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STANDARD OPERATING PROCEDURE

Changing generic and branded metered dose aerosol

inhaler (MDI) containing fluticasone and salmeterol to the

branded generic Airflusal©

or Sereflo©

MDI

NHS Stockport Clinical Commissioning Group will allow people to access health services that empower them to

live healthier, longer and more independent lives.

NHS Stockport Clinical Commissioning Group 7th Floor Regent House Heaton Lane Stockport SK4 1BS

Tel: 0161 426 9900 Fax: 0161 249 4251 (Safehaven) Text Relay: 18001 + 0161 426 9900

Website: www.stockportccg.nhs.uk

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STANDARD OPERATING PROCEDURE FOR

Changing generic and branded metered dose aerosol

inhaler (MDI) containing fluticasone and salmeterol to the

branded generic Airflusal©

or Sereflo©

MDI

SUMMARY

The key objective of this SOP is to ensure that patients aged 18 years and above with a diagnosis of asthma currently prescribed generic or brand equivalent of Fluticasone and Salmeterol 125/25mcg MDI or Fluticasone and Salmeterol 250/25mcg MDI are switched to a more cost-effective branded generic i.e. either Airflusal© or Sereflo© MDI.

We also aim :

To make this change successfully, where possible in consultation with the patient, with as little disruption as possible for both the patient and the practice.

To ensure changes are appropriately documented and monitored

To ensure that the patient is consulted and involved in the process and that their confidentiality is respected throughout the process.

To ensure that the patient, practice staff and local pharmacies are informed of the change.

SCOPE

This work will include all patients identified as:

Aged 18 and over,

Prescribed either generic or branded fluticasone + salmeterol 125mcg/25mcg or 250mcg/25mcg

MDI inhaler on acute or repeat within the last 6 months,

Patients with a diagnosis of asthma ONLY (not COPD or asthma and COPD)

This work may also include patients previously switched to Sirdupla® lead GP to consider whether to

include or exclude this patient group and annotate the practice agreement accordingly.

This work will exclude patients currently prescribed either Airflusal© or Sereflo© MDI

The practice staff and the local pharmacies must be informed of the work before the changes are

made. This is essential to allow pharmacies time to alter their stock levels of affected products.

RESPONSIBILITIES

The overall responsibility for the work that is undertaken lies with the Lead GP and they should sign the CCG/Practice agreement, indicating the required protocol to be followed and responsibilities if different from the standard protocol. The Practice Nurse should also be informed and included as appropriate.

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The practice-based medicines co-ordinator (PBMC) is responsible for identifying patients using

MDI inhalers containing fluticasone with salmeterol as indicated and they will complete the

authorisation sheets. Once the changes have been agreed they may be responsible for carrying

out the computer change, sending out letters to inform patients and informing the rest of the

practice team and the pharmacies of the change, depending on the protocol followed.

Recommendations for change may be made by a member of the CCG Medicines Optimisation

Team or by a qualified prescriber at the practice

Note where there are huge numbers of patients for the changeover the practice may want to

consider other methods of managing the way patients are informed of the change instead

of sending out letters. Discuss other options with your prescribing adviser such as

attaching letters to prescriptions before issue, using pop-up messages, preparing sticky

labels for the prescriptions or a combination of these processes.

In practices who use EMIS web consider informing patients of the change by adding a patient note to the medication list e.g. “Airflusal© or Sereflo© MDI (delete as appropriate) inhaler contains fluticasone and salmeterol read information leaflet”.

RISK ASSESSMENT

There is no significant clinical risk associated with this program unless patients have had a previous

adverse reaction to Airflusal© and Sereflo© MDI. This is extremely unlikely as the brands are new to

the market in the UK. Prescribing by brand name will reduce the potential for confusion and ensure

that the same product is received each time. Patients may be unhappy about the medication being

changed and should be supported through this change.

GUIDANCE

This change can be managed by a standard letter process (protocol 1) unless the GP or practice

nurse states that the patient will need a consultation. If this is the case the practice should send a

standard non-urgent medication review invitation letter (protocol 2) to the patient or indicate on the

patient’s consultation record that a discussion is needed regarding this change at their next

consultation.

See notes above for alternative ways to manage this change as regards to informing patients of

the change of medication.

This is an opportunity for the clinicians to review the patient’s therapy, dose and to identify non-

compliance. If any issues are identified consider managing this change using protocol 2

Any patients who have not had a review of their asthma in over 12 months should be invited to

make a non-urgent appointment with the practice nurse for an annual review.

