SUTTON PHARMACY SUPERVISED CONSUMPTION

AND NEEDLE EXCHANGE SCHEME

SERVICE LEVEL AGREEMENTS

1

Service Level Agreements (SLAs)Included in this document are Service Level Agreements for the provision of:

Supervised consumption of prescribed Medicines Needle exchange services

There are to be administered by community pharmacies for the benefit of drug users within the London Borough of Sutton for the INSPIRE Partnership.

The parties to the SLAs for these services are:

1. Cranstoun a company incorporated in England and Wales under company number 03306337 and whose registered office is at Cranstoun Central Office, Thames Mews, Portsmouth Road, Esher, Surrey KT10 9AD (The lead contractor in the INSPIRE Partnership) and

2. The participating pharmacy.

There are separate agreements for each service and a participating pharmacy may apply to provide either:

Supervised consumption services as a single intervention (Section A) Or Needle exchange services as a single intervention (Section B) Or Both services in tandem (Sections A & B).

2

Contents:SECTION A – SLA SUPERVISED CONSUMPTION1. Service Description2. Service Aims and Intended Service Outcomes3. Service Location4. Level of Provision5. Service Standards6. INSPIRE Partnership Responsibilities7. Service Monitoring8. Provision for Disruption of Service9. Reimbursement10. Duration of Agreement11. Termination of Agreement12. Dispute Resolution13. Operational Points of Contact14. References and Bibliography15. Prime Contract16. Signatures and Dates Appendix 1: Community Pharmacy Responsibilities - Supervised Consumption SchemeAppendix 2 Client Contract for Supervised ConsumptionSECTION B – SLA NEEDLE EXCHANGE1. Service Description2. Service Aims and objectives3. Service Location4. Level of Provision5. Service Standards6. INSPIRE Partnership responsibilities7. Service Monitoring8. Provision for Disruption of Service9. Reimbursement10. Duration of agreement11. Termination of Agreement12. Dispute Resolution13. Operational Points of Contact14. Signatures and Dates15. Prime ContractAppendix 1: Service specification

3

SECTION A –

SLA SUPERVISED CONSUMPTION

1. Service Description

1.1 This service will require the pharmacist to supervise the whole process of consumption of prescribed medicines at the point of dispensing in the pharmacy, ensuring that the correct dose has been administered to the patient.

1.2 Pharmacies will offer a user-friendly, non-judgmental, client-centered and confidential service.

1.3 The pharmacy will provide support and advice to the patient, including referral to primary care or specialist centres where appropriate.

2. Service Aims and Intended Service Outcomes

2.1 To provide a service to treatment users and providers which will help to ensure that prescribed methadone / buphrenorphine (as Subutex/Suboxone ®) is consumed under professional supervision when required and that appropriate information is recorded.

2.2 To ensure compliance with the agreed treatment plan by:

Dispensing in specified installments

Ensuring each supervised dose is correctly consumed by the patient for whom it was intended.

2.3 To reduce the risk to the local communities of:

Over usage or under usage of medicines

Diversion of prescribed medicines onto the illicit drugs market

Accidental exposure to the supervised medicines.

2.4 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.

3. Service Location

To ensure that good client access to these services, selected community pharmacies in Sutton will be given the opportunity to provide this service. The INSPIRE Partnership intends to maximize the spread across Sutton and encourages pharmacies participation in this scheme.

4

4. Level of Provision

The pharmacy will agree to provide the prescribed dose of methadone / buprenorphine (as Subutex/Suboxone®) for daily consumption on pharmacy premises for a minimum of 6 days a week (Monday to Saturday ~ excluding Bank Holidays). Prescribed doses for Sundays (and Bank Holidays) will be dispensed on the previous day in a standard container to take away, as required by the Medicines Act.

5. Service Standards

5.1 The requirements of the Medicines Act and the Community Pharmacy Contract apply as usual.

5.2 Pharmacies, designated pharmacists and other staff must be able to demonstrate, on request, that specified accreditation requirements and service standards are achieved and maintained in order to be eligible to participate or to continue in this Scheme.

5.3 Community pharmacies will undertake to provide the supervised consumption service in accordance with their responsibilities as detailed in Appendix 1.

5.4 Note that it is not considered good practice to allow clients known to be prescribed treatment for supervised consumption to collect prescribed medicines on behalf of other clients.

5.5 Pharmacies will be operating to appropriate standards of clinical governance as detailed in Essential Service 8 of the Community Pharmacy Contractual Framework (2005). Pharmacy contractors are also required to comply with the appropriate Standards for Better Health and be able to provide suitable evidence of such to the INSPIRE Partnership. Monitoring against these standards will seek assurance of quality of service delivery applicable to enhanced services such as provision of the supervised consumption of prescribed medicines for drug users.

5.6 The designated pharmacist has a duty to ensure that pharmacists and staff involved in the provision of the service:

Are aware of and operate within local protocols (including the contents of this SLA)

Have relevant knowledge and are appropriately trained in the operation of the service.

5.7 Service protocols should reflect national guidelines and local child and vulnerable adult protection guidelines

5.8 Appropriate records will be maintained to ensure effective ongoing service delivery and audit. Records will be confidential and should be stored securely and for a length of time in line with NHS record retention policies.

5.9 Pharmacies should be mindful of the need to protect patient confidentiality. It is well recognised that there is an obligation to share information between professionals and agencies to ensure that appropriate services are provided and safe working practices are adopted. Information is shared in line with good Information Governance practice including, where appropriate, the need for the permission of the client, or other appropriate authorisation (e.g. Section 38 authority

5

for police) to share the information.

5.10Incident Reporting

The pharmacy will undertake to complete an incident report, as appropriate, for every incident occurring during the provision of the supervised consumption service. All incidents involving a controlled drug must be reported to the INSPiRE Partnership in addition to any other reporting requirements placed on pharmacies.

