Drug Application Process & BCHCFT Formulary

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1 Drug Application Process & BCHCFT Formulary Version 1.0 If this is a paper copy of the document, please ensure that it is the most recent version. The most recent version is available on the Intranet/internet Page 1 of 21

2 Commencement of Consultation Date: November 2015 Consultation History: The following Committees, groups or individuals have been consulted in the development of this version of this Formulary: Name: Date: David Harris (Chief Pharmacist) November 2015 Johanne Deeks (Learning Disabilities Pharmacist) December 2015 Melanie Dowden (Lead Pharmacist Community Health) January 2016 Sudha Balakrishnan (Rehabilitation Consultant) January 2016 Karen Mitchell-Meades (Head Pharmacist Moseley Hall Hospital) January 2016 Carol Eadie (Head Pharmacist West Heath Hospital) January 2016 Neal McCathie (Consultant Community Paediatrician) February/May 2016 Dr Falope (Rehabilitation Consultant) February 2016 Dr Chit Ko Ko (Consultant Physician in Rehabilitation Medicine) February 2016 Rebecca Martin (Service Lead Tissue Viability) March 2016 Andrea Richards (Consultant Oral Physician) April 2016 Harriet Anstey (Consultant Oral Surgeon) April 2016 Olayinka.M.Fadahunsi-Oluwole (Speciality Doctor Community April 2016 Paediatrics) Medicines Management Committee March, April, May, June, July 2016 Previous Version History Version No. Lead Date Change Implemented Reason for Change NA New for BCHCFT This replaces consolidated Formulary (2014) and Community Hospitals Formulary (2012) Consultation Process Lead Clinicians are an integral part of the formulary development process and will provide expert clinical advice and support when a new drug formulary application is made. This information will be submitted to the Medicines Management Committee (MMC) in the first instance for first approval. Relevant Divisional Committees Proposed drugs to be considered for addition to BCHCFT formulary may be consulted at divisional committees before bringing to MMC for consideration. Area Prescribing Committee (APC) For medicines that BCHCFT services prescribe on FP10 or would like GPs to prescribe require final consultation and approval at the APC. Medicines must be approved by Medicines Management Committee prior to taking to the APC for consideration. Page 2 of 21

3 Section Page 1. Purpose 4 2. Scope 4 3. Responsibilities of Clinicians 4 4. Drug Application Process & BCHCFT Formulary 4.1 Formulary Revision Process 4.2 New Drug Application Process 4.3 BCHCFT Formulary References/Evidence/Glossary/Definitions 12 Appendices 1. Example of an APC Drug Application Form 13 Page 3 of 21

4 1. Purpose The aim of the formulary is to encourage safe, rational and cost-effective prescribing, and to have a unified choice of treatment for patients. It will ensure seamless transition of care for patients between Birmingham Community Healthcare Foundation Trust (BCHCFT) and General Practice. It is a locally maintained document and it also sets out the process to be followed when requests are made for a medicine to be added to the formulary. 2. Scope This formulary will apply across the whole of BCHCFT within all divisions. 3. Responsibilities of Prescribers All prescribers are expected to take into account whether the medicine they intend to prescribe is on the formulary. BCHCFT prescribers should consult the Area Prescribing Committee Formulary and BCHCFT Formulary. 4. Drug Application Process & BCHCFT Formulary 4.1 Formulary Revision Process Drugs on the current BCHCFT formulary do not need to go through the drug application process. If there is any change to the way a drug is prescribed this would then need to go through the application process outlined below (4.2). The BCHCFT Formulary and the Drugs List (page7) should be reviewed at least every two years. A representative from each division should be present at Medicines Management Committee to review the drugs for their specialist area. If there are any significant changes, the appropriate information and evidence to support this will be required and bought to committee using the documentation in Appendix New Drug Application Process The following algorithm sets out how new drugs will be considered for addition to the formulary for use within BCHCFT and for prescribing in primary care by GPs. Applications for the inclusion of a medication to the BCHCFT Formulary must be initiated by a consultant or other appropriate senior healthcare professional. Requests for products to be added to the formulary require approval from the Medicines Management Committee (MMC) followed by the APC approval process. If relevant a new drug application can be discussed at a divisional committee (e.g. Dental Drugs and Therapeutics Committee) prior to consultation at MMC. Medicines Page 4 of 21

