Appendix
Pharmacist guidance notes are shown in italics.
Migraine Questionnaire – UK study
Pharmacist to complete
Please answer the following questions by ticking the appropriate answer
1. Is the customer aged between 18 and 65?
Yes
No
If the customer is aged between 50 and 65, go to Question 2. If not got to Question 3a.
You do not need to ask this question if you can guess the approximate age of the customer. IMIGRAN
Migraine Relief is only for people aged 18-65. If the customer is aged between 50 and 65, go to
Question 2. If not, go to Question 3a.
2. Did the symptoms of migraine occur for the first time over the age of
Yes
No
50?
People with migraine occurring for the first time over the age of 50 should see their doctor.
Migraine diagnosis
Yes No
3a. Has a doctor diagnosed migraine?
If the customer has had migraine diagnosed by their doctor, you may not need to answer
question 3b.
3b. In the last three months, has a headache interfered with their
activities on
at least one day?
When they have a headache, do they feel nauseous (sick)?
Yes
No
Yes
No
Yes No
When they have a headache, does light bother them?
Two out of three answers in Question 3b must be ‘YES’ to indicate a diagnosis of migraine.
However if a customer has been treating migraine successfully with a prescription or over-thecounter product, they may answer ‘no’ to these questions. You may need to ask about untreated
or unsuccessfully treated migraine to indicate diagnosis in this situation.
4. During their migraine, do they have any symptoms that mean they
Yes No
should
be referred to their GP?
The presence of the following symptoms might suggest a rare variant of migraine or an
alternative cause of headache - unilateral motor weakness, double vision, clumsiness or
uncoordinated movements, tinnitus (ringing in the ears), reduced level of consciousness, seizurelike movements (fits), a recent rash with a headache or a headache confined to the back of the
head.
5. What medication is the customer currently taking?
________________________________________________________________________
IMIGRAN Migraine Relief must not be used with MAOIs and other triptans (5-HT1 agonists).
IMIGRAN Migraine Relief should not be taken within 24 hours of ergotamine. Reviewing the
customer’s prescribed drugs, for example, antihypertensives, or whether they have previously
taken IMIGRAN, may highlight contraindicated medical conditions (see Question 9).
Yes No
Is the customer obese?
We do not include this extra risk factor for heart disease in the customer section of the
questionnaire because it may cause offence. It is acceptable to judge whether the customer is
obese without directly asking them.
Customer to complete
Please answer the following questions by ticking the appropriate answer. If you cannot answer any of
the questions, please leave it blank and ask the pharmacist or the pharmacy staff for help.
Section A. About your migraine
Not suitable for IMIGRAN Migraine Relief if they answer “NO” to one or more questions in Section A.
6. In between your migraine attacks, does the headache go away?
Yes
No
7. On average, do you have three or fewer migraine attacks each month?
Yes
No
8. Over the last three months, has the pattern of your migraine attacks
been generally similar? (Consider how long they last, how often you
get them and how severe they are.)
Yes
No
It is normal to have some differences between migraine attacks. You can discuss this with the
customer.
Section B. About you
Not suitable for IMIGRAN Migraine Relief if they answer “YES” to one or more items in Question 9.
9. Do you have, or have you had, any of these medical conditions?
Heart disease including heart attack, angina (chest pain following
physical activity), or heart failure?
Yes
No
Problems with your circulation?
Yes
No
High blood pressure? (You should get this checked each year)
Yes
No
Stroke or mini stroke (transient ischaemic attack, TIA)?
Yes
No
Liver or kidney disease?
Yes
No
Known allergy to Imigran (sumatriptan)?
Yes
No
Epilepsy or are you prone to having fits?
Women - are you pregnant, might you be pregnant or are you
breastfeeding?
Not suitable for IMIGRAN Migraine Relief if:
- they answer YES to three or more items in Question 10 or
- they answer YES to two items in Question 10 and are obese.
