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Psychopharmacology for Mental Health Professionals: An Integrative Approach, Second Edition
- Elliott Ingersoll and Carl F. Rak
© 2016, 2006 Cengage Learning
CHAPTER FOUR
Psychological, Social, and Cultural Issues in Psychopharmacology
This chapter is divided into four sections. Section One provides an overview of issues surrounding adherence and compliance with medication prescriptions. Section Two addresses how to speak with clients about medications. Section Three covers the new subdiscipline of ethnopharmacotherapy and Section Four provides an overview of how institutions like pharmaceutical companies are impacting mental health practice.
SECTION ONE: ADHERENCE AND COMPLIANCE WITH MEDICATION REGIMENS
Learning Objectives
- Understand the difference between compliance and adherence.
- Be able to discuss the different ways clients conceptualize their symptoms.
- Be able to discuss common reasons people do not comply with medication regimens.
- Know the predictors of noncompliance and therapeutic ways to work through them with clients.
Many psychological issues that clients have related to psychotropic medications are illustrated in discussing compliance with medication. Even when a person suffers from terrible ego-dystonic symptoms, if taking medication is incongruent with the person’s self-image, noncompliance or nonadherence may be an issue. Compliance is the overall extent to which a client takes medication as prescribed. Adherence is more specific, referring to the extent that the client takes the prescribed medication at the exact time and in the correct dose (Demyttenaere, 2001). We include adherence in our general discussion of compliance.
We recall one client (Agnes) who interpreted taking a medication as a sign of weakness that she avoided thinking about. Agnes had lost her husband one month before she consulted a physician for her “nerves.” Her physician was torn as to the best course of action. Under earlier diagnostic manuals (e.g., DSM-IV-TR, APA, 2000), she was experiencing uncomplicated bereavement, which is a developmentally normal event following loss of a loved one. However, she was not eating or sleeping, and met the DSM-5 (American Psychiatric Association [APA], 2013) criteria for a Major Depressive Episode. DSM-5 omitted the exclusion not to diagnose someone with depression if they had just lost a loved one [a move many in the field are critical of (Frances, 2013)].
Agnes asked if there were medication to “calm her nerves” but then became agitated stating that taking the medication would be a sign of weakness. The doctor wisely refrained from prescribing and connected Agnes with grief counseling. In the counseling sessions, Agnes revealed that the bottom line was “anyone who would take a pill for their mind is crazy.” Her response was clearly related to her own perceptions of psychotropic medication, which reflected the cultural stigma attached to mental/emotional disorders, particularly for a woman in her 70s.
Understanding such stigma is an important variable in understanding clients who may resist or feel conflicted about taking medication (Knudsen, Hansen, Traulsen, & Eskildsen, 2002), but the stigma seems to vary from generation to generation; from culture to culture (Britten, 1998; Priest, Vize, Roberts, & Tylee, 1996). Mental health professionals must be willing to commit the time with clients to explore issues such as stigma. For Agnes, cognitive techniques helped her reframe and metabolize her grief but ultimately her mind was made up about psychotropic medication and, right or wrong, it was not of therapeutic value to challenge it.
CLIENT REACTIONS TO THE MEDICAL MODEL OF MENTAL ILLNESS
Some qualitative studies examine the way clients perceive the medical model description of their symptoms. In one study of women suffering from symptoms of schizophrenia (Sayre, 2000), most of the sample seemed to have been given a medical model explanation of their symptoms (e.g., “Schizophrenia is a brain disorder”). Client responses fell into six general categories. The members of one group more or less accepted the disease explanation and viewed their problems as related to some externally caused illness that could be treated with medication. The members of another group (labeled the “problem group”) saw their symptoms as arising from personal qualities and behaviors that were the root causes. The members of a third group (the “crisis group”) viewed their symptoms as a response to some crisis or other recent stressor. In a fourth group (the “ordination group”), the members saw their symptoms as a sign of special powers or responsibilities. Although this explanation is similar to tales of initiation told in shamanic traditions of many indigenous people, in this case the explanations were more consonant with the symptom profile than any spiritual crisis. In the fifth group (the “punishment group”), members saw their symptoms as punishment for past actions. In the final group (the “violation group”), members viewed their hospitalization as an attack on them by hospital staff and the idea that they had an illness an excuse for detaining them. In the case of schizophrenia, although there is strong support for a theory of biological etiology, the symptom presentation is still heterogeneous.
Even if a clinician believes the etiology of a disorder is more physical than mental (e.g., more brain than mind), it is important for the therapeutic relationship to consider the way a client makes meaning of his or her symptoms. Clearly, some perceptions of illness recorded in the Sayre (2000) study may reflect the illness more than they represent any personal or cultural aspects of the client. For example, illusions or hallucinations may be perceived as a sign of special powers (as in shamanic initiation) but also may reflect megalomania, which manifests in many people suffering from severe disorders such as schizophrenia or Bipolar I Disorder.
It is important to remember that some clients prefer to use the medical model perspective to explain their symptoms. In such cases, a psychological perspective can help counselors understand why some clients have this preference. Although ideally clients will become able to face all the variables related to their symptoms, this may take time. In some cases of depression, the medical model may provide a good explanation; however, where the depression is overdetermined, the medical model may serve as what Yalom (1995) called an “explanatory fiction”—an explanation that is more allegory than fact corresponding to some external truth. One client (let’s call him James) had low self-efficacy and was actively suicidal. This followed a series of difficult life events, including the loss of a job, being dumped by a longtime girlfriend, and the death of his mother from pancreatic cancer. Clearly, these life experiences were strongly related to his depression but for James, the explanatory fiction of his depression as a medical illness made it easier to accept help in the form of counseling and antidepressant medication. James took the antidepressants for eight months while also engaging in counseling. After eight months, his doctor titrated him off the medication. James terminated the counseling relationship after one year, at which time he was functioning much better.
The medical model as explanatory fiction or useful metaphor is illustrated in the notion that alcoholism (or any substance dependence) is a “disease” with a biological etiology. This notion is not supported by science or logic (Ross & Pam, 1995), but rather on the agenda of the group defining it. The Veterans’ Administration does not refer to alcohol dependence as a disease while the American Medical Association does. Defining alcohol-related problems as a “disease” can also steer us away from research supporting moderation management in some drinkers [e.g., some people can have an alcohol problem at one point in their life then return to moderate drinking (Hester, Delaney, & Campbell, 2011)]. On the constructive side, the metaphor of alcohol dependence as a disease has helped some clients avoid becoming crippled by guilt and self-recrimination so they can more fruitfully engage in treatment. Certainly the reverse holds true as well—some clients use the metaphor of alcoholism as a disease to avoid taking any responsibility for their drinking (“I can’t help it—I have a disease”). Ethically, the clinician needs to know when the medical model perspective seems to be the best explanation for symptoms and when it seems the best metaphor to help the client engage in treatment. When metaphors are mistaken for facts, however, the potential exists for damaging word magic. One example is that in many polls, Americans believe that people who once have a problem with alcohol must abstain totally for the rest of their lives (Lillenfeld, Lynn, Ruscio, & Beyerstein, 2010) while more and more research supports that some (but not all) people can learn moderation management (Hester, Delaney, & Campbell, 2011).
Another example of metaphor gone wrong was a case of a fifth-grade student that I (Ingersoll) consulted on. The student was diagnosed with attentiondeficit-hyperactivity disorder (ADHD), with an inattentive specifier (in DSM-5 criteria). The school counselor and I learned that the diagnosis had been made in a physician’s office without an assessment of the child’s behavior across several settings. The child appeared inattentive because in school she would unpredictably stare off into space or get up and meander around the classroom. The physician told the parents that their child had a “chemical imbalance.” They took this to mean that the medication (a stimulant in this case) would correct the problem. Although the medication seemed to help the daydreaming, it also seemed to exacerbate the behavior of getting out of her chair and wandering around the room. The school counselor and I referred the child to a specialist who helped children with mild to moderate symptoms of ADHD. The parents agreed, and the counselor worked with the student on learning how to concentrate and helped the parents and teacher at the school cue and reinforce appropriate behavior in the student. After six months, the child was able to be titrated off the medication. Had the parents continued under the assumption that their child had “a chemical imbalance,” the child might not have received the help she needed or would have received it later than she did.
Even though a client may prefer a medical model explanation of symptoms because it is less threatening to his or her sense of self, mental health professionals must resist being caught up in the word magic of the medical model. We recall attending a presentation at a professional conference where the presenter lectured for three hours on the biological bases for mental disorders, without producing one reference or fact to support his thesis. He seemed far too mesmerized by the medical model to bother to provide factual support for his claims. Even though he was trained in psychosocial interventions, he did not mention the ones we know are effective for many of the disorders he covered (such as ADHD). In addition, this psychologist supported the movement to give psychologists the legal power to write prescriptions for psychotropic medications. As such, he was clearly biased. A better approach would have been to set his presentation in the context of his position that psychologists should be allowed to prescribe psychotropic medications.
A study of adolescents with mental/emotional disorders summarized their perceptions of treatment. These teenagers shared the common negative perception that staff relied too much on the medical model to explain depression. They reported that the staff seemed to just want to give them medication and to not talk to them about what was really bothering them (Buston, 2002). What was “really bothering them” in this case were psychological and cultural variables that they saw as related to their depression. These adolescents wanted to discuss their psychological perspectives with clinicians rather than just have their symptoms described as a disease process treatable with pills. More recent studies confirm that children and adolescents will often resist taking medication (Worley & McGuinness, 2010) many times for reasons that can be addressed in counseling like fearing personality changes, social stigma, and concerns about addiction (Hamlin, McCarthy, & Tyson, 2010).
Perhaps the best way to begin this section is to ask the reader a simple question. Have you ever (1) not taken a medication as directed, (2) taken more of a medication than prescribed, (3) taken less of a medication than prescribed, (4) stopped taking a medication before your doctor recommended it, (5) resumed taking a medication left over from an earlier prescription without checking with your doctor for the new episode? If you have done any of these, you have not followed—technically, you have been noncompliant with—a medication plan. (When we ask this question in class, 80 to 90% of our students raise their hands; we do, too.) Researchers estimate that only 50% of people on any prescription medication always take it as prescribed (Patterson, 1996).