5 for use within BCHCFT services only are not required to go through the APC application process. Flow chart showing BCHCFT & APC Drug Application Process Complete Formulary Application (See APC*) Medicines Management Committee Not Approved Approved for BCHCFT use * Application form to be obtained from cmcsu.medicinesmanagement@nhs.net See Appendix 1 as an example Is APC approval required? (i.e. Do GPs want to prescribe this drug or is it for BCHC prescribing only?) ** Complete ESCA or RICAD if necessary. APC can provide more information - see APC website No Add to BCHCFT approved list of medicines Yes APC** APC: Area Prescribing Committee RICAD: Rationales for Initiation, Continuation and Discontinuation ESCA: Effective Shared Care Agreement Not Approved Approve 4.3 BCHCFT Formulary Birmingham Community Healthcare Foundation Trust is a community trust providing treatment to patients in community settings, hospitals and specialist care. In the majority of cases, drug treatments will have already been initiated by the patient s GP or by another trust and if appropriate BCHCFT will continue. The BCHCFT Formulary comprises of two elements: (i) the Birmingham, Sandwell, Solihull and environs Joint Formulary otherwise referred to as the Area Prescribing Committee (APC) Formulary (ii) specified drugs in List A and B (page 7 to 12). The APC Formulary represents the drugs that Trusts and Clinical Commissioning Groups across the region have jointly agreed to prescribe in preference to other treatment options. It is expected the majority of prescribing will follow the APC formulary but this does not restrict a trust to prescribe or administer other such drugs where this is clinically indicated. The APC Formulary can be accessed here: Page 5 of 21

6 Any prescriber who wishes to use a product outside of formulary should either make a formal application for it to be considered at APC or request an individual funding request (IFR) to the commissioner. Prescribers should note that if a non-formulary medicine is commenced without the necessary approval, the Trust could be charged the ongoing costs. All drugs included in the APC Formulary are allocated a traffic light status. The red amber green ratings offer guidance on where clinical and prescribing responsibilities lie in regard to the initiation and maintenance of prescribing. Key to APC Formulary Recommendations Initiation and maintenance of prescribing by Specialists, GPs and other qualified clinicians Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing when appropriate, or initiation and maintenance of prescribing in Primary Care following recommendation from a Specialist. Some amber medicines require agreement with the local (internal) medicines committee prior to initiation; others may require a framework to support safe transfer and maintenance of care such as a RICaD or ESCA. The Formulary will be annotated to reflect these requirements. Initiation and maintenance of prescribing by BCHCFT Specialists only. Positive NICE TA; awaiting local clarification on place in therapy. Non Formulary; may be prescribed following approval by individual hospital Medicines Management Committees for specific patients. (The term 'Specialist' refers to Consultants, Non-Medical Prescribers and General Practitioners with a Specialist Interest) Medicines listed in the tables below are for use within this Trust only so that prescribing or administration remains with BCHCFT clinicians. There are two lists of medicines: List A: Medicines not on the APC formulary but approved for prescribing or administration within BCHCFT e.g. anaesthetics, unlicensed medicines. These medicines cannot be prescribed by GPs unless approved by the APC. List B: Medicines currently part of the APC formulary but used within BCHCFT for an unlicensed indication or off-label e.g. beclometasone inhaler for oral ulcerative conditions; erythromycin as a prokinetic agent. Some unusual forms of administration may require an APC application if Specialists would like GPs to prescribe. Prescribing may be declined by a GP on the grounds they are not sufficiently familiar with the drug treatment to accept clinical responsibility for agents that are used off label or are unlicensed. Page 6 of 21

7 Note: These drug lists are correct at the time of writing. Please cross reference with the APC formulary for the most up to date information. List A: Medicines not in the APC Formulary approved for use in BCHCFT Name of drug approved in BCHCFT formulary Service Area Indication/Notes Adrenaline injection Adults, Dental Acute anaphylaxis Articaine Dental Anaesthetic Atracurium injection Dental Neuromuscular blockade Atropine injection Adults, Dental Premedication; Intra-operative bradycardia; Control of muscarinic side-effects of neostigmine in reversing neuromuscular blockade AS Saliva Orthana Dental Xerostomia, Sicca Syndrome/ Sjogren s Syndrome, following Radiotherapy Benzocaine 20% gel (Ultracare Oral Dental Topical anaesthesia Bubble Gum ) Baclofen liquid (some strengths) Adults, Rehab Skeletal muscle relaxant BioXtra Gel and Mouthrinse Dental Xerostomia, Sicca Syndrome/ Sjogren s Syndrome, following Radiotherapy Botulinum toxin B Adults, Rehab, Dental Spasmodic torticollis; masseteric hypertrophy Budesonide nasal spray Dental Oral ulcerative conditions Bupivacaine 0.5% Adults, Rehab, Anaesthetic Dental Calcium chloride injection Adults Hyperkalaemia, hypocalcaemia Carnoy s solution (ethanol, Dental Odontogenic keratocyst chloroform, glacial acetic acid) Chloracetic acid crystals in solution Adults Treatment of hard corns and verrucae Chlorhexidine gluconate 2.5 mg Dental Antimicrobial treatment for (Periochip) chronic periodontal disease Chlorhexidine gluconate surgical Dental Surgical scrub scrub (Hydrex) Chlorhexidine sachets (Unisept) Dental Skin disinfection Chlorhexidine 2% in Isopropyl Dental Skin disinfection Alcohol 70% (ChloraPrep) Co-codamol 8/500 Adults, Rehab, Analgesic Dental Dantrolene injection Dental Malignant hyperthermia Dehydated alcohol Dental Trigeminal neuralgia Page 7 of 21

