Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study

Interesting series of messages. It should be obvious how valuable it would be to get more consistent reporting of ADRs. This is sometime I have been advocating for several decades. I understand from a meeting I was in about 10 year ago that Health Canada receives only a handful of reports a year from physicians. It should be an obvious requirement in EMRs to facilitate reporting of problems. When a physician discontinues a medication there should be a place to indicate why. If the reason is an ADR then a window could pop open with a form to fill in and then when this is completed the physician could click on a button to send the form to the appropriate site. Even though this has been presented to various organizations and groups over at least 20 years their has been no interest in developing this function. The vendors use the excuse that no one is asking for this function. Physician organizations and Infoway have not been interested in pushing for the functionality

Another problem is that if you do want to fill in the form to report an ADR it takes quite a while to work your way through all the questions. A lot of the required information is already in the EMR. To fill in one of these forms takes a lot of time that physicians just do not have.

If Health Canada is interested in receiving more reports they should develop a form that can be used in EMRs and be filled in form data that is already in the EMR. There is a lot of work going on with CDA, FHIR, HL7 working groups on templates,... that could be used as the foundation for properly designing a system that would work. Expecting physicians to take the time to fillin these forms on a voluntary basis is a big ask since we are struggling with all of the other stuff we are expected to do during an office visit. Mike Bainbridge gave a presentation to so that if a physician did all the stuff that they are expected to do during a 7 minute visit it would take 18 minutes to accomplish.

If Health Canada wants these reports they will need ot make it easy to do.

Systems like this already exist in various guises (I have experience of several across a variety of nations and in a variety of contexts - primary and secondary care). The international standards to transmit the information between systems also exist.
Terminology is one challenge, but the CCDD can address that.
The other challenge is for there to be enough incentive for vendors to implement good systems

Here is the link to Health Canada reporting -

www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html

Capturing the information itself is not an issue. The problem is more on the transmission side - no one wants to print a form and send it by fax...

Do ISMP and Health Canada publish the data structure they need for these reports? Are Web services where structured information (JSON or XML) can be sent available?

Raymond Chevalier
Vigilance Santé

Health care professionals are not reporting adverse drug events. Recently published out of BC by Dr. Hohl. See paper: publichealth.jmir.org/2018/1/e21/

They did a qualitative study in 3 acute care facilities (inpatient, ER, ambulatory clinic) in B.C. to explore why 65 adverse drug events were not reported to external agencies. Time constraints, double documentation and interference to workflow were contributors.

The conclusion: “Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.”

Well – isn’t this a great opportunity for Vendors. Perhaps the software could help push the ADEs to the most appropriate organizations for analysis (i.e. incidents / errors to ISMP Canada and adverse reactions to Health Canada).

Lisa
ISMP Canada