Shared Care Guideline: Prescribing Agreement
Methylphenidate, Dexamfetamine and Atomoxetine for
Attention Deficit Hyperactivity Disorder in patients 6-18 years of age
Section A: To be completed by the hospital consultant initiating the treatment
GP Practice Details:
Name:
Address:
Tel no:
Fax no:
NHS.net e-mail:
Consultant name:
Clinic name:
Contact details:
Address:
Tel no
NHS.net e-mail:
Diagnosis:
Next hospital appointment:
Dear Dr.
,
Patient Details:
Name:
Address:
DOB:
/
/
Hospital number:
NHS number (10 digits):
Fax no:
Drug name & dose to be prescribed by GP:
/
/
Your patient was seen on
/
/
and I have started
.(insert drug name and dose) for the
above diagnosis. I am requesting your agreement to sharing the care of this patient from
/
/
in accordance with the attached Shared Care Prescribing Guideline (Title:
Methylphenidate, Dexamfetamine and Atomoxetine for Attention Deficit Hyperactivity Disorder in patients 6
- 18 years of age; Approval date:
/
/
). Please take particular note of Section 2 where the
areas of responsibilities for the consultant, GP and patient for this shared care arrangement are detailed.
Patient information has been given outlining potential aims and side effects of this treatment and
*
supplied (* insert any support materials issued such as patient held monitoring book etc where applicable).
The patient has given me consent to treatment possibly under a shared care prescribing agreement (with
your agreement) and has agreed to comply with instructions and follow up requirements.
The following investigations have been performed on
/
/
and are acceptable for shared
care. Please monitor
every
Test
Result
Test
Result
Blood pressure
Weight (incl centiles)
Pulse
Height (incl centiles)
Other relevant information:
Section B: To be completed by the GP and returned to the hospital consultant as
detailed in Section A above
Please sign and tick which applies (return your agreement within 14 days of receiving this request):
Tick which applies:
I accept sharing care as per shared care prescribing guideline and above instructions
I would like further information. Please contact me on:
I am not willing to undertake shared care for this patient for the following reason(s):
.
GP name:
GP signature:
………………………………………………Date:
/
/
.
1
South West London and St George’s Mental Health NHS Trust
working in partnership with
SHARED CARE PRESCRIBING GUIDELINE
Methylphenidate, Dexamfetamine and Atomoxetine for
Attention Deficit Hyperactivity Disorder in patients 6-18 years of age
NOTES to the GP
The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to
take clinical and legal responsibility for prescribing this drug.
The questions below will help you confirm this:
 Is the patient’s condition predictable or stable?
 Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as
indicated in this shared care prescribing guideline?
 Have you been provided with relevant clinical details including monitoring data?
If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for
you to accept prescribing responsibility. Prescribe only 28 days at a time with a review date of every 6 months.
If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write
to the consultant within 14 days, outlining your reasons for NOT prescribing. If you do not have the confidence to
prescribe, we suggest you discuss this with your local Trust/specialist service, who will be willing to provide
training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to
decline. Your CCG pharmacist will assist you in making decisions about shared care.
It would not normally be expected that a GP would decline to share prescribing on the basis of cost.
The patient’s best interests are always paramount
Date prepared: Sept 2013
Approved by (date approved):
SWLStG Drug & Therapeutic Committee: Sept 2013
Mental Health Interface Prescribing Forum: Sept 2013
Review date:
Sept 2015
This
Participating Clinical Commissioning Groups (CCG)
Kingston CCG
Dr Anthony Hughes, GP on behalf of Medicines
Management Committee
Seema Buckley, Chief Pharmacist
Richmond CCG
Dr Stavroula Lees, Lead GP for Mental Health
Emma Richmond, Head of Medicines Management
Merton CCG
Dr Andrew Otley, Mental Health Lead
Sedina Agama, Interim Chief Pharmacist
NHS Wandsworth
Dr Gillian Ostrowsky, Associate Medical Director
Nick Beavon, Chief Pharmacist
Sutton CCG
Dr Chris Keers, Mental Health Lead
Sarah Taylor, Interim Chief Pharmacist
Date approved: September 2013
Review date: September 2015
Participating Hospital Trusts
SWL & St. George’s Mental Health Trust
Dr M Zwi (CAMHS Consultant)
Dianne Adams (Chief Pharmacist)
2
SHARED CARE PRESCRIBING GUIDELINE
Methylphenidate, Dexamfetamine and Atomoxetine in under 18s
1.
CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE
 Prescribing responsibility will only be transferred when the Child and Adolescent Mental Health Service
(CAMHS) and the GP are in agreement that the patient’s condition is stable or predictable and in
accordance with NICE guidance.
 The patients will only be referred back to the GP once the GP has agreed in each individual case and
the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined
below
 The hospital will provide the patient with a minimum initial supply of 4 weeks of medication
2.
AREAS OF RESPONSIBILITY
CAMHS
1. To assess the patient and establish a diagnosis of attention-deficit
1.
hyperactivity disorder; to determine a management strategy and
communicate this to the family & GP. The diagnosis must clearly
2.
be demonstrated through a detailed report outlining the current
problems, developmental history and presence of “core signs” of
3.
ADHD. These must meet the diagnostic criteria of the DSM-IV or
the ICD-10 (hyperkinetic disorder).
2. Consider and discuss ADHD drug treatment options with the
parents / responsible adult for the children who meet the criteria
laid-down in NICE guidelines of September 2008. This should
include consideration of contra-indications, interactions and
cautions, a discussion of the reasons for treatment, the possible
4.
adverse effects and the lack of information in relation to longerterm outcomes including effectiveness and adverse effects.
3. Ensure relevant baseline investigations are performed,
5.
documenting height, weight and blood pressure and pulse and
additional relevant investigations (e.g. ECG if family history of
6.
arrhythmias or sudden death).
4. Initiate treatment with methylphenidate, dexamfetamine or
atomoxetine and prescribe medication until the dose has been
stabilised. During this time monitor the patient as required for
symptom control and side effects. Discontinue if no improvement
7.
of symptoms.
5. Provide the GP with appropriate clinical information and individual
patient information. This may need to be more comprehensive with
atomoxetine as GPs have much less experience and familiarity
with this medicine.
6. Be available to give advice to GP if the patient’s condition changes
and to ensure that procedures are in place for prompt specialist
review.
8.
7. Once ADHD symptoms have been reduced and the medication
has been stabilised (see 4 above), the patient will then be reviewed
at least annually. The review should include an assessment of
symptoms, benefit of treatment and review of possible side effects.
8. Discontinue treatment periodically (usually annually) and advise the 9.
GP accordingly. Provide supervision and assessment of the child
during these periods.
9. Liaise with the patient’s school and suggest appropriate extra
educational provision where necessary.
10. Where the drug is to be continued beyond the age of 18, the
10.
consultant will advise about the options for ongoing care within
adult services for each patient’s particular needs.
Patient/ carer’s role
1. Attend follow up appointments with Consultant (at least annually)
2. Attend for tests and follow up appointments with GP (at least 6 monthly)
3. Keep medication safe and for personal use only
Date approved: September 2013
Review date: September 2015
GP
Monitor patient’s overall health and
well being.
Review the patient in accordance with
specialist advice.
Prescribe methylphenidate,
dexamfetamine or atomoxetine once
the treatment has been established,
the patient stabilised on a particular
dose and brand of medication and the
care of patient has been transferred
and accepted.
Monitor height, weight and blood
pressure and pulse six monthly. Notify
the specialist of any concerns.
Advise the patient to attend specialist
appointments (at least annually).
Re-refer the patient or seek specialist
advice from the psychiatrist or
paediatrician if there is deterioration in
ADHD symptomatology, behaviour, or
adverse effects of medication.
Although misuse of methylphenidate
and dexamfetamine is rare, the GP
should alert the Specialist to previous
misuse of drugs by the young person
or family members if such information
is known. This is particularly important
because methylphenidate and
dexamfetamine are controlled drugs.
Observe for potential liver toxicity with
atomoxetine, signs include abdominal
pain,unexplained nausea, and
malaise, darkening of urine or
jaundice.
To report any adverse drug reactions
to the Medicines and Healthcare
Products Regulatory Authority
(MHRA) as part of the yellow card
scheme.
Refer back to consultant if patient
becomes pregnant.
3
SHARED CARE PRESCRIBING GUIDELINE
3.
