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Milton Keynes Prescribing Advisory Group (MKPAG)

JOINT NHS TRUSTS’ Notes of the meeting held on Wednesday 25th July 2018

Chair: Janet Corbett – Head of Prescribing and Medicines Management, Chief Pharmacist and Chair MKPAG

Name Job Title Attendance

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

MKPAG Professional Secretary

Dupe Fagbenro (DF)* Principal Pharmacist, MKPAG, Interface & Formulary Service Lead

Present

MKCCG

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

Present

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

Nikki Woodhall (NW)* Senior Medicines Management Technician Present

x Finance/ Contract Representative

x Formulary Service Representative

MKUHFT – Pharmacy

Helen Chadwick (HC)* Clinical Director of Pharmacy and Chair MKPAG Apologies –Jill McDonald (JMcD)* Deputy Chief Pharmacist – Clinical Services Present Zainab Alani (ZA) Governance and Medicine Safety Pharmacist Present

MKUHFT

Dr. Ian Reckless (IR) Medical Director For information only

Dr Andrew Cooney (AC) Deputy Medical Director Absent

Dr Rosemarie Daly (RD Consultant Microbiologist Absent

Carol Jellicoe (CJ)* Advanced Nurse Practitioner Present

Hani Patel (HP) Finance Contract Representative Apologies

Kate Power (KPo) Clinical Governance Representative Absent

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

Present 12.30-12.45

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

Apologies

Dr Sriram Naithilath (SN) Medicines Optimisation Lead, Surgery Consultant Anesthetist

Apologies

Dr. Premila Thampi (PT)

Medicines Optimisation Lead, Women Consultant Obstetrics & Gynecologist

Absent

Zulaika Van Aar Hospital Dietician (Team Leader) Apologies

CNWL-MK

Fahreen Hasham (FH) Lead Pharmacist, Mental Health, CNWL - MK Apologies

Post Vacant Consultant Psychiatrist, Mental Health -

Nominated Representatives for agenda items

Matthew Burnett (MB) Principal Pharmacist, Cardiology (Representing - Sudipta Chattopadhyay / Ticagrelor)

Present

Babalola Hakeem-Habeeb Principal Pharmacist, Surgery (Supporting Bill Smith / Binosto) Present

Invited Representatives

Rebecca Hinch (RH) Diabetes Specialist Nurse, MKUH Present Kelly Hodgson (KH) Diabetes Specialist Nurse, MKUH Present Heather Keogh (HK) Speech and Language Therapist, CNWL Present Fay Millichap (FM) Adult Manager, Speech and Language, CNWL Present

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Dr Laszlo Halmai (LH) Consultant, Cardiologist, MKUH Present Dr Bill Smith (BS) Consultant Rheumatologist, MKUH Present Dr George MacFaul (GM) Consultant Gastroenterologist, MKUH Present

Note takers: Michelle McCarthy, Pharmacy Office Manager and PA to Clinical Director of Pharmacy

Dupe Fagbenro, Professional Secretary MKPAG; Principal Pharmacist - Interface /Formulary Services

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. Members of the group and presenters introduced themselves.

Chair

2. Declaration of potential conflict of interest

2.1

No potential conflict of interests were declared

Chair

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

3.1

None declared

Chair

4. Notes of previous meeting – 27th March 2018

4.1

Enclosure 18.20 The minutes of the meeting held on the 27th March 2018 were accepted as an accurate record. Action Ratified minutes to be uploaded to the formulary

D Fagbenro

5. Matters arising from previous meeting

5.1

Enclosure 18.00 Refer to MKPAG action log for updates

Chair

5.2

Our local position for items which should not be routinely prescribed in primary

care 5.2.1 The eighteen products are: Co-proxamol, Dosulepin, Prolonged release doxazosin, Immediate release fentanyl, Glucosamine and chondroitin, Herbal treatments, Homoeopathy, Lidocaine plasters, Liothyronine, Lutein and antioxidants, Omega-3 fatty acid compounds, Oxycodone and naloxone combination product, Paracetamol and tramadol combination product, Perindopril arginine, Rubifacients [excluding topical non-steroidal anti-inflammatory drugs (NSAIDs)], Once daily Tadalafil, Vaccines administered exclusively for the purposes of travel, Trimipramine.