Airflusal© or Sereflo© MDI are therapeutically equivalent to the branded inhaler Seretide

evohaler® and other generic and branded preparations of salmeterol + fluticasone MDIs.

Spacer devices:

Note the use of a spacer is only recommended with Sereflo® 250/25, Airflusal 250/25 and

Airflusal 125/25 to which the Volumatic device and the AeroChamber Plus are both compatible.

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If a spacer is required for use with a fluticasone + salmeterol 125/25 MDI; it is advised that the

AirFluSal® 125/25 MDI is used as Sereflo 125/25 should not be used with a spacer as per

the manufacturer’s information.

Current use of any spacer device other than those mentioned should be highlighted on the

data collection sheet so alternative inhalers and / or spacer devices can be considered. These

patients could be managed using protocol 2 if necessary.

OTHER RELEVANT INFORMATION TO BE CHECKED WHEN REVIEWING Check the patient’s medical history and check

Past use of Airflusal© and Sereflo© MDI and reason for discontinuation if either has been tried previously, exclude if there is a clinically significant adverse effect specified

Date of last asthma review

Patients who have previously declined intended drug changes should also be managed by Protocol 2

Points for clinicians to note

Confirm patient is aged 18 years or above

Confirm current drug choice is in line with current guidelines

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THE PROCESS STAGES

The scope for the SOP should be determined including:

The lead GP for the work.

Who will review the patients and make the recommendations for change.

Who will authorise the changes e.g. GP or NMP

Any additional exclusion criteria should be agreed and added to the Practice Agreement.

How the patients will be informed and how they will be given the opportunity for discussion using

Protocol 1or Protocol 2 or any other process agreed.

Protocols for switching

Protocol 1 - Patient changes can be managed by a standard letter process or a combination of

pop-ups and sticky labels for the prescription (see note under responsibilities above).

Protocol 2 - Patient changes can be managed by a face to face consultation with the Practice

Nurse / GP or Medicines Optimisation Pharmacist

If the Practice would prefer not to send letters regarding this change then, you may at your discretion choose an alternative method of communication. Please discuss with your Medicines Optimisation Pharmacist to ensure suitability and document the chosen process on the Practice Agreement form. A protocol for the change process should be provided to the individual making the changes.

Processes such as prescription messages, slips, e-mailed letters and text messages have all been used in the past but are not as successful in maximising the numbers of patients’ changes, as the standard letter process.

The Practice Agreement must be completed

The practice details and the people responsible for each step of the audit must be completed on the form.

Any planned deviation from the standard protocol must be noted on the agreement before signing.

The agreement must have the date that the audit will commence and the proposed date of re-

audit.

The Designated Lead GP must be given the form to agree and sign on behalf of the Practice.

The PBMC (where one is available), CCG Medicines Coordinator or the prescribing support

pharmacy technician and prescribing adviser, if involved in making recommendations, must sign

the form.

If utilising Protocol 2, the reviewing clinician should indicate whether changes to the medication list should be made before the appointment or whether they will make them at the time. Careful consideration needs to be given to this as patients may need prescriptions between authorisation and the review appointment.

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A copy of the first section of the SOP (summary to guidance) must be given to each GP and nurse

in the practice and everyone named in the agreement for his or her reference and a full document

must be supplied if requested.

Document Preparation

Templates should be prepared for any letters that may be required and agreed by the Lead GP.

A patient information leaflet for Airflusal© or Sereflo© MDI is available, ask a member of

medicines optimisation team how to obtain supplies.

Informing staff involved

After the practice agreement has been signed, the practice staff and local pharmacies must be

informed of the proposed work that is to be carried out and the time frame over which the changes

will occur to allow time for the Pharmacy to reduce its stock levels of the discontinued medication

and obtain the new medication.

The CCG list of preferred brands should be updated and practices should be advised to place an updated copy in the locum pack. The locum pack on the CCG website should also be updated.

Searches

Search all current patients aged 18 and over prescribed the following aerosol MDI inhalers on acute or

repeat in last 6 months:

Fluticasone + Salmeterol 125/25mcg aerosol MDI

Fluticasone + Salmeterol 250/25mcg aerosol MDI

Seretide® Evohaler 125 and 250

Aloflute® 125/25 and 250/25 aerosol MDI

Consider whether to add or exclude patients taking the following medication as many practices

have only recently completed re-runs of this SOP. Whatever the lead GP decides, words to that effect

needs to be added to the practice agreement before it is signed.

