STANDARD OPERATING PROCEDURE (SOP) NO

Author: M. Dell- Practice Support Technician Date written: 02/03/2017 Updated June 2019Review date (review annually): May 2020 Brand to generic medication switching

Crawley Clinical Commissioning GroupHorsham and Mid Sussex Clinical Commissioning Group

Audit Tool:Brand to Generic Medication Switching

Author: M. Dell- Practice Support Technician Date written: 02/03/2017 Updated June 2019Review date (review annually): May 2020 Brand to Generic medication switching


This audit tool is provided by The Medicines Management Team NHS Crawley CCG and NHS Horsham and Mid Sussex CCG. It is intended to be used as an aid for practice staff to review patients in line with national guidance, and may be amended to suit individual practice or clinician preferences. It has been published as a simple Microsoft Word document to enable easy adaptation.

The information contained in the audit tool is correct at the time of production. Using this tool does not remove any of the professional obligations to prescribe safely by taking individual patient factors into consideration and clinician discretion with individual patients during the review process is essential. Staff using this tool must concurrently take full account of the practice’s internal governance and quality assurance policies, and work in line with the Data Protection Act 1998.

Brand to Generic Medication Switching

Introduction Generic medications are drugs that share the same quality of active substance(s) as the branded medication that the original marketing authorisation was given for e.g. reference medicine.

Generally speaking generic medications are cheaper for the NHS to purchase than the branded original medication, therefore there can be large savings made by switching patients from a branded medication to a generic alternative that has the same active substance(s) and licensed indications.

If a generic medication has been granted a license then it has been judged to be as clinically effective and as safe as the original reference medication when used to treat the same conditions at the same dose. There is little clinical evidence to suggest that interchanging between branded and generic medication has any adverse clinical consequences for the patient. The excipients may vary between the branded original and generic formulations and this needs to be considered if patients have demonstrated an intolerance or allergy to excipients in the past i.e. lactose intolerant

Reasons to prescribe brand specific medication (branded or generic) Drugs that have a narrow therapeutic index. Certain modified or controlled release drugs. Certain administration devices. Products with multiple ingredients. ‘Biosimilar’ medication To ensure adherence to medication where a change in appearance of medication or packaging

may cause patient to avoid taking medication or become confused. Where patient may have an allergy to an excipient within the mediation.

Aim To switch patients from a branded medication to a cost effective generic alternative of the same formulation. Ensuring the licensed indications are consistent.

Audit Standards

The main objective of this procedure is to ensure all patients that can be changed to a cost effective generic medication from a branded medicine are clinically appropriate to do so.

This should be done only when it has been agreed with the lead GP in accordance with the list of agreed alternatives in the inclusion criteria. Any allergies or intolerances that the patient may have must be checked against the proposed generic medication to ensure that it is safe for the patient to take.

Patient contact is important as the look and shape of the medication and packaging may change which may cause confusion and noncompliance so patients need to be informed of these changes.

Responsibilities The Lead GP must be informed of all potential changes to patients’ medication to include the following:



Any patients that are on a branded medication where a licensed generic is available in accordance with the list below.

Any patients that are taking branded medication with no record for the reason why e.g. allergy or compliance issues.

Patients who have recently started branded medication with no record of generic medication being prescribed.

The CCG Practice Support technician and pharmacist are responsible for searching for and identifying patients that may have their branded medication changed to generic alternative.

The patients’ journal should be checked and made sure it is up to date with all relevant information is listed. All patients that need further investigation should be included in Appendix 1.

Please note that all approved branded generic medication can be prescribed through the Optimise Rx System.Highlighted drugs are new additions since last update in May 2018.

