Download Modafinil - NHS Trafford CCG

GREATER MANCHESTER INTERFACE
PRESCRIBING GROUP
On behalf of the
GREATER MANCHESTER MEDICINES MANAGEMENT
GROUP
SHARED CARE GUIDELINE for Modafinil
Scope: for the treatment of excessive sleepiness associated
with narcolepsy & obstructive sleep apnoea syndrome.
Reference Number
MODA 08 fnl
Classification
SHARED CARE GUIDELINE
Issue date: April 2008
Replaces: No previous document available
Author(s)/Originator(s)
Emma Rutherford, Clinical Pharmacist for
Neurology, Salford Primary Care Trust & Salford
Royal NHS Foundation Trust
Pharmaceutical company’s patient information
leaflet (PIL)
Summary of product characteristics (SPC)
Interface Prescribing Group
Date
April 2010
To be read in conjunction with the
following documents
Authorised by
Review Date
1. Introduction
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is the most
common cause of excessive daytime sleepiness and affects up to 4% of
adults. Poor concentration and mood changes significantly impair quality
of life, and sleepiness increases the risk of motor vehicle accidents some
7–12 times. Obstructive sleep apnoea/hypopnoea syndrome predisposes
to hypertension, and treatment contributes to prevention of myocardial
infarction and stroke.
Modafinil acts on the central nervous system, although the mechanism for
its effect is unknown. It is first-line adjunctive therapy for the treatment of
excessive daytime sleepiness that persists in patients with OSAHS despite
an adequate response to CPAP therapy (1).
Narcolepsy is a lifelong disorder of the central nervous system
characterised by uncontrollable daytime sleepiness (also called 'excessive
daytime sleepiness') and intermittent abnormal manifestations of rapid eye
movement (REM) sleep during wake or sleep-wake transition, of which
cataplexy is the most prominent (2).
2. Scope
This shared care protocol must be adhered to by all medical, nursing,
pharmacy and other staff who are involved in the care of patients who are
suitable for shared care, as agreed by both the GP and hospital specialist
caring for the patient.
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3. Clinical condition being treated
The use of stimulant drugs to control excessive daytime sleepiness in
narcolepsy has been proposed since 1931 and it is still the recommended
first-line intervention (3). Stimulant drugs are classically divided into directacting sympathomimetic drugs, indirect-acting sympathomimetic drugs or
stimulants with some other way of action and modafinil falls into this latter
category.
4. Product information and treatment regimen to be used
Modafinil is available as 100mg or 200mg tablets (4).
Narcolepsy and obstructive sleep apnoea syndrome:
The recommended daily dose is 200-400 mg, commencing at 200 mg and
titrated according to clinical response. Modafinil may be taken as two
divided doses in the morning and at noon, or as a single dose in the
morning, according to physician assessment of the patient and the
patient's response. In elderly patients the initial dose should be 100mg
daily. The maximum dose of 400mg daily should only be used in the
absence of hepatic or renal impairment.
Treatment should be initiated by or under the supervision of a physician
with appropriate knowledge of relevant sleep disorders3.
5. Regimen Management
a) Aspects of care for which the Consultant is responsible
o Assessing the need for treatment
o Confirming with GP the use of the Shared Care Protocol
o Prescribing medication until maintenance regimen established
o Evaluating any adverse events noted by GP or patient
o Advising GP on change of, or discontinuation, of therapy
o Overall monitoring of disease status and efficacy of treatment
b) Conditions of assuming responsibility by the GP
This shared care agreement outlines suggested ways in which the
responsibilities for managing the prescribing of modafinil can be shared
between the specialist and general practitioner (GP). GPs are invited
to participate. If the GP is not confident to undertake these roles, then
he or she is under no obligation to do so. In such an event, the total
clinical responsibility for the patient for the diagnosed condition remains
with the specialist.
If a specialist asks the GP to prescribe this drug, the GP should
reply to this request as soon as possible.
Sharing of care assumes communication between the specialist, GP
and patient. The intention to share care should be explained to the
patient by the doctor initiating treatment. It is important that patients
are consulted about treatment and are in agreement with it.
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c) Aspects of care for which the GP is responsible
o Reply to the request for shared care as soon as practicable
o Prescribe modafinil once treatment regime has been stabilised.
o Monitor patient’s response to treatment; make dosage
adjustments if agreed with specialist.
o Monitor blood pressure and heart rate in hypertensive patients.
o Report to and seek advice from the specialist on any aspect of
patient care that is of concern to the GP and may affect
treatment.
o Refer back to specialist if condition deteriorates.
o Report adverse events to specialist and CSM
o Discontinue in patients who experience any psychiatric
symptoms and not restarted
o Discontinue at the first sign of rash and not restarted
o Stop treatment on advice of specialist.
Individual consideration of each case between consultant and GP
GPs will receive detailed information from the hospital team on the
required prescription changes and any relevant details concerning the
patient’s condition.
6. Summary of cautions, contra indications, side-effects
For full details refer to Summary of Product Characteristics (SPC) for
Modafinil
Side Effects
The most commonly reported adverse drug reaction is headache, affecting
~21% of patients. This is usually mild or moderate, dose-dependent and
disappears within a few days.
