Archive for March 11th, 2008

OMNI Postings of 3/11/08

Hi folks.  Just got back.  Had to write emergency doxycycline prescriptions for Gov. Spitzer.  Anyway…
Tussionex (Tussionex Pennkinetic Extended-Release Suspension) should not be given to children under the age of 6 and not more frequently than every 12 hours.  The FDA is warning us that the drug is given not only to children who are too young, but it is being dosed incorrectly resulting in severe adverse reactions and death.  We’re yalking not only about children, but even adults and adolescents.
http://omniphysicians.com/2008/03/11/fda-dangers-of-tussionex/
This report cites a study presented at an ortho conference that young athletes with a first-time shoulder dislocation do better long-term with early arthroscopic surgery.
http://omniphysicians.com/2008/03/11/arthroscopic-surgery-soon-after-1st-time-shoulder-dislocation/
Don’t bother to click on this but when I saw the “lead:”  ‘FDA Names Woodcock to Direct Drug Center,’  my first reaction was , “What the hell has the FDA to do with Gov. Eliot Spitzer?”  Only kidding.
http://omniphysicians.com/2008/03/11/fda-names-woodcock-to-direct-drug-center/
This reports on a study published in the Archives of Neurology.  Patients with ischemic stroke taking antiplatelet drugs (aspirin, persantine, and/or plavix) before thrombolysis with tPA had better functional outcomes but were at a greater risk for hemorrhage.  Damned if you do, damned if you don’t.
http://omniphysicians.com/2008/03/11/antiplatelet-drugs-with-tpa-treated-strokes-double-edged-sword/
This is a great study (said with a touch of bemused irony) from the Archives of Internal Medicine.  It seems that the rush to get antibiotics as early as possible into  “pneumonia” patients so as not to incur the wrath of the God of Quality Assurance has allowed doctors  to overdiagnose pneumonia and begin antibiotics inappropriately.  No wonder patients have more cases of the  “trots”  than pale-faced American turistas in Cancun.
http://omniphysicians.com/2008/03/11/push-to-treat-pneumonia-early-may-lead-to-misdiagnosis/
 

Arthroscopic surgery soon after 1st-time shoulder dislocation

HealthDay, 3/10/08:  Arthroscopic surgery for first-time shoulder dislocation provides long-term benefits for young, athletic patients, according to a U.S. study.

“In young, active patients, there were statistics as high as 92 percent that they would dislocate their shoulder again when conservative approaches like rest and immobilization in a sling were used,” Dr. Robert A. Arciero, of the Keller Army Hospital in West Point, N.Y., said in a prepared statement. “If we had an operation with a 90 percent failure rate, we would abandon the procedure. My thought was, why should we embrace a treatment with such a high failure rate?”

In 1993, he began doing arthroscopic surgery on young military cadets who’d suffered their first shoulder dislocation. During the 11.7 years of follow-up, the 39 study participants self-assessed the function of the affected shoulder and also underwent physical testing.

The study found that patients maintained excellent use of the affected shoulder and, on average, reported shoulder function was 93 percent of its pre-injury level of function. The participants’ average number of push ups performed in two minutes was 72.8, compared to 77.7 prior to shoulder dislocation, and the mean score on the Army Physical Fitness Test was 282.2 out of a possible 300.

Five of the patients suffered a total of eight further shoulder dislocations (all during athletic activity), which works out to a long-term failure rate of 10 percent.

“Certainly our study proves that for this group of patients — young, athletic cadets unable to modify their activity level — arthroscopic surgery for first-time dislocations is successful both short and long-term,” Major Dr. Brett Owens, of William Beaumont Army Medical Center in El Paso, Texas, said in a prepared statement.

“This treatment allowed our patients to return to sports, graduate from the military academy, and engage in active duty military obligations. It may not be the approach that should be taken for a person who lives a sedentary lifestyle, but this could be applicable to the young, 15- to 25-year-old athlete who is at high risk for recurrent instability and compromised function,” Owens said.

The study was presented Saturday at the American Orthopaedic Society for Sports Medicine Specialty Day, in San Francisco.

Antiplatelet drugs with tPA-treated strokes: double-edged sword

MedPage Today, 3/10/08:  Ischemic stroke patients taking antiplatelet drugs before thrombolysis with tPA had better functional outcomes but were at a greater risk for hemorrhage, according to a prospective observational cohort study.

