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Effective Shared Care Agreement (ESCA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with Methylphenidate in Adults This form must be completed by the consultant and send to the GP for approval. It must be signed by the GP and returned to the consultant before the patient is informed that the GP will prescribe the drug. Patient’s Name: NHS Number: Date of Birth: Date Treatment Started: (Add Date) One copy of information leaflet given to patient One copy of agreement sent to general practitioner One copy filed in patients notes Name of Initiating Doctor: Consultant: Speciality: Fax Number: PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with methylphenidate (*delete as appropriate) GP Name: Signature: Date: Once signed please detach this sheet and fax to the number shown above. Patient’s Name: NHS Number: Date of Birth: Date treatment commenced: This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE The aim of an Effective Shared Care Agreement (ESCA) is to enable the sharing of patient care between primary and secondary care. The document should provide information to general practitioners (GPs) and hospital staff about complex or high cost therapies that their patients may receive following specialist referral. An ESCA will be used only when it has been agreed that shared care is an appropriate option, and will include a statement of specialist and GP responsibilities. ESCA’s will ensure that all GPs have sufficient information to enable them to undertake prescribing responsibility for specialist therapies and other therapies that may affect or interact with specialist therapies. It is not the intention to insist that GPs prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility for this drug is not so obliged. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES AND ROLES 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Specialist responsibilities Arrange comprehensive assessment of the patient and be responsible for making the diagnosis and considering alternative diagnoses, co-morbid diagnoses and cautions/ contraindications to treatment Seek carer/family views on baseline function. For adults with ADHD, drug treatment should be the first line treatment unless the person would prefer a psychological approach Drug treatment for adults with ADHD should be started only under the guidance of a psychiatrist ,nurse prescriber specialising in ADHD, or other clinical prescriber with training in the diagnosis and management of ADHD Following a decision to start drug treatment in adults with ADHD, methylphenidate should normally be tried first. Atomoxetine or dexamfetamine should be considered in adults unresponsive or intolerant to an adequate trial of methylphenidate (this should usually be about 6 weeks). Caution should be exercised when prescribing dexamfetamine to those likely to be at risk of stimulant misuse or diversion Initiate treatment with methylphenidate. Prescribe by brand for sustained release preparations. Send a letter and the shared care agreement form to the GP to obtain consent to share prescribing and monitoring responsibilities. Inform the GP promptly about changes in treatment or dosage, any important adverse events or if other interacting medicines are prescribed/recommended Monitor the patient's condition and response to treatment regularly and keep the GP informed Provide a comprehensive baseline physical assessment as recommended in the NICE guidelines, and ensure that height, weight, blood pressure, pulse and appetite are monitored at the recommended time intervals. Communicate the results of tests to the GP as soon as possible. Blood pressure and pulse should be monitored 3 monthly. Explain the possible side effects of the drug and interactions to the patient. Provide written guidance for patient (at specialist’s discretion) Be available for back-up advice on any of the above during working hours Report all suspected adverse drug reactions to the Medicines and Healthcare Regulatory This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 Agency (MHRA) via www.yellowcard.gov.uk 16 Send a letter and the shared care agreement form to the GP to obtain consent to share prescribing and monitoring responsibilities 17 Advise GP of any dosage adjustments required, when to refer back, and when and how to stop treatment 18 Ensure clear arrangements for back up, advice and support General Practitioner responsibilities 1. Prescribe the recommended drug once notified by the specialist after agreeing to the treatment programme. Prescribe by brand for sustained release preparations. 2. Ensure that the treatment is not continued if the patient fails to attend the specialist clinic for over a year 3. Check that patient is being monitored as specified in specialist responsibility 4. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment 5. Refer back to the specialist if the patient’s condition deteriorates 6. Monitor the patient for side effects and report all suspected adverse drug reactions to the specialist and to the MHRA via www.yellowcard.gov.uk 7. Stop the treatment if advised by the specialist Patient's role 1. Ask the specialist or GP anything he or she does not understand about the treatment 2. Try to put into practice any behavioural or psychological programmes and report back to the specialist about their effectiveness 3. Report any adverse effects to the specialist or GP 4. Attend agreed review appointments This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 BACK UP ADVICE AND SUPPORT Contact details Telephone number (Sandwell) Dr I Sohi 0121 612 8662 Dr S El-Hilu 0121 612 8661 Dr K Prasad 0121 612 8650 Dr S Khalil 0121 612 8647 Dr O Ahmed 0121 612 8658 Dr O Al-Gommer 0121 612 8659 (Wolverhampton) Dr S Regmi 01902 446660 Dr A Yusuf 01902 444014 Dr S Singh 01902 44779 Dr S Roy 01902 442996 Dr N Kar 01902 443668 Dr M Akhtar 01902 443979 Dr T Black 01902 443670 Dr S Subbarayan 01902 443669 (Learning Disabilities) Dr S Varghese 01902 572572 Dr A Gomez 01902 572572 Dr A Choudry 0121 612 8427 Dr J Lidher 0121 612 8424 Dr J Vella 0121 612 8433 Dr A Kirby 01384 323076 Dr K Tresize 01384 323557 Dr S Khan 01902 444021 Fax number 0121 612 3771 0121 612 3771 This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 SUPPORTING INFORMATION Licensed indications Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous behavioural syndrome characterised by the core symptoms of inattention, hyperactivity and impulsivity. ADHD should only be diagnosed by a specialist psychiatrist, paediatrician, or other healthcare professional with training and expertise in the diagnosis of ADHD. Diagnosis of ADHD should be made according to DSM-IV criteria or the guidelines in ICD-10 and should also be based on a complete history and evaluation of the patient, including a full clinical and psychosocial assessment, full developmental and psychiatric history, and assessment of mental state. Diagnosis cannot be made solely on the presence of one or more symptoms. Drug treatment is the first line treatment for adults with ADHD with either moderate or severe levels of impairment. Psychological interventions without medication may be effective for some adults with moderate impairment, but there are insufficient data to support this recommendation. If there is residual impairment despite some benefit from drug treatment or there is no response to drug treatment, CBT may be considered. There is the potential for drug misuse and diversion in adults with ADHD, especially in some settings such as prison, although there is no strong evidence that this is a significant problem. Methylphenidate is recommended for the treatment of ADHD in the UK by NICE. However, safety and efficacy have not been established for the initiation of treatment in adults or the routine continuation of treatment beyond 18 years of age. If treatment withdrawal has not been successful when an adolescent has reached 18 years of age continued treatment into adulthood may be necessary. The need for further treatment of these adults should be reviewed regularly and undertaken annually. Methylphenidate does not have a licence for use in adults, except for Matoride XL which can be used in patients who have reached 18 years of age and in whom it is deemed appropriate to continue treatment. In these circumstances, consider switching to Matoride XL. If methylphenidate is ineffective or unacceptable, atomoxetine or dexamphetamine may be considered and are subject to separate ESCAs. Atomoxetine and lisdexamphetamine are also licensed for use in adults, but only when the patient has had ADHD as a child and symptoms are continuing into adulthood. Pharmacotherapy should form part of a comprehensive treatment programme for ADHD that includes psychological, behavioural and educational advice and interventions. Therapeutic Use The aim of stimulant medication as part of a comprehensive treatment programme is to stabilise patients 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. METHYLPHENIDATE Dosage and Administration This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 The basic principle is to start with a low dose consistent with starting doses in the British National Formulary (BNF) and/or Summary of Product Characteristics (SPC) and titrate the dose against symptoms and side effects over 4–6 weeks. Dose reductions should be considered if side effects become troublesome. Dose titration should be slower if tics or seizures are present in people with ADHD. The dose should be increased according to response up to a maximum of 100 mg/day Modified-release preparations should usually be given once daily and no more than twice daily. Modified-release preparations may be preferred to increase adherence and in circumstances where there are concerns about substance misuse or diversion. Immediaterelease preparations should be given up to four times daily. There are currently four sustained release preparations available (Concerta XL, Equasym XL, Matoride XL and Medikinet XL) and three immediate-release preparations (Ritalin, Equasym and Medikinet). Ritalin and Medikinet: Initially 5mg 2-3 times daily (e.g. breakfast and lunch), increasing the dose and frequency of administration if necessary at weekly intervals of 5-10mg in the daily dose according to response, maximum 100mg daily in 2-3 divided doses. Medikinet XL: Start with 10mg every morning with/after breakfast and titrate gradually at weekly intervals according to response, maximum 100mg daily. Capsules are available in strengths of 5mg, 10mg, 20mg, 30mg and 40mg. Medikinet XL capsules may be swallowed whole, or the capsule may be opened and the capsule contents sprinkled onto a tablespoon of apple sauce or yoghurt, then swallowed immediately without chewing. Equasym XL: Start with 10mg every morning before breakfast and titrate gradually at weekly intervals according to response, maximum 100mg daily. Capsules are available in strengths of 10mg, 20mg and 30mg. Equasym XL capsules may be swallowed whole, or the capsule may be opened and the capsule contents sprinkled onto a tablespoon of apple sauce, then swallowed immediately without chewing. The capsules and capsule contents must not be crushed or chewed. Concerta XL: Start with 18mg every morning, with or without food, adjusted at weekly intervals