J Corbett

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5.2.2 It is anticipated that no new patients will be commenced on any of the items from now onwards, other than in exceptional circumstances (see below) However, we recognise that for patients who have been established on a product for some time, it may be necessary to explore further options, or seek further management advice prior to deprescribing. Where there is need for on-going prescribing under a co-operation arrangement, commissioners may request confirmation from prescribers that an agreement is in place, to allow for reconciliation against prescribing data 5.2.3 EXCEPTIONAL CIRCUMSTANCES - NEW PATIENTS We recognise there may be exceptional circumstances where it is clinically appropriate to fund one or more of the items for new patients and these will be considered on a case-by-case basis. Funding for such cases will be considered by the MKCCG following application to the Individual Funding Request Panel, whereby the IFR process will be applied. 5.2.4 (Post-meeting note) EXCEPTIONAL CIRCUMSTANCES – ESTABLISHED PATIENTS In the context of patients who are already established on one of the low value medicines for a licensed indication, the term “exceptional circumstances” should be interpreted as: “Where the prescribing clinician considers no other medicine or intervention is clinically appropriate and available for the individual.” Action To have a further discussion at the next meeting and come to a co-operation agreement 5.2.5 Lidocaine Plasters Commissioning Statement NOTE: This statement does not apply to patients who have been treated in line with NICE CG173 Neuropathic pain in adults: pharmacological management in non-`specialist settings but are still experiencing neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia) Apart from the exception above: Prescribers should not initiate lidocaine plasters for any new patient. Lidocaine plasters should be discontinued from primary care prescribing (deprescribed), with support from specialist services if necessary. If, in exceptional circumstances, there is a clinical need for lidocaine plasters to be prescribed in primary care, this should be undertaken in a cooperation agreement with a multi-disciplinary team and/or other healthcare professional. Patient Information Leaflet can be found on the formulary website at https://www.formularymk.nhs.uk/includes/documents/Patient-information-Changes-to-lidocaine-plaster-prescribing.pdf 5.2.6 Fentanyl, Immediate Release Commissioning Statement The statement below applies to prescribing outside NICE CG140 Opioids in Palliative

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Care. Prescribers should not initiate immediate release fentanyl for any new patient other than in line with NICE CG140 Opioids in Palliative Care. However, please note that immediate release fentanyl for palliative care is classified as RED (initiation and maintenance prescribing by specialist only) within MK, and even when use is in line with NICE CG140, primary care clinicians should not be asked to assume prescribing responsibilities. Immediate release fentanyl should be discontinued from primary care prescribing (deprescribed), with support from specialist services if necessary. Patient Information Leaflet can be found on the formulary website at https://www.formularymk.nhs.uk/includes/documents/Patient-information-Changes-to-immediate-release-fentanyl-prescribing.pdf 5.2.7 Once-daily Tadalafil Commissioning Statement Prescribers should not initiate once daily tadalafil for any new patient. Once daily tadalafil should be discontinued from primary care prescribing (deprescribed), with support from specialist services if necessary. It should be noted that once daily tadalafil is not on the Joint Trusts formulary and as such should not have been prescribed. Patient Information Leaflet can be found on the formulary website at: https://www.formularymk.nhs.uk/includes/documents/Patient-information-Changes-to-once-daily-tadalafil-prescribing.pdf 5.2.8 Lutein and Antioxidants Commissioning Statement Prescribers should not initiate lutein and antioxidants for any new patient. Lutein and antioxidants should be discontinued from primary care prescribing (deprescribed). Patient Information Leaflet can be found on the formulary website at: https://www.formularymk.nhs.uk/includes/documents/Patient-information-Changes-to-lutein-and-antioxidant-supplements-prescribing.pdf 5.2.9 Dosulepin Commissioning Statement Prescribers should not initiate Dosulepin for any new patient. Dosulepin should be discontinued from primary care prescribing (deprescribed), with support from specialist services if necessary. If, in exceptional circumstances, (where the prescribing clinician considers no other medicine or intervention is clinically appropriate and available for the individual) there is a clinical need for dosulepin to be prescribed in primary care, this should be undertaken in a cooperation agreement with a multi-disciplinary team and/or other healthcare professional. Patient Information Leaflet can be found on the formulary website at:

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https://www.formularymk.nhs.uk/includes/documents/Patient-information-Changes-to-dosulepin-prescribing.pdf The headache pathway is being reviewed and dosulepin should no longer be recommended for prescribing in primary care.

