Developing a Local Enhanced Service Specification

Community Pharmacy Local Enhanced Service Agreement

Provision of Medicines to Decolonise Methicillin Resistant Staphylococus Aureus (MRSA) - under the terms of a Patient Group Direction.

2010/11

Version: Final v. 21.09.2010

Date Reviewed by LPC: October 2010

Responsible Clinician/Service Lead:

Responsible Commissioning Manager: Julie M Howard

Review date: March 2011

1 COMMUNITY PHARMACY LOCAL ENHANCED SERVICE AGREEMENT 2010/2011

Contents

1 Introduction

2 Background

3 Service Aims

4 Service Outline

5 Eligibility to provide the service

6 Quality & Clinical Governance Standards

7 Information & Data Collection Requirements

8 Performance Management

9 Exit and Suspension Arrangements

10 Activity & Costs

11 References

12 Signatures

2 1 Introduction

All Providers are expected to provide Essential and those Additional services that they are contracted to provide to all their patients. This Local Community Pharmacy Enhanced Service (CPLES) Agreement outlines the more specialised service to be provided. The specification of this service is designed to cover the enhanced aspects of clinical care of the patient, all of which are beyond the scope of Essential Services. No part of the specification by commission, omission or implication defines or redefines Essential or Additional Services.

2 Background

NHS acute trusts have been tasked with the ‘screening of patients on admission, which should include screening of all elective admissions by March 2009’ (DH 2009) and ‘policies should make provision for decontamination procedures for colonised patients, as appropriate;’ (DH 2009).

This service will be targeted at those patients who have been assessed at a pre- admission clinic prior to elective surgery and high risk non-surgical patients following hospitalisation.

Eligible patients will have been pre-screened by staff or have been a patient in the following settings:

Mid Yorkshire Hospitals NHS Trust

 Pinderfield General Hospital  Pontefract General Infirmary  Dewsbury and District Hospital

Community pharmacists via a suite of PGDs will enable previously screened patients, who have received a positive result for MRSA, to obtain their treatment from a community pharmacy setting prior to their elective surgery. Decisions regarding whether the patient should receive dual or triple therapy and which drugs are appropriate will have been made by the referring hospital.

3 Service Aims

The supply of dual therapy in the form of

 Mupirocin 2% nasal ointment,  Octenidine 0.3% wash lotion, 450ml

Only when stipulated for patients having a percutaneous endoscopic gastrostomy (PEG) feeding tube inserted and who have been screened as MRSA positive will triple therapy be supplied by Mid Yorkshires hospitals NHS Trust (as indicated above).

3  Mupirocin 2% nasal ointment,  Octenidine 0.3% wash lotion, 450ml  Chlorhexidine gluconate 0.2% mouthwash

Which will:

a) Support the decolonisation of MRSA in elective surgery patients

b) Support the decolonisation of MRSA in high risk non surgical patients

c) Improve access to treatment for the decolonization of MRSA.

d) Provide advice and support alongside treatment for the decolonization of MRSA.

e) Increase multidisciplinary/multi-sector working when dealing with elective surgery/high risk non-surgical patients

Article I. Service Outline

The pharmacy contractor has a duty to ensure that pharmacists involved in the provision of the service are aware of and operate within local protocols.

Pharmacists who supply and administer medicines under the suite of PGDs must undertake any local training that the PCT may require them to, prior to commencing provision of the service. Training will be delivered by the NHS Wakefield District Infection, Prevention and Control, Team.

Pharmacists who supply and administer medicines under the suite of PGDs must act within their competencies and must sign and retain a copy of the PGDs.

The pharmacy must maintain appropriate records, including a record of the name of the pharmacist providing treatment, patient identifiers and the medicine provided, to ensure effective ongoing service delivery and audit. The return of tear-off slips confirming the patient has been treated will also need to be documented. Records will be confidential and must be stored securely. For adult patients this will mean record retention for two years whilst for paediatric patients records will need to be retained until the child’s twenty fifth birthday.

On occasions pharmacists may need to share relevant information with other health care professionals and agencies, in line with local and national confidentiality and data protection arrangements, including the need for the permission of the person to share the information.

The pharmacy contractor will ensure that pharmacists delivering this service return all claim forms at the end of each month for which the service is provided.

The PCT will provide up to date details of other services to which people that require further assistance can be referred. The information will include the location, hours of opening and services provided by each service provider.

