Borders Prescribing Protocol



NHS Borders, Borders Community Addiction Team

Medical Treatment Guidelines for Drug Misusers in the Borders

Prescribing Protocol 2011

ADTC Approval – January 2011

Dr Michael Kehoe Dr Jenny Forbes

Lead Clinician GP Specialist in Addictions

Lynda Mays Adrian Mackenzie

Service Manager Lead Prescribing Support Pharmacist

Shirley Watson

Clinical Pharmacist, Mental Health

Contents Page 2

• 1) Philosophy of Care Page 3

• 2) Background Page 3

• 3) Aims of a Prescription Page 4

▪ 3.1 Detoxification and Abstinence Page 4

▪ 3.2 Substitution Prescribing Page 4

• 4) Prescribing in the Scottish Borders Page 5

▪ 4.1 Opiate Dependence Page 5

• 4.1.1 Prescribing Process Page 5

• 4.1.2 Best Practice Initiating Page 9

• 4.1.3 Ongoing Prescribing Page 10

• 4.1.4 Stopping Prescribing Page 13

• 4.1.5 Discontinuing Supervision Page 13

• 4.1.6 Naltrexone Page 16

• 4.1.7 Lofexidine Detoxification Page 18

▪ 4.2 Benzodiazepine Dependence Page 21

• 4.2.1 Best Practice (opiate dep.) Page 22

• 4.2.2 Best practice (non-opiate) Page 23

• 5) Clinical Governance and Quality Standards Page 24

• 6) References Page 25

Medical Treatment Guidelines for Drug Misusers in the Borders

1) Philosophy of Care

The NHS Borders, Borders Community Addiction Team (BCAT) undertakes all prescribing activity for drug misusers in the Scottish Borders. BCAT recognises that substance misuse is a multi-faceted and complex issue that affects all aspects of an individual’s life and their families. We believe in a person-centred, recovery focussed, needs-led approach to care and treatment that does not judge or stigmatise; it respects values and choice; dignity and equality. By working in partnership with service users, carers and multidisciplinary teams/agencies, we can: promote communication, encourage positive life style changes, promote safety and focus on the development of an individual’s responsibility in their care and treatment.

BCAT utilises a variety of approaches in developing individualised care, all of which include emphasis on the principles of a bio-psycho-social approach, brief interventions and motivational interviewing. We acknowledge substance misuse can be a relapsing condition, and sometimes finding the courage to try again is a key part of an individual’s journey to recovery.

Treatment of drug and alcohol misusers incorporates many approaches, which may seem to be in conflict – ranging from ‘harm reduction’ approaches, aiming to reduce the biological, psychological or social ‘harm’ a substance misuser is causing themselves and their community, through to total abstinence. People attending BCAT for drug problems will vary greatly in their presentation and it must be recognised that all people do not require (or may want) a replacement prescription to overcome their drug problem. Any philosophy of care must recognise this.

2) Background

This guideline was written by members of the Borders Community Addiction Team and in consultation with pharmacy colleagues with the aim of describing the appropriate, best practice use of prescribed treatments for drug misusers in the Scottish Borders. This guideline is adapted from the Lothian, Fife and Tayside guidelines on prescribed treatments for drug dependence. They are offered to aid best practice in this area of care.

It incorporates:

Treatments for Opiate dependence

Treatments for Benzodiazepine dependence

This guideline takes into account the updated UK guidelines on clinical management (2007) and the national drug strategy, “Road to Recovery”. It also takes account of NICE guidelines and other best evidence base practice.

The guideline will be reviewed annually to take account of any future updates and developments.

3) Aims of a Prescription

3.1 Detoxification and Abstinence: Drug and alcohol dependence leads to a variety of withdrawal syndromes, comprising physical and psychological symptoms according to the class of drug involved. Withdrawal can be distressing for the individual and may be hazardous. Detoxification is the process by which the agent of dependence is eliminated from the body. Lofexidine (to alleviate withdrawal symptoms) and Naltrexone (to block opiate receptors) are used in specific situations (see later in document) and have clear indications and an extensive evidence base to support their use (NICE Guidelines). These options require keyworking and close co-operation between professionals and can take place in in-patient or community settings.

3.2 Substitution Prescribing: It is recognised that significant health gains may be achieved by the cessation and reduction of illicit opiate use. Evidence clearly shows that replacement prescribing of methadone or buprenorphine for those dependent on opiate drugs can be an important element of a treatment package (NICE guidelines, 2007). For some service users, methadone substitution therapy may be an appropriate treatment. It is essential to balance the benefits with potential risks (dangers of intoxication, long-term treatment and replacement of one drug for another). A range of methadone substitution regimes may be provided as clinically indicated, and can be low threshold, high threshold, short or long term. Much preparatory work often precedes a replacement prescription to ensure prescribing occurs safely. It is only one step of a service user’s journey to recovery and ongoing work must be undertaken and continued commitment to change must be demonstrated to remain on a prescription.

There is no significant evidence base to support replacement prescribing for any drug group other than opiates (UK Guidelines 2007). A fixed detoxification regimen involving associated psychological support has the most support nationally for treating benzodiazepine misuse (COCHRANE review, 2006).

Alongside any prescribed options psychosocial interventions and recovery focussed work is undertaken to assist patients to attain optimum health and social functioning and reduce damage related to drug use. Drug users present to services with a variety of health and social needs associated with their drug use including; risk of hepatitis B & C, and HIV infection and some (other) sexually transmitted infections.

The service is proactive in health promotion and testing for HIV and Hepatitis is routinely undertaken. In addition vaccination for hepatitis A and B is always offered. Through education, information, counselling and advice, in a safe non-judgemental environment, service users are enabled to explore anxieties and concerns relating to health issues arising from their substance use. Through close partnership working with colleagues in the Scottish Borders Council education, housing and employability are also routinely addressed.

4) Prescribing in the Scottish Borders

4.1 Opiate Dependence

All prescriptions from BCAT must adhere to these guidelines.

The only licensed medications approved for treatment of opiate dependence in the Borders are:

• Methadone 1mg/ 1 ml. Methadone mixture 1mg/ 1 ml is the methadone formulation exclusively used to treat substance misuse in the Borders. There are no circumstances in which the use of alternative formulations (tablets or injectables) are indicated to treat opiate dependence.

• Buprenorphine (Subutex) 0.4mg, 2mg and 8mg sublingual tablets

• Buprenorphine/ Naloxone (Suboxone) 2mg/ 0.5mg and 8mg/ 2mg sublingual tablets. The Scottish Medicines Consortium has advised Suboxone should be restricted for use in patients in whom methadone is not suitable. As a result BCAT will not ordinarily commence suboxone prescriptions and those on existing prescriptions arriving in the Borders will usually be transferred to supervised Buprenorphine.

• Naltrexone 50mg tablets

• Lofexidine 0.2mg tablets

• Naloxone 1mg/1 ml as per NHS Borders PGD will be used as part of the National Take Home Naloxone initiative – due to start in Autumn 2011.

