Brock G. Guernsey

Pharmacists' Dispensing Accuracy in a High-Volume Outpatient Pharmacy Service: Focus on Risk Management:

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 < 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.

Successful treatment of chronic idiopathic urticaria and angioedema with cimetidine alone.

We have studied a 50-year-old white man with chronic urticaria and angioedema who has responded to treatment with cimetidine alone for over 2 yr. In a double-blind, placebo-controlled study, cimetidine alone was at least as effective as chlorpheniramine in relief of urticaria and angioedema. Additionally, cimetidine significantly inhibited (p less than 0.01) the wheal response to histamine when it was compared to placebo. The inhibition of wheal response to histamine by cimetidine was significantly higher (p less than 0.05) than chlorpheniramine. The presence of predominantly H2- rather than H1-histamine receptors in the cutaneous blood vessels may be responsible for the therapeutic effects of cimetidine in this patient.

Short- and Long-Term Effects of Auxiliary Labels on Patient Knowledge of Precautionary Drug Information

The purpose of this study was to determine the efficacy of auxiliary prescription labels in educating outpatients about medicines at two different time periods. Five hundred fifty-nine patients were randomly assigned either to an experimental group or a control group; each person in the experimental group received a prescription bottle to which one study auxiliary label (“sticker”) had been affixed, and those in the control group received bottles with no study sticker attached. Patients were interviewed by telephone approximately one week or two months after prescription pick up. Patients who had the study sticker affixed to their prescription bottle were significantly more knowledgeable after one week about precautionary information than those patients who did not receive stickers; however, sticker-group patients receiving the delayed interview incorrectly attributed many precautions to their medication. This is the first controlled study to document that auxiliary labels increase short-term knowledge about medications, and to suggest that the same labels may result in an inappropriate generalization over time.

Intravenous immune globulin therapy. Treatment of a patient with severe immunodeficiency, chronic malabsorption, and fulminant septicemia

Biweekly 200 mg/kg infusions of immune globulin (Gamimune) were given to a 46-year-old woman with severe common variable immunodeficiency, bronchiectasis, and chronic diarrhea with malabsorption. Failure to achieve therapeutically effective serum IgG concentrations in the face of fulminant sepsis was accompanied by a shortened serum IgG half-life of 10.6 days. Currently recommended doses of 200 mg/kg may prove inadequate in very ill patients with sepsis and malabsorption.

The feasibility of barcode-based dispensing quality assurance programs.

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 hospitals 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.

Book Review: Methodology of Clinical Drug TrialsMethodology of Clinical Drug Trials By SprietAlain and SimonPierre Published by S. Karger AG, Basel, Switzerland, 1985. Hardbound, 236 pp. (18 × 24.5 cm),

The first characteristics the reader will notice about this text are the concise manner in which it is written and the deliberate attention given to readability and comprehension. The book is prefaced with remarks by Louis Lasagna and in agreement with his observations, I would recommend the volume to anyone planning to conduct or presently engaged in the performance or analysis of clinical trials. The authors represent both the pharmaceutical industry and academic pharmacology. The mix of their individual backgrounds and experience has produced a text of very practical information pertaining to the planning, design, execution, and analysis of clinical studies. This text would be useful to the novice investigator as an easy-to-read and understandable primer and could serve the accomplished researcher as a handbook or desk reference. The book is 236 pages long and composed of 20 chapters. The final two chapters are both curious and unique for a text of this type. The last chapter is a word/topic index that facilitates rapid location of specific issues in the book. The chapter prior to the index is a very comprehensive checklist designed to troubleshoot all the important aspects of study design and analysis that should be present in a complete clinical protocol. The protocol checklist is an extremely practical addition to the overall presentation. The body of the text is well organized and sufficiently subdivided into chapters to allow proper focus of discussion. The real strength of the text is its clarity and use of example. The topics addressed include formulation of the research question, patient/subject selection, treatment assignment, response criteria, single and double-blind studies, placebos and placebo effects, choice of treatment modalities experimental design, sample attrition, patient compliance, collection of data and case report forms, cooperative/multicenter trials, analysis of data, choice of sample size, ethics and subject/patient consent, and prediction of treatment outcomes. It is not difficult to appreciate the completeness of the topic outline. The discussion of the individual topics is also exemplary. For example, the authors have clear presentations of sequential designs, the effects of treatment period-time interactions on interpretation of results in crossover trials, and a thorough overview and discussion of appropriate statistical techniques. These are topics that are generally not presented or presented at a level too remedial or too advanced for the average reader to adequately comprehend. Spriet and Simon have done a commendable job. The book has been translated from French; this is the first edition in English. Although this first edition still contains a few typographical errors, they do not detract from the very useful and practical information contained in the volume. The text might be useful as a classroom tool for teaching design and execution of clinical trials; however, its real value is as a practical handbook and reference for those who conduct clinical research in academics, institutional or private practice, or the pharmaceutical industry.

39.25.

A case of multiple-drug-resistant pulmonary tuberculosis (TB) is presented. The patients refusal to complete a course of drug therapy culminated in numerous relapses, treatment failures, and finally, death. Noncompliant drug behavior is probably the major cause of treatment failure. Supervised intermittent and short-course regimens can be utilized when patients demonstrate poor cooperation in self-medication programs. Resistance to first-line agents complicates retreatment of TB. Drug selection in these cases should be based on the results of sensitivity studies, and effective regimens frequently require the use of more toxic secondary agents. Although published guidelines for appropriate treatment of TB are available, inappropriate therapy continues to occur. Resistant organisms can be transmissible and virulent, and patients infected with them may serve as infector pools that produce new cases of primary resistance. The control of resistant TB depends on our ability to identify these individuals and to insure that they comply with effective drug regimens.