An incident is defined as any occurrence that is not consistent with the professional standards of care of the patient or routine operation/policies of the organisation.

5.11Accreditation requirements

Participating pharmacies must have a designated named pharmacist, agreed by the INSPIRE Partnership, who will have the clinical responsibility for dispensing and supervision arrangements, ensuring necessary procedures for accuracy and safety are in place. The designated pharmacist must ensure that appropriate arrangements are in place to minimise risk to clients, provider, pharmacy staff and other patients and customers. It is essential to have a Standard Operating Procedure (SOP) in place.

Supervision should take place in a designated area offering suitable privacy for the client, other customers and the general public. Supervision must never take place in the dispensary.

5.12Education and Training

Participating community pharmacies must ensure that a designated Pharmacist attends the required two training sessions per annum. (Training will cover issues such as Harm Reduction, Safeguarding, the operations of NEO and Blood Borne Viruses). Failure to attend may result in payments being delayed. Persistent failure to attend will result in the pharmacy’s ongoing participation in the scheme being reviewed.

It is the responsibility of the designated pharmacist to be assured that all staff (including support staff and locum pharmacists) are adequately trained to meet the requirements of the service at all times.

Additional service criteria

The participating pharmacies as service providers must participate in any annual review, audit and/or training update on request as defined by the INSPIRE Partnership.

6

6. INSPiRE Partnership Responsibilities

6.1 The INSPIRE Partnership will:

Provide a named contact for any queries concerning the scheme

Arrange provision of at least one contractor update opportunity per year (not necessarily face to face) to promote service development and update pharmacy staff with new developments

Provide a suitable framework for the recording of relevant service information for the purposes of audit/ monitoring and the claiming of payment

Ensure arrangements are in place to process payments accurately and efficiently

Provide up to date details of other services which pharmacy staff can use for signposting

Plan and provide any annual audit/review and training update or reaccreditation process for the service as required.

7. Service Monitoring

7.1 The performance of the Supervised Consumption Scheme will be subject to performance monitoring. This may include self-assessments and/or short pharmacy visits as appropriate.

Service Quality Indicators

As a minimum the pharmacy must

Maintain accurate records (as described in Appendix 1).

Review the currency of standard operating procedures and the referral pathways for the service on an annual basis.

Be able to demonstrate that pharmacists and staff involved in the provision of the service have undertaken CPD relevant to this service.

Maintain stocks of INSPIRE Partnership health promotional material available for the user group and promote its uptake.

Participate in any annual review of service provision as defined by the INSPIRE Partnership, including any updated developments.

Co-operate in any INSPIRE led assessment of service user experiences.

Complete an incident report, as appropriate for any incident occurring during the provision of the supervised consumption service and submit to the INSPIRE within 24 hours as appropriate.

The pharmacy must make available records of compliance with the service standards and quality indicators on request by the INSPIRE Partnership.

8. Provision for Disruption of Service7

8.1 Information outlining the process of the service must be cascaded to other pharmacy staff. IMPORTANT NOTE: - Pharmacies should inform the INSPIRE Partnership as soon as possible in situations where a designated pharmacist will no longer be able to retain responsibility for the SLA operating in a given accredited pharmacy, to enable transfer of designated pharmacist status or termination of the agreement (see section 11).

9. Reimbursement

Each Participating Pharmacy will receive £2.00 for each supervised consumption of Methadone, or Physeptone

Each Participating Pharmacy will receive £2.00 for each supervised consumption of Buprenorphine, Subutex or Suboxone.

Community Pharmacies should submit dispensing activity on the NEO System by the 8th of the month for the previous month to allow the INSPIRE Partnership to process payment accordingly. Claims should usually be made within 1 month of the prescription start date.

Invoices for payment will be generated by the NEO system. These will be raised around 8th of each month and verified by Cranstoun in a timely fashion and paid, whenever possible, within 30 days of verification. Undue delay in in verifying an invoice will not to be sufficient justification for failing to regard an invoice as valid and undisputed.

10. Duration of Agreement

This SLA will become operational from 1st April 2018 and will be reviewed annually, unless any major service alterations are required before this date. The agreement will automatically terminate on 31st March 2021.

11. Termination of Agreement

Any pharmacy wishing to terminate this agreement must give 3 months’ notice prior to termination to allow the services to respond and not disadvantage clients. Notice of termination must be written and submitted to the INSPIRE Partnership nominated operational contact. The latter will ensure that all relevant parties are informed.

The INSPIRE Partnership may also terminate this agreement with 3 months written notice, or less should circumstances arise in which the pharmacy is ineligible to continue, i.e., the INSPIRE Partnership may terminate this agreement with immediate effect if the pharmacy is without a designated pharmacist for the service and an interim agreement has not been authorized or if there are on-going performance concerns.

The agreement will also terminate immediately should LB Sutton withdraw consent for the pharmacy to be appointed to deliver service for the INSPIRE service (see 15.2)

12. Dispute Resolution

Dispute resolution will follow appropriate INSPIRE Partnership policies and procedures.

