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WORKING IN PARTNERSHIP WITH SHARED CARE GUIDELINE FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN AND YOUNG PEOPLE 1 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Document Reference No. Status Version Number Replacing/Superseded policy documents Number of Pages Target audience/applicable to Author MMSCG001 Final 2.0 or Acknowledgements Version 1.0 October 2013 3 West Kent GPs and Specialist Paediatricians from the partnership organisations Nirusha Govender, Lead Pharmacist for Children and Young People, KCHFT Sameena Shakoor, Consultant Paediatrician, KCHFT Janice Moorekite, Prescribing Advisor, West Kent CCG Dr Sanaa SAEED, Consultant Child and Adolescent Psychiatrist, Sussex Partnership NHS Foundation Trust Graham Brown, Lead Children’s & Younger Peoples Mental Health Pharmacist, Western Sussex Hospitals NHS Foundation Trust With acknowledgement and thanks to: Cambridgeshire and Peterborough Clinical Commissioning Group, Lancashire Medicines Management Group and Cornwall NHS Partnership Foundation Trust whose documents were used as a basis for this guidance. Contact Point for Queries Date Ratified Date of Implementation/distribution Circulation Review date Copyright Dr Sanaa SAEED, Consultant Child and Adolescent Psychiatrist, Sussex Partnership NHS Foundation Trust (on behalf of CAMHS for West Kent CCG) April 2016 April 2016 Policy Leads, partnership organisations staff intranet April 2018 West Kent Clinical Commissioning Group in Partnership with Kent Community Health NHS Foundation Trust (KCHFT) and Sussex Partnership NHS Foundation Trust Governance Arrangements Authorised/Ratified On West Kent Clinical Commissioning Group, Medicines Optimisation Group (MOG) Kent Community Health NHS Foundation Trust, Medicines Management Governance Group (MMGG) Drug and Therapeutics Group, Sussex Partnership NHS Foundation Trust West Kent GPs and Specialists from the partnership organisations West Kent Clinical Commissioning Group, Medicines Optimisation Group (MOG) Kent Community Health NHS Foundation Trust, Medicines Management Governance Group (MMGG) Drug and Therapeutics Group, Sussex Partnership NHS Foundation Trust April 2016 Review Date 2 years from ratification Review criteria This document will be reviewed prior to review date if a legislative change or other event dictates. Directorate or Function Governance Group responsible for developing document Circulation group Authorised/Ratified by Governance or Function Group Key References 1. 2. 3. 4. 5. NICE Clinical Guideline 72, Attention deficit hyperactivity disorder: Diagnosis and Management of ADHD in children, young people and adults. September 2008 NICE Quality Standard 39, Attention deficit hyperactivity disorder. July 2013 Access to www.medicines.org.uk/emc for individual drug SPCs for Methylphenidate, Dexamfetamine, Lisdexamfetamine and Atomoxetine. Accessed December 2015 NICE Clinical Guideline 158, Antisocial behavior and conduct disorders in children and young people: recognition and management. March 2013 NICE technology appraisal 98, Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) in children and adolescents. March 2006 2 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Executive Summary Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged from 6 years up to but not including 18 years of age. This shared care guideline relates to patients with ADHD whose condition is stable at hand over from the ADHD Specialist (Paediatrics/CAMHS) to primary care. This shared care guideline is in accordance with NICE clinical guideline 72 and NICE Quality Standard 39. The GP is expected to: Prescribe the recommended medication after initiation and stabilisation by the specialist (also, in exceptional clinical circumstances prescribing may be requested during a titration; the GP should do so on these occasions providing clear guidance has been given by the Specialist). Monitor height, weight, blood pressure, pulse and auscultation (heart rate and regularity) at six months in between the annual specialist reviews. Email these findings to the Specialist for action. Act in accordance with the advice in this guideline if side effects are identified. The Specialist is expected to: Undertake an assessment and identify people suitable for medication. Initiate prescribing and request for transfer to shared care when stable. Assess for efficacy and adverse effects at the start of treatment and then at least yearly, monitoring height, weight, auscultation (heart rate and regularity), pulse and blood pressure at annual reviews. Respond to auscultation (heart rate and regularity), blood pressure, height and weights sent in by GPs with advice about continuing (or not) with the ADHD medication. Offer an annual break in patients who are prescribed stimulant medication. If a treatment break is refused by patient/carer/family the rationale should be documented in the notes (in accordance with MHRA guidance and product SPCs) Arrange transfer of care for young people over the age of 17. The Parent/Carer is expected to: Follow the Specialist advice by booking an appointment for their child’s auscultation (heart rate and regularity), blood pressure, pulse, weight and height to be measured, attending these and specialist appointments. Let the Specialist know if there are any concerns. Store the tablets safely and securely out of the reach of children and young people. This shared care guideline excludes: Treatment of children under 6 years Treatment of adults aged 18 years and over Sharing of care depends on communication between the Specialist, GP and the patient or their parent/carer. The intention to share care should be explained to the patient and accepted by them. Patients are under regular follow-up and this provides an opportunity to discuss drug therapy. The