Dihydrocodeine (DF118) and all other opiate- based analgesics are not licensed for the substitute treatment of substance misuse and should never be prescribed for this purpose. The only time BCAT would prescribe Dihydrocodeine would be as part of an in-patient detoxification if agreed with the service user and keyworker/ medic.

4.1.1 Prescribing Process: Procedure for Methadone/ Buprenorphine Dose Assessment – Tolerance Testing

• Function: To ensure safe and effective prescribing of methadone/ buprenorphine and to minimise the negative effects of withdrawal.

• All individuals commencing onto a substitute prescription for opiate dependence will undergo tolerance testing adhering to this locally agreed protocol.

• Dose assessment is the titration of a dose of methadone/ buprenorphine against the subjective symptoms and objective signs of opiate withdrawal. The aim of tolerance testing is to determine a dosage of methadone that will comfortably relieve and prevent withdrawal without producing sedation.

• Titration is the process of adjusting a prescribed dose of methadone/ buprenorphine, which is already established, but the patient is continuing to use other opiates because of reported opiate withdrawal and therefore requires to be stabilised on a higher dose. While the two procedures are similar in the titration process the initial dose on day one would be the usual prescribed daily dose.

• Location: NHS Borders Hume Ward where tolerance testing is carried out.

• Responsibility: Medical and clinical staff in the Borders Community Addiction Team. 1 medical prescriber, 1 trained staff member of nursing staff to provide continuity and any 1 other member of the team. Either the medical prescriber or the trained staff to have met each person being tolerance tested prior to the procedure.

• During the 3 days of the tolerance test there should be continuity of staff members for accurate, objective observation recording and relationship building with patients.

• Methadone/ buprenorphine dose assessment is potentially beneficial where:

o The patient is methadone/ buprenorphine naive

o The patient’s reports of drug use are above that for which an ‘equivalent dose of methadone’ can be recommended without supervised consumption and observation of tolerance.

o The stability of the patient’s drug use cannot be confirmed and a methadone/ buprenorphine detoxification programme is the preferred treatment method.

o Those patients who report nausea or vomiting after methadone or who have physical health problems which make close initial observation desirable.

• Criteria before tolerance testing and prescribing include:

o The client must be opiate dependent (ICD-10 classification), as confirmed by all objective tests being positive for opiates (minimum 2 and > 7 days apart), service user self reports and drug diaries (minimum 14 days).

o Completed comprehensive assessment including mental health assessment if required, physical health assessment (including B.P., pulse, weight, + urine dipstick, ECG) drug-using history and background/ social history. For those starting buprenorphine baseline LFTs performed and a caution card as issued by the drug manufacturer will be issued.

o Team discussion to establish and document if methadone prescribing is appropriate, full engagement with BCAT and GP registered and consent form completed. Behaviour and attendance at tolerance testing will be discussed and a prescribing contract signed.

o Prescribed treatment integrated into that person’s recovery care plan with clear aims and no unnecessary delays.

o The results of a urine or mouth swab specimen taken in the week before tolerance testing must be available.

o Methadone handbook and/ or buprenorphine literature worked through with their keyworker and questions addressed.

o The patient will have provided a drug diary of not less than one week old.

o If they are on a prescription and the reason for tolerance testing is to increase their dose, the maximum dose for prescribing will not exceed 100mgs of methadone per day unless the multi-disciplinary team have discussed and agreed that the patient will require over this amount.

o The Addiction doctor and the trained nurse will give the initial dose. This will follow their discussion after completing the withdrawal symptom checklist. The patient will have signed a contract that explains the procedure and has also consented to titration. A copy of this will be placed in the patient’s notes.

o The patient is expected to attend at 9:30am for a morning clinic or at 12noon for an afternoon clinic. The patient will remain in the clinic for at least 3 hours. During that time the following actions will be taken:

• Methadone/ buprenorphine collection: During the procedure all methadone/ buprenorphine is to be stored in a controlled drug cupboard in accordance with NHS Borders trust policy and requirements in legislation (Medicines Act, 1968, Misuse of Drugs Act, 1971).

• Methadone/ buprenorphine will be administered to patients strictly in line with the Trust’s policies for the administration of controlled drugs.

• Ensure sufficient supply on site for the remainder of the procedure. Responsibility for ordering should be undertaken by staff on the preceding day.

• Ensure pre-TT checklist completed.

• Day 1: Ensure a current drug diary and recent drug screen is available.

• Check that basic resuscitation equipment is available, including naloxone.

• Establish that no methadone has been taken in the last 24hours, no buprenorphine, heroin or other drugs (especially amphetamines, alcohol, benzodiazepines) have been taken in the last 16 hours.

• If there is a suspicion of recent alcohol consumption then a breathalyser reading should be obtained. A level exceeding 20mg/ 100ml will lead to discontinuation of the procedure.

• Complete the Opiate withdrawal subjective and objective scales. The absence of withdrawal symptoms will lead to discontinuation of the procedure and no substitute prescribing will occur.

• The initial dose of methadone/ buprenorphine is administered and recorded. The Addiction doctor and the trained nurse will give the initial dose. This will follow their discussion after completing the withdrawal symptom checklist. For methadone, this dose will not usually exceed 40mg and a methadone naïve service user will often receive less than 30mg. For buprenorphine, this dose will be in the range 2- 6mg.

• Following the initial dose the service user remains on-site:

o Patient is observed closely for 1 hour.

o Signs of intoxication are monitored.

o After 2 hours the withdrawal checklist is completed.

o If there are signs of opiate withdrawal, however mild, a further dose of methadone/ buprenorphine should be administered. This will be in the range 5 – 10 mg (methadone) 2mg (buprenorphine). For someone starting methadone the maximum daily dose on Day 1 will not exceed 40ml and for buprenorphine the maximum will be 8mg, given in the above regime.

o The service user is again recorded for signs of intoxication and BP/ Pulse recorded after one hour (if there is still evidence of withdrawals despite a maximum on Day 1 of 40ml Methadone, they must be reassured and encouraged not to use illicit drugs before being seen the following day.)

o Service users should be reminded that they must not use any illicit/ non-prescribed drugs (including alcohol) as this may result in the procedure being discontinued on Day 2 and places them at risk of accidental drug overdose.

o It is essential that all patients undergoing methadone tolerance testing be provided with a further copy of the ‘methadone handbook’ and the contents discussed on Day 1 of the procedure. This can be done with the patients as a group. Buprenorphine can be discussed in the same way. Because of the time available there is the opportunity to reinforce harm reduction initiatives, undertake motivational work and discuss non-opiate pain relief options.

