Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 491            November 15, 2004

CONTENTS OF THIS ISSUE

  1. New: CDC issues a patient-screening questionnaire to determine who is eligible for nasal-spray influenza vaccine
  2. New: CDC and states to distribute 10.3 million doses of influenza vaccine nationwide
  3. Medicare plans to raise physician payment for administering eligible adult vaccinations from $8 to $18 in 2005
  4. New: MedImmune announces changes in the storage requirements for FluMist influenza vaccine
  5. CDC issues report on vaccination coverage among U.S. children entering school in 2003-04
  6. New VIS translations: VIS for LAIV now available in seven additional languages
  7. Update: CDC continues to update its website with information regarding the influenza vaccine shortage
  8. New: IAC adds a section of Spanish-language resources to its website for the public
  9. DHHS announces contract to secure future egg supply for influenza vaccine production
  10. Reminder: December 1 is the date for CDLHN's free satellite broadcast on vaccine storage and handling

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ABBREVIATIONS: AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NIP, National Immunization Program; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
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November 15, 2004
NEW: CDC ISSUES A PATIENT-SCREENING QUESTIONNAIRE TO DETERMINE WHO IS ELIGIBLE FOR NASAL-SPRAY INFLUENZA VACCINE

On November 12, CDC issued a patient self-screening questionnaire, "Patient Screening Form for Clinics Providing FluMist (Nasal Spray) During the 2004-05 Flu Season." According to an accompanying document, "the FluMist patient screening form is intended to enable self-screening by patients visiting healthcare providers to receive an influenza vaccination. It should be especially useful in influenza clinics. The form is based on the most current ACIP recommendations for this influenza season and will help providers to more easily screen potential vaccinees. In influenza clinics, the form may help reduce long lines by enabling the early identification of those who should NOT be vaccinated during this influenza season. These persons could take themselves out of line or seek clarification or answers from clinic staff before leaving the clinic area."

To access a ready-to-print (PDF) version, go to:
http://www.cdc.gov/flu/professionals/flugallery/pdf/flumistscreeningform.pdf
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November 15, 2004
NEW: CDC AND STATES TO DISTRIBUTE 10.3 MILLION DOSES OF INFLUENZA VACCINE NATIONWIDE

On November 9, CDC issued a press release outlining a plan it and the states have developed to distribute 10.3 million doses of influenza vaccine nationwide. The press release also announces the start of an information hotline for the public and health professionals. Focusing on the topic of influenza and influenza vaccine, the hotline will be staffed 24 hours a day, 7 days a week. Portions of the press release are reprinted below.

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November 9, 2004
For immediate release

CDC AND STATES ANNOUNCE PLAN TO DISTRIBUTE 10.3 MILLION FLU SHOTS NATIONWIDE; PUBLIC HEALTH OFFICIALS CALL ALLOCATION FAIR AND AIMED AT MOST VULNERABLE AMERICANS

Working closely with public health officials nationwide, the Centers for Disease Control and Prevention (CDC) today announced plans to distribute the remaining 10.3 million doses of Aventis Pasteur influenza vaccine to state health departments, which will then help ensure the doses reach those people at highest risk for complications from influenza. The vaccine will be distributed over several weeks through December and into January.

"The work by our colleagues in state and local health departments across the country that has gone into developing this plan has been absolutely extraordinary," said CDC Director Dr. Julie Gerberding. "We're doing everything possible to ensure that vaccine is distributed in a fair way and that it goes to those who need it most."

Under the plan outlined today, states and territories will be receiving 100 percent of any orders they had originally placed under federal, state, and multi-state contracts. Overall, this accounts for 3.1 million doses of vaccine. The distribution plan for the [remaining] 7.2 million doses takes into account three things: (1) the number of high-priority individuals in the state, (2) the number of doses the state has already received, and (3) the state's unmet needs. In the coming weeks, another 1.2 million doses of pediatric [vaccine] will be allocated to states using the same approach.

