SHARED CARE AGREEMENT ATOMOXETINE for ADULT ADHD

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Shared Care Guideline Atomoxetine for Adult ADHD

SHARED CARE AGREEMENT

ATOMOXETINE for ADULT ADHD

Version: Date: Author: Status: Comment: 1 01/2014 Tracey Green Draft Dr Saif Sharif

Document Author Written by: Tracey Green Signed: Date: 15/07/2013 Job Title: Pharmacist Mental Health

Approval DAC: 07/03/14

Trust Executive Committee date: April 2014

CCG Board date: April 2014

Review Date: March 2016

Effective Date: March 2014

Version Control History:

Version: Date: Author: Status: Comment: 1 March 2014 Tracey Green Approved Dr Saif Sharif

Shared Care Guideline February 2014

Isle of Wight NHS Trust 01983 524081 Lead Consultant Dr Saif Sharif Lead Nurse Lead Pharmacist Tracey Green Medicines Information 01983 534622

NB: This Shared Care Agreement relates to the Isle of Wight NHS Trust hereafter referred to as the Trust.

This shared care guideline has been produced to support the seamless transfer of prescribing and patient monitoring from secondary to primary care and provides an information resource to support clinicians providing care to the patient. It does not replace discussion about sharing care on an individual patient basis.

This guideline was prepared using information available at the time of preparation, but users should always refer to the manufacturer’s current edition of the Summary of Product Characteristics (SPC or “data sheet”) for more details.

The Trust holds full responsibility for any adverse events preventable by monitoring stated within the agreement at all times that prescribing continues within the limits set by the agreement.

Shared Care Guideline February 2014 2

CONTENTS PAGE

SECTION DESCRIPTION PAGE

1 INTRODUCTION 4

2 INDICATIONS 4

3 PREPARATION 4

4 SAFETY ISSUES 5

4.1 Dose 5

4.2 Contra-indications (also see current BNF or SPC) 5

4.3 Cautions 5

4.4 Common Side Effects (also see current BNF or SPC) 5

4.5 Drug Interactions (also see current BNF or SPC) 5

4.6 Pre-treatment Assessment 6

4.7 Routine Safety Monitoring 6

5 RESPONSIBILITY OF CONSULTANT 6

6 RESPONSIBILITY OF NURSE (if applicable) 6

7 RESPONSIBILITY OF GP 6

8 RESPONSIBILITY OF PATIENT 6

9 FURTHER INFORMATION 7

10 CONSULTANT LETTER 8

11 GP RESPONSE FAX FORM 9

12 EQUALITY ANALYSIS & ACTION PLAN 10

Shared Care Guideline February 2014 3

1 INTRODUCTION

ADHD is a behavioural syndrome characterised by the core symptoms of hyperactivity, impulsivity and inattention. Symptoms of ADHD can overlap with symptoms of other related disorders, in adults they include personality disorders, bipolar disorder, obsessive compulsive disorder and substance misuse. (1) ADHD is thought to affect about 3–9% of school-age children and young people in the UK, and about 2-4% of adults worldwide, including the UK,

Adult ADHD is widely under-recognised. Most young people with a diagnosis of ADHD will go on to have significant difficulties in adulthood, which may include continuing ADHD, personality disorders, emotional and social difficulties, substance misuse, unemployment and involvement in crime. (1) It is suggested that ADHD in childhood can persist into adulthood in at least 30% of patients. Adults may receive a first diagnosis of ADHD having never been diagnosed as a child but have a history of symptoms

Drug treatment is the first-line treatment for adults with ADHD with either moderate or severe levels of impairment. Methylphenidate is the first-line drug. Psychological interventions without medication may be effective for some adults with moderate impairment, but there are insufficient data to support this recommendation. If methylphenidate is ineffective or unacceptable, atomoxetine or dexamfetamine can be tried. If there is residual impairment despite some benefit from drug treatment, or there is no response to drug treatment, CBT may be considered.