Inclusion criteria

BNF Chapter

Generic Name Brand Name1 Macrogol_Co Oral Pdr Sach S/F Movicol1 Esomeprazole Tabs E/C 20mg /40mg Nexium1 Omeprazole Caps E/C 10mg/20mg/40mg Losec1 Sod Alginate/Pot Bicarb_Tab Chble 500mg Gaviscon Advance Tabs1 Loperamide Capsules 2mg Imodium Classic / Original1 Rabeprazole Tabs 10mg/20mg Pariet1 Ursodeoxycholic Acid Caps 250mg Ursofalk1 Lansoprazole Zoton1 Mebeverine Tab 135mg Colofac1 Peppermint Oil Capsules Mintec2 Ezetimibe Tabs 10mg Ezetrol2 Ezetimibe + simvastatin Inegy2 Rosuvastatin Tab 5mg/20mg/20mg/40mg Crestor2 Ivabradine Tabs 5mg/7.5mg Procoralan2 Atorvastatin Tabs10mg / 20mg / 40mg / 80mg Lipitor2 Clopidogrel Tabs 75mg Plavix2 Amlodipine Tabs 5mg / 10mg Istin2 Losartan Cozaar2 Irbesartan Tabs 75mg / 150mg / 300mg Aprovel2 Simvastatin Tabs 10mg / 20mg / 40mg Zocor2 Irbesartan/Hydchloroth_Tab 300mg/12.5mg Co-Aprovel2 Telmisartan tabs 20mg / 40mg / 80mg Micardis2 Candesartan Tabs 4mg / 8mg / 16mg / 32mg Amias2 Losartan Pot/Hydchloroth_Tab 50mg/12.5mg Cozaar-Comp2 Fenofibrate Caps 200mg / 267mg Lipantil Micro2 Eplerenone Tabs 25mg / 50mg Inspra2 Enalapril Tabs 5mg / 10mg / 20mg Innovace2 Doxazosin Tabs 1mg / 2mg Cardura2 Lisinopril/Hydchloroth_Tab 20mg/12.5mg Zestoretic2 Ramipril_Tab 2.5mg / 5mg / 10mg Tritace2 Losartan Pot/Hydchloroth_Tab 100mg/25mg Cozaar-Comp



2 Bisoprolol Tabs 1.25mg / 2.5mg / 5mg / 10mg Cardicor / Congescor2 Lisinopril 10mg / 20mg Zestril2 Atenolol Tabs 50mg / 100mg Tenormin2 Moxonidine Tabs 200mcg / 400mcg Physiotens2 Irbesartan/Hydchloroth_Tab 150mg/12.5mg Co-Aprovel2 Fluvastatin Caps 40mg Lescol2 Valsartan/Hydchloroth_Tab 160mg/25mg Co-Diovan2 Flecainide Tabs 100mg Tambocor2 Valsartan 160mg Diovan2 Irbesartan/Hydchloroth_Tab 300mg/25mg Co-Aprovel2 Quinapril Tabs 20mg / 40mg Accupro2 Nicorandil Tabs 10mg / 20mg Ikorel2 Nebivolol Tabs 5mg Nebilet2 Tranexamic Acid Tabs 500mg Cyklokapron2 Pravastatin Tabs 40mg Lipostat2 Spironolactone Tabs 100mg Aldactone2 Co-Amilofruse Tabs Frumil2 Atenolol_Oral Soln 25mg/5ml S/F Tenormin2 Losartan Pot/Hydchloroth_Tab 100/12.5mg Cozaar-Comp2 Indapamide Tab 2.5mg Natrilix2 Glyceryl Trinit_Sub P/Spy 400mcg Nitrolingual2 Valsartan/Hydchloroth_Tab 80mg/12.5mg Co-Diovan2 Sotalol Tabs 80mg Sotacor2 Naftidrofuryl Caps 100mg Praxilene2 Co-Tenidone Tabs Tenoretic2 Olmesartan Olmetec2 Isosorbide Mononitrate 60mg XL Monomil XL2 Isosorbide Mononitrate Capsules Elantan LA3 Mometasone Fur_Aq N/Spy 50mcg (140 D) Nasonex3 Montelukast Granules 4mg / Tabs (including chewable) 4mg / 5mg / 10mg Singulair3 Carbocisteine Caps 375mg Mucodyne3 Desloratadine Tabs 5mg Neoclarityn3 Ipratrop Brom_Inh Soln 500mcg/2ml Ud Ipratrop_Steri-Neb Soln3 Cetirizine Tabs 10mg Zirtek Allergy3 Fexofenadine Tabs 180mg Telfast3 Budesonide_Inh Soln 1mg/2ml Ud Vl Pulmicort Respule3 Ipratrop Brom_Inh Soln 250mcg/1ml Ud Ipratrop_Steri-Neb Soln4 Sumatriptan tabs 50mg / 100mg Imigran4 Zolmitriptan Tabs (inc Orodisp) 2.5mg / 5mg Zomig4 Pramipexole Tabs 88mcg / 180 mcg / 350mcg / 700mcg Mirapexin4 Quetiapine Tabs 25mg / 100mg / 200mg / 300mg Seroquel4 Quetiapine XL Son date or Biquelle4 Aripiprazole Tabs (incl Orodisp) 5mg / 10mg / 15mg Abilify4 Sertraline tabs 50mg / 100mg Lustral4 Rasagiline Tabs 1mg Azilect4 Olanzapine Tabs 2.5mg / 5mg / 10mg / 20mg Zyprexa4 Escitalopram 5mg / 10mg / 20mg Cipralex