according to response, max. 108mg daily. Matoride XL: Start at 18mg daily, as a single morning dose. The dose is then adjusted at weekly intervals if necessary up to a maximum of 54mg daily. Contraindications Uncontrolled bipolar disorder, hyperthyroidism, cardiovascular disease (including heart failure, cardiomyopathy, severe hypertension, arrhythmias), structural cardiac abnormalities, phaeochromocytoma, vasculitis, cerebrovascular disorders, anorexia nervosa, psychosis, severe depression, suicidal ideation. Cautions Drug or alcohol dependence, epilepsy, anxiety or agitation, tics or a family history of Tourette syndrome. This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 Side-effects The most common side effects are insomnia, nervousness and headache. For a full list of side-effects refer to the current BNF or SPC. Drug Interactions Methylphenidate may inhibit the metabolism of coumarin anti-coagulants, anticonvulsants (e.g. Phenobarbital, Phenytoin, Primidone) and some antidepressants (tricyclic and selective serotonin reuptake inhibitors). Methylphenidate may also interact with anti-hypertensive drugs, drugs that elevate blood pressure, alcohol, centrally acting alpha-2 agonists and dopaminergic drugs. Refer to the current edition of the BNF or SPC for a full list of contraindications, cautions, side-effects and interactions. Monitoring Prior to prescribing, a baseline evaluation of the patients’ cardiovascular status including blood pressure and heart rate should be conducted. A comprehensive history of the patient should be taken, and pre-treatment height and weight should be recorded. For people taking methylphenidate routine blood tests and ECGs are not recommended unless there is a clinical indication. In adults the weight requires monitoring initially 3 and 6 months after drug treatment and those who require long-term methylphenidate therapy, weight should be recorded at least every 6 months. Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months. For people taking methylphenidate, who have sustained resting tachycardia, arrhythmia or systolic blood pressure greater than the 95th percentile (or a clinically significant increase) measured on two occasions should have their dose reduced and be referred to adult physician Development of new or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every 6 months and at every visit. If psychotic symptoms (for example, delusions and hallucinations) emerge after starting methylphenidate the drug should be withdrawn and a full psychiatric assessment carried out. Atomoxetine should be considered as an alternative. Anxiety symptoms, including panic, may be precipitated by stimulants, particularly in adults with a history of coexisting anxiety. Where this is an issue, lower doses of the stimulant and/or combined treatment with an antidepressant used to treat anxiety can be used; switching to Atomoxetine may be effective. If seizures are exacerbated in a person with epilepsy, or de novo seizures emerge following the introduction of methylphenidate the drug should be discontinued immediately. Dexamphetamine may be considered as an alternative in consultation with a regional tertiary specialist treatment centre. If tics emerge in people taking methylphenidate healthcare professionals should consider whether the tics are stimulant-related (tics naturally wax and wane), tic-related impairment This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 outweighs the benefits of ADHD treatment. If tics are stimulant-related, reduce the dose of methylphenidate or consider changing to Atomoxetine, or stop drug treatment. The patient’s response to medication should be assessed by the specialist at each review; and the question of whether to continue or stop medication should be addressed. Following an adequate response, drug treatment for ADHD should be continued for as long as it is clinically effective. This should be reviewed annually. For full details of the licensed indications, dosage and administration, cautions, contraindications, side effects, drug interactions and monitoring, refer to the current edition of the BNF, BNFc and SPC. Methylphenidate is a schedule 2 controlled drug; therefore all controlled drug prescription writing legislation set down in the section of ‘Controlled Drugs and Drug dependence’ in the BNF applies. References British National Formulary. No 68. BMJ Group/Royal Pharmaceutical Society of Great Britain. September 2014 – March 2015. Summary of Product Characteristics (SPC) for Concerta XL prolonged release tablets. June 2015. SPC for Equasym XL capsules. March 2014. SPC for Medikinet tablets. August 2015. SPC for Medikinet XL capsules. September 2015. SPC for Ritalin tablets. May 2015. SPC for Matoride Prolonged-release Tablets. February 2015 National Institute for Health and Clinical Excellence. Clinical Guideline 72. Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults. September 2008. Taylor D, Paton C, Kapur S. The Maudsley Prescribing Guidelines in Psychiatry. 12th edition. The South London and Maudsley NHS Foundation Trust, Oxleas NHS Foundation Trust. 2015. Version Control Version Date of Approval 1.0 2015 Author/s Tim Kingscote-Davies Dr Susan Varghese This ESCA has been approved for use by: BCPFT Medicines Dr S Edwards Management Committee Wolverhampton City CCG Prescribing Lead Brief Description of Changes New ESCA Signature Date Dr Parkes Sandwell & West Birmingham This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017 CCG Prescribing Lead Dudley CCG Prescribing Lead This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for methylphenidate Date approved: October 2015 Expiry date: October 2017