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Standard Operating Procedure (SOP) for changes from: GENERIC ...

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<strong>Standard</strong> <strong>Operating</strong> <strong>Procedure</strong> (<strong>SOP</strong>) <strong>for</strong> <strong>changes</strong> <strong>from</strong>:<br />

<strong>GENERIC</strong> VENLAFAXINE MODIFIED RELEASE CAPSULES TO <strong>GENERIC</strong><br />

VENLAFAXINE MODIFIED RELEASE TABLETS<br />

November 2010<br />

Prepared by-Medicines Management Team<br />

Dudley PCT<br />

Background<br />

A principle duty of the PCT Medicines Management and Practice Based Pharmacist Teams<br />

is to recommend and facilitate <strong>changes</strong> to prescribing practice to ensure good quality, safe,<br />

evidence-based and cost effective medicines use. This can include recommendations to a<br />

practice that they use alternative products to those already being prescribed, necessitating a<br />

‘planned change to patient’s medication’<br />

Objectives<br />

• To ensure that where appropriate patients receiving generic modified release<br />

venlafaxine (75mg and 150mg) capsules are changed to the equivalent medication<br />

prescribed as generic venlafaxine modified release tablets<br />

• To make this change with as little disruption as possible <strong>for</strong> both the patient and the<br />

practice.<br />

To ensure that the patient, practice staff and local community pharmacists are in<strong>for</strong>med of<br />

the change.<br />

Scope<br />

All patients prescribed generic Venlafaxine modified release capsules<br />

<strong>Procedure</strong><br />

Actions needed At Each Practice<br />

An Action plan needs to be produced to cover risk minimisation and agree mechanism <strong>for</strong><br />

in<strong>for</strong>ming patients. Decisions could include<br />

• Call patients in<br />

• Telephone contact<br />

• Patient letter, which will be printed on Practice headed paper, (Examples on page 4).<br />

• See patients individually at routine clinic appointments<br />

• Face to face medication review clinics with pharmacist or by other means which must<br />

be agreed and documented<br />

Planned <strong>changes</strong> to patient’s medication should only be made after the patient and/or carer<br />

has been in<strong>for</strong>med of the change and with the patient’s consent. If the patient is unable to<br />

positively contribute to the review process, the involvement of an advocate may be<br />

appropriate, following the Code of Practice <strong>for</strong> the Mental Capacity Act


Preparation and Agreement of Practice<br />

• A GP partner to agree to planned change to patient’s medication and sign ‘Practice<br />

Agreement’ Form. Same GP partner takes responsibility <strong>for</strong> discussing and agreeing<br />

proposed planned change to medicines with other GPs in practice.<br />

• Responsible pharmacist ensures all GPs in practice have been in<strong>for</strong>med of proposed<br />

planned change to patient’s medication and communicates in agreed practice<br />

manner.<br />

• Template letter prepared by PCT Medicines Management Team to in<strong>for</strong>m patients of<br />

the planned change to their medicines. Letter must explain reason <strong>for</strong> planned<br />

change to medicines, detail exactly how prescription has changed, contact details in<br />

case of query and how and when they should obtain new prescription.<br />

• Capacity to see patients face to face in a clinic to be assessed<br />

• GP agreeing planned change to patient’s medication to approve method of in<strong>for</strong>ming<br />

patients, either at routine clinic appointments, at face to face medication review clinics<br />

with pharmacist or by proposed patient letter, which will be printed on Practice<br />

headed paper, or by other agreed and documented means. Lead GP should see,<br />

approve and sign the ‘template letter’ <strong>for</strong> use in practice. Example attached on page<br />

4.<br />

• Any patients that practice wants excluded <strong>from</strong> the planned change to patient’s<br />

medication should be agreed now.<br />

• Agree a date <strong>for</strong> planned change to patient’s medication to start<br />

• Agree who in the practice will in<strong>for</strong>m patients and/or send letters.<br />

In<strong>for</strong>ming the Community Pharmacists<br />

• Two weeks prior to the planned change to medicines commencing, the PCT<br />

Medicines Management Team should in<strong>for</strong>m local community pharmacies. Visits or<br />

telephone contact by Practice Based Pharmacist are also recommended.<br />

Undertaking the planned change to medicines<br />

• Run a report <strong>from</strong> the practice computer of all patients with a current active repeat of<br />

the drug to be changed.<br />

• Ensure that no patient on the list has died or recently moved away. (Check with<br />

Practice staff)<br />

• Systematically work through the patient list. Delete any patient that doesn’t fit specific<br />

change criteria. Agree list with GPs and decide on most appropriate method to<br />

communicate with individual patients.<br />

• Undertake planned change to patient’s medication of all suitable patients. Amend the<br />

patient’s computer prescription record to the new drug and discontinue old drug,<br />

recording reason <strong>for</strong> change. Authorise agreed number of repeats and READ code<br />

entry in patient’s history detailing change and any monitoring requirements.<br />