Although there is no absolute way to predict which clients will be most compliant with medication regimens, some characteristics can be assessed. We have long known that adherence rates vary across racial/ethnic demographics (Cuffs et al., 2013; Diaz, Wood, & Rosenheck, 2005) with people of color reporting adherence rates between 66 and 77% while Caucasians report adherence rates around 90%. We also know that the younger the person taking the medication, the less adherence they exhibit (Worley & McGuinness, 2010). In general, people who follow medication plans are usually emotionally mature, in stable family situations, employed, and pay for their own or part of their treatment. This profile implies that the further along a client is developmentally, the more likely he or she is to follow a medication plan. Although there are dozens of lines of development, some key lines such as cognitive, emotional, and ego development seem particularly germane here. When you talk to a client about medication, you must consider his or her developmental level as well as lifestyle to get a sense of how compliant that person is likely to be. Predictors of noncompliance include being male, being young, and experiencing severe side effects (Demyttenaere, 2001).
It is also important to examine the clinician’s attitude toward compliance. Many interns go into a mental health field with the misconception that part of their job is to make sure the client stays on prescribed psychotropic medications. This is untrue and may reflect anything from unresolved power issues, to poor training, to the unresolved power issues of their supervisors in the field. It is not the job of a mental health professional to make sure clients stay on their medications. It is the job of a mental health professional to help clients weigh the benefits and risks of taking medications, to help clients process conscious and unconscious resistance to medication, and to work with any number of theories to explore the risks and benefits of medications and how the medications relate to the goals a client has set in counseling. In the end, it is always the client’s choice whether or not to take medications, even when not doing so will likely result in incarceration or confinement in a more restrictive treatment setting.
REASONS THAT CLIENTS MAY NOT COMPLY
When the noncompliance issue arises, mental health professionals must explore it with clients. Noncompliance can be caused by many things, including cost of the treatment, forgetfulness, and client values and beliefs (Demyttenaere et al., 2001). Beck, Rush, Shaw, and Emery (1979), who initiated research on irrational beliefs that contributed to noncompliance, concluded that clients on antidepressants were often noncompliant because of irrational thoughts about their medications. These researchers found the following three irrational thoughts among the primary ones associated with medication noncompliance: “The medication won’t work,” “I should feel good right away,” and “My depression is incurable.”
Sometimes the client just thinks the drug will not work, without any evidence to support that notion. You may find the client has a pessimistic worldview— part of what Beck et al. (1979) called the cognitive triad of depression. Another possibility is that perhaps the client is involved in what is called a negative feedback loop. In a negative feedback loop, the client for some reason stopped getting reinforcers that up to a point were satisfying. An example is when a client suffers the breakup of a romantic relationship that he or she experienced as reinforcing. The result of losing these reinforcers was depression, but the depressive symptoms then began prompting reactions in other people, reactions that became reinforcing. In the latter example, assume the client then started getting more calls from friends who were concerned about him or her. Those calls then become reinforcing and, rather than seeking out another relationship, the client may come to rely on those calls. This pattern is colloquially referred to as “getting some secondary gain from the symptoms.” In such cases, clients prefer to believe no drug will work for their symptoms, because if they lose the symptoms they lose the secondary gains.
It would be ideal if all medications worked immediately. But that simply is not the case with most psychotropic medications, particularly antidepressants, that may take anywhere from two to six weeks for the full therapeutic effects to manifest (when they do work). Counselors and other therapists must help clients deal with the early onset of side effects and later onset of therapeutic effects. It is wise to let the client describe how he or she is feeling before the counselor asks direct questions about non-life-threatening side effects. In some instances (outlined by Greenberg & Fisher, 1997), side effects actually have some placebo value in that the client may interpret them as the medication “working.”
If a client seems to feel his or her depression is incurable, here again counselors should investigate what possible secondary gains the person may be getting from the symptoms (the negative feedback loop may be operating). This belief may also be a manifestation of one aspect of the cognitive triad of depression. Readers may recall that Aaron Beck stated that the cognitive triad of depression was comprised of negative feelings about self, the world, and the future. A third possibility is that the client actually has a subtle death wish and is mentally prepared to decompensate (decline in functioning) to the point where he or she may have the nerve to attempt suicide. A final possibility is that the client has engaged in several unsuccessful treatments and has come to believe there is no treatment for his or her condition. Taking a thorough treatment history is invaluable in identifying this last dynamic.
Patterson (1996) added that clients may not comply with their medication plan because of trouble with routines, or inconvenience; medication as evidence of an undesirable self; misinformation; and other issues.
Trouble with Routines, or Inconvenience
Trouble with routines, or inconvenience, is often a problem for clients with impaired cognitive functioning. The client may forget or become confused about the medication regimen, grow tired of taking the medication, or may not be able to afford the medication (or believes she or he can’t afford it). Clients who do shift work, for example, may have changes in routine that hinder remembering when to take medication. This is one reason pharmaceutical companies try to develop medication formulations that allow once-daily doses or even intramuscular injections that let a client get the medications injected once a month.
Problems of inconvenience often relate to side effects. One client we treated felt lethargic and sedated when taking her medication. She worked in a university setting as a recruitment coordinator. Her job required enthusiastic presentations and campus tours throughout the day. This particular client felt the side effects made her job much more difficult. The extra effort to get through the workday was so inconvenient that she responded by stopping her medication.
Medication as Evidence of an Undesirable Self
The notion that taking medication shows undesirable personal traits is particularly important when considering the client’s psychological perspective. Such a client may believe that requiring medication is a sign of weakness or indicates some flaw or stigma related to mental illness. The client may be embarrassed at the prospect of other people finding out about her or his taking medication. Other clients may say they feel they are not their “real selves” while on medication. Although this may in fact be true, it is also possible that the client has been experiencing symptoms for so long (as in Persistent Depressive Disorder [previously called Dysthymia] in DSM-IV) that he or she has included the symptoms in his or her definition of “real self.” Generally speaking, clients who negatively interpret taking medication are concerned about losing control over their lives. They may feel their symptoms have taken control of their lives to some extent and that the medications further decrease their control. This resistance can be complicated by paranoia that is part of the client’s symptom profile or that arises when the client (sometimes for good reasons) does not trust the therapist or prescribing physician.
In such cases, one excellent strategy is based on Rogers’s (1957) six core conditions of constructive personality change. First, make sure the client is capable of making psychological contact. Clients with psychotic or manic symptoms may not be able or willing to make psychological contact. Second, if the client is able/willing to make psychological contact, Rogers’s conditions posit that he or she is in a state of incongruence between ideal self and what he or she currently perceives as the self. In this situation, we assume that the lack of congruence is related to mental/emotional symptoms and the prospect of taking medication for those symptoms. Third, Rogers stipulates a therapist who is congruent, meaning that he or she is aware of both the client’s ideal and current sense of self, how they overlap and where they may not. Fourth, the counselor experiences unconditional positive regard for the client. In this case, unconditional positive regard includes a nonjudgmental acceptance of the client’s conflicts about taking the medication, including an acceptance of extreme feelings (e.g., some clients say they would rather die than take medication). Fifth, the counselor experiences an empathic understanding of the client’s perspective, and sixth, when the counselor experiences this empathic understanding of the client he or she conveys it to the client. When these conditions are met the stage is set, according to Rogers, for constructive personality change—in this case, dealing with medication issues. If you are using another model of counseling, remember that it is most helpful to clients to work with a counselor who is empathic and willing to talk with them about their fears related to psychotropic medications.
Misinformation can be an easily remedied reason for noncompliance. In some cases, fixing misinformation simply requires referring the client to a credible source of information or sharing that information in the counseling session. One problem is related to the labels categories of the medications have. One client, who was taking olanzapine (Zyprexa) to control his symptoms of Bipolar I Disorder, heard that the medication was an “antipsychotic” and promptly replied, “Well, I’m not psychotic, so that must be the wrong medicine.” A good part of an entire session was spent discussing how such medicine categories are labeled and how they really do not relate well to different uses with different clients. To the notion of misinformation we add the idea of disinformation contamination. Disinformation is the intentional spreading of information that is patently untrue, for political or other purposes. When disinformation concerning drugs (such as “All drugs cause addiction”) contaminates a client’s consciousness, it is possible that person may then assume any drug, even one that could help, is more dangerous than it actually is. The U.S. government’s “war on drugs” has been built on disinformation for political purposes, such as labeling marijuana and heroin “narcotics,” which gives the impression that they are similar substances (they are not). Another example is when the government sponsored researchers who claimed their studies showed that the drug 3,4-methylenedioxy-N-methylamphetamine (MDMA) caused literal holes in the brain (Ricaurte, Yuan, Hatzidimitriou, Cord, & McCann, 2002). When his conclusions could not be replicated and were challenged Ricaurte claimed that the facility that dispensed the drug for his study gave him methamphetamine instead of MDMA (a labeling error he claimed). He later retracted the paper (Ricaurte, 2003). Disinformation like this only makes citizens more mistrustful of government spokes-people. Until the government accepts a reasonable policy on drug use and tells the truth about what we do know, disinformation will continue to contaminate the thoughts of the public regarding all medications.
Sometimes, when symptoms are controlled, a client believes she or he is cured (as with an antibiotic) and stops taking the medication. This is another illustration of how different psychiatry is from other branches of medicine. In the allopathic treatment model, symptom cessation often means the condition has in fact been cured. This is not necessarily so with the many mental/emotional disorders where “cure” is not possible yet or not necessarily due to medications. Clients suffering from depression that appears psychological in origin may take medications such as antidepressants for six months and engage in counseling at the same time. For many such clients, the medication provides a chemical window of opportunity wherein they get the energy to deal with the psychological issues related to the depression. Once they have resolved some of the psychological issues, their doctors can titrate them off the medicine. Other clients may suffer from psychological symptoms that seem to have a strong biological component (such as symptoms of Bipolar I Disorder). These clients may be facing years or a lifetime of some medication regimen and face different issues from those who need medication for only a short period.
At the other end of the spectrum is the client who stops taking the medication after a short period because she or he does not notice any effect. As we emphasize throughout this book, many of these medications may take weeks before their therapeutic effects begin. In addition, some clients who discontinue their medication do so because they do not like the side effects. Our experience is that such clients would do better to contact their prescribing professional to see if there is a different medication they may be better able to tolerate. Although mental health clinicians cannot make specific recommendations about medications, they can refer clients back to their doctors when necessary.
Patterson (1996) also noted that some clients believe their medications are not working because they have unrealistic expectations for the medication. One client we recall who was taking an anti-depressant was astonished at how sad she became at the funeral of a beloved aunt. She had a history of being overwhelmed by powerful depressive episodes and had developed a defense of warding off strong feelings, assuming that if she could do that, she could maintain emotional control. She said she sobbed throughout the funeral as if she hadn’t cried for years (and in fact she hadn’t). This client had an unrealistic expectation that the medications were akin to a vaccine against sadness. With her counselor, the client came to see her emotional expression at the funeral as a personal victory in that she expressed her true feelings and was able to grieve with loved ones but wasn’t overwhelmed by the grief. Whether this victory was the result of the therapy, the antidepressant, or both could not be differentiated, but it was one of the first signs of improvement in quality of life for this client.
