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Record of Determinations – Medical Practitioners Tribunal MPT: Dr LEWIS 1 PUBLIC RECORD Dates: 20/01/2020 - 27/01/2020 Medical Practitioner’s name: Dr Nader LEWIS GMC reference number: 3050541 Primary medical qualification: MB BCh 1971 Ain Shams University Type of case Outcome on impairment New - Misconduct Impaired Summary of outcome Erasure Immediate order imposed Tribunal: Legally Qualified Chair Mr William Hoskins Lay Tribunal Member: Mrs Sue Wadham Medical Tribunal Member: Dr John Garner Tribunal Clerk: Mr Laurence Millea Attendance and Representation: Medical Practitioner: Not present and not represented Medical Practitioner’s Representative: N/A GMC Representative: Ms Eleanor Fry, Counsel Attendance of Press / Public In accordance with Rule 41 of the General Medical Council (Fitness to Practise) Rules 2004 the hearing was held in public.

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Page 1: PUBLIC RECORD - MPTS · 2020-02-13 · Record of Determinations – Medical Practitioners Tribunal MPT: Dr LEWIS 1 PUBLIC RECORD Dates: 20/01/2020 - 27/01/2020 Medical Practitioner’s

Record of Determinations –

Medical Practitioners Tribunal

MPT: Dr LEWIS 1

PUBLIC RECORD Dates: 20/01/2020 - 27/01/2020

Medical Practitioner’s name: Dr Nader LEWIS

GMC reference number: 3050541

Primary medical qualification: MB BCh 1971 Ain Shams University

Type of case Outcome on impairment New - Misconduct Impaired

Summary of outcome

Erasure Immediate order imposed

Tribunal:

Legally Qualified Chair Mr William Hoskins

Lay Tribunal Member: Mrs Sue Wadham

Medical Tribunal Member: Dr John Garner

Tribunal Clerk: Mr Laurence Millea

Attendance and Representation:

Medical Practitioner: Not present and not represented

Medical Practitioner’s Representative: N/A

GMC Representative: Ms Eleanor Fry, Counsel

Attendance of Press / Public In accordance with Rule 41 of the General Medical Council (Fitness to Practise) Rules 2004 the hearing was held in public.

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Overarching Objective Throughout the decision making process the tribunal has borne in mind the statutory overarching objective as set out in s1 Medical Act 1983 (the 1983 Act) to protect, promote and maintain the health, safety and well-being of the public, to promote and maintain public confidence in the medical profession, and to promote and maintain proper professional standards and conduct for members of that profession. Determination on Facts - 23/01/2020 Background 1. Dr Lewis qualified in 1971 with an MB BCh from Ains Shams University, Egypt, and after receiving full registration to practise with the GMC obtained his LRCP, LRCS (Edinburgh) and LRCPS (Glasgow). He also, subsequently acquired MRCP (Ireland). Some years prior to the events which are the subject of the hearing, Dr Lewis undertook a variety of clinical positions in UK hospitals including senior roles in Rheumatology and Consultant roles in Geriatric Care and General Medicine. In May 1998 Dr Lewis commenced as a General Practitioner at St Mark’s Medical Centre, Ealing, London, where he remained until his retirement from General Practice in September 2018. At the time of the events Dr Lewis was practising as a Senior General Practitioner and private medical consultant at two locations: St Mark’s Medical Centre in Ealing, and 117a Harley Street, London. 2. The allegation that has led to Dr Lewis’ hearing can be summarised as that between November 2013 and October 2016 he inappropriately prescribed medication to a number of patients without having the necessary specialist expertise and/or entering into appropriate shared care agreements. The circumstances of the prescribing were unusual. The prescriptions were written for patients overseas via a pharmacy in the UK. 3. It is alleged that Dr Lewis failed to provide adequate advice to the patients for whom prescriptions were written and failed to make appropriate and adequate clinical records. It is also alleged that these failings amount to misconduct on the part of Dr Lewis. 4. On 20 January 2017 the Medicine and Healthcare products Regulatory Agency (‘MHRA’) and the General Pharmaceutical Council (‘GPhC’) conducted a joint inspection at Tweens Pharmacy, Bushy, Hertfordshire. The reason for this inspection was that there were concerns regarding the high volume of medicines being purchased by the pharmacy from wholesale dealers. During the inspection a ring binder was found which contained 140 private prescriptions, variously signed by one of three doctors. One of these doctors was Dr Lewis.

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5. Dr Lewis had signed a large number of private prescriptions between November 2013 and October 2016 for patients living outside the UK in places as diverse as Egypt, Belgium, Sri Lanka, Germany, USA, China, Kuwait and Poland. The drugs he prescribed, which are included in the sample allegations are Sprycel, Tysabri, Remicade, Celsentri, Truvada Prezista, Trizivir, Eviplera, Atripla and Viread. In each case the prescriptions were for medication which would be administered for a significant period of time. These drugs are used in highly specialised treatment settings for conditions which include Leukaemia, Multiple Sclerosis, and HIV therapy. Their prescription is generally to be found in a secondary or tertiary care environment. 6. Concerns were raised with the GMC on 29 June 2018 by Mr B, the MHRA Investigator. The Outcome of Applications Made during the Facts Stage 7. The Tribunal accepted the application made by Ms Fry, Counsel, on behalf of the GMC, that notice of this hearing had been properly served on Dr Lewis in accordance with Rule 31 and 40 of the General Medical Council (‘GMC’) (Fitness to Practise) Rules 2004, as amended (‘the Rules’). Full details of this decision can be found at Annex A. 8. The Tribunal also accepted the application made by Ms Fry, on behalf of the GMC, that Dr Lewis has voluntarily absented himself from these proceedings and to proceed with the hearing in Dr Lewis’ absence, pursuant to Rule 31 of the Rules. Full details of this decision can be found at Annex A. The Allegation and the Doctor’s Response 9. The Allegation made against Dr Lewis is as follows:

That being registered under the Medical Act 1983 (as amended):

1. You issued the prescriptions as set out in Schedules 1 to 10 and you:

a. failed to:

i. make adequate checks to confirm the identity of the patients, in

that you did not ensure that registration measures had been

appropriately taken; To be determined

ii. provide adequate safety netting advice, in that you did not

advise the patients of:

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1. the major side effects of the medication; To be

determined

2. how the major side effects of the medication manifest; To

be determined

iii. make an appropriate and adequate record of the:

1. identity checks of the patients seen; To be determined

2. diagnosis; To be determined

3. type of medication prescribed; To be determined

4. quantity of medication prescribed; To be determined

5. length of intended treatment; To be determined

6. monitoring requirements; To be determined

within the patients’ medical records;

iv. put monitoring processes in place; To be determined

b. inappropriately prescribed the medication without having:

i. the necessary specialist expertise; To be determined

ii. shared care agreements in place. To be determined

2. You issued the prescriptions as set out in Schedule 1 and you:

a. failed to adequately assess the patients prior to authorising the prescriptions, in that you prescribed the medication without access to the patients’ blood results; To be determined

b. inappropriately prescribed the medication without using a prescription proforma; To be determined

c. failed to specify the:

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i. intended stop and start date; To be determined

ii. duration; To be determined

of the treatment.

