Introduction: A supply and logistics guide for the switch

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What is the purpose and intended audience of this document?
This document is intended to help national planners convey simple, straightforward guidelines for EPI
logisticians to apply when preparing and carrying out all Switch-related logistical activities. It is organized by
level of the cold chain, in order for each individual to quickly identify the responsibilities most relevant to him
or her. This includes:
 National cold chain logisticians
 Regional cold chain logisticians
 District cold chain logisticians
 Health facility staff
What is my role in shaping this document?
Before sharing this document with EPI logisticians throughout the cold chain, customize it to your country
context, and to reflect the specific Switch-related decisions you will have to make to execute the Switch.
These decisions may include the following factors, as illustrated in Table 1.
Table 1. Key decisions and actions for the National Planner prior to customizing this document
Key Decision
Exact timing for Switch Day / Switch
Schedule
Factors to Consider
 Sync with existing processes where possible: Take into account
routine delivery schedule from district to health facility level to
minimize resources needed for distribution.
 Consider week-ends for distribution of bOPV and withdrawal
of tOPV when there are no immunization activities, minimizing
the likelihood of misuse of tOPV or disruption of services.
Choice of Switch Mechanism at lower
 Normal method of vaccine ordering and distribution in your
levels
country
 “Push” Exchange: District delivers bOPV  Risk/ benefit analysis of each option (see page 16 of this guide)
to facilities and picks up tOPV
 Funding and reliable transportation available to enable Districts
 “Pull” Exchange: Facilities collect bOPV
to deliver to Health Facilities within tight timeline/funding
from district and surrender tOPV
mechanism and/or transport to ensure Health Facility staff
 Preposition: Deliver bOPV to Health
come to exchange tOPV for bOPV within tight timeline
facilities just before Switch day

Please note: during Switch pilots, several locations
preferred the “Push” Exchange Scenario to ensure
success and validation of the Switch.
tOPV Collection Plan and Disposal
Method1
In order of optimality, the preferred
disposal methods are:
1. Co-incineration (suitable for both rural
and urban areas): ensure combustion at
between 900 and 1200°C in hospital or
industrial-sized incinerator
2. Encapsulation (suitable for rural areas




Likely volume of tOPV that will need to be disposed of (see the
tOPV Disposal Volume Calculator for guidelines on how to
calculate this)
Existing national regulations around disposal at different levels
Whether disposal will be conducted at national or
provincial/regional level (recommended) versus at district or
facility level (in which case, monitoring should be conducted)
Availability, location, and quality of disposal facilities at each
level and for each type of area (rural or urban)
For vaccine manufacturing countries, returning unused stocks to manufacturer would be ideal; however, this is unlikely
to be feasible for more than a handful of countries. For more details on waste disposal methods, refer to Safe management
of wastages from health-care activities, WHO 2013
1
i
NATIONAL PLANNERS ONLY
Preface for National Planners: How to use this document


Suitability of disposal sites:
o Availability of technically qualified staff
o Accessibility of disposal site after Switch Day
o Current readiness or ease of preparing the site
o Good management and cleanliness of site
Funding and staff availability for disposal monitoring
mechanism (recommended though not required)
For more guidance on how to develop a waste disposal plan for the
Switch, see page 8 of this guide

Funding available for unplanned, emergency dispatch of
antigens
Given that several of these decisions will have financial implications, national planners are recommended to:
 Advocate early for sufficient funds from national and partner sources to finance relevant Switch
activities, based on a comprehensive, costed national Switch plan
 Design processes which are realistic in light of expected funding
 Ensure the secured funds efficiently flow down and are received on time at the level at which they are
required (e.g. sufficient transportation funds are required at district level for a “push exchange”, and at
health facility for a “pull exchange” scenario.)
How should I best adapt this document for use in my country?
You should adapt this document to retain only the information that is relevant to your country-specific
situation and the Switch mechanisms you choose. In order to do this:
 Replace [text in orange brackets] throughout the guide with the appropriate information for your country.
This includes, for instance, the exact date of the Switch.
 Identify which distribution/disposal scenario [in purple text] applies to your country
o Retain the relevant paragraphs which apply to your country situation
o Delete the scenarios that do not apply to your country situation
 Omit this preface (pages i and ii) and share only the adapted guidance with all EPI logisticians at the
applicable level.
ii
NATIONAL PLANNERS ONLY
only): Place the vials in hard containers,
such as metal drums, and add an
immobilizing material, such as cement,
bituminous sand or clay. When dry, the
drum or container can be sealed and
buried in local landfill or a pit in a healthcare facility
3. Sanitary landfill (suitable for rural areas
only): Dispose in fenced off sanitary
landfill with no recycling activities nor
public access
Contingency Planning
Managing the Switch
Supply and logistics guide for the switch
1
Contents
Introduction: A supply and logistics guide for the switch .......................................................... 3
1.
2.
3.
4.
What is “the Switch”? ..................................................................................................................................................... 3
What are the logistics implications of the Switch?.............................................................................................. 3
What is the purpose of this document? ................................................................................................................... 3
Overview of the Switch ................................................................................................................................................... 4
Common Principles for All Levels ............................................................................................. 5
1.
2.
3.
4.
5.
6.
tOPV inventories: conduct two inventories at all levels ................................................................................... 5
Calculating tOPV supply requirements until the Switch .................................................................................. 5
Communicating the Switch schedule and plan to lower levels ...................................................................... 6
Distributing bOPV to the next level down .............................................................................................................. 6
Contingency planning and tOPV buffer stock for emergency deliveries ................................................... 6
Disposal of excess tOPV after the Switch ................................................................................................................ 6
Central Vaccine Store ............................................................................................................ 10
1. Conduct inventories at Central Vaccine Store and coordinate inventories at lower levels ............. 10
2. Review and adjust procurement plans based on tOPV inventories ........................................................... 10
3. Communicate the Switch schedule and plan to lower levels ........................................................................ 11
4. Distribute last shipment of tOPV and first shipment of bOPV to lower levels, and organize incountry redistribution as required ................................................................................................................................... 11
5. Coordinate contingency plan and maintain buffer stock for emergency deliveries ........................... 11
6. Dispose of excess tOPV after the Switch................................................................................................................ 12
Regional Vaccine Store .......................................................................................................... 13
1. Conduct inventories at Regional Vaccine Store and coordinate inventory at District Level ........... 13
2. Distribute last shipment of tOPV and first shipment of bOPV to District level, and organize
redistribution within region if required ......................................................................................................................... 13
3. Execute Contingency Plan ........................................................................................................................................... 14
4. Dispose of excess tOPV after the Switch................................................................................................................ 14
District Vaccine Store............................................................................................................. 15
1.
2.
3.
4.
5.
6.
Conduct inventories at District Vaccine Store .................................................................................................... 15
Receive and properly store tOPV and bOPV in preparation for the Switch ........................................... 15
Establish contingency plan (and maintain a buffer stock for emergency deliveries) ........................ 15
Distribute last shipment of tOPV, and organize redistribution within district if required .............. 16
Implement Switch: first shipment of bOPV to health facilities, collection of tOPV.............................. 16
Dispose of excess tOPV after the Switch................................................................................................................ 18
Health Facility Level ............................................................................................................... 19
1.
2.
3.
Communicate any unplanned tOPV needs through contingency mechanism ....................................... 19
Execute the Switch ......................................................................................................................................................... 19
Dispose of excess tOPV after the Switch................................................................................................................ 20
Annex 1: Labelling of tOPV bags/containers for disposal ....................................................... 21
Annex 2: Sample tOPV collection form .................................................................................. 22
2
1. What is “the Switch”?
Eradicating polio requires a globally coordinated effort to shift from the use of Oral Polio Vaccine (OPV) to
Inactivated Polio Vaccine (IPV) through a phased approach.
1. All countries must introduce in 2015 at least one dose of IPV into routine immunization systems as a
complement to the OPV schedule.
2. All countries switch from using trivalent OPV (tOPV) to bivalent OPV (bOPV) for routine
immunization and campaign immunization activities. This will drastically reduce occurrences of
Vaccine Associated Paralytic Poliomyelitis (VAPP) and Circulating Vaccine-Derived Poliovirus
(cVDPV).
3. Finally, after global certification of polio eradication, there will be a need for the global cessation of
OPV usage, leaving IPV as the sole polio vaccine used in routine immunization.
This document centers on the second step of polio eradication: the replacement of tOPV with bOPV (“the
Switch”), which will occur in April 2016 across the world. Shortly before this date, all manufacturers will stop
producing or distributing tOPV. As of the date of the Switch, no child should be vaccinated with tOPV.
The Switch must be a globally coordinated process; ongoing tOPV use after April 2016 would hinder polio
eradication due to possible outbreaks of cVDPVs.
An overview of the Switch activities is presented on the next page.
2. What are the logistics implications of the Switch?
tOPV and bOPV require the same number of doses for full immunization, and have the same administration
process and schedule. Thus, the impact of the Switch on vaccine service delivery will be limited.
However, the Switch differs from a traditional vaccine replacement process, because tOPV usage must stop on
the same day throughout the country, and all unused tOPV must be disposed of as soon as possible thereafter.
Thus, the Switch presents unique challenges for supply chain and logistics systems both in country and
globally, such as:
 Careful forecasting of tOPV stock to minimize wastage yet avoid stock outs prior to the Switch
 The short-term complexity in the cold chain logistics system as both bOPV and tOPV will be stored in
the system for a period of time leading up to Switch Day
 The need for contingency distribution plans in case of stock outs or polio outbreak before the Switch
 Disposal of all tOPV as soon as possible after the Switch Day, but no later than three months after the
Switch Day.
Stock management practices for the Switch should, as much as possible,
build on existing routine supply and cold chain processes in country.
3. What is the purpose of this document?
This document provides guidelines for EPI logisticians to apply when preparing and carrying out all Switchrelated logistical activities. It is organized by level of the vaccine supply chain, in order for each individual to
3
RELEVANT FOR ALL LEVELS
Introduction: A supply and logistics guide for the switch
The guidelines here presented were developed at global level, in order to facilitate a coordinated Switch across
countries, and have been adapted by national planners to fit the [country] context.
4. Overview of the Switch
The table below summarizes the key activities of the Switch. Logistics-related activities for which guidance is
provided in this document are bolded.
By June 2015
Plan
- Establish management structure
- Establish National Switch Validation Committee (NSVC)
- Conduct situation analysis
- Draft national switch plan (budgeted and finalized by Sept 2015)
May to September 2015
- Complete detailed tOPV inventory; adjust tOPV delivery (may vary per country)
- Secure funding and finalize national switch plan
- Develop monitoring plan
October to November 2015
Prepare
- Complete second tOPV inventory; adjust tOPV orders and/or delivery
- Order bOPV
- Develop waste management protocol
- Hire switch support staff
December 2015 to January 2016
- Receive last tOPV delivery to country;
- Redistribute remaining tOPV stock within country as required
- Prepare training materials and implement communications strategy
- Begin bOPV deliveries to countries
February to March 2016
- Deliver last 1-2 months of tOPV to periphery; redistribute as needed
- Identify switch monitors
Implement
National
Switch Day
Validate
Two to four weeks prior to the switch
- Train switch monitors
- Train health workers
- Distribute bOPV to periphery and service points
A day chosen during the period of 17 April to 1 May, 2016
- Stop use of tOPV and remove tOPV from cold chain
- Begin use of bOPV
In a two week period after the Switch Day
- Validate tOPV disposal at selected sites (switch monitors)
- Collect and review data and validate switch (NSVC)
4
RELEVANT FOR ALL LEVELS
quickly identify the information most relevant to him/her, and can serve as a stand-alone, comprehensive, user
friendly checklist for each level.
The main principles underpinning this guidance are:
 Stock management practices for the Switch should, as much as possible, build on existing routine supply
and cold chain processes in country
 There is a “right balance” which must be found between the two imperatives of the Switch:
A table summarizing key logistics considerations relevant for all levels is found on page 8.
1. tOPV inventories: conduct two inventories at all levels
To help minimize tOPV wastage, two national inventories of tOPV should be conducted in the year leading up
to the tOPV/bOPV Switch. The inventory data will help to inform stock procurement and distribution in the
lead-up to the switch.
The first inventory
To be completed as soon as possible, before end of
September 2015

