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Submission to Medicines Management CommitteeDate of Meeting: Person presenting at meeting:
Agenda No: Attachment:
Methylphenidate, Lisdexamfetamine▼ Dexamfetamine and Atomoxetine for Attention Deficit Hyperactivity Disorder in Adults >18 years of age / Purpose of Report:Describes the shared care of these medicines in adults
Report Author:
Joseph Wilson / Submitting Team/Organisation:
SWLStG DTC
1.1. Contact details:
1.2. Executive Summary: (precise purpose of document)
Describes how the shared care of ADHD medicines in adults is set out.Describes the recent formulary changes.
1.3. Key sections for particular note (paragraph/page), areas of concern etc:
Lisdexamfetamine▼ has been added as 2nd line.It is cheaper than atomoxetine & is as effective as methylphenidate.
Atomoxetine will be used less due to delayed onset of action, it will likely be reserved for those with anxiety symptoms or there is a risk of diversion if prescribing methylphenidate or lisdexamfetamine▼.
Concerta/xenidate are not bioequivalent to medikinet or equasym; these formulations are not interchangeable.
Xenidate has been added to the formulary as it is bioequivanlent to concerta. Xenidate is not available as 27mg tabs so concerta 27mg will stay on the formulary.
All patients should be switched and new initiations should use xenidate.
Recommendation(s) for the committee:
Approve addition to the formulary and change of recommended formulary.
Amend local scriptswitch messages.
GPs and practice pharmacists should switch patients from concerta to Xenidate where possible.
Committees which have previously discussed/approved/declined the report and/or
Leads who have been consulted and key outcomes:
Approved at SWLStG DTC.
Yourhealthcare waiting to have it approved by KCCG for them to use.
Financial Implications:
Lisdexamfetamine▼ cheaper than current 2nd line.
Xenidate is cheaper than current 1st choice (Concerta)
Other Implications if applicable:
N/a
How will this document be disseminated and to whom?
Your healthcare
CCG MMCs
SWLStG DTC
Child and adolescent and LD psychiatrists and those specialising in adult ADHD.
SHARED CARE AGREEMENT
Methylphenidate, Lisdexamfetamine▼ 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:
Name: ……………………………………………….
Address: …………………………………………..
Tel no: ……………………………………………..
Fax no: …………………………………………….
Email: …………………………………… / Patient Details:
Name: ………………………………………………
Address: ……………………………………………
DOB: ……/………/…………
Hospital number: …………………………………
NHS number (10 digits): …………………………
Mental Health Team details:
Consultant name: ………………………………….
Clinic name: ………………………………………
Address:……………………………………… / Mental Health Team details contd:
Tel no: ………………………………………
Fax no: ………………………………………
Email: ……………………………………….
Diagnosis: / Drug name & dose to be prescribed by GP:
Next hospital appointment: / Date patient seen
Dear Dr. ……………………..,
Your patient was seen on the date above and is prescribed the medicine(s) for the above diagnosis and are stabilised on this treatment. I am requesting your agreement to sharing the care of this patient from two weeks from the date of this letter in accordance with the attached Shared Care Prescribing Guideline. Please take particular note of the section where the areas of responsibility for the GP and patient are detailed.
Patient information has been given outlining potential aims and side effects of this treatment.
The patient has given me consent to treatment under a shared care prescribing agreement (with your agreement) and has agreed to comply with instructions and follow up requirements.
.
The following investigations below were performed on and are acceptable for shared care. Please monitor:
weight: at 3m, 6m then 6 monthly, heart rate and BP: after every dose change and 3 monthly.
Observe for signs of liver toxicity should atomoxetine be prescribed.
Report all side effects of lisdexamfetamine▼ as the MHRA ‘yellow card scheme’, should it be prescribed.
Test / Result / Date / Test / Result / Date
Blood pressure / Weight (inc BMI)
Pulse
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
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: ………………………………………….………. GMC no:…………………………………..
GP signature: ……………………………………………… Date: …….…/.………./…………….……..
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SHARED CARE AGREEMENTMethylphenidate, Lisdexamfetamine▼, 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 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: December 2012 Reviewed: Feb 2016 / Next Review date: February 2018
Approved by (date approved):
Mental Health Interface Prescribing Forum
(Mar 2015).
