Archive for the ‘Medication Errors’ Category

July 1 – New Residents, New Rules……Again!

Monday, June 13th, 2011

Last year, I wrote a blog on “The July Effect”, a long-observed phenomenon of increased hospital deaths during the month of July that was substantiated by medical data and statistics just last year. These data seemed to specifically relate these deaths to the influx of new medical school graduates into teaching hospitals as first-year residents of those institutions. The conclusions of the study seemed well-substantiated. I further elaborated on some of the potential causes of errors being made that could result in harm to patients; what I didn’t elaborate upon was the rigorous and demanding schedule that residents assume.

In 2003, the Accreditation Council for Graduate Medical Education (ACGME) instituted new policies regarding the time limitations of ALL residents, but specifically focused on the first year resident. These limitations were placed on the number of hours that residents could and should work in any given week or rotation in an effort to safeguard the health of the resident but more so to ensure the safety and well-being of patients being treated by these residents.

It is now 2011, and the ACGME is instituting even stricter limitations affecting both first year and mid-level residents; Nixon Peabody does a great job of delineating the changes in the guidelines. Much information has been published in the last year regarding the continued occurrence of medical errors despite protocols and safety mechanisms in place to protect patients (click on related blogs below). It seems that the ACGME is attempting to address some of these errors by addressing the fatigue factor of medical and surgical residents in training. The overall maximum hours per week will not change; it remains at 80 hours.  Yes, twice that of “normal” jobs. One big change is the limit on the maximum continuous duty period for first year residents; this will be decreased from 24 to 16 hours.  It will remain 24 hours for residents after their first year, but recommendations include “strategic napping.” Another change is the additional duty time, previously allotted as 6 extra hours to perform clinic duty, transfer of care, didactic training, etc.; for first year residents, these duties are to be included in the overall 80-hour work week, but after the first year, the residents will be allowed 4 additional hours. A third big change is the minimum time off between duty periods. Previously, it was noted that all residents “should have” 10 hours between shifts; year 1′s are still recommended to have 10  hours off, but they MUST HAVE AT LEAST 8! Intermediate-level residents should also have 10 hours off, but they also must have at least 8 hours off with a mandatory 14 hours off if they just completed a 24-hour shift. Final year residents are recommended to receive 8 hours off, but this is still being reviewed.  One thing that has not changed is the mandatory 1 day off in 7, averaged over 4 weeks.

Many of us watch the medical TV shows, but none of these shows really paint the true picture of medical residency training. As a Physician Assistant student, I trained alongside medical residents and medical students, alike. My training mirrored theirs in the hospital setting, and it happened well before the 2003 ACGME recommendations. There were times during my surgery rotation in a trauma center during which I worked 36 hours straight, followed by 10 hours off, then back to 10- and 12-hour days. The working hours entailed clinic time, managing daily in-patient care, many hours in the operating room, admitting patients during the overnight hours from the emergency room and emergency surgery for trauma victims, hours and hours at a time, in the overnight hours and during the day.  By the end of 36 hours, the exhaustion was indescribable. It is easy to understand how and why mistakes happen. After these crazy shifts, no one ever looked so glamorous as those who are depicted on television shows…..TRUST ME!

July 1, 2011, marks the date when over 100,000 medical residents across the USA from ACGME-accredited training programs start their training in teaching hospitals/institutions across this great nation. We should applaud the ACGME for looking at the data, analyzing studies regarding sleep deprivation, and putting forth these guidelines, not only to aid in patient safety but also to protect the health and well-being of these doctors in training. The pressures of residency are incredible. It is interesting that there was and still is opposition to the duty-hour limitations, citing oppositional rationale such as the residents do not learn enough in 16 hours, and small institutions do not have the support staff to treat all of the patients without the addition of medical resident hours.

So, who is going to fill those gaps created by the resident-hour restrictions placed by the ACGME come July 1st? Each institution will have to look at its own hospital model and decide according to current standards. In 2003, many of these gaps were filled by Physician Assistants and Nurse Practitioners; I suspect this will again be the case.  These mid-level practitioners are quite capable of providing many of the services necessary in hospital settings; they are a growing and well-respected addition to the healthcare team, and I suspect that their usefulness and potential will be more fully appreciated with the institution of healthcare reform!

For more information and Frequently Asked Questions (FAQs) regarding the ACGME guidelines, please go to the website and click on the links!

And, no matter who is caring for you or your loved one, never be afraid to ask questions about therapies and medications being ordered. Be informed!

Related Posts:

“The July Effect”: Where To Seek Medical Care When The Heat Is On

Medical Malpractice – Serious Medical Errors: Failure of the System or Just Plain Ignorance

Study Finds Regional Hospitals Often Are Better At Preventing Medical Errors Than Academic Centers – Kaiser Health News

Tort Reform or Just Plain Medical Care Reform: the debate continues as thousands are injured annually in US hospitals

 

 

 

 

 

 

Week in Review: (May 22 – 28, 2011) The Eye Opener Health, Law and Medicine Blog

Saturday, May 28th, 2011

From the Editor – Brian Nash

Last week’s posts by our blawgers were packed with information about a variety of topics ranging from the medicine you need to know about concussions, living with cancer, cerebral palsy resources and the potential risks of overdosing your child with medications.

