Presentation on theme: "Vaccine Storage and Handling Update"— Presentation transcript:
1 Vaccine Storage and Handling Update Jackie Nelson, CoordinatorVaccines for Children ProgramWisconsin Division of Public HealthImmunization ProgramIntroduce state staff, Thank You for the Oppurtunity
2 Why all the fuss over storage and handling? What’s in your storage unit?So I know many of you have seen me a lot over the last several months and you may be asking, why all the fuss over the vaccine storage and handling. Let me tell you why.2
3 Number of Vaccines in the Routine Childhood Immunization Schedule 1985 (7)1995 (10)2005 (14)2012 (16)MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioMeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant)Hepatitis BVaricellaMeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant)Hepatitis BVaricellaPneumococcal DiseaseInfluenzaMeningococcalHepatitis AMeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant)Hepatitis BVaricellaPneumococcal DiseaseInfluenzaMeningococcalHepatitis AHPVRotavirusBecause the practice of immunization has truly become a science over the last 25 years from 7 in 1985 to 10 in 1995 to 14 in 2005 to 16 in So no wonder the administration, storage and handling has become so complicated and so very important. How many of you have seen any of these diseases? Probably not many because of the successes of our collective immunization efforts.3
4 How much money is in your storage unit? The cost of one box of each vaccine that is universally recommended for children & adolescents by purchase sourceVaccines included:DTaP (Infanrix), HepB (Engerix), Comvax,Hib (pedvax), Rotavirus (Rotatech,)PCV13,e- IPV, Flu, MMR, Varicella, HepA (Vaqta), MCV (menactra), Tdap (Boostrix), HPV (Gardasil), Kinrix, Pediarix, Pentacel1 box of Varicella Private $870.951 box of VaricellaVFC $724.90Two boxes of Varicella$Private Stock$VFC Stock $All vaccine in fridge $16,227.204
5 Success of Immunization Strategies Dramatic decrease in vaccine preventable diseasesTetanus, Haemophilus influenzae type b (Hib), Chicken Pox, MeaslesEradication of many diseases in the USSmallpox, Diphtheria, PolioWe have had a lot of successes with reducing or eliminating many debilitating VPD’s. Infact, the World Health Organization has said that immunizations has been one of the greatest public health interventions next to clean drinking water, of rhe centry. So thank you to all of you who have had even the slightest role in vaccinating and protecting our children and now many adults. We have done so well at decreasing VPD that many parents and health professional have never seen many of these diseases. This is a good thing, a very good thing but it makes our job alittle harder. Now our challenge is in maintaining high immunization rates with safe and effective vaccines. We know that when vaccine is not properly stored or handled there is a possibilty the vaccine will loose it potency nd effectivness. This is where the provider comes in. Asyou recive vaccine in your practices are responsible for protecting it so that it when it is adminsitered it does what it is supposed to do. Additionally, vaccine is very expensive any wher from whether it is provided to you from the state VFC program or privatley purchased. The cost per dose of vaccine can range from $9 for 1 dose of Hep B to $120 for everyone of the 3 dose series of HPV. We all have a responsibilty to protect the vaccine and frankly that is why I am here today. You probably have heard that we ae looking at a pretty significant vaccine loss here at your facility and we would like to take that experience and make it a learning oppurtuity. So the remining of this presentation with focus on the quidelines of proper storage and handling of all vaccine. ovawe will review some of the have to assure that the vaccine that our children are receiving provided the optimal amount ojk
6 Office of the Inspector General Report Study was conducted in April/May 201145 VFC providers from the 5 largest GranteesCompleted a site visit which included interviews with staff, observation of vaccine management, 2 week study of temps and final interview with grantee staff
7 What did they find?76% of the 45 selected providers had temperatures out of range during the two week period.16 of 45 providers had expired vaccines in their refrigerators.0 of 45 providers met the vaccine management requirements in the 8 required areas.
8 What Does it Mean to Me?CDC will be coming out with more strict requirements on vaccine storage and handling.Thermometers should be the type that are fluid filled in glycol.Site visits need to be more focused.
9 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
10 1. Maintaining Recommended Storage Temperatures The “Cold Chain” – Vaccines must remain at proper temperaturesManufacturer to distributorDistributor to office/clinicOffice/clinic to patient
11 1. Maintaining Recommended Storage Temperatures Vaccines stored in the refrigeratorTemperature range is 35-46º F (2-8º C)Store in middle of unit with air flow around vaccines to keep from freezingFrequent opening may cause temperatures to fluctuateWater bottles should be placed in the unit to help stabilize temperatureAssure the door is always closed and sealed
12 1. Maintaining Recommended Storage Temperatures Vaccines stored in the freezerTemperature range is 5ºF (-15ºC) or colderDo not allow frost/ice build-up to take placeEnsure door remains closed and sealedIce packs should be placed in the unit to help stabilize temperatureCheck all vaccines to ensure you do not exceed “thaw” timesDo not refreeze vaccineAdd ice pack under Varicella vaccine
13 1. Maintaining Recommended Storage Temperatures Frost build-up example
14 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
15 2. Vaccine Storage Requirements Home-style combination refrigerator/freezer is acceptable only if each compartment has a separate doorSeparate controls are highly recommended, but not requiredRefrigerators without freezers and stand-alone freezers usually perform better, e.g. pharmaceutical typeUnits must maintain required temperatures year-round
16 2. Vaccine Storage Requirements Unacceptable storage unit with 1 door for fridge and freezer accessPermitted storage unit with separate doorsSeparate controls highly recommended
17 2. Vaccine Storage Requirements Do not store vaccine near cold air outlet from the freezerStore vaccine centrally in the refrigerator and never in the door or vegetable binsMust allow 2 inches in between the walls of the unit and the vaccine boxes
18 2. Vaccine Storage Requirements Expired vaccine must be removed from units containing unexpired vaccineUnit must be big enough to hold largest inventoryUnit must be dedicated to the storage of biologics (no food or beverages)Must be big enough to hold largest inventory- think about flu season
19 2. Vaccine Storage Requirements Always store vaccines in their original boxesDo not remove vaccine from box to place in separate storage containersStore vaccine in their boxes. DO NOT DO THIS!!
