Prevalence and Correlates of Psychotropic Medication Use among Adults with Developmental Disabilities: 1970–2000

Prevalence and Correlates of Psychotropic Medication Use among Adults with Developmental Disabilities: 1970–2000 MARIA G. VALDOVINOS peabody college, vanderbilt university nashville, tennessee STEPHEN R. SCHROEDER life span institute, university of kansas lawrence, kansas GEUNYOUNG KIM vanderbilt university nashville, tennessee According to Aman and Singh (1988), people with mental retardation are among the most medicated in our society. Throughout the years, studies have measured the prevalence of psychotropic medication use among people with developmental disabilities and have attempted to identify the factors that are related to the prevalent use of psychotropic medication in this population. Although several variables have been identified (e.g., age, target behaviors, living setting), there has not been a general consensus on which of those variables most influences the use of psychotropic medication. Given the history of psychotropic medication use with people with developmental disabilities, one might speculate that barriers to community integration, such as communication deficits and target behaviors, contribute to this high prevalence of medication use. Sprague and Werry (1971), in their classic International Review on Research in Mental Retardation paper on the methodology of psychopharmacological studies in mental retardation, ushered in a new era of a critical review of the use of psychotropic medications among people with mental retardation. This chapter is a review of what has happened with patterns INTERNATIONAL REVIEW OF RESEARCH IN MENTAL RETARDATION, Vol. 26 0074-7750/03 $35.00

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Copyright 2003 Elsevier Science (USA). All rights reserved.

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and prevalence of psychotropic medication use by adults with developmental disabilities (DD) in the past 30 years since their review and attempts to identify those variables highly correlated with psychotropic medication use.

I. LEGAL HISTORY OF THE USE OF PSYCHOTROPIC MEDICATION WITH ADULTS WITH DEVELOPMENTAL DISABILITIES Evaluating the prevalence of psychotropic medication use among people with developmental disabilities is important given the historical and legal background surrounding the issue of psychotropic medication use and this population. Beginning in the 1970s, people became aware of terrible conditions within state institutions. Having learned about the deplorable physical conditions of state institutions and the inadequate care provided, many parents took legal action, which resulted in a variety of legislative and court-directed outcomes, primarily mandating states to improve the conditions within institutions, provide a minimum standard of care, and provide active treatment with undue restraint, which included the misuse, abusive use, or indiscriminate use of psychotropic medications (e.g., Clites vs State of Iowa, 1982; Garrity vs Gallen, 1981; Halderman vs Pennhurst State School and Hospital, 1977, 1979, 1994; Thomas S. vs Flaherty, 1988; Welch vs Gardebring, 1987; Welsch vs Likins, 1974, 1977; Wuori vs Zitnay, 1978; Wyatt vs Stickney, 1972). The first case to address the rights of people diagnosed with mental retardation to active treatment, along with the terrible conditions of the institution and undue restraint, was Wyatt vs Stickney (1972). As the seminal case, Wyatt vs Stickney (1972) provided a basis and set the standard for lawsuits filed in other states. These provisions were that (a) chemical restraints only be used when ordered by a physician, (b) medication not be used as punishment, substitutes for habilitation, or staff convenience, (c) appropriately trained staff administer medication and that training be received on a regular basis by staff, and (d) that monthly reviews of medication status be conducted. Other specific outcomes that resulted from other lawsuits included the collection of data on aberrant behavior, individualized use of medication, recording how and when antipsychotics were used, implementing treatment plans, and monitoring side effects of medication such as tardive dyskinisia. (For more details on the description of litigation, legislation, and regulations that have evolved as a result of these and other cases, see Sprague, 1982; Sprague & Galliher, 1988; Singh, Guernsey, & Ellis, 1992; Kalachnik et al., 1998.)

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These issues continue to be addressed in current litigation (e.g., United States of America vs Tennessee (W. D. Tenn), 1995, 1999; People First of Tennessee vs Arlington Developmental Center, 1992). Under the Civil Rights of Institutionalized Persons Act (1997) (CRIPA), the United States Attorney General was given the authority to investigate conditions in public facilities and take action if unlawful actions are taken against a person’s constitutional or federal statutory rights. For example, during the fiscal year of 1997, unlawful conditions were found in 73 publicly operated facilities. Of these, 13 were facilities for persons diagnosed with mental retardation (HCFA, 1997). Although these resulting case laws dealt with a part of a jurisdiction, they did not always extend to the entire federal jurisdiction. Federal laws extend to every jurisdiction and have fiscal incentives attached to ensure compliance with these laws so that if recipients are not in compliance with these laws, federal funding is lost. Furthermore, Congress has presented findings with respect to the rights of individuals with developmental disabilities. Mainly, federal and state governments have the obligation to assure that public funds are not provided to institutions or other residential programs that use chemical restraints on individuals or use psychotropic medication as punishment, substitute for habilitation programs, or in quantities that interfere with services such as treatment or habilitation (e.g., DD Act, 1998; HCFA, Medicaid, Patient Freedom from Restraint Act, 2000). A great quantity of funding for programs that provide services to adults with DD is granted through Title XIX (1973) of the Social Security Act, more commonly known as Medicaid. Section 1915(c) of Title XIX (1973), Home and Community-Based Services (HCBS) waivers, is used to prevent institutionalization or to find community placement for people with DD and to provide services such as case management, home health aide services, personal care services, adult day health, habilitation, and respite care. For adults with DD, these waivers are meant to facilitate habilitation in the least restrictive environment within the general community. More recently, Senators Lieberman and Dodd introduced the Patient Freedom from Restraint Act of 1999 (2000) as an amendment to Title XI of the Social Security Act. This act extended restraint protections for nursing home residents to all mental health patients in facilities receiving Medicaid or Medicare funds, including people with DD. The first part of the act deals with the reporting of unexpected occurrences resulting in serious injury or death. The second part of the act addresses the protection and promotion of an individual’s right to be free from physical or mental abuse, corporal punishment, involuntary seclusion, and any restraints imposed for the purposes of discipline or convenience. The act specifies that the only time that restraints can be used is when ensuring the physical safety of the

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individual or others in the care or custody of the provider. Furthermore, in order for restraints to be used, a physician must provide a written order and specify the duration and circumstances when restraints are to be used (with the exception of emergency situations until an order is obtained). Finally, since the early 1970s, professionals have worked to establish guidelines and standards for providing appropriate treatment using psychotropic medications (beginning with Freeman in 1970, the Accreditation Council for Facilities for the Mentally Retarded in 1971, Accreditation Council on Services for People with Developmental Disabilities in 1987, the American Psychiatric Association in 1990, International Consensus Conference on Psychopharmacology in 1995 [Reiss & Aman, 1997]). (For a more detailed review of professional standards, see Kalachnick, 1999b.) As described, steps have been taken in the past three decades to monitor the use of psychotropic medication. Another step for monitoring psychotropic medication use is to evaluate the prevalence of use among this population.

II.

BRIEF OVERVIEW OF PSYCHOTROPIC MEDICATION

Psychotropic medications can be classified into seven groups: (a) neuroleptics, (b) antidepressants, (c) anxiolytics and sedatives, (d) stimulants, (e) anticonvulsants, (f) mood stabilizers, and (g) other. An issue encountered during this review was related to the categorization of four other medication classes, specifically major and minor tranquilizers, hypnotics, and sedatives. These were major medication class divisions up until and during the 1970s after which they were consolidated into other classes. In order to maintain consistent classifications for medications across the years, major tranquilizers were classified as antipsychotics or neuroleptics. Minor tranquilizers, hypnotics, and sedatives were classified as anxiolytics, unless the names of the minor tranquilizers were provided and a distinction could be made among anxiolytics, beta blockers, antidepressants, and mood stabilizers. The following section is intended to provide a brief description of the indications for the use of these medications with people with DD, their general effects, and common side effects. A.

