Version Control Summary Version Date Comments / changes 1.0 June November January 2009

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1 Document Control Summary Title Purpose of document Electronic file reference (authors) Electronic file reference (network or intranet) Status Draft 4 Version 1 Author(s) Name and position Circulated to METHYLPHENIDATE Shared Care Guideline To provide guidance on the shared care of children and adolescents aged 4-6 years (unlicensed) and 6-18years receiving methylphenidate Sophie Moinon CAMHS Pharmacist East London NHS Foundation Trust Roshan Jayaseelan Interim Pharmaceutical Adviser City and Hackney PCT East London Medicines Committee Group Approved by East London CAMHS Consultants Group First edition February 2009 Review date January 2011 All comments and ammendments to Sophie Moinon, CAMHS Pharmacist Version Control Summary Version Date Comments / changes 1.0 June November January 2009 East London Methylphenidate SCG Jan 09.doc Page 1 of 11

2 Methylphenidate Shared Care Guideline Attention Deficit Hyperactivity Disorder (ADHD) / Hyperkinetic Disorder (HKD) TERMINOLOGY There are 2 classification systems in psychiatry used widely across the world, DSM-IV, mainly used in the USA and Australia, and ICD-10, used in Europe. Attention Deficit/Hyperactivity Disorder (ADHD) is a DSM-IV diagnosis requiring the presence of symptoms of inattention and impulsivity or hyperactivity. It occurs with a prevalence of about 5% in the child population. Hyperkinetic disorder (HKD) is an ICD-10 diagnosis which requires the presence of both inattention and hyperactivity. As such, it occurs less commonly with a prevalence of about 1%. In the UK, we have traditionally used the ICD-10 classification system resulting in lower diagnosis rates than in the USA. However, ADHD is such a widely used and recognised name, that we have adopted it in the UK. Most UK psychiatrists use the term ADHD to refer to the narrower ICD-10 definition. INTRODUCTION Methylphenidate is used for the management of attention deficit hyperactivity disorder (ADHD), Attention Deficit Disorder (ADD), and Hyperkinetic Disorder (HKD) in children and adolescents. Methylphenidate is indicated as a part of a comprehensive treatment programme for ADHD where remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate to severe hyperactivity. Learning may or may not be impaired. Drug treatment of attention deficit hyperactivity disorder should be initiated by a specialist in ADHD but may be continued by general practitioners, under a shared-care arrangement. Treatment often needs to be continued into adolescence, and may need to be continued into adulthood. Methylphenidate treatment is not indicated in all children with this syndrome and the decision to use the drug must be based on a very thorough assessment of the severity of the child's symptoms. COST (BNF March 2008) Immediate release Methylphenidate (Ritalin ) 10mg tablet x 30 = 5.57 (Scored tablets) Methylphenidate (Equasym, Medikinet ) 5mg x 30 tablets = 2.78, 10mg x 30 tablets = 4.84, 20mg x 30 tablets = 9.98 Modified release Methylphenidate tablets (Concerta XL) 18mg x 30 = 29.70, 27mg x 30 = 35.06, 36mg x 30 = Methylphenidate capsules (Equasym XL) 10mg x 30 = 25.00, 20mg x 30 = 30.00, 30mg x 30 = Methylphenidate tablets (Medikinet XL) 10mg x 28 = 21.00, 20mg x 28 = 28.00, 30mg x 28 = 33.72, 40mg x 28 = East London Methylphenidate SCG Jan 09.doc Page 2 of 11

