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Abstract and Introduction

Abstract

The agreement of practicing psychiatrists with medication experts regarding how psychotropic drugs should be used to

treat behavioral and psychiatric problems in patients with mental retardation was studied.

The medication survey used in developing guidelines on the treatment of behavioral and psychiatric problems in mental

retardation was sent to 85 psychiatrists who had been identified as caring for the mentally retarded in the Texas public

mental health system. The comparison of these practitioners with the medication experts included first-line and second-

line treatment choices. Survey analysis was based on using 95% confidence intervals (CIs) to determine the type of

rating. If the 95% CIs for the practitioners' responses overlapped the 95% CIs for experts, the two groups were judged

to be in agreement. Thirty-seven practitioners (43.5%) completed and returned the survey. Few differences between

the practitioners and the medication experts were found with respect to treatments for specific mental-illness

diagnoses. However, the practitioners rated venlafaxine and mirtazapine higher than the medication experts. Lithium

augmentation of therapy with selective serotonin-reuptake inhibitors for non-psychotic depression was rated first-line by

the practitioners and second-line by the medication experts.

Practicing psychiatrists and medication experts generally agreed about the use of psychotropic drugs for mental illness

in patients with mental retardation.

Introduction

Most believe that "mental retardation" refers specifically to a developmental disorder characterized by a deficit in

general intellectual and adaptive functioning. The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

(DSM-IV) describes mentally retarded individuals as having "an IQ of approximately 70 or below" and limitations in at

least two of the following skill areas: communication, self-care, home living, social and interpersonal skills, use of

community resources, self-direction, functional academic skills, work, leisure, health, and safety.[1] To be classified as

mentally retarded, a person must show intellectual impairment before the age of 18 years. In earlier decades, many

incorrectly believed that mentally retarded people do not have the psychological processes necessary to foster the

onset of mental illness.[2] In fact, people with mental retardation can develop the same mental disorders as individuals

with normal intellectual functioning, and the prevalence of these comorbid conditions in the mentally retarded is

increasing.[3]

A number of studies have been conducted to determine the prevalence of mental illness among the mentally retarded;

most of these focused on institutionalized rather than community-based patients. Singh et al.[4] reviewed prevalence

studies conducted in the late 1970s and early 1980s and concluded that (1) 8-10% of individuals with mental

retardation have a severe mental disorder requiring treatment, (2) about 50% of institutionalized patients with mental

retardation are likely to have at least one mental disorder, (3) about 60% of mentally retarded adults in institutions have

at least one severe or minor mental disorder, (4) 20-30% of mentally retarded children in institutions have a mental

disorder, and (5) 20-35% of mentally retarded children in the community have a diagnosable mental disorder. In

addition, mental illness is four to five times as frequent in the mentally retarded as in the general population.[1] Mentally

From American Journal of Health-System Pharmacy

Practitioner Versus Medication-Expert Opinion on PsychiatricPharmacotherapy of Mentally Retarded Patients with Mental

DisordersNick C. Patel, M. Lynn Crismon, A. John Rush, and Allen Frances

Published: 10/01/2001

Page 1 of 8Practitioner Versus Medication-Expert Opinion (printer-friendly)

10/28/2009http://www.medscape.com/viewarticle/407003_print


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retarded people show the full range of psychiatric disorders, including most frequently schizophrenia, adjustment

disorders, personality disorders, and anxiety disorders.[5]

The increased prevalence of co-morbid conditions in mentally retarded people is associated with an increased use of

psychotropic medications. Spreat et al.[6] reported that 22% of mentally retarded adults were prescribed antipsychotics;

9.3%, anxiolytics; and 5.9%, antidepressants. Pharmacologic treatment is indicated to suppress the abnormal thought

processes and behavior associated with psychotic disorders and to treat the morbidity associated with depression and

other mood disorders. Aggression, stereotypy, hyperactivity, and self-injurious behavior are relatively commonsymptoms and can result in harm to the mentally retarded patient, other patients, and the caregiver. Thus, all of these

symptoms indicate a need for guidelines regarding the appropriate use of psychotropic medications in individuals with

mental retardation. We studied the extent to which practicing psychiatrists agreed with a set of such guidelines.

Background

The Expert Consensus Guideline Series is a series of practical clinical guidelines for treating major psychiatric

disorders: schizophrenia, obsessive-compulsive disorder, bi-polar disorder, posttraumatic stress disorder, agitation in

older persons with dementia, and psychiatric and behavioral problems in mental retardation. [7-12] Each set of

guidelines is based on a survey of expert opinion and provides various strategies for treatment. The survey itself is

based on evidence from the scientific and professional literature and is constructed by an editorial board consisting ofexperts in the discipline being surveyed and in scientific methodology. The main purpose of the series is to aid in the

decision-making of physicians, pharmacists, and other health care providers when confronted with these psychiatric

disorders.

There is a great need for clinical guidelines on the pharmacotherapy of mental illness in the mentally retarded.

Research and experience are lacking in this specific field. With the emergence of new psychotropic medications, the

confusion only increases. The "Expert Consensus Guideline Series: Treatment of Psychiatric and Behavioral Problems

in Mental Retardation" (hereafter called PBPMR guidelines) provides practitioners with appropriate clinical guidelines

and algorithms for the treatment of mental illness in the mentally retarded.[12]

The Texas Department of Mental Health and Mental Retardation (TXMHMR) operates 11 regional state schools and

contracts for out-patient care through 42 community centers statewide. The state schools are intermediate carefacilities for the mentally retarded, and patients' medical needs are placed in the hands of general and family practice

physicians. Psychiatrists are consulted when a mentally retarded patient manifests a psychiatric disorder or behavioral

disturbance. In the community center setting, mentally retarded clients receive a variety of services intended to improve

their adaptive functioning, and they are seen by a psychiatrist only if a psychiatric disorder or behavioral problem

occurs. Although behavioral programs are used as interventions to stabilize pathological behavior, pharmacologic

treatment may be necessary. This is largely agreed upon if a patient's symptoms meet DSM-IV criteria for a given

disorder. Even then, there are difficulties with respect to patient assessment and monitoring, and no uniform guidelines

previously existed regarding the preferred pharmacologic approach. The situation is even more difficult for patients with

symptoms and behavior that interfere with daily functioning but do not meet DSM-IV criteria for a psychiatric disorder.

Until the publication of the PBPMR guidelines, there was no clear consensus on the best methods for patient

assessment, when to use medications, and the preferred medication strategies. Our study examined how closelyTXMHMR psychiatrists agreed with the PBPMR guidelines.

Methods

PBPMR guidelines

The editors of the PBPMR guidelines first created a skeleton document based on the standard literature to identify key

decision points in the everyday treatment of behavioral and psychiatric problems in mental retardation.[12] They

highlighted points on which the literature was indefinite and then developed a written questionnaire concerning these




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treatment issues. The questionnaire used a 9-point scale slightly modified from a survey format developed by the

RAND Corporation for ascertaining expert consensus. Scores in the range of 7-9 were used to indicate the degree of

appropriateness; 4-6, the degree of equivocal opinion; and 1-3, the degree of inappropriateness. Anchor points were

also provided to further distinguish the 9-point rating scale.[13,14] The experts were asked not to consider cost when

making their ratings.

The editors asked questions about 40 clinical situations. [12] The questionnaire was sent in the spring of 1999 to 51

leading U.S. experts on pharmacotherapy of mental illness in mental retardation, who were identified from recentresearch publications, recipients of research grants, presenters at the Nisonger International Consensus Conference,

and College of Psychiatric and Neurologic Pharmacists members.

In analyzing the survey results, the editors first calculated the mean, standard deviation, and 95% confidence interval

(CI) for each item. The 95% CI is a statistically calculated range that tells the reader that, if the survey were repeated

with a similar group of experts, there is a 95% chance the mean score would fall within that range.[15] The editors

designated a rating of first-line, second-line, or third-line treatments for each item for which there was consensus. This

rating was determined by the category in which the 95% CI of its mean score fell.