Sirdupla® 125/25mcg and 250/25mcg MDI aerosol inhaler.

Exclude the following from your search

Airflusal© and Sereflo© aerosol MDI

All the equivalent Dry powder inhalers

Exclude patients with a diagnosis of COPD from this review but provide a list of these patients

to the practice CCG pharmacist for review separately (see below for how to exclude from this

search). If you are unable to produce a list of these patients for a separate review speak to

your CCG pharmacy technician.

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To exclude patients with a diagnosis of COPD:

1) Type “COPD” into codes

2) Selected all the relevant COPD codes (un-tick all asthma related codes)

3) Then under ‘feature builder’ highlight ‘include patients with clinical codes where’, then on

the line above tick ‘exclude’ (it has a red exclamation mark).

The report must only consider patients who are currently prescribed these medicines on acute or

repeat within the last 6 months.

The search results should be printed off and saved for 2 years for future reference.

The search can be used to identify instances of non-adherence and such patients should be highlighted on the authorisation sheet and called in for a medication review.

Authorisation sheets

These sheets may be filled in by the Practice Based or CCG Medicines Coordinator, but the “Suggestions for change” column must be left blank for the GP / Nurse or Medicines Optimisation Pharmacist to complete. A prescriber must authorise or decline, with a reason, each change and indicate the protocol by which the change should be managed.

EXCLUSION CRITERIA

Patients under 18 years of age

Patients with previous adverse reaction to Airflusal© or Sereflo© MDI

Past use of Airflusal© or Sereflo© MDI with a clear valid reason for discontinuation

Patients with a diagnosis of COPD

Patients already prescribed Airflusal© or Sereflo© MDI

Patients prescribed Sirdupla® 125/25mcg and 250/25mcg aerosol MDI – depending on practice

decision and agreement sheet

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PROTOCOLS FOR CHANGES

Before making changes ensure you are familiar with the warning that will appear when adding the new medication. This is caused by having the same medication on a drug list twice. This warning and ONLY this exact warning can be ignored. If any other warnings appear, it is not safe to continue making the change and the reviewer must be informed. If in any doubt, consult a prescriber.

A.

Protocol 1 – changing a patient’s medication by letter

Adding the new medication

The new medication Airflusal© or Sereflo© MDI inhaler must be added to the patient medication screen making sure that the correct strength and dose as specified on the signed authorisation sheets has been selected

The directions should remain the same as the old medication or as directed on the authorisation sheet.

If any warnings appear from the clinical system, stop at this point and delay continuing with this patient’s change until a prescriber can review the warning.

The number of repeats must be altered to match the number of repeats that remain of the old medication, or to cover the period until the next medication review.

B. Removing the old medication

When the new medication has been checked as correct and there is no alteration needed then the old medication can be deleted.

The reason for the medication being deleted should be added where possible; this must be “ Airflusal© or Sereflo© MDI SOP”.

A read code of 66R5/ (repeat medication changed/ stopped) must be added to the patient’s notes. A free text message of “ Airflusal© or Sereflo© MDI SOP.” must be added.

C. Communicating the change

A letter must be prepared using the appropriate template letter and including the practice’s usual heading unless a different method of communication is agreed.

The patient’s name and address must be taken from the patient’s computer record when preparing the letter. Add the date to letter.

The names of the old medication and the new medication must be stated on the letter.

An updated repeat medication slip should be included with the letter if possible when posting.

The letter must be completed and placed in the addressed envelope if using non- electronic communication, before moving on to the next patient.

Repeat the process A-C for each patient where necessary. Any letters must be produced on the same day as the computer record is changed.

Once all the relevant patients have been changed then a final check search is to be completed that will flag up any patients where the original medication was not removed. Create a new search including patients taking both original inhalers and Airflusal© or Sereflo© MDI inhaler. This will bring up any patients who have been left on both the original and the new medication.

NOTE If an alternative method of informing the patients of the change is to be used by the practice the full details of this method which has been discussed with the prescribing adviser should be agreed with the lead GP. The details should then be added to the practice agreement before it is signed.

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A.

B.

C. D. E. F.

Protocol 2 – Changing medication through face to face consultation

Setting up appointments

The reviewing clinician should agree the dates and times they will be available for medication change clinics.

Patients may be phoned by the reviewer to conduct an initial discussion and assessment of the need for a face to face appointment. If agreement is achieved with a phone call then changes should be documented as per protocol 1 and if necessary confirmed be letter.