3 DOSE AND ADMINISTRATION i Attention deficit hyperactivity disorder Initiated by specialist in childhood behavioural disorders By mouth- Children aged 6 years and older and young people aged years old. Ritalin, Medikinet, Equasym tablets Child 4 6 years (unlicensed): 2.5mg twice daily increased if necessary at weekly intervals by 2.5mg daily to max. 1.4mg/kg daily in divided doses; discontinue if no response after one month, suspend every 1-2 years to assess child s condition ii. Children and young people 6-18 years: Initially 5 mg 1-2 times daily, increased if necessary at weekly intervals by 5-10mg daily to max. 60mg daily in divided doses; discontinue if no response after 1 month, suspend every 1-2 years to assess child s condition iii. NB: Tablets are scored so may be halved. Equasym XL capsules Children and young people 6-18 years: Initially 10mg once daily in the morning before breakfast, increased gradually if necessary to max. 60mg daily; discontinue if no response after 1 month, suspend every 1-2 years to assess child s condition. NB: Capsule may be opened & contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, & not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. Capsules and contents must not be crushed or chewed. Concerta XL tablets Children and young people 6-18 years: Initially 18mg once daily in the morning, increased if necessary in weekly steps of 18mg according to response, max. 54mg once daily; discontinue if no response after 1 month, suspend every 1-2 years to assess child s condition. NB: Total daily dose of 15mg of standard-release formulation is considered equivalent to Concerta XL 18mg once daily Counselling: Tablet membrane may pass through gastro-intestinal tract unchanged. Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Medikinet XL capsules Children and young people 6-18 years: Initially 10mg once daily in the morning with breakfast, adjusted according to response, max 60mg daily; discontinue if no response after 1 month, suspend every 1-2 years to assess child s condition. NB: Capsule may be opened & contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, & not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. Capsules and contents must not be crushed or chewed. See appendix 1 for a summary comparing the long acting preparations. Doses should be increased until core symptoms are adequately controlled. The minimum dose necessary to control symptoms should be used. The final dose of the day should not normally be given after 4 p.m. as Methylphenidate can cause/exacerbate sleeping problems in some children. However, there may be exceptions to this as in some children, a small evening dose of Methylphenidate is known to improve sleeping. In some children East London Methylphenidate SCG Jan 09.doc Page 3 of 11

4 rebound hyperactivity may occur if the effect of the drug wears off in the evening. An additional dose later in the day may eliminate this difficulty but may disturb sleep. CAUTIONS Caution is required in children with epilepsy, psychotic disorders or a history of drug or alcohol dependence. Concerta XL should not be used in patients with severe gastrointestinal tract narrowing or dysphagia or significant difficulty in swallowing tablets. NB: although the SPC contraindicates methylphenidate in children with history of tics or Tourette s in practice, it may be used with caution. See Summary of Product Characteristics (SPC) iv for comprehensive list of cautions. CONTRA-INDICATIONS Methylphenidate is contra-indicated in children with marked anxiety, agitation or tension or family history of tics or Tourette s syndrome, severe depression, severe hypertension, hyperthyroidism, thyrotoxicosis, severe angina or cardiac arrhythmias, glaucoma or known sensitivity to methylphenidate or excipients. NB: although the SPC contraindicates methylphenidate in children with history of tics or Tourette s in practice, it may be used with caution. See Summary of Product Characteristics (SPC) v for comprehensive list of contra-indications. SIDE- EFFECTS Headache and stomach-ache may occur on starting treatment but these go after a few days, possibly helped by taking the medication after food. Very common 10%: Nervousness & insomnia very common at start of treatment, but can usually be controlled by reducing the dosage and/or omitting the afternoon or evening dose. Common 1% to < 10%: Decreased appetite common but transient. Headache, drowsiness, dizziness, dyskinesia, hyperactivity, abdominal pain, nausea and vomiting (usually at beginning of treatment & may be helped by taking with food. Dry mouth, Tachycardia, palpitations, arrhythmias, changes in blood pressure and heart rate (usually an increase), rash, pruritus, urticaria, fever, arthralgia, alopecia, abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability Rare 0.01% to < 0.1%: Difficulties in visual accommodation & blurred vision, angina pectoris, moderately reduced weight gain and slight growth retardation during prolonged use Very rare < 0.01%: Hyperactivity, convulsions, muscle cramps, choreo-athetoid movements, tics or exacerbation of existing tics, & Tourette's syndrome, hallucinations, psychotic disorder, suicidal behaviour (including completed suicide), transient depressed mood, cerebral arteritis &/or occlusion, cardiac arrest, sudden death, abnormal liver function, thrombocytopenic purpura, exfoliative dermatitis, and erythema multiforme, fixed drug eruption, leucopenia, thrombocytopenia, anaemia, hypersensitivity reactions. Very rare reports of poorly documented neuroleptic malignant syndrome (NMS) have been received. In most of these reports patients were also receiving other medications. It is uncertain what role methylphenidate played in these cases. See Summary of Product Characteristics (SPC) vi for comprehensive list of side effects. CLINICALLY RELEVANT DRUG INTERACTIONS Methylphenidate increases the plasma concentration of phenytoin and delays intestinal absorption of phenytoin, phenobarbital (phenobarbitone), ethosuximide. Methylphenidate inhibits metabolism of tricyclic antidepressants and warfarin and possibly inhibits the metabolism of SSRIs. Dosages of these drugs may need reducing. Use cautiously in patients treated with pressor agents and MAOIs. Alcohol may exacerbate CNS adverse reactions of methylphenidate and although these are young patients they should be advised not to consume alcohol. East London Methylphenidate SCG Jan 09.doc Page 4 of 11