On the legal front, we began a series I’m personally excited about. We call it Legal Boot Camp. It will be a series for those in our practice jurisdictions of Maryland and Washington, D.C. Our teacher’s face is on – lesson plans in place. We hope you learn some things about the laws that can affect your lives in the areas of personal injury – particularly medical malpractice law.  Our first class took place with a piece by Sarah Keogh that examines the law in Maryland on the right to claim loss/diminished earning capacity. If you’re wondering if you can have such a claim even if you weren’t working when you were injured, Sarah has some information for you. Check it out. Turn in your class card and have some fun.

We wrapped up the week with a piece by yours truly on a wonderful community outreach program by our local baseball heroes, the Baltimore Orioles. Aptly named – OriolesREACH, this initiative has a number of wonderful events, charities and missions that are worth knowing about. One in particular, Shannon’s Fund, is a great program to help those in need while dealing with the financial burdens while dealing with cancer. It is run by the University of Maryland Medical Center. Read about our challenge to our brethren before the bar in the Greater Baltimore Area.

Without further ado, here are the blogs we posted this past week …. and a sneak peak of the week ahead.

Concussions: The Message of Brian Roberts’ Injury Should Not Go Unheeded

Posted by Brian Nash

Anyone who follows sports is well aware that finally the old school mentality of “gut it out and get back in there” following blows to the head are coming (not too soon) to an end. Committees have been formed, articles written and the national spotlight of the media have finally focused on this issue. Those recommendations, debates and guidelines are beyond the scope of this post. Nevertheless, those involved in sports…Read more >

Children’s Medications: Coming Changes and Tips to Avoid Overdose

Posted by Sarah Keogh

My children are both young; the youngest is now a little past her second birthday. In the last few years, we have had both infant and children medication in the house, liquid and tablets, and I have been very careful to make sure to double-check myself if I ever have to medicate either child to make sure that I am reading the correct dosing matrix for the correct concentration and for the correct child. More often than not, I have found that children need medication when their parents are tired. As parents know – children frequently…Read more >

 

Living With Cancer: What to Expect After the Diagnosis

Posted by Jon Stefanuca

About a million and a half people will be diagnosed with cancer in the U.S. this year. The devastating truth about cancer is that about one-third of these people will die from cancer at some point. For most, the diagnosis is unexpected and completely overwhelming.The cancer does not just affect how one feels, it undermines all sense of security and stability. It changes lifestyles and redefines relationships. So often the emotional trauma is equally shared among family members and loved ones. Read more >

New Blog Series: Legal Boot Camp

Posted by Brian Nash

I’m really pleased to announce a new series we’re starting today. If you’re a reader of our blog, you know that we post numerous times a week on health, safety, medicine and related law topics. That’s what we do in our firm – we represent people who are injured by the negligence of health care providers and those who suffer catastrophic injuries in non-medical settings as well. So, sharing what we believe is some good information about medical, health and safety issues is our mission. We strongly believe that our social networking should be about giving good information, engaging in dialogue about relevant issues – just plain good, old sharing. Read more >

Legal Boot Camp (First Class): The Story of Pam – Maryland’s Law on Loss of Earning Capacity

Posted by Sarah Keogh

A 41-year-old woman, Pam, who was laid off from her job as a swimming instructor and swim coach in December of 2009, has been struggling to find a new position for the last few years. Even though Pam had been working as a swimming instructor full-time for the past 18 years, she felt that she needed to jump into a new career while waiting to find a new position as a swimming instructor and coach. Starting in October of 2010, her father died leaving her a rundown home that he had recently purchased with the intent of renovating it. Pam felt that she could put her physical fitness and knowledge of home aesthetics to work, not to mention the ideas she picked up watching renovations shows while unemployed, by renovating the home her father left… Read more >

Dealing with Cerebral Palsy: A Resource for Parents and Family

Posted by Jason Penn

Today’s society has become increasingly dependent on aggregators. We use a variety of methods to assemble and sort information so that we can easily consume it.  Mint.com and Quicken help with our finances and Google Reader helps to manage our online content. A quick search of the internet suggests that the parents of children withcerebral palsy do not yet have an objective aggregator of information to turn to.  Let’s consider this our attempt to provide parents in the Baltimore and Washington D.C. areas with a place to turn. Read more >

Charity Begins at Home: OriolesREACH Program Hits a Grand Slam with Us!

Posted by Brian Nash

I recently wrote a post about our local area charities and civic organizations who do so much for so many in our community. With that in mind, as I was happily reading the sports page in the warm glow of the Orioles’ 12th inning victory yesterday (5 in a row – Go O’s), I came across a piece about a new initiative for our military personnel by the Birds. While looking at the details of this worthy program, I noticed (ashamedly for the first time, I admit) a host of community programs being run by the Orioles. The team uses the name OriolesREACH for the community programs they sponsor, promote or fund. Read more >

Sneak Peak of the Week Ahead

Here’s a sampling of what’s coming next week on The Eye Opener: Views and Opinions from the Nash Community:

  • As families prepare for the upcoming holidays and summer vacation, Theresa Neumann has some important medical advice about what else needs to be included in your travel plans.
  • Legal Boot Camp: Prepare for our second class – get those pencils, pens, iPads and whatever else you need out and ready – there could be a pop quiz on next week’s primary on law.
  • What rights do babies-before-birth (fetal rights) have in our legal system? Do parents who lose a child just before birth have any rights of recovery? You’ll find out next week.
  • Home births are on the rise. Is that a good or a bad thing? Sarah Keogh weighs in on that issue in the coming edition of The Eye Opener

And….maybe even more to come…you can never tell….