First-line treatments were those strategies the expert panel believed were usually appropriate as initial treatments for a

given situation. "Treatment of choice," when it appeared, was an especially strong first-line recommendation (having

been rated a 9 by at least half the experts). In choosing among several first-line recommendations, or in deciding

whether to use a first-line treatment at all, practitioners should consider the overall clinical situation, including the

patient's prior response to treatment, adverse effects, general medical problems, and patient preferences.

Second-line treatments were reasonable choices for patients who could not tolerate or did not respond to the first-line

choices. Alternatively, practitioners could select a second-line choice as initial treatment if the first-line options were

deemed unsuitable for a particular patient.

For some questions, second-line ratings dominated, especially when the experts did not reach any consensus on first-

line options. In such cases, to differentiate within the group, the editors labeled items whose 95% CIs overlapped those

of the first-line category as "high second-line."

Third-line treatments were usually inappropriate or were used only when preferred alternatives were not effective.

For each item in the survey, the editors used a chi-square test to determine whether the experts' distribution of

responses differed from a chance distribution and to find some items for which there was no convergence of expert

opinion.

After survey analysis and assignment of ratings, the experts' recommendations were translated into clinical guidelines.

TXMHMR Survey

The survey used in developing the PBPMR guidelines was sent in the fall of 1999 to psychiatric consultants at the

TXMHMR state schools and to psychiatrists identified by their medical directors as spending a significant amount of

their time treating mentally retarded clients with mental disorders in community centers. A $75 honorarium was paid to

the psychiatrists for completing and returning the survey.

Survey analyses and ratings were conducted in the same manner as the PBPMR guidelines and then compared with

those guidelines.

Comparison of PBPMR guideline experts with TXMHMR practitioners

Results from the PBPMR guideline survey and the TXMHMR survey were compared by using the following approach.

First-line treatment choices and high second-line choices in the PBPMR guideline survey were compared with




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responses to the same item from the TXMHMR practitioner survey. If the 95% CIs for the responses of the TXMHMR

practitioners (hereafter called the practitioners) overlapped with those of the PBPMR guideline experts (hereafter called

the medication experts), the responses were judged to be in agreement.

Results

Thirty-seven (43.5%) of 85 practitioners completed and returned the medication survey. The responding practitioners

ranged in age from 36 to 74 years (mean S.D., 53.2 9.1 years), and 83% were men. All 37 practitioners specializedin psychiatry, with 18.3 9.8 years having passed since terminal training. Seventy-one percent were board-certified in

psychiatry. Their practice with mentally retarded patients was 20.0% 36.3% inpatient and 63.0% 42.3% outpatient.

Agreement between practitioners and medication experts

Practitioners and medication experts generally agreed regarding the preferred pharmacologic treatments for specific

DSM-IV diagnoses and target symptoms in patients not meeting criteria for a DSM-IV diagnosis. Valproate was

considered the treatment of choice for patients diagnosed with bipolar disorder, manic episode. Both medication

experts and practitioners rated newer atypical antipsychotics as treatments of choice for schizophrenic patients who

are compliant with oral medications. Selective serotonin-reuptake inhibitors (SSRIs) were the treatments of choice for

obsessive-compulsive disorder and major depressive disorder. Psychostimulants were the treatments of choice for

patients with attention-deficit hyperactivity disorder. Newer atypical antipsychotics were considered first-line therapy for

self-injurious behavior. For patients with nonaggressive agitation, anticonvulsants-mood stabilizers were rated first-line

by both groups. Antidepressants were the treatments of choice for patients with suicidal ideation or behavior.

Agreement between the practitioners and the medication experts was further evident in their choices of preferred

medications within different classes for the treatment of target symptoms in patients not meeting the criteria for a DSM-

IV diagnosis. Risperidone was preferred among antipsychotics for treating self-injurious behavior and aggressive or

destructive behavior. Divalproex and valproate were preferred anticonvulsants-mood stabilizers for the treatment of

self-injurious behavior, aggressive or destructive behavior, and psychiatric or behavioral problems in patients with co-

morbid epilepsy. SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline) were preferred by both groups

when an antidepressant was indicated for depressive symptoms, self-injurious behavior, aggressive or destructive

behavior, nonaggressive agitation, or anxiety. SSRIs were also the preferred anxiolytics for treating anxiety, self-injurious behavior, and aggressive or destructive behavior.

