Download Surrey Supervised Consumption Scheme Operational Policy March

Surrey Supervised Consumption
Scheme
Operational Policy
March 2010
1
CONTENTS
Page 3
Contacts
Page 4
Introduction
Page 7
Guidelines for participating in the scheme
Page 8
Shared Care Partners
Page 9
Roles and Responsibilities
Page 10
Guidelines to the Shared Care Contract
Page 11
Sample Shared Care Contract
Page 12
Supervised Consumption Procedure – Prescriber Role
Page 13
Sample Prescription
Page 14
Supervised Consumption Procedure – Pharmacist Role
Page 18
Monitoring, Evaluation and Audit
Page 18
Other Pharmaceutical Issues
Page 21
Health & Safety
Page 22
Termination of contract between pharmacist and patient
Page 23
Appendix 1 – Remuneration for Pharmacists
Page 24
Appendix 2 – Community Pharmacy Contract
Page 25
Appendix 3 – Record Form
Page 26
Appendix 4 – List of medication for supervision
Page 27
Appendix 5 – Harm Reduction and Drug Treatment
Page 29
Appendix 6 – Monitoring, Evaluation and Audit
Page 30
Appendix 7 – Advice for Locum Pharmacists
2
Contacts
Surrey PCT
Susie Dadlani
Substance Misuse Manager
Surrey PCT
Ana Rodriguez
Substance Misuse Administrator
Surrey Harm Reduction Outreach Team
Parkview Centre for the Community
Blackmore Crescent,
Sheerwater, Woking, Surrey,
GU21 5NZ
Tel: 01932 355533
Fax: 01932 350963
Contract and Paperwork
All contracts and paperwork should be returned to:
Surrey Supervised Consumption Scheme Manager
The Outreach Team
Parkview Centre for the Community
Blackmore Crescent
Sheerwater
Woking
Surrey, GU21 5NZ
3
INTRODUCTION
The Supervised Consumption Scheme
In April 1999, the Department of Health published ‘Drug Misuse and Dependence –
Guidelines on Clinical Management’ which was circulated to all UK GPs. This followed
government white papers and health service guidance emphasising the importance of
primary care professionals in the care of drug users. Included in the guidelines is the
recommendation that patients should initially be supervised consuming their daily
methadone at the point of dispensing, which has meant a greater involvement for
pharmacists.
‘the traditional boundaries that enclosed health care professionals have been
broken down. The future is clearly about co-operation between health
professionals to ensure that the public receives the highest standards of care’.
(Royal Pharmaceutical Society of Great Britain – Annual Report 1999)
Currently these guidelines are for those pharmacists who are willing to supervise the
consumption of methadone, buprenorphine or buprenorphine/naloxone whilst working in
conjunction with the patient, the prescriber and the key worker. The Scheme may
expand to include other medication at a later date to separate specific contracts.
(See Appendix 4)
THIS POLICY WILL BE REVIEWED ANNUALLY
The Scheme is intended as a more closely monitored course of treatment aimed at
immediate harm reduction with the ultimate goal of abstinence wherever possible. The
improvement in communication and working relations between professionals will provide
further support for the treatment programme within shared care arrangements.
Every effort is being made to make process as ‘trouble-free’ as possible for the
prescriber/key worker and the pharmacy team. The PCT will contract with the pharmacy
contractor to provide supervised consumption for a period of 12 months (or part thereof)
from the start of each financial year. The pharmacist will receive payment for each
supervised dispensing at the flat rate set by the PCT (see Appendix 1 for further details).
Remuneration will be for recognition of the involvement of the professional parties in the
project. Pharmacists will undertake to provide 13 weeks supervised self-administration
for each patient. Supervision can be longer if all parties continue to be assured that
treatment is progressing.
Supervised consumption of methadone, buprenorphine or buprenorphine/naloxone is
only one aspect of harm minimisation strategy. Patients will be calling into the pharmacy
every working day – this service should therefore be as discreet as possible and the
patient be treated with respect and courtesy. This will also help to increase a patients
‘sense of worth’ and improves the chance of a successful outcome.
Patients given methadone, buprenorphine or buprenorphine/naloxone to take away
cannot always be relied upon to consume it. Doses can end up being shared or sold on
the black market. Supervised consumption is seen as one way round this problem. It is
important that once a patient is stabilised, they are trusted to accept a degree of
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responsibility by extending treatment to the introduction of ‘take home’ doses, for
example, from daily to twice weekly.
The pharmacist should accept that supervision might need to be re-instated in times of
crisis or relapse and should not consider this as failure of the programme.
An optimised Methadone Service
The National Treatment Agency for Substance Misuse has highlighted four crucial
elements for an optimum methadone service from an evidence base:
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Adequate doses following proper individualised assessment are important. Daily
doses of 60mg to 120mg have been shown to be effective
Services with adequate supervision and monitoring of patients including care
planning and supervised consumption (during initial stages or periods of instability)
are more effective in reducing harm and improving outcome
Services that strongly encourage involvement on psycho-social services have better
outcomes
Services with competent staff who can develop positive relationships with patients
have better outcomes.
NTASM:
Injectable heroin (and injectable methadone).
treatment. Executive Summary May 2003.
Potential role in drug
Government recommendations acknowledge that patient compliance with the
programme is an important issue in substance misuse treatment. Non-compliance with
treatment may lead to:
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Increased heroin use with associated risks for the patient, particularly overdose
Leakage of methadone, buprenorphine or buprenorphine/naloxone into the illicit
market.
The issue of leakage of methadone, buprenorphine or buprenorphine/naloxone into the
illicit market is one of serious concern. Methadone is dangerous in overdose and it has
been suggested that opiate overdoses are not always from people in treatment. It is in
the nature of drug dependence that many drug users find control of their drug use
difficult. For these people, daily supervision goes some way towards resolving this
problem and restricts supply of illicitly bought drugs.
It has shown that systematically linking incentives (in the form of relaxations in
instalment dispensing) to objective signs of progress may lead to increased stability and
reduced illicit drug use. In implementing this service, it must be recognised that this is a
measure not considered appropriate for the treatment of other conditions and must be
implemented on a clinical rather than moral basis.
These guidelines form the basis of a Scheme to pay community pharmacists for
supervising
the
daily
consumption
of
methadone,
buprenorphine
or
buprenorphine/naloxone in Surrey. Pharmacists applying for payment under the
Scheme are required to comply with these procedures. Please note that nothing in
these guidelines changes the legal position of pharmacists to, at all times, work within
the requirements of the Misuse of Drugs Act (1971) and any subsequent legislation.
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The Provision of supervised Consumption
The Surrey Drug Action Team (DAT) fully supports the supervised self-administration of
methadone, buprenorphine or buprenorphine/naloxone within community pharmacy
premises. Pharmacists can choose whether to participate in the Scheme, as it is
optional, and should discuss the Scheme and this document with staff and locums,
before entering the programme. It is essential that the programme remains consistent
and that all those involved are committed to its goals.
Through regular contact, pharmacists can build relationships with patients, encourage
stable use of methadone, buprenorphine or buprenorphine/naloxone and give verbal
affirmation and feedback appropriate information to partners on the programme.
Confidentiality
Confidentiality and discretion are crucial factors in the programme. The RPSGB
Medicine, Ethics and Practice guidance states; ‘Consideration must be given to
providing adequate privacy in the pharmacy for patients self-administering medicines.’ If
there is no ‘quiet’ area, this must be explained to the patient, who can then decide
whether to nominate an alternative pharmacy. Only in extreme circumstances, as a
temporary measure, should supervision take place in the dispensary.
Should a patient within the Scheme request other services, particularly
needles/syringes, the right of patient confidentiality must be respected. Remember, this
programme is based on harm reduction. Such a request provides an ideal opportunity to
raise the risk of overdose – made more likely due to the patient’s use of mixed
substances. Patients should not be made to feel judged by any member of staff as this
could impede the effectiveness of the programme (see also page 7).
Should a patient ask to see your confidentiality policy, you will need to be aware of
where to locate relevant paperwork. All staff should be aware of the sensitive nature of
this treatment and the need to make the patient feel safe about privacy. Information is
passed on purely on a ‘need to know’ basis to others involved in the programme (see
Caldicott Report, 1997).
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GUIDELINES FOR PARTICIPATING IN THE SCHEME
Pharmacists who agree to take part in this extra service will be required to sign an
annual contract with the PCT, committing them to run the project in accordance with this
policy. The agreement will run from April – March and will be for 12 months (or part
thereof if joined after beginning of the year). Whilst this document covers all the
procedures for taking part in the Scheme, each pharmacy should have its own specific
standard operating procedure for the Scheme, an example of which is in the information
file.
Aims
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To improve consistency and quality of care to the patient
To achieve stability and harm reduction
To reduce the risk of ‘leakage and spillage’ of drugs liable to misuse into the
community
To ensure, as far as possible, only the patient consumes the product doses
To promote positive contacts with treatment services
To improve communication between prescriber, key worker and the pharmacist
To reduce the risk of drug related death.
Pharmacists signing the PCT agreement will be required to take part in training offered
by the PCT and to have completed or be undergoing the named CPPE distance learning
pack (ref: Training section).
7
SHARED CARE PARTNERS
‘Shared Care’ refers to the process of treatment of a patient, which includes a number of
professionals responsible for the medication and care package. Government guidelines
(1999) suggest ‘Shared Care’ is characterised ‘…by an enhanced information exchange
beyond routine discharge and referral letters’. All people involved in ‘Shared Care’ are
referred to as ‘partners’ and can consist of:


