SERVICE SPECIFICATION FOR COMMUNITY PHARMACIES
PROVIDING A SUPERVISED CONSUMPTION SERVICE FOR
METHADONE AND BUPRENORPHINE
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:1.
2.
3.
4.
5.
6.
7.
8.
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.
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2. The Dispensing Process
When a patient requiring supervised consumption of methadone or buprenorphine
presents a prescription, the pharmacist should:
2.1
Confirm that the legality of the prescription and the dose and the patient’s details
are correct.
2.2
Produce 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)
2.3
Advise and provide a leaflet to the patient on their first visit on the safe storage of
methadone in the home.
2.4
Consider 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:
3.1
The supervised consumption procedures comply with the guidance contained in
the latest edition of the RPSGB ‘Medicines, Ethics and Practice’.
3.2
The identity of the patient is confirmed before the dose is supplied.
3.3
Supervision is discreet, efficient and mindful of the patient’s dignity.
3.4
The 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.
3.5
The dose of methadone is measured and transferred into a disposable cup or
suitable container (e.g. medicine bottle) prior to consumption.
3.6
After 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.
3.7
Doses 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.
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4. Supervised Consumption of Sublingual buprenorphine Tablets
In preparation for and when supervising the consumption of buprenorphine, the
pharmacist should ensure that:
4.1
The supervised consumption procedures comply with the guidance contained in
the latest edition of the RPSGB ‘Medicines, Ethics and Practice’.
4.2
The identity of the patient is confirmed before the dose is supplied.
4.3
Supervision is discreet, efficient and mindful of the patient’s dignity.
4.4
The patient does not enter the dispensary area of the pharmacy.
The consumption should take place in another location in the pharmacy,
preferably the consultation area, if available.
4.5
The sublingual buprenorphine tablets (still in their blister packs) that constitute
the dose should be transferred into a suitable receptacle prior to consumption.
4.6
The 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.
4.7
The patient should be offered the opportunity to check the name, strength and
quantity of tablets before they are removed from the blister pack.
4.8
The 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.
4.9
The tablet should be placed under the tongue by the patient and left to dissolve.
The active ingredient is absorbed through the buccal mucosa.
4.10
The tablet should not be swallowed, as it is not effective if taken this way.
4.11
The summary of product characteristics states that the tablet will dissolve in five
to ten minutes.
4.12
The 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.
4.13
It 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.
4.14
The 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.
4.15
Doses 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.
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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:
5.1 Key workers must develop and maintain close links with the prescriber and the
pharmacists. In particular:
1
Arranging or helping the client to arrange for a local pharmacy willing
and able to undertake the supervised consumption enhanced service.
2
Being available to assist the pharmacy with any client problems.
3
Monitoring the client’s progress with the treatment and recording any
significant incidents which may occur in the pharmacy.
4
When 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.
5.2
The 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).
5.3
The 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.
5.4
In pharmacies where regular locums are employed they should be strongly
encouraged and supported to gain accreditation or attend training.
5.5
Any noteworthy incidents or events should be recorded on the patient’s PMR. If
the professional judgement of the pharmacist is that the 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:
6.1
The patient has failed to turn up for two doses (see appendix 4).
6.2
Whole doses are not consumed under supervision.
6.3
A patient attempts to avoid supervision.
6.4
The patient exhibits threatening, violent or other inappropriate behaviour.
6.5
The patient appears to be ill or there has been a noticeable decline in the
patient’s health.
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6.6
There is a problem with the prescription.
6.7
At the request of the patient for a clinically important matter.
7. Record Keeping
Following each supervised consumption, pharmacists should make an appropriate entry
1. In the CD register
2. On the prescription
3. 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.
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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.
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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.
5.4 Attach 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.
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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, semiprivate 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 the named patient, except in the
following circumstances.
10. Doses may only be issued to a representative:
o at the pharmacist’s discretion,
o if exceptional and occasional circumstances occur,
o 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 and
needle 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.
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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.
3. 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.
4. 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 pharmacies who have appointed an accredited
pharmacist to act as lead for this service will be entitled to claim payment for
providing this service.
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The Contractor
f)
(Page 2 of 3)
Pharmacists participating in the project agree to abide by the guidelines laid
down in the Community Pharmacy Standard Operating Procedure for the Service
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.
