MIGRAINE IN PRIMARY CARE ADVISORS Development of pharmacist guidelines for migraine management

Overview Review of the MIPCA guidelines for migraine management Customisation of the MIPCA guidelines to produce pharmacy guidelines Discussion of prescription-only acute migraine drugs (POM) switching to pharmacy prescription (P) Affiliation of MIPCA with the RPS

The MIPCA guidelines for migraine management in primary care

Diagnosis Assess severity Treatment plan Screen for headache type Differentiate migraine from other headaches Attack frequency and pain severity Impact on patient’s life (MIDAS / HIT) Non-headache symptoms Patient factors Establish goals Behavioural therapy Acute therapy Possible prophylactic therapy Complementary therapy? Consultation Specific consultation Treatment history Patient education, counselling and commitment Follow-up Assess outcome of therapy Management individualised for each patient Overall diagram for migraine management

Processes First consultation –Screening –Patient education and commitment –Diagnosis –Assessment of illness severity –Tailoring management to the needs of the individual patient –Prescribe only treatments that have evidence base for effectiveness Pro-active long-term follow up –Monitor success of therapy and modify treatment if necessary Team approach to care Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Screening procedures Taking a careful history is essential –Use of a headache history questionnaire is recommended Patient education –Advice, leaflets, websites and patient organisations Patient commitment –Patients to take charge of their own management –Effective communication between patient and physician Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Headache diagnosis MIPCA proposal: a simple screening questionnaire to distinguish between common headache subtypes Hypothesis: any episodic, high-impact headache can be given a default diagnosis of migraine Dowson AJ et al. Headache Care 2004;1:137-9

Four-item questionnaire A.Exclude sinister headaches New-onset, acute headaches associated with other symptoms –e.g. rash, neurological deficit, vomiting, pain/tenderness, accident/head injury, infection, hypertension –Neurological change/deficit does not disappear when the patient is pain-free between attacks Dowson AJ et al. IJCP 2003;57:

Four-item questionnaire 1.What is the impact of the headache on the sufferer’s daily life? (screens for migraine/chronic headaches and episodic TTH) Impact questionnaires, e.g. MIDAS or HIT, are useful Dowson A. Curr Med Res Opin 2001;17:

Four-item questionnaire 2.How many days of headache does the patient have every month? (screens for migraine and chronic headaches) > 15 = chronic headaches  15 = migraine Headache Classification Committee of the IHS. Cephalalgia 2004;24 (Suppl 1):1-160

Four-item questionnaire B.Consider short-lasting chronic headaches 15 min - 3 hours may be cluster headache Dowson AJ, Cady RC. Rapid Reference to Migraine 2002

Four-item questionnaire 3.For patients with chronic daily headache, on how many days per week does the patient take symptomatic medication? (screens for medication*-dependent headaches)  2 = medication dependent < 2 = not medication dependent * analgesics, ergots and triptans Silberstein SD, Lipton RB. Curr Opin Neurol 2000;13: Olesen J. BMJ 1995;310:479-80

Four-item questionnaire 4.For patients with migraine, does the patient experience reversible sensory symptoms associated with their attacks? (screens for migraine with aura and migraine without aura) Headache Classification Committee of the IHS. Cephalalgia 2004;24 (Suppl 1):1-160

Patient presenting with headache Migraine/CDH low High Q1. What is the impact of the headache on the sufferer’s daily life? ETTH (40-60%) Q2. How many days of headache does the patient have every month? > 15  15 CDH (5%) Q3. For patients with chronic daily headache, on how may days per week does the patient take symptomatic medications? <2 22 Not medication dependent Medication dependent Migraine (10-12%) Q4. For patients with migraine, does the patient experience reversible sensory symptoms associated with their attacks? With aura Without aura YesNo Exclude sinister Headache (<1%) Consider short-lasting Headaches (<1%) Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Management individualised for each patient Assess illness severity Attack frequency and duration Pain severity Impact on daily living –MIDAS/HIT questionnaires Non-headache symptoms Patient factors –History, preference and other illnesses Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Assessment of severity Mild-to-moderate migraineModerate-to-severe migraine Headaches mild-to- moderate in intensity Headaches moderate or severe in intensity Non-headache symptoms not severe in intensity Significant non-headache symptoms, possibly severe Low headache impact: MIDAS Grade I or II HIT Grade 1 or 2 High headache impact: MIDAS Grade III or IV HIT Grade 3 or 4 Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Provision of treatment plan tailored to the individual’s needs Evidence-based medicine (Duke database) suggests: Behavioural therapy recommended for all Acute therapy recommended for all Prophylactic therapy recommended for certain patients Complementary therapies may be useful as adjunctive therapy Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Individualising care – behavioural and physical therapy Duke recommended therapies Behavioural: –Biofeedback and relaxation –Stress reduction –Avoidance of triggers –Food restriction diets? Physical –Cervical manipulation –Massage –Exercise Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Individualising care – acute medications Goals: to rapidly relieve the headache and other symptoms, and permit the return to normal activities within 2 hours Acute medications should be provided for all patients Strategy: individualised care, patients have a portfolio of medications to treat attacks of differing severities, and have access to rescue medications if the initial therapy fails Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Tailored care for migraine Migraine diagnosis Severity assessment Mild to moderate migraineModerate to severe migraine Initial therapy Rescue If unsuccessful Migraine attack Dowson AJ et al Int J Clin Pract 2003;57: Stratified care Staged care

