Worcestershire Area Prescribing Committee Guideline

Transcription

1 Worcestershire Area Prescribing Committee Guideline Attention Deficit Hyperactivity Disorder (ADHD) in Adults, Adolescents and Children Prescribing Guidelines and Shared Care for GPs, locum doctors and specialists Ratified by: Area Prescribing Committee Date of Ratification 2nd June 2009 This Policy should not be used after end of: 2nd June 2013 (12 month extension approved by APC on 2 nd October 2012) CONTRIBUTION LIST Key individuals involved in developing the document Name Sue Lunec Alan Pollard, Designation Senior Pharmaceutical Adviser Chief Pharmacist, Worcestershire Mental Health Partnership NHS Trust Circulated to the following individuals for comments Name Designation Specialist Children s Services Consultant Group Ruth White Consultant Psychiatrist Worcestershire Mental Health Partnership NHS Trust Expiry date: June 2013 Page 1 of 17

2 Contents 1.0 Children up to 18 years of age Introduction Diagnosis Choice of Therapy Local guidance Adjunctive Therapy Methylphenidate Prescribing Information Pre-drug treatment assessment Ongoing monitoring Contra-indications Cautions Formulations Dosage and Administration Formulations available Side-effects Drug Interactions Dexamphetamine Prescribing Information Pre-drug treatment assessment Contra-indications Cautions Dosage and Administration Side-effects Drug Interactions Atomoxetine Prescribing Information Pre-drug treatment assessment Contra-indications Cautions Dosage and Administration Side-effects Drug Interactions Melatonin Prescribing Information Adults 6.1 Introduction Modified Symptoms of adult ADHD Patient Groups Treatment interventions Pre-drug treatment and assessment and monitoring Drug Choice Discontinuation of treatment References ADHD shared care for prescribing Methylphenidate, Dexamfetamine and Atomoxetine for children and adolescents and into adulthood Patient Information Leaflet 18 Expiry date: June 2013 Page 2 of 17

3 Attention Deficit Hyperactivity Disorder (ADHD) in Adults, Adolescents and Children Prescribing Guidelines and Shared Care for GPs, locum doctors and specialists 1.0 Children up to 18 years of age 1.1 INTRODUCTION Attention Deficit Hyperactivity Disorder (ADHD) is a relatively common childhood behavioural disorder, prevalence estimates depend to a great extent on diagnostic measures used, diagnostic criteria and a number of other factors but conservative estimates would put the prevalence rates of ADHD at 1-5% of school-aged children with a male: female ratio of 3:1. The core features of children with ADHD are hyperactivity, inattention and impulsiveness. These are present in structured environments such as classrooms and in unstructured environment. ADHD often coexists with other conditions such as oppositional defiant disorder, conduct disorder, learning disorders, substance misuse, anxiety, depression, epilepsy, tic disorders and Tourette s syndrome. ADHD is a complex, clinical condition to diagnose and manage. It often involves many professionals including general practitioners, health visitors, teachers, psychologists, psychiatrists, nurses, paediatricians and social workers. Following initial diagnosis, there is formulation of an individualised treatment package reflecting the specific needs of the child or young person and their family. 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. In school age children with moderate ADHD parents should be offered a parenttraining/education programme and CBT and/or social skills training for the child or young person. Medication should be reserved for children and young people where non-drug interventions have been refused, where there is persisting significant impairment following parent-education/training or if the child or young person has been diagnosed with severe ADHD (hyperkinetic disorder) with severe impairment. Interventions can broadly be divided into non-pharmacological and pharmacological. These guidelines will focus solely on pharmacological interventions and should be read in conjunction with the current Summary of Product Characteristics (SPC). Pharmacological interventions are indicated in children and young people who have severe, pervasive and impairing symptoms of ADHD, or where other interventions have been unsuccessful and children s symptoms remain impairing. NICE has published an Appraisal supporting prescribing for ADHD on which these guidelines are based DIAGNOSIS The diagnosis should be made by a child psychiatrist or paediatrician. There are two mains sets of diagnostic criteria in current use. 1. The Diagnostic and Statistical Manual of Mental Disorders 4 th edition (DSM-IV) criteria define ADHD broadly to include three subtypes; a combined subtype In which all 3 core signs are present a predominantly inattentive subtype in which inattention is present but no hyperactivity or impulsiveness. A predominantly hyperactive impulsive subtype in which hyperactivity and impulsiveness are present but not inattention. Expiry date: June 2013 Page 3 of 17

