Health Care Complaints Commission v Malouf

Solicitors: Health Care Complaints Commission (Applicant) Avant Law Pty Ltd (Respondent) File Number(s): 2018/00312313 Publication restriction: Under Cl 7 of Schedule 5D of the Health Practitioner Regulation National Law (NSW) an order is made prohibiting disclosure to any person or entity of the names of the patients set out in the schedule to the complaint.

Overview of complaint

1. Dr Malouf is a general practitioner practising in Parramatta. The Health Care Complaints Commission (HCCC) complains that he is guilty of "unsatisfactory professional conduct" and "professional misconduct" because of the circumstances in which he prescribed drugs of addiction including alprazolam to nineteen patients and diazepam to one patient. Alprazolam (dispensed under trade names including Xanax and Kalma), and diazepam (dispensed under trade names including Valium) are types of benzodiazepines. Benzodiazepines are prescribed mainly for problems relating to anxiety and sleep. Alprazolam is most commonly used in the short-term management of anxiety disorders, specifically panic disorder or generalised anxiety disorder.
2. Since 2014, alprazolam has been classified as a "drug of addiction" under Schedule 8 to the Poisons and Therapeutic Goods Act 1966 (NSW). Diazepam is classified as a "restricted substance" under Schedule 4 to the Poisons and Therapeutic Goods Act. Practitioners need an authority from the Ministry of Health before prescribing alprazolam to a "drug dependent person". Even if a person is not drug dependent, a practitioner needs an authority before continuing to prescribe alprazolam for more than two months: Poisons and Therapeutic Goods Act, ss 28 and 29. Dr Malouf did not apply for an authority for any of the nineteen patients identified in the complaints.
3. Dr Malouf had prescribed other benzodiazepines to his patients but only began prescribing alprazolam in 2013. Around that time, Parramatta Mission and Fleetstreet Clinic (Western Sydney Drug Health Fleet Street Opioid Treatment Medical Services) referred some patients to him. After that, other patients came by word of mouth from existing patients. Most of the 19 patients were long-term users of benzodiazepines.
4. Each patient is from a socially disadvantaged background and has complex mental health and, in some cases, physical problems. Many have been victims of physical or sexual assaults; others had dysfunctional relationships with family and partners. Several had spent time in gaol and a few had had their children removed from their care. Every patient was on an Opioid Treatment Program (OTP) and at least 14 were "drug dependent".
5. Dr Malouf diagnosed each patient with anxiety and some with depression, panic attacks and agoraphobia, or a combination of those conditions. He prescribed alprazolam for every patient, except Patient I who he prescribed diazepam (Valium). He prescribed Patient C with diazepam and alprazolam sequentially. He prescribed Patient E with alprazolam and paracetamol and codeine (trade name Panadeine Forte). As well as alprazolam, Dr Malouf prescribed fluoxetine (trade name Prozac) for Patient T and fentanyl (an opioid) to Patient S.
6. In every case, Dr Malouf judged the patients as being "credible, straight and engaged", and in genuine need of help. He said his aim was to control and stabilise these patients' conditions through regular support, counselling, encouragement and guidance. He told them that his ultimate aim was to take them off the medication with their agreement. However, over a period of more than two years, only one patient agreed to withdraw from alprazolam.
7. In summary, the central allegations of the complaints are that for various patients, Dr Malouf prescribed alprazolam and/or diazepam: 1. without conducting an appropriate assessment; 2. without appropriate or timely referrals to another specialist or allied health provider, including a psychologist or psychiatrist; 3. for a purpose other than an appropriate therapeutic purpose; 4. in excessive quantities; 5. where the patient was enrolled in the NSW Opioid Treatment Program; 6. where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug; 7. when he did not have authority to prescribe alprazolam; 8. when he knew or ought to have known that the patient had a drug dependency.
8. The complaint in full is attached as Appendix A. Each of the 20 complaints relates to an individual patient. Each complaint contains several "particulars" which allege specific conduct in relation to that patient. There are 159 particulars.
9. The HCCC seeks cancellation of Dr Malouf's registration together with an order that he not be entitled to apply for re-registration for two years. In addition, the HCCC submits that Dr Malouf should be reprimanded and pay their costs of these proceedings.
10. On 30 March 2016, following a visit from the Pharmaceutical Regulatory Unit (PRU), Dr Malouf agreed to relinquish his authorities to possess, supply, administer or prescribe "drugs of addiction" and some other drugs. There is currently a condition on his registration to that effect. Dr Malouf submits that even if we find professional misconduct, he should be permitted to continue to practise with the current conditions in relation to prescribing rights.

Issues

1. Broadly stated, the issues are whether the 159 particulars set out in complaints 1 - 20 constitute unsatisfactory professional conduct and whether the particulars set out in complaint 21 constitute professional misconduct. After making findings as to those questions, we must decide what, if any, protective orders are appropriate and whether Dr Malouf should be ordered to pay the HCCC's costs.
2. We begin by outlining the definitions of unsatisfactory professional conduct and professional misconduct and the relevant legal requirements and guidelines. We then summarise Dr Malouf's response to the complaints and the expert witnesses' opinions.
3. Rather than making findings on each of the 159 particulars in numerical order, we have grouped the particulars by subject. We begin by making findings about the fact that Dr Malouf did not have the required authorities. We then move to consider other aspects of the complaints such as whether Dr Malouf conducted an appropriate assessment, whether he made appropriate or timely referrals and whether the quantities he prescribed were appropriate. In each case, we summarise the allegations, set out the legal or other principles relating to those allegations, present Dr Malouf's response and the experts' opinions and then express our view as to whether the conduct is below the standard.

Unsatisfactory professional conduct and professional misconduct

1. The HCCC complains that the conduct outlined in the complaints amounts, at least, to "unsatisfactory professional conduct". That term is defined in s 139B(1)(a) of the Health Practitioner Regulation National Law (NSW) (National Law) to include: Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
2. In these reasons, when we refer to the "standard", we are referring to the standard "reasonably expected of a practitioner of an equivalent level of training or experience" as described in s 139B(1)(a). Dr Malouf has more than 40 years of general practice experience.
3. Complaint 21 is that with the exception of six particulars, each particular is relied on individually as constituting professional misconduct and complaints 1 - 20 are relied on "cumulatively or in any combination". The six exceptions are Complaint Three, particulars 1(e), (f) (relating to the quantities of alprazolam and diazepam prescribed to Patient C); Complaint Six, particular 1(b) (relating to the assessment of Patient F before prescribing diazepam); Complaint 13, particular 1(f) (prescribing alprazolam when Dr Malouf knew or ought to have known that Patient M may have had a drug dependency) and Complaint 15, particulars 1(b) and (c) (prescribing alprazolam to Patient O without making appropriate or timely referrals for assessment and advice and in circumstances where it was not prescribed for a therapeutic purpose).
4. Professional misconduct is defined in s 139E of the National Law in the following terms: (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
5. The significance of alleging that Dr Malouf is guilty of professional misconduct is that, if proved, the Tribunal has power to suspend or cancel Dr Malouf's registration, although we are not obliged to do so: National Law, s 149C(1)(b).

Legal requirements and guidelines

1. The published risks of overdose and overdose deaths, in conjunction with other centrally acting drugs, notably opioids, led to the re-scheduling of alprazolam. In addition to the statutory provisions relating to obtaining an authority before prescribing alprazolam, guidelines have been produced to assist practitioners when prescribing benzodiazepines. In 2015, the Royal Australian College of General Practitioners produced a publication entitled "Prescribing drugs of dependence in general practice". Part B of the guideline relates to benzodiazepines. The guidelines are designed to assist practitioners in prescribing benzodiazepines in circumstances where data suggests that they may be overprescribed or prescribed outside published guidelines. We will refer to these guidelines as the "dependence guidelines".
2. The dependence guidelines outline eight key principles. We have reproduced principles 1-5 and 7 because they are the most relevant to the complaints. They relate to issues including the assessment of patients, the risks and benefits of prescribing benzodiazepines and the length of time benzodiazepines should be prescribed. 1. Prescription of benzodiazepines, as with any treatment, should be based on a comprehensive medical assessment; a diagnosis; thoughtful consideration of the likely risks and benefits of any medication, as well as alternative interventions; and a management plan derived through shared decision making and continual clinical monitoring. 2. GPs should be aware of the common concerns associated with benzodiazepines, such as potential dependence, withdrawal, problematic drug use (including diversion and misuse) and known harmful effects, including falls, potential cognitive decline and motor vehicle accidents. These risks should be discussed with patients. 3. Treatment seeks to maximise outcomes for the health and social functioning of the patient while minimising risks. To minimise risks, benzodiazepines should be prescribed at the lowest effective dose for the shortest clinical timeframe. 4. Avoid prescribing benzodiazepines to patients with comorbid alcohol or substance use disorders or polydrug use. GPs should consider seeking specialist opinion in the management of these patients. Patients who use two or more psychoactive drugs in combination (polydrug use) and those with a history of substance misuse may be more vulnerable to major harms. 5. Benzodiazepines are generally regarded by clinical practice guidelines as a short-term therapeutic option. Long-term use, beyond 4 weeks, should be uncommon, made with caution and based on thoughtful consideration of the likely risks and benefits of benzodiazepines. - If alternatives to benzodiazepine treatment fail, have limited benefit or are inappropriate (either psychologically or pharmacologically), supervised benzodiazepine treatment may remain an acceptable long-term therapeutic option. - Long-term benzodiazepine prescriptions should be at the lowest effective dose, preferably given intermittently, and regular attempts at reduction should be scheduled. Continued professional monitoring of health outcomes is required. - Benzodiazepines should be prescribed from one practice and preferably one GP and dispensed from one pharmacy. . . . 7. GPs should develop strategies to manage inappropriate requests for benzodiazepines by patients.
3. There are greater risks for patients who have previously misused drugs such as opioids. At 1.6.3.3, under the heading "Assessing risk," the dependence guidelines state that: Patients who previously misused drugs (e.g. opioids, anti-alcohol or smoke cessation treatments) have a higher risk of becoming excessive users compared to patients who have not previously misused drugs. Greater challenges exist for patients already prescribed benzodiazepines for some time. Once a benzodiazepine prescription has been started, it may be harder to stop. To minimise harms associated with prescription drug misuse, GPs need to maintain vigilance in identifying SUDs (substance use disorders), assist patients in recognising disordered use where it exists, set goals for recovery and assist patients to seek appropriate treatment. (Words in brackets added.)
4. The Drug and Alcohol Withdrawal Clinical Practice Guidelines - NSW produced by NSW Health and published on 4 July 2008, set out assessment issues specific to benzodiazepine-dependent patients at 4.2. We will call these guidelines the "withdrawal guidelines". Practitioners should determine whether a patient is dependent on therapeutic doses of benzodiazepine medication or are intermittent or regular high-dose benzodiazepine users, usually in the context of dependence on multiple drugs. Under the heading "Problems with multiple drug use and multiple prescribers", these guidelines warn that, "Prescribing benzodiazepines to polydrug users poses serious risks." The withdrawal guidelines go on, at p 29, to state that: In seeking to manage these patients, there is an invidious trade-off between the risks of trying to stabilise the patient by prescribing benzodiazepines (thereby placing patients at risk of overdose, prolonging the problem, and adding to the pool of black market drugs), or not intervening and placing the patient at risk of major withdrawal. There are no easy answers to the problem; clinical judgement must prevail. Clinical reasoning should be documented clearly.
5. If a doctor does prescribe long-term benzodiazepines for polydrug users, the withdrawal guidelines suggest at p 30 that another practitioner, preferably a specialist, review those patients periodically for a second opinion. Long-term therapy may be justified for a small number of patients, but that decision needs to be documented and may also involve a second opinion by a specialist. (See withdrawal guidelines at 5.6.)
6. Consistently with both the dependence guidelines and the withdrawal guidelines, the application form for an authority to prescribe alprazolam asks various questions. Those questions include whether the practitioner considers the patient to be drug dependent, whether the patient is using drugs illegally, is "doctor shopping" or has been using drugs for longer periods than appropriate. Practitioners are also required to indicate whether the patient is on an Opioid Treatment Program (OTP), including a methadone program. If that is the case, a letter from the authorised OTP prescriber supporting benzodiazepine treatment must be attached. A second opinion from a psychiatrist or Addiction Medicine specialist may be required. Prior to initiation or re-initiation of alprazolam, the form notes that it is expected that the patient will have been reviewed by a psychiatrist. The practitioner is also required to indicate the proposed maximum daily dose of alprazolam.

Summary of Dr Malouf's response to the complaints

1. Dr Malouf accepts the factual basis for the complaints, including that he prescribed medications as set out in the agreed table. He does not formally admit that any of the particulars constitute unsatisfactory professional conduct or professional misconduct. His response to the complaints was to accept the following "imperfections" and "failings" in his practice and, at times, in his thinking.
2. He should have known that he needed an authority to prescribe alprazolam. Other than reading the product information, he did nothing to educate himself about the risks posed by alprazolam. He did not look at any guidelines on the subject such as the Therapeutic Guidelines or the dependence guidelines. He should have educated himself on the relative strength of alprazolam compared to diazepam. He thought alprazolam was less sedating and that it helped with severe anxiety and panic attacks. He also concedes that despite alprazolam being indicated for short-term use (less than 2 months) in most cases, he thought of it as being for medium term (6 - 12 months) or longer-term use.
3. Dr Malouf also acknowledged that he should have been more diligent in obtaining patients' medical histories. He should have pressed patients to tell him if they were on an OTP program such as a methadone program, and he should have been more proactive in contacting other prescribers. He maintained that the issue of diversion of alprazolam only came up for one or two patients.
4. Although acknowledging these failings, Dr Malouf highlighted various practices which he said mitigated the risks associated with prescribing alprazolam. For example, he never bulk-billed. Instead he charged a $10 upfront fee as "a means to weed out those simply seeking a free 'try-on'". He almost invariably gave only a weeks' supply, although some patients were given up to 4 weeks' supply. He made some efforts to exercise vigilance including calling the Doctor Shopping Hotline, although he did not ask questions or adjust his prescribing for patients known to that hotline. He did not routinely give repeat prescriptions although he gave three repeats to Patient D, two to Patient S and one each to Patients E and Q. He did not routinely give private scripts but he once gave a private script to Patient B. In another case, he required a patient to pick up the medication from the pharmacy each day.
5. Typically, Dr Malouf also prescribed an anti-depressant "with calming benefits with the intention of possibly reducing and weaning Kalma in due course". He says he always intended to try to wean a patient off the medication as soon as possible. He reduced the quantity of tablets for some patients and succeeded in weaning one patient off alprazolam completely.
6. Dr Malouf stated that he was striving to be a "life coach" for these patients and they often commented on his willingness to listen and to help. In an interview with the PRU on 30 March 2016, he said, "I have a reputation for being a prescriber of Kalma (alprazolam), yes, but also a doctor who listens." At the hearing, Dr Malouf clarified that he thought at the time, that alprazolam was an ideal medication and that his reputation was based on his good management of patients, not the medication he was prescribing. His preference is for low volume, high quality work with a strong emphasis on continuity of care for more complex patients. For each of the 20 patients, Dr Malouf stated that "every reasonable opportunity was taken to discuss their readiness to wean their benzo usage".

Qualifications

1. The HCCC's expert was Dr Gary Deed. He has worked exclusively as a general practitioner in a multi-doctor inner Brisbane practice. He graduated from the University of Queensland in 1985 with a first class honours degree in Medicine. He has published articles with other authors on issues including managing depression and anxiety with St John's wort and Kava.
2. Dr Malouf's expert witness was Emeritus Professor Ian Webster AO. E/Prof Webster is an emeritus professor of Community Medicine and Public Health at the University of New South Wales. From 1976 - 1991 he was the foundation Professor and Head of School of Community Medicine, Faculty of Medicine, University of New South Wales. From 2004 - 2017 he was a consultant physician at the Shoalhaven Drug and Alcohol Service and Visiting Medical Officer at the Shoalhaven District Memorial Hospital. He is a highly qualified addiction specialist who has occasionally performed the role of a general practitioner, especially with homeless people, on an irregular and voluntary basis.
3. The experts gave evidence together so that they could be asked the same questions and comment on each other's answers. They agreed that each of the 20 patients had "multi-morbidities" and that there were substantial risks in prescribing alprazolam to those patients. Dr Deed's overall assessment was that Dr Malouf did not appreciate his limitations in managing this complex set of patients and did not keep up to date with the need for an authority to prescribe alprazolam. The clinical issues and social problems that these patients had were beyond his knowledge and capacity.
4. E/Prof Webster emphasised the practical difficulties in managing the problems of drug-addicted patients. He said these difficulties were beyond the capacity and skills of a general practitioner practising alone. He emphasised that there are few practising addiction medicine specialists and the load of care generally falls to general practitioners. E/Prof Webster's view was that Dr Malouf was attempting to be empathetic and to build good relationships with his patients. He regarded Dr Malouf as trying to minimise the risk of harm to the patient and to others but as lacking awareness of the full range of potential harms and risks.