Following titration and dose stabilisation, prescribing and monitoring should be carried out under locally agreed shared care arrangements with primary care (1).

Give a brief outline of the drug and disease state, along with the rationale for shared care (i.e. what are the benefits of sharing care for this drug?)

Drug Treatment

Drug, dose, route of administration etc

Adults Atomoxetine should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance daily dose is 80mg to 100mg. The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated.

Shared Care Guideline February 2014 4

Other treatments

Methylphenidate is the first-line drug. Psychological interventions without medication may be effective for some adults with moderate impairment, but there are insufficient data to support this recommendation. If methylphenidate is ineffective or unacceptable, atomoxetine or dexamfetamine can be tried. If there is residual impairment despite some benefit from drug treatment, or there is no response to drug treatment, CBT may be considered. In cases of potential substance misuse and diversion Atomoxetine is first line or Methylphenidate XL preparations could be considered

2 INDICATIONS

Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and atomoxetine should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life.

3 PREPARATION

STRATTERA* 10mg, 18mg, 25mg, 40mg, 60mg, 80 mg or 100 mg hard capsules

4 SAFETY ISSUES Please see the current BNF and SPC

4.1 Dose

For oral use. Atomoxetine can be administered as a single daily dose in the morning, with or without food. Patients who do not achieve a satisfactory clinical response (tolerability [e.g. nausea or somnolence] or efficacy) when taking Atomoxetine as a single daily dose might benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening.

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4.2 Contra-indications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs). Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with a MAOI. Treatment with a MAOI should not be initiated within 2 weeks after discontinuing atomoxetine.

Atomoxetine should not be used in patients with narrow-angle glaucoma, as in clinical trials the use of atomoxetine was associated with an increased incidence of mydriasis.

Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders. Severe cardiovascular disorders may include severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels). Severe cerebrovascular disorders may include cerebral aneurysm or stroke.

Atomoxetine should not be used in patients with pheochromocytoma or a history of pheochromocytoma.

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4.3 Cautions

Suicide-related behaviour: Suicide-related behaviour (suicide attempts and suicidal ideation) has been reported in patients treated with atomoxetine.. Patients who are being treated for ADHD should be carefully monitored for the appearance or worsening of suicide related behaviour.

Sudden death and pre-existing cardiac abnormalities: Sudden death has been reported in patients with structural cardiac abnormalities who were taking atomoxetine at usual doses. Although some serious structural cardiac abnormalities alone carry an increased risk of sudden death, atomoxetine should only be used with caution in patients with known serious structural cardiac abnormalities and in consultation with a cardiac specialist.

Cardiovascular effects: Atomoxetine can affect heart rate and blood pressure. Most patients taking atomoxetine experience a modest increase in heart rate (mean <10 bpm) and/or increase in blood pressure (mean <5 mm Hg). Long-term sustained changes in blood pressure may potentially contribute to clinical consequences such as myocardial hypertrophy. As a result of these findings, patients who are being considered for treatment with atomoxetine should have a careful history and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease. It is recommended that heart rate and blood pressure be measured and recorded before treatment is started and, during treatment, after each adjustment of dose and then at least every 3 months to detect possible clinically important increases.. For adults, current reference guidelines for hypertension should be followed. Patients who develop symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt specialist cardiac evaluation. In addition, atomoxetine should be used with caution in patients with congenital or acquired long QT or a family history of QT prolongation

Hepatic effects: Very rarely, spontaneous reports of liver injury, manifested by elevated hepatic enzymes and bilirubin with jaundice, have been reported. Also very rarely, severe liver injury, including acute liver failure, have been reported. Atomoxetine should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

Psychotic or manic symptoms: Treatment-emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, mania or agitation in patients without a prior history of psychotic illness or mania can be caused by atomoxetine at usual doses. If such symptoms occur, consideration should be given to a possible causal role of atomoxetine, and discontinuation of treatment should be considered. The possibility that Atomoxetine will cause the exacerbation of pre-existing psychotic or manic symptoms cannot be excluded.

