Best Practices: Vaccine Management. October 6, 2016

Transcription

1 Best Practices: Vaccine Management October 6, 2016

2 Overview Vaccine Management Components Cold chain Roles and responsibilities Equipment Monitoring Cold Chain Breaks Resources

3 Key Resources National Vaccine Storage and Handling Guidelines for Immunization Providers, 2015 Public Health Agency of Canada Alberta Vaccine Cold Chain Policy, 2015 FNIHB Alberta Vaccine Management Guidelines 2016 and related tools

4 Cold Chain Basics Definition: The process used to maintain optimal conditions starting at the manufacturer and ending with the administration of the vaccine. Optimum Conditions: Refrigerated vaccines: C Frozen vaccines: minus 15 0 C or lower Where do staff in FN communities fit in? National Vaccine Storage and Handling Guidelines 2015

5 Cold Chain Basics Biologicals will gradually lose potency over time expiry dates! Temperature changes can lead to changes in vaccine potency which are irreversible Successive excursions are cumulative Implications: ineffective vaccines, increased local reactions

6 Cold Chain Basics Heat flows from a warmer substance to a colder substance in proportion to the temperature difference. The greater the difference in the temperatures between two objects, the faster the heat will transfer to the colder object. Application: Vaccine must not have direct contact with frozen ice packs or be directly next to the air vent from freezer.

7 Cold Chain Basics Exposure to Temps 8 0 C + higher Warmer temperatures degrade the vaccine according to mathematical process Impact on vaccine factors: Total time Temperature Number of excursions Type of vaccine (i.e. live virus vs inactivated) Manufacturer Exposure to Temps 0 0 C - lower Results in changes to the shape of molecules in specific vaccines rendering them instantly ineffective inactivated vaccines: always ineffective (temp dependent) live vaccines: no issue if not reconstituted

8 Cold Chain Basics Frozen/Cold packs do not cool off the environment. They absorb heat as they melt. Once melted they will not remove further heat. Application: Frozen/Cold packs must be conditioned for 24 hours before/after use.

9 Cold Chain Basics Air inside the container is not useful. More empty space = greater temperature fluctuations. National Vaccine Storage and Handling Guidelines 2015 Application: Place bottles of water in empty spaces in refrigerator Ensure vaccine bags are full use filler as needed.

10 Cold Chain Basics Temperature external to vaccine is important: Room temperature where vaccine fridge is housed Outside temperature when vaccine is being moved Application: Packing for shipping is different summer/winter Vaccine must always be inside vehicle during transport Vaccine must not be directly in sunshine or near air conditioner/heater vent Vaccine must not be left in vehicle Room temperature should be around 20 0 C

11 Roles and Responsibilities Regional CDC DDC Community

12 Roles and Responsibilities Regional CDC Program standards Vaccine program standards Cold chain management guidelines Ensure vaccine products are available Equipment review and analysis Cold Chain Break assessment and direction re vaccine involved

13 Roles and Responsibilities Drug Distribution Centre Vaccine shipping coordination From manufacturers To end users Supplies Needles, syringes Cold chain products: vaccine bags, gel packs, temp. monitoring tools Cold Chain: Interpret TagAlert codes Trouble shooting relating to transportation issues Guidance re appropriate use of equipment (i.e. Greenbox )

14 Roles and Responsibilities Community Designated individual for vaccine management Ordering Monitoring cold chain Training Clinic staff Knowledgeable about cold chain Use best practices Health Centre Staff: Temperature Monitoring CCB protocol Receiving vaccine Transporting vaccine and supplies Minimize public access to vaccine fridge and supplies

15 Roles and Responsibilities Vaccine Ordering Guidelines Aim to have only enough vaccine for 6 to 8 weeks at any one time Guide to establishing how much to keep in stock: Routine infant and preschool vaccines: calculate using average number of births per year DTaP-IPV-Hib: average number x 4 / 12 MenC: average number x 2 / 12 PCV13: average number x 4 / 12 MMR-Var: average number x 2 / 12 (PSB: may ) ROT: average number x 2 / 12 dtap-ipv: average number / 12 (PSB: may )