Opinion about guidelines

1. Both experts agreed with principles 1-4 in the dependence guidelines. As to principle 5, which recommends first trying alternatives to benzodiazepine treatment, both experts agreed with the guidelines that the first-line therapy for generalised anxiety disorder, panic disorder and panic attacks should be cognitive behaviour therapy (CBT). E/Prof Webster emphasised the practical problems saying that CBT is "hard to organise" and that general practitioners can give general counselling. E/Prof Webster said that SSRI's (selective serotonin reuptake inhibitors) are the most commonly prescribed anti-depressants and are an alternative to benzodiazepines for managing anxiety and social phobia.
2. The expert witnesses were questioned about the term "polar opinions" in the foreword to the dependence guidelines: Benzodiazepines have a chequered clinical history and continue to produce polar opinions in the medical community. Benzodiazepines have been associated with both benefits and harms for patients, and a clear guide for accountable prescribing has been requested from multiple agencies.
3. E/Prof Webster responded by saying that benzodiazepine consumption raised safety concerns. While benzodiazepines can induce unconsciousness and coma when combined with other centrally acting agents, that is a rare situation. Side effects include the risk of suicide but clinical trials often do not include the treatment seeking population group.
4. We have quoted the withdrawal guidelines which highlight the "invidious trade-off between the risks of trying to stabilise the patient by prescribing benzodiazepines. . . or not intervening and placing the patient at risk of major withdrawal". In general, Dr Deed's evidence reflects the view that the risks of prescribing benzodiazepines, including the risk of overdose, prolonging the problem and adding to the pool of black market drugs, are more significant than the risk of not prescribing alprazolam. In relation to discontinuing benzodiazepine use, both experts agreed with the guidelines that "[I]f benzodiazepine use disorder has become moderate or severe, it can become a long-term and distressing problem."
5. In relation to long-term benzodiazepine use for polydrug users, E/Prof Webster emphasised that it is difficult to withdraw people with drug dependence from benzodiazepines. In his view, it is reasonable to continue prescribing benzodiazepines at a low stable level for patients with a mental health diagnosis who are on a stable high dose of benzodiazepines. (See dependence guidelines at p 29). However, later in his oral evidence he conceded that he does not prescribe long-term alprazolam routinely and has only done so on one or two occasions.

Opinions as to seriousness of the conduct

1. As shorthand, the experts have indicated in their evidence that when conduct falls significantly below "the standard", it amounts to unsatisfactory professional conduct. When the conduct also attracts their "strong criticism", they are of the view that it constitutes professional misconduct.
2. Dr Deed assessed the majority of the particulars in the 20 complaints as constituting professional misconduct. The particulars which he regarded as constituting only unsatisfactory professional conduct were Complaint 15, particulars 1(b) and (c) and Complaint Nine, particular 1(c).
3. In E/Prof Webster's opinion, only one of the particulars was significantly below the standard, and therefore meeting the definition of unsatisfactory professional conduct. That particular is Complaint Nine, particular 1(b) - that Dr Malouf prescribed Diazepam to Patient I without making appropriate or timely referrals for assessment and advice. The only conduct that he regarded as significantly below the standard and attracting his strong criticism, and therefore meeting the definition of professional misconduct, was Complaint 12, particular 1(b) - that Dr Malouf prescribed alprazolam to Patient L without making appropriate or timely referrals for assessment and advice.

Overall assessment of experts' opinion

1. The experts had very different opinions as to the seriousness of Dr Malouf's conduct. Dr Deed considered almost all of the 159 particulars to constitute professional misconduct while E/Prof Webster considered only one particular to be in that category. It was put to Dr Deed that he had limited experience with this cohort of patients and that, impliedly, his evidence was not as well informed as a person with more experience. Dr Deed responded by agreeing that only a very small percentage of his patients are addicted to drugs, homeless, have experienced sexual abuse or have been incarcerated. However, he said he had worked in a low socioeconomic area from 1989 - 1995, when he first graduated. There was a high incidence of drug use and drug dependence in that area.
2. The fact that Dr Deed has not had extensive experience with patients like the 20 patients the subject of the complaints, does not persuade us to prefer E/Prof Webster's assessment of the seriousness of Dr Malouf's conduct. Dr Deed's assessment accords with the tenor of the legal requirements and the guidelines. It is also largely consistent with the views of the professional members of the panel.
3. We do not accept, as a criticism of Dr Deed's evidence, that he made a blanket and unjustifiable judgement that every single particular constituted unsatisfactory professional conduct or professional misconduct. His stance can be explained by the fact that, ultimately, the HCCC only relied on particulars of complaints where Dr Deed had expressed the view that the conduct was significantly below the standard. For example, in the Amended Complaint relied upon in the Tribunal proceedings, the HCCC did not include several particulars relating to record keeping because Dr Deed had not been critical of Dr Malouf's conduct.
4. On the other hand, in our view, E/Prof Webster's views were overly generous to Dr Malouf. We appreciate that E/Prof Webster understands many of the practical difficulties of engaging with patients who are drug dependent, but we do not accept that Dr Malouf's conduct can be excused or minimised because of those difficulties. In addition, E/Prof Webster's own practice is not to prescribe alprazolam to these kinds of patients. He told the Tribunal that he has only prescribed alprazolam on one or two occasions.
5. We are also of the view that, in some cases, E/Prof Webster failed to make appropriate concessions. As an example, he was not particularly critical of Dr Malouf's failure to refer Patient Q for other treatment following his hospitalisation after a deliberate overdose. He said only that Dr Malouf could have referred Patient Q to a psychiatrist, not that he should have done so.
6. E/Prof Webster was not critical of Dr Malouf's ignorance as to the need for an authority to prescribe alprazolam. Even though he did not intentionally flout the legislative requirements, Dr Malouf's ignorance is, in our view, deserving of strong criticism in circumstances where he was treating 20 patients with drug dependence issues.
7. Overall, we consider that Dr Deed's opinions are consistent with current standards of practice for prescribing drugs of addiction and treating patients on methadone programs or who are drug dependent.

No authority to prescribe and knowledge of drug dependence

Summary of allegations

1. It is alleged for each patient, except Patient I, that Dr Malouf did not have authority to prescribe alprazolam under s 29 of the Poisons and Therapeutic Goods Act, contrary to the requirements of s 28 of that Act. In addition, for Patient E, that he did not have authority to prescribe codeine, that for Patient H, he did not have authority to prescribe oxycodone and that for Patient S, he did not have authority to prescribe fentanyl.
2. A representative from the PRU interviewed Dr Malouf on 30 March 2016. Dr Malouf confirmed that he had continued to prescribe alprazolam without applying for an authority after being told that an authority was required. He spoke on the phone to a PRU representative on 1 February 2016 and received a confirmatory letter from the PRU on 3 February 2016. Dr Malouf admitted that he knew he was required to have an authority from 1 February 2016. Despite that, he continued to prescribe a weeks' supply to his patients until the end of March 2016.
3. Directly related to these allegations are the separate allegations that Dr Malouf prescribed alprazolam "in circumstances where he knew or ought to have been aware that the patient may have had a drug dependency". (Emphasis added.) The particulars assert that Dr Malouf prescribed alprazolam in circumstances where he knew or ought to have been aware that 14 patients (Patients E, G, H, J, K, L, M, N, O, P, Q, R, S and T) may have had a drug dependency.
4. We have dealt with these two sets of allegations together because, although framed slightly differently, they are related. Dr Malouf required an authority from the Ministry of Health before prescribing certain medication. For 14 patients, that was the case both because he should have formed the opinion that the patient was a "drug dependent person" and because he prescribed the medication for more than two months. For the remaining patients, the authority was required because of the length of time he had been prescribing alprazolam.

Legal requirements or guidelines

1. On 1 February 2014, alprazolam was re-classified as a "drug of addiction" under the Poisons and Therapeutic Goods Act. Under s 28(2) of that legislation: (2) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe or supply a type B drug of addiction: (a) for continuous therapeutic use by a person for a period exceeding 2 months, Alprazolam is a type B drug of addiction: Poisons and Therapeutic Goods Regulation 2008, Reg 123 (a1). Consequently, a medical practitioner must not prescribe alprazolam for continuous therapeutic use for a period exceeding 2 months without obtaining the proper authority.
2. Under s 28(3) of the Poisons and Therapeutic Goods Act: (3) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe for or supply to a person who, in the opinion of the medical practitioner or nurse practitioner, is a drug dependent person a type C drug of addiction.
3. Alprazolam is a type C drug of addiction because it is a drug of addiction, other than a type A drug of addiction: Poisons and Therapeutic Goods Act, s 28(6).
4. A "drug dependent person" is defined in s 27 to mean "a person who has acquired, as a result of repeated administration of (a) a drug of addiction, or (b) a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985, an overpowering desire for the continued administration of such a drug." Consequently, a medical practitioner must not prescribe alprazolam to a person who, in his or her opinion, comes within the definition of a drug dependent person without obtaining the proper authority.
5. Principle 4 of the dependence guidelines counsels practitioners to ". . . avoid prescribing benzodiazepines to patients with comorbid alcohol or substance use disorders or polydrug use." Principle 5 emphasises that: "Benzodiazepines are generally regarded . . . as a short-term therapeutic option. Long-term use, beyond 4 weeks, should be uncommon, made with caution and based on thoughtful consideration of the likely risks and benefits of benzodiazepines."
6. Codeine, oxycodone and fentanyl are also Schedule 8 drugs which require an authority before prescribing to a drug dependent person.

Dr Malouf's response

1. Dr Malouf says he did not remember receiving the notification from the PRU in December 2013 informing doctors of the need for an authority. If he did receive it, he did not absorb the contents. He said that could be explained by the fact that in late 2013, his sister was terminally ill and was in and out of intensive care before passing away on 7 January 2014. That was a period of immense emotional distress and mental distraction for him. He apologised for his "inadvertent failure".
2. He appreciates that he should have educated himself about the need for an authority but did not admit that his conduct in prescribing without an authority amounts to unsatisfactory professional conduct.
3. In relation to prescribing fentanyl to Patient S without an authority, Dr Malouf said that he was aware that fentanyl was a Schedule 8 drug but did not think he needed an authority unless he was prescribing it for more than two months. As far as we are aware, he did not respond to the allegation of prescribing codeine or oxycodone without an authority, but we assume that his response would have been the same as for prescribing fentanyl.
4. In response to the criticism that he continued to prescribe alprazolam even after a phone call on 1 February 2016 and receiving the letter from the PRU on 3 February 2016, Dr Malouf maintains that it was never his intention to flout the rules or the NSW Health directives. In his mind, he "moved expeditiously to attempt to satisfy all requirements at a realistic and safe pace with only the welfare of (his) patients at heart."
5. The PRU representative suggested that Dr Malouf may wish to contact the Drug and Alcohol Specialist Advisory Service (DASAS), a 24-hour telephone service. In the telephone conversation, Dr Malouf was informed that interim authorities may be granted while patients were scheduled to be reviewed by a relevant specialist. The letter concluded with an invitation to contact a PRU representative if he required any clarification.
6. Dr Malouf explained that the delay in applying for authorities was due, in part, to the Easter holidays. He did not apply for an interim authority because he thought that would be unable meet the criteria for his patients. He emphasised that he took some action including arranging for his patients to be seen by a psychiatrist. He thought the process would take two to three weeks. He characterises his actions as a "technical breach" but thought at the time that the PRU would consider the circumstances. In retrospect, he says he should have come to some agreement with the PRU about what he should do.
7. He says he continued to prescribe because of the risk to the patients of suddenly withdrawing the medication. In his mind, he was placed in the impossible position of choosing between the welfare of his patients and the need to satisfy the statutory requirement of obtaining an authority. He decided to obtain psychiatric input before applying for an authority for each of his nineteen patients. He made some efforts to do so over the following month, however representatives from the Pharmaceutical Division of NSW Health attended on 31 March 2016. He was told that he could not continue to write scripts for alprazolam without an authority.
8. In response to the particulars that Dr Malouf "knew or ought to have been aware that a patient may have had a drug dependency", Dr Malouf acknowledged that he failed to recognise drug seeking behaviour in some patients or fully recognise it in others. He made the following specific comments in relation to eight of the fourteen patients where it is alleged that he knew or ought to have been aware that they may have had a drug dependency.
9. Patient E admitted occasionally buying heroin off the street, as well as a small number of benzodiazepines and said, "Xanax (was) the best." He suffered chronic back pain and other serious health issues. For Patient E, Dr Malouf said that he felt, at the time, that taking into account patient sincerity, genuine need, safety and stability combined with tight monitoring and control, prescribing alprazolam in these circumstances was a "necessary compromise".
10. Dr Malouf acknowledged some failings for Patient G who told him that she was dependent on alprazolam and wanted to get off them. According to Dr Malouf, he had "almost weaned this patient off alprazolam by the time of the PRU visit on 30 March 2016."
11. On 16 June 2016, Dr Malouf's notes record that Patient K was hospitalised after having a seizure. On the same day, Patient K told doctors that he was using Xanax, Valium, ICE and intermittently injecting methadone. Dr Malouf did not discuss these matters with the Emergency Department or complete a mental health plan for this patient.
12. Dr Malouf acknowledged failings for Patient N. He was aware that this patient occasionally misused drugs. He saw that as being consistent with the "medical need for symptom control". He accepts now that his approach was "less than ideal". E/Prof Webster noted that this patient "was known . . . . as a person with serious problems and addiction, and its sequelae, including regular use of alprazolam."
13. For Patient O, Dr Malouf again saw prescribing alprazolam as being consistent with the "medical need for symptom control".
14. For Patient P, Dr Malouf acknowledged some failings. He was aware of some drug abuse, "but more in the line of a desire for help". A police officer rang Dr Malouf on 24 February 2015 and told him that Patient P was found with an OxyContin tablet (oxycodone). Dr Malouf says he discussed the police phone call with Patient P at length and felt they understood one another. Dr Malouf now says, "he should have tightened his supply of alprazolam for a trial period of time."
15. Dr Malouf was aware of some limited drug misuse in relation to Patient S from a call to the Doctor Shopper Hotline, where he was known. Again, he interpreted this as "more in line with his medical needs for symptom control". He "even proceeded to a staged dispensation of his medications by the local pharmacist". Dr Malouf acknowledges that when prescribing fentanyl for Patient S, the initial dose was "higher than ideal" and that it was "less than ideal" to prescribe that drug when he knew or should have known that Patient S may have been drug dependent.
16. For Patient T, Dr Malouf was aware of "some limited drug abuse but more in the line of a desire for medical relief of her symptoms." He accepted the reality of Patient T's current benzo usage and desire for help. She needed control and stabilisation of her condition and removal from the street with all its inherent risks. He initiated Kalma 2mg per day and gave a weeks' supply (14 tablets).
17. In response to the fact that he prescribed alprazolam for much longer than 2 months, Dr Malouf said that he has always known that medium to long-term benzodiazepines use is "less than ideal". However, for this cohort of patients, he felt that "the imperatives of safety, stability and space to grow justifiably overrode this ideal." He said that from now on, he would be far more cautious when prescribing benzodiazepines beyond the short term.

