1. Headache Care for Practising Clinicians Establishing principles for migraine management in primary care Meeting in Vienna at the EFNS 26 October 2002

2. Introduction Recent academic meetings have contained relatively little material on the management of migraine in primary care However, new guidelines for the management of migraine have recently been developed in the USA and the UK –Headache Consortium –Primary Care Network –MIPCA

3. MIGRAINE IN PRIMARY CARE ADVISORS MIPCA is an independent charity working through research and education to set standards for the care of headache sufferers –Dedicated to improve headache management in primary care MIPCA contains physicians, nurses, pharmacists, other healthcare professionals and representatives from patient groups

4. Headache Care for the Practising Clinician We propose a new forum to improve the standard of headache management in primary care –‘Headache Care for the Practising Clinician’ Annual meeting (Copenhagen style) 2 nd meeting in October 2003 in Monte Carlo Great interest from the pharmaceutical industry Arrangements set up in 1 st Annual Meeting in 2002 –Migraine Trust for US –EFNS for whole world

5. 1 st Annual Meeting: Programme 8.00 am: Breakfast and Introduction 8.30 am: Diagnosis of headache in primary care 9.30 am: Coffee break 9.45 am: Principles of managing migraine in primary care 10.45 am: Agreeing principles of migraine management for international use

6. 1 st Annual Meeting: Programme 11.30 am: Break 11.50 am: Agreeing the faculty and programme for the 2 nd HCPC meeting in October 2003 in Monte Carlo 1.00 pm: Close and Lunch

7. 1 st Annual Meeting: Objectives Develop agreed principles of migraine management for use in primary care –Review the latest initiatives that have developed migraine guidelines –Agree principles of care that can be recommended for international use Agree the programme and faculty for the 2003 meeting

8. 1 st Annual Meeting: Outcomes Produce specific outcomes for wide dissemination –Article to be published in a peer-reviewed journal –‘Popular’ newsletter designed for primary care physicians –Slide set for educational use –Further outcomes to be defined

9. 1 st Annual Meeting: Progress to date Meeting held with US PCPs at the Migraine Trust in London –Agreed that PCPs should the main focus of care for headache management –Need for an independent organisation driven by practising clinicians –Multidisciplinary approach recommended –A separate committee will be set up to move forward the HCPC initiative in the USA

10. Developing agreed principles of migraine management for use in primary care

11. Recent initiatives for migraine management in primary care Starting points for new initiatives –US Headache Consortium 1 –US Primary Care Network 2 –UK MIPCA Guidelines 3 –German guidelines 4 –Canadian guidelines 5 1 Headache Consortium. Neurology 2000; www.aan.com. 2 Bedell AW et al. Primary Care Network 2000. 3 Dowson AJ et al. MIPCA 2000. 4 Diener HC et al. Nervenheilkunde 1997;16:500-10. 5 Pryse-Phillips WEM et al. Can Med Assoc J 1997;156:1273-87.www.aan.com

12. US Headache Consortium guidelines Attack frequency Attack severity Degree of disability Non-headache symptoms Patient participation – preference – prior response – co-existent conditions IHS criteria Migraine diagnosis Disability assessment Patient communication and education Individualised management Stratified care Assessments of migraine impact Lipton RB, Silberstein SD. Neurology 2001;56 (Suppl 1):35-42.

13. US Primary Care Network guidelines Impact-based recognition of migraine  How do headaches interfere with your life?  How frequently do you experience headaches of any type?  Has there been any change in your headache pattern over the last 6 months?  How often and how effectively do you use medication to treat headaches Acute treatment strategy  Provide patient education and instruction  Tailor intervention to the patient’s needs and select the best therapy for each patient  Treat as early as possible in the attack  Abort migraine symptoms and disability within 2−4 hours of initiating therapy Preventative treatment strategy  Address patient expectations and compliance by providing patient education and instruction  Develop a formal management plan  Use headache diaries  Reduce attack frequency, duration, severity and disability  Prevent the development of CDH Choice of acute treatments  Mild headache: triptans, isometheptene, NSAIDs, OTC combination analgesics  Moderate to severe headaches: triptans or NSAIDS or OTC combination analgesics if previously successful Choice of preventative medications  Beta-adrenergic blocking agents  Tricyclic antidepressants  Anticonvulsants ≤2 headaches per week>2 headaches per week Bedell AW et al. Primary Care Network 2000.

