Veradigm Inc.

12/02/2024 | Press release | Distributed by Public on 12/02/2024 14:45

Recent Research Demonstrates the Feasibility of Using a Digital Point of Care Solution to Facilitate and Improve Quality of Reported Adverse Event Information

Written by: Cheryl Reifsnyder, PhD and Auren Weinberg M.D., M.B.A.

In a study recently published in Therapeutic Innovation & Regulatory Science, GSK and Veradigm worked together to determine the feasibility of a compliant, bidirectional clinical communications channel between healthcare professionals (HCP) and pharmaceutical safety staff as a complement to existing pharmacovigilance methods. The tested solution provided near real-time, HCP-validated adverse event (AE) information superior to the information normally reported via traditional channels.1

In this article, we discuss the current AE reporting process, its weaknesses, and how this new research demonstrates potential ways to improve the timeliness and quality of safety information collection.

Limitations of current AE reporting

When HCPs make treatment decisions, their ability to optimize patient outcomes requires understanding both the benefits and risks of available treatment options. Currently, some of those risks are identified via post-marketing safety surveillance-primarily consisting of healthcare providers' voluntarily submitted reports of suspected AEs.

Unfortunately, these reports have a number of limitations, including:

In addition, current AE reporting is primarily a manual process, creating a significant burden for providers.

Feasibility study: Potential value of digitizing the AE reporting process

The GSK/Veradigm feasibility study was implemented using Veradigm's ambulatory Practice Fusion (PF) EHR platform, a platform primarily used by single-provider and small-group practices. Researchers selected 2 classes of drugs for the study, both of which are frequently prescribed in the primary care setting and have well-documented adverse reactions associated with them. Specifically, the study screened for the following drug/AE pairs:2

Drug Class AE
Monoclonal antibodies Serious infections
Direct Factor Xa Inhibitors Serious bleeding

A total of 1,009 HCPs consented to participate in the study.

Researchers screened for "trigger events" (the drug/AE of interest) by running automated scripts on the PF EHR every 24 hours. Once a trigger event was identified, the Veradigm Clinical Affairs team served as a trusted intermediary, facilitating the exchange of initial and customized follow-up communications between GSK pharmacovigilance experts and HCPs. No direct contact was possible between GSK pharmacovigilance experts and HCPs, thus safeguarding patient and HCP privacy. The Practice Fusion EHR secure messaging system was used for communication, with the intermediary redacting Personally Identifiable Information (PII) during each stage of communication.3

An example of the communication process and the timing of follow-up questions and responses for one of the suspected AEs is provided (Figure 1).

Study findings4

Over the study's duration, 9 drug/AE pairs of interest (AEI) were identified, 4 of which were completed interactions. Of these 4, 2 completed interactions included follow-up and 2 completed interactions indicated that the event was not an AE. The initial and customized follow-up questions with HCP responses are provided for 1 of the 2 completed HCP interactions (Figure 1).

Receipt of initial AEI information took an average of 20.6 hours; receipt of follow-up information took an average of 58.8 hours-representing a 96% time reduction compared to current AE reporting methods.

Figure 1. Example of initial and follow-up questions and responses for one of the completed interactions. FU: Follow-up, A: Answer, VCA: Veradigm Clinical Affairs, PV: Pharmacovigilance, HCP: Healthcare Provider.

In addition, both interactions provided unique data that would not have been collected using traditional reporting methods, enabling the pharmacovigilance experts to appropriately determine potential causal associations.

What's next?

The study demonstrated that it is, in fact, feasible to implement digital, bidirectional communication between HCPs and pharmacovigilance experts, providing exchange of quality AE information in near real-time. The tested solution delivered a 96% reduction in follow-up time and enabled the collection of case-specific data to aid the determination of causal association-information not typically available using traditional methods.5

However, a number of open questions still need to be addressed to fully scale and harness the potential of this solution. Specifically, it will be critical to establish best practices for its utilization to ensure patient protection.

To learn more about this study-its methods, findings, and conclusions-click here to read the complete manuscript.

About Veradigm® Real-World Evidence services

Veradigm's Real World Evidence Services serves our clients with a team of industry veterans who are well-positioned to support your research goals. Our team is experienced in harnessing real-world evidence for both retrospective and prospective studies, including safety and pharmacovigilance analyses that leverage EHR infrastructure to bring pharmacovigilance to the point of care.

References:

  1. Powell G, Kara V, Naranjo D, et al. Testing the Feasibility of a Digital Point-of-Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 2024.
  2. Powell G, Kara V, Naranjo D, et al. Testing the Feasibility of a Digital Point-of-Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 2024.
  3. Powell G, Kara V, Naranjo D, et al. Testing the Feasibility of a Digital Point-of-Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 2024.
  4. Powell G, Kara V, Naranjo D, et al. Testing the Feasibility of a Digital Point-of-Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 2024.
  5. Powell G, Kara V, Naranjo D, et al. Testing the Feasibility of a Digital Point-of-Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. 2024.