In this post, we will focus on the three primary phases of Adverse Event Case Processing (AECP): intake, processing and reporting, and their related challenges. Many of the Intake process-related tasks are further exacerbated as we straddle the worlds of analog (manual) and digital (automated) processes. In this blog post, we will review the challenges associated with AECP intake.
Let’s begin with some key definitions.
black hole, defined – noun Astronomy
1: a region of space having a gravitational field so intense that no light, matter or radiation can escape.
- an empty space – void
2: a place where people or things, especially meaningful data, disappear without a trace.
An Adverse Event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of a medicinal product or device. AE’s categorized as “serious” (results in death, illness requiring hospitalization, events deemed life-threatening), must be reported to regulatory authorities immediately, whereas non-serious adverse events are documented and reported and sent to the regulatory authority.
As new drugs or medical devices enter the consumer market, their use expands geometrically beyond the confines of a controlled clinical setting. Expanded use means the potential for unforeseen reactions, which must be carefully monitored and can drive changes to (product) labeling usage. Pharmaceutical and medical device manufacturers are required to track AE’s and report them to their governing regulatory body, i.e., FDA, EMA. In the US, the FDA tracks adverse drug events (ADEs) and medication error reports through the FDA’s Adverse Event Reporting System (FAERS). This collection process begins with intake.
When an HCP or a consumer lodges a complaint, it generally comes through one of four main channels – phone, web, fax or analog post (mail). Increasingly, big data sources from healthcare payers along with conventional searches of medical literature are playing a growing role. Some drug or medical device manufacturers may also be actively monitoring social media posts, listening for product-related AEs. It is the role of the AE intake team to collect and normalize reported information.
Here’s what we heard from executives responsible for the intake-side of PV Operations.
- “(Intake) Automation” is our biggest objective. We have some tools to manage (automation) but there are many gaps.”
- “I can’t measure (Intake) performance since so many processes are done manually.”
- “We need to eliminate fax and manual data entry. Vendors provide AE forms on paper which must be manually data-entered.”
- “Our Intake is outsourced to a third-party,” “We use Outlook to collect AEs,” “Outlook is unstable, i.e., mailbox size limits, auto-purge, accidental deletion, etc., and not very secure”
- “The majority of AE’s are (inbound call-center) based. We want to move to true omni-channel intake.”
- “We want to automate Intake for high-volume, low value cases, the majority (>70%) of which are non-serious.”
- “We need better visibility to field-level diligence as many of these processes happen outside of the system.”
So how do we fix this? We fix this through automation, allowing the flow of intake to follow a more digital path. Have digital “robots” monitor intake channels for digital normalization and initial level triage. Allow systems to open and read attachments and forms, recognizing priority AEs for faster processing. Provide better visibility into process streams and throughputs so we can measure peaks and valleys, productivity and process viability. Automate upstream reporting and integration to systems like Argus and ArisGlobal.
The Safety System Singularity
Solving the automation challenge requires innovative thinking and new approaches. Conventional PV systems remain mired in monolithic architectures, and require major customization to adapt to technologies like optical character recognition, natural language processing, and semantic coding and classification. Even basic integration is a challenge for popular systems like Argus, which offer limited ability to integrate beyond the exchange of E2B files – creating a proverbial “black hole” for AE cases. This limits much needed innovation for the benefit of not only efficiency improvements but also more proactive patient safety.
Innovation is at the core of the biopharmaceutical industry, just not always at the surface. Pharmacovigilance is an area sorely in need of innovation, with reported AE volumes rising at 10-20% annually. This means that without innovation, PV operations will soon be unable to scale to meet demands. Furthermore, the valuable resources currently spent on low-value manual efforts in PV would be better applied to more effectively managing risk-benefit oversight, improving big data surveillance, and pharmacogenomics.
Escaping the Gravity of Conventional Wisdom
There is innovation in pharmacovigilance; you just need to look beyond the status quo. Companies like C3i and Agios Biopharma are asking the right questions and setting the stage for innovation. C3i manages patient services for their biopharma customers holistically, automating case intake as an integrated part of their patient engagement services. By connecting patient assistance/access, medical information, health coaching/care management, and adverse events and product complaint management, they keep the patient at the forefront, ensuring that an adverse event is understood as part of the patient experience, not something separate to be dropped into a safety system and forgotten. Being patient-centric helps keep the risk-benefit equation front-and-center.
Likewise, Agios Biopharma is augmenting advanced text analytics and natural language processing to speed and augment their abilities to detect and understand adverse events. They can rapidly convert unstructured text from an as-reported call center, social media, and literature cases to quickly identify adverse events, as well as in conjunction with MedDRA and WHODrug coding to accelerate case processing. This gives them faster, automated intake, assessment, and an understanding of adverse events, from more sources, without needing additional resources.
While C3i and Agios are solving different problems within PV, they do have one thing in common. They needed to free their data and processes from the black hole of conventional safety systems. They realized that to fully take advantage of this sort of innovation, both companies needed a more flexible, configurable, and adaptable PV platform.
The article is co-authored by Ed Chase, Pegasystems Director, Life Sciences Solutions . It was originally published on Health IT Outcomes and is re-posted here by permission.