Shared Care Guideline February 2014 7

Aggressive behaviour, hostility or emotional lability: Hostility (predominantly aggression, oppositional behaviour and anger) was more frequently observed in clinical trials adults treated with Atomoxetine compared to those treated with placebo. Patients should be closely monitored for the appearance or worsening of aggressive behaviour, hostility or emotional lability.

Possible allergic events: Although uncommon, allergic reactions, including anaphylactic reactions, rash, angioneurotic oedema, and urticaria, have been reported in patients taking atomoxetine.

Seizures: Seizures are a potential risk with atomoxetine. Atomoxetine should be introduced with caution in patients with a history of seizure. Discontinuation of atomoxetine should be considered in any patient developing a seizure or if there is an increase in seizure frequency where no other cause is identified.

Patients who are being treated for ADHD with atomoxetine should be monitored for the appearance or worsening of anxiety symptoms, depressed mood and depression or tics.

Shared Care Guideline February 2014 8

4.4 Common Side Effects

Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10),. System Organ Very common Common Class ≥1/10 ≥1/100 to <1/10

Metabolism and Appetite decreased Nutrition Disorders

Psychiatric Insomnia2 Agitation*, libido decreased, sleep disorder, Disorders depression and depressed mood, * anxiety

Nervous System Headache Dizziness, dysgeusia, , paraesthesia, Disorders somnolence (including sedation), tremor

Cardiac Disorders Palpitations, tachycardia

Vascular disorders Flushing. Hot flush.

Gastrointestinal Dry mouth, nausea Abdominal pain1, constipation, dyspepsia, Disorders flatulence, vomiting

Skin and Dermatitis, hyperhydrosis, rash Subcutaneous Tissue Disorders

Renal and urinary Dysuria, pollakuria, urinary hesitation, disorders urinary retention

Reproductive Dysmenorrhoea, ejaculation disorder, System and Breast erectile dysfunction, prostatitis, male genital Disorders pain

General Disorders Asthenia, fatigue, lethargy, chills, feeling and Administration jittery, irritability, thirst Site Conditions

Investigations Blood pressure increased3, Weight decreased Heart rate increased3

1Also includes abdominal pain upper, stomach discomfort, abdominal discomfort and epigastric discomfort.

2 Also includes initial insomnia, middle insomnia and terminal (early morning wakening) insomnia.

3 Heart rate and blood pressure findings are based on measured vital signs.

4 Includes anaphylactic reactions and angioneurotic oedema.

Shared Care Guideline February 2014 9

4.4 Drug Interactions

MAOIs: Atomoxetine should not be used with MAOIs (see Section 4.3 Contraindications).

CYP2D6 inhibitors (SSRIs (e.g., fluoxetine, paroxetine), quinidine, terbinafine): In patients receiving these drugs, atomoxetine exposure may be 6-to 8-fold increased and Css max 3 to 4 times higher, because it is metabolised by the CYP2D6 pathway. Slower titration and final lower dosage of atomoxetine may be necessary in patients who are already taking CYP2D6 inhibitor drugs. If a CYP2D6 inhibitor is prescribed or discontinued after titration to the appropriate atomoxetine dose has occurred, the clinical response and tolerability should be re-evaluated for that patient to determine if dose adjustment is needed.

Caution is advised when combining atomoxetine with potent inhibitors of cytochrome P450 enzymes other than CYP2D6 in patients who are poor CYP2D6 metabolisers as the risk of clinically relevant increases in atomoxetine exposure in vivo is unknown.

Salbutamol (or other beta2 agonists): Atomoxetine should be administered with caution to patients treated with high dose nebulised or systemically administered salbutamol (or other beta2 agonists) because cardiovascular effects can be potentiated. Attention should be paid to monitoring heart rate and blood pressure, and dose adjustments may be justified for either atomoxetine or salbutamol (or other beta2 agonists) in the event of significant increases in heart rate and blood pressure during coadministration of these drugs.

