The ever-expanding field of pharmacovigilance highlights the importance of identifying and tackling problems with real-world safety reporting. Despite this drive to improve healthcare, overtaxed healthcare providers face a current real-world safety reporting process that is too burdensome.
For example, researchers reviewed 29 studies and identified four priorities to correct underreporting of adverse events (AES):
- Understanding and reducing barriers
- Improving perceptions of adverse event reporting within healthcare hierarchies
- Improving organizational culture
- Improving outcomes measurement
A growing body of evidence exists on documenting low rates of case reporting for AEs, and some estimates suggest that over 95% go unreported. A U.S. Food and Drug Administration (FDA) report estimates that only one in 10 AEs are reported. What limited reporting takes place is often plagued by incomplete documentation and long follow-up times.
At the International Conference for Pharmacoepidemiology (ICPE) in August 2022, researchers presented a survey of 100 spontaneous adverse event reports and found significant variation in the thoroughness of those reports across domains but particularly around prior infection history or the presence of immunodeficiency. These are readily available elements in a patient’s electronic health record (EHR).
Identifying and reporting an AE isn’t always straightforward
Reporting of any type, safety or otherwise, often occurs outside the patient encounter or takes the physician away from a person-to-person engagement with their patient. In many cases, the information needed for AE reporting is already documented and exists within an EHR ecosystem, but physicians are still required to manually enter the information in what is typically a separate process that is unrelated to patient care.
Our question is whether technology can help reduce physician burden around these readily available fields so they can focus on collecting and reporting the remaining data elements.
For example, a physician has a patient taking a particular medication, who experiences a clinical event, in this case a known potential adverse effect. The physician must mentally connect these two seemingly unrelated events and interact with an external system to re-enter the information. From a process standpoint, many opportunities exist for the reporting trail to break down because physicians often chart patient visits well after the encounter. In an ambulatory clinical setting, physicians may have 15 minutes or less to spare to report AEs. Thus, safety competes with clinical processes and attention.
When we evaluate the barriers to vetting and reporting a potential safety event, improved technology and workflow processes offer opportunities to facilitate adjudication and reporting.
- First, can technology help connect the potential AE to the medication?
- Second, can we communicate with the physician and work through this case adjudication process?
- Throughout, can we roll out education to physicians showing them both approaches and the potential benefits of a technology-based approach?
Broadly speaking, there are two approaches for supporting physicians with the information exchange needed to help with identification and reporting:
- Unidirectional: Does it help to let physicians know something is there? Do they respond to simple prompts pointing things out?
- Bi-directional: This is an actual exchange or interaction with the provider, not just a prompt. Follow-up questions can help clarify the tie potential between exposure and event, and provide additional reference materials.
Consider a patient who complains of vomiting. For this patient, does the physician know vomiting can be one of the side effects of the medications the patient takes? Do they know the patient had both the event (vomiting) and the exposure (medication), particularly if it occurred across multiple encounters or different providers within the same practice? Can the physician see both sides of the equation easily? Can the clinical process management tool (i.e., the EHR) help fill in these gaps?
Here are three considerations for improving real-world safety reporting of AEs
- Reporting adverse events must be part of the EHR
Real-world safety reporting should avoid competing with physicians’ time with patients. Physicians, who are already too busy wrestling with workflow, may end the day with 15 notes to write and 50 tasks to complete in the EHR interface. As noted earlier, these challenges lead to a problematic situation, with only 10% to 15% of AEs reported, per FDA data. EHR technologies accelerate reporting systems for faster and more seamless data sharing. This is a great benefit for clinicians who are often charged with multiple documentation tasks and patients who depend on the timely treatment of adverse events experienced in acute care settings.
- Technology that integrates AES into physician workflows enables seamless reporting
Reporting an AE situation is a must-do task for physicians. Technology within the EHR that enables this action automatically could reduce physicians’ workload and positively affect what is asked of them with streamlined reporting and easy-to-access information.
- Cloud-based EHRs help physicians ensure timeliness and easier interaction with patients
Simple and effective reporting requires the development of specific rules to quickly identify potential AEs despite minimal information to connect and report the event. Developers can build the identification logic behind the scenes. This logic can be based on regulatory materials for established outcomes and can be implemented behind the scenes without interrupting daily EHR processes based on data and information already in the EHR system. Yet, this approach demands quick and efficient implementation, possible with a cloud-based EHR.
Simplified AE reporting helps physicians interact with patients instead of the EHR
It’s incumbent upon digital health technology companies to help support providers to identify gaps that negatively impact patient care. In this case, the care process gaps contribute to low AE reporting and high rates of incomplete reporting. Notifications must find a way to seamlessly and elegantly signal the doctor to follow up and report the AEs within instead outside of the encounter. At the same time, tools to build awareness of and educate physicians about potential AEs support this approach. Overall, the long-term goal is to simplify reporting of AEs with information positioned in the correct area of the EHR.
Effective real-world patient safety reporting incorporated into the clinical workflow as a seamless extension instead of an external, burdensome task will make it easier for healthcare providers to provide better, safer care. Using technology to de-emphasize technology during care encounters helps physicians interact with the patient instead of the EHR.
How can Veradigm Help?
Veradigm is a healthcare technology company that drives value through its unique combination of platforms, data, expertise, connectivity, and scale. The Veradigm Network features a dynamic community of solutions and partners providing advanced insights, technology, and data-driven solutions, all working together to transform healthcare insightfully.
At the heart of the Veradigm Network is a significant healthcare provider footprint. With clients nationwide using Veradigm’s clinical, financial, administrative, and revenue cycle solutions. Because Veradigm can connect bi-directionally with its healthcare provider base, the Veradigm Network offers unique bi-directional point-of-care connectivity.
This type of connectivity is of significant interest when considering technology-enabled pharmacovigilance programs because they require the efficient alignment of technology, clinical research expertise, and the user experience.
Veradigm can support your pharmacovigilance program goals with:
- Tech-enabled, point-of-care surveillance
- Custom registry development and analysis
- Retrospective analyses of existing databases
Connect with Veradigm’s experts to learn how.
Mac Bonafede, Ph.D., MPH, is Vice President of Real-World Evidence at Veradigm. He leads a team of data scientists, statisticians, and epidemiologists in real-world evidence generation.
Auren Steve Weinberg, MD, MBA, is Chief Medical Officer at Veradigm. He is a physician executive with a passion for bringing the quadruple aim to the fore.