Shared Care Guideline Atomoxetine for Adult ADHD SHARED CARE AGREEMENT ATOMOXETINE for ADULT ADHD Version: Date: Author: Status: Comment: 1 01/2014 Tracey Green Draft Dr Saif Sharif Document Author Written by: Tracey Green Signed: Date: 15/07/2013 Job Title: Pharmacist Mental Health Approval DAC: 07/03/14 Trust Executive Committee date: April 2014 CCG Board date: April 2014 Review Date: March 2016 Effective Date: March 2014 Version Control History: Version: Date: Author: Status: Comment: 1 March 2014 Tracey Green Approved Dr Saif Sharif Shared Care Guideline February 2014 Isle of Wight NHS Trust 01983 524081 Lead Consultant Dr Saif Sharif Lead Nurse Lead Pharmacist Tracey Green Medicines Information 01983 534622 NB: This Shared Care Agreement relates to the Isle of Wight NHS Trust hereafter referred to as the Trust. This shared care guideline has been produced to support the seamless transfer of prescribing and patient monitoring from secondary to primary care and provides an information resource to support clinicians providing care to the patient. It does not replace discussion about sharing care on an individual patient basis. This guideline was prepared using information available at the time of preparation, but users should always refer to the manufacturer’s current edition of the Summary of Product Characteristics (SPC or “data sheet”) for more details. The Trust holds full responsibility for any adverse events preventable by monitoring stated within the agreement at all times that prescribing continues within the limits set by the agreement. Shared Care Guideline February 2014 2 CONTENTS PAGE SECTION DESCRIPTION PAGE 1 INTRODUCTION 4 2 INDICATIONS 4 3 PREPARATION 4 4 SAFETY ISSUES 5 4.1 Dose 5 4.2 Contra-indications (also see current BNF or SPC) 5 4.3 Cautions 5 4.4 Common Side Effects (also see current BNF or SPC) 5 4.5 Drug Interactions (also see current BNF or SPC) 5 4.6 Pre-treatment Assessment 6 4.7 Routine Safety Monitoring 6 5 RESPONSIBILITY OF CONSULTANT 6 6 RESPONSIBILITY OF NURSE (if applicable) 6 7 RESPONSIBILITY OF GP 6 8 RESPONSIBILITY OF PATIENT 6 9 FURTHER INFORMATION 7 10 CONSULTANT LETTER 8 11 GP RESPONSE FAX FORM 9 12 EQUALITY ANALYSIS & ACTION PLAN 10 Shared Care Guideline February 2014 3 1 INTRODUCTION ADHD is a behavioural syndrome characterised by the core symptoms of hyperactivity, impulsivity and inattention. Symptoms of ADHD can overlap with symptoms of other related disorders, in adults they include personality disorders, bipolar disorder, obsessive compulsive disorder and substance misuse. (1) ADHD is thought to affect about 3–9% of school-age children and young people in the UK, and about 2-4% of adults worldwide, including the UK, Adult ADHD is widely under-recognised. Most young people with a diagnosis of ADHD will go on to have significant difficulties in adulthood, which may include continuing ADHD, personality disorders, emotional and social difficulties, substance misuse, unemployment and involvement in crime. (1) It is suggested that ADHD in childhood can persist into adulthood in at least 30% of patients. Adults may receive a first diagnosis of ADHD having never been diagnosed as a child but have a history of symptoms Drug treatment is the first-line treatment for adults with ADHD with either moderate or severe levels of impairment. Methylphenidate is the first-line drug. Psychological interventions without medication may be effective for some adults with moderate impairment, but there are insufficient data to support this recommendation. If methylphenidate is ineffective or unacceptable, atomoxetine or dexamfetamine can be tried. If there is residual impairment despite some benefit from drug treatment, or there is no response to drug treatment, CBT may be considered. Following titration and dose stabilisation, prescribing and monitoring should be carried out under locally agreed shared care arrangements with primary care (1). Give a brief outline of the drug and disease state, along with the rationale for shared care (i.e. what are the benefits of sharing care for this drug?) Drug Treatment Drug, dose, route of administration etc Adults Atomoxetine should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance daily dose is 80mg to 100mg. The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated. Shared Care Guideline February 2014 4 Other treatments Methylphenidate is the first-line drug. Psychological interventions without medication may be effective for some adults with moderate impairment, but there are insufficient data to support this recommendation. If methylphenidate is ineffective or unacceptable, atomoxetine or dexamfetamine can be tried. If there is residual impairment despite some benefit from drug treatment, or there is no response to drug treatment, CBT may be considered. In cases of potential substance misuse and diversion Atomoxetine is first line or Methylphenidate XL preparations could be considered 2 INDICATIONS Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and atomoxetine should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life. 3 PREPARATION STRATTERA* 10mg, 18mg, 25mg, 40mg, 60mg, 80 mg or 100 mg hard capsules 4 SAFETY ISSUES Please see the current BNF and SPC 4.1 Dose For oral use. Atomoxetine can be administered as a single daily dose in the morning, with or without food. Patients who do not achieve a satisfactory clinical response (tolerability [e.g. nausea or somnolence] or efficacy) when taking Atomoxetine as a single daily dose might benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening. Shared Care Guideline February 2014 5 4.2 Contra-indications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs). Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with a MAOI. Treatment with a MAOI should not be initiated within 2 weeks after discontinuing atomoxetine. Atomoxetine should not be used in patients with narrow-angle glaucoma, as in clinical trials the use of atomoxetine was associated with an increased incidence of mydriasis. Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders. Severe cardiovascular disorders may include severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels). Severe cerebrovascular disorders may include cerebral aneurysm or stroke. Atomoxetine should not be used in patients with pheochromocytoma or a history of pheochromocytoma. Shared Care Guideline February 2014 6 4.3 Cautions Suicide-related behaviour: Suicide-related behaviour (suicide attempts and suicidal ideation) has been reported in patients treated with atomoxetine.. Patients who are being treated for ADHD should be carefully monitored for the appearance or worsening of suicide related behaviour. Sudden death and pre-existing cardiac abnormalities: Sudden death has been reported in patients with structural cardiac abnormalities who were taking atomoxetine at usual doses. Although some serious structural cardiac abnormalities alone carry an increased risk of sudden death, atomoxetine should only be used with caution in patients with known serious structural cardiac abnormalities and in consultation with a cardiac specialist. Cardiovascular effects: Atomoxetine can affect heart rate and blood pressure. Most patients taking atomoxetine experience a modest increase in heart rate (mean <10 bpm) and/or increase in blood pressure (mean <5 mm Hg). Long-term sustained changes in blood pressure may potentially contribute to clinical consequences such as myocardial hypertrophy. As a result of these findings, patients who are being considered for treatment with atomoxetine should have a careful history and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease. It is recommended that heart rate and blood pressure be measured and recorded before treatment is started and, during treatment, after each adjustment of dose and then at least every 3 months to detect possible clinically important increases.. For adults, current reference guidelines for hypertension should be followed. Patients who develop symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt specialist cardiac evaluation. In addition, atomoxetine should be used with