scholarly journals The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study

2006 ◽  
Vol 15 (9) ◽  
pp. 675-682 ◽  
Author(s):  
Willemijn M. Meijer ◽  
Martina C. Cornel ◽  
Helen Dolk ◽  
Hermien E. K. de Walle ◽  
Nicola C. Armstrong ◽  
...  
Keyword(s):  
Congenital Anomaly ◽  
Drug Safety ◽  
Descriptive Study ◽  
European Network ◽  
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.

scholarly journals Operation Save the World from Adverse Drug Reactions: findings from a drug safety surveillance programme in Nigeria

2019 ◽  
Vol 7 ◽  
pp. S46 ◽  
Author(s):  
Yohanna Kambai Avong ◽  
Bolajoko Jatau ◽  
Gbenga Ayodele Kayode ◽  
Blessing Ukpabi ◽  
Eunice Bosede Avong ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Drug Reactions ◽  
Surveillance Programme ◽  
Safety Surveillance ◽  
Drug Safety Surveillance ◽  
The World

A Primer of Drug Safety Surveillance: An Industry Perspective

1992 ◽  
Vol 8 (4) ◽  
pp. 162-167
Author(s):  
Marjorie C. Allan
Keyword(s):  
Adverse Event ◽  
Drug Safety ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Event Data ◽  
The Public ◽  
Safety Surveillance ◽  
Pharmaceutical Manufacturers ◽  
Drug Safety Surveillance ◽  
Clinical Drug

Objective: To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. Data Sources: This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. Study Selection: The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. Data Synthesis: The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Conclusions: Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

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