4 2. The DSM-IV definition of severe combined-type ADHD is similar to the International Classification of Mental and Behavioural Disorders 10 th revision (ICD-10) definition of hyperkinetic disorder. The ICD-10 definition of hyperkinetic disorder requires abnormal levels of inattention, hyperactivity and impulsivity for at least 6 months. There is a place for the use of checklists/ rating scales such as Conners or ASEBA (Achenbach System of Empirically Based Assessment). Continuous performance tasks such as the Gordon Diagnostic System or assessments of physical activity may also have a place. 1.3 CHOICE OF THERAPY NICE does not recommend drug therapy for pre-school children (interpreted as under 4 years of age in this guideline). Methylphenidate is recommended first line with atomoxetine second line as below. NICE also noted that the evidence of effectiveness and licensing for dexamfetamine was limited and that it has a greater potential for diversion and misuse. The MHRA has issued safety advice regarding both methyphenidate and atomoxetine which is reproduced below LOCAL GUIDANCE First line - methylphenidate Second line - atomoxetine (Strattera) according to the following NICE guidance; Those who have not responded to methylphenidate at maximum tolerated dose Those who have been unable to tolerate methylphenidate (e.g. due to decreased appetite, growth problems, sleep disturbance, depressed mood or mood lability or exacerbation of co-morbid tics) Where TICS, Tourette s syndrome, anxiety disorder, stimulant misuse or risk of stimulant diversion are present. Furthermore, the decision regarding which product to use should be based on the following: A pre-drug treatment assessment Presence of co-morbid conditions e.g. epilepsy The different adverse effects Compliance and the school s policy with regards to controlled drugs The potential for drug diversion and misuse The views of the patient / parent or carer When all else is equal, the cost of the drug and preparation Because of the delay in onset of action of atomoxetine, the concurrent use of methylphenidate may be required in the titration phase of atomoxetine when transferring patients over to it. Third line dexamfetamine Consider when unresponsive to maximum tolerated doses of methylphenidate or atomoxetine. Fourth line Requires consultation with CAMHS psychiatrists. Further treatments may include unlicensed use of bupropion, clonidine, modafinil and imipramine or combination treatments. Expiry date: June 2013 Page 4 of 17

5 1.5 ADJUNCTIVE THERAPY Melatonin -. Poor sleep is often associated with ADHD. Melatonin, is often used to assist with sleep problems, in conjunction with sleep hygiene measures. It tends to be more effective if used intermittently rather than every night. Please see separate guidance on use of melatonin, noting that use in children sits outside of product licence for Circadin 2. METHYLPHENIDATE PRESCRIBING INFORMATION Licensed for children 6 years and older. Schedule 2 CD 2.1 Pre-drug treatment assessment (to be documented) Full mental health and social assessment including past and present psychiatric disorders or symptoms. Full history and physical examination including family history of sudden cardiac death, unexplained death, cardiac disease or malignant arrhythmia. History of exercise syncope, undue breathlessness, cardiovascular symptoms. Height and weight on a growth chart Heart rate and blood pressure plotted on a centile chart. Concomitant medicines Assessment for substance misuse or drug diversion Further investigations if there is a past medical history, indication of, or family history of cardiac disease or sudden death in a young family member. Caution when prescribing for patients with underlying medical conditions that might be compromised by increased heart rate or blood pressure. 2.2 Ongoing Monitoring Symptoms and side-effects should be recorded by parents and carers (adult patients) at each dose change and monitored and recorded by clinicians. Blood pressure and pulse should be recorded on a centile chart every 6 months and at every dose adjustment. Patients developing palpitations, exceptional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of heart disease should undergo prompt specialist cardiac evaluation. Height, weight and appetite should be reordered on a growth chart every 6 months Development of new or worsening of pre-existing psychiatric symptoms should be monitored every 6 months and at every dose adjustment Look out for signs of diversion, misuse and abuse of drugs Review progress regularly using weekly telephone contact if appropriate After titration and stabilisation carry out prescribing and monitoring under the shared care agreement. Interrupt treatment at least once a year to determine whether continuation is necessary. 2.3 Contra-indications The prescribing information below is guidance and should be used in conjunction with the manufacturer s Summary of Product Characteristics. Contra-indicated for those with a history or diagnosis of severe depression, anorexic disorders, suicidal tendencies, psychotic symptoms, mania, schizophrenia, severe mood Expiry date: June 2013 Page 5 of 17

