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Specification for Pharmacy Supervised Consumption 1. Introduction This document sets out a service specification for a community pharmacy ‘supervised consumption’ service to be provided by the contractor to service users who are prescribed methadone or buprenorphine and will encompass supervised support and advice to service users in a safe environment. The practice is designed to support service users to stop or stabilise their opiate use thus enabling them to develop their personal goals. For the purpose of the agreement ‘supervised consumption’ is defined as the observed consumption, by the pharmacist or a suitably trained technician, of prescribed substitute medication for opiates where supervision has been requested by the prescriber. The service is available and limited to patients receiving methadone or buprenorphine for the treatment of opioid dependence from Turning Point Leicester & Leicestershire or an accredited GP participating in L&L Shared Care Scheme. This service is for service users of 18 years and above. 2. Aims It is expected that dispensing and supervised consumption will ensure compliance with the agreed treatment plan by: Dispensing prescribed medication in specified instalments. Ensuring each supervised dose is correctly administered to the patient for whom it was intended (doses may be dispensed for the patient to take away to cover the days the pharmacy is closed) in accordance with the prescription. Monitoring the patient’s response to prescribed treatment for example if there are signs of overdose, especially at times when doses are changed. Liaising with the prescriber or named Turning Point worker as appropriate, if the patient appears intoxicated or when the patient has missed a dose, and, if necessary withholding treatment if this is in the interest of patient safety. Improving retention in drug treatment. Improving drug treatment delivery and successful exit from treatment. Help service users’ access treatment by offering referral to specialist drug and alcohol treatment centres and health and social care professionals where appropriate. Reduce the risk to local communities of diversion of prescribed medicines onto the illicit drugs market and contribute to a reduction in drug related deaths in the community 3. Service Outline Page 1 of 11 This is a multidisciplinary approach to prescribing (including GP shared care prescribing) which is carried out in line with recommendations of Drug misuse and dependence guidelines on clinical management (DH 2007) and other central guidance and includes the patients pharmacist. a) For the purposes of this specification, medicines for the management of opiate dependence which may have consumption supervised include: o Methadone o Buprenorphine o Buprenorphine/Naloxone (trade name Suboxone) b) The trained pharmacist or a suitably trained technician are required to supervise the consumption (when prescribed or required) of the prescribed oral medicine (e.g. methadone or buprenorphine) at the point of dispensing in the pharmacy, ensuring that the dose has been consumed by the patient. For methadone it is expected that the patient should be asked to drink some water and speak after the dose to demonstrate the dose has been swallowed. For buprenorphine 3 minutes should be spent supervising the patient as dissolution of the sublingual tablets may take several minutes, alternatively the tablets may be crushed in accordance with local protocols. c) Pharmacy staff providing supervised consumption services will provide a user friendly, nonjudgmental, client-centred and confidential service. d) The pharmacist/technician ensures that supervised consumption takes place in a private or quiet area of the pharmacy identified as safe to staff and agreeable to the patient. e) Pharmacist/technician provides service users with information about their medicines and appropriate health promotion materials. f) The pharmacy will promote safer practice to the user, including advice on sexual health and STIs, HIV and Hepatitis C transmission and Hepatitis B immunisation. g) Pharmacists and their staff providing dispensing supervised consumption services for drug users have standard operating procedures in place for their individual premises. h) Pharmacy staff abide by local arrangements for clinical governance. i) Pharmacies receive prompt payment for the services provided. 