FDA proposes revamp of conflict of interest rules

As reported in the LA Times:

The Food and Drug Administration said Wednesday that it would bar outside medical experts with a financial interest in a manufacturer from voting on advisory panels assessing whether drugs or other products made by that company are safe and effective.

The proposed restrictions — which would also apply to experts with ties to competing firms — would significantly strengthen the FDA's conflict-of-interest policy. One recent study suggests that more than one-fourth of FDA advisors may be prohibited from voting.

Click here to read the entire article (registration required).

Joint Commission Annual Report

Check out the annual report recently released by the Joint Commission. While things seem to be on the upswing, looks like there's still room for improvement in hospital quality of care:

Hospitals are currently achieving a national average of 90 percent performance or higher on only about half of the measures tracked since 2002. Hospitals are performing at less than 65 percent nationwide on two measures tracked since 2002: providing pneumococcal screening and vaccination to pneumonia patients, and providing discharge instructions to heart failure patients. The Joint Commission encourages all hospitals to strive for 100 percent performance on all measures.

On measures tracked for the first time in 2005, performance is generally lower and more variable than on the performance for measures tracked since 2002, showing a correlation between performance measurement and quality.

Significant differences exist in the performance of hospitals by state. For example, the performance of hospitals in different states on the measure of providing smoking cessation advice to heart attack patients ranged from a high of 96.8 percent performance in the highest-performing state to a low of 67.6 percent in the lowest-performing state.

CME Providers in health care delivery institutions, check out your hospital's quality performance at qualitycheck.org.

Collateral fire damage

Fascinating epi study published in the New England Journal of Medicine on firefighters and death from heart disease in the United States. One of the study findings:

Fire suppression, which represents only about 1 to 5% of firefighters' professional time each year, accounted for 32% of deaths from coronary heart disease and was associated with a risk of death from coronary heart disease that was approximately 10 to 100 times as high as the risk associated with nonemergency duties. We think that the most likely explanation for these findings is the increased cardiovascular demand of fire suppression.

Click here to read the entire free article.

Two new books by physician-writers

Health care professionals (e.g., CME professionals) might be interested in two new books authored by physicians. They are "Better: A Surgeon's Notes on Performance" by Atul Gawande and "How Doctors Think" by Jerome Groopman. From the Washington Post article:

The authors' hopes for medical practice based on greater self-scrutiny will be a tall task as well. We live in an era of evidence-based medicine, in which population-based studies, Bayesian analysis and clinical guidelines increasingly dictate medical care. Both authors bemoan this development insofar as it makes physicians into technicians. Doctors, Gawande writes, need to stop to "wonder" and reconsider the paths they have taken. Groopman's best physicians arrive at judgments by assessing not only their patients' complaints but their characters and by paying attention to their own emotional responses to patients.

Reflection is a good thing and part of the improvement process. Click here to read the entire article.

And the results are in...

JAMA just published an article on the early results of the Vermont and Minnesota laws requiring pharmaceutical companies to disclose payments to physicians:

In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years.

Click here to read the article (subscription required).

Following doctor's orders...NOT!

A recent survey by the Wall Street Journal and Harris Interactive reveals that 27% of Americans who responded do NOT fill a precription because they don't feel it is warranted. More from this interesting survey:

About 52% of Americans believe doctors overtreat patients because of concerns about malpractice lawsuits, while 41% say doctors do so "to make more money" and 44% say "to meet patients' demands."

Still, Americans seem to believe that undertreatment is a problem, too. When asked how often they believe patients are undertreated, 29% said often and 55% said sometimes.

Click here to read the WSJ article (subscription required).
:)

Errors in diagnosis

According to Dr. Jerome Groopman, misdiagnosis occurs in 15 to 20 percent of cases. Why? Because of how doctors think:

Only very recently have medical educators begun to focus squarely on the problem of misdiagnosis, why it occurs, and what might be done to prevent it. It turns out that errors in thinking do not occur in isolation, but usually arise from a cascade of sequential cognitive mistakes.

I only learned this recently when I realized I did not know how I think; in fact, when I asked other clinicians how they succeeded or failed in making a diagnosis, very few could explain how their mind works to decipher a patient's problems.

Click here to read the Boston Globe article. What implications do you think this might have for CME?

A piece of Dr. Reece's mind

Great essay by Richard Reece, M.D. published today in HealthLeaders Media. Doctor Reece discusses the complex issues that arise with pay for performance (P4P). He presents, methinks, very valid questions and truths relative to this whole issue of P4P, an excerpt:

Compelling doctors to follow guidelines and enforcing their compliance is not as easy as it might seem. Whose guidelines? Keep in mind there are more than 2,000 guidelines floating around out there. You may find them at the National Guideline Clearinghouse website (www.guideline.gov). These guidelines depend on both evidence and opinion and are neither infallible nor a substitute for clinical judgment.

Doctors are mortal and may have a hard time keeping all these guidelines in mind. Small wonder that adherence to guidelines and outcomes vary. As I outline above, patient behavior outside of the office and hospital settings is an important factor in healthcare outcomes. Doctors can’t be held solely--or even primarily--responsible for outcomes, and rewarding or punishing them for outcomes may be overly simplistic. Doing so in the confined hospital setting may make P4P advocates “feel good,” and it is a good place to start, but P4P may not lead to better long-term outcomes.

We all know those people who won't quit smoking, who won't exercise, etc., even after they've endured life-saving procedures. Click here to read this important essay (you have register).

ACCME news release

The Accreditation Council for Continuing Medical Education (ACCME) is implementing a new system to recognize non-U.S. CME accreditors:

At the ACCME, "Recognition of non-US continuing medical education accreditors" will be based on substantial equivalency of accreditors. Our engineering colleagues[1] state that "substantial equivalency means the program is comparable in educational outcomes, but may differ in format or method of delivery" and that "substantial equivalency is not accreditation."

And the question that comes to everyone's mind is "will they have to comply with the ACCME Standards for Commercial Support of CME"? Click here to read the news release in its entirety.

New label warnings for sleep disorder medications

The FDA has ordered manufacturers of 13 drugs used to either treat sleep disorders or used as sleep aids to revise their "product labeling to include warnings about the following potential adverse events":

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

The 13 drugs are:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

Click here to see the FDA news release.

"Questions Are the Answer"

The Agency for HealthCare Research and Quality has launched a new national public awareness campaign to encourage patients to become more proactive and assertive in their medical care. The idea is that if patients ask the right questions at the right time, then medical errors might be reduced. Here are a few of the questions they suggest asking:

What is the test for?
How many times have you done this?
When will I get the results?
Why do I need this surgery?
Are there any alternatives to surgery?
What are the possible complications?
Which hospital is best for my needs?
How do you spell the name of that drug?
Are there any side effects?
Will this medicine interact with medicines that I'm already taking?

Honestly, I can't get my Mom to ask any questions of her health care provider, much less these. Click here to access the general website; click here to access "20 Tips to Prevent Medical Errors."

FDA black box warning on anemia drugs

The FDA issued an advisory today on erythropoiesis-stimulating agents (ESAs) which are "approved to treat anemia in patients with chronic kidney failure, and in cancer patients whose anemia is caused by chemotherapy." From the SCIENTIFICAMERICAN.COM article:

"Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory said.

"Because all ESAs work the same way, the findings from these studies apply to all ESAs; the FDA is re-evaluating the safe use of this drug class," the advisory said.

The FDA will gather further input from a May meeting of a panel of outside experts. More changes to the drugs' labels could follow that meeting, FDA officials said.

Click here to read the entire article. CME Providers might want to review their enduring material lists!

