| Title |
Postmarketing Safety Surveillance
|
|---|---|
| Published in |
Drug Safety, February 2013
|
| DOI | 10.1007/s40264-013-0018-x |
| Pubmed ID | |
| Authors |
Preciosa M. Coloma, Gianluca Trifirò, Vaishali Patadia, Miriam Sturkenboom |
| Abstract |
The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drug's clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of spontaneous reports of adverse drug reactions. Vast improvements in computing capabilities have provided opportunities to automate signal detection, and several worldwide initiatives are exploring new approaches to facilitate earlier detection, primarily through mining of routinely-collected data from electronic healthcare records (EHR). This paper provides an overview of ongoing initiatives exploring data from EHR for signal detection vis-à-vis established spontaneous reporting systems (SRS). We describe the role SRS has played in regulatory decision making with respect to safety issues, and evaluate the potential added value of EHR-based signal detection systems to the current practice of drug surveillance. Safety signal detection is both an iterative and dynamic process. It is in the best interest of public health to integrate and understand evidence from all possibly relevant information sources on drug safety. Proper evaluation and communication of potential signals identified remains an imperative and should accompany any signal detection activity. |
Mendeley readers
The data shown below were compiled from readership statistics for 131 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Canada | 2 | 2% |
| Indonesia | 1 | <1% |
| Israel | 1 | <1% |
| Korea, Republic of | 1 | <1% |
| Slovenia | 1 | <1% |
| Japan | 1 | <1% |
| Unknown | 124 | 95% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 26 | 20% |
| Student > Ph. D. Student | 21 | 16% |
| Researcher | 19 | 15% |
| Student > Postgraduate | 9 | 7% |
| Student > Bachelor | 8 | 6% |
| Other | 23 | 18% |
| Unknown | 25 | 19% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 36 | 27% |
| Computer Science | 21 | 16% |
| Pharmacology, Toxicology and Pharmaceutical Science | 14 | 11% |
| Agricultural and Biological Sciences | 8 | 6% |
| Nursing and Health Professions | 4 | 3% |
| Other | 20 | 15% |
| Unknown | 28 | 21% |
Attention Score in Context
This research output has an Altmetric Attention Score of 6. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 September 2021.
All research outputs
#4,692,881
of 22,772,779 outputs
Outputs from Drug Safety
#505
of 1,697 outputs
Outputs of similar age
#51,845
of 283,063 outputs
Outputs of similar age from Drug Safety
#5
of 14 outputs
Altmetric has tracked 22,772,779 research outputs across all sources so far. Compared to these this one has done well and is in the 76th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,697 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 10.7. This one has gotten more attention than average, scoring higher than 64% of its peers.
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We're also able to compare this research output to 14 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 57% of its contemporaries.