Differences between practitioners and medication experts

Significant differences between practitioners and medication experts were apparent in the recommendations regarding

uses of venlafaxine, mirtazapine, and lithium (Table 1). The practitioners considered venlafaxine a first-line agent for

major depressive episodes and the target symptom of depression. The medication experts rated it high second-line

therapy for these clinical presentations. The practitioners also considered venlafaxine first-line as an alternative agent

when no response was seen with SSRIs in patients with nonpsychotic depression, whereas the medication experts

rated it high second-line.

The practitioners favored mirtazapine more than the medication experts when treating the target symptoms ofdepression, self-injurious behavior, and aggressive or destructive behavior. The practitioners considered mirtazapine

first-line as an alternative agent when no response was seen with SSRIs in patients with nonpsychotic depression.

Assuming a partial response to an adequate trial of an SSRI for nonpsychotic depression, the practitioners considered

lithium augmentation first-line adjunctive therapy, whereas the medication experts rated lithium second-line.

The practitioners rated the following medications higher than the medication experts in terms of long-term safety and

adverse-effect profiles (if maintained at a steady dosage and with minimal monitoring): "other newer

antidepressants" (bupropion, venlafaxine), "newer atypical antipsychotics" (olanzapine, quetiapine, risperidone), and




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"newer sedating antidepressants" (mirtazapine, nefazodone).

The practitioners were more inclined than the medication experts to initially treat self-injurious behavior and other

symptoms disruptive to the patient's family and caregivers with a psychotropic medication. In addition, the practitioners

were more apt than the medication experts to continue pharmacologic treatment for the clinical factors of nonresponse

to psychosocial interventions and symptoms disruptive to the patient's family and caregivers.

Discussion

The psychiatrists treating mentally retarded patients in the TXMHMR system were largely in agreement on

pharmacologic treatments and strategies for mental illness in the mentally retarded (as indicated by the narrowness of

the 95% CIs for their responses). The practitioners agreed with each other regarding the initial treatments of choice for

specific DSM-IV psychiatric disorders and some of the severe and persistent psychiatric and behavioral target

symptoms for which reliable diagnoses cannot be made (physical aggression toward people or property, anxiety, and

suicidal ideation or behavior). Although guidelines for the treatment of mental illness in mentally retarded patients have

not been implemented in the TXMHMR facilities, the overall consensus among the practitioners is noteworthy.

Practitioners have been criticized as not basing their daily practice on solid scientific evidence. [16] But realistically, they

cannot both evaluate all the current data on treatment that might affect their daily practice decisions and care for

patients. Thus, the overall agreement in the survey findings between the practitioners and medication experts is

encouraging. In addition, the concordance between the two groups provides face validity to the PBPMR guidelines.

The practitioners were more inclined than the medication experts to use the newer antidepressants venlafaxine and

mirtazapine for the treatment of specific DSM-IV psychiatric disorders and some of the severe and persistent target

symptoms for which reliable diagnoses cannot be made. Several possible reasons exist for this finding. First,

practitioners are susceptible to the pharmaceutical industry's marketing strategies, especially the influence of sales

representatives. Up to 87% of physicians and 51% of medical residents have interactions with pharmaceutical

company representatives several times per month.[17] The passage of time (six to seven months) between publication

of the PBPMR guidelines and this study may have allowed for more contact between the practitioners and sales

representatives. These interactions can influence physicians and residents to prescribe new drugs preferentially. [18]

Venlafaxine and mirtazapine -- recent additions to the market -- are marketed as first-line alternatives to moreestablished antidepressants, such as SSRIs.

Second, the medication experts may have been more likely than the practitioners to base their decisions on scientific

evidence. Efficacy and adverse-effect studies of newer anti-depressants used in mentally retarded people are few, and

medication experts could conceivably be more cautious in using these medications as first-line agents. This is most

obvious in the use of mirtazapine for the target symptom of aggressive or destructive behavior. Despite there being no

published reports of mirtazapine's efficacy for this problem, the practitioners rated it as high second-line to first-line

therapy. The medication experts, on the other hand, considered mirtazapine to be second-line.

