Archive for January, 2011

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

Follow-up Blog: Important questions and answers on Pradaxa

Monday, January 10th, 2011

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Ovarian Cancer – Early Intervention is Key, What You Must Know…

Monday, January 3rd, 2011

According to the American Cancer Society, about 22, 000 women are diagnosed with ovarian cancer in the U.S. each year; about 14,000 of these patients will die as result of their cancer.  It is most noteworthy that the five-year survival rate is 90% when ovarian cancer is diagnosed before it has spread beyond the ovaries.  Yet, only about 20% of ovarian cancers are detected in the early stages.

Screening, more screening, monitoring and an understanding of the signs and symptoms of ovarian cancer are key to early detection.  A myth that must be dispelled is that cervical cancer is the same as ovarian cancer.  Just because a patient has a normal pap smear, does not exclude the possibility of ovarian cancer. Simply put, the pap smear test has nothing to do with the diagnosis of ovarian cancer. Unfortunately, recent studies suggest that many women rely on their normal pap smear result to conclude that they do not have an ovarian problem.

It must also be understood that what some doctors loosely characterize as an ovarian cyst does not necessarily exclude the possibility of ovarian cancer. If your doctor tells you that you have an ovarian cyst because of a mass identified on ultrasound, make sure to inquire about the basis for the conclusion that the mass is”just a cyst.” Sometimes the ultrasound is the only study performed to identify the mass.  As great as ultrasounds are, they are not always the most accurate studies.  This is particularly true for patients who are obese or overweight. Radiologists will often read ultrasounds in such patients as limited because of “body habitus” (the physique of the patient). Keep in mind that most of these ultrasounds are performed in clinics, and they are read by obstetricians, who are not trained radiologists. You must ask your physician if the mass is a solid mass or a mass filled with fluid. If it is a solid mass or your physician cannot answer the question, you may want to consider further studies. Don’t let your physician simply guess that the mass must be a cyst because of its size or because of some general statistical probability. In any event, both cysts and solid masses require further monitoring.

The symptoms of ovarian cancer include but are not limited to:

  • Swollen abdomen
  • Unusual or excessive vaginal bleeding
  • Pelvic and/or abdominal pain and/or heaviness
  • Back pain
  • Unexpected weight gain or loss
  • Increased urinary frequency or urgency
  • Lethargy
  • Constipation
  • Indigestion
  • Nausea and vomiting

If you and your physician suspect ovarian cancer, the following are useful diagnostic modalities:

  • Alpha fetoprotein
  • Blood chemistry
  • CA125 (may be done if ovarian cancer is strongly suspected or has been diagnosed, and to follow the cancer during or after treatment)
  • CBC
  • Quantitative serum HCG (blood pregnancy test)
  • Urinalysis
  • Abdominal CT scan or MRI of abdomen
  • GI series
  • Ultrasound
  • Pelvic laparoscopy
  • Exploratory laparotomy

If you are experiencing these symptoms, you may want to address the possibility of ovarian cancer with your physician.  Some physicians will generally perform an ultrasound. If they are not impressed with the ultrasound, they may not pursue any other diagnostic modalities.  If the ultrasound reveals a mass, some physicians may elect to wait and perform a follow-up ultrasound in a few months.

Notwithstanding how aggressive your physician is to rule out ovarian cancer, remember that physicians rely on your feedback, and you alone truly know the extent and severity of your symptoms.  Depending on your clinical presentation, waiting for 3 or 6 months for a repeat ultrasound may be unacceptable. Ovarian cancer can spread quickly within a matter of a few months from a stage I cancer to a stage IV cancer.  Take the initiative to fully explore all available diagnostic modalities with your physician. Don’t be uncomfortable asking your doctor for additional diagnostic tests or more frequent monitoring.  The worst thing you can do is become a passive participant in a complex and stressful process guided by a physician, who may not fully appreciate the extent and severity of your symptoms.

If you are an ovarian cancer patient, share your story with our readers. How long did it take for you to find out you had ovarian cancer? In retrospect, what would you have done differently as a patient?

Related Blogs:

New study links gene to ovarian cancer and may assist in early detection
Ovarian Cancer – The Smear Test Won’t Tell You Much