Archive for the ‘Medical Research’ Category

Week in Review: If you missed this past week’s blogs – catch up!

Sunday, April 10th, 2011

This past week was a busy one for our bloggers. It was also a very busy week in our law practice. Over the last two months, we have also had two new lawyers join us – Sarah Keogh and Jason Penn. Sarah has contributed a number of posts already. Jason , who just started this past Monday, will soon be sharing his contributions, thoughts and comments with you as well. We’re very happy to have both of them. I’m sure you join us in wishing them a very warm welcome.

Last week our writers covered a number of topics related to health, medicine, child safety, medical technology and patient safety. We started the week off with a piece by Brian Nash on some key facts women need to be aware of when having an epidural for labor, delivery and post-partum pain relief.

Epidurals

There can be no doubt that thousands of epidurals are administered to women every day throughout this country. This form of analgesia (pain relief) has become probably the most popular form of anesthetic management and apparently is generally believed to be essentially risk free. As this week’s piece, Having an epidural when you have your baby? 3 questions to ask the doctor, reports, some literature gives the figure of complications from epidurals as high as 23% - ranging in severity from minor inconveniences, to life-long major disabilities and even death.

This particular piece was written as a result of several cases in which we have been involved when women, who had undergone an epidural, became essentially paralyzed from the waist down. We raise some questions for women to ask the doctor and suggest they just might want to ask those questions before they find themselves in the process of labor or when they are going through the recovery phase of having given birth to their baby. We believe it’s an important piece for women – and frankly for all – to read so that they have a much better idea of what they should expect with an epidural and what the risks and benefits are of this wonderful yet potentially life-altering anesthetic technique.

Shaken-Baby-Syndrome

On Wednesday, Jon Stefanuca again brought to the public’s attention a problem that is probably as old as childbirth. Everyone who has had the experience of taking care of a child – particularly a baby – knows that along with the joy of parenting comes the physical and emotional toll on parents and care-givers. The human condition makes us all susceptible to being less than completely tolerant, forgiving and gentle with little ones when we are under stress, frustrated or just plain exhausted. The response to the persistent crying can simply not be “a good shake.”

Medicine and science (and unfortunately the courtroom) have given a name to a syndrome of injury babies can suffer when that “just a good shake” approach is used. While a parent or care-giver may think it unimaginable to strike a child, they may not realize just now much harm they can do with “just a good shake.” Jon brings this information and some expert tips and tricks on how to deal with these difficult times parents and care-givers face in their everyday lives in his piece Shaken Baby Syndrome – What we all should know to prevent child abuse.

Makena: New Anti-Prematurity Drug

Thursday, Sarah Keogh reported on a relatively new drug called Makena, which has been found to help pregnant women, who have previously had a premature infant. I say “relatively” since according to Sarah’s piece, a compounding pharmacy could and was making this medication prior to the FDA giving K-V Pharmaceutical Company the exclusive rights to manufacture this drug for a period of 7 years.

Read Sarah’s piece, Makena: Drug to fight prematurity leads to major firestorm, and see what the controversy is all about. How could people possible be upset with a drug that can fight premature birth? Prematurity is one of the major causes of significant childbirth injuries such as cerebral palsy. Sarah’s blog makes it all too clear why people are upset and why the March of Dimes withdrew its sponsorship for Makena.

Medical Technology and Patient Safety

The week ended with Part II of my series on medical technology and whether all the new toys, bells and whistles of our modern healthcare system are truly advancing safe, efficient and effective delivery of healthcare. The week’s piece focuses on perhaps one of the largest advances in the healthcare industry – electronic medical records (EMR).

The blog, Medical Technology and Patient Safety – Part II – EMR’s (electronic medical records), brings a lawyer’s perspective to this topic. Much has already been written – and frankly will continue to be written – about EMR’s by the medical profession. Controversy has filed the pages of journals and at times probably slowed traffic on the internet (okay – maybe that’s a bit of an exaggeration) since this new marvelous technological advance was rolled-out in our medical institutions.  Those writing and fighting about it have been the end-users themselves – the medical professionals, who have to deal with the issues and flaws that have surfaced with this wonderful new technology. I thought it was about time to tell you how this plays out by another end-user – the lawyer who now deals with EMR’s. This piece is also intended as the foundation for what we as lawyer have seen play-out in terms of patient safety and health as a result of EMR implementation.

