Prescribing Information for Solihull Prescribers August 2015 v1 Page 1 of 21 pages Approved by: Medicines and Prescribing subcommittee September 2015 Review: August 2017

Prescribing Information

for

Solihull Prescribers

Updated August 2015 v1 Prepared by Fiona Beadle, Prescribing Support Pharmacist on behalf of the Medicines & Prescribing Team, Solihull CCG

Contact: fiona.beadle@nhs.net

Medicines & Prescribing website on Solihull CCG intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing APC Formulary: http://www.birminghamandsurroundsformulary.nhs.uk/

The information contained in this document is based on evidence available at the time of writing. It is intended for use within the NHS and may not be used outside the NHS without written permission. It is issued for guidance & advice only, and does not override the individual responsibility of healthcare

professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summaries of product characteristics of

any drugs. Prescribers remain responsible for their patients’ care and prescriptions signed.

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Contents

Topic Page

General information 2 Key prescribing issues (BNF order) 8

Formulary access 19

Website - Medicines & Prescribing 19 Newsletters 20

Prescribing data 20 Useful weblinks 21

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GENERAL INFORMATION The information contained in this document is issued for guidance & advice only, and does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summaries of product characteristics of any drugs. Prescribers remain responsible for their patients’ care and prescriptions signed. Practices have a responsibility to ensure good quality and cost-effective prescribing. Prescribing Support Pharmacists (PSPs) and Prescribing Support Technicians work with practices to help with prescribing issues, answer clinical queries and help monitor prescribing via audits and reviews. Throughout the year, the PSP will help identify areas for review, either to improve safety and clinical care, or help to keep the prescribing budget on target. This helps demonstrate that the practice is actively engaged in clinical governance and provision of high quality care; and can also be used as evidence for the local contract, CQC and GP appraisals.

Medicines & Prescribing intranet site (also see page 19) The Medicines & Prescribing website can be accessed via the Solihull CCG intranet home page by clicking on Medicines & Prescribing in the ‘Members’ section or via this link: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing

Area Prescribing Committee (APC) and Formulary An APC covering Birmingham, Solihull, Sandwell, and South Staffs & Seisdon CCGs, and the provider Trusts in this geographical area consider all medicines which may be prescribed in primary care (either practice or Trust initiated), and all medicines which the CCGs will be responsible for funding for use in the Trusts. Medicines approved for inclusion in the Formulary will be traffic lighted as follows:

Green: Suitable for initiation and maintenance by all prescribers (with the competencies to practice in that clinical area). Medicines may be designated as first tier or second tier within the green category.

Amber: Specialist initiation (initial prescribing by the consultant) and then suitable for transfer to GP prescribing, or drugs recommended by a specialist for primary care prescribing and initiation. Some amber medicines are recommended to have a framework to support safe transfer and maintenance of care, e.g. Effective Shared Care Agreement (ESCA) or Rationale for Initiation, Continuation and Discontinuation (RICaD). The APC formulary will highlight medicines covered by an ESCA or RICaD and include a link to the relevant ESCA or RICaD

Red: Initiation and maintenance prescribing by specialist

Black: Non-formulary - medicines considered for inclusion but declined.

Harmonising the three major Formularies previously in place across the APC geographical area is still in progress. . Completed harmonised chapters and new products approved for formulary inclusion will be published in the web-based APC Formulary which can be accessed via this link: http://www.birminghamandsurroundsformulary.nhs.uk/. Medicines subject to a positive NICE TA will also be added to the Formulary at the first APC meeting following publication.

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Medicines in chapters which have not yet been harmonised will all appear as non-formulary in the APC Formulary until the harmonisation process has been completed. Please check the Interface Formulary or ask your PSP for advice if the chapter has not yet been harmonised. The Interface Formulary can be accessed via this link: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing and searched using <Ctrl F>. Prescribing is expected to follow formulary recommendations where possible. Non-formulary prescribing should only occur in exceptional circumstances e.g. patient moved from another area & stable on a drug not in formulary. For further information please speak to your PSP. The practice clinical system has an inbuilt practice default formulary, which can be set up to reflect the formulary options. Practice formularies help identify formulary options when medicines are being selected for prescribing. Please speak to your practice manager or PSP if you need further information.

BNF The BNF is distributed as a paper version once a year, in September, but is updated electronically every month. To ensure that you only access the latest information please access the BNF and BNF-C via the web https://www.medicinescomplete.com/mc/bnf/current/ or via an app for mobile devices http://www.nice.org.uk/About/What-we-do/NICE-apps-for-smartphones-and-tablets

ScriptSwitch ScriptSwitch is a prescribing decision support tool linked to the GP clinical system. It offers information messages (safety, guidance, medicine shortages etc) and options for cost-effective therapeutic switching when a prescription is first generated or re-authorised. Please accept ScriptSwitch recommendations wherever possible to realise the potential savings. The ScriptSwitch system does not access the patient’s clinical notes, therefore the prescriber needs to consider the suitability of the switch for that individual patient. The decision on whether or not to accept a switch remains with the prescriber, who retains clinical responsibility for the prescription. ScriptSwitch content is driven locally via the CCG. Please leave feedback on switches and messages, using

the feedback button located in the bottom left-hand corner of the switch pop-up. Alternatively, please e-mail any suggestions or comments about ScriptSwitch to the mailbox at scriptswitch.medicines@nhs.net If ScriptSwitch has stopped working or you have new computers installed, please contact ScriptSwitch support on: 02476 214700 or support@scriptswitch.com

Prescribing requests from secondary care Please check the Formulary before prescribing any drug recommended by secondary care. Some drugs should only be prescribed by secondary care or are commissioned via the Specialist Commissioning Team. Others may be appropriate for prescribing within primary care, following initiation in secondary care, using an ESCA or RICaD (linked from individual monographs in APC Formulary). GPs are encouraged to use the APC Decline to Prescribe Form to let a hospital specialist know why they are unable to assume responsibility for prescribing an item (e.g. non-formulary, unlicensed, requires an ESCA or RICaD). The form has been embedded in some GP systems or can be accessed via: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/non-clinical-guidance-resources . It is also on Map of Medicine.

