June 2003
Carol Ruppel (
cruppel@ecbt.org)
This month Congress has been engaged in cutting taxes; forging
Medicare prescription drug coverage proposals; deliberating a
childcare tax credit; writing a bill to make changes in court
jurisdiction for class action lawsuits and deliberating the
Senate omnibus energy bill. An agreement was reached between
the White House and the Republican House and Senate leadership
to add funds to 2004 appropriations for domestic discretionary
programs because the agreed-upon budget resolution was too
small to satisfy appropriators. (How the money was “found,”
is, fortunately, not ECBT’s business.) Thus, allocations were
made for the appropriations subcommittees, which begins the
process.
Efforts to keep immunizations on the radar screen were led by
Senators Reed (D-RI), Durbin (D-IL), Jeffords (I-VT) and Smith
(R-WA) and furthered by colleagues Senators Murray (D-WA),
Chafee (R-RI), Lincoln (D-AR), Wyden (D-OR), Landrieu (D-LA),
Lieberman (D-CT) and Clinton (D-NY). The senators will be
sending a letter to the Senate Appropriations subcommittee on
Labor, Health and Human Resources and Education. The letter,
addressed to subcommittee Chairman Arlen Specter (R-PA) and
Ranking Member Tom Harkin (D-IA), requests increased funds for
the state immunization (“317”) grants. We urge you to thank
your senators if they've signed on to this letter or to
contact them to ask that they do.
We encourage you to make your own brief arguments—not only for
this communication with your Senators but also for future
communications with both House and Senate members. Why does
your state need more funding both for vaccine purchase and for
operating the immunization program? Here are some of the
points we make when we meet with Senate and House members:
• Vaccine shortages have ended. Therefore there will
be a greater demand at clinics that administer
317-purchased vaccines.
• This year flu vaccine was added to the Recommended
Schedule for certain pediatric populations.
• Clinics are asked to administer adult immunizations
but are not funded to purchase vaccines for needy
adults.
• Immunization prevents illness which not only causes
suffering but costs money.
• The principal source of immunization registry
funding is the 317 grant, and your registry is at a
point (explain) where this money is desperately needed.
Immunization registries, when fully developed, provide
accurate immunization records at much less cost; prevent
costly over-immunization; allow for easier disease
surveillance; inventory vaccine supply; generate
reminders to patients that immunizations are due; help
providers monitor their own immunization rates and help
areas monitor their population's rates.
• Your state may be one of the 19 states that last
year was unable to purchase pneumococcal conjugate
vaccine for its clinics. Yet the vaccine is wildly
popular because of the disease burden it relieves. It
prevents 50 percent of all bacterial meningitis, 85
percent of bacterial blood infections and 7,000,000
cases of ear infections each year.
We will keep you apprised each month of the status of
appropriations bills so that you can take the necessary
action.
On May 14 Congressman Gene Green (D-TX) introduced H.R. 2095,
the Comprehensive Insurance Coverage of Childhood Immunization
Act, the same bill he'd introduced in the 107th Congress. The
bill would require that ERISA-governed and public employee
health plans pay first-dollar coverage for all recommended
childhood vaccines. So far he has 13 cosponsors: Congressmen
Quinn (R-NY), Pallone (D-NJ), Berman (D-CA), McDermott (D-WA),
Sandlin (D-TX), Evans (D-IL), Brown (D-OH), Waxman (D-CA),
Miller (D-CA), Gutierrez (D-IL), Bell (D-TX) and Wexler
(R-FL). Congressman Green and ECBT would appreciate your
contacting your House member to ask that (s)he also cosponsor
this bill. Although there are only estimates as to the number
of children affected, we believe that all health insurance
plans should fully cover childhood immunizations. This bill
would not affect state-regulated (“non-ERISA) health insurance
plans.
Finally, the Improved Vaccine Affordability and Availability
Act sponsored by Senate Majority Leader Bill Frist (R-TN) is
lying dormant while Medicare takes up staff time. This is the
bill that addresses vaccine stockpiling, manufacturer notice
to CDC for discontinuing production, increased emphasis on
adult immunizations, vaccine research and amendments to the
Vaccine Injury Compensation Program. We will keep you
apprised of any actions on this bill as well.
