May 15, 2013

Half of Hepatitis C Patients Risk Dire Illness Through Incomplete Testing

It has been about a year since the Centers for Disease Control and Prevention (CDC) recommended that all members of the baby boomer generation get tested for hepatitis C to determine, as we wrote, if they harbor the virus, or if they’ve already been compromised by its presence. The hep C virus can cause liver disease and cancer.

Some people do get tested, but the CDC reported last week that nearly half of Americans who test positive for hep C do not get the second test required to confirm or deny its presence.

As explained on MedPageToday.com, there’s an initial screening to detect hep C antibodies; if that result is positive (HCV), another test, HCV RNA, is necessary to determine if the infection itself is present. (The second test also tracks the quantity of hep C at any given time during the course of treatment.)

Without the second test, you can’t tell if the positive antibody test represents real evidence of infection, a false-positive or merely leftover antibodies from a cleared infection.

Hepatitis C is contagious. (See our blog about how a rogue hospital worker spread the infection across many states.) So it’s in the interest of the public as well as infected patients to be tested completely. Sometimes the virus can clear on its own, but in about 8 in 10 cases, treatment is required to protect against life-threatening illness.

The CDC studied two major cities (San Francisco and New York) and six states over a seven-year period. It found that nearly half of newly reported HCV patients had gotten only the first test, for antibodies to the virus. The results of this survey combined with previous research suggests to the CDC that about 3 million Americans have HCV and that as many as 3 in 4 don't know it.

One caveat: The CDC report included only positive results, so it's unclear how many people who were antibody-positive turned out to be RNA-negative.

If you’re aware that you’re infected, according to CDC Director Tom Frieden, who spoke to a media gathering, you and your care providers can monitor your liver's condition and decide when or if to seek treatment. You can begin to make lifestyle changes, such as avoiding alcohol and some medications that can compromise liver function. And you can get vaccinated against hepatitis B.

Treatment for hep C is evolving: As noted on MedPage Today, the FDA has approved two drugs that markedly improved clearance rates when added to previous treatments (including interferon, an immune-booster that’s difficult to tolerate and accompanied by significant risk). And several other so-called “direct-acting agents” are being developed and are expected to enter the treatment scene soon. Many of these potential treatments needn’t be combined with interferon.

Most people with HCV have not been tested, and the CDC’s investigations confirm the wisdom of it, especially for baby boomers. Nearly 7 in 10 people who tested positive on both tests were born from 1945 to 1965. Slightly more than 7 in 10 people who died from the infection were born during that period.

As Frieden said, baby boomers “may not remember everything that happened in the '60s and '70s, but their liver does.”

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April 23, 2013

Lack of Authority, Resources Invites Contamination at Compounding Pharmacies

"Houston (and anywhere else there’s a compounding pharmacy) we have a problem." So says FDA Commissioner Dr. Margaret Hamburg, who wrote a blog on FDA Voice expressing concern about the lack of regulatory authority over the facilities that make customized, prescription medicines like the contaminated steroids that killed 53 and sickened 733 people last year. (See our blog post, “Drugs ‘Compounded’ by Pharmacies: A Disaster Waiting to Happen.”)

Despite resistance by compounding pharmacies, according to AboutLawsuits.com, state and federal agencies have been investigating them, and not liking what they see. Such pharmacies are supposed to fill a specific need: making customized drugs to order for local patients when the meds are not available commercially or in the right delivery system. But some, apparently, operate more like, as AboutLawsuits puts it, “stealth drug manufacturers, selling products nationwide in large amounts without any federal oversight.”

The New England Compounding Center (NECC), the outfit that allegedly caused the outbreak last autumn of fungal meningitis, shipped some 17,000 vials of injectable steroids across the country, and even employed sales representatives to promote it. If that’s not Big Pharma behavior, what is?

It’s cold comfort that NECC is facing criminal charges, lawsuits and bankruptcy—what’s needed, says Hamburg, is a bigger hammer of authority.

As reported by Reuters, Hamburg testified before Congress in November that the law was insufficient to enable the FDA to aggressively enforce rules and punish violators, noting that compounding pharmacies mostly are regulated by the states. Republican lawmakers countered that that the agency has authority but fails to use it properly.

Now, it seems, patient safety is the political football in a game between a divided Congress and the FDA. Last week, as reported by ABC News, House Democrats issued a report showing that most states are lax in their oversight of compounding pharmacies, and congressional investigators say state pharmacy boards lack the information and expertise to oversee them.

Of 49 states in the report, only Missouri and Mississippi provided the exact number of compounding pharmacies in their state. They were the only two that require permits or licenses for pharmacies that perform compounding. No state reported having tracked pharmacies that sell compounded drugs across state lines or in large quantities.

Many states, ABC reported, don’t keep inspection records of compounding pharmacies, and 22 don’t keep histories of problems like contamination, cleanliness and drug potency. For some states, record-keeping amounts to a combination of inspection reports, complaints and "staff recollections."

The average pharmacy board has five inspectors to visit all the pharmacies in the state. Only 19 states train inspectors to recognize problems with sterile compounding.

The next day, Republicans issued a report charging that the FDA’s sloth was the problem, not its authority. According to the Associated Press, the GOP said the agency should have closed NECC years earlier, and has always had the authority to do so. And lawmakers on both sides of the aisle called the FDA on carpet for its lack of aggressive action on compounding pharmacies generally.

In her blog, Hamburg said that the FDA has inspected 31 compounding pharmacies considered high risk and found objectionable conditions at 30 of them. Specifically, the FDA was investigating how well the facilities maintained sterile conditions and minimized the risk of contamination. You can read a summary of these inspections here.

In some cases, the feds had to get court warrants because the pharmacies delayed and resisted inspection, and U.S. marshals had to accompany the inspectors. Can you imagine a meat-processing plant engaging in such an act of defiance? An exotic flower importer turning away customs inspectors charged with keeping pests out of the country? And these people claim to be providing products people trust with their lives?

No wonder Hamburg seeks authority and resources for the FDA to police compounding pharmacies nationwide before there are violations, before someone else gets hurt or killed because the people who made their medicine took less care with hygiene than they would changing the fry oil at McDonald’s.

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March 16, 2013

Rabies from Infected Kidney Kills Transplant Recipient

The story begins in 2011, when a young Florida man died of brain inflammation from an unknown cause, and organs from his body were transplanted into four recipients. Fifteen months later, a Maryland man died of rabies, and now it turns out to have come from the transplanted kidney he got from the Florida donor. The question now is, could anything have been done to prevent this tragic outcome?

The Centers for Disease Control and Prevention just confirmed the link after DNA testing matched the disease in the two victims. The recipient received his transplant at Walter Reed National Medical Center in Bethesda, Maryland and just died at the Veterans Hospital in Washington, DC.

Organ donation officials stress that rabies is extremely rare -- you can count the number of human deaths in the United States each year on one hand. The other problem is that there is no simple test that can be done quickly enough to get an answer while the organ being transplanted is still viable.

But why would anyone take organs from a donor who died of a mysterious brain infection like encephalitis, as this donor did?

Even that question has no easy answers.

A takeout by Betsy McKay in the Wall Street Journal reports that symptoms of encephalitis can be hard to distinguish from other causes. This is according to Dr. Michael Green, chair of the disease transmission advisory committee for the United Network for Organ Sharing. Dr. Green, a professor of pediatrics and surgery at the University of Pittsburgh School of Medicine, told Ms. McKay:

"If you knew someone had encephalitis, the recommendation would be to be extremely cautious before using any organs. The problem is identifying everyone who has encephalitis."

The Journal report said that seven disease transmissions are reported for every 5,000 donations, and death is very rare.

The other three recipients of organs from the infected donor are being treated and are reportedly doing okay.

UNOS is urging closer scrutiny of potential organ donors for encephalitis, which it says has been underecognized in donors but is highly transmissible.

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March 15, 2013

Antibiotic Zithromax Can Kill by Messing with Heart Rhythm

This week the FDA renewed a warning it had first sounded last year about the antibiotic azithromycin. But it wasn’t just a reminder that the drug, whose brand name is Zithromax, or Zmax, carries risks—this was a graver assessment that azithromycin can cause the heart’s electrical rhythms to change which, for some people, can be fatal.

As widely noted in the media, including the New York Times, the initial warning came on the heels of research published in the New England Journal of Medicine (NEJM) last spring. Since then, warning labels have been included on the drug’s packaging, and the FDA has been reviewing the study.

The data showed a modest increase in the likelihood of death in people with a five-day course of azithromycin compared with patients treated with other antibiotics including amoxicillin (Amoxil) and ciprofloxacin (Cipro, Proquin).

As The Times notes, azithromycin was believed to be safer than a couple of other related antibiotics, erythromycin (Erythromycin) and clarithromycin (Biaxin), which also can raise the risk of death. But it has leapfrogged those drugs in concern over heart problems. The new, more serious FDA warning says patients at risk of the heart arrhythmia include the elderly and those with a history of heart problems, low blood levels of potassium or magnesium, slow heart rates and anyone taking medication that slows the heart rate.

People typically are prescribed azithromycin for bacterial infections such as bronchitis and pneumonia, sore throats and earaches. Commonly called “Z-Pak,” it’s taken for five days, which most people find preferable to many other antibiotics that must be taken for twice as long.

If you are taking azithromycin or if your doctor prescribes it, ask about the cardiac risks of the drug. Ask if any other drugs you take slow your heart rate. Ask if another antibiotic in the same class, such as fluoroquinolones (levofloxacin, moxifloxacin, norfloxacin) can be substituted for azithromycin. Like all drugs, they, too have potential risks and side effects, but do not present the cardiac risks of azithromycin.

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March 13, 2013

Officials Warn About Deadly Drug-Resistant Bacteria

Hospitals are hotbeds for infections because that’s where sick people go. And because those people are already weak, they’re more vulnerable to opportunistic organisms that proliferate in that environment. As we have reported, awareness is increasing of how hospital infections spread and how to minimize that traffic, even if the cause-effect-response process is difficult to track.

Control of hospital-acquired infection, according to the Centers for Disease Control and Prevention (CDC) just got a whole lot harder.

As widely reported last week, including in the New York Times, the CDC said there was a small window of opportunity to stop the spread of a virulent hospital bacteria.

The bacteria resist a class of antibiotics called carbapenems, a group of drugs usually given as a last resort. Carbapenem-resistant Enterobacteriaceae (CRE) are so lethal that the death rate of people who have contracted an infection is 1 out of 2. Dr. Thomas R. Frieden, director of the CDC (an organization not given to alarmism), called the bugs “nightmare bacteria” because they could pass their drug resistance on to other bacteria.

Most people who fall victim to CRE already are sick with problems requiring complicated treatment and long stays in hospitals, nursing homes or long-term care facilities. So far, the infections seem to be limited to these facilities, but without a worthy antibiotic opponent, they could spread to the community at large.

The findings of the CDC report are a call to action, the agency says, “for the entire health-care community to work urgently … to protect patients. During just the first half of 2012, almost 200 hospitals and long-term acute care facilities treated at least one patient infected with these bacteria.”

A blog on the CDC site written by Dr. Arjun Srinivasan of the agency’s Division of Healthcare Quality Promotion noted that:


  • In the first half of 2012, about 4 in 100 short-stay hospital visits in the U.S. involved at least one patient with a serious CRE infection; about 18 in 100 visits in long-term acute care hospitals had one. Nearly 200 facilities were involved.

  • One type of CRE has been reported in medical facilities in 42 states.

  • The most common type of CRE increased sevenfold in the last 10 years.


Srinivasan warned “New drugs won’t be here for many years, so we must do everything we can to preserve current antibiotics for as long as possible. “

He’s optimistic, saying that the CDC has mapped out specific guidelines that can halt CRE infections before they become widespread. He said that some medical facilities already have reduced or stopped CRE rates by following the guidelines.

What’s required to halt the invaders, according to The Times, is “the usual call for ruthless scrubbing of all surfaces and relentless hand-washing,” isolating infected patients and assigning dedicated-care teams and equipment to them. To see the complete guidelines, link here.

If you or a loved one is a hospital patient, you must be aware of the risk of infection. Make sure the caregivers remove catheters and intravenous lines as soon as possible—they’re a direct path for bacteria. Make sure doctors are prescribing antibiotics only when they are truly needed—unnecessary use of these drugs simply makes bacteria more resistant to them, and harder to eradicate next time. Also, wash your hands before touching the patient, and make sure every caregiver does too.

To learn more about hospital-acquired infections in general, see our backgrounder.

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February 6, 2013

Some Hospitals Reuse Insulin Injector Pens

You might remember a blog we wrote last year about safe injection practices, and how hepatitis, HIV and infections can be spread when hygiene is not a priority.

Nothing is stupider than reusing invasive medical equipment, but a couple of hospitals in New York don’t seem to have a very high safe-injection IQ. As reported on AboutLawsuits.com last month, Buffalo Veterans Administration Center and Olean General Hospital have both been found to have reused insulin pens on different patients.

Such devices are designed to be reusable, but only for the same patient, and only when the needles are changed after each injection. Although the hospitals used new needles for each patient, blood can still back up into the pen, which makes them safe only for one user. But the New York hospitals apparently allowed multiple patients to use a single pen. All of them are now at risk of hepatitis C and HIV.

Olean General warned 1,915 patients that they might have been exposed between November 2009 and Jan. 16, 2013, and Buffalo Veterans warned more than 700 patients who might have been exposed between October 2010 and November 2012. So far, there are no reports of disease transmission caused by the improper use of the insulin pens, but the incubation period for HIV can be two years. Hepatitis C can incubate for six months.

If you or a loved one received an insulin pen injection at either of these facilities, contact them immediately to receive free blood tests. In addition, Olean has a call center for anyone with questions—(888) 980-1220.