Third, the Texas Medication Algorithm Project (TMAP) has rated these newer antidepressants as first-line alternatives

in the treatment of major depressive disorder in the non-developmentally impaired population. [19] These guidelines and

treatment algorithms have been widely disseminated throughout Texas, and some community mental health and

mental retardation centers had received training on the treatment algorithm for major depressive disorder at the time of

the survey. Even though the TMAP recommendations apply only to treatment of major depressive disorder, this may

have influenced the practitioners' responses. Venlafaxine and mirtazapine have shown some superiority in efficacy for

severe depression compared with SSRIs, and they have desirable safety profiles in the event of overdose and few

documented drug interactions.[20-23] Mirtazapine has sedative effects that theoretically may be beneficial in the

treatment of behavioral or aggressive target symptoms.[22] Even in the absence of conclusive data, these potential

advantages of the newer antidepressants may promote their use by clinicians for patients who are severely depressed,

suicidal, taking multiple medications, or showing behavioral or aggressive target symptoms.




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Fourth, these response differences might reflect more rapid adoption of new treatments by practitioners than by

medication experts.

The practitioners, but not the medication experts, rated lithium augmentation as first-line adjunctive therapy for a partial

response to SSRIs for nonpsychotic depression. Again, a possible explanation for this difference may be the TMAP

recommendations, which advise lithium augmentation as a first-line option in patients demonstrating no response or a

partial response to antidepressant monotherapy.[19] Lithium has been widely studied as augmentation treatment in

depressed patients who respond partially to antidepressants. Favorable responses to lithium augmentation have been

seen in controlled studies involving several classes of antidepressants, including SSRIs, tricyclic antidepressants, and

monoamine oxidase inhibitors.[24,25]

Other differences between the practitioners' and the medication experts' opinions may have been influenced by the

treatment environment. When symptoms were disruptive to patients, their families, or caregivers, the practitioners

tended to prefer drug therapy management. On the other hand, the medication experts were more inclined to

recommend psychosocial and behavioral therapy before initiating drug therapy. In the clinical setting, the safety of the

patient, the family, caregivers, and other patients is of great importance, and practitioners are often encouraged to "do

something" immediately. Psychosocial and behavioral interventions require time to work, but in some circumstances

rapid control of symptoms is of the essence. Although research evidence supports the use of behavioral therapy, the

availability of consistent behavioral therapy in the community is often inadequate. Behavioral treatment is not often wellreceived in mental health care settings and meets resistance in the form of organizational barriers, lack of knowledge, a

tendency to punish patients, and staff opposition.[26,27] Staff members sometime believe that behavioral therapy is

"common sense," and as a result this pessimistic attitude can have negative effects on patients' behavior.

This study has limitations. The number of responding practitioners (n = 37) was smaller than the number of medication

experts (n = 51). Possible explanations include practitioner relocation, lost surveys in the mail, and unwillingness to

complete and return the survey. Another limitation is that practitioner responses may or may not reflect actual practice

behavior. Several studies suggest that practitioners' behavior may not be consistent with their opinions about certain

clinical circumstances and treatment guidelines. For example, Pathman et al.[28] found that only 30.1% of physicians

followed the hepatitis B vaccination recommendation for infants, even though 98.4% were aware of it. Christakis and

Rivara [29] found that, although 66% of pediatricians were familiar with the American Academy of Pediatrics

hyperbilirubinemia guidelines, only 28% adhered to them. Follow-up studies are needed to determine if physicians'

practice behavior is consistent with their responses in this survey.

Conclusion

Practicing psychiatrists and medication experts were in general agreement regarding the use of psychotropic

medications for mental illness in patients with mental retardation.

