INTRODUCTION
The North Wales Community Safety Partnership acting on expert advice has developed a local strategy for the treatment of patients who are dependent on drugs of abuse. A key component of this strategy is to commission from Community Pharmacies a Supervised Consumption Service for Methadone and Buprenorphine (Subutex™).
GUIDANCE ON THE KEY COMPONENTS OF THE SERVICE
This document provides guidance on the following topics:-
- The patient contract
- The dispensing process
- Supervised consumption of methadone mixture
- Supervised consumption of buprenorphine sublingual tablets
- Professional relationships
- Examples of circumstances where a pharmacist should contact a prescriber
- Record keeping
- Training requirements for participating Pharmacists and staff
Appendix 1: Community Pharmacy Standard Operating Procedures Appendix 2: Service Level Agreement
Appendix 3: Supervision Contract
Appendix 4: missed daily doses protocol
Appendix 5: Claim Form A and B supervised self administration of methadone/buprenorphine.
1. The Patient Contract
It is important for pharmacies participating in this service to agree a ‘patient contract’ with each patient. This ‘patient contract’ should outline how and when the Supervised Consumption Service will be provided and the obligations of both the parties. The patient should be provided with a written copy. A duplicate copy should be retained by the Pharmacy and a third for the key worker. If appropriate the patient should be introduced to key members of staff.
2. The Dispensing Process
When a patient requiring supervised consumption of methadone or buprenorphine presents a prescription, the pharmacist should:
2.1Confirm that the legality of the prescription and the dose and the patient’s details are correct.
2.2Produce a record for each patient on the Patient Medication Record (PMR) System and to include key worker telephone number. The record should be updated as soon as possible following each dispensing/supervised consumption episode. Initiate a Claim Form B per client (see Appendix 5)
2.3Advise and provide a leaflet to the patient on their first visit on the safe storage of methadone in the home.
2.4Consider if the patient appears to be intoxicated or is otherwise incapacitated to such an extent that dispensing the dose would place the patient at risk of harm, and if necessary refuse to dispense the dose of methadone or buprenorphine
3. Supervision of Consumption of Methadone Mixture
In preparation for and when supervising the consumption of methadone, pharmacists should ensure that:
3.1The supervised consumption procedures comply with the guidance contained in the latest edition of the RPSGB ‘Medicines, Ethics and Practice’.
3.2The identity of the patient is confirmed before the dose is supplied.
3.3Supervision is discreet, efficient and mindful of the patient’s dignity.
3.4The patient does not enter the dispensary area of the pharmacy.
The consumption should take place in another discreet location,
preferably in the consultation area, if available.
3.5The dose of methadone is measured and transferred into a disposable cup or suitable container (e.g. medicine bottle) prior to consumption.
3.6After swallowing the dose of methadone the patient is required to swallow some water or juice in order to demonstrate that the methadone has been swallowed, or to engage in conversation satisfactorily.
3.7Doses of methadone for days when the pharmacy is closed, should be dispensed in child-resistant containers and labelled appropriately to include the day of consumption.
4. Supervised Consumption of Sublingual buprenorphine Tablets
In preparation for and when supervising the consumption of buprenorphine, the pharmacist should ensure that:
4.1The supervised consumption procedures comply with the guidance contained in the latest edition of the RPSGB ‘Medicines, Ethics and Practice’.
4.2The identity of the patient is confirmed before the dose is supplied.
4.3Supervision is discreet, efficient and mindful of the patient’s dignity.
4.4The patient does not enter the dispensary area of the pharmacy.
The consumption should take place in another location in thepharmacy,preferably the consultation area,if available.
4.5The sublingual buprenorphine tablets (still in their blister packs) that constitute the dose should be transferred into a suitable receptacle prior to consumption.
4.6The patient must have a drink of water or juice before the dose to moisten the mouth. In such cases, provision must be made for safe disposal of drinking cups. Patients should not be allowed to bring opened containers of drinks into the pharmacy.
4.7The patient should be offered the opportunity to check the name, strength and quantity of tablets before they are removed from the blister pack.
4.8The pharmacist should remove the tablet out of the blister pack, so that it goes directly into the patient’s hand or into a small disposable pot.
4.9The tablet should be placed under the tongue by the patient and left to dissolve. The active ingredient is absorbed through the buccal mucosa.
4.10The tablet should not be swallowed, as it is not effective if taken this way.
4.11The summary of product characteristics states that the tablet will dissolve in five to ten minutes.
4.12The patient should not leave the pharmacy until the pharmacist or a delegated trained member of staff is sure that the tablet has dissolved. Once dissolved, what remains is a chalky white residue that can be swallowed.
4.13It is not necessary for the pharmacist to watch the patient continuously since the pharmacist is only responsible for ensuring that the tablet goes into the mouth, is placed under the tongue and then confirming with the patient that the dose has been absorbed.
4.14The pharmacist must be satisfied that the patient has not concealed the tablet in the mouth. This can be done either by conversing with the patient or asking the patient to swallow some water.