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Specialist Commissioning Commissioning of specialised, low volume, high cost services is undertaken by the specialist commissioning function of NHS England, and are set out in the Manual. Medicines associated with these services are normally provided by the provider trust. Responsibility for commissioning (and therefore funding) high cost drugs is set out here, as well as in the Formulary. Prescribing of post-transplant immunosuppressants and of inhaled therapies for cystic fibrosis falls under the remit of Specialised Services and is being transferred back from primary care to the specialist teams. Practices should continue to prescribe for patients who were receiving these medicines from their GP prior to April 2013, but should not be asked to take over prescribing for any new patients. Please return any such requests to the specialist centre using the Decline to Prescribe form.

Prescribing following a private referral Patients who request a private referral should be advised that if the referral leads to recommendation by the specialist for a drug not in the formulary, this will not necessarily lead to an NHS prescription. The GP may prescribe an equivalent drug which is on the formulary or the patient has the option of purchasing the prescribed drug via a private prescription from the private specialist.

Some practices are adding the following message to the bottom of all referral letters (private and NHS): If patients choose to use the private health care sector, subsequent transfer back to NHS care (e.g. prescribing

via FP10) must meet the usual NHS commissioning arrangements, including being in line with the locally agreed Formulary and guidelines.

Following an NHS referral, all subsequent prescriptions must adhere to the locally agreed Formulary and guidelines.

Prescription quantities It is important to balance the patient perspective against the need to reduce drugs wastage. A 28 day supply may be appropriate for many patients. “However, where patients have stable long-term conditions, and can manage their stocks of medicines effectively, prescriptions for longer periods may be more suitable & convenient for patients.” (Medicines, Pharmacy & Industry Group, Department of Health). http://www.npc.nhs.uk/resources/connect_issue_55.pdf

Switching therapy due to inadequate response Please check compliance before increasing a dose or switching a patient’s medication due to apparent inadequate response. If there are compliance concerns, consider referral to a Community Pharmacist for a Medicines Use Review (MUR).

‘Specials’ – unlicensed non-standard oral preparations or topical mixtures Non-standard strengths of oral liquids and previously low cost mixtures of creams or ointments now have to be prepared by a ‘specials’ manufacturer. They are unlicensed and can be very expensive. Please prescribe licensed proprietary preparations wherever possible. Licensed oral liquids and creams will be listed in the BNF under the appropriate section. For children under the care of Birmingham Children’s Hospital, prescribing of unlicensed specials will be arranged by the hospital. For further details see resources on the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/non-clinical-guidance-resources/38-bsol-specials-project

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Unlicensed preparations Products without a product licence include gamolenic acid, ginkgo biloba, glucosamine, St John's Wort and melatonin. As not ‘black listed’, they can be prescribed on the NHS. However, the prescriber carries full clinical responsibility and many preparations are of variable quality, with no formal documentation of possible adverse effects or formal evidence of efficacy. Many of these preparations will interact with prescribed medication such as warfarin, with unpredictable effects. It is recommended that GPs do not prescribe these products.

Generic prescribing Prescribe generically for most situations, except for modified release preparations and other medications where differences in bioavailability may affect therapeutic efficacy. Certain drugs should always be prescribed by brand e.g. opioids, certain anticonvulsants, lithium, mesalazine, ciclosporin, tacrolimus, beclometasone cfc-free inhalers and modified release preparations of theophylline, nifedipine and diltiazem. Preparations with multiple ingredients e.g. combination inhalers, insulins, HRT, oral contraceptives and some dermatological preparations should be prescribed by brand to avoid confusion. For a few drugs, there is a large cost saving to be realised by prescribing by brand, so prescribers are encouraged to prescribe by brand in these situations, e.g. Beconase nasal spray, Sinemet Plus. ScriptSwitch will help identify these and recommend appropriate switching.

Prescribing for patients going abroad BMA guidance is that the NHS accepts responsibility for supplying medication for temporary periods abroad of up to 3 months. If going for more than 3 months, then all that the patient is entitled to at NHS expense is sufficient regular medication to get to the destination and find an alternative supply. “A patient is entitled under the NHS to drugs that the doctor believes are necessary, not what the patient feels should be prescribed. GPs are responsible for all prescribing decisions they make and for any consequent monitoring that is needed as a result of the prescription given.” See BMA website for further information. http://www.bma.org.uk/

Medicines waste It is estimated that the cost of unused prescription medicines in Solihull is around £750,000 each year. Most of this waste results from patients over-ordering medicines, or not letting a doctor or pharmacist know that they no longer need medicines. Once medicines have left the pharmacy they can't be reused, recycled or used by anyone else. In addition to the cost implications, there is a safety concern in that patients might inadvertently take medicines that have been stopped or are out of date. Please regularly review a patient’s repeat prescription record and remove items from repeat if they are no longer required regularly, to ensure that they are not inadvertently requested. Some practices are adding this message to all repeat prescriptions:

The estimated cost of unused medicines in Solihull is around £750,000 per year. This could have funded nearly 1,000 routine operations.

This surgery will no longer accept repeat prescriptions without a tick indicating which item is required. Please be responsible and only order what you need.

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Medicines Safety Patient Safety Incidents Any incident which is likely to have an immediate impact on patient safety should be addressed immediately, clinician to clinician i.e. if there is an issue with regard to discharge medication, the clinician identifying the incident should discuss this with the discharging physician. All incidents should then be reported to one of the following routes for follow up where appropriate: GP practice incidents via the eForm on: https://report.nrls.nhs.uk/GP_eForm Incidents relating to HEFT or Local Improvement Services (LISs): solihullccg.seriousincidents@nhs.net Incidents relating to the Mental Health Trust: solihullccg.seriousincidents@nhs.net Incidents relating to Community Pharmacy: england.medsreporting@nhs.net Incidents relating to privately funded care at Spire should be reported to the Head of Clinical Governance at Spire Adverse Drug Reactions (ADRs) Suspected Adverse Drug Reactions should be reported via the Yellow Card scheme: https://yellowcard.mhra.gov.uk/ High Risk Drugs Searches can be set up on the practice clinical system to check that patients prescribed high risk drugs (e.g. DMARDs), are being appropriately monitored. Please ask your PSP about this.

