General Principles of Psychopharmacotherapy with Children and Adolescents
William Klykylo
PSYCHIATRIC DIAGNOSIS AND PSYCHOPHARMACOTHERAPY
Psychopharmacotherapy should always be part of a comprehensive treatment plan arrived at after a thorough psychiatric evaluation that results in a diagnosis, or at least a working diagnosis. It is scientifically indefensible to initiate treatment without first attempting to formulate as clear an understanding of the clinical picture as possible. This will enable clinicians to institute the most appropriate and rational treatment(s) available in their therapeutic armamentaria for the situation at hand.
Current Psychiatric Diagnostic Nomenclature
A major difficulty with the official American Psychiatric Association (APA) nomenclature, the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) (APA, 2000), and indeed with most current psychiatric nomenclatures, is that etiology is not usually taken into account in formulating a diagnosis. One reason for this is that, at our present state of knowledge, we do not know the etiologies of many conditions. Hence, we are often treating specific constellations of behavioral symptoms without adequately understanding their biological and genetic underpinnings and how they interact with their psychosocial and physical environments. For example, autistic disorder is not etiologically homogeneous but has a multitude of causes.
Theoretically, for a given psychiatric disorder, drugs may be effective by correcting the condition(s) leading to it (or them) or by influencing events somewhere along the usually complex pathways between the hypothesized abnormality(ies) and its subsequent psychological and/or behavioral consequences. Therefore, some psychoactive drugs may be effective in several dissimilar disorders because they influence or modify neurotransmitters and
psychoneuroendocrine events in the brain along or near the end of these interacting, partially confluent, or final common pathways. Current research suggests that there are genetic bases for these phenomena (Cross-Disorder Group, 2013).
psychoneuroendocrine events in the brain along or near the end of these interacting, partially confluent, or final common pathways. Current research suggests that there are genetic bases for these phenomena (Cross-Disorder Group, 2013).
Other psychoactive drugs appear to exert their therapeutic effects through entirely different mechanisms in different diagnostic entities—for example, imipramine in depression, attention-deficit/hyperactivity disorder (ADHD), and enuresis.
Some patients with a specific diagnosis (e.g., ADHD, autistic disorder, or schizophrenia) will not have a satisfactory clinical response or will be refractory to a specific drug—even one known to be highly effective in statistically significant double-blind studies—or will even have a worsening of symptoms. This may reflect differences in genetic makeup or other biologically determined conditions, psychosocial environments, and/or internalized conflicts and the contributions each makes to the etiopathogenesis of each patient’s psychiatric disorder.
Although diagnostic issues are not discussed specifically in this book, it is emphasized that an accurate diagnosis is of critical importance in choosing the correct medication. At times, the lack of expected clinical response to a medication should suggest to the clinician the possibility of an incorrect diagnosis and that a careful diagnostic reconsideration should be undertaken.
Other unfortunate clinical consequences may result from incorrect diagnoses. For example, antidepressants may precipitate an acute psychotic reaction when given to some individuals with schizophrenic disorder. Stimulant medications, too, may precipitate psychosis when given in sufficient doses to some children or adolescents with borderline personalities or unrecognized schizophrenia.
Wender (1988) noted that clinical experience suggested that some children diagnosed with ADHD were treated with stimulants and rapidly developed tolerance to them but were actually suffering from a major depressive disorder and that they responded to treatment with tricyclic antidepressants with remarkable improvement.
Changing diagnostic criteria may also complicate matters. For example, some of the controversy regarding the efficacy of stimulants in patients with development disabilities may have resulted from diagnostic issues. Until the publication of DSM-II (APA, 1968), there was no specific APA diagnosis for what was commonly known as the hyperactive child. There were various labels for this condition, including hyperactive child, hyperkinetic syndrome, minimal brain dysfunction (MBD), and minimal cerebral dysfunction. Intellectual disability was considered evidence of more than “minimal” dysfunction, and the various etiologies were thought to be biological. Because of this concept, children with intellectual disabilities were excluded from the possibility of receiving a codiagnosis of MBD, hyperactive child, or an equivalent diagnosis, and some clinicians may not have tried stimulant medication in their patients who had even mild disabilities.
The situation changed with the publication of DSM-II, which noted that “in children, mild brain damage often manifests itself by hyperactivity, short attention span, easy distractibility, and impulsiveness” (APA, 1968, p. 31). It also suggested that unless there are significant interactional factors (e.g., between child and parents) that appear to be responsible for these behaviors, the disorder should be classified as a nonpsychotic, organic brain syndrome and not as a behavior disorder.
