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ศุกร์, 05 พฤศจิกายน 2010
Hello, this is Dr. Jeffrey Lieberman of Columbia University speaking for Medscape. The title of this commentary could be, "Physician, Protect Thyself." Recently, I recorded a Medscape blog in which I commented on being very disappointed to see advertisements by personal injury lawyers, looking for patients who had taken second generation antipsychotic drugs like Seroquel® or Zyprexa®. They were seeking clients on whose behalf they could file lawsuits.
On the basis of this, I described how physicians need to be aware of the predatory nature of these legal practices and ensure that there is adequate documentation of the rationale for using these treatments and how to advise patients about the potential risks for the medications they are about to receive.

Recently, I was reading the newspaper and saw the report of a settlement between Novartis and the US Justice Department for improper marketing practices for the use of Trileptal® off-label. This follows in the wake of settlements by other pharmaceutical companies with the US Justice Department and the US Food and Drug Administration (FDA), including Lilly, Pfizer, and Astra Zeneca, for infractions in terms of marketing practices for the use of medications, and non-FDA indicated uses (off-label uses).
This raises another aspect of the vulnerability that physicians have to potential legal actions. I just wanted to amplify that concern and tell people my thoughts on that and hope that it can be useful, in terms of protecting physicians' practices against such consequences. Basically, we treat patients with a variety of therapeutic techniques, including medications. Medications are approved by the FDA for specific indications.
When we use these medications, we use them for their therapeutic effects, but virtually all medications have some side effects. When starting, or adjusting, the dose of medications we need to advise patients of the potential consequences, in terms of, side effects, reiterate the rationale for using the medication, and document this in the medical record so that it's clearly stated.
In addition, it is an essential part of medical practice to be able to use medications for illnesses or conditions other than those that are indicated by FDA approval. This is common practice in all areas of medicine. Indeed, sponsors (pharmaceutical companies) are not going to pursue indications for all of the purposes for which their products can be used.
Physicians, in using medications for non-indicated or off-label purposes, need to have an adequate justification for this, in terms of evidence in the literature that justifies the use, or at the very least, a scientific or medical rationale for the use of the medication. It is important to document this in the medical record, so that if there is a question about the purpose of the medication, or whether there was undue influence by a pharmaceutical company (as opposed to having a rationale, in terms of clinical practice evidence in the literature for efficacy, or a pharmacologic rationale for why the drug would be useful for a given patient), this can be reflected in the medical record.
It's unfortunate that we have to be so vigilant for potential assaults on our clinical practice and we have to practice defensive medicine, but such is the world that we live in, so it behooves us as physicians to protect ourselves by documenting our presentations to patients about the risks and benefits of treatment, and (if we are using the medication for a non-FDA indicated purpose, an off-label use of the medication) the rationale for this use.
This will enable you to think through the steps, in terms of prescribing a treatment, whether it's on-label or off-label, and at the same time, it will also serve as a protective practice, in terms of reducing legal liability. This routine, this set of procedures, can be made habitual and systematized. It's a little like the book by our colleagues, Atul Gwand, who wrote about the "checklist approach" to medicine as a way of reducing medical errors and trying to emulate the way that aeronautical engineers and pilots manage their procedures in a very routine, systematic way with a series of checklists.
Physicians can do the same when prescribing of treatments, and in this way, physicians can both ensure that they are thorough, as well as reduce their legal liability. Those are my comments for today -- this is Dr. Jeffrey Lieberman of Columbia University for Medscape.

 

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