Patient Safety Blog

In a study published this week in The Lancet, a British research team found that surgical stockings given to stroke patients for prevention of blood clots do not work, reports Sam Lister of UK’s Times.

The compression stockings provide graduated pressure and should reduce swelling in the legs. Studies have shown that, for patients immobilized after surgery, these stockings effectively reduce formation of blood clots, which can be deadly when the clots travel up to the heart or lungs and obstruct blood flow.

However, in the new Lancet paper, scientists followed 2,500 stroke patients in Britain, Italy and Australia, and found that the use of compression stockings made no significant difference in the occurrence of DVT (deep vein thrombosis, the blood clots in the deep veins of the legs that can travel to the heart or lungs). Patients who wore the stockings actually suffered additional symptoms that include skin breaks, ulcers and blisters.

The results of the study were also presented at the European Stroke Conference on May 27 in Stockholm. Researchers believe this study conclusively shows compression stockings should not be recommended to stroke patients.

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Posted In: General , Standard of Care--Hospitals , Surgery

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Acetaminophen, the unpronounceable name for the active ingredient in Tylenol, is the most widely used pain reliever in the United States. But it can destroy the liver in ordinary or near-ordinary doses. That fact is news to many consumers but is old hat to liver specialists who every week treat patients at death's door from acute liver failure due to acetaminophen.

It has now been documented that acetaminophen is the most common cause in the U.S. of acute liver failure, which can result in death if a liver transplant cannot be done.

The Food and Drug Administration has recognized that acetaminophen poisoning is a public health issue and has slowly taken steps to educate the public to this popular drug's dangers. In April 2009, the FDA mandated a new warning label, which will say on 500-mg products (Extra Strength Tylenol and its generic equivalents): “Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than eight tablets in 24 hours, the maximum daily amount.” It will also warn against using it with other acetaminophen products or with alcohol use of three or more drinks a day. The FDA rejected a request from the Tylenol manufacturer McNeil to water down the warning by removing the word “severe” and adding the word “overdose,” which the agency said could lead consumers to believe they had to greatly exceed the recommended dosage before jeopardizing their livers.

This warning won't take effect until spring 2010. FDA advisors first recommended such a liver warning in 1977.

In the meantime, an FDA advisory panel will meet in late June to consider other steps intended to make it harder to accidentally cause liver failure from taking too much acetaminophen. A "working group" of advisors has recommended among other things:

• limiting the single adult dose to a maximum of 650 mg, and limiting tablet size to 325 mg (down from the current extra-strength size of 500 mg and single dose of 1000 mg);
• lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (and less than that for chronic alcohol users);
• restricting pediatric liquid formulations to a single mid-strength concentration;
• eliminating acetaminophen from combination products.

You can read the working group's recommendations at the FDA's web site here.

In the 1990s, Patrick Malone was one of the first attorneys in the United States to successfully sue the Tylenol manufacturer for hiding the dangers of acetaminophen from doctors and the public. Read about his case of Benedi v. McNeil here. Watch the ABC Prime Time Live segment on this subject by clicking here.

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Posted In: Medications , Product Safety , Self-care

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When someone over age 55 develops memory problems, it is often diagnosed as Alzheimer's, or another type of dementia, or perhaps Parkinson's disease, all of which are progressive and non-reversible. But families should be aware of one condition that can masquerade as any of these but if accurately diagnosed, can be treated successfully. The condition is called normal pressure hydrocephalus, or NPH, and as Jane Brody reported in the New York Times, because it is so frequently missed, no one is sure how many people have it, but estimates are up to 375,000 people in the United States.

Hydrocephalus involves a buildup of pressure inside the brain from lack of drainage of the cerebrospinal fluid that bathes and cushions the brain and spinal cord. Every person makes about two soda cans' worth of the fluid every day, and if it is not reabsorbed into the blood stream, pressure can build and cause damage to nerves and structures inside the brain.

Typically NPH presents first with a walking disorder -- the victims walk slowly with feet wide apart. It then progresses to urinary incontinence and loss of memory. These three issues are considered a "classic triad" for NPH.

