Agenda item 15

DRAFT 3DOCUMENT

CountyDurham DAAT and CountyDurhamand DarlingtonLocal Pharmaceutical Committee

Pharmaceutical services for Drug Users Receiving Supervised Consumption of Methadone

Introduction

Current guidelines recommend that all new treatment for opiate dependence be subject to supervised consumption for the first three months or a longer period considered appropriate by the prescriber. The rationale for this recommendation is to provide routine and structure for the client, helping to promote a move away from chaotic and risky behaviour.

It is well recognised that community pharmacy has a major role to play in the overall harm minimisation strategy by providing pharmaceutical care to drug users. Supervised consumption of methadonethrough community pharmacies is an integral element to the overall shared care services provided to support people who misuse substances –heroine in particular.

Supervised consumption of prescribed medication is an enhanced service within the community pharmacy contractual framework commissioned by County DurhamPrimary Care Trust, through County Durham DAAT to meet the needs of the population of CountyDurham. It excludes Darlington Pharmacies and people living Darlington as there is a separate DAAT for the unitary authority.

The aims and intended service outcomes of a supervised consumption enhanced service is to

  1. Ensure compliance with the agreed treatment plan by:
  • Dispensing in specified instalments
  • Ensuring each supervised dose is correctly consumed by the patient

for whom it was intended

  1. Reduce the risk to local communities of:
  • over usage or under-usage of medicines
  • diversion of prescribed medicines onto the illicit drugs market
  • accidental exposure to methadone by those for whom it was not intended
  1. Provide service users with regular contact with healthcare

professionals and to help them access further advice or assistance by:

  • referring to other healthcare and social care providers where appropriate.

Service Level Agreement

This is a service level agreement for the supervised consumption of methadone for substancemisusers by community pharmacy contractors within County Durham Primary Care Trust (CDPCT) area. The SLA is between CDPCT and community pharmacy contractors in CDPCT on behalf of the County Durham Drug and Alcohol Action Team (DAAT).

It is anticipated that this SLA will be extended to cover buprenorphine (as Subutex®). Currently there is no SLA to cover payments for buprenorphine (as Subutex®) supervision and these supervisions should not be claimed against this SLA.

Contents

  1. Service Aims
  1. Service Objectives
  1. Service Location
  1. Level of Provision
  1. Service Standards
  1. Service Monitoring
  1. Provision for Disruption of Service
  1. Reimbursement
  1. Termination of Agreement
  1. References and Bibliography
  1. Signatures and Dates

Appendices

1 Community Pharmacist responsibilities,

2 Treatment providers’ responsibilities

3 Client Agreement for supervised consumption

4 Monthly Invoice outlines

5 Treatment providers list

6 Pharmacists participating in scheme

  1. Service Aims

To provide a service to treatment users and providers which will help to ensure that prescribed medication is consumed under professional supervision and that appropriate information is recorded.

At this time methadone is the only medication included in the agreement. The range of products will need to be reviewed on a regular basis as new products become available and recommended within CountyDurham. It is anticipated that the first that will be added is buprenorphine (as Subutex®) once issues regarding its product licence and its suitability for crushing have been addressed.

  1. Service Objectives
  • To ensure compliance with national guidance for supervision arrangements1, 2.
  • To reduce the possibility of accidental poisoning
  • To prevent prescribed medication being diverted to the illegal market
  • To support concordance
  1. Service Location

To ensure PCT-wide access to supervised consumption services, all community pharmacies within CDPCT area will be given the opportunity to provide this service. All participating pharmacies will be expected to offer supervised consumption of methadone. In the future participating pharmacies will be given the opportunity to additionally supervise consumption of buprenorphine (as Subutex®) once an agreement has been agreed regarding its un-licensed use.

  1. Level of Provision

Ideally the pharmacy will agree to provide the prescribed dose of methadone for daily consumption on pharmacy premises for 7 days a week (Monday to Sunday ~ excluding Bank Holidays).

However, there is recognition that the rural and diverse nature of CountyDurham means that this level of service provision is not always available. In these locations it is anticipated that supervision will be available at an agreed timeduring the contractors’ premises are open for business.

Prescribed doses for days when the premises are not open for business e.g. Sundays and Bank Holidays, and in rare exceptions Saturdays, will be dispensed on the last working day before,in a standard container to take away, as required by the Medicines Act.

A safe client list size will be determined with each contracted pharmacy’s clinical governance and risk management criteria and agreed with the DAAT. Where pharmacy contractors reach and maintain a list size of 20 clients support can be made available through the purchase of an additional controlled drugs cabinet or methadone pump. To be considered for this, contractors would need apply to the DAAT and it would be considered by the DAAT Unit Manager and the Head of Medicines Management, CDPCT.