Map of Medicine Map of Medicine is a referral decision support tool linked to the GP clinical system. It offers local and national NICE guidance pathways, referral guidance including inclusion and exclusion criteria and referral forms which integrate with the patient record. The local information elements are managed by the CCG and will help keep GP practices up to date with any service changes or alterations to referral process. Please e-mail any suggestions or comments to Hannah.nurrish@nhs.net

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CURRENT KEY PRESCRIBING ISSUES This section highlights key issues only. Please refer to the APC Formulary on http://www.birminghamandsurroundsformulary.nhs.uk/ or the Interface Formulary on the Medicines & Prescribing intranet site http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing for further information on formulary status, need for shared care arrangements etc.

1. Gastrointestinal system Alginates - Peptac 1st line (aniseed or peppermint flavour). Gaviscon & Gaviscon Advance are non-formulary. PPI policy- 1st line – omeprazole or lansoprazole capsules. PPIs should be regularly reviewed and dose stepped down if possible. PPI use has been associated with an increased risk of C difficile. For patients with genuine swallowing difficulties, lansoprazole orodispersible tablets (Zoton FasTabs) are considerably less expensive than omeprazole dispersible tablets (Losec MUPS). Esomeprazole is not in the formulary. Laxatives – regularly review longterm stimulant laxatives. Laxido sugar-free is cheaper than Movicol or generic equivalent, for faecal impaction, chronic idiopathic constipation and opioid induced constipation, not controlled by 1st line treatments.

Domperidone – now restricted to relief of nausea and vomiting, at lowest effective dose for shortest possible time , due to risk of cardiac side effects (MHRA ) Haemorrhoid preparations – cost differences between preparations with the same, or similar, ingredients – follow ScriptSwitch recommendations for the most cost-effective preparation Anal fissure – 1st line: GTN ointment (Rectogesic). 2ndline: diltiazem cream (unlicensed) only for patients intolerant of or unresponsive to GTN ointment.

2. Cardiovascular system Eplerenone – only in line with NICE CG 108 and supported by a RICaD. http://www.birminghamandsurroundsformulary.nhs.uk/searchresults.asp?SearchVar=eplerenone Lipid modification Primary Prevention – Before drug treatment is initiated discuss lifestyle modification and optimise the management of other modifiable CVD risks, taking into account additional factors such as potential benefits from lifestyle modifications, informed patient preference, co-morbidities, general frailty and life expectancy Secondary Prevention – Offer lipid modification without delay. See table for options. If a patient is not able to tolerate a high intensity statin aim to treat with the maximum tolerated dose When a decision is made to use a statin prescribe a high intensity statin at low cost

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Summary of NICE Guidance on Lipid Modification (CG 181) and familial hypercholesterolaemia (CG71)

Indication Therapy

Primary Prevention of CVD (non-diabetic)

Offer atorvastatin 20mg to people who have a 10% or greater 10-year risk of developing CVD, estimated using QRISK2 assessment tool.

Primary Prevention of CVD (over 85 years old)

Consider atorvastatin 20mg, as statins may be of benefit in reducing the risk of non-fatal myocardial infarction. Be aware of factors that may make treatment inappropriate e.g. comorbidities, polypharmacy, general frailty and life expectancy.

Secondary Prevention Start statin treatment in people with CVD with atorvastatin 80mg. Use a lower dose of atorvastatin if any of the following apply: potential drug interactions, high risk of adverse effects, patient preference.

Primary Prevention Type 1 Diabetes

Consider statin treatment for the primary prevention of CVD in all adults with Type 1 diabetes. Offer statin treatment to adults with type 1 diabetes who:

are older than 40 years or

have had diabetes for more than 10 years or

have established nephropathy or

have other CVD risk factors. Start treatment with atorvastatin 20mg.

Primary Prevention Type 2 Diabetes

Offer atorvastatin 20mg for the primary prevention of CVD to people with

type 2 diabetes who have a 10% or greater 10‑year risk of developing CVD. Estimate the level of risk using the QRISK2 assessment tool.

People with CKD Offer atorvastatin 20 mg for the primary or secondary prevention of CVD to people with CKD

Increase the dose if a greater than 40% reduction in non‑HDL cholesterol is not achieved and eGFR is >30 ml/min/1.73 m2 or more.

Agree the use of higher doses with a renal specialist if eGFR <30 ml/min/1.73 m2

Familial hypercholesterolaemia

Statins should be the initial treatment for all adults with FH. Consider prescribing a high-intensity statin and increasing to maximum tolerated or licensed dose to achieve a recommended reduction in LDL-C concentration of greater than 50% from baseline. Ezetimibe monotherapy is an option for patients intolerant to statin therapy or where contraindicated. Ezetimibe, coadministered with initial statin therapy, is an option when serum total or LDL-C concentration is not appropriately controlled either after appropriate dose titration of initial statin therapy or because dose titration is limited by intolerance to the initial statin therapy and consideration is being given to changing to an alternative statin.

Rosuvastatin for specialist initiation only at lipid clinic.

