Low frequency of side effects following an incidental 25 times concentrated dose of yellow fever vaccine.
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In August/1999, a group of 14 adults from the staff of a private hospital in Contagem - Minas Gerais State, Brazil, received unintentionally a 25 times concentrated dose of the 17-DD yellow fever vaccine (Bio-Manguinhos), due to a mistake at the reconstitution step. All patients were clinically and laboratorially evaluated at days 5, 13 and 35 post vaccination. Frequency of side effects and clinical observations of this group of individuals were not different from the observed in recipients immunized with normal doses of the vaccine. At the second and third evaluation none of the subjects reported symptoms. None of the patients presented abnormalities at the physical examination at none of the time points and in all cases the blood examination was normal, except for a reduced number of platelets that was detected in one subject at the first and second evaluation and reverted to normal at third evaluation. At the first evaluation point, 8 subjects were serum negative and 6 serum positive for yellow fever at the plaque reduction neutralization test. In 5 subjects the observed titre was 10 times higher as the baseline of 2.36 Log10 mUI/ml. The samples collected at second and third evaluation (13th and 35th days) demonstrated that all subjects responded to the vaccination with the exception of one that did not present a positive result in any of the samples collected. This evaluation confirms the safety of the 17-DD yellow fever vaccine. (+info)
Implementing a new drug record system: a qualitative study of difficulties perceived by physicians and nurses.
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OBJECTIVES: To identify organisational difficulties faced by physicians and nurses when using drug prescribing sheets for recording both drug prescriptions and drug administration. DESIGN: Qualitative interview study. SETTING: Two general internal medicine wards. PARTICIPANTS: Seven physicians and eight nurses. MAIN OUTCOME MEASURES: Difficulties explicitly identified by the participants during the interviews. RESULTS: The implementation of procedures conflicted with existing structure, culture, and routines. Insufficient competence within the system to use the drug prescribing sheets created resistance and made people down the line create their own interpretations and solutions to the problems they faced. A total of nine problems were identified: (1) insufficient knowledge and uncertainty about procedures, (2) ignorance of sources of error, (3) unclear responsibilities, (4) low community spirit, (5) insufficient communication, (6) clinician autonomy and low acceptance of change, (7) strong professional identity, (8) low priority task, and (9) logistical problems. CONCLUSIONS: Unawareness of procedures, insufficient dissemination of knowledge, and insufficient cooperation and skepticism among those who put drug handling into practice is likely to have an impact on the quality of health care. The identification of these obstacles may help managers to improve the quality of the drug handling process on internal medicine wards and make it possible to select a framework for changing the clinical behaviour of doctors and nurses. (+info)
Should we consider non-compliance a medical error?
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Non-compliance is an extensive intractable problem. This paper argues that we can gain significant insight into non-compliance if we apply theories developed to explain human error in organisations. The resultant framework encompasses intentional and unintentional non-compliance, shifts blame from the patient, and recognises the influence of other factors, including organisational ones. There are also consequences for the measurement of compliance and new strategies to improve it. Terminology will need to be addressed, particularly whether intentional non-compliance by a patient should be considered an error. If empirical research supports the arguments in this paper then, with some further theory development, the application of human error theory will offer a useful new approach to understanding and reducing undesired non-compliance. (+info)
OBJECTIVE: To describe the process that is being undertaken to validate a series of indicators for preventable drug-related morbidity - originally developed in the US - for application in the UK health care system. DESIGN: A two-round Delphi questionnaire survey after a preliminary validation of the indicators within the University of Manchester School of Pharmacy. SETTING: A primary care study set in the UK. STUDY PARTICIPANTS: A purposively selected sample of general practitioners with a specific responsibility for prescribing-related issues (n = 6) and pharmacists actively involved in medication review in primary care (n = 10). MAIN OUTCOME MEASURES: The establishment of consensus among the participants that an indicator reflected preventable drug-related morbidity in primary care. RESULTS: After preliminary validation, 37 of the original 57 US indicators were retained. The Delphi panel generated 16 additional new indicators in the first round. At the end of the second round, the pre-defined level of consensus was reached for 29 indicators (19 of the US generated indicators; 10 generated by the panel in the first round). CONCLUSIONS: The Delphi results highlighted differences in both the clinical perspective and, possibly, philosophical viewpoints of health professionals practising in the UK and US health care systems. Further work, located in both primary and secondary care, is now in progress to operationalize the indicators. This process will form a key part of the refining, and hence further validation, of the indicators. The future development of prospective medical-record-based indicators should facilitate a reduction in the human, clinical, and economic burden of drug-related morbidity. (+info)
Computerized physician order entry systems in hospitals: mandates and incentives.