There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs (such as neuroleptics, class IA and III anti- arrhythmics, moxifloxacin, erythromycin, methadone, mefloquine, tricyclic antidepressants, lithium, or cisapride), drugs that cause electrolyte imbalance (such as thiazide diuretics), and drugs that inhibit CYP2D6.

Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold (such as tricyclic antidepressants or SSRIs, neuroleptics, phenothiazines or butyrophenone, mefloquine, chloroquine, bupropion or tramadol). . In addition, caution is advised when stopping concomitant treatment with benzodiazepines due to potential withdrawal seizures.

Anti-hypertensive drugs: Atomoxetine should be used cautiously with anti-hypertensive drugs. Because of a possible increase in blood pressure, atomoxetine may decrease the effectiveness of anti-hypertensive drugs / drugs used to treat hypertension. Attention should be paid to monitoring of blood pressure and review of treatment of atomoxetine or anti-hypertensive drugs may be justified in the case of significant changes of blood pressure.

Pressor agents or drugs that increase blood pressure: Because of possible increase in effects on blood pressure, atomoxetine should be used cautiously with pressor agents or medications that may increase blood pressure (such as salbutamol). Attention should be paid to monitoring of blood pressure, and review of treatment for either atomoxetine or pressor agents may be justified in the case of significant change in blood pressure.

Shared Care Guideline February 2014 10

Drugs that affect noradrenaline: Drugs that affect noradrenaline should be used

cautiously when co-administered with atomoxetine because of the potential for

additive or synergistic pharmacological effects. Examples include antidepressants,

such as imipramine, venlafaxine, and mirtazapine, or the decongestants

pseudoephedrine or phenylephrine.

Drugs that affect gastric pH: Drugs that elevate gastric pH (magnesium

hydroxide/aluminium hydroxide, omeprazole) had no effect on atomoxetine

bioavailability.

Drugs highly bound to plasma protein: In vitro drug-displacement studies were

conducted with atomoxetine and other highly-bound drugs at therapeutic

concentrations. Warfarin, acetylsalicylic acid, phenytoin, or diazepam did not affect

the binding of atomoxetine to human albumin. Similarly, atomoxetine did not affect

the binding of these compounds to human albumin.

4.5 Routine Monitoring

Initial BP and Pulse LFT’s Sexual dysfunction

Ongoing BP and Pulse every 3 months and after dose increases Monitoring for tics , seizures and psychiatric comorbidity at 6 every months and after dose increases Monitoring for ADR’s

4.6 Pre-treatment Assessment

Prior to referral the GP will screen the patient for ADHD using the Adult ADHD-ASRS Screening tool

Prior to referral and at the request of the Specialist (if referred from Secondary Care) investigation of the patients cardiovascular risk for stimulant therapy including completion of the Medical Assessment tool. This would accompany the referral. This is defined as a basic physical examination of the cardiovascular system if there is a history of syncope or there are identifiable cardiovascular risks in family history or past medical history. These risks may require investigation beyond physical examination such as ECG/Echo.

Shared Care Guideline February 2014 11

5 RESPONSIBILITY OF CONSULTANT e.g. Confirmation of diagnosis, monitoring of clinical condition, initiation of drug treatment, assessment of response at given time intervals.

The Community Psychiatrist will provide a diagnostic service for individuals who are referred with a suspected diagnosis of ADHD

The Community Psychiatrist will titrate medication, once initiated, in close dialogue with the patient and carers.

The Community Psychiatrist will monitor for response during the initiation phase as well as monitoring for reports of ADR`s from the patient, carer, GP or any individual of the MDT involved in that patients management.

The Community Psychiatrist will liaise with the GP and share the patients care once a stable, optimum dose has been achieved. It is accepted that until a stable dose has been achieved it is the responsibility of the Psychiatrist to monitor the effects of medication on mental state. The GP is responsible for monitoring Physical Health and pre/post dose change BP and Pulse.

The Community Psychiatrist will provide ongoing annual follow-up once stable to assess the need for ongoing medication.

For those already with a diagnosis of ADHD in transition from CCAMHS/Paediatrics the consultant will initially review need for medication and then at annual interevals

If the patient misses more than 2 appointments the Community Consultant will inform the GP who will stop the prescriptions

6 RESPONSIBILITY OF NURSE (if applicable)

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7 RESPONSIBILITY OF GP e.g. Continuation of drug treatment, liaison with initiating consultant regarding any complications of treatment, monitoring as specified in 4.7 above.

Prior to referral the GP will screen the patient for ADHD using the Adult ADHD-ASRS Screening tool

Monitor the patients overall health including BP, Pulse and Weight as directed and as per NICE guidelines (CG72)

Prescribe the ongoing medication once a stable optimum dose has been received under a shared care agreement. The Community consultant will inform of non-attendance for review that will lead to the discontinuation of medication

Report any ADR`s to the Specialist including development of tics and other psychiatric symptomatology

8 RESPONSIBILITY OF PATIENT e.g. Attendance at hospital and GP appointments.

The patient must agree to the routine monitoring, medications will not be issued without this. Two missed appointments will result in cessation of supply

The patient must attend the appointments with the GP and the yearly review

The patient must undertake to keep the medication safe realising the potential for abuse and diversion

9 FURTHER INFORMATION

References 1) National Institute for Health and Care Excellence: CG72 Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults

Shared Care Guideline February 2014 13

ADHD Adult Assessment Clinic Arthur Webster Clinic 35 Landguard Manor Road Shanklin Isle of Wight PO37 7HZ

Tel 01983 866179 Fax 01983 867516

Lesley Mew Clinical Team Leader e-mail: [email protected]

(Insert date) Re: (Drug Name) shared care agreement

Patient’s details

Important: Action Needed

Dear Dr

I have seen this patient in clinic and believe that he/she is suitable for treatment under the Shared Care arrangements.

Atomoxetine treatment was started on (Insert date), for the diagnosis of (Insert diagnosis) The patient is now on a dose of (Insert dose) which after review is accepted and tolerated by the patient.

I am satisfied this patients condition and medication is stable, and is a suitable candidate for Shared Care Prescribing within Primary care.

Conditions are correct to hand over routine prescribing and monitoring of this patients treatment as per drug guideline attached.

Please complete the form below and fax back to (Insert fax no)

I thank you in anticipation.

Yours Sincerely

Copy to Patient / Hospital Notes / GP

Shared Care Guideline February 2014 14

ADHD Adult Assessment Clinic Arthur Webster Clinic 35 Landguard Manor Road Shanklin Isle of Wight PO37 7HZ

Tel 01983 866179 Fax 01983 867516

Lesley Mew Clinical Team Leader e-mail: [email protected]

Shared Care Monitoring re. (Drug Name)

Fax back to: (Insert fax number)

Delete as applicable

I agree to take over prescribing and monitoring responsibility for this patient as per shared care guidelines.

In light of exceptional circumstances are I am not willing to undertake shared-care for this patient because

…………………………………………………………………………………………………..

……………………………………………………………………………………………………

…………………………………………………………………………………………………… Reasons for not accepting patients into Primary Care will lead to a discussion with the consultant and the reasons will be monitored by clinical governance leads.

Patient name: Date of Birth

Address Post Code

Yours sincerely

Practice address

Shared Care Guideline February 2014 15 Equality Analysis and Action Plan

This template should be used when assessing services, functions, policies, procedures, practices, projects and strategic documents Step 1. Identify who is responsible for the equality analysis.