Another problem (although not as common as supposed) is clients who abuse their prescription medication because they like the effects or get a “high” from the medication. Of greatest concern among the psychotropic medications are the benzodiazepines and amphetamines, which can be abused to induce an altered state of consciousness and can potentially induce dependence. Although this is a concern for a minority of clients, most clients on these medications do not abuse them and once government disinformation is sifted out, the risk is relatively minor.
Perhaps the most problematic situation is when the medication seems to work for the client but it is precisely these therapeutic effects that the client does not want. This may be the case particularly when the symptoms are pleasant or somehow reinforcing for the client. We recall one client (Jacob) who suffered from Bipolar I Disorder and who really missed the manic “highs.” When Jacob suffered from mania his “highs” eventually became incapacitating, leading him to high-risk behaviors that twice ended with his incarceration. He said that although the medication seemed to preclude the mania, it made him feel “normal.” For Jacob, “normal” was not as good as he felt in a manic phase. The client tried three times to titrate off his medication over a period of five years. Each time he relapsed within eight months. This was truly frustrating for him, because his manic episodes always ended with him incarcerated or in an inpatient treatment facility. In cases such as Jacob’s, an existential counseling approach is very helpful. Such approaches help clients develop a sense of meaning in the middle of difficult or even unacceptable existential givens (such as illness, infirmity, and mortality). John Brent’s (1998) article on time-sensitive existential treatment is an excellent synopsis of an approach that can be used with clients such as Jacob. In Jacob’s case, he had to work through the difficult reality that every time his doctor titrated him off his medication, he relapsed within one year. The existential givens for Jacob included a nervous system that seemed to require medical intervention for Jacob to be able to function in Western society.
Review Questions
- What is the difference between compliance and adherence?
- What are four different ways clients may conceptualize their symptoms?
- What are common reasons clients do not comply with medication regimens?
- What are predictors on noncompliance? What are some therapeutic ways to work through them with clients?
SECTION TWO: TALKING TO CLIENTS ABOUT MEDICATIONS: KNOW AND EDUCATE THYSELF
Learning Objectives
- Be willing to examine your own personal and countertransference issues regarding medication.
- Be able to discuss supervision issues that arise in assessing and monitoring clients taking psychotropic medications.
- Understand the important advocacy role mental health professionals play.
- Assess your own willingness to be an advocate for your client.
The variation on the Delphic motto (“Know thyself”) in the subheading for this section is another good mantra for any mental health professional in training. Your own attitudes about and past experiences with psychotropic medication can seriously affect your work with clients. It is of the utmost importance that all mental health counselors be aware of their own psychological issues with medication to preclude countertransference reactions. Recall that countertransference occurs when a client’s issue triggers unresolved issues in the therapist, which the therapist may not be aware of. If left unaddressed, these can then render the therapist less effective with the client.
One counseling student we worked with had been an excellent student and had done equally well in her internship until she got her first client being treated with mood-stabilizing medication (lithium). She felt the client should stop taking the medication because of the severe side effects and almost went so far as to say that in a session with the client. This intern, who was normally open, interested, and very present in counseling and supervision sessions, became emotionally “closed off.” In supervision, it turned out she had had a sister who suffered from schizophrenia and had committed suicide. The intern had experienced a great deal of anguish in watching the effects of the medication on her older sister and to some extent blamed the low quality of her sister’s life—and her eventual suicide—on the medication. Although the counselor’s sister had been on a different medication (haloperidol/Haldol), the issues the counselor’s client was dealing with were similar enough to trigger the counselor’s own unresolved issues related to psychotropic medication.
If your client is on medication, take a minute to check in each session with the client about therapeutic effects, side effects, and compliance. If there seem to be problems with compliance, shift the focus of the session to that. Remember, however, that the aim of counseling or psychotherapy is not to make sure your client stays on his or her medication. Clients have a legal right to refuse medication and some studies suggest counseling is the most common response to medication refusal even in inpatient settings (Carey, Jones, & O’toole, 2013). Your client is another human being who has a right to make choices about her or his life and the treatment of his or her symptoms. Many beginning therapists are so consumed with worry over their client’s compliance with a medication regimen that they cannot be present—attentive—for the client in the session. Some researchers have found that even clients with severe mental disorders can learn to assume responsibility for their medication management (Dubyna & Quinn, 1996; Mitchell, 2007).We will discuss adherence issues when children and adolescents are taking psychotropic medications in the chapter devoted to children and adolescent issues. The issues related to adherence are even more complex where children and adolescents are involved party because most psychotropic medications do not have on-label approval for pediatric use (Dean, Witham, & McGuire, 2009).
When mental health therapists are talking to clients about medication education is a critical component (American Academy of Child & Adolescent Psychiatry, 2009; Patterson, 1996). As indicated by many of the irrational thoughts about psychotropic medication just described, most people are not aware of what such medications can and cannot do for them. Patterson points out that the therapist must emphasize that these medications are treatments, not cures, and that the client ultimately must manage his or her own life. Understanding the main effects, the side effects, and how the medication is supposed to alleviate the symptoms is important knowledge for the client. Patterson also recommends, when talking to clients, using the word medications rather than drugs, because the latter term may be confused with drugs of abuse—about which very few people actually have good information, as we noted earlier in the chapter.
Ingersoll (2001) noted that the mental health clinician is in the role of “information broker,” which requires some real work. To be a good information broker, you must first be able to differentiate good information from bad information. For our purposes, good information draws from clinical case summaries, peer-reviewed literature, and one’s own clinical observations. The biggest problem with peer-reviewed literature is that it may be biased toward the medical model, for reasons we discuss later in the book such as being funded by the pharmaceutical company making the drug. Because of this bias, peer-reviewed literature should also be complemented with clinical case observations published in medical journals and newsletters on psychopharmacology. In addition, it is always important to read the sections of peer-reviewed articles that describe who funded the research. Research funded by a pharmaceutical company may be biased toward that company’s products. Obviously, to be a good information broker, you also need at least an adequate understanding of research design. This enables you to see the difference between a study that truly supports the efficacy of a drug and a study design that merely supports a particular view of a drug.
The student intern case discussed in the last section gives one example of how supervision plays an important role in dealing with clients who take psychotropic medication. In all supervision, the key is assuring quality treatment for clients. For clinicians in nonmedical fields such as counseling and psychology, supervisors are there to monitor client welfare by assuring that clinicians comply with legal and ethical standards as well as standards of good practice. An important component of supervising mental health clinicians is discussing medications that clients are taking and how the clinician is talking about these with clients. As stated earlier, there are no clear prohibitions against nonmedical mental health professionals discussing psychotropic medications with clients, and codes of ethics and standards in counseling, psychology and school psychology state that clinicians should be competent including knowledgeable about treatment options that clients may encounter. Buelow, Herbert, and Buelow (2000) note, legal problems are currently more likely to arise from mental health clinicians not learning about psychotropic medications than from discussing them. The types of supervision issues will vary depending on the mental health professional and the setting. Of the non-medical mental health professionals, psychologists have the broadest practice guidelines (depending on training) and thus will have more complex supervision issues. The American Psychological Association [APA] (2011) set forth guidelines for psychologists practicing at three points on a continuum regarding psychotropic medication. The first point is for those rare psychologists who have prescribing privileges. The second is for psychologists actively collaborating in medication decisions. The third and most common is when psychologists provide information that may be relevant to prescribing professionals. That is the practice point we focus on here as it is most common for psychologists and social workers, school psychologists, counselors, and other nonmedical mental health professionals.
What are some of the important supervision issues relevant to psychopharmacology? Berardinelli and Mostade (2003) have listed the following categories of responsibilities, which include activities for supervisors and supervisees: assessment, monitoring, and advocacy.
In the assessment phase of a counseling relationship, the mental health clinician needs to learn what current medications clients are taking, including dosage, frequency, and formulation. In addition, clinicians need to assess the client’s use of other licit or illicit recreational drugs. Fulfilling this responsibility assumes some knowledge of the categories, effects, and side effects of psychotropic medications on the part of the supervisor and the supervisee. As Ingersoll (2001) notes, this is where training in psychopharmacology becomes important, particularly for supervisors. The APA has created curricula for three levels of training in psychopharmacology, and the first level (or its curricular equivalent) (APA, 1995) should be required for supervisors of mental health professionals.
The assessment phase should include getting a signed release from the client to view copies of the file on the client kept by the prescribing professional. Many large providers like hospitals are using electronic note systems like Epic and Avatar. Each of the charts in these systems have sections on client medication but sometimes they are broken into current medications and all previous medications. Obviously it is important to know when clients started and stopped medications so you can understand what has worked and what has not for each client. Assessment may also include (with client permission) contacting the prescribing professional for consultation and to let her or him know (again, only with the client’s release) what you are treating the client for, and ask about the professional’s sense of how the medication is working for the client (along with any other questions you may have). This is an opportunity to at least establish a connection with the prescribing professional, learn about his or her prescribing style, and make a good first impression. With that in mind, you should know what symptoms the prescribing professional has prescribed the psychotropic medications to treat and be familiar with the medications prescribed. While prescribers may speak in terms of diagnoses, always try to get them to specify particular symptoms because clients with the same diagnosis can present quite differently. Supervisors will want to make sure the supervisee is following these guidelines and adequately understands the topics relevant to his or her clients at each stage of assessment.
Berardinelli and Mostade (2003) also noted that supervisors should monitor exactly how supervisees are discussing medication side effects with clients. Although it is important to make sure the client is aware of potential side effects, we must avoid leading questions that elicit complaints of side effects (e.g., “are you having headaches with this medication?”). There is clearly more art than science to this. The initial topic can be discussed with open-ended questions about how the client is feeling, whether he or she has followed the medication prescription, and how he or she thinks the medication is working. Depending on the client, opening a session with specific questions that list side effects such as “Are you experiencing any sexual side effects, headaches, dizziness, or nausea?” may not be the best strategy unless there are compelling reasons to take this approach. Some clinical judgment is necessary here. Clients who are more prone to obsessively worrying about side effects may respond to such concrete questions as a list of things they then imagine they are experiencing. However, clients who are functioning at a concrete intellectual level may need direct questions to share side effects that are occurring. Unless you feel direct questions are necessary (as in the case of clients who are concrete thinkers), you can begin asking open-ended questions to elicit the client’s thoughts about how the medication seems to be working.