6 disorders or psychopathic or borderline personality disorder, severe or episodic (type 1) bipolar (affective) disorder that is not well controlled. Contra-indicated in pre-existing cardiovascular disorders e.g. cerebral aneurysm and vascular abnormalities including vasculitis or stroke. *Unless specialist cardiac advice has been obtained, contra-indicated in pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and dysfunction of cardiac ion channels. : Glaucoma Hyperthyroidism, thyrotoxicosis Current/ recent (within 14days) treatment with MAOI s Motor tics, or family history of Tourette s syndrome * *Although these two are listed as contraindications, in some circumstances, methylphenidate can be used with caution and careful monitoring by specialist. In such cases the GP MUST be informed and may refuse to prescribe under shared care. 2.4 Cautions 2 EPILEPSY - Use with caution in epilepsy. If seizure frequency increases, the specialist should discontinue methylphenidate. HYPERTENSION - Methylphenidate increases heart rate and systolic and diastolic blood pressures. Therefore, caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction. 2.5 Formulations Timed release formulations should be considered for convenience, their pharmacokinetic profile, improved compliance, reduced stigma (no doses at school), reduced problems of storage and administration of controlled drugs in schools. Immediate release preparations should be considered if more flexible dosing is required or during titration. 2.6 Dosage and administration: Maximum licensed doses and above should only be considered after review and consultation with specialist CAMHS psychiatrists and followed by close monitoring for side-effects. Gradually increase doses over 4 6 weeks Immediate release methylphenidate (available as generic, Ritalin & Equasym) is a short acting medication, which reaches peak blood levels in about 2 hours and lasts 3 to 4 hours. Dose: 5mg twice or 3 times a day (usually avoiding administration after 4pm) Increased if necessary by 5 mg increments. Maximum licensed dose is 60mg daily in 2 or 3 divided doses, although it may sometimes be needed up to four times a day. In addition most specialists will calculate the maximum dose according to the European and NICE guidelines (0.7 mg/kg/dose) and therefore the total daily dose may be 90mg (100mg for adults). Equasym XL capsules contain small beads which release their contents over a longer period of time and cover around 8 hours and are given once daily. Expiry date: June 2013 Page 6 of 17

7 Dose: 10mg in the morning before breakfast Increased if necessary by weekly increments of 10mg to a Maximum of 60mg per day but see above. Patients already established on immediate release methylphenidate can be switched to the milligram equivalent daily dose of Equasym XL (e.g. methylphenidate 10mg twice daily is equivalent to 20mg of Equasym XL). Patients already established on immediate release methylphenidate can be switched to Equasym XL using the following equivalents: 5mg methylphenidate three times daily no equivalent 5mg methylphenidate four times daily or 20mg daily dose 20mg once daily 10mg methylphenidate three times a day 30mg once daily 20mg methylphenidate three times daily 60mg once daily Concerta XL tablets are designed to give an even longer duration of action, ten to twelve hours, although in practice, symptom control may be for a shorter period. Dose: 18mg in the morning Increase if necessary by increments of 18mg at weekly intervals Maximum licensed dose is 54mg per day, however as with immediate release methylphenidate specialists may use doses that are substantially higher depending on the weight of the patient. Patients already established on immediate release methylphenidate can be switched to Concerta XL using the following equivalents: 5mg methylphenidate three times daily 18mg once daily 10mg methylphenidate three times daily 36mg once daily 15mg methylphenidate three times daily 54 mg once daily 2.7 Formulations Available Drug Preparation Doses Comments Methylphenidate Generic 5mg, 10mg,20mg tablets Ritalin and Equasym can be halved Ritalin Equasym 10mg tablets 5mg,10mg.20mg tablets Methylphenidate modified release Concerta XL Equasym XL 18mg, 27mg, 36mg, tablets 10mg, 20mg, 30mg capsules Sometimes a combination of slow release and immediate release medication is required to give coverage over the full day. It is essential that type of medication, dose, and timing are tailored for each particular patient and frequent monitoring and adjustments may be required in the early stages of treatment, particularly with immediate release methylphenidate. Expiry date: June 2013 Page 7 of 17

