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MKPAG Minutes 22.07.2020 Last printed 11/25/2020 11:25:00 AM Page 1 of 19 Milton Keynes Prescribing Advisory Group (MKPAG) JOINT NHS TRUSTS Notes of the meeting held on Wednesday 22 nd July 2020 Chair: Helen Chadwick, Clinical Director, Pharmacy, MKUH Name Job Title Attendance *Members who have submitted their annual Declaration of Interest form. Attendance to meeting was reviewed under the Terms of Reference. MKPAG Professional Secretariat Candy Chow (CC) Principal Pharmacist, Formulary & Interface Services Present MKCCG Janet Corbett (JC)* Head of Prescribing and Medicines Management, Chief Pharmacist Present Dr. Nigel Fagan (NF)* GP and MKCCG GP Prescribing Group representative Present Nikki Woodhall (NW)* Senior Medicines Management Technician Present >12.50 x Finance/ Contract Representative x MKUHFT Pharmacy Helen Chadwick (HC)* Clinical Director of Pharmacy and Chair of MKPAG Present Jill McDonald (JMcD)* Deputy Chief Pharmacist Clinical Services Apologies Zainab Alani (ZA) Pharmacy Manager, Medicine Safety and Governance Present Nicholas Beason (NB)* Chief Technician Apologies Sheila Wood (SW) Pharmacy Assistant, MKPAG and Formulary Present MKUHFT Dr Ian Reckless (IR) Medical Director Apologies Dr Angus Molyneux (AM) Core Clinical Triumvirate Lead, Consultant Pathologist Apologies Dr Andrew Cooney (AC) Deputy Medical Director Present Carol Jellicoe (CJ)* Advanced Nurse Practitioner Present Kate Power (KP) Clinical Governance Representative Present Tina Worth (TW) Head of Risk and Clinical Governance Present Dr. Mya Aye (MA) Medicines Optimisation Lead, Paediatrics Consultant Pediatrician Present Eleanor Tyagi (ET) Consultant Anesthetist Medicines Optimisation Lead, Surgery Present >12.30 Dr. Dushyant Mital (DM) Medicines Optimisation Lead, Medicine Consultant, Sexual Health Medicine Present >12.30 Dr Shindo Francis (SF) Lead Consultant in Emergency Department Apologies CNWL-MK Kikelomo Pinheiro (KP) Milton Keynes Pharmacy Lead, CNWL Present Lorraine Holl (LH) CNWL Post Vacant Consultant Psychiatrist, Mental Health x Nominated Representatives for agenda items Dr Lazlo Halmai (LH) Cardiology Consultant (Locum), MKUH Present Matthew Burnett (MB) Principal Pharmacist, Cardiology, MKUH Present Jane Stanger (JS) MKUH Lead Dietician (Paediatric), MKUH 12.00-12.15 Invited Representatives None Note taker: Michelle McCarthy, PA / Pharmacy Office Manager Professional secretariat: Candy Chow, Principal Pharmacist Interface & Formulary Services
Transcript

MKPAG Minutes 22.07.2020 Last printed 11/25/2020 11:25:00 AM Page 1 of 19

Milton Keynes Prescribing Advisory Group (MKPAG)

JOINT NHS TRUSTS Notes of the meeting held on Wednesday 22nd July 2020

Chair: Helen Chadwick, Clinical Director, Pharmacy, MKUH

Name Job Title Attendance

*Members who have submitted their annual Declaration of Interest form. Attendance to meeting was reviewed under the Terms of Reference.

MKPAG Professional Secretariat

Candy Chow (CC) Principal Pharmacist, Formulary & Interface Services Present

MKCCG

Janet Corbett (JC)* Head of Prescribing and Medicines Management, Chief Pharmacist

Present

Dr. Nigel Fagan (NF)* GP and MKCCG GP Prescribing Group representative

Present

Nikki Woodhall (NW)* Senior Medicines Management Technician Present >12.50

x Finance/ Contract Representative x

MKUHFT – Pharmacy

Helen Chadwick (HC)* Clinical Director of Pharmacy and Chair of MKPAG Present

Jill McDonald (JMcD)* Deputy Chief Pharmacist – Clinical Services Apologies

Zainab Alani (ZA) Pharmacy Manager, Medicine Safety and Governance Present

Nicholas Beason (NB)* Chief Technician Apologies

Sheila Wood (SW) Pharmacy Assistant, MKPAG and Formulary Present

MKUHFT

Dr Ian Reckless (IR) Medical Director Apologies

Dr Angus Molyneux (AM) Core Clinical Triumvirate Lead, Consultant Pathologist Apologies

