Prescribing Clinical Network. Medicine details

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1 Prescribing Clinical Network Surrey (East Surrey CCG, Guildford & Waverley CCG, North West Surrey CCG, Surrey Downs CCG & Surrey Heath), Crawley CCG and Horsham & Mid-Sussex CCG Application for change in colour classification GREEN - Non-Specialist Drugs GPs (or non-medical prescribers in primary care) are able to take full responsibility for initiation and continuation of prescribing BLUE - Specialist Input WITHOUT Formal Shared Care Agreement Prescribing initiated and stabilised by specialist but has potential to transfer to primary care WITHOUT a formal shared care agreement AMBER - Specialist Initiation WITH Shared Care Guidelines Prescribing initiated and stabilised by specialist but has potential to transfer to primary care under a formal shared care agreement RED - Specialist ONLY drugs Treatment initiated and continued by specialist clinicians BLACK NOT recommended Not recommended for use in any health setting across Surrey and NW Sussex health economy Name, brand name and manufacturer Licensed indication, formulation and usual dosage Traffic Light Status Various See Appendix 1 Current status Various See Appendix 1 Medicine details BLACK Proposed status Reason for requested change The BNF recommends that Where non-proprietary ( generic ) titles are given, they should be used in prescribing. This will enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service. The only exception is where there is a demonstrable difference in clinical effect between each manufactures version of the formulation, making it important that the patient should always receive the same brand; in such cases the brand name of the manufacturer should be stated. This position is supported by the CCG members of the Medicines Commissioners Group (MCG) with further information available in the document entitled Recommendations for appropriate prescribing of generic and branded medicines available on the PAD (click for link). The CCGs in Surrey have developed local policies to support local prescribers to prescribe cost effective generics when they are available and when it is clinically appropriate to do so. This strategy has worked to some extent but there remains opportunity savings of over 1 million per annum across the 7 CCG members of the PCN. The BMA Prescribing in General Practice guide (June 2015) states the following: Am I right, that as an NHS patient my GP must prescribe for me whatever I want? Under the NHS regulations your GP must prescribe for you any drugs that he or she feels are needed for Review date: Nov

2 your medical care. A patient is entitled to drugs that the GP believes are necessary, not those which 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. The Department of Health lists all drugs that the NHS is prepared to pay for in a list called the Drug Tariff. It is likely that most, if not all, the drugs you need are available through the NHS, however the Drug Tariff does have exceptions. Some drugs, like phosphodiesterase inhibitors (e.g. Viagra) listed in Schedule 11 will only be offered on the NHS to patients suffering from specified conditions. Similarly some products other than drugs, such as high energy or gluten free foods, are listed as Borderline Substances and may only be prescribed at NHS expense in defined circumstances. Other drugs or substances, listed in Schedule 10, cannot be prescribed at all on the NHS, such as Evening Primrose Oil, many vitamins, bath preparations, cough syrups and expensive brand names of some drugs. The Drug Tariff lists numerous generic drugs and the price that the NHS will fund. As an example, 28 x omeprazole 20mg capsules are listed at 0.91 (January 2017) whilst the branded equivalent Losec would cost the NHS Losec is not directly mentioned in the Drug Tariff so it could be considered that the NHS is not prepared to pay for Losec. However, this does not necessarily solve the dilemma as some drugs not listed in the drug tariff can be prescribed; only those listed in Part XVIIIA [Drugs, Medicines and Other Substances not to be ordered under a General Medical Services Contract] cannot be prescribed and currently this does not include branded products such as Losec. There is, however, a reasonable case to argue that if Losec is not specifically mentioned in the Drug Tariff and local policy recommends that generic omeprazole should be prescribed then it is "not available on the NHS." A legal precedent may also already be in place that shows that the NHS intends that if a product is available generically then the prescription should be written generically. During the 1990s when the benzodiazepines, Valium, Mogadon etc., became available generically, in order to ensure they were prescribed generically the NHS blacklisted the branded products. This was the first precedent set and following that regulation there was a strong movement to ensure prescriptions were written generically particularly for products that became available generically. THE MHRA requires generic manufacturers to meet stringent requirements to market generic products within the UK including comparative efficacy and safety compared with the originator products. The decision-making criteria to support colour classification by the Prescribing Clinical Network states the following for drugs to be given BLACK status (Not recommended for use in any health setting across Surrey and NW Sussex health economy): 1. Lack of evidence of benefit compared with standard 2. Lack of evidence of safety compared with standard 3. Less cost-effective than standard therapy. NICE guidance does not recommend On this basis, there would appear to be no justification for many branded products where generics are available. It is proposed that in instances where generic products exist and there is no clinical or other exceptional reason for prescribing a branded medicine, then the branded versions of these medicines should be given BLACK status. In order to support this proposal, an agreed list of branded products will be given BLACK status and will be highlighted as such on the Prescribing Advisory Database (PAD). It is important to note that it is only the branded product that would have BLACK status, the generic version will remain the same as previously determined. The initial (proposed) list is shown in Appendix 1. Note that this list will be subject to future updates as certain drugs lose their exclusivity. Review date: Nov

