Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period April - June 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) April - June 2010

Product Name: Active Ingredient (Trade) or Product Class
Potential Signal of a Serious Risk / New Safety Information
Additional Information
(as of July 15, 2010)

Clindamycin injection (Cleocin)

Overdose due to labeling confusion/medication errors

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Dronedarone hydrochloride
(Multaq)

Torsade de Pointes

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Etonogestrel implant (Implanon)

Convulsions

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Everolimus
(Afinitor)

Hepatitis B reactivation

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Febuxostat
(Uloric)

Hypersensitivity

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Ferumoxytol injection (Feraheme)

Serious cardiac disorders

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

GnRH Agonists
(Androgen Deprivation Therapy)

Hyperinsulinemia, Arterial thrombosis

FDA Drug Safety Communication
FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Lanthanum carbonate (Fosrenol)

Intestinal obstruction

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Omeprazole products

Hypomagnesemia

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Simvastatin
(Zocor)

Muscle injury with 80mg dose

FDA Drug Safety Communication

FDA Patient Safety News, June 2010

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Saquinavir mesylate (Invirase)

Prolonged QT and PR Syndromes

FDA Drug Safety Communication
FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Tapentadol hydrochloride (Nucynta)

Convulsions, Hallucinations, Serotonin syndrome

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Tetracycline products

Stevens Johnson Syndrome,
Toxic Epidermal Necrolysis,
Erythema Multiforme

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Trastuzumab
(Herceptin)

Neonatal pulmonary hypoplasia

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Notification - ENURGENT: Voluntary Market Withdrawal
      Initiated by :  Octapharma USA Inc.
      Event Id :  143
      Event Date :  08-20-2010
      Therapy Octagam®
            NDC Number Lot Number Size Packaging Expiration Date
            67467 0843 03A002B84315 GMVial01-01-2012
            67467 0843 03A008C84315 GMVial02-28-2012
            67467 0843 04A009A843110 GMVial03-03-2012
            67467 0843 04A009C843110 GMVial03-04-2012
            67467 0843 04A010A843110 GMVial03-10-2012
            67467 0843 04A010C843110 GMVial03-11-2012
            67467 0843 04A011B843110 GMVial03-17-2012
            67467 0843 04A011C843110 GMVial03-18-2012
            67467 0843 04A012B843110 GMVial03-24-2012
            67467 0843 04A012C843110 GMVial03-25-2012
            67467 0843 04A012D843110 GMVial03-25-2012
            67467 0843 04A012E843110 GMVial03-26-2012
            67467 0843 03A013A84315 GMVial03-31-2012
            67467 0843 03A013B84315 GMVial03-31-2012
            67467 0843 04A013C843110 GMVial04-01-2012
            67467 0843 03A014A84315 GMVial04-07-2012
            67467 0843 04A014B843110 GMVial04-07-2012
            67467 0843 04A014C843110 GMVial04-08-2012
            67467 0843 04A014D843110 GMVial04-08-2012
            67467 0843 04A015A843110 GMVial04-14-2012
            67467 0843 04A015B843110 GMVial04-15-2012
            67467 0843 04A015C843110 GMVial04-15-2012
            67467 0843 04A016B843110 GMVial04-22-2012
            67467 0843 04A016C843110 GMVial04-23-2012
            67467 0843 04A016D843110 GMVial04-22-2012
            68209 0843 04C011C843110 GMVial03-18-2012
            68209 0843 04C013C843110 GMVial04-01-2012
            68209 0843 04C025A843110 GMVial06-23-2012
            67467 0843 04A004A843110 GMVial01-27-2012
            67467 0843 04A004B843110 GMVial01-28-2012
            67467 0843 04A008B843110 GMVial02-25-2012

      Reason: This voluntary withdrawal is being conducted as a precautionary
      measure. In the interest of patient safety, Octapharma USA Inc. has
      initiated a voluntary market withdrawal of selected lots of octagam®
      [immune globulin intravenous (human)] 5% Liquid Preparation] as a result
      of an increased number of reported thromboembolic events, some of which
      were serious.

      Action: 1) Please check all product labels against the list of affected lot
      numbers.
      2) Do not take this product. Return any product from the withdrawn lots to
      the point of purchase or to your healthcare provider.
      3) Contact your physician if you have medical questions.

      Other Information: If you need assistance, please call Octapharma USA
      Medical Affairs Department at 360 990 4318.