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6. Spreat S, Conroy JW, Jones JC. Use of psychotropic medication in Oklahoma: a statewide survey. Am J Ment




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Authors and Disclosures

Nick C. Patel, Pharm.D., is a graduate student and psychiatric pharmacy resident, College of Pharmacy, The

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7. McEvoy JP, Scheifler PL, Frances A. The Expert Consensus Guideline Series: treatment of schizophrenia 1999.

J Clin Psychiatry. 1999; 60(suppl 11):1-80.

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compulsive disorder. J Clin Psychiatry. 1997; 58(suppl 4):1-72.

9. Sachs GS, Printz DJ, Kahn DA et al. The Expert Consensus Guideline Series: medication treatment of bipolar

disorder

10. Postgrad Med Spec Rep. 2000; Apr:1-104.11. Foa EB, Davidson JRT, Frances A. The Expert Consensus Guideline Series: treatment of posttraumatic stress

disorder. J Clin Psychiatry. 1999; 60(suppl 16):1-76.

12. Alexopoulos GS, Silver JM, Kahn DA et al. The Expert Consensus Guideline Series: treatment of agitation in

older persons with dementia. Postgrad Med Spec Rep. 1998; Apr:1-88.

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in mental retardation. Am J Ment Retard. 2000; 105:159-226.

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17. Trivedi MH, Rush AJ, Crismon ML et al. Treatment guidelines and algorithms. In: Dunner DL, Rosenbaum JF,

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19. Peay MY, Peay ER. The role of commercial sources in the adoption of a new drug. Soc Sci Med. 1988;

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Conference Panel on Medication Treatment of Major Depressive Disorder. J Clin Psychiatry. 1999; 60:142-56.

21. Hirschfield RM. Efficacy of SSRIs and newer antidepressants in severe depression: comparison with TCAs. J

Clin Psychiatry. 1999; 60:326-35.

22. Schatzberg AF. Antidepressant effectiveness in severe depression and melancholia. J Clin Psychiatry. 1999; 60

(suppl 4): 14-21.

23. Nelson JC. Safety and tolerability of the new antidepressants. J Clin Psychiatry. 1997; 58(suppl 6):26-31.

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role of cytochrome P450 2D6. Clin Pharmacokinet. 1995; 29(suppl 1):10-8.

25. Rouillon F, Gorwood P. The use of lithium to augment antidepressant medication. J Clin Psychiatry. 1998; 59

(suppl 5): 32-9.

26. Nelson JC. Augmentation strategies in depression 2000. J Clin Psychiatry. 2000; 61(suppl 2):13-9.

27. Hilton NZ, Simmons JL. Adverse effects of poor behavior management of an inpatient's difficult behaviors.

Psychiatr Serv. 1999; 50:964-6.

28. Corrigan PW, McCracken SG, Edwards M et al. Staff training to improve implementation and impact of

behavioral rehabilitation programs. Psychiatr Serv. 1997; 48:1336-8.

29. Pathman DE, Konrad TR, Freed GL et al. The awareness-to-adherence model of the steps to clinical guideline

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Pediatrics. 1998; 101:825-30.




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Acknowledgments The assistance of Ruth Ross, M.A., and David Ross, M.A., M.C.E., of Ross Editorial Services is acknowledged.

Funding InformationSupported in part by educational grants from Pfizer, Inc., and by the Texas Department of Mental Health and Mental Retardation.Submitted to the College of Pharmacy, UTA, in partial fulfillment of the requirements for the doctor of pharmacy degree (honors program).

American Journal of Health-System Pharmacy. 2001;58(19) 2001 American Society of Health-System Pharmacists

University of Texas at Austin (UTA). M. Lynn Crismon, Pharm.D., is Professor and Southwestern Drug Corporation

Centennial Fellow in Pharmacy, College of Pharmacy, UTA, and Clinical Psychopharmacologist, Office of the Medical

Director, Texas Department of Mental Health and Mental Retardation, Austin. A. John Rush, M.D., is Professor and

Vice Chairman for Research, Betty Jo Hay Distinguished Chair in Mental Health and Rosewood Corporation Chair in

Biomedical Science, Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas. Allen

Frances, M.D., is Professor, Department of Psychiatry, Duke University, Durham, NC.


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