If NPH is suspected, imaging of the brain will reveal one or more enlarged ventricles, the holes inside the brain that are filled with cerebrospinal fluid. The treatment is to put a tube into the ventricle to drain off the accumulated fluid and divert it into the abdomen. This surgically implanted shunt is reported to benefit 70 to 80 percent of patients with NPH. The manufacturer of a programmable shunt has a web site with more information: www.lifenph.com.

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Posted In: General , Misdiagnosis

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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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Posted In: Communication , Disclosure , Infections , Medical Error

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Time was when you had to pay a lot extra to get a private room in a hospital, and the single room was thought to be a luxury for patients. But now research has been accumulating that the private room can play a big role in safety: cutting the risk of infection, helping the patient sleep better at night, reducing the risk of medication mixups, and to boot, making for the kind of real privacy that the Orwellian-termed "semi-private" room does not allow.

In most new hospital construction in the United States, the patient rooms are single-bed, and many of them have other features that promote safety and comfort: like having plenty of room for a family member to stay in the room (so they can act as a patient advocate), and placing a sink near the door to encourage caregivers to wash hands and reduce infections. The American Institute of Architects has called for single rooms in new hospital design since 2006.

These and other features of safety-oriented hospital design are discussed by Carol Ann Campbell in an article in the New York Times.

Another important feature of safe design is placing nurses stations within line of sight for the patient rooms.

Patients who have a choice of hospitals should look to these kinds of issues when deciding what hospital offers the best prospects of safe, high-quality care.

The importance of having an advocate with you at all times in the hospital, how to look for a quality hospital and how to take steps to reduce risk of infections in the hospital are discussed by Patrick Malone in his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Standard of Care--Hospitals

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Starting July 1, Vermont residents will be able to learn exactly how much money any doctor in that state is receiving from the drug and medical device industry. The state is also banning most gifts like free meals to doctors, nurses, pharmacists and other health care providers.

This is an important step forward in eliminating the conflicts of interest that plague use of prescription drugs in the United States.

Vermont already has publicized non-doctor-specific data on drug industry payments intended to influence doctors. Even in a small state like Vermont, the total spent last year was $2.9 million, with most of the money targeted to doctors thought to be influential with their peers. The biggest single payment was $112,000 to a psychiatrist. And the drugs which topped the list for money paid were Strattera, a drug for attention deficit disorder, and Cymbalta, for depression and anxiety.

The new legislation was reported in an article by Natasha Singer in the New York Times.

Doctors and drug companies often deny that free meals and payments of consulting fees have any influence on doctors' prescribing habits. The mere fact that the industry spends hundreds of millions of dollars each year on such marketing suggests otherwise. Commendably, the Vermont Medical Society supported the new disclosure law.

Patrick Malone discusses conflicts of interest and how patients can use drugs -- sensibly, skeptically and safely -- in his new book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Conflicts of Interest , Disclosure , Medications

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Families of active duty military service members sometimes learn too late a shocking fact about the military medical care system: lack of accountability when someone has been injured or killed by malpractice. The latest victim is Cindy Wilson, an Air Force technical sergeant who bled to death after a cesarean section delivery due to an artery that was cut during the operation and not found until she had lost an entire body's volume of blood.

As described in an article by Bill Sizemore in The Virginian-Pilot, after the death of their 37-year-old daughter at Langley Air Force Base, Tommy and Connie Wilson learned about the "Feres doctrine." That is the name of the U.S. Supreme Court decision from 1950 in which the Court ruled that the military was immune from lawsuits concerning injuries to active duty service members caused by negligence of other service personnel, even if that malpractice was egregious.

George Washington University law professor Jonathan Turley was quoted in the article as calling the Feres doctrine "one of the most grotesque rules created in the history of this republic" - because it encourages lack of safety practices in military hospitals.

If military doctors injure someone who is not active duty military (such as a military family member or a veteran retired from service), the government is not immune from accountability. So if Ms. Wilson's baby boy had been hurt during the delivery in which she was killed, the family could have sued for his injuries. But because she was active duty, the government was immune from suit under the Feres doctrine. Because that difference doesn't make sense, a bill is now before Congress to lift the government's immunity from malpractice cases no matter who the victim is.

You can read more about legal issues surrounding military malpractice at a special section of Patrick Malone's law firm web site.