In DSM-III (APA, 1980a), the diagnosis of attention-deficit disorder with hyperactivity (ADDH) was based on the presence of a specific constellation of symptoms, and no etiology was hypothesized. Hence, children of any intelligence could exhibit such features. DSM-III additionally notes that mild or moderate mental retardation may predispose one to the development of ADDH and that the addition of this diagnosis to the severely and profoundly retarded child is not clinically useful because these symptoms are often an inherent part of the condition.
DSM-III-R redefines ADDH somewhat, renames it (ADHD), and refines its relation with mental retardation. It notes that many features of ADHD may be present in mentally retarded people because of the generalized delays in intellectual
development. DSM-III-R (APA, 1987), DSM-IV (APA, 1994), and DSM-IV-TR (APA, 2000) note that a child or adolescent with an intellectual disability should be additionally diagnosed with ADHD only if the relevant symptoms significantly exceed those that are compatible with the child’s or adolescent’s mental age. These changes in diagnostic criteria, although directed toward greater precision in identification and classification of disorders, have often complicated the process of treatment planning for clinicians.
development. DSM-III-R (APA, 1987), DSM-IV (APA, 1994), and DSM-IV-TR (APA, 2000) note that a child or adolescent with an intellectual disability should be additionally diagnosed with ADHD only if the relevant symptoms significantly exceed those that are compatible with the child’s or adolescent’s mental age. These changes in diagnostic criteria, although directed toward greater precision in identification and classification of disorders, have often complicated the process of treatment planning for clinicians.
DIAGNOSIS AND TARGET SYMPTOMS
In making the decision about which psychoactive medication to select initially, two major issues should be addressed: diagnosis and target symptoms. Both are important and are often interrelated. It is important to make the most accurate diagnosis possible using the available data and to identify and quantify target symptoms in order to choose an efficacious drug and to assess the results of medication. The target symptoms must be of sufficient severity and must interfere so significantly with the child’s or adolescent’s current functioning and future maturation and development that the potential benefits of the drug will justify the risks concomitant with its administration.
The initial medication may be chosen with respect to either diagnosis or target symptoms or both. Sometimes the decision is not difficult because the same medication is appropriate for both the target symptoms and the diagnosis. For example, antipsychotics are the drugs of first choice for treating schizophrenia and are appropriate for most of the significant target symptoms (e.g., hallucinations, thought disorder, and delusions). The symptom “hyperactivity,” however, is present in numerous childhood psychiatric disorders, but all hyperactivity is not the same (Fish, 1971). The clinician should be fully aware of the diagnosis in treating this symptom. Hyperactivity in a youngster with ADHD would be expected to respond favorably to the administration of a stimulant, whereas a schizophrenic youngster who is in relative remission but exhibits marked hyperactivity would have a risk of having his or her psychotic symptoms reexacerbated if stimulant medication were used. Stimulant drugs, the drugs of choice in ADHD, are sometimes considered to be relatively contraindicated in schizophrenia and may cause worsening of psychotic symptoms. More recently, however, clinicians have prescribed stimulants to psychotic children who are being maintained on antipsychotic medication but have the remaining symptoms of hyperactivity, distractibility, and inattention, with resulting further clinical improvement.
Medication can also be prescribed to treat specific diagnoses. Lithium, for example, has a certain specificity for treatment of mania in patients diagnosed with bipolar disorder, manic, but also appears to have an antiaggressive action that cuts across various diagnoses. Lithium has been used effectively to treat aggression directed against others or self-injurious behavior in children and adolescents diagnosed with conduct disorder, mental retardation with disturbance of behavior, and autistic disorder.
SPECIAL ASPECTS OF CHILD PSYCHOPHARMACOTHERAPY
Maturational/Developmental Issues
Physiologic Factors
The relation between biological developmental issues and psychopharmacotherapy has been long recognized and emphasized by Popper (1987b), Geller (1991), and many other authors. Children and adolescents may require larger doses of psychoactive medication per unit of body weight compared with adults to attain similar blood levels and therapeutic efficacy. It is usually assumed that two factors explain this situation: more rapid metabolism by the liver and an increased glomerular
filtration rate in children compared with that in adults. The latter suggests a greater renal clearance for some drugs, including lithium, which helps in explaining the fact that therapeutic dosages of lithium in children usually do not differ from those in adults (Campbell et al., 1984a).
filtration rate in children compared with that in adults. The latter suggests a greater renal clearance for some drugs, including lithium, which helps in explaining the fact that therapeutic dosages of lithium in children usually do not differ from those in adults (Campbell et al., 1984a).
Teicher and Baldessarini (1987) pointed out that children may respond to drugs differently compared with adults because of pharmacodynamic factors (drug-effector mechanisms) that are caused by developmental changes in neural pathways or their functions (e.g., Geller et al. [1992] reported that prepubescent subjects treated with the tricyclic antidepressant nortriptyline reported almost no anticholinergic adverse effects; especially noteworthy was the lack of any prominent dry mouth frequently reported by adults) or because of pharmacokinetic factors caused by developmental changes in the distribution, metabolism, or excretion of a drug.