Sneak Peak of the Week Ahead

I anticipate that next week we’ll be seeing Jason Penn with his first blog on a recent report about numerous safety violations by hospitals in our practice jurisdictions – Maryland and Washington, D.C. Mike Sanders will be bringing to our readers aN old but back-in-the-news report on super infections, which still seem to be – unfortunately – thriving in our nation’s hospitals. We’ll start off this coming week with a piece by Theresa Neumann, our highly acclaimed in-house physician’s assistant expert, on spinal stroke. We all know about strokes that can damage the brain. Theresa will be sharing her insights on an equally devastating stroke of the spinal cord. I also suspect – shhh – that we’ll be reading more from Sarah Keogh this coming week. If the practice of law doesn’t get too much in the way, I am also hoping to share with you some real life examples – from a lawyer’s perspective – of just how EMR’s may not be advancing the causes of patient safety and health.

As with all our blogs, we sincerely invite you to not only read our thoughts and comments but to also share yours with us and our readers. Our latest stats show that around 10,000 pages are viewed by our readers and visitors every month! We sincerely thank all of you, who have taken the time out of your busy lives to read our offerings in The Eye Opener – Views and Opinions from the Nash Community. We invite you to share our posts with your friends and colleagues. Don’t forget to sign-up for easy delivery to your email inbox. Last – but certainly not least – come join our social media communities on Facebook and Twitter.

Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Blog Series – Part I

Monday, March 28th, 2011

Medical Technology - source: Siemens.com

This is the first installment of a series of posts on issues relating to new advances in medical technology and how they may affect patient health and safety – not always for the good. Unless you live in a cave or just don’t care, you must have noticed news reports about how the medical industry is awash in the creation and implementation of new technologies. Presumably these new medical tech toys and gadgets are intended to advance the timely, enhanced, cost-effective delivery of healthcare with the end point being improved patient care and patient safety. The question is – do they always do that or can they, in fact, be tools the lead to patient injuries and – at times -even death?

I recently came across a posting by Dr. William L. Roper, MPH, CEO of the University of North Carolina Health Care System, which was in essence a transcript of a speech he gave at the Agency for Healthcare Research and Quality (AHRQ) in Washington, D.C. on March 23, 2011. Among his other vast accomplishments, in the spring of 1986, he was nominated by President Reagan and confirmed by the Senate for the position of administrator of the federal Health Care Financing Administration, with responsibility for the Medicare and Medicaid programs nationally. For the previous three years, he served on the White House domestic policy staff.

I bring Dr. Roper’s recent remarks to your attention since they are the inspiration for this series of blogs. While Dr. Roper’s address did not specifically address topics such as EMR’s, COW’s (still wondering how a cow fits into this topic? Stay tuned!), and the like, the following selected excerpts are the seeds of thought for the present series:

I have the job of leading an academic medical enterprise, and am challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.

The Institute of Medicine, under Sam Their’s and then Ken Shine’s leadership, played a very important role across the decade of the 1990s, defining “quality” in health care, and pointing to problems in quality and patient safety. Bill Richardson led a multi-year IOM initiative that included the groundbreaking report, To Err is Human in 2000, and then Crossing the Quality Chasm in 2001.

These reports were a clarion call for action – especially making the point that a systems approach was required to deal effectively with these issues.

While Dr. Roper’s speech was, in large part, an historical analysis of progress in the Medicare healthcare delivery system, it is also a well-versed commentary on the so-called advances in medicine for patient care and safety. Why else have so many toiled for so long in trying to find system-failures and methodologies for eradicating those failures and thereby improving the delivery of safe, efficient and effective healthcare?

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level . . . [W]e are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

What has technology done to improve healthcare?

The answer, in short, is – some amazing things and some not so amazing things have taken place in terms of technological advances in healthcare. Unfortunately, as we will explore in this series, some of these technological advances have led to some catastrophic results for patients. One need look no further than how the medical institutions rushed to implement the newest, shiniest and “best” radiology machines and through their haste left in their wake scores of maimed and dead patients. We reported on this investigation by NY Times reporter, Walt Bogdanich  in Eye Opener, over a year ago.