5. 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.
b) Payment will normally be made for up to 3 months of supervision per patient
in accordance with the recommendations in the National Treatment Framework.
Authorisation by the LHB will be required to allow a patient to have more than 3
months of supervision funded.
c) The monthly payment is divided into 4 equal portions, the pharmacy may claim
the weekly fee if the client attends for at least 1 supervised consumption in that
week.
5.2. Payment Terms
A claim (Form A) for the number of patient supervised must be sent monthly by
the accredited pharmacy to the Finance Dept or the relevant LHB. Claims may be
subject to post payment verification.
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Commencement Date
(Page 3 of 3)
st
This Service Level Agreement (SLA) takes effect from 1 September 2009 to 31st March
2010.
Agreement Review
The LHB and the accredited practicing pharmacists will review the content of the
agreement to agree service requirements for 2010/11, and in the following year to agree
service requirements for 2011/12. Either party can make reasonable changes to the
service requirements at the reviews.
Latest date for review:
31st March 2010
Signed for and on behalf
Pharmacy address ……………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Name of accredited Pharmacist …………………………………………………………….
Signature ………………………………………………….
Date……………….
Designation ……………………………………………….
Signed for and on behalf of Flintshire LHB
Name……………………………………………………..
Signature …………………………………………………
Designation ………………………………………………
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Date……………….
Appendix 3: Patient Supervision Contract (Page 1 of 2)
You are now being prescribed a regular prescription by your GP or Specialist Doctor
which requires you to visit the pharmacy daily (except Sundays and bank Holidays). We
will provide this service on condition that you accept the following.
ATTENDANCE TIME
1
I have agreed with the pharmacist that I should come to the pharmacy for my
medication at
………… … … am, or at ………… … … … pm
2
I realise that I should not arrive within the first thirty minutes of opening and that I
should be at the pharmacy (chemist) no later than thirty minutes before closing time.
Once closed, the pharmacy will not reopen under any circumstances.
MEDICATION
1. I accept that I am required by my doctor to consume my medication under the
supervision of a pharmacist in a ‘quiet’ area of the pharmacy. I will be required to
suck slowly (Subutex™) or wash down with water (methadone), and talk to the
pharmacist to show that it has been swallowed.
2. I understand that the methadone will be given to me in a closed bottle with my name
and dose clearly marked for me to check. The dose may then be poured into a
suitable container for me to drink.
3. I understand that if I miss my dose I will not be allowed to collect an extra dose on
the following day. My supplies for day(s) when the pharmacy is closed will be
supplied in an appropriately sealed and labelled container.
4. I agree that my daily dose will not be issued to any other person.
5. It is my responsibility to ensure that I have a current prescription and to plan and visit
the doctor when necessary. I agree that my doctor, key worker and pharmacist may
share information relevant to my medication.
6. I realise that supplies will not be re-issued under any circumstances whatsoever.
7. I confirm that I am currently addicted to opiate drugs. I understand that the
medication can cause serious harm or death in overdose. I recognise that
methadone/Subutex™ and benzodiazepines e.g. temazepam, diazepam are
addictive and may cause drowsiness. If affected I know I must not drive or operate
machinery. I know they are dangerous when taken with alcohol.
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BEHAVIOUR
(Page 2 of 2)
1. I understand that it is in my best interests to be absolutely truthful about my drug use.
2. I agree to come into the store unaccompanied to collect my medicines personally
and promptly at the agreed time.
3. I will not come into the pharmacy under the influence of alcohol or other drugs and I
understand that drinking alcohol and smoking on the premises is forbidden.
4. I will let one of the staff know each time I arrive to pick up my medication so that I
can be dealt with promptly.
5. I understand that the pharmacy may refuse to supply my medicines if I am suspected
of any misdemeanour within the establishment and that my GP will be informed and,
if necessary, the police will be called.
I have read the terms of this contract, have been given a copy and understand what they
mean. I agree to abide by them and understand that if I do not, my doctor will be
informed.
Signed ………………………………………….. Date …………………………...(patient)
Full name ……………………………………………………………………………
(patient)
My GP or my medical consultant is Dr ………………………………………………
Address: ……………………………………………………………..
Key Worker Name… … … … … … … … … … … … … … …… … ……… …… ……
Address: ……………………………………………………………..Tel No… … … … … … .