Jatlow (1987) has noted that, although the rapid rate of drug disposition may decrease gradually throughout childhood, there may be an abrupt decline around puberty. Drug disposition usually reaches adult levels by middle to late adolescence. Clinically, this would indicate that the clinician should be especially alert to possible changes in pharmacokinetics during the time period around puberty and be ready to adjust dose levels if necessary. When they are available, it may be useful to obtain plasma concentration levels if there appears to be a change in the clinical efficacy of a drug as a child matures into an adolescent.
Puig-Antich (1987) summarized some of the evidence that catecholamine (norepinephrine, epinephrine, and dopamine) systems are not fully anatomically developed and operationally functional until adulthood. The fact that younger children may respond to stimulant medication differently from older adolescents and adults may be explained by the immaturity of the catecholamine systems (Puig-Antich, 1987); they can also be considered to result from developmental pharmacodynamic factors.
The pharmacokinetics of many drugs have been observed to change over the course of life. For example, children and adolescents below 15 years of age treated with clomipramine had significantly lower steady-state plasma concentrations for a given dose than did adults (Physicians’ Desk Reference [PDR], 1990). Rivera-Calimlim et al. (1979) reported that children and adolescents 8 to 15 years of age required larger doses of chlorpromazine than those required by adults to attain similar plasma concentrations.
There may also be differences between acute and chronic pharmacokinetics. For example, Rivera-Calimlim et al. (1979) reported a decline in plasma chlorpromazine levels in most of their child and adolescent patients who were on a fixed dose and suggested it might be due to autoinduction of metabolic enzymes for chlorpromazine during long-term treatment, as had been previously reported in adults. The consequences of autoinduction and its cellular basis have been extensively reported (Bonate and Howard, 2005).
A clear relationship between plasma concentrations and clinical response to imipramine was noted for prepubescent subjects and older adults with endogenous depression but not for adolescents and young adults (Burke and Puig-Antich, 1990). The authors hypothesized that the relatively poor clinical efficacy of tricyclic antidepressants in postpubescent adolescents and young adults compared with the clinical response of prepubescent children and older adults is secondary to a negative effect of increased sex hormone levels on the antidepressant action of imipramine.
Herskowitz (1987) reviewed the developmental neurotoxicity of pharmacoactive drugs. Developmental neurotoxicity is concerned with stage-specific, drug-induced biochemical or physiologic changes, morphologic manifestations, and behavioral symptoms. For example, stimulant medication may adversely affect normal increases in height and growth, at least temporarily, in some actively growing children and adolescents. Some psychoactive drugs taken during early pregnancy have significant potential for damaging the fetus (e.g., lithium may cause cardiac malformations).
Cognitive/Psychological/Experiential Factors
The maturation and development of the central nervous system as well as the life experiences accumulating since infancy determine much of the specific level of functioning of a given child or adolescent. Although detailed knowledge of these factors is essential to evaluate any child or adolescent psychiatrically, this book addresses only their specific relevance to psychopharmacotherapy.
In general, the younger the patient, the less the verbal facility available to convey information to the clinician and, reciprocally, the less the cognitive ability available to understand information the clinician wishes to impart. Part of the psychiatric evaluation leading to a decision that psychotropic medication is indicated will provide the clinician with an assessment of the level of the patient’s ability to communicate his or her emotional status and of his or her cognitive/linguistic ability to understand the proposed treatment and reliably report the effect of the treatment.
In the very young child or the child with no communicative language, the clinician can only observe behavioral effects of medication directly or learn of them as reported by others. The younger the child, the fewer the compliments or complaints about the beneficial or adverse effects. Also, the young child has lessdifferentiated emotions and more limited experience with feelings and emotions and with communicating them to others than do older children. In addition, some chronically depressed or anxious children may not have had a sufficiently recent normal emotional baseline with which they can compare their present mood. Such children may experience a depressed mood as their normal, usual state of being and, therefore, do not have a normal baseline frame of reference upon which to draw in describing how they feel.
The younger the child, the less accurate his or her time estimates. Until approximately 10 years of age, concepts of long periods of time are often not easily understood. It can be very useful and at times essential to use concrete markers of time in discussing time concepts and chronology of events with children. For example, the clinician may enquire whether something occurred before or after the last birthday, specific holidays (e.g., Christmas, Thanksgiving, or Halloween), specific events (e.g., separation or divorce of parents, when the family moved to another home, an operation, a relative’s death, or the birth of a sibling), the seasons or weather (e.g., winter, snow, cold, or summer, hot), or the school year (e.g., specific teacher’s name or grade, or Christmas, spring or Easter, or summer vacation).
