SHARED PRESCRIBING GUIDELINE
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1 working in partnership with Kingston Richmond Wandsworth SHARED PRESCRIBING GUIDELINE Sutton & Merton Methylphenidate, Dexamfetamine and Atomoxetine for Attention Deficit Hyperactivity Disorder in patients under 18 years of age N.B. The eligibility criteria included here apply to new patients commencing treatment under this guideline & not to existing patients whose treatment was initiated under the previous version. However, monitoring and discontinuation criteria apply to all patients. NOTES to the GP The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing these drugs. The questions below will help you confirm this: Is the patient s condition predictable? (Noting the progressive nature of Alzheimer s Disease) Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care prescribing guideline? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for you to accept prescribing responsibility. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant within 14 days, outlining your reasons for NOT prescribing. If you do not have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, who will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to decline. Your PCT pharmacist will assist you in making decisions about shared care. It would not normally be expected that a GP would decline to share prescribing on the basis of cost. The patient s best interests are always paramount Date first approved: February 2004 Approved on behalf of SWL PCTs by: South West London Mental Health Interface Prescribing Forum (membership details available from John Woolven, Chief Pharmacist, SWLStG) Prepared by: Dr Morris Zwi (CAMHS Consultant) for: South West London & St Georges MH Trust Drug and Therapeutics Committee South West London Mental Health Interface Prescribing Forum (incorporating the MH Trust and NHS Kingston, NHS Sutton & Merton, NHS Richmond and NHS Wandsworth) This box can be used to confirm that shared care has been agreed between the consultant and GP. Patient name: Patient ID / D.O.B: Drug Name: Consultant Name: Consultant Signature: Indication: GP Name: GP Signature: 1
2 Methylphenidate, Dexamfetamine and Atomoxetine in under 18s 1. CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient s condition is stable or predictable and in accordance with NICE guidance. The patients will only be referred back to the GP once the GP has agreed in each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below The hospital will provide the patient with a minimum initial supply of 4 weeks of medication 2. AREAS OF RESPONSIBILITY Consultant 1. To assess the patient and establish a diagnosis of attention-deficit hyperactivity disorder; to determine a management strategy and communicate this to the family & GP. The diagnosis must clearly be demonstrated through a detailed report outlining the current problems, developmental history and presence of core signs of ADHD. These must meet the diagnostic criteria of the DSM-IV or the ICD-10 (hyperkinetic disorder). 2. Consider and discuss ADHD drug treatment options with the parents / responsible adult for the children who meet the criteria laid-down in NICE guidelines of September This should include a discussion of the reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and adverse effects. 3. Ensure relevant baseline investigations are performed, documenting height, weight and blood pressure and pulse. 4. Initiate treatment with methylphenidate, dexamfetamine or atomoxetine and prescribe medication until the dose has been stabilised. During this time monitor the patient as required for symptom control and side effects. 5. Provide the GP with appropriate clinical information and individual patient information. This may need to be more comprehensive with atomoxetine as GPs have much less experience and familiarity with this medicine. 6. Be available to give advice to GP if the patient s condition changes and to ensure that procedures are in place for prompt specialist review. 7. Perform a review of the patient, including a review of the need for medication, at least annually on an ongoing basis. 8. Advise the GP when the treatment is being discontinued to assess the need for ongoing treatment and provide supervision and assessment of the child during these periods. GP 1. Review the patient in accordance with specialist advice. 2. Prescribe methylphenidate, dexamfetamine or atomoxetine once the treatment has been established, the patient stabilised on a particular dose of medication and the care of patient has been transferred and accepted. 