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PP01-03: A Socio-Technical Approach to Improve Patient Safety Evaluation and Action Across the Healthcare Ecosystem

Poster Presenter

Danielle Abatemarco

Associate Director, PV Strategy, Planning and Execution
BeiGene USA, Inc.
United States

Objectives

Through partnership between a pharmaceutical company and human factors center within a healthcare system, we aim to create a holistic approach to managing patient safety. This will reduce burden, improve quality of safety reports, and enhance clinical decision making.

Method

A socio-technical systems model informed this qualitative study which involved stakeholder interviews & process mapping for AE identification, reporting, analysis and action within a healthcare system and pharmaceutical company to identify mutually beneficial opportunities for improvement.

Results

The socio-technical[1] systems model includes consideration for people, tasks, tools and technology, and the organization; this informed SME interviews within the healthcare system (eg, clinicals, patient safety officers) and the pharmaceutical company (eg, AE case processors, medical reviewers) . Interview data were used to construct process maps for both organizations which included the socio-technical system factors affecting these processes. Within the healthcare system: 1) people-many clinicians did not have clear knowledge of what should be reported and did not have time to report; further, there is an assumption this task will be completed by someone else 2) tasks/technology-the task of reporting requires several pieces of information and the reporting software does not facilitate this task; further, the information required often resides in another independent system (eg, electronic health record), both resulting in burden on the clinician 3) organization-there are no clear policies in place to guide the specific processes for reporting. Likewise, within the pharmaceutical company: 1)information-fragmented and variable in quality 2)task- time pressure to complete cumbersome tasks including evaluation & communication 3)technology-fragmented and dated 3)people/organization-informal knowledge network based on human ware. This analysis demonstrated parallels in safety data collection, collation, evaluation, communication and action with the following opportunities: 1) improve reporting mechanisms to enrich data at the point of reporting and within the HCP workflow 2) engage with patient safety officers to reduce follow-up burden on HCPs 3) tap into health system data to support product safety signal evaluation in context with the broader population 4) share scientific evidence and knowledge to inform clinical decision making at the point of care.

Conclusion

It is well documented that adverse events are under-reported and/or of low quality for a variety of reasons including lack of HCP awareness of the safety event reporting system, confusion around who is responsible for reporting (physician vs. nurse vs. patient safety officer), lack of widespread education on the importance of these data and lack of time to voluntarily report events, commonly associated with HCP burden [2]. While there is some evidence showing the benefit of initiatives aimed at educating on the importance of pharmacovigilance, there is no evidence of improved safety data quality through improved channels of engagement across the pharmaceutical and healthcare settings. The socio-technical model describes multiple factors within a system that must be considered for effective safety process to exist (people, tasks/technology, organization). Leveraging this model as a theoretical foundation, this study has yielded an initial roadmap of opportunities to improve adverse event reporting. This roadmap also serves as a plan for strategic collaboration which can affect medical evaluation, product benefit-risk characterization, scientific evidence generation and communication. Future work will include experimentation of solutions targeted to address the specific socio-technical factors identified to improve safety data collection. The authors see this work as the beginning of a paradigm shift toward integrated pharmacovigilance to improve patient safety. This includes the way in which a pharmaceutical company receives high quality adverse event reports and evaluates and communicates safety signals, which in turn benefits healthcare systems with near real-time product safety and medical information to support clinicians’ decision making. References: 1.Sittig DF, Singh H. A new sociotechnical model for studying health information technology in complex adaptive healthcare systems.doi:10.1136/qshc.2010 2. Gong Y, Kang H, Wu X, Hua L. doi:10.4338/ACI-2016-02-R-00