COMMUNICATION AND SUPPORT
Hospital contacts:
Out of hours contacts & procedures:
(the referral letter will indicate named consultant)
Enter the contact details of your local
Out of hours contacts & procedures:
CAMHS
Psychiatrist & Pharmacist available via the
Hospital Switchboard 020 3513 5000
Clinic/Hospital name
Consultant names
Tel:
Fax:
E-mail:
1. Contact with CAMHS
2. BMJ patient information found by at besthealth.bmj.com
3. Information in the British National Formulary for Children (BNFc)
4. ADHD support groups e.g. http://www.adders.org or http://www.addiss.co.uk (both of whom receive
sponsorship from the pharmaceutical industry)
5. SWLSTG Psychiatric Medicines Information 020 3513 6829.
4.
CLINICAL INFORMATION
Indication(s)
Place in therapy
Therapeutic
summary
Duration of
treatment
Attention-deficit hyperactivity disorder (which is broadly similar to hyperkinetic disorder)
is defined by core signs of an excess of inattention, hyperactivity and impulsiveness.
These are normal personality traits, so is important to establish that they are present to
a greater extent than expected in children of a developmental stage, that they cause
impairment (commonly in social or academic domains) and that they are pervasive
across a range of situations.
Affected children often have co-morbid conditions including conduct disorder,
oppositional defiant disorder, depression, anxiety, tic disorders and other developmental
disorders.
Methylphenidate (instant release and long acting Concerta XL®, Equasym XL® and
Medikinet XL®).
The management of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 6
years and over and in adolescents.
Dexamfetamine
Refractory hyperkinetic states, or if methylphenidate fails.
Atomoxetine
First or second line management of Attention Deficit/Hyperactivity
Disorder (ADHD) in children aged 6 years and over and in adolescents.
Please note: Methylphenidate is the usual preferred drug of choice, however some
patients may require an alternative drug according to individual need.
Methylphenidate, dexamfetamine and atomoxetine reduce the ADHD “core symptoms”:
excessive inattention, hyperactivity and impulsivity.
o Determined on an individual basis. Discontinue treatment periodically (usually
annually), or if no improvement.
o Transition to adult psychiatric services to be managed on an individual case basis
as currently the numbers are very few, but increasing.
Date approved: September 2013
Review date: September 2015
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SHARED CARE PRESCRIBING GUIDELINE
Dose and Route
of Administration
All preparations are for oral administration.
Dosage and timing will depend upon the patient and the form of the medicine:
Methylphenidate
Standard / Immediate release preparations
Ritalin® 10mg tablets & Medikinet® 5mg, 10mg, 20mg
o Initiate at 5mg OD or BD; increase dosage if necessary weekly, by increments of 510mg per day
o Usual maximum dosage 60mg per day in divided doses (usually at intervals of 3-4
hours)
Modified release preparations
Concerta-XL® 18mg, 27mg, 36mg MR tablets
o Initiate at 18mg daily; increase dose gradually according to needs and response of
the patient.
o Usually up to 54mg per day (max 108mg daily unlicensed).
Equasym XL® 10mg, 20mg, 30mg MR capsules
o Initiate at 10 mg once daily in the morning before breakfast, increased gradually if
necessary
o Usually up to 60 mg daily (max 90mg daily unlicensed).
Medikinet XL® 10mg, 20mg, 30mg, 40mg MR tablets
o Initiate at 10 mg once daily in the morning before breakfast, increased gradually if
necessary
o Usually up to 60 mg daily (max 90mg daily unlicensed).
Dosage equivalence (immediate release (IR) vs. modified release (MR)):
5mg TDS (IR) = 18mg OD Concerta XL®
10mg TDS (IR) = 36mg OD Concerta XL®
15mg TDS (IR) = 54mg OD Concerta XL®
5mg BD (IR) = 10mg Equasym XL®
10mg BD (IR) = 20mg Equasym XL®
15mg BD (IR) = 30mg Equasym XL®
Dexamfetamine
Dexedrine® 5mg tablets (standard release)
o Initiate at 5–10 mg daily for children over 6yrs.
o Increase dose to a usual maximum of 20 mg per day as necessary (in divided
doses usually 2-3 times daily). May require 40 mg or more daily in older children /
adolescents.
Atomoxetine
Strattera® 10mg, 18mg, 25mg, 40mg, 60mg, 80mg capsules
o patients up to 70 kg body weight: initiate at a total daily dose of approximately
0.5mg/kg. Increase the dose gradually as required to recommended maintenance
dose of approx. 1.2mg/kg/day.
o patients over 70 kg body weight: initiate at a total daily dose of 40mg. Increase the
dose gradually as required to recommended maintenance dose of 80mg.
