Shared Care Guideline
Methylphenidate (immediate release and long acting), Atomoxetine, Dexamfetamine and Lisdexamfetamine for treatment of Adult ADHD
Shared Care Guideline written by: Lucy Reeves, Chief Pharmacist & Dr Dimitrios Paschos, Consultant Psychiatrist, Camden & Islington NHS Foundation Trust- Approved by: Drug & Therapeutics Group: 8.4.15
- Agreed with lead commissioning CCGs
· NHS Islington Clinical Commissioning Group: 16.7.15
· NHS Camden Clinical Commissioning Group: 22.7.15
Date of next review: July 2017
Dear GP,
This shared care arrangement outlines the way in which the responsibilities for managing the prescribing of methylphenidate (immediate release and long acting), atomoxetine, dexamfetamine and lisdexamfetamine used for adults with a confirmed diagnosis of ADHD, using DSM-V / ICD 10 criteria, should be shared between the specialist Consultant Psychiatrist, the patient, their carer(s) and yourself as the patient’s General Practitioner.
You have been invited to participate but if you are not confident to undertake these roles, then you are under no obligation to do so. Please inform the consultant and CCG prescribing advisors as to why, so that support can be provided to address your concerns or to agree appropriate alternative management plans. We would be grateful if you would reply to this request as soon as practicable to indicate your decision.
Sharing of care assumes communication between the specialist, GP, patient and their carer(s). The intention to ‘share care’ should be explained to the patient and their carer(s) by the doctor initiating treatment. It is important that patients and their carer(s) are consulted about this treatment and are in agreement with it.
BACKGROUND
ADHD is a spectrum disorder of neurodevelopmental origin and is characterised by the core symptoms of inattention, hyperactivity and impulsivity. In adults with moderate and severe ADHD such symptoms can often cause significant occupational/educational, social and psychological impairment. NICE guidance recommends medication as first choice in the treatment of adults with moderate / severe ADHD. Medication should be part of a holistic treatment plan that address emotional, educational and social care needs. Psychological treatment (CBT) is also effective in the management of ADHD in adults and can be used when the patient does not want to try medication or in conjunction with pharmacological treatment where indicated. Assessment and initiation of medication should take place under the supervision of an appropriately qualified healthcare professional with expertise in the diagnosis and management of ADHD.
The diagnostic criteria for the condition are described in both DSM-V and ICD-10 and require that:
· The symptoms have persisted for at least six months to a degree that is maladaptive and inconsistent with the development level of the person
· There must be clear evidence of clinically significant impairment in social or academic/employment functioning
· Some impairment is present in two or more settings (usually at home, at work and social activities)
· There is evidence of ADHD in childhood
· The symptoms do not occur exclusively during the course of an autism spectrum condition, schizophrenia or other psychotic disorder and are not better accounted for by other mental disorders
SHARED CARE CRITERIA
Drug treatments used for ADHD will be prescribed for the treatment of adults with a confirmed diagnosis of moderate to severe ADHD using DSM-V / ICD 10 criteria. Initial dose titration of the chosen medication will take place under the care of Camden and Islington NHS Foundation Trust. Once the patient has been titrated to maintenance dose, usually over a period of 4-8 weeks, they will be given a further prescription for 28 days of their maintenance dose. The GP will then continue care under the supervision of the Consultant Psychiatrist if it provides the optimum solution for the patient.
The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For further information please refer to the Summary of Product Characteristics or contact a member of the appropriate team. PHA43: July 2015 Page 1 of 9
ROLES & RESPONSIBILITIES
Consultant Psychiatrist1. To offer a specialist assessment to the patient and establish a diagnosis of ADHD; to determine the severity of the disorder and devise a management strategy and communicate this to the patient & GP.
2. To contact GP to formally request shared care (see letter – appendix 1) if the patient wishes to try treatment with medication.
3. To request, review or carry out all necessary tests before starting treatment with medication including specialist ADHD assessment, medical assessment (including blood tests, BMI, pulse, BP and ECG where indicated), screen for substance and alcohol misuse. Communicate the results of these tests to the patients GP.
4. Initiate treatment in accordance with NICE1,2 and locally agreed clinical guidelines for methylphenidate (immediate or prolonged release), atomoxetine, dexamfetamine or lisdexamfetamine.
5. Provide the patient and the carer with initial information, including Patient Information Leaflet (PIL), regarding the treatment benefits and possible adverse effects. Inform the patient that treatment is off-label, where applicable.
6. Inform patient and carer of shared care arrangements
7. Initiate treatment, titrate to maintenance dose and continue to prescribe until prescribing responsibility is taken over by the patient’s GP. In uncomplicated cases this process should take 8-12 weeks to be completed.
8. Review and consider discontinuing treatment if there is no worthwhile benefit or unacceptable side effects, and ensure patient is aware and involved in the decision. Advise GP of when to review for potential discontinuation or reduction in treatment and when/how to review for ongoing need.
