Modafinil Shared Care Guideline - the Royal Cornwall Hospitals ...

Version Control TableDateVersionNoMay 2011 V1.0Summary of ChangesFinal amendments approved; EIACompleted; document publishedChanges Made by(Name and Job Title)Mike Wilcock, Head ofPrescribing SupportUnit, PharmacyDepartment, RCHTAll or part of this document can be released under the Freedom of Information Act2000This document is to be retained for 10 years from the date of expiry.

CORNWALL AND IOS HEALTH COMMUNITY SHARED CARE GUIDELINEMODAFINILThis shared care guideline sets out details for sharing careof adult patients prescribed Modafinil. These guidelinesprovide limited information necessary to aid in thetreatment of these patients. As with all shared careguidelines they highlight relevant prescribing issues butshould be used in conjunction with the BNF, ABPIsummary of product characteristics and do not replacethem.BACKGROUND / INDICATIONS FOR THE PURPOSESOF THIS GUIDELINE:Modafinil is licensed for adults for the treatment ofexcessive sleepiness associated with narcolepsy with orwithout cataplexy. Excessive sleepiness is defined asdifficulty maintaining wakefulness and an increasedlikelihood of falling asleep in inappropriate situationsA diagnosis of narcolepsy should be made according tothe International Classification of Sleep Disordersguideline. Such an evaluation usually consists, in additionto the patient's history, sleep measurements testing in alaboratory setting and exclusion of other possible causesof the observed hypersomnia.Modafinil, in similar dosages to those below, is also usedoff-license for: the hypersomnia that may occasionally be seenin chronic fatigue syndrome (CFS/ME),sleepiness and fatigue associated with multiplesclerosis, sleepiness associated with myotonic dystrophy (acommon form of adult muscular dystrophy). and sleepiness associated with idiopathichypersomnolence (debilitating sleepinessthroughout the day without a diagnosed medicalreason).Note that modafinil is no longer indicated for shift-workersleep disorder and obstructive sleep apnoea.Narcolepsy is a rare (1: 50,000) disorder of sleep. It isneurological disorder marked by uncontrollable attacks ofdaytime sleepiness and also quite often characterised bycataplexy (sudden loss of muscle power triggered byemotion).The sleep pattern typically seen in CFS/ME is of poorquality, disrupted and unrefreshing night-time sleep, whichmay lead to compensatory day time sleeping; usualapproaches to improving night-time sleep (sleep hygiene;low-dose tricyclics or related agents) are indicated, andmodafinil is not appropriate in this setting. However, avery few CFS/ME patients have disabling hypersomnia,despite good night-time sleep; it is for these patients thatmodafinil may be considered, as it has proved helpful andwell tolerated in clinical experience. A starting dose of100mg in the morning is appropriate, as some CFS/MEpatients may be more sensitive to the effects ofmedication.DOSAGETreatment should be initiated by or under the supervisionof a physician with appropriate knowledge of indicateddisorders.The recommended starting dose is 200mg a day, or100mg a day for CFS/ME patients. The total daily dosemay be taken as a single dose in the morning or as twodoses in the morning and at noon, according to physicianassessment of the patient and the patient's response.Doses of up to 400mg in one or two divided doses can beused in patients with insufficient response to the initialmodafinil dose.Doses should be halved in patients with severe hepatic orrenal failure (100 – 200mg / day).INITIATION & MONITORINGA baseline electrocardiogram should be done beforetreatment initiation. Patients with abnormal findings shouldbe further evaluated by specialists before modafiniltreatment can be initiatedCardiovascular function—especially blood pressure andheart rate—should be monitored after one to two monthsof treatment, and then regularly annually, or morefrequently if there are significant risk factors. Modafinilshould be discontinued in patients who developarrhythmia or moderate to severe hypertension, andshould not be restarted until the condition has beenadequately evaluated and treated.CONTRAINDICATIONSPregnancy and breast feeding; use in children;uncontrolled moderate to severe hypertension and inpatients with cardiac arrhythmias; patients with a history ofleft ventricular hypertrophy or cor pulmonale; and inpatients with mitral valve prolapse who have experiencedthe mitral valve prolapse syndrome when previouslyreceiving CNS stimulants.PRECAUTIONS - caution is advised as follows:Patients with major anxiety should only receive treatmentin a specialist unit.Modafinil should be used with caution in patients with ahistory of: Psychosis, depression, or maniaModafinil SCG Page 1 of 3Authors: Neurology Team. Endorsed by Cornwall & IoS Prescribing CommitteeDate of Issue: May 2011 Review Date June 2014

