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Ethical and Legal Dimensions of Benzodiazepine Prescription

by Harold J. Bursztajn, M.D. and Archie Brodsky, B.A.

From the Department of Psychiatry, Harvard Medical School, Boston, Massachusetts. Dr. Bursztajn is Associate Clinical Professor of Psychiatry and Co-director of the Program in Psychiatry and the Law, Harvard Medical School at Massachusetts Mental Health Center. Mr. Brodsky is Senior Research Associate in the Program in Psychiatry and the Law. Please address reprint requests to Dr. Bursztajn at the address below.

February 16, 1997

Corresponding author:
Harold J. Bursztajn, M.D.
harold_bursztajn@hms.harvard.edu

The use of benzodiazepines presents a unique set of clinical, ethical, and legal dilemmas.  Benzodiazepines are invaluable therapeutic agents which (in varying degrees) may produce physiological dependence; moreover, their use may complicate or be complicated by the abuse of other substances.  In prescribing these controlled substances, more than with other medications, physicians may be perceived to be acting as agents of the state as well as of the patient, with the potential for ethical conflict that this dual role entails.

In some circumstances it may be unethical to prescribe benzodiazepines; in other circumstances it may be unethical to withhold them, even if prescribing involves risks for the clinician.  Benzodiazepines suffer from guilt by association, in that the clinician who treats street-drug users will often see benzodiazepines used to self-medicate the consequences of that abuse.  On the other hand, the clinician who treats a more heterogeneous population may see Valium (diazepam) misuse, but will not see true addiction, insofar as there is no dose escalation or compulsive use in spite of adverse consequences.  As with insulin and digitalis, drugs needed for long-term therapeutic use may produce dependence, but that is not the same as addiction.  The closest that benzodiazepine abuse comes to addiction is as part of a pattern of poly-drug abuse, sometimes with the rationalization that other chemical addictions require, in compensation, increasing dosages of benzodiazepines.

Long-term therapeutic use of benzodiazepines occurs primarily in three groups of patients.  The largest group is those with chronic, serious medical illnesses (e.g., cardiovascular).  It would be cruel to deny to these patients, often well advanced in age, the degree of relief offered by benzodiazepines.  The second group is those with panic disorder.  Whether benzodiazepines are more appropriate for such individuals than SSRIs or other antidepressants must be decided by weighing therapeutic versus side effects on a case-by-case basis.  However, there is no evidence of benzodiazepine abuse in this population, and chronic use tends to result in gradual dose reduction over time.  The third group consists of individuals with chronic psychiatric disorders or repeated instances of acute stress.  Here, too, except for those with personality disorders, much chronic benzodiazepine use and pharmacological dependence occur in the context of legitimate treatment.

Typical Dilemmas

Disagreements between clinicians concerned mainly with overuse of benzodiazepines and those who focus on underuse are based in part on different perspectives, patient populations, and values.  Unfortunately, the salient dimensions of what should be a clinical controversy have all too often been obscured by the misuse of the term "addiction," which has created a false analogy between benzodiazepine dependence and addiction to substances of abuse.  This analogy, in turn, has brought with it irrelevant associations with antisocial behavior. [1]

Controversies over benzodiazepine use also reflect a larger debate concerning the physician's proper role in the treatment of substance abuse, a debate carried on historically between two major schools of psychiatry. [2]  The objective-descriptive school, founded a century ago by Emil Kraeplin and represented today by the DSM-IV, [3] values a relatively paternalistic approach to treatment.  By contrast, the "respectable minority" of psychoanalytically oriented therapists, whose practice has evolved from Freud's, emphasizes the importance of enhancing patient autonomy and authenticity. [4]  This schism within psychiatry mirrors the current debate in the substance abuse field, where client-centered approaches such as "motivational interviewing" [5] have arisen to challenge the paternalism of the "disease model."

