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Preventing and Reducing Professional Liability Risk Related to Psychopharmacology

Preventing and Reducing Professional Liability Risk Related to Psychopharmacology

Four significant issues have converged to impact and heighten concern about
the potential for more malpractice litigation related to psychopharmacology:

  • Psychiatric malpractice lawsuits frequently include allegations of negligence related to the use of psychotropic medications because these drugs are vital to the treatment of mental disorders.
  • A host of controversies about the safety of psychotropic medications has been widely publicized, debated and considered in various realms (e.g., regulatory, research, clinical, drug industry, medical
    profession, patient advocacy).
  • Adverse drug events (ADEs) are a focus of attention by the patient safety movement in an effort to
    decrease medical errors.
  • Historically, advances in medical treatment tend to increase medical malpractice litigation.

This article will review sources of professional liability risk related to
psychopharmacology and make some suggestions for preventing and reducing risk.


Advances in psychopharmacology have provided therapeutic options that were
unavailable just a short time ago. This has resulted in an increase in the use
of psychotropic medications in all age groups. The efficacy and safety of
psychotropic medications, especially in pediatric patients, is an ongoing issue
in clinical practice and psychopharmacological
research (Curtis et al., 2005). Specific concern about the off-label use of
psychotropic medications has been voiced by consumers and, in some instances,
by experts.

These issues have received more attention lately. This is due in part to the
March 22, 2004, Public Health Advisory from the U.S. Food and Drug
Administration about worsening depression and suicidality
in patients treated with antidepressants and with the FDA's directive for a
black box warning about this risk on the package labeling of antidepressants
(FDA, 2004). Moreover, research findings and reports in the media about various
serious side effects and risks of psychotropic medications often emphasize the
problems and not the benefits of these drugs. Announcements such as the FDA
Public Health Advisory of April 11 (FDA, 2005) regarding increased mortality in
elderly patients with behavioral disturbances prescribed atypical antipsychotics have added to the escalating national debate about post-approval safety of prescription medications.

Patient safety research and initiatives, in large part stimulated by the
1999 Institute of Medicine report "To Err
Is Human: Building a Safer Health System" (Kohn et al., 2000), point to the
prevalence of adverse medication events in causing patient injuries. In a 2002
study, Rothschild and colleagues found that "[a]dverse
drug events associated with malpractice claims were often severe, costly, and
preventable." Prevention of ADEs is one of four
priority areas approved by the American Psychiatric Association Board of
Trustees for patient safety activities to be directed in psychiatric practice
(APA, 2002). Increased awareness of the problem at the early stages of the
patient safety movement may prompt more attention to ADEs
with a subsequent impact on litigation. However, in the longer-term, patient
safety initiatives hold the promise of decreasing ADEs
and related malpractice actions. (See Liang
[1999] for a discussion on the impact of tort and contract law on patient safety

High-profile legal actions against physicians related to prescribing
scheduled controlled substances periodically cause
concern for physicians about professional liability risk and even criminal risk
in this heavily regulated area of practice. Historically, innovations in
medicine have often been followed by an increase in medical malpractice
lawsuits. These innovations usually add to the complexity of treatment and may
simultaneously increase patients' unrealistic expectations for positive treatment
outcomes (Sage, 2003). Against this background, psychiatrists' prescribing
decisions will be scrutinized more than ever, increasing the risk of
professional liability.

Sources of Liability

Medical malpractice actions involving psychopharmacology usually allege
negligence in prescribing, administering and monitoring medication(s), and/or
failure to obtain informed consent or adequate informed consent (Table 1).

Allegations about negligent prescribing encompass the adequacy of assessment/evaluation
of the patient (including history-taking, physical findings, obtaining past
treatment history/records), diagnostic formulations and the decisions regarding
medication(s) (including which to prescribe, dosage, frequency
of dose and management of refills) (Table

Off-label prescribing is a widespread and well-accepted part of medical
practice and is not, in and of itself, a professional liability risk. Off-label
uses range from the clearly controversial to those considered the established
standard of care. Typical off-label uses include prescribing for a condition
not indicated on the FDA-approved labeling, prescribing at a different dosage
than indicated or a different patient population.

Physicians are entitled to prescribe FDA-approved medications for off-label
use (Arbitblit and Fleishman, 2005; FDA, 1982; O'Reilly
and Dalal, 2003). The American Medical Association
(AMA, 2004) (emphasis added)

confirms its strong support for the autonomous clinical decisionmaking authority of a physician and
that a physician may lawfully use an FDA approved drug product or medical device for an unlabeled indication when such use is based upon sound scientific evidence and sound medical opinion.

Critical issues in the evaluation of professional liability risk associated
with off-label prescribing are: 1) whether the decision to prescribe off-label
is evidence-based; and 2) whether supporting documentation reflect the
psychiatrist's clinical judgment and decision making for prescribing this drug
in this instance for this patient. Should a lawsuit arise with allegations that
the off-label use injured a patient, these two elements provide evidence that
will help defend the case.

Despite some recent high-profile media reports, criminal prosecution of
physicians based on allegations of prescribing controlled substances for other
than legitimate purposes is rare. Becoming the subject of a malpractice lawsuit
and/or administrative (i.e., medical licensure) action alleging inappropriate
prescribing is the greater risk. Examples of cases involving scheduled
controlled substances include: 1) a patient death with allegations that the
amount of methadone (Dolophine, Methadose)
prescribed caused methadone toxicity and; 2) a patient death with allegations
that methadone was prescribed for narcotic addiction treatment outside a
specialized opioid treatment program in violation of
federal and state law. Sometimes these cases are brought with allegations that
the patient became addicted to the controlled substance due to the physician's
prescribing practices.

All aspects of prescribing and dispensing controlled substances are highly
regulated. Knowledge of and compliance with the federal, state and local laws
and regulations, and applicable state medical board guidelines and position statements
about prescribing scheduled controlled substances, along with utilizing the
standard medication safety practices used for prescribing any drug, are
critical to avoiding professional liability risk when prescribing scheduled
controlled substances. (For more information and resources, see Federation of
State Medical Boards [2005, 2002]).


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