3 Cost implications to the local health economy Key Considerations The potential savings arising from the prescribing of generic medicines rather than their branded equivalents for each CCG within the PCN is shown in the table below CCG Total Spend (July - Sept 2016) Million Potential Savings July - Sept 2016) % of total spend Annualised Savings Crawley.56 30, % 122,536 East Surrey , % 128,523 Guildford & Waverley , % 139,533 Horsham & Mid Sussex , % 207,280 North West Surrey , % 272,356 Surrey Downs , % 26,736 Surrey Heath , % 71,611 Total (all PCN CCGs) ,6 0.62% 1,206,576 Information taken from the NHS Business Services Information Services portal (accessed 17/01/17) Annual saving per patient: Saving across the range of drugs the generic cost is approximately 7% of the equivalent branded cost. Average cost per item will vary according to the drug. It is estimated that the annual average saving per patient if changes were implemented across all drugs is approximately 100 per patient. Impact to current prescriber or medication initiator Existing prescribers should be informed of the change in status of relevant drugs and should take appropriate action. CCGs may wish to put mechanisms in place to support this process and manage patient enquiries. Impact to proposed prescriber or medication initiator Prospective prescribing should be in line with the proposed status the selected drugs. CCGs that use decision support software may wish to include relevant messages to highlight the status of drugs within the CCG. For drugs initiated in acute trusts, clinicians should be advised to prescribe or recommend by the generic name. Impact to patients The vast majority of prescriptions for the drugs within Appendix 1 are prescribed and dispensed generically and will have the same benefits / risks to patients as the originator brands. Patients who have been receiving branded products for some time may need reassurance that they are not receiving an inferior product. Patient information is available from This states that In the UK there are strict quality controls before a product licence is granted for brand (trade) named or generic versions of medicines. This means that a generic or brand name version of the same medicine will be of the same quality, and have the same action. Review date: Nov

4 Additional comments The list in Appendix 1 recommends that the majority of brands for the medicines listed should be given BLACK status, i.e. shown with a black background. However, there are a number that have been left uncoloured and require further discussion. These include: Combination drugs Patches Cerelle based on the existing recommendation that is currently on the PAD that recommends this brand when desogestrel 75mcg tablets are required Identified lead for development of necessary documents e.g. shared care agreement Name: Designation: Organisation: Estimated date of preparation: Declaration of interest Prepared by: Kevin Solomons, Head of Medicines Management, Surrey Downs CCG Declaration of interest: None Date: Reviewed by: Rachel Claridge, Lead Pharmacy Technician, Surrey Downs CCG Declaration of interest: None Date: Review date: Nov 2016