Have a wonderful and safe Memorial Day Weekend. Best to All of You and Your Families and Friends from All of Us at Nash & Associates

Children’s Medications: Coming Changes and Tips to Avoid Overdose

Tuesday, May 24th, 2011

We all know that a little over-the-counter (OTC) pain medication can be just what the doctor ordered for minor aches, pains or to help combat the symptoms of a nasty flu. Most adults, however, also realize that medications can be dangerous. No, I am not talking about the blast from the past news stories about medications that have been tampered with (…though it is weird that the Unabomber, Ted Kaczynski, is back in the news as one possible suspect in the Tylenol poisonings that killed people in the Chicago area in 1982). My focus today is on the danger involved with overdoses of commonly used pain medication. In particular, the risk of accidentally overdosing children on OTC pain relievers such as Tylenol.

Image from www.tylenol.com

There has been quite a bit of focus recently on the possible changes to Tylenol and other acetaminophen containing drugs for children. These are not formula changes and they have nothing to do with the myriad of Tylenol recalls over the past couple of years. Currently, the basic concern is that overdoses of this common medication accounts for a fairly sizeable number of poisoning cases, which can be very serious since overdose can cause liver damage to children. An AP article reports that:

Dosing errors with children’s acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

These overdose situations most often occur in children under 2 years old.

Chart provided on www.tylenol.com

When I read this, I was not surprised. Currently acetaminophen for children, Tylenol and other brands, come in two different concentrations.  Most commonly one is labeled “Children’s” and the other “Infant’s.” Each of these medications include on the outside packaging a confusing little matrix that details the correct dosage for a child of a particular age or weight range. The correct dosing for your child’s age and weight may not be the same if you have a child that is particularly large or small for their age. Additionally, if you have both children’s and infant’s acetaminophen products in your home, you must be careful to provide the correct dosing for the correct concentration. This does not even get into the differences in dosing between the liquid medicine and the tablets. Finally, the box does not provide dosing information for children less than two years of age. The dosing instruction for children under 24 months is “ask your doctor.” So, how many of you are going to make that phone call?

The harsh realities of parenting and sick kids

My children are both young; the youngest is now a little past her second birthday. In the last few years, we have had both infant and children medication in the house, liquid and tablets, and I have been very careful to make sure to double-check myself if I ever have to medicate either child to make sure that I am reading the correct dosing matrix for the correct concentration and for the correct child. More often than not, I have found that children need medication when their parents are tired. As parents know – children frequently get sick in the middle of the night and when children in the house are sick nobody in the household sleeps well. I always try to take this into account to avoid dosing errors. However, this can be confusing particularly when children are little.

When my children were very little, I used to ask the doctor at each appointment what would be the correct Tylenol dose for their current weight. I did not foresee having to use that information, but I wanted to make sure that I knew the correct amount in case I was caught with a sick child in the middle of the night. If it had been a while since my child was weighed, I would sometimes have to call for dosing information. Additionally, I found that it was nearly impossible to dose a child properly using the little cups included with the medication. However, the medicine packaging clearly states that you are only to dose using the enclosed cup. I found that my ability to dose the correct amount of medication was much improved when I used a syringe style dropper.

The FDA steps in – finally!

Well, apparently, I have not been alone in my concerns. The FDA panel that met last week, has made some recommendations that may improve some of these problems in the future and lessen the chances that children will receive too much medication. According to the AP article, the following recommendations have been voted on and will be recommended to the FDA:

  • Dosing instructions should be added for children younger than 2 years old
  • Dosing instructions should be provided based on a child’s weight (rather than the focus being on a child’s age)
  • Limiting cup measurements to milliliters  (rather than both teaspoons and milliliters…one of many things that make the current measurement cups confusing)
  • Mandating a single dosage for children’s solid acetaminophen tablets

Infant Tylenol (and other acetaminophen products) a thing of the past

Relatedly, the article mentioned that the Consumer Healthcare Products Association, which includes the makers of Tylenol and many other acetaminophen producers, agreed to voluntarily stop producing infant drops. This decision means that a day may be coming soon when there would only be one concentration available of children’s acetaminophen.

Some tips and tricks to avoid overdosing your child

If infant acetaminophen is eliminated and children’s acetaminophen is sold with the changed dosing instructions, I think that parents and other caregivers will find it much easier to provide children with the correct amount of medication. However, I would still recommend taking the following steps to protect your children:

  • Keep all medications, including children’s acetaminophen, in a locked closet or other locked secure location away from children.
  • Do not forget to re-secure medication, even when children are sick, so that children are not accidentally able to overdose (when using medicine frequently the temptation to leave it accessible should not overcome the safety element of keeping it away from little hands).
  • Keep a list of the current weight of each child in the house available with the medications so that a caregiver (or tired parent) knows the weight of each child to be able to refer to the dosing chart when needed.
  • Use a clearly marked cup or syringe that is specifically for medicine to dose your child – do not use a household spoon or other imprecise measuring tool.
  • If in doubt on dosing, call the pediatrician to be sure – do not guess!
  • When multiple people will be caring for a sick child (or if you are tired), make sure that you note down the time of each dose of medication to ensure proper timing between doses to avoid accidental overdose.
  • Read the ingredients on any medication carefully to ensure that you do not give your child multiple medications containing the same ingredient – acetaminophen is sometimes added to other medications in combination drugs.