16 Rules to live by

Thanks to Sue Pelletier, MeetingsNet Web editor, mad blogger (Face2Face), and editor of Association Meetings Magazine for including the link to Bob Parson's 16 rules to live by in her blog. The 16 rules:

1. Get and stay out of your comfort zone.
2. Never give up.
3. When you're ready to quit, you're closer than you think.
4. With regard to whatever worries you, not only accept the worst thing that could happen, but make it a point to quantify what the worst thing could be.
5. Focus on what you want to have happen.
6. Take things a day at a time.
7. Always be moving forward. Never stop investing. Never stop improving. Never stop doing something new.
8. Be quick to decide.
9. Measure everything of significance.
10. Anything that is not managed will deteriorate.
11. Pay attention to your competitors, but pay more attention to what you're doing.
12. Never let anybody push you around.
13. Never expect life to be fair.
14. Solve your own problems.
15. Don't take yourself too seriously.
16. There's always a reason to smile.

The above rules are displayed here with the permission of Bob Parsons (http://www.bobparsons.com). Copyright © 2004-2006 by Bob Parsons. All rights reserved.

Gosh, could these be applied to CME?
:)

ACCME posts clarification on expanded definition

Click here to read this clarification.

Retention of foreign object...

is one of 27 categories of medical errors that the Indiana Medical Error Reporting System utilizes. From the INDYSTAR.COM article:

State health officials said the error-reporting system is designed to give health-care providers useful information in understanding why errors occur and developing systems for preventing future errors. The officials also said they expect the number of reported errors to rise as hospitals become familiar with the program.

“Every health care provider takes adverse events seriously; even one adverse event is too many,” Kathy Rapala, interim director of the Indianapolis Coalition for Patient Safety, said in a statement. “The statewide report provides valuable information that we can use to guide our patient safety actions.”

Gov. Mitch Daniels ordered the Indiana Department of Health to begin collecting the information in 2005. But the preliminary report released today is the first comprehensive look at a full year.

Click here to read the entire article.

Congressional committee to look at off-label use issues

As reported today in the Wall Street Journal, a congressional committee will examine "the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration." Boston Scientific Corp. and Johnson & Johnson's Cordis unit, have been asked to provide clinical data and marketing materials on their drug-coated stent products to the House Committee on Oversight and Government Reform. In addition:

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.

Click here to read the article (subscription required).

The Boardman Incident

When Dr. Cecelia Boardman, a gynecologic oncologist at Virginia Commonwealth University's Massey Cancer Center, made statements before the Viginia General Assembly regarding the efficacy of the new Merck vaccine to prevent HPV infection, she apparently failed to disclose her financial relationship with Merck (per the newspaper article, she has given "educational talks" to physicians on the new vaccine). While she "didn't violate any disclosure requirement governing witnesses who give input to lawmaking committees" and no one, apparently, questions her credentials, she still ends up in the headlines. From the article:

"I'm most distressed and most apologetic and most concerned that there is any perception of my being dishonest or untruthful," Boardman said. "I have done a lot of public speaking on cervical cancer and cervical cancer prevention in my professional roles. In my mind, I did not feel any conflict in the testimony I provided."

She said she did not participate in Gardasil research and that she independently evaluated the drug's performance before coming to her conclusion that it works.

"If I thought the data was crummy, I'd say the data was crummy," she said.

Click here to read the entire article. I'd like to know if these "educational talks" were promotional or CME-certified presentations, one can never really tell from these news articles.

8 Pharma companies receive FDA Warning Letters

The FDA issued Warning Letters to eight (8) pharmaceutical companies regarding the unapproved use of drugs containing ergotamine tartrate for headache relief. From the ScientificAmerican.com article:

Like other approved products for migraine and other headaches, the drugs contain the active ingredient ergotamine tartrate. But they have been manufactured and distributed without undergoing review by the FDA, the agency said.

"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval," said FDA's Deborah Autor, who oversees compliance issues. She added that fewer than 2 percent of prescription medications are unapproved.

"Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," she said in a statement.

The unapproved ergotamine tartrate drugs do not carry necessary cautions against their use in patients also taking the metabolic enzyme inhibitor CYP 3A4 found on labels for similar approved headache drugs, the FDA said.

Such inhibitors can include certain antibiotics, antifungal treatments and protease inhibitors.

Click here to read the article. Click here to access the FDA Warning Letters.

Serotonin Syndrome

Remember the case of Libby Zion? If you don't, then be certain to read "A Mix of Medicines That Can Be Lethal" published in the New York Times. From the article:

In March 2005, two such specialists, Dr. Edward W. Boyer and Dr. Michael Shannon of Children’s Hospital Boston, noted that more than 85 percent of doctors were “unaware of the serotonin syndrome as a clinical diagnosis.”

In their review in The New England Journal of Medicine, Dr. Boyer and Dr. Shannon cited a report based on calls to poison control centers around the country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In 2005, the last year for which statistics are available, 118 deaths were reported.)

The experts fear that failure to recognize serotonin syndrome in its mild or early stages can result in improper treatment and an abrupt worsening of the condition, leading to severe illness or death. Even more important, in hopes of preventing it, they want doctors — and patients — to know just what drugs and drug combinations can cause serotonin poisoning.

Click here to access the article.

Prescription drug abuse

In a related International Narcotics Control Board press release on prescription drug abuse:

The demand for these drugs is so high, that it has given rise to a new problem – that of counterfeit products. Strong demand on the illicit markets of Scandinavia for flunitrazepam (Rohypnol®), a sedative, is increasingly met by illicitly manufactured counterfeit preparations. The demand of the illicit market in North America for OxyContin® has lead to distribution of counterfeit products containing illicitly manufactured fentanyl.

An equally serious consequence is that abuse of prescription drugs can have lethal effects. An increasing number of deaths related to abuse of narcotic drugs, including fentanyl and oxycodone have been recorded in North America and Europe.

Click here to read this press release (fyi, they have 2006 on the 1st page...should read March 1, 2007).

Counterfeit drugs a real issue!

The International Narcotics Control Board (INCB) issued a press release today on the dangers of counterfeit drugs:

“Besides the fact that the existence of unregulated markets, the sale of diverted and counterfeit drugs and the purchase of drugs containing controlled substances without prescription contravenes international treaties on drug control, it is important for consumers to realize that what they think is a cut-price medication bought on an unregulated market may however have potentially lethal effects whenever the consumed drugs are not the genuine product or are taken without medical advice. Instead of healing, they can take lives,” said Dr. Philip O. Emafo, President, INCB.

Click here to read the press release.

Putting the updated ACCME criteria in perspective...

Check out Josh Callman's new CME blog! I think his latest post might help y'all put the new ACCME criteria in perspective. Click here to access (also one of my links).

Cutting the risk of HIV transmission

Looks like male circumcision as a HIV transmission risk reduction method has been validated by two additional African studies:

In 2,784 men ages 18 to 24 in Kisumu, Kenya, researchers found the two-year HIV incidence was 2.1% in the circumcised men and 4.2% among controls -- a difference that was statistically significant at P=0.0065.

The risk reduction in the Kenyan trial was 53%.

In 4,996 men ages 15 to 49 in the rural Rakai district of Uganda, researchers found a two-year HIV incidence of 0.66 cases per 100 person-years in circumcised men and 1.33 cases per 100 person-years among controls, which was significant at P=0.006.
The risk reduction in Uganda was 51%.

Click here to read the MEDPAGE TODAY brief.

ACCME issues call for comments

The ACCME has issued a call for comments on proposed changes relative to:

1) Written agreements for commercial support

2) Expanded definition of a "commercial interest"

Click here to access the document. Deadline for comments is March 30, 2007.

Merck suspends lobbying efforts on new vaccine

Click here for the press release.

CDC Immunization Schedules -- handheld downloads now available

Handheld versions of the immunization schedules are now available (Palm OS® and Pocket-PCs®):

2007 Childhood & Adolescent Immunization Schedule - Click here (and scroll down).

2006-2007 Adult Immunization Schedule - Click here (and scroll down).