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Hypertension

Summary of NICE Guidance on Hypertension: Clinical management of primary hypertension in adults (CG127)

Step < 55 >55 Black people of African/Caribbean family origin

1 ACEi or ARB CCB (or diuretic if a CCB is not suitable, e.g. example because of oedema or intolerance, or evidence of heart failure or high risk of heart failure)

CCB (or diuretic if a CCB is not suitable, e.g because of oedema or intolerance, or evidence of heart failure or high risk of heart failure)

2 Add CCB Add ACEi or ARB Add ARB (in preference to ACEi)

3 Review medication to ensure step 2 treatment is at optimal or best tolerated doses prior to adding a third agent

Add Diuretic Add Diuretic Add Diuretic

4 Resistant hypertension consider adding a fourth agent and/or seeking expert advice

Consider further diuretic therapy (low dose spironolactone) or if contraindicated/not tolerated consider and alpha- or beta-blocker.

ACEi = Angiotensin converting enzyme inhibitor. (Formulary choices: ramipril capsules,lisinopril and perindopril erbumine) ARB = Angiotensin receptor blockers. (Formulary choices: candesartan, irbesartan, losartan, valsartan) CCB = Calcium Channel blocker. (1

st choice amlodipine, felodipine as Cardioplen XL or Felotens XL)

Diuretic = Thiazide-like diuretic (e.g. indapamide 2.5mg (not m/r))

Doxazosin – only for 4th/5th line treatment. Doxazosin MR tabs are non-formulary. Anticoagulation Anticoagulants should only be initiated by clinicians/practitioners who have the necessary skills and experience in line with local commissioning arrangements. Following knee and hip surgery, full courses of anticoagulation should be prescribed by secondary care so GPs should not prescribe or be asked to prescribe. The choice of agents used for anticoagulation should be made in collaboration with the patient in line with NICE guidance. NICE Atrial Fibrillation Patient Decision Aids based on CHA2DS2-VASc and HASBLED scores can be found on the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/cardiovascular/af-patient-decision-aids A template is available on clinical systems in Solihull CCG to support prescribers to help patients with AF make an informed decision about treatment options. Warfarin – Follow practice protocol for monitoring & prescribing. Ensure INR results are known before prescribing. Yellow warfarin book should be seen before prescribing. Check that adequate monitoring is taking place and dosage instructions in the yellow book are adequate Newer Oral Anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban – where initiation of these drugs is not the patient’s GP, transfer to GP should be with the support of RICaD (see APC website) There are agent specific monitoring requirements for NOACs. Up to date renal function tests are required before commencing a NOAC; and apixaban also requires LFTs. Dosage will vary according to differing clinical factors. See BNF or the manufacturer’s SPC for the most accurate advice. There are also resources from the Birmingham, Sandwell & Solihull Cardiac & Stroke Network (BSSCSN) to support prescribers considering a NOAC for AF. These include: BSSCSN position statement, patient clinical discussion guide and checklist. http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/cardiovascular

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Enoxaparin – Formulary status: Green for single use in DVT and Red for all other indications until arrangements have been agreed to allow safe transfer of patient care. ESCAs are being developed. Aspirin – Prescribe dispersible tablets as no proven benefits to using enteric coated aspirin. Carefully assess balance of risks v benefits for the individual when considering use in primary prevention. Clopidogrel – Follow NICE and local guidelines. See table below. Treatment with clopidogrel should be with the least costly licensed preparation – NICE TA 210

No evidence/licence for clopidogrel for primary prevention or TIA, nor for clopidogrel + aspirin long-term, (although cardiologists may recommend this for complicated multiple stent patients). Antiplatelet therapy for stroke or TIA Diagnosis 1

st line 2

nd line 3

rd line

Ischaemic stroke Generic clopidogrel 75mg daily lifelong

Aspirin 75mg daily + dipyridamole MR 200mg twice daily lifelong if clopidogrel contraindicated or not tolerated

Dipyridamole MR 200mg twice daily lifelong if aspirin and clopidogrel contraindicated or not tolerated

TIA * Aspirin 75mg daily + dipyridamole MR 200mg twice daily lifelong

Aspirin 75mg daily lifelong if dipyridamole contraindicated or not tolerated

Dipyridamole MR 200mg twice daily lifelong if aspirin contraindicated or not tolerated

Other common indications for antiplatelet therapy Diagnosis 1

st line 2

nd line 3

rd line

Stable angina Aspirin 75mg daily Clopidogrel 75mg daily

Established peripheral vascular disease, multivascular disease

Clopidogrel 75mg daily Aspirin 75mg daily

Medically managed STEMI

Aspirin 75mg lifelong +

Clopidogrel 75mg daily for 28 days and consider for up to 12 months (NICE CG172)

Aspirin 75mg daily Clopidogrel 75mg daily

NSTEMI and unstable angina

Aspirin 75mg lifelong +

Clopidogrel 75mg daily for 12 months* or ticagrelor (within NICE as below)

Aspirin 75mg daily Clopidogrel 75mg daily

Acute Coronary Syndrome + PCI

Aspirin 75mg lifelong + either:

clopidogrel or prasugrel (within NICE TA 317) https://www.nice.org.uk/guidance/ta317 or

ticagrelor (within NICE TA 236) http://www.nice.org.uk/guidance/TA236

*From most recent event or as otherwise directed by cardiologist

Under certain circumstances cardiologists may recommend different treatment regimes Further information from the Intercollegiate Stroke Working Party (2012) can be found on: https://www.rcplondon.ac.uk/sites/default/files/national-clinical-guidelines-for-stroke-fourth-edition.pdf

