City and Hackney Clinical Commissioning Group Homerton University Hospital Foundation Trust

Joint Prescribing Group (JPG) Minutes

Date: Monday 11 March 2019 Time: 12.30pm – 2.00pm Venue: Brooksby House Meeting Room, HUHFT Chair: Dr Haren Patel Note taker: Anh Vu

Present: Dr Louise Abrams, Clinical Pharmacologist, Joint Chairperson, HUHFT (LA) Dr Laurence Blumberg, Prescribing Lead GP, City and Hackney CCG (LB) Saima Chowdhury, Principal Pharmacist for Clinical Services, HUHFT (SC) Rozalia Enti, Director Medicines Management, City and Hackney CCG (RE) – in attendance from agenda item 2.6 onwards Dr Wande Fafunso, Prescribing Lead GP, City and Hackney CCG (WF) Susana Fontelo Rojano, ELFT Lead Pharmacist for City and Hackney, ELFT (SFR) Sagal Hashi, Joint Formulary Pharmacist and JPG Secretary, HUHFT and City and Hackney CCG (SH) Hassan Ladha, Principal Pharmacist for Operational Services, HUHFT (HL) Katti Nwosu, Prescribing Advisor, City and Hackney CCG (KN) Elizabeth Ozogolu, Senior Prescribing Advisor, City and Hackney CCG (EO) – in attendance from agenda item 2.4 onwards Dr Haren Patel, Prescribing Lead GP, Joint Chairperson, City and Hackney CCG (HaP) Professor Raja Rajakulasingam, Consultant Physician in Respiratory Medicine and Allergy, HUHFT (RR) Dr Piero Reynolds, Consultant Rheumatologist, HUHFT (PiR) Michael Vidal, Patient and Public Involvement Representative (MV) Anh Vu, Interim Joint Formulary Pharmacist and JPG Secretary, HUHFT and City and Hackney CCG (AV) Iola Williams, Chief Pharmacist, HUHFT (IW)

Guests:

1.0 Minutes and Matters Arising 1.1 Apologies, welcome and introductions

1.2 Declaration of Interest (DOI) All JPG members were given an opportunity to declare any updates to their DOI. A JPG member declared interest for agenda items 2.2 (non-financial professional interest) and 2.3 (non- financial personal interest).

1.3 Minutes Minutes from February 2019 JPG meeting were reviewed and agreed as accurate.

Agenda Items 2.1 NICE technology appraisal update

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The group was informed that 5 NICE technology appraisals (TAs) required JPG review since the meeting in February 2019. The JPG’s decision for each of the published TAs are summarised in the table below. Explanation of JPG decisions:  Approved (positive NICE TA) – The JPG agreed to approve this medicine for use at Homerton University Hospital Foundation Trust provided it is used in accordance with the relevant NICE TA.  Not approved (negative NICE TA) – The JPG agreed not to approve this medicine as currently NICE cannot recommend its use.  Not approved (positive NICE TA but service not available at HUHFT) – The JPG agreed not to approve this medicine for use at Homerton University Hospital Foundation Trust as the trust does not provide this specialist service. The JPG recommends the funding of this medicine to enable it to be prescribed or initiated at specialist hospitals accredited to provide this medicine, provided it is used in accordance with the relevant NICE TA. TA Title JPG decision Formulary status TA560 Bevacizumab with carboplatin, gemcitabine and Not approved (negative BLUE (Non-formulary at paclitaxel for treating the first recurrence of NICE TA) HUHFT. Hospital only for platinum-sensitive advanced ovarian cancer other providers that have (terminated appraisal) this on their formulary) TA561 Venetoclax with rituximab for previously treated Not approved (positive BLUE (Non-formulary at chronic lymphocytic leukaemia NICE TA but service not HUHFT. Hospital only for available at HUHFT) other providers that have this on their formulary) TA562 Encorafenib with binimetinib for unresectable or Not approved (positive BLUE (Non-formulary at metastatic BRAF V600 mutation-positive NICE TA but service not HUHFT. Hospital only for melanoma available at HUHFT) other providers that have this on their formulary) TA563 Abemaciclib with an aromatase inhibitor for Not approved (positive BLUE (Non-formulary at previously untreated, hormone receptor-positive, NICE TA but service not HUHFT. Hospital only for HER2-negative, locally advanced or metastatic available at HUHFT) other providers that have breast cancer this on their formulary) TA564 Dabrafenib with trametinib for treating advanced Not approved (negative BLUE (Non-formulary at metastatic BRAF V600E mutation-positive non- NICE TA) HUHFT. Hospital only for small-cell lung cancer (terminated appraisal) other providers that have this on their formulary)

