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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. MODA 08 fnl 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. MODA 08 fnl 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. MODA 08 fnl 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 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. MODA 08 fnl 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. MODA 08 fnl 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 MODA 08 fnl