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Epsom and St Helier University Hospitals NHS Trust FORMULARY Approved by: Medicines Management Committee Date approved: October 2016 Name of responsible committee/individual: Medicines Management Committee Last updated: October 2016 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -1- EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST FORMULARY INTRODUCTION The Epsom and St Helier University Hospitals NHS Trust Formulary is produced following consultation with Doctors, Specialist Nurses, Pharmacists and approved by the Medicines Management Committee. It aims to provide a list of medicines, which are cost effective and support evidence based prescribing. It provides a framework for defining where clinical and therefore prescribing responsibility should lie. The system is only advisory but is intended to clarify expectations of prescribing responsibility. All prescribing (i.e. in-patient, out-patient, Accident and Emergency, day case and FP10 prescribing) must comply with the formulary and Trust guidance on quantity of supply. Advice given to General Practitioners with regard to drug treatment options must also be in line with Trust formulary recommendations. This will be monitored on an ongoing basis. Private patients are not exempt from the Trust Formulary and doctors prescribing for private patients must comply with the Trust Formulary. The Epsom and St Helier University Hospitals NHS Trust Formulary is not applicable to other providers which the Pharmacy Department may deliver services to under a Service Level Agreement / Contract. Unlicensed medicines or licensed medicines used for an unlicensed indication have been included for use in specific clinical settings, where these have been approved by the Medicines Management Committee. Prescribers must take full responsibility for prescribing such products and comply with the Unlicensed Medicines Procedure. Contact your Ward Pharmacist or a member of the Medicines Management Team on 701 6075 or 721 4037/721 4038 for information relating to: - Evaluation of new medicines for inclusion in the Formulary - Obtaining supplies for patients admitted to hospital on non-formulary medicines - Obtaining an urgent supply of a non-formulary medicine for a specific patient Points to note: The Formulary is organised by historic BNF categories. Medicines which have a positive NICE Technology Appraisal (TA) or a Highly Specialised Technology (HST) evaluation are automatically included in the formulary where clinically appropriate and relevant to the services provided by the Trust, within 90 days of publication in line with statutory requirement. Other relevant NICE guidance relating to medicines will be reviewed by the Medicines Management Committee as appropriate. If the technology is not relevant to the care provided by the Trust, then the medication will not be initiated but will be available to patients admitted on therapy. Prescribing recommendations with respect to place in therapy for NICE approved medicines should only be applied after discussion of all treatment options with the patient and no preference indicated. Medicines available to all prescribers across the Trust have no restrictions next to them. Some medicines are limited to certain specialities/grades of staff, e.g. balsalazide (Gastroenterologists only) or for a specific indication, e.g. nimodipine (treatment of subarachnoid haemorrhage). Initiation of NICE approved medicines may be restricted to specialist teams for clinical or patient safety reasons, However, consideration will be given for treatment initiation outside of the specialist teams for patients who meet the NICE criteria. If no preparations are listed next to a medicine then all formulations are available, e.g. tablets, slow release tablets, suppositories etc. If specific formulations are stated then only those preparations are Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -2- stocked, e.g. fentanyl (injection and patches).If an unlicensed liquid is required or a tablet/capsule needs to be crushed or opened, then please speak with the ward Pharmacist who will advise further. All medicines are listed under pharmacopoeial or other non-proprietary titles. Any brand names are shown in inverted comas followed by e.g. ‘Norgalax’. All medicines conform with rINN naming, with BAN names shown in brackets after the rINN name. Disclaimer While every effort has been made to ensure that the content of the Epsom and St Helier University Hospitals NHS Trust Formulary is accurate and up to date we are unable to guarantee that the information is completely free from any inaccuracy. The links provided to other websites have been included for convenience and are to the websites of reputable organisations however we are unable to take responsibility for the availability or contents of these external sites. Epsom and St Helier University Hospitals NHS Trust will not be liable for any loss, damage or expense that might be caused by, or linked to, any action that a user might have taken as a result of using this site and other sites linked from it. The responsibility for application of the information lies solely with the user. We welcome feedback and if you discover any information on our pages which you believe to be inaccurate or misleading please contact: Medicines Management Team, c/o Pharmacy Department, Epsom and St. Helier University Hospitals NHS Trust, Wrythe Lane, Carshalton, Surrey SM5 1AA. Last updated October 2016 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -3- GLOSSARY OF TERMS A&E ACS ADHD BAN BNF CD Clinical Trial use only CCG CSM DH EC EOC ESTH Extemporaneous Product GUM/GU IM ITU/ICU IV LA/SR/CR/MR/XL/retard/SA Live MDT MRSA Named Patient Supply only NHSE NICE DOAC NSAID’s Ordered only when required PbR exclusion rINN Secondary Care only SLCSN Shared care guidance SWL Unlicensed medicine Unlicensed indication and/or dose VTE Accident and Emergency Acute Coronary Syndrome Attention Deficit Hyperactivity Disorder British Approved Name British National Formulary Controlled Drug This drug can only be prescribed by an approved Consultant in accordance with specific Clinical Trial Protocols Clinical Commissioning Group Committee on the Safety of Medicines. CSM recommendations are listed with the specific drug in the British National Formulary (BNF) Department of Health www.dh.gov.uk Enteric Coated Elective Orthopaedic Centre Epsom and St Helier University Hospitals NHS Trust A product manufactured by a Pharmacy Manufacturing Unit. Products may not be immediately available as they are made to special order Genito-Urinary Medicine Intramuscular Intensive Care Areas Intravenous Prolonged release formulations Vaccines with this description contain a live component, which can be life threatening if administered to an immunocompromised or pregnant patient. Multidisciplinary Team Methicillin Resistant Staphylococcus Aureus A medicine that can only be purchased for a specific patient under a named Consultant. Product Manufacturers may require patient information prior to issuing supply NHS England National Institute of Clinical Excellence www.nice.org.uk Direct Oral Anticoagulant Non-Steroidal Anti-inflammatory Drugs A supply will not be routinely held in Pharmacy and will only be ordered as requested Payment by Results. A list of nationally agreed drugs which have been excluded from tariff prices recommended International Nonproprietary Name Prescribing should remain within Epsom and St Helier University Hospitals NHS Trust South London Cardiac and Stroke Network Guidance to provide a framework for the seamless transfer of care from the hospital to general practice, where this is in the best interests of the patient. South West London A medicine with no UK product licence. An indication and/or dose for which the medicine is not currently licensed. The medicine holds a UK licence for other indications or doses. Venous Thromboembolism Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -4- NUCLEAR MEDICINE Stannous pyrophosphate kit ‘Angiocis’® Use for red cell labelling in patients with gastrointestinal bleeding and for left ventriculography BNF SECTION 1 GASTRO-INTESTINAL SYSTEM 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.1 Dyspepsia and gastro-oesophageal reflux disease Antispasmodics and other drugs altering gut motility Antisecretory drugs and mucosal protectants Acute diarrhoea Chronic bowel disorders Laxatives Local preparations for anal and rectal disorders Stoma care Drugs affecting intestinal secretions DYSPEPSIA AND GASTRO-OESOPHAGEAL REFLUX DISEASE 1.1.1 Antacids and simeticone Aluminium hydroxide capsules Co-magaldrox suspension Magnesium trisilicate Sodium citrate sachets Simeticone Simeticone (dimeticone) liquid ‘Infacol’ 1.1.2 Compound alginates and proprietary indigestion preparations Other compound alginate preparations ‘Gaviscon Advance’ suspension ‘Gaviscon Infant’ sachets ‘Gaviscon Advance’ tablets 1.2 ANTISPASMODICS AND OTHER DRUGS ALTERING GUT MOTILITY 1.2 Antispasmodics and other drugs altering gut motility Antimuscarinics Hyoscine butylbromide Other antispasmodics Mebeverine Peppermint water Motility stimulants Domperidone The tablets and oral solution are NOT bioequivalent please refer to BNF for accurate dosing. Extemporaneous product Unlicensed medicine Hospital only Hospital only when used for neonates and children MHRA Drug safety update Domperidone: small risk of serious ventricular arrhythmia and sudden cardiac death (May 2012) MHRA Drug safety update Domperidone: risks of cardiac Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -5- side effects – indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use (May 2014) MHRA Drug safety update Domperidone: risk of cardiac side effects– no longer available without prescription (Sept 2014) MHRA drug safety update Metoclopramide: risk of neurological adverse effects – restricted dose and duration of use (Aug 2013) Metoclopramide 1.3 ANTISECRETORY DRUGS AND MUCOSAL PROTECTANTS 1.3.1 H2 receptor antagonists Cimetidine Ranitidine 1.3.3 Chelates and complexes Sucralfate Sucralfate paste Extemporaneous product Unlicensed medicine Hospital only Tripotassium dicitratobismuthate ‘De-Noltab’ 1.3.4 Prostaglandin analogues Misoprostol 1.3.5 Proton pump inhibitors MHRA Drug safety update Proton pump inhibitors in long-term use: recent epidemiological evidence of increased risk of fracture (Apr 2012) MHRA Drug safety update Proton pump inhibitors in long-term use: reports of hypomagnesaemia (Apr 2012) MHRA Drug safety update Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus (Sept 2015) Gastroenterologists and Esomeprazole Gastrointestinal Surgeons only Full 8 week treatment course for severe oesophagitis to be supplied from the Trust GPs to prescribe maintenance proton pump inhibitor of their choice. For use in patients receiving Lansoprazole capsules concomitant clopidogrel only Lansoprazole orodispersible tablets Adult patients only For Nasogastric (NG) & Percutaneous Endoscopic Gastrostomy (PEG) tubes and patients with swallowing difficulties Omeprazole capsules For reducing risk of recurrent Omeprazole injection bleeding peptic ulcers post endoscopy and when nil by mouth Paediatric patients only Omeprazole ‘Mups’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -6- For Nasogastric (NG) & Percutaneous Endoscopic Gastrostomy (PEG) tubes and patients with swallowing difficulties only. Oral viscous budesonide Oral viscous budesonide ‘Ora-Blend SF’ 1.4 ESTH protocol for oral viscous budesonide ACUTE DIARRHOEA 1.4.2 Antimotility drugs Codeine phosphate Co-phenotrope Loperamide capsules/syrup Loperamide tablets 1.5 Paediatricians only For use in paediatric patients with endoscopically proven eosinophilic oesophagitis. Use with budesonide nebuliser solution to allow oral administration. Unlicensed medicine Hospital only High output stoma patients only, who cannot administer the contents of the capsules CHRONIC BOWEL DISORDERS 1.5 Chronic Bowel Disorders See NICE guidance for the treatment of Crohn’s disease (Oct 2012) NICE clinical guideline 152 Gastroenterologists only Acetarsol suppositories Unlicensed preparation, Hospital only 1.5.1 Aminosalicylates Balsalazide Mesalazine ‘Asacol’® ‘Octasa’® ‘Pentasa’® ‘Salofalk’® Mesalazine ‘Mezavant XL’® Olsalazine Sulfasalazine 1.5.2 Corticosteroids Budesonide, budesonide CR Hydrocortisone foam aerosol ‘Colifoam’ Prednisolone rectal foam Prednisolone retention enema ‘Predsol’ Beclometasone dipropionate ‘Clipper’® Gastroenterologists only st ‘Octasa’® brand 1 line for new patients nd 2 line for patients unresponsive to st 1 line options Gastroenterologists only Prescribe by brand name Gastroenterologists only Gastroenterologists only nd 2 line for ulcerative colitis patients who are unable to take aminosalicylates and prednisolone. Hospital only 1.5.3 Drugs affecting the immune response Gastroenterologists only, Crohn’s Azathioprine (see section 8.2.1) disease and ulcerative colitis Unlicensed indication Shared care guidance available for Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -7- NHS Surrey shared care Ciclosporin (see section 8.2.2) ® ® ‘Deximune ’, ‘Neoral ’, ® ‘Sandimmun ’ Mercaptopurine (see section 8.2.1) Methotrexate (see section 10.1.3) Tacrolimus ‘Adoport’®, ‘Advagraf’®, ‘Prograf’® specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Gastroenterologists only, ulcerative colitis Unlicensed indication, hospital only ‘Deximune’® 1st line for new patients Gastroenterologists only, Crohn’s disease and ulcerative colitis Unlicensed indication Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Gastroenterologists only, Crohn’s disease Unlicensed indication Gastroenterologists only, Ulcerative colitis, Unlicensed indication PbR exclusion Hospital only Prescribe by brand name MHRA Drug safety update Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) NHS Surrey shared care Weekly dose 2.5 mg tablets only NHS SWL shared care MHRA/CHM Drug Safety Update: Prescribe and dispense by brand name (Jun 2012) Prescribe by brand name NICE Clinical Guideline 166 Cytokine modulators Adalimumab Infliximab ‘Remicade’®, ‘Remsima’® Golimumab Vedolizumab Consultant Gastroenterologists only, use in accordance with NICE guidance for Crohn's disease (May 2010) and moderate to severe ulcerative colitis (Feb 2015) PbR exclusion Hospital only Consultant Gastroenterologists only, use in accordance with NICE guidance for Crohn's disease (May 2010),acute exacerbations of ulcerative colitis (Dec 2008) and moderate to severe ulcerative colitis (Feb 2015) PbR exclusion, hospital only ‘Remsima’® 1st line for new patients and new episodes of care Consultant Gastroenterologists only, use in accordance with NICE guidance for moderate to severe ulcerative colitis (Feb 2015) PbR exclusion Hospital only Consultant Gastroenterologists only, use in accordance with NICE guidance for treating moderately to severely active ulcerative colitis (June 2015), for treating moderately to severely active Crohn's disease after prior therapy (Aug 2015) PbR exclusion Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -8- NICE technology appraisal 187 NICE technology appraisal 329 NICE technology appraisal 187 NICE technology appraisal 163 NICE technology appraisal 329 Prescribe by brand name NICE technology appraisal 329 NICE technology appraisal 342 NICE technology appraisal 352 Hospital only 1.5.4 Food allergy Sodium cromoglicate 1.6 LAXATIVES See ESTH Management of constipation in children and young people 1.6.1 Bulk forming laxatives Ispaghula husk 1.6.2 Stimulant laxatives Bisacodyl Co-danthramer Docusate sodium capsules/liquid Docusate sodium enema ‘Norgalax Micro-enema’ Glycerol suppositories, BP Senna Sodium picosulfate elixir Terminally ill patients only Adult patients only 1.6.3 Faecal softeners Arachis oil enema 1.6.4 Osmotic laxatives Lactulose Magnesium hydroxide Magnesium hydroxide & liquid paraffin Phosphate enema Macrogol oral powder, compound (Macrogols 3350) ‘Movicol’ ‘Laxido’® Macrogols 3350 ‘Movicol Paediatric Plain’® Sodium citrate enema ‘Micralax Micro-enema’ Palliative Care and Care of the Elderly Clinicians only rd 3 line after unsuccessful treatment with a combination of softener & stimulant laxative, See Trust Inpatient laxative guidance for adult medical patients (June 2009) Use in accordance with Trust guidelines for the management of constipation in children and young people (Apr 2014) Paediatric patients only Use in accordance with Trust guidelines for the management of constipation in children and young people (Apr 2014) Paediatric patients only 1.6.5 Bowel cleansing preparations See Trust Guidance: Oral bowel cleansing agent prescription checklist ‘Klean-Prep’ Sodium picosulfate with magnesium citrate e.g.‘Picolax’, ‘CitraFleet’® nd 2 line in those patients unable to ‘Moviprep’® take ‘Picolax’® due to the risk of developing hypovolaemia and hyponatraemia, see Trust oral bowel cleansing agent prescription Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 -9- NICE clinical guideline 99 NICE clinical guideline 99 checklist 1.6.6 Peripheral opioid-receptor antagonists Palliative Care Consultants only Methylnaltrexone For opioid induced constipation after multiple therapies have failed. If treatment unsuccessful after a single dose it is not to be retried, if successful can be repeated intermittently when necessary. Hospital only 1.6.7 Other drugs used in constipation nd rd 2 /3 line Linaclotide Treatment to be reviewed after 4 weeks and discontinued if ineffective. Use in accordance with NICE Lubiprostone guidance for chronic isopathic constipation (July 2014) Palliative Care Consultants and Naloxegol Consultant Gastroenterologists only Use in accordance with NICE guidance for treating opioid-induced constipation (July 2015) Hospital only Use in accordance with NICE Prucalopride guidance for chronic constipation in women (Dec 2010) 1.7 LOCAL PREPARATIONS FOR ANAL AND RECTAL DISORDERS 1.7.1 Soothing haemorrhoidal preparations ‘Anusol’ or equivalent product ointment, cream, and suppositories 1.7.2 Compound haemorrhoidal preparations with corticosteroids ‘Anusol HC’ ointment, suppositories ‘Proctosedyl’ ointment, suppositories ‘Uniroid HC’ ointment 1.7.3 Rectal sclerosants Oily phenol injection Phenol in water 1.7.4 Management of anal fissures Diltiazem cream 2% Glyceryl trinitrate ointment 0.4% ‘Rectogesic’® Unlicensed medicine Hospital only Colorectal Specialists only nd 2 line for anal fissures when glyceryl trinitrate ointment not tolerated Unlicensed medicine, hospital only Colorectal Specialists and Gastroenterologists only For anal fissures Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 10 - NHS Surrey IBS algorithm NICE technology appraisal 318 NICE technology appraisal 345 NICE technology appraisal 211 1.8 STOMA CARE 1.8 Stoma care ‘Chiron Barrier Cream’ 1.9 DRUGS AFFECTING INTESTINAL SECRETIONS 1.9.1 Drugs affecting biliary composition and flow Ursodeoxycholic acid 1.9.2 Bile acid sequestrants Colestyramine Colesevelam Hydrochloride ‘Cholestagel’® Gastroenterologists only nd 2 line for bile acid diarrhoea when colestyramine is not tolerated. Unlicensed indication NHS Surrey Shared Care Administered orally for small bowel obstruction in accordance with Trust protocol. Surgeons only Unlicensed indication Hospital only Gastrografin Protocol 1.9.4 Pancreatin ‘Creon’ ‘Creon Micro’® Pancreolauryl test Gastrografin Gastrografin Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 11 - BNF SECTION 2 CARDIOVASCULAR SYSTEM NICE clinical guideline 172 – Myocardial Infarction: secondary prevention (Nov 2013) 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 Positive inotropic drugs Diuretics Anti-arrhythmic drugs Beta-adrenoceptor blocking drugs Hypertension and heart failure Nitrates, calcium-channel blockers, and other antianginal drugs Sympathomimetics Anticoagulants and protamine Antiplatelet drugs Stable angina, acute coronary syndromes, and fibrinolysis Antifibrinolytic drugs and haemostatics Lipid-regulating drugs Local sclerosants 2.1 POSITIVE INOTROPIC DRUGS 2.1.1 Cardiac glycosides Digoxin Digoxin-specific antibody 2.2 Digoxin specific antibody fragments ‘DigiFab’ Unlicensed medicine Epsom is a designated holding centre. Supplies kept in the fridge on C6 at St Helier and CCU at Epsom PbR exclusion, Hospital only DIURETICS 2.2.1 Thiazides and related diuretics Bendroflumethiazide (bendrofluazide) Paediatricians only Chlorothiazide suspension Unlicensed medicine, hospital only Indapamide, indapamide SR 2.2.2 Loop diuretics SLCSN Initiation and Titration of loop diuretics in adults with left ventricular systolic dysfunction- (Dec 2010) Bumetanide tablets (IV for resistant cases only) Furosemide (frusemide) 2.2.3 Potassium-sparing diuretics and aldosterone antagonists Amiloride Aldosterone antagonists Prescribing aldosterone antagonists in heart failure Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 12 - Eplerenone Use in accordance with Trust guidance on prescribing eplerenone and NICE guidance for secondary prevention in primary and secondary care for patients following a myocardial infarction (Nov 2013) NICE clinical guideline 172 MHRA Drug safety update Spironolactone and reninangiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia (Feb 2016) Spironolactone 2.2.4 Potassium-sparing diuretics with other diuretics Amiloride with bumetanide Co-amilofruse (2.5/20, 5/40) Co-amilozide (2.5/25, 5/50) 2.2.5 Osmotic diuretics Mannitol 10% and 20% 2.3 Unlicensed indication- Oral use of 20% mannitol for small bowel MRI ANTI-ARRHYTHMIC DRUGS 2.3.2 Drugs for arrhythmias Supraventricular arrhythmias Adenosine Dronedarone Initiation by Cardiologists only, use in accordance with NICE guidance for non-permanent atrial fibrillation (Aug 2010) NHS Surrey - Hospital only NHS Sutton & Merton - Prescribing to remain within the Trust for 6 months Supraventricular and ventricular arrhythmias Amiodarone Disopyramide Flecainide Procainamide On Cardiologist’s advice only Cardiologists only Unlicensed medicine, only available from special order manufacturers or specialist importing companies Hospital only Propafenone Ventricular arrhythmias Lidocaine (Lignocaine) injection 2% Lidocaine (Lignocaine) in glucose infusion 0.1%, 0.4% Mexiletine Unlicensed medicine, only available from special order manufacturers or specialist importing companies Hospital only Atrial fibrillation and diagnosis of Brugada Syndrome Consultant Cardiologists only Ajmaline See Trust Guidelines for Ajmaline Testing in patients with suspected Brugada Syndrome Unlicensed medicine Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 13 - NICE technology appraisal 197 MHRA Drug safety update Dronedarone: cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements (Oct 2011) NHS Surrey shared care Injection has been discontinued (Aug 2015) NHS Surrey shared care NHS Surrey shared care Isoprenaline injection (See section 2.7.1) 2.4 Consultant Cardiologists only See Trust Guidelines for Ajmaline Testing in patients with suspected Brugada Syndrome Unlicensed medicine Hospital only BETA-ADRENOCEPTOR BLOCKING DRUGS 2.4 Beta-adrenoceptor blocking drugs Atenolol 1st line for heart failure Bisoprolol Co-tenidone (50/12.5, 100/25) Esmolol Labetalol Metoprolol Propranolol Sotalol 2.5 HYPERTENSION AND HEART FAILURE SWL Traffic Light Guide to Blood Pressure Measurement- Sept 2014 SWL Managing Uncomplicated Hypertension- Sept 2014 2.5.1 Vasodilator antihypertensive drugs Diazoxide Hydralazine Consultant Vascular Surgeons only Iloprost Named patient supply Unlicensed medicine PbR exclusion Hospital only Unlicensed medicine, only available Sodium nitroprusside from special order manufacturers or specialist importing companies Hospital only 2.5.2 Centrally acting antihypertensive drugs Clonidine Extemporaneous product Clonidine suspension Unlicensed medicine Hospital only Methyldopa Nephrologists only Moxonidine 2.5.3 Adrenergic neurone blocking drugs Guanethidine (nerve block) Consultant Anaesthetists and Palliative Care Consultants only 2.5.4 Alpha-adrenoceptor blocking drugs Doxazosin (immediate release tablets only) Prazosin Phaeochromocytoma Unlicensed medicine Phentolamine Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 14 - 2.5.5 Drugs affecting the renin-angiotensin system MHRA Drug safety update ACE inhibitors and angiotensin-II receptor antagonists: recommendations on use during breastfeeding (May 2009) SLCSN Initiation and Titration of Angiotensin II Receptor Antagonists (ARB’s) in adults with left ventricular systolic dysfunction- (Dec 2010) SLCSN Initiation and Titration of Angiotensin-converting enzyme inhibitors in adults with left ventricular systolic dysfunction- (Dec 2010) 2.5.5.1 Angiotensin-converting enzyme inhibitors (ACE-Inhibitors) Captopril Captopril oral solution Lisinopril 1st line post myocardial infarction Ramipril 2.5.5.2 Angiotensin-II receptor antagonists (for patients intolerant of ACE inhibitors) Candesartan Diabetic and Renal patients only Irbesartan st 1 line Losartan Sacubitril Valsartan Entresto® Use in accordance with Trust NICE technology appraisal 388 guidelines and NICE guidance for treating symptomatic chronic heart For newly initiated patients please failure with reduced ejection fraction complete the Sacubitril Valsartan (April 2016) initiation forms 2.6 NITRATES, CALCIUM-CHANNEL BLOCKERS, AND OTHER ANTIANGINAL DRUGS 2.6.1 Nitrates Glyceryl trinitrate Glyceryl trinitrate spray Isosorbide mononitrate Isosorbide mononitrate MR ‘Elantan LA’ 2.6.2 Calcium-channel blockers Amlodipine Diltiazem MR 60mg, ‘Adizem’ SR and XL, and ‘Tildiem’ Retard and LA Nifedipine capsules, ‘Adalat’, ‘Nifedipress MR’ tablets Nifedipine tablets, ‘Adalat LA’ Nimodipine Electrocardiogram, theatres and discharge only Prescribe by brand name Twice daily administration Once daily administration Treatment of subarachnoid haemorrhage Verapamil, verapamil MR 2.6.3 Other antianginal drugs Ivabradine Consultant Cardiologists only, for patients intolerant/contraindicated to β-blockers, diltiazem, nitrates and nicorandil and for use in accordance with NICE guidance for the treatment of chronic heart failure (Nov 2012) NICE technology appraisal 267 Prescribing ivabradine in chronic heart failure NHS Surrey shared care - heart failure NHS Surrey shared care - angina MHRA Drug safety update Ivabradine: emerging clinical trial evidence of increased Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 15 - cardiovascular risk – carefully monitor for bradycardia (June 2014) MHRA Drug safety update Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects—new advice to minimise risk (Dec 2014) MHRA Drug safety update Nicorandil: gastrointestinal ulceration (Jun 2008) Nicorandil MHRA Drug safety update Patients swallowing the desiccant (Nov 2014) MHRA Drug safety update Nicorandil: now second-line treatment for angina; risk of ulcer complications (Jan 2016) Ranolazine Consultant Cardiologists only 4th line drug where the existing third and fourth line agents are contraindicated/ not tolerated Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details) 2.6.4 Peripheral vasodilators and related drugs Use in accordance with NICE Naftidrofuryl oxalate guidance for the treatment of intermittent claudication in people with peripheral arterial disease (May 2010) Gastroenterologists only, severe Pentoxifylline alcoholic hepatitis Unlicensed indication Hospital only 2.7 SYMPATHOMIMETICS 2.7.1 Inotropic sympathomimetics Dobutamine Dopamine Dopexamine Isoprenaline injection Unlicensed medicine for the treatment of ajmaline induced proarrhythmia, only available from special order manufacturers or specialist importing companies Hospital only Not for use in ITU. 2.7.2 Vasoconstrictor sympathomimetics Noradrenaline Phenylephrine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 16 - NHS Surrey shared care NICE technology appraisal 223 Postural hypotension Fludrocortisone Midodrine Unlicensed indication, hospital only nd 2 line after Fludrocortisone Hospital only for Sutton and Merton CCG’s NHS Surrey shared care 2.7.3 Cardiopulmonary resuscitation Adrenaline (epinephrine) Bupivacaine induced cardiac arrest Intralipid 20% Unlicensed indication, hospital only 2.8 ANTICOAGULANTS AND PROTAMINE 2.8.1 Parenteral anticoagulants Heparin Renal patients only Heparin Calcium Heparin Sodium Low molecular weight heparins (all hospital only) Patient safety alert – Harm from using Low Molecular Weight Heparins when contraindicated (Jan 2015) Prophylaxis and treatment of deep Dalteparin vein thrombosis/pulmonary embolism and anticoagulation in atrial fibrillation Renal patients only Tinzaparin Heparinoids Haematologists only in accordance Heparin Induced Danaparoid with Trust protocol Thrombocytopenia Protocol st 1 line (if available) for use in heparin induced thrombocytopenia Hospital only Argatroban Argatroban Hirudins Bivalirudin Heparin flushes Heparin flush 10units/ml (5ml) Taurolidine 1.36% / Cit 4% / Hep 500units/ml.’TauroLock- HEP500’® Epoprostenol Epoprostenol Haematologists only in accordance with Trust protocol nd 2 line for use in heparin induced thrombocytopenia Hospital only Heparin Induced Thrombocytopenia Protocol Use in accordance with NICE guidance for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (Jul 2011) Hospital only NICE technology appraisal 230 Must be prescribed in accordance with Trust guidelines Sodium chloride 0.9% is first line for maintaining patency of peripheral venous catheters st 1 line for maintaining patency of haemodialysis catheters Consultant Nephrologists only, for maintaining extra corporeal lines and ICU for haemofiltration PbR exclusion Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 17 - MHRA Drug safety update Bivalirudin: risks associated with incorrect dose (Jan 2008) Fondaparinux Fondaparinux sodium Use in accordance with Trust and NICE guidance for the early management of unstable angina and non-ST-segment-elevation myocardial infarction (Mar 2010) Hospital only Haematologists only in accordance with Trust protocol nd 2 line for use in heparin induced thrombocytopenia (unlicensed use) NICE clinical guideline 94 Heparin Induced Thrombocytopenia Protocol 2.8.2 Oral anticoagulants Use a single anticoagulant patient safety card for all anticoagulants including DOAC’s Acenocoumarol Phenindione MHRA Drug safety update Warfarin Warfarin: reports of calciphylaxis (July 2016) See the Trust Medicines Resource site for Notification of Initiation and Transfer of Care documents. Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 prior to initiating apixaban. MHRA Drug safety update Apixaban, dabigatran and rivaroxaban: risk of serious haemorrhage – clarified contraindications apply to all medicines (Oct 2013) MHRA Drug safety update Dabigatran: risk of serious haemorrhage – need for renal function testing (July 2012) MHRA Drug safety update Dabigatran: contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment – risk of thrombosis and haemorrhage (Mar 2013) Dabigatran etexilate Use in accordance with Trust and NICE technology appraisal 157 Dabigatran NICE guidance For the prevention of venous NICE technology appraisal 249 thromboembolism after hip or knee replacement surgery (Sep 2008) NICE technology appraisal 327 (Hospital only) For the prevention of stroke and For newly initiated atrial systemic embolism in atrial fibrillation patients please fibrillation (Mar 2012) complete the DOAC initiation For treatment and secondary forms prevention of recurrent DVT and PE (Dec 2014) For newly initiated VTE patients Contact Medicines Management please complete a one off drug Team on Ext: 701 6075/721 request form 4037/721 4038 prior to initiation Use in accordance with Trust Idarucizumab guidelines Reversing Direct Oral Anticoagulant-Associated Bleeding. Use of idarucizumab (Praxbind®) to be discussed and agreed with haematology consultant before use. Apixaban Use in accordance with NICE NICE technology appraisal 245 Apixaban guidance for the prevention of venous thromboembolism after hip NICE technology appraisal 275 or knee replacement surgery (Jan 2012) (Hospital only) NICE technology appraisal 341 For the prevention of stroke and systemic embolism in atrial For newly initiated atrial fibrillation (Feb 2013) fibrillation patients please For the treatment and secondary complete the DOAC initiation prevention of deep vein thrombosis forms and/or pulmonary embolism (June 2015) For newly initiated VTE patients Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 18 - Rivaroxaban Rivaroxaban Edoxaban Edoxaban Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 prior to initiation please complete a one off drug request form Use in accordance with Trust and NICE guidance For the prevention of venous thromboembolism after hip or knee replacement surgery (Apr 2009) (Hospital only) For the prevention of stroke and systemic embolism in atrial fibrillation (May 2012) For the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism (Jul 2012) For the treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism (Jun 2013) and for preventing adverse outcomes after acute management of acute coronary syndrome (March 2015) For patients undergoing cardioversion (June 2016) For the for the prevention of atherothrombotic events after an Acute Coronary Syndrome (Oct 2016) Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 prior to initiation NICE technology appraisal 170 Use in accordance with NICE guidance for treating and for preventing deep vein thrombosis and pulmonary embolism (Aug 2015) (Hospital only) For preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation (Sept 2015) Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 prior to initiation NICE technology appraisal 354 NICE technology appraisal 256 NICE technology appraisal 261 NICE technology appraisal 287 NICE technology appraisal 335 For newly initiated atrial fibrillation patients and patients to undergo cardioversion please complete the DOAC initiation forms For newly initiated VTE patients please complete a one off drug request form For newly initiated ACS patients please complete the DOAC initiation forms NICE technology appraisal 355 For newly initiated atrial fibrillation patients please complete the NOAC initiation forms For newly initiated VTE patients please complete a one off drug request form 2.8.3 Protamine sulfate Protamine sulfate 2.9 ANTIPLATELET DRUGS 2.9 Antiplatelet drugs SLCSN recommendations: Summary of antiplatelet options in cardiovascular disease (Sept 2014) E.C second line MHRA Drug safety update Aspirin soluble Aspirin: not licensed for primary prevention of thrombotic vascular disease (Oct 2009) Use in accordance with Trust SLCSN guidance on prescribing Clopidogrel st guidance 1 line after a transient clopidogrel in cardiac patientsischaemic attack (TIA) and NICE (Dec 2010) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 19 - guidance For the early management of unstable and non-ST-segmentelevation myocardial infarction (Mar 2010) For prevention of occlusive vascular events (Dec 2010) MHRA Drug safety update Clopidogrel: risk of acquired haemophilia (December 2013) MHRA Drug safety update Clopidogrel and proton pump inhibitors: interaction – updated advice (Apr 2010) NICE clinical guideline 94 Dipyridamole, Dipyridamole MR ‘Persantin Retard’ Dipyridamole with aspirin ‘Asasantin Retard’ Eptifibatide Prasugrel Ticagrelor Use in accordance with Trust nd guidance 2 line after a transient ischaemic attack (TIA) and NICE guidance For prevention of occlusive vascular events (Dec 2010) Use in accordance with NICE guidance for prevention of occlusive vascular events (Dec 2010) Initiation by Consultant Cardiologists only Use in accordance with Trust and NICE guidance for the early management of unstable and nonST-segment-elevation myocardial infarction (Mar 2010) Consultant Cardiologists only Use in accordance with Trust and NICE guidance for the treatment of acute coronary syndromes with percutaneous coronary intervention (Oct 2009,updated July 2014) Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details) Consultant Cardiologists only Use in accordance with NICE guidance for the treatment of acute coronary syndromes (Oct 2011) NICE technology appraisal 210 NICE technology appraisal 210 NICE technology appraisal 210 NICE technology appraisal 47 NICE clinical guideline 94 SLCSN Prescribing guidelines for Prasugrel for Acute Coronary Syndromes- (June 2010) NICE technology appraisal 182 NICE technology appraisal 317 NHS Surrey shared care MHRA Drug safety update Prasugrel: increased risk of bleeding – information on time of loading dose (January 2014) MHRA Drug safety update Prasugrel: rare but serious hypersensitivity reactions (May 2011) NICE technology appraisal 236 NHS Surrey shared care NHS SWL shared care Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 20 - 2.10 STABLE ANGINA, ACUTE CORONARY SYNDROMES, AND FIBRINOLYSIS 2.10.2 Fibrinolytic Drugs (Hospital only) For massive Pulmonary Embolism Alteplase (PE) – see Guidelines for PE in Management of Common Medical Emergencies Consultant Stroke physicians only, Alteplase for use in accordance with Trust and NICE guidance for the treatment of ischaemic stroke presenting within 4.5 hours of onset (Sep 2011) Streptokinase Catheter locking agent for Taurolidine 1.36% / Cit 4% / haemodialysis patients only Urokinase 5000units/ml. ‘TauroLock™-U25,000’ To clear blocked central line Urokinase 10,000units ‘Syner-KINASE’® NICE technology appraisal 264 2.11 ANTIFIBRINOLYTIC DRUGS AND HAEMOSTATICS 2.11 Antifibrinolytic drugs and haemostatics Tranexamic acid Extemporaneous product Tranexamic acid mouthwash Unlicensed medicine Hospital only Blood-related products (Hospital only) Obtain direct from Haematology Human prothrombin complex PbR exclusion concentrate ‘Beriplex’® Consultant Haematologists only Recombinant Coagulation FactorUse in accordance with Trust VIIa ‘NovoSeven’ protocol Obtain direct from Haematology PbR exclusion Consultant Radiologists only Thrombin Management of pseudoaneurysms Obtain direct from Radiology 2.12 LIPID-REGULATING DRUGS 2.12 Lipid-regulating drugs See Trust Guidance: Lipid Management for Primary and Secondary prevention of CVD (Sept 2014) Familial hyperlipidaemia guidance (Apr 2013) Statins See NICE guidance: Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (Jul 2014) NICE clinical guideline 181 MHRA Drug safety update Statins: class effects identified (Feb 2008) MHRA Drug safety update Statins: risk of hyperglycaemia and diabetes (Jan 2012) MHRA Drug safety update Simvastatin dose limitations with concomitant medicines (Oct 2012) Trust guidance update on simvastatin interactions (Nov 2013) Simvastatin interactions 1st line for primary and secondary MHRA Drug safety update Simvastatin prevention, in accordance with the Simvastatin: increased risk of Trust Lipid Management Guidelines myopathy at high dose (80mg) (May 2010) Use in accordance with the Trust MHRA Drug safety update Atorvastatin Lipid Management Guidelines Statins: interactions and updated Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 21 - advice for atorvastatin (Jan 2008) Pravastatin Rosuvastatin Bile acid sequestrants Colestyramine Colesevelam hydrochloride Ezetimibe Ezetimibe If potential for drug interactions, use in accordance with the Lipid Management Guidelines) Lipid specialists only rd th 3 or 4 line therapy Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details) NHS Surrey shared care Use in accordance with the Trust Lipid Management Guidelines and NICE guidance for treating primary heterozygous-familial and nonfamilial hypercholesterolaemia (Feb 2016) NICE technology appraisal 385 Fibrates MHRA Drug safety update Fibrates: new prescribing advice (Nov 2007) MHRA Drug safety update Fibrates: EMA concludes first-line treatment is not recommended (Dec 2010) Bezafibrate, bezafibrate MR Fenofibrate, fenofibrate MR Omega-3 fatty acid compounds Lipid specialist only Omega 3 acid ethyl esters For patients with severe ‘Omacor’® hypertriglyceridaemia Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors Use in accordance with NICE NICE technology appraisal 393 Alirocumab guidance for treatment of primary hypercholesterolaemia or mixed dyslipidaemia in adults (June 2016) PbR exclusion Hospital only Use in accordance with NICE NICE technology appraisal 394 Evolocumab guidance for treatment of primary hypercholesterolaemia or mixed dyslipidaemia in adults (June 2016) PbR exclusion Hospital only 2.13 LOCAL SCLEROSANTS 2.13 Local sclerosants Sodium tetradecyl sulfate ‘FibroVein’® Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 22 - BNF SECTION 3 RESPIRATORY SYSTEM 3.1 3.2 3.3 Bronchodilators Corticosteroids Cromoglicate and related therapy, leukotriene receptor antagonists, and phosphodiesterase type-4 inhibitors 3.4 Antihistamines, hyposensitisation, and allergic emergencies 3.5 Respiratory stimulants and pulmonary surfactants 3.6 Oxygen 3.7 Mucolytics 3.8 Aromatic inhalations 3.9 Cough preparations 3.10 Systemic nasal decongestants 3.11 Antifibrotics 3.12 Agents for use in Pleurodesis 3.1 BRONCHODILATORS Bronchodilators Use in accordance with NICE guidance Chronic asthma (Mar 2008) NICE technology appraisal 138 COPD (Jul 2011) NICE clinical guideline 101 Trust COPD guidance (June 2016) COPD guidance 3.1.1 Adrenoceptor agonists 3.1.1.1 Selective beta2 agonists Short acting beta2 agonists MHRA Drug safety update Short-acting beta2-agonists: myocardial ischaemia (Dec 2007) Salbutamol Salbutamol 100 microgram inhaler Metered dose (aerosol) inhaler (also Easi-breathe®) Salbutamol 2.5mg/2.5ml nebuliser solution Nebules Salbutamol 5mg/2.5ml nebuliser solution Salbutamol 500 microgram/1ml injection Injection Salbutamol 5mg/5ml injection Salbutamol 2mg/5ml syrup Oral liquid Terbutaline Terbutaline 500 mcg Turbohaler® Dry powder inhaler Terbutaline 5mg/2ml nebuliser solution Nebules Terbutaline 500 microgram/1ml injection Injection Long acting beta2 agonists CHM advice for the management of chronic asthma – Formoterol and salmeterol should only be used in patients who regularly use an inhaled corticosteroid and introduced at a low dose and effect monitored before considering dose increase MHRA Drug safety update Long-acting beta2-agonists: reminder for use in adults and children (Sep 2010) Formoterol (eformoterol) Formoterol 12 microgram capsules with Dry powder inhaler Paediatricians and Respiratory inhaler device Clinicians only Formoterol 6 microgram Turbohaler® ‘Oxis’® Formoterol 12 microgram Turbohaler® ‘Oxis’® Salmeterol Salmeterol 25 microgram inhaler Metered dose (aerosol) inhaler Salmeterol 50 microgram Accuhaler® Dry powder inhaler 3.1.1.2 Other adrenoceptor agonists Ephedrine injection Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 23 - 3.1.2 Antimuscarinic bronchodilators Aclidinium bromide Aclidinium 322 microgram inhaler Glycopyrronium Glycopyrronium 50 microgram capsules & Breezhaler® Ipratropium bromide Ipratropium 20 microgram inhaler Ipratropium 250 micrograms/ml nebuliser solution Ipratropium 500microgram/2ml nebuliser solution Tiotropium Tiotropium 18 microgram capsules & Handihaler® Tiotropium 2.5 micrograms per 1 dose Spiriva Respimat® Dry powder inhaler Dry powder inhaler Metered dose (aerosol) inhaler Nebules Dry powder inhaler Use in accordance with Trust guidance for prescribers, Managing stable COPD in adults (June 2016) and NICE guidance Soft mist MDI MHRA Drug safety update Tiotropium: safety studies of Spiriva Respimat (Nov 2010) MHRA Drug safety update Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial (Feb 2015) Umeclidinium Umeclidinium Incruse Ellipta® Dry powder inhaler 3.1.3 Theophylline Aminophylline IV and ‘Phyllocontin Continus’ Theophylline ‘Nuelin SA’, ‘Slo-Phyllin’®, ‘Uniphyllin Continus’® Caffeine Citrate Neonatal unit only Unlicensed medicine Hospital only 3.1.4 Compound bronchodilator preparations Aclidinium/formoterol Dry powder inhaler Aclidinium 340micrograms with formoterol fumarate 12micrograms ‘Duaklir Genuair’® Use in accordance with Trust guidance for prescribers, Managing stable COPD in adults (June 2016) Glycopyrronium/indacaterol Dry powder inhaler Glycopyrronium 43micrograms with Use in accordance with Trust indacaterol 85micrograms ‘Ultibro guidance for prescribers, Breezhaler’® Managing stable COPD in adults (June 2016) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 24 - Prescribe by brand name Patients should be maintained on the brand they have been stabilised on Prescribe by brand name Patients should be maintained on the brand they have been stabilised on MHRA Drug safety update Caffeine citrate: two products of different strengths are available. Care must be taken with dosing as the two products are not equivalent (Jun 2012) Ipratropium/salbutamol Ipratropium 500microgram with salbutamol 2.5mg/2.5ml nebuliser solution ‘Combivent’® Tiotropium/olodaterol Tiotropium 2.5 microgram with olodaterol 2.5 microgram ‘Spiolto Respimat®’ Umeclidinium/vilanterol Umeclidinium 55micrograms with vilanterol 22micrograms inhaler ‘Anoro Ellipta’® Nebules Outpatients and discharge only Soft mist MDI Use in accordance with Trust guidance for prescribers, Managing stable COPD in adults (June 2016) Dry powder inhaler Use in accordance with Trust guidance for prescribers, Managing stable COPD in adults (June 2016) 3.1.5 Peak flow meters, inhaler devices and nebulisers Peak flow meters Outpatients and discharge for Peak flow meters new patients only standard and low range Drug delivery devices NICE guidance: Inhaler devices for children (under 5) with chronic asthma (Aug 2000) NICE technology appraisal 10 and older children (Mar 2002) NICE technology appraisal 38 Respiratory Clinicians only ‘Able Spacer’® with/without infant, child and adult mask ‘Volumatic’® ‘Volumatic’® with paediatric mask ‘Aerochamber® Plus’ Standard device (blue) with/without mask Only on request of the Haleraid Respiratory nurses Nebuliser diluent Sodium chloride 0.9% 3.2 CORTICOSTEROIDS 3.2 Corticosteroids Use in accordance with NICE guidance Chronic asthma (Mar 2008) NICE technology appraisal 138 Asthma (in children) (Nov 2007) NICE technology appraisal 131 COPD (Jul 2011) NICE clinical guideline 101 MHRA Drug safety update Inhaled corticosteroids: pneumonia (Oct 2007) MHRA Drug safety update Inhaled and intranasal corticosteroids: risk of psychological and behavioural side effects (Sep 2010) Beclometasone CFC-free inhalers are not interchangeable. Prescribe by brand name Beclometasone 50 microgram inhaler Metered dose (aerosol) inhaler ‘Clenil Modulite’® st 1 line Beclometasone 100 microgram inhaler ‘Clenil Modulite’® Beclometasone 200 microgram inhaler ‘Clenil Modulite’® Beclometasone 250 microgram inhaler ‘Clenil Modulite’® Note: Qvar® is approximately twice as potent as Clenil Modulite® Prescribe by brand name Beclometasone 50 microgram Breath-actuated (aerosol) ‘Qvar’® Easi-breathe® inhaler Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 25 - Initiation by respiratory clinicians only nd 2 line for patients requiring a breath activated device only Compound preparations (beclometasone/formoterol) Beclometasone 100mcg and formoterol 6 Metered dose (aerosol) inhaler microgram inhaler ‘Fostair’® Beclometasone 100mcg and formoterol 6 Dry powder inhaler microgram inhaler ‘Fostair NEXThaler’® Beclometasone 200mcg and formoterol 6 Metered dose (aerosol) inhaler microgram inhaler ‘Fostair’® Beclometasone 200mcg and formoterol 6 Dry powder inhaler microgram inhaler ‘Fostair NEXThaler’® Beclometasone 100 microgram ‘Qvar’® Easi-breathe® Budesonide Budesonide 100 microgram Turbohaler® Dry powder inhaler ‘Pulmicort’® Budesonide 200microgram Turbohaler® ‘Pulmicort’® Budesonide 400microgram Turbohaler® ‘Pulmicort’® Budesonide 500microgram/2ml nebuliser Nebules solution Budesonide 1mg/2ml nebuliser solution Compound preparations (budesonide/formoterol) Budesonide 100 microgram and formoterol Dry powder inhaler 6 microgram Turbohaler® ‘Symbicort’® 100/6 Budesonide 200 microgram and formoterol 6 microgram Turbohaler® ‘Symbicort’® 200/6 Budesonide 400 microgram and formoterol 12 microgram Turbohaler® ‘Symbicort’® 400/12 Budesonide 160 microgram and formoterol Use in preference to 4.5 micrograms inhaler ‘Duoresp Symbicort® for new adult Spiromax’® patients Budesonide 320 microgram and formoterol Use in preference to 9 micrograms inhaler ‘Duoresp Symbicort® for new adult Spiromax’® patients Fluticasone propionate Fluticasone propionate 50 microgram inhaler Fluticasone propionate 125 microgram inhaler Fluticasone propionate 250 microgram inhaler Metered dose (aerosol) inhaler Fluticasone propionate 50 microgram Dry powder inhaler Accuhaler® Fluticasone propionate 100 microgram Accuhaler® Fluticasone propionate 250 microgram Accuhaler® Fluticasone propionate 500 microgram Accuhaler® Compound preparations (fluticasone/salmeterol) Fluticasone 50 microgram and salmeterol Metered dose (aerosol) inhaler 25 microgram inhaler ‘Seretide® 50 Evohaler® Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 26 - Prescribe by brand name Prescribe by brand name Asthma only Prescribe by brand name Prescribe by brand name Asthma only ‘Symbicort’® 200/6 ‘Symbicort’® 400/12 Use in accordance with Trust guidance for prescribers, Combination steroid inhalers for COPD management in adults – (June 2016) and NICE guidance Prescribe by brand. Fluticasone 125 microgram and salmeterol 25 microgram inhaler ‘Seretide® 125 Evohaler® Fluticasone 250 microgram and salmeterol 25 microgram inhaler ‘Seretide® 250 Evohaler® Fluticasone 100 microgram and salmeterol Dry powder inhaler Seretide® 500 Accuhaler® 50 microgram Accuhaler® ‘Seretide® 100 Accuhaler® Only Seretide device licensed Fluticasone 250 microgram and salmeterol for COPD Use in accordance with Trust 50 microgram Accuhaler® ‘Seretide® 250 Accuhaler® guidance for prescribers, Fluticasone 500 microgram and salmeterol Managing stable COPD in adults – (June 2016) and NICE 50 microgram inhaler ‘Seretide® 500 Accuhaler® guidance Compound preparations (fluticasone/formoterol) Fluticasone 50 microgram and formoterol 5 Metered dose (aerosol) inhaler microgram inhaler Flutiform® 50mcg/5mcg inhaler Fluticasone 125 microgram and formoterol 5 microgram inhaler Flutiform® 125mcg/5mcg inhaler Fluticasone 250 microgram and formoterol 10 microgram inhaler Flutiform® 250mcg/10mcg inhaler Compound preparations (fluticasone furoate/vilanterol) Fluticasone 92 microgram and vilanterol 22 Dry powder inhaler For COPD only micrograms inhaler Relvar Ellipta® 3.3 CROMOGLICATE AND RELATED THERAPY AND LEUKOTRIENE RECEPTOR ANTAGONISTS AND PHOSPHODIESTERASE TYPE-4 INHIBITORS 3.3.1 Cromoglicate and related therapy Nedocromil sodium 3.3.2 Leukotriene receptor antagonists Paediatricians & Respiratory Montelukast Clinicians only Dermatologists and Immunologists for urticaria (unlicensed indication). Hospital only for this indication. 3.4 ANTIHISTAMINES, HYPOSENSITISATION, AND ALLERGIC EMERGENCIES 3.4.1 Antihistamines Non-sedating antihistamines Cetirizine Unlicensed doses to be prescribed by Immunology only in accordance with the BSACI guidelines(2015) Fexofenadine Loratadine Sedating antihistamines Alimemazine (trimeprazine) Chlorphenamine (chlorpheniramine) For serotonin syndrome only Cyproheptadine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 27 - For existing patients only if used for COPD Seretide® 250 and 500 Accuhaler for existing patients only if used for COPD Not licensed for COPD MHRA Drug Safety Update The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation (April 2015) Hydroxyzine Ketotifen Promethazine hydrochloride Paediatric patients only 3.4.2 Allergen immunotherapy Available for Consultant Immunologists only (supplies to be obtained from Skin Prick Tests Product Manufacturer Allergy Therapeutics skin prick Allergy Therapeutics testing solutions Alyostal Stallergenes Alutard ALK Allergopharma Allergopharma/Diagenics Penicillin testing kit Diater Soluprick Allergy Therapeutics Inmunotek Biodiagnostics Sublingual immunotherapy Consultant Immunologists only Sublingual immunotherapy Unlicensed medicine. ‘Oralvac’® Hospital only Bee and wasp allergen extracts Use in accordance with NICE Bee venom extract ‘Pharmalgen’® guidance for the treatment of bee and wasp venom allergy (Feb 2012) Hospital only Use in accordance with NICE Wasp allergen extract guidance for the treatment of bee ‘Pharmalgen’® and wasp venom allergy (Feb 2012) Hospital only Grass and tree pollen extracts Pollinex® Consultant Immunologists only Sublingual immunotherapy Unlicensed medicine. ‘Staloral’® Hospital only Consultant Immunologists only Sublingual immunotherapy Hospital only ‘Grazax’® Omalizumab Use in accordance with NICE Omalizumab guidance for severe persistent allergic asthma (Apr 2013), and for previously treated chronic spontaneous urticaria (June 2015) PbR exclusion Hospital only 3.4.3 Allergic emergencies Anaphylaxis Adrenaline (epinephrine) 1 in 1,000 and 1 in 10,000 injection Adrenaline (epinephrine) ® Auto-injector ‘Jext’®, Emerade , Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 28 - Pharmacy) Unlicensed medicines Hospital only NICE technology appraisal 246 NICE technology appraisal 246 NICE technology appraisal 278 NICE technology appraisal 339 MHRA Drug safety update Omalizumab: potential risk of arterial thrombotic events (Feb 2011) Prescribe by brand name Epipen’® and ‘EpiPen junior’® Angioedema C1 Esterase Inhibitor ‘Berinert’® MHRA Drug safety update Adrenaline auto-injector advice for patients (May 2014) PbR exclusion Hospital only Blood product – Patient and product details required for tracking purposes 1500unit vial for patient selfadministration only. Not for use in Hospital. Icatibant ‘Firazyr’® 3.5 PbR exclusion Hospital only RESPIRATORY STIMULANTS AND PULMONARY SURFACTANTS 3.5.1 Respiratory stimulants Doxapram Hospital only 3.5.2 Pulmonary surfactants Poractant alfa PbR exclusion, Hospital only 3.6 OXYGEN Patient Safety Alert Risk of severe harm and death from unintentional interruption of non-invasive ventilation (Feb 2015) Medical helium 79% and oxygen 21% ‘Heliox’® Oxygen 3.7 MUCOLYTICS Carbocisteine Hypertonic sodium chloride nebuliser solution 3%, 7% Mannitol dry powder for inhalation N-acetylcysteine tablets Dornase alfa Dornase alfa 3.8 Respiratory and Neurology Clinicians only For use in cystic fibrosis (CF), and bronchiectasis in non-CF patients Use in accordance with NICE guidance for cystic fibrosis (Nov 2012) (PbR exclusion, Hospital only) Respiratory Consultants only For patients with Idiopathic Pulmonary Fibrosis ONLY as part of dual therapy with prednisolone Unlicensed medicine Hospital only Consultant Paediatricians only for Cystic Fibrosis PbR exclusion, Hospital only AROMATIC INHALATIONS Benzoin tincture compound, BP Menthol & eucalyptus inhalation, BP Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 29 - NICE clinical guideline 42 NICE technology appraisal 266 3.9 COUGH PREPARATIONS 3.9.1 Cough suppressants Codeine phosphate linctus, BP MHRA Drug safety update Codeine for cough and cold: restricted use in children (April 2015) Pholcodine linctus (sugar free) 3.9.2 Demulcent and expectorant and cough preparations Simple linctus, BP 3.10 Systemic nasal decongestants MHRA Drug safety update Pseudoephedrine and ephedrine: update on managing risk of misuse in the UK (Sept 2015) Pseudoephedrine 3.11 Antifibrotic Use in accordance with NICE guidance for the treatment of Idiopathic Pulmonary Fibrosis (Apr 2013) PbR exclusion Hospital only Pirfenidone 3.12 Agents for use in pleurodesis Doxycycline injection ® Sterile talc ‘Steritalc ’ Respiratory consultants only for pleurodesis Hospital only Respiratory consultants only for pleurodesis Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 30 - NICE technology appraisal 282 BNF SECTION 4 CENTRAL NERVOUS SYSTEM 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 Hypnotics and anxiolytics Drugs used in psychoses and related disorders Antidepressant drugs CNS stimulants and drugs used for attention deficit hyperactivity disorder Drugs used in the treatment of obesity Drugs used in nausea and vertigo Analgesics Antiepileptic drugs Drugs used in parkinsonism and related disorders Drugs used in substance dependence Drugs for dementia EPSOM SITE FOLLOW SURREY & BORDERS PARTNERSHIP NHS TRUST FORMULARY ST HELIER SITE FOLLOW SOUTH WEST LONDON AND ST GEORGE’S MENTAL HEALTH TRUST FORMULARY 4.1 HYPNOTICS AND ANXIOLYTICS 4.1.1 Hypnotics Hypnotics should only be prescribed for use PRN (when necessary) and patients must not be discharged on hypnotics unless already initiated on therapy prior to admission. Benzodiazepines Nitrazepam Temazepam CD Patients admitted on therapy only Drugs and Driving Law March 2015 Zaleplon, zolpidem and zopiclone First line short term night sedation NICE technology appraisal 77 Zopiclone Chloral and derivatives (BNF less suitable for prescribing) MHRA Drug safety update Chloral hydrate: not first-line option for insomnia (Jun 2009) Chloral hydrate Unlicensed medicine Chloral hydrate 500mg/5ml liquid Hospital only Cloral betaine Clomethiazole Drug and alcohol team only Clomethiazole (Chlormethiazole) Antihistamines Promethazine hydrochloride Melatonin st 1 Line Melatonin ‘Circadin MR’ ® Paediatricians only Unlicensed indication nd 2 Line Prescribe by brand name Melatonin 5mg/5ml Oral solution Paediatricians only ‘KidNaps’® Unlicensed medicine NICE clinical guideline 53 Melatonin 3mg capsules ‘Biomelatonin’® For paediatric sleep EEG clinic Unlicensed medicine Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 31 - NHS Surrey Shared Care for Persistent Sleep Disorders in Children over 3 years old with Neurodevelopmental Disorders Prescribe by brand name 4.1.2 Anxiolytics Benzodiazepines Diazepam Drugs and Driving Law March 2015 Drugs and Driving Law March 2015 Lorazepam Alcohol withdrawal Chlordiazepoxide capsules Diazepam 4.2 See guidelines for Alcohol Withdrawal in the ‘Management of Common Medical Emergencies’ See guidelines for Alcohol Withdrawal in the ‘Management of Common Medical Emergencies’ Drugs and Driving Law March 2015 DRUGS USED IN PSYCHOSES AND RELATED DISORDERS 4.2.1 Antipsychotic drugs (refer to relevant Mental Health Trust Formulary) MHRA Drug safety update Antipsychotics: use in elderly people with dementia (Mar 2009) MHRA Drug safety update Antipsychotics: risk of venous thromboembolic events (Jun 2009) MHRA Drug safety update Antipsychotics: use during third trimester of pregnancy and extrapyramidal effects or withdrawal symptoms in newborns (Sep 2011) MHRA Drug safety update Antipsychotics: initiative to reduce prescribing to older people with dementia (May 2012) First-generation antipsychotic drugs Chlorpromazine Haloperidol Trifluoperazine Second-generation antipsychotic drugs MHRA Drug safety update Atypical (second-generation) antipsychotics: reminder to monitor and manage weight, glucose and lipid levels (Apr 2011) Use in accordance with Rapid NICE technology appraisal 213 Aripiprazole Tranquillisation Policy and NICE guidance for the treatment of NICE technology appraisal 292 schizophrenia in people aged 15 to 17 years ((Jan 2011) and NICE guidance for the treatment of moderate to severe manic episodes in adolescents with bipolar disorder (Jul 2013) Restricted to patients registered with NICE clinical guideline 178 Clozapine Clozapine patient monitoring service Hospital only NICE guidance for the NICE clinical guideline 155 treatment of schizophrenia and psychosis (Mar 2009) and schizophrenia in children and young people (Jan 2013) (unlicensed indication) Restricted to patients registered with NICE clinical guideline 178 Clozapine suspension Clozapine patient monitoring service Hospital only NICE clinical guideline 155 NICE guidance for the treatment of schizophrenia and psychosis (Mar 2009) and schizophrenia in children and young people (Jan 2013) (unlicensed indication) Initiation by Consultant Psychiatrists NICE clinical guideline 38 Olanzapine only NICE guidance for the management of bipolar disorder (Jul 2006) Use in accordance with Rapid NICE clinical guideline 38 Quetiapine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 32 - Quetiapine MR Risperidone Tranquillisation Policy and NICE guidance NICE guidance for the management of bipolar disorder (Jul 2006) Existing patients only in accordance with Mental Health Trust Formulary NICE guidance for the management of bipolar disorder (Jul 2006) NICE guidance for the management of antisocial behaviour and conduct disorders in children and young people (Mar 2013) (Unlicensed indication) NICE clinical guideline 38 NICE clinical guideline 158 MHRA Drug safety update Risperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery (Nov 2013) 4.2.2 Antipsychotic depot injections (refer to relevant Mental Health Trust Formulary) 4.2.3 Antimanic drugs (refer to relevant Mental Health Trust Formulary) Carbamazepine Carbamazepine Valproate NICE guidance for the management Valproic acid ‘Depakote’ of bipolar disorder (Jul 2006) NICE clinical guideline 38 MHRA Drug safety update Sodium valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated due to neurodevelopmental delay and/or congenital malformations (January 2015) Lithium – Preparations vary widely in bioavailability prescribe by brand name. Patients should be maintained on the brand they have been stabilised on (Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details) NICE guidance for the management NICE clinical guideline 38 Lithium carbonate tablets of bipolar disorder (Jul 2006) (‘Priadel’®, ‘Camcolit’®) Lithium citrate liquid 1018mg/5ml (10.8mmol/5ml equivalent to 400mg Lithium Carbonate, refer to relevant Mental Health Trust Formulary) 4.3 NICE guidance for the management of bipolar disorder (Jul 2006) NICE clinical guideline 38 ANTIDEPRESSANT DRUGS 4.3 Antidepressant drugs MHRA Drug safety update Antidepressants: risk of fractures (May 2010) Anxiety disorders NICE guidance for the treatment of NICE clinical guideline 113 Sertraline generalised anxiety and panic disorder in adults (Jan 2011) NICE guidance for the treatment of NICE clinical guideline 113 Imipramine panic disorder in adults (Jan 2011) Unlicensed indication Use in accordance with NICE NICE clinical guideline 113 Clomipramine guidance for the treatment of panic disorder in adults (Jan 2011) Unlicensed indication Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 33 - Pregabalin NICE guidance for the treatment of generalised anxiety and panic disorder in adults (Jan 2011) 4.3.1 Tricyclic and related antidepressant drugs Tricyclic antidepressants Amitriptyline Dosulepin (dothiepin) Imipramine Lofepramine Tricyclic-related antidepressants Trazodone NICE clinical guideline 113 MHRA Drug safety update Dosulepin: measures to reduce risk of fatal overdose (Dec 2007) Initiation by Consultant with specialist interest in behavioural and psychological symptoms of dementia (Short term only) 4.3.2 Monoamine-oxidase inhibitors (MAOIs) (refer to relevant Mental Health Trust Formulary) 4.3.3 Selective serotonin re-uptake inhibitors MHRA Drug safety update SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn (May 2010) Maximum dose = 40mg MHRA Drug safety update Citalopram Maximum dose in patients > 65 Citalopram and escitalopram: QT years or hepatic impairment = 20mg interval prolongation—new maximum daily dose restrictions (including in elderly patients), contraindications, and warnings (Dec 2011) MHRA Drug safety update Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use (July 2016) MHRA Drug safety update Fluoxetine: possible small risk of congenital cardiac defects (Mar 2010) Fluoxetine Paroxetine Sertraline Vortioxetine For use in accordance with NICE guidance for major depressive episodes (Nov 2015) NICE technology appraisal 367 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy 4.3.4 Other antidepressant drugs (refer to relevant Mental Health Trust Formulary) Initiation by Consultant Psychiatrists Mirtazapine only To be initiated and maintained under Venlafaxine specialist supervision in accordance with NICE guidance For use in accordance with NICE NICE technology appraisal 367 Vortioxetine guidance for treating major depressive episodes (Nov 2015) The Trust will not initiate treatment but it will be available Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 34 - for use for patients admitted on therapy. 