case, because it assists the conclusion that the applicant has left his previous standards or values and adopted more appropriate ones. Without that, his conduct in the future is unlikely to be acceptable. 1. The HCCC submit that the practitioner did not express any regret or contrition with respect to her treatment of the patients. It is also submitted she did not acknowledge any wrong doing. 2. Central to the HCCC's submission is the proposition that our focus in making protective orders should be directed to the likelihood of recidivism on the part of the practitioner. In determining this likelihood, the HCCC submit we should assess "whether the practitioner has addressed and remedied the personal and circumstantial factors which led to the misconduct". At [30] the submissions assert: The Commission submits that there is no reliable evidence before the Tribunal that shows the Respondent's attitude or approach to her practice has in fact changed. She has made "cosmetic" changes to her practice. However even these claimed changes were belied by her evidence before the Tribunal which demonstrated that [she] still clings to many of her old views and beliefs regarding her prescribing practices. 1. Reference is made to the testimonials relied on by the practitioner. It is submitted by the HCCC that these testimonials reveal that the practitioner's practice "appears not to have changed". It is pointed out the majority of the testimonials are from male patients who are treated for similar conditions to those in the cohort of patients named in the schedule to the complaint, and that the practitioner continues to use the same drugs and combination of drugs (testosterone and HGH), that she treats patients who live interstate or in distant locations, and in the case of one patient conducts consultations by telephone with an annual face to face consultation. 2. The HCCC identify various asserted risk factors if the practitioner's registration is not cancelled. These include her historical failure to heed the warnings of the PSB officers in 2007 and 2009, an asserted lack of understanding of her obligations with respect to prescribing Schedule 4 restricted substances on the Poisons List, an asserted lack of understanding and ability to deal with drug seeking patients, poor dispensing practices, poor record keeping with lack of improvement, and her professional isolation, It is also submitted that: g. the Tribunal could not be confident that the Respondent has an appropriate level of understanding of the interactions, indications, contraindications and adverse side effects of many of the drugs prescribed; h. the Respondent remains professionally isolated; and i. the Respondent acknowledges that the use of hormones in anti-ageing is controversial but appears to refuse to accept the lack of sound evidence of any benefits of hormone replacement therapy in persons other than the elderly. 1. Further submissions address the audits conducted pursuant to the conditions on the practitioner's registration with the general assertion that the audit reports "demonstrate that there has been no significant change in the [practitioner's] patient cohort or the nature of her practice since the concerns about her prescribing which led to this inquiry were raised". Accordingly, it is submitted we would be "gravely concerned" about the risk of recurrence should the practitioner be allowed to continue practice. 2. The HCCC's submissions also address the question of the practitioner's insight (or lack thereof). At [41] the submissions set out the characteristics of insight in the following way: Insight is the acceptance of the misconduct, and a genuine appreciation of why the conduct was wrong and harmful. It involves self-reflection as to the reasons why the conduct occurred, and the personal weaknesses which lead to the conduct. It involves personal acceptance and responsibility for the conduct and then addressing these matters to demonstrate objective change 1. It is submitted that the practitioner's refusal to make concessions until pressed and her words and conduct did not demonstrate any willingness to take appropriate measures to minimise the risk of recurrence. Reference is made to the practitioner's asserted naivety, lack of rigor before implementing treatment, or appreciation of her patients' psychological vulnerabilities. 2. The HCCC's submissions at [50] and [51] raise two issues. The HCCC submits: The Commission notes that the Respondent has not adduced any evidence in the form of character references or observations of how the Respondent's practice has changed or whether she had gained insight from professional colleagues. There are no references from any practitioners specifically identified in the anti-ageing field - including the overseas colleagues of the associations that the Respondent has joined. In 2009, the Respondent claimed that she was being mentored by Professor Stephen Leeder. There is no evidence from him about the nature and extent of any mentoring. Generally, the Tribunal would expect a mentor of the standing of Professor Leeder to give evidence of the changes he observed during the mentoring relationship and comment on whether the Respondent had developed a greater understanding or awareness of the conduct that caused her to come to the PBS and Medical Council's attention. There is no evidence of this kind. The Tribunal may draw the usual inference that the absence of such evidence means that Professor Leeder's evidence would not have assisted the Respondent. 1. Finally it is submitted that we should disregard the patient statements, or afford those statements very little weight. 2. Submissions in reply to the practitioner's submissions were received by the Tribunal on 15 April 2015. It is unnecessary in our reasons we refer to the two apparent areas of disagreement between the parties as to the correct interpretation of relevant principles to be applied when making protective orders, including the burden of proof in respect of such orders. Those disagreements were substantially overtaken by further exposition by both Ms K Eastman SC (Ms Eastman) and Mr P Greenwood SC (Mr Greenwood) in their oral submissions. 3. Both parties acknowledge a tribunal may, in an appropriate case, derive guidance from comparable cases. However, the HCCC submit that cases cited by the practitioner's counsel in support of the protective orders ignore or overlook relevant cases where a practitioner's registration has been cancelled for inappropriate prescribing. We will refer to some of the cases cited under the heading "Discussion" below. The practitioner's submissions 1. The practitioner's submissions focus on the time that has elapsed since the conduct the subject of the complaint, the steps the practitioner has taken "to change aspects of her practice since that time", and concessions she made to the Tribunal in her evidence. The submissions note that the practitioner "does wish to continue at her practice at Artarmon on a part-time basis. She intends to involve other practitioners in her decision-making and her professional life and has already begun the process of doing so". 2. Paragraphs [16] – [18] cite authorities dealing with protective orders. At [18] it is submitted: In a number of recent prescribing cases in the Tribunal where professional misconduct was established, orders other than suspension or deregistration were found by the Tribunal to be appropriate. Such orders are commonplace where the evidence demonstrates that a practitioner, although guilty of professional misconduct, can nevertheless be acknowledged to have the capacity to continue safely in practice, usually subject to appropriate conditions. Bearing in mind that each case is confined to its own facts, the cases provide some assistance to the Tribunal as a "reflection of the accumulated experience and wisdom" of other Tribunals' consideration of prescribing cases. Some examples include: HCCC v Low [2015] NSWCATOD 18 (see paragraphs 79-100 for a discussion of the relevant law and appropriate orders). HCCC v Bruna [2014] NSWCATOD 31 (see paragraph 107 and following for a discussion of appropriate protective orders). HCCCvBosnich [2012] NSWMT - 3/7/12 (see paragraph 44 and following for a discussion of orders). HCCC v Gorondy-Novak [2011] NSWMT 3 (see paragraphs 215 and following for a discussion of appropriate orders). HCCC v Zacharia [2011] NSWMT - 20/12/11 (see paragraph 234 and following for a discussion on penalty). HCCCvNguyen-Phouc [2010] NSWMT - 7/12/10 (see ppl5-22 for a discussion of appropriate protective orders). 