Burton Press Release
Expertly Misleads Both The Press And The Public
by Rich Greenaway
On May 1, 2003 a press release originating from the office
of Congressman Dan Burton (R-IN) indicated that he would join
a panel of scientists, medical researchers, and parents who
were convening from across the nation in Chicago, IL to
present evidence from recently or soon-to-be released studies
linking autism with the mercury-based preservative
thimerosal. Part of the premise for Representative Burton’s
press release was his statement that the 2003 Physicians Desk
Reference (PDR) showed that there are three vaccine
manufacturers who are still making childhood vaccines with
full doses {his term} of thimerosal. Specifically, his press
release of May 1, 2003 stated:
“The 2003 Physicians’ Desk Reference shows that there are
three vaccine manufacturers who are still making childhood
vaccines with full doses of thimerosal. These are as follows:
the Diphtheria-Tetanus-acellular-Pertussis (DTaP) manufactured
by Aventis-Pasteur in multi-dose vials contains 25 micrograms
of mercury; the Haemophilus-influenza-Type b (Hib TITER) in
multi-dose vials manufactured by Wyeth contains 25 micrograms
of mercury; and the pediatric hepatitis B vaccine manufactured
by Merck contains 12.5 micrograms of mercury. These vaccines
represent approximately half of the childhood vaccines
currently available for use in the United States.”
After reading the press release, ECBT immediately went into
full research mode to find out if Burton’s information was
true. Were thimerosal-containing childhood vaccines still
listed in the 2003 PDR and did that mean that they were still
available in the marketplace? We found out that only one
truth was contained in the above quote from Congressman
Burton’s press release. That one and only truth is that the
above mentioned thimerosal-containing formulations of the
childhood vaccines are still listed in the 2003 PDR. The
fallacies or misleading points in his statement are “that
there are three vaccine manufacturers who are still making
childhood vaccines with full doses of thimerosal”; that “these
{thimerosal-containing} vaccines represent approximately half
of the childhood vaccines currently available for use in the
United States.” The reality is that the thimerosal-containing
formulations of those vaccines listed in Burton’s press
release are no longer in manufacture or distribution in the
United States and haven’t been for years. Nor are they
available for use in the United States.
In an effort to better understand how a vaccine could be
listed in the most current PDR showing that it contains
thimerosal when it is no longer manufactured as such, we
contacted PDR directly and asked how the information in their
reference books is kept current.
The PDR is published yearly by Thomson Healthcare in Montvale,
NJ. Manufacturers pay to have their products listed in the
PDR and a free copy of the PDR is distributed to office-based
physicians. Not all medical products are found in the PDR
because a manufacturer may decide for whatever reason not to
list a product. Product information found in the PDR comes
directly from the manufacturer and is identical to the latest
package labeling as approved by the FDA for that product. No
changes to content are made by PDR. PDR may reformat the
layout of the information but final formatting and content is
approved by the manufacturer before PDR goes to print to
insure that PDR’s reformatting does not change the content
from the original.
Manufacturers have flexibility to make changes to the
information on their product in the PDR without submission of
those changes to FDA if the new information is considered a
“negative” change. Negative changes include new warnings
about their product, or new findings that would reflect
negatively on its use. Changes of information that would be
considered “positive” include information that would further
promote or serve to increase use of the product and those
changes must be submitted through FDA for approval before they
can be inserted into the next PDR edition.
Manufacturers can decide at any time to discontinue
production, however, once a manufacturer makes such a decision
it is not uncommon for them to keep the information in the PDR
for at least a couple of years. The reasons for doing this
are varied. Having unexpired product still available in the
market, or a recommendation from legal council that a product
listing be maintained are but two of the many potential
reasons why essentially outdated information may still be
maintained in the PDR.
In the case involving this press release, three vaccine
manufacturers sited by Burton decided to continue to list
descriptions of products in the PDR that they have removed
from the U.S. market. ECBT is not privileged to know their
reasoning for doing this. We just hope that in the future,
Congressman Burton will first investigate further before using
misleading information like this as such a major focal point
in his press release.
For Fast Relief, Try Immunization Registries!
by Amy Pisani, MS
Executive Director, ECBT
Published in the May 2003 NASN Newsletter, the official
publication of the National Association of School Nurses.
Reprinted with permission.
Immunization assessments are one of the many tasks required
of school nurses each year. While this record keeping is
vital to ensure that school children remain protected from
vaccine preventable diseases, time is better spent attending
to the growing number of health care needs of school children.
Through the advent of immunization registries, the burden of
manually assessing immunization records is becoming a thing of
the past. These confidential, computerized information
systems contain vaccination histories and provide immediate
access to a child’s current shot status. As families move in
and out of public and private health care systems, parents and
providers are able to access a central source of information
on each child, eliminating the need to obtain records from
previous providers. Registries make it easier for parents to
get their child’s shot record for childcare, school or camp
enrollment.