4.4 CNS STIMULANTS AND DRUGS USED FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER 4.4 CNS stimulants and drugs used for attention deficit hyperactivity disorder Use in accordance with NICE guidance for attention deficit hyperactivity disorder (Mar 2006) NICE technology appraisal 98 NICE guidance for the management of antisocial behaviour and conduct disorders in children and young people (Mar 2013) NICE clinical guideline 158 NICE guidance for attention deficit hyperactivity disorder: diagnosis and management (Feb 2016) NICE clinical guideline 72 Consultant Paediatricians for ADHD MHRA Drug safety update Atomoxetine only in patients unresponsive or Atomoxetine: increases in blood intolerant of methylphenidate only pressure and heart rate—new Shared care guidance available for contraindications, warnings, and specific CCGs – Contact Medicines advice for monitoring (Jan 2012) Management Team on Ext: 701 6075/721 4037/721 4038 for further MHRA Drug safety update details) Atomoxetine: risk of psychotic or manic symptoms (Mar 2009) Drugs and Driving Law March Dexamfetamine (dexamphetamine) 2015 CD Consultant Paediatricians, for ADHD NHS Surrey shared care Lisdexamfetamine CD only.Second line. Surrey patients only Drugs and Driving Law March Shared care guidance available for 2015 specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Consultant Paediatricians, for ADHD MHRA Drug safety update Methylphenidate immediate and only Methylphenidate: updated sustained release Shared care guidance available for guidance on safe and effective CD specific CCGs – Contact Medicines use in ADHD (Mar 2009) Management Team on Ext: 701 6075/721 4037/721 4038 for further details Consultant Neurologists only NHS Sutton and Merton shared Modafinil Shared care guidance available for care specific CCGs – Contact Medicines Management Team on Ext: 701 NHS Surrey shared care 6075/721 4037/721 4038 for further details MHRA Drug safety update Modafinil: now restricted to narcolepsy (Mar 2011) 4.5 DRUGS USED IN THE TREATMENT OF OBESITY 4.5.1 Anti-obesity drugs acting on the gastro-intestinal tract Use in accordance with NICE Orlistat guidance for obesity (Dec 2006) NICE clinical guideline 43 MHRA Drug safety update Orlistat: theoretical interaction with antiretroviral HIV medicines (Mar 2014) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 35 - 4.6 DRUGS USED IN NAUSEA AND VERTIGO 4.6 Drugs used in nausea and vertigo Antihistamines Cinnarizine st 1 line in the management of opioid Cyclizine induced & postoperative nausea & vomiting Promethazine hydrochloride Promethazine teoclate Phenothiazines and related drugs Palliative Care Clinicians only Levomepromazine (methotrimeprazine) Palliative Care Clinicians only Levomepromazine 6mg tablets Unlicensed medicine Hospital only Prochlorperazine Domperidone and metoclopramide Hospital only when used for neonates Domperidone and children MHRA Drug safety update Domperidone: small risk of serious ventricular arrhythmia and sudden cardiac death (May 2012) MHRA Drug safety update Domperidone: risks of cardiac side effects – indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use (May 2014) MHRA Drug safety update Domperidone: risk of cardiac side effects– no longer available without prescription (Sept 2014) MHRA drug safety update Metoclopramide: risk of neurological adverse effects – restricted dose and duration of use (Aug 2013) Metoclopramide 5HT3-receptor antagonists Ondansetron Oncology/Haematology/post-op patients only Hospital only MHRA Drug safety update Ondansetron: risk of QTc prolongation – important new intravenous dose restriction (Aug 2012) MHRA Drug safety update Ondansetron for intravenous use: dose-dependent QT interval prolongation—new posology (Jul 2013) Neurokinin-receptor antagonists Aprepitant Use in accordance with London Cancer New Drugs Group Antiemetic Guidelines for Adult Patients Receiving Chemotherapy and Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 36 - London Cancer New Drugs Group Antiemetic Guidelines for Adult Patients Receiving Chemotherapy and Radiotherapy Radiotherapy (March 2016) Cannabinoid Nabilone Hyoscine Hyoscine hydrobromide tablets Hyoscine hydrobromide patches Oncologists/Haematologists/Palliative Care Clinicians only Hospital only For excessive secretions Unlicensed indication, hospital only Other Drugs for Meniere’s disease Betahistine dihydrochloride 4.7 ANALGESICS NICE guidance for Spinal injury: assessment and initial management (Feb 2016) NICE clinical guideline 41 4.7.1 Non-opioid analgesics and compound analgesic preparations Non-opioid analgesic preparations Aspirin EC Second line Aspirin Guidelines for the administration Paracetamol of paracetamol Use in accordance with Trust pain Guidelines for the administration Paracetamol intravenous infusion guidance of paracetamol ‘Perfalgan’® MHRA Drug safety update Intravenous paracetamol (Perfalgan®): risk of accidental overdose, especially in infants and neonates (Jul 2010) Compound analgesic preparations containing paracetamol Co-codamol (codeine 8mg, paracetamol 500mg) Co-codamol (codeine 30mg, paracetamol 500mg) Co-dydramol (dihydrocodeine 10mg, paracetamol 500mg) NSAIDs – see 10.1.1 4.7.2 Opioid analgesics Drugs and Driving Law March 2015: blood concentrations limits set for certain controlled drugs Sublingual tablets only Buprenorphine CD nd 2 line, see Trust Guidelines for the Buprenorphine patches CD use of Transdermal Opioid Patches BuTrans® patches remove after 7 days and Transtec® patches after 96 hours MHRA Drug safety update Codeine phosphate Codeine for analgesia: restricted use in children because of reports of morphine toxicity (Jul 2013) Codeine phosphate injection CD Diamorphine CD Palliative Care Clinicians only Diamorphine for topical use with Unlicensed indication Intrasite gel CD Hospital only Paediatric A&E patients in NICE clinical guideline NG39 Diamorphine for intranasal use CD accordance with Trust protocol For use in accordance with NICE NICE clinical guidelines NG41 guidance for major trauma and spinal injuries Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 37 - Dihydrocodeine tartrate Dihydrocodeine tartrate injection CD Fentanyl CD Unlicensed indication Hospital only Immediate and sustained release tablets Injection, pre-filled syringe, patches, nasal spray and sublingual tablets MHRA Drug safety update Transdermal fentanyl patches: reminder of potential for lifethreatening harm from accidental exposure, especially in children (Jul 2014) MHRA Drug safety update Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure and inappropriate use (Sep 2008) Sublingual and patch formulations must be prescribed by brand Fentanyl 2mcg/ml + bupivicaine 0.1% 20ml pre-filled syringe CD Fentanyl 5mcg/ml + bupivicaine 0.1% 250ml bag CD Methadone CD Morphine sulfate CD Morphine sulfate sustained release ‘MXL’ CD Oxycodone (immediate release) and (sustained release) CD Oxycodone Injection CD Pethidine CD Tramadol CD Tapentadol CD Injection, pre-filled syringe, immediate release tablets, oral solution, sachets and suppositories Once daily administration and ‘MST’® twice daily administration Acute Pain and Palliative Care Clinicians only Oxycodone liquid 5mg/5ml must be prescribed by brand ‘Oxynorm’® Palliative Care Clinicians only in patients unresponsive or intolerant of morphine/diamorphine Use in accordance with Trust pain guidance only For initiation by the chronic pain team only nd rd 2 or 3 line For use in severe chronic pain in patients with or without a neuropathic pain element who have tried and failed treatment with morphine or an equivalent opioid. 4.7.3 Neuropathic pain ESTH Treatment of Neuropathic Pain Flow Diagram Unlicensed indication Amitriptyline Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Use in accordance with NICE Duloxetine guidance for the pharmacological management of neuropathic pain Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 38 - NHS Surrey shared care NICE clinical guideline 173 NICE clinical guideline 173 Gabapentin capsules, liquid Nortriptyline Pregabalin Tramadol CD Lidocaine 5% plasters ‘Versatis’® (Nov 2013) Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Unlicensed indication Pain team only Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Pain team only, for post herpetic neuralgia and localised neuropathic pain when all other treatments are ineffective or not tolerated in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013). First month supply from the Trust then review by Pain Team for efficacy, if further treatment required GP to be notified NICE clinical guideline 173 NICE clinical guideline 173 ‘Lyrica’® brand must be prescribed for Neuropathic pain NICE clinical guideline 173 NICE clinical guideline 173 Trigeminal neuralgia Carbamazepine 4.7.4 Antimigraine drugs 4.7.4.1 Treatment of acute migraine Analgesics ‘Migraleve Yellow’ (paracetamol 500mg, codeine phosphate 8mg) ‘Migraleve Pink’ (buclizine 6.25mg, paracetamol 500mg, codeine phosphate 8mg) 5HT1-receptor agonists st 1 line tablets Sumatriptan Nasal spray and injection 2nd line Rizatriptan, rizatriptan melt 2nd line Zolmitriptan Use in accordance with NICE guidance for the management of headaches in young people and adults (Sept 2012) 2nd line Frovatriptan Use in accordance with NICE guidance for the management of headaches in young people and adults (Sept 2012) 4.7.4.2 Prophylaxis of migraine Clonidine Extemporaneous product Clonidine suspension Unlicensed medicine Hospital only Pizotifen Use in accordance with NICE Propranolol guidance for the management of headaches in young people and Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 39 - NICE clinical guideline 150 NICE clinical guideline 150 NICE clinical guideline 150 BNF less suitable for prescribing NICE clinical guideline 150 adults (Sept 2012) Use in accordance with NICE guidance for the management of headaches in young people and adults (Sept 2012) Use in accordance with NICE Gabapentin capsules, liquid guidance for the management of headaches in young people and adults (Sept 2012) rd 3 line after propranolol/topiramate Use in accordance with NICE Botulinum toxin type A guidance for the prevention of headaches in adults with chronic migraine (Jun 2012) PbR exclusion, Hospital only 4.7.4.3 Cluster headache and the trigeminal autonomic cephalalgias st 1 line Sumatriptan Tablets Nasal spray and injection (unlicensed indication) Use in accordance with NICE guidance for the management of headaches in young people and adults (Sept 2012) nd 2 line Zolmitriptan Use in accordance with NICE guidance for the management of headaches in young people and adults (Sept 2012) Unlicensed indication Use in accordance with NICE Verapamil guidance for the management of headaches in young people and adults (Sept 2012) Unlicensed indication Topiramate 4.8 NICE clinical guideline 150 NICE clinical guideline 150 NICE technology appraisal 260 MHRA Drug safety update Botulinum toxin products: rare but serious risk (Oct 2007) NICE clinical guideline 150 NICE clinical guideline 150 NICE clinical guideline 150 ANTIEPILEPTIC DRUGS 4.8.1 Control of the epilepsies Use in accordance with NICE guidance for the management of epilepsies in adults and children NICE clinical guideline 137 MHRA Drug safety update Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug (November 2013) MHRA Drug safety update Antiepileptics: adverse effects on bone (Apr 2009) MHRA Drug safety update Antiepileptics: risk of suicidal thoughts and behaviour (Aug 2008) Carbamazepine and related antiepileptics MHRA Drug safety update Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions associated with the HLA-A* 3101 allele (Dec 2012) Prescribe by brand name Carbamazepine ‘Tegretol’®, ‘Mylan brand’ MHRA Drug safety update Carbamazepine: genetic testing recommended in some Asian populations (Apr 2008) Shared care guidance available for NHS Surrey shared care Eslicarbazepine acetate specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Paediatricians and neurologists only Oxcarbazepine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 40 - Ethosuximide Ethosuximide Gabapentin and pregabalin Gabapentin capsules, liquid Pregabalin Lacosamide Lacosamide Lamotrigine Lamotrigine Levetiracetam Levetiracetam Phenobarbital and primidone Phenobarbital (phenobarbitone) CD ‘Almus’ Phenobarbital (phenobarbitone) oral solution CD Phenytoin Phenytoin ‘Epanutin’®, ‘Flynn’, ‘Milpharm’ Paediatricians and Neurologists only Neurologists only, 3rd line therapy Neurologists only Paediatricians and Neurologists only Neurologists only Prescribe by brand name Unlicensed medicine Hospital only Use capsules for initiation of oral treatment tablets only for established therapy Prescribe by brand name MHRA Drug safety update Phenytoin: risk of StevensJohnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin (Jan 2010) Retigabine Retigabine Rufinamide Rufinamide Stiripentol Stiripentol Topiramate Topiramate Neurologists only, in line with NICE guidance as adjunctive treatment for epilepsy (Jul 2011) NICE technology appraisal 232 MHRA Drug safety update Retigabine: Indication restricted to last line use, and new monitoring requirements after reports of pigment changes in ocular tissue, skin, lips or nails (Jul 2013) Paediatricians and neurologists Hospital only Paediatriciains and Neurologists only for Dravet syndrome in accordance with NICE guidance NICE Clinical guideline 137 Paediatricians and Neurologists only nd rd 2 or 3 line therapy Valproate Sodium valproate MHRA Drug safety update Sodium valproate: special reminder on risk of neurodevelopmental delay in children following maternal use – not for use in pregnancy unless there is no effective alternative (November 2013) MHRA Drug safety update Sodium valproate should not be prescribed to female children, Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 41 - female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated due to neurodevelopmental delay and/or congenital malformations (January 2015) MHRA Drug safety update Valproate and risk of abnormal pregnancy outcomes: new communication materials (February 2016) Vigabatrin Vigabatrin Zonisamide Zonisamide Benzodiazepines Clobazam Clobazam suspension Clonazepam Paediatricians and Neurologists only Neurologists only Paediatricians and Neurologists only Paediatricians and Neurologists only Paediatricians and Neurologists only, and for status epilepticus 4.8.2 Drugs used in status epilepticus Rectal tubes and injection emulsion Diazepam Clonazepam Buccal use, unlicensed route of Lorazepam tablets and injection administration Paediatricians only Midazolam buccal liquid Unlicensed medicine ‘Epistatus’® nd 2 line to Buccolam® CD Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Paediatricians only Midazolam buccal liquid Shared care guidance available for ‘Buccolam’® CD specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Midazolam injection CD Paraldehyde enema MHRA drug safety update Vigabatrin for infantile spasms: risk of movement disorders and MRI abnormalities (Nov 2009) Prescribe by brand name Prescribe by brand name NHS Surrey shared care MHRA Drug safety update Buccal midazolam (Buccolam®): new authorised medicine for paediatric use – care needed when transferring from unlicensed formulations (Oct 2011) Buccal use, unlicensed route of administration Unlicensed medicine Hospital only Phenytoin Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 42 - MHRA Drug safety update Phenytoin: risk of StevensJohnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin (Jan 2010) 4.9 DRUGS USED IN PARKINSONISM AND RELATED DISORDERS 4.9.1 Dopaminergic drugs used in Parkinson’s disease Use in accordance with NICE guidance for the treatment of Parkinson’s disease (Jun 2006) NICE clinical guideline 35 Dopamine-receptor agonists Hospital only MHRA Drug safety update Apomorphine Apomorphine with domperidone: minimising risk of cardiac side effects (April 2016) Bromocriptine Pergolide Consultant Neurologists and Care of Pramipexole the Elderly Clinicians only Consultant Neurologists and Care of Ropinirole the Elderly Clinicians only Consultant Neurologists and Care of Ropinirole Modified release the Elderly Clinicians only for Parkinson’s Disease patients whom are already stabilised on ropinirole immediate release tablets, but have compliance issues or severe fluctuations in movement For patients unable to swallow or Rotigotine patches take oral medications by another route Levodopa Co-beneldopa ‘Madopar’ Co-careldopa ‘Sinemet’ Neurologists and Care of the Elderly ‘Sastravi’ (levodopa, carbidopa, Clinicians only entacapone) Monoamine-oxidase-B inhibitors Consultant Neurologists and Care of Rasagiline the Elderly Clinicians only nd 2 line to selegiline for adjunctive therapy only. GP’s to continue once patients stabilised on therapy Drugs and Driving Law March Selegiline 2015 Catechol-O-methyltransferase inhibitors Consultant Neurologists and Care of Entacapone the Elderly Clinicians only Consultant Neurologists and Care of Tolcapone the Elderly Clinicians only Amantadine Amantadine 4.9.2 Antimuscarinic drugs used in parkinsonism Orphenadrine Procyclidine Trihexyphenidyl (benzhexol) 4.9.3 Drugs used in essential tremor, chorea, tics and related disorders Intractable hiccup Chlorpromazine Haloperidol Primidone ‘Mysoline’® Extemporaneous product Primidone suspension Unlicensed medicine Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 43 - Riluzole Consultant Neurologists only Use in accordance with NICE guidance for motor neurone disease (Jan 2001) PbR exclusion Shared care guidance available for specific CCGs Tetrabenazine Torsion dystonias and other involuntary movements Consultant Gastroenterologists only, Botulinum toxin type A for Achalasia – unlicensed indication PbR exclusion Hospital only Plastic Surgeons, Orthopaedic Botulinum toxin type A Surgeons, Neurologists and Stroke Physicians only PbR exclusion Hospital only NICE technology appraisal 20 NHS Sutton & Merton shared care NHS Surrey shared care MHRA Drug safety update Botulinum toxin products: rare but serious risk (Oct 2007) MHRA Drug safety update Botulinum toxin products: rare but serious risk (Oct 2007) 4.10 DRUGS USED IN SUBSTANCE DEPENDENCE 4.10.1 Alcohol dependence Acamprosate Chlordiazepoxide capsules (see section 4.1.2) Clomethiazole (chlormethiazole) Diazepam (see section 4.1.2) Disulfiram Disulfiram Nalmefene Nalmefene 4.10.2 Nicotine dependence Nicotine replacement therapy ‘Nicorette’ ® Patches 5mg, 10mg & 15mg/16 hours, microtab 2mg, inhalator 10mg & 15mg cartridge, gum 2mg & 4mg Varenicline Varenicline Drug and Alcohol Teams only Drug and Alcohol Teams only Drug and Alcohol Teams only Drug and Alcohol Teams only NICE technology appraisal 325 Use in accordance with the Trust protocol Use in accordance with NICE guidance for smoking cessation (Jul 2007) 4.10.3 Opioid dependence Opioid substitution therapy Buprenorphine CD Sublingual tablets only Use in accordance with NICE guidance, for the management of opioid dependence (Jan 2007) Use in accordance with NICE Methadone CD guidance, for the management of opioid dependence (Jan 2007) Adjunctive therapy and symptomatic treatment Drug and Alcohol Teams only Lofexidine Opioid-receptor antagonists Drug and Alcohol Teams only Naltrexone Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 44 - NICE technology appraisal 123 MHRA Drug safety update Varenicline: adverse psychiatric reactions, including depression (Nov 2008) NICE technology appraisal 114 NICE technology appraisal 114 NICE technology appraisal 115 Use in accordance with NICE guidance, for the management of opioid dependence (Jan 2007) 4.11 DRUGS FOR DEMENTIA 4.11 Drugs for dementia Use in accordance with NICE guidance Alzheimer’s disease (Mar 2011) NICE technology appraisal 217 Dementia (Nov 2006) NICE clinical guideline 42 Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further detail CCG patient pathways to be followed South West London- initiation by Donepezil Consultant Psychogeriatricians, Neurologists and Care of the Elderly clinicians Surrey- initiation by Consultant Psychogeriatricians only South West London- initiation by MHRA Drug safety update Galantamine Consultant Psychogeriatricians, Galantamine associated with Neurologists and Care of the Elderly serious skin reactions (Jan 2016) clinicians Surrey- initiation by Consultant Psychogeriatricians only South West London- initiation by Memantine Consultant Psychogeriatricians, Neurologists and Care of the Elderly clinicians Surrey- initiation by Consultant Psychogeriatricians only Second line. For oscillopsia in people NICE clinical guideline 186 Memantine with Multiple Sclerosis South West London- initiation by MHRA Drug safety update Rivastigmine Consultant Psychogeriatricians, Rivastigmine transdermal patch: Neurologists and Care of the Elderly risk of medication errors (Jun clinicians 2010) Surrey- initiation by Consultant Psychogeriatricians only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 45 - BNF SECTION 5 5.1 5.2 5.3 5.4 5.5 INFECTIONS Antibacterial drugs Antifungal drugs Antiviral drugs Antiprotozoal drugs Anthelmintics MRSA ERADICATION – SEE INFECTION CONTROL GUIDELINES See MRSA skin suppression Chlorhexidine 2% Wash Cloths protocol Chlorhexidine 2% Shower Caps See MRSA skin suppression protocol MHRA Drug safety update Chlorhexidine: reminder of potential for hypersensitivity (Jan 2012) MHRA Drug safety update Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants (Nov 2014) MHRA Drug safety update Chlorhexidine: reminder of potential for hypersensitivity (Jan 2012) MHRA Drug safety update Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants (Nov 2014) Mupirocin 2% nasal ointment ‘Bactroban Nasal’® Prontoderm® foam Prontoderm® nasal gel Chlorhexidine 92mg impregnated sponge dressing ‘Biopatch’® Chlorhexidine 4% surgical scrub See MRSA skin suppression protocol See MRSA skin suppression protocol. Prontoderm® to be used for patients allergic to chlorhexidine See MRSA skin suppression protocol. Prontoderm® to be used for patients allergic to chlorhexidine See central venous access device guidelines See MRSA surgical pre-assessment protocol MHRA Drug safety update Chlorhexidine: reminder of potential for hypersensitivity (Jan 2012) MHRA Drug safety update Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants (Nov 2014) MHRA Drug safety update Chlorhexidine: reminder of potential for hypersensitivity (Jan 2012) MHRA Drug safety update Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants (Nov 2014) MRSA eradication for neonates Octenidine 0.3% wash lotion ‘Octenisan®’ Mupirocin 2% nasal ointment Under the guidance of Consultant Microbiologists in line with Trust Guidelines for the Eradication of Surface Colonisation with MRSA in Neonates Under the guidance of Consultant Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 46 - ‘Bactroban Nasal’® 5.1 Microbiologists in line with Trust Guidelines for the Eradication of Surface Colonisation with MRSA in Neonates ANTIBACTERIAL DRUGS See Trust Antimicrobial Guide which includes Trust initiative to reduce Clostridium Difficile infection (IV antibacterials are Hospital only, unless being used in accordance with the policy for the administration of IV antimicrobials in the community for adult patients) Patient Safety Alert Patient safety alert – addressing antimicrobial resistance through implementation of an antimicrobial stewardship programme (Aug 2015) 5.1.1 Penicillins 5.1.1.1 Benzylpenicillin and phenoxymethylpenicillin Benzylpenicillin (penicillin G) Phenoxymethylpenicillin (penicillin V) 5.1.1.2 Penicillinase-resistant penicillins Flucloxacillin 5.1.1.3 Broad-spectrum penicillins Amoxicillin (amoxycillin) Contact Microbiology if injection Co-amoxiclav NOT being used for orthopaedic trauma 5.1.1.4 Antipseudomonal penicillins Piperacillin with tazobactam ‘Tazocin’® 5.1.2 Cephalosporins, carbapenems and other beta-lactams 5.1.2.1 Cephalosporins Cefalexin Contact Microbiology if NOT being Cefixime used for cystic fibrosis patients or by GU Consultants 2nd line for uncomplicated gonorrhoea Cefotaxime Contact Microbiology if NOT being Ceftazidime used by Haematologists In line with Trust antimicrobial Ceftriaxone guidance Cefuroxime (IV only) 5.1.2.2 Carbapenems MHRA Drug safety update Carbapenems: concomitant use with valproic acid not recommended (May 2010) Microbiology advice only secondary Ertapenem care only Hospital only Microbiology advice only Imipenem with cilastatin Meropenem 5.1.2.3 Other beta-lactam antibiotics Contact Microbiology if NOT being Aztreonam used for cystic fibrosis patients PbR exclusion, Hospital only (when nebulised or inhaled) 5.1.3 Tetracyclines Doxycycline Doxycycline injection Lymecycline Unlicensed medicine Hospital only Contact Microbiology if NOT being Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 47 - Minocycline, minocycline MR Oxytetracycline Tetracycline Tigecycline Tigecycline 5.1.4 Aminoglycosides Amikacin Gentamicin Gentamicin bead chains Gentamicin bone cement Gentamicin bone cement ‘Smart Set GHV’® Tobramycin bone cement ‘Simplex low viscosity’ Gentamicin sulfate in collagen ‘Collatamp’® Tobramycin injection Tobramycin dry powder (for inhalation) ‘Tobi Podhaler’® Tobramycin nebuliser solution used for acne, 2nd line Contact Microbiology if NOT being used for resistant acne and rosacea 1st line for acne NICE clinical guideline 184 Microbiology advice only MHRA Drug safety update Tigecycline (Tygacil®): increased mortality in clinical trials – use only when other antibiotics are unsuitable (Apr 2011) Microbiology advice only Therapeutic Drug Monitoring required Orthopaedic Surgeons only Orthopaedic Surgeons only Orthopaedic Surgeons only in EOC, for use with the ASR hip resurfacing prosthesis and in complex knee replacement surgery Orthopaedic Surgeons for Birmingham hip resurfacing only Consultant Orthopaedic Surgeons only, as additional prophylaxis against infection in reverse shoulder replacement surgery Contact Microbiology if NOT being used for cystic fibrosis patients Use in accordance with NICE guidance for treating pseudomonas lung infection in cystic fibrosis (Mar 2013) PbR excluded. Hospital only PbR excluded Hospital only NICE technology appraisal 276 5.1.5 Macrolides Azithromycin Clarithromycin Erythromycin 5.1.6 Clindamycin Clindamycin 5.1.7 Some other antibacterials Chloramphenicol Chloramphenicol Contact Microbiology if NOT being used for penicillin allergic patients with moderate/severe cellulitis Contact Microbiology if NOT being used in accordance with the meningitis guidelines Hospital only Fusidic Acid Sodium fusidate Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 48 - MHRA Drug safety update Systemic fusidic acid and interaction with statins: risk of rhabdomyolysis (Sept 2011) Vancomycin and Teicoplanin Vancomycin Vancomycin injection to be used orally for treatment of clostridium difficile Therapeutic Drug Monitoring required Teicoplanin Daptomycin Daptomycin Linezolid Linezolid Polymyxins Colistin injection ‘Colomycin’® Colistimethate sodium dry powder (for inhalation) ‘Colobreathe’® Colistimethate sodium ‘Promixin’® Rifaximin Rifaximin Fidaxomicin Fidaxomicin Microbiology advice only Microbiology advice only Hospital only Contact Microbiology if NOT being for Cystic Fibrosis PbR exclusion, Hospital only Use in accordance with NICE guidance for treating pseudomonas lung infection in cystic fibrosis (Mar 2013) PbR exclusion. Hospital only NICE technology appraisal 276 MHRA Drug safety update Colobreathe (colistimethate sodium dry powder for inhalation): risk of capsule breakage—new instructions for use (Nov 2014) Contact Microbiology if NOT being used for Cystic Fibrosis, in accordance with documented patient criteria and GP agreement PbR exclusion, Hospital only Consultant Gastroenterologists only Use in accordance with NICE guidance for preventing episodes of overt hepatic encephalopathy and Trust prescribing guidelines Hospital only for Sutton and Merton CCGs Shared care guidance available for specific CCGs Microbiology advice only Hospital only 5.1.8 Sulphonamides and trimethoprim Contact Microbiology if NOT being Co-trimoxazole used for pneumocystis carinii pneumonia, toxoplasmosis and nocardiasis, and see CSM recommendations for other indications For treatment of toxoplasmosis, Sulfadiazine unlicensed indication, Hospital only Trimethoprim Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 49 - NICE technology appraisal 337 Rifaximin Prescribing Guidelines NHS Surrey Shared Care Two gastroenterologists must approve treatment beyond an initial 6 month period for hepatic encephalopathy in accordance with Trust protocol 5.1.9 Antituberculous drugs To be initiated by the Respiratory Consultants only. Contact Microbiology if NOT being used for TB. NICE clinical guidelines- Tuberculosis – NG33 (Jan 2016) Hospital only Ethambutol Hospital only Isoniazid Hospital only Pyrazinamide Hospital only Rifabutin Hospital only Rifampicin For other indications on microbiology advice only Combined Preparations Hospital only Rifampicin 150mg/isoniazid 100mg Hospital only Rifampicin 300mg/isoniazid 150mg Hospital only ‘Rifater’ (rifampicin 120mg, isoniazid 50mg and pyrazinamide 300mg) 5.1.10 Antileprotic drugs Hospital only Dapsone 5.1.11 Metronidazole and tinidazole Metronidazole 5.1.12 Quinolones Ciprofloxacin Levofloxacin Moxifloxacin Gastroenterologists only nd 2 line for H pylori eradication in penicillin allergic patients Prescribing on the recommendation of Consultant Microbiologists and ophthalmologists only 500mg tablets are non-formulary. Use 400mg tablets NICE clinical guideline 184 MHRA Drug safety update Moxifloxacin: use in pelvic inflammatory disease only when other antibacterials are inappropriate or ineffective (Jan 2011) MHRA Drug safety update Moxifloxacin: restricted use (Aug 2008) Ofloxacin – tablets only 5.1.13 Urinary tract infections Fosfomycin Contact Microbiology if NOT being used for pelvic inflammatory nd disease, 2 line to Doxycycline, in accordance with Trust protocol Microbiology advice only Nitrofurantoin MHRA Drug safety update Nitrofurantoin: reminder on precautions for use, especially renal impairment in (elderly) patients (Aug 2013) MHRA Drug safety update Nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m2 (Sept 2014) Trimethoprim (see section 5.1.8) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 50 - 5.2 ANTIFUNGAL DRUGS See Trust Antifungal Guidelines 5.2.1 Triazole antifungals Fluconazole Itraconazole Posaconazole Voriconazole See Trust antifungal guidelines See Trust antifungal guidelines See Trust antifungal guidelines PbR exclusion Hospital only See Trust antifungal guidelines PbR exclusion Hospital only MHRA Drug safety update Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell carcinoma – test liver function before and during treatment and tell patients to avoid sunlight exposure (May 2014) 5.2.2 Imidazole antifungals Miconazole oral gel 5.2.3 Polyene antifungals Liposomal amphotericin ‘AmBisome’ 5.2.4 Echinocandin antifungals Caspofungin 5.2.5 Other antifungals Flucytosine Griseofulvin suspension Nystatin suspension Terbinafine 5.3 See Trust antifungal guidelines PbR exclusion Hospital only MHRA Drug safety update Parenteral amphotericin B: fatal overdose risk due to confusion between lipid-based and nonlipid-based formulations (Apr 2010) See Trust antifungal guidelines PbR exclusion Hospital only Microbiology advice only Unlicensed medicine Hospital only See Trust antifungal guidelines Contact Microbiology if NOT being used by