Local Enhanced Service September 2009 / March 2011

Supervised Methadone/Buprenorphine Scheme

Drug Misusing Patients

1Agreement

1.1 This Agreement is between Staffordshire County Council acting on behalf of Staffordshire County Drug and AlcoholAction Team and (please enter name, address and contact details of your pharmacy)

Insert your pharmacy details ……………………………………………………………………………….

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1.2The Agreement covers a payment from the Pooled Treatment Budget for Staffordshire in 2009/11. The provider therefore recognises that the payment of the service charge is dependent on (and conditional on) the funding allocation. In the event of termination of the contract due to funding allocation, charges for services already delivered will be paid.

1.3This Agreement (including all Appendices) constitutes the overall Agreement between the parties. The adherence of the provider to the Agreement is set out in clauses 6 & 7.

1.4This is an 18 month contract, which may be terminated by any party, with not less than 28 days notice of termination coupled with a reason for this action. However in the event of performance concerns Staffordshire County Council has the right to suspend this service with immediate effect.

2Introduction

2.1All pharmacies are expected to provide essential and those additional services they are contracted to provide to all their patients. This locally enhanced service specification outlines the more specialised services to be provided.

2.2The specification of this service is designed to cover the enhanced aspects of clinical care of the patient, all of which are beyond the scope of essential services. No part of the specification by commission, omission or implication defines or redefines essential or additional services.

2.3For the purposes of this document, prescribed medicine refers to the supervision of Methadone/Buprenorphine.

2.4Methadone/Buprenorphine are the mainstays of substitute prescribing as part of the treatment of opiate addiction. However, Methadone/Buprenorphine also carries associated risks and is potentially subject to misuse.

2.5National and local guidelines indicate that supervised Methadone/Buprenorphine within community pharmacies can significantly reduce the illicit diversion of prescribed drugs onto the streets, thus playing an important role in contributing to the effectiveness and safety of prescribing interventions for the treatment of opiate dependence.

2.6Patients who regularly fail to consume their full methadone dosage reserving an amount to illicitly sell-on, can be expected to be intolerant to full dose. If they find themselves in a situation where the drug is administered under controlled conditions e.g. hospital or prison, a life-threatening overdose may result. Supervised Methadone/Buprenorphine can significantly reduce these risks.

2.7 Additionally, community pharmacists provide a significant point of contact as part of primary healthcare services and have regular (often daily) contact with the patient. Hence their role in the care of drug users is crucial. Regular communication between pharmacists, prescribing doctors and drug workers is essential for treatment to be effective.

3 Role and Responsibilities of the Pharmacist

31The pharmacist’s role is set out in the local Supervised Dispensing Protocol (see Appendix 1). It covers the relationship between the pharmacist and the patient, the dispensing and supervision of Methadone/Buprenorphine and the records that must be kept.

3.2 Dispensing pharmacies should maintain close links with the patient’s prescribing doctor and drug worker and should ensure that patients are aware of this. The code of ethics of the Royal Pharmaceutical Society of Great Britain (RPSGB) directs pharmacists to maintain patient confidentiality. However, patients should be made aware that in certain circumstances the pharmacist will communicate information about compliance and general wellbeing to the prescriber(see Appendix 1 point 19).

3.3A contract between the patient and the pharmacist will need to be signed (see Appendix 2). This clearly states agreed standards for both the patient and the service they can expect to receive.

3.4Where possible arrangements should be made for prescriptions to be delivered direct to the pharmacy.

3.5Supervision should take place in a quiet, private area and never in the dispensary.

3.6The pharmacist on duty must fulfil their legal and professional responsibilities as detailed in Appendix 3

3.7Pharmacists and their staff should have the appropriate level of training to undertake the service, including health and safety training on the handling of controlled drugs.

3.8The pharmacist on duty should have completed the CPPE distance learning pack, “Substance use and misuse (pharmacists)” and have the competencies detailed in the Drug and Alcohol National Occupational Standards (DANOS 2005)(see for DANOS Competencies AH8: Dispense medicines and products).

3.9 In the event of the pharmacy named in 1.1using locum pharmacists

in an emergency situation to provide the service, they should also be working towards completing the CPPE distance learning pack, “Substance use and misuse (pharmacists)”

3.10A copy of this agreement must always be available for the pharmacist in charge.