The best advice

Obviously, since I am not a doctor, you should check with your pediatrician if you have any questions about what the correct method is for providing medication to your child, but these tips will hopefully help eliminate some of the more common medication errors in your home.

Your take?

Do you have other tips to share? What about the recommended changes, do you think that additional changes are needed? Do you use fever-reducing medications in your child if your child is not displaying other symptoms, or do you allow the fever to do its work its way out?

The New Enron? Are Hospitals Cooking the Books?

Thursday, April 28th, 2011

Tax season is over. Well, it is over if you filed your return in a timely fashion. Don’t let this blog stop you from stashing away your W-2’s and 1040-G’s for safekeeping. I hope you never need them. But, if you will, indulge me for just a second and leave your calculator out. No, I don’t need you to calculate the ever-increasing cost to fill-up your gas tank. Let’s take a quick look at a few health care statistics. Before you cringe, declare that you ‘hate math!’ and click-back to Facebook, let me share this with you: medical errors occur 10 times more than previously thought. Maybe that wasn’t hard hitting enough. Let me try again. How about this: mistakes occur in one out of every three hospital admissions!

Yes, seriously.

It’s Hard To Measure Without a Yardstick

Despite all of their education and training, medical professionals make mistakes. You know it, I know it, and certainly they know it. I hope that we can also all agree that it is unrealistic to expect for our health care providers to be perfect. What is reasonable, however, is to require an accurate accounting of the mistakes that occur in a health care setting. Believe it or not, there is no uniform method for a hospital to classify, track and otherwise determine what is or is not a medical mistake. A negative outcome at Hospital X in Baltimore might be considered a mistake, and yet if the same negative outcome occurred at Hospital Y in Washington D.C., it would not be considered a mistake. How so?

I don’t want to bog you down with the myriad measures that hospitals use to come up with the numbers but suffice it to say that at any hospital in the United States, its administration could utilize the: Agency for Healthcare Research and Quality’s Patient Safety Indicators or the Utah/Missouri Adverse Event Classification technique, or an approach developed by the Harvard Medical Practice Study, or the Institute of Healthcare Improvement’s Global Trigger Tool, or they can do their own analysis of the records and score themselves (self-reporting.)

That was a mouthful. Essentially, a yardstick for measuring the safety of care in hospitals does not exist. Or, at least, a yardstick has not been agreed upon. The two most common methods used, however, are voluntary reporting and the Agency for Healthcare Research and Quality Patient Safety Indicators. And according to a recent study, those two methods are awful. Before you conclude that I am being too harsh, let’s take a look.

The Good, the Bad, and the Ugly

The study, conducted by David C. Classen, and published in journal Health Affairs, utilized the Institute for Healthcare Improvement’s Global Trigger Tool. The Global Trigger Tool uses specific methods for reviewing medical charts. Patient charts are analyzed methodically, analyzing discharge codes, discharge summaries, medications, lab results, operation records, nursing notes, and physician progress notes to determine whether or not a “trigger” exists. A notation of a trigger leads to further investigation into whether or not an adverse event occurred. Here is how the tools stack up:

Self Reporting (Commonly Used Method #1): 4 adverse events detected

Safety Indicators (Commonly Used Method #2): 35 adverse events detected

Global Trigger Tool: 354 adverse events detected

The Global Trigger Tool is overwhelmingly more sensitive and picked-up many, many more adverse events. Overall, the Global Trigger Tool discovered that adverse events occurred in 33.2 percent of hospital admissions or 91 events per 1,000 patient days. That number is staggering.

What kind of “adverse events” are being missed? Medication errors, surgical errors, procedure related errors, infection, pressure ulcers, device failures and patient falls. All very serious and potentially injurious to a patient. The study indicates that the error detection tool being utilized by Hospital ABC in Yourtown, USA is probably woefully inadequate.

Why Accurate Error Detection Is Important

Error detection is essential to error correction. A hospital cannot identify the areas that need improvement if it is unable to identify the areas where it is falling down on the job. Failure to utilize an adequate error detection tool ensures that the same mistakes will continue to happen time and time again. I think the results certainly beg the question: why not adopt a nationwide standard? The Global Trigger Tool or another sensitive measuring matrix strikes me as a reasonable place to begin.

Certainly, there is a financial aspect to this discussion. Extensive chart reviews and lengthy inquiries into negative outcomes are costly and time intensive. Also, what motivation, besides error prevention, does a hospital have to discover its errors? As I wrote about here before, when errors are discovered, hospitals are penalized. If a hospital’s main concern is its bottom line and not patient safety, why not continue to “self-report” or use the Agency for Healthcare Research and Quality Patient Safety Indicators and leave the adverse events undetected?  Makes sense if you want to avoid the penalties…

It doesn’t say “leave a response” down below for nothing. Feel free to let us know YOUR thoughts.

