TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (bisoprolol) Bisoprolol (Cardicor ) ® ESCA: For the treatment of heart failure AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of bisoprolol for chronic heart failure can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with heart failure are usually under regular specialist follow-up, which provides an opportunity to discuss drug therapy. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist responsibilities 1 Assess patients suitability for treatment, usually including baseline echocardiography. 2 Discuss benefits and side effects of treatment with the patient. 3 Ask the GP whether he or she is willing to participate in shared care and agree with GP who will discuss the agreement with the patient. 4 Advise the GP how to initiate therapy with dose titration and adequate monitoring. 5 Promptly inform the GP of any results of investigations and changes in treatment following hospital admission or out-patient consultation. 6 Assess potential adverse events and report these to the CSM. 7 Advise the GP on when and how to stop treatment. 8 Ensure clear backup arrangements exist for GPs, for advice and support. General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 Ensure a full understanding of the GP’s responsibilities for managing patients with heart failure on bisoprolol, including dose titration, monitoring and side effects in line with the SPC. 3 Prescribe bisoprolol after communication with the specialist. 4 Assess patient’s clinical status prior to all dose changes. Observe the patient for signs and symptoms of worsening heart failure, monitor BP, heart rate, and weight. Ensure that the patient is clinically stable before increasing the dose. Seek specialist advice if necessary. 5 Refer back to specialist if condition deteriorates, as advised. 6 Report potential adverse events to the specialist and CSM. 7 Stop treatment on advice of specialist, or immediately should the patient’s condition seriously deteriorate (e.g. severe hypotension, cardiogenic shock, symptomatic bradycardia). Patient's role 1 Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to treatment with bisoprolol. 3 Present rapidly to the GP or specialist should their clinical condition significantly worsen, particularly after a dose increase. 4 Report any adverse effects to the specialist or GP whilst taking bisoprolol. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: Email address: Specialist: Hospital Pharmacy Dept: Other: This ESCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 04/07) Original template developed by MTRAC in April 2004 for local adaptation and adoption. TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (bisoprolol) SUPPORTING INFORMATION Licensed indications: symptomatic chronic heart failure Bisoprolol is indicated for the ‘treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction 35%, based on echocardiography) in addition to ACE inhibitors and diuretics and optionally cardiac glycosides’. Dosage and Administration Before treatment is initiated, patients should be stabilised on optimal therapy with ACE inhibitors, and diuretics (and optionally digoxin). Initiation of bisoprolol therapy should be initiated and managed by a GP with a special interes t and experience in the treatment of chronic heart failure, or by a GP with the advice of a specialist, following a thorough patient assessment. Bisoprolol should be introduced gradually to minimise worsening heart failure and ensure a maximally tolerated dose is achieved. The dose must be titrated to individual requirements. The recommended starting dose is 1.25mg once daily for 1 week. With the first dose of bisoprolol, it is recommended that patients be observed over a period of approximately 4 hours, especially with regard to blood pressure, heart rate, conduction disturbances, and signs of worsening heart failure. Blood pressure, heart rate, and clinical status should be monitored after each titration. If 1 week of therapy at 1.25mg once daily is well tolerated increase to: 2.5mg daily for one week, then increase to 3.75mg daily for one week, then to 5mg daily for the following 4 weeks, then 7.5mg daily for the following 4 weeks, then 10mg daily as maintenance therapy. After initiation of treatment with 1.25mg, the patients should be observed over a period of approximately 4 hours (especially as regards blood pressure, heart rate, conduction disturbances, and signs of worsening of heart failure). Therapy should not be stopped abruptly. Contraindications Refer to the SPC. Therapeutic Use Refer to MTRAC VS & SS 04/07. Side Effects Adverse events commonly seen with bisoprolol therapy include dizziness, bradycardia, and hypotension. In some patients heart failure may deteriorate transiently on starting therapy. Close monitoring and where necessary treatment adjustments are advised. Bisoprolol for the treatment of heart failure still has black triangle ( ) status. All suspected reactions (including those considered not to be serious and even where the causal link is uncertain) should be reported to the CSM. Monitoring Parameter Action Blood pressure and CHF In the event of symptoms of worsening CHF adjust the dose or timing of diuretics or symptoms ACE inhibitors. Occasionally it may be necessary to modify or temporarily discontinue bisoprolol treatment (e.g. severe hypotension). The dose of bisoprolol should not be increased until symptoms have been stabilised. Heart rate Reduce the dose of bisoprolol in the event of bradycardia (heart rate < 60bpm). Consider the possibility of drug interactions. Blood glucose Adjust hypoglycaemic therapy as necessary. In diabetic patients Drug Interactions The combination of bisoprolol with the following is not recommended: calcium antagonists clonidine monoamine oxidase inhibitors (except MAO-B inhibitors) Bisoprolol should be used with caution in combination with several other drugs – see the SPC for further details. References MTRAC guidelines VS and SS 02/08. Merck Pharmaceuticals. Summary of Product Characteristics.1999. This ESCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the Midland Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheets (VS & SS 04/07) Original template developed by MTRAC in April 2004 for local adaptation and adoption.