Digital drug safety surveillance: monitoring pharmaceutical products in twitter.
BACKGROUND
Traditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines.


OBJECTIVE
The aim of the study was to evaluate the level of concordance between Twitter posts mentioning AE-like reactions and spontaneous reports received by a regulatory agency.


METHODS
We collected public English-language Twitter posts mentioning 23 medical products from 1 November 2012 through 31 May 2013. Data were filtered using a semi-automated process to identify posts with resemblance to AEs (Proto-AEs). A dictionary was developed to translate Internet vernacular to a standardized regulatory ontology for analysis (MedDRA(®)). Aggregated frequency of identified product-event pairs was then compared with data from the public FDA Adverse Event Reporting System (FAERS) by System Organ Class (SOC).


RESULTS
Of the 6.9 million Twitter posts collected, 4,401 Proto-AEs were identified out of 60,000 examined. Automated, dictionary-based symptom classification had 86 % recall and 72 % precision [corrected]. Similar overall distribution profiles were observed, with Spearman rank correlation rho of 0.75 (p < 0.0001) between Proto-AEs reported in Twitter and FAERS by SOC.


CONCLUSIONS
Patients reporting AEs on Twitter showed a range of sophistication when describing their experience. Despite the public availability of these data, their appropriate role in pharmacovigilance has not been established. Additional work is needed to improve data acquisition and automation.
Department of Biomedical Engineering, Boston University, Boston, USA.
Clark C
CC
Freifeld
John S
JS
Brownstein
Christopher M
CM
Menone
Wenjie
W
Bao
Ross
R
Filice
Taha
T
Kass-Hout
Nabarun
N
Dasgupta
D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D020407:Internet; D004366:Nonprescription Drugs / Q000009:adverse effects*; D060735:Pharmacovigilance; D055553:Prescription Drugs / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
D004366:Nonprescription Drugs; D055553:Prescription Drugs