Dataset Information

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

ABSTRACT: The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existing legal requirements and regulatory guidance on social media use in pharmacovigilance was performed based on a survey conducted in 2014-2015. Furthermore, input from two large stakeholder workshops and evidence gathered from the research performed by WEB-RADR on the analysis of social media data were taken into consideration. Whilst analytical results of WEB-RADR indicated limited value of social media in detecting or confirming signals for a majority of the drugs studied, it is important to establish a regulatory framework for the use of social media in pharmacovigilance. Thus, the screening and reporting of suspected adverse reactions remains an important pillar in monitoring the safety and efficacy of medicines and the identification of new safety issues. Principles as to how social media can be used in pharmacovigilance are absolutely needed to provide clarity to patients, healthcare professionals, medicines regulators and the pharmaceutical industry.

SUBMITTER: Brosch S

PROVIDER: S-EPMC6647461 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

Brosch Sabine S de Ferran Anne-Marie AM Newbould Victoria V Farkas Diane D Lengsavath Marina M Tregunno Phil P

Drug safety 20190801 8

The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and t ...[more]

PMID: 30929141

Similar Datasets

Project description:BackgroundA scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products.MethodsOur specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted.ResultsAfter screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others.ConclusionsOur results suggest that the use of social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied.Trial registrationOpen Science Framework ( https://osf.io/kv9hu/ ).

Project description:BackgroundSubstance use, including the non-medical use of prescription medications, is a global health problem resulting in hundreds of thousands of overdose deaths and other health problems. Social media has emerged as a potent source of information for studying substance use-related behaviours and their consequences. Mining large-scale social media data on the topic requires the development of natural language processing (NLP) and machine learning frameworks customized for this problem. Our objective in this research is to develop a framework for conducting a content analysis of Twitter chatter about the non-medical use of a set of prescription medications.MethodsWe collected Twitter data for four medications-fentanyl and morphine (opioids), alprazolam (benzodiazepine), and Adderall® (stimulant), and identified posts that indicated non-medical use using an automatic machine learning classifier. In our NLP framework, we applied supervised named entity recognition (NER) to identify other substances mentioned, symptoms, and adverse events. We applied unsupervised topic modelling to identify latent topics associated with the chatter for each medication.ResultsThe quantitative analysis demonstrated the performance of the proposed NER approach in identifying substance-related entities from data with a high degree of accuracy compared to the baseline methods. The performance evaluation of the topic modelling was also notable. The qualitative analysis revealed knowledge about the use, non-medical use, and side effects of these medications in individuals and communities.ConclusionsNLP-based analyses of Twitter chatter associated with prescription medications belonging to different categories provide multi-faceted insights about their use and consequences. Our developed framework can be applied to chatter about other substances. Further research can validate the predictive value of this information on the prevention, assessment, and management of these disorders.

Project description:BackgroundSocial media has recently provided a remarkable means of delivering health information broadly and in a cost-effective way. Despite its benefits, some difficulties are encountered in attempting to influence the public to change their behavior in response to social media health messages.ObjectiveThis study aimed to explore the factors that affect individuals' acceptance of using social media as a tool for receiving health awareness messages and adapting such content accordingly by developing a smart health awareness message framework.MethodsA quantitative method was adapted to validate the hypotheses and proposed framework through the development of a survey based on the technology acceptance model with the extension of other constructs. The survey was distributed on the web to 701 participants from different countries via Qualtrics software; it generated 391 completed questionnaires, and the response rate was 55.8% (391/701).ResultsOf the 391 respondents, 121 (30.9%) used social media platforms often during the week, and 27 participants (6.9%) did not use social media. In addition, 24.0% (94/391) of the respondents used these platforms to seek health information. On the basis of the results, perceived usefulness (β=.37; P<.001), gain-framed message (β=.04; P<.001), and loss-framed message (β=.08; P<.001) were seen to positively and significantly influence people's intention to use social media as a means to spread information about health promotion. The proposed smart health awareness message framework identifies 64.2% of the variance in intention to use, 55.4% of the variance of perceived usefulness, and 26.2% of the variance of perceived ease of use.ConclusionsThis study sheds light on the factors that are associated with people's intention to use and adopt social media in the health promotion domain. The findings reveal that the intention of using social media for health awareness purposes is positively impacted by the perception of usefulness of social media and the design of health messages. Future research might seek to explore other factors that relate to people's behavior. This point of view will assist health organizations in developing their health messages more effectively and to be patient friendly.

Project description:BackgroundA recent trend among health care professionals is the use of social media for professional purposes. These rapidly expanding media allow for timely and efficient access to health information, but they also carry the potential for increased liability. There is a paucity of research detailing how health care professionals, specifically pharmacists, use social media.ObjectiveTo characterize the use of social media by pharmacists in the Canadian province of Alberta and to identify independent determinants of and perceived barriers to using social media for professional purposes.MethodsData for this mixed-methods study were collected by an online survey in March and April 2014. Alberta pharmacists were invited to participate via e-mail distributed by 2 professional organizations.ResultsThe survey had 273 respondents. Of these, 226 (82.8%) stated that they had a social media account for either personal or professional purposes, and 138 (61.1%) of these reported using social media for professional purposes, although most respondents used social media predominantly for personal reasons. The most commonly reported social media applications were Facebook and Twitter, accessed primarily via smartphones. Of the 273 respondents, 206 (75.5%) had a Facebook account, and 101 (49.0%) of these used Facebook to some extent for professional purposes. Twitter users (104 [38.1%] of respondents) had a higher rate of professional utilization (57/104 [54.8%]). The most commonly identified barrier to using social media for professional purposes was concern over liability. Positive predictors of use of social media for professional purposes included younger age and fewer years of professional experience. Participants perceived the most beneficial aspect of social media (in professional terms) as connecting with pharmacist colleagues.ConclusionMore than 80% of pharmacists in Alberta reported that they had a social media account, and over half of them reported using their accounts for professional purposes. Although Facebook had a higher reported rate of utilization in general, a greater proportion of respondents reported using Twitter for professional purposes. Individuals and organizations seeking to expand their professional social media presence should focus on Twitter.

Project description:Purpose Resident physicians use social media (SM) for many reasons. We sought to characterize current SM use by radiation oncology (RO) trainees for education and professional development. Methods and Materials An anonymous 40-question survey was sent by e-mail to RO residents in the 2018 to 2019 academic year. SM platform use, time spent on SM, professional use, and opinions regarding SM use were assessed. Descriptive statistics and a univariate logistic regression analysis were performed to identify factors associated with perceptions of SM and spending >25% of SM time for academic or professional purposes. Results Of the 615 residents surveyed, 149 responded (24% response rate). Facebook (73%), theMednet (62%), Instagram (59%), Twitter (57%), and Doximity (50%) were the top SM platforms used. Most respondents (53%) reported <25% of overall SM time on professional/academic purposes, and 21% reported using SM >60 minutes per day over the past week. Residents with an RO mentor on SM (n = 35; 24%; odds ratio [OR]: 2.79; 95% confidence interval [CI], 1.29-6.08; P = .010), those participating in RO discussions on SM (n = 71; 48%; OR: 2.85; 95% CI, 1.42-5.72; P = .003), and those interacting with professional societies (n = 69; 46%; OR: 7.11; 95% CI, 3.32-15.24; P < .001) were more likely to spend >25% of their SM time on professional/academic purposes. The vast majority of respondents agreed that SM exposed them to novel educational content (82%) and was helpful for career development (65%). In addition, 69% agreed that SM can improve clinical skills and knowledge. A substantial minority agreed that SM distracts them from studying (38%) or they felt pressure to have a SM presence (29%). Conclusions Most RO residents reported that SM provides novel educational content and can help with career development. Potential disadvantages of SM for trainees may include distraction and pressure to maintain a SM presence. SM use by RO trainees merits further research to optimize its potential for education and professional development.

Dataset Information

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

Publications

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets