PMID- 29725886
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 5
IP  - 2
DP  - 2018 Jun
TI  - Spontaneous Reporting on Adverse Events by Consumers in the United States: An 
      Analysis of the Food and Drug Administration Adverse Event Reporting System 
      Database.
PG  - 117-128
LID - 10.1007/s40801-018-0134-0 [doi]
AB  - BACKGROUND: Voluntary reports on adverse events (AEs) submitted by consumers have 
      been facilitated through the MedWatch program in the United States (US), but few 
      studies have described the characteristics of voluntary reports. OBJECTIVE: The 
      aim of this study was to reveal the characteristics of current voluntary reports 
      on AEs reported by consumers and healthcare professionals. METHODS: We performed 
      analysis on voluntary reports of AEs in the US Food and Drug Administration AE 
      Reporting System (FAERS) database submitted in 2016. We compared reports by 
      consumers with those by healthcare professionals. RESULTS: The number of 
      voluntary reports by consumers has increased since 2013 in the US. Reports by 
      consumers were different from ones by health professionals in several important 
      aspects such as demographics and outcomes of patients, AEs, and suspect drugs. 
      The proportion of reports on female patients and on disability as a patient 
      outcome were higher in reports by consumers than in those by healthcare 
      professionals. Consumers more frequently reported concomitant drugs compared with 
      healthcare professionals. Time to report varied among the occupations and 
      depending on seriousness of outcomes. CONCLUSIONS: Our analysis of voluntary AE 
      reports in the US FAERS database has shown that voluntary reports tended to 
      include AEs related to subjective symptoms, as in some previous studies on 
      patient reporting in the EU. Voluntary reports by consumers seemed to be 
      different from ones by healthcare professionals in important aspects including 
      demographics and reporting behaviors. These findings suggest that the 
      heterogeneities should be addressed appropriately in using spontaneous reports.
FAU - Toki, Tadashi
AU  - Toki T
AD  - Laboratory of Pharmaceutical Regulation and Sciences, Graduate School of 
      Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 
      113-0033, Japan.
FAU - Ono, Shunsuke
AU  - Ono S
AUID- ORCID: 0000-0001-7941-0464
AD  - Laboratory of Pharmaceutical Regulation and Sciences, Graduate School of 
      Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 
      113-0033, Japan. shun-ono@mol.f.u-tokyo.ac.jp.
LA  - eng
GR  - KAKENHI: 26460215/The Ministry of Education, Culture, Sports, Science, and 
      Technology, Japan/
PT  - Journal Article
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC5984610
COIS- FUNDING: This study was funded by a Japanese government-based Grant-in-aid from 
      the Ministry of Education, Culture, Sports, Science, and Technology, Tokyo, Japan 
      (Grant KAKENHI: 26460215). The funders had no role in study design, data 
      collection and analysis, decision to publish, or preparation of the manuscript. 
      CONFLICT OF INTEREST: Tadashi Toki was employed by Daiichi Sankyo Co. Ltd during 
      the study period. Shunsuke Ono declares no conflict of interest. ETHICS APPROVAL: 
      This study was performed on anonymized patient data and ethics committee approval 
      was therefore not required.
EDAT- 2018/05/05 06:00
MHDA- 2018/05/05 06:01
PMCR- 2018/05/03
CRDT- 2018/05/05 06:00
PHST- 2018/05/05 06:00 [pubmed]
PHST- 2018/05/05 06:01 [medline]
PHST- 2018/05/05 06:00 [entrez]
PHST- 2018/05/03 00:00 [pmc-release]
AID - 10.1007/s40801-018-0134-0 [pii]
AID - 134 [pii]
AID - 10.1007/s40801-018-0134-0 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2018 Jun;5(2):117-128. doi: 10.1007/s40801-018-0134-0.