13. Operational Point of Contact8

Darren Nicholas – Borough ManagerINSPIRETel: 07917642644 Email: dnicholas@inspirepartnership.org.uk

14. References and Bibliography

1. The Orange Book – Drug Misuse and Dependence- Guidelines on Clinical Management. Department of Health 2007

2. Medicines, Ethics and Practice A Guide for Pharmacists Version 28, RPSGB July 2004

3. PSNC NHS Community Pharmacy Contractual Framework Enhanced Service – Supervised Administration (Consumption of Prescribed Medicines) Version 1, September 2005

4. NHS Litigation Authority Review ISSUE 25 2002/3

5. The Harmonisation and Accreditation Group (HAG) Competencies and Training Framework for the Supervised Administrations of Medicines for Substance Misusers, Version 1 (Feb 2007)

Additional resources used in preparation of the Appendices for the original

Guidance for the use of buprenorphine for the treatment of opioid dependence in primary care. RCGP/SMMGP 2004

Methadone dose and Methadone maintenance treatment. NTA Research into practice: 3 May 2004

Schering-Plough. Subutex/Suboxone® Summary of Product Characteristics

9

15. Prime Contract

15.1 This Service Level Agreement is made with reference to a contract to provide Public Health Services - Substance Misuse and Associated Service dated 1st April 2016 between Cranstoun and The Mayor and Burgesses of The London Borough of Sutton (the Prime Contract) annexed hereto. In entering into this agreement to provide Supervised Consumption and/or Needle Exchange Services the Pharmacy acknowledges that it agrees to be bound by, and undertakes to Cranstoun to comply with, all the terms of the Prime Contract which do not apply exclusively to Cranstoun, and as further defined and agreed in this Agreement, so that the Cranstoun is able to fulfill its obligations to the Council under the Prime Contract. In the event of any conflict arising between the terms of this Agreement and those of the Prime Contract, the terms of the Prime Contract shall prevail.

15.2 Cranstoun must provide details of the community pharmacies being used for the INSPIRE service to the LB Sutton (including details of ownership and manner in which the organisation is structured e.g. sole trader, partnership or limited company) prior to entering any agreement. The LB Sutton must consent to appointment of each pharmacy and the appointment is therefore subject to the ongoing consent of LB Sutton.

16. Signatories to the Agreement

I hereby declare that Sutton Pharmacy Surrey, operating from 86 Westmead Rd, Sutton SM1 4HY (Registered Pharmacy premises) agrees to participate in the supervised consumption scheme for Methadone and Buprenorphine (as Subutex/Suboxone®) in accordance with the terms outlined above.

Signature on behalf of the Pharmacy Owner/ Representative:

Signature: Name:Organisation:Date:Job Title:Designated named pharmacist (if different from above)

Signature on behalf of Cranstoun:

Signature:Name:Position:Date:

Issued: 1st April 2018Review Date: 31st March 2021

10

Appendix 1

Community Pharmacy Responsibilities - Supervised Consumption Scheme

1. General Responsibilities

It is essential to have in place a suitable Standard Operating Procedure (SOP) to cover all processes involved in delivery of the scheme. Company policies are acceptable where they reflect the principles of the scheme. The SOPs should be readily available to all members of staff and in particular Locum staff.

To only accept clients for supervised consumption who have been appropriately referred by the treatment provider. The initial prescription will be brought to you by the client at an approximate time previously communicated via their key worker (timing of the first dose is particularly important in the case of buprenorphine (as Subutex/Suboxone®).

NB If the client has not been referred to you, i.e. if the client has been referred to an alternative pharmacy but changed their preference of pharmacy – you must contact the treatment provider to discuss/confirm dispensing arrangements Alternatively if the treatment provider refers a client to you and that client does not attend the pharmacy – you must inform the treatment provider at the earliest opportunity

To work collaboratively with the client, treatment provider and key worker to ensure the objectives of the service are met.

To proactively share information (respecting Caldicott Guidance and Data Protection Law) with appropriate stakeholders regarding concerns that might be likely to affect the clients’ progress.

To have a designated named pharmacist at the pharmacy who will be responsible for the day to day running of the scheme and ensure all locums are informed. If the designated named pharmacist is changed the Operational contact for the INSPIRE Partnership must be informed at the earliest opportunity (within 1 week).

To ensure that they have appropriate indemnity arrangements in place.

2. Responsibilities to Client

To ensure the client is treated as an individual, with respect, and aiming to maintain utmost confidentiality at all times.

To register client on the Patient Medication Record after checking the service user’s identity

At first contact to confirm clients’ understanding of their responsibilities to the pharmacy within the patient contract.

To introduce themselves and any other key members of staff to new clients. The client should also be informed of any other member of staff not present but who may supervise the client at a future date.

11

To remind client when they are nearing the end of the prescription.

A copy of your pharmacy leaflet should be provided and, if appropriate, any restrictions on timings for prescription collection should be discussed with the patient.

A copy of the relevant Patient Information Leaflet should be offered to the patient.

3. Dispensing of Doses

Prescriptions must clearly state for supervised consumption.

Processes must reflect the requirements of the good dispensing practice for controlled drugs

If the prescriber requires (on clinical grounds) that the buprenorphine be crushed prior to administration then the prescription should state to be crushed and supervised.

Pharmacists must be satisfied that the prescription is legal and the quantities and details are correct for that client.

Doses of medication for supervision should be prepared in advance each day (assuming possession of a current prescription in the pharmacy) prior to the client’s arrival and in accordance with the Medicines Act/Misuse of Drugs Act.

Pharmacies must have a suitable quality assurance processes for ensuring accuracy of measured doses.

Doses for consumption on days when the pharmacy is closed e.g. Sundays and Bank Holidays, should be dispensed in individual daily doses and labelled in accordance with the Medicines Act.

Child resistant containers should be used on all home doses where appropriate and advice given to patients about safekeeping of the medicine

4. Withholding Doses

The Pharmacist should withhold medication and seek advice from the key worker when:

There are any problems with the prescription and/or identity of the client

The client misses 3 doses consecutively. If the client has missed 3 doses, or is regularly missing doses, or in cases of missed doses where the pharmacist is concerned about subsequent supervised doses, the key worker should be contacted.

The client does not consume the full dose The client tries to avoid supervision

The client appears ill

The client appears intoxicated (e.g. with alcohol or other drugs)

12

The behaviour of the client is unacceptable (shoplifting, verbal and/or physical abuse).

There has not been satisfactory communication with the key worker regarding timing of the first dose of buprenorphine (as Subutex/Suboxone®).

