Newham NHS

Local Enhanced Service

Methadone and Buprenorphine Supervised Administration Service

SERVICE LEVEL AGREEMENT 2010 - 11

PLEASE INSERT PHARMACY STAMP HERE (if available)

CONTENTS

  • Summary of Scheme
  • Financial Details
  • Signature Sheet
  • Service Aims
  • Service Criteria
  • Ongoing Measurement & Evaluation

Appendices

  • Appendix 1 - Audit
  • Appendix 2 - Supervised Methadone Guidelines
  • Appendix 3 – Definition of stability
  • Appendix 4 - Information for travellers
  • Appendix 5 - Example of a terms of Agreement for Supervised Administration
  • Appendix 6 - Claim form and Patient Acceptance form

SUMMARY OF SCHEME

  • This service is commissioned by NHS Newham on behalf of the Newham Drug Action Team (DAT)
  • This service will require the pharmacist to supervise the consumption of methadone or buprenorphine at the point of dispensing in the pharmacy, ensuring that the dose has been administered to the patient.
  • The service will be provided by the pharmacy according to a written Standard Operating Procedure.
  • Pharmacies will offer a user-friendly, non-judgmental, client-centred and confidential service.
  • The pharmacy will provide support and advice to the patient, and liase with primary care or specialist centres where appropriate.
  • The service will be monitored by the PCT with the support of the Drug Action Team (DAT) and shared care monitoring group (SCMG).
  • The Shared Care Manager will manage the budget for the scheme and the PCT will make the payments to the Contractor against the invoices required to be submitted on a monthly basis with evidential paperwork (Prescription monitoring form and claim form).

Provision of Enhanced Services

This enhanced service will only be commissioned from pharmacies fulfilling the full range of Essential Services as defined by the Pharmacy Contractual agreement and operate a minimum 6-day opening policy. Exceptions to the minimum 6-day opening policy will only be considered when there is no pharmacy available locally that the client can access. Approval must be gained from the DAT and prescribing team for individual clients.

FINANCIAL DETAILS

Fee per Supervised Dose of Methadone £2.20

Fee per Supervised Dose of Buprenorphine £2.50

It is expected that newly participating pharmacies audit their existing service provision and make any necessary changes to meet the requirements of the service specification.

No cost is included for Hepatitis B vaccination as the consensus is that the risk can be managed without it.

Agreement Period

The agreement will commence on 1st February 2010 until 31st March 2011. It will be subject to renewal if agreed by all parties.

The agreement may be terminated without penalty if the PCT or the Pharmacy gives the other party at least one month’s notice in writing.

N.B. The PCT reserves the right to withdraw this enhanced service immediately if the pharmacy is found not to be meeting its requirements for the provision of essential services after the SLA has commenced.

SIGNATURE SHEET

METHADONE SUPERVISED ADMINISTRATION SERVICE

This document constitutes the agreement between the pharmacy and the PCT in regards to this enhanced service.

YES / NO

This pharmacy currently provides the service

Those pharmacies who have not previously provided the service will need to receive approval from the Shared Care Manager/SCMG in conjunction with the PCT before commencing with the service.

Signature on behalf of the Pharmacy Contractor:

On behalf of the pharmacy I confirm that the information detailed within this service level agreement is accurate and reflects how the pharmacy approaches the provision of this service. In addition I confirm that the pharmacy will comply with the data reporting and audit requirements of the scheme. I will abide by all terms of the Service Level Agreement

Signature / Name / Date
Pharmacy Name & Address

Signature on behalf of the PCT:

Signature / Date / Name
Payment Will Only Be Made Upon Receipt of Pharmacy Signature Sheet

If you have any queries relating to this service level agreement, please contact –

Emma Richardson – Substance Misuse Manager

NHS Newham

Warehouse K, 2 Western Gateway

London E16 1DR

Tel – 020 70596546 –

Pharmacy: Please keep a copy for your records

SERVICE AIMS

To ensure compliance with the agreed treatment plan (prescription) by:

  • Dispensing in specified instalments (doses may be dispensed for the patient to take away to cover days when the pharmacy is closed),
  • Ensuring each supervised dose is consumed by the patient for whom it is intended.