  1. Service Standards
  1. Joint working / shared care
  1. Promoting patient understanding of the NHS and social care system in relation to harm minimisation.
  1. Governance arrangements

Standard A – Joint Working/Shared care

The contractor will

  • work within local arrangements outlined in the Community Pharmacy Responsibilities for Supervised Consumption (Appendix 1).

Treatment providers

  • will be expected to follow the Treatment Providers Protocol for Accessing Supervised Methadone (Appendix 2).

The DAAT will

  • maintain and distribute a list of treatment providers (Appendix 4) who are participating in the scheme
  • ensure compliance with scheme by treatment providers commissioned by the DAAT
  • share with CDPCT responsibility for co-ordination, maintenance and review of the scheme.
  • Commission training to update Pharmacists on current good practice
  • Maintain a list of accredited pharmacists in CountyDurham approved to be part of the scheme covered by this agreement

CDPCT will

  • be the point of contact for any queries concerning scheme
  • ensure arrangements are in place to process payments
  • ensure initial and on-going training is available as required
  • ensure compliance with the scheme by treatment providers commissioned by the PCT
  • share with DAAT responsibility for co-ordination, maintenance and review of the scheme.

Standard B – Promoting Patient understanding of the NHS and social care system on relation to harm minimisation.

The contractor 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. This will involve signposting to other services and involvement in health promotion campaigns and publicity. It will also make clients aware of the Patient Advise and Liaison Service offered by CDPCT.

Standard C – Governance Arrangements

Confidentiality/Information sharing

Contractors should be mindful of the need to protect service users confidentiality by avoiding, where practical, data flows which identify individuals.

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 adopted2. 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 behaviour so that risk can be assessed.

All service users will be will be asked to give informed consent as part of their agreement to shared care within the supervised medication protocols.

Risk Management

The pharmacy contractor must ensure that appropriate arrangements are in place to minimise risks to client, provider, pharmacy staff and other patients.

Clinical and pharmaceutical Management

The pharmacist will have clinical responsibility for dispensing the prescription and for supervision arrangements, ensuring necessary checking procedures for accuracy and safety are in place. A standard operating procedure will be in place for the enhanced service for supervised consumption of medication.

The extemporaneous dispensing of methadone is not recommended as per RPBGB guidelines. If this is necessary due to storage constraints then a SOP for the process, extemporaneous dispensing records and a secure audit trail will be required as part of the governance arrangements within the community pharmacy contractual framework.

Incident Reporting

The designated pharmacist for each contractor will undertake any incident report, as appropriate, for every incident occurring during the provision of supervised methadone consumption.

An incident is defined as any occurrence that is not consistent with

  • the professional standards of care of the service user,
  • the standards within this service level agreement
  • the routine operational policies of the organisation
  • the standards of behaviour expected of the service user.

Harm Reduction Advice and Support

Pharmacists should provide direct input wherever possible to promote harm reduction, to include:

  • Signposting people with physical or mental health problems referring them onto appropriate services
  • Identification of immediate risks (such as injection site injuries) and provide appropriate advice, treatment or referral
  • Actively encouraging service users to access hepatitis B immunisation
  • Emphasise the risks of overdose and strategies to reduce those risks and to respond to overdose
  • Advise on sexual health issues including safer sex
  • Advise on blood borne viruses especially Hepatitis B and Hepatitis C as well as HIV and HIV testing

Education and Training

For the 2007 SLA participating pharmacy contractorsmust ensure that a designated pharmacist has completed the current CPPE Distance Learning Package ‘Substance use and Misuse’, equivalent to 10 study hours. This must be completed and a certificate received before 31st October 2007 if pharmacy contractors wish to be eligible for participating in the service detailed in this SLA. During this time designated Pharmacists will also be expected to attend a local training session which will provide an opportunity to explore how the scheme operates organised by County Durham DAAT.

Further update training will be available at 6 monthly intervals within CountyDurham and Pharmacy contractors will only be eligible to enter the scheme and hence be paid for the supervision of methadone after satisfactorily completing this training.

All participating community pharmacy contractorsmust ensure that a designated pharmacist attends a local scheme implementation meeting. 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.

In the situation where the provision of the designated pharmacist is not possible, then a senior dispensing technician who has signed the SOP could assume the role, provided that CDPCT is aware of this circumstance and agreed.

Pharmacy contractors are expected to meet these criteria during operating hours. If these criteria are not met then the contractor should report this to the DAAT Unit as they would for incident reporting.

  1. Service Monitoring

In order to monitor the service, the pharmacy must maintain accurate records of the service as described in Appendix 1 and complete a summary monthly return to County Durham DAAT (Appendix 4).

The pharmacy must make available these records on request by CDPCT.

