DC Medical Malpractice & Patient Safety Blog

A group of patient safety advocates has put together two outstanding web sites chock full of information about how to navigate the health care system safely for you and your loved ones.

The Empowered Patient Coalition (click here for the web site) is educating patients on how to become informed and involved in their own health care -- which makes for better, safer outcomes. One of their first projects is a blueprint for managing a stay in the hospital. The web site has many more valuable resources, including this directory of non-profit patient safety groups, helpful books and other resources. Many of these groups were started by lay people who had terrible experiences with medical malpractice in the health care system and want to make a difference by helping others to avoid injury.

A related web site has a broader directory of patient safety advocates who serve the public. The directory includes patient safety professionals, radio shows, blogs and other links. Click here for the link. Mothers Against Medical Error (MAME), through its founder Helen Haskell, put together this directory.

The use of rapid response teams could be masking underlying patient care problems in hospitals, according to a patient safety expert writing in the Journal of the American Medical Association.

Rapid Response Teams (RRTs) are teams of doctors and nurses assigned to provide rapid bedside care for patients who are in critical condition.

The co-author of the article, Peter Pronovost, MD, PhD, a professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, says hospitals should focus more on why patients are deteriorating in the first place, instead of waiting until they crash.

Pronovost argues that the use of rapid response teams illustrates that the way hospitals manage patient flow can have an impact on patient health. For example, overcrowding can lead hospital managers to move patients who still need intensive care out of the ICU to free beds for even sicker patients. When patients are moved out of the ICU, they fail to receive the care they need, leading their conditions to deteriorate, and sometimes to a crash, at which point, a rapid response team takes over.

The main problem, however, isn’t lack of beds but rather how hospitals manage patient flow. For instance, many hospitals schedule all their surgeries during the beginning of the day and week; therefore, the ICU becomes overcrowded in the middle of the day and the middle of the week.

Pronovost worries that hospitals are using RRTs as a crutch. Instead, he says, hospitals need to better manage these conditions so as to prevent patients from worsening so that they don’t need to appeal to the use of rapid response teams, which, he says, only look good because patients are allowed to get so bad.

Source: RT Magazine online

You can read the original article in JAMA here (registration required)
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Some cancer screening tests have been so well proven to save lives, like the colonoscopy, that if you don't get one, you need more than your colon examined (to borrow from an old Cancer Society slogan about mammograms). But it's now clear that mammograms don't fit into guilt-trip status anymore. Using radiation to find lumps in the breast that are too small to feel with your hands has only a slight benefit.

Here are the numbers from the latest analysis in the New England Journal of Medicine. For every 2,500 women in the prime screening age group -- 50 to 69 -- you would need to give all 2,500 a mammogram at least every couple of years for ten years to save a single life. And in the process, 1,000 of the same women would turn up with a suspicious result, 500 of those would need a surgical biopsy, and five to fifteen of those would get cancers removed, and maybe entire breasts, that if left alone would never threaten the patient.

The medical journal analysis was written by Dartmouth medical school Dr. Gilbert Welch, who has long been a skeptic of the mammogram as a sacred cow of must-do medicine.

That means that the decision to have a screening mammogram is very much up to the individual. Some may want to take the risk of becoming an unnecessary patient to avoid the deadly but small risk of a preventable death from breast cancer. Others will prefer the option that seems to work better: Good vigilance and attention to small lumps, and then if a cancer develops, make sure you're in the hands of a multi-disciplinary team of cancer doctors who specialize in the latest treatments.

Here's an article by Gina Kolata about the latest study from Norway, in the New York Times.

And here's what the National Breast Cancer Coalition has to say about the myths and truths of breast cancer.

Time was when the Food and Drug Administration would give a new drug the go-ahead for marketing based on a handful of studies involving no more than a few thousand patients. Then millions of prescriptions would be written over the next few years, and the drug would finally have its real test of safety on the open market, with the American consumer as the guinea pig. If the drug flunked the real-world test, it would be taken off the market, with a flurry of product liability lawsuits and calls for regulatory reform. This script is familiar from fen-Phen to Vioxx.

Now with the FDA's decision to split the baby in half with the diabetes drug Avandia, many are saying a new and different era of prescription drug safety is upon us. Instead of the old Up-Or-Down, and sometimes later Out, the FDA is setting up what one drug industry commentator, Gooznews, calls Permission Slip Medicine.