4 Duloxetine Caps G/R 20mg 30mg / 40mg / 60mg Yentreve / Cymbalta4 Buprenorphine_Tab Subling 2mg / 8mg Subutex4 Donepezil Tabs (inc Orodisp) 5mg / 10mg Aricept4 Paroxetine Tabs 20mg 30mg Seroxat4 Modafinil Tabs 100mg / 200mg Provigil4 Risperidone tabs 500mcg / 1mg / 2mg / 3mg / 4mg Risperdal4 Betahistine Tabs 8mg / 16mg Serc4 Co-Codamol_Cap 30mg/500mg Solpadol / Tylex4 Riluzole tabs 50mg Rilutek4 Rizatriptan Tabs 10mg Maxalt4 Mirtazapine_Orodisper Tab 15mg / 30mg / 45mg Zispin4 Co-Codamol_Tab 30mg/500mg Solpadol4 Entacapone Tabs 200mg Comtess4 Amisulpride Tabs 400mg Solian4 Citalopram 20mg Ciprimil4 Granisetron Tabs 1mg Kytril4 Memantine Tabs 20mg Ebixa4 Risperidone_Oral Soln 1mg/1ml S/F Risperdal4 Rivastigmine caps 3mg Exelon4 Fluoxetine HCl_Oral Soln 20mg/5ml Prozac4 Orlistat caps 120mg Xenical4 Prochlorperazine tabs 5mg Stemetil4 Zopiclone Tabs 7.5mg Zimovane4 Memantine HCl_Oral Soln 10mg/ml S/F Ebixa4 Atomoxetine caps 10mg / 18mg / 25mg / 40mg / 60mg / 80mg / 100mg Strattera4 Methylphenidate Tabs 10mg Ritalin4 Ropinirole Tabs 500mcg Adartrel4 Rasagiline Tabs 1mg Azilect4 Dosulepin Tabs 75mg Prothiaden4 Citalopram HCl_Oral Dps 40mg/ml S/F Ciprimil4 Cinnarizine Tabs 15mg Stugeron4 Pregabalin (Recommended Axalid, Alzain or Rewisca after Lyrica patent expires July 2017) Lyrica4 Fentanyl Patches Mezolar Matrix or Matrifen4 Buprenorphine Patches Butec4 Oxycodone Shortec4 Oxycodone MR Longtec4 Methylphenidate Matoride5 Itraconazole Caps 100mg Sporanox5 Terbinafine Tabs 250mg Lamisil5 Valaciclovir Tabs 500mg Valtrex5 Ciprofloxacin Tabs 250mg / 500mg Ciproxin5 Co-Amoxiclav Tabs 250mg/125mg & 500mg/125mg Augmentin5 Fluconazole Caps 150mg Diflucan5 Fosfomycin Monuril6 Insulin Detemir Levemir6 Insulin Glulisine Apidra6 Alendronic Acid Tabs 70mg Fosamax



