Williams v A Professional Conduct Committee
[2018] NZHC 2472
•20 September 2018
IN THE HIGH COURT OF NEW ZEALAND AUCKLAND REGISTRY
I TE KŌTI MATUA O AOTEAROA TĀMAKI MAKAURAU ROHE
CIV-2017-404-002113
[2018] NZHC 2472
IN THE MATTER OF an appeal pursuant to s 106(2) of the Health Practitioners Competence Assurance Act 2003 BETWEEN
JOSEPH WILLIAMS
Appellant
AND
A PROFESSIONAL CONDUCT
COMMITTEE OF THE MEDICAL COUNCIL
Respondent
Hearing: 21 August 2018 Appearances:
A H Waalkens QC and A Holloway for Appellant A K Miller and B Johns for Respondent
Judgment:
20 September 2018
JUDGMENT OF WYLIE J
This judgment was delivered by Justice Wylie On 20 September 2018 at 4.00 pm
Pursuant to r 11.5 of the High Court Rules Registrar/Deputy Registrar
Date:…………………………
Solicitors/counsel:
DLA Piper/A H Waalkens QC, Auckland Claro, Wellington
WILLIAMS v A PROFESSIONAL CONDUCT COMMITTEE OF THE MEDICAL COUNCIL [2018] NZHC
2472 [20 September 2018]
Introduction
[1] The appellant, Dr Williams, appeals against a decision of the Health Practitioners Disciplinary Tribunal (the Tribunal) dated 1 September 2017, which found him guilty of two charges of professional misconduct, censured him, fined him
$10,000, imposed conditions on his continued practice and ordered him to pay
$145,000 in costs.1
[2] Dr Williams appeals the Tribunal’s finding of professional misconduct and seeks to quash that determination. In the alternative, he appeals that part of the decision which imposed the $10,000 fine and seeks to quash that fine.
[3] The respondent, the Professional Conduct Committee (the PCC), opposes the appeal and argues that the Tribunal’s decision was correct.
Factual background
[4] Dr Williams is a general practitioner – based in Auckland. He has some 38 years’ experience in that capacity. Over the years, he has developed a specialist interest in the treatment and management of patients with eczema. He published a book on the topic in February 2014 which has sold nearly 3,000 copies.
[5] Eczema is a chronic inflammatory disease affecting about 30 per cent of New Zealand children. It appears before the age of five years in approximately 90 per cent of those who suffer from it; 60 per cent of sufferers experience it before turning one year old. The disease is distressing for those affected and it imposes considerable costs on the health system. Its treatment is complex and multifaceted, but it is commonly accepted that a core component of therapy is to manage the inflammation with topical corticosteroids.
[6] In about 1963, Dr Williams and a chemist developed what Dr Williams believes is an effective treatment for eczema. It is a compound (or mix) of two creams. One cream is a topical corticosteroid (betamethasone valerate 0.1%) and the other is an anti-fungal cream (clomazol 1%). They are mixed together in one of three different
1 Professional Conduct Committee v Williams HPDT 909/Med16/371P, 1 September 2017.
strengths or ratios. Dr Williams calls this compound product “betaclom”. He claims to have successfully used betaclom for some years; indeed, he estimates that some 47,300 patients have been treated with betaclom, all without complaint or issue. He says that many of those patients specifically sought him out because they had become dissatisfied with the care they were receiving from others and because they were looking for a change in their treatment regimes.
[7] In recent years, other medical professionals have become concerned about Dr Williams’ use of steroids to treat skin conditions and various complaints have been made to Dr Williams or to the appropriate medical authorities. Complaints from fellow medical practitioners started in August 2011 and they have been made intermittently since.2
[8] In June 2014, the Medical Council of New Zealand issued a notice of risk of harm under s 35 of the Health Practitioners Competence Assurance Act 2003 (the Act) relating to Dr Williams prescribing betaclom for use on children.
[9] Dr Williams’ conduct in prescribing betaclom to various patients was referred to the PCC for investigation and, on 29 September 2016, it laid a disciplinary charge before the Tribunal alleging that Dr Williams had acted in a manner amounting to professional misconduct under either s 100(1)(a) and/or (b) of the Act. The charge was amended and an additional charge was laid in May 2017. An anonymised copy of the charges is annexed to this decision. They came before the Tribunal for hearing over eight days in July/August 2017.
Two decisions
[10] The Tribunal has issued two decisions – both covering much the same ground. First, it issued an oral decision on the last day of the hearing – 10 August 2017. That decision was later transcribed. It runs to some 15 pages. It is more than a “results judgment”. The Tribunal then issued another more fulsome decision in writing on 1 September 2017.3
2 Details of the complaints alleged by the PCC are in the schedules forming part of the charges which are annexed to this judgment.
3 Professional Conduct Committee v Williams, above n 1.
[11] This procedure strikes me as unusual and fraught with risk. Fortunately, it is not suggested in this case that there is any material conflict between the two decisions. The parties’ submissions before me largely focussed on the 1 September 2017 decision and, unless expressly noted, this judgment refers to that decision.
The Tribunal’s decision of 1 September 2017
[12] The Tribunal summarised the relevant factual background, noting, inter alia, Dr Williams’ special interest in the treatment of eczema. It observed that he is a general practitioner and that his conduct fell to be judged accordingly. It referred to Dr Williams’ practice of combining betamethasone valerate and clomazol and providing this compound to his patients for use by them. It noted that, at consultation, Dr Williams described how the betaclom should be applied and handed a guide sheet entitled “ECZEMA CARE – MANAGEMENT GUIDE SHEET” to his patients or to their parents. The guide sheet included the following advice:
YOUR CREAM – this is our low dose steroid/anti-fungus eczema cream
– (It is not a moisturiser)
Apply twice daily to affected areas.
On the reverse side, there was a flowchart detailing the application process, which included the following:
Apply Beta/clom cream 2 x daily on affected eczema skin only – (not on normal skin)
Apply enough cream – not sparingly For eczema skin
[13] The Tribunal then considered the charges and the relevant legal tests it was required to apply. It noted that the onus of proving the charges lay on the PCC, on the balance of probabilities, and that the more serious the allegation, the higher the level of proof required.
[14] The Tribunal then considered the nature of betamethasone valerate, referring to the evidence presented to it. It observed that betamethasone valerate is an active topical corticosteroid, but it did not make any express finding as to its potency. It then considered clomazol. Inter alia, it was alleged by the PCC that Dr Williams had prescribed clomazol in circumstances where the prescription was not clinically justified. The Tribunal noted that this particular of the charge (repeated in respect of a number of patients) was not pressed by the PCC, other than in the context of clomazol having been mixed with betamethasone valerate to produce betaclom. The Tribunal found there was “not significant evidence to support the separate allegations in relation to the prescription of clomazol”, and that this particular was not made out.4
[15] The Tribunal then went on to consider the potency of betaclom, noting Dr Williams’ evidence and the evidence of other witnesses. The Tribunal concluded that mixing betamethasone valerate with clomazol did not dilute the potency of the betamethasone valerate, observing instead that mixing might increase its potency.5 The Tribunal found that the steroid effect of the betaclom prescribed by Dr Williams was no less potent than the steroid effect of the betamethasone valerate component in the betaclom.6
[16] The Tribunal then dealt with a defence advanced by Dr Williams under s 100(4) of the Act, namely that he should not be found guilty of a disciplinary offence because he had adopted and practiced a theory of medicine and, in doing so, had acted honestly and in good faith. The Tribunal found that Dr Williams had not adopted and practiced a theory of medicine, taking the view that betaclom was nothing more than a mixture of two other medicines, each of which had its own function and appropriate use.7 It accepted that the medicines can be and are used from time to time in combination, but it observed that, if Dr Williams’ theory of medicine was that the potency of the betamethasone valerate was diluted by the addition of clomazol, this theory did not escape “the inevitable fact that the combination was still in the significantly potent category”.8 It considered that any honest belief of, or acting in good faith by,
4 At [28].
5 At [39].
6 At [42].
7 At [47]-[48].
8 At [49].
Dr Williams in this regard did not create a new theory of medicine.9 The Tribunal did not accept that the defence available under s 100(4) of the Act was open to Dr Williams.10
[17] The Tribunal then considered Dr Williams’ use of betaclom despite what were said to be repeated concerns raised by others. It reviewed the various expressions of concern. It noted the submissions made for Dr Williams, including that it was unfair to suggest that he had ignored the concerns expressed, that he felt he had been “got at” by fellow practitioners, his view that his patients had made good progress using betaclom and his assertion there was no evidence of harm to them. It recorded that Dr Williams genuinely believed that betaclom is effective. The Tribunal nevertheless concluded that the concerns raised should have:11
(a)caused Dr Williams to carefully assess his position and undertake further enquiry;
(b)at the least, caused Dr Williams to discuss with the specialist dermatologist(s) or paediatric dermatologist(s) concerned the cases of those patients who he knew or ought to have known were under specialist care, to determine whether his continued prescribing for those patients of a potent topical corticosteroid was appropriate; and
(c)caused Dr Williams to have researched the matter further.
