Spontaneous reporting is great!
- JPCC Associates
- Nov 4, 2024
- 2 min read
In the post-marketing world, the opportunity for patients or health care professionals to report potential adverse events with drugs, vaccines and devices is a simple and powerful system. When a patient, caregiver or a health care professional suspects a link between a detrimental effect and the use of a drug/vaccine/device they can “spontaneously” report it to a pharmaceutical company or health authority.
Why is spontaneous reporting so critical to patients and medication safety? It is one of the major tools allowing to confirm/revise the safety profile of products once they reach the market. The seismic shift in the volume of patient exposure compared to the clinical development phase is the only way to detect rare and serious adverse events which statistically cannot be detected before authorization. The post-marketing patient population is much broader than that in clinical trials (which have inclusion and exclusion criteria). Products may also be used off-label in patient populations/conditions that were not studied in clinical trials. The safety profile in these populations may differ.
Spontaneous reports matter very much. Even if there is often a significant underreporting of AEs, powerful modern computation and methodologies allow a good estimate close to real-life incidence, with massive databases containing millions of individual reports. The safety data is public for all to consult (though redacted for privacy) – anyone can see the most frequently reported AEs, though there is sometimes a lag regarding recent data. (see links below)
Spontaneous reporting has consequences, and it impacts public health – occasionally, products are withdrawn from the market for safety reasons, based on an accumulation of spontaneous reports and other additional investigations after potential signals are detected.
Spontaneous reporting of AEs is very important, and it benefits patients. Anyone (you) can report to either the pharmaceutical company or the regional/national health authority. The process is usually simple, and some countries have even developed phone apps for this.
Use it!
If you want to know more:
Some Health Authorities Signal Detection Links:
Access to public regulatory PV databases
Selected safety publications to monitor
Comments