As well summarized by Salzman, [6] the controversies surrounding benzodiazepine use are centered on three areas: (1) the potential for abuse, especially in the aftermath of therapeutic use; (2) the appropriateness of long-term use, in view of the risk of developing dependence and withdrawal symptoms; and (3) side effects, primarily cognitive impairment.  These controversies have generated sufficient concern that the American Psychiatric Association issued a task force report on the subject. [7]  This report and other recent sources [8] provide guidelines for prescribing in various clinical contexts, with indications and contraindications for different patient populations.  While such guidelines are useful as checklists for administrative purposes or as reminders for chart review, they are no substitute for the careful review and analysis of risks and benefits on a case-by-case basis which is the hallmark of psychopharmacological decision making. [9,10] Sound clinical practice, supported by forensic psychiatric consultation when necessary, will carry one through most difficulties. [11,12,13]

Pitfalls for the Physician

Ethical and legal dilemmas begin as clinical dilemmas, sometimes exacerbated by the constraints of managed health care.  Special care needs to be taken, therefore, when evaluating and treating a variety of vulnerable populations, including the pregnant patient, [14] institutionalized populations, such as geriatric residents of nursing homes [15] and inmates in correctional settings, people who live alone or who have a history of abuse or a disordered family situation, patients being treated with methadone, [16] and patients who are facing stresses such as examinations or testifying in court. [17]  Given that many alcohol and drug abusers also abuse benzodiazepines, a careful psychiatric examination, substance-abuse screening, and the recognition of biopsychosocial signs of abuse are imperative.  All of the above is easier said than done, given the increasing time pressures and devaluation of time spent with patients on the part of many managed-care reimbursement schemes.

Careful consideration is likewise needed when performing forensic psychiatric evaluations, such as employment evaluations, including applications of the Americans with Disabilities Act (ADA), [18] and mental-state evaluations in criminal cases, where the question of diminished capacity resulting from benzodiazepine use or dependency may arise in the determination of competency to stand trial, in the determination of criminal responsibility at trial, or as a mitigating factor in sentencing. [19]  Generally, it is best to separate the roles of the treating clinician and forensic evaluator to avoid complex issues of dual agency. [20]

The Managed-Care Context
Both the clinical and medicolegal risks of benzodiazepine prescription are reduced by an ongoing therapeutic alliance, the best foundation for high-quality care.  By getting to know the patient over a period of time, the physician can prescribe with a deeper understanding and greater confidence that the patient will work out any resulting problems within rather than outside the alliance.  Managed health care, by putting a premium on short hospital stays, short-term therapies, and the fifteen-minute psychopharmacological or internist patient visit, often precludes long-term alliance building.  Physicians feel compelled not only to prescribe benzodiazepines without adequate knowledge of the patient, but even to use these drugs as substitutes for listening to and talking with patients.

Under these conditions, it is sometimes appropriate to build an alliance around the physician's role of advocating for the patient's health-care needs.  On the other hand, this strategy may risk increasing dependency on a therapist who begins to be seen as an omnipotent advocate.  In such cases physicians may do better to work with patients so that they can advocate for themselves.  At the same time, in their zeal to avoid feeling scapegoated, physicians should not fall into the trap of scapegoating third parties.  Instead, they should work with insurers and managed-care organizations (MCOs) to create cost-effective treatments that meet the applicable standards of care. [21,22]

Civil Actions
Controversies concerning the appropriate prescription of benzodiazepines and clinical treatment of benzodiazepine-addicted patients sometimes resolve themselves in malpractice litigation.  Such litigation may result from the failure to take proper care when monitoring patients with known histories of substance abuse or from the failure to hospitalize such patients when appropriate as a precaution against withdrawal symptoms.  Grounds on which clinicians have been sued for malpractice involving benzodiazepine use include improper diagnosis, prescription drug interactions, cross-dependence with alcohol, failure to take appropriate measures to avoid increased drug or alcohol dependence, failure to obtain informed consent to the development of dependency on benzodiazepines, and failure to recognize benzodiazepine withdrawal.  A quick search reveals numerous instances of such civil actions in recent years.  Given the risk of accidental death from overdose, sometimes in combination with other drugs,16 or suicide in the treatment of substance-abusing or substance-dependent patients, monitoring for suicidal ideation in the context of a carefully considered and formulated treatment plan is crucial for avoiding both tragic outcomes and malpractice litigation.

