The Value and Limitations of Patient Registers in Drug Surveillance

1979 ◽  
pp. 197-202
Author(s):  
Barbro Westerholm
Keyword(s):  
Drug Surveillance

A Clinical Pharmacy-Oriented Drug Surveillance Network: Results of a Nationwide Antibiotic Utilization Review of Bacterial Pneumonia–1987

DICP ◽  
1989 ◽  
Vol 23 (2) ◽  
pp. 162-170
Author(s):  
Thaddeus H. Grasela ◽  
Jerome J. Schentag ◽  
Steven J. Boekenoogen ◽  
Kenneth D. Crist ◽  
William L. Lowes ◽  
...  
Keyword(s):  
Bacterial Pneumonia ◽  
Prescribing Patterns ◽  
Oral Drug ◽  
Utilization Review ◽  
Antibiotic Prescribing ◽  
Drug Surveillance ◽  
Surveillance Network ◽  
Gram Negative ◽  
Days Of Therapy ◽  
Culture Positive

One hundred eighteen pharmacists enrolled in the Drug Surveillance Network completed a survey of antibiotic prescribing patterns for bacterial infections. A total of 319 hospitalized patients being treated for suspected or documented bacterial pneumonia were monitored, and this paper summarizes the data collected on this specific subpopulation. Two hundred three patients (64 percent) were treated for community-acquired pneumonia and 116 patients (36 percent) were treated for nosocomial pneumonia. Seventy-three percent of the nosocomial pneumonias were culture-positive, with a gram-negative microorganism as the predominant isolate. Forty-eight percent of the community-acquired pneumonias were culture-positive with a mixture of gram-positive and gram-negative organisms. Fifty percent of patients were treated with a single agent, 33 percent with two antibiotics, and the remaining 17 percent with a combination of three or more antibiotics. A satisfactory response was noted for 62 and 76 percent of the patients with nosocomial and community-acquired pneumonias, respectively. Twenty percent of the pneumonia patients were switched to oral drug after an average of five days of therapy and discharged from the hospital. Twenty-five adverse events that were possibly or probably related to the antibiotic regimen were reported in 23 of the 350 patients for an overall incidence of 6.5 percent. The results of this survey provide a cross-sectional view of antibiotic prescribing patterns for the treatment of bacterial pneumonia and the outcome of therapy under actual clinical conditions of use.

scholarly journals Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
A. Anil Sinaci ◽  
Gokce B. Laleci Erturkmen ◽  
Suat Gonul ◽  
Mustafa Yuksel ◽  
Paolo Invernizzi ◽  
...  
Keyword(s):  
Clinical Research ◽  
Real Life ◽  
Critical Factor ◽  
Drug Surveillance ◽  
Safety Study ◽  
Data Interoperability ◽  
Common Data Elements ◽  
Lombardy Region ◽  
Research Activities ◽  
Data Elements

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.

Doing the right things and doing things right: inpatient drug surveillance assisted by clinical decision support

2015 ◽  
Vol 22 (4) ◽  
pp. 236-242 ◽  
Author(s):  
Pieter J Helmons ◽  
Bas O Suijkerbuijk ◽  
Prashant V Nannan Panday ◽  
Jos G W Kosterink
Keyword(s):  
Decision Support ◽  
Clinical Decision Support ◽  
Clinical Decision ◽  
Drug Surveillance ◽  
The Right

Adverse Drug Reactions in Children Leading to Hospital Admission

PEDIATRICS ◽  
1988 ◽  
Vol 82 (1) ◽  
pp. 24-29
Author(s):  
Allen A. Mitchell ◽  
Peter G. Lacouture ◽  
Jane E. Sheehan ◽  
Ralph E. Kauffman ◽  
Samuel Shapiro
Keyword(s):  
Adverse Drug Reactions ◽  
Neonatal Intensive Care ◽  
Hospital Admissions ◽  
Teaching Hospitals ◽  
Surveillance Program ◽  
Pediatric Hospital ◽  
Drug Reactions ◽  
Drug Surveillance ◽  
Community Hospitals ◽  
Tetanus Vaccine

To provide information regarding pediatric hospital admissions prompted by adverse drug reactions, data were reviewed from an intensive drug surveillance program in which 10,297 patients admitted to diverse pediatric wards at four teaching and three community hospitals were systematically monitored. Among 3,026 neonatal intensive care unit admissions, 0.2% were prompted by adverse drug reactions; among 725 children with cancer, 22% of admissions were prompted by adverse drug reactions. Among 6,546 children with other conditions monitored on general medical and specialty wards at two teaching hospitals and on general pediatric wards at three community hospitals, 2% (131) of admissions were prompted by adverse drug reactions. Two patients (0.03%) died because of their reactions. The proportion of admissions prompted by drug reactions increased between infancy and 5 years of age and tended to be relatively stable thereafter. The drugs most commonly implicated in the admissions were phenobarbital, aspirin, phenytoin, ampicillin/amoxicillin, theophylline/aminophylline, trimethoprim-sulfamethoxazole, and diphtheria-pertussis-tetanus vaccine. Similar proportions of admissions were prompted by adverse drug reactions in teaching hospitals (2.1%) and in community hospitals (1.8%), and the drug groups implicated in these admissions were generally similar in the two settings. In contrast to adult populations, children with adverse drug reactions account for a small proportion of hospital admissions. Findings from this large, systematic study of pediatric admissions to teaching and community hospitals may serve as a baseline to which other pediatric facilities can compare their experience.

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