Dermatologists ANTIVIRAL DRUGS 5.3.1 HIV infection All medications in this category are PbR excluded, hospital only Medicines to be used in accordance with London HIV consortium and NHS England guidance where available MHRA Drug safety update- Antiretroviral medicines: updated advice on body-fat changes and lactic acidosis (Dec 2015) Nucleoside reverse transcriptase inhibitors MHRA Drug safety update Abacavir Abacavir: risk of myocardial infarction – update from epidemiological studies (Jul 2009) Abacavir with lamivudine ‘Kivexa’® Abacavir with lamivudine and zidovudine ‘Trizivir’® Abcavir with lamivudine and dolutegravir ‘Triumeq’® Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 51 - Didanosine Emtricitabine Emtricitabine/tenofovir alafenamde with elvitegravir/cobicistat ‘Genvoya®’ Lamivudine Stavudine Tenofovir disoproxil Tenofovir with emtricitabine ‘Truvada®’ Tenofovir with efavirenz and emtricitabine ‘Atripla’® Tenofovir with emtricitabine and rilpivirine ‘Eviplera’® Tenofovir with cobicistat, elvitegravir and emtricitabine ‘Stribild’® Zidovudine Zidovudine with lamivudine ‘Combivir’ Protease inhibitors Atazanavir Atazanavir with cobicistat ‘Evotaz®’ Darunavir Darunavir with cobicistat ‘Rezolsta®’ Use in line with the Clinical Commissioning Policy Statement by NHS England MHRA Drug safety update Stavudine: use only when there are no appropriate alternatives, and for the shortest possible time (Apr 2011) Use in line with the Clinical Commissioning Policy Statement by NHS England Use in line with the Clinical Commissioning Policy Statement by NHS England Use in line with the Clinical Commissioning Policy Statement by NHS England Indinavir Lopinavir with ritonavir ‘Kaletra’® (tablets and oral solution only) Ritonavir Saquinavir Tipranavir Non-nucleoside reverse transcriptase inhibitors Efavirenz Etravirine Nevirapine Other antiretrovirals Dolutegravir Enfuvirtide Maraviroc Raltegravir Pharmacokinetic enhancers of antiretrovirals Use in line with the Clinical Cobicistat ‘Tybost’® Commissioning Policy Statement by NHS England 5.3.2 Herpes virus infections 5.3.2.1 Herpes simplex and varicella – zoster infection Aciclovir (acyclovir) Contact Microbiology if NOT being Valaciclovir Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 52 - MHRA Drug safety update Saquinavir: update on potential risk of arrhythmia – reduced dose for initial treatment (Dec 2010) used by Medical GU 5.3.2.2 Cytomegalovirus Infection (PbR exclusion) Hospital only Foscarnet Hospital only Ganciclovir Nephrologists only, in accordance Valganciclovir with renal transplant protocols Hospital only 5.3.3 Viral Hepatitis 5.3.3.1 Chronic hepatitis B Peginterferon alfa 2a Lamivudine Adefovir dipivoxil Entecavir Tenofovir 5.3.3.2 Chronic hepatitis C Peginterferon alfa 2b Ribavirin capsules ‘Rebetol’® and ‘Copegus’® Boceprevir Gastroenterologists only Use in accordance with NICE guidance for the treatment of hepatitis B (chronic) (Feb 2006) PbR exclusion Hospital only See section 5.3.1 Gastroenterologists only Use in accordance with NICE guidance for the treatment of hepatitis B (chronic) (Feb 2006) PbR exclusion Hospital only Gastroenterologists only Use in accordance with NICE guidance for the treatment of hepatitis B (chronic) (Feb 2006) PbR exclusion Hospital only Gastroenterologists only Use in accordance with NICE guidance for the treatment of chronic hepatitis B (Aug 2008) PbR exclusion Hospital only Gastroenterologists only Use in accordance with NICE for the treatment of chronic hepatitis B (Jul 2009) PbR exclusion Hospital only NICE technology appraisal 96 Use in accordance with NICE guidance in combination with ribavirin capsules for hepatitis C in adults (Jan 2004, updated Aug 2006, Sept 2010) and children and young people (Nov 2013) PbR exclusion Hospital only Use in accordance with NICE guidance in combination with pegylated interferon alfa for Hepatitis C in adults (Jan 2004, updated Aug 2006, Sept 2010) and children and young people (Nov 2013) PbR exclusion Hospital only Use in accordance with NICE guidance in combination with NICE technology appraisal 75 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 53 - NICE clinical guideline 165 NICE technology appraisal 96 NICE clinical guideline 165 NICE technology appraisal 153 NICE technology appraisal 173 NICE technology appraisal 106 NICE technology appraisal 200 NICE technology appraisal 300 NICE technology appraisal 75 NICE technology appraisal 106 NICE technology appraisal 200 NICE technology appraisal 300 NICE technology appraisal 253 pegylated interferon alfa and ribavarin for hepatitis C (genotype 1, Apr 2012) PbR exclusion Hospital only Daclatasvir Dasabuvir Ledipasvir with sofosbuvir ‘Harvoni’® Ombitasvir with paritaprevir and ritonavir ‘Viekirax’® Simeprevir Use in accordance with NHSE Clinical Commissioning Policy Statement: Treatment of chronic Hepatitis C in patients with cirrhosis (June 2015) and NICE guidance for treating chronic hepatitis C (Nov 2015) PbR exclusion Hospital only Use in accordance with NHSE Clinical Commissioning Policy Statement: Treatment of chronic Hepatitis C in patients with cirrhosis (June 2015) and NICE guidance for treating chronic hepatitis C (Nov 2015) PbR exclusion Hospital only Use in accordance with NHSE Clinical Commissioning Policy Statement:Treatment of chronic Hepatitis C in patients with cirrhosis (June 2015) and NICE guidance for treating chronic hepatitis C (Nov 2015) PbR exclusion Hospital only Use in accordance with NHSE Clinical Commissioning Policy Statement: Treatment of chronic Hepatitis C in patients with cirrhosis (June 2015) and NICE guidance for treating chronic hepatitis C (Nov 2015) PbR exclusion Hospital only Use in accordance with NICE guidance in combination with pegylated interferon alfa and ribavarin for hepatitis C (genotype 1 and 4,Feb 2015) PbR exclusion Hospital only Use in accordance with NICE guidance in combination with ribavarin and/or pegylated interferon alfa for hepatitis C (Feb 2015) PbR exclusion Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 54 Sofosbuvir MHRA Drug safety update Boceprevir (Victrelis) and telaprevir (Incivo): baseline predictive factors for sepsis, worsening liver function, and mortality (Nov 2014) Approval required from specialist centre MDT NICE technology appraisal 364 MHRA Drug safety alert Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone (May 2015) Approval required from specialist centre MDT NICE technology appraisal 365 Approval required from specialist centre MDT NICE technology appraisal 363 MHRA Drug safety alert Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone (May 2015) Approval required from specialist centre MDT NICE technology appraisal 365 NICE technology appraisal 331 Approval required from specialist centre MDT MHRA Drug safety update Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone (Aug 2015) NICE technology appraisal 330 Approval required from specialist centre MDT MHRA Drug safety alert Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone (May 2015) Telaprevir Other Erythropoetin alfa ‘Eprex’® 5.3.4 Influenza Amantadine Oseltamivir Zanamivir 5.3.5 Respiratory syncytial virus Palivizumab 5.4 Use in accordance with NICE guidance in combination with pegylated interferon alfa and ribavarin for hepatitis C (genotype 1, Apr 2012) PbR exclusion Hospital only MHRA Drug safety update Boceprevir (Victrelis) and telaprevir (Incivo): baseline predictive factors for sepsis, worsening liver function, and mortality (Nov 2014) Consultant Gastroenterologists only, for drug induced anaemia. Unlicensed indication, hospital only Use in accordance with Trust guidelines and NICE guidance for influenza prophylaxis (Sep 2008) and for the treatment of influenza (Feb 2009) On recommendation of consultant microbiologist only Use in accordance with NICE guidance for influenza prophylaxis (Sep 2008) and for the treatment of influenza (Feb 2009) Consultant Paediatricians and Neonatologists only, for the prophylaxis of respiratory syncytial virus in high risk infants Use in accordance with the Joint Commissioning for Vaccination and Immunisation guidance PbR exclusion Hospital only ANTIPROTOZOAL DRUGS 5.4.1 Antimalarials Artesunate Artesunate injection ‘Artesun’® MHRA Drug safety update Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone (Aug 2015) NICE technology appraisal 252 Seek expert advice from Microbiology and/or Hospital for Tropical Diseases before prescribing Unlicensed medicine Named patient supply only Hospital only Artemether with Lumefantrine Seek expert advice from Artemether with lumefantrine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 55 - NICE technology appraisal 158 NICE technology appraisal 168 NICE technology appraisal 158 NICE technology appraisal 168 ‘Riamet’® Microbiology and/or Hospital for Tropical Diseases before prescribing Hospital only Chloroquine Chloroquine Mefloquine Mefloquine Primaquine Primaquine Proguanil Proguanil Proguanil with atovaquone ‘Malarone’®, ‘Malarone Paediatric’® Pyrimethamine Pyrimethamine with sulfadoxine ‘Fansidar’ Quinine Quinine sulfate Quinine dihydrochloride injection MHRA Drug safety update Mefloquine: strengthened warnings on neuropsychiatric side effects (Nov 2013) Unlicensed medicine Named patient supply only Hospital only Treatment only Unlicensed medicine Named patient supply only Hospital only Unlicensed medicine Hospital only Dilute and use as an infusion Tetracyclines Doxycycline 5.4.2 Amoebicides Metronidazole 500mg tablets are non-formulary. Use 400mg tablets Diloxanide furoate 5.4.3 Trichomonacides Metronidazole 5.4.4 Antigiardial drugs Mepacrine hydrochloride 500mg tablets are non-formulary. Use 400mg tablets Unlicensed medicine and indication Hospital only Contact Microbiology if NOT being used by Immunologists and Dermatologists 500mg tablets are non-formulary. Use 400mg tablets Metronidazole 5.4.5 Leishmaniacides (Seek expert advice from Microbiology and/or Hospital for Tropical Diseases before prescribing) PbR exclusion Liposomal amphotericin Hospital only ‘Ambisome’® Sodium stibogluconate 5.4.7 Drugs for toxoplasmosis Pyrimethamine Spiramycin Unlicensed medicine Named patient supply only Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 56 - 5.4.8 Drugs for pneumocystis pneumonia Co-trimoxazole Pentamidine isetionate nebuliser Hospital only solution 5.5 ANTHELMINTICS Seek expert advice from Microbiology and/or Hospital for Tropical Diseases before prescribing drugs within this category (with the exception of 5.5.1/2/4). Please refer to the British National Formulary for a list of treatment options. NB: Many of these medicines are unlicensed and are available on a named patient supply only 5.5.1 Drugs for threadworms Mebendazole 5.5.2 Ascaricides Levamisole Unlicensed medicine Named patient supply only Hospital only 5.5.4 Drugs for hookworms Mebendazole Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 57 - BNF SECTION 6 ENDOCRINE SYSTEM 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.1 Drugs used in diabetes Thyroid and antithyroid drugs Corticosteroids Sex hormones Hypothalamic and pituitary hormones and anti-oestrogens Drugs affecting bone metabolism Other endocrine drugs DRUGS USED IN DIABETES See NICE guidance for type 2 diabetes in adults: management (July 2016) NICE clinical guideline 28 See NICE guidance for type 1 diabetes in adults: diagnosis and management (July 2016) NICE clinical guideline 17 6.1.1 Insulins 6.1.1.1 Short –acting insulins Drug Injections Hypurin Porcine Neutral® Hypurin Bovine Neutral® Human Actrapid® Insulin Type Preparations Available Soluble 10 ml vial Soluble 10 ml vial Soluble 10 ml vial Humulin S® Soluble 10 ml vial / 3ml cartridge Novorapid® Insulin aspart 3 ml cartridge / FlexPens Apidra® Insulin glulisine Formulary Restrictions/Comment Initiation by diabetes specialist only Initiation by diabetes specialist only Initiation by diabetes specialist only Initiation by diabetes specialist only 10ml vial /3ml cartridge ClikSTAR 3ml cartridge SoloStar pre-filled pen Humalog® Insulin lispro 10 ml vial / 3ml cartridge Initiation by diabetes specialist KwikPen pre-filled pens only See NICE guidance for insulin pump therapy (Jul 2008) NICE technology appraisal 151 (PbR exclusion, Hospital only) 6.1.1.2 Intermediate and long-acting insulins Use in accordance with NICE guidance diabetes (types 1 and 2) long acting insulins (Dec 2002) NICE technology appraisal 53 MHRA Drug safety update: High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error (April 2015) Drug Insulin Type Insulin glargineLantus® Long-acting insulin analogue Insulin glargine – ‘Abasagler®’ Long-acting insulin analogue Preparations Available 10 ml vial / 3 ml cartridge ClikSTAR 3ml cartridge SoloSTAR pre-filled pens 100unit/ml- 3ml cartridge/prefilled pen Formulary Restrictions/Comment Initiation by diabetes specialist only Initiation by consultant endocrinologists only Biosimilar insulin glargine not bioequivalent to Lantus® MHRA Drug Safety Alert High strength, fixed combination Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 58 - Insulin glargine – ‘Toujeo®’ Insulin degludec Long-acting insulin analogue Long-acting insulin analogue 300unit/ml- 1.5ml pre-filled pen 100unit/ml- 3ml cartridge/ FlexTouch pre-filled pen 200unit/ml- FlexTouch pre-filled pen and biosimilar insulin products: minimising the risk of medication error Initiation by consultant endocrinologists only MHRA Drug Safety Alert High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error Initiation by consultant endocrinologists only: Patients requiring assistance from health carers who are unable to attend at a fixed time each day to administer insulin glargine/detemir rd 3 line after NPH insulin and glargine/detemir for patients with frequent A&E attendances/hospital admissions for hyperglycaemia and DKA Patients on doses greater than 80units who would otherwise need to administer two injections. Hospital only- Trust to maintain supplies Insulin DetemirLevemir® Human Insulatard ge® Humulin I® Long-acting insulin analogue Isophane Insulin Hypurin® porcine isophane Hypurin bovine Isophane® Isophane Insulin (porcine) Isophane Insulin (bovine) Isophane Insulin 3 ml cartridge / FlexPens InnoLet pre-filled pens 10ml vial / 3ml cartridge / InnoLet pre-filled pens. 10 ml vial / 3ml cartridge KwikPen pre-filled pens 10 ml vial 10 ml vial MHRA Drug safety update available in additional higher strengths than existing insulins – care needed to minimise risk of error, including training for patients (April 2013) Initiation by diabetes specialist only Initiation by diabetes specialist only Initiation by diabetes specialist only Initiation by diabetes specialist only Initiation by diabetes specialist only Biphasic insulins Drug Novomix 30® Humalog Mix 25/50® Humulin M3® (30/70) Insulin Type Bisphasic insulin aspart (soluble aspart 30% and aspart protamine 70%) Biphasic insulin lispro Biphasic isophane insulin Preparations Available Formulary Restrictions/Comment 3ml cartridges / FlexPens Initiation by diabetes specialist only 10ml vial / 3ml cartridges KwikPen pre-filled pens. 10 ml vial / 3ml cartridge KwikPen pre-filled pens Initiation by diabetes specialist only Initiation by diabetes specialist only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 59 - Hypurin® Porcine 30/70 Biphasic isophane insulin 10 ml vial Initiation by diabetes specialist only 6.1.1.3 Hypodermic equipment Injection devices are available from Diabetic Clinics ‘Autopen’® ‘HumaPen Luxura’ ‘Novopen 4’® 6.1.2 Oral antidiabetic drugs NICE clinical guideline- Type 2 diabetes in adults: management – NG28 (Dec 2015) 6.1.2.1 Sulphonylureas Glibenclamide Immediate release tablets only Gliclazide Tolbutamide 6.1.2.2 Biguanides Use metformin with caution in renal impairment – increased risk of lactic acidosis; avoid in significant renal impairment. NICE recommends that the dose should be reviewed if eGFR less than 45ml/min and to avoid if less than 30ml/min. Withdraw or interrupt treatment in those of risk of tissue hypoxia or sudden deterioration of renal function, such as those with dehydration, severe infection, shock, sepsis, acute heart failure, respiratory failure or hepatic impairment, or those who have recently had a myocardial infarction. Unlicensed indication for gestational Metformin sachets discontinued. Metformin diabetes Metformin 500mg/5ml oral solution remains available nd 2 line. Diabetologists only in line NICE clinical guideline 87 Metformin modified release tablets with NICE guidance for patients unable to tolerate metformin immediate release tablets due to GI tolerability 6.1.2.3 Other antidiabetic drugs MHRA Drug safety update Dipeptidylpeptidase-4 inhibitors (‘gliptins’): risk of acute pancreatitis (Sept 2012) Diabetologists only NICE clinical guideline 87 Acarbose Use in accordance with NICE guidance for the management of type 2 diabetes (May 2009)) Diabetologists only NICE technology appraisal 315 Canagliflozin Use in accordance with NICE guidance for combination therapy for treating type 2 diabetes (June 2014) Use in accordance with NICE guidance Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016) NICE technology appraisal 390 MHRA Drug safety update SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015) MHRA Drug safety update SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis (April 2016) MHRA Drug safety update Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients (June 2016) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 60 - Dapagliflozin Diabetologists only Use in accordance with NICE guidance for the management of type 2 diabetes (June 2013) NICE technology appraisal 288 Use in accordance with NICE guidance Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016) NICE technology appraisal 390 MHRA Drug safety update SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015) Empagliflozin Diabetologists only Use in accordance with NICE guidance for combination therapy for treating type 2 diabetes (March 2015) Use in accordance with NICE guidance Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016) Exenatide Exenatide modified release Diabetologists only Use in accordance with NICE guidance for the management of type 2 diabetes (May 2009)) Diabetologists only, in accordance with NICE guidance for the treatment of type 2 diabetes (Feb 2012)) Diabetologists only, for the treatment of type 2 diabetes. Hospital only Diabetologists only Linagliptin Follow NICE guidance for type 2 diabetes Diabetologists only Liraglutide Use in accordance with NICE guidance for the treatment of type 2 diabetes (Oct 2010) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 61 - MHRA Drug safety update SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis (April 2016) NICE technology appraisal 336 NICE technology appraisal 390 MHRA Drug safety update SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis (June 2015) MHRA Drug safety update SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis (April 2016) NICE clinical guideline 87 MHRA Drug safety update Exenatide: risk of severe pancreatitis and renal failure (Mar 2009) NICE technology appraisal 248 MHRA Drug safety update Exenatide: risk of severe pancreatitis and renal failure (Mar 2009) Insulin degludec with liraglutide ‘Xultophy’® NICE clinical guideline 87 NICE technology appraisal 203 Lixisenatide Nateglinide Pioglitazone Repaglinide Saxagliptin Sitagliptin Diabetologists only, in accordance with NICE guidance for the treatment of type 2 diabetes (May 2009) Diabetologists only Diabetologists only Use in accordance with NICE guidance for the management of type 2 diabetes (May 2009) Use in accordance with NICE guidance for Non-alcoholic fatty liver disease (NAFLD): assessment and management (July 2016) Unlicensed indication Hospital only Diabetologists only Diabetologists only Follow NICE guidance for type 2 diabetes Diabetologists only Use in accordance with NICE guidance for the management of type 2 diabetes (May 2009) NICE clinical guideline 87 NICE clinical guideline 87 NICE clinical guideline 49 MHRA safety update Insulin combined with pioglitazone: risk of cardiac failure (Jan 2011) MHRA Drug safety update Pioglitazone: risk of bladder cancer (Aug 2011) NICE clinical guideline 87 NICE clinical guideline 87 6.1.4 Treatment of hypoglycaemia Glucagon Glucose oral gel ‘Glucogel’®, ‘Dextrogel’® Chronic hypoglycaemia Diazoxide 6.1.5 Treatment of diabetic nephropathy and neuropathy Diabetic neuropathy Consultant Pain clinic only Duloxetine st 1 line Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Unlicensed indication Amitriptyline Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Pain team only Pregabalin Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Use in accordance with NICE Tramadol CD guidance for the pharmacological management of neuropathic pain (Nov 2013) For short term use only Pain team only, for post herpetic Lidocaine 5% plasters ‘Versatis’® neuralgia and localised neuropathic pain when all other treatments are ineffective or not tolerated in accordance with NICE guidance for Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 62 - NICE clinical guideline 173 NICE clinical guideline 173 NICE clinical guideline 173 ‘Lyrica’® brand must be prescribed for Neuropathic pain NICE clinical guideline 173 NICE clinical guideline 173 Capsaicin 0.075% cream (see section 10.3.2) Gustatory sweating Propantheline the pharmacological management of neuropathic pain (Nov 2013) First month supply from the Trust then review by Pain Team for efficacy, if further treatment required GP to be notified Use in accordance with NICE guidance for the pharmacological management of neuropathic pain (Nov 2013) Gustatory sweating 6.1.6 Diagnostic and monitoring agents for diabetes mellitus Blood monitoring Glucose in blood For gestational diabetes only ‘GlucoMen GM’® Ketones in blood Urinalysis ‘Combur 3’® - Glucose, protein & pH ‘Combur 7’® - Glucose, protein, pH, ketones, blood, leukocytes & nitrites ‘Combur 10 UX’® - Glucose, protein, pH, ketones, blood, leukocytes & nitrites, urobilinogen, bilirubin & specific gravity ‘Diastix’® - Glucose only Ketostix’® - Ketones only Microalbuminuria can be detected ‘Micral – TestII’ ® - Albumin with ‘Micral-TestII’®, but this should be followed by confirmation in the laboratory, since false positive results are common Oral glucose tolerance test ‘Polycal’ Other tests Litmus paper red and blue pH Indicator strips - Range 1-12 ITU only, for use in the Lidco Lithium chloride injection 0.15mmol machine only 6.2 THYROID AND ANTI-THYROID DRUGS 6.2.1 Thyroid hormones Levothyroxine (thyroxine) Liothyronine 6.2.2 Antithyroid drugs Aqueous iodine oral solution (Lugol’s solution) Carbimazole Propylthiouracil 6.3 CORTICOSTEROIDS 6.3.1 Replacement therapy Fludrocortisone Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 63 - NICE clinical guideline 173 6.3.2 Glucocorticoid Therapy Betamethasone injection Betamethasone soluble tablets Dexamethasone Hydrocortisone Hydrocortisone suspension Maternity patients only Haematology patients only Dexamethasone Injection should be prescribed by base strength 4mg phosphate = 3.3.mg base 8mg phosphate = 6.6mg base Extemporaneous product Unlicensed medicine Hospital only Hydrocortisone sodium succinate injection Hydrocortisone sodium phosphate injection Methylprednisolone acetate ‘DepoMedrone’ Methylprednisolone sodium succinate ‘Solu-Medrone’ Methylprednisolone ‘Medrone’® For Multiple Sclerosis patients in accordance with NICE and Haematology patients in accordance with agreed cancer protocols NICE clinical guideline 186 Prednisolone Triamcinolone injection 6.4 SEX HORMONES 6.4.1 Female sex hormones and their modulators 6.4.1.1 Oestrogens and HRT NICE guidance for menopause: diagnosis and management- NG23 (Nov 2015) Conjugated oestrogens with progestogen ‘Premique’ ‘Prempak-C’ Estradiol with progestogen ‘Elleste-Duet’ ‘Elleste Duet Conti’ ‘Evorel Conti’ Patches ‘Femoston’ 1/10 ‘Femoston’ 2/10 ‘Kliovance’ Conjugated oestrogens only ‘Premarin’ Estradiol only ‘Elleste-Solo’ ‘Evorel’ Patches ‘FemSeven’ Patches Tibolone Consultant prescription only MHRA Drug safety update Tibolone ‘Livial’ Tibolone: increased risk of breast cancer recurrence (Feb 2009) Ethinylestradiol Ethinylestradiol (ethinyloestradiol) Unlicensed medicine Ethinylestradiol (ethinyloestradiol) Hospital only 2mcg tablets Raloxifene rd 3 line NICE technology appraisal 161 Raloxifene Use in accordance with NICE Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 64 - guidance for secondary prevention or treatment of post-menopausal osteoporosis only (Jan 2011), when bisphosphonates not tolerated or contra-indicated 6.4.1.2 Progestogens and progesterone receptor modulators Medroxyprogesterone Norethisterone Progesterone (injection, pessaries) Progesterone receptor modulators For the pre-operative treatment of Ulipristal acetate ‘Esmya®’ moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Maximum duration 3 months to be supplied from the Trust. 6.4.2 Male Sex hormones and antagonists Testosterone and esters Endocrinologists and Diabetologists Testosterone gel ‘Testogel’ only nd 2 line to Testogel. Testosterone gel ‘Testim’ Endocrinologists and Diabetologists only nd 2 line Testosterone gel ‘Tostran’ ® Endocrinologists and Diabetologists only Gynaecologists only for use in accordance with NICE guidance for Menopause (Nov 2015) Testosterone injection ‘Sustanon 250’ Anti-androgens Cyproterone NICE clinical guideline 44 NICE clinical guidelines NG23 NHS Surrey shared care MHRA Drug safety update High-dose cyproterone acetate: potential risk of (multiple) meningiomas (Oct 2009) Dutasteride and finasteride Finasteride 6.5 Urologists only MHRA Drug safety update Finasteride: potential risk of male breast cancer (Dec 2009) HYPOTHALAMIC AND PITUITARY HORMONES AND ANTI-OESTROGENS 6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens IVF Statement All Merton, Sutton and Wandsworth IVF services are conducted via the assisted conception unit at St Helier, headed by Miss Sherrif. All Surrey IVF services are conducted via Kingston Hospital, headed by Miss Kakumani. Pharmacy are not to dispense IVF medications unless listed below. All other medications are ordered directly via the units. Use in accordance with NICE guidance for fertility NICE clinical guideline 156 Anti-oestrogens WOMEN- For use by Assisted Clomifene citrate conception unit. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 65 - MEN- For hypogonadotrophic hypogonadism, Urologists only. Unlicensed indication, Hospital only Letrozole Letrozole Anterior pituitary hormones Corticotrophins Tetracosactide (tetracosactrin) Gonadotrophins Chorionic gonadotrophin Menotrophin Urofollitropin ‘Fostmon®’ Growth hormone Somatropin For use by Consultant Obstetricians and Gynaecologists only for ovulation induction in subfertile women who have not responded to clomifene or tamoxifen nd 2 line Unlicensed indication Hospital only ’Choragon’® for undescended testes, Paediatric Endocrinologists only. ‘Pregnyl’® for assisted conception, Obstetricians /Gynaecologists only ‘Pregnyl’® for hypogonadotrophic hypogonadism, Urologists only Hospital only ‘Menopur’® for hypogonadotrophic hypogonadism, Urologists only. Hospital only Assisted conception unit only. For patients with hormone receptor positive breast cancer for embryo production for cryopreservation prior to chemotherapy. Hospital only Use in accordance with NICE guidance for growth hormone deficiency in adults ( Aug 2003) and children (May 2010) PbR exclusion Hospital only NICE technology appraisal 64 NICE technology appraisal 188 NHS Surrey shared care NHS SWL shared care Arginine Hypothalamic hormones Gonadorelin Protirelin Unlicensed medicine Hospital only Unlicensed medicine, unless manufactured by Cambridge Hospital only 6.5.2 Posterior pituitary hormones and antagonists Posterior pituitary hormones Argipressin (synthetic vasopressin) Desmopressin 100mcg/200mcg tablets, 4 mcg/ml injection, 100mcg/ml intranasal solution and 10mcg nasal spray ‘Desmospray’® Desmopressin 120mcg/240mcg ‘Desmomelt’® Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 66 - Patient Safety Alert Risk of severe harm or death when desmopressin is omitted or delayed in patients with cranial diabetes insipidus (Feb 2016) Desmopressin 15mcg/ml injection ‘Octim’® Terlipressin Antidiuretic hormone antagonists Demeclocycline Tolvaptan Tolvaptan 6.6 Haematologists only, prescribing and administration to remain in hospital in accordance with Trust protocol Hospital only Unlicensed medicine Consultant Renal Physicians only in accordance with NICE guidance for treating autosomal dominant polycystic kidney disease (Oct 2015) PbR exclusion, Hospital only NICE technology appraisal 358 DRUGS AFFECTING BONE METABOLISM 6.6.1 Calcitonin and parathyroid hormone Calcitonin (salmon)/salcatonin Hospital only rd 3 line Teriparatide Consultant Rheumatologists only for metabolic bone disease clinic, for secondary prevention or treatment of post-menopausal osteoporosis only, in line with NICE guidance (Jan 2011), when bisphosphonates not tolerated or contra-indicated PbR exclusion, Hospital only NICE technology appraisal 161 6.6.2 Bisphosphonates and other drugs affecting bone metabolism See ESTH Guidance on starting and duration of bisphosphonate treatment for osteoporosis (Feb 2014) MHRA Drug safety update Bisphosphonates: atypical femoral fractures (Jun 2011) MHRA Drug safety update Oral bisphosphonates: oesophageal cancer risk – insufficient evidence of a link (Nov 2010) MHRA Drug safety update Bisphosphonates: osteonecrosis of the jaw (Nov 2009) MHRA Drug safety update Bisphosphonates: atrial fibrillation (Jul 2008) MHRA Drug safety update Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal (Dec 2015) 1st line for primary and secondary NICE technology appraisal 160 Alendronic acid 70 mg prevention or treatment of postmenopausal osteoporosis in line NICE technology appraisal 161 with NICE guidance (Jan 2011) nd 2 line for primary and secondary NICE technology appraisal 160 Risedronate 35 mg prevention or treatment of postmenopausal osteoporosis in line NICE technology appraisal 161 with NICE guidance, if alendronate not tolerated or contraindicated (Jan 2011) nd 2 line for primary and secondary NICE technology appraisal 160 Etidronate disodium prevention or treatment of postmenopausal osteoporosis in line NICE technology appraisal 161 with NICE guidance, if alendronate not tolerated or contraindicated (Jan 2011) Hospital only Pamidronate disodium Palliative Care Clinicians Ibandronic acid 50 mg tablets nd 2 line therapy when weekly Ibandronic acid 150 mg tablets bisphosphonates not suitable ‘Bonviva’® Risedronate 30 mg Sodium clodronate 400 mg and 520 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 67 - mg Zoledronic Acid 800mcg/ml (4mg/5ml) Zoledronic Acid 50mcg/ml (5mg/100ml) Haematology only Hospital only Consultant Rheumatologists and Care of the Elderly only 3rd line use in postmenopausal women in whom alternative therapies are unsuitable Hospital only MHRA Drug safety update Intravenous zoledronic acid: adverse effects on renal function (Apr 2010) MHRA Drug safety update Intravenous zoledronic acid: adverse effects on renal function (Apr 2010) Denosumab MHRA Drug safety update Denosumab: fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment – monitoring recommended (Oct 2012) MHRA Drug safety update Denosumab 60 mg: rare cases of atypical femoral fracture with long-term use (Feb 2013) MHRA Drug safety update Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations (Sept 2014) MHRA Drug safety update Denosumab: intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk (July 2015) Consultant Rheumatologists and NICE technology appraisal 204 Denosumab Care of the Elderly only rd 3 line for primary and secondary NHS Surrey shared care prevention of post menopausal osteoporosis in line with NICE NICE technology appraisal 265 guidance in postmenopausal women in whom alternative therapies are NICE clinical guideline 175 unsuitable (Oct 2010) For the prevention of skeletal related events in adults with bone metastases from solid tumours (Oct 2012) Consultant urologists only For men who are having androgen therapy and have osteoporosis is bisphosphonates are contraindicated or not tolerated (Jan 2014)Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Strontium ranelate MHRA Drug safety update Strontium ranelate (Protelos): should not be used in patients with current or previous venous thromboembolism (VTE) or temporary or permanent immobilisation because of risk of VTE. Rare serious skin reactions may occur within the first weeks of treatment (May 2012) MHRA Drug safety update Strontium ranelate (Protelos): risk of serious cardiac disorders—restricted indications, new contraindications, and warnings (Apr 2013) MHRA Drug safety update Strontium ranelate (Protelos): cardiovascular risk – restricted indication and new monitoring requirements (Mar 2014) rd 3 Line NICE technology appraisal 160 Strontium Ranelate Initiation by Consultant Rheumatologists only NICE technology appraisal 161 Hospital only for Surrey patients Use in accordance with NICE guidance for primary prevention of osteoporotic fragility fractures in postmenopausal women (Jan 2011) and secondary prevention (Jan 2011) when bisphosphonates not tolerated or contra-indicated. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 68 - 6.7 OTHER ENDOCRINE DRUGS 6.7.1 Bromocriptine and other dopaminergic drugs MHRA Drug safety update Ergot-derived dopamine agonists: risk of fibrotic reactions in chronic endocrine uses (Oct 2008) Bromocriptine Cabergoline 6.7.2 Drugs affecting gonadotrophins Assisted conception unit only. Cetrorelix For patients with hormone receptor positive breast cancer for embryo production for cryopreservation prior to chemotherapy. Hospital only Danazol Gonadorelin analogues 1st line Goserelin nd 2 line Urologists only Leuprorelin Urologists for prostate cancer. Triptorelin Paediatric Endocrinologists, for the treatment of central precocious puberty. Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Breast pain (mastalgia) Danazol Unlicensed indication, hospital only Tamoxifen 6.7.3 Metyrapone Metyrapone Polycystic ovarian syndrome Flutamide Metformin Paediatric Endocrinologists only Unlicensed indication Hospital only Paediatric Endocrinologists only Unlicensed indication Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 69 - MHRA Drug safety update Tamoxifen for breast cancer: drug interactions involving CYP2D6, genetic variants, and variability in clinical response (Nov 2010) Use with caution in renal impairment – increased risk of lactic acidosis; avoid in significant renal impairment. See section 6.1.2.2 for more details BNF SECTION 7 OBSTETRICS, GYNAECOLOGY AND URINARY TRACT DISORDERS 7.1 7.2 7.3 7.4 7.1 Drugs used in obstetrics Treatment of vaginal and vulval conditions Contraceptives Drugs for genito-urinary disorders DRUGS USED IN OBSTETRICS 7.1.1 Prostaglandins and oxytocics NICE guidance for preterm labour and birth (Nov 2015) Carboprost Injection, pessaries and vaginal Dinoprostone tablets only Ergometrine maleate Ergometrine & oxytocin ‘Syntometrine’ Gemeprost Consultant Obstetricians and Misoprostol Gynaecologists only Mid-trimester medical abortion Unlicensed indication, hospital only Oxytocin 7.1.1.1 Drugs affecting the ductus arteriosus Maintenance of patency Alprostadil Epoprostenol Closure of ductus arteriosus SCBU only Ibuprofen injection Indometacin (indomethacin) 7.1.2 Mifepristone Mifepristone 7.1.3 Myometrial relaxants Atosiban Atosiban Consultant Obstetricians and Gynaecologists only Mid-trimester medical abortion only Unlicensed indication, hospital only Termination of pregnancy guidelines Termination of pregnancy guidelines For use in accordance with Trust guidance Discussion and agreement with a Consultant Obstetrician required prior to treatment initiation Beta2 agonists MHRA Drug safety update Short-acting beta 2 agonists: restricted use for tocolysis in premature labour (Nov 2013) Parenteral only Salbutamol Parenteral only Terbutaline 7.1.4 Hydroxychloroquine Hydroxychloroquine sulfate Consultant Obstetricians only for recurrent miscarriage. Unlicensed indication. Hospital only. Patient consent to be obtained and documented prior to treatment initiation. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 70 - 7.2 TREATMENT OF VAGINAL AND VULVAL CONDITIONS 7.2.1 Preparations for vaginal and vulval changes NICE guidance for menopause: diagnosis and management- NG23 (Nov 2015) Topical HRT for vaginal atrophy Estradiol vaginal tablets ‘Vagifem’ Estriol cream ‘Gynest’ 7.2.2 Vaginal and vulval infections Preparations for vaginal and vulval candidiasis Clotrimazole pessaries & 1% cream Fluconazole GUM patients only Miconazole ovule Preparations for other vaginal infections GUM patients only Clindamycin cream 2% GUM patients only Metronidazole vaginal gel 0.75% 7.3 CONTRACEPTIVES 7.3.1 Combined hormonal contraceptives MHRA Drug safety update Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small – consider risk factors and remain vigilant for signs and symptoms (Feb 2014) Oral (low and standard strength) Oestrogen content Ethinylestradiol 20 micrograms Ethinylestradiol 30 micrograms Progesterone content Desogestrel 150 micrograms Gestodene 75 micrograms Northisterone acetate 1mg Desogestrel 150 micrograms Drospirenone 3mg Gestodene 75 micrograms Levonorgestrel 150 micrograms Ethinylestradiol 35 micrograms Northisterone acetate 1.5 mg Norgestimate 250 micrograms Norgestimate 500 micrograms 7.3.2 Progestogen-only contraceptives 7.3.2.1 Oral progestogen-only contraceptives ‘Zelleta’® Desogestrol 75 micrograms Norethisterone 350 micrograms ‘Micronor’ 7.3.2.2 Parenteral progestogen-only contraceptives Etonogestrel implant ‘ Nexplanon’® Brand ‘Gedarel’® 20/150 ‘Mercilon’® ‘Aidulan 20’® ‘Loestrin’ 20® ‘Munalea’® ‘Marvelon’® ‘Yasmin’® ‘Aidulan 30’® ‘Microgynon 30’® ‘Maexeni’® ‘Loestrin 30’® ‘Cilest’® ‘Brevinor’ ‘Ovysmen’ MHRA Drug safety update Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung (June 2016) Medroxyprogesterone ‘Depo-Provera’ 7.3.2.3 Intra-uterine progestogen-only system MHRA Drug safety update Intrauterine contraception: uterine perforation—updated information on risk factors (June 2015) MHRA Drug safety update ‘Mirena’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 71 - Levonorgestrel-releasing intrauterine systems: prescribe by brand name (Jan 2016) ‘Jaydess’® Family planning clinic only Prescribe by brand name MHRA Drug safety update Levonorgestrel-releasing intrauterine systems: prescribe by brand name (Jan 2016) Prescribe by brand name 7.3.3 Spermicidal contraceptives Nonoxinol 9 2% ‘Gygel’ 7.3.4 Contraceptive Devices Intra-uterine contraceptive devices MHRA Drug safety update Intrauterine contraception: uterine perforation—updated information on risk factors (June 2015) ‘Flexi-T’ 300 ‘Multiload’ Cu375 Family planning clinic only T-Safe® 380A QuickLoad 7.3.5 Emergency contraception Levonorgestrel ‘Upostelle’® Ulipristal acetate tablets ‘EllaOne® 7.4 Emergency contraception from 72 – 120 hours only DRUGS FOR GENITO-URINARY DISORDERS 7.4.1 Drugs for urinary retention Alpha-blockers Alfuzosin, alfuzosin MR Tamsulosin Terazosin Modified release capsules only 7.4.2 Drugs for urinary frequency, enuresis and incontinence See NICE guidance for the treatment of lower urinary tract symptoms (men) (May 2010) NICE clinical guideline 97 See NICE guidance for the treatment of urinary incontinence in women (Sep 2013) NICE clinical guideline 171 See NHS Surrey Overactive Bladder Treatment Pathway Consultant Urologists and UroMHRA Drug safety update Botulinum toxin type A gynaecologists only for idiopathic Botulinum toxin products: rare and neurogenic detrusor overactivity but serious risk (Oct 2007) Unlicensed indication unless for overactivity due to subcervical spinal cord injury or multiple sclerosis PbR exclusion Hospital only nd 2 line for treatment of OAB Fesoterodine Obstetricians/Gynaecologists and Urologists only Consultant Urologists only. Macroplastique® kits (syringe, gel, Pharmacy will not hold supplies; needle) orders will be placed on an individual patient basis. Pharmacy require advance notification of 5 working days st 1 line for treatment naïve patients 3mg tablets are non-formulary. Oxybutynin Use 2.5mg and 5mg tablets Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 72 - Oxybutynin MR Oxybutynin 3.9mg/24hr transdermal patches ‘Kentera®’ Solifenacin Tolterodine Tolterodine MR Trospium Trospium MR Mirabegron MR nd 2 line nd 2 line for patients unable to tolerate oral medication rd 3 line For patients unable to receive mirabegron and botulinum toxin Consultant Urologists and Urogynaecologists only st 1 line Obstetricians/Gynaecologists and Urologists only nd 2 line Obstetricians/Gynaecologists and Urologists only nd 2 line Obstetricians/Gynaecologists and Urologists only nd 2 line Obstetricians/Gynaecologists and Urologists only nd rd 2 /3 line Use in accordance with NICE guidance for the treatment of overactive bladder (Jun 2013) 7.4.3 Drugs used in urological pain Extemporaneous product Acetic acid bladder irrigation 3% Unlicensed medicine Hospital only Diclofenac sodium NICE technology appraisal 290 MHRA Drug safety update Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events (Oct 2015) MHRA Drug safety update Diclofenac: new contraindications and warnings after a Europe-wide review of cardiovascular safety (Jun 2013) MHRA Drug safety update Diclofenac no longer available without prescription due to cardiovascular safety (Jan 2015) Pethidine Potassium citrate with citric acid effervescent tablets Sodium citrate sachet Tamsulosin Use prior to caesarean section Urologists only, for patients with distal ureteric stones <10mm without complications Full supply from Trust Unlicensed indication Hospital only 7.4.4 Bladder instillations and urological surgery Bacillus Calmette Guerin bladder instillation ‘ImmuCyst’® Mitomycin bladder irrigation Urologists and urogynaecologists Sodium Hyaluronate bladder only instillation Thiotepa bladder irrigation Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 73 - Urological Surgery Glycine irrigation solution 1.5% Sodium chloride 0.9% Maintenance of Indwelling Urinary Catheters Catheter Patency Solutions Sodium chloride 0.9% ‘Solution G’ ‘Solution R’ 7.4.5 Drugs for erectile dysfunction (Consultant Diabetologists and Urologists only) Priapism Unlicensed indication, hospital only Phenylephrine Alprostadil Alprostadil Phosphodiesterase type-5 inhibitors 1st line therapy in accordance with Department of Health patient Sildenafil Trust guidelines criteria restrictions removed for Maximum supply 4 tablets per generic sildenafil only patient Tadalafil Vardenafil 2nd line therapy in accordance with Department of Health patient criteria and Trust guidelines. Maximum supply 4 tablets per patient 2nd line therapy in accordance with Department of Health patient criteria and Trust guidelines Maximum supply 4 tablets per patient Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 74 - BNF SECTION 8 MALIGNANT DISEASE AND IMMUNOSUPPRESSION 8.1 8.2 8.3 Cytotoxic drugs Drugs affecting the immune response Sex hormones and hormone antagonists in malignant disease For further advice on cancer drugs that do not appear in the formulary, but may have been approved by the Cancer Drugs Fund (CDF), contact the Principal Pharmacist, Cancer Services Bleep 606 or Medicines Management 701 6075 / 721 4037/721 4038 8.1 CYTOTOXIC DRUGS 8.1 Cytotoxic drugs (Hospital only) Treatment for cytotoxic-induced side-effects Anthracycline side-effects Consultant Haematologists, in Dexrazoxane accordance with Trust protocol PbR exclusion, Hospital only MHRA Drug safety update Dexrazoxane: restriction of use to adults with advanced or metastatic breast cancer only (Jul 2011) Chemotherapy-induced mucositis and myelosuppression Calcium folinate (folinic acid) Urothelial toxicity Mesna 8.1.1 Alkylating drugs (PbR exclusion, Hospital only) Use in accordance with NICE Bendamustine guidance for lymphocytic leukaemia (Feb 2011) Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations Busulfan Use in accordance with NICE Carmustine guidance as recommended option for newly diagnosed high-grade glioma if more than 90% of the tumour has been removed (Jun 2007) Funding approval required, in line with NHS England recommendations Chlorambucil Cyclophosphamide Lomustine Melphalan Thiotepa NICE technology appraisal 216 NICE technology appraisal 121 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy 8.1.2 Anthracyclines and other cytotoxic antibiotics (PbR exclusion, Hospital only) Bleomycin Daunorubicin Doxorubicin Funding approval required, in line NICE technology appraisal 389 Liposomal Doxorubicin with the Cancer Drugs Fund Use in accordance with NICE for Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 75 - The Trust will not initiate treatment Epirubicin Idarubicin Mitomycin Mitoxantrone (mitozantrone) Pixantrone gemcitabine for treating recurrent ovarian cancer (April 2016) but it will be available for use for patients admitted on therapy Use in accordance with NICE guidance for treating multiply relapsed or refractory aggressive non-Hodgkin’s B-cell lymphoma (Feb 2014) NICE technology appraisal 306 8.1.3 Antimetabolites (PbR exclusion, Hospital only) Use in accordance with NICE Azacitidine guidance for myelodysplastic syndromes (Mar 2011) Funding approval required, in line with NHS England recommendations Cladribine Funding approval required, in line Clofarabine with the Cancer Drugs Fund Cytarabine Use in accordance with NICE Capecitabine guidance for treatment of colorectal cancer as recommended among first options for metastatic colorectal cancer (May 2003). NICE technology appraisal 61 Gemcitabine with paclitaxel – a recommended option for metastatic breast cancer only when docetaxel monotherapy or docetaxel plus capecitabine are also appropriate (Jan 2007) NICE technology appraisal 116 Use in accordance with NICE as monotherapy after surgery for stage III (Dukes’ C) colon cancer (Apr 2006) NICE technology appraisal 100 Use in accordance with NICE with platinum-containing drugs as a first line option for advanced, inoperable stomach cancer (July 2010) Funding approval required, in line with NHS England recommendations Fludarabine NICE technology appraisal 218 Use in accordance with NICE guidance for lymphocytic leukaemia (Sept 2001) and lymphocytic leukaemia (Feb 2007) Fluorouracil Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 76 - NICE technology appraisal 191 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy NICE technology appraisal 29 NICE technology appraisal 119 Gemcitabine Nelarabine Mercaptopurine Mercaptopurine 10mg tablets Methotrexate Pemetrexed Use in accordance with NICE guidance as first line option for advanced or metastatic disease if Karnofsky score 50 or more, if curative surgery not an option. Not for second line use (May 2001). NICE technology appraisal 25 Use in accordance with NICE for Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) NICE technology appraisal 389 Funding approval required, in line with NHS England recommendations Funding approval required, in line with the Cancer Drugs Fund Unlicensed medicine, hospital only Use in accordance with Trust protocol Pre-filled syringes for ectopic pregnancy Unlicensed medicine Use in accordance with NICE guidance as recommended option for specified people with advanced or unresectable malignant pleural mesothelioma (Jan 2008) Use in accordance with NICE guidance for treatment of lung cancer as recommended first line option for locally advanced or metastatic adeno-or large-cell carcinoma types of non-small-cell lung cancer (Sep 2009) Use in accordance with NICE guidance as recommended maintenance treatment for some people with non-small-cell lung cancer (June 2010) Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations Tegafur with uracil (and folinic acid) Use in accordance with NICE guidance for treatment of colorectal cancer as recommended among first options for metastatic colorectal cancer (May 2003) Tioguanine (thioguanine) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 77 - The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Ensure correct frequency of dosing NICE technology appraisal 135 NICE technology appraisal 181 NICE technology appraisal 190 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 61 8.1.4 Vinca alkaloids and etoposide (PbR exclusion, Hospital only) Etoposide Vinblastine Vincristine 8.1.5 Other antineoplastic drugs (PbR exclusion, Hospital only) Bevacizumab Funding approval required, in line Bevacizumab with the Cancer Drugs Fund Bortezomib Bortezomib The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE guidance for multiple myeloma (Oct st 2007) 1 line (Jul 2011) NICE technology appraisal 129 Use in accordance with NICE guidance for induction therapy in multiple myeloma before high-dose chemotherapy and autologous stem cell transplantation (Apr 2014) NICE technology appraisal 311 NICE technology appraisal 228 NICE technology appraisal 370 Use in accordance with NICE guidance for previously untreated mantle cell lymphoma (Dec 2015) Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations Brentuximab Brentuximab Ceritinib Ceritinib Cetuximab Cetuximab Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance Ceritinib for previously treated anaplastic lymphoma kinase positive non- small-cell lung cancer (June 2016) NICE technology appraisal 395 Use in accordance with NICE guidance for head and neck cancer as recommended option with radiotherapy for locally advanced squamous cell disease with Karnofsky score 90% or more, and if platinum-based chemotherapy inappropriate (Jun 2008) NICE technology appraisal 145 Use in accordance with NICE guidance for treatment of colorectal cancer-recommended in combination with FOLFOX as first line option for metastatic colorectal cancer in specific circumstances. Use with FOLFIRI, if FOLFOX unsuitable (Aug 2009) NICE technology appraisal 176 Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 78 - Crisantaspase Crisantaspase (asparaginase) Temozolomide Temozolomide Use in accordance with NICE guidance for people with recurrent malignant glioma (brain cancer ) (Apr 2001) NICE technology appraisal 23 Use in accordance with NICE guidance as recommended option for newly diagnosed glioblastoma multiforme in specified circumstances (June 2007) NICE technology appraisal 121 Funding approval required, in line with NHS England recommendations Eribulin Eribulin Hydroxycarbamide Hydroxycarbamide (hydroxyurea) Ipilimumab Ipilimumab Ipilimumab and Nivolumab Ipilimumab and Nivolumab Funding approval required, in line with the Cancer Drugs Fund The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE guidance for treatment of melanoma (stage III or IV) as recommended option after prior therapy for advanced melanoma (unresectable or metastatic), only as part of agreed patient access scheme (Dec 2012) NICE technology appraisal 268 Use in accordance with NICE guidance for treating adults with previously untreated advanced (unresectable or metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme (July 2014) NICE technology appraisal 319 Funding approval required, in line with NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy Use in accordance with NICE guidance for treating advanced melanoma (July 2016) NICE technology appraisal 400 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 79 - The Trust will not initiate treatment but it will be available Olaparib Olaparib Funding approval required, in line with the Cancer Drug fund for use for patients admitted on therapy Use in accordance with NICE guidance for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum-based chemotherapy (Jan 2016) NICE technology appraisal 381 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy Funding approval required, in line with NHS England recommendations Panitumumab Panitumumab Panobinostat Panobinostat Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance for treating multiple myeloma after at least 2 previous treatments (Jan 2016) NICE technology appraisal 380 Funding approval required, in line with NHS England recommendations Pembrolizumab Pembrolizumab Pentostatin Pentostatin Pertuzumab Pertuzumab Use in accordance with NICE guidance for treating advanced melanoma after disease progression with ipilimumab (Octo 2015) and for advanced melanoma not previously treated with ipilimumab (Nov 2015) Funding approval required, in line with the Cancer Drugs Fund NICE technology appraisal 357 NICE technology appraisal 366 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy The Trust will not initiate treatment but it will be available for use for patients admitted on therapy Platinum compounds Cisplatin Oxaliplatin Use in accordance with NICE guidance as recommended options after surgery for stage III (Dukes’ C) colon cancer in combination with 5fluorouracil and folinic acid (Apr 2006) Funding approval required, in line with NHS England recommendations Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 80 - NICE technology appraisal 100 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Protein kinase inhibitors MHRA Drug safety update BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation (May 2016) Use in accordance with NICE NICE technology appraisal 310 Afatinib guidance for adults with locally advanced or metastatic non-smallThe Trust will not initiate cell lung cancer if they have the treatment but it will be available EGFR-TK mutation and have not for use for patients admitted on had a EGFR-TK inhibitor previously therapy. and the drug is provided at the discount agreed in the patient access scheme (April 2014) Axitinib Bosutinib Cabozantinib Crizotininb Dabrafenib Funding approval required, in line with NHS England recommendations Use in accordance with NICE guidance for treating advanced renal cell carcinoma after failure of prior systemic treatment (Feb 2015) Funding approval required, in line with NHS England recommendations Funding approval required, in line with the Cancer Drugs Fund Funding approval required, in line with the Cancer Drugs Fund Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance as option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma only if the manufacturer provides the medicine with the discount agreed in the patient access scheme (Oct 2014) Use in accordance with NICE guidance for Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (June 2016) Dasatinib Erlotinib Funding approval required, in line with NHS England recommendations Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance for the treatment of nonsmall-cell lung cancer if one previous chemotherapy regimen Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 81 - NICE technology appraisal 333 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy The Trust will not initiate treatment but it will be available for use for patients admitted on therapy The Trust will not initiate treatment but it will be available for use for patients admitted on therapy MHRA Drug safety update Crizotinib (Xalkori▼): risk of cardiac failure (Nov 2015) NICE technology appraisal 321 NICE technology appraisal 396 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 162 ineffective, as cost neutral alternative to docetaxel. Not recommended in locally advanced or metastatic NSCLC after one prior unsuccessful regimen when docetaxel unsuitable. Not recommended after two prior unsuccessful regimens, including docetaxel (Nov 2008) Everolimus Gefitinib Ibrutinib Idelalisib Imatinib Use in accordance with NICE guidance for treatment of lung cancer (non-small cell, EGFR-TK mutation positive) as recommended first-line option in locally advanced or metastatic non-small-cell lung cancer (June 2012) NICE technology appraisal 258 Use in accordance with NICE guidance for erlotinib and gefitinib for treating nonsmall-cell lung cancer that has progressed after prior chemotherapy (Dec 2015) NICE technology appraisal 374 Funding approval required, in line with NHS England recommendations Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance as recommended option for first treatment of EGFR-TK mutation positive locally advanced or metastatic non-small-cell lung cancers (July 2010) The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 192 Use in accordance with NICE guidance for erlotinib and gefitinib for treating nonsmall-cell lung cancer that has progressed after prior chemotherapy (Dec 2015) NICE technology appraisal 374 Funding approval required, in line with NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Funding approval required, in line with the Cancer Drugs Fund Funding approval required, in line with the Cancer Drugs Fund. Use in accordance with NICE guidance for treating chronic lymphocytic leukaemia (Oct 2015) Use in accordance with NICE guidance for chronic myeloid leukaemia (Oct 2003, Jan 2012, Apr 2012) NICE technology appraisal 359 NICE technology appraisal 70 NICE technology appraisal 241 NICE technology appraisal 251 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 82 - Nilotinib Nintedanib Use in accordance with NICE guidance as recommended as firstline for management of people with KIT (CD117)-positive unresectable and/or metastatic GISTs (Oct 2004, Nov 2010) NICE technology appraisal 86 Use in accordance with NICE guidance as the adjuvant treatment for up to 3 years for adults who are at high risk of relapse after surgery for KIT (CD117)-positive gastrointestinal stromal tumours, as defined by the Miettinen 2006 criteria (Nov 2014) NICE technology appraisal 326 (review of TA 196) Funding approval required, in line with NHS England recommendations Use in accordance with NICE guidance for chronic myeloid leukaemia (Jan 2012, Apr 2012), Funding approval required, in line with NHS England recommendations Use in accordance with NICE guidance for previously treated locally advanced, metastatic, or locally recurrent non-small-cell lung cancer (July 2015) Use in accordance with NICE guidance for treating idiopathic pulmonary fibrosis (Jan 2016) Pazopanib Ponatinib Regorafenib Funding approval required, in line with NHS England recommendations Use in accordance with NICE guidance for treatment of renal cell carcinoma (first line metastatic) as recommended option for some people with renal cell carcinoma (Feb 2011) Funding approval required, in line with NHS England recommendations Funding approval required, in line with the Cancer Drugs Fund Funding approval required, in line with the Cancer Drugs Fund Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 83 - NICE technology appraisal 209 For the indications different from Haematology the Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 241 NICE technology appraisal 251 NICE technology appraisal 347 The Trust will not initiate treatment for lung cancer, but it will be available for use for patients admitted on therapy. NICE technology appraisal 379 NICE technology appraisal 215 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. MHRA Drug safety update Ponatinib (Iclusig▼): risk of vascular occlusive events (Nov 2014) The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Ruxolitinib Sorafenib Sunitinib Use in accordance with NICE guidance for treatment of disease related splenomegaly or symptoms in adults with myelofibrosis. (Mar 2016) Funding approval required, in line with the Cancer Drugs Fund Funding approval required, in line with the Cancer Drugs Fund Use in accordance with NICE guidance for renal cell carcinoma (Mar 2009) The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 169 MHRA Drug safety update Sunitinib: risk of osteonecrosis of the jaw (Jan 2011) Use in accordance with NICE guidance for treatment of gastrointestinal stromal tumours as recommended option for unresectable or metastatic malignant GIST if imatinib unsuccessful or unsuitable (Sep 2009) NICE technology appraisal 179 Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 396 Temsirolimus Funding approval required, in line with the Cancer Drugs Fund Trametinib Use in accordance with NICE guidance for Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (June 2016) Vandetanib Funding approval required, in line with the Cancer Drugs Fund Vemurafenib Use in accordance with NICE for treatment of melanoma (BRAF V600 mutation positive, unresectable or metastatic) Vemurafenib – recommended for this indication only as part of agreed patient access scheme (Dec 2012) Radium- 223 dichloride Radium-223 dichloride ‘Xofigo’® NICE technology appraisal 386 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 269 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Funding approval required, in line with NHS England recommendations MHRA Drug safety update Vemurafenib (Zelboraf▼): risk of potentiation of radiation toxicity (Nov 2015) Use in accordance with NICE guidance for treating hormonerelapsed prostate cancer with bone metastases (Jan 2016) The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 84 - Funding approval required, in line with NHS England recommendations Taxanes Cabazitaxel Docetaxel Paclitaxel Topoisomerase I inhibitors Topotecan Funding approval required, in line with the Cancer Drugs Fund NICE technology appraisal 391 Use in accordance with NICE guidance Cabazitaxel for hormonerelapsed metastatic prostate cancer treated with docetaxel (May 2016) The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICEfor adjuvant option with doxorubicin and cyclophosphamide for early node-positive breast cancer (Sep 2006) NICE technology appraisal 109 Use in accordance with NICE as hormone-refractory metastatic prostate cancer with Karnofsky score 60% or more. Not recommended if the disease recurs after a first course (Jun 2006). NICE technology appraisal 101 Funding approval required, in line with NHS England recommendations Use in accordance with NICE for ovarian cancer (Jan 2003) Cisplatin or carboplatin, with or without paclitaxel – recommended as alternatives for first-line use (usually following surgery) in ovarian cancer. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 55 Paclitaxel, liposomal doxorubicin, topotecan – recommended options in advanced disease depending largely upon platinum sensitivity, resistance, tolerance, and allergy. (May2005) NICE technology appraisal 91 Use in accordance with NICE for Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) NICE technology appraisal 389 Funding approval required, in line with NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE for treatment of lung cancer (small-cell) Oral topotecan – a recommended option for relapsed small-cell lung cancer in specified circumstances. IV topotecan – not recommended. NICE technology appraisal 184 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 85 - (Nov 2009) Use in accordance with NICE for treatment of cervical cancer (recurrent) as recommended option for recurrent or stage IVB cervical cancer with cisplatin, if cisplatin not given before (Oct 2009) NICE technology appraisal 183 Use in accordance with NICE for Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) NICE technology appraisal 389 Funding approval required, in line with NHS England recommendations Trastuzumab Trastuzumab Trastuzumab Emtansine Trastuzumab Emtansine Trabectedin Trabectedin The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE for metastatic breast cancer with HER2 at 3+: Trastuzumab with paclitaxel – recommended if no prior chemo and anthracyclines inappropriate. Trastuzumab monotherapy – recommended after at least two other regimens tried including at least one anthracycline, taxane, and hormonal treatment if appropriate. NICE technology appraisal 34 Use in accordance with NICE as recommended option for early-stage HER2-positive breast cancer after surgery, chemotherapy, and radiotherapy if applicable (Aug 2006) NICE technology appraisal 107 Use in accordance with NICE guidance as a possible first line treatment for specified types of HER2-positive metastatic gastric adenocarcinoma. (Nov 2011) NICE technology appraisal 208 Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Funding approval required, in line with the Cancer Drugs Fund The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE guidance for soft tissue sarcoma treatment as recommended option for advanced disease where NICE technology appraisal 185 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 86 - treatment with anthracyclines and ifosfamide is unsuitable, has failed, or is not tolerated (Feb 2010) Use in accordance with NICE for Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) Funding approval required, in line with NHS England recommendations Tretinoin Tretinoin Vismodegib Vismodegib 8.2 Funding approval required, in line with the Cancer Drugs Fund NICE technology appraisal 389 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. DRUGS AFFECTING THE IMMUNE RESPONSE 8.2.1 Antiproliferative immunosuppressants Azathioprine Cardiologists and Nephrologists, Mycophenolate use in accordance with NICE guidance for immunosuppressive therapy in renal transplant patients (Sept 200, April 2006) Nephrologists and Neurologists, use as a steroid sparing agent in the management of steroid dependent, frequently relapsing Nephrotic Syndrome and Myasthenia Gravis (unlicensed indication) NICE technology appraisal 85 NICE technology appraisal 99 MHRA Drug safety update Mycophenolate mofetil: pure red cell aplasia (Jul 2009) MHRA Drug safety update Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis (Jan 2015) PbR exclusion, Hospital only Rheumatologists and Dermatologists for scleroderma and systemic lupus erythematosus (unlicensed indications). Hospital only in SWL, shared care arrangements in Surrey Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 87 - MHRA Drug safety update Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men (Dec 2015) NHS Surrey shared care 8.2.2 Corticosteroids and other immunosuppressants Nephrologists only Basiliximab Use in accordance with NICE guidance for immunosuppressive therapy in renal transplant patients (Sept 2004, April 2006) PbR exclusion, Hospital only PbR exclusion, Hospital only (when Ciclosporin (cyclosporin) ® ® used for transplant ‘Deximune ’, ‘Neoral ’, ® immunosuppression only) ‘Sandimmun ’ ‘Deximune’® 1st line for new patients Prednisolone Sirolimus Tacrolimus ‘Adoport’®,‘Prograf’® Tacrolimus modified release ‘Advagraf’®, Nephrologists only Use in accordance with NICE guidance for immunosuppressive therapy in renal transplant patients (Sept 2004, April 2006) PbR exclusion Hospital only Nephrologists only for use in accordance with NICE guidance for immunosuppressive therapy in renal transplant patients (Sept 2004, April 2006) PbR exclusion Hospital only Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Nephrologists only for use in accordance with NICE guidance for immunosuppressive therapy in renal transplant patients (Sept 2004, April 2006) PbR exclusion Hospital only Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details NICE technology appraisal 85 NICE technology appraisal 99 Prescribe by brand name MHRA Drug safety update Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) NICE technology appraisal 85 NICE technology appraisal 99 MHRA Drug Safety Update Prescribe and dispense by brand name (Jun 2012) NICE technology appraisal 85 NICE technology appraisal 99 MHRA Drug Safety Update Prescribe and dispense by brand name (Jun 2012) NICE technology appraisal 85 NICE technology appraisal 99 8.2.3 Anti-lymphocyte monoclonal antibodies (PbR exclusion, Hospital only) Haematologists and neurologists NICE technology appraisal 312 Alemtuzumab only Use in accordance with NICE guidance for relapsing-remitting multiple sclerosis (May 2014) Use in accordance with NICE NICE technology appraisal 65 Rituximab guidance for Non-Hodgkin’s lymphoma (Sept 2003) and follicular NICE technology appraisal 137 non-Hodgkin’s lymphoma (Feb 2008) maintenance (Jun 2011) NICE technology appraisal 226 st Chronic lymphocytic leukaemia (1 line (Jul 2009) NICE technology appraisal 174 Chronic lymphocytic leukaemia relapsed (Jul 2010) NICE technology appraisal 193 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 88 - st 1 line Follicular lymphoma stage III – V (Jan 2012) Funding approval required, in line with NHS England recommendations Obinutuzumab Ofatumumab Use in accordance with NICE guidance for untreated chronic lymphocytic leukaemia in combination with chlorambucil (June 2015) Funding approval required, in line with NHS England recommendations Use in accordance with NICE guidance for untreated chronic lymphocytic leukaemia in combination with chlorambucil or bendamustine (June 2015) Funding approval required, in line with NHS England recommendations NICE technology appraisal 243 MHRA Drug safety update Rituximab: screen for hepatitis B virus before treatment (Dec 2013) MHRA Drug safety update Tumour necrosis factor alpha inhibitors: risk of tuberculosis – screen all patients before starting treatment and monitor them closely (Apr 2014) NICE technology appraisal 343 NICE technology appraisal 344 MHRA Drug safety update Ofatumumab: reminder of risk of serious and fatal infusion reactions—always give premedication and monitor patients carefully (August 2014) 8.2.4 Other immunomodulating drugs Interferon alfa (PbR exclusion, Hospital only) Interferon alfa 2a ‘Roferon-A’ Consultant Gastroenterologists only Pegylated interferon alfa for use in accordance with NICE ‘ViraferonPeg’® & ‘Pegasys’® guidance and licensed indications Interferon Beta (PbR exclusion, Hospital only) MHRA Drug safety update Interferon beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome (October 2014) Consultant Neurologists only NICE clinical guideline 8 Interferon beta 1a ‘Avonex’® and Use in accordance with NICE ‘Rebif’® guidance for the management of multiple sclerosis (Nov 2003) Consultant Neurologists only NICE clinical guideline 8 Interferon beta 1b ‘Betaferon’® Use in accordance with NICE guidance for the management of multiple sclerosis (Nov 2003) Consultant Neurologists only NICE clinical guideline 8 Interferon beta 1b ‘Extavia® Use in accordance with NICE guidance for the management of multiple sclerosis (Nov 2003) Bacillus Calmette-Guérin Bladder Instillation (Hospital only) Bacillus Calmette-Guérin ‘ImmuCyst’® Dimethyl fumarate NICE technology appraisal 320 Dimethyl fumarate Consultant Neurologists only Use in accordance with NICE MHRA Drug safety update guidance for relapsing remitting Dimethyl fumarate (Tecfidera): multiple sclerosis (August 2014) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 89 - fatal PML in an MS patient with severe, prolonged lymphopenia (March 2015) MHRA Drug safety update Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy (April 2016) Fingolimod (PbR exclusion, Hospital only) MHRA Drug safety update Fingolimod: not recommended for patients at known risk of cardiovascular adverse events. New advice for extended early monitoring for those with significant bradycardia or heart block after the first dose (May 2012) MHRA Drug safety update Fingolimod: bradycardia and heart block – repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption (Jan 2013) Consultant Neurologists only NICE technology appraisal 254 Fingolimod ‘Gilenya’® Use in accordance with NICE guidance for relapsing remitting MHRA Drug safety update multiple sclerosis (April 2012) Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections (April 2016) Glatiramer Acetate (PbR exclusion, Hospital only) Consultant Neurologists only NICE clinical guideline 8 Glatiramer acetate ‘Copaxone’® Use in accordance with NICE guidance for the management of multiple sclerosis (Nov 2003) Lenalidomide, Pomalidomide and Thalidomide (PbR exclusion, Hospital only) Consultant Haematologists NICE technology appraisal 171 Lenalidomide Use in accordance with NICE guidance for multiple myeloma (Jun NICE technology appraisal 322 2009) and for treating myelodysplastic syndromes Pregnancy prevention programme associated with an isolated deletion to be followed 5q cytogenetic abnormality (Sept 2014) MHRA Drug safety update Named patient supply only Lenalidomide: risk of serious Prescription authorisation form hepatic adverse drug reactions – required routine monitoring of liver function now recommended (Jan Funding approval required, in line 2013) with the Cancer Drugs Fund/NHS England recommendations MHRA Drug safety update Lenalidomide: risk of second primary malignancy – update (Nov 2011) Lenalidomide: risk of thrombosis and thromboembolism (Feb 2011) Consultant Haematologists MHRA Drug safety update Pomalidomide Funding approval required, in line Pomalidomide (Imnovid▼): risks with NHS England of cardiac failure, interstitial lung recommendations disease and hepatotoxicity (May 2015) Thalidomide Consultant Haematologists Use in accordance with NICE Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 90 - MHRA Drug safety update Pomalidomide (Imnovid▼): risk of hepatitis B reactivation (May 2016) NICE technology appraisal 228 st guidance 1 line for multiple myeloma (Jul 2011) Named patient supply only Prescription authorisation form required Pregnancy prevention programme to be followed MHRA Drug safety update Thalidomide: risk of second primary malignancies (May 2013) MHRA Drug safety update Thalidomide: risk of arterial and venous thromboembolism (Jul 2011) MHRA Drug safety update Thalidomide: reduced starting dose in patients older than age 75 years (Dec 2015) Mifamurtide Mifamurtide Use in accordance with NICE as recommended option as a treatment for specified children, adolescents and young adults with osteosarcoma (Oct 2011) Funding approval required, in line with NHS England recommendations Natalizumab (PbR exclusion, Hospital only) Consultant Neurologists only in Natalizumab accordance with NICE guidance for multiple sclerosis (Aug 2007) NICE technology appraisal 235 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 127 MHRA Drug safety update Natalizumab: risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment (Mar 2011) MHRA Drug safety update Natalizumab: risk of progressive multifocal leukoencephalopathy increases after 2 years of therapy (Mar 2010) MHRA Drug safety update Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection (April 2016) Nivolumab (PbR exclusion, Hospital only) Use in accordance with NICE for Nivolumab treating advanced (unresectable or metastatic) melanoma (Feb 2016) Funding approval required, in line with the Cancer Drug fund Teriflunomide (PbR exclusion, Hospital only) Consultant Neurologists only in Teriflunomide accordance with NICE guidance for relapsing-remitting multiple sclerosis Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 91 - NICE technology appraisal 384 The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. NICE technology appraisal 303 (Jan 2014) 8.3 SEX HORMONES AND HORMONE ANTAGONISTS IN MALIGNANT DISEASE 8.3.1 Oestrogens Diethylstilbestrol (stilboestrol) Ethinylestradiol (ethinyloestradiol) 8.3.2 Progestogens Medroxyprogesterone Megestrol Use in accordance with the Palliative Care Formulary only NICE clinical guideline 175 NICE clinical guideline 175 Norethisterone 8.3.4 Hormone antagonists 8.3.4.1 Breast cancer These medications are to be used in accordance with local protocol and NICE guidance hormonal treatments for early breast cancer NICE technology appraisal 112 (Nov 2006). The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Use in accordance with NICE NICE technology appraisal 112 Anastrozole guidance for early oestrogenreceptor-positive breast cancer postmenopause. Use in accordance with NICE NICE technology appraisal 112 Exemestane guidance- for early oestrogenreceptor-positive breast cancer postmenopause. Use in accordance with NICE NICE technology appraisal 112 Letrozole guidance for early oestrogenreceptor-positive breast cancer postmenopause. Assisted conception unit. For patients with hormone receptor positive breast cancer for embryo production for cryopreservation prior to chemotherapy. Unlicensed indication MHRA Drug safety update Tamoxifen for breast cancer: drug interactions involving CYP2D6, genetic variants, and variability in clinical response (Nov 2010) 8.3.4.2 Gonadorelin analogues and gonadotrophin-releasing hormone antagonists Gonadorelin analogues Monthly preparation only Goserelin 3.6mg Urologists only Leuprorelin 3.75mg nd 2 line Monthly preparation only Anti-androgens Use in accordance with NICE NICE technology appraisal 259 Abiraterone guidance for treatment of prostate cancer (metastatic, castration NICE technology appraisal 387 resistant). Abiraterone (following cytotoxic therapy)– a recommended The Trust will not initiate option for metastatic prostate cancer treatment but it will be available after testosterone reduction therapy for use for patients admitted on and docetaxel (June 2012) therapy. Use in accordance with NICE Tamoxifen Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 92 - guidance for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (July 2016) Bicalutamide Cyproterone acetate Enzalutamide Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations PbR exclusion Hospital only Urologists only Use in accordance with NICE guidance for metastatic hormonerelapsed prostate cancer in adults whose disease has progressed during or after docetaxel-containing chemotherapy, only if the manufacturer provides enzalutamide with the discount agreed in the patient access scheme (July 2014) NHS Surrey shared care NICE clinical guideline 175 MHRA Drug safety update High-dose cyproterone acetate: potential risk of (multiple) meningiomas (Oct 2009) NICE technology appraisal 316 Use in accordance with NICE guidance for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (Jan 2016) NICE technology appraisal 377 Funding approval required, in line with the Cancer Drugs Fund/NHS England recommendations The Trust will not initiate treatment but it will be available for use for patients admitted on therapy. Gonadotrophin-releasing hormone antagonists Use in accordance with NICE Degarelix guidance Degarelix for treating advanced hormone-dependent prostate cancer (Aug 2016) 8.3.4.3 Somatostatin analogues PbR exclusion Octreotide ‘Sandostatin’ Acromegaly, neuroendocrine tumours, prevention of complications following pancreatic surgery (licensed indications). Palliative Care to reduce intestinal secretions and to reduce vomiting due to bowel obstruction (unlicensed indication). Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 93 - NICE technology appraisal 404 BNF SECTION 9 NUTRITION AND BLOOD 9.1 9.2 9.3 9.4 9.5 9.6 9.8 9.1 Anaemias and some other blood disorders Fluids and electrolytes Intravenous nutrition Oral nutrition Minerals Vitamins Metabolic disorders ANAEMIAS AND SOME OTHER BLOOD DISORDERS 9.1.1 Iron deficiency anaemias 9.1.1.1 Oral iron Ferrous fumarate syrup 140mg (45mg iron/5ml) Ferrous gluconate 300mg (35mg iron) Ferrous sulfate 200mg (65mg iron) Sodium feredetate elixir 190mg (27.5mg iron/5ml) ‘Sytron’® Iron and folic acid Ferrous fumarate and folic acid ‘Pregaday’ 9.1.1.2 Parenteral iron (Hospital only) MHRA Drug safety update Intravenous iron and serious hypersensitivity reactions: new strengthened recommendations to manage and minimise risk (Aug 2013) Nephrologists, Haematologists, Ferric carboxymaltose ‘Ferinject’® Gastroenterologists and Obstetricians and Gynaecologists only Outpatient use only Iron (III)-hydroxide dextran complex ‘Cosmofer’ (IV and IM) ® Haematologists, Iron isomaltoside 1000 ‘Monofer ’ Gastroenterologists, Nephrologists and Obstetricians and nd Gynaecologists only 2 line only when doses of 1gram are required in a single infusion Outpatient use only Iron sucrose injection ‘Venofer’ 9.1.2 Drugs used in megaloblastic anaemias Folic acid Hydroxocobalamin 9.1.3 Drugs used in hypoplastic, haemolytic and renal anaemias Erythropoietins Renal patients only in line with PAN Darbepoetin alfa ‘Aranesp’ London tender, PbR exclusion Haematologists only Use in accordance with NICE guidance for cancer treatment induced anaemias (May 2008,Nov 2014) Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 94 - NICE technology appraisal 142 NICE technology appraisal 323 Epoetin alfa ‘Eprex’® Epoetin beta ‘NeoRecormon’ Methoxy polyethylene glycol epoetin beta ‘Mircera’® Epoetin zeta Renal patients only in line with PAN London tender, PbR exclusion Haematologists only Use in accordance with NICE guidance for cancer treatment induced anaemias (May 2008,Nov 2014) Hospital only Renal patients only in line with PAN London tender, PbR exclusion Haematologists only Use in accordance with NICE guidance for cancer treatment induced anaemias (May 2008, Nov 2014) Hospital only Renal patients only in line with PAN London tender, PbR exclusion Hospital only Renal patients only in line with PAN London tender, PbR exclusion Haematologists only Use in accordance with NICE guidance for cancer treatment induced anaemias (Nov 2014) Hospital only NICE technology appraisal 142 NICE technology appraisal 323 Only use ‘Eprex’® if ‘NeoRecormon’® and/or ‘Aranesp’® are unsuitable or not tolerated. NICE technology appraisal 142 NICE technology appraisal 323 MHRA Drug safety update Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded (May 2015) NICE technology appraisal 323 Sickle-cell disease Hydroxycarbamide Iron overload Desferrioxamine mesilate (deferoxamine mesilate) Deferasirox PbR exclusion Hospital only PbR exclusion Order for a consultant-specified patient only Hospital only Paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome Use in accordance with NICE NICE Highly Specialised Eculizumab guidance for atypical haemolytic Technologies (HST1) (Jan 2015) uraemic syndrome, only to be used following agreement from the specialist centre in Newcastle PbR exclusion, Hospital only Renal protection during contrast procedures Unlicensed medicine N-acetylcysteine tablets Hospital only 9.1.4 Drugs used in platelet disorders Idiopathic thrombocytopenic purpura See South West London treatment pathway for adult patients with immune (idiopathic) thrombocytopenic purpura (ITP) Azathioprine (see section 8.2.1) ‘Deximune’® 1st line for new Prescribe by brand name Ciclosporin (cyclosporin) ® patients (see section 8.2.2) ‘Deximune ’, ® ® MHRA Drug safety update ‘Neoral ’, ‘Sandimmun ’ Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) Corticosteroids (see section 6.3) Cyclophosphamide (see section 8.1.1) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 95 - Danazol (see section 6.7.2) Eltrombopag Intravenous immunoglobulins (see section 14.5) Rituximab (see section 8.2.3) Romiplostim Vincristine (see section 8.1.4) Essential thrombocythaemia Anagrelide 9.1.6 Drugs used in neutropenia Filgrastim Lenograstim Pegfilgrastim 9.2 Unlicensed indication, hospital only Use in accordance with NICE guidance for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (Jul 2013) PbR exclusion, Hospital only rd th 3 or 4 line PbR exclusion Hospital only Use in accordance with NICE guidance for thrombocytopenic purpura (Apr 2011) PbR exclusion Hospital only NICE technology appraisal 293 MHRA Drug safety update Rituximab: screen for hepatitis B virus before treatment (Dec 2013) MHRA Drug safety update Tumour necrosis factor alpha inhibitors: risk of tuberculosis – screen all patients before starting treatment and monitor them closely (Apr 2014) NICE technology appraisal 221 Haematologists only Hospital only PbR exclusion Hospital only Clinical trial use only PbR exclusion Hospital only Haematologists only nd 2 line PbR exclusion (funding via Individual Funding Request route only) Hospital only FLUIDS AND ELECTROLYTES 9.2.1 Oral preparations for fluid and electrolyte imbalance 9.2.1.1 Oral potassium Potassium bicarbonate and chloride effervescent (12mmol potassium and 8mmol chloride per tablet) ‘Sando-K’ Potassium chloride MR (8mmol potassium and chloride per tablet) ‘Slow-K’ Potassium chloride syrup (1mmol potassium and chloride per ml) ‘KayCee-L’ Management of hyperkalaemia Polystyrene sulphonate resins Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 96 - MHRA Drug safety update Filgrastim: Risk of potentially lifethreatening capillary leak syndrome (Sep 2013) MHRA Drug safety update Pegfilgrastim: Risk of potentially life-threatening capillary leak syndrome (Sep 2013) NHS England Individual Funding Request (IFR) form ‘Calcium Resonium’, ‘Resonium A’® Calcium resonium enema For adult patients, pre-made kits available 30g/100 ml Extemporaneous product Unlicensed medicine Hospital only For Paediatric patients, enemas prepared on the neonatal unit using methylcellulose 2% Extemporaneous product Unlicensed medicine Hospital only 9.2.1.2 Oral sodium and water Sodium chloride MR tablets (10mmol sodium and chloride per tablet) ‘Slow Sodium’ Oral rehydration therapy (ORT) Oral rehydration salts ‘Dioralyte’ 9.2.1.3 Oral bicarbonate Sodium bicarbonate 500 mg capsules (6mmol sodium and bicarbonate per capsule) 9.2.2 Parenteral preparations for fluid and electrolyte imbalance NICE clinical guidelines- Intravenous fluid therapy in children and young people in hospital – NG29 (Dec 2015) 9.2.2.1 Electrolytes and water Intravenous sodium Sodium chloride 0.45%, 0.9%, 2.7%, 30% Not recommended for use in MHRA Drug safety update Sodium chloride 0.18% & glucose children (NPSA Alert 2007/22) due Hypotonic saline solution: do not 4% to risk of hyponatraemia use in children except in specialist settings under expert supervision (Oct 2012) Sodium chloride 0.45% and glucose 5% Sodium Chloride 0.9% and 5% glucose (500ml bags) Sodium lactate intravenous infusion compound ‘Hartmann’s Solution’ Intravenous glucose MHRA Drug safety update Glucose solutions: false blood glucose readings when used to flush arterial lines, leading to incorrect insulin administration and potentially fatal hypoglycaemia (Jul 2012) Glucose 5%, 10%, 20%, 50% Intravenous potassium Potassium chloride 0.15% (20mmol/L) and 0.3% (40mmol/L) with sodium chloride 0.9% Potassium chloride 0.15% (20mmol/L) with glucose 5% Potassium chloride 0.15% (20mmol/L) and 0.3% (40mmol/L) with sodium chloride 0.18% and glucose 4% Potassium chloride injection concentrate 15% CD Potassium chloride (10mmol/L) and Paediatric patients only (20mmol/L) with sodium chloride Unlicensed medicine Hospital only 0.45% and glucose 5% Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 97 - Potassium chloride (10mmol/L) and sodium chloride 0.9% with glucose 5% (500ml) Potassium chloride (20mmol/L) and sodium chloride 0.9% with glucose 5% (500ml) Potassium chloride 0.3% (40mmol) with sodium chloride 0.9% (100ml) Potassium chloride (10mmol) with glucose 10% (500ml) Bicarbonate and lactate Sodium bicarbonate 1.26% polyfusor, 1.4% polyfusor, 4.2% ampoules, 8.4% polyfusor, minijet, ampoules Trometamol ‘Tham’® 7.2% injection Paediatric patients only Unlicensed medicine Hospital only Intensive care areas only Unlicensed medicine Hospital only To be used in accordance with Trust ‘Guideline for the antenatal management of established diabetes (type 1 & 2)’ Unlicensed medicine Neonatal unit only nd 2 line Unlicensed medicine Hospital only Water Water for injection Obtain via purchasing and logistics Water for irrigation Water for enteral feeds 9.2.2.2 Plasma and plasma substitutes Albumin solutions Albumin (available direct from Haematology) Plasma substitutes Dextran 70 in sodium chloride 0.9% ‘Geloplasma’® Etherified starch Pentastarch 10% in sodium chloride 0.9% ‘Hemohes’® 9.3 INTRAVENOUS NUTRITION (PbR exclusion, Hospital only) Doctors requiring Parenteral Nutrition should please contact Members of the Nutrition Team St Helier Epsom Pharmacy: 721 4024 or bleep 596 Pharmacy: Please refer to St Helier details Dietitian: 721 2272 or bleep 267 Dietitian: 701 6193 or bleep 787 Chemical Pathology Consultant: 701 6102 Duty Biochemist: 701 6101/6901 Out Of Hours – Discussion with the on-call Chemical Pathologist is required before initiation of total parenteral nutrition on all wards except intensive care units. Contact on call Pathologist via switchboard. 9.4 ORAL NUTRITION 9.4 Oral nutrition Feed thickeners ® ‘Nutilis Clear ’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 98 - Patient Safety Alert Risk of death from asphyxiation by accidental ingestion of fluid/food thickening powder (Feb 2015) Paediatric patients only ‘Carobel’, instant ‘Vitaquick’ Sip feeds ‘Fortisip yoghurt style’ (Raspberry, peach & orange, vanilla & lemon) ‘Fortijuce’ (Forest fruits, lemon, orange, tropical, blackcurrant) ‘Fortisip Compact’® (Banana, Strawberry, Vanilla, Mocha) ‘Fortisip Compact Protein’® (Berry, Vanilla, Mocha and PeachMango) ‘Fortisip Multi Fibre’ (Banana, chocolate, orange, strawberry, vanilla) ‘PreOp Nutricia’® st 1 line oral nutritional supplement for adults Enhanced recovery programme for elective colorectal surgery and fractured neck of femur only On recommendation of Dietitian only ‘Elemental 028 extra’ (Grapefruit, orange and pineapple, summerfruits) ‘Modulen IBD’ Renal dietitians only ‘Nepro HP’® (Vanilla, strawberry) ‘Scandishake Mix’ (Chocolate, strawberry, vanilla, unflavoured) Management plan required for GP ‘Vital 1.5kcal’ on discharge Paediatric patients only ‘Fortini Multi Fibre’ (Banana, chocolate, strawberry, vanilla) Enteral feeds Patients who require enteral feeds upon discharge must be given a 14-16 day discharge supply. ‘Nutrison Multi Fibre’ ‘Nutrison Soya’ ‘Nutrison Standard’ On recommendation of Dietitian only ‘Nutrison Concentrated’ ‘Nutrison Energy’ ‘Nutrison Energy Multi Fibre’ ‘Nutrison Low Sodium’ ‘Nutrison 1200 Complete Multi Fibre’® ‘Nutrison 1000 Complete Multi Fibre’® ‘Nutrison Protein Plus’® ‘Peptisorb’ Paediatric patients only ‘Infatrini’ ‘Nutrini’ ‘Nutrini Energy’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 99 - ‘Nutrini Energy Multi Fibre’ ‘Nutrini Low Energy Multi Fibre’ ‘Nutrini Multi Fibre’ ‘Tentrini’ ‘Tentrini Energy’ ‘Tentrini Energy Multi Fibre’ Infant formulae ‘Enfamil AR’ ‘Enfamil O-Lac’ ‘Galactomin 17’ ‘Galactomin 19’ ‘Nutramigen 1 with LGG’ ‘Nutramigen 2 with LGG’ ‘Pregestimil Lipil’® ‘SMA’® Gold Prem 2 ‘SMA’® Gold Breast milk fortifier ‘SMA LF’ On recommendation of Dietitian only ‘MCT Pepdite’ ‘MCT Pepdite’ +1 ‘Neocate Active’ ‘Neocate Advance’ ‘Neocate LCP’ nd 2 Line ‘Nutramigen Puramino’® ‘Pepdite’ ‘Pepdite’ 1+’ Metabolic disorders ‘Energivit’ ‘Wysoy’ On recommendation of Dietitian only ‘Emsogen’® ‘Loprofin’ PKU Drink ‘Loprofin’ Sno-Pro Drink ‘Phlexy-10’ exchange system – capsules and tablets ‘Phlexy-10’ exchange system – drink mix (Blackcurrant and apple) ‘PK Aid 4’ ‘PKU gel’ (Orange, unflavoured) ‘XP Maxamaid’ (Orange, unflavoured) ‘XP Maxamum’ (Orange, unflavoured) Energy supplements ‘Duocal Liquid’ ‘Duocal Super Soluble Powder’ ‘Maxijul Super Soluble Powder’ ‘Polycal Liquid’ (Orange, neutral) ‘Polycal Powder’ On recommendation of Dietitian only st Strawberry flavour 1 line ‘Calogen Emulsion’ (Neutral, strawberry) ‘Duocal MCT Powder’ ‘Liquigen’ ‘Protifar’® Powder Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 100 - ‘MCT Oil’ Vitamins/mineral supplements - Paediatric patients only ‘Paediatric Seravit’ (Unflavoured, pineapple) ‘Phlexy-Vits’ Other ‘Forticreme’ complete (Vanilla, chocolate, forest fruit) On recommendation of Dietitian only ‘Caprilon’ ‘Casilan 90’ Renal/senior dietitians only ‘ProSource Liquid’® (Citrus berry, neutral, orange crème) Renal patients only ‘Resource Optifibre’® 9.5 MINERALS 9.5.1 Calcium and magnesium 9.5.1.1 Calcium supplements Oral preparations Calcium carbonate chewable tablets 600 mg (15 mmol calcium per tablet) ‘Adcal’ Calcium Syrup (2.55 mmol calcium per 5 mls) Renal patients only ‘Calcichew’® 500 mg (12.5 mmol calcium per tablet) ‘Sandocal’ 1000 effervescent tablets 1000=25 mmol calcium per tablet) Parental preparations Calcium chloride injection 10% minijet Calcium gluconate 10% injection 9.5.1.2 Hypercalcaemia & hypercalciuria Nephrologists and Endocrinologists Cinacalcet only Use in accordance with specified patient criteria NICE guidance (Jan 2007) PbR exclusion, Hospital only 9.5.1.3 Magnesium See Treatment of hypomagnaesmia guidelines Magnesium aspartate ‘Magnaspartate’® (10mmol 1 magnesium per sachet) Magnesium sulfate injection 10%, 50% 9.5.2 Phosphorus 9.5.2.1 Phosphate supplements ‘Addiphos’ Phosphate effervescent tablets (phosphate 16.1mmol per tablet) ‘Phosphate- Sandoz’® Phosphate Polyfusor Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 101 - NICE technology appraisal 117 Two endocrinologists must approve treatment for Primary Hyperparathyroidism in accordance with Trust protocol Potassium phosphate 17.42% injection CD Sodium acid phosphate 1mmol/ml Critical Care areas only Unlicensed medicine Hospital only Neonatal unit only Unlicensed medicine Hospital only 9.5.2.2 Phosphate-binding agents NICE clinical guideline 157: Hyperphosphataemia in chronic kidney disease (Mar 2013) Aluminium hydroxide capsules ‘Alu-Cap’ Renal patients only Calcium carbonate 500 mg nd 2 line after calcium acetate (12.5mmol calcium per tablet) ‘Calcichew’ Nephrologists only Calcium acetate (6.2mmol calcium st 1 line in accordance with NICE per tablet) ‘Phosex’ guidelines Nephrologists only Calcium acetate and magnesium nd 2 line after calcium acetate carbonate tablets ‘Osvaren®’ Nephrologists only Lanthanum rd 3 line for patients not achieving target levels on other phosphate binders including sevelamer PbR exclusion, Hospital only Nephrologists only Sevelamer rd 3 line for use when other phosphate binders have failed or are unsuitable PbR exclusion, Hospital only 9.5.3 Fluoride Sodium fluoride mouthwash, tablets, drops 9.5.4 Zinc Zinc sulfate 125mg effervescent tablets (45mg zinc per tablet) ‘Solvazinc’ Zinc sulfate 220mg capsules (50mg zinc per capsule) ‘Zincomed’ 9.6 VITAMINS 9.6.1 Vitamin A Vitamins A and D capsules 9.6.2 Vitamin B group ‘Pabrinex High Potency’ IM and IV Pyridoxine (Vitamin B6) Pyridoxine 10mg tablets Unlicensed medicine Hospital only Thiamine (Vitamin B1) Vitamin B tablets, Compound Strong 9.6.3 Vitamin C Ascorbic acid effervescent tablets Ascorbic acid tablets 9.6.4 Vitamin D See ESTH Guidance on treating vitamin D deficiency in adult patients Alfacalcidol Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 102 - Colecalciferol solution 600units in 0.2ml (3,000 units per ml) Colecalciferol 800 unit tablets ‘Desunin’® Colecalciferol 300,000 unit injection Unlicensed medicine Hospital only Unlicensed medicine Use in accordance with Trust guidelines Calcium and ergocalciferol tablets (calcium 2.4mmol, ergocalciferol 400units per tablet) Calcium with colecalciferol tablets (calcium 12.5mmol, colecalciferol, 200 units per tablet) ‘Calcichew D3’ Calcium with colecalciferol tablets (calcium 15mmol, colecalciferol, 400 units per tablet) ‘Adcal-D3’®, ‘Adcal-D3 Dissolve’® Calcium with colecalciferol tablets (calcium 7.5mmol, colecalciferol, 200 units per tablet) ‘Adcal-D3 Caplets’® Calcitriol 9.6.5 Vitamin E Alpha tocopheryl acetate 9.6.6 Vitamin K Menadiol sodium phosphate Phytomenadione (Vitamin K1) ‘Konakion MM’, ‘Konakion MM Paediatric’ Phytomenadione tablets 9.6.7 Multivitamin Preparations ‘Abidec’ ‘Ketovite’ Multivitamins BP ‘Renavit’® 9.8 Named patient supply only Unlicensed medicine Hospital only Renal patients only Initiation on recommendation of renal dietitians for haemodialysis patients METABOLIC DISORDERS 9.8.1 Drugs used in metabolic disorders Elosulfase alfa Use in accordance with NICE guidance for treating mucopolysaccharidosis type Iva (Dec 2015) PbR exclusion, Hospital only 9.8.2 Acute porphyrias Haem Arginate For acute porphyrias only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 103 - NICE highly specialised technology HST2 Contact the Acute Porphyria service at Kings College Hospital (contact number in BNF) to confirm diagnosis and gain approval to treat with Haem Arginate. Kings College Hospital hold the emergency supplies of Haem Arginate and they must approve treatment. Once approved please contact Pharmacy who will organise obtaining supplies. Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 104 - BNF SECTION 10 MUSCULOSKELETAL AND JOINT DISEASES 10.1 Drugs used in rheumatic diseases and gout 10.2 Drugs used in neuromuscular disorders 10.3 Drugs for the treatment of soft-tissue disorders and topical pain relief 10.1 DRUGS USED IN RHEUMATIC DISEASES AND GOUT 10.1.1 Non-steroidal anti-inflammatory drugs (NSAIDs) Due to the cardiovascular risk and gastrointestinal toxicity, all NSAIDs including Cox-II inhibitors should be prescribed at the lowest effective dose and for the shortest duration. MHRA Drug safety update Non-steroidal anti-inflammatory drugs: reminder on renal failure and impairment (May 2009) MHRA Drug safety update Non-steroidal anti-inflammatory drugs: cardiovascular risk (Oct 2012) st 1 line MHRA Drug safety update Ibuprofen High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk (June 2015) MHRA Drug safety update Diclofenac sodium Diclofenac: new contraindications and warnings after a Europe-wide review of cardiovascular safety (Jun 2013) MHRA Drug safety update Diclofenac no longer available without prescription due to cardiovascular safety (Jan 2015) Diclofenac sodium ‘Dyloject’® Diclofenac with misoprostol ‘Arthrotec 50’ Indometacin (indomethacin) Mefenamic acid Naproxen Phenylbutazone Piroxicam ‘Feldene Melt’ Celecoxib Meloxicam For use in theatres by anaesthetists only for the prevention and treatment of peri and postoperative pain Not for use on wards or A&E st 1 line Ankylosing spondylitis Named patient supply only Unlicensed medicine Hospital only Anaesthetists only 10.1.2 Corticosteroids 10.1.2.1 Systemic corticosteroids Prednisolone 10.1.2.2 Local corticosteroid injections Dexamethasone Hydrocortisone acetate ‘Hydrocortistab’ Methylprednisolone acetate ‘DepoMedrone’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 105 - Dexamethasone Injection should be prescribed by base strength 4mg phosphate = 3.3.mg base 8mg phosphate = 6.6mg base Methylprednisolone acetate with lidocaine ‘Depo-Medrone’® with lidocaine Triamcinolone acetonide 10.1.3 Drugs that suppress the rheumatic disease process Gold Sodium aurothiomalate Penicillamine Penicillamine Antimalarials Chloroquine Shared care guidance available for Hydroxychloroquine sulfate specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Drugs affecting the immune response Azathioprine st ‘Deximune’® 1 line for new patients Ciclosporin (cyclosporin) ® ® ‘Deximune ’, ‘Neoral ’, ® ‘Sandimmun ’ Leflunomide Methotrexate 2.5mg tablets, ‘Metoject’® auto-injector pre-filled pens Rheumatologists only, in accordance with British Rheumatology Society guidelines Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Use in accordance with Trust protocol Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details NHS Surrey shared care Prescribe by brand name MHRA Drug safety update Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) NHS Sutton & Merton shared care Ensure correct frequency of dosing NHS Surrey shared care NHS SWL shared care Cytokine modulators (PbR exclusion, Hospital only) MHRA Drug safety update Tumour necrosis factor alpha inhibitors: risk of tuberculosis – screen all patients before starting treatment and monitor them closely (Apr 2014) NHS SWL Care Pathway – Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis NHS SWL Care Pathway – Psoriatic Arthritis NHS SWL Care Pathway – Rheumatoid Arthritis NHS Surrey Biologic Drug Treatment Pathway Consultant Rheumatologists only NICE technology appraisal 280 Abatacept Use in accordance with local protocol and NICE guidance for NICE technology appraisal 195 rheumatoid arthritis (Apr 2013) and juvenile idiopathic arthritis (Dec NICE technology appraisal 373 2015) For rheumatoid arthritis not NICE technology appraisal 375 previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) Consultant Rheumatologists only NICE technology appraisal 130 Adalimumab Use in accordance with local protocol and NICE guidance NICE technology appraisal 195 Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 106 - For rheumatoid arthritis (Oct 2007) For rheumatoid arthritis after the failure of a TNF inhibitor (Aug 2010) For ankylosing spondylitis (May 2008) For juvenile idiopathic arthritis (Dec 2015) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) For ankylosing spondylitis and nonradiographic axial spondyloarthritis (Feb 2016) Belimumab Certolizumab pegol Etanercept ‘Enbrel’®, Benepali’® Consultant Rheumatologists and Dermatologists. Use in accordance with NICE guidance for psoriatic arthritis (Aug 2010) Use in accordance with NICE guidance for treating active autoantibody-positive systemic lupus erythematosus (June 2016) Consultant Rheumatologists only Use in accordance with local protocol and NICE guidance for rheumatoid arthritis (Feb 2010) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) For ankylosing spondylitis and nonradiographic axial spondyloarthritis (Feb 2016) Consultant Rheumatologists only Use in accordance with local protocol and NICE guidance For rheumatoid arthritis (Oct 2007) For rheumatoid arthritis after the failure of a TNF inhibitor (Aug 2010) For Juvenile idiopathic arthritis, For ankylosing spondylitis (May 2008) For juvenile idiopathic arthritis (Dec 2015) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) For ankylosing spondylitis and nonradiographic axial spondyloarthritis (Feb 2016) Consultant Rheumatologists and Dermatologists. Use in accordance with NICE guidance for psoriatic arthritis (Aug 2010) Consultant Rheumatologists only Golimumab Use in accordance with NICE guidance For rheumatoid arthritis ((Jun 2011) For ankylosing spondylitis (Aug Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 107 - NICE technology appraisal 143 (replaced by 383) NICE technology appraisal 199 NICE technology appraisal 373 NICE technology appraisal 375 NICE technology appraisal 383 NICE technology appraisal 397 NICE technology appraisal 186 NICE technology appraisal 375 NICE technology appraisal 383 NICE technology appraisal 130 NICE technology appraisal 195 NICE technology appraisal 35 NICE technology appraisal 143 (replaced by 383) NICE technology appraisal 199 NICE technology appraisal 373 NICE technology appraisal 375 NICE technology appraisal 383 Prescribe by brand name NICE technology appraisal 220 NICE technology appraisal 225 NICE technology appraisal 233 2011) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) For ankylosing spondylitis and nonradiographic axial spondyloarthritis (Feb 2016) Infliximab ‘Remicade’®, ‘Remsima’® Consultant Rheumatologists and Dermatologists. Use in accordance with NICE guidance for psoriatic arthritis (Apr 2011) Consultant Rheumatologists only Use in accordance with local protocol and NICE guidance For rheumatoid arthritis (Oct 2007) For rheumatoid arthritis after the failure of a TNF inhibitor (Aug 2010) For ankylosing spondylitis (May 2008) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) For ankylosing spondylitis and nonradiographic axial spondyloarthritis (Feb 2016) (replaced by 383) NICE technology appraisal 375 NICE technology appraisal 383 NICE technology appraisal 130 NICE technology appraisal 195 NICE technology appraisal 143 (replaced by 383) NICE technology appraisal 199 NICE technology appraisal 375 NICE technology appraisal 383 Prescribe by brand name Consultant Rheumatologists and Dermatologists. Use in accordance with NICE guidance for psoriatic arthritis (Aug 2010) Rituximab ‘Remsima’® 1st line for new patients and new episodes of care Consultant Rheumatologists only Use in accordance with local protocol and NICE guidance for rheumatoid arthritis (Aug 2010) Use in accordance with NICE guidance in combination with glucocorticoids for treatment of antineutrophil cytoplasmic antibodyassociated vasculitis (Mar 2014) Consultant Rheumatologists only Use in accordance with local protocol and NICE guidance For juvenile idiopathic arthritis (Dec 2011) For rheumatoid arthritis (Feb 2012) For juvenile idiopathic arthritis (Dec 2015) For rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (Jan 2016) Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 108 Tocilizumab NICE technology appraisal 195 NICE technology appraisal 308 MHRA Drug safety update Rituximab: screen for hepatitis B virus before treatment (Dec 2013) MHRA Drug safety update Tumour necrosis factor alpha inhibitors: risk of tuberculosis – screen all patients before starting treatment and monitor them closely (Apr 2014) NICE technology appraisal 238 NICE technology appraisal 247 NICE technology appraisal 373 NICE technology appraisal 375 Ustekinumab Consultant Rheumatologists and Dermatologists only. Use in accordance with local protocol and NICE guidance for treating active psoriatic arthritis (June 2015) NICE technology appraisal 340 MHRA Drug safety update Ustekinumab (Stelara): risk of exfoliative dermatitis (Jan 2015) Sulfasalazine Sulfasalazine (sulphasalazine) 10.1.4 Gout and cytotoxic-induced hyperuricaemia Acute attacks of gout Acute gout, 500mcg 2 – 4 times Colchicine daily until symptoms relieved Max 6mg per course Not to be repeated within 3 days Indometacin (indomethacin) Long-term control of gout Allopurinol Named patient supply only Probenecid Unlicensed medicine Hospital only Consultant Rheumatologists only Febuxostat Use in accordance with NICE guidance for chronic hyperuricaemia in gout (Dec 2008) MHRA Drug safety update Colchicine: reminder on risk of serious and fatal toxicity in overdose (Nov 2009) NICE technology appraisal 164 MHRA Drug safety update Febuxostat: stop treatment if signs or symptoms of serious hypersensitivity (eg, serious skin reactions or systemic hypersensitivity) occur (Jun 2012) Sulfinpyrazone Hyperuricaemia associated with cytotoxic drugs Consultant Haematologists only Rasburicase Use in accordance with local protocol PbR exclusion Hospital only 10.2 DRUGS USED IN NEUROMUSCULAR DISORDERS 10.2.1 Drugs that enhance neuromuscular transmission Anticholinesterases Unlicensed medicine Edrophonium chloride Neostigmine Pyridostigmine bromide Immunosuppressant therapy Unlicensed indication Azathioprine (see section 8.2.1) Unlicensed indication Ciclosporin (cyclosporine) (see ® ‘Deximune’® 1st line for new section 8.2.2) ‘Deximune ’, ® ® patients ‘Neoral ’, ‘Sandimmun ’ Corticosteroids (see section 6.3) Methotrexate (see section 8.1.3) Unlicensed indication Use in accordance with Trust protocol Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 109 - Prescribe by brand name MHRA Drug safety update Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) Ensure correct frequency of dosing 10.2.2 Skeletal muscle relaxants Baclofen Dantrolene Diazepam Tizanidine Nocturnal leg cramps Quinine sulfate Neurologists only MHRA Drug safety update Quinine: not to be used routinely for nocturnal leg cramps (Jun 2010) 10.3 DRUGS FOR THE TREATMENT OF SOFT TISSUE DISORDERS AND TOPICAL PAIN RELIEF 10.3 Extravasation Extravasation kits include:Dimethyl Sulfoxide 97% / 99% solution Hyaluronidase injection 1500 units Hydrocortisone 1% cream Hydrocortisone 100 mg intravenous injection Water for injection Sodium Chloride 0.9% Unlicensed medicine Hospital only 10.3.1 Enzymes Hyaluronidase injection 10.3.2 Rubefacients, topical NSAIDS, capsaicin and poultices Topical NSAIDs Ibuprofen 5% gel Capsaicin 0.075% in line with NICE guidelines Capsaicin 0.025% Pain Team Clinicians Poultices Kaolin poultice Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 110 - NICE clinical guideline 173 BNF SECTION 11 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 EYE Administration of drugs to the eye Control of microbial contamination Anti-infective eye preparations Corticosteroids and other anti-inflammatory preparations Mydriatics and cycloplegics Treatment of glaucoma Local anaesthetics Miscellaneous ophthalmic preparations Contact lenses 11.3 ANTI-INFECTIVE EYE PREPARATIONS 11.3 Anti-infective eye preparations 11.3.1 Antibacterials Preservative free minims available Chloramphenicol 0.5% eye drops Extemporaneous product Chloramphenicol 0.5% preservative Unlicensed medicine free eye drops (bottles) Hospital only Chloramphenicol 1% eye ointment Ophthalmologists only Amikacin eye drops rd 3 line in patients with severe resistant keratitis Extemporaneous product Unlicensed medicine Hospital only Ophthalmologists only, in patients Ceftazidime 5% preservative free with severe pseudomonal infection, eye drops resistant to alternative therapies Extemporaneous product Named patient supply only Unlicensed medicine Hospital only Extemporaneous product Cefuroxime 5% preservative free Unlicensed medicine eye drops Hospital only Ophthalmologists only for the Cefuroxime intercameral injection prevention of postoperative endophthalmitis following cataract surgery Extemporaneous product Unlicensed medicine Hospital only Ophthalmologists only Ciprofloxacin 0.3% eye ointment st 1 line for blepharitis Fusidic acid 1% eye drops nd 2 line for conjunctivitis) Preservative free bottles available Gentamicin 0.3% eye drops Extemporaneous product Gentamicin forte 1.5% eye drops Preservative free bottles available Unlicensed medicine Hospital only nd 2 line for keratitis resistant to Levofloxacin 0.5% eye drops ofloxacin) Ofloxacin 0.3% eye drops Ophthalmologists only Penicillin g (benzylpenicillin) 0.3% nd 2 line in patients with ocular preservative free eye drops streptococcal infection Extemporaneous product Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 111 - Vancomycin 11.3.2 Antifungals Amphotericin 0.15% eye drops Natamycin 5% eye drops 11.3.3 Antivirals Aciclovir (acyclovir) 3% eye ointment Ganciclovir 0.15% eye gel Named patient supply only Unlicensed medicine Hospital only Ophthalmologists only rd 3 line in patients with severe resistant keratitis. Extemporaneous product Unlicensed medicine Hospital only Ophthalmologists only, for treatment of fungal keratitis Extemporaneous product Unlicensed medicine Hospital only Ophthalmologists only, for fungal keratitis Unlicensed medicine Order when required Hospital only Ophthalmologists only, for use in acute herpetic keratitis in patients intolerant of ocular acyclovir Hospital only 11.4 CORTICOSTEROIDS AND OTHER ANTIINFLAMMATORY PREPARATIONS 11.4.1 Corticosteroids Betamethasone 0.1% eye drops Betamethasone 0.1% eye ointment Dexamethasone 0.1% eye drops ‘Maxidex’ Dexamethasone 0.1% preservative free minims Dexamethasone 0.1% preservative free eye drops (bottles) Fluorometholone 0.1% eye drops Loteprednol Etabonate 0.5% eye drops Prednisolone 0.03%, 0.1%, 0.3% Prednisolone 0.01% eye drops Prednisolone 0.5% and 1% eye drops Prednisolone 0.5% preservative free eye drops (bottles) Rimexolone 1% eye drops Tear duct surgery rd 3 line when used for cataract surgery with chloramphenicol Extemporaneous product Unlicensed medicine Hospital only Ophthalmologists only, for treatment of post-operative inflammation following ocular surgery Max duration of treatment 14 days With or without preservative Extemporaneous product Unlicensed medicines With or without preservative Extemporaneous product Unlicensed medicines Hospital only 0.5% preservative free minims available Extemporaneous product Unlicensed medicine Ophthalmologists only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 112 - Compound anti-inflammatories Betamethasone 0.1% with neomycin 0.5% eye drops Dexamethasone 0.05%, framycetin 0.5%, gramicidin 0.005% ‘Sofradex’® eye drops Dexamethasone 0.1%, neomycin 0.35% & polymyxin 6000 units/ g ‘Maxitrol’ eye drops Dexamethasone 0.1% with tobramycin 0.3% eye drops ‘Tobradex’® Intravitreal Corticosteroids Dexamethasone 700mcg intravitreal implant ‘Ozurdex’ Fluocinolone acetonide 190mcg intravitreal implant ‘Iluvien’ nd 2 line when used for cataract surgery st 1 line for cataract surgery Use in accordance with NICE guidance for macular oedema (retinal vein occlusion) (Jul 2011), and for treating diabetic macular oedema (July 2015) PbR exclusion Hospital only Use in accordance with NICE guidance for diabetic macular oedema (Nov 2013) PbR exclusion Hospital only 11.4.2 Other anti-inflammatory preparations Antazoline 0.5% with xylometazoline 0.05% eye drops ‘Otrivine-Antistin’ Non-seasonal and vernal kerato Nedocromil 2% eye drops ‘Rapitil’® conjunctivitis in patients > 6 years only Seasonal allergic conjunctivitis in Olopatadine 1 mg/ml eye drops patients >3 years nd 2 line to sodium cromoglicate) st 1 line for seasonal allergic Sodium cromoglicate 2% eye drops conjunctivitis st 1 line for seasonal allergic Sodium cromoglicate 2% preservative free eye drops (bottles) conjunctivitis Extemporaneous product Unlicensed medicine Hospital only 11.5 MYDRIATICS AND CYCLOPLEGICS 11.5 Mydriatics and cycloplegics Antimuscarinics Atropine 1% eye drops Atropine 1% preservative free eye drops (bottles) Cyclopentolate hydrochloride 0.5% and 1% eye drops Tropicamide 0.5% and 1% eye drops Sympathomimetics Phenylephrine hydrochloride 2.5% and 10% minims Preservative free minims available Extemporaneous product Unlicensed medicine Hospital only Preservative free minims available st 1 line Preservative free minims available nd 2 line Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 113 - NICE technology appraisal 229 NICE technology appraisal 349 NICE technology appraisal 301 11.6 TREATMENT OF GLAUCOMA See: Trust Algorithm for Medical Management of Primary Open-Angle Glaucoma (Jun 2014) Algorithm for Management of Glaucoma NICE guidance (Apr 2009) NICE clinical guideline 85 Beta-blockers For patients already initiated on Betaxolol 0.25% eye drops therapy only ‘Betoptic’® For patients already initiated on Levobunolol 0.5% eye drops therapy only ‘Betagan’® Preservative free minims available Timolol maleate 0.25% eye drops Timolol maleate 0.25% ‘TimoptolLA’® Preservative free minims available Timolol maleate 0.5% eye drops For patients already initiated on therapy only Prostaglandin analogues and prostamides Ophthalmologists only Bimatoprost 100mcg/ml eye drops nd 2 line Ophthalmologists only Bimatoprost 300mcg/ml eye drops nd 2 line Preservative free minims Bimatoprost 300 mcg/ml with timolol Preservative free minims available Ophthalmologists only 5 mg/ml ‘Ganfort’® nd 2 line st 1 line MHRA Drug safety update Latanoprost 50mcg/ml eye drops Latanoprost (Xalatan): increased reporting of eye irritation since reformulation (July 2015) Ophthalmologists only for use in Latanoprost 50mcg with timolol patients already stabilized on both 5mg/ml eye drops ‘Xalacom’ drugs in accordance with the management of glaucoma guidelines Ophthalmologists only Tafluprost 15mcg/ml eye drops nd 2 line Preservative free Ophthalmologists only Travoprost 40mcg/ml eye drops nd 2 line Ophthalmologists only for use in Travoprost 40mcg with timolol patients already stabilized on both 5mg/ml eye drops ‘DuoTrav’® drugs in accordance with the management of glaucoma guidelines Sympathomimetics Brimonidine tartrate 0.2% eye drops Ophthalmologists only for use in Brimonidine 0.2% with timolol 0.5% patients already stabilized on both ‘Combigan’® drugs in accordance with the management of glaucoma guidelines Carbonic anhydrase inhibitors and systemic drugs Acetazolamide 250mg tablets Acetazolamide 250mg MR capsules Brinzolamide 10mg/ml eye drops Ophthalmologists only Brinzolamide 10mg with timolol nd 5mg/ml eye drops ‘Azarga’® 2 line for use in those patients intolerant or non responsive to Cosopt® in line with the management of glaucoma guidelines for patients already initiated on Dorzolamide 2% eye drops Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 114 - therapy only Preservative free minims available Dorzolamide 2% with timolol 0.5% eye drops Miotics Pilocarpine 0.5%, 1%, 2%, 3%, 4% eye drops Pilocarpine 1%, 2%, 4%, 6% preservative free eye drops (bottles) 2% preservative free minims available Extemporaneous product Unlicensed medicines Hospital only 11.7 LOCAL ANAESTHETICS 11.7 Local anaesthetics Mydricaine number 1 & 2 subconjunctival injection Oxybuprocaine (benoxinate) 0.4% preservative free minims Proxymetacaine 0.5% preservative free minims Tetracaine (amethocaine) 0.5% and 1% preservative free minims Unlicensed medicine Hospital only st 1 line 11.8 MISCELLANEOUS OPHTHALMIC PREPARATIONS 11.8 Miscellaneous ophthalmic preparations Consultant Ophthalmologists use Retinoic acid (tretinoin) 0.05%, only preservative free eye drops Extemporaneous product Named patient supply only Unlicensed medicine Hospital only Ordered only when required 11.8.1 Tear deficiency, ocular lubricants and astringents See Dry Eye Protocol Extemporaneous product Acetylcysteine 10% eye drops Unlicensed medicine Hospital only Acetylcysteine 5% eye drops ‘Ilube’ Extemporaneous product Acetylcysteine 5% and 10% Unlicensed medicine, hospital only preservative free eye drops 2nd line treatment for mild dry eye Carbomers liquid gel eye drops symptoms in accordance with the ‘GelTears’, ‘Lumecare’® Dry Eye Protocol ‘Viscotears preservative free’® rd 3 line treatment for mild dry eye Carmellose sodium eye drops 0.5% symptoms in accordance with the eye drops ‘Optive’® Dry Eye Protocol For moderate dry eye if signs of Carmellose sodium eye drops 0.5% allergy/intolerance in accordance and 1% preservative free minims with the Dry Eye Protocol ‘Celluvisc’ Consultant Ophthalmologist initiation Ciclosporin 0.1% preservative free only minims ‘Ikervis’® Last line option in severe dry eye conditions in accordance with NICE guidance for treating dry eye disease that has not improved despite treatment with artificial tears Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 115 - NICE technology appraisal 369 Ciclosporin 0.05% preservative free minims Hypromellose 0.3% eye drops Hypromellose 0.3% preservative free eye drops Hypromellose viscous 1% eye drops Liquid paraffin eye ointment ‘LacriLube’ Liquid paraffin and vitamin A eye ointment ‘VitA-POS’® Macrogol and mineral oil eye drops ‘Systane Ultra’® Macrogol and mineral oil preservative free minims ‘Systane Ultra minims’® Macrogol and mineral oil gel eye drops ‘Systane Ultra Gel’® Mineral oil and lipid eye drops ‘Systane Balance’® Paraffin, yellow soft ‘Simple Eye Ointment’® Polyvinyl alcohol 1.4% eye drops Sodium chloride 0.9% eye drops Sodium chloride 5% eye ointment (Dec 2015) and the Dry Eye Protocol Shared care guidance available for specific CCGs Consultant Ophthalmologist initiation only Last line option in severe dry eye conditions for patients unable to tolerate the higher strength licensed preparation Extemporaneous product Unlicensed medicine Hospital only st 1 line treatment for mild dry eye if signs of allergy/intolerance in accordance with the Dry Eye Protocol For moderate dry eye if signs of allergy/intolerance in accordance with the Dry Eye Protocol Extemporaneous product Unlicensed medicine Hospital only For night time treatment of moderate dry eye in accordance with the Dry Eye Protocol For night time treatment of moderate dry eye in accordance with the Dry Eye Protocol rd 3 line treatment for mild dry eye symptoms in accordance with the Dry Eye Protocol For moderate dry eye if signs of allergy/intolerance in accordance with the Dry Eye Protocol For night time treatment of moderate dry eye is patient is unable to apply an ointment rd 3 line treatment for mild dry eye symptoms with meibomian gland dysfunction in accordance with the Dry Eye Protocol For night time treatment of moderate dry eye in accordance with the Dry Eye Protocol 2nd line treatment for mild dry eye symptoms in accordance with the Dry Eye Protocol Preservative free minims available: For moderate dry eye if signs of allergy/intolerance in accordance with the Dry Eye Protocol Preservative free minims available Extemporaneous product Unlicensed medicine, hospital only Sodium chloride 5% preservative free eye drops Sodium chloride balanced salt solution 15ml and 500ml Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 116 - NHS Surrey Shared Care Sodium hyaluronate 0.075% rinsing solution ‘Vismed wash’® Sodium hyaluronate 0.1% eye drops ‘Hylo-Tear’® Consultant Ophthalmologist initiation only, for the removal of abnormal secretions and filaments in accordance with the Trust Dry Eye Protocol Hospital only Consultant Ophthalmologist initiation only for the treatment of severe dry eyes in accordance with the Trust Dry Eye Protocol Consultant Ophthalmologist initiation only for the treatment of severe dry eyes in accordance with the Trust Dry Eye Protocol Sodium hyaluronate 0.2% eye drops Consultant Ophthalmologist initiation only for the treatment of severe dry ‘Hylo-Forte’® eyes in accordance with the Trust Dry Eye Protocol Sodium hyaluronate 0.4% eye drops Consultant Ophthalmologist initiation only for the treatment of severe dry ‘Clinitas’® eyes in accordance with the Trust Dry Eye Protocol 11.8.2 Ocular diagnostic and peri-operative preparations and photodynamic treatment Ocular diagnostic preparations Fluorescein 1% and 2% preservative free minims Fluorescein 1mg strips Use in accordance with Moorfields Indocyanine green injection Eye Hospital Adult Intravenous Indocyanine Green Angiography policy Ophthalmologists only, for use in the Lissamine green 1.5mg eye strips Specialist Corneal Clinics Unlicensed medicine Hospital only Ocular peri-operative drugs Acetylcholine 1% intra-ocular irrigation ‘Miochol E’ Apraclonidine 0.5% eye drops and 1% preservative free minims Ophthalmologists only Bromfenac 0.09% eye drops Full 12 week supply from the Trust ‘Yellox’® Diclofenac sodium 0.1% preservative free minims Unlicensed medicine Disodium edetate 0.37% eye drops Hospital only Flurbiprofen 0.03% eye drops ‘Ocufen’ Hydroxypropyl methylcellulose 2% in balanced salt solution ‘HPMC’® nd 2 line if bromfenac not tolerated Ketorolac trometamol 0.5% eye Opthalmologists only drops ‘Acular’® Full 12 week supply from the Trust Extemporaneous product Potassium ascorbate 10% Unlicensed medicine preservative free eye drops Hospital only To be used before eye surgery and Povidone iodine eye drops 5% suture removal after ocular surgery One bottle per clinic/list with new sterile dropper for each patient Sodium hyaluronate 0.18% eye drops ‘Vismed’® Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 117 - Ophthalmologists only Sodium hyaluronate intra ocular injection ‘Healonid’ and ‘Healonid 5’ Ophthalmologists only, for posterior Sodium Chondroitin/Sodium capsular rupture Hyaluronate ‘Viscoat’® Subfoveal choroidal neovascularisation Use in accordance with NICE Aflibercept guidance for wet age-related macular degeneration (Jul 2013) and local CCG guidance Use in accordance with NICE guidance for treating visual impairment caused by macular oedema secondary to central vein occlusion (Feb 2014), and for treating diabetic macular oedema (July 2015) PbR exclusion Hospital only Ranibizumab Use in accordance with NICE guidance for age-related macular degeneration (Aug 2008) Use in accordance with NICE guidance for diabetic macular oedema (Feb 2013) Use in accordance with NICE guidance for treating visual impairment caused by macular oedema secondary to retinal vein occlusion (May 2013) Use in accordance with NICE guidance for pathological myopia (Dec 2013) PbR exclusion Hospital only Vitreomacular traction Ocriplasmin Use in accordance with NICE guidance for vitreomacular traction (Oct 2013) PbR exclusion Hospital only Botulinum A toxin-haemagglutinin complex Consultant Ophthalmologists only, Botulinum toxin type A ‘Botox’ for blepharospasm and squint (unlicensed indication) PbR exclusion Hospital only Skin tissue adhesive Consultant ophthalmologists only Enbucrilate Blue tissue adhesive Use only in the emergency setting to seal corneal holes when sutures are not suitable according to local protocol Consultant ophthalmologists only Tisseel (Fibrin Glue) sealant Use only in patients with corneal perforations where sutures are not suitable or for patients undergoing pterygium surgery Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 118 - NICE technology appraisal 294 Surrey Prescribing Clinical Network NICE technology appraisal 305 NICE technology appraisal 346 MHRA Drug safety update Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw (April 2016) NICE technology appraisal 155 NICE technology appraisal 274 NICE technology appraisal 283 NICE technology appraisal 298 NICE technology appraisal 297 MHRA Drug safety update Botulinum toxin products: rare but serious risk (Oct 2007) 11.9 CONTACT LENSES 11.9 Contact lenses Acanthamoeba Keratitis Chlorhexidine 0.02% eye drops Chlorhexidine 0.2% eye drops Polyhexamethylene biguanide (PHMB) 0.02% eye drops Polyhexamethylene biguanide (PHMB) 0.06% eye drops Hexamidine 0.1% eye drops Ophthalmologists only, in patients with acanthamoeba keratitis Extemporaneous product Unlicensed medicine Hospital only Ordered only when required Ophthalmologists only, in patients with acanthamoeba keratitis unresponsive to the 0.02% eye drops Extemporaneous product Unlicensed medicine Hospital only Ordered only when required Ophthalmologists only, in patients with acanthamoeba keratitis Extemporaneous product Unlicensed medicine Hospital only Ordered only when required Ophthalmologists only, in patients with acanthamoeba keratitis unresponsive to the 0.02% eye drops Extemporaneous product Unlicensed medicine Hospital only Ordered only when required Ophthalmologists only, in patients with acanthamoeba keratitis Extemporaneous product Unlicensed medicine Hospital only Ordered only when required Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 119 - BNF SECTION 12 EAR, NOSE AND OROPHARYNX 12.1 Drugs acting on the ear 12.2 Drugs acting on the nose 12.3 Drugs acting on the oropharynx 12.1 DRUGS ACTING ON THE EAR 12.1.1 Otitis externa Anti-inflammatory preparations Betamethasone 0.1% ear drops Prednisolone 0.5% ear drops ‘Predsol’ Anti-inflammatory with antibacterial preparations Betamethasone 0.1% with neomycin 0.5% ear drops Dexamethasone 0.05% with framycetin 0.5% and gramicidin 0.005% ear drops ‘Sofradex’ Dexamethasone 0.1% with neomycin 3250units/ml and glacial acetic acid 2% ear spray ‘Otomize’ Flumetasone 0.02% with clioquinol 1% ear drops ‘Locorten-Vioform’ Hydrocortisone 1% with gentamicin 0.3% ear drops ‘Gentisone HC’ ENT clinicians only ‘Tri-Adcortyl Otic’® Extemporaneous product Unlicensed Medicine, hospital only Anti-infective preparations Chloramphenicol 10% ear drops For use in the ear, by ENT Clinicians Ofloxacin 0.3% eye drops only Unlicensed indication Clotrimazole 1% solution Gentamicin 0.3% eardrops 12.1.2 Otitis media ‘Otovent’® device 12.1.3 Removal of ear wax ‘Cerumol’ ear drops ‘Exterol’ ear drops Olive oil ear drops Sodium bicarbonate 5% ear drops ENT clinicians only in accordance with NICE guidance for Otitis media (Feb 2008) NICE clinical guideline CG60 st 1 line st 1 line 12.2 DRUGS ACTING ON THE NOSE 12.2.1 Drugs used in nasal allergy Corticosteroids MHRA Drug safety update Inhaled and intranasal corticosteroids: risk of psychological and behavioural side effects (Sep 2010) st 1 line in adults Beclomethasone dipropionate 50 mcg nasal spray Betamethasone 0.1% nasal drops Fluticasone 50mcg aqueous nasal spray Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 120 - Fluticasone furoate 27.5mcg nasal spray ‘Avamys’® Mometasone 50mcg aqueous nasal spray ‘Nasonex’® Cromoglicate Sodium cromoglicate 4% nasal spray Immunologists and paediatricians only ENT Clinicians only 12.2.2 Topical nasal decongestants Sympathomimetics Ephedrine 0.5% and 1% nasal drops Xylometazoline 0.1% nasal drops and 0.1% nasal spray and 0.05% paediatric nasal drops Antimuscarinic Ipratropium bromide 0.03%, 21mcg/dose nasal spray ‘Rinatec’® Others Sodium chloride 0.9 % aerosol nasal spray Sodium chloride 0.9% nasal drops MHRA Drug safety update Pseudoephedrine and ephedrine: update on managing risk of misuse in the UK (Sept 2015) ENT Clinicians only 12.2.3 Nasal