1. The submissions go on to note that a reprimand is required to record the Tribunal's serious disapproval of the conduct found to be established at [715] of our substantive reasons (which we have set out in full earlier in these reasons). It is pointed that that the relevant conduct occurred up to 8 years previously, that there have been no complaints about the practitioner's patients or others for over 5 years and that her practice (we would say records) have been audited regularly. 2. At [23] the submissions summarise the admissions made during the course of the hearing as follows: [The practitioner] made certain admissions during the course of the hearing They are set out at paragraphs [11]-[12] of the Tribunal's decision She conceded that during the complaint period prescribing simultaneously different testosterone preparations was not warranted She conceded her record keeping was inadequate and below accepted standards as was her failure to conduct physical examinations She further conceded that for the majority of patients she did not provide reports to referring practitioners and that this too was below accepted standards She also acknowledged that regular monitoring of the patient is important and she no longer is willing to prescribe to people she does not see regularly (paragraph 338 of the Tribunal's decision) She told the Tribunal that she had changed her practice since the s 66 hearing in respect of recording keeping and that she now conducts physical examinations of all her patients She has not prescribed different testosterone preparations simultaneously since 2009 ([The practitioner's] statement, paragraph 130) She ceased using decadurabolin in 2010 ([The practitioner's] statement, paragraph 104) Since the s 66 inquiry she has been vigilant in writing letters to referring practitioners ([The practitioner's] statement, Schedule A, p20) 1. The submissions go on to note that the practitioner had a mentor for approximately 18 months after conditions were first imposed on her registration. We pause to note that the mentor reports were not included in any of the material before the Tribunal and it only came to light in the course of the Stage 2 proceedings that Professor Leeder did not assume the role of mentor, rather that role was undertaken by Dr Ross Walker, a specialist cardiologist. 2. It is also noted that the practitioner was required, pursuant to the conditions, to provide an information sheet to prospective patients to be signed by them disclosing "risks associated with off label use of human growth hormone and/or anabolic-androgenic steroids and certain other medication". It is noted that the practitioner continues to require patients to sign an information sheet prior to commencement of any treatment which is on or off label. 3. Reference is also made to the condition which required the practitioner's consent to the exchange of information between the Medical Board and Medicare Australia or the PSB where necessary to ensure compliance with the conditions. 4. At [28]-[29] it is submitted: Dr Epstein's adherence to the conditions demonstrates her capability to change her medical practice to conform with the conditions imposed and with those changes raise the standards of her practice and gain a level of insight in what she can do better to make her practice of medicine more transparent, objective and rigorous. She acknowledges that the implementation of changes to her practice have improved the overall high standard of patient care (Dr Epstein's statement, paragraph 44) It is submitted that this should give the Tribunal comfort that Dr Epstein is fit to continue to practise without conditions or otherwise that she will abide by any further conditions should they be imposed on her registration by this Tribunal A final matter for the consideration of the Tribunal in its formulation of protective orders is the impact of the investigation and prosecution on Dr Epstein It has been prolonged and significant on Dr Epstein The stress of the proceedings on her health and quality of life as well as the health and quality of life of her family is discussed at paragraphs [28]-[29] of her statement (Ex 51) The stress of these proceedings on Dr Epstein was also evident over the 7 days she spent in the witness box under cross-examination The Tribunal can be confident that the impact and effect of the disciplinary proceedings ensures Dr Epstein will not re-offend The practitioner's oral evidence and documents tendered at the Stage 2 hearing 1. At the commencement of the Stage 2 hearing no further evidence was sought to be adduced on behalf of the practitioner. Mr Greenwood told the Tribunal that the written submissions provided on behalf of the practitioner were in accordance with her instructions and could be relied on by us. However, we note that the submissions were not evidence before us, although as noted above, the submissions did reference parts of the practitioner's evidence in her statement relied on at the Stage 1 hearing. 2. The Tribunal was concerned about the lack of evidence from the mentor, Dr Ross Walker, the practitioner's proposals to overcome her apparent professional isolation, and just how (as stated by Mr Greenwood in his oral submissions) the practitioner proposed to comply with the guidelines referred to in [701] of our substantive reasons. We note at this point in time the only evidence in relation to the mentor was the practitioner's letter to the then NSW Medical Board proposing Professor Leeder as her mentor. Given the many references in the Stage 2 proceedings to the guidelines we set out in [701] of our substantive reasons we now re-produce that paragraph. We accept Dr Conway's evidence of the standards applicable to a doctor who elects to practice in the diagnosis and treatment of hormone deficiency and/or imbalance. We add to Dr Conway's standards the words "whether on- or off-label, noting the standards assume particular importance for off-label prescribing". These standard require: (1)taking a full and relevant clinical history; (2)making a physical examination of the patient; (3)obtaining relevant pathology, including repeat tests to determine whether the patient has hormone or androgen deficiency; (4)investigating symptoms beyond generalised non-specific symptoms; (5)taking appropriate steps to investigate hypothalamic-pituitary tumour; (6)taking appropriate steps to exclude underlying conditions prior to commencing treatment; (7)appropriate monitoring and ongoing review, particularly for patients with known prostate disease; elevated creatinine levels or PSA levels; (8)communication with referring GP's and other specialists; (9)being aware of the practitioner's limitations and referring patients to appropriate specialists; (10)not acceding to the patient's wishes or demand for particular treatment (we would add "unless appropriate to do so"); (11)being aware of drug seeking behaviours and to refuse treatment to anabolic abusers (we would add "and if appropriate referring such patients to a practitioner experienced in drug withdrawal and/or a psychologist"); (12)identifying and understanding relevant regulatory obligations and clinical standards; (13)treating the patient on recognised evidence based medicine (we would add "or evidence based medicine recognised by a reputable minority of the profession"); (14)keeping appropriate clinical records including treatment plans (we would add "including to record drugs and quantity dispensed on each occasion"); (15)not prescribing in excessive quantities; (16) advising patients of risks, side effects ( we would add "and costs") of treatment ("and obtaining informed consent from the patient"); and (17) discontinuing ineffective treatment. 1. In response to the Tribunal's questioning, Mr Greenwood tendered a letter dated 6 May 2010 from the practitioner to the then NSW Medical Board in which she advised Professor Leeder had declined to act as her mentor and asserted this was because of the mentoring requirements in the Board's policy Guidelines for Mentors. The practitioner proposed Dr Ross Walker, Cardiologist who had agreed to undertake the role. Dr Walker was the treating cardiologist of Patient H, the practitioner's partner; Patient H was referred to Dr Walker on 10 June 2009 by the practitioner. He also referred a number of patients to the practitioner. 