For everyone else, the lesson is always to watch the preparation of an injection. If you don’t see how the medication was prepared, whether it involves a pen, syringe or IV tube, ask the doctor, nurse or other health-care aide who is giving it to you if the both the dispenser and the needle are fresh. If you have any question that they aren’t, decline the medication until you are allowed to see its preparation.

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January 31, 2013

Required: A Flu Shot for Every Hospital Worker

If the staff of any particular work site should be required to get a flu shot, it’s the people working in a hospital. Guarding against the flu in the hospital isn’t just a matter of personal protection; it’s a matter of patient protection and safety.

So why do so many doctors, nurses, technicians, service workers and clerks go unvaccinated?

It’s a question Dr. Bob Wachter addresses on his blog, Wachter’s World. He’s professor and associate chairman of the department of medicine at the University of California, San Francisco, and a renowned hospitalist. That medical specialty is dedicated to the delivery of comprehensive medical care to hospitalized patients.

Wachter believes getting a flu shot shouldn’t be optional for hospital workers. Hospital patients are more vulnerable to infection because they’re already sick, because many are older (which is an added risk factor) and because they’re at higher risk for contracting other infections, so they need to be protected from the introduction of any additional microbes.

As Wachter writes, “[I]nfluenza can be an unpleasant inconvenience for a healthy person, but, for older and immunosuppressed patients, it can be a killer. … While one would hope that the professionalism of clinicians would drive them to vaccinate on behalf of their patients’ welfare (and most do – CDC data shows that about two-thirds of hospital workers get the vaccine), it’s not enough.

“Sorry folks, but this one should not be a choice. It should be a mandate.”

At his hospital, clinicians who refuse the vaccine must wear masks during the flu season. More than 9 in 10 people there are vaccinated, and as a result, he reports, there have been no recent cases of clinician-to-patient (or vice versa) transmission, unlike in the days before the vaccine (or mask) was required.

Wachter refers to a Centers of Disease Control and Prevention (CDC) survey from 2011 that found that more than 400 U.S. hospitals (about 1 in 10) now require flu vaccine for employees; 29 of them fire unvaccinated employees.

The Joint Commission, an independent, nonprofit organization that accredits and certifies health-care organizations, now requires accredited hospitals to have a program for promoting staff vaccinations.

Still, Wachter says, some health-care personnel object to the vaccines because they are worried about side effects (which are rare) or about how well they work (this year’s vaccine is 62 percent protective). These objections are surprisingly strong among a population of people who should know better. A recent article refutes them in the Journal of the American Medical Association.

But some people object to being forced to get the shot purely as a breach of their rights. “One nurse in Indiana who was fired for refusing the vaccine,” Wachter reports, “spoke of ‘the injustice of being forced to put something in my body.’”

OK, then don’t be a health-care worker. It’s that simple. Your rights shouldn’t override those of patients who are in no position to protect themselves from you.

As Wachter says, “The average hospitalized patient … will see up to 50 different healthcare workers each day. Any one of them with the flu can put their patients at risk, and not all of them will have full-blown symptoms to warn them to stay away. Patients giving their trust to healthcare professionals have a right to know that we have done everything within reason not to compromise their health further.”

For Wachter, it’s not just a single practice for patient safety; it’s a matter of changing a paternalistic culture. “[L]et’s require flu shots, not just to prevent flu but also to begin to shift our culture to one in which we actually require people to do things when they are the unambiguously right things to do.”

It’s a little late—although not too late—to improve the odds for this season that hospital workers won’t give you the flu along with your treatment. You should advocate for vaccination.

Ask your caretakers if they’ve been vaccinated, and if not, request that they wear masks when treating you. Ask the hospital’s patient advocate what is the facility’s flu vaccination policy. Make sure that person knows of your concern. And let your health insurer know if unvaccinated staffers are treating you or your loved ones.

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December 30, 2012

Boy’s Death from Sepsis Spurs Guidelines to Prevent Malpractice in Treatment

Earlier in 2012, we wrote about the sad, unnecessary death of Rory Staunton, a 12-year-old New Yorker who died of septic shock because he was misdiagnosed with a stomach bug. A good thing has come of that tragic event.

As the New York Times reported, New York will be the first state to require hospitals to look aggressively for sepsis, a life-threatening bacterial infection of the bloodstream or body tissues, in order to initiate treatment sooner. (See our backgrounder on sepsis and malpractice.)

The regulations currently being drafted demand that hospitals also must publicly report the results of their efforts to control and treat sepsis.New York’s action, which the governor hopes to implement in 2013, reflects the interest of a national panel that recommended the adoption of similar standards on a federal level.

Sepsis is a leading cause of death in hospitals. Dr. Mitchell M. Levy, author of a forthcoming paper on sepsis treatment, told The Times that sepsis is “the most common killer in intensive care units. It kills more people than breast cancer, lung cancer and stroke combined.”

Recent efforts by the Surviving Sepsis Campaign, a global community of medical professionals, have established guidelines on identifying and treating sepsis, and mortality rates have declined by 40 percent as a result. But because the early signs of sepsis—high pulse rate, fever—are similar to those of many other illnesses, it’s difficult to diagnose it conclusively in its early stage.

But the key is to catch it early, when it can be treated effectively with antibiotics and fluids. The problem is that many hospitals don’t follow the guidelines. One sepsis research program involves some 300 hospitals, but the global consortium would like to have 10,000 participants.

As The Times reports, in April 2012, Staunton died of severe septic shock after he became infected, apparently through a cut. He was treated in the emergency room of NYU Langone Medical Center, where the severity of his illness was not recognized as soon as it should have been, nor were the indications communicated effectively when they were known. Staunton was sent home with a diagnosis of stomach pain. When his laboratory results came back after he checked out, showing cause for alarm, his parents were not contacted. The publicity following his death prompted the medical community to pay attention.

New York’s health commissioner, Dr. Nirav R. Shah, convened a symposium on sepsis that included presentations from Staunton’s parents. Shah said the new regulations requiring hospitals to use best practices in identifying and treating sepsis were actions taken “in honor of Rory Staunton.”

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October 9, 2012

Updates on the Mounting Toll from Contaminated Drugs "Compounded" by Mass. Pharmacy

The death and disability toll from the contaminated spinal pain relief drugs "compounded" by a New England pharmacy continues to mount. Patients have come down with serious infections in Maryland, Virginia and eight other states, according to the Centers for Disease Control. Check this CDC web page for updates and good advice on what patients should do if they feel any unusual symptoms after a spinal injection.

Patients who are looking into possible legal action against the pharmacy should make sure that the clinic where they got the injection keeps all records of who sold drugs to the clinic.

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October 5, 2012

Drugs "Compounded" by Pharmacies: A Contamination Disaster Waiting to Happen

The ongoing outbreak of spinal infections -- with so far five patients dead and 30 with serious meningitis infections in six states, including Maryland and Virginia -- shows the antiquated regulatory system for drugs that are compounded by a pharmacy.

All the injected steroid drugs that have sickened and killed patients came from a pharmacy in Massachusetts that was "compounding" the drugs: in other words, mixing different drugs together and essentially manufacturing a new drug. The drugs were contaminated with a common fungus known as aspergillus. When injected into patients' spines for chronic pain, the patients got a fungal infection of the meninges, the lining of the spinal cord and brain.

The Food and Drug Administration closely regulates the manufacture of drugs by regular manufacturers. But the pharmacies that essentially manufacture drugs are in a regulatory shadowland. They are allowed to engage in the ancient art of "compounding" on the theory that they are making customized products for individual patients. But some have enough volume, like the pharmacy in Massachusetts that sold its contaminated injection drug across the entire eastern U.S., that they really should be treated as any other manufacturer.

The New York Times has a good story explaining this regulatory gap that endangers patients who unknowingly receive these compounded drugs.

The gatekeepers are the pain management doctors and pain clinics that order these drugs. I have spoken with pain management specialists who tell me they would never dream of buying drugs from any except an established manufacturer. But big clinics and hospitals can sometimes save money by buying from the compounding pharmacies. And patients never know what they're getting.

It's a scary proposition that needs new oversight from drug safety agencies. In the meantime, if you're a chronic pain patient who gets these injections, ask your doctor what source he is using.

Check our website for an article on other ways that patients can get infections in hospitals and clinics, which has links to prevention techniques.

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September 16, 2012

We Don't Know Enough About Antibiotic Use in Animals

The use—and overuse—of antibiotics is a hot topic in health care, largely because of the ability of bad bugs to mutate and develop resistance to treatment. Our most recent discussion of the problem concerned the diminishing number of drugs to treat gonorrhea.

As much as antibiotics are prescribed and abused for human use, according to a recent story in the New York Times, 80 percent of the antibiotics sold in the U.S. are administered to livestock—chicken, pigs, cows and other animals that people eat. But, remarkably, producers of meat and poultry are not required to report how they use the drugs. They’re not required to specify the drugs they use, what animals get them and in what quantities.

“This dearth of information,” says The Times, “makes it difficult to document the precise relationship between routine antibiotic use in animals and antibiotic-resistant infections in people, scientists say.”

So despite situations like the one earlier this year, when a salmonella strain resistant to many antibiotics multiplied tenfold on chicken breasts—the most commonly eaten flesh on U.S. dinner plates—scientists remained puzzled by a paucity of data they could use to decipher the bug.

That’s a challenge not only to resolve a potential health issue, but it deprives scientists of hard data supporting the notion that the routine use of antibiotics in livestock is a major player in antibiotic resistance.

“It’s like facing off against a major public health crisis with one hand tied behind our backs,” Keeve Nachman, an environmental health scientist at the Johns Hopkins Center for a Livable Future, told The Times.

For people, antibiotics are the front line against bacterial infection. For animals, they encourage growth and, therefore, profit for the interests that sell them as food.

The FDA has attempted to regulate the use of antibiotics in animals sold for food. Most recently, it restricted the use of cephalosporins in animals, which we noted earlier this year. This class of antibiotics is the most common treatment for pneumonia, strep throat and urinary infections in people.

Consumer health advocates decry the FDA’s reluctance to use its authority more aggressively against overuse and abuse of antibiotics. Even as early as 1977, according to The Times, the agency announced that it would begin banning some agricultural uses of antibiotics. But Congress caved to the commercial agricultural interests and passed resolutions against prohibition. The FDA retreated.

John Glisson, director of research programs at the U.S. Poultry and Egg Association, an industry group, told The Times that poultry feed mills “keep detailed records of antibiotic usage in the feed they manufacture [and that the FDA] has the authority to inspect and audit these records.” He said the agency has open access to these records.

Regulators say it’s not that easy. They might have authority to review food manufacturer records, but they may not publish the data.

In July, The Times reports, the National Pork Producers Council said that its members should not be required to report on antibiotics because it would add complexity.

Well, yeah. Science, medicine, the maintenance of health are complicated. That’s not a reason to decline to practice them.

The data collection so critical to scientific scrutiny is doable for human use thanks to the infrastructure of the U.S. health-care system. But, as The Times notes, “there is no equivalent for animals, making it harder to track use on farms and ranches,” according to William Flynn, deputy director for science policy at the FDA Center for Veterinary Medicine.

Some data are regularly released — a measure of antibiotic-resistant bacteria carried by meat and poultry. But the samples are so small that scientists don’t find them compelling evidence.

For example, the chicken breasts that bore a shocking increase in salmonella resistant to at least five classes of antibiotics? Only 171 breasts composed the sample—a tiny fraction of the 8 billion-plus birds raised and sold as food every year in the U.S.

The FDA is trying to curb the practice of many drugs sold over the counter through feed suppliers. The agency has proposed eliminating the use of some antibiotics to stimulate growth in animals, and requiring a prescription before meat and poultry producers could give certain antibiotics to their animals.

But regulatory responsibility is too uncoordinated, some observers say, to effect any significant change. The FDA regulates drugs, but the Department of Agriculture is responsible for livestock. And the Centers for Disease Control and Prevention (CDC) also weighs in.

“There’s nobody in charge,” Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida, told The Times. “And when no one’s in charge, it doesn’t get done.”

Flynn, from the FDA, told The Times his agency was moving as fast as it could to make sure antibiotics are used judiciously in farm animals.

We’re not convinced.

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September 2, 2012

Maryland Medical Staffing Agency Placed Rogue Tech into Hospitals Where He Infected Patients with Hepatitis

A Maryland-based medical staffing agency is at the center of allegations that it placed a rogue radiological technician into a number of hospitals in Maryland and other states. The technician is believed to have infected dozens of people with hepatitis C.

Maxim Staffing Solutions, a national firm with headquarters in Columbia, Maryland, placed technician David Kwiatkowski into three Baltimore hospitals: Baltimore Veterans Affairs Medical Center, Johns Hopkins Hospital and Maryland General Hospital, and also at Southern Maryland Hospital in Clinton, between 2008 and 2010.

Kwiatkowski was arrested in late July in New Hampshire after he was caught in a hospital stealing narcotic drugs that were intended for patients. He now faces federal charges.

The four Maryland hospitals are sending notices to several hundred patients to get testing for hepatitis C, a viral infection of the liver that, in bad cases, can lead to liver destruction and need for transplant.

Whether Maxim had reason to suspect the technician's danger to patients has yet to be determined. Lawsuits are likely against Maxim and another staffing agency that sent him to hospitals in as many as seven states in the last few years.

It's also unclear whether any of the Maryland hospitals had an inkling of problems with the technician. But at least two other hospitals, the prestigious UPMC Hospital in Pittsburgh and the Arizona Heart Hospital in Phoenix, fired Kwiatkowski after finding him with narcotic drugs.

A couple of months ago, we wrote about the sloppy, widespread clinical practices that put patients at risk of contracting hepatitis C, but this case, it appears, goes well beyond carelessness.

