Tags

Type your tag names separated by a space and hit enter

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.
Pharmacoepidemiol Drug Saf. 2012 Jan; 21 Suppl 1:291-7.PD

Abstract

In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise.

Authors+Show Affiliations

Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA. michael.nguyen@fda.hhs.govNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22262619

Citation

Nguyen, Michael, et al. "The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise." Pharmacoepidemiology and Drug Safety, vol. 21 Suppl 1, 2012, pp. 291-7.
Nguyen M, Ball R, Midthun K, et al. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:291-7.
Nguyen, M., Ball, R., Midthun, K., & Lieu, T. A. (2012). The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiology and Drug Safety, 21 Suppl 1, 291-7. https://doi.org/10.1002/pds.2323
Nguyen M, et al. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:291-7. PubMed PMID: 22262619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. AU - Nguyen,Michael, AU - Ball,Robert, AU - Midthun,Karen, AU - Lieu,Tracy A, PY - 2012/1/21/entrez PY - 2012/1/25/pubmed PY - 2012/5/10/medline SP - 291 EP - 7 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 21 Suppl 1 N2 - In 2009, the Department of Health and Human Services created the new Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine. PRISM has now been integrated into the FDA's Mini-Sentinel pilot program. It strengthens the federal vaccine safety enterprise in two important ways. First, PRISM monitors the largest US general population cohort designated for active surveillance of vaccine safety. Second, PRISM links data from health plans with data from state and city immunization registries, which were a crucial source of exposure data in the H1N1 vaccine evaluation. The Mini-Sentinel data that support PRISM are updated quarterly, and PRISM can conduct medical record review for validation of computerized data. The FDA has structured PRISM as a program that includes specific vaccine evaluations, development of an operational framework to guide the design of vaccine safety evaluations, and development of new statistical methods. A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size. The PRISM program creates important opportunities by offering a robust, responsive new surveillance program with features complementary to existing systems. Methodological and logistical lessons can be shared among PRISM and other surveillance systems, offering potential synergies. FDA and PRISM will work to maximize the program's unique strengths and contributions to a unified federal vaccine safety enterprise. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/22262619/The_Food_and_Drug_Administration's_Post_Licensure_Rapid_Immunization_Safety_Monitoring_program:_strengthening_the_federal_vaccine_safety_enterprise_ L2 - https://doi.org/10.1002/pds.2323 DB - PRIME DP - Unbound Medicine ER -