If you are a regular reader of the RxView blog, you are a drug safety advocate. Most likely though, not everyone else in your organization is as safety focused as you, understands the magnitude of safety issues, or understands how to address those issues.

It is likely hard convincing people outside of pharmacy to implement evidence-based pharmacy decision analytics. It is probably especially hard to drive a consensus decision to prioritize drug safety when there are so many other competing priorities.

So, what is best practice when it comes to forming a consensus to mitigate adverse drug events? In this post we’ll break down five things you need to do and provide some ideas on resources to do them.

Step 1: Establish the Scope of the Issue

Pre-approval clinical trials are notoriously limited in scope and do not predict most adverse drug reactions that are observed once a drug is released and used in real-world patient populations. According to research conducted by Advera Health Analytics, adverse events that occur in the real world result in roughly 1.1 million hospitalizations a year and cause up to $27 billion in medical costs. While it is not feasible to fully eliminate side effects, they can be mitigated by making drug utilization decisions that take drug safety data into account. For example, post-marketing adverse event reporting has increased dramatically over the past decade, with approximately 1,500,000 reports now being submitted to the FDA’s Adverse Event Reporting System (FAERS) database annually.

For more fact and figures to help you establish the scope, check out Section 1 of our Client Toolkit.

Step 2: Overcome objections to using real world evidence

If you have a basic understanding of pharmacovigilance and/or have worked in managed care or health system pharmacy, you probably have heard of the FDA Adverse Event Reporting System (FAERS). You may have even submitted reports to the database via MedWatch. Undoubtedly, you have also heard objections around using FAERS data that are based on outdated “myths”.

This is not an issue you should take lightly. There are certain camps of people that really are predisposed to dismissing real world data without understanding modern reporting. You need to tackle issues such as the Weber Effect, Stimulated Reporting, and Underreporting head on.

We’ve dedicated significant resources to understanding why these objections have been sowed into common beliefs and have used data driven processes to debunk these myths. See Section 2 of our Client Toolkit for access to the Myths vs. Realities.

Step 3: Provide specific use cases for real-world adverse event evidence in your organization

Understanding where real-world side effect data fit into common workflows is essential to create a business case for a mitigation program. The best way to understand how to integrate real-world adverse event data into your workflow is by viewing peer usage case studies.

For example, Memorial Hermann uses drug adverse event analytics to improve hospital drug distribution. A major western academic medical center uses real-world adverse event data to better identify drug induced conditions in their ADR call center and with their clinical pharmacists.  Another midwestern academic health system is using real world side effect analytics in the drug monographs they are providing for P&T committees. And a midwestern prominent regional health plan is using real-world data to support prior authorization decisions.

It is important to be as specific as possible when detailing potential use cases, but also set the stage for an evolving process once the procedures are in place. 

Full case studies can be accessed in Section 3 of our Client Toolkit.

Step 4: Prove the ROI for using real world evidence

With any project it is important to quantify how it will affect your organization. Having the ability to pinpoint the costs associated with drug adverse events that have a direct impact on your organization’s bottom line is essential.

If a patient takes a drug, has a serious side effect, and ends up in the hospital, that’s an added cost to the system (the hospital, the patient, and the insurer). If millions of patients are taking that drug and a decent percentage are experiencing negative outcomes, the systemic costs can be exponential. By quantifying the risk profile of a drug and its downstream medical costs, you are able to make better decisions, optimize formularies, and provide safer drugs  options to prescribers and patients.

To estimate these potential savings, we have provided downloadable Excel ROI calculators in Section 4 of our Client Toolkit.

Step 5: Build a business case tailored to your audience

When building a business consensus for using real world adverse events data in your organization, context matters. What you present to the Chief Pharmacy Officer or VP of Pharmacy is different from what you’d present to the Chief Medical Officer, which is different than what you’d present to the Chief Financial Officer. It’s important to know what is valuable to each of your audiences.

It is Pharmacy leadership's job to ensure workflow is as efficient and fluid as possible. That means making sure that there is a complete understanding of how a new system will enhance the department, and at the same time fit into budget requirements. The first thing you need to do is to align the purchase to those goals. Some common goals that we hear are:

  1. Create processes to better manage formulary reviews that will enable the incorporation of large amounts of newly approved drugs and the huge pipeline of soon-to-be-approved drugs
  2. Reduce pharmacy drug spend through tightly managed formulary
  3. Consolidate P&T from hospital to system-wide approach
  4. Mitigate adverse events through drug information to drive the organization’s quality rating

Examples of how real world data and analytics help to meet these goals can be found in Section 5 of the Client Toolkit, along with other examples on how to get buy in from the CMO and CFO.  

Bringing it all together

Through the five steps outlined above, you now have the tools to form a consensus to mitigate adverse events at your organization.  Feel free to use the Client Toolkit that we have created to help make your case, and demonstrate to your colleagues and management how implementing evidence-based pharmacy decision analytics delivers immediate short-term and long-term value.

You can access the full Client Toolkit here.

Let us know if you think we missed anything, or other strategies that you have used within your organization to gain consensus around these issues.


Jim Davis, EVP Advera Health Analytics



Topics: Real World Evidence

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.