QUESTION: Have you ever had a negative outcome at a hospital? Where you told that a mistake was made or were you told otherwise?

 

Deadly Super Bugs on the rise.

Wednesday, April 13th, 2011

Health scares are common and are many times overblown. However, the evolution of bacteria that are resistant to antibiotics (dubbed Super Bugs) is a very real and growing danger. Yahoo Health is reporting that two especially dangerous bacteria – MRSA and CRKP – are becoming resistant to all but the most advanced antibiotics, which is posing a major health threat.

Klebsiella is a common type of gram-negative bacteria that are found in our intestines (where the bugs don’t cause disease). MRSA (methacillin-resistant staphylococcus aureus) is a type of bacteria that live on the skin and can burrow deep into the body if someone has cuts or wounds, including those from surgery.

The reason for this new resistance is likely over-use (which includes mis-use) of antibiotics by health care providers (with likely some contribution from use of antibiotics in animals). For a few years now, there has been a growing recognition that doctors are over-prescribing antibiotics, i.e., routinely prescribing antibiotics when they are not necessary. For example, in 2005, U.S. News reported a Harvard study that revealed that doctors routinely prescribed antibiotics for sore throats in children when they were not indicated. A 2007 study indicated that Dutch doctors (whom are generally considered more careful in their use of antibiotics) routinely prescribed antibiotics for respiratory tract infections when they were not indicated.

The Problem with “Overuse”

The danger this poses is that antibiotics – even effective ones – typically leave some bacteria alive. These tend to be the stronger or more resistant bacteria, which then leads to the development of more and more resistance. This occurs in a single individual body in which a patient may have less response to an antibiotic after earlier use of that same antibiotic, but because of the easy spread of bacteria in our world, it also occurs on a global scale. For certain strains of bacteria, doctors are becoming hard-pressed to treat these infections.

CRKP – worse than MRSA?

Thankfully, MRSA is still responsive to several antibiotics so it is still considered a treatable infection. CRKP, however, is of more concern because it is only responsive to Colistin, which can be toxic to the kidneys. Therefore, doctors have no good options when treating CRKP. While so far, the risk of healthy people dying from MRSA and CRKP remains very low, the most vulnerable of us (the elderly and the chronically ill) remain at risk because of their lowered immune system and because the elderly are in nursing homes or other long-term care facilities where infections tend to spread more easily than in the general community.

CRKP has now been reported in 36 US states—and health officials suspect that it may also be triggering infections in the other 14 states where reporting isn’t required. High rates have been found in long-term care facilities in Los Angeles County, where the superbug was previously believed to be rare, according to a study presented earlier this month.

It is essential that we rein in the casual use of antibiotics before we are left with infections that have no cure. Doctors must be better trained to know when antibiotics are necessary and when they are not. For example, antibiotics are useless against viruses (such as the common cold), but how many of you have been given an antibiotic by a doctor “just in case” or because your symptoms have gone on slightly longer than a typical cold would last? It is unfortunately a more common occurrence than we realize. The past success of antibiotics has naturally led doctors to want to give them to patients to relieve suffering. No one wants to turn down a patient who is seeking relief.  However, it makes no sense to give antibiotics to a patient who has no bacterial infection or whose illness will clear up on its own.

Patient Awareness is key

The problem, however, is more than just educating doctors. Patients share some blame too. We – the public – need to learn that antibiotics are not always needed, which can be a difficult lesson to learn when we’re sick. Everyone knows that antibiotics are a quick and effective remedy against common bacterial infections. Antibiotics have saved countless lives over the years and have relieved untold human suffering. So naturally, when we are sick (or our child is sick) and we go to the doctor, we want to see results. We want something that will alleviate the pain and symptoms, not simply be told to wait for the illness to run its course. Sometimes, however, that is the best course when you consider the side-effects of antibiotics and the dangers of over-use. That being said, who wants to hear that when you’re in pain and want relief? It is very easy to demand of doctors that they use all available means to treat a sick child. Doctors need to be able to stand-up to patients and educate them on why antibiotics are not necessarily the best course of treatment in a specific situation.

Don’t kill the good ones!

Doctors also have to teach patients that antibiotics are not targeted killers.  The body contains a lot of good bacteria that are vital to our body’s functioning.  Antibiotics kill those bacteria as well, which some researchers believe can adversely affect health by allowing harmful bacteria to proliferate.  (If you have seen “probiotocs” advertised on certain food products – like yogurt – that is an attempt to introduce good bacteria back into your body.).

Some basic steps to take

In order to protect yourself (or a loved one), good hygiene remains the most effective method of remaining infection-free.  Thankfully, neither MRSA or CRKP are transmitted through the air.  They are typically transmitted through person-to-person contact, or else through hospital equipment such as IV lines, catheters, or ventilators.  If you have a loved one in a hospital or nursing home, be vigilant with your hand-washing and those of the healthcare providers caring for your loved one.

Also, if you are a patient who has been prescribed antibiotics, follow your pharmacist’s orders scrupulously and take the medication in the proper dosage and for the proper amount of time.  Stopping antibiotics too soon can leave bacteria alive, which contributes to the evolution of more resistant bacteria.  You may feel better and want to stop the medication, but it is important to take the full dose.

