South West London and St George’s Mental Health NHS Trust

Shared Care Guideline: Prescribing Agreement
Methylphenidate, Lisdexamfetamine▼, 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: ………………………………………
NHS.net e-mail: …………………………… / Patient Details:
Name: ………………………………………………
Address: ……………………………………………
DOB: ……/………/…………
Hospital (IAPTus/RiO) No: ………………………
NHS number (10 digits): …………………………
Consultant & Clinic name: …………………………
Address: ......
Tel no: ……………………………………… NHS.net e-mail: ……………………………
Diagnosis: / Drug name & dose to be prescribed by GP:
Next hospital appointment: / Date of appointment:
Dear Dr. ……………………..,
Your patient was seen on the date above and I have started the medicine above for the above diagnosis. I am requesting your agreement to sharing the care of this patient two weeks from the date of this letter in accordance with the attached Shared Care Prescribing. Please take particular note of Section 2 where the areas of responsibilities for the GP and patient are detailed.
Patient information has been given outlining potential aims and side effects of this treatment.
Please monitor:
Height, weight and blood pressure and pulse six monthly.
For signs of liver toxicity with atomoxetine.
For diversion of lisexamfetamin, dexamfeatmaine or methylphenidate.
For deterioration in behaviour or adverse effects (refer back to specialist).
Report all adverse effect of lisdexamfetamine to the MHRA via the yellow card system.
The following investigations have been performed on the date below are acceptable for shared care.
Test / Result / Date / Test / Result / Date
Blood pressure / Weight (incl centiles)
Pulse / Height (incl centiles)
Mental Health Team please ensure the latest blood results are attached with this agreement
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: …/…/…..
Working in partnership with

SHARED CARE PRESCRIBING GUIDELINE
Methylphenidate, Lisdexamfetamine▼, 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
Reviewed: October 2015 / Review date:Sept 2017
Approved by (date approved):
SWLStG Drug & Therapeutic Committee
Mental Health Interface Prescribing Forum
Participating Clinical Commissioning Groups (CCG) / Participating Hospital Trusts
Kingston CCG
Dr Anthony Hughes, GPon behalf of Medicines Management Committee
Seema Buckley, Chief Pharmacist / SWL & St. George’s Mental Health Trust
Dr M Zwi (CAMHS Consultant)
Dianne Adams (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, Chief Pharmacist
NHS Wandsworth
Dr Gillian Ostrowsky, Associate Medical Director
Nick Beavon, Chief Pharmacist
Sutton CCG
Dr Chris Kears, Mental Health Lead
Sarah Taylor, Chief Pharmacist

1

Date approved: Oct 2015

Review date: Sept 2017

SHARED CARE PRESCRIBING GUIDELINE

Methylphenidate, Lisdexamfetamine▼, Dexamfetamine and Atomoxetine in under 6-18yrs

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 / GP
  1. To assess the patient and establish a diagnosis of attention-deficit hyperactivity disorder; to determine a management strategy and communicate this to the family & GP. The diagnosis must clearly be demonstrated through a detailed report outlining the current problems, developmental history and presence of “core signs” of 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 (inc driving), a discussion of the reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and adverse effects.
  3. Ensure relevant baseline investigations are performed, documenting height, weight and blood pressure and pulse and additional relevant investigations (e.g. ECG if family history of arrhythmias or sudden death).
  4. Initiate treatment with methylphenidate, lisdexamfetamine, 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 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.
  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 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 consultant will advise about the options for ongoing care within adult services for each patient’s particular needs.
/
  1. Monitor patient’s overall health and well being.
  2. Prescribe methylphenidate, lisdexamfetamine, 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.
  3. Monitor height, weight and blood pressure and pulse six monthly. Notify the specialist if the patients growth is lower than that exected, taking in to consideration the physical stature or the biological family.
  4. Advise the patient to attend specialist appointments (at least annually).
  5. 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.
  6. Although misuse of methylphenidate, lisdexamfetamine 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, lisdexamfetamine and dexamfetamine are controlled drugs.
  7. Observe for potential liver toxicity withatomoxetine, signs include abdominal pain,unexplained nausea, and malaise, darkeningof urine or jaundice.
  8. To report any adverse drug reactions to the Medicines and Healthcare Products Regulatory Authority (MHRA) as part of the yellow card scheme.
  9. Refer back to consultant if patient becomes pregnant.