Dr Andrew Cooney (AC) Deputy Medical Director Present

Carol Jellicoe (CJ)* Advanced Nurse Practitioner Present

Kate Power (KP) Clinical Governance Representative Present

Tina Worth (TW) Head of Risk and Clinical Governance Present

Dr. Mya Aye (MA) Medicines Optimisation Lead, Paediatrics Consultant Pediatrician

Present

Eleanor Tyagi (ET) Consultant Anesthetist Medicines Optimisation Lead, Surgery

Present >12.30

Dr. Dushyant Mital (DM) Medicines Optimisation Lead, Medicine Consultant, Sexual Health Medicine

Present >12.30

Dr Shindo Francis (SF) Lead Consultant in Emergency Department Apologies

CNWL-MK

Kikelomo Pinheiro (KP) Milton Keynes Pharmacy Lead, CNWL Present

Lorraine Holl (LH) CNWL

Post Vacant Consultant Psychiatrist, Mental Health x

Nominated Representatives for agenda items

Dr Lazlo Halmai (LH) Cardiology Consultant (Locum), MKUH Present

Matthew Burnett (MB) Principal Pharmacist, Cardiology, MKUH Present

Jane Stanger (JS) MKUH Lead Dietician (Paediatric), MKUH 12.00-12.15

Invited Representatives

None

Note taker: Michelle McCarthy, PA / Pharmacy Office Manager Professional secretariat: Candy Chow, Principal Pharmacist – Interface & Formulary Services

MKPAG Minutes 22.07.2020 Last printed 11/25/2020 11:25:00 AM Page 2 of 19

Administrator: Sheila Wood, Pharmacy Assistant, MKPAG and Formulary

The minutes should be read in conjunction with the enclosures (new medicine applications, independent evaluations and references) circulated as pre-reading for the meeting.

ACTION

1 Welcome, apologies and introductions

1.1 The Chair opened the meeting and welcomed members. Apologies: Nick Beason, Jill McDonald, Dr Ian Reckless, Dr Angus Molyneux

2 Declaration of potential conflict of interest

2.1 No potential conflict of interests was declared. DM queried work that he does with a biomedical company but that it does not impact on the NHS and if this would be a conflict of interest. The Chair noted that it was best to declare in advance and any changes in circumstance, and any potential conflict of interests regarding agenda items can be noted at the individual meetings.

3 Acknowledgement of declaration of any other business not on the agenda

3.1 None

4 Notes of previous meetings

Minutes from the meeting held in January 2020 The following corrections were noted: 4.1 Page 4 – 8.1.6 VisuXL eye drops – Mr Bimal Kumar to clarify place in therapy, appears to have fallen off the Action Log.

4.1.1 CC noted that Mr Kumar has clarified its place in therapy and has updated the guidelines on management of dry eyes. Action: CC will double check if this guideline has been uploaded to the formulary and will re-circulate the updated version to the group.

4.2 Page 5 – 10.1 – HC and JC to clarify position for Pentosan polysulfate Sodium.

4.2.1 It was noted that HC and JC have not yet met to discuss. 4.2.2 Action: MM to book the meeting.

4.3 Page 6 – 10.4 – Fluocinolone acetonide action to add to the formulary, even though NICE haven’t approved.

4.3.1 Action: CC to look into previous minutes and check on the formulary and correct both as appropriate.

CC

MM

CC

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4.4 Page 7 – 10.08 – Confirmation of position of Lusutrombopag

4.4.1 Noted that it is CCG funded. Action: To be added to the formulary in line with NICE guidance and a Blueteq form is required.

CC / JC

4.5 Minutes from the virtual meeting held in March 2020 No comments were noted.

4.6 The MKPAG meeting in May 2020 was cancelled due to the Covid-19 pandemic.

5 Ratification of Prescribing Guidelines / Leaflets / Policies / Position Statements – PART 1

5.1 For approval: Appropriate Prescribing of Specialist Infant Formulae: A guide for Healthcare Professionals, by Jane Stanger – MKUH Lead Dietician (Paediatric) 5.1.1 JS presented this guideline which has been revised and updated. 5.1.2 JS advised the guideline was for use by the CCG and in the hospital. The guideline is to aid the management of common conditions and include 1st and 2nd line prescribing choices. 5.1.3 JC noted some of the formatting had misaligned due to the enclosure number boxes, but was assured this would be corrected for the final PDF version. 5.1.4 The guideline was approved for use. Action: 5.1.5 CC to upload the guideline to the formulary.