Graphics (jpg images) are also available for Childhood & Adolescent schedules for those of you building presentations on this topic.

Health literacy matters!

The Joint Commission (formerly the Joint Commission on the Accreditation of Health Care Organizations) has published a white paper "What Did the Doctor Say?:’ Improving Health Literacy to Protect Patient Safety" -- every CME professional should read this (I'm entitled to my opinion).
:)
Thanks to the Alliance for CME for including this in their e-newsletter! Click here to read the white paper.

"Top Gun" surgical simulation...

Looks like younger surgeons with video game experience might have the advantage when it comes to learning laparoscopic surgery techniques:

"It is likely that video game skills are a better predictor of demonstrated laparoscopic skills and suturing than years of experience with laparoscopy because many laparoscopic procedures do not require the advanced skill sets as measured in the course," they said.

While the researchers acknowledged indiscriminant video game playing is not a panacea, they suggested that the visuospatial and other skills acquired through video games may help physicians through the "learning curve" for laparoscopic procedures and thus improve patient safety.

Seems fairly intuitive... Click here to read the MEDPAGE TODAY summary of the original Archives of Surgery article.

Do physicians need spiritual CME?

Tracy Balboni, a radiation oncologist, conducted a survey of terminally ill cancer patients about their spiritual needs:

...Balboni found that 88% of terminal cancer patients said religion was at least somewhat important to them. And about half had been visited by clergy. Yet Balboni's research also suggests that hospitals, doctors and even religious communities fail to support the spiritual needs of their cancer patients at the end of life.

In her survey of 230 people with less than a year to live, nearly half say they received little to no support for their spiritual needs from religious communities. More than 70% say their spiritual needs weren't met by hospital chaplains or others in the health care system, says the study, published Saturday in the Journal of Clinical Oncology.

Click here to read the USA Today article.

"One in Three"

Just read a New York Times book review on the new book entitled "One in Three" written by Adam Wishart. Mr. Wishart relates the story of his father bout with cancer and how he personally coped with his father's ordeal...he sought knowledge and wrote this book:

Mr. Wishart reports that during his years of writing and talking casually about cancer, he had a horrifying effect on others. Hearing him, listeners would shiver or quail or walk away. But his book does not prompt that kind of response: Mr. Wishart has done copious research and used it to shape a story more gripping than frightening. In tribute to the intellectually adventurous spirit of his father, who responded to debilitating neck surgery by wearing a starched 16th-century-style ruff to hide his plastic collar, Mr. Wishart remains too erudite and civilized to succumb to fear.

The book apparently contains a fair amount of interesting history about cancer; for instance, ever hear of the "Radium Girls" of New Jersey? Neither had I...click here to check out the book review.

"When the moon is in the Seventh House..."

Interesting survey conducted of hospital visits by Peter Austin and colleagues at the Institute for Clinical Evaluative Sciences in Toronto. They found that "Virgos have an increased risk of vomiting during pregnancy, Pisces have an increased risk of heart failure, and Libras have an increased risk of fracturing their pelvises." Looks like the real purpose of the survey was to make this important point:

Austin said he found that even though each astrological sign had its own unique disorders, his initial results were not reproduced when they were explicitly tested in a second population.

"Scientists take pains to make sure their clinical studies are conducted accurately," said Austin. "But sometimes erroneous conclusions will be obtained solely due to chance."

Statistical chance means that 5 percent of the time, scientists will incorrectly conclude that an association exists, when in reality no such association exists in the population that the scientists are studying.

One way to reduce the chances of drawing a wrong conclusion is to try and reproduce unexpected results in further studies.

Click here to read the entire news article.

ACPE updates noncommercialism criterion

The Accreditation Council for Pharmacy Education has issued an update to ACPE Criterion 17 - noncommercialism. Basically, they adopted the 2004 ACCME Standards for Commercial Support of CME (with ACCME's permission). "Providers will be first evaluated by these guidelines beginning January 1, 2008." Click here to read the updated criterion. Click here to read the guidance document.

Practice makes purrrrrfect...

A touch of whimsy for a Friday. Click here to access Nora the cat at the piano.
:)

Practice guidelines published in American Family Physician

The latest issue of American Family Physician includes two practice guidelines:

Updated CDC Guidelines for the Treatment of STDs
Diagnosis and Management of Cough

Did you know that, on average, a family physician sees a patient every day with a cough? (Can't help myself, please note the Cough guidelines byline is that of Laura Coughlin...coincidence?).
:)
Click here to access these guidelines.

HEART for Women Act

Fitting, perhaps, to tell you about this for Valentine's Day! Several health care organizations have endorsed this legislative bill which is designed to make women's heart health a national priority:

"We know that heart disease affects women and men differently, but research has yet to deliver optimal screenings and treatments for women," said Phyllis Greenberger, M.S.W., President and CEO, Society for Women's Health Research. "Understanding of the issue, even among doctors, is still not where it should be. As the president's budget for health and research declines, we need Congress to take action."

Endorsing organizations include the American Heart Association, Association of Black Cardiologists, Inc., and the Society for Women's Health Research. Click here to read the article.

Would physicians take a cut in pay for a cut in paperwork?

The University of Minnesota School of Public Health conducted a study which "found that 63.4 percent of state physicians believe that a single-payer universal health insurance system would offer the best health care to the greatest number of people."

Dr. Charles Oberg, the study's co-author and associate professor at the University of Minnesota School of Public Health, commented, "Many doctors are becoming increasingly disappointed and frustrated with the health care system as it stands. Insurance hassles, heavy paperwork, and patients' inability to get the care they need make it very problematic."

The study also found that 71 percent of Minnesota doctors said they would accept a 10 percent reduction in fees for a "very significant" reduction in paperwork, and 63.8 percent favored physician payment under a salary system.

Click here to read the entire article.

Finding the balance between paternalism and patient autonomy?

Interesting study published in the New England Journal of Medicine "Religion, Conscience, and Controversial Clinical Practices." I find those intersections between medicine and culture and/or religion fascinating. Click here to access the free article (registration required).

The Prescription Project

From the press release:

Supported by The Pew Charitable Trusts, The Prescription Project is an initiative of Community Catalyst, a Boston-based health care advocacy organization, in partnership with the Institute on Medicine as a Profession (IMAP). Funded by a $6 million grant from Pew, The Prescription Project will work over the next two years with medical and consumer stakeholders, policy makers and both public and private payers to:

• Document the scope of the problem and its impact on health care quality and cost;
• Collaborate with leading Academic Medical Centers (AMCs), physician organizations, public and private health plans, consumer organizations, and policy makers to promote best practices in prescribing;
• Assist AMCs and professional medical societies in adopting policy reforms; and
• Undertake a wide range of policy initiatives in partnership with public and private payers to increase the use of evidence-based systems and reduce conflicts of interest.

Click here to read the entire press release. Thanks to Anne and Lois!

Unintentional poisoning deaths on the rise...

Disturbing statistics from this week's MMWR indicate that unintentional death from poisoning is the second leading cause of unintentional death (#1 is motor-vehicle crashes):

The mortality increases might be the result of greater use and abuse of potentially lethal prescription drugs in recent years, behaviors that are more common among whites than nonwhites (6,7). The substantial increase in deaths among persons aged 15--24 years is consistent with substantial recent increases in recreational prescription drug and cocaine use among adolescents and young adults (8).

Studies by state health agencies have reported recent increases in prescription-drug--poisoning mortality in rural communities (9,10), despite historically higher rates in urban areas. The South and Midwest regions, which had the largest relative and absolute increases among regions in this study, are the most rural regions of the country (4). Further research is needed to determine how differences in drug use, drug-abuse--control measures, and demographic characteristics (e.g., race/ethnicity) contribute to this pattern.