6 Ibandronic Acid_Tab 150mg Bonviva6 Risedronate Tabs 35mg Actonel6 Ibandronic Acid_Tab 50mg Bondronat6 Desmopressin Tabs 200mcg DDAVP / Desmotabs6 Raloxifene Tabs 60mg Evista6 Finasteride Tabs 5mg Proscar6 Pioglitazone Tabs 30mg / 45mg Actos / Glidipion6 Gliclazide Tabs 80mg Diamicron6 Metformin MR Sukkarto7 Tadalafil Tabs 5mg/10mg/20mg Cialis7 Vardenafil Tabs 5mg/10mg/20mg Levitra7 Desogestrel Tabs 75mcg Cerazette / Zelleta / Cerelle7 Sildenafil tabs 50mg / 100mg Viagra7 Solifenacin Tabs 5mg / 10mg Vesicare7 Tolterodine Tabs 1mg / 2mg Detrusitol7 Tamsulosin Caps 400mcg M/R Flomax / Diffundox / Tabphyn7 Levonorgesrel Tabs 1.5mg Levonelle One Step7 Trospium Tabs 20mg Regurin7 Alfuzosin Tabs 2.5mg Xatral8 Anastrozole Tabs 1mg Arimidex8 Letrozole Tabs 2.5mg Femara8 Bicalutamide Tabs 50mg Casodex8 Exemestane Tabs 25mg Aromasin9 Sevelamer Tabs 800mg Renagel9 Alfacalcidol Caps 250mcg / 1mg One-Alpha9 Sod Chlor_I/V Inf 0.9% 10ml Amp Mini-Plasco_Sod Chlor Inj 0.9%9 Sod Chlor_I/V Inf 0.9% 5ml Amp Mini-Plasco_Sod Chlor Inj 0.9%9 Water For Inj_10ml Amp Mini-Plasco_Water For Inj

10 Celecoxib Caps 100mg / 200mg Celebrex10 Leflunomide Tabs 10mg / 20mg Arava10 Baclofen_Oral Soln 5mg/5ml S/F Lioresal / Lyflex10 Baclofen Tabs 10mg Lioresal10 Ibuprofen_Gel 10% Ibuleve10 Piroxicam_Gel 0.5% Feldene10 Sulfasalazine Tabs 500mg Salazopyrin11 Dorzolamide/Timolol_Eye Dps 2%/0.5% Cosopt11 Brinzolamide_Eye Dps 10mg/ml Azopt11 Latanoprost_Eye Dps 50mcg/ml Xalatan11 Latanoprost/Timolol_Eye Dps 50mcg/5mg/ml Xalacom11 Brimonidine Tart_Eye Dps 0.2% Alphagan11 Dorzolamide_Eye Dps 2% Trusopt13 Mometasone Fur_Oint 0.1% Elocon13 Liq Paraf Light_Bath Add 63.4% Oilatum / Oilatum Junior13 Mometasone Fur_Crm 0.1% Elocon13 Aciclovir_Crm 5% Zovirax13 Amorolfine HCl_Nail Lacquer Kit 5% 5ml Loceryl

Exceptions Patients on a branded medication that is not included in the list above.



Patients who may have compliance issues if their medication is changed e.g. generic not suitable for an MDS

Patients who may have an allergy or intolerance to one or more of the excipients in the generic alternative.

Patients who have specific reasons confirmed by the clinician as to why their medication should not be changed. This will include patients who have switched previously but requested to go back to the branded original.

Patients on a medication that must be prescribed by brand for reasons of safety, bioequivalence and clinical effect.

GP Prescribing Lead, authorising on behalf of all partners Name: Signature: Date:Practice ManagerName: Signature: Date:Medicines Management Team Pharmacist*/Technician*(*delete as appropriate)Name: Signature: Date:



PROCESS

Identify Patients Multiple searches will need to be conducted to ensure all patients with multiple medications that can be changed from branded to generic are found.

Initial Cohort-The report should focus on repeat patients who have received treatment in the last 3 months.

Second Cohort- The report should focus on acute patients who have been initiated on a branded medication.