Client is not complying with the process for correct administration of buprenorphine (as Subutex/Suboxone®).

Supervision of Doses

General Issues

Supervision should take place in a designated area offering suitable privacy for the client, other customers and the general public. Supervision must never take place in the dispensary.

The identity of clients must be confirmed. If regular staff are not available at all times then some form of patient registration card is recommended. In all cases clients should be asked for proof of identification on first attendance. (extra care should be taken for ‘one’ off supervisions)

Following consumption, labels should be removed from containers before disposal to preserve confidentiality.

All necessary paperwork should be completed following supervision of a client in accordance with Medicines Act/Misuse of Drugs Act, updated CD regulations and the Supervised Consumption Scheme.

Supervision will normally continue for 3 months. Pharmacists may contact the key worker for confirmation where this is not the case.

Controlled drug waste should be dealt with in an appropriate manner.

Methadone Supervision Issues

Other than in exceptional circumstances, only Methadone Mixture 1mg/ml should be used. Prescribing and dispensing of an alternative strength should only take place following express prior agreement between the pharmacist and treatment provider.

When a client attends the pharmacy the daily dose can be offered from the bottle or the clients may pour the dose into a disposable cup if preferred.

The client must be observed whilst taking the dose.

The client should be given a drink of water and requested to drink it whilst being observed again.

BEWARE!!!! Some clients may say that they prefer to use a can of soft drink to wash down their methadone. However, what they may be doing is discharging the dose of methadone INTO the bottle for sale later as "spit-methadone". It is preferable to encourage the client to rinse the mouth with water. This will, at least, wash some of the acidic mixture out of the mouth

13

and away from teeth.

The pharmacist should discreetly check that the dose is not retained in the mouth by engaging in some conversation.

The disposable cup should be discarded after single use.

Buprenorphine (as Subutex/Suboxone®) Supervision Issues

The approximate timing of the first dose of buprenorphine (as Subutex/Suboxone®) should be adequately communicated by the key worker, but it will remain the responsibility of the patient to determine when their symptoms are appropriate. The key worker should be contacted in case of query.

The client should be warned that the buprenorphine has a ‘bitter taste’. The pharmacist should also ensure the client understands how the tablet should be taken i.e. sublingually.

The client may be offered a drink of water prior to administration to help speed up dissolution.

The prescriber may request that the supervised buprenorphine will be crushed prior to sublingual administration. The crushing of buprenorphine is outside its product license and as such is not covered by the manufacturer’s liability. If to be crushed;

The pre-dispensed medication for a specific patient should be placed into the tablet crusher (e.g. Portia tablet crusher is recommended) and crushed.

The powder should be placed on a sheet of waxed paper and handed to the patient to administer under the tongue.

Observe the patient and ask them to remain in the pharmacy for 1-2 minutes.

6. Documentation

Pharmacies must retain a copy of signed patient contract (Appendix 2A) for each service user under active supervision.

All missed doses should be recorded on the prescription as not dispensed.

Controlled drug records should be completed in the usual way. It is recommended pharmacists maintain a stock balance of buprenorphine (as Subutex/Suboxone®). (NB not a legal requirement)

Pharmacies must maintain a current list of patients on supervised consumption.

For clients currently on supervised consumption, to record doses supervised / dispensed / withheld doses / incidents/relevant communication with client or key worker.

14

Records are available that document supervised doses and missed doses after the scripts have left the pharmacy (see example of record keeping pro forma in appendix 3)

To keep records of clients claimed for each month – We would suggest keeping a list of patient identifiers.

All documentation relating to the scheme should be retained for a minimum of 3 years and any paperwork adhering to appropriate standards of information governance regarding client identifiable information.

15

Appendix 2

Treatment Providers’ Responsibilities under Supervised Consumption Scheme General Responsibilities

To appropriately identify clients for supervision in accordance with national and local guidance.

To work collaboratively and communicate all relevant information in a timely fashion to appropriate parties.

After 3 months on supervision to review the need for on-going supervision and make necessary arrangements for continuation or cessation of supervision.

To keep clear and adequate records regarding prescribing decisions, including those related to supervision, such that queries from pharmacists or others may be rapidly resolved.

In relation to buprenorphine if crushing is to be requested to ensure that the client understands that the buprenorphine will be crushed prior to sublingual administration and that when crushed buprenorphine is unlicensed.

Clients should only be prescribed 3 doses on a Friday in exceptional circumstances. The INSPIRE Partnership has commissioned pharmacies to provide a 6 day a week service for good cause and this service should be used.

Other than in exceptional circumstances, only Methadone Mixture 1mg/ml should be used. Prescribing and dispensing of an alternative strength should only take place following express prior agreement between the pharmacist and treatment provider.

Responsibilities to Client

To reach an understanding with the client that medication will be dispensed at a designated community pharmacy where administration and consumption will be supervised by the pharmacist

To agree a suitable pharmacy with the client by offering a choice of participating pharmacies within a locality chosen by the client

To confirm availability of supervision at the clients’ choice of pharmacy or make alternative arrangements if first choice not available.

To go through the contract with the client (appendix 2A) and obtain the clients’ signature to this Agreement. This should ensure highlighting the implications of non-compliance with agreement.

To ensure prescriptions are correct and available at the proper time, provided the client has attended appointments as agreed.

Responsibilities to Pharmacist

To contact the designated pharmacy in advance of prescribing to agree their

16

acceptance of individual client.

To discuss dispensing arrangements; NB for buprenorphine (as Subutex/Suboxone®) this should include specific information about approximate timing of doses as appropriate.

To provide details of the client - this should include identifier code, key worker, methadone (or other) dose, start and end date of prescription (also expected for ‘one’ off supervisions)

To confirm client has signed the Agreement.

To clearly endorse prescription ‘For supervised consumption only’.

