Tayside ADTC Supplement No 183 - March 2021

TAYSIDE PRESCRIBER ADTC Supplement No 183 ADTC Supplement No 183 -- March 2021March 2021

Asthma Biologics Updates

Omalizumab (Xolair®), mepolizumab (Nucala®) and

benralizumab (Fasenra®▼) for severe asthma have now been

updated to Amber traffic light status (can be prescribed in

General Practice following initiation on the recommendation of

the Severe Asthma MDT) in the Tayside Area Formulary.

Treatment is initiated and monitored by the Respiratory Service

(Severe Asthma MDT). The initial 3 doses (or until the patient is

considered suitable for self-administration) together with

training and supervision will be provided within the Clinical

Investigation Unit (CIU) at Ninewells Hospital or Perth Royal

Infirmary. Thereafter, GPs will be asked to prescribe the

relevant asthma biologic. Patients will be reviewed in the

Respiratory outpatient clinic/MDT regularly where continued

response to treatment will be monitored.

Local treatment protocols for all 3 formulary asthma biologics

have been updated to reflect the change in prescribing status

and are linked to from the formulary entries:

Tayside benralizumab treatment protocol for adults (Staffnet

intranet link only)

Tayside mepolizumab treatment protocol for adults (Staffnet

intranet link only)

Tayside omalizumab treatment protocol for adults and

adolescents 12 years+ severe persistent allergic asthma (Staffnet

intranet link only)

An NHS Tayside severe asthma MDT patient pathway and

severe asthma MDT biologic treatment pathway have also been

developed and are linked to from the formulary.

All patients will be supplied with 3 months of treatment from

secondary care in April, and therefore the first primary care

prescriptions for these medicines will be required around

beginning of July 2021.

Local Treatment Protocol: Naldemedine

Naldemedine (Rizmoic®▼) is a peripherally acting opioid receptor antagonist similar to naloxegol. It was accepted by SMC for use

within NHS Scotland in April 2020. It has recently been added to the Tayside Area Formulary (Amber traffic light) for prescri bing

under the direction of a specialist for treatment of opioid-induced constipation in adults who have previously been treated with first

line osmotic and stimulant laxatives at maximum tolerated doses (including docusate and bisacodyl) and who have had an inadeq uate

response. A new local treatment protocol for naldemedine (available as a Staffnet intranet link only) has been developed.

The following key prescribing points should be noted:

Naldemedine acts by decreasing the constipating effects of opioids without reversing the centrally mediated effects of opioid s

GP prescribing is under the direction of a specialist (Palliative Care/ Chronic Pain and Gastroenterology)

Naldemedine should NOT be used first line for opioid induced constipation

Naldemedine can be used with or without other laxatives, and can be taken with or without food

Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent

obstruction, due to the potential for gastrointestinal perforation are not suitable for naldemedine

Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquin avir,

telithromycin and clarithromycin should be avoided with naldemedine. If use with strong CYP3A inhibitors is unavoidable,

monitor for adverse reactions

Effectiveness of naldemedine should be reviewed after 14 days by the initiating prescriber and stopped if ineffective

Refer to local treatment protocol for further information. Healthcare professionals are reminded to report any suspected adverse

reactions with naldemedine as it is subject to additional monitoring (carries a black triangle symbol ▼) as a new medicine.

Tayside ADTC Supplement No 183 - March 2021

TAYSIDE PRESCRIBER ADTC Supplement No 183 ADTC Supplement No 183 -- 20212021

Surgery Formulary Review

The Surgery specialist formulary list and relevant parts of the formulary have been reviewed and updates published in the Tayside

Area Formulary.

Key updates to the formulary and specialist formulary list include:

Addition of indication ‘gastric motility disorders [unlicensed use ‘off -label’]’ to domperidone, metoclopramide and erythromycin

(Amber traffic light) with warning not to use if increased gastro-intestinal motility would be harmful e.g. gastro-intestinal

obstruction or gastro-intestinal perforation

For domperidone, metoclopramide and erythromycin for gastric motility disorders, discontinue after 3 -4 months if ineffective,

secondary care to review safety and efficacy every 6 months up to a maximum of 5 years, then annual review of safety and

efficacy by primary care thereafter

Link to iloprost infusion protocol and NICE Evidence summary on intravenous iloprost removed as there is now a licensed

preparation available

Glyceryl trinitrate 0.4% (Rectogesic®) – changed from Amber to Green traffic light

Glyceryl trinitrate ointment 0.2% (unlicensed special) changed to non-formulary as no longer used

Indication ‘prevention of complications following pancreatic surgery’ (Red traffic light) added to lanreotide as per octreoti de

Pabrinex® IV High Potency injection – addition of indication to reflect use in Surgical patients

Gastrografin® solution - indication updated to include all bowel obstruction

The following links have also been added to relevant parts of the formulary and Surgery specialist formulary list:

MHRA Drug Safety Update – Domperidone for nausea and vomiting: reminder of contra-indications in adults and adolescents, Dec

2019

MHRA Drug Safety Update: Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction wit h

rivaroxaban, December 2020

UKMI Q&A: What is the optimal prokinetic dose of erythromycin in adults? July 2020

NICE Evidence Summary: unlicensed or off-label medicine [ESUOM13] Gastroparesis in adults: oral erythromycin June 2013

NHS Tayside Inpatient management of high output stoma

BAPEN - The use of high dose loperamide in patients with intestinal failure, April 2018

Renal Formulary Review

The Renal specialist formulary list and relevant parts of the

formulary have been reviewed and updates published in the

Tayside Area Formulary.