Acute medications: Duke recommended treatments (UK) Mild-to-moderate migraine Initial therapies –Paracetamol, Aspirin or NSAIDs (high doses) –Aspirin/paracetamol plus anti-emetics –Use if possible before headache starts Rescue medications –Oral triptans –Use for any headache severity Silberstein SD et al. Neurology 2000;

Acute medications: Duke recommended treatments (UK) Moderate-to-severe migraine Initial therapies –Oral triptans (tablet/ODT) –Use after the headache starts, if possible when it is mild in intensity Rescue medications –Second dose, alternative oral triptan, nasal spray or subcutaneous triptans –Symptom control Issues with triptans: cost, safety and tolerance Silberstein SD et al. Neurology 2000;

Assess migraine severity  Impact  Attack frequency and duration  Pain severity  Non-headache symptoms  Patient history and preferences Intermittent Mild-to-moderate Intermittent Moderate to severe Behavioural therapy Analgesic-based therapies Behavioural therapy Appropriate triptan Second dose / alternative formulation triptan Symptomatic treatment Initial treatment Rescue Behavioural therapy Analgesic-based therapies Behavioural therapy Appropriate triptan Prophylaxis / Referral Success Failure Success Failure Evaluation Follow-up treatment Rescue Lipscombe S et al. Headache Care 2004;1:147-57

Rescue and follow-up medications Initial medicationRescue or follow-up medications Analgesic-based medicationsTry a second dose Triptan tablets* Oral triptans*Try a second dose Alternative triptan tablets Nasal spray or sc triptan Nasal spray triptanTry a second dose sc sumatriptan Try a second dose Symptomatic treatment * Conventional tablet or ODT Lipscombe S et al. Headache Care 2004;1:147-57

Caveats on triptan use Most patients are effectively treated with an oral triptan –Differences between the oral triptans are small and of uncertain clinical significance Patients with unpredictable or fast-onset attacks may benefit from ODT or nasal spray formulations Patients with severe attacks and/or with vomiting may benefit from nasal spray or subcutaneous formulations Subcutaneous sumatriptan is an effective rescue medication Beware contraindications (age; pregnancy; heart disease) Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Individualising care – prophylactic medications Goals: to reduce headache frequency by >50% Prophylactic medications should be provided: –For patients with frequent, high-impact migraine attacks (  4/month) –Where acute medications are ineffective or precluded by safety concerns –For patients who overuse acute medications and/or have CDH However: acute medications should also be provided for breakthrough attacks Silberstein SD et al. Neurology 2000; Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Prophylactic medications: Duke recommended treatments (UK) First-line medications: –Beta-blockers (propranolol, metoprolol, timolol, nadolol) –Anticonvulsants (topiramate, valproate*) –Antidepressants* (amitriptyline) Second-line medications –Serotonin antagonists (pizotifen, methysergide, cyproheptadine) –Poor efficacy / high side effects * Not licensed for migraine in the UK Silberstein SD et al. Neurology 2000;

Individualising care – complementary therapies Effective therapies Feverfew* Magnesium* Vitamin B2* Butterbur* Acupuncture* Low-dose aspirin* However: use only accredited complementary practitioners * Not licensed for migraine in the UK Dowson AJ, Cady RC. Rapid Reference to Migraine 2002

Assess migraine severity  Impact  Attack frequency and duration  Pain severity  Non-headache symptoms  Patient history and preferences Intermittent attacks Frequent attacks Acute treatmentsProphylaxis Initial treatment Acute treatments Try second prophylactic drug Refer Evaluation Follow-up treatment Treat for ≤ 6 months Taper / withdraw Suspect CDH SuccessFailure Lipscombe S et al. Headache Care 2004;1:147-57

Follow-up procedures Instigate proactive long-term follow-up procedures Monitor the outcome of therapy –Headache diaries –Impact questionnaires (MIDAS/HIT) Make appropriate treatment decisions Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Follow-up treatment decisions Acute medications –Patients effectively treated should continue with the original therapy –Patients who fail on original therapy should be offered other therapies Prophylactic medications –Ensure medication is provided for an adequate time period at an adequate dose (up to 3 months) –If effective, treatment can continue for 6 months, after which it may be stopped –If ineffective, another prophylactic medication may be tried –Usual contraindications apply Patients refractory to repeated acute and prophylactic medications should be referred to a specialist Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Implementation of guidelines Primary care headache team –GP, practice nurse, ancillary staff and practice pharmacist (core team) –Community pharmacist –Community nurses –Optician –Dentist –Complementary practitioners –Specialist physician (additional resource) –And... The patient Model for NSF in chronic diseases Associate team members Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Pharmacist Community nurse Optician Dentist Complementary practitioner Patient Primary care physician Practice nurse Physician with expertise in headache: GP; PCT; specialist Ancillary staff Primary care Specialist care Associate teamCore team Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

New MIPCA algorithm Initial consultation and treatment

 Detailed history, patient education/commitment  Diagnostic screening and differential diagnosis  Assess illness severity  Attack frequency and duration  Pain severity  Impact (MIDAS or HIT questionnaires)  Non-headache symptoms  Patient history and preferences Intermittent mild-to-moderate migraine (+/- aura) Intermittent moderate-to severe migraine (+/- aura) Paracetamol/Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic Oral triptan 2 nd dose/alternative oral triptan/ Nasal spray/subcutaneous triptan Initial consultation Initial treatment Rescue Behavioural/complementary therapies Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

New MIPCA algorithm Follow-up consultation and treatment

Paracetamol/Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic Oral triptan Initial treatment Follow-up treatment Oral triptan 2 nd dose/Alternative oral triptan Nasal spray/sc triptan/ Symptomatic Rescue If unsuccessful Consider prophylaxis + acute treatment for breakthrough migraine attacks Frequent headache (i.e.  4 attacks per month) Consider referral Chronic daily headache (CDH)? Migraine If unsuccessful Initial treatment Copyright MIPCA 2002, all rights reserved If management unsuccessful Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

‘10 Commandments’ of headache management

Screening/diagnosis 1.Almost all headaches are benign and should be managed in general practice (However, monitor for sinister headaches and refer if necessary) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

2.Use questions / a questionnaire assessing impact on daily living for diagnostic screening and to aid management decisions (Any episodic, high impact headache should be given a default diagnosis of migraine) Screening/diagnosis Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Management 3.Share migraine management between the doctor and the patient (The patient taking control of their management and the doctor providing education and guidance) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Management 4.Provide individualised care for migraine and encourage patients to treat themselves (Assess migraine severity: Migraine attacks should be divided into mild-to-moderate and moderate-to- severe intensity on the basis of impact and symptom intensity) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Management 5.Follow-up patients, preferably with migraine diaries (Invite the patient to return for further management and apply a proactive policy) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Management 6.Adapt migraine management to changes that occur in the illness and its presentation over the years (e.g. migraine may change to chronic daily headache over time) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Treatments 7.Provide acute medication to all migraine patients and recommend it is taken as early as possible in the attack (Triptans are the most effective acute medications for migraine. Avoid the use of drugs that may cause analgesic-dependent headache, e.g. regular analgesics, codeine and ergotamine) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Treatments 8.Prescribe prophylactic medications to patients who have four or more migraine attacks per month or who are resistant to acute medications (First-line prophylactic medications are beta-blockers, sodium valproate and amitriptyline) Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Treatments 9.Monitor prophylactic therapy regularly Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Treatments 10.Ensure that the patient is comfortable with the treatment recommended and that it is practical for their lifestyle and headache presentation Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Production of pharmacy guidelines for migraine management

Screening and information provision Pharmacists can provide advice, leaflets, and information on websites and patient organisations Take advantage of outputs from MAA and MIPCA Patients may find it easier to talk to the pharmacist than to their GP Role in diagnostic screening –MIPCA / MAA checklist

Role in diagnostic screening MIPCA and MAA have developed a new checklist to aid headache diagnosis –Migraine –TTH –CDH –MOH –Other headaches Aim is to aid diagnosis at first point of medical contact

MIPCA / MAA diagnostic checklist 1.Has the pattern of your headaches been generally stable (i.e. no change or only small changes in frequency and severity) over the past few months? (Yes / No) 2.Have you had headaches for longer than 6 months? (Yes / No) 3.Are you aged between 5 and 50 years? (Yes / No) 4.Does the headache interfere to a noticeable extent with your normal daily life (work, education and social activities)? (Yes / No) 5.On average, how many days with headache do you have per month? (Less than 1 / 1 / 1–4 / 5–15 / 15–30 / Every day) 6.On average, how long do your headaches last? (Less than 15 minutes / 15 minutes to 1 hour / 1–2 hours / 2–4 hours / over 4 hours / My headaches are always there) 7.On average, on how many days per week do you take analgesic medications? (Less than 1 / 1 / Up to 2 / 2 or more / Every day) 8.Do changes in your senses (sight, taste, smell or touch) occur in the period immediately before the headache starts? (Yes / No)

MIPCA / MAA diagnostic checklist 1.Has the pattern of your headaches been generally stable (i.e. no change or only small changes in frequency and severity) over the past few months? (Yes / No) 2.Have you had headaches for longer than 6 months? (Yes / No) 3.Are you aged between 5 and 50 years? (Yes / No) ‘Yes’ = likely benign headache ‘No’ = check for possibility of sinister headache

MIPCA / MAA diagnostic checklist 4.Does the headache interfere to a noticeable extent with your normal daily life (work, education and social activities)? (Yes / No) ‘Yes’ = high impact (i.e. migraine or CDH) ‘No’ = low impact (i.e. TTH)

MIPCA / MAA diagnostic checklist 5.On average, how many days with headache do you have per month? (Less than 1 / 1 / 1–4 / 5–15 / 15–30 / Every day) Up to 15 = episodic headaches (i.e. migraine) Over 15 = chronic headaches (i.e. CDH or cluster)

MIPCA / MAA diagnostic checklist 6.On average, how long do your headaches last? (Less than 15 minutes / 15 minutes to 1 hour / 1–2 hours / 2–4 hours / over 4 hours / My headaches are always there) Under 15 minutes = primary stabbing headache or cluster variants? 15 – 60 minutes = possible cluster headache Over 2 hours = migraine / CDH Constant headaches = CDH

MIPCA / MAA diagnostic checklist 7.On average, on how many days per week do you take analgesic medications? (Less than 1 / 1 / Up to 2 / 2 or more / Every day) Up to 2 = no MOH 2 or more = MOH

MIPCA / MAA diagnostic checklist 8.Do changes in your senses (sight, taste, smell or touch) occur in the period immediately before the headache starts? (Yes / No) ‘Yes’ = migraine with aura ‘No’ = migraine without aura

Checklist validation Study in 80+ headache sufferers completing the checklist Patients completed checklist and diagnosis compared with those from pharmacist, GP and headache specialist (gold standard) Initial results indicate –Diagnosis from checklist was more accurate than that from pharmacist –When pharmacists used the checklist their diagnosis was as accurate as that of the GP

Initial assessment of the patient Obtain diagnosis from the checklist –Possible migraine Ask about illness severity –Mild-to-moderate –Moderate-to-severe Ask about current medications taken Ask about co-morbidities Treatment decision –Provide OTC medications –Recommend GP consultation

Pharmacy algorithm for initial assessment Patient visits pharmacy Completes checklist ETTHMigraine Chronic Headache* Possible sinister Mild-to- moderate Moderate- To-severe Treat with OTC medications Refer to the GP * = CDH, MOH, cluster headache

Pharmacy algorithm for initial assessment Pop-up menus at each stage –Diagnostic checklist –Choice of medications for each diagnosis –Co-morbidities –Drug interactions

Choice of acute medications Only sell migraine medications that have objective evidence of efficacy –Aspirin or Paracetamol (high dose) –NSAIDs (e.g. ibuprofen – high dose) –Combination medications Aspirin / Paracetamol Aspirin / Codeine Aspirin / Paracetamol / Caffeine (Anadin Extra ® ) Paracetamol / Codeine (e.g. Solpadeine, Migraleve) Sumatriptan 50 mg tablets (only to appropriate patients) Recommend: –Take analgesics before the headache starts if possible –Take sumatriptan as early as possible after headache onset (when mild)