20 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
21 3. Temperature Monitoring Measure temp of refrigerator and freezer twice daily (am and pm) with a certified, calibrated thermometerThermometers should be certified by the National Institute of Standards and Technology (NIST) and calibrated regularlyThermometers should be placed next to the vaccine in a central location in the storage unitIf temperature is out of range, immediately report to supervisor and record corrective actionTake additional temperature measurements to ensure that temps are again within range
22 3. Temperature Monitoring Record temperature of refrigerator and freezer twice daily (first thing in the morning and at the end of the day) on temperature logReview temp logs at least weeklyFax temperature logs monthly to the Wisconsin Division of Public Health ( )Keep logs for 3 years
25 3. Temperature Monitoring One person should be assigned the primary responsibility of measuring and recording temperaturesA back up person should be assigned in case the primary individual is unavailableAll staff working with vaccines should be familiar with proper temperature monitoring and recording
26 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
27 4. Vaccine ManagementState Supplied vaccine must be ordered through the Wisconsin Immunization Registry (WIR)Count and record current inventory before ordering vaccines through WIR (doses, lot # and expiration date)Vaccines are shipped Monday through WednesdayImmediately upon arrival, place vaccine in appropriate storage unitsIf there is a problem with the vaccine order report it to the VFC program within one hour of vaccine receipt
28 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
29 5. Vaccine RotationBefore new supply of vaccine is ordered, check current supply and order enough vaccine to cover a 2 month period.Rotate stock—short dated vaccines should be used first.Attempt to locate a VFC provider to transfer short dated vaccine before it expires.After three attempts and you still need assistance, contact Jane Dunbar at
30 Vaccine Storage and Handling 6 Focus Areas Maintaining Recommended Storage TemperaturesVaccine Storage RequirementsTemperature MonitoringVaccine ManagementVaccine RotationCommon ErrorsSo for the remainder of the presentation today we will be focusing on these 6 very important areas.
31 6. Common Errors Storage unit doors are not properly closed and sealed Check refrigerator and freezer doors frequentlyWhen the clinic opensClose if left open during the day; check temps if found openCheck before going home for the dayCheck on last business day of the week (e.g. Friday night) before clinic closes for weekendCheck first thing on Monday morning
32 6. Common Errors Vaccine inventory expires Order vaccines carefully to ensure vaccines do not expireCount inventory before orderingOrder only a 2 month supplyAttempt to locate a VFC provider to transfer short dated vaccine before it expiresDo not store expired vaccines with unexpired vaccines
33 6. Common ErrorsUpon arrival, vaccines are not inspected and immediately storedInspect vaccines on arrivalImmediately unpack and store vaccinesIf vaccines are damaged, contact the VFC program within one hour of receiving shipmentLynette Hanson, orIt is imperative that vaccines are checked immediately upon arrival. If the damaged vaccine or the error on the order is not reported by us within an hour after receipt at your facility, McKesson is not under any obligation to replace the order.
34 6. Common Errors Improper handling of compromised vaccine If state supplied vaccine is compromised you must call the WI Immunization Program for guidanceDo not throw away compromised vaccineDo not use compromised vaccine until the viability of the vaccine has been determinedIn the event of a power outage, if you are able to determine the duration will only be for a short time, do not remove vaccine and keep the door closed until power is restoredUse your emergency storage and handling plan to prevent vaccine from being compromisedIt is a requirement of the Vaccines for Children Program that you have an Emergency Plan in place so vaccine can be moved to another location if warranted.
35 Common Errors in Wisconsin In 2010, the most common errors found duringVFC Site Visits were:Providers recorded temperatures in the gray area(out of range) of the temperature chart anddid not do anything to address the problem.Approximately 17 sites had non workingthermometers in their refrigerator units.
36 Common Errors in WI (cont) 70 providers (out of 300) (public and private) did not have written procedures in all 8 required areas which include emergency response.-Designation of primary vaccine coordinator and at leastone backup staff-Proper vaccine storage and handling written plan-Vaccine Shipping (includes receiving and transport)-Procedures for vaccine relocation in the event of anemergency-Has the emergency plan been reviewed and updated in thepast year-Vaccine ordering-Inventory control (stock rotation)-Vaccine wastage
37 Common Errors in WI (cont) Providers did not have certified/calibratedthermometers in their vaccine refrigerators and those that did have calibrated thermometers were unable to produce the certificate.
38 Take Home MessagesImproperly stored vaccines lose their efficacy and will not protect against diseaseExpired vaccines may not protect patientsDo not administer improperly stored or expired vaccinesNotify the Wisconsin Immunization Program if vaccine has been improperly stored or compromised in any way!Take home message,
39 Resources for additional information on vaccine storage and handling Package inserts (can be found at immunize.org)Vaccine manufacturersPink Book – CDC text on VaccinesRed Book – AAP text on vaccinesCDC website:Wisconsin Immunization ProgramJackie Nelson, State VFC Coordinator or
40 Thank You for All You Do to Protect Our Children and Communities For additional information on vaccine preventable diseases, please contact the Wisconsin Immunization Program.Jane Dunbar,Jackie Nelson,