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Several significant factors have converged to impact and heighten concern about the potential for malpractice litigation related to psychopharmacology. Current influences as well as frequent sources of professional liability risk related to psychopharmacology are reviewed and suggestions for preventing and reducing risk are made.
Four significant issues have converged to impact and heighten concern aboutthe potential for more malpractice litigation related to psychopharmacology:
This article will review sources of professional liability risk related topsychopharmacology and make some suggestions for preventing and reducing risk.
Advances in psychopharmacology have provided therapeutic options that wereunavailable just a short time ago. This has resulted in an increase in the useof psychotropic medications in all age groups. The efficacy and safety ofpsychotropic medications, especially in pediatric patients, is an ongoing issuein clinical practice and psychopharmacologicalresearch (Curtis et al., 2005). Specific concern about the off-label use ofpsychotropic 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 theMarch 22, 2004, Public Health Advisory from the U.S. Food and DrugAdministration about worsening depression and suicidalityin patients treated with antidepressants and with the FDA's directive for ablack box warning about this risk on the package labeling of antidepressants(FDA, 2004). Moreover, research findings and reports in the media about variousserious side effects and risks of psychotropic medications often emphasize theproblems and not the benefits of these drugs. Announcements such as the FDAPublic Health Advisory of April 11 (FDA, 2005) regarding increased mortality inelderly 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 the1999 Institute of Medicine report "To ErrIs Human: Building a Safer Health System" (Kohn et al., 2000), point to theprevalence of adverse medication events in causing patient injuries. In a 2002study, Rothschild and colleagues found that "[a]dversedrug events associated with malpractice claims were often severe, costly, andpreventable." Prevention of ADEs is one of fourpriority areas approved by the American Psychiatric Association Board ofTrustees for patient safety activities to be directed in psychiatric practice(APA, 2002). Increased awareness of the problem at the early stages of thepatient safety movement may prompt more attention to ADEswith a subsequent impact on litigation. However, in the longer-term, patientsafety initiatives hold the promise of decreasing ADEsand related malpractice actions. (See Liang for a discussion on the impact of tort and contract law on patient safetyefforts.)
High-profile legal actions against physicians related to prescribingscheduled controlled substances periodically causeconcern for physicians about professional liability risk and even criminal riskin this heavily regulated area of practice. Historically, innovations inmedicine have often been followed by an increase in medical malpracticelawsuits. These innovations usually add to the complexity of treatment and maysimultaneously increase patients' unrealistic expectations for positive treatmentoutcomes (Sage, 2003). Against this background, psychiatrists' prescribingdecisions will be scrutinized more than ever, increasing the risk ofprofessional liability.
Sources of Liability
Medical malpractice actions involving psychopharmacology usually allegenegligence in prescribing, administering and monitoring medication(s), and/orfailure to obtain informed consent or adequate informed consent (Table 1).
Prescribing.Allegations about negligent prescribing encompass the adequacy of assessment/evaluationof the patient (including history-taking, physical findings, obtaining pasttreatment history/records), diagnostic formulations and the decisions regardingmedication(s) (including which to prescribe, dosage, frequencyof dose and management of refills) (Table1).
Off-label prescribing is a widespread and well-accepted part of medicalpractice and is not, in and of itself, a professional liability risk. Off-labeluses range from the clearly controversial to those considered the establishedstandard of care. Typical off-label uses include prescribing for a conditionnot indicated on the FDA-approved labeling, prescribing at a different dosagethan indicated or a different patient population.
Physicians are entitled to prescribe FDA-approved medications for off-labeluse (Arbitblit and Fleishman, 2005; FDA, 1982; O'Reillyand Dalal, 2003). The American Medical Association(AMA, 2004) (emphasis added)
confirms its strong support for the autonomous clinical decisionmaking authority of a physician andthat 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 associatedwith off-label prescribing are: 1) whether the decision to prescribe off-labelis evidence-based; and 2) whether supporting documentation reflect thepsychiatrist's clinical judgment and decision making for prescribing this drugin this instance for this patient. Should a lawsuit arise with allegations thatthe off-label use injured a patient, these two elements provide evidence thatwill help defend the case.
Despite some recent high-profile media reports, criminal prosecution ofphysicians based on allegations of prescribing controlled substances for otherthan legitimate purposes is rare. Becoming the subject of a malpractice lawsuitand/or administrative (i.e., medical licensure) action alleging inappropriateprescribing is the greater risk. Examples of cases involving scheduledcontrolled substances include: 1) a patient death with allegations that theamount of methadone (Dolophine, Methadose)prescribed caused methadone toxicity and; 2) a patient death with allegationsthat methadone was prescribed for narcotic addiction treatment outside aspecialized opioid treatment program in violation offederal and state law. Sometimes these cases are brought with allegations thatthe patient became addicted to the controlled substance due to the physician'sprescribing practices.