Yes
No
Yes
No
NA
10. If you are a woman, are you post-menopausal? (have your
natural periods stopped)
Yes
No
NA
If you are a man, are you aged over 40?
Yes
No
NA
Do you have high cholesterol?
Yes
No
Unsure
Did any parent, brother or sister develop heart disease (heart
Yes
No
Unsure
Do you regularly smoke more than 10 cigarettes per day?
Yes
No
Are you diabetic?
Yes
No
attack or angina) before the age of 60?
Obesity, the additional risk factor for heart disease is on the pharmacist section of the
questionnaire.
Unsure
Migraine Questionnaire – Australian study
Confirming migraine diagnosis – to be completed by the pharmacist
1. Has your doctor given you any medicines for migraine?
Yes
No
Ask for details. If the subject can give the name a migraine-specific treatment, this provides good evidence of a
previous doctor diagnosis of migraine. You may not need to complete Question 2 to help confirm a migraine
diagnosis. Treatments include 5HT1 agonists (Imigran®, Suvalan®, Naramig®, Zomig®); ergotamine
(Cafergot®, Dihydergot®); prophylactic therapy (Sandomigran®); methysergide (Deseril®) etc.
2. To help make a migraine diagnosis, please answer the following:
In the last three months, has a headache interfered with your activities
on at least one day?
When you have a headache, do you feel nauseated (sick)?
When you have a headache, does light bother you?
Yes
No
Yes
Yes
No
No
To help confirm a diagnosis of migraine, at least 2 out of 3 answers to this question must be ‘Yes’. However, if
the subject has been treating migraine successfully with prescription or OTC products, they may answer ‘No’ to
these questions, so you may need to frame the question in relation to untreated or unsuccessfully treated
migraine.
3. Did the symptoms of migraine occur for the first time over the age of
50?
Yes
No
If 'Yes', please check whether the subject has seen their doctor. If a doctor has not diagnosed migraine, a 'Yes'
response means that the subject is not suitable for treatment (but please continue with the Migraine
Questionnaire) and should see their doctor. If 'Yes' and a doctor has diagnosed migraine, please make a note of
this in the Comments section of the CRF and continue with the Questionnaire: the subject is potentially suitable
for treatment.
4. When you suffer from this type of headache, do you get any other symptoms apart from the
Yes
No
nausea/sickness or sensitivity to light or sound?
Other symptoms……………………………………………………………
Mark ‘Yes’ if the subject reports any atypical symptoms (see below).
If ‘Yes’ refer the subject to a doctor as they will not be suitable for OTC sumatriptan if any of the following
symptoms are reported – unilateral motor weakness, double vision, clumsiness or uncoordinated movements,
tinnitus (ringing in the ears), reduced level of consciousness, seizure like movements (fits), a recent rash with a
headache or headache confined to the back of the head.
Any recent worsening or major change in symptoms should be referred to a doctor.
Days per
month
5i. On average, how many days of headache do you have per month?
Subjects with headache occurring on 15 or more days per month should see their doctor.
Attacks
per month
5ii. On average, how many migraine attacks do you have each month?
The subject who has 4 or more attacks per month should be referred to their doctor.
It may be difficult to establish a pattern of migraine if the subject has only recently developed migraine
(< 6months or < 5 attacks).
5iii. In between your migraine attacks, does the migraine go away?
Yes
No
Migraine headache is episodic, so there should be recovery between attacks.
Any neurological symptoms (listed in Q4) should be referred to a doctor.
5iv. On average, how long does your migraine headache last if you don’t
take any medication, or if the medication doesn’t work?
Hours
Migraine headaches which last over 24 hours should be referred to a doctor
If a headache lasts less than 4 hours without treatment, the subject is not suitable to receive OTC sumatriptan.
Is the subject obese?
Yes
No
We do not include this extra risk factor for heart disease in the subject’s section of the questionnaire
because it may cause offence. It is acceptable to judge whether the subject is obese without directly
asking them.
