Author: M. Dell- Practice Support Technician Date written: 02/03/2017 Updated June 2019 Review date (review annually): May 2020 Brand to generic medication switching Crawley Clinical Commissioning Group Horsham and Mid Sussex Clinical Commissioning Group Audit Tool: Brand to Generic Medication Switching
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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
Crawley Clinical Commissioning GroupHorsham and Mid Sussex Clinical Commissioning Group
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:
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
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.
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
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
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
Exceptions Patients on a branded medication that is not included in the list above.
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
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:
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
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
Crawley Clinical Commissioning GroupHorsham and Mid Sussex Clinical Commissioning Group
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
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
Appendix 2
Exclusion Form
Brand to Generic Medication Switching
Practice……………………………… Lead GP…………………………
Patient ID and DoB Brand, Strength Dose Reason for exclusion
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
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
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
Brand to Generic Medication Switching
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.