Neuroleptics

Neuroleptics, or antipsychotics, are generally prescribed to treat psychoses, motor and vocal tics, combative explosive behavior, hyperactivity, anxiety, and a number of medical ailments, such as uncontrollable nausea, vomiting, and hiccups (Baumeister, Sevin, & King, 1998). In addition to the afore-mentioned indications, other uses of neuroleptics with

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people diagnosed with DD include aggression and self-injurious behavior (SIB). Baumeister, Sevin, and King (1998) conducted a review of studies that have evaluated the efficacy of neuroleptics in treating problem behaviors. A majority of the results from these studies (67%) conclusively indicated that the use of neuroleptics decreased either rate or severity of aggression and SIB, and also reduced stereotypy and hyperactivity. Although neuroleptics have been shown to be efficacious, there is a risk of side effects. Side effects commonly associated with the use of neuroleptics include sedation, behavioral toxicity, extrapyramidal effects, and weight gain (Baumeister et al., 1998; Campbell, Gonzalez, Ernst, Silva, & Werry, 1993). Sedation is the most common side effect associated with neuroleptic use and is usually immediate and short term. Behavioral toxicity refers to the worsening of existing problem behaviors or the development of new ones. Extrapyramidal side effects (EPS) is a term referring to movement disorders. Some EPS affect individuals differently than others. For example, with pseudo-Parkinsonism, the individual may experience tremors, rigidity, extremely slow movement, shuffling gait, and akinesia (absence of voluntary movement, gesture spontaneity, emotions, and speech). Akathisia involves motor restlessness, pacing, and the inability to sit still (Baumeister, Sevin, & King, 1998; Bodfish, Crawford, Powell, Parker, Golden, & Lewis 1995; Bodfish, Newell, Sprague, Harper, & Lewis, 1997; Ganesh, Rao, & Cowie, 1989). Acute dystonias involve extreme muscle rigidity or muscle spasms usually occurring with the tongue, eyes, neck, jaw, esophagus, back, or trunk. Usually, reducing the dose of medication can treat these symptoms (Baumeister et al., 1998). Tardive dyskinesia, however, is generally but not always associated with the long-term use of neuroleptic medication and consists of repetitive involuntary movements of the face (including lips, jaws, tongue, eyebrows) and sometimes the trunk and limbs. A newer group of neuroleptics, referred to as atypical or novel antipsychotics, have been recently introduced for treatment in individuals with MR/DD. This new group is said to be efficacious while producing fewer EPS than the older generation of medication (typical antipsychotics) (Baumeister et al., 1998). At this time, however, it is unclear whether long-term use of these medications will result in similar resulting EPS. B.

Antidepressants

Antidepressants are generally prescribed to treat affective disorders (including depression), obsessive-compulsive disorders (OCD), attention deficit hyperactivity disorder (ADHD), nocturnal enuresis, anxiety disorders, and eating disorders. Antidepressants may be prescribed for people with DD to treat ritualistic behaviors, enuresis, SIB, and aggression in

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addition to the afore-mentioned disorders (Sovner, Pary, Dosen, Gedye, Barrera, Cantwell, & Huessy, 1998). Sovner et al. (1998) reviewed the literature concerning the effects of antidepressants on depression, OCD and like behaviors, aggression, and SIB in children and adults diagnosed with mental retardation. Results from a majority of the studies indicated that antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), were effective in decreasing many of these problem behaviors. Within the class of antidepressants, the three most common types of antidepressants are (a) monoamine oxidase inhibitors (MAOIs), (b) tricyclic antidepressants (TCAs), and (c) SSRIs. MAOIs, however, are rarely used today to treat people with mental retardation because of risks involving food and drug interactions (Sovner et al., 1998). The most common side effects displayed by patients prescribed TCAs include dry mouth, sedation, dizziness, lethargy, tremors, jitteriness, insomnia, and nausea. Observed but less common side effects are constipation, palpitations, orthostatic hypotension, cardiotoxicity, blurred vision stomach ache, weight gain, seizures, and perspiration (Sovner et al., 1998; Viesselman, Yaylayan, Weller, & Weller, 1993). SSRIs have relatively few side effects, but increased agitation and/or hypomania, insomnia, headache, dry mouth, appetite suppression, decreased libido, drowsiness, and gastrointestinal symptoms (nausea, vomiting, and diarrhea) can occur. However, these side effects are usually slight and short term (Racusin, Kovner-Kline, & King, 1999). C.

Anxiolytics and Sedatives

Anxiolytics or sedatives include medications such as (a) barbiturate-like medications, (b) benzodiazepines, (c) antihistamines, and (d) buspirone. These medications are generally prescribed as antianxiety medication that can also be used to aid in sleep problems, control epilepsy, and stabilize mood. With anxiolytics, the symptoms are usually masked and the disorder is untreated. Thus, they are rarely used as long-term treatment (Werry, 1998). These medications have been prescribed most commonly to treat aggression, SIB, elopement (running away), avoidance, sleep disturbance, and restlessness in people with mental retardation; however, there is no conclusive evidence pertaining to the effectiveness of anxiolytics for treating these behaviors (Werry, 1998, 1999). Side effects include sedation, disinhibition, hyperactivity, irritability, and aggressiveness for all anxiolytics and sedatives, with the exception of antihistamines, buspirone, and clonidine. Other grave side effects associated with anxiolytics and sedatives are possible memory impairment, impairment of other cognitive functions and motor coordination, and slowing of psychomotor functions (Werry, 1998). The potential exists for chemical

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dependency and rebound effects after long-term use (Unis & McClellan, 1993). D.

Stimulants

This class of medication is mainly used to treat ADHD in the general public as well as with people with mental retardation. Less commonly they are used to treat narcolepsy. Stimulants have been shown to be effective in improving attention, decreasing impulsivity, and restlessness in people diagnosed with ADHD (Barkley, DuPaul, & Costello, 1993). For people with mental retardation, however, response to stimulants varies and does not appear to be as effective as with people in the general public (Arnold, Gadow, Pearson, & Varley, 1998). Common side effects associated with the use of stimulants include insomnia, anorexia (loss of appetite), headache, stomachache, nausea, irritability, nervous tics, and increased talkativeness (Arnold, Gadow, Pearson, & Varley, 1998; Barkley et al., 1993). Long-term side effects include the potential for drug dependency and abuse, growth retardation, and potential cardiovascular effects (Barkley et al., 1993). E.

Mood Stabilizers and Anticonvulsants

Traditionally, anticonvulsants have been used to treat seizure disorders. In addition, psychiatrists have found another use for certain anticonvulsants as mood stabilizers in the treatment of mania, major depression, aggression, other mood disorders (e.g., bipolar disorders, mixed affective disorders, unipolar and bipolar depression), dementia, and psychotic and schizoaffective symptoms (Poindexter, Cain, Clarke, Cook, Corbett, & Levitas, 1998; Viesselman et al., 1993). Hellings (1999) indicated that people with mental retardation also have mood disorders; however, it is often difficult to diagnose these mood disorders due to the generic nature of presenting problems. A majority of studies conducted to evaluate the efficacy of mood stabilizers, such as lithium, used aberrant behaviors (e.g., aggression and SIB) as dependent variables, as opposed to ‘‘manic’’-like or other behaviors, and found decreases in problem behavior in a majority of the cases (Hellings, 1999; Poindexter et al., 1998). A discussion of side effects for this class of medication necessitates the consideration of the toxicity of lithium, which may cause tremors in the fingers, vomiting, chronic nausea, severe diarrhea, ataxia, coma, convulsions, edema, hypothyroidism, weight gain, and polyuria (Poindexter et al., 1998). Other mood stabilizers, such as certain anticonvulsants, can cause vertigo, drowsiness and sedation, unsteadiness, nausea, vomiting, and dizziness (Viesselman et al., 1993).

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Maria G. Valdovinos, Stephen R. Schroeder, and Geunyoung Kim Other Medications

Finally, medications are used to address behavior problems and psychiatric illnesses of people with DD that do not fall into the aforementioned medication classes. These medications are
-adrenergic blockers, opiate blockers, and -adrenergic agonists (e.g., clonidine, guanfacine). However, their use was typically not reported throughout the literature and thus their prevalence is not discussed in this review.

III.