CC

6 Matters Arising from previous meetings

6.1

MKPAG Action Log was reviewed. 6.1.1 Action log is to be updated.

CC

7 Ratification of Prescribing Guidelines / Leaflets / Policies / Position Statements – PART 2

7.1 For noting: A number of BLMK Prescribing Guidelines:

Bulletin 1 v2.1: Prescriptions Guidance for Primary Care Teams in General Practices and Community Pharmacies

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Bulletin 2 (v2) : CCG Medicines Optimisation COVID-19 Primary Care Advice Bulletin: Drug Therapies used in Rheumatologic Conditions

Bulletin 3 (v2): Immunosuppressive medications used in dermatological conditions

Bulletin 4 (v4): BLMK CCG Medicines Optimisation COVID-19 Primary Care advice - COPD (Updated 17th April)

Bulletin 5 (v4): BLMK CCG Medicines Optimisation COVID-19 Primary Care advice - Severe Asthma (Updated 17th April)

Bulletin 6 (v3): BLMK CCG Medicines Optimisation COVID-19 Primary Care advice - IBD (Crohn's Disease and Ulcerative Colitis) (Updated 28th April)

Bulletin 7: BLMK CCG Medicines Optimisation COVID-19 Primary Care Advice - Commissioning Statement :- Prescribing and Monitoring of Patients requiring treatment with Specialist Medicines (NHS England Commissioned)

Bulletin 8 (v2): BLMK CCG Medicines Optimisation COVID-19 Primary Care advice - Immunosuppressive medication used in Chronic Renal Disease (Updated 17th April)

Bulletin 9 : BLMK Medicines Optimisation COVID-19 Primary Care Bulletin : End of Life Care Medicines Prescribing Guidance

Local Standard Operating Procedure for Re-use of Medicines (applicable during Covid-19 Pandemic)

These have been circulated to all GP practices and can be accessed locally through ClarityNet and also the Bedfordshire website GPRef: https://www.gpref.bedfordshire.nhs.uk/referrals/covid-19-information.aspx 7.1.1 JC noted that these guidelines are on the agenda for formal noting and these were produced in response to the Covid-19 pandemic, primarily to support Primary Care prescribers with managing patients on complex medications particularly in Gastro, Rheumatology and Dermatology. 7.1.2 JC acknowledged and thanked the staff and clinicians at MKUH for their prompt responses in supporting Primary Care in the complex response to Covid-19. 7.1.3 JC noted that these documents will not be archived just yet in case they are required again at short notice. 7.1.4 JC requested the group for thoughts and ideas regarding the best way to bring patients out of this emergency situation and out of shielding which will likely be over a longer period of time. Returning to the new normal will be a

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gradual process and will be based on individuals. Noted that there is also concern about a situation if we need to go into lockdown again. 7.1.5 As a result, it was agreed not to offer guidance on the process for patients “coming out” of the pandemic/shielding as opposed to the “going in”. 7.1.6 JC noted that these guidelines are kept on the Bedfordshire website GPRef, but this site will cease to exist in November, and the CCG are currently in consultation and communication with colleagues in Bedfordshire & Luton around a system-wide medicines management platform. In MK, guidelines tend to be centralised on the formulary website, whereas in Bedfordshire & Luton these tend to be put on the GPRef website as a separate resource. JC noted these cultural differences. 7.1.7 HC queried if the acute Trusts get to have a say in how these information from the CCG and the medicines management team are shared across the area. 7.1.8 JC responded that the GPRef public site is open to all, and the group will probably need some offline discussions locally about how we proceed and whether we continue to have the information on the formulary or just a link on the formulary to the other site as the documents have to be hosted somewhere. 7.1.9 HC agreed that a link might be the best option to keep all documents in one place. Happy to discuss these outside of the meeting and to give an update at MKPAG next time.

HC / JC

8 Shared Care Guidelines

8.1

8.1.1 CC noted that there are none to be discussed today, however there are several Shared Care Guidelines which require updating and reviewing. 8.1.2 CC is working on a list to add to the action log and will update at the next meeting.

CC

9 Applications to add medicines / devices to the formulary

9.1 Change of Formulary Status: Oxcarbazepine (tablets and oral suspension) – from Amber 3 to Amber 1 9.1.1 A request for a change of status from Amber 3 to Amber 1. 9.1.2 JC noted some concern around its place in Primary Care. 9.1.3 It was agreed that this would be better placed at Amber 1 on recommendation from a hospital specialist. 9.1.4 CC to update the status on the formulary to Amber 1.

