"Coffee with The Chief"
Definity® labeling change removes many barriers to use, survey suggests market was severely impacted by previous labeling
Tim Thigpen, Editor
10 June 2008
The FDA has recently granted a class labeling change to Lantheus Medical Imaging's Definity®, based on Prescribing Information revisions effectively modifying the FDA's benefit/risk assessment.
The previous labeling, initially introduced in October 2007, had a profound impact on Definity® use based on an independent survey of the community at EchoChief.com
From October 2007 just after the initial FDA "black box" warning until June 2008, we asked the community at EchoChief.com to tell us how the October 2007 labeling would impact their use of Definity®.
Just over %50 said they were "significantly reducing" while %23 said they "completely eliminated" the use of Definity®.
Most agree the new labeling strikes a better balance between patient safety and clinical needs to improve diagnostic confidence. The challenge now is to communicate to the physicians and staff about the revised labeling and what it means in practical terms to their practice patterns.
It will take a few months to gauge how quickly users come back to the use of contrast agents in general and Definity® in particular.
Much has been happening in the ultrasound contrast agent market. In case you missed it Definity® is now owned by Lantheus Medical Imaging, whose parent compnay is Avista Capital Partners.
Both Bracco (SonoVue®) and GE Healthcare (OPTISON™) hope to have their agents FDA approved with similar labeling soon.
Another company, Acusphere, has filed a NDA with the FDA for their ultrasound contrast agent (magify™). If approved Acusphere's magify™ would be the first ultrasound contrast agent approved for detection of coronary artery disease.
While we encourage you to read the entire packaging details.
You can get a quick sense of the how the "black box" labels differ between the initial October 2007 and current revison below.
April 2008 Definity® Black Box
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
•Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
•In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS).
•Always have resuscitation equipment and trained personnel readily available.
October 2007 Definity® Black Box
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY® administration.
Assess all patients for the presence of any condition that precludes DEFINITY®
administration (see CONTRAINDICATIONS).
Monitor patients during and for 30 minutes following DEFINITY® administration,
including vital sign measurements and electrocardiography in all patients and cutaneous
oxygen saturation in patients at risk for hypoxemia.
Always have resuscitation equipment and trained personnel readily available (see WARNINGS).
Guest Editorial, Ergonomics
Time for Sonographers to Take Individual Responsibility.
By
Joan P Baker MSR RDMS RDCS
We have known about occupational injury in sonography for many years now. It was in the early 1980’s that Marveen Craig brought to light the complaint of many sonographers with sonographer’s shoulder
In 1995, a survey was conducted in the US and Canada to determine the extent of injuries suffered by sonographers in the performance of their daily routine. The response was dramatic with an 81% injury rate among practicing sonographers, in the United States and 87% injury rate in Canada. In the last twelve years people from hospitals, schools and industry have joined together to combat this career threatening problem. Much has been learned in the last 12 years but we still have a long way to go. Awareness of the problem is far greater today than it was in 1995; but what is not known is whether that awareness has translated to higher or lower incidence rates.
Sound Ergonomics is repeating the survey this year including many of the questions from the 1995 survey . The results so far are alarming as well as disappointing. The incidence of scanning in pain or discomfort has increased to 87%, as reported by approximately 3000 sonographer respondents to the 2008 survey. The main site of pain and discomfort is the shoulder with the neck and wrist second and third. The age demographics of sonographers have changed with a largest percentage of respondents now over 50 compared to 12 years ago. This is proof that we are an aging work force.
Age chart showing 1995 in blue and 2008 in red
It is interesting to note that 18% of the respondents have been scanning between 16-20 years and 31% more than 21 years. Of the respondents 51% are less than 5 feet 5 inches tall. There was about an equal amount of ergonomic versus non ergonomic equipment being used in the field. The majority of respondents had height adjustable tables (78%), however, 42% of those were only manually adjustable. Our experience tells us these are probably not adjusted during scanning. When asked “would you be more inclined to adjust the table if the features were easy and quick to use” 90% of respondents said “yes”. When asked what in the respondent’s opinion the reasons are for their pain and discomfort they replied shoulder abduction, applying pressure, sustained and repetitive twisting of the neck and trunk.
All these reasons relate to sonographer technique. We MUST take responsibility for how we scan. It is not how many scans you perform but HOW you perform them that matters. You are the only person that can stop abducting your arm, applying too much pressure or twisting your neck and trunk.
Sound Ergonomics will be sharing the complete results of this survey with all those that fill it out. There is still time to contribute to the largest survey ever conducted. March 14th 2008 is the deadline to participate.
Please go to our survey.
Joan Baker is President of Sound Ergonomics, Inc .
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