To get a prescription filled for Avandia -- and presumably other controversial drugs down the road -- a patient will have to hand the pharmacist a signed slip of paper acknowledging that he or she has discussed the medication with the doctor and both have decided together that they really, really want to have this drug, despite the availability of other alternatives like Actos which doesn't seem to carry the risk of heart attack and stroke that Avandia apparently has.

I say "apparently has" for Avandia, because the drug agency says it's not really sure. Part of its decision to punt on Avandia, keeping it available but harder to get, included posting on the FDA website a series of memos from top level agency staffers showing how very sophisticated drug reviewers could read the same studies and come to opposite conclusions on safety and the need for more research. Click here to see the memos. Note the contrast between the memo by FDA firebrand David Graham, who wanted Avandia yanked completely from pharmacy shelves, as has happened in Europe, and more conciliatory memos by long-time agency officials like Robert Temple.

In the old days, the other option for an in-between drug like Avandia would have been to add a dire statement to the official product labeling about the newly discovered risk. This has already happened for Avandia. These warnings are often called black box warnings because they appear in bold face at the very beginning of the columns of dense prose of the official language published in the Physicians Desk Reference and various online sources.

But who reads the black box warnings? Certainly lawyers like me do, when a client comes calling with a serious injury or death and it turns out the drug culprit didn't have such a black box warning, or their doctor didn't mention it to them. But if my experience is any measure, many doctors pay little attention to the official label. That's part of the long-running scandal of prescription drug education in the United States, which is dominated by the legions of drug salespersons who regularly trundle their briefcases of free samples and glossy handouts down the back hallways of doctor offices.

The new FDA action is intended to force doctor and patient to sit down quietly together and make a reasoned decision about whether this drug is right for this patient, despite the bad stuff that has happened to other people. That may be a good thing.

Avandia is one of the growing class of drugs that once you're on it, you swallow the pill every day for the rest of your life. The goal for Avandia is to lower blood sugar in diabetics, and that can prevent other bad long-term issues like diabetic blindness (retinopathy) and kidney disease. So the good intent is there.

But with a safer alternative apparently out there, what's the point of loading extra risk onto the patient? That's a dialogue that the FDA has now shifted from its officials onto the desks of individual doctors.

A new book by a prostate cancer survivor and his physician casts yet more doubt on the necessity of surgery for most prostate cancer patients.

Invasion of the Prostate Snatchers, by Ralph H. Blum and Dr. Mark Scholz, an oncologist who has treated the disease exclusively since 1995, examines available prostate cancer treatments as well as the multibillion dollar prostate cancer industry. Blum, a cultural anthropologist and writer, has lived with prostate cancer for 20 years without radical treatment.

As many as 200,000 new cases of prostate cancer are diagnosed each year in the U.S., most of which are overtreated, the authors maintain. Most men, they say, would be better served having their cancer managed as a chronic condition, with “active surveillance” the most effective initial treatment in most cases.

The book notes that only 1 in 7 men with newly diagnosed prostate cancer are at risk for a serious form of the disease. According to Scholz, that means that most men diagnosed with prostate cancer would live just as long without surgery, and “don’t need to have their sexuality cut out.”

A recent study in the New England Journal of Medicine appears to support Scholz’s contention, suggesting that radical prostatectomy – still the most often recommended treatment – extended the lives of just one patient in 48.

Side effects of radical prostatectomy include incontinence, impotence and shrinking of the penis.

Source: The New York Times

You’ll find more information about the book here.

The Occupational Safety and Health Administration (OSHA), the main federal agency charged with the enforcement of workplace safety and health, is looking at limiting the number of hours medical residents can work to 80 hours a week.

The decision to consider such limits came after OSHA received a petition filed by Public Citizen; the Committee of Interns and Residents/SEIU Healthcare; the American Medical Student Association; Dr. Charles Czeisler, Baldino professor of sleep medicine and director of the division of sleep medicine at Harvard Medical School; Dr. Christopher Landrigan, assistant professor of pediatrics and medicine at Harvard Medical School; and Dr. Bertrand Bell, professor of medicine at Albert Einstein College of Medicine.

Petition signatories noted their concerns about medical residents working extremely long hours,” anc cited evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors, and motor vehicle accidents.

In agreeing to consider the petition, assistant secretary of Labor for Occupational Safety and Health David Michaels, who heads OSHA, noted that “the relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error. In its investigation of the root causes of the BP Texas City oil refinery explosion in 2005, in which 15 workers were killed and approximately 170 injured, the U.S. Chemical Safety Board identified worker fatigue and long work hours as a likely contributing factor to the explosion."

In addition to seeking a limit of 80 hours of work in each and every week for hospital residents, the petition also seeks:

A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;
At least one 24-hour period of time off work per week and one 48-hour period of time off work per month, for a total of five days off work per month, without averaging;
In-hospital on-call frequency no more than once every three nights, no averaging;
A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;
A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

Source: Occupational Health and Safety Magazine

You can view Dr. Michaels' full response to the petition here.

Also, here's one surgeon's entertaining take on the issue, in the Psychology Today blog. You can guess his point of view by his title: "Training surgeons not sissies."

Until now, it’s been easier to rate appliances and restaurants than surgeons in most parts of the country, but that should change now that surgeons who perform cardiac bypass surgery are being rated on objective quality measures in Consumer Reports magazine.

The consumer magazine recently published ratings of 221 surgical groups in 42 states online. The same ratings will be available in the October print issue. To date, only a few states, such as New York, compile data-based ratings of physicians.

The data Consumer Reports used to rate the physicians was collected the Society of Thoracic Surgeons, which includes more than 90% of cardiothoracic surgeons in the U.S. in its membership. Physician groups, not individual surgeons, were rated either above average, average or below average based on (a) complication and survival rates; (b) the surgical technique used; and (c) the type of medication(s) the patient was sent home with after surgery.

An article in the New England Journal of Medicine called the move to make this data public “a watershed event in health care accountability.”

The 221 groups rated in Consumer Report represent less than a quarter of physician groups that perform bypass surgery in the U.S., as only surgical groups that allowed their information to be published were rated. Of these, only five were rated below average, which is fortunate, because the gap in treatment between a below-average and an above-average surgical group can be extremely wide; for instance, at an above-average hospital, patients had a 92% chance of receiving the recommended medications when leaving the hospital; at one of the below-average hospitals, patients had only a 24% chance of getting the recommended drug.

For now, the information is available only to people who subscribe to Consumer Reports online and print subscribers. However, STS says it will make the ratings freely available on its web site in a few months.

Source: New York Times
Visit the web site of the Society of Thoracic Surgeons (STS) here.

A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers.

They were developed using Failure Mode and Effect Analysis (FMEA), a scientific methodology that identifies where problems occur in the use of pain medications and the underlying causes of those problems. The FMEA research identified 79 areas where problems occur in the use of opioidsand 290 potential causes of those failures.

Tools now available include clinical materials and risk assessments for physicians, safe-use guides for patients and general education for all groups. The organization also plans to develop additional tools based on the research.

Jeffrey Gudin, MD, a pain management and addition specialist at the Englewood Hospital and Medical Center in Englewood, N.J., says that healthcare professionals need to do a better job of assessing our patients' pain medication needs and of communicating the risks of the medications they prescribe.

"Through the resources of the C.A.R.E.S. Alliance, patients, caregivers and health professionals will have access to information, tools and resources to help them better understand these risks and better ensure that the medications are used properly by only those for whom they are prescribed," he says.

The alliance, which is sponsored by Covidien, the largest producer of prescription pain medications in the U.S., also will work to ensure that patients suffering from chronic pain have access to necessary medications.

Source: Medical News Today
You can obtain tools and other resources here.

Nurse anesthetists have been proven to deliver about as safe and high quality care as physician anesthesiologists, but there's still a key question every patient should ask before being put to sleep by a nurse anesthetist.

"Is there a doctor anesthesiologist nearby in case there's an emergency during my surgery?"

That's the question you need to get answered. In most hospitals and many free-standing surgery centers, the answer will be, "Of course, we wouldn't dream of putting patients to sleep without an anesthesiologist supervising the anesthetists." But in other facilities, particularly same-day surgery centers, the answer will be, "No, we don't think it's necessary."

And that "no" should give you pause.

Anesthesiologists have MD degrees and broad training in medicine. They also spend a lot more years learning anesthesia than nurses who come up through a "CRNA" program (Certified Registered Nurse Anesthetist). It costs about six times as much to train an anesthesiologist as an anesthetist, and the anesthesiologists are paid about double what nurse anesthetists get paid.

If something goes terribly wrong during surgery -- and luckily that's a rare event nowadays, thanks to improvements in anesthesia technology over the last thirty years -- I know who I want nearby. That's an anesthesiologist.