  1. Provision for Disruption of Service

In the unlikely event that the service is disrupted due to unforeseen circumstances, County Durham PCT as the service commissioner and the prescribers must be informed so that arrangements can be make to prevent disruption to service users.

Contingency planning arrangements must be in place in each pharmacy as part of the SOP to allow continued provision of the service in emergency situations. Information outlining the contingency plans of the scheme must be cascaded to other pharmacy staff, including locum pharmacists to ensure continuity of the service.

  1. Reimbursement

The payment schedule for 2007/8 will be in staged installments.

1st April 2007-30th June 2007. Pharmacy contractors will continue to be paid £1.25 per supervision using the agreed forms submitted to the DAAT Unit for payment at the end of each month.

1st July 2007-31st October 2007. Pharmacy contractorswill be paid £1.50 per supervision using the agreed forms submitted to the DAAT Unit for payment at the end of each month. During this period Pharmacists will be offered training in keeping with that outlined in this document. Any Pharmacy contractorswishing to remain part of this enhanced service must have at least one Pharmacist who has undertaken the training and a SOP is in place that demonstrates what will happen should that member of staff be absent from the premises.

1stNovember 2007-31st March 2008. A fully inclusive fee per client will be paid monthly, on the provision of at least 14 days supervised treatment in that calendar month. The fee for this period will be £41. Pharmacy contractors that do not have a member of staff trained, as described in this document will not be eligible for any payment. They will not be covered by this agreement until they have undertaken this training.

Payments will be made via County Durham DAAT Unit, 1stFloor Adelaide House Belmont Business Park, DH1 1TW.

Overall remuneration will be reviewed and set in March of each subsequent year.

Community pharmacy contractors should submit the monthly return to County Durham DAAT Unit by the 6th of the month for the previous month. The return detailing the fees for total number of clients supervised in the previous calendar month. These Invoices are laid out on Appendix 4. There are two types based on the changes in payment schedules from 1st July until 31st October 2007. The second will commence on 1st November 2007.

  1. Resolution of disputes.

It is hoped that contractual issues will be able to be resolved at a local level between the DAAT Unit and individual pharmacy contractors. However, where issues remain unresolved the following levels of escalation are suggested.

  1. LPC/DAAT/CDPCT substance misuse subgroup
  2. Director of Public Health CDPCT/Medical Director CDPCT and Chief Officer of LPC.
  1. Termination of Agreement

Any pharmacy contractor wishing to terminate this agreement must give 3 months notice prior to termination. Notice of termination must be written and submitted to the Head of Medicines Management CDPCT and copied to the DAAT Unit manager.

CDPCT and DAAT may also terminate this agreement with 3 months written notice.

  1. References and Bibliography
  1. The Orange Book – Drug Misuse and Dependence- Guidelines on Clinical Management. Department of Health 1999
  2. Medicines, Ethics and Practice A Guide for Pharmacists Version 28, RPSGB July 2004

Additional resources used in preparation of the Appendices:

Best Practice Guidance for Commissioners and providers of pharmaceutical services for drug users. (2006) National Treatment Agency.

  1. Signatories to the Agreement

I hereby declare that ………………………………..(Pharmacy) operating

from……………………………………………………………………………………

(Registered Pharmacy premises)

agrees to participate in the supervised consumption scheme for

Methadone

Following the training session on …………………………., 2007.

in accordance with the principles outlined above.

Signature on behalf of the Pharmacy:

Signature / Name / Date
Designated named pharmacist ( if different from above)
Or
Clinical governance lead Designated

Signature on behalf of the PCT:

Signature / Name / Date

Written: June 2007

Review Date:March 2008

Appendix 1

Pharmaceutical services for Drug Users

Supervised Consumption of Prescribed Methadonefor Drug users

Community Pharmacy Contractors Responsibilities

  1. General Responsibilities
  • 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 patients for supervised consumption who have been appropriately referred by the treatment provider. The initial prescription will be brought to you by the key worker at an approximate time previously communicated via their key worker or posted.
  • To work collaboratively with the client, treatment provider and key worker to ensure the objectives of the service are met in accordance with the clients care plan.
  • To proactively share information (respecting Caldicott Guidance) 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 named pharmacist is changed the PCT must be informed at the earliest opportunity. The replacement pharmacist will be allowed to take over but must complete the CPPE course and attend a training session. A named lead dispenser could act as the designated person as detailed in SLA providing the requirements of the SLA are met.
  • To ensure that they have appropriate indemnity arrangements in place.
  • To complete the claim forms by 6th of the month subsequent to that being claimed for.
  1. 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 (PMR identification card may be used as a form of identification).
  • 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.
  • To remind client when they are nearing the end of the prescription.
  • A copy of your practice 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.
  • To make the client aware of the complaints procedure and contact details of the Patient Advise and Liaison Service (PALS) of the PCT

3.Dispensing of Doses