Showing posts with label QTc prolongation. Show all posts
Showing posts with label QTc prolongation. Show all posts

Tuesday, March 31, 2015

No Information From The EHR - An Ongoing Problem




Like most physicians - I like the concept of an electronic health record (EHR).  It is just that the real EHR as it exists is a far cry from the concept.  The proponents of the current EHR,  especially those who want it mandated by legislative activity continue to brag about the savings and all of the benefits.  Any physician looking for information or an ability to enter and move information without ending up in a click fest of mouse clicks knows the reality.  Any physician looking for a note that reflects an intelligent conversation between a physician and a patient is also left wanting.  Reading the electronic or printed out version of the EHR usually results in very choppy documentation.  Lists that are the result of not very intelligent coding by EHR IT engineers, notes produced strictly to meet billing and coding bullet points, and notes produced because they could be rapidly compiled with features like smart text.

All of this can be a nightmare for a compulsive physician like myself who wants to use all of the relevant information in patient care.  My career has been treating patients with complex medical conditions who are also on complicated combinations of medications.  Many have known heart disease and take combination of medication that can adversely affect their cardiovascular status and interact with psychiatric medications that I prescribe.  All of that needs to be considered.  Since ziprasidone (Geodon) hit the market in 2001, psychiatrists have been preoccupied with the QTc interval.  The QTc interval is the electrical interval that corresponds to the contraction and relaxation of the left ventricle.  In cases where this interval is too long it predisposes the patient to ventricular arrhythmias some of which are potentially fatal.   The FDA had a warning on ziprasidone about the potential for QTc prolongation and subsequently came out with warnings about citalopram.  In the course of clinical practice, many psychiatrists had already encountered this issue with older antipsychotic medications and tricyclic antidepressants.  The FDA makes these pronouncements but gives physicians no guidance on what to do about the clinical situations.  I have a practice of looking at ECGs and any Cardiology evaluations that have been done.  That is the only way the QTc interval can be determined and even then there are various factors that can affect it.

Rather than order an ECG, I will ask whether they have already been done and get the patients consent to have them faxed to me.  That result is frequently disappointing, especially in the case of the EHR.  I will often get a series of cryptic sheets, that look like a sparsely populated medical record.  There are often no coherent notes from physicians or if they are there, they do not contain standard information that I am looking for.  I have never seen an ECG tracing contained in these stack of records.  The best I can hope for is a brief note that lists an impression like "NSR - no acute changes."  An added bonus would be an actual description of the critical intervals.  For the tracing at the top of this page it would say:  "PR interval - 164 ms; QRS duration - 100 ms; QT/QTc - 434/415 ms."  That is really all of the information I need to know.  But the most important issue with the EHR is that all of this visual information is usually lost, unless I submit a second or third request and it usually has to say "send me the ECG tracing."  The medium that purports to provide a lot of information to physicians and put it at their fingertips is a bottleneck.  By the time I see the information I need to see, it is not necessary.  I have moved on and not recommended a treatment that I could have recommended if the ECG was normal.  That practice has been reinforced by getting an ECG after the fact and realizing that not only was there a prolonged QTc interval, and it was read that way by a Cardiologist but reported as "normal" in the EHR.

I will be the first to admit that there is minimal evidence that my tight QTc surveillance has saved any lives.  But my threshold is really to prevent any complications.  I am not treating acute heart conditions.  I am trying to make sure that I don't cause any by the medications that I prescribe, by ignoring a critical drug interaction, or by not recognizing the significance of a patients physical illness and how it needs to direct the therapy that I prescribe.

That doesn't end at ECGs.  I would throw in imaging studies (CT and MRI), EEGs, and even routine labs.  If the EHR is supposed to convey the maximum information why wouldn't all of the visual information of an episode of care be included?  Why can't all of the brain imaging studies be sent along as a disk or e-mailed to me?  Why do I have to read a 200 page fax and try to reconstruct all of the lab results  in a coherent manner that are spread randomly across those pages so that I know what happened in the hospital?

The EHR as it currently exists is a tremendous burden to physicians.  It takes far too long to enter data and quality notes about care are rare.  If you happen to lack online access to the program where the record is constructed, good like trying to piece together the information that you need for clinical decision-making.  Politicians are good with ideas, but none of them seems to be aware of the real problems that exist in these systems.  Despite that lack of knowledge they continue to insist on the wide implementation of these systems and that is really a tax on physicians that is being used to subsidize the development of EHRs and fund this industry.

Hopefully that will pay off someday, but the current problems have been there for at least a decade and there are no signs that they will be going away soon..



George Dawson, MD, DFAPA  

Friday, November 23, 2012

Mayo Clinic Counterpoint to FDA on Citalopram

The Mayo Clinic came out with their recommendations on what to do about the FDA's warning about citalopram.  By their own description they are more liberal with regard to their citalopram recommendations and more conservative regarding escitalopram.  I have previously reviewed the problem here and concluded that there is really a lack of data available on the likelihood of electrocardiogram abnormalities during normal clinical use and if citalopram is as cardiotoxic as the FDA is describing it - we should treat it more like a standard antiarrhythmic drug and used flecanide as an example.

For all practical purposes that would include baseline ECGs, ECGs at the max dose and taking it up one more level from either the Mayo Clinic or the FDA - a stress test looking for QTc prolongation at higher heart rates.  The other elements in the Mayo recommendations based on history and physical examination and expecting some physician knowledge of drug metabolism are fairly standard.  I thought it was interesting that they did not mention checking plasma levels of the drug especially in complex cases (eg. a patient with cirrhosis) who only responds to higher than recommended doses of the drug.  Regarding the statements:  "Selective serotonin reuptake inhibitors cannot simply be substituted for one another, not even escitalopram for citalopram."  That is generally true and where are these guys in the battle against PBMs saying that these drugs are all equivalent?  I have not found any patient that responded selectively to citalopram and not escitalopram.  I have generally been able to convert patients to an equivalent amount of escitalopram the next day.

Both the Mayo Clinic and the FDA are silent on molecular approaches to solving this problem and screening patient for potential risk before they are started on either drug.  The Mayo Clinic offers testing for cytochrome P450 genotypes.  The genetic basis for hereditary prolonged QTc intervals has been a hot topic of research over the past decade.  It is probably time to expand the search for additional genotypes that place people at risk during specific drug therapies.  Until then we have only very approximate methods of determining the at - risk population and keeping them safe and the Mayo recommendations are more reality based than the FDA.

I think it would also be possible to estimate the risk associated with taking citalopram across the entire population.  In fact, at this point the FDA seems to have the data to estimate the risk of any QTc effect at all to the risk of torsade de pointes - the most significant arrhythmia.  I think it is very important for patients making the decision to have this number and if I can provide numbers on rare but serious antidepressant complications like serotonin syndrome, a federal agency with more perfect information and no patient care responsibility can do better.

George Dawson, MD, DFAPA

Sheeler RD, Ackerman MJ, Richelson E, Nelson TK, Staab JP, Tangalos EG, Dieser LM, Cunningham JL. Considerations on safety concerns about citalopram prescribing. Mayo Clin Proc. 2012 Nov;87(11):1042-5.

FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses.