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Automated risk management and improved regulatory compliance among opportunities offered by case collection.
The life science industry has been quick to adopt many forms of technology that improve efficiency, cut costs, and reduce errors. One pharmacovigilance process, however, remains largely manual: adverse event collection.
Software to support adverse intake is not uncommon, but collecting, inputting, and sharing data primarily requires end-user intervention. Many stakeholders need to be part of this process: Patients, healthcare providers, patient support programs (PSPs), local representatives of life science organizations, and pharmacovigilance physicians all touch an adverse event report before it’s in the hands of a government regulatory agency.
Given the growing cost and complexity of meeting adverse event reporting requirements around the world, coupled with significant increases in the number of adverse events reported annually, existing intake systems are insufficient to meet the needs of modern, multinational life sciences organizations.
Case collection systems can accommodate reports of adverse events from multiple stakeholders in multiple languages across multiple geographies. They can offer opportunities for automated risk management, reducing both the frequency of, and time devoted to, medical review correspondence. Adoption of case collection systems can help organizations keep pace with the increased volume of adverse event collection without the need for substantial changes to workflows or investments in staff.
Before discussing how case collection can complement adverse event intake, it’s important to understand what each system can do on its own.
An intake system is designed to be used by the market authorization holder (MAH), which reports all suspected adverse events to the appropriate government agency. As the MAH receives cases, the intake system processes them, converting them into a format compatible with the global safety system that’s used to store and analyze adverse event reports.
Intake systems work well for processing adverse event reports, but they have a few key drawbacks. Since they are meant to be used by a single entity—the MAH—they typically leverage a single data entry form, and they tend to be provided on a single platform, typically on-premise. This limits the extensibility of intake systems. In addition, intake systems primarily support English, with translation services available only as an add-on or through a third party.
A collection system, on the other hand, is designed for use by the physicians, consumers, and PSPs who report adverse events. As a result, these systems are meant to be hosted on web- and mobile-based platforms and allow submissions in several languages. Collection systems also support custom interfaces; for example, a PSP user can be presented with a different look and feel than a physician user. Finally, collection systems are set up to feed into intake systems or directly to safety systems.
The value of the case collection system can be seen when we consider the complexity of local processing of adverse events.
Different countries have different pharmacovigilance models, which leads to significant local variations in how data is entered, reported, and processed. If there is information missing when it is reviewed by the medical specialist, it can be a tedious and complex process to secure it as a request is sent back to the local affiliate, then to the physician, and then the patient. The mechanism is complex and largely unsuccessful. The ideal situation would be to automate the questions and ask better questions at the source of the adverse event—the patient—to increase efficiency and avoid laborious processes.
All this complexity comes with costs: passing adverse event information to several stakeholders before it reaches the safety system, processing cases in each locality, and the cost of translating outgoing queries into local language. For life sciences organizations, these additional expenses add up quickly.
The growing number of adverse events being reported is another factor to consider. Case volume has been growing by 15% on an annual basis; this rate has now accelerated driven in large part by the awareness of adverse event reporting from the coverage of the ongoing COVID-19 pandemic and a growing general awareness of pharmacovigilance processes. This amounts to an adverse event case load that roughly doubles every five years.
Providing a case collection system in multiple languages makes both translation and some offshore processing unnecessary, saving time costs and ensuring that no nuance gets lost in translation. Also, by providing a Personally Identifiable Information (PII)–free version of the source document, the system can eliminate the need for manual redaction.
There are other benefits to implementing case collection systems. Integration with safety systems cuts out the step of manually entering case information. For a tier-one life sciences organization that processes 1 million cases each year, cutting down an average of just one minute per case is the work of seven full-time equivalents annually—allowing staff to process more adverse event reports in less time. This also ensures that the safety system, the intake system, and the case collection system all have consistent data, which improves accuracy and streamlines the data reconciliation process.
Leading case collection systems can incorporate risk management into the process as well. As cases come in, artificial intelligence can flag monitored products events. This allows for immediate identification and follow-up correspondence with the physician who reported it, which is much more likely to receive a response than a written letter received weeks after the event was first reported.
The goal of any pharmacovigilance team is to improve product safety. Adopting a case collection system lets life sciences organizations process more adverse events from more stakeholders in less time, and automatically share this data with integrated safety systems. This makes it possible to identify safety issues, allowing for improved regulatory compliance, and leading to improved outcomes for patients.
Andrew Donaldson, head of pharmacovigilance and regulatory technology, IQVIA