The Use of Social Media in Detecting Drug Safety–Related New Black Box Warnings, Labeling Changes, or Withdrawals: Scoping Review
Bibliographic record
Abstract
BACKGROUND: Social media has become a new source for obtaining real-world data on adverse drug reactions. Many studies have investigated the use of social media to detect early signals of adverse drug reactions. However, the trustworthiness of signals derived from social media is questionable. To confirm this, a confirmatory study with a positive control (eg, new black box warnings, labeling changes, or withdrawals) is required. OBJECTIVE: This study aimed to evaluate the use of social media in detecting new black box warnings, labeling changes, or withdrawals in advance. METHODS: This scoping review adhered to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. A researcher searched PubMed and EMBASE in January 2021. Original studies analyzing black box warnings, labeling changes, or withdrawals from social media were selected, and the results of the studies were summarized. RESULTS: A total of 14 studies were included in this scoping review. Most studies (8/14, 57.1%%) collected data from a single source, and 10 (71.4%) used specialized health care social networks and forums. The analytical methods used in these studies varied considerably. Three studies (21.4%) manually annotated posts, while 5 (35.7%) adopted machine learning algorithms. Nine studies (64.2%) concluded that social media could detect signals 3 months to 9 years before action from regulatory authorities. Most of these studies (8/9, 88.9%) were conducted on specialized health care social networks and forums. On the contrary, 5 (35.7%) studies yielded modest or negative results. Of these, 2 (40%) used generic social networking sites, 2 (40%) used specialized health care networks and forums, and 1 (20%) used both generic social networking sites and specialized health care social networks and forums. The most recently published study recommends not using social media for pharmacovigilance. Several challenges remain in using social media for pharmacovigilance regarding coverage, data quality, and analytic processing. CONCLUSIONS: Social media, along with conventional pharmacovigilance measures, can be used to detect signals associated with new black box warnings, labeling changes, or withdrawals. Several challenges remain; however, social media will be useful for signal detection of frequently mentioned drugs in specialized health care social networks and forums. Further studies are required to advance natural language processing and mine real-world data on social media.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".