3.11In accordance with the controlled drug regulations 2006, the service provider is required to notify the PCT Accountable Officer about any concerns relating to controlled drugs.

4 Service Outline

4.1Where a prescription indicates the need for supervision or administration of a drug within a community-pharmacy a comprehensive service should be provided as follows:

4.1.1A user-friendly, non-judgmental, patient centred and confidential service

4.1.2The prescribed quantity should be provided to the patient for whom it was intended in a properly labelled closed container.

4.1.3The patient should consume the item in front of the pharmacist. Water should be available for the patient to drink to ensure the dose has been swallowed.

4.1.4Procedures should be followed to cover cases where patients have missed treatment for a number of days consecutively or if a patient attends the pharmacy intoxicated (see Appendix 1 point 19).

4.1.5Procedures should be followed in the event of unacceptable behaviour or difficult incidents, as outlined in the Community Pharmacy Patient Contract and patients should be made aware of these.

4.1.6Dispensing in specific instalments (doses may be dispensed for the patient to take away to cover days when the pharmacy is closed) in line with the local Supervised Dispensing Protocol (see Appendix 1).

4.1.7Patients should be made aware of local factors, such as opening times of individual pharmacies.

4.1.8Patients should be asked to sign a Contract prior to engaging in the scheme. If a patient refuses to sign a contract the service should not be provided.

4.1.9Dispensing and supply can be refused in certain circumstances, as defined by the Patient Contract (see Appendix 2).

4.1.10Advice and information should be provided to the patient, including referral to primary care, immunisation or specialist drug services, where appropriate. The DAAT will be responsible for providing up-to-date information.

4.1.11Encouragement and advice on how to register with a GP, if appropriate.

4.2For the purpose of this local enhanced service the following elements need to be in place:

4.2.1An accurate register of patients.

4.2.2Safe and secure premises, appropriate for the provision of such services.

4.2.3Close links with the prescriber ensuring that systems are in place to report the non-collection of doses where necessary.

4.2.4If 3 or more doses are missed, the prescriber will have to reassess the patient and review the prescription before reinstatement.

4.2.5Information available to enable locum pharmacists to continue to provide the commissioned services in line with the contractual requirements.

4.2.6A good knowledge of, and effective liaison with, the local relevant drug and alcohol services and other agencies, including non-statutory services. It is important to ensure that this knowledge is kept up-to-date.

5 Remuneration

5.1It is recognised that the supervision of Methadone/Buprenorphine is an additional professional service.

5.2This Agreement covers payments of £1.50 for Methadone and £3.00 for Buprenorphine per agreed supervision / per day during 2009/11 attendingthepharmacy named in 1.1 for the provision of supervision of Methadone/Buprenorphine an enhanced service, contained in Level 3 of the National Pharmacy Contract 2006/07.

5.3The investment will fund the above fee for patients attendingthepharmacy named in 1.1 in Staffordshire County with a prescription for supervision of Methadone/Buprenorphine from 1 September 2009 to 31 March 2011.

5.4Expenditure will be deemed ineligible in any of the following circumstances:

  1. recoverable input VAT incurred.
  2. expenditure supported from other government sources, local authority grants, or EC structural funds.
  3. expenditure on activities of a political or exclusively religious nature.
  4. any liability whether arising out of negligence or any other cause.

6Claims Process

6.1The pharmacy named in 1.1will submit the appropriate Dispensing Record Claim Form, see Appendix 5 detailing all work undertaken, by 15th of the following calendar month to the Staffordshire County Drug and Alcohol Action Team. Completion of all sections of the claim form, including the unique prescription reference number, are mandatory. Notes for completion of the claim form can be found in Appendix 4.

6.2Claim Forms containing incomplete or incorrect data will not be processed and will be returned to the Contractor for re-submission with the next months return. Re-submitted Claims not received within this timescale will not be processed.

6.3Payment for claim forms will be made either by cheque or BACS via Staffordshire County Council. In the case of multiple pharmacy companies payments will be made by BACS payment direct to the head office. If multiple pharmacy groups operate as individual business units arrangements will be made for payments to individual pharmacies. For payment enquiries contact:

Julie Gardiner

Staffordshire County Drug and Alcohol Action Team
Leaven House

University Court

Staffordshire Technology Park

Beaconside
Stafford
ST18 0GE

Tel: 01785 358605 Fax: 01785 358606

7Performance Information

7.1It is the responsibility of the pharmacy named in 1.1 to maintain accurate records and financial records in respect of these payments for administrative and statistical purposes for a minimum of two years to ensure effective ongoing service delivery and audit.

