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Instructions & Explanations

STEP 1: Available Vaccines Table

To begin, the user must decide which vaccines will be considered by the algorithm, and which vaccine prices and other costs will be applied. This occurs by making choices and otherwise modifying the Available Vaccines Table. Later, in STEP 2, will be an opportunity to add new vaccines not already listed in the table.

Step 1A. Vaccine prices: Click one of the Set All buttons in the header of columns C, D, or E to select, for all products in the table, either public-sector Federal contract prices, or private-sector Average Wholesale Prices (AWP), or to activate text-entry boxes to type in custom prices individually for all vaccines. For vaccine products without a Federal contract price, the private-sector AWP will automatically be selected if the Set All button in the Federal price column header (column C) is clicked.

After the table refreshes itself, one may adjust the price for individual vaccines by clicking the radio button in each row for "Federal", "Private", or "Custom" prices. If "Custom" is selected, the price per dose must be entered in the box above. The price to be recognized by the algorithm is the one above the radio button which is selected.

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Public-Sector Federal Price Per Dose (Federal)

These prices are based on contracts between vaccine manufacturers and the Centers for Disease Control and Prevention's National Immunization Program, negotiated on behalf of public-sector state and local immunization programs. Prices in the table are those in effect as of the date indicated below columns C, D, and E. More recent prices published by the CDC may be found here. Purchases under this contract are available only to participating public agencies. Under the Federal Vaccines for Children program, some vaccines purchased at these prices are provided free to private physicians and other immunization providers for vaccination of certain entitled patients. Some vaccines on the immunization schedule have no Federal contract price. In such cases, the Private price is selected in the table for such products when the Set All button is selected in the Federal price column header (column C).

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Private Sector Price Per Dose (Private)

The default private sector prices in column D of the Available Vaccines Table are the Average Wholesale Prices (AWP), per dose, quoted in the 2001 Drug TopicsĀ® Red Book. The AWP serves only as a benchmark. Large drug wholesalers, drugstore chains, large health maintenance organizations, and other purchasers of vaccines direct from manufacturers will likely pay less than the AWP. Small pharmacies and clinics buying from wholesalers usually pay more than the AWP. (Reference: Kelly, WN. Drug Pricing. Chapter 4. In: Kelly, WN, ed. Pharmacy: What It Is and How It Works. Boca Raton, FL: CRC Press, 2001)

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Custom Price Per Dose (Custom)

The algorithm "custom" price entry box permits users to enter the actual prices quoted to them for vaccine purchase.

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Step 1B. Vaccines considered: The default setting is for the algorithm to recognize as available all vaccine products, in all packaging formats, which are U.S.-licensed to prevent the diseases targeted by the Recommended Childhood Immunization Schedule for all U.S. children. These are thus competed against each other by the algorithm. This default is represented by the checked boxes in the "To Be Considered" column H of the table.

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Step 1C. Hepatitis A vaccines: The algorithm excludes from consideration, by default, HAV vaccines, which are for general use only in states with high incidence of hepatitis A, according to hepatitis A recommendations of the CDC Advisory Committee on Immunization Practices (ACIP) (HTML version). To require the formulary to prevent hepatitis A, the user must check the box in the header of column H. This will initiate a refresh of the table, converting the box in the "To Be Considered" column H, from the default unchecked state to a checked state, for all vaccines containing HAV.

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Step 1D. Other Exclusions: Users may exclude en bloc from consideration by the algorithm all vaccines from specific manufacturers (column B), or all vaccines in certain packaging formats (column F). Doing so requires unchecking the corresponding check box in the Available Vaccines Table header. This causes a refresh of the table which results in unchecked boxes in column H for the corresponding vaccines. To exclude any individual vaccine products, uncheck the box in the "To Be Considered" column H.

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Manufacturers:

Abbreviations for vaccine manufacturers and distributors conform to the standardized nomenclature developed by the Vaccine Identification Standards Initiative (VISI):

AVP
Aventis Pasteur, Inc.
CHIR
Chiron, Inc.
GSK
GlaxoSmithKline plc.
MRK
Merck and Co., Inc.
WYE
Wyeth-Ayerst Laboratories, including Wyeth Laboratories and Wyeth-Lederle Vaccines.

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Packaging Formats:
"Liq/vial"
Liquid vaccine in a vial, requiring withdrawal by needle and syringe.
"Syringe"
Liquid vaccine in a syringe prefilled by the manufacturer, along with needle ready for administration.
"Powder"
Vaccine with a powdered (lyophilized) component requiring reconstitution with either diluent or a liquid vaccine from a separate vial.