9. Advise the GP by letter of any changes in treatment and results of monitoring with a 2 week target for GPs to receive this information.
10. Be available to offer telephone advice to the GP or review the patient in the clinic after prescribing has been taken over by Primary Care and for as long as the patient takes ADHD medication.
11. Report any adverse events reported by the patient during initiation and stabilisation on treatment to the MHRA where appropriate via http://yellowcard.mhra.gov.uk
General Practitioner
1. Return completed standard letter (appendix 1) to the consultant accepting shared care as soon as possible (within 14 days) and ideally at the point of referral if a diagnosis of ADHD is strongly suspected. If shared care is declined, discuss reasons and appropriate alternative management with the specialist service.
2. Prescribe maintenance treatment following initiation by specialist and adjust dose on recommendation of the specialist.
3. Monitor patient’s overall health and wellbeing and offer follow up and monitoring of BP, Pulse, BMI, ECG as recommended by NICE for adults who take ADHD medication (see clinical monitoring section)
4. Evaluate with the patient the need to continue treatment every year as part of a regular medication review.
5. Seek advice (over the phone or by requesting a review in the clinic) whenever there are concerns or questions about the patient’s ongoing treatment with medication for ADHD.
6. Monitor adverse effects and possible medicines interactions when new medications are prescribed or there is a change in the patient’s physical health.
7. Report any adverse events reported by the patient/carer to the consultant and MHRA where appropriate via http://yellowcard.mhra.gov.uk
8. Stop treatment on recommendation of the Consultant
9. Review repeat prescriptions prior to issuing e.g. for medicine adherence/to avoid stockpiling and report irregularities to the Consultant Psychiatrist
Patient/Carer
1. Share any concerns in relation to their treatment including effectiveness/lack of effectiveness.
2. Inform specialist or GP of any medication being taken, including over-the-counter products
3. Ensure they attend for routine monitoring requirements
4. Report any adverse effects to the specialist or GP regarding their treatment.
Commissioners
1. To support GPs to make the decision whether or not to accept clinical responsibility for prescribing.
2. To support Trusts in resolving issues that may arise as a result of shared care.
The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For further information please refer to the Summary of Product Characteristics or contact a member of the appropriate team. PHA43: July 2015 Page 1 of 9
SUPPORTING INFORMATION
For further details refer to the manufacturer’s Summary of Product Characteristics (SPC) www.medicines.org.uk and current BNF www.bnf.org/bnf
Licensed indications
Currently methylphenidate and dexamfetamine preparations do not have UK marketing authorisation for use in adults with ADHD. Hence, the prescription of methylphenidate and dexamfetamine after the age of 18 years is ‘off-label’. Informed consent should be obtained and documented.
Atomoxetine and lisdexamfetamine are licensed for the treatment of ADHD in adult patients when the presence of the condition in childhood can be confirmed.
NICE guidance recommends medication as first choice in the treatment of adults with moderate / severe ADHD.
Dosage and Administration
Refer to current BNF (section 4.4) for most recent information
Drugs covered by the agreement / Brand / Action / DosageMethylphenidate Instant Release / Ritalin, Equasym, Medikinet / CNS stimulant
Schedule 2 controlled drug / 5mg BD - TDS up to a max of 100mg/daily in divided doses
Methylphenidate Slow Release / Equasym XL, Medikinet XL
Concerta XL / CNS stimulant
Schedule 2 controlled drug / 10mg once daily up to max of 100mg once daily
18mg once daily up to a max of 108mg once daily.
Dexamfetamine / Dexamfetamine Sulphate / CNS stimulant
Schedule 2 controlled drug / 5mg BD up to a max of 60mg/daily in divided doses
Lisdexamfetamine / Elvanse / CNS stimulant
Schedule 2 controlled drug / 30mg once daily up to a max of 70mg once daily
Atomoxetine / Strattera / Selective Noradrenaline reuptake inhibitor (not a controlled drug) / For adults of up to 70 kg - initiate at 500 micrograms/kg daily, increase after 7 days. Maintenance dose - 1.2 mg/kg daily, either as a single dose or in two divided doses (max dose 120mg daily)
For adults of over
70 kg - initiate at a daily dose of 40 mg for 7 days. usual Maintenance dose - 80-100 mg daily (max dose 120mg daily)
Prescribing Schedule II Controlled Drugs
Methylphenidate, Dexamfetamine and Lisdexamfetamine (and all relevant formulations i.e Ritalin, Medikinet, Equasym, Concerta, Elvanse) are schedule II controlled drugs (CD) and hence subject to prescription requirements i.e. must be indelible, signed by the prescriber, be dated and specify the prescriber’s address. The prescription must always state:
· Name and address of patient
· Form and strength of preparation (e.g. 20mg capsules)
· Dose (e.g. 20mg TDS)
· Total quantity or number of dose units in words AND figures e.g. 420mg = Four Hundred and Twenty milligrams or Twenty One (21) capsules.