4 Eligibility criteria and referral pathways for this service are agreed locally with the PCT.

The PCT provide a framework for the recording of relevant service information for the purposes of audit and the claiming of payment.

Relevant patient information leaflets will be provided to pharmacies delivering this service by the PCT.

At least one meeting per year will be arranged by the PCT to promote service development and update pharmacy staff with new developments, knowledge and evidence.

The suite of PGDs will contain information as specified in the relevant legislation.

Participating pharmacies must deliver the service from a consultation room which, as a minimum, meets the standards required for the delivery of Medicines Use Reviews as ‘set nationally.’

Participating pharmacies must have a fax machine which is in full working order to enable prompt confirmation of collection of decolonisation treatments with the screening service/s.

Participating pharmacies must notify the commissioner if there are any changes in accreditation.

5 Hours of service and continuity

The service should be provided during the registered core and supplementary hours of the pharmacy.

If this is not possible e.g. in the absence of the accredited pharmacist, the pharmacy staff will signpost the client to another pharmacy that is able to provide the service and should whenever possible phone to check that the services is available at a time suitable to the patient.

Prior to selection for engagement in this service community pharmacies must be capable of delivering all of the essential services of the Community Pharmacy Contract as set out by the National Health Service (Pharmaceutical Regulations) 2005 (Department of Health [DH] 2005).

The pharmacy contractor has a duty to ensure that pharmacists involved in the provision of the service have the relevant knowledge and are appropriately

5 trained in the operation of the service, including sensitive, client-centred communication skills and adequate knowledge of the medical condition for which medicines are being supplied.

7 Stakeholder Engagement & Publicity

The PCT will publicise the contact details of participating pharmacies via a letter sent to patients who have been screened and found to need treatment.

8 Quality & Clinical Governance Standards

The pharmacy has appropriate PCT provided patient literature/health promotion and other material available and a suitable area within the pharmacy for display of these materials. The pharmacy can demonstrate how it actively promotes the uptake of these materials.

The pharmacy has in place a Standard Operating Procedure (SOP) for the supply of medicines via a PGD. The SOP and referral pathways for the service should be reviewed on an annual basis.

The pharmacy contractor can demonstrate that pharmacists involved in the provision of the service have undertaken relevant CPD.

The pharmacy participates in audit of service provision at reasonable intervals determined by the PCT. This will include audit of service user experience.

The pharmacy can demonstrate robust quality assurance for any processes or equipment used.

9 Service Review

This specification is for the financial year 2010/11 and may be reviewed from time to time if appropriate.

Article II. Exit and Suspension Arrangements

Suspension

The scheme will be suspended if at any time the Provider is unable to provide services in line with the eligibility criteria. Before any suspension the Provider and the Commissioner will discuss the reason for the suspension identifying any possible resolution. If the matter is not resolved the PCT will issue a suspension notice to the Provider within 7 days.

6 If for any reason, service provision or patient safety is compromised in any way, the contract will be suspended pending the outcome of a full investigation, following which the agreement will either terminate or be reinstated.

Termination

At the point of review, usually annually, either party is entitled to discontinue the service with three months notice from either side.

Furthermore, both parties may terminate the agreement with immediate effect if there has been a breach of contract or insolvency on either party’s part.

Variation

The service may be varied if the Provider and Wakefield District PCT agree this in writing.

Article III. Activity & Costs

The PCT in agreeing to this enhanced service in no way commit themselves to the capital expenditure or revenue consequences of the equipment necessary for particular procedures covered by this enhanced service.

ITEM PAYMENT

Consultation Fee £15.00 per consultation

Supply of decolonisation medication Reimbursed at Net Ingredient Cost plus VAT Mupirocin 2% nasal ointment £5.80 + 17.5% VAT = £6.82 £5.80 + 20% VAT = £6.96 (ref Jan) Octenidine 0.3% wash lotion, 450ml £3.21 + 17.5% VAT = £3.77 £3.21 + 20% VAT = £3.85 (re Jan)

Payment should be claimed by the Provider(s) on a monthly basis on the claim form/spreadsheet provided by the PCT. All completed forms must be returned no later than the 5th of the following month. The PCT will make payments on a monthly basis and be identifiable as Local Scheme 7.