SWL & St. George’s Mental Health Trust
Drug & Therapeutics Committee (Feb 2015) / Prepared by:
Dr Morris Zwi, CAMHS Consultant
Dr David Li, Consultant Psychiatrist
Kyra Sycamore, Lead Pharmacist, SWLStG
Reviewed by: Deirdre Evans, Pharmacy, SWLSTG 2015
Joseph Wilson, Pharmacy,SWLSTG, 2016
Participating Primary Care organisation / Participating Provider Trust
Richmond CCG
Dr Stavroula Lees, lead GP for Mental health
Emma Richmond, Chief Pharmacist / SWL & St. George’s Mental Health Trust
Dr Emma Whicher, Medical Director
Dianne Adams, Chief Pharmacist
Kingston CCG
Dr Anthony Hughes, GP on behalf of Medicines Management Committee
Seema Buckley, Director & Chief Pharmacist / Your Healthcare
Moira Ford, Business Lead
Derek Cock, Chief Pharmacist Kingston Hospital
Dr S Palod, Consultant Psychiatrist
Merton CCG
Dr Andrew Otley, Clinical Director, Mental Health
Sedina Agama, Chief Pharmacist
Sutton CCG
Mr Les Ross, Co-chair of Sutton & Merton CCGs Medicines Management Committee
Sarah Taylor, Chief Pharmacist
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Date prepared: December 2012 Date reviewed: Feb 2015 Date next review: February 2017
SHARED CARE PRESCRIBING AGREEMENT
2. 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 4 weeks (up to 3 months) of medication on initiation.
3. Areas of responsibility
Adult ADHD services role: / GP role:1. To assess the patient and establish a diagnosis of attention-deficit hyperactivity disorder; to determine a management strategy and communicate this to the patient & 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 patients who meet the criteria laid-down in the NICE guidelines for ADHD (CG72 September 2008). This should include consideration of contra-indications, interactions and cautions, 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. Discuss any unlicensed prescribing of medication with the patient and obtain consent. Document in patients notes.
4. Ensure relevant baseline investigations are performed, documenting weight, blood pressure, pulse and any additional relevant investigations (e.g. ECG if family history of arrhythmias or sudden death).
5. Initiate treatment with methylphenidate (1st line), lisdexamfetamine, dexamfetamine or atomoxetine and prescribe medication until the dose has been stabilised (usually 4 weeks, up to 3 months). During this time monitor the patient as required for symptom control and side effects. Discontinue if no improvement of symptoms.
6. 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.
7. 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. Once ADHD symptoms have been reduced and the medication has been stabilised (see 5 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.
9. Discontinue treatment periodically (usually annually) and advise the GP accordingly. Provide supervision and assessment of the patient during these periods.
10. To accept referrals of patients prescribed medicines to treat ADHD who become pregnant. / 1. Monitor the patient’s overall health and wellbeing.
2. Review the patient in accordance with specialist advice
3. 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 the patient has been transferred and accepted.
4. Monitor weight, blood pressure and pulse should be undertaken as per NICE guidance (weight: at 3m, 6m then 6 monthly, heart rate and BP: after every dose change and 3 monthly). Send copies of the results to the specialist. Notify the specialist if the patient is experiencing adverse effects from the medicine.
5. Check that the patient is attending arranged specialist appointments (at least annually).
6. Re-refer the patient or seek specialist advice from the psychiatrist if there is deterioration in ADHD symptomatology, behaviour, or adverse effects of medication.
7. Although misuse of methylphenidate, lisdexamfetamine and dexamfetamine is rare, the GP should alert the specialist to previous misuse of drugs by the patient if such information is known. This is particularly important because methylphenidate, lisdexamfetamine and dexamfetamine are controlled drugs.
8. Observe for potential liver toxicity with atomoxetine, signs include abdominal pain, unexplained nausea, and malaise, darkening of urine or jaundice.
9. To report any adverse drug reactions to the Medicines and Healthcare Products Regulatory Authority (MHRA) as part of the yellow card scheme.
10. Refer back to consultant if patient becomes 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).
4. COMMUNICATION AND SUPPORT
Hospital contacts:(the referral letter will indicate named consultant) / Out of hours contacts & procedures:
Enter the contact details of your local
Adult ADHD Service / The on-call Psychiatrist and Pharmacist can be contacted via SWLStG switchboard on
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 latest British National Formulary (BNF)
5. Summary of Product Characteristics www.emc.medicines.org.uk
6. NICE Guidelines – CG 72 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)
5. CLINICAL INFORMATION
Indication(s) / - 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 (CG 72) 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.