5 Appendix 1 List of Branded Drugs that are available generically that should be considered as BLACK status BNF Chapter Generic Name Brand Name 1 Macrogol_Co Oral Pdr Sach S/F Movicol 1 Esomeprazole Tabs E/C 20mg /0mg Nexium 1 Omeprazole Caps E/C 10mg/20mg/0mg Losec 1 Imodium Classic / Loperamide Capsules 2mg Original 1 Rabeprazole Tabs 10mg/20mg Pariet 1 Ursodeoxycholic Acid Caps 250mg Ursofalk 1 Lansoprazole Zoton 1 Mebeverine Tab 135mg Colofac 2 Atorvastatin Tabs10mg / 20mg / 0mg / 80mg Lipitor 2 Clopidogrel Tabs 75mg Plavix 2 Amlodipine Tabs 5mg / 10mg Istin 2 Losartan Cozaar 2 Irbesartan Tabs 75mg / 150mg / 300mg Aprovel 2 Simvastatin Tabs 10mg / 20mg / 0mg Zocor 2 Telmisartan tabs 20mg / 0mg / 80mg Micardis 2 Candesartan Tabs mg / 8mg / 16mg / 32mg Amias 2 Fenofibrate Caps 200mg / 267mg Lipantil Micro 2 Eplerenone Tabs 25mg / 50mg Inspra 2 Enalapril Tabs 5mg / 10mg / 20mg Innovace 2 Doxazosin Tabs 1mg / 2mg Cardura 2 Ramipril_Tab 2.5mg / 5mg / 10mg Tritace 2 Lisinopril 10mg / 20mg Zestril 2 Atenolol Tabs 50mg / 100mg Tenormin 2 Moxonidine Tabs 200mcg / 00mcg Physiotens 2 Fluvastatin Caps 0mg Lescol 2 Flecainide Tabs 100mg Tambocor 2 Valsartan 160mg Diovan 2 Quinapril Tabs 20mg / 0mg Accupro 2 Nicorandil Tabs 10mg / 20mg Ikorel 2 Nebivolol Tabs 5mg Nebilet 2 Tranexamic Acid Tabs 500mg Cyklokapron 2 Pravastatin Tabs 0mg Lipostat 2 Spironolactone Tabs 100mg Aldactone 2 Co-Amilofruse Tabs Frumil 2 Atenolol_Oral Soln 25mg/5ml S/F Tenormin 2 Indapamide Tab 2.5mg Natrilix 2 Glyceryl Trinit_Sub P/Spy 00mcg Nitrolingual 2 Sotalol Tabs 80mg Sotacor 2 Naftidrofuryl Caps 100mg Praxilene 2 Co-Tenidone Tabs Tenoretic 3 Mometasone Fur_Aq N/Spy 50mcg (10 D) Nasonex 3 Montelukast Granules mg / Tabs (including chewable) mg / 5mg / 10mg Singulair 3 Carbocisteine Caps 375mg Mucodyne 3 Desloratadine Tabs 5mg Neoclarityn 3 Cetirizine Tabs 10mg Zirtek Allergy Review date: Nov

6 3 Fexofenadine Tabs 180mg Telfast 3 Budesonide_Inh Soln 1mg/2ml Ud Vl Pulmicort Respule Sumatriptan tabs 50mg / 100mg Imigran Zolmitriptan Tabs (inc Orodisp) 2.5mg / 5mg Zomig Pramipexole Tabs 88mcg / 180 mcg / 350mcg / 700mcg Mirapexin Quetiapine Tabs 25mg / 100mg / 200mg / 300mg Seroquel Aripiprazole Tabs (incl Orodisp) 5mg / 10mg / 15mg Abilify Sertraline tabs 50mg / 100mg Lustral Rasagiline Tabs 1mg Azilect Olanzapine Tabs 2.5mg / 5mg / 10mg / 20mg Zyprexa Escitalopram 5mg / 10mg / 20mg Cipralex Duloxetine Caps G/R 20mg 30mg / 0mg / 60mg Yentreve / Cymbalta Donepezil Tabs (inc Orodisp) 5mg / 10mg Aricept Paroxetine Tabs 20mg 30mg Seroxat Modafinil Tabs 100mg / 200mg Provigil Risperidone tabs 500mcg / 1mg / 2mg / 3mg / mg Risperdal Betahistine Tabs 8mg / 16mg Serc Co-Codamol_Cap 30mg/500mg Solpadol / Tylex Riluzole tabs 50mg Rilutek Rizatriptan Tabs 10mg Maxalt Mirtazapine_Orodisper Tab 15mg / 30mg / 5mg Zispin Co-Codamol_Tab 30mg/500mg Solpadol Entacapone Tabs 200mg Comtess Amisulpride Tabs 00mg Solian Citalopram 20mg Ciprimil Granisetron Tabs 1mg Kytril Memantine Tabs 20mg Ebixa Risperidone_Oral Soln 1mg/1ml S/F Risperdal Rivastigmine caps 3mg Exelon Fluoxetine HCl_Oral Soln 20mg/5ml Prozac Orlistat caps 120mg Xenical Venlafaxine Tabs 37.5mg ViePax Prochlorperazine tabs 5mg Stemetil Zopiclone Tabs 7.5mg Zimovane Memantine HCl_Oral Soln 10mg/ml S/F Ebixa Methylphenidate Tabs 10mg Ritalin Tramadol Caps 50mg Zydol Ropinirole Tabs 500mcg Adartrel Co-Codamol Eff_Tab 30mg/500mg Solpadol Dosulepin Tabs 75mg Prothiaden Citalopram HCl_Oral Dps 0mg/ml S/F Ciprimil Cinnarizine Tabs 15mg Stugeron 5 Itraconazole Caps 100mg Sporanox 5 Terbinafine Tabs 250mg Lamisil 5 Valaciclovir Tabs 500mg Valtrex 5 Ciprofloxacin Tabs 250mg / 500mg Ciproxin 5 Co-Amoxiclav Tabs 250mg/125mg & 500mg/125mg Augmentin 5 Fluconazole Caps 150mg Diflucan Review date: Nov

