The Pharmaceutical Journal
Vol 270 No 7233 p116-117
25 January 2003

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Letters to the Editor

Appliances and devices

Generic specifications for standard products needed

From Dr R. J. Schmidt, MRPharmS

Cost optimisation of National Health Service resources is a key policy aim of the Department of Health — hence the establishment of the National Institute for Clinical Excellence and the clinical and cost effectiveness branch of the DoH.

From the point of view of the community pharmacist, monies saved by rational and intelligent prescribing represent monies that presumably would instead become available in the global sum to pay for the delivery of community pharmaceutical services.

We may suppose that generic prescribing of medicinal products is now at as high a level as can reasonably be expected. But it cannot have escaped the notice of community pharmacists that prescribing of appliances and medical devices (ie, products listed in Part IX of the Drug Tariff) has, over the past 20 years or so, increasingly moved away from generic prescribing.

Ostensibly, the reason for this move towards prescribing of appliances by brand name seems to be that manufacturers of some categories of appliance have developed products for which no generic pharmacopoeial or Drug Tariff specification or indeed convenient generic descriptor exists. Once listed in the Drug Tariff these products are prescribable only by brand name because even where a generic descriptor is available, this is usually too cumbersome for prescribers to remember.

However, the real reason for this change may be that the DoH decided some time ago to stop producing and maintaining specifications for the burgeoning number of products in the various categories of appliance listed in the Drug Tariff, relying instead on the CE marking system as a means by which compliance with a specification is ensured. A CE mark indicates that the product complies with all relevant standards applicable to the manufacture of that type of product. But if no Drug Tariff or pharmacopoeial specification exists, manufacturers are not obliged to ensure that the product meets an acceptable performance or quality standard. So manufacturers are in effect encouraged to develop products that are differentiated for marketing purposes but which do not necessarily meet any recognised clinical performance or quality standard.

As a result, we now have a multitude of "me-too" products in certain categories of Part IX of the Drug Tariff, all differing from one another in some minor detail that confers little if any clinical advantage, all being promoted by the manufacturers as branded products. Because they need to be vigorously promoted to ensure their sales, the cost of these products is inflated with obvious consequences as regards the global sum (of which some £400m per annum is spent on appliances).

Because prescribing of appliances by brand name is now considered normal, we have a ridiculous situation where, for example, elasticated tubular bandage BP is virtually never prescribed because almost all prescribers choose instead to write prescriptions for Tubigrip even though this particular brand of elasticated tubular bandage BP is the most expensive of the six listed brands. Several other such examples may be cited.

Surely the time has come for Part IX of the Drug Tariff to be rationalised through the creation, where necessary or possible, of generic specifications for all standard products and the de-listing of essentially equivalent branded products in those categories. It would of course be necessary to provide convenient and memorable generic descriptors for these categories.

In this way, a "black-list" would be created of branded products that would remain prescribable only by generic descriptor. Market forces would then quickly result in lower prices, with an obvious impact on that part of the global sum that is currently being spent on the promotion of expensive branded appliances and which could instead be spent on the delivery of community pharmaceutical services.

To encourage generic prescribing of medicinal products on the one hand while at the same time allowing a situation to develop in which appliances are prescribed only by brand name is at best inconsistent and at worst inept. I would be interested to hear either how the clinical and cost effectiveness branch of the DoH justifies the status quo or whether it has any plans to change along the lines suggested above.

Richard J. Schmidt
Barnoldswick, Lancashire

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