Key updates to the formulary and specialist formulary list

include:

Rituximab (Truxima®▼) (Hospital Only – Red traffic light) –

update to indication for ANCA-associated vasculitis to

include maintenance; addition of indications for idiopathic

membranous nephropathy [off-label] and antibody mediated

rejection (AMR) in kidney transplant [off-label] with IV

methylprednisolone [off-label] and IV immunoglobulin

IV methylprednisolone (Hospital Only – Red traffic light) –

addition of indication in AMR in kidney transplant [off -label]

as above

Mycophenolic acid (as mycophenolate sodium) (Amber

traffic light) – removal of brand Myfortic® as generic

versions can be used

Hepatitis B vaccine for immunisation in patients with CKD

including those on haemodialysis (Amber traffic light) –

addition of Fendrix® brand due to supply issues with

HBvaxPRO® until the end of 2021

Co-trimoxazole – addition to Renal specialist formulary list

(Amber traffic light) for PCP prophylaxis indications as per

Renal Unit antibiotic prophylaxis guidance

Mupirocin nasal ointment – addition to Renal specialist

formulary list (Amber traffic light) for resistant cases of

staphylococci, reserved for the eradication of nasal carriage

of MRSA and MSSA on advice from Infection Control only

Argatroban (Hospital Only – Red traffic light) – changed to

non-formulary as no longer used

The following links have also been added to relevant parts of

the formulary and Renal specialist formulary list:

NHS Tayside Renal Unit Prophylaxis Guidance

Edinburgh Transplant Unit Protocol

Tayside ADTC Supplement No 183 - March 2021

New & Updated Formulary Links

MHRA Drug Safety Update: Erythromycin: caution required due to cardiac

risks (QT interval prolongation); drug interaction with rivaroxaban,

December 2020

MHRA Drug Safety Update, February 2021. Pregabalin: reports of severe

respiratory depression

MHRA Drug Safety Update February 2021. Esmya (ulipristal acetate 5mg):

further restrictions due to risks of serious liver injury

ABCD guidance (COncise adVice on Inpatient Diabetes (COVID:Diabetes):

FRONT DOOR GUIDANCE - UPDATE)

NHS Tayside Laryngopharyngeal reflux (LPR) Guidance (Staffnet intranet

access only)

Algorithm for Treatment of Overactive Bladder (OAB) in Primary Care

(Staffnet intranet access only)

TAYSIDE PRESCRIBER ADTC Supplement No 183 ADTC Supplement No 183 -- 20212021

SMC Advice

Published January 2021

Brentuximab vedotin 50mg powder for concentrate for solution for

infusion (Adcetris®) SMC2310

Brigatinib 30mg, 90mg and 180mg film-coated tablets (Alunbrig®)

SMC2314

Daratumumab 1,800mg solution for subcutaneous injection

(Darzalex®) SMC2326

Daratumumab 20mg/mL concentrate for solution for infusion

(Darzalex®) SMC2302

Entrectinib 100mg and 200mg hard capsules (Rozlytrek®) SMC2294

Fostamatinib 100mg and 150mg film‐coated tablets (Tavlesse®)

SMC2300

Secukinumab 150mg solution for injection in pre-filled syringe and

150mg solution for injection in pre-filled pen (Cosentyx®)

SMC2308

SMC ‘Not Recommended’ Medicines - January 2021

Apalutamide 60mg film-coated tablets (Erleada®) SMC2323

Dupilumab 300mg solution for injection in pre-filled pen and 300mg

solution for injection in pre-filled syringe (Dupixent®) SMC2324

Melatonin 1mg and 5mg prolonged-release tablets (Slenyto®)

SMC2306

Talazoparib 0.25mg/1mg hard capsules (Talzenna®) SMC2325

Published February 2021

Buprenorphine/naloxone 2mg/0.5mg and 8mg/2mg sublingual film

(Suboxone®) SMC 2316

Formoterol fumarate dihydrate / glycopyrronium bromide /

budesonide 5mcg/9mcg/160mcg pressurised inhalation, suspension

(Trixeo® Aerosphere) SMC2321

Leuprorelin acetate 3.75mg (Prostap® SR DCS) and 11.25mg

(Prostap® 3 DCS) powder and solvent for prolonged-release

suspension for injection in pre-filled syringe SMC2320

Leuprorelin acetate 3.75mg (Prostap® SR DCS) and 11.25mg

(Prostap® 3 DCS) powder and solvent for prolonged-release

suspension for injection in pre-filled syringe SMC2319

Ozanimod 0.23mg, 0.46mg and 0.92mg hard capsules (Zeposia®)

