Supervised Consumption Programme

Vicky Fenwick

Harm Reduction Co-ordinator

West Sussex Primary Care Trust

Produced: April 2007

Review Date: April 2009

ContentsPage Number

Background3

Harm Reduction & Drug Treatment3

Cycle of Change & Drug Treatment4

Confidentiality5

‘Shared Care’ Partners & Information-Sharing5

Payment Procedure6

Locums6

Training6

Medico-legal Aspects6

Supervision Procedures:

Prescriber/Keyworker’ Role7

Examples of Instalment Dispensing Prescription8-9

Pharmacist’ Role 10-11

Appendix A: Example of completed feedback sheet12

Guidance Notes on Feedback13

Appendix B: Example of introductory letter14

References & Additional Reading15

Prescribing Agencies in West Sussex16

Needle Exchange Outlets and Equipment17

Contract and Bank Details 18

Produced by

Vicky Fenwick

Harm Reduction Co-ordinator

West Sussex Primary Care Trust

NE Area Office.

CrawleyHospital, 3rd Floor

West Green Drive

Crawley,

West Sussex, RH11 7DH

T: 01293 600300 X 4245

F: 01293 600362

E:

April 2007Background

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. The role of the community pharmacist has never been so crucial, “contributing importantly to the treatment of patients and the protection of the wider community” (Sheridan & Strang 2003 p139).

These guidelines are for those pharmacists who are willing to supervise the consumption of methadone or the self-administration of buprenorphine whilst working in conjunction with the client, the prescriber and the keyworker from the specialist drug service.

The government recommendations acknowledge that client compliance with the programme is an important issue in the treatment of drug-dependency. Non-compliance with treatment may lead to:

• increased heroin use and associated risks for the client, namely overdose
• continued risk of blood-borne viruses for injecting drug users
• leakage of methadone onto the illicit market.

The issue of leakage of methadone onto the illicit market is one of serious concern. Methadone is dangerous in overdose and it has been suggested that opiate overdoses are of people not in treatment who have bought illicit methadone. Whilst buprenorphine carries far less risk of overdose, even when consumed by the non-tolerant individual, (Lowe, 2003, p46), its potential for misuse – most commonly by injection – has been well documented (Picard 1997). Furthermore 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, whereby pharmacists can support those who need help managing their medication.

These guidelines form the basis of a scheme to pay community pharmacists for their involvement in the treatment of drug-dependency in West Sussex. Pharmacists applying for payment under the scheme are required to comply with these procedures. Please note that nothing in these guidelines changes the legal requirements; pharmacists must, at all times, work within the requirements of the Misuse of Drugs Act (1971).

1Harm Reduction and Drug Treatment

1.1Drug use can be a public health problem, characterised by drug injecting and polydrug use. A harm reduction approach will not only reduce the harm to the individual but will minimise the consequences for the family and public at large.

1.2Pharmacists have an important role to play in two key approaches to harm reduction, namely:

• the provision to those who cannot or are not yet ready to give up intravenous drug use of sterile injecting equipment, which may be used for the injection of street drugs or for the self administration of prescribed medication

• the dispensing of oral substitute drugs for those who are looking to stabilise their drug use and reduce the associated risks.

1.3The approaches are not mutually exclusive and a flexible approach is essential when working with drug users. It can take time to adjust to a prescription, whilst the client becomes stable on an appropriate dose and distances themselves from a range of cognitive, emotional and behavioural patterns associated with problematic drug use. With support, treatment can significantly reduce the harm of illicit heroin use, such as the risk of:

• HIV and hepatitis infection
• overdose
• chaotic drug use
• criminal behaviour.

1.4Prescribing for drug-dependency has also been shown to improve:

• contact with primary health care services
• social stability
• diet and general health.

In this sense, prescribing methadone or buprenorphine as a substitute or partial opiate can clearly be seen as a harm reduction measure. It is not ‘treatment’ in the traditional sense where the aim is to ‘cure’ an affliction.

1.5Sterile injecting equipment may still be required by some clients on a substitute programme. Pharmacies may also provide free needle & syringes services, and more are required in West Sussex. If not involved in a needle/syringe programme, pharmacists should provide information on the location and opening hours of where clients can obtain injecting equipment.

2Cycle-of-Change and Drug Treatment

2.1Receiving a regular measured dose of medication 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 which is why harm reduction remains at the centre of all treatment and a client’s motivation. See fig 1.

Figure 1: ‘Cycle of Change’, taken from Prochaska & DiClimente (1992)

2.2When clients begin a programme it is desirable to commence them as supervised (bearing in mind working/child care arrangements etc). Once the client is stabilised they can accept more responsibility through the introduction of ‘take home’ privileges. The pharmacist has an important role to play in these adjustments through discussion with the client and feedback given to the named keyworker. Likewise the pharmacist should recognise the benefit of reimposing supervision in times of crisis or relapse and discuss with the prescriber keyworker and client.

2.3Through regular contact, pharmacists can build relationships with clients, encourage stable use of methadone, give verbal affirmation, and feedback appropriate information to partners on the programme. This includes both positive gains as well as cause for concern.

3Confidentiality

3.1Confidentiality and discretion are crucial factors in the programme. If there is no private area this must be explained to the client, who can then decide whether to nominate an alternative pharmacy or not. Supervision should not take place in the dispensary.

3.2Should a client within the scheme request other services, particularly needles/syringes, the right of the client to 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 client’s use of mixed substances. Clients should not be made to feel judged by any member of staff as this could impede the effectiveness of the programme.

3.3Should a client 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 client 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).

4‘Shared Care’ Partners and Information-Sharing

4.1‘Shared care’ refers to the participants during the process of treatment of a client and 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” (p10). All people involved in ‘shared care’ are referred to as partners and can consist of:

• the client
• the pharmacist
• the prescriber
• the keyworker
• other relevant professionals.

4.2 Permission should always be obtained from the client prior to any of the partners entering into discussion with another partner. This should be in the form of a signed confidentiality waiver, as included in the attached client contract.

4.3Clients come into daily contact with the pharmacist which allows for the monitoring of client stability. It is difficult to give hard and fast rules about what should be discussed with the prescriber/keyworker. 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 pharmacist and the client. Examples of feedback:

5.1Payment

5.1The fee for this service is £7.50 per seven days, per client. Every seventh day the pharmacist will need to fax a copy of the ‘feedback sheet’ (see p12) to the keyworker and to West Sussex PCT. This allows the pharmacist to keep the original for their records, the keyworker to assess how stable the client is becoming, and payment can be processed.

5.2Fax the feedback sheet to Tricia Walton (Administrator) on 01293 600362.

5.3The fee will be paid monthly direct to the bank via BACS.

6Locums

6.1Locum pharmacists should be made aware of the service and the procedures in advance of them providing locum cover. It is essential that the service runs smoothly and all records are kept up-to-date.

7Training

7.1Pharmacists routinely involved in the provision of this service should complete the distance learning package ‘Drug Use and Misuse’ available from the Centre of Pharmacy Postgraduate Education (tel: 0161 778 4000). In addition pharmacists and staff are encouraged to attend multi-disciplinary training programmes run throughout the county.

8 Medico-legal Aspects

8.1The Royal Pharmaceutical Society of Great Britain provides guidance on all legal aspects and standards including instalment dispensing and professional indemnity, which can be found in the latest edition of ‘Medicines, Ethics and Practice’.

Supervision Procedures

This section of the document specifies the procedures to carry out the service and clarifies the responsibilities of the pharmacist and some ‘shared care’ partners.

9 Prescriber/Keyworker Roles

9.1Choosing a pharmacy: the prescriber will discuss with the client the most suitable/convenient pharmacy. The prescriber must also explain to the client 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 client becomes on their medication. As part of the prescriber/keyworker contract informed written consent to such discussions taking place should be obtained. This is the nature of the ‘shared care’ contract.

9.2Contacting the pharmacy: the chosen pharmacy should be phoned in advance by either the prescriber or the keyworker in order to seek permission by the pharmacist to accept a client on a supervised programme.

9.3Dispensing arrangements: the pharmacist needs to be informed of the dispensing arrangements prior to the client attending the pharmacy. The prescriber/keyworker should verbally inform the pharmacist of the dispensing arrangements with special conditions specified (eg 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 client, the dispensing dose, start and expiry date of the prescription, and the names and contact details of ‘shared care’ partners (see p14). It should be made clear to the client 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.

9.4Prescription details: all prescriptions for instalment dispensing must be written on a blue FP10(MDA) form.

9.5Writing 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 bank holidays if the pharmacy is closed on those days. The prescription should state the total quantity being prescribed, the amount of each instalment and the intervals between dispensing (see overleaf). Strike through any unused part of the prescription.

9.6Delivering the prescription: time allowing, the prescription should be posted to the pharmacist, or handed in by a member of the prescribing team. When this is not possible the prescription can be handed to the client. A new feedback form should be sent out with the prescription, with the relevant patient details and contact name completed.

9.7Missed doses: if the client misses up to 3 consecutive doses the prescriber/keyworker will advise the pharmacist how to proceed (see also 10.12 below). This should preferably be done prior to the client attending the pharmacy so as to minimise confusion and distress to the client and other customers.

9.8Example of instalment dispensing – methadone

Ms Pharmacy

Methadone Mixture 1mg/1ml.

XXXXXXXXXXXXXXXXXXXXX

NHS

PATIENTS – Please read the notes overleaf

9.9Example of instalment dispensing - buprenorphine

Ms Pharmacy

Buprenorphine (Subutex) 8mg and 2mg sublingual tablets

XXXXXXXXXXXXXXXXXXXXX

NHS

PATIENTS – Please read the notes overleaf

10 Pharmacist’ Role

When the client arrives the pharmacist must ensure that the client is correctly identified.

10.1Supervision area: clarify for the client where the supervision will take place. If the client is not satisfied that it is suitably private or discreet they can elect an alternative pharmacy. Wherever possible supervision should be conducted out of public view, in a place that is commonly used for private consultations generally.

10.2Client contract: the pharmacist should then verbally go through the contract with the client, completing the front page with times of opening etc. When agreed both parties should sign two copies – one for the client to keep and one for the pharmacist. The main issues to be covered are:

• what to do when the pharmacy is closed, ie sundays and/or bank holidays;

• missed doses cannot be dispensed at a later date;

• the pharmacist will be feeding back to the prescriber/keyworker the observed effect of treatment on the client;

• that said, the client’s right to confidentiality remains and information given to the prescriber is strictly on a ‘need to know’ basis;

• the client can discuss with the pharmacist any issues arising on a daily basis without fear of the prescriber being informed;

• requests for injecting equipment are not reason enough to inform the prescriber/keyworker;

• the prescriber/keyworker will be contacted and methadone may not be dispensed if the client has missed up to three consecutive days’ doses;

• methadone 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/keyworker may be contacted as a result.

10.3Staff: if appropriate the pharmacist should introduce the client to key members of staff.

10.4The 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. The prescription should stipulate ‘supervised consumption’.

10.5Preparation of medication: daily doses should be made up in advance each day (assuming the pharmacist is in possession of a current prescription). Methadone should be dispensed into an appropriate child resistant container labelled in accordance with the requirements of the Medicines Act. The correct date of dispensing, eg the date of supply to the client, should be shown on the label.

10.6Storage: medication should be stored in the CD cupboard until the client attends.

10.7Dispensing: Clients are highly sensitive to their situation and care should be taken not to disclose to other customers their medication details. Methadone can be dispensed in the bottle or may be poured into a cup. The use of straws should be recommended as a means to promote dental hygiene. Buprenorphine can be popped out of the blister packs either into the client’s hand or into a small disposable pot. Clients may request a drink of water in order to moisten their mouths.

10.8Supervision of methadone or buprenorphine:

1. methadone – ask the client to drink the dose in front of the pharmacist. Clients may request a drink of water afterwards which helps promote dental hygiene. Any containers should be returned to the pharmacist;

1. buprenorphine – ask the client to place the tablets under their tongue, stating that they need to be left to dissolve as swallowing renders them ineffective. Any containers should be returned to the pharmacist.

Ask if the client is well or if they are experiencing any problems etc.

10.11Documentation: after each supervision the pharmacist should then make the appropriate entries in the CD Register, on the prescription and the feedback form.

10.12Missed doses: if a client fails to collect three consecutive doses no further medication should be dispensed without the agreement of the prescriber/keyworker. If three consecutive doses have been missed the pharmacist should try to contact the keyworker prior to the client next attending the pharmacy. This means that when the client does attend they can be advised immediately about their prescription and will not have to wait around the pharmacy unnecessarily. Make a note of the prescriber/keyworker decision on the feedback sheet, including date and time of conversation. Individual missed doses (one or two days) also need to be documented on the feedback form but do not necessarily need to be alerted to the prescriber on that very day. Use discretion; if you are concerned about the client the prescriber will be pleased to hear from you. However, it may upset the client’s overall progress on the programme if they think you have been ‘telling tales’ behind their back. Where appropriate, raise the issue of missed doses with the client when they next attend; the client may be at risk of overdose if their tolerance has dropped, or if they have been using additional substances.