4. Service Description a) Also refer to Appendix 1 - Roles and Responsibilities. b) The part of the pharmacy used for provision of the service provides a sufficient level of privacy and safety and meets other locally agreed criteria. c) The pharmacy will present the medicine to the service user in a suitable receptacle and will provide the service user with water to facilitate administration and/or reduce the risk of doses Page 2 of 11 being held in the mouth. d) Terms of agreement are set up between the prescriber, pharmacist, patient and specialist service to agree how the service will operate, what constitutes acceptable behaviour by the client, and what action will be taken by the GP and pharmacist if the user does not comply with the agreement. e) Patients are prepared for the provision of substitute medications by the specialist drug services and this should be reinforced by pharmacists, this includes providing advice and written information about methadone, buprenorphine or other pharmacotherapy, alcohol use, risk of overdose, loss of tolerance following missed or uncollected doses, drug interactions, an explanation of supervised consumption and where and how this will occur, as well as opening and closing times. This information in relation to service opening times will be made available to pharmacies. f) Missed doses – Please advise the prescribing agency when a client has missed a dose. They may be aware of the reasons and be able to authorise the next instalment of the prescription, or require the client to make contact with them first. Please see Appendix 3 - Missed Dose Reporting Flowchart. g) If a client has missed three consecutive doses you should not dispense, you should contact the prescribing agency. If a client has a pattern of non-attendance, e.g. always missing the same day or regularly missing days each week you should also advise the prescribing agency as their prescription/dispensing arrangements require review. Please see Appendix 3 - Missed Dose Reporting Flowchart. h) Information sharing – screening, risk assessment and referral: Pharmacists feedback appropriate information to Turning Point with the agreement of the patient, in accordance with their professional code of practise and local shared care agreements. This includes any concerns around the welfare of a child. Pharmacy service providers make a clinical judgement as to when it may be appropriate to withhold a dose, e.g. during dose titration, if the patient is intoxicated with drugs and alcohol, if there are signs of overdose, if the patient has missed one days prescribed treatment, or if the pharmacist has concerns about the patients safety. Referral to appropriate services. i) Pharmacist legal and professional responsibilities: Ensuring the legality of the prescription and correctness of detail. Registering the patient onto the standard Patient Medication Record. Dispensing the medicine in accordance with the prescription system. Explaining that missed doses cannot be collected the next day. Following local agreed arrangements allowing the dispensing and supervised consumption of doses not collected on specified days – in accordance with Home Office guidance on instalment prescribing. Pharmacy service providers co-operate with Leicestershire Constabularies Controlled drug liaison officers, the GPhC and Public Health, County Council. Compliance with current legislation, including the Medicines Act 1968, Misuse of Drugs Act 1971, Misuse of Drugs Regulations 2001 as amended, Misuse of Drugs (safe Page 3 of 11 custody) regulations 1973, National Health Services (pharmaceutical services) regulations 2005. 5. Accreditation a. Pharmacists and staff involved in the provision of the service have relevant knowledge and are appropriately trained in the operation of the service to a standard agreed with Turning Point. Training in the operation of the service is provided by Turning Point in the form of guidance, protocols and local workshops. b. Pharmacists and staff involved in the provision of the service are aware of and operate within local protocols agreed with Turning Point. The Pharmacies SOP must be based on the local protocols of this service and must be regularly reviewed. c. Providers will attend at least one meeting per year with Turning Point to promote service development and update the knowledge of pharmacy staff. This includes an awareness raising session about the drug and alcohol treatment and support services available locally and an opportunity to raise questions and/or concerns about practice. 