PREVALENCE STUDIES

Between the years of 1970 and 2000, 68 studies reporting the percentage of people using psychotropic medication were published. The methods used to find these studies and the criteria used to include the studies were that they were written in English, audited adults with developmental disabilities, and reported the percentage of any psychotropic medication use. Therefore, studies conducted in different countries that reported the findings in English were included in this review. The first part of this section reviews the percentages of psychoactive and psychotropic medication use by decade, examines trends of reported psychoactive and psychotropic medication across all the years, and identifies reported correlates. The second part of this section reviews the methodologies of these studies. One difficulty we encountered in reviewing prevalence studies was the frequent interchangeable use of the definitions of psychotropic and psychoactive medication (i.e., Anderson & Polister, 1993). Often, if distinctions between the two terms were made, there would be two different rates reported, one for psychoactive use and one for psychotropic use. Usually, psychotropic medication has been included in psychoactive medication figures. For the purposes of this review, the definitions provided by Aman and Singh (1983) in the Handbook of Mental Retardation (Matson & Mulick, 1983) were used for determining what each study was reporting. Psychoactive refers to the effect of a medication regardless of intent or anticipated effect of the medication on behavior, emotion, or cognition, whereas psychotropic refers to a medication that is administered for the purpose of producing behavioral, emotional, or cognitive effects. Similarly, the role and categorization of anticonvulsants have not been treated consistently across investigations. Some studies reported the prevalence of anticonvulsant use without attempting to assign or discriminate the purpose for its prescribed use (e.g., seizure control). Other studies attempted to make this distinction and reported the use of anticonvulsants as antiseizure medication or psychotropic medication. Unfortunately, in

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those studies where distinctions were not made between psychoactive and psychotropic medication, anticonvulsants were reported as psychoactive medication even though the purpose for their use was seizure control, thus inflating reports of psychotropic medication use. A.

Prevalence Figures

This section is organized by decades beginning with 1970, when Lipman published the first important prevalence study, to 2000 wherein Ono published the most recent prevalence study in 1998 (1970 to 1979, 1980 to 1989, and 1990 to 2000). 1. 1970–1979 Between these years, the overall reported percentage of people with DD in all settings using psychotropic medication ranged from 21 to 86%, with a mean of 47.1% and a median of these percentages of 40%. In Table I, the range, mean, and median are provided to illustrate that even with the variance in reported percentages, all the studies, within each decade, were consistent with each other. Furthermore, the means and medians provided are of the percentages reported in the studies reviewed. Weighted means were not used. Psychoactive medication use ranged from 51 to 70% with a mean of 56.1% and a median of 66%. Thus, while the range of reported psychoactive use is smaller than of psychotropic use, the average use of psychoactive medication is higher. Similar percentages are found in institutional settings during this time with a range of 21 to 83%, a mean of 57.6%, and a median of 60%. There was only one percentage provided for community settings—30% (Hancock, Weber, Kaza, & Her, 1991). With the exception of antidepressants, stimulants, and mood stabilizers, there was great variability in the percentages reported for each medication class during this decade. 2. 1980–1989 During these years, the overall percentage of people with DD using psychotropic medication ranged from 12 to 63%, with a mean of 29.5% and a median of 24%. Psychoactive medication use ranged from 29 to 74% with a mean of 51.6% and a median of 51%. Slightly lower percentages were found in institutional settings during this time with a range of 27 to 76%, a mean of 47.1%, and a median of 47%. An even lower percentage of people using psychotropic medication in community settings was found with a range of 12 to 49%, a mean of 30.5%, and a median of 25.9%. There appeared to be greater variability in the percentages reported, particularly for the neuroleptic, anticonvulsant, and anxiolytic classes. Although the

TABLE I Decade Ranges, Means, and Medians of Percentage of People with Developmental Disabilities Using Medication Setting

Medication type

Class of psychotropic medication

Decade Institution Community Psychoactive Psychotropic Neuroleptic Antidepressant Anxiolytic Stimulant Anticonvulsant Mood stabilizer 1970

21–83% (57.6%)a 60%b

30% (30%) 30%

51–70% (56.1) 66%

21–86% (47.1%) 40%

12–39.1% (25.4%) 24%

0.2–3.8% (2.9%) 3.3%

0–35.6% (13.7%) 8.1%

1980

27–76% (47.1) 47%

12–49% (30.5%) 25.9%

29–74% (51.6%) 51%

12–63% (29.5%) 24%

9.5–57.6% (28.7%) 28.8%

0–9.5% (2.2%) 1.8%

1990

23–60.4% (46.8%) 56.5%

13–41% (28.8%) 30.2%

27–46.8% (40.6%) 38%

18–49% (30.9%) 25.7%

19.4–60.4% (29.9%) 23%

2.1–7.8% (4.9%) 4.9%

a b

Means are expressed in parentheses. Medians are expressed in bold.

0.7–0.9% (0.8%) 0.75%

23–34.2% (27.6%) 26.9%

0.2–2.3% (1.3%) 0.2%

1.1–21.6% 0–1.5% (7.7%) (0.5%) 7.2% 0.35%

14.7–46.4% (28.2%) 27.3%

0–4.4% (1.9%) 1.4%

4.2–36% (13.9%) 13.3%

5.4–29% (20.7%) 21.8%

1.4–6.6% (4.4%) 4.6%

0.1–6.6% (1.9%) 0.35%

prevalence of psychotropic medication use

185

reported ranges, means, and medians for all medication classes, with the exception of the ranges and means of anxiolytics, were comparable to the prior decade, overall psychotropic use and use of psychotropic medication in institutional settings decreased. 3. 1990–2000 Between these years, the percentage of people with DD using psychotropic medication ranged from 18 to 49%, with the mean percentage of people with DD using psychotropic medication being approximately 30.9% and a median of 25.7%. Psychoactive medication use ranged from 27 to 56.3% with an approximate mean of 40.6% and a median of 38%. Comparable percentages were found in institutional settings during this time with a range of 23 to 60.4%, a mean of approximately 46.8%, and a median of 56.5%. A comparable percentage of people using psychotropic medication in community settings was also found with a range of 13 to 41%, a mean of approximately 28.8%, and a median of 30.2%. While there appeared to be even greater variability in the percentages reported for the neuroleptic, anticonvulsant, and anxiolytic classes, neuroleptic mean use increased; however, toward the end of the decade, neuroleptic medication use was lower than it was at the beginning. Furthermore, the mean use of anticonvulsants was lower than the previous decades. Conversely, the use of anxiolytics appears to be increasing according to these data. While the reported mean use of psychotropic medication remained similar to the previous decade, the ranges of antidepressant, stimulant, and mood stabilizer use increased. Nonetheless, mean psychotropic use in institutional and community settings remained comparable to the previous decade. For some of the prevalence studies conducted, the authors provided the year when data were collected. Other studies did not indicate the year of data collection. Thus, for Figs. 1–3, if a specific year was identified, data were plotted for the corresponding year; however, if there was not a year specified, the year of publication was used to report the prevalence figure obtained. The trends of reported psychotropic medication use among adults with DD across the years were also examined. Figure 1 illustrates the percentage of reported medication use (psychoactive, psychotropic) through these years. The distinction between the two terms is made in Fig. 1 because some reports of medication use specifically used the term psychoactive or psychotropic. Since it is impossible to determine if the authors were using psychoactive and psychotropic interchangeably, two measures were reported. A regression analysis was performed to test whether there is a linear relationship in drug use over time. Average drug use data obtained from the articles reviewed per each year were entered as a dependent

Maria G. Valdovinos, Stephen R. Schroeder, and Geunyoung Kim 100 90 80 70 60 50 40 30 20

2000

1995

1990

1985

1980

0

1975

10 1970

Percentage of Population Using Medication

186

Years Psychoactive Linear (Psychoactive)

Psychotropic Linear (Psychotropic)

FIG. 1. Reported use of psychotropic and psychoactive medication between the years of 1970 and 2000. Trend lines are presented for each category of medication.

variable predicted by year. There was a significant decrease in psychoactive [F (1, 15) ¼ 20.74, p < .001, adjusted R2 ¼ .56] and psychotropic [F (1, 15) ¼ 6.15, p < .05, adjusted R2 ¼ .18] medication use from 1970 to 2000. Referring to Table I, neuroleptic medication use has remained fairly constant throughout the years evaluated. However, there is a slight decrease, although not statistically significant, in the reported use of anticonvulsant medication. This decline could be an artifact of changed categorization: In the past, anticonvulsants used to control seizure activity were considered to be psychoactive. Today, however, it is more common for anticonvulsants to be classified and used as psychotropic medication prescribed for the purpose of behavior control. Thus, in reality the use of anticonvulsants may not have decreased but rather the designated purposes are more specific. Finally, the reported use of antidepressants, anxiolytics, and stimulants, while relatively low and seemingly increasing over the years, does not reflect statistically significant changes over the years reported. Meanwhile, there was a statistically significant increase in mood stabilizer use. Figure 2 illustrates the prevalence of psychotropic medication use in institutional settings versus community placements. A t test was performed to compare fits between institution and community data. The test showed

187

prevalence of psychotropic medication use

90 80 70 60 50 40 30 20

2000

1995

1990

1985

1980

0

1975

10 1970

Percentage of People Using Medication

100

Years Institution Linear (Institution)

Community Linear (Community)

FIG. 2. Reported use of psychotropic medication in institutional and community settings between the years of 1970 and 2000. Trend lines are presented for each category of medication.