14. MIPCA initiative: Establishing new management guidelines for migraine in UK primary care Update of the existing MIPCA guidelines –Identification and screening of patients in need of care –Development of new diagnostic tools and algorithms –Best management practice Utilising evidence-based medicine wherever possible Incorporating latest data from UK and US guidelines

15. What is required Best practice from existing guidelines Detailed history taking, patient education and engagement with care Diagnostic screening and confirmatory differential diagnosis Management individualised for each patient Prescribing only treatments that have objective evidence of favourable efficacy and tolerability Prospective follow-up procedures to monitor the success of treatment Specific consultations for headache and a team approach to management Headache Consortium. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000. Dowson AJ et al. MIPCA 2000.

16. 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 engagement Follow-up Assess outcome of therapy Management individualised for each patient Overall diagram for migraine management

17. New MIPCA algorithm Initial consultation and treatment

18.  Detailed history, patient education and buy-in  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) Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic 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.

19. New MIPCA algorithm Follow-up consultation and treatment

20. Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic Oral triptan Initial treatment Follow-up treatment Oral triptan Alternative oral triptan Nasal spray/subcutaneous triptan Rescue If initial treatment 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.

21. Outputs from the UK project Peer-reviewed article published in Curr Med Res Opin MIPCA newsletter (‘popular GP’ version) Summary and article in Guidelines Slide set CD Rom Further meetings and educational items planned for GPs, specialists, nurses, pharmacists and patients Dowson AJ et al. Curr Med Res Opin 2002;18:414-39.

22. Developing agreed principles of migraine management for international use in primary care Screening and diagnosis for headache

23. Processes First consultation –Screening –Patient education and engagement with care –Diagnosis –Assessment of illness severity –Implementation of initial treatment plan Follow-up consultations –Monitor success of therapy and modify treatment if necessary

24. Screening procedures: history taking, patient education and engagement Taking a careful history is essential –Use of a headache history questionnaire is recommended Patient education –Advice, leaflets, websites and patient organisations Patient engagement with care –Patients to take charge of their own management –Effective communication between patient and physician Headache Consortium. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000.

25. Migraine diagnosis: IHS criteria Five or more lifetime headache attacks lasting 4-72 hours each and symptom-free between attacks Two or more of the following headache features: –Moderate-severe pain –Unilateral –Throbbing/pulsating –Exacerbated by routine activities One or more of the following non-headache features: –Aura –Nausea –Photophobia/phonophobia Exclusion of secondary headaches Headache Classification Committee of the IHS. Cephalalgia 1988;7 (Suppl 7):19-28

26. Screening / diagnosis of headache Proposal: the IHS diagnostic criteria are too limited in scope and complex for everyday use in primary care MIPCA has developed a simple but comprehensive scheme for the differential diagnosis of headache subtypes Diagnosis can then be confirmed with additional questions, if required –Possibly based on the IHS criteria –Headache diaries

27. 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, hypertension –Neurological change/deficit does not disappear when the patient is pain-free between attacks –Develop algorithm for sinister headaches Dowson AJ, Cady RC. Rapid Reference to Migraine 2002.

28. Patient presenting with headache Exclude sinister Headache (<1%)

29. Four-item questionnaire 1.What is the impact of the headache on the sufferer’s daily life? (screens for migraine/chronic headaches and ATTH)

30. 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%) Exclude sinister Headache (<1%)

31. The diagnostic importance of headache impact The vast majority of episodic, impactful headaches reported by patients are caused by migraine 1 The migraine process may present as true migraine, migrainous headache and TTH 2 TTH is usually not impactful and few patients consult a physician for it 3 1 Dowson A et al. Cephalalgia 2002;22:590-1. 2 Lipton RB et al. Headache 2000;40:783-91. 3 Lipton RB et al. Neurology 2002; 58 (9 Suppl 6):27-31.

32. Assessing headache impact Headache diaries Two impact questionnaires have also been developed –Migraine Disability Assessment (MIDAS) Questionnaire –Headache Impact Test (HIT) –Both questionnaires are Reliable and valid measures of impact Have wide applications in headache management HIT may be a particularly sensitive diagnostic tool Dowson A. Curr Med Res Opin 2001;17:298-309.

34. 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 1988;7 (Suppl 7):1-92

35. 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%) Migraine (10-12%) Exclude sinister Headache (<1%)

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

37. 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%) Migraine (10-12%) Exclude sinister Headache (<1%) Consider short-lasting Headaches (<1%)

38. Four-item questionnaire 3.For patients with chronic daily headache, on how many days per week does the patient take analgesic medication? (screens for medication overuse headaches)  2 = medication overuse <2 = no medication overuse Silberstein SD, Lipton RB. Curr Opin Neurol 2000;13:277-83 Olesen J. BMJ 1995;310:479-80.

