Service Level Agreement for the Enhanced Pharmaceutical Service Administration of Medication Between Turning Point & PHARMACY
This document sets out a service specification for a community pharmacy supervised consumption service to be provided by the contractor to service users who are prescribed methadone or buprenorphine and will encompass supervised support and advice to service users in a safe environment. For the purpose of this Service Level Agreement (SLA) supervised consumption means the observed consumption, by the pharmacist or a trained pharmacy staff member, of prescribed substitute medication for opiates where supervision has been requested by the prescriber. The practice is designed to support service users to stop or stabilise their opiate use thus enabling them to develop their personal goals. The aims and objectives of this service are: To ensure the safe consumption of substitute medications for opiate misuse by patients To minimize the diversion of controlled drugs, which thereby contributes to a reduction in drug related deaths in the community To support patients in adhering to treatment regimens that will enable them to reduce the harm caused by illegal drug use To offer a professional user-friendly, non-judgmental, client-centered and confidential service To monitor and offer advice to the service user on their general health, well being and sign post accordingly Compliance from all parties will form an integral part of the SLA and determine whether it is renewed or terminated on an annual basis. Parties to the Agreement This agreement is made between: Turning Point Wakefield & District Treatment Service The Community Drug Team 2 nd Floor, Grosvenor House 8-20 Union Street Wakefield WF1 3AE who provides drug misuse services under contract to the Wakefield MDC. and; Pharmacy: the Chemist Contractor Address:
Agreement Period 1. The agreement will commence on and expire 31/03/15, unless terminated earlier by either party subject to appropriate notification. 2. The agreement may be terminated without penalty if any party gives the other party one month s written notice. Purpose of the Agreement. 3. The Agreement is for the supervised administration of medication, namely methadone and buprenorphine to service users of the Treatment Agency by accredited Pharmacies. 4. There will be no reimbursement for dispensing any other medication, unless agreed prior to dispensing by the treatment service and pharmacist. Treatment Services Responsibilities 5. Services will take responsibility for establishing and monitoring pharmacy accreditation including inspection of pharmacy premises, up to date SOPs and pharmacist s drug misuse qualifications (training) etc. 6. To liaise closely with the Pharmacists and the service users. 7. The treatment provider will ask the service user which of the participating pharmacies they wish to attend, rather than direct them to a particular pharmacy. 8. To advise Pharmacists when a new service user is to have supervised medication, ensuring the pharmacy is contacted immediately prior to the service user accessing the pharmacy. 9. Workers will inform service users that doses must be taken under the direct supervision of the Pharmacist or trained assistant working under their supervision. 10. The treatment provider may choose to establish a basic Service User Contract which will include standards of behaviour etc. (Example shown in Appendix 1). 11. Pharmacists may establish their own additional contract if they wish. 12. Visit the accredited pharmacy periodically (at least once per year) to facilitate liaison and review the SLA and consultation area. 13. Treatment providers will report incidents appropriately to SPECTRUM (prescribing agency) and with consent to NHS England.