So – now that you know the risks of over-using antibiotics, are you willing to forego antibiotics when you are sick in order to do your part for the greater good?

UPDATE: (Editor – Brian Nash) Within an hour of posting Mike Sander’s blog on MRSA (and CRKP), I came across a tweet about Manuka Honey is being used for dressings to fight the spread of Super Bugs – particularly MRSA.

Researchers now believe that it can also put a stop to the rates at which superbugs are becoming resistant to antibiotics.

Anyone know of this practice being used in your area hospital or clinics? Does anyone know if this really works? If so, most interesting and useful. Here to spread the word – how about you spreading it too?

Who’s Hawking Rx Drugs? Is It Really an Effective Medication or Just Effective Marketing?

Thursday, October 28th, 2010

We have all seen the non-stop drug ads on TV – a pill or injection that will cure whatever it is that ails us. Public advertising, however, is just one way that pharmaceutical companies get their drugs into the market place. Behind the scenes, there is a full-blown marketing campaign that the public never sees in which drug companies hire doctors (tens of thousands of doctors) to spread the word on their drugs, primarily by giving talks to other doctors.  An ongoing investigation by ProPublica reveals that some of these doctors have significant disciplinary actions in their past:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.  More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

There is no doubt that the pharmaceutical industry (sometimes referred to as Big Pharma) is a huge industry.  According to IMS Health,a healthcare information and consulting company, prescription drugs generate $300 billion in sales in the United States alone.  Therefore, the pressure on drug companies to market their products is immense. For the doctors out there, doing free-lance work for drug companies can be a very lucrative side-business, with some physicians earning as much as $1,500 to $2,000 for giving a single talk to a group of doctors. While there is nothing wrong with marketing a legal product, the public must be assured that the marketing is honest and that the drugs in question are being prescribed because they are effective drugs, not simply because the drug companies have an effective marketing campaign.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

Big Pharma appears to be turning a relatively blind eye to the situation. As part of its investigation, ProPublica compiled a database of physicians who work for the drug companies, and then cross-checked these doctors’ credentials and state disciplinary records.  The drug companies themselves could have taken this approach in vetting their doctors, but most do not bother to do so. Most companies “rely on self-reporting and checks of federal databases.”  However, it is the state disciplinary records that typically contain the relevant data on doctors who have been disciplined (and even state authorities do not always post such infractions on their websites). Lisa Bero, a pharmacy professor at University of California, San Francisco, questions the way that Big Pharma checks on its doctors:

Did they not do background checks on these people?  Why did they pick them? If they did things in their background that are questionable, what about the information they’re giving to me now?

In addition to disciplinary actions, ProPublica also raises questions as to these doctors’ credentials, e.g. medical research, academic appointments and professional society involvement, that would make them especially qualified to speak on medical conditions and ways to treat them. The investigation highlights a Las Vegas endocrinologist who has earned over $300,000 from Big Pharma. However, ProPublica contends that it was unable to locate any credentials on this doctor other than his schooling and some 20-year-old research articles. Furthermore, an online brochure from a recent presentation given by this doctor indicated that he was the chief of endocrinology at a local hospital, but “an official there said he hasn’t held that title since 2008.” Such stories only add to the serious questions as to how Big Pharma is selecting its doctors.

Certainly, a lot of good can come from honest marketing of effective new drugs. Especially in out-of-the way places, a talk by a knowledgeable physician can be a great source of information on new treatments available for a certain disease. If a new drug is truly effective, then by all means the word needs to get out on that drug because such drugs allow us to live longer and to live more comfortably with what were once debilitating diseases.  However, the public must demand honest assessment of these drugs. When drug companies allow unscrupulous doctors to hawk their wares, it raises legitimate suspicion as to whether these drugs are so popular because they are truly effective or simply because they had a good marketing blitz.

If you are curious about a specific doctor, ProPublica has a searchable database of doctors who do work for drug companies. Also, ProPublica has published several follow-up and/or related articles which can be found here.

Medical Malpractice – Serious Medical Errors: Failure of the System or Just Plain Ignorance

Wednesday, October 27th, 2010

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Tort Reform or Just Plain Medical Care Reform: the debate continues as thousands are injured annually in US hospitals

Monday, October 25th, 2010

HEADLINES AND EXCERPTS

Wall Street Journal, September 28, 2010, diagnostic errors kill 40,000 to 80,000 patients annually based on autopsy studies over past 4 decades.

American Medical News, August 23, 2010, an estimated 1.5 million medical errors cost the US economy $19.5 billion in 2008.  

CNBC.com, October 19, 2010, the Colorado Physician Insurance Company found between 2002 and 2008, 25 surgeries were performed on the wrong patient, and another 107 surgeries were performed on the wrong body part. One-fourth, approximately 6 patients suffered significant injury. There was 1 death.

News from the National Academies, October 21, 2006, medication errors injure 1.5 million people annually. 400,000 injuries occur in hospitals; 800,000 occur in longterm care; and 530,000 occur in Medicare outpatient clinics. Estimates were conservative.  Treatment of hospital injuries cost more then $43.5 billion annually. Lost wages, productivity, or additional healthcare costs were not included.

