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MEDICOLEGAL CONSIDERATIONS IN THE TREATMENT OF MOOD AND ANXIETY DISORDERS
In the past decade, a large increase has been reported in the proportion of Americans who receive medication for depression. At least part of this growth in depression treatment and awareness has occurred because of the growing realization that depression is a common and serious illness. The World Health Organization (WHO) now ranks major depression as one of the most burdensome diseases in the world. In the same decade, selective serotonin reuptake inhibitors (SSRIs) have become one of the most commonly prescribed medications in the United States and worldwide.
Several medicolegal pitfalls may arise in the setting of treating patients with mood and anxiety disorders. The most serious one is the question of responsibility and negligence that arises when a patient commits suicide or acts of violence while under the care of a psychiatrist or other physician. Another key medicolegal issue is whether antidepressants (specifically, SSRIs) are causative in acts of suicide or violence and whether the physician properly warned the patient of this potential risk.
The standards of care in malpractice lawsuits vary by state but are mostly based on either customary average practice or reasonable practice. One of the many problems with this concept is that, with rapid advances in the medical field, standards of care can also change rapidly, thereby outdating benchmarks and requiring periodic review of current standards of care.
Malpractice litigation usually has the following 4 elements:
- Duty of the health care provider to provide reasonable care
- Negligence whereby the health care practitioner failed to provide reasonable care
- Damages that may have been incurred because of this negligence
- Causation (or direct causation or proximate cause) whereby the negligence directly causes the personal damage
To bring a claim, an injury must relate to an actual loss or damage. In cases that involve the treatment of a patient for mood or anxiety disorders, the claim is usually brought by the family of a patient who committed suicide or by another individual who has been the victim of violence perpetrated by a person with mental illness.
SUICIDE RISK ASSESSMENT
Patient suicide is the leading cause of malpractice lawsuits filed against psychiatrists. It also accounts for the highest percentage of settlements and verdicts covered by insurers. In developed countries, the annual rate of completed suicide is 15 per 100,000 persons. The risk of completed suicide is higher in persons with generalized anxiety disorders and mood disorders. This is especially true of patients with bipolar disorder, for whom the rate of completed suicide is 400-1,400 per 100,000 persons.
The American Psychiatric Association has released new guidelines for suicide risk assessment. The key steps to assessment include the following:
- Perform a thorough psychiatric evaluation, including screening for symptoms of hopelessness and agitation and a history of substance abuse.
- Determine the presence of psychiatric illness and prior history of suicide attempts.
- Identify psychosocial stressors.
- Specifically question the patient about suicide and homicide.
- Does the patient have a plan for suicide or homicide?
- Has the patient previously attempted suicide or homicide?
- Estimate the patient’s level of risk for suicide or homicide.
- Create a treatment plan that focuses on modifiable risk factors. Depression, anxiety, and insomnia must be treated aggressively. As is common practice when doctors prescribe narcotics, only one clinician should prescribe all the antidepressants for a particular patient. For actively suicidal patients, options include the following:
- Refer the patient to a psychiatrist.
- Hospitalize the patient.
- Contact the police, as suicide is against the law.
To guard against medicolegal action, appropriate and complete chart documentation may be as important as the actual assessment and treatment of the patient. Often, physicians provide appropriate care but may omit proper and complete medical documentation, use unaccepted abbreviations, or write illegibly. These factors all contribute to a poor medical chart and can lead to situations in which thoughtful and appropriate care for the patient cannot be demonstrated.
HOMICIDE AND VIOLENCE
Physicians can be held liable if they had or should have had some knowledge of a patient’s inclination to harm himself or others but did not take proper precautions. Physicians have a duty to protect a patient from himself or warn third parties if a patient makes threatening statements.
LIABILITY IN PRESCRIBING ANTIDEPRESSANTS
Multiple liability issues exist regarding the treatment of patients with depression and anxiety. A physician in any specialty who prescribes medications for or treats patients with these comorbidities may be at risk for liability. However, because of the absolute volume of patients seen and the fact that refractory cases may be referred to them, psychiatrists are at increased risk for such liability.
Disclosure of potential adverse effects
Negligence claims may arise not only from failure to recommend therapy but also from failure to warn patients of potential adverse effects of treatment. Proper disclosure is particularly important when adverse effects are potentially life-threatening. Listing all of the adverse effects of a certain medication is impossible and impractical. However, patients must be informed about the most serious adverse effects, especially those mandated by the US Food and Drug Administration (FDA) under a black box warning. These disclosures to patients must be properly documented.
Drug-to-drug interactions
Always check for life-threatening drug-to-drug interactions, and ask the patient to check with his or her pharmacist for any others. Some antidepressants may, by enzyme inhibition or augmentation, have the potential to cause numerous drug interactions.
Discontinuation reactions
Discontinuation reactions caused by sudden termination of antidepressant therapy can cause various symptoms, including gastrointestinal symptoms, insomnia, nightmares, low mood, anxiety, and irritability. Patients should be educated on the importance of not missing doses of their medications. If an antidepressant that has been prescribed for 8 weeks or longer is to be removed from a patient’s regimen, the dose should be gradually tapered over 4 weeks to lower the risk of discontinuation symptoms.
Overdose
In the case of older antidepressants called tricyclics, a very small overdose can be fatal. Even when the practitioner has warned the patient of the risk of overdose and prescribed only a limited quantity of the medication, instances of tablet-hoarding and subsequent suicide attempt have occurred. In such cases, the question of physician liability arises. A standard of care does not exist for suicide prediction, and, unfortunately, many patients who do commit suicide have denied suicide plans when questioned about them shortly before the act.
In Illinois, a 28-year-old woman committed suicide by overdosing on a prescription of doxepin, an older antidepressant. The woman’s family blamed the family doctor, who had filled a prescription for doxepin that was written by the woman’s psychiatrist. The main question addressed by the Supreme Court of Illinois in this case was whether a person with a mental illness could be held personally accountable for her own suicide.
Increased risk of suicide with treatment
Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients with manic depressive disorders and also in patients treated with SSRIs. Concern exists that these patients may be at increased risk for worsening depression or suicide.
The first SSRI wrongful death/suicide case to go to jury trial was in 1998 in Tobin v SmithKline Beecham Pharmaceuticals. Over the next 5 years, several similar lawsuits were filed that involved the role of several SSRIs in wrongful death. Finally, on March 22, 2004, the FDA asked manufacturers of antidepressant drugs to include in their labeling a warning statement that recommends close observation of adult and pediatric patients treated with these agents for worsening depression or the emergence of suicidality. The drugs that are the focus of this new warning are fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram (Lexapro), bupropion (Wellbutrin), venlafaxine (Effexor), nefazodone (Serzone), and mirtazapine (Remeron). Furthermore, the FDA recommended that any medication change should involve dose tapering rather than abrupt cessation.
Children and adolescents
Children are, presumably, not competent to make informed treatment decisions, even though data suggest that adolescents aged at least 14 years have the same reasoning abilities as adults. All discussions regarding treatment choices for minors should, therefore, be made in the presence of a parent or guardian. Except for fluoxetine, most SSRIs have not been found to be effective for treatment of depression in this age group. Also, none of the older antidepressants have been found to be effective for treatment of depression in this age group. In Europe, SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) are not authorized for treatment of depression and anxiety disorders in children and adolescents because of the increased risk of suicidal behavior (ie, suicidal thoughts and attempts).
REFERENCES
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Practice guidelines for the treatment of psychiatric disorders compendium. 2nd ed. Arlington,Va: American Psychiatric Association; 2004:835-1027.
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