SPECIAL POINTS OF INTEREST IN THIS EDITION
- Improving Vaccine Storage and Handling
- Monitoring Vaccine Inventory
- Don't forget booster doses!
- VFC Reminders
- April-May VFC Calendars
- New PCV13 VIS Available
- Immunization Updates
Provider Re-enrollment and Benchmarking Underway
Active, enrolled VFC providers should have received the certified mailing related to the 2013 VFC re-enrollment and “benchmarking” process. Providers are being asked to submit ALL doses administered in your clinic/practice during the month of April – include both VFC eligible AND non-VFC eligible by Patient VFC eligibility category and vaccine type.
This information must be compiled and submitted online. Provider Enrollment Agreement signature must be submitted via fax, email or mail.
The deadline to complete and submit all forms outlined in this packet is May 10th, 2013. Please retain a copy of all completed forms and keep on file at your office.
Flu Pre-Book is Complete
Pre-ordering for VFC flu vaccines for the 2013-2014 season wrapped up on February 28th. Thanks to the 447 of you who completed on schedule. If your clinic missed the pre-book opportunity you will have another opportunity in September .
Improving Vaccine Storage and Handling
Storage of vaccines is often taken for granted, when vaccines are probably one of the most expensive purchases a provider has to make on a regular basis. The average cost of purchasing one box of each of the vaccines for the childhood ACIP schedule runs around $12,000.00, and most providers order more than one box of each, when they do place an order! Add to that the “cost” of one box each of VFC vaccines at around $9,000.00 and you’ve got $21,000.00 tied up in vaccine for just one box of each!!!! The average monthly order of VFC vaccines placed by our ~580 enrolled providers totals around $3,000,000.00. You do the math!
That’s part of the reason that the CDC has started taking a long hard look at how providers in all 50 states, the District of Columbia, and the US Territories, store vaccine, and why they are cracking down on the types of units that are used to store vaccines supplied by the VFC program.
1. CDC is recommending that providers who use combination household refrigerator/freezers use only the refrigerator portion of the unit and NOT the freezer section for vaccine storage. They are recommending frozen vaccines be stored in a freezer unit such as a chest or upright deep freeze.
2. Providers who are enrolled, and are actively ordering vaccines from the VFC program are NO LONGER allowed to store vaccines (VFC supplied, especially) in the small dormitory style refrigeration units. This includes even short-term (day-time) storage.
NEW CDC Storage and Handling Guidance
Many of you by now have probably heard that the CDC has tightened the requirements and recommendations related to the types of vaccine storage equipment that providers should be using. The Vaccine Management Team/ VFC staff have been pouring over these requirements and recommendations trying to figure out how to best spread the news and offer suggestions to providers that ask about the new “stiffer” guidance.
1. Providers who are enrolled, and are actively ordering vaccines from the VFC program are NO LONGER allowed to store vaccines (VFC supplied, especially) in the small dormitory style refrigeration units. This includes even short-term storage. Temperatures in these types of units are too unpredictable and expose vaccines to wide temperature variations. This is the only recommendation that the CDC made a real requirement!
2. CDC is recommending that providers who use combination household refrigerator/freezers only use the refrigerator portion of the unit and NOT the freezer section for vaccine storage. They are recommending frozen vaccines be stored in a freezer unit such as a chest or upright deep freeze.
3. The CDC is also recommending providers begin using digital data logger thermometers which have detachable probes encased in glycol for monitoring temperatures of vaccine storage units. We understand that these types of thermometers are very expensive to purchase and to keep calibrated. There is also time involved in uploading the data and reviewing the data, in addition to the time it takes to train staff to do this. (All this in addition to continuing to do the twice daily temperature logs, like we’ve always done!)
Storage Do's and Don'ts
- Do organize vaccines by expiration date-shortest date first, longest dates last.
- Do keep vaccines centrally located in the unit, away from the sides and back.
- Do keep the lids on the vaccine boxes.
- Do keep separate VFC and Private vaccine stocks labeled.
- Do only keep a 30-45 day inventory of VFC vaccine in the unit. Less inventory on hand means less wastage if there is a problem.
- Do use open topped bins or baskets to organize vaccines. These allow air to circulate around the boxes!
- Do place the thermometer on the shelf next to the vaccine, in the middle of the unit, on the middle of the shelf.
- Do use approved vaccine storage units!
- Don’t remove the lids from boxes - vaccines are light sensitive.
- Don’t store in closed bins or drawers -
this doesn’t allow for good air flow around the vaccine boxes.
- Don’t store vaccines on the door- temperatures here are not stable.