Experts' opinion

1. The experts agreed that Dr Malouf should not have prescribed alprazolam outside the regulatory framework. They fundamentally disagreed about the seriousness of doing so.
2. Neither expert was asked expressly whether the failure to obtain an authority after two months of prescribing constitutes unsatisfactory professional conduct. The question the HCCC asked the experts about this conduct was: "Did this patient exhibit any drug seeking behaviours? If so, did Dr Malouf respond appropriately to this behaviour?" The HCCC also asked the experts: "Was it appropriate for Dr Malouf to prescribe Schedule 8 drugs to this patient without an authority under s 28 of the PTG Act?"
3. Dr Deed expressed the view that failing to obtain an authority to prescribe alprazolam is professional misconduct despite the fact that he was not aware that he needed an authority. Dr Deed regarded that conduct as falling significantly below the standard in every case and invited his strong criticism.
4. E/Prof Webster's view was that Dr Malouf's conduct fell below the standard but not to a significant degree and did not merit his strong criticism. E/Prof Webster was profoundly influenced in his assessment of Dr Malouf's conduct by the fact that he did not know that he needed an authority to prescribe alprazolam. While it is incumbent on doctors to keep up to date, he said the formal communications from the Ministry of Health is generally inadequate. Nevertheless E/Prof Webster thought that Dr Malouf probably did know that alprazolam needed careful clinical oversight and control.
5. In E/Prof Webster's view, long-term use of benzodiazepines is common, although that does not necessarily apply to alprazolam. He conceded that "for legal reasons" there is an issue if alprazolam is prescribed for more than two months, but added that for some people, it is reasonable practice to prescribe alprazolam for longer. When asked if he would prescribe alprazolam for a continuous period of up to two years, E/Prof Webster replied that he would not personally do so because he is a consultant and not the GP managing the patient. He would not condone the prescription of any benzodiazepine unless the patient is very tightly controlled.

Conclusion

1. Dr Malouf did not have an authority to prescribe alprazolam (for 19 patients), codeine (for Patient E), oxycodone (for Patient H) or fentanyl (for Patient S). He needed an authority because he prescribed these medications for a period exceeding 2 months and/or he knew or ought to have been aware that 14 patients may have had a drug dependency. The so-called "imperatives of safety, stability and space to grow" did not justify prescribing these medications for more than 2 months without an authority. E/Prof Webster's view was that it is reasonable practice in some circumstances to prescribe benzodiazepines, including alprazolam, for longer than two months. While that is the case, we agree with the dependency guidelines that use beyond four weeks "should be uncommon, made with caution and based on thoughtful consideration of the likely risks and benefits. . ." Dr Malouf routinely prescribed for more than four weeks and did so with almost no understanding of the full range of risks and benefits.
2. Dr Malouf appears to acknowledge that he knew, or should have known, that patients E, G, K, N, O, P, S and T were (or may have been) drug dependent persons. We find, on the basis of the clinical notes, that Dr Malouf should have known that the remaining six patients (H, J, L, M, Q and R) were also drug dependent persons.
3. We find that Dr Malouf did not know that he needed an authority to prescribe these medications. He was ignorant of the legislative requirements until he was told about them on 1 February 2016. His ignorance can be attributed, in part, to the stressful circumstances he was under when the requirement became law. We do not agree with E/Prof Webster's view that it was a result of any deficiencies in the way the Ministry of Health communicates the legislative requirements to practitioners. Dr Malouf acknowledged that he should have educated himself on the risks posed by alprazolam and other Schedule 8 medications, especially for medium or longer-term use in drug dependent patients.
4. Contrary to E/Prof Webster's view, we are not profoundly influenced in our assessment of Dr Malouf's conduct by the fact that he was ignorant of the legislative requirements. While his conduct is not as culpable as it would have been if he had deliberately flouted those requirements, the risks to the patients and the community are the same. The withdrawal guidelines point out that prescribing benzodiazepines to polydrug users poses serious risks. One reason for the legislative requirements was the published risks of overdose and overdose deaths when benzodiazepines are used in conjunction with opioids. Dr Malouf was prescribing Schedule 8 medications without complying with the statutory requirements for well over two years to nineteen patients.
5. None of the measures Dr Malouf took effectively mitigated the risks of prescribing alprazolam or other Schedule 8 medications for this cohort of patients. There was no evidence that charging a $10 fee discouraged new or existing patients from continuing to attend to obtain a prescription for alprazolam. Furthermore, Dr Malouf repeatedly accepted excuses from patients or ignored warning signs from hospitals and other professionals. For example, in his notes of 2 October 2015, Dr Malouf records that a script for Avanza made out to Patient A had been presented to a pharmacy by another patient. Dr Malouf accepted the patient's explanation that he must have dropped it. Dr Malouf even continued prescribing to Patient E after he said he was buying heroin off the street.
6. Dr Malouf submitted that continuing to prescribe alprazolam after the PRU visit is a mitigating factor because he did not put his career before his patients. In our view, it is an aggravating factor because he was on notice both by letter and as a result of phone conversations that he needed to obtain authorities. While we accept that it was not advisable to immediately stop prescribing to these patients, there were other options. The PRU suggested that he contact the DASAS but he did not do so. Nor did he apply for an interim authority while he obtained a report from a psychiatrist. (Other options which were not communicated to Dr Malouf at the time but which were available, were to convert the dose to an equivalent dose of diazepam or to refer these patients to another general practitioner and/or their methadone prescriber.) Dr Malouf's only response was to attempt to obtain reports from psychiatrists. He now admits that he should have sought further assistance and come to some agreement with the PRU.
7. Unsatisfactory professional conduct may relate to a person's knowledge, skill or judgment. For these particulars, it is Dr Malouf's knowledge and judgment that is significantly below the standard. He should have known that he needed an authority to prescribe Schedule 8 drugs. We accept that he did not know, but he should nevertheless have exercised judgment in prescribing to the 14 patients who he knew or ought to have known were drug dependent. Instead, he prescribed to these patients with almost no understanding or consideration of the risks involved. Consequently, each of these particulars amounts, at least, to unsatisfactory professional conduct.
8. The HCCC submitted that each of the particulars we have been discussing also constitutes professional misconduct. For reasons which are not entirely clear to us, the HCCC alleged that Complaint 13(f) (prescribing alprazolam when Dr Malouf knew or ought to have known that Patient M may have had a drug dependency) constituted unsatisfactory professional conduct, not professional misconduct.
9. The HCCC also submitted at the hearing that Dr Malouf's failure to pursue other options after 1 February 2016, by itself, constitutes professional misconduct. The complaint itself does not allege that Dr Malouf's conduct after 1 February 2016 is more egregious than his conduct before that time. For that reason, we have considered Dr Malouf's conduct over the entire period in determining whether it amounts to professional misconduct.
10. In Chen v Health Care Complaints Commission [2017] NSWCA 186 Basten J explained at [20] that: The term "professional misconduct" does not have a specific meaning; it is merely a category of "unsatisfactory professional conduct" which is sufficiently serious to justify suspension or cancellation.
11. In Health Care Complaints Commission v Dr Gow [2008] NSWMT 2 the Medical Tribunal made the following comment in relation to the predecessor to s 139E, s 37 of the Medical Practice Act 1992 (NSW): The Tribunal is satisfied that the determination of whether conduct amounts to professional misconduct has as its starting point, an objective assessment of the practitioner's conduct against the standard. The Tribunal is of the view that in coming to a decision about whether conduct is " sufficiently serious " to justify the sanction of de-registration, circumstances which bear on that objective assessment of that conduct may properly be taken into account.
12. Whether Dr Malouf's conduct is "sufficiently serious" to justify suspension or cancellation depends on "an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct": Chen v Health Care Complaints Commission [2017] NSWCA 186 at [20].
13. By describing the risks of combining benzodiazepines with other centrally acting agents as merely raising "safety concerns", E/Prof Webster understated the significance of those risks. We agree with the dependence guidelines, as to the degree of risk, in particular with the statement that "those with a history of substance misuse may be more vulnerable to major harms." The withdrawal guidelines are even more definitive. "Prescribing benzodiazepines to polydrug users poses serious risks."
14. We have taken into account Dr Malouf's conduct before 1 February 2016 and his conduct after that date. He was ignorant of the legislative requirements in the earlier period, but the significant risks to patients outlined in the dependence and withdrawal guidelines, persuades us that his conduct justifies suspension or cancellation.
15. Dr Malouf's conduct after 1 February 2016 is even more egregious because he knew he was in breach of the legislative requirements and continued to prescribe. While we may not have regarded a single instance or isolated instances of failing to obtain an authority as professional misconduct, when considered together (and when considered with other conduct identified later in these reasons), the conduct is of a sufficiently serious nature to justify suspension or cancellation.
16. In our view, in all the circumstances, each particular alleging a breach of the legislative requirements to obtain an authority constitutes professional misconduct. Someone of Dr Malouf's training and experience treating this cohort of patients should have known that an authority was required. In addition, each of the particulars alleging that Dr Malouf prescribed a Schedule 8 drug to 14 patients where he knew or ought to have been aware that the patient may have had a drug dependency, constitutes professional misconduct.
17. The risks of prescribing drugs of addiction to patients who are drug dependent are significant. Those risks include overdose and overdose deaths. Again, a single instance or isolated instances of Dr Malouf prescribing to that cohort of patients may not have constituted professional misconduct, but when considered together, the conduct is of a sufficiently serious nature to justify suspension or cancellation.
18. Cumulatively, the following complaints constitute professional misconduct: Complaint 1(f); Complaint 2 (f); Complaint 3(i); Complaint 4(f); Complaint 5(i) and (j); Complaint 6(i); Complaint 7(f) and (g); Complaint 8(i) and (j); Complaint 10(f) and (g); Complaint 11(f) and (g); Complaint 12(f) and (g); Complaint 13(e) and (f); Complaint 14(f) and (g); Complaint 15(f) and (g); Complaint 16(f) and (g); Complaint 17(f) and (g); Complaint 18(f) and (g); Complaint 19(j) and (k); and Complaint 20(f) and (g).

Prescribing when patient enrolled on an Opioid Treatment Program (OTP)

Summary of allegations

1. The HCCC alleged that for nineteen patients, Dr Malouf prescribed alprazolam in circumstances where the patient was enrolled on the NSW Opioid Treatment Program. For Patient I, Dr Malouf prescribed diazepam in circumstances where the patient was enrolled on the NSW Opioid Treatment Program. OTPs include methadone maintenance therapy as a treatment option for people addicted to opioids, particularly heroin.

Legal requirements or guidelines

1. These particulars are related to the particulars alleging that Dr Malouf "knew or ought to have been aware that the patient may have had a drug dependency." If Dr Malouf knew that a patient was on an OTP that would have alerted him to the fact that the patient was addicted to opioids. In recognition of the risks of prescribing benzodiazepines to this cohort of patients, a letter from the authorised OTP provider supporting benzodiazepine treatment must be attached to an application for an authority to prescribe alprazolam. Transferring this aspect of care to an OTP provider or, at least, sharing information and care is best practice.
2. The principle in the dependence guidelines which is most relevant to these allegations is principle 4: 4. Avoid prescribing benzodiazepines to patients with comorbid alcohol or substance use disorders or polydrug use. GPs should consider seeking specialist opinion in the management of these patients. Patients who use two or more psychoactive drugs in combination (polydrug use) and those with a history of substance misuse may be more vulnerable to major harms.
3. The dependence guidelines note that when benzodiazepines are combined with central nervous system (CNS) depressants such as alcohol and opioids, which includes methadone, patients are at risk of respiratory depression, heavy sedation, coma and death.
4. The key messages in the dependence guideline are not to initiate prescription benzodiazepines of any kind, including alprazolam and, for patients who are already taking benzodiazepines, to "reduce and cease prescription" in a supervised manner. Therapeutic monitoring and prescribing should only occur if GPs have extensive experience or in conjunction with specialists: Apart from the risk of overdose, harms associated with polydrug use (particularly among people who inject drugs) include a higher rate of infectious and metabolic complications, as well as psychiatric, social and forensic consequences, with an increased cost to society. People who are participating in medication-assisted opioid dependence treatment, and who take benzodiazepines regularly or intermittently, tend to do very poorly, with higher risk of adverse outcomes. (Emphasis added.) There is little evidence to guide practitioners in the management of this often difficult-to-treat population. However, when treating polydrug users, it is recommended not to initiate prescription of benzodiazepines. For polydrug users already taking them, it is recommended to reduce and cease prescription of benzodiazepines in a supervised manner. Therapeutic monitoring and prescribing should only occur if GPs have extensive experience in addiction medicine, or in conjunction with specialist supervision. When working with known polydrug users, it is essential to collaborate with local drug and alcohol services, and to provide clear guidelines on the accepted harm-minimisation strategies. Clear boundaries are crucial.
5. The experts had differing opinions about the highlighted statement at the end of the first paragraph. Footnote 21 which follows that sentence, cites an article written by the Mental Health and Drug and Alcohol Office (MHDAO) titled, "NSW Opioid Treatment Program: Clinical guidelines for methadone and buprenorphine treatment", Sydney, 2006.
6. E/Prof Webster referred to a study in the United Kingdom, which he said, was inconsistent with the highlighted statement in the guidelines. In his report of 6 March 2018, E/Prof Webster wrote: In contradistinction to prevailing views about the hazards of benzodiazepines and opioids, a retrospective general practice study in the UK, found that continuing benzodiazepines in patients on long-term opioids resulted in lower death rates and higher retention in treatment compared with patients who received benzodiazepines briefly or not at all and that patients who left the program had increased mortality.
7. The practice study to which E/Prof Webster was referring is titled, "Benzodiazepine maintenance in opiate substitution treatment: good or bad? A retrospective primary care case-note review" by Adam Bakker and Emmanuel Streel, published in the Journal of Psychopharmacology 2017, Vol 31(1) 62-66. That article noted that in the United Kingdom, problematic benzodiazepine use continues in 30-50% of patients engaged in methadone maintenance treatment.
8. The authors sought to minimise withdrawal symptoms for these patients by using "a steady, controlled, legal supply of benzodiazepines". At p 65, they concluded that, in their study, patients on opiate substitution treatment (OST) who were co-dependent on benzodiazepines "appear to do better when OST is combined with BMT (benzo maintenance treatment), as regards both treatment retention and mortality". E/Prof Webster agreed with the authors of the UK article that supplying a steady, controlled, legal supply of benzodiazepines could reduce adverse outcomes for these patients.
9. The authors of the UK article acknowledged that the predominant expert opinion is that the aim should be to withdraw these patients from benzodiazepines. E/Prof Webster agreed that the authors' conclusion is "in conflict with the predominant expert opinion". Nevertheless, Dr Malouf submitted that the 2006 Australian article at footnote 21 of the dependence guideline is inconsistent with the more recent UK article and consequently outdated.
10. We note that the benzodiazepine used in the UK study was diazepam up to 30 mg/day or clonazepam up to 8 mg/day. Alprazolam was not used. E/Prof Webster agreed that alprazolam is significantly more potent than other benzodiazepines and there is a higher risk of it interacting with other drugs such as alcohol and opiates. Dr Deed agreed that alprazolam presents higher risks and is more likely to be abused than diazepam because it gives quicker relief.
11. Dr Deed's view was that the research reflected in the UK article was carried out in a particular setting that is not comparable to Dr Malouf's practice. He noted that the paper was based on a shared care model where opioids and benzodiazepines are prescribed in the same practice so that everyone knows what is being prescribed. For most of the time Dr Malouf was prescribing Schedule 8 drugs, he did not know that his patients were on an Opioid Treatment Program. Furthermore, the dosages he was prescribing were significantly higher than for the research patients.
12. We are not persuaded that the highlighted statement in the dependence guidelines is outdated or incorrect based on the UK study. In significant respects, that study does not mirror the Dr Malouf's practices. In addition, there is a higher risk that potent benzodiazepines like alprazolam will interact with other drugs such as methadone.

