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Risks of Defensive Medicine

January 25, 2012

There has been a lot of criticism of defensive medicine as a major contributor to the rapidly rising high cost of medical care in the United States.  Although the real financial cost of defensive medicine is one issue, it is not the only problem with defensive medicine.  Defensive medicine also has the risks of incidental findings on tests that are unnecessarily ordered, the risks patients encounter due to evaluation and treatment of these findings, and overdiagnosis.

Screening for prostate cancer has been all over the news recently, with the USPSTF proposed recommendation against routine PSA screening, and is a classic example of the risks of screening tests. The strongest argument against PSA screening is overdiagnosis and exposure of men to invasive prostate biopsies, and potentially dangerous therapy for prostate cancers that will never become clinically significant in some unknown but likely high percentage of cases. One of the primary reasons I don’t anticipate a dramatic reduction in PSA testing in primary care is because it is perceived by physicians that they are much less likely to be sued for complications of care caused by overdiagnosis of prostate cancer than if a patient is diagnosed with advanced prostate cancer and who has not been offered PSA screening. I suspect at least some physicians are going to be afraid to do the right thing even if they are convinced that the evidence supports not doing PSA screening.

Far less emotional and dramatic are consequences of defensive medicine precipitated by the ordering of imaging tests. It is commonplace for a physician to order an MRI of a patient’s knee early in the course of management of a knee injury.  In an NEJM study of randomly chosen men without a complaint of knee pain the incidence of finding a meniscus tear on knee MRI was 31%.  A finding of adrenal masses on abdominal CT scan is very common.  In one study the incidence of an adrenal mass finding on abdominal CT in patients without a known malignancy was 5%. In this same study of 973 consecutive patients of the 973 zero were found to be malignant.  This is exactly my experience, i.e. I’ve never had one of these turn out to be a cancer. Yet once an adrenal mass is found it is almost always recommended as a part of the radiologists report to have it reevaluated at least one, often twice or more to assure “stability.” It is unusual for a primary care physician not to order these follow up tests, more defensive medicine.  The risk of radiation exposure from abdominal CT scanning is not insignificant.

Treatment of sore throat, acute short-duration sinusitis, otitis media and acute bronchitis with antibiotics is very common.  It may be defensive medicine or just taking the path of least resistance, but there are very real risks of antibiotic therapy and almost all the evidence and expert opinion argues against the use of antibiotics in these conditions. With the increasing incidence of Clostridium difficiele infections, and increasingly virulent and antibiotic resistant C. diff as well as the other risks of side effects of specific antibiotics their use is far from risk free.

Nearly every new highly sensitive imaging technique is also very good at finding incidental variations of normal and abnormalities for which radiologists are reluctant to recommend no further evaluation, This is defensive medicine on the part of radiologists, as well as good business on their part in our fee-for-service environment.  What business person of sound mind is going to put themselves at legal risk and at the same time recommend against a test that is in their financial interest.  The risk to patients is more than just the risk of further radiation.  Often the tests also lead to invasive tests or treatments, all of which have their own risks.

Many blood tests have the same risks, including tests like CA-125 for ovarian cancer, of course PSA, but also things as simple as a CBC. A CBC with a low white blood cell count is usually either normal or the result of a recent viral illness. Still it usually leads to a follow up test to assure a return to normal. If it persists low it may lead to referral to a hematologist who often orders a bone marrow evaluation.  These are not only moderately painful but can have uncommon serious complications.

Essentially every test or procedure we do entails some risk. Ordering tests for defensive medicine reasons when the chances of finding clinically important and helpful results is fairly low makes the chances of finding false positives or overdiagnosis and leading to complications that would never have happened if the testing had not been done relatively higher. The cost of defensive medicine is not just in dollars.

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Doctors Die Too, but Maybe Differently

January 23, 2012

I stumbled across this terrific article titled:

How Doctors Die by Ken Murray a FP at USC.  

It is largely anecdotal, but is a really an interesting perspective on how at least some physicians choose to forgo futile end-of-life treatments because they know the limits of modern medicine first hand.

Also Enjoy:

Octogenerian’s Letter to Santa

 

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Robotic Surgery Today

January 20, 2012

I’ve known for some time but have recently become focused on robotic surgery since my wife is having a robotic surgery today. The idea of robotic surgery makes it seem like a robot is somehow doing surgery better than a surgeon could. In fact that’s not the case at all; rather the robot allows the surgeon doing laparoscopic surgery to have an advantage over using traditional open surgery or manual laparoscopic surgery to accomplish difficult surgeries. As many surgeons have become more experienced with robotic surgery the hope of superior results with less collateral tissue damage and reduced recovery time makes robotic surgery an exciting new tool in the surgical management of many diseases.  Robotic surgery has become commonplace in surgery for prostate cancer and several gynecologic procedures, but also for conditions as complex and diverse as cardiac valve replacement to rectal cancer.

The Da Vinci robot is a machine that allows the surgeon to use stereoscopic cameras letting the surgeon get closer looks at the tissues they are operating on, and to use joy-stick like controls to maneuver surgical instruments to accomplish the dissection, ligation of vessels, and suturing necessary to accomplish the surgery. This can in the hands of skilled operators give the ability to use a laparoscopic approach with superior equipment, visibility and using the robot can avoid human tremor to achieve better results than with laparoscopy using surgeon’s hands to control the instruments directly.

There is a moderate amount of evidence that robotic surgery causes less tissue trauma and faster recoveries.  Like all procedures there is a learning curve with robotic surgery. In the early days of robotic surgery a major problem was the increased duration of procedures subjecting patients to prolonged anesthesia, and the expected mistakes and misadventures of learning a new technique.  Now that many surgeons, including ours, have done hundreds and even thousands of robotic surgery procedures the duration of procedures approaches the duration of open and traditional laparoscopic surgeries.

Let’s pray that Kay’s surgery today will be one more successful example of robotic surgery.

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Endemic Polio: Good News and Bad News This Week

January 18, 2012

The Polio news this week was both very good, and potentially very bad. In Early Jan. 2012 India celebrated a year without a case of wild-strain polio, the first in its history and a huge achievement in a country with about a billion people and areas of extreme poverty and remote regions.  Also this week Afghanistan was reported to have a 3-fold increase in the number of polio cases, from about 25 in 2010 to 76 in 2011.  This will be a tragedy if not arrested, as there are only three countries considered still endemic for polio remaining in the world, but the entire world remains at risk until there is a complete eradication.

Afghanistan remains a challenge to immunize both because of it’s remote areas and because of its civil war.  The Taliban are reported to have remained cooperative with immunization efforts, but in any country at war coordination and extraordinary safety measures must remain a constant barrier.

A nice article in the N.Y. Times discusses this issue and is worth the read:

After Years of Decline, Polio Cases in Afghanistan Triple in a Year

As a Rotarian and contributor to Polio Plus this remains an interest of mine.  Also see previous posts on this topic:

Polio Eradication

Eradication of Polio: It’s Happening

 

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Latisse: Are Longer Lashes Worth the Cost and Risks?

January 13, 2012

I find the most interesting thing about Latisse® is how it came to be used for growing longer thicker eyelashes.  Latisse follows a familiar story like other hair growth products in that it was an incidentally discovered side effect/benefit of the active ingredient in Latisse® while it was being used for another indication. Latisse® got its FDA approval in December 2008, and was brought to market after discovering that the active ingredient in Latisse® called bimatoprost which was used as an eye drop for glaucoma was incidentally noted to lead to longer thicker eyelashes. This quickly led to a medical diagnosis in order to give an indication for a new drug. The medical term, or if you prefer medical diagnosis, for shorter or thinner than desired eyelashes is hypotrichosis of the eyelashes.  Latisse® follows the list of other drugs which were incidentally noted to cause hair growth, Rogaine makes use of minoxidil, a seldom used oral medication for refractory hypertension that was noted to cause undesired hair growth when taken orally. Propecia uses the active ingredient finasteride (brand name Proscar®), which is used to shrink the size of the prostate and allow men with benign prostatic hypertrophy to urinate more easily. It was found later slow male pattern baldness hair loss and is now commonly used for that purpose.

The exact mechanism of action of Latisse is not clearly understood but it appears to be a prostaglandin receptor binder . Prostaglandin receptors are present in here and is thought that prostaglandin receptors are somehow involved in the development and regrowth of hair follicles.

Latisse® is a prescription only product that is designed to be applied once daily to the base of the upper eyelashes with a single use a sterile applicator. Despite the intention to make Latisse® prescription only,  much like other drugs for which patients might wish to use but don’t want to get a prescription to see a physician about Latisse® is widely available online without direct physician supervision. This is unfortunate because the teeth can have very annoying and potentially permanent side effects. These include a plum shade discoloration of the eyelid, macular edema which can be very serious even lead to blindness, a condition called punctate epithelial keratitis which can lead to significant itching and irritation of the eyes, as well as dry eye, eyelid swelling and injection of the conjunctival blood vessels making the eye seem reddish or pink. In addition though not mentioned in the product insert there are reports of Latisse® leading to darkening of the iris.

Although Latisse is a prescription only product it’s very easy to purchase this drug online without a prescription. The top of the Google search list for pilot case online is a site where you simply submit a medical form history and a “patient marks licensed physician will carefully ensure Latisse is a safe  option free you to use before we send your order.” They even advertise a discount for Valentine’s Day few by two more bottles. The retail price@drugstore.com for one bottle for peace is $115.99, but several online sources appear to be selling Latisse for between $70 and $85 per bottle. A bottle will last one month if applied as directed to both upper lids and even the manufacturer notes that Latisse only works as long as you continue to use it. Whether longer thicker eyelashes are worth approximately hundred dollars a month plus the risk of serious side disorders that could even affect vision and cosmetic or annoying eyelid problems is for each individual to decide.

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Statin Side Effects: Add Type 2 Diabetes?

January 11, 2012

Statin Side Effects: Add Type 2 Diabetes?

I want to weigh in briefly on all the headline news on the review in the online Archives of Internal Medicine about the increased incidence of type 2 diabetes in older women taking statins.  In this analysis of the data from the Women’s Health Initiative an increase of about 50% in the incidence of new cases of diabetes was found in women taking a statin when compared to women not taking a statin.  At first glance this sounds terrible.  Giving people at high risk of cardiovascular disease a drug that increases their risk of developing diabetes when the leading cause of death in diabetic patients is cardiovascular disease may seem odd.

For me this is really a call to reason.  I hear jokes about putting statins in the water supply as if they are a magic medication that patients really need a reason not to take.  The bulk of the evidence is clear that statins are indeed a terrific class of medications. In patients with cardiovascular disease, and in patients at high risk of cardiovascular disease, statins have proven to reduce rates of death and cardiac events like heart attack and stroke in study after study.  Still, even drugs with all the positive outcome data of the statins is not without risk.  The potential for statin side effects especially myalgia are well-known. Now we can probably add an increased risk of developing diabetes to the long-term statin risks.

I suspect that when the dust settles on this issue we are going to continue to encourage the use of statins for patients with elevated LDL cholesterol when their whole profile of risks (looking at other factors like smoking, blood pressure and diabetes in addition to just their LDL cholesterol) puts them at high risk.  I also suspect that we will become more circumspect about advising statins for patients with moderately high cholesterol and few other risks.

It looks like our water supplies are safe from added statins for the time being.  We can probably add an increased risk of type 2 diabetes to the list of statin side effects.

See also:  Simvastatin vs. Lipitor and Any Advantages or is Livalo Just One More Statin?

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The Purpose of Progress Notes

January 9, 2012

As a practicing physician I am responsible for making progress notes to document every patient visit. Over the years I’ve had to prepare progress notes as handwritten documents, as dictated documents that I had a transcriptionist type out, and for the last 15 years as EMR generated progress notes. Throughout this progression of technology in facilitating the compilation of progress notes several things haven’t changed. The first is that some providers really struggle to stay current on completing the progress notes. The use of an EMR seems to be here to stay and I believe the real key to staying current on completion of progress using an EMR as it was with earlier technologies is to do them at the time of the visit or as soon as possible thereafter. Waiting hours or even days before completing your progress notes not only makes it more difficult to make the notes accurate and useful but requires taking time to recall information that if the note had been done at the time of the visit would have been in the provider’s immediate recall. The other thing that has not changed is that whether we like them or not they serve three and I believe only three purposes.

This may seem overly simplistic or even crass but progress notes only serve three purposes:

  1. Facilitate good patient care: The primary purpose of progress notes is to allow the provider and any other providers who may care for the patient the future to have the information they need to accomplish optimal care. In most cases this really is very little information. I remember early in my career a retiring physician asked me if he could send me some of his patients when he retired. I was a bit shocked to see that he kept his entire patient record on a single 5 x 8 filing card. It was written in pencil and he simply erased any no longer relevant information when he needed more room to write a new progress note. If a patient had strep throat he simply wrote  a dated entry: “strep-penicillin.” It was quite clear that the patient had strep throat and was treated with penicillin and that’s really all anyone needed to know to provide good care for the patient. Needless to say although that progress note accomplished this goal it would’ve failed miserably for purposes 2 and 3 below.
  2. Function as a legal document: Another important function of progress notes is to document care in a way that functions as legal document. As a physician today doing what it takes to avoid being sued for malpractice is a daily reality. We spend a great deal of effort and time documenting our care in order to try to make a case that our care meets standards of practice, and make our care defensible in case of a malpractice suit. This part of progress notes is usually simply detailing the history, physical findings and thought process behind treatment plans.
  3. Get paid: In our third-party payment system the amount we get paid is based on the CPT code that we submit to the insurance company. Each CPT code for evaluation management services (this is medical coder talk for office or hospital visits) has documentation requirements to support that level of service. I won’t get into the complexities of this system but one purpose of progress notes is to include the language needed and the bullet points required for the level of service bill.

I think if physicians have a clear understanding that these are really the only purposes of a progress note it helps facilitate efficient charting. It also helps think about what each of our progress notes needs to contain. When a patient is seen for a very low risk condition and a low-level of service is being billed a brief note that documents what’s necessary to provide excellent care in the future is all it’s really needed. When higher levels of risk are involved a more detailed document to function in case of a lawsuit is needed. By deciding what level of service we plan to bill for the visit we can quickly decide how much documentation is needed to support that level of billing. In my experience most of the time primary care physicians obtain the history and to the physical examination required for higher levels of visit than they bill for, and much of this history and physical doesn’t need to be documented in progress notes unless a level of billing is used that requires that documentation.

Use of an EMR can make entering a great deal of information into progress notes very easy and one of the drawbacks of EMR’s is that the progress notes produced tend to be much longer and include information not helpful for patient care. It’s easy to understand why EMR’s are used to do this level of documentation when you look at the advantages of this documentation for purpose number three (Get Paid).  The trick is to leave out information not needed for any of the three purposes above, and not insert lots of EMR generated details just because it’s easy to do and it’s better to have more information that an auditing insurance company, or worse governmental payer wants to see to justify the CPT code submitted.  This excess data can actually detract from the usefulness of the progress note’s function #1.

You may also enjoy: APSO Notes Need to Replace SOAP Notes in EMRs

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HPV Vaccine for Boys Now Recommended

January 5, 2012

HPV vaccine for boys age 11-12 is now recommended by the Advisory Committee on Immunization Practices according to an MMWR report last month. They specifically recommend the use of Gardasil, the quadrivalent HPV vaccine that targets the HPV strains that cause cancers as well as the strains that cause genital warts.  They also recommended the vaccine for use in males age 13 through 21 who have not been previously vaccinated and suggested that males age 22 through 26 may be vaccinated. This is a significant departure from the prior recommendation guidance that the HPV vaccine may be given to it males age 9 through 26 but fell short of recommending its use in this population.

There are several interesting things about this recommendation. First the quadrivalent Gardasil vaccine is chosen over the alternative bivalent vaccine (Cervarix). The obvious reason for this is because the quadrivalent vaccine gives immunity against the type 6 and 11 HPV that cause up to 90% of genital warts. As a family physician and a parent of a male child this alone would be enough reason for me to immunize my son against HPV. Despite this significant benefit of the vaccine, most of the data considered in this decision-making was based on risk reduction of the more serious consequences of HPV 16 and 18 infection. These can include anal intraepithelial neoplasia, various epithelial head and neck cancers, and penile cancer.

The MMWR article discusses the burden of cancer disease in males related to HPV infection. The article states that of the approximately 22,000 HPV 16 and 18 associated cancers in the US each year approximately 7000 are in males. Many of these are oropharyngeal and anal cancers. The incidence of new cases of genital warts each year in the US among sexually active males is estimated at a quarter million.

The MMWR article also addresses the efficacy of the quadrivalent vaccine in inducing adequate immunity. The efficacy in inducing antibodies against all four strains of genital warts was almost 90% in one large study. The reduction in the incidence of genital developing warts in the population who received at least one dose of vaccine was estimated at 68%. A subset of men in this study group who were immunized who have sex with other men was looked at separately.  Their risk for developing anal epithelial neoplasia related to HPV 6 and 11 was reduced by approximately 50%. It seems reasonable to assume that the incidence of straight men getting this immunization will be less likely to carry the HPV 16-18 strains and put their female partners at risk for cervical dysplasia and cervical cancer.

Safety of HPV Vaccine for Boys: The safety data for the HPV for vaccine is very strong. The most common adverse events were mild or at most moderate, and were usually injection site swelling, with many fewer cases of headache and fever. Approximately 40,000,000 doses of HPC for vaccine have been used the United States in the first five years since licensure and no increase in incidence of any serious consequences have been noted. Don’t believe the ranting of fanatics who badmouth this along with many other safe and effective vaccines. Fainting after getting the shot seems to be the most serious adverse outcome and doesn’t seem to be any higher than with any other shot.

Cost of HPV Vaccine for Boys:  At approximately $130./ dose, and $390./ 3 shot series, this is a real concern. Probably the strongest argument against routine HPV for vaccine of males is its cost. Any discussion of the benefits of immunization of males depends greatly on the incidence of immunizations of females. The rate of immunization of females in the US remains much lower than ideal with an estimated 47% of females age 13 through 17 having received at least one dose and only 32% having received all three doses. If a very high percent of females was immunized the risk of males who have female sexual partners acquiring genital warts would be considerably lower. Given the high current prevalence of the HPV virus it seems reasonable to assume that for some time now heterosexual young men will continue to have a significant chance of acquiring HPV virus. The estimates of the cost of per quality adjusted your of life in men vary from $20,000 to under $50,000 based on varying assumptions but unquestionably the cost of HPV vaccination of young men routinely is going to be high.

Why Give HPV Vaccine for Boys So Young?: Parents may ask why immunize my 11-12-year-old boy who I’m quite certain is ingrained have sex for many years. The answer is several fold. The first is that the highest efficacy for prevention of genital warts is in pre-sexual persons. The second is that children immunized between ages nine and 15 had higher antibody titers and therefore presumably better immunity than those vaccinated from age 16 through 26. The bottom line is that boys vaccinated prior to first sexual contact and purred age 15 have the best chance of immunity to genital warts and avoiding contracting them.

So what should you do for your boy?  My recommendation is that you get your son immunized a relatively young age, certainly before age 15 but ideally with his pre-sixth-grade immunizations around age 12. Why so early? Why not is really the better question. The immunity seems to be long-lasting and getting the vaccine for your child while you still have considerable influence over their receiving the vaccine, while you’re still confident that their pre-sexual, and while they’re in the routine of getting other immunizations just seems to make the most sense to me. So is HPV for boys a good choice? My  recommendation:  A strong yes.

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Zohydro: The Next Oxycodone is On the Way

January 3, 2012

A single ingredient sustained release hydrocodone product  to be called Zohydro is currently in phase 3 clinical trials by Zogenix, and if it gets FDA approval is likely to become the next Oxydontin as a drug of abuse and addiction potential.  I watched a segment on the evening news this week about Zohydro, and it is certainly not going to come to market without fanfare.  Experts on the newscast did a pretty fair job of outlining the concerns of Zohydro, the potential for abuse and the issues with high dose single ingredient opioid products.  Opioid overdose is much more likely with drugs where a very high dose of the drug is contained in a single pill.