Immune system gene linked with Parkinson’s: study

Sunday, August 15, 2010

By Julie Steenhuysen

CHICAGO (Reuters) - A gene linked with the immune system may play a role in developing Parkinson’s disease, researchers said on Sunday, marking a possible advance in the search for effective treatments.

They said a gene in the human leukocyte antigen region or HLA — which contains a large number of genes related to immune system function — was strongly linked with Parkinson’s disease.

“That means the immune system probably plays a role in your body developing Parkinson’s disease,” said Dr. Cyrus Zabetian of the University of Washington and Veteran’s Administration Puget Sound Health Care System, whose study appears in the journal Nature Genetics.

Zabetian said there had been hints that the immune system may be linked to Parkinson’s disease, a neurodegenerative disease that affects 1 to 2 percent of people over age 65.

“This is the best evidence we’ve seen so far,” Zabetian said in a telephone interview.

The finding came from a large, long-term study of more than 2,000 Parkinson’s disease patients and 2,000 healthy volunteers from clinics in Oregon, Washington, New York and Georgia.

Parkinson’s sufferers have tremors, sluggish movement, muscle stiffness and difficulty with balance.

Researchers looked at clinical, genetic and environmental factors that might contribute to the development and progression of Parkinson’s disease and its complications.

“We found strong evidence that a gene within the HLA region is associated with Parkinson’s disease,” Zabetian said.

HLA genes play an important role in helping the body discern between foreign invaders and the body’s own tissues.

“We don’t know specifically which gene because there is a cluster of genes in that region, but it is the first really strong link that the immune system plays a role,” he said.

That may mean infections, inflammation or an auto-immune response play some role in the development of Parkinson’s disease, Zabetian said.

“What this allows us to do is to hone in on the immune system,” he said.

Although current medical treatments may improve symptoms, none can slow or halt the progression of the disease.

The study was funded in part by the National Institute of Neurological Disorders and Stroke, one of the National Institutes of Health.

(Editing by Vicki Allen)

Reuters Health

H3N2 flu outbreaks, cases trigger CDC alert

Robert Roos News Editor

Aug 5, 2010 (CIDRAP News) – The Centers for Disease Control and Prevention (CDC) is urging healthcare providers to be alert for influenza cases, following the reporting of two small outbreaks of influenza A/H3N2 in Iowa and scattered H3N2 cases in 11 other states.

Noting that sporadic cases and localized outbreaks of flu are detected every summer, the CDC said clinicians should consider flu as a possible diagnosis in patients with acute respiratory illnesses, including pneumonia.

In an e-mailed health advisory issued last night, the CDC said the number of reported H3N2 viruses in late June and July increased slightly over previous months. In early July, two small outbreaks confirmed by reverse transcriptase–polymerase chain reaction (RT-PCR) were confirmed in non-neighboring counties in eastern Iowa, the notice added.

The first outbreak included 4 of 13 members of a college sports team who became ill, the CDC said. The second one included 9 of 12 children in a child-care setting and one parent. Two patients in the first outbreak and one in the second have tested positive by PCR, and samples have been sent to the CDC for further analysis.

None of the patients had traveled recently, and there were no epidemiologic links between the two outbreaks, the CDC said.

However, a Jul 30 epidemiologic update from the Iowa Department of Public Health (IDPH) said several patients in the two outbreaks have “connections to travel outside of Iowa.” An earlier IDPH update, dated Jul 16, mentions two H3 flu cases in Johnson County.

In addition to the Iowa outbreaks, between Jun 20 and Jul 23 the CDC received H3-positive specimens from 11 other states and a “smaller number of sporadic samples” that tested positive for the 2009 H1N1 and influenza B viruses, the CDC notice said.

The CDC did not list the states that have reported cases, other than Iowa. However, the IDPH updates mentioned that H3 cases have been reported recently in Minnesota, Arkansas, Wisconsin, Pennsylvania, and Hawaii.

On the basis of hemagglutinin gene sequencing of four isolates so far, the CDC said, the viruses are expected to be similar to A/Perth/16/2009-like H3N2 viruses, a strain that’s included in this year’s seasonal flu vaccine.

“Perth-like H3N2 viruses were first identified in early 2009, but have not yet circulated widely in the United States,” the notice stated. Previous flu vaccines did not include this strain, so last year’s vaccine would not be likely to provide much protection against it, it said.

