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Medicolegal Consideration to Prevent Medical Malpractice Regarding Opioid Administration: An Analysis of Judicial Opinion in South Korea.

ABSTRACT: Purpose:Although the use of opioids is increasing in South Korea, there have been no studies on the serious complications caused by the opioids. The aim of this study was to investigate the rare but serious complications through medicolegal analysis. Materials and Methods:From January 1994 to December 2019, we retrospectively reviewed the closed cases of lawsuits involving the complications of opioids using the database of judgments of the Supreme Court of Korea. General characteristics, opioid-induced complications, and judicial characteristics were analyzed. Results:Of the 46 cases, 31 cases of complications were finally included in the analysis. There were 28 (90.3%) cases of opioid administration for acute pain and 3 (9.7%) cases for chronic pain. The most commonly prescribed opioid was pethidine (n = 13, 41.9%), and the most common complication was respiratory depression (n = 17, 54.8%). All except two cases were associated with permanent injuries, including 18 (58%) deaths. Twelve (38.7%) cases were ruled in favor of the plaintiff in the claims for damages, with a median payment of United States dollar (USD) 126,346 (IQR: USD 77,275-379,219). Of these cases, the most frequently admitted complaint by the court was the neglect of observation (n = 10, 32.3%), followed by the inappropriate drug choice (n = 4, 12.9%). Eleven (36.7%) cases were plaintiffs' claims for violating explanation obligations, of which 2 (6.7%) were recognized in the court. Conclusion:Our results suggest that physicians must be aware of the serious complications related to opioids and health policies to prevent such complications and malpractice should be adopted.

SUBMITTER: Kim J

PROVIDER: S-EPMC7323961 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Medicolegal Consideration to Prevent Medical Malpractice Regarding Opioid Administration: An Analysis of Judicial Opinion in South Korea.

Kim Jeongsoo J Shin SuHwan S Jeong YoungHyun Y Kim So Yoon SY Lee Ho-Jin HJ

Journal of pain research 20200625

<h4>Purpose</h4>Although the use of opioids is increasing in South Korea, there have been no studies on the serious complications caused by the opioids. The aim of this study was to investigate the rare but serious complications through medicolegal analysis.<h4>Materials and methods</h4>From January 1994 to December 2019, we retrospectively reviewed the closed cases of lawsuits involving the complications of opioids using the database of judgments of the Supreme Court of Korea. General character ...[more]

PMID: 32612380

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Project description:BackgroundDespite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter.MethodsWe conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanumab's approval, (2) identify any evidence of reputational injury to the Food and Drug Administration, and (3) explore opinions regarding policy responses available to policymakers, such as those relating to a national coverage determination by the Centers for Medicare and Medicaid Services. The survey was administered online and in English and Spanish using a probability-based sample derived from the National Opinion Research Center's AmeriSpeak® panel. Selection probabilities in the panel and survey design account for differences in population distribution and expected response rates by demographic. The survey was analyzed using survey weights to adjust for selection probabilities and non-response.ResultsA total of 1025 respondents completed the survey. While approximately three-quarters of respondents were initially unfamiliar with aducanumab, respondents were less supportive of the drug's approval once given information about the drug's potential clinical and economic impact. Sixty-three percent of respondents support restricting aducanumab access to patients most likely to benefit. Seventy-one percent indicated a willingness to enroll a family member with mild Alzheimer's disease in a "waitlist"-style trial to further study aducanumab; sixty percent indicated a willingness to enroll a family member in a randomized placebo-controlled trial. Eighty-one percent agree aducanumab should be withdrawn from the market if confirmatory trials fail. The median respondent was willing to pay $1-5 in higher Part B premiums to cover aducanumab.ConclusionThese findings demonstrate support for a range of proposed policies in response to aducanumab's approval. The opinions of an informed public ought to be considered when developing policies in response to aducanumab's approval.

