Medical malpractice related to drug-induced anaphylaxis

Abstract

Drug-induced anaphylaxis (DIA) is a highly paradoxical disorder involving a fatal response to medicines prescribed for therapeutic purposes. This study aimed to improve the awareness on DIA and to prevent errors through an analysis of lawsuit judgments. Sentenced judgments involving DIA from 1998 to 2017 using the database of the Korean Supreme Court Judgment System were collected. General characteristics, results, and recognized negligence of DIA litigation cases were analyzed. Of 27 lawsuit cases included, antibiotics (n = 6, 22.2%), radiocontrast media (n = 6, 22.2%), and non-steroidal anti-inflammatory drugs (n = 5, 18.5%) were the most common drugs that had caused DIA. Cardiac arrest was reported in 23 cases (85.2%). The median time interval from drug administration to diagnosis and from diagnosis to cardiac arrest were 7 (interquartile range, IQR = 0–35) and 5 minutes (IQR = 0–33), respectively, suggesting insufficient time to cope with anaphylaxis. Consequently, either death (n = 18, 66.7%) or ischemic brain injury (n = 9, 33.3%) occurred in all cases. Violation of duty of care was recognized in 19 cases (70.4%) with median awarded amount of $106,060 (IQR = $70,296–$168,363). The recognized negligence included inadequate observation after drug administration (n = 6), delayed or missed epinephrine administration (n = 6), ignoring a history of allergy or drug hypersensitivity (n = 6), and prescription error (n = 5). It is necessary to improve the awareness on DIA, because making a trivial error in any process of history taking, drug prescription and administration, observation, and/or emergency treatment may have fatal consequences that can lead to indemnity.

An Analysis of Judicial Cases Concerning Analgesic-Related Medication Errors in the Republic of Korea

“…In patients with a history of an allergic reaction to a specific drug, additional exposure to it may result in systemic anaphylaxis. 19 Similarly, in the TEN case, the patient showed systemic symptoms such as facial swelling, rash, and itching after AAP administration. These are not common upper respiratory infection (URI) symptoms, yet the patient was diagnosed with URI and the physician prescribed AAP again, without obtaining medication history.…”

“…In these cases, the physicians did not assess the patient’s history of allergic reactions to the drugs before prescribing the drugs. In patients with a history of an allergic reaction to a specific drug, additional exposure to it may result in systemic anaphylaxis 19 . Similarly, in the TEN case, the patient showed systemic symptoms such as facial swelling, rash, and itching after AAP administration.…”

<p>Medicolegal Consideration to Prevent Medical Malpractice Regarding Opioid Administration: An Analysis of Judicial Opinion in South Korea</p>

“…In patients with a history of hypersensitivity to a specific drug, additional exposure to that may result in anaphylaxis. 25 Therefore, history taking of drug hypersensitivity is very important. In addition, patients with liver or kidney disease can overdose inadvertently if their doses are not adjusted for impaired renal or hepatic drug clearance, with side effects occurring at doses considered safe for the general population.…”

Development and Validation of a Deep Learning Model for Detection of Allergic Reactions Using Safety Event Reports Across Hospitals

“…4 Patients in health care settings are at particularly high risk for developing an allergic reaction given their many new exposures. [5][6][7] Given that allergic reactions can cause patient harm 8 and result in malpractice litigation, [9][10][11] timely allergic event detection, monitoring, and characterization are critical for improving health care quality and patient safety. 6,12 Hospital safety event reporting systems, which collect voluntarily reported safety event data from frontline personnel, are integral to the detection of patient safety signals in health care.…”

“…Patients in health care settings are at particularly high risk for developing an allergic reaction given their many new exposures . Given that allergic reactions can cause patient harm and result in malpractice litigation, timely allergic event detection, monitoring, and characterization are critical for improving health care quality and patient safety …”