Dr Malouf's response

1. Dr Malouf's general response was that he did not admit these particulars; however, he did not deny that every patient was on an OTP. For some patients, Dr Malouf asked them whether they were on an OTP, but more often, he would just ask what other medications they were taking. Dr Malouf admits that he took no steps to contact any organisation to find out whether a patient was on a methadone program. He also says that he did not realise that he could have found out whether a patient was on an OTP.
2. Dr Malouf's view was that co-prescribing alprazolam or diazepam with opioids was not contra indicated, but that caution should be exercised.
3. Dr Malouf did not know Patient M was on an OTP. For Patients A, B, C, E, G, H, J, K, P, S and T, he did not know that they were on an OTP until a few weeks before the PRU visit on 30 March 2016. For these patients he then began the process of handing over this aspect of the patient's management to the OTP prescriber. He agreed that he should have contacted the patients' methadone provider when he first found out. That was necessary to give that patient a reasonable standard of care.
4. Dr Malouf acknowledged his failings in relation to Patients Q, I, R and L. He found out that those patients were on an OTP on 28 November 2014, 15 December 2014, 6 November 2014 and 8 September 2015, respectively. He recognises that in each case he should have communicated with the nominated methadone prescriber to discuss case management in detail. At the time, he thought that his "tight monitoring and control measures" meant that his prescribing was justified. He now realises that he was mistaken.
5. Patient D told Dr Malouf that he stopped being on an OTP in 2010 and continued to deny that he was on such a program on 26 February 2016. For Patient J, Dr Malouf knew she was on the OTP on 31 January 2016. He wrote to her methadone prescriber at that time but did not receive a response.
6. On 25 February 2015, Dr Malouf became aware that Patient N was on the OTP and wrote to his methadone prescriber at Fleet Street OTP. He says he wrote a further five times between February 2015 and March 2016, but received no response. Dr Malouf had known Patient O was on an OTP since 2013, but did not follow up as his psychiatrist advised that he had stabilised him on alprazolam. Dr Malouf wrote to his methadone provider at the Fleet Street OTP on 17 July 2015 but did not receive a reply. He maintains that he exercised "tight control and due care throughout".

Experts' opinion

1. In response to a question from the Tribunal, E/Prof Webster agreed with the proposition that no doctor would recommend prescribing alprazolam as a benzodiazepine maintenance therapy for patients on an OTP. He acknowledged that, for those patients, Dr Malouf should have attempted to contact the prescriber. When asked why he was more critical of his conduct when Dr Malouf knew the patient was on a methadone program, he merely noted that there are very few drug and alcohol programs run from public hospitals in NSW.
2. E/Prof Webster acknowledged that benzodiazepine use in patients on opioids is not best practice and should be avoided. He said that Dr Malouf should have known about the risks of prescribing alprazolam. He said, "A more 'tuned in' practitioner might have taken a proactive search for current, or previous, opioid substitution treatment."
3. For Patients I, L and Q, Dr Malouf knew they were on methadone but did not contact the methadone provider. E/Prof Webster regarded this as significantly below the standard but not as being serious enough to constitute unsatisfactory professional conduct. For Patient I, E/Prof Webster noted that no authority is required to prescribe diazepam. However, when Dr Malouf became aware that this patient was on an OTP, he should have either taken steps to withdraw her from diazepam or contacted the OTP prescriber and considered transferring this aspect of management to the OTP prescriber. E/Prof Webster's main concern was the lack of contact and shared care with the OTP prescriber. Both experts agreed that taking the history from a patient includes asking whether the patient is, or has been, on an OTP.
4. Dr Deed said that writing letters to OTP prescribers is not an adequate response. If Dr Malouf did not receive a reply to his correspondence, he should have rung them or got in touch some other way. While there is some reference to Dr Malouf contacting a case manager by phone on two occasions in 2015, there are no further details in the notes. In particular, despite the written correspondence, Dr Deed was critical of Dr Malouf's decision to prescribe alprazolam to Patient N and his failure to follow up with Patient N's opioid treatment provider. In Dr Deed's view, both failings are significantly below the standard expected and constitute professional misconduct.

Conclusion

1. As we have said, these particulars are closely related to the particulars we have addressed alleging that Dr Malouf "knew or ought to have been aware that the patient may have had a drug dependency". Furthermore, practitioners are expected to contact an OTP provider and obtain support for benzodiazepine treatment before it is initiated.
2. Dr Malouf should not have prescribed alprazolam or diazepam to patients who were enrolled in an OTP. He should have asked every patient in this cohort whether they were on an OTP and even if they denied it, he should have contacted the PRU to find out. We had evidence from the PRU that if a treating doctor inquired as to whether a patient of theirs was in an OTP, the PRU would tell the doctor whether the patient is, or has been, on the OTP and the current authority holder's contact details. We appreciate that Dr Malouf did not know he could obtain this information from the PRU.
3. When benzodiazepines are prescribed with opioids, including methadone, there is a risk of respiratory failure and death. Dr Malouf's knowledge and judgment is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. Continuing to prescribe alprazolam to Patients Q, I, R and L when he knew they were on an OTP is more serious. That conduct, when considered together with the conduct we have found to constitute professional misconduct, is of a sufficiently serious nature to justify suspension or cancellation.
4. In summary, the following particulars constitute unsatisfactory professional conduct: complaint 1(e), 2(e), 3(h), 4(e), 5(h), 6(h), 7(e), 8(h), 9(e), 10(e), 11(e), 12(e), 13(d), 14(e), 15(e), 16(e), 17(e), 18(e), 19(i) and 20(e). For patients Q, I, R and L, cumulatively, the following particulars constitute professional misconduct: Complaint 17(e) (Patient Q); Complaint 9(e) (Patient I); Complaint 18(e) (Patient R) and Complaint 12(e) (Patient L).

Summary of allegations

1. For each patient, apart from Patient I, the HCCC alleges that Dr Malouf prescribed alprazolam without conducting an appropriate assessment. For Patient O, the allegation is expressed as prescribing alprazolam "without conducting an appropriate assessment on 20 November 2013 when continuing to prescribe alprazolam." For Patient S, the allegation is that Dr Malouf did not conduct an appropriate assessment before prescribing alprazolam with Mirtazapine (an anti-depressant).
2. It is also alleged that Dr Malouf did not conduct an appropriate assessment before prescribing diazepam (Patients F and I); Paracetamol and codeine (Patient E); oxycodone and naloxone (Targin) (Patient H); fentanyl (Patient S) and alprazolam with Fluoxetine (an SSRI) (Patient T).

Legal requirements and guidelines

1. The dependence guidelines relevant to this particular are principles 1 and 2: 1. Prescription of benzodiazepines, as with any treatment, should be based on a comprehensive medical assessment; a diagnosis; thoughtful consideration of the likely risks and benefits of any medication, as well as alternative interventions; and a management plan derived through shared decision making and continual clinical monitoring. 2. GPs should be aware of the common concerns associated with benzodiazepines, such as potential dependence, withdrawal, problematic drug use (including diversion and misuse) and known harmful effects, including falls, potential cognitive decline and motor vehicle accidents. These risks should be discussed with patients.
2. The experts agreed with these guidelines. An appropriate assessment involves a comprehensive medical assessment, diagnosis and an assessment of the risks and benefits.
3. The application form for an authority to prescribe alprazolam asks the practitioner to consider whether the patient is "doctor shopping". If a patient is going to more than one doctor, that may be an indication that the person is drug dependent and/or is diverting or misusing drugs.

Overall response

1. Other than for Patients D and P, Dr Malouf maintains that he performed a proper assessment before prescribing alprazolam. Dr Malouf's initial assessment involved "taking a social and medical history from the patient over a period of approximately one hour using his clinical acumen." Dr Malouf diagnosed patients based on the history they told him, a visual assessment for characteristics such as a flat affect, unkempt or agitated and his clinical acumen. When diagnosing panic disorder, Dr Malouf did not use the Diagnostic and Statistical Manual (DSM) guide or any other diagnostic tool. He made his diagnosis "informally". Dr Malouf maintains that diagnostic tools are no more beneficial than his own method of assessment through discussion and clinical acumen.
2. Dr Malouf knew that Patient D was drug dependent and had used multiple benzodiazepines. Dr Malouf also acknowledged some failings in relation to the treatment of Patient P. He was known to the Doctor Shopping Hotline. Dr Malouf characterised this as being "in a minimal way and consistent with his story". He considered Patient P to be very open about his drug taking. Dr Malouf thought providing him with a "medical home" would be safe and beneficial. For Patient R, Dr Malouf was aware of some "very limited drug misuse" and acknowledges that his approach was "less than ideal".
3. Dr Malouf acknowledges that it was "less than ideal" to prescribe alprazolam and Fluoxetine, an anti-depressant. He says he has spent considerable time reflecting on the errors and correcting his care and treatment where necessary.
4. He acknowledged that for Patients B, E and J, contacting their former GP would have been ideal, but they had either retired or the patient could not recall their name.

Patient A

1. Dr Malouf recorded that in early 2014, Patient A had been viciously assaulted by a gang outside a shopping centre and, since then, had experienced "anxiety/depression/panic attacks/flashbacks/agoraphobia". He was not known to the Doctor Shopping Hotline. Another general practitioner, Dr Low, had prescribed Patient A with Xanax 2mg 1 BD for three prescriptions, then stopped. Since then, he told Dr Malouf he had been buying off the street. He had also been on Avanza (an anti-depressant) 45mg 1 nocte for 12 months. Dr Malouf re-commenced Patient A on alprazolam and Avanza with the intention, he said, of "possibly" reducing and weaning alprazolam in due course. Dr Malouf prescribed one weeks' supply and asked him to return after that.
2. Despite the fact that Dr Malouf recorded the name of Patient A's previous general practitioner, he did not ask him to forward Patient A's clinical notes. While Dr Malouf called the Doctor Shopping Hotline, there is no record of any contact with prior prescribers, the Drug and Alcohol Specialist Advisory Service (DASAS) or the Methadone Advice and Conciliation Service (MACS).

Patient B

1. Dr Malouf recorded that Patient B was "feeling stressed-depressed with some panic attacks". Patient B had previously been given some Xanax 2mg for use as needed and said he found it helpful. His former GP had "retired" and he was "visiting friends in Parramatta today". Dr Malouf agreed that it might have been relevant to ask why he was travelling to Parramatta when most patients see a doctor closer to their residence or their work. He conceded that one possibility was that they are doctor shopping.
2. Dr Malouf says he gave Patient B "support, encouragement and counselling". He has no formal training in Cognitive Behaviour Therapy but thought he was providing elements of CBT in his counselling. He did not he see formal CBT as necessary.
3. Dr Malouf diagnosed "anxiety-depression-panic". Dr Malouf prescribed 2mg of alprazolam daily (one weeks' supply) and asked him to return. He was not known to the Doctor Shopping Hotline.

Patient C

1. Dr Malouf recorded that Patient C had been in gaol on and off for about 5 years but had been out for 5 years. He diagnosed "anxiety-depression" as one of his conditions and added that he had multiple physical issues. Patient C did not have a diagnosis of panic attacks. On 1 June 2015, Dr Malouf prescribed Valium 5mg. He reported feeling better and the prescription was continued. Patient C told Dr Malouf that 5mg of Valium was inadequate and that he had trialled Kalma 2mg and felt "much better". On 7 October 2015, Dr Malouf changed Patient C's Valium to Kalma "due to an inadequate response to Valium and an increased Zoloft dosage". Dr Malouf said that a detailed discussion would have taken place about taking alprazolam, but it was not recorded. Dr Malouf agreed that one reason he prescribed Kalma was that the patient asked for it.

Patients D

1. Patients D and I had been long-term patients and Dr Malouf felt that he knew their issues well. Patient D had been seen by other members of the practice in 2008 and 2009.
2. Patient D had spent time in gaol where he was sexually assaulted. Dr Malouf recorded that Patient D had panic attacks in 2013 and "some degree of former drug dependence with long term use of various benzodiazepines". Patient D told Dr Malouf that he had tried multiple benzodiazepines with limited effect but found Kalma the most beneficial. Dr Malouf prescribed alprazolam 2mg (50 tablets) based on the patient's reference to panic attacks. Dr Malouf did not record in his notes how the panic attacks were manifested but says he would have discussed it.

Patient E

1. Patient E had spent time in gaol. Dr Malouf diagnosed him with anxiety, depression, panic attacks, post-traumatic stress disorder and agoraphobia. He had had some recent periods of homelessness. Patient E admitted occasionally buying heroin off the street, as well as a small number of benzodiazepines and said, "Xanax (was) the best". He suffered chronic back pain and other serious health issues. Dr Malouf acknowledged that Patient E had major issues.

Patient F

1. This patient was first seen on 27 April 2015. He had spent time in gaol and had been out for only two weeks when he first saw Dr Malouf. He told Dr Malouf that his GP had retired. He reported that he "copped a lot of 'sledging' in gaol and had been bashed some years back". Dr Malouf recorded that he "tends to be anxious with some mild panic episodes and always watching his back". He said he had been prescribed Seroquel in gaol (an anti-psychotic). He was obtaining Xanax illegally in gaol occasionally. Dr Malouf did not ask him about any withdrawal symptoms from Xanax.
2. On 28 May 2015, Dr Malouf prescribed Patient F 50 alprazolam tablets, 2mg per day. Dr Malouf's aim was to stabilise him on alprazolam.

Patient G

1. Dr Malouf diagnosed Patient G with "anxiety, depression and agoraphobia". She did not have a diagnosis of panic attacks. She admitted to a prior history of benzo dependence which she had formerly overcome but had become dependent again in the last six months. Three months previously, she had started buying Xanax off the street but said that supply was erratic and expensive. She was keen to be "helped off" alprazolam.

Patient H

1. Patient H lives in Mascot and was seen by Dr Malouf for the first time in May 2015. Dr Malouf could not remember why this patient was coming to see him in Parramatta even though he lived in Mascot. He reported "anxiety/panic/depression/insomnia" and had significant pain from motorbike accidents. He had had two heart attacks in 2013. Patient H was not on any medications apart from "aspirin and a couple of others" at that time. He initiated a low dose of Targin 2.5mg/1.25mg 1 in the morning and two at night, and provided him with a script for 28 tablets. At the following visit, Patient H admitted to buying Xanax off the street occasionally to help him sleep. Dr Malouf then adjusted the Targin to 5mg/2.5mg, one tablet in the morning (script for 28 tablets) and added Kalma 2mg - one at night (script for 7 tablets). Dr Malouf judged Kalma to be safe and required due to his current street usage.

Patient I

1. Dr Malouf diagnosed Patient I with "anxiety, depression and panic attacks". She had long-term benzo dependence of Valium 5mg daily with occasional extras, as needed. She had been a long-term patient and re-connected with the practice on 12 November 2011. Dr Malouf continued Valium 5mg, one tablet per day and gave her 50 tablets. He asked her to come back before they were finished for further assessment. He judged that this dose would be both safe and required. Dr Malouf acknowledges some failings with Patient I. Although she did not have a psychiatric issue, she was taking Diazepam long term when she came to see him.

Patient J

1. When first seen on 30 June 2015, Dr Malouf diagnosed anxiety, depression, panic attacks and post-traumatic stress disorder. She had suffered repeated physical and sexual attacks including being raped on several occasions. She reported being on Kalma 2mg three times a day from a doctor in a northern Sydney suburb. She was staying there for a while but is now back in the Parramatta area and said it was too far to go to her previous GP. Dr Malouf accepted her current benzo usage and desire for help. He prescribed Kalma 2mg twice a day and gave her two weeks' supply (42 tablets).

Patient K

1. At the first consultation on 22 May 2015, Dr Malouf diagnosed Patient K with "anxiety, depression, panic attacks, nightmares and agoraphobia". He had spent five years in gaol where he was sexually abused. He was on Avanza (an anti-depressant) in gaol. He had been getting some Xanax 2mg from his partner's father on occasions and said it was helpful. Dr Malouf initiated Kalma 2mg, one per day and gave him a weeks' supply (7 tablets).

Patient L

1. Patient L was recommended to Dr Malouf by her partner, Patient C. Dr Malouf diagnosed her with "anxiety, depression and panic attacks". At the initial consultation on 27 April 2015, she was on Seroquel (an anti-psychotic medication) and Avanza (an anti-depressant). Dr Malouf recommended halving the dose of Seroquel and continuing with Avanza. Five weeks later, Dr Malouf reported that Patient L was much brighter and had stopped taking Seroquel. As well as Avanza, she "admitted to taking the occasional Kalma 2mg off her partner to good effect". Following discussions with Patient L, Dr Malouf stopped Seroquel, continued with Avanza 45mg and trialled Kalma 2mg, one tablet at night. He gave her a script for 14 tablets.

