Anemia drugs - emerging information and an FDA Alert!

Due to the results of studies recently published in the New England Journal of Medicine (as reported in the New York Times), the National Kidney Foundation will be convening a panel of experts to review whether or not current anemia treatment guidelines for kidney dialysis patients need to be updated. The studies published in the NEJM indicated that aggressive treatment of anemia in kidney patients resulted in more deaths than expected. From the NYT's article:

"The foundation’s panel will probably meet in January or early February and could release new treatment recommendations for public review a few weeks later, the foundation said.

The anemia panel consists of 15 nephrologists who meet under the auspices of the foundation, a private nonprofit group based in New York that provides financing for kidney researchers. The panel is one of several panels sponsored by the foundation that make recommendations about how to improve treatment for kidney patients.

But some scientists complain that Amgen has until now had too much influence on the creation of the foundation’s guidelines. The most recent version of the anemia guidelines, released earlier this year, encourages more aggressive treatment than the Food and Drug Administration recommends."

The FDA has, in fact, issued an alert on this topic. CME Providers who are in the process of planning CME activities on this topic need to read this alert!

Painful statistics for Americans

Earlier this month, the Centers for Disease Control (CDC) released the results of their annual health survey of Americans. In the CDC Press Release, lead study author Amy Bernstein states that the study focused on pain issues because "'the associated costs of pain are posing a great burden on the health care system, and because there are great disparities among different population groups in terms of who suffer from pain.'" Here are some of the survey study findings on pain:

More than one-quarter of adults interviewed said they had experienced low back pain in the past three months.

Fifteen percent of adults experienced migraine or severe headache in the past three months. Adults ages 18-44 were almost three times as likely as adults 65 and older to report migraines or severe headaches.

Reports of severe joint pain increased with age, and women reported severely painful joints more often than men (10 percent versus 7 percent).

Between the periods 1988-94 and 1999-2002, the percentage of adults who took a narcotic drug to alleviate pain in the past month rose from 3.2 percent to 4.2 percent.

Superbug touchdown

Methicillin-resistant staphylococcus aureus (MRSA) has historically been an issue in the hospital setting; of late, it has encroached upon athletic facilities. This tiny microbe recently tackled Cleveland Browns player, Brian Russell. A preseason MRSA infection required Russell to be hospitalized and infected some of his team mates as well:

"Stories like Russell’s are becoming more common. Staph infections, in varying and sometimes deadly forms, are being reported in greater numbers across Ohio and nationwide as more virulent and resilient strains are infecting high school, college and professional athletes.

Football players, wrestlers and even fencers have contracted methicillin-resistant staphylococcus aureus, or MRSA, a serious superbug once isolated to hospitals and health-care settings that has found its way into locker rooms, weight rooms and athletic training facilities. Despite widely available information about the dangers of skin infections, staph has continued spreading."

Military investing in medical simulation training centers

As reported in the New York Times, the U.S. Army is in the process of building 18 new medical simulation training centers worldwide in order to optimize combat medic training. One of these training centers is located at Fort Drum. The four simulation rooms at Fort Drum can be used to present medics-in-training with not only medical dilemmas but with "psychological, emotional and moral dilemmas".

For CME providers interested in learning more about medical simulation, please click here to go to the Society for Simulation in Healthcare's website. This society was formed in January 2004 and is comprised of educators and researchers interested in using a "variety of simulation techniques for education, testing, and research in health care". It now has over 1,000 members!

"Gratitude unlocks the fullness of life.

It turns what we have into enough, and more. It turns denial into acceptance, chaos into order, confusion into clarity.... It turns problems into gifts, failures into success, the unexpected into perfect timing, and mistakes into important events. Gratitude makes sense of our past, brings peace for today and creates a vision for tomorrow."

- Melody Beattie

I wish y'all a Very Happy Thanksgiving!

Moody agrees with antidepressant defense

According to a Forbes.com article, U.S. District Judge James Moody Jr. agreed with defendant Patrick Henry Stewart, a Tampa executive who embezzled $1.8 million dollars from his employer, that an antidepressant he was taking made him commit this crime. Instead of sentencing Stewart to the 3 1/2 years in prison recommended by prosecutors (as part of a plea agreement), Moody sentenced Stewart to home confinement for one year and five year's probation. Wonder how much Stewart's copay was on that prescription for the antidepressant...not enough, I would venture.

White Coat Trust and Confidence

We've all heard about "white coat hypertension," but what other effect might formally attired physicians have on patients? Well, a good one...in an article just published in the American Journal of Medicine, the authors found that patients (both female and male) "reported that they were significantly more willing to share their social, sexual, and psychological problems with the physician who is professionally dressed". For a more personal slant on this issue, see the New York Times essay "When Young Doctors Strut Too Much of Their Stuff".

ACME Webinar on New ACCME Accreditation Criteria

Just finished listening to this ACME webinar; Murray Kopelow, MD, did a really nice job in going over the new criteria. My personal opinion is that these new accreditation criteria are simply more explicit "guidance" in moving CME to where it should have always been. That said, the criteria are in effect beginning with November 2008 ACCME decisions, and CME providers need to start making changes now if they will be seeking Level III accreditation. For some CME providers, this will be a sea change. Bottom Line: ACCME has certainly thrown down the gauntlet and I, for one, am very pleased about the new criteria.

Will prescription pill prices be pushed down?

"Six Ways Congress Could Hurt Big Pharma" is a Forbes.com article which discusses the six bills that are in Congress that could negatively affect pharma profits. Besides bills dealing with Medicare and Medicaid reform, drug importation, and drug safety, there are bills on patent reform and the Prescription Drug User Fee Act reauthorization in Congress. And with the Democrats in the majority next year:

"Wall Street is getting worried. In a note to investors, analysts at Prudential Equity Group fret, 'Democrats are well positioned to force action on drug prices, and contrary to conventional wisdom, a [presidential] veto is not a sure thing.'"

More changes to come in CME Land, methinks.

Public service announcements in movie theaters?

Just read an article about how St. Joseph's Healthcare will be advertising in southwestern Ontario (Canada) movie theaters about their services. Which got me to thinking (always dangerous)...wouldn't it be wonderful if the U.S. movie entertainment industry stepped up and included public service announcements (PSAs) at movie theaters (and on DVDs). After all, if they charge $8 to see a movie (and charge $29.99 for the new DVD of that movie), it seems the least they could do is devote some time to PSAs (hint: y'all could make them very brief and entertaining).

Deaths from falls have risen for the elderly...

The Washington Post reports that recently released Centers for Disease Control (CDC) statistics indicate a 55% increase over the past 10 years in deaths from falls among the elderly. Death from falls is now the 14th leading cause of death in the United States. Speculation is that because people are living longer with chronic diseases that as they age they more likely to fall due to vision and/or hearing problems as well as lack of muscular strength.

The CDC has a Home Fall Prevention Checklist available online that older adults (and their loved ones) can utilize to make their homes safer.

Pay for performance (P4P) -- the UK experience

I've finally (and thankfully) gotten a chance to read the web article by Robert Galvin: "Pay-For-Performance: Too Much Of A Good Thing? A Conversation With Martin Roland." Health Affairs, September/October 2006; 25(5): w412-w419.

Galvin interviews Martin Roland, an advisor to the "world’s most ambitious P4P program," the United Kingdom’s Quality and Outcomes Framework (QOF). Roland discusses the unexpected results and findings of the QOF and offers some advice to the United States. Even though the UK and US health care delivery systems differ, it is still very worthwhile information. One important point that Roland makes is that exception reporting "was introduced on the basis that if you have some form of evidence-based guideline, nobody would ever suggest that it should be applied to all patients. So, for example, if you’ve got a diabetic who’s dying of cancer, you’re not going to try and get his cholesterol down."