Monitoring is an important component of the therapeutic relationship and supervision. Supervisors should make sure supervisees are checking in with clients at each session about medication, updating medication information as it changes, and keeping records of medication compliance as well as the client’s response to medications. The last item is particularly important, especially for clients who do not see the same prescribing professional on a regular basis or for clients who have not given the clinician permission to contact their prescribing professional. The record of client responses to medication is also important in relation to the record of what is happening with the client psychologically.
For example, in one case we treated, the client suffered from Bipolar I Disorder and seemed to show subtle signs of improvement just before the onset of manic symptoms. This happened twice, with two different medications the client was on. The first time the therapist took the shift as a signal of improvement in mood, but the second time the therapist saw it as the first sign of approaching manic symptoms. The client learned in this case the difference between mood stabilization and the onset of manic symptoms. Genuine improvement in this client appeared similar but was followed by increasing insight and unimpaired reality testing.
In another case, the client’s perceptions of how helpful the medication was correlated with how events were unfolding in her personal life. When her personal life was going the way she wanted, she felt the medication (in this case an antianxiety medication) was helping. When events in her personal life were not going well, she complained that all she got from the medication were side effects. In tracking this relationship, the issue of locus of control emerged as important in counseling. The client came to realize that she had, over a period of years, established the medication as an external locus of control and that the medication now provided a convenient target when things weren’t going well. After six months of work on this locus-of-control issue, this particular client asked her doctor to titrate her off the medication. After a year she was still functioning well without it.
Advocacy is actively supporting the client to make sure she or he is getting the best service possible. Where medication is concerned, supervisors must make sure their supervisees’ efforts at advocacy do not cross the line between support and actually recommending medication. Although mental health professionals do not recommend medications, they can ask prescribing professionals questions on the client’s behalf (e.g., “My client is taking an older antipsychotic with severe side effects. Do you think she would benefit from one of the newer antipsychotic medications?”) According to Berardinelli and Mostade (2003), advocacy issues include recognizing client needs and the particular needs of certain client populations, integrating medication issues into counseling, and knowing when to refer clients for case management and other services. Advocacy in this sense requires that supervisors and supervisees be familiar with community resources, including medication programs and trials, and programs that help clients pay the cost of medications and provide education to significant others and employers when necessary and when desired by the client.
An interesting question is whether mental health professionals should suggest to prescribing professionals that a particular client may benefit from a particular medication. The short answer is no. In the most conservative sense, in this situation the mental health clinician is assuming he or she has the same level of knowledge of psychotropic medications as the prescribing professional. Although this is possible, the most conservative interpretation of such action could be that the mental health professional is practicing medicine without a license. Obviously, cases in which mental health professionals have the proper training and legal mandate to prescribe (as in certain states and territories where psychologists have the right to prescribe psychotropic medications) do not apply here. The long answer is that because reality is complex we must look at the context of the situation and how the clinician approaches the prescribing professional. Ingersoll (2001) noted that much can be accomplished by assuming the “one down” position and approaching the prescribing professional with the attitude of requesting education. For example, if a client is prescribed carbamazepine/Tegretol for Bipolar I Disorder and still relapsing, the mental health clinician may wonder if new antipsychotics have been tried for the manic symptoms. Certainly carbamazepine/Tegretol has efficacy for some clients but if the client is relapsing the question may be worth asking. In this example the clinician may ask, “I’ve heard that some clients with this disorder take atypicals in addition to other mood stabilizing agents. How do you feel this client would respond to such a combination in treating Bipolar I symptoms?” If a clinician seriously questions the work of a medical professional, there are several possible approaches. If the work of the clinician appears to constitute malpractice, a report to the prescribing professional’s licensing board is in order. If the questions simply revolve around whether the best medication was selected for the client, the clinician can reinforce the client’s right to ask the prescribing professional questions or seek a second opinion if that is an option. We emphasize that this advocacy issue is grey and clinicians would do best to exercise conservative judgment here.
Review Questions
- What personal beliefs do you bring to the profession about psychotropic medications?
- What are key issues in assessment and monitoring for supervisors of mental health professionals who treat clients taking psychotropic medications?
- Discuss the extent to which you feel comfortable advocating for a client. If a senior clinician told a client incorrect information about a medication what would you do?
Many psychological issues arise in our clients when either psychotropic medication is recommended or taken. Clients use several strategies to avoid medication, including irrational beliefs about medications, secondary gains from symptoms, and difficulty with routines.
Multiple truths and realities govern the way clients respond to a course of psychotropic medication. Therapists need to recognize how clients accept psychotropic medications into their intrapsychic and unconscious worlds. It is helpful to talk to our clients about the strengths and limitations of both medications and conventional therapy. In addition, mental health clinicians need to know how to collaborate with medical professionals as well as how to review medication issues in supervision sessions.
SECTION THREE: ETHNO-PSYCHOPHARMACOLOGY: GROUP DIFFERENCES IN RESPONSE TO PSYCHOTROPIC AGENTS
Learning Objectives
- Be able to give a general definition of ethnopharmacotherapy and its main concerns.
- Discuss the role of sex and race in how pharmaceuticals affect people.
- Understand the effects of discrimination and oppression on people’s view of prescription drugs.
- Be able to articulate ethical concerns that arise when dealing with prescribing professionals.
Ethno-psychopharmacology, a relatively new subdiscipline of psychopharmacology, explores ethnic and racial differences in response to medications, differences that appear to be physiologically based (Ng, Lin, Singh, & Chiu, 2008). Scientists have known for years that people of different racial and ethnic backgrounds may have genuine physical differences that make them more or less sensitive to certain drugs or medications. Alcohol has always been a quintessential case in point (Westermeyer, 1989). People of Asian descent and women have less of the enzyme that breaks down alcohol (alcohol dehydrogenase). This makes these groups more susceptible to the effects of alcohol (Gordis, 2000; Julien, Advocate, & Comady, 2011). This does not mean they are more likely to develop patterns of abuse or dependence, just that they are more sensitive to the effects. If such differences exist across groups regarding alcohol, many researchers began wondering whether such differences also exist for psychotropic medication, and in fact they do. These physiological differences can also be further accentuated by cultural differences in diet; use of substances such as herbs, alcohol, and caffeine; and the extent of environmental pollutants (Bhugra & Bhui, 2001; Malik, Lake, Lawson, & Joshi, 2010). Ethno-psychopharmacology is now being viewed through the discipline of pharmacogenetics. As genomic sequencing becomes more accessible some researchers like Ng and Castle (2010) believe we will be able to link racial and ethnic genetic differences to differential responses to medications. While this is still in the future, the possibility is intriguing (Jones & Perlis, 2006).
After some stark initial findings, scientists now agree that extensive work is needed to explore sex differences in response to psychotropic medication (Jensvold, Halbreich, & Hamilton, 1996; Marazziti et al., 2013). Strong evidence shows that males and females respond differently to medication, but little research is devoted to understanding this difference. Robinson (2002) has documented that although women are the primary consumers of most types of psychotropic medication, and although sex differences appear in the absorption, metabolism, and excretion of many medications, little attention has been paid to these differences in research. This gap implies an ethical imperative for pharmaceutical companies. If they target women in direct-to-consumer advertising (Petersen, 2009), then they must conduct research supporting the safety and efficacy of these medications for women. Until such a research database is built, clinicians must advocate for clients by keeping up-to-date on the research that exists on psychotropic medications and responses of females. In addition, there are sex differences in symptom profiles. For example, women are more likely to have atypical symptoms of depression, comorbid anxiety and attempt suicide (Gorman, 2006).
Differences in absorption exist between premenopausal women and men, with premenopausal women moving material more slowly through their digestive tract. This delays peak levels and lowers blood concentrations of medications. Women also typically weigh less than men, have less total blood volume than men, and carry a higher percentage of body fat than men. For example, women may initially have low blood levels of a compound, but if the compound is stored in fat cells then levels may rise overall, eventually providing women with higher levels of the compound than men would have. The fact that women clear drugs more slowly than men means that optimal doses for males may be too high for females. Robinson (2002) notes that this may be why women experience side effects from psychotropic compounds about twice as often as men. Along these lines, Hamilton (1986) found that women taking older antipsychotic medications have higher rates of tardive dyskinesia (a disorder of abnormal, late-appearing, involuntary movement) than do men taking the same medications. In addition to these differences, women’s physiology changes through the menstrual cycle. Premenstrual changes include a slowed rate of gastric emptying and decreased gastric acid secretion. Both these changes tend to raise blood serum levels of psychotropic medication before menstruation.
It is important to know that many psychotropic medications appear to interfere with fertility. Psychotropic medications (and particularly mood stabilizers and antipsychotics) have been shown to have adverse reproductive and gynecologic effects (Talib & Alderman, 2013). If a client on psychotropic medications is trying to become pregnant, she should discuss this decision with her physician, who can help her weigh the risks. This is an area where female clients may need the support and advocacy of mental health professionals. Many clients still believe they cannot question their doctors and cannot participate in treatment decisions.
Several psychotropic medications have also been linked to teratogenesis (the development of birth defects). Obviously, if a woman is pregnant, she should, if possible, refrain from taking any psychotropic medications. Although this is not always possible, the risks to the unborn child must be weighed against potential risks to the mother should she stop taking a particular medication. In other cases medications have documented dangers to the neurodevelopmental health of the fetus (Galbally et al., 2010; Gentile, 2010). Such decisions are typically difficult. One client whom I (Ingersoll) treated in the late 1980s was taking mood-stabilizing medications that had been shown to put the fetus at risk (lithium/Lithobid, which causes a heart valve defect called Epstein’s Anomaly). She chose to go off the medication during her pregnancy, which resulted in her decompensation and the need for a more restrictive treatment setting (an inpatient facility, in this case). Although we may never know the impact of her emotional suffering (as a result of relapse related to going off medication) on her child, we do know that going off the medication decreased the child’s risk of heart malformation associated with the medication the mother was taking.
The Food and Drug Administration (FDA) requires that prescription medications that may cause harm to the developing fetus be classified according to one of five categories (A, B, C, D, X). Category A includes medications for which controlled studies in women fail to show risks to the fetus in the first trimester and the risk of harm appears low. Category B includes medications for which animal studies have not shown fetal risk but there are no controlled studies in pregnant women or for which a risk shown in animal studies was confirmed in studies with women. Category C includes medications for which either studies with animals have shown teratogenic effects or there are simply no animal or women’s studies. Category D includes medications for which there is positive evidence of human fetal risk. Such medications have warning sections in their labeling. Category D medications may still be used if the risk–benefit analysis shows that more harm may come to the mother if the medication is not used. Category X includes medications for which studies in animals or humans clearly link the medication to fetal abnormalities and the use is unacceptable (e.g., all formulations of lithium has a rating of “X”). This information is listed in the contraindications section of the label.
Robinson (2002) has summarized some of the literature on teratogenic effects (causing malformations) of particular medications. Most of these effects are due to antimanic drugs and are risks primarily in the first trimester. These are summarized in Table 4.1. Please note that this is not an exhaustive list. Although many medications have teratogenic properties, scientists are not sure about many other medications yet. One good source of information is the Pregnancy Teratogens Healthline at http://www.healthline.com/health/pregnancy/teratogens.
TABLE 4.1 Examples of Antimanic Medications and Teratogenic Risks
| Medication | Risk | Citation |
| Lithium | Ebstein’s anomaly | Altshuler, Burt, McMullen, & Hendrick, 1995 |
| Carbamazepine | Craniofacial defects Neural tube defects | Jones, Lacro, Johnson, & Adams, 1989; Rosa, 1991 |
| Valproic acid | Neural tube defects | Koren & Kennedy, 1995 |
| Antidepressants | Neonate CNS depression and urinary retention | Preston, O’Neal, & Talaga, 2002 |
© Cengage Learning®
Many states have set up their own websites dealing with teratogenic information. For example, the FDA has an informational PDF at http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf. Discussing the prospect of psychotropic medication for pregnant women, Preston, O’Neal, and Talaga (2002) comment, “It is important to remember that absolute data in this area is disturbingly incomplete” (p. 229). As noted in Chapter Three the same holds true for breast-feeding on psychotropic medication (Fortinguerra, Clavenna, & Bonati, 2009). Therefore, the mental health professional concerned with client advocacy must keep up with the literature in the area and be willing to help the client (and/or guardians) weigh the risks of particular medications.
In addition to teratogenesis (malformation of the fetus), psychotropic medications may affect the developing fetus, the newborn, the actual process of birth, and breast-fed infants. Psychotropic medications may result in behavioral problems in the child who is exposed to these drugs in utero. Finally, because pregnancy induces so many changes in a woman’s body, these changes can radically alter the action of psychotropic medications (Preston, O’Neal, & Talaga, 2002).
In addition to cultural differences in attitudes and trust toward psychotropic medication and the doctors who prescribe them, scientists are now learning that psychotropic medications affect people with different racial backgrounds in significantly different objective ways. Here is a summary of a few of the racial differences that researchers have found in physiological responses to psychotropic medications:
- Some studies have found that African Americans taking older antipsychotic medications are more likely to develop tardive dyskinesia than Caucasians taking the same medications (Glazer, Morgenstern, & Doucette, 1994; Morgenstern & Glazer, 1993). This may also be related to the fact that many studies have consistently found that African Americans are more likely to be diagnosed with severe mental disorders and receive higher doses of the medications to treat them (Netjek, 2012; Strickland, Lin, Fu, Anderson, & Zheng, 1995) or to reasons that may be related to racism. In a recent study reviewing prescription trends by racial group, Daumit and colleagues (2003) found that African Americans were still more likely to receive older antipsychotics as opposed to the newer, supposedly more effective, atypical antipsychotics. Also, African Americans are more likely to be treated with polypharmacy strategies than Caucasians (Garver et al., 2006).
- Compared with Caucasians, nearly all minority groups have lower odds of adequate antidepressant use (Quinones et al., 2014). African Americans are also far less likely to adhere to antidepressant treatment later in life than Caucasians (Kales et al., 2013). Some of this seems to be an effect of systematic oppression leading to a mistrust of mainstream medicine.
- Asians and Asian Americans report more adverse effects from antipsychotic and tricyclic medications than do Caucasians. They also show higher plasma levels than do Caucasians at the same dosage (Bond, 1990; Bowden, 1995; Pi, Gutierrez, & Gray, 1993). This evidence tends to point toward the need for lower doses for these clients.
- African Americans appear to be more sensitive to tricyclic medications than are Caucasians in terms of both therapeutic and side effects (Lin & Poland, 1995).
- There are disparities on Medicaid expenditures on psychotropic medications for maltreated children. In a sample of over 4000 children, children of color received substantially less Medicaid support for psychotropic medications (Raghavan et al., 2014). African American children received $292 less on average per year than Caucasian children and Hispanic children received $144 less per year. These findings demonstrate that policy makers need to pay more attention to the needs of children of color.
- There are also racial disparities in the monitoring of patients on chronic opioid therapy. There are disparities in prescribing habits (Tait & Chibnall, 2014) as well as in monitoring patients with African Americans being less likely to be prescribed opioid pain medication and more likely to be subjected to more drug tests than Caucasian peers. Compared to Caucasian patients, African American patients are more likely to be referred to a substance abuse specialist than a pain specialist (Hausmann, Gao, Lee, & Kwoh, 2013).
- Also, African Americans seem to have a host of different influences affecting their rates and expression of depression, compared to other racial groups in the United States (Meyers, 1993) though they are less likely to take antidepressants (Paulose-Ram, Safran, Jonas, Gu, & Orwig, 2007).
- Recall that the cytochrome P450 enzyme system governs metabolism of, among other things, psychotropic medication. The differences outlined in the following studies seem to be based on racial differences in this important enzyme system (Lawson, 1999; Lin, Poland, & Anderson, 1995; McGraw, 2012; Wood, 2001). These differences may vary for genetic and environmental reasons. Various enzymes vary dramatically across different racial groups (Lin, Poland, & Nakasaki, 1993). This same mechanism may also partly cause the increased risk of hypertensionin African Americans (Strickland et al., 1995).
In comparing data from across different societies, one confounding factor is that average daily dose of medication or minimum effective dose frequently varies from one society to the next. For example, minimum effective dosage of a medication is often higher in the United States than in other countries (Bhugra & Bhui, 2001). Also note that much research on racial group differences in adverse effects focuses on older medications (tricyclic anti-depressants, older antipsychotics) that are slowly being phased out with the arrival of newer agents with better side effect profiles. Even though newer medications ostensibly have fewer side effects, the data on older medications point to differences between groups that will likely also have implications for newer compounds. In addition, because many minorities live in lower socioeconomic brackets, they may be prescribed older psychotropic medication that is available in less expensive, generic form because the patent has expired.
What should the nonmedical mental health therapist do with this information? First, we hope this information makes clinicians better information brokers, as we mentioned earlier. For better or worse, prescribing professionals may fail to take racial/ethnic differences into account and mental health clinicians need to raise these relevant points for the well-being of the client. This is particularly true in clinic settings where prescribing professionals (doctors and psychiatrists) are so overwhelmed with work that they may only get 10 or 15 minutes with clients. Doctors report racial and ethnic differences in comfort discussing things like medication cost with the prescriber and the time limitations only exacerbate such problems (Dalawari et al., 2013). In situations like these, clinicians must be willing to advocate for their clients. Later in this chapter, we offer one model on how to collaborate with prescribing professionals. In monitoring the therapeutic and side effects of medications on their clients, therapists need to be alert to the differences we have discussed. As a starting point, Bhugra and Bhui (2001) recommend screening the items in Table 4.2 for clients receiving psychotropic medication.
TABLE 4.2 Important Cultural Dimensions Related to Psychotropic Medications
| The client’s diet |
| Any dietary restrictions |
| Relevant religious taboos |
| Alcohol, caffeine, and nicotine intake |
© Cengage Learning®
As noted, there has been little research on ethnopharmacotherapy. Although a small number of committed researchers are making important contributions in this area, the nonmedical mental health clinician must regularly review the literature, because these studies are frequently not included in books on psychotropic medications.
A FOCUS ON THE CULTURAL PERSPECTIVE
Recall that what we call the cultural perspective describes subjective, shared experience and beliefs. It is the dimension that describes phenomenological aspects of groups. In this sense, culture can refer to shared worldviews and beliefs clustering around race, ethnicity, socioeconomic status, sexual orientation, spiritual tradition, sex, gender, ability/disability, or age. Culture can also refer to shared worldviews and beliefs clustering around one’s professional identification. Thus one can speak of the culture of the pharmaceutical industry, the culture of the counseling profession, and the culture of the psychiatric profession.
Because a mental health professional’s main tool is the therapeutic encounter, the impact of culture on that encounter must be figured in. The therapeutic encounter is supposed to improve the interpersonal functioning and the subjective comfort of the client. This necessarily implies defining “normal” and “abnormal” behavior, and cultural milieu determines to a large extent whether a person’s behavior or emotional state is considered “normal” or “abnormal.” Students in the mental health professions have increasingly addressed cultural variables with regard to mental health diagnosis and treatment (Labruzza, 1997; Malik et al., 2010), but how does culture relate to psychopharmacology? There are two dimensions to this relationship: the shared beliefs of cultural groups, and group differences in response to medications. We already explored the latter through the social perspective. We now address what scientists know about those factors relating to the shared worldviews and beliefs of groups. As Lin (1996) noted, psychopharmacologists simply do not know much about how cultural or ethnic factors affect whether or not a particular medication will be helpful for a particular condition.
Shared Belief Systems Regarding Psychopharmacology: Multicultural Variables
Human beings in the 21st century are still grappling with the challenges presented by diversity in the species. For example just think of how human universals vary culture to culture. Although the human body generally has a universal structure, it is adorned and altered differently across cultures and even subcultures (witness the current increase in tattooing in U.S. culture). Although many personal developmental sequences occur across cultures, cultures label and facilitate them differently (Gardiner & Kosmitzki, 2001).
Many aspects of culture may make Western forms of mental health work challenging. Consider, for example, an Arabic student who is suffering from symptoms of depression and who comes to a college counseling center at the urging of his roommate. Also consider that for this client, sharing intimate personal information outside the family may be anathema. Further, consider that this client also may view taking psychotropic medication as a sign of weakness. True, this client shares the structures of a triune brain and the accompanying nervous system however, without understanding and attempting to accommodate this client’s cultural background, a therapist is unlikely to succeed in treatment.
The cultural perspective also provides a vehicle to explore shared worldviews that stem from a history of discrimination and oppression. Many African American clients with whom we have worked approach counseling and psychotherapy with a great deal of suspicion. Without understanding the shared worldview that underlies this suspicion, mental health professionals may misinterpret it as paranoia or resistance. There is ample justification for African Americans to mistrust mental health treatment systems. Flaherty and Meagher (1980) documented that in mental health systems, African Americans tend to receive less desirable treatments (Puyat et al., 2013). In addition, many researchers have noted that African Americans have been more likely to be hospitalized (Lawson, Hepler, Holladay, & Cuffel, 1994), involuntarily committed, and placed in restraints than members of other ethnic groups (Lawson, 1999). In addition, as Lawson (1999) explained, mental health providers are often not African American and may have views of treatment very different from the views of African Americans.
