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Pharmacovigilance

Case Intake – Key Considerations and Pitfalls that you Want to Avoid (Part 3)

CATEGORY
Pharmacovigilance

DATE
March 9, 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 the Duplication Check and Prioritization of cases. In this blog we take a closer look at Translation and Medical Coding steps in more detail and the functionality required to ensure accuracy.

Translation

As we know, organizations receive many non-English cases and  the volume of non-English cases are growing as well. It is therefore important to have a tool that can translate automatically. The historical process has always had human translation whether by leveraging translation servers or doing it through local affiliates. Today, vendors are integrating their systems with translation tools that are available on the market or leveraging those built in-house. These translation tools can translate to English from almost any language that is spoken. It is imperative that the translation tool you select can translate to the languages that are most common or prevalent within your business.

After the case has been translated, the system should present you with both the English and non-English values so you can confirm the translation (when needed) and all employees in your offices around the world can look at the case. There should also be appropriate scoring as to how confident the system is with the translation. If it had difficulty translating the text it should identify the fields or the sections that need your attention.

Having this automated translation is one of the most cost-effective areas that these systems are providing. The translations aren’t always 100% accurate and medical terminology can be challenging for these tools, however we’re seeing an increase in performance with them within the industry.

Medical Coding

After the system has extracted all the data and done all the other steps, you want the system to be able to code to MedDRA or WHODrug dictionaries or any other dictionaries which are relevant for your system. Having the system identify, translate, and code these terms from the reported term to the medical term is going to be extremely important as well as allow you to have that consistency that we are all looking for from the system.

The system automatically coding the case is one part of this step. The other part is having the capability to properly assign the code to the appropriate field. Is it an adverse event, is it a medical history, is it a suspect or concomitant medication.

You would think that this would be one of the challenges that these tools would have, however, that is not the case. If they see something as simple as a rash, they determine how the term rash is being used within the narrative or other non-structured field and surprisingly these systems do a very good job using Artificial Intelligence and Machine Learning. They’re looking at the context around the terminology and by doing so, they’re able to place these fields appropriately. At times, there still requires some human review from a dictionary or coding perspective. We also want to ensure that the system can utilize your IME as well as the DME and any other list that you have to help derive your seriousness or other assessment values for your case.

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 t

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