Department of Psychiatry and Biobehavioral Science, David Geffen School of Medicine at the University of California, Los Angeles, California, USA.
Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, California, USA.
J Eval Clin Pract. 2021 Oct;27(5):1033-1043. doi: 10.1111/jep.13566. Epub 2021 Mar 24.
Prescribed opioids are major contributors to the international public health opioid crisis. Such widespread iatrogenic harms usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system-wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future iatrogenic consequences. In this retrospective exploratory study, we report such an analysis.
The study population encompassed the entire age spectrum and included those in whom opioids prescribed for chronic pain (unrelated to malignancy) were associated with death or morbidity. Root cause analysis, incorporating recent suggestions for improvement, was used to identify possible contributory factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential.
The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were pharmaceutical, political, and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and most other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables.
The analysis suggests associations not causality.
The iatrogenic crisis has multiple intricately linked roots. The major catalyst: pervasive pharma-linked financial conflicts of interest (CoIs) involving most other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis may exemplify 'institutional corruption of pharmaceuticals'.
处方类阿片药物是国际公共卫生阿片类药物危机的主要原因。此类广泛的医源性危害通常是医疗保健组织集体决策失败的结果，而不仅仅是个别组织或专业人员的失败。对包括相关医疗保健组织在内的医源性阿片类药物危机进行系统范围安全性分析的结果可能有助于避免或减轻类似的未来医源性后果。在这项回顾性探索性研究中，我们报告了这样的分析。
研究人群涵盖了整个年龄范围，包括因慢性疼痛（与恶性肿瘤无关）而接受阿片类药物治疗的患者，这些患者的死亡或发病与阿片类药物有关。根原因分析纳入了近期改进建议，从文献中确定可能的促成因素。根据其规定的角色和预防或减轻医源性危机的潜在影响，将相关组织按最有影响力到最无影响力进行分组和分层。
分析确定了组织内和组织间存在的一系列相互关联的因果因素链。最有影响力的组织是制药、政治和药物监管组织；其次是专家及其相关学会和出版物。影响力较小的组织包括认证、专业许可和监管、学术和医疗保健资助机构。它们的观点和决策共同影响着一线医疗保健专业人员和倡导团体的处方实践。制药公司与大多数其他组织/团体之间存在普遍的财务关联。最终，患者受到了不利影响。这与心理社会变量之间存在复杂的关联。
该分析表明存在关联而不是因果关系。
医源性危机有多个错综复杂的根源。主要的催化剂是普遍存在的与制药相关的财务利益冲突（CoI），涉及大多数其他医疗保健组织。这些广泛的财务利益冲突可能是一连串错误决策和行动的触发因素，这些决策和行动对患者产生了不利影响。制药公司的行为从不道德到非法不等。医源性阿片类药物危机可能是“制药机构腐败”的一个例子。
