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Issue 971: January 3, 2012



FDA expands use of the pneumococcal conjugate vaccine Prevnar 13 for people age 50 and older
On December 30, 2011, FDA issued a press release announcing that it has approved the use of the pneumococcal 13-valent conjugate vaccine, Prevnar 13 [Wyeth Pharmaceuticals], to prevent pneumonia and invasive disease caused by the bacterium Streptococcus pneumoniae in people age 50 and older. Prevnar 13 was originally approved on February 24, 2010, for use in infants and children age 6 weeks through 5 years.

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FDA issues Drug Safety Communication regarding liquid acetaminophen marketed for infants
On December 22, 2011, FDA posted an FDA Drug Safety Communication titled Addition of another concentration of liquid acetaminophen marketed for infants. The FDA communication begins as follows:

The U.S. Food and Drug Administration (FDA) is informing the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Until now, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg/0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

To avoid confusion and the potential for dosing errors, consumers, parents, and caregivers should carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use. Do not depend on banners stating it is a new product to identify different concentrations of liquid acetaminophen. Many products have similar banners.

It is also important to use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Patients and caregivers should contact their healthcare professional if they find the measuring device confusing or are unsure how to measure a dose for a child using the device provided.

Healthcare professionals should make sure to provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

FDA has prepared a list of questions and answers and has issued a Consumer Update to provide an additional overview of these changes to OTC liquid acetaminophen marketed for infants.

IAC Express editor's note: The FDA Drug Safety Communication referenced above contains more information, including Additional Information for Consumers and Parents/Caregivers, Additional Information for Healthcare Professionals, and links to documents that will be useful to healthcare professionals who recommend the use of acetaminophen in children.

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Spotlight on redesign of IAC Express web section
IAC Express, IAC's email immunization news and information service, has a new format. The IAC Express web section on has also been redesigned to reflect the e-newsletter's updated design. The IAC Express web section features the current issue of the e-newsletter, as well as the entire archive of previous issues, which date back to 1997. In addition, you will find information about the editorial staff and about subscribing to all of IAC’s free publications.

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GAO report examines Medicare beneficiaries' access to vaccinations covered under Medicare Part D
In December 2011, the U.S. Government Accountability Office (GAO) released a report titled Medicare: Many Factors, Including Administrative Challenges, Affect Access to Part D Vaccinations. A web page that presents highlights of the report states that GAO studied Medicare beneficiaries' access to routinely recommended vaccinations covered under Medicare's Part D prescription drug benefit. These include shingles and Td/Tdap vaccinations.

GAO found that many of the almost 22 million Medicare beneficiaries age 65 and older who were enrolled in Medicare Part D in 2009 did not receive the routinely recommended vaccinations covered by Part D. GAO recommends that the Centers for Medicare & Medicaid Services explore options and take appropriate steps to address administrative challenges, such as physicians’ difficulty verifying beneficiary coverage and billing for Part D-covered vaccinations. The Department of Health and Human Services concurred with GAO’s recommendation.

A PDF version of the Highlights is also available.

Note: GAO is an independent, nonpartisan agency that works for Congress. Often called the "congressional watchdog," GAO investigates how the federal government spends taxpayer dollars.

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IAC updates Td/Tdap standing orders for children 7 years and older and "Vaccine Handling Tips"
IAC recently revised the following two handouts for healthcare professionals.
  1. Standing Orders for Administering Td/Tdap to Children Ages 7 Years and Older; a listing of all of IAC's standing orders for administering vaccines is available.
  2. Vaccine Handling Tips, a useful resource on vaccine storage
IAC's Handouts for Patients and Staff web section offers healthcare professionals and the public more than 250 FREE English-language handouts (many also available in translation), which we encourage website users to print out, copy, and distribute widely.

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IAC posts new translations of the meningococcal vaccines VIS in Portuguese and Haitian Creole 
IAC recently posted the VIS for meningococcal vaccines in Portuguese and Haitian Creole (spoken in Bahamas, Belize, Guyana, Haiti, Mauritius, Seychelles). IAC thanks the Massachusetts Department of Public Health for the translations.
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California develops two resources on preparing vaccines for administration
The California Department of Public Health (CDPH), Immunization Branch, recently developed two staff-education resources on vaccine administration--(1) Preparing Reconstituted Vaccines and (2) Preparing Liquid Vaccines. Each contains detailed, step-by-step instructions and is illustrated with useful color photos.

CDPH offers an extensive collection of Vaccine Administration Job Aids on its EZ-IZ website.

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Influenza vaccination is recommended for almost everyone, so please keep vaccinating
Influenza vaccination is recommended for everyone age 6 months and older, so please keep vaccinating your patients.

Following is a list of resources related to influenza disease and vaccination for healthcare professionals and the public.
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ACIP meeting scheduled for February 22-23 in Atlanta; registration deadline is February 6
The Advisory Committee on Immunization Practices (ACIP) will hold its next meeting on February 22-23 at CDC's Clifton Road campus in Atlanta. The ACIP web section provides detailed information (agenda, lodging, driving directions) about the February meeting.

The online registration deadline for U.S. citizens and non-U.S. citizens is February 6. To attend the ACIP meeting onsite, ACIP attendees (participants and visitors) must register online.

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About IZ Express

IZ Express is supported in part by Grant No. 1NH23IP922654 from CDC’s National Center for Immunization and Respiratory Diseases. Its contents are solely the responsibility of and do not necessarily represent the official views of CDC.

IZ Express Disclaimer
ISSN 2771-8085

Editorial Information

  • Editor-in-Chief
    Kelly L. Moore, MD, MPH
  • Managing Editor
    John D. Grabenstein, RPh, PhD
  • Associate Editor
    Sharon G. Humiston, MD, MPH
  • Writer/Publication Coordinator
    Taryn Chapman, MS
    Courtnay Londo, MA
  • Style and Copy Editor
    Marian Deegan, JD
  • Web Edition Managers
    Arkady Shakhnovich
    Jermaine Royes
  • Contributing Writer
    Laurel H. Wood, MPA
  • Technical Reviewer
    Kayla Ohlde

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