Shared Care Guideline: Prescribing Agreement
Methylphenidate, Dexamfetamine and Atomoxetine for
Attention Deficit Hyperactivity Disorder in Adults >18 years of age
Section A: To be completed by the hospital consultant initiating the treatment
GP Practice Details:
Patient Details:
Name: ………………………………………
Name: ………………………………………………
Address: ……………………………………
Address: ……………………………………………
Tel no: ………………………………………
DOB: ……/………/…………
Fax no: ………………………………………
Hospital number: …………………………………
Email: ……………………………………….
NHS number (10 digits): …………………………
Consultant name: ……………………………
Clinic name: ………………………………….
Contact details:
Address: ..........................................................................................................................
Tel no: ……………………………………… Fax no: ………………………………………
Email: ……………………………………….
Diagnosis:
Drug name & dose to be prescribed by GP:
……………………………………………………
…………………………………………………………….
Next hospital appointment: ……/……/……..
Dear Dr. ……………………..,
Your patient was seen on …../..…/………and I have started …………………………………………….(insert
drug name and dose) for the above diagnosis and are stabilised on this treatment. 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 Adults >18 years of age; Approval date: …./…./……..). Please take particular
note of Section 2 where the areas of responsibility 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 (inc BMI)
Pulse
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 return your agreement to shared care 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:
……………………………………………………………………………………………………………….
GP name: ………………………………………….……….
GP signature: ………………………………………………Date: …/…/…..
1
SHARED CARE PRESCRIBING GUIDELINE
Methylphenidate, Dexamfetamine and Atomoxetine for
Attention Deficit Hyperactivity Disorder in Adults >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.
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 PCT 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: December 2012
Approved by (date approved):
Mental Health Interface Prescribing Forum. Jan
2013.
South West London & St Georges NHS Trust Drug &
Therapeutics Committee February 2013.
Next Review date: February 2014
Prepared by:
Dr Morris Zwi, CAMHS Consultant
Dr David Li, Consultant Psychiatrist
Kyra Sycamore, Lead Pharmacist, SWLStG
Participating Primary Care Trusts
NHS Richmond
Dr Darren Tymens, Medical Director
Emma Richmond, Chief Pharmacist
Participating Hospital Trusts
SWL & St. George’s Mental Health Trust
Dr Emma Whicher, Medical Director
Dianne Adams, Chief Pharmacist
Date prepared: December 2012
Date approved:
Review date: December 2014
2
SHARED CARE PRESCRIBING GUIDELINE
Methylphenidate, Dexamfetamine and Atomoxetine in Adults
1.
CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE
 Prescribing responsibility will only be transferred when the Adult ADHD Service and the GP are in
agreement that the patient’s condition is stable or predictable and in accordance with NICE guidance.
 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 is completed,
as outlined below.
 The hospital will provide the patient with a minimum initial supply of 12 weeks of medication on
initiation.
2.
AREAS OF RESPONSIBILITY
ADULT ADHD SERVICE
GP
1. To assess the patient and establish a diagnosis of attention1. Monitor the patient’s overall health and
deficit hyperactivity disorder; to determine a management
well being.
strategy and communicate this to the patient & GP. The
2. Review the patient in accordance with
diagnosis must clearly be demonstrated through a detailed
specialist advice
report outlining the current problems, developmental history
3. Prescribe methylphenidate,
and presence of “core signs” of ADHD. These must meet the
dexamfetamine or atomoxetine once the
diagnostic criteria of the DSM-IV or the ICD-10 (hyperkinetic
treatment has been established, the
disorder).
patient stabilised on a particular dose and
2. Consider and discuss ADHD drug treatment options with
brand of medication, and the care of the
patients who meet the criteria laid-down in the NICE
patient has been transferred and accepted.
guidelines for ADHD (September 2008). This should include
4. Monitor weight, blood pressure and pulse
consideration of contra-indications, interactions and cautions,
should be undertaken as per NICE
a discussion of the reasons for treatment, the possible
guidance (weight: at 3m, 6m then 6
adverse effects and the lack of information in relation to
monthly, heart rate and BP: after every
longer-term outcomes including effectiveness and adverse
dose change and 3 monthly). Send
effects.
copies of the results to the specialist.
3. Discuss any unlicensed prescribing of medication with the
Notify the specialist of any concerns.
patient and obtain consent.