16 Roles and Responsibilities Vaccine Ordering Guidelines School program: initial order based on enrollment figures HBV and HPV: order 75% of # grade students for dose 1 and 2 in August for September start; assess format needed i.e. HBV: mixture of 0.5 and 1 ml dtap, MenACYW: order after date set for immunization 85% of # of grade 9s Other vaccines: (not including authorized release only vaccines) FLU: base on average use in previous years PPV23: have some on hand throughout year, with additional doses in conjunction with FLU dtap: stock at least one package Td: assess whether need to keep in stock MMR: suggest one package based on assessed need VZV: suggest one package based on assessed need Polio, Hib: order only when need is identified

17 Roles and Responsibilities Special considerations: Vaccines with diluents packaged separately: Diluent is shipped at same time as antigen Antigen and diluent must always be paired diluents are not generally interchangeable Watch expiry date on diluent (keep shortest dates at the front) Can often be kept at room temperature until needed (check product monograph): if adding to vaccine bag, should be at fridge temperature

18 Health Centre Standards Vaccine fridge: On dedicated electrical circuit Sign near plug: Do Not Unplug Sign near breaker: Vaccine Fridge: do not turn off Only used for biologicals Do not turn off alarm Minimum-maximum thermometer probe in centre of fridge

19 Health Centre Standards Receiving Vaccine Shipments Open green box immediately Check status of TagAlert Complete Vaccine Monitoring Form and fax to DDC Interpreting TagAlert Status: Shows OK vaccine is safe to use Not OK DO NOT USE Quarantine vaccine in fridge, marked DO NOT USE Call Reg CDC Fax CCB Report and Vaccine Monitoring Form Fax Vaccine Monitoring form to DDC, attn DDC Pharmacist

20 Health Centre Standards Receiving Vaccine Shipments Refrigerate vaccine immediately Current stock brought to front Ensure shortest expiry date at front Any CCB vaccine should also be at front Arrange vaccine separately and clearly label Space products to ensure air circulation (5 to 8 cm) Separately packaged diluent does not need to be kept in fridge unless specified by manufacturer

21 Health Centre Standards Cold Chain Breaks Ensure Cold Chain Break Procedure is posted on Fridge Any excursion outside of 2 to 8 0 C is considered a CCB Notify Reg CDC NM or Reg CDC Nurse immediately Complete CCB report and fax to ASAP Label vaccine as being involved in CCB Do not use until direction is received from Reg CDC Follow instructions on CCB report for managing vaccine Discard Okay to use Cold Chain Break Procedure Please post on Immunization Refrigerator Power Outage: 1. Keep door closed. Power Company Contact Information: 2. Determine source of outage. 3. Check with power company If power will be out for less than one hour do nothing. If power will be out for longer than one hour Place vaccine in alternative storage Properly packed coolers Properly packed insulated bags Another monitored refrigerator (if more than 4 hours) 4. Complete Cold Chain Break Form 5. Notify Regional CDC Nurse Manager; Nursing Supervisor Vaccine left out of Refrigerator: 1. Label vaccine: Do Not Use 2. Refrigerate vaccine 3. Complete Cold Chain Break Form 4. Notify Regional CDC Nurse Manager; Nursing Supervisor Refrigerator Failure: 1. Label vaccine: Do Not Use 2. Complete Cold Chain Break Form 3. Notify Regional CDC Nurse Manager; Nursing Supervisor. Contact Numbers: Nursing Supervisor: Regional CDC Nurse Manager: Ruth Richardson: Cell: Fax: Brent Whittal: Cell: After Hours:

22 Health Centre Standards Clinic Practice Guidelines Fridge door should only be opened max 4 x /day Use vaccine bags for clinics to help achieve this target Nurse who packed vaccine bag is responsible for returning vaccine to fridge at end of clinic» Only take minimum required out of fridge Use TagAlerts whenever vaccine is out of fridge Minimize the number of packages that are open Define process to visually alert all users to opened pkgs New expiry date for opened multi-dose vials Use opened vials/packages before opening new pkg