100

80 70 60 50 40 30 20 10

Years

FIG. 3. Reported percentage of polypharmacy between the years of 1970 and 2000.

2000

1995

1990

1985

1980

1975

0 1970

Percentage of Polypharmacy

90

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Maria G. Valdovinos, Stephen R. Schroeder, and Geunyoung Kim

that the regression coefficient from community data is not significantly different from that of institutional data (t31 ¼ .91, p ¼ 37). This result implies that those two regression lines do not differ from each other. There is a trend of decreasing reported use of psychotropic medication in institutional setting (
¼ .42), whereas psychotropic medication use in the community appeared to remain relatively unchanged (
¼ .21). This decreasing trend is statistically not significant (F ¼ .74, p ¼ .40), and these results seem somewhat paradoxical. For instance, it would seem more likely that the proportion of people living in institutions who used psychotropic medication would have increased as the years progressed when considering that fewer people were living in institutional settings and those individuals still residing in institutional settings were more likely those requiring the most behavioral and medical support. It would also seem more likely that the total number of people who lived in community settings would have increased with the absolute number of people taking psychotropic medication remaining unchanged. However, there might have been more individuals requiring behavioral and medical support living in the community than in years past. It should be noted that the current study’s statistical analysis was based on summary results obtained from existing prevalence studies, which implies that the number of cases presented in this review may not be optimal for statistical analysis. Green (1991), for example, suggested that required sample sizes for regression analysis should be N > 104 + m, where m is the number of independent variables, which for this study would be 105 data entries. Too few subjects in regression analysis often lead to the generation of outliers, which are critical for regression solution. Furthermore, some of the studies included in this review were conducted with the intent of measuring decreases in psychotropic medication use within a setting across time. (Generally, these studies conducted and reported multiple probes in any given publication.) Therefore, the recommendation is to pay special attention to the descriptive figures and data rather than make conclusions based on the regression analysis performed for this review. B.

Correlates

Several correlates were identified with psychotropic medication use across these studies, such as age, gender, level of mental retardation, presence of a psychiatric diagnosis, existence and severity of problem behaviors, living setting, and size. (Specific results are presented in Table II.) Other less common variables included the presence of other disabilities, vocational settings, staffing issues, and polypharmacy. Each of these is also discussed in this review.

TABLE II Correlationsa Age — S (+) N

Gender

Level of MR

Psychiatric diagnosis

Target behavior

Living setting

Living size

— N R (< severe)

— — —

— — S

R (institution) R (institution) —

— — —

R (+)

— N S with antidepressant —

R (< severe)

—

—

R (restrictive)

—

—

—

—

—

—

—

— — — —

N — — —

N — — —

— R — —

S R — S

— — R (institution) —

R (smaller <15) — — — —

N —

N N

— N

— S

— —

— —

— —

—

—

N

R

—

—

—

S (+)

N

—

—

—

S (hospital)

—

S () N N

N N N

— N —

— — —

— — —

— R (institution) —

— — —

Reference Agran and Martin (1982) Aman, Field, and Bridgeman (1985) Aman, Sarphare, and Burrow (1995) Aman, Vanbourgondien, Wolford, and Sarphare (1995) Anderson (1989) Anderson and Polister (1993) Bisconer, Sine, and Zhang (1996) Branford (1994) Branford, Collacott, and Thorp (1995) Buck and Sprague (1989) Burd, Fisher, Vesely, Williams, Kerbeshian, and Leech (1991) Burd, Williams, Klug, Fjelstad, Schimke, and Kerbeshian (1997) Clarke, Kelly, Thinn, and Corbett (1990) Craig and Behar (1980) Davis, Cullari, and Breuning (1982) Etherington, Sheppard, Ballinger, and Fenton (1995)

(continued )

TABLE II (Continued) Gender

Level of MR

Psychiatric diagnosis

Target behavior

Living setting

Living size

—

R (males)

—

—

—

—

—

R (20–30 Years of age) — N

R (diff med)

—

—

—

—

— S (women)

R (moderate/ severe) — N

— —

R —

R (institution) —

— —

R R (+)

N N

N N

— —

N S

R (congregate) R (institution)

R (larger) S (larger >14)

S (+) N

— —

S (
S —

S —

N —

N N

S (+) N S range

N N N

R (>severe) N S (>severe)

— S —

R R S

N N —

— — N R (<50)

— — N N

R (>severe) — N —

— — R R

— R N R

— — S restrictive (institution) R (institution) — R (institution) —

— — — —

—

—

R (profound)

—

—

—

—

N —

N —

R (
N —

R —

— —

— R (<500 and >3000)

Age

Reference Fernando, Regan, and Khwaja (1997) Fischbacher (1987)

190

Gowdey, Zarfas, and Phipps (1987) Hancock, Weber, Kaza, and Her (1991) Harper and Wadsworth (1993) Harper, Wadsworth, and Michael (1989) Hill, Balow, and Bruininks (1985) Hughes (1997) Intaglia and Rinck (1985) Community Institution Jacobson (1988) Jacobson and Ackerman (1993) Jonas (1980) Kiernan, Reeves, and Alborz (1995) Kohen, Matthew, and Fernando (1993) LaMendola, Zaharia, and Carver (1980) Linaker (1990) Lipman (1970)

— — S (>55) R () —

N — — — N

R (>severe) R (>severe) — — —

— — R — —

— R — — —

R (+) N — R (+) R () —

— N S (women) — — —

— N — R (severe) R (>severe)

— N — R (+) — R

R S (+) — R (+) R R

— —

R (women) —

N —

R —

— R

191

a

R (institution) — R (less restrict) — S (institution)

— — — — —

R (rural) — — — R (ICFMR) —

— — — — — —

— —

R (smaller) —

Martin and Agran (1985) Ono (1998) Pary (1993) Poindexter (1989) Rimmer, Braddock, and Marks (1995) Rinck and Calkins (1989) Sachdev (1991) Silva (1979) Spreat and Conroy (1998) Spreat, Conroy, and Jones (1997) Stone, Alavarez, Ellman, Hom, and White (1989) Tu and Smith (1979) Tu and Smith (1983)

S, statistically significant; R, relationship identified; (+), positive relationship; (), negative relationship; N, no relationship; —, not assessed.

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1. AGE For those studies that reported a relation between psychotropic medication use and age, 19.2% of the studies indicated there was a statistically significant relation between medication use and increased age (27>). Only one study stated that a statistically significant relation existed between medication use and decreased age (Craig & Behar, 1980). Studies by Jacobson (1988) and Pary (1993) indicated that there was a statistically significant relation between medication use and specific age ranges. This could be attributed to the demographic nature of their sample, specifically older adults. Other studies (15.4%) reported that there appeared to be a nonstatistically significant relation between psychotropic medication use and increased age, whereas 11.5% of the studies reported a relation between psychotropic medication use and decreased age. Finally, 38.5% of the studies stated specifically that no relation existed between medication use and age.