3. Monitor height, weight and blood pressure and pulse six monthly. Send copies of the results to the specialist. Notify the specialist of any concerns. 4. Re-refer the patient or seek specialist advice from the psychiatrist or paediatrician if there is deterioration in ADHD symptomatology, behaviour, or adverse effects of medication. 5. Although misuse of methylphenidate and dexamfetamine is rare, the GP should alert the Specialist to previous misuse of drugs by the young person or family members if such information is known. This is particularly important because methylphenidate and dexamfetamine are controlled drugs. 6. To report any adverse drug reactions to the Medicines and Healthcare Products Regulatory Authority (MHRA) as part of the yellow card scheme. Continued below 2
3 Consultant 9. Liaise with the patient s school and suggest appropriate extra educational provision where necessary. 10. Where the drug is to be continued beyond the age of 18, the consultant will advise about the options for ongoing care within adult services for each patient s particular needs. GP 2. COMMUNICATION AND SUPPORT Hospital contacts: (the referral letter will indicate named consultant) Tel: Fax: Enter the contact details of your local Child & Adolescent Mental Health Service (CAMHS) Team Out of hours contacts & procedures: Specialist support/resources available to GP including patient information: The on-call psychiatrist at your local hospital can be contacted via the hospital switchboard: Springfield Sutton Tolworth Queen Mary s Roehampton Contact with Child Psychiatrist 2. References (see key references at the end of this document) 3. Information in the British National Formulary for Children (BNFc) 4. ADHD support groups e.g. or (both of whom receive sponsorship from the pharmaceutical industry) CLINICAL INFORMATION Indication(s) Place in therapy Therapeutic summary Attention-deficit hyperactivity disorder (which is broadly similar to hyperkinetic disorder) is defined by core signs of an excess of inattention, hyperactivity and impulsiveness. These are normal personality traits, so is important to establish that they are present to a greater extent than expected in children of a developmental stage, that they cause impairment (commonly in social or academic domains) and that they are pervasive across a range of situations. Affected children often have co-morbid conditions including conduct disorder, oppositional defiant disorder, depression, anxiety, tic disorders and other developmental disorders. Methylphenidate, dexamfetamine and atomoxetine are recommended in the September 2008 NICE Guidelines on ADHD as part of a comprehensive treatment program for attention-deficit hyperactivity disorder in children and adolescents. (See Atomoxetine is still currently mainly used as a second or third line option where significant adverse effects occur with stimulant treatment e.g. intolerable appetite suppression or emotional lability. Methylphenidate, dexamfetamine and atomoxetine reduce the ADHD core symptoms : excessive inattention, hyperactivity and impulsivity. Duration of treatment o Determined on an individual basis o Transition to adult psychiatric services to be managed on an individual case basis as currently the numbers are very few, but increasing. o Advice to Adult Psychiatrists is available from Child & Adolescent psychiatrists. 3
4 Dose and Route of Administration All preparations are for oral administration. Dosage and timing will depend upon the patient and the form of the medicine: Methylphenidate Standard / Immediate release preparations Ritalin 10mg tablets; Equasym 5mg, 10mg, 20mg tablets o Initiate at 5mg OD or BD; increase dosage if necessary weekly, by increments of 5-10mg per day o Usual maximum dosage 60mg per day Modified release preparations Concerta-XL 18mg, 27mg, 36mg MR tablets o Initiate at 18mg daily; increase dose gradually according to needs and response of the patient. o Usual maximum 54mg per da,y but may be increased to 2.1 mg/kg daily (max. 108 mg daily) by specialists Equasym XL 10mg, 20mg, 30mg MR capsules o Initiate at 10 mg once daily in the morning before breakfast, increased gradually if necessary o Usual maximum 60 mg daily, but may be increased to 2.1 mg/kg daily (max. 90 mg daily) by specialists Medikinet XL 10mg, 20mg, 30mg, 40mg MR tablets o Initiate at 10 mg once daily in the morning before breakfast, increased gradually if necessary o Usual maximum 60 mg daily, but may be increased to 2.1 mg/kg daily (max. 90 mg daily) by specialists Dosage equivalence (immediate release (IR) vs. modified release (MR)): 5mg TDS (IR) = 18mg OD Concerta XL 10mg TDS (IR) = 36mg OD Concerta XL 15mg TDS (IR) = 54mg OD Concerta XL 5mg BD (IR) = 10mg Equasym XL 10mg BD (IR) = 20mg Equasym XL 15mg BD (IR) = 30mg Equasym XL Dexamfetamine Dexedrine 5mg tablets (standard release) o Initiate at 2.5 mg daily for children aged 3 5 yrs and 5 10 mg daily for children over 6yrs. o Increase dose to a usual maximum of 20 mg per day as necessary. o May require 40 mg or more daily in older children / adolescents. Atomoxetine Strattera 10mg, 18mg, 25mg, 40mg, 60mg, 80mg capsules o o patients up to 70 kg body weight: initiate at a total daily dose of approximately 0.5mg/kg. Increase the dose gradually as required to recommended maintenance dose of approx. 