PHARMACY SUPPORT STAFFTRAINING GUIDE

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Quality • Consistency • Excellence

www.bristol-labs.co.uk

PHARMACY TRAINING GUIDE

Prescribing information and references can be found on the back cover.

Complete the questions to include in your self-development portfolio.

The little guide to a big problem

Developed and produced by Bristol Laboratories Ltd

MIGRAITAN® Sumatriptan 50mg

Migraine – more than just a bad headache

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Quality Seal 2015

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QuestionsTo receive your certificate of training, please photocopy this section and post the answers to the following questions along with the following information to: Bristol Laboratories Ltd, Bristol House, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG

Tick all that may apply:

Pain right across the whole of the head

One-sided pain in the head

Nausea

Black outs

Back pain

Visual disturbances

Aching limbs

Sudden onset

Gets worse with movement

1.

Flashing lights

Medication

Sunlight

Stress

Drinking too much alcohol

Foodstuffs

Smells

Exercise

Missing a meal

Hormonal changes

Flashing lights

Medication

Sunlight

Stress

Drinking too much alcohol

Foodstuffs

Smells

Exercise

Missing a meal

Hormonal changes

2.

3.

• Name

• Pharmacy name and address

• Job title

• Email address

• Answers to the questions

• Written confirmation that you have completed the training

Tick all that may apply:

Refer to the pharmacist

Refer to the WWHAM* protocol

Check the patient’s/customer’s circumstances have not changed

Check sumatriptan is a suitable choice of treatment

5.

Tick all that may apply:

Suggest he/she tries immediate relief using a fast acting painkiller

Refer the patient/customer to the pharmacist

Refer to the WWHAM* protocol

Recommend sumatriptan (Provided patients do not have any contraindications)

Tick those that apply:

Consider recommending sumatriptan

Refer to the pharmacist

Refer to the WWHAM* protocol

Ask the customer/patient what he/she wants

4.

6.

Tick any that might trigger any attack:

Tick all that may apply:

What are the characteristics of a migraine?

What might it be useful for patients to record in a diary of their migraine episodes?

If a patient/customer complains of migraine but has not been diagnosed, what should you do/recommend?

If a patient diagnosed with migraine asks for sumatriptan by name what should you do/recommend?

If you’re not certain about what to recommend, what should you do?

As well as environmental factors, what are the other possible triggers of a migraine attack?

*Who is the patient? What is the problem? How long has it been a problem? Action that has been taken to date. What other Medicines are taken?

INTRODUCTION

Migraine is a recurring, episodic and often lifelong disorder with headache and other symptoms and debilitating consequences (3).

It affects people during their productive years and, as a complex disorder, it is much more than just a ‘bad headache’. The World Health Organization (WHO)recognises migraines, “are of public health importance as they are responsible for high population levels of disability and ill-health” (15).

WHO acknowledges that there are various barriers to the effective care of migraine sufferers including: a lack of knowledge among healthcare providers and poor awareness among the general public (15).

As a common, debilitating, but frequently misunderstood disorder, helping people already diagnosed with migraine to relieve their symptoms is likely to be a valued pharmacy service. It is one of the most common reasons why people see their GP or a specialist neurologist (1).

What is a migraine?The signs of migraine may include: a one-sided or both sided throbbing or pulsating pain in the head made worse with activity (the word migraine is derived from the Greek word hemikrania meaning ‘half of the head’); a feeling of nausea or actually being sick; and/or light and/or

sound and/or smell sensitivity or aura (see below). People don’t necessarily need to have all these symptoms, just some of them, to point towards a migraine.

The International Headache Society has devised a diagnostic grid that allows doctors to complete a ‘tick box’ exercise (2).

Types of migraine

The most common type is migraine without aura, also known as common migraine. This is when the migraine occurs without any preceding visual or sensory symptoms. Another slightly less common type is migraine with aura (or classic migraine). Other common types of migraine include: menstrual migraine (women), abdominal migraine (mainly in children) and ocular/retinal/ophthalmic migraine. There are other types of migraine but these are very unusual.