You can read more about this in a series of letters to the editor in the New York Times debating the merits of state governments passing laws that opt their state out of the Medicare requirement that surgery centers have an anesthesiologist supervisor.

I discuss anesthesia and other issues about safe surgery in my book, "The Life You Save."

Healthcare providers need to know more about the efficacy and potency of hydromorphone, a pain killer frequently used as a morphine substitute in post-operative patients, to avoid medication errors and adverse drug reactions (ADR), says an advisory from the Pennsylvania Patient Safety Authority (PPSA).

Researchers hired by PPSA reviewed 1,694 medication error and 937 adverse event reports involving hydromorphone from January 2008 to October 2009. They identified lack of knowledge about hydromorphone potency and the difference in potency between morphine and hydromorphone as the most significant factors causing serious medication errors, particularly when a patient is switched from morphine to hydromorphone.

Hydromorphone is administered in doses that range from 0.4 mg to 2 mg, whereas patients may receive as much as 7-10 mg of morphine. Incorrect dosing may occur when prescribing, dispensing or administering hydromorphone when a physician, pharmacist or nurse confuses hydromorphone and morphine. Other medical errors noted in the study were giving patients the wrong drug and not noting a documented allergy.

Some adverse drug reactions to hydromorphone also may be preventable. The study found that of the 447 reported ADRs involving central nervous system or respiratory effects, 292 (65%) were preventable, and, of these, 205 (70%) resulted from dosing errors.

To reduce the number of medical errors and ADRs involving hydromorphone, the study recommended implementing risk reduction strategies such as constraints and standardization, which focus on system improvement. It also recommended writing hydromorphone with the first five letters capitalized (i.e. HYDROmorphone) to further distinguish it from morphine.

Source: Pennsylvania Patient Safety Authority
You can view the report here.

A study published in the Journal of the American Medical Association concludes that low-dose corticosteroid medications administered orally – which result in significantly fewer adverse effects – are just as effective as high-dose intravenous steroid injections in treating patients with chronic obstructive pulmonary disorder (COPD).

Corticosteroids figure largely in the treatment of COPD, either on their own or in conjunction with bronchodilators. However, their optimal dose and route of administration are uncertain. Currently, there are two basic options for the administration of corticosteroids in hospitals: (1) to administer the drugs orally at a lower dose (i.e. 60 mg over 2 days); or (2) inject a higher dose (i.e. 600 mg over 2 days) intravenously.

Although the recommended treatment is to administer the lower dose orally, nearly all (92%) COPD patients receive the higher-dose intravenous injections, increasing their risk of having an adverse event.

The study was conducted at 414 US hospitals involving patients admitted with acute exacerbation of COPD in 2006 and 2007 to a non-intensive care setting and who received systemic corticosteroids during the first 2 hospital days.

Of 79,985 patients the study looked at, 73,765 were initially treated with intravenous steroids, whereas 6,220 received oral treatment. Of these, 1.4% of the intravenously treated and 1.0% of the orally treated patients died during hospitalization. In addition, the risk of treatment failure was lower among orally treated patients, as was the length of the patient’s hospital stay.

The study determined that lower, and therefore safer, doses are just as effective in treating COPD and also save about $500 per hospitalization. By this measure, U.S. hospitals could save a total of $250 million by treating COPD patients with orally taken low-dose corticosteroids.

Source: Patient Safety America Newsletter, August 2010. View it here.
You can view the study here.

A young health care journalist named William Heisel has put together a fascinating Google map of the United States highlighting case after case of state licensing boards going easy on doctors who abuse drugs, send fraudulent bills or engage in other misconduct. Check it out here.

For the latest news on Mr. Heisel's blog about dangerous doctors, see this story about a psychiatrist who has been welcomed to Maine by the licensing board there despite a checkered history including a fraud conviction, drug abuse, a competence inquiry, and some forgetfulness to mention much of this on his licensing application.

Piecing the story together about a doctor who has traveled from state to state, with multiple disciplinary actions, takes practically a Pulitzer Prize level journalistic inquiry.

Mr. Heisel rightly raises the question about why these publicly funded state licensing boards are so secretive and slow to divulge information even when they have taken concrete action. Among the boards he criticizes: Maryland, where the licensing board says only that the doctor once worked there. This is in keeping with the experience of malpractice lawyers like me who know that the Maryland Board of Medicine is slow to act and won't tell consumers much even when it has. (I discuss this in more depth in a chapter on "dangerous doctors" in my book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Whose interest are these medical boards serving?