The Pharmaceutical Journal
Vol 268 No 7202 p827-832
15 June 2002

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This report comes from the Association of the European Self-Medication Industry (AESGP) meeting held in Dublin from 5 to 7 June 2002. The Journal's attendance was supported by the Proprietary Association of Great Britain

European system devised to identify potential prescription to OTC switches

A taskforce of the Association of the European Self-Medication Industry (AESGP) has devised a flowchart (see also PDF* 55K) that it says can be used to decide whether chronic conditions are suitable for self-treatment with over-the-counter medicines.

Using this, it has decided that urge incontinence (overactive bladder), which affects nine million people in the United Kingdom may be suitable for OTC treatment with oxybutinin or tolterodine. Only 5 per cent of sufferers are diagnosed, of whom only 36 per cent receive drug treatment.

The taskforce also believes that hyper-cholesterolaemia may be suitable for preventive treatment if a statin with a suitable safety profile can be found.

Taskforce member Dr Alberto Paredes-Días (Wyeth Consumer Healthcare) said that a simple questionnaire made it easy for incontinence patients to distinguish between urge incontinence, stress incontinence and other conditions, some of them serious, that lead to incontinence or urinary frequency. Urge incontinence was not a progressive disease and, if treatment was restricted to women, there was no need to worry about prostate cancer and benign prostatic hyperplasia.

"We don't want patients in the OTC area with conditions that deteriorate with time. They need help from a pharmacist or doctor," Dr Paredes-Días said.

He believes that urge incontinence is suitable for OTC treatment because the condition is easily self-diagnosed and drugs such as oxybutinin and tolterodine have a good risk-safety profile. Their side effects are tolerable for most patients and once-daily controlled-release formulations significantly reduce the incidence and seriousness of the most troublesome — dry mouth.

Another taskforce member, Dr Stephen Mann (Johnson & Johnson/MSD Consumer Pharmaceuticals), said that switching cholesterol lowering agents from prescription control to OTC use would be a new type of switch, because the aim was to prevent, rather than treat, disease in asymptomatic patients. It was his view there was no great step from OTC smoking-cessation to the treatment of other risk factors.

Consideration should be given to changing hypercholesterolaemia to an OTC indication because current treatment targets were driven primarily by cost considerations, meaning that treatment was denied to many people who would benefit. The priority in Britain was for secondary prevention of CHD in people who had a coronary event risk of 30 per cent or more over 10 years. Primary prevention targets should be set at a risk factor of 15 per cent, he said, but screening was not favoured because it would identify more people for treatment than the country could afford to pay for.

"It would have to be a drug-by-drug assessment," Dr Mann said. "Efficacy is not an issue and it is cost-effective. The safety of every drug is different, but I believe that there are statins which are about to come off patent which have stood the test of time."

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