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Sever, John L.; Brenner, Alan I.; Gale, Arnold D.; Lyle, Jerry M.; Moulton, Lawrence H.; West, David J.
doi: 10.1002/pds.712pmid: 12051118
Purpose To assess the safety of a licensed anthrax vaccine given to nearly 400 000 US military personnel, reports of adverse events (AEs) submitted to the Vaccine Adverse Event Reporting System (VAERS) were reviewed and evaluated medically. Methods The Anthrax Vaccine Expert Committee (AVEC), a civilian panel of private‐sector physicians and other scientists, reviewed 602 VAERS reports using a Delphic approach (structured expert consensus) to assess the causal relationship between vaccination and the reported AEs and sought to identify unexpected patterns in the occurrence of medically important events. Reports were entered into a database and used to profile AEs with respect to person, type/location, relative frequency, severity/impact, concomitant illness or receipt of other drugs or vaccines, and vaccine lot. Results Nearly half the reports noted a local injection‐site AE, with more than one‐third of these involving a moderate to large degree of inflammation. Six events qualified as serious AEs (SAEs), and all were judged to be certain consequences of vaccination. Three‐quarters of the reports cited a systemic AE (most common: flu‐like symptoms, malaise, rash, arthralgia, headache), but only six individual medically important events were judged possibly or probably due to vaccine (aggravation of spondyloarthropathy (2), anaphylactoid reaction, arthritis (2), bronchiolitis obliterans organizing pneumonia) Conclusions Since some cases of local inflammation involved distal paresthesia, AVEC recommends giving subcutaneous injections of AVA over the inferior deltoid instead of the triceps to avoid compression injury to the ulnar nerve. At this time, ongoing evaluation of VAERS reports does not suggest a high frequency or unusual pattern of serious or other medically important AEs. Copyright © 2002 John Wiley & Sons, Ltd.
van Grootheest, A. C.; van Puijenbroek, E. P.; de Jong–van den Berg, L. T. W.
doi: 10.1002/pds.702pmid: 12051119
Purpose The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. Methods A total of 15 293 reports, sent to the Netherlands Pharmacovigilance Foundation Lareb between 1995 and 2000 were analysed for the characteristics of pharmacists' reports and the differences with reports from physicians i.e. dispersion of adverse drug reactions in relation to the different System and Organ Classes, the seriousness of the reports according to the CIOMS criteria and the documentation grade of the reports. A total of 200 reports were selected at random and their quality assessed. Results Pharmacists are responsible for 40% of the reports sent in to Lareb during this period. Their reports more frequently concern adverse effects in relation to skin and the eyes. Adverse drug reactions reported by pharmacists tend to be less severe than those reported by physicians and pharmacists' reports tend to be of a lower documentation grade than those of physicians. Also, the quality of the clinicial information is higher in physicians' reports. Conclusions The contribution of pharmacists to the voluntary reporting system in the Netherlands is of great importance, both for the number and quality of the reports. Copyright © 2002 John Wiley & Sons, Ltd.
Lewis, James D.; Brensinger, Colleen; Bilker, Warren B.; Strom, Brian L.
doi: 10.1002/pds.698pmid: 12051120
Purpose The objective of this study was to evaluate the validity and completeness of the General Practice Research Database (GPRD) as a tool for research into inflammatory bowel disease epidemiology. Methods Patients diagnosed with inflammatory bowel disease were identified from GPRD. Mailed surveys were sent to the general practitioner caring for a stratified random sample of 170 of these patients and collected information on the diagnosis of inflammatory bowel disease and the most recent surgery and hospitalization. Results Usable surveys were returned for 157 patients (92%). The inflammatory bowel disease diagnosis was highly probable or probable in 144 (92%, 95% CI 86 to 96%). Among the 53 patients with a potentially incident inflammatory bowel disease diagnosis, 33 (62%) had the first recorded diagnosis in GPRD within 30 days of the date reported in the survey (median difference −8 days; interquartile range 0 to −81days). Of 12 surgeries and 25 hospitalizations reported in the survey, 11 (92%) and 19 (76%) were identified in GPRD, respectively. Conclusions The diagnosis of inflammatory bowel disease in GPRD appears reliable for most patients. Important medical events such as hospitalizations and surgery are recorded at a high rate, although algorithms to identify these events are complex. Copyright © 2002 John Wiley & Sons, Ltd.
Ackerman, Deborah L.; Unützer, Jürgen; Greenland, Sander; Gitlin, Michael
doi: 10.1002/pds.694pmid: 12051121
Objective We evaluated inpatient treatment of depression, prescribing patterns for antidepressants, and associated hospital charges. Methods We reviewed administrative data of the UCLA Neuropsychiatric Hospital between July 1994 and July 1997 for all 1698 hospitalizations for mood disorders. We evaluated drug utilization patterns and hospital charges by analysis of variance and multiple regression, and by stratifying on diagnosis, severity, age, and other factors. Results Length of stay was the major contributor to total charges, which included room charges and charges for services, procedures, supplies, and tests. The selective serotonin reuptake inhibitors (SSRIs) were prescribed most often (to 47% of patients), followed by the atypicals (heterocyclics, 12%), the tricyclics (TCAs, 7%), venlafaxine (7%) and the monoamine oxidase inhibitors (MAOIs, < 1%). The atypicals were given to the oldest patients. After controlling for length of stay, patient age, genders and comorbidity, the atypicals were associated with the highest total inpatient charges: $2000 more than MAOIs, $600 more than SSRIs, and $600 more than venlafaxine. Higher charges were the result of more expensive procedures, especially ECT. Discussion The SSRIs were the most commonly used antidepressant. Charges for antidepressant medications contributed only 0.5% of total inpatient charges. Patients receiving atypicals had among the highest total charges, partly because of the higher use of ECT. They may represent a more severely depressed group who have not responded to other antidepressants. Copyright © 2002 John Wiley & Sons, Ltd.