5 RESPONSIBILITIES Secondary Care/Specialist Service Responsibilities 1. Confirm the diagnosis of ADHD following full assessment, drawing upon information from all sources and first hand observation of the child. 2. Discuss treatment options with parent/carer(s) including medication. Explain the potential effects and side effects of methylphenidate. Explain the responsibilities of the parent/carer to the parent/carer & explain any medication changes to the patient, parent, &/or carer. 3. Undertake baseline history (inc. epilepsy, cardiovascular problems) and physical examination (inc. cardiac auscultation) before commencing stimulant medication. Ensure baseline monitoring of height, weight, pulse and blood pressure (BP) has been performed and recorded, plus undertake any additional relevant investigations. In patients with known or suspected cardiac or haematological history, refer to GP for further baseline investigations and subsequent monitoring (e.g. ECG, blood tests) as necessary. Routine baseline blood tests are not required. 4. Initiation of methylphenidate therapy and supply of the medicines for one further month after the dose has been stabilized. For details on initiation, please refer to Trust Protocol for the Treatment of ADHD in children and young people July 2007 vii. 5. Within 2 weeks of commencing treatment or adjusting the dose, the parent should be contacted (by appointment, telephone or standardised rating scale) to enquire about effect and side effects of treatment at home and at school. Standard side effect rating scales may be used. Independent reports from teachers are very helpful, but may be more difficult to obtain. Parental concerns should be addressed and the dose of medication should be adjusted according to reports. This process should be repeated until a stable dose is achieved. 6. Once dose titration is completed and the treatment is stable, arrange for the GP to continue prescribing and monitoring under a shared care arrangement and sent a copy of this Shared Care Guideline. The specialist service must prescribe methylphenidate until GP formally agrees to share care. 7. A template letter for commencing shared care is provided in appendix 2, although it is not compulsory to use this form as long as the correspondence is in writing. The correspondence should be sent after initial assessment and following each further appointment if changes occur. This should include any changes to the patient s medication regimen. 8. Inform GP of any changes to the prescription in writing and otherwise inform GP of the child s progress on a minimum 6 monthly basis. 9. Review the patient at regular intervals 3 monthly initially and then as necessary but all children should be seen at least twice a year by the specialist service. 10. Undertake the necessary monitoring at review appointments - Height, weight, pulse and blood pressure should be monitored at month 3, 6 and 12 during the first year on medication. Thereafter, monitoring should occur every 6 months. 11. Monitoring of full and differential blood counts at the discretion of the individual specialist. Patient can be referred to GP to carry out the blood tests. Refusal by a child to comply with the blood test should not contra-indicate the use of methylphenidate. 12. Decision to recommend long-acting methylphenidate if appropriate. 13. Adjusting treatment as appropriate e.g. varying dosage or timing, drug holidays, and informing the GP of any changes in writing. 14. Continuing supply of methylphenidate for children under 6 years old. 15. Inform and decide with GP any action if patient has not been reviewed within 6 months of the last appointment. This can include the decision to continue treatment as before. 16. Stopping treatment when appropriate. 17. For patients aged years (depending on service provider) manage withdrawal prior to discharge or refer to appropriate adult mental health services. East London Methylphenidate SCG Jan 09.doc Page 5 of 11