• Day 2: Service users should attend promptly and the withdrawal checklist is completed. If the service user is intoxicated or has evidence of recent illicit drug use the procedure will be abandoned.

o If only minimal signs of withdrawal are apparent then the total dose from Day 1 should be repeated. If obvious withdrawal features are present then the total dose from Day 1 together with an increment of 5 – 10 mg (methadone) or 2- 4mg (buprenorphine) should be administered.

o In all cases patients are monitored for 1 hour and the withdrawal checklist repeated. Further dose adjustments of 5 – 10 mg (methadone) or 2- 4 mg (buprenorphine) can then be repeated with a further withdrawal symptom check after another 1 hour.

o On-site drug screen should be taken to test for recent stimulant and opiate use. Urine tests should be sent to the laboratory in Edinburgh for 6- MAM confirmation of very recent heroin use.

o A 1-day prescription for the total dose of methadone/ buprenorphine received on Day 2 will be issued for dispensing and supervised consumption at an already agreed community pharmacy, dated; the following day (Day 3).

o Teaching of overdose prevention is undertaken during Day 2, making use of an educational DVD. Health promotion work is also commenced and should be tailored to specific requests from the group. Topics that can be covered include:

• Diet and healthy eating advice, including BMI recording

• Dental care and list of dentists, include pain relief discussion

• Safe sex and contraception discussion, sexual health nurse contact

• Exercise and community resources, support worker information

• Sleep hygiene worksheets

• Anxiety management workshop

• BBV testing and vaccination discussion

• Day 4: Patients should attend promptly and the withdrawal checklist is completed. In practice many patients will have reached an optimal dosage of methadone/ buprenorphine by the end of Day 2.

o If no signs of withdrawal are apparent then the total dose from Day 2 should be repeated. If obvious withdrawal features are present then the total dose from Day 2 together with an increment of 5 – 10 mg (methadone) or 2- 4 mg (buprenorphine) should be administered.

o In all cases patients are monitored for 1 hour and the withdrawal checklist repeated.

o Further health promotion work is undertaken and should be tailored to specific requests from the group, and complement that received on Day 2. Topics that can be covered include:

▪ Diet and healthy eating advice, including BMI recording

▪ Dental care and list of dentists, include pain relief discussion

▪ Safe sex and contraception discussion, sexual health nurse contact

▪ Exercise and community resources, support worker information

▪ Sleep hygiene worksheets

▪ Anxiety management workshop

▪ BBV testing and vaccination discussion, Hep C nurse involvement

• Observation: The importance of close supervision and observation of patients undergoing tolerance testing cannot be overstated given the risk of overdose. Any unexplained absences or time unsupervised should be a cause for concern. Signs of unexplained and acute intoxication should prompt an urgent clinical evaluation.

• Special cases e.g. pregnancy, young people, extremely chaotic drug use, physical or mental health co-morbidities should be discussed and in-patient titration considered if prescribing options being explored.

4.1.2 Best Practice for Initiating Substitute Prescribing (UK Guidelines 2007):

• For service users not open to BCAT- do not initiate a new substitute prescription on the first assessment. Urine toxicology must be performed to confirm the patient’s history and opiate use prior to prescribing.

• For those already on a prescription moving to a practice and seeking ongoing prescribing- these patients can be referred urgently for BCAT assessment and prescribing. In the event that primary care wishes to continue the prescription: only prescribe an opiate substitute if continuing that person’s treatment and have agreed with previous service provider to continue it, ensuring continuity and no double prescribing by discussing with the previous prescriber and community pharmacy. These prescriptions must be for buprenorphine tablets or methadone 1mg/1ml mixture and should return to daily supervised consumption from whatever previous dispensing regime they were on until stability on a prescription is confirmed with attendance at follow-up and urine toxicology. BCAT is available for assessment or advice on any aspect of this for transferring service users.

• For those in BCAT: Never prescribe at the first assessment.

• Always assess the person fully before considering a prescription.

• Always ensure a drug screen is seen before proceeding.

• Always carry out a tolerance test on the first dose.

• Always start with a supervised dispensed prescription for 3 months

• In the Borders BCAT will initiate the majority of new methadone/ buprenorphine prescriptions.

• If other doctors feel compelled to prescribe they are advised to contact BCAT at the earliest convenient time and should always endeavour to get advice before commencing.

• Methadone/ buprenorphine will only be commenced following adequate assessment.

• Methadone/ buprenorphine prescribing must only occur in dependent individuals.

• The first dose of methadone/ buprenorphine should reflect the person’s daily use and should not exceed 40mg or 8mg respectively.

• The first dose of methadone/ buprenorphine should be administered in a setting in which observation is available with the person observed for at least 3 hours with regular assessment for over sedation.

• All subsequent doses will be supervised at the pharmacist for minimum 3 months.

• The following doses will depend on each weekly assessment and increases should either 1) reflect the daily dose identified during a comprehensive assessment process or 2) increase at maximum 10 mg (methadone) or 2- 4mg (buprenorphine) increments every 3- 5 days.

• UK Guidelines suggest an adequate treatment dosage may fall in the range 60- 120 ml methadone. The evidence base and BCAT support optimal dose prescribing to reflect the individual’s clinical needs. Doses of more than 100 ml methadone must be discussed with the Lead Clinician in Addictions.

4.1.3 Ongoing Substitute Prescribing Guidelines:

1. All people prescribed for will be the subject of regular review by the doctor. This should occur no less than 3 monthly. These meetings must be recorded in legible handwriting in the contemporaneous notes. A prescribing contract will be signed by the service user, community pharmacist and prescriber clearly outlining individual expectations and acceptable standards for all concerned (see Appendix 1).

2. All people prescribed for must be seen regularly by their keyworker depending on need and ongoing therapeutic work. This will occur no less than monthly (and at early stages will occur more frequently- first three months- weekly; at least fortnightly until stabilised). Monitoring activity will include: testing (urine or oral fluid), physical examination, completion of any outcome measures. These will be recorded in legible handwriting in the contemporaneous notes.

3. All new prescriptions will be supervised daily dispensed for 3 months minimum. The keyworker should liaise with the pharmacist prior to three monthly reviews.

4. Supervision may be lifted if the person is 100% compliant with treatment (attendance, use, behaviour), reflecting their recovery journey. In some cases ongoing supervision is required for longer even if compliance is achieved. These include: living with an active user, no safe storage of methadone available with children in the house, recent history of dealing, limited ability to take full responsibility for their prescription (e.g. 100 ml daily or less but with a cardiac history as above must have an annual ECG that gets reported or more regular if indicated. Any service user prescribed buprenorphine will have repeat LFTs at 6 weeks and worsening function will trigger an immediate prescribing review.

11. In the event of completion of a successful treatment programme a prescription would stop through negotiated agreement following a reduction schedule or prior to a detoxification. Prescriptions may require to be stopped if they are seen to be ineffective or dangerous to the person or others. Ineffective prescriptions will be reviewed with the person and alternative strategies discussed and initiated. It is not helpful to stop prescriptions as some sort of punishment for misdemeanours. Prescriptions will only stop if clinically indicated and the reasons will be explained to the person whenever possible. In special cases (such as pregnancy) every effort must be made to retain the prescription. However, at times cessation will be necessary until a review of the case can occur and this procedure should be undertaken as safely as possible. No treatment should be stopped arbitrarily – cessation of treatment can be associated with increased risk of chaotic drug use and death. Indicators for an immediate review of methadone prescription include:

• Continuous ongoing illicit use (self report, testing or injection sites): 2 consecutive reports or tests should trigger review by medic and keyworker.