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

3.COMMUNICATION AND SUPPORT

Hospital contacts:
(the referral letter will indicate named consultant) / Out of hours contacts & procedures:
Enter the contact details of your local
CAMHS / Psychiatrist & Pharmacist available via the
SWLStG 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
3.2. Medicines Information Website
4.Information in the British National Formulary for Children (BNFc)
5.Summary of Product Characteristics
6.NICE Guidelines –QS 39 ADHD (July 2013) andCG 72 (Sept 08)
7.ADHD support groups e.g. or (both of whom receive sponsorship from the pharmaceutical industry)
8.SWLSTG Psychiatric Medicines Information 020 3513 6829.

4.CLINICAL INFORMATION

Indication(s) / 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.
Place in therapy / Methylphenidate(CD Sch 2)(instant release and long acting –Xenidate XL® (Concerta XL®for 27 mg dose), Equasym XL®, and Medikinet XL®).
First line for the management of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years and over and in adolescents.
Lisdexamfetamine(CD Sch 2)▼
Second line for attention Deficit/Hyperactivity Disorder refractory to methylphenidateunless there are substance misuse issues or anxiety issues in which case atomoxetine should be used as the second line choice. This includes where there is a risk of the diversion of a controlled drug.
Dexamfetamine(CD Sch 2)
Refractory hyperkinetic states, or if methylphenidate fails.
Atomoxetine
First or second line management of Attention Deficit/HyperactivityDisorder (ADHD) in children aged 6 years and over and in adolescents especially where there are substance misuse issues or anxiety issues. This includes where there is a risk of the diversion of a controlled drug.
Please note: Methylphenidate is the usual preferred drug of choice, however some patients may require an alternative drug according to individual need.
Therapeutic summary / Methylphenidate, lisdexamfetamine, dexamfetamine and atomoxetine reduce the ADHD “core symptoms”: excessive inattention, hyperactivity and impulsivity.
Duration of treatment /
  • Determined on an individual basis. Discontinue treatment periodically (usually annually), or if no improvement.
  • Transition to adult psychiatric services to be managed on an individual case basis as currently the numbers are very few, but increasing.

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
  • Initiate at 5mg OD or BD; increase dosage if necessary weekly, by increments of 5-10mg per day
  • Usual maximum dosage 60mg per day in divided doses (usually at intervals of 3-4 hours)
Modified release preparations
1st line -Xenidate-XL® 18mg, 36mg MR tablets
  • Initiate at 18mg daily; increase dose gradually according to needs and response of the patient.
  • Usuallyup to 54mg per day (max 108mg daily unlicensed).
  • Concerta-XL® is available for the 27mg strength
Equasym XL® 10mg, 20mg, 30mg MR capsules – consists of an immediate-realease component (30% of the dose) and a modified-release component (70% of the dose)
  • Initiate at 10mg once daily in the morning before breakfast, increased gradually if necessary
  • Usuallyup to 60mg daily.
Medikinet XL® 10mg, 20mg, 30mg, 40mg MR capsule – consists of an immediate-realease component (50% of the dose) and a modified-release component (50% of the dose)
  • Initiate at 10mg once daily in the morning before breakfast, increased gradually if necessary
  • Usuallyup to 60mg daily.
Dosage equivalence (immediate release (IR) vs. modified release (MR)):
5mg TDS (IR) = 18mg OD Xenidate-XL®
10mg TDS (IR) = 36mg OD Xenidate-XL®
15mg TDS (IR) = 54mg OD Xenidate-XL®
5mg BD (IR) = 10mg Equasym XL®
10mg BD (IR) = 20mg Equasym XL®
15mg BD (IR) = 30mg Equasym XL®
2nd line Lisdexamfetamine▼
Elavanse® 30mg, 50mg 70mg tablets
  • Starting dose 30mg given each morning
  • Increase to 50mg after one week if no response
  • Increase up to 70mg after a further week if required
  • Maximum dose 70mg
Dexamfetamine (Schedule 2 controlled drug)
Dexamfetamine sulphate 5mg tablets (standard release)
  • Initiate at 5–10 mg daily for children over 6yrs.
  • 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.
  • Black Triangle Drug▲(MHRA encourages the reporting of all suspected reactions).
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 gradually as required to recommended maintenance dose of approx. 1.2mg/kg/day.
  • 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.