"The allocation plan announced today, designed to get vaccine to those individuals in greatest need of protection, demonstrates once again the critical role the federal, state, and local governmental public health system, working with the nation's healthcare providers, can play in protecting the public," said Richard A. Raymond, MD, president of the Association of State and Territorial Health Officials (ASTHO) and chief medical officer, Nebraska Health and Human Services System. "While all of the nation's vaccine needs will not be met, this system is fair and will assure that remaining doses of vaccine get to those most in need."

"We support the influenza vaccine allocation method outlined today. It is the best available solution for getting the remaining vaccine to the persons who need it most," said Patrick M. Libbey, executive director, National Association of County and City Health Officials (NACCHO). "The nation's local public health departments will continue to assist their communities and their state health departments in every way possible to protect the public's health during this period of flu vaccine shortage."

Vaccine manufacturer Aventis Pasteur had already shipped 33 million of its expected total 58 million vaccine doses prior to Chiron Corporation's Oct. 5 announcement. The remaining 25 million doses have been allocated at a rate of about 3 million doses per week--or about 14 million doses--since Oct. 11, under a joint distribution plan developed by CDC and Aventis. The vaccine has gone to state public health departments, the Department of Veterans Affairs, long-term care facilities/acute care hospitals, Vaccines for Children program providers, private physicians who care for young children, HMOs, and private providers serving high-priority groups. The plan announced Tuesday will allocate the remaining 7.2 million influenza vaccine doses. . . .

To provide more information to healthcare professionals and the public about influenza and influenza vaccine, CDC has launched (800) CDC-INFO, a new 24/7 central telephone hotline available in English and Spanish. This number will enable people to obtain information from CDC. The number for the hearing impaired is (800) 243-7889 (TTY/TDD).

"We are excited to be able to provide a new information hotline that will help people, including healthcare providers, to get answers about the influenza vaccine and at a later time, a wide range of health and disease-related questions," said Dr. Gerberding. "We encourage people to call this number for information about the flu and this year's flu season or to report when they cannot find vaccine in their communities."

Any information CDC receives about problems in finding influenza vaccine will be shared with state health officials to help them direct the available vaccine to people and places where it's needed most.

Callers to the hotline can choose to hear voice messages on a variety of flu-related topics. Every caller has the option to transfer to a live person who can provide more information.

Healthcare providers can also call the number to report cases of influenza or flu-like illness in their community.

For more information about the flu, visit the CDC website: http://www.cdc.gov/flu or call (800) 232-4636 [(800) CDC-INFO].

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To access the complete press release, go to:
http://www.cdc.gov/od/oc/media/pressrel/r041109.htm

To access a related tele-briefing transcript, go to:
http://www.cdc.gov/od/oc/media/transcripts/t041109.htm
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November 15, 2004
MEDICARE PLANS TO RAISE PHYSICIAN PAYMENT FOR ADMINISTERING ELIGIBLE ADULT VACCINATIONS FROM $8 TO $18 IN 2005

On November 3, the Centers for Medicare & Medicaid Services (CMS) issued a press release announcing new preventive benefits and physician payment increases in Medicare's final rule for physician payment for 2005. The final rule proposes significant increases in payments for administering vaccinations and other injections. Portions of the press release are reprinted below.

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November 3, 2004
For immediate release

MEDICARE ANNOUNCES NEW PREVENTIVE BENEFITS AND PHYSICIAN PAYMENT INCREASES IN FINAL PHYSICIAN PAYMENT RULE FOR 2005

The Centers for Medicare & Medicaid Services (CMS) today issued Medicare's final rule for physician payment for 2005, with new benefits and higher payments for preventive services including a "Welcome to Medicare Physical" and increased payment rates to physicians. The expanded benefits and increased payments result from the Medicare Modernization Act of 2003 (MMA) and are included in the 2005 Physician Fee Schedule rule, which will become effective January 1. . . .