Project description:ObjectivePain remains insufficiently treated in hospitals. Increasing evidence suggests human factors contribute to this, due to nurses failing to administer opioids. This behavior might be the consequence of nurses' mental models about opioids. As personal experience and conceptions shape these models, the aim of this prospective survey was to identify model-influencing factors.Material and methodsA questionnaire was developed comprising of 14 statements concerning ideations about opioids and seven questions concerning demographics, indicators of adult learning, and strength of religious beliefs. Latent variables that may underlie nurses' mental models were identified using undirected graphical dependence models. Representative items of latent variables were employed for ordinal regression analysis. Questionnaires were distributed to 1,379 nurses in two London, UK, hospitals (n=580) and one German (n=799) hospital between September 2014 and February 2015.ResultsA total of 511 (37.1%) questionnaires were returned. Mean (standard deviation) age of participants were 37 (11) years; 83.5% participants were female; 45.2% worked in critical care; and 51.5% had more than 10 years experience. Of the nurses, 84% were not scared of opioids, 87% did not regard opioids as drugs to help patients die, and 72% did not view them as drugs of abuse. More English (41%) than German (28%) nurses were afraid of criminal investigations and were constantly aware of side effects (UK, 94%; Germany, 38%) when using opioids. Four latent variables were identified which likely influence nurses' mental models: "conscious decision-making"; "medication-related fears"; "practice-based observations"; and "risk assessment". They were predicted by strength of religious beliefs and indicators of informal learning such as experience but not by indicators of formal learning such as conference attendance.ConclusionNurses in both countries employ analytical and affective mental models when administering the opioids and seem to learn from experience rather than from formal teaching. Additionally, some attitudes and emotions towards opioids are likely the result of nurses' cultural background.

Project description:ImportanceOpioids administered to treat postsurgical pain are a major contributor to the opioid crisis, leading to chronic use in a considerable proportion of patients. Initiatives promoting opioid-free or opioid-sparing modalities of perioperative pain management have led to reduced opioid administration in the operating room, but this reduction could have unforeseen detrimental effects in terms of postoperative pain outcomes, as the relationship between intraoperative opioid usage and later opioid requirements is not well understood.ObjectiveTo characterize the association between intraoperative opioid usage and postoperative pain and opioid requirements.Design, setting, and participantsThis retrospective cohort study evaluated electronic health record data from a quaternary care academic medical center (Massachusetts General Hospital) for adult patients who underwent noncardiac surgery with general anesthesia from April 2016 to March 2020. Patients who underwent cesarean surgery, received regional anesthesia, received opioids other than fentanyl or hydromorphone, were admitted to the intensive care unit, or who died intraoperatively were excluded. Statistical models were fitted on the propensity weighted data set to characterize the effect of intraoperative opioid exposures on primary and secondary outcomes. Data were analyzed from December 2021 to October 2022.ExposuresIntraoperative fentanyl and intraoperative hydromorphone average effect site concentration estimated using pharmacokinetic/pharmacodynamic models.Main outcomes and measuresThe primary study outcomes were the maximal pain score during the postanesthesia care unit (PACU) stay and the cumulative opioid dose, quantified in morphine milligram equivalents (MME), administered during the PACU stay. Medium- and long-term outcomes associated with pain and opioid dependence were also evaluated.ResultsThe study cohort included a total of 61 249 individuals undergoing surgery (mean [SD] age, 55.44 [17.08] years; 32 778 [53.5%] female). Increased intraoperative fentanyl and intraoperative hydromorphone were both associated with reduced maximum pain scores in the PACU. Both exposures were also associated with a reduced probability and reduced total dosage of opioid administration in the PACU. In particular, increased fentanyl administration was associated with lower frequency of uncontrolled pain; a decrease in new chronic pain diagnoses reported at 3 months; fewer opioid prescriptions at 30, 90, and 180 days; and decreased new persistent opioid use, without significant increases in adverse effects.Conclusions and relevanceContrary to prevailing trends, reduced opioid administration during surgery may have the unintended outcome of increasing postoperative pain and opioid consumption. Conversely, improvements in long-term outcomes might be achieved by optimizing opioid administration during surgery.

Dataset Information

Medicolegal Consideration to Prevent Medical Malpractice Regarding Opioid Administration: An Analysis of Judicial Opinion in South Korea.

Publications

Medicolegal Consideration to Prevent Medical Malpractice Regarding Opioid Administration: An Analysis of Judicial Opinion in South Korea.

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