Patient M

1. Dr Malouf diagnosed Patient M, who had attempted suicide in 2010 and 2013, with "anxiety, depression, panic attacks and agoraphobia". Patient M came to see Dr Malouf on 14 January 2016, on the recommendation of another patient. Patient M told Dr Malouf that he had tried many medications including Valium but none had helped. He said he had used Xanax on and off, either prescribed by doctors or obtained from friends and neighbours. He found them helpful. Dr Malouf initiated Kalma 2mg, one daily and prescribed a weeks' supply (7 tablets).

Patient N

1. At the first visit on 12 February 2015, Patient N reported that he had been "mixed up in a group where he was sexually abused and exploited", and ended up with "post-traumatic stress, nightmares, anxiety/panic attacks and depression". He reported last using heroin in 2005 and had used marijuana.
2. Patient N had "well controlled schizophrenia, previously diagnosed and treated by a psychiatrist". Patient N was previously a patient of a visiting psychiatrist at Parramatta Mission, who had prescribed Kalma 2mg per day for the last 12 months. He had also been prescribed mirtazapine. He wrote a transfer letter to Dr Malouf. He had also been advised by Dr Lam of the Centre for Addiction Medicine (CAMS) at Cumberland Hospital to find a regular GP. Dr Malouf prescribed Kalma "as a continuation of the then current treatment" from the psychiatrist. On 12 February 2015, Dr Malouf wrote to Dr Lam saying that he was Patient N's new GP and asking him to keep him "in the loop" with significant results and investigations to date.

Patient O

1. Patient O had been a previous patient in 2003 and 2004 and returned in 2013. In 2011, another GP, Dr Alagan, referred Patient O to a consultant psychiatrist, Dr Sharah. Dr Sharah told Dr Alagan that he would "support him with Xanax" for a time and then gradually reduce it. In November 2011, Dr Sharah said Patient O had stabilised on Xanax 2mg x 1 ½ /d (previously 4/d). Dr Malouf diagnosed Patient O with anxiety, depression and panic attacks and agreed to continue Kalma 2mg 1 ½ per day. He prescribed 50 tablets at the initial consultation, one months' supply. When Patient O saw Dr Malouf on 20 November 2013, he decided to continue with alprazolam.

Patient P

1. Dr Malouf diagnosed Patient P with anxiety, depression and panic attacks. He had been sexually abused as a child and had had a brief period of homelessness. He said his GP had semi-retired, leaving him to see a string of doctors at the clinic. He has trialled many medications over the years - Valium, Xanax, Endep and Seroquel - and reported that "Xanax has been the best". On 18 July 2014, at the first consultation, Dr Malouf initiated Kalma 2mg 1 per day and prescribed 50 tablets. Dr Malouf judged that this dose would be safe given his current usage.

Patient Q

1. At the first consultation on 28 August 2014, Dr Malouf diagnosed anxiety, depression and panic attacks related to childhood sexual abuse. Dr Malouf prescribed Kalma 2mg and gave him 50 tablets, because he judged him as being credible, straight and engaged, and felt he would be reliable with this quantity. Dr Malouf says that was a judgment call as to the most appropriate dose.
2. Patient Q was admitted to Westmead Hospital on 6 September 2015 having taken an overdose of tramadol (an opioid used to treat moderate to severe pain) and injecting methadone. The hospital notes record that he had been found unresponsive with alprazolam and oxycodone in his pocket. Dr Malouf received an Emergency Department Assessment from Westmead Hospital for Patient Q on 17 September 2015, the day after his first consultation with that patient. It refers to the patient's "chief complaint" as "drowsy, poor concentration - poor historian". The document goes on to state that he "admits to injecting methadone tonight" and when asked whether he had suicidal intentions, he said, "if I answer, I don't want to end up in a psych ward".

Patients R

1. Dr Malouf diagnosed Patient R with "anxiety, depression and panic attacks". He had been homeless for years and gave a history of some drug usage and time in gaol. He admitted to long-term use of Xanax "from doctors and off the street". He said he was taking Xanax 2mg per day and that it was very helpful. On 26 November 2014, at the first consultation, Dr Malouf prescribed him with a weeks' supply of Kalma 2mg (14 tablets).

Patient S

1. Patient R and Patient S are brothers. At the first consultation on 25 September 2014, Dr Malouf diagnosed Patient S with "anxiety, depression and panic attacks" related to marital breakup and concern for his children. He had ongoing back pain. His previous GP, who had moved overseas, had recommended Dr Malouf. He said he had previously been on Kalma 2mg a day for eight years since his marriage had failed. Dr Malouf said he continued to prescribe Kalma at the same dosage. He gave him 50 tablets because he had been on the medication and had been stable for many years.
2. On 4 June 2015, Patient S told Dr Malouf that a friend had given him a Durogesic patch (fentanyl) for his ongoing back pain. He described a "dramatic benefit". Dr Malouf agreed to trial fentanyl 50mcg 1/3-4 days (PRN) in cold weather only and to monitor closely. On review two weeks later, he was alert and standing upright and said his pain had fully settled. Dr Malouf says he was "within weeks" of finally ceasing the fentanyl patches altogether by the time of the PRU visit.

Patient T

1. On 24 June 2015, at the first consultation, Dr Malouf diagnosed Patient T with "anxiety, depression, panic attacks and agoraphobia as well as some mild obsessive compulsive disorder (OCD) tendencies". She had been a victim of domestic violence and had self-harmed many times. Each of her four children had been removed from her care. She reported "some benzo use off the street - Valium no good, but Xanax helpful". She was using two to three tablets a day but supply was unreliable and expensive. She was seeing Dr Malouf on the recommendation of her current partner, Patient K.

Doctor Shopping Hotline

1. As part of his assessment, Dr Malouf routinely telephoned the Prescription Shopping Program, commonly referred to as the Doctor Shopping Hotline. The Doctor Shopping Hotline identifies patients who have seen a large number of practitioners, and received prescriptions in excess of an identified criteria, in the preceding three months.
2. Three patients, Patients D, P and S, were known to the hotline. In relation to Patient D, Dr Malouf "judged him to be credible and monitored him very closely over time". Patient P was known, but, according to Dr Malouf, "it was for a 3 month period finishing 3 months earlier, there were not many doctors, the medication numbers were low and it was entirely consistent with his story on presentation".
3. Patient S was not known initially but when Dr Malouf called the hotline 7 months after the first consultation, he was known to them. There was evidence of Patient S obtaining Valium and Serepax elsewhere. Dr Malouf said he had hoped to raise the issue with Patient S but did not get an opportunity to do so because of his acute distress on the next two visits. Several visits later, on 8 October 2015, Dr Malouf transferred his medications directly to the pharmacist for daily pick up in the case of Kalma and three day pick up in the case of Durogesic (fentanyl). Dr Malouf exercised what he called "a little judicious latitude".

The question

1. The question the HCCC asked of the experts was, "Did Dr Malouf conduct an appropriate assessment of this patient prior to prescribing alprazolam 2mg? If not what would have constituted an appropriate assessment in the circumstances?"

Narrative history and obtaining clinical notes

1. Dr Deed considered it important to obtain a comprehensive past history from a patient, including history of drug use at the first consultation or very soon after that. Based on that history, an assessment can be made of both past and future risks. The history is taken by questioning the patient and by obtaining previous medical records. Complex patients, sometimes referred to as "red flag patients" are not necessarily reliable historians. Consequently, Dr Deed would try to find out who the patient had obtained health care from in the past and make further inquiries from those people.
2. In E/Prof Webster's view, a full history does not have to be taken at the first consultation because that consultation is mainly to establish trust and rapport. When asked what history and assessment a GP should take before prescribing alprazolam, E/Prof Webster said he would like to see a general physical examination including blood pressure and weight. But conducting a full physical examination at the first consultation is not as important as engaging empathetically at that stage. E/Prof Webster highlighted the fact that Dr Malouf's first consultations lasted for an hour or more and the follow up consultations were for 30 minutes.
3. Dr Deed said it was imperative to obtain the patient's previous clinical notes. E/Prof Webster regarded it as "highly important" to do so. E/Prof Webster emphasised that it is often difficult to find out the names of previous treating doctors and to access hospital records. He conceded that a previous GP is obliged to provide records but suggested that, for "many reasons", they could be difficult to obtain. Dr Deed regarded Dr Malouf's failure to obtain these records as being significantly below the standard expected. E/Prof Webster conceded that Dr Malouf should probably have asked for the previous GPs' notes.
4. Patient A first consulted Dr Malouf on 13 August 2015. Dr Malouf recorded details about his smoking and alcohol consumption. He told him his previous GP was Dr Low of Telopea. Dr Malouf did not contact Dr Low, because he assumed Dr Low had stopped supporting him. E/Prof Webster's initial response to Dr Malouf's assessment of Patient A was that it was "below standard" because of the lack of any recording of physical findings. He amended that assessment to "borderline standard" when he read Dr Malouf's transcribed notes and his written responses to the complaint. On reflection, E/Prof Webster thought that Dr Malouf was addressing this patient's needs adequately.

Using protocols or diagnostic classifications

1. Dr Deed said that GPs need to use standardised protocols when diagnosing common mental health conditions. Taking a narrative history is one component of assessing a patient but much more is often needed including specific diagnostic tools, to confirm the patient's assertions.
2. E/Prof Webster said the narrative is far more important than diagnostic classifications. He regarded it as ideal to obtain a detailed history, including a full account of the patient's social circumstances and psychological state, but emphasised the difficulties in doing. He considered it more important to establish trust in the first consultation. E/Prof Webster said that while it is desirable to ask a new patient presenting with depression and anxiety, about his sleeping and eating patterns, it is not necessary. Recording symptoms is not very helpful. The impact the person's condition has on their daily functioning is more important.

Overall assessment

1. Dr Deed's view was that Dr Malouf's conduct was significantly below the standard and invited his strong criticism, with the exception of his prescribing of diazepam 5mg to Patient I, which did not attract his strong criticism. E/Prof Webster's view was that Dr Malouf's actions were below the standard, but not significantly below the standard, for Patients, P, R, and S and were "borderline" standard for Patients A and B.

Conclusion

1. In our view, Dr Malouf's clinical assessment of these patients was inadequate, not because he failed to use diagnostic tools or did not adequately diagnose the patients' underlying mental health conditions. While his assessment was based, for the most part, on self-reporting, there is no real doubt that the patients had the conditions he diagnosed. He should have obtained a more detailed family history and conducted a physical examination, but those failings do not amount to unsatisfactory professional conduct. Similarly, he should have obtained previous clinical notes for new patients. Those records would confirm or contradict the narrative history. However, that failing does not, in itself, constitute unsatisfactory professional conduct.
2. The real problem was in Dr Malouf failure to expressly diagnose and treat the patients' substance use disorders. We have previously outlined the risks of prescribing drugs of addiction to patients with substance use disorders. A common risk associated with benzodiazepines, especially alprazolam, is potential dependence, problematic drug use (including diversion and misuse) and known harmful effects including falls, potential cognitive decline and motor vehicle accidents.
3. Rather than seeking guidance from addiction specialists or other services, Dr Malouf prescribed a potent drug of addiction to these patients. He knew or should have known that his patients had, or were at risk of having, a substance use disorder. Patients D, P and S were known to the Doctor Shopping Hotline. Many patients admitted buying drugs off the street or obtaining drugs from partners or other relatives. Some patients had a history of suicidal intention and many were at risk of other serious harm, evidenced by hospital admissions and aberrant behaviour.
4. For each patient, except Patient I (and Patient F in relation to prescribing diazepam), Dr Malouf's failure to conduct a proper assessment before prescribing the specified medication, constitutes unsatisfactory professional conduct. For Patients A, B, D, P, R and S that failure, when viewed together with other conduct, is of a sufficiently serious nature to justify suspension or cancellation.
5. In summary, the following complaints constitute unsatisfactory professional conduct: complaints 3(a), 5(a) and (b), 6(a), 7(a), 8(a) and (b), 10(a), 11(a), 12(a), 13(a), 14(a), 15(a) and 17(a). Cumulatively, the following complaints constitute professional misconduct: 1(a), 2(a), 4(a), 16(a), 18(a), 19(a) and (b).

Prescribing otherwise than for an appropriate therapeutic purpose

Summary of allegations

1. These particulars allege that, for each patient except Patient I, Dr Malouf prescribed alprazolam "in circumstances where it was not prescribed for an appropriate therapeutic purpose". For Patient I the allegation was that Dr Malouf prescribed diazepam in circumstances where it was not prescribed for an appropriate therapeutic purpose. The HCCC also alleged that Dr Malouf prescribed Paracetamol and Codeine (Patient E); fentanyl (Patient S); and fluoxetine with alprazolam (Patient T) where it was not prescribed for an appropriate therapeutic purpose.
2. The particulars are framed in the negative. The inference is that Dr Malouf prescribed these medications for a non-therapeutic purpose. The HCCC did not identify that purpose.

Legal requirements and guidelines

1. There are guidelines, including the Therapeutic Guidelines, the dependence guidelines and the withdrawal guidelines which deal with the circumstances in which medications should be prescribed. In addition, the product information for alprazolam includes the indications for its therapeutic use. That document states that alprazolam is indicated for the treatment of anxiety and panic disorder: Anxiety: the short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression; Panic Disorder: the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.
2. The product information goes on to state that: Although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation.
3. Despite that statement, the experts agreed that the current indications for therapeutic use of alprazolam are for short-term use. Based on this information, our understanding is that an appropriate therapeutic purpose for prescribing alprazolam is for the short-term treatment of anxiety and panic disorders. Diazepam is used for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Fentanyl is an opioid indicated in the management of chronic pain requiring opioid analgesia. Fluoxetine (brand name Prozac) is used to treat conditions including depression, agoraphobia, anxiety, and panic disorder.

Dr Malouf's response

1. Dr Malouf did not admit this particular for any patient. He said he always prescribed alprazolam within the product information therapeutic indications. While he did not know alprazolam was a Schedule 8 drug, he says he took considerable measures to control and monitor its use. He gave that response in relation to every patient except Patient I. Further information was provided for Patients A, E, F, I, and T.
2. Dr Malouf did not admit that he prescribed Paracetamol and codeine (500mg and 30mg) to Patient E for a non-therapeutic purpose. Dr Malouf prescribed Patient F diazepam and alprazolam sequentially. He denies that he prescribed diazepam for an inappropriate therapeutic purpose. In relation to Patient I, Dr Malouf's response was that he fulfilled the therapeutic indications for prescribing diazepam.
3. For Patient T, Dr Malouf acknowledged that he did not fully appreciate the risks of prescribing alprazolam with fluoxetine. He intended to treat the patient's depression and help her "transition into a preparedness to wean her alprazolam". He took the precaution of starting her on a half dose for the first two weeks.
4. Dr Malouf said that by prescribing alprazolam he was reducing the risk of Patient A buying off the street.

Experts' opinions

1. The question the HCCC asked the experts was: "Did Dr Malouf prescribe each of the above drugs to this patient for an appropriate therapeutic purpose?"
2. E/Prof Webster's overall response to the particulars about prescribing for a purpose that was not therapeutic was to endorse Dr Malouf's approach of stabilising the patient on medication with the aim of achieving gradual withdrawal. While he accepted, as a general proposition, that prescribing should accord with the therapeutic indications in the product information, he said the patients in this cohort are not "average" patients. E/Prof Webster's view was that Dr Malouf's conduct fell below the standard to a significant degree for Patient A, but not to a significant degree for Patients B, C, D, L and Q.
3. Dr Deed's view was that this conduct fell significantly below the standard and invited his strong criticism, with the exception of prescribing 2mg for Patient O, which did not attract his strong criticism. Dr Deed agreed that if the dose was suddenly dropped, Patient O would experience withdrawal but that does not mean that a GP should continue prescribing at the same dose indefinitely. While Dr Malouf should not have withdrawn Xanax straight away, he should have adopted a multi-disciplinary multi-modal approach.
4. Dr Deed expressed the view that prescribing alprazolam for Patient A is not best practice if one of the reasons is to avoid him buying off the street. The fact that Patient A had been buying Xanax off the street should have alerted Dr Malouf to act strategically and not to collude with him by replacing what he is buying off the street with an equivalent drug. E/Prof Webster said that he does not have a major problem with Dr Malouf prescribing alprazolam when he knows that a previous doctor stopped prescribing and Patient A was buying off the street. Previously, alprazolam was considered an appropriate medication for these symptoms and Dr Malouf was trying to stabilise Patient A and gradually reduce the dosage. Doing so would reduce the risk of this patient buying off the street.
5. For Patient T, Dr Deed's view was the use of concurrent fluoxetine (an anti-depressant) and alprazolam may be appropriate for a presentation of mixed anxiety and depression but there is no clarity of the clinical assessment. This conduct fell significantly below the standard but does not invite his strong criticism. E/Prof Webster said that this was not below the standard.