To reduce the risk to local communities of:

  • Diversion of methadone onto the illicit drugs market; and
  • Accidental exposure to methadone.

To provide service users with regular contact with health care professionals and to help them access further advice or assistance. The service user will be referred to specialist treatment centres or other health and social care professionals where appropriate.

SERVICE CRITERIA

The specification details the following service criteria. The following pages contain some further guidance from the PCT on expected processes, outcomes and deliverables based on this process.

1)Service Outline

2)Staffing

3)Records/Audits

4)Quality Indicators

Criteria One: Service Outline
Details
  • This enhanced service must be provided throughout the pharmacy’s opening hours although it is recognised that some restriction at the beginning or end of the day may be necessary.
  • The part of the pharmacy used for provision of the service will provide a sufficient level of privacy and safety.
  • The pharmacy will present the medicine to the service user in a labelled dispensing container which could be used as a suitable single use receptacle and will provide the service user with water to facilitate administration and/or reduce the risk of doses being held in the mouth.
Pharmacy Plan For 2010-11
Criteria Two: Staffing
Details
  • The pharmacy contractor will ensure that pharmacists, locums and staff involved in the provision of the service have relevant knowledge and are appropriately trained in the operation of the service.
  • The pharmacy contractor will ensure that pharmacists and staff involved in the provision of the service are aware of and operate within local protocols.
  • The PCT and DAT will provide details of relevant referral points which pharmacy staff can use to signpost service users who require further assistance.
  • The PCT and DAT will obtain or produce health promotion material relevant to the service users and make this available to pharmacies
Pharmacy Plan For 2010-11
Criteria Three: Records/Audits
Details
  • The pharmacy will maintain appropriate records to ensure effective ongoing service delivery and audit. A record of each client will be maintained on a patient medication record (PMR) at the pharmacy.
  • A new patient acceptance form is completed and sent to the PCT for every new patient receiving the service from the pharmacy within 7 days.
  • Pharmacist will ensure patients sign they have received supervised dose
  • Pharmacists will share relevant information with other health care professionals and agencies, in line with confidentiality arrangements. (patients signed confidentiality form should be provided in initial documentation provided to the pharmacy by the prescribing organisation)
  • Pharmacists will record relevant service information for the purposes of audit using the framework provided the PCT in conjunction with the DAT (appendix 1).
  • The pharmacy participates in an annual audit of the service requested by the PCT in conjunction with the DAT in liaison with the LPC. The results of this audit are reviewed by the PCT/DAT annually.
Pharmacy Plan For 2010-11
Criteria Four: Quality Indicators
Details
  • The pharmacy has appropriate health promotion material (available for the user group and promotes its uptake). This information will be agreed by the PCT and DAT.
  • The pharmacy reviews its standard operating procedures and the referral pathways for the service where necessary or at least on an annual basis.
  • The pharmacy can demonstrate that pharmacists and staff involved in the provision of the service have undertaken CPD relevant to this service.
  • The pharmacy participates with any audit of service provision agreed by the Shared Care Monitoring Group in conjunction with the DAT and the PCT and completes the audit in Appendix 2 at least annually.
  • The pharmacy co-operates with any locally agreed PCT in conjunction with the DAT-led assessment of service user experience.
  • The pharmacy will distribute patient experience questionnaires when requested by the PCT.
  • Any Serious Untoward incident (SUI) or critical incident will be reported to the medical director of the PCT, whereby the incident and learning outcomes will be discussed at the performance meetings.
Pharmacy Plan For 2010-11
ONGOING MEASUREMENT AND EVALUATION

1)The pharmacy is required to agree with the PCT this service specification/plan at the start of the year.