The Tribunal considered that, instead, Dr Williams continued to prescribe betamethasone valerate and clomazol to the relevant patients mixed together as betaclom. The Tribunal accepted that the betaclom mixture had been effective, observing that this was because of the significant potency of the topical corticosteroid in it. The Tribunal considered that, for this reason, betaclom was bound to work in the short-term, but the concern was with the quantities and the potency of the medicine prescribed by Dr Williams. The Tribunal considered that both were “way in excess of what was needed, especially when [the patients] were young infants or children”, or
9 At [49].
10 At [51].
11 At [60].
where there were “contraindications”.12 The Tribunal concluded that Dr Williams’ conduct in prescribing betaclom to the individual patients detailed in the charges, in the circumstances of each, was misconduct as being either malpractice or negligence and as bringing discredit to the medical profession.13
[18] The Tribunal then turned to the allegations in relation to Dr Williams’ documenting of patient records. It viewed Dr Williams’ records and considered that they were inadequate and did not meet appropriate standards (including those set out in the Medical Council’s publication – The Maintenance and Retention of Patient Records) which require clear and accurate reporting of relevant clinical findings, decisions made, information given to patients and any drugs or other treatment prescribed.14
[19] The Tribunal then turned to consider whether disciplinary sanction was warranted. It noted the purpose of such sanction – to maintain standards in the profession and to protect the public. It took the view that some of the matters referred to in the particulars of the charges did warrant disciplinary sanction on their own account and that others did so on a cumulative basis. It considered that disciplinary sanction was required both to maintain standards in the profession and to protect the public.15 It took the view that it needed to send a clear message to the medical profession – namely that the excessive prescription of potent topical corticosteroids such as betamethasone valerate and any combination of a potent topical corticosteroid with another drug such as clomazol, where there have been no adequate trials and approval, is not acceptable.
[20] The Tribunal then went on to consider in detail the individual patients’ cases set out in the charges, indicating which particulars it considered warranted disciplinary sanction, either individually, or cumulatively with other particulars relating to the same patient, or in combination with other particulars in relation to the other patients. Some of the particulars in relation to some patients were found not to have been proved.
12 At [61].
13 At [63].
14 At [65]-[66].
15 At [77].
[21]Finally, the Tribunal summarised its findings and went on to deal with penalty.
The orders ultimately made by the Tribunal were as follows:16
(a)the two charges were found to be made out as professional misconduct;
(b)Dr Williams was censured;
(c)Dr Williams was fined $10,000;
(d)conditions were imposed on Dr Williams’ continued practice; and
(e)Dr Williams was ordered to pay $145,000 in costs.
Interim orders for name suppression were made. They have lapsed and Dr Williams’ name has since been published.
The notice of appeal
[22]Dr Williams in his notice of appeal alleges that the Tribunal erred:
(a)in determining that the theory of medicine or healing defence available under s 100(4) of the Act was not applicable;
(b)in failing either to consider, or to adequately consider, evidence that other practitioners had adopted and practiced the same theory of medicine or healing;
(c)by misdirecting itself with regard to the burden of proof on all aspects of the evidence;
(d)in failing to adequately direct itself, or adequately apply, “the principle of threshold requiring any conduct or omission on the part of [Dr Williams] to fall sufficiently seriously below appropriate standards so as to warrant an adverse disciplinary finding”;
16 At [236]-[240].
(e)in finding that Dr Williams’ conduct brought discredit to the medical profession;
(f)in all the circumstances, determining that an adverse disciplinary finding was required “for the purposes of the principles of discipline”; and
(g)in imposing the fine of $10,000.
Approach to the appeal
[23] The appeal is brought pursuant to s 106(2)(a) of the Act. It proceeds by way of rehearing pursuant to s 109(2). As a result, this Court is required to come to its own view on the merits, after considering and weighing all of the evidence that was before the Tribunal. The principles set out by the Supreme Court in Austin, Nichols & Co Inc v Stichting Lodestar apply.17 The appellant bears the onus of satisfying this Court on appeal that it should differ from the decision under appeal. It is only if this Court considers that the decision appealed against is wrong that it is justified in interfering with it. The position was summarised by Elias CJ as follows:
[16] Those exercising general rights of appeal are entitled to judgment in accordance with the opinion of the appellate court, even where that opinion is an assessment of fact and degree and entails a value judgment. If the appellate court's opinion is different from the conclusion of the tribunal appealed from, then the decision under appeal is wrong in the only sense that matters, even if it was a conclusion on which minds might reasonably differ. In such circumstances it is an error for the High Court to defer to the lower Court's assessment of the acceptability and weight to be accorded to the evidence, rather than forming its own opinion.
(Citations omitted)
[24] The consideration this Court should give to the Tribunal’s decision is a matter for this Court’s judgment.18 It may or may not find the reasoning of the Tribunal persuasive.19 It may be prepared to accept that the Tribunal had a particular advantage,
17 Austin, Nichols & Co Inc v Stichting Lodestar [2007] NZSC 103, [2008] 2 NZLR 141.
18 At [5].
19 At [5].
such as technical expertise, or the opportunity to assess the credibility of the witness.20 In such cases, this Court can properly hesitate before concluding that the Tribunal’s findings of fact or of fact and degree are wrong.21 Nevertheless, this Court has the responsibility of arriving at its own assessment of the merits of the case, and if it considers that the first instance decision was wrong, it must act on that view.22
[25] This Court can confirm, reverse or modify the Tribunal’s decision, and it can make any other decision or order that the Tribunal could have made.23 Instead of determining the appeal, it can direct the Tribunal to reconsider its decision either in whole or in part.24
Analysis
The Act
[26] The principle purpose of the Act is to protect the health and safety of members of the public by providing mechanisms to ensure that all health practitioners are competent and fit to practice their professions.25 The Act seeks to attain this purpose by, inter alia, providing a consistent accountability regime for all health professions.26
[27] Part 3 of the Act provides mechanisms for improving the competence of health practitioners – including those involved in the practice of medicine – and for protecting the public from those practitioners who practice below the required standard of competence, or who are unable to perform their required functions. It contains provisions allowing health practitioners involved in the practice of medicine to notify the Medical Council if they have reason to believe that another practitioner may pose a risk of harm to the public by practicing below the required standard of competence.27 The Medical Council, if it has reason to believe that the practice of a practitioner may
20 At [5].
21 At [5]. See also Johns v Director of Proceedings [2017] NZHC 2843 at [69].
22 At [5]. See also Cole v Professional Conduct Committee of the Nursing Council of New Zealand [2017] NZHC 1178 at [30] and [32]; A v Professional Conduct Committee [2018] NZHC 1623 at [4]-[5].
