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Adverse Event Reporting: What Is It?

Posted on December 3, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manager doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst, a role he recently repeated for a Council member.

Eric Duncan’s Ebola death in Dallas was, to say the least, an adverse event (AE). Famously now, when he had a high fever, pronounced pain, etc., he went to Texas Health’s Presbyterian Hospital’s ER, and was sent home with antibiotics. Three days later much worse, he came back by ambulance.

In the aftermath of Duncan’s death, the hospital’s EHR, EPIC, came in for blame, though it was later cleared. Many questions have come from Duncan’s death including how our medical system handles such problems. Articles often use the term adverse event, but rarely mention reporting. I think it’s important to take a direct look at our adverse event reporting systems and where EHR and AEs are headed. This blog post looks at AE systems. The next will look at where EHRs fit in.

The FDA: Ground Zero for Adverse Event Reports

HHS’ Food and Drug Administration has prime, but not exclusive, jurisdiction over adverse reports breaking them into three classes:

  • Medicines
  • Medical Devices, and
  • Vaccines.

Four FDA systems cover these classes:

  • FAERS. This is FDA’s system for drug related adverse reports. It collects information for FDA’s post marketing for drug and biologic product surveillance. For example, if there’s a problem with Prozac, it’s reported here.
  • MAUDE. The Manufacturer and User Facility Device Experience reporting system. If an X-Ray machine malfunctions or lab equipment operates defectively, this is where the report goes.
  • VAERS. Vaccine adverse reports are collected here.
  • MEDSUN. This is voluntary, device reporting system gathers more detailed information than MAUD. It’s run by as a collaboration of the FDA and several hundred hospitals, clinics, etc. (Disclosure: My wife was MAUD project system developer.) MEDSUN captures details and incidents, such as close calls or events that may have had a potential for harm, but did not cause any. MEDSUN has two subsystems, HeartNet, which is for electrophysiology labs and KidNet for neonatal and pediatric ICUs.

MEDSUN Reporting Poster

State Adverse Event Reporting Systems

Several states require Adverse Event reporting in addition to FDA reports. Twenty-seven states and DC require Adverse Event reports, with varying coverage and reporting requirements. Some states, such as Pennsylvania, have an extensive, public system for reporting and analysis.

Patient Safety Organizations

Added to federal and state organizations are many patient safety organizations (PSOs) with an Adverse Event interest. Some are regional or state groups. Others, are national non profits, such as the ECR Institute.

The Safety Reporting Paradox

If you delve into an Adverse Event reporting systems, you’ll quickly see some institutions are more present than others. That doesn’t necessarily mean they are prone to bad events. In fact, these may be the most safety conscious who report more of their events than others. Moreover, high reporters often have policies that encourage AE reporting to find systemic problems without punitive consequences.

Many safety prevention systems work this way. Those in charge recognize it’s important to get all the facts out. They realize adopting a punitive approach drives behavior underground.

For example, the FAA has learned this the hard way. Recently on vacation, I met two air traffic controllers who contrasted the last Bush administration’s approach to now. Under Bush’s FAA errors were subject to public shaming. The result was that many systemic problems were hidden. Now, the FAA encourages reporting and separates individual behavior. The result is that incidents are more reported and more analyzed. If individual behavior is culpable, it’s addressed as needed.

In the next part, I’ll look at how EHRs fit into the current system and the congressional efforts to exempt them from reporting AEs, a move that I think is akin to putting pennies in a fuse box.

Study: Drug Problems Most Common EMR Safety Event

Posted on December 13, 2012 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

When the phrase “EMR problems” comes to mind, most of us get a  mental image of hardware flaws, software bugs or integration problems. But according to a new study, the majority of EMR-related patient care problems stem from issues in how people interact with their system, specifically in documenting and administering medication.

In recent research, the Pennsylvania Patient Safety Authority queried the state’s patient safety reporting database to identify EMR-related events. After sifting out events that didn’t truly appear to be EMR-related, analysts were left with 3,099 patient safety issue reports. The events were then classified by the harm score assigned by the reporter.

As it turns out, the great majority of events (89%) resulted in no harm to the patient. Ten percent of events were reported as “unsafe conditions” but also resulted in no harm to the patient.  Fifteen events actually resulted in temporary harm to the patient:

* Six cases of entering wrong medication data
* Three cases of administering the wrong medication
* Two cases of ignoring a documented allergy
* Two cases of failure to enter lab tests
* Two cases of failure to document

The only event that resulted in significant harm stemmed from failure to properly document an allergy, analysts said:

Patient with documented allergy to penicillin received ampicillin and went into shock, possible [sic] due to anaphylaxis. Allergy written on some order sheets and “soft” coded into Meditech but never linked to pharmacy drug dictionary.

All told, medication errors were the most commonly reported event (81 percent), largely wrong-drug, dose, time patient or route errors (50 percent) or omitted dose (10 percent).

It’s worthy of note that according to the researchers, the narrative reports of EMR-related reports dug up from the Pennsylvania database differed meaningfully from reports found in FDA database MAUDE and Australia’s Advanced Incident Management System, which have different reporting requirements.

It seems that there’s a lot more work to be done in exposing the types of patient safety errors that may be unique to EMRs, but this looks like a good start.