Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States

Chen, R. T.; Glasser, John W.; Rhodes, Philip; Davis, Robert L.; Barlow, William E.; Thompson, Robert S.; Mullooly, John P.; Black, Steven; Shinefield, Henry R.; Vadheim, Constance M.; Marcy, S. Michael; Ward, Joel I.; Wise, Robert P.; Wassilak, Steven G.F.; Hadler, Stephen C.; Team, the Vaccine Safety Datalink

doi:10.1542/peds.99.6.765

Cited by 294 publications

(149 citation statements)

References 30 publications

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“…Therefore, enhanced post-marketing vaccine effectiveness, coverage, and safety surveillance is a critical component of any immunization program. [2][3][4] In Ontario, Canada's largest province (population 13.5 million with 142,448 births in 2013), 5 infant and toddler immunizations are almost exclusively administered through physician offices and funded under the Ontario Health Insurance Plan (OHIP). 6 Measles, mumps, rubella (MMR) and meningococcal conjugate serogroup C (MenC) vaccines are recommended at 12 months of age, while diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type B (DTaP-IPV-Hib) combination vaccine and pneumococcal conjugate vaccine (PC) are given at 2, 4, 6, and 18 months, and at 2, 4, and 12 months, respectively.…”

Section: Introductionmentioning

confidence: 99%

Validation of infant immunization billing codes in administrative data

Schwartz

Wing

et al. 2015

Human Vaccines & Immunotherapeutics

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Ontario has a single payer provincial health insurance program. Administrative data may provide a potentially robust source of information for post-marketing vaccine studies. Vaccine-specific immunization billing codes were introduced in 2011. Our objective was to validate Ontario's universal health care administrative datasets to assess infant immunization status. Electronic medical record data from the Electronic Medical Record Administrative data Linked Database (EMRALD) was used as the reference standard to calculate performance characteristics of the Ontario Health Insurance Plan (OHIP) database vaccine-specific and general immunization codes for 4 primary infant immunizations: diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type B (DTaP-IPV-Hib) combination vaccine, pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine, and meningococcal conjugate serogroup C vaccine. OHIP billing claims had specificity ranging from 81% to 92%, sensitivity 70% to 83%, positive predictive value (PPV) 97% to 99%, and negative predictive value (NPV) 13% to 46% for identifying the various specific vaccines in administrative data. For cohorts vaccinated in the new code introduction phase, using both the vaccinespecific and general codes had higher sensitivity than the vaccine-specific codes alone. In conclusion, immunization billing claims from administrative data in Ontario had high specificity and PPV, moderate sensitivity, and low NPV. This study identifies some of the applications of utilizing administrative data for post-marketing vaccine studies. However, limitations of these data decrease their utility for measuring vaccine coverage and effectiveness. Therefore, the establishment of a comprehensive and linkable immunization registry should be a provincial priority.

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Section: Introductionmentioning

confidence: 99%

Validation of infant immunization billing codes in administrative data

Schwartz

Wing

et al. 2015

Human Vaccines & Immunotherapeutics

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“…The study population included members of seven managed care organizations (MCOs) participating in the VSD project, a collaborative project between the CDC and eight MCOs established in 1991 to monitor and evaluate vaccine safety [2,3]. This project collects data on more than 8.8 million members annually including information on demographics, health plan enrollment, vaccinations, and medical encounters.…”

Section: Methodsmentioning

confidence: 99%

Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study

Jackson

Belongia

et al. 2009

BMC Infect Dis

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BackgroundLocal reactions are the most commonly reported adverse events following tetanus and diphtheria toxoid (Td) vaccine and the risk of local reactions may increase with number of prior Td vaccinations.MethodsTo estimate the risk of medically attended local reactions following Td vaccination in adolescents and young adults we conducted a six-year retrospective cohort study assessing 436,828 Td vaccinations given to persons 9 through 25 years of age in the Vaccine Safety Datalink population from 1999 through 2004.ResultsOverall, the estimated risk of a medically attended local reaction was 3.6 events per 10,000 Td vaccinations. The lowest risk (2.8 events per 10,000 vaccinations) was found in the 11 to 15 year old age group. In comparison with that group, the event risks were significantly higher in both the 9 to 10 and 21 to 25 year old age groups. The risk of a local reaction was significantly higher in persons who had received another tetanus and diphtheria toxoid containing vaccine (TDCV) in the previous five years (incidence rate ratio, 2.9; 95% confidence interval, 1.2 to 7.2). Twenty-eight percent of persons with a local reaction to Td vaccine were prescribed antibiotics.ConclusionMedically attended local reactions were uncommon following Td vaccination. The risk of those reactions varied by age and by prior receipt of TDCVs. These findings provide a point of reference for future evaluations of the safety profile of newer vaccines containing tetanus or diphtheria toxoid.

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“…In particular, we suggest that the distributed data model-a secure means of collecting data from various sites that has been used successfully for quality measurement, vaccine surveillance, and other purposes-would be a desirable method of secure data collection. 12,14 Additionally, although the government and private sector have already made major investments in health information technology in the last few years, more dialogue and collaboration is necessary to build an information technology infrastructure ideally suited for measurement and reporting.…”

Section: Government As a Funder Of Scientific Researchmentioning

confidence: 99%

Posing A Framework To Guide Government’s Role In Payment And Delivery System Reform

Sood

Higgins

2012

Health Affairs

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Innovative payment reform initiatives occur in both the public and private sector, but the optimal role in such reforms of the public sector, specifically the Centers for Medicare and Medicaid Services, is up for debate. In this article we examine recent experiences with publicprivate collaboration on payment and delivery reform and present a framework for determining the role of the government in spurring reform. We argue that as a purchaser, the government should consider the scale and maturity of private-sector activity in determining how to approach designing and implementing payment and delivery system reform. The government can further spur innovation by implementing payment reform for providers less ready to participate in it-such as smaller provider groups with limited organizational and technological capacity to implement reform-through identifying best practices related to attribution models and quality benchmarks and promoting dialogue with the private sector about the testing of new reform programs.

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Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States

Cited by 294 publications

References 30 publications

Validation of infant immunization billing codes in administrative data

Validation of infant immunization billing codes in administrative data

Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study

Posing A Framework To Guide Government’s Role In Payment And Delivery System Reform

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