Concepts such as concentration, distractibility, and impulsivity may be beyond the understanding of some early latency-age children. Different children may use different words or expressions to mean the same concept. It is important to be certain that a child knows the meaning of a specific word and not assume an understanding because the child responds to a question. If there is any doubt, ask what something means or explain it in another way. It can be very useful to ask the same thing in several different ways.
In the final analysis, once the patient’s psychopathology and his or her developmental experiential factors are taken into account, it is the quality of the relationship between the clinician and the child or adolescent that becomes paramount in determining the usefulness of information shared.
Relationship to the Patient’s Family or Caregivers
Diagnosis, Formulation, and Development of the Treatment Plan
A complete psychiatric assessment, including appropriate psychological tests, resulting in a working diagnosis and comprehensive treatment plan; appropriate physical and laboratory examinations; and baseline behavioral measurements should be completed as minimum prerequisites before the initiation of psychopharmacotherapy. The treatment plan should be developed in conjunction with either
the parent(s) or the primary caretaker and should include participation of the child or adolescent as appropriate to his or her understanding. Treatment with psychoactive drugs should always be part of a more comprehensive treatment regimen and is rarely appropriate as the sole treatment modality for a child or adolescent.
the parent(s) or the primary caretaker and should include participation of the child or adolescent as appropriate to his or her understanding. Treatment with psychoactive drugs should always be part of a more comprehensive treatment regimen and is rarely appropriate as the sole treatment modality for a child or adolescent.
At variance with this traditional wisdom, however, are the results of several studies comparing the treatment of hyperactive children with stimulant medication alone versus stimulant medication combined with other interventions, such as cognitive training, attention control, social reinforcement, and parent training. A review of these studies concluded that “the additional use of various forms of psychotherapies (behavioral treatment, parent training, cognitive therapy) with stimulants has not resulted in superior outcomes than medication alone” (Klein, 1987, p. 1223). One possible factor contributing to this result is that in several studies children who were treated with methylphenidate alone showed improvement in social behavior. Following this course of treatment, adults—both parents and teachers—related to the children more positively (Klein, 1987). The Multimodal Treatment Study Group of Children with Attention-Deficit/Hyperactivity Disorder (MTA) Cooperative Group also found that stimulant medication was the most important factor in improving ADHD symptoms. This is further discussed in Chapter 4 (MTA Cooperative Group, 1999a, 1999b).
It seems clinically unlikely, however, that all the difficulties of ADHD children are secondary to the target symptoms that improve with psychostimulants. Those difficulties that result from other psychosocial problems, including psychopathological familial interactions and long-standing maladaptive behavioral patterns, would be expected to benefit from additional interventions; until it is possible to differentiate those children whose difficulties arise from their attention deficit per se from children whose symptoms are of multidetermined origin, a comprehensive treatment program is recommended for all children. Obviously, this same principle applies to all psychiatric disorders, regardless of their responsiveness to medications.
The legal guardian/caregiver and the child or adolescent patient, to the degree appropriate for the patient’s age and psychopathology, should participate in formulating the treatment plan. The use of medication, including expected benefits and possible short- and long-term adverse effects, should be reviewed with the caregivers/parents and patient in understandable terminology. It is essential to carefully assess the attitude and reliability of the persons who will be responsible for administering the medication. Unless there is a positive or at least honestly neutral attitude toward medication and some therapeutic alliance with the parents, it will be difficult or infeasible to make a reliable assessment of drug efficacy and compliance. Likewise, to store and administer medication safely on an outpatient basis requires a responsible adult, especially if there are young children in the home or if the patient is at risk of suicide.
It should be explained to parents that, even if medication helps some biologically determined symptoms (e.g., in some cases of ADHD), the disorder’s presence may have caused psychological difficulties in the child or adolescent as well as disturbances in familial and social relationships. Controlling or ameliorating the biological difficulty does not usually correct the long-standing internalized psychological or interpersonal problems and long-standing maladaptive patterns of behavior immediately. Resolving these difficulties will take time and may often require concomitant individual, group, family, or other therapeutic intervention.
Compliance
Compliance is an issue of particular importance in child and adolescent psychiatry. Because the parents or other caretakers are usually interposed between the physician and patient, compliance is somewhat more complex than in adult psychiatry, in which the patient usually relates directly to the physician.