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3. Respiratory system Inhaled corticosteroids (ICS) Prescribe by brand to avoid confusion. Check inhaler technique and concordance before changing therapy. Most ICS/LABA combination inhalers should last 1 month when used at recommended licensed dose. Recording number of ICS and bronchodilator inhalers ordered in previous 12 months will help highlight over or under ordering. Information about inhaler technique and demonstration videos can be accessed via this link: https://solihullccg.nhs.uk/yourhealth/inhalertechnique Asthma: Follow BTS/SIGN guidance for asthma and remember to step down inhalers/therapy as appropriate as well as stepping up. All patients should have asthma management plans. Details of placebo inhalers and self management plans are available on the intranet. http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/respiratory Combination ICS/LABA (adults) 1st line: Flutiform for new patients requiring ICS/LABA and for patients whose ICS/LABA therapy is being stepped up or down. COPD: Follow NICE GC 101 & local guidance for COPD Formulary choices for inhaled therapy in COPD: Long-acting muscarinic antagonists – aclidinium, glycopyrronium, ipratropium or tiotropium Long-acting beta agonist – formoterol or salmeterol Long-acting beta agonist/ICS – Symbicort 400/12, Seretide 500 Accuhaler or Fostair 100/6 COPD pathway and prescribing pathway (one page summary) and patient information on rescue medicines is available on the intranet http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/respiratory Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with ICS and be prepared to discuss this with patients: http://www.nice.org.uk/guidance/CG101 Allergic rhinitis – Non-sedating antihistamines – 1st line: cetirizine (tablets not capsules) or loratadine. 2nd line: fexofenadine. (NB: levocetirizine, desloratadine, acrivastine and mizolastine are non-formulary) Sodium chloride 7% nebules for cystic fibrosis – prescribe as Nebusal as cheaper than generic Adrenaline (epinephrine) auto-injector devices (e.g. EpiPen) for acute anaphylaxis People who have been prescribed an adrenaline auto-injector because of the risk of anaphylaxis should carry two with them at all times for emergency, on-the-spot use. The patient or carer needs to be taught how to use the device. Additional devices will not normally need to be prescribed unless the device has been used or expired. See MHRA Drug Safety Update for further information.

4. Central nervous system Antipsychotics – not routinely recommended for patients with dementia due to increased risk of cerebrovascular events (see NICE/Social Care Institute for Excellence). Risperidone is the only antipsychotic licensed for short term treatment of behavioural and psychiatric symptoms of dementia (BPSD). Patients on lithium need to have their hand held booklet updated at each visit.

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Antidepressants –1st line SSRI: sertraline, fluoxetine or citalopram. Sertraline has best evidence of safety in cardiovascular disease. Citalopram (and escitalopram – non-formulary) can prolong QT interval. Regularly review patients on antidepressants. Insomnia – sleep hygiene advice should always be given and may be sufficient (see Good Sleep Guide on intranet). If hypnotic indicated prescribe short course for maximum of 2 weeks. Currently zopiclone is a cheaper option than temazepam. Resources to support appropriate hypnotic use are available on intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/central-nervous-system Melatonin – Melatonin is RED in the APC formulary for secondary care prescribing only. Analgesics –consider paracetamol regularly +/- prn codeine instead of co-codamol. Regular full-dose paracetamol is as effective as co-codamol 8/500 (and won’t cause constipation). Soluble/effervescent formulations of paracetamol or co-codamol are not recommended due to high salt content (8 tablets contains 50% more sodium than recommended maximum daily intake). Co-dydramol is no longer in formulary (considered no more effective than regular paracetamol). Tramadol – less effective than other opioids in severe pain, potential for CNS effects, drug interactions and dependence. Tramadol is now a schedule 3 controlled drug and prescriptions must comply with CD handwriting requirements. Tramadol MR and Tramacet are non-formulary so should not be prescribed. Fentanyl patches - only for patients unable to tolerate oral opioids. Fentanyl ‘25’ patch equivalent to 90mg daily morphine. Suitable for stable pain only, due to long half life/gradual onset of action. Heat sources can increase absorption from patch potentially causing dangerous rises in fentanyl levels. Currently Fencino pataches provide best value for money for Solihull patients. Fentanyl lozenges and sublingual tablets are RED. Buprenorphine patches – specialist initiation in pain clinics, palliative care and patients withswallowing difficulties - supported by RICaD. (BuTrans 5 patch only equivalent to oral morphine 12mg/day). Oxycodone – usually on Palliative Care specialist advice only All controlled drugs should be prescribed by BRAND to avoid confusion between preparations Neuropathic pain -pregabalin as an option only after amitriptyline & gabapentin ). Prescribe pregabalin by brand in neuropathic pain. Lidocaine patches (Versatis) for specialist initiation, supported by a RICaD. Smoking cessation – Follow NICE & local guidance. NICE recommends only prescribing for patients committed to a target stop date and following an unsuccessful attempt at stopping, the NHS should not normally fund a further attempt within 6 months. Refer to Solihull Stop Smoking Service for behavioural support. Drugs for dementia – acetylcholinesterase inhibitors to be prescribed by Mental Health Trust only Anti-obesity drugs – should only be prescribed as part of an overall obesity management plan.

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5. Infections Antibiotics – local guidance is available in the Formulary and on the intranet - search by clicking on the links in the Index of Sections, or using <Crtl F>. A one page summary of treatment options for some of the most commonly seen infections in primary care is also available. Prescribe an antibiotic only when there is likely to be a clear clinical benefit. Please include appropriate clinical details when submitting swabs or other samples to microbiology. Microbiology results must always be interpreted in line with the patient’s clinical picture. Laboratory specialists are always available to provide further advice. Co-amoxiclav, cephalosporins and quinolones should be prescribed only in specific circumstances (see Guidance) due to risk of C difficile. Consider “no antibiotic” or “back up/delayed antibiotic” strategy for self-limiting upper respiratory tract infections. Antibiotic Delayed Prescription Strategy and Antibiotic Patient Leaflet to support delayed, or no prescription, strategy is available on intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/infection Leg ulcers are always colonised and antibiotics are rarely indicated, as they do not improve healing unless there is active infection.

6. Endocrine Insulins – NPH(Neutral Protamine Hagedorn) insulin first line, in accordance with NICE. New biosimilar (generic) glargine is now on the market, this is bioequivalent to Lantus. Insulin degludec is for hospital initiation only. Xultophy (liraglutide + degludec) is not on the formulary. High strength insulins (200 unit/ml and 300 unit/ml) are now commercially available. When prescribing insulins use the brand name to avoid confusion, and ensure the correct insulin dose and strength have been selected. Ensure all patients on insulin have insulin passport record and that it is kept updated. Gliclazide -gliclazide 80mg is equivalent to gliclazide m/r 30mg, but less than half the cost. Switch twice daily sulphonylurea (SU) to once daily SU only if compliance is an issue. Metformin – metformin 500mg m/r tablets are more expensive than standard release 500mg tablets and should only be prescribed 2nd line, to improve compliance, after adequate slow titration of standard release metformin has failed to adequately control the side-effects of metformin or the diabetes itself. If metformin m/r is indicated, please prescribe as Glucophage MR as this is more cost-effective. Gliptins - DPP4 (dipeptidyl peptidase 4)-inhibitors – these have modest hypoglycaemic effects. They have NICE approval for use as dual therapy added in to metformin when sulphonylurea (SU) is not tolerated or contraindicated in a patient at significant risk of hypoglycaemia or its consequences; or added in to a SU where metformin is not tolerated or contraindicated. They can also be used as part of a triple therapy regime when control of blood glucose remains or becomes inadequate and insulin is unacceptable or inappropriate. Sitagliptin, saxagliptin and alogliptin have evidence to show they do not increase the risk of CVD events compared with placebo, but none of the gliptins have any data to show they reduce the risk of microvascular or macrovascular complications or have any long-term safety data. Alogliptin is 1st-line on the formulary. Sitagliptin and linagliptin are also on the formulary. Other gliptins should not be prescribed for new patients. Gliptins should only be continued if the person has a reduction in HbA1c of at least 5.5 mmol/mol (0.5%) after 6 months of use.

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Pioglitazone – not to be used in patients with heart failure or history of heart failure, especially if prescribed with insulin. Contraindicated in patients with history of bladder cancer. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors (‘gliflozins’) – this new class of drugs have NICE approval for use as follows:

Dual therapy regimes Triple therapy regimes In combination with insulin

Empagliflozin NICE TA 336

Added to metformin if SU not tolerated or contraindicated

Added to metformin + SU, or Added to metformin + pioglitazone

Yes with/without other antidiabetic drugs

Dapagliflozin NICE TA 288

Added to metformin if SU not tolerated or contraindicated

Not recommended Yes with/without other antidiabetic drugs

Canagliflozin NICE TA 315

Added to metformin if SU not tolerated or contraindicated

Added to metformin + SU, or Added to metformin + pioglitazone

Yes with/without other antidiabetic drugs

All of the SGLT-2 inhibitors approved by NICE are on the formulary. Clinicians should only prescribe SGLT-2 inhibitors in line with NICE guidance because of limited outcomes and safety data. Note a recent MHRA Drug Safety Update (DSU) advises clinicians to test for raised ketones in patients on SGLT2 inhibitors with acidosis symptoms due to risk of diabetic ketoacidosis (DKA) with these drugs. Combination products containing oral hypoglycaemic agents are non-formulary – prescribe separately. Patients on dual or triple therapy which includes a newer agent where NICE clinical guideline criteria have not been met, should be reviewed and the newer agent stopped if the benefits of treatment have not been achieved Blood glucose testing strips (BGTS) – follow local guidelines for self-monitoring of blood glucose. The following meters are the preferred options on the formulary and will be acceptable for about two-thirds of patients who need to blood test. For more information see: http://www.birminghamandsurroundsformulary.nhs.uk/docs/acg/BSSEAPCBloodglucosemeterformularyguidanceFINAL.pdf?uid=568343707&uid2=20158209404722 Blood glucose meters (with compatible test strips and lancets):

GlucoRx Nexus meter GlucoRx Nexus test strips (packs of 50)

GlucoRx lancets (packs of 200)

Spirit NPOP meter CareSens N test strips (packs of 50)

CareSens Lancets (packs of 100)

For patients who need to check glucose and ketone levels:

Freestyle Optium meter Freestyle Optium blood glucose test strips

Freestyle Optium β-Ketone test strips (pack of 10)

Glucomen LX Plus meter Glucomen LX Sensor blood glucose test strips

Glucomen LX Ketone test strips (pack of 10)

Prednisolone – prescribe uncoated prednisolone 5mg tablets as no convincing evidence that enteric coated prednisolone tablets reduces the risk of peptic ulceration and may be less predictably absorbed.

Bisphosphonates – 1st line: generic alendronic acid once weekly. Bisphosphonates are not suitable for patients with swallowing problems or those unable to comply with complex administration directions. Monthly ibandronic acid is NOT on the formulary. Fosavance is non-formulary.

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7. Obstetrics, gynaecology & urinary tract Incontinence 1st line – oxybutynin or tolterodine; or trospium (patients > 65 years). 2nd line solifenacin if oxybutynin and tolterodine have failed. http://www.nice.org.uk/guidance/CG171/chapter/Patient-centred-care http://www.nice.org.uk/guidance/CG171/chapter/Patient-centred-care

If the first treatment for OAB or mixed UI is not effective or well-tolerated, offer another drug with the lowest acquisition cost. http://www.nice.org.uk/guidance/CG171/chapter/Patient-centred-care Mirabegron is recommended as an option for treating the symptoms of overactive bladder, in line with NICE TA 290, only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects. http://www.nice.org.uk/guidance/TA290 Erectile dysfunction(ED) 1st line: generic sildenafil - can be prescribed on the NHS for any man with ED, with no restriction on quantity to ensure adequate trial of therapy. Tadalafil is 2nd choice (on demand therapy only). Branded Viagra and other drugs used in ED can only be prescribed on the NHS in certain situations (see BNF 7.4.5), otherwise a private prescription is required. Avanafil, vardenafil, sildenafil chewable tablets and tadalafil once daily tablets are non-formulary. NHS prescriptions for ED drugs other than generic sildenafil must be endorsed ‘SLS’. DoH general guidance is that 1 treatment/week will be appropriate for most patients treated for erectile dysfunction. Department of Health NHS Executive Health Service Circular 1999/148 (amended 2009)

