Sr. Field Services Representative (Bay Area Region)

Transcription

1 Vaccine Storage & Handling For the Vaccines for Children Program Steve VanTine, BS Steve VanTine, BS Sr. Field Services Representative (Bay Area Region)

2 VFC Provider Enrollment Any qualifying practitioner authorized to administer pediatric vaccines under CA state law and interested in providing routine childhood vaccines through the program is eligible to enroll with the CA VFC Program. The administrative requirements to enroll include: Agreement to follow all federal participation requirements outlined in the Provider Enrollment Agreement and Capacity to Store Vaccines Providing estimates of patients to be immunized with VFC-supplied vaccines (Provider Profile form), listings of all providers with prescription privileges in the practice, and vaccine delivery information Having a vaccine storage unit and thermometers meeting program requirements Successfully completing an initial site visit

3 Why Train for Storage & Handling? Compromise efficacy of the vaccine Possible injury to patients Affect consumer confidence in vaccinations Cost factor: VACCINES ARE EXPENSIVE!

4 "Storage Errors Cause Thousands to Be Vaccinated Again Associated Press (01/21/05) Almost 3,900 people in Tennessee's Jefferson and Fayette counties must receive new vaccinations against influenza, hepatitis B, polio, pertussis, diphtheria, tetanus, and pneumonia after storage errors resulted in ineffective vaccines. East Tennessee regional director for the state Department of Health Dr. Paul Erwin says that the vaccinations were stored below freezing for a period of time when they were not supposed to be stored that way. Erwin notes that the ineffective vaccines are not dangerous, and patients requiring new vaccinations are being notified via certified mail... Total cost of replacing compromised vaccine, revaccination, patient recall, supplies and staff time estimated to be in excess of $900,000.00!

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6 803 vaccine doses 15cu ft. refrigerator $32,000. worth of vaccine

7 Required Vaccine Storage Temperatures Refrigerator F (2-8 C) Freezer Varicella, MMR, MMRV, Zostavax + 5 F (-15 C) or colder 32 F. is freezing

8 Effect of temperature on vaccines Inactivated vaccines and toxoids Too cold (freezing 32 F. or below) Adjuvanted Adjuvants enhance immune response to an antigen. Antigen and adjuvant bond is immediately and irreversibly broken; adjuvant effect is lost. HepA HepB diphtheria-tetanus-pertussis (DTaP, Tdap) Haemophilus influenzae type b (Hib) human papillomavirus (HPV) Pneumococcal Non-adjuvanted- denaturing protein, structural damage

9 Effect of temperature on vaccines Inactivated vaccines and toxoids Too warm (above 35-46ºF) Damage is gradual Very stable compounds. All inactivated vaccines can tolerate room temperature (~77ºF.) for ~ 72 hours

10 Effect of temperature on vaccines Live vaccines Store at Freezing 5 F. or below Lyophilized is freeze dried -undiluted, anylyophilized vaccines cannot be damaged by freezing (including inactivated Caution: DO NOT FREEZE DILUENT

11 Effect of temperature on vaccines Live vaccines Too warm ( above 5ºF.) Damage is rapid or quick Varicella does not tolerate any heat MMRalso heat sensitive (store between - 58 F to 46 F). Although stable in either the refrigerator or freezer, we recommended to store in freezer.

12 Best practices for vaccine storage Store only vaccine in vaccine storage units. Separate the VFC vaccine supply from privately purchased vaccine. Keep vaccines in their original boxes until you are ready to use them. Some vaccines are sensitive to UV light (i.e. HPV, MMR, MMRV, rotavirus, varicella, and zoster vaccines) Group vaccines by pediatric, adolescent, and adult types. Place vaccine in breathable plastic mesh baskets and clearly label baskets by type of vaccine. Keep baskets 2-3 inches from walls and other baskets. Keep vaccines with shorter expiration dates to front of shelf. Transfer short-dated vaccine If you have vaccine that will expire in 4 months or less, contact other VFC Providers to see if they can use the vaccine prior to the expiration date. Keep refrigerator temperatures between 35ºF to 46ºF. Aim for 40º F Keep freezer temperatures at 5ºF or below.

13 Solution Refrigerator-only units Purpose- built vaccine refrigerator Australia US domestic grade $ Sears

14 REFRIGERATOR RECOMMENDATIONS 1 door, rubber sealed, with temperature controls. Large enough to hold largest quantity of vaccine on hand AT ANY GIVEN TIME Frost Free No manual defrost FF has a heating element to evaporate frost

15 Refrigerator notes Work with your VFC rep/field rep to determine optimum size Leave a 1 2 space around the sides of the fridge to allow for air flow Set temperature to range between Fahrenheit Do NOT over fill your fridge with vaccine Refer to the ezizwebsite for online training

16 Not Recommended Dorm Style refrigerators: Large or small Cooled by the freezer unit Cooling radiates outward from freezer unit cannot store vaccines close to freezer on top shelf No longer recommended for storing vaccine for any length of time... For any reason!

17 Not Recommended

18 Refrigerator Notes Plug into outlet that is on it s own circuit. Never plug into outlet controlled by wall switch. Use VFC-provided Do Not Unplug Signs. Bottles of water to line the door of the fridge. Do not use vegetable bins-warmer. No food in the vaccine refrigerator. No vaccine in doors, along walls, under vent. No lab specimens in the fridge.

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20 What NOTto do No vaccine in doors, along walls No vaccine in solid plastic trays or containers. No food or lab specimens in refrigerator. No vaccine in drawers or on floor of refrigerator. Never plug into outlet controlled by wall switch. Do not ignore out of range temperatures

21 VACCINES ARE VERY EXPENSIVE

22 What s wrong with this picture?

23 What s wrong with this picture? Dormitory-style unit Ice in freezer unit Too much vaccine for size Soda in the door Lab specimen in the fridge Vaccine on top shelf probably frozen

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27 Temperature Monitoring VFC Program requires temperatures be monitored at twice (2 times) each day Temperatures must be recorded on VFC-approved temperature logs All temperature excursions MUSTbe reported immediately (to ensure the efficacy of the vaccine).

28 Clinic refrigerator repeatedly dropped below freezing over a 17-month period in 2005 and 2006 Both of these providers documented similar out of range temperatures for at least 6 months

29 New Separate Temp Logs

30 Thermometer Recommendations CDC Certified/Calibrated by NIST, ASTM, or other appropriate agency. Certified in accordance with NIST or ASTM standards : A certificate of calibration shows that your thermometer has undergone additional testing to ensure accuracy. Personal preference: Measure temperature of liquid/ or measure ambient air temperature.

31 Types of Thermometers 1. Thermometers that measure air. Probe hanging in air. 2. Thermometers that measure liquid Probe is immersed in a glycol solution. 3. Infrared thermometers and computerized thermometers. 4. Continuous recording: Gives the ability to review and store all past temperatures (on a paper wheel or electronically) for future reference. Graphs temperature over time. Do not confuse a high/low recording thermometer with a continuous-tracking thermometer. High/low units only offer basic information about the warmest and coldest temperature a thermometer has reached. DO NOT RELY ON PAPER WHEEL OR ELECTRONIC RECORDS TO DOCUMENT VACCINE TEMPERATURES. It is a VFC Requirement to use the VFC Approved Temperature Logs to physically monitor and record temperatures twice a day.

32 Thermometer Digital Certified/Calibrated

33 Continuous Recording

34 NOT CERTIFIED/CALIBRATED

35 NOT CERTIFIED/CALIBRATED

36 NOT CERTIFIED/CALIBRATED

37 NOT CERTIFIED/CALIBRATED

38 Temperatures can vary within the same unit O 37.4 F F F F F Place thermometer or thermometer probe towards center of the unit

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40 Temperature is Out of Range Freezeris too Warm 1. The freezer Temp is above +5 F Call your Field Rep or VFC Rep. They may refer this problem to Merck, ( ) for resolution. Have specific information available, i.e.. lot number, date received, temperatures, how long temperature out of range, etc.

41 Temperature is Out of Range RefrigeratorToo Cold or Too Warm Temperature is F: Adjust the refrigerator temperature control to recommended range (recommended temp: 40 F) Monitor temperatures every hour to determine if the problem is correcting itself. Temperature is 32 For colder, or 47 Fand warmer: Contact your Field Services Rep or VFC Rep IMMEDIATELY (the Immunization Branch has established protocols for these situations)!

42 Refrigerator Temperatures Inactivated vaccines are more tolerant of warmer temperatures Cold temperatures FREEZE vaccines When temperatures are out of range: contact your VFC/Field Services Rep NEVER remove vaccines from the refrigerator when there is a question as to the efficacy of the vaccine!

43 Storage and Handling Problem Protocol Notify your facility manger Contact your Field or VFC Rep and discuss the problem. Contact the manufacturer when told to do so by VFC staff. The VFC Central office staff will complete a Vaccine Storage and Handling Problem Report. Do NOT use the vaccine until its efficacy has been determined.

44 Questionable Vaccine Viability Do NOT allow clinic staff to use vaccine until efficacy is determined. Label vaccine as Do Not Use Wait for resolution before taking any action. Do not discard vaccines leave in refrigerator or freezer. Any spoiled or expired vaccine needs to be returned to the VFC Program

45 Return any nonviable VFC Vaccines 1. Contact the VFC Program office at (877) 2GET-VFC or (877) each time you need to return or transfer vaccines. Request a vaccine return label. 2. Complete the VFC Program s Return or Transfer of VFC Vaccines Reportform (download on 3. Fax or mail a copy of the transfer form to the VFC office at: Fax: (877) FAXX-VFC Vaccines For Children Program State of California Department of Health Services Immunization Branch 850 Marina Bay Parkway Building P, 2 nd Floor, Room 2362 Richmond, CA Place another copy of the form in the package that you will return the expired or spoiled vaccine in and mail to: McKesson Specialty Distribution Center 3400 Fraser Street, Aurora, CO Attn: Randy Mohring NOTE: Vaccines do not need to be shipped in cold storage since they are no longer usable.

46 EZIZ Lessons: Administering, Storing and Monitoring Vaccines! Have you completed these lessons?

47 Steven J. Vantine, BS Sr. Field Services Representative Phone: (510) Fax: (510)

48 Questions?