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The patient
The pharmacist
The prescriber
The key worker
Other relevant professionals.
Permission should always be obtained from the patient prior to any partners entering
into discussion with another partner. This should be in the form of a signed
confidentiality waiver (ref: contract).
Patients come into daily contact with the pharmacist, which allows for health promotion
advice to be given and the monitoring of patient compliance/stability. The agreement
about supervised consumption of methadone, buprenorphine or buprenorphine/naloxone
seeks to develop for pharmacists a more formal role in monitoring and review of
methadone patients. It is difficult to give hard and fast rules about what should be
discussed with the prescriber/key worker. The decision is a professional one, which
should be made after considering the risk to the patient of non-disclosure and the
damage that may be done to the supportive relationship between the pharmacists and
the patient.
Examples of feedback are:



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


Patient attends irregularly
Patient’s general well-being appears to have improved/deteriorated
Patient does/does not consume the whole dose under supervision
Patient appears intoxicated (patients stabilised on methadone should be alert and
coherent)
Patient on a titrating dose at the start of a supervised script fails to collect one
dose. (The increased dose designated for the next day may be enough to risk
accidental overdose)
Patient on a stable dose fails to collect up to three consecutive doses of
methadone/buprenorphine or on several occasions over a period of weeks (missing
doses may result in a drop in opiate tolerance with an increased risk of accidental
overdose)
There are problems concerning the prescription, e.g. ambiguity of dates for
dispensing
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ROLES AND RESPONSIBILITIES
The patient, prescriber, key worker and pharmacists agree to the following:





To treat people as individuals and accord them respect
To empower to make informed choices
To only discuss items relevant to them. They are bound by their own professional
codes of ethics to maintain this confidentiality
To ensure any written records are securely stored and that the Data Protection Act
covering computerised records is adhered to: Data collection will be anonymous
(according to the National Drug Treatment Monitoring System) to ensure individual
patients cannot be identified
To endeavour to ensure that prescriptions and prescribed medications are correct
and available at the proper time, providing patients attend appointments at the
correct time.
Pharmacists