8. Malignant disease & immunosuppression LHRH agonists – for prostate cancer prescribe Prostap (within licence) if possible instead of Zoladex as more cost-effective. http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/malignant-disease-immunosuppression

9. Nutrition & blood Oral Nutritional Supplements If there are concerns about malnutrition, patients should be assessed using the Community Nutritional Screening Tool in the Solihull Guidelines for Oral Nutrition Support available on Medicines & Prescribing website. http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/nutrition-blood Food boosting should be tried 1st line. If Oral Nutritional Supplements are required, use Nutricia range (Fortisip, etc) and ensure patients are regularly re-assessed. A list of ‘off the shelf’ snack ideas to increase calorie and protein intake can be found on the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/nutrition-blood For further advice please refer to community dietitians Gluten-free products – follow Solihull Guidance on Prescribing of Gluten-free Foods on website for guidance on products and quantities: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/nutrition-blood. It is recommended that prescribing of GF foods is done once a month only to avoid prescribing more than the recommended monthly amount. Priority should be given to basic food items (bread, rolls, pasta, crackers, crispbread, pizza bases and breakfast cereals). Cake mixes and biscuits should not be prescribed, but can be bought by patients.

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Specialist Infant Formula - follow Solihull guidance on website for Prescribing of Specialist Infant Formula in Primary Care: http://nww.solihullccg.nhs.uk/index.php/nutrition-blood Lactose-free infant formulas (e.g. SMA-LF) and thickening formulas (e.g. SMA Staydown) can be purchased at similar cost to standard infant formula. Vitamin D – see local guidance for treatment recommendations and regimes using the most cost-effective licensed options: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/nutrition-blood.

10. Musculoskeletal system NSAIDs –All NSAIDs associated with increased risk of thrombotic events, especially high doses long term, also gastro-intestinal toxicity, especially in the elderly. Use lowest possible dose NSAID for shortest time possible, with regular review. 1st line: ibuprofen (up to 1200mg daily) or naproxen + PPI (diclofenac has similar risk of cardiovascular toxicity to coxibs). Ibuprofen m/r and naproxen e/c non-formulary as no advantage over plain tablets and more expensive. Gastroprotection – NSAID + PPI preferable to coxibs. Coxibs - No evidence of superior pain relief, increased thrombotic risk compared with traditional NSAIDs & much more expensive. Ibuprofen may reduce the cardioprotective effect of aspirin. If ibuprofen is unavoidable in a patient taking aspirin, give the ibuprofen at least 30 minutes after the aspirin. Glucosamine (+/- chondroitin) – Non-formulary. NICE guidance on OA does not recommend the supply of glucosamine on the NHS due to the lack of sufficient evidence of benefit. Methotrexate – To be prescribed as 2.5mg tablets ONCE A WEEK only, as an acute prescription, using the menu of options for directions on practice prescribing systems, specifying the day of the week to be taken. The total dose to be taken each week should be stated in mg and number of tablets. The quantity prescribed should not normally exceed 4 weeks to ensure appropriate monitoring is carried out before prescribing. Ensure that the methotrexate patient hand held booklet is updated whenever the patient is seen, and before prescribing. Topical NSAIDs – If topical NSAID indicated Fenbid (ibuprofen) gel is currently the most cost-effective topical NSAID (follow ScriptSwitch recommendations). Other NSAID gels are non-formulary.

11. Eye Ocular lubricants – follow ScriptSwitch recommendations for the most cost-effective preparation. Eye drop quantities – each eye drop container for glaucoma treatment should last for one month when used at licensed dose for one or both eyes. If a patient runs out sooner, check they are only using 1 drop and prescribe an acute one-off prescription only. Do not routinely prescribe 2 bottles/month.

12. Ear, nose & oropharynx Nasal steroid - 1st line: Beconase (beclometasone). Dental products – GPs should not be asked to prescribe dental products (toothpastes, mouthwashes, fluoride preparation or mouth ulcer preparations) that the dentist could prescribe themselves. GPs should not accept requests from patients to issues an FP10 for an item prescribed on a private prescription by their dentist during dental treatment as a private patient.

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13. Skin Emollients – follow local guidance and ScriptSwitch recommendations for the most cost-effective option. http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/skin-woundcare

14. Vaccines Green Book for information about vaccines and immunisations: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book Childhood vaccine information and schedule on NHS Choices: http://www.nhs.uk/Conditions/vaccinations/Pages/when-to-get-your-child-vaccinated.aspx PGDs for vaccines on Medicines & Prescribing website: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/pgds Travel vaccines – private prescription required for many travel vaccines - see BMA guidance on intranet

Wound Management Please refer to Solihull Wound Management Formulary for guidance. This can be accessed via: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/skin-woundcare. There is a summary card and a patient card for health professionals to record treatment. Solihull Community nurses should access routine dressings from the dressings stores located at each Community Services base. A prescribing budget has been made available to the Community Nurses so that if a non-stock product is necessary, they can order it via their own FP10s. Practices should not be asked to prescribe dressings or woundcare products (including compression bandaging systems and barrier creams) for patients receiving wound management care from Solihull Community Nurses.

Appliances Stoma care A toolkit, audit and guidance on monthly quantities used are available at: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/clinical-guidance-resources/stoma-urology-other-appliances Continence products A Formulary is being prepared by the ‘Joint Urinary Incontinence Formulary Group’, and will be uploaded onto the intranet once this is available.

Stockings Compression stockings should not be put on repeat prescription. Patients should be prescribed 2 stockings (or 2 pairs if both legs affected) to have one to wear while one is being washed and dried. Review and replace every 3-6 months if necessary. White TED stockings are not prescribable on an FP10 Therapeutic clothing (e.g. Skinnies, DermSilk) Therapeutic clothing items for children are expensive and should only be prescribed on specialist advice, on acute prescription only. Prescribe 3 items (one to wear, one ready for wear and one in the wash). Patients and carers should follow the manufacturer’s advice on washing so that items will not usually need to be replaced unless outgrown.