2. Also tendered by Mr Greenwood was a copy of an email from Dr Walker to the Medical Council dated 18 April 2012. Dr Walker said: I am the professional mentor for [the practitioner]. I am having trouble finding the Mentor report form but can let you know that our meeting times were Friday 20/1/2012, Friday 3/3/2012 and Friday 16/3/2012. I note I have now been mentoring [the practitioner] since mid-2010. In that time, she has displayed exceptional knowledge in her field of practice, and continues to show much insight into the concerns expressed by the Medical Board. She has also reached out to other practitioners and now has an extended network with whom she regularly consults. Therefore, while I am pleased to continue in this role if needed, I do not believe there is anything further to be gained from the formal mentoring process and it is my recommendation that the conditions requiring [the practitioner] to have a formal mentor be removed, as is consistent with published policies. 1. A further tender was made without formal objection of an email from the practitioner dated 15 April 2015 (the day prior to the Stage 2 proceedings) to Associate Professor Jane Holmes-Walker, Clinical Associate Professor and Senior Staff Specialist, Dept of Diabetes and Endocrinology, Westmead Hospital and the specialist's reply. The practitioner's email is in the following terms: You may or may not know that I have been under scrutiny for my practice of Antiageing Medicine. I am reaching out to you as a colleague. I would like to put your name forward as someone I can run by patient managements etc as a resource. One of the criticisms is that I don't have Australian colleagues that I regularly talk to. I would suggest that this would not be onerous or time consuming for you. I simply ask for your support. 1. Associate Professor Holmes-Walker replied that she was "happy to assist" and queried whether the practitioner had a "couple of others you can also call on as it may help to have differing opinions to draw on". 2. Finally, the practitioner's counsel tendered and placed reliance on the practitioner's behalf on an email from Dr Adrian Zentner, a registered specialist general practitioner. Dr Zentner said that he is "happy to be available for you to call me to discuss patient management, treatment plans and case reviews". 3. Dr Zentner's curriculum vitae reveals extensive experience in the airline industry between 1983-93 including assessing the health of pilots, clearance of passengers to fly and other occupational health issues. Between 1993 and 2007 he assumed the role of Medical Director of a number of clinics. His curriculum vitae discloses that during this period he began working with a Perth based group who operate a program that "adopted a generalized approach to wellness and a preventative rather than a reactive approach to maintaining and optimizing health". On and from 2007 he re-entered general practice and states he "currently works in both GP and Occupational Medicine as well as pursing my interest in hormone therapy". 4. After the Tribunal indicated it would be assisted in its task to have the advantage of sworn evidence from the practitioner about matters relevant to her practice post 2010 and appropriate protective orders, she gave oral evidence, answered questions posed by the Tribunal members, and was cross-examined by Ms Eastman. 5. Ms Eastman noted that the practitioner's evidence was late in the day, and given without notice. We accept that submission was properly made. Notwithstanding we accept Mr Greenwood's explanation that the practitioner was reluctant to undergo further cross-examination after her extensive cross-examination in the Stage 1 proceedings, it is regrettable that the practitioner's evidence was not available earlier in a written form. Notwithstanding these matters, we found Ms Eastman's cross-examination was incisive and thorough, and overall we were satisfied both the practitioner's oral evidence as tested by cross-examination, together with the tendered documents assisted our deliberations. 6. The practitioner commenced her oral evidence by noting that she absolutely accepted the finding of the Tribunal and explained that the years of complaint period (2007-2009) had been difficult ones, that she had now had a great deal of time to reflect on her actions, and that although her practice now involved a relatively small number of patients she wanted to continue to practice with "rigor", and in accordance with the guidelines set out in [701] of the substantive reasons. 7. The practitioner confirmed and expanded the evidence in her statement to the effect that she has been attempting to improve communication with patients' referring doctors and specialists and she said she had derived benefits from such communication. She went on to explain the steps she has and proposes to take to avoid professional isolation including the fact she has become a member of the Australian Integrated Medical Association (the Association) and proposes attending the Assocation's forthcoming conference. She also indicated that she would try and attend the annual conference of the Royal Australian College of Physicians in Cairns next month and that she had joined the Functional Medicine Association. 8. The practitioner said she proposes to have a month's break from her practice, and on resumption of practice she will re-assess every current patient in accordance with the [701] guidelines, and that this re-assessment is likely to mean that she will reduce her S 4 prescribing. She said the reassessment process would give her a sense of security about her patient management. 9. The practitioner was questioned by the Tribunal members about her professional colleagues and she explained while she did currently have contact with Dr Zentner, and her overseas colleagues, that she hoped by her membership of the association she would expand her relationship with professional colleagues. 10. The practitioner was also questioned about the provision of pathology reports she obtained for patients to referring doctors. She candidly admitted that she sometimes forgot to "tick" the relevant box on the pathology report form, but acknowledged she could instruct her secretary to follow up to ensure relevant pathology reports are provided to referring doctors. 11. In answer to questions posed by Ms Eastman, the practitioner explained her re-assessment of all current patients is likely to take about six months. She stressed that, in her view, that she is able to self assess her limitations and refer patients when appropriate to do so. She acknowledged her deficiency in this regard during the complaint period in respect of the patients whose results disclosed high creatine and PSA levels. In respect of patients with the latter result she explained she would now refer to a urologist rather than adopt, as she previously had done, a "wait and see" approach. 12. The practitioner was challenged about how she would identify an anabolic seeker or anabolic users, and explained that she would conduct a thorough investigation including pathology tests, and refuse to prescribe if the patient had a suppressed IGF-1 . She also explained if the patient had a referring doctor she would speak to that doctor. 13. She was also vigorously cross-examined about her knowledge, and application of, relevant regulations. While the practitioner, who was clearly stressed by cross-examination, did not initially give specific examples she referred to a folder of regulations she had prepared, and gave examples of regulations concerning script writing, note keeping with particular reference to off label prescribing. 14. When challenged about prescribing based on evidence based medicine (as set out in [701(13)) she explained that she would be guided by appropriate literature and this would result in her treating a lesser number of patients. 