23 Health Practitioners Competence Assurance Act 2003, s 109(3).
24 Section 111(1).
25 Section 3(1).
26 Section 3(2)(a).
27 Section 34.
pose a risk of harm to the public, must give written notice of that fact to various persons.28 It can review a practitioner’s competence,29 and in certain cases, it can make an order for the interim suspension of a practitioner.30 The Act also provides mechanisms for upskilling practitioners, including the provision of competence programmes,31 recertification programmes,32 and the like.
[28] Part 4 of the Act is concerned with complaints and professional discipline. It establishes professional conduct committees to, inter alia, investigate complaints and, in appropriate cases, lay charges.33 It also establishes the Tribunal,34 which is charged with hearing and determining charges brought against practitioners by either the Director of Proceedings or by a Professional Conduct Committee. The Tribunal has the power to impose various penalties.35 It can cancel a practitioner’s registration or suspend his or her registration for a period not exceeding three years. It may order that a practitioner practice only in accordance with conditions imposed by the Tribunal. It can censure a practitioner and fine the practitioner a sum not exceeding
$30,000. It can also order that a practitioner pay part or all of the costs and expenses of, or incidental to, any investigation, inquiry, prosecution or hearing.
Professional misconduct
[29] The grounds on which health practitioners may be disciplined are set out in the Act. Relevantly, for present purposes, s 100(1) of the Act provides as follows:
(1)The Tribunal may make any 1 or more of the orders authorised by section 101 if, after conducting a hearing on a charge laid under section 91 against a health practitioner, it makes 1 or more findings that—
(a)the practitioner has been guilty of professional misconduct because of any act or omission that, in the judgment of the Tribunal, amounts to malpractice or negligence in relation to the scope of practice in respect of which the practitioner was registered at the time that the conduct occurred; or
28 Section 35.
29 Section 36.
30 Section 39.
31 Section 40.
32 Section 41.
33 Section 71.
34 Section 84.
35 Section 101(1)(a)-(f).
(b)the practitioner has been guilty of professional misconduct because of any act or omission that, in the judgment of the Tribunal, has brought or was likely to bring discredit to the profession that the health practitioner practised at the time that the conduct occurred;
…
[30] Dr Williams was charged with professional misconduct under s 100(1)(a) and/or (b).
[31] The term “professional misconduct” is not defined in the Act. For present purposes, there were two avenues open to the Tribunal:
(a)Under s 100(1)(a), a finding of professional misconduct was open to the Tribunal if it found that Dr Williams’ conduct detailed in the charges amounted to malpractice or negligence in relation to the scope of his practice as a general practitioner. The Courts have adopted the definition of the word “malpractice” contained in various dictionaries
– malpractice is immoral, illegal or unethical conduct, or a neglect of professional duties.36 A finding of negligence requires the Tribunal to determine whether or not the practitioner’s acts or omissions fall below the standards reasonably expected of a health practitioner in the circumstances of the person appearing before the Tribunal. Whether or not there has been a breach of the appropriate standards is measured against the standards of a reasonable body of the practitioner’s peers.37
(b)Under s 100(1)(b), a finding of professional misconduct was open to the Tribunal if, in its judgment, Dr Williams’ conduct detailed in the charges brought was likely to bring discredit to the medical profession.
It has been noted (in the context of the nursing profession) as follows:38
[28] To discredit is to bring harm to the repute or reputation of the profession. The standard must be an objective standard with the question to be asked by the Council being
36 See, for example, Cole v Professional Conduct Committee of the Nursing Council of New Zealand, above n 22, at [41].
37 At [42]; citing Nutall Med 04/03P at [62].
38 Collie v Nursing Council of New Zealand [2001] NZAR 74 (HC).
whether reasonable members of the public, informed and with knowledge of all the factual circumstances, could reasonably conclude that the reputation and good-standing of the nursing profession was lowered by the behaviour of the nurse concerned.
The observations apply also to the medical profession.
[32] As the charging body, the PCC had the burden of proving that Dr Williams’ conduct amounted to professional misconduct. This meant that it had the task of putting sufficient evidence before the Tribunal to satisfy it that the facts set out in the charges were proven, and that those facts were significant enough to amount to professional misconduct. The standard of proof was on the balance of probabilities, although in practice, stronger evidence was required of the more serious allegations.39
[33] A practitioner against whom a prima facie case has been made out must be prepared to answer the charge.40 If Dr Williams wished to rely on an affirmative defence, such as that available under s 100(4) of the Act, he had the onus of proving the facts on which the defence rested.41
[34] It is trite law that the Tribunal must apply a two-stage test to determine whether professional misconduct has been established.42 First, it must determine whether the practitioner’s acts or omissions constituted malpractice or negligence or have brought discredit to the medical profession. Secondly, it must determine whether the practitioner’s acts or omissions were significant enough to warrant disciplinary sanction for the purpose of protecting the public or maintaining professional standards.
[35] A finding of professional misconduct requires something that is significant enough to attract sanction. In B v Medical Council of New Zealand, Elias J (as she then was), considering an appeal against a finding of conduct unbecoming under earlier legislation, observed as follows:43
39 There is no intermediate standard of proof between the criminal and civil standards – Z v Dental Complaints Assessment Committee [2008] NZSC 55, [2009] 1 NZLR 1 at [102].
40 Auckland District Law Society v Leary HC Auckland M1471/84, 12 November 1985 at 18; Cole v Professional Conduct Committee of the Nursing Council of New Zealand, above n 22, at [36].
41 White v Attorney-General HC Wellington CIV-1999-485-85, CIV-2001-485-864, 28 November 2007 at [32]; Jia v Auckland Council [2018] NZHC 1133 at [107].
42 F v Medical Practitioners Disciplinary Tribunal [2005] 3 NZLR 774 (CA) at [77] and [80].
43 B v Medical Council of New Zealand HC Auckland HC11/96, 8 July 1996.
… it needs to be recognised that conduct which attracts professional discipline, even at the lower end of the scale, must be conduct which departs from acceptable professional standards. That departure must be significant enough to attract sanction for the purposes of protecting the public. Such protection is the basis upon which registration under the Act, with its privileges is available.
This observation has been followed in numerous cases since, and it continues to apply to cases under the Act.
[36] It follows that any particular act or omission amounting to negligence or malpractice, or bringing discredit to the medical profession, may or may not be sufficient to constitute professional misconduct. There must be behaviour which falls seriously short of that which is considered acceptable by competent, ethical and responsible practitioners, and must not be mere inadvertent error, oversight or carelessness.44 The Tribunal must assess whether the departure from acceptable standards has been significant enough to warrant a finding of professional misconduct against the practitioner.45 It should bear in mind that a finding of professional misconduct carries considerable stigma. It sends a very strong message about the practitioner’s failure to properly discharge his or her professional responsibilities. An adverse finding will likely be keenly felt by the practitioner, and it will inevitably be noted by his or her peers.46 A finding of professional misconduct is a significant matter, which is reserved only for serious conduct.47
The charges against Dr Williams – the matters raised on this appeal
[37]As I have already noted, the charges are annexed to this judgment.
[38] Dr Williams did not dispute the Tribunal’s findings in relation to patient 12. He accepted that he provided dietary advice to patient 12’s parents about the use of goat’s milk in circumstances that departed from accepted medical practice and/or that resulted in actual harm to patient 12. Nor did Dr Williams dispute the Tribunal’s finding that his keeping of patients’ medical histories was inadequate and in breach of
44 Collie v Nursing Council of New Zealand, above n 38, at [21].
45 Martin v Director of Proceedings [2010] NZAR 333 (HC) at [30]-[31].
46 Vatsyayann v Professional Conduct Committee HC Wellington CIV-2009-482-259, 14 August 2009 at [8]; Johns v Director of Proceedings, above n 21, at [84].
47 Cole v Professional Conduct Committee of the Nursing Council of New Zealand, above n 22, at [45].
acceptable standards. This was a particular alleged in respect of patients 1, 2, 3 and 12.
[39]I am precluded from reviewing these parts of the Tribunal’s decision.48
[40] There has been no appeal by the PCC under s 106(3) of the Act against the Tribunal’s dismissal of some of the particulars alleged in respect of some of the patients referred to in the charges. Again, I have not considered these parts of the Tribunal’s decision.