In the single-center study, use of aspirin and other antiplatelet medications pre-stroke was associated with nearly a six-fold greater chance of symptomatic intracerebral hemorrhage after the ischemic attack (OR 5.6, 95% CI 2.01 to 17.11), Maarten Uyttenboogaart, M.D., of University Medical Center Groningen, and colleagues reported online in Archives of Neurology

However, patients taking the drugs were twice as likely to have a favorable functional outcome at three months (OR 2.01, 95% CI 1.03 to 4.26). This was indicated by a score of 2 or lower on the Rankin Scale, after adjusting for age, neurological deficit, systolic blood pressure, diabetes, history of hypertension, occurrence of symptomatic intracerebral hemorrhage, and presence of early ischemic changes. 

 

“Despite a higher incidence of [symptomatic intracerebral hemorrhage],” the researchers said, “the net benefit of intravenous tissue plasminogen activator therapy for acute ischemic stroke was greater in patients using [antiplatelet] drugs.” 

 

According to American Heart Association guidelines, antiplatelet therapy is not a contraindication to tPA treatment, but starting on the medications within 24 hours after receiving the thrombolytic agent is discouraged. 

 

To explore the interactions between the two treatments further, Dr. Uyttenboogaart and colleagues recruited 301 consecutive ischemic stroke patients receiving tPA up to 4.5 hours after stroke onset at the University Medical Center Groningen from April 1, 2002 through Nov. 30, 2006. 

 

All patients underwent brain CT scans, blood investigations, and electrocardiography before tPA treatment. 

 

Neurological deficit was measured with the National Institutes of Health Stroke Scale. Functional outcome was assessed at three months using the modified Rankin Scale. 

 

Nearly a third (29.6%) of the patients had taken antiplatelet drugs at some point before their stroke. Compared with patients without prior antiplatelet therapy, they were significantly older (mean age 73 versus 66, P<0.001) and more likely to have vascular risk factors, including hypertension (P=0.002), diabetes (P=0.01), and hyperlipidemia (P<0.001). They were also more likely to have suffered a previous stroke or transient ischemic attack (46.1% versus 5.2%, P<0.001). 

 

The antiplatelet drugs used were aspirin (73%), a combination of aspirin and dipyridamole (24.7%), dipyridamole monotherapy (1.1%), and clopidogrel bisulfate monotherapy (1.1%). 

 

In patients with prior antiplatelet therapy, 12 (13.5%) developed symptomatic intracerebral hemorrhage. 

 

In patients who had not previously been taking antiplatelet medications, six (2.8%) developed symptomatic intracerebral hemorrhage. The difference between the two groups was significant at P=0.003. 

 

When looking at the subgroup of patients who received tPA treatment within three hours of stroke onset, there were nine symptomatic intracerebral hemorrhages in 60 (15%) patients with prior antiplatelet therapy compared with three in 128 (2.3%) patients without previous use of the medications (P=0.002). 

 

There was no significant difference in the occurrence of symptomatic intracerebral hemorrhage in the subgroup of patients receiving tPA treatment from three to 4.5 hours after symptom onset. 

 

The researchers said that use of antiplatelet medications may increase the risk of symptomatic intracerebral hemorrhage by impairing platelet aggregation, although results from previous studies of the association have been mixed. 

 

“The discrepancies between some of these previous studies and our study may be explained by different dosages of [antiplatelet] drugs or the use of [antiplatelet] drugs other than aspirin,” they said. 

 

To explain the finding of more favorable outcomes among patients with prior antiplatelet therapy, the researchers suggested a mechanism involving the length of drug activity. “A possible mechanism behind this beneficial effect is that aspirin remains biologically active for four to six days and might prevent early reocclusion after tPA treatment,” they wrote. 

 

The study was limited by the low incidence of symptomatic intracerebral hemorrhage and the fact that the researchers did not perform routine brain CT scans after tPA treatment, the researchers said. 

 

They called for larger, prospective studies into the effect of antiplatelet therapy on outcomes after thrombolytic treatment for acute ischemic stroke. 

 

Primary source: Archives of Neurology
Source reference:
Uyttenboogaart M, et al “Safety of antiplatelet therapy prior to intravenous thrombolysis in acute ischemic stroke” Arch Neurol 2008; DOI: 10.1001/archneur.65.5.noc70077. 

Push to treat pneumonia early may lead to misdiagnosis

AMNews, 3/17/08: 

A new study says physicians are 39% more likely to misdiagnose hospital patients as having community-acquired pneumonia due to the high-stakes environment fostered by mandatory public reporting of quality measures — in this case, whether pneumonia patients got antibiotics within four hours of arriving at the hospital.