6. Ratification of Prescribing Guidelines / Leaflets / Policies

6.1 to 6.5

The New Aerochamber Plus Flow-VU Patient Information Leaflets Enclosures 18.21 to 18.25 6.1.1 JC updated the group on the new Aerochamber Plus Flow-VU range. A number of Patient Information Leaflets have been developed in order to optimize the use of the new devices, support compliance and ensure patient safety. The Patient Information Leaflets (PILs) are as follows:

Aerochamber Plus Flow-VU, The full range

Aerochamber Plus Flow-VU, How to use

Aerochamber Plus Flow-VU, How to use - Tidal Breathing

Aerochamber Plus Flow-VU, How to clean

Aerochamber Plus Flow-VU, children small medium mask

6.1.2 The PILs were approved. Action: 6.1.3 PILs to be uploaded to the joint formulary

N Woodhall

D Fagbenro

6.6

Vitamin K Prophylaxis in Newborn babies (A Guide for GPs) Enclosure 18.26 6.6.1 DF has put together a guidance for GPs in line with the Hospital Trust Guidelines on Vitamin K Prophylaxis in Newborn babies 6.6.2 In the UK, parents of new babies are routinely asked if their baby is to have supplementary vitamin K by injection or oral supplement, which is needed to make blood clot and prevent excessive internal bleeding. The Department of Health recommends that it be given usually by injection but a parent has a choice to decline and opt for vitamin k to be given by mouth. 6.6.3 Dose. A single intramuscular injection of vitamin K remains the gold standard. The most recent evidence continues to show an advantage of IM vitamin K even over repeat oral doses. If parents have opted for oral administration, Vitamin K is given by mouth as soon as possible after birth as Konakion MM Paediatric 2 mg (0.2 mls). This should be repeated in all babies as a single extra dose at 4 - 7 days. In those exclusively breast fed all babies should have a further dose as Konakion MM Paediatric 2 mg given at 1 month of

D Fagbenro

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age. Oftentimes the third oral dose is missed. This guide should help ensure the patient receives the entire course of oral vitamin k required and outlines the responsibilities of the Health Care Professionals. 6.6.4 A discrepancy in the cut-off age between the hospital policy and the licensed indication was noted. DF to look into this. Action:

6.6.5 Cut-off age to be agreed outside the meeting; Governance information to be added to the header and footer. Completed document to be brought back to the next meeting

D Fagbenro

6.7

Prescribing Guideline for Dry Eye Syndrome – Reviewed and updated Enclosure 18.27 6.7.1 The Chair withdrew this item from the agenda following a number of comments and questions to be answered. Action:

6.7.2 Add to September’s meeting agenda

D Fagbenro

6.8

Clinical features and treatment according to site of psoriasis in adults Enclosure 18.28 6.8.1 JC presented the newly developed primary care guide on the clinical features and treatment according to site of Psoriasis in Adults. 6.8.2 The treatment protocol is a user-friendly at-a-glance reference guide which is intended to help clinicians navigate through the various treatments available. 6.8.3 The treatment protocol strays a little from NICE and SIGN but is more patient-centered and clinically effective. 6.8.4 There are a number of medicines in the guideline that are not on the formulary. The group agreed that once the guideline has been agreed, a group application can be done for all the medicines which are:

Dovobet (calcipotriol 50mcg + betamethasone 500mcg / g) ointment

Dovobet (calcipotriol 50mcg + betamethasone 500mcg / g) gel

Dovonex (calcipotriol 50mcg / g) ointment

J Corbett

D Fagbenro

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Diprosalic (betamethasone 0.05% + salicylic acid 3%) ointment 6.8.5 The guideline was approved Action:

6.8.6 Non-formulary items will be considered as a group application 6.8.7 Guideline to be uploaded to the formulary after the September meeting when the drugs have also been approved.

D Fagbenro

D Fagbenro

7

Shared Care Guidelines

7.1

None to note

8

Applications to add medicines / devices to the formulary

8.1

Application for Humalog 200u/ml Kwikpen to be added to the formulary Enclosure 18.29 JC invited RH and KH to present their application on the use of Humalog 200 units/ml Kwikpen for use in a small cohort of patients 8.1.2 Safety concerns were noted around the number of patients and the possibility of another ‘Never Event’. The reason cited for the last Never Event was “unfamiliarity with the medication”. 8.1.3 All future insulin applications must have a completed RMOC safety factors checklist completed as part of the application process. Action 8.1.4 RMOC checklist has been partly completed. RH to arrange a meeting with Pharmacy to complete the safety factor checklist and risk assessment paperwork with Principal Pharmacist A&E / Medicine (QN) 8.1.5 A plan of action should be developed if completion of this checklist identifies areas where more work is needed before introducing the new product into the formulary 8.1.6 When 8.1.4 and 8.1.5 have been completed, reviewed and considered safe then add the