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HOW TO ACCESS THE FORMULARY METHOD 1: Access online via the intranet

Access Medicines & Prescribing website from Solihull CCG intranet Click on multi-coloured ‘Formulary’ button

The formulary will automatically open up and can be searched using <Ctrl F> New editions of the Formulary will automatically be uploaded here

METHOD 2: Access via the practice website

The location of the formulary on practice systems varies depending on individual practices. Check with your practice manager or prescribing lead where the formulary is located on your

practice system. It may be set up on the practice intranet or saved on the server with a shortcut to the desktop. The formulary can be searched using <Ctrl F> Ensure that you are always using the latest edition of the formulary. Most SystmOne practices have the formulary linked directly via the SystmOne home page

The Interface Formulary can also be accessed via the CCG public-facing internet site: http://solihullccg.nhs.uk/publications/the-services-we-offer-1/99-the-interface-formulary-1/file APC Formulary link: http://www.birminghamandsurroundsformulary.nhs.uk/ Click here for Birmingham & Solihull Mental Health Foundation Trust Formulary.

MEDICINES & PRESCRIBING WEBSITE

The Medicines & Prescribing website on the CCG intranet can be accessed via this link : http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing The website can be searched using the <Ctrl F> facility. Clinical information has been grouped together into therapeutic areas, incorporating policies, guidance, ESCAs, RICaDs and patient information. Resources include: Formularies Policies and Guidelines (national and local) Newsletters – Prescribing Matters + others ESCAs & RICaDs Prescribing Unlicensed Medicines for Children Patient information leaflets

Resources for Care Homes Community pharmacy services IFR process FAQs Contact details Links to other resources

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NEWSLETTERS The Medicines & Prescribing Team produces regular newsletters for prescribers in Solihull. These are e-mailed out at the beginning of each month and uploaded onto the website. Newsletters can be searched using <Ctrl F>. Please speak to your PSP if you would like to be added to the mailing list.

Prescribing Matters Prescribing Matters is a short monthly e-mail format newsletter that is put together by the Solihull Medicines & Prescribing Team. It contains important information on new drugs, formulary changes, new safety information, changes to drug licenses, and ideas for cost-effective prescribing. It is intended to be an easy way of keeping all prescribers in Solihull up to date. Current and previous issues can be accessed via the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/newsletters/prescribing-matters

Prescribing Matters Extra An occasional newsletter on a specific topic e.g. new audit SOPs, antibiotics, medicines waste. Accessible via the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/newsletters/prescribing-matters-extra

Case studies in Medicines Use An occasional newsletter for GPs and community pharmacists, to share stories and offer questions for reflection/learning, which could be shared with GP registrars and other colleagues. Accessible via the intranet: http://nww.solihullccg.nhs.uk/index.php/members/medicines-and-prescribing/newsletters/case-studies-in-medicines-use

Case studies in Cancer An occasional newsletter for GP practices to share stories and offer questions for reflection/learning which could be shared with GP registrars and other colleagues.

PRESCRIBING DATA Prescribing data is available to the practice in different ways: Practice Monthly Prescribing Report (comparative data graphs) Monthly report e-mailed out to practices again with the regular Prescribing Information Package. Graphs compare practice performance in a range of indicators with other practices within the locality and CCG. Most graphs compare data from the current period to data from the same period in the previous year. Indicators include over/under spend, antibiotics, analgesics, laxatives, respiratory indicators etc. Other reports can be accessed via NHS Business Services Agency Information Services. Please speak to your PSP for more information about this.

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USEFUL WEBLINKS

Website

Address

BNF& BNF-C (accessible via Medicines Complete or via smartphone app)

http://www.bnf.org/bnf/login.htm

Electronic Medicines Compendium Manufacturers’ Summaries of Product Characteristics

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

Medicines for Children Advice about giving medicines to children

http://www.medicinesforchildren.org.uk/

Green Book Vaccines & immunisations

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Drug Tariff online Prices of generics and appliances

http://www.nhsbsa.nhs.uk/PrescriptionServices/4940.aspx

National Institute of Health & Clinical Excellence (NICE) Technology Appraisals, and Clinical Guidelines

http://www.nice.org.uk

Midlands Therapeutics Review & Advisory C’tee (MTRAC) Primary/secondary care prescribing issues

http://centreformedicinesoptimisation.co.uk/mtrac

Scottish Intercollegiate Guidelines Network (SIGN) “Scottish NICE” – Evidence based Clinical Guidelines

http://www.sign.ac.uk/

Scottish Medicines Consortium (SMC) Information on newly licensed drugs

http://www.scottishmedicines.org.uk/Home

Medicines & Healthcare Products regulatory Agency (MHRA) Government agency responsible for ensuring that medicines and medical devices are effective and safe. Reporting ADRs via yellow card scheme.

http://www.mhra.gov.uk/index.htm

National Patient Safety Agency (NPSA) Patient safety alerts, etc. Reporting patient safety incidents.

http://www.npsa.nhs.uk/

NHS Evidence Access to Cochrane, Clinical Evidence, CKS etc

http://www.evidence.nhs.uk/nhs-evidence-content/journals-and-databases

NICE Evidence Search Medicines & prescribing information from NICE , BNF, QIPP

https://www.evidence.nhs.uk/

UKMi Medicines Information Medicines Information resources inc drugs in lactation

http://www.ukmi.nhs.uk/

Department of Health Homepage

https://www.gov.uk/government/organisations/department-of-health

UK Teratology information Service Medicines in pregnancy

http://www.uktis.org/

Public Health England Infectious disease

https://www.gov.uk/government/organisations/public-health-england

NaTHNaC Travel Health

www.nathnac.org

eMIMS Electronic MIMS

http://www.mims.co.uk/

Medicines Chest Costs & details of preparations available OTC without prescription

http://www.medicinechestonline.com/