The results, published in the Feb. 25 Archives of Internal Medicine, are similar to those found in a Chest study published last year and echo many physicians’ complaints about the measure of initial antibiotic timing, known as door-to-needle time. A February 2007 Infection Control and Hospital Epidemiology study tied excessive use of antibiotics encouraged by the performance metric to a severe outbreak of Clostridium difficile at a small rural hospital.

The performance measure is part of the Joint Commission’s and the Centers for Medicare & Medicaid Services’ hospital quality reporting initiatives and was first rolled out in 2004. It represented a change from the earlier goal of getting antibiotics to hospital patients with community-acquired pneumonia within eight hours of arrival.

CMS said that beginning this month, it will not report hospitals’ results on the four-hour antibiotic timing metric and report performance on a new, six-hour goal. The change still must go through the federal rule-making process.

How performance metrics drive changes in medical practice raises a larger question, experts say, about how best to balance the benefits of public reporting against the potential for negative unintended consequences.

“The process of reducing door-to-needle time to under four hours requires major changes in how ERs function,” said Jack D. McCue, MD, co-author of the Archives study and clinical professor of medicine at the University of California, San Francisco, School of Medicine.

“When you make major changes in the way patients are handled in the ER, you have to be very careful that what you’re doing is worth it. And I think everybody’s conclusion from this adventure is that this is not worth it.”

Dr. McCue and his colleagues retrospectively examined 548 adult admissions for pneumonia at the Franklin Square Hospital Center in Baltimore for six months before the four-hour antibiotic timing metric was rolled out, and for the same six-month period a year later.

Using criteria for diagnosing pneumonia developed as part of Food and Drug Administration-directed clinical trials of antibiotics, researchers found that pneumonia misdiagnoses at admission increased 36% under the four-hour goal, while discharge misdiagnoses went up 15%.

These misdiagnoses led to a 23% increase in delays in making the correct diagnosis under the four-hour goal, researchers found.

The shift to the four-hour measure

Massive retrospective studies of pneumonia patients had supported moving to the four-hour metric. For example, a March 22, 2004, Archives of Internal Medicine study found that elderly patients with pneumonia who received antibiotics within four hours of arrival were less likely to die in the hospital or within a month after discharge. But there are no randomized controlled trials showing the effectiveness of earlier antibiotic administration.

The door-to-needle time goal is “a moving target,” said Mark L. Metersky, MD, professor of medicine in the division of pulmonary and critical care medicine at the University of Connecticut School of Medicine and a member of an expert panel for CMS’ National Pneumonia Project.

“When this first started, there were just too many patients who were not getting antibiotics until they got up on the floor, which could take six, eight or 10 hours, and that was too long, and patients were dying from it,” Dr. Metersky said. “Now that everyone is more cognizant of it and patients are getting antibiotics quicker, we have to examine these measures and make sure they’re still having benefits.”

It is better for patients with pneumonia to get antibiotics within four hours, but CMS compromised because they recognized “there may have been unintended consequences,” he said.

Dr. McCue said the change to six hours is “a weak attempt at saving face,” and the evidence is not strong enough to support the measure.

Dale W. Bratzler, DO, helped conduct much of the research showing that earlier administration of antibiotics can save lives. He said the argument that measuring door-to-needle time performance drives doctors to err on the side of a pneumonia diagnosis “makes no sense at all.”

In 2005, after the study period, changes to the measure clearly spelled out that if a physician is uncertain about a pneumonia diagnosis, that patient will be excluded from reporting, Dr. Bratzler said.

“This is a single-institution study, and it doesn’t, in my opinion, provide evidence that there’s a systematic problem across hospitals,” added Dr. Bratzler, who is medical director of the Oklahoma Foundation for Medical Quality in Oklahoma City.

FDA names Woodcock to direct drug center

 

The Wall Street Journal (3/11, B10, Mathews) reports, “The Food and Drug Administration (FDA) said former drug-center head Dr. Janet Woodcock will return to that post on a permanent basis.”  Woodcock was previously the director “of the FDA’s Center for Drug Evaluation and Research in 1994.”  She was then “appointed a deputy commissioner at the FDA, later adding the title of chief medical officer” in 2005.

FDA: Dangers of Tussionex

3/11/08: FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

Read the complete 2008 MedWatch Safety Summary, including links to the Public Health Advisory, Information for Healthcare Professionals, and the Prescribing Information at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tussionexagency verizon ringtones for mp3funny ringtones allteltreo ringtone palm 600nokia 7600 ringtonestreo mp3 ringtone 650ringtone treo 300710 ringtones mp3 verizonringtones 3g uploads Map