Metformin MR to low cost branded generic (Sukkarto SR) Switch Protocol

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Metformin MR to low cost branded generic (Sukkarto SR) Switch Protocol Applies to HaRD CCG employed Pharmacists and Medicines Optimisation Technicians. These protocols are produced by the NY&AWC MM team hosted by HaRD CCG for use by their employed MM team members. They can be adopted for use by other healthcare staff working in GP practices across NY&AWC CCGs but HaRD CCG accepts no responsibility for the use and application of these protocols in these situations. External staff working to these protocols must agree with their own employer whether they are competent and able to work to these protocols. Rationale Generic prescribing is usually recommended as it is more cost effective than prescribing branded products. However the Drug Tariff price for modified release (SR) metformin tablets is significantly more expensive than some brandedgeneric products. The brand that offers good value is Sukkarto SR. This protocol describes a switch from generically written metformin MR tablets and also a switch from the more expensive brands Glucophage SR, Bolamyn SR, Glucient SR and Metabet SR - to the preferred low cost brand. The MM team has assessed all products in this category and the decision to recommend Sukkarto SR is on the basis of clinical and cost effectiveness factors. Method 1. Staff working to the protocol should be familiar with the current BNF advice and the Summary of Product Characteristics for medicines included in the protocol. 2. Check the practice has agreed to the protocol and a signed copy is in place. 3. Check for any extra exclusions or amendments to the protocol made by the practice. 4. Rearrange practice formulary/add do not use codes where used to prevent future inadvertent prescribing. Check prescribing support software prompts are in place where relevant. 5. Notify local pharmacies/dispensary of work being undertaken and inform any relevant practice staff e.g. dispensary staff. - Ensure pharmacies / dispensing practices are able to obtain stock via their wholesaler. - Liaise closely with pharmacies with regards to those patients who have their medication dispensed in a Monitored Dosage System to ensure switch is seamless for all. 6. Run a computer search to identify patients who are currently receiving prescriptions for metformin MR tablets 500mg and 1000mg (including all other brands mentioned above). 7. Use the data collection form (Appendix 1) and the medical records to record the following: Patient identifier Allergies checked Current prescription (generic or brand), including strength, dose and quantity Previous prescriptions (e.g. has patient had drug you are switching to before?) Metformin MR to Sukkarto SR low cost brand Page 1 of 7 NYAWC MMT

Contraindications Exclusions Patient referred to prescriber? Suitable to switch Y/N? State strength/dose/quantity switched to Record whether the patient is switched and letter sent 8. Identify patients to exclude, those considered suitable to switch now and those needing special consideration by prescriber. 9. If a patient is excluded, add a consultation note listing reasons why they are unsuitable. 10. For those patients who can be switched now or approved by prescriber; change repeat medication on computer from: Metformin MR (or Glucophage SR, Bolamyn SR, Glucient SR, Metabet SR) 500mg/1000mg Sukkarto SR 500mg/1000mg tablet (same dose / directions) 11. Ensure that the old medication is archived. 12. Send a letter to the patient advising them of the change. Liaise with practice staff to organise mail merge of letters and posting. At the end of the session, for all those changes that have been completed, a letter must be ready to send to the patient for information. 13. Add READ code 8BIr or XaJKo (on Systm One) drug changed to cost effective alternative for all patients switched. 14. Problem link drug to disease (where possible). 15. Inform relevant practice staff. 16. Use an activity log to review all changes made and to measure the effectiveness of the switch. Estimate cost savings made and present results back to the practice and organisation 17. Continue to monitor the long term outcomes of the switch e.g. cost savings via PPD data, complaints, problems encountered etc. Exclusions - do not switch 1. Pregnancy and breastfeeding. 2. Any patient under 18 years old (Sukkarto SR) is not recommended under 18 years old) 3. History of intolerance to Sukkarto SR or any of its excipients. Note to check excipient differences between current brand (unless currently prescribed generically) and Sukkarto SR* 4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption Metformin MR to Sukkarto SR low cost brand Page 2 of 7 NYAWC MMT

