Aggregate safety reporting is an essential component of drug safety, enabling the identification and management of safety concerns related to a product. It is also an extremely resource intensive, complex, and never-ending exercise that requires significant coordination by various teams. Failing to deliver on these activities could have serious consequences for patients, pharmaceutical, and biotech companies. Historically, safety monitoring was a reactive process that relied on spontaneous reporting of adverse events. However, this approach is associated with delays in identifying safety concerns and managing them, which pose a significant risk to patient safety. In recent years, the approach to safety monitoring has shifted from reactive to proactive, driven by technological advancements, changes in regulatory requirements, and increased collaboration between industry stakeholders. This blog post will discuss why aggregate safety reporting was reactive in the past and how it has evolved into a more proactive approach.
Why Aggregate Reporting Was So Reactive
In the past, regulatory agencies typically relied on spontaneous reporting systems to identify potential safety issues. This reactive approach meant that safety concerns were often only addressed after the product was already on the market, which increased the risks to patients. Additionally, safety data was often incomplete, inaccurate, and difficult to analyze due to the use of paper-based systems, which made it challenging to identify potential safety issues and take action to prevent harm to patients. Furthermore, the lack of communication and collaboration between industry stakeholders meant that safety data was not shared effectively, which resulted in missed opportunities to identify and address potential safety concerns. This approach was reactive and often resulted in delays in identifying safety concerns, which posed a risk to patient safety.
The reactive nature of reporting was also associated with incomplete and inaccurate safety data. Spontaneous reporting systems relied on the voluntary reporting of adverse events, which resulted in underreporting of safety concerns. The safety data was often incomplete and difficult to analyze due to the use of paper-based systems, which made it challenging to identify potential safety issues and take action to prevent harm to patients.
The Shift Towards a Proactive Approach
The shift towards a more proactive approach to safety monitoring has been driven by several factors, including changes in regulatory requirements, and increased collaboration between industry stakeholders. However, the most profound enabler for the shift is technological advancements.
The Adoption of Electronic Reporting
One of the most significant changes that have occurred in recent years is the adoption of electronic reporting systems. Electronic systems enable more efficient and timely reporting of safety data, which enables regulatory agencies to quickly identify potential safety issues and take action to prevent harm to patients. Electronic reporting systems also provide more accurate and complete safety data, which is essential for making informed decisions about the safety of pharmaceutical products.
Increased collaboration between industry stakeholders has also contributed to the shift towards a proactive approach to safety monitoring. Relying on new technology solutions, Pharmaceutical companies and their partners, regulatory agencies, and other stakeholders are now working more closely and with more agility than ever before to identify potential safety concerns and develop strategies to prevent them. This collaboration has led to the development of new safety monitoring tools and methodologies, as well as improved communication channels between stakeholders.
The Demands of Regulatory Requirements
Regulatory requirements have also changed significantly in recent years, with many regulatory agencies requiring more extensive safety monitoring and reporting. For example, in the past decade the EMA has introduced guidelines for periodic safety update reports (PSURs) that require more comprehensive safety data and analyses. Similarly, the FDA has introduced requirements for post-marketing safety monitoring and reporting.
Improved Patient Safety
The shift towards a proactive approach to safety monitoring has resulted in improved patient safety and better-informed decision-making. The adoption of electronic reporting systems, increased collaboration between stakeholders, and changes in regulatory requirements have all contributed to this shift.
The one down-side to these advancements – increase in speed, collaboration, and evaluation – is the accompanying increase in burden on the Pharma and Biotech companies to track and manage these activities. In order to comply with these regulations and growing demands, companies must invest significant resources into tracking and managing their activities. A robust tracking solution can help companies stay on top of their regulatory requirements and streamline their operations, ultimately leading to more efficient and effective drug development. By leveraging technology and automation, companies can reduce the burden on their staff and improve their overall performance in the highly competitive pharma industry.
In recent years, there has been a notable transformation in aggregate safety reporting, shifting from a reactive stance to a proactive one. This shift is primarily attributed to significant technological advancements, evolving regulatory requirements, and enhanced cooperation among various industry stakeholders. As a result, patient safety has improved, and decision-making processes have become more informed. Given the ongoing progress of technology, it is foreseeable that the proactive approach to safety monitoring will continue to further enhancements in ensuring patient safety.
However, this positive change comes with a cost to pharmaceutical and biotech companies. They now need to track, handle, and prove that they are meeting the requirements for increased safety reporting. Companies that used to reply on manual tools and processes for scheduling and managing report generation are facing challenges in handling their reporting schedules, resources, and timelines.
Implementing a fit-for-purpose software such as Orbit for aggregate safety reporting can alleviate that burden. Orbit is designed to manage the entire reporting lifecycle, from scheduling to authoring and reviewing to managing the submission process and feedback. Orbit fully automates your reporting timelines, kicking off report workflows to eliminate missed reports and keep you compliant in perpetuity – weeks, months, and even years into the future. With automated notifications, templates, customizable workflows, and centralized data management, Orbit handles the routine activities, allowing stakeholders to focus on other critical aspects of pharmaceutical safety management.