Just over the course of the last year or so, our firm has been involved in case after case in which this issue of medical technology and patient care/safety keeps rearing its ugly and devastating head. We will share with you (leaving identifying information obscured as we are required to do) tales of just how medical technology can impact – positively and (unfortunately) negatively patient health and safety. We’ll analyze and discuss our views on just how well medical technology and its implementation (more the latter) have, in our view, negatively impacted – all too often – patient health and safety. We invite you to follow along as we consider the good, the bad and the ugly of medical technology such as EMR’s, COW’s, iPads and the like. Please join us and share your comments along the way.

Some related posts to get you started:

The Radiation Boom – Radiation Offers New Cures and Ways to Do Harm

FDA Unveils Initiative To Reduce Unnecessary Radiation Exposure from Medical Imaging

At Hearing on Radiation, Calls for Better Oversight

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The Story of How a New York Times Reporter – Walt Bogdanich – Has Made a Real Difference in Medical Device Radiation Safety

The Week in Review: did you miss last week’s posts on health, safety, medicine, law and healthcare? A sneak preview of the week ahead.

Saturday, March 26th, 2011

Eye Opener - Nash & Associates Blog

This week we are starting a weekly posting of our blogs of this past week, some key blogs of interest to our more than 6,500 monthly readers, and a sneak preview of what’s coming next week. We would really like for you to join our community of readers, so don’t forget to hit the RSS Feedburner button or subscribe to our blog, Eye Opener. We share with you our thoughts, insights and analysis of what’s new in the law, the world of law and medicine, health, patient and consumer safety as well as a host of other topics that we deal with as lawyers on a daily basis in trying to serve the needs of our clients.

For those of you on Twitter, Facebook and LinkedIn, we have a vibrant presence on those social networks as well. Hit the icon(s) of your choice and become part of our ever-growing social network community. Share your thoughts, share our posts, give us your feedback on what YOU would like to hear about.

This Past Week

Birth Defect Updates: Warnings About Opioid Use Before and During Pregnancy In this post, Sarah Keogh, explored a new report which is vital information for women who are pregnant or thinking about becoming pregnant. Opiods, narcotic pain killers such as morphine, codeine, hydrocodone and oxycodone, are a valuable part of a physician’s drug armamentarium, but they can have significant implications for a fetus if taken during pregnancy or even just before a woman become pregnant. Read Sarah’s important piece, be informed and learn why you should discuss the use of any such drugs with your obstetrician/gynecologist before taking them.

 

Doctors Disciplined by Their Own Hospitals Escape Actions by Licensing Boards. Who’s at Fault? Brian Nash, founder of the firm, writes about a serious problem with this country’s medical licensing boards, who have failed, at an alarming rate, to take disciplinary action against physicians, who have had their hospital privileges revoked, suspended or curtailed for issues such as sub-standard care, moral transgressions and the like. Public Citizen brought this story to light; we analyze the issue and share our thoughts on this serious patient health and safety issue.

Decreasing Obesity Risks in Children: Another Benefit of Breastfeeding A mom herself and an advocate for public health childhood obesityand safety throughout her legal career, Sarah Keogh reports on a recent study covered by the Baltimore Sun about the long-term benefits of breastfeeding for at least six months. The issue for many, however, is – how can a family of two income earners afford to do this? Does our society and the workplace really lend itself to this practice? Read Sarah’s compelling piece and share your experience and thoughts.

The Week Ahead

Sneak preview of what’s ahead during the week of March 28, 2011:

medical technology

Brian Nash begins a series on the issue of medical technology and patient health/safety. Is the medical community being properly trained in the proper and safe use of all the new medical devices that are hitting our hospitals, clinics and medical offices? Is the rush to have the newest, shiniest and “best” new medical device really advancing the safe and effective delivery of healthcare in our country? Here’s a sneak preview…

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a much better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

Some top posts you may have missed

What happens when your surgeon has been up all night and you are being wheeled into the operating room to be his or her next surgical case? We looked at an article from The New England Journal of Medicine that addressed this patient safety issue and made recommendations for change.  See our posting entitled A Surgeon’s Sleep Deprivation and Elective Surgery-Not a good (or safe) combination.