R Hinch

R Hinch

D

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insulin to the formulary; TLS Amber 1 8.1.6 Update full list of Insulins on the formulary 8.1.7 Prepare and publish OptimiseRx message for GPs

Fagbenro

D Fagbenro

J Corbett

8.2

Application for Nutilis Clear (gum-based thickener) to be added to the formulary 8.2.1 The Chair invited HK to present the application for Nutilis® Clear to be added to the formulary and the cost comparison with current practice. Enclosure 18.30 was presented. 8.2.2 The proposal is for one thickener (Nutilis® Clear) to be used across MK (Hospital Trust, CCG and CNWL-MK). HK confirmed that stakeholders from the three Trusts have been consulted. 8.2.3 The International Dysphagia Diet Standardisation Initiative (IDDSI) (IDDSI) have published international standardised terminology and definitions for texture modified foods and thickened liquids for people with dysphagia. The framework consists of a continuum of eight levels (0-7) and includes descriptors, testing methods and evidence for both liquid thickness and food texture levels. Information on the benefits of IDDIS and UK Expert group can be found here:

1. http://iddsi.org/

2. https://www.rcslt.org/clinical_resources/dysphagia/dysphagia_diet 8.2.4 Implementation of the IDDIS framework The Timeline can be found here: https://www.rcslt.org/clinical_resources/dysphagia/iddsiadoptionflyer Between April 2018 and April 2019 • Healthcare professionals lead local implementation from April 2018 • IDDSI compliant products, foods and labels start to become available from April 2018 • All manufacturers and health care settings are fully IDDSI compliant by April 2019 8.2.5 The over-riding goal of IDDSI is around patient safety in view of the many people that have choked and died on food from as young as 9 months to 95 years of age. Between 2017/18, there were 11 deaths on the MK Hospital coding attributed to Pneumonitis due to food and vomit inhalation. 8.2.6 Issues raised:

1. Cost implication for commissioners when compared with starch-based thickeners 2. There are concerns in care homes and we will need a robust plan on how the

training will be rolled out.

H Keogh

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3. The need to be fully IDDSI compliant by April 2019 4. Local Implementation of Patient Safety Alert: Resources to support safer

modification of food and drink (Published 27 June 2018) to be agreed between the CCG and the SaLT Team 8.2.7 JC asked HK that as we rapidly approach the deadline for the implementation of IDDSI – is it appropriate to do a switch of thickener now and the IDDSI training afterwards or to do the switching and training simultaneously. 8.2.8 The CCG asked the SaLT team to think of the practicalities of using up stocks already out in the community so we do not generate a lot of waste. 8.2.9 The Chair asked members if they are in support of us keeping Nutilis® Clear as our preferred thickener. Members agreed and asked that Carobel be added to the formulary for children and Nutilis® Powder – the starch-based product remain on the formulary as Amber 2 8.2.10 HK to come up with a robust implementation plan and liaise with

- The MKCCG – named contact – Janet Corbett - MK Hospital Trust – named contact – Jamie Stamp; - The communication that goes to GPs via TTO letters needs to be agreed

Action 8.2.11 Develop a robust implementation plan, working through a Task and Finish Group 8.2.12 Once the above plan has been agreed, add Nutilis® Clear to the Formulary; TLS - Amber 2. 8.2.13 Add Carobel to the Formulary

H Keogh D

Fagbenro

8.3

Application (abridged) to use Ticagrelor according to NICE TA236 & TA420 8.3.1 Following a review and update of the Hospital ACS Guideline, an application to extend the use of Ticagrelor (which is already on the formulary) was presented by LH 8.3.2 The use of Ticagrelor in line with NICE TA236 was approved 8.3.3 The use of Ticagrelor in line with NICE TA420 was approved 8.3.4 GPs will be required to regularly monitor renal function. Information to this effect, the duration of therapy and a stop date will be included in the discharge letter from the hospital. It was agreed for patients to be on Ticagrelor initially for one year with possible extension to 3 years following a cardiologist’s review only.