6. Support To ensure the effective management and development of supervised consumption (including appropriate support for pharmacies) the following Turning Point staffing structure will be in place: Countywide Pharmacy Lead to oversee the contract sign up and performance monitoring and quality assurance Countywide Administrator to validate claims and support process of payments Locally based Harm Reduction Leads and (Senior) Recovery Workers to ensure training, support and develop provision to meet the needs of the county and to act as a single point of contact for pharmacy referrals and guidance Any queries can also be directed to the dedicated Harm Reduction e-mail address: [email protected] 7. Performance and Quality Monitoring a) The pharmacy must maintain appropriate records on Neo to ensure effective on-going service delivery and audit. b) The pharmacy must review its standard operating procedures and the referral pathways for the service on an annual basis. c) Turning Point reserves the right to request evidence or information that the contractor is providing the service in a way that is safe, convenient and in accord with the requirements of this specification. The contractor is required to comply with all reasonable requests for evidence or information. This includes a closer review of data, ordering process, storage, safe storage and patient feedback. Page 4 of 11 d) The pharmacy participates in an organised audit of service provision and co-operates with any locally agreed Turning Point or Public Health led assessment of service user experience. Ad hoc mystery shopping will sample quality of advice and inform training needs and service development. e) Turning Point will undertake an annual audit to review quality of provision which may include the following performance and quality measures: Service activity – volume of work as measured by data in Neo Clinical outcomes – measured via the review process and by analysis of data i.e, Neo and Turning Point’s client database Quality and governance – training attendance and compliance with local procedures i.e, missed dose reporting compliance Patient experience – service user views on their experiences and satisfaction levels measured through Turning Point service user involvement mechanisms i.e, mystery shopping Value for money – services will be reviewed against activity levels, quality, outcomes and payments made to determine ’value for money’. This will link to the quarterly monitoring and annual review Page 5 of 11 Schedule 1 Payments Payment process Neo has been commissioned by Turning Point to act as an agent for processing the claims. Under this agreement Neo is funded to provide access to Neo to pharmacies commissioned to provide the supervision/needle syringe exchange services and process service payments on behalf of Turning Point. Monthly claims are now completed via the Neo system. Claims must be submitted via Neo within a 2 month grace period or contractors will not receive payment. Paper-based claims will not be processed for payment. For queries relating to the use of Neo please contact: L&L Pharmacy Lead(s) – 0300 3036000 Payment rates Supervision eligible for payments will be made to the Pharmacy at the following rates: £1.50 per administration of Methadone £2.50 per admission of Buprenorphine and Buprenorphine/Naloxone Page 6 of 11 Schedule 2 Guidelines for the Pharmacist National guidelines Drug Misuse and Dependence: UK Guidelines on Clinical Management 2007: http://www.nta.nhs.uk/uploads/clinical_guidelines_2007.pdf NICE Drug Misuse guidance & guidelines page: https://www.nice.org.uk/guidance/health-protection/drug-misuse NICE Pharmacological Interventions in Opioid Detoxification for Drug Misuse treatment pathway: http://pathways.nice.org.uk/pathways/drug-misuse#path=view%3A/pathways/drugmisuse/pharmacological-interventions-in-opioid-detoxification-for-drugmisuse.xml&content=view-index NICE (2007) Drug Misuse – Opioid detoxification clinical guidance: https://www.nice.org.uk/guidance/cg52 Non-medical prescribing, patient group directions, and minor ailment schemes in the treatment of drug users, NTA, 2007: http://www.nta.nhs.uk/uploads/nta_non_medical_prescribing_1207.pdf NICE (2010) Pregnancy and complex social factors: a model for service provision for pregnant women with complex social factors: https://www.nice.org.uk/guidance/cg110 For Pharmacy Teams: CPPE open learning package on Substance Use & Misuse: https://www.cppe.ac.uk/learningdocuments/pdfs/substanceuse_ol.pdf