The CDC alert advises that treatment decisions should not be based on negative rapid flu test results, since rapid tests have only moderate sensitivity and also can yield false-positives. If laboratory confirmation is wanted, clinicians should order RT-PCR or viral culture.

“Clinicians should use empirical treatment with influenza antiviral medications for persons hospitalized with suspected influenza, and for suspected influenza infection of any severity in high-risk individuals, regardless of influenza immunization status,” the CDC said.

H3N2 viruses have been circulating since they emerged in the pandemic of 1968-69. But last winter they were largely crowded out by the pandemic H1N1 virus in the United States. Flu experts say that flu seasons in which H3N2 viruses predominate tend to be more severe than those in which seasonal H1N1 or type B viruses are dominant.

See also:

IDPH page with access to Jul 30 and Jul 16 epidemiologic updates
http://www.idph.state.ia.us/IdphArchive/Archive.aspx?channel=EpiUpdate

Advice from Harvard Health about Caregiving

Survival tips for current and future caregivers

One day you may find that someone you care about — a spouse, parent, relative, or close friend — needs help negotiating the daily tasks of life. Perhaps that day has already come. Close to 49 million informal or family caregivers offer assistance of all sorts to adults in America, according to the National Alliance for Caregiving and AARP. Their efforts are vital to the lives of people struggling with illness, disability, or the changes that often accompany aging.

The spectrum of tasks that unpaid caregivers undertake is truly vast. Some, such as grocery shopping and cooking, are familiar to us all. Giving injections, changing bandages, calming an agitated parent suffering from Alzheimer’s disease, or helping a disabled partner get from the bed to the bathroom can be far more daunting. But through countless unheralded contributions like these, caregivers allow millions of Americans to continue to live as independently as possible.

Talking with your loved one

Discussing needs can be a prickly business. It may be easy for you to imagine what sort of help is necessary, but much harder to discuss it openly or come to an agreement with the person who needs care.

Ask the person in need of care to spell out what he or she believes would help. One way to open a conversation is to say: “I’ve wondered if you’re having any trouble with _______.” Or, “I’ve noticed it is getting harder for you to _______.” If offers of help are flatly declined, you might call in a second opinion about the need for assistance. Try talking to the person’s doctor or trusted relatives or friends. Their opinions may carry more weight than your own. Some doctors, particularly geriatricians, may be willing to schedule and attend a family conference to talk about what is needed. Geriatric care managers or social workers can also help facilitate these kinds of discussions and present a range of options.

Encourage forethought

Whenever possible, it helps enormously to plan ahead for certain types of assistance, such as good nursing home care and insurance coverage. You might start a conversation by saying: “I read about Medicaid planning in the news today. Do you know about this?”

Be sensitive

In many families, parents never talk to their children — even after they become adults — about finances or health problems. And it is hard to ask sensitive questions of a relative, spouse, or partner who already feels pressured from illness. Raising concerns about your own financial future can make it easier for you to ask your parent about his or her finances. The same tactic may work well for discussing end-of-life decisions. You may find that the person wants to acknowledge these issues. It can be a relief to talk frankly about troubling topics and share concerns rather than hiding them.

Honest talk for tough decisions

Certain topics — for instance, that an individual shouldn’t be driving or that it’s getting too difficult to continue caring for a person at home — are painful to discuss for everyone concerned. Even so, telling white lies or making promises that are impossible to keep can come back to haunt you.

No one ever wants to go to a nursing home, for example, but instead of pledging that this will never happen, it may be best to promise only that you will try hard to work out other solutions for as long as possible. If you know a nursing home is the best long-term option, it doesn’t help to suggest that such a move is just for a few weeks. When those weeks are over, the reckoning and sense of betrayal are impossible to sidestep. It’s better to acknowledge that these are hard, sad decisions replete with many layers of loss.

You might put these sentiments into your own words: “I know it’s very hard to even think about moving to a nursing home. But we can’t supply all the care you need anymore. I worry about you constantly, especially when I’m not available. I’ve tried really hard, but I can’t keep everything going. We need to think about finding a place where you’ll be safe and well cared-for all the time.”

If appropriate, you might mention concerns about your own health and well-being or worries about what might happen if you become ill or unable to offer enough care. A single conversation is rarely sufficient. Let the person you are caring for grieve the loss. Moving toward a solution is likely to take time and several discussions.

One thing to keep in mind in situations where judgments might differ is that people are often willing to assume a level of risk to their safety or well-being in exchange for autonomy and personal choice. If a loved one chooses to live in a situation that seems too risky to you, you might need the help of a doctor to determine decision-making capacity. If your loved one can fully understand the consequences of his or her decisions then you must abide by them, whether you agree with them or not.

I hope you find this blog as interesting as I have.

This particular ‘musing’ is of interest to PIDD patients.

I left Dr Rob’s info in here just in case you would like to subscribe to his blog, AS WELL as to MY BLOG:)

A Letter to Patients with Chronic Illness

By: Dr. Rob  |  July 20, 2010

Note: The following post from my blog had an incredible response in the chronic pain community and across the web.  Clearly this is a very important issue and this letter touched a nerve that has largely been ignored.

Dear Patients:

You have it very hard, much harder than most people understand.  Having sat for 16 years listening to the stories, seeing the tiredness in your eyes, hearing you try to describe the indescribable, I have come to understand that I too can’t understand what your lives are like.  How do you answer the question, “how do you feel?” when you’ve forgotten what “normal” feels like?  How do you deal with all of the people who think you are exaggerating your pain, your emotions, your fatigue?  How do you decide when to believe them or when to trust your own body?  How do you cope with living a life that won’t let you forget about your frailty, your limits, your mortality?

I can’t imagine.

But I do bring something to the table that you may not know.  I do have information that you can’t really understand because of your unique perspective, your battered world.  There is something that you need to understand that, while it won’t undo your pain, make your fatigue go away, or lift your emotions, it will help you.  It’s information without which you bring yourself more pain than you need suffer; it’s a truth that is a key to getting the help you need much easier than you have in the past.  It may not seem important, but trust me, it is.

You scare doctors.

No, I am not talking about the fear of disease, pain, or death.  I am not talking about doctors being afraid of the limits of their knowledge.  I am talking about your understanding of a fact that everyone else seems to miss, a fact that many doctors hide from: we are normal, fallible people who happen to doctor for a job.  We are not special.  In fact, many of us are very insecure, wanting to feel the affirmation of people who get better, hearing the praise of those we help.  We want to cure disease, to save lives, to be the helping hand, the right person in the right place at the right time.

But chronic unsolvable disease stands square in our way.  You don’t get better, and it makes many of us frustrated, and it makes some of us mad at you.  We don’t want to face things we can’t fix because it shows our limits.  We want the miraculous, and you deny us that chance.

And since this is the perspective you have when you see doctors, your view of them is quite different.  You see us getting frustrated.  You see us when we feel like giving up.  When we take care of you, we have to leave behind the illusion of control, of power over disease.  We get angry, feel insecure, and want to move on to a patient who we can fix, save, or impress.  You are the rock that proves how easily the ship can be sunk.  So your view of doctors is quite different.

Then there is the fact that you also possess something that is usually our domain: knowledge.  You know more about your disease than many of us do – most of us do.  Your MS, rheumatoid arthritis, end-stage kidney disease, Cushing’s disease, bipolar disorder, chronic pain disorder, brittle diabetes, or disabling psychiatric disorder – your defining pain –  is something most of us don’t regularly encounter.  It’s something most of us try to avoid.  So you possess deep understanding of something that many doctors don’t possess.  Even doctors who specialize in your disorder don’t share the kind of knowledge you can only get through living with a disease.  It’s like a parent’s knowledge of their child versus that of a pediatrician.  They may have breadth of knowledge, but you have depth of knowledge that no doctor can possess.

So when you approach a doctor – especially one you’ve never met before – you come with a knowledge of your disease that they don’t have, and a knowledge of the doctor’s limitations that few other patients have.  You see why you scare doctors?  It’s not your fault that you do, but ignoring this fact will limit the help you can only get from them.  I know this because, just like you know your disease better than any doctor, I know what being a doctor feels like more than any patient could ever understand.  You encounter doctors intermittently (more than you wish, perhaps); I live as a doctor continuously.