• Repeated failure to attend appointments (DNA): 2 consecutive DNAs should trigger review by medic and keyworker.

• Threats or acts of violence or intimidation towards staff/ GP/ pharmacists: Any such episodes make a safe and meaningful therapeutic relationship impossible unless dealt with and make prescribing dangerous. Any episode should trigger a review by doctor and keyworker.

• Dangerous use of script – to self – e.g. alcohol, IV use: In such cases the user should be challenged with the issues and counselled regarding safety of their prescription. Any issues they may have should be addressed. Clear plans and expectations should be laid out and review dates set. Failure to demonstrate behaviour change should lead the clinical team to set clear boundaries for the user. Continued dangerous use in the face of this action should trigger a prescription stop and reassessment of the person’s needs.

• Dangerous use of script – to others – e.g. children or evidence of dealing/ fraud relating to the prescription: In a case of children being exposed to these drugs or a confirmed episode of prescription fraud/ seeking of double script the prescription should cease immediately pending an immediate review of the case. Staff must also consider seriously the need to instigate child protection procedures.

• Failure to collect prescription (2 days or repeated event): prescription should be highlighted immediately pending an immediate review of the case by keyworker and prescriber.

• Failure to supply test sample on 2 consecutive requests: prescription should be highlighted immediately pending an immediate review of the case by keyworker and prescriber.

• Information received from a third party should trigger review and discussion e.g. police information regarding law-breaking activity.

Cessation of prescription will lead to discussion with the person and an assessment of risk by doctor and keyworker with a view to creating a recovery care plan, which delivers the most appropriate treatment option to meet need. Discussion should cover the following issues if relevant:

• Ineffectiveness of prescription

• Failure to attend

• Poor compliance/ unsafe use of medication

• Inappropriate behaviour, violence etc.

When a prescription is stopped the person will be notified verbally if attending and will always be notified in writing. If stopped the pharmacist and GP will be informed by phone and circumstances explained and advice regarding ongoing care given. This will be followed up in writing to the GP.

4.1.4 Stopping prescribed methadone/ buprenorphine or benzodiazepines

• Stopping prescriptions should only be used as a last resort when safety is a concern, treatment is not progressing or therapeutic engagement is lost

• Those in receipt of prescriptions should be given the option to avoid loss of the prescription if at all possible and the decision should never be taken without the person being aware that it is an option being considered

• If a prescription is to be stopped the person should be seen as soon as possible and alternative treatment options discussed and agreed. Loss of a prescription does not mean loss of a service

• Doctors should not simply supplement prescriptions with other opiates or benzodiazepines

Use of medications such as loperamide for symptom relief is reasonable but must be time limited

• Any case where methadone/ buprenorphine is stopped should be reviewed by BCAT as a clinical governance exercise

• Diazepam may require a reducing regimen to avoid seizures

• Any such prescription change should be clearly recorded and followed by communication with all relevant professionals involved in the case

4.1.5 Discontinuing Supervised Consumption of Substitute Guidelines

• Supervised consumption of methadone/ buprenorphine has become a key component of any substitute prescribing programme. It has an important role in supporting patient compliance and safety, and in preventing diversion of controlled drugs onto the street. It is essential for patients being started on substitutes and for patients whose dose is being reviewed or increased.

• Good information sharing between prescribers, pharmacists and other relevant health staff is essential: the role of pharmacists has been reviewed in detail in “Guidelines for Dispensing and Supervised Self Administration of Methadone by Community Pharmacists”. These guidelines include detailed advice on responding to situations where a patient fails to attend for supervised dispensing and where there are child protection concerns.

• Supervised consumption corroborates that the prescribed dose has been taken, allows regular monitoring of the individual during titration, and helps check that the dose is correct for the patient (i.e. neither too high or low). It helps to reduce the likelihood that prescriptions are being illegally shared, swapped or sold. Supervision also facilitates the development of a valuable supportive relationship between the community pharmacist and the patient. Daily contact allows the pharmacist to provide health promotion advice and to monitor patient compliance (e.g. missed doses), suspected misuse of illegal drugs and alcohol, and the patient’s general wellbeing.

• The recommendations for supervised consumption during initiation and titration will usually involve a period of around three months’ supervision, in keeping with the 2007 D. of H. Guidelines on Clinical Management. In many cases the service user is allowed to take more responsibility for their substitute prescription, reflecting their recovery. A stable service user is likely to progress to non-supervised methadone and a gradual reduction in dispensing frequency, according to their circumstances and substitute dose. Daily dispensing and/ or supervision, however, can be re-instated during crises or relapse and at any time if the prescriber has concerns to warrant it.

• The decision to discontinue substitute supervision is an important one, and requires consideration of the following key points. Ultimately, the safe and appropriate use of the prescribed substitute is the prime concern.

o Is the patient on a stable dose of substitute? In general, a patient whose substitute prescription is being initiated should remain on supervised until at least two weeks after they are on a stable dose; this will always involve a total period of at least three months. In addition, any patient whose dose is titrated up should have supervised consumption until at least two weeks after they are stable on the higher dose.

o Has the patient discontinued regular illicit opiate use? Evidence of stability and achievement of mutually agreed goals, including compliance with treatment and improved toxicology results, would support discontinuation of supervision. In reality many service users, although stable on their substitute, will continue to use occasional opiates and their overall progress may be relevant. Positive contingency management techniques may be used, with greater take-home privileges in exchange for negative toxicology and other positive changes.

o Is it likely that the patient will use their substitute prescription appropriately? Daily dispensing, even without supervision, may help, but will not fully control the way an individual takes their substitute medication. The prescriber should assess if the individual is at risk of hoarding and/ or binging, either due to intermittent use of illicit opiates or a desire for intoxication or self-harm. Some individuals, such as those with learning difficulties, may be less able to manage safely without the support of daily supervision.

o Are there factors, which increase the individual’s risk of overdose? Such factors include chaotic polydrug use, especially of benzodiazepines and alcohol, previous overdose or self-harm, physical health concerns, social isolation, recent release from prison and recent relapse after detoxification.

o Is the service user willing and able to ensure medication is safely stored? It is important to stress to any user that they have a responsibility to ensure that their medication cannot be taken, deliberately or accidentally, by anybody else. It is of particular importance that they understand the high risk if it is taken by an opiate naïve individual or by a child. Patient leaflets on methadone and other appropriate information should be given, and storage arrangements discussed in detail. It is also essential to document in the notes that this has been done, and the storage location noted prior to reduction of supervision arrangements.

o Are there children in the household? As stated above, it is essential to discuss the risks if a child takes even a small quantity of methadone. It is important to ensure that the patient can store medication in a locked box. Where a home visit has been carried out and storage arrangements confirmed this should be recorded in the notes.

