# Incorporating Pentacel (DTaP/IPV/Hib) into provider orders during the Hib vaccine shortage

# 

We are entering the 9^th^ month of the Hib vaccine shortage that was
initiated by Merck's recall of their Hib-containing vaccines. We
continue to anticipate that Merck will be able to bring their Hib
vaccine back to the program and the private market in the fourth quarter
of this year. Once that happens, the allocation system will change and
greater choice will be possible.

**[Allocations]{.underline}**

As a result of the recall, sanofi pasteur is currently the only supplier
of Hib-containing vaccine for U.S. Fortunately, the licensure of
Pentacel adds more Hib-containing vaccine into the market, although not
enough to resume the booster dose of Hib vaccine.

A survey of grantees indicated that there are only a modest number of
"early adopters" of Pentacel. Because of the constraints caused by the
Hib vaccine shortage, and the limited early uptake of Pentacel, starting
in August, all immunization programs will receive a mix of ActHib and
Pentacel vaccines. The purpose of this message is to provide some
guidance on the incorporation of Pentacel into provider practices.

The amount of ActHib available on the federal contracts will be less
than we had during the first 7 months of this year. Grantees will
receive August ActHib allocations that are roughly 75% of their July
ActHib allocations. The decrease of ActHib will be more than made up by
the addition of Pentacel, as grantees will receive August Pentacel
allocations that are roughly 40% of their July ActHib allocation, for a
15% increase (from July to August) in total Hib-containing vaccine
doses. In addition, grantees will have the opportunity to request
additional Pentacel, above and beyond their allocation, by asking their
project officer.

On the following pages, we have included guidance for grantees in
integrating Pentacel into provider practices during this time. There are
many different strategies that grantees can use to incorporate Pentacel
into their program during the Hib vaccine shortage. The options
presented below are examples, and are not meant to be overly
prescriptive, since many grantees will want to find their own solutions.

We will also develop provider-level guidance on the use of Pentacel that
will be sent with the vaccine shipments containing Pentacel. This will
provide information about Pentacel and its proper use during the Hib
vaccine shortage.

**[Incorporating Pentacel]{.underline}**

For practices using single-antigen vaccines, transition to Pentacel is
relatively straightforward. These practices could begin using Pentacel
as the first dose in the primary series for their two-month olds.
Infants already started on single-entity vaccines can finish the series
with separately administered DTaP, IPV, and Hib vaccines. An alternative
is to switch all infants to Pentacel. See below for these options for
single-antigen practices.

For practices using Pediarix (DTaP/IPV/HepB), the situation will be more
challenging. Confusion and administration errors may result when both
Pediarix and Pentacel are in use simultaneously in the same practice.
These two combination vaccine are overlapping in DTaP and IPV, but
Pediarix contains HepB and not Hib, and Pentacel contains Hib, but not
HepB. For practices incorporating Pentacel, it is easiest to begin with
administration of Pentacel to their newborns, while infants already
started on Pediarix could finish the series with Pediarix.

Inventory management will be challenging in a practice that has both
Pediarix and Pentacel, and may result in vaccine wastage if inventories
are not monitored closely. The risk of children missing a dose of
hepatitis B or Hib vaccine increases when both products are available.
The following recommendations may help states avoid or decrease the
risks of improper immunization and vaccine wastage.

Some grantees have sufficiently high Pediarix use that some
Pediarix-using practices will need to receive at least part of their
Hib-containing vaccine as Pentacel. Therefore, this document will
provide guidance for both Pediarix-using and non-Pediarix-using
practices.

**When possible, it makes sense to**

-   Work with higher-volume providers to receive Pentacel to allow more
    targeted efforts to support providers making this change in their
    vaccine administration schedules

-   Preferentially incorporate Pentacel into practices that do not use
    Pediarix.

    -   Select implementation options that maximize the potential for
        inventory management and decrease the likelihood of vaccine
        administration errors.

For all options, grantees will want to carefully identify providers to
begin using Pentacel to ensure the best likelihood of success in
completing vaccination correctly, decreasing medical errors and limiting
wastage. The number of providers who begin using Pentacel may be
determined by the amount of Pentacel your project will receive, the
monthly Hib allocation of each provider, and the integration option you
select. Through careful provider selection, the number of providers and
children affected can be limited, and technical assistance and quality
assurance efforts by grantees focused. In some cases, a single large
provider may account for the entire amount of Pentacel being made
available to you. In other cases, the grantee may involve a number of
practices, selecting high volume providers with the best track record
for inventory management and accountability reporting.

**[Provider Identification]{.underline}**

-   Determine the number of doses of Pentacel your project will receive,

-   Identify the providers in your project who:

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-   Have a total aggregate Hib allocation equal the expected number of
    doses of Pentacel in your allocation.

-   Have a history of good inventory management and accountability
    practices.

-   Are not overstocked with Pediarix or single antigen vaccines.

**[For a practice that does not use Pediarix (two
options)]{.underline}**

-   Check the provider's current inventory for ActHib, DTaP, HepB, and
    IPV.

-   Patients ***[not]{.underline}*** needing DTaP or IPV (only needing
    Hib) vaccination should receive a single dose of Hib vaccine from
    the remaining ActHib inventory and other single component
    vaccinations as appropriate at that visit.

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-   If sufficient ActHib is on hand to cover patients seeking or needing
    only Hib vaccination, additional ActHib should not be ordered.

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-   If there is not sufficient ActHib on hand to cover patients
    anticipated to need or seek only single component Hib vaccination,
    determine the provider need and allow the provider to order enough
    ActHib to meet the need.

***Option 1: Use of Pentacel for children initiating the primary Series,
ActHib for those who have already started the primary series:***

-   Assure that the practice knows it is to switch, at least
    temporarily, to Pentacel.

-   Place approximately one-third of their next Hib-containing vaccine
    order as Pentacel (this proportion will increase for subsequent
    orders)

-   Decrease on a dose-for-Pentacel-dose basis one dose of DTaP, one
    dose of IPV, and one dose of ActHib.

-   The practice should start using Pentacel and hepatitis B vaccine for
    the first dose in the primary series (typically at the 2-month
    visit), and use the separate vaccines (ActHib, DTaP, and IPV) for
    babies that have started the primary series with the separate
    vaccines.

**Option 2: *Use of Pentacel for all doses in the primary series for
DTaP, IPV, Hib:***

-   Assure that the practice knows it is to switch, at least
    temporarily, to Pentacel.

    -   Place 100% of the provider's Hib-containing order as Pentacel.

    -   Decrease on a dose-for-Pentacel-dose basis one dose of DTaP, one
        dose of IPV, and one dose of ActHib.

    -   The practice should start using Pentacel and Hepatitis B for all
        doses in the primary series of DTaP/IPV/Hib and single antigen
        Hepatitis B for primary series hepatitis B vaccination.

        -   This will decrease confusion for the provider, as they will
            transition all children receiving the primary series of
            DTaP/IPV/Hib to Pentacel at one time.

**[For a practice that uses Pediarix:]{.underline}**

-   Complete a provider identification process.

-   Working with selected providers:

    -   Check provider's current inventory for Pediarix, ActHib, DTaP,
        HepB, and IPV.

    -   Give the provider guidance on how to manage the use of existing
        inventory while transitioning to Pentacel.

    -   Develop a plan for the use or redistribution of the provider's
        Pediarix inventory if necessary.

    -   Assure that the practice knows it is to switch, at least
        temporarily, to using Pentacel, and that the practice
        understands the challenge of having two overlapping combination
        vaccines in use at the same time.

-   Place approximately one-third of their next Hib-containing vaccine
    order as Pentacel (this proportion will increase for subsequent
    orders).

-   Decrease on a dose-for-Pentacel-dose basis one dose of Pediarix and
    one dose of ActHib.

-   Increase on a dose-for-dose basis one dose of hepatitis B vaccine.

-   The practice should start using Pentacel and hepatitis B vaccine for
    the first doses in the primary series for DTaP, IPV, Hib at the
    2-month visit.

-   Infants who started the primary series with Pediarix and ActHib
    should finish the primary series with Pediarix and ActHib.

**Updating VOFA**

> As soon as a contract price is available for Pentacel, grantees will
> be notified when the VOFA patch is available for download.  Grantees
> should download the patch as soon as possible and indicate how many
> doses of Pentacel they intend to distribute to providers in August and
> September, just as they would for all other vaccines.  Please note
> that grantees may order doses prior to completing the VOFA patch in
> order to ensure providers have sufficient supplies of hib-containing
> vaccines to serve their patients, but CDC requests that the VOFA patch
> be updated as soon as possible.
>
> When completing the VOFA patch, grantees who are not able to use state
> funds to purchase Pentacel at this time should purchase those doses
> using another funding source (VFC and/or 317).
>
> Grantees should ensure that they are not exceeding their total
> allocations of DTaP, and Polio, and will need to reduce the quantities
> of single antigen DTaP and Polio vaccines they intend to distribute in
> those months noted above.   In addition, grantees who currently use
> Pediarix and are planning to replace some of that use with Pentacel
> will need to add in doses of HepB.  In the event that a grantee is
> close to or has exceeded their total annual allocation of DTaP and/or
> polio, they should contact their monitor or Melissa Moore to discuss
> how best to address the matter.

This document can be found on the CDC website at:

<http://www.cdc.gov/vaccines/vpd-vac/hib/downloads/7-30-08-incorp-pentacel-508.doc>