E102 Conduct Disorder in Children and Young People (CYP 5-18 years of age) RISPERIDONE Effective Shared Care Agreement (ESCA) Patient details Name: Date of birth: NHS number: Contact details Specialist: Agreement to shared care, to be signed by GP and Specialist before prescribing is transferred to GP Secure email: Specialist Out-of-hours GP: GP Secure email: Patient: Patient This ESCA should be read in conjunction with the SPC Page 1
General principles This shared care agreement outlines the suggested ways in which the responsibilities for managing the prescribing of a pharmacological treatments to children and young people (CYP 5-18 years of age) with a diagnosis of conduct disorder can be shared between the Specialist and General Practitioner If the GP considers him or herself unable to take on this responsibility, then this should be discussed between the relevant parties so that additional information or support can be made available, or alternative arrangements made 1 The specialist will advise which medicines to prescribe, what monitoring will need to take place in primary care, how often medicines should be reviewed, and what actions should be taken in the event of difficulties 1 Brief overview of the disease 2 Conduct disorders, and associated antisocial behaviour, are the most common mental and behavioural problems in children and young people Conduct disorders are characterised by repetitive and persistent patterns of antisocial, aggressive or defiant behaviour that amounts to significant and persistent violations of age-appropriate social expectations. The prevalence of conduct disorders increases throughout childhood and they are more common in boys than girls. Conduct disorders commonly coexist with other mental health problems A diagnosis of a conduct disorder is strongly associated with poor educational performance, social isolation and, in adolescence, substance misuse and increased contact with the criminal justice system Introduction Treatment of conduct disorders should only be initiated following assessment and diagnosis by a specialist with training and expertise in conduct disorders. Before risperidone is prescribed to a child or adolescent with a conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands. Summary of NICE 2, BNF 3, SPC 4 or other guidance, where applicable Licensed indications & therapeutic class Conduct disorder in children and adolescents from 5 to 18 years of age Dose, route of administration and duration of treatment 500 microgram (0.5mg) tablet 1mg tablet Available 1mg/ml oral solution as: 500 microgram (0.5mg) orodispersible tablet 1mg orodispersible tablet Dose: (orodispersible preparations are an option where there are concerns around compliance) Child < 50 kg, initially 250 micrograms once daily, then increased in steps of 250 micrograms once daily on alternate days, if needed. The optimum dose is 500 micrograms once daily for most patients. Some patients, however, may require 750 micrograms once daily. Child 50 kg, initially 500 micrograms once daily, then increased in steps of 500 micrograms once daily on alternate days, if needed. The optimum dose is 1 mg once daily for most patients. Some patients, however, may require 1.5 mg once daily. This ESCA should be read in conjunction with the SPC Page 2
Review the effects of risperidone after 3 4 weeks and discontinue it if there is Duration: no indication of a clinically important response at 6 weeks. 2 As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an ongoing basis. 4 Adverse effects (incidence, identification, importance and management) 10% Very common 0.01 to < 0.1% Rare Below is a selected list of 1 to <10% Common < 0.01% Very adverse effects, refer to the 0.1 to <1% Uncommon rare product SPC for the full list Adverse effect and frequency Management Tardive Dyskinesia 1 to <10% Refer back to prescribing professional. A reduction in dose, discontinuation or a change to an alternative agent may be required Neuroleptic malignant syndrome (NMS) Somnolence/ drowsiness 0.01 to < 0.1% 1 to <10% Constipation 1 to <10% Refer immediately to emergency department and inform prescribing professional. Discontinue antipsychotic Restrict dose to night time only Recommend high fibre diet Consider adding a bulk-forming and/or stimulant laxative Dry mouth 1 to <10% Recommend chewing sugar-free gum Hypotension 0.1 to <1% Monitor blood pressure and refer if clinically appropriate Dizziness 1 to <10% Advise patient to take time to get up, refer if clinically appropriate Weight gain 1 to <10% Encourage a healthy balanced diet and regular exercise. Refer back to prescribing professional Increased prolactin levels 1 to <10% If symptoms of hyperprolactinaemia occur a reduction in dose may be required. Refer back to prescribing professional Cautions and contra-indications This information is not inclusive of all cautions and contra-indications. Please refer to full prescribing data on the SPC or the British National Formulary (BNF) Hypersensitivity to risperidone or to any excipients listed in the SPC Risperidone contains a source of phenylalanine (aspartame). It may be harmful for people with phenylketonuria Clinically important drug interactions and their management This information is not inclusive of all cautions and contra-indications. Please refer to full prescribing data on the SPC or the British National Formulary (BNF) Management Risk of QT interval prolongation when Avoid concomitant use administered with other QT prolonging drugs ECG Centrally-acting substances including alcohol, opiates, antihistamines and benzodiazepines may increase the risk of sedation CYP 3A4 inducers such as carbamazepine, rifampicin, phenytoin or others CYP 2D6 inhibitors such as fluoxetine, paroxetine, quinidine or others Avoid if possible Monitor for sedation If inducers are initiated or discontinued, the dose of risperidone will require reevaluation If inhibitors are initiated or discontinued, the dose of risperidone will require reevaluation This ESCA should be read in conjunction with the SPC Page 3