8 Generally, concordance is better with slow release medication, particularly with the adolescent age group. If improvement in symptoms is not seen after appropriate dosage adjustment over a onemonth period, the drug should be discontinued. Treatment should also be discontinued periodically to assess the child s condition. 2.8 Side effects: Dizziness, nervousness, drowsiness and headaches are commonly experienced upon initiation of therapy. Loss of appetite (some weight loss may occur) and insomnia may also occur. These are often mild and transient and may be controlled by a reduction in dose. Other adverse effects include: abdominal pain, nausea and vomiting (can be alleviated by taking dose with food), dry mouth, emotional lability, temporary growth retardation (height should be monitored), changes in blood pressure, tachycardia, palpitations, skin rash, itching or bruising. 2.9 Drug interactions (please consult latest BNF / SPC for further information) Can enhance anticoagulant effect of warfarin. Can increase the plasma levels of some anticonvulsants (phenytoin, primidone, phenorbarbitone) and tricyclic antidepressants. Can exacerbate CNS adverse effects of alcohol (abstention advised). Should be used with caution with MAOIs and pressor agents (e.g. ephedrine) Concurrent use of methylphenidate and atomoxetine does not cause increased side effects of either drug. There are no known interactions with antibiotics, simple analgesics and antihistamines commonly prescribed for children. 3. DEXAMPHETAMINE PRESCRIBING INFORMATION - licensed for children of 3 years and over. Schedule 2 CD 3.1 Pre-drug treatment assessment Full mental health and social assessment Full history and physical examination including history of exercise syncope, undue breathlessness, cardiovascular symptoms, weight, family history of cardiac disease. Heart rate and blood pressure plotted on a centile chart. An ECG if there is a past medical or family history of serious cardiac disease, sudden death in a young family member of abnormal findings. Assessment for substance misuse or drug diversion. Only clinicians with expertise in managing both ADHD and substance misuse should prescribe in these circumstances. 3.2 Contraindicated In patients with: Known intolerance of sympathomimetic amines. Current or recent (within 14 days) treatment with MAOI s Glaucoma. Hyperthyroidism. Marked anxiety, agitation, tension or psychosis Some cardiovascular diseases * Motor tics, or family history of Tourette s syndrome * Expiry date: June 2013 Page 8 of 17

9 *Although these last two are listed as contraindications, in some circumstances, dexamphetamine can be used with caution and careful monitoring by specialist. In such cases the GP MUST be informed and may decline to prescribe under shared care. 3.3 Cautions Use with caution in epilepsy. If seizure frequency increases, the specialist should discontinue dexamphetamine. Use with caution in renal impairment. 3.4 Dosage and administration: Dexamfetamine (Dexedrine) is available as a 5mg scored tablet which can be halved. Children over 6 years: Adults 5-10mg a day in divided doses, increased if necessary by 5mg a day at weekly intervals to maximum 40mg daily. 5mg twice a day increased up to maximum of 60mg/day 3.5 Side effects: Dizziness, nervousness, drowsiness and headaches are commonly experienced upon initiation of therapy. Loss of appetite (some weight loss may occur) and insomnia may also occur. These are often mild and transient and may be controlled by a reduction in dose. Other adverse effects include: abdominal pain, nausea and vomiting (can be alleviated by taking dose with food), dry mouth, emotional lability, temporary growth retardation (height should be monitored), changes in blood pressure, tachycardia, palpitations, skin rash, itching or bruising. 3.6 Drug interactions (please consult latest BNF for further information) Effects of dexamphetamine can be decreased by: beta-blockers (e.g. propranolol), lithium and phenothiazines. Concurrent use of beta-blockers may result in severe hypertension. Concurrent use of tricyclic antidepressants may increase risk of cardiovascular side effects. Concurrent (or recent) use of MAOI s may precipitate hypertensive crisis. Acute dystonia has been noted with concurrent administration of haloperidol. 4. ATOMOXETINE PRESCRIBING INFORMATION - Licensed for use in children of 6 years and over 4.1 Pre-drug treatment assessment Full mental health and social assessment Full history and physical examination including history of exercise syncope, undue breathlessness, cardiovascular symptoms, weight, and family history of cardiac disease. Heart rate and blood pressure plotted on a centile chart. An ECG if there is a past medical or family history of serious cardiac disease, sudden death in a young family member of abnormal findings. Expiry date: June 2013 Page 9 of 17