School Nurse Emily Grimes is responsible for assessing the
immunization status of the students enrolled at Friendship
Edison Public Charter School’s Chamberlain Campus in the heart
of Washington, D.C. With the passage of new regulations last
year requiring that every child’s record be assessed, this
already daunting task became an overwhelming responsibility.
It was discovered that more than 21,000 of the school system’s
68,500 students were not properly immunized. The district’s
authorities declared that within thirty-days every child would
need to prove compliance or risk expulsion from school. This
meant that 1,900 children had to be vaccinated every day,
seven days a week, for thirty-days. School nurses and the
Department of Health became true partners in this endeavor and
with the help of the immunization registry, came close to
accomplishing the goal. “I don’t know what I would have done
without the registry. You wait and wait for parents to bring
in the records,” stated Nurse Grimes. “Parents are confused
about the need to bring in records of booster shots. Getting
the record of the age five Hepatitis B vaccine is the biggest
challenge because parents believe that after providing the
immunization records when initially enrolling their children,
that they are all done. The registry saved me time and a lot
of aggravation!” Now, each month the schools provide the
Department of Health with a computerized enrollment record.
These records are matched with the immunization registry and
reports are generated listing each student’s current
vaccination status and non-compliance lists. As school nurses
attain additional records from parents, they are forwarded to
the registry staff and updated in the system. This becomes a
win-win for both the schools and health care providers by
creating more accurate records.
In 1999 the school district in Wausau County, Wisconsin
estimated spending 56 hours sending out immunization cards to
parents, 90 hours entering immunizations reported by parents
into their own system, 25 hours filing cards, 95 hours
generating non-compliance letters to parents and 30 hours
calling immunization providers to attain records. The school
district had a student database for immunizations, however it
was not linked with the healthcare providers in the area In
the Fall of 2000, Wausau began a pilot project to integrate
the student records with the local registry called the
Regional Early Childhood Immunization Network (RECIN). Before
integrating the two systems, school personnel had to call
student’s providers to track down the records, and then enter
them into the school system’s database. Julie Willems Van
Dijk, Director of Preventive Health Services for Marathon
County and a member of the Wausau School Board hailed the
system integration. “Reports required soon after school
starts took days to create. With RECIN it takes just a few
minutes for the same report.” The 95-hour task of generating
non-compliance letters was reduced to one hour. Wendy
Garlitz, RECIN System Coordinator found that many children
were not fully protected. She stated that “many children had
the correct number of immunizations, but they did not have
them at the right ages to be fully protected against disease.
When (school) staff checked records manually, they did not
catch the error. RECIN, programmed to comply with state law,
does catch those errors.”
Providers greatly benefit from registries as well. The
Centers for Disease Control and Prevention estimates that the
cost to manually retrieve, review, update and refile each
record is $14.50. Assuming that every child would require at
least one record pull in the first five years of life for
entry into school, All Kids Count estimates a total cost of
$58 million per year based on the annual national birth cohort
of 4 million (Horne, Saarlas, & Hinman, 2000). There are many
other important offsets to consider such as the reduction in
the number of over-immunized children. Data from the 1997
National Immunization Survey indicated that 21% of 19 - 35
month old children received at least one dose of vaccine they
did not need, at a national cost of $26.5 million per year
(Centers for Disease Control and Prevention, 1997). While
research is ongoing regarding the cost savings that would be
incurred by schools, Minnesota estimates a $5 million cost
offset.
Although immunization registries are currently under
development in every state, not all are fully operational at
this time and may not be able to link to schools. Schools
that wish to gain access to automated immunization data should
contact their local health department, to determine whether a
registry is available in their locale and how the schools can
collaborate. In addition, legal considerations regarding
access and consent must be dealt with. For example, while
some schools have the authority to log on directly to
immunization registries only to view student records, others
may be permitted to both view and update the records. In
other instances schools would not have direct access to the
registries, but would instead be provided with a printed
listing of children’s records and compliance status. Family
Educational Rights and Privacy (FERPA) Regulations also must
be considered.
In a letter to Every Child By Two, Former Secretary of
Education Richard W. Riley hailed plans to link registries to
schools, stating that “the automatic printout of a student’s
immunization status will promote greater accuracy of records
and avoid duplication of immunizations. This will enable
school officials to focus on other important health-related
activities.” Clearly, schools and registries are a winning
combination.
