NHSNottinghamCity Local Enhanced Service – Supervised Administration of Buprenorphine (Subutex)

Duration

The local enhanced service will run from1st April 2010 to 30th March 2011. A review will take place in January 2011.

Background

Current guidelines recommend all new treatment of opiate dependence be subject to supervised consumption for the first three months or a 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.

Pharmacists and their staff are well placed to alert other members of the health care team to a clients need for further support if appropriate.

Service description

  • This service will require the pharmacist to supervise the consumption of buprenorphine at the point of dispensing in the pharmacy, ensuring that the dose has been administered to the patient.
  • Pharmacies will offer a user-friendly, non-judgmental, client-centred and confidential service.
  • The pharmacy will provide support and advice to the patient, including referral back to primary care (prescriber), key worker or specialist centres where appropriate.

Aims and intended service outcomes

To ensure compliance with the agreed treatment plan by:

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

To reduce the risk to the local community of:

  • Over-usage or under usage of medicines;
  • Diversion of prescribed medicines onto the illicit drugs market; andaccidental exposure to the supervised medicines (Clients with children in Nottingham City PCT can be provided with safe storage boxes by their key workers).

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.

Quality Indicators

  • The pharmacy contractor shall comply with all the requirements of the essential services of the NHS Community Pharmacy Contractual Framework.
  • All pharmacists working within participating pharmacies must adhere to the guidelines of this service.
  • The pharmacy must have available PCT provided health promotion material available for the user group and actively promote its uptake.
  • The pharmacy must review its standard operating procedures and the referral pathways for the service on an annual basis.
  • The pharmacy contractor shall ensure that pharmacists employed to work in the pharmacy are accredited and have completed the CPPE training package- ‘Substance Use and Misuse’. A copy of the certificate of accreditation must be submitted to the PCT within 3 months of the start of service or by 31 July 2010 for pharmacy contractors renewing their SLA
  • Regular locums should be encouraged to complete the CPPE course ‘Substance Use and Misuse’ and to attend any PCT / CDP training events.
  • The pharmacy contractor shall ensure that pharmacists and staff involved in the provision of the service are appropriately trained, are aware of and operate within local procedures and guidelines. The pharmacy contractor shall also ensure that any paperwork relating to the service, local procedures and guidelines issued by the PCT are easily accessible in the pharmacy.
  • The pharmacy will undertake Significant Event Analysis of incidents (relating to the service) and demonstrate learning from incidents where required by the PCT relevant to the service.
  • The pharmacy will participate in an annual PCT organised audit of service provision, if requested to do so.
  • Participating pharmacists are required to attend annual PCT / CDP training events and review meetings if requested to do so.
  • The consultation area used for provision of the service must meet a sufficient level of privacy and safety.

Accreditation

Following an initial PCT training event, further training or review meetings for community pharmacists (in relation to opiate dependence and supervised treatment) may be arranged as required for exceptional or high priority issues.

Pharmacists may attend these events as part of their “Continuing Professional Development”. Pharmacists should update, maintain and develop their capabilities according to their own identified learning needs.

The named community pharmacist should undertake the most current Centre for Post Graduate Pharmaceutical Education (CPPE) course, ‘Substance Use and Misuse,’ or have completed training within 8 weeks of beginning to provide the service. The accreditation certificate should be submitted to the PCT on completion.

Payment Schedule

Date effective from: 01/04/2010

Date of next review: 31/03/2011

Payment per supervised dose of Subutex = £3.05

Monitoring and Review

It is important to continually monitor community pharmacy pharmaceutical service provision activity and to report on unresolved issues to the PCT.

Records of pharmacy activity will be reviewed by financial and professional audit by officers working for NHSNottinghamCity.

Adverse incident reports and complaints on service standards from clients will result in discussion with the individual pharmacist concerned.

Payments will be credited to the pharmacy contractor’s account by the end of the month following the submission of the monthly claim form to the administrator by the 5th of each month. There will be no payments made belonging to another financial year other than for supervision of doses carried out in March, which must be submitted during the month of April.

Payments will be credited to the pharmacy contractor after receipt of invoice and subject to requirements being met.

Serious Untoward Incidents

Contractors are required to have a robust incident reporting and investigation procedure in place for all clinical and non-clinical incidents. All significant untoward incidents (SUIs) should be recorded and reported to the PCT within the timeframes stated in the NHS East Midlands ‘Protocol for the Reporting and Handling of Serious Untoward Incidents in the East Midlands’.

Termination

NHSNottinghamCity or the pharmacy contractor shall give three months notice in writing for any agreed changes to the service agreement or termination of the agreement. This is to allow sufficient time for alternate arrangements to be made to ensure the continuity of service.

NHS Nottingham City shall be entitled to terminate this enhanced service agreement by notice in writing to the provider if the provider commits any continuing or material breach of any of the provisions of this agreement and, in the case of a breach capable of remedy, fails to remedy the same within 14 days after receipt of a written notice giving full particulars of the breach and requiring it to be remedied.