Who’s at risk?Migraine affects both sexes and all ages, although the first attacks usually happen before people reach the age of 30 – in fact, half of the affected

population is below the age of 20. People most at risk are those with a family history of migraine..

PrevalenceMigraine is ranked as one of the three most common disorders and the seventh highest specific cause of disability worldwide (14). In the UK alone, there are an estimated 190,000 migraine attacks every day (11).

Characterised by attacks that occur anywhere between once a year and once a week, migraine occurs in 15% of the UK adult population, and is three times more likely to affect women than men (1).

TRAINING OBJECTIVES

This guide is suitable for use by medicines counter

assistants and pharmacy professionals as part of

their ongoing learning. This guide has been produced

in collaboration with a leading headache specialist

Dr. Susan Lipscombe. Using this guide you will learn

the following:

• Understand migraine and the different types of migraine

• Be aware of the prevalence and the impact

of migraine

• Be familiar with the migraine causes and triggers

• Understand managing and preventing migraine

• Be able to recommend Sumatriptan

This guide aims to consolidate staff knowledge

and help them when talking about headache disorders

with customers.

PHARMACY TRAINING GUIDE

Causes and triggers The exact cause of migraine is unknown. However, it is believed to be the result of abnormal brain activity; this affects some people more than others on account of a genetic predisposition and may be ‘triggered’ by a range of environmental, emotional, physical and dietary factors (8).

Migraineurs (people who suffer with migraine) may often have specific triggers, or a combination of triggers, which can be quite variable, involving changes in the internal or external environment. Internal triggers include stress, dehydration, a missed meal, individual foodstuffs, or hormonal changes around menstruation; external triggers can involve environmental factors; for example, a thundery day, bright winter sun, loud noise, or strong smells – particularly from petrochemicals.

Triggers can be difficult to identify, but it helps if people keep a diary of when the attack occurs. This can help doctors discover if there is any emerging pattern.

Managing migraine

A migraine is more likely to affect people during the day than at night – half of all sufferers either wake with a migraine or have an attack within one hour of waking.

Some are woken early by a migraine which is associated with a range of symptoms including: a headache, heightened sensitivity to light and noise, nausea, vomiting, dizziness and eyesight changes (13). These associated symptoms help distinguish it from the more common tension-type headache.

Migraine is known as a phasic condition, (ie having distinct stages that help distinguish it from other headaches) it is associated with vague prodrome symptoms (such as lethargy) and sensory aura for some and headache with associated symptoms and hangover like symptoms- postdrome.

PreventionMigraine can be managed, partly at least, by preventing the next attack. Preventative drugs for migraine require a daily dose either once a day or even several times a day; the idea is to increase the threshold for the headache and so decrease ‘breakthrough’ attacks. Preventative drugs may be particularly helpful for those patients who suffer from regular migraines, (ie three to four attacks per month or more) and when no consistent response to rescue therapies is noted.

Some over-the-counter (OTC) supplements such as vitamin B2, magnesium and co-enzyme Q10 may be useful. Other drugs that may be suitable are prescription only. However, there will still be a need for treatment, (ie a ‘rescue’ painkiller) following any emergent attacks. This will need to be something that is known to be effective and that works quickly. However, over-use of such rescue (painkilling) medication may mean the effectiveness of the drug is reduced over time and more headaches may follow (medication over-use headaches).

The diary might record:

The time the migraine started and ended

The site of the pain

The nature of the pain

Other symptoms

Details of any other medication taken

before the headache started

Food eaten beforehand

Recent exercise

Weather conditions and location

The role of genes Most people are born with a predisposition to have migraine attacks – it does run in families: if someone has a parent with migraine, his/her risk of migraine is doubled and it’s doubled again if both parents suffer.

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Self-helpWhen the triggers are known, an obvious migraine management strategy is to try to avoid them, although it may not be possible for patients to control some triggers. These triggers will vary from person to person.

Signs and symptoms

Migraine is a ‘phasic’ condition, (ie it is associated with different phases and symptoms).