Maxim Staffing is alleged to have sent Kwiatkowski to UPMC in the spring of 2008. There, he was observed by another employee placing a syringe containing fentanyl, a Schedule II narcotic, in his pants. He replaced the missing syringe with another containing another liquid. Management confronted him, found three empty syringes with fentanyl labels on his person and an empty morphine syringe in his locker. His urine tested positive for fentanyl and opiates.

He was fired.

But UPMC did not report the theft, use or diversion of its controlled substances to any government agency or law enforcement authority. The technician was free to practice his alleged crimes elsewhere, and Maxim placed him in a matter of weeks into the first of four Maryland hospitals where he worked.

By the time he tested positive for hepatitis C in June 2010, dozens of patients who had undergone cardiac catheterizations at the hospitals that had employed him had been exposed to a common strain of hepatitis C. Most of them have learned only in recent months of their diagnosis. Based on this information, thousands of cardiac catheterization patients at hospitals where he worked are being tested for hepatitis C.

As noted in our backgrounder, hepatitis C can cause liver failure. The blood thins, and patients bleed easily. In the worst cases, called fulminant hepatic failure, the brain swells and the patient goes into a coma. About half of these patients die without an emergency liver transplant.

In July, a warrant was issued in New Hampshire for the technician’s arrest for acquiring a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge, and for tampering with a consumer product with reckless disregard for the risk he posed to others of death or bodily injury, and for the serious bodily injury that has befallen others.

It’s shocking enough that a drug addict in a position to contaminate hospital equipment with a deadly virus not only would be hired and rehired and rehired without regard for his illness or the harm he created for others. But that the hospital and the staffing agencies that knew about the risk failed to report his crimes is unconscionable.

The tech was placed by Maxim into the four Maryland hospitals AFTER his firing from the Pittsburgh hospital. What excuse does Maxim have for failing to find out what had happened in Pittsburgh and for enabling his further crimes? We will find out in the coming lawsuits.

We do know this much. As a result of this infected technician being given access to patients in seven states across the country, dozens of people face a dire infection, and countless others are left to wonder if and when it will strike. With a hep C diagnosis comes significant costs for treatment and care, the possible loss of livelihood and maybe even life itself. And none of it had to happen.

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August 23, 2012

Gonorrhea Resistance to Antibiotics Could Become a Public Health Crisis

Until last week, you didn’t hear much anymore about gonorrhea, a sexually transmitted infection formerly known as a “venereal disease.” It’s back in the limelight because the news is all bad. The Centers for Disease Control and Prevention says that gonorrhea is getting dangerously close to being untreatable.

The problem, as outlined by NPR, is that antibiotic options to treat gonorrhea are becoming increasingly limited. Basically, there’s only one antibiotic that can still eradicate the infection.

We’ve written before about the health threats of antibiotic resistance.

About 700,000 Americans get gonorrhea every year. If it’s left untreated, the infection can cause infertility and life-threatening ectopic pregnancies.

"Gonorrhea used to be susceptible to penicillin, ampicillin, tetracycline and doxycycline — very commonly used drugs," Jonathan Zenilman, who studies infectious diseases at Johns Hopkins, told NPR. But one by one, each of those antibiotics — and almost every new one developed since —stopped working. One reason is that the bacterium that causes gonorrhea can mutate quickly to defend itself, Zenilman said.

Another reason these drugs don’t work anymore is that they’re overprescribed and overused. That enables the bugs to “learn” how to survive against them; that is, they mutate until they become resistant. When antibiotics intended to treat gonorrhea also are used to treat urinary tract, upper respiratory and other kinds of infections, the germs are just given that much more opportunity to develop resistance. Also, when patients fail to take the full course of an antibiotic—that is, they stop taking the drug when their symptoms improve even though they’re supposed to take every pill in the prescription—bacterial resistance improves.

Doctors recently had only two antibiotics that still worked well against gonorrhea — cefixime and ceftriaxone. But last week, the CDC announced that in the U.S., gonorrhea had started to become resistant to cefixime.

"We're basically down to one drug … as the most effective treatment for gonorrhea," one federal official said.

Even worse, cefixime and ceftriaxone are in the same class of antibiotics. So it's only a matter of time before ceftriaxone loses its punch, too. "The big worry is that we potentially could have untreatable gonorrhea in the United States," the official said. It has happened in other countries.

The CDC said doctors should stop using cefixime immediately, and has issued new guidelines for treating gonorrhea.

They know it won’t be easy: Ceftriaxone is an injection, not a pill. And it should be given along with at least one other antibiotic.

Even so, “it's only a matter of time based on the history of this organism until resistance does develop," the CDC official said.

In a follow-up story, NPR discussed the scope of the antibiotic-resistance problem with Dr. Arjun Srinivasan, an epidemiologist with the CDC. He made clear that the responsibility to stop overusing these drugs lies with both patients and doctors.

“As patients,” he said, “we need to be informed consumers. We should never demand antibiotics when our doctors don't think we need them. And as medical providers, we need to consider very carefully when we are writing a prescription for an antibiotic. We need to make sure that the patient actually needs the antibiotic.

“And if they do, we need to make sure that we're up on the latest information so we're giving exactly the right drug for exactly the right dose for exactly the right time.”

Srinivasan reviewed the need for hospitals and medical staff to practice infection control.

One of the major concerns with antibiotic resistance is the drugs’ use for livestock, which we discussed earlier this year, and how it promotes resistance via the food chain. Srinivasan, as a federal official, danced around that one, and someone called him on it in the story’s website comments:

“Dr. Srinivasin conveniently dodged the question about antibiotics in food animals given as growth promoters. It's unfortunate he did so; I assume he's not up on the issue. It's huge, probably more important than medical use.”

The development of new drugs is troubled, too, because—surprise!—the profit motive isn’t there. As Srinivasin said, “It's not simple to develop new antibiotics. Another thing that you hear from drug companies is, of course, that these are drugs for which there is not a substantial profit margin. And as drug companies, they have shareholders to whom they are responsible and they have a duty to try and develop drugs that are going to make money for their shareholders.”

He suggests that this problem can be addressed through collaboration between government and Big Pharma.

Good luck with that.

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July 19, 2012

Fear-Mongering Rears Its Head in Hotel Room Germ Study

When the media glommed onto a news release issued by the American Society for Microbiology last month, America responded with a collective “ewwww.”

The study tallied the location and number of germs in the average hotel room. Researchers from the University of Houston concluded that the items most heavily contaminated with bacteria were television remotes, and that bacteria were transmitted from room to room aboard housekeeping equipment.

The point of this effort was to improve general hotel hygiene by standardizing cleaning procedures industry-wide.

According to the news release, “The study was designed as the first step in applying the Hazard Analysis and Critical Control Points (HACCP) system to hotel room cleanliness. Originally developed by the National Aeronautics and Space Administration, HACCP is a systematic preventive approach that identifies potential physical, chemical and biological hazards and designs measurements to reduce these risks to safe levels.”

Wow. That’s lofty.

As might be expected, toilets and bathroom sinks were pretty germy, but researchers also found high levels of bacterial contamination on the TV remote and the bedside lamp switch. Some of highest levels of contamination were found on items in the housekeepers' carts, including sponges and mops, which offer handy transportation for bacteria. Surfaces with the lowest contamination included the headboard, curtain rods and the bathroom door handle.

Holy hotel, Batman, what’s a traveler to do?

Fuggedaboudit, suggested Andrew Bender, writing on Forbes.com. “The viral spread over the last few days of a study on bacteria in hotel rooms has left me a little queasy. Not from the germs, but from the hype.

“…Try examining the story under the microscope.”

Despite such search engine-grabbing headlines as “Hotel rooms often contaminated with fecal matter,” Bender claimed, there’s no story here. That’s because of the more than 4.8 million hotel rooms in the United States, the researchers examined exactly … 9. Three rooms in one hotel in each of Texas, Indiana and South Carolina.

“That’s 0.000187 percent of the hotel rooms in America,” Bender reported, “and results varied from room to room. It would be comparable to saying that the combined citizenry of Chicago, Dallas and San Jose (about 4.84 million) was all, say, fans of the Kardashians, based on asking three people living on one block in each city.”

Not quite, but his point is well taken. Hotel rooms actually might be little germ factories with the potential to make you sick. But we can’t tell from this study. (The researchers, by the way, did acknowledge the limited nature of their work.)

“I’m all for hygiene,” said Bender, “but I think the fear-mongering based on such a self-admittedly inconclusive study was kind of inexcusable.”

One study with a sample so small you can barely see it with the naked eye does not a scientific conclusion draw.

Still. A lot of people have trafficked through your hotel room, and who knows how many of them are sneezing into their hands, then clicking the remote to watch “Keeping Up with the Kardashians”? It couldn’t hurt to take a packet of sanitary wipes on your next trip…

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July 15, 2012

"Lessons Learned in Blood:" Capt. Sullenberger on Preventing Medical Malpractice

Readers should check out a powerful NYT column by Maureen Dowd on the unnecessary death of a 12-year-old boy from an undiagnosed but easily treatable strep infection.

Rory Staunton's hero was Captain Sully Sullenberger, who safely landed the airliner in the Hudson. As Sullenberger told Ms. Dowd:

“If something good comes from Rory’s death, it will be that we realize we have a broken system. Patient care is so fragmented. For the most part, medical professionals aren’t taught these human skills that some deride as ‘soft skills.’ So there’s insufficient sharing of information and ineffective communication.

“Some in the medical field look upon these deaths as an unavoidable consequence of giving care. But they’re inexcusable and unthinkable.”

Our firm represented a family in a similar case a few years ago, where the doctor assumed his patient had a benign condition but she actually had a strep infection brewing that would have been easily treated with penicillin. I discuss lessons from that case about communicating with your doctor in my book, "The Life You Save."

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June 24, 2012

We Know More About Medical Error and the Harm It Creates … But Not Enough

Twelve years ago, Helen Haskell’s son died because of a series of medical errors. That sad episode prompted her to found Mothers Against Medical Error (MAME), which offers support and advice for people who share such tragedy.

Haskell’s ongoing effort to quantify medical errors and the harm they can cause are detailed in her story on Reporting on Health, an online community for people to share information that fosters better media coverage of health and medicine.

You can’t head off medical harm, Haskell contends, until you can identify its reach. Until 2010, she writes, the primary source cited for the frequency of medical harm in the U.S. was a 1999 report by the Institute of Medicine (IOM). As venerable an institution as it is, the IOM collected data for the report from the 1980s and 1990s--old numbers that didn’t fully offer even a sense of what was happening at the end of that decade, much less more than a decade later.

In addition, the IOM reported only on hospital admissions (see our article, “Hospital Errors” ); but medical harm, of course, occurs in outpatient clinics and surgery centers, in physicians’ offices and nursing home, in dialysis clinics and chemotherapy centers -- wherever medical care is rendered.

In short, while the IOM metrics were solid, they gave an incomplete picture of the impact of medical harm in the U.S.

In 2010 and 2011, Haskell says, new studies were published by the Health and Human Services Department in the New England Journal of Medicine (NEJM) and Health Affairs that advanced the body of harm knowledge.

Employing a system called the Global Trigger Tool developed by the IOM, the studies probe medical records for evidence of potential adverse events. To no one’s surprise, Haskell writes, the newer research found “exponentially greater levels of harm than had been reported earlier by the IOM.

Specifically:


  • more than 1 in 4 hospitalized Medicare patients had suffered an adverse medical event resulting in harm;

  • approximately 180,000 Medicare beneficiaries died every year from their medical care;

  • 1 in 3 patients admitted to three large teaching hospitals suffered medical harm, often more than once;

  • nearly 1 in 5 patients in 10 North Carolina hospitals experienced at least one adverse medical event;

  • a commonly used adverse event detection method—voluntary reporting and the Agency for Healthcare Research and Quality’s Patient Safety Indicators--was poor; it missed 9 in 10 of the events (Global Trigger Tool found at least 10 times as many confirmed, serious events).


The 1999 report, Haskell reminds, was considered a wake-up call for the health-care system to come to grips with the extent and repercussions of medical errors, but the newer studies showed that from 2002 to 2007 there was no significant change in the rate of harm.

The researchers concluded, “Though disappointing, the absence of apparent improvement is not entirely surprising. Despite substantial resource allocation and efforts to draw attention to the patient-safety epidemic on the part of government agencies, health-care regulators and private organizations, the penetration of evidence-based safety practices has been quite modest.”

This “modesty” was quantified:


  • only slightly more than 1 in 100 U.S. hospitals have implemented a comprehensive system of electronic medical records;

  • only 9 in 100 have even basic electronic record-keeping;

  • physicians-in-training and nurses routinely work hours in excess of what’s proved to be safe;

  • compliance with even simple interventions such as hand washing is poor in many centers.


That’s bad, but, as Haskell notes, we still don’t know how bad—or even if it’s less bad—because the most recent numbers crunched in the newest studies date from 2008; the least current numbers come from 2004. That’s better than numbers from the 1980s, but it’s not the most revealing information. Much has changed since the 1990s, but the tired data don’t tell us what changes increase estimates of harm, and what changes decrease them.

In the intervening years, medicine has become more corporate and more consolidated. Bottom-line pressure has intensified. The incidence of medical encounters has increased, but most occur outside of hospitals, where safety isn’t tracked.

In summary, our collective attention about medical errors and the harm they do has been piqued. But that’s only half the job of actually addressing and minimizing them.

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June 20, 2012

Yard Spray to Prevent Lyme Disease Flunks Out

Lyme disease, a bacterial illness transmitted by the bite of a deer tick, is a major health concern in the Northeast and Mid-Atlantic regions. Health agencies are keen to prevent it, but some people believe that a government program to do so might be worse than the illness. The story is another example of how seemingly good ideas in medicine don't always pan out.

As reported last month in the Baltimore Sun, hundreds of Baltimore-area families who volunteered for a government study to spray their suburban yards with pesticide might be at risk. The chemical in the spray, bifenthrin, is classified by the Environmental Protection Agency (EPA) as a possible carcinogen.