1.2mg/kg/day. patients over 70 kg body weight: initiate at a total daily dose of 40mg. Increase the dose gradually as required to recommended maintenance dose of 80mg. The maximum recommended total daily dose is 100mg. 4
5 Summary of adverse effects (See Summary of Product Characteristics for full list) Very common: >1/10 Common: >1/100, <1/10 Uncommon: >1/1000, <1/100 Rare: >1/10,000, <1/1000 Very rare: <1/10,000 Very common: >1/10 Common: >1/100, <1/10 Uncommon: >1/1000, <1/100 Rare: >1/10,000, <1/1000 Very rare: <1/10,000 Adverse effect Frequency Management Modestly raised resting pulse and blood pressure Weight loss / reduced weight gain Neurological effects incl. tics, depression, emotional lability, dizziness, anxiety, nervousness, hostility, headaches Common Monitor BP at baseline, every 6 months thereafter and at every dose change. Use with caution in patients with underlying medical condition (especially cardiovascular) Common Monitor height & weight at baseline & annually. Refer to consultant for discontinuation or interruption of treatment if signs of weight loss / growth suppression Common Discuss with consultant and agree appropriate action Insomnia / somnolence Common Discuss sleep hygiene; discuss with consultant possible trial of a small bedtime dose of stimulant Convulsions Rare Discontinue and discuss with consultant Neuroleptic Malignant Rare Stop and urgently refer to A&E Syndrome Blood Disorders Very Rare Differential blood & platelet counts if patient has recurrent nose bleeds, bruising or infections. If abnormal discontinue & discuss with consultant Abnormal liver function Very Rare Measure LFTs if there are clinical signs of abnormal liver function. Discontinue & discuss with consultant Sudden Death Very Rare See below and references: Prevention: A complete history should be taken documenting family history of sudden cardiac death, unexplained death or arrhythmias prior to initiation of stimulant treatment Physical examination for the presence of heart disease must be undertaken prior to initiation of treatment. Specialist cardiac evaluation, including ECG, should be sought where a significant cardiac history or abnormal examination is found. Caution should be used when treating patients whose underlying medical conditions might be compromised by increased blood pressure or heart rate. Monitoring Requirements: o Blood pressure & pulse every 6 months o Height & weight annually or sooner if clinically indicated o No routine measurement of LFTs / FBC, but measure if clinically indicated 5
6 Clinically relevant drug interactions: (See Summary of Product Characteristics (SmPC) for full list) In practice, very few children are taking other regular medicines. o Stimulant drugs may exacerbate effects of sympathomimetic drugs and coumarins, inhibit the metabolism of SSRIs and tricyclics, increase plasma concentration of anticonvulsants and increase risk of hypertension when volatile liquid anaesthetic gases are used. o Atomoxetine should not be used with MAOIs; caution if used with medicines that may decrease seizure threshold, increase QT interval or inhibit CYP2D6 (e.g. fluoxetine, paroxetine, quinidine, terbinafine) Practical issues: Prescriptions for methylphenidate and dexamfetamine must comply with all the requirements for prescribing of Controlled Drugs Stimulant medicines can be abused. As such, the prescriber must bear in mind any factors relating to the child or other family members that may be of concern in this regard The Concerta XL tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet Key references: NICE Guideline no. 72 September ments ). o British National Formulary for Children (accessed 10 November 2009) o Drug and Safety Update, Medicines and Healthcare Regulatory Agency website (accessed 10 November 2009) ate/con o Am J Psychiatry 166:9, September 2009 Editorial: Stimulant Treatment of ADHD and Risk of Sudden Death in Children o Gould MS et al Am J Psychiatry 2009; 166: Sudden Death and use of Stimulant Medications in Youths 6
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