Duty to third parties.  A common conundrum for physicians prescribing benzodiazepines is the concern that either their proper use or misuse will lead to harm to third parties.   Although this question is of greatest concern with those (such as airline pilots) who are entrusted with the safety of others, litigation is more often precipitated by driving mishaps. [23]  In a Canadian sample of drivers and pedestrians killed in accidents, nearly ten per cent had psychoactive substances (other than alcohol) in their blood, most often diazepam. [24] 

Petch [25] advises that "any drug likely to impair driving performance should be tried by the patient for a week without driving," and that, more pointedly, "Failure to inform patients of the risks of driving while on medication may lead to a claim of negligence against the prescribing doctor" (p. 614).  In fact, increased risk of driving error occurs mainly after the initial doses of benzodiazepines.  Chronic users at therapeutic doses are generally not at increased risk.  Indeed, when panic and anxiety are successfully treated, diminished distraction may result in improved driving skills.

Negligent supervision. A psychiatrist who prescribes benzodiazepines (or any psychotropic medications) to patients seeing other clinicians for psychotherapy or substance abuse counseling must keep in mind the doctrine of respondeat superior (also called vicarious liability), by which supervisors are held liable for harms suffered by their supervisees' patients. [26]  Irrespective of contractual arrangements or actual lines of authority, a physician will often be perceived as more than a mere prescriber of medication, but rather as overall manager of the treatment plan.  Physicians who treat patients receiving substance abuse counseling should be alert for any harmful effects on patients that may result from unresolved philosophical differences between the two disciplines.  They should likewise be alert to the relatively high risk of boundary violations (including sexual abuse of patients) in front-line clinical settings staffed by inexperienced counselors. [27] 

A physician who serves as the psychopharmacology backup may be at particular risk in such situations, even though the psychopharmacologist's actual supervisory responsibility may be minimal.  At the same time, the mere assertion of respondeat superior does not guarantee that a plaintiff's claim will be sustained in court.  As Anderson and Bursztajn [28] note, "forensic psychiatric expertise can help distinguish real from spurious claims based on the doctrine of respondeat superior by examining closely the particular contexts in which supervisory responsibility is exercised" (p. 46).

Sexual abuse: false memory.  The effects of diazepam appear on occasion to contribute to false allegations of sexual abuse by psychotherapists.  The mechanism by which this phenomenon occurs is unclear, although the tendency for high doses of benzodiazepines to cause acute anterograde amnesia7 may be suspected, as may their potential to disinhibit otherwise suppressed thoughts, wishes, and behavior.  Normal therapeutic doses taken regularly tend not to interfere with recall, except in patients with specific vulnerabilities, such as some elderly, some chronic trauma victims, and those with fragile boundaries between fantasy and reality.

In general, accusations against therapists made by drug-dependent patients need to be carefully evaluated.  Patients' perceptions may be distorted and the clarity and reliability of their memories compromised [29,30,31] by virtue of both their suffering and the medications they are taking.  A drug that helps a person forget a traumatic event may subsequently create a temptation to confabulate to fill the gap in memory.  On the other hand, an anxious person may remember less accurately than one whose anxiety is appropriately treated with benzodiazepines.

Patients also need to be specifically informed of the occasional risk of inhibition of orgasm and of sexual function generally with benzodiazepine use. [32,33]  Otherwise, there is a risk of increasing anxiety iatrogenically in vulnerable patients experiencing side effects in their area of vulnerability.

Administrative Sanctions
Allegations of abuse in the prescription of benzodiazepines are increasingly directed to medical licensing boards.  Allegation of a persistent pattern of improper prescription may result in license suspension or even revocation, which may in turn be appealed in state court.  There is a spectrum of allegations to licensing boards, ranging from claims involving "drug mills" that endanger patients to infractions of state laws which prohibit physicians from prescribing controlled substances for themselves or their family members.

Administrative regulation can also become counterproductive.  In particular, the triplicate prescription forms that a number of states require may well have reduced the appropriate therapeutic utilization of benzodiazepines, with questionable impact on overall drug abuse rates.  As a result, patients suffering from severe anxiety either have gone untreated or have been prescribed less safe, less effective medications such as barbiturates.1  Initiatives to replace triplicate prescription with an electronic data transfer system should be evaluated carefully for their potential impact on prescribing practice and confidentiality.