Data to be used to adjust quantity and timing of
shipments of tOPV in the remaining months
before the Switch day to avoid upfront risk of
over-stocking.
The second inventory
To be conducted approximately 6 months before
the Switch (~ October /November 2015), prior to
the final tOPV shipment

Data to more precisely inform the final order,
enable in-country redistribution, and minimize
overall wastage.
While many countries already have stock management tools in place, due to the level of precision required for
forecasting for the Switch, physical counts of tOPV will be necessary. The IPV OPV inventory tool 2
developed by UNICEF can be used to support this process.
2. Calculating tOPV supply requirements until the Switch
To calculate quantities for the last shipments of tOPV to each level, follow the consumption-based formula:
tOPV used over a given period =stock at beginning of period + received stock – current stock
If consumption-based method is not possible, or for areas with reliable target populations:
Amount of tOPV to distribute to the next level down =
((Annual target population × number of doses needed per child × Wastage factor) × (number of days
of stock to be delivered/365)) - (tOPV stock remaining as reflected in the inventory)

As the Switch day draws closer, supplies should be calculated based on immunization activities planned
and previous consumption, and not just based on target beneficiaries. In preparation, it is important to
strengthen mechanisms to review vaccine utilization (and not just distribution), needs assessment and stock
management. This could entail for instance, a periodic review meeting of regional district and health facility
level vaccine handlers.
2
Available at:
http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/oral_polio_vaccine/implementation/en/
5
RELEVANT FOR ALL LEVELS
Common Principles for All Levels
Countries are encouraged to perform an analysis of their actual consumption compared with target
consumption by region after the inventory, and adjust their average consumption and minimum/maximum
levels for Regions, Districts and Health Facilities as required.
3. Communicating the Switch schedule and plan to lower levels


Staff should use stock distributions taking place over the months leading up to the Switch as an
opportunity to remind vaccine store staff at the lower levels of the upcoming timelines and responsibilities.
Communication on the distribution plan, contingency plan and contacts (see #5) and the tOPV collection
and disposal plan (see #6) should be included as well.
4. Distributing bOPV to the next level down
bOPV should be distributed early enough to arrive at the district level at least two weeks before the Switch.
Work backwards from this timeline while developing a distribution plan to ensure bOPV arrives in time for
distribution at each level.
Amount of bOPV to distribute to the next level down = (Annual target population × number of doses
needed per person × Wastage factor) × (number of days of stock to be delivered/365)
The consumption-based forecasting method described above can be used where appropriate.
5. Contingency planning and tOPV buffer stock for emergency deliveries
Supply disruptions may arise from inaccurate forecasting or higher than expected demand or wastage.
Contingency plans should be developed to ensure stock outs of tOPV don’t result in children missing out on
vaccinations in the lead up to the Switch.
 One week buffer supply of tOPV should be kept at Central level, ready for distribution for any
new/unscheduled delivery
o EPI should decide whether any extra stock of tOPV should also sit at the Regional level or if the risk
of localized stock outs can be minimized through reallocation of routine stock across health facilities.
 Focal points should be designated at national, regional, district levels to field emergency requests for
additional supply of tOPV
 Ensure all levels are aware of the procedures and know who to contact in the event of higher than planned
use, unusually large demand (e.g. polio outbreak leading to new campaign needs) or unexpectedly large
wastage (e.g. temperature excursion).
A contingency plan should also be in place in case distribution plans must be adjusted due to delays in delivery
of bOPV at any level. This may require a parallel distribution, which may require additional logistics.
6. Disposal of excess tOPV after the Switch
On Switch day, all remaining tOPV must be removed from the cold chain at all levels and, after the Switch,
tOPV must be rapidly disposed of in order to reduce the risk of cVDPV.3 National planners should develop,
communicate, and execute a tOPV collection and disposal plan for the country.
 The national team may choose to involve the regional and/or district level in the creation of the collection
and disposal plan.
“The rate of poliovirus inactivation is dependent on numerous conditions, but survival in the environment is finite. Interpolation of
the available data indicates that poliovirus infectivity decreases by 90% in soil every 20 days in winter and every 1.5 days in summer, in
sewage every 26 days at 23°C, in fresh water every 5.5 days at ambient temperatures, and in seawater every 2.5 days under the same
conditions. ” The Biologic Principles of Poliovirus Eradication, Walter R~ Dowdle and Maureen E. Birmingham, JID
1997;175(suppl1):S286-92
3
6
RELEVANTVACCINE
CENTRAL
FOR ALL LEVELS
STORE STAFF