o Is there ongoing involvement from Children and Families Social Work? The prescriber should consider discussion with other involved professionals who may have additional relevant information. It may also be useful for them to know the service user’s level of supervision is being decreased and that there will be a prescription at home, particularly if they are also considering altering access arrangements, decreasing the level of monitoring etc., in cases where there have been ongoing child protection concerns.

o Are there particular benefits to the service user in being able to corroborate compliance? In some circumstances, it may be beneficial to the patient to be able to corroborate their compliance with treatment by remaining on supervised consumption. This may include Child Protection or when lower-level child concern reviews are underway or when court reports are pending. Some patients may prefer the security of this arrangement and consider themselves vulnerable or unsafe if not supervised. Such request should be respected.

o Is the service user vulnerable to pressure or temptation to sell or give their methadone to others? The prescriber should be aware of concerns raised by other professionals e.g. a pharmacist may report that there are often individuals waiting for the patient when they collect their prescription. Some patients may be vulnerable to pressure to share their medication with a partner – it may be supportive to allow them to ‘blame’ the prescriber for continued supervision, which stops them from doing this.

o Is continued daily supervision impeding their progress? This may apply to patients ready to enter employment, education or other activities, which may be impeded by the need to attend the pharmacy daily. If possible, obtain corroboration of the information. If the prescriber thinks supervision is still required, it may be helpful to make arrangements with an alternative pharmacist. Alternatively, supervision less than six times a week may be indicated e.g. allowing take-home doses for days when they attend Community Service or training courses.

o Is the service user experiencing particular disadvantages from supervision? These may include:

• Contact with other drug users may be increased

• More difficult to maintain confidentiality especially in small communities

• Daily travel and associated costs may be difficult for those living a distance from the pharmacy

• Lessens the development of personal responsibility which can be associated with take-home privileges

• May deter some individuals from remaining in treatment

4.1.6 Naltrexone

Function: To ensure safe and effective prescribing of Naltrexone and help to prevent relapse.

Background: Naltrexone is an opiate antagonist which acts by blocking the action of opiates and causes withdrawal symptoms in opiate dependent individuals. NICE guidelines describe the evidence base for Naltrexone preventing relapse in abstinent individuals and the UK Guidelines (2007) support naltrexone prescribing in treatment services.

Naltrexone is a treatment option for detoxified formerly opioid dependent service users who have stayed abstinent for a minimum of 7 days.

Location: In service users homes, GP practices and NHS Borders premises.

Responsibility: Borders Community Addiction Team members will carry out naltrexone prescribing using the following protocol. This protocol has been used extensively by BCAT and is adapted from similar protocols for Fife and Tayside NHS Addiction Services.

Exclusions:

• Hypersensitivity to naltrexone

• Deranged liver function tests or history of liver disease

• Breast feeding mothers and caution in pregnancy

• Currently prescribed or taking opioids (e.g. analgesics)

Criteria for prescribing naltrexone:

• Completed a BCAT assessment that includes; mental health assessment, physical health assessment, drug use history and life/ social history.

• Baseline LFTs performed.

• Confirmed as opiate dependent and abstinent.

• The results of a urine specimen taken before prescribing naltrexone must be available.

• The service user will have provided a drugs diary of not less than one week old.

• Team discussion to establish if naltrexone prescribing is appropriate and the nature of the continuing recovery treatment and relapse prevention programme from BCAT.

Procedure prior to Day 1:

• The decision to prescribe will have been made by the trained nurse and BCAT prescriber following discussion. The service user will have signed a contract which explains the medication. A copy of this will be placed in their notes.

• Naltrexone will be monitored by the keyworker and prescribed by BCAT. The regime is agreed and the prescription is issued for 28 days to be dispensed on a daily supervised basis by the pharmacist.

• The pharmacy must have agreed in advance to dispense and supervise the Naltrexone in the dose 50 mg/ day.

• It is essential that all service users undergoing naltrexone prescribing are provided with a copy of the Naltrexone information booklet and the contents discussed prior to and on Day 1 of the procedure. Because of the time available it is also an opportunity to reinforce harm reduction initiatives and undertake motivational work. This will be done by the keyworker. Opioid tolerance reduces rapidly on prescribed naltrexone and hence the risk of overdose following relapse is significant and must be comprehensively discussed with the service user.

Procedure Day 1:

• Ensure a recent drug screen result is available demonstrating the service user is opiate negative.

• Have the service user complete the subjective opiate withdrawal scale (O.W.S.) and the dedicated trained nurse complete the objective O.W.S. (BP, pulse and temperature).

• The initial dose of Naltrexone will be 25 mg. The service user will pick-up the naltrexone and the first dose will be taken in front of the pharmacist.

• Following the initial dose the service user is observed closely by the keyworker for 30 minutes. They will be checked for any signs of distress or light headedness and have their BP checked.

Procedure Day 2:

• If the 25 mg dose is tolerated a prescription for 50 mg naltrexone/ day is issued for daily supervised consumption at the agreed pharmacy.

Follow up:

• Weekly with the keyworker and urine screened and results recorded. Overdose risk following relapse to be discussed at each review.

• Medical review after 4 weeks

• Repeat LFTs after 6 weeks. In the event of worsened LFTs the case must be urgently reviewed by the prescribing medic.

• If successful (i.e. continued opiate abstinence) the service user can be switched to three times/ week dosing (i.e. 100 mg Monday, 100 mg Wednesday and 150 mg Friday).

• Three monthly recovery care plan review.

• Prescribing can continue for 6 months initially and longer if thought beneficial.

4.1.7 Lofexidine: Procedure for Community Detoxification with Prescribed Lofexidine

Function: To ensure safe and effective prescribing of Lofexidine and minimise the negative effects of withdrawal from opiates.

Background: Lofexidine is an alpha-adrenergic agonist drug that suppresses withdrawal over activity of noradrenergic neurons. Thus it effectively suppresses autonomic signs of withdrawal, but is less effective at suppressing symptoms of subjective discomfort. It is a structural analogue of clonidine, but less sedating and less hypotensive. Lofexidine is formulated as 200 microgram tablets. There is a strong evidence base to support its use in aiding detoxification (NICE guidelines).

Lofexidine is a treatment option for patients new to treatment who are seeking opioid-substitution/ stabilisation treatment e.g. heroin dependent service users, opiate-dependent service users using combinations of heroin and illicit methadone (equivalent to less than 30ml methadone) and methadone- dependent service users reduced/ stabilised at doses 30ml or less. It is a treatment option for community detoxification from heroin/ methadone as an alternative to buprenorphine or continuing methadone reduction. It is also an option as a priority for younger heroin users, heroin smokers and those not wanting or previously failed on methadone treatment. However long-term and regular intravenous users should also be included for consideration. A stable social environment is highly desirable with a nominated ‘significant other’ present.

Location: In service users homes, GP practices and NHS Borders premises.