7 10 References:

DH (2005) The National Health Service (Pharmaceutical Regulations) 2005 London: The Stationary Office

DH (2009) The Health and Social Care Act 2008:Code of Practice for the NHS on the prevention and control of healthcare associated infections and related guidance. London: Crown Copyright

PSNC (2004) NHS Community Pharmacy Contractual Framework: Advanced Service – Medicines Use Review & Prescription Intervention Service Aylesbury: PSNC

Article IV. Signatures

Should the pharmacy wish to provide the Provision of Medicines to Decolonise Methicillin Resistant Staphylococus Aureus (MRSA) - under the terms of a Patient Group Direction Community Pharmacy Local Enhanced Service, please refer to the Enhanced Services Schedule 2010/2011 for signatures.

Please be aware that in signing the enhanced service schedule 2010/2011 the pharmacy/pharmacist is agreeing to undertake all elements of this enhanced service as detailed in this specification.

8 COMMUNITY PHARMACY LOCAL ENHANCED SERVICE AGREEMENT 2010/2011

Parties to the Agreement:

This agreement is made between: and

Wakefield District PCT ……………………………………...

White Rose House ……………………………………...

West Parade ……………………………………..

Wakefield ……………………………………..

WF1 1LT ……………………………………..

Signed on behalf of WDPCT:

______(Signed)

______(Name)

______(Position)

______(Date)

Signed on behalf of the Provider: ______(Signed)

______(Name)

______(Position)

______(Date)

9 ______(OCS Code)

10 AUTHORISATION OF NAMED HEALTH PROFESSIONAL TO SUPPLY OR ADMINISTER MEDICINES UNDER PATIENT GROUP DIRECTIONS

For the Provision of Medicines to Decolonise Methicillin Resistant Staphylococus Aureus (MRSA) by Community Pharmacists

I have read and understood the Patient Group Direction and agree to work within its confines.

Name of Trading Name Pharmacy Address Signature of Pharmacist Date Date CPPE Pharmacist of Pharmacy Training Completed

11 Community Pharmacy MRSA Service - Claim Form

FINANCIAL INVOICE MONTH……………………………………

I declare that the information given on this claim form is true and correct to the best of my knowledge.

I understand that action may be taken against me if I make an incorrect claim and consent to the disclosure of relevant information on this form for the purpose of fraud prevention, detection and investigation.

Pharmacy Trading Name:………………………………………………………. OCS Code: Address:

Post Code:

Pharmacist Name:…………………………………………………………….…….

MRSA Service Total Re-imbursement Amount Claimed (VAT included where Number Costs appropriate @ 17.5%) Consultations £15.00 £0.00

Mupirocin 2% nasal ointment £5.80 £0.00

Octenidine 0.3% wash lotion, 450ml £3.21 £0.00

TOTAL £0.00

OFFICIAL USE ONLY Payment Authorised By: ______

Return completed form to: Julie Howard, Wakefield District Primary Care Trust, White Rose House, West Parade, Wakefield, WF1 1LT, by the 5th of the following month Payments will be shown as local scheme 7 on your monthly statements

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FINANCIAL INVOICE MONTH……………………………………………..

Medication Required for Dual Therapy Patient Name or Identifier or Date Medication Date of Confirmatory FAX Hospital Number Issued / Supplied Mupirocin 2% Nasal Octenidine 0.3% Wash Ointment Lotion, 450ml

Total: Total: 0 0

of 34 13 PATIENT GROUP DIRECTION (PGD) FOR

CHLORHEXIDINE GLUCONATE 0.2% w/v MOUTHWASH GSL to MRSA positive adults identified by screening

YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition

Elimination of oral meticillin resistant staphylococcus aureus Indication (MRSA) as part of the triple therapy decolonisation regime (with Octenisan TM wash lotion & Bactroban TM nasal ointment) for adults found to be MRSA positive after being screened prior to insertion of a percutaneous endoscopic gastrostomy (PEG) feeding tube Inclusion criteria Adult presenting letter stating positive screening for MRSA and requiring MRSA triple therapy decolonisation regime.