6 Primary Care Responsibilities 1. Initial referral to a Consultant Child and Adolescent Psychiatrist or Consultant Paediatrician with expertise in ADHD, raising the possibility of ADHD. 2. Communicate any knowledge of environmental factors that may mitigate against the use of methylphenidate or affect compliance, e.g. history of drug abuse in family setting. 3. Not to initiate medication without referral to consultant 4. Give written consent to continue treatment under shared care guideline. An template response is provided in appendix 2, although it is not compulsory to use this format, as long as the correspondence is in writing. 5. Upon acceptance of shared care provide the patient with monthly prescriptions of methylphenidate. An accurate record must be kept of prescriptions issued which must be available for every consultation and request. Methylphenidate is a Schedule 2 Controlled drug. Concerns regarding requests for more repeat prescriptions than seem necessary should be passed on to the ADHD Clinic. 6. Arrange to see the patient at least annually to monitor their health and well-being. 7. Report and discuss with consultant any adverse effects of medication, possible drug interactions, changes to the patient s medication regimen, deteriorating behaviour, or relevant medical information including any test results. 8. If recurrent nosebleeds, bruising or infection occurs perform full and differential blood counts and refer to the specialist if necessary. It is the joint responsibility of the GP and Consultant to ensure the patient/parent/carer are aware of their responsibilities: 1. To attend appointments 2. To have the recommended tests 3. To inform the GP if health problems arise 4. To be aware of side effects listed in the patient information leaflet supplied with the medication and report any relevant symptoms. STOPPING TREATMENT In some children, symptoms of severe ADHD remit over time and medication may then be discontinued. Medication should be stopped for up to a week on an annual basis to assess the on-going need for Methylphenidate. Many families will have already omitted medication, either accidentally or purposefully, during the course of a year. If it is immediately apparent that ADHD symptoms are still present and disabling, medication may be recommenced. The medication may be stopped abruptly; there is no tailing off necessary. However on withdrawal of the medication careful supervision is necessary as depression as well as renewed over activity can be unmasked. The specialist may, when a child shows improvement and the condition appears stable, suspend treatment periodically in order to assess the need for continuation of therapy (drug holidays). As the symptoms of hyperactivity typically diminish during the course of adolescence, severe ADHD usually diminishes also, although patients may continue to complain of impulsivity and inattention. In the UK it is usual to tail off Methylphenidate as the young person completes their schooling. Treatment is usually discontinued prior to or during puberty; the specialist will advise. For patients aged years (depending on service provider) manage withdrawal prior to discharge or refer to appropriate adult mental health services. East London Methylphenidate SCG Jan 09.doc Page 6 of 11

7 MONITORING Parameter Efficacy Side effects Weight & height/ Growth development Pulse & Blood Pressure Full Blood Count Frequency of monitoring At each appointment At each appointment Baseline, months 3, 6 & 12, then 6 monthly Baseline, months 3, 6 & 12, then 6 monthly Baseline if clinically indicated e.g. medical history Rating scales may be used. Action Failure to gain weight appropriately - may require withdrawal. Monitor whilst taking medication to ensure within published range for age of child. Low threshold for repeated investigation rather than schedule for routine testing e.g. if recurrent infections or purpuric rash occur or if needed due to medical history By whom Specialist Specialist/GP Specialist Specialist GP ECG Only if known or suspected history GP SPECIALIST SERVICE CONTACT DETAILS City & Hackney City & Hackney Child & Family Consultation Service The John Scott Health Centre Woodberry Down Green Lanes London N4 2NU Tel: Fax: Consultant Dr. Susan Woollacott Consultant Dr Glenda Ericksen Tower Hamlets Tower Hamlets CAMHS West Team 1 st Floor, Outpatients Building Royal London Hospital London E1 1BB Tel: Fax: Consultant Dr. Rebecca Adams Consultant Dr. Harriet Stewart Tower Hamlets Child & Adolescent Psychiatry Wellington Way Centre 1a Wellington Way, Bow Road London E3 4NE Tel: Fax: Consultant Dr. Susanna Griffin Consultant Dr. Ruma Bose City & Hackney Child & Family Consultation Service 15 Homerton Row London E9 6ED Tel: Fax: Consultant Dr. Nikos Myttas Consultant Dr. Begum Maitra Consultant Dr. Mosun Dorgu Tower Hamlets Tower Hamlets CAMHS East Team Emanuel Miller Centre 11 Gill Street, Isle of Dogs London E14 8HQ Tel: Fax: Consultant Dr. Hanspeter Dorner Consultant Dr. Helen Bruce Newham Newham Child & Family Consultation Service York House 411 Barking Rd London E13 8AL Tel: Fax: Consultant Dr. Graeme Lamb Consultant Dr. Georgina Hawkes Consultant Dr. Cathie O Driscoll Consultant Dr. Cathy Lavelle These guidelines must be used in conjunction with the Summary of Product Characteristics (SPC) viii for each methylphenidate product, and the recommendations of the consultant responsible for the management of the ADHD. East London Methylphenidate SCG Jan 09.doc Page 7 of 11