8 Diphtheria tetanus pertussis Adults Immunisation (acellular) and hib vaccine Dopamine Dental Inotropic agent Dobutamine solution for infusion Dental Inotropic agent Dosulepin LD, Dental For Dental - facial pain: Antidepressant Ephedrine injection Dental Sympathomimetic Esomeprazole injection Adults Gastroesophageal disease Ethyl chloride spray Dental Topical anaesthetic; vitality testing Ferric subsulphate 70% solution Dental Topical haemostatic agent (Monsel s solution) Flumazenil Dental, Rehab Conscious sedation Gaviscon Advance Adults Gastrointestinal symptoms Gelofusine infusion Dental Plasma substitute Glandosane spray Dental Xerostomia, Sicca Syndrome/ Sjogren s Syndrome, following Radiotherapy Glucose infusion Dental Hypoglycaemia Glycopyrrolate Rehab Hypersalivation Guanfacine hydrochloride (Intuniv) Children ADHD in children Hepatitis B vaccine Adults Immunisation against hepatitis B Human Papillomavirus vaccine Children Prevention of cervical cancer and premalignant cervical lesions Hydrocortisone /Chlorhexidine Dental Oral ulcerative conditions /nystatin (Nystaform HC) Influenza vaccine (inactivated and Adults/Children Prevention of seasonal flu live intranasal) Intralipid Dental Reversal of local anaesthetic overdose Isoflurane Dental Anaesthesia Ketorolac injection Dental Post operative pain Levobupivacaine Rehab Anaesthesia Lidocaine injection Rehab Anaesthesia Lidocaine 2% in ethyl chloride Adults Anaesthesia Lidocaine 5% ointment Dental Anaesthesia Lidocaine + chlorhexidine Adults Catheterisation (Instillagel) Lidocaine +/- adrenaline Dental, Rehab Anaesthesia Lidocaine+prilocaine (Oraqix, Emla) Dental Local anaesthetic Magnesium sulphate paste Rehab Superficial skin infections Medical gases (e.g. oxygen, nitrous Adults, Dental Treatment of hypoxaemia; oxide) anaesthesia Measles Mumps Rubella vaccine Children Prevention against measles, mumps, rubella Page 8 of 21

9 Mepivacaine 3% Adults, Dental Anaesthesia Meningococcal ACWY (MenACWY) Adults Vaccination against meningococcal disease Midazolam1mg/1ml injection, intranasal (+ lidocaine) Dental, Rehab Premedication/ conscious sedation Midazolam 10mg/ml buccal LD, Dental Seizures Minocycline 2% periodontal gel (Dentomycin) Dental Chronic adult periodontitis Neostigmine injection Dental Reversal of neuromuscular blockade Neostigmine/glycopyrronium Dental Reversal of neuromuscular blockade Nitrous oxide Dental Anaesthesia; sedation Noradrenaline injection Dental Acute hypotension Nortriptyline Dental, Rehab Neuropathic pain Omnipaque (Iohexol) Dental Diagnostic agent Pentoxifylline Dental Recurrent Aphthous Stomatitis; Osteoradionecrosis Phenol Aqueous 6%injection Rehab Nerve ablation Phenol in Glycerol 5% injection Rehab Intrathecal for spasticity Phenol liquid Adults Ablation of the nail bed PEP (Kaletra, Truvada, raltegravir) Dental Prevention of HIV needle stick injury Pneumococcal polysaccharide vaccine Adults Immunisation against disease caused by Streptococcus pneumoniae Skin disinfection Povidone Iodine 7.5% surgical Dental scrub/ Prilocaine Dental Anaesthesia Prilocaine Hydrochloride with Dental Anaesthesia Felypressin (Citanest) Propofol Dental Anaesthesia; sedation Pyrogallol 40% in WSP Adults Treatment of neurovascular corns Rocuronium injection Dental Neuromuscular blockade Salicylic acid 60% in WSP Adults Treatment of hard corns and verrucae Saliva Stimulating Tablets (SST) Dental Xerostomia, Sicca Syndrome/ Sjogren s Syndrome, following Radiotherapy Sativex spray Rehab Refractory spasticity in patients with MS Sevoflurane Dental Anaesthesia Shingles vaccine (Zostavax) Adults Immunisation against shingles Sodium bicarbonate injection Adults Metabolic acidosis Sodium chloride mouthwash Dental Mucosal ulceration & inflammation Page 9 of 21