Pharmacy Contractors Responsibilities 14. Pharmacists will liaise closely with the Treatment Services. 15. A qualified Pharmacist or Locum must be present each day; no dispensing can take place in their absence. 16.The Pharmacy will notify the relevant service and keep a record of: Any changes of pharmacy ownership or regular pharmacy manager Any patients not attending for three days for any medication All errors that relate to prescriptions provided by the treatment provider or that affect the Service user All incidents that relate to prescriptions provided by the treatment provider or that affect the Service user 17.Service users will be treated with a supportive, understanding and professional attitude. The service should be as discrete as possible and service users treated with respect and courtesy. a. Pharmacists may reasonably refuse to accept service users e.g. where someone has previously created difficulties, but a valid reason must be supplied and reported to the treatment provider immediately b. Pharmacists will contact the relevant service and / or the police where fraud is suspected (the conditions specified in the Terms of Service of Pharmacists [NHS Regulations Schedule 1, Part 2, Part 9] relating to refusal to supply drugs also apply) c. The pharmacists are to report service user behavioural incidents to the relevant project on the following contact numbers: Wakefield 01924 377704 Castleford 01977 517422 South Kirkby 01977 642611 DIP/ DRR 01924 334300 Shared Care 01977 665713 If this is out of hours a message should be left and followed up on the next working day. E-mails must not be used for reasons of confidentiality. d. To check scripts and inform the relevant project of any missing scripts or queries that may arise. This must be done on the day the Pharmacy receives the scripts. e. All scripts must be stored securely in an allocated place that all Pharmacy staff are aware of. f. An additional Service User Contract may be established between the Pharmacy Contractor and the service user if the pharmacy so wishes. Whether or not this is done, the pharmacy should ensure that the service user is fully aware of what is expected while in the pharmacy. g. Reasonable steps must be taken to aid identification of service users and minimise potential error. Service users should be asked for their name, date of birth and current dosage when necessary to confirm the
identity of the patient. In practice, it is anticipated that permanent pharmacy staff will also be able to identify regular service users to assist locums. h. The pharmacy will establish a Standard Operating Procedure (SOP) for supervising administration, the minimum components of which are attached (Appendix 2). A copy of the SOP will be made available to Turning Point on request where appropriate. i. This scheme is restricted to community pharmacies with NHS England Wakefield District that are accredited to provide the service only. In order to become accredited, the pharmacy must have suitable structural facilities, including a consultation room, which must be used for all supervised consumption. In the temporary absence of the accredited Pharmacist, the service may still be provided by a locum pharmacist accompanied by another member of staff who has been trained and is aware of the pharmacy SOP. j. In the interest of service user confidentially and choice, service users must always primarily be offered the use of a private consultation room for consumption of their medication. Only at the instigation of the service user and with the pharmacy staff agreement should consumption occur elsewhere in the pharmacy, i.e.; hatch.. It is appreciated that due to time issues service users requiring supervised Buprenorphine may be supervised in another area of the pharmacy once they have the tablets in place under their tongue. k. For pharmacists to gain accreditation, they must have successfully completed either the College of Post Graduate Pharmacy Education distance learning package for drug misuse, or the Pharmaceutical Aspects of Methadone Prescribing course issued by the Scottish Centre for Post-Qualification Pharmaceutical Education. All appropriate pharmacy staff should be trained in compliance with the SOP.. l. The service should be available from accredited pharmacies for at least part of the six days per week, but five days per week may be considered at the discretion of the Treatment Service. Therefore most pharmacies must offer the service for at least forty hours per week and one hundred hours for the pharmacies registered under the hundred hour exemption criteria. 18. To have an up to date SOP for Supervised administration in place that all relevant staff have been trained on. 19. Supervision fees for service users attending other treatment services may be paid by Turning Point; should this occur the pharmacist should contact Turning Point with full details of the person, medication, length of supervision and originating treatment service prior to claiming payment.
Financial Terms 20. The monthly claim for payments must be completed as required and returned to Turning Point by the dates indicated. Incomplete or illegible paperwork will be returned and remain unpaid until corrected. 21. Payments for participation in the scheme will be made to the relevant chemist contractor at the following rates: a) Supervision 1.50 per administration of Methadone. 3.00 per administration of Buprenorphine. b) Poured, but cancelled (methadone) 1-00 TOTAL per patient per cancellation. c) All prices are fully inclusive of VAT. Signed on behalf of Pharmacy Contractor Signature Date. Designation. Signed on behalf of Turning Point Wakefield & District Treatment Service (Turning Point) Signature Date. Designation
APPENDIX 1 (for information) N.B. There are 3 similar Turning Point Service user Contracts, one for simple daily collections, one for actual supervision and one for buprenorphine dispensing. TURNING POINT SERVICE USER CONTRACT I.. agree to (1) My medication being supervised from Pharmacy. I understand that the pharmacist may stipulate a special time. Prescriptions will be delivered to the pharmacy. (2) Attend all appointments at Turning Point at given dates and times. If you fail to attend an appointment your prescription may be suspended. (3) Attend regular appointments with the prescribing GP. (4) Be responsible for the prescription once it has been collected. It will not be replaced if it has been lost, stolen or used up early. For methadone prescriptions that are on a daily pick-up it is the responsibility of the service user to collect their own medication. Missed pick-ups will be reported to Turning Point and may result in loss of prescribing. (5) Give a urine sample when appropriate and when asked to do so. Urine testing will be unobserved Any falsifying of urines may result in loss of prescribing. I understand that this service will be discontinued if I behave badly or present under the influence of alcohol and/or drugs in either the Pharmacy, Turning Point, the Surgery, or in the Community with anyone associated with Healthcare. Signed: Date:..