preparations for infection Betamethasone 0.1% & neomycin 0.5% nasal drops Nasal staphylococci See MRSA skin suppression Chlorhexidine 0.1% & neomycin protocol (mupirocin resistant strains) 0.5% cream ‘Naseptin’ See MRSA skin suppression Mupirocin 2% nasal ointment protocol ‘Bactroban Nasal’® See MRSA skin suppression ‘Prontoderm’® nasal gel protocol. Prontoderm® to be used for patients allergic to chlorhexidine MRSA eradication (see section 5) Epistaxis Bismuth subnitrate and iodoform bandage Others Respiratory Consultants only Tobramycin nasal drops Extemporaneous product Unlicensed medicine Hospital only Contains arachis (peanut) oil 12.3 DRUGS ACTING ON THE OROPHARYNX 12.3.1 Drugs for oral ulceration and inflammation Benzydamine 0.15% spray (Paediatricians only), 0.15% oral rinse ‘Difflam’ Children under 16 years Calgel teething gel’® Carmellose sodium oral paste ‘Orabase’ Adults and children over 16 years Choline salicylate oral gel BP Hydrocortisone sodium succinate Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 121 - MHRA Drug safety update Oral salicylate gels: not for use in those younger than age 16 years (Jun 2009) 2.5 mg oromucosal tablets 12.3.2 Oropharyngeal anti-infective drugs Miconazole 20 mg/g oral gel Nystatin 100,000 units/ml oral suspension 12.3.3 Lozenges and sprays Benzalkonium oral lozenges ‘Bradosol’ Benzalkonium + dequalinium oral lozenges ‘Dequacaine’® Dequalinium oral lozenges ‘Dequadin’ 12.3.4 Mouthwashes, gargles and dentifrices Chlorhexidine 1% dental gel and 0.2% mouthwash Hydrogen peroxide 10 vol. 3% mouthwash 12.3.5 Treatment of dry mouth Saliva (artificial) lozenges ‘AS Saliva Orthana’ Saliva (artificial) spray Concentrated oral gel rinse ‘Gelclair’® nd 2 line Palliative Care Team only Hospital only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 122 - MHRA Drug safety update Topical miconazole, including oral gel: reminder of potential for serious interactions with warfarin (June 2016) BNF SECTION 13 13.1 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 13.10 13.11 13.12 13.13 SKIN Management of skin conditions Emollient and barrier preparations Topical local anaesthetics and antipruritics Topical corticosteroids Preparations for eczema and psoriasis Acne and rosacea Preparations for warts and calluses Sunscreens and camouflagers Shampoos and other preparations for scalp and hair conditions Anti-infective skin preparations Skin cleansers, antiseptics and desloughing agents Antiperspirants Topical circulatory preparations 13.2 EMOLLIENT AND BARRIER PREPARATIONS MHRA Drug safety update Paraffin-based skin emollients on dressings or clothing: fire risk (April 2016) 13.2.1 Emollients - See Trust guidance for the use of Emollients in dry skin conditions. (L) = ‘Light or creamy emollient (R) = ‘Rich’ cream type emollient (G) = ‘Greasy’ emollient First Line MHRA Drug safety update Aqueous cream, BP (L) Aqueous cream: may cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content (Mar 2013) Hydrous ointment, BP (R) Liquid Paraffin 50% in White Soft Paraffin 50% ointment (G) Second Line ‘E45’ cream (L) ‘Ultrabase’ cream (L/R) Paraffin, White Soft, BP (G) Obtain via purchasing and logistics Paraffin, Yellow Soft, BP (G) Emulsifying ointment, BP (G) Third Line ‘Diprobase’ cream (L) ‘Unguentum M’ cream (R) ‘Epaderm’ ointment (G) Emollients containing Urea Dermatologists only Balneum plus’® cream Urea cream 10% Emollients with antimicrobials ‘Dermol 500’ lotion 13.2.1.1 Emollient bath and shower preparations ‘Aveeno’ bath oil Paediatricians and Dermatologists ‘Balneum Plus’ bath oil only ‘Hydromol’® bath and shower emollient Emollient bath and shower preparations with antimicrobials Dermatologists only ‘Oilatum Plus’ Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 123 - 13.2.2 Barrier Preparations Cavilon preparations must be prescribed by a Medical Practitioner or Tissue Viability Nurse Specialist only Unbroken skin ‘Cavilon’ cream Broken skin ‘Cavilon’ barrier foam ‘wands’ Broken skin on recommendation by ‘Cavilon’ spray Tissue Viability Nurse Specialists only except intensive care wards In paediatrics for moderate to ‘Metanium’ severe nappy rash Paediatric patients only Zinc and castor oil ointment, BP Obtain via purchasing and logistics 13.3 TOPICAL LOCAL ANAESTHETICS AND ANTIPRURITICS 13.3 Topical local anaesthetics and antipruritics Obtain via purchasing and logistics Calamine lotion Crotamiton cream 10% ‘Eurax’ Menthol 1% in aqueous cream ‘Dermacool’® 13.4 TOPICAL CORTICOSTEROIDS Corticosteroid preparations (betamethasone, clobetasol, clobetasone and mometasone) with additional compounds e.g. salicylic acid, coal tar, propylene glycol, sulphur etc are extemporaneously prepared, and are therefore unlicensed. These medicines must be obtained from the hospital 13.4 Topical corticosteroids See NICE guidance on the frequency of application of topical steroids for atopic dermatitis (Aug 2004) NICE technology appraisal 81 Mild Hydrocortisone 0.5% and 1% cream/ointment With antimicrobials Hydrocortisone 0.5%, nystatin 100,000 units/gm cream ‘Timodine’ Hydrocortisone 1%, clotrimazole 1% cream ‘Canesten HC’ Dermatologists only Hydrocortisone 1%, fusidic acid 2% cream ‘Fucidin H’ Hydrocortisone 1%, miconazole 2% cream/ointment ‘Daktacort’ With crotamiton Hydrocortisone 0.25%, crotamiton 10% cream ‘Eurax-Hydrocortisone’ Moderate Betamethasone valerate 0.025% cream/ointment ‘Betnovate-RD’® Clobetasone butyrate 0.05% cream/ointment ‘Eumovate’ Fludroxycortide/flurandrenolone ‘Haelan’ tape only Fluocinolone acetonide 0.00625% cream/ointment ‘Synalar 1 in 4 dilution’® With antimicrobials Clobetasone 0.05%, oxytetracycline Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 124 - 3%, nystatin 100,000 units/gm cream ‘Trimovate’ With urea Hydrocortisone 1%, urea 10% cream ‘Alphaderm’ Potent Betamethasone valerate 0.1%, cream/ointment and scalp application Betamethasone diproprionate 0.05% cream/ointment ‘Diprosone’ Mometasone furoate 0.1% cream/ointment ‘Elocon’ Hydrocortisone butyrate 0.1% cream/ointment ‘Locoid’ Fluocinolone acetonide 0.025% cream/ointment and gel ‘Synalar’ With antimicrobials Betamethasone valerate 0.1%, clioquinol 3% cream/ointment ‘Betnovate-C’ Betamethasone valerate 0.1%, fusidic acid 2% cream ‘Fucibet’ Betamethasone dipropionate 0.05%, clotrimazole 1% cream ‘Lotriderm’® With salicylic acid Betamethasone dipropionate 0.05%, salicylic acid 3% ointment ‘Diprosalic’ Very potent Clobetasol propionate 0.05% cream/ointment/scalp application ‘Dermovate’ Clobetasol propionate 0.05% shampoo ‘Etrivex’® Dermatologists only Dermatologists only Dermatologists only Dermatologists only nd 2 line 13.5 PREPARATIONS FOR ECZEMA AND PSORIASIS 13.5.1 Preparations for eczema Oral retinoid for eczema Alitretinoin ‘Toctino’® Consultant Dermatologists only Use in accordance with NICE guidance for severe chronic hand eczema (Aug 2009) PbR exclusion Hospital only NICE technology appraisal 177 MHRA Drug safety update Oral retinoids: pregnancy prevention—reminder of measures to minimise teratogenic risk (Jun 2013) Pregnancy prevention programme to be followed 13.5.2 Preparations for psoriasis See NICE guidelines for the treatment of psoriasis NICE clinical guideline 153 Topical preparations for psoriasis Vitamin D and analogues Calcipotriol 50mcg/g ointment ‘Dovonex’® Dermatologists only Calcipotriol 50mcg/g with betamethasone 0.05% ointment Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 125 - ‘Dovobet’® Calcipotriol 50mcg/g with betamethasone 0.05% gel ‘Dovobet’® Calcipotriol 50mcg/g with betamethasone 0.05% gel ‘Dovobet’® gel with applicator Calcitriol 3mcg/g ointment ‘Silkis’® Tazarotene Tazarotene 0.05% gel Tars Coal tar and salicylic acid ointment, BP Coconut compound scalp ointment ‘Cocois’® ‘Polytar emollient’® bath additive Dithranol ‘Dithrocream’®, 0.1%, 0.25%, 0.5%, 1%, 2% ‘Micanol’ cream 3% strength only Salicylic acid Zinc and Salicylic Acid Paste, BP (Lassar’s Paste) Oral retinoids for psoriasis Acitretin Dermatologists only For patients who are unable to tolerate betamethasone or clobetasol scalp preparations Dermatologists only For patients with scalp psoriasis or psoriasis in difficult to reach areas Dermatologists only Dermatologists only Hospital only MHRA Drug safety update Oral retinoids: pregnancy prevention—reminder of measures to minimise teratogenic risk (Jun 2013) Pregnancy prevention programme to be followed 13.5.3 Drugs affecting the immune response Dermatologists and Immunologists Ciclosporin (cyclosporin) capsules ® ® only. ‘Deximune ’, ‘Neoral ’, ® ‘Sandimmun ’ ‘Deximune’® 1st line for new patients Methotrexate tablets Pimecrolimus 1% cream Tacrolimus topical 0.03%, 0.1% Use in accordance with Trust protocol Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Initiation by Dermatologists only To be prescribed by dermatologists and paediatricians only in accordance with NICE guidance Tacrolimus and Pimecrolimus for moderate atopic eczema (Aug 2004) Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Initiation by Dermatologists only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 126 - Prescribe by brand name MHRA Drug safety update Ciclosporin: must be prescribed and dispensed by brand name (Dec 2009) Ensure correct frequency of dosing NICE technology appraisal 82 NICE technology appraisal 82 ointment Cytokine modulators Adalimumab Etanercept ‘Enbrel’®, Benepali’® Infliximab ‘Remicade’®, ‘Remsima’® Ustekinumab Secukinumab To be prescribed by dermatologists and paediatricians only in accordance with NICE guidance Tacrolimus and Pimecrolimus for moderate to severe atopic eczema (Aug 2004) Shared care guidance available for specific CCGs – Contact Medicines Management Team on Ext: 701 6075/721 4037/721 4038 for further details Consultant Dermatologists only Use in accordance with NICE guidance for plaque psoriasis (Jun 2008) Use in accordance with NICE guidance for treating moderate to severe hidradenitis suppurativa (June 2016) Funding by specialist centres only. PbR exclusion Hospital only Consultant Dermatologists only, in accordance with NICE guidance for plaque psoriasis (Jul 2006) PbR exclusion Hospital only Consultant Dermatologists only Use in accordance with NICE guidance for plaque psoriasis (Jan 2008) PbR exclusion Hospital only st ‘Remsima’® 1 line for new patients and new episodes of care Consultant Dermatologists only, in accordance with NICE guidance for plaque psoriasis (Sep 2009) PbR exclusion Hospital only Consultant Dermatologists only, in accordance with NICE guidance for treating moderate to severe plaque psoriasis (July 2015) PbR exclusion Hospital only 13.6 ACNE AND ROSACEA 13.6.1 Topical preparations for acne Benzoyl peroxide and azelazic acid Dermatologists only Benzoyl peroxide 4% cream ‘Brevoxyl’ Topical antibacterials for acne Clindamycin 1% topical solution ‘Dalacin T’ Dermatologists only Clindamycin 0.1% and tretinoin 0.025% gel Treclin® Erythromycin 40mg, zinc acetate 12mg/ml topical solution ‘Zineryt’ Topical retinoids and related preparations for acne Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 127 - MHRA Drug safety update Tacrolimus ointment: reminder of a possible risk of malignancies including lymphomas and skin cancers (Jun 2012) NICE technology appraisal 146 NICE technology appraisal 392 NICE technology appraisal 103 Prescribe by brand name NICE technology appraisal 134 Prescribe by brand name NICE technology appraisal 180 MHRA Drug safety update Ustekinumab (Stelara): risk of exfoliative dermatitis (Jan 2015) NICE technology appraisal 350 Adapalene 0.1% gel 13.6.2 Oral preparations for acne Oral antibacterials for acne See section 5.1 Hormone treatment for acne Co-cyprindiol MHRA Drug safety update Cyproterone acetate with ethinylestradiol (co-cyprindiol): updated prescribing advice provided (Jun 2013) MHRA Drug safety update Cyproterone acetate with ethinylestradiol (co-cyprindiol): recommended duration of use (Apr 2008) Oral retinoid for acne Isotretinoin Consultant Dermatologists only Hospital only Pregnancy prevention programme to be followed MHRA Drug safety update Oral retinoids: pregnancy prevention—reminder of measures to minimise teratogenic risk (Jun 2013) MHRA Drug safety update Isotretinoin: risk of serious skin reactions (Sep 2010) MHRA Drug safety update Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders—warn patients and family; monitor patients for signs of depression (Dec 2014) 13.6.3 Topical preparations for rosacea Dermatologists only, for moderate to Ivermectin 1% cream ‘Soolantra®’ severe rosacea (papulopustular) nd 2 line Dermatologists only, for acne Metronidazole cream 0.75% rosacea 13.7 PREPARATIONS FOR WARTS AND CALLUSES 13.7 Preparations for warts and calluses Salicylic acid paint ‘Salactol’, cutaneous solution ‘Occlusal’ Silver nitrate caustic pencils 95% ‘Avoca’ Anogenital warts Extemporaneous product Acetic acid 5% solution Unlicensed medicine Hospital only Extemporaneous product Formaldehyde 10% solution Unlicensed medicine Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 128 - COSHH Regulations category 1B Carcinogen- Special handling Formaldehyde 4% solution Imiquimod 5% cream ‘Aldara’ Podophyllotoxin 0.5% solution ‘Warticon’ Podophyllum paint, Compound, BP Hospital only Dermatologists only Extemporaneous product Unlicensed medicine Hospital only GU Medicine only Dermatologists and Plastic Surgeons for lentigo maligna Unlicensed indication Hospital only precautions required. COSHH Regulations category 1B Carcinogen- Special handling precautions required. Unlicensed medicine Hospital only 13.8 SUNSCREENS AND CAMOUFLAGERS 13.8.1 Sunscreening preparations ‘Uvistat’ cream (UVA & UVB protection; UVB-SPF 30) Photodamage 5- aminolaevulinic acid gel ‘Ameluz’® Diclofenac sodium 3% gel ‘Solaraze’® Fluorouracil 5% cream Fluorouracil 0.5%, salicylic acid 10% solution ‘Actikerall’ Ingenol mebutate 150micrograms/g gel, 500micrograms/g gel ‘Picato’ Methyl-5-aminolevulinate hydrochloride cream ‘Metvix’ Photodynamic Therapy 5-Methoxypsoralen 8- Methoxypsoralen 13.8.2 Camouflagers ‘Dermacolour’® Hydroquinone monobenzone compounded preparations 10%, 15%, 20%, 30% Hydroquinone compounded preparations 2%, 4% Dermatologists only Hospital only Dermatologists only The 12 week treatment course to be supplied from the Trust. GP’s can supply subsequent courses if needed or refer back to secondary care for a dermatology opinion. Dermatologists only Hospital only Dermatologists only Hospital only Dermatologists only Hospital only Dermatologists only Hospital only Unlicensed medicine Hospital only Unlicensed medicine Hospital only Extemporaneous product Unlicensed medicine Hospital only Extemporaneous product Unlicensed medicine Hospital only 13.9 SHAMPOOS AND OTHER PREPARATIONS FOR SCALP AND HAIR CONDITIONS 13.9 Shampoos and other preparations for scalp and hair conditions ‘Alphosyl 2 in1’® shampoo ‘Capasal’ shampoo Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 129 - 150micrograms/g- for face and scalp 500micrograms/g- for trunk and extremities Coal tar shampoo ‘Polytar’ Coconut compound scalp ointment Ketoconazole 2% shampoo Male pattern baldness Diphencyprone in acetone Dermatologists only Extemporaneous product Unlicensed medicine Hospital only Hirsutism Co-cyprindiol MHRA Drug safety update Cyproterone acetate with ethinylestradiol (co-cyprindiol): updated prescribing advice provided (Jun 2013) MHRA Drug safety update Cyproterone acetate with ethinylestradiol (co-cyprindiol): recommended duration of use (Apr 2008) 13.10 ANTI-INFECTIVE SKIN PREPARATIONS 13.10.1 Antibacterial preparations 13.10.1.1 Antibacterial preparations only used topically Mupirocin 2% ointment ‘Bactroban’ MRSA patients only Ordered only when required Silver sulfadiazine 1% cream ‘Flamazine’ 13.10.1.2 Antibacterial preparations also used systemically Fusidic acid 2% cream ‘Fucidin’ Dermatologists only, for acne Metronidazole cream 0.75% rosacea For malodorous wounds Metronidazole gel 0.75% 13.10.2 Antifungal preparations Amorolfine 5% nail lacquer Benzoic acid ointment, compound, BP ‘Whitfield’s ointment’ Clotrimazole 1% cream and solution Ketoconazole 2% cream Miconazole 2% cream Terbinafine 1% cream Dermatologists only Dermatologists only 13.10.3 Antiviral preparations Aciclovir (acyclovir) 5% cream 13.10.4 Parasiticidal preparations Ivermectin (oral) for resistant scabies Consultant Dermatologists only Named patient supply only Unlicensed medicine Hospital only Malathion 0.5% aqueous solution ‘Derbac M’ Permethrin 1% cream rinse and 5% dermal cream ‘Lyclear’ 13.10.5 Preparations for minor cuts and abrasions Flexible collodion, BP Magnesium sulfate paste, BP Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 130 - Proflavine cream, BPC Skin tissue adhesive Enbucrilate tissue adhesive ‘Histoacryl’® +/- Lipiodol for bleeding gastric varices Unlicensed medicine Obtain via purchasing and logistics Obtain direct from endoscopy 13.11 SKIN CLEANSERS AND ANTISEPTICS Patient Safety Alert Risk of death or severe harm due to inadvertent injection of skin preparation solution (May 2015) 13.11.1 Alcohols and saline Obtain via purchasing and logistics Alcoholic hand rub Obtain via purchasing and logistics Industrial methylated spirit, BP 70% Surgical spirit, BP Obtain via purchasing and logistics Sodium chloride 0.9% solution ‘Normasol’ Sodium chloride 0.9% solution ‘Irriclens’ 13.11.2 Chlorhexidine salts See MHRA Drug safety update Chlorhexidine: reminder of potential for hypersensitivity (Jan 2012) MHRA Drug safety update Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants (Nov 2014) Chlorhexidine 1% cream ‘Hibitane Obstetric’ Chlorhexidine 1% powder ‘CX See MRSA surgical pre-assessment Antiseptic Dusting Powder’® protocol Obtain via purchasing and logistics Chlorhexidine 0.5% hand rub ‘Hydrex’ Obtain via purchasing and logistics Chlorhexidine in IMS 0.5% ‘Hydrex’ (pink and clear) Obtain via purchasing and logistics Chlorhexidine gluconate 2% in isopropyl alcohol 70% ‘ChloraPrep’® Chlorhexidine cleansing solution 4% ‘Hibiscrub’ 250ml Chlorhexidine cleansing solution 4% Obtain via purchasing and logistics ‘Hibiscrub’® 500ml With cetrimide A&E Department only Chlorhexidine gluconate 0.015% & Obtain via purchasing and logistics cetrimide 0.15% sachets ‘Tisept’ 13.11.4 Iodine Iodine tincture, BP Povidone iodine 1.14% antiseptic spray ‘Savlon Dry Antiseptic’®, 10% ointment, 2.5% dry powder spray ‘Betadine’® Povidone iodine 10% solution alcoholic/antiseptic, 7.5% surgical scrub Other Sodium hypochlorite (sterilising fluid) liquid Obtain via purchasing and logistics Obtain via purchasing and logistics 13.11.6 Oxidisers and dyes Hydrogen peroxide 3% (10 vols.), 6% (20 vols.) solution Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 131 - MHRA Drug safety update Hydrogen peroxide: reminder of risk of gas embolism when used in surgery–do not use in closed body cavities or on deep or large wounds (Dec 2014) Hydrogen peroxide 1% cream ‘Crystacide’® Potassium permanganate solution tablets 400 mg ‘Permitabs’ Ordered only when required for Toxic Epidermal Necrolysis Patient safety alert Risk of death or serious harm from accidental ingestion of potassium permanganate preparations (Dec 2014) 13.11.7 Preparations for promotion of wound healing Desloughing agents Tissue Viability Nurse Specialists Larval Therapy and podiatry only 13.12 ANTIPERSPIRANTS 13.12 Antiperspirants Aluminium chloride 20% application Botulinum toxin type A Consultant Dermatologists and Vascular Surgeons only for hyperhidrosis PbR exclusion Hospital only MHRA Drug safety update Botulinum toxin products: rare but serious risk (Oct 2007) 13.13 TOPICAL CIRCULATORY PREPARATIONS 13.13 Topical circulatory preparations Heparinoid 0.3% cream ‘Hirudoid’ WOUND MANAGEMENT PRODUCTS AND ELASTIC HOSIERY WOUND MANAGEMENT PRODUCTS See Trust Wound Management Guidelines for further information. Patients who require wound management products upon discharge must be given 5 days discharge supply. Wound dressings Low adherence dressings ‘NA-Ultra’® Paraffin Gauze Dressing, BP Absorbent dressings ‘Mepore’® ‘Primapore’® Hydrogel dressings ‘GranuGel’ ‘ActiFormCool’® Obtain via purchasing & logistics For theatre use only, not used as a dressing. Tissue viability nurse directive in accordance with NICE guidance on the management of pressure ulcers (Sept 2005) Obtain via purchasing & logistics Obtain via purchasing & logistics ST 1 line Tissue Viability Nurse Specialist only nd 2 line ITU/Tissue Viability Nurse Specialist ‘Geliperm’ only For use with topical diamorphine ‘Intrasite’ 15g only Vapour- permeable films and membranes Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 132 - NICE clinical guideline 29 ‘Mepore film’ ‘OpSite’ spray A&E, Dermatology, Paediatric departments and Theatres only Soft polymer dressings without absorbent pad ‘Adaptic Touch’® Soft polymer dressings with absorbent pad Tissue Viability Nurse Specialist only ‘Sorbion Sana’® Hydrocolloid dressings ‘Aquacel’® Extra ‘Aquacel’® Ribbon ‘DuoDERM’ Extra Thin ‘DuoDERM’ Signal ‘Aquacel’® Foam Non-Adhesive ‘Aquacel’® Foam Adhesive Foam dressings Tissue Viability Nurse Specialist or ‘Allevyn’ Surgeons only Alginate dressings ‘Kaltostat’ Odour Absorbent Dressings ‘CarboFLEX’ Iodine ‘Iodoflex’ ‘Iodosorb’ Povidone iodine ‘Inadine’ Silver ‘Acticoat’® Other antimicrobials Chlorhexidine Gauze Dressing, BP Protease modulating matrix Protease modulating matrix ‘Promogran’ Medicated Bandages Zinc Paste + Ichthammol bandage, BP ‘Ichthopaste’ Zinc Paste bandage, BP ‘Steripaste’, ‘Viscopaste’ Miscellaneous ‘Iodophor’ ‘Spongostan’ Surgicel’ Tissue Viability Nurse Specialist or Surgeons only For infected or heavily colonised wounds Tissue Viability Nurse Specialist or Surgeons only For infected or heavily colonised wounds Tissue Viability Nurse Specialist or Surgeons only For infected and heavily colonised wounds and for partial full dermal thickness burns Hospital only Chiropody only Tissue viability Nurse Specialists only For continuation of therapy initiated elsewhere. Obtain via purchasing and logistics Theatre use only Theatre use only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 133 - BNF SECTION 14 14.1 14.2 14.3 14.4 14.5 14.6 IMMUNOLOGICAL PRODUCTS AND VACCINES Active immunity Passive immunity Storage and use Vaccines and antisera Immunoglobulins International travel 14.4 VACCINES AND ANTISERA MHRA Drug safety update Live attenuated vaccines: avoid use in those who are clinically immunosuppressed (April 2016) BCG vaccines Bacillus Calmette Guérin vaccine intradermal vaccination (Live) Diagnostic agents Tuberculin PPD 2 units per 0.1ml (20units/ml) for routine test Tuberculin PPD 10 units per 0.1ml (100units/0.1ml) for re-test only Botulism antitoxin Epsom hospital is a designated Botulism antitoxin trivalent (Equine) holding centre Diphtheria vaccines Diphtheria – containing vaccines for children under 10 years Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenza type B vaccine ‘Pediacel’® Diphtheria low dose, tetanus, acellular pertussis and inactivated poliomyelitis vaccine ‘Repevax’® Diphtheria – containing vaccines for children over 10 years and adults Diphtheria low dose, tetanus and inactivated poliomyelitis vaccine ‘Revaxis’® Occupational Health only Diphtheria low dose, tetanus, acellular pertussis and inactivated poliomyelitis vaccine ‘Boostrix-IPV’® Haemophilus type b conjugate vaccine Haemophilus influenzae type B and Neisseria meningitidis group C ‘Menitorix’® Diptheria – containing vaccines for immunisation of pregnant women against pertussis Diphtheria low dose, tetanus, acellular pertussis and inactivated poliomyelitis vaccine ‘Repevax’® Hepatitis A vaccine Junior 0.5ml syringe available by Hepatitis A vaccine special order Hepatitis A and hepatitis B vaccine Hepatitis A + B vaccine ‘Twinrix’ Hepatitis B vaccine Nephrologists only Hepatitis B vaccine 40mcg/ml Influenza vaccine Under 5 years Inactivated Influenza vaccine Over 5 years Inactivated Influenza vaccine Inactivated Influenza vaccine (Low Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 134 - ovalbumin) Measles Mumps and Rubella (MMR) vaccine Measles, Mumps and Rubella vaccine (MMR) (Live) Meningococcal vaccines Meningococcal C conjugate vaccine Meningococcal A, C, W135 and Y conjugate vaccine ‘ Nimenrix’® Pneumococcal vaccines Pneumococcal vaccine Pneumococcal polysaccharide conjugate vaccine (adsorbed) ‘Prevenar’13® Rotavirus vaccine Live attenuated oral rotavirus vaccine Typhoid vaccines Polysaccharide typhoid vaccine Varicella – zoster vaccine Varicella – Zoster vaccine ‘Varilrix’® Varicella-Zoster vaccine ‘Zostavax’® Yellow fever vaccines Yellow Fever (Live) For childhood Immunisation programme only Occupational Health only. Microbiology advice required if prescribed by other specialties 70-80 years only For prevention of varicella infection (chickenpox) For prevention of herpes zoster (shingles) Occupational Health only Epsom Hospital is a designated holding centre 14.5 IMMUNOGLOBULINS Blood Product - Patient and product details required for tracking purposes 14.5.1 Normal immunoglobulin - See Trust and DoH clinical guidelines for immunoglobulin For subcutaneous use (PbR exclusion, Hospital only) Immunologists only Normal Immunoglobulin 1g/6ml, 2g/12ml, 4g/24ml, 8g/48ml ‘Gammanorm’® Immunologists only Normal Immunoglobulin 750 mg/5 ml, 1500 mg/10 ml ‘Subgam’® Immunologists only Normal Immunoglobulin 800 mg/5 ml, 1600 mg/10 ml ‘Subcuvia’® Immunologists only Normal Immunoglobulin 1g/5ml, 2g/10ml, 3g/15ml ‘Hizentra’® For intravenous use (PbR exclusion, Hospital only) No new patients Normal Immunoglobulin 2.5g, 5g & 10g ‘Vigam’® 5% Immunologists only Normal Immunoglobulin 0.5g, 2.5g, 5g & 10g ‘Flebogammadif’® 5% No new patients Normal immunoglobulin 5g and 10g ‘Intratect®’ 5% No new patients Normal Immunoglobulin 5g and 10g ‘Gammaplex’® 5% Normal Immunoglobulin 5g ,10g and Immunologists only 20g ‘Gamunex’® 10% Immunologists only Normal Immunoglobulin 5g and 10g ‘Kiovig’® 10% Trust brand of choice Normal Immunoglobulin 5g and 10g ‘Octagam’® 10% Trust brand of choice Normal Immunoglobulin 2.5g, 5g, Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 135 - 10g and 20g ‘Privigen’® 10% 14.5.2 Disease - specific immunoglobulin Tetanus Manufactured by BPL Tetanus Immunoglobulin Manufactured by Baxter Tetanus Immunoglobulin Unlicensed medicine Hospital only Varicella – zoster immunoglobulin Microbiology advice only Varicella-Zoster immunoglobulin Obtain direct from microbiology Named patient supply only Unlicensed medicine, hospital only 14.5.3 Anti-D (Rho) immunoglobulin Use in accordance with NICE Anti-D (Rho) immunoglobulin guidance in pregnancy for rhesus negative women (Aug 2008) Obtain direct from Haematology Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 136 - NICE technology appraisal 156 BNF SECTION 15 15.1 15.2 ANAESTHESIA General anaesthesia Local anaesthesia 15.1 GENERAL ANAESTHESIA 15.1.1 Intravenous anaesthetics Drugs used for intravenous anaesthesia Etomidate Hospital only Ketamine CD Extemporaneous product Ketamine oral solution CD Unlicensed medicine Hospital only Propofol Thiopental (thiopentone) 15.1.2 Inhalational anaesthetics Volatile liquid anaesthetics Isoflurane Sevoflurane Nitrous oxide MHRA Drug safety update Nitrous oxide: neurological and haematological toxic effects, especially with prolonged use (Dec 2008) Nitrous oxide 15.1.3 Antimuscarinic drugs Atropine Glycopyrronium Glycopyrronium tablets Glycopyrronium with neostigmine See section 15.1.6 Hyoscine butylbromide Hyoscine hydrobromide Unlicensed indication Hospital only Palliative care 15.1.4 Sedative and analgesic peri-operative drugs 15.1.4.1 Benzodiazepines Diazepam Lorazepam Midazolam CD Temazepam CD Phenothiazines and Related Alimemazine (trimeprazine tartrate) Chlorpromazine 15.1.4.2 Non-opioid analgesics Ketorolac trometamol Parecoxib Drugs and Driving Law March 2015 Drugs and Driving Law March 2015 ESTH guidelines for Midazolam for conscious sedation- Nov 2009 Drugs and Driving Law March 2015 MHRA Drug safety update Ketoprofen and ketorolac: gastrointestinal risk (Oct 2007) Anaesthetists only when other IV NSAIDs cannot be used Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 137 - 15.1.4.3 Opioid analgesics Alfentanil CD Fentanyl CD (see section 4.7.2) Remifentanil CD 15.1.4.4 Other drugs for sedation Dexmedetomidine 5mg/ml for intensive care areas only Anaesthetists only Anaesthetists only 15.1.5 Neuromuscular blocking drugs Non-depolarising neuromuscular blocking drugs Atracurium Mivacurium Consultant Neonatologists and Pancuronium Paediatricians only in accordance with the Neonatal transfer guidelines Rocuronium Vecuronium Product discontinued- supplies expected to cease Summer 2016 Depolarising neuromuscular blocking drugs Suxamethonium 15.1.6 Drugs for reversal of neuromuscular blockade Anticholinesterases Unlicensed medicine Edrophonium chloride Neostigmine Neostigmine with glycopyrronium Other drugs for reversal of neuromuscular blockade Consultant anaesthetists only for the Sugammadex sodium emergency reversal of rocuronium. 15.1.7 Antagonists for central and respiratory depression Doxapram (see section 3.5.1) Flumazenil Naloxone 15.1.8 Drugs for malignant hyperthermia Dantrolene sodium 15.2 LOCAL ANAESTHESIA Intralipid Intralipid 20% Articaine Articaine 4%/adrenaline (epinephrine) 1:100,000 ‘Septanest’ Lidocaine Lidocaine (lignocaine) 0.5% 1%, 2% Available for management of severe local anaesthetic toxicity Maxillofacial and Oral Surgeons only Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 138 - Patient safety alert Risk of distress and death from inappropriate doses of naloxone in patients on long-term opioid or opiate treatment (Nov 2014, Oct 2015) MHRA Drug safety update Intravenous dantrolene: risk of skin and injection site reactions from undissolved crystals—use a filter needle when drawing up reconstituted dantrolene solution and remain vigilant (July 2014) Lidocaine (lignocaine) 1% Lidocaine (lignocaine) 1% with adrenaline (epinephrine) 1 in 200,000 Lidocaine (lignocaine) 2% with adrenaline (epinephrine) 1 in 200,000 Lidocaine (lignocaine) 2% with adrenaline (epinephrine) 1 in 200,000 isotonic injection Lidocaine (lignocaine) 2% with adrenaline (epinephrine) in 80,000 cartridges Lidocaine (lignocaine) 5% with phenylephrine 0.5% Bupivacaine Bupivacaine 0.25% and 0.5% Bupivacaine in glucose ‘Marcain Heavy’ Bupivacaine 0.1% + fentanyl 2mcg/ml – 20ml pre-filled syringe CD Bupivacaine 0.1% + fentanyl 5mcg/ml – 250ml bag CD Levobupivacaine Levobupivacaine 0.25% Levobupivacaine 0.5% Levobupivacaine 0.75% Prilocaine Prilocaine 1% Prilocaine 3% with felypressin 0.03 units/ml Mepivacaine Mepivacaine 3% Ropivacaine Ropivacaine For Surface Anaesthesia Lidocaine Lidocaine 5% ointment Lidocaine 4% solution Lidocaine 10% spray Lidocaine 2% and chlorhexidine gluconate 0.25% ‘Instillagel’ Lidocaine 2.5% and prilocaine 2.5% Lidocaine (lignocaine) 4% with adrenaline (epinephrine) 0.1% and tetracaine 0.5% ‘LAT’® gel Lidocaine 5% plasters ‘Versatis’ ® For epidurals Ophthalmologists only For nose and oropharyngeal use only For fascia illaca blocks only Chiropody/podiatry only Ophthalmology only for peribulbar blocks Chiropody/podiatry only For use in EOC only Unlicensed medicine Hospital only Obtain via purchasing and logistics nd 2 line for patients allergic to ‘Ametop’® Paediatric A&E only, in accordance with Trust protocol Extemporaneous product Unlicensed medicine Hospital only Pain Team only, for post-herpetic neuralgia and localised neuropathic pain when all other treatments are ineffective or not tolerated. First month’s supply from the Trust then review by the Pain Team for efficacy, if further treatment required Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 139 - GP to be notified. Tetracaine Tetracaine (amethocaine) 4% ‘Ametop’ Other Ethyl chloride spray To test onset of regional anaesthesia and as local anaesthetic for minor skin procedures Epsom and St Helier University Hospitals NHS Trust Formulary Updated October 2016 - 140 -