All aspects of prescribing and dispensing controlled substances are highlyregulated. Knowledge of and compliance with the federal, state and local lawsand regulations, and applicable state medical board guidelines and position statementsabout prescribing scheduled controlled substances, along with utilizing thestandard medication safety practices used for prescribing any drug, arecritical to avoiding professional liability risk when prescribing scheduledcontrolled substances. (For more information and resources, see Federation ofState Medical Boards [2005, 2002]).
Administering.Lawsuits alleging negligent administration of medications are not often seenagainst psychiatrists. Allegations usually involve ordering and/or administeringa medication by the wrong route (e.g., giving the drug intravenously instead ofintramuscularly). Such problems are more likely to occur in crisis or emergencypractice settings and often involve possible negligence of the nursing staff orother hospital staff in the administration of the drug ordered by thepsychiatrist.
Monitoring.Liability claims based on alleged failure to properly monitor a prescribedmedication may be particularly difficult to defend because of well-establishedstandards and guidelines for the monitoring of many psychotropic medications(e.g., clozapine [Clozaril],lithium [Eskalith, Lithobid],antidepressants). Furthermore, ongoing monitoring of drug treatment is a basictenet of medical treatment. Any failure to monitor will be characterized by aplaintiff's attorney as a virtual abandonment of the patient's care. It isrecommended that psychiatrists set up a system for regularly monitoringmedications prescribed as well as documenting the results of monitoring (Table 2).
Some of the most serious cases involving negligence in monitoringpsychotropic drugs are those in which patients develop tardivedyskinesia or neurolepticmalignant syndrome. These cases also typically include allegations of lack ofinformed consent or inadequate informed consent.
Informed consent.Informed consent allegations are prevalent in medication-based malpracticeclaims. Physicians have a duty to disclose to patients the informationnecessary for them to make informed decisions about treatment recommendations,including psychotropic medications. The specific legal standard regarding aphysician's duty to disclose information varies from state to state. Regardlessof a jurisdiction's disclosure standard, the law of informed consent requiresthat the basic content of the disclosure include (Rozovsky,2004):
In certain lawsuits involving psychopharmacology, both the psychiatrist andthe drug manufacturer are sued by the patient/plaintiff. In some of these casesthe intended target is the drug company and the defendant doctor issubsequently dismissed from the litigation. When the case proceeds againstboth, the drug company may rely on the "learned intermediary doctrine" in anattempt to place liability on the physician (O'Reilly and Dalal,2003). The learned intermediary doctrine operates to shield the drugmanufacturer from liability if the company proves that adequate information andwarnings about the drug were available to the prescribing physician. Theprescribing doctor, the "learned intermediary," then has the duty to disclosethe information about the medication so the patient may make an informeddecision about the risks and benefits of drug treatment (O'Reilly and Dalal, 2003).
Other, less common sources or theories of liability related to psychotropicmedications are beyond the scope of this article. Regardless of the theory ofliability that is alleged, the determination of whether medical malpracticeoccurred requires an analysis of the applicable standard of care.
Standard of care.A plaintiff must establish that a physician's actions or omissions were adeparture from the accepted standard of care in order to prove a claim ofnegligence. A physician who deviates from the standard of care has the burdenof proving that there was a justification for that deviation. Although there isvariation among jurisdictions, generally, the standard of care is the degree ofskill, care and diligence exercised by other physicians practicing in similarsituations and in light of the present state of medical science. This is a "reasonableness"standard.
The standard of care is established primarily by psychiatrists in the roleof the expert witness. In providing an opinion about the applicable standard ofcare, the expert witnesses for the plaintiff and for the defense will rely ontheir own clinical experience, education and the clinical record, as well as avariety of legal and professional standards and resources that are indicativeof and can be used as evidence to establish the applicable standard of care ina given case (Table 3).
Key risk management strategies for reducing professional liability riskrelated to psychopharmacology include:
As one researcher stated, "Psychiatric care relies heavilyon medications, which are relatively toxic, although highly beneficial overall"(Bates et al., 2003). Many lawsuits against psychiatrists includeallegations involving medications. It is imperative that psychiatrists engagein thoughtful decision making with regard to prescribing, communicateeffectively with patients about medications, and be cognizant of the probable sourcesof liability and the factors involved in a standard-of-care analysis.
The author gratefully acknowledges theassistance of Donna L. Vanderpool, J.D., M.B.A., inlocating reference materials for this article.
Ms. Melonas is vice president of risk management at Professional Risk Management Services, Inc. She is also a health care attorney and a clinical specialist in psychiatric nursing with a focus on child and adolescent psychiatry.
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