TURNING POINT SERVICE USER CONTRACT I.. agree to Collect my Buprenorphine from Pharmacy. 1. I understand that the pharmacist may stipulate a specific time for collection and prescriptions will be delivered to the pharmacy. 2. Attend all appointments at Turning Point at given dates and times. 3. See the prescribing doctor when my worker feels is necessary. 4. Be responsible for the prescription once it has been collected. It will not be replaced if it has been lost, stolen or used up early. 5. For Subutex prescriptions that are on a daily pick-up, it is the service users responsibility to collect their own medication. Missed pick ups will be reported to Turning Point and prescribing may be suspended. This could result in the loss of prescribing. 6. Give a urine sample when requested to do so. Urine testing will be unobserved Any falsifying of urine may result in loss of prescribing. I understand that this service may be discontinued if display inappropriate behaviour or present under the influence of alcohol and / or drugs in the pharmacy, Turning Point, The Surgery or in the community with anyone associated with Healthcare. Signed: Date:
APPENDIX 2 Standard Operating Procedure For the Supervised Administration of Medication N. B. Guidance/Checklist ONLY Minimum Standards for Adaptation by Individual Pharmacies N.B. This SOP will need to be reworded for each individual pharmacy. 1. General 1.1. Service users should be treated in a professional manner with dignity and respect at all times. Normal standards for dispensing and patient confidentiality apply. 1.2. Arrangements to ensure that appropriate measures to maintain good hygienic practices must be in place and monitoring should occur to ensure that these are being followed. This may be part of the existing pharmacy SOP. 1.3. The need for Hepatitis vaccination should be considered on an individual basis taking account of the local circumstances under which the supervision of medication will be taking place. 1.4. The pharmacist holding the contract must ensure that ALL staff are fully conversant with the SOP and the part that each of them may play. This is especially so in the case of locums who must be prepared to undertake the service as described in the SOP. 2. Preparing Medication 2.1. Daily doses may be prepared in advance (and stored in the controlled drugs cabinet) to avoid undue delay when the service user presents in the pharmacy. 2.2. Medication should be measured, double-check and dispensed in a suitable container. 2.3. Normal dispensing labels detailing service user name, directions, quantity and date of dispensing etc. should be attached to the container. 2.4. 'Take home' doses must be fitted with child-resistant closures in accordance with RPSGB guidelines. In the interests of safety, the use of other closures should be discouraged wherever possible. Comments about leakage if containers are not maintained upright should not normally be taken as sufficient reason not to use a childresistant closure. Where, exceptionally, a service user specifically requests that a childresistant closure is not used and this is considered appropriate, they should sign a suitable record to confirm the request. In such situations it is important that advice is given to keep the medication in a secure place and out of the reach of children. 2.5. Each labelled container will be sealed in a dispensing bag in which case this should be clearly marked with the service user's name/address and the day and date when the dose is due to be dispensed. 2.6. Add an 'S' or other suitable mark in bold print to the container or bag, to indicate that doses must be supervised. 2.7. The instalment section on the prescription form should be completed at the time of supervising.
3. Supervising Medication 3.1. When the service user presents in the pharmacy, they should make themselves known to a member of staff and wait quietly to be seen. The patient should state their name, date of birth and current dosage when necessary to confirm their identity. 3.2. If the Pharmacist has concerns that it would not be appropriate or possibly dangerous for the service user to take their medication (e.g. drunkenness, if it is suspected that the service user has been taking opiates illegally or where missed doses may have affected tolerance) they may wish to decline to supply. Before doing so, pharmacists are advised to make every effort to contact the prescriber and also to assess the relative harm which may result from the refusal. They should then use their professional judgement to decide what course of action would be in the best interests of the patient. Pharmacists may also refuse to supply if subjected to or threatened with violence or if the service user or person accompanying that person, commits or threatens to commit a criminal offence in keeping with Paragraph 9 of the Terms of Service of Pharmacists contained in Part 2 of Schedule 1 to the NHS Pharmaceutical Services Regulations 2005. 3.3. The medication must be consumed on the premises under the supervision of the Pharmacist or other appropriately trained person working under their supervision. Supervision of the dose should take place in a private consultation room at the pharmacy (please refer to item 17 j of the SLA). The Pharmacist must be satisfied that the dose has actually been swallowed. The service user should be provided with the labelled bottle so they can check their dose before they drink it. They may choose to take their dose straight from the labelled bottle but if preferred they should be provided with a disposable cup so they can pour the methadone from the bottle into the cup for consumption. 3.4. Dispensing from bulk supply straight into cups and presenting this to the service user contravenes the Medicines Act in regard to requirements for labelling of dispensed medicines. It is important to distinguish the two steps of dispensing the medication and supervising the service user self-administration. 3.5. When supervising the administration of methadone, the Pharmacist or other appropriately trained person working under their supervision should observe the service user drink their dose and should offer the service user a drink of water afterwards. Initially, many service users dislike the taste of the methadone and a drink of water not only helps but also ensures that they swallow their dose. If the service user doesn't wish to have a drink, then swallowing can be confirmed by ensuring that conversation also occurs at this time. The water should be provided fresh from a supply suitable for drinking. 3.6. Buprenorphine tablets should be prepared in advanced and packaged as outlined above. The supervising pharmacist or appropriately trained assistant should administer the dose from the container (or blister) onto the service user s palm. The service user should then pick up the tablets with their finger and thumb and place them into their mouth. The tablets should be placed under the tongue the service user should be observed at all times until the supervisor is satisfied that consumption is complete. 3.7. All containers should be discarded after self-administration in a way which avoids illicit reuse. Where necessary, labels should be removed or defaced. 4. Recording 4.1. All daily dispensing must be entered in the CD register on the day of supply. 4.2. Pharmacists should consider the need for a record form to be completed at the time of supervision to show the service user's name and the date/time of day that a supervised administration has taken place. This may be important to ensure that doses are not inadvertently repeated later in the day, particularly when another Pharmacist might be involved. Service users may need to be asked to countersign the record if there is any
possibility that they may contest that they have not been given their due medication. N.B. For reasons of confidentiality and security, one service user must not be able to see records relating to another service user, so it may be necessary to use individual pages in a record book. 4.3. A diary should be maintained to record any unacceptable behaviour on the part of the service user. 5. Premises 5.1. A suitable, quiet area of adequate size and which affords reasonable privacy in audible and visible terms must be provided and maintained. The area should be capable of being used for purposes other than simply the supervision of medication (e.g. confidential discussions with other patients about their medication). This will avoid stigmatising service users who use it and is also in the interests of cost-effective use of space. 5.2. The confidential area should be maintained in a good state of decoration and have suitable lighting. A supply of drinking water should be available in the immediate vicinity with facilities for the storage of disposable cups e.g. automatic dispenser fixed to a wall. 5.3. A chair should be available so the service user has the option of being seated. On the basis that the area will be used for other activities, it will be appropriate to make provision for additional seating for at least a second person and wheelchair access. A table should be provided unless a similar facility is available such as a low-level counter. High-level counter arrangements will not be considered acceptable since they do not provide for adequate patient interaction when giving advice and information. 5.4. Attention must be given to the need for security combined with the level of pharmacist/service user contact necessary.. Signed by pharmacist and ALL staff who may be involved in any aspect of the operation of the SOP... Precise arrangements will be dependent on local circumstances and, if appropriate, may be agreed through consultation with the Treatment Agency.