5. Check that the patient is attending
4. Ensure relevant baseline investigations are performed,
arranged specialist appointments (at least
documenting weight, blood pressure, pulse and any
annually).
additional relevant investigations (e.g. ECG if family history of 6. Re-refer the patient or seek specialist
arrhythmias or sudden death).
advice from the psychiatrist if there is
5. Initiate treatment with methylphenidate (1st line),
deterioration in ADHD symptomatology,
dexamfetamine or atomoxetine and prescribe medication until
behaviour, or adverse effects of
the dose has been stabilised (usually 4 weeks). During this
medication.
time monitor the patient as required for symptom control and
7. Although misuse of methylphenidate and
side effects. Discontinue if no improvement of symptoms.
dexamfetamine is rare, the GP should alert
6. Provide the GP with appropriate clinical information and
the specialist to previous misuse of drugs
individual patient information. This may need to be more
by the patient if such information is known.
comprehensive with atomoxetine as GPs have much less
This is particularly important because
experience and familiarity with this medicine.
methylphenidate and dexamfetamine are
7. Be available to give advice to GP if the patient’s condition
controlled drugs.
changes and to ensure that procedures are in place for
8. Observe for potential liver toxicity with
prompt specialist review.
atomoxetine, signs include abdominal
8. Once ADHD symptoms have been reduced and the
pain,unexplained nausea, and malaise,
medication has been stabilised (see 2 above), the patient will
darkening of urine or jaundice.
then be reviewed at least annually. The review should include 9. To report any adverse drug reactions to
an assessment of symptoms, benefit of treatment and review
the Medicines and Healthcare Products
of possible side effects.
Regulatory Authority (MHRA) as part of the
9. Discontinue treatment periodically (usually annually) and
yellow card scheme.
advise the GP accordingly. Provide supervision and
10. Refer back to consultant if patient
assessment of the patient during these periods.
becomes pregnant.
10. To accept referrals of patients prescribed medicines to treat
ADHD who become pregnant.
Patient’s role
1. Attend follow up appointments with Consultant (at least annually)
2. Attend for tests and follow up appointments with GP (at least 3 monthly) and report side effects.
3. Keep medication safe and for personal use only (some are controlled drugs).
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
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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
Adult ADHD Service
The on-call Psychiatrist and Pharmacist can be
contacted via the hospital switchboard: 020 3513 5000.
Tel:
Fax:
Email:
Specialist support/resources available to GP including patient information:
1. Contact with Adult ADHD Service
2. Medicines Information Website www.choiceandmedication.org/swlstg-tr
3. Mental Health Medicines Information Helpline - 0203 513 6829
4. Information in the British National Formulary (BNF)
5. Summary of Product Characteristics www.emc.medicines.org.uk
6. NICE Guidelines – ADHD (September 2008). www.nice.org.uk
7. ADHD support groups e.g. http://www.adders.org or http://www.addiss.co.uk (both of whom receive
sponsorship from the pharmaceutical industry)
4.
CLINICAL INFORMATION
Indication(s)
Place in therapy
Therapeutic
summary
Duration of
treatment
-
Attention-deficit hyperactivity disorder is defined by core signs of an excess of
inattention, hyperactivity and impulsiveness. These are normal personality traits, so it
is important to establish that they are present to a greater extent than would normally
be expected, that they cause impairment (commonly in social or academic domains)
and that they are pervasive across a range of situations.
NICE clinical guidelines for the Management of ADHD state that the treatment
strategies for ADHD in adults are essentially similar to those used in childhood. It
also very importantly states that “it remains an anomaly that many drugs that are
considered to be safe and effective in children and adolescents are not licensed for
use in adults”.
Drug treatment should be the first line treatment for ADHD, unless the person prefers
psychological treatment. Medication should be prescribed as part of a
comprehensive treatment programme addressing psychological, behavioural and
educational or occupational needs.
All products named in this document for the treatment of ADHD are currently
licensed for use in children. Historically, ADHD was considered a childhood disorder
and patients were expected to grow out of this condition by their late teens. However,
it is now widely recognised that in up to 70% - 80% of patients, the condition
continues into adulthood, and continues to cause impairment of functioning in a large
proportion of these patients.
BAP Guidelines state: “Although controlled evidence for prescribing in adults is not
extensive, this consensus statement can be considered to meet the criteria for
adequate evidence and experience when prescribing standard medications to adults
with ADHD, when done in the context or with support of specialist psychiatric
services”.
