Methylphenidate in Children SCP

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SCP
4
SHARED CARE PROTOCOL
Methylphenidate
Clinical Indication: Attention Deficit Hyperactivity Disorder (ADHD)
in children (aged 6 to 18 )
Version 1: Oct 2014
due for review: Nov 2016
Introduction
Attention-Deficit Hyperactivity Disorder (ADHD) is diagnosed if the three clinical features -inattention,
over-activity and impulsiveness - have been present from an early age, persist in more than one
situation (e.g. at home and in school) and impair function. The diagnosis must be made following a
comprehensive assessment by an appropriate child psychiatrist and/or a paediatrician with special
interest and training in this field. The assessment and management of this condition has been reviewed
by SIGN Guideline No. 112, October 2009 and NICE Quality Standard 39, July 2013, Drug therapy with
Methylphenidate is only one part of the package of care for children with ADHD, which includes
behavioural and educational interventions.
Shared Care
A shared care protocol is used to facilitate the sharing of care and transfer of prescribing. This would
usually take place once the patient’s condition is stable; the patient is demonstrably benefiting from the
treatment and is free from any significant side effects. GPs should only take on the prescribing when
they are confident in the use of the drug, in the context of the protocol. Contingency plans must be in
place to enable the patient to receive the recommended treatment, should the GP decline to prescribe.
Indication for Therapy
Methylphenidate (Ritalin®/ Medikinet® /Equasym XL®/Concerta XL®/ Medikinet XL®) is licensed as part of
a comprehensive treatment programme for ADHD when remedial measures alone prove insufficient.
Treatment must be initiated under the supervision of a child psychiatrist and/or a paediatrician with
special interest and training in this field. The drug is not licensed for children less than six years of age,
as a result, this shared care protocol applies to children 6 years old and above, until care is transferred
from Paediatric and Young Persons Services to Adult Psychiatric Services.
Preparations Available
Methylphenidate is available in the following formulations:
Ritalin® - 10mg scored tablet (30 tablet pack)
Medikinet® - 5mg, 10mg and 20mg scored tablet (30 tablet pack)
Concerta XL® - 18mg, 27mg and 36mg modified release capsule (30 capsule pack)
Equasym XL® - 10mg, 20mg and 30mg modified release capsule (30 capsule pack)
Medikinet XL® - 5mg, 10mg, 20mg, 30mg and 40mg modified release capsule (28 capsule pack)
Methylphenidate preparations can be obtained from the wholesaler by a community pharmacist. It is
controlled by the Misuse of Drugs Act 1971 and is therefore subject to the regulations for controlled
drugs in relation to the requirements for safe custody and stating the quantity to be dispensed in both
words and figures. From June 2006 prescriptions for Controlled Drugs must be dispensed within 28
days of the date on the prescription.
Recommended Dosage and Administration
Doses are started at 5mg once or twice daily or for children over 6 years can be initiated on equivalent
dose of longer acting preparation and increased by the psychiatrist/paediatrician. If improvement is not
observed after appropriate dosage adjustment the drug will be discontinued. The
maximum recommended dose for methylphenidate is 60mg daily (in 2 or 3 divided doses). In some
children a rebound hyperactivity may occur as the effect of the drug wears off in the evening. Dividing
the doses to include a small evening dose of immediate release preparation may eliminate this difficulty.
Modified release preparations
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Concerta XL® may be used once daily in the morning, as indicated above, swallowed whole, CANNOT
be chewed, opened, divided or crushed. Patients can be converted from standard methylphenidate
preparations as described in the Summary of Product Characteristics. The dosage can be adjusted in
9mg increments from an initial 18mg to a maximum of 54mg once daily in the morning.
Equasym XL® should be given once daily in the morning before breakfast. Patients can be converted
from standard methylphenidate preparations as described in the Summary of Product Characteristics.
The dosage can be adjusted in 10mg increments to a maximum of 60mg daily.
Medikinet XL® should be given once daily in the morning with or after breakfast. Patients can be
converted from standard methylphenidate preparations as described in the Summary of Product
Characteristics. The dosage can be adjusted according to response to a maximum of 60mg daily.
Both Equasym XL® and Medikinet XL® capsules may be swallowed whole with the aid of liquids and
must NOT be chewed or crushed. Alternatively, the capsule may be opened and the capsule contents
sprinkled onto a small amount (tablespoon) of apple sauce and given immediately.
Shared Care Responsibilities
Aspects of Care for which the Specialist is responsible
Assessment and diagnosis of children with ADHD
 Before treatment, screen all for problems with blood pressure or heart rate and take a family history of
cardiac and cardiovascular disease. An ECG may be required.
 To prescribe the first dose during the initiation of trial
Liaison with GP to agree to share the patient’s care
 Making suitable arrangements with the patient in the event the practice are not willing to
prescribe.
Patient monitoring - initially 3 monthly, then 6 monthly in the longer term. This includes height, weight
and blood pressure and pulse.
Discontinuation - advising GP when Methylphenidate should be discontinued for patients receiving the
drug long term. The specialist will provide necessary supervision and support during the drug
discontinuation phase
Continuing supply of Methylphenidate for children under 6 years old.
If Methylphenidate is continued beyond 17 years then care should be transferred from CAMHS to
Adult Psychiatric Services as appropriate
Communication to ensure GP is informed of any changes in treatment e.g. patient monitoring, dose
alteration etc
Aspects of Care for which the General Practitioner is responsible
 To prescribe the drug if willing to do so under the instruction from the Specialist