HealthGrades, April 2008, published 3 years of Medicare data from 2004-2006 in their 5th Annual Patient Safety in Hospitals Study. They found 1.12 million patient safety incidents occurred representing a 3% incident rate; and 270,491 in hospital deaths were directly attributable to an incident. The incident rate was unchanged from the 4 previous annual reports.  The incidents accounted for $8.8 billion in excess cost.

HealthGrades, April 2009, also reported improved data in the 6th Annual Patient Safety in Hospitals Study.  Inpatient Medicare admissions from 2005 to 2007 were studied. Only 913,215 patient safety incidents occurred with an associated $6.9 billion in excess costs. Instead of a 1 in 5 chance of dying from a safety incident in 2004-2008; patients’ odds improved to 1 in 10 chance of dying from an incident by 2007.

Institute of Medicine of the National Academy of Sciences, 2000, estimated medical errors kill up to 98,000 US hospital patients each year.

_______________________________

I decided to write about patient injuries in American hospitals 2010 because – frankly – my career in healthcare quality assurance and risk management was launched as a direct result of a landmark study released in 1978.  Don Harper Mills, M.D. published a study known as the California Medical Insurance Feasibility Study (CMIFS). In 1978, no one knew how many people were actually being injured in hospitals. There was a crisis of available liability insurance for physicians and hospitals, and as a result, compensation alternatives were being considered. In order to fund compensation alternatives for patient victims, actual injury data was needed.

Dr. Mills and his colleagues manually reviewed 20,864 hospital patient medical records from 23 representative California hospitals for the year 1974. They found 970 patients were directly injured by a medical mistake. This was 4.5% of the entire records sampling.  What shook the healthcare industry to the core in 1978 was the following:

When expanding the study sample size to the full statewide population, the data showed there were:

  • 6.5% minor permanent injuries – 9,100 patients;
  • 3.8%  major permanent injuries – 5,300 patients; and
  • 9.7% suffered death – 13,600 patients.

If all of these patients were to be fully compensated under full disclosure and/or no fault insurance plans, the state would not have been able to fund the approach. Insurance companies and states across the country began looking at closed medical malpractice claims, statewide data, medical records that showed the same trends were a national and not just a “California” problem.

Throughout the early 1980’s, we saw state and federal regulations mandating hospitals implement physician peer review and quality assurance programs. Medical malpractice insurance companies and brokers sent consultants into hospitals to begin teaching staff how to set up systems for monitoring care and correcting/improving systems.

The American Society of Healthcare Risk Management was born creating national and state-based initiatives to reduce injuries. The American College of Surgeons published their first Patient Safety Manual for medical staff leadership.

Initiatives from the Joint Commission for the Accreditation of Healthcare Organizations continued into the 1980’s and 1990’s with expanded quality improvement standards.

This great computer age has allowed more sophisticated and widespread comparison of insurance, state and national data than ever before. The data tragically continues to reveal dismal results despite decades of government, state, regulatory, and social pressures for hospitals, physicians, and healthcare professionals to improve.

THE DEBATE RAGES ON …WHAT WILL FIX IT?

While the AMA continues to whine about being sued too often and the tragic impact on physicians, as you see the data show that for decades, patients continued to be significantly injured. A study by Harvard researchers, who reviewed 1452 medical malpractice closed claims in 2006, reported 75% had legal awards consistent with their merit. Two reports by Dartmouth economists in 2005 and RAND in 2004 found awards were consistent with the rising costs of medical care and average awards grew less than real income. The more costly medical care was responsible for more then half the jury awards. A study of American insurance data between 2001 and 2004 showed malpractice awards per doctor were stable or fell, and premium increases were not connected to awards.

In 2009, the Canadian Medical Association Journal reported there was no evidence US doctors were experiencing increasing numbers of lawsuits during 2001-2004.  Over 15 years, states had reported physician insurance premium rates were flat or declined relative to economic and population changes.  The article cited opinions that the problem was not litigation; the problem was malpractice.  However, the AMA is persistent in claiming financial relief is needed. One means they propose is to limit of non-economic damages for pain and suffering nationally to $250,000.

Very recently, American Medical News (amednew.com) issued a summary of 20 new grants issued by the Dept. of Health and Human Services at a cost of $25 million. The grants are to find ways to cut medical errors and improve communication between doctors and patients.  Highlights were:

  • New patient safety programs that include data designed to link with medical liability claims.
  • New York won $3 million to expand and test a judge-directed negotiation program for surgery and obstetrical injured patients.
  • The University of Washington in Seattle won $2.97 million to train physicians, nurses, and pharmacists to communicate.
  • Ohio State University of College of Medicine won $186,214 to establish a statewide database on pregnancy-related deaths for study towards improving outcomes.
  • South Dakota and Sanford Health won $299,995 to develop a state model for collecting medical error data and to design a patient complaint reporting system.

Ironically, the Wall Street Journal article (September 28, 2010) reported physicians were learning from reviewing closed lawsuit claims data. As a result, “Some doctors are using electronic alerts and reminders to order tests, follow-up lab data, and communicate with referral specialists.”

WHY AREN’T THEY ALL DOING THIS?