Excluding vaccines by packaging

All vaccines of a particular packaging format can be included or excluded from consideration by the algorithm by checking or unchecking the boxes located in the Available Vaccines Table header, in the "Packaging" column F.

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Vaccine Types:

Vaccine abbreviations in column A conform to the standarized nomenclature developed by the Vaccine Identification Standards Initiative:

DTPa
Diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine
DTPa-HIB
Diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine, and Haemophilus influenzae type B conjugate vaccine
HIB
Haemophilus influenzae type B vaccine
HIB-HBV
Haemophilus influenzae type B conjugate, and Hepatitis B virus vaccine
HAV
Hepatitis A virus vaccine
HBV
Hepatitis B virus vaccine
INF
Influenza virus vaccine
MMR
Measles virus, Mumps virus, Rubella virus vaccine
PNUcn-7
Pneumococcal (Streptococcus pneumoniae) conjugate vaccine, 7-valent
POLIPV
Polio virus inactivated (injectable) vaccine
Td
Tetanus toxoid, and diphtheria toxoid (reduced antigen quantity for adults)
VAR
Varicella (chickenpox) (varicella zoster virus) vaccine

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Step 1E. Preparation Costs:The preparation cost represents the estimated cost of labor time, per dose, to open the vaccine packaging and prepare it for administration to the patient. These estimates may vary from user to user, and may be adjusted accordingly. It is varied here by packaging type. Default values are $0.25 for pre filled syringes, $0.75 for liquid vaccines in vials, and $1.50 for powdered/lyophilized vaccines. See references 1 and 3 in Background page for further discussion on these costs.

Preparation costs for all vaccines of a given packaging type can be set en bloc by using the text boxes and the Set All button at the top of the "Preparation Cost - $/Dose" column G of the Available Vaccines Table. One can also change the preparation cost of individual vaccines by modifying the text-entry box in column G of the row containing the specific product.

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Step 1F. Vaccine Wastage by Expiration:

Columns I and J of the Available Vaccines Table allow users to consider the effect of vaccine wastage by expiration. Default expiration lives are set to nominal values of 12 or 18 months that were obtained for various vaccine products from CDC personnel in charge of Federal vaccine purchase contracts. Default wastage rates of 1% and 0.75% have been assigned to these products, respectively, based on a 1% minimum wastage rate reported by studies on vaccine wastage (see Frequency and causes of vaccine wastage)

For each vaccine product, the user can enter a custom nominal wastage rate in column I. If the expiration life in column J is equal to the given default, the algorithm will use the nominal wastage rate provided in column I as the wastage rate for the particular product. Otherwise, it will proportionally increase or decrease the wastage rate from its nominal value according to whether the given expiration life is lower or higher than the nominal value, respectively.

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STEP 2: Add new vaccine(s)

Users can create and add new monovalent and combination vaccines for inclusion in the Available Vaccines Table. For each new vaccine, one-at-a-time, use the menu to select: (1) manufacturer, (2) purchase price per dose, (3) packaging type, (4) preparation cost per dose, (5) antigen(s) in this vaccine (multiple items permitted for a combination), and (6) ages when the product is approved for use. Click the Add Vaccine button to add the new vaccine for consideration. For additional vaccines, repeat this step.

HAV antigen is not yet in the add-new-vaccines menu because this prototype version of the software does not yet consider potential variation in the doses and ages of its use. These might vary from the algorithm's assumption of two doses at 24 and 30 months, according to ACIP recommendations and the current schedule.

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STEP 3: Visit Cost

The "Visit Cost" is the amount attributed for each separate visit to a vaccine provider. The default value is $40.00. The visit cost does not currently affect the vaccines chosen by the algorithm. To do so would require the use of some hypothetical vaccine which avoids the need for a vaccination visit otherwise required by the schedule. Visit cost may be set to $ 0.00 to exclude this cost from calculation by the algorithm of the overall cost of immunization.

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STEP 4: Injection Cost

The injection cost represents an estimate of the direct medical costs to administer each vaccine and/or the indirect and societal costs of deferred visits resulting from objection to multiple injections. The default value is $15.00. Injection cost also may represent the value to parents in avoiding extra injections for their children, and thus to reduce pain and suffering, as determined by willingness-to-pay studies. The injection cost amount affects the vaccines chosen by the algorithm by quantifying the extra value of combination vaccines which reduce the overall number of required injections. Injection cost may be set to $ 0.00 to exclude this cost from consideration by the algorithm.