Criminal Prosecution
Prosecution of physicians for improper prescription of benzodiazepines further escalates the confusion of legitimate professional regulation with drug abuse control.  It involves the law in the dynamics of the patient-physician relationship, and it can draw the physician into the patient's negotiations with the law.  Patients who have a history of criminal behavior, especially illicit drug use (including benzodiazepines), may seek, as part of their plea bargains, to incriminate the treating physician.  This expedient blame-shifting can precipitate well-intentioned but at times tragically misguided criminal investigations by prosecutors taken in by the specter of a physician dangerously prescribing psychoactive medications, allegedly for no medical purpose. [34]  In the absence of precautionary consultation, the most conscientious clinician can face criminal charges after being taken in by drug enforcement agents posing as patients.

A troubling aspect of such "sting" operations is that the very anxiety felt by the agents over their undercover role may lend credibility to their request for benzodiazepines.  The misleading appearance of Generalized Anxiety Disorder can lead the unwary clinician, eager to alleviate the patient's apparent anxiety, to engage in what appears to be criminal misconduct.  Although an entrapment defense can be raised under such circumstances, such defenses are difficult in the face of juries already wary of the medical profession, given the increasingly impersonal nature of medical practice under today's cost-containment pressures.

The manner in which prosecutors' suspicions are aroused also bears examination.  When prosecutors make deals with criminals so as to bring charges against physicians, they are listening to individuals who may be taking a variety of drugs, which leaves them open to distortions of memory and confabulation. [35]  With such unreliable witnesses, intrapsychic and interpersonal dynamics produce a web of uncertainty.  Cases have often hinged on the testimony of witnesses with severe personality disorders, in whom forensic psychiatric evaluation might have shown severe impairment in neurophysiological and/or interpersonal capacities. [35]

The compulsions to which an addicted person is susceptible [36] may include compulsive lying.  This lying is not necessarily for the purpose of self-absolution, but may even be directed toward self-incrimination (and incriminating others, such as the physician) or concealment of major psychiatric illness that would otherwise be mitigating. [37]  That does not mean that everything the person says is to be discounted; to assume that a person is a liar by virtue of having an addiction would be discriminatory and untrue.  But it argues for a thorough case-by-case evaluation.

The differential treatment of benzodiazepines and noncontrolled substances such as Prozac (fluoxetine) can be seen in the resolution of disputes concerning their alleged misuse.  Disputes involving Prozac tend to be administrative and relatively easily settled, [38] whereas allegations of misuse of benzodiazepines usually result in imposition of criminal sanctions.  To criminalize benzodiazepine prescription is to ignore the social, psychological, and moral context -- a context of intention and meaning -- that defines what is or is not a crime.  A person dependent on benzodiazepines is very different from a person addicted to crack cocaine.  Likewise, even a misguided physician should not be treated as an antisocial drug dealer when the mens rea (intent) is not the same.

The current tendency to criminalize clinical, ethical, and civil disputes, as with patient-therapist sex [39] or physician-assisted suicide, [40] blurs essential distinctions.  Indeed, polarizing these issues as laissez-faire legalization versus criminalization reflects an institutional and societal inability to tolerate ambiguity.  The anxiety and rigidity characteristic of such polarized stances are picked up by clinicians, who become less able to make the wise decisions that can result from acknowledging and sharing uncertainty with patients. [41]  By contrast, the kind of regulation that fosters accountability is regulation that respects responsible autonomy.  Such regulation emphasizes education through ethically and clinically informed dialogue and encourages alternative dispute resolution, with civil litigation as a last resort.

Principles of Risk Management

Treacherous as they may be, the ethical and legal pitfalls of benzodiazepine prescription are best avoided or surmounted through sound clinical practice informed by ethical and legal understanding.  Some cardinal principles of such practice which can usefully be applied to treatment involving benzodiazepines are as follows:

Use informed consent as an alliance-building process.  Patients taking (or considering) benzodiazepines should be informed of the potential for physical dependence and the possibility of mild to moderate rebound with gradual tapering.  In the absence of this preparation, a patient may misinterpret withdrawal symptomatology as a sign of addiction and develop a pseudo-addiction.  At the same time, informed consent means more than just conveying these necessary specifics.  Pro forma informed consent -- i.e., the mere signing of a consent form after checking off a list of items -- is of no clinical value and of dubious legal value.  At best, it engages only the patient's cognitive, not affective capacities.  Moreover, among the three legally stipulated components of informed consent, a signed consent form provides evidence only of information, not of voluntariness or competence.  By contrast, when informed consent is carried out as a process or dialogue, the clinician shares the uncertainty of the clinical situation with the patient, so that the patient can share the responsibility for making wise decisions in spite of that uncertainty. [42]