Concerta® and Atomoxetine are licensed for use in adults if initiated in adolescence.
Following a decision to start drug treatment in adults with ADHD:
Methylphenidate should normally be tried first
Atomoxetine or dexamfetamine should be considered if symptoms do not respond to
methylphenidate or if the person is intolerant to it after an adequate trial.
Atomoxetine should be considered as first-line treatment if there are concerns about
drug misuse and diversion. Exercise caution if prescribing dexamfetamine or
methylphenidate to people at risk of stimulant misuse or diversion. Modified release
preparations of methylphenidate are less likely to be misused than immediate
release preparations.
Methylphenidate, dexamfetamine and atomoxetine are effective in reducing the core
symptoms of ADHD, i.e. excessive inattention, hyperactivity and impulsivity.
Duration of treatment should be determined on an individual basis. Treatment should be
discontinued periodically (usually annually) to assess if it is still beneficial.
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
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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 medicine preparation:
Methylphenidate
Please note: brands are not interchangeable due to different release profiles
Standard / Immediate release preparations
Ritalin® 10mg tablets & Medikinet® 5mg, 10mg, 20mg
Initiate at low doses, e.g. 5mg TDS
Increase dosage (usually weekly) according to response, up to a maximum of 100mg
per day.
Prescribe in divided doses, up to four times a day.
Modified release preparations
Concerta-XL® 18mg, 27mg, 36mg MR tablets
Initiate at 18mg daily; increase dose gradually according to needs and response of
the patient, up to a maximum of 108mg per day.
Prescribe as a once daily dose (usually in the morning).
Equasym XL® 10mg, 20mg, 30mg MR capsules
Initiate at 10mg once daily in the morning before breakfast, increase gradually as
necessary, up to a maximum of 100mg per day.
Prescribe as a once daily dose.
Medikinet XL® 10mg, 20mg, 30mg, 40mg MR tablets
Initiate at 10 mg once daily in the morning before breakfast, increase gradually if
necessary, up to a maximum of 100mg per day.
Prescribe as a once daily dose.
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)
Initiate at a low dose of 5mg BD
Increase gradually according to response, up to a maximum of 60mg per day.
Prescribe in divided doses, usually 2-4 times daily
Atomoxetine
Strattera® 10mg, 18mg, 25mg, 40mg, 60mg, 80mg capsules
Patients up to 70 kg body weight:
Initiate at a total daily dose of approximately 0.5mg/kg.
Increase the dose after seven days to a recommended maintenance dose of approx.
1.2mg/kg/day.
Patients over 70 kg body weight:
Initiate at a total daily dose of 40mg/day
Increase the dose after seven days to a recommended maintenance dose of
100mg/day.
The usual maintenance dose is 80-100mg/day, usually in divided doses.
Review after 6 weeks to determine effectiveness.
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
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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
Nervousness, anxiety, insomnia
Abdominal pain, nausea and
vomiting
Athralgia, nasopharyngitis, cough
or pharyngolaryngeal pain.
Moderately reduced weight during
prolonged use
Increased pulse and blood
pressure
Headache
Drowsiness/dizziness
Tachycardia
Palpitations/ arrythmias/ syncope
Decreased appetite
Dry mouth
Rash, pruritis
Leucopenia, thrombocytopenia,
anaemia
Convulsions
Psychotic symptoms
(delusions, hallucinations)
Suicide attempt and ideation.
Neuroleptic Malignant Syndrome
(Fever, diaphoresis, rigidity,
confusion. Elevated: CK,
leukocytosis & LFTs. Fluctuating:
consciousness, BP & tachycardia.
Sudden death
Dexamphetamine
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
Weight gain
Neuroleptic Malignant Syndrome
(Fever, diaphoresis, rigidity,
confusion. Elevated: CK,
leukocytosis & LFTs. Fluctuating:
consciousness, BP & tachycardia)
Psychotic symptoms
(delusions, hallucinations)
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
Management
Review dose and/or omit afternoon or evening dose if
using three times daily. If persistent refer to psychiatric
team. Medication review. Consider atomoxetine.
Administer with food
Review if persistent or troublesome.
Discontinue if significant weight loss.
Use with caution in patients with underlying
cardiovascular medical.
Discontinue if significant hypertension.
Refer back to psychiatric team if persistent or
troublesome.
Refer back to psychiatric team if persistent or
troublesome.
