Submission to Medicines Management Committee Date of Meeting: Person presenting at meeting: Agenda No: Attachment: Medicines used for abstinence (naltrexone, Purpose of Report: disulfram, acamprosate) or harmful drinking Support the transfer of prescribing reduction (nalmefene) responsibility and care for abstinence and harmful drinking Transfer of Prescribing Responsibility Report Author: Submitting Team/Organisation: SWLStG DTC KCCG Med Mgt team Contact details: Carl.holvey@nhs.net Executive Summary: (precise purpose of document) Describes how medicines for abstinence and reduction of harmful drinking are initiated and reviewed across South West London which are complicated due to the complex commissioning arrangements of the services that support their use. Key sections for particular note (paragraph/page), areas of concern etc: Note that most DARTs are not currently commissioned to see patients who would qualify for the use of nalmefene for harmful drinking. They are currently seen by GPs and not referred. GPs can initiate this medicine and refer directly for psychosocial support to the local recovery teams. The level of psychosocial support needed for nalmefene to be effective is below the high level given by NHS support services (as per NICE). Recommendation(s) for the committee: Review on discussion with public health commissioners. Committees which have previously discussed/approved/declined the report and/or Leads who have been consulted and key outcomes: Psychiatrists at Sutton, Merton, Richmond and Kingston (CANDI FT) DARTs are in agreement with the principals of this document. Wandsworth CCG are in discussions with its providers and public health. Financial Implications: Nalmefene 18mg tablets = £42.42 for 14 tabletsi Other Implications if applicable: N/a How will this document be disseminated and to whom? CANDI DART, SLaM DART, SWLStG DARTs, CCG MMCs SWLStG DTC, SWL Public health teams Prescribing Guidelines for Medicines used for abstinence (Naltrexone, Disulfiram, Acamprosate) or harmful drinking reduction (Nalmefene) v1.0 Medicines used to help patients sustain abstinence from alcohol 1st line: Acamprosate is by far the most commonly prescribed medicine and is useful for those experiencing cravings for alcohol. Disulfram is most useful for stable patients who need a further deterrent as severe side effects are experienced should someone drink alcohol while being prescribed. Naltrexone can be used as per NICE along with psychosocial intervention to reduce the risk of relapse, as support treatment in abstinence and to reduce the craving for alcohol. It is also a full opiate blocker. Following detox, medicines for abstinence may be initiated by a Drug and Alcohol Team (DART) or after inpatient admission (Crawley Hospital or Kingston) in those that are willing and feel they would benefit. Service users are transferred to the community psychosocial team; there is no further medical input required from the treatment team at this point. If needed, medical advice and support can be obtained from DART and the supply is sourced from their GP. Nalmefene is as a possible treatment for people with alcohol dependence whoii&iii: o are still drinking more than 7.5 units per day (for men) and more than 5 units per day (for women) 2 weeks after an initial assessment and o do not have physical withdrawal symptoms and o do not need to either stop drinking straight away or stop drinking completely. o These patients do not necessarily require a detox and do not meet the thresh hold to be seen by most alcohol treatment teams. Those requiring medicines for detox (i.e. chlordiazepoxide) are not initially suitable for nalmefene. This product requires extra monitoring, report adverse effects to the MHRA: www.yellowcards.gov.uk Nalmefene should be taken at a dose of 18mg 1-2hrs before the anticipated time of drinking. Prescribe 18mg each day, when required, supply 14 doses in 28 days, with a maximum supply of 6 months to ensure it is reviewed. Should the harmful drinking have not improved at 6 months, nalmefene should be stopped and alternatives considered. Those requiring daily administration of nalmefene should be considered for a switch to naltrexone 50mg daily (unlicensed), which has evidence to support abstinence maintenance and is a more cost effective alternative. Psychosocial support All medicines list above have been shown to be effective and licensed when given in combination with psychosocial input. Psychosocial input can be from the Substance Misuse Recovery Teams (SMRTs) and/or Mutual Aids Groups such as Alcoholics Anonymous (AA). The level of psychosocial support given by SMRTs is to NICE standards which are more in depth then the brief interventions undertaken in clinical trials with nalmefene. Specialists initiating medicines