23 Health Centre Standards Clinic Practice Guidelines Dating MDV: New expiry date as per specific vaccine indications on vial and box Date opened + allowable time = new expiry date, e.g.: Oct 6, days = Nov 3, 2016» Fluzone MDV: must discard after 28 days*» PPD: must discard after 28 days» BCG: must discard after 8 hours» Hep B: not considered a MDV see school specific guidance on Vaccine Summary Page

24 Health Centre Standards Clinic Practice Guidelines Handle all vaccines in accordance with manufacturer s guidelines: Administration: route, dosage Handling: Exposure to light Keep vaccine in original packaging. Time for administration once reconstituted All vaccine wastage to be recorded on Vaccine Wastage Report Submit to Reg CDC monthly

25 Health Centre Standards Ensure use current resources: All vaccine management resources have been updated in New: Maintenance Record Vaccine Storage and Handling Checklist

26 Equipment Green Boxes Refrigerators Vaccine Bags Thermometers TagAlert Gel packs Filler

27 Equipment GreenBox How to Use For vaccine shipments from DDC Designed to maintain temperature for 72 hours Do NOT use knives to open container to avoid damage Return GreenBox to DDC using return shipping labels promptly Pack box exactly as received: Place plates around empty inner box (top, bottom, sides) so that there is no movement

28 Equipment Laboratory Fridge Variety of models Target temp: 5 0 C Benefits: Temperature regulation Defrost mechanism Spatial temperature differential Cautions: Poor insulation Exposure to light Source: Suhas Thalesvar, DDC Pharmacist 2008 National Vaccine Storage and Handling Guidelines 2015

29 Equipment Vaccine Bags Standard: Vaccine Bags are to be used whenever vaccine is away from fridge. Replace every 2 years or when damaged Ensure packed properly to maintain 2 to 8 0 C Less than 4 hours: cold pack okay More than 4 hours: add frozen pack(s) Monitor temperature Cold pack TagAlert Vaccines Cold Pack Filler Frozen Pack

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31 Equipment How to Use: Place probe with glycol in middle of fridge Ensure clear space around it Read temperature at least 2 times each day Current Low High Reset after each reading Ensure alarm is in on position Document readings Change battery and check cable at least once a year Min-Max Thermometer

32 Equipment TagAlert Available from DDC How to Use Use whenever vaccine is away from fridge Once activated, will monitor for up to 10 days: mark date and time activated Use a new unit each time Place immediately next to vaccine If anything other than OK shows, contact Reg CDC or Regional Pharmacist at DDC

33 Equipment Gel Packs Frozen: Packs are Not interchangeable Cold: Best Practices for use: Keep in dedicated biological fridge/freezer Condition for 24 hours before each use Replace if damaged or very dirty Cold packs: completely line container on all 6 sides Frozen Packs: use top and/or bottom if appropriate Filler/buffer: place between cold pack and vaccine

34 Equipment Buffer and Filler Purpose is to protect vaccine from temperature extremes and minimize empty air space Place at potential contact points between Gel packs and vaccine Fill empty spaces to stabilize vaccine position; minimize dead air Examples include: professional towels, paper towels, crumpled paper, bubble wrap caution if using blue pads: may be too warm

35 Equipment Process for packing a bag or cooler; pictures courtesy of DDC

36 Equipment Emergency vaccine storage In event of power outage, need to have capacity to maintain cold chain for vaccine inventory Known short outages (less than 4 hours): Move vaccine from fridge into bags/coolers for duration Unknown duration or outages more than 4 hours: Contact service provider to get estimate Move vaccine from fridge to a back-up fridge off-site Ensure sufficient, appropriate storage containers Ensure sufficient gel packs Identify back-up off-site location with monitored fridge (write down process just in case!)