Critics of the program note that the EPA is studying bifenthrin for possible harm to reproductive and immune systems. They say that prospective volunteers weren't well enough informed about the potential long-term health risks from being exposed to the pesticide.

Lyme disease can cause fever, headaches, fatigue and, if untreated, can affect the joints, nerves and heart. It’s nasty business. But, say critics of the three-state study underwritten by the Centers for Disease Control and Prevention (CDC), so is exposure to a dangerous pesticide.

Half of the families who signed up for the study have the edges of their yards sprayed with the pesticide commonly applied around homes to fight ticks, fleas and mosquitoes. The others’ yards are sprayed with water. The residents don’t know if they’re recipients of chemicals or mere H2O.

Dr. Clifford S. Mitchell of the state Department of Health and Mental Hygiene explained the study. "The question is, does it actually prevent a common, sometimes severe disease — and second, what's the lowest dose you can do?"

Jay Feldman of Beyond Pesticides, a nonprofit that works toward eradicating toxic pesticides, says that federal and state health officials have not adequately informed volunteers about all the potential health risks. "It's improper to be conducting a human experiment like this."

The Sun reports that an EPA analysis of bifenthrin cites nearly 1,300 incidents involving the pesticide from 2002 to 2009. Most were of "low severity," but even low amounts of the chemical can cause skin and respiratory irritation and dizziness.

The agency classifies it as a possible carcinogen based on rat exposure studies. It also has listed bifenthrin among a group of pesticides to be tested for their potential to act as "endocrine disruptors," which may affect humans or wildlife, even at low doses.

According to the CDC, 30,000 cases of Lyme disease were reported in 2010, most in the regions of study. Health officials believe that doctors often miss or don't report cases, so the actual number could be significantly higher.

Study volunteers were recruited via fliers mailed to residents in ZIP codes with a high incidence of Lyme disease. They sought people who were willing to have a "single, no-cost, commonly used pesticide application" to their yard and answer "short surveys" about ticks and their yards.

Health officials advised study participants not to walk in the sprayed area for 24 hours and to keep pets away. The chemical is highly toxic to aquatic life, so no yards within 100 feet of water are being tested. They say the study and the volunteer information was approved by state and federal review boards whose function is to safeguard people participating in research.

So, does bifenthrin work?

Preliminary results for all three states from the first year of the study indicate that the yards treated with pesticide had 62 percent fewer ticks overall than the yards sprayed only with water.

But residents of the treated households found just as many ticks on their bodies as the residents of untreated properties. And—here’s the money stat—essentially the same number of Lyme disease cases were reported in both groups.

Health officials say that if a second year’s analysis yields no difference in tick bites or infection between the two groups, they'll advise the public that spraying yards with pesticide doesn't help prevent Lyme disease.

But critics say such an outcome — discouraging more pesticide use — would not justify the risks the human subjects assumed. Said one, “We have no idea if we've caused more harm than good.”

According to the National Institutes of Health, (NIH) symptoms of Lyme disease begin days or weeks after infection.

They are similar to the flu and may include:


  • body-wide itching;

  • chills;

  • fever;

  • headache;

  • light-headedness or fainting;

  • muscle pain;

  • stiff neck;

  • a "bull's-eye" rash, a flat or slightly raised red spot at the site of the tick bite. Often there is a clear area in the center. It can be quite large and expanding in size.


If the disease isn’t treated at this stage, it can progress and express more dire symptoms, such as facial paralysis, joint and speech problems, heart palpitations and numbness.

To prevent Lyme disease, the NIH recommends taking precautions to avoid direct contact with ticks. Be extra careful during warmer months. Also:


  • Avoid wooded or bushy areas, or areas with high grasses and leaf litter.

  • Walk in the center of trails.

  • Check yourself and your pets frequently during and after your walk or hike.

  • When walking or hiking in wooded or grassy areas, spray all exposed skin and your clothing with insect repellant.

  • Treat clothing, such as boots, pants, and socks, with a product containing permethrin, which remains protective for several washings.


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June 5, 2012

Safe Injection Practices Are Not a Shot in the Dark

Too many people are being exposed to life-threatening infections because clinicians fail to follow safe practices when administering medicine by injection or infusion.

According to a recent study in Medical Care, the journal of the American Public Health Association, at least 130,000 patients were put at risk between 2001 and 2011 for pathogens including hepatitis and HIV.

As the Centers for Disease Control and Prevention (CDC) noted in response to the study, “In this age of high-tech care, it is difficult to imagine that these types of basic infection control breaches still happen.”

The study showed that exposure to dreaded viruses was the result of reusing syringes, reusing and mishandling medication vials, containers and insulin pens and narcotics theft.

Specifically, the CDC says that disease transmission occurs most commonly from:


  • using the same syringe to administer medication to more than one patient, even if the needle was changed or the injection was administered through an intervening length of intravenous (IV) tubing;

  • accessing a medication vial or bag with a syringe that has been used to administer medication to a patient, then reusing contents from that vial or bag for another patient;

  • using medications packaged as single-dose or single-use for more than one patient (single-dose or single-use vials are labeled as such by the manufacturer);

  • failing to use aseptic techniques when preparing and administering injections to prevent contamination (aseptic refers to the manner of handling, preparing and storing of medications and injection equipment such as syringes, needles and IV tubing).


Under the direction of the CDC, the Safe Injection Practices Coalition (SIPC) has compiled a multimedia toolkit for clinicians to educate themselves and their staffs. It’s part of the One & Only (“One Needle, One Syringe and Only One Time”) public health campaign to raise consciousness about injection safety.

Because many health-care providers apparently aren’t aware of how to inject patients safely (or are simply not paying attention), consumers should be assertive about safety when receiving a shot.

If you are a patient receiving an injection or infusion, make sure that the person administering it:


  • does not use the same syringe for anyone else, even if the needle is changed or it’s being injected through an intervening length of IV tubing;

  • does not breach a medication vial, bag or bottle with a used syringe or needle;

  • does not use medications packaged as single-dose or single-use for anyone else;

  • always uses aseptic techniques in preparing and administering the injection.

If you are not in the same room where the medication was prepared, if you were unable to observe that safe injection practices were employed, ask. If the answer is unclear or insufficient, refuse the medicine and request that it be newly prepared while you observe.

In 2011, a jury in Las Vegas, Nevada found two drug companies liable for damages to victims of hepatitis C infection because they knowingly sold multi-use vials of the anesthetic proposal to a clinic that used the drug in an unsanitary way. The infections could have been prevented with single-use vials. The plaintiffs were represented in that case by Rick Friedman, co-author with Patrick Malone of the "Rules of the Road" books for plaintiffs' lawyers.

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May 29, 2012

Can Baby Boomers Pass the Hepatitis C Test?

In their youth, baby boomers were perceived as the luckiest generation yet of Americans. But thanks to their unprecedented freedom and the boundary-pushing nature of post-World War II America, boomers disproportionately suffer from something nobody wants: hepatitis C.

As a result, the Centers for Disease Control and Prevention (CDC) is recommending that all baby boomers be tested to see if they are harboring the virus that causes problems, or if they already have been compromised by its presence.

Hepatitis is inflammation of the liver. It also refers to viral infections that affect the liver, most commonly hepatitis A, hepatitis B and hepatitis C. Hepatitis C can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Read more about hepatitis here, and about the threat it presents when caregivers are careless.

Hepatitis usually spreads when blood from someone infected with the hepatitis C virus is transferred into the body of someone who is not, most commonly by sharing needles or other equipment to inject drugs. It used to be spread through blood transfusions and organ transplants, but now the blood supply is more thoroughly screened.

According to the CDC, hepatitis infects 1 in 30 baby boomers (the generation born between 1945 and 1965), or 2 million people. It’s the fastest-rising cause of cancer-related death and the leading cause of liver transplants in the U.S.

Most of the boomers infected with hepatitis C are unaware of it—except for ambiguous problems such as fatigue, it remains asymptomatic until the diseased liver is seriously compromised.

So the CDC has issued guidelines proposing that all baby boomers in the U.S. be tested for the virus with a simple, one-time blood test. If it’s positive, treatment can be available before the virus becomes life-threatening. The CDC says newly available therapies can cure as many as 3 in 4 infections.

Baby boomers represent 3 in 4 U.S. adults infected with hepatitis C, and are five times more likely to be infected than other adults; 15,000 die every year from related illnesses, such as cirrhosis and liver cancer.

The CDC estimates that testing could identify more than 800,000 people who otherwise don’t know they have a life-threatening condition. The agency estimates that testing could save more than 120,000 lives.

Hepatitis C can be either “acute” or “chronic”; the former viral infection is a short-term illness that occurs within six months after someone is exposed to the virus. Usually, acute infection leads to chronic infection. That can result in long-term health problems, or death.

There’s no vaccine, so the best way to prevent hepatitis C is by avoiding behaviors that can spread the disease, especially injecting “recreational” drugs.

To take the CDC’s hepatitis C risk assessment, link here. If your risk is moderate to high, or if you are a baby boomer, ask your doctor for the blood test.

To learn more about the CDC's hepatitis initiative, link here.

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March 29, 2012

Venture Capital for Medicine Moves from Robots to Realism

In medicine, a culture shift may be underway in venture capital, which subsidizes the cutting-edge technology that keeps a culture moving forward.

As reported by Kaiser Health News (KHN) in conjunction with NPR and KQED, for venture capitalists, the bloom is fading from expensive medical gee-whizzery. These days, such deep-pocketed supporters are more in favor of improving medical efficiency than in staking a claim to such glitzy endeavors as robotic surgery, whose questionable benefits we recently covered.

Hospitals love boasting about their amazing new machines and surgeons love using them. Insurance companies don’t love paying for them, so their enormous costs are passed along to employers and patients.

As the recession took hold, however, and the Affordable Care Act (ACA) was passed, the financial engine behind high-tech R&D began to reassess where to put its fuel. As one Silicon Valley venture capitalist told KHN, “If you come in with [a device] that’s 10 percent better and twice as expensive, it’s hard to get anyone to care.”

Venture capitalists look for opportunity wherever it occurs, and these days it’s in areas such as helping hospitals figure out how to reduce readmissions. It’s expensive when a recently released hospital patient must be readmitted because of complications, and under the ACA, readmissions carry financial penalties.

Because the ACA will increase the number of people who are covered by high-deductible insurance plans, venture capital is funding a technology company that helps them choose the least expensive care. Another less-than-glamorous funding recipient, but one with an enormous impact, addresses the often torturous process of health-care billing.

“There’s a half a person per hospital bed on average that sits in the hospital doing coding and collections and trying to get paid,” according to one venture capitalist. His solution is to replace the labor-intensive manual coding with software that can understand repetitive charges and devise efficiencies that minimize repetitious functions.

That doesn’t mean new medical developments are all about process instead of product, but the products are simpler. Infections, notoriously borne by the widespread use of catheters, are being controlled better through the venture-capital development of a plastic device that kills microbes. The DualCap catheter costs less than a dollar.

Sometimes, the most thoughtful investment isn’t about the sexiest new surgical tool that helps 10 rich people find a place in medical history; it’s about helping millions of average patients gain access to competent, affordable care for the long run.

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February 6, 2012

Promoting Honest Counting of Hospital-Acquired Infections

Progress is being made in the national effort to let patients know which hospitals do the best job in preventing infections. But patient safety advocates are worried that some of the early reports of hospital-specific data may be overly rosy because of fudging in the way that infections are counted.

Last week we wrote about how infections acquired from intensive care units are more dangerous for children than adults. Most hospitals have made progress in addressing the issue of infection control, and a report issued recently by the Department of Health and Human Services promotes transparency in that effort.

HHS compared hospital ICUs across the country in terms of central line associated bloodstream infections (CLABSIs), which research shows are highly deadly but highly preventable with good care. The information for each hospital is posted on the federal Hospital Compare website, updated quarterly. In the future, infections in addition to CLABSIs will be included.

The Centers for Disease Control and Prevention (CDC) estimated that 18,000 patients developed CLABSIs in the ICU in 2009. As many as 1 in 4 of these patients die. The CDC death toll for all hospital-acquired infections is estimated at 100,000 annually; such infections might cost as much as $45 billion.

Consumer advocates, including the Safe Patient Project of Consumers Union, lobbied for years to enable a hospital infection-tracking system. That organization estimates that 2 million patients a year contract an infection in the hospital.

Since January 2011, hospitals have been required to report ICU-acquired CLABSIs to the CDC in order to receive payment from Medicare. Most states that require infection reports use the same system.

As part of the national campaign, a recent California report was rosy: According to California Watch, rates of infections from catheters are nearly half the national average. But there’s a caveat here that other states embrace as well: Hospitals might be under-reporting the incidence of infections. State authorities are reviewing results of an in-depth infection-reporting audit of four types of infections reported by 100 hospitals. But a lack of funding compromises its ability to fully vet all hospital-generated reports.

As Consumers Union noted, the new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) “pay-for-reporting” program for all patients, not just those covered by Medicare. Most U.S. hospitals participate because their Medicare payments are higher.

To determine how well your hospital stacks up in the infection-control department using Hospital Compare, Lisa McGiffert of Consumers Union advised comparing its rank with the national benchmark. “If your hospital is no different than the national benchmark, that means too many patients are still suffering and dying from infections that could have been prevented with better care,” she said. “The benchmark for success that hospitals should be striving to reach is zero.”

Reports on surgical site infections will begin in 2013. The CDC estimates that such infections account for 1 in 5 hospital-acquired infections. Catheter-associated urinary tract infections also will be tallied as of 2013.

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January 18, 2012

FDA Curbs Use of Antibiotics in Animals

Given our propensity to pop an antibiotic at the first sign of a sniffle—and much of the medical establishment’s willingness to gratify this often unwise habit—it’s hard to believe that the use of antibiotics to fight infection has been common practice for only a couple of generations.