Many clients of African American and Hispanic background may share a suspicion of mental health counseling and psychotropic medication, believing that basically these interventions are tools of oppression and to be avoided. Moreover, until very recently psychotropic medication trials were conducted largely with Caucasian, male samples and then assumed to generalize to other cultural groups. Again, to interpret this as symptomatically significant paranoia only exacerbates the misunderstanding. African American resistance to participation in the mental health treatment system occurs in light of the Tuskegee study sponsored by the U.S. government in the 1930s. It is now widely known that in this study, treatment was withheld from African American men with syphilis. The study continued for some 40 years before it was ended by a newspaper exposé. The federal government finally acknowledged the study officially in the 1990s, under then-president Bill Clinton. I (Ingersoll) worked with a granddaughter of one man in the Tuskegee experiment, in a sociodramatic recreation of the devastation wrought by the study. This gave me a firsthand understanding of how “paranoia” regarding medical interventions was a healthy defense for members of this family.
A substantial body of literature supports the charge that minority clients with mental and emotional disorders have often been misdiagnosed, which has led to incorrect treatment (Lawson, 1999). Strickland et al. (1995) demonstrated that African Americans and Hispanics are overdiagnosed with schizophrenia and more likely to be given antipsychotics when such medications are not needed. Bell and Mehta (1980, 1981) made a strong case that African Americans suffering from Bipolar I Disorder (and showing excellent lithium response) were often initially diagnosed with schizophrenia and therefore given antipsychotic medication. Stratkowski, McElroy, Keck, and West (1996) have also demonstrated that African Americans with mood disorders are more likely to have psychotic symptoms associated with these disorders. Their conclusion was that this required more careful differential diagnosis so that African American males who were really suffering from Bipolar I Disorder were not mistakenly diagnosed with schizophrenia. As Lawson (1999) noted, this evidence is especially problematic because there is also evidence that African Americans are more likely to develop tardive dyskinesia in response to antipsychotic medications.
Ideally, in the first encounter with culturally different clients the counselor or prescribing professional will be aware of these issues and (if psychological contact permits) will explore them with clients who appear highly guarded or suspicious. In many cases, frank discussion of the issues is the best approach. Generally speaking, the professional should also note that stress plays an important role in shaping compliance with a medication regimen and in the patient’s response to the medication. Many culturally different people are under enormous amounts of stress including financial stress, stress related to relocation, and stress resulting from isolation when they move to a new country and leave family and community supports. Prescribing professionals need to consider the possibility of these stressors for such clients (Bhugra & Bhui, 2001).
CASE STUDY: THE CASE OF RAFAEL
Rafael, a 57-year-old married Mexican man, came to counseling at a mental health center because he complained of hearing many voices. He visited his priest, who was unable to assist him and who referred him to the mental health center. The staff psychiatrist evaluated Rafael and prescribed Loxitane (loxapine), an antipsychotic for his hallucinations and disorganized thinking. He told Rafael to take his medication daily and assigned him to an agency counselor.
Each week Rafael reported to his counselor that he took his medication, but this puzzled her, because he seemed ever more psychotic and disorganized. However, he reported compliance. Rafael became so confused and impaired that he could no longer drive to his appointments, so his wife brought him. After one very perplexing session, the counselor asked his wife if Rafael was taking his medications. She looked away and said quietly, “Only on the days he comes to see you. On all the other days he prays to the Blessed Virgin for his health with his men friends.” The counselor learned that Rafael encountered great resistance about medications from his cohort of friends, who urged him not to take his medication but to pray for sanity and health to the Blessed Virgin. So the only times he took Loxitane were on the days he had an appointment with his counselor. Fortunately his counselor was able to seek the assistance of the Latina counselor on staff and Rafael’s priest to intervene with Rafael and his wife and prevent further decompensation and possible hospitalization.
Obviously, it is an error to prescribe psychotropic medications with the assumption that all people from all cultures will receive support and understanding of the process in their homes. People from many cultures have various rules, rituals, and ideas about the danger of “pills for the mind,” and the levels of resistance are legion.
The astute reader may have a question at this point that goes something like this: “So in reality, all Rafael’s prayer did not cure his psychosis, but the Loxitane seemed to help. Doesn’t this validate the importance of the medical model intervention (medication) over the prescribed cultural cure (prayer)?” Certainly Rafael’s symptoms seemed to benefit from the medication, but that intervention needed to be complemented with the support from his prayer time with friends. Without seeing a way to integrate these two things, Rafael simply stopped taking the medication. In this case, the counselor also consulted with Rafael’s priest, who met with Rafael to discuss the difference between praying for healing and praying for a cure. When Rafael was able to engage in this dialogue, he came to understand that although his prayers to the Blessed Virgin did not produce a “cure” per se, he did receive “healing” of sorts in the form of comfort and the strength to eventually go on the medication despite the opinions of his friends. Here, the prayer and the medication served as different tools that brought about different types of healing.
Mr. Liao is 75-year-old citizen who came to the United States 50 years ago from mainland China. Currently he suffers from a very rare autoimmune disorder of the liver that is not stable with medication. He is also seriously depressed. His life partner of 40 years is trying desperately to take him to a psychiatrist for an evaluation. Mr. Liao knows that if his partner is successful it will confirm the Chinese communities’ suspicions that they are gay and they will be ostracized from their cultural group. He insists that acupuncture and Chinese herbal medicine will help him more than western antidepressants. His partner insists that he is wrong and hires a private ambulance to take Mr. Liao to the community psychiatrist. The psychiatrist evaluates him puts him on a course of citalopram and buspirone and refers him to the culturally sensitive counselor at the agency. He also refers Mr. Liao’s partner.
Questions About the Case
- What are the salient cultural concerns in this case?
- Speak to the potential conflict between western and eastern approaches to medicine.
- Discuss what happens to people in cultures where the gay and lesbian lifestyle is either forbidden by religious practice or rejected by cultural norms.
- How did the psychiatrist respond to Mr. Liao’s concerns?
A MEETING OF SUBCULTURES: COLLABORATION WITH PRESCRIBING PROFESSIONALS
Cultural variables can also be interactions between professional subcultures such as counseling and psychiatry or, more generally, between prescribing professionals and nonmedical mental health therapists. Western culture shares a belief in a hierarchy among health professionals, with doctors at the top. The mental health hierarchy has psychiatrists at the top. Neal and Calarco (1999) noted that in the past medical training always emphasized that the doctor is in charge in any team approach to treatment and that some doctors, having internalized this belief, can be quite authoritarian even when they have not studied and do not understand psychotherapeutic approaches. Although one can certainly deconstruct this, place it in nested contexts, or argue that it is a “patriarchal hangover,” it still exists as a shared belief with which nonmedical mental health clinicians must deal.
Ingersoll (2001) noted that the nonmedical therapist’s approach depends on the attitude of the prescribing professional toward psychotherapy. If a psychiatrist does not value psychotherapeutic approaches, the mental health professional may find a “one down” approach helpful. In this approach the nonmedical therapist presents him- or herself as willing to learn about medications from the prescribing professional. This approach can begin the alliance-building process between the medical and nonmedical members of a treatment team and can give the mental health professional an opportunity to practice equanimity.
At the time of this writing, there are some problematic trends that could create a larger divide between medical and nonmedical mental health professionals. First more and more people with mental health problems are going to their general practitioners rather than a psychiatrist (Olfson, Kroenke, Wang, & Blanco, 2014). Although nonmedical mental health professionals can certainly collaborate with general practitioners, they often do not have extensive training in mental health issues. They do their best to help clients alleviate symptoms with medications but may not be aware of the overdetermined nature of some disorders. Another reason for this shift may be that increasingly fewer psychiatrists are accepting new patients with noncapitated insurance, Medicaid and Medicare compared to physicians in other specializations and in general practice. Acceptance rates for all types of insurance were significantly lower for psychiatrists than physicians in other specialties and this may pose barriers to mental health service (Bishop, Keyhani, & Pincus, 2014).
In collaborating with prescribing professionals, mental health clinicians can benefit from a judicious combination of equanimity and what we would colloquially call “people skills.” Centuries ago, Buddhism introduced equanimity as one of the four sublime states (the other three being love, compassion, and sympathetic joy). Equanimity is the practice of approaching an interaction with respect and caring while remaining unattached to how the interaction unfolds and how you are treated (Gunaratana, 2002). Although this approach can be challenging, it is possible. Reflecting on the good that could come to the client you share with the prescribing professional can be enough to foster the equanimity you need. Also, if a particular prescribing professional thinks poorly of mental health professionals in general, you are not likely to change his or her mind in one interaction.
Next, use good interpersonal skills. This is obvious, but worth noting because people can forget these skills in the press of a crisis or busy day. Most prescribing professionals are equally busy and well intentioned. Reminding ourselves of this can serve as a cue to enter the interaction in a courteous manner regardless of how frantic the setting or your mind-set may be. Ideally both professionals approach the relationship with some mutual respect, because this inevitably helps the client, who would likely be disadvantaged by friction between providers. As Balon (1999) points out, good collaboration is important because the team approach is an economic necessity and likely to remain so.
How the collaboration is set up is important. In agency work, therapists do not have much choice about which doctors they are going to work with. In private practice there is more choice, depending on which practitioner can be persuaded to collaborate. Evidence is growing that a good therapist–prescriber relationship is correlated with more positive client outcomes (Neal & Calarco, 1999). Next we discuss some important elements of collaboration.
Conditions of the Relationship
Each professional should know the credentials of all other collaborating professionals as well as the areas of specialization and populations each party has worked with. As noted, mental health professionals want to know the medical practitioner’s attitude toward counseling and psychotherapy, because a negative attitude can diffuse the therapeutic alliance. Also, it is important to define the role (if any) the mental health clinician plays in giving feedback to the medical practitioner (and whether the professional will welcome or resist feedback).
Regardless of whom the client met first (doctor or mental health professional), the recommendation for either therapy or medication presupposes that the client’s case will be fully disclosed to the prescriber and that appropriate documentation and releases must be obtained. This is even more important since the enactment of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
At times, clients either decompensate in reaction to a psychotropic medication or quickly develop adverse effects to the medications. The treating medical professional may be either oblivious to the changes or may insist that the medications are correct for this client. To prepare for such conditions, the mental health clinician must develop assertive and appropriate confrontation skills to advocate well for the client.
Transference and Countertransference Issues
Finally, transference and countertransference issues must be addressed when they arise, and a vehicle must be set in place for addressing them. To avoid triangulation, which will likely undermine the treatment plan, each professional must be aware of his or her transference and countertransference relationships with the client and with each other. Whenever a third party is brought to the relationship, the impact on the client must be assessed.
