PMID- 31684774
OWN - NLM
STAT- MEDLINE
DCOM- 20200629
LR  - 20200629
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 53
IP  - 6
DP  - 2019 Nov
TI  - Industry Assessment of the Contribution of Patient Support Programs, Market 
      Research Programs, and Social Media to Patient Safety.
PG  - 736-745
LID - 10.1177/2168479019877384 [doi]
AB  - BACKGROUND: Over the past decade, the volume of adverse events (AEs) reported to 
      marketing authorization holders and regulators has been rapidly increasing each 
      year, which has led to significant challenges in patient safety assessment. Three 
      data sources that have largely contributed to the expansion in adverse event 
      reports are patient support programs (PSPs), market research programs (MRPs), and 
      social media. In this study, we sought to further understand the contribution of 
      these safety data sources to the characterization of a product's safety profile. 
      METHODS: Three separate approaches were taken that, when combined, can be used to 
      evaluate each data source. The first identified any core company data sheet 
      changes or drug safety label changes. The second evaluated the similarity of 
      information through proportions of AEs between each solicited data source and 
      spontaneous sources. Lastly, the completeness of information reported was 
      evaluated through vigiGrade and compared across each data source. RESULTS: One 
      drug safety label change was identified from a patient support program, which 
      involved regular contact with health care providers. No label changes were 
      identified from market research programs or social media. Patient support 
      programs, market research programs, and social media report similar proportions 
      for HLGT as spontaneous sources. Market research programs and social media 
      display very low vigiGrade scores. When broken down by subtype, traditional PSPs 
      display high vigiGrade scores, while patient assistance programs display lower 
      vigiGrade scores that were program dependent. CONCLUSIONS: This study did not 
      demonstrate that certain data sources such as market research programs, social 
      media, and patient assistance programs meaningfully contributed to the further 
      understanding of the characterization of a product's safety profile.
FAU - Jokinen, Jeremy
AU  - Jokinen J
AUID- ORCID: 0000-0001-8484-5788
AD  - AbbVie Inc, North Chicago, IL, USA.
FAU - Bertin, Dominique
AU  - Bertin D
AD  - Amgen Inc, Thousand Oaks, CA, USA.
FAU - Donzanti, Bruce
AU  - Donzanti B
AD  - Genentech Inc, South San Francisco, CA, USA.
FAU - Hormbrey, Janet
AU  - Hormbrey J
AD  - Merck & Co, Kenilworth, NJ, USA.
FAU - Simmons, Valerie
AU  - Simmons V
AD  - Eli Lilly and Company, Windlesham, United Kingdom.
FAU - Li, Hal
AU  - Li H
AD  - Merck & Co, Kenilworth, NJ, USA.
FAU - Dharmani, Charles
AU  - Dharmani C
AD  - Astellas Pharma, Northbrook, IL, USA.
FAU - Kracht, Karolyn
AU  - Kracht K
AD  - AbbVie Inc, North Chicago, IL, USA.
FAU - Hilzinger, Thomas S
AU  - Hilzinger TS
AUID- ORCID: 0000-0002-2650-5635
AD  - PricewaterhouseCoopers, Chicago, IL, USA.
FAU - Verdru, Peter
AU  - Verdru P
AD  - UCB, Brussels, Belgium.
LA  - eng
PT  - Journal Article
DEP - 20191104
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Drug Labeling
MH  - Health Knowledge, Attitudes, Practice
MH  - Humans
MH  - Marketing/*methods
MH  - Patient Education as Topic/*methods
MH  - Patient Safety/*standards
MH  - Pharmacovigilance
MH  - Product Surveillance, Postmarketing
MH  - Social Media
OTO - NOTNLM
OT  - adverse events
OT  - market research programs
OT  - patient support programs
OT  - pharmacovigilance
OT  - social media
OT  - solicited reports
EDAT- 2019/11/07 06:00
MHDA- 2020/07/01 06:00
CRDT- 2019/11/06 06:00
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/07/01 06:00 [medline]
PHST- 2019/11/06 06:00 [entrez]
AID - 10.1177/2168479019877384 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2019 Nov;53(6):736-745. doi: 10.1177/2168479019877384. Epub 
      2019 Nov 4.