Acceptable disposal methods and facilities required (from most to least optimal):
Co-incineration
Encapsulation
Functional incinerator sites that
are large enough (i.e. hospital or
industrial sized) and able to treat
health care waste by operating at
temperatures between 900 and
1200°C4
Preferred for rural and urban areas
Available landfills or pits where
hard containers (such as metal
drums) in which vials have been
encased in immobilizing materials
(e.g. cement, bituminous sand, or
clay) can be disposed of safely.
For rural areas only
Protected Sanitary Landfill
disposal
Accessible landfill sites that are
fenced off and inaccessible to the
public and free of visible illegal
recycling activities
For rural areas only
Create a national tOPV collection and disposal plan.
 Estimate the quantity of tOPV that must be disposed of nationally and in each region, remembering that 1
week of tOPV supply for one million inhabitants is roughly 5-8 liters for disposal.
o If tOPV deliveries are carefully monitored in the months prior to the Switch Day, most countries
should have a minimum of a few days and a maximum of two weeks of remaining tOPV in stock at
each service point, i.e. 10-16 liters per population of one million.
o This remaining tOPV should be disposed within three months after Switch Day.
Estimating tOPV disposal volume.
For regions applying the multi-dose vial policy (MDVP):
Total litres of tOPV for disposal = 0.005 x wks of tOPV supply to dispose x target population/1000
For regions not applying the MDVP:
Total litres of tOPV for disposal = 0.0075 x wks of tOPV supply to dispose x target population/1000
Assumptions: Based on 3.5% newborns, 4 dose EPI calendar, 85% coverage, 30% wastage and 1.5 cc volume per dose including
packaging, disposal volume is 0.005 L per 000' population for regions applying the MDVP, 0.0075 L per '000 for others not applying the
MDVP.



Map and assess the disposal facilities available at each level and each geographical area.
After consultation with subnational levels as appropriate, select disposal sites based on the following
criteria:
o Availability of technically qualified staff
o Accessibility of disposal site after Switch Day
o Current readiness or ease of preparing the site
o Good management and cleanliness of site
Specify in the plan who will transport the tOPV from which stores and on what date based on optimal
disposal method and feasibility.
Communicate disposal plan to [relevant subnational] levels.
 Coordinate with lower subnational levels to check all potential disposal sites for readiness and adjust
disposal plan if required
 Ensure that all selected disposal sites are informed about their task and implement necessary preparations
 Ensure all health facilities, including private, with tOPV receive a copy of the collection and disposal plan
Small (i.e. with a capacity of one or two chambers) incinerators are not recommended, because of the risk of exploding vials. For
further reading see: Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies, WHO 1999 and Safe management of wastages
from healthcare activities, WHO 2013
4
7
RELEVANT FOR ALL LEVELS
Disposal of tOPV after the switch should follow national waste management legislation. If national
legislation does not provide clear guidance, the following methods, in order of priority, are considered safe.
Summary of key logistics considerations relevant for all levels
Topic
Inventory
OPV procurement
Key Points
Conduct 2 inventories, at ~12 and 6 months before the switch through a
direct physical count of all available tOPV stock and report to the level
above.
Collect and analyze inventory data prior to placing orders
National
yes
Applies to:
Regional
District
yes
yes
yes
Calculate tOPV requirements so that all tOPV be consumed by [Switch
day] with the exception of a minimal amount of extra supply used as
contingency stock to be able to respond to the risk of localized stockouts.
Estimate of tOPV
needs until the
switch and bOPV
after the switch for
your region or for
distribution to lower
levels.
Consider 2 methods:
yes
yes
yes
Distribute last
shipment of tOPV
and first shipment of
bOPV to lower
levels.
Communication
The consumption based method should be prioritized for distribution
from district to health facility level
yes
yes
yes
Use vaccine distribution during the months prior to the switch as an
opportunity to keep staff at lower levels informed about the
tOPV/bOPV distribution plan.
yes
yes
yes
a) in case of doubt about the size of the target populations, follow the
consumption-based formula: tOPV used over a given period =stock at the
beginning of a period + received stock – current stock .
b) for areas with reliable target populations use the following method:
((Annual target population of the region × number of doses needed per person ×
Wastage factor) × (number of days of stock to be delivered/365)) - (tOPV stock
remaining as reflected in the second inventory for this region)
 Compare the outcome of this method with the real consumption and
refer to the first method if the difference is too large.
8
HF
(yes)
Contingency plan
Develop contingency plans with the following elements:
a) keep buffer stocks of one week consumption at national and regional
levels;
b) ensure up to date information of tOPV stocks at lower levels: increase
reporting from lower levels to once a week for the last month before the
switch;
c) ensure all levels are aware of the procedures, know where the buffer is
and who to contact
d) ensure the availability of means of transport
e) ensure contingency funds available for unplanned emergency dispatch
of vaccines
Pull or Push
The actual exchange of leftover tOPV with bOPV on or shortly before
switch day can follow the pull method (the exchange takes place in the
district store) or the push (exchange at HF level) method. Consider
normal method of vaccine distribution in country – best is to stick to
what people are used to.
Handling tOPV
after the switch
1. Remove any remaining tOPV from the cold chain equipment
2. Note in stock registries the amount removed
3. Place in designated bags or containers and write the quantities in doses
and date removed from cold chain on the “tOPV for disposal” sticker
4. Transport it to the designated location to be collected/disposed of
through the chosen method as per the tOPV collection and disposal plan.
yes
tOPV disposal
Disposal should take place in accordance with national legislation.
In absence of national legislation, the preferred disposal methods are in
order of priority:
1. Co-incineration (suitable for both rural and urban areas)
2. Encapsulation (suitable for rural areas only)
3. Sanitary landfill (suitable for rural areas only): Dispose in fenced off
sanitary landfill with no recycling activities nor public access
yes
9
yes
yes
yes
yes
yes
yes
yes
yes
yes
(yes)
Only
in very
specific
cases
like
areas
with
limited
access
Staff at the Central Vaccine Store are responsible for:
1. Conducting and coordinating at the minimum two tOPV inventories
2. Reviewing and adjusting procurement plans/delivery schedules from suppliers/UNICEF/other
agency to avoid overstocking tOPV
3. Communicating the switch schedule and plans (distribution, collection and disposal) to lower
levels
4. Distributing last shipment of tOPV and first shipment of bOPV to lower levels, and organizing
in-country redistribution as required
5. Putting in place a contingency plan and maintaining a buffer stock for emergency deliveries
6. Collecting and disposing of excess tOPV after the Switch
1. Conduct inventories at Central Vaccine Store and coordinate inventories at lower
levels
Methodology.
 Conduct a direct physical count of all available tOPV stock in the Central Vaccines Store. Report data on
doses and not on vials, including data on the following:
 Date of inventory
 Stocks in doses:
o In systems
o Physical count
 Expiration date
 Manufacturer
 Packaging (number of doses per vial)
 Physical location of the stock
 Supply balances from recent SIA activities (if any)
 Orders recently received or pending, which are not yet recorded in stock records

