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Pharmacovigilance

Case Intake – Key Considerations and Pitfalls that you Want to Avoid (Part 2)

CATEGORY
Pharmacovigilance

DATE
March 8, 2023

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Today Pharmacovigilance has gone through what some would call a revolution. That’s due in large part to the technology that companies are implementing within their safety systems.

Many companies are assessing their case intake system. We at Astrix are assisting many companies with their projects and whether it’s helping them with their RFP’s, or with their implementations. The most common questions that we hear when assisting companies is:

  • What are the features and functionalities that we should have or expect the tool to be able to do and how’s it going to help me?
  • How is it going to make my processes more efficient?

We all know case intake is one of the most manual and time-consuming parts of the process. We at Astrix have had clients estimate that case intake is as high as 50% of the total time spent on a case.

One of the issues that companies have today, even with all the time they are spending on case intake, is that they still don’t believe they’re getting the accuracy that they desire (i.e., Inconsistencies like data missing or data not being put into the correct field). There’s a great deal of frustration with today’s process and the volume of cases that companies are getting are growing exponentially. Therefore, the workforce is extremely challenged to keep up with this increased volume. Companies are looking to invest in this area of case intake because they know there is a large return on their investment.

They are implementing intake tools that are highly automated using AI and ML automation. All the technologies that we’ve been hearing about for many years are finally coming to fruition and by using these technologies we’re seeing companies reduce the time that they’re spending on a case from what previously was 30% to 50% to maybe 20% to 0% depending on the type of case. They’re also seeing increased consistency with the data entry. For example, the AI tool they’re using is only going to spell hospitalization one way and don’t have to worry about different standards and people mistyping. They’re getting a higher degree of consistent data which is providing them with a tremendous amount of downstream efficiencies in regards to signal detection and many of the other downstream type of processes.

Companies are finding that they need less people for this part of the process by implementing these tools. This, however, doesn’t mean that they are reducing their workforce, but rather looking to reposition their employees to be more strategic and to work on other areas that really do use and require the human review or human mind. Of course, in the intake process, there’s still going to be many human interventions even with technology, however, we can also talk about a touchless situation where basically humans aren’t even looking at the case.

Now, we will discuss some of the key features that case intake systems should have and some of the pros and the cons of the systems, along with factors to be aware of when evaluating a case intake tool. We will discuss what is needed relative to the general steps of the case intake process. These case intake process steps are fairly standard although companies may have different or additional steps included or reorder them differently, however, we will discuss a general workflow that we see with clients.

The General Case Intake Process Steps

  • Data Acquisition – the company will acquire the data from some source.
  • Case Validity – next it will be checked that it’s a valid case.
  • Duplicate Check – They will see if it’s a duplicate or a follow-up.
  • Prioritization – If it’s not a duplicate, then it’s assigned a priority.
  • Translation – next it will go through a translation process for those cases that require it
  • Medical Coding – this is where the medical terminology specific to this case is added and checked.
  • Alert for Cases of Interest – if there is an alert that needs to go out for cases of special interest like a death case or a specific drug reaction combination.
  • Case Intake Review – then once all that is done the case is reviewed to ensure that all the data is entered correctly and handed off to the case processing step..

In the previous blog on this topic, we reviewed Data Acquisition and Case Validity. In this blog, we take a closer look at Duplication Check and Prioritization steps in more detail and the functionality required to ensure accuracy.

Duplicate Check

From a duplication check perspective, it’s imperative that your intake tool is looking at the data and recognizing if you’ve received this case before. The system is never going to be 100% accurate, however, the system should be capable of displaying all the cases that are potential duplicates, and most importantly, providing us with a score or probability of a match. Different systems will do it differently. Some may go from 0 to 1 or 0 to 100, with the high end representing the system is confident that it’s a duplicate.

Once we’re able to look at that case and confirm it may be a duplicate, we want to be able to display the potential duplicate case in a side-by-side view with the received case so that we can confirm that it is a duplicate or potentially a follow-up. If it is a follow-up, we want to be able to use the tool to indicate to the user what’s new, updated, or deleted.

One important point to keep in mind is that some of the vendors charge per transaction. That is whether it’s an initial case a follow up or a duplicate. Anything that’s received is a transaction, so they’ll charge you per transaction and therefore you want to try to see if there’s ways to minimize receiving duplicates or identifying them earlier in the process to help minimize this occurrence.

Prioritization

Once we have a case and we have determined it’s an initial case, we want the system to automatically assign a priority based on some automated rules. It’s extremely important for the system to be able to do this so that it pulls the user’s attention to the cases that are of the highest priority. Once we have this case list and its priority, we also want systems that are able to sort multiple columns within that case list.  In many of the systems today, you can only sort on a single column.  The ability to sort on multiple columns is extremely useful. The ability to have the system assign priority to a case will help draw their attention and work on the cases that need their consideration.

Summary

It is critically important, when looking to incorporate new technology into your business, that you ensure you have the right external organizations involved who can assist you. Formulating the appropriate strategy along with the proper processes, and technology is imperative. Astrix’s team of professionals have worked with many of the top life science organizations to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

About Astrix

Astrix  is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world-class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

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