In the course of this exchange, the clinician can assess the patient's competence to give informed consent at the affective as well as cognitive level, [43] with the understanding that at any given time a person may be competent to make decisions in one area of life but not in another. [44]  At the same time, the patient has the opportunity to achieve a deep understanding of the implications of the decisions made.  In this way, informed consent becomes a focal point of an ongoing therapeutic alliance in which the patient, assured of the clinician's involvement and support, is more likely to carry out the treatment plan and less likely to retaliate if a setback occurs.  Periodic review of the benefits and risks of the treatment chosen as well as of other treatment choices is helpful.  By creating an atmosphere of partnership, it can lessen the degree of dependence on the prescribing physician that a patient taking benzodiazepines may experience.  The meaning of the medication to the patient should be explored periodically as the nature of the treatment foci and the therapeutic alliance change in the course of a meaningful treatment.

The clinical benefits of a strong therapeutic alliance have long been evident to experienced clinicians.  Their observations have recently been confirmed by the NIMH research program on the treatment of depression, which documented the efficacy of an involved, caring approach to patients. [45]  In the treatment of substance abuse specifically, research has shown that patients have better outcomes when they can choose a form of treatment with which they are comfortable and in which they have confidence. [22,46]  This evidence of the clinical efficacy of informed consent supports practitioners who emphasize autonomy and authenticity as opposed to coercive indoctrination.

Legally, informed consent has taken on greater importance with rulings such as the Massachusetts appeals court decision which requires that a physician explore with the patient the risks and benefits not only of the recommended course of action, but of all available alternatives. [47]  This decision underscores the physician's responsibility to consider psychopharmacological as well as psychosocial alternatives to benzodiazepines. [48,49]  For example, Ambien (zolpidem) has been found to be a relatively safe, efficacious alternative for treatment of insomnia. [50]

Avoid prescribing medications in isolation from other therapies.  As with any other medications, benzodiazepines can be used most safely and effectively as part of an overall treatment plan, implemented and monitored in an ongoing therapeutic alliance.  Anxiety, like other forms of pain and discomfort, presents clinicians with a choice.  We want to alleviate the patient's suffering, and yet we don't want to suppress the warning signal the patient's anxiety gives us about what needs to be examined, and perhaps changed, in the patient's life.  Ideally, therefore, benzodiazepines should be used in conjunction with, rather than substituted for, some form of psychotherapeutic exploration, counseling, or behavioral treatment plan.  Short-term, focused use is the rule; however, with a specific therapeutic rationale, long-term use can be helpful.  While the anxious, isolated patient may be at particular risk for benzodiazepine dependence, integrating short-term psychopharmacological relief of anxiety with psychotherapy focused on conflict resolution and psychosocial integration may be optimal.

In practice, however, the patient whose immediate suffering the physician desires to relieve with a prescription may refuse or be unable to afford (either financially or emotionally) a more comprehensive intervention.  In such situations, the physician must consider the possibility that doing good in one way may do harm in another, both to the patient and (in today's punitive atmosphere) the clinician.  Seen in the most stark terms, the physician may need to choose in the short term between abandoning the patient or acceding to the patient's narcissistic wishes at the start of treatment.  The ethical conflict can be construed as being between supporting the patient's immediate (albeit drug-clouded) autonomy and a longer-term (arguably more authentic) autonomy. [51]

Be aware of the decision-making process.  High-risk situations such as these highlight the need to make decisions in a conscious, deliberate manner, with a deep understanding of the competing values and probable outcomes involved.  All the knowledge gained in psychopharmacology training will not reliably lead to wise, responsible, legally defensible decisions unless we apply the maxim "Know thyself" to medical decision making.  This involves an analysis of affect, information processing, and decision structure on the part of the prescribing clinician.  The former has been traditionally referred to as patient-evoked countertransference. [52]  The latter has been articulated, in the course of more recent discoveries in the psychology of decision making under conditions of uncertainty, as an individual clinician's awareness of heuristics and potential biases such as an overreliance on initial impressions or vivid past experience (e.g., availability bias). [53]  In daily practice we regularly use implicit decision trees; we need to make them explicit and share them with the patient whenever possible. [41]