2.2 Regional Medicines Optimisation Committee (RMOC) – Maintaining patency of central venous catheters in adults. Position Statement on heparinised saline for central venous catheter lock in adults. The RMOC (London) reviewed the evidence base for use of heparinised saline in adults as a solution to lock a central venous catheter (CVC) line in order to maintain its patency. The RMOC recommends that there is no role for routine use of heparinised saline lock for the purpose of maintaining patency of a CVC in adults, and that sodium chloride 0.9% (saline) is suitable for locking CVCs in the majority of adult patients. A JPG member informed the group that the intensive care unit at HUHFT currently uses saline solution for the flushing of central venous catheter lines.

JPG decision: The JPG agreed to approve the RMOC position statement on heparinised saline for central venous catheter lock in adults.

2.3 Guideline for choice of blood glucose meters, testing strips and lancets in adults with uncomplicated type 2 diabetes (update) The group was informed that the guideline was updated to reflect new recommendations from the Driver and Vehicle Licensing Agency (DVLA) for self-monitoring of blood glucose levels prior to driving. The DVLA now recommends that drivers of group 1 cars and motorcycles who are prescribed insulin, may use interstitial glucose monitoring systems to test blood glucose prior to and every 2 hours whilst driving. Another change related to the price for the Accu-Chek® Performa Nano test strips (one of the

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recommended products), which was recently reduced by the manufacturer; the guideline had been updated to reflect this price change.

JPG decision: The JPG agreed to approve the updated guideline for choice of blood glucose meters, testing strips and lancets in adults with uncomplicated type 2 diabetes.

2.4 Medicines schedule The group was informed that the medicines schedule is included in the CCG-HUHFT contract. City and Hackney CCG requires that the pharmaceutical and prescribing services of all providers comply with the details and performance indicators included in the medicines schedule. The group had a discussion the medicines reconciliation component of the medicines schedule.

Outcome of discussion: The JPG agreed for HUHFT to submit medicines reconciliation data to City and Hackney CCG (as part of the medicines schedule) via local audits.

2.5 Thick & Easy® discussion The group had a discussion around the use of thickening powder at HUHFT. The JPG was informed that the trust had recently implemented the switch from Thick & Easy® Original to Thick & Easy® Clear powder. A JPG member raised a concern that HUHFT had made the switch to Thick & Easy® Clear without taking into account the impact this may have on primary care. The group had a general discussion around this issue.

2.6 Interface issues

A JPG member gave a summary of the feedback from practice support pharmacists (PSPs) on interface issues:

a. Prescribing of bath emollients The City and Hackney CCG and HUHFT joint guideline on emollients does not recommend routine prescribing of bath emollients. A PSP fed back that dermatologists at HUHFT had been asking GPs to continue prescribing bath emollients for both adult and paediatric patients despite recommendation against the use of bath emollients by local guideline.

I was noted that patients are often prescribed emollients by the hospital for dry skin and then expect these to be continued by the GP. However, current recommendation is that patients should be advised to purchase emollients over the counter (OTC) when they are used for dry skin without a diagnosed dermatological condition, for example eczema and psoriasis. A JPG member suggested that all relevant clinicians in secondary care should be reminded that they should not initiate emollients for dry skin in hospital as these may not be continued in primary care.

A JPG member queried whether it would be possible to add a statement to the dispensing label to inform patients that their GP may not be able to prescribe their emollient after discharge. A member replied that the pharmacy dispensing system (JAC) does allow customisation of labels. Another member commented that it would not be possible for the pharmacy dispensing staff to differentiate between patients who are prescribed an emollient for dry skin and those who are prescribed this for a skin condition. Another member suggested that the statement could be added to the fire safety leaflet that is already given out to patients who are supplied emollients by the hospital. A member suggested that the pharmacy department could do a mini review of 20 inpatient prescriptions for emollients to check their appropriateness; the committee can then decide on what action to take following a review of the audit results. Another member commented that often patients would present with itching secondary to dry skin and prescribing an emollient to treat the dry skin may prevent a referral to the secondary care specialist clinic.