3. You issued the prescriptions as set out in Schedule 2 and you:

a. inappropriately prescribed the medication without full resuscitation facilities being immediately available; To be determined

b. failed to specify the patients’ addresses. To be determined

4. You issued the prescription as set out in Schedule 3 and you:

a. inappropriately prescribed the medication without:

i. monitoring Patient A for infection:

1. before; To be determined

2. during; To be determined

3. for six months after; To be determined

treatment;

ii. resuscitation equipment being available for immediate use after infusion; To be determined

iii. monitoring Patient A for symptoms of delayed hypersensitivity if re-administered after a prolonged period; To be determined

b. failed to:

i. refer Patient A for further tests; To be determined

ii. specify Patient A’s address. To be determined

5. You issued the prescription as set out in Schedule 7 and you failed to specify a clear regime for the medication. To be determined

6. You issued the prescription as set out in Schedule 8 and you failed to include Patient C’s full address. To be determined

7. You issued the prescription to Patient D as set out in Schedule 9 and you failed to include Patient D’s full address. To be determined

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And that by reason of the matters set out above your fitness to practise is impaired because of your misconduct. To be determined Factual Witness Evidence 10. The Tribunal received evidence on behalf of the GMC in the form of a witness statement from the following witness who was not called to give oral evidence, albeit he was available by telephone if required:

• Mr B, Investigator in the Enforcement Team of the MHRA. 11. Mr B’s evidence was confined to the circumstances in which the prescriptions written by Dr Lewis were identified. It did not touch the prescribing practices which form the subject matter of the allegations. Expert Witness Evidence 12. The Tribunal also received evidence from two expert witnesses. 13. Dr E, a General Practitioner of ten years’ experience who practises in the field of Digital Medicine and specialises in providing online consultations. Dr E has created online consultation proformas and algorithms in Men’s Health, Women’s Health, and Sexual & Reproductive Health and helped to develop an online sexual health service with Chelsea & Westminster NHS Trust. Dr E also has experience in providing Travel and Occupational Health advice online. 14. Dr E gave oral evidence to the Tribunal. He had previously provided a written report dated 12 October 2018, and a supplemental report dated 18 November 2019. 15. Dr E assisted the Tribunal in understanding the requirements and standards of care expected of a General Practitioner in prescribing medications, and the application of these principles in a private practice prescribing via a consultant’s referral letter. The Tribunal found Dr E to be a careful and authoritative witness. 16. Dr F, a consultant in haemato-oncology and stem cell transplantation who has prescribed chemotherapy since 1988 and trains doctors on prescribing chemotherapy. 17. Dr F gave oral evidence to the Tribunal. She had also provided a written report dated 30 October 2019. Dr F assisted the Tribunal in understanding the correct practices in the prescription and use of Sprycel, a highly specialised and relatively recently developed medication used in the treatment of Leukaemia. She provided her opinion in relation to the professional standards to be expected in connection with the prescription of this particular medication. The Tribunal also found her to be a careful and authoritative witness.

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Documentary Evidence 18. The Tribunal had regard to the documentary evidence provided by the parties. This evidence included, but was not limited to:

• Letter and witness statement from Bristol-Myers Squibb, dated 09 May 2017; • Email from Mr G (MHRA) to GMC, dated 07 August 2017;

• Private prescriptions signed by Dr Lewis, various dates; • Email notification and work details from Dr Lewis, dated 30 July 2018; • Dr Lewis’ CV, undated; • Interim Orders Tribunal transcript (redacted), dated 30 July 2018, and; • Telephone note between GMC and Dr Lewis, dated 28 October 2019.

The Tribunal’s Approach 19. In reaching its decision on facts, the Tribunal has borne in mind that the burden of proof rests on the GMC and it is for the GMC to prove the Allegation. Dr Lewis does not need to prove anything. The standard of proof is that applicable to civil proceedings, namely the balance of probabilities, i.e. whether it is more likely than not that the events occurred. 20. The absence of Dr Lewis from these proceedings is a neutral matter and no adverse inference is drawn from his non-attendance. The case is to be considered entirely on the evidence before the Tribunal. Adverse inferences may, however, be drawn from a failure to provide any of the relevant documentation, medical records or explanation of events as requested by the GMC during its investigation. Ms Fry, in her submissions, referred the Tribunal to Rule 16(A) of the General Medical Council (‘GMC’) (Fitness to Practise) Rules 2004, as amended (‘the Rules’) which enable the Tribunal to draw adverse inferences from a failure to comply with a direction issued by the Case Manager. 21. In the present case the Listings Instructions directed each party to disclose documentary evidence, including relevant medical records by 20 December 2019. That direction was given at a telephone conference on 12 August 2019. On 20 November 2019 a Case Manager had directed that Dr Lewis disclose to the GMC any document relating to the allegation upon which he intended to rely. Ms Fry stated that Dr Lewis had failed to disclose any clinical records in relation to the patients for whom these prescriptions were written and she invited the Tribunal to draw an adverse inference from that failure. 22. The Tribunal has taken into account such observations as there have been from Dr Lewis in relation to the subject matter of these proceedings. At an earlier Interim Orders Hearing it was said on behalf of Dr Lewis that he “wrote prescriptions for patients resident outside the UK on behalf of a pharmacy, via a letter from a consultant; in 30%

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of the cases the patient was not present.” It was emphasised that Dr Lewis had acted in “good faith” and that he had not sought to deceive anyone. It was said that he had concluded this work in 2016. 23. In a subsequent telephone conversation on 28 October 2019 with a member of the MPTS staff Dr Lewis is recorded as having said that he would speak to the home consultant and then give the patient the medication. He is also recorded as having said that he saw most of these patients and had experience with all of the drugs. The Tribunal noted these observations and reminded itself that they were not given under oath or affirmation and have not been tested in cross-examination. Nonetheless, the Tribunal bore them in mind when considering the evidence it heard. 24. As previously noted, the witness statement of Mr B is not concerned with prescribing practice. Prescribing practice generally is the subject of Dr E’s report and oral evidence. Prescribing practice in relation to Sprycel is the subject of Dr F’s report and oral evidence. The Tribunal’s Analysis of the Evidence and Findings 25. The Tribunal has considered each outstanding paragraph of the Allegation separately and has evaluated the evidence in order to make its findings on the facts. 26. Ms Fry told the Tribunal that the specific allegations were samples of Dr Lewis’ practice in relation to the drugs specified in the schedules. In its consideration of the evidence the Tribunal confined itself to the matters set out in the allegations. Paragraph 1 1(a)(i) 27. There was no evidence before the Tribunal to indicate that any identity checks or registration process occurred. Ms Fry submitted that minimum expectations in this regard are that a patient’s name, address and date of birth should be recorded, identifying the patient as registered with Dr Lewis. 28. In his supplemental report Dr E stated the following in regard to the specific circumstances of the case:

“The circumstance described in the question is highly unusual. A reasonably competent General Practitioner should be prescribing on a ‘needs-basis’ for the patient, in their best interest, rather than prescribing for pharmacies, via a consultant’s referral letter. The patient should have registered with the doctor’s private practice and medical notes kept.”

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29. As noted, Dr Lewis has failed to provide any clinical records or other documentation in relation to any of the patients for whom prescriptions were written. The Tribunal has drawn an adverse inference from this failure and has therefore concluded that no appropriate registration measures were taken. The Tribunal therefore finds paragraph 1(a)(i) proved. 1(a)(ii) 30. Both expert witnesses emphasised the importance of safety netting advice being provided in connection with the prescriptions which Dr Lewis was writing. Their concerns arose from the fact that Sprycel and the other medications were specialised forms of treatment applicable in secondary and tertiary care settings. The Tribunal was particularly mindful of the evidence of both expert witnesses regarding the types of prescriptions Dr Lewis had prescribed, namely specialist medications used for secondary or tertiary care, often with specialised treatment pathways requiring an adequate level of expertise. 31. By way of example, Dr E commented in relation to the prescription of Remicade that:

“Given that this medication should be initiated by a specialist, a HIV consultant would be best placed to advise on appropriate safety-netting advice when starting this medication. Patients should be made aware of the major side effects of the medication and how they manifest, as well as the HIV-related conditions to look out for. Examples of side effects that the patient may be made aware of are: abdominal pain, extreme tiredness, joint pains, cough, abnormal bleeding, cough, diarrhoea, dizziness, shortness of breath, fever, headache, insomnia, muscle pain, rashes and vomiting. An online prescriber should make the patient aware of possible side effects to look out for ‘red flags’. If basic safety netting was not carried out, in my opinion, this would fall seriously below the standard expected of an online prescriber. Safety netting helps to ensure that the patient with concerning symptoms or medication side-effects know when and how to access further advice and can be re-evaluated in a timely and appropriate manner.”

32. Dr Lewis has not provided any documents to suggest that safety netting advice in relation to the major side effects of the medications was provided by him. The Tribunal has drawn an adverse inference from his failure to do so, and accordingly finds this paragraph of the allegation proved. 1(a)(iii) 33. In considering this paragraph of the allegation, the Tribunal was mindful of paragraphs 19 and 21 of Good Medical Practice (2013 edition) (‘GMP’), which state:

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19. Documents you make (including clinical records) to formally record your work must be clear, accurate and legible. You should make records at the same time as the events you are recording or as soon as possible afterwards. … 21. Clinical records should include:

a. relevant clinical findings b. the decisions made and actions agreed, and who is making the decisions and agreeing the actions c. the information given to patients d. any drugs prescribed or other investigation or treatment e. who is making the record and when.