15. Ms Eastman asked the practitioner to explain how she would treat a male patient who presented complaining of tiredness and erectile dysfunction. The practitioner explained she would deal with such a patient on "a patient by patient" or individual assessment by reference to published papers. She also explained that if a trial of testosterone was not helpful she would discontinue prescribing the drug. The practitioner went on to state that "a good patient history" was "a good starting point" and included ascertaining what medications the patient had or was taking, and then ordering appropriate tests. In the course of this explanation the practitioner stated that she no longer treated obese patients with growth hormone and that for such patients she would order or conduct a proper body composition scan. 16. Amongst matters the practitioner said she will implement, or would be prepared to implement, if permitted to continue practice included a prescribing course run by Monash University, and to conduct a psychiatric (depression) questionnaire for patients presenting asserting depression. She also explained by reference to one patient seen post 2010, who fell into the anabolic abuser category and whose general practitioner had prescribed anabolics, that she had put him on a washout program and after three months when he still had a suppressed IGF-1 she had refused to further prescribe. She said the patient had behaved aggressively and left her rooms. 17. The presiding member raised with the practitioner, for her reaction, her willingness to comply with a condition which would require her to refer her prescribing recommendations, treatment plan, and patient records for any new male patient to whom she proposed to prescribe growth hormone, testosterone, Pregnyl, Arimidex, and or other androgens, except DHEA, for approval to an endocrinologist of her choice prior to prescribing. The practitioner acknowledged she could be subject to such a condition, but would prefer not to have to comply with a condition of this type. 18. The practitioner was also challenged about the frequency with which she sees patients, with particular reference to a patient who lives at Grafton, and who provided a testimonial. The practitioner explained she has determined that, it is reasonable, once a patient has been properly assessed, if they are reviewed not less than six monthly.. In giving this answer the practitioner noted that a specialist seeing a thyroid patient may only see such a patient after initial treatment on annual review. 19. Significantly, Ms Eastman asked the practitioner to comment on the HCCC's submissions touching upon the absence of expressions of remorse or contrition by the practitioner. The practitioner said she did feel remorse and contrition and that she had let her standards slip in the way in which she managed patients in the period 2007-2009. She also acknowledged that she had let down her fellow professionals by not reporting to them when those professionals had referred a patient. 20. Finally, in response to questions posed by Dr Ilbery, the practitioner explained (subject to qualification of what was defined as group practice) that she would not be adverse to group practice. She did however explain that she has lease commitments in respect of her current rooms until August 2015, and that she had received an offer from a general practitioner at Mosman for a room at that practice that she was considering. Discussion and conclusions protective orders 1. It is useful that we commence our discussion by reference to two paragraphs of our substantive reasons that are not referred to in the parties' submissions in respect of appropriate protective orders as those paragraphs highlight aspects of these proceedings which were central to the dispute. At [135] and [136] we noted: In regard to the appropriateness or otherwise of the practitioner's prescribing of hormone treatments, we note, as indicated by Dr Conway, that virtually none of the prescribing indications are supported by long term randomised clinical trials of efficacy or safety, or by prescribing guidelines from national or international endocrine societies. However, there is, as documented in the references submitted on behalf of the practitioner, some short term clinical evidence for benefits, including weight and fat reduction, muscle gain, tissue repair and increased libido and sexual function with androgens, in males who do not meet clear criteria of HGH or testosterone deficiency; this could provide some rationale for an 'off-label' trial in some patients. Amongst the references submitted (and highlighted by Mr Greenwood) we gave particular weight of an editorial by Prof P Sonksen (J. Clin. Endocrinol. Metab 2013,98: 2270-73). Professor Sonksen is an acknowledged international expert in HGH therapy, who argues that prescribing outside accepted guidelines may be justifiable (for HGH) as a "trial of one" when "anthropometric, functional, psychological and biochemical baseline information" is obtained and there is careful "monitoring of measured variables, looking for benefit objectively". As we later discuss when considering the topic of unsatisfactory professional conduct and professional misconduct, the lack of adequate baseline information (particularly physical examination) and very poor documentation of measurable response parameters, as well as simultaneous introduction of two or more hormone therapies (clouding interpretations of benefit of each) and sometimes excessive doses of androgens make it difficult to find the practitioner's off-label prescribing as conforming to acceptable medical practice. We also consider that off-label prescribing as a "trial" would place more importance than usual on adequate communication with the referring or other involved practitioners, which was generally absent. 1. At [701], based substantially on Dr Conway's evidence, we referred to standards to be applied by a doctor who elects to practice in the diagnosis and treatment of hormone deficiency and/or imbalance and noted those standards assume particular importance for off-label prescribing. We note the practitioner's submissions acknowledge her agreement with the matters set out in [701]. 2. We consider it is appropriate, in the structured exercise of our discretion, that we consider the evidence before us and the submissions made having regard to the topics identified by Ms Eastman in her submissions on behalf of the HCCC, and when considering questions of risk, to assess the extent to which the practitioner's current practices meet the standards identified and found to be appropriate as set out in [701]. In the course of this exercise we will, if appropriate, be guided by other like prescribing and record keeping decisions. Relevance of admissions 1. There can be no doubt that the practitioner up to the commencement of the hearing strongly defended her prescribing practices and treatment of the cohort of patients, with the exception of Patient AS who she acknowledged with hindsight in the schedule to her statement was not genuine in seeking treatment. She initially expressed reluctance to make admissions. However, she did make a number of generalised and some specific admissions in Exhibit 13 which are summarised by us in [11]-[12] of the substantive reasons. She also, albeit when pressed by Professor Chisholm, acknowledged that her prescribing practices in respect of the use of two anabolic preparations simultaneously was inappropriate. 2. While the practitioner's reluctance to initially make any admissions may have been explicable by her professional isolation, combined with her evident belief that the disciplinary proceedings were misconceived because no patient had complained, nor was there any evidence of a documented adverse outcome, we were concerned that many admissions were made late in the day and with what we perceived to be a degree of reluctance of her part. 3. However, as set out above, the practitioner did admit that in a major respect her records were inadequate because they did not comply with the regulations, that she failed to carry out physical examinations of her patients, that significant aspects of her clinical assessments were also inadequate, and that she almost universally failed to correspond with referring practitioners or other specialists. 