CC

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9.2 Change of formulary status: Levetiracetam (tablets and oral solution) – from Amber 3 to Amber 1 9.2.1 A request for a change of status from Amber 3 to Amber 1. 9.2.2 JC noted some concern around its place in Primary Care. 9.2.3 It was agreed that this would be better placed at Amber 1 on recommendation from a hospital specialist. 9.2.4 CC to update the status on the formulary to Amber 1.

CC

9.3 Formulary Application: Midodrine (See also proposed flowchart algorithm) 9.3.1 MB presented the application for midodrine on behalf of Dr Halmai, the request is to add midodrine to the formulary for the treatment of orthostatic hypotension due to autonomic dysfunction and vasodepressive syncope. 9.3.2 MB noted that fludrocortisone is previously used regularly for this but is still unlicensed for this indication. 9.3.3 MB also presented the flowchart algorithm as an aide for prescribing management, which notes consultant initiation and prescribing of the first prescription with a review in 3 months, which would be done by the hospital specialist as agreed in the meeting. At the 3-month review, the patient will be assessed for any improvement seen and whether a dose titration would be required. 9.3.4 This would be followed by a 12-month review with a view to reduce the dose of midodrine and then stop the treatment. This is to be picked up and monitored by the GPs in Primary Care. 9.3.5 LH joined the virtual meeting at this point and advised that the first aim would be not to use pharmacological measures for the patient, but focus on physical and lifestyle changes which are effective in roughly 50% of patients who end up not needing pharmacological treatment at all. 9.3.6 LH advised that fludrocortisone is not licensed for this indication and there is experience of fludrocortisone causing leg oedema especially at higher doses, whereas midodrine is much more effective. The flowchart is a practical way of guiding clinicians on which patients should be started on midodrine. Patients are reassessed; if patients have a good and stable response they would not be left on midodrine indefinitely but rather their dose can be tapered down with a view to gradually stop. 9.3.7 The group agreed this was a good and practical algorithm.

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9.3.8 JC noted concern around the evidence base not being good and what the evidence base was between dichotomy of putting patients on fludrocortisone first vs midodrine in the over 65’s and those with Parkinson’s etc. and what the rationale for that split is. 9.3.9 JC also asked about the potential numbers – could be quite a lot higher than 25 patients per year, presumably it is 25 patients started on midodrine per year so cumulatively the numbers will be greater. 9.3.10 JC also noted that in terms of the algorithm, more clarity is needed about the GP’s role. 9.3.11 LH responded that he has no evidence available on the class of this medication and that the evidence is based on the European guideline recommendations. Based on these, it is thought that the more elderly patients and those with Parkinson’s may benefit more from the fludrocortisone as they would be less likely to experience some of the side effects such as ankle oedema, as opposed to younger patients. 9.3.12 LH advised that midodrine has been shown to be more superior so could benefit more from the alpha stimulant effect rather than the plasma expander effect of fludrocortisone. 9.3.13 LH also noted that the age limit would not be set in stone, this was just a practical suggestion. 9.3.14 LH also confirmed that the specialist in Secondary Care will provide the 3-month review for these patients, whether it being a clinic review or a virtual review. 9.3.15 JC queried in the algorithm where the stepping up of fludrocortisone box states to be increased after two weeks, would the hospital be initiating the first month therefore taking into account the step up? It was agreed that yes, the hospital would be initiating the first month and doing the step up of dose. JC agreed that this would allow GPs more time to get the patient set up. 9.3.16 ZA noted there were no ownership details, date of document and expiry date on the algorithm document. 9.3.17 The group agreed to approve the addition of midodrine to the formulary subject to the clarity on GP responsibilities and the additions required on the flowchart. Actions: 9.3.18 MB to update the algorithm document to confirm that the hospital will complete the 3-month review and that the patient is stable before moving the responsibility to GPs.

MB

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9.3.19 MB to add more clarity to the flowchart algorithm with what is required from the GPs. 9.3.20 MB to add ownership details, date of document and expiry date to the algorithm document. 9.3.21 Once these amendments are completed, CC to add midodrine to the formulary as Amber 2 in line with local guidance, and to upload the algorithm document to the formulary. 9.3.22 Usage review to come back to the group in 12 months’ time.

MB

MB

CC

MB

9.4 Formulary Application: Prilocaine hydrochloride, Prilotekal®

9.4.1 ET presented the application for adding Prilotekal 2% for spinals to the formulary. ET also noted that an application for adding prilocaine 1% to the formulary as an alternative to lidocaine will follow shortly. 9.4.2 ET advised that this would be used as an alternative to heavy bupivacaine. Prilocaine has a much shorter duration of action so it will wear off quicker and the motor block wear-off is quicker; this means it could be used for day case surgeries and most ‘-oscopies’. 9.4.3 CJ also noted that there would only be about 12 patients a year. Action: 9.4.4 Approved. CC to add this to the formulary (hospital use only).

CC

9.5 Formulary Application: 4Sure Smart Duo – an additional blood glucose plus blood ketone meter 9.5.1 JC presented the application for adding this new blood glucose meter to the formulary. The Blood Glucose Monitors policy across the health economy historically had only one dual meter which reads ketones and blood glucose. 9.5.2 This was Glucomen Areo which has had issues with sticks. There was also some concern from the Diabetes team about patients’ abilities to use the Glucomen Areo machine and the reliability of results obtained. This prompted an alternative to be added to be used with the CareSens machine so as not to rely on one option. 9.5.3 The request has been made to add the meter rather than switch, as there are still a lot of patients on the Glucomen Areo. To keep the 4Sure Smart Duo as an alternative rather than switching everyone, so it would be helpful to have the addition.

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9.5.4 JC confirmed that the application has been agreed with internal and external Diabetic Teams. 9.5.5 ZA asked JC if a yellow card reporting has been completed for the concerns. JC advised she would check. Action 9.5.6 Approved. CC to add this to the formulary as Green.

JC

CC

10 Formulary Amendments (From March to 21st July 2020)

10.1

Formulary additions, deletions and NICE adherence checklists updated for this period 10.1.1 Codeine linctus – HC noted a new process which was introduced during the Covid-19 pandemic to allow formulary amendments and approval to happen quickly outside of the normal MKPAG meetings. 10.1.2 The agreed process is that Pharmacy, Governance and relevant prescribing personnel review the document, before being submitted for approval at the Hospital Gold Meeting. The document will then come to MKPAG for noting. 10.1.3 It was agreed by the group that the process will be kept in place going forward for the time being.

11 Published NICE Technology Appraisals (TA) [Innovation, Health & Wealth – compliance with 90-day statutory requirement]

11.1 Carried forward from March 2020 NICE TA618: Atezolizumab with carboplatin and nab-paclitaxel: Indication: Non-small-cell lung cancer Disease category: Commissioning responsibility: PbR excluded: Implementation by: (Terminated appraisal)

11.2 Carried forward from March 2020 NICE TA619: Palbociclib with fulvestrant Indication: Advanced breast cancer Disease category: Cancer Commissioning responsibility: Currently CDF until NICE review on whether or not to recommend it for use on the NHS (PALOMA-3 clinical study ongoing). There is a managed access agreement, which includes a patient access scheme and a commercial access agreement.

For noting by individual Trusts

MKPAG Minutes 22.07.2020 Last printed 11/25/2020 11:25:00 AM Page 10 of 19

PbR excluded: Yes Implementation by: 15th April 2020 11.2.1 Add to formulary in line with NICE Guidance.

SW

11.3 Carried forward from March 2020 NICE TA620: Olaparib Indication: Ovarian, fallopian tube or peritoneal cancer Disease category: Cancer Commissioning responsibility: Currently CDF until NICE review on whether or not to recommend it for use on the NHS. There is a simple discount patient access scheme and a commercial access agreement, which form part of the managed access agreement when olaparib is used in the CDF. PbR excluded: Yes Implementation by: 15th April 2020 11.3.1 Add to formulary in line with NICE Guidance.

SW

11.4 Carried forward from March 2020 NICE TA621: Osimertinib Indication: EGFR mutation-positive non-small-cell lung cancer Disease category: Cancer Commissioning responsibility: Osimertinib does not meet NICE's criteria to be considered a life-extending treatment at the end of life and to be included in the CDF as it does not have the potential to be cost effective at the price offered, thus osimertinib is not recommended for use in the CDF. PbR excluded: Implementation by: 22nd April 2020 11.4.1 Add to formulary in line with NICE Guidance.

SW

11.5 Carried forward from March 2020 NICE TA622: Sotagliflozin (with insulin) Indication: Treating Type 1 diabetes Disease category: Endocrinology Commissioning responsibility: CCG PbR excluded: No Implementation by: 12th April 2020 11.5.1 Add to formulary in line with NICE Guidance for the moment. 11.5.2 CC to chase Dr Ali Endocrinologist to understand its place in therapy and other options available.