SMC2309

Ravulizumab 300mg concentrate for solution for infusion

(Ultomiris®) SMC2305

Upadacitinib 15mg prolonged-release tablet (Rinvoq®) SMC2315

SMC ‘Not Recommended’ Medicines - February 2021

Afamelanotide 16mg implant (Scenesse®) SMC (1251/17)

Links to Additional Information

Monthly Drug Safety Updates:

www.gov.uk/government/publications/drug-safety-update-monthly-

newsletter

For full details of medicines and forthcoming SMC Advice see SMC

Website:

www.scottishmedicines.org.uk

For a Summary of a Product’s Characteristics (SPCs) see Electronic

Medicines Compendium Website:

http://www.medicines.org.uk/emc/

For full details on NHS Board decisions see Tayside Area

Formulary - Local Decisions on SMC Advice database:

http://www.nhstaysideadtc.scot.nhs.uk/approved/formular/New

Meds Homepage.htm

Pharmacy Policy Page (Staffnet)

http://staffnet.tayside.scot.nhs.uk/OurWebsites/Pharmacy/

TaysideMedicinesGovernance/Policies/index.htm

Tayside ADTC Supplement No 183 - March 2021

Local processes exist to allow prescribing of non-SMC approved

medicines for individual patients and are available in the

Policy on Prescribing of Non-Formulary Medicines

(including PACS Tier 1 & 2)

Medicines within the Tayside Area Formulary are intended to guide

choice on a rational selection of medicines for adults which have

been included on the basis of clinical efficacy, safety, patient

acceptability and cost-effectiveness.

For full information on any of the drugs listed below use the link to the Scottish Medicines Consortium (SMC)

website below to search by generic, brand or SMC no.

See NHS Tayside ‘Local Decisions on SMC Advice’ database (link below) for full details on Board decisions -

these are currently listed alphabetically by page.

Other Formulary Updates

Jorveza® (budesonide orodispersible tablets) added to formulary (may be prescribed in general practice under the

direction of Gastroenterology specialist) restricted to prescribing for eosinophilic oesophagitis (EoE) in adults

unsuccessfully treated with proton pump inhibitors

Buprenorphine (Buvidal®) prolonged-release subcutaneous injection added to formulary (Hospital Only) restricted to

prescribing by Tayside Substance Misuse Service clinicians in line with local guidance.

Addition of sodium zirconium cyclosilicate (Lokelma®) to formulary (Hospital Only) restricted to use in heart failure

patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) and with CKD stage 3b to 5 who would

otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to

maintain a clinically acceptable serum potassium level (normokalaemia) in accordance with the local treatment protocol

(Staffnet intranet access only).

Solifenacin changed from 2nd choice to 1st choice and tolterodine changed from 1 st choice to 2nd choice antimuscarinics for

treatment of overactive bladder as per updated Algorithm for Treatment of Overactive Bladder (OAB) in Primary Care

(Staffnet intranet access only).

Hydrogen peroxide (Crystacide®) 1% cream added to formulary (Green traffic light) for use in acute impetigo on small

areas of skin (apply three times a day for 5 days) as an alternative to fusidic acid 2% cream. For further information or if

the impetigo is extensive or long standing see local guidance.

Indication for reduction of hypercalcaemia in adult patients with primary hyperparathyroidism in whom parathyroidectomy

is not clinically appropriate or is contraindicated added for cinacalcet (Amber traffic light) along with link to new local

protocol for primary hyperparathyroidism (Staffnet intranet access only).

Ciprofloxacin 0.3% and dexamethasone 0.1% - brand name Cilodex® removed as discontinued – available as a generic.

Naseptin® - dose 4 times daily for 10 days changed to 3 times daily for 2 weeks as per updated ENT Epistaxis guidance

(Staffnet intranet access only) for adults.

Estradiol vaginal tablets 10microgram, Vagifem® brand name removed so changed to a generic entry but note added:

Current most cost-effective preferred brand is Vagirux®. Other interchangeable brands include: Vagifem®.

Peginterferon alfa-2b (ViraferonPeg®) – removed from TAF as discontinued by manufacturer in December 2016.

Clobetasone Butyrate 0.05% cream now available as generic – formulary entry updated to remove Eumovate® brand.

Local implementation of SMC recommendations is taken forward by the Tayside Prescribing Support Unit (PSU). This bulletin is based on evidence available to the Tayside Prescribing Support Unit at time of publication and is covered by the NHS Tayside Privacy and Accessibility Statements.

This bulletin is produced by the Medicines Advisory Group (MAG),

which is a sub-group of the NHS Tayside Area Drug and Therapeutics

Committee. Please direct any queries to:

Hazel Steele, Lead Pharmacist, Prescribing Support E-mail: Hazel.steele@nhs.scot

Claire James, Senior Pharmacist - Clinical Effectiveness E-mail: Claire.james@nhs.scot

Karen Harkness, Principal Pharmacist, Clinical Effectiveness E-mail: Karene.harkness@nhs.scot