Oxycontin has a reputation as probably the most abused of the prescription opioids because of its lack of acetaminophen, its high percentage of rapid release oxycodone, and its lack of properties preventing crushing the pills which eliminates the extended release properties and makes it possible to inhale, inject or smoke the drug.  Sometimes known as Hillbilly Heroin, Oxycontin is among the leading causes of prescription drug overdose deaths and opioid addiction in the U.S.

If Zohydro receives FDA approval as a single ingredient, high dose hydrocodone product there is little doubt that it will join Oxycontin as a major drug of abuse.  Proponents of non-acetaminophen opioid pain medications are correct when they state that acetaminophen has its own problems, and especially when too many pain pills are taken to get pain relief the daily acetaminophen dosage can exceed the 4000 mg / day maximum safe dose.  Serious and even fatal acetaminophen liver damage can result.  Still single ingredient opioid products are so prone to diversion, addiction, and abuse that I anticipate that Zohydro, if approved, will quickly become a major drug of abuse.

One thing physicians have on our side now is the Oxycontin experience.  We will be much more skeptical of allowing escalating Zohydro doseage and addiction become commonplace. Still I am not looking forward to one more drug with few advantages and much abuse potential coming to market.

Oxycontin is available in doses of 10, 15, 20,30, 40, 60 and 80 mg tablets.  Using the recommended opioid Morphine Equivalent Dosage calculator available for download at the Agency Medical Directors site, 30 mg of morphine is equivalent to 30 mg of hydrocodone but to only 20 mg of oxycodone (i.e. oxycodone is 1.5 x as potent on a mg for mg basis than hydrocodone).  Using these equivalency ratios it would be expected that Zohydro might become available in doses up to 120 mg per pill.  This would make it highly popular as a drug of abuse, as current hydrocodone products all contain acetaminophen, and maximum hydrocodone dosing even with products with 10 mg hydrocodone and 325 mg acetaminophen are 12 tablets daily, making 120 mg of hydrocodone the maximum daily hydrocodone dosage.

For related articles see:

Oxycontin vs. Oxycodone

How to Spot a Drug Seeking Patient

Oxycontin: What’s The Big Deal

Leave a comment and join the discussion.  Subscribe using the right sidebar e-mail subscription form or follow @DoctorPullen on Twitter.

 

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New Year’s Resolution Help

January 1, 2012

I bet many of you have made New Year’s Resolutions this year.  If you are like millions of others some of your goals include making changes to improve your health.  Here are some articles from this health blog to help you with motivation or information.

America has an obesity epidemic, and likely the most common New Year’s Resolution revolves around some aspect of losing weight or eating healthier.  You may enjoy and learn from: Health Snacks:  Sensible Snacking for 9-5’ers, the Anti-aging-Anti-Inflammatory Diet, and Healthy Fruits – Healthy Vegetables.

After losing weight or eating healthier quitting smoking has to be among the most common New Year’s Resolutions. For more incentive see:  Why Quit Smoking and Excess Death.

Exercise likely follows closely behind these two, and has advantages far beyond weight control.  Lot’s of evidence supports regular exercise in prevention and treatment of depression and anxiety, improved cardiovascular and bone health, and self-image.  Enjoy: The Unexpected Benefits of Running and Benefits of Resistance Exercise.

I hope all of you choose to take each day of this coming year and make it the best day that you can.  I wrote about this in Carpe Diem, one of my favorite sayings.

Thanks to all of you for following DrPullen.com and for your comments and encouragement.  I continue to enjoy this forum for sharing my thoughts, and one of my New Year’s Resolutions is to find more and better guest columnists to add variety and talent to the posts.  I also need your input to guide me to writing about topics you want to hear about. Let me know in the comments below if you have subjects you’d like to see addressed here, and I’ll try to choose some of them for articles and inspiration.

Happy New Year to all.

 

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