How well can patients discriminate drug-related side effects from extraneous new symptoms?
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Biomedical subjects
Publications and source records attributed to S G Bryant.
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As part of a large-scale ongoing project exploring new pharmacy-based methods of postmarketing surveillance, we are comparing a patient-initiated monitoring system to a staff-initiated approach. Here we report data only from staff-initiated, computer-directed telephone interviews with 231 outpatients approximately 2 weeks after they had been prescribed a target drug chosen from two markedly different pharmacological classes for which adverse drug reactions (ADRs) are well-documented. Our results indicate that spontaneous patient reports of "new or unusual symptoms" obtained from a standardized staff-initiated telephone interview can be quite reliable, leading to accurate detection of known tricyclic antidepressant and antibiotic ADRs.
The effects of 100 mg of phenytoin on the topographic distribution of augmenting/reducing (amplitude response/nonresponse to increases in stimulus intensity) of the visual N100 component of the event-related potential (ERP) were examined. In normal subjects, visual N100 augmenting is associated with impulsivity and attentional distraction. Effects of phenytoin on the topographic distributions of the P300 and slow-wave cognitive ERP components were also examined. Subjects counted the total number of light flashes presented at two highly discriminable but equiprobable intensities. Results indicated that phenytoin had a significant reducing effect on the intensity response of N100 at the vertex and anterior temporal electrode sites, and approached significance at the frontal pole. That is, at these loci N100 showed less of an increase in amplitude (or, in some subjects, more of a decrease) in going from baseline to drug than in going from baseline to placebo. Results also indicated that phenytoin significantly enhanced the amplitude of the frontal, negative portion of slow wave, but not the posterior, positive portion or the P300 component. These findings are consistent with behavioral evidence that phenytoin reduces impulsivity and improves concentration.
Educators in psychiatry face an important challenge in deciding what quantitative skills to teach and where in the educational agenda to teach them. One strategy is to focus the quantitative training of psychiatrists on techniques they need to be effective consumers of their literature. The authors catalogued the statistical methods described in 15 major psychiatric journals during 1983 and 1984. A dozen procedures, typically encountered in intermediate-level statistics courses, accounted for approximately 95% of all the statistical methods reported. Readers of psychiatric journals also routinely encounter multivariate, nonparametric, and categorization techniques. Educators might apply these results in designing exposure to statistical skills for future psychiatrists.
The epidemiology, pathophysiology, diagnosis and clinical features, and treatment of unipolar (depressive) and bipolar (manic-depressive) affective disorders are described. Disturbances of mood are the most common psychiatric disorders in adults, with 18-23% of women and 8-11% of men having at least one major depressive episode. Genetic factors are important in both depression and manic-depressive illness. Depression is characterized by a persistent dysphoric mood accompanied by feelings of sadness or hopelessness nearly every day for at least two weeks. The essential feature of a manic episode is an elevated, expansive, or irritable mood associated with symptoms such as hyperactivity and lack of judgment. Treatment involves nonpharmacologic and pharmacologic interventions. Psychotherapy in patients with depression is most useful in improving social functions, while antidepressant drugs reduce relapse rates. Electroconvulsive therapy is indicated in depressed patients at immediate risk of suicide or extreme incapacitation. Tricyclic antidepressants (amitriptyline, imipramine, doxepin, notriptyline, desipramine, trimipramine), second-generation antidepressants (maprotiline, amoxapine, trazodone, bupropion), monoamine-oxidase inhibitors (phenelzine, isocarboxazid, tranylcypromine, pargyline), and lithium are useful in treating patients with affective disorders. Tricyclic agents are the mainstay of treatment for depression; newer second-generation agents should be used in specific subgroups of patients. Lithium is the drug of choice for prophylaxis in bipolar patients, whereas combinations of lithium and tricyclic agents are useful during acute episodes of depression in bipolar patients. Major affective disorders occur commonly and require a careful balance of pharmacologic and nonpharmacologic interventions for proper therapy.
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As one facet of a larger investigation evaluating the various means by which patients receive information concerning their medications, a telephone-based drug information service was established for selected public use. The purpose was to detail the growth and utilization of the service, characterize the type and importance of the questions asked, and compare the potential utility with that of the USP-DI patient package insert (PPI) in responding to the public's drug information requests. Availability of the toll-free number for the Prescription Drug Information Service (PDIS) was controlled by offering it only to outpatients receiving selected medicines from the pharmacy of a large university-based medical center. The PDIS was operated by clinical pharmacists who participated in completing standardized operational data forms after each drug information call by the public. Of those calls received, 91.7% were not of a serious nature and most commonly dealt with side effects, drug interactions, and drug identification. Fifty percent of first-time calls occurred within two days of the subject's visit to the pharmacy and 23.4% of the total PDIS calls were repeat contacts. Interestingly, 34% of the patients' questions could not have been answered using the standard USP-DI PPI.