Doctor/Healthcare Professional who prescribes the medication has the clinical responsibility for the drug and the consequences of its use. 3 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Scope Children and young people (from 6 -18 years old) with a diagnosis of ADHD. Aim To clarify the responsibilities and roles of the Specialist and GPs in the management of drug treatment in children and young people with ADHD. Introduction NICE Clinical Guideline ADHD: Diagnosis and management of ADHD in Children and Young People and Adults (March 2013) indicates that ongoing prescribing of medication may take place in primary care. NICE guidance states: For a diagnosis of ADHD, symptoms of hyperactivity/impulsivity and/or inattention should: • meet the diagnostic criteria in DSM-IV or ICD-10 (hyperkinetic disorder) and • be associated with at least moderate psychological, social and/or educational or occupational impairment based on interview and/or direct observation in multiple settings, and • be pervasive, occurring in two or more important settings including social, familial, educational and/or occupational settings. As part of the diagnostic process, include an assessment of the person's needs, coexisting conditions, social, familial and educational or occupational circumstances and physical health. For children and young people, there should also be an assessment of their parents' or carers' mental health. Healthcare professionals should offer parents or carers of pre-school children with ADHD a referral to a parent-training/education programme as the first-line treatment if the parents or carers have not already attended such a programme or if the programme they attended has had a limited effect. Teachers who have received training about ADHD and its management should provide advice on behavioural support in the classroom. If the child or young person with ADHD has moderate levels of impairment, the parents or carers should be offered referral to a group parent-training/education programme, either on its own or together with a group treatment programme (cognitive behavioural therapy [CBT] and/or social skills training) for the child or young person. In school-age children and young people with severe ADHD, drug treatment should be offered as the first-line treatment. In that instance, parents should also be offered a group-based parenttraining/education programme. Drug treatment for children and young people with ADHD should always form part of a comprehensive treatment plan that includes psychological, behavioural and educational advice and interventions. When a decision has been made to treat children or young people with ADHD with drugs, healthcare professionals should consider: • Methylphenidate for ADHD without significant comorbidity • Methylphenidate for ADHD with comorbid conduct disorder • Methylphenidate or atomoxetine when tics, Tourette's syndrome, anxiety disorder, stimulant misuse or risk of stimulant diversion are present • Atomoxetine if methylphenidate has been tried and has been ineffective at the • Maximum tolerated dose or the child or young person is intolerant to low or moderate doses of methylphenidate. • Lisdexamfetamine is licensed for use as a second line agent to methylphenidate. This should preferably be done after the use of at least two modified release preparations of methylphenidate unless a previous adverse reaction to methylphenidate or unacceptable side effect has ruled out further use. If there is a choice of more than one appropriate drug, the product with the lowest cost (taking into account the cost per dose and number of daily doses see Appendix 5) should be prescribed. Antipsychotics are not recommended for the treatment of ADHD in children and young people. When starting drug treatment children and young people should be monitored for side effects. In particular, those treated with atomoxetine should be closely observed for agitation, irritability, suicidal thinking and self-harming behaviour, and unusual changes in behaviour, particularly during the initial months of treatment, or after a change in dose. Parents and/or carers should be warned about the potential for suicidal thinking and self-harming behaviour with atomoxetine and asked to report these to their healthcare professionals. Parents or carers should also be warned about the potential for liver damage in rare cases with atomoxetine (usually presenting as abdominal pain, unexplained nausea, malaise, darkening of the urine or jaundice). Dexamfetamine should be considered in children and young people whose ADHD is unresponsive to a maximum tolerated dose of methylphenidate, atomoxetine or lisdexamfetamine. In children and young people whose ADHD is unresponsive to methylphenidate and atomoxetine then consideration for the use of lisdexamfetamine or dexamfetamine is appropriate. Further treatment may include the use of medication unlicensed for the treatment of ADHD (such as bupropion, clonidine, modafinil and imipramine) or combination treatments (including psychological treatments for the parent or carer and the child or young person). The use of medication unlicensed for ADHD should only be considered in the context of tertiary services. 