SECTION FOUR: SOCIAL INSTITUTIONS AND THEIR IMPACT ON PSYCHOTROPIC MEDICATIONS
Learning Objectives
- Be able to discuss the supposed risks and benefits of direct-to-consumer (DTC) advertising of psychotropic medications.
- Understand how financial conflicts of interest in pharmaceutical research can harm your clients.
- Understand the five schedules used for categorizing drugs by the Drug Enforcement Agency (DEA).
Although many social institutions could be examined here, we focus on the FDA and on pharmaceutical companies in general, because they have the most profound impact on psychotropic medications. It would be nice if mental health professionals could operate in a vacuum unaware of what the FDA and pharmaceutical companies were doing, but responsible advocacy requires at least a general understanding of these two forces.
The Food and Drug Administration
The FDA is the federal U.S. government agency charged with overseeing drug testing and development, approving new drugs and compounds, and monitoring approved drugs and compounds. Currently, the FDA has nine different centers or offices, performing a variety of functions. In the early 20th century, the FDA was part of the U.S. Department of Agriculture. As recently as 1929, consumers got all but 5% of their medications directly from pharmacists, with no prescription from doctors necessary (Temin, 1980). This changed with the passage of the 1938 Food, Drug, and Cosmetic Act, which was amended in 1962. The FDA has historically addressed three distinct (and at times antithetical) risks:
- The risk of overpaying for a drug (because of diluted form or low quality)
- The risk of an adverse drug reaction
- The risk of failing to recover after taking a drug as prescribed
These risks receive different emphasis at different times in history, but the results have largely been of the “good news/bad news” type (Temin, 1980). The good news is that although regulation has not eradicated risk, it has decreased some risks by requiring standards of dosage, potency, and proof of efficacy. The bad news is that the result has been to further remove the power of choice from the consumer and from the prescribing professional. These results take on a surreal quality today, when, as psychologist Robert Anton Wilson (2002) noted, there is no “war on drugs,” only a war on some drugs. Although tens of thousands of citizens are denied access to medical marijuana because it is allegedly “addictive,” millions are prescribed legal antidepressants that are clearly “addictive” and that in many studies perform no better than placebo.
Review Questions
- What is ethnopharmacotherapy and what concerns does it try to address?
- What are some differences in response to medications that have been noted across the sexes and persons of different races?
- How can a history of discrimination and oppression affect peoples’ views of psychotropic medication?
- What is the best strategy for approaching prescribing professionals with questions?
- What confidentiality issues can arise when consulting with prescribing professionals?
Pharmacoeconomics is an interdisciplinary field where clinical outcomes overlap with health economics (Makhinova & Rascati, 2013). It began in the late 20th century as research on the economic evaluation of pharmaceutical products. Most importantly, it was to help clinicians make choices about new pharmaceutical products and helping clients get access to new medication (Schulman & Linas, 1997). Because of the economic pressure on health care systems worldwide this has developed into a thriving subdiscipline in schools of pharmacy that grant PhDs in Pharmacoeconomics (Slejko, Libby, Nair, Valuck, & Campbell, 2013). Ultimately we want to know if newer treatments that cost more are more effective. As in the case of antidepressants, it seems that they all have an efficacy hovering around 50% and newer ones do not noticeably outperform older ones. Another variable that Pharmacoeconomics must include is the power of pharmaceutical companies.
The Power of Pharmaceutical Companies
Drug companies have enormous power in all Western economies, and their power is also growing in Eastern economies. They were among the few companies to survive the Great Depression with little negative impact (Healy, 1997). Because they have enormous economic power, they also have important responsibilities once a given drug is released and important ethical considerations regarding their relationships with medical schools and other researchers (Schowalter, 2008). In many schools, Human Research Ethics Committees are reluctant to regulate potential conflicts of interest between researchers and pharmaceutical sponsors (Newcombe & Kerridge, 2007). In a survey of U.S. medical schools, only a minority of them had comprehensive conflict of interest policies (Chimos, Evarts, Littlehale, & Rothman, 2013; Chimos, Patterson, Raveis, & Rothman, 2011). The problem is not confined to the United States. In a Canadian study on conflict of interest parameters, researchers concluded only about 23% of schools polled had strong conflict of interest policies (Canadian Medical Association, 2013). Brubaker (2012) summarized conflicts of interest in three elements:
- Main Interest: Promoting and protecting the integrity of research, patient safety and the quality of medical education.
- Secondary Interests: Financial gain and desire for professional advancement.
- The conflict itself wherein the main interests are sacrificed in pursuit of the secondary interests.
Brubaker (2012) suggests that all disclosures should be mandatory and should be labeled so that there is no doubt that they are mandatory. She feels that professional associations and licensure boards are well-suited to enforce such changes. Certainly changes in medical education can have an impact. Epstein, Busch, Busch, Asch, and Barry (2013) examined psychiatric residents’ prescribing of antidepressants before and after a mandatory conflict of interest training. The residents who had the training were significantly less likely to prescribe the most heavily promoted antidepressants. Reviewing similar studies, Korn and Carlat (2013) conclude that strongly enforced conflict of interest policies do affect prescribing behavior.
Pharmaceutical Company-Sponsored Research
A problem recently explored in medical journals concerns pharmaceutical companies contracting with medical colleges to conduct research on company compounds. Researchers have raised the problems of conflict of interest (Boyd & Bero, 2000), publication bias (Rivara & Cummings, 2002) and what appear to be influences in effect size (Djulbegovic et al., 2000). Djulbegovic and colleagues found that industry sponsored studies were far more statistically likely to have higher quality scores than government funded studies. Although these specific areas are indeed problematic, recently the focus has shifted to overall bias in industry-sponsored research. The bias includes the sponsor’s role in the study design, investigators’ access to data, and control over publication (Schulman et al., 2002). The conflict-of-interest biases were addressed by the Association of American Medical Colleges guidelines on the management of financial interests related to biomedical research (Task Force on Financial Conflicts of Interest in Clinical Research, 2001). The International Committee of Medical Journal Editors (ICMJE) also revised guidelines requiring full disclosure of the sponsor’s role in the research as well as requiring that investigators be independent of the sponsor, be fully accountable for the study design, have access to all study data, and have control of all editorial and publication decisions (International Committee of Medical Journal Editors [ICMJE], 2001). Recently, the ICMJE (which includes editors from the New England Journal of Medicine and JAMA, the Journal of the American Medical Association) adopted a policy that requires studies on medications be listed on a public registry before enrollment of human subjects. The committee felt this would give the public access to many of the studies with negative findings that pharmaceutical companies frequently keep private. This policy was adopted in the wake of unpublished data linking some antidepressants with suicidal behavior in children (Tanner, 2004).
Although these seem reasonable guidelines to safeguard the research process, the question remains, are the guidelines adhered to? In a national study of U.S. medical school agreements to conduct research for pharmaceutical companies, Schulman et al. (2002) found that the ICMJE guidelines were rarely followed. The authors gathered results from 108 of 122 medical colleges. The median number of site agreements per college per year was 103. The researchers found that agreements between pharmaceutical companies and medical colleges rarely required an independent committee or monitoring board as a condition of the agreement. Agreements rarely addressed collection or monitoring of data, or analysis and interpretation of results. Only in 17 cases of 108 did institutional review boards routinely review agreements. In addition, most colleges got low compliance scores for access to data and power over publishing results. The authors conclude, “A reevaluation of the process of contracting for clinical research is urgently needed” (p. 1340).
Nonmedical mental health clinicians may wonder what this has to do with them. The short answer is that an overview of the influence of pharmaceutical companies seems to call into question how much clinicians can rely on published research to give a sense of the efficacy and safety of psychotropic medications. It is also important for client advocates to think critically about prescription medications. Although pharmaceutical companies certainly have improved the quality of life for many, they are among the wealthiest companies in the United States and, as such, have enormous political influence. This requires oversight and monitoring by the government, consumer groups, and those who advocate for consumers—including mental health clinicians. Those who have power rarely give it up willingly, so it must be monitored by those under its influence. However, having too much government regulation may also block a person who wants/needs a particular compound from getting it.
Pharmaceutical Companies and Direct-to-Consumer Advertising
The economic power of the pharmaceutical industry is enhanced by its direct link to the consumer through advertising. Pharmaceutical companies are now allowed to advertise directly to consumers via print and media campaigns for medications. This is called direct-to-consumer (DTC) advertising or sometimes direct-to-consumer-pharmaceutical advertising (DTCPA). DTC advertising can be defined as efforts by pharmaceutical companies to promote prescription medication directly to consumers (patients) rather than doctors. DTC advertising is now the most prominent sort of health information that the public encounters (Ventola, 2011). It is only legal in the United States and New Zealand although Canada allows ads that mention either the product or its use but not both. Pharmaceutical companies have put a major effort into overturning DTC bans in Canada and the European Union (Ventola, 2011).
Before the ban on such advertising was lifted in the late 1980s, pharmaceutical companies spent approximately $12 million a year on drug advertisements, mostly aimed at prescribing professionals. Since DTC advertising has been allowed, companies spent $600 million on such advertising in 1996 and $900 million in 1998 (Hollon, 1999). Further loosening of restrictions in 1997 (especially regarding television ads) led to DTC advertising to be a multi-billion dollar industry with $4.51 billion being spent between 2008 and 2009 (Avery, Eisenberg, & Simon, 2012). Antidepressants are the second largest prescribed drug class in the United States and DTC ads have significant impact on the sales of antidepressants (Avery, Eisenberg, & Simon, 2012a). Companies are currently including psychotropic compounds for children in their marketing strategies for those few drugs (such as stimulants) that do carry FDA on-label approval.
Advocates of the DTC movement note that it can be an excellent way of providing educational information to the consumer including new drug treatments and awareness of symptoms (Hollon, 1999; Womack, 2013). Critics note the considerable profit margins correlated with advertising and suggest that, without medical oversight, whatever quality information is available will get lost in the race for profits (Hollon, 1999; Womack, 2013). In a recent analysis Avery, Eisenberg, and Simon (2012b) concluded that less attention in ads is given to risks of medications, ad content favors communication of benefits though they feel the balance is getting better.
Many advertisements for psychotropic medication make a point of stating that the psychological disorder (whichever is being targeted in the ad) is a “medical illness,” thus seeking to capitalize on the association with allopathic models for treating disease processes such as bacterial infections. Taken literally, this could severely affect mental health professionals. Imagine if the relevant regulatory bodies agreed that mental/emotional disorders were strictly “medical illnesses.” If this stricture were taken to the logical extreme, we could all be accused of practicing medicine without a license. DTC advertising is correlated with significantly larger profits. In the year 2000, the most advertised drugs saw increases in sales of 32% (Express Scripts, 2001). This trend, for better or worse, will certainly drive pharmaceutical companies to get FDA on-label approval for as-yet-untapped markets such as children and adolescents. As noted these take time. See the FDA approval process detailed in Table 4.3. While the debate on DTC advertising rages on (Ross & Kravitz, 2013), studies increasingly conclude it can lead to needless and potentially harmful overprescribing (Niederdeppe, Byrne, Avery, & Cantor, 2013).