10 Assessment for substance misuse or drug diversion. Only clinicians with expertise in managing both ADHD and substance misuse should prescribe in these circumstances. 4.2 Contraindicated in: Patients on MAOIs (or within 2 weeks after discontinuing therapy with a MAOI) Patients with narrow angle glaucoma. 4.3 Cautions 2 : Pre-existing psychotic or manic symptoms Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems: Sudden death has been reported in children and adolescents with structural cardiac abnormalities who were taking atomoxetine at usual doses. Atomoxetine should only be used with caution in children or adolescents with known serious structural cardiac abnormalities and in consultation with a cardiac specialist Pregnancy / breastfeeding History of seizures History or family history of long QT or QT prolongation Due to potential for additive pharmacological effects, caution is advised in patients with hypertension, tachycardia, cardiovascular or cerebrovascular disease. Pulse and blood pressure should be measured periodically while on therapy. Use with caution in any condition that may predispose patients to hypotension. 4.4 Dosage and administration: Atomoxetine (Strattera) is available as 10mg, 18mg, 25mg, 40mg or 60mg capsules. The dose should be given once daily, morning or early evening, with or without food. The total daily dose can also be taken as two divided doses with last dose no later than early evening. Unlike other treatments for ADHD, atomoxetine should be taken every day without drug holidays. All strengths are available in a 7-day starter pack and packs of 28. All strengths are priced the same so it is cost-effective to round up or down so that only one strength is used wherever possible. Body Weight <70kg >70kg Hepatic impairment Recommended Initiation doses & dosage titrations Usually 0.5mg/kg/day, titrate upwards if necessary, in 7 day intervals. Usually 40mg/day, titrate upwards if necessary, in 7 day intervals Halve dose in moderate and quarter dose in severe impairment Recommended maintenance dose Usually 1.2mg/kg/day (max 1.8mg/kg/day) Usually 80mg/day (max 120mg/day) Maximum doses only after review and consultation with CAMHS psychiatrists and in conjunction with close monitoring for side-effects. Unlicensed administration: The capsules can be opened and the powder dissolved in fruit juice. A 60mg capsule requires 60ml of liquid. Only acid liquids such as fruit juices have been studied. The mixture should be stirred and left for about 5 minutes to ensure all the powder Expiry date: June 2013 Page 10 of 17

11 has dissolved. The powder itself is irritant to eyes and possibly skin so the carer should wash hands afterwards and ensure the child does not get powder or liquid on skin or in eyes. This is information from the manufacturer, Lilly but is outside of the license. They have no plans for producing a liquid formulation. 4.5 Side effects and monitoring Suicidal ideation (CSM / NICE advice) patients and carers should be informed about this rare side-effect and told to report emergent psychotic or manic symptoms e.g. hallucinations, delusional thinking, mania or agitation, clinical worsening of behaviour, unusual changes in behaviour (particularly initially) irritability, depression, self-harming behaviour or suicidal thoughts. If symptoms occur consider the possibility of a causal role of atomoxetine and discontinuation of treatment. Hepatic Disorders (CSM advice) children and carers should be advised of the risk and told how to recognise symptoms. Prompt medical attention should be sought in case of abdominal pain, unexplained nausea, malaise, darkening of urine or jaundice. Increase in pulse and BP: patients may experience a modest increase in pulse (mean<10 bpm) and /or increase in blood pressure (mean<5mmhg). In most cases these are not clinically important. GI disturbance: treatment may be associated with transient gastrointestinal side effects such as dry-mouth, abdominal pain, nausea, vomiting, decreased appetite, constipation, flatulence and dyspepsia. Other common side-effects include fatigue, somnolence, early wakening, irritability, mood swings, mydriasis, dizziness, dermatitis, pruritis, rash, weight loss, decreased libido, erectile or ejaculatory disorder, insomnia, headache, palpitations, hot flushes, sweating, urinary retention or hesitancy, dysmenorrhoea or menstrual irregularities. 4.6 Drug interactions: (please consult latest BNF for further information) o MAOI s o Drugs that prolong QT interval (e.g. antipsychotics, erythromycin) o Drugs known to lower seizure threshold (e.g. antidepressants, antipsychotics, tramadol) o High doses nebulised or systemically administered salbutamol (or other beta2 agonists) o Pressor agent (e.g. the decongestants pseudoephedrine or phenylephrine) o Drugs that affect noradrenaline (e.g. antidepressants such as imipramine, venlafaxine and mirtazapine) o Drugs which inhibit CYP2D6 isoenzyme (e.g. fluoxetine, paroxetine) - slower titration may be necessary. Concurrent use of atomoxetine and methylphenidate does not cause increased side effects of either drug. There is no interaction between atomoxetine and alcohol. Although improvements in symptoms may occur after four weeks with atomoxetine, in practice six to eight weeks is more realistic and occasionally longer periods. It is important to enquire very carefully about improvement, since patients and parents may overlook them, and conclude that medication has not been effective. 5. MELATONIN Please refer to Melatonin Prescribing Guidance and Shared Care Agreement Expiry date: June 2013 Page 11 of 17