The final rule also dramatically increases payments for vaccinations and other types of injections, reflecting Medicare's rapid action on recommendations from the American Medical Association's Drug Administration Workgroup to assure appropriate payment for all drug administration services. For example, payments for administering the influenza vaccine will rise from $8 to $18. Physicians can also be paid for injections and vaccinations, even when performed on the same day as other Medicare-covered services. Medicare currently does not allow payment for injections provided on the same day as other Medicare services. . . .

The final rule adopts 18 new codes to be used for billing for administering drugs, developed by the American Medical Association's (AMA) CPT Editorial Board. Because new permanent codes will not be included in the CPT until 2006, CMS has developed these temporary codes to allow physicians to be paid for these services beginning January 1, 2005. The rule also accepts the relative values (which are used to determine payment rates) for these codes that were recommended by the AMA's Relative Value Update Committee (RUC). . . .

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To access the complete press release, go to:
http://www.cms.hhs.gov/media/press/release.asp?Counter=1248
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November 15, 2004
NEW: MEDIMMUNE ANNOUNCES CHANGES IN THE STORAGE REQUIREMENTS FOR FLUMIST INFLUENZA VACCINE

Recently, MedImmune, Inc. announced changes in the storage requirements for FluMist live attenuated influenza vaccine (LAIV). The storage changes have FDA approval. The announcement, addressed to healthcare professionals, is reprinted below in its entirety.

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IMPORTANT STORAGE INFORMATION FOR FLUMIST

Dear Healthcare Professional:

In an effort to enable wider and prompt distribution of FluMist, influenza virus vaccine live, intranasal, and to expand the number of vaccine providers, MedImmune, Inc. has taken steps to make it easier for physicians and pharmacists to store the product. Based on new data showing that FluMist remains stable for at least 4 months in conventional frost-free freezers without the use of a freezer insert (known as the FluMist FreezeBox), the FDA has approved a supplement to our license for a modification of the storage requirements FOR DOSES OF FLUMIST SHIPPED BETWEEN NOVEMBER 2, 2004 AND FEBRUARY 8, 2005. These changes in storage requirements are not applicable to FluMist doses currently stored in the FluMist FreezeBox.

Effective immediately, FluMist received after November 2, 2004, may be stored in its packaging without the use of a FluMist FreezeBox until February 8, 2005. Of note:

  • FluMist doses shipped after November 2, 2004, can be stored in a conventional frost-free refrigerator/freezer combination unit (i.e., a refrigerator with a separate, isolated freezer section) without a FluMist FreezeBox. In such units, the temperature setting for the freezer compartment should ideally be set at a low (colder) level, while the temperature setting for the refrigerator compartment should ideally be set at the midpoint. Refrigerator/freezer units with a single control should use the normal setting.
     
  • FluMist CANNOT be stored in dormitory-style refrigerator/freezer units (i.e., a refrigerator not having a separate isolated freezer section).
     
  • Physicians and pharmacists who wish to continue using the FluMist FreezeBox or a manual defrost freezer may certainly do so; in which case the imprinted expiration date on the sprayer remains in effect.
     
  • All unused doses of FluMist shipped between November 2, 2004, and February 8, 2005, and stored in a frost-free freezer without a FluMist FreezeBox must be either returned or discarded effective February 8, 2005, regardless of the expiration date imprinted on the sprayer.
     
  • In mid-January 2005, MedImmune will send a reminder letter on this policy to all healthcare professionals receiving FluMist doses after November 2, 2004.

Please note that this change in the storage requirements for FluMist applies only to doses of THIS SEASON'S VACCINE SHIPPED BETWEEN NOVEMBER 2, 2004 AND FEBRUARY 8, 2005. MedImmune will provide additional data to the FDA in order to determine storage requirements for FluMist for the 2005-2006 influenza season. If you already have a FluMist FreezeBox, a representative will be in contact at the end of the influenza season to provide direction on how to store or return your FluMist FreezeBox. Please do not discard your FluMist FreezeBox until notified.

Should you have any questions regarding this information or would like to order FluMist, please contact us at (877) 358-6478 [(877) FLUMIST] or visit www.flumist.com

Sincerely,

Peter Patriarca, MD
Vice President, Regulatory Affairs
MedImmune, Inc.