7 6 Alendronic Acid Tabs 70mg Fosamax 6 Ibandronic Acid_Tab 150mg Bonviva 6 Risedronate Tabs 35mg Actonel 6 Ibandronic Acid_Tab 50mg Bondronat 6 Desmopressin Tabs 200mcg DDAVP / Desmotabs 6 Raloxifene Tabs 60mg Evista 6 Finasteride Tabs 5mg Proscar 6 Pioglitazone Tabs 30mg / 5mg Actos / Glidipion 6 Gliclazide Tabs 80mg Diamicron 7 Desogestrel Tabs 75mcg Cerazette / Zelleta 7 Desogestrel Tabs 75mcg Cerelle 7 Sildenafil tabs 50mg / 100mg Viagra 7 Tolterodine Tabs 1mg / 2mg Detrusitol 7 Flomax / Diffundox / Tamsulosin Caps 00mcg M/R Tabphyn 7 Levonorgesrel Tabs 1.5mg Levonelle One Step 7 Trospium Tabs 20mg Regurin 7 Alfuzosin Tabs 2.5mg Xatral 8 Anastrozole Tabs 1mg Arimidex 8 Letrozole Tabs 2.5mg Femara 8 Bicalutamide Tabs 50mg Casodex 8 Exemestane Tabs 25mg Aromasin 9 Alfacalcidol Caps 250mcg / 1mg One-Alpha 9 Mini-Plasco_Sod Chlor Sod Chlor_I/V Inf 0.9% 10ml Amp Inj 0.9% 9 Mini-Plasco_Sod Chlor Sod Chlor_I/V Inf 0.9% 5ml Amp Inj 0.9% 9 Mini-Plasco_Water For Water For Inj_10ml Amp Inj 10 Celecoxib Caps 100mg / 200mg Celebrex 10 Leflunomide Tabs 10mg / 20mg Arava 10 Baclofen_Oral Soln 5mg/5ml S/F Lioresal / Lyflex 10 Baclofen Tabs 10mg Lioresal 10 Ibuprofen_Gel 10% Ibuleve 10 Piroxicam_Gel 0.5% Feldene 10 Sulfasalazine Tabs 500mg Salazopyrin 11 Dorzolamide/Timolol_Eye Dps 2%/0.5% Cosopt 11 Brinzolamide_Eye Dps 10mg/ml Azopt 11 Latanoprost_Eye Dps 50mcg/ml Xalatan 11 Latanoprost/Timolol_Eye Dps 50mcg/5mg/ml Xalacom 11 Brimonidine Tart_Eye Dps 0.2% Alphagan 11 Dorzolamide_Eye Dps 2% Trusopt 13 Mometasone Fur_Oint 0.1% Elocon 13 Mometasone Fur_Crm 0.1% Elocon 13 Aciclovir_Crm 5% Zovirax 13 Amorolfine HCl_Nail Lacquer Kit 5% 5ml Loceryl 15 Lido HCl/Prilocaine_Crm 2.5%/2.5% Emla / Denela Review date: Nov