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Posted In: Medical Error

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It sounds like every patient's medical fantasy: Easy access to your doctor 24/7, same-day appointments, thorough and unrushed examinations, little to no time in the waiting room. The only downside is expense: To get this kind of personalized care from a primary doctor, you have to pay an annual fee, and forget about insurance covering it. And you will still need insurance to cover hospital stays and specialists.

Is this ultra-personalized health care, which is called "concierge medical practice," worth it? Many patients think so. Even those squeezed by the recession are often finding room in their budgets for the annual fee for a concierge doctor, even as they cut down on restaurant dinners and other non-essentials.

According to a report by Kevin Sack in the New York Times, leaders in the field of concierge care say they see no impact of the recession in the steady growth of their practices. Dropout rates from the practices are holding steady.

It's estimated there are about 5,000 concierge doctors in the United States, a small fraction of the 240,000 internal medicine doctors in the country. One of the largest groups is called MDVIP, which started in Florida and now has 300-plus physicians in its network. Each MDVIP doctor is limited to 600 patients, who have to pay an annual fee of $1,500 to $1,800. The limit on the number of patients lets the doctors see far fewer patients in a typical day.

The advantage for patients is having a medical expert on hand who knows your body intimately and can sometimes detect subtle danger signs before a full-blown crisis develops.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, finding a top primary care doctor is one of Patrick Malone's key "steps" to finding the best medical care. If it takes extra money to get that relationship, and you can afford it, signing up with a concierge medical practice can be money well spent.

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Posted In: Accessibility of Healthcare , Communication , Doctor-Patient Relationship , Primary Care

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One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in the U.S. is Botox.

Botox and Dysport are injectable drugs developed from botulinum toxins, which temporarily paralyze the muscle into which they are injected. When administered for approved uses at approved doses, the botulinum toxins cause no harm. However, if used improperly, the toxins can travel from the injection site to other parts of the body, causing difficulty with swallowing or breathing.

Approved uses of injectable botulinum toxins include treatments for crossed eyes, eyelid spasms, severe underarm sweating, frown lines, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position.

According to the new FDA requirement, the drug manufacturers not only have to add the black-box warning labels, they also have to inform doctors of the risk information in writing, and make available a medication guide to patients at the time of injection.

Patients are well advised to read all handouts on drugs they take, especially something used for cosmetic purposes. Every drug has risks and must be taken with caution.

Ten rules for safer drug use can be found at Public Citizen's Health Research Group website. These rules and more tips for safe drug use are discussed by Patrick Malone in his book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Disclosure , Medications , Product Safety

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Nobody wants to go home from the hospital only to be readmitted within a few weeks. But that revolving door is very common in conditions like heart failure, where the patient's heart muscle doesn't pump effectively after it has been weakened by heart attack or other heart disease.

The open secret of the hospital industry is that the financial incentives of Medicare and private insurers are tilted toward keeping that revolving door going. Hospitals that actually invest money in following patients after they leave the hospital to try to keep them healthy find that they lose money on this follow-up care. Reed Abelson of the New York Times wrote a report describing how progressive hospitals that have tried to keep their patients from readmission have lost millions of dollars in the process. Those include the Park Nicollet Health Services in Minnesota and Catholic Healthcare Partners in Cincinnati.

One lesson from this story is that patients don't have to wait for medical payment reform to get better care and avoid the revolving door. If you or someone in your family has heart failure, here are the early warning signs that symptoms may be worsening and a doctor or nurse should be called:

* Weight gain. Patients need to weigh themselves every day. Sudden weight gain often means a buildup of fluids caused by the heart not pumping effectively.

* Shortness of breath. Fluid buildup often is most apparent in the lungs and is signaled by being out of breath.

* Ankle swelling. Another place where fluid buildup can be spotted early.

A phone call to the nurse can result in an adjustment of medication that may ease the problem. If that doesn't work, a visit to the doctor's office might be in order. The goal is to intervene before a crisis develops and you have to be rushed to the hospital in an ambulance.

If your doctor already has a system in place that helps you monitor yourself at home, that means you have a top-quality doctor. If you have a hard time getting such a monitoring system going with your doctor, then it might be time to switch to someone who is more responsive.