Equality and Diversity

The pharmacy will gather information on the following equality and diversity information which will be passed to the PCT as agglomerated data.

a)Ethnicity

b)Religion

c)Sexuality

d)Disability

Standards for Better Health Framework standards for incorporation into SLAs

The pharmacist will abide by the code of ethics and standards and professional requirements set by the Royal Pharmaceutical Society of Great Britain (RPSGB)

The pharmacy contractor will have due regard to promote equality and eliminate unlawful discrimination as set out in the Race Relations (Amendment) Act 2000, the Disability Equality Duty and the Gender Equality Duty.

The pharmacy contractor will ensure that all patients, carers and relatives are treated with dignity and respect. The pharmacy contractor will ensure that it meets the needs and rights of different patient groups with regard to dignity including by meeting the relevant requirements of the Human Rights Act 1998, the Race Relations Act 1976 (as amended), the Disability Discrimination Act 1995, the Disability Discrimination Act 2005 and the Equality Act 2006

The pharmacy contractor will ensure that the pharmacy premise is well designed and well maintained in order to promote effective care and optimise health outcomes. The pharmacy contractor should have made reasonable adjustments to tackle physical features that act as a barrier to disabled people from accessing the service.

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NHSNottinghamCity Local Enhanced Service – Supervised Administration of Buprenorphine (Subutex)

Parties and signatories to this agreement

Commissioner for NHSNottinghamCity

Signature:

Name: Samantha Travis, Senior Pharmacist – Clinical Governance Lead

Date:16thFebruary 2010

Community Pharmacy Contractor

For and on behalf of:

Name and address of community pharmacy:

Signature:

Name:

Date:

Samantha TravisFebruary 2010

Senior pharmacistReview date: February 2011

SUPERVISED CONSUMPTION SCHEME PROTOCOL

  1. When a decision has been made by a prescribing service regarding a patient who requires supervised administration, the prescriber will contact the community pharmacy to request and agree that the pharmacist dispenses for this patient.
  1. The prescriber may contact another pharmacy if the pharmacist that was contacted feels unable to supervise a particular individual due to previous problems (e.g. theft or violence)
  1. The prescribing service should stress the following to the patient:
  2. The patient attends the pharmacy to receive their doses within agreed times as stated in their CIS (Client Information Sheet).
  3. The patient lets the pharmacist know if they are unable to attend.
  4. The patient refrains from causing unnecessary problems and does not behave violently or aggressively towards the pharmacist or pharmacy staff.
  1. Patients will be referred back to the prescribing service if:
  • The patient requests a change to their prescription.
  • The patient attends the pharmacy under the influence of alcohol and drugs.
  • The patient fails to collect his drug for three consecutive days.
  1. All prescriptions will be clearly marked “for supervised administration.”
  1. The patient’s Key Worker will liaise with the pharmacist on an ongoing basis.
  1. The pharmacist will communicate information about the patient, including failure to attend regularly, unacceptable behaviour, improper use of medication and obtaining supplies of other addictive drugs to the prescribing service or Key Worker.
  1. The Senior Pharmacist – Clinical Governance lead will meet bi-annually with the participating pharmacists, representatives of the LPC and PCT to discuss policy issues.
  1. The Senior Pharmacist – Clinical Governance lead will keep all participating pharmacists up-to-date regarding any development of the service and will supply an up-to-date list of participating pharmacies together with relevant details (i.e. consultation areas etc) on a six monthly basis or more frequent if appropriate to the prescribing services, all community pharmacies and to the LPC.

SUPERVISED CONSUMPTION OF SUBUTEX - GUIDELINES FOR PARTICIPATING PHARMACIES

  1. All patients who are to receive daily-supervised dose should agree and sign a Client Information Sheet (CIS) given by the pharmacy. If the patient is new, the pharmacist should explain the contents of the CIS. A copy of the CIS is to be given to the client together with a practice leaflet. The pharmacist should also keep a copy of the signed CIS for their own records.
  1. Agree with the patient the most appropriate time period for them to attend and receive their medication. Ensure that information relating to weekends and Bank Holiday doses are provided.
  1. The pharmacist should also introduce the patient to the counter staff so that the patient can be recognised and dealt with promptly each day.
  1. The pharmacist should ensure that all new patient details are entered on the Patient Medication Record (PMR). Minimum data should include name and address, date of Birth, GP/prescriber details, ‘supervised consumption’, key worker and contact number and any other therapy the patient is receiving.
  1. A PMR card with the patient ID number may be issued – this will be useful for locum pharmacists brought in to cover holidays and absences.

The pharmacist must ensure that the intended dose is given to the right client (i.e. Check name, address, DOB, ask to see identification etc).

