PMID- 26219291
OWN - NLM
STAT- MEDLINE
DCOM- 20160711
LR  - 20220317
IS  - 2212-3911 (Electronic)
IS  - 1574-8863 (Linking)
VI  - 10
IP  - 3
DP  - 2015
TI  - The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety 
      Regulatory Actions: a Systematic Review.
PG  - 234-50
AB  - INTRODUCTION: Disproportionality analysis (DA) of adverse drug reactions 
      spontaneous reporting (SR) databases is used to identify signals of 
      disproportionate reporting (SDR). The objective of this study was to identify the 
      generation of SDR in the published literature and whether it led to regulatory 
      action. METHODS: A systematic literature search in MEDLINE and Cochrane Central 
      Register for Controlled Trials (CENTRAL) in a 10-year period, from 2005 to 2014, 
      was conducted, to identify studies designed to detect drug safety signals through 
      the use of disproportionality measures applied to spontaneous reporting databases 
      of adverse drug reactions. RESULTS: Seventy three studies were included. The 
      number of publications has been rising over the study time period. Forty nine 
      studies focus on drug-event combinations. Large international and smaller 
      national or regional databases were identified. The disproportionality measures 
      applied included frequentist and Bayesian methods and some studies used more than 
      one method. SDRs were identified in more than ninety percent of the studies. Ten 
      studies were found to be confirmatory of previous regulatory decision. 
      CONCLUSION: It was not found any safety signal issued by drug regulatory agencies 
      exclusively generated by DA. More research devoted to this issue is needed, since 
      the value of these methods on drug safety signaling and their impact on drug 
      regulation actions remains to be established.
FAU - Dias, Patricia
AU  - Dias P
AD  - Pharmacovigilance Unit of the Centre Region of Portugal, AIBILI - Association for 
      Innovation and Biomedical Research on Light, Azinhaga de Santa Comba, Celas 
      3000-548 Coimbra, Portugal. patriciadinisdias@gmail.com.
FAU - Penedones, Ana
AU  - Penedones A
FAU - Alves, Carlos
AU  - Alves C
FAU - Ribeiro, Carlos F
AU  - Ribeiro CF
FAU - Marques, Francisco B
AU  - Marques FB
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
PL  - United Arab Emirates
TA  - Curr Drug Saf
JT  - Current drug safety
JID - 101270895
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*legislation & jurisprudence
MH  - Bayes Theorem
MH  - Consumer Product Safety/legislation & jurisprudence
MH  - *Data Mining/statistics & numerical data
MH  - *Databases, Factual/statistics & numerical data
MH  - Drug Approval/*legislation & jurisprudence/statistics & numerical data
MH  - Drug and Narcotic Control/*legislation & jurisprudence/statistics & numerical 
      data
MH  - Drug-Related Side Effects and Adverse Reactions/diagnosis/*epidemiology
MH  - Humans
MH  - Patient Safety/legislation & jurisprudence
MH  - *Pharmacovigilance
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
EDAT- 2015/07/30 06:00
MHDA- 2016/07/12 06:00
CRDT- 2015/07/30 06:00
PHST- 2015/07/04 00:00 [received]
PHST- 2015/03/07 00:00 [revised]
PHST- 2015/07/27 00:00 [accepted]
PHST- 2015/07/30 06:00 [entrez]
PHST- 2015/07/30 06:00 [pubmed]
PHST- 2016/07/12 06:00 [medline]
AID - CDS-EPUB-69145 [pii]
AID - 10.2174/1574886310666150729112903 [doi]
PST - ppublish
SO  - Curr Drug Saf. 2015;10(3):234-50. doi: 10.2174/1574886310666150729112903.