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b. Issuing of blood glucose meters for adult patients with uncomplicated type 2 diabetes A PSP fed back that practices have been issuing meters that are not recommended by the City & Hackney CCG and HUHFT joint ‘Guideline for choice of blood glucose meters, testing strips and lancets in adults with uncomplicated type 2 diabetes’. It was noted that this situation does seem to be improving with training and communication with diabetes specialist nurses.

c. Prescribing of baby milk formula A PSP fed back that dieticians have been recommending baby milk products in quantities in excess of what is recommended by local guideline. The group was informed that the guideline for the prescribing of specialist infant formulae requires updating. The community dietetic team had been asked to help update the document but they were waiting for a paediatric dietician to be in post.

d. Discharge summaries from HUHFT A PSP fed back that some of her GPs have commented that the discharge summaries from HUHFT are detailed and well laid out and they arrive promptly, compared to others trusts (e.g. Barts and UCL).

e. Prescribing of enoxaparin A PSP fed back that a GP informed her that she had received 2 requests from HUHFT for continuation of enoxaparin for oncology patients and she is currently following this up with the hospital. It was noted that HUHFT only has shared care guideline for obstetric indications and not for oncology patients on chemotherapy who are unable to use an oral anticoagulant. It was noted that the majority of patients would go to Barts for management of their cancer and they would be prescribed a low molecular weight heparin by Barts oncology clinic. A JPG member stated that patients with lung cancer would be initiated on enoxaparin at HUHFT. Several members of the JPG commented that it may be appropriate to have a HUHFT shared care or transfer of care document for enoxaparin for this indication.

2.7 Drug application – Imunovir® (inosine pranobex) for the treatment of recalcitrant warts after treatment failure/intolerance to standard therapy

An Associate Specialist in Sexual Health at HUHFT (the applicant) was present to support the application and answer any specific questions.

The applicant informed the JPG that there had been a rise in the number of cases of genital warts being treated at HUHFT since 2006, (the group were informed that this date was used as a marker as this was when the Human papillomavirus (HPV) vaccine was introduced to girls nationally). He informed the group that he was not stipulating that the increased number of cases was linked to HPV, however he was keen to identify if the new cases are in a particular age group or demographic. He stated that identifying this may help to determine the cause of the increase. The applicant also noted that the increase in cases could be due to more patients being seen by the sexual health clinics so this could be a proportional increase. This number does not include recurrent cases of warts. The applicant stated that last year, 54 patients were referred for laser treatment. HUHFT have a laser unit and treat resistant warts. It was also stated that patients with resistant warts are often referred to HUHFT from other centres. He informed the group that this was his area of interest.

The applicant provided some background to the management of genital warts, he highlighted that management of warts is different depending on the warts site and morphology, for example penile shaft warts are difficult to treat. He also stated that areas which are difficult to visualise are very difficult to treat and that patient preference for treatment type also has an impact. The applicant stated that in addition to this, recalcitrant warts also need different treatment options to what is currently available on formulary. He explained that patients often do not like having to come into hospital regularly for treatment, which is required with laser therapy.

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The applicant stated that this application was for inosine pranobex (Imunovir®) for the treatment of recalcitrant anogenital warts. He explained that this treatment would not be first line and he would only want to use it for the following cohort of patients:

 Where patients did not respond to treatment given in the department guidelines (podophyllotoxin, cryotherapy, imiquimod, Catephen®) or developed reaction to such treatments.  Where is it not possible to offer topical treatments (due to overlying conditions: psoriasis, lichen sclerosus, chronic dermatitis)  Warts in difficult to visualise or difficult to treat areas: intrameatal; intranal, cervical, vaginal and occasionally oral  Where laser treatment may not be appropriate.  There is currently a 3 month wait for laser treatment therefore patients may be suitable for treatment with Imunovir® whilst awaiting laser treatment.

The applicant added that often patients also decline laser treatment as it can lead to pain and scaring. He explained that Imunovir® would be used in combination with other agents. He stated that the evidence for Imunovir’s® effectiveness was not as robust as one would like. In light of this, he informed the group that in the application pack there was a list of all hospitals that are currently offering this treatment. A pathway for Imunovir’s® place in therapy and potential combinations was included with the application and reviewed by the JPG.

The applicant informed the group that one hospital he had contacted has treated 390 patients with no reports of any side effects including the buildup of uric acid. He stated that he has asked that the audit results from this hospital are shared with him. A JPG member asked the applicant how many patient he would likely treat with Imunovir®. The applicant stated that around 20-30 in a year at most.

