Department of Medicine, Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
J Gen Intern Med. 2020 Feb;35(2):538-545. doi: 10.1007/s11606-019-05490-w. Epub 2019 Nov 14.
Opioids are a leading cause of adverse drug events in the hospital. Guidelines recommend that physicians assess the risks of opioids and discuss them with patients when considering opioid use. There are no studies examining patient- and prescribing-related risk factors for opioid-related adverse drug events (ORADEs) in hospitalized medical patients.
To identify independent risk factors for severe ORADEs in hospitalized medical patients.
Retrospective cohort study.
Medical patients hospitalized at US, non-federal, and acute care facilities, with at least one pharmacy charge for an opioid during hospitalization. We excluded patients with metastatic malignancy, hospice, or palliative care billing codes.
We used Cox proportional hazards modeling to identify risk factors for severe ORADEs, defined by a pharmacy charge for naloxone. Candidate risk factors were chosen a priori, based on clinical grounds and prior literature.
Among 731,208 hospitalizations (median age 60, 56.5% female), a severe ORADE occurred in 2727 (0.4%). Independent risk factors included patient characteristics (advanced age, female gender), comorbidities (congestive heart failure, opioid abuse/dependence, non-opioid drug abuse/dependence, psychosis, depression, obstructive sleep apnea), organ failures on admission (respiratory failure, shock/hypotension, renal failure, hepatic failure, acidosis, and neurologic failure), medication co-administrations (antipsychotics and short-acting benzodiazepines), and characteristics of the opioid prescriptions themselves (total dose for the day, parenteral route of administration, and receipt of multiple types of opioids in a day). Although a risk prediction model derived from these factors performed well on stratified k-fold cross-validation (average c-statistics 0.68-0.71), the low incidence of the outcome limited the positive predictive value of the risk score.
In this national cohort of medical patients, we identified several risk factors for ORADEs that can be used to inform physician decision-making, conversations with patients about risk, and development and targeting of harm reduction strategies for at-risk populations.
阿片类药物是医院中不良药物事件的主要原因。指南建议医生在考虑使用阿片类药物时评估阿片类药物的风险，并与患者讨论这些风险。目前尚无研究探讨住院内科患者中与患者和处方相关的阿片类药物相关不良药物事件（ORADEs）的风险因素。
确定住院内科患者发生严重 ORADE 的独立风险因素。
回顾性队列研究。
在美国、非联邦和急症护理机构住院的内科患者，至少有一次在住院期间开具阿片类药物的药房费用。我们排除了患有转移性恶性肿瘤、临终关怀或姑息治疗计费代码的患者。
我们使用 Cox 比例风险模型来确定严重 ORADE 的风险因素，严重 ORADE 通过药房开具纳洛酮的费用来定义。候选风险因素是根据临床依据和先前的文献预先选择的。
在 731208 例住院治疗中（中位数年龄 60 岁，56.5%为女性），有 2727 例（0.4%）发生严重 ORADE。独立的风险因素包括患者特征（年龄较大、女性）、合并症（充血性心力衰竭、阿片类药物滥用/依赖、非阿片类药物滥用/依赖、精神病、抑郁、阻塞性睡眠呼吸暂停）、入院时的器官衰竭（呼吸衰竭、休克/低血压、肾衰竭、肝功能衰竭、酸中毒和神经功能衰竭）、药物联合治疗（抗精神病药和短效苯二氮䓬类药物）和阿片类药物处方本身的特征（每日总剂量、给药途径和一天内接受多种类型的阿片类药物）。尽管从这些因素中得出的风险预测模型在分层 k 折交叉验证中表现良好（平均 c 统计量为 0.68-0.71），但结局的低发生率限制了风险评分的阳性预测值。
在这项针对内科患者的全国性队列研究中，我们确定了 ORADE 的几个风险因素，这些因素可用于为医生决策提供信息，与患者讨论风险，并制定和针对高危人群的减少伤害策略。