As with any study, there are limitations; click here to read the report.

No record that biopsy forceps had been sterilised...

Hospital infection control measures, or lack thereof, are a serious issue as illustrated by a probably rare case discussed in The Australian article "Hospital tools put kids in HIV risk":

ALMOST 100 children may have been infected with HIV or hepatitis as a result of being treated at Canberra Hospital with surgical instruments that had not been sterilised.

Health authorities are searching for patients who had a colon biopsy at the hospital between 1987 and mid-October last year.
...
"This is an isolated rare event in healthcare. It's very unfortunate that it has occurred but occasionally things like this will happen in hospitals."

An investigation by hospital staff found two biopsy forceps used to take tissue samples were routinely washed but not sterilised as required by national standards.

A tracking system records the sterilisation of all hospital equipment. However, there was no record that the two forceps had been sterilised during the past 20 years.

Click here to read the article.

Do we need combo pills in order to be compliant?

An online survey was conducted last year by Harris Interactive for a capsule supplier on patient medication compliance. From the recent Pharmexec.com article discussing these study results:

The results are provocative, providing clues for drug developers and marketers to better understand the health consequences, as well as the business ramifications, of intentional noncompliance. To take just one example: A large number of patients who alter their regimen suffer from two or more medical problems. One way for drug makers to decrease noncompliance rates might be to reformulate therapies for different health complaints in a single pill. A combo pill that treats two widespread chronic conditions could take advantage of the higher compliance that often comes with one disease and "apply" it to the other—a case of two birds with one stone. With at least one in six Americans taking three or more prescription meds, tailoring drug delivery to more specific patterns may prove a valuable innovation.

Click here to read the article.

There are two ends to the stethoscope...

Ever wonder what physicians complain about regarding their patients and vice versa? A Washington Post article discusses the findings of a survey conducted by the Consumer Reports National Research Center:

Among patients' biggest grumbles, found the survey conducted by the nonprofit Consumer Reports National Research Center and published in the February issue of Consumer Reports: doctors' failure to divulge the cost of medications or office visits (cited by two-thirds of respondents); failure to mention medication side effects (cited by almost one-third); doctors who couldn't see them within a week (19 percent); and doctors who don't return tests results promptly (7 percent).

For their part, doctors took umbrage with patients for not "following their prescribed treatment," waiting too long to make an appointment and being reluctant to discuss their symptoms.

Click here for the article. Now I can't get that Joni Mitchell song, "Both Sides Now" out of my head.
:)

Effectiveness of CME...

The Evidence-based Practice Center at Johns Hopkins University prepared a report for the Agency for Healthcare Research and Quality entitled "Effectiveness of Continuing Medical Education." From the report (hey, I'm a bottom line type of gal):

Conclusion: Despite the low quality of the evidence, CME appears to be effective at the acquisition and retention of knowledge, attitudes, skills, behaviors and clinical outcomes. More research is needed to determine with any degree of certainty which types of media, techniques, and exposure volumes as well as what internal and external audience characteristics are associated with improvements in outcomes.

Click here to access the 500+ page report. Of course, they didn't include my fabulous journal article published in 1997 in the Western Journal of Medicine. For those of you interested in "ancient" history, click here to read said article. With that article and $4, I can buy a Cafe Mocha!
:)

It's now the law in Texas...(effective September 2008)

Governor Richard Perry (R) has side stepped the Texas State Legislature and signed a new bill which requires sixth-grade girls in the state to be vaccinated with Gardasil. Gardasil, as you might already know, is Merck & Co.'s new vaccine for prevention of cervical cancer caused by strains of the human papillomavirus (HPV). From the International Herald Tribune article:

Texas allows parents to opt out of inoculations by filing an affidavit objecting to the vaccine on religious or philosophical reasons. Even with such provisions, however, conservative groups say such requirements interfere with parents' rights to make medical decisions for their children.

The federal government approved Gardasil in June, and a government advisory panel has recommended that all girls get the shots at 11 and 12, before they are likely to be sexually active.

Click here to read the entire article. What are your thoughts on this issue?

Resources on pandemic flu...

Here are some resources for information on pandemic influenza (in no particular order):

"Pandemic and Seasonal Influenza Principles for U.S. Action" from the Infectious Diseases Society of America. Click here.

PandemicFlu.gov..."One-stop access to U.S. Government avian and pandemic flu information. Managed by the Department of Health and Human Services". Click here.

"Epidemic and Pandemic Alert and Response" from the World Health Organization. Click here.

Women and heart disease...

The American Heart Association and several other national sponsors are urging women to “Go Red for Women” Day this Friday. Women can supposedly go to www.GoRedForWomen.org and complete an online assessment of their heart health; however, I couldn't get into the assessment. There is a “Go Red for Women” brochure available on steps to take for heart health and you can click here to access it.

On a personal note, the 60-year-old wife of a dear family friend visited her physician last week because she had a pain in her shoulder and was not feeling well. The physician sent her home; a few hours later she called her husband at work because she was feeling worse. He quickly drove home and transported her to the ER. Yes, you're correct in thinking that she was having a heart attack; unfortunately, she had a second heart attack shortly after being admitted. She did receive treatment (stents) and, I'm happy to report, is now in fair condition. Women, please educate yourselves on this important issue, click here for American Heart Association information on heart attack warning signs.

Changes at the FDA...

The Food and Drug Administration announced some changes to monitor the safety of drugs. One strategy is to make an assessment of a drug once it's been on the market for 18 months. A second strategy is to form "an advisory panel to improve the way it announces safety worries." Apparently, this isn't good enough for Senator Christopher J. Dodd (Democrat, CT):

Mr. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans. The bills’ co-author, Senator Charles E. Grassley, Republican of Iowa, has called the agency far too “cozy” with drug makers.

Ummmm...from the article:

There are now thousands of drugs in routine use. Figuring out which of these medicines may have undiscovered side effects will take a lot of money. The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs.

That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.

Fasten your seatbelts...(sorry, that's my "homage" to "All About Eve")! Click here to read the entire New York Times article (registration required).

Health literacy still an issue...

As reported in the New York Times article "The Importance of Knowing What the Doctor Is Talking About," health literacy, or rather the lack thereof, is an issue for all patients. How can patients comply with doctor's orders when they never understood them in the first place? Some tips from the article for patients:

Do not wait until doctors become better at communicating. If you want the best medical care, you have to take the initiative. If the doctor says something you do not understand, ask that it be repeated in simpler language. If you are given a new set of instructions, repeat them back to the doctor to confirm your understanding. If you are given a new device to use, demonstrate how you think you are to use it.

Insist that conversations about serious medical matters take place when you are dressed and in the doctor’s office. Take notes or take along an advocate who can take notes for you. Better yet, tape-record the conversation to replay it at home for you and your family or another doctor.

Click here to read the entire article (registration required).

HealthGrades names Distinguished Hospitals for Clinical Excellence

HealthGrades has issued their annual study on hospital quality and clinical excellence (now in its fifth year):

The 2007 study found that 158,264 lives may have been saved and 12,410 major complications avoided during the 3 years studied, had the quality of care at all hospitals matched the level of those in the top five percent. These major complications include problems like post-op pneumonia, post-op respiratory failure, post-op bacterial infections, or post-op bleeding.

To name hospitals in the top five percent for clinical excellence, the HealthGrades’ study analyzed nearly 39 million hospitalizations over the years 2003, 2004 and 2005 at all 4,971 of the nation’s nonfederal, nonchildren’s, short-term acute care hospitals.

Click here to read the press release on the study. Click here to access the general HealthGrades website.

Is pay for performance akin to the radical mastectomy procedure?