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To access the information directly from the FluMist website, go to: http://www.flumist.com/professional/ordering/new.asp
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November 15, 2004
CDC ISSUES REPORT ON VACCINATION COVERAGE AMONG U.S. CHILDREN ENTERING SCHOOL IN 2003-04

CDC published "Vaccination Coverage Among Children Entering School--United States, 2003-04 School Year" in the November 12 issue of MMWR. Portions of the article and Editorial Note are reprinted below.

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[From the article]
One of the national health objectives for 2010 is to sustain >=95% vaccination coverage among children in kindergarten through first grade (objective 14-23). To determine the percentage of vaccination coverage among children entering kindergarten, data on vaccination coverage were analyzed from reports submitted to the National Immunization Program by states, the District of Columbia (DC), and eight current or former U.S. territories for the 2003-04 school year. This report summarizes the results of that analysis, which determined that coverage for all vaccines except hepatitis B (HepB) and varicella was reported at >90% in 45 areas. However, the vaccines required in each reporting area and the methods for surveying kindergarten-aged children vary substantially; in seven states, <20% of eligible children were surveyed. The wide variations in survey populations underscore the need for CDC to continue working with immunization programs in states, DC, and current or former territories to improve survey methods and automate reporting of data. . . .

[From the Editorial Note]
State laws requiring proof of vaccination before entering school have been referred to as a "safety net" for the U.S. vaccination program because they ensure that no child is missed. This safety net relies on the efforts of school nurses, teachers, and others to identify children who are not UTD [up to date]. Findings of uniformly high nationwide coverage during the 2002-03 and 2003-04 school years underscore the success of school entry requirements in boosting vaccine coverage. Childhood vaccination coverage is also measured nationally among children aged 19-35 months. Higher percentages of children are UTD at kindergarten entry than at younger ages, suggesting that school entry laws are a key to ensuring high coverage. . . .

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To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5344a4.htm

To access a ready-to-copy (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5344.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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November 15, 2004
NEW VIS TRANSLATIONS: VIS FOR LAIV NOW AVAILABLE IN SEVEN ADDITIONAL LANGUAGES

Dated 5/24/04, the current version of the VIS for live attenuated intranasal influenza vaccine (LAIV) is now available on the IAC website in seven additional languages: Cambodian, Chinese, Hmong, Japanese, Korean, Tagalog, and Vietnamese. IAC gratefully acknowledges the California Department of Health Services for the translations.

To obtain a ready-to-copy (PDF) version of the VIS for LAIV in CAMBODIAN, go to: http://www.immunize.org/vis/caLAIV04.pdf

To obtain it in CHINESE, go to:
http://www.immunize.org/vis/chLAIV04.pdf

To obtain it in HMONG, go to:
http://www.immunize.org/vis/hmLAIV04.pdf

To obtain it in JAPANESE, go to:
http://www.immunize.org/vis/jpLAIV04.pdf

To obtain it in KOREAN, go to:
http://www.immunize.org/vis/koLAIV04.pdf

To obtain it in TAGALOG, go to:
http://www.immunize.org/vis/taLAIV04.pdf

To obtain it in VIETNAMESE, go to:
http://www.immunize.org/vis/vnLAIV04.pdf

To obtain it in ENGLISH, go to:
http://www.immunize.org/vis/liveflu.pdf

For information about the use of VISs, and for VISs in a total of 32 languages, visit IAC's VIS web section at http://www.immunize.org/vis
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November 15, 2004
UPDATE: CDC CONTINUES TO UPDATE ITS WEBSITE WITH INFORMATION REGARDING THE INFLUENZA VACCINE SHORTAGE

CDC recently updated its website with several documents related to the influenza vaccine shortage. Following are links to the new information.