Like all medications, they come with risks of side effects, but in the right circumstances, antibiotics are truly wonder drugs. They’re so wonderful, however, that we overuse them. The problem then becomes not just one of risky and/or unpleasant side effects, but of reduced efficacy.

The more frequently antibiotics are used, the better bacteria become at resisting them. It’s simple evolution—survival of the fittest bacteria. The fitter (stronger) the bacteria, the more compromised the antibiotics. In order to keep up with the demand of increasingly resistant bacteria, new compounds must constantly be developed. The old ones simply don’t work anymore.

Antibiotic resistance occurs when humans ingest the drugs more frequently and for disorders they are not meant to address. But one contributor to this diminishing-effects scenario is not the direct result of human behavior—it results from the routine use of antibiotics in agriculture. They’re given to livestock to prevent disease and promote growth. That practice has been called into question often in recent years.

As explained in the Los Angeles Times, last year, the American Medical Association (AMA), the World Health Organization (WHO) and other medical groups warned that “the misuse of antibiotics in food animal production may be creating a serious problem for human health by fostering development of drug-resistant bacteria."

Further, some studies showed that taking antibiotics out of animal feed "made antibiotic-resistant bacteria less prevalent in both animals and people with no ill effects for animals or ranchers."

Earlier this month, the FDA put its foot down on some unapproved uses of antibiotics for livestock. The agency prohibited use in certain animals of one class of antibiotics called cephalosporins, and prohibited using the drugs for purposes other than their original intent (called “off-label” or “extra-label” use) except for animals that are rarely consumed by humans.

It wasn’t the first time the FDA attempted to curb the use of antibiotics in animals. In 2008, the FDA made a move to limit off-label antibiotic use in livestock, but wussed out in the face of opposition by agricultural interests.

Congressional Rep. Louise Slaughter (D-N.Y.) is a microbiologist who has written legislation addressing antibiotic overuse. In a statement about the latest action, she said, "We need to start acting with the swiftness and decisiveness this problem deserves. With over 1 million Salmonella cases in the U.S. each year, at least 30,000 Americans will contract cephalosporin-resistant bacteria every year. I'm glad the FDA is finally acting but how many Americans have needlessly been sickened in the meantime?"

The new rules take effect April 5, but as in 2008, there’s a comment period in the interim. Comments received last time helped sway the FDA against enforcing the restrictions. So if you care about antibiotic resistance, you might want to weigh in about the latest proposal. Link here to read a Q&A about general antibiotic use in animals and specifically this action. To submit comments, link here and include the docket number FDA-2008-N-0326.

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January 9, 2012

Two Steps Forward, One Step Back for Patient Safety in Hospitals

There’s been a lot of good news lately about what hospitals are doing to protect patients: Many have improved their infection control practices, many are looking at the value of “hospitalists” (doctors who practice exclusively with inpatients) and many have embraced palliative care.

Yet for every two steps forward for patient safety, it appears as though many hospitals are taking at least one step back. As reported last week in The New York Times, a federal report concluded that hospital employees recognize and report only 1 in 7 errors, accidents and other events that harm Medicare patients.

An even more shocking revelation in the report by Department of Health and Human Services investigators is that once hospitals do investigate preventable injuries and infections, they seldom change their practices to thwart them from recurring. This despite the fact, as HHS Inspector General Daniel R. Levinson pointed out, that Medicare reimbursements to hospitals are contingent on them tracking such errors and adverse events, analyzing and addressing them.

“Adverse events” are those that cause significant harm experienced by patients as a result of medical care.

As the Times reported, “Despite the existence of incident reporting systems,” Levinson said, “hospital staff did not report most events that harmed Medicare beneficiaries.” And, he said, some of the most serious problems, including some that caused patients to die, were not reported.

The report found that “hospitals made few changes to policies or practices” even after employees reported harm to patients. In many cases, hospital executives told federal investigators that the events did not signify any “systemic quality problems.”

Among the problems enumerated were:


  • medication errors;

  • severe bedsores;

  • hospital-acquired infections;

  • delirium caused by overuse of painkillers; and

  • excessive bleeding linked to improper use of blood thinners.


Levinson estimated that more than 130,000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month, and that many hospital administrators knew that hospital staff were underreporting them.

Whereas once hospital employees were afraid to admit mistakes for fear of reprisal, that doesn’t seem to be the problem here. Rather, Levinson said, it’s that hospital employees don’t recognize “what constitutes patient harm,” nor do they realize that certain events harm patients and should be reported. And sometimes they just assume someone else will report the episode, they believe it to be so common as to be insignificant or they assume it is an isolated event unlikely to be repeated.

For more information about hospital errors, and what you can do about them, see this page on our website.

In response to the confusion described by the HHS report, Medicare officials said they would develop a list of “reportable events” hospital employees could use to eliminate questions about what’s required and what isn’t. In addition, the Medicare agency said, hospitals should give employees “detailed, unambiguous instructions on the types of events that should be reported.”

You mean they haven’t already done so?

Article first published as Two Steps Forward, One Step Back in Hospital Patient Safety on Technorati.

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December 5, 2011

Doing Hospital Care in the Home

Unless the patient needs really intensive, round-the-clock care, most hospital-type care can be done in the patient's home -- where it's safer, more comfortable and less expensive. That lesson is so well accepted that it was written into the federal health care reform law -- to provide financial incentives for outfits called Independence at Home Organizations.

The problem is that the rules for the new home care organizations are supposed to go into effect on January 1, 2012, but Medicare is behind on writing the rules. So there will be delay in getting this started. The current rules discourage moving hospital-style care home because, among other things, Medicare won't pay for home visits.

An internist named Jack Resnick, M.D., writing an op-ed in the New York Times, talks about his own practice on New York City's Roosevelt Island, caring for infirm and elderly patients. He makes a persuasive case for the home care organizations, writing:

Patients who are treated at home by a doctor and nursing staff who know them intimately and can be available 24/7 are happier and healthier. This kind of care decreases the infections, mistakes and delirium, which, especially among the elderly, are the attendants of hospital care. And it is far more efficient.

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November 17, 2011

Curing Infectious Diarrhea with Fecal Bacteria

Yes, you read the headline correctly. Transplanting feces from healthy patients into patients with horrible infectious diarrhea is rapidly becoming standard medical practice because of its dramatic positive results.

Contracting an infection from Clostridium difficile (C. difficile) can be deadly. About 6 in 100 hospital patients become infected with the insidious bacterium. People who use proton-pump inhibitors also seem to be at greater risk factor for infection. So says a recent study published in the New England Journal of Medicine.

The study’s authors hope that its findings will promote efforts to prevent this extremely common cause of health-care related infectious diarrhea.

A day after that study hit the news, their wishes seem to have come true.

In a “say what?” solution to the horrors of C. difficile infection, the American College of Gastroenterology reported that transplanting fecal material containing healthy bacteria into C. difficile patients can bring relief even to elderly, debilitated people for whom previous courses of treatment had failed.

As reported on MedPage Today, 9 in 10 “fecal microbiota” transplants were successful. The definition of success was patients who had no recurrence within three months. On average, it took six days for their diarrhea to resolve, and four weeks for their fatigue to resolve.

What seems contrary to common sense – even physicians posting comments on the MedPage story were making bathroom humor jokes – appears to be the new gold standard of care for C. difficile infections. Stool bacterial population of patients with recurrent C. difficile infections, apparently, is completely different from that of normal people. “Therefore,” the study’s lead author said, “it would make sense that if you performed a massive bacterial replacement, that might very well reverse that condition and allow for a cure in people who were otherwise not curable.”

The study is poised to change how gastroentologists – physicians who specialize in disorders of the the stomach, intestines and associated organs – practice.

C. difficile infections are notoriously difficult to treat. Recurrence rates are as high as 1 in 2 patients. Earlier fecal transplant studies showed promise, but their results were derived from only a single treatment center. The new study involved five different U.S. medical centers.

The patient/subjects involved in the new study, according to MedPage Today, had failed an average of five different medication courses before receiving the transplant.

At the risk of someone claiming “too much information!” the question arises: What was the source of the transplanted material? More directly, who were the donors? Most were members of the same household as the patient; only one patient had no relationship with the donor.

One interesting result was that two patients experienced improvement in their pre-existing conditions; one with arthritis and one with sinus allergies. Four patients developed new disorders – peripheral neuropathy (nerve damage involving numbness and pain in hands and feet), Sjogren's syndrome (an immune problem involving various symptoms), rheumatoid arthritis and idiopathic thrombocytopenia (abnormally low blood platelets of unknown origin). One patient, who was in hospice care, died.

Study subjects did not seem to find the idea of a fecal transplant unpleasant. "They're desperate people seeking desperate measures so they didn't have much of a problem with it,” said the study’s primary author. “We have to stop thinking of stool as a smelly inert substance; it's an incredibly biologically active substance."

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October 26, 2011

Cellphone Hazards: Radiation? Maybe; Germs? Big Time

When you get up close and personal with your cellphone, what are you exposing yourself to, literally? Dangerous radiation? Maybe. Nasty germs? Most certainly.

Two studies examining different potential hazards of cellphones have been in the news lately. One concerns the ongoing debate about the radiation risks of extended close contact with your phone, and the other concerns its hospitality to surface germs.

The first study involved members of the advocacy group Environmental Health Trust and was published in the journal Electromagnetic Biology and Medicine. It says that exposure measures per FCC guidelines underestimate how much radiation most people receive from their cellphones, according to a story in the Los Angeles Times.

The study authors say that current assessment methods use a large, liquid-filled plastic model of the adult human head, but that more than 9 in 10 people have smaller heads and therefore higher proportional exposure than what is assessed. Most important, children receive twice as much microwave radiation to the head as adults, the study estimates, and 10 times the amount to bone marrow.

Not to mention the possible exposure to other body parts when, say, a phone is stowed in your pocket.

The scariest possible side effect of cellphone use is brain cancer, although whether microwave radiation from cellphones can damage DNA and cause cancer is a subject of debate. See the National Cancer Institute fact sheet.

The Electromagnetic Biology and Medicine paper requests that the cellphone industry use a different method to certify phones for use, one that considers different sizes of users, and those who are pregnant.

A Danish cellphone study found no relationship between cellular telephone use and the incidence of cancer, but the British Medical Journal found problems with some aspects of that study.

Bottom line, there are passionate researchers on both sides of this issue and we really have no definitive science to argue conclusively that cellphones do or do not pose a radiation risk. As in most things, moderation is in order. Use cellphones only as necessary, and store them, ideally, away from your body.

In contrast, it's unequivocal that your phone goes with germs like peanut butter goes with jelly.

As reported on WebMd, 9 in 10 cellphones in a United Kingdom study served as host to bacteria including E. coli. And the reason is simple: People don’t wash their hands after using the toilet.

In this study, the E. coli came from fecal bacteria, which can survive on hands and surfaces for hours.

The researchers studied cellphones in 12 cities across the U.K. and asked users about their hand hygiene. Here’s what they learned:


  • 9 in 10 phones were carriers of bacteria

  • 8 in 10 hands were carriers of bacteria

  • 16 in 100 hands and 16 in 100 phones bore E. coli bacteria.


Still, nearly everyone said they washed their hands with soap where possible, leaving the researchers to conclude that people tend to lie about hygiene habits.

If dirty hands are touching cellphones, they’re also touching other surfaces. Said one of the researchers: “They're spreading fecal bugs on everything they touch really."

"We didn't ask people whether they'd used their phones in the toilet. That might be something that would be interesting to study," she said.

Well, interesting is an interesting word, but it definitely would be illuminating, probably in ways most people don’t want to know.

Wash your hands. Often. It’s really just that simple.

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October 5, 2011

When a Doctor's Talking Too Much Makes the Patient Go Blind

The headline is no joke. It's what experts think is the explanation behind vision-ruining infections in the eye that happen occasionally with injections into the eye of a drug used to halt the progress of macular degeneration.

As the thinking goes, if the doctor is talking during the time he or she is drawing the drug from the vial into the syringe, tiny droplets of the doctor's saliva can then be transmitted into the patient's eye.

Another cause of eye infections in patients who get these injections is less than sterile conditions in the pharmacies that take a single vial of the drug and divide it up into the tiny doses for individual eye patients.

Whatever the cause, the infections known as endophthalmitis happen in about 1 in 1,000 injections of both of the commonly used drugs for the wet form of macular degeneration: Avastin (also used in cancer treatment) and the far more expensive Lucentis.

Read this New York Times piece for more on the subject, and about how a raft of publicized cases of infections with Avastin seems to be driving much of the eye injection business to Lucentis despite its higher price -- $2,000 a dose compared to only $50 a dose for Avastin.

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September 13, 2011

The Dirt on Hospital Uniforms

It’s enough to make you want to shrink-wrap yourself in your hospital bed.

A report published in the American Journal of Infection Control concluded that as many as 6 in 10 uniforms worn by hospital caregivers tested positive for potentially dangerous bacteria.

Swabs of the uniforms of 75 RNs and 60 M.D.s at a 550-bed university-affliliated hospital yielded cultures containing multidrug-resistant germs including methicillin-resistant Staphylococcus aureaus, or MRSA – also known as the “super bug.”

That’s not a compliment.

According to AboutLawsuits.com, MRSA infections represent more than 60% of hospital staph infections, and the Centers for Disease Control and Prevention tally some 126,000 hospital MRSA infections every year, resulting in about 5,000 deaths. Some researchers believe that the number of deaths every year from MRSA in the U.S. is about 20,000 if community-acquired infections are included.

As you might imagine, the number of infection-related lawsuits filed against hospitals also has increased in recent years.

Even if the clothing itself does not present an immediate risk of disease transmission, the results are disturbing for what they reflect about antibiotic-resistant strains in close proximity to hospital patients — the people most vulnerable to contracting disease.