39. 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 analgesic medications? <2 22 No medication overuse Medication overuse Migraine (10-12%) Exclude sinister Headache (<1%) Consider short-lasting Headaches (<1%)

40. 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 1988;7 (Suppl 7):19-28

41. Migraine with aura diagnosis: IHS criteria At least three of the following four characteristics: –One or more fully reversible aura symptoms* –One or more aura symptoms develop over >4 min, or two or more symptoms occur in succession –No single aura symptom lasts >60 min –The migraine headache occurs <60 min after the end of the aura symptoms Exclusion of secondary headaches *e.g. visual disturbances, speech disturbances and sensations affecting other areas of the body Headache Classification Committee of the IHS. Cephalalgia 1988;7 (Suppl 7):19-28

42. 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 analgesic medications? <2 22 No medication overuse Medication overuse 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%)

43. Consulting patients with episodic headaches Migraine: 94% ETTH: 2.9% Sinister: <1% Short-lasting headaches: <1% Dowson AJ et al. Cephalalgia 2002;22:591.

44. Headache diagnosis: Discussion What is required: –New headache diaries –Simple questionnaire that confirms diagnostic screen –Algorithm for the diagnosis of sinister headaches

45. Developing agreed principles of migraine care for international use in primary care Management of migraine

46. Management individualised for each patient Assess illness severity Impact on daily living –MIDAS/HIT questionnaires Attack frequency and duration Pain severity Non-headache symptoms Patient factors –History, preference and other illnesses Matchar DB et al. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000.

47. Assessment of severity Intermittent, lower impact migraine Intermittent, higher impact migraine Impact lower, without significant time loss, e.g.: MIDAS Grade I or II HIT Grade 1 or 2 Impact higher, with significant time loss, e.g.: MIDAS Grade III or IV HIT Grade 3 or 4 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 Matchar DB et al. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000. Lipton RB et al. JAMA 2000;284:2599-605.

48. Provision of individualised treatment plan 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 Headache Consortium. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000.

49. Individualising care – behavioural and physical therapy Duke recommended therapies Behavioural: –Biofeedback and relaxation –Stress reduction –Avoidance of triggers –Food intolerances under investigation by MIPCA Physical –Cervical manipulation –Massage –Exercise Campbell JK et al. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000.

50. Individualising care – acute medications Goals: to rapidly relieve the headache and other symptoms, and permit the return to normal activities within 2 hours 1,2 Acute medications should be provided for all patients 2 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 3 1 Matchar DB et al. Neurology 2000; www.aan.com.www.aan.com 2 Dowson AJ et al. MIPCA 2000. 3 Dowson AJ. Migraine and Other Headaches: Your Questions Answered. 2003; in press.

51. Individualised care for migraine Migraine diagnosis Severity assessment Mild to moderate migraineModerate to severe migraine Initial therapy Rescue If unsuccessful Migraine attack Dowson AJ. Migraine and Other Headaches: Your Questions Answered. 2003; in press Stratified care Staged care

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

53. Acute medications: Duke recommended treatments 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 –Nasal spray or subcutaneous triptans –Symptomatic treatment Matchar DB et al. Neurology 2000; www.aan.com.www.aan.com

54. 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 incapacitating attacks may benefit from nasal spray or subcutaneous formulations Subcutaneous sumatriptan is an effective rescue medication Switching between alternative triptans is allowed Dowson AJ, Cady RC. Rapid Reference to Migraine 2002.

55. 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 Ramadan NM et al. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000. Silberstein SD, Goadsby PJ. Cephalalgia 2002;22:491-512.

56. Caveats on prophylactic medications Consider comorbidities before prescribing prophylaxis Patients with medication overuse headache should have acute medications withdrawn before initiating prophylaxis Acute medications should also be provided for breakthrough attacks Ramadan NM et al. Neurology 2000; www.aan.com.www.aan.com Bedell AW et al. Primary Care Network 2000. Dowson AJ et al. MIPCA 2000. Silberstein SD, Goadsby PJ. Cephalalgia 2002;22:491-512.

57. Prophylactic medications: Duke recommended treatments First-line medications: –Beta-blockers –Valproate –Amitriptyline Second-line medications –Serotonin antagonists –Calcium channel antagonists –Other anticonvulsants –Riboflavin –NSAIDs –SSRIs Ramadan NM et al. Neurology 2000; www.aan.com.www.aan.com Silberstein SD, Goadsby PJ. Cephalalgia 2002;22:491-512.