34. No evidence of any clinical records evidencing any of the matters set out above was provided by Dr Lewis. In the absence of any such records the Tribunal has drawn an adverse inference and concluded that it is probable that no such medical records exist and none of these matters were recorded. 35. The Tribunal therefore determined that this paragraph of the allegation is proved. 1(a)(iv) 36. In his report, Dr E made reference to the “GMC Ethical Guidance for Doctors, Prescribing and Managing Medicine and Devices”, which states at paragraph 66:

“If you prescribe for patients who are overseas, you should consider how you or local healthcare professionals will monitor their condition. You should also have regard to differences in a product’s licensed name, indications and recommended dosage regimen. You may also need to consider:

a. MHRA guidance on import/export requirements and safety of delivery, b. whether you will need additional indemnity cover c. whether you will need to be registered with a regulatory body in the country in which the prescribed medicines are to be dispensed.”

37. The Tribunal was satisfied that the medicines prescribed by Dr Lewis required monitoring processes to be in place. For example, Dr E stated in his report:

“HIV medications and biologic medications require regular monitoring and shared-care agreements in place if to be prescribed by anyone other than the specialist in that field. If measures have not been taken to arrange for regular

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monitoring or engaging local healthcare practitioners, this would fall seriously below the standard expected of a reasonably competent online prescriber.”

38. The Tribunal accepted the submission of Ms Fry that online prescribing, Dr E’s field of expertise, is analogous to remote prescribing as undertaken by Dr Lewis. Whilst there are differences in the two approaches and the Tribunal carefully considered the weight to apply to Dr E’s evidence on these matters, it concluded that the expectations for monitoring following the prescribing of these specialist medicines was applicable to this paragraph of the allegation. 39. For reasons which are set out below, at paragraph 46 in particular, the Tribunal did not consider that Dr Lewis was a specialist in any of the fields for which these medications were prescribed. 40. No evidence of any monitoring or shared care agreements was provided for the patients for whom these prescriptions were written. 41. Given the nature of the medicines prescribed and the expert advice on these matters, the Tribunal determined that such monitoring was necessary and on the balance of probabilities did not occur. It therefore found this paragraph of the allegation proved. 1(b)(i) 42. The Tribunal carefully considered the evidence of the expert witnesses on this matter, who emphasised that due to the nature of the drugs prescribed and the administration routes required, it was very unusual for a GP to be prescribing this medication. If such a prescription by a GP did occur it would need to be within the context of appropriate shared care agreements and multi-disciplinary engagement. 43. In her report, Dr F stated the following in regard to the prescription of Sprycel:

“It is a highly specific targeted anti-cancer medicine and should only be prescribed by haemato-oncologists who are trained to manage this group of patients and prescribe their treatment.”

44. Dr F’s report went on to state:

“Dr Lewis is a general practitioner. Dr Lewis has not provided any evidence to show that he has undertaken any training in haematology and is he is [sic] therefore not qualified to prescribe chemotherapy or any anti-cancer drugs, including dasatinib [Sprycel]. …

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There is no evidence provided that he saw any of these patients. In writing these prescriptions Dr Lewis’s standard was seriously below the standard of care expected of a reasonably competent registrar who had not completed his training in haematology. Having worked in the UK he should have been aware that chemotherapy and anti-cancer drugs for patients with cancer are prescribed by haemato-oncologist or oncologists. The only exceptions to this are dermatologists and rheumatologists who may sometimes prescribe some anticancer medication for patients with immune disorders (such as rituximab, oral methotrexate or thalidomide, but they too have training and guidelines to follow).”

45. At the request of the Tribunal Dr F reviewed the CV provided by Dr Lewis in light of the allegations, and confirmed that it contained no training or professional positions that would demonstrate Dr Lewis’ competency or knowledge in these areas. She also confirmed that Sprycel had only been used within the last ten to twelve years. 46. Dr Lewis’ CV showed no relevant training or specialisation in the areas of expertise required for the appropriate prescription, administration or follow-up care for the specialist medicines he prescribed. Further, there was no evidence that he has undertaken any secondary care work since the 1990’s, more than two decades ago. Such roles, where they did occur, appear to have been short-term contracts or on a locum basis. 47. The Tribunal also considered the advice of Dr E that the types of medicines included in the allegations would usually not be prescribed by a GP, and where this did occur it would need to be under the necessary expert supervision and protocols. 48. Dr E’s report stated:

“Aspects of prescribing that were seriously below the standard expected of a reasonably competent General Practitioner are also still relevant. Prescribing MS infusion medications, biologics, HIV medications, oral chemotherapy and pulmonary hypertension medications remotely without shared care agreements and monitoring processes in place or by a doctor without adequate training in the respected fields is not safe in my opinion. If these processes and expertise are not present, this would fall seriously below the standard expected of a General Practitioner.”

49. In light of the evidence provided by the experts, the Tribunal determined that Dr Lewis had inappropriately prescribed these medicines without the necessary expertise. It therefore found this paragraph of the allegation proved.

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1(b)(ii) 50. As was the case for post-prescription monitoring processes, there was no evidence put before the Tribunal to demonstrate that any shared care agreements were arranged or in place. Dr Lewis did not make any medical records available, despite requests, and so on the balance of probabilities the Tribunal concluded that such care agreements did not exist. 51. The Tribunal therefore determined this paragraph of the allegation as proved. Paragraph 2 – This allegation relates to the prescribing of Sprycel, which is a specialist chemotherapy medication used in the treatment of Leukaemia. 2(a) 52. In concluding that Dr Lewis’ overall standard of care was seriously below the standard to be expected when prescribing Sprycel, Dr F relied in part upon the following:

“As no medical records are available there is no evidence that he saw these patients or that physical assessments and blood tests were taken prior to prescriptions being issued.”

53. The Tribunal accepted her evidence that given the nature of the medication and the specialist nature of the treatment, Dr Lewis had a duty to access the patient’s blood results. 54. No evidence was provided to the Tribunal to demonstrate that such arrangements were in place. Whilst such blood results may have been in a consultant letter, Dr Lewis provided no testimony or evidence to support this possibility. Given his lack of cooperation on the matter the Tribunal took the adverse inference that on the balance of probabilities no such records exist and no such checks occurred. 55. The Tribunal found this paragraph of the allegation proved accordingly. 2(b)&(c) 56. Whilst Dr F did not comment on the use of proformas specifically in her report or evidence, in his written report, Dr E stated the following in relation to the prescription of Sprycel:

“Several advanced criteria would need to be fulfilled to safely prescribe Sprycel. These are described in in Position Statement on the Care of Patients

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Receiving Oral Chemotherapy. British Oncology Pharmacy Association (2004); Pharm J 272, 422423: • “Electronic systems, or prescription proformas or templates, similar to those for parenteral chemotherapy should be used. • Prescriptions must state clearly for each course of treatment, the dose, frequency of administration, intended start date, duration of treatment and, where relevant, the intended stop date. …

In this case, a prescription proforma was not used, the number of tablets to be dispensed has not been included and there is no stop / start date or duration of treatment specified. In my opinion, this would fall seriously below the standard expected of an online prescriber.”

57. In his supplementary report Dr E went on to state:

“In cases of Sprycel prescribing, prescription proformas were not used. The intended start date of the therapy has not been stated on any of the prescriptions. It appears that the medication was prescribed in ‘good faith’ rather than in the context of written shared care protocols, though this is not clear.”