The Subculture of the Pharmaceutical Industry
A culture is a group of people with a shared belief system or worldview, and each pharmaceutical company, as well as the industry as a whole, develops its own subculture. With the repeal of laws banning DTC advertising, pharmaceutical companies have more opportunities than ever to portray themselves to the public. In many commercials, pharmaceutical companies portray themselves in almost heroic fashion as being on the front lines of battle against some disease or on the brink of some discovery that will revolutionize medicine. At the same time, critics have had more opportunities than ever to point to the tactics underlying DTC advertising and to what they feel are misrepresentations of facts about medicine and medical science. As MacDonald (2001) pointed out, such ads are more designed to sell the medications in question than to inform the public. Although both perspectives may have merits, the truth probably lies somewhere in the middle. The culture of pharmaceutical companies exists in the semi-free-market economy (one dynamic that prevents a purely free-market system is the granting of huge government subsidies to large corporations), and the bottom line is that the companies must make profits. How much profit they should make has been a point of contention since Estes Kefauver opened his hearings on the drug industry in the late 1950s.
TABLE 4.3 Phases of the FDA Approval Process
| Preclinical research and development using animal models (can last up to six years). |
| Filing and approval of Investigational New Drug Application. |
| After approval of Investigational New Drug Application, FDA has 30 days to decide if clinical trials will be allowed. |
| Phase 1: If the drug is approved, clinical trials begin with a small number of healthy volunteers (lasts about 18 months). |
| Phase 2: Phase 2 clinical trials include patients who might benefit from the drug (lasts about two years). |
| Phase 3: Phase 3 clinical trials proceed with a large number of patients where the drug is tested against placebo. This phase must yield at least two “pivotal” trials with statistically significant results. Trials typically last 4 to 6 weeks (entire phase requires about 18 months). |
| When Phase 3 is over, the company files a New Drug Application summarizing data. |
| The FDA then has 24 months to approve or not. |
| If the New Drug Application summarizing data is approved, the FDA then must approve the label for the drug. |
| Finally, after approval of label and after marketing begins, the drug must be monitored in the market for newly discovered problems. |
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The culture of pharmaceutical companies cannot be divorced from the fact that they are among the wealthiest and most powerful industries in the world. Critics such as Ariana Huffington (2000) note that the prescription drug industry cloaks its “self-interest in language about pharmaceutical research and the public good” (p. 169). Huffington chronicled the efforts of several pharmaceutical companies to stop production of inexpensive AIDS drugs in South Africa. The companies wanted South Africans to pay U.S. prices for the drugs, but the U.S. price of $500 a week equaled the annual per capita income of sub Saharan Africa. Three companies sued South Africa to keep the South African law allowing access to these medications from taking effect. The companies also lobbied for severe trade sanctions against South Africa. Huffington raises serious questions about the ethics of an industry that makes among the largest profits in the world, neglecting research on lethal diseases in favor of developing yet more antidepressant medications or pharmaceuticals for pets (pet pharmaceuticals gross about $1 billion annually in the United States).
On the other side of the argument, commentator Thomas Sowell (2002) notes that the costs of medications reflect years of research and development, as we have seen in reviewing the FDA process. He also notes that although other countries have scientists and facilities capable of developing new medicines, economic and political situations in those countries discourage companies from investing as hugely as U.S. pharmaceutical companies do in developing new products. Sowell makes the case that the U.S. patent laws allow the company to recoup its investment and make a profit. Other countries often ignore or evade U.S. patent laws to get medications more cheaply. He also adds that the United States produces a disproportionate share of the life-saving drugs in the world.
When we ask doctors what they feel the main impact of DTC advertising is, they say it increases the numbers of patients who come in asking for some medication they saw advertised. These doctors also add that rarely do the clients fully understand what the medication can actually do for them and what the possible adverse effects are. Mental health clinicians therefore need to be aware of the connection between the way pharmaceutical companies portray themselves and those companies’ economic interests, because clinicians must bridge the information gap for their clients. Students in mental health areas may feel it is hard enough keeping track of all the new medications, let alone understanding other integrative variables such as the FDA and the culture of the pharmaceutical companies. But education that is only utilitarian in nature is incomplete and potentially dangerous. The clients whom mental health professionals are pledged to serve deserve clinicians who can help them navigate complex reality by weighing the claims made for any medication in the given social and cultural environment.
The federal Drug Enforcement Agency (DEA) is another agency that has enormous power in the United States. Reports conflict regarding the extent to which the DEA uses this power wisely, the extent to which it abuses this power (see, e.g., Szasz, 1992), and the extent to which it actually violates civil rights (Wilson, 2002). The DEA is in charge of defining and enforcing the federal drug schedules, Schedule I through Schedule V. We discuss these categories because it is important to understand that these drug categories are set up for law enforcement purposes rather than pharmacological clarity. The closer to Schedule I, the more closely monitored the drug. In many instances, the DEA guidelines refer to substances by names that are pharmacologically incorrect (e.g., calling marijuana or LSD “narcotics”). In addition, Schedule I drugs supposedly have no medical benefit, but this is often debated, as in the case of medical marijuana.
TABLE 4.4 Summary of Drug Enforcement Agency Drug Schedules
| Schedule | Drugs Defined as Having … | Examples |
| I | A high potential for abuse and no accepted medical use | Marijuana, heroin, mescaline |
| II | High abuse potential and liability for dependence. Prescriptions cannot be phoned in or renewed | Morphine, amphetamine |
| III | Some potential for abuse but less than drugs in the first two categories | Some stimulants and CNS depressants; lower-dose opioids |
| IV | Lower potential for abuse than those in Schedules I to III | Valium, antidepressants |
| V | The lowest potential for abuse | Drugs that contain small amounts of narcotics for antidiarrheal purposes |
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Table 4.4 summarizes the five drug schedules. Although very few psychotropic medications described here are in the first two schedules, a few, such as methylphenidate (Ritalin), are on Schedule II. Readers can review the relevant laws and drug schedules on the DEA website at www.usdoj.gov/dea/.
Review Questions
- What are the supposed risks and benefits of DTC advertising?
- How could a conflict of financial interest in a study on a particular medication, actually harm your client if they are taking that medication?
- List and describe the five federal drug schedules. What are the weaknesses of this system?
We have covered a broad spectrum of issues in this chapter that are not normally addressed in books on psychopharmacology, yet all can have profound effects on clients. The primary activity that unites the diverse elements covered here is advocacy. Different professionals approach advocacy differently. Some mental health professionals such as counselors and social workers give a great deal of attention to client advocacy in their training and enter the field expecting to advocate for their clients in a variety of ways. Others, such as psychiatrists, may not really reflect on advocacy much while training but may develop a passionate commitment to it in the field. Moreover, different treatment settings deal with advocacy in different ways. We authors have both worked in agencies that used a treatment team approach, where the division of labor included advocacy in the job descriptions of some team members but not all. However advocacy issues are approached, it is important that the material introduced in this chapter be considered, because, as noted earlier in this chapter, the stakes for the client are very high.
Many readers who previewed this material told us it was easy to feel overwhelmed by the enormity and number of issues to consider. Here are some suggestions on ways that counselors and other mental health therapists can begin to integrate the issues in their practice:
- Consider practicing Integral diagnosis of the type suggested by Ingersoll (2002). This source gives a framework for evaluating clients with respect to social and cultural variables in addition to the standard five-axis DSMdiagnosis. This complementary model to standard DSMdiagnosis requires that clinicians review physical, behavioral, psychological, cultural, and social factors relevant to the client. In addition, before a diagnosis is made, the model requires that clinicians consider relevant lines of development in the client’s case.
- Talk to your clients about the issues raised in this chapter and get their perspectives. Often clients know much more about their conflicts and cultural mores than you do and can teach you about their perspectives. Asking your clients to teach you about their culture can be rewarding and also contribute to the therapeutic process.
- Address cultural and social issues in your supervision, or form a special supervision group around cultural and social issues.
- Whether you work in private practice or at an agency, consider developing a website of peer-reviewed journal articles on topics such as ethnopharmacotherapy. If you have a supervision group, perhaps everyone could commit to reviewing one article per month and posting the review or abstract with the full reference on the website.
- As an exercise in professional development, have staff consider a case with and without the cultural/social variables and then discuss how adding these variables to the case summary may enrich treatment possibilities.
- Keep an anonymous file in Excel or some other database program for your clients on medication. List diagnosis, medication, dosage, race, gender, age, and ethnicity if known. If you work in an agency where you may see hundreds of clients per year, such records can reveal interesting patterns.
Perhaps more than any other, this chapter illustrates how an integrative view of psychopharmacology expands the things we consider. Although generations of psychotropic medications were tested on Caucasian adult males, only recently has the subdiscipline of ethnopharmacotherapy questioned the legitimacy of generalizing from such studies to people of different sexes, races, and ethnic backgrounds. Further, mental health clinicians need to understand the cultures that their clients identify with so that they can better understand how culture may impact the way a client reacts to the idea of taking a psychotropic medication.
Although culture, sex, race, and ethnicity are important factors to consider in psychopharmacology, the impact and power of social institutions must also be considered. Institutions such as the FDA, the DEA, and the pharmaceutical industry hold enormous power that must be held accountable to checks and balances. Along the lines of culture and the impact of social institutions on clients, mental health clinicians must be prepared to advocate for clients when necessary.
- When recommending to female clients that they be evaluated for psychotropic medication, several unique issues and concerns arise. Discuss in detail these problems, and develop a strategy of how you will address them.
- How do you perceive the FDA and the pharmaceutical industry to be relating to clients who take psychotropic medications? Give examples.
- How might you try to influence outcomes relevant to the FDA or pharmaceutical companies that concern you?
- Do you support DTC advertising? Why or why not?
- Generally discuss your perspective on free-market economies and whether or not indigent clients should have access to expensive medications. How do you support your views? If you support both free-market economic theory and access to medical treatment for the poor, how do you reconcile these two positions?
- Are there any psychotropic prescription medications that you think should be over the counter? Explain your rationale.
- From your personal or professional experience and the examples cited in this chapter, develop a strategy for talking with a client from a culture other than your own about taking psychotropic medication.
- How would you deal with a Mexican man who refused medication because he believes his symptoms are a message from God telling him that he is one of the chosen few?