Caveats with acute medications Check if the patient has used the drug before –If effective, use again –If ineffective, use another, or refer to GP Check on the patient’s consumption of analgesics –Beware of CDH if current use on ≥ 2 days/week –Warn of dangers of overusing codeine Check on co-morbidities and concurrent medications –Current good practice in pharmacies

Choice of preventive medications Lifestyle options –Stress reduction –Avoidance of triggers Behavioural and physical therapies –Relaxation / biofeedback –Cervical manipulation / acupuncture –Massage / exercise Complementary therapies –Feverfew –Magnesium mg –Vitamin B2 400 mg –Butterbur

Caveats with preventive medications Advise that treatment needs to be taken every day Advise that the patient may not see an improvement for several weeks Check that the patient has acute medications for breakthrough attacks Some complementary medications may not be found in pharmacies, but in health food shops –Education may be required for pharmacists as to appropriate use

Follow up Ask the patient to return after 1 month Check effectiveness of acute medications –Patients effectively treated should continue with the original therapy –Patients who fail on original therapy can be offered other therapies –Refer to GP if analgesics are clearly failing Check effectiveness of preventive medications –Encourage patients to continue with therapy –Refer to GP if treatment is clearly failing And... Be a mentor to the patient after they have consulted with the GP

Switching of acute migraine medications from POM to P status

Context There is currently interest in the possibility of switching some acute migraine medications from POM to P status –Especially the triptans Politicians and the self-medication industry are lobbying for OTC switching –Fuelled by OTC switch of simvastatin in the UK Scrip No. 2960, June ; p 6

Possible drugs involved NSAIDS –Voltarol Rapid –Clotam rapid Analgesic-anti-emetic combinations –Domperamol –Paramax –Migramax Triptan tablets –Not nasal spray or injection formulations

Issues involved - 1 The migraine diagnosis must be confirmed –MIPCA – MAA checklist? –GP diagnosis? The patient should be a ‘typical’ migraine sufferer –Attacks impact on daily activities –Sufferers feel well between attacks –Age range y –Exclude sufferers with frequent attacks (≥ 4 per month)

Issues involved - 2 Current migraine medications should be reviewed –Simple and combined analgesics –Opiates –Triptans –Ergots –Preventive medications Review patient experience of efficacy and safety

Issues involved - 3 Co-morbidities and relevant medications should be reviewed –Risk factors for cardiovascular disease –Liver / kidney problems –Diabetes –Epilepsy –Psychiatric illness –Pregnancy / breast-feeding –Smoking status

Contraindications to medications: NSAIDs Drop-down menus Asthma / anti-inflammatory allergy Current or history of GI upset (e.g. ulcer, bleeding) Cardiovascular disease Liver disease Kidney disease Pregnancy Breast-feeding

Contraindications to medications: Analgesic-anti-emetic combinations Drop-down menus Migramax (not recommended for OTC as contains metoclopramide) Domperamol –Severe liver and kidney disease –Pregnancy –Lactation –Use of dopamine agonists

Contraindications to medications: Triptans Drop-down menus Existing cardiovascular disease or presence of risk factors Hypertension Liver and kidney disease Pregnancy Breast-feeding Use of SSRIs

Discussion Are pharmacists comfortable with these POM to P switches? –NSAIDs? (Yes) –Analgesic-anti-emetic combinations? (Domperamol – Yes; Migramax – No) –Triptans? (Yes) What needs to be done to implement these changes? (educational programme) Can we develop an algorithm for switching? (clear instructions required)

Migraine treatment algorithm Aspirin / NSAID Patient Lifestyle options Behavioural therapy Combination analgesic or Sumatriptan 50 mg Lifestyle options Behavioural therapy Preventive therapy Alternative preventive therapy Refer to GP If initial treatment unsuccessful Initial treatment Follow-up treatment If treatment unsuccessful

The role of the pharmacist in the practice headache team Act as a first point of contact for patients with headache Screen for diagnosis and medical need –Treat appropriate patients with available OTC medications –Refer appropriate patients to the GP Act as an extra advice and information resource after patients have consulted with the GP Take part in practice activities –Meetings –Locality-based training

Pharmacist Community nurse Optician Dentist Complementary practitioner Patient Primary care physician Practice nurse Physician with expertise in headache: GP; PCT; specialist Ancillary staff Primary care Specialist care Associate teamCore team Copyright MIPCA 2002, all rights reserved Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

Affiliation of MIPCA with the RPS Discussion between MIPCA and Christine Glover (CPPE)