This June’s Archives of Internal Medicine reported 91% of doctors practice defensive medicine and order too many tests adding huge unnecessary costs to the healthcare system.  The Wall Street Journal article reported a better solution is to  improve larger system failures and prevent errors. Kaiser Permanente uses medical malpractice data for education, but also focuses resources on technology to reduce patient injuries, i.e. close tracking and follow-up of patients with abnormal testing results. The VA is doing the same through an electronic medical record system. This is encouraging.

The insurance company representing Harvard University affiliated hospitals and doctors uses lawsuit data to focus on improvement strategies. Again, from my perspective having worked in the past for a large insurance broker, a statewide project funded by an insurance company, and a medical malpractice insurance company, this is NOTHING NEW.  Out of 456 high severity cases resulting in serious harm to patients, most were diagnostic errors. The insurance executive for the Harvard account is hoping to spur changes in systems and procedures and reduce this finding.

I am hoping he will see results. I trust the headlines will continue to print those results and trends for us to follow.

We can only hope that the coming years will see a dramatic reduction in these preventable medical injuries.

Drug information found lacking

Thursday, August 19th, 2010

Millions of people take daily or weekly medications for a variety of health concerns.  As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc.  The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.

Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications:  lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet).  The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability.  The reason for these variances?  Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not.  The FDA only provides recommendations for leaflets.  Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.

The differences found by Dr. Kimberlin were striking.  Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet.  Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria.  Only one leaflet for metformin met this same criteria.  The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.

While the differences in content were significant, the study found that even greater differences existed in readability.  It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons.  All of this can make deciphering these leaflets even more difficult.

In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.”  For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.

The bottom line – carefully read the product leaflet that comes with your prescription.  And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly.  You may not be able to rely on the information contained in the product leaflet.


Just how ‘safe’ are these new computerized prescription entry programs being used in our hospitals?

Wednesday, July 7th, 2010

Some years ago, an new medical acronym was added to our lexicon – Computerized Physician Order Entry (CPOE). As you might suspect, CPOE has as its primary goal the improvement in patient health care safety. One entity spawned as a result of CPOE bears its own acronym, POET, Physician Order Entry Team, which is a research team at Oregon Health & Science University, funded by a grant from the National Library of Medicine to study the success and “unintended consequences” (read errors) of CPOE. The University has a website dedicated to CPOE bearing the domain www.cpoe.org. The purpose of CPOE, according to this website, is as follows:

Computerized physician/provider order entry is defined as the computer system that allows direct entry of medical orders by the person with the licensure and privileges to do so. Directly entering orders into a computer has the benefit of reducing errors by minimizing the ambiguity of hand-written orders, but a much greater benefit is seen with the combination of CPOE and clinical decision support tools.

If you have ever had to read the hand-written entries of a medical record (which we do daily), you can appreciate the concept behind CPOE. But what are these “clinical decision support (CDS) tools”? Which institutions have this CPOE with CDS? How is this new technology doing in terms of improving patient safety?

Clinical Decision Support (CDS) tools:

One source cited by CPOE.ORG identifies these “tools” as follows:

We defined clinical decision support broadly as “clinical information” that is either provided to you or accessible by you, from the clinical workstation (e.g., enhanced flow sheet displays, health maintenance reminders, alternative medication suggestions, order sets, alerts, and access to any internet-based information resources).

Who is using CPOE?

Addressing the next question – which institutions are using CPOE – we are told -

When CPOE is coupled with clinical decision support (CDS), research at leading academic medical centers has shown that medical errors may decrease and costs often drop. However, CPOE with CDS is not available in the vast majority of community hospitals, which account for approximately 96% of all U.S. hospitals. The gap in health information technology implementation between community hospitals and teaching hospitals may have serious consequences for patient safety and rising health care costs. (Emphasis added)

Alright – so the majority of hospitals in this country are not even using CPOE. How are academic hospitals doing then with this computerized system of entry and “clinical decision support” tools?

Apparently quite a few people need either some improved programming skills or end-user computer training.

CPOE Medication Errors:

A recent blurb in amednews reports -

The National Patient Safety Foundation has awarded a grant to the Center for Patient Safety Research and Practice at the Brigham and Women’s Hospital and Harvard Medical School in Boston. The grant funds activity to study errors associated with computerized prescription order entry systems.

Researchers will look at approximately 200,000 records of errors for which CPOE was listed as a contributing factor. (Emphasis added) The study is set to focus on the nature of the errors and how better-designed systems could have prevented them. Researchers said they also will develop a new classification for CPOE-related errors so that more useful data can be collected.

The research comes at a time when many hospitals and health care systems are in the process of adopting CPOE systems to qualify for meaningful use incentives made available under the 2009 stimulus package.

So while CPOE may have made my job as a malpractice lawyer easier – or at least easier on my weary eyes from reading illegible hand-written entries in medical records, it appears that this “safety system” has a long ways to go. How do hundreds of thousands of prescription errors occur in CPOE? Hopefully, the grant money being used to ferret out the causes (root cause analysis) of these errors will be well spent and the systems fixed before they are adopted by the majority of our country’s hospitals.

Then  - on the other hand – notwithstanding the risk of sounding like a luddite, perhaps Aldous Huxley got it right.

“Technological progress has merely provided us with more efficient means for going backwards.”