Decision-making process for supply

You’ll need to use your professional judgement when dealing with requests (see our professional judgement guide).  

It’s important to share information about the process of supply with the person requesting. Explain that you’ll need to ask some questions to make sure the medicine is suitable for them. And that you may need to refer them to a prescriber if you identify contraindications or if investigations are required. 

You may want to use the following questions to support diagnosis, prescreening, education and supply. Explore the person’s situation by considering and asking the following:  

• Who’s requesting a supply? Is it the person who needs the medicine or a representative?
  • Supply to the person needing the medicine – is the person needing the medicine aged between 18 and 65 years old? Ensure you are supplying the medicine within the marketing authorisation.
  • Supply to the person’s representative – see section on supplying to a person’s representative.
• Does the person have symptoms of migraine with or without aura, or have they been diagnosed with migraine before (see the section on migraine)? Are there any other symptoms that may indicate differential diagnosis, such as tension headaches (see the National Institute for Health and Care Excellence’s Clinical Knowledge Summaries (CKS) page) or require referral for further investigation?
• Is the person hypersensitive to any of the active ingredients or excipients in sumatriptan tablets OTC, including sulphonamides?
  • Sumatriptan OTC is contraindicated if there is hypersensitivity to the active substance or any excipients listed.
• Does the person have underlying risk factors for ischaemic heart disease?
  • Discuss possible risk factors and address any issues.
• Do they have any health or medical conditions and are they taking any medicines?
  • Check for contraindications, interactions and any reason for referral under the summary of product information.
• Have they been supplied sumatriptan OTC before?
  • Check if they experienced any side/adverse effects that would require referral to a prescriber and see the repeat supply section.
• Have they requested sumatriptan OTC in the past and been refused, or had to stop treatment for any reason?
  • Find out why and use your professional judgement to decide if that’s a reason for referral.  
• Have they already been prescribed sumatriptan or any other triptan?
• Sumatriptan can still be purchased OTC if more practical (e.g. they are unable to get a suitable appointment with their prescriber). But, consider if an emergency supply of the person’s prescribed medicine is more appropriate (e.g. if they are being prescribed off-licence or are taking an alternative dose or strength). See our guide on emergency supply. 
• Are they aware of all the other options available to them?
  • See the section on alternative treatment options.
• Use your professional judgement to decide on suitable action:
  • If you feel the supply is suitable and the person requesting the medicine is happy to continue, provide counselling and any relevant information using the summary of product information section.
  • If you feel the supply isn’t suitable, if in doubt of suitability or if medical attention, investigations or a referral is required, then refer to a prescriber. 

For further information, see the relevant product SPC and PIL, found under further information.

Quantity to supply and repeat requests 

There is no limit on the number of packs that you can sell. 

However, you should use your professional judgement on a case-by-case basis to decide if a frequent or multiple-pack supply to the same person is appropriate. 

Repeats 

You need to be satisfied that the medicine is still clinically appropriate and suitable on each occasion, and check if anything has changed since the last supply. You can ask to see if the person has evidence of the initial/previous consultation or supply, (e.g. a slip to confirm where and when the consultation took place). This will determine if a repeat supply is suitable or if they’ll need a full consultation. 

Consider the following questions to assess continued suitability: 

• Who is requesting the supply? How old are they?
  • Ensure that the person is aged 18-65 years old.
• How often do they need to use this medicine, and is there any improvement with use?
  • Refer the person if their symptoms don’t improve or worsen, or if they are using it daily or frequently (four or more times per month).
• Have there been any changes in their health or medical conditions or medicines since their last supply?
• Have there been any changes to their medicines (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational, alcohol and tobacco) since their last supply? 
• Have they experienced any side effects or signs and symptoms of adverse effects?
  • Serious side/adverse effects may require immediate withdrawal and referral to the prescriber. 

If you feel the supply is no longer suitable, if in doubt of suitability or if medical attention, investigations or referral is required then refer to a prescriber. 

If you feel the supply is suitable then provide counselling. 

Supply to the person’s representative  

Sumatriptan OTC can be supplied to a representative. However, it is important that you only supply the product:  

• Within the marketing authorisation.
• If you’re satisfied that it’s a genuine request .
• If the treatment is clinically appropriate for the person. 

You’ll need to use your professional judgement with requests from representatives. 

Consider the following:  

• Who is requesting on the person’s behalf and why?  
• How will you ensure that the treatment is clinically appropriate for the person needing the medicine (e.g. check contraindications, referrals, previous medical history and existing medicines)?
• How can you get in touch with the person to assess suitability and determine whether the request is appropriate and genuine (e.g. by telephone)?
• Be careful not to disclose to the representative what was previously discussed, unless you have consent from the person needing the medicine  .
• Are you supplying the medicine within the marketing authorisation (e.g. ensure that the person is aged 18-65 years old and has symptoms of, or previously been, diagnosed with migraines by a doctor or pharmacist)?

