Editorial Views  |   July 2005
What’s Wrong with This Label?
Author Notes
  • SUNY Upstate, Syracuse, New York, and The Cleveland Clinic, Cleveland, Ohio. ;
Article Information
Editorial Views / Patient Safety / Pediatric Anesthesia
Editorial Views   |   July 2005
What’s Wrong with This Label?
Anesthesiology 7 2005, Vol.103, 4-5. doi:
Anesthesiology 7 2005, Vol.103, 4-5. doi:
I USUALLY listen nightly to 11 min—the monologue—of the Tonight Show  while lifting weights. But on Mondays, I listen to a few more minutes of Jay, to hear “The Headlines.” Such “headlines” display newspaper clippings that usually have an ironic twist. For example, last week, the headline above the fold in the Philadelphia paper, “Pennsylvania to Cut School Aid by 80 Million,” was juxtaposed to that below the fold on the same page the same day, “Pennsylvania Governor Signs Bill to Spend 72 Million to Study Doodle Bug Disappearance.” As I read the article by Chang et al.  1 in this issue of Anesthesiology, I smiled to some of the same irony.
Dr. Chang and her colleagues have written a wonderful article giving us meaningful examples of “What’s in a label.” So why the irony? Probably more anesthesiologists will read the article than have read a “label” in the last 5 yr. I would even wager that more doctors have read their palm operating manual than a drug label. What’s wrong with current labels? Why can’t they (whoever they are—more, later) make it simple enough for humans (aka, anesthesia practitioners) to read?
Chang et al.  answer those questions, too. The outline a drug label must follow is ensconced in federal regulation. One wonders whether that regulation was ever influenced by someone who actually practices medicine, which is bad enough.
But then, we learn that the drafts of such label are written by pharmaceutical companies who aim to use (read: stay within the legal statements of) the label to market the drug. Some who have read labels might think that pharmaceutical manufacturers are trying to obfuscate information by not making the label readable. Chang et al.  state that the goal of the U.S. Food and Drug Administration (FDA) in approving and rewriting such drafts of labels is to provide the information necessary for the practitioner to use the drug for the approved indication in an effective and safe way. Nowhere do they state, or does regulation even imply, that it is to help the practitioner prescribe the drug safely or effectively—only to provide the information. It does not matter that the label is written with so many clauses that many lawyers must be involved and is printed in a font that makes it appropriate only for 18 yr olds with magnifying glasses.
We also learn that the final label involves a give-and-take negotiation between the sponsor (the pharmaceutical company) and the FDA staff—not the doctors of the company and a practicing physician group with the FDA staff overseeing the process. No, it is written, the article by Chang et al.  and practice indicate, so “safe and effective” seem to be the FDA staff complying with the standard of the regulation and the company having as few restrictions as possible for marketing.
Has the current label pattern ever been tested for facilitating care of a patient? Has it been tested to see whether it might get read and influence practice? Has it been tested against alternatives to determine which might be read more or which might make patient care safer and more effective?
If you have read this far, you probably think I am not likely to be invited by the FDA to be a consultant ever again—but now the attempt at redemption. There should be every reason for a label to be as enticing for physician education as a Glamour  cover for attracting female purchasers or as the Sports Illustrated  swimsuit issue for attracting male teenagers. The label should compel all to read it so we know more about a drug, not drive us away. And I believe it can be compelling.
Chang et al.  also detail the importance, the evolution, and the key components of the label. For those who have not peered at a label recently, they really are more informative than your dad’s label. Many of the labels that were okay only 20 yr ago, when I was first arguing for them to be written better, would never be approved today. (By the way, the ones written 20 yr ago still look the same if the indications for that drug have not changed.) Although it has been an evolving process, it has not evolved in a way that motivates the practitioner to enjoy reading labels (or to read them at all) or makes the practitioner believe that she is helping her patients be safer by reading them. Most of us consider the current label a little less enjoyable than traffic school or as attractive as thrice-reboiled canned peas. And whether I put on my internal medicine hat or my anesthesia hat, the label is still not anyplace near enjoyable, compelling, or user friendly.
The article by Chang et al.  should be a wake-up call. The information that they tell us is contained in the label for dosing, duration, side effects, and even chemistry is too important for safe use (patient safety) for it to be written by someone who does not care whether we read it. The article by Chang et al.  states that the FDA is considering changing the format of the label—the first ray of hope. Isn’t it about time to reform the label to convey all the information Chang et al.  says it conveys in a way that makes us want to read and reread it more than we want to do a crossword puzzle? I hope the FDA takes this as a challenge. Moses found it out: Writing the information is just the first step, harder still is to get it read, and most difficult is to find the information adopted. We need to research that key subject. The FDA ought to spend a few pennies of each user fee dollar they collect to study how to make the label as much a happening as the Leno monologue is to me, as broadly appealing as Finding Nemo  , as great a conveyor of information as The Daily Show  , as useful and motivating as Oprah  , and as easy to understand as a New York Times  headline.
Anesthesia has set the tone for patient safety and FDA processes before. Our organizations, with the guidance of Ellison C. “Jeep” Pierce, Jr. (Boston, Massachussetts; former president of the ASA and one of the founders of the ASA Patient Safety Foundation), built the foundation for the patient safety edifice; we and our drugs helped the Pilot Drug Unit at the FDA in the 1980s prove that a 180-day approval process was possible. We in anesthesia could—no, we should—construct another floor for this building: Someone needs to step forward to make labels understandable. Labels are too important to patient safety to wait for someone else to do it. The best outcome of the article by Chang et al.  would be to motivate the FDA to use anesthesia pharmaceuticals to determine, with solid research and then regulation, how to write labels in a way that actually encourages reading and facilitates patient safety.
SUNY Upstate, Syracuse, New York, and The Cleveland Clinic, Cleveland, Ohio. ;
Chang NS, Simone AF, Schultheis LW: From the FDA: What’s in a label? A guide for the anesthesia practitioner. Anesthesiology 2005; 103:179–85Chang, NS Simone, AF Schultheis, LW