• Communicate planned change to patient’s medication to patients<br />

• Provide list of patients changed to GPs and reception staff to help deal with any<br />

queries.<br />

• Refer to Repeat Dispensing Protocol <strong>for</strong> communicating <strong>changes</strong> to patients that are<br />

part of this scheme<br />

Monitoring<br />

• Arrange and maintain any follow up monitoring<br />

Confidentiality<br />

Patient in<strong>for</strong>mation used and seen shall be treated in the strictest confidence and not be<br />

divulged to any third party without the express permission of the Practice.<br />

PBPs should not take any patient identifiable data <strong>from</strong> the practice premises at any time.<br />

Work taken outside the practice should be anonymised<br />

Patient level data e.g. patient interventions, submitted to the PCT should also be<br />

anonymised.<br />

PBPs should agree a safe haven <strong>for</strong> storage of work within the practice.<br />

The unauthorized use or disclosure of patient or other personal in<strong>for</strong>mation is a disciplinary


matter liable to the contract being terminated <strong>for</strong>thwith.<br />

Dudley PCT – Medicines Management Team<br />

Practice Planned Change To Medicines Agreement Form<br />

Practice<br />

I agree that the planned change to medicines outlined below should go ahead according to<br />

the PCT <strong>Standard</strong> <strong>Operating</strong> <strong>Procedure</strong> and Drug Specific Protocol. I have in<strong>for</strong>med all other<br />

GPs and relevant staff working at the practice, and have approved the proposed planned<br />

change to medicines letter and additional methods of communication with patients.<br />

Signed___________________________________________Date__________________<br />

Name__________________________________________________________________<br />

Current Product<br />

Replacement Product<br />

Original dose & frequency<br />

New product dose and frequency


Appendix 1<br />

Practice Heading<br />

SAMPLE LETTER 1<br />

Date<br />

Dear<br />

Following a review of your medication there has been a change to the <strong>for</strong>mulation of<br />

your venlafaxine. It will now be prescribed as TABLETS. There has been no change to<br />

the overall dose you take each day.<br />

This change is in line with local advice given to us by Walsall and Dudley Mental<br />

Health Trust which suggests the tablet <strong>for</strong>mulation should be used as the first line<br />

treatment option if venlafaxine is required.<br />

There has been no change to the actual medicine you receive, the only difference is<br />

that it is a tablet rather than a capsule. So there should be no change to the benefit<br />

you receive <strong>from</strong> your current treatment.<br />

You will notice that the tablet is much smaller than the capsule <strong>for</strong>mulation and<br />

there<strong>for</strong>e potentially easier to swallow.<br />

Your new prescription will read<br />

Venlafaxine _____ XL Tablets<br />

Take 1 daily<br />

We hope that you are happy with this change, if you have any queries please contact<br />

the practice.<br />

Please finish off your old supply of medication be<strong>for</strong>e starting your new one.<br />

Yours sincerely


Appendix 2<br />

Practice Heading<br />

SAMPLE LETTER 2<br />

Date<br />

Dear<br />

Following a review of your medication there has been a change to the <strong>for</strong>mulation of<br />

your venlafaxine. It will now be prescribed as TABLETS. There has been no change to<br />

the overall dose you take each day.<br />

This change is in line with local advice given to us by Walsall and Dudley Mental<br />

Health Trust which suggests the tablet <strong>for</strong>mulation should be used as the first line<br />

treatment option if venlafaxine is required.<br />

There has been no change to the actual medicine you receive, the only difference is<br />

that it is a tablet rather than a capsule. So there should be no change to the benefit<br />

you receive <strong>from</strong> your current treatment.<br />

You will notice that the tablet is much smaller than the capsule <strong>for</strong>mulation and<br />

there<strong>for</strong>e potentially easier to swallow<br />

The advantage of using these tablets is that they are available in a higher dose tablet<br />

which means you need to take fewer tablets each day.<br />

You are currently taking<br />

Venlafaxine 75mg MR Capsules<br />

Venlafaxine 150mg MR Capsules<br />

Take 1 daily<br />

Take 1 daily<br />

Your new prescription will read<br />

Venlafaxine 225mg XL Tablets<br />

Take 1 daily<br />

We hope that you are happy with this change, if you have any queries please contact<br />

the practice.<br />

Please finish off your old supply of medication be<strong>for</strong>e starting your new one.<br />

Yours sincerely


Appendix 3<br />

Sample Prescription Note to be attached to Repeat prescriptions.<br />

(Please note this not take into account dose <strong>changes</strong> when optimising to a higher strength of<br />

venlafaxine tablets)<br />

Dear Patient<br />

CHANGE TO YOUR VENLAFAXINE<br />

Following a review of your medication there has been a change to the <strong>for</strong>mulation of<br />

your venlafaxine. It will now be prescribed as TABLETS. There has been no change to<br />

the overall dose you take each day.<br />

There has been no change to the actual medicine you receive, the only difference is that<br />

it is a tablet rather than a capsule. So there should be no change to the benefit you<br />

receive <strong>from</strong> your current treatment.<br />

You will notice that the tablet is much smaller than the capsule <strong>for</strong>mulation and<br />

there<strong>for</strong>e potentially easier to swallow<br />

If you have any concerns about this change please contact the practice<br />

Practice details<br />

Page 6 of 6

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