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Pharmacovigilance and Biomedical Informatics: A Model for Future Development
- Source :
- Clinical Therapeutics. 38:2514-2525
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
Abstract
- Purpose The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology. The purpose of this review is to bring a novel lens to pharmacovigilance, looking at the evolution and development of the field of pharmacovigilance from the perspective of biomedical informatics, with the explicit goal of providing a foundation for discussion of the future direction of pharmacovigilance as a discipline. Methods For this review, we searched [publication trend for the log10 value of the numbers of publications identified in PubMed] using the key words [informatics (INF), pharmacovigilance (PV), phar-macovigilance þ informatics (PV þ INF)], for [study types] articles published between [1994-2015]. We manually searched the reference lists of identified articles for additional information. Implications Biomedical informatics has made significant contributions to the infrastructural development of pharmacovigilance. However, there has not otherwise been a systematic assessment of the role of biomedical informatics in enhancing the field of pharmacovigilance, and there has been little cross-discipline scholarship. Rapidly developing innovations in biomedical informatics pose a challenge to pharmacovigilance in finding ways to include new sources of safety information, including social media, massively linked databases, and mobile and wearable wellness applications and sensors. With biomedical informatics as a lens, it is evident that certain aspects of pharmacovigilance are evolving more slowly. However, the high levels of mutual interest in both fields and intense global and economic external pressures offer opportunities for a future of closer collaboration.
- Subjects :
- Pharmacology
Biomedical Research
business.industry
02 engineering and technology
Health informatics
Pharmacovigilance
03 medical and health sciences
Scholarship
020210 optoelectronics & photonics
0302 clinical medicine
Health Administration Informatics
Informatics
0202 electrical engineering, electronic engineering, information engineering
Humans
Medicine
Pharmacology (medical)
Engineering ethics
Social media
Translational research informatics
030212 general & internal medicine
business
Medical Informatics
Computer technology
Subjects
Details
- ISSN :
- 01492918
- Volume :
- 38
- Database :
- OpenAIRE
- Journal :
- Clinical Therapeutics
- Accession number :
- edsair.doi.dedup.....fd803433ab4fbfeafa083c7541308fe2