There was an interesting article in the October 2014 issue of Pharmacy Practice News called A Life Preserver for the Flood of Boxed Warnings, which discussed research conducted by Christine M. Cheng, PharmD from First DataBank, Inc. (FDB) (JAMA Intern Med 2014 Aug 15), about the increase in FDA Boxed Warnings since 1996. She found that out of 522 novel therapeutics, about one third were affected by a boxed warning, with many of them being implemented after the drug reached market. The research noted that the median time from approval to first post-market boxed warning was 4.2 years.

Along with the more serious implication of boxed warnings, there are even more frequent side effect additions to drug labels that are announced every month via the FDA’s website. A quick count from August’s release shows 32 different updates. Wow! Some of the changes are minor. However, some are serious enough where it should change prescribing behavior.


Related Read: Chantix: Why the Black Box Warning Should Remain


How can busy pharmacists or prescribers possibly keep up with everything, and more importantly how can they quickly single out the ones that are important and put the alerts into context?

Unfortunately it seems as though they can’t.

Dr. Chen was quoted in the Pharmacy Practice News article as saying,

I can speak from my experience in patient care, drug information and drug policy: Managing boxed warnings is challenging, [They’ve] been around for decades, but given that there is no official repository for these warnings, and [their] passive nature—present as part of the drug label—they can be hard to keep track of and are even missed. Often, hospitals and clinicians are just looking at the high-profile ones.

Matthew Grissinger, RPh, FASCP, the director of error reporting programs at the Institute for Safe Medication Practices was quoted in the article as well:

You are always going to find out more about a drug five years after it was on the market than when it was approved, just because of the sheer number of people prescribed the medication. As a pharmacist, you have to be proactive, but it’s tough for me to remember to stop everything to look at the FDA’s website once a week [to find out about the label changes]. It is one thing for pharmacists to know, but what about the people writing the orders?

Best practice would dictate that every institution dedicate pharmacist time to digging through each of the changes, make a judgment call as to which ones are most important, and then provide a comparative analysis to other alternative drugs utilizing both clinical trial data, FDA communications, and post-marketing adverse event reports.


Related Read: Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory


The unfortunate fact however, is that most institutions simply A) do not have the resources to dedicate time to this endeavor and B) do not have the appropriate data at their disposal to be able to make the proper comparisons.

That is where data, analytics, and software come into play, coupled with expert knowledge and insight.

FDB is doing great work to integrate boxed warning information into electronic health records so it is accessible at the point of care. This is a fantastic start, but it doesn’t solve the issue of filtering out the noise, and doesn’t provide a statistically comparable way to evaluate the risks vs. alternative medications.

Through AdverseEvents Explorer’s Drug Safety Monitor, clients have access to proprietary insight from a team of highly trained analysts that comb through all of the label changes, summarize them by importance, and then provide insight and context around the ones that could potentially impact clinical behavior. You can see an example of one here.

In addition to written insight, AdverseEvents Explorer clients have access to a first of its kind predictive algorithm, RxSignal®, identifies side effects that are likely to be the subject of a future FDA action, before there is a label change or a boxed warning. This type of proactive alerting can allow pharmacy departments to stay ahead of safety concerns and better communicate to prescribers the true safety profile of a drug.

To see more Drug Safety Monitor insights and experience first-hand the power of RxSignal, sign up for a free trial.


Drug Safety Monitor Report - Viekira Pak Hepatitis C  

Jim Davis

Jim Davis

Executive Vice President

Jim Davis LinkedinJim Davis Twitter


Topics: Evidex

Jim Davis

Written by Jim Davis

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