About 40% of sufferers have vague lead-in or warning symptoms such as physical and psychological symptoms

including: tiredness, cravings, increased urination, thirst, an altered perception of heat and cold, muscle stiffness, and constipation/diarrhoea. At this time they may sense a migraine is about to happen, although this feeling could persist for several days until the headache phase begins. Some patients may mistakenly perceive these symptoms as triggers, or not initially regard them as symptoms of migraine (12). This phase is known as the ‘prodrome’ and the symptoms are known as prodromal symptoms.

In the hour before an attack about 10% of sufferers have auras every time which also warn a migraine is about to occur. These sensory and visual disturbances last between five minutes and one hour. Other sufferers will notice these auras only occasionally.

Then comes the core headache phase, where there is another group of symptoms. After the headache is gone (it normally lasts between four and 72 hours), there’s another phase where most people feel washed out or hung-over. This usually lasts until people have slept, but sometimes this feeling also persists for several days.

A one-day migraine (with a day of headache) could last four or five days by having impactful prodrome and

postdrome. This long footprint has the ability to impact on a patient’s wellbeing and quality of life.

Impact of migraineOne of the clear differentiations between a migraine and a tension-type headache is the amount of associated disability associated with it. Migraine, for example, is estimated to cost the UK around £2.25 billion per annum (7).

As well as a major cause of absence from work, migraine also impacts on schooling and education: an estimated 25 million days are lost every year (11). In a combined study of nearly 400 migraineurs in the UK and US, 85% percent of patients reported their headache reduced their ability to perform household chores and 36% said it affected their parenting abilities (4).

What are the treatment options?Migraine treatments divide into three options:

1 Avoidance of triggers: this can be a good starting point but is likely to mean that patients need to pay particular attention to a ‘regular’ lifestyle in terms of what they eat, how much they exercise, and how long they sleep. Good hydration can also be helpful. Not all triggers will be controllable by a sufferer.

2 Prevention: this requires patients to take medication every day in order to try to avoid the next attack.

3 Rescue (self) medications: used when an attack occurs, and always under the control of the patient.

Rescue drugs include over-the-counter analgesic type drugs: paracetamol, aspirin, and ibuprofen. In about half of patients these can be enough to control a migraine. They tend to be most effective if available early in the attack (9).

For most patients the aspirin/ibuprofen family does better than paracetamol (16).

However, if these products are found to become less effective over time, then this may merit starting the individual on a more specific treatment such as a triptan. Sumatriptan is the most commonly used drug in that family of medication.

A number of complementary therapies are also claimed to have also helped some sufferers. These include:

• Acupuncture • Chiropractice • Osteopathy

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What is sumatriptan?Sumatriptan is the active ingredient in Migraitan® and is in a class of medications called selective serotonin receptor agonists (or 5HT1-receptor agonists), also known as triptans. Triptans work by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Triptans cannot prevent migraine attacks.

Who is it for?Sumatriptan is appropriate for an established patient diagnosed with migraine and may be recommended to sufferers if painkillers are not helping to relieve their migraine (9).

If your customer says their headache is their first or worst headache, it may not be a migraine. In that situation a diagnosis from a GP is the right way forward.

• People with uncontrolled high blood pressure or severe liver problems

• People with certain types of migraines, (eg hemiplegic, basilar, ophthalmoplegic)

• People who have used certain other migraine medicines within the past 24 hours, (eg an ergot derivative, [eg dihydroergotamine], another serotonin 5-HT1 receptor agonist, [eg eletriptan, rizatriptan])

Please also refer to the prescribing information on the back cover.

When should I offer sumatriptan?Remember if the patient has an established pattern of migraine a pharmacist can make the diagnosis. Always discuss and check with your pharmacists.

When recommending Migraitan®, it is important to ask the consumer relevant questions to identify whether a person is suitable for sumatriptan.

The Migraitan® questionnaire will give medicine counter assistants and pharmacists the confidence to recommend Migraitan®.

