PubMed Health⌕ Search

Biomedical subjects

J M Zito

Publications and source records attributed to J M Zito.

34 records · Page 2Linked to original sources

Neuroleptics in acute mania: a pharmacoepidemiologic study.

OBJECTIVE: To provide an epidemiologic descriptive analysis of the acute drug treatment of inpatients with bipolar mania in state psychiatric facilities in 1990. METHODS: We surveyed the first 3 weeks of drug treatment of all inpatients with bipolar mania who were admitted to 22 New York State adult psychiatric facilities during a 6-month period (n = 528). RESULTS: Almost all patients with mania were treated with neuroleptics. The mean +/- SD neuroleptic dosage was 684 +/- 543 mg/d chlorpromazine equivalents. Sixty-one percent of the patients received lithium and 12% received carbamazepine or valproate. Neuroleptic dosage was related to age, with older patients receiving lower dosages. Patients receiving combination treatment of a neuroleptic with either lithium, an anticonvulsant, or a benzodiazepine received a mean neuroleptic dosage similar to that of patients treated with a neuroleptic alone. CONCLUSIONS: Although their use has been widely discouraged for mood disorders, neuroleptics have been the standard treatment for acute mania.

Adult↗

Increased methylphenidate usage for attention deficit disorder in the 1990s.

OBJECTIVE: To estimate the increased use and the prevalence of methylphenidate (Ritalin) treatment of youth with attention deficit disorder (ADD) during the 1990s. DESIGN: Using time-trend findings from two large population-based data sources, three pharmaceutical databases, and one physician audit, a best-fit estimate of the usage and the usage trends for methylphenidate treatment over the half decade from 1990 through 1995 was sought. SETTING: Five regions in the United States (US) and the nation as a whole. PATIENTS: Youths on record as receiving methylphenidate for ADD. RESULTS: The findings from regional and national databases indicate that on average, there has been a 2.5-fold increase in the prevalence of methylphenidate treatment of youths with ADD between 1990 and 1995. In all, approximately 2.8% (or 1.5 million) of US youths aged 5 to 18 were receiving this medication in mid-1995. The increase in methylphenidate treatment for ADD appears largely related to an increased duration of treatment; more girls, adolescents, and inattentive youths on the medication; and a recently improved public image of this medication treatment. CONCLUSION: The database findings presented serve to correct exaggerated media claims of a 6-fold expansion of methylphenidate treatment, although they do not clarify the issue of the appropriateness of this treatment.

Adolescent↗

Pharmaceutical decisionmaking: pharmacoepidemiology or pharmacoeconomics--who's in the driver's seat?

Although it is well known that clinical trial findings and actual clinical experience can differ substantially in pharmaceutical decisionmaking, it is our working hypothesis that this divergence is critically important in the area of psychopharmacology. We support this contention with a discussion of recent findings from post-marketing pharmacoepidemiologic and pharmacoeconomic investigations of clozapine. The pharmacoeconomic evaluations purport to show cost savings of clozapine versus standard neuroleptic therapy but these conclusions are flawed, in large part because the epidemiologic investigations on which they are based are inadequate. To correct this situation, long-term, randomized field trials (usual practice settings) are needed to compare costs and outcomes of clozapine versus standard therapy. The design of these studies should incorporate multidimensional outcomes, including social function, employment, and rehospitalization, as well as measures of symptoms and self-reported quality of life. Pharmacoeconomic evaluations that adopt the designs of typical clinical trials with limited outcome measures, such as symptoms or self-reported quality of life measures, will not be sufficient to determine cost-effectiveness for psychopharmacologic therapies of severe mental disorders.

Decision Making↗

Pharmacoepidemiology of clozapine in 202 inpatients with schizophrenia.