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
















To fully respect the patients right to confidentiality
To keep any personal details in a secure place
To ensure all staff treat the patient with dignity and respect
To explain the arrangements for when the pharmacy is closed
To explain the ‘house rules’ of the pharmacy e.g. no dogs allowed/collection times
To order and prepare (whenever possible) medication in advance
To not keep the patient waiting unnecessarily for medication
To ensure that medication is only dispensed to the patient
To dispense according to the prescription e.g. missed doses cannot be dispensed at
a later date
To discreetly supervise consumption (e.g. no calling out your name/address)
To ensure that the patient is correctly identified
To provide drinking water before and after medication has been consumed
To prepare all doses in suitable containers and ensure the lids are sealed
To feedback to the key worker/prescriber on attendance and well-being
To advise, if asked, of feedback given to your key worker/prescriber
To provide details of needle exchange outlets in confidence
To explain the complaints procedure
To maintain full PMR records for each patient
To explain that if three consecutive doses are missed, the prescriber/key worker will
be contacted to determine whether or not to continue to supply
To ensure all paperwork is returned to the Scheme Co-ordinator (Susie Dadlani).
The Prescriber/Key Worker


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
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To complete the initial assessment and initiate a programme treatment
To ensure that the patient has nominated a pharmacy that is willing to participate in
the Scheme
To complete the relevant paperwork, which form the Scheme
To liaise with the pharmacist on the patients behalf
To confirm the patient is registered with a GP.
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GUIDELINES TO THE SHARED CARE CONTRACT
There will be four copies of the contract for each patient.

The prescriber/key worker will complete the patient’s name and the name of the
pharmacy from which the patient will collect his/her methadone, buprenorphine or
buprenorphine/naloxone

The prescriber/key worker will discuss the contents of the contract with the patient at
the first consultation

The patient and the prescriber will then sign the contract. The prescriber/key worker
will then remove the top copy to keep on file

The remaining three copies of the contract will be sent by post to the pharmacy. If
there are time constraints, the patient may deliver the contract. The pharmacist will
discuss relevant details with the patient and sign the contract

The pharmacist will keep one copy on file and give one copy back to the patient

The pharmacy copy of the contract should be kept in this procedure manual, for easy
reference, stored in alphabetical order. Ensure the name is clear and, when
appropriate, include on the contract, the date the supervision has started and
stopped. The contract should be stored in a secure place