I encourage all who are involved in CME to read this important article; check with your medical librarian to see if your institution already subscribes to Health Affairs (or this article can be purchased online for a nominal fee).

What a boost to primary care in the UK!

What are the most beneficial and cost-effective preventive services?

According to a study performed by the National Commission on Prevention Priorities they are:

1. Aspirin chemoprophylaxis
2. Childhood immunization series
3. Tobacco-use screening and brief intervention

See the full results of this study at the AAFP website "Practice Guidelines:
Partnership for Prevention Ranks Preventive Services." Be certain to check out Table 2 which depicts current utilization rates (the current tobacco-use screening and brief intervention national utilization rate is only 35%) and the additional quality-adjusted life years saved if utilization rates were at 90%.

Massachusetts to require docs to report HIV-infected patients

Beginning on January 1, 2007, physicians in Massachusetts are required to report the names of patients who test positive for HIV to the state Department of Public Health. Apparently the state will keep the data confidential. The Boston Globe article points out that the Federal Government "is making financial assistance for HIV patients contingent on the reporting of names."

New Alliance for CME Board Members!

Mark Schaffer, Greg Paulos, Winnie Brown, Damon Marquis were recently elected to the ACME's board of directors. Congratulations to all!

Mark and I have worked together in the past and he is so knowledgeable and such a nice person. I am so pleased that he was elected to the board as I know he will help lead the Alliance to a bright future. Here is his position statement (from the Alliance website):

"Position Statement: Over the years the Alliance has grown in membership. However, as often happens with a growing, nationally (internationally) based organization, only a small portion of the members take full advantage of what the organization has to offer. I believe it is the responsibility of the members of the Board to build on what previous Boards have done to make the Alliance more inclusive, welcoming, and, above all, of value to the entire membership. Issues the Alliance must address:

• Provide more educational opportunities, especially to those who can’t attend the annual conference.
• Help members address the challenges of developing more relevant content in varied formats.
• Help members recognize the similarities rather than differences of provider types; break the 'silo mentality'; foster concrete ways to partner and share strengths and even resources.
• Identify and secure other sources of revenue."

A great resource on medication safety!

I am very pleased to highlight the services of a colleague of mine, John M. Kessler, Pharm.D., B.C.P.S., who is President and Chief Clinical Officer of SecondStory Health, L.L.C. John and I worked together at Duke University and he continues to be a great resource for me that I am now sharing with y'all. John has more than 20 years of experience in medication systems design, adverse drug event reporting and errors analysis, and JCAHO accreditation standards. Additionally:

"He has chaired the United States Pharmacopoeia's Advisory Panel on Mediation Errors and he has served as an ex-officio Member on the National Coordinating Council for Medication Error Reporting and Prevention. He has consulted with healthcare organizations and regulatory authorities in the United States, South Africa, Brazil and the Middle East on medication safety.

He has experience in designing and implementing medication safety surveillance systems in large academic hospitals, small community hospitals and clinic environments. These surveillance systems have included:

• "triggers-based" concurrent monitoring system in a large academic hospital
• national drug information network to collect reports of adverse drug reactions
• voluntary reporting methods in hospitals and clinics
• observational methods and target-drug surveillance methods in hospitals
• computerized screening to identify adverse events in hospital diagnosis databases"

Please also keep John in mind if you are looking for an excellent speaker on medication safety!!

Unintentional medication error results in criminal charges

for a Wisconsin nurse. The medication error consisted of the nurse accidentally administering a bag of epidural analgesic intravenously rather than the intended penicillin. The 16-year-old patient, who was in labor, died as a result of this medication error. The nurse faces six years in jail and a $25,000 fine. This tragic accident and the nurse's subsequent criminal charges are discussed in a press release at the Institute of Safe Medication Practices website:

"While there is considerable pressure from the public and the legal system to blame and punish individuals who make fatal errors, filing criminal charges against a healthcare provider who is involved in a medication error is unquestionably egregious and may only serve to drive the reporting of errors underground. The belief that a medication error could lead to felony charges, steep fines, and a jail sentence can also have a chilling effect on the recruitment and retention of healthcare providers--particularly nurses, who are already in short supply."