Suitability Assessment - to be completed by the subject
6. What medicines are you currently taking? (Include prescription medicines from your doctor, including
the contraceptive pill, as well as over-the-counter (OTC) medicines, complementary medicines or
herbal remedies that you may have bought yourself.)
________________________________________________________________________________________
________________________________________________________________________________________
Ergotamine, ergotamine derivatives and other triptans (5HT1 agonists) should not be used for the same migraine
attack.
Reviewing the subject’s medicines (e.g. antihypertensives) and previous or current experience with sumatriptan
may highlight contraindicated medical conditions (Question 7).
Sumatriptan must not be used if MAOIs have been taken in the last 2 weeks.
Women using a combined oral contraceptive pill should consult their doctor if the onset of migraine is recent,
or if there is a worsening of migraine attacks.
7. Are you aged under 18 or over 65?
Do you have, or have you had, any of these medical conditions?
Heart disease including heart attack, angina or heart failure?
Liver or kidney disease?
Stroke or mini stroke (transient ischaemic attack, TIA)?
Epilepsy or are you prone to having fits?
Peripheral vascular disease (problems with your circulation causing
pain in your calves when walking)?
High blood pressure? (You should get this checked each year.)
Have you ever had an allergy or bad reaction to sumatriptan
(Imigran®, Suvalan®)?
Women - are you pregnant, might you be pregnant or are you
breastfeeding?
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
No
No
Unsure
Yes
No
Not
Applicable
Yes
No
Yes
No
Not
Applicable
Not
Applicable
Unsure
If any response to these questions is ‘Yes’ OTC sumatriptan may be contraindicated.
8. Women, are you post-menopausal? (Have your natural periods
stopped?)
Men, are you aged over 40?
Yes
No
Do you have high cholesterol?
Did any parent, brother or sister develop heart disease
(heart attack or angina) before the age of 60?
Yes
No
Yes
No
Do you regularly smoke more than 10 cigarettes per day?
Yes
No
Are you diabetic?
If 3 or more responses, including obesity, are ‘Yes’, OTC sumatriptan 50 mg is not suitable.
Significant risk factors for cardiovascular disease should be assessed by a doctor.
Obesity, the additional risk factor for heart disease, is on the pharmacist section of the
questionnaire.
Unsure
Migraine Questionnaire – German study1
1. About you…
Are you:
i. Under 18 years of age?
Yes
No
ii. Over 65 years of age?
Yes
No
iii. If you are female, are you pregnant, do you think you might be pregnant, or
are you breastfeeding?
Yes
No
Not
applicable
Subjects who answer ‘yes’ to any of these questions are not suitable for naratriptan.
2. About your migraine…
Yes
1. Has your Doctor ever told you that you suffer from migraine?
If the subject says ‘yes’, you may not need to complete Question 2 to help confirm a migraine diagnosis.
No
Yes
No
2. In the last three months, has a headache interfered with your activities on at least one
day?
Yes
No
When you have a headache, do you feel nauseous (sick)?
Yes
No
When you have a headache, does light bother you?
To help confirm a diagnosis of migraine 2 out of 3 answers to this question must be ‘Yes’. However, if a subject
has been treating migraine successfully with prescription or OTC products, they may answer ‘No’ to these
questions, so you may need to frame the question in relation to untreated or unsuccessfully treated migraine.
3i. On average, how many days of headache, including migraine, do you have
per month?
Subjects with headache occurring on 15 or more days per month should see their doctor.
Days per month
Attacks per month
3ii. On average, how many migraine attacks do you have each month?
A subject who has 4 or more attacks per month should be referred to their doctor. However, they can still be
given naratriptan for an acute attack, providing all other answers indicate suitability for naratriptan.
It may be difficult to establish a pattern of migraine if the subject has only recently developed migraine.