The key message here for hospital staff isn’t necessarily to wash your uniform; it’s to practice what every thinking health caregiver has been preaching for years: Wash your hands.

“Any clothing that is worn by humans will become will become contaminated with microoganisms,” said Russell Olmsted, president of the Association for Professionals in Infection Control and Epidemiology. “The cornerstone of infection prevention remains the use of hand hygiene to prevent to movement of microbes from these surfaces to patients.”

The World Health Organization pegs the risk of health care-associated infection in some developing countries at as much as 20 times higher than in developed countries like the U.S. But they’re still relatively common here, they can be deadly and they are expensive to treat. Prevention is the only way to guarantee patient safety.

As we’ve reported before, if you or a loved one is scheduled for a hospital stay, ask in advance for a copy of the facility’s infection prevention and control program. And if a hospital or clinical caregiver forgets, don’t be too timid to ask that person to wash his or her hands before attending to you.

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September 1, 2011

Hospital Safety: Hazards to Patients Spelled Out in Pictures

Check out this graphic display of some of the statistics of hospital hazards. Infections, malpractice, errors due to poor record keeping, medication errors, mistakes due to sleep deprivation of trainee doctors: It's all displayed here, courtesy of a group called Medical Billing and Coding Certification.

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August 30, 2011

Hospitals Prove Infection Control Works

It’s an unfunny truism that if you want to avoid getting sick, stay out of the hospital. But that may be starting to change for the better.

The unacceptably high number of hospital patients who contract an infection after admission has long been in the news. We have covered the topic frequently.

According to federal estimates, 1 in 20 people admitted to a U.S. hospital develops an infection – or about 1.7 million people every year. Such infections represent a top 10 cause of death in this country; approximately 99,000 people die annually from hospital infections, at a health-care cost of $33 billion.

Scrutiny of this problem has generated policy changes – Medicare, for example, no longer foots the bill when inpatients are infected by microbes from catheters and intravenous lines. And, per the new federal health-care legislation (the Affordable Care Act), soon subsidies will be withheld to hospitals that fail to reduce their infection rates.

In a bit of good news from this patient safety front, many hospitals have committed to solving the problem and boast demonstrable results. As reported in the Los Angeles Times, a three-year campaign to reduce the incidence of hospital infections in California has saved lives, cut costs and institutionalized best practices to ensure continued vigilance and good results.

At the midway point of the campaign, the program has seen reductions of:


  • ventilator-associated pneumonia by 41%;

  • catheter-related urinary tract infections by 24%;

  • blood poisoning by 11%.

About $11 million has been saved, and about 800 lives.

The health threat is particularly acute these days, thanks to the increasing use of outpatient clinics. That means hospitals are reserved for the sickest patients, and the sicker the patient, the more vulnerable he or she is to infection.

In California, Anthem Blue Cross is often the target of consumer and health advocates who have challenged its substantial health-care premium increases and its history of questionable recissions (dropping policyholders from coverage after the discovery of an expensive medical condition). But even this often soulless corporate entity acknowledges the unacceptable cost of hospital infections, and has funded the statewide Patient Safety First program with $6 million.

The company says it has recouped nearly double its investment in the program through reduced health-care spending. And its corporate parent, WellPoint, Inc., says it won’t increase payments to hospitals in 14 states that don’t meet its standards of infection control, readmission rates and other practices.

Some of the program elements employed by hospitals are:


  • establishing and following safety checklists and documenting every step;

  • frequent hand-washing by staff;

  • more frequent brushing of patients’ teeth;

  • enlisting respiratory therapists to swab the mouths of patients on ventilators several times a day;

  • eliminating unnecessary procedures.

If you or a loved one is to be admitted to a hospital, ask if it has an infection-control checklist, and if so, ask to see it. After admission, make sure staff members wash their hands before they tend to you or your loved one. Ask when catheters and ventilators were last sanitized. Hospitals that care about your safety should not object to such scrutiny

As Dr. James Cleeman, an expert on health-care quality, told the L.A. Times, “Nobody should go into a hospital and wind up sicker than when they went in.”

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July 24, 2011

Guidelines to Prevent Infections in the Doctor's Office

Hospitals are subject to clear standards and procedures for infection control, but germs don't care whether they live in an operating room or a medical office exam room.

The Centers for Disease Control and Prevention (CDC) do. It recently issued "Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care" for all manner of ambulatory care centers, including doctors' offices and outpatient testing and lab facilities.

Among the most basic practices such facilities should follow are:


  • Develop and maintain infection prevention and occupational health programs.

  • Assure sufficient and appropriate supplies necessary for adherence to standard precautions (hand hygiene products, personal protective equipment, injection equipment).

  • Assure at least one individual with training in infection prevention is employed by or regularly available to the facility.

  • Develop written infection prevention policies and procedures appropriate for the services provided by the facility and based upon evidence-based guidelines, regulations, or standards.



Patients generally are not aware, nor should they be, if their health-care providers have undergone the necessary training to adhere to these guidelines. But they're common sense, and if anything seems amiss when you visit your doctor--say, the nurse doesn't wash her hands before offering a thermometer--ask what measures are being taken to protect you from someone else's germs.

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May 11, 2011

‘Superbug’ deaths spur probe into prostate biopsies

As an increasing number of patients being tested for prostate cancer contract potentially lethal drug-resistant infections, some physicians are rethinking their approach to prostate cancer screening.

Several studies released in the past year reveal that infectious complications from biopsies have more than doubled in less than a decade, and a growing percentage of patients who undergo needle biopsy tests are becoming critically ill and dying from bacterial infections, including sepsis.

A tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder. The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream.

If the bacteria is resistant to antibiotics given at the time of the biopsy, the routine, 15-minute procedure can turn into a dangerous situation.

More than 1 million transrectal prostate biopsies are done in the U.S. each year to diagnose cancers in men whose screening blood tests suggest they may have the disease, but no studies have examined the risk of sepsis globally. Instead doctors are trying to gauge the scope of the problem from studies beginning to emerge from North America, Europe and Asia.

For example, a research team at the Odette Cancer Center in Toronto uncovered the emerging infection risk last year after examining more than 75,000 electronic records of biopsy patients treated in Ontario between 1996 and 2005.

The team discovered that the chance of being hospitalized within a month of the procedure had increased fourfold in less than a decade, reaching 4.1%in 2005 from 1% in 1996; of these, 72% were diagnosed with infections.

Source: Bloomberg News

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May 10, 2011

Hospital scrubs: "Fashionable" but a suspected source of infection

You see them walking around hospitals, and sometimes even on the street: health care workers wearing surgical "scrubs." It's something of a fashion statement, but also a potential carrier of infections, yet no one has really carefully studied the problem to know for sure.

The old adage among patient safety advocates that “you can’t improve what you don’t measure" describes what we know about infection rates in hospitals. As long as little or no data on infection rates are collected, the problem tends to be sidelined.

There is no data about a possible link between hospital scrubs worn outside the operating room and infection rates. Scrubs can carry harmful pathogens, and because the transmission modes of drug-resistant pathogens are more prevalent than previously thought and are no longer confined to hospitals, some patient safety advocates say it’s time hospitals addressed the issue.

One such group, the Empowered Patient Coalition, which works on patient education and empowerment issues, wants hospitals and other health care organizations to start by gathering data on scrubs in their facilities and by looking at the data about the types of pathogens that are found, and then developing policies to keep both their workers and the public safe.

But, the group says, for such a policy to be effective, a hospital would have to:

1-Promote a culture where the policy is the norm, not an additional burden.

2-Communicate the policy efficiently to staff using supervisors who believe in the action.

3-Ensure that ignoring the policy will have consequences and would be considered an employment standards issue.

Source: University of Southern California Reporting on Health

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April 16, 2011

A Gentler Option to Barking: "Did You Wash Your Hands?"

Hospitalized patients are right to be terrified of getting a serious infection from the hands of their doctors or nurses. But is there any option to barking at everyone who comes in your room: "Did you wash your hands?"?

Yes, says gastroenterologist Steven Kussin, author of the forthcoming book “Doctor, Your Patient Will See You Now.”

Here's the problem Dr. Kussin identifies if you ask the "did you wash your hands" question:

Doctors or staff members who respond “no” are guilty of a grave medical lapse. If they didn’t wash and then lie to you, they’re also guilty of a grave ethical lapse. Either way, the question raises their defenses and their hackles. Instead, if you didn’t witness a hand-washing ritual, then assume it didn’t happen. You’ll probably be right. Physician hand-washing compliance runs about 33 percent.

And his answer, in a letter to the editor in the New York Times:

If you show them, they will wash. When they, or anyone, approach your bedside, give them notice of your intent. Hold out a bottle of sanitizer with a big smile. As you squirt them say: “I know how busy you are, and I am sure you’ve already done this a million times a day. But I’m terrified of those infections I’ve been reading about. I hope you’re O.K. with this.”

That’s it. Easy, pleasant and effective.

Good advice. I have more about avoiding infections in the hospital, and other avoidable medical harms, in my patient safety newsletter, which you can read here.

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April 12, 2011

As much as 45% of all U.S. health care costs due to medical errors, studies show

Medical mistakes account for between 18 and 45 cents of every health care dollar spent in the U.S., and a medical error or adverse effect occurs in one out of every three hospital admissions, researchers say.

According to studies published in the journal Health Affairs, the single most expensive cause of harm is infection after surgery, with more than 252,000 infections costing $3.36 billion reported in 2008, while pressure ulcers (bedsores) are the most common preventable event, with with nearly 375,000 cases in 2008 costing $3.27 billion.

Following a shocking 1999 report that showed that as many as 98,000 people die annually due to medical mistakes, hospitals have tried to reduce such adverse effects, but serious mistakes persist. In 2006, for instance, medical mistakes contributed to as many as 187,135 deaths and 6.1 million injuries that cost between $393 billion and $958 billion.

“There are some examples of excellence; we have many [intensive-care units] that have eradicated central line infections. But surrounding those examples of excellence we have serious adverse events going on,” said Dr. Mark Chassin, president of the Joint Commission, a nonprofit organization that accredits health care programs. “Every week in the United States, up to 40 patients undergo a procedure meant for somebody else or the wrong body part,” he said.

The costliest medical errors were:

1. Infections after surgery (252,695 in 2008, cost $3.36 billion)

2. Pressure ulcers - Bedsores (374,964 in 2008, cost $3.27 billion)

3. Complications from noncardiac implants and grafts (60,380, cost $1.07 billion)

4. Complications from lower back surgery (113,823, cost $1 billion)

5. Excessive bleeding complicating a procedure (78,216, cost $680 million)


Source: National Journal

You’ll find more information about the Health Affairs studies here.

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March 8, 2011

Fewer central line infections in ICU, but not in other wards

The number of bloodstream infections in intensive care units (ICUs) caused by tubes inserted into major blood vessels decreased significantly between 2001 to 2009, but unacceptably high rates of infection are still occurring for patients in other hospital units and for dialysis patients, government researchers say.

Central lines are tubes that are usually placed in the large veins of the neck or chest to deliver medicines and nutrition. Infections of these lines, which are largely preventable, can become serious problems, with death rates of 12-25%.

An estimated 18,000 ICU central-line infections were recorded in 2009, down from 43,000 in 2001, according to a report by the Centers for Disease Control and Prevention (CDC). This 58% decrease means that in 2009, between 3,000 and 6,000 deaths were prevented and as much as $414 million saved. And if the decrease in these ICU infections was steady from 2001 to 2009, as many as 27,000 lives and as much as $1.8 billion may have been saved.

(Note: These numbers are rough estimates. The 2001 figure of 43,000 infections could have been as low as 27,000 and as high as 67,000.)

According to the CDC, much of the decrease resulted from campaigns to improve techniques for managing the lines in ICUs, where they are most frequently used. Infections involving bacteria such as staphylococcus can be avoided with simple measures like washing hands, wearing sterile gowns and drapes, and following the proper techniques for inserting and maintaining the lines.

However, researchers noted that central line infections still occurred far too often, affecting 80,000 patients a year and killing at least 10,000. In addition, of the 350,000 patients who received dialysis in the U.S. in 2008, about 37,000 suffered central-line infections. Such infections are the second leading cause of hospital stays and death in people on dialysis after cardiovascular problems.

Peter Pronovost, MD of Johns Hopkins Hospital, a pioneer in patient safety, developed the simple "checklist" for using central lines in ICU patients, which was proven in a landmark study in the New England Journal of Medicine to cut the infection risk to close to zero.

Source: The New York Times

You can read an abstract of the study here.

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February 24, 2011

Maryland's Hospital Infection Effort Includes Financial Penalties

The state of Maryland is putting some financial sting in its efforts to get hospitals to lower the number of patients who contract deadly infections while hospitalized.

Nine hospitals are being fined a total of $2.1 million for having higher than usual infection rates.

The hospitals are: in the Washington, DC area: Prince George's Hospital Center, Shady Grove Adventist, Montgomery General, Doctors Community and Washington Adventist, plus University of Maryland Medical Center in Baltimore, St. Joseph Medical Center in Towson, Civista Medical Center in La Plata and Memorial Hospital in Cumberland (now part of the Western Maryland Health System).

Twenty-three hospitals - including Holy Cross, Howard County General, Suburban Hospital and Johns Hopkins in Baltimore - did better than the state average and will receive small bonuses.

The list of all hospitals included in the survey and their infection rates for fiscal year 2010 can be found by clicking here and then click on this line on the web page: Hospital Infection Related PPC Rates, FY 2010.

The state's effort is more ambitious than just infections. It follows a set of 49 PPCs: Potentially Preventable Complications. It sets up payment incentives and fines to encourage hospitals to reach goals of making patient care safer.

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February 10, 2011

Ohio hospitals save $13 million by cutting infections

More than two dozen hospitals in Ohio that collaborated to reduce hospital infections and drug mix-ups saved $12.8 million in health care expenses by doing so, according to a recently released report. The Solutions for Patient Safety initiative, launched by a coalition of business and hospital groups in January 2009, included 17 hospitals acute care hospitals and eight children’s hospitals.