………………………………………………………………………………………………………
Pharmacy Address … … … … … … … … … … … … … … … … … … … … … … … ...
Tel No … … … … … … … … … …
We agree to treat you with humanity and respect if the above are observed, and agree to
support you through your period of treatment.
Signed ……………………………………… … … … …
(Pharmacist)
Date ………………………....
Full Name …………………………………………………………………………...
Original to be retained in the pharmacy
One copy to patient along with Practise leaflet
Third copy for key worker (CPN or other)
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Appendix 4: Missed Daily Doses Protocol
This protocol is to advise Community Pharmacists on dealing with situations where
patients request a daily dose of substitute medication when preceding day(s) have been
missed. It is a North Wales Protocol and has been agreed by Specialising GP’s,
Consultants and NHPS pharmacist.
Protocol
If the patient or representative fails to attend for their daily prescription, then the following
protocol would apply, unless otherwise directed.
1) Day one missed dose of a daily prescribed substitute for a dependency drug be
ignored and the service re-commence the following day.
2) Day two of a missed dose incident be treated as suspicious, but if the pharmacist
agrees, then the supply is to be made on the following day assuming a good
explanation is made. Key worker to be informed on day two.
3) Day three of a missed dose incident indicates that at the professional discretion of
the pharmacist, no further supply will be made until the patient has contacted either
the prescriber or key worker.
4) The Prescriber him/herself is to inform the relevant pharmacy (by fax or telephone) of
their intentions regarding continued treatment. There must be written instructions
if dispensing is to continue. It is assumed that the prescribers will have intervened in
the matter in order to resolve the issue. The pharmacist will no longer be held
responsible for any unforeseen circumstances resulting from continuation of
treatment after the three day delay.
5) Suitable records of such communications should be held at the pharmacy.
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Byrddau Iechyd Lleol
Gogledd Cymru
North Wales Local
Health Boards
Appendix 5: Claim Form A – Supervised self- administration of Methadone/
Subutex™(Page 1 of 2)
Please submit these forms by the 10th of the month following the month of the claim. Please forward completed forms to
your Local LHB Contractor Services Team; Medicines Management Team, Flintshire LHB, Preswylfa, Hendy Road,
Mold, Flintshire. An audit trail of claims is available at the premises, and the information on these claims may be subject
to random validation by the LHB or authorised officers. Action may be taken if the claims are seen to be incorrect.
Claim for the Month of ………………………………… Year …………………
Payment will be based on the total number of patients requiring supervision per week. I
declare that for the above month:(a) There is a written procedure available for locums on supervised
arrangements
(b) The service complies with the pharmacy service specification
(c) The total number of weeks Subutex™ supervision is………………….
(d) The total number of weeks Methadone supervision is………………
Name of LHB accredited Pharmacist in Charge of this service …………………………………..……
Signature ……………………………………………
Date … … … … .
The details of the supervisory Pharmacists are:
Name
Signature
Contractor Name ………………………………………… BSC Account Number….…………………
Contractor address or Stamp (must be legible)
LHB/BSC USE ONLY
LHB Financial code ______________________
Checked for payment by __________________
Authorised by _____________________________
Date_____________
Checked by BSC __________________________
Date_____________
Paid by BSC _______________________________
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Summary of monthly Supervision activity for all Clients (Page 2 of 2)
Claim for the Month of ………………………………… Year …………………
Number
of
different
clients
PMR Number or
Subutex™ Methadone Number of
Patient Identifier for Clients
Total
supervisions
of
each client (as used (Details
volume
strength and
on claim form B)
supplied
total number
Number of
weeks
supervisions
claimed for
supplied)
e.g.
123654
10 x4mg
n/a
1
2
3
4
5
6
7
8
9
10
Totals
Contractor address or Stamp (must be legible)
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9
2
Byrddau Iechyd Lleol
Gogledd Cymru
North Wales Local
Health Boards
Appendix 5:Supervised self-administration of Methadone/Subutex™ record
form B (This form is to be retained in Pharmacy)
Name of Client………………………………… Name of Pharmacy.………………………………..
Month…………………………
Year………………..
PMR Number or Patient Identifier ………………………………………………
Day
Date
Pharmacist
Initials
Amount of Methadone
(mls)/ Subutex (mg)
Comments
e.g. problems encountered
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
This form may be subject to post payment verification checks
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