Leicestershire Medicines Strategy Group FULL SHARED CARE AGREEMENT FOR Rivaroxaban in the treatment of Deep vein thrombosis and the prevention of recurrent DVT and PE Prepared by: Dr Jane Strong Consultant Haematologist, Acute DVT service lead On behalf of: NHS Leicester City NHS Leicestershire County and Rutland University Hospitals of Leicester NHS Trust Leicestershire Partnership Trust Date written/reviewed: September 2012 Date of next review: September 2014 Approved by LMSG: October 2012 Version: 1.0 Additional medicines information is available from: Trent Medicines Information Centre Victoria Building, Leicester Royal Infirmary, LE1 5WW Tel: 0116 255 5779 / 0116 258 6491 Fax: 0116 258 5680 e-mail: [email protected] scaF-tmpl-v2 Full Shared Care Policy for the prescribing of Rivaroxaban in the treatment of deep vein thrombosis and the prevention of recurrent DVT and pulmonary embolus Introduction and purpose This shared care agreement has been produced following classification of Rivaroxaban in the Leicestershire drug traffic light scheme. See website at www.lmsg.nhs.uk Shared care has been defined as the mechanism of sharing patient care between primary and secondary care providers. This document sets out these responsibilities from initial diagnosis to on going support. Disease Background Acute DVT is a common and potentially life threatening disorder. It has an incidence of around 1:1000 patients per year, the incidence increasing with age (Winter et al, 2005) Uncomplicated DVT is now widely managed on an outpatient basis and most patients can be treated at home without problems (Winter et al, 2005) This positively contributes to the drive to reduce pressure on acute hospital beds and importantly reduce the time that patients have to spend waiting in A&E or MAU. NICE CG144 and TA 261 contain evidence based guidance on the assessment, diagnosis and treatment of suspected and proven DVT. Drug covered by the agreement Rivaroxaban (Xarelto®) is a specific inhibitor of activated factor Xa with excellent oral bioavailability and a half life of approximately nine hours. NICE TA261 – Rivaroxaban for the treatment of DVT and prevention of recurrent DVT and PE recommends rivaroxaban as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after the diagnosis of acute DVT in adults. It has potential advantages over warfarin of not requiring INR blood monitoring, but other factors about rivaroxaban need to be taken into consideration when deciding whether it is appropriate for an individual patient. Secondary Care Clinician Responsibilities • Diagnosis of condition and ensuring other treatment options have been fully explored • Ensuring patient selection criteria as stated in UHL DVT Process for supply • Completion of the Rivaroxaban in DVT New Patient Request Form available at http://www.lmsg.nhs.uk/LMSGDocs/Guidelines/Rivaroxaban(DVT)-newpatient_request_form_Oct12_V1doc.doc • Discussion of risks/ benefits, initiation of treatment, referral to anticoagulation specialist nurse for counselling* • Advising GP on monitoring adverse drug reactions ( ADRs) • Liaison with the general practitioner (GP) to share the patient’s care using the Shared Care Agreement Form: Shared Care Agreement Form. Shared care should not be assumed until a written agreement has been received from the GP. • Outlining to GP date when therapy should be reduced or stopped assuming no relapse in patient’s condition. Review periods to be agreed. • Responding to issues raised by GP after care of patient has been transferred • Advising GP of information sources for further guidance on drug interactions, adverse effects etc. Page 2 of 3 *Anticoagulation specialist nurse will • Counsel patient, providing information leaflet and anticoagulation card • Telephone patient after approximately 7 working days to ascertain tolerability • Feedback/liaise with appropriate secondary care consultant so shared care request can be initiated if there are no problems or liaise to resolve any problems identified. GP Responsibilities • Confirm or decline request to share patient’s care as soon as possible, using the shared care agreement form. • Monitoring the patient’s overall health and well being and observing patient for evidence of ADRs/abnormalities and raising with secondary care clinician if necessary. • Clinical surveillance in line with anticoagulation practice throughout the treatment period Assessment of renal function at least once a year, or more frequently as clinical circumstances dictate when it is suspected that renal function could decline or deteriorate. Annual review as appropriate to include o History of any venous thromboembolic event in last year o Reassessment of bleeding risk Prescription of drug after initiation by secondary care Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient’s physical health status Reducing/stopping treatment in line with secondary care clinician’s original request • • • • • Patient Responsibilities • Attendance at initial counselling session • Report untoward effects to prescribing clinician • Compliance with treatment • Compliance with blood tests as detailed by prescribing clinician • Informing other professionals as appropriate that they are receiving an anticoagulant. Prescribing & Clinical Information Summary Summary of Product Characteristics (SPC) Xarelto (Rivaroxaban), Bayer. Available from e-MC at http://emc.medicines.org.uk/ BNF prescribing information available at http://bnf.org/bnf/ Contact for support and advice Consultant Haematologists (Dr J Strong, Dr S Pavord, Dr P Mensah, Dr R Gooding) Haemophilia Centre, LRI Fax 0116 258 5093 Stuart Brown, Lead Anticoagulation Nurse Practitioner UHL-CAS LRI Tel: 0116 2585096 1030-1530hrs Mon-Fri except BH and weekends Fax: 0116 2587561 Email [email protected] Page 3 of 3
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