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CYA TMI? Drug Label Warnings List Dizzying Number Of Adverse Events

Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.

Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.

Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psychiatry (n=116), and rheumatology (n=111).

Drugs approved during the 1980s and 1990s had the highest overall number of adverse drug events, while newer medications had significantly more labeled adverse drug events than older medications.

“The findings aren’t unexpected,” wrote Dr. Duke and colleagues in the Archives of Internal Medicine. Newer drugs face more rigorous clinical trials and postmarketing surveillance than older medications. More commonly prescribed drugs are more likely to generate more reports of adverse events. The high volume of events in neuropsychiatric medications “may relate as much to patient population as to the effects of the drugs themselves.”

But, Dr. Duke and colleagues concluded, “The presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”

While the Food and Drug Administration tried to revamp warning labels in 2006, labels have grown more complex since then. “This finding underscores the tremendous challenge faced by the FDA in reversing the long-standing trend toward overwarning.”

*This blog post was originally published at ACP Internist*

Physicians Who Exercise Are More Likely To Encourage Patients To Follow Suit

Active, healthy medical students are more likely to prescribe physical activity to patients, according to research presented at a meeting of the American College of Sports Medicine.

A research team assessed objective markers of cardiometabolic health, including cardiorespiratory fitness and attitudes on physical activity counseling, in 577 freshman medical students in Colombia from 2005 to 2010. Students’ health and fitness were measured by waist circumference, body mass index, fasting glucose levels and lipid profiles, in addition to the 20-meter shuttle run test.

Attitudes toward physical activity counseling were gauged through students’ answers to “How relevant do you think it will be in your future medical practice to counsel your patients on physical activity?” and “I will have the ability to counsel my patients more credibly and effectively if I am physically active.” Read more »

*This blog post was originally published at ACP Internist*

Evidence That Doctors Make Bad Patients?

Physicians recommend treatments with higher survival rates for their patients, but they make more mental mistakes when they are the patient and have to choose for themselves.

Psychologists know that when people make decisions for others, they are dispassionate enough to be less swayed by extraneous factors. Even toddlers make less impulsive decisions for others than they do for themselves.

Researchers surveyed general internists and family medicine specialists about two scenarios, each with two treatment alternatives. Both outcomes involved a choice between surviving a fatal illness but with sometimes crippling outcomes. Physicians were randomized to groups in which they imagined themselves as the patient facing the decision, or in which they were recommending an option to a patient. Read more »

*This blog post was originally published at ACP Internist*

Does Communicating With Patients Take Too Much Time?

I recently participated in a Twitter Chat about physician-patient communications. A common refrain from some of the providers in the group was that “there isn’t enough time” during the typical office visit for physicians to worry about communicating effectively. What’s up with that?

The goal of patient-centered communications is to engage the patient in their own health care. While most physicians endorse the concept of patient centered communications, many seem reluctant to employ such techniques in their own practice.  Why?  I suspect that many fear that too much patient involvement will increase the length of the visit.

Take the patient’s opening statement aka “patient agenda” in patient centered lingo.  This is where the doctor asks the patient why they are there.  The resulting patient narrative is an opportunity for the physician to obtain valuable information to help assess the patient.  Patient centered advocates recommend that physicians use open-ended questions like “what brings you in today” to solicit the patient’s concerns and agenda.  Active listening by the physician and paying attention to the patient’s emotional cues are also hallmarks of patient centered communications.

The reality is that regardless of how they are asked, patients are often not able to complete their opening statement.   Read more »

*This blog post was originally published at Mind The Gap*

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