The report said hospitals were able to achieve the changes by sharing successful data-collection techniques and best preventive medical practices with one another.

Seventeen central Ohio hospitals cut methicillin-resistant Staphylococcus aureus (MRSA) infections by 42% and catheter-related central line associated bloodstream infections (CLABSI) by 37%, thereby avoiding an estimated 918 patient days in the hospital and preventing 14 deaths. Meanwhile, the eight children's hospitals cut surgical infections by 60% and adverse drug events by 35%, preventing more than 3,500 children from being harmed while in the hospital and saving $5.3 million in medical costs.

Two processes - hand hygiene and "scrubbing the hub" - emerged as critical to significantly reducing infection rates for MRSA and CLABSI. Hand hygiene was the primary area of focus for the collaborative’s efforts to reduce MRSA infections, and an inverse relationship between hand hygiene and incidence of MRSA was observed. Since the beginning of hand hygiene data collection by specially hired observers in September, the rate of compliance with washing hands upon entering and leaving a patient’s room, even while wearing gloves, has improved by more than 20 percent. For CLABSI related infections, the observers identified a critical point of infection transmission related to the length of time the “hub” (the access point in a catheter where fluids and medications are administered) is cleaned.

Source: American Medical Association News

You can read the report here.

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December 14, 2010

Blood sugar monitors: One to a patient, if you want to avoid infection

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning healthcare professionals that sharing blood glucose monitoring machines carries the risk of transmitting the hepatitis B virus (HBV) and other infectious diseases. Their simple advice: One monitor per diabetic patient.

In recent years, the number of reported HBV outbreaks linked to blood glucose monitoring has increased, particularly in nursing homes and assisted-living facilities, but also in any setting (e.g. clinics, health fairs, schools, camps and senior centers, among others) where blood glucose monitoring equipment is shared, or where those performing the monitoring do not follow basic infection control practices.

While stressing that reusable fingerstick lancing devices should never be used for more than one person to avoid the risk of transmitting bloodborne pathogens, the FDA and CDC also maintain that the glucose meters themselves can also pose an infection risk, since it can be difficult to ensure that blood has been completely removed from these devices. They point to a 2005 multicenter survey that indicated that 30% of blood glucose meters used routinely in the surveyed hospitals had detectable blood on their surfaces.

Therefore, the FDA and CDC advise that whenever possible, blood glucose meters should be used for one patient only. Otherwise, meters should be cleaned and disinfected after every use to prevent carry-over of blood and infectious agents. In addition, hands should be washed and gloves changed between patients.

Source: FDA Patient Safety News

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October 27, 2010

Alarm sounded over drug-resistant bladder bacteria

Infectious disease specialists are raising the alarm over a variant of the e.coli bacteria that is resistant to most of the antibiotics used to treat bladder infections and could be responsible for more than 3,000 deaths a year.

E.coli ST131, an aggressive strain of multi-drug-resistant e.coli bacteria, may be responsible for as many as 1 million bladder infections a year, according to a recent study conducted by Dr. James Johnson, an infectious disease expert at the Veterans Affairs Medical Center in Minneapolis.

E.coli ST131 is one resistance gene away from being untreatable, Johnson warns. “I think it’s high time to worry. Before, resistant strains were wimpy. Now, we have a winner,” he says.

Although e.coli is best known as the intestinal bacteria that causes diarrhea when people eat tainted meat or vegetables, such as spinach, it actually occurs more often outside the intestines, causing far more infection and death. Extra-intestinal e.coli is responsible for about 80 percent to 90 percent of the urinary tract infections that occur annually.

Most e.coli variants respond to common treatments: guzzling gallons of water, swilling quarts of cranberry juice, and, if all else fails, heading to the doctor for a quick course of antibiotics. However, Dr. Johnson’s study determined that although the e.coli ST131 strain accounted for only about 17 percent of e.coli isolates overall, it accounted for more than 50 percent of bacteria resistant to more than one antibiotic, including the top two types used to treat most urinary tract infections, or UTIs, and also was responsible for nearly 70 percent of resistance to the biggest guns of mainline UTI treatment, fluoroquinolones and extended-spectrum cephalosporins.

E.coli ST131 probably caused the most significant multi-drug resistant e.coli infections in the U.S. in 2007, the year Johnson studied, constituting a serious public health threat.

Dr. Johnson’s findings add to the growing concerns about drug-resistance in common infections such as UTIs. New UTI guidelines that will restrict the use of fluoroquinolones for large infections are expected to be issued by the Infectious Diseases Society of America this fall.

Source: MSNBC
You can read an abstract of Dr. Johnson’s study here.

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July 30, 2010

Hospital Infections: Discouraging Words from a Patient Safety Pioneer

Infections in the large-bore tubes that keep patients in intensive care units alive are often lethal but readily preventable. A simple checklist of sanitary practices was proven to cut the rate of these "central line infections" to nearly zero. But that was in one chain of hospitals in Michigan. What about the rest of the country?

Peter Pronovost, the Johns Hopkins safety guru who ran the study in Michigan proving that these infections could be eliminated, was given big grant money by the U.S. government and private foundations to spread the learning to the other 49 states. So what has he found? Here's an excerpt from what he wrote recently in the Journal of the American Medical Association:

Hospital enrollment in the program has been surprisingly slow. In many states, less than 20% of hospitals have volunteered to participate. Some hospitals have reduced infection rates, most have not. Some hospitals claim they use the checklist, despite having high or unknown infection rates. Some hospitals are content to meet the national average, despite evidence that these rates may be reduced by half. Some hospital administrators say their patients are too sick; these infections are inevitable. Yet, intensive care units in several large academic hospitals have nearly eliminated CLABSIs [central line infections]. Some hospitals blame competing priorities for their inattention to these infections. If these lethal, expensive, measurable, and largely preventable infections are not a priority, what is?

Perhaps most concerning is the response from nurses in participating hospitals when asked: "if a new nurse in your hospital saw a senior physician placing a catheter but not complying with the checklist, would the nurse speak up and would the physician comply?" The answer is almost always, "there is no way the nurse would speak up." Doubly disturbing, physicians and nurses uniformly agree patients should receive the checklist items. What other industry would
accept a routine safety violation that is associated with the deaths of tens of thousands of patients and not be held accountable? The US health care culture still does not support the questioning of physician behavior.

That last sentence is perhaps the most chilling -- because it shows, once again, that many patients are going to be doomed to preventable injuries and death until the medical culture begins to change, and doctors get off their pedestal and join the rest of the team trying to keep patients safe.

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January 8, 2010

Another Good Clue that Your Hospital Takes Infection Prevention Seriously -- Chlorhexidine

Memorize the name of this antiseptic wash and make sure your hospital uses it: chlorhexidine.

Research continues to pile up that diligent but inexpensive efforts by hospital staff can greatly cut the annual toll of an estimated 100,000 lives lost to hospital infections. The latest simple step involves greater use of the antiseptic chlorhexidine to wash patients before surgery.

In two studies reported in the New England Journal of Medicine, post-surgical infections were cut dramatically when either of two steps were taken:

* Disinfect the patient's skin just before surgery with a chlorhexidine-alcohol rub -- instead of the usual iodine prep.

* Have the patient shower for several days before surgery with a chlorhexidine-based soap, like Hibiclens.

Read more on this antiseptic at Wikipedia.

See Pam Belluck's article in the New York Times for more details on the new studies.

My book, "The Life You Save," lists simple ways patients can help reduce their risk of getting infections in the hospital, including chlorhexidine soap. So the latest studies are only confirming the wisdom of this advice. But because many hospitals don't yet do this, you should ask questions and make sure they have plenty of chlorhexidine on board.

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January 8, 2010

Fighting Hospital Infections: When Less is More

The deadly MRSA infection, estimated to kill 19,000 Americans every year (more than the toll from AIDS), has been virtually wiped out in Norway, with three simple steps:

As described in a recent Associated Press article:

Norway's model is surprisingly straightforward.

-- Norwegian doctors prescribe fewer antibiotics than any other country, so people do not have a chance to develop resistance to them.

-- Patients with MRSA are isolated and medical staff who test positive stay at home.

-- Doctors track each case of MRSA by its individual strain, interviewing patients about where they've been and who they've been with, testing anyone who has been in contact with them.

Step No. 1, ratcheting back on antibiotic prescriptions and relying more on the old tried-and-true ones, won't go over well in America, where the prescription drug industry pushes all of us into a newer-is-better and more-is-better approach.

But step No. 2 -- test and isolate -- has been proven to work by itself to virtually wipe out the spread of MRSA once it gets into a hospital, by isolating people who are carriers.

The problem is that people can carry the bug on their skin without harm; a deadly infection only happens when it gets into the body of an already vulnerable patient. The answer: do nasal swabs of all incoming patients when admitted to the hospital to see if they are carriers, and if so, isolate them in special units.

Does your hospital do this? If not, you should ask why not. The safest hospitals in the United States do nasal swabs of all incoming patients at the time of admission. It's for their safety and everyone else's.

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October 8, 2009

Infection Control: A Hospital Executive Speaks Out

The CEO of Beth Israel Deaconess Medical Center in Boston is speaking out about his hospital's efforts to prevent deadly infections. The question is: How come few other hospital executives are talking about their efforts? Are they not making vigorous efforts? Or are they obsessed with secrecy, as so many in the medical industry are?

Paul Levy posted his hospital's numbers on reducing "central line" infections -- the infections that patients in ICUs get in the large-bore tubes that have to be inserted to monitor activity in the heart and deliver medicines to really sick people. When these infections occur, the already sick patient often dies. Pioneering work by Dr. Peter Pronovost proved that rigorous hand washing and other sanitation practices can reduce these infections to close to zero.

Mr. Levy is justifiably proud of Beth Israel's hard work at getting its infection rate down. But he wrote a blog entry that talked about his disappointment that others have not joined in. Here's an excerpt:

The response to my public and private entreaties in this realm has been silence -- from hospital professionals, from insurance executives who care about a transformation of this industry, and, indeed, from public advocacy groups who care about access to care and the quality of care delivered. Some observers attribute the medical profession's lack of engagement to an underlying fear of transparency. And yesterday, a world expert in this field, whose wisdom and advice I treasure, told me that he has come to accept gradual progress in quality and safety improvement, citing the kind of training doctors get, which does not emphasize these areas. That such a person has become content with gradual changes in the status quo is an indication of what it must be like to beat your head against this wall of recalcitrance for several decades.

My advantage, being without medical training and having had but a short tenure in this field, is that I retain a sense of outrage. Our collective failure to approach this problem using well established methods of process improvement -- including publication of current performance results -- represents a moral and ethical lapse by the clinical and administrative leadership of the medical establishment in this city. Why? Simply put, a profession that takes an oath to do no harm is, by inaction or incomplete action, doing harm. We are causing people to die who should not die. What would we call that if we saw it happening in other sectors of society?

Here's the full blog entry, which has comments below it.

I learned about Mr. Levy's blog from Consumer Union's excellent blog at their Safe Patient Project website.

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August 7, 2009

Saving Lives -- and Money Too -- With Patient Safety Reform

A new report from Public Citizen proposes 10 cost-cutting, patient safety measures that would save an estimated 85,000 lives and $35 billion a year. The report, "Back to Basics," analyzed the results of scientific studies of treatment protocols for chronically recurring, avoidable medical errors.

In contrast to the high-tech tests and procedures that many experts blame for staggering increases in the nation’s health care costs, most of the reforms in Public Citizen’s report involve fundamentals as simple as practitioners consistently washing their hands, sufficiently tending to patients to prevent bed sores, and following simple safety checklists to prevent infections and complications stemming from operations.

Many of the proposals on Public Citizen's list are the same that I discuss in my book, "The Life You Save." The only difference is that I believe patients and families can do their own health care reform at home to implement many of these safety measures. I discuss examples of things patient advocates can do at the bedside to help prevent pressure ulcers (bed sores), injuries from falls, blood clots, infections and medication errors. See Chapter 12: "Your Personal Advocate, in the Hospital and Out," and Chapter 13: "The Scandal of Infections in Hospitals and Other Health-Care Facilities, and What You Can Do."

Here is more from Public Citizen's news release announcing their new report.

Aside from the tragedy of needless deaths and injuries, the financial toll of failing to follow accepted safety procedures is astounding. Severe pressure ulcers cost an average of $70,000 apiece to treat. A catheter infection costs $45,000. Each instance of ventilator-associated pneumonia costs $5,800. Collectively, avoidable surgical errors cost an estimated $20 billion a year, bed sores $11 billion and preventable adverse drug reactions $3.5 billion.

"There are many incentives to order expensive tests and procedures and too few rewards for providing basic, sensible care," said David Arkush, director of Public Citizen’s Congress Watch division. "As the largest investor in the nation’s health care system, the federal government should ensure that fulfilling basic patient safety standards is a condition of receiving federal reimbursements. And the government should pay providers for doing the right thing. It will save money in the long run."

Public Citizen proposes that health care providers:

• Use a checklist to reduce avoidable deaths and injuries resulting from surgical procedures (saves $20 billion a year);

• Use best practices to prevent ventilator-associated pneumonia (saves 32,000 lives and $900 million a year);

• Use best practices to prevent pressure ulcers (saves 14,071 lives and $5.5 billion a year);

• Implement safeguards and quality control measures to reduce medication errors (saves 4,620 lives and $2.3 billion a year);

• Use best practices to prevent patient falls in health care facilities (saves $1.5 billion a year);

• Use a checklist to prevent catheter infections (saves 15,680 lives and $1.3 billion a year);

• Modestly improve nurse staffing ratios (saves 5,000 lives and $242 million a year);

• Permit standing orders to increase flu and pneumococcal vaccinations in the elderly (saves 9,250 lives and $545 million a year);

• Use beta-blockers after heart attacks (saves 3,600 lives and $900,000 a year); and

• Increase use of advanced care planning (saves $3.2 billion a year).

