Medicolegal Issues

How to monitor medication side effects

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References

Woman prescribed a stimulant suffers stroke and disability

Harris County (TX) District Court

A 39-year-old patient was diagnosed with attention-deficit/hyperactivity disorder (ADHD) by a psychologist, who referred her to a psychiatrist. The psychiatrist prescribed amphetamine/dextroamphetamine, which the patient took for 9 months. During this time her blood pressure and other vital signs were not monitored. The patient then suffered a stroke, is now a paraplegic, and must use a wheelchair.

The patient claimed that negligent misdiagnosis and monitoring caused the stroke. The psychiatrist maintained that diagnosis and monitoring were appropriate, and the drug did not cause the stroke. The psychiatrist also claimed that the patient had a transient ischemic attack (TIA) before taking amphetamine/dextroamphetamine and another stroke after discontinuing the drug.

  • A defense verdict was returned

Improper dose of lamotrigine blamed for liver failure

San Diego County (CA) Superior Court

The patient, age 35, was involuntarily admitted to an inpatient psychiatric facility after the police found her acting bizarrely and hallucinating. The admitting and treating psychiatrist learned that the patient had been admitted for psychiatric treatment 9 times in the previous 12 months, had a long history of polysubstance abuse, and had been largely nonadherent with medication. The psychiatrist diagnosed rapid-cycling bipolar disorder and started the patient on lamotrigine with an escalating dosage schedule. The patient was released from the psychiatric facility.

Later that month, the patient developed a urinary tract infection and was readmitted to the hospital. She agreed to lab testing and all results were within normal limits, but throughout a 2-month stay the patient intermittently complained of a sore throat, cough, and nausea. Two weeks later, the psychiatrist reviewed lab tests that showed a mild elevation of the patient’s liver enzymes.

The next day the patient reported a rash on her chest and a high fever. She was transferred to an acute care facility. The patient’s liver enzymes continued to rise, and the psychiatrist discontinued lamotrigine. The patient continued to deteriorate and was transferred to another hospital to consult with a liver specialist. About 3 weeks later the patient went into a coma and died.

Autopsy showed massive liver necrosis. The patient’s family claimed the psychiatrist was negligent in giving the patient lamotrigine, which caused the liver failure. They contended the dose prescribed was too high, the patient was not properly monitored, and other psychiatric drugs could have been used with more gradual increases.

The psychiatrist maintained that the lamotrigine dosage used was appropriate, lamotrigine was not known to cause liver problems, and it did not cause the patient’s liver failure.

  • A defense verdict was returned

Dr. Grant’s observations

These cases reflect a clinician’s worst nightmare—using an appropriate medication, experiencing a disastrous outcome, and then being sued for malpractice. Clinicians need to remember:

  • anyone can be sued
  • a lawsuit does not mean that the clinician did anything inappropriate.
It is unfortunate that such lawsuits are brought, and their presence may indicate many problems within the legal system. Although clinicians who do nothing wrong should not have to endure unnecessary and unfounded lawsuits (the issue of tort reform within the legal system is beyond the scope of this column), these cases prompt psychiatrists to consider ways to protect themselves from such claims. Some practices might help protect you from successful malpractice claims, but there are no guarantees.

Meeting standards of care

Medical malpractice claims could be based on a physician diverging from 1 of 2 standards of care:

  • The “average practitioner” or “customary practice” standard means the treatment practice is consistent with others in the field. Courts might allow the medical profession to define the standard of care according to medical custom.
  • The “reasonably prudent physician” standard means what a reasonable physician would have done under the circumstances. The jury determines if the physician acted reasonably, not whether the physician conformed to existing standards.1
States are split on which standard the courts must apply and in many areas, the standard of care is based on local—not state or national—practices.2

In these cases, using amphetamine/ dextroamphetamine for ADHD and lamotrigine for bipolar disorder appears to meet either standard. These 2 drugs are FDA-approved to treat the disorders for which they were prescribed. Although we do not know what doses the physicians prescribed in these 2 cases, in general if the dosing adheres to the FDA-approved range or can be based on credible research, the treatment will meet the 2 standards.

Choosing a treatment plan

The American Psychiatric Association’s practice guidelines (available at http://www.psych.org/psych_pract/treatg/pg/prac_guide.cfm) state “the ultimate judgment regarding a particular clinical procedure or treatment plan must be made by the psychiatrist in light of the clinical data presented by the patient and the diagnostic and treatment options available.”3

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