Check out the latest issue of the New England Journal of Medicine and read the article by Lindenauer, et al "Public Reporting and Pay for Performance
in Hospital Quality Improvement." Interesting, interesting results...

Also suggest y'all read the editorial "Pay for Performance at the Tipping Point" by Arnold M. Epstein, M.D. As Doctor Epstein points out in his editorial:

Given this dearth of solid evidence, it seems apt to compare our adoption of pay for performance with our adoption of new surgical procedures or medical therapies. Many of my clinical colleagues would insist on hard evidence documenting efficacy before endorsing a new therapeutic approach. They cite sobering stories of what can happen when we introduce new approaches prematurely. Consider, for example, the numerous surgical procedures or medical therapies — including radical mastectomy for women with early-stage breast cancer and hormone-replacement therapy for postmenopausal women — that were diffused widely before solid evidence of their relative efficacy was available, only for us to learn later that they were, at best, no more effective than alternative therapies or, at worst, harmful.8-10 If pay for performance were a therapy, its rapid diffusion thus far would have to be considered premature.

Click here to access these free, early release articles. Thanks, NEJM!

Talk about a conflict of interest?

According to the New York Times, Connecticut's attorney general has pressured a consulting group of hospital executives, the Healthcare Research and Development Institute (HRDI), to agree to "stop selling marketing advice to vendors who do millions of dollars in business with nonprofit hospitals across the nation, including their own." Gee, is that a conflict of interest? Duh!

The agreement, Mr. Blumenthal said, “shatters an anticompetitive, secret society, an elite and exclusive club of premier hospital executives and select hospital supply businesses that restrained competition to the detriment of patients and providers.”

The settlement, he said, did not end his investigation of hospital vendors.

H.R.D.I., which was founded five decades ago as an educational group, will change from a profit-making company into a nonprofit group financed only by hospitals or their executives. Supply companies may not initially join the new group, called the Health Education Network, nor will they be permitted to have any financial links to it.

The settlement, under which the group agreed to pay a $150,000 fine, ends a two-year investigation by Mr. Blumenthal, who found that some suppliers had increased their sales at hospitals run by H.R.D.I. members after paying consulting fees to those members, investigators said. The names of those vendors and hospitals were not included in the settlement agreement, which applied only to H.R.D.I. and not individual members.

Click here to read the entire article.

Harvard study shows rise in nicotine content in cigarettes

A study by the Harvard School of Public Health indicates that nicotine content in cigarettes rose by approximately 11 percent between 1998 and 2005. From the Thanhniennews.com article:

Nicotine yields rose in cigarettes of each of the four major manufacturers and across all major cigarette market categories – from mentholated and non-mentholated to full-flavored, light and ultralight, the study said.

Tobacco industry officials were not immediately available to comment. Phillip Morris, part of Altria Group Inc and the largest cigarette maker, has said nicotine levels fluctuate from year to year but there has been no steady increase.

Click here to read the entire article.

2007 Alliance conference

I attended the 2007 Alliance for CME conference held last week in Phoenix, AZ; as always, had a great time catching up with my CME colleagues. I spent some time at the Thursday night reception chatting with Patrick G. Moran, M.D., who also consults in CME. Doctor Moran is a Fellow of the ACME and just an absolutely delightful gentleman. I thank him for taking the time to visit with me and share some of his experiences over the years. While you might expect me to write about the sessions (the new ACCME criteria, evaluation, challenges, etc.), I'd rather tell you about the quality of people I personally know in CME. They work at all levels in CME; they have different backgrounds, education, and experience. One thing I know for certain (do I sound like Oprah?) is that CME is a good "place" because of the quality of the people who work there.

More on electronic prescribing

Here are some interesting statistics from the Time.com article "Cause of Death: Sloppy Doctors":

SureScripts CEO Kevin Hutchinson says one key to reducing medication errors is to get the most prolific prescribers to transition to electronic processing. "Not a lot of people understand that 15% of physicians in the U.S. write 50% of the prescription volume," Hutchinson says. "And 30% of them write 80%. So it's not about getting 100% of physicians to e-prescribe. It's about getting those key 30% who prescribe the most. Then you've automated the process."

Click here to read the entire article.

Free electronic prescribing for U.S. physicians

This is pretty interesting -- the National ePrescribing Patient Safety Initiative is a coalition of some tech companies and healthcare organizations seeking to improve patient safety. From their press release:

eRx NOW™ offers physicians and patients the highest levels of security available, with multiple redundant layers of firewall, deep-packet inspection, SSL encryption, database encryption, intrusion detection and virus, spyware and malware protection for the program’s remote servers. To ensure patient privacy, all patient information is stored on remote servers in a secure location, so information cannot be compromised even if a physician’s computer or phone is stolen.

Interested physicians can visit the NEPSI web site, www.nationaleRx.com to register for the program. The solution is currently being used by physicians and will begin national deployment within 30 days.

Click here to access the NEPSI website.

Bariatric surgery stats

Statistical Brief #23 from the Healthcare Cost and Utilization Project (HCUP) reveals the following interesting information on bariatric surgery in the United States:

From 1998 to 2004, the total number of bariatric surgeries increased nine-fold, from 13,386 to 121,055.

Across all age groups, the fastest growth in bariatric surgeries occurred among adults aged 55 to 64, a twentyfold increase, from 772 surgeries in 1998 to nearly 16,000 surgeries in 2004.

The national inpatient death rate associated with bariatric surgery declined 78.7 percent, from 0.89 percent in 1998 to 0.19 percent in 2004. In 2004, 230 patients died in hospital stays during which bariatric surgery was performed.

An increasing number of adolescents (12–17 years old) are receiving bariatric surgery, an estimated 349 in 2004.

Women accounted for 82.0 percent of all bariatric surgeries in 2004.

Click here to access this statistical brief. Click here to access HCUP's website; CME Providers might want to bookmark it.

ACCME posts toolkit to support implementation of the Updated Accreditation Criteria

Click here for toolkit.

Did Ernest gets his cat back?

Hercules (or Goliath) the cat went missing when his owner, Geoff Ernest of Portland, traveled to Seattle for a lung transplant a few months ago. How was Hercules found?...click here to view the video.

Will this improve quality of hospital care?

Looks like heart attack and heart failure death rates will be listed on Hospital Compare, a government website. From the USA Today article:

Some hospital administrators, though they support the goal, say the statistics may be misleading.

"It clearly needs to be done, but I'm not sure 30-day mortality is the right measure," says Gary Noskin of Northwestern Memorial Hospital in Chicago. "A patient could have a heart attack (and be treated successfully) and get hit by a bus after he leaves the hospital."

Medicare officials counter that the statistical methods used in the analyses highlight patterns of care, good or bad, not individual cases. The approach was approved by the National Quality Forum, a consortium of professional organizations, businesses, consumer groups, hospital chains and health plans.

Hospital Compare is an interesting website and I think CME Providers should be aware of the information it contains. Click here to read the entire article.

Two national healthcare reports issued

The Department of Health & Human Services and the Agency for Healthcare Research and Quality issued the results of the 2006 National Healthcare Quality Report and National Healthcare Disparities Report. Both of these reports found that use of proven prevention strategies needs to be improved:

Fewer than half of obese adults reported being counseled about diet by a health care professional. About one-third of American adults are obese, increasing the risks of high blood pressure, type 2 diabetes, stroke, heart disease and osteoarthritis. The Task Force recommends "intensive counseling and behavioral interventions" for obese adults.

Only 48 percent of adults with diabetes received all three recommended screenings—blood sugar tests, foot exams and eye exams—to prevent disease complications. AHRQ estimates about $2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications.