If unwilling to prescribe the drug, to ask if any colleagues are willing to prescribe. If the
practice is unwilling to prescribe to relay this decision back to the Specialist in a timely
manner for alternative arrangements to be established.

Liaison with the Paediatrician/Psychiatrists regarding any complications of treatment
 Reporting of adverse reactions to Yellow Card Scotland is the responsibility of both the Consultant
and GP
 https://yellowcard.mhra.gov.uk/
Adverse Effects
The following have been reported:
Insomnia, nervousness (>10%)
Decreased appetite.
Occasional abdominal pain, nausea and vomiting (alleviated with concomitant food intake).
Headaches, arthralgia.
Emotional lability.
Temporary growth retardation may occur during prolonged therapy - monitor height and weight.
Changes in blood pressure and heart rate (usually increased).
Drug Interactions
 Warfarin- may increase the anticoagulant effect
 Anticonvulsants- phenytoin and phenobarbitone levels
may be increased
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


Tricyclic antidepressants- plasma levels may be
Increased
Alcohol- can increase CNS effects of methylphenidate
No known interactions with antibiotics, simple analgesics and antihistamines commonly
prescribed for children
Contra-Indications
Contra-indicated in patients with marked anxiety disorders, psychosis, cardiovascular disease
(including hypertension), hyperthyroidism, glaucoma, and in pregnancy (especially during first
trimester)
Contra-indicated in Tourette’s syndrome but is used with caution by specialists. Any prescribing
in this situation would be unlicensed.
Hypersensitivity or intolerance to methylphenidate or excipients.

Concerta XL® should not be used in patients with severe gastrointestinal tract narrowing or
dysphagia or significant difficulty with swallowing tablets
Precautions
 Patients with a history of epilepsy and in patients with a tic disorder.
Medication in methylphenidate m/r (Concerta XL®) is contained within a non-deformable,
nonabsorbable shell which is eliminated unchanged from the body in the patient’s stool.
Contact Points
Borders CAMHS
Primary Care Prescribing Team
BGH Pharmacy
Dr Diana Leaver, Community Paediatrician
West Lothian ADHD Service
Tel: 01750 23715
Tel: 01896 827708
Tel: 01896 826783
Tel: 01896 826686
Tel: 01506 419666 ext 2734
This information was prepared by the Consultants in the Department of Child and Adolescent Mental Health Service and the Pharmacists at the Royal
Edinburgh Hospital through liaison with the General Practice Prescribing Committee, the Paediatric & Neonatal Drug and Therapeutics Committee, Lothian
University Hospitals Division, and the Hospital and Specialist Services Medicines Committee, NHS Lothian. Used and adapted with permission.
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