Date approved: September 2013
Review date: September 2015
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SHARED CARE PRESCRIBING GUIDELINE
Summary of
adverse effects
Adverse effect
Consult Summary of
Product Characteristics
(SmPC) for a full list.
Methylphenidate
Dexamphetamine
Frequency
Nervousness and insomnia
>10%
Review dose and/or omit afternoon or
evening dose if using three times daily
Abdominal pain, nausea and
vomiting
Athralgia, nasopharyngitis, cough
or pharyngolaryngeal pain.
Moderately reduced weight and
slight growth retardation during
prolonged use
Increased pulse and blood
pressure
1-10%
Administer with food
1-10%
Review is persistent or troublesome.
0.01-0.1%
Discontinue if significant weight loss or
growth retardation.
1-10%
Use with caution in patients with
underlying cardiovascular medical.
Discontinue if significant hypertension.
Headache
1-10%
Drowsiness/dizziness
1-10%
Tachycardia
/palpitations/arrythmias
Decreased appetite
Dry mouth
1-10%
Refer back to psychiatric team if
persistent or troublesome.
Refer back to psychiatric team if
persistent or troublesome.
Discontinue if significant
Rash, pruritis
1-10%
Leucopenia, thrombocytopenia,
anaemia
Convulsions
<0.01%
Suicide attempt
Neuroleptic Malignant Syndrome
(Fever, diaphoresis, rigidity,
confusion. Elevated: CK,
leukocytosis & LFTs. Fluctuating:
consciousness, BP & tachycardia.
Sudden death
<0.01%
<0.01
Insomnia, restlessness,
irritability, euphoria, tremor,
dizziness, headache and
other symptoms of overstimulation
have been
reported.
Dry mouth, unwanted
anorexia, other GI
symptoms, sweating, convulsions
and cardiovascular effects such
as tachycardia, palpitations and
minor increases in blood pressure.
Sudden death
1-10%
1-10%
<0.01%
0.01%
Nausea, vomiting or abdo pain
Date approved: September 2013
Review date: September 2015
Usually transient
Refer back to psychiatric team if
persistent or troublesome.
Refer back to psychiatric team if
persistent or troublesome.
Check FBC if recurrent nose bleeds,
bruising or recurrent infections.
Discontinue if increase in frequency and
discuss with psychiatric team.
Discuss with psychiatric team.
Unsure if NMS if due to methylphenidate.
Maybe related to other medicines.
Discontinue if signs appear.
Prevention. See ‘areas of responsibility’
and references.
Reduce dose, ensure not
given too near to bed time.
Medication review by CAMHS.
Refer back to psychiatric team if
persistent or troublesome.
Not stated
Prevention. See ‘areas of responsibility’
and references.
Reduced height and weight gain
Neuroleptic Malignant Syndrome
(Fever, diaphoresis, rigidity,
confusion. Elevated: CK,
leukocytosis & LFTs. Fluctuating:
consciousness, BP & tachycardia)
Atomoxetine
Management
Stop and urgently refer to A&E.
>10%
Usually settles in the first month of
therapy.
6
SHARED CARE PRESCRIBING GUIDELINE
Insomnia
>10%
Dysuria, urinary retention
Visual disturbances e.g. mydriasis
1-10%
0.1-1%
Cardiac disorders such as
arrhythmias, tachycardia,
palpitation
Allergic reactions: rash,
angioneurotic oedema,
urticaria.
Modest increase in BP
1-10%
Usually settles in the first month of
therapy.
Refer to psychiatric team.
Stop if persistent and refer to psychiatric
team.
Stop, refer to psychiatric team
0.1-1%
Discontinue therapy and treat clinically.
Liver toxicity
Suicide related events and
suicidal ideation
Weight loss
Sudden death
Monitoring
Requirements:
Clinically relevant
drug interactions:
(See Summary of
Product Characteristics
(SmPC) for a full list)
Monitor, but
not usually
clinically
important.
<0.01%
0.1-1%
<0.01%
Case reports
Monitor, review and discontinue
therapy if clinically
Indicated.
Discontinue therapy.
0.44% of patients on atomoxetine
Compared with none on placebo.
Discontinue if signs appear and monitor.
Usually settles after initial weight loss
Increased risk in patients with preexisting structural cardiac abnormalities
or other serious heart problem.
Prevention: See ‘areas of responsibility’
and references.
o
o
o
Blood pressure & pulse every 6 months
Height & weight annually or sooner if clinically indicated
No routine measurement of LFTs / FBC, but measure if signs of liver impairment
(seen with atomoxetine).
o In line with other shared care documents, see ‘areas of responsibility’
In practice, very few children are taking other regular medicines.