[41] Those parts of the charges which remain live on this appeal focus on Dr Williams’ prescription of betaclom, which is described as being “a combination of a potent topical steroid (betamethasone valerate 0.1%) and the anti-fungal cream (clomazol 1%)”. The charges refer to Dr Williams prescribing this combination to named patients, in circumstances which, it is said, amounted to professional misconduct. Inter alia, it is alleged that Dr Williams prescribed excessive quantities of betamethasone valerate 0.1% to infants, to other young children and to persons in circumstances when he knew, or ought to have known, that treatment with betamethasone valerate 0.1% was contraindicated – for example, where the patients had acne and/or where the patients had already been using betamethasone valerate for some time.
The potency of betamethasone valerate 0.1%
[42] Betamethasone valerate 0.1% is one of the ingredients in betaclom and it was common ground that the PCC had to prove that betamethasone valerate 0.1% was a potent topical steroid.
[43] Considerable evidence was adduced on this topic before the Tribunal but curiously, and unfortunately, it did not make an express finding in relation to it. Rather, the Tribunal stated as follows:49
48 Health Practitioners Competence Assurance Act, s 109(4)(a).
49 Professional Conduct Committee v Williams, above n 1.
22.Betamethasone valerate is an active topical corticosteroid. There was evidence about levels of its potency relative to other topical corticosteroids. Hydrocortisone is graded by Dr Oakley, Dermatologist, Hamilton, as a mild topical corticosteroid and other grades of potency can range from 2 – 25 times more potent than hydrocortisone (moderate), 100 – 150 times more (potent) and up to 600 times more (very potent). There are other classifications to which the Tribunal’s attention was drawn, one of which has 7 levels. There was also evidence that potency can depend on whether the betamethasone valerate is cream, lotion, foam or ointment.
23.The Tribunal is prepared to take as a guide the levels referred to by Dr Oakley but taking into account the other evidence and ranges mentioned. The percentage potency range that she refers to is useful.
[44] Before me, both counsel accepted that there was ample evidence on which a factual finding as to the potency of betamethasone valerate 0.1% could and should have been made. Rather than send the matter back to the Tribunal for reconsideration, both invited me to consider the evidence and make the missing factual finding.
[45]I have reviewed the available evidence.
[46] A number of tables were placed before the Tribunal which ranked the potency of various topical corticosteroids:
(a)There was a table prepared by Dr Amanda Oakley.50 She did not give evidence but her table was produced without objection in the course of the hearing before the Tribunal. It records that the potency of topical steroids depends upon the specific molecule, the amount that reaches the target cell, absorption through the skin, and formulation. It notes that topical steroids are medicines regulated by health authorities and that they are classified according to their strength. It uses, as a base for comparison, a mild topical steroid – hydrocortisone. It states that betamethasone valerate is considered to be a potent topical steroid and that it is 100 - 150 times more potent than hydrocortisone.
50 Dr Amanda Oakley Topical Steroids (DermNet New Zealand Trust, 1997; updated 4 January 2016).
(b)A publication by Medsafe dated December 2005 was also produced to the Tribunal.51 It classifies hydrocortisone 0.5% and 1% as being mildly potent and betamethasone valerate 0.1% as being potent.
(c)There was also a World Health Organisation publication – WHO Model Prescribing Information – Drugs used in Skin Diseases52 – which classifies topical corticosteroids in seven different classes. Classes 6 and 7 are recorded as having low potency. Hydrocortisone acetate is within Class 7. Betamethasone valerate cream 0.1% is in Class 5, and it is given a moderate potency ranking.
(d)There was an article – Corticosteroids: options in the era of steroid- sparing therapy – by James Del Rosso,53 produced to the Tribunal which contains a table setting out a corticosteroid potency chart. It also divides corticosteroids into seven classes. Class 7 – the least potent – includes hydrocortisone. Class 5 – said to be “lower mid strength” includes betamethasone valerate 0.1%, either in cream or lotion form.
It was common ground that betaclom contained betamethasone valerate 0.1% in cream form.
[47] In addition to these publications, various witnesses referred to the potency of betamethasone valerate 0.1%:
(a)Dr Rademaker, a dermatologist, said in his evidence-in-chief that betaclom contained a potent topical corticosteroid. He spoke of the relative potencies being 1% for hydrocortisone, with a 100-fold difference in potency for betamethasone valerate. He also gave evidence that the betamethasone valerate molecule is in the order of 100 times more potent than hydrocortisone.
51 Ruth Savage and Marius Rademaker Topical Corticosteroids: Face Facts (Medsafe, Prescriber Update 26(2): 30-31, December 2005).
52 World Health Organisation WHO Model Prescribing Information – Drugs used in Skin Diseases
(World Health Organisation, Geneva, 1997).
53 James Del Rosso Corticosteroids: Options in the era of steroid-sparing therapy (JAAD, Vol 53, Issue 1, July 2005).
(b)Dr Maplesden, a general practitioner called by the PCC, had prepared a report which was produced in evidence. It described betamethasone valerate 0.1% cream as being a potent topical steroid. Dr Maplesden adopted Dr Oakley’s table referred to above and also cited the Medsafe publication.
(c)Dr Jarrett, a consultant dermatologist who gave evidence regarding Dr Williams prescribing for two of the patients referred to in the charges, said that betamethasone valerate 0.1% “sits in the middle of the ladder [of potency] and is considered to be 100 to 150 times more potent than hydrocortisone”.
(d)Dr Purvis, a paediatric dermatologist called by the PCC, gave similar evidence, referring to betamethasone valerate 0.1% as being a potent topical steroid.
(e)So did Dr Rowan, a consultant dermatologist.
(f)Mr Woods, a pharmacist called to give expert evidence before the Tribunal, accepted that Dr Oakley’s table could appropriately be used by the Tribunal. In his evidence-in-chief, he stated that betamethasone valerate 0.1% is a potent topical corticosteroid. When he was cross- examined, he also referred to the “ladder” of potency, and accepted that betamethasone valerate 0.1% sits “somewhere in the middle”. He was referred to the document noted above in [46](d), and he accepted that according to that table, betamethasone valerate 0.1% is a lower mid- strength topical corticosteroid.
(g)Dr Williams, in cross-examination, acknowledged that he knew that betamethasone is a potent steroid.
[48] While there were differences in emphasis, I do not consider that there was any significant divergence in opinion. Accordingly, I am prepared to make the finding which the Tribunal failed to make. I am satisfied, on the balance of probabilities, that
betamethasone valerate 0.1% is a moderately potent topical corticosteroid – approximately 100 to 150 times more potent than the mild topical corticosteroid, hydrocortisone. The Tribunal should have made an express finding to this effect. I do so.
Did the potency of betamethasone valerate 0.1% change when it was mixed with clomazol to make betaclom?
[49]The Tribunal dealt with this issue under the heading “Betaclom – potency”.
[50] Before me, there was considerable argument as to whether or not the evidential onus on this issue was on the PCC or on Dr Williams.
[51] The charges refer to Dr Williams prescribing a combination of betamethasone valerate 0.1% and clomazol 1%, and the particulars refer specifically to him prescribing betamethasone valerate 0.1% – as one of the components of betaclom – to named patients. The PCC was required to prove, on the balance of probabilities, that Dr Williams prescribed betamethasone valerate 0.1% to the named patients, and that such prescribing, in the circumstances detailed in the charges, amounted to professional misconduct. To do this, the PCC had to establish the potency of betamethasone valerate in the combination prescribed. The onus in this regard was on the PCC. To the extent that Dr Williams was relying on a belief that the potency of betamethasone valerate 0.1% was reduced by mixing it with clomazol, and/or that the betamethasone valerate 0.1% was diluted, as part of his “theory of medicine or healing” defence under s 100(4) of the Act, then the onus was on him to establish this, also on the balance of probabilities.