Dr. Kevin Pho, who is the well known editor and contributor of KevinMD.com, wrote a piece in which he espoused his belief that medical malpractice cases really do not improve patient safety. Having read this piece and finding that this was just too much to digest, Brian Nash wrote a counter-piece entitled Malpractice System Doesn’t Improve Patient Safety – Oh Really? What this led to was cross-posting by Dr. Kevin Pho on our blog, Eye Opener, and our posting on his blog. Our blog post (as best I can tell) led to one of the all-time highest postings of comments by readers of KevinMD. One thing all participants in the “debate” learned – we are both passionate about our positions. Read what led to this firestorm.

 

Birth Defect Updates: Warnings about opioid use before and during pregnancy

Monday, March 21st, 2011

Photo credit: Getty Images

Recently, I wrote about studies concerning the increased risk of birth defects caused by smoking.  A recent press release from the CDC draws attention to a newly discovered link between the use of certainly prescription opioid pain relievers by a woman shortly before conception or in the first trimester of pregnancy to an increase in birth defects.  Similar to the evidence about smoke exposure, the research identifies the period before conception and during early pregnancy as critical.  I think that these findings raise questions about the use of these drugs by woman of child-bearing age as the critical time period may be one when a woman is not aware that she is pregnant or going to become pregnant.

Use of these opioid pain relievers, such as codeine and oxycodone, “was linked to several types of congenital heart defects as well as spina bifida, hydrocephaly, congenital glaucoma and gastroschisis.”  According to the press release, the study, which was published in the American Journal of Obstetrics and Gynecology, “found that women who took prescription opioid medications just before or during early pregnancy had about two times the risk for having a baby with hypoplastic left heart syndrome (one of the most critical heart defects) as women who were not treated with these opioid medications.”   Overall the CDC statement suggests that the risk of these defects is not that large for any individual woman given the rarity of these conditions, but that it is important information nonetheless since the defects are very significant.

Cerebral Palsy rates dropping in U.S.

In happier news, overall rates of cerebral palsy are dropping in the United States.  The cause of the decline is linked to improved care during pregnancy and at birth.  According to Medical News Today, a new “…article published in The Journal of Pediatrics indicates that the rates of cerebral palsy have declined dramatically in the past 15 years.” This is exciting news not just because it means that many fewer children are born with a devastating injury but also because it is an indicator of a general improvement in the care provided to mothers and babies before, during and immediately following birth.

 

 

Smoking and Secondhand Smoke Increase Risk for Birth Defects and Stillbirth – Even before pregancy

Thursday, March 17th, 2011

Photo courtesy of Impact Lab

Recently, I came across several news articles regarding risks that can lead to birth defects.  While it has long been known that smoking during pregnancy is not healthy for the mom or her developing baby, a new study is showing that a mom who smokes during pregnancy creates a huge risk of heart defects in her baby.  A Reuters article explains that the potential for harm caused by smoking during the first trimester of pregnancy, a time when many women may not even realize they are pregnant, is significant:

Specifically, women who smoked early in pregnancy were 30 percent more likely to give birth to babies with obstructions in the flow of blood from the heart to the lungs, and nearly 40 percent more likely to have babies with openings in the upper chambers of their hearts.

While smoking later in pregnancy can also cause birth defects, it is the critical period in early pregnancy when organ development occurs that causes the risk to be so significant at that time.

The Reuters article goes on to explain that the new study, in the journal Pediatrics, does not explain precisely why smoking so dramatically increases the risk of heart defects. However, given the risk, women not smoking before or during early pregnancy could decrease the number of children born with these defects.

A news release from the CDC adds that this study and other research suggest that if women quit smoking before or very early in pregnancy, they could avoid as many as 100 cases of the obstruction type of heart defect and 700 cases of abnormal openings in the upper heart chambers each year in the United States.

This is yet another great reason for woman to quit smoking as soon as possible and certainly before trying to get pregnant.