If buprenorphine is required to be crushed to endorse the prescription ‘For crushed and supervised consumption only’

To inform the pharmacist when clients are taken off the scheme, discharged or move area or pharmacy.

To inform the pharmacy when the client stops supervision, either contact the pharmacy or write on the script ‘supervision stopped’

To respond to any issues highlighted by community pharmacist e.g. intoxication, missed doses etc.

To ensure that prescriptions comply with necessary legal requirements.

To inform pharmacies if (on an individual patient basis) use of an alternative strength methadone mixture has been approved.

17

Appendix 2

Client Contract for Supervised Methadone/ Buprenorphine (Subutex/Suboxone®)* Consumption

*delete as appropriate

Client Name:Key Worker:Prescriber:Pharmacy:Pharmacy Address:

I understand that in order to participate in the Supervised Consumption Scheme I must read and agree to the following terms and conditions:

Appointments and Prescriptions:

I agree to attend my appointments with my key worker/ prescriber on time and alone. I understand that if I miss my appointment without prior notice I may not be seen.

I understand I am responsible for the safe-keeping of my prescription once issued and that there will be NO replacements for ‘lost’ or ‘stolen’ prescriptions.

I understand that I may be required to provide a sample of urine, or OMT swab for analysis

I understand that if I attend for my appointment intoxicated, I may not be seen and that my treatment may be subject to review.

Dispensing of Medication

I agree that I will not use my own drink (e.g. cans of Coke etc.) immediately after swallowing my medication but will take the drink of water provided.

I understand that I will need to return the empty bottle/cup back to the pharmacist for their disposal.

I realize that the pharmacist is advised to refuse to supply me with my medication if he/she suspects that I am intoxicated and will refer me back to the clinic. This is a safety measure and is meant in my best interest.

I understand that I will be given a dose for the days when the pharmacy is closed e.g. Sundays and Bank Holidays and I will be responsible for this supply. Replacement medication will not be given under any circumstances including ‘lost’, ‘spilled’ or ‘stolen’ doses.

I accept that if I do not attend for my medication, the pharmacist may notify my key worker of my non- attendance, who will inform my prescriber.

I understand that if I miss consecutive supervised doses, the pharmacist is instructed to refuse any further supplies and refer me back to my key worker.

18

I understand that if I miss a day’s supply, I will not be able to receive it at a later date.

Dispensing of Supervised Methadone:

I understand that I will be required to swallow my daily dose of methadone at the pharmacy followed by a drink of water. If I refuse to comply then the pharmacist is instructed to inform my key worker and my prescription may be reviewed.

Dispensing of Supervised Buprenorphine (Subutex/Suboxone®):

I understand that I must attend for administration of the buprenorphine (Subutex/Suboxone ®) at the specified time, particularly for the first dose, as discussed with my key worker.

I understand if requested by my clinician that the buprenorphine tablets (Subutex/Suboxone®) will be crushed by the pharmacist and I will then have to place the crushed tablets under my tongue under the supervision of the pharmacist. I understand that this is not a licensed use of the tablets. I understand that buprenorphine (Subutex/Suboxone®) is administered sublingually. I understand that the pharmacist will need to observe me on the premises for up to 2 minutes. If I refuse to comply with the above then the pharmacist is instructed to inform my key worker and my prescription may be reviewed.

Behaviour:

I understand that any unacceptable or anti-social behaviour e.g. violence, verbal abuse, aggression, shoplifting etc. will result in the immediate suspension of the dispensing of my medication and I may no longer receive my medication from that particular pharmacy. I will be referred back to my treatment provider.

I fully understand the above conditions which were explained to me by INSERT NAME OF KEYWORKER and agree to comply with them.

Client Signature:Date:

Keyworker Signature:Date:

Copy: Client Case Notes, Client, Community Pharmacy

19

SECTION B

SLA NEEDLE EXCHANGE SCHEME

1. Service Description

1.1 This service requires pharmacies to provide the full range of needle exchange and disposal services

1.2 Pharmacies will offer a user-friendly, non-judgmental, client-centered and confidential service.

1.3 The pharmacy will provide support and advice to the patient, including referral to primary care or specialist centers where appropriate.

2. Service Aims and Objectives

The aims and objectives of needle exchange facilities and harm reduction services are:

To offer user-friendly, non-judgmental, client-centered and confidential services.

To assist the service users to remain healthy until they are ready and willing To cease injecting and ultimately achieve a drug-free life with appropriate

support. To reduce the rate of sharing and other high risk injecting behaviors by

providing sterile injecting equipment and other support. To encourage users of the Needle Exchange service who are not in treatment

to attend INSPIRE for treatment. To reduce the rate of blood-borne infections among drug users. To reduce drug-related deaths (immediate death through overdose and long-

term such as blood- borne infections). To promote safer injecting practices. To provide focused harm reduction advice and initiatives, including advice on

overdose prevention (e.g. risks of poly-drug use and alcohol use). To provide and reinforce harm reduction messages. To help service users access drug treatment to refer to other specialist drug

(and alcohol) treatment services. To help service users access other health and social care and to act as a

gateway to other services (e.g. key working, prescribing, hepatitis B immunization, hepatitis and HIV screening, primary care services etc).

To facilitate access to primary care where relevant. To ensure the safe disposal of used injecting equipment. To aim to maximize the access and retention of all injectors, especially the

highly socially excluded, through the low-threshold nature of service delivery and interventions provided.

To prevent initiation into injecting and to encourage alternatives to injecting. To improve the health of local communities by preventing the spread of

blood-borne viruses and by reducing the rate of discarded used injecting equipment.