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Action 8.3.5 MB to share draft hospital guidelines with JC to ensure they cover the information that needs to go to GPs. 8.3.6 Extend the use of Ticagrelor in line with NICE TAs 230 and 420; TLS Amber 1

L Halmai/ M Burnett

D Fagbenro

8.4

Application for Ferric Maltol (Feraccru®) to be added to the formulary Enclosure 18.36 8.4.1 The Chair invited GM to present the application for addition of Feraccru® capsules to the formulary 8.4.2 Place in therapy: second line iron therapy for Iron Deficiency Anaemia in adult with mild to moderate IBD who have failed 2 oral ferrous products. To be considered prior to administration of IV options. 8.4.3 Members agreed the use of the drug in principle but were concerned that treatment may go on for more than the proposed 12 weeks. Action 8.4.4 Add to the formulary. TLS: Red in the first instance 8.4.5 Review use in 6 months and report usage and efficacy back to PAG

G MacFaul

D Fagbenro

D

Fagbenro

8.5

Product Name Change Application to change the name of an infant formulae on the formulary

Old name Cow & Gate Pepti-Junior

New name Aptamil Pepti-Junior

Enclosures 18.37, 18.38, 18.39 8.5.1 Members noted that this was a straight forward name change and agreed for the product and all associated and updated documents to be uploaded to the formulary

J Corbett

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Action 8.5.2 Formulary to be updated in line with 8.5.1 above

D Fagbenro

8.6

Application to add Binosto® to the formulary The Chair invited BS to present the application for Binosto® effervescent tablets (Alendronic acid 70mg) to be added to the formulary Enclosure 18.40 8.6.1 BS confirmed the place of Binosto® in therapy: 1st choice for patients who have swallowing difficulties 3rd choice for patients who are unable to tolerate the standard Alendronic acid and risedronate tablets 8.6.2 Binosto will remain an option to be tried before using Denosumab injection 8.6.3 It was mentioned that the GI side effects are not any less than the standard Alendronic acid or risedronate tablets but there is some evidence of improved compliance. However, the restrictions about remaining upright and taking the dose remote from meal times remains so it will not improve these aspects of compliance. Action 8.6.4 Add to the formulary; TSL - Amber 2 Hospital initiation, only after failure of standard Alendronic acid and risedronate in patients with difficulties in swallowing

B Smith

D Fagbenro

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8.7

Application to add Kyleena® to the formulary 8.7.1 The Chair presented the application for Kyleena® to be added to the formulary. This application was submitted by Dr Jenkins, the Lead Contraception Doctor based at the MK Sexual Health Clinic See Enclosure 18.41 for full details 8.7.2 Cost of relevant comparators

Medicine Brand name Dose regimen Cost per unit Cost per year

Levonorgestrel 19.5mg IUS

Kyleena® Up to 5 years £76 £15

Levonorgestrel 52mg IUS

Mirena® Up to 5 years £88 £18

Levonorgestrel 13.5mg IUS

Jaydess® Up to 3 years £69 £23

The application was approved and Kyleena® was recommended to be added to the formulary Action 8.7.3 Add Kyleena® to the formulary. TLS: Green

J Corbett

D

Fagbenro

9.

Formulary Amendments (November 2017 to date)

9.1

Additions, deletions and NICE compliance checklist update

a) Formulary amendments March to May 2018

b) Formulary amendments May to July 2018

D Fagbenro

10.

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

10.1 NICE TA 510: Daratumumab (Darzalex ®) 20mg/mL for treating relapsed and refractory multiple myeloma 10.1.1 NHSE funded Action 10.1.2 Approved for addition to the formulary and to be used in line with NICE guidance and

D Fagbenro

For noting by individual Trusts

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commissioning statements

10.2 NICE TA 511: Brodalumab (Kyntheum ®) for treating moderate to severe plaque Psoriasis 10.2.1 CCG funded Action 10.2.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements 10.2.3 Develop a Bluteq form

D Fagbenro

J Corbett 10.3 NICE TA 512: Tivozanib (Fotivda®) Capsules for treating advanced renal cell carcinoma

in adults 10.3.1 NHSE funded Action 10.3.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.4 NICE TA 513: Obinutuzumab (Gazyvaro®) for untreated advanced follicular lymphoma 10.4.1 NHSE funded Action 10.4.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.5 NICE TA 514: Not recommended Regorafenib (Stivarga®) for previously treated advanced hepatocellular carcinoma 10.5.1 Application not recommended – no action required