Secondhand Smoke Risks to Your Baby

We cannot let spouses, partners or other people in the mothers’ lives off the hook when it comes to smoking cessation.  A blog article on The Chart from CNN discusses a new study, also from the journal Pediatrics, which gives a convincing argument why woman must avoid secondhand smoke during and even before pregnancy.  The “[r]esearchers found exposure to secondhand smoke increased a non-smoking pregnant woman’s [chances] of having a stillborn by 23 percent, and increased the risk of delivering a baby with birth defects by 13 percent.”  The article went on to explain that the risk of having a stillborn or delivering a baby with birth defects is almost as large for a woman who does not smoke but is exposed to secondhand smoke as for a woman who smoked herself.  The risks of having a stillborn are increased 20-34% when the mother herself is the smoker and the risks of birth defects are increased by 10-34%.

Aren’t these compelling reasons to continue to work hard as a society on prevention and smoking cessation for the young?  It is too late to wait until child-bearing age when women may already be causing unnecessary harm to their unborn children before they know they are pregnant or by sharing their lives with individuals, who are not able to quit smoking fast enough to prevent harm before conception or during early pregnancy.

New Treatment Holds Promise for Patients With Spinal Cord Injuries

Wednesday, February 23rd, 2011

According to a recent article in Medical News Today, Functional Electrical Stimulation (FES) can significantly reduce disability caused by spinal cord injuries. The study was originally posted on line in the Journal of Neurorehabilitation and Neural Repair.

This relatively new treatment applies small electrical impulses to stimulate paralyzed muscles. The treatment has been shown to measurably improve a patient’s ability to pick up and hold objects. Dr. Popovic and his team concluded that FES should be used in conjunction with traditional physical therapy.

To see how this works, here’s an incredible demonstration by Children’s Hospital of an FES bicycle.

httpv://www.youtube.com/watch?v=27vIfWdB3wk

Here are some key facts about this study:

  • FES therapy uses low-intensity electrical pulses generated by a pocket-sized electric stimulator.
  • Unlike permanent FES systems, the one designed by Dr. Popovic and colleagues is for short-term treatment. The therapist uses the stimulator to make muscles move in a patient’s limb. The idea is that after many repetitions, the nervous system can ‘relearn’ the motion and eventually activate the muscles on its own, without the device.
  • The randomized trial, believed to be the first of its kind, involved 21 rehabilitation inpatients who could not grasp objects or perform many activities of daily living. All received conventional occupational therapy five days per week for eight weeks. However, one group (9 people) also received an hour of stimulation therapy daily, while another group (12 people) had an additional hour of conventional occupational therapy only.
  • Patients who received only occupational therapy saw a “gentle improvement” in their grasping ability, but the level of improvement achieved with stimulation therapy was at least three times greater using the Spinal Cord Independence Measure, which evaluates degree of disability in patients with spinal cord injury.
  • Based on their findings, the study’s authors recommend that stimulation therapy should be part of the therapeutic process for people with incomplete spinal cord injuries whose hand function is impaired.
  • Dr. Popovic’s team has almost completed a prototype of their stimulator, but need financial support to take it forward. Dr. Popovic thinks the device could be available to hospitals within a year of being funded.One limitation of the study is that the research team could not get all participants to take part in a six-month follow-up assessment. However, six individuals who received FES therapy were assessed six months after the study. All had better hand function after six months than on the day they were discharged from the study.
  • Dr. Popovic stresses that FES therapy should augment, and not replace, existing occupational therapy.
  • Another study, now underway, will determine whether stimulation therapy can improve grasping ability in people with chronic (long-term) incomplete spinal cord injuries.

If you or a loved one suffer from spinal cord injury, please consult with a physician about FES. In conjunction with physical therapy, this non-invasive medical procedure promises tremendous benefits to patients with spinal cord injuries. If you are aware of other studies or treatment relating to rehabilitation from spinal cord injuries, we encourage you to share your knowledge with our readers.

New Microchip Promises to Make Life Much Easier for Paraplegic Patients

Friday, February 11th, 2011

Hope for those with paraplegia?

