Drugs: from prescription only to pharmacy only.

sequence, and chromosomal mapping of a human flavin-containing monooxygenase (FMOl). primary sequence and chromosomal localization of human FMO2, a new member of the flavin-containing mono-oxygenase family. The benefits are clearer than the risks The range of medicines available over the pharmacy counter is set to increase. I The Medicines Control Agency has revised its procedures to speed up the reclassification from prescription only medicine (POM) status to pharmacy only (P) status. In addition, the Medicines Act has recently been revised to ensure, by five yearly review, that the prescription only status of a medicine continues to be justified. Economic and philosophical considerations underlie these moves. Economic considerations include an escalating growth in spending on health care, which includes a drug bill, growing at around 12% every year. One solution is to shift more of the financial burden to individuals by encouraging them to treat themselves with non-prescription drugs. What is more, the current controls on drug spending have constrained profits in the drug industry, so more companies are moving into the over the counter market.2 The govern-ment's philosophy on health care is that individuals should take greater responsibility for their health3; trends towards less medical paternalism and more consumerism favour greater freedom to choose self treatment for palliation and cure. All drugs have some potential to cause harm, and reclassifying some from prescription only to pharmacy only increases the community's exposure to hazard: although the secretary of state for health claimed that patients' safety would be a prime consideration,' how good are the data on safety? Clinical trials are usually done on a restricted range ofpatients under controlled conditions and may not predict what happens in general use. Postmarketing surveillance studies are often poorly planned and executed,4 and the Committee on Safety of Medicines collects only a small proportion of adverse effects. It can be difficult to extrapolate from similar changes in other countries. For example, in Denmark cimetidine was made available without prescription in 1989 and the pattern of adverse reaction reports did not change.5 Changes in reimbursement and advertising controls complicate interpretations of the change in status, and the amount of the drug sold over the counter was small, with much of it probably bought by patients who had previously been prescribed it. The true effect on the community will not be seen until the drug is widely purchased by people who are taking drugs with which cimetidine …