Patrick Malone discusses how to find a top primary care doctor in his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst

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Posted In: Accessibility of Healthcare , Doctor-Patient Relationship , Heart Disease , Hospitals , Self-care , Standard of Care--Hospitals

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Strokes cause more disability than just about any other disease, but they don't have to. Effective treatments are known for the most common type of stroke; delivering them to the right patients has proven to be difficult. Now a group of researchers is proposing some changes in how stroke care is organized, with the hope of matching reality to the promise and greatly improving stroke outcomes.

In 1995, a landmark study was published showing that the impact of stroke on the human brain could be greatly diminished by using clot-busting drugs to dissolve the clots that kill brain cells in ischemic stroke. (Ischemic stroke is responsible for about four of five strokes. In ischemic stroke, brain tissue dies because blood clots or narrowed blood vessels block flow of oxygen-rich blood to brain tissue. In hemorrhagic stroke, which affects about one in five stroke patients, brain tissue dies because a burst blood vessel causes bleeding in the tissue.)

Today, though, it is estimated that fewer than one in ten victims of ischemic stroke are treated with either intravenous tPA, the main clot-dissolving drug, or other effective treatments, such as breaking up the clot with a mechanical device inserted inside the blood vessel.

The accepted convention is that tPA does not work unless the i.v. is started within three hours of the onset of stroke symptoms. Most patients don't get to the hospital that quickly, and even when they do, time is eaten up by the necessity to give everyone a CT scan to make sure they are not having a bleeding stroke, for which use of the clot-dissolving drugs could be a disaster.

A new article by Drs. Reza Hakimelahi and R. Gilberto González, "Neuroimaging of Ischemic Stroke With CT and MRI: Advancing Towards Physiology-Based Diagnosis and Therapy," advocates these changes to help deliver more of these proven treatments to more patients:

* Doctors need to recognize that the three-hour window for treatment sometimes is much longer in patients who have blockages of smaller vessels in the brain with some temporary compensation through "collateral" vessels. Better imaging studies can identify these patients who have an "ischemic penumbra" that would benefit from clot-dissolving drugs.

* Many patients can benefit, even after the three hours has expired, by direct intervention with mechanical devices to break up clots from the inside of the vessels. Because this requires expertise in interventional neuroradiology, a field with only a few hundred practitioners in the United States, the authors recommend cross-training for doctors in related fields who know how to use tiny tubes inside blood vessels to deliver treatments. These include interventional cardiologists.

* Hospitals that are recognized as expert in care of acute strokes could be divided between advanced and general levels of expertise. On the general level, any such hospital needs to have 24-hour CT scanning and the ability to give clot-busting drugs in the emergency department. To qualify as an advanced stroke center, the hospital would have to have the ability to do interventional treatments inside blood vessels ("endovascular therapy"), a neuro-intensive care unit, and a team of doctors from multiple specialties that work together to decide the best treatment for each patient.

(NOTE: To read this article, you have to sign up for a free membership at Medscape.com.)

As these ideas are debated in the medical industry, the best strategy for patients is to have some advance knowledge and basic planning. Knowing how common strokes are, and how urgent the timeline is ("Time Is Brain" in stroke treatment) once stroke symptoms start, here is what I advocate:

* Know the basic symptoms of stroke, and don't rationalize your way out of a trip to the hospital if the symptoms seem mild or go away after a few minutes. Here is a basic list from the American Stroke Association:
* Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
* Sudden confusion, trouble speaking or understanding
* Sudden trouble seeing in one or both eyes
* Sudden trouble walking, dizziness, loss of balance or coordination
* Sudden, severe headache with no known cause

* Know which hospital in your area has advanced stroke treatment staff and machines. Ask if they have a multi-disciplinary team. (It should include both neurosurgeons and endovascular therapists.) Ask if they have a neuro-intensive care unit (an ICU that treats only patients with brain or spinal cord problems).

* If a loved one suffers stroke symptoms, do not let the rescue squad take them to the nearest emergency room UNLESS the same hospital has advanced stroke treatment abilities.