On a bright note, the National Healthcare Quality Report found that quality has improved for hospital care for heart attack patients by 15 percent and by 11.7 percent for pneumonia patients. Click here to read the entire press release. Click here for the National Healthcare Quality Report, and here for the National Healthcare Disparities Report. Okay, that's enough clicking for a Friday!
:)

Bush would veto legislation for Federal negotiation of Medicare drug prices

The word from the White House Office of Management and Budget is that President Bush would veto any legislation that would rescind the current noninterference clause in the Medicare prescription-drug law. In addition, this information from the same MarketWatch.com article:

The Health and Human Services Department on Monday released new figures showing that the estimated cost of the drug plan were lower than originally anticipated, thanks to competition between drug-plan providers.

The administration now expects the drug benefit to cost $640 billion between 2006 and 2015, down from its initial estimate of $926 billion.

Click here to read the entire article.

Doctors and dying...new book

William Grimes, in the New York Times, reviews "Final Exam," a new book written by Pauline W. Chen, M.D. From the review:

Outside the conferences, death is the unwelcome, awkward visitor who stops conversation. Dr. Chen cites a survey showing that one-quarter of oncologists failed to tell their patients that they were suffering from an incurable disease. Nearly half of the doctors in another study rated themselves as “poor” or “fair” in breaking bad news to their patients. Often, with several specialists and sub-specialists assigned to a dying patient, each doctor waits for the other to provide unwelcome information.

Dr. Chen experiences an epiphany when she witnesses a break with tradition. Normally, in a patient’s final hours, doctors close the curtain around the bed and disappear, leaving family members alone with their dying relative. But one doctor, trying to console an elderly woman whose husband is dying, stays with her by the side of the bed. As she holds her husband’s hand, he tells her what the strange sights and sounds on the monitors are saying, and what her husband is experiencing as life ebbs away. That scene of compassion and communication, in the midst of high-tech beepings and buzzings, shows what doctors can do when nothing can be done.

Click here to read the entire review.

Arnie's health care reform plan

California Governor Arnold Schwarzenegger (who is recovering from a broken leg) has announced a health care reform plan which will require coverage for all Californians:

Speaking about his plan for the first time via a video link to a meeting of healthcare stakeholders, Governor Schwarzenegger said this was not a question of whether everyone should be covered, the legislation already says they must, but a matter of how to pay for it. He is proposing to spread the cost among individuals, businesses, insureres, government, and healthcare providers.

Under his scheme, all citizens will have to be insured, with the poorest being helped through subsidies. One of the biggest shocks will come to the small and medium business sector, where those employing 10 people or more will either have to offer insurance to their employees or pay 4 per cent of their payroll to a state scheme. Hospitals will also have to pay 4 per cent of their income, and doctors 2 per cent.

Click here to read the entire article.

Brain hemorrhages associated with warfarin use on the rise

A study just published in the January 9, 2007 issue of Neurology reports a ten-fold increase in the incidence of brain bleeds in patients using warfarin. From the article:

"Warfarin use increased during the 1990s, because it was proven to be effective in preventing ischemic strokes among people who have an abnormal heart rhythm called atrial fibrillation," said the study's lead author, Dr. Matthew L. Flaherty, a neurologist.
...
Flaherty thinks that doctors need to be cautious in prescribing warfarin, especially to patients over 80. "Some of those patients are better off being on warfarin," he said. "The message isn't that no one should use warfarin. There needs to be a balance between the benefit of preventing ischemic stroke and the risk of bleeding."

Click here to read the Forbes.com article.

Physician executives burned out?

The American College of Physician Executives surveyed 1,200 physician executives about their current morale, and the survey results were published in the November/December 2006 issue of The Physician Executive. Here are some of the survey results:

Low reimbursement rates and loss of autonomy were the top two reasons for poor morale.

Bureaucratic red tape, patient overload, loss of respect and the medical liability environment were among the other reasons physicians cited.

Those work problems caused fatigue in 77% of physicians, emotional burnout in 67% and marital/family discord or depression in about one in three physician respondents.

Click here to read the AMNEWS article (a subscription is required to read the entire article).

Review of 2006 health issues by WHO

Click here to view a slide presentation prepared by the World Health Organization on 2006 health issues. It provides information on major world health topics from AIDS to XDR TB.

"Dr. New York"

Read a great article in the New York Times on Dr. Herbert Pardes who is President of the NewYork-Presbyterian Healthcare System. The historical information in the article is fascinating as is the delineation of the challenges inherent in trying to bring two major health care institutions into one system. From the article:

In taking the helm of NewYork-Presbyterian, Dr. Pardes, the nation’s first psychiatrist to run a major medical center and hospital, encountered a corporate version of a dispirited patient plopped on his sofa. The merged entity he inherited was gargantuan, its work force able to fill three Madison Square Gardens. Its organizational chart — with 52 hospitals, nursing facilities and specialty care centers and five campuses — was labyrinthine.

Dr. Pardes’s turnaround strategy, by comparison, was relatively simple: restructure the management team to make hospital administrators more nimble and accountable for performance, root out excessive spending to improve profit margins and bolster revenue by becoming the hospital of choice in the city.

As it turned out, the hospital’s most dire issue was cultural, Dr. Pardes said. Worried about losing power in the merged enterprise, for example, physicians from each predecessor hospital had banded together and refused to relinquish any area of care to the other hospital. Dr. Pardes was witnessing similar tensions play out in 1998 when Mount Sinai and New York University Hospital fused their medical schools.

Click here to read the article.

American Society of Hypertension will include COI panel

ASH has reversed its decision to cut a panel discussion on industry influence on medicine from its May 2007 conference agenda:

The society said the original session, titled "Conflicts of Interest," was kept off the agenda of its annual meeting because the proposed lineup of panelists lacked balance.

After the cancellation was reported by the Globe last week, the society's associate executive director, Melissa Levine , said in an e-mail that the society had now decided to add the panel discussion to the agenda for the May meeting in Chicago.

The society is "committed to conducting a session on conflicts of interest," Levine said. "Over the next few weeks we will be working to finalize the session and confirm the speakers."

But the inclusion of drug industry defenders led one of the original invited panelists, Dr. Marcia Angell , former editor of the New England Journal of Medicine, to question the society's motives, even though she is considering taking part in the session.

Click here to read the most recent Boston Globe article on this news item.

New W.H.O. director general

She is Dr. Margaret F. C. Chan, a graduate of the medical school of the University of Western Ontario in Canada and a former Hong Kong health chief. Dr. Chan was appointed director general in November 2006 and her term will end June 2012. Dr. Chan identified two major goals for her new role as W.H.O. director general -- "to improve the health of Africans and of women throughout the world." More from the New York Times article:

“Women do much more than have babies,” Dr. Chan said in a statement on the agency’s Web site. Speaking to reporters yesterday by telephone from the health organization’s headquarters in Geneva, she added that women were a rising influence in the work force and in their communities — particularly since so many teachers and health care workers were women.
...
Dr. Chan is the first person from China to head a United Nations agency. China has been criticized severely for not sharing information with the world about diseases like influenza and SARS, or severe acute respiratory syndrome. Asked whether she felt pressure to favor China, Dr. Chan pledged to be fair, transparent and accountable. “As an international civil servant, I commit to serve the interests of the member states of the organization,” she said.

“When the evidence is clear and health is at stake, the director general must be prepared to take a stand on difficult, and at times political, issues that affect health,” she said.

Click here to read the New York Times article.

IFPMA issues press release on new marketing code

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) issued a recent press release on their new marketing code which became effective January 1, 2007:

The new Code, whose applicability extends to every country and is required of all IFPMA members, imposes even stricter and clearer requirements on pharmaceutical companies, to ensure the ethical promotion of their products to health care professionals.