4 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Medication Where drug treatment is considered appropriate, methylphenidate, atomoxetine and dexamfetamine are recommended, within their licensed indications, as options for the management of ADHD in children and adolescents. (Lisdexamfetamine is included in this guideline as an alternative medication to dexamfetamine which has been made available since the publication of the NICE guidance). Methylphenidate, lisdexamfetamine and dexamfetamine are all Schedule 2 Controlled Drugs. Controlled drug prescription requirements should be followed. The decision regarding which product to use should be based on the following: • the presence of comorbid conditions (for example, tic disorders, Tourette's syndrome, epilepsy) • the different adverse effects of the drugs • specific issues regarding compliance identified for the individual child or adolescent, for example problems created by the need to administer a mid-day treatment dose at school • the potential for drug diversion (where the medication is forwarded on to others for nonprescription uses) and/or misuse • the preferences of the child/adolescent and/or his or her parent or guardian. When prescribing methylphenidate for the treatment of children or young people, modified-release preparations should be considered for the following reasons: • convenience • improving adherence • reducing stigma (because the child or young person does not need to take medication at school) • reducing problems schools have in storing and administering controlled drugs • their pharmacokinetic profiles. Alternatively, immediate-release preparations may be considered if more flexible dosing regimens are required, or during initial titration to determine correct dosing levels. Diagnosis and initiation of treatment must be made by a Specialist in the treatment of ADHD Stimulants used to treat ADHD work by increasing dopamine levels in the brain to improve focus and functioning If there is a choice of more than one appropriate drug, the product with the lowest cost (taking into account the cost per dose and number of daily doses see Appendix 5) should be prescribed. Following titration and dose stabilisation, prescribing and monitoring should be carried out under locally agreed shared care arrangements with primary care. Newly licensed medicines for ADHD that are currently not included in this guideline will be considered for inclusion by the partnership governance mechanisms when they become available. 5 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Drug Methylphenidate Form and Cost included per pack size of 30/28 where applicable Atomoxetine Tablets 5mg(£3.03), 10mg(£5.49), 20mg(£10.92) (Medikinet®, Ritalin®, Tranquilyn®) (Strattera®) Capsules 10mg(£62.46), 18mg(£62.46), 25mg(£62.46), 40mg(£62.46), 60mg(62.46), 80mg(£83.28), 100mg(£83.28) *Note Ritalin-SR® 20mg tablets is imported from the USA and is a special item (cost will be significantly higher and vary within the pharmacy supply chain in the UK). Oral Solution 4mg/ml (300ml = £100.00) Tablets M/R 18mg(£31.19), 27mg(£36.81), 36mg (£42.45), 54mg(£60.48) (Xenidate® XL, Matoride® XL, Concerta® XL) Dexamfetamine Tablets 5mg(£19.89/£24.75) (Amfexa®) *Note Dexedrine® Spansule (MR Capsule) 5mg, 10mg, 15mg is imported from the USA and is a special item (cost will be significantly higher and vary within the pharmacy supply chain in the UK). Oral Solution 5mg/5ml (150ml = £34.35 and 500ml = £114.49) Lisdexamfetamine Hard capsules 30mg(£58.24), 50mg(£68.60), 70mg(£83.16) (Elvanse®) *Note Vyvanse® Capsules 20mg, 30mg, 40mg, 50mg, 60mg, 70mg is imported from the USA and is a special item (cost will be significantly higher and vary within the pharmacy supply chain in the UK). Guanfacine Prolonged-release tablets 1mg(£56.00), 2mg(£58.52), 3mg(£65.52),4mg(£76.16) (Intuniv®) *Note Intuniv® PR Tablets 1mg, 2mg, 3mg, 4mg has recently been launched in the UK (January 2016) and has been issued status as it is subject to additional monitoring by the MHRA which will allow quick identification of new safety information. Healthcare professionals are asked to report any/ALL suspected adverse reactions via the Yellow Card system. Capsules M/R 10mg(£25.00), 20mg(£30.00), 30mg(£35.00) (Equasym XL®) Capsules M/R 5mg(£24.04), 10mg(£25.00), 20mg(£30.00), 30mg(£35.00), 40mg(£57.72), 50mg(£62.52), 60mg(£67.32) (Medikinet XL®) Modified Release preparations are not interchangeable. Prescribe by brand. 6 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Dose (For full details see NICE CG72, the individual SPCs and the BNFC) Child aged 6-18 years: Short acting < 6 years – unlicensed > 6 years – up to 60 mg daily in divided doses Long acting Concerta® XL /Matoride® XL < 6 years – unlicensed > 6 years up to 54 mg once daily (some guidelines, e.g., the Canadian ones (http://www.caddr a.ca/practiceguidelines/downlo ad ) recommend up to 72 mg/day in children < 40 kg and up to 90 mg/day in adolescents Equasym® XL < 6 years – unlicensed >6 years up to 60 mg once daily Medikinet® XL < 6 years – unlicensed > 6 years up to 60 mg once daily Child over 6 years bodyweight under 70kg: Initially 500micrograms/kg daily for 7 days, increased according to response. Usual maintenance 1.2mg/kg daily but may be increased to 1.8mg/kg daily (max. 120mg daily) under the direction of a specialist. Child/Adolescent body-weight over 70kg: Initially 40mg for 7 days, increased according to response. Usual maintenance 80mg daily but may be increased to a maximum recommended total daily dose of 120mg under the direction of a specialist. Child aged 6-18 years: Initially 2.5mg 2-3 times daily, increased if necessary at weekly intervals by 5mg daily Child over 6 years: 30mg once daily in the morning, increasing by 20mg daily increments at weekly intervals to a maximum of 70mg Usual max. 1mg/kg (up to 20mg) daily (40mg daily has been required in some children). Maintenance dose given in 2-4 divided doses. There is no proprietary product. Doses above 100mg daily are not licensed but are stated in the BNFc. Intuniv® is indicated for the treatment of ADHD in children and adolescents 6-27years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective Intuniv® must be used as part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders. It is recommended that all patients, either starting treatment for ADHD or switching from another medication begin treatment on a dose of 1mg/day. The dose may be adjusted in increments of not more than 1mg/week. The