Download Methylphenidate - Isle of Wight NHS Trust

SHARED CARE AGREEMENT
METHYLPHENIDATE 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 Committe date: April 2014
CCG Board date: April 2014
Review Date:March 2016
Effective Date:March 14
Status:
Draft
Comment:
Version Control History:
Version:
1
Date:
Author:
Status:
March 2014
Tracey Green
Dr 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.
Shared Care Guideline April 2013
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
Lead Consultant
Lead Nurse
Lead Pharmacist
Medicines Information
Isle of Wight NHS Trust 01983 524081
Dr Saif Sharif
Tracey Green
01983 534622
Shared Care Guideline April 2013
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
Metthylphenidate - orally
Initial treatment should begin with low doses (5 mg three times daily for immediaterelease preparations; the equivalent dose for modified-release preparations)
the dose should be titrated against symptoms and side effects over 4–6 weeks
the dose should be increased according to response up to a maximum of
100 mg/day
modified-release preparations should usually be given once daily and no more than
twice daily
modified-release preparations may be preferred to increase adherence and in
circumstances where there are concerns about substance misuse or diversion
immediate-release preparations should be given up to four times daily.
Shared Care Guideline April 2013
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
Methylphenidate 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, this is a licensed use.
3 PREPARATION
Stimulant dose equivalents (mg) of immediate-release methylphenidate (IR-MPH)
compared with brands of modified-release methylphenidate:
IR-MPH 15 mg is equivalent to Concerta XL 18 mg;
IR-MPH 30 mg is equivalent to Concerta XL 36 mg,
IR-MPH 45 mg is equivalent to Concerta XL 54 mg;
IR-MPH 60 mg is equivalent to Concerta XL 72 mg (licensed up to 54 mg).
4 SAFETY ISSUES Please see the current BNF and SPC
4.1 Dose
Treatment must be stopped if the symptoms do not improve after appropriate dosage
adjustment over a one-month period. If paradoxical aggravation of symptoms or other
serious adverse events occur, the dosage should be reduced or discontinued.
Shared Care Guideline April 2013
5
4.2 Contra-indications
• Known sensitivity to methylphenidate or to any of the excipients in Ritalin.
• Glaucoma
• Phaechromocytoma
• During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or
within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis
• Hyperthyroidism or thyrotoxicosis
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal
tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia,
psychopathic/borderline personality disorder.
• Diagnosis or history of severe and episodic (Type 1) Bipolar (affective) disorder (that is
not well controlled)
• Pre-existing cardiovascular disorders including 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)
• Pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities
including vasculitis or stroke or known risk factors for cerebrovascular disorders
Shared Care Guideline April 2013
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4.3 Cautions
Cardiovascular status
Patients who are being considered for treatment with stimulant medications should have a
careful history (including assessment for a family history of sudden cardiac or unexplained
death or malignant arrthymia) 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. Patients who develop symptoms such as palpitations, exertional
chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac
disease during methylphenidate treatment should undergo a prompt specialist cardiac
evaluation. 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.
Cerebrovascular disorders
Cerebral vasculitis appears to be very rare idiosyncratic reaction to methylphenidate
exposure. There is little evidence to suggest that patients at higher risk can be identified
and the initial onset of symptoms may be the first indication of an underlying clinical
problem. Early diagnosis, based on a high index of suspicion, may allow the prompt
withdrawal of methylphenidate and early treatment. The diagnosis should therefore be
considered in any patient who develops new neurological symptoms that are consistent
with cerebral ischemia during methylphenidate therapy. These symptoms could include
severe headache, numbness, weakness, paralysis, and impairment of coordination, vision,
speech, language or memory.
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, methylphenidate
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
Methylphenidate 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 methylphenidate. Monitoring should be at every
adjustment of dose and then at least every 6 months or every visit.
Shared Care Guideline April 2013
7
Cautions cont.
Seizures
Methylphenidate should be used with caution in patients with epilepsy. Methylphenidate
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
new-onset seizures occur, methylphenidate should be discontinued.
Abuse, misuse and diversion
Patients should be carefully monitored for the risk of diversion, misuse and abuse of
methylphenidate.
Methylphenidate 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 methylphenidate can lead to marked tolerance and psychological
dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can
occur, especially in response to parenteral abuse.
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, methylphenidate 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.