10.6 NICE TA 515: Not recommended Eribulin (Halaven®) for treating locally advanced or metastatic breast cancer after 1 10.6.1 Application not recommended – no action required

10.7 NICE TA 516: Cabozantinib (Cometriq®) for treating medullary thyroid cancer 10.7.1 NHSE funded Action 10.7.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

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10.8 NICE TA 517: Avelumab (Bavencio®) for treating metastatic Merkel cell carcinoma 10.8.1 NHSE funded Action 10.8.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.9 NICE TA 518: Tocilizumab (RoActemra®) for treating giant cell arteritis in adults 10.9.1 NHSE funded Action 10.9.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.10 NICE TA 519: Pembrolizumab (Keytruda®) for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy 10.10.1 NHSE funded Action 10.10.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.11 NICE TA 520: Atezolizumab (Tecentriq®) for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy 10.11.1 NHSE funded Action 10.11.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.12 NICE TA 521: Guselkumab (Tremfya®) for treating plaque psoriasis in adults 10.12.1 NHSE funded Action 10.12.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements 10.12.3 Develop a Bluteq form

D Fagbenro

J Corbett

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10.13 NICE TA522: Pembrolizumab (Keytruda®) for untreated locally advanced or metastatic urothelial carcinoma 10.13.1 NHSE funded Action 10.13.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.14 NICE TA523: Midostaurin (Rydapt®) for myeloid leukaemia 10.14.1 NHSE funded Action 10.14.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.15 NICE TA524: Brentuximab vedotin (Adcetris®) for Hodgkin lymphoma 10.15.1 NHSE funded Action 10.15.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.16 NICE TA525: Atezolizumab (Tecentriq®) for treating locally advanced or metastatic urothelial carcinoma 10.16.1 NHSE funded Action 10.16.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.17 NICE TA526: Arsenic trioxide (Trisenox®) for promyelocytic leukaemia 10.17.1 NHSE funded Action 10.17.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.18 NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis 10.18.1 NHSE funded

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Action 10.18.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.19 NICE TA528: Niraparib (Zejula®) for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer 10.19.1 NHSE funded Action 10.19.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.20 NICE TA529: Crizotinib (Xalkori®) for treating ROS1‑positive advanced non-small-cell

lung cancer 10.20.1 NHSE funded Action 10.20.2 Approved for addition to the formulary and to be used in line with NICE guidance and commissioning statements

D Fagbenro

10.21 NICE TA530: Not recommended Nivolumab (Opdivo®) for treating urothelial carcinoma 10.21.1 Application not recommended – no action required

11 Safety Issues from the Medicines and Device Safety Team

11.1 Drug Safety Update: April 2018 - Noted for reference only

D Fagbenro [JC, ZA,

FH]

11.2 Drug Safety Update: May 2018 - Noted for reference only

11.3 Drug Safety Update: June 2018 - Noted for reference only

12 Audit & follow up of previous recommendations

12.1 Nothing noted

13 Chairman’s action for information & oversight

13.1 Oxycodone Injection has been changed from Red to Amber 1

D Fagbenro

14 Feedback from other groups

14.1 Nothing noted

15 Sustainability and Transformation Plans (STPs)

Action: To forward to

the medicines safety team for each Trust for implementation

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Future Meeting Dates

Month Venue Meeting date Deadline for submission of agenda items including

applications for new drugs

September Room 4, Post Graduate Centre, MKUH

26th September 26th August

November Function Room, Eaglestone Restaurant, MKUH

28th November 28th October

15.1

Nothing noted

16 Regional Medicines Optimisation Committee (RMOC) Output

16.1 Enclosure 18.49: Insulin preparations. Safety factors for local formulary decision-making. Position Statement June 2018 16.2 Enclosure 18.50: Template checklist for insulin safety consideration June 2018 16.3 Members adopted the above documents and they will be used henceforth for all insulin formulary applications

D Fagbenro

17 Any other business

Enclosure 18.51: Responsibility for prescribing between Primary & Secondary / Tertiary Care 17.1 It was agreed that these contained some useful principles and will be used as a reference source going forward for any new shared care guidelines

J Corbett

18 Future Agenda Items

Vitamin B12 – Guideline for the treatment of Vitamin B12 and Folate disorders

D

Fagbenro

To update guideline(s): Management of irritable bowel syndrome with constipation (June 2017)

D

Fagbenro