Obviously, for psychopharmacotherapy to be effective in the disorder for which it is prescribed, the drug should be taken following the prescribed directions. Erratic compliance or running out of medication may cause the patient to undergo what is in effect an abrupt withdrawal of medication. Withdrawal syndromes may sometimes be confused with adverse effects, worsening of the clinical condition, or inadequate medication levels. In some cases, such as when an antipsychotic is used, the patient is at increased risk for an acute dystonic reaction if the physician starts at the optimal dose after the drug has been discontinued for several days or more. In addition, when medication is stopped, it may sometimes require a higher dose of medication to regain the same degree of symptom control. For example, Sleator et al. (1974) found that 7 of 28 hyperactive children who showed clinical worsening during a month-long placebo period after having received methylphenidate for 1 to 2 years required an increase in dose to regain their original clinical improvement. Hence, it is very important to emphasize to parents that running out of medication is to be avoided.
Many factors may interfere with compliance. Some parents will at times withhold medication if their child appears to be doing well, or, conversely, increase the medication without the physician’s approval if behavior worsens, or even administer the drug to the child as a punishment.
When parents or legal guardians seek treatment for their children primarily because of pressure from others such as a school, a child welfare agency, or a court, there may be considerable resistance to both treatment and medication. Some of these parents may delay filling the prescription, lose it, or simply not fill it. Other parents consider it something to be done when convenient, especially if they have to travel any distance to get the prescription filled. If money is involved, even the amount necessary for travel to the pharmacy or to pay for the medication, some families, especially those on public assistance or very limited budgets, may have to delay purchasing the medication for legitimate financial reasons. These issues may come into play each time the prescription is renewed; additionally, it is common in many clinics for parents to miss appointments, including those when medication is to be renewed.
At times, some children and adolescents, both outpatients and inpatients, may actively try to avoid ingesting medication. Their techniques include pretending to place the pill in their mouths and later discarding it, and placing the pill under the tongue or between teeth and the cheek when swallowing and later spitting it out. Compliance in these cases may be improved if the person administering the medication observes it in the mouth and watches the patient swallow it. Crushing the medication may be helpful in some cases, but one must be certain that absorption rates will not be so significantly altered as to cause decreased clinical efficacy or adverse or toxic effects. If available, switching to a liquid form of the drug may be indicated for some patients.
Another factor that influences compliance, particularly in older children and adolescents, is related to adverse effects. For example, if they feel “funny” or different or if they develop a stomachache, they may be more reluctant to take medication. Adolescents may be especially sensitive to adverse effects affecting their sexual functioning. The more responsible a child or adolescent is for administering his or her own medication, the more likely, in general, that unpleasant, adverse effects will interfere with compliance. Richardson et al. (1991) reported that children and adolescents who developed parkinsonism while receiving neuroleptics were very aware of the symptoms and described them as “zombie-like” and a reason for noncompliance with outpatient treatment. These and other adverse effects can have similar influences on children and adolescents.
Noncompliance may be lessened sometimes if an adequate, understandable explanation of the simple pharmacokinetics of the drug is given to parents and patients when initially discussing medication. For example, the importance of
keeping blood levels fairly constant by taking the medication as prescribed can be emphasized and reviewed again if lack of compliance becomes important. Conversely, when parents continue to sabotage treatment consciously, unconsciously, because of their own psychopathology, or for other reasons, and this behavior seriously interferes with the psychiatric treatment of a child or adolescent, it may be necessary to report the patient to a government agency as a case of medical neglect and request legal intervention. Likewise, it may be necessary to discontinue medication if compliance is very poor or so unacceptably erratic as to be potentially dangerous.
keeping blood levels fairly constant by taking the medication as prescribed can be emphasized and reviewed again if lack of compliance becomes important. Conversely, when parents continue to sabotage treatment consciously, unconsciously, because of their own psychopathology, or for other reasons, and this behavior seriously interferes with the psychiatric treatment of a child or adolescent, it may be necessary to report the patient to a government agency as a case of medical neglect and request legal intervention. Likewise, it may be necessary to discontinue medication if compliance is very poor or so unacceptably erratic as to be potentially dangerous.
Explaining Medication to the Child or Adolescent
The clinician should discuss the medication with the child or adolescent as appropriate to the patient’s psychopathology and ability to understand. Giving the patient an opportunity to participate in his or her treatment is helpful for many reasons.
The patient can feel like an active partner in the treatment. This can alleviate feelings of passivity (i.e., that treatment is something over which the patient has no control). Letting the patient know that he or she should pay attention to the effects of the medication in order to report them to the therapist, that the patient will be listened to, and that the information the patient conveys will be considered seriously in regulating the medicine also helps the therapeutic relationship. The patient can also be informed that although medication may provide some relief or help, it cannot do everything, and he or she must still contribute effort toward reaching the treatment goals. This can be particularly important during adolescence, when issues of autonomy and control over one’s own body are normal developmental concerns.