To flag up for special consideration by prescriber approval required via electronic task 1. Significant drug interaction with Metformin MR (see BNF Appendix 1 and data sheet (available at www.medicines.org.uk for further details). Also check prescribing systems for any interactions at the time of adding. Seek advice from pharmacist as to the significance of the interaction, and flag to the prescriber for consideration, rather than just excluding from the switch. 2. A patient suffering from any type of acute metabolic acidosis such as lactic acidosis or diabetic ketoacidosis. 3. A patient with diabetic pre-coma. 4. A patient with severe renal failure (GFR < 30 ml/min). Please note: the European Medicines Agency has undertaken a review of the use of metformin in moderate kidney disease and concluded that metformin can be prescribed in patients with a GFR rate between 30 and 59ml / min., but that it should be contra-indicated in patients with a GFR less than 30ml/min. Previously metformin was contra-indicated if the GFR was less than 60ml/min. This is now standard European advice regarding the use of metformin in patients with reduced renal function: the Summary of Product Characteristics for Sukkarto and all other metformin products are currently being updated to reflect this advice. 5. A patient with any acute conditions with the potential to alter renal function such as dehydration, severe infection, shock 6. A patient with any disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: - Decompensated heart failure, - Respiratory failure, - Recent myocardial infarction, - Shock 7. A patient with hepatic insufficiency, acute alcohol intoxication or alcoholism 8. Any patient that you are concerned may be unsuitable for switching, or other prescribing issue that you are concerned about. Points to discuss with practice 1. Who is the contact in the practice for the project? 2. Seek agreement from practice as to whether palliative care patients can be switched. Patients considered to be in the last few weeks of life would not normally be recommended for a switch. 3. Agree content of patient letter a possible form of words is attached below 4. Agree the number of repeats to issue for patients who are switched. 5. Any practice additions, deletions or amendments to the protocol. Metformin MR to Sukkarto SR low cost brand Page 3 of 7 NYAWC MMT

References 1. BNF online Accessed March 2017. 2. Sukkarto SPC Accessed March 2017. Agreement to protocol Please detail any amendments to the protocol here/or attach a copy of agreed changes: Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Please note that the practice representative signing this protocol agrees that: The practice will take responsibility for the notification of all relevant practice staff. The practice has made patients aware that their records are accessed by staff for these purposes eg: via practice leaflet, website or other communication and that the practice has applied appropriate restriction to the records of patients who have withdrawn consent. Metformin MR to Sukkarto SR low cost brand Page 4 of 7 NYAWC MMT

Possible letter Dear ~[Title/Initial/Surname] Your repeat prescription for Metformin MR / Glucophage SR* 500mg/1000mg* Tablets (*delete as appropriate) The practice has been reviewing its prescribing of Metformin MR / Glucophage SR* Tablets (*delete as appropriate). This is to ensure our patients receive the best treatment offering the best value to the NHS. As a result we have changed your future prescriptions to Sukkarto SR 500mg/1000mg* Tablets (*delete as appropriate) The strength and dose of Sukkarto SR 500mg/1000mg* Tablets (*delete as appropriate) is the same and you should not notice any difference in effect. Your medication will be changed automatically so please order your next prescription in the usual way. It would help the NHS save money if you would use up any remaining Metformin MR / Glucophage SR* 500mg/1000mg* Tablets (*delete as appropriate) first. If you have any queries regarding this letter please contact [insert name of contact, practice] and or [insert email of local CCG patient relations team] All medicines should be safely stored out of the reach of children. Yours sincerely ~ [Usual prescriber/registered prescriber/gp Prescribing Lead/Other] Agreement to letter Please detail any amendments to the letter here/or attach a copy of agreed changes: Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Metformin MR to Sukkarto SR low cost brand Page 5 of 7 NYAWC MMT

Appendix 1 - Data Collection Form; Metformin MR to Sukkarto SR Patient identifier: Current Metformin MR tablet strength, dose and quantity Previously had Sukkarto Y/N. If Yes, record reason why stopped Any contraindications/cautions with Sukkarto? If Yes, list and flag to prescriber Patient has an exclusion to switch to Sukkarto? Y/N Allergies or intolerances checked Y/N Renal function checked? Y/N Record if GFR <30ml/min Flag to prescriber? Y/N Record reason Preparation switched to strength & dose Patient switched? Y/N Letter sent? Y/N Metformin MR to Sukkarto SR low cost brand Page 6 of 7 NYAWC MMT amendments, including updated hyperlinks. Please use the online version to ensure use of the latest version.

Document version control Version State changes New version Actioned by Metformin MR to Sukkarto SR low cost brand Page 7 of 7 NYAWC MMT