Exclusion criteria  History of hypersensitivity to chlorhexidine – such reaction are extremely rare.  Contains alcohol and some patients may wish to avoid the product because of their religious belief. Management of Refer back to originating source of letter excluded patients

Action if patient Refer back to originating source of letter declines

Drug Details

Name, form and CHLORHEXIDINE GLUCONATE 0.2% w/v MOUTHWASH strength of medicine Legal status GSL Route/Method Mouthwash

Dosage Use 10ml of mouthwash solution Frequency of dose Patients require treatment twice daily for 5 days proir to surgical procedure Date approved: August 2009 Ref: 09/01 Next review date: August 2011 Page 14 of 34

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PATIENT GROUP DIRECTION (PGD) FOR

Duration of 5 days treatment Maximum or 1 decolonisation regime per litre presented minimum treatment period Quantity to supply 300ml overlabelled with pharmacy/patient/product name, date of supply and treatment instructions Discolouration: A superficial discolouration of the upper side of Common side effects the tongue may occur. This disappears after treatment is discontinued. Brown staining of the teeth and silicate or composite restorations may also occur. This is reversible and can be prevented by brushing with toothpaste daily before using the mouthwash or, in the case of dentures, cleaning with a conventional denture cleaner. Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continuous use. Oral desquamation: In cases where oral desquamation occurs, dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash. Parotid gland swelling: very occasionally, swelling of the parotid gland during the use of chlorhexidine mouth rinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment. Skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur. Generalised allergic reactions to chlorhexidine have also reported but are extremely rare. Records  Record on patient’s PMR  Notify originating source of the letter that patient has been supplied the treatment (by fax)  Monthly data set Date approved: August 2009 Ref: 09/01 Next review date: August 2011

of 34 15 Page 2 of 34 Version 1.1

Advice to Patients  Provide a copy of the trust leaflet ‘MRSA decolonisation regime in adults & children’  Inform patient of the rationale for use of the mouthwash as part of the MRSA decolonisation regime for patients undergoing PEG insertion  Reassure patient regarding positive screening result for MRSA  Inform the patient how to use the mouthwash, frequency and duration and when to commence treatment  Dentures should be cleaned and soaked in mouthwash for 15 minutes.  Refer patient/carer to the product leaflet and give verbal re-enforcement if necessary

Date approved: August 2009 Ref: 09/01 Next review date: August 2011

Staff Characteristics Pharmacist registered with the Royal Pharmaceutical Qualifications Society of Great Britain (MRPharmS)

NHS Wakefield District approved MRSA decolonisation training Additional requirements Maintenance of own level of updating with evidence of Continued training continued professional development (RPSGB requirements) requirements

Referral Arrangements and Audit Trail

Referral Refer to originating source of letter arrangements Audit trail  Patient’s community pharmacy PMR  Advice given to parent (including side effects)  Name of pharmacist supplying the treatment  Details of any adverse drug reaction and actions taken including documentation on the patient’s medical record  Return of confirmation of supply of treatment to originating source of letter

References  MYHT PGDs for MRSA decolonisation January 2009  BNF 56

Organisation NHS Wakefield District

Authorisation

This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting

Date approved: August 2009 Ref: 09/01 Next review date: August 2011 Page 6 of 34

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Patient Group Direction Peer Reviewed by

Name Position Date

Individual Authorisation

PGDS DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY.

It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct.

Each professional should be provided with an individual copy of the clinical content of the PGD and a photocopy of this page showing their authorisation should be forwarded to their line manager to be kept in their personal file.

I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD.

Name of Signature Date Professional

Date approved: August 2009 Ref: 09/01 Next review date: August 2011 Page 7 of 34 Version 1.1

OCTENIDINE 0.3% WASH LOTION GSL

to MRSA positive adults identified by screening YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition

 Elimination of oral meticillin resistant staphylococcus Indication aureus (MRSA) as part of the dual therapy decolonisation regime (with Bactroban TM nasal ointment) for adults found to be MRSA positive after being screened  MRSA decolonisation in adults as part of the triple therapy decolonisation regime (with Bactroban TM nasal ointment & chlorhexidine mouthwash) for patients having a percutaneous endoscopic gastrostomy (PEG) feeding tube inserted and who have been screened as MRSA positive Inclusion criteria Adult presenting letter stating positive screening for MRSA and requiring MRSA dual or triple therapy decolonisation regime.

Exclusion criteria  History of hypersensitivity to octenidine, cocamidopropylamine, PEG-7, glyceryl cocoate, glycerine, hydroxyethylcellulose, lactic acid or allantoin.  Pregnancy or breast feeding Management of Refer back to originating source of letter excluded patients

Action if patient Refer back to originating source of letter declines Drug Details

Name, form and OCTENIDINE 0.3% WASH LOTION (Octenisan TM) strength of medicine Legal status GSL Route/Method For washing, apply Octenisan to a damp washcloth, rub onto the areas of the body to be cleansed (contact time: Date approved: August 2009 Ref: 09/02 Next review date: August 2011 Page 1 of 34 Version 1.1

to MRSA positive adults identified by screening

3 minutes). Rinse off and dry with a clean towel.  For hair washing. Use octenisan in the same way as normal preparartions, again allowing 3 minutes contact time, Rinse off and dry.

Dosage A sufficient amount o undiluted Octenisan TM

Frequency of dose Patients require treatment once daily for 5 days prior to surgical procedure Hair should be washed on day two and day four of the decolonisation regime. Duration of 5 days treatment Maximum or 1 decolonisation regime per litre presented minimum treatment period Quantity to supply 450ml over labelled with pharmacy/patient/product name, date of supply and treatment instructions Octenisan is reported to be excellent for all skin types; including Common side effects skin prone to allergy and even cases of hypersensitivity to soap. There are no reported side-effects.

Records  Record on patient’s PMR  Notify the originating source of letter that patient has been supplied the treatment (by fax)  Monthly data set

Advice to Patients  Provide a copy of the Trust leaflet ‘MRSA decolonisation regime in adults & children’  Inform the patient how to apply the wash lotion, paying particular attention to armpits, bellybutton, groin and perineum (area of skin around the bottom). Frequency and duration and when to commence treatment.  The patient should ensure that they are the sole user of the washcloth and towel or that these are disposable  The face cloth and towel to be single use or cleaned and dried after each shower or bath.  Seek help from carer if it is difficult to follow the procedure.  Refer patient/carer to the product leaflet and give verbal re-enforcement if necessary.

Authorisation

Name Position Date

MUPIROCIN 2%w/w NASAL OINTMENT POM

to MRSA positive adults identified by screening YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition

 Elimination of oral meticillin resistant Indication staphylococcus aureus (MRSA) as part of the dual therapy decolonisation regime (with Octenisan TM wash lotion) for adults found to be MRSA positive after being screened  MRSA decolonisation in adults as part of the triple therapy decolonisation regime (with Octenisan TM wash lotion & chlorhexidine mouthwash) for patients having a percutaneous endoscopic gastrostomy (PEG) feeding tube inserted and who have been screened as MRSA positive Inclusion criteria Adult presenting letter stating positive screening for MRSA and requiring MRSA dual or triple therapy decolonisation regime. Exclusion criteria  History of hypersensitivity to Bactroban TM (mupirocin), white soft paraffin or Softisan 649 (a glycerine ester).  Pregnancy or breast feeding Management of excluded Refer back to originating source of letter patients Action if patient declines Refer back to originating source of letter

Drug Details

Name, form and MUPIROCIN 2%w/w NASAL OINTMENT (Bactroban TM) strength of medicine Legal status Prescription Only Medicine (POM) Route/Method A small amount of the ointment about the size of a match-head is applied to the inside of each nostril. The nostrils are closed by Date approved: August 2009 Ref: 09/03 Next review date: August 2011 Page 1 of 34 Version 1.1

pressing the sides of the nose together; this will spread the ointment throughout the nares. Dosage A small amount of the ointment, about the size of a match head, is applied to the inside of each nostril. Frequency of dose Three times a day (8 hourly) for five days prior to surgical procedure In the event of a missed dose, administer the dose as soon as remembered; do not apply two doses within an hour of each other Duration of 5 days treatment Maximum or 1 decolonisation regime per litre presented minimum treatment period Quantity to supply 3g overlabelled with pharmacy/patient/product name, date of supply and treatment instructions  Uncommon side effects affecting 1 in 100 – 1 in 1,000 Common side effects people including: itching, redness, burning, tingling or stinging of the nose where the ointment has been used.  Very rare side effects affecting less than 1 in 10,000 people including: rash. Itchiness, redness or soreness of the skin on the hands, face or body.

Wash the affected area and ask patient to inform GP or pharmacist is adverse effects develop Records  Record on patient’s PMR  Notify MYHT that patient has been supplied the treatment Special  Record on the patient’s PMR considerations/  Notify the originating source of letter that patient has been Advice for Patient supplied the treatment (by fax)

 Monthly data set Date approved: August 2009 Ref: 09/03 Next review date: August 2011 Page 2 of 34 Version 1.1

Advice to Patients  Provide a copy of the trust leaflet ‘MRSA decolonisation regime in adults & children’  Inform the patient how to apply the ointment, frequency and duration and when to commence treatment.  Refer patient/carer to product leaflet and give verbal re- enforcement if necessary.

Authorisation

Name Position Date

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