Summary of adverse effects
Consult Summary of Product Characteristics(SmPC) for a full list. / Adverse effect / Frequency / Management
Methylphenidate / Nervousness and insomnia / >10% / Review dose and/or omit afternoon or evening dose if using three times daily
Abdominal pain, nausea and vomiting / 1-10% / Administer with food
Athralgia, nasopharyngitis, cough or pharyngolaryngeal pain. / 1-10% / Review is persistent or troublesome.
Moderately reduced weight and slight growth retardation during prolonged use / 0.01-0.1% / Discontinue if significant weight loss or growth retardation (see monitoring requirements below).
Increased pulse and blood pressure / 1-10% / Use with caution in patients with underlying cardiovascular medical.
Discontinue if significant hypertension.
Headache / 1-10% / Refer back to psychiatric team if persistent or troublesome.
Drowsiness/dizziness / 1-10% / Refer back to psychiatric team if persistent or troublesome.
Tachycardia /palpitations/arrythmias / 1-10% / Discontinue if significant
Decreased appetite / 1-10% / Usually transient
Dry mouth / 1-10% / Refer back to psychiatric team if persistent or troublesome.
Rash, pruritis / 1-10% / Refer back to psychiatric team if persistent or troublesome.
Leucopenia, thrombocytopenia, anaemia / <0.01% / Check FBC if recurrent nose bleeds, bruising or recurrent infections.
Convulsions / <0.01% / Discontinue if increase in frequency and discuss with psychiatric team.
Suicide attempt / <0.01% / Discuss with psychiatric team.
Neuroleptic Malignant Syndrome (Fever, diaphoresis, rigidity, confusion. Elevated: CK, leukocytosis & LFTs. Fluctuating: consciousness, BP & tachycardia. / <0.01 / Unsure if NMS if due to methylphenidate. Maybe related to other medicines. Discontinue if signs appear.
Sudden death / 0.01% / Prevention. See ‘areas of responsibility’ and references.
Dexamfetamine / Insomnia, restlessness,
irritability, euphoria, tremor,
dizziness, headache and
other symptoms of overstimulation
have been
reported. / Not stated / Reduce dose, ensure not
given too near to bed time.
Medication review by CAMHS.
Dry mouth, unwanted
anorexia, other GI
symptoms, sweating, convulsions and cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure. / Refer back to psychiatric team if persistent or troublesome.
Sudden death / Prevention. See ‘areas of responsibility’ and references.
Reduced height and weight gain / Drug-free periods may allow catch-up in growth but withdraw slowly to avoid inducing depression or renewed hyperactivity.
Neuroleptic Malignant Syndrome (Fever, diaphoresis, rigidity, confusion. Elevated: CK, leukocytosis & LFTs. Fluctuating: consciousness, BP & tachycardia) / Stop and urgently refer to A&E.
Lisdexamfetamine▼ / Insomnia, aggression,irritability, euphoria, tremor, tics, drowsiness, dizziness, headache, dysphoria, anxiety, labile mood, seizures, hallucinations andother symptoms of overstimulation
have beenreported. / Common or very common / Reduce dose, ensure not
given too near to bed time.
Medication review by CAMHS.
Dry mouth, unwantedanorexia, other GI
symptoms, sweating, convulsions and cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure. / Very common / Refer back to psychiatric team if persistent or troublesome.
Reduced height and weight gain, decreased appetite / Common or very common / Drug-free periods may allow catch-up in growth but withdraw slowly to avoid inducing depression or renewed hyperactivity.
Neuroleptic Malignant Syndrome (Fever, diaphoresis, rigidity, confusion. Elevated: CK, leukocytosis & LFTs. Fluctuating: consciousness, BP & tachycardia) / Frequency not known / Stop and urgently refer to A&E.
Cardiomyopathy. / Frequency not known / Stop and urgently refer to A&E.
Atomoxetine / Nausea, vomiting or abdo pain / >10% / Usually settles in the first month of therapy.
Insomnia / >10% / Refer to psychiatric team.
Dysuria, urinary retention / 1-10% / Stop if persistent and refer to psychiatric team.
Visual disturbances e.g. mydriasis / 0.1-1% / Stop, refer to psychiatric team
Cardiac disorders such as arrhythmias, tachycardia, palpitation / 1-10% / Discontinue therapy and treat clinically.