CORNWALL & IOS HEALTH COMMUNITY SHARED CARE GUIDELINE Abuse of alcohol, drugs, or illicit substancesSuch patients should be monitored closely and advised toreport any suspected adverse behaviours or thoughts.These patients should be assessed immediately andtreatment stopped if appropriate.Modafinil should be discontinued and not restarted incases of psychiatric disorders such as suicidal ideation.Sexually active women of childbearing potential should beestablished on a contraceptive programme before takingmodafinil.Whilst studies with modafinil have demonstrated a lowpotential for dependence, the possibility of dependencewith long-term use cannot be entirely excluded.Serious rash, including Stevens-Johnson Syndrome, ToxicEpidermal Necrolysis and Drug Rash with Eosinophiliaand Systemic Symptoms: Serious skin rashes requiringhospitalization and discontinuation of treatment have beenreported in adults and children in association with the useof modafinil occurring within 1 to 5 weeks after treatmentinitiation [isolated cases have been reported afterprolonged treatment (e.g. 3 months)]. Modafinil should bediscontinued at the first sign of rash and not restartedunless the rash is clearly not drug – relatedSIDE EFFECTSBelow are some of the more common side effects. Pleasenote that this list is NOT exhaustive and that it isrecommended that the SPC and BNF should be consultedfor a more comprehensive list:: - decreased appetite,nervousness, insomnia, anxiety, depression, abnormalthinking, confusion, headache, dizziness, somnolence,paraesthesia, blurred vision, tachycardia, palpitation,vasodilatation, abdominal pain, nausea, dry mouth,diarrhoea, dyspepsia, constipation, asthenia. Patients withexcessive sleepiness, including those taking modafinilshould be frequently reassessed for their degree ofsleepiness and, if appropriate, advised to avoid driving orany other potentially dangerous activity.COMMON / SIGNIFICANT DRUG INTERACTIONSThere is a low potential for drug-drug interactions. TheSPC and BNF should be consulted for a morecomprehensive list of potential drug interactions.Modafinil accelerates the metabolism of oralcontraceptives leading to reduced contraceptiveeffectiveness hence alternative or concomitant methods ofcontraception are recommended. Adequate contraceptionwill require continuation of these methods for two monthsafter stopping modafinilIn view of the enzyme inducing potential of modafinil, careshould be taken when co-administering with anticonvulsants.The clearance of warfarin may be decreased –prothombin times should be monitored regularly during thefirst two months and after changes in modafinil dosage.Blood levels of ciclosporin may be reducedPRODUCT INFORMATIONModafinil (Provigil) is available as a 100mg and 200mgtablets.REFERENCES Summary of Product Characteristicshttp://emc.medicines.org.uk/ British National Formulary www.bnf.org.ukCONTACTS (in hours) RCHT medicine information: 01872 252587Request for otherformatsPlease ask if you wouldlike to receive this leafletin large print, braille, onCD or in any otherlanguages. If you wouldlike the leaflet in analternative format pleasecontact the PALS team onpalsteam@ciospct.cornwall.nhs.uk or 0845 1708000Modafinil SCG Page 2 of 3Authors: Neurology Team. Endorsed by Cornwall & IoS Prescribing CommitteeDate of Issue: May 2011 Review Date: June 2014

