{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T15:30:34Z","timestamp":1790523034042,"version":"4.1.0"},"reference-count":15,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2008,9,2]],"date-time":"2008-09-02T00:00:00Z","timestamp":1220313600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2008,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>A vaccine against pandemic influenza may be rapidly and widely distributed, and could be used in populations with little prior exposure to influenza vaccines. Under such conditions, it will be important to gain timely information about the rates of vaccine adverse events, ideally by using electronic data from large populations. Many public and private health plans and payers have such information.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Between May and September 2007, we conducted a decision maker interview and technical assessment with several health plans in the United States. The interview and survey evaluated technical capability, organizational capacity, and willingness to participate in a coordinated program of rapid safety research targeting pandemic and other influenza vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eleven health plans (eight private, three public) participated in the decision maker interview. Most interviewees were medical directors or held similar positions within their organizations. Participating plans provided coverage and\/or care for approximately 150 million members in the U.S. Nine health plans completed a technical assessment survey. Most decision makers indicated interest and willingness to participate in a coordinated rapid safety surveillance program, and all reported the necessary claims data analysis experience. Respondents noted legal, procedural, budgetary, and technical barriers to participation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Senior decision makers representing private and public health plans were willing and asserted the ability of their organizations to participate in pandemic influenza vaccine safety monitoring. Developing working relationships, negotiating contracts, and obtaining necessary regulatory and legal approvals were identified as key barriers. These findings may be generalizable to other vaccines and pharmaceutical products. Copyright \u00a9 2008 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.1642","type":"journal-article","created":{"date-parts":[[2008,9,2]],"date-time":"2008-09-02T07:37:19Z","timestamp":1220341039000},"page":"1137-1141","source":"Crossref","is-referenced-by-count":14,"title":["Potential population\u2010based electronic data sources for rapid pandemic influenza vaccine adverse event detection: a survey of health plans"],"prefix":"10.1002","volume":"17","author":[{"given":"Kristen M.","family":"Moore","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April","family":"Duddy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Miles","family":"Braun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Platt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Brown","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2008,9,2]]},"reference":[{"key":"e_1_2_1_2_2","unstructured":"FDA approves first U.S. vaccine for humans against the avian influenza virus H5N1. U.S. Food and Drug Administration 2007.www.fda.gov\/bbs\/topics\/news\/2007\/new01611.html[Accessed 6 February 2008]."},{"key":"e_1_2_1_3_2","unstructured":"Committee on the Assessment of the US Drug Safety System.The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington DC: Institute of Medicine of the National Academies 2006."},{"issue":"43","key":"e_1_2_1_4_2","first-page":"1007","article-title":"Withdrawal of rotavirus vaccine recommendation","volume":"48","author":"Centers for Disease Control and Prevention","year":"1999","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"13","key":"e_1_2_1_5_2","doi-asserted-by":"crossref","first-page":"1436","DOI":"10.1093\/ajhp\/52.13.1436","article-title":"Reporting of adverse events to MedWatch","volume":"52","author":"Piazza\u2010Hepp TD","year":"1995","journal-title":"Am J Health Syst Pharm"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.9.824"},{"issue":"10","key":"e_1_2_1_7_2","first-page":"258","article-title":"Update: recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine","volume":"57","author":"Centers for Disease Control and Prevention","year":"2008","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3180616c0a"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.ede.0000155506.05636.a4"},{"key":"e_1_2_1_10_2","unstructured":"Vaccine Safety Datalink (VSD) Project. Centers for Disease Control and Prevention.http:\/\/www.cdc.gov\/vaccinesafety\/vsd\/[Accessed 4 February 2008]."},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-6-235"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.humpath.2007.01.007"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1197\/jamia.M2371"},{"key":"e_1_2_1_14_2","unstructured":"Food and Drug Administration Amendments Act of 2007 Public Law 110\u201385 (HR 3580) 110thCongress 1st session (September 27 2007)."},{"key":"e_1_2_1_15_2","unstructured":"The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety. U.S. Food and Drug Administration 2008. (Accessed athttp:\/\/www.fda.gov\/oc\/initiatives\/advance\/ reports\/report0508.html)."},{"key":"e_1_2_1_16_2","unstructured":"Safety study of GBS following Menactra meningococcal vaccination (NCT00575653). In National Institutes of Health (NIH) Clinical Trials Registry 2007.www.clincialtrials.gov"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.1642","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.1642","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T08:08:48Z","timestamp":1700035728000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.1642"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2008,9,2]]},"references-count":15,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2008,12]]}},"alternative-id":["10.1002\/pds.1642"],"URL":"https:\/\/doi.org\/10.1002\/pds.1642","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2008,9,2]]}}}