TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (atomoxetine) Atomoxetine (Strattera®▼) ESCA: For the treatment of attention deficit / hyperactivity disorder AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of atomoxetine for ADHD 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 is usually explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. 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 Initiate atomoxetine and stabilise patient on maintenance dose. 2 Discuss the 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 the GP as to who will discuss the shared care arrangement with the patient. 4 Communicate promptly with the GP when treatment is changed. 5 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 6 Agree a medication review date with the GP and give advice on stopping treatment. 7 Report adverse events to the CSM. 8 Ensure that clear backup arrangements exist for GPs to obtain advice and support. General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 Prescribe atomoxetine at the dose recommended. 3 Adjust the dose as advised by the specialist. 4 Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment. 5 Refer patient to the specialist if his or her condition deteriorates. 6 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 7 Report adverse events to the specialist and CSM. Patient's role (or that of carer) 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 atomoxetine. 3 Report any adverse effects to the specialist or GP whilst taking atomoxetine. 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 Midlands Therapeutics Review and Advisory Committee (MTRAC) verdict & summary sheet (VS06/13) Template updated by MTRAC in June 2006 for local adaptation and adoption. TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (atomoxetine) SUPPORTING INFORMATION Licensed indications Atomoxetine is licensed for the treatment of attention deficit / hyperactivity disorder in children and adolescents. Dosage and Administration The Summary of Product Characteristics (SPC) states that treatment must be initiated by or under the supervision of a physician with appropriate knowledge and experience of childhood behavioural disorders. Atomoxetine is available as capsules to be taken orally. It is normally given as a single dose in the morning. Patients who suffer from side effects may benefit from dividing the dose, which should then be taken in the morning and late afternoon or early evening. In children and adolescents under 70 kg body weight, atomoxetine should be initiated at a total daily dose of 0.5 mg/kg, maintained for at least seven days. The dose should then be titrated upwards according to response and tolerability to the recommended maintenance dose of 1.2 mg/kg/day. In children and adolescents over 70 kg body weight and adults the initiation and recommended maintenance doses are 40 and 80 mg daily, respectively. In patients with moderate and severe hepatic insufficiency doses should be reduced to 50% and 25% of the standard dose, respectively. No adjustments are required for those with renal insufficiency. Monitoring The patient’s blood pressure, heart rate and growth parameters should be monitored, especially in the early stages of treatment. Contraindications Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs), or within two weeks after discontinuing therapy with a MAOI. Treatment with a MAOI should not be initiated within two weeks after discontinuing atomoxetine. See the SPC for further details of contraindications. Therapeutic Use Refer to MTRAC VS 06/13. Side Effects The most commonly reported adverse events in clinical trials were headache, rhinitis, abdominal pain, pharyngitis, anorexia, vomiting, cough, somnolence and insomnia. Small increases in blood pressure, both diastolic and systolic (about 2 to 3 mm), and pulse rates (about 6 to 9 bpm) were seen in the groups taking atomoxetine. Significant decreases in weight (of about 0.5 to 1.0 kg) were reported with atomoxetine in most studies. See the SPC for further details on adverse effects. The Commission on Human Medicines has advised that atomoxetine should be prescribed with caution in patients with a history of seizure or at risk of prolonged QT interval. Reports of an increased risk of suicidal thoughts and rare hepatic disorders have also emerged since atomoxetine was launched. Atomoxetine was launched in 2004 and has black triangle (▼) status. All suspected reactions (including those considered not to be serious and where the causal link is uncertain) should be reported to the CSM. Drug Interactions Specific interactions have not been reported. The SPC recommends that the following drugs be used with caution if co-administered with atomoxetine because of potential or theoretical drug interactions: CYP2D6 inhibitors, salbutamol, pressor agents, and drugs that affect noradrenaline. Cost At current prices one year’s treatment with atomoxetine 80 mg daily costs £1,566. References MTRAC guidance VS06/13. Eli Lilly. Strattera. Summary of Product Characteristics 2004. Commission on Human Medicines. CEM/CMO/2006/03 Strattera (atomoxetine) – conclusions of risk:benefit review. Dear Colleague Letter, February 2006. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023222&ssTargetN odeId=221. Accessed 30/05/2006. This ESCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the Midlands Therapeutics Review and Advisory Committee (MTRAC) verdict & summary sheet (VS06/13) Template updated by MTRAC in June 2006 for local adaptation and adoption.
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