58. The Tribunal reiterated that online prescribing can be considered analogous to Dr Lewis prescribing remotely, but that caution must be applied to the weight attributed to the evidence of Dr E in these matters. 59. Given the specialist nature of the medicine and treatment in relation to Sprycel, and that the requirements outlined by Dr E relate to the safe use and monitoring of these treatments, rather than the online prescribing of them specifically, the Tribunal attributed significant weight to his evidence. 60. The importance of strict practices in the prescribing and administration of Sprycel, together with shared care arrangements and record keeping was also supported by the evidence of Dr F. The Tribunal therefore accepted the evidence of Dr E that such proformas should have been used. 61. The Tribunal considered whether the prescription regimes as referenced on the prescription sheets could be considered as adequate in fulfilling the requirement to specify the intended duration and start and stop dates of the medication. 62. It concluded that whilst these could be considered indicative of the treatment dates and duration, they are unclear and do not explicitly include the relevant

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information. This is particularly true given the importance of accurate and specialist supervision in the use of Sprycel to treat relevant conditions. 63. The Tribunal therefore found this paragraph of the allegation proved. Paragraph 3 – This relates to the prescription of Tysabri, a specialist medication used in the treatment of Multiple Sclerosis by way of intravenous infusion. 3(a) 64. In his expert report, Dr E refers to the BNF guidance, which states:

“Highly active relapsing-remitting multiple sclerosis despite treatment with interferon beta or glatiramer acetate, or those patients with rapidly evolving severe relapsing-remitting multiple sclerosis (initiated under specialist supervision). Important safety information: For all ANTI-LYMPHOCYTE MONOCLONAL ANTIBODIES: All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.”

65. Dr E went on to state that:

“The BNF states that “all anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist in an environment where full resuscitation facilities are immediately available”. In my opinion, it would be rare for the neurologist to request the GP to prescribe this medication for administration by the neurologist. In my opinion, given these prescribing guidelines, monitoring requirements and the guidelines mentioned above, the prescribing of this medication would fall seriously below the standard expected of a competent GP. It would be difficult to have safeguards in place to remotely prescribe this medication.”

66. The Tribunal accepted the advice of Dr E that there is a requirement to ensure availability of resuscitation equipment and that this medication requires administration by a practitioner with suitable expertise, and is not self-administered. There were no records or evidence to demonstrate that Dr Lewis had made such provisions or resuscitation equipment was available or satisfied himself that resuscitation equipment was available. 67. The Tribunal accepted Dr E’s evidence and determined that no such provisions were in place and that no checks in relation to this had been made. 68. The Tribunal therefore found this paragraph proved.

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3(b) 69. The Tribunal noted that Dr Lewis had written “C/O [care of] Dr Lewis” and a partial address for St Mark’s Medical Centre on the prescriptions this paragraph of the allegation relates to. 70. The Tribunal was mindful that there may be appropriate reasons for addressing a patient’s prescriptions to the care of a medical institution or practitioner, particularly where the medication is specialised and requires administration by a practitioner with the necessary expertise. 71. The Tribunal also considered the evidence of Dr E on the matter, who stated that the patient’s address should have been included and not to do so was a failure on the part of Dr Lewis. However, the advice of Dr E was provided in reference to online prescribing and not remote prescribing, as was undertaken with some of Dr Lewis’ patients. 72. Whilst accepting the submissions by Ms Fry, Counsel, on behalf of the GMC, that online prescribing is analogous to remote prescribing, it emphasised that there are some differences and therefore the applicability of Dr E’s assertions in this regard must be carefully considered. 73. Moreover, in the specific circumstances of this case, the Tribunal is unable to determine whether Dr Lewis met with this patient in person or made the prescription on a remote basis via a third party consultant. At the MPTS Interim Orders Tribunal on 30 July 2018 Dr Lewis’ legal representative, XXX, described the detail of Dr Lewis’ prescribing practice. He stated that Dr Lewis wrote prescriptions for patients resident outside the UK on behalf of a pharmacy, via a letter from a consultant, and that in 30% of the cases the patient was not present. 74. Whilst uncertainties remain over the specifics of the patient, consultation process and localities, the Tribunal determined that Dr Lewis had failed to specify the patient’s address and accordingly found this paragraph of the allegation proved. Paragraph 4 – This relates to the prescription of Remicade, a specialist medication used for the treatment of autoimmune disease by way of intravenous infusion. 4(a)(i)-(iii) 75. In considering this paragraph of the allegation, the Tribunal considered the evidence of GMC expert witness Dr E in relation to Patient A. His report states:

“With the information provided thus far and without access to the medical records, I am unable to comment on whether the patient was referred for any tests or investigations prior to prescribing the medicine.

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… Referral for tests / investigations are necessary for the monitoring of the patient will be dependent on the status of the patient, following latest guidelines and shared care protocols. For example, when prescribing this medication for Rheumatoid Arthritis, blood tests are recommended before each infusion. It is unclear whether a shared-care protocol has been followed and if any tests have been arranged. If a shared-care agreement had not been followed and tests not arranged, in my opinion, this would fall seriously below the standard expected of a competent GP.”

76. Dr E’s report also states:

“In addition, the patient needs to be monitored for infection before, during, and for 6 months after treatment. All patients should be observed carefully for 1-2 hours after infusion and resuscitation equipment should be available forimmediate use(risk of hypersensitivity reactions). Patients should be monitored for symptoms of delayed hypersensitivity if re-administered after a prolonged period. (BNF) In my opinion, this [failure to do so] would therefore fall seriously below the standards expected of a competent GP.”

77. The Tribunal accepted the evidence of Dr E on this matter, and concluded that these were requirements of Dr Lewis, who had a duty to ensure adequate monitoring was in place. The Tribunal was not persuaded that Dr Lewis would necessarily be required to carry out such monitoring himself, but agreed that such monitoring needed to be in place and it was Dr Lewis’ duty to ensure such arrangements were present and adequate as part of the prescription process. 78. In the absence of any records demonstrating that Dr Lewis undertook such actions and in light of the fact that he failed to comply with requests to produce these, or any related documents, the Tribunal drew an adverse inference and determined that no such arrangements or recording of said arrangements took place. 79. The Tribunal therefore found this paragraph of the allegation proved. 4(b) 80. On the prescription provided to the Tribunal there is no address for the patient, instead Dr Lewis has written:

“C/O [care of] Dr N Lewis, St Mark’s Medical Centre, Ealing W5”

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81. Dr Lewis did not include the patient’s address. There is no evidence that he was the treating physician for the patient, which could provide some reason for the inclusion of the address for his clinic. Because the Tribunal found that the patient’s home address was not included the Tribunal found this paragraph of the allegation proved. Paragraph 5 82. In considering this paragraph of the allegation, the Tribunal considered the opinion of expert witness Dr E, who states in his report:

“The regime is not clear. Written on the prescription on subsequent lines are “60 tablets” followed by “one tablet twice daily”, followed by “pack of”, followed by “3 packs 180 tablets””.

83. The Tribunal noted that the note does refer to a pack size of 60 tablets, and also that the prescription is for three packs totalling 180 tablets. 84. The Tribunal was of the opinion that the note makes the regime clear, with one tablet to be taken twice daily, with three packs of 60 tablets and a total course of 180 tablets, or 90 days. 85. The allegation does not ask the Tribunal to determine whether the treatment regime is correct, but rather whether a clear regime was specified. Given this fact, and that Dr E has not elaborated or provided evidence on why he considers this note insufficient or unclear, the Tribunal determined that Dr Lewis did not fail to specify a clear regime for the medicine. 86. Accordingly, the Tribunal found this paragraph of the allegation not proved. Paragraph 6 87. Following a Tribunal request the unredacted address included on the prescription written by Dr Lewis was produced. During his oral evidence, Dr E confirmed that he had only been provided with the redacted versions of these documents and had produced his report on this basis. Under these circumstances the Tribunal was unable to rely on the expert report of Dr E when reaching its determination on this paragraph. 88. During its deliberation, the Tribunal noted that the patient’s address may not necessarily be a personal, home address as the patient may be under the care of a practitioner or clinic. In certain circumstances this could be considered appropriate, and without further evidence before it the Tribunal could not conclude that the address of an outpatient clinic amounted to a failure to include the patient’s address.