A prescription can be given for a maximum of 28 days.
Refer to most recent BNF for further details
Adverse effects
Adverse Effect / Frequency / GP ManagementMETHYLPHENIDATE
Nervousness and insomnia / >10% / Review dose and/or omit afternoon/evening dose if using TDS regime - refer to consultant for advice.
Decreased appetite / 1-10% / Usually transient. Try taking medicine with food if it persists. Refer to consultant for advice if continues
Headache, drowsiness, dizziness / 1-10% / Refer to consultant for advice if continues
Abdominal pain, diarrhoea, nausea & vomiting, dry mouth, dyspepsia / 1-10% / Occurs at initiation. May be alleviated by concomitant food intake. Refer to consultant for advice if continues
Tachycardia, arrhythmia, palpitations, hypertension / 1-10% / Monitor. Discontinue if significant refer back to ADHD consultant & specialist cardiologist if indicated.
Tic, aggression, anxiety, irritability / 1-10% / Discontinue if tics develop. Refer back to consultant.
Drug induced psychosis (e.g. hallucinations, restlessness) depression, mood swings / < 1% / Discontinue. Refer back to consultant.
DEXAMFETAMINE
Aggressive behaviour, anxiety, confusion, delirium, depression, euphoria, insomnia, irritability, tics, night tremors / Not stated / Reduce dose & ensure not given too near bedtime. Discontinue if tics develop. Refer back to consultant.
Paranoia, psychosis / Not stated / Discontinue. Refer back to consultant.
Palpitations, tachycardia, change in blood pressure, cardiomyopathy, chest pain. / Not stated / Monitor. Check pulse after every dose change. ECG if necessary. Discontinue if significant & refer back to ADHD consultant & specialist cardiologist if indicated.
LISDEXAMFETAMINE ▼ / (adults)
Insomnia / >10% / Review dose - ensure taken in morning – refer to consultant for advise
Decreased appetite
(weight decreased) / >10%
(1-10%) / Try taking medicine with food if it persists. Refer to consultant for advice if continues
Headache, dry mouth / >10% / Refer to consultant for advice if continues
Anorexia, diarrhoea, upper abdominal pain, nausea / 1-10% / May be alleviated by concomitant food intake. Refer to consultant for advice if continues
Anxiety, agitation, libido decreased, erectile dysfunction, dizziness, restlessness, tremor, irritability, fatigue, feeling jittery, hyperhidriosis / 1-10% / Refer back to consultant.
Tachycardia, palpitations, blood pressure increased, / 1-10% / Monitor. Discontinue if significant & refer back to ADHD consultant & specialist cardiologist if indicated.
Depression, tic, affect lability, dysphoria, euphoria, mania, dermatillomania, logorrhea, somnolence, dyskineasia / 0.1-1% / Discontinue if tics develop. Refer back to consultant.
Blurred vision, vomiting, urticaria, rash, pyrexia / 0.1-1% / Discontinue. Refer back to consultant.
Psychotic episodes, hallucination, aggression, seizure / Not known / Discontinue. Refer back to consultant
ATOMOXETINE
Appetite decreased, dry mouth, nausea / >10% / Usually settles after 1st month of treatment. Refer to consultant for advice if continues
Headache, somnolence, insomnia / >10% / Usually settles after 1st month of treatment. Refer to consultant for advice if continues
Increased BP and heart rate / >10% / Monitor. Discontinue if clinically indicated. Refer back to ADHD consultant and cardiologist if indicated.
Abdominal pain, constipation, dyspepsia, flatulence, vomiting / 1-10% / Usually settles after 1st month of treatment. Refer to consultant for advice if continues
Weight decrease / 1-10% / Usually settles after initial weight loss
Palpitations, tachycardia / 1-10% / Monitor. Discontinue if clinically indicated. Refer back to ADHD consultant and cardiologist if indicated.
Libido decreased, sleep disorder, dizziness, sinus headache, tremor, fatigue, lethargy, agitation / 1-10% / Refer back to consultant
Dysuria, urinary hesitation, urinary retention / 1-10% / Refer back to consultant
Dysmenorrhoea, irregular menstruation, ejaculation disorder, erectile dysfunction, male genital pain / 1-10% / Refer back to consultant
Suicide-related events, aggression, hostility and emotional lability, / 0.1-1% / Discontinue drug. Refer back to consultant
QT interval prolongation, / 0.1-1% / Discontinue if significant & refer back to ADHD consultant & specialist cardiologist.
Liver toxicity, abnormal liver function tests, jaundice, hepatitis, / 0.001-0.1% / Discontinue drug. Refer back to consultant
seizure, psychosis (including hallucinations), / 0.001-0.1% / Discontinue drug. Refer back to consultant
Suspected adverse drug reactions should be reported to the MHRA using the Yellow Card Scheme at www.yellowcard.mhra.gov.uk . Refer to BNF for further details.