If your customer has a pattern of past headaches and has already been diagnosed with migraine or prescribed sumatriptan then the right course of action is to take the customer through the Migraitan® questionnaire which can be used by medicine counter assistants and pharmacy professionals, and the WWHAM protocol (both included with this training guide). In this way staff can be sure the customer still meets the criteria for ongoing use of sumatriptan as part of their migraine management.

If your customer complains of a sudden onset headache, (ie one that is almost immediately painful) you should suggest they seek some urgent care through the pharmacist in the first instance. The pharmacist will direct the customer to their GP, NHS Direct or even Accident & Emergency in some situations.

Who shouldn’t take sumatripan?• Children (unless agreed by a doctor); people aged over 65,

pregnant or breastfeeding women (refer to a doctor).

• People allergic to any ingredient in sumatriptan

• People with a history of ischaemic heart disease, (eg angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease, (eg stroke, transient ischaemic attack), or other blood vessel disease, (eg Raynaud syndrome, ischaemic bowel disease)

ACKNOWLEDGEMENTS This guide has been developed and produced by Bristol Laboratories, manufacturers of Migraitan®. Bristol Laboratories gratefully acknowledges the specialist contribution of Dr. Susan Lipscombe to this guide. Dr. Susan Lipscombe MB ChB MRCP, Headache Specialist and GP, Royal Sussex County Hospital, Brighton.

Prescribing information: Product Name: Migraitan® 50mg Film–coated tablets. Composition: Sumatriptan succinate 50mg. See SmPC for full list of excipients. Indication: Acute relief of migraine attacks, with or without aura. Posology and method of administration: Not to be taken prophylactically. Recommended as a monotherapy, not to be given with ergotamine or ergotamine derivatives. Adults (18 to 65 years): Single 50mg tablet swallowed with water. Some patients may require 100mg. If no response to first tablet, no further tablet to be taken. If response, and symptoms recur, a second tablet may be taken in next 24 hours but at least 2 hours after first tablet. No more than 300mg to be taken in each 24 hour period. Elderly (over 65 years): Not recommended. Children: (less than 10 years): No clinical data, (10-17 years): Not recommended Mild to moderate Hepatic impairment: 25-50mg; Renal impairment: Use with caution. Contraindications: Those with:- previous myocardial infarction, ischaemic heart disease, coronary vasospasm, vascular disease, signs consistent with ischaemic heart disease, moderate and severe hypertension, mild uncontrolled hypertension, history of stroke, transient ischaemic attack, severe hepatic impairment, concomitant use with:- ergotamine, ergotamine derivatives, 5HT-1 receptor agonists, reversible or irreversible MAOIs. Patients with a known hypersensitivity to sulphonamides. Those with a known hypersensitivity to sumatriptan or any of the tablet ingredients. Special warnings and precautions for use: Only to be used with a clear diagnosis of migraine. Not for use with hemiplegic, basilar or ophthalmologic migraine. Before treating headaches, care should be taken to exclude other potentially serious neurological conditions. Sumatriptan can be associated with transient symptoms of chest pain and tightness involving the throat. Not to be used in patients in whom unrecognized cardiac disease is likely without prior medical assessment. Special consideration should be given to post-menopausal women and males aged over 40 years. Rare reports reported of serotonin syndrome, asthenia, hyper-reflexia and incoordination following concomitant use of SSRIs and sumatriptan. Treat with caution in patients with hepatic and renal impairment, history of seizures, controlled hypertension. Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine. The recommended dose should not be exceeded. Interactions with other medicinal products: Potential interaction with MAOIs, ergotamine or ergotamine derivatives, other triptan/5HT-1 receptor agonists. Contraindicated for concomitant administration with MAOIs and ergotamine. Advised to wait for at least 24 hours following use of ergotamine containing preparations or other triptan / 5HT1 receptor agonists before sumatriptan use. Advised to wait 6 hours post sumatriptan use before use of ergotamine containing products and 24 hours before triptan / 5HT1 receptor agonists. Serotonin syndrome reported in patients following co-administration with SSRIs, SNRIs and triptans. Risk of serotonin syndrome when co-administered with lithium. Pregnancy and lactation: Should only be considered if the expected benefits to the mother are greater than the possible risk to the foetus. Sumatriptan is excreted in breast milk. Minimise infant exposure by avoiding breast feeding for 12 hours after treatment. During these 12 hours, expressed milk should be discarded. Driving ability/use of machines: Drowsiness may occur as a result of migraine or its treatment with sumatriptan. Undesirable effects: Some symptoms may be associated with migraine. Common effects; Dizziness, drowsiness, sensory disturbance, transient blood pressure increases, dyspnea, nausea, vomiting, sensation of heaviness, myalgia, pain, sensations of heat, cold, pressure, tightness, weakness or fatigue; see SmPC for full list of side-effects. Overdose: Seek medical advice. Product Licence Holder: Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG (PL 17907/0240). Date of Authorisation: 08/05/09 Recommended Price: - £ 8.00, 2 Tablet Packs Date of Prescribing Information: 02.03.2015 P