The pharmacist will send one copy of contract to the supervised consumption coordinator (Susie Dadlani), in order for payment to be arranged. (Please ensure all
details are clearly readable on this copy)
For a patient who has preciously received a contract and is presenting a new
prescription, it may be worth reminding the patient of the agreement and asking if they
would like anything explaining again. Another copy of the patient information leaflet can
be given if appropriate.
10
SHARED CARE CONTRACT
I, the patient named below, understand and agree to the following conditions of treatment:
1. I will be prescribed methadone mixture, buprenorphine (Subutex) or buprenorphine /
naloxone (Suboxone) (delete as appropriate) for daily supervised consumption at an initial dose
of ……………………………………………………..
Special Instructions: ………………………………………………………………………
2. I will collect my prescription in person from the pharmacy named below, at the time arranged
between the pharmacist and myself
3. I will see my key worker/prescriber on a regular basis and keep all my appointments unless
previously agreed.
4. The following have the right to discuss my case and may wish to see me together if this is felt
appropriate: ……………………………………………………………………
5. If I am intoxicated, my pharmacist has the right to refuse to dispense my medication.
6. I will not be a nuisance, abusive, violent, aggressive or rude to the prescriber, key worker,
pharmacist, pharmacy staff or customers.
7. I will provide a urine sample for analysis when requested.
8. I am responsible for any medication which I am prescribed and if I should lose them or take
them other than as directed, they will not be replaced.
9. I understand that I can only obtain prescriptions from my named prescriber unless alternative
arrangements are made.
10. I understand that I have chosen the pharmacy named in this contract from which to collect my
prescriptions. This means that I cannot have my prescription dispensed by any other pharmacy
without renegotiating my contract with the prescriber and another pharmacy.
11. I understand that I must collect my prescription on the specified day. If I fail to collect a dose on
the specified day, I will not be able to collect that dose on a later day.
12. I understand that if I fail to collect my dose for three days or more, my treatment will be
reassessed.
TERMINATION OF CONTRACT
The prescriber has the discretion whether or not to continue to prescribe to a patient and any
abuses or non-compliance with this contract will result in a review of the situation. The pharmacist
has the discretion to review whether or not to continue to dispense and supervise consumption if
any abuse of the contract, staff or premises occurs. Patients have the right to terminate the contract
if they feel the other parties have failed to fulfil the term of the contract.
Name
Prescriber
Team (tick)
□ Access
□ GP
DOB
Signature
Contact No.
Date
Copy Type
□ Windmill
□ Acorn
□ Respond
□ Other specialist DA service (please specify)
Pharmacist
Yellow
Patient
Pink
Full Pharmacy
Address
The prescriber and patient will sign the contract; the top copy (white) should be kept in the
patient’s medical records. The other three copies will be delivered to the pharmacist who
will sign the contract, retain the yellow copy, return the pink copy to the patient and send
the green copy to the Supervised Consumption Scheme Manager:
Surrey Harm Reduction Outreach Team
Parkview Centre for the Community, Blackmore Crescent, Sheerwater,
Woking, Surrey, GU21 5NZ
(Please ensure all details have transferred to the green copy)
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SUPERVISED CONSUMPTION PROCEDURE
Prescriber Role
Choosing a Pharmacy:
The prescriber will discuss with the patient, the most suitable/convenient pharmacy, where
the pharmacist will supervise consumption. The prescriber must also explain to the patient
that the pharmacist will be required to inform partners as to the progress of treatment and
will include for instance, frequency of consumption and in general how stable the patient
becomes on their medication. As part of the prescriber/key worker contract, informed
written consent to such discussions taking place should be obtained. This is the nature of
the ‘shared care’ contract.
Contacting the Pharmacy:
The prescriber/key worker should contact the chosen pharmacy in advance in order to seek
permission by the pharmacist to accept a patient of supervised consumption. This can be
done over the phone.
Dispensing Arrangements:
The pharmacist needs to be informed of the dispensing arrangements prior to the patient
attending the pharmacy. This makes the process less distressing for the patient who
otherwise might be viewed with suspicion. The prescriber/key worker should verbally
inform the pharmacist of the dispensing arrangements with special conditions specified (e.g.
confirm the medication is in stock as sugar-free methadone may take longer to order). It is
good practice to send the pharmacist an introductory letter stating the name and address of
the patient, the dispensing dose, start and expiry date of the prescription, and the names
and contact details of ‘shared care’ partners. To save time, this letter can be faxed to the
pharmacy. It should be made clear to the patient starting a new prescription that it is best to
attend the pharmacy during clinic hours in order that any queries with the prescription can
be addressed.
Prescription Details:
Only prescriptions, which are legally written, can be legally dispensed and care should be
taken over getting them right. Prescribers must issue instalment dispensing on blue FP10
(MDA) forms. FP10 (MDA) forms must only be used for Schedule 2 drugs, buprenorphine
and buprenorphine/naloxone. Any changes to the prescription requirements will be
highlighted to all partners by the pharmaceutical advisor.
Writing the Prescription:
State the pharmacy name in the top left hand corner, which ensures only the nominated
pharmacy, can legally dispense. Supervised consumption takes place every day the
pharmacy is open with take-home doses for Sundays and back holidays if the pharmacy is
closed on those days. Instructions can include: ‘All doses to be consumed on the premises
whenever possible and washed down with a glass of water’, which clarifies the situation for
the patient. Strike through any unused part of the prescription. Hand writing exemptions
can be issued by the Home Office if more than 10 controlled drugs prescriptions a week are
written, but still, they must be signed and dated by the prescriber. The prescription should
state the total quantity being prescribed, the amount of each instalment and the intervals
between dispensing. See example overleaf:
12
Example of Instalment Dispensing
13
SUPERVISED CONSUMPTION PROCEDURE
Pharmacist’s Role
Communication:
 Pharmacists and prescriber/key worker agree which information is to be communicated
 Pharmacists to agree on a suitable time to discuss any issues that arise from treating
patients on the scheme
Introductions:
Prior to arrival of the patient, the pharmacist should check the details of the contract.
Supervision Area:
Clarify for the patient where the supervision will take place. Ideally, supervision should
never take place in the dispensary. Where possible, a designated area offering suitable
privacy should be selected in each pharmacy and used for this purpose as well as
discussing other sensitive issues with customers. No other person in the pharmacy should
be aware of what the patient is doing. Care is needed in making the patient comfortable
and not stigmatised. If the patient is not satisfied that it is suitably private or discreet, they
can elect to attend an alternative pharmacy.
Patient Contract:
Assuming the patient accepts the area of supervision as suitable; the pharmacist should
then verbally go through the contract with the patient and complete the pharmacy leaflet.
When agreed, the pharmacist will sign and return the patient copy to the patient.
The main issues to be covered are:
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What to do when the pharmacy is closed, e.g. Sundays and/or bank holidays
Missed doses cannot be dispensed at a later date
The pharmacist will be feeding back to the prescriber/key worker, the observed effect of
treatment on the patient
That said, the patient’s right to confidentiality remains and information given to the
prescriber is strictly on a ‘need to know’ basis
The patient can discuss with the pharmacist any issues arising on a daily basis without
fear of the prescriber being informed. There are exceptions to this such as child welfare
and serious health issues
Requests for injecting equipment are not reason enough to inform the prescriber/key
worker (Ref: Pg 6)
The prescriber/key worker will be contacted and methadone, buprenorphine or
buprenorphine/naloxone may not be dispensed if the patient has missed up to three
consecutive days’ doses
Methadone, buprenorphine or buprenorphine.naloxone might not be dispensed if the
pharmacist suspects there is evidence of drug and/or alcohol intoxication due to the risk
of overdose and the prescriber/key worker may be contacted as a result.
14
Staff
If appropriate, the pharmacist should introduce the patient to key members of staff.
The Prescription:
When a prescription is presented, it should be checked to see if it is legal and if the
quantities and patient details are correct. If the pharmacy has been indicated in the top left
hand corner, then check it is correct. The prescription should stipulate ‘supervised
consumption’.
Preparation of methadone:
Doses of methadone should be made up in advance each day (assuming the pharmacist is
in the possession of a current prescription). Methadone should be dispensed into an
appropriate child restraint container labelled in accordance with the requirements of the
Medicines Act. The correct date of dispensing e.g. the date of supply to the patient should
be shown on the label.
Storage:
The methadone, buprenorphine or buprenorphine/naloxone should be stored in the
controlled drugs (CD) cupboard until the patient attends. Patients should not witness the
removal or replacement of the container in the cupboard.
Dispensing:
When the patient arrives, the pharmacist must ensure that the patient is correctly identified
and receives his/her dose of medication. Supervised patients are highly sensitive to their
situation and care should be taken not to disclose to other customers their medication
details. Wherever possible, supervision should be conducted out of the public view, in a
place that is commonly used for private consultations generally. The methadone should be
consumed directly from the bottle or may be poured into a cup provided by the pharmacist.
The use of straws should be recommended as a means to promote hygiene.
Consumption:
The pharmacist must observe the consumption of the medicine by the patient. To ensure
the product is consumed, the pharmacist should provide some water for the patient to drink.
It is not suitable for the patient to drink something they have brought into the pharmacy.
Alternatively, engaging in conversation with the patient also proves the methadone has
been swallowed or the buprenorphine, buprenorphine/naloxone has been sublingually
dissolved and allows for enhanced pharmaceutical care to take place. Ask if the patient is
well or if they are experiencing any problems etc. When all the medication has been
consumed, the patient should return the bottle to the pharmacist. For specific guidance on
buprenorphine, buprenorphine/naloxone dispensing, please refer to Ref: Pg 16.
Documentation:
After each dispensing/supervision, the pharmacist should then make the appropriate entries
in the CD Register, on the prescription and the record form.
Processing for Payment of Prescription:
The prescription should not be processed for payment until after the last valid dispensing
date/or once expiry date has been passed.
Missed Doses:
If a patient fails to collect three consecutive doses, no further methadone, buprenorphine or
buprenorphine/naloxone should be dispensed without the agreement of the prescriber/key
15
worker. This is due to the risk of overdose once a patient’s tolerance to methadone has
been reduced. If three consecutive doses have been missed, the pharmacist should try to
contact the prescriber/key worker prior to the patient next attending the pharmacy. This
means that when the patient does attend, they can be advised immediately about their
prescription and will not have to wait around the pharmacy unnecessarily (regardless of the
decision to continue dispensing or not). Individual missed doses (one or two days) should
be documented on the record form. It is not necessary to alert the prescriber on that very
day. Use professional judgement and if you are concerned about the patient, the prescriber
will be pleased to hear from you. However, it may upset the patient’s overall progress on
the programme if they think you have been ‘telling tales’ behind their back.
Additional Guidance for Dispensing BUPRENORPHINE (Subutex) and
BUPRENORPHINE / NALOXONE (Suboxone)
Unit dose packaging allows safer and more convenient handling, but risks confusion of
strengths and difficulties in popping the tablet out of the blister if individual doses are
‘snipped’ dispensed and labelled. For this reason, some pharmacist’s currently dispensing
buprenorphine (Subutex) or buprenorphine/naloxone (Suboxone) have been dispensing the
total amount on the prescription all at once. Daily dosed for supervision are taken from
these packs without individual patient medication records (PMR) being made on the
computerised records.
However, the RPSGB legal department have stated that
pharmacists must fully dispense and label individual instalments-ensuring daily recording on
the PMR.
Buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) are Schedule 3
controlled drug and does not require entry into the CD Register. They are subject to
prescription writing and safe custody requirements for controlled drugs.

Buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) should be
prescribed in daily instalments (occasionally thrice weekly) for supervised consumption
on the correct form

The prescription should be marked with “Supervised Consumption”
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The daily dose should be dispensed and labelled appropriately before the patient arrives
(when a prescription is current). Sometimes this may involve a mixture of strengths,
which must be separately labelled in accordance with standard ‘best practice’
procedures
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The original prescription should not be processed for payment until it expires/is
completed
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The patient must have a drink of water before consumption to moisten the mouth.
Provision must be made for safe disposal of drinking cups to ensure cross infection does
not occur
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The pharmacist should pop the tablet out of the blister pack, either into the patient’s
hand or into a small disposable pot
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The tablet needs to be taken as a single dose (where possible)
16
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The tablet(s) should be placed under the tongue and left to dissolve. The active
ingredient passes through the buccal mucosa and produces its effect

The tablet should not be swallowed, as it is ineffective if taken in this way

The summary of product characteristics states that the buprenorphine (Subutex) tablet
will dissolve in five to ten minutes. The buprenorphine/naloxone (Suboxone) tablet will
dissolve in two to ten minutes

The patient should not leave until the staff are sure that the tablet is dissolved. Once
dissolved, what remains is a chalky residue that can be swallowed

It is not necessary for the pharmacist to watch the patient continuously – the pharmacist
is only responsible for ensuring the tablet goes into the mouth, under the tongue and
then confirming with the patient that the dose has been absorbed

