UK pilot allows pharmacists to supply sildenafil without prescription

BMJ 2007; 334 doi: (Published 22 February 2007) Cite this as: BMJ 2007;334:387
  1. Susan Mayor
  1. London

    Doctors are welcoming a pilot study launched in an English city last week in which men with erectile dysfunction can buy sildenafil (Viagra) directly from community pharmacists rather than having to be prescribed the drug by a doctor. But they feel the scheme does not tackle the inequity of the present system, under which some male patients are able to obtain the drug free on the NHS while others are excluded from free treatment. Some experts also object to the fact that the scheme is limited to only one drug.

    Three pharmacies—part of the Boots chain—in Manchester are piloting the new service, which involves an initial screening with a pharmacist and long term follow-up for men wanting ongoing provision of sildenafil. The potential for the scheme to be extended across the UK will be assessed later this year.

    Geoffrey Hackett, a GP and consultant urologist at Good Hope Hospital in Sutton Coldfield and president of the British Society of Sexual Medicine, argued that more men should be eligible for treatment on the NHS. Drug treatment can be provided only to patients whose erectile dysfunction is due to specified causes, including diabetes, multiple sclerosis, and major pelvic surgery, and where it causes severe distress, as assessed by a specialist.

    Dr Hackett said, “Erectile dysfunction should be reclassified as peripheral arterial disease. Treating peripheral vascular disease in the feet and toes in patients with diabetes is an NHS priority. So why is disease affecting another set of peripheral vessels not considered as important?”

    He also considered that the Boots programme limits treatment options, “Patients are entering into a consultation where there is only one possible treatment option. But Viagra is only one of the treatment options for erectile dysfunction. Patients should be assessed for the best treatment for them.”

    A spokesperson for Boots said, “We make it very clear in our programme that we are only checking if one particular treatment (Viagra 50 mg) works for that patient. We chose Viagra as it has a longer licence than the other treatments available and so more safety data was available.

    “If the treatment is not suitable, or if it is not effective for the patient, then they would be referred back to their GP for further investigation. We also have a leaflet containing information on other treatment options available to patients.”

    Patients wishing to join the Boots programme, which is open to men aged 30-65, have to be registered with a UK doctor and have to have an initial consultation with a pharmacist. This follows a strict protocol to assess their suitability for treatment with sildenafil.

    The consultation includes taking a medical history, establishing patients' symptoms of erectile dysfunction, and checking their blood pressure, cholesterol, and blood glucose. The pharmacist also asks about any other medications—including nitrates, which are contraindicated for concurrent use of sildenafil—and about medical conditions that affect patients' suitability for the drug. Patients meeting the criteria are then supplied with an initial four tablets of sildenafil.

    Men wanting to receive a continued supply of sildenafil are then required to have a consultation with a private doctor, which is arranged by Boots, for a further medical and physical examination to assess their suitability. Results of all consultations, with the pharmacist and private doctor, are communicated back to the patient's GP.

    Alex Gourley, director of healthcare with Boots, said, “By creating a service that is easily accessible on the high street we hope that we help many more men seek help for a very common condition.” He noted that only 10% of the estimated three million men in the UK with erectile dysfunction are currently being treated. He added that the programme also showed “the potential that a pharmacy has to extend treatment and advice on health care to patients with a wide range of conditions.”

    A spokeswoman for the BMA said: “The BMA has always criticised this unjust and unfair system [under which only some patients are eligible for the drug]. If Viagra (or the competing drugs) was universally available on the NHS for erectile dysfunction there would be no need for a system such as the Boots one. Patients with a clinical need for treatment would then only have to pay the NHS prescription fee.”

    Boots reported that initial customer response has been extremely positive. “We've received hundreds of phone calls for further information and are nearly fully booked for consultations in the first week,” said a spokesperson.

    The new programme is the fourth of its kind for Boots, which offers similar pharmacy programmes for weight loss (including a supply of orlistat), hair retention (with a supply of finasteride (Propecia)), and chlamydia (including provision of free azithromycin or doxycycline). They all make use of private patient group directions, in which health professionals other than doctors can prescribe medicines for a defined group of people under waivers signed off by local health managers.

    The erectile dysfunction programme costs £50 (€74; $98)for the initial screening and supply of four sildenafil tablets, £37.50 for the consultation with the private doctor, and then £21.25 or more for each further supply of four tablets. This contrasts with free consultations with patients' NHS GPs and a prescription charge of £6.65, although people over the age of 60 and those with chronic conditions such as diabetes requiring medication, in which erectile dysfunction is common, are exempt from this charge.

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