Because the patient is experiencing firsthand the disorder being treated, in many cases valuable information necessary for regulating the medication can be obtained directly. Some fairly young children can express whether the medicine makes them feel better, more calm, or quiet; less mad or less like fighting; happier or sadder; less afraid, upset, nervous, or anxious; or worse, sleepy, tired, more bored, “madder,” or harder to get along with; and so on. Although parents or caretakers can provide much useful information, they may be unaware of some information that the patient can provide if time is taken to learn the words or expressions that the child uses to communicate feelings and experiences.
Adverse effects should be explained so that the child or adolescent understands them. The patient’s awareness that adverse effects may be transient (e.g., that tolerance for sedation may develop) or reversible with dose reduction may be helpful in gaining cooperation during the titration period. Foreknowledge also increases the sense of control and can decrease fear of some adverse effects. For example, if an acute dystonic reaction is a possibility, it is important to realize how frightening this can be to some patients (and their parents). Explaining beforehand that if this reaction occurs, medicine will help, and the condition will go away can make the experience less frightening. Also, if a rapidly effective oral medication such as diphenhydramine, an antihistamine with anticholinergic properties, is made available and patients and parents are aware of what is happening, the medication may be administered earlier in the process, frequently aborting a potentially more severe reaction.
Children who ride bicycles and adolescents who drive a car, motor bike, or motorcycle, or operate potentially dangerous machinery should be cautioned if a medication may cause sedation or other impairment. They should be told to wait until they are sure how they are reacting to the medication before engaging in these activities. Similarly, if an adolescent is likely to use alcohol or other psychoactive drugs, he or she should be warned of possible additive or other adverse effects. Drugs like monoamine oxidase inhibitors are too risky to recommend except in very cooperative patients who are able to follow the necessary strict dietary restrictions to avoid a potential hypertensive crisis.
Medicolegal Aspects of Medicating Children and Adolescents
Medicolegal issues usually involve concerns about the clinician’s clinical competence or performance. These issues arise primarily when something goes wrong. Incidentally, that “wrong something” may have nothing to do with the clinician’s specific treatment or competence but may, for example, be an outcome that displeases the patient or guardian. Even then, for a medicolegal issue to arise, someone who has become aware of it must decide to pursue the matter legally.
The importance of these issues is that the clinician’s relationship with the patient and his or her family or caretakers can either increase or decrease the likelihood of legal proceedings. As a general rule, the better the quality of the relationship and rapport between the physician and the patient and his or her family, the less is the likelihood for legal proceedings to occur. Parents who are angry at their child’s physician, who feel neglected or not cared about, are more likely to institute legal proceedings. Taking time to explain what the medicine may and may not do is important; no medication can be guaranteed to be clinically effective and safe for every patient.
If there is a risk that a depressed patient may attempt suicide but the patient is not hospitalized, this should be discussed with all concerned parties. Public perception of the association of suicidal ideation with a number of psychotropic agents has intensified the importance of these concerns. The patient may be asked to commit verbally or in writing to a contract to contact the clinician before any attempt to take his or her own life. Legal guardians should be informed of and concur with the decision that their child or ward will not be hospitalized and that, although there is a risk, the degree of risk is acceptable to avoid hospitalization. The guardians should be asked to provide more formal supervision until the depression improves sufficiently. If such measures are carried out and documented and a working rapport established, the risk of legal action and/or liability will be lessened should a suicide attempt, successful or otherwise, occur.
The clinician should make a genuine effort to establish a working rapport with parents who have consented under duress to the treatment of their child or adolescent (e.g., if their child has been removed from their care by a governmental agency because of abuse or neglect or where medication may be a prerequisite for remaining in a particular educational program), although this is frequently difficult.
Holzer (1989) noted that most, if not all, malpractice claims occur in cases with either an unexpected clinical outcome or an event that is perceived by the patient (or parents) as avoidable or preventable. The aspects of psychopharmacotherapy that have potential for medicolegal implications parallel this book’s entire section on general principles of psychopharmacotherapy. Lawsuits are most frequently brought if something is omitted or if something goes wrong that could reasonably have been prevented. It should be emphasized that proper documentation in the clinical record is essential. If this is not done, the clinician’s position is precarious if legal difficulties arise. The ascendancy of electronic health records (EHRs) has made it possible for physicians to document more fully their assessments and interventions; but electronic health records have made every aspect of patient care easily discoverable. Particular areas of concern are discussed later.
For a comprehensive overview of malpractice issues in child psychiatric practice, see Benedek et al. (2010).