58. Individualising care – complementary therapies Effective therapies (Duke database) Feverfew Magnesium Vitamin B2 Acupuncture Low-dose aspirin? However: use only accredited complementary practitioners Dowson AJ, Cady RC. Rapid Reference to Migraine 2002.

59. 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, Cady RC. Rapid Reference to Migraine 2002.

60. 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 (up to 3 months) –If effective, treatment can continue for 6 months, after which it may be tapered off –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 –Assess quantity of medication used before referral Dowson AJ, Cady RC. Rapid Reference to Migraine 2002.

61. Implementation of guidelines Primary care headache team –PCP, practice nurse, ancillary staff and sometimes pharmacist (core team) Nurse practitioner/internist (USA) –Pharmacist –Community nurses –Optician –Dentist –Complementary practitioners –Specialist physician (additional resource) –And... The patient Associate team members Dowson AJ et al. Curr Med Res Opin 2002;18:414-39.

62. Pharmacist Community nurse Optician Dentist Complementary practitioner Patient Primary care physician Practice nurse Physician with expertise in headache: PCP; 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.

63. New management algorithm Initial consultation and treatment

64.  Detailed history, patient education and engagement  Diagnostic screening and differential diagnosis  Assess illness severity  Impact (MIDAS or HIT questionnaires)  Attack frequency and duration  Pain severity  Non-headache symptoms  Patient history and preferences Intermittent, lower impact migraine (+/- aura) Intermittent, higher impact Migraine (+/- aura) Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic Analgesic-isometheptene Appropriate triptan Increased dose / alternative formulation triptan Symptomatic treatment Initial consultation Initial treatment Rescue Behavioural/complementary therapies

65. New management algorithm Follow-up consultation and treatment

66. Aspirin/NSAID (large dose) Aspirin/paracetamol plus anti-emetic Analgesic-isometheptene Appropriate triptan Initial treatment Follow-up treatment Appropriate triptan Increased dose / alternative formulation triptan Symptomatic treatment Rescue If initial treatment 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 If management unsuccessful

67. Migraine management: Discussion Provide guidelines for the use of analgesics Evidence-based review of acute and prophylactic medications Consider concurrent comorbidities in the choice of prophylaxis

68. Principles of migraine management in primary care

69. Principles of headache management Initial principles created by MIPCA in the UK –‘10 Commandments’ Principles modified by 1 st HCPC Meeting in London –1 st step to ‘internationalise’ principles Key objective of Vienna meeting –To agree on recommended international principles that can be customised for use in separate countries Dowson AJ et al. Curr Med Res Opin 2002;18:414-39.

70. Agreed principles of migraine management for international use

71. Screening/diagnosis 1.Almost all headaches are benign/primary and can be managed by all practising clinicians. (The most common presenting headache is migraine. However, monitor for sinister headaches and refer if necessary.)

72. 2.Use questions / a questionnaire assessing impact on daily living for diagnostic screening and to aid management decisions. (Any stable pattern of episodic, high impact headaches should be given a default diagnosis of migraine. PCPs, nurses and pharmacists can all apply the questionnaire.) Screening/diagnosis

73. Management 3.Share migraine management between the clinician and patient. (The patient taking control of their management and the clinician providing education and guidance.)

74. Management 4.Provide individualised care for migraine and encourage patients to treat themselves. (Migraine attacks are highly variable in frequency, duration, symptomatology and impact.)

75. Management 5.Follow-up patients, preferably with migraine diaries. (Invite the patient to return for further management and apply a proactive policy.)

76. Management 6.Assess the success of therapy using specific outcome measures and monitor the use of acute and prophylactic medications regularly.

77. Management 7.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.)

78. Treatments 8.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 overuse of all drugs to avoid medication overuse headache.)

79. Treatments 9.Provide rescue medication / symptomatic treatment if the initial therapy fails. (Narcotics may be appropriate in certain circumstances in compassionate use.)

80. Treatments 10.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.)

81. Treatments 11.Consider concurrent comorbidities in the choice of appropriate prophylactic medications.

82. Treatments 12.Work with the patient to achieve comfort with the treatment recommended and that it is practical for their lifestyle and headache presentation.

83. Outputs from the 2002 meeting Principles for managing migraine in primary care Peer-reviewed article published in learned journal Newsletter (‘popular PCP’ version) Slide set Further educational items to be defined