FDA Launches Drug Safety Surveillance System

2008 ◽  
Vol 38 (12) ◽  
pp. 3
Author(s):  
MARY ELLEN SCHNEIDER
Keyword(s):  
Drug Safety ◽  
Surveillance System ◽  
Safety Surveillance ◽  
Drug Safety Surveillance

Managing Data Quality for a Drug Safety Surveillance System

Drug Safety ◽  
2013 ◽  
Vol 36 (S1) ◽  
pp. 49-58 ◽  
Author(s):  
Abraham G. Hartzema ◽  
Christian G. Reich ◽  
Patrick B. Ryan ◽  
Paul E. Stang ◽  
David Madigan ◽  
...  
Keyword(s):  
Data Quality ◽  
Drug Safety ◽  
Surveillance System ◽  
Safety Surveillance ◽  
Drug Safety Surveillance

Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China

Drug Safety ◽  
2017 ◽  
Vol 41 (1) ◽  
pp. 125-137 ◽  
Author(s):  
Yu Yang ◽  
Xiaofeng Zhou ◽  
Shuangqing Gao ◽  
Hongbo Lin ◽  
Yanming Xie ◽  
...  
Keyword(s):  
Drug Safety ◽  
Safety Surveillance ◽  
Electronic Healthcare Databases ◽  
Drug Safety Surveillance ◽  
Post Marketing

scholarly journals A drug safety surveillance study of a ciprofloxacin / dexamethasone ophthalmic fixed combination in Peruvian population

2020 ◽  
Author(s):  
Homero Contreras-Salinas ◽  
Leopoldo Martín Baiza-Durán ◽  
Mariana Barajas-Hernández ◽  
Alan Omar Vázquez-Álvarez ◽  
Lourdes Yolotzin Rodríguez-Herrera
Keyword(s):  
Drug Safety ◽  
Concomitant Medication ◽  
Fixed Combination ◽  
Real Life ◽  
Prescribing Patterns ◽  
Surveillance Study ◽  
Phone Calls ◽  
Safety Surveillance ◽  
Drug Safety Surveillance ◽  
Post Marketing

(1) Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.

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