The pharmacist must be satisfied (either by conversing with the patient, water being
swallowed or other means) that the medication has not been concealed in the mouth.
Specific guidance for the use of buprenorphine for the treatment of opioid dependency in
Primary Care, produced by the Royal College of General Practitioners, will be provided by
the PCT.
17
MONITORING, EVALUATION AND AUDIT
As part of the RPSGB Standard 14 of Good professional Practice, it states that
documentation must be maintained to enable the regular monitoring of the service. One of
the roles of the co-ordinator will be to ensure the scheme is successful in achieving the
anticipated benefits. In January 2009 the Scheme, including the operational policy, will be
evaluated.
Pharmacists are asked, therefore, to keep ongoing records of ideas, problems, incidents
with individual patients/the prescriber/key worker/co-ordinator, etc. (Ref: Record Form).
The views of the patient will also be formally gathered to ensure the service meets the
needs of all partners.
Further reference, please see Appendix 6
OTHER PHARMACEUTICAL ISSUES
The treatment of the majority of minor ailments is no different for patients receiving
methadone, buprenorphine or buprenorphine/naloxone than it is for any other patient in the
pharmacy. However, there are certain requests which may be common in supervised
consumption patients and there are certain OTC drugs, which may cause problems.
SEE INFORMATION section
Health Promotion
Pharmacists should ensure patients have received a copy of the Methadone Handbook
2002 and the patient leaflet. When appropriate, the pharmacist should refer to the various
aspects covered by the handbook/leaflet
Security of Staff, Premises and Stock
Consideration must be given to provide adequate insurance (e.g. check with the NPA). The
procedure of supervised consumption should not put staff or patients at risk of suspicion.
 Avoid allowing patients access to dispensary stock
 Balance the need of privacy against risk of becoming isolated with a patient
 Ensure compliance with all legal and professional requirements; in particular with regard
to storage of controlled drugs
Local Pharmacists
A pharmacist must be able to reserve the right not to participate in supervised
consumption schemes. It is therefore important to ensure locum pharmacists are
told before they agree to work that they will be expected to supervise the
consumption of methadone, buprenorphine or buprenorphine/naloxone.
The
contractor should ensure sufficient staff training to support a locum pharmacist in
this. Locum pharmacists should also be aware of what to do if contacted by the
prescriber or key worker about new or current patients and have access to, and be
familiar with this operational policy (Please see Appendix 7 advice for Locum
Pharmacists).
18
Dealing with Problems
There are many problems and situations, which the pharmacist is able to deal with
efficiently and professionally. It should not be necessary for the pharmacist to continually
contact the prescriber about the patient’s behaviour or appearance. By developing links
with the prescriber, it is hoped that pharmacists will come to understand what is appropriate
for each individual patient. This area will be covered fully in the training workshops for the
Scheme.
Pharmacists will be expected to use their professional judgement and experience as well as
knowledge of the patient to decide what would be an appropriate reason for contact. The
operational policy makes some suggestions. As there may be occasions, which would not
warrant a specific call, pharmacists should keep an ongoing record (in this manual), which
will assist, at the patient’s regular reviews and for audit of the service.
Confidentiality
Patient confidentiality must be maintained and it is vital that the pharmacist does not
inadvertently discuss the patient with an unauthorised person. This Scheme helps
pharmacists with this as patients have given their consent for pharmacists to discuss their
treatment with their key worker/prescriber. Discussions with the prescriber and the key
worker must be directly relevant to prescribed medication.
Pharmacists are referred to the obligations of part 2 of the Code of Ethics. Pharmacy staff
must also be made aware that they are also bound by the principle and the additional
guidance of the code.
Request for injecting equipment and needle exchange
Patients participating in substitute prescribing programmes may also request injecting
equipment. In such cases, where the pharmacist participates in the local needle exchange
scheme, the required needle exchange packs should be supplied in the usual way. Even in
the most effective methadone programmes about 25% of patients will continue to inject;
many more may inject as a “treat” from time to time. Preventing access to sterile equipment
will not stop them injecting but may well force them to share equipment, which is a serious
public health risk.
The key worker/prescriber will carry out regular urine testing and any additional drug use by
the patient will soon become apparent.
Pharmacists may take the opportunity to talk about the risk of overdose; patients who feel
confident in the pharmacist’s discretion and confidentiality may be more willing to discuss
this and other aspects of their treatment.
Patients must not be made to feel judged by any member of staff as this could impede the
effectiveness of the substitute-prescribing programme and may also lead to risky injecting
behaviour.
A list of pharmacists who participate in the local needle exchange scheme is contained in
the leaflet available with this operational policy. This is a free and confidential service
where patients can obtain sterile needles and syringes and return used injecting equipment
for safe disposal.
19
Training
Pharmacists who take part in this Scheme must be committed to continuing professional
development. The following must be completed:



Induction (workshop or one-to-one)
Attendance at the annual PCT harm reduction workshop
CPPE Distance Learning Course: Substance Use and Misuse (Ideally, to be completed
within six months of the commencement pf provision of the service)
Material, which may be of use:



“The Methadone Briefing” by Andrew Preston, 2002 available from Drugscope.
“Drugs of Abuse” by Simon Wills, published by the Pharmaceutical Press, 1997
Drug Misuse and Community Pharmacy: Jane Sheridan and John Strang, 2003
20
HEALTH AND SAFETY
Helpline for pharmacists under Threat
As with all public situations, there may be times when you feel threatened. If appropriate,
the pharmacist must contact the police. The co-ordinator and the Pharmaceutical Advisers
are also available to offer help and advice.
There have been instances where a pharmacist has felt unable to contact anyone about a
particular problem, in particular related to drug mis-users. In the event of such a situation,
the RPSGB Benevolent Fund “Listening Friends” Scheme can be contacted for free,
confidential support.
The Listening Friends Scheme: Telephone: 020 75 72 24 42
Needle Stick Injury
Any accident with needles or syringes must be reported to the pharmacists. In the event of
a needle stick injury:
 Encourage wound to bleed freely and wash thoroughly with soap and cold water,
splashes of blood in the eye or mouth should be irrigated copiously with water
 Affected person should report immediately to their nearest Accident and Emergency
Department for post exposure prophylaxis – preferably within 60 minutes. (DoH circular
PL/CO (97)1)
 Keep the sharp responsible (in a safe place) and make an entry in the accident book.
Hepatitis B Immunisation



Following guidance, all health care workers should be vaccinated against Hepatitis B
REF: UK Health Departments Guidance for Clinical Health Care Workers: Protection
against infection with blood born viruses. DoH J15/002 12784 HP 75K 1P Mar98 BEL
Care should be taken to avoid exposure to blood or other body fluids
No vaccination is available against HIV or Hepatitis C.
21
TERMINATION OF SHARED CARE CONTRACT
The pharmacist and Doctor have the right to expect the patient to conform with the
behaviour requirements of the contract. Failure by the patient to adhere to the contract may
result in the review of the situation. The prescriber may choose to refuse to continue to
prescribe and the pharmacist may review the continuation of supervision supply.
Cancellation of the contract should be the last choice and it would be expected that all other
avenues have been explored first.
Before any action or decision is taken, please discuss with the PATIENT and at least one of
the following:






Prescriber (Does not apply if the prescriber is reviewing)
Pharmacist (Does not apply if the pharmacist is reviewing)
Key worker
Scheme Co-ordinator
Community Pharmacy Facilitator
Outreach Team.
If all attempts to sort out the problem fail, the contract may be terminated (as a last resort)
by the following means:
Inform patient
Inform prescriber
Inform Scheme Co-ordinator
Inform Pharmacist
Inform Key Worker.
The patient has the right to terminate the contract if they feel that the other parties have not
fulfilled the terms of the contract.
The patient should be encouraged to contact the aforementioned people to discuss their
problems before terminating the contract.
22
Appendix 1
REMUNERATION FOR PHARMACISTS
The last government initiated a number of extensions in the provision of treatment for
serious drug misusers. The present government has continued this policy. Amongst other
things, PCT’s have been asked to:

Facilitate greater involvement of primary care professionals, such as general
practitioners and community pharmacists, in the care of more stable drug mis-users

Support well-managed methadone administration and associated counselling and care
programmes for opiate mis-users, aimed at immediate harm minimisation, with the
ultimate goal of abstinence wherever possible.
Treatment with methadone or similar drugs is believed to be more effective when it is
administered through a formalised ‘partnership’ arrangement. This Scheme aims to bring
together the patient, community pharmacist and the drug misuse service. Participation in
this Scheme will be limited to opiate mi-users who wish to make a commitment to reducing
or eliminating their dependency.
Each contract will require regular attendance by the patient at the pharmacy and the drug
misuse service, as well as regular communication between the three parties, for a period of
up to thirteen weeks, for supervised self-administration of Methadone, buprenorphine or
buprenorphine/naloxone under the observation of a pharmacist on pharmacy premises.
Non-compliance may cause termination of the contract.
The PCT invites contractors to participate in a 12-month contract with the PCT.
Attendance at an annual workshop and completion of the CPPE training package will be
required, upon receipt of the CPPE certificate; an annual retainer fee will be paid. In
recognition of the pharmacist’s contribution, the PCT will pay a flat rate fee of £1.93 per
supervised dispensing. Payments will only be authorised by the Scheme Co-ordinator on
receipt of a copy of the contract and copies of patient record forms.
Local set up and induction training costs will be met by the scheme.
Participating pharmacists must have facilities and staffing levels appropriate for observed
consumption in their premises.
This Scheme has a limited number of supervised dispensing available, in the event of an
over subscription of pharmacy applications, first consideration will go to pharmacies who
are deemed suitable in order to ensure the needs of the service in our area are met.
For these patients who require more than thirteen weeks supervised consumption, the PCT
will arrange further payments for dispensing as required.
23
Appendix 2
Community Pharmacy Supervised
Consumption of Drugs
Annual contract with the PCT
Pharmacy Address
Name of Pharmacy Contractor: ……………………………………………………….
Name of Pharmacist:
………………………………………………………..
Contract to run from: …………………………………
To: 31st March 20 ………….
I agree to provide supervised consumption of:
a) Methadone
b) Subutex
c) Suboxone as part of the Surrey Scheme
I understand that in return this service and complying with the following criteria, the
pharmacy contractor will be paid a retainer fee and supervision fees as agreed with the LPC
and specified in the policy.
 I agree to undertake the required training as specified by the PCT
 I have read and fully understand the operational policy
 I agree to send a copy of my CPPE certificate, the standard operating procedure specific
to my pharmacy and proof of attendance at the workshops/induction
 I agree to provide sufficient information and staff training to enable any managers/locum
pharmacists to provide the service in my absence
 I am aware that supervision payments will only be made when the Scheme Manager at
the Outreach Team receives a signed copy of the shared care contract and the
appropriate record forms
 I agree to provide the service for the term of the contract as stated above.
Signed: ………………………………… (Pharmacist)
Date: ………………….
Signed: ………………………………… (Contractor)
Date: ………………….
Signed: …………………………………. (PCT)
Date: ………………….
Surrey PCT Pharmacists may at any time give notice in writing that they are terminating the
annual contract between the PCT and pharmacy
24
Appendix 3
Supervised Consumption Record Form
For office use only:
Patient Ref:
For office use only:
Payment Ref:
Number of Dispensings:
Patient Initials:
Pharmacy Stamp:
Date of Prescription:
Gender:
Methadone dose:
Date of Birth:
Subutex dose:
Suboxone dose:
Date
Special Instructions
e.g. supervised, daily pick-up, twice
weekly pick-up
Supervised /
Collected
Please circle
Comments e.g.
Sunday dose taken,
changes to original script
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Please make a note below of any INTERVENTIONS, PROBLEMS OR SITUATIONS that you have come across.
This information will be useful when the patient is reviewed and it will help us when we audit the project. Please
include any correspondence with prescriber/key worker, Scheme Manager and any adverse events
Date
Interventions, Problems or Situations
Prescriber/Windmill/
acorn/Respond
Team Contacted
Yes or No
Date patient stopped supervision: ………………………………
Reason (e.g. went into daily pick-up): ……………………………………………………………………….
Pharmacist Name: …………………………….
Signature: ………………….. Date: …………….
On completion, please post this form IMMEDIATELY to:
Community Pharmacy Drug Misuse Manager,
Surrey Harm Reduction Outreach Team,
Parkview Centre for the Community, Blackmore Crescent,
Sheerwater, Woking, Surrey, GU21 5NZ
Tel: 01932 355533 Fax: 01932 350963
25
Appendix 4
List of medication for supervised consumption (September 2007)








Methadone Mixture 1mg/ml (Sugar free)
Methadone Mixture 1mg/ml
Methadone Mixture Concentrate 10mg/ml*
Buprenorphine (Subutex) 400mcg Tabs
Buprenorphine (Subutex) Tabs 2mg
Buprenorphine (Subutex) Tabs 8mg
Buprenorphine 2mg/naloxone 0.5mg Tabs (Suboxone)
Buprenorphine 8mg/naloxone 2mg Tabs (Suboxone)
*CARE. This will only be prescribed on relatively rare occasions and the SOP must
have safety mechanisms to ensure that this is not dispensed unless specifically
asked for.
26
Appendix 5
HARM REDUCTION and DRUG TREATMENT
Harm reduction aims to reduce or limit the harm to communities and individuals caused by
drug and alcohol use.
Key roles for the pharmacist:











Dispensing services – including daily/supervised/instalment dispensing of:
- Methadone
- Buprenorphine – Buprenorphine/naloxone
- Diazepam (when appropriate) or other medication as agreed with the PCT, LPC
and the prescriber
Supply of clean injecting equipment via needle exchange schemes
Monitoring of general health
Harm minimisation advice
- To stop injecting
- To stop sharing injecting equipment
- Safer injecting practices
- Disposal of used paraphernalia
- Advice on safe sexual practices and sexual health
- Supply f condoms
Information re. GP, drug services, needle exchange schemes
Health promotion literature
Monitoring of prescriptions for potential overuse of medicines or for interactions with
non-prescribed drugs or other prescribed drugs (using patient medication records)
Evaluation of legal validity of prescriptions and screening for errors
Identification of inappropriate prescribing
Monitoring the misuse potential of ‘over-the counter’ medicines (OTC)
Advice on smoking cessation.
A flexible approach is essential when working with drug users. It can take time to adjust to
a methadone, buprenorphine or buprenorphine/naloxone prescription, whilst the patient
becomes stable on an appropriate dose and distances him or herself from a range of
cognitive, emotional and behavioural patterns associated with problematic drug use. With
support, supervised consumption can significantly reduce the harm of illicit heroin use, such
as the risk of:




HIV and hepatitis infection
Overdose
Chaotic drug use
Criminal behaviour.
Methadone, buprenorphine and buprenorphine/naloxone prescribing has also been shown
to improve:
 Contact with primary health care services
 Social stability
 Diet and general health.
27
In this sense, prescribing methadone, buprenorphine or buprenorphine/naloxone as a
substitute opiate can clearly be seen as a harm reduction measure. It will minimise the
risks associated with illicit heroin use, namely, health issues, financial concerns, criminal
activity, relationship difficulties, housing problems etc. It is not ‘treatment’ in the traditional
sense where the aim is to ‘cure’ an affliction.
Receiving a regular measured dose of methadone can sometimes be the first step in
enabling the opiate-dependent person to gain stability in their lives. Nevertheless, this
process can take a number of attempts and patients should not be made to feel they have
ever failed a programme as it is always possible to learn from each attempt (fig 1).
Figure 1: ‘Cycle of Change’, taken from Prochaska & DiClemente (1992)
DETERMINDATION ACTION
START: PRECONTEMPLATION
CONTEMPLATION
MAINTENANCE
PERMANENT EXIT
RELAPSE
When patients start a methadone programme, it is desirable to commence them, whenever
possible, on a supervised regimen (bearing in mind working/child care arrangements etc).
However, once the patient is stabilised, they can accept more responsibility through the
introduction of ‘take home’ doses, for example from daily to six times weekly, to two or three
times weekly, to weekly. The pharmacist should recognise the benefit or reimposing
supervision in times of crisis or relapse and discuss this with the prescriber/key worker.
28
Appendix 6
Monitoring, Evaluation and Audit
Questionnaire to Pharmacist, Prescriber and Key Worker
Improvement in Communication





Has this occurred?
Has it worked?
Who has communicated?
What has been communicated?
Has it been relevant?
Financial and Activity Projections




Has payment arrived on time?
Any problems with payment?
Is remuneration appropriate?
Has the project been successful?
It is vital to the success of the scheme that pharmacists are able to demonstrate their
contribution to the ‘shared care’ of the patient. The only way this will be possible is by
ensuring the pharmacist documents any intervention fully, either with prescriber/key worker
or patient. The co-ordinator will help with this process as much as possible.
The pharmacist will be asked to complete a questionnaire asking:
 What they thought of the scheme
 What they thought about the guidelines and information provided
 What they thought about the co-ordinator’s input
 Was anything missed out?
 Is there anything useful to be learned?
 Did the scheme achieve what was expected/hoped for?
29
Appendix 7
ADVICE FOR LOCUM PHARMACISTS
The Pharmacy has a contract with the PCT to provide supervised consumption of
Methadone / Subutex / Suboxone and / or instalment dispensing of benzodiazepines
SUPERVISED CONSUMPTION OF METHADONE / SUBUTEX / SUBOXONE
The full Policy explaining this scheme can be found in the:
………………… Surrey Supervised Consumption Scheme Resource File – Section 1 …….
The Paperwork you will need to complete can be found:
……………….. Surrey Supervised Consumption Scheme Resource File – Section 4 ……...
The following Information may be found:

Prescriptions for this project will be from:
- The Windmill Drug & Alcohol Team (Abraham Cowley Unit)
- Acorn Drug & Alcohol Team
- Respond
- The Access Team
- Specialist Centre’s & Primary Care GP’s

Instalment prescriptions will be written on FP10(HP)(Blue) Instalment prescription
from
Sunday and Bank Holiday doses should be supplied a day in advance if this is the usual
procedure
Each patient will have a contract which will be kept in the policy folder. Take a few
moments to identify how many patients you can expect
Each patient will have a record form located (please complete details):




………………………………………………………………………………………………..
If a patient misses three doses, you must inform the prescriber. However, if this
happens at a weekend, please use your professional judgement and contact the
prescriber on Monday.
INSTALMENT DISPENSING OF BENZODIAZEPINES
Policy and paperwork can be found: …………………………………………………………
USEFUL NUMBERS
The Windmill Team
Acorn Team
Respond
Access Team
Supervised Consumption Manager
01932 872010
01483 450256
01372 379739
01932 875213
01932 355533
30