SHARED CARE AGREEMENT

DEXAMFETAMINE for ADULT ADHD Version: 1

Date: 07/2013

Author: Tracey Green Dr Saif Sharif

Document Author Written by: Tracey Green Signed: Date: 15/07/2013 Job Title: Pharmacist Mental Health Approval at DAC: 07/03/14 Trust Executive Committee date: April 2014 CCG Board date: April 2014 Review Date:March 2016 Effective Date:March 2014

Status: Draft

Comment:

Version Control History: Version:

1

Date:

Author:

Status:

03/14

Tracey Green Saif Sharif

Approved

Comment:

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.

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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

Lead Consultant Lead Nurse Lead Pharmacist Medicines Information

Isle of Wight NHS Trust 01983 524081 Dr Saif Sharif Tracey Green 01983 534622

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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 . The usual starting dose is 10mg dexamfetamine sulphate a day, given in divided doses. Dosage may be increased if necessary by 10mg a day at weekly intervals to a suggested maximum of 60mg a day.

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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 Dexamfetamine is not licensed for use in adults with ADHD but is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) when remedial measures alone prove insufficient. In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. 3 PREPARATION Dexamfetamine 5mg tablets

4 SAFETY ISSUES Please see the current BNF and SPC 4.1 Dose The usual starting dose is 10mg dexamfetamine sulphate a day, given in divided doses. Dosage may be increased if necessary by 10mg a day at weekly intervals to a suggested maximum of 60mg a day.

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4.2 Contra-indications Hypersensitivity to dexamfetamine or other amfetamine derivatives or any of the excipients. Patients with symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or severe hypertensive disease. Patients with advanced arteriosclerosis. During or for 14 days after treatment with an MAO inhibitor. Patients with a history of drug abuse or alcohol abuse. Patients with hyperthyroidism, glaucoma, porphyria or hyperexcitability. Patients with Gilles de la Tourette syndrome or similar dystonias. Pregnancy and lactation. .

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4.3 Cautions Cardiovascular Cardiomyopathy has been reported with chronic amfetamine use.Sudden death has been reported in association with the use of stimulants of the central nervous system.Although some structural cardiac abnormalities alone maycarry an increased risk of sudden death, stimulant products are not recommended in adults with known structural cardiac abnormalities. Cardiovascular status should be carefully monitored. Blood pressure and pulse should be measured at each adjustment of dose and then at least every 3 months. Psychiatric disorders Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products. In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders, dexamfetamine should not be given unless the benefits outweigh the risks to the patient. Suicidal tendency Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician. Consideration should be given to the exacerbation of an underlying psychiatric condition and to a possible causal role of methylphenidate treatment. Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible discontinuation of methylphenidate. Tics Dexamfetamine is associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported. Family history should be assessed and clinical evaluation for tics or Tourette's syndrome should precede use of methylphenidate. Patients should be regularly monitored for the emergence or worsening of tics during treatment with dexamfetamine. Monitoring should be at every adjustment of dose and then at least every 6 months or every visit. Seizures Dexamfetamine should be used with caution in patients with epilepsy. Dexamfetamine may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities. If seizure frequency increases or newonset seizures occur, dexamfetamineshould be discontinued Withdrawal Careful supervision is required during withdrawal, since this may unmask depression as well as chronic over-activity. Some patients may require long-term follow-up.

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Abuse, misuse and diversion Patients should be carefully monitored for the risk of diversion, misuse and abuse of dexamfetamine. Dexamfetamine should be used with caution in patients with known drug or alcohol dependency because of a potential for abuse, misuse or diversion. Chronic abuse of dexamfetamine can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Patient age, the presence of risk factors for substance use disorder (such as co-morbid oppositional-defiant or conduct disorder and bipolar disorder), previous or current substance abuse should be taken in to account when deciding on a course of treatment for ADHD. Caution is called for in emotionally unstable patients, such as those with a history of drug or alcohol dependence, because such patients may increase the dosage on their own initiative. For some high-risk substance abuse patients, dexamfetamine or other stimulants may not be suitable and non-stimulant treatment should be considered. Withdrawal Careful supervision is required during withdrawal, since this may unmask depression as well as chronic over-activity. Some patients may require long-term follow-up.