Name: Tracey Green Role: Phamacist

Other people or agencies who will be involved in undertaking the equality analysis:

Step 2. Establishing relevance to equality

Relevance Service Protected Groups Staff Wider Community Users Age y Gender Reassignment Race Sex and Sexual Orientation Religion or belief Disability Marriage and Civil Partnerships Human Rights Pregnancy and Maternity

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Shared Care Guideline Atomoxetine for Adult ADHD

Show how this document or service change meets the aims of the Equality Act 2010?

Equality Act – General Relevance to Equality Act General Duties Duty This shared cared agreement enhances the Eliminates unlawful opportunities for treatment of adults suffering with discrimination, harassment, ADHD to access services. This was previously victimization and any other conduct prohibited by the accessible only to those under18 Act.

Advance equality of opportunity between people who share a protected characteristic and people who do not share it

Foster good relations between people who share a protected characteristic and people who do not share it.

Step 3. Scope your equality analysis

Scope To make more available , and more safely available What is the purpose of this medications for ADHD in the adult population document or service change?

The service users Who will benefits?

The appropriate treatment of adult ADHD What are the expected outcomes?

Why do we need this To ensure support for the service that has been document or do we need to put in place change the service?

It is important that appropriate and relevant information is used about the different protected groups that will be affected by this document or service change. Information from your service users is in the majority of cases, the most valuable.

Shared Care Guideline February 2014

Equality Analysis and Action Plan

This template should be used when assessing services, functions, policies, procedures, practices, projects and strategicInformat documentsion sources are likely to vary depending on the nature of the document or service change. Listed below are some suggested sources of information that could be helpful:

Results from the most recent service user or staff surveys. Regional or national surveys Analysis of complaints or enquiries Recommendations from an audit or inspection Local census data Information from protected groups or agencies. Information from engagement events.

Step 4. Analyse your information.

As yourself two simple questions: What will happen, or not happen, if we do things this way? What would happen in relation to equality and good relations?

In identifying whether a proposed document or service changes discriminates unlawfully, consider the scope of discrimination set out in the Equality Act 2010, as well as direct and indirect discrimination, harassment, victimization and failure to make a reasonable adjustment.

Findings of your analysis

Description Justification of your analysis No major change Your analysis This is lessening any demonstrates that the discrimination proposal is robust and the evidence shows no potential for discrimination. Adjust your document This involves taking or service change steps to remove proposals barriers or to better advance equality outcomes. This might include introducing measures to mitigate the potential effect. Continue to implement Despite any adverse the document or effect or missed service change opportunity to advance equality, provided you can satisfy yourself it does not unlawfully discriminate.

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Equality Analysis and Action Plan

This template should be used when assessing services, functions, policies, procedures, practices, projects and strategicStop documents and review Adverse effects that cannot be justified or mitigated against, you should consider stopping the proposal. You must stop and review if unlawful discrimination is identified

5. Next steps.

5.1 Monitoring and Review. Equality analysis is an ongoing process that does not end once the document has been published or the service change has been implemented.

This does not mean repeating the equality analysis, but using the experience gained through implementation to check the findings and to make any necessary adjustments.

Consider:

How will you measure the effectiveness of To see the number of adult patients this change receiving shared care When will the document or service change 2 years be reviewed? Who will be responsible for monitoring The team running the service and review? What information will you need for monitoring? How will you engage with stakeholders, staff and service users

5.2 Approval and publication The Executive Board will be responsible for ensuring that all documents submitted for approval will have completed an equality analysis.

Under the specific duties of the Act, equality information published by the organisation should include evidence that equality analyses are being undertaken. These will be published on the organisations “Equality, Diversity and Inclusion” website.

Useful links:

Equality and Human Rights Commission

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Equality Analysis and Action Plan

This template should be used when assessing services, functions, policies, procedures, practices, projects and strategichttp://www.equalityhumanrights.com/advice documents -and-guidance/new-equality-act- guidance/equality-act-guidance-downloads/

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