Seek consultations.  Consultations with peers, supervisors, and others with specialized expertise can clarify the decision-making process, thereby raising the level of clinical care and strengthening the treating physician's position in administrative or legal actions.  In many cases, the consultation will be in a specialized clinical area such as psychopharmacology.  In cases with complex ethical and legal implications, forensic psychiatric expertise may be called for to address issues of risk-management, informed consent, and decision-making structure and documentation.

It is better, of course, for such consultation to be obtained prospectively than retrospectively.  By analyzing a difficult decision before the fact, the consulting psychiatrist can help the treating physician exercise responsible professional discretion in making recommendations to the patient.  After the fact, if an action against the physician has been initiated, the consultant can work with the physician to reconstruct the decision-making process and analyze and specify how informed consent was obtained.

Document the decision-making process.   At each stage of decision making, the physician working with patients at high risk for litigation can manage that risk by documenting not only what was done, but how that course of action was chosen.  From a risk-management perspective, a record should be kept of the informed-consent process, including assessment of the patient's decision-making competence, the patient's understanding of dependence and rebound, and the careful weighing by physician and patient of the risks and benefits of alternative courses of action.  A decision that runs counter to standard protocols can more easily be defended if it is not only carefully considered and voluntarily chosen by the patient, but also documented in a brief, but explicit and accurate fashion in the medical record.  Thus, whereas long-term treatment with low doses of benzodiazepines is within a physician's normal prerogatives, specific documentation of the appropriate use of chronic high-dose treatment is prudent.

Consider the ethical and legal implications of evaluating and prescribing by telephone.  Potential liability for drug prescription takes on an added dimension as medicine comes to be practiced increasingly by telecommunication rather than in person.  In the coming years, the problems that arise in relation to prescribing by telephone will be extended to the more general areas of evaluation and treatment via telemedicine. [54]  Some commentators [55] currently take the position that, "In general, medical practice without any clinical examination of the patient is contrary to medical ethics."  On the other hand, it may be the best available alternative under certain conditions.

Ethical and Effective Responses to Administrative or Legal Action
What should a physician do when facing administrative or legal action?  It is essential to review the existing documentation of the case.  It is equally essential for the physician, as well as for the physician-expert retained by the defense, to analyze and reconstruct honestly and deeply the decision-making process. [56]  Seeking consultation with colleagues and, if the process has advanced to the point of assembling a defense team, including early on an expert in psychiatric decision making can make a crucial difference.  The treating clinician also consults to the defense team to educate the attorney about the facts of the case, while the expert educates the attorney about the decision-making structure. 

Many attorneys, while familiar with the language of psychiatry, are less well versed in the principles of decision making.  In explaining how these principles were applied, the physician witness and the attorney should avoid the metaphor of psychiatry as an "art," which may suggest a retreat from responsibility, without going to the other extreme of confining themselves in an unrealistically rigid "bench" model of science.41  Unwarranted lawsuits pertaining to benzodiazepine prescription have been successfully defended on the grounds that the standard of care was met [57] or that a causal link between any deviation from the standard and the damages suffered was not established. [58]  The likelihood of such a successful defense is increased when the physician understands both how to give ethical and effective testimony and how to work with an expert retained by the defense attorney to communicate accurately the structure of decision-making trade-offs. [59]

Acknowledgments

The authors wish to thank Brian Johnson, M.D., both for his invitation to compose this essay and for his critical reading.  Two other colleagues also provided invaluable critical readings:  Lance P. Longo, M.D., and Carl Salzman, M.D., Dr. Bursztajn's first mentor in psychopharmacology, who still provides consultation and a much-appreciated deep understanding of the psychopharmacology and uses of benzodiazepines.  Thanks are also due those colleagues in the psychopharmacology group on the Internet who commented on working drafts.  Finally, the authors wish to acknowledge their 17-year collaboration with Thomas G. Gutheil, M.D., and members of the Program in Psychiatry and the Law at Massachusetts Mental Health Center.

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