The recent decision of the MHRA to approve the switch of sumatriptan 50mg tablets from POM to pharmacy prescription (P) status indicated a major change in the provision of acute medications to migraine sufferers.
Triptans are acknowledged as the gold standard acute treatment for migraine in current management guidelines, and are widely prescribed in the UK.
Recent data indicated that 94 per cent of GPs currently prescribe triptans, with an average of 13.5 scripts per quarter for each GP.
The availability of sumatriptan 50mg in the pharmacy provides the patient with a wider choice of treatments they can purchase for migraine.
It may give them the opportunity to treat a migraine headache at an early stage, avoiding the need to consult with a GP and obtain a prescription.
It also offers the pharmacist the opportunity to develop their experience of managing customers with migraine and other headaches.
Effect on patients
This approval can be seen as good for the GP, who may see fewer migraine patients; the pharmacist, who can extend their skills and sales; and certainly for the manufacturer of sumatriptan.
However, we need to be sure this switch benefits the patient and overall public health before we can welcome it.
Migraine is a large public health problem. It is common, with an adult prevalence of 13-15 per cent. Migraine is also a high-impact illness that is unfortunately often managed poorly in primary care.
It is under-diagnosed by physicians and many patients do not consult a GP for care. Patients rely on OTC medications for migraine management.
Migraine is associated with high direct and indirect costs of care, estimated at £1.9 billion per year.
There is therefore a high unmet treatment need, and a good potential for the pharmacist to be able to improve migraine care in the community.
Triptans are effective acute treatments, but are associated with contraindications, special warnings and side-effects that must be taken into account before an OTC sale can be made. In particular, triptans are contraindicated in people with a risk of cardiovascular disease, significant liver and kidney disease and in pregnant and breastfeeding women.
In addition, sumatriptan cannot be used with MAOIs, other triptans and ergotamine.
A questionnaire was developed by the manufacturer and validated to provide an algorithm for the pharmacist to help them select patients suitable to receive sumatriptan. The questionnaire is in two parts.
Question and answer
The pharmacist asks a series of questions designed to identify high-risk patients who should be referred to a GP, to diagnose migraine from other headaches and to check on concurrent medications.
The patient completes a series of questions to check on their cardiovascular risk factors and other illnesses.
Sumatriptan can only be sold when a satisfactory response is obtained from both parts of the questionnaire.
A validation study was conducted to correlate pharmacists' decisions based on the questionnaire with the decisions of GPs who were experienced in treating migraine.
Results exhibited good correlation and indicated that the pharmacists were more conservative than the GPs in their decisions. This questionnaire has now been approved by the MHRA. The pharmacist must look out for medication overuse headache associated with triptan use. A primary care survey indicated that about 10 per cent of people prescribed triptans used inappropriate high amounts.
These patients were responsible for about 50 per cent of the total prescribed triptans.
However, the cost of sumatriptan (£7.99 for two tablets) from the pharmacist is considerably more than a prescription and may well drive high users to consult a GP.
Medication overuse headache is a problem with all acute migraine drugs, but is perhaps associated less with triptans than with other drugs.
These data support the switch of sumatriptan from POM to P status, and this principle has been supported by the major UK medical charities that deal with headache such as Migraine in Primary Care Advisors (www.mipca.org.uk) and the British Association for the Study of Headache (www.bash.org.uk).
Recently, evidence-based guidelines have been produced for pharmacists to help them recognise migraine and other headaches, deal efficiently with headache sufferers and provide appropriate treatments or advise them to consult a GP.
Use of these guidelines, together with the pharmacist questionnaire, should give the pharmacist the information they require to sell sumatriptan safely and effectively.
- Dr Dowson is headache specialist and director of the King's Headache Service, King's College Hospital, London
- The switch of sumatriptan 50mg tablets from POM to P status is to be welcomed.
- It should enable more migraine sufferers to be treated effectively than is the case at present.
- The safeguards built in to the process should also minimise potential problems associated with the drug.
- The switch provides the community pharmacist with an enhanced role in the management of migraine, as advocated by current management guidelines.
- A primary care headache team consisting of GPs, nurses, pharmacists and other healthcare providers is advocated to work together to optimise headache management in the community.
- Ongoing educational initiatives will be required to promote and maintain the role of pharmacists in headache management, and suitable courses are currently in development.
- Medicines and Healthcare products Regulatory Agency - www.mhra.gov.uk
- Dowson A J, Lipscombe S, Sender J et al. New guidelines for the management of migraine in primary care. Curr Med Res Opin 2002;18: 414-39.
- Data from the DIN-LINK database, CompuFile Ltd, February 2006.
- Steiner T J, Scher A I, Stewart W F et al. The prevalence and disability burden of adult migraine in England and their relationships to age, gender and ethnicity. Cephalalgia 2003; 23: 519-27.
- Lipton R B, Bigal M E, Kolodner K et al. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia 2003; 23: 429-40.
- Lipton R B, Goadsby P J, Sawyer J P C et al. Migraine: diagnosis and assessment of disability. Rev Contemp Pharmacother 2000;11:63-73.
- Bandolier. Migraine: costs and consequences. www.jr2.ox.ac.uk/bandolier/band67/b67-5.html
- Sumatriptan: Summary of Product Characteristics. GlaxoSmithKline: UK.
- Williams D, Cahill T, Dowson A et al. Usage of triptans among migraine patients: an audit in nine GP practices. Curr Med Res Opin 2002;18:1-9.
- Dowson A J, Dodick D W, Limmroth V. Medication overuse headache in patients with primary headache disorders: epidemiology, management and pathogenesis. CNS Drugs 2005;19:483-97.
- Glover C, Greensmith S, Ranftler A et al. Guidelines on headache management for use by the pharmacist. Pharmaceutical J 2006; in press.