20

3. Service Location

Overall provision of needle exchange / harm reduction services (type and location) will be determined based on a local needs analysis undertaken by the specialist commissioners. All community pharmacies Sutton will be given the opportunity to consider offering to provide this service. The INSPIRE Partnership intends to commission a minimum of 4 pharmacies spread across Sutton to participate in each aspect of this scheme. Due to the changing nature of drug misuse trends there may be a need to review these locations as the needs assessments are updated.

4. Level of Provision

The pharmacy will agree to provide the service on pharmacy premises for the full duration of opening times.

Pharmacies are expected to provide a minimum of 15 transactions per month to continue to participate in the Needle Exchange Scheme. INSPIRE will review activity via NEO and will consult with pharmacies who may be falling below the minimum requirements.

5. Service Standards

a. Joint working

b. Promoting patient understanding of the NHS and Recovery Services

c. Governance Arrangements

Standard A – Joint Working

The pharmacy will:

Work within local protocols and arrangements outlined in the Service Specification for Needle Exchange (Appendix 1).

The pharmacy needle exchange coordinator at IRiS will:

Be the point of contact for any queries concerning scheme. Ensure initial and on-going training is available as required. Share with commissioners’ responsibility for the co-ordination, maintenance

and review of the scheme. Ensure that pharmacies are adequately stocked with needle exchange

equipment, and appropriately supported to carry out the service. Ensure NEO is updated for every transactions and the mandatory information

is completed.

The INSPIRE Partnership will:

Ensure arrangements are in place to process payments. Ensure compliance with the scheme by providers commissioned by the

INSPIRE Partnership (i.e. pharmacies).

Standard B – Promoting Patient understanding of the NHS

21

The pharmacy will promote a continuing understanding of the NHS health and social care system to encourage the patient to use the services in a responsible, appropriate and safe way in the future.

Standard C – Governance Arrangements

Pharmacies are required to operate to appropriate standards of clinical governance as detailed in Essential Services 8 of the Community Pharmacy Contractual Framework (2005). Pharmacy contractors are also expected to comply with the appropriate Standards for Better Health or equivalent and be able to provide suitable evidence of such to the INSPIRE Partnership in support of governance assurance. Monitoring against these standards will seek assurance of quality of service delivery applicable to these services.

Of particular note with regards to this service:

(i) Risk ManagementThe designated pharmacist must ensure that appropriate arrangements are in place to minimize risk to clients, provider, pharmacy staff and other patients. This will include the use of Standard Operating Procedures for the service, taking steps to ensure all staff are appropriately trained and giving adequate consideration for clinical audit and standards of record keeping.

(ii) Confidentiality/Information SharingPharmacies should be mindful of the need to protect patient confidentiality by avoiding, where practical, data flows which identify individuals. It is well recognized that there is an obligation to share information between professionals and agencies to ensure that appropriate services are provided and safe working practices are adopted. Pharmacists, doctors and providers should be encouraged to share information, respecting Caldicott Guidance, between health and social services agencies, prison, police and other relevant sources to build up a picture of past behavior so that risk can be assessed.

(iii)ClinicalThe pharmacist will have clinical responsibility for the completion of the exchange of equipment ensuring necessary protocols and procedures are in place and followed.

(iv) Incident ReportingThe pharmacy will undertake to complete an incident report, as appropriate, for every incident occurring during the provision of needle exchange An incident is defined as any occurrence that is not consistent with the professional standards of care of the patient or routine operation/policies of the organisation.

(v) AuditThe pharmacy will participate in any INSPIRE Partnership coordinated audit of the service.

(vi)Education and Training

Participating community pharmacies must ensure that a designated Pharmacist attends the required two training sessions per annum. (Training will cover issues such as Harm Reduction, Safeguarding, the NEO System, Wound Care and Blood Borne Viruses). Failure to attend may result in payments being delayed. Persistent failure to attend will result in the pharmacy’s ongoing participation in the scheme being reviewed.

22

Community Pharmacy Service - Needle Exchange

All participating community pharmacies must ensure that a designated pharmacist attends the local scheme induction training. It is the responsibility of the designated pharmacist to be assured that all staff (including support staff and locum pharmacists) are adequately trained to meet the requirements of the service at all times. The pharmacy needle exchange coordinator will provide detailed training to prepare pharmacy staff for the scheme. Resource material provided during the training should remain available at the pharmacy for future reference. Training schedule will generally include:

The role of Needle Exchange (Nx) schemes in the Sutton Treatment System Introduction to the INSPIRE Substance Misuse treatment service. Aims & objectives of Community Pharmacy Needle Exchange. Role of the Scheme Coordinator. Other provision of NX in Sutton. The exchange procedure. Equipment used within NX. Clinical waste management. Health promotion, safer injecting, overdose, drug awareness. Policies & procedures including needle stick injuries, disposal of sharps, blood

borne viruses, confidentiality, contra-indications to service, dealing with young people.

FAQs.

Update training will be attended as required; usually twice yearly.

6.0 Service Monitoring

In order to monitor the service the pharmacy must maintain accurate records of the service as described in Appendix 1 and complete the mandatory information on NEO to ensure payment is processed in a timely manner.

7.0 Provision for Disruption of Service

Information outlining the process of the scheme must be cascaded to other pharmacy staff, including locum pharmacists to ensure continuity of the service.

8.0 Reimbursement

Participating pharmacies will receive a reimbursement for Needle Exchange of 2.45 per episode.Community Pharmacies should complete the mandatory information for every transaction via NEO and finalise the activity data for each month by the 8th of the following month. It is good practice for this to be completed at the time of the transaction but INSPIRE recognises that operational pressures may prevent this.

Invoices for payment will be generated by the NEO system. These will be raised around 8th of each month and verified by Cranstoun in a timely fashion and paid, whenever possible, within 30 days of verification. Undue delay in in verifying an invoice will not to be sufficient justification for failing to regard an invoice as valid and undisputed.

23

9.0 Duration of Agreement

This SLA will become operational from 1st April 2018 and will be reviewed in two years, unless any major service alterations are required before this date.