 Stimulant drugs may exacerbate effects of sympathomimetic drugs and coumarins,
inhibit the metabolism of SSRIs and tricyclics, increase plasma concentration of
antiepileptics and increase risk of hypertension when volatile liquid anaesthetic
gases are used and diminish the effects of antihypertensive medicines.
 Stimulants should not be prescribed with MAOIs, a two week washout is required
when switching to either medicine.
 Caution if atomoxetine is used with medicines that may decrease seizure threshold
(e.g. antidepressants & antipsychotics), increase QT interval (e.g. antipsychotics or
macrolides), or inhibit CYP2D6 (e.g. fluoxetine, paroxetine, quinidine or terbinafine)
 Stimulants combined with alcohol may exacerbate adverse CNS effect. Patients
should be advised to abstain from alcohol during treatment.
 Dexamphetamine may increase the risk of cardiovascular effects of TCAs and
increase the analgesic effect of opiates and decrease the respirator depressant
effects.
Date approved: September 2013
Review date: September 2015
7
SHARED CARE PRESCRIBING GUIDELINE
Practical issues:
Key references:
 Methylphenidate and dexamfetamine are schedule 2 controlled
drugs, full controlled drug prescribing requirements apply when prescribing.
 DoH recommends a maximum of 30 days’ supply for schedule 2
 drugs.
 Stimulant medicines can be abused. As such, the prescriber must bear in mind any
factors relating to the child or other family members that may be of concern in this
regard.
 Modified release preparations of methylphenidate must be prescribed by brand as
they are not interchangeable.
 Immediate release methylphenidate (Ritalin® & Medikinet®) tablets can be halved.
 Concerta XL®: Tablets must be swallowed whole, not chewed, crushed or broken.
The tablet shell is eliminated from the body; children/adolescents and carers should
be advised not to be concerned if they occasionally notice something that looks like a
tablet in their stools.
 Equasym XL® and Medikinet XL®: Capsules may be opened and contents mixed with
soft fods (stability unknown). Contents must be swallowed whole, not chewed or
broken.
 Medikinet XL® or Equasym XL® ingested with high fat content food delays absorption
by approximately 1.5 hours.
 Atomoxetine is an ocular irritant and capsules are not intended to be opened. In the
event of capsule content coming in contact with the eye, the affected eye should be
flushed immediately with water.
 NICE Clinical Guideline – CG72. September 2008.
Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in
children, young people and adults.
http://publications.nice.org.uk/attention-deficit-hyperactivity-disorder-cg72
 NICE Quality Standard – QS39. July 2013.
Attention deficit hyperactivity disorder
http://publications.nice.org.uk/attention-deficit-hyperactivity-disorder-qs39
 NICE Technology Appraisal - TA98. March 2006.
Methylphenidate, atomoxetine and dexamphetamine for attention deficit
hyperactivity disorder (ADHD) in children and adolescents.
http://publications.nice.org.uk/methylphenidate-atomoxetine-and-dexamfetaminefor-attention-deficit-hyperactivity-disorder-adhd-ta98
 British National Formulary for Children (accessed 28 August 2013)
http://www.bnf.org/bnf/
 Drug and Safety Update, Medicines and Healthcare Regulatory Agency website
(accessed 28 August 2013)
http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON04121
1
 Am J Psychiatry 166:9, September 2009 Editorial: Stimulant Treatment of ADHD and
Risk of Sudden Death in Children
 Gould MS et al Am J Psychiatry 2009; 166:992-1001 Sudden Death and use of
Stimulant Medications in Youths
 Summaries of Product Characteristics (accessed 28 August 2013)
 Ritalin® (last updated on eMC: 10/06/2013)
 Medikinet® (last updated on eMC: 21/12/2011)
 Concerta XL® (last updated on eMC: 18/02/2013)
 Equasym XL® (last updated on eMC: 11/10/2011)
 Medikinet XL® (last updated on eMC: 21/12/2011)
 Strattera® (last updated on eMC: 28/05/2013)
http://www.medicines.org.uk/emc/
 Summary of Product Characteristics (accessed 28 August 2013)

Dexedrine® (last updated: March 2010)
http://www.adhd-institute.com/media/108084/dexedrine-spc.pdf
Date approved: September 2013
Review date: September 2015
8