Sometimes physicians are confronted with patients whose medical conditions do not respond well to the accepted standard dose of the medication relied upon to treat their condition.  When faced with this issue, a physician may be inclined to increase the patient’s dose of mediation beyond the accepted standard.  A physician may also consider an off-label prescription use to treat the patient’s condition.  Since these options may appear to be experimental in nature, a physician should take the proper steps to make sure their patient is fully informed of the potential side effects of the medication, and to make sure their patient is closely monitored for adverse side effects.  

Two psychiatrist were recently sued by three patients for prescribing medication to treat their patients depression which was in excess of the Physician’s Desk Reference standard dose.  One of the patients dismissed the case before trial.  The defendant physicians settled the case with regard to the other two plaintiffs during trial.

In 1991, the first patient was being treated for prolonged and recurrent depressions which were unresponsive to currently approved antidepressants or psychotherapy.  The patient also had a history of alcohol dependency and abuse.  She was unable to work or function for over a year when she first saw the defendant physician.  The physician started the patient on bupenorphine in 1991 at which time literature and research supported its use in the treatment of depression.  At that time the medication was known to produce only low level physical dependence and relatively minor withdrawal symptoms.  The patient’s depression improved rapidly while on the medication and she obtained a full-time job within a month of starting on bupenorphine and held it for over eighteen months.

The physician took steps to appropriately counsel the patient about the risks of dependency and minor withdrawal symptoms on bupenorphine versus the possibility of a recurrence of her depressive symptoms if she stopped taking bupenorphine.  In light of the patient’s severe depressive history and her failure to respond to other antidepressant medications, the physician continued the patient on bupenorphine. Subsequently, the patient signed herself into a psychiatric hospital, terminated her treatment with bupenorphine, and, regrettably, returned to her former depressed state.

            The second patient also suffered from depression and had a history of alcohol dependency and abuse.  The patient presented with a prior history of opiate use and responded to very low doses of buprenorphine with a remarkable decrease in depression.  The second physician believed that the patient’s history of mood elevation (normalization) with the use of opiates for pain constituted a favorable prognostic indicator that the patient's depression would respond favorably to buprenorphine.

            The physician provided the patient with information about the risk of dependency and withdrawal symptoms when taking the medication.  The patient was asked to balance these risks against the antidepressant effect of the medication and the possibility of a recurrence of depressive symptoms.  Throughout the patient’s treatment with buprenorphine, the physician endeavored to prescribe only low dosages of the medication.  For most of the course of treatment the patient's prescription did not exceed the starting doses for patients who receive the medication for pain relief and was always substantially less than the dosage used as an aid in withdrawing from heroin.  It was also only one-fourth of the level used in available clinical studies, which found either minimal or no withdrawal symptoms when the drug was stopped.

            The physician adjusted the dosage of the medication in response to the apparent tolerance developed by the patient to the antidepressant effects of the medication.  Until the last month of treatment, the physician’s care and treatment of the patient, including the administration of the medication, continued to result in positive changes in the patient's mood which allowed him to adequately function in his life, obtain employment, and gain the sought after relief from his depressed state.  However, after 14 months of apparently good response the patient's tolerance to the drug raised issues about the benefits of continuing its use.  The physician considered and counseled the patient concerning withdrawal from buprenorphine.  After consulting with another physician about the value of stopping the medication, the physician undertook efforts at gradual tapering of the dose.  However, efforts at outpatient dose reduction and withdrawal were unsuccessful. After the patient terminated his treatment with buprenorphine, he experienced some withdrawal symptoms which did not require medical intervention, but for which he sought acupuncture treatment. 

            The patients claimed that their treating physicians breached the standard of care by prescribing bupenorphine in a dose which was in excess of the Physician’s Desk Reference.  The patients also claimed that it was inappropriate to prescribe them bupenorphine in light of their history of alcohol abuse.  The patients claimed the physicians should have attempted to treat their depression with clinically approved anti-depressants.  In addition, the patients claimed that the physicians failed to fully inform them about the side effects of taking bupenorphine.     

            The defendant physicians retained an expert physician who was expected to testify that it was within the standard of care to continue to prescribe buprenorphine to a depressed patient, while developing a plan to help her discontinue its use.  Since the patients had a history of mood elevation with the use of opiates for pain, this constituted a favorable prognostic indicator that the patients’ depression would respond favorably to the medication.  It was also within the standard of care to prescribe buprenorphine to treat patients, who presented with refractory depression unresponsive to currently approved antidepressants despite a history of alcohol dependency and abuse.  The expert physician was also expected to testify that the standard of care did not require the physicians to first prescribe other antidepressant medications prior to continuing to prescribe buprenorphine, especially in light of the patients’ failure to respond to other antidepressants.

            The physician would have also testified that the physicians’ care and treatment of the patient, including the administration of the medication, continued to result in positive changes in the patient's mood which allowed the patient to adequately function in her life, obtain employment and gain the sought after relief from her depressed state. 

            Although the defendant physicians in this case had implemented a thoughtful plan to treat their patients’ symptoms of severe depression, they did not clearly document this thought process in the patients’ medical records.  In addition, although the physicians had discussed the side effects of the medication with their patients, these conversations were never fully memorialized in the records. This incomplete documentation made it somewhat difficult to defend the decision to treat the patients with high doses of medication. 

            In light of this case, physicians should clearly document their thought process when they decide to forgo conventional medical treatment.  A physician should document all the various modes of treatment that were initiated before the decision to use high levels of medication was made.  A physician should document all the possible side effects of increasing the dose of medication and develop a treatment plan which closely monitors for these symptoms.  Finally, a physician should fully document every conversation they have with a patient regarding the side effects of the medication and the risks and benefits of continuing to treat their condition with the medication.


Medication

by Attorney Frank E. Reardon

November 1999

Healthcare Law, Litigation & Public Policy   Medical Licensure & Discipline ♦ Employment Board of Registration

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