7.2Representatives of the Staffordshire County Drug and Alcohol Action Team will undertake random annual audits of the supervised consumption scheme. This will involve the following:

  1. unannounced visits
  2. inspection of the private area
  3. completion of a questionnaire with the Pharmacist
  4. provision of a copy of the pharmacist(s) CPPE Certificate
  5. service user feedback on their experience of the scheme

7.3Staffordshire County Drug and Alcohol Action Team will undertake random checks of the Claim Forms submitted against patient dispensing records held by the prescriber to ensure probity of claims.

8Insurance and Indemnity

8.1The pharmacy named in 1.1shall ensure that they obtain adequate public liability and employer liability insurance, together with any other relevant insurance necessary in respect of this service.

8.2The pharmacy named in 1.1shall be liable for and shall indemnify the Staffordshire County Council (on behalf of the SCDAAT) against any liability, loss, claim or proceedings arising under any statute or at common law in respect of any damage to property or persons; any injury to persons including injury resulting in death; and any claim from a person, except where this is due to any act or neglect on the part of the Staffordshire County Council.

9Renewal of the Contract by Agreement

The parties may by agreement renew this contract on the expiry of the contract period. However, any such renewal shall:

  1. Be subject to the continued availability of any additional funding required by the Council to finance the purchase of all or part of the service.
  1. Be subject to the Council being satisfied:
  2. With the quality and performance of the service;
  3. That there is a sufficient evidence-based need for the service to justify the renewal of the contract;
  4. That the provision of the service during the contract period has been consistent with the Council’s statutory duty to secure best value.

3.On the same terms and conditions as this contract, subject to any amendments which shall be agreed between the parties.

4.Be subject to the Council first securing any necessary waiver or approval in accordance with the requirements of its contract standing orders.

1Supervised Methadone/BuprenorphineScheme

Signature Page for provision of service from

1 September 2009 – 31 March 2011

Please ensure that the pharmacy name, address and contact details are provided in1.1

Commissioner

Signed for on behalf of the

Staffordshire County Drug and Alcohol Action Team

Print…………………………………

Signed………………………………

Title…………………………………..Date………………………………..

Provider

Print…………………………………

Signed………………………………

Job Title ………………………………….Date…………………………………

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APPENDIX 1

Local Supervised Dispensing Protocol

  1. The prescribing doctor will agree with each new patient and the pharmacy participating in the scheme the pharmacy by whom Methadone/Buprenorphine will be dispensed, and the drug worker will notify the pharmacy accordingly
  1. The daily dispensing and supervision of Methadone/Buprenorphine is only one aspect of a broader harm minimisation strategy. Patients may be undergoing stabilisation and may be attending the pharmacy every day - this service should therefore be as discreet as possible and the patient treated with respect and courtesy
  1. All patients who are to receive daily Methadone/Buprenorphine should agree and sign a patient contract. If the patient is new, the pharmacist on duty should explain the contract and countersign it. A copy of the contract should be given to the patient, together with a pharmacy practice leaflet
  1. The pharmacist should ensure that all new patient details are entered on the appropriate Dispensing Record Claim Form (see Appendix 5)
  1. The pharmacist should ensure that the counter staff are aware, so that the patient can be dealt with promptly each day
  1. When a prescription is presented, the pharmacist should check that the prescription is legally correct and that the patient has an existing contract with the pharmacy
  1. Daily doses may be prepared in advance and stored in the Controlled Drugs cabinet, to avoid undue delay when the patient presents in the pharmacy

Daily doses should be prepared as follows:

  1. Measure, double-check and dispense in suitable container
  1. Attach dispensing label to container detailing patient name, directions, quantity and date of dispensing
  1. Ensure that any ‘take home’ doses are fitted with child-resistant closures
  1. The pharmacist should mark the date and quantity supplied on the prescription at the time of collection. Leave blank when doses have not yet been prepared
  1. The prescription should be initialled at the time of collection / supervised self-administration
  1. Unless a ‘take home’ dose is required, the Methadone/Buprenorphine must be consumed on the premises under the supervision of the pharmacist or pre-registration pharmacist.
  1. This should take place in a quiet, private area: it should never take place in the dispensary. The pharmacist must be satisfied that the dose has actually been swallowed, either by observing water being swallowed after the dose, or by conversing with the patient to ensure that the Methadone/Buprenorphine is not retained in the mouth.
  1. All containers should be discarded after self-administration.
  1. All daily dispensing must be entered in the CD register on the day of supply.
  1. Supervised Methadone/Buprenorphine dispensing should allow sufficient time for the preparation of the day’s doses - and finish sufficiently early to permit the completion of dispensing records. (see Appendix 2 point 2).
  1. All occasions on which a patient fails to attend should be recorded on the attached claim form.
  1. The prescribing doctor should be contacted by telephone in any of the following circumstances:
  • Following three sequential failures to attend
  • Breach of the patient contract
  • Unacceptable behaviour when visiting the pharmacy
  • Evidence of increasing health, emotional or other problems
  • Requests for help that the Pharmacist is unwilling or unable to meet
  1. A copy of this protocol should be included with any briefing given to locum pharmacists brought in to cover holidays or other absences.
  1. For further information guidance please refer to the “Pharmaceutical Care for Substance Misusers / Guidelines for Supervision of Methadone Buprenorphine ” as produced by Staffordshire County Drug & Alcohol Action Team, PCT’s, LPC’s, Community Teams and Lloyds Pharmacy which will be forwarded to each pharmacy on receipt of a signed contract by the DAAT.

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APPENDIX 2

Community Pharmacy Patient Contract

Pharmacy Details:

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  1. All doses of Methadone/Buprenorphine will be dispensed daily. If a day is missed you cannot collect an extra dose on the following day. Each dose must be taken in the pharmacy under the supervision of the pharmacist. Doses can only be taken home to cover days when the pharmacy is closed. You should check the pharmacy opening hours.
  1. You may collect your dose at any time between ……….. in the morning and …….. in the afternoon.
  1. When you come to collect your prescription, please let one of the assistants know. You will be seen promptly, where possible, to save you waiting in a queue every day.
  1. Whilst waiting to receive your methadone, please take a seat or wait quietly in the main area of the shop.
  1. You will be given your dose of Methadone/Buprenorphine in a private area of the pharmacy. Your Methadone/Buprenorphine will be prepared in a closed container with your name and dose clearly marked for you to check. Please give the empty container back to the pharmacist. A drink of water will be provided and the pharmacist may ask you to speak to demonstrate that the Methadone/Buprenorphine has been swallowed.
  1. Any unacceptable behaviour while you are in the pharmacy will be regarded as a breach of this contract and no further prescriptions will be dispensed. Your prescribing doctor will be informed immediately.
  1. Examples of unacceptable behaviour include:
  • Coming to the pharmacy while under the influence of drink and/or drugs
  • Aggression or verbal abuse to staff or other customers.
  • Smoking in the pharmacy
  • Sending another person to collect your dose
  • Shoplifting
  1. If you miss your dose on more than 3 successive occasions you will need to start a new contract through the prescribing doctor who referred you.
  1. I have read and fully understand the above and wish to enter into a contract.

Signature ……………………….……. Patient Date …………………………

Signature………………………….Pharmacist Date ………………………….

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APPENDIX 3

Legal and Professional Responsibilities

  1. Ensuring the legality of the prescription and correctness of detail.
  1. Registering the patient onto the Patient Medication Record.
  1. Dispensing the medicine in accordance with the prescription system.
  1. Explaining that missed doses cannot be collected the next day.
  1. Following local agreed arrangements allowing the dispensing and supervised consumption of doses not collected on specified days – in accordance with Home Office guidance on instalment prescribing (Reference Pharmaceutical Journal Volume 274, number 7347, 30 April 2005 page 531).
  1. Pharmacy service providers cooperate with the chemist inspecting officer and the RPSGB inspector, as required by the professional code of practice (and future inspection bodies introduced following the Shipman Inquiry).
  1. Compliance with current legislation, including the Medicines Act 1968, Misuse of Drugs Act 1971, Misuse of Drugs Regulations 2001 as amended, Misuse of Drugs (Safe Custody) Regulations 1973, National Health Services (Pharmaceutical Services) Regulations 2005.

APPENDIX 4