2. GENDER Of the studies that examined the relation between gender and psychotropic medication use, 76% indicated that there appeared to be no relation between gender and medication use. One study indicated that women were statistically significantly more likely to take antidepressants (Aman, Sarphare, & Burrow, 1995). Two other studies reported a postive relation between psychotropic medication use and the female gender (Hancock, Weber, Kaza, & Her, 1991; Silva, 1979; Tu & Smith, 1979). Only one study reported an increased incidence of psychotropic medication use in men (Fernando, Regan, & Khwaja, 1997).

3. LEVEL OF MENTAL RETARDATION Studies reported relations between psychotropic medication use and level of mental retardation. Whereas 46% of the studies evaluating this potential relation indicated that there was no relation between level of mental retardation and psychotropic medication use, two studies indicated a statistically significant relation between level of mental retardation and medication use; however, the relations contradict each other. Hill, Balow, and Bruininks (1985) reported that persons diagnosed with less severe levels of mental retardation were more likely to be prescribed psychotropic medication. However, Jacobson (1988) reported that having a diagnosis of more severe levels of mental retardation increases the likelihood that psychotropic medication will be used.

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4. PSYCHIATRIC DIAGNOSIS Most of the studies that evaluated the relation between the existence of a psychiatric diagnosis and psychotropic medication use indicated that these variables were related. Of these studies, 23.1% reported that there was a statistically significant relation between having a psychiatric diagnosis and psychotropic medication use. A higher percentage of the studies (61.5%) indicated a nonstatistically significant relation between having a psychiatric diagnosis and psychotropic medication use. Only two studies indicated that there did not appear to be any relation between the presence of a psychiatric diagnosis and psychotropic medication use (Linaker, 1990; Sachdev, 1991). 5. TARGET BEHAVIORS For those studies that examined the relation between psychotropic medication use and the presence of target behaviors (e.g., aggression, selfinjurious behavior, property disruption, hyperactivity, noncompliance), 31.8% of the studies indicated that there was a statistically significant relation between the existence of target behaviors and psychotropic medication use. Of the remaining studies, 59.1% reported a nonstatistically significant relation between the existence of target behaviors and psychotropic medication use. Only two studies found no relation between these variables (Harper & Wadsworth, 1993; Kiernan, Reeves, & Alborz, 1995). 6. LIVING SETTING For the purposes of this review, institutional settings refer to stateoperated facilities (i.e., state schools, hospitals) providing residential (and possibly vocational) services for people with DD. Community settings refer to placements integrated into existing communities, which are operated by private (not state) agencies (although these agencies are monitored by the state). Foster homes, single-family homes, or independent living programs were not included for this particular section of review. Another distinction made between living settings was along the continuum of level of restrictiveness. Of the three studies that reported on the restrictiveness of a setting, two indicated that the more restrictive the setting, the more likely it would be that psychotropic medication would be used. A restrictive setting was considered to be a setting in which the independence of an individual was limited as in institutions. This criterion was established because authors using the term ‘‘restrictive’’ did not provide definitions for the term. Aman, Van Bourgondien, Wolford, and Sarphare (1995) concluded that individuals were more likely to be prescribed neuroleptic medication if they resided and worked in a restrictive setting, and Jacobson

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(1988) reported a statistically significant relation between more restrictive settings and psychotropic medication use. Types of living arrangements were also evaluated (living with family, foster care, community residences, small intermediate care facilities for people with mental retardation (ICF/ MR), and state institutions). Pary (1993) was the only one out of three to indicate that psychotropic medication use was related to independent living or lesser restrictive settings. In their 1988 review, Aman and Singh had noted that a majority of prevalence studies up until that point had been conducted in institutional settings and few had been conducted in community settings. Between 1970 and 1983, the only prevalence figures released came from institutional settings. After 1983, more research was conducted in the community, and psychotropic medication prevalence studies shifted from deriving samples from institutions to the community. Undoubtedly, this shift reflected the change in residential patterns following the deinstitutionalization movement. Studies with direct comparisons between medication use in an institutional setting versus a community setting consistently showed that psychotropic medication use was higher in institutional settings (Baumeister, Todd, & Sevin, 1993; Branford, 1994; Errickson, Bock, Young, & Silverstein, 1981; Hill, Balow, & Bruininks, 1985; Intaglita & Rinck, 1985; Radinsky, 1984). 7. LIVING SETTING SIZE Reports including larger settings indicated that there was an increased use of psychotropic medication or that psychotropic medication use was more likely in these larger settings (Harper et al., 1989; Harper & Wadsworth, 1993; Lipman, 1970). Harper and Wadsworth (1993), when reporting about larger settings, were referring to those in which more than 14 people resided together. In Lipman’s (1970) study, however, a larger institution referred to one with more than 3000 residents, and in some other studies there was no precise quantification of ‘‘larger’’ (e.g., Harper & Wadsworth, 1993). Anderson (1989) reported that those people living in residential settings with fewer than 15 people (group homes and foster care homes) were less likely to be found taking any medication. However, other studies reported that the smaller the setting, the greater the likelihood of an increased use of psychotropic medication (Lipman, 1970; Tu & Smith, 1979). Lipman (1970) defined smaller as being fewer than 500 residents, whereas Tu and Smith (1979) referred to small institutions versus large institutions but no specific number was provided. Finally, other studies reported no relation between the size of a setting and the use of psychotropic medication (Hill et al., 1985; Hughes, 1977; Intagliata & Rinck, 1985). Overall, it would appear that the

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larger the living setting, the more likely that there is a higher prevalence of medication use. 8. OTHER CORRELATES A review provided by Aman and Singh (1988) revealed that there appeared to be a negative correlation with the use of psychotropic medication and the existence of other disabilities. That is, the more disabilities (e.g., cerebral palsy) an individual has, the less likely they are to be on psychotropic medication. Aman, Van Bourgondien, Wolford, and Sarphare (1995) and Martin and Agran (1985) found that the more restrictive a vocational setting, the more likely that there would be people using psychotropic medication. In the area of staffing, Hill Balow and Bruininks (1985) found a statistically significant relation between a low staff to consumer ratio and an increased use of psychotropic medication. Harper, Wadsworth, and Michael (1989) and Hughes (1977) also found that with a low staff to consumer ratio, psychotropic medication use was highly likely to occur. Finally, it was noted that anywhere from 4 to 60% of individuals using psychotropic medication were using more than one psychotropic medication at a time (Buck & Sprague, 1989; Burd, Fisher, Vesely, Williams, Kerbeshian, & Leech, 1991; Burd et al., 1997; Etherington et al., 1995; Fernando et al., 1997; Gowdey, Zarfas, & Phipps, 1987; Hughes, 1977; Intagliata & Rinck, 1985; Lipman, 1970; Ono, 1998). While the term polypharmacy typically refers to the use of more than one medication from the same class, for the purposes of this chapter, the term refers to those instances where individuals were either receiving medications from differing classes or more than one medication of the same class. In the late 1970s and early 1980s the reported use of multiple psychotropic medication appeared to increase. A decrease was then observed in the mid- to late 1980s. A resurgence of reported use of more than one medication appears to be occurring as more recent reports of percentages of multiple medication use indicate (see Fig. 3). For all of these statistically significant and nonstatistically significant relations, there did not appear to be trends within each decade, with the possible exception of living size. Because larger institutions or residential settings are not likely to exist in this current decade, the specific size of a setting appears to interact with the decade and the trends of those specific times. The studies were also conducted in different countries and continents; however, for the most part, the prevalence of psychotropic medication use was consistent among different countries and continents. Furthermore, there did not appear to be any consistent findings among statistically

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significant and nonstatistically significant relations within the same countries and continents. C.