37 Equipment Note on coolers: Need to check coolers and test them to see how long they maintain temperature not all coolers are equivalent. Things to look for: Locking lid At least 1 ½ to 2 inches insulation

38 Equipment Maintenance Refrigerator: Clean motor and coils 2 to 3 times per year Check door seals 2 to 3 times per year Clean interior and surfaces at least annually or as dirty Min-max thermometer: Change battery at least annually (Jan 2?, Sept 1?) Check probe cable integrity at least 3 times per year Ensure probe in proper position at least weekly Maintain documentation of these activities

39 Monitoring Daily: monitor minimum, maximum and current temperature Twice: first thing in morning and last thing in afternoon Monitor room temperature Document readings on Temperature Monitoring Form Designate a person who is in the HC each day Back-up person for when designated person is away

40 Documentation All documentation should be kept in the community for at least 5 years: Temperature monitoring forms Maintenance records

41 Cold Chain Breaks CCB: Any excursion outside of the 2 to 8 0 C range Ensure CCB Procedure is posted on fridge Complete CCB Report Form and submit to Regional CDC 2 hours to 8 0 C Source: Suhas Thalesvar, DDC Pharmacist 2008

42 Resources FNIHB: Vaccine Management, Inoculist Background information PHAC: National Vaccine Storage and Handling Guidelines for Immunization Providers 2015 Alberta Health: Vaccine Cold Chain Policy, 2015 Alberta Health Services: Vaccine Storage and Handling web-page

43 Test Your Knowledge

44 Question 1 The phrase cold chain refers to how vaccine is managed from manufacturing to administration. True False

45 Question 2 Equipment used to maintain the cold chain includes all of the following except: Purpose built fridge Vaccine bag Picnic coolers Solid storage bins Min-Max Thermometer Blue pads Bubble wrap Frozen Gel Packs Cold Gel Packs TagAlert

46 Question 3 Temperature of the fridge only needs to be monitored when there is a nurse in the building. True False

47 Question 4 Temperature and maintenance logs need to be retained for: a. 2 years b. 5 years c. 3 years d. Life of refrigerator

48 Question 5 Appropriate uses of TagAlerts for monitoring temperature are: Include in Greenbox with vaccine shipment Delay reading Tagalert until vaccine is unpacked Include whenever vaccine bags are used Good for 10 days once activated as long as shows OK Place in middle of vaccine packages

49 Question 6 When organizing vaccine fridge, which of the following is incorrect? All opened vaccine packages can be kept in one bin Bins for vaccine need to be labelled with contents Bins should be mesh vs solid Short-dated product and product with CCB exposure should be at front of bin Empty space should be filled with bottles of water and/or cold packs Vaccine bags can be kept in the fridge over lunch break on clinic days

50 Question 7 Which of the following products should not be kept in the biological fridge? Snacks and juices, staff lunches Insulin Specimen containers Diluent for vaccine Vitamin B12

51 Question 8 When should the plan to move vaccine to the back-up monitored site be considered in the event of a power outage? Immediately. After contacting service provider and finding out outage will be at least 4 hours. If notice received that power will be out for 1 hour for routine maintenance.

52 Question 9 The following options can be considered for back-up monitored sites: Your fridge at home Fridge at local pharmacy Biological fridge in neighbouring community

53 Question 10 What is an appropriate amount of DTaP-IPV-Hib to keep in stock with an average of 40 babies a year? (5 doses per package) 3 packages 5 packages 1 package 8 packages

54 Question 11 Indicate True or False for the following scenarios: a. Vaccine involved in a 3 rd CCB must be immediately discarded. b. A vaccine bag with vaccine has been left on the counter over the W/E: everything must be immediately discarded. c. While doing school HBV, only 0.5 ml of 1.0 ml vial was used. The remaining 0.5 ml can be used the next day.

55 Question 12 While the best practice is to use reconstituted vaccine immediately (i.e. within ½ hour of reconstitution), if cold chain is maintained, what guidance should be used for vaccines where the manufacturer states product is good for at least 8 hours? a. Discard at end of clinic/day if not used. b. Keep in open bin in fridge so other staff will know it has been reconstituted to avoid waste. c. Mark date/time reconstituted on package and vial, keep at front of bin so other staff will know it has been reconstituted to avoid waste. d. If reconstituted vaccine is found in fridge at the start of the clinic day, it should be used first.