Conclusion

1. Each patient had a diagnosis of anxiety and/or panic disorder. Alprazolam is indicated for the treatment of such disorders and we are satisfied that Dr Malouf prescribed them for the treatment of those conditions. The fact that they were prescribed for a period of more than two months does not mean that they were prescribed otherwise than for an appropriate therapeutic purpose. The same conclusion applies to prescribing diazepam.
2. For Patient A, the experts appear to have understood that allegation as suggesting that Dr Malouf prescribed alprazolam for the purpose of ensuring that he did not buy Xanax off the street. Even if that was part of Dr Malouf's thinking, he diagnosed Patient A with "anxiety/depression/panic attacks/flashbacks/agoraphobia". The complaint does not challenge that diagnosis. In those circumstances, it cannot be said that Dr Malouf prescribed Patient A alprazolam otherwise than for an appropriate therapeutic purpose.
3. Dr Malouf prescribed paracetamol and codeine to Patient E. There was no evidence that satisfies us that they were prescribed for a non-therapeutic purpose.
4. For Patient S, the HCCC alleged that Dr Malouf prescribed fentanyl in circumstances where it was not prescribed for an appropriate therapeutic purpose. Dr Malouf prescribed fentanyl to Patient S for back pain. He admits that he did not appreciate that fentanyl is an extremely potent narcotic commonly diverted for illicit purposes. As we have said, Dr Malouf acknowledges that when prescribing fentanyl for Patient S, the initial dose was "higher than ideal" and that it was "less than ideal" to prescribe that drug when he knew or should have known that Patient S may have been drug dependent. But it was prescribed for the management of chronic pain. For that reason, it was prescribed for an appropriate therapeutic purpose.
5. Dr Malouf said he prescribed fluoxetine (an anti-depressant) to treat Patient T's depression. That is a therapeutic purpose for prescribing fluoxetine. However, Dr Malouf admitted that he did not understand the risks of prescribing alprazolam with fluoxetine. Neither expert witness identified those risks in any detail. In those circumstances, we are not satisfied that this particular constitutes unsatisfactory professional conduct.
6. None of the particulars relating to not prescribing for an appropriate therapeutic purpose is established.

Summary of the allegations

1. The complaints allege that Dr Malouf prescribed alprazolam without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist. It is also alleged that Dr Malouf did not make appropriate or timely referrals before prescribing diazepam (Patients C, F and I); paracetamol and codeine (Patient E); oxycodone and naloxone (Targin) (Patient H); fentanyl (Patient S) and alprazolam with Fluoxetine (Patient T).

Legal requirements and guidelines

1. If a general practitioner prescribes benzodiazepines long-term to polydrug users, the withdrawal guidelines suggest that another practitioner, preferably a specialist, review those patients periodically for a second opinion. The dependence guidelines at 5.6 acknowledge that long term therapy may be justified for a small number of patients, but that decision needs to be documented and may also involve a second opinion by a specialist. If Dr Malouf had sought an authority to prescribe alprazolam, he would have been asked whether the patient had been reviewed by a psychiatrist in the last 12 months. If so, he would have been asked to attach a recent letter or report supporting alprazolam treatment.

Dr Malouf's response

1. Dr Malouf does not admit this particular for any of the twenty patients. He gave the following reasons for not referring patients to a psychiatrist or other services: it was difficult to find a psychiatrist for a public patient and it could take between 6 - 12 months to get an appointment; similarly it was difficult to get access to other services and they were not resolving the patient's problems; the cost was prohibitive; patients were often unwilling to attend appointments with other professionals or other services; and referral to other services leads to fragmentation in their care.
2. Before February 2016, Dr Malouf did not refer any of his patients to a psychiatrist. For patients A, B, C, D, E, F, G, H, J, K, M, Q, R, S and T Dr Malouf did not think they had psychiatric issues, so he did not refer them to a psychiatrist. After he was told by the PRU in February 2016 that he needed an authority, he attempted to make appointments with psychiatrists.
3. One particular criticism of Dr Malouf is that, even though he was aware of Patient Q's history, particularly his admission to hospital after an overdose, he did not refer Patient Q to mental health or drug and alcohol services. Dr Malouf was aware of "some limited drug misuses" by Patient Q. Again, he interpreted that as being "more in line with his medical need for symptom control". He now accepts that his approach was "less than ideal".

Experts' opinions

1. The question the HCCC asked the experts was: "Did Dr Malouf make appropriate (and timely) referral for specialist assistance when prescribing any of the above drugs to this patient? If not, please specify what referral should have been made."
2. Dr Deed said that GPs should refer patients with comorbid drug dependence and mental health issues to specialist physicians or specialist services. Dr Deed considered Dr Malouf's conduct to fall significantly below the standard and invited his strong criticism, with the exception of prescribing of alprazolam 2mg to Patient O, which did not attract his strong criticism. Patient O had been seen by a psychiatrist who prescribed alprazolam and Dr Malouf continued to prescribe that medication. Dr Deed said he would want to clarify the diagnosis and would refer to another psychiatrist at some stage.
3. For Patient O, E/Prof Webster saw it as Dr Malouf's duty to continue prescribing Xanax, given the history of being on that drug for two years. E/Prof Webster was not critical of Dr Malouf's failure to refer Patient O to another psychiatrist. He said that he had been seeing a psychiatrist for some years and Dr Malouf's main rationale for prescribing alprazolam was that the patient was already dependent.
4. In Dr Deed's view the fact that Dr Malouf did contact psychiatrists after the PRU visit and some were prepared to assess his patients, suggests that services are available and he should have been in touch with them from the outset. Dr Deed acknowledged that he did not know whether services were available in western Sydney, but said if he was practising there, he would find out.
5. E/Prof Webster's view was that Dr Malouf's conduct fell below the standard for Patients A, F, J, L, P and R but not to a significant degree and did not merit strong criticism.
6. E/Prof Webster noted that, in his experience, it is very difficult to refer these patients to addiction specialists or psychiatrists because of the cost and lack of availability. The burden falls on the general practitioner. E/Prof Webster was not critical of Dr Malouf's failure to refer patients to psychologists or psychiatrists because he may have tried to do so in the past and been unsuccessful.
7. In the case of Patients Q and R, the standard was "borderline". E/Prof Webster was not particularly critical of Dr Malouf's treatment of Patient Q. He noted that he could not see anything in the discharge summary from Westmead Hospital about follow up arrangements. He agreed that after receiving that document, indicating that Patient Q was suicidal and on a methadone program, Dr Malouf should have referred Patient Q to a drug and alcohol service. That would have been "appropriate GP practice", although not necessarily "a requirement of good practice". His failure to do so was "borderline standard".
8. Again, E/Prof Webster qualified this opinion with the observation that there is no specific treatment for this cohort of patients and that it is frustrating for GPs when key services are not doing their job. He was not critical of Dr Malouf's failure to refer Patient Q to a psychiatrist because Westmead Hospital had not organised any follow up and he did arrange for him to attend an anger management program. Furthermore, it is difficult to find a psychiatrist who is willing and able to treat this cohort of patients. E/Prof Webster was not overly critical of Dr Malouf's failure to refer, asking rhetorically how many times a GP should try to refer a patient before realising that it is not practical.
9. In relation to Patient Q, Dr Deed said that a GP needs to keep up to date with available services and know their own limits. He would not have prescribed a benzodiazepine for someone on ICE. A GP needs to have enough judgment to know when to refer to other services and not to cause further harm.
10. E/Prof Webster's criticism was the strongest in the case of Patient L. Patient L was admitted to hospital briefly with altered consciousness, presumably due to the effect of drugs. In the Emergency Department, it was noted she was on a methadone program and had recently missed doses. She also reported chronic pain syndrome for which she had been prescribed OxyContin (sustained release oxycodone). Dr Malouf should have followed up with the hospital after receiving the report describing the patient's involvement with methadone and her presentation at the emergency department with apparent drug induced diminished consciousness. E/Prof Webster expressed the view that the conduct described in this particular was significantly below standard and merited strong criticism.
11. E/Prof Webster said that Dr Malouf "struggled to create a referral network because it had not been pre-planned". E/Prof Webster's experience is that access to addiction services is very poor and it is difficult to find psychiatrists to treat patients who are on methadone programs.

Conclusion

1. General practitioners like Dr Malouf, who are not qualified in addiction medicine, should refer patients in this cohort to addiction medicine specialists or work collaboratively with specialist services if those services do not have the capacity to see the patient in person. The experts agreed that it would have been preferable for Dr Malouf to have been supported by a multi-disciplinary team or other specialist services. We agree with them that it is extremely difficult for a GP to manage the problems of drug use disorders without support from other medical professionals. While there are barriers to accessing those services, they were not insurmountable. For example, Dr Malouf managed to make contact with psychiatrists when he was told by the PRU that he needed a psychiatrist's report to apply for an authority to prescribe alprazolam. He wrote letters and made contact with George Street Psychiatric Practice.
2. For the reasons given by the expert witnesses, we are not critical of Dr Malouf's failure to refer Patient O for assessment and advice. For the remaining patients, for the reasons given by Dr Deed, his failure to do so amounts to unsatisfactory professional conduct.
3. We agree with E/Prof Webster and Dr Deed that Dr Malouf's conduct in not referring Patient L to other professional services constitutes professional misconduct. Patient Q is in the same category. Given his mental state and suicide ideation, Dr Malouf should have referred him to other professional services.
4. It is also alleged that Dr Malouf did not make appropriate or timely referrals before prescribing diazepam (Patients C, F and I); Paracetamol and codeine (Patient E); oxycodone and naloxone (Targin) (Patient H); fentanyl (Patient S) and alprazolam with Fluoxetine (Patient T). Neither Dr Malouf, nor the expert witnesses address these particulars in any detail. In circumstances where there is little or no evidence in support of these allegations, they are not proven.
5. In summary, the following complaints constitute unsatisfactory professional conduct: Complaints 1(b), 2(b), 3(b), 4(b), 5(c), 6(c), 7(b), 8(c), 9(b), 10(b), 11(b), 13(b), 14(b), 16(b), 18(b), 19(c) and 20(b). Cumulatively, the following complaints constitute professional misconduct: 12(b) and 17(b).

Summary of allegations

1. Except for Patient M, the HCCC alleged that Dr Malouf prescribed alprazolam in circumstances where the quantity prescribed was excessive according to recognised therapeutic standards. The same allegation was made in relation to diazepam (Patients C and I); oxycodone and naloxone (Patient H) and fentanyl (Patient S).

Legal requirements and guidelines

1. The product information for alprazolam suggests daily dosages which should meet the needs of most patients. Those dosages range from a starting dosage of 0.5 to 1.5 mg daily given in divided doses for anxiety, up to 0.5 to 1.0 mg, given at bedtime, increasing at a rate of 0.25 mg to 1 mg every 3 days until an adequate therapeutic dosage is achieved. The usual dosage range is stated to be 0.5 to 4.0 mg daily given in divided doses for anxiety up to a maximum of 10 mg daily in rare cases of panic related disorders.

Dr Malouf's response

1. Dr Malouf did not admit these particulars for any patient.
2. When he began prescribing alprazolam in 2013, Dr Malouf understood the differences between alprazolam and other benzodiazepines such as diazepam to be marginal. He says he was under the impression that alprazolam was three or four times stronger than diazepam but less sedating and that it was indicated for panic attacks. He now appreciates that it is about ten times stronger. He said he only provided very small quantities which were tightly monitored in the context of extended counselling sessions.
3. Dr Malouf said his practice was to provide a limited supply of medication, usually enough for one or two weeks, but occasionally for a month, with no repeats, unless he was going on holidays. If he was concerned about the quantity, he would note that the pharmacist should dispense weekly, bi-weekly or daily.
4. He told his patients that he would not accept excuses such as lost scripts or lost or stolen medication. However, he conceded that he never refused to provide a script to any of these 20 patients, when they said they had run out but should still have had some tablets left. That happened about ten times, according to Dr Malouf. He thought it was unsafe to withhold the medication because of the risks of withdrawal in abruptly ceasing the medication.
5. For Patient A, Dr Malouf says that the rate of prescribing never escalated, it remained stable. Patient A was on this drug for 6 months, but he was stable. Even though Patient A had been stable for several weeks, Dr Malouf prescribed another 3 weeks supply of alprazolam on 25 November 2015. He did not attempt to lessen the dosage because he still had not resolved the majority of his issues. Dr Malouf would prefer to see 3 to 4 months of stability before starting to wean. Dr Malouf still did not consider Patient A stable enough to decrease the dosage in February 2016 but he did raise the issue with him at that time.
6. When Dr Malouf saw Patient B on 13 January 2015, he had "misplaced" 10 tablets. When Dr Malouf saw him again on 22 February 2015, he prescribed a box of 50 tablets, which should have lasted 33 days. Nineteen days later, he said he had lost 10 tablets (7 days' worth). Dr Malouf gave him another 50 tablets. Dr Malouf conceded that this level of prescribing does not demonstrate tight control because there were 10 or 12 tablets on each visit in May 2015 that were not accounted for. On 26 November 2015, Dr Malouf cautioned Patient B when he unilaterally increased his intake from one per day to 1 ½ per day. Despite that caution, Dr Malouf prescribed 50 tablets, twice as many as on the previous occasion. Dr Malouf said that the increase was "within the bounds" but in retrospect, he should have kept him on the same dosage. He admitted that in this instance he was not demonstrating "tight control".
7. On 13 July 2016, Dr Malouf gave Patient B a private script for 30 tablets of Kalma 2mg. We understand that the significance of writing a private script is that it is not subsidised by the PBS. Dr Malouf's explanation for this was that Patient B was due for his next script on 13 July 2016 but the PBS denied it for 2 weeks because he was slightly ahead on average over the preceding 3 months. According to Dr Malouf, this was the one and only time he ever wrote a private script for one of his patients.
8. For Patient D, Dr Malouf gave him two repeat prescriptions and authorised dispensing the repeat after 20 days, rather than 25 days when the first prescription would have run out. Dr Malouf does not recall exactly why he did this but it may have been to make sure that the patient did not run out of tablets on a weekend.
9. Dr Malouf agreed that he gave Patient E a repeat script for one months' supply of Kalma on 19 November 2015 but cannot recall the reason. He cannot see how this came about because he always indicated in the notes if he gave a repeat script.
10. Dr Malouf initially started Patient F on Valium 5 mg ½-1 tab/day and gave him a script for 10 tablets, but several days later he came back saying they were not helping. Dr Malouf changed him to Kalma 2mg ½- 1 tablet a day on a trial basis and gave him a script for 14 tablets. He increased the dose to two tabs/day "to good effect". There were several days overlap with the two scripts which Dr Malouf did not see as a substantial risk given his poor response to Valium.
11. As Patient G was taking Xanax 2mg 1 ½ tabs per day, off the street, Dr Malouf felt it best to stabilise her on that dose. She was initially given one weeks' supply. Dr Malouf progressively reduced Patient G's intake of Kalma every 2-4 weeks, as circumstances permitted. He says he "had almost fully weaned this patient off alprazolam by the time of the PRU visit on 30 March 2018". This was the only patient in the cohort that he successfully weaned off alprazolam, but Dr Malouf says he was always looking for the possibility of doing so.
12. For Patient H, it was alleged that Dr Malouf's prescribing of oxycodone and naloxone 2.5mg and 1.25mg and/or oxycodone and naloxone 5mg and 2.5mg was excessive according to recognised therapeutic standards. Dr Malouf said that the dose was "the very bottom of the range, reduced to 1 daily at the second visit and remained at that level".
13. In early September 2015, Patient L mentioned that she had left her medication in a bag on the train. Dr Malouf reduced Patient L's alprazolam to a weekly supply following her admission to hospital. He also phoned the hospital pharmacist on 3 September 2015 to clarify the treatment regime. From November 2015 to January 2016, the number of tablets was increased up to 50 tablets per prescription, lasting 3-4 weeks. This was followed by a period where the number of tablets was dropped to 14 per prescription and weekly visits.
14. Patient P was known to the Doctor Shopping Hotline. Despite that, Dr Malouf gave him a month's supply of alprazolam (50 tablets) on 18 July 2013. Dr Malouf agreed that it was not appropriate to prescribe 50 tablets. One or two weeks' supply would have been enough.
15. On 24 February 2015, Dr Malouf received a phone call from police that Patient P was found with OxyContin and his phone contained messages about selling Xanax. Dr Malouf wrote in his notes that Patient P provided an adequate explanation. He recalls that it was "some story of a toothache, which might have been an abscess". When pressed, he says he does not recall the explanation for buying and selling Xanax. He agreed that that information was "concerning". He had some discussions with Patient P about it, but then gave him another script for 50 tablets. He admits that he should have reduced the prescription to a weeks' supply. Dr Malouf thought it was important to give him the benefit of the doubt, having rung the Doctor Shopping Hotline.
16. For Patient S, in relation to the allegation that the prescribing of fentanyl was excessive, Dr Malouf admitted some failings. While he denies giving excessive numbers of patches, he admits that the initiating dosage was "higher than ideal". Dr Malouf highlighted his view that Patient S had safely used fentanyl previously.