usual maximum dose is 4mg in children and 4-7mg in adolescents depending on weight. Dose should be individualised according to the patient's response and tolerability. Depending on the patient's response and tolerability for Intuniv® the recommended maintenance dose range is 0.05-0.12 mg/kg/day. See table available in the product SPC. Missed dose: Discontinue if no response after one month In the event of a missed dose, Intuniv® dosing can resume the next day. If two or more consecutive doses are missed, re-titration is recommended based on the patient's tolerability to guanfacine. Evening dose: It effect wears off (with rebound hyperactivity) a dose at bedtime may be appropriate (establish need with trial bedtime dose) When prescribing 7 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH methylphenidate for the treatment of children or young people, modified-release preparations should be considered for the following reasons: Convenience improving adherence reducing stigma (because the child or young person does not need to take medication at school) reducing problems schools have in storing and administering controlled drugs their pharmacokinetic profiles. Alternatively, immediaterelease preparations may be considered if more flexible dosing regimens are required, or during initial titration to determine correct dosing levels. Note –Dosing schedules for the individual preparations should be consulted. Refer to SPCs or BNFc for dosing schedules. 8 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Administration Common Adverse Effects (please refer to the latest SPC or BNFc for full list) Potentially Serious Drug Interactions (please refer to the latest SPC or BNFc for full list) Contents of Equasym XL® capsules and Medikinet XL® capsules, can be sprinkled on a tablespoon of apple sauce, and then swallowed immediately without chewing. Drinking some fluids, e.g. water should follow the intake of sprinkles with apple sauce. Concerta XL® - tablet membrane can pass through the GI tract unchanged. Dose form not appropriate for dysphagia or if GI lumen is restricted. Concerta XL® must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Decreased appetite, weight loss, growth retardation, insomnia, mood changes, headaches, dizziness, drowsiness, tachycardia, increased blood pressure, cough, gastrointestinal side-effects, rashes delusions, hallucinations, anxiety, panic, stimulant related tics, sexual dysfunction. Adrenergic neurone blockers: antagonism of hypotensive effect Coumarins: possible increased anticoagulant effect MAOIs and Moclobemide: risk hypertensive crisis SSRIs and tricyclic antidepressants: Methylphenidate may inhibit metabolism of the antidepressants Total daily dose may be given either as a single dose in the morning or in 2 divided doses with the last dose no later than early evening. Tablets can be halved. Take with or without food. Swallow whole or opened and dispersed in a glass of water (take immediately) Intuniv® is a prolonged-release formulation to be taken orally in the morning or evening. The tablet should be swallowed whole, and should not be administered with high fat meals, to avoid increasing guanfacine exposure. Halve the dose in moderate hepatic impairment, quarter the dose in severe hepatic impairment. Atomoxetine oral solution should only be prescribed when patients are unable to take tablets. Emergence of suicidal behaviour, self-harm or hostility, serious liver damage; decreased appetite, weight loss, insomnia, irritability, headache, drowsiness, dizziness, gastrointestinal side-effects, lethargy, increased heart rate and blood pressure, dysmenorrhea, sexual dysfunction, rashes. Decreased appetite, weight loss, growth retardation, insomnia, mood changes, headaches, dizziness, drowsiness, tachycardia, increased blood pressure, cough, gastrointestinal side-effects, rashes delusions, hallucinations, anxiety, panic, stimulant related tics, sexual dysfunction. Sleep difficulties, headache, reduced appetite, upper abdominal pain, reduced weight gain or weight loss, reduced appetite, Tics Somnolence, headache, fatigue, abdominal pain upper, vomiting, diarrhea, nausea, constipation, dry mouth sedation, weight gain, depression, anxiety, insomnia, nightmare, sedation, dizziness, lethargy, bradycardia, hypotension and syncope. Methadone, amiodarone, disopyramide, moxifloxacin, parenteral erythromycin, mefloquine, antipsychotics which prolong QTc interval, sotalol, and hypokalaemias secondary to diuretics: increased risk of ventricular arrhythmias. Antidepressants: increased risk of seizures. Additionally: SSRIs: Potential for increased atomoxetine levels with paroxetine and fluoxetine. Guanethidine: antagonism of hypotensive effect MAOI and Moclobemide: risk of hypertensive crisis MAOIs: risk of hypertensive crisis Chlorpromazine, haloperidol: effects of lisdexamfetamine possibly reduced When Intuniv® is used concomitantly with CYP3A4/5 inhibitors and inducers, plasma concentrations of guanfacine may be elevated or lowered, potentially affecting the efficacy and safety of Intuniv®. Intuniv® can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4/5. The pharmacodynamic effect of Intuniv® can have an additive effect when taken with other products known to cause sedation, hypotension or QT prolongation. 