[52] In practice, I do not think that it makes much difference in this case, because there was in my judgment ample evidence on which the Tribunal could properly conclude that the steroid effect of the betamethasone valerate 0.1% in the betaclom combination prescribed by Dr Williams was no less potent than the betamethasone valerate 0.1% component in the betaclom. I refer to the following evidence:
(a)The primary witness in regard to this issue was the pharmacist – Mr Woods. He gave evidence about the difference between
concentration (the weight or volume of an ingredient) and potency (the activity) of a drug. He said that, when dealing with a potent drug in a topical preparation, “changing the concentration … may have little influence on pharmacological effect”. As to whether the potency of betamethasone valerate 0.1% was reduced when it was mixed with an anti-fungal medicine, such as clomazol, he said:
There has been considerable discussion going back over 20 years, backed up by experimental evidence, that indicates that dilution of potent topical corticosteroids (including betamethasone valerate) in various bases does not lead to a reduction in potency and a reduction in the effect of the steroid as measured by standard measures.
Dealing specifically with betaclom, Mr Woods said that the potency of the betamethasone valerate component in the compound would not be reduced by dilution, and that dilution would not reduce the adverse effects of the betamethasone valerate. He said that there are numerous publications and guidelines from the 1980’s onwards which not only caution against dilution of a potent steroid, but which go on to advise that a lower potency agent should be used rather than an attempt made at dilution.
(b)Dr Maplesden said that there is little point in diluting a topical steroid, as its potency is not dependent on concentration. He said that there is robust clinical evidence to the effect that the dilution of steroid creams does not reduce their potency at a dermal level. He said that he had been unable to find similar evidence supporting a contrary view.
(c)Dr Rademaker said that Dr Williams erred in his belief that mixing betamethasone valerate with another base reduced the potency of the mixture. He stated:
So, effectively, diluting a steroid by half just doubles the amount of steroid you’re giving that patient. So, if you diluted
300 grams of betamethasone with clomazol in a similar quantity, you’re actually giving 600 grams of the betamethasone clomazol mixture.
(d)Similarly, Dr Purvis said that diluting steroid creams by adding another substance does not reduce the potency of the steroid.
(e)Dr Williams partially accepted the views expressed by other witnesses. He said in his evidence-in-chief:
I am aware that the ‘potency’ of the steroid molecules is not changed by mixing the [betaclom] cream preparation. The molecules and how they function remain the same.
However, contrary to other witnesses, he did go on to assert that the percentage of active steroid ingredients in betaclom did change – i.e. that it was diluted.
[53] All of this evidence points strongly to the conclusion that the potency of the betamethasone valerate 0.1% was not reduced when it was mixed with clomazol, and that there was no change in its side effects.
[54] Mr Waalkens QC, on behalf of Dr Williams, however placed considerable weight on an answer given by Mr Woods in the course of cross-examination.
[55] Mr Woods was shown an article published in a specialist pharmaceutical publication,54 dealing with a drug called betamethasone-17-valerate, and reporting that when it was mixed with a hydrophilic cream, the resulting product possessed only a fraction of the potency of the initial betamethasone-17-valerate parent compound. Mr Waalkens submitted that, when he was referred to this article, Mr Woods accepted that when betamethasone valerate 0.1% was mixed with clomazol, it may have been that the compound product was less potent than the betamethasone valerate on its own. Ms Miller’s response, on behalf of the PPC, was to argue that Mr Woods’ evidence needed to be read in context and in full.
[56]The relevant passage in the notes of evidence is relatively lengthy. I set it out:
54 Jonathan Byrne and others Formulation factors affecting the isomerization rate of betamethasone- 17-valerate in a developmental hydrophilic cream - a HPLC and microscopy based stability study (Pharm Development and Technology, 22(4): 537-544, June 2017).
Q. … as we talked about earlier in terms of the potency of the betamethasone being wrapped up in that ester, one of the issues with the cream or that molecule is it’s susceptible to an acid and base catalysed isomerization?
A. Correct, yes.
Q.And so if it goes through that isomerization process, it loses, forgive me for the way I am explaining it, but it loses its esterification and it becomes less potent doesn’t it?
A. I don’t know if I can actually make that leap in logic. There’s obviously going to be some changing chemical structure but I don’t know –
Q. If you look at the article, “This isomerization process is of significant clinical relevance since betamethasone-21-valerate demonstrates only 1/15th of the potency”, see that?
A. Reading that paragraph, yes, that’s true.
…
Q. And you agreed with me earlier that the clomazol was an alkaline substance?
A. The drug is an alkaline substance but clomazol was the product, so I don’t know if the product is an alkaline substance.
Q. Go back to the data sheet for that, page 23, clotrimazole, it is a reference to that molecule?
A. Yes, that’s correct.
Q. Would it be normal to put that alkaline molecule in an alkaline molecule in an alkaline base?
A. I don’t know. It depends on – formulation science is actually a very complicated area. It depends on the activity of the antimicrobial, the stabilising agent. So, it’s very difficult to make generalisations. We can’t assume that because clotrimazole is actually alkaline, that the base would necessarily be alkaline.
Q.So, if we can treat it in this way then, Mr Woods, it’s possible, isn’t it, that the clotrimazole is itself alkaline; just accept that as a hypothetical?
A. It’s possible, yep.
Q. And if that’s mixed with the beta cream then you would expect the overall pH of the mixture to change from the beta cream on its own, wouldn’t you?
A.Yep, because you’re mixing two different products, so the effects on the pH would be, without measuring it, would be quite unpredictable.
Q. And so –
CHAIR: It is assuming it’s alkaline based in the first place?
A. That’s right, yes. We’re dealing with a lot of unknowns here.
MR HOLLOWAY:
Q. The point is this, Mr Woods, is that in terms of these patients in the charges, and this is not an issue for you, there has been evidence about side effects or lack thereof and there will certainly be evidence from Dr Williams about the lack of side effects seen in using this mixture.
A. Yep.
Q.The reason for that may well be because he’s right, that it is when mixed with the clomazol less potent than the beta cream on its own?
A.That’s correct. It could be but the evidence indicates that that’s unlikely but the main issue is unpredictability. The evidence suggests that dilution of potent corticosteroids does not predictably reduce potency but, as you’ve been working through here, the effects on a formulation by mixing two products together, unless you study that particular formulation, we don’t actually definitively know. We may be able to glean from clinical response but we don’t actually know the effects of the formulation.
Q. So, when you said a moment ago, you referred again to those studies using normal dilutants.
A. Mm-mmm.
Q. That’s one way of looking at it and inferring that situation with clomazol will be the same but, as you’ve said, and tell me if I’m right, it may well not be the same?
A. Correct.
Q. And another way of gathering evidence about the effect of the mixture, of course, is to observe it in clinical practice?
A. That’s one way, yep, but that would have to be – normally when we’re looking at the effects of the medicine, it is a little bit more than observation in clinical practice. We need a controlled study against a benchmark comparison.
Q.Just taking you back to the key point, Mr Woods. When you say that, in your opinion, the potency is unlikely to be affected, and you base that on the studies from some decades ago that were in a particular setting, am I right that in respect of this particular combination, moving from the application of this hypothetical to the reality of what’s being mixed, is it true that you just don’t know whether or not it will be less potent or not without studying it?
A. Oh, that’s true, that’s true.
[57] I agree with Ms Miller. The answer relied on by Mr Waalkens (set out in italics above) has to be considered in context. I note the following. First, Mr Woods’ answer was based on a hypothetical assumption – that the formulation, clomazol, is alkaline. Secondly, Mr Woods was very careful with his answers – for example, “I don’t know if I can actually make that leap in logic”; “we’re dealing with a lot of unknowns here”. Thirdly, the relevance of a publication dealing with different drugs – betamethasone- 17-valerate and a developmental hydrophilic cream – was not established. Fourthly, insofar as I am aware, there was no evidence that the publication had been peer reviewed. Finally, Mr Woods’ answer was equivocal – “it could be” that the betamethasone valerate 0.1% was diluted, and he hedged the answer by going on to say that he considered this unlikely. The main issue for him was the predictability of the resulting compound.