12 Attention Deficit Hyperactivity Disorder (ADHD) in Adults, Adolescents and Children Prescribing Guidelines and Shared Care for GPs, locum doctors and specialists 6.0 Adults 6.1 Introduction The National Institute for Health and Clinical Excellence (NICE) recognises that signs of ADHD may persist into adulthood with associated emotional and social problems 1. Also whilst a primary diagnosis of ADHD is not made in adults, a retrospective diagnosis based on appropriate history may be made. Adults with untreated ADHD symptoms utilise a high degree of primary care resources, often attract poor employment records, have more motor vehicle accidents and present with high degree of co-morbid psychiatric disorders and substance misuse. The presentation of ADHD symptoms in adults is modified compared to children, although the same triad of core symptoms is present (see table below). Likewise the same types of medication remain the most widely used and best evidenced treatment for adult ADHD 3. Adult lifestyles such as longer days and active evenings may require different dosing strategies and often require proportionally higher doses of stimulants compared with children. 6.2 Modified symptoms of adult ADHD Core Symptom Hyperactivity Inner restlessness Impulsivity Modified Presentation in Adults Overt over activity may present more as inner restlessness and purposeful over activity in adults causing tension. May be seen in: impulse control problems in decision making, driving, relationships, shopping Sensation seeking behaviour leading to risk taking Low frustration threshold Inattention Deficit in executive functioning may present as : difficulty in planning, decision making, self organisation, initiation and completion of tasks Over focusing on detail and lacking overview Poor time management, procrastination, forgetfulness Difficulties in attentive reading and listening to others Expiry date: June 2013 Page 12 of 17

13 6.3 Patient groups 1. Graduate Patients Latest estimates cite up to 65% of ADHD children presenting with at least some symptomology into adulthood and 15% meeting full diagnostic ADHD criteria at age 25. Patients under the care of the CAMHS services will not be passed in to adult services until they reach 18 years of age. At this point the adult psychiatrist together with the multidisciplinary team will review the treatment in place and inform primary care of the latest treatment plan. 2. Patients diagnosed in adulthood As awareness of adult ADHD increases there will be cases of previously undiagnosed clients being identified. Retrospective diagnosis may be assisted by the use of modified rating scales a review of which can be found in the references 5. Retrospective diagnosis will always be made by a secondary care specialist but given that the diagnosis relies heavily on family history and collateral evidence the primary care physician who may have a much greater knowledge of the family is well placed to spot possible cases of missed ADHD and should have no hesitation in asking adult services to assess the situation. In such cases prescribing should be initiated by the specialist. 3. Parents of children with ADHD Due to the heritability of the condition special vigilance should be paid to parents of children with ADHD who themselves present with severe and enduring mental health problems. In such cases prescribing should be initiated by the specialist. 7. Treatment Interventions Treatment pathways are in principle no different to those for children but clearly the risks, contra-indications and tolerability issues may be different. The table below shows how adult treatment selections may be modified. It is generally advisable to treat co-morbid psychiatric conditions before starting treatment for ADHD. Whilst medication is still regarded as the principle intervention modified Cognitive Behavioural Therapy (CBT) alongside medication is believed to be superior to medication alone in managing core ADHD symptoms. For those with an affective disorder co-morbidity more specific psychotherapeutic interventions may be indicated to improve functional outcomes NICE recommends drug treatment first-line unless the person prefers psychological treatment. Drug treatment should be under the supervision of a prescriber specialising in ADHD and be part of a comprehensive treatment programme. No drug currently has a license for adult use 7.1 Pre-drug treatment assessment and ongoing monitoring As for 2.1 and 2.2. above 7.2 Drug Choice Methylphenidate should normally be tried first except where drug misuse or diversion is a possibility. Atomoxetine should be considered if unresponsive to methylphenidate after a trial of about 6 weeks. Antipsychotics are not recommended.. Expiry date: June 2013 Page 13 of 17

