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

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


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;57:492-507


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;17:298-309


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


B. Consider short-lasting chronic headaches

15 min - 3 hours may be cluster headache

Dowson AJ, Cady RC. Rapid Reference to Migraine 2002


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;13:277-83

Olesen J. BMJ 1995;310:479-80


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

Not medicationdependent

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

Yes No

Exclude sinister Headache (<1%)

Consider short-lasting Headaches (<1%)


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; www.neurology.org Dowson AJ et al. Curr Med Res Opin 2002;18:414-39

http://www.neurology.org/

Assessment of severity

Mild-to-moderate migraine Moderate-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; www.neurology.org



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



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



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



Tailored care for migraine

Migrainediagnosis

Severityassessment

Mild to moderate migraine Moderate to severe migraine

Initial therapy Initial therapy

Rescue Rescue

If unsuccessful

Migraine attack

Dowson AJ et al Int J Clin Pract 2003;57:492-507

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; www.neurology.org

http://www.aan.com/

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


http://www.aan.com/

Assess migraine severityImpactAttack frequency and durationPain severityNon-headache symptomsPatient history and preferences

IntermittentMild-to-moderate

IntermittentModerate to severe

Behavioural therapyAnalgesic-based therapies

Behavioural therapyAppropriate triptan

Second dose / alternative

formulation triptanSymptomatic

treatment

Initial treatment

Rescue Rescue

Behavioural therapyAnalgesic-based therapies

Behavioural therapyAppropriate triptan

Prophylaxis /Referral

Success

FailureFailure

Success Failure

Evaluation

Follow-up treatment

Rescue

Rescue

Lipscombe S et al. Headache Care 2004;1:147-57

Rescue and follow-up medications

Initial medication Rescue or follow-up medications

Analgesic-based medications Try a second dose

Triptan tablets*

Oral triptans* Try a second dose

Alternative triptan tablets

Nasal spray or sc triptan

Nasal spray triptan Try a second dose

sc sumatriptan

sc sumatriptan Try a second dose

Symptomatic treatment

* Conventional tablet or ODTLipscombe 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)


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


http://www.aan.com/

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


http://www.aan.com/

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 severityImpactAttack frequency and durationPain severityNon-headache symptomsPatient history and preferences

Intermittent attacks Frequent attacks

Acute treatments Prophylaxis

Initial treatment

Acute treatments Try second prophylactic drug Refer

Evaluation

Follow-up treatment

Treat for ≤ 6 monthsTaper /

withdraw

Suspect CDH

Suspect CDH

Suspect CDH

Success Failure

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


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


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


Pharmacist

Community nurse

Optician

Dentist

Complementary practitioner

Patient

Primary care physician

Practice nurse

Physician with expertise in headache:

GP; PCT; specialist

Ancillarystaff

Primary care Specialist care

Associate team Core team

Copyright MIPCA 2002, all rights reserved


New MIPCA algorithm

Initial consultation and treatment

Detailed history, patient education/commitmentDiagnostic screening and differential diagnosisAssess illness severity

Attack frequency and durationPain severityImpact (MIDAS or HIT questionnaires)Non-headache symptomsPatient history and preferences

Intermittentmild-to-moderate migraine

(+/- aura)

Intermittentmoderate-to severe migraine

(+/- aura)

Paracetamol/Aspirin/NSAID (large dose)Aspirin/paracetamol plus anti-emetic

Oral triptan

2nd dose/alternative oral triptan/Nasal spray/subcutaneous

triptan

Initial

consultation

Initial treatment

Rescue

Rescue

Behavioural/complementary therapies



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 triptan2nd dose/Alternative oral triptan

Nasal spray/sc triptan/Symptomatic

Rescue

If unsuccessful

Consider prophylaxis +acute treatment for

breakthrough migraineattacks

Frequent headache(i.e. 4 attacks per month)

Consider referralChronic daily

headache (CDH)?

Migraine

If unsuccessful

If unsuccessful

Initial treatmentCopyright MIPCA 2002, all rights reserved

If management unsuccessful


‘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)



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



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)



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)



Management

5. Follow-up patients, preferably with migraine diaries

(Invite the patient to return for further management and apply a proactive policy)



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)



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)



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)



Treatments

9. Monitor prophylactic therapy regularly



Treatments

10.Ensure that the patient is comfortable with the treatment recommended and that it is practical for their lifestyle and headache presentation



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)


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


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)


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)


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 headacheOver 2 hours = migraine / CDHConstant headaches = CDH


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 MOH2 or more = MOH


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

ETTH MigraineChronic

Headache*Possiblesinister

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 200-600 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 11 2004; 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 18-65 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 optionsBehavioural therapy

Combination analgesic or Sumatriptan 50 mg

Lifestyle optionsBehavioural

therapy

Preventive therapy

Alternativepreventive

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

Ancillarystaff

Primary care Specialist care

Associate team Core team



Affiliation of MIPCA with the RPS

• Discussion between MIPCA and Christine Glover (CPPE)

Documents

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