IFPMA Director General Dr. Harvey E. Bale said: “The updated provisions of our new Code reflect the industry’s concern to underscore that its life-saving products are promoted in an ethical manner. They apply in every country around the world, and we have taken particular care to prepare member associations and companies for the advent of the new Code; indeed, we started communicating it to them back in June of last year, to ensure they would have adequate time to prepare for its stricter provisions regarding international events, company sponsorship of health care professionals, the provision of hospitality and entertainment, as well as its more precise definitions of acceptable gifts.”

Click here for the press release and click here for the English version of the new code. Will this new code make it easier to comply with the ACCME Standards for Commercial Support of CME when CME activities take place in non-U.S. countries?

Additional settlement from Lilly

Eli Lilly has agreed to settle 18,000 lawsuits on Zyprexa and pay out $500 million. This is in addition to the lawsuits they previously agreed to settle, which now brings Lilly settlement costs on Zyprexa lawsuits to $1.2 billion. From the New York Times article:

"The documents also show that Lilly marketed the drug as appropriate for patients who did not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drug makers may promote their drugs only for diseases for which the Food and Drug Administration has found the medicines to be safe and effective, though doctors may prescribe drugs in any way they see fit.

In response to questions about the information in the documents, Lilly has denied any wrongdoing and said it provided all relevant information to doctors and the F.D.A. Lilly has also said it did not promote Zyprexa for conditions other than schizophrenia or bipolar disorder."

Apparently there are more Zyprexa lawsuits pending. Click here to read the entire article. It would be interesting to know exactly how Lilly allegedly promoted off-label uses of Zyprexa -- do the "documents" include certified CME activities?

2007 Childhood and Adolescent Immunization Schedules

Practice guidelines relative to the 2007 childhood and adolescent immunization schedules have been published in the American Family Physician. The guideline source: Advisory Committee on Immunization Practices, American Academy of Pediatrics, American Academy of Family Physicians. "Published sources: Morbidity and Mortality Weekly Report, January 2007; Pediatrics, January 2007; American Family Physician, January 1, 2007." Click here to access these practice guidelines.

To read an editorial on the HPV vaccine written by Jonathan L. Temte, M.D., PH.D., University of Wisconsin School of Medicine and Public Health, click here.

The medicalization of life

Everyone has an opinion and the authors of this New York Times essay -- "What’s Making Us Sick Is an Epidemic of Diagnoses" -- certainly have theirs. They do make some good points on which to ponder:

"For most Americans, the biggest health threat is not avian flu, West Nile or mad cow disease. It’s our health-care system.

You might think this is because doctors make mistakes (we do make mistakes). But you can’t be a victim of medical error if you are not in the system. The larger threat posed by American medicine is that more and more of us are being drawn into the system not because of an epidemic of disease, but because of an epidemic of diagnoses.

Americans live longer than ever, yet more of us are told we are sick.

How can this be? One reason is that we devote more resources to medical care than any other country. Some of this investment is productive, curing disease and alleviating suffering. But it also leads to more diagnoses, a trend that has become an epidemic."

Click here to read the entire essay.

Diatribe on pharma sales reps?

It may sound like the title of a B movie, but "Attack of the Pharma Babes," a Time article written by Dr. Scott Haig gives one doctor's perspective on pharma sales reps, DTC advertising, HMOs, and hospitals. He might even make you crack a smile. Click here to read the article.

1st-year residents and preventable medical errors

A study by the Agency for Healthcare Research and Quality and the National Institute for Occupational Safety and Health revealed there is a 300 percent rise in the chances of first-year residents making preventable adverse events when they work five extended shifts (24 hrs or more) in one month's time. From the press release:

"Laura K. Barger, Ph.D., a research associate in medicine at Brigham and Women's Hospital and Harvard Medical School in Boston, and her colleagues analyzed the results of a national, Web-based survey in which 2,737 interns completed 17,003 monthly reports. Researchers assessed the association between the number of extended-duration shifts worked in the month and the reporting of significant medical errors, preventable adverse events, and attentional failures.

The findings are significant because interns routinely work extended shifts in teaching hospitals. Guidelines for graduate medical education in the United States still allow up to nine "marathon" shifts (30 hours at a stretch) per month, even though the total number of hours worked is capped. This study shows that the long shifts worked by interns are bad for patient safety, as they are more likely to cause harm that would not otherwise happen."

Leist named Alliance Interim Executive Director

Harry A. Gallis MD, President, Alliance for CME just announced via the Alliance member listserve that he has appointed James Leist, EdD, as the interim Executive Director. Jim will begin his duties on February 1, 2007. Please join me in congratulating Jim on this appointment.
:)

Smoking cessation by story

The power of story is now being used in anti-smoking advertisements, as reported in a recent New York Times article:

"Antismoking ads have changed a lot from the days when commercials gloomily listed health risk after health risk in an attempt to persuade smokers they should quit. Most smokers already know they should quit, and they usually try to do so eight times before they succeed, according to the American Legacy Foundation, a nonprofit group that fights smoking.

Messages from real people seem to be more persuasive to smokers, the foundation says. In 2006, the foundation continued its Truth campaign aimed at deterring teenagers from smoking with documentary-style commercials featuring a bushy-haired young man investigating the tobacco industry in an aggressive but funny manner."

The article also discusses the advertisement of smoking cessation products which includes telling the stories of real people who are trying to quit smoking. Click here for the full article.

Harmony and balance...a Frenchman and his horses

As we close 2006 and look forward to 2007, I wish y'all harmony and balance in your lives. Click here to view a short video on what is possible.

Salah ad Din Province CME

Click here for an interesting article on continuing medical education in Iraq.

More on suicide risk screening

"Anonymous" posted a comment on the TeenScreen item and so I am posting a link here to the December 2004 issue of the American Family Physician article which delineates the U.S. Preventive Services Task Force recommendations on screening for suicide risk.

Per the Centers for Disease Control, "For Americans ages 15 to 24, suicide is the third leading cause of death." Click here for the CDC's Injury Fact Book.

Simple measures...

An article in the Baltimore Sun discusses the findings of a study just published in the New England Journal of Medicine on the impact that simple infection control measures had on reducing Michigan hospital infection rates. It's not always a knowledge deficit, folks, health care is delivered in an environment (with its own culture) and the systems need to be in place to optimize the quality of care provided. Involve everyone on the health care team -- yes, provide them with the knowledge, but set up the systems so that they have the skills, resources, and tools to apply that knowledge!

Mental health screening program for teens

Since half of all serious psychiatric disorders surface sometime between the ages of 14 and 25, it makes sense to screen teens for mental illness. A recent article in the New England Journal of Medicine reports on the success of TeenScreen, in which more than 55,000 teens in 42 states were screened. Click here to read the abstract. Fyi, a pdf of the entire article is available free -- THANKS to the NEJM!

Medical gains and new challenges

This New York Times essay by Lawrence K. Altman, M.D. is definitely worth reading -- "So Many Advances in Medicine, So Many Yet to Come" -- it's a great history lesson on the past 50 years of medicine but also highlights, methinks, the importance of continuing medical education.
:)

German company wins pharmaceutical packaging award

Came across a news article about a European competition for pharmaceutical packaging. The winning company, Faller, won this award because its design not only met customer needs in terms of functionality but also included a "means for recording" when tablets are taken. Click here for the article.

"ACCME Asked to Provide U.S. Senate Finance Committee with Information Regarding CME"

Click here to read the ACCME's news release on this matter.

Pharma company to pay $499 million in settlement?

"Bristol-Myers Squibb Co. on Thursday said it has tentatively agreed to pay $499 million to settle a long-standing probe by the Department of Justice into its marketing and pricing practices." The company has agreed to enter into an agreement with the DOJ and and the Massachusetts U.S. Attorney's Office to settle this investigation. "In return, there will be no criminal charges filed against the company. Bristol-Myers added that the deal had not yet been finalized." Click here to read the entire MarketWatch article.