Experts' opinion

1. The question the HCCC asked the experts was: "Did Dr Malouf prescribe each of the above drugs to this patient in an appropriate quantity?"
2. Dr Deed does not regard prescribing weekly, fortnightly or monthly with a follow up review as tightly controlling the quantity of alprazolam. In his opinion, that level of prescribing is significantly below the standard and invited his strong criticism. For Patient P, in particular, Dr Deed would not have continued prescribing alprazolam at that dose.
3. E/Prof Webster's assessment was that the conduct fell below the standard for Patients L and P, but did not to a significant degree and did not merit strong criticism. He regarded the quantities Dr Malouf was prescribing as being between mid and high therapeutic levels. His view was that each of the twenty patients presented with features of drug dependence. In those circumstances, the appropriate response is to "continue long-term engagement . . . and over time, try to encourage gradual, very gradual, reduction in dose levels hoping that cessation will eventually be achieved."

Conclusion

1. One risk in prescribing large quantities of alprazolam is that a patient will overdose. Another is that alprazolam will be stolen or sold illegally. Dr Malouf's acceptance of patients' explanations for losing prescriptions was extremely naive. Large quantities of alprazolam entered the community as a result of his prescribing.
2. For this cohort of patients, if alprazolam was to be prescribed, it should have been limited to a brief period and specialist review arranged or an alternative regime established. If a patient is making excuses such as losing tablets, he or she should have been put on daily dispensing. In cases where Dr Malouf was giving monthly prescriptions, or continuing to prescribe weekly or fortnightly where patients were making excuses, that amounts to unsatisfactory professional conduct.
3. For Patient B, D, E, F, L and P Dr Malouf's failure to respond adequately when excuses were given about lost or stolen tablets, amounts to unsatisfactory professional conduct.
4. In summary, the following complaints constitute unsatisfactory professional conduct: Complaints 2(d), 4(d), 5(f), 6(f), 12(d) and 16(d).

Summary of allegations

1. For Patients E, F and S the HCCC alleged that Dr Malouf prescribed alprazolam in circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug. For Patient E, the drug mentioned in the particulars was Panadeine Forte; but Dr Malouf knew that Patient E was buying heroin off the street. For Patient F, the drug was diazepam (which is not a Schedule 8 drug) and for Patient S, the drug was fentanyl. Complaint Eight (Patient H) relates to the prescribing of an opioid (Targin), but there is no particular relating to prescribing alprazolam in combination with Targin.
2. We have considered these allegations for Patients E and S only.

Legal requirements and guidelines

1. The dependence guidelines states that: 4. Avoid prescribing benzodiazepines to patients with comorbid alcohol or substance use disorders or polydrug use. GPs should consider seeking specialist opinion in the management of these patients. Patients who use two or more psychoactive drugs in combination (polydrug use) and those with a history of substance misuse may be more vulnerable to major harms.

Dr Malouf's response

1. In his statement of 3 March 2019, Dr Malouf says that the co-prescribing was said to be with Panadeine Forte (Patient E), and fentanyl (Patient S). Dr Malouf did not discuss with his patients the risks of taking opioids (or alcohol or illegal drugs) with alprazolam because he was not aware of the extent of the risks at that time.
2. For Patient E, Dr Malouf does not admit that it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug. He diagnosed Patient E with anxiety, panic attacks, depression, PTSD and nightmares. He disclosed that he was buying occasional heroin and benzodiazepines off the street. Dr Malouf cannot recall whether he discussed the risks of combining benzodiazepines with heroin but said that the patient would know about those risks.
3. For Patient S, Dr Malouf acknowledges that co-prescribing of alprazolam and an opioid such as fentanyl has some inherent risks and is not ideal. However, it is "cautioned" rather than contra-indicated. He felt that his "tight monitoring and control measures justifiably accommodated a necessary compromise". He now knows that this is not the case and would not do it again.

Experts' opinion

1. The HCCC asked the experts the following question: "Was it appropriate for Dr Malouf to prescribe Sch 8 drugs to this patient without an authority under s 28 of the PTG Act?" There was no separate question asked about prescribing alprazolam in circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug. We have assumed that the experts' answer to the question about prescribing without an authority, also addresses these particulars.
2. E/Prof Webster expressed the view that the main problems with alprazolam are the interactions with other centrally acting agents, notably opioids, and dependence in vulnerable persons.

Conclusion

1. Co-prescribing of benzodiazepines with opioids, is a major risk factor for death by overdose. Co-prescribing alprazolam with panadeine forte is not as serious because panadeine forte is a relatively weak opioid. That conduct amounts to unsatisfactory professional conduct. No particular alleged that Dr Malouf prescribed alprazolam in combination with heroin. Dr Malouf acknowledged that he did not know that fentanyl is an extremely potent narcotic commonly diverted for illicit purposes. We find that particular amounts to professional misconduct.
2. Consequently, we find that the following particulars constitute unsatisfactory professional conduct: Complaint 5 (g). Cumulatively, the following complaint constitutes professional misconduct: Complaint 19(h).

Orders sought

1. We have found the subject matter of various particulars in complaints of unsatisfactory professional conduct to have been proved. We have also found that when various instances of unsatisfactory professional conduct are considered together, they amount to professional misconduct. In those circumstances, suspension or cancellation of Dr Malouf's registration is an option: National Law, s 149C(1)(b).
2. The HCCC submitted that Dr Malouf's registration be cancelled and that he be prevented from applying to be re-registered for two years. In relation to the finding of unsatisfactory professional conduct, the HCCC seeks an order that Dr Malouf be reprimanded. If we impose conditions on his registration, the HCCC has asked to be heard on the terms of any conditions.
3. Dr Malouf submits that even if we find professional misconduct, he should be permitted to continue to practise with the current conditions in relation to prescribing rights. Dr Malouf submitted that any lack of knowledge or judgment can be addressed by continuing the existing condition on his registration.

Principles for making protective orders

1. The objective and guiding principle when exercising functions under the National Law is that "the protection of the health and safety of the public" is "the paramount consideration": National Law, s 3A. In Health Care Complaints Commission v Dr Della Bruna [2014] NSWCATOD 31 Wright J at [88] summarised that principle and four other principles underlying the purpose of orders made under Part 8, Division 3, Sub Division 6. (1) In the exercise of its functions under Subdivision 6 of Division 3 of Part 8 of the National Law, the protection of the health and safety of the public must be the Tribunal's paramount consideration - s 3A of the National Law. (2) Disciplinary proceedings against members of a profession are intended to maintain proper ethical and professional standards, primarily for the protection of the public but also for the protection of the profession - Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 at 637. (3) The public interests served by protective orders include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (4) Protective orders also involve an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (5) Although the specific purpose for which the Tribunal makes orders is protective of the public interest and not punitive with respect to the practitioner, that is not to deny that such orders may be punitive in effect and that punitive effect may be relevant in formulating a protective order - Lee v Health Care Complaints Commission [2012] NSWCA 80 at [20] citing Director General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83].
2. Shortly after the Appeal Panel summarised these principles, the Court of Appeal held in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35], that protecting the health and safety of the public "includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession."
3. Dr Malouf's counsel provided a table summarising eighteen other so-called "prescribing" cases decided between 2010 and 2016. The HCCC also referred to some more recent cases. Dr Malouf's counsel submitted that this case is different from every other prescribing case that has come before the Tribunal. In Lee v Health Care Complaints Commission [2012] NSWCA 80 at [34] the Court of Appeal summarised the approach the Tribunal should take to comparable decisions: (a) comparison with the outcomes in earlier cases may be useful if those earlier cases show some discernible range or pattern; (b) such a range or pattern, even when discernible, cannot be regarded as a precedent indicating what is "correct"; (c) the range or pattern is, at best, a reflection of the accumulated experience and wisdom of decision-makers; (d) the range or pattern will potentially be of value only if it is possible to gather from it an appreciation of some unifying principle; (e) since the predominant consideration is the protection of the public, a decision can only be made by reference to the facts of the particular case and by considering what measures are needed to ensure that the future behaviour of the particular practitioner is shaped in a way that is consistent with that protection; and (f) the Medical Tribunal, as a specialist tribunal, brings special skill and experience to the task of formulating protective orders.
4. In our view, the comparable decisions do not show any discernible range or pattern in relation to prescribing cases. We have focused on the facts of this particular case and the need to ensure both that the public is protected and that public confidence in the standards of the profession is upheld.

Seriousness of the conduct

1. Dr Malouf did not obtain the required authority to prescribe alprazolam and other medication to drug dependent patients. An authority is required because of the risks of overdose and overdose deaths especially when benzodiazepines are taken in combination with opioids. There was no statistical evidence as to the incidence of overdose and overdose deaths, but the dependence guidelines state that when benzodiazepines are combined with opioids, including methadone, "patients are at risk of respiratory depression, heavy sedation, coma and death".
2. Dr Malouf did not undertake a comprehensive medical assessment or give thoughtful consideration to the likely risks and benefits of the medications he prescribed. He was ignorant of or underestimated the risks of potential dependence, overdose, and diversion of benzodiazepines. At the time, he justified his conduct, at least to some extent, by the need to stabilise patients because of the risk of major withdrawal. While that risk needs to be taken into account when exercising clinical judgement, it is not the only factor. Dr Malouf failed to identify substance use disorders, or if he did identify those disorders, he did little or nothing to minimise the potential harms associated with prescription drug misuse.
3. We acknowledge the practical difficulties in managing this cohort of drug addicted patients. But those difficulties do not excuse Dr Malouf's ignorance and failure to attempt to refer patients for assessment and advice by other health providers.

Prior disciplinary action

1. Dr Malouf voluntarily relinquished his prescribing rights for Schedule 8 and Schedule 4, appendix D drugs on 30 March 2016. He signed the following conditions in relation to prescribing rights on 5 May 2016: 3. Not to possess, supply, administer or prescribe any "drug of addiction" (Schedule 8 drug) as defined by the Poisons and Therapeutic Goods Act 1966 (NSW) and any substance listed in Schedule 4 appendix D to the Poisons and Therapeutic Goods Regulation 2008 (NSW), except to prescribe on a medication chart/medical record for any patient who is under his immediate care at any residential aged care facility.
2. Consequently, with very limited exceptions, Dr Malouf has not prescribed drugs including alprazolam, diazepam or fentanyl, for more than 3 years.

Dr Malouf's character

1. Doctors Miles Burkitt, Anthony Joseph and Chris Grant; barristers Giles Tabuteau and Anthony O'Brien; and Registered Nurse Zeina Ormond all provided character references. They were unanimous in their opinion of his good character and their confidence that he will not repeat the errors he has made. We find that Dr Malouf had good intentions and that he did not act dishonestly. Nevertheless, his justification for prescribing alprazolam, including to stabilise those patients and prevent the effects of sudden withdrawal, was ill informed and counterproductive.

Level of insight

1. Counsel for the HCCC submitted that Dr Malouf lacks insight because he did not admit that any of his conduct constitutes unsatisfactory professional conduct. Instead he characterised his conduct as including some "failings" and "imperfections". For other instances, he described his conduct as "less than ideal". Given the disparity between the opinions of the experts as to the seriousness of his conduct, he said he preferred to leave it to the Tribunal to make the decision.
2. Dr Malouf asserted that he now has an increased knowledge and awareness of the dangers of alprazolam, especially when taken with an opioid and the potential for their abuse. He now knows that alprazolam is more potent than diazepam and has a shorter half-life. He says he now appreciates that these medications have a very limited role and should invariably be prescribed for short-term use. He says he understands more fully the risks of alprazolam being tampered with or on-sold into the illicit drug market. He acknowledges that he should have pressed "harder and earlier" to establish whether a patient was on an OTP and handed over the prescribing of benzodiazepines to the methadone prescriber.
3. During the hearing, Dr Malouf reiterated what he had learnt from this experience. In summary he said he has learnt that: he needs an authority to prescribe alprazolam, he should check with NSW Health websites and keep himself up to date; he should know the pharmacology of alprazolam and how it differs from other benzodiazepines; he should be careful when prescribing alprazolam with opioids; he should press harder to find out whether a patient is on an OTP; he should liaise with OTP prescribers; he should prescribe diazepam in preference to alprazolam and wean patients to a lower dose; he should engage with psychiatrists, psychologists and drug and alcohol services; he should obtain a more detailed medical history; he should not prescribe benzodiazepines for more than 6 weeks for most patients; he should conduct a more comprehensive physical examination and be more open to using the DSM to confirm a diagnosis.

Conclusion

1. The power to prescribe drugs of addiction and restricted substances is subject to strict legislative requirements which were not adhered to in this case. Dr Malouf failed to comply with those requirements, and with other standards, for more than two years. His conduct directly affected at least 20 patients. Dr Malouf's conduct, while well intentioned, put his patients at risk of prolonged drug dependence, overdose and suicide.
2. Dr Malouf has demonstrated that he now knows, in theory, how he should have treated his patients. But he came to the hearing without a sufficient appreciation of the seriousness of his conduct and the potential risks involved. He persisted in denying that his knowledge, skill or judgment, in any respect, was significantly below the standard reasonably expected of a practitioner of his level of training or experience. Even E/Prof Webster disagreed with that characterisation for two particulars. We are not confident given Dr Malouf's stance, that he fully appreciates the magnitude of his prescribing transgressions and the potential adverse consequences of his behaviour. His lack of insight suggests that he may continue believing that he can effectively treat patients himself, with minimal external support.
3. In order to protect the public from similar misconduct and to uphold public confidence in the standards of the profession, we consider that a short period of suspension (6 months) is justified. In addition, Dr Malouf should be reprimanded.
4. When he returns to practice, Dr Malouf should continue to be subject to the current condition that he not prescribe certain drugs of addiction. Other conditions relating to mentoring or further education may be appropriate. We have made directions for the parties to provide any further submissions as to additional conditions. The conditions may be altered, varied or removed at the discretion of the Medical Council of New South Wales and the Council is the appropriate review body for the purposes of Div 8 of Pt 8 of the Health Practitioner Regulation National Law (NSW).