8 APPENDIX 1 Summary Comparison of Methylphenidate Long Acting Preparations Product tmax Immediate Release Profile Medikinet 2.75h 50% immediate XL release Equasym XL 4.7h 30% immediate release Concerta XL 6.8h (Initial max after 1-2h) 22% (4mg) immediate release Duration (approx) 8h 8h 12h Dose/ application Capsule taken with, or after, breakfast once daily. Adjustable sprinkle option. Capsule taken before breakfast once daily. Adjustable sprinkle option. Fixed dose tablet. Must be swallowed whole, with or without food. Available as 10mg 20mg 30mg 40mg 10mg 20mg 30mg 18mg 36mg 54mg Dosage Steps Maximum dose Comments Starting dose 10mg, increase by 10mg at weekly intervals Starting dose 10mg, increase by 20mg at weekly intervals Starting dose 18mg, increase by 18mg at weekly intervals Maximum dose as for Equasym XL (60mg/day) Max 60mg/day (licence). Recommended some patients need higher doses up to 2mg/kg/day or 100mg total daily doe, whichever is smaller ii 54mg (licence). Higher doses considered up to 2mg/kg/day or 108mg total daily dose, whichever smaller x Effects once daily Medikinet XL comparable to twice daily Ritalin ix Uncoated pellets dissolve within 30 minutes. Coated pellets dissolve 3-4 hrs later Capsules comprise both immediate release and extended release beads Osmotic pump system (OROS ), designed to have 12 hour duration of effect. Can titrate straight onto Concerta XL without first using immediate release xi East London Methylphenidate SCG Jan 09.doc Page 8 of 11

9 APPENDIX 2 Correspondence for commencing shared care of methylphenidate Section 1 to be completed by Hospital Specialist Consultant/Hospital Specialist request for shared care from GP Dear Dr. (insert GP name) Date: Name of patient: D.O.B.. Hospital No: Diagnosed condition: I recommend the prescribing of the following drug (state full name, dose, strength and formulation to be prescribed): This drug has been accepted as suitable for shared care by the East London NHS Foundation Trust and..primary Care Trust. I am requesting your agreement to sharing the care of this patient. The preliminary tests set out in the guideline have been carried out. The patient is currently on a maintenance treatment dose prescribed by myself at the Specialist Clinic. The maintenance dose will be continued to be prescribed by the Specialist Centre until shared care treatment can be undertaken by you. I would like you to undertake treatment from (insert date) The initial treatment will be: The baseline tests are: If you undertake treatment I will reassess the patient in.. weeks. You will be sent a written summary within 14 days. I will accept referral for reassessment at your request. The medical staff of the department are available at all times to give you advice. Consultant/Specialist Name:. Signature: Contact telephone number: Department: Hospital:... East London Methylphenidate SCG Jan 09.doc Page 9 of 11

10 Date:. Section 2 to be completed by GP Shared Care Prescribing Response Letter Re: Patient Name:.D.O.B: Hospital No: G. P. Response Please circle one of the following. A. I am willing to undertake shared care as set out in Shared Care Guidelines for this patient B. I wish to discuss this request with you. C. I am unable to undertake shared care for this patient because Comments: I will follow the advice in the methylphenidate Shared Care Guidelines. G.P Name / Stamp:. Signature:. Date:. (Please return whole completed form or a photocopy to the consultant/specialist requesting Shared Care Prescribing within one week of receiving this form). East London Methylphenidate SCG Jan 09.doc Page 10 of 11

11 REFERENCES i British Medical Association, the Royal Pharmaceutical Society of Great Britain, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacists Group. BNF for Children London: BMJ Publishing group, RPS Publishing, RCPCH Publications Ltd, ii British Medical Association, the Royal Pharmaceutical Society of Great Britain, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacists Group. BNF for Children London: BMJ Publishing group, RPS Publishing, RCPCH Publications Ltd, iii British Medical Association, the Royal Pharmaceutical Society of Great Britain, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacists Group. BNF for Children London: BMJ Publishing group, RPS Publishing, RCPCH Publications Ltd, iv v vi vii East London NHS Foundation Trust. Protocol for the Treatment of ADHD in children and young people, Updated July viii ix Döpfner M, et al. Comparative efficacy of once-a-day extended release methylphenidate, two-times-daily immediaterelease methylphenidate, and placebo in a laboratory school setting. Eur Child Adolesc Psychiatry. 2004;13(1):I x Banaschewski T, et al. Long acting medications for the hyperkinetic disorders. Eur Child Adolesc Psychiatry. 2006;15(8): 1-20 xi Swanson J, et al. Initiating Concerta TM (Oros methylphenidate HCl) qu in children with attention-deficit hyperactivity disorder. J Clin Res. 2000;3:59-76 East London Methylphenidate SCG Jan 09.doc Page 11 of 11