Responsibility: Borders Community Addiction Team members will carry out Lofexidine detoxifications using the following protocol. This protocol has been used extensively by BCAT and is adapted from similar protocols for Fife, Forth Valley and Tayside NHS Addiction Services.

Exclusions:

• Service users with a diastolic BP below 50 mmHg and pulse rate above 120.

• Hypersensitivity to Lofexidine.

• Severe respiratory and cardiovascular failure.

• Known history of QT interval prolongation.

• Severe renal insufficiency.

• Acute alcoholism or delirium tremens.

• Acute mental health problems especially depressive illness and suicidality.

• Lofexidine is not licensed for use in pregnancy and during breast feeding or in children under 18 years old.

Criteria for community detoxification using Lofexidine:

• Completed a BCAT assessment that includes; mental health assessment, physical health assessment, drug use history and life/ social history.

• Confirmed as opiate dependent and must not be prescribed or taking illicit benzodiazepines.

• The results of a urine specimen taken before prescribing Lofexidine must be available.

• The service user will have provided a drugs diary of not less than one week old.

• Team discussion to establish if Lofexidine prescribing is appropriate and the nature of the continuing treatment programme from BCAT.

Procedure prior to Day 1:

• The initial dose will have been decided by the trained nurse and BCAT prescriber following discussion. The service user will have signed a contract which explains the procedure. A copy of this will be placed in their notes.

• The community detoxification programme will be monitored by the keyworker and Lofexidine prescribed by BCAT. The regime is agreed and the prescription is issued for 10 days to be dispensed on a daily basis by the pharmacist.

• The pharmacy must have agreed in advance to dispense the Lofexidine in the appropriate dosage. A telephone call to the community pharmacist indicating the day’s requirements will facilitate the process.

• It is essential that all service users undergoing this procedure are provided with a copy of the Lofexidine information booklet and the contents discussed prior to and on Day 1 of the procedure. Because of the time available it is also an opportunity to reinforce harm reduction initiatives and undertake motivational work. This will be done by the keyworker.

Procedure Day 1:

• Ensure a current drug diary and recent drug screen result is available.

• Have the service user complete the subjective opiate withdrawal scale (O.W.S.) and the dedicated trained nurse complete the objective O.W.S. (BP, pulse and temperature).

• The initial dose of Lofexidine will be 200 micrograms twice daily regardless of current heroin use (doses to be taken 12 hours apart). The service user will pick-up the Lofexidine and the first dose will be taken in front of the trained nurse.

• Following the initial dose the service user is observed closely for 90 minutes. They will be checked for any signs of distress or light headedness and have their BP checked at half–hourly intervals.

Procedure Day 2:

• CPN will visit the service user at home and the O.W.S. is completed.

• If no signs of withdrawal are apparent then the total dose from Day 1 should be repeated. If obvious withdrawal features are present then the total dose from Day 1 together with an increment of 200- 400 micrograms (1 -2 tablets) should be administered (800 micrograms maximum).

• In all cases service users are monitored for 30 minutes by the trained nurse.

Procedure Day 3:

• Service users should be given Day 2 dosage and an extra 200- 400 micrograms (1-2 tablets) if O.W.S. shows further opioid withdrawal.

• Note- for those being inducted onto Lofexidine from methadone as opposed to heroin (and other short acting opiates) prior to Day 1 methadone dose must be reduced to less than 30ml. Ideally the last methadone dose should be 24- 48 hours before initial dose of Lofexidine.

• Once the trained nurse is satisfied with the procedure, the Lofexidine tablets for self-administration will be handed over to the service user. The service user will also receive Zopiclone 7.5mg for night sedation. Sometimes other symptoms will necessitate the prescribing of:

• Ibuprofen 400mg for muscular aches and pain.

• Hyoscine butylbromide 20mg qds for stomach cramps.

• Metoclopramide 10mg for nausea and vomiting.

• Loperamide 2mg tablets for diarrhoea.

Side Effects from Lofexidine:

• Service users with a systolic BP below 90 mmHg should reduce their dose to 3 tablets bd or lower if they have dizziness at this dose. If in doubt consult the BCAT prescriber. People with a pulse above 120 bpm or below 50 bpm should be discussed with the doctor.

• Lofexidine should not be stopped abruptly as it may cause rebound rise in blood pressure. Reduce to a level at which the service user has no side effects or if they need to stop Lofexidine completely stop over 3 days.

• The importance of close supervision and observation of service users undergoing Lofexidine detoxification cannot be overstated. Any unexplained absences of service users should be a cause for concern and signs of intoxication should prompt and urgent clinical evaluation.

Role of the Detoxification nurse:

• To provide a safe and effective home detoxification programme tailored to meet the needs of the service user who wishes to become free from opiates. Throughout the detox programme the nurse will undertake motivational work exploring issues relating to lifestyle changes which will assist the service user in their goal for abstinence.

• The home detoxification nurse will be seeing the service user every day for the first week, alternate days for the second week and twice for the third week.

4.2 Benzodiazepine Dependence

Introduction: Benzodiazepines were introduced in the 1960’s and quickly replaced barbiturates for the treatment of anxiety and insomnia, as they were thought to be safer and less addictive. The reality now known, is that these drugs are markedly addictive and widely misused. The UK Guidelines (2007) recommend substitute prescribing is not appropriate as there is no evidence to suggest that this regime reduces the harm associated with misuse. Many of the drug deaths in Scotland have opiate plus benzodiazepine positive toxicology, the dangers of overdose from using both in combination cannot be overlooked.

The Committee on the Safety of Medicines (CSM) as reflected in the British National Formulary (BNF) have issued guidance that benzodiazepines should only be prescribed for the short-term treatment of anxiety or insomnia that is severe or disabling and that treatment should last no longer than two to four weeks. The CSM further states that long-term chronic use is not recommended. There is much evidence that long-term prescribing of benzodiazepines causes harm. BCAT does not support initiating substitute prescribing of benzodiazepines. NHS Borders Medicines Management have concerns about the high prescribing of benzodiazepines in primary care and therefore all prescribing from BCAT must adhere to this guideline.

There are a number of diverse presentations in which benzodiazepines may be considered as a prescribed treatment. People presenting to BCAT or requesting prescriptions from GPs/ hospital departments are often using benzodiazepines as an intoxicant but will claim to be ‘dependent’ or ‘addicted’. Dependence to benzodiazepines is very difficult to demonstrate consistently and it is likely that there is significant over-prescribing of benzodiazepines in these circumstances. There is no evidence base to support the prescribing of benzodiazepines as a treatment choice for opiate misuse or benzodiazepine dependence.

In some situations people may be using large amounts and, if stopped may risk withdrawal seizures. This problem may reduce the likelihood of success on a methadone or detoxification programme.