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August 6, 2009

Broken Alarms and False Alarms in Medical Testing -- the Swine Flu Problem

Swine flu testing is the latest example of an important issue for informed patients. Patients need to understand that some medical tests are valuable if there is a "positive" finding, but not much good at all if they are "negative." The problem is that the test is "insensitive," which means a negative result can miss the disease that's really there -- a "broken alarm."

For swine flu, in every 100 patients who actually have flu, the various brands of "rapid flu" tests will have a "positive" result (meaning the patient has the flu bug) for as few as ten of the 100 patients, or as many as 69 of the 100 patients. Even with the higher accuracy, that means that a lot of patients are being missed by these "rapid flu" tests. These statistics come from a New York Times article quoting newly published studies and experts in the field including the Centers for Disease Control and Prevention.

A CDC official told the Times:

“We’re saying you need to understand the limitations of these tests,” Dr. Timothy M. Uyeki, an author of the C.D.C. guidance, said in an interview. “The clinician should not base a decision to treat or not treat on the basis of a negative result.”

Another classic example of an "insensitive" test is the "hemoccult" test for hidden blood in the stool. If it's positive, you need further workup. If it's negative, it doesn't give you a clean bill of health for colon cancer. That's why the standard screening test for colon cancer is a colonoscopy, which looks at the entire length of the colon with a video camera.

My book "The Life You Save" has a chapter about understanding medical testing and why you cannot necessarily rely on a negative test result.

The point is: A negative result doesn't mean you have a clean bill of health. Sometimes you have to pay attention to other signs and symptoms.

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July 10, 2009

How Can We Reduce Hospital Infections?

Several letters to the editor in the New York Times have good thoughts on the critical topic of reducing hospital-acquired infections. It's important not just to exhort hospital administrators to try harder, but to set up incentives that reward safety and punish harm. One incentive not discussed in these letters is a national mandatory disclosure system. That would require hospitals to measure and publicly report all their infections. Consumers would then be able to make intelligent decisions about which hospitals to seek care at.

As previously discussed in this blog, Consumers Union has been advocating such a disclosure system for several years and has made headway in various states, but a national system is needed.

Chapter 13 in my new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, talks about, as the chapter title says: "The Scandal of Infections in Hospitals and Other Health-Care Facilities, and What You Can Do." Patients and family members can do a lot to enforce hygiene rules and avoid infection.

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July 7, 2009

Thousands Exposed to Hep-C by Rogue Surgery Tech

The news from Colorado that a drug-addicted surgery technician had exposed thousands of patients to the Hepatitis-C virus raises questions about the institutions' procedures for protecting patients.

According to news accounts, the surgery tech, Kristen Parker, swapped her dirty syringes, filled with saline, for clean ones filled with Fentanyl, in operating rooms at Rose Medical Center in Denver and Audubon Ambulatory Surgery Center in Colorado Springs. That way she could steal Fentanyl, a powerful morphine-based drug that is used for surgical anesthesia, and inject it into herself to feed her drug habit. Ms. Parker has just been charged in a federal criminal complaint.

The institutions are sending certified letters to 4,700 patients at Rose and 1,000 at Audubon advising them to get tested for Hepatitis-C. That's because Ms. Parker tested positive for Hepatitis-C, and several patients already have tested positive.

Hepatitis-C is a virus that causes chronic liver infection in about 75 to 85 of every 100 persons who get an acute infection. A few of those who get chronic infection go on to develop cirrhosis or liver cancer. There is no known cure for Hepatitis-C infection.

The Colorado Springs Gazette reports:

Parker worked at Rose from October 21, 2008 until April 2009. She resigned on April 20 from Rose, but the hospital refused to accept her resignation and instead fired her.
She went to work for Audubon shortly after being fired from Rose. She worked there from May 4 until Monday, said Dr. J. Michael Hall, Audubon's medical director.
Hall said certified letters are being sent to all patients who had outpatient surgery at the center's Circle Drive and Union Boulevard location May 4-July 1 advising them they may have been exposed and with instructions on what to do.

Surgical technicians are not licensed health care providers. Yet because their job involves preparing operating rooms for surgery, they have access to powerful drugs, so it's foreseeable the job can attract addicts. A similar incident occurred in Washington, D.C., a few years ago, where a tech at a major hospital was caught swapping out syringes filled with powerful pain reliever drugs for plain salt water so that he could inject himself with the narcotic drugs.

According to the Gazette:

Prior to being hired at Rose, she [Ms. Parker] submitted to a pre-employment blood test which tested positive for hepatitis C. She was allowed to start work but hospital officials counseled her about the disease and exposure possibilities.
Rose placed her on administrative leave following an incident in which a co-worker was pricked by a needle in Parker's pocket on March 23, 2009.
According to the affidavit, Parker quickly disposed of the needle and denied any use of narcotics. She was allowed to return to work after a drug screening test came back negative.
The hospital placed her on administrative leave again after a co-worker reported seeing Parker in an operating room to which she was not assigned. She was tested again for drugs and this time the results were positive for Fentanyl.

The questions yet to be answered include:

1. Why hire someone positive for a contagious disease like Hepatitis-C and give them access to needles which can spread the disease?
2. Why not fire her the first time she was found with a needle?
3. Why did the second institution hire her so quickly after she was fired by the first? Were references checked? Shouldn't she have been required to advise the surgery center who her most recent employer had been?
4. Should there be a central data bank so that health care employers can find out about fired or disciplined employees, so they cannot easily travel from job to job? There is such a data bank for licensed health care workers, but perhaps it should apply to unlicensed ones as well.

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May 22, 2009

Is Our Health Care System Safer Today than 10 Years Ago?

A new report from Consumers Union says too many patients are still dying every year from needless errors. The report makes a number of proposals for how reforms could be instituted to improve patient safety. A starting point will be to change the health reform debate in Washington from one of just access and money to one focusing on quality and safety.

Nearly 10 years ago, the Institute of Medicine estimated that nearly 100,000 people died each year from preventable medical error. Has there been any substantial improvement in the last decade? The Consumers Union report says the frustrating answer is "We don't know" -- because systems to methodically measure and report harm are still not widely in place.

What should consumers push for?

* A national system with mandatory reporting of all infections acquired in health care facilities and other harms from preventable errors.

* More widespread adoption by hospitals of computerized systems for ordering and dispensing drugs to cut medication errors.

Those are the key steps called for by the Consumers Union report. Here's one more that I advocate in my new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst -- a "single payer" system. How would having a government-paid health care system help with safety? For starters, it would allow much easier monitoring of quality and errors. Instead of cobbling together data from dozens of insurance companies about how patients did at a particular hospital, all the data would be centralized and could be easily analyzed and compared. That way, problems with care could be more easily identified before tragedies occur.


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April 2, 2009

Pistachio May Be Linked to Salmonella Contamination

Salmonella, which causes serious gastrointestinal illnesses that can be life-threatening, was found in pistachios last week, according to the Los Angeles Times. The FDA has issued warnings for consumers to stop eating all foods containing pistachios, while investigations are underway.

Although salmonella contamination in pistachios is yet to be confirmed, Setton Pistachio of Terra Bella Inc., the nation’s second-largest pistachio processor, has voluntarily recalled more than 2 million pounds of nuts that it shipped out last fall. Kraft Foods Inc. and Kroger have also recalled some of their pistachio products.

Consumers are advised to stop eating pistachio products and monitor the investigations as more reports become available.

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October 22, 2008

Online Anonymous Notification of Sex Partners For STDs

An online service called inSPOT allows patients who test positive for STDs to use a website to notify sexual partners, anonymously if they so choose, of the possibility that the partners were infected. A report done by the San Francisco Department of Public Health finds that since 2004, 30,000 people have used the service to send 50,000 notifications of all sorts of diseases contracted through sexual activity.

This project has enormous potential health benefits because embarrassment and a desire to remain anonymous are factors that can prevent people from notifying past sexual partners of their risk of contracting the disease. Of course, as Dr. Richard Rothenberg of Georgia State University notes in the article, it is difficult to track the effects of the project because of confidentiality issues. Nevertheless, the project is valuable:

However, it may be difficult, if not impossible, to study the impact on health because the service is confidential, Rothenberg said. "I think we, and the authors, must be content with the idea that this appears to be an acceptable method to fulfill the moral imperative of notification, and it has a chance to be a better approach than what we currently do," he said.

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July 15, 2008

Adults Slack on Vaccinations

Laura Landro, in her column "The Informed Patient," discusses the problem of adults neglecting to get vaccinated for new illnesses. Not only that, but adults forget or are unaware that some childhood vaccinations lose efficacy after some time and need to be re-done. Skipping pre-travel vaccinations is also a common error.

Part of the problem is insurance: not only is vaccination for the very young more likely to be encouraged, but it is also more likely to be covered by insurance providers.

The whole column is worth a read, but here are some disturbing statistics Landro cites:

-only 2.1% of adults are vaccinated for tetanus, diphtheria and whooping cough, despite the existence of a combination vaccine for all three.

-only 1.9% of adults have been vaccinated for shingles. The shingles vaccine is recommended for all adults over 60.

-only 10% of women from 18 to 26 have received the vaccine for human papillomavirus, which can lead to cervical cancer, and which most insurance providers will cover.

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February 8, 2008

Advocacy Groups Seek Repeal of Needle Exchange Laws

One-third of new HIV cases in the U.S. are due to injection drug use, and HIV/AIDS has decimated the African-American community in particular. That is why it is no surprise that the NAACP and other advocacy groups chose Thursday--which was National Black HIV/AIDS Awareness Day--to call on Congress to repeal a ban on federal funding for needle exchange programs. There is some political controversy over this ban, because many politicians are afraid to look like they are supporting drug use, but public health advocacy groups are generally in favor of repealing the ban because of the demonstrated effects of needle exchange programs.

A quote from a supporter of repeal from the article:

Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, on Wednesday said that he supports needle-exchange programs. In a separate statement, Fauci said the high rates of HIV/AIDS among blacks require "drastic action." He added, "In particular, black leaders -- religious, secular and political -- have a key role to play in reducing the stigma often associated with HIV/AIDS and influencing African-Americans to get tested, counseled and treated" (Crary, AP/Seattle Times, 2/6).

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January 16, 2008

MRSA Transmittable Through Some Sexual Activity

MRSA or methicillin-resistant staphylococcus aureus, a "superbug" infection usually contracted in hospitals, is now being transmitted during male-male sexual encounters. This news comes just a few months after MRSA was discovered in some Virginia schools. As the linked pages note, MRSA is highly drug resistant and can be deadly. It comes in many strains and is often difficult to treat, requiring expensive antibiotic regimes. The discovery of MRSA in schools and among sexually active gay men is disturbing because it indicates that this "superbug" is no longer an exclusively hospital-based phenomenon and may start becoming more common in the general population, where researcher Binh Diep says it would be "unstoppable."

In San Francisco, researchers found that sexually active gay men were 13 times more likely to have MRSA than sexually active heterosexuals. It is passed on in the same way as other sexually transmitted diseases: unprotected and skin-abrading sex.

The best way to avoid getting MRSA in any fashion is through simply practicing good hygiene and washing with soap and water. This is why, as this blog has discussed before, it is vitally important for healthcare professionals to wash their hands before examining or treating patients.

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December 11, 2007

Checklists to Save Lives in the ICU

An article in the New Yorker by Atul Gawande highlights the simple ways in which hospitals can be made less dangerous places for their patients. A checklist to make sure intensive care doctors and nurses handle catheters correctly has been proven to dramatically reduce the risk of deadly infections. Gawande focuses on the work of Peter Pronovost, MD, an intensive care specialist at Johns Hopkins Hospital who consults with hospitals around the country to spread his gospel of routinizing simple procedures. For example, on catheter infections, Pronovost's work was first published in December 2006 in the New England Journal of Medicine. In 108 ICU's across Michigan, they were able to virtually wipe out catheter-based infection by enforcing a required checklist of five interventions: hand-washing before handling a catheter, full-body draping when inserting a central venous catheter, scrubbing the skin with chlorhexidine, avoiding catheters in the groin, and removing unneeded catheters as soon as possible. All hospitals should implement these simple ideas which can prevent deadly infections and save lives. Dr. Pronovost is a pioneer in patient safety research.

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October 29, 2007

MRSA Discovered in Virginia Communities: What You Need To Know

Recently, a 17-year-old in Bedford County, Virginia died of an infection known as MRSA . MRSA stands for “methicillin-resistant staphylococcus aureus” and is also referred to as a “staph infection” or a “superbug.” MRSA is a particular kind of staph infection that is resistant to common antibiotics. The MRSA bacteria was found in many other schools in Virginia as well as over the country, and Bedford County schools were closed down as a result.

These developments are unusual and surprising because MRSA generally turns up in hospitals, rather than in schools or other places in the community.

Things to know about MRSA:

1)It is spread through skin-to-skin contact. Alternately, it can be spread through surfaces or objects that many people have touched or through personal items such as towels.

2)MRSA is easy to prevent but can be difficult to cure. Basic hygiene is the number one factor in preventing this infection. Hand-washing is especially important. Other factors include keeping personal items clean, using disinfectants and being careful about use of antibiotics. Overuse of antibiotics is what prompts bacteria to evolve into resistant strains.

3)As most MRSA cases occur in hospitals, it is important to be especially vigilant about the hygiene about those around you if you or a loved one is admitted to the hospital. Do not be shy about asking if doctors, nurses, or other caretakers have washed their hands. Lack of such basic measures has led to deaths in the past, as can be seen by examining the case of Maureen Daly and others.

Another useful resource are these FAQs about schools, kids and MRSA.

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