Cannock Chase Clinical Commissioning Group South East Staffordshire and Seisdon Peninsula Clinical Commissioning Group Stafford and Surrounds Clinical Commissioning Group
Medicines Optimisation Team Standard Operating Procedure Audit: Simvastatin: updated advice on drug interactions
Aim
To identify all patients currently prescribed simvastatin and concomitantly prescribed amlodipine, amiodarone, diltiazem and/or verapamil. The dose of simvastatin in these patients should not exceed 20mg/day.
Rationale
Simvastatin is a HMG-CoA-reductase inhibitor. Simvastatin has been shown to reduce both normal and elevated LDL cholesterol concentrations. The risk of myopathy, myositis, and rhabdomyolysis associated with statin use is rare. Although myalgia has been reported commonly in patients receiving statins, muscle toxicity truly attributable to statin use is rare. Muscle toxicity can occur with all statins; however the likelihood increases with higher doses.
Atorvastatin 20mg should be offered as primary prevention of CVD to those who have a 10% or greater 10- year risk of developing CVD (QRISK2 ≥ 10%). It should also be offered as primary prevention to patients with type 2 diabetes who have a QRISK2 ≥ 10% and for primary and secondary prevention for those with CKD.
Refer to the full NICE guidance on Cardiovascular disease: risk assessment and reduction, including lipid modification for management.
There are contraindications to concomitant use with certain medicines and maximum dose recommendations when simvastatin is taken with a number of other medicines, as these interactions may increase plasma concentrations of simvastatin which is associated with an increased risk of myopathy and/or rhabdomyolysis.
The maximum recommended dose for simvastatin in conjunction with amlodipine, amiodarone, diltiazem and/or is now 20 mg/day.
Please read full guidance and full interaction lost at: https://www.gov.uk/drug-safety-update/simvastatin- updated-advice-on-drug-interactions
Audit criteria
Inclusion criteria : 1. All patients currently prescribed simvastatin and concomitantly prescribed amlodipine, amiodarone, diltiazem and/or verapamil.
Exclusion criteria: Exclude patients prescribed a total daily dose of simvastatin 20mg or less.
Method 1. Prior to commencing work, familiarise yourself with current BNF and MHRA advice on these products. 2. Check the practice has agreed to the protocol and a signed copy is in place.
Page 1 of 5 Version 1.0 Developed by Kirandeep Sangha April 2018 To be revised: June 2020 Approved By Medicine Optimisation Group: June 2018
3. Check for any extra exclusions or amendments to the protocol made by the practice. 4. Check prescribing support software prompts are in place where relevant. 2. Run a computer search to identify all patients who are currently receiving prescriptions for simvastatin (at a daily dose of above 20mg) and concomitantly prescribed amlodipine, amiodarone, diltiazem and/or verapamil. 5. Agree with practice how they would like this information communicated with the patient (GP review, telephone review). 6. These patients may need a dose change of their simvastatin or change to an alternative statin. 7. Repeat lipids and LFT’ after 3 months since dose/statin change and review accordingly. 8. Record on patient records the intervention has been made. 9. Problem link drug to disease (where possible). 10. Inform relevant practice staff. 11. Record the numbers/patients changed using an ‘activity log’ and pass results to practice. 12. Run the search on a monthly basis (or as agreed with practice) to identify new patients.
Notes for Practice Pharmacist/ nurse/GP: Points to discuss with practice 1. Who is the contact in the practice for project? 2. Agree whether the patients are to be contacted via letter, phone call or another means. 3. Agree content of patient letter – suggested letter attached. 4. Any practice additions, deletions or amendments to the protocol.
References: 1. GOV.UK (2017) Medicines and Healthcare products Regulatory Agency- Simvastatin: updated advice on drug interactions [Online] https://www.gov.uk/drug-safety-update/simvastatin-updated-advice-on- drug-interactions 2. BNF (2018) BNF. [Online] Available at: https://bnf.nice.org.uk/drug/ 3. Summary of Product Characteristics (2018) [Online]Available at: https://www.medicines.org.uk/emc/ (for the mentioned drugs)
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Appendix 1 – data collection form Data Collection Form
Patient Age Name, strength, dose Concomitant drug Indication Date of latest Has the Action to identifier: and quantity of drug prescribed (e.g. for statin? lipid profile patient’s take/taken amlodipine) medication been reviewed?
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Appendix 2 – Patient letter Short date letter merged Title Initial Last Name, Home Full Address (stacked) Home Address Postcode
Dear
Doctors at the practice regularly review that patients are being monitored safely in accordance to the medication they are taking. Our records show that you are prescribed Simvastatin and …………………..
When these drugs are prescribed together the dose of simvastatin should not exceed 20mg daily. The practice has reviewed your medication and would like to change your medication to simvastatin 20mg daily (or alternative statin-dose). Additionally, if you could have a lipid blood test done 3 months after the change.
If you have any questions regarding this letter please contact the surgery. You can also read the MHRA safety alert if you wish to do so on the following website: https://www.gov.uk/drug-safety- update/simvastatin-updated-advice-on-drug-interactions.
Yours sincerely
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Document Change History Version Date Editor Details of significant changes 1.0 14/03/2018 Kiran Sangha New Standard Template
Head of Medicine Optimisation Sam Buckingham Date 27/06/18 Cannock Chase, South East
Staffordshire and Seisdon Peninsula and Stafford and Surrounds Clinical Commissioning Group GP Prescribing Lead Claire Pilkington Date 27/06/18 SESSP Clinical Commissioning Group
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