PMID- 29429809
OWN - NLM
STAT- MEDLINE
DCOM- 20180918
LR  - 20220410
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 36
IP  - 11
DP  - 2018 Mar 7
TI  - Turning up the heat: Effect of new vaccine for children's (VFC) program 
      recommendations for use of temperature monitors upon incorrect product storage 
      adverse event reporting.
PG  - 1516-1520
LID - S0264-410X(17)31467-6 [pii]
LID - 10.1016/j.vaccine.2017.10.059 [doi]
AB  - BACKGROUND: The Centers for Disease Control and Prevention (CDC) coordinates the 
      Vaccines For Children (VFC) program, which provides free vaccines to qualified 
      children in the US. In 2009, the CDC issued Vaccine Storage Requirements, which 
      were later replaced (2012) with an interim guidance and toolkit for vaccine 
      storage and handling. The guidance called for use of Digital Data Loggers (DDL) 
      to monitor vaccine storage temperatures. We describe a change in frequency of 
      Incorrect Product Storage Reports (IPSRs) following issuance of the 2009 CDC 
      guidance. METHODS: Merck & Co., Inc., Kenilworth, NJ, USA, systematically 
      evaluates vaccine safety concerns for all products. The safety database was 
      queried (01-Jan-2004 through 31-December-2016) to identify all IPSRs associated 
      with 10 vaccines. We compared IPSRs received prior to and following the 2009 CDC 
      guidance, comparing reports received from the US with those received from 
      international sources during the same period. RESULTS: Following the release of 
      the DDL guidance, a progressive increase in IPSRs was identified in the US (1 
      report received in 2004, 12,993 reports in 2016). In contrast, non-US IPSRs - 
      have not had a similar increase: no reports received in 2004, 216 reports 
      received in 2016. US reports of IPSRs 2004 through 2016 account for 96% of 
      reports worldwide. There were no serious reports found in the database in 
      conjunction with IPSRs, nor were there any additional safety findings in any of 
      the reports with additional events reported. CONCLUSION: VFC DDL guidance was 
      followed by an increase in IPSRs. No similar trend was seen outside the US (where 
      no broad change in DDL guidance occurred). Despite the increase in IPSRs, there 
      have been few associated adverse events (AEs) reported; no new safety concerns 
      were identified. These findings suggest that the increase in IPSRs was associated 
      with the introduction of use of DDLs, and suggests the need for further impact 
      assessment.
CI  - Copyright (c) 2017 Elsevier Ltd. All rights reserved.
FAU - Wilson, Eileen
AU  - Wilson E
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Zhu, Cong
AU  - Zhu C
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Galea, Susan
AU  - Galea S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Marko, Ann
AU  - Marko A
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Victoria Urdaneta, Veronica
AU  - Victoria Urdaneta V
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Straus, Walter
AU  - Straus W
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: 
      walter_straus@merck.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Vaccines)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Databases, Factual
MH  - *Drug Storage
MH  - Humans
MH  - *Immunization Programs
MH  - *Temperature
MH  - United States
MH  - *Vaccination/adverse effects/methods/standards
MH  - *Vaccines
OTO - NOTNLM
OT  - Digital Data Logger
OT  - Pediatric
OT  - Pharmacovigilance
OT  - Product storage
OT  - Vaccine
EDAT- 2018/02/13 06:00
MHDA- 2018/09/19 06:00
CRDT- 2018/02/13 06:00
PHST- 2017/08/29 00:00 [received]
PHST- 2017/10/18 00:00 [revised]
PHST- 2017/10/19 00:00 [accepted]
PHST- 2018/02/13 06:00 [pubmed]
PHST- 2018/09/19 06:00 [medline]
PHST- 2018/02/13 06:00 [entrez]
AID - S0264-410X(17)31467-6 [pii]
AID - 10.1016/j.vaccine.2017.10.059 [doi]
PST - ppublish
SO  - Vaccine. 2018 Mar 7;36(11):1516-1520. doi: 10.1016/j.vaccine.2017.10.059.