Update data in the national stock management systems with the revised, accurate figures.
Coordination of stock inventories at all levels of the supply chain.
 Include all types of facilities and vaccine storage points in the inventory exercise, both in the public and
private sector, including pharmacies, warehouses or other locations providing or storing tOPV.
o A separate coordinating mechanism may be needed for private-sector facilities to report to staff at
the Central Vaccine Store.
 Communicate expectations to regional and/or district-level staff to make their responsibilities for the
inventories clear. A national-level directive from the Ministry of Health (i.e., letter or official circular) may
be necessary to direct the process and timeline for stock inventories.
 All levels should conduct their physical count within a one-week time frame to minimize the risk of
double-counting stock designated for delivery down the supply chain
 District and regional-level staff should report (via phone call or SMS message) total tOPV levels up the
supply chain, with the national-level staff receiving all data from regional-level stores.
 Aggregate all the data at the Central Vaccine Store level for analysis (see below).
2. Review and adjust procurement plans based on tOPV inventories
Collect and analyze inventory data prior to placing orders for tOPV needed up until the Switch.

Use the following formula to calculate the total quantity of tOPV on-hand:
10
CENTRAL VACCINE STORE STAFF
Central Vaccine Store


Calculate tOPV requirements so that all tOPV will be consumed by [Switch day] with the exception of a
minimal amount of extra supply used as contingency stock for response in the event of localized stock
outs.
One week of contingency stock should be stored at the Central Vaccine Store level. (Additional
contingency stock may also be held at the regional level. See #5 on contingency plan, below)
3. Communicate the Switch schedule and plan to lower levels
Use in-country distribution as opportunities to remind the regional staff of the Switch timelines and their
responsibilities for ensuring a complete switch on Switch day.
4. Distribute last shipment of tOPV and first shipment of bOPV to lower levels, and
organize in-country redistribution as required
Calculate quantity and distribute last shipments of tOPV.
 Use the consumption-based formula or target population method, as described above, to calculate the
amount of tOPV you must distribute to each region for the final delivery.
o If any contingency stock is also to be held at the regional level, include this amount in the
allocation and delivery for each region
 If there are Polio Supplementary Immunization Activities planned, include the quantity required in the
allocations delivered to each region
 It is important to note that the final delivery of tOPV may be a few months ahead of the Switch (e.g., if
delivering on a quarterly schedule, the final delivery to the region should be the January 2016 delivery.)
 Where the first inventory showed an overstock of tOPV of more than three months, adjust delivery for the
second to last-delivery as well, using the results from the first inventory.
Distribute adequate quantity of bOPV to Regional Vaccine Stores.
 Central Vaccine Store staff must develop a distribution plan and share it with lower levels. The bOPV
should be distributed early enough to arrive at the district level two weeks before the Switch.
o i.e., If regional distribution is on a quarterly schedule, the bOPV should be distributed with the
January 2016 wave in order to ensure onward distribution to the periphery in time.
 Ensure that distribution planning is factored into procurement timelines (and vice versa) for bOPV. For
example, a January 2016 delivery must be anticipated well in advance in order to ensure orders are placed,
funds are transferred, and licensing/registration requirements are met in time.
 Special delivery requirements (pre-inspection, additional documentation, etc.) should be minimized to the
extent possible for the first delivery. Early discussions on these issues with customs authorities, NRA, and
central medical stores is highly recommended.
 Quantities of bOPV for distribution to the regions should be calculated using routine forecasting methods.
Ensure that tOPV is clearly labeled and stored separately from bOPV.
 In order to avoid any risk of being mixed with tOPV deliveries and administered to patients prior to the
Switch, keep stocks of bOPV separate from tOPV while awaiting distribution.
 Store in different cold chain equipment where possible, or on different shelves or opposite sides
of the fridge
 Use special tOPV stickers on tOPV secondary packaging, if available (see example in Annex 1)
5. Coordinate contingency plan and maintain buffer stock for emergency deliveries