4.3 Common Side Effects
Frequency estimate: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥
1/1000 to <1/100) rare (≥ 1/10,000 to <1/1000) very rare (< 1/10,000) not known
(cannot be estimated from available data)
Infections and infestations
Common: Nasopharyngitis
Blood and lymphatic disorders
Shared Care Guideline April 2013
Very rare: Anaemia, leucopenia, thrombocytopenia,
thrombocytopenic purpura
8
Unknown: Pancytopenia
4.4 Common Side Effects
Frequency estimate: very common (≥ 1/10) common (≥ 1/100 to < 1/10)
Infections and infestations
Common: Nasopharyngitis
Metabolism and nutritional disorders *
Common: anorexia, decreased appetite, moderately reduced weight and height gain
during prolonged use in children
Psychiatric disorders *
Very common: insomnia, nervousness
Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*,
irritability, abnormal behaviour
Cases of abuse and dependence have been described, more often with immediate
release formulations (frequency not known)
Nervous system disorders:
Very common: Headache
Common:, Dizziness, dyskinesia, psychomotor hyperactivity, somnolence
Cardiac disorders
Common: Arrhythmia, tachycardia palpitations
Vascular disorders
Common: Hypertension
Respiratory, thoracic and mediastinal disorders
Common: Cough, pharyngolaryngeal pain
Gastro-intestinal disorders:
Common: Abdominal pain, diarrhoea, nausea, stomach discomfort and vomiting. These
usually occur at the beginning of treatment and may be alleviated by concomitant food
intake. Dry mouth.
Skin and subcutaneous tissue disorders
Common: Alopecia, pruritis, rash, urticaria
Musculoskeletal, connective tissue and bone disorders
Common: Arthralgia
General disorders and administration site conditions
Common: Pyrexia, growth retardation during prolonged use in children*
Investigations
Common: Changes in blood pressure and heart rate (usually an increase)*, weight
decreased*
Shared Care Guideline April 2013
9
4.5 Drug Interactions
Anti-hypertensive drugs
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Use with drugs that elevate blood pressure
Caution is advised in patients being treated with methylphenidate with other drugs that can
also elevate blood pressure (see also sections on cardiovascular and cerebrovascular
conditions in section 4.4 Warnings and precautions for use).
Because of possible hypertensive crisis, methylphenidate is contraindicated in patients
being treated (currently or within the preceding 2 weeks) with non-selective, irreversible
MAO-inhibitors (see section 4.3 Contraindications).
Use with alcohol
Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including
methylphenidate. It is therefore advisable for patients to abstain from alcohol during
treatment
Use with halogenated anaesthetics
There is a risk of sudden blood pressure increase during surgery. If surgery is planned,
methylphenidate treatment should not be used on the day of surgery.
Use with centrally acting alpha-2agonists (e.g. clonidine)
The long term safety of using methylphenidate in combination with clonidine or other
centrally acting alpha-2 agonists has not been systematically evaluated.
Use with dopaminergic drugs
Caution is recommended when administering methylphenidate with dopaminergic drugs,
including antipsychotics. Because a predominant action of methylphenidate is to increase
extra cellular dopamine levels, methylphenidate may be associated with
pharmacodynamic interactions when co-administered with direct and indirect dopamine
agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists
including antipsychotics.
Shared Care Guideline April 2013
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4.6 Routine Monitoring
Initial
Weight BP and Pulse
Ongoing
BP and Pulse every 3 months and after dose change
Monitoring for tics, seizures, psychiatric problems at 6 every months and after dose
change
Monitoring for ADR’s
4.7 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.
Shared Care Guideline April 2013
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 an effective acceptable 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 and raising any concerns re mental health.
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
who will stop the prescriptions
6 RESPONSIBILITY OF NURSE (if applicable)
Shared Care Guideline April 2013
12
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 an 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 of BP and pulse, 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) CG72 National Institute for Health and Clinical Excellence: Attention deficit
hyperactivity disorder: Diagnosis and management of ADHD in children, young
people and adults
Shared Care Guideline April 2013
13
ADHD Diagnostic Assessment Clinic
Arthur Webster Clinic
35 Landguard Manor Road
Shanklin
Isle of Wight
PO37 57HZ
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.
Methylphenidate 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
Shared Care Guideline April 2013
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
Dr
Practice address
Shared Care Guideline April 2013
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
Protected Groups
Age
Gender Reassignment
Race
Sex and Sexual Orientation
Religion or belief
Disability
Marriage and Civil
Partnerships
Human Rights
Pregnancy and Maternity
20
Service
Users
Staff
Wider Community
y
Page 16 of
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
Page 18 of 19
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
http://www.equalityhumanrights.com/advice-and-guidance/new-equality-actguidance/equality-act-guidance-downloads/
Page 19 of 19