So let me be so bold as to give you advice on dealing with doctors.  There are some things you can do to make things easier, and others that can sabotage any hope of a good relationship:

1. Don’t come on too strong – yes, you have to advocate for yourself, but remember that doctors are used to being in control.  All of the other patients come into the room with immediate respect, but your understanding has torn down the doctor-god illusion.  That’s a good thing in the long-run, but few doctors want to be greeted with that reality from the start.  Your goal with any doctor is to build a partnership of trust that goes both ways, and coming on too strong at the start can hurt your chances of ever having that.
2. Show respect – I say this one carefully, because there are certainly some doctors who don’t treat patients with respect – especially ones like you with chronic disease.  These doctors should be avoided.  But most of us are not like that; we really want to help people and try to treat them well.  But we have worked very hard to earn our position; it was not bestowed by fiat or family tree.  Just as you want to be listened to, so do we.
3. Keep your eggs in only a few baskets – find a good primary care doctor and a couple of specialists you trust.  Don’t expect a new doctor to figure things out quickly.  It takes me years of repeated visits to really understand many of my chronic disease patients.  The best care happens when a doctor understands the patient and the patient understands the doctor.  This can only happen over time.  Heck, I struggle even seeing the chronically sick patients for other doctors in my practice.  There is something very powerful in having understanding built over time.
4. Use the ER only when absolutely needed – Emergency Room physicians will always struggle with you.  Just expect that.  Their job is to decide if you need to be hospitalized, if you need emergency treatment, or if you can go home.  They might not fix your pain, and certainly won’t try to fully understand you.  That’s not their job.  They went into their specialty to fix problems quickly and move on, not manage chronic disease.  The same goes for any doctor you see for a short time: they will try to get done with you as quickly as possible.
5. Don’t avoid doctors – one of the most frustrating things for me is when a complicated patient comes in after a long absence with a huge list of problems they want me to address.  I can’t work that way, and I don’t think many doctors can.  Each visit should address only a few problems at a time, otherwise things get confused and more mistakes are made.  It’s OK to keep a list of your own problems so things don’t get left out – I actually like getting those lists, as long as people don’t expect me to handle all of the problems.  It helps me to prioritize with them.
6. Don’t put up with the jerks – unless you have no choice (in the ER, for example), you should keep looking until you find the right doctor(s) for you.  Some docs are not cut out for chronic disease, while some of us like the long-term relationship.  Don’t feel you have to put up with docs who don’t listen or minimize your problems.  At the minimum, you should be able to find a doctor who doesn’t totally suck.
7. Forgive us – Sometimes I forget about important things in my patients’ lives.  Sometimes I don’t know you’ve had surgery or that your sister comes to see me as well.  Sometimes I avoid people because I don’t want to admit my limitations.  Be patient with me – I usually know when I’ve messed up, and if you know me well I don’t mind being reminded.  Well, maybe I mind it a little.

You know better than anyone that we docs are just people – with all the stupidity, inconsistency, and fallibility that goes with that – who happen to doctor for a living.  I hope this helps, and I really hope you get the help you need.  It does suck that you have your problem; I just hope this perhaps decreases that suckishness a little bit.

Sincerely,

Dr. Rob

Tdap Vaccine Protects Against Pertussis During Outbreak

Karla Gale, MS

July 9, 2010 — The Tdap vaccine — a tetanus, reduced-dose diphtheria, and acellular pertussis booster — effectively protected adolescents during a pertussis outbreak in the U.S. Virgin Islands, investigators reported online June 25th in Clinical Infectious Diseases.

Tdap’s licensure in 2005 was based on serological surrogate end points rather than direct vaccine efficacy data. In this study, the first published evaluation in an outbreak setting, Tdap was 65.6% effective.

The outbreak occurred in the autumn of 2007 at a nursery through 12th grade school on St. Croix. With 51 confirmed or probable cases among 499 students, the attack rate was 10%. Coughs lasted up to four months or more, with a median duration of 38 days.

According to senior author Dr. Stacey W. Martin, from the U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues, all but three cases occurred in grades six through 12, with an overall attack rate in those classes of 17%. The highest incidence was in the 10th grade (38%).

Among students age 11 and older, overall Tdap coverage was 12%. There were two confirmed or probable cases among 33 vaccinated students (6.1%) and 41 among 233 not vaccinated (17.6%, relative risk 2.9). The vaccine’s effectiveness was not statistically significant (p = 0.092) due to limited sample size.

Local authorities collected nasopharyngeal aspirates or swab samples for culture and for pertussis polymerase chain reaction (PCR) testing from students whose cough had started no more than 14 days earlier. They also collected blood samples from students with any duration of cough. During the convalescence phase in winter 2008, nasopharyngeal specimens were again collected from kids with cough, and all students age 11 and over were offered serological testing regardless of cough history.

