Dec 27 2008

Perils of Colonoscopy Prep, Electronic Medical Records Update, and Cold-hearted Insurers

Nobody looks forward to a colonoscopy, but based on anecdotal evidence, the preparation is usually worse than the procedure.  Consuming large amounts of drugs that expel every last bit of waste from your colon so that your physician can get the unobstructed views necessary for the procedure is simply not fun.

But, did you know that the prep could be dangerous?  According to a May 5, 2006 FDA MedWatch Alert, a rare but serious reaction can occur when patients are given oral sodium phosphates (such as Fleet Phospho-soda or Fleet ACCU-PREP) for pre-colonoscopy bowel cleansing.  Acute phosphate nephropathy (renal failure) is a risk of the drugs, but individuals considered to have an increased risk are: the elderly, those with kidney disease or decreased intravascular volume, those using drugs that affect renal function or perfusion, ACE inhibitors, ARBs, and possibly NSAIDs.  Maybe you did not know this.  However, your doctor should know about it.  Since that alert was issued, any physician who instructed a patient in one of the risk groups to take the medications may be liable for medical malpractice, if the patient suffered kidney failure as a direct result.

More recently, the FDA announced, on December 11, 2008, that it is placing a Boxed Warning on the prescription oral sodium phosphate drugs Visicol and OsmoPrep alerting consumers to the risk of acute phosphate nephropathy.  The announcement recommended that patients no longer use over-the-counter OSPs for bowel cleansing.  (hat tip to my colleague, Thomas Valet, Esq., for alerting me to the OSP-related news)


Electronic Medical Records get a fresh, and decidedly American look in today’s NY Times.  Reporter Steve Lohr puts the spotlight on the Marshfield Clinic, in Marshfield, Wisconsin, to show how the instant accessibility of complete and regularly-updated electronic patient-care records improves the safety, and the delivery of healthcare to patients.

Mr. Lohr reports that President-elect Obama is on board with the idea of bringing further computerization to the American system of healthcare.  “Mr. Obama vowed to spend $50 billion over five years to spur the adoption of electronic health records and said recently that a program to accelerate their use would be part of his stimulus package.”


And finally, some depressing news with which to end the year.  Did you ever notice how your health insurer “loses” the claim sheets you send in, or finds nifty little ways to make sure you get little to no reimbursement for the medical procedures you need?  Well, consider yourself relatively lucky.  Or at least luckier than the family of a 17-year-old girl in California who was diagnosed with leukemia, and has since died, partly because the family’s health insurer, Cigna, reportedly rejected valid claims and delayed acting on those they deemed legitimate, so that a potentially life-saving liver transplant was approved too late to do any good for the patient.  The story was reported by the AP in today’s NY Times, at A-11.


Have a wonderful, safe and happy New Year.


5 Comments on this post


  1. throckmorton said:

    In your statement about phosphate nephropathy, “any physician who instructed a patient in one of the risk groups to take the medications may be liable for medical malpractice, if the patient suffered kidney failure as a direct result.” I wonder, since this is a very rare effect, are physicians to be held liable for all rare side effects? Further, why is this malpractice? Another example is that we know that any patient who goes on an antibiotic is at risk for stevens-johnson syndrome which causes renal failure. If a patient does get this is it malpractice? These are the lines that are blurred in courts. We need a defined “Standard of Care” that is evidence based to figure this out. If we want to make every rare side effect a grounds for malpractice, there will be no medications or procedures left.

    What do you think?

    In regards to the health insurance complanies, I think you hit is right on the head. It seems that the rule of sevens still applies. At the medical office level, some insurnace companies drop every seventh claim or at least delay it by changing the criteria or the claim processing programs. They then will change the diagnostic criteria to add further delays. All these are designed to delay the payment of the claim and to increase the interest obtained from your healthcare dollars. They know that the more hurdles that you have to jump through, the more likely you are to give up. Cigna has settled a large class action suit for this process. It is however still standard practice for most health insurance companies.

    December 27th, 2008 at 9:52 am
  2. Andrew Barovick said:

    I think that in light of the May, 2006 FDA alert, a physician would need to have a very good reason to tell a patient in one of the increased risk groups to take oral sodium phosphates for colonoscopy prep. Even though the adverse reaction is rare, it happens, and it is more likely to happen to those at increased risk. Assuming the OSP causes acute phosphate nephropathy in such a patient, I think that constitutes medical malpractice. In these circumstances, there would likely be an issue regarding informed consent as well.

    In the stevens-johnson syndrome cases I have seen, the physician had no way of knowing that the medication would bring it about. The real issue in those cases, from a medical-legal standpoint, is how quickly the reaction is diagnosed and treated.

    December 27th, 2008 at 1:33 pm
  3. throckmorton said:

    Thank you for addressing the above comment. Why I am concerned about these rare effects being considered malpractice is that rare side effects do occur. OSP nephropathy is exceedingly rare, other side effects are not. When we look at antibiotics, we know that certain patient populations with get C. Diff colitis which can also lead to renal failure. Where is the line? I guess what I am trying to say is that there is no way that you can possibly tell people all the possible side effects of medications. Aspirin alone will take hours.

    This is why we need a true “Standard of Care”. Something that we can rely on to help with this type of issue. Something that addresses what is or is not possible.

    December 28th, 2008 at 7:43 am
  4. SeaSpray said:

    Health insurance companies should be held accountable when they withhold or limit care that results in injury or death. SHAME on them!

    I am opposed to suing wrongfully, particularly when the physician or anyone else was trying to HELP someone.

    I know people who could have sued doctors with open and shut cases, but didn’t and I respect them so much. It took one doctor awhile to believe she wouldn’t and she never did.

    I don’t say this lightly.

    But in this case… they should pay DEARLY. Not only should they pay a settlement… but they should be fined in addition to paying out on the claim… and THAT money should go into a fund set up to help sick people or some worthy cause. I know…rebates to the providers and subscribers! OUCH! That would hurt.

    Not only should they be sued and pay out big time, pay a hefty fine…proportionate to their egregious disregard for their subscriber’s health needs… they should then go on some public black balling list that alerts both prospective subscribers and providers of their payment history and how many fines/penalties they have received.

    Hurt them in the wallet… and perhaps they will do what people in good faith believed they would do in the first place.

    That poor family!

    And how many times do these things go on under the radar?


    Regarding suing physicians for “possible” side effects… they aren’t God. They can’t possibly know every possibility.

    I think if there is a known risk because a patient is physically compromised in some way…then yes…the doctor needs to be aware of things that could potentially harm the patient, explain the risks and pursue other alternatives if necessary or possible. But I am guessing the incidence of bad outcomes is rare and so what do you do then?

    I guess it comes down to the lesser of the 2 evils. But … if the pt doesn’t get the colonoscopy because of the prep risks and develops cancer…then the doc will be sued for not doing it.

    It’s a crap shoot! (No pun intended)

    I suppose this might be a good argument for state of the art EMRs so that all pertinent patient info is readily available to the physicians who need an accurate and comprehensive medical history since patients don’t always think to include all important information when seeing a new doctor. (That being said…I hate the idea of my personal info being at someone else”s finger tips, but I digress.)

    December 29th, 2008 at 2:43 pm
  5. SeaSpray said:

    P.S. maybe the employee that denied the claim…or ultimately responsible for denying the claim and stalling should also have to pay a fine. Not a lot… but they should know that their actions caused another human being to suffer and or die needlessly.

    Then again… maybe if they were trained that way…they don’t fully appreciate the consequences of their actions. But they should.

    There needs to be more public awareness about these issues.

    December 29th, 2008 at 2:48 pm


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