9 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Contraindications (please refer to the latest SPC or BNFc for full list) Severe depression, suicidal ideation, anorexia nervosa, psychosis, uncontrolled bipolar disorder, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorders, hyperthyroidism or thyrotoxicosis, cardiovascular disease, structural cardiac abnormalities, phaeochromocytoma, vasculitis, cerebrovascular disorders, glaucoma MAOIs: two week washout period required between and MAOI and Atomoxetine prescriptions. Tricyclics: increased risk of ventricular arrhythmias. Phaeochromocytoma, narrowangle glaucoma, severe cardiovascular or cerebrovascular disorders Cardiovascular disease including moderate to severe hypertension, structural cardiac abnormalities, advanced arteriosclerosis, hyper excitability or agitated states, hyperthyroidism, glaucoma, porphyria, history of drug or alcohol abuse, patients with Gilles de la Tourette syndrome or similar dystonias Hypersensitivity to the active substance or to any of the excipients listed in the SPC. Intuniv® can cause syncope, hypotension and bradycardia. Syncope may involve risk of falls or accidents, which could result in serious harm. Caution is advised when treating patients who have a history of hypotension, heart block, bradycardia or cardiovascular disease, or who have a history of syncope or a condition that may predispose them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration. Caution is also advised when treating patients with Intuniv® who are being treated concomitantly with antihypertensives or other medicinal products that can reduce blood pressure or heart rate or increase the risk of syncope. Patients should be advised to drink plenty of fluid. Caution in patients with a known history of QT prolongation and suicidal ideation. Children and adolescents treated with Intuniv® may show an increase in their BMI. Therefore, monitoring of height, weight and BMI should be done prior to initiation of therapy and then every 3 months for the first year, taking into consideration clinical judgement. 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustment. 10 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Monitoring Standards and Actions to take in the event of abnormal test results/symptoms MONITORING Methylphenidate, Dexamfetamine and Lisdexamfetamine, Guanfacine Parameter Frequency of monitoring Action By whom Weight 6monthly Failure to gain weight appropriately – reduce the dose or withdraw the medicine Specialist annual review GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate GP Full blood count (FBC) Blood pressure and pulse Auscultation (heart rate and regularity) Growth (weight and height) 6 monthly 6 monthly Have a low threshold for carrying out a FBC e.g. if recurrent infections or purpuric rash occur. There is no need for routine testing. Monitor whilst taking medication to ensure within published range e.g. for age of child – see Appendix 1. If raised repeat the measurement. The dose may need to be reduced, or arrangements may need to be made for 24hour blood pressure readings. The Specialist will be able to advise. Many children lose a small amount of weight (about a kg) at the beginning of treatment. Weight and height should be plotted on published Growth Charts – see appendix 1. If weight loss continues or if child’s weight trajectory crosses more than one centile line or if this translates into the height trajectory being similarly affected: Provide supporting information to help parents promote good diet – see Appendix 1. Reduce dose or encourage breaks from treatment at weekends/in school holidays. Withdraw treatment Specialist annual review GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate Specialist annual review GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate 11 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Atomoxetine, Guanfacine Parameter Frequency of monitoring Action By whom Gaunfacine *Special note Treatment initiation Specialist initially as per titration and annual review. GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate Appearance of suicidal behaviour, self-harm or hostility Ongoing basis at appointments Monitoring during titration During dose titration, weekly monitoring for signs and symptoms of somnolence and sedation, hypotension and bradycardia should be performed. Ongoing monitoring During the first year of treatment, the patient should be assessed at least every 3 months for: Signs and symptoms of: somnolence and sedation hypotension bradycardia weight increase /risk of obesity It is recommended clinical judgement be exercised during this period. 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustments Patients/parents should be advised of this risk and made aware of possible signs and symptoms to report back to the specialist immediately if noticed. Blood pressure and pulse Auscultation (heart rate and regularity) Growth (weight and height) 6 monthly Monitor whilst taking medication to ensure within published range e.g. for age of child – see appendix 1. 6 monthly Many children lose a small amount of weight (about a kg) at the beginning of treatment. Weight and height should be plotted on published Growth Charts – see appendix 1. If weight loss continues or if child’s weight trajectory crosses more than one centile line or if this translates into the height trajectory being similarly affected: Provide supporting information to help parents promote good diet – see Appendix 1. Reduce dose or encourage breaks from treatment at weekends/in school holidays. Withdraw treatment Specialist and GP Telephone the on-call practitioner/on-call CAMHS psychiatrist to communicate in emergency Specialist annual review GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate Specialist annual review GP at 6 months in between specialist reviews - Use proforma appendix 2A/2B, 3 or 4 to communicate as appropriate 12 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH ROLES and RESPONSIBILITIES Specialist Responsibilities 1. 2. 3. 4. 5. Confirmation of diagnosis and identification of suitable patients following full assessment. Request agreement of shared care with primary care prescriber. Initiation of licensed ADHD therapy: methylphenidate, dexamfetamine, lisdexamfetamine & atomoxetine. Discussion of risks and benefits with patients, outline possible side effects and explain their roles. To undertake a complete history, documenting: concomitant medicines; past and present medical and psychiatric disorders or symptoms; family history of sudden cardiac death, unexplained death, or malignant arrhythmia. 