SW

CC

11.6 Carried forward from March 2020

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NICE TA623: Patiromer Indication: Hyperkalaemia Disease category: Commissioning responsibility: CCG (but we are not planning to use it locally for long term conditions) PbR excluded: No Implementation by: 13th May 2020 11.6.1 It was noted that this was looked at as part of a haemofiltration fluid shortage option. It is not being planned to be used unless in extreme emergency situations. 11.6.2 Add to the formulary in line with NICE Guidance, for hospital use only.

SW

11.7 Carried forward from March 2020 NICE TA624: Peginterferon beta-1a Indication: Relapsing–remitting multiple sclerosis Disease category: Commissioning responsibility: Already commissioned by NHS England – To add to the formulary but we do not currently provide the service for treating this condition. PbR excluded: Yes Implementation by: 19th May 2020 11.7.1 Noted that this service is not provided at Milton Keynes. 11.7.2 Add to formulary in line with NICE Guidance and to note the above point on the formulary.

CC

11.8 NICE TA625: Recombinant human parathyroid hormone for treating hypoparathyroidism Indication: Disease category: Commissioning responsibility: PbR excluded: Implementation by: (Terminated appraisal)

11.9 NICE TA626: Avatrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure (hospital only) Indication: Disease category: Commissioning responsibility: CCG PbR excluded: Implementation by: 24th September 2020

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11.9.1 Add to formulary in line with NICE Guidance. 11.9.2 JC to set up the Blueteq form.

SW

JC

11.10 NICE TA627: Lenalidomide with rituximab Indication: Previously treated follicular lymphoma Disease category: Cancer Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 7th July 2020 11.10.1 Add to formulary in line with NICE Guidance.

SW

11.11 NICE TA628: Lorlatinib Indication: Previously treated ALK-positive advanced non-small-cell lung cancer Disease category: Cancer Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 13th August 2020 11.11.1 Add to formulary in line with NICE Guidance.

SW

11.12 NICE TA629: Obinutuzumab with bendamustine Indication: For treating follicular lymphoma after rituximab Disease category: Cancer Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 13th August 2020 11.12.1 Add to formulary in line with NICE Guidance.

SW

11.13 NICE TA630: Larotrectinib Indication: For treating NTRK fusion-positive solid tumours Disease category: Cancer Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 27th August 2020 11.13.1 Add to formulary in line with NICE Guidance.

SW

11.14 NICE TA631: Fremanezumab Indication: Prevention of migraine Disease category: Central nervous system Commissioning responsibility: CCG PbR excluded: Implementation by: 3rd September 2020

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11.14.1 Add to formulary in line with NICE Guidance. 11.14.2 JC noted that a Blueteq form has been completed.

SW

11.15 NICE TA632: Trastuzumab emtansine Indication: Adjuvant treatment of HER2-positive early breast cancer Disease category: Cancer Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 10th September 2020 11.15.1 Add to formulary in line with NICE Guidance.

SW

11.16 NICE TA633: Ustekinumab Indication: For treating moderately to severely active ulcerative colitis Disease category: Commissioning responsibility: CCG PbR excluded: Yes Implementation by: 17th September 2020 11.16.1 BLMK review of ulcerative colitis pathway is required to see where/how this fits with the NICE TA. MKUH is to be included in the review. 11.16.2 Add to formulary in line with NICE Guidance. 11.16.3 JC to set up the Blueteq form.

JC

SW

JC

11.17 NICE TA634: Daratumumab with lenalidomide and dexamethasone Indication: For untreated multiple myeloma Disease category: Commissioning responsibility: PbR excluded: Implementation by: (Terminated appraisal)

11.18 NICE TA635: Ramucirumab with erlotinib Indication: For untreated EGFR-positive metastatic non-small-cell lung cancer Disease category: Commissioning responsibility: PbR excluded: Implementation by: (Terminated appraisal)

11.19 NICE TA636: Eculizumab Indication: For treating refractory myasthenia gravis Disease category: Commissioning responsibility: PbR excluded:

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Implementation by: (Terminated appraisal)

11.20 NICE TA637: Ranibizumab Indication: For treating diabetic retinopathy Disease category: Commissioning responsibility: PbR excluded: Implementation by: (Terminated appraisal)

11.21 NICE TA638: Atezolizumab with carboplatin and etoposide Indication: For untreated extensive-stage small-cell lung cancer Disease category: Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 1st October 2020 11.21.1 Add to formulary in line with NICE Guidance.

