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North of Tyne Area and Gateshead Prescribing Committee Lisdexamfetamine ADHD Shared Care Guideline (Children and Young People) Indication: Lisdexamfetamine is a CNS stimulant drug used in the treatment of Introduction Attention Deficit Hyperactivity Disorder (ADHD) following a comprehensive assessment and diagnosis. It is approved for third line use when other treatments have been inadequate or not tolerated in children over 6 years and young people (licensed use). Transfer to GP after 6 month symptom control under shared care arrangement (amber drug). Specialist Responsibilities Dosage and Administration See BNF, BNFC and NICE ADHD CG 72 Clinical Guideline 2008 For all children and young people - the starting dose is lisdexamfetamine (Elvanse®) 30mg taken once daily in the morning. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 20 mg once daily in the morning. The dose may be increased by 10 or 20 mg increments, at approximately weekly intervals. Administered at the lowest effective dosage. Discontinue if response insufficient after 1 month; maximum 70 mg per day. Lisdexamfetamine may be taken with or without food. It may be swallowed whole, or the capsule opened and the entire contents emptied and mixed with a soft food such as yogurt or in a glass of water or orange juice. If the contents include any compacted powder, a spoon may be used to break apart the powder in the soft food or liquid. The contents should be stirred until completely dispersed. The patient should consume the entire mixture of soft food or liquid immediately; it should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed. The patient should not take anything less than one capsule per day and a single capsule should not be divided. In the event of a missed dose, Lisdexamfetamine dosing can resume the next day. Afternoon doses should be avoided because of the potential for insomnia Available as: Elvanse® 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules Lisdexamfetamine is a schedule 2 controlled drug and is therefore subject to normal controlled drug regulations. Diagnose the condition and assess if the patient is suitable for treatment with lisdexamfetamine (as per the pre-drug assessment in NICE guidance) Provide patient/carer with relevant information on use, side effects and need for monitoring of medication Arrange shared care with the patient’s GP when the patient has received at least 6 months treatment from the specialist team. Request shared care when the final script is issued by the specialist allowing at least one month for the shared care agreement to be arranged Provide the GP with relevant information for each patient, including: o Treatment to be undertaken by GP (dose, any dosage titrations etc.) o System of monitoring and recording of progress and side effects Monitoring of condition: Assess response to treatment and the need to continue therapy by reviewing the patient at regular intervals during initiation and 6 monthly thereafter Re-evaluate the need for continued therapy beyond 1 year, particularly when the patient has reached a stable and satisfactory response Side-effect monitoring: Appetite, height & weight: Every 6 months BP & heart rate: Approximately every 3 months as per specialist’s review Prepared by: NTW NHS FT Implementation Date: March 2016 1 Review Date: March 2018 GP Responsibilities Adverse Effects, Precautions, Contraindications Common Drug Interactions Communication schedule, and with each dose change Assess for: development of tics, psychotic symptoms, anxiety, or seizures Advise discontinuation if no symptom improvement after a reasonable trial Review the treatment regularly, sending a written summary to the GP whenever the patient is reviewed Provide any other advice or information for the GP if required Inform GP if failing to attend appointments Supervise any discontinuation of treatment or onward referral to adult service if appropriate. Prescribe lisdexamfetamine- it is strongly recommended that prescriptions are issued for maximum treatment duration of one month, in line with good practice guidance for controlled drug prescribing. Report significant deviations from the prescribing pattern to the specialist Monitor + record the therapy in accordance with specialist’s written directions Report any adverse events to the specialist, and the usual bodies (e.g. MHRA). Contact specialist if concerned about any aspects of the patient’s treatment e.g. Failure to collect prescriptions Use with caution in epilepsy. If seizure frequency increases - discontinue Dizziness, nervousness, drowsiness and headaches are commonly experienced upon initiation of therapy. Loss of appetite (some weight loss may occur) and insomnia may also occur. These effects are often mild and transient and may be controlled by a reduction in dose. Other adverse effects include: abdominal pain, nausea and vomiting (can be alleviated with concomitant food intake), dry mouth, emotional lability, temporary growth retardation, changes in blood pressure, tachycardia, palpitations, skin rash, itching or bruising Effects on ability to drive and use machines - Lisdexamfetamine can impair ability to drive and operate machinery. It is included in regulations under 5a of the Road Traffic Act 1988. Inform patients: The medicine is likely to affect driving ability so avoid driving until you know how you are affected. It is an offence to drive while under the influence of lisdexamfetamine, however, you would not be committing an offence (called 'statutory defence') if: o The medicine has been prescribed to treat a medical problem o You have taken it according to the prescribers’ instructions o It was not affecting your ability to drive safely Monoamine oxidase inhibitors (MAOIs) - amfetamine should not be administered during or within 14 days following the administration of MAOIs as they may precipitate hypertensive crisis Antihypertensives: Amfetamines may reduce effectiveness Amfetamines potentiate the analgesic effect of narcotic analgesics. Effect of lisdexamfetamine can be decreased by: beta-blockers (e.g. propranolol), lithium and phenothiazines Concurrent use of tricyclic antidepressants may increase risk of cardiovascular side effects Acute dystonia has been noted with concurrent haloperidol administration. ADHD Specialists MON – FRI, 09:00 – 17:00 Newcastle and Gateshead CYPS:- 0191 246 6913 (Benton House) North Tyneside CAMHS:- 0191 2196725 (Albion Road Clinic) 0191 200 7435 (Balliol Centre) Northumberland CYPS:- 01670 394 256 (Villa 9, Northgate) This information is not inclusive of all prescribing information and potential adverse effects. Please refer to full prescribing data in the SPC or the BNF Prepared by: NTW NHS FT Implementation Date: March 2016 2 Review Date: March 2018 Private and Confidential Lisdexamfetamine - Shared Care Request/Confirmation Specialist to complete first section of form and send to patient’s GP. GP to complete second section of form and return to specialist within 28 days. A copy of the full shared care guideline can be viewed at www.northoftyneapc.nhs.uk Patient details (use hospital label if preferred) Specialist Prescriber …………………………………… Department …………………………………… Hospital Name …………………………………………… Address …………………………………………… …………………………………… …………………………………………… ………... Postcode ................................. M/F NHS or Hosp. Reg. No. DoB ………... ……………… Treatment Requested for Prescribing in Accordance with an Approved Shared Care Arrangement Drug Name Lisdexamfetamine Dose Frequency Indication Other Information (if appropriate) Signed (Specialist Prescriber Name (print) Date To be completed by GP Please tick one box I ACCEPT the proposed shared care arrangement for this patient or I ACCEPT the proposed shared care arrangement with the caveats below or I DO NOT ACCEPT the proposed shared care arrangement for this patient My caveats / reason(s) for not accepting include: ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. Signed …………………………………… Name (print) ....................................... Date …………. (Patients GP) N.B. Participation in this shared care arrangement implies that prescribing responsibility is shared between the specialist prescriber and the patient’s GP Prepared by: NTW NHS FT Implementation Date: March 2016 3 Review Date: March 2018