Researchers in the U.K. have developed a revolutionary microchip muscle stimulator that will enable patients with paraplegia to exercise multiple muscles at the same time. According to the Engineering and Physical Sciences Research Council (EPSRC), the microchip developed by Professor Andreas Demosthenous from University College of London and his team is truly unique.

The microchip chip is small enough (approximately the size of a child’s fingernail) that it can be implanted directly into the spinal canal. Unlike previous models, the new implant incorporates the muscle stimulator and the electrodes into a singular unit.  The unit is properly sealed to protect against moisture, which could lead to corrosion of the electrodes.

The creation of the implant has been made possible by new laser processing technology, which enabled researchers to micro-pack all components into one unit. With this new laser technology, researchers were able to cut much tinier electrodes from platinum. The electrodes are then folded into a 3D shape that resembles pages in a book. Each electrode can be wrapped around a nerve root. The electrode is then welded to the microchip located in the spinal cavity.

Because the implant comes with multiple electrodes, which can be connected to multiple nerve roots, it is capable of controlling entire muscle groups. In patients with paraplegia, the devise can be used to stimulate or trigger multiple paralyzed muscles at the same time. Researchers also claim that the new device will also be used in patients with bladder or bowel incontinence.  Because the device has multiple electrodes, some electrodes can be connected to nerve roots that control bladder muscles or nerves that control bowel capacity.

Although all of this may sound a bit scifi, the implant will be available for pilot studies sometime this year. If you or someone you know is paraplegic, this research is worth following. It clearly promises to offer life-chaining benefits to patients with paraplegia. If you know of other research on similar devices, we’d love for you to share that information with our readers. We’ll try to keep an eye on the progress and implementation of this device from the UK and keep you posted if and when developments occur.

A Surgeon’s Sleep Deprivation and Elective Surgery – Not a good (or safe) combination

Friday, January 14th, 2011

The New England Journal of Medicine published a Perspective on December 30, 2010, that screams common sense and should be embraced as a starting point to implement some new patient-safety standards of practice.

Place yourself in the position of a patient getting ready to undergo an elective (i.e. non-emergency) surgical procedure. You’re wheeled into the operating room for your surgery and are greeted by your surgeon in the process. Your mind is focused on just coming out alive and better than when you went in. What you don’t know, however, is your surgeon has been up all night handling a busy call schedule. If you knew he/she was dead tired as any human being would be under the circumstances, would you really want this surgeon operating on you? If you don’t care, then this post is really of no interest to you. If you do care, then read on.

Well, you’re still reading…so you must have some level of concern for your safety. Good for you because here’s a startling number in terms of adverse incidents when involving sleep deprived surgeons:

Researchers have documented the adverse effects of sleep deprivation and sleep disorders on individual performance. In surgery, there is an 83% increase in the risk of complications (e.g., massive hemorrhage, organ injury, or wound failure) in patients who undergo elective daytime surgical procedures performed by attending surgeons who had less than a 6-hour opportunity for sleep between procedures during a previous on-call night.

Note that this relates to elective surgery – you elected to have it; it is not an emergency. Sure, if the surgery has to be rescheduled, that’s a major inconvenience and not emotionally satisfying after you have prepared yourself for the “magic hour” when you are to be taken to the operating room. In most surgeries, you have not been allowed to eat since midnight (NPO status) if you are going to be anesthetized during your surgery. But let me ask – would you rather be inconvenienced or suffer from “a massive hemorrhage, organ injury, or wound failure” – to name but a few of the things that could go wrong at the hands of a sleep deprived surgeon?

The NEJM article reports that “most patients would be concerned about their safety if they knew their doctor had been awake for the prior 24 hours.” I really don’t think they needed a survey to reach that conclusion. Do you?

So how is this risky situation supposed to be avoided? Are you supposed to ask your surgeon: “So did you get a good night’s sleep?” Or – “How you feeling today, Doc? Well rested?” While some more assertive patients might take this approach, way too many, I’m afraid, would just “trust” their doctor to know  better than to operate under such a condition and advise the patient now is not a good time for him/her to do the surgery. In an ideal world, that’s what should happen – but we don’t inhabit such a world now do we? For whatever motivation – some good; some not so good, I sincerely doubt this is going to happen and certainly should not be the standard. In fact, the following excerpt from the NEJM piece addresses this very issue – at least in part:

Chronic sleep deprivation degrades one’s ability to recognize the impairments induced by sleep loss.5 Sleep-deprived clinicians are therefore not likely to assess accurately the risks posed when they perform procedures in such a state, and they should not be permitted to decide whether or not to proceed with elective surgery without obtaining the patient’s informed consent.