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89. The Tribunal did, however, conclude that whether a home or clinical address was appropriate, it should be included clearly and in full and this was not the case for the address referred to in paragraph 6 of the allegation, which appears incomplete. 90. The Tribunal concluded that the address provided by Dr Lewis was insufficient to ensure the location is clearly identifiable and any correspondence would be correctly processed or received. It therefore determined that Dr Lewis did not include the full address and found this paragraph of the allegation proved. Paragraph 7 91. For the same rationale as outlined for paragraph 6 the Tribunal concluded that whether the address was correct and appropriate could not be determined from the evidence before it, but that the address was clearly incomplete and insufficient. Accordingly, it found this paragraph of the allegation proved. The Tribunal’s Overall Determination on the Facts 92. The Tribunal has determined the facts as follows:

That being registered under the Medical Act 1983 (as amended):

1. You issued the prescriptions as set out in Schedules 1 to 10 and you:

a. failed to:

i. make adequate checks to confirm the identity of the patients, in

that you did not ensure that registration measures had been

appropriately taken; Determined and found proved

ii. provide adequate safety netting advice, in that you did not

advise the patients of:

1. the major side effects of the medication;

Determined and found proved

2. how the major side effects of the medication manifest;

Determined and found proved

iii. make an appropriate and adequate record of the:

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1. identity checks of the patients seen;

Determined and found proved

2. diagnosis;

Determined and found proved

3. type of medication prescribed;

Determined and found proved

4. quantity of medication prescribed;

Determined and found proved

5. length of intended treatment;

Determined and found proved

6. monitoring requirements;

Determined and found proved

within the patients’ medical records;

iv. put monitoring processes in place;

Determined and found proved

b. inappropriately prescribed the medication without having:

i. the necessary specialist expertise;

Determined and found proved

ii. shared care agreements in place.

Determined and found proved

2. You issued the prescriptions as set out in Schedule 1 and you:

a. failed to adequately assess the patients prior to authorising the

prescriptions, in that you prescribed the medication without access to

the patients’ blood results;

Determined and found proved

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b. inappropriately prescribed the medication without using a prescription

proforma; Determined and found proved

c. failed to specify the:

i. intended stop and start date;

Determined and found proved

ii. duration;

Determined and found proved

of the treatment.

3. You issued the prescriptions as set out in Schedule 2 and you:

a. inappropriately prescribed the medication without full resuscitation

facilities being immediately available;

Determined and found proved

b. failed to specify the patients’ addresses.

Determined and found proved

4. You issued the prescription as set out in Schedule 3 and you:

a. inappropriately prescribed the medication without:

i. monitoring Patient A for infection:

1. before;

Determined and found proved

2. during;

Determined and found proved

3. for six months after;

Determined and found proved

treatment;

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ii. resuscitation equipment being available for immediate use after

infusion;

Determined and found proved

iii. monitoring Patient A for symptoms of delayed hypersensitivity if

re-administered after a prolonged period;

Determined and found proved

b. failed to:

i. refer Patient A for further tests;

Determined and found proved

ii. specify Patient A’s address.

Determined and found proved

5. You issued the prescription as set out in Schedule 7 and you failed to specify

a clear regime for the medication.

Not proved

6. You issued the prescription as set out in Schedule 8 and you failed to include

Patient C’s full address.

Determined and found proved

7. You issued the prescription to Patient D as set out in Schedule 9 and you

failed to include Patient D’s full address.

Determined and found proved

And that by reason of the matters set out above your fitness to practise is impaired

because of your misconduct. To be determined

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Determination on Impairment - 24/01/2020 1. The Tribunal now has to decide in accordance with Rule 17(2)(l) of the Rules whether, on the basis of the facts which it has found proved, Dr Lewis’ fitness to practise is impaired by reason of misconduct. The Evidence 2. The Tribunal has taken into account all the evidence received during the facts stage of the hearing, both oral and documentary. Submissions 3. On behalf of the GMC, Ms Fry, Counsel, submitted that the nature of Dr Lewis’ failures represent multiple breaches of Good Medical Practice (2013 edition) (‘GMP’), demonstrating that patients and patient safety were not the primary concern of Dr Lewis. 4. Ms Fry submitted that Dr Lewis’ position at the Interim Orders Tribunal on 30 July 2018 appeared to have been that he did not see approximately a third of the patients for whom he prescribed medication. She submitted that the Tribunal ought to conclude that Dr Lewis did not have adequate knowledge of the patients for whom he was prescribing specialist medication. This is supported by the lack of any records or planned monitoring to demonstrate that proper diligence was exercised, and adequate safeguards put in place, by Dr Lewis. 5. Ms Fry also submitted that Dr Lewis’ prescribing of these medicines at all was inappropriate given his lack of relevant experience or qualifications. To prescribe in such circumstances whilst simultaneously failing to adhere to the necessary guidance and protocols put patient safety at risk. She submitted that Dr Lewis’ actions were reckless and amounted to serious and persistent misconduct. 6. Ms Fry also submitted that Dr Lewis’ fitness to practise remained impaired. She referred to Dr Lewis’ lack of cooperation with the GMC investigation and submitted that this raised serious questions about his level of insight. Although Dr Lewis has stated that he retired from NHS practice in September 2018 he has expressed an interest in possibly continuing to practise in a private setting. Ms Fry submitted that a finding of impairment was necessary in order to protect patients and to uphold the reputation of the profession. The Relevant Legal Principles 7. The Tribunal reminded itself that at this stage of proceedings, there is no burden or standard of proof and the question of impairment is a matter for the Tribunal’s judgement alone.

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8. In approaching this aspect of the case, the Tribunal was mindful of the two stage process to be adopted: first whether the facts as found proved amount to misconduct and, if so, whether the practitioner’s fitness to practise is currently impaired by reason of that misconduct. 9. There is no statutory definition of misconduct and it is for the Tribunal to apply its own judgement in determining this; the question is always whether the falling short of appropriate standards is sufficiently serious to justify a finding of misconduct. A practical, working definition of the term “misconduct” might be considered to be “a serious departure from generally accepted professional standards”. 10. If misconduct is established, the Tribunal must then determine whether Dr Lewis’ fitness to practise is impaired today, taking into account Dr Lewis’ conduct at the time of the events and any relevant matters which have occurred since those events. The Tribunal will form a view as to whether the misconduct is in principle remediable, whether it has been remedied and whether there is a likelihood of repetition. 11. The Tribunal had regard to the guidance of Dame Janet Smith in the Fifth Shipman Report and endorsed in CHRE v NMC and Paula Grant [2011] EWHC 297 Admin. A helpful approach is therefore to consider whether Dr Lewis’ fitness to practise is impaired in the sense that he:

a. ‘Has in the past acted and/or is liable in the future to act so as to put a patient or patients at unwarranted risk of harm; and/or

b. Has in the past or is liable in the future to bring the medical profession into disrepute; and/or

c. Has in the past breached or is liable to breach in the future one of the fundamental tenets of the medical profession; and/or d. Has in the past acted dishonestly and/or is liable to act dishonestly in the future.’

12. The Tribunal also reminded itself that, as stated in Grant, at paragraph 74:

“In determining whether a practitioner's fitness to practise is impaired by reason of misconduct, the relevant panel should generally consider not only whether the practitioner continues to present a risk to members of the public in his or her current role, but also whether the need to uphold proper professional standards and public confidence in the profession would be undermined if a finding of impairment were not made in the particular circumstances.”

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The Tribunal’s Determination on Impairment Misconduct 13. The Tribunal noted the multiple examples of failings and inappropriate prescribing behaviour by Dr Lewis, as set out in the expert witness reports. 14. An example in relation to the prescribing of Sprycel taken from Dr F’s report is set out below. Dr F, who gave oral evidence in this case, is a specialist in the treatment of leukaemia. In her report she wrote the following:

“Dr Lewis is a general practitioner. Dr Lewis has not provided any evidence to show that he has undertaken any training in haematology and is he is therefore not qualified to prescribe chemotherapy or any anti-cancer drugs, including dasatinib. Between November 2013 and October 2016 Dr Lewis signed private prescriptions for Sprycel. All the patients who obtained the prescriptions lived outside the UK – Egypt, Belgium, Sri Lanka, Germany, USA, France, Kuwait and Poland. There is no evidence provided that he saw any of these patients. In writing these prescriptions Dr Lewis’s standard was seriously below the standard of care expected of a reasonably competent registrar who had not completed his training in haematology. Having worked in the UK he should have been aware that chemotherapy and anti-cancer drugs for patients with cancer are prescribed by haemato-oncologist or oncologists. The only exceptions to this are dermatologists and rheumatologists who may sometimes prescribe some anticancer medication for patients with immune disorders (such as rituximab, oral methotrexate or thalidomide, but they too have training and guidelines to follow). To have prescribed any prescription for a patient with leukaemia without being qualified or trained to, showed total disregard for the safety of the patient and was reckless. In addition, the prescriptions that Dr Lewis prescribed were for 3 months in duration. When we prescribe Sprycel for patients with CML (chronic myeloid leukaemia) or ALL (acute lymphoblastic leukaemia) because of the side effects associated with the drug, it is usually prescribed for a maximum of 30 days and they then return for assessment and blood tests. To issue prescriptions for periods of 3 months was seriously below the standard of care expected when prescribing Sprycel, as regular monitoring for side effects and response to treatment (usually done monthly) with blood tests and physical examination were not carried out.”

15. In his supplemental report Dr E, an experienced general practitioner who gave oral evidence in this case, stated:

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“Aspects of prescribing that were seriously below the standard expected of a reasonably competent General Practitioner are also still relevant. Prescribing MS infusion medications, biologics, HIV medications, oral chemotherapy and pulmonary hypertension medications remotely without shared care agreements and monitoring processes in place or by a doctor without adequate training in the respected fields is not safe in my opinion. If these processes and expertise are not present, this would fall seriously below the standard expected of a General Practitioner. … In the cases of Tysabri, Revatio and Remicade, these all remain secondary care specialist medications and should be prescribed by the specialist, who would remain responsible for the ongoing monitoring and management of the patient. Remote prescribing of any infusion medication or pulmonary hypertension medication is out of scope of General Practice as it stands at present. Prescribing of these medications falls seriously below the standard expected of a General Practitioner in my opinion.”

16. In considering these aspects of the expert evidence, the Tribunal was mindful of paragraphs 16(a) & (f) of GMP, which state:

16. In providing clinical care you must: a. prescribe drugs or treatment, including repeat prescriptions,

only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs

f. check that the care or treatment you provide for each patient is

compatible with any other treatments the patient is receiving, including (where possible) self-prescribed over-the-counter medications.

17. In addition to the inappropriate prescribing of these specialist medicines, for which Dr Lewis did not have the necessary experience or qualifications, he failed to make adequate clinical records to support these prescriptions. On the evidence before it the Tribunal must conclude that no such records exist at all, making the failings in his record keeping significantly more serious in nature. 18. In considering this aspect of Dr Lewis’ actions the Tribunal were mindful of paragraphs 19 and 21 of GMP, which state:

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19. Documents you make (including clinical records) to formally record your work must be clear, accurate and legible. You should make records at the same time as the events you are recording or as soon as possible afterwards.

21. Clinical records should include:

a. relevant clinical findings

b. the decisions made and actions agreed, and who is making the decisions and agreeing the actions

c. the information given to patients

d. any drugs prescribed or other investigation or treatment

e. who is making the record and when. 19. In the absence of any evidence to the contrary, the Tribunal concluded that Dr Lewis failed to ensure that proper safeguards and shared care agreements were in place. The Tribunal determined that this failure to ensure suitable safety netting and monitoring following the prescription also breached GMP guidelines, in particular paragraph 45, which states:

45. When you do not provide your patients’ care yourself, for example

when you are off duty, or you delegate the care of a patient to a colleague, you must be satisfied that the person providing care has the appropriate qualifications, skills and experience to provide safe care for the patient

20. The Tribunal determined that Dr Lewis’ failures clearly amount to misconduct. The prescribing of Sprycel alone amounted to misconduct, and this was just one example of the specialist medicines inappropriately prescribed by Dr Lewis. He prescribed a range of such drugs with no apparent safeguards. His failure to take any steps to see that these medicines, which he should not have prescribed anyway, were administered and used correctly compounds his misconduct. 21. The Tribunal accepted the submission of Ms Fry that Dr Lewis’ behaviour was not an isolated incident but reflects a sustained pattern of behaviour over a number of years. This consistent repetition of inappropriately prescribing specialist medicines and failing to adhere to necessary guidelines when so doing represents, in the Tribunal’s assessment, misconduct. 22. The Tribunal has therefore concluded that Dr Lewis’ conduct fell so far short of the standards of conduct reasonably to be expected of a registered medical practitioner as to amount to misconduct.

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23. The Tribunal having determined that the facts found proved amounted to misconduct, went on to consider whether, as a result of that misconduct, Dr Lewis’ fitness to practise is currently impaired. 24. Whilst Dr Lewis has previously stated that he acted based on the instructions of consultants. The Tribunal received no evidence to support this. In any event, the Tribunal did not accept that this in any way absolved him of his own responsibilities as a practitioner. The Tribunal did not accept that Dr Lewis had put his patient’s interests first. His prescribing put his patients at risk. 25. This failure to put the patient’s welfare first breaches one of the fundamental tenets of the profession and the Tribunal considered this in light of paragraphs 1 and 31 of GMP:

1. Patients need good doctors. Good doctors make the care of their patients their first concern: they are competent, keep their knowledge and skills up to date, establish and maintain good relationships with patients and colleagues…

31. You must listen to patients, take account of their views, and respond

honestly to their questions. 26. The Tribunal is very concerned by the lack of insight demonstrated by Dr Lewis. In a telephone conversation which took place in October 2019 Dr Lewis is recorded as having maintained a position to the effect that he had done nothing wrong and that it was absolutely ridiculous for an expert to conclude that he was not good enough to write the prescriptions. 27. The expert evidence which the Tribunal heard from both Dr E and Dr F completely contradicts Dr Lewis’ position. In the Tribunal’s assessment Dr Lewis’ attitude indicates an ongoing risk to patient safety. 28. The Tribunal’s concern in relation to Dr Lewis’ level of insight is compounded by his lack of cooperation with the GMC investigation. The Tribunal reminded itself of paragraph 73 of GMP:

73. You must cooperate with formal inquiries and complaints procedures and must offer all relevant information while following the guidance in Confidentiality.

29. Dr Lewis has failed to supply any documentation to the GMC and has failed to engage constructively with these proceedings. 30. In these circumstances the Tribunal has concluded that the first three limbs of Dame Janet Smith’s helpful formulation are all engaged.

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31. Dr Lewis’ prescribing practice put patients at risk and his lack of insight gives rise to a risk of repetition. 32. His failure to put the interests of patients first was a breach of a fundamental tenet of the profession and he has shown no sign that he recognises this. 33. Further, the Tribunal considers that his failure to follow appropriate prescribing practices is likely to bring the profession into disrepute. 34. For these reasons the Tribunal finds that Dr Lewis’ current fitness to practise is impaired on the grounds that his conduct created a risk to patients and this conduct has not been remediated. 35. Further, the Tribunal finds that a reasonable and fully informed member of the public would be disturbed if a finding of impairment were not made in this case. Such a finding is necessary to uphold proper standards of conduct and behaviour and to maintain confidence in the profession and its regulation. 36. The Tribunal has therefore determined that Dr Lewis’ fitness to practise is impaired by reason of his misconduct. Determination on Sanction - 27/01/2020 1. Having determined that Dr Lewis’ fitness to practise is impaired by reason of misconduct, the Tribunal now has to decide in accordance with Rule 17(2)(n) of the Rules on the appropriate sanction, if any, to impose. The Evidence 2. The Tribunal has taken into account evidence received during the earlier stages of the hearing where relevant to reaching a decision on sanction. Submissions 3. On behalf of the GMC, Ms Fry submitted that Dr Lewis’ actions represent clear and multiple breaches of Good Medical Practice (2013 edition) (‘GMP’). These behaviours reflect an ongoing risk to both patient safety and public confidence in the profession, and a commensurate sanction is therefore required in order to protect the public and uphold the overarching objective. 4. Ms Fry submitted that the only proportionate response to the risks posed by Dr Lewis is the sanction of erasure from the medical register. Few, if any, mitigating factors are present in this case and there is an abundance of aggravating factors. No evidence