Store the equivalent of one week of national supply of tOPV at the Central Vaccine Store, ready for
distribution for any new/unscheduled delivery
11
CENTRAL VACCINE STORE STAFF
Total tOPV = Quantity in-stock – (expired tOPV stock) – (tOPV stock with VVM stage 3 or 4)

Dedicate a focal point to field emergency requests for additional supply of tOPV who has the authority to
allocate and distribute tOPV accordingly, either through:
a. Increasing quantity of next scheduled delivery, or
b. Dispatching an out-of-schedule delivery
Communicate to regional and district vaccine stores who to contact and under what circumstances
6. Dispose of excess tOPV after the Switch
Dispose of all tOPV in the Central Vaccine Store.
On Switch Day:
1. Remove any remaining tOPV from the cold chain in the central store
2. Note the amount of tOPV removed in stock registries
3. Place in designated bags or containers marked with the “tOPV for disposal” and write quantity in
doses and date of removal from the cold chain on the sticker (see Annex 1)
4. Transport it to the designated disposal site according to the national plan for tOPV collection and
disposal
Coordinate tOPV collection and disposal at lower levels if applicable as per the national tOPV
collection and disposal plan.
12
CENTRAL VACCINE STORE STAFF

Regional-level staff are responsible for:
1. Conducting and coordinating at the minimum two tOPV inventories, communicating the
inventory process to staff at lower levels of the supply chain, collating and reporting up the
inventory data received from district vaccine stores
2. Distributing adequate amounts of tOPV and bOPV to District levels on time for the Switch; and
organizing redistribution across districts as required
3. Communicating the switch schedule and plans (distribution, collection and disposal) to lower
levels
4. Understanding and putting in place the supply contingency plan communicated from Central
Vaccine Store
5. Collecting and disposing of excess tOPV according to guidelines.
1. Conduct inventories at Regional Vaccine Store and coordinate inventory at District
Level
Methodology.

Conduct a direct physical count of all available tOPV stock in the Regional Vaccine Stores. Report data
on doses and not on vials, including data on the following:
- Date of inventory
- Stocks in doses:
o In systems
o Physical count
- Expiration date
- Manufacturer and packaging (number of doses per vial)
- Physical location of the stock
- Supply balances from recent SIA activities (if any)
- Orders recently received or pending, which are not yet recorded in stock records
Coordination of stock inventories at District level.
 Communicate to district-level staff their responsibilities in the inventory, including the following:
o All levels should conduct their physical count within a one-week time frame to minimize the risk of
double-counting stock designated for delivery down the supply chain
o District staff should report (via phone call or SMS message) the total tOPV levels as outlined above
 Compile inventory data received from all district vaccine stores in the region, and collate together into a
single database. Report information up via phone call or SMS to the Central Vaccine Store, which is
responsible for collating all data nationwide.
 After the physical count is performed, update data in the national stock management systems with the
revised, accurate figures.
2. Distribute last shipment of tOPV and first shipment of bOPV to District level, and
organize redistribution within region if required
Calculate quantity and distribute final orders of tOPV.
 Use the consumption-based formula or target population method, as described above, to calculate the
amount of tOPV you must distribute to each region for the final delivery:
 As Switch Day draws closer, supplies should be calculated based on immunization activities planned
and previous consumption, and not just based on target beneficiaries.
 If delivering on a quarterly schedule, use this advice for your January 2016 delivery
13
REGIONAL LEVEL
Regional Vaccine Store
It is recommended for the Region to provide “tOPV collection forms” (Annex 2) along with the last tOPV
shipment, to be completed by Districts on [Switch day] to register all unused tOPV collected for disposal.
Distribute adequate quantity of bOPV to District Vaccine Stores.
 Regional Vaccine Store staff must develop a distribution plan and share it with districts. In order to ensure
that enough bOPV is available for administration immediately on the day of the Switch, bOPV should
arrive at the District Vaccine Stores at least two weeks before the Switch.
 Quantities of bOPV for distribution to districts should be calculated using routine forecasting methods.
Ensure that bOPV is stored separately from tOPV.
 In order to avoid any risk of being mixed with tOPV deliveries and administered to patients prior to the
Switch, keep stocks of bOPV separate from tOPV while awaiting distribution.
 Store on different shelves or opposite sides of the fridge
 Use special tOPV stickers on tOPV secondary packaging, if available (see example in Annex 1)
3. Execute Contingency Plan
To ensure that you have sufficient tOPV to last until the day of the Switch:
 When you receive your final tOPV delivery, conduct a physical count and compare to the total amount you
will be required to distribute to each District store;
 If there is a shortfall in the amount you received or gap due to higher than expected demand or wastage
(e.g. a temperature excursion), quantify the additional amount you require
 Call the identified focal point at the Central Vaccine Store and request the amount and date by when it is
required (if there is insufficient time to receive the supply before delivering supply to the next level through
the routine delivery schedule, Central Vaccine Store may choose to deliver directly to the level affected).
4. Dispose of excess tOPV after the Switch
National planners and the Central Vaccine Store manager will communicate to you the tOPV collection and
disposal plan and the role of the Regional Vaccine Store in implementing it.
Provide information to design tOPV collection and disposal plan.
 National-level planners will take the lead in defining a tOPV collection and disposal plan, however they
may call upon regional logisticians to participate in its creation. In particular, staff may be asked to:
o Collect and share data about available disposal facilities and tOPV collection means at regional level
o Check potential disposal sites for readiness so at regional levels the disposal plan can be adjusted if
necessary
Communicate disposal plan to district level and coordinate disposal (if relevant).
 Ensure that all selected disposal sites in the region are informed about their task and carry out the
necessary preparations
 Ensure, through the districts if appropriate, that all health facilities in the region, including private, with
tOPV receive a copy of the collection and disposal plan
Dispose of tOPV in the Regional Vaccine Store.
On Switch Day, regional-level logisticians must:
1. Remove any remaining tOPV from the cold chain in the regional store
2. Note the amount of tOPV removed in stock registries
3. Place in designated bags, or containers marked “tOPV for disposal” and write quantity in doses and
date of removal from the cold chain on the special tOPV sticker
4. Transport it to the designated location for collection/disposal, as per the national plan for tOPV
collection and disposal.
14
REGIONAL LEVEL