That’s a start, but frankly, I’m not really a big advocate of this approach. Obtaining my informed consent? So what happens – I’m told as I’m awaiting my surgery that my doctor has been up all night and the prior day. He then asks, “Are you willing to have your surgery anyway?” I then ask: “Well how are you feeling? Are you up to doing this?” If I get an affirmative response, why should the burden be on me (read: YOU in this scenario) to make a decision if it’s alright to proceed?

I much prefer the primary suggestion of the authors:

As a first step, we recommend that institutions implement policies to minimize the likelihood of sleep deprivation before a clinician performs elective surgery and to facilitate priority rescheduling of elective procedures when a clinician is sleep-deprived. In addition, patients should be empowered to inquire about the amount of sleep their clinicians have had the night before such procedures.

While I say I “prefer” this approach of “implementing policies to minimize the likelihood of sleep deprivation,” I would modify this “recommendation” to read – “to implement policies to eradicate the likelihood of sleep deprivation or in those instances where certain “sleep guidelines” have not been met, to mandate the rescheduling of this elective surgery. Note that the latter part of this “first step” recommendation puts the burden back on the patient “to inquire about the amount of sleep their clinicians have had the night before such procedures.” Same issues; same problems. The patient should not be put in this position. The hospitals ought to be protecting the patient in such situations, not empowering them – whatever that means!

This is a problem whose solution is not that complex. It is a problem whose solution is way too long overdue. I would urge the medical profession and hospital  administrators to stop trying to be “balanced” on this issue. Sure it’s an inconvenience for all concerned. No doubt this can wreak havoc in terms of a hospital’s operating room scheduling. Too bad! Figure out ways to deal with “call schedules” then. Don’t place the onus on the patient. The health industry claims it is constantly in search of ways to improve safety. Well isn’t this a pretty simple issue to tackle if that’s the case?

What are your thoughts on this issue? Would you be concerned if the person holding the surgical instrument for your procedure has sleep deprivation? Would you ask the questions about their sleep patterns or how much sleep they got the night before? Should this be a patient’s burden? What policies make sense? Share your thoughts with our readers. Maybe – just maybe – the right people might read your comments and come up with some solid policies to protect all of us in such circumstances.

Image: peoplespharmacy.com

Study reveals “staggering” statistics on Medicare patients who will die or be readmitted within one year of stroke

Wednesday, December 22nd, 2010

Today I came across an excellent post in theheart.org entitled “Death and readmission rates after stroke “staggering” for Medicare Patients.” As a general comment, if you are not familiar with this online journal, I would strongly recommend you register (it’s free). They post a number of excellent pieces on a consistent basis.

Dr. Gregg Fonarow and colleagues did a study examining the outcomes for 91,134 Medicare patients, who had suffered an ischemic stroke between April 1, 2003 and December 31, 2006. The researchers themselves described their findings as “staggering.” Here is the essential finding:

Almost two-thirds of Medicare beneficiaries discharged from the hospital after suffering an ischemic stroke die or are readmitted within a year.

Does the type of hospital make a difference?

While ostensibly not the major focus of the study, Dr. Fonarow’s research team did examine data to determine if the outcomes were significantly better if the patient was seen for the initial acute ischemic stroke at an academic center versus a non-academic (e.g. community hospital). The finding in this regard was not what I expected.

Rates were only slightly lower for academic hospitals than nonacademic centers. “That was surprising,” said Fonarow. “Whether a hospital was academic or bedside or, more important, a joint commission primary stroke center really did not make a large difference in outcomes.”