Counselling 

Discuss the following: 

• The condition – explain the condition and what causes it to empower the person to understand better. 
• Alternative treatments – provide information on alternative treatment options (see the section on alternative treatments).
• The medicine – what it is, how it works and how to use it (importance of adherence).
• Side/adverse effects and risks – make sure the person is aware of what signs and symptoms of adverse effects to look out for and when to seek medical attention and advice.
• Interactions – make sure the person knows to check interactions with a pharmacist before starting any new medicines (see the section on interactions).
• Referrals – make sure the person is aware when to see a prescriber.
• Risk factors – where risk factors for ischaemic heart disease are identified, offer advice to prevent any future events (see the section on when to refer).
• Migraine diary – keeping a migraine diary may help some people to identify personal trigger factors (e.g. food, stress, caffeine or alcohol). For further information, see the NHS website.
• Effects on driving – may cause drowsiness.
• Health promotion – provide lifestyle and wellbeing advice where appropriate, including diet, exercise, smoking cessation, reducing alcohol, and stress and weight management. 

For further information on counselling and when to refer, see the British National Formulary (BNF) and relevant product SPC and PIL.

You may also find our pharmacy guide on counselling people on the use of medicines useful. 

Additional considerations

Here are some further points to consider when supplying:

• Record-keeping – see the section on record-keeping.
• Quantity to supply how to obtain further supplies – make sure the person is aware of how to obtain further supplies.
• Online purchases – highlight the risks of purchasing medicines online:
  • If buying from unregulated resources, the medicines may not be tested for safety or effectiveness. 
  • Advise the person to check that the medicine is being supplied from a reputable provider before purchasing – see guidance from the General Pharmaceutical Council (GPhC).
• Online pharmacies – will need to meet GPhC regulatory standards for providing services at a distance (see the GPhC guidance on providing pharmacy service at distance, including on the internet, and GPhC premises standards).
• Storage and disposal – advise the person to return any unused medicines to a pharmacy for disposal.
• Delivering and posting medicines – the Medicines, Ethics and Practice (MEP) guide covers some additional points about delivering and posting medicines to patients. 

Record-keeping 

There is no legal requirement to record the supply of a P medicine. However, professionally, you may decide to make a record of the following for audit purposes: 

• Referrals 
• Discussions 
• Advice you gave about when and how to seek help if needed, i.e., safety netting.
• Reasons for the advice you gave.
• Repeat sales 
• If the person asked you to contact their prescriber
• Interaction checks

If you decide to make a record, make sure you get the person’s consent (see the GPhC’s guidance on confidentiality and consent). 

Our pharmacy guide on clinical documentation may also be useful.

Summary of product information

The table below provides some product information on sumatriptan 50mg tablets for supply as P medicines.

Refer to the full up-to-date product details in the relevant SPC and the BNF, which can be found under further information.