10. Termination of Agreement

Any pharmacy wishing to terminate this agreement must give 1 months’ notice prior to termination. Notice of termination must be written and submitted to the INSPIRE Partnership Operational Lead. The latter will ensure that all relevant parties are informed of this decision.

Please note: The INSPIRE Partnership may also terminate this agreement with 1 months written notice, or less should circumstances arise in which the pharmacy is ineligible to continue, i.e., the INSPIRE Partnership may terminate this agreement with immediate effect if the pharmacy is without a designated pharmacist for the service and an interim agreement has not been authorised.

The agreement will also terminate immediately should LB Sutton withdraw consent for the pharmacy to be appointed to deliver service for the INSPIRE service (see 13.2)

The INSPIRE Partnership may also terminate this agreement with 1 months written notice, or less should the pharmacy not meet the minimum monthly transaction requirements (15 transactions).

Following termination all excess Needle Exchange stock will be collected by INSPIRE Partnership from the pharmacy and re-distributed within the Sutton Borough.

11. Dispute Resolution

Dispute resolution will follow appropriate INSPIRE policies and procedures.

12. Operational Points of Contact

Darren Nicholas – Borough ManagerINSPIRETel: 07917642644 Email: dnicholas@inspirepartnership.org.uk

24

13. Prime Contract

13.1 This Service Level Agreement is made with reference to a contract to provide Public Health Services - Substance Misuse and Associated Service dated 1st April 2016 between Cranstoun and The Mayor and Burgesses of The London Borough of Sutton (the Prime Contract) annexed hereto. In entering into this agreement to provide Supervised Consumption and/or Needle Exchange Services the Pharmacy acknowledges that it agrees to be bound by, and undertakes to Cranstoun to comply with, all the terms of the Prime Contract which do not apply exclusively to Cranstoun, and as further defined and agreed in this Agreement, so that the Cranstoun is able to fulfill its obligations to the Council under the Prime Contract. In the event of any conflict arising between the terms of this Agreement and those of the Prime Contract, the terms of the Prime Contract shall prevail.

13.2 Cranstoun must provide details of the community pharmacies being used for the INSPIRE service to the LB Sutton (including details of ownership and manner in which the organisation is structured e.g. sole trader, partnership or limited company) prior to entering any agreement. The LB Sutton must consent to appointment of each pharmacy and the appointment is therefore subject to the ongoing consent of LB Sutton.

14. Signatories to the Agreement (NEEDLE EXCHANGE)

I hereby declare that Sutton Pharmacy Surrey, operating from 86 Westmead Rd, Sutton SM1 4HY, wishes to participate in the Needle Exchange Scheme in accordance with the terms outlined above.

Signature on behalf of the Pharmacy owner:

Signature: Name:Organisation:Date:Job Title:

Designated named pharmacist (if different from above)

Signature on behalf of Cranstoun:

Signature:Name:Position:Date:

Issued: 1st April 2018Review Date: 31st March 2021

25

Appendix 1:

Service specification

1. Description of ServiceThis service specification relates to the provision of needle exchange and other related harm reduction facilities within a pharmacy setting. These facilities are developed to prevent blood- borne diseases (most particularly HIV and hepatitis) and other drug-related harm, including drug- related death. They often have contact with drug misusers not in touch with other specialist drug treatment services. Needle exchange facilities and harm reduction initiatives should provide an easy access and low-threshold service. Needle exchange and harm reduction initiatives are developed within a wider approach that advocates the following hierarchy of goals:

stopping sharing injecting equipment moving from injectable to oral drug use decreasing drug misuse abstinence promote engagement with services

The provision of these services includes the distribution of sterile injecting equipment, and collection of returns for their safe disposal, and the ongoing provision of a range of other harm reduction support for the users of services. Needle exchange facilities are also important public health measures. They have a health remit, as well as a social welfare role within the wider community.

2. Client group served, eligibility and priority groups Injectors:

Needle exchange facilities are available to all adult injectors, but special attention should be given to:

service users who are not in touch with other drug and alcohol misuse treatment services

injectors who are under-using the service; this includes but is not limited to: women amphetamine and cocaine/crack injectors minority ethnic injectors younger injectors (see below for more information) injectors who have characteristics associated with high risk injecting

practices: poly-drug users (including use of opiates, stimulants, benzodiazepine and

alcohol) people with severe drug dependence frequent injectors people who have spent time in prison, especially those released from prison people who have left residential rehabilitation and those who have left in-

patient facilities. people who spend more time with other injectors homeless or people in poor accommodation those with a sexual partner who injects those out of treatment Steroid and other performance enhancing drug users

Non-injectors:

26

Where possible, needle exchange and harm reduction facilities should also provide interventions relevant to non-injectors. These include, but are not limited to:

interventions to prevent transition into injecting interventions aimed at reducing the harm of smoking crack cocaine ( see

NTA's service specifications/guidance on working with crack users) Interventions aimed at reducing harm of other drugs (e.g. cannabis, ecstasy

etc.).

3.0 Community Pharmacy Responsibilities under Needle E xchange Scheme

3.1 General responsibilities

3.1.1To ensure all pharmacists providing the service are appropriately registered with the Royal Pharmaceutical Society of Great Britain.

3.1.2To ensure the service should be conducted in accordance with any RPSGB guidance as usually presented in the most recent issue of Medicines, Ethics and Practice:http://www.rpsgb.org.uk/informationresources/downloadsocietypublications/#M

3.1.3 To identify a designated named pharmacist who will take overall responsibility for ensuring the service is provided to the required standards.

3.1.4 The service will be expected to be available during the full duration of the pharmacy opening hours.

3.1.5 The part of the pharmacy used for provision of the service should provide a sufficient level of privacy and safety and meets other locally agreed criteria.

