[Legal and ethical aspects of drug therapy]

Legally speaking, the administration of drugs for diagnostic and therapeutic purposes is, in fact, bodily injury which enjoys exemption from punishment only when it is justified and the patient has given his consent. In daily practice the application of relatively low-risk diagnostic drops ought to represent a part of the commission which the patient gives the ophthalmologist in seeking out his practice. The risk involved in diagnostically and therapeutically administered drugs must be reasonably related to the possible advantage to be gained. Therefore, a brief explanation to the patient and the securing of his consent are surely appropriate before the use of a mydriatic in cases with a dangerously narrow chamber angle. Rational therapy with drugs depends on knowledge of their effects. In our specialty this is by no means the case with all drugs. However, there are problems in verifying their efficacy. Personal, practical experience often leads to false conclusions and to perpetuation of the same mistakes. From retrospective studies we can only arrive at reliable conclusions in the case of obvious, gross effects; not even exploratory data analysis provides sure knowledge; at best it established hypotheses. Therefore, the most important means of testing drugs is the prospective controlled study with random distribution of patients into a control group and groups given the test substance. With the help of statistical methods, this leads from ignorance to secure knowledge. Members of the legal profession have expressed their misgivings about randomized studies, partially because they are not familiar with the state of our ignorance and the difficulties involved in testing pharmaceuticals.(ABSTRACT TRUNCATED AT 250 WORDS)