PubMed · 12394069
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David S Lindberg. 2002. Clarifying causality.. https://doi.org/10.1097/00000446-200206000-00003
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BACKGROUND AND OBJECTIVE: The incidence of adverse drug reactions (ADRs) in hospitalized elderly patients is an important clinical problem. The purpose of this study was to determine the incidence of ADRs in elderly in-patients, to analyze the factors involved in their presentation and to evaluate the reactions detected. PATIENTS AND METHOD: Prospective multicenter study in patients older than 65 years during their stay in hospital or nursing home. The assessment consisted of a complete geriatric evaluation and a protocol for collecting information on suspected ADRs during hospitalization or nursing home stay. A multivariate analysis by multiple logistic regression was performed. RESULTS: The study included 865 patients: 185 (21%) from 5 hospital units; 325 (38%) from 8 convalescent centers; and 355 (41%) from 8 long-term centers. The incidence of ADRs was 9%. In acute units the incidence was 15%; in post-acute units, 5%; and in long-term centers, 10% (p < 0.004). In the global multivariate analysis, the risk of experiencing an ADR was associated with a greater use of medications (OR = 1.15; 1.07 1.23 for each additional drug), the presentation of delirium (OR = 3.6; 1.95-6.85) and the type of unit (acute OR = 2.6; 1.16-6.01; long-term OR = 3.3; 1.62-7.05). Fifty type A ADRs were detected (65%). With regard to severity, 36 (47%) were moderate, 27 (35%) were mild, and 14 (18%) were severe. Causality: 58 (76%) probable and 17 (20%) possible. Potential avoidability: 39 (51%) were unavoidable and 38 (49%) were totally or partially avoidable; of these, 15 (39%) were the result of an interaction with another drug. CONCLUSIONS: The incidence of ADRs in our study was close to 10%. ADRs were associated with the frequency of use, presence of delirium and type of unit, and occurred most frequently in acute and long-term units. ADRs were principally type A, moderate severity, probable causality and partially avoidable.
Schemes for spontaneous reporting of adverse drug reactions are important to post-marketing safety surveillance worldwide. In the UK, doctors, dentists, coroners, and pharmacists are allowed to report through the yellow card scheme, but nurses were not until October, 2002. We used a similar programme to assess the role of community and hospital nurses in reporting of adverse drug reactions. The proportion and quality of reports received from nurses was similar to that of those received from doctors: we received reports from one in seven nurses eligible to report, compared with one in eight doctors; 137 of 177 nurse reports and 676 of 984 doctor reports were judged to be appropriate according to regulatory authority criteria (95% CI for difference between proportions 1.4-15.0, z=2.3, p=0.02). Our findings suggest that nurses, who form the largest proportion of health-care staff in the UK, can play a valuable part in improvement of pharmacovigilance.
During January 24-April 13, 2003, smallpox vaccine was administered to 32,644 civilian health-care and public health workers in 54 jurisdictions as part of an effort to prepare the United States for a possible terrorist attack using smallpox virus. This report updates information on all vaccine-associated adverse events among civilians vaccinated since the beginning of the vaccination program and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of April 13.