14 Medication Stimulants amphetamines, methylphenidate including m/r preparations Adult issues to consider- see child and adolescent guidance also Stimulants remain a first line option. Consider the risk of diversion of a Controlled Drug Adult day is much longer requiring more complex dosing strategies including combination of short and long acting regimens. BP monitoring strongly indicated. Check for drug interactions with any concomitant treatment Travelling abroad may require import licence depending on quantities needed for treatment. The permitted allowance is calculated on an average 15 day dosage. See and search taking medicines abroad for up to date permitted allowances. The current allowance for methylphenidate is 900mg and the same for dexamfetamine (900mg). Medication Adult issues to consider- see child and adolescent guidance also Atomoxetine Second line option for clients in whom stimulants are contraindicated or not appropriate. Like stimulants, high doses are likely to be needed 40mg BD may be better than 80mg OD 4 Somnolence and sleep disturbance may be problematic Remember small effect for first 4 weeks Erectile dysfunction, menstrual irregularities reported Combination and third line agents Monitor BP Co-morbid conditions and lifestyle requirements may endorse or pose increased risk with these agents. For example use of a tricyclic in a patient with co-morbid depression may be helpful whilst a client with co-morbid bipolar disorder may be at increased risk of a switch to mania under these circumstances. Melatonin Review all cases by looking at non-pharmacological ways to address sleeping difficulties For ongoing management of poor sleep a short course of licensed prescription hypnotics are available Only in refractory states is melatonin continued use justified ALL medications Consider safety in pregnancy /breastfeeding Impact on driving ability and operation of machines 7.3 Discontinuation of Treatment Until further evidence is available there is no clear point at which ADHD medication should be stopped. Emerging evidence would suggest long term benefit is maintained and any decision to stop treatment should be undertaken in a considered way involving patient, significant others and healthcare professionals involved in the patient s care. Good practice would suggest that an early signs framework is put in place whereby any signs of deterioration are recognised by patient and/or others so that a prompt return to medication can be instigated. There are also counselling and behavioural interventions that can be employed in adult ADHD. Expiry date: June 2013 Page 14 of 17

15 8.0 References 1 NICE Clinical Guideline 72: 2008 Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults 2. Drug Safety Update March MHRA Methylphenidate: updated guidance on safe and effective use in ADHD Atomoxetine: Risk of psychotic or manic symptoms 3. Evidence-based guidelines for management of attention-deficit/hyperactivity disorder in adolescents in transition to adult services and in adults: recommendations from the British Association for Psychopharmacology. Nutt DJ et al (2006) Journal of Psychopharmacology Summary of Product Characteristics for atomoxetine, methylphenidate 4. Adler L et al. Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD. Ann Clin Psychiatry 2006; 18: Assessing attention-deficit/hyperactivity disorder in adults: focus on rating scales Murphy KR, Adler LA. J Clin Psychiatry. 2004; 65 Suppl 3: Expiry date: June 2013 Page 15 of 17