Specialist Peer-reviewed references for product usage Monitoring requirements and responsibilities 1. Confirm diagnosis of conduct disorder following full assessment 2. Carry out a pre-drug treatment assessment. This must include: a) A full mental health history and social assessment b) A full history and physical examination, including: o Assessment of history of exercise syncope, undue breathlessness and other cardiovascular symptoms o Pulse and blood pressure (plot on a centile chart) o Height and weight (plot on a growth chart) o Waist circumference (plot on a centile chart) o Fasting blood glucose o HbA1c o Blood lipid profile o Prolactin level o Family history of cardiac disease and examination of the cardiovascular system c) An electrocardiogram (ECG) if there is past medical or family history of serious cardiac disease, a history of sudden death in young family members or abnormal findings on cardiac examination 3. Initiate treatment and titrate the dose against symptoms and adverse effects in line with the BNF or BNF for Children until dose optimisation is achieved 2 4. After titration and dose stabilisation for a minimum of 3 months write to the patients GP to request agreement to shared care 5. Provide advice and support to parent/carers (including description of common drug side effects) and advice to teachers (where appropriate). Parents, teachers and children/young people should be asked to record symptoms and side-effects particularly at dose changes 6. Review patient annually or sooner if indicated 7. Monitor pulse and blood pressure 3 and 6 months after the start of treatment, and every 6 months thereafter or more often if concerns arise and compare with normal range for age. Additionally monitor before and after each dose change. 8. Monitor height measure every 6 months (plot on a growth chart) 9. Monitor weight measure weekly for the first 6 weeks then at 3 and 6 months after the start of treatment, and every 6 months thereafter or more often if concerns arise, plot on a growth chart 10. Monitor waist circumference measure every 6 months (plot on centile chart) 11. Monitor fasting blood glucose, HbA1c, lipids and prolactin levels at 3 and 6 months after the start of treatment, and every 6 months thereafter or more often if concerns arise 12. Monitor onset or worsening of psychiatric symptoms and symptoms suggestive of heart disease 13. Provide GP with regular reports on pulse, blood pressure, height, weight, waist circumference, fasting blood glucose, HbA1c, blood lipids and prolactin after each monitoring test 14. Stop treatment at any appropriate time, communicate change or cessation of treatment to GP GP 1. Respond to specialists request regarding shared care as soon as possible ensure that treatment has been initiated, titrated and stabilised before agreeing to shared care 2. Issue monthly prescriptions as advised by the specialist 3. Monitor the patients overall health and well-being (as well as parents/carers) This ESCA should be read in conjunction with the SPC Page 4
Patient/ parent/ carer annually (6 months after annual review with specialist) Monitor: Pulse and blood pressure Height and weight Waist circumference Fasting blood glucose HbA1c Blood lipid profile Prolactin level 4. Report adverse drug reactions to the specialist 5. Act upon results communicated by the specialist 6. Refer back to the specialist for early appointment if patient, parent/carer raise concerns 1. To attend appointments for annual review and physical health checks with specialist 2. To attend appointments with GP for physical health checks 6 months after annual review with specialist 3. To have the recommended tests 4. To inform the GP in health problems arise 5. To be aware of drug actions and side-effects and report any relevant symptoms (parents will be provided with written and verbal advice on sideeffects) Contacts for more detailed information For any queries relating to this patient s treatment with risperidone, please contact the specialist named on the front page of this document. References 1. NHSE Responsibility for prescribing between Primary & Secondary/Tertiary Care, Version 1.0. 29 Jan 2018 2. NICE CG158 Antisocial behaviour and conduct disorders in children and young people: recognition and management. Published March 2013, Last updated April 2017. https://www.nice.org.uk/guidance/cg158 Accessed <11/01/2019> 3. BNFc 2018/2019. Pharmaceutical Press 4. Risperidone. Summary of Product Characteristics for Risperdal 0.5mg. Last updated on the emc 06/2018. Accessed via: www.emc.medicines.org.uk on 11/01/2019 This ESCA should be read in conjunction with the SPC Page 5