Let's Get SMART On Adverse Events

Accurate reporting of adverse events is crucial to ensure the safety and effectiveness of drugs and treatments. Adverse events, defined by the National Cancer Institute as undesired effects that can range from mild to life-threatening, have historically played a major role in the withdrawal of popular drugs from the market. Instances of underreported adverse events have led to significant consequences, including financial losses for pharmaceutical companies, and have affected the well-being of patients.

A study has identified five core reasons behind the underreporting of adverse events in clinical trials. However, technology can provide a solution to these challenges. The SMART on FHIR framework, recently supported by a White House Office of Science and Technology initiative, is designed to simplify data entry for health professionals. This offers a solution to the heavy workload associated with adverse event reporting. The potential of an automated adverse event reporting framework supported by the White House is a step towards a future where seamless health data sharing can prevent drug failures and ensure the development of safer medicines.

Read on to learn more about adverse event reporting, the five core reasons behind underreporting, and the technologies and actions that are tackling these issues.