16 9.0 SHARED CARE Attention Deficit Hyperactivity Disorder (ADHD) Shared Care for Prescribing Methylphenidate, Dexamfetamine and Atomoxetine for Adults, Children and Adolescents and into Adulthood This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of Methylphenidate and Atomoxetine for ADHD can be shared between the specialist and general practitioner (GP). Recent changes in the regulations and advice for prescribing controlled drugs has necessitated prescriptions for methylphenidate being a maximum of 28 days. This has put considerable strain on CAMHS and mental health physicians by requiring them to write many more prescriptions without the support of computers as in primary care. The participation of GPs in shared care would facilitate a more efficient service. The Area Prescribing Committee (APC) has agreed, in line with NICE guidance, that it is appropriate for GPs to prescribe within this shared care guideline for children, adolescents and adults (where they have previously prescribed for them as adolescents). Since prescribing for newly diagnosed adults is relatively new, the APC has agreed that GPs should be invited to prescribe within this shared care guideline. If the GP is not confident to undertake this role, then he or she is under no obligation to do so. In such event, the clinical responsibility for the patient, including issuing prescriptions, remains with the specialist. Specialist responsibilities (Consultant Psychiatrist, Paediatrician, associate specialist, supported by clinic nurse): Diagnose the condition and undertake a full mental health and social assessment including past and present psychiatric disorders or symptoms. Undertake a full history and physical examination including family history of sudden cardiac death, unexplained death, cardiac disease or malignant arrhythmia. History of exercise syncope, undue breathlessness, cardiovascular symptoms and undertake an ECG if appropriate. Plot heart rate and blood pressure on a centile chart. Plot height and weight on a growth chart if methylphenidate is to be prescribed Assessment for substance misuse or drug diversion. Only clinicians with expertise in managing both ADHD and substance misuse should prescribe in these circumstances. Concomitant medicines check Provide patient / carer with relevant information on use, side-effects and need for monitoring of medication. Explain any unlicensed uses. Suicidal ideation with atomoxetine parents, patients and carers should be informed about this rare side-effect to atomoxetine and told to report emergent psychotic or manic symptoms e.g. hallucinations, delusional thinking, mania or agitation, clinical worsening of behaviour, unusual changes in behaviour (particularly initially) irritability, depression, selfharming behaviour or suicidal thoughts. Hepatic Disorders with atomoxetine parents, patients and carers should be advised of the risk and told how to recognise symptoms and when to seek prompt medical attention Provide treatment until stabilised (at least three specialist appointments) Encourage parents and carers to record symptoms and side-effects at each dose. Arrange shared-care with patient s GP advising GP if the prescribing request is outside of license. Agree to review patient s condition when requested by the patient s GP Provide any other advice or information for the GP if required including rapid referral arrangements and contacts. Expiry date: June 2013 Page 16 of 17

17 Monitoring Review the treatment six monthly taking into account the views of all parties and sending a written summary to the GP whenever the patient is reviewed. Monitor response to treatment, BP, pulse, and side-effects according to NICE guidance Monitor height, weight and appetite and record on a growth chart every 6 months Monitor new or worsening psychiatric symptoms every 6 months and at dose changes (by telephone if appropriate) Advise discontinuation of medication if no improvement is seen after a reasonable trial. Discontinue treatment at appropriate intervals under careful supervision when condition stable, to assess the need to continue medication. Look out for signs of diversion, misuse and abuse of drugs GP responsibilities: Ensure that he/she has the information and knowledge to understand the therapeutic issues relating to the patient s clinical condition. Prescribe the ADHD medication adjusting in line with specialist recommendations (continued prescribing is appropriate for patients attending specialist review) Encourage parents and carers to record symptoms and side-effects at each dose change and to report to GP and specialist. Report significant deviations from the prescribing pattern to the specialist. Monitor and record the therapy between specialist reviews as necessary and based on the individual. Patients developing palpitations, exceptional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of heart disease should undergo prompt specialist cardiac evaluation. Refer to specialist if patient s condition deteriorates Suicidal ideation with atomoxetine parents, patients and carers should have been informed about this rare side-effect by the specialists and told to report emergent psychotic or manic symptoms e.g. hallucinations, delusional thinking, mania or agitation, clinical worsening of behaviour, unusual changes in behaviour (particularly initially) irritability, depression, self-harming behaviour or suicidal thoughts. Hepatic Disorders with atomoxetine parents, patients and carers should have been advised of the risk by the specialist and told how to recognise symptoms and when to seek prompt medical attention Report any adverse events to the specialist, and the usual bodies (e.g. CSM) Expiry date: June 2013 Page 17 of 17