The impact on the healthcare system is obvious and alarming

I don’t claim to have any expertise in statistical analysis or application of such data to a system-wide root cause analysis. That being said, does it really take a statistician or mathematician to grasp the import of this “staggering” data? If you or someone you know is on Medicare and has suffered an acute ischemic stroke, there is a 2 out of 3 chance you (or the person you know) will be readmitted or die within one year of suffering that stroke!

The big questions: Why and What can be done?

Dr. Fonarow readily admits that the data he collected does not lend itself to the ultimate answers. What he does note, however, is that while further studies are clearly warranted, since more than one-half of the cases for readmission analyzed involved non-cardiovascular causes, “there’s room for better secondary-prevention efforts.”

“When you looked at causes of readmission, in many cases it was not a recurrent stroke or cardiovascular event but other comorbid conditions, such as pneumonia, falls, and GI bleeds,” he said. “It shows you that when caring for someone after a stroke, managing these comorbid conditions and related risks is going to be critical.”

He added that the period after discharge for an ischemic stroke offers a “window of opportunity” for interventions to reduce the burden of post-ischemic stroke morbidity and mortality.

The information shared by Dr. Fonarow is unequivocally “staggering.” One can only hope that further system-wide studies are performed soon to identify what improvements can and need be made in the delivery of health care to this population to reduce such loss of life and burden on the healthcare system secondary to readmissions.

What’s your reaction to Dr. Fonarow’s study? Are you aware of any data that is known for death and readmission rates in the non-Medicare population? If there is a significant difference in death and readmission rates between Medicare and non-Medicare patients, what is being done in the non-Medicare population that can be adopted for all patient populations?

Image from mountnittany


DARVON AND DARVOCET WITHDRAWN FROM U.S. MARKET – WHAT SHOULD YOU DO IF YOU ARE TAKING THESE MEDICATIONS?

Tuesday, November 23rd, 2010

Last week, the manufacturer of Darvon and Darvocet, Xanodyne Pharmaceuticals, agreed to withdraw these drugs from the market in response to FDA requests.  The FDA has also requested that generic drug manufacturers also stop marketing propoxyphene-based pain killers like Darvon and Darvocet. These drugs were withdrawn from the U.K. market almost six years ago. About a year and a half ago, the European drug agency also placed a ban on propoxyphene-based pain killers. An estimated 10 million Americans are taking propoxyphene-based drugs.

Although propoxyphene was always associated with a number of complications, the FDA’s request was prompted by new studies revealing the drug’s serious cardiovascular side-effects. The FDA was petitioned on a number of occasions to pull propoxyphene off the market. The latest petition came from the public interest group Public Citizen in 2006.  The FDA submitted the petition to an expert advisory committee that voted in favor of withdrawing the medication in 2009 (14 to 12 ).

The FDA did not request that the medication be removed from  the U.S. market in 2009. Instead, it requested that the manufacturer of the drug, Xanodyne Pharmaceuticals, Inc., conduct research to study the effects of the drug on the heart. This new research revealed that people taking propoxyphene (Darvon, Darvocet and  the like) can develop abnormal or fatal heart rhythm.  These findings prompted the FDA to request the withdrawal of the medication. Propoxyphene is also associated with the following cardiovascular complications:

  • Tachycardia
  • Cardiac/respiratory arrest
  • Congestive heart failure
  • Myocardial infarction
  • Hypotension

Some other side effects include:

  • Drug overdose/toxicity
  • Drug dependence/withdrawal
  • Anxiety
  • Nausea
  • Vomiting
  • Drowsiness/ dizziness
  • Hives
  • Difficulty breathing
  • Chest tightness
  • Swelling of the face, mouth, lips or tongue

The Public Citizen group has claimed that about 2000 people in the U.S. have died as a result of propoxyphene in the last six years. The good news for those taking Darvon, Darvocet or a similar drug is that the cardiovascular side effects of these drugs are not cumulative. Therefore,  the risk of developing cardiovascular problems should go away once the drug is stopped.

If you are taking Darvon or Darvocet, DO NOT stop taking the drug until you talk to your doctor. Sudden interruption of the medication can lead to serious withdrawal symptoms.  If you are taking propoxyphene-based medications, contact your doctor immediately so that you may be transitioned to a safer pain killer.

Photo: pharmer.org