OBJECTIVE: To evaluate clozapine in a field trial for hospitalized patients with treatment-resistant schizophrenia. METHOD: The setting consisted of a large, state-operated, public psychiatric system. The protocol called for the treating psychiatrist to provide symptom- and adverse-effect ratings at four times following the start of drug therapy. The outcome criteria included the Sandoz study outcome measure of symptom improvement as well as discharge status for one year of follow-up. To assess the validity of the ratings, several measures of internal consistency were determined. Clozapine therapy was started in 227 patients, and symptom data are available for 202. RESULTS: Overall, 33 percent (n = 66) of the patients were improved at the end of one year of treatment; 12 percent (n = 24) maintained symptom improvement at all three evaluation times. Modest, statistically significant improvement after 12 weeks compared with baseline Brief Psychiatric Rating Scale (BPRS) total scores was observed for the patients continuing medication (n = 152); the emergence of a previously unimproved group (n = 26) explains this modest improvement. However, in the analysis of all patients (n = 202), (including dropouts), there was no significant symptom improvement after 12 weeks. Lower baseline BPRS scores predicted significant symptom improvement after 12 weeks of treatment. Among those medicated for one year, the pattern of symptom improvement showed that the probability of late improvement was 0.26 for those previously unimproved, and the probability of a 12-week responder losing improvement was 0.23, resulting in a net group gain of 3 cases in 100. By the end of one year, 8 percent (n = 17) of the cohort was discharged, and 3 percent (n = 7) was transferred to another facility while continuing to receive clozapine. Of the 227 original patients started on clozapine therapy, medication was discontinued for adverse effects in 11 percent (n = 25): white blood cell count (WBC) decrease (but no agranulocytosis) in 5 percent (n = 12), seizures in 1 percent (n = 3), one patient with seizures and decreased WBC count, and other events (e.g., cardiovascular changes, fever, or possible neuroleptic malignant syndrome) in 4 percent (n = 9). Patient refusal was reported for 6 percent (n = 13) of those starting treatment. CONCLUSIONS: Although only 19 percent of the patients exhibited improvement at 6 weeks, the response rate at 12 weeks (29 percent) for this naturalistic study cohort was similar to that in the major, double-blind, six-week, controlled, clinical trial of clozapine. The impersistence of response as symptoms were followed for up to one year is a finding that deserves rigorous evaluation.

Adult↗

New York under the Rivers decision: an epidemiologic study of drug treatment refusal.

OBJECTIVE: To determine the characteristics of cases of drug treatment refusal under the Rivers decision, which mandated court adjudication of such cases, the authors made a retrospective study of all applications for court review during 1 year in New York State inpatient facilities. METHOD: Sociodemographic and clinical characteristics of these 473 cases were compared with those of the 41,535 cases during the same period in which no court review was requested. RESULTS: A 1% prevalence of applications requesting court review for nonemergency administration of medication over objection was found. The patients who refused medication were more likely than the comparison patients to have a crime-associated commitment status, a diagnosis of schizophrenia, and fewer previous hospital days, and they were more likely to be discharged. Medication refusers for whom applications for court review were submitted had relatively longer hospitalizations than the rest of the patients. Almost one-third of the applications submitted were withdrawn before court hearings, yielding a 0.7% prevalence of court-reviewed applications. Ninety-two percent of these applications for medication over objection were approved with virtually no change in the requested orders. CONCLUSIONS: The study findings demonstrate that a front-end judicial determination of competency to refuse medication results in a time-consuming procedure which fails to ensure real due process or provide individualized alternative treatment. A two-tier system with in-house clinical review preceding judicial review is proposed to remedy the deficiencies of the current system.

Commitment of Persons with Psychiatric Disorders↗

Creating a supportive environment using staff psychoeducation in a supervised residence.

The prevailing approach to rehabilitation in residential care emphasizes goal attainment. This approach often produces considerable stress for residents, most of whom have schizophrenia. Based on the view that low-demand environments, incorporating graduated expectations, may be more appropriate for this patient population, a three-component model for creating and maintaining a calm, supportive environment in a supervised residence was developed. The model utilizes staff psychoeducation, which is based on the principles of family psychoeducation, a highly effective intervention for patients with schizophrenia. The three components of the model are training in supportive interaction, a medication-monitoring program, and a behavioral approach to problem solving. Resident groups promote each of these components. The groups' goals are encouragement of positive, low-key interactions, compliance with medications, and slow, steady rehabilitation.

Adult↗

Self-reported neuroendocrine effects of antipsychotics in women: a pilot study.

Although neuroendocrine adverse effects (NAEs) of antipsychotic agents in women have been widely reported, it has been generally assumed that either (1) tolerance to these effects develops with chronic use, (2) patients adjust to the effects, or (3) a trial of dopamine-agonist treatment is effective. We have begun to examine the prevalence of chronic adverse effects and their effect on compliance using a pilot study of self-reported NAEs, antipsychotic drugs, and compliance patterns in a naturalistic setting. Twenty chronic psychiatric outpatients who had been continuously prescribed antipsychotic agents for a minimum of six months were interviewed. The major finding is the greater antipsychotic dose exposure among those with self-reported NAEs compared with those without NAEs (781 +/- 606 chlorpromazine-equivalent mg/d vs. 125 +/- 117, p less than 0.001). High-potency agents were prescribed for all of the patients reporting amenorrhea and/or galactorrhea, although the relationship between potency group (high vs. low) and total neuroendocrine effects was not significant. Self-reported compliance was not significantly related to neuroendocrine adverse effects. However, a trend toward the association of self-reported galactorrhea and noncompliance (p = 0.08) is noted. The implications of these findings and a suggested approach for their replication in a more powerful statistical analysis is discussed.