In confirmed cases, Bordetella pertussis was isolated in culture or patients had positive PCR or serological test results. Clinical cases (cough for at least 14 days along with whoop, post-tussive vomiting and/or paroxysmal cough) that were not laboratory-confirmed were classified as probable.

Because the Advisory Committee on Immunization Practices recommends Tdap vaccination only for adolescents and adults up to age 65, the research team limited its vaccine efficacy analyses to the 287 students age 11 and older.

Among 162 students who provided clinical specimens, six had culture-confirmed cases. These six also had the only positive results on PCR and convalescent serology.

The authors report that geometric mean concentrations (GMC) of anti-pertussis IgG varied in the serum samples obtained in the convalescent period, from 107.2 ELISA Units/mL in 40 patients with confirmed or probable cases, to 20.2 EU/mL in 45 students with a history of cough not meeting the case definition, and 29.4 EU/mL in 72 students with no history of cough (p < 0.001 comparing cases with noncases).

They also note that only 26 of 40 case patients had positive convalescent serological test results, and one had indeterminate results.

On the other hand, 12 of 72 noncoughing students also had positive serological test results, indicating “evidence of asymptomatic infection and the potential for unrecognized transmission.”

The investigators also point out that serology results identified 20 patients who didn’t present for testing until they’d been coughing for more than two weeks. These students didn’t provide nasopharyngeal specimens, but if they had, the tests would likely have been negative because of the timing. Given the usefulness of serology in these cases, the authors recommend that the Council of State and Territorial Epidemiologists include serological testing in its case definition.

“Higher Tdap coverage rates are needed to minimize the negative impacts of waning immunity, imperfect (vaccine effectiveness) and high secondary transmission rates,” the research team concludes.

Clin Infect Dis. 2010;51:315-321.

Reuters Health Information 2010. © 2010 Reuters Ltd.

Best Hospitals 2010-11: The Honor Roll

The new U.S. News rankings showcase 14 hospitals with high scores in six or more specialties.

By Avery Comarow, U.S. News & World Report

Find more

• Photo Gallery: A Tour of America’s Best Hospitals
• Search All Best Hospitals
• See the Best Children’s Hospitals Rankings

It’s no secret that all hospitals are not equal. The special quality shared by the 152 that made it into the new 2010-11 Best Hospitals rankings (out of nearly 5,000 that were considered), and even more so by the 14 in this year’s Honor Roll, is their ability to take on and meet the most difficult challenges. Their operating rooms showcase delicate, demanding procedures—excising a cancerous portion of a pancreas without destroying the rest of the fragile organ, say, or restoring function to an arthritis-ravaged hand through a creative blend of fusing joints and splicing tendons. They are referral centers for ill patients with multiple risks—advanced age plus heart failure plus diabetes, perhaps.

• See America’s Best Hospitals and search for one near you.

Patients at these centers are not free from hospital-based infections or immune from getting the wrong drugs or becoming victims of other medical errors. No matter how skilled or deep their expertise, even “best hospitals” don’t do everything right. But when the stakes are high, calling for unusual capabilities, they are hospitals that can save lives that might otherwise be lost or preserve quality of life that might otherwise be sacrificed. That is why U.S. News has published the Best Hospitals rankings for 21 years: to help guide patients who need high-stakes care because of the complexity or difficulty of their condition or procedure. For 2010-11 we analyzed 4,852 hospitals, virtually every one in the United States, in 16 specialties from cancer and heart disease to respiratory disorders and urology. Only 152 centers appear in even one of the 16 specialty rankings. Fourteen ultra-elite Honor Roll hospitals had very high scores in six or more specialties.

In 12 of the 16 specialties, the quality of hospital care can determine life or death. Therefore the largest part of each hospital’s score in those 12 specialties came from death rates and other hard data on patient safety, volume, and various care-related factors such as nursing and patient services. The rest of the score was derived from a reputational survey of specialists. The 50 highest scorers were ranked. Scores and complete data for another 1,740 unranked hospitals are also available. In the four other specialties—ophthalmology, psychiatry, rehabilitation, and rheumatology—hospitals were ranked on reputation alone. The number of deaths in these specialties is so low that mortality data and certain other categories of data are not relevant factors.