Indication	– Treatment of acute migraine (with or without aura). – Migraine must be diagnosed by a prescriber or pharmacist. – For use in people 18-65 years old.
Dose	– Take one 50mg tablet at the first signs of a migraine, if possible. – If there is a second migraine attack within 24 hours, a second dose may be taken two hours after the first dose. – Maximum dose is two tablets a day (24 hours). – Take with water. – Not to be used preventatively or pre-emptively.
When to refer	People should be referred to a clinician/prescriber if there is any doubt the medicine is suitable for them and there are no other alternative OTC products available, or if the person:  – Experiences any side effects – Has a contraindication – Is taking or using medicine(s) that has a clinically significant interaction with sumatriptan – Has no improvement of symptoms after taking sumatriptan – Has a history of seizures – Has a renal or hepatic impairment Refer if the person’s symptom history includes: – Headaches lasting over 24 hours – More than four attacks per month – They don’t fully recover between migraine attacks – Symptoms have changed or symptoms get worse – Their first migraine occurring after the age of 50 – Unilateral motor weakness – Double vision – Clumsy and uncoordinated movements – Tinnitus – Reduced level of consciousness – Seizure-like movements – Rash with headaches Refer if the patient characteristics include: – A risk of heart disease – Three or more cardiovascular risk factors (e.g. a man over 40 years old, post-menopausal women, overweight, has diabetes, high cholesterol, family history of heart disease, smokes (more than ten per day) or use of nicotine substitution therapies)
Contraindications	Sumatriptan OTC is not recommended and the person should be referred if they are:  – Using the medication preventatively or pre-emptively. – Hypersensitive or allergic to sumatriptan or any of the other ingredients, including sulfonamides. – Over 65 years old. – Under 18 years old. – Taking or using medicine(s) that has a clinically significant interaction with sumatriptan. – Pregnant or breastfeeding. – Not diagnosed with migraine by a prescriber or pharmacist. Or in people with: – Cerebrovascular accident (stroke) – Coronary vasospasm (Prinzmetal angina) – Ischaemic heart disease – Myocardial infarction (MI) or symptoms of MI (e.g. chest pain/shortness of breath) – Peripheral vascular disease – Severe hepatic impairment – Transient ischaemic attack (mini stroke)  – Uncontrolled/moderate/severe hypertension – Hemiplegic migraine – Basilar migraine – Ophthalmoplegic migraine
Side/adverse effects	Common: – Dizziness – Drowsiness – Sensory disturbance  – Increased blood pressure (transient) – Flushing – Breathlessness – Nausea and vomiting  – Feeling of heaviness, pressure or tightness (transient) – Muscle aches – Pain – Weakness and fatigue (transient) – Report any suspected side effects, as appropriate, via the Yellow Card scheme on the Medicines & Healthcare products regulatory agency website. See our Yellow Card scheme guide for further details.
Interactions	People should be aware if taking:  – Ergotamine (and its derivatives, e.g. methysergide) – increased risk of coronary vasospasm (contraindicated).  – Monoamine oxidase inhibitors (MAOIs) – increased risk of serotonin syndrome. (contraindicated). You need to wait two weeks after stopping/discontinuing MAOIs before you take sumatriptan. – 5-HT1 receptor agonists (triptans) – increased risk of serotonin syndrome (contraindicated).  – Selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitors – risk of serotonin syndrome (precautions for use, speak to prescriber first).  – Combined oral contraceptives – increased risk of stroke (precautions for use), speak to a prescriber first and refer to a prescriber if the migraine started recently or symptoms have got worse. – St-John’s wort – increased risk of side effects (precautions for use, speak to prescriber first).
Pregnancy and breastfeeding	– Cannot be used in if breastfeeding. – Cannot be used in pregnancy.
Age	– For use in adults between 18-65 years old.
Storage	– See SPC or PIL.

Migraine 

• Pre-warning symptoms – starting hours or one to two days beforehand and can include tiredness, yawning, mood changes and stiff neck.
• With or without aura – sensitivity to light, sounds and smells, flashing lights, numbness or tingling, dizziness, difficulty speaking.
• With or without moderate to severe headache – lasting 4–72 hours, unilateral, throbbing.  
• Nausea and/or vomiting.

Migraines can last between two hours and three days.

Some causes include:

• Menstruation
• Dehydration
• Stress and tiredness
• Skipping meals
• Caffeine

Alternative treatments  

People should also be made aware of all treatment options available in addition to sumatriptan OTC, as something else may be more suitable. Consider referring the person to their doctor if they have underlying risk factors, or if alternate treatments are more suitable. 

Other drug treatments and non-medical treatments include paracetamol, aspirin or non-steroidal anti-inflammatory drugs, where appropriate to treat symptoms.

Depending on the severity and frequency of migraine, other triptans, different formulations of triptans, antiemetics or prophylactics may be more suitable and need referral from a prescriber.

Non-drug treatments may also be helpful (e.g. acupuncture, relaxation techniques to manage stress, sleeping in a dark room during an attack, avoiding triggers, staying hydrated, limiting caffeine and alcohol, maintaining a healthy weight and exercising). 

Confidence in consultation skills 

Discussing symptoms of migraine may be uncomfortable for some people, who may feel nervous approaching the pharmacy team. To ensure comfort and confidence, the pharmacy team should always be discreet, non-judgemental and put the person at ease. 

If a request needs to be referred to you by counter staff, they’ll need suitable training to handle such circumstances, since they’re usually the first point of contact. Referrals should also be covered in the standard operating procedure.

To support these conversations, good communication is essential. Develop your confidence with practical tips and information in our consultation skills pharmacy guide. You may also find our resource on facilitated self-selection of P medicines helpful.

Further information 

RCPharm:

• Clinical documentation
• Confidence in consultation skills
• Counselling people on the use of medicines
• Emergency supply
• Facilitated self-selection of P medicines
• MEP
• Professional judgement
• Yellow Card scheme

External resources:

• NHS.UK
• Patient
• NICE CKS
• electronic medicines compendium – SPC and PIL
• BNF

Consultation skills:

• Centre for Pharmacy Postgraduate Education
• Health Education and Improvement Wales
• NHS Education for Scotland