100,000 nonaccident-related lower-limb amputations

are performed every year in the United States. Some 1.8 million Americans have undergone lower-limb amputations due to disease and medical conditions. From the New York Times article:

"Dr. Karel Bakker, a foot specialist who is a chairman of the International Diabetes Federation, believes that more effective foot care and patient education strategies would render up to 85 percent of these procedures unnecessary. Lower-limb ulcers are the most reliable harbingers of future amputation: according to a study published earlier this year in the journal Diabetes Care, nearly 9 in 10 nontraumatic foot and leg amputations come after the development of these infected sores, which can spread and quickly destroy surrounding tissue."

What a great QI project for CME providers!

San Diego CME Coordinators' Meeting

I just returned from having lunch with a great group of CME gals. The San Diego CME Coordinators' Meeting occurs on a quarterly basis and offers its "members" an opportunity to discuss what's new in CME and to share best practices. On the agenda today: ACCME New Criteria; CA AB487; and CA AB1195. I predict good things for this group! And I hope this gives y'all an idea about what you and your CME colleagues could be doing on a local level.

Three National Heart Attack Registries to be Combined

Three national heart attack registries are being combined into one registry, and the Duke Clinical Research Institute will play a leading role in the new registry which will be called the "National Cardiovascular Data Registry-Acute Coronary Treatment and Intervention Outcomes Network Registry." Duke cardiologists, Matthew Roe, M.D. and Eric Peterson, M.D. will serve as PIs for the new registry.

"Duke cardiologists were instrumental in the conception and implementation of one the three participating registries, known as CRUSADE. Started five years ago, this registry involves more than 500 hospitals in the United States and has collected clinical data on close to 200,000 patients.

The two other registries joining the collaboration are the National Registry of Myocardial Infarction, supported by Genentech, and the National Cardiovascular Data Registry, supported by American College of Cardiology Foundation.

Each of the three registries has collected detailed data on how patients with acute coronary syndrome were being treated in U.S. hospitals, with the goal helping hospitals stay current with the latest scientific findings."

KUDOS on the collaboration!

U.S. lagging in health care

Interesting article in the Washington Post regarding a study just published in Health Affairs. This study found that the U.S. is behind other countries on: 1) after-hours health care; 2) adoption of electronic medical records; and 3) investment in primary care systems.

"'Although the U.S. pays more for health care than any other country, we are under-investing in our primary care system,' Karen Davis, president of the Commonwealth Fund, the foundation that sponsored the survey, said in a statement. 'Other countries have made high-quality primary care a priority by putting into place the financial and technical systems that support access to, and delivery of, such care.'"

Piloting the way to patient safety

While some might say that delivering health care is so much more complex than flying planes, there are things that health care providers can learn from the airline industry. It seems a growing number of hospital administrators are bringing in aviation experts so that their medical staff members and employees can learn about prevention strategies. From the New York Times article "What Pilots Can Teach Hospitals About Patient Safety":

"'We’re where the airline industry was 30 years ago' when a series of fatal mistakes increased scrutiny and provoked change, said Dr. Stephen B. Smith, chief medical officer at the Nebraska Medical Center in Omaha, the teaching hospital for the University of Nebraska.

It is well established that, like airplane crashes, the majority of adverse events in health care are the result of human error, particularly failures in communication, leadership and decision-making.

'The culture in the operating room has always been the surgeon as the captain at the controls with a crew of anesthesiologists, nurses and techs hinting at problems and hoping they will be addressed,' Dr. Smith said. 'We need to change the culture so communication is more organized, regimented and collaborative, like what you find now in the cockpit of an airplane.'"