4.15Doses of buprenorphine for days when the pharmacy will be closed, should be dispensed in child-resistant containers and labelled appropriately to show the day of consumption.
5. Professional Relationships
It is essential that there are effective communication links between the various professionals involved in the care of patients receiving methadone and buprenorphine substitution therapy. In particular:
5.1Key workers must develop and maintain close links with the prescriber and the pharmacists. In particular:
1Arranging or helping the client to arrange for a local pharmacy willing
and able to undertake the supervised consumption enhanced service.
2Being available to assist the pharmacy with any client problems.
3Monitoring the client’s progress with the treatment and recording any significant incidents which may occur in the pharmacy.
4When a patient receiving daily methadone or buprenorphine is admitted or discharged from hospital it is essential that the community and hospital pharmacists should liaise closely to share information.
5.2The prescriber should contact the pharmacist and key workers with patient details as soon as a new patient has been identified as requiring a methadone or buprenorphine consumption services.A list of locally available pharmacies
should be held by the appropriate LHB (this information needs to be shared across LHBs and with other appropriate organisations).
5.3The accredited pharmacist should make, in advance, appropriate arrangements to inform locums of the procedure to be followed when providing methadone and buprenorphine supervised consumption services. Accreditation is preferred.
5.4In pharmacies where regular locums are employed they should be strongly encouraged and supported to gain accreditation or attend training.
5.5Any noteworthy incidents or events should be recorded on the patient’s PMR. If the professional judgement of the pharmacist is thatthe prescriber or key worker should also be informed (Appendix 4 Missed dose protocol) then the pharmacist should do so within an appropriate time-scale. Serious issues of an urgent nature must be communicated immediately to the prescriber.
6. Examples of when the Pharmacist should contact the Prescriber
The pharmacist should contact the prescriber or key worker if:
6.1The patient has failed to turn up for two doses (see appendix 4).
6.2Whole doses are not consumed under supervision.
6.3A patient attempts to avoid supervision.
6.4The patient exhibits threatening, violent or other inappropriate behaviour.
6.5The patient appears to be ill or there has been a noticeable decline in the patient’s health.
6.6There is a problem with the prescription.
6.7At the request of the patient for a clinically important matter.
7. Record Keeping
Following each supervised consumption, pharmacists should make an appropriate entry
- In the CD register
- On the prescription
- On the Claim form B (Appendix 5). One sheet per client per month
8. Payment claims
The pharmacy should complete the supervision claim form (form A) the end of each month and forward to their LHB.
The agreed monthly fee will be divided in to 4 equal amounts (weeks), the pharmacy should claim for the number of weeks or part weeks that a client accesses the supervision service for. i.e. if a client only attends for supervision on 9 occasions the pharmacy should claim 2 weeks of fees.
9. Education & Training for participating pharmacists
Pharmacists wishing to provide Methadone and Buprenorphine Supervised Consumption Services should have:
Undertaken appropriate underpinning knowledge training e.g. WCPPE distance learning pack “Substance Use and Misuse”. Certificate of completion to be submitted to the Health Board.
Attended a WCPPE training evening “Introduction to supervised consumption” - not essential, but recommended.
Completed the “Knowledge self assessment module”(in addition to the questions in the distance learning pack), details obtained through the WCPPE websites National Enhanced Services section, or by telephoning the WCPPE on the usual number. Once completed and passed, submit your three year date expiring certificate to the Health Board.
In addition Complete the “Generic skills knowledge self – certification form” available from the WCPPE and submit this to the Health Board.
Pharmacists are also expected to undertake CPD appropriate to this service.
Bibliography.
1.”Clinical Guidelines on the Management of Substance Misuse”. Published jointly by the Department of Health and the Welsh Office in 1999. This guidance advises that; in most cases, all new patients being prescribed methadone should be required to take their daily dose under the direct supervision of a professional for a period of time which may, depending on the individual patient be at least 3 months, subject to compliance.
2.” Tackling Substance in Wales- a Partnership Approach”. Published by the Welsh Assembly Government in May 2000. This strategy advises that in order to improve treatment well managed methadone administration services should be provided.
Appendix 1:North Wales Supervised Methadone/Subutex™ Consumption Scheme
Community Pharmacy Standard Operating Procedure (Template)
1. The pharmacist on duty should explain the contract to all new patients who are to receive daily medication (methadone/Subutex™). The patient should agree and sign the patient contract. This should be countersigned by the pharmacist. A copy of the contract should be given to the patient, together with a practice leaflet.
2. The pharmacist should ensure that all new patients are entered on the Patient Medication Record (PMR). Minimum data should include name and address; date of birth, GP, supervised/unsupervised and any other therapy the patient is receiving from that pharmacy.
3. The pharmacist should introduce the patient to the counter staff, so that the patient can be dealt with promptly each day. A PMR card with the contract number may be issued- this is useful if someone (in emergency situations only) other than the patient is collecting the supply, or in the case of supervised medication if the locum does not know the patient.
4. When a prescription is presented, check that the prescription is legally correct and that the patient has an existing contract with the pharmacy.
5. 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.