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Concerns with health care quality and medical errors are evident in media reports and research studies. A number of studies have demonstrated that computerized physician order entry (CPOE) can reduce medication error rates. In response, the California government and the Leapfrog Group have called for hospitals to implement CPOE for medications. However, few hospitals now use CPOE. Barriers include the large investment needed and the state of commercial CPOE systems. We argue that government, employers, and insurers should share the costs of CPOE and should fund further research into its benefits and means of implementation. (+info)
Challenged to care: informal caregivers in a changing health system.
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This report is from a 1998 national survey of 1,002 informal caregivers. Each year 23 percent of Americans provide unpaid assistance to ill, disabled, or elderly persons. Most caregivers (71 percent) do not live with care recipients. Primary caregivers provide more care of all types. Nonprimary caregivers also provide substantial care and services. Caregivers perform complex medical tasks, including medication administration, and errors can result. Few receive assistance from paid professionals or aides because of quality or financial concerns. In many areas, support and instruction could lighten caregivers' burdens and help to ensure high-quality care at home. (+info)
CONTEXT: Prescribing errors involving medication dose formulations have been reported to occur frequently in hospitals. No systematic evaluations of the characteristics of errors related to medication dosage formulation have been performed. OBJECTIVE: To quantify the characteristics, frequency, and potential adverse patient effects of prescribing errors involving medication dosage forms. DESIGN: Evaluation of all detected medication prescribing errors involving or related to medication dosage forms in a 631-bed tertiary care teaching hospital. MAIN OUTCOME MEASURES: Type, frequency, and potential for adverse effects of prescribing errors involving or related to medication dosage forms. RESULTS: A total of 1,115 clinically significant prescribing errors involving medication dosage forms were detected during the 60-month study period. The annual number of detected errors increased throughout the study period. Detailed analysis of the 402 errors detected during the last 16 months of the study demonstrated the most common errors to be: failure to specify controlled release formulation (total of 280 cases; 69.7%) both when prescribing using the brand name (148 cases; 36.8%) and when prescribing using the generic name (132 cases; 32.8%); and prescribing controlled delivery formulations to be administered per tube (48 cases; 11.9%). The potential for adverse patient outcome was rated as potentially "fatal or severe" in 3 cases (0.7%), and "serious" in 49 cases (12.2%). Errors most commonly involved cardiovascular agents (208 cases; 51.7%). CONCLUSIONS: Hospitalized patients are at risk for adverse outcomes due to prescribing errors related to inappropriate use of medication dosage forms. This information should be considered in the development of strategies to prevent adverse patient outcomes resulting from such errors. (+info)
Evaluating the capability of information technology to prevent adverse drug events: a computer simulation approach.
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BACKGROUND: The annual cost of morbidity and mortality due to medication errors in the U.S. has been estimated at $76.6 billion. Information technology implemented systematically has the potential to significantly reduce medication errors that result in adverse drug events (ADEs). OBJECTIVE: To develop a computer simulation model that can be used to evaluate the effectiveness of information technology applications designed to detect and prevent medication errors that result in adverse drug effects. METHODS: A computer simulation model was constructed representing the medication delivery system in a hospital. STELLA, a continuous simulation software package, was used to construct the model. Parameters of the model were estimated from a study of prescription errors on two hospital medical/surgical units and used in the baseline simulation. Five prevention strategies were simulated based on information obtained from the literature. RESULTS: The model simulates the four stages of the medication delivery system: prescribing, transcribing, dispensing, and administering drugs. We simulated interventions that have been demonstrated in prior studies to decrease error rates. The results suggest that an integrated medication delivery system can save up to 1,226 days of excess hospitalization and $1.4 million in associated costs annually in a large hospital. The results of the analyses regarding the effects of the interventions on the additional hospital costs associated with ADEs are somewhat sensitive to the distribution of errors in the hospital, more sensitive to the costs of an ADE, and most sensitive to the proportion of medication errors resulting in ADEs. CONCLUSIONS: The results suggest that clinical information systems are potentially a cost-effective means of preventing ADEs in hospitals and demonstrate the importance of viewing medication errors from a systems perspective. Prevention efforts that focus on a single stage of the process had limited impact on the overall error rate. This study suggests that system-wide changes to the medication delivery system are required to drastically reduce mediation errors that may result in ADEs in a hospital setting. (+info)