Protective Orders 1. Dr Malouf is reprimanded. 2. Dr Malouf's registration as a medical practitioner is suspended for 6 months from the date of publication of this decision. 3. When the period of suspension has expired, Dr Malouf is to be subject to the following condition: Not to possess, supply, administer or prescribe any "drug of addiction" (Schedule 8 drug) as defined by the Poisons and Therapeutic Goods Act 1966 (NSW) and any substance listed in Schedule 4 appendix D to the Poisons and Therapeutic Goods Regulation 2008 (NSW), except to prescribe on a medication chart/medical record for any patient who is under his immediate care at any residential aged care facility. 1. The Health Care Complaints Commission is to file and serve any submissions as to additional conditions that it says should be imposed 28 days from the date of this decision, together with submissions as to whether that issue can be determined without a hearing. 2. Dr Malouf is to file and serve any submissions in response to the Health Care Complaints Commission's submissions within a further 28 days together with submissions as to whether that issue can be determined without a hearing. 3. The Medical Council is the appropriate review body for the purposes of Division 8 of Part 8 of the Health Practitioner Regulation National Law (NSW). 4. If Dr Malouf ceases to reside in New South Wales, the conditions are to be reviewed in accordance with ss 125 to 127 of the Health Practitioner Regulation National Law (NSW).

Costs

1. The HCCC seeks an order that Dr Malouf pay its costs. The Tribunal has power to order that one party should pay another party's costs: National Law, Sch 5D, cl 13. That provision states that: 13 Tribunal may award costs [NSW] (1) The Tribunal may order the complainant (if any), the registered health practitioner or student concerned, or any other person entitled to appear (whether as of right or because leave to appear has been granted) at an inquiry or appeal before the Tribunal to pay costs to another person as decided by the Tribunal. (2) When an order for costs has taken effect, the Tribunal is, on application by the person to whom the costs have been awarded, to issue a certificate setting out the terms of the order and stating that the order has taken effect. (3) The person in whose favour costs are awarded may file the certificate in the District Court, together with an affidavit by the person as to the amount of the costs unpaid, and the Registrar of the District Court must enter judgment for the amount unpaid together with any fees paid for filing the certificate. (3A) The Tribunal may fix the amount of costs itself or order that the amount of costs be assessed by a costs assessor under the legal costs legislation (as defined in section 3A of the Legal Profession Uniform Law Application Act 2014) or on any other basis. (4) This clause applies instead of section 60 (Costs) of the Civil and Administrative Tribunal Act 2013.
2. The general rule is that the unsuccessful party should be ordered to pay the successful party's costs. In legal terms, that principle is expressed as costs following the event: Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Meagher JA, Emmett JA and Beech-Jones J at [42].
3. The presumption that a successful party is entitled to costs is generally only displaced where there has been some "disentitling conduct" by the successful party: Oshlack v Richmond River Council [1998] HCA 11; 193 CLR 72 at [40]. The Health Care Complaints Commission was largely successful in these proceedings and there was no disentitling conduct.
4. Dr Malouf is to pay the Health Care Complaints Commission's costs as agreed. If agreement is not reached, costs are to be assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

Appendix A IN THE CIVIL AND ADMINISTRATIVE TRIBUNAL OF NEW SOUTH WALES OCCUPATIONAL DIVISION HEALTH PRACTITIONER DIVISION LIST NO. Of In the matter of Dr. George Tewfic Malouf, a person registered under the Health Practitioner Regulation National Law (NSW) The Health Care Complaints Commission of Level 13, 323 Castlereagh Street, Sydney NSW, having consulted with the Medical Council of New South Wales in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law") HEREBY COMPLAINS THAT Dr George Tewfic Malouf ("the practitioner") c/- Avant Law, Darling Park Tower 3, Level 6, 201 Sussex Street, SYDNEY NSW 2000 being a medical practitioner registered under the National Law, COMPLAINT ONE is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT ONE At all relevant times Dr Malouf was a registered general practitioner practising at the Malouf Family Medical Practice in Parramatta in the State of New South Wales. The re-scheduling of the drug Alprazolam to a Schedule 8 "drug of addiction" as defined by the Poisons and Therapeutic Goods Act 1966 (NSW) ("PTGA") took effect on 1 February 2014. PARTICULARS OF COMPLAINT ONE

1. The practitioner failed to provide appropriate care and treatment for Patient A in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule A: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient A was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA. COMPLAINT TWO is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT TWO As for Complaint One. PARTICULARS OF COMPLAINT TWO
2. The practitioner failed to provide appropriate care and treatment for Patient B in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule B: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient B was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA. COMPLAINT THREE is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT THREE As for Complaint One. PARTICULARS OF COMPLAINT THREE
3. The practitioner failed to provide appropriate care and treatment for Patient C in that he prescribed Alprazolam 2mg and Diazepam 5mg for the patient on the dates and in the quantities as set out in Schedule C: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where Alprazolam was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where Diazepam was not prescribed for an appropriate therapeutic purpose; (e) In circumstances where the quantity of Alprazolam prescribed was excessive according to recognised therapeutic standards; (f) In circumstances where the quantity of Diazepam prescribed was excessive according to recognised therapeutic standards; (g) In circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug; (h) In circumstances where Patient C was enrolled on the NSW Opioid Treatment Program ("OTP"); (i) In circumstances where the practitioner did not have an authority under section 29 of the PTGA to prescribe Alprazolam, contrary to the requirements of section 28 of the PTGA. COMPLAINT FOUR is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT FOUR As for Complaint One. PARTICULARS OF COMPLAINT FOUR
4. The practitioner failed to provide appropriate care and treatment for Patient D in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule D: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient D was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA. COMPLAINT FIVE is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT FIVE As for Complaint One. PARTICULARS OF COMPLAINT FIVE
5. The practitioner failed to provide appropriate care and treatment for Patient E in that he prescribed Alprazolam 2mg and Paracetamol and Codeine 500mg + 30mg for the patient on the dates and in the quantities as set out in Schedule E: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without conducting an appropriate assessment prior to prescribing Paracetamol and Codeine 500mg + 30mg; (c) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (d) In circumstances where Alprazolam was not prescribed for an appropriate therapeutic purpose; (e) In circumstances where Paracetamol and Codeine 500mg + 30mg was not prescribed for an appropriate therapeutic purpose; (f) In circumstances where the quantity of Alprazolam prescribed was excessive according to recognised therapeutic standards; (g) In circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug; (h) In circumstances where Patient E was enrolled on the NSW Opioid Treatment Program ("OTP"); (i) In circumstances where the practitioner did not have an authority under section 29 of the PTGA to prescribe either Alprazolam or Codeine, contrary to the requirements of section 28 of the PTGA; (j) In circumstances where he knew or ought to have been aware that Patient E may have had a drug dependency. COMPLAINT SIX is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT SIX As for Complaint One. PARTICULARS OF COMPLAINT SIX
6. The practitioner failed to provide appropriate care and treatment for Patient F in that he prescribed Alprazolam 2mg and Diazepam 5mg for the patient on the dates and in the quantities as set out in Schedule F: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without conducting an appropriate assessment prior to prescribing Diazepam; (c) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (d) In circumstances where Alprazolam was not prescribed for an appropriate therapeutic purpose; (e) In circumstances where Diazepam was not prescribed for an appropriate therapeutic purpose; (f) In circumstances where the quantity of Alprazolam prescribed was excessive according to recognised therapeutic standards; (g) In circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug; (h) In circumstances where Patient F was enrolled on the NSW Opioid Treatment Program ("OTP"); (i) In circumstances where the practitioner did not have an authority under section 29 of the PTGA to prescribe Alprazolam, contrary to the requirements of section 28 of the PTGA. COMPLAINT SEVEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT SEVEN As for Complaint One. PARTICULARS OF COMPLAINT SEVEN
7. The practitioner failed to provide appropriate care and treatment for Patient G in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule G: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient G was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient G may have had a drug dependency. COMPLAINT EIGHT is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT EIGHT As for Complaint One. PARTICULARS OF COMPLAINT EIGHT
8. The practitioner failed to provide appropriate care and treatment for Patient H in that he prescribed Alprazolam 2mg, Oxycodone + naloxone 2.5mg + 1.25mg and Oxycodone + naloxone 5mg + 2.5mg for the patient on the dates and in the quantities as set out in Schedule H: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without conducting an appropriate assessment prior to prescribing Oxycodone + naloxone 2.5mg + 1.25mg and/or Oxycodone + naloxone 5mg + 2.5mg; (c) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (d) In circumstances where Alprazolam was not prescribed for an appropriate therapeutic purpose; (e) In circumstances where Oxycodone + naloxone 2.5mg + 1.25mg and/or Oxycodone + naloxone 5mg + 2.5mg was not prescribed for an appropriate therapeutic purpose; (f) In circumstances where the quantity of Alprazolam prescribed was excessive according to recognised therapeutic standards; (g) In circumstances where the quantity of Oxycodone + naloxone 2.5mg + 1.25mg and/or Oxycodone + naloxone 5mg + 2.5mg prescribed was excessive according to recognised therapeutic standards; (h) In circumstances where Patient H was enrolled on the NSW Opioid Treatment Program ("OTP"); (i) In circumstances where the practitioner did not have an authority under section 29 of the PTGA to prescribe either Alprazolam or Oxycodone, contrary to the requirements of section 28 of the PTGA; (j) In circumstances where he knew or ought to have been aware that Patient H may have had a drug dependency. COMPLAINT NINE is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT NINE As for Complaint One. PARTICULARS OF COMPLAINT NINE
9. The practitioner failed to provide appropriate care and treatment for Patient I in that he prescribed Diazepam 5mg for the patient on the dates and in the quantities as set out in Schedule I: (a) Without conducting an appropriate assessment prior to prescribing Diazepam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient I was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA. COMPLAINT TEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT TEN As for Complaint One. PARTICULARS OF COMPLAINT TEN
10. The practitioner failed to provide appropriate care and treatment for Patient J in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule J: (a) Without conducting an appropriate assessment and advice prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient J was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient J may have had a drug dependency. COMPLAINT ELEVEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT ELEVEN As for Complaint One. PARTICULARS OF COMPLAINT ELEVEN
11. The practitioner failed to provide appropriate care and treatment for Patient K in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule K: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient K was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient K may have had a drug dependency. COMPLAINT TWELVE is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT TWELVE As for Complaint One. PARTICULARS OF COMPLAINT TWELVE
12. The practitioner failed to provide appropriate care and treatment for Patient L in that he prescribed Alprazolam for the patient on the dates and in the quantities as set out in Schedule L: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient L was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient L may have had a drug dependency. COMPLAINT THIRTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT THIRTEEN As for Complaint One. PARTICULARS OF COMPLAINT THIRTEEN
13. The practitioner failed to provide appropriate care and treatment for Patient M in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule M: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where Patient M was enrolled on the NSW Opioid Treatment Program ("OTP"); (e) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (f) In circumstances where he knew or ought to have been aware that Patient M may have had a drug dependency. COMPLAINT FOURTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT FOURTEEN As for Complaint One. PARTICULARS OF COMPLAINT FOURTEEN
14. The practitioner failed to provide appropriate care and treatment for Patient N in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule N: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient N was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient N may have had a drug dependency. COMPLAINT FIFTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT FIFTEEN As for Complaint One. PARTICULARS OF COMPLAINT FIFTEEN
15. The practitioner failed to provide appropriate care and treatment for Patient O in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule O: (a) Without conducting an appropriate assessment on 20 November 2013 when continuing to prescribe Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient O was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient O may have had a drug dependency. COMPLAINT SIXTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT SIXTEEN As for Complaint One. PARTICULARS OF COMPLAINT SIXTEEN
16. The practitioner failed to provide appropriate care and treatment for Patient P in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule P: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient P was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient P may have had a drug dependency. COMPLAINT SEVENTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT SEVENTEEN As for Complaint One. PARTICULARS OF COMPLAINT SEVENTEEN
17. The practitioner failed to provide appropriate care and treatment for Patient Q in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule Q: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient Q was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient Q may have had a drug dependency. COMPLAINT EIGHTEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT EIGHTEEN As for Complaint One. PARTICULARS OF COMPLAINT EIGHTEEN
18. The practitioner failed to provide appropriate care and treatment for Patient R in that he prescribed Alprazolam 2mg for the patient on the dates and in the quantities as set out in Schedule R: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient R was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient R may have had a drug dependency. COMPLAINT NINETEEN is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT NINETEEN As for Complaint One. PARTICULARS OF COMPLAINT NINETEEN
19. The practitioner failed to provide appropriate care and treatment for Patient S in that he prescribed Alprazolam 2mg, Fentanyl 12mcg/hr, Fentanyl 25mcg/hr, Mirtazapine 30mg and Mirtazapine 45mg for the patient on the dates and in the quantities as set out in Schedule S: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam with Mirtazapine; (b) Without conducting an appropriate assessment prior to prescribing Fentanyl; (c) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (d) In circumstances where Alprazolam was not prescribed for an appropriate therapeutic purpose; (e) In circumstances where Fentanyl was not prescribed for an appropriate therapeutic purpose; (f) In circumstances where the quantity of Alprazolam prescribed was excessive according to recognised therapeutic standards; (g) In circumstances where the quantity of Fentanyl prescribed was excessive according to recognised therapeutic standards; (h) In circumstances where it was inappropriate to prescribe benzodiazepines in combination with a Schedule 8 drug; (i) In circumstances where Patient S was enrolled on the NSW Opioid Treatment Program ("OTP"); (j) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (k) In circumstances where he knew or ought to have been aware that Patient S may have had a drug dependency. COMPLAINT TWENTY is guilty of unsatisfactory professional conduct under section 139B of the National Law in that the practitioner has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. BACKGROUND TO COMPLAINT TWENTY As for Complaint One. PARTICULARS OF COMPLAINT TWENTY
20. The practitioner failed to provide appropriate care and treatment for Patient T in that he prescribed Alprazolam 2mg and Fluoxetine 20mg for the patient on the dates and in the quantities as set out in Schedule T: (a) Without conducting an appropriate assessment prior to prescribing Alprazolam with Fluoxetine; (b) Without making appropriate or timely referrals for assessment and advice by a specialist or allied health provider, including a psychologist or psychiatrist; (c) In circumstances where it was not prescribed for an appropriate therapeutic purpose; (d) In circumstances where the quantity prescribed was excessive according to recognised therapeutic standards; (e) In circumstances where Patient T was enrolled on the NSW Opioid Treatment Program ("OTP"); (f) In circumstances where the practitioner did not have an authority under section 29 of the PTGA, contrary to the requirements of section 28 of the PTGA; (g) In circumstances where he knew or ought to have been aware that Patient T may have had a drug dependency. COMPLAINT TWENTY-ONE is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, or ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration BACKGROUND TO COMPLAINT TWENTY-ONE As for Complaint One. PARTICULARS OF COMPLAINT TWENTY-ONE
21. The following the particulars are relied upon individually: (a) Complaint One, particulars 1(a), (b), (c), (d), (e) and (f); (b) Complaint Two, particulars 1 (a), (b), (c), (d), (e) and (f); (c) Complaint Three, particulars 1 (a), (b), (c), (d), (g), (h) and (i); (d) Complaint Four, particulars 1 (a), (b), (c), (d), (e) and (f); (e) Complaint Five, particulars 1 (a), (b), (c), (d), (e), (f), (g), (h), (i) and 0); (f) Complaint Six, particulars 1 (a), (c), (d), (e), (f), (g), (h) and (i); (g) Complaint Seven, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (h) Complaint Eight, particulars 1 (a), (b), (c), (d), (e), (f), (g), (h), (i) and (j); (i) Complaint Nine, particulars 1 (a), (b), (c), (d), (e) and (f); (j) Complaint Ten, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (k) Complaint Eleven, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (I) Complaint Twelve, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (m) Complaint Thirteen, particulars 1 (a), (b), (c), (d) and (e); (n) Complaint Fourteen, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (o) Complaint Fifteen, particulars 1 (a), (d), (e) and (f); (p) Complaint Sixteen, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (q) Complaint Seventeen, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (r) Complaint Eighteen, particulars 1 (a), (b), (c), (d), (e), (f) and (g); (s) Complaint Nineteen, particulars 1 (a), (b), (c), (d), (e), (f), (g), (h), (i), (j) and (k); (t) Complaint Twenty, particulars 1 (a), (b), (c), (d), (e), (f) and (g).
22. Complaints One to Twenty and the particulars thereof are relied upon cumulatively or in any combination. Dated 11 October 2018 Karen Mobbs Director of Proceedings Health Care Complaints Commission 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: 25 October 2019