A detailed description of the analysis in the 12 specialties is available. In brief, death rate, care-related factors, and patient safety added up to slightly more than two-thirds of each hospital’s score. The reputation portion of the score used responses from nearly 10,000 physicians, who were surveyed in 2008, 2009, and 2010 and asked to name five hospitals they consider among the best in their specialty for difficult cases, ignoring cost or location.

The Honor Roll requirements were so stiff that 99.7 percent of all centers in the nation were excluded. A hospital had to be ranked in at least six specialties, but ranking alone was insufficient for inclusion. It also had to have an extremely high score (in statisticians’ terms, at least 3 standard deviations above the mean). That earned 1 point per specialty. Reaching the top of the Honor Roll called for even higher scores (4 or more standard deviations above the mean), earning 2 points, in far more specialties. The highest-ranked hospitals on the Honor Roll, which is ordered by points, had high scores in 15 of the 16 specialty rankings. Johns Hopkins stands at No. 1—as it has for the last 20 years.

Rank

1

Johns Hopkins Hospital, Baltimore

2

Mayo Clinic, Rochester, Minn.

3

Massachusetts General Hospital, Boston

4

Cleveland Clinic

5

Ronald Reagan UCLA Medical Center, Los Angeles

6

New York-Presbyterian University Hospital of Columbia and Cornell

7

University of California, San Francisco Medical Center

8

Barnes-Jewish Hospital/Washington University, St. Louis

9

Hospital of the University of Pennsylvania, Philadelphia

10

Duke University Medical Center, Durham, N.C.

11

Brigham and Women’s Hospital, Boston

12

University of Washington Medical Center, Seattle

13

UPMC-University of Pittsburgh Medical Center

14

University of Michigan Hospitals and Health Centers, Ann Arbor

Hi, I’m Stacey Martin.

I’d like to talk about Tdap vaccine recommendations and the opportunity we have to protect patients from pertussis.

Despite the use of pertussis-containing childhood vaccines, cases of pertussis have been on the rise in many communities nationwide, with an increasing burden of disease reported among adolescents and adults. In 2008 there were over 13,000 cases and 20 deaths reported to CDC.

In 2005, the Advisory Committee on Immunization Practices, or ACIP, recommended a dose of a combination tetanus, diphtheria and pertussis vaccine — or Tdap — for use in 11 through 64 year olds.

There are currently 2 licensed products that can be used. Because immunity from childhood pertussis vaccination wanes over time, this booster shot for adolescents and adults is essential. Boosting reduces the risk of contracting pertussis and can decrease severity of disease. Most importantly, vaccinating adolescents and adults can help prevent pertussis transmission to infants too young to be vaccinated. This youngest age group is most vulnerable to severe disease and death from pertussis.

Even though Tdap has been recommended since 2005, coverage rates are not as high as we’d like them to be. Among adolescents who are 13 though 17 years of age, coverage was estimated at 40% in 2008. Among adults, it was less than 6%.

Here are the key recommendations for using Tdap:

• Among adolescents who have completed their childhood pertussis vaccinations, Tdap is routinely recommended as a single dose with preferred administration at 11 to 12 years of age.
• If your adolescent patient was not fully vaccinated for pertussis as a child, check the ACIP recommendations and catch-up schedule to determine what’s indicated. Those resources are linked below
• Any adult 19 through 64 years old who has not received a dose of Tdap should get one. This can replace 1 of the 10-year Td booster doses.

However, it’s not necessary to wait the typical 10 years to get the adult dose of Tdap after the last dose of Td. An interval as short as 2 years from the last Td is suggested to reduce likelihood of increased reactogenicity.

Even shorter intervals may be appropriate if your patient is at high risk for contracting pertussis or has close contact with infants, or in situations where you might not get a chance to vaccinate the patient again. Providers should know that shorter intervals are not contraindicated and accumulating data reinforce safety of the vaccine. Furthermore, there are no concerns about immunogenicity with this decreased interval between Td and Tdap administration.

To help protect infants too young to be vaccinated, women should ideally receive Tdap before becoming pregnant. If a pregnant woman is at increased risk for contracting pertussis, such as during a community outbreak, you may want to consider Tdap during pregnancy since it’s not contraindicated. New moms who have not received Tdap should routinely receive a dose immediately postpartum, before leaving the hospital or birthing center.