Adult↗

Pharmacoepidemiologic methods for identifying and quantifying behavioral effects of neuropharmacological agents.

The possibilities and limitations of the pharmacoepidemiologic methods of determining neuropharmacologic drug efficacy and safety in psychiatric patients are discussed in this review. Such methods can improve both the scientific evaluation and clinical practice aspects of our knowledge of these drugs by providing: (1) incidence rates of drug usage and adverse events from computerized information on large populations; (2) quantitative methods for risk-to-benefit assessments that incorporate multiple outcome measures, provide long-term effectiveness and safety data, and use statistical methods to distinguish drug-induced from illness-based behaviors; and (3) systematic epidemiologic approaches to resolving dilemmas that involve the political and social context in which neuropharmacological drugs are used.

Behavior↗

Pharmaco-epidemiology in 136 hospitalized schizophrenic patients.

The authors surveyed pharmacotherapy in a group of 136 newly admitted patients with a DSM-III diagnosis of schizophrenia. They found that nine antipsychotic agents were used; the median daily dose (in chlorpromazine equivalents) was 1088 mg (mean +/- SD = 1428 +/- 1260 mg; range = 75-6186 mg). Women received greater mean daily doses of antipsychotics than men (1688 versus 1284 mg). Using a Cox model survival analysis, the authors found no statistical association between length of stay and the mean daily dose of antipsychotic medication. The mean daily dose of high-potency agents was 2.7 times greater than the dose of low-potency agents. The excess exposure to haloperidol alone resulted in 16.3% of the overall neuroactive drug costs.

Adolescent↗

Clinical characteristics of hospitalized psychotic patients who refuse antipsychotic drug therapy.

Thirty psychotic patients who refused antipsychotic medication were compared with 30 patients matched for age, sex, treatment ward, commitment status, and diagnosis who consented to drug treatment. Refusers were no more assaultive or combative than consenters; they were less often diagnosed as having schizophrenia and more often diagnosed as having bipolar or schizoaffective illness. A comparison between 17 of the least symptomatic refusers and 17 of the most persistent refusers showed that persistent refusers were more likely to have a diagnosis of schizophrenia; least symptomatic refusers were more often diagnosed as having affective disorders or schizoaffective disorders.

Adult↗

Pharmacotherapy of the hospitalized young adult schizophrenic patient.

The authors surveyed pharmacotherapy in a group of hospitalized 18 to 35-year-old young adult patients (N = 286) with a DSM-III diagnosis of schizophrenia. Drug use comparisons were made between patients with a 180 day or less hospitalization (short-stay, N = 226) and those with a 366+ day hospitalization (long-stay, N = 60). Psychotropic drug usage during the initial 180 and most-recent 180 days of treatment of the long-stay group was compared with the total episode of the short-stay group. Antiepileptic, antidepressant, lithium and anxiolytic/sedative/hypnotic agents, were used in significantly more of the long-stay than short-stay patients. This increase was not observed between the two groups for the initial 180 days of the long-stay group but was observed during the most recent 180 days of treatment. Antipsychotic mean daily doses and patterns of use in the two length of stay groups were similar. Chlorpromazine (CPZ) dosage was significantly increased in long-stay patients compared with short-stay patients (P less than .05).

Adult↗

Building pharmacoepidemiological capacity to monitor psychotropic drug use among children enrolled in Medicaid.

This study's objective was to develop a methodology to apply pharmacoepidemiological research toward understanding and improving psychotropic drug use among children enrolled in Medicaid. Using Kansas Medicaid data for 1995-1996, we summarized drug claims, diagnoses, and demographics for children under 20 who received at least one psychotropic drug prescription over either year. The sequence of steps needed to assure a quality improvement role is discussed. Use of key personnel in less regulatory and more clinical data applications is critical. Illustrating this approach, we found disproportionate numbers of children receiving psychotropic drugs who were young boys and larger numbers of white children receiving psychotropic prescriptions relative to their Medicaid enrollment than either African-American or Hispanic children. Medicaid agencies can expand epidemiological capacity to understand service use among segments of the population they insure as part of an overall commitment to improving quality.

Adolescent↗