For more information on immunization registries and Every
Child By Two’s ongoing efforts to ensure timely immunizations
of children, please go to www.ecbt.org <http://www.ecbt.org>
or email at info@ecbt.org <mailto:info@ecbt.org>
References:
Horne, P.R., Saarlas, K. N., & Hinman, A. R. (2000). Costs of
immunization registries: Experiences from the All Kids Count
II projects. American Journal of Preventive Medicine, 19(2),
94-98.
Center’s for Disease Control and Prevention. (1997).
National immunization survey. Retrieved February 14, 2003
from the World Wide Web:
<http://www.cdc.gov/nip/coverage/default.htm#NIS>
Spring Break in New Mexico!
by Amy Pisani
ECBT Cofounders Rosalynn Carter and Betty Bumpers traveled
to New Mexico this year for Infant Immunization Week to bring
attention to a major crisis. At 61%, New Mexico boasts the
lowest immunization rate in the country…but not for long. The
newly formed New Mexico Immunization Coalition will be
coordinating efforts to ensure positive progress towards
raising those rates. First Lady Barbara Richardson, a
long-time friend and fellow advocate of Mrs. Bumpers, will
serve as the Honorary Chair of the coalition. Her enthusiasm
is clearly contagious. Patricia Montoya, New Mexico’s
Secretary of Health is a former school nurse and served as the
Director of the Agency for Children and Families under the
Clinton Administration. She will lead the newly formed
Children’s Cabinet that includes secretaries from several
agencies, including the Agency on Aging. Improved
immunization delivery will be a priority issue for the
Cabinet. The Agency on Aging, headed by Michelle Grisham will
enlist seniors to spread the important message about
immunization. New Mexico has one of the fastest growing
senior populations. About 300,000 older adults reside there,
and more than 46,000 live in a household with at least one
grandchild. More than 10,000 of these seniors are active in
the Aging Network and 226,000 are active members of the AARP.
Grisham is eager to make a difference in the lives of both the
seniors and the children of New Mexico and plans for this
collaboration are well underway.
Our cofounders spent two whirlwind days traveling between
Albuquerque and Santa Fe, along with First Lady Richardson,
Agency Secretaries, Lt. Governor Diane Denish and key
immunization personnel to commend that which is already being
done and to support plans for the future. Included at many of
the events were Senators, Representatives and other government
officials that can play a crucial role in creating sound
public policy to help achieve optimal health care coverage for
children. Print and media coverage was impressive.
Included in the strategic plan is New Mexico’s “Done By One”
Campaign, a joint effort of the New Mexico Medical Society and
the New Mexico Department of Health. This includes a
user-friendly, abbreviated immunization schedule that
eliminates the ranges in which one can receive a vaccine
(these appear as bar graphs on the current ACIP/AAP/AAFP/CDC
schedule), while respecting the necessary intervals between
doses of vaccine (see attached). Nationwide immunization
rates tend to drop at the 18 – 24 month range. Reasons for
the drop in rates is an issue that receives great attention
nationwide, with little results. By consolidating the
schedule, New Mexico’s health advocates hope to better protect
their children from vaccine preventable diseases by age one.
Cofounder Rosalynn Carter humorously remarked that if this new
schedule is a success we just might have to change our name to
“Every Child By One”! Carter and Bumpers committed to making a
return trip to celebrate New Mexico’s achievements, which will
include the creation of a statewide immunization registry in
the near future.
For more information about the “Done By One” campaign or to
receive a copy of the Intergenerational Immunization Outreach
Project Proposal, please contact Barak Wolff at 505/827-0219
BarakWolff@doh.state.nm.us
Last Call For Abstracts
Online submission of abstracts for the 2003 Immunization
Registry Conference is midnight Tuesday, June 17, 2003. The
conference is being held October 27 - 29, 2003 at the Crowne
Plaza Ravinia hotel in Atlanta, GA. Go to
http://cdc.confex.com/cdc/irc2003/ to visit the abstract
submission website. For general information on the conference
go to
http://www.cdc.gov/nip/registry/irc/.
Did You Know...
The CDC published a Notice to Readers,
"Pneumococcal Conjugate Vaccine Shortage Resolved," back in
the May 16 issue of the "Morbidity and Mortality Weekly
Report" (MMWR). The MMWR notice can be found at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5219a6.htm.
Receive Morbidity and Mortality Weekly Report (MMWR)
FREE via Email. Sign up by going to
http://www.cdc.gov/subscribe.html
