Over the counter sale of topical corticosteroids: the need for debate.

Abstract

Not long ago at a conference of consultant dermatologists I presented the case against making hydrocortisone an over the counter (OTC) product. After debate the case against won the day by 34 to 31 votes. A narrow margin, but it was an impressive victory; before the debate all the dermatologists that I questioned had said that licensing hydrocortisone as an OTC product was "probably all right."Several pharmaceutical companies are keen to introduce 1% hydrocortisone as a topical product for sale to the public without prescription. To achieve this, approval would have to be obtained for licensing it as an OTC product. Applications have been rejected in the past but the industry-no doubt looking for ways to recover from recent ill considered government attempts to reduce its profitability-is applying considerable pressure to secure approval because market research suggests that the sales potential is large.The introduction of OTC hydrocortisone would not only affect dermatologists: general practitioners and other physicians would inevitably have to deal with many of the problems that its unlimited use would bring. So here I present the meat of the debate that took place among the dermatologists and leave the general reader to form his or her own opinion.The case for OTC hydrocortisoneThe case in support of OTC hydrocortisone is a simple one. Minor skin complaints are common, most are transient, and many go unreported. Most, it is alleged, could be treated effectively and safely with 1% hydrocortisone. Rashes that do not respond to topical hydrocortisone do not matter, either because they will ultimately remit spontaneously or because the patient will eventually report to the family doctor. Self treatment of trivial dermatoses would save time both for the patient and the doctor, and save money.Two other threads in the case flow in opposite directions. One says that OTC hydrocortisone is a logical extension of self medication; the other that hydrocortisone is largely ineffective, and thus its unsupervised use is of no importance. Many dismiss the possibility that hydrocortisone will cause appreciable side effects. The case against OTC hydrocortisoneThe case against OTC hydrocortisone is based on both the weakness of the case for it and the disadvantages that its introduction would bring. Hydrocortisone is an active natural substance and it is the hormone that saves each and every one of us from Addisonian crisis. Applied topically to the rat 1% hydrocortisone reduces specific glucocorticoid cytosol receptors in the skin by 70-80%; put on normal human skin it produces vasoconstriction. The effects of topical 1% hydrocortisone are primarily local, but occasionally systemic absorption occurs. If OTC preparations are licensed and many people are exposed, iatrogenic Cushing's syndrome will be induced, albeit rarely. The very young are particularly at risk because of their high surface area/body mass ratio, as are patients with abnormal skin that allows increased absorption, and those with impaired hepatic metabolism.Ill e...