Ethical Issues in Child and Adolescent Psychopharmacology
Ethical concerns are paramount in the practice of psychiatry, and especially with children, because of their inherent vulnerability and their special reliance upon others and their environment. Contemporary medical ethics rests upon a set of major principles (Veatch, 1991): beneficence, maleficence, autonomy, veracity, fidelity, and avoidance of killing. These principles are often designated consequentialist (beneficence and nonmaleficence—having to do with good outcome) and nonconsequentialist (having
to do with inherent morality—autonomy, fidelity, veracity, avoidance of killing, and justice). Although many today assign a higher lexical ranking to the nonconsequentialist principles, this stance may be questioned in view of the vulnerability of children and their inherent lack of autonomy. In any case, it is the duty of the practitioner to recognize and balance appropriately the application of these principles.
to do with inherent morality—autonomy, fidelity, veracity, avoidance of killing, and justice). Although many today assign a higher lexical ranking to the nonconsequentialist principles, this stance may be questioned in view of the vulnerability of children and their inherent lack of autonomy. In any case, it is the duty of the practitioner to recognize and balance appropriately the application of these principles.
The consequentialist principles of beneficence and nonbeneficence are usually the instinctive first consideration of clinicians. All medications that we use have both desirable and adverse effects, and each prescription represents an attempt to balance these effects for an individual patient. The history of psychopharmacology is replete with misapprehensions of these. The neuromuscular and metabolic effects of neuroleptics compared with their limited effectiveness in many off-label uses are a prime example.
Another such example would be the use of a psychostimulant in the child whose inattentive behavior in school results not from an attention deficit disorder but from a language-based learning disability. The child would demonstrate less activity when receiving the medication to the possible satisfaction of adults; however, this child would not be adequately educated, and the occurrence of dysphoria or other adverse effects might hurt the child.
It is an intrinsic duty (based on the principle of fidelity) for a physician to pursue beneficence and avoid maleficence. It is obvious that a physician can do so only with a comprehensive biopsychosocial diagnostic understanding of the child patient. The physician must also have as full a familiarity as possible with the effects of any agents to be considered. Ignorance is unethical.
The consequentialist principles present a more nuanced challenge. Avoiding killing is a clearly defined and almost universally accepted principle among physicians, despite concerns about euthanasia. Fidelity, the adherence to behavioral and professional standards, in the context of a doctor-patient relationship based on a social contract, is universally accepted. Justice in the context of medical ethics refers to the allocation of resources among a larger population; its application involves a range of political and cultural issues that are constantly debated.
Veracity in today’s context requires not only the avoidance of falsehoods but the telling of the “whole truth.” Two complications arise here. First of all, doctors and patients considering pharmacologic treatment face an intimidating volume of information. The pages of fine print in the Physicians’ Desk Reference are intimidating to many patients and families and contain information of varying relevance to physicians. The full possibility of adverse effects from any agent can never be absolutely known. In this situation, physicians should offer as much information as they judge families can digest at a given time, with the added proviso that other information is available, that it can be acquired from the physician and other sources, and that no other information can be absolutely complete. At times, physicians fear that information may be daunting to families and will discourage the acceptance of beneficial agents. Parents almost always do have the autonomous right to refuse to give psychotropic agents to their children, despite the concerns of physicians. Coercion is usually unethical and seldom successful. These issues can be resolved only through communication, and the ability to communicate with authority, empathy, and clarity is as essential as skill and psychopharmacology as is scientific knowledge (Krener and Mancina, 1994).
The second complication of veracity is the cognitive level of the child patient. One must provide a clear and developmentally appropriate explanation of risks, benefits, and possible adverse effects of medication; this is important not only from an ethical standpoint but also to assure that the child can recognize positive and/or adverse effects and report them.
Autonomy is the most complicated ethical issue in child psychopharmacology. In general, parents have absolute authority in decisions related to the treatment of minor children. Concurrently, however, children, despite their intrinsically
limited autonomy, are seen as having the right to assent or refuse treatment. Assent is “agreement obtained from those who are unable to enter a legal contract” (Ford et al., 2007). Dockett and Perry (2011) describe assent as “a relational process whereby children’s actions and adult’s responses taken together reflect children’s participation in decisions”; this is an interactive process. In their masterful review, Krener and Mancina (1994) describe various models for decision making and demonstrate that autonomy in child patients, as well as compliance, is engendered by a communicative rather than an authoritative or prescriptive stance.
limited autonomy, are seen as having the right to assent or refuse treatment. Assent is “agreement obtained from those who are unable to enter a legal contract” (Ford et al., 2007). Dockett and Perry (2011) describe assent as “a relational process whereby children’s actions and adult’s responses taken together reflect children’s participation in decisions”; this is an interactive process. In their masterful review, Krener and Mancina (1994) describe various models for decision making and demonstrate that autonomy in child patients, as well as compliance, is engendered by a communicative rather than an authoritative or prescriptive stance.
This same principle is obtained in addressing the autonomy of parents or guardians. In rare cases, this autonomy may be superseded by legal interventions as in overt abuse or neglect; however, this almost never occurs regarding issues of psychopharmacology. Consequently, for both ethical and pragmatic reasons, the clinician must respect the nearly total autonomy of parents. Krener and Mancina provide models and examples for decision making. In all of these cases, there is a framework of communication that is respectful, empathetic, and complete.