- Don’t mix VFC and Private stocks.
- Don’t overstock the storage unit-there needs to be air flow around the boxes of vaccine.
- Don’t dump vaccines into bins or drawers-keep only one box “open” (with the lid in place) at a time. The boxes add an additional layer of protection against temperature changes.
- Don’t use dormitory style storage units.
- Don’t allow the thermometer to slip to the back of the refrigerator, and don’t allow it to sit too near the front.
These are many of the things that the VFC Site Visit Reviewers check during the yearly or bi-yearly site visits to providers. For more information on proper storage and handling of vaccines you can check out Chapter 5 of the “Epidemiology and Prevention of Vaccine Preventable Diseases, 12 edition (better known as The Pink Book).
To get you copy, request one from the VFC program at www.coloradovfc.com. When you log on, go to the Immunization Supplies Form, complete the request and one will be sent to you.
They are also addressed in the CDC’s new Storage and Handling Training available at http://www.cdc.gov/vaccines/ed/youcalltheshots.html
Improving Vaccine Inventory Control
The following information is an excerpt from the CDC’s “PINK BOOK” on ways to improve monitoring your vaccine inventory:
“A vaccine inventory should be conducted monthly to ensure adequate supply to meet demand. Vaccine diluents should also be included in the inventory to ensure adequate supplies are available. Determining factors for the amount of vaccine and diluent ordered include: projected demand, storage capacity, and current vaccine supply. Vaccine coordinators should request delivery during office hours. Each vaccine order should be updated to reflect any period of time the office will be closed, such as holidays or scheduled vacation time.
It is also important to avoid overstocking vaccine supplies which could lead to vaccine wastage or having outdated vaccine on hand. Vaccine and diluent expiration dates should be closely monitored. Rotate stock so that vaccine and diluent with the shortest expiration date are used first to avoid waste from expiration. If the date on the label has a specific month, day, and year, the vaccine can be used through the end of that day. If the expiration date on the label is a month and year, the vaccine can be used through the end of that month. A multidose vial of vaccine that has been stored and handled properly and is normal in appearance can be used through the expiration date printed on the vial unless otherwise stated in the manufacturer’s product information. Mark a multidose vial with the date it is first opened. Mark reconstituted vaccine with the date and time it is reconstituted. The expiration date or time might change once the vaccine is opened or reconstituted. This information is provided in the manufacturer’s product information. Expired vaccine and diluent should never be used and should be promptly removed from the storage unit.”
Providers should have seen the following two memos that were sent by the VFC program. Please copy them off, or check the Colorado VFC web-page, to get a printable copy for staff reference.
Things to Remember from VFC Operations
A Current Vaccine Order Form must be used each time an order is placed.
A Current Vaccine Return Form must be used each time vaccines are returned to the VFC program.
- Orders received on older forms will be voided and returned. (This is important because ordering is done by NDC codes, and older forms may have outdated NDC codes on them.)
- Order confirmations are sent via email.
All returns need to be entered into VTrckS by the NDC code.
ALL VFC vaccines in the refrigerator/freezer must be reported as inventory each time a vaccine order is placed!!! Orders received without all inventory being reported will be returned as voided.
- This means all inventory must be reported, whether or not you are ordering that vaccine! VTrckS will not accept orders unless ALL inventories are reported!
- Report all lot #(s) and expiration date(s).
- Do not combine total doses for all lot #(s) reported.
- Each lot # should have a corresponding number of doses.
Provider information on file in VTrckS must match the name of the individual(s) authorized to place orders in your office/clinic.
- The VFC Program must be notified prior to an order being placed if there has been a change in VFC contacts!
- Please complete a Change of Provider Information Form each time there is a change in VFC contacts.
- VTrckS will void an order if the individual completing the order is NOT listed in the system.
E-mail addresses must be current and accurate.
- Use a Change of Provider Information Form to update e-mail addresses.
MOVING? The VFC Program must be notified 30 days IN ADVANCE of the move.
General Immunization News
The following Q and A’s can be found in the “Ask the Experts” which is published monthly by the Immunization Action Coalition and located at www.immunize.org
Q: I understand that ACIP recently changed its definition of evidence of immunity to measles, rubella, and mumps. Please explain.
A: At its October 2012 meeting, ACIP voted to include “laboratory confirmation of disease” as evidence of immunity for measles, mumps, and rubella. ACIP voted to remove “physician diagnosis of disease” as evidence of immunity for measles and mumps. “Physician diagnosis of disease” had not previously been accepted as evidence of immunity for rubella. With the decrease in measles and mumps cases over the last 30 years, the validity of physician-diagnosed disease has become questionable. In addition, documenting history from physician records is not a practical option for most adults. The provisional MMR recommendations are currently available on the CDC website.