Daily doses should be prepared as follows:
5.1 Measure, double check and dispense in a suitable container,attach dispensing label to container detailing patient name, directions, quantity and date of dispensing. This labelling of container is a legal requirement.
5.2 Ensure that any ‘take home’ doses are fitted with child-resistant closures.
5.3 Seal each labelled container in a dispensing bag, with the patient’s name and address label attached. Clearly mark the bag with the surname in bold and the day and date when the dose is to be dispensed/consumed.
5.4Attach the prescription to the bag, then store the bag in the controlled drug cabinet until the client calls to take their medication.
5.5 The instalment section of the prescription should be completed with the date and quantity measured, at the time of dispensing.
5.6 Immediately following the methadone/Subutex™ being supervised /collected, the pharmacist must enter the supply details in the controlled drugs register and initial the instalment section of the prescription.
5.7 If after preparing and labelling the daily dose of methadone/Subutex™ the client fails to attend, the pharmacist must amend the PMR to show that no supply was made.
6. The patient’s identity must be checked and the pharmacist satisfied prior to the dose being issued. The supervision process should take part in a quiet, approved, semi-private or private area and never take place in the dispensary.
7. The quantity and details of the dose should be checked against the prescription, it should then be poured into a suitable container for consumption. 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 medication is not retained in the mouth.
8.Uncollected doses will be forfeited.
9. All doses must be personally collected by thenamed patient, except in the following circumstances.
10. Doses may only be issued to a representative:
- at the pharmacist’s discretion,
- if exceptional and occasional circumstances occur,
- only on presentation of a signed, dated mandate.
11. If the pharmacist considers the patient’s behaviour to be unacceptable, the patient appears intoxicated, or the pharmacist has any concerns, the prescriber should be contacted immediately and the dose withheld.
12. The pharmacist should make any locums who may be asked to provide this service in their absence aware of the protocol before they are employed. There should also be a senior member of staff who is able to assist them in identifying the client.
Locums should preferably have undergone specific training for this enhanced service.
13. All staff providing services to drug mis-users such as supervised consumption andneedle exchange should be offered Hepatitis B vaccination. Training should be given to maintain a safe working environment emphasising the need to avoid exposure to blood and other body fluids and to avoid needle stick injuries.
14.On any occasion where the pharmacy is forced to close and the service cannot be provided, then every effort should be made to contact the client and prescriber to advise them that other arrangements will need to be made.
Note: The daily dispensing and/or supervision of methadone/Subutex™ is only one aspect of a harm minimisation strategy. Many patients are on a long-term maintenance treatment and will be calling into the pharmacy every day, this service should, therefore, be as discreet as possible and the patient treated with respect and courtesy.
Appendix 2: Service Level Agreement for Community Pharmacies Providing a Supervised Consumption Service for Supervised Methadone/Subutex™(Page 1 of 3)
1.Parties to the Agreement
This agreement is between: ……………………………………………………………
(Please complete)
……………………………………………………………
And
Flintshire Local Health Board
2.Purpose of the Agreement
This agreement relates to the enhanced pharmacy service for the provision of a supervised consumption service for patients receiving prescriptions for methadone and buprenorphine.
- Agreement Period
The agreement will commence on 1st September 2009 until 31st March 2010. It will be subject to renewal if agreed by all parties.
The agreement may be terminated, without penalty, if either party gives the other party three months notice in writing.
- Obligations
LHB
a)The LHB will accredit suitable pharmacies. In general these will be pharmacies that have or are willing to develop a satisfactory counselling area. This is an area where a client can consume their medication discreetly.
b)The LHB will enter into a Service Level Agreement with each accredited pharmacy that can appoint a named pharmacist to provide the service.
c)The LHB will provide training where necessary for pharmacists to be accredited for the service in accordance with the service level agreement.
d)The LHB will manage the scheme in accordance with the service level agreement.
e)The LHB will ensure that all pharmacieswho have appointed an accredited pharmacist to act as lead for this service will be entitled to claim payment for providing this service.
The Contractor (Page 2 of 3)
f)Pharmacists participating in the project agree to abide by the guidelines laid down in the Community Pharmacy Standard Operating Procedure for theService specification for community pharmacies providing a supervised consumption service for methadone and buprenorphine.
g)Participating pharmacists must agree a patient contract for each new supervised methadone/Subutex™ client.
h)Pharmacists must complete the training as outlined in the service specification.
i)Participating pharmacists will receive payment each month for each client who is having supervised self-administration of methadone/Subutex™ on satisfactory receipt of claim forms.
j)All pharmacists are required to maintain the confidentiality of information obtained in the scheme. The information is confidential to the Prescriber and the individual Community Pharmacist. Non-confidential client details (edited copy) are for Local Health Board, National Public Health Service and Business Service Centre use.
- Terms and Fees
5.1.Payment for Professional Services
a)A payment of £52.68 will be made for each full month of supervision for Methadone patients, and a fee of £70.86 will be paid for each full month of supervision of Buprenorphine. In the event of agreement of a new national rate; the LHB will adjust the rate in accordance with the nationally recommended rate.