Discontinue if significant.
Discontinue. Refer for cardiac evaluation.
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.
Discontinue. Refer to psychiatric team for full
assessment.
Discuss with psychiatric team.
Unclear if NMS is due to methylphenidate. Maybe related
to other medicines. Discontinue if signs appear.
Prevention. See ‘areas of responsibility’ and references.
Reduce dose, ensure not taken too near to bed time. If
persistent refer to psychiatric team for a medication
review. Consider atomoxetine.
Refer back to psychiatric team if persistent or
troublesome.
Prevention. See ‘areas of responsibility’ and references.
Stop and urgently refer to A&E.
Discontinue. Refer to psychiatric team for full
assessment.
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SHARED CARE PRESCRIBING GUIDELINE
Nausea, vomiting or abdominal
pain
Insomnia
Agitation, anxiety, irritability
(especially after dose changes)
Dysuria, urinary retention
Visual disturbances e.g. mydriasis
Cardiac disorders such as
arrhythmias, tachycardia,
palpitation
Allergic reactions: rash,
angioneurotic oedema,
urticaria.
Modest increase in BP
Atomoxetine
Liver damage – abdominal pain,
unexplained nausea, malaise,
darkening of urine, jaundice
Suicide related events and suicidal
ideation
Weight loss
Dysmenorrhoea, erectile
dysfunction, ejaculatory dysfunction
Sudden death
Monitoring
Requirements
:
-
Clinically
relevant drug
interactions:
(See Summary of
Product
Characteristics
(SmPC) for a full
list)
-
-
Practical
issues:
-
Usually settles in the first month of therapy.
(see “liver damage” below)
Usually settles in the first month of therapy.
If severe, stop therapy and refer to psychiatric team.
Refer to psychiatric team.
Stop if persistent and refer to psychiatric team.
Stop, refer to psychiatric team
Discontinue therapy and treat clinically.
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
Monitor. If persistent, refer to psychiatric team for review
of medication.
Increased risk in patients with pre-existing structural
cardiac abnormalities or other serious heart problem.
Prevention: See ‘areas of responsibility’ and references.
Blood pressure & pulse every 3 months, and before and after dose changes.
Weight 3m, 6m then 6 monthly, or sooner if clinically indicated.
Routine blood tests and ECG are not recommended unless clinically indicated, e.g. if
signs of liver impairment with atomoxetine.
In line with other shared care documents, see ‘areas of responsibility’
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 respiratory depressant effects.
Methylphenidate and dexamfetamine are Schedule 2 Controlled Drugs. Controlled Drug
prescribing requirements apply.
DoH recommends a maximum of 30 days supply for Schedule 2 Controlled Drugs.
Stimulant medicines can be abused. As such, the prescriber must bear in mind any
factors relating to the patient 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: these must be swallowed whole and not chewed, crushed or
broken. The tablet shell is eliminated from the body; patients 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
foods. Contents must be swallowed whole and not chewed, crushed or broken.
If Medikinet XL® or Equasym XL® is ingested with high fat content food, absorption may
be delayed by approximately 1.5 hours.
Atomoxetine is an ocular irritant and capsules are not intended to be opened. In the event
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
7
SHARED CARE PRESCRIBING GUIDELINE
of capsule contents coming in contact with the eye, the affected eye should be flushed
immediately with water.
Key
references:
NICE Clinical Guideline no. 72. ADHD. September 2008
http://www.nice.org.uk/nicemedia/live/12061/42107/42107.pdf
British National Formulary http://www.bnf.org/bnf/index.htm
Drug and Safety Update, Medicines and Healthcare Regulatory Agency website (accessed 7
December 2012)
http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON041211
British Association for Psychopharmacology 2006; Evidence based guidelines for
management of Attention-Deficit/hyperactivity Disorder in Adolescents in transition to Adult
Services and in Adults
Summaries of Product Characteristics http://www.medicines.org.uk/emc/
Ritalin SPC
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=1316
Concerta XL SPC
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=19549
Equasym XL SPC
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=15804
Medikinet XL SPC
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=19510
Atomoxetine SPC
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=14482
Dexedrine SPC (Also available from Mental Health Medicines Information)
http://www.adhd-institute.com/Treatment/Dexedrine%20SPC.pdf
Accessed December 2012
Date prepared: December 2012
Date approved: February 2013
Review date: February 2013
8