3iii. In between your migraine attacks, do all the symptoms of your migraine go away?
Migraine headache is episodic, so there should be recovery between attacks.
Any neurological symptoms (see Q4) should be referred to a doctor.2
Yes
No
Hours
3iv. On average, how long does your migraine headache last if you don’t take
any medicine, or if it doesn’t work?
If a headache lasts less than 4 hours without treatment, the subject is not suitable to receive naratriptan.
Migraine headaches which last over 24 hours should be referred to a doctor.
4. When you have a migraine headache, do you get any other symptoms apart from the
nausea/sickness or sensitivity to light or sound?
Other symptoms……………………………………………………………
Refer subject to a doctor as they will not be suitable for naratriptan if any of the following are reported:
unilateral motor weakness, double vision, clumsiness or uncoordinated movements, tinnitus (ringing in the ears),
reduced level of consciousness, seizure like movements (fits), a recent rash with a headache or headache confined
to the back of the head.
Yes
No
Do any of the subject’s symptoms require referral to a doctor?
Yes
No
5. Did the symptoms of migraine occur for the first time over the age of 50?
People with migraine occurring for the first time over the age of 50 should see their doctor.
If a doctor has subsequently confirmed a diagnosis of migraine please make a note of this in the Comments
section of the CRF and continue with the Questionnaire: the subject may still be suitable for naratriptan. If
symptoms occurred for the first time over the age of 50 and a doctor has not diagnosed migraine, the subject is
not suitable for naratriptan.
3. About your medical history…
6. What medicines are you currently taking (prescription medicines from your doctor, including
the contraceptive pill, as well as medicines or herbal remedies you may have bought yourself)?
_____________________________________________________________________________________
___________________________________________________________________________________
Ergotamine, derivatives and other triptans (5HT1 agonists) should not be used for the same migraine
attack.
Reviewing the medicines (e.g. antihypertensives) and previous or current experience with naratriptan
may highlight contraindicated medical conditions.
Women using a combined oral contraceptive pill should consult their doctor if the onset of migraine is
recent, or if there is a worsening of migraine attacks.
7. Has your doctor told you that you have or have had any of the following?
Heart disease including heart attack, angina (heart pain in the chest
brought on by exercise or exertion) or heart failure.
Stroke or mini stroke (transient ischaemic attack, TIA).
Peripheral vascular disease (for example, poor blood flow to the legs
with pain on walking).
Liver or kidney disease.
Hereditary galactose intolerance, lactose deficiency or glucose-galactose
malabsorption.
Do you have high blood pressure, or are you taking medication for high
blood pressure? (You should get this checked each year.)
Yes
Yes
No
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
Yes
No
Men, are you aged over 40?
Yes
No
Did any parent, brother or sister develop heart disease (heart attack or
angina) before the age of 60?
Has your doctor told you that you have diabetes?
Have you been told that you have high cholesterol?
Do you regularly smoke more than 10 cigarettes per day?
Yes
Yes
Yes
Yes
No
No
No
No
Is the subject obese?
Yes
No
Have you ever had an allergy or bad reaction to naratriptan?
If any response to these questions is ‘Yes’ naratriptan may be contraindicated.
8. Do any of the following risk factors apply to you?
Women, have you reached the menopause?
Unsure
Not
applicable
Not
applicable
Unsure
Unsure
Obesity is an important cardiovascular risk factor. A visual assessment to identify those who are clearly obese (BMI
> 30 kg/m2) is acceptable.
If a subject has three or more risk factors, naratriptan is not suitable. Significant risk factors for
cardiovascular disease should be assessed by a doctor.
________________________________________
1
The MQ was translated into German for the study.
During the pharmacist training sessions held prior to the start of the study, pharmacists were given
clear instructions to consider subjects with a migraine headache duration in excess of 24 hours as
potentially suitable for naratriptan. However, such cases were to be referred to a doctor.
2