4. We find that the practitioner's, at least initial, reluctance to make admissions is intrinsically linked with the question of her insight which we discuss shortly. Contrition and remorse 1. While the HCCC submit in the submissions prepared prior to the Stage 2 hearing and without the knowledge that the practitioner would give oral evidence, that practitioner did not acknowledge "any wrong doing", we find that submission is too broadly asserted. As set out above the practitioner did acknowledge during the Stage 1 proceedings aspects of her conduct were wrong in that they constituted unsatisfactory professional conduct. The practitioner acknowledged she should not have prescribed two different testosterones and or testosterone and Deca-Durabolin simultaneously as this was an experiment designed to avoid a patient suffering a "crash". 2. In her oral evidence in the Stage 2 proceedings the practitioner made two significant statements on which we have placed considerable weight. First, she unequivocally acknowledged her complete acceptance of our findings in the substantive reasons. That acceptance includes the practitioner's acceptance of our finding that professional misconduct was established. She also conceded she had let her standards slip in the complaint period. She further conceded that she had let down her fellow professionals in failing to report to them about treatments instituted for mutual patients. While the practitioner did not, in her oral evidence, specifically refer to remorse in respect of her conduct as it affected her patients, we accept she inferred this in her acceptance of our findings, and her expressed contrition in failing to communicate with referring practitioners potentially to the detriment of her patients. We accept the practitioner was sincere in her expression of remorse. Responsibility for her actions 1. We commence our further discussion of this topic by noting and giving weight to the fact this practitioner has, with the exception of these proceedings, practised in excess of 36 years during without any evidence of complaints or concerns. 2. The practitioner did, in her oral evidence at the Stage 1 hearing, refer to changes in the way she conducts her practice, and that she now endeavours to practice in a more scientific manner. She acknowledged that since the s 66 proceedings, she obtains a written informed consent document from every patient whether the patient is treated with on or off label drugs, always carries out a physical examination and reports to referring practitioners. Her evidence in this respect is corroborated by the limited records for some patients she continued to treat outside the complaint period which appeared in what were described by her counsel as "the reconstituted records". Her evidence on these topics was not subject to challenge and we accept it as truthful. 3. To date, on the evidence before us, the practitioner has demonstrated responsibility by her compliance with the conditions imposed at the s 66 enquiry. 4. It was of concern to us that no reports by Dr Walker were available to us, and the comments in his email appear to have been based on statements of the practitioner. Those statements, insofar as they refer to the practitioner having "an extended network" of colleagues are, in our view, potentially misleading. We note when given the opportunity before us to name her colleagues the practitioner only named Dr Zentner and referred to unnamed colleagues from the American Anti-ageing Association. We were also concerned because it was not apparent that the Board and subsequently the Council had been notified that Dr Walker was also Patient H's treating doctor, having been referred to that specialist on 19 June 2009, some twelve months prior to the commencement of the mentoring relationship, by the practitioner. 5. We were also concerned that notwithstanding the changes which we accept the practitioner has made to her practice, she remains professionally isolated. Her recent contact with Associate Professor Holmes Walker was only instituted the day prior to the Stage 2 hearing and after the service of the HCCC's written submissions. 6. As noted above, we accept that practitioner has been responsible in complying with other practice conditions. She has ensured all patients treated off label are provided with proper information and have signed consent documentation. We also accept she has, since the conditions were imposed, conducted physical examinations of patients, improved her record keeping and reported to referring practitioners. With the exception of the dual prescribing of testosterones, a practice abandoned outside the complaint period, the practitioner's prescribed dosages were not excessive. She no longer prescribes Deca-Durabolin. On the evidence before us, no patient actually suffered an adverse outcome during the complaint period, although we accept in some cases they were at risk of doing so. 7. The HCCC also relied on the audit reports (and also the patient testimonials) to submit that the practitioner's cohort of patients has not substantially changed since the complaint period. The audit reports are now outdated, no audit having been conducted in 2014. We were not satisfied that we could consider all audit records reflected a sample audit of all patient records, although the final audit report does contain an audit of 20 patient records, two of whom were not on the medication defined in the conditions, and 6 of whom based examination of their first names, were women. Testimonials given in Exhibit 9 are from 35 patients, 3 of whom are, given their first names, female. Two testimonials from male patients refer to the practitioner treating their spouse. 8. It is regrettable that the practitioner did not provide definitive evidence of patients numbers and gender post 2010 in order that we could accurately assess the nature of her practice since that date. Doing the best we can on the evidence before us it appears that the patients are predominantly male and many have been prescribed testosterone or human growth hormone. We note however, the practitioner's concession that treatment of many of these patients may be discontinued after the practitioner's re-assessment against the guidelines referred to in [701] of the substantive reasons. It is of some concern to us, given the practitioner's evidence that she has since 2010 adopted a more scientific approach to prescribing, that it is only now after publication of our reasons, she proposes to re-assess her present cohort of patients and anticipates ceasing treatment of many of them. 9. We do not accept, however, on the evidence before us, that the practitioner's prescribing and dispensing during the complaint period, or at any time, suggests that she was knowingly dispensing anabolic steroids in excessive quantities for re-sale or potential re-sale on the black market. Certainly post 2010 there has been no complaint about the practitioner's patient care. Our assessment of the practitioner is that she is a doctor who is sympathetic to her patients and their problems, does not rush patient appointments but by reason of her trusting and somewhat vulnerable personality needs protections around her to reinforce the rigor which she expresses she wishes to enforce in patient care while she engages in off-label prescribing of anabolic steroids. Such protections in our view are necessary for some period of time if we determine she should be permitted to continue practice. 10. While we are cautious in placing any significant weight on the patient testimonials, particularly given we do not know what information was provided to the patients, or whether they are still active patients, it is relevant to note that the recurring theme in the testimonials is that the practitioner demonstrates care, sympathy and provides advice to her patients about risks associated with off label prescribing. Thus, the testimonials give some corroboration to our findings about the practitioner's personality and mode of practice. The practitioner's insight and whether there is a risk of offending or re-offending if the practitioner 's registration is not cancelled 1. In our view matters relevant to this topic lie at the heart of these Stage 2 proceedings. 