Download Methylphenidate - Wolverhampton Formulary

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
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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