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On-label and off-label use of high-dose influenza vaccine in the United States, 2010-2012

tetano

Editor, Senior Moderator
Hum Vaccin Immunother. 2015 Mar 9:0. [Epub ahead of print]
[h=1]On-label and off-label use of high-dose influenza vaccine in the United States, 2010-2012.[/h] McGrath LJ[SUP]1[/SUP], Brookhart MA.
[h=3]Author information[/h]

[h=3]Abstract[/h] Background: High-dose inactivated, influenza vaccine was licensed by the FDA in December 2009 for adults aged 65 years and older. The ACIP did not issue or state a preference for a specific vaccine in the elderly population. The extent of its on-label and off-label use is unknown. Methods: Using the MarketScan Commercial Claims and Encounters and the Medicare Supplemental database, we identified individuals who received the high-dose influenza vaccine or the standard, seasonal trivalent influenza vaccine between January 1, 2010 and December 31, 2012. For people aged ≥65 years, we used multivariable regression to assess the association between patient and provider level variables and high-dose influenza vaccine versus standard influenza vaccine. We characterized all off-label high-dose vaccine administered to people younger than 65 years of age, and investigated whether sicker patients were targeted for off-label use by examining the association between various comorbid conditions and receipt of the high-dose vaccine among adults aged 18-64. Results: Among patients aged ≥65 years who received an influenza vaccine, 18.4% received the high-dose vaccine. Uptake was minimal in 2010, but 25% and 32% of influenza shots were the high-dose formulation in 2011 and 2012, respectively. Almost 27,000 seniors received a second high-dose vaccine with a median of 368 days (IQR: 350-387 days) between doses. Older age, family practice physicians, and having PPO insurance were positively associated with receiving high-dose vaccine. There were 36,624 off-label high-dose vaccines administered. Half of the patients receiving off-label doses were aged 50-64. Adults aged 18-64 years receiving high-dose vaccine were more likely to have chronic comorbidities than people receiving standard influenza vaccine; however, there was not one specific illness that seemed to be targeted by physicians. Conclusions: In the first three years since licensure, use of the high-dose vaccine among seniors has been limited. The safety of this vaccine should be monitored closely among two groups of people - seniors receiving repeat doses and people <65.


[h=4]KEYWORDS:[/h] ACIP, Advisory Committee on Immunization Practices; Adult vaccination; CPT, Current Procedural Terminology; HMO, Health Maintenance Organization; High-dose influenza vaccine; ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; IQR, Interquartile range; Influenza prevention; Influenza vaccine; PPO, Preferred provider organization

PMID: 25751700 [PubMed - as supplied by publisher]
 
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