Local Guidelines Countywide contact details Single Point of Contact Phone: 0330 303 6000 For the purposes of the specification please refer to: Appendix 1 (Roles & Responsibilities) Appendix 2 (Missed Dose Reporting Flowchart & Contact Numbers) Appendix 3 (Example Pharmacy SOP) Appendix 4 (Countywide Referral Form) Your local Turning Point Harm Reduction Lead will also be able to provide you with ongoing access to updated best practice guidance, training and support as service provision is developed. All up to date guidance documents will be available on the LPC website and Neo. Page 7 of 11 Appendix 1 – Roles and Responsibilities TP Roles & Responsibilites - Supervised Consumption Appendix 2 – Missed Dose Reporting Flowcharts & Contact Numbers Missed Dose Reporting Flowchart & Contacts Appendix 3 – Example Pharmacy SOP Pharmacy SOP Example Appendix 4 – TP Countywide Referral Form Page 8 of 11 Turning Point Leicester & Leicestershire Adult Referral Form 0330 303 6000 [email protected] Client Details Title: ☐Mr ☐Mrs ☐Miss Ms Other: Address: Name: Postcode: Area of Residence: Referral Date: ☐ D.o.B: Gender: ☐Male ☐Female Other: Telephone: ☐Transgender Mobile: Email address: City ☐ Loughborough ☐ Coalville ☐ Rutland ☐ Accommodation Status: ☐No Housing Problem ☐Housing Problems ☐Homeless If Homeless, please advise how we can make contact, include Chain no. if known: How would the client like to be contacted? ☐Phone ☐Text ☐Letter ☐e-mail ☐Other (please specify) Black/African/Caribbean/Black Ethnic Origin: White: ☐British/English/Welsh/Scottish ☐Irish ☐Gypsy/Irish Traveller ☐Any Other White Background Asian or Asian British: ☐Indian ☐Pakistani ☐Bangladeshi ☐Chinese ☐Any Other Asian Background British: ☐Black African ☐Black Caribbean ☐Any Other Black Background Other Ethnic Group: ☐Arab ☐Any Other Ethnic Background (please specify): Mixed: ☐White & Black ☐White & Black African ☐White & Asian ☐Any Other Mixed Background Does the client require an interpreter? ☐Yes ☐No (If Yes, please specify language): Does the client care for any children under 18? ☐Yes ☐No Does the client consider themselves to have a disability? ☐Yes ☐No (If Yes, please provide details): GP Name and Address: Does the client give consent for us to share information with the GP? ☐Yes Referrer’s Details Name: Agency Name: Address: Telephone: Fax: Email: Postcode: Page 9 of 11 ☐No Is the client aware of the referral? ☐Yes ☐No Can we use your premises to conduct appointments with this client? ☐Yes Would you like feedback on the outcome of this referral? ☐Yes ☐No How did you hear about the Service? ☐No Reason for the referral: Alcohol Use: Questions 0 1 Scoring System 2 3 4 Your Score How often do you have a drink Monthly or 2-4 times 2-3 times 4+ times a Never containing alcohol? less a month a week week How many units of alcohol do you have on a typical day when you are 1-2 3-4 5-6 7-9 10+ drinking? On a single occasion, how often Daily or have you had: Less Than Never Monthly Weekly Almost 6 or more units if you are female? Monthly Daily 8 or more units if you are male? NB: A total Score of 5+ indicates increasing/higher risk drinking YOUR TOTAL SCORE: 1 Unit of Alcohol More than One Unit of Alcohol 30 Bottle of Spirits Drug Use: If Yes please specify: Substance ☐Benzodiazepine ☐Cannabis/Skunk ☐Cocaine ☐Crack Cocaine ☐Crystal Meth ☐Ecstasy ☐GHB ☐Heroin ☐Methadone ☐Novel Psychoactive Substances ☐Steroids Other (please specify): Frequency of use ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly ☐Daily ☐Weekly Method of Use ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Fortnightly ☐Daily ☐Weekly ☐Fortnightly ☐Daily ☐Weekly ☐Fortnightly ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Not Currently Using ☐Smoke ☐Oral/Snort ☐Inject ☐Monthly ☐Not Currently Using ☐Monthly ☐Not Currently Using ☐Smoke ☐Oral/Snort ☐Inject ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Monthly ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject ☐Smoke ☐Oral/Snort ☐Inject How long has drinking and/or drug use been a problem (please specify weeks/months/years)? Cocaine 8-9 grams weekly Please list any medications and reason for taking them? Page 10 of 11 Risk and vulnerabilities: Are there any risks that we should be aware of? ☐Yes ☐No If Yes please provide details (e.g. alcohol/substance related, mental health, suicide/self-harm, risks from others, child safeguarding): C For referring agencies, please provide a current risk assessment: Page 11 of 11 ☐Attached ☐Not attached