SW

11.22 NICE TA639: Atezolizumab with nab-paclitaxel Indication: For untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer Disease category: Commissioning responsibility: NHSE PbR excluded: Yes Implementation by: 1st October 2020 11.22.1 Add to formulary in line with NICE Guidance. 11.22.2 JC requested for the NICE TA compliance spreadsheet that was previously used to monitor adherence to NICE TAs to be uploaded on the new formulary for information.

SW

CC

11.23 For noting: NHSE Clinical Commissioning Policies for the following HIV drugs:

• Delstrigo (doravirine) https://www.england.nhs.uk/wp-content/uploads/2019/11/1822-Policy-for-publication.pdf

• Dovato and Juluca (dolutegravir) https://www.england.nhs.uk/wp-content/uploads/2019/01/Dolutegravir-for-treatment-of-HIV-1-infection-all-ages.pdf

(Delstrigo= Doravirine 100mg/lamivudine 300mg/Tenofovir disoproxil 245mg Dovato= Dolutegravir 50 mg/Lamivudine300mg Juluca= Dolutegravir 50mg/Rilpivirine 25mg)

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11.23.1 Agreed to adopt in line with the Clinical Commissioning Policies. 11.23.2 Add to formulary in line with the Clinical Commissioning Policies.

CC

12 NICE Highly specialized technologies guidance (HST)

12.1 None

13 Safety Issues from the Medicines and Device Safety Team

Carried forward from March 2020 Drug Safety Update: January 2020 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/861112/Jan-2020-PDF-final.pdf 13.1 ZA noted she has pulled out some key areas to discuss. 13.2 Ondansetron: noted. 13.3 Letter to healthcare professionals regarding Ranitidine shortage:

13.3.1 This shortage continues to be an issue for MKUH especially in the injectable form. Currently this is our most critical issue causing us problems. 13.3.2 ET advised this was discussed at recent Obstetrics and Anaesthetists meeting. The omeprazole alternative would not be a good idea as it isn’t licensed and is more difficult to give at time of a general anaesthetic, so happy to stick with existing plan of giving oral in labour and if not give sodium citrate that’s always given in addition to ranitidine. 13.3.3 ET also added that this has been added to their Risk Register. 13.3.4 ZA noted that we will eventually run out but will have to deal with that at the time. 13.3.5 HC queried we are still seeing patients coming into hospital with ranitidine, what is the status of supply in the community? NF confirmed that they are unable to get any supply, any patient coming in with it is likely to be using their own supply.

13.4 Supporting yellow card and raising awareness, ZA has been unable to get any response from MHRA regarding obtaining access to our yellow card reporting for Milton Keynes.

13.4.1 ZA highlighted the need to begin to raise awareness and promote reporting via the yellow card system, especially following the recent direct safety update for patients who are on multiple medications.

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13.5 Covid-19 drug safety update with a summary for the use of ibuprofen and NSAIDs, anti-hypertensives, and chloroquine & hydroxychloroquine. There is a yellow card app to share and report any Covid-19 related issues. 13.6 ZA asked the group what they feel would be the best way to share this information to raise awareness. Information has already been added to the eCare prescribing system and shared via email within the Trust, but if anyone has any ideas on how to improve communication then please let ZA know. 13.7 JC confirmed that these information are reviewed and fed back to practices and prescribing groups. NF noted that on their CQC inspections they are required to show evidence of how these are handled and actioned. 13.8 HC added that going forward with eCare, we may be able to target patients we have in the hospital that are impacted and target specific clinicians.

Carried forward from March 2020 Drug Safety Update: February 2020 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/865491/Feb-2020-PDF.pdf

Drug Safety Update: March 2020 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/873524/March-2020-PDF.pdf

Drug Safety Update: April 2020 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/881559/April-2020-DSU-PDF.pdf

Drug Safety Update: May 2020 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/886750/May-2020-DSU.pdf

14 Audit & follow up of previous recommendations

14.1 14.1.1 For noting: 6-month review of use of cannabis-based medicinal products – was due for reporting in July 2020 but to be postponed to September 2020 due to the pandemic. 14.1.2 The 6-month usage review of use of Lidocaine Plasters was also due for reporting in July 2020, but is to be postponed to January 2021 as this has not been rolled out yet as the draft letter to GPs written by CJ was not ready until this meeting.

15 Chairman’s action for information & oversight

15.1 Codeine linctus was added to the formulary in response to the pandemic, as this is recommended for cough in palliative patients as per both local and

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NHSE Palliative Care guidelines. Codeine linctus was added as Green but for use in Palliative Care only. Chairman’s update of the rapid assessment process for proposals for amendments to the joint formulary as a result of Covid-19. A blank copy of the short form application is attached. 15.1.1 Both comments were noted.