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has been submitted that demonstrates any reflection, remediation or an apology on the part of Dr Lewis and no insight into these serious failings is apparent. 5. Ms Fry submitted that during the telephone call with the GMC on 28 October 2019, Dr Lewis indicated that he believes he has done nothing wrong and his actions were both appropriate and justified. As such, there is no assurance that if Dr Lewis continues to practise he would work within his areas of competence and such behaviours as the Tribunal has found proved would not be repeated. 6. Ms Fry submitted that the unequivocal evidence of Dr F is that Dr Lewis’ actions were reckless and risked patient safety. In the light of Dr Lewis’ absence of insight and his failure to engage with these proceedings, any sanction less than erasure would fail to protect the public and would undermine the reputation of the profession. Ms Fry reminded the Tribunal that Dr Lewis is an experienced practitioner who might be expected to be fully aware of his responsibilities. 7. Ms Fry referred the Tribunal to the GMC Sanctions Guidance 2019 (“Sanctions Guidance”) and submitted that the sanction of suspension was not sufficient because of the seriousness of the breaches of GMP and the extent of the aggravating factors. The Tribunal’s Determination on Sanction 8. The Legally Qualified Chair of the Tribunal provided the following legal advice, which was agreed by Ms Fry, Counsel, on behalf of the GMC:

i) In reaching its decision the Tribunal must take into account the

Sanctions Guidance. If the Tribunal departs from the Guidance, the relevant paragraph should be referenced and reasons given for doing so;

ii) The purpose of sanction is not to be punitive although the sanction

imposed may have a punitive effect; iii) The Tribunal must apply the principle of proportionality; balancing the

doctor’s interests with the public interest; iv) The Tribunal must consider any relevant mitigating and aggravating

factors and address them within the context of the determination; v) The decision as to the appropriate sanction, if any, to impose is a

matter for the Tribunal exercising its own judgement. It must consider the least restrictive sanction first and then, if necessary, consider the other sanctions, taking into account the submissions that have been heard. The Tribunal must consider its determination on impairment and take those matters into account during its deliberations on sanction.

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9. The Tribunal then considered aggravating and mitigating factors. Aggravating Factors

• Lack of any insight with no reflection, attempts to remediate or apology; • Breaches of several principles of GMP guidance and a fundamental tenet of

the profession; • Multiple examples of breaches over a period of several years; • Dr Lewis is an experienced doctor who should have been fully aware of his

responsibilities; • A persistent failure to engage or cooperate with the GMC investigation or the

current proceedings. The extent of any constructive engagement by Dr Lewis with the concerns raised in relation to his practice appears to have been restricted to representation at a single Interim Orders hearing;

• A pattern of reckless behaviour and blatant disregard for patient safety; • A significant chance of repetition.

Mitigating Factors

• Dr Lewis claimed that he thought he was acting in the best interests of his patients;

• The Tribunal have not been told of any other disciplinary proceedings during the course of a lengthy career.

No action 10. The Tribunal decided that taking no action would fall well short of a proportionate sanction. It would not reflect the seriousness of Dr Lewis’ misconduct. 11. In addition, taking no action would not offer any mitigation of the ongoing risk to patient safety posed by Dr Lewis. Conditions 12. The Tribunal concluded that conditions would be neither proportionate nor workable in this case. 13. Dr Lewis’ failure to engage constructively following the initial Interim Orders Tribunal suggests a similar lack of constructive engagement would be likely if conditions were imposed. 14. The Tribunal also concluded that, even were conditions workable, they would not be a proportionate response to the misconduct of Dr Lewis.

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15. Dr Lewis’ actions were reckless and put patient safety at risk. The Tribunal concluded that a conditions of practice order would not reflect the seriousness of the shortcomings in Dr Lewis’ practice. 16. Public safety and the reputation of the profession would not be adequately upheld by the imposition of conditions. Suspension 17. The tribunal then went on to consider the sanction of suspension. 18. In doing so the Tribunal was mindful of paragraphs 92 and 93 of the Sanctions Guidance, which state:

92 Suspension will be an appropriate response to misconduct that is so serious that action must be taken to protect members of the public and maintain public confidence in the profession. A period of suspension will be appropriate for conduct that is serious but falls short of being fundamentally incompatible with continued registration (ie for which erasure is more likely to be the appropriate sanction because the tribunal considers that the doctor should not practise again either for public safety reasons or to protect the reputation of the profession).

93 Suspension may be appropriate, for example, where there may have

been acknowledgement of fault and where the tribunal is satisfied that the behaviour or incident is unlikely to be repeated. The tribunal may wish to see evidence that the doctor has taken steps to mitigate their actions (see paragraphs 24–49).

19. The Tribunal concluded that Dr Lewis’ actions were reckless, put patient safety at risk and that there is a significant chance of repetition. There has been no admission of fault from Dr Lewis. On the contrary, he has denied any wrongdoing and is recorded as having asserted that there was nothing inappropriate in his prescribing practice. Further he has failed to engage with the current proceedings or provide any of the documentation or records requested by the GMC in this case. 20. In considering whether a period of suspension would be sufficient to mark the seriousness of Dr Lewis’ actions, uphold the reputation of the profession and protect public safety, the Tribunal were mindful of paragraphs 97(e), (f) and (g), which state:

97 Some or all of the following factors being present (this list is not exhaustive) would indicate suspension may be appropriate.

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e No evidence that demonstrates remediation is unlikely to be successful,

eg because of previous unsuccessful attempts or a doctor’s unwillingness to engage.

f No evidence of repetition of similar behaviour since incident. g The tribunal is satisfied the doctor has insight and does not pose a

significant risk of repeating behaviour. 21. The evidence before the Tribunal suggests that remediation is unlikely to be successful. Dr Lewis has made it clear that he rejects criticism of his prescribing practices and he has chosen not to engage with these proceedings. 22. The Tribunal has seen no evidence that Dr Lewis has continued to prescribe in the manner found in these proceedings. However, his misconduct occurred over the course of several years and involved a high volume of patients. Further, as noted, Dr Lewis has not accepted any criticism of his prescribing practices. 23. Dr Lewis’ attitude and response to the allegations against him suggests that there is a significant chance of repetition. No evidence has been provided that could assure the Tribunal that this is not the case. 24. The Tribunal concluded that the nature of Dr Lewis’ actions, exposing patients to unnecessary harm, combined with his refusal to engage or address these shortcomings, render his behaviour incompatible with continued registration as a medical practitioner. Erasure 25. The Tribunal then went on to consider the sanction of erasure. In doing so it was mindful of paragraphs 109 (a), (b), (i) and (j) of the Sanctions Guidance, which state: 109 Any of the following factors being present may indicate erasure is appropriate (this list is not exhaustive).

a A particularly serious departure from the principles set out in Good medical practice where the behaviour is fundamentally incompatible with being a doctor.

b A deliberate or reckless disregard for the principles set out in Good

medical practice and/or patient safety. …

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i Putting their own interests before those of their patients (see Good

medical practice paragraph 1: – ‘Make the care of [your] patients [your] first concern’ and paragraphs 77–80 regarding conflicts of interest).

j Persistent lack of insight into the seriousness of their actions or the

consequences …

26. The Tribunal reminded itself of the aggravating factors in this case. Dr Lewis exposed patients to significant risk through his reckless actions, and whilst no harm to patients has been proven, there was undoubtedly a risk of harm. This is compounded by his lack of insight into the failings in his practice and his lack of any remediation. Further, he has failed to cooperate with the GMC’s investigation and has failed to engage with this substantive hearing. 27. In light of the continued risk to patient safety and the lack of any meaningful response by Dr Lewis, the Tribunal concluded that a period of suspension would not reflect the seriousness of Dr Lewis’ misconduct. Dr Lewis has stated that he may wish to continue in private practice in some capacity, presenting an ongoing risk to public and patient safety. 28. The Tribunal was not satisfied that a period of suspension would effectively protect patient safety, nor uphold public confidence or the reputation of the profession in the specific circumstances of this case. 29. The Tribunal has therefore determined that the appropriate sanction is one of erasure. Any lesser sanction would not be sufficient to mark the seriousness of Dr Lewis’ actions or mitigate the risks Dr Lewis poses to the safety of the public and the reputation of the profession. Dr Lewis’ erasure will also send an appropriate signal to members of the profession and the wider public that such behaviour is wholly incompatible with being a registered medical practitioner, upholding all three limbs of the overarching objective.

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Determination on Immediate Order - 27/01/2020 1. Having determined that Dr Lewis’ name should be erased from the Medical Register the Tribunal has considered, in accordance with Rule 17(2)(o) of the Rules, whether Dr Lewis’ registration should be subject to an immediate order. Submissions 2. On behalf of the GMC, Ms Fry submitted that, in light of the Tribunal’s findings, an immediate order of suspension should be imposed in order to ensure patient safety and to maintain public confidence in the medical profession. The Tribunal’s Determination 3. In reaching its decision the Tribunal referred to the relevant paragraphs of the SG. It exercised its own judgement and had regard to the principle of proportionality. The Tribunal has borne in mind that it may impose an immediate order where it is satisfied that it is necessary for the protection of members of the public, is in the public interest, or is in the best interests of the practitioner. It also took into account the submissions made by Ms Fry. 4. The Tribunal had regard to the following paragraph of the SG, namely in

relation to public protection and public interest:

172 The tribunal may impose an immediate order if it determines that it is necessary to protect members of the public, or is otherwise in the public interest, or is in the best interests of the doctor. The interests of the doctor include avoiding putting them in a position where they may come under pressure from patients, and/or may repeat the misconduct, particularly where this may also put them at risk of committing a criminal offence. Tribunals should balance these factors against other interests of the doctor, which may be to return to work pending the appeal, and against the wider public interest, which may require an immediate order.

5. The Tribunal has had regards to the terms of its determination and concluded that an immediate order of suspension is necessary in order to prevent Dr Lewis writing any further inappropriate prescriptions, thereby putting patient safety at risk. 6. The need to uphold public confidence in the profession is also essential. Dr Lewis has not cooperated with the GMC’s investigation and has not engaged constructively with this substantive hearing. The Tribunal has concluded that a reasonable and fully informed member of the public would consider it appropriate that Dr Lewis be suspended from practice immediately.

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7. This means that Dr Lewis’ registration will be suspended from the date when notification is deemed to have been served. The substantive direction, as already announced, will take effect 28 days from the date when written notice of this determination has been served upon Dr Lewis, unless an appeal is made in the interim. If an appeal is made, the immediate order will remain in force until the appeal has concluded. 8. The interim order currently in place is revoked.

9. That concludes the case.

Confirmed Date 27 January 2020 Mr William Hoskins, Chair

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ANNEX A – 23/01/2020

Application on Service and Proceeding in the Absence of the Doctor 1. Dr Lewis is neither present nor legally represented at this hearing. The Tribunal considered whether notice of this hearing had been properly served on him in accordance with Rule 31 and 40 of the General Medical Council (‘GMC’) (Fitness to Practise) Rules 2004, as amended (‘the Rules’). 2. Ms Fry provided the Tribunal with a copy of the service bundle which included:

• screenshots of the doctor’s registered postal address and email address; • a copy of the Notice of Allegation sent by post, dated 18 December 2019,

with an accompanying Royal Mail proof of service/tracking information; • a copy of the Notice of Hearing sent by post, dated 19 December 2019, with

an accompanying Royal Mail proof of service/tracking information, and; • an email thread from GMC which included a table of GMC and MPTS

documents and correspondence returned to the GMC’s London office by Dr Lewis, some of which had been opened and some of which had not, dated 03 December 2019 (documents dated between July 2018 and November 2019).

3. Ms Fry invited the Tribunal to consider the GMC Notice of Allegation letter, dated 18 December 2019, and the Medical Practitioners Tribunal Service’s (MPTS) Notice of Hearing letter, dated 19 December 2019. She submitted that the Tribunal had before it the courier’s proof of delivery demonstrating that delivery of the Notice of Allegation and Notice of Hearing letters to Dr Lewis’ registered address had been attempted and collection cards had been left for him. 4. Ms Fry also invited the Tribunal to consider the telephone note of a conversation between a member of the GMC legal team and Dr Lewis, dated 28 October 2019, submitting that this demonstrates that Dr Lewis was aware of the proceedings against him and discussed the upcoming pre-hearing meeting, which he ultimately declined to attend. 5. Ms Fry submitted that all reasonable efforts had been made to serve Dr Lewis and that service had been affected properly in accordance with the Rules. 6. Having considered the evidence, the Tribunal was satisfied that Notice of this Hearing had been served on Dr Lewis in accordance with Rule 15 and Rule 40 of the Rules, and paragraph 8 of Schedule 4 to the Medical Act 1983, as amended.

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Proceeding in Absence 7. The Tribunal then went on to consider whether it would be appropriate to proceed with this hearing in Dr Lewis’ absence pursuant to Rule 31 of the Rules. The Tribunal was conscious that the discretion to proceed in the absence of a doctor should be exercised with the utmost care and caution, balancing the interests of the doctor with the wider public interest. 8. In deciding whether to proceed with this hearing in Dr Lewis’ absence, the Tribunal carefully considered all the information before it, which included Ms Fry’s submissions and the communication and interactions Dr Lewis had with the GMC. 9. Ms Fry submitted that the evidence before the Tribunal makes it clear that Dr Lewis had been receiving the documentation at his registered address, and had chosen to ignore or disregard these communications, as evidenced by the return of both opened and unopened documents by him to the GMC. 10. Ms Fry invited the Tribunal to consider the telephone note in light of proceeding in Dr Lewis’ absence, submitting that this demonstrates that he did not intend to engage meaningfully with the proceedings. 11. Ms Fry submitted that Dr Lewis had voluntarily absented himself from this hearing, which has been demonstrated by the documentation and emails which the Tribunal has before it. She submitted that there was no indication that he would attend a reconvened hearing if the current hearing were adjourned, and Dr Lewis made no reference to the option of giving evidence via video link or telephone. Therefore, there would be no injustice in proceeding. 12. The Tribunal determined that Dr Lewis was aware of the proceedings against him and been made fully aware of right to attend and/or be represented, and all reasonable efforts had been made to serve notice of the current hearing. 13. The Tribunal also noted that Dr Lewis’ most recent engagement with the GMC on these matters did not suggest that he intended to participate further in the proceedings. 14. The Tribunal satisfied itself that Dr Lewis voluntarily absented himself from these proceedings; that there was no indication an adjournment would mean Dr Lewis would attend in the future; he had not asked for an adjournment or made an application to give evidence by video link or telephone link. 15. The Tribunal therefore determined that no purpose would be served by an adjournment, that there would be no injustice in proceeding, and that it was in the public interest to hear this case without delay.

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Schedule 1

Patient Date of prescription

Medication Prescription details

Patient H 1 September 2015 Sprycel 150 tablets, 5 packs x 30, 100mg tablet, one tablet daily

Patient I 30 September 2016 Sprycel 4 packs for 4 months, 100mg tablets, one tablet daily

Schedule 2

Patient Date of prescription

Medication Prescription details

Patient J 28 November 2013 Tysabri Five month supply, 20mg/1ml, 15ml vial (one vial) 300mg infusion every 4 weeks

Patient K 29 November 2013 Tysabri Five month supply, 20mg/1ml, 15ml vial (one vial) 300mg infusion every 4 weeks

Schedule 3

Patient Date of prescription

Medication Prescription details

Patient A 28 November 2013 Remicade 17 week supply, 12 vials of 100mgs

Schedule 4

Patient Date of prescription

Medication Prescription details

Patient L 20 May 2015 Celsentri 180 tablets, 3 packs, 150mgs, one tablet twice daily

Patient M 20 May 2015 Celsentri 180 tablets, 3 packs, 300mgs, one tablet twice daily

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Schedule 5

Patient Date of prescription

Medication Prescription details

Patient N 28 August 2015 Truvada 150 tablets, 5x30, one tablet daily

Schedule 6

Patient Date of prescription

Medication Prescription details

Patient D

XXX

10 August 2016 Prezista 6 months’ supply, 6 packs, 800mg tablets, one tablet daily

Schedule 7

Patient Date of prescription

Medication Prescription details

Patient O 21 May 2014 Trizivir 3 months’ supply, 60 tablets, one tablet twice daily, 3 packs, 180 tablets

Schedule 8

Patient Date of prescription

Medication Prescription details

Patient C

XXX

12 August 2016 Eviplera 6 months’ supply, 6x30 tablets, one tablet daily

Schedule 9

Patient Date of prescription

Medication Prescription details

Patient D

XXX

3 October 2015 Atripla 6 months’ supply, one tablet daily

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Patient P

XXX

3 October 2016 Atripla 4 packs for 4 months’ supply, one tablet daily

Schedule 10

Patient Date of prescription

Medication Prescription details

Patient Q 15 August 2016 Viread 5 months’ supply, 245mg, take one daily