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STEP 5: Acellular Pertussis Matching

The Advisory Committee on Immunization Practices (ACIP) states:

"Data are insufficient to document the safety, immunogenicity, and efficacy of using DTaP vaccines from different manufacturers in a mixed sequence. For this reason, the ACIP recommends that whenever feasible, the same brand of DTaP vaccine should be used for all doses of the vaccination series. However, the vaccine provider might not know or have available the type of DTaP vaccine previously administered to a child. Neither circumstance should present a barrier to administration of DTaP vaccine and any of the available licensed DTaP vaccines can be used to complete the vaccination series."

The algorithm defaults to the preference that the formulary will contain pertussis vaccines (e.g., in DTPa, DTPa-HIB, or other possible combinations) only from the same manufacturer. To remove this requirement and permit mixing of pertussis vaccines for different doses in the series, click to set the Do Not Match button.

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STEP 6: Perinatal HBV Dose

Scenario 1 requires the algorithm to schedule three doses of HBV, starting at age 2 months, and is the default setting. Scenario 2 schedules a perinatal outpatient visit (age "0-to-1 month") for the first HBV dose from the formulary, and the algorithm calculates the vaccine, preparation, visit, and injection costs for this dose. Scenario 3 assumes only two remaining doses of vaccine are needed by patients to be immunized from the formulary, and ignores all costs of the first HBV dose provided elsewhere.

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STEP 7: Save Settings

To save your customized settings in the Available Vaccines Table and in Steps 3 through 6, so that they need not be entered for future solution runs, enter a file name and click the Save Configuration button. To take advantage of this feature, you must have already logged in, or you can log in by entering your username and password in this section. This step can be skipped, if desired.

Retrieving saved configurations: Once the user has logged in, a list of saved configurations becomes available on the side bar at the left margin of the page. Selecting one of these configurations and clicking the Load button will restore the saved settings into the Available Vaccines Table and Steps 3 through 6.

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STEP 8: Solve formulary

To run the algorithm to solve for your formulary, click the Solve button. For your convenience in printing out or saving an electronic record, a complete summary of the Available Vaccines Table and all its selected and customized settings will be provided along with your solution, which will appear in a separate browser window.

The Solution window will include:

(1) a table that specifies the vaccines (by brand) that will be administered at each age (visit), and the per-visit and total costs of vaccines, injections, preparation, and visits;

(2) a list of all vaccines that were competed by the algorithm -- whether selected or not -- including the user's settings for their prices and preparation costs, and for the injection and visit costs, and other algorithm choices; and

(3) a "shopping list" detailing the number of vaccines to purchase, by vaccine type and manufacturer, for each hypothetical child to be immunized by the formulary.

Four requirements must be met in order for a specific vaccine to be considered by the algorithm:

(1) The To Be Considered check box in column H of the corresponding row must be checked.

(2) One of the radio buttons in columns C, D, or E must be selected in the row containing the specific vaccine, and a price must be shown above the selected button. For Custom prices, the user must enter a positive number in the text field above the Custom radio button in column E. This field may not be editable unless the user first clicks the Custom radio button. For Added Vaccines, the price entered by the user is treated as a Custom price; therefore the Custom button is selected and locked for these vaccines.

(3) For Custom prices and for added vaccines, the entered price must be in the range $0.00 to $299.00. This upper limit helps minimize typographical errors. For example, it avoids a vaccine price entered erroneously as $300.00, instead of the intended $30.00.

(4) A preparation cost in the range $0.00 to $19.00 must be entered in column G.

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ERROR MESSAGE CAUSES: When the user initially loads the page, the buttons on columns C, D and E are unselected for all rows. Before the algorithm may be run, every row for which the check box in column H is checked must satisfy requirements (2), (3), and (4) above.

At present, the algorithm defaults to include all available vaccines which may satisfy the Recommended Childhood Immunization Schedule. However, the user may exclude all vaccines capable of satisfying one of the requirements in the schedule. This will result in a warning message on the solution page. In such cases, the formulary will satisfy only the diseases represented by the remaining antigens considered. For example, if all HIB, DTPa-HIB, and HIB-HBV vaccines are excluded, the formulary will fail to satisfy the requirement to prevent haemophilus influenzae type b disease. The algorithmn will produce NO results ONLY when no vaccines are considered or when the considered vaccines do not satisfy the requirements of the schedule for all antigens present in the considered vaccines.

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Version Beta 8.0