CORNWALL & IOS HEALTH COMMUNITY SHARED CARE GUIDELINEAREAS OF RESPONSIBILITY FOR THE SHARING OF CAREThese are suggested ways in which the responsibilities for adult patients prescribed Modafinil can be sharedbetween the specialist and the general practitioners. GPs are invited to participate. An endorsement of a SCGby the CIPC means that prescribing in accordance with the SCG is suitable for primary care to undertake. If theGP is not confident to undertake these roles, then they are under no obligation to do so. In such an event thetotal clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialistasks the GP to prescribe this drug the GP should reply to this request as soon as practical. Sharing of careassumes communication between the specialist, GP and patient. The intention to share care should beexplained to the patient and be accepted by them.In its guidelines on responsibility for prescribing (circular EL(91)127) between hospitals and GPs, theDH has advised that legal responsibility for prescribing lies with the doctor who signs the prescription.Specialist: To assess the patient and establish/confirm the diagnosis of hypersomnia, ensuring the suitability of thepatient for modafinil. To undertake or arrange a baseline electrocardiogram before treatment initiation. Patients with abnormalfindings should be further evaluated by specialists before modafinil treatment can be initiated. Prescribe modafinil until GP formally agrees to shared care, then transfer prescribing ensuring patient has4 weeks supply. Review of treatment to assess benefit eg an annual review by a Consultant Sleep Specialist, after GP hastaken over the prescribing. Stop treatment at any appropriate time. Ensure clear arrangements for back-up advice and support. Reporting adverse events to the MHRA.General Practitioner: Reply to request for shared care as soon as practical. Prescribing following stabilisation of patient Monitoring of BP and heart rate in hypertensive patients after one to two months of treatment, and thenregularly annually, or more frequently if there are significant risk factors. Discontinue in patients who experience any psychiatric symptoms and not restart. Discontinue at the first sign of rash and not restart. Monitoring patient’s overall health and well-being. Monitoring adverse effects and potential drug interactions and reporting to specialist as appropriate. Reporting adverse events to MHRA. Stopping treatment in the case of a severe adverse event or as per shared care guideline.Patient: Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should bemaintained. Report any adverse effects to their GP and/or specialist whilst being treated with modafinil.BACK-UP ADVICE AND SUPPORT IS AVAILABLE FROM THE RELEVANT TEAMModafinil SCG Page 3 of 3Authors: Neurology Team. Endorsed by Cornwall & IoS Prescribing CommitteeDate of Issue: May 2011 Review Date: June 2014

Appendix 1.Initial Equality Impact Assessment Screening FormName of service, strategy, policy or project (hereafter referred to as policy) to beassessed:Shared Care Guideline for ModafinilDirectorate and service area:Is this a new or existing Procedure?PharmacyNewName of individual completingTelephone:assessment:Dan Thomas, Pharmaceutical Services 01726 627514Contracting Manager, CIoSPCT1. Procedure Aim* To provide information on prescribing of Modafinil toenable General Practitioners to take over prescribingresponsibility from secondary care.2. Procedure Objectives* To promote a consistent level of shared care betweenprimary and secondary care (in relation to RCHTcatchment area)3. Procedure – intendedOutcomes*Confident and competent prescribers, enabling medicinesto be access in a primary care setting.4. How will you measurethe outcome?5. Who is intended tobenefit from theProcedure?6a. Is consultationrequired with theworkforce, equalitygroups etc. around thisprocedure?If the guidelines is not well received, publicised andadopted, then some GPs may not enter into shared carearrangements.General practitioners, hospital specialists and communitypharmacists – from understanding local guidance arounduse of these medicines. Patients/carers, from being ableto access medicines from their GP.NOb. If yes, have thesegroups been consulted?c. Please list any groupswho have been consultedabout this procedure.*Please see Glossary7. The ImpactPlease complete the following table using ticks. You should refer to the EIA guidancenotes for areas of possible impact and also the Glossary if needed.

Where you think that the policy could have a positive impact on any of the equalitygroup(s) like promoting equality and equal opportunities or improving relationswithin equality groups, tick the ‘Positive impact’ box. Where you think that the policy could have a negative impact on any of the equalitygroup(s) i.e. it could disadvantage them, tick the ‘Negative impact’ box. Where you think that the policy has no impact on any of the equality group(s) listedbelow i.e. it has no effect currently on equality groups, tick the ‘No impact’ box.EqualityGroupAgePositiveImpactNegativeImpactNoImpactxReasons for decisionDisabilityxFaith andBeliefxGenderxRacexSexualOrientationxYou will need to continue to a full Equality Impact Assessment if the following havebeen highlighted: A negative impact and No consultation (this excludes any policies which have been identified as notrequiring consultation).8. If there is no evidence thatthe policy promotes equality,equal opportunities or improvedrelations - could it be adaptedso that it does? How?Full statement of commitment to policy ofequal opportunities is included in the policyPlease sign and date this form.Keep one copy and send a copy to the Human Resources Team, c/oRoyal Cornwall Hospitals NHS Trust, Human Resources Department, Lamorna House,Penventinnie Lane, Truro, Cornwall, TR1 3LJThey willarrange for a summary of the results to be published on the Trust’s web site.Signed _______Dan Thomas & Mike Wilcock_________________________________Date _____April 2011____________________________________