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4.4 Side Effects

Cardiac disorders: cardiomyopathy, myocardial infarction, palpitations, tachycardia Eye disorders: mydriasis, visual disturbance Gastrointestinal disorders: abdominal cramps, colitis ischaemic, diarrhea, dry mouth, Nausea Investigations: blood pressure decreased, blood pressure increased Metabolism and nutrition disorders: acidosis, anorexia, weight loss. Musculoskeletal and connective tissue disorders: rhabdomyolysis Nervous system disorders: ataxia, choreoathetoid movements, concentration difficulties, convulsion, dizziness, dyskinesia, dysgeusia, fatigue, headache, hyperactivity, hyperreflexia, intracranial haemorrhage, neuroleptic malignant syndrome, stroke, tremor, Tourette’s syndrome Psychiatric disorders: aggressive behaviour, anxiety, confusion, delirium, depression, drug dependence, dysphoria, emotional lability, euphoria, hallucination, impaired cognitive test performance, insomnia, irritability, libido altered, nervousness, night terrors, obsessive-compulsive behavior, panic states, paranoia, psychosis/ psychotic reactions, restlessness, tics Renal and urinary disorders: renal damage Reproductive system and breast disorders: impotence Skin and subcutaneous tissue disorders: alopecia, rash, sweating, urticaria Vascular disorders: cardiovascular collapse, cerebral vasculitis

Cessation of, or reduction in, amfetamine use that has been heavy and prolonged can result in withdrawal symptoms. Symptoms include dysphoric mood, fatigue, vivid and unpleasant dreams, insomnia or hypersomnia, increased appetite, psychomotorretardation or agitation, anhedonia and drug craving.

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4.4 Drug Interactions Adrenoreceptor blocking agents (e.g. propanolol), lithium and α methyltyrosine may antagonise the effects of dexamfetamine. Disulfiram may inhibit metabolism and excretion. The concurrent use of tricyclic antidepressants may increase the risk of cardiovascular side effects.Concurrent use of MAOI’s or use within the preceding 14 days may precipitate a hypertensive crisis. Concurrent use of beta-blockers may result in severe hypertension and dexamfetamine may result in diminished effect of other anti-hypertensives such as guanethidine. Phenothiazines may inhibit the actions of dexamfetamine. Amfetamines may delay the absorption of ethosuximide, phenobarbital and phenytoin. Acute dystonia has been noted with concurrent administration of haloperidol. Haloperidol and Chlorpromazine block dopamine and norepinephrine re-uptake, thus inhibiting the central stimulant effects of amfetamines. The analgesic effect of morphine may be increased and its respiratory depressant effects decreased with concurrent use of morphine and dexamfetamine. Amfetamines potentiate the analgesic effects of meperidine. Concomitant administration of clonidine and dexamfetamine may result in an increased duration of action of dexamfetamine. Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of dexamfetamine. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase urinary excretion of dexamfetamine. Both groups of agents lower blood levels and efficacy of dexamfetamine. Gastrointestinal alkalizing agents (sodium bicarbonate, etc) increase the absorption of amfetamines. Urinary alkalizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amfetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and efficacy of amfetamines. Alcohol may exacerbate the CNS adverse reactions of psychoactive drugs, including dexamfetamine. It is therefore advisable for patients to abstain from alcohol during treatment.

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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 ADHDASRS 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.

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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 intervals If the patient misses more than 2 appointments the Community Consultant will inform the GP ho 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 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. 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 CG72 National Institute for Health and Clinical Excellence: Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults

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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. Dexamfetamine 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

Dr

Copy to Patient / Hospital Notes / GP

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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

Dr Practice address

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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

Protected Groups Age Gender Reassignment Race Sex and Sexual Orientation Religion or belief Disability Marriage and Civil Partnerships Human Rights Pregnancy and Maternity

of 20

Service Users

Staff

Wider Community

y

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Show how this document or service change meets the aims of the Equality Act 2010? Equality Act – General Duty Eliminates unlawful discrimination, harassment, victimization and any other conduct prohibited by the Act.

Relevance to Equality Act General Duties This shared cared agreement enhances the opportunities for treatment of adults suffering with ADHD to access services. This was previously accessible only to those under18

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

What is the purpose of this document or service change?

Who will benefits?

What are the expected outcomes? Why do we need this document or do we need to change the service?

Scope To make more available , and more safely available medications for ADHD in the adult population

The service users

The appropriate treatment of adult ADHD

To ensure support for the service that has been put in place

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.

Equality Analysis and Action Plan This template should be used when assessing services, functions, policies, procedures, practices, projects and strategic documents

Information 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

No major change

Adjust your document or service change proposals

Continue to implement the document or service change

Description Your analysis demonstrates that the proposal is robust and the evidence shows no potential for discrimination. This involves taking steps to remove barriers or to better advance equality outcomes. This might include introducing measures to mitigate the potential effect. Despite any adverse effect or missed opportunity to advance equality, provided you can satisfy yourself it does not unlawfully discriminate.

Justification of your analysis

This is lessening any discrimination

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Equality Analysis and Action Plan This template should be used when assessing services, functions, policies, procedures, practices, projects and strategic documents

Stop 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 this change When will the document or service change be reviewed? Who will be responsible for monitoring and review? What information will you need for monitoring? How will you engage with stakeholders, staff and service users 5.2

To see the number of adult patients receiving shared care 2 years The team running the service

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 strategic documents

http://www.equalityhumanrights.com/advice-and-guidance/new-equality-actguidance/equality-act-guidance-downloads/

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