In most cases, pertussis in infants is acquired from a family member. Imagine how devastating it would be for a mom to give her baby pertussis. Keep in mind that Tdap is not just for postpartum moms, it’s for all family members and caregivers of the infant.

Also, healthcare providers who have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received it.

Check out the resources on this page for more information.

And remember, think Tdap instead of Td. Thank you.

Six ways you can help your immune system

If you didn’t have a functioning immune system, simply brushing your teeth would introduce enough harmful bacteria into your bloodstream to kill you. Luckily, your immune system protects you from these common, everyday bacteria.

Sight unseen, your immune system cells are constantly gobbling up bacteria and blocking viruses from invading your cells. Like your heartbeat or your digestion, the immune response is a function you don’t control. But there are plenty of things you can do to lend a helping hand.

1. Good hygiene. The first line of defense is to keep germs at bay by following good personal hygiene habits. Stop infection before it begins and avoid spreading it to others with these easy measures:

• Wash your hands with soap and water before preparing food and after using the bathroom.

• Cover your mouth and nose with a tissue when you sneeze or cough, or cough into your elbow rather than your hand.
• Wash and bandage all cuts. Any serious cut, or animal or human bite, should be examined by a doctor.
• Do not pick at healing wounds or blemishes or squeeze pimples. Doing so allows germs to enter.

2. Vaccination. Many serious infections can be prevented by immunization. While some common side effects, such as a sore arm or low fever, may occur, vaccines are generally safe and effective. Consult your health care provider regarding your immunization status. In general:

• Children should receive the recommended childhood vaccinations.
• Adults should make sure their vaccinations are up to date.
• Travelers should get any necessary additional immunizations.

3. Food safety. Although most cases of food poisoning are not life-threatening, a few may lead to serious medical conditions, including kidney failure and meningitis. You can prevent most cases of food poisoning in your household by preparing and storing your foods safely. The following precautions will help kill germs that are present in the food you buy and help you avoid introducing new bugs into your food at home:

• Wash your hands with soap and water before and after each time you handle a raw food.
• Rinse all meat, poultry, and fish under running water before cooking. Rinse all fruits and vegetables under running water before cooking or serving them.
• Separate raw foods and cooked foods, and never use the same utensils or cutting boards with cooked meat that were used with raw meat.
• Cook foods thoroughly, using a meat thermometer to ensure that whole poultry is cooked to 180° F, roasts and steaks to 145° F, and ground meats to 160° F. Cook fish until it is opaque.
• Defrost foods only in the refrigerator or in the microwave.

4. Healthy travel. If you are planning a trip, ask your doctor if you need any immunizations. Discuss your travel plans with your physician at least three months before you leave. In addition:

• If you are traveling to an area where insect-borne disease is present, take and use an insect repellent containing DEET. In many tropical regions, mosquitoes can carry malaria, dengue, yellow fever, Japanese encephalitis, and many other serious infections. In many parts of the United States, ticks in meadows and woods carry Lyme disease or other diseases.
• Avoid getting any unnecessary shots, immunizations, or even tattoos abroad. Needles and syringes (even the disposable ones) are reused in some parts of the world.

5. Clean water. Some countries do not follow stringent standards of water safety. If you have any doubt about the food or water while traveling, take these precautions:

• Do not consume ice while traveling. Freezing does not kill all infectious microbes.
• Drink only bottled drinks — such as soft drinks or bottled water — that have secure caps. Be aware that some fruit juices contain impure local water.

• Boil all tap water before drinking or drink only bottled water; use bottled or boiled water to brush your teeth.
• Do not eat uncooked vegetables, including lettuce; do not eat fresh, uncooked fruit you have not peeled yourself.
• Do not consume dairy products (milk may not be pasteurized).
• No matter where you are, avoid drinking untreated water from lakes and streams, which can contain disease-causing organisms from human or animal waste. If you must drink the water, bring it to a rolling boil for one minute to reduce the chance of infection.

6. Safe sex. The only sure way to prevent sexually transmitted diseases (STDs) is to not have sexual intercourse or other sexual contact. But the next best choice is to follow these safer sex guidelines:

• Engage in sexual intercourse only with one partner who has been tested and who is having sex only with you.
• Use a latex or polyurethane condom or a female condom every time you have sex.
• For oral sex, use a latex or polyurethane male condom or a female condom.
• For anal sex, use a latex or polyurethane male condom.