If the patient and reviewer agree a face to face appointment is necessary agree an appointment time and confirm the invitation to attend by letter

If the patient is not contacted by the reviewer then send the template letter.

Preparing the invitation letter (if required)

The appropriate letter should be prepared requesting that the patient make an appointment with the consulting clinician.

The patents name and a 2nd identifier should be added to the Tracker.

The patient’s name and address must be taken from the patient’s computer record when undertaking the change if posting the letter and the letter must be printed and placed in the addressed envelope before moving on to the next patient.

If using e-mail each letter should be prepared and mailed before moving on to the next patient

An alert should be added to the patients record so anyone viewing the record is aware of the proposed change

Making the changes

If the reviewing clinician is not to make the change at the appointment, make the changes as per A and B in Protocol 1

Repeat the process A-C for each patient where necessary.

Tracking responses

Patient’s response to the Protocol 2 letter should be tracked. Changes should be made for any non-responders within the time specified in the letter (usually 14 days) to ensure changes can be progressed as per protocol 1.

Consultation with the reviewing clinician

The aim of the consultation is to engage the patient in the change process and gain concordance and adherence. The patient’s concerns should be heard and addressed. If changes are not made before the consultation they should be completed at the time as per this protocol.

If agreement is not achieved, add the read code (8B30- drug declined) and comprehensive details of the rationale for not making the change into patient’s notes.

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FOR ALL PATIENTS Patient Dissent

Any patient who contacts either the practice or NHS Stockport CCG with a valid reason as to why their medication should not be changed should be referred to the Prescriber/ Medicines Optimisation Pharmacist and if the outcome is a decision not to change, the patient should have a Read code of 8B30 (drug declined) added to the notes along with the message “patient does not wish to change” and the reason why.

Keeping a record

The printed list of patients identified from the report must be marked to show those patients that have changed and the patients who could not be changed.

Documentation containing patient information must not be removed from the practice.

Any documentation that you have produced must be placed in a designated file held within the practice and retained for 2 years

Details of any consultations either face to face or by telephone should be recorded in the patient’s record

Safety

Should there be any doubt with patients’ records, refer to the Medicines Optimisation Pharmacist or GP

Three months after the SOP is completed, the search should be run again to see if any patients have had the original medication brought back from past to repeat prescription. Any patients brought up in this search should be flagged up to the prescribing advisor for appropriate action.

Patients changed who are unable to take the new medication

For any patient changed to new medication who is subsequently unable to tolerate it the reason for discontinuation and any ADR should be recorded

They should not automatically be changed back to their original medication but a review conducted to select the most cost effective alternative. (See Guidance)

Prepared by: Colette Mitha Designation: Practice Support Pharmacist and Jacqueline Coleman Prescribing Adviser Pharmacist Approved by: Dr Simon Woodworth Designation: Medical Director Date approved: September 2018 This SOP will be reviewed within 3 years of approval but may be reviewed sooner if there is a significant change in practice, prices, guidance or a safety concern

Planned Review Date – September 2021

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Practice agreement for changing generic and branded metered dose aerosol inhaler (MDI) containing fluticasone and salmeterol to the branded generic Airflusal© or Sereflo© MDI

Practice Name…………………………………………………………………………………………………

I / we agree to adhere to this protocol to undertake the change from generic and branded metered dose aerosol inhaler (MDI) to Airflusal© or Sereflo© MDI (delete as appropriate) in suitable patients

I / we agree that the following are criteria for exclusion from the SOP and will be considered on a case by case basis to be managed by the GP

o Patients under 18 years of age

o Patients with previous adverse reaction to Airflusal© or Sereflo© MDI

o Past use of Airflusal© or Sereflo© MDI with a clear valid reason for discontinuation

o Patients with a diagnosis of COPD

o Patients already prescribed Airflusal© or Sereflo© MDI

o Patients prescribed Sirdupla® 125/25mcg and 250/25mcg aerosol MDI – depending on

practice decision (delete as appropriate)

I / we agree that the guidance on dose selection given in the guidance is appropriate for our patients and patients can be reviewed by the Practice Nurse, GP or Medicines Optimisation Pharmacist

I / we agree that all changes will be authorised by a GP or Non-Medical Prescriber.

