Recommendations for Use of Temperature Monitors Upon Incorrect. Product ... This presentation described a change in frequency of incorrect product storage.
Heather Kern, MSPAS, PA-C; Eileen Wilson, MSN; Veronica Urdaneta, MD, MPH; Leonidas Drogaris, MD; Ann Marko, BSN; Susan Galea, MSN; Walter Straus, MD, MPH
Turning Up the Heat: Effect of the New Vaccines for Children (VFC) Program Recommendations for Use of Temperature Monitors Upon Incorrect Product Storage Adverse Event Reporting
Merck & Co., Inc., Kenilworth, NJ, USA
Background ••The Centers for Disease Control and Prevention (CDC) coordinates the Vaccines for Children (VFC) program, which provides recommended vaccines at no cost to qualified children in the US ••The VFC is administered on a state/local level1,2 ••In 2009, the CDC issued vaccine storage requirements, which were later replaced (2012) with an interim guidance and toolkit for vaccine storage and handling3 ••The guidance called for use of digital data loggers (DDLs), which are digital thermometer/data devices used to monitor vaccine storage temperatures4 ••Current VFC guidance recommends contacting the vaccine manufacturer and/or state/local health departments after a temperature excursion has occurred4 ••This presentation described a change in frequency of incorrect product storage adverse event reports (IPS-AERs) following issuance of the 2009 CDC guidance
Methods ••Merck & Co., Inc., Kenilworth, NJ, USA, systematically evaluates vaccine safety concerns and investigates if warranted. The safety database was queried (01Jan2004 through 31Dec2016) to identify all IPS-AERs associated with the following products: Brand Name
Generic Name
PNEUMOVAX®23
Pneumococcal Vaccine, Polyvalent (23-Valent) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Varicella Virus Vaccine Live (Oka-Merck) Rotavirus Vaccine, Live, Oral, Pentavalent Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Hepatitis B Vaccine (Recombinant) Hepatitis A Vaccine, Inactivated Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) Human Papillomavirus 9-Valent Vaccine, Recombinant Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
M-M-R®II VARIVAX® RotaTeq® GARDASIL® RECOMBIVAX HB® VAQTA® PedvaxHIB® GARDASIL®9 ProQuad®
••IPS-AERS were compared before and after the 2009 CDC guidance, comparing US IPS-AERs with ex-US reports during the same period ••Spontaneous reporting is a voluntary system of adverse event (AE) reporting used to generate early warning signals. This system has limitations in assessing causality, including under-reporting, biased reporting, and incomplete data in reports. Spontaneous reports in the safety database are based on a passive reporting system, which may not quantify the risk associated with a product because the denominator used is derived from sales data, which may not accurately represent prescribing and usage levels5
Results ••Following the DDL guidance, a progressive increase in IPS-AERs was identified in the US, from 1 report in 2004 to 12,993 reports in 2016 –– More specifically, 3.5% of the US reports occurred from 2004 through 2008, with the remaining 96.5% occurring from 2009 through 2016 after the guidance for DDLs was instituted ••In contrast, ex-US IPS-AERs have not increased at a similar rate: 0 (2004) - 216 reports (2016)
Percentage of Incorrect Product Storage Reports per Region 1Jan2004 to 31Dec2016 Ex-US 4%
US IPS Reports Compared With Ex-US 1Jan2004 to 31Dec2016 12000 10000 8000
Interim guidance and toolkit for vaccine storage and handling 2012
6000
••92% of the IPS reports included the preferred term (PT) “no adverse event”
4000
Percentage of US IPS Reports With “No Adverse Event” Versus Without PT “No Adverse Event”
2000 0
Comparison of Reported Events of IPS As Compared With PT Vaccination Failure and Treatment Failure* vs Reported Adverse Events**
US 96%
US incorrect product storage Ex-US incorrect product storage CDC issued vaccine storage requirements 2009
••A search performed in the post-marketing database for the preferred terms “vaccination failure” and “treatment failure” for the same time period did not show any significant increase in reporting, with 17 events in 2004 and 62 events in 2016
7%
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
US IPS Reports by Product 1Jan2004 to 31Dec2016
Number of reports with “no adverse event'
93%
Number of reports without “no adverse event'
••No serious reports were found in the database in conjunction with IPS ••The information on IPS reports did not change the safety profile of the products queried
Reports of IPS Through Time in the Top 10 Reporting States US IPS Reports by Product 1Jan2004 to 31Dec2016
*Includes MedDRA preferred terms “vaccination failure” and “treatment failure” **Excludes MedDRA preferred term “no adverse event” ***2009 reports of AEs: of the 331 cases of Pain AND IPS in 2009, all were female and nonserious. Age ranged from 1.42 to 18, median 14, average 13.9. Pain is an AE in the company core datasheet.
Conclusions • The VFC program in the US has been instrumental in delivering vaccines to children of all income levels and reducing the numbers of preventable illness nationwide2 • VFC DDL guidance was followed by an increase in IPS-AERs (for queried vaccines) • No similar trend was seen outside the US • Despite the increase in IPS-AERs, few associated adverse events have been reported; no new safety concerns were identified • These findings suggest that the increase in IPS-AERs was associated with the introduction of use of DDLs and suggests the need for further assessment References 1. Santoli JM, Rodewald LE, Maes EF, Battaglia MP, Coronado VG.Vaccines for Children program, United States, 1997. Pediatrics. 1999;104(2):e15. 2. Whitney CG, Zhou F, Singleton J, Schuchat A; Centers for Disease Control and Prevention (CDC). Benefits from immunization during the vaccines for children program era - United States, 1994-2013. MMWR Morb Mortal Wkly Rep. 2014;63(16):352-355. 3. Vaccine Storage and Handling Interim Guidance. CDC: October 2012. 4. Vaccine Storage & Handling Toolkit. June 2016. CDC. http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/ storage-handling-toolkit.pdf. 5. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-396. Disclosure This presentation was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (sponsor). All authors are employees of the company and may or may not hold stock options in the company.
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kernhe_194133-0001-ACVR_Poster_IPS_v2.00_FINAL 03/29/2017 Output Size: 90” x 42” Scale: 200%, DUE 3/29