2. We have already referred to the principles to be applied to determine whether or not the practitioner is presently fit to practise or whether her ongoing practice would constitute a risk to the health and safety of the public. Relevant to the latter consideration is the question of whether the practitioner's registration should be cancelled or whether conditions on the practitioner's registration are necessary. 3. We commence our discussion by reference to the effect of these proceedings on the practitioner and whether the disciplinary proceedings have affected her attitude and insight to her conduct. We accept these lengthy proceedings have been draining both emotionally and physically on the practitioner. Her demeanour in the witness box in these Stage 2 proceedings demonstrated her distress and that she was reluctant, but nevertheless submitted to further cross-examination after her lengthy cross-examination in the Stage 1 proceedings. 4. We accept the practitioner's acceptance of our findings in the Stage 1 proceedings is genuine, although made very late in the day, as is her stated intention to import rigor into her practice.. We accept, even if only after the publication of our reasons some 15 days prior to the Stage 2 proceedings, she has demonstrated a significantly increased level of insight and remorse. 5. The submissions made on behalf of the HCCC are detailed and careful. At first blush, the matters raised appear compelling and support an order for cancellation of the practitioner's registration. While matters in issue are finely balanced, we are satisfied the unique facts in this case require deeper analysis. 6. The submissions in reply of the HCCC assert that the cases referred to in the practitioner's submissions (and set out by us earlier in these reasons) are not comparable. It is noted that the practitioner's submissions failed to refer to a number of decisions where the practitioner's registration was cancelled at the conclusion of disciplinary proceedings. 7. The decisions cited by the HCCC are HCCC v Fiay NSWMT 31 August 2012, HCCC v Wong [2010] NSWMT 4; HCCC v Ameisen [2009] NSWMT 9, HCCC v Harris [2008] NSWMT 6, HCCC v Fox NSWMT 19 December 2008 and HCCC v Kalokerinos NSWMT 9 May 2007. 8. Without exhaustively setting out the facts and findings in each case cited above we note in HCCC v Fiay the Tribunal found the practitioner had prescribed benzodiazepines and other S 4 D and S 8 over a lengthy period of time, and he had poor record keeping. The Tribunal found aspects of the practitioner's evidence to be unreliable and that he had not followed through with actions promised such as undertaking an ethics course at Monash University. While there are a number of similarities to the present case, we find two distinguishing features. Those are that the Tribunal found the practitioner had given misleading evidence and at the date of the hearing was lacking insight. 9. There is no suggestion that the practitioner misled the delegates in the s 66 inquiry, or officers of the PSB and HCCC. Her oral evidence to us, albeit coming late in the day, did disclose insight and acceptance of all of the Tribunal's findings which were very critical of her conduct of her practice in respect of the cohort of named patients during the two year complaint period. 10. We also consider that the facts in this case are far removed from those in HCCC v Wong where the Tribunal recorded the doctor's lack of knowledge of the drugs he prescribed, stating he practiced with "almost no knowledge or skill". The practitioner was found to have written numerous prescriptions for drug seeking patients in large quantities, wrote prescriptions in a night club, self prescribed benzodiazepines, and had several serious driving offences involving alcohol. 11. Although the Tribunal considered the prescription by the practitioner of anabolic steroids in HCCC v Harris, the facts are materially different to the instant case. In Harris the practitioner purchased large quantities of drugs which he kept at his home and supplied to body builders without, in many instances, seeing the patient. He also self administered morphine and pethidine, and was referred to the Impaired Registrants Panel. He was subject to a number of prior complaints. We make similar comments about the facts in HCCC v Fox. In the latter case the practitioner was found to have suffered a frontal lobe dysfunction, and this was found to be a likely contributor to his deviant prescribing practising including self-prescribing. 12. In Ameisen the Tribunal found the practitioner had a history of prescribing to drug abusing patients over a considerable period of time, in some cases he knew the patient was sharing drugs with a partner, had disregarded warnings from the PSB, about his actions and lacked insight. 13. We are satisfied that the facts in HCCC v Kalokerinos are also significantly removed from the facts in this case. Not only did the practitioner inappropriately prescribe drugs of addiction, he was found to have engaged in a serious boundary violation with a 17 year old patient. The Tribunal found the practitioner's evidence to be a unreliable. It found the only order which could protect the public was the cancellation of the practitioner's registration. 14. It must be remembered that while we found in respect of a number of patients the practitioner had prescribed to known anabolic users, or had simply acceded to patients' requests for these drugs, some patients in the cohort may have been suitable patients to receive supplementation, having regard to the circumstances described in [135]-[136] of our substantive reasons. But those patients were not assessed, and treated, nor were reports made to their referring doctors or specialists in the manner described in the guidelines in [701]. In our view the latter facts put this matter in a different category to many of the prescribing cases to which we have been referred. We also note and accept as truthful the practitioner's evidence of her refusal of treatment of at least one anabolic abuser post 2010. 15. We do not find that any case cited to us by either party provides more than a general guide to a particular outcome. Rather, this case requires determination on its own unique facts. 16. It is relevant in the facts of this case we take into account the practitioner's long previously unblemished record, changes implemented in her practice post 2010, her present insight, her willingness to accept that a reprimand should be made, and to accept conditions on her registration. Absent these factors, we would have some lingering concerns about the practitioner's present fitness to practice. 17. The concern of the HCCC is that the practitioner is likely to fall into the same prescribing pattern as occurred in 2007-2009, and such conduct may present a risk to the public, and would result in a lowering of standards of the profession. We acknowledge that submission requires we afford it careful and weighty consideration. 18. We accept that the practitioner has found the disciplinary proceedings harrowing, and would not want to expose herself to any further disciplinary action. Albeit of recent origin, she has demonstrated a significant degree of insight, and has, since 2010, instituted changes in her record keeping, and aspects of her practice. 19. Having regard to the admissions made by the practitioner, her acceptance of the Tribunal's findings, and the changes made to her practice since the s 66 proceedings, we are not satisfied that she is presently unfit to practice. 20. However, we find the practitioner's primary submission that she should be permitted to practice without conditions is not sustainable given the evidence before us, much of which relies on statements of future intention by the practitioner, without any firm actions having been put into place to support her, and does not recognise and take into account the present significant degree of isolation of the practitioner from other professional contact. 21. During the course of the hearing we raised with the practitioner a number of proposed conditions including a condition that would require review and approval by an endocrinologist of her choice of the records of, and treatment plan for, any new male patient to whom the practitioner proposed prescribing and dispensing off label androgenic/anabolic drugs. Such a condition for a defined period would ensure the rigor of prescribing and treating patients the practitioner now espouses she will adopt. 22. Counsel for the HCCC, while maintaining in accordance with her instructions the position that the only appropriate order is cancellation of the practitioner's registration, indicated to the Tribunal that such a condition would be expensive, and may be difficult to monitor. However Ms Eastman kindly agreed to seek the Council's view about the proposed condition and its ability to monitor such a condition. The Tribunal records its gratitude to Ms Eastman, her instructor, Ms M Richmond of the HCCC, and the Council for assisting the Tribunal with comments on, and providing proposed draft conditions and doing so in a very timely manner. Ultimately, as discussed below, we have determined a slightly more flexible condition, but with the checks recommended by the Council should be implemented if the practitioner's registration is not to be cancelled. 23. The first concern is relevant and we have taken it into account. However, the practitioner's evidence is that this cohort of patients is likely to be small. We see the necessity for such a condition to be for a finite period. In these circumstances we find It is a cost which must be borne by the practitioner. It still affords her the opportunity to treat, when appropriate to do so male patients with low testosterone levels or other conditions likely, on appropriate peer review and approval, to benefit from supplementation. It is not as draconian as the protective orders imposed in the case of Dr Zacharia,(HCCC v Zacharia NSWMT 20 December 2011) and may be time limited to enable the practitioner to develop professional peer consultations while she expands her functional medicine practice. 24. We are of the view that the latter concern can be overcome by requiring a signed approval from an endocrinologist which can be faxed or emailed to the practitioner to be maintained in the particular patient's records, and the records subject of an audit twice within the ensuing two year period. This will provide objective evidence on which the Council can rely to monitor the condition. 25. The patient cohort included a number of patients in respect of whom the practitioner noted reported depression or depressive symptoms. The practitioner volunteered that she will, in future, implement as part of her practice use of a depression assessment tool. The Tribunal is aware of appropriate on-line courses to address the needs of such patients offered by The Black Dog Institute and Beyond Blue. We find the practitioner will be supported in her intention by a condition that she undertakes such course which may be completed as an on-line course. 26. During the Stage 1 hearing the practitioner gave evidence that her continuing professional development was substantially based on attending courses provided by her attendance at overseas conferences particularly in the US focused on ante-aging medicine. The practitioner does maintain her membership of the Royal Australian College of Physicians (the College) but she had not attended the College's conferences in recent years. The Tribunal was concerned about the somewhat narrow focus of the practitioner's continuing mandatory professional education. (CME) That concern will be overcome if the practitioner requests the College to conduct an audit of her CME on a bi-annual basis up to 2019 and the practitioner is required to provide a copy of the audit to the Council. 27. We note that the practitioner provided no character references. This fact corroborates our finding that she remains to a large degree professionally isolated. We are satisfied in these circumstances that the practitioner would benefit from a mentoring arrangement. 28. While we do not consider it necessary to impose a condition that the practitioner only practice in a group practice, we are concerned about the practitioner's apparent professional isolation. It is our recommendation that she should, as she enters into her proposed practice of integrative and/or functional medicine, ensure that she engages with fellow professionals in face to face peer review of cases. We also recommend that she follows through with her stated intention to participate in conferences conducted by the Royal Australian College of Physicians. Costs 1. In both her written submissions and orally at the conclusion of the Stage 2 proceedings Ms Eastman submitted that the Tribunal should make an order that the practitioner pay the HCCC's costs of and incidental to the proceedings. The practitioner's submissions did not contain any reference to costs, but at the conclusion of the Stage 2 hearing Mr Greenwood pointed out that we should take into account the late amendment by the HCCC of the complaint, and the fact that the HCCC did not establish a number of the particulars pleaded in respect of the complaint of unsatisfactory professional conduct. The relevant statutory provision and authorities on costs 1. The relevant principles to be applied in respect of costs applications in disciplinary proceedings are subject of considerable appellate authority (see Ohn v Walton (1995) 36 NSWLR 77). 2. Schedule 5D cl 13 (a NSW provision of the of the National Law) provides: The Tribunal may order the complainant (if any), the registered health practitioner or student concerned, or any other of person entitled to appeal (whether as of right or because leave to appear has been granted) at any inquiry or an appeal before the Tribunal to pay the costs to another person as decided by the Tribunal. 1. Clause 13 (2) and (3) provide a regime for obtaining a costs certificate from the Tribunal, and for the costs order to be enforced and judgment obtained in the District Court. 2. The question of the power to award costs is subject of discussion by Meagher JA, with whom Basten and Emmett JJA agreed, in Health Care Complaints Commission v Do. His Honour in the course of determining costs of the appeal, referred to the decision of the Court of Appeal in Health Care Complaints v Philipiah [2013] NSWCA 342 as follows: In Health Care Complaints Commission v Philipiah [2013] NSWCA 342 the Court accepted that "[a]s a general rule, costs of proceedings before the Tribunal should follow the event": at [42]. Noting that the mere impecuniosity of the losing party was not a justifiable reason for departing from that "rule", the Court also accepted "that there are factors that might militate against the recovery by the Commission of all of its costs in particular proceedings" including the possibility that the Commission was only partly successful, referring to Lucire v Health Care Complaints Commission (No 2) [2011] NSWCA 182 at [48]-[52]. Lucire dealt with a provision in the Medical Practice Act 1992 (NSW), Sch 2, cl 13, which also conferred an open power 1. His Honour went on to explain: Whatever the true extent of the power conferred on this Court in respect of costs of this appeal, it is appropriate to adopt the same approach as would have been adopted in the Tribunal, namely that there was an unfettered discretion, although the compensatory principle militated in favour of a successful party obtaining an order for costs. In Health Care Complaints Commission v Philipiah [2013] NSWCA 342 the Court accepted that "[a]s a general rule, costs of proceedings before the Tribunal should follow the event": at [42]. Noting that the mere impecuniosity of the losing party was not a justifiable reason for departing from that "rule", the Court also accepted "that there are factors that might militate against the recovery by the Commission of all of its costs in particular proceedings" including the possibility that the Commission was only partly successful, referring to Lucire v Health Care Complaints Commission (No 2) [2011] NSWCA 182 at [48]-[52]. Lucire dealt with a provision in the Medical Practice Act 1992 (NSW), Sch 2, cl 13, which also conferred an open power. Discussion and conclusion – costs. 1. We commence our discussion by noting that in these lengthy proceedings the HCCC established to the requisite civil standard the breaches of the National Law asserted in the complaint namely that the practitioner was guilty of unsatisfactory professional conduct and professional misconduct. 