The attitudes of hospital pharmacists in Texas toward mental health care, psychiatrists, and mentally ill patients were evaluated. The pretested survey instrument contained 33 statements, which the respondents graded on a five-step Likert scale. These questionnaires were mailed to a random sample of 300 pharmacists. In general, the 170 respondents perceived psychiatrists and mentally ill patients in a positive manner. The psychiatrist was viewed as a true professional with legitimate expertise, and mentally ill patients were considered to be basically similar to normal individuals, generally rational, nondangerous, and without blame for their disease. The pharmacists showed more negative attitudes toward hospitals for mentally ill patients. They supported statements that depicted mental hospitals as understaffed, too drug oriented, and at times insensitive to individual needs. The surveyed hospital pharmacists generally demonstrated healthy, unprejudiced views toward psychiatrists and mentally ill patients; however, their attitudes toward mental hospitals were skewed in the negative direction.
A study was conducted to evaluate the feasibility of using barcodes in an outpatient pharmacy quality assurance program. In the first step of this study, adhesive labels containing a barcode representation of the National Drug Code (NDC) identification for the hospital's formulary medications were printed for each stock bottle or drug package used in dispensing. When an outpatient prescription was presented to the pharmacist, a label containing a barcode representation of the NDC identification for the prescribed medication was generated on-line and attached to the back of the prescription form. After the prescription item was filled by the pharmacist, an automated check was performed with a scanning wand by comparing the barcode on the prescription with the previously generated barcode on the stock bottle or drug packaging. A match indicated that the correct medication had been dispensed. Elaborations on this basic automated system for a barcode-based dispensing quality assurance program are suggested.
Use of the theophylline assay was reviewed for two months in 121 hospital inpatients who received 426 evaluations at a university medical center. Clinicians adapted published audit criteria for the collection and use of theophylline assays. The charts of all patients receiving theophylline were examined daily, and the following data, among others, were collected: pulmonary function tests, arterial blood gases, liver function tests, vital signs, and physician assessments. Only 29.8 percent of the evaluations complied with all criteria. When the audit categories of rational indication, correct performance, and appropriate dosage adjustment were evaluated independently, compliance rates were 69.1, 72.3, and 67.2 percent, respectively. In 171 cases (48.6 percent), the physicians' instructions for the assay were inadequate to ensure proper collection time by the phlebotomist. Hospital laboratory charges for unnecessary, incorrectly performed, or inappropriately used theophylline assays were estimated to exceed +77000 annually. This audit demonstrates the need for a collaborative pharmacokinetics service with reimbursement through the physician billing charge.
A review of digoxin assay utilization concurrent with patient hospitalization was conducted at the University of Texas Medical Branch. An interdepartmental committee of clinicians adapted audit criteria for the collection and use of digoxin assays. This included rational indications, correct performance (i.e., collection and processing of serum sample) and appropriate dose adjustment. The charts of all patients receiving digoxin were examined daily, whether or not the physician had ordered a drug assay. Contributory data were collected and analyzed, including serum electrolyte concentrations, arterial blood gases, renal function tests, vital signs, physician assessments, and other information relating to pertinent and concomitant diseases or drug therapy. The 2-month review included 104 hospital inpatients who received 245 evaluations. Only 38.4% of the evaluations were determined to be compliant with all criteria. When the audit categories of rational indication, correct performance, and appropriate dosage adjustment were evaluated independently, compliance rates were 66%, 73% and 86%, respectively. In 108 cases (52%), the physicians provided inadequate instructions in their request for the digoxin assay to insure proper collection time by the phlebotomist. Approximately 94% of all assay results were verbally communicated to the physician or returned to the patients' charts for use in patient management within a minimum of 24 hours. Hospital laboratory charges for unnecessary, incorrectly performed, or inappropriately used digoxin assays were estimated to exceed $100,900 annually. The audit was used to demonstrate the need for changes in hospital procedures and house staff training. A collaborative pharmacokinetics service was organized with reimbursement accomplished through the physician billing charge.
Hospital pharmacy residents participated in a program designed to introduce them to computer systems useful in pharmacy practice and to provide them with access to a variety of computer resources that could be helpful in completing their residency projects. Using existing computer facilities, various short courses and individual tutorials were employed to train residents in a variety of computer skills. These courses provided a useful vehicle for recent pharmacist graduates to acquire necessary computer skills not obtained during their academic training. Because the program provided residents with the tools needed for the management and analysis of large data sets, a marked increase occurred in the number of residency projects acceptable for publication in peer-reviewed pharmacy journals. Thus, residency projects improved in quality and faculty preceptors were more motivated to get involved in such projects.
A 12-day peer-review audit was performed in the outpatient pharmacy of a large teaching hospital. The audit process was not masked, that is, the pharmacists were aware of the peer-review evaluation. During the 12-day period, 9394 prescription forms and their corresponding pharmaceutical products were examined manually before being delivered to the patient. A total of 1165 (12.4 percent) dispensing errors were detected, with 141 (1.5 percent) of these considered potentially serious. Seventy-six prescriptions contained two errors and four prescriptions contained three. A linear relationship (r2 = 0.78; p less than 0.001) existed between the number of potentially serious errors and the total number of prescriptions filled. There were no statistically significant differences in the dispensing-error rate for the eight pharmacists audited. There was a trend for the number of pharmacist-hours containing at least one potentially serious dispensing error to increase as the prescription-filling rate accelerated. Outpatient pharmacies with high volumes should set a limit to the number of prescriptions filled by their pharmacists and should experiment with quality assurance systems to reduce dispensing errors and subsequent legal liabilities.
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