2)The specific data measurement, evaluation and audit requirements of the scheme are outlined in the individual sections of this document

3)The pharmacy will be required to collate the necessary evidence of compliance with the requirements of the scheme.

4)The scheme will then be evaluated at the annual contract review with the PCT.

APPENDIX 1

Audit of Service

Service Standard /
Rating
/ Action plan for improvement
Always / Mostly / Never
1 / Where a new service user presents without prior notification by the prescriber, contact is made with the prescriber to confirm the client’s identity and prescription details before issuing the first dose.
2 / An agreement on the “conduct of behaviour” should be explained and two copies signed by each new service user (one for them to keep and one to be kept in the pharmacy). See Appendix 5
3 / A signed copy of any agreement is held securely in the pharmacy for 11 Years.
4 / Service users are given a practice leaflet and information about appropriate times to collect doses if available
5 / Information is given to service users relating to weekend and Bank Holiday doses, if available
6 / Service users are introduced to staff so that they can be identified and dealt with promptly each day
7 / The pharmacy must have a method to confirm identification if the service user cannot be identified by staff e.g. PMR ID card or check signature against agreement
8 / The service user's PMR should be complete and include name and address, date of birth, GP/prescriber details, key worker name and contact details (if applicable) and “supervised consumption” or similar note
9 / The service user's PMR should also include all other prescription items dispensed by the pharmacy, and where appropriate, other over-the counter medication supplied.
10 / All patient identifiable information is kept in a secure place and is not passed on to anyone other than those authorised to see it.
11 / Prescriptions must be legally correct
12 / The methadone mixture used is a licensed product or is extemporaneously prepared according to an SOP in line with RPSGB guidance
13 / Any equipment used in the manufacture or dispensing of methadone mixture should be cleaned, calibrated and serviced regularly according to manufacturers instructions
14 / Sugar and/or colour free preparations should only be dispensed if they are specifically prescribed as they have a greater potential for abuse
15 / If doses are prepared in advance (recommended if space in the CD cabinet permits) they should be suitably labelled and stored in the CD cabinet
16 / Individual instalments are fully dispensed and labelled prior to supervision
17 / Doses are measured and checked before being dispensed into a suitable container
18 / The dispensing label should be attached to the container detailing name, directions, quantity and date of dispensing
19 / Take home doses are provided in an appropriate leak proof container and fitted with child resistant closures
20 / Advice is given on safe storage of take home doses as necessary “Keep out of reach of children”
21 / The right hand side of the prescription is marked with the date and quantity dispensed and initialled when the service user has consumed the dose or when any "take home" doses have been supplied
22 / If the service user does not collect a dose the prescription is marked "Not Collected" and the PMR record reflects this
23 / If the service user fails to collect three consecutive doses the prescription is suspended (NOT CANCELLED) until the prescriber has been contacted and an assessment has been made as their tolerance may have fallen
24 / If a service user is intoxicated the dose is not dispensed until the service user has “sobered up” and the clinic informed. Professional discretion should be used on Saturday for take home doses
25 / If a dose is to be collected by a third party this should be stated on the prescription or a verbal authorisation from the prescriber and written authorisation from the client (retained for 1 year) is required on each occasion.
26 / Supervision takes place in a quiet area with sufficient privacy to allow both service user and pharmacy staff member to feel comfortable, i.e. consultation room or away from main area (Supervision does not take place in the dispensary)
27 / Doses should be presented to the patient in a single use disposable receptacle
28 / Confidentiality is protected by removing identifiable labels from containers prior to disposal or by obliterating names using permanent marker
29 / A drink of water is provided to the service user in a single use disposable receptacle
30 / The staff member supervising the dose should be satisfied that the dose has actually been swallowed by observing water being swallowed after the dose, or by conversing with the service user
31 / Any receptacles which the service user has been in contact with should not be reused and should be disposed of in the normal waste. Pharmacy staff should avoid handling the used containers.
32 / Harm minimisation information has been reviewed and steps taken to minimise any risks to pharmacy staff.
33 / Entries are made in the CD register in chronological order on the day the dose was collected (recommended) or the day following
34 / The CD entry is marked clearly to indicate a supervised dose (‘S’ in the margin) or unsupervised dose (‘X’ in the margin) to provide an audit trail. (To be reviewed in-line with availability of electronic CD registers)
35 / Claim form is fully completed and submitted by the 8th of each month (See appendix 3)
36 / The pharmacy makes use of health promotion materials relevant to the service users e.g. harm reduction information supplied by the PCT.
37 / The pharmacy makes use of signposting information provided by the PCT or DAT
38 / The pharmacy reviews its standard operating procedures and the referral pathways for the service where necessary or at least on an annual basis
39 / The pharmacy completes this audit at least annually and submits copies as requested for collation and review by the DAT
40 / The Pharmacy Contractor ensures the quality of the service is maintained by all pharmacists, locums and staff involved in its provision.
41 / The pharmacists and staff involved in the provision of the service have undertaken CPD relevant to the service and are able to demonstrate this if requested by the PCT/DAT (CPPE or RCGP part 1)
42 / The pharmacist will complete a new patient acceptance form for each new client receiving Methadone or Buprenorphine at the pharamcy
43 / The pharmacist will record all supervisions on the supervised consumption recording form
44 / The client will sign that they have received their supervised dose after each supervision