  1. One item of particular importance is a change made to the Q&A web page "Questions & Answers: Flu Vaccination in the 2004-05 Season." The answer to the question "Can healthcare workers get LAIV?" previously contained incorrect information: It had said that healthy, nonpregnant healthcare workers who are less than 49 years of age can receive LAIV. The information has been corrected to say that healthy, nonpregnant healthcare workers who are less than 50 years of age can receive LAIV.
     
    To access the corrected information, go to:
    http://www.cdc.gov/flu/about/qa/0405vaccination.htm
     
  2. The two-page document "Fact Sheet--Key Facts About the Flu: How to Prevent the Flu and What to Do If You Get Sick" gives patients a succinct overview of the disease, antiviral medications, preventive health habits, and warning signs of serious influenza complications. It is available in Spanish, Vietnamese, Chinese, and Tagalog, as well as in English.
     
    To access a ready-to-print (PDF) version in ENGLISH, go to:
    http://www.cdc.gov/flu/pdf/keyfacts.pdf
     
    To access a web-text (HTML) version in ENGLISH, go to:
    http://www.cdc.gov/flu/keyfacts.htm
     
    To access a ready-to-print (PDF) version in SPANISH, go to:
    http://www.cdc.gov/flu/espanol/pdf/keyfacts.pdf
     
    To access a web-text (HTML) version in SPANISH, go to:
    http://www.cdc.gov/flu/espanol/keyfacts.htm
     
    To access a ready-to-print (PDF) version in VIETNAMESE, go to:
    http://www.cdc.gov/flu/vie/pdf/keyfacts-vietnamese.pdf
     
    To access a ready-to-print (PDF) version in CHINESE, go to:
    http://www.cdc.gov/flu/cht/pdf/keyfacts-chinese.pdf
     
    To access a ready-to-print (PDF) version in TAGALOG, go to:
    http://www.cdc.gov/flu/tgl/pdf/keyfacts-tagalog.pdf
     
  3. The web page "Questions & Answers: 2004-05 Vaccine Supply" was updated on November 5. To access the updated information, go to: http://www.cdc.gov/flu/about/qa/0405vaccinesupply.htm
     
  4. The web page "Questions & Answers: Testing" was updated November 4. To access the updated information, go to: http://www.cdc.gov/flu/about/qa/testing.htm
     
  5. The seven-page document "CDC Guidelines for Large-Scale Influenza Vaccination Clinic Planning, 2004-05" presents considerations on the following topics: leadership, human resources, clinic location, clinic layout and specifications, crowd management, security, and advertising.
     
    To access a ready-to-print (PDF) version, go to:
    http://www.cdc.gov/flu/professionals/vaccination/pdf/vaxclinicplanning0405.pdf
     
  6. The patient self-screening questionnaire "Patient Screening Form: Who Should and Who Should Not Get a Flu Shot?" is now available in Russian.
     
    To access a ready-to-print (PDF) version, go to:
    http://www.cdc.gov/flu/professionals/flugallery/pdf/vaccinescreeningform-rus.pdf
     
  7. The three-page "Fact Sheet: HIV/AIDS and the Flu" clarifies information about giving influenza vaccine and antiviral medications to people with HIV/AIDS.
     
    To access a ready-to-print (PDF) version, go to:
    http://www.cdc.gov/flu/protect/pdf/hiv-flu.pdf
      
    To access a web-text (HTML) version, go to:
    http://www.cdc.gov/flu/protect/hiv-flu.htm

CDC is continually adding information to its Influenza web section (including Q&A pieces for patients and professionals); visit it often by going to: http://www.cdc.gov/flu
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November 15, 2004
NEW: IAC ADDS A SECTION OF SPANISH-LANGUAGE RESOURCES TO ITS WEBSITE FOR THE PUBLIC

The Immunization Action Coalition recently added a page of Spanish-language resources to its website for the public, www.vaccineinformation.org The home page now features a link to "Información en Español," which brings interested visitors to a section of immunization materials in Spanish.

The "Inmunización" page includes immunization schedules for adults, adolescents, and children; 15 Vaccine Information Statements; print materials from IAC and other organizations; videos from CDC and the Vaccine Education Center; photos; Spanish-language websites related to immunization, viral hepatitis, and general health; and toll-free telephone numbers.