10 Sodium chloride infusion/injection Dental Fluid replacement/flush Sodium lactate infusion Dental Hyperchloraemic acidosis (Hartmanns) Sodium fluoride varnish/ tablet Dental Prevention of dental caries Sugammadex (Bridion) Dental Reversal of neuromuscular blockade Suxamethonium injection Dental Neuromuscular blockade Sterile glycerin Adults Neutralisation of phenol Tetracaine gel (Ametop) Dental Local anaesthesia Tetrafluoroethane spray Dental Production of topical cryoanaesthesia in the oral cavity Thiopental Dental Anaesthesia Tiagabine LD Seizures Tranexamic acid injection/oral Dental Fibrinolysis during dental solution procedures; mouthwash Xerotin spray Dental Xerostomia, Sicca Syndrome/ Sjogren s Syndrome, following Radiotherapy Zuclopenthixol acetate (Acuphase) injection LD Psychoses List B: Medicines in the APC Formulary used for an unlicensed indication/offlabel approved for use in BCHCFT Name of drug approved in BCHCFT formulary Service Area Indication/Notes Amantadine Rehab Neurostimulant Amitriptyline Dental Facial pain Atropine eye drops Rehab Hypersalivation Azathioprine Dental Severe ulcerative conditions Beclometasone dipropionate inhaler Dental Mucosal ulceration and (Clenil Modulite) inflammation Beclometasone dipropionate nasal Dental Oral ulcerative conditions spray Betamethasone tablet Dental Oral inflammation and ulceration (used as a mouthwash) Betamethasone valerate cream and Dental Oral ulcerative conditions ointment (Betnovate) Bromocriptine Rehab Neurostimulant in prolonged disorder of consciousness minimally conscious state; Treatment of apathy symptoms after brain injury Carbamezepine Dental, Children Facial pain; mood stabiliser Page 10 of 21

11 Citalopram Children Panic and anxiety Clindamycin capsule Dental Severe bone infections; antibiotic prophylaxis in oncology patients Clobetasone butyrate cream and Dental Oral ulcerative conditions ointment (Eumovate) Clobetasone Dental Oral ulcerative conditions butyrate/nystatin/oxytetracycline (Trimovate) Colchicine Dental Oral ulceration and inflammation Clobetosol propionate cream and Dental Oral ulcerative conditions ointment (Dermovate) Clonidine Children ADHD and Tourettes Co-careldopa Rehab Neurostimulant Cyclizine Dental Nausea/vomiting Dapsone Dental Vesiculobullous disorders, Lichen Planus, Linear IgA disease Dexamethasone injection Dental Anti-inflammatory agent Doxycycline Dental Aphthous ulcers Erythromycin suspension Rehab Prokinetic agent Fluoxetine Dental Facial pain Fluticasone propionate spray/nasules Dental Oral ulcerative conditions Gelclair Dental Relieve the pain of oral mucositis Hyoscine patch Children Drying secretions Hydroxochloroquine Dental Oral mucosal inflammatory conditions (Chronic ulcerative stomatitis; Oral Lichen Planus) Hydrocortisone cream with Dental Oral ulcerative conditions miconazole (Daktacort) Lamotrigine Dental Facial pain Melatonin (note some products/strengths are unlicensed e.g. Kidnap) Methylphenidate (including Matoride) Midazolam Oromucosal Solution Rehab, Children LD, Children LD Sleep problems in brain injury; sleep problems in children ADHD in adults and children Seizures in adults (Buccolam) Mycophenolate Dental Lichen Planus, Pemphigus, Pemphigoid, Orofacial granulomatosis under specialist supervision Ondansetron injection Dental Prevention nausea/vomiting Oxcarbazepine Dental Treatment of trigeminal/ glossopharyngeal neuralgia Page 11 of 21

Original Date of issue: 01/11/2005 Last Reviewed: 01/05/2011 Version:4 Page 1 of 7

Original Date of issue: 01/11/2005 Last eviewed: 01/05/2011 Version:4 Page 1 of 7 15: Anaesthesia 15.1 General anaesthesia 15.1.1 Intravenous anaesthesia Etomidate Injection (20mg/10ml) Ketamine Injection