The report should be exported to an excel spreadsheet once the report has been run.

Data Collection The notes for each patient returned in the search must be checked and branded drugs with a licensed generic alternative should be noted.

Complete the data collection form (Appendix 1) for all patients that need review. Any actions that have been authorized must be noted on the patients’ record and the data

collection forma and a read code added if available.

Exclude patients Patients should have a review of their medication to ensure that they cannot be included in the audit for any of their medication.

Ensure initial reason for exclusion is still valid and that medication can definitely not be changed.

Excluded patients must be entered on to a separate data entry form (Appendix 2).

Intervention and evaluation of individual patients

Check patients medical history and current prescription and note: All branded medication currently used by the patient and licensed generic alternative. Cost of current medication and savings if changed to generic. All patients must have had a medication review within the last 12 months. Allergy status is clearly documented if found in the medication history

Action plan Once all data from the review is collected these must be sent to the lead GP for review.If the GP decides to change some or all of the recommended changes suggested then they may ask the pharmacist or technician to do these changes for them.Medication to be deleted must be noted in patients’ journal and a read code added if possible.

Patients may be contacted by phone or letter (see appendix 3) and a message left on their prescription or the GP may decide to talk to the patient themselves, the agreed approach must be discussed with the lead GP.

Re-audit This audit should be done every 6 months.

Confidentiality The Medicines Management Team must appropriately, safely and securely store all raw dataproduced as a result of the procedure and abide by confidentiality clauses within the terms andconditions of their employment at all times. Where possible the transfer of data should beundertaken using an encrypted memory stick, in the event of transferring patient identifiable paperdata the Medicines Management Team Member must demonstrate that reasonable actions havebeen taken to ensure its safe, secure storage and transportation.

Data Protection Act 2018Under the provision of the Act, it is the responsibility of each member of staff to ensure that allconfidential data, whether computerised or manual, is kept secure at all times. This includes datarelating to patients and to other members of staff. Data must not be disclosed to any unauthorisedperson and must be regarded as strictly confidential at all times. Failure to adhere to this instructionwill be regarded as serious misconduct and could lead to dismissal.

Author: M. Dell- Practice Support Technician Date written: 02/03/2017 Updated June 2019Review date (review annually): May 2020 Brand to generic medication switching


Appendix 1

Authorisation/Review Form

Brand to Generic Medication SwitchingPractice……………………………… Lead GP……………………………………………Date Data Collected……………………. Date Authorised……………………………

Patient ID and DoB

Age Brand, Strength Dose Generic/ Branded Generic Strength

Dose Suggestions

/comments (Particularly if indication/dose is off license)

GP sign Date patient informed/

Practice system updated



Appendix 2

Exclusion Form


Practice……………………………… Lead GP…………………………

Patient ID and DoB Brand, Strength Dose Reason for exclusion



Appendix 3

To be sent separately.

Dear

INFORMATION ABOUT YOUR REPEAT PRESCRIPTION

Until recently you have been prescribed the brand

………………………………………………………………………………………………………………

In future this medicine will be prescribed by the generic/generic brand name

……………………………………………………………………………………………………………….

Although the medicine may look slightly different, it is as safe and effective as your usual prescription. It is taken in exactly the same way as before. You should not notice any change or side effects.

If you have any queries regarding the change to your medication, please do not hesitate to contact the surgery.

Yours sincerely




Appendix 4

Action Plan

Action Points ActionedBy

Date Completed

1. All prescribers in practice have been informed of audit results

2. All patients identified are reviewed by the GP Lead

3. All medication highlighted for brand to generic change have been highlighted and potential cost savings shown.

Audit Results

Baseline Figures

Initial Audit

Date………………….

Re- Audit

Date………………….Number of patients prescribed a branded medication where a generic is availableNumber of patients who were originally prescribed a generic but switched to brand without a reason noted in patient record.Number of branded to generic switches in total.

Number of patients who have not had an annual review.Number of patients with a specified reason to be prescribed branded medication.

Repeat audit to be performed in every 6 months

STANDARD OPERATING PROCEDURE (SOP) NO

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