6. 7. To undertake a physical examination for the presence of heart disease. To assess baseline cardiovascular status, including blood pressure and auscultation (heart rate and regularity) before prescribing and get specialist cardiac advice if appropriate. Issuing initial prescription(s) until the patient is stabilised (minimum of one month) even if prescribing responsibility is transferred earlier than this. To ensure the patient/parent/carer are fully informed of the potential benefits and side effects of treatment and ensure the person with parental responsibility (and where appropriate, the young person) consents to the treatment. Share with the GP any information about consent that s/he needs to know. 8. 9. 10. To review the patient and monitor the following (if relevant to specific drug)at least 6 monthly act on the results appropriately and communicate these results to the primary care prescriber: Weight and appetite, recorded at baseline, following dosage adjustments and 6 monthly. Auscultation (heart rate and regularity), blood pressure and pulse, recorded at baseline, following dosage adjustments and at 6 monthly reviews (please note variation to this for guanfacine monitoring requirements for treatment initiation in the first year in the table above) Blood and platelet counts at discretion of supervising clinician(s) (e.g. if recurrent nose bleeds, bruising or infections occur). Baseline, then when clinically indicated. Liver function tests if prescribing atomoxetine if clinically indicated. To refer patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, 13dyspnoea, or other symptoms suggestive of heart disease for prompt specialist cardiac evaluation. The development of new or worsening of pre-existing, psychiatric symptoms (also following dose adjustments) and at every visit) and any comorbidity associated with ADHD. 11. When stimulant medication (methylphenidate, dexamfetamine or lisdexamfetamine) is being used, to look out for signs of diversion (transfer of the medicine from the individual for whom it was prescribed for, to one for whom it is not prescribed), misuse, and abuse. 12. If prescribing modified release methylphenidate this must be by ‘Brand’ to avoid the risk of the wrong formulation being dispensed. 13. Patients prescribed stimulant medication should be offered an annual treatment break to assess continued need for pharmacotherapy. 14. Ensure that all newly treated patients (and/or their carers) receive appropriate education and advice regarding their drug therapy, shared care arrangements and when to seek medical advice in order to maximize compliance. This should include written information where appropriate. 15. Providing primary care prescriber with clinic letter stating planned introduction and reviews and additional advice if appropriate. 16. Communicate promptly with the GP about any changes in treatment and respond promptly to any concerns raised by the GP. 17. Provide outpatient reviews, monitor effectiveness/side effects 18. Notify the GP of the patient’s failure to attend for clinical review or drug monitoring and give advice on stopping the medication. 19. To liaise and advise primary care prescriber to interrupt treatment at least annually to assess ongoing need. 20. To advise and support parents and teachers, liaising where appropriate with the child’s school. 21. To use feedback and questionnaires, ideally from the child`s school as well as home, to monitor response and facilitate the possible change of medication. 22. To take responsibility for stopping the drug and organizing medication breaks. 23. Ensure clear arrangements are in place for back up, advice and support e.g. out of hours and/or when the consultant initiating therapy is not available. 24. Evaluate any adverse effects reported by the GP (Any adverse effects which are suspected to relate to the drug should be reported via the Yellow Card System). 25. Refer for additional behavioural therapy (social skills, anger management or parents’ group/parenting skills) if and when appropriate. 26. Arrange transfer to adult services if medication is to continue over the age of 17. 13 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Primary Care Prescriber (GP) Responsibilities 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. Ensure that shared care arrangements are in place before taking over prescribing/monitoring and: That the patient/carer is clear what is being monitored and by whom. That the patient/carer knows what significant adverse effects/events to report urgently and to whom they should report (specialist or GP). Confirm that proposed therapy is not contra-indicated because of concurrent therapy for other conditions the patient may be suffering from e.g. check drug-drug and drug-disease interactions and refer to secondary care with a full history where appropriate. To provide repeat prescriptions of the licensed ADHD medications described above at the dose recommended once the patient is stabilised (not before initial one month stabilisation period). A demonstrable system should be in place to ensure that prescribing is reviewed by the primary care prescriber if there is no record of the fact that monitoring has taken place within the agreed time scales. Prescriptions for stimulants (methylphenidate, dexamfetamine or lisdexamfetamine) should be restricted to 30 days supply and are only valid for 28 days from the date of signature as stimulant medications are controlled drugs subject to safe custody and specific regulations for prescribing. Be aware of the potential of Atomoxetine to (rarely) precipitate suicidal behaviour, self-harm