Hammond, Isaac W.; Ferguson, Jeffrey A.; Kwong, Kenneth; Muniz, Edmundo; Delisle, Frank
doi: 10.1002/pds.695pmid: 12051122
Purpose This retrospective study used a pharmaceutical company's global safety database to determine the reporting rate of hyponatremia and/or syndrome of inappropriate secretion of anti‐diuretic hormone (SIADH) among vincristine‐treated patients and to explore the possibility of at‐risk population subgroups. Method We searched the Eli Lilly and Company's computerized adverse event database for all reported cases of hyponatremia and/or SIADH as of 1 November 1999 that had been reported during the use of vincristine. Results A total of 76 cases of hyponatremia and/or SIADH associated with vincristine use were identified. The overall reporting rate was estimated to be 1.3/100 000 treated patients. The average age of patients was 35.6 ± 28.3 years, and 62% were males. Approximately 75% of the patients were receiving treatment for leukemia or lymphoma. Among the 39 reports that included information on race, the racial distribution was: 1 Black, 3 Caucasian, and 35 Asian. Conclusion Our data suggest that Asian patients may be at increased risk of hyponatremia and/or SIADH associated with vincristine use. Although the overall reported rate of SIADH associated with vincristine is very low, physicians caring for Asian oncology patients should be aware of this potential serious but reversible adverse event. Copyright © 2002 John Wiley & Sons, Ltd.
Zaidenstein, R.; Eyal, S.; Efrati, S.; Akivison, L.; Koren Michowitz, M.; Nagornov, V.; Golik, A.
doi: 10.1002/pds.693pmid: 12051123
Purpose To evaluate the incidence of serious adverse drug events (ADEs) caused by cardiovascular drugs during hospitalization in a department of internal medicine, and to identify patients at highest risk. Patients and methods All the patients treated with cardiovascular drugs and/or anticoagulants in the department between November 1999 and January 2000 were recruited into the study. During hospitalization the patients' charts were reviewed by a pharmacist and a clinician, and the occurrence of serious ADEs was assessed using the Naranjo algorithm. ‘Possible’ and ‘doubtful’ ADEs were not counted. Results Of 496 patients who were enrolled in the study, 20 (4%) had serious ADEs. Compared to patients without ADEs, patients in the ADE group were older (72 ± 12.6 years (mean ± SD) vs. 65 ± 13 years, p = 0.048), their average stay in hospital was longer (7.3 ± 5.5 days vs. 5.2 ± 3.7 days, p = 0.018) and their mean urea levels were higher (10.8 ± 9.3 mmol/l vs. 7.8 ± 5.3 mmol/l, p = 0.027). The most frequent background pathologies of the 20 patients with ADEs were hypertension (in 18 (90%)) and atrial fibrillation (in nine (45%)). In 50% of the the ADE group there was a history of drug allergies. The ADEs recorded were bleeding in four (20%), arrhythmias in six (30%), orthostatic hypotension in six (30%) and skin necrosis, paranoid reaction, acute hepatitis and acute renal failure in four (20%). The causative drugs were warfarin (which accounted for 25% of the ADEs), beta‐blockers (15%), propafenone (5%), amiodarone (5%), and Ca2+‐channel blockers, nitrates and diuretics (together accounting for 50% of ADEs). Drug combinations were implicated in 50% of ADE. Conclusions Serious ADEs were developed by 4% of hospitalized patients taking cardiovascular drugs. Those at highest risk were older, were receiving multiple drug therapy and had higher urea levels. Warfarin and beta‐blockers were the drugs causing the largest number of adverse effects . ADEs are an important cause of preventable morbidity, often with serious economic implications and special attention should be given to their prevention. Copyright © 2002 John Wiley & Sons, Ltd.
Bäckström, M.; Hägg, S.; Mjörndal, T.; Dahlqvist, R.
doi: 10.1002/pds.697pmid: 12051124
Objective This study was carried out in order to investigate the utilization pattern of metamizole to better estimate the quantitative risk of agranulocytosis since a cluster of such cases have been observed in Sweden. Methods Cases of agranulocytosis submitted to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) between 1996 and 1999 were identified. Based on the utilization pattern of metamizole in inpatients at three hospitals and in outpatients in two counties in northern Sweden risk estimates of agranulocytosis during metamizole treatment were estimated. The utilization of metamizole was investigated by scanning 3567 case records at 10 hospital departments as well as stored prescriptions at six pharmacies during a 3‐month study period. Results Ten cases of agranulocytosis during treatment with metamizole have been reported to SADRAC over the period 1996 to 1999. During the 3‐month study period metamizole was prescribed to 666 (19%) inpatients. Of these, approximately 96% received the drug for less than 1 week, 7.2% had used the drug previously. At the participating pharmacies 112 metamizole prescriptions for outpatients were found. The drug was prescribed in 34% for less than 1 week, in 28% for 7–15 days, and in 38% for more than 15 days. The mean prescribed daily dose was 2.7 g. Given certain assumptions including the actual amounts prescribed the calculated risks of agranulocytosis would be approximately one out of every 31 000 metamizole‐treated inpatients and one of every 1400 metamizole‐treated outpatients. Conclusion This study indicates that in most inpatients the use of metamizole in northern Sweden was within the approved indications for the drug. However, a considerable number of outpatients received the drug for a longer time than recommended and this may carry an increased risk for developing agranulocytosis. Copyright © 2002 John Wiley & Sons, Ltd.
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