16 Feedback from other groups

16.1

Proposal for agreement: Adoption and implementation of the East of England Prescribing Advisory Committee (PAC) documents in MK. 16.1.1 JC advised that she has become a member of PAC and has found it helpful to see other options and suggestions made by the East of England PAC, and that it may be useful to have a section in this committee where their papers could be shared and considered for local implementation in MK. 16.1.2 It was agreed by all and approved to include these going forward.

17 Any other business

17.1 New Formulary (NetFormulary) update: launch and documents. 17.1.1 CC started by thanking everyone from the CCG and MKUH who helped and contributed to the building and sorting of the new formulary website. It was a huge piece of work, and everyone’s patience was appreciated during this time. 17.1.2 JC noted that there may be a few documents from Nottingham still on the pages on the formulary. CC added that there is now a generic prescribing formulary mailbox that has been set up to deal with any formulary-related queries. If anyone notices any out of date documents or issues/queries, they are to email the mailbox with the specifics so it can be looked at. 17.1.3 NF added a thank you for all the work that has been put in, he has found it much easier to use than the previous formulary site. 17.1.4 NF also suggested adding a note to the front page of the formulary to advise of the new formulary generic mailbox email address in order for users to reach the formulary team. CC to add this.

CC

17.2 Carried forward from March 2020 For noting: Ranitidine: All formulations update – Supply Notification, issued 12/06/2020 17.2.1 Noted.

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17.3 Incident Report – for discussion and sharing the learning 17.3.1 ZA highlighted an incident for sharing that covered the MK interface, regarding a patient who had their insulin missed off their discharge letter, resulting in missed doses and the patient being readmitted to hospital. 17.3.2 The dispensing required a dosette box and there was a query regarding the insulin, and in order to not delay the dosette dispensing and patient discharge, the prescription was sent without the insulin which was to be matched later. Unfortunately, in the meantime, the nurse on the ward had finalised the discharge letter and sent it to the GP. Therefore, when the Dr and Pharmacist had amended the discharge letter, the updated version was not re-sent to the GP therefore they were not advised that the original discharge letter was superseded.

17.3.2.1 The missing insulin was not escalated by the District Nurse, who was booked to administer the insulin to the patient, that the medication was missing. 17.3.2.2 The eCare prescribing system failed to notify GPs of updated discharged letters; this will be rectified going forward.

17.3.2.3 Shared learning across all interfaces needed.

17.3.2.4 District Nurses are advised to raise any query if unsure. JC to send ZA the name of a DN who she can liaise with regarding feedback on this issue and going forward.

17.3.3 JC queried that the action with eCare to correct the error was back in February 2020. It was noted that there was another anomaly around informing of changes but not of cancellations, this has also now been received and is ready to go live this week. Any later discharges will be clearly noted to show it has been updated. 17.3.4 NF advised that each practice would deal with the discharges differently and based on what they said, quite often they will not be seen by the GP if there are no changes to note.

17.3.4.1 NF noted he would try and find a ‘live’ discharge summary as what comes through doesn’t necessarily match what is thought to have been sent through.

17.3.5 It isn’t known if the patient had received a discharge letter but KP noted if he had the old one then this may be why the DN missed the insulin.

17.3.5.1 There was a conversation around understanding if the DNs are administering the insulin in which case needles should be supplied by CNWL or if the patient self-administers and received via prescription.

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17.3.5.2 JC noted that there is a piece of work being planned with Diabetic teams and will add this as an action to pick up.

17.4 Valproate, First do no harm Report – for noting and brief discussion 17.4.1 ZA has circulated an email regarding actions to alert notifications. It would be useful to get together with the CCG and CNWL to combine actions to ensure consistency in the message and to ensure nothing has been missed. 17.4.2 KP and JC were in agreement with a meeting for ZA to set up.

ZA

17.5 Class 2 Drug Alert: Desmopressin Nasal Spray (All Strengths), Ferring Pharmaceuticals Limited (issued 15/07/2020) – for noting 17.5.1 Noted this product is not off the market and is still available and used at MKUH. 17.5.2 CC to check with ADP whether the Trust keeps any of the listed batches.

CC

17.6

JC will feed back some minor comments to CJ via email regarding the draft letter to GPs on lidocaine patches.

18 Future Agenda Items

18.1 Separate listing available on request. 18.1.1 Future agenda items and any audit reports will be added here as a reminder for when they are due.

19 Date of next meeting

Wednesday 23rd September 2020 Venue: TBC


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