Other common (1-10%) side effects: abnormal liver function tests (dose
related increases in alkaline phosphatase and gamma glutamyl
transferase have been observed), tachycardia, palpitation, dizziness,
somnolence, paraesthesia, blurred vision, abdominal pain, nausea, dry
mouth, diarrhoea, dyspepsia, constipation, decreased appetite,
vasodilatation, asthenia, chest pain, nervousness, insomnia, anxiety,
depression, abnormal thinking, confusion
Serious skin reactions
Stevens Johnson Syndrome, erythema multiforme, and toxic epidermal
necrolysis have been reported in association with modafinil. These
conditions usually occurred within the first 5 weeks of treatment, although
there have been isolated cases after more than 3 months’ treatment. In
clinical trials, the risk of rash resulting in discontinuation of modafinil
treatment was higher in children than adults (0·8% vs no cases). Modafinil
is not authorised for use in children.
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Psychiatric symptoms
Suicidal ideation, hallucinations, delusion, aggression, psychosis, and
mania have been reported in association with modafinil. These reactions
have occurred mainly, but not exclusively, in patients with a history of
psychosis, depression, or mania. Modafinil: serious skin reactions,
hypersensitivity, and psychiatric symptoms
Modafinil should be withdrawn in patients who experience a rash or
psychiatric symptoms
Advice for healthcare professionals:
• Modafinil should be discontinued at the first sign of rash and not restarted
• Modafinil should be discontinued in patients who experience any
psychiatric symptoms and not restarted
• Modafinil should be used with caution in patients with a history of
psychosis, depression, or mania
• Modafinil should be used with caution in patients with a history of alcohol,
drug, or illicit substance abuse
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Contraindications
Known sensitivity to the drug or excipients
During pregnancy and lactation
In patients with uncontrolled moderate to severe hypertension or
arrhythmia.
It is recommended that PROVIGIL tablets not be used in patients with a
history of left ventricular hypertrophy or cor pulmonale. PROVIGIL should
not be used in patients with mitral valve prolapse who have experienced
the mitral valve prolapse syndrome when previously receiving CNS
stimulants.
- For full details refer to Summary of Product Characteristics (SPC) for
Modafinil
Drug Interactions
Anticonvulsants, Steroidal contraceptives, Antidepressants,
Anticoagulants, Ciclosporin
7. Special considerations
No ancillary products or apparatus are required from the G.P.
8. Back-up care available to GP from Hospital, including emergency
contact procedures and help line numbers
Further information and support is available from the following contacts:
Acute Neurology Ward, Hope Hospital
Phone: 0161 206 4586
Open seven days a week.
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Department of Respiratory Medicine, Hope Hospital
Phone 0161 206 5155
Pharmacy Medicines Information Phone: 0161 206 5223
Between 9am and 5pm Monday to Friday
Outside these hours the neurology or medical registrar on call may be
contacted through switchboard for advice.
For specific medicines information out of hours the on-call pharmacist can
be contacted through the hospital switchboard.
9. Statement of agreement
Shared care is an agreement between the GP and the Consultant. This
form is a request by the consultant to share the suggested care pathway of
your patient. If you are unable to agree to the sharing of care and initiating
the suggested medication, please make this known to the consultant within
14 days, ideally stating the nature of your concern.
Policy Statement
The NHS Management Executive issued guidance in 1991 (Responsibility
for prescribing between hospitals and GPs EL(91)127) and 1994
(Purchasing and prescribing EL(94)72), which reinforced the basic
premise that the doctor who has clinical responsibility for a patient should
undertake prescribing. However if it is considered that it is in the best
interests of the patient that care is to be shared between primary care and
the hospital, there should be proper hand-over procedures from hospital
specialists to GPs.
The purpose of this shared care protocol is to align clinical and prescribing
responsibility in order to enhance patient safety by ensuring that the
individual signing prescriptions will also be responsible for ensuring that
any necessary monitoring has been undertaken and will have access to
the results of this.
10. Written information provided to the patient
Product patient information leaflets are available online for modafinil at the
Electronic Medicines Compendium http://emc.medicines.org.uk/
This shared care protocol will be reviewed on a two-yearly basis or in the
intervening period if new research is published that means an update is
required before two years has passed.
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11. Supporting References
1. Black JE; Hirshkowitz M. Modafinil for treatment of residual excessive
sleepiness in nasal continuous positive airway pressure-treated
obstructive sleep apnea/hypopnea syndrome. Sleep 2005 Apr
1;28(4):464-71
2. Vignatelli L, Casmiro M, Lombardi C, Plazzi G, D'Alessandro R.
Stimulant drugs for narcolepsy in adults. (Protocol) The Cochrane
Database of Systematic Reviews 2005, Issue 4
3. Littner M, Johnson SF, McCall WV, Anderson WM, Davila D, Hartse K,
et al. Practice parameters for the treatment of narcolepsy: an update
for 2000. Sleep 2001;24(4):451-66.
4. Summary of Product Characteristics. Provigil®- Cephalon UK Ltd.
Revised May 2006. Available online at: www.emc.medicines.org.uk
5. Interaction data available from Stockley. Online at
www.medicinescomplete.com
6. Modafinil Micromedex
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