The Spanish-language resource page can be accessed directly by going to http://www.vaccineinformation.org/spanish.asp Of course, we encourage you to refer all your patients and parents with immunization questions to the website's home page: http://www.vaccineinformation.org
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November 15, 2004
DHHS ANNOUNCES CONTRACT TO SECURE FUTURE EGG SUPPLY FOR INFLUENZA VACCINE PRODUCTION

On November 9, the Department of Health and Human Services (DHHS) issued a press release announcing it has awarded a contract to ensure the egg supply needed to manufacture influenza vaccine in the event of a pandemic influenza outbreak or future vaccine shortage. Portions of the press release are reprinted below.

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November 9, 2004
For immediate release

SECRETARY THOMPSON ANNOUNCES CONTRACT TO SECURE FUTURE EGG SUPPLY FOR FLU VACCINES

HHS Secretary Tommy G. Thompson announced today the awarding of a contract to Sanofi Aventis Inc., part of the Sanofi Aventis Group, to ensure there are enough eggs on hand to manufacture flu vaccines in the event of a pandemic flu outbreak or future vaccine shortages.

This contract will ensure eggs are available to permit vaccine production at any time during the year, which will prevent gaps in flu vaccine supply due to inflexible, tightly planned manufacturing schedules, inadequate surge capacity, and dependency on foreign manufacturers. It also will provide for the stockpiling of other needed vaccine manufacturing supplies for ready availability.

"The existing flu vaccine manufacturing system is not adequate to meet the nation's needs in the event of a flu pandemic or a shortage," Secretary Thompson said. "This is an important step toward protecting Americans should a flu pandemic break out. . . ."

This contract follows Secretary Thompson's announcement in August of the National Pandemic Influenza Preparedness and Response Plan, which outlines a coordinated national strategy to prepare for and respond to an influenza pandemic. The draft plan may be found online at http://www.hhs.gov/nvpo/pandemicplan and is a result of years of work by the department.

The contract to Aventis Pasteur is nearly $10 million for the base contract to develop and implement the egg supply plan for transition to a year-round egg supply, to stockpile other vaccine manufacturing supplies, and to obtain initial investigational lots of pandemic influenza vaccine. Maintenance of the egg supply plan, which will provide an increased surge capacity for vaccine manufacturing, and more investigational lots of pilot pandemic influenza vaccines through 2008 may increase the overall contract value to $41 million. . . .

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To access the complete press release, go to:
http://www.dhhs.gov/news/press/2004pres/20041109a.html
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November 15, 2004
REMINDER: DECEMBER 1 IS THE DATE FOR CDLHN'S FREE SATELLITE BROADCAST ON VACCINE STORAGE AND HANDLING

Quality Assurance in Vaccine Storage and Handling, a live satellite broadcast, will take place on December 1 from 10AM to 11:30AM PT. Seating is limited for this free event, and registration at a viewing site is required. CDLHN does not handle registration. For information about registering with a facilitator at a viewing site in your location, go to: http://cdlhn.com/default.htm

The overarching goal of the broadcast is to help clinics and practices avoid handling and storage errors that can result in thousands of dollars in wasted vaccines. The broadcast will include a live Q&A segment and will present real-life scenarios that clinics and practices face every day. Topics that will be covered include vaccine storage equipment, temperature logging, and protecting vaccines in the event of storage problems or an emergency.

The intended audience includes physicians, nurses, physician assistants, and other personnel in hospital and outpatient settings such as nursing homes, chronic-care facilities, and assisted-living residences. It also includes personnel who provide home healthcare.

The California Distance Learning Health Network (CDLHN) and the California Department of Health Services, in partnership with CDC, are the broadcast producers.

For additional information, contact Kate Spilis at (619) 594-5912 (phone), (619) 594-7427 (fax), info@cdlhn.com (email), or http://cdlhn.com/default.htm (Web).

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-9131

This page was updated on November 16, 2004