  1. When a prescription is received, check that the prescription is legally correct and that the patient has an existing agreement with the pharmacy. In the case of new patients, make sure the prescriber has already contacted the pharmacy to arrange and agree the ‘supervised consumption’ of this patient. If a new patient presents with a prescription and you have had no contact with the prescriber, contact the prescriber to inform them of the whereabouts of the prescription.
  1. Daily doses should be prepared in advance and stored in the Controlled Drugs cabinet to avoid undue delay when the patient presents in the pharmacy.
  1. Pharmacists must fully dispense and label individual instalments- ensuring daily recording on the PMR. If this involves a mixture of strengths, it must be separately labelled in accordance with standard ‘best practice’ procedures. The pharmacist should mark the date and quantity dispensed on the prescription at the time of dispensing.
  1. Check that the patient has been given and has read the Subutex patient information leaflet and warning card re: analgesia.
  1. A drink should be made available for clients who may require it before dosing to moisten the mouth or after the tablet has completely gone to refresh the mouth. A drink should NOT be offered during dosing. Clients should dispose of their used cups in a bin provided for them. Pharmacy staff should not handle the used cups. Clients should not be allowed to bring opened containers of drinks into the pharmacy.
  1. The pharmacist should check the name, quantity and dose on the label(s) before giving the client the dose.
  1. Unless a “take-home” dose is required, the Subutex must be consumed on the premises under the direct and continuous supervision of a pharmacist. This should take place in a quiet, private area; it should NEVER take place in the dispensary. The pharmacist either pops the tablet out of the blister pack into a named or disposable pot or directly into the patient’s hand. The pharmacist must ensure that the tablets are placed under the tongue and left to dissolve.
  1. The pharmacist or a suitably trained member of the dispensing team will then directly supervise the consumption, observing the client continuously and ensuring that the patient swallows as little as possible in that time. This is because any swallowed drug is inactivated. The patient should be continuously observed for as long as the dose is being consumed (up to a maximum of 5 minutes).
  1. The PCT should be contacted if pharmacists wish to nominate other members of the dispensary team to take over supervision once the pharmacist has handed the client the dose and ensured it is in place under the tongue. On site training will be arranged for nominated staff.
  1. The patient should remain in the pharmacy until the tablets are in an indistinguishable form.
  1. Before leaving, the patient must satisfy the pharmacist that the tablet(s) has/have dissolved and has not been concealed in the mouth. What remains is a chalky residue that can be swallowed. The pharmacist should look under the patient’s tongue and converse with them. If the client refuses to co-operate on this, record this down. If this happens on more than one occasion, the pharmacist should contact the key worker. Note: Clients may be reluctant if they have used heroin that day).
  1. The pharmacist should then initial the prescription at the time of collection/supervised self-administration.
  1. No entries are required in the CD register but it is good practice to record each supply on PMR.
  1. If the patient refused the dose, treat as a returned CD, i.e. destroy and make a record of this and record on the prescription what dose has been taken and what has been discarded.
  1. If necessary at weekend and bank holidays, a Subutex tablet should be consumed on the day of collection of the take-home dose. Ensure a patient information leaflet is given with a supply.

Notes:

1.The summary of product characteristics states that the tablet will dissolve in five to ten minutes. In practice it has been found that this takes two to four minutes.

  1. Do not give Subutex to a patient following three consecutive failures to attend the pharmacy. They must be referred to the prescriber for assessment.

3.This service should be as discreet as possible and the patient treated with respect and courtesy at all times.

  1. The prescription should not be dispensed to clients who are intoxicated with drugs and/or alcohol. If it is suspected that the client is intoxicated, the clinic should be informed and the client referred to the clinic. If this occurs on a Saturday, the pharmacist should not dispense. If this occurs early in the day, the client should be asked to return later in the day, when they are no longer intoxicated. The pharmacist should record any advice given to clients in situations such as this (If the pharmacy is not contracted to open during the weekend and the client is intoxicated on a Friday, the clinic should be contacted).
  1. Whilst dispensing to the patient the pharmacist should make a brief assessment of the patient’s general well being/status/mood and report back any problems to the patient’s Key Worker. Please note all occasions on which the client fails to attend on the Patient Supervision Record Form. Complete the patient’s supervision record/details and indicate whether the dose was supervised, dispensed, refused or missed.
  1. The prescription must not be given to the patient’s representative unless previously agreed and authorised by the prescribing agency/clinic and agreed with the pharmacist. In this case, a separate letter should be obtained on each occasion a supply is made to the representative and the pharmacist must ensure that the letter of authority is genuine.
  1. The Patient’s PMR should include all other prescription items, and where appropriate, other over-the-counter medication supplied.
  1. All patient information, must be kept in a secure place, and must not be passed on to anyone other than those authorised to see it. Data Protection Act 1998 must be complied with. Pharmacists should make sure that all staff members are aware of patient confidentiality issues.
  1. It is recommended that participating Pharmacists receive Hepatitis B vaccination which should be available from the Pharmacist’s own GP. Currently, this is at the expense of the pharmacist’s employer.
  1. Locum pharmacists should be kept informed of the service provided prior to commencement of their duties and a copy of this dispensing guideline to be included with any briefing given to locum pharmacists.
  1. At the end of each month a monthly claim form should be completed and sent to the scheme administrator by the 5th of each month.
  1. If more than one tablet is to be supervised the client should be advised to put the tablets under the tongue simultaneously.

Client Information Sheet