3.1.6 The pharmacist entering into the commissioning arrangement will ensure that the equipment and facilities necessary for the provision of the service are available in the pharmacy.

3.1.7 The pharmacy will allocate a safe place to store equipment and returns for safe onward disposal. The storage containers provided by the commissioned clinical waste disposal service will be used to store returned used equipment.

3.1.8 Pharmacists will be required to adhere to all statutory requirements in relation to the storage and disposal of syringes and needles.

3.1.9 The pharmacy should clearly display the national scheme logo or a local logo indicating participation in the service.

3.1.10 The pharmacy will work collaboratively with the client; treatment provider and key worker to ensure the objectives of the service are met.

3.1.11 The pharmacy will proactively share information (respecting CaldicottGuidance) with appropriate stakeholders regarding concerns that might be likely to affect the clients’ progress.3.1.12 The pharmacy contractor will ensure that pharmacists and staff involved in the provision of the service have relevant knowledge and are appropriately trained in the operation of the service. Additionally, they are aware of and operate within local protocols including the maintenance of required

27

documentation.

3.1.13 The pharmacy will maintain appropriate records to ensure effective ongoing service delivery and audit.

3.1.14 The pharmacy will participate in any organized audit of service provision and any agreed assessment of service user experience.

3.2 Responsibilities to Client

3.2.1 Ensure the client is treated as an individual, with respect and aiming to maintain utmost confidentiality at all times.

3.2.2 Pharmacy staff should introduce themselves and any other key members of staff to new clients.

3.2.3 A copy of the pharmacy leaflet should be available.

3.2.4 A copy of the relevant patient information leaflet should be offered to the client.

3.3 Needle exchange process

3.3.1 Transactions involving needle exchange must be conducted under the supervision of a pharmacist.

3.3.2 The pharmacy will work with the scheme coordinator to maintain adequate stocks of kits to meet the anticipated demand. Kits should be stored in such a way so as to be inaccessible to customers. Community Pharmacy Enhanced Service - Needle Exchange storage conditions must be appropriate for the storage of sterile medical equipment.

3.3.3 The pharmacy will have in place a suitable Standard Operating Procedure to cover all processes involved in delivery of the scheme. Company policies are acceptable where they reflect the principles of the scheme. The SOP should be readily available to all members of staff and in particular Locum staff.

3.3.4 The pharmacy will ensure that their staff are made aware of the risk associated with the handling of returned used equipment and the correct procedures are used to minimize those risks. A needle stick injury procedure should be in place.

3.3.5 Appropriate protective equipment, including gloves, overalls and materials to deal with spillages, should be readily available close to the storage site and protocols include their use.

3.3.6 Safe handling arrangements are to be in place for dealing with the returned used equipment. It is important that sharp bins are assembled correctly as per the manufacturer instructions. The Sharp bin should not be accessible to customers and if at all possible should not b e stored in the dispensary.

3.3.7 Pharmacy staff must ensure that clients place their used returned equipment in the sharp bin. Pharmacy staff must not handle used equipment.

28

3.3.8 Unused kits returned by clients must be disposed of in the sharp bin; they must not be re-issued since their integrity cannot be ensured.

3.3.9 Records of supply will be completed as part of the transaction

3.4 Withholding services

3.4.1 Young people under the age of 18 (or those perceived to be under the age of 18) should not be allowed to participate in needle exchange services. In these cases they should be referred to Young Persons services that may (following assessment) be able to offer this service. If the young person is not willing to be referred on then the pharmacist should seek to give information and advice about the risks of injecting.

3.4.2 For those customers aged under 18 (or those perceived to be of this age) the pharmacy staff should seek to encourage the person to utilise young person’s services or the adult central service needle exchange site, rather than pharmacy needle exchange. Only where the person refuses this and the pharmacist considers the person is at risk of using shared needles obtained elsewhere, should needles and syringes be given the person.

3.4.3 For those clients in the transitional stage of drug misuse (whereby they are not currently injecting but have indicated they wish to start) the procedure for 3.4.2 applies also.

3.4.4 Needle exchange and harm reduction initiatives are open access services, and clients should only be excluded for behaviour that has breached accepted rules and standards at the discretion of the service but within a structure of users' rights and responsibilities. Where appropriate, work is carried out to re-engage clients in this or other more appropriate services and refer them to needle exchange schemes in community pharmacists in the interim.

3.4.5 Service users may be excluded as a result of a professional risk assessment and if they pose a serious risk to staff, other service users and members of the public. Referral to more appropriate services is made where possible.

4.0 Coordinator’s Responsibilities under Needle Exchange Scheme

4.1 General Responsibilities

4.1 .1 To work collaboratively and communicate all relevant information in a timely fashion to appropriate parties.

4.1.2 To coordinate local training at service induction and staff updating and development as required ensuring that pharmacists and staff involved in the provision of the service have relevant knowledge and are appropriately trained in the operation of the service.4.1.3 To ensure that pharmacists and staff involved in the provision of the service are aware of and operate within local protocols.

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

4.2 Responsibilities to Client

29

4.2.1 To ensure the client is treated as an individual, with respect and aiming to maintain utmost confidentiality at all times.

4.2.2 To proactively work with clients excluded from the service to integrate with mainstream treatment providers

4.3 Responsibilities to Pharmacy Provider

4.3.1 Respond to any issues highlighted by community pharmacist providers.

4.3.2 Arrange for pharmacists and staff involved in the delivery of this service to be offered any relevant immunisation, including Hepatitis B.

4.3.3 Provide the exchange packs and associated materials and commission a clinical waste disposal service for each participating pharmacy

4.3.4 Provide details of relevant referral points which pharmacy staff can use to signpost service users who require further assistance.

4.3.5 obtain or produce health promotion material relevant to the service users and make this available to pharmacies

30