What is the primary role of the ACR Drugs and Contrast Committee?
Our primary goal is to optimize the safe and effective use of contrast media for the betterment of patient care. Our major charge is to draft the ACR Manual on Contrast Media, which is now in version 10.3. Essentially, the manual summarizes the safe and effective use of contrast media for CT, MRI, ultrasound, fluoroscopy and other imaging. The manual provides a consensus of scientific evidence and clinical experience concerning the use of contrast media in daily practice. The committee also stays abreast of new research and changes in safety guidelines so the manual may be updated and communication can be delivered to the ACR membership.
Many practices around the world refer to the manual when drafting their own local policies and practices, and it is one of the most referenced documents produced by the ACR. It is written in a practical style that helps people take the information it contains and put it into daily use. Every radiology practice deals with contrast media, and hundreds of millions of patients across the world receive contrast-enhanced imaging every year, so we consider the work we do to be necessary and important.
What new resources are available for radiology practices to advance quality and safety when using contrast media?
We recently published a new portable ACR Contrast Reaction Treatment Card, which summarizes important steps to be taken when managing an acute reaction to contrast material. The cards were championed by one of our committee members — Carolyn Wang, MD, a radiologist at the University of Washington. Severe contrast reactions are rare and stressful events, and radiologists might forget necessary treatment algorithms in the heat of the moment.
Having quick access to a handy card with standardized and systematized instructions will be invaluable for patient care. Now, any site that wants to provide a contrast reaction treatment card for its radiologists, nurses and technologists can simply go to the ACR website, download it, and customize it for use in their practice. We also have a pediatric version of the card that is in development. Watch this quality and safety newsletter for information about when the pediatric card will be available.
Why is the work that the committee is doing more important than ever before, especially in terms of quality and safety?
In the last 10 years, we have experienced major shifts in perception regarding the safe use of contrast media. Some side effects we used to think of as common and dangerous have proven not to be or have been effectively eliminated through changes in protocol. Other effects of contrast media are only recently gaining attention. Even though contrast media have been available for decades, we continue to learn more about their safety profiles and nuances.
What's happening with gadolinium-based contrast media (GBCM) and new requirements for FDA warning labels?
This is a rapidly evolving and incompletely understood topic, so the committee released official information about it. In brief, we now know that when patients are administered GBCM, a tiny fraction of the contrast material is retained in people's bodies for a long period of time. At this point, the safety implications are unknown, but there’s currently no scientific evidence of harm.
In September 2017, the FDA Medical Imaging Drug Advisory Committee concluded that while there was no scientific evidence of harm, further research is needed and that gadolinium retention characteristics should be considered in agent selection in vulnerable populations such as pregnant patients, children, patients who may receive many cumulative lifetime doses and patients with inflammatory conditions. FDA also recommended that radiology practices provide to outpatients receiving GBCM a standard handout developed collaboratively between FDA and drug manufacturers that summarizes the potential risks of contrast material administration.
In February 2018, a group of experts from across the world met at the National Institutes of Health to develop a gadolinium retention research roadmap to help guide future research efforts. It is expected that a publication summarizing that roadmap will be released in late 2018.
What should radiology practices to do prepare for this FDA request to give patients handouts?
I recommend that radiology practices familiarize themselves with FDA guidance and recommendations on this topic. The committee and FDA recognize the logistical difficulties in complying with the recommendation for handouts, and there is the potential for unanticipated harm (e.g., patients declining needed scans due to uncertainty about the handout contents) that will need to be monitored. FDA notes that at the current time, the risk-benefit profile for all available contrast agents in the U.S. is very favorable, and necessary contrast-enhanced scans should not be deferred solely for fear of gadolinium retention.
What advice do you have for your fellow radiologists regarding the safe and effective use of contrast media?
The ACR Manual on Contrast Media is my first-line resource for contrast media-related matters. The European Society of Uroradiology (ESUR) also produces an excellent resource, though there are some differences between the two. I recommend having at least one person in each practice be familiar with the latest contrast media developments, so they can share those updates with their partners. Our committee is working hard to make it easier for practices to make informed and consistent decisions based on best available evidence. At the end of the day, our objective is to optimize patient care, both by mitigating side effects and by optimizing diagnoses.