A new model for surgical skills training

Very good article just published in the New England Journal of Medicine "Teaching Surgical Skills — Changes in the Wind". The authors discuss the Fitts–Posner Three-Stage Theory of Motor Skill Acquisition as well as several training and assessment models. All good stuff for CME Providers to be well versed in, especially in light of the new ACCME accreditation criteria.

Take the food portion quiz!

Hate to do this just before those big dinners and all the holiday goodies, but I'm sharing this CNN online quiz "Portions, Past and Present" just in case it helps y'all even a little bit in 2007. FYI, I failed this quiz miserably.

Definitions count

Which is more important -- the Institute of Medicine's definition of a medical error or a patient's definition of a medical error? A study published in the January 2007 issue of the Joint Commission Journal on Quality and Patient Safety indicates that patients may have their own definition of what constitutes a medical "error" or "mistake":

“'The study underscores that patients and clinicians can have different views of the things that constitute a medical error,'” says Dr. Burroughs. “'For patients, clear communication and responsiveness are particularly important. If these are lacking, patients may view this as a medical error. It is important that clinicians recognize these differences, and the importance of communication and responsiveness.'”

Click here for the press release on this study.

An unintended consequence

The issue of a specific medical technology and its unintended consequence are discussed in this Washington Post article "Devices Can Interfere With Peaceful Death: Implants Repeatedly Shock Hearts Of Patients Who Cannot Be Saved". Frankly, I had never thought of this issue until I read this article!

"The implants -- small, internal versions of the paddles that emergency rooms use to shock patients' malfunctioning hearts -- are saving many lives. But in some cases they also are making the act of dying harder, forcing terminally ill patients and families to make wrenching decisions about turning them off. The devices subject some dying patients to painful jolts and can prolong suffering, traumatizing loved ones as the devices fire fruitlessly."

Henry Ford cracks down on vendors

Henry Ford Health System is the latest large health care system to formalize and implement policies and procedures "aimed at eliminating potential conflict of interest between relationships with vendors and employees." A novel component of Henry Ford's new P&Ps is a certification program for vendors. The cost of the certification program is $100 (per person?). Bottom line:

"Promotional products of any kind, food supplied by vendors or literature distributed by vendors, will no longer permitted at any Henry Ford site."

I think they mean "...will no longer be permitted..."; in any event, we get the point.

Has the "grand" gone out of rounds?

Read an interesting article in the New York Times, "Socratic Dialogue Gives Way to PowerPoint," written by Lawrence K. Altman, M.D. Doctor Altman describes the history of grand rounds and how they have changed:

"Precisely when and where grand rounds began is not known. There are many types of rounds where doctors learn from patients. For example, there are the daily working rounds as doctors walk through a hospital to visit and examine patients. In teaching rounds, more senior doctors supervise the work of residents, or house officers, at a patient’s bedside or in a clinic.

Grand rounds were showcases featuring the best clinicians, and the practice thrived in an era when doctors knew little more than what they observed at the bedside. Professors often demonstrated characteristics of physical findings like an enlarged thyroid, a belly swollen with fluid or another grotesque disfigurement that the audience could see. Those with a flair for showmanship were often the best teachers, adapting the predictable structure to their needs and talents."

Doctor Altman describes how grand rounds have evolved, and perhaps not for the better. In any event, I recommend y'all read the article...look for the Lollipop case.

It's the patient outcomes that count

Do hospitals that perform better on quality measures have the best patient outcomes? A study published in JAMA tried to determine just that...from the Washington Post article reporting on this study:

"Patients at hospitals that scored near the top on the quality-of-care measures did do better than those at hospitals near the bottom -- but not dramatically so.

For every 1,000 heart attack patients, there were about five fewer deaths at the better-performing hospitals than at the lower-performing ones, the study found. The figures were similar for patients with heart failure and pneumonia.

Rachel M. Werner, an assistant professor of medicine and the study's lead author, said the results point up the need for more meaningful quality measures."

New CME requirement for Dubai docs

Per a new ruling from the UAE Ministry of Health, physicians practicing in the public sector will now need 50 hours of CME every year in order to renew their medical licenses. The new ruling takes effect January 1, 2007:

"While many private sector hospitals already stipulate their own minimum number of CME hours doctors must attend, at present, there are no laws to ensure public sector medical practitioners - including doctors, dentists and nurses - do the same. And Dr Abdul Ghaffar Abdul Ghafoor, assistant undersecretary for curative medicine, at the Ministry of Health, said this move is vital to ensure Dubai’s doctors keep up-to-date with advances in treatment methods."

More on drug-eluting stents

An expert panel convened by the FDA has issued caution in the use of drug-eluting or drug-coated stents, indicating that both physicians and patients be fully informed of the risks associated with their use. See the New York Times article "Panel Urges Caution on Coated Stents" for additional information.
Also, see the Duke Med News article "Drug-Coated Stent Patients at Risk if Anti-Blood-Clotting Medication Discontinued" for an excellent description of the rather complex issues on the use of drug-eluting stents and why more research is needed.

Proposed JCAHO Patient Safety Goals 2008

The Joint Commission on the Accreditation of Healthcare Organizations has released their proposed 2008 Patient Safety Goals. A new topic area goal is sleep apnea:

"The problem for sleep apnea patients following surgery is they can’t wake themselves up under heavy sedation, according to Kevin Finkel, MD, an anesthesiologist at Barnes Jewish Hospital in St. Louis, MO, speaking to HCPro's Quality Improvement Report newsletter. About 90 percent of sleep apnea patients are undiagnosed, he said. For that reason hospital staff needs to look for signs of the condition and ask patients if they snore. Patients who are obese or have a neck circumference of more than 17 inches are also at more likely to have sleep apnea."

The JCAHO is seeking input on the proposed 2008 Patient Safety Goals.

Conflict of interest charge for NIH scientist

Dr. P. Trey Sunderland III is the first NIH official since 1992 to be charged by federal prosecutors with conflict of interest. According to the LA Times article, Sunderland, in charge of the NIH's geriatric psychiatry division, received money from Pfizer, Inc. from 1998 to 2003 without NIH's permission or knowledge. Alledgedly, Sunderland provided Pfizer, Inc. with spinal-tap samples from patients and "failed to note his company fees and additional expense reimbursements on annual NIH financial reports."

December issue of Medical Meetings magazine published

"Aiming High" is the title of the lead article on the new ACCME accreditation criteria. The writer of the article is the virtuoso with a pen (or is that a keyboard?), Sue Pelletier. The article is a timely read, as they say...
:)

American Academy of Pediatrics issues policy statement

Apparently, several Western countries as well as Denmark, Belgium and Greece, Sweden, and Norway limit advertising to children, but the United States does not limit such targeted advertising. That's why the American Academy of Pediatrics has issued a policy statement on advertising to children; this statement will appear in the December issue of Pediatrics. The statement is critical of:

"...alcohol ads that feature cartoonish animal characters; fast-food ads on educational TV shown in schools; magazine ads with stick-thin models and toy and other product ''tie-ins'' between popular movie characters and fast-food restaurants."

Let's hope that policymakers listen.

Participate in an international survey on patient safety

The World Health Organization (WHO) is calling for health care professionals and patient advocates from around the world to participate in an online survey on nine solutions relative to patient safety:

"The proposed Patient Safety Solutions address the issues of look-alike, sound-alike medications; correct patient identification; hand-over communications; wrong site, wrong patient surgery; use of concentrated electrolyte solutions; medication reconciliation; catheter and tubing misconnections; needle reuse and injection safety; and hand hygiene. The electronic Patient Safety Solution survey will be available online until February 16, 2007, at www.jcipatientsafety.org/survey."