A JPG member asked the applicant if he was requesting approval for an unlicensed use of Imunovir®. The applicant responded that he would like to use Imunovir® in combination with standard therapy. He explained that the treatment options that it would be combined with i.e. Catephen® were not on the market when Imunovir® was launched. PS stated that using Imunovir with Catephen® or imiquimod would have an additive beneficial effect. A JPG member highlighted that Imunovir® does not feature in NICE, SMC, BASHH guidelines on the treatment of warts. The group was informed that Imunovir® was first available in the 1980s but its high cost had limited its use. The applicant informed the group that since then it has fallen out of fashion. He emphasised that this treatment option would be for recalcitrant warts only. A JPG member asked why no other London hospital has approved its use. Another member echoed this and added that the application form cites use of Imunovir® in private hospitals, however the formulary of private hospitals are not managed in the same way as an NHS hospital, therefore comparisons cannot be drawn. Another JPG member added that as Lambeth, Southwalk and Lewisham have a similar cohort of patients to City and Hackney, and asked if there were any reasons why Imunovir® was not on the South London formulary. The applicant stated that some of those patients came to HUHFT as they provide a laser unit. A JPG member highlighted that Birmingham hospital has used this. A JPG member suggested that application form should clearly state what our neighboring hospitals and other relevant hospitals’ formulary status is, however she was keen that this should not include private hospitals. The applicant responded that this information was included to highlight the large numbers of patients that Imunovir® used in and the subsequent lack of adverse events to highlight the safety of the medicine.

A JPG member asked for clarification regarding treatment options and success rates. The group had a general discussion regarding the effectiveness of current treatment choices. The applicant gave some anonymised data on patients he has already treated with Imunovir® and their feedback to him. It was explained that currently Imunovir® has some success but its use is not likely to gain much publicity as this

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is an old drug. He proposed that he would use this drug, which is no longer costly, in patients who have recalcitrant warts and have limited other options. The applicant informed the group he was happy to audit his use and report findings back to the JPG. He added that this treatment would be restricted, with clear informed consent. He stated that there would be very small patient numbers. A JPG member stated that she thought after looking at the data the medication was relatively harmless and a huge benefit would be that the patient could take the medication orally. The member asked the committee to consider this medication in a trial of 10 patients. Another JPG member suggested that the applicant continues to request Imunovir® use via Chairman’s action to the co-chairs and collects this data for 3 months. A JPG member asked if this was better suited for a clinical trial. A member stated that ideally this would be the preferred method, however given that this drug is off patent, it would be difficult to get funding for this type of trial. The applicant stated that 3 months would not give sufficient time to collect sufficient patient data, given the likely limited use of this medication. The applicant clarified that the use of Imunovir® would not be repeated but that treatment could be continued for 3 months.

The JPG agreed to decline the use of Imunovir®; it was given a Red non-formulary status with the caveat that this may be available via chairman’s action.

Drug: Imunovir® (inosine pranobex) 500mg tablets - 1 gram three times daily Indication(s): Recalcitrant warts after treatment failure/intolerance to standard therapy JPG decision: Declined; request for use to be assessed on a case per case basis via Chairman’s Action. Formulary status: RED (not approved for prescribing)

2.8 Community health services (CHS) The CCG Project Lead Pharmacist (JPG guest) attended the meeting to update the JPG on medicines issues related to the recommissioning of community services. The group was informed that there is a recommissioning process going on for community services. It seems that this would be an opportunity to include details about medicines in the revised contract for community services. The JPG guest stated that some of the service leads in the community has expressed concerns about being expected to pick up issues relating to medicines as opposed to issues relating to social services; they were therefore looking for clarity on this. The group had a discussion around this issue.

3.0 Standing items 3.1 MHRA Drug Safety Update Key messages from February 2019 Drug Safety Update:  Carbimazole: increased risk of congenital malformations; strengthened advice on contraception.  Carbimazole: risk of acute pancreatitis.  SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum).

3.2 Horizon scanning A summary of the relevant formulary decisions made by the NCL JFC (January 2019) and the BH DTC (January and February 2019) were added to the JPG agenda pack for information.

3.3 Planned care and RMOC update There was no planned care updated this month. Two JPG members attended the RMOC (London) meeting on 07 March 2019. One member informed the group that the RMOC is currently undertaking a huge amount of medicines optimisation work. The other member informed the group that there will be a polypharmacy conference in May 2019 and they will be forwarding details of the conference to JPG members when they receive the email invitation for this.

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4.0 Any Other Business not on the Agenda Approval process for new drug applications The group had a general discussion around the approval process for new drug applications.

5.0 Information Only Items – For noting 5.1 Mercaptopurine SCG 5.2 NEJM journal watch – adverse effects of fluoroquinolones

6.0 Next Meeting Monday 08 April 2019, 12:30 – 2:00pm at Brooksby House Meeting Room, HUHFT.

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