or hostility particularly where there is a history of depression or suicidal behaviour. Ask specialist for an early review if needed as a matter of urgency. To record any changes in therapy in the prescribing record on receipt of such communication from secondary care and to act upon these. To monitor prescribing rate of ADHD medications for individual patients. Monitor height, weight, blood pressure, pulse and auscultation (heart rate and regularity) annually six months after the annual specialist review or more frequently if there are specific concerns and at the request of the specialist. Check these against standard charts (see Appendix 1) or email the observations to the Specialist Paediatrician who will be able to provide guidance. If in doubt about effectiveness or side-effects, share this information with the specialist clinic. Seek advice from the Specialist Paediatrician if the patient does not attend for monitoring appointments. To contact consultant / specialist if deterioration in behavior. Check for possible drug interactions when newly prescribing or stopping concurrent medication. Report any suspected adverse drug reactions to the specialist who initiated therapy under the shared care agreement. Report adverse events via the yellow card scheme. To refer patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of heart disease for prompt specialist cardiac evaluation. Arrange appropriate investigations (FBC) if patients present with unexplained bruising; consider withdrawal of medication; seek paediatric/haematology advice and contact the specialist team. Arrange appropriate investigation if the patient shows signs of liver problems and discontinue the medication if the person has jaundice or has laboratory evidence of hepatic injury. Seek paediatric/gastro-enterology advice and contact the specialist team. To monitor patients overall health and well-being. Discuss potential benefits and side effects of treatment with the patient/carer to address any outstanding queries. Liaise with consultant / specialist if any cause for concern or drug discontinued. If requested, undertake an ECG for appropriate patients and send tracings to consultant/specialist for review. If prescribing modified release methylphenidate this must be by ‘Brand’ to avoid the risk of the wrong formulation being dispensed. When prescribing stimulant medication, to look out for signs of diversion (transfer of the medicine from the individual for whom it was prescribed to one for whom it is not prescribed), misuse, and abuse. If care of the patient is transferred to another prescriber that the new prescriber is made aware of this information. In appropriate patients to interrupt treatment at least annually after a discussion with the child`s parent and on the recommendation of the specialist. To ensure all relevant staff within the practice are aware of the shared care guidelines Monitor compliance through rates of prescription 14 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Patient’s / Carer’s role 1. 2. 3. 4. Ask the Specialist or GP for information, if he or she does not have a clear understanding of the treatment. Discuss Discuss potential benefits and side effects of treatmentwith with the the specialist any outstanding queries. potential benefits and side effects of treatment specialistand andGP, GP,raise raise any outstanding queries. Discuss potential benefits and side effects of treatment with the specialist and GP, raise any outstanding queries Share any concerns in relation to treatment with any medication covered by this agreement with the Specialist Paediatrician. Provide adequate feedback to relevant Healthcare Professional and ensure that the correct person from the child`s school provides such feedback to titrate medication effectively. Inform the Specialist or GP of any other medication being taken, including over-the- counter products. 5. Read the patient information leaflet included with your medication and report any side effects or concerns you have to the consultant / specialist or primary care prescriber. 6. Report any adverse effects to their Specialist whilst child/young person is taking drug(s) 7. Attend all appointments suggested in the time frame advised so that the therapy can be properly monitored. This includes booking appointments in primary care as suggested by the specialist. Be aware that if monitoring is not possible because appointments are not made and attended, it may not be possible for the medication to continue. 8. Arrange blood tests as per consultant / specialist request. 9. For children who need to take medication during the school day, ensure that school have a supply of tablets in its original packaging as supplied by the community pharmacy with a label stating clear instructions for administration of the medicine. 10. When supplying medicines to school please ensure you adhere and comply with the school’s medicine policy. 11. Please note that some of the medicines prescribed may be classified as controlled drugs and these drugs will have further special storage or safe custody requirements when sent to school – please ensure you are familiar with these requirements at your child’s school. 