2. We accept the HCCC sought, and was granted leave, to amend the complaint towards the end of the hearing. However, that amendment did not require the experts to be recalled and did not involve any significant extension of the hearing time. 3. We also accept that the HCCC did not establish all particulars of the complaint. But the overwhelming majority of the particulars were established. We accept it was impossible for the HCCC, and the Tribunal, given the generalised nature of admissions made to curtail the hearing and accordingly reduce costs. Here the HCCC succeeded in breaches asserted of the National Law. Overall, we consider those patients in respect of whom the HCCC did not establish all particulars were the exception rather than the rule and do those instances do not justify a departure from the usual position. Accordingly we find the practitioner should pay the costs of and incidental to the proceedings of the HCCC. Orders 1. The Registrar, Occupational Division, NSW Civil and Administrative Tribunal is requested as soon as practicable to notify the Medical Council of NSW of the following orders and conditions. 2. The conditions imposed on Dr Julie Epstein's (the practitioner) registration on 10 July 2010 as varied on 10 December 2010 and further varied on 8 May 2012 are discharged. 3. The following order and practice conditions shall be recorded on the register of health practitioners maintained by the Australian Health Practitioner Regulation Agency (AHPRA) in respect of the practitioner: 1. The practitioner is reprimanded. 2. The practitioner shall not on and after 23 April 2015 for a period of two years prescribe or dispense to any new or existing male patient the following drugs: 1. Human growth hormone; 2. Testosterone; 3. Chorionic Gonadotropin (Pregnyl); 4. Anastrozole (Arimidex or its pharmacological equivalent); 5. Other anabolic/androgenic steroids (except DHEA) and/or 6. Nandrolone Deconate (Deca-Durabolin) UNLESS: 7. she first obtains written approval to prescribe as proposed from an Australian endocrinologist of her choice who is a currently practising Fellow of the Royal Australian College of Physicians who has reviewed the patient records and the practitioner's proposed treatment plan (that shall include proposed drugs to be prescribed); OR the patient is by reviewed the endocrinologist and the practitioner's treatment plan is approved by the endocrinologist. 8. The endocrinologist/s is referred to in (g) nominated by the practitioner is to be approved by the Medical Council of New South Wales (the Council). 1. To ensure compliance with Condition (2) the practitioner shall keep a copy of any approval by the endocrinologist of her prescribing and treatment plan for the patient in the relevant patient's records, and shall maintain a log listing all patients for whom the practitioner has prescribed or treated the patient with the drugs listed in Condition 2. The log is to include: 1. the full name and date of birth of the patient; 2. the name of the approved endocrinologist who approved the practitioner's proposed prescribing and treatment plan; 3. the medication plan (including the drug(s) prescribed); 4. whether the practitioner administered the drug(s); 5. a notation that the patient: 1. has received a copy of the Consumer Medicines Information (CMI) as required by the Therapeutic Goods Administration (TGA)or in the absence of a CMI, the product information (PI) sheet for all drugs included in the treatment plan, and 2. is aware and has understood whether the drug(s) are being used off-label (i.e. not for their TGA purposes) and that there may be as yet unknown side effects or adverse reactions for the drug(s) in the treatment plan. 1. The practitioner is to forward to the Council within three months of the date of the decision and each three months thereafter during the operation of condition 2: 1. (copies of any written approval from the endocrinologist/s referred to in Conditions (2) and (3) and 2. a copy of the log referred to in Condition (3). 1. The practitioner is to submit to two audits at her premises of a selection of her records for male patients seen after 23 April 2015 by a person nominated by the Council. The first audit is to occur within six months of the date of this decision and a second audit is to occur within 18 months of the date of this decision. 2. The auditor shall be requested to assess the practitioner's compliance with these conditions and the auditor should pay particular attention to the prescribing, supplying and administration of the drug(s) listed in condition (2) and the information provided by the practitioner in her logs, and the recording of physical examinations of the patients. 3. The practitioner is to authorise the auditor to provide the Council with a report on his/her/their findings 4. The practitioner is to meet all expenses associated with the approval process set out in conditions (2) and (3) and the audit. 5. IT IS NOTED THAT the purpose of the audit is to assess compliance with conditions (2) and (3). 6. The practitioner may if she deems it appropriate to do so request the Council to review conditions (2) to (8) on or after 23 April 2016 (the review date). Notwithstanding the review date the practitioner may request an earlier review and any earlier review shall be at the discretion of the Council. 7. Within 28 days of 23 April 2015 the practitioner shall submit to the Council the name and professional address of a registered medical practitioner, other than Dr Ross Walker or Dr Adrian Zentner who has agreed to act as her professional mentor for approval by the Council in accordance with the Council's compliance policy "Mentoring" (as varied from time to time). 8. Each meeting of the practitioner and her mentor is to include: 1. discussion of the practitioner's professional development and collaboration with professional colleagues; 2. medical practice issues highlighted in the Tribunal's reasons for decision published on 30 March 2015 and 23 April 2015 as well as any other medical or ethical practice issues as they arise. 1. The practitioner shall authorise the Council to provide any proposed and approved mentors with a copy of the Tribunal's reasons for decision dated 30 April 2015 and 22 April 2015 together with any other material deemed relevant by the Council. 2. The mentoring arrangement shall be for a period of twenty four (24) months and shall commence within one calendar month of approval of the mentor by the Council. 3. The practitioner shall authorise the mentor to provide any report which the Council may require to the Council. 4. In the event that the approved mentor is no longer willing or able to provide the mentoring required, the practitioner must within 21 days of the cessation of the original mentoring arrangement provide in writing to the Council details of a replacement mentor (the substitute mentor) to be approved by the Council. The requirements for the practitioner's mentoring for the substitute mentor and the practitioner shall be identical to those prescribed in conditions 11 to 15 of these conditions. 5. The practitioner shall request the Royal Australian College of Physicians (the College) to include in its annual audit process a bi-annual audit of the practitioner's continuing mandatory professional development obligations during the period from April 2015 to April 2019 and the practitioner shall authorise and request the College to provide a copy of any audit report to the Council. 6. The practitioner shall within 6 months of 23 April 2015 enrol in and complete a course in depression assessment tools available on-line by Black Dog Institute or Beyond Blue and provide evidence in writing to the Council of her successful completion of the course. 7. In the event that an on-line course is not offered by Black Dog or Beyond Blue in the relevant period then the practitioner shall enrol in and complete such other course in depression assessment tools or like course as may be nominated by the Council. 8. The practitioner shall authorise and consent to any exchange of information between the Medical Council of NSW and Medicare Australia and Pharmaceutical Services for the purpose of monitoring compliance with these conditions. 4. The practitioner shall pay the Health Care Complaints Commission's costs of and incidental to the proceedings as agreed. Failing agreement application may be made to the Tribunal. 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: 23 April 2015