This paper examines the legal and ethical dimensions of a fatal medication error case discussed in Hospital Pharmacy by Smetzer and Cohen (1998). A day-old infant died after receiving an intravenous dose of a medication labeled for intramuscular use only, compounding failures in parental consent, dosage interpretation, and route of administration. The paper identifies 50 latent and active system failures and analyzes the legal liability of the hospital, physician, pharmacist, and nurse. It also addresses the ethics of disclosure and apology, the systemic organizational weaknesses that enabled the error, and the administrative measures that could prevent similar tragedies, including the use of translators and improved medication-use protocols.
Various factors in the health care system contribute to medication errors. This paper reviews a case study discussed in Hospital Pharmacy (Smetzer and Cohen, 1998), which provides a clear example of the complex nature of the health care system, the medication-use process, and how these relate to medication safety and quality. In the case, a nurse made the decision to administer a medication intravenously, despite the syringe being labeled "IM use only." Administering the drug by IV proved lethal, as the drug is insoluble and obstructs blood flow to the lungs, preventing the transfer of oxygen to the infant's airways. After the baby died, it was determined that the infant had not actually required the treatment at all.
There were 50 latent and active failures that occurred during the medication-use process, and the majority of these failures were not under the control of the nurses. As the case study reports, "since most of what people do is governed by the system within which they act, the causes of errors belong to the system and often lie outside the control of individuals, despite their best efforts" (Institute of Medicine, 2007). The legal issues arising from this case stem from latent and active failures associated with key elements of the medication-use system.
First among the legal implications in this case is the hospital's failure to obtain parental consent before treating the infant. Second is the failure to administer the proper dosage and the proper route of delivery. The nurse's unauthorized change to the medication's delivery route constitutes a separate legal issue for the hospital. Under the laws of any U.S. state, a parent must provide informed consent for the medical treatment of a minor child. The hospital did not obtain such consent, and based on the information available in the case study, the parent would not have consented to this treatment had she been consulted.
The pharmacist bears a professional and legal responsibility when filling a prescription to question any order that is "not in the usual course of professional treatment" and must "exercise sound professional judgment" in doing so. The pharmacist should have been knowledgeable about the medication, and if uncertain, should have verified the prescription — either by contacting the physician or consulting reference materials — regarding the proper dosage for the infant. Failure on the part of the pharmacist is in direct violation of Drug Enforcement Administration regulations.
According to the ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control, "Any questions arising from a medication order, including the interpretation of an illegible order, should be referred to the ordering physician by the pharmacist" (2011). The same bulletin also states: "All medications should be administered by appropriately trained and authorized personnel in accordance with the laws, regulations, and institutional policies governing drug administration. It is particularly important that there are written policies and procedures defining responsibility for starting parenteral infusions, administering all intravenous medications, and adding medications to flowing parenteral fluids" (2011).
The nurse is also legally liable for having changed the route by which the medication was administered. Even though the nurse noted that something appeared wrong, she failed to consult the physician. The physician, for his part, is not legally liable for the dosage error, as he wrote the correct dosage, which was subsequently misinterpreted by the pharmacist. However, because the physician failed to obtain parental consent for the infant's treatment, he bears legal liability alongside the pharmacist, the nurse, and the hospital as a whole.
The provider failed to obtain the consent of the parents before treating the minor child. Had this consent been sought, the entire sequence of events — and the death of the child — could have been avoided. The ethical obligation to involve the family in treatment decisions was disregarded at every level, and this omission had fatal consequences.
"How provider apology affects legal exposure"
"Organizational reforms to prevent similar errors"
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