12. Store the tablets safely and securely out of the reach of children and young people keeping in mind that all medication is dangerous if taken in over-dose. 15 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 1: Resources Post-diagnostic advice After diagnosis people with ADHD and their parents or carers may benefit from advice about diet, behaviour and general care. General advice Following a diagnosis of ADHD, healthcare professionals should consider providing all parents/carers self-instruction manuals, and other materials such as DVDs, based on positive parenting and behavioural techniques. All patients should be offered psycho-educational advice and or workshops. Dietary advice Healthcare professionals should stress the value of a balanced diet, good nutrition and regular exercise. The elimination of artificial colouring and additives from the diet is not recommended as a generally applicable treatment. Clinical assessment of ADHD should include asking about foods or drinks that appear to influence their hyperactive behaviour. If there is a clear link, healthcare professionals should advise elimination of certain food/drinks from the diet. Dietary fatty acid supplementation is not recommended for the treatment of ADHD in children and young people. Growth (height and weight) Standard growth charts are available from http://www.rcpch.ac.uk/child-health/researchprojects/uk-who-growth-charts/uk-growth-chart-resources-2-18-years/uk-2-18-years Blood Pressure Blood pressure can be checked against population norms such as the NIH charts which allow readings to be checked against gender, age and height centile http://www.nhlbi.nih.gov/files/docs/guidelines/child_tbl.pdf Blood pressure, pulse, weight and height measurements may be emailed to the specialist clinic using the proforma in Appendix 3. Please indicate if you require a response from the specialist clinic. The contact details for sending these values to the clinics are: Contact numbers for advice and support Name / position Specialist / Consultant: West Kent Community Paediatricians Hospital Pharmacy: Out of hours: Team Location Duty Consultant (Maidstone CAMHS) Knightrider House, Knightrider Street, Maidstone, Kent, ME15 6LU Dr Sameena Shakoor, Kent Community Health NHS Consultant Paediatrician Foundation Trust and Clinical Lead The Homeopathic Hospital 41 Church Road Royal Tunbridge Wells Or Duty Paediatrician Kent TN1 1JU Maidstone Hospital Hermitage Ln, Maidstone, Kent, ME16 9QQ Tunbridge Wells Hospital (Pembury) Tonbridge Road, Pembury Tunbridge Wells Kent, TN2 4QJ On call physicians N/A Telephone Email 01622 356930 N/A 01892 539144 N/A 01622 224313 N/A 01892 633281 N/A N/A 16 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 2A: Specialist Paediatrician Review Letter for Primary Care Community Paediatrics – Homeopathic Hospital, Tunbridge Wells 17 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 2B: Specialist Paediatrician Review Letter for Primary Care Community Paediatrics – The Heathside Centre, Coxheath 18 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 3: Brief health check for ADHD patients in primary care Patient Name: Date of Birth: NHS number: The above patient was seen in primary care on: Blood pressure : Auscultation (heart rate and regularity): Pulse rate : Weight : Height: Any other comments: Please tick if you would like the Specialist to advise about continued treatment. (*Specialist to use Appendix 3 to provide the response) Signature: Name (in full) and designation: Name of GP practice: Thank you. Please email this record to the Specialist. 19 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 4: Advice to Primary Care from the Specialist Patient Name: Date of Birth: NHS number: Thank you for sending in the above patient’s physical measurements. Having seen this information and checked the patient’s record, I can advise the following: Advice: Date: Signature: Name(in full) of Healthcare Professional: Designation of Healthcare Professional: This advice is to be sent to the GP and copied to parents/carers. 20 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final WORKING IN PARTNERSHIP WITH Appendix 5: Cost Analysis of Licensed ADHD Medicines Medication Strength Methyphenidate instant release (including Ritalin®) Concerta® XL Matoride® XL Equasym® XL Medikinet® XL Guanfacine MR (Intuniv®) Atomoxetine (Strattera®) 5mg Cost / single dose unit (£) £0.10 Original pack cost;(Pack Size) £3.03 (30) 10mg £0.18 £5.49 (30) 18mg 27mg 36mg 45mg** £1.04 £1.23 £1.42 £2.27 (1x 18mg & 1x 27mg) £2.45 £0.83 £1.13 £2.02 £0.83 £1.00 £1.17 £2.34 (2 x 30mg) £0.80 £0.80 £0.96 £1.12 £1.93 £2.24 (2 x 30mg) £2.00 £2.09 £2.34 £2.72 £4.43 £4.68 £5.06 £2.23 (£4.46)*** £31.19 (30) £36.81 (30) £42.45 (30) £68.00 (30) 54mg 18mg 36mg 54mg 10mg 20mg 30mg 60mg 5mg 10mg 20mg 30mg 40mg 60mg 1mg 2mg 3mg 4mg 5mg (2mg & 3mg) 6mg (2 x 3mg) 7mg (3mg & 4mg) 10mg, 18mg,25mg, 40mg & 60mg 80mg & 100mg £895.71 £302.95 £412.45 £737.30 £314.17 £365.00 £425.83 £851.66 £292.49 £292.49 £351.13 £409.53 £702.63 £819.06 £730.00 £762.85 £854.10 £992.80 £1616.95 £1708.20 £1846.90 £813.95 (1627.90)*** £1084.05 (£1898.00)*** Lisdexamfetamine 30mg £759.20 (Elvanse®) 50mg £894.25 70mg £1084.05 Dexamfetamine 5mg 5mg OD is £321.20; 10mg BD is £1284.80 *Assumes drug used 365 days a year with no break at weekends or during school holidays. ** No single dose for this strength, hence made up of 2 doses combined. *** Based on one dose being prescribed. Dosing is based on body weight, so two doses are sometimes prescribed, this doubles the cost – indicated in brackets. Note: Costs correct as of www.ppa.org.uk/ppa/edt_intro.htm £2.97 (£5.20)*** [£2.23 + £2.97)] £2.08 £2.45 £2.97 £0.88 £73.62 (30) £24.95 (30) £33.96 (30) £60.48 (30) £25.00 (30) £30.00 (30) £35.00 (30) £70.00 (30) £24.04 (30) £24.04 (30) £28.86 (30) £33.66 (30) £57.72 (30) £67.32 (30) £56.00 (28) £58.52 (28) £65.52 (28) £76.16 (28) £124.04 (28) £131.04 (28) £141.68 (28) £62.46 (28) (£124.92)*** £83.28 (28) (£145.60)*** £58.24 (28) £68.60 (28) £83.16 (28) £24.75 (28) Cost per year (365 days)* 5mg OD is £36.87; 5mg TDS is £110.61 10mg OD is £66.80; 10mg BD is £133.60 £379.48 £447.86 £516.48 £827.33 06/01/16 (Inc. VAT). Figures from 21 IMPORTANT: This guideline does not replace the relevant NICE guidance, the BNF or the individual drug summary of product characteristics (SPC), which should all be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. West Kent CCG ADHD Shared Care Guideline Version 2.0 March 2016 Final