I / we agree that the reviewer will indicate which patients will be informed of a change by letter (Protocol 1) which provides details of how they can gain more information and who will be managed through face to face consultation (Protocol 2). Changes for Protocol 2 patients will be made by the reviewing clinician during a consultation or the supporting PBMC/ technician before the appointment

I / we agree for the PBMC/ Medicines co-ordinator to undertake authorised changes and send out the appropriate letters

I / we agree that where a patient has a complaint the normal practice complaints procedure will be followed

I / we agree that the follow up detailed in the SOP is necessary (and that systems have been put in place to ensure this is completed)

Date program will commence:………………………………

Lead GP on behalf of the practice Name__________________ Signature______________________ Date_________

Designated Reviewer (GP/ Nurse / NMP/ Pharmacist/ Technician) Name__________________ Signature________________________ Date______ Name__________________ Signature________________________ Date______ Name__________________ Signature________________________ Date______

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PBMC or Medicines Optimisation Technician or Medicines Co-ordinators Name__________________ Signature________________________ Date______

Name__________________ Signature________________________ Date______

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Authorisation form for changing generic and branded metered dose aerosol inhaler (MDI) containing fluticasone and salmeterol to the branded generic Airflusal© or Sereflo© MDI (delete as appropriate)

Practice Name:………………………………. Date Data Collected: ………………………. Date Authorised:…………….

Patient’s Name And 2

nd identifier

Inhaler Strength & Dose

Indication Spacer Device (if

used)

Relevant ADR or

refusal to accept

changes

Switch to Airflusal

© or Sereflo

©

(Y/N) Include Strength & Dose

Protocol 1/2

G.P. Authorised

PBMC changed

Savings (£/28 days)

Shaded columns to be completed by reviewer and authoriser. If reviewer or authoriser is not a GP indicate who completes relevant columns.

Signature of reviewer: Print Name____________ _______________ Date______________

Signature of prescriber: Print Name____________ __________ _____ Date______________

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Protocol 1- Sample letter to Patients Prescribers Name Practice Name

Street Name Stockport

Postcode

Private and confidential Date

Patient Name House Number and street name Town Postcode

CHANGES TO YOUR MEDICATION

We have been reviewing medication following advice from NHS Stockport Clinical Commissioning Group which recommends the use of …………….. (add in name of practice choice i.e.Airflusal© or Sereflo©) inhaler.

You are currently using ………………………………(add name of current inhaler) at a dose of ……………………(add in strength and the directions)

We would instead like you to start using ………………………………(add name of new inhaler) at a dose of ……………………(add in strength and the directions )in the same way as before.

………………………..(add in name of practice choice Airflusal© or Sereflo© MDI) contains exactly the same medication as the inhaler you have been using and has been shown in practice to be equal to the main brand inhaler. There should be no changes in the benefits or the side effects of using this medication.

Please finish your supply of the old inhaler before starting your new inhaler.

If you have any queries regarding this change, please contact the surgery and arrange to speak to …………………………………. (a named person should be given)

Yours sincerely

Lead GP On behalf of (Dr X and Partners)

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Protocol 2 template letter for consultation Prescribers Name

Practice Name Street Name

Stockport Postcode

Private and confidential

Date Patient Name House Number and street name Town Postcode Dear (add patient’s form of address as per usual practice procedure) Re Prescription Review We are reviewing all our patients who are prescribed ………………………..(add inhaler under review) following advice from NHS Stockport Clinical Commissioning Group. We would appreciate it if you could make a non-urgent appointment with _______________(give name) to talk about necessary changes to the medicines you are currently taking. You are currently using ………………………………(add name of current inhaler) at a dose of ……………………(add in strength and the directions)

We would instead like you to start using ………………………………(add name of new inhaler) at a dose of ……………………(add in strength and the directions )in the same way as before.

Please refer to the patient information leaflet you receive when you obtain your inhaler from your community pharmacy……………………………. (add in name of practice choice Airflusal© or Sereflo© MDI) contains exactly the same medication as the inhaler you have been using and has been shown in practice to be equal to the main brand inhaler. There should be no changes in the benefits or side effects of taking this medication.

We would not wish to make the change before discussing this with you but. Should you decide an appointment is not necessary, or if you no longer take the medicine, please let us know we will then amend your medication list or proceed with the change. We will then write to you confirming the details of the changes made.

If we do not hear from you within ……….. (insert number of days, (suggest 14 as a standard)) we will presume you accept the changes and amend your repeat prescription accordingly Yours sincerely Dr _____________ On behalf of Dr X and Partners

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Protocol 2 Monitor

Patient name & no Date Protocol 2 letter sent Date change can be implemented if no contact