for abstinence in initiating medicines for abstinence and harm reduction will refer for psychosocial support and communicate to GP the care plan (including investigations, recommended monitoring and review) for continued supply of medicines. GPs can refer patients for 12 weeks support (as per NICE) directly for those started on nalmefene by them: Sutton (CDS), T:020 8773 9393 & E:franco@cdssl.org Merton (MACS Project), T: 0800 043 2296 (free) or 020 8417 1960/ 0208 417 1975/ 0786 604 5624. Richmond (CRI), T:020 8891 0161,M:07795 391 187, F:020 8892 3363 & E:richmond.info@cri.org.uk Kingston (Wellbeing Service) T: 020 8274 3051 or E:kingston.wellbeingservice@nhs.net The community psychosocial team acknowledges the referral and will continue communicating with the GP with the progress of the service user under their care. They will inform the GP should the patient disengages from the programme as nalmefene should be discontinued. GP monitoring & review requirements Medicines for abstinence and harm reduction require very little medical review (alcohol consumption, overall functioning and side-effects). They should be continued for 6 months to 1 year, or indefinitely if the patient continues to derive benefits and remains abstinent from alcohol, or reduced harmful drinking with nalmefene. Disulfram cannot be combined with alcohol, acamprosate and naltrexone can be given up to one month if someone relapses back to alcohol use. Nalmefene should be discontinued if the patient does not experience a reduction in their harmful drinking at 4 weeks. Useful references Information on medicines for substance misuse (and mental health) may be found on the information website: http://www.choiceandmedication.org/swlstg-tr/ https://www.nice.org.uk/guidance/ta325 - Nalmefene www.nice.org.uk/guidance/CG115 - Alcohol use disorders http://www.medicines.org.uk/emc/ - Summary of Product Characteristics (for Medicines) Other Clinical Particulars This table is not exhaustive; www.emc.medicines.org.uk see individual SmPCs for full prescribing details. *Refer back to a specialist or contact Specialist Medicines Information (020 3513 6829) for review/advice if the medicine(s) if needed. Management of side-effects Side-effect Acamprosate Diarrhoea, stomach flatulence Opioid receptor modulators (naltrexone /nalmefene) Disulfram Management nausea Usually self-limiting, supportive advice usually pain, sufficient: drink plenty of fluids, oral rehydration salts or take with food for nausea. Slow titration, reducing the dose temporarily Headaches and paracetamol may all help. Anorgasmia, decreased Try decreasing the dose or stop* libido Allergic reaction: ash, Stop, refer to physician for treatment. pruritus, wheeze Arrhythmias Switch.* Nausea, vomiting, Advise take with largest meal of the day, abdominal cramps, responds to dose reduction. Self-limiting, diarrhoea occurs in the first 24hrs usually. Self-limiting, simple analgesia. Stop if it does Headache not resolve. Muscle pain Wears off after 1 week polydipsia Consider dose reduction Rash, pruritis Stop* Depression, suicidal Stop* ideation hallucinations Stop* thrombocytopenia Stop* Increase frequency of monitoring, consider reducing the dose for twice the upper limit and Liver damage stopping the medicines for three times the upper limit Sleepiness and fatigue Usually on initiation or dose increase. Halitosis Usually self-limiting on initiation. Nausea & vomiting Advise on taking with food or reduce the dose. Shortness of breath Stop* Allergic skin reactions Antihistamines help or stop* Decreased libido Stop or consider dose reduction* Increase frequency of monitoring, consider Liver damage reducing the dose for twice the upper limit and (hepatitis) stopping the medicines for three times the upper limit Peripheral neuropathy Decreasing the dose can help or stop* High or low mood or Stop* psychotic symptoms Interactions Clinical meaningful interactions to note with other medicines are rare with these medicines, review the SmPC should adverse effects occur. Caution when combining strong opioids with naltrexone or nalmefene due to the risk of respiratory depression. Disulfiram should not be combined with alcohol. Assessment of the risk of this should be done with the patients before it is initiated. References i NHS Electronic Drug Tariff April 2015. Available [Online] via: http://www.ppa.org.uk/edt/April_2015_v2/mindex.htm (Accessed 8th April 2014). ii http://www.nice.org.uk/guidance/ta325/resources/guidance-nalmefene-for-reducing-alcohol-consumption-in-peoplewith-alcohol-dependence-pdf iii London New Drugs Group / London Medicines Evaluation Network Review. Nalmefene for alcohol dependence. October 2013. Available [Online] via: http://www.medicinesresources.nhs.uk/upload/Nalmefene_final.pdf (Accessed 7th April 2014)