APPENDIX 2

Guidelines For Supervised Consumption Of Methadone.

1. Introduction.

1.1. The purpose of these guidelines is to provide local guidelines for Newham for supervised consumption that are consistent with “Drug Misuse and Dependence – Guidelines on Clinical Management”, (published in 1999 and revised in 2007, and known as the “Orange Book”).

1.2. The relevant guidance on supervised consumption (p50 Chapter 5 section 5.4.1) is as follows:

1.3.1 Supervised consumption with an appropriate professional provides the best guarantee that the drug is being taken as directed.

-In most cases, all new patients being prescribed methadone or buprenorphine should be required to take their daily dose under the direct supervision of a professional for a period of time which may, depending on the individual patient, be at least 3 months, subject to compliance

-Similarly, when the patient re-starts methadone after a break, or receives a significant increase in the methadone dose, daily dispensing, ideally with supervised consumption, should be reinstated for a period of time agreed in local guidelines and protocols

-These arrangements should only be relaxed, so as to allow take-home doses; if the doctor can be satisfied that compliance will be maintained. The relaxation of supervision can be seen as an important component of rehabilitation and re-establishing acceptable responsible behaviour and should be taken after consultation between the patient, doctor pharmacist and shared care worker.

-Arrangements for daily dispensing through instalment prescribing and where appropriate, supervised consumption of other drugs, should also be made

Take-home doses should not be prescribed where:

-The patient shows a continued and unstable, or unauthorised, pattern of drug misuse, including a significant increase in alcohol intake, the use of illicit drugs, benzodiazepines or other tranquillisers

-The patient has a significant unstable psychiatric illness

-There is continuing concern that the prescribed drug is being diverted or used inappropriately

1.4. The use of supervised consumption has had important benefits in reducing the misuse of methadone and supervised consumption has benefits for patients by providing some routine and structure.

1.5. GPs may move patients off supervised consumption provided they comply with the guidance issued in the orange book. One of the purposes of drug treatment is to move drug users towards positive changes in their lives. For this to happen they will have to develop responsibility, self-respect and integrate back into the community. In particular the Orange book suggests that this may be considered where the advantages of supervised consumption are outweighed by the benefits of “rehabilitation and re-establishing acceptable responsible behaviour”. Particular examples are where supervised consumption is interfering with childcare, employment or training opportunities.