Medical, legal and ethical considerations in the use of drugs having undesirable side effects

Abstract

The essence of the medical, legal, and ethical considerations given to the use of drugs which may have some undesirable side effects is "...above all, do no harm." In the case of the oral contraceptive pill, this means that a physician must ask if the potential detrimental side effects of this contraceptive are greater or less than allowing a pregnancy occur. 1 of the more difficult problems is grappling with the unknown and unforseen long-term undesirable effects. In terms of legal considerations, much can be said in favor of developing health care no-fault laws. Major legal consideration should be given to the informed consent of the patient when using drugs which have undesirable side effects. Informed consent should include patient apprisal of the risk/benefit ratio. Drugs under clinical investigation should be given only when 1) the informed consent of the patient or his authorized repre sentative has been given; 2) the physician is convinced of his diagnosis; and 3) existing methods of treatment would not be satisfactory. The physician should not prescribe and experimental drug until he has obtained from reputable sources information concerning 1) animal experimentation; 2) previous clinical investigations; 3) dosage recommendations; 4) contraindications; 5) possible side effects; and 6) the safety and usefulness of the drug. The Dpartment of Health, Education, an Welfare is formulizing guidelines on human experimentation and is reviewing topics such as informed consent and no-fault insurance. It would also be useful to officially adopt a code of ethics governing therapeutic treatment.