* A multi-disciplinary team is important because conflicts of interest can drive doctors to advocate for therapy they can do when a safer, more effective treatment might be available from a doctor with different training. Having doctors work together to help the patient and family decide treatment is the best approach.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, Patrick Malone discusses one tragic case in which a patient needed a teamwork approach to her neurological problem but didn't get it because the hospital had no effective team in place. The book discusses the questions to ask to make sure your doctors are working together and not as competitors for your health care business.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Accessibility of Healthcare , General , Medications , Standard of Care--Hospitals

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An Institute of Medicine report released on April 28, 2009, denounces the adverse effects that the health care system suffers from the free gifts regularly pumped into hospitals, medical schools, and doctors’ offices, writes New York Times’ Gardiner Harris. The report strongly advises doctors to stop accepting the gifts. The report says that accepting gifts would “create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy.”

When doctors accept gifts from drug companies – which may be money, drug samples, office supplies or food – they change their prescribing habits. This change may or may not be conscious, but the “reciprocity instinct” that prompts people to return a favor is part of human nature that has been recognized by psychologists and anthropologists. And when this happens, the patients are the real victims: their doctors may prescribe new drugs that are yet to be tested for their safety or effectiveness, or drugs that patients can easily replace with diet or lifestyle changes.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care – and Avoiding the Worst, Patrick Malone discusses steps patients can take to avoid being victims of such conflicts of interest. He also explains how an average patient can dissect statistics on drug performance to determine if a particular drug is really as effective as it’s marketed to be.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Disclosure , Doctor-Patient Relationship , General , Medications

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In its letters sent to 14 pharmaceutical companies in March 2009, FDA required risk information to be included in the Internet search advertisements of drugs – a move welcomed by consumer advocates, reports Stephanie Clifford in a New York Times story.

The short text ads that appear to the right of Google search results are limited to 95 characters, in which space pharmaceutical companies are now required to include not only the drug’s name but also its risk information. Although the drug companies had made risk information available just one click away from the search ads, which linked to a webpage containing detailed information of the drugs including side effects, the FDA issued this new requirement to ensure consumers are not misled.

Rita Chappelle of the FDA said in an NYT interview that it’s “vital and critical” that consumers do not mistakenly believe the drugs to be safer or more effective than they really are. This precaution is especially important in drugs that have frequently occurring or serious side effects, such as depression, liver damage, infections or severe allergic reactions.

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Posted In: Disclosure , Medications , Product Safety

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On May 1, 2009, the FDA issued a warning for consumers to immediately stop using dietary supplements containing Hydroxycut, which has been linked to dozens of serious health problems including jaundice and liver damage. The dietary supplement is also responsible for one death from liver failure. Other reported health problems include seizures, muscle damage and cardiovascular disorders.

Patients who reported health problems were taking recommended dosage of Hydroxycut products, dietary supplements for weight loss. Therefore, the FDA urges consumers to stop taking Hydroxycut products immediately to avoid risks, many of which can involve permanent damage to your health.

The agency also advises consumers to consult a doctor if they experience these symptoms: jaundice (yellowing of the skin or whites of the eyes), brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Manufacturer of the dietary supplement, Iovate Health Sciences of Ontario, agreed to recall the products.

Diet supplements are promoted for their health benefits. Their “natural” ingredients are supposedly safer for a host of benefits like losing weight and gaining energy. The truth is that for most supplements, the benefits are unproven and untested, and the safety of these products is questionable.

Under federal law, diet supplements, unlike drugs, do not have to prove their safety and effectiveness before being sold to consumers. The supplement manufacturers are supposed to keep track of their own safety with very little government oversight until tragedy strikes.

Ironically, though, the diet supplements contain ingredients that mimic the actions of drugs and in some cases even contain actual prescription drug ingredients. Spiking a supplement with any prescription drug is illegal, and the FDA has been on a campaign to identify these products. Since December 2008, it has listed 70 brands of supplements that contained hidden and potentially dangerous drugs.

Another problem is that once reports start coming in of consumers sickened or injured after taking a supplement, it is often hard for safety officials to pin down what ingredient of the supplement was the culprit. Hydroxycut, for example, has a blend of a number of substances, the formula of which has changed over time. And for any of these products, because they are derived from plant materials, the strength can vary from batch to batch.

The best advice for consumers: Don’t be fooled by “natural.” When you’re taking a diet supplement, you are really ingesting a bunch of pharmacologically active substances, some of which won’t hurt you but won’t necessarily help you either. And sometimes, as with Hydroxycut, you can be hurt.

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Posted In: General , Product Safety

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