Methodology

In reviewing the literature on the prevalence of psychotropic use with adults diagnosed with mental retardation and DD (MR/DD), several variations in methodology across studies were noted that made it difficult to compare results. These variations were in the areas of sampling procedures, sample size, and statistical procedures. 1. SAMPLING PROCEDURES The feature that varied the most across studies was the method by which participants were recruited for evaluation. Some studies used a sample within an institution or a ward within an institution. Others relied on information provided by community agencies. Finally, data were collected through surveys of families with a family member with a developmental disability or agency staff (see Table III). These names were often obtained from a mailing list provided by a focus group or state agency. Because little was known about the people who refused to participate, ascertainment bias could not be assessed with these samples. Procedures used to obtain information on the use of psychotropic medications and other characteristics of the population being evaluated varied. Overall, the most common methods used for obtaining information were the use of surveys and record reviews. Record reviews were different from other reviews listed in that they were not specified as being medical charts, formal agency records, or pharmacy records. As mentioned previously, 21 studies of 56 relied on information obtained by surveys completed by family members, case managers, direct-care staff, and other agency personnel. The response rate for these surveys varied from 53 to 100%. With the exception of Branford, Collacott, and Thorp (1995), these studies did not provide overall reliability measures for the results obtained. Furthermore, there were 31 studies that relied on a single report (i.e., case notes, agency records, or nursing reports) to provide the information. In 19 studies, reports were cross-referenced with either other reports or interviews with nurses, pharmacists, parents, and staff. These studies came the closest to providing the essential reliability needed to support that the figures obtained were accurate. 2. SAMPLE SIZES Understandably, a second inconsistent feature of the studies reviewed was the sample size used. Depending on the method used to recruit participants,

TABLE III Methodology Sampling procedures

Survey

Record review

Medical Agency Pharmacy chart record record

X

Ascertainment

Interview

Other

X Parents

Reliabilitya

Sampling size

Y

131

X

N

1,101

X

N

838

N N Y

2,291 369 97

Y Y

1,510 5,766

X

N

809

X

N

1,384

Y

2,059

N

4,766 1,895

X X X

X

X Case manager X X Medicaid

X

X X

Response rate (%)

100 53

62.6

Reference Aman, Field, and Bridgeman (1985) Aman, Sarphare, and Burrow (1995) Aman, Vanbourgondien, Wolford, and Sarphare (1995) Anderson (1989) Anderson and Polister (1993) Bisconer, Sine, and Zhang (1996)

Branford (1994) Buck and Sprague (1989) 97 100

Burd, Fisher, Vesely, Williams, Kerbeshian, and Leech (1991) Burd, Williams, Klug, Fjelstad, Schimke, and Kerbeshian (1997) Clarke, Kelly, Thinn, and Corbett (1990) Craig and Behar (1980)

(continued )

TABLE III (Continued ) Sampling procedures

Survey

Record review

Medical Agency Pharmacy chart record record

Ascertainment

Interview

Other

X Staff forms X X X

198

X

X

X

X

X

X

X

883.5b 630.6b

N Y

3,496 605 242 30

N Y

X X Medical order X Nursing staff X Nursing staff

Sampling size

N

N

X X

X

Reliabilitya

Response rate (%)

Reference Davidson, Hemingway, and Wysocki (1984)

93

Davis, Cullari, Breuning (1982) Etherington, Sheppard, Ballinger, and Fenton (1995) Fernando, Regan, and Khwaja (1997) Fischbacher (1987) Gowdey, Coleman, and Crawford (1982)

N Y

509 1,250 981 967 934 1,389 139

Y

87

Harper and Wadsworth (1993)

Y

87

Harper, Wadsworth, and Michael (1989)

Gowdey, Zarfas, and Phipps (1987) Hancock, Weber, Kaza, and Her (1991)

X

X Case notes — Doctor and staff

X X X

X Staff X Nurse X Case manager

Y

N Y

60

Harvey and Cooray (1993)

101 Not known

Hemming (1984) Hill, Balow, and Bruininks (1985)

Y

169

Hughes (1977)

Y

466

Intaglia and Rinck (1985)

X State

N

35,007

Jacobson (1988)

X State database X

N

31,072

Jacobson and Ackerman (1993)

N N Y

596 520 488

X

X

199 X

X

X

X Nurse

91

Jonas (1980) Kiernan Reeves and Alborz (1995) Kohen, Matthew, and Fernando (1993)

(continued )

TABLE III (Continued ) Sampling procedures

Survey

Record review

Medical Agency Pharmacy chart record record

Ascertainment

Interview

X State database X X X

X

X

X Nurse

X X 200

X X X M.D. review X State database X

X

X

X

X Nurse X X

X X X

X

X Staff

Other

Reliabilitya

Sampling size

N

Not known

LaMendola, Zaharia, and Carver (1980)

N N Y

168 Not known 178

Linaker (1990) Lipman (1970) Martin and Agran (1985)

N Y N N N

21 355 369 474 223

N

3,744

Y

53

Y Y N N Y

648 260 585 1,056 3,789

Response rate (%)

Reference

Morgan and Gopalaswany (1984) Ono (1998) Pary (1993) Poindexter (1989) Rimmer, Braddock, and Marks (1995) Rinck and Calkins (1989)

Sachdev (1991) Sewell and Werry (1976) Silva (1979) Spencer (1974) Spreat and Conroy (1998) Spreat, Conroy, and Jones (1997)

X X Nurse X Nurse X Nurse X Nurse

X State database X

X X a

201

b

X

X

N

6,450

Stone, Alavarez, Ellman, Hom, and White (1989)

Y

64

N N

2,238 2,158

Tu (1979) Tu and Smith (1979)

Y

2,158

Tu and Smith (1983)

N

415

N N

983 1,282

Thinn, Clarke, and Corbett (1990)

White (1983)

70

Wressell, Tyrer, and Berney (1990) Zaharia and Struxness (1991)

Reliability was considered if stated explicitly or if there was more than one method of information gathering for the same information. Average numbers provided for sample size.

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researchers were limited by the capacity for the number of consumers in a setting; the number of individuals with disabilities residing in a designated area; the extensiveness of state or country’s database of service delivery for people with DD (not everyone was receiving services); and the number of surveys returned. In all, sample sizes varied from 21 to 35,007. Furthermore, the characteristics of the people in the samples varied significantly. Some studies included individuals with varying degrees of mental retardation, age ranges, gender, living settings, and target behaviors. Some studies had a particular target population or concern, such as the prevalence of psychotropic drug use among elderly individuals with MR/ DD or people with similar levels of functioning. Although specific information like this is important for examining patterns of medication use within these target groups, the overall task of analyzing the prevalence of medication use across the entire population of people with MR/DD becomes more difficult. 3. STATISTICAL PROCEDURES Statistical procedures employed to evaluate the relations between psychotropic medication use and characteristics of MR/DD population such as gender, age, level of retardation, and living setting also differed across studies. Of all the studies that evaluated and reported potential relations between psychotropic medication use and the characteristics listed, 75.6% of the studies identified the statistical procedure used. The most common analysis conducted—in 50% of the studies—was a simple 2 analysis. Variations of 2 analyses were also conducted and there were studies that conducted additional analyses. The second most commonly used analysis was multiple regression (19.6% of the studies). These studies considered interactions and covariates of characteristics. One study reported a level of significance for their findings but did not mention the statistical procedure employed (Kohen, Mathew, & Fernando, 1993). There were two studies that used control groups (Hemming, 1984; Jacobson, 1988). Finally, other studies asserted relations between characteristics of the population and psychotropic medication use, but did not conduct a statistical analysis to determine whether these relations were statistically significant (e.g., Fischbacher, 1987; Gowdey, Zarfas, & Phipps, 1987).

IV.

CONCLUSION AND FUTURE RECOMMENDATIONS

This literature review provided information regarding trends in the use of psychotropic medication with adults with DD. Patterns were observed in the

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research; e.g., between the years of 1975 and 1988 there was an increase in the number of prevalence studies conducted. This review also presented and examined the correlates and potential predictors of psychotropic medication use that had been identified by researchers from 1970 to 2000. Unfortunately, there was limited consensus on the variables, which were identified to be related either positively or negatively, and psychotropic medication use. A.