[58] Dr Rademaker was also questioned about the publication by a member of the Tribunal. Dr Rademaker accepted that it is possible that the betamethasone valerate had reduced potency and reduced side effects when mixed into betaclom, but it was his evidence that generally, doctors do not mix proprietary preparations because doing so can change the activity of the active ingredients.
[59] The Tribunal’s discussion of this evidence was brief. It noted that Mr Woods was asked about the thesis in the publication, “but none of his answers … undermined the expert evidence he and others had given”.55 It also noted that there was no expert
55 Professional Conduct Committee v Williams, above n 1, at [38].
evidence to the contrary called by Dr Williams. The Tribunal did not expressly refer to Dr Rademaker’s evidence.
[60] Dr Williams has not persuaded me that the Tribunal’s conclusion was wrong. The Tribunal took into account Dr Williams’ belief that the potency of betamethasone valerate 0.1% was reduced by dilution when it was mixed with clomazol to make betaclom. It referred to much of the evidence which was led in relation to the topic (which I have summarised). It did not consider that Mr Woods’ answer to a hypothetical question based on assumptions which may or may not have been correct undermined the preponderance of the evidence it had heard. It was entitled to take that view. In my judgment, the Tribunal did not err when it concluded, on the balance of probabilities, that the steroid effect in the betaclom was no less potent than that of the betamethasone valerate 0.1% component of the betaclom.
Guidelines and datasheets
[61] Having reached this point, it seems to me that the next step is to consider when betamethasone valerate 0.1% could be used and when it should not be used.
[62] The Tribunal did not directly address this issue, but it did, at various places in its decision, refer to several guidelines and datasheets that were produced to it relevant to the use of betamethasone valerate 0.1%. These included the following:
(a)A 2005 datasheet headed “Information for health professionals - Beta”. This datasheet recorded that beta creams, containing betamethasone valerate 0.1%, were indicated for the treatment of eczema. It recorded as contraindications, situations where patients had acne vulgaris, or where children under one year of age had dermatoses. The use of fluorinated steroids was contraindicated on the face. It also warned that long-term continuous therapy using topical corticosteroids should be avoided where possible, especially in infants and children, and that infants and children under four years old should not be treated with topical steroids for longer than three weeks without medical review.
(b)There were similar updated datasheets in February 2009, March 2010 and April 2014.
(c)A datasheet produced by the Medical Council of New Zealand headed “Good prescribing practice” which recorded that a doctor should only prescribe medicines or treatment when he or she had adequately assessed the patient’s condition and had adequate knowledge of the patient’s needs. It recorded that a doctor, to ensure that prescribing is appropriate and responsible, should be familiar with the indications, side effects, contraindications, major drug interactions, appropriate dosages, effectiveness and cost-effectiveness of the medicines prescribed. It warned against prescribing indiscriminately, excessively or recklessly, and cautioned that prescribing should take place in accordance with accepted practice and any relevant best practice guidelines. It also cautioned that prescribing outside of accepted norms should only occur in special circumstances with the patient’s informed consent, and that in such circumstances, it could be useful to discuss the proposed treatment with a senior colleague before completing the prescription. It advocated for the periodic review of the effectiveness of such treatment and required that a clear and adequate patient record be kept. Under the heading “Prescribing unapproved medicines”, it stated as follows:
You may prescribe unapproved medicines or prescribe medicines for a purpose for which they have not been approved but, if you decide to do so, you should take responsibility for overseeing the patient’s care, including monitoring and any follow-up treatment. You may also like to discuss the patient’s treatment with a senior colleague. You should also inform the patient:
· whether there are any other options available
· of any risks, side effects, costs or benefits
· that the medicine being prescribed is for an unapproved use
· that details relating to the supply of the unapproved medicine will be supplied to the Director-General of Health.
…
(d)The National Institute for Health and Care Excellence (NICE) Clinical guideline – “Atopic Eczema in under 12’s: diagnosis and management”.
(e)The Scottish Intercollegiate Guidelines Network (SIGN) – “Management of Atopic Eczema in primary care – A National Clinical Guideline”.
[63] Mr Waalkens was critical of an observation made by the Tribunal in its decision that prescription must be within accepted guidelines and in compliance with applicable datasheets.56 He noted that both the SIGN and NICE guidelines record that they are not mandatory, and he criticised the Tribunal for making no reference to this fact. He also noted that Dr Williams was not charged with breaching the guidelines.
[64] I agree with Mr Waalkens that such guidelines and the datasheets are not mandatory. The relevance of the guidelines and the datasheets was that they set out in convenient and summary form what is commonly accepted as being good practice within the medical profession for the use of topical corticosteroids. They are evidence based guidance, derived over time. The datasheets, in particular, assist general practitioners in ensuring that drugs are used appropriately. The guidelines do not exclude other methods of care, but they do guide health practitioners in treating their patients.
[65] Dr Williams was aware of the NICE guidelines. He initially said that he had followed the guidelines, but when he was cross-examined in this regard, he accepted that he had probably not followed all of it, but rather most of it. He was not aware of the SIGN guidelines, and he accepted that he had not come across them in his research into the treatment of eczema. He accepted, with hindsight, that he should reasonably have looked at or for other guidelines on the treatment of eczema when he was undertaking his initial research. Dr Williams was cross-examined about his knowledge of the Medsafe datasheets. He accepted that he was familiar with the
56 Professional Conduct Committee v Williams, above n 1, at [77].
contraindications in those datasheets relating to the use of betamethasone. He nevertheless defended his use of betaclom containing betamethasone valerate 0.1%, and asserted that he had not acted in a way inconsistent with the information given in the datasheets.
[66] Despite the criticisms levelled against the Tribunal’s decision, again, I am not persuaded that the Tribunal erred in its approach to this matter. When it turned to deal with the particulars of each charge, it paid careful regard to the circumstances of each patient, and Dr Williams’ prescribing to the patients concerned. It did so by reference to the datasheets and guidelines, but it did not apply them inflexibly.
[67] Before considering the charges in a little more detail, it is necessary to consider the theory of medicine or healing defence raised by Dr Williams.
Section 100(4) of the Act
[68]Section 100(4) reads as follows:
No person may be found guilty of a disciplinary offence under this Part merely because that person has adopted and practised any theory of medicine or healing if, in doing so, the person has acted honestly and in good faith.
Dr Williams relied on this provision.
[69]In its oral decision, the Tribunal said as follows:
One matter relied on by Dr Williams arises under section 104 of the [Act]. The submissions for Dr Williams was that his practice was a theory of medicine or healing, in respect of which he had acted honestly and in good faith. The Tribunal does not accept that the application of Beta/clom as such was a theory of medicine or healing. Beta/clom is a combination of two well-known drugs. The fact that Dr Williams used these in combination does not create a theory of medicine. There is evidence of sequential use by others of each of the components of Beta/clom but it is the combination that the charges address. So, that being so, there is no need to consider other aspects of section 100(4) which the Tribunal finds does not apply.
[70]The Tribunal reiterated this in its written decision. It said as follows:57
47. The first question raised by [s 100(4)] is whether the practitioner, in this case Dr Williams, “has adopted and practised any theory of medicine or healing” …
48. The combined product, Betaclom, is nothing more than a mixture of two other medicines, betamethasone valerate and clomazol. Those medicines have their own function and appropriate use and, as Dr Williams’ submissions also accept, they can be used and are used from time to time in combination. As noted above, this is clearly within the parameters that the medications call for, including from the Medsafe Data Sheets.
49. If Dr Williams’ theory of medicine is that the dilution of potency of the betamethasone valerate by the addition of clomazol, which was thought by him, he says, at the time to be the case, then that theory of medicine still does not escape the inevitable fact that the combination was still in the significantly potent category. Any honest belief or acting in good faith by Dr Williams in that regard does not create a new theory of medicine.
50. The proper use of topical corticosteroids is an accepted medicine practice. Even if dilution of the potency of these was thought (wrongly) to exist, the same considerations apply in respect of the use of what would still be a potent topical corticosteroid.
51. The Tribunal does not accept that section 100(4) of the HPCA Act is available to Dr Williams.
[71] Mr Waalkens was critical of the Tribunal’s reasoning. He argued that it placed an overly restrictive interpretation on the meaning of s 100(4) and that no (or no adequate) reasoning was provided by the Tribunal as to why compounding medicines cannot be regarded as a theory of medicine or healing, coming within the statutory defence.
[72] Ms Miller submitted that the Tribunal was correct in finding that the theory of medicine or healing defence did not apply.
[73] The leading New Zealand case on the theory of medicine or healing defence is the decision of the full bench of this Court in Tizard v Medical Council of New Zealand.58 The Court was there dealing with the Medical Practitioners Act 1968. It contained the same defence and it was available when a practitioner was charged with
57 Professional Conduct Committee v Williams, above n 1.
58 Tizard v Medical Council of New Zealand HC Auckland M2390/91, 10 December 1992.
disgraceful conduct. The Court first determined what is meant by the words “honestly and in good faith”. It held as follows:59
We accordingly hold that the meaning of “honestly and in good faith” is simply “honestly”. That does not mean that it is sufficient in every case to exclude liability for what would otherwise be disgraceful conduct that the practitioner concerned be acting “honestly”. That cannot be the case, since the use of the words “merely because” in s 58(4) make it plain that honest belief in the efficacy of a particular theory is not necessarily a sufficient answer.
It does however mean, in our view, that the Council was incorrectly advised that the words “in good faith” added an objective test of reasonableness to the subjective requirement of honesty. That makes it necessary to consider how far that mistake may have affected the Council’s decisions on the various charges, and whether it may have resulted in some substantial error or miscarriage of justice.
After considering various overseas authorities, the Court noted as follows:60
(c) Prescribed a combination of betamethasone valerate 0.1 and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or
6.Patient 6: Dr Williams first saw Patient 6 on or around 10 August 2012 when he was 17 months old. He diagnosed Patient 6 with moderately severe eczema generalised to his face, neck, arms, legs and trunk. Dr Williams prescribed (among other things) betamethasone valerate 0.1% twice daily and clomazol 1% twice daily, and again prescribed this treatment on 19 October 2012 and 18 September 2013. In doing so, Dr Williams:
(a) Prescribed betamethasone valerate 0.1% to a young child, including for application to the child’s face, when he knew or ought to have known that this treatment was contraindicated for use on the face and/or departed from accepted practice and/or may have posed a risk of harm to the patient; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Prescribed a combination of betamethasone valerate 0.1% and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or.
7.Patient 7: Dr Williams first saw Patient 7 on 19 October 2011, one day before Patient 7’s first birthday. He diagnosed Patient 7 with moderate atopic dermatitis/eczema, affecting his face, neck, arms, legs and trunk. Dr Williams prescribed betamethasone valerate 0.1% twice daily and clomazol 1% twice daily, and prescribed this combination of medication again on 21 September 2012 and 3 March 2014. In doing so, Dr Williams:
(a) Prescribed betamethasone valerate 0.1% to a young child, including for application to the child’s face, when he knew or ought to have known that this treatment was contraindicated for use on the face and/or departed from accepted practice and/or that may have posed a risk of harm to the patient; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Prescribed a combination of betamethasone valerate 0.1 and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment.
8.Patient 8: Dr Williams first saw Patient 8 on 22 October 2013, when he was two months old. Dr Williams diagnosed him with severe seborrhoeic eczema generalised to scalp with cradle cap, face, ears, neck, arms, legs and trunk. He prescribed betamethasone valerate 0.1% twice daily and clomazol 1% twice daily, and prescribed this combination of medication again on 29 October 2013. In doing so, Dr Williams:
(a) Prescribed an excessive amount of betamethasone valerate 0.1% (100g in one week) to a young child, including for application to the child’s face, in
circumstances that departed from accepted practice and/or may have posed a risk of harm to the patient; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Prescribed a combination of betamethasone valerate 0.1% and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or
9.Patient 9: Dr Williams first saw Patient 9 on 24 September 2004 when she was three years old. He diagnosed her with infantile eczema. Dr Williams prescribed betamethasone valerate 0.1% twice daily and clomazol 1% twice daily (and/or another antifungal cream) on or around 11 occasions between 21 April 2006 and 7 January 2015. In doing so, Dr Williams:
(a) Prescribed betamethasone valerate 0.1% over a nearly 9 year period without an adequate record of the appropriateness of the continued treatment, and/or without any record of considering the use of a less potent steroid cream, or a different form of therapy, as is standard clinical practice; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Prescribed betamethasone valerate 0.1% and clomazol 1% on 1 July 2014; 15 July 2014; 24 September 2014; and 7 January 2015 when he knew or ought to have known that the Medical Council had issued a notice under
section 35 of the Health Practitioners Competence Assurance Act 2003 on 4 June 2014 due to concerns that Dr Williams’ “prescribing to children of his own formula of a topical steroid and antifungal for the treatment of skin disorders poses a risk of harm”; and/or
(d) Prescribed betamethasone valerate 0.1% and clomazol 1% on 24 September 2014 and 7 January 2015 despite recording in the clinical notes on 24 September 2014 that Patient 9’s dermatologist had advised her “not to use B/C” (Beta/Clom); and/or
(e) Continued to prescribe a combination of betamethasone valerate 0.1% and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or
10.Patient 10: Dr Williams first saw Patient 10 on 15 April 2014 when she was ten months old. He diagnosed her with mild eczema to the face, neck, arms and legs. Dr Williams prescribed (among other things) betamethasone valerate 0.1% twice daily and clomazol 1% twice daily. In doing so, Dr Williams:
(a) Prescribed betamethasone valerate 0.1% to a young child, including for application to the child’s face when he knew or ought to have known that this treatment was contraindicated and/or departed from accepted practice and/or may have posed a risk of harm to the patient; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Failed to moderate his method of treatment (namely the combination of potent topical steroid and antifungal cream) having regard to the severity of Patient 10’s symptoms, which were described as mild, and by failing to prescribe a mild topical steroid; and/or
(d) Prescribed a combination of betamethasone valerate 0.1% and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or
11.Patient 11: Dr Williams first saw Patient 11 on 16 October 2013. He diagnosed her with moderate psoriasis and prescribed (among other things) betamethasone valerate 0.1% twice daily, clomazol 1% twice daily, and daivobet 50/500 30g once daily, and prescribed the combination of betamethasone and clomazol treatment again on 21 October 2013; 30 October 2013; and 9 December 2013, and prescribed daivobet again on 30 October 2013 and 9 December 2013. In doing so, Dr Williams:
(a) Prescribed excessive quantities of betamethasone valerate 0.1% (approximately 500g in 3 months) and daivobet 50/500 (approximately 200g in 3 months), where such prescribing departed from accepted practice and/or may have posed a risk of harm to the patient; and/or
(b) Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(c) Prescribed a combination of betamethasone valerate 0.1 and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment.
AND/OR
B. On or around 12 June 2015 Dr Williams provided dietary advice about the use of goat’s milk to the parents of 22 month old Patient 12 in circumstances that departed from accepted medical practice and/or that resulted in actual harm to the patient (life- threatening anaphylactic reaction). In addition, Dr Williams:
(a)Failed to adequately assess Patient 12’s condition, including by:
(i)Failing to elicit and/or take into account Patient 12’s full allergy history (namely her severe food allergy and previous cow’s milk anaphylaxis) prior to suggesting dietary changes; and/or
(ii)Failing to read and/or to take into account Patient 12’s clinical notes which included: “warning: anaphylactic allergy to cow’s milk & dairy products”; and/or
(b)Failed to document an adequate medical history and/or assessment, including by:
(i)Failing to record any reference to Patient 12 having been under the care of Starship Hospital, when he knew or ought to have known that she had been under hospital care; and/or
(ii)Failing to record the advice provided to Patient 12’s parents about the use of goat’s milk.
The conduct alleged above either separately or cumulatively amounts to professional misconduct pursuant to section 100(1)(a) and/or section 100(1)(b) of the Act.
Dated at Auckland this day of May 2017
Dr Paul Hogg
Convenor
Professional Conduct Committee
SCHEDULE
Correspondence and events relating to the concerns raised about Dr Williams’ prescribing
(a)14 September 2011: letter from Dr Campbell Brebner (GP Liaison Counties Manukau DHB) to Dr Williams “regarding a concern that has been brought to our attention related to an aspect of your prescribing”. This letter attached an email dated 26 August 2011 from Dr Darion Rowan to the CMDHB CMO about Dr Williams’ “special cream” (a combination of a potent topical steroid (betamethasone valerate 0.1%) and an antifungal cream (clomazol 1%) (“Beta/Clom”)) and a table of cases where Beta/Clom had been prescribed to patients. On 23
September 2011 Dr Williams’ replied to Dr Brebner.
(b)10 April 2012: Dr Gloria Johnson made a complaint to the Medical Council about Dr Williams’ use of steroids. Her letter attaches correspondence from Dr Rowan dated 12 March 2012, which raised concerns about Dr Williams’ use of “Betaclom”. Dr Williams was advised of the complaint, which resulted in a competence review.
(c)12 March 2013: Dr Paul Jarrett wrote to Dr Williams about his prescribing of Beta/Clom to a patient, noting (among other things) that:
The adverse side effects of excessive topical steroid use includes suppression of endogenous steroid production, iatrogenic Cushing’s syndrome, skin thinning, easy bruising, perioral dermatitis, telangectasis formation, striae formation and susceptibility to cutaneous infection.
General advice is not to use a potent steroid for more than three weeks.
Dr Williams replied to Dr Jarrett on 27 March 2013.
(d)5 March 2014: Dr Purvis made a complaint to the Medical Council about aspects of Dr Williams’ practice, including his prescribing of “the same
topical potent steroid/clotrimazole combination cream…” Dr Williams was
advised of the complaint, which resulted in the PCC investigation.
(e)4 April 2014: Dr Purvis copied Dr Williams into a letter raising concerns about the quantity of topical beta cream prescribed to Patient 1.
(f)7 May 2014: Dr Purvis made a further complaint to the Medical Council about Dr Williams’ prescribing of this treatment. Dr Williams was advised of the further complaint.
(g)4 June 2014: The Medical Council issued a notice of risk of harm under section 35 HPCA Act relating to Dr Williams’ prescribing of “his own formula of a topical steroid and antifungal”.
(h)10 September 2014: Dr Jarrett made a complaint to the Medical Council about the prolonged use of Beta/Clom prescribed by Dr Williams for two patients (Patient 5 and Patient 4).
IN THE MATTER OF the Health Practitioners Competence
Assurance Act 2003
AND
IN THE MATTER OF Joseph Williams, registered medical
practitioner of Auckland
DISCIPLINARY CHARGE
TAKE NOTICE that a Professional Conduct Committee of the Medical Council established under section 71 of the Health
Practitioners Competence Assurance Act 2003 (“the Act”) has determined in accordance with section 80(3)(b) of the Act that a disciplinary charge should be brought against Dr Joseph
Williams before the Health Practitioners Disciplinary Tribunal.
The Professional Conduct Committee has reason to believe
that grounds exist entitling the Tribunal to exercise its powers under section 100 of the Act.
PARTICULARS OF CHARGE
Pursuant to section 81(2) of the Act, the Professional Conduct Committee lays a charge against Dr Williams that, between on or around April 2013 to November 2015, Dr Williams prescribed a combination of a potent topical steroid (betamethasone valerate 0.1%) and an antifungal cream (clomazol 1%) to
Patient 13 in circumstances that amounted to professional misconduct, as follows:
1. Dr Williams first saw Patient 13 on 15 April 2013. He diagnosed her with atopic dermatitis/eczema and prescribed (among other things) betamethasone valerate 0.1% cream twice daily and clomazol 1% cream twice daily. He saw Patient 13 again on 29 April 2013. Dr Williams recorded that she had facial acne and prescribed the same combination of medication (betamethasone valerate 0.1% cream and clomazol 1% cream). On 4 December 2013, Dr Williams diagnosed Patient 13 with acne vulgaris and prescribed the same combination of medication. Dr Williams prescribed this combination of medication again on 1 December
2014, 23 December 2014, 25 March 2015 and 2 November 2015. In doing so, Dr Williams:
(d)Prescribed betamethasone valerate 0.1% for use on the face, and in the presence of acne, when he knew or ought to have known that this treatment was contraindicated and/or departed from accepted practice and/or may have posed a risk of harm to the patient; and/or
(e)Prescribed an antifungal cream, clomazol, in circumstances where there was no record or report of a fungal infection, such that the prescribing was not clinically justified; and/or
(f)Prescribed a combination of betamethasone valerate 0.1% and clomazol 1% when he knew or ought to have known that repeated concerns (as detailed in the attached schedule) had been raised about his prescribing of this treatment; and/or
(g)Prescribed betamethasone valerate 0.1% after 5 October 2015 when he knew or ought to have known that his colleague had advised Patient 13 to see a dermatologist.
The conduct alleged above either separately or cumulatively amounts to professional misconduct pursuant to section 100(1)(a) and/or section 100(1)(b) of the Act.
Dated at Auckland this day of May 2017
Dr Paul Hogg
Convenor
Professional Conduct Committee
SCHEDULE
Correspondence and events relating to the concerns raised about Dr Williams’ prescribing
(a)14 September 2011: letter from Dr Campbell Brebner (GP Liaison Counties Manukau DHB) to Dr Williams “regarding a concern that has been brought to our attention related to an aspect of your prescribing”.
This letter attached an email dated 26 August 2011 from Dr Darion Rowan to the CMDHB CMO about Dr Williams’ “special cream” (a combination of a potent topical steroid (betamethasone valerate 0.1%) and an antifungal cream (clomazol 1%) (“Beta/Clom”)) and a table of cases where Beta/Clom had been prescribed to patients. On 23 September 2011 Dr
Williams’ replied to Dr Brebner.
(b)10 April 2012: Dr Gloria Johnson made a complaint to the Medical Council about Dr Williams’ use of steroids. Her letter attaches correspondence from Dr Rowan dated 12 March 2012, which raised concerns about Dr Williams’ use of “Betaclom”. Dr Williams was advised of the complaint, which resulted in a competence review.
(c)12 March 2013: Dr Paul Jarrett wrote to Dr Williams about his prescribing of Beta/Clom to a patient, noting (among other things) that:
The adverse side effects of excessive topical steroid use includes suppression of endogenous steroid production, iatrogenic Cushing’s syndrome, skin thinning, easy bruising, perioral dermatitis, telangectasis formation, striae formation and susceptibility to cutaneous infection.
General advice is not to use a potent steroid for more than three weeks.
Dr Williams replied to Dr Jarrett on 27 March 2013.
(d)5 March 2014: Dr Diana Purvis made a complaint to the Medical Council about aspects of Dr Williams’ practice, including his prescribing of “the same topical potent steroid/clotrimazole combination cream…” Dr Williams was advised of the complaint, which resulted in the PCC investigation.
(e)4 April 2014: Dr Purvis copied Dr Williams into a letter raising concerns about the quantity of topical beta cream prescribed to a young child.
(f)7 May 2014: Dr Purvis made a further complaint to the Medical Council about Dr Williams’ prescribing of Beta/Clom treatment. Dr Williams was advised of the further complaint.
(g)4 June 2014: The Medical Council issued a notice of risk of harm under section 35 HPCA Act relating to Dr Williams’ prescribing to children of “his own formula of a topical steroid and antifungal”.
(h)10 September 2014: Dr Jarrett made a complaint to the Medical Council about the prolonged use of Beta/Clom prescribed by Dr Williams to two patients with acne.
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