Nurses often administer drugs to patients for treatment and research purposes, at the direction of physicians, without knowing their legal responsibilities. Following a doctor's orders is not an adequate defense for a nurse against a lawsuit based on the administration of a drug not approved by the Food and Drug Administration (FDA); administration of a drug approved by the FDA, but approved only for a different purpose; or administration of a drug without the informed consent of a patient. Considerable confusion exists about a nurse's legal obligations in administering “new drugs,” and the purpose of this article is to provide some clarity.

The regulation of the use and distribution of drugs in the United States is governed by a complex set of state and federal laws and regulations. These laws and regulations are designed to accomplish a variety of purposes. First, the federal government hopes to exclude from interstate commerce drugs that are not both “safe and effective.” This function is performed by the United States Food and Drug Administration, exercising its authority under the Food Drug and Cosmetic Act and involves, for the most part, regulating the manufacturers of drugs. Second, both state and federal laws and regulations exist to keep “controlled substances” out of the hands of individuals who would use (or abuse) such substances for recreational as opposed to therapeutic purposes. The regulation of the use of such substances is primarily accomplished by the federal Controlled Substances Act (CSA) and similar laws that exist at the state level. Third, some drugs, because of their toxicity or habit-forming qualities, are prohibited from public consumption without the guidance of a health care professional. Unlike over-the-counter drugs which may be purchased by anyone, these drugs may only be purchased by a consumer who presents a valid prescription to a pharmacist.

The task that has perhaps most preoccupied professional nursing is that of defining itself. Over the years nursing has developed in such a way that currently there is a vast disparate group of individuals, each of whom may properly be called “nurse” — ranging from the licensed practical nurse to the nurse who holds a doctoral degree, with at least four levels of academic preparation between. It is evident that this situation poses problems, not only for nursing but also, and more importantly, for health care consumers who are unable to establish realistic expectations as to the knowledge and skills of “nurses.”

Novella Trageser was hired by Libbie Rehabilitation Center in 1971, and in 1975 Libbie promoted her to Director of Nurses. She performed her duties capably, despite the fact that she had retinitis pigmentosa. During an inspection in 1976, a state certification officer from the Department of Health informally indicated disapproval of her employment because of her handicap. The home administrator relayed these comments to the board of directors, which resolved to dismiss her. Upon learning of this decision, Novella Trageser resigned and brought suit against the nursing home, partially on the basis of section 504 of the Rehabilitation Act.