Utility of Current Information

Because several conflicting accounts were found for predictors and correlates of psychotropic medication use, and different prevalence figures were provided within each year, one might question the utility of the current information provided. It is possible that different outcomes for each study were achieved because of the variability of data within and across studies, which in turn may have decreased the power of predictive outcomes for these studies. There may still be value, however, to conducting prevalence studies and examining associated variables. For example, obtaining data on the number of individuals using psychotropic medication would provide caregivers and practitioners with a relative number of what is (or is not) appropriate. Data obtained from prevalence studies might provide insight into the current status of psychotropic medication use, but these figures inform the public only about what is occurring exclusively in that geographic area or setting at that particular time. There may be no way to determine or mandate what percentage of people with DD is an ‘‘appropriate’’ percentage to be using psychotropic medication. At best, using prevalence figures of this type could provide local and/or state regulating agencies with the knowledge and/or the basis for identifying situations that could potentially be ‘‘red flag’’ situations, possibly indicating the misuse of psychotropic medication as substitutes for habilitation, as punishment, or for the convenience of staff. While these quantitative measures are valuable for identifying potential psychotropic medication misuses, qualitative measures and information must also be gathered to identify instances where psychotropic medication is used appropriately or inappropriately. B.

Recommendations for Future Studies

In conducting prevalence studies, future studies should utilize a more concise and consistent methodology for sampling the population. For example, when possible, researchers should consider having more than one source for information. This may ensure the accuracy and completeness of data collected and address reliability issues. Second, researchers should take care to describe the representativeness of their sample and the sampling

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procedures. In describing their sample, researchers might address participant ascertainment and identify those individuals who are more likely to or who actually do respond and those who do not. In gaining this information, researchers could more accurately take into account all variables and characteristics that may influence or be associated with participation and medication use. The use of appropriate statistics is important in determining the significant relations and their strength between these variables, and characteristics, and psychotropic medication use. Finally, if at all possible, blind data collection would protect against researcher bias. As it currently stands, comparing specific point (e.g., outpatient clinic data, community agency data) prevalence data is difficult given the differences in methodology and the lack of details. However, if we as researchers can improve methodology and reduce the methodological differences involved in the collection of these data, comparisons of these data may become more useful. The area of DD needs more than just figures for predictors and correlates of psychotropic medication use conducted. Future research should examine variables associated with psychotropic medication use, and researchers should also include measures of medication compliance (are people actually administering and/or taking the medication), assess the use of psychotropic medication, and assess the purpose of psychotropic medication use. Empirical research should be conducted to determine the appropriate use of psychotropic medication. The question to be posed and scientifically answered is under what conditions is it appropriate to administer and/or to continue to administer medication, as opposed to providing other less restrictive and intrusive interventions? Monitoring targeted symptoms and behaviors for which medication is administered (i.e., aberrant behavior) and evaluating medication/behavior interactions are appropriate; however, they are not the sole measures of psychotropic medication efficacy. In a preliminary study, Jordan (1994), found that it is possible to provide information on medication/behavior interactions and side effects in a concise manner; however, further research on the joint evaluation of and monitoring of the effects of psychotropic medication on aberrant behavior and potential side effects is needed. C.

Best Practices

Until future research on the joint evaluation of the effects of psychotropic medication on aberrant behavior and potential adverse side effects is conducted, several professionals and researchers recommend that the decision to use psychotropic medication be made on an individual basis (i.e., Arnold, 1993; Manchester, 1993; see all studies cited in Section III,C,2). Upon deciding to use medication, caregivers and others involved in the

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decision-making process should use individualized methods for monitoring and evaluating psychotropic medication use. Several researchers have reported that using psychotropic medication monitoring systems increased the use of objective behavioral measures and interventions (i.e., Briggs, Hammad, Garrard, & Wills, 1984; Kalachnik, Miller, Jamison, & Harder, 1983). Practices that can be used in combination for evaluating and monitoring medication use and efficacy are (a) following federal, state, and community organization guidelines, (b) incorporating interdisciplinary teams, (c) conducting pharmacological evaluations (pharmacist involvement), (d) conducting behavioral observations, (e) utilizing rating scales and other methods for monitoring side effects, (f) utilizing psychopharmacological algorithms, and (g) implementing computer-based monitoring systems. 1. FEDERAL, STATE, AND COMMUNITY ORGANIZATION GUIDELINES Guidelines, enacted by different governing entities (i.e., federal/state governments, accrediting organizations, litigation), have provided agencies and caregivers with standards for providing adequate and proper care of people with DD in all areas of life, including the administration and monitoring of psychotropic medication. Unfortunately, it appears that while the guidelines set forth are extensive and protective of people with DD, they do not provide caregivers with instruction for delivering or implementing these standards (Kalachnik, 1988). Furthermore, in the past, there was some indication that these guidelines were followed more closely for individuals living in institutional settings than for those in the community (Rinck, Guidry, & Calkins, 1989). Rinck et al. (1989) postulated that perhaps this difference might have resulted from the community physicians providing care not necessarily following the same guidelines as those employed by the state institutions. Educating physicians on guidelines could prevent potential misuse in the prescription of psychotropic medication. Another solution for ensuring that community agencies comply with guidelines would be to prepare manuals that state these guidelines explicitly and provide agencies with the instruction or training to follow them (e.g., Heimerl, 1996) or to establish and implement quality assurance measures within each agency (Brasic et al., 1997). Several studies have shown that following monitoring guidelines has contributed to decreases in psychotropic medication use with people with DD (e.g., Bisconer, Zhang, & Sine, 1995; Briggs, 1989; Hancock, Weber, Kaza, & Her, 1991; James, 1983). More recent guidelines for the use of psychotropic medication are concerned with (a) how medication is used; (b) how medication is monitored to determine efficacy; (c) how and if potential adverse side effects are monitored; (d) how medication is administered and for how long; (e) how

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many medications are used at any given time (polypharmacy); (f) behaviors for which medications are being administered and how these behaviors are monitored; (g) concurrent medication use; and (h) documentation of information (i.e., Einfeld, 1990; Kalachnik, 1988; Kalachnik et al., 1998; Rinck, Guidry, & Calkins, 1989; Singh, Guernsey, & Ellis, 1992). 2. INTERDISCIPLINARY TEAMS Interdisciplinary teams appear to be a popular method for managing medication use. For example, in 1987 all but five states required that interdisciplinary teams decide on the use of psychotropic medications for behavior control (Rinck et al., 1989). The teams usually consist of any of the following combinations of people: psychiatrists, other physicians (e.g., internists), nurse practitioners, psychologists, behavioral specialists, social workers, pharmacists, nurses, agency administrators, case managers, directcare staff, consumers, family members, and advocates (Briggs, 1989; Briggs et al., 1984; Davis et al., 1998; Findholt & Emmett, 1990; Glaser & Morreau, 1986; Kennedy & Meyer, 1998; Lepler, Hodas & Cotter-Mack, 1993; Schalock, Foley, Toulouse, & Stark, 1985). It is important to note that the team’s duties are not limited to monitoring psychotropic medication use; however, when monitoring psychotropic medication use, the team’s purpose is to provide an accurate representation of the individual consumer’s behavior (Davis et al., 1998). Considering the duty of monitoring psychotropic medication use, Kennedy and Meyer (1998) recommended that the interdisciplinary team consider previous medical and medication history, current and previous behavioral interventions, target behaviors, least restrictive settings, factors important for a consumer’s quality of life, and support needs of the consumer. Kalachnik et al. (1983) found that when interdisciplinary teams are formed and used, documentation increases in both quantity and quality. Some researchers have argued that utilizing an interdisciplinary team approach leads to decreases in overall psychotropic medication use (Briggs, 1989; Findholt & Emmett, 1990; Jauering & Hudson, 1995; LaMendola et al., 1980; Lepler, Hodas, & Cotter-Mack, 1994; Schalock et al., 1985). In part, these reductions were due to the team’s recommendations for using behavioral interventions rather than psychotropic medication. However, it is possible that these results were due to confounding variables (e.g., changes in staffing, other environmental changes not recommended by the interdisciplinary team). 3. PHARMACOLOGICAL EVALUATIONS Although pharmacists are considered to be a part of the interdisciplinary team, special attention should be given to these team members because of

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the unique contribution they may bring. Pharmacists potentially have access to a database that provides complete medication histories: type and dose of medication, number of medications prescribed at any given time, and drug allergies. Furthermore, their curriculum includes drug/drug interactions and effects, potential side effects, and recommended dosages. Another benefit of having pharmacists on an interdisciplinary team is that they may be more available for questions and/or emergencies than physicians. A number of studies have been conducted that evaluated the effect of having a pharmacist on an interdisciplinary team, and results indicated that psychotropic medication use with people with DD decreased when a pharmacist was part of the team (i.e., Berchou, 1982; Ellenor & Frisk, 1977; Inoue, 1982; Marcoux, 1985). As with any study of this nature, however, it is possible that other variables not identified by the researchers may have confounded the results. 4. BEHAVIORAL OBSERVATIONS Several recommendations have been made on how behavioral observations should be conducted to monitor medication effects. One is preeminent: Target behaviors, when considered to be the primary reason for psychotropic medication administration, should be measured (i.e., Arnold, 1993; Huessy & Ruoff, 1984; Kalachnik, 1988; Kennedy & Meyer, 1998; Linscheid, Rasnake, Tarnowski, & Mulick, 1989). Depending on the resources available to an agency or caregiver, possible measurement techniques include frequency counts, duration recording, time sampling, interval recording, rating scales, evaluation of potential setting events and/ or establishing operations related to the occurrence of the target behavior (i.e., conducting functional analysis or assessments), and evaluation of physiological variables (e.g., sleep patterns or seizure occurrence) (Bailey & Pyles, 1989; Kalachnik, 1988; Kalachnik, Hanzel, Harder, Bauernfeind, & Engstrom, 1995; Kennedy & Meyer, 1998; Linscheid et al., 1989; Schaal & Hackenberg, 1994; Spirrison & Grosskopf, 1991). It is important to have conducted baseline measures of target behaviors so that these measurements track changes in behaviors that may be direct results of psychotropic medication administration. The information obtained while monitoring target behavior may provide caregivers with the data needed to determine when medication reductions should be conducted, possibly resulting in the titration or discontinuation of psychotropic medication use when medications are not effective (Singh & Winton, 1984). As mentioned, previously, rating scales are useful for collecting information on target behaviors. These tools are attractive because they do not take long to complete and the instruments have often been validated. Several scales exist for use with people with DD, including the aberrant

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behavior checklist (ABC) (Aman, Singh, Stewart, & Field, 1985a) and the self-injurious behavior questionnaire (SIB-Q) (Gualtieri & Schroeder, 1989). (For further information on the validity, reliability, and appropriateness of these instruments, refer to existing reviews of these instruments: Aman, 1991; Aman, Burrow, & Wolford, 1995; Aman, Singh, Stewart, & Field, 1985b; Bech et al., 1993; Hurley et al., 1998; Schroeder, Rojahn, & Reese, 1997; Sturmey, Fink, & Sevin, 1993.) Behavioral measures provide information on the potential positive or negative effects of psychotropic medication on target behavior, but preliminary data suggest that this information alone may not be sufficient to alter the medication prescription practices of a physician (Piper, 1990). For example, an individual may be emitting fewer instances of aberrant behavior because the individual is now sleeping all day. Thus, behavioral measures should also be accompanied by other information, such as the occurrence of adverse side effects. 5. RATING SCALES AND OTHER METHODS FOR MONITORING SIDE EFFECTS (AND ADVERSE DRUG REACTIONS) Just as there are rating scales to measure changes in target behaviors, there are rating scales to measure and monitor side effects (Lingjaerde, Ahlfors, Bech, Dencker, & Elgen, 1987). The more common scales used are those designed to measure tardive dyskinesia. These scales include the abnormal involuntary movement scale (AIMS) (NIMH, 1985), the dyskinesia identification system: condensed use scale (DISCUS) (Sprague, Kalachnik, & White, 1985), and the akathisia ratings of movement scale (ARMS) (Bodfish, Newell, Sprague, Harper, & Lewis, 1997). (For a review of other scales used to measure tardive dyskinesia, see Campbell & Palij, 1985, and Kalachnik, 1999a.) Other scales measure adverse side effects rather than specifically measuring tardive dyskenisia, such as the Matson evaluation of drug side effects scale (MEDS) (Matson et al., 1998) and the monitoring of side effects scale (MOSES) (Kalachnik, 1988). Rinck et al. (1989) recommended that professionals such as physicians and psychologists should conduct ratings to monitor potential side effects of medication. Kalachnik and Sprague (1994) noted that without formal training with these instruments and identifying side effects, the assessments completed by these professionals are not always accurate, unless raters were trained adequately (e.g., Sprague & Kalachnik, 1991; Sprague, Kalachnik, & Shaw, 1989). Even though rating scales are a popular method for measuring potential adverse drug reactions, they are limited because they may only detect side effects (Kalachnik, 1999a). Kalachnik (1999a) provided definitions of these

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two terms that are often confused. The term side effect refers to ‘‘undesirable, unintended, or unwanted reaction because of the known pharmacological effects of a [medication]’’ at a normal dose (p. 350). However, the term adverse drug reaction refers to events beyond the known pharmacological effects of a drug and those unintended, noxious effects experienced as a result of the use of a medication at normal doses, which include allergic reactions, idiosyncratic reactions, side effects, toxic reactions, and drug/drug or drug/food interactions. Whereas all side effects are adverse drug reactions, not all adverse drug reactions are side effects. Tests for measuring adverse drug reactions can be intrusive, sometimes requiring readministration of the medication hypothesized to be the cause of the reaction or tests that require blood analysis (Naranjo, Shear, & Lanctoˆt, 1992). In the past, developing other means for detecting and measuring adverse drug reactions reliably had been a difficult task given the subjective measures sometimes employed (i.e., Alvarez-Requejo et al., 1998; Karch et al., 1976; Kramer, Leventhal, Hutchinson, & Feinstein, 1979; Mahoney & Miller, 1991). Research continues to be conducted to develop less intrusive, reliable measures and training protocols for the detection of adverse drug reactions for use by clinicians and other staff of service delivery agencies (Hutchinson et al., 1979; Kramer et al., 1979; Mahoney & Miller, 1991; Mahoney, Miller, & Phillips, 1991; Naranjo et al., 1981; Naranjo et al., 1992). 6. PSYCHOPHARMACOLOGICAL ALGORITHMS Algorithms, which are often displayed as flow charts, have been developed for detecting side effects (e.g., Hutchinson et al., 1979), determining treatment options (e.g., Mikkelsen & McKenna, 1999), determining minimal effective doses (e.g., Kalachnik, 1988), and determining medication efficacy (e.g., Lepler et al., 1993). In one study, researchers found that the use of algorithms within an interdisciplinary team framework resulted in low rates of psychotropic medication use (Lepler et al., 1993). Until further research can produce definitive answers concerning the use of psychotropic medication for people with DD, algorithms can provide guidelines for caregivers on how to identify and determine the best treatment for consumers (Mikkelsen & McKenna, 1999). 7. COMPUTER-BASED MONITORING SYSTEMS As computers become more common in daily life, their use should also extend into the delivery of services for people with DD. Already, this technology is used to monitor behavioral data (e.g., Bluestone, 1995), and research has been conducted to develop means of using computer technology to monitor adverse drug reactions (e.g., Bate et al., 1998; Corso,

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Pucino, DeLeo, Calis, & Gallelli, 1992; Johnston, Morrow, & Branch, 1990; Koch, 1990). Preliminary findings suggest that while sometimes producing reports of effects that were not actually adverse drug reactions (Koch, 1990), the use of computerized monitoring systems often resulted in the detection of previously unreported adverse drug reactions (Bate et al., 1998; Johnston et al., 1990). Further, it is speculated that the use of computers will facilitate improved communication between caregivers and physicians because of the ease by which information can potentially be shared and summarized (Corso et al., 1992). In conclusion, the best practice that can be recommended for the evaluation and monitoring of psychotropic medication use with people with DD is to use as many as possible of the mentioned practices in combination to develop an individualized plan. The strength of any given system will not, and should not, be determined by the number of consumers on psychotropic medication, but rather by the quality of life afforded to each consumer, which includes the appropriate and efficacious use of psychotropic medication.

ACKNOWLEDGMENTS The authors gratefully acknowledge the thoughtful comments and suggestions to the manuscript made by Jennifer R. Zarcone, Jan B. Sheldon, and L. Keith Miller. This work was supported by NICHD Grants 26927 and HD02528.

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