4.2.1 Best Practice Benzodiazepine Treatment in the opiate dependent population

• Clinicians should deal with benzodiazepines in the pre-methadone/ buprenorphine prescribing phase. People should be encouraged to stop using benzodiazepines. This is readily achievable if the drug is being used purely as an additional intoxicant or as a replacement when opiates are not available. In the former, counselling around controlling use of illicit benzodiazepines will augment success while in the latter case, adequate dosing of methadone/ buprenorphine will circumvent the need to use benzodiazepines. Patients should be given access to supportive programmes to deal with issues of insomnia or anxiety. These may include counselling services, complementary therapies or specific self-help programmes.

• If, at the time of consideration of methadone/ buprenorphine prescribing they have proven unable to stop using benzodiazepines then a detoxification prescription may be considered. The following programme is run by BCAT and is recommended. This programme would only be considered if the patient commits to stop their illicit use of benzodiazepines.

o Only diazepam will be used

o No other benzodiazepines will be prescribed

o People will be given no more than 30mg Diazepam on daily pick-up

o Dose will reduce to zero over 12 weeks without exception

o Keyworkers will support and treat the person using alternative strategies

o The regimen will not be repeated

o Universal use of the BCAT benzodiazepine detoxification contract (Appendix 2), setting out expectations of pharmacy, prescriber and service user.

Additional education for primary care colleagues and support from mental health teams should support Benzodiazepine non- prescribing:

• The treatment of anxiety is primarily psychological

• The treatment for misuse of benzodiazepines is primarily counselling

• If patients are misusing benzodiazepines alongside opiates the issue must be addressed pre-prescribing

• Relaxation and sleep hygiene programmes should be available

• If prescribing is deemed necessary it should involve only diazepam, should be low dose, should involve steady reduction (30mg to 0mg over 12 weeks i.e. 5mg/ 2 weeks reduction) and should not be repeated

• The dangers of benzodiazepine prescribing alongside opiates should not be underestimated

4.2.2 Best Practice Benzodiazepine Treatment in the non- opiate dependent population

“There is little evidence to suggest that long-term substitute prescribing of benzodiazepines reduces the harm associated with benzodiazepine misuse and there is evidence that long-term prescribing (especially of more than 30mg diazepam equivalent per day) may cause harm” (UK Guidelines 2007). When faced with “requests to continue a prescription for maintenance benzodiazepines, to prevent withdrawal symptoms it should be continued but gradually reduced to zero” (UK guidelines 2007).

Prescribing benzodiazepines to assist withdrawal should only be initiated when there is clear evidence of benzodiazepine dependency (history, examination, drug diaries and urine toxicology). The aim is for a time limited reduction regime.

If prescribing is deemed necessary it should involve only diazepam, should be low dose (the minimum necessary to alleviate withdrawals), should involve steady reduction (30mg to 0mg over 12 weeks i.e. 5mg/ 2 weeks reduction) and should not be repeated. Diazepam has the advantage of being relatively long acting, is available in different strengths and can be given as a once daily dose.

Long-term effects from benzodiazepines means that all those on a prescription should be reviewed at least three- monthly and treatment goals agreed. Dispensing should take account of helping to avoid street diversion and should most often be daily dispensed and supervised where appropriate (UK Guidelines 2007).

The BCAT benzodiazepine detoxification contract (Appendix 2) or similar should be used, these set out expectations of pharmacy, prescriber and service user. The BCAT version is available and can be adapted for use within primary care settings if requested.

5) Replacement of Prescriptions

Specific guidance has been drawn up for these circumstances following discussion with the local out of hours clinical lead, BCAT and hospital pharmacy and is presented in Appendix 3.

6) Clinical Governance and Quality Standards

Monitoring the quality of prescribing interventions offered is clearly desirable. The Scottish Borders has the advantage of all assessments, initiation and nearly all continuation prescribing occurring through the NHS Borders Addiction Team, BCAT. The following quality standards are expected for all NHS Borders staff undertaking specialist opiate drug treatment prescribing, an annual audit of case notes will monitor compliance:

• Methadone (1mg/ 1ml) mixture and Buprenorphine sublingual tablets are the only medications used as substitute prescriptions in the Borders.

• All cases will be keyworked and appointments will be no less than 4 weekly.

• Prescribing reviews will occur no less than three monthly.

• Recovery care planning will be initiated at assessment and thereafter three monthly until discharge. This will be recorded in the notes.

• Assessment must be completed within 14 days and opiate dependence confirmed prior to starting substitute prescriptions. At least 2 full week drug diaries and 2 drug screens (1 week apart) will be obtained prior to initiating prescribing.

• Once assessed and decision taken to start prescribing this must then occur within 14 days.

• First doses will always be given in safe clinical settings with appropriate clinical staff in attendance.

• Methadone 40 mg should not be exceeded as a first dose. Buprenorphine 8 mg should not be exceeded as a first dose.

• All new prescriptions will be daily supervised consumption for a minimum of three months.

• After three months any decision to reduce the dispensing arrangements for a concession prescription will be discussed with the prescriber and recorded in the clinical notes.

• No replacement prescriptions will be issued (see Appendix 3) .

• All clinical notes will be completed legibly with CHI number, DOB and patient name recorded on every page. Clinical notes will all be signed and designation completed. Borders Risk Assessment Tool and Crisis Card will be completed three monthly or following any change of circumstances. The “parental substance misuse screening tool” will be completed for all service users with responsibility for looking after children at assessment, routinely three monthly and sooner if any change of circumstances.

• A critical incident review will be carried out for any fatality on prescribed medication.

Borders ADP has identified several service level outcomes including reduction in drug related deaths and reduction in BBV transmission. This protocol will ensure consistency of practice and facilitate best practice prescribing occurs to contribute to meeting the ADP strategic targets.

7) References

1. Drug Misuse and Dependence – Guidelines on Clinical Management. Department of health (2007)

2. NICE guidelines methadone/ buprenorphine for opioid dependence (2007)

3. The Road to Recovery (2008) Scotland’s drug strategy.

4. NICE guidelines opiate detoxification (2008)

5. NICE guidelines naltrexone for opioid dependence (2007)

6. Kidd et al (2005) Medical Treatments for drug misusers in Tayside

7. Baldacchino (2001) Guidelines for the management of dependent substance users in Fife

8. Baldacchino (2004) Protocol for Benzodiazepine detoxification

9. Baldacchino (2005) Protocol for Community Detoxification using Lofexidine

10. Ashton (1994) The treatment of benzodiazepine dependence. Addiction 89: 1535- 1541

11. Fatseas et al (2006) Pharmacological interventions for benzodiazepine mono- dependence management in outpatient settings. Cochrane Database of Systematic Reviews, Issue 3.

12. CDPS Induction Document for Medical Staff. NHS Lothian

Appendix 1

NHS Borders Substitute Prescribing Prescription Agreement

Name:…………………………………… D.O.B:……………………… CHI:…………………..

Client Responsibilities

1. To attend all appointments with BCAT/GP, as arranged. If for any reason this is not possible you must notify BCAT/GP before the day of the appointment so that an alternative arrangement may be made.

2. To be forthcoming around any use of substances over and above your prescribed medication.

3. To submit to testing as required.

4. To attend the pharmacy on agreed days and at specified times.

5. Abide by the rules and codes of conduct of the health centre or pharmacy whilst on the premises.

6. To ensure Methadone/Subutex is stored safely in a lockable cupboard out of reach of children.

7. Holiday prescriptions will only be considered when you are stable on your prescription. Please give a minimum of two weeks notice. Evidence of travel may be required.

8. Not to use emergency appointments or house calls to discuss prescriptions and to be responsible for your prescription and medication and recognise that these cannot be replaced. If there are any issues regarding loss or theft etc. of your prescription/ medication these must be discussed with your BCAT keyworker, other health professionals can not replace these prescriptions.

Responsibilities of BCAT/GP and Pharmacist

1. To provide, monitor and dispense the prescription in consultation with the client.

2. To be available at times agreed with the client and provide ongoing support.

3. To liaise with one another regularly as necessary to co-ordinate your care.

4. To determine the frequency of dispensing the prescription.

Responsibilities of All

To ensure that any problems are discussed and resolved at Agreed Appointment Times and afford mutual respect to one another.

Termination of the Agreement

Your prescription is for your own personal consumption. In the event that it is discovered that this is not the case, the prescription will be stopped.

It is at the discretion of your GP/BCAT Doctor whether or not to prescribe to the client, and any abuse or non-compliance with this contract will result in a review of the situation. Specifically clients may be discharged from the service should there be threatening, violent, assaultative or aggressive behaviour directed towards staff, other clients or premises. This decision would be taken by BCAT following a team discussion, and would not be undertaken by individual BCAT/ clinical staff in isolation. Discharge from BCAT under these circumstances would result in reduction and loss of any substitute prescription.

Your GP/BCAT Doctor is not obliged to prescribe any medication if in his/her professional judgement it is not appropriate.

I have read and /or gone over terms of this contact and by signing agree to abide by such conditions as applicable to me. I understand that any infringement of those conditions can result in a cessation of my Methadone/Subutex prescription.

Signed:…………………………………………………. Date: …………………………………...

Your Community Pharmacist and BCAT keyworker have read this contract and have undertaken to abide by the terms as applicable to them.

Signed:…………………………………………………... Date: …………………………………

Your pharmacy is………………………………………………………….

To be completed by Community Pharmacist

You should collect your methadone between……………and………………on the days specified at the inception of your prescription.

Signed: ………………………………………………. (Pharmacist) Date: ……

Appendix 2

NHS Borders

Borders Community Addiction Team

Benzodiazepine Detoxification Contract

Name…………………………………………………………………………….

Date of Birth…………………………………………………………………….

As part of my treatment plan, which includes prescribing diazepam, I agree to the following conditions:

I am currently taking ________mg of diazepam (or equivalent) daily

I agree not to take ANY additional benzodiazepines

I agree not to sell or otherwise dispose of medications prescribed to me

I agree to the tablets being dispensed daily

I understand that the starting dose will be ______ mg and that this dose will be reduced by 5mg every month

I accept that this reduction is fixed and will not be changed

I understand that lost tablets and prescriptions cannot be replaced. Any requests for replacement of lost medication and prescriptions must be with BCAT keyworker and not other healthcare professionals (GPs etc.)

I agree that drug testing for benzodiazepines will show up negative by 1 month after the completion of the diazepam prescribing

Signed…………………………………………………………………………………...

Witnessed……………………………………………………………………………….

Date……………………………………………………………………………………..

Appendix 3

Guidance on Management of Patients Seeking Replacement of Prescriptions for Opiates and Benzodiazepines

Although relatively rare in the Borders area, patients who are dependent on benzodiazepine or opiate drugs approach the OOH services on occasion. This may be because they have (sometimes allegedly) lost or had drugs stolen from them and wish to have them replaced. They may also approach primary care colleagues with similar requests.

These patients can post a significant challenge to all doctors as they often find it difficult to accept a refusal to provide these drugs. This can result in challenging behaviour, which disrupts normal processes in the course of a busy shift.

The concern for doctors is getting the balance right between potential withdrawal symptoms if we don’t prescribe and the risk of appearing to be an ‘easy’ source of these drugs if we do. (This latter practice could then potentially attract a greater number of patients seeking drugs inappropriately via the OOH route).

Some patients seeking drugs will be under the care of BCAT and will therefore have a signed contract (Appendix 1), which precludes them from attending looking for drug replacement. These patients are on a register with BCAT. It is hoped that we can access these register/enter special notes for patients on this register so that such patients are easily identified when they engage with the service.

Dr Mike Kehoe, Consultant Psychiatrist has met with BECS staff and Hospital Pharmacy to discuss how best to manage this cohort of patients. This guidance covers recommendations from that meeting.

The guidance is for patients who are clients of BCAT on methadone programme or benzodiazepine detoxification programme. It could also be used as a guide when dealing with other patients requesting replacement of lost or stolen scripts for these drugs. Obviously each case has to be considered by the individual practitioner and treated as he/she sees fit.

It is important to emphasize that this guidance does not cover those patients taking benzodiazepines for alcohol dependence.

There is specific local guidance (accessible via the intranet) informed by SIGN 74, which includes guidance on the management of alcohol withdrawal. If these patients request replacement scripts/increased doses they should be assessed, as dose adjustments may be required.

The Home Office dislikes replacement prescriptions and this is a valid 'excuse' not to respond to any such requests. A confirmatory police corroboration/ incident record of the theft etc. helps too.

Methadone/ Buprenorphine

a) The relevant BCAT clients have signed a ‘methadone/ buprenorphine or benzodiazepine prescription agreement’. This states that a replacement prescription will not be issued until they have discussed it with their key-worker during working hours. Requests for replacement opiate/ benzodiazepines can therefore be politely declined.

b) Non-BCAT illicit opiate using patients who present requesting opiates should never be prescribed for on the first appointment.

c) Symptomatic treatment with lofexidine could be offered for objectively verified opiate withdrawals, assuming there is the facility to observe post-dose blood pressure (see the Borders Joint Formulary) in very rare circumstances. Although doing this probably just complicates the issue and opiate withdrawal is never life threatening. Benzodiazepine prescribing does not form part of managing an opiate withdrawal.

d) Doctors will at times have to make individual clinical decisions for other requests for opiate replacement prescriptions (e.g. chronic pain patients).

Benzodiazepines:

a) There is nothing to support maintenance benzodiazepine prescribing in the literature. Those in contact with BCAT are again signed up to a ‘benzodiazepine detoxification contract’, which states there will not be a replacement for a lost script until they discuss it with their key-worker in working hours.

There is no shortage of street diazepam and the likelihood of a withdrawal seizure is low given diazepam's long half-life in the short-term- therefore don't feel under pressure to prescribe.

b) In very rare circumstances (e.g. bank holiday weekends), objective withdrawal symptoms could be assessed. Patients can then be observed for a short time to ensure reduction in symptoms following a dose of diazepam.

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