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows monitoring of the benefit/risk balance of the medicinal product. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Bristol Laboratories Medical Information Department on Telephone: 0044 (0) 1442 200 922

Quality • Consistency • Excellence

www.bristol-labs.co.uk

REFERENCES1) British Association for the Study of Headache, 2007. Available at: http://www.migraineclinic.org.uk/

wp-content/uploads/2009/08/Bash-Guidelines.pdf. Accessed 05/11/2014.2) International Headache Society, 2013. The International Classification of Headache Disorders, 3rd edition Available at:

http://www.ihs-classification.org/_downloads/mixed/International-Headache-Classification-III-ICHD-III-2013-Beta.pdf. Accessed 05/11/14.3) Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders

with WHO’s Classification of Functioning, Disability and Health (ICF). J Headache Pain (2005) 6:429–440 WHO, 2012. Fact Sheet No. 277. Available at: http://www.who.int/mediacentre/factsheets/fs277/en. Accessed 05/11/2014.

4) Lipton RB, Bigal ME, Kolodner K, Stewart WF, Liberman JN, Steiner TJ. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003 Jul;23(6):429-40.

5) Migraitan® Patient Information Leaflet , December 2014.6) Migraitan® SPC, February 2015.7) NHS England. http://www.myhealth.london.nhs.uk/news-events/events/migraine-action-annual-conference-agm-2014. Accessed 05/11/14.8) NHS, 2014a. Available at: http://www.nhs.uk/Conditions/Migraine/Pages/Causes.aspx. Last reviewed: 14/04/2014. Accessed 05/11/14.9) NHS, 2014b. Available at: http://www.nhs.uk/Conditions/Migraine/Pages/Treatment.aspx. Accessed 05/11/14. Last reviewed 14/04/2014.10) Patient.co.uk, 2014. Available at: http://www.patient.co.uk/health/migraine-leaflet. Accessed 05/11/14.11) Steiner TJ, Scher AI, Stewart WF, Kolodner K, Liberman J, Lipton RB. The prevalence and disability burden of adult migraine

in England and their relationships to age, gender and ethnicity. Cephalalgia. 2003 Sep;23(7):519-27.12) The Migraine Association of Ireland. Available at: http://www.migraine.ie/health-professionals

andmigraine/the-migraine-attack/migraine-prodrome. Accessed 05/11/14.13) The Migraine Trust. Available at: http://www.migrainetrust.org/diagnosing-migraine. Accessed 05/11/14.14) WHO, 2010. Global Burden of Disease Survey. Available at: http://www.who.int/topics/global_burden_of_disease/en. Accessed 05/11/14.15) WHO, 2012. Headache disorders Fact sheet no.277. Available at: http://www.who.int/mediacentre/factsheets/fs277/en. Accessed 05/11/14. 16) Migraine - Patient.co.uk. Available at http://www.patient.co.uk/health/migraine-leaflet. Accessed 28 January 2015.

Date of preparation: March 2015 Code: UK/MIG/MTB24/03/2015

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