The most specific application of autonomy arises in informed consent. Today, most physicians are aware of the absolute necessity for documentation of informed consent to all treatments, for legal as well as ethical reasons. Informed consent involves information and voluntariness. Patients and families are provided with diagnosis, the nature and purpose of a treatment, and the risks and benefits of a proposed treatment versus alternative treatments or no treatment (AMA, 2012). These principles have become accepted throughout much of the world (Malhotra and Subodh, 2009).
A special problem that involves all the principles of ethics arises from the use of psychotropic agents in the face of inadequate or inappropriate psychosocial services and environmental settings. This most often occurs with the intent of managing or attenuating aggressive behavior. At this writing, massive public attention is being directed toward the alleged misuse or overuse of psychotropic agents, notably neuroleptics among children in foster care (Kutz, 2011). Similar concerns have been raised for children in other treatment settings (MMDLN, 2011). It is charged that these medications have been given involuntarily (autonomy) and without full information (veracity) to children. Adverse effects have arisen (non-maleficence) with few if any concurrent benefits (beneficence). Implicit and often explicit accusations are made that these agents are used for behavioral control in the absence of appropriate environments and psychosocial treatments (justice). Clinicians involved in these issues may be overwhelmed by massive numbers of needy children and very sparse treatment resources. In certain circumstances, they may opine that medications given even under the stated circumstances but in a resource-starved setting may constitute a more beneficent alternative than placement in more restrictive settings, multiple brief foster or residential placements, incarceration, or abandonment. The obvious answer to this ethical dilemma is the development of comprehensive environmental and treatment resources. In the absence of that blessed circumstance, clinicians must approach these questions with a broad awareness of all the ethical principles involved applying them with both rationality and sensitivity; this approach to ethics facilitates all medical practice. The Codes of Ethics and the Ethics Committees of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry can provide assistance in assessing these dilemmas (Sondheimer and Klykylo, 2008).
Treatment Planning
Issues Concerning Diagnosis and Implications for Drug Choice and Premedication Workup
The areas of major concern are making a correct psychiatric diagnosis and being aware of any coexisting medical conditions. Taking accurate medical and psychiatric histories, including previous medications and the patient’s response to them as
well as adverse effects and allergic reactions, is essential. Nurcombe (1991) notes that if adverse reactions to a drug or drug interactions occur that could have been predicted by taking an accurate and adequate history, the physician may be held liable. History taking must be followed by a proper premedication workup; if the patient has a medical condition, the physician must consider how the psychotropic medication would affect that condition and whether there may be interactions with other medications the patient is taking. Some examples of this include the following: (a) making an incorrect diagnosis and prescribing the wrong medication, or failing to detect or recognize coexisting conditions that would contraindicate the chosen medication; (b) prescribing a drug that will interact adversely with another medication the patient is taking or a drug to which the patient has previously been allergic; or (c) failing to perform a baseline and serial electrocardiograms (ECGs) or to monitor serum levels when tricyclics are used because of possible cardiotoxicity.
well as adverse effects and allergic reactions, is essential. Nurcombe (1991) notes that if adverse reactions to a drug or drug interactions occur that could have been predicted by taking an accurate and adequate history, the physician may be held liable. History taking must be followed by a proper premedication workup; if the patient has a medical condition, the physician must consider how the psychotropic medication would affect that condition and whether there may be interactions with other medications the patient is taking. Some examples of this include the following: (a) making an incorrect diagnosis and prescribing the wrong medication, or failing to detect or recognize coexisting conditions that would contraindicate the chosen medication; (b) prescribing a drug that will interact adversely with another medication the patient is taking or a drug to which the patient has previously been allergic; or (c) failing to perform a baseline and serial electrocardiograms (ECGs) or to monitor serum levels when tricyclics are used because of possible cardiotoxicity.
Issues Concerning Informed Consent
The treatment plan should be discussed and agreed to by the legal guardian and the patient as appropriate for his or her age and understanding. The diagnosis and the risks and benefits of the proposed treatment and alternative treatment possibilities should be reviewed. To give informed consent, a patient (or legal guardian) must be mentally competent, have sufficient information available, and not be coerced. Adolescents 12 years of age and older should participate formally in developing their treatment plans and in giving informed “assent.” If this is not possible, it should be so stated in the clinical record. It is wise to have both the legal guardian and, when appropriate, the patient sign the treatment plan and/or an informed consent (“assent” for underage individuals) for medication. If this is not done, at a minimum the clinician must document the discussion of the treatment plan and the response of the patient and legal guardian in the clinical record. Nurcombe (1991) recommends that the following be discussed: