PMID- 37349651
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231023
IS  - 1573-904X (Electronic)
IS  - 0724-8741 (Print)
IS  - 0724-8741 (Linking)
VI  - 40
IP  - 9
DP  - 2023 Sep
TI  - Preventive Pharmacovigilance: timely and precise prevention of adverse events 
      through person-level patient screening and dose-level product surveillance.
PG  - 2103-2106
LID - 10.1007/s11095-023-03548-3 [doi]
AB  - The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated 
      with drugs and vaccines. Current PV programs are of a reactive nature and rest 
      entirely on data science, i.e., detecting and analyzing AE data from 
      provider/patient reports, health records and even social media. The ensuing 
      preventive actions are too late for people who have experienced AEs and often 
      overly broad, as responses include entire product withdrawals, batch recalls, or 
      contraindications of subpopulations. To prevent AEs in a timely and precise 
      manner, it is necessary to go beyond data science and incorporate measurement 
      science into PV efforts through person-level patient screening and dose-level 
      product surveillance. Measurement-based PV may be called 'preventive 
      pharmacovigilance', the goal of which is to identify susceptible individuals and 
      defective doses to prevent AEs. A comprehensive PV program should contain both 
      reactive and preventive components by integrating data science and measurement 
      science.
CI  - (c) 2023. The Author(s).
FAU - Yu, Yihua Bruce
AU  - Yu YB
AUID- ORCID: 0000-0001-8043-6530
AD  - Bio and Nano-technology Center, University of Maryland School of Pharmacy, 20 
      North Penn Street, Baltimore, MD, 21201, USA. byu@rx.umaryland.edu.
AD  - Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Drive, 
      Rockville, MD, 20850, USA. byu@rx.umaryland.edu.
FAU - Briggs, Katharine T
AU  - Briggs KT
AD  - Bio and Nano-technology Center, University of Maryland School of Pharmacy, 20 
      North Penn Street, Baltimore, MD, 21201, USA.
AD  - Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Drive, 
      Rockville, MD, 20850, USA.
FAU - Taraban, Marc B
AU  - Taraban MB
AD  - Bio and Nano-technology Center, University of Maryland School of Pharmacy, 20 
      North Penn Street, Baltimore, MD, 21201, USA.
AD  - Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Drive, 
      Rockville, MD, 20850, USA.
LA  - eng
GR  - 75F40119C10104/U.S. Food and Drug Administration/
GR  - ARP-25/National Institute for Innovation in Manufacturing Biopharmaceuticals/
PT  - Journal Article
DEP - 20230622
PL  - United States
TA  - Pharm Res
JT  - Pharmaceutical research
JID - 8406521
RN  - 0 (Vaccines)
SB  - IM
EIN - Pharm Res. 2023 Aug 10;:. PMID: 37561324
MH  - Humans
MH  - *Pharmacovigilance
MH  - *Vaccines/adverse effects
PMC - PMC10547648
OTO - NOTNLM
OT  - dose-level product surveillance
OT  - measurement science
OT  - person-level patient screening
OT  - preventive pharmacovigilance
OT  - vaccine safety
EDAT- 2023/06/23 01:10
MHDA- 2023/10/23 00:42
PMCR- 2023/06/22
CRDT- 2023/06/22 23:32
PHST- 2023/05/03 00:00 [received]
PHST- 2023/06/03 00:00 [accepted]
PHST- 2023/10/23 00:42 [medline]
PHST- 2023/06/23 01:10 [pubmed]
PHST- 2023/06/22 23:32 [entrez]
PHST- 2023/06/22 00:00 [pmc-release]
AID - 10.1007/s11095-023-03548-3 [pii]
AID - 3548 [pii]
AID - 10.1007/s11095-023-03548-3 [doi]
PST - ppublish
SO  - Pharm Res. 2023 Sep;40(9):2103-2106. doi: 10.1007/s11095-023-03548-3. Epub 2023 
      Jun 22.