Q: We inadvertently reconstituted a vaccine with the wrong diluent and administered the vaccine. By the time we realized our error, the patient had already left the clinic. Do we need to revaccinate the patient? If so, when should we do it?
A: Yes, you need to revaccinate the patient. If an inactivated vaccine is reconstituted with the wrong diluent and is administered, the dose should be repeated ASAP. If a live virus vaccine is reconstituted with the wrong diluent and is administered, it can be repeated on the same clinic day. However, if you can’t get the patient back to the office that day, you need to wait at least 4 weeks to repeat the dose.
Q: What are the new ACIP recommendations for vaccinating pregnant women with Tdap?
A: In October 2012, ACIP voted to recommend that a pregnant woman receive Tdap vaccine during each pregnancy, even if the woman had received Tdap previously. The optimal time to administer Tdap is between 27 and 36 weeks’ gestation. Vaccination during this time maximizes maternal antibody response and passive antibody transfer to the infant. Women who have never received Tdap and who do not receive it during pregnancy should receive it immediately postpartum.
When a woman gets Tdap during pregnancy, maternal pertussis antibodies transfer to the newborn, likely protecting the baby against pertussis in early life, before the baby is old enough to have received at least 3 doses of DTaP. Tdap also protects the mother, making it less likely that she will get infected with pertussis during or after pregnancy and thus less likely that she will transmit it to her infant.
The related provisional recommendations for the use of Tdap in pregnancy were published on December 6, 2012. CDC published the final updated recommendations in the February 22 issue of MMWR (pages 131-135).
Q. A 7-year-old who needed a tetanus shot for wound management came into our emergency department. My question is, if a child has received the complete 5-dose series of DTaP but has never had Tdap, should the child receive Tdap or Td for wound management?
A. Neither. A child who has completed 5 doses of DTaP has by definition received the fifth dose on or after his/her fourth birthday. In this child’s case, it has been less than four years since receipt of the complete series, so the child does not need either Tdap or Td. The child is fully vaccinated against tetanus according to CDC tetanus wound management guidelines.
CDC Releases Updated VIS for PCV13 vaccine; Additional Document Available for Providers
On February 27, CDC posted an updated and simplified VIS for pneumococcal conjugate vaccine (PCV13). CDC revised the content to incorporate information associated with the new ACIP recommendations on vaccinating certain adults with PCV13. Providers may use up their existing stocks of the previous pneumococcal vaccine VIS, particularly when vaccinating children.
In addition to revising content, CDC also simplified the format to make the VIS easier to read. Information not relevant to the patient at the time of vaccination was removed (e.g., information regarding vaccine indications and catch-up schedules). CDC created a second document,Supplementary Provider Information: PCV13 VIS, designed as a quick reference for providers. It gives additional information about the vaccine, such as contraindications and precautions and links to pertinent ACIP recommendations. Providers can use the second document to answer patient questions. Starting February 27, supplementary provider information will accompany each new and updated VIS.
Note that the supplementary provider information document is linked from the PCV13 section of CDC's VIS web page as a Note to Providers.
Updated pneumococcal conjugate vaccine (PCV13) VIS
Supplementary Provider Information: PCV13 VIS
CDC's VIS web page
Tickets on Sale for SOUP! 2013
Purchase your tickets today for an evening of soup and celebrating!
The Colorado Children's Immunization Coalition's 6th annual SOUP!
(Shots Offer Unrivaled Protection) event will take place Monday, April 22, 2013 from 6-9 p.m. at History Colorado Center. The soup-tasting event will raise funds and awareness for childhood immunizations and honor the Big Shot of the Year, Seth Mnookin, author of The Panic Virus: A True Story of Medicine, Science and Fear and the 2013 Sure Shots, Emily Anderson and Christie Hage.
Tickets: $90 for Couple, $50 Individual, $35 for Professionals Under 35. Table Sponsorships are $500 and include 8 tickets to the event.
For more information, please visit www.childrensimmunization.org/soup.
Past editions of the Colorado VFC Update and all memos and
correspondence that were sent via fax can be reviewed on the Colorado VFC website. Just click on the Vaccines for Children topic link from
the navigation bar on the left side of the home page to be directed to
the VFC information.
Does someone else in your practice or agency want to get the Colorado VFC Review via email? Need to update your information?
Just email your name, title and practice name to
Debra Zambrano at firstname.lastname@example.orgThank you!