The role of District-level staff in the Switch will be to:
1. Conduct at the minimum two tOPV inventories and report results up to the Regional Vaccine
Store (or Central Vaccine Store where applicable)
2. Receive and properly store tOPV and bOPV in preparation for the Switch
3. Establish contingency plan
4. Distribute last shipment of tOPV and organize redistribution within district as required.
5. Implement Switch (three methods of distribution can be considered, detailed below: push
exchange, pull exchange, and where necessary, pre-positioning)
6. Collect and dispose of excess tOPV after the Switch
1. Conduct inventories at District Vaccine Store
Methodology.
 Conduct a direct physical count of all available tOPV stock in the District Vaccines Store. Report data
on doses and not on vials, including data on the following:
- Date of inventory
- Stocks in doses:
o In systems
o Physical count
- Expiration date
- Manufacturer and packaging (number of doses per vial)
- Physical location of the stock
- Supply balances from recent SIA activities (if any)
- Orders recently received or pending, which are not yet recorded in stock records
Reporting.
 Report information up via phone call to the Regional Vaccine Store.
 Update data in the national stock management systems with the revised, accurate figures
2. Receive and properly store tOPV and bOPV in preparation for the Switch
Ensure that bOPV is stored separately from tOPV.
 In order to avoid any risk of being mixed with tOPV and administered to patients prior to the Switch, keep
bOPV separate from tOPV while awaiting distribution.
 E.g. store in different equipment if available, or on different shelves or opposite sides of the fridge
 Use special tOPV stickers (see Annex 1) on tOPV secondary packaging, if available
3. Establish contingency plan
To ensure that all health facilities have sufficient tOPV to last until the day of the Switch, you will need to
implement a system to quickly reallocate stock between health facilities when a risk of localized stock out
arises.
Amount required for routine immunization:
 When you receive your final tOPV delivery, conduct a physical count and compare to the total amount you
will be required to distribute to each health facility
 If there is a shortfall in the amount you received or due to higher than expected demand or wastage (e.g. a
temperature excursion) quantify the additional amount you require
 Call the identified focal point at the Regional Vaccine Store and request the additional amount and date by
when you require it.
15
DISTRICT LEVEL
District Vaccine Store
4. Distribute last shipment of tOPV, and organize redistribution within district if
required
In general, as Switch Day draws closer, supplies provided to health facilities should be calculated based on
immunization activities planned and previous consumption, and not just based on target
beneficiaries. In preparation, it is important to strengthen mechanisms to review vaccine utilization (and not
just distribution), needs assessment and stock management.
5. Implement Switch: first shipment of bOPV to health facilities, collection of tOPV
On Switch day, all health facilities must stop tOPV usage. National planners will communicate guidelines on
how the Switch will be implemented in your country.
An “exchange” process (either “push” or “pull”) between tOPV and bOPV is preferable, in order to avoid
presence of tOPV in Health Facilities after the Switch day. However, national planners may recommend a
“prepositioning” mechanism under certain circumstances, e.g. for remote facilities with difficult access
(security, outbreaks, impracticable roads due to raining season). A mix of several methods may also be used.
Scenario 1:
Before the
Switch
On Switch
Day
(or day
before)
Risks
Benefits*
Organized “Push” - Exchange (with no Health Facility disposal)
Design a micro-plan/delivery schedule to visit every Health Facility in your district on Switch
Day or the day before, and secure the required transportation budget where applicable.
Visit each Health Facility to:
 Collect any remaining tOPV in their cold chain storage and dispose of it according to
guidelines and collection/disposal plan. Update stock ledgers accordingly.
 Put all tOPV in a plastic bag or containers marked with the appropriate sticker “tOPV for
disposal” (See Annex 1). Write the quantity in doses and date of removal from cold chain
on the sticker
 Deliver allocated bOPV supply
 Record the quantity of tOPV collected on the “tOPV collection form” (Annex 2).
Will require significant additional funding and logistical capacity, as districts will have to make
extra visits to all health facilities
Approach with greatest assurance that :
 All health facilities receive their bOPV uniformly on time
 tOPV is removed from Health Facilities on time
* Please note: Though districts may be using pull mechanism in normal operations, a “push” model for the
Switch may be more appropriate to ensure the success and validation of the Switch, even if this may entail
some extra effort on the part of the District.
Scenario 2:
Organized “Pull” - Exchange ( with no Health facility disposal)
16
DISTRICT LEVEL
Contingency Buffer Stock:
 Communicate to all the Health Facilities in your district how to contact you with any unexpected additional
need for tOPV
 Keep track of health facilities’ unused tOPV stock, in order to identify health facilities from which tOPV
stock could be relocated in the event of a localized stock out. More generally, keep track on how health
facilities are faring compared to recommended minimum and maximum stock levels.
 Increase reporting from lower levels to once a week for the last month before the switch.
 Be prepared to swiftly distribute or dispense any additional amount required to Health Facilities up until
the Switch Day.

Scenario 3:
Prepositioning bOPV stock at Health Facilities
Before the
Switch


1 month prior: Communicate by phone, SMS or in person to every Health Facility the date
and time on which they must travel to the District Vaccine Store to drop off remaining
tOPV and pick up their allocation of bOPV
 2 days prior: Remind all Health Facilities that they MUST bring their remaining tOPV
supply in order to receive their bOPV supply
 Ensure that funds are available at District Vaccine Store to reimburse transportation costs
for Health Facility staff to travel for the exchange
On “pick
 Record each Health Facility that successfully exchanges its tOPV for bOPV, and record the
up” day
quantity of tOPV collected on the “tOPV collection form” (Annex 2).
 Put all tOPV in a plastic bag or containers marked with the appropriate sticker “tOPV for
disposal”. Write the quantity in doses and the date of removal from cold chain on the sticker
(see example in Annex 1)
 Record any Health Facility that forgets to bring their tOPV
o If Health Facility-based disposal is NOT allowed: Do not issue bOPV and instruct them
to come back the following day/or note that you will need to visit them directly to
distribute bOPV and pick up tOPV
o In the rare instances where HF-based disposal is allowed: Instruct them on how to destroy
their remaining tOPV before issuing their bOPV
After “pick  The next day: Contact all Health Facilities that did not exchange, to remind them to bring
up” day
tOPV and pick up bOPV
 Within three days after Switch day: Directly visit all remaining Health Facilities to collect
remaining tOPV and deliver bOPV
Risks
 Possibility for incomplete and untimely exchange of bOPV for remaining tOPV stock, if
Health Facility staff are unable/unwilling to travel on designated day
 Possibility of missed immunization sessions given health care worker time to travel and
exchange, unless the Switch day is scheduled the day after a day-off
 May require additional funds for “mop up” activities on the part of the District Vaccine
Store
Benefits
Less resource intensive for district-level staff than a full “push” delivery of bOPV
On Switch
Day
(Least Stringent: Health Facility Disposal allowed, validation criteria is tOPV usage)
Create a microplan listing each Health Facility that receives vaccine supply from you
Communicate with every Health Facility regarding Switch date, and follow up with regular
reminders
 Preposition bOPV stock through routine deliveries prior to the Switch
 Remind Health Facilities to store bOPV and tOPV in separate places within cold storage to
reduce confusion. It is recommended to also provide health facilities with stickers “tOPV for
disposal on [Switch date]” to clearly mark the secondary packaging on tOPV. (see Annex 1)
 Stickers should also be placed on designated disposal bags containing all tOPV on the day of
the Switch.
Communicate (in person, via phone, or by SMS) to each Health Facility to stop using tOPV
stock and remove from the cold chain, and begin using bOPV instead.
 Instruct Health Facilities to put tOPV stock in a closed bag, identified with appropriate
sticker “tOPV for disposal on [Switch date]”. Quantity in doses and date of removal from
cold chain should also be recorded (see example in Annex 1)
 If Health Facility-based disposal is allowed: Instruct Health Facilities to dispose of excess tOPV
according to disposal guidelines
 If Health Facility-based disposal is NOT allowed: Instruct Health Facilities to set tOPV bags aside
17
DISTRICT LEVEL
Before the
Switch
Benefits
for collection
 Incomplete and untimely exchange of bOPV for remaining tOPV stock, as there may be
confusion or reluctance to Switch tOPV for bOPV
 Less ability to monitor actual Switch and oversee wastage disposal
Less resource intensive than a full “push” or “organized pull” system, and can be performed
through routine systems
6. Dispose of excess tOPV after the Switch
The national or regional level will communicate the tOPV collection and disposal plan and the role of the
District Vaccine Store in implementing it.
Provide information to design tOPV collection and disposal plan:
 District-level staff may be asked to
o Collect and share data about available disposal facilities at district and health facility levels, and
available tOPV collection means
o Check specific potential disposal sites for readiness so the disposal plan can be adjusted if necessary
Communicate disposal plan to Health facilities and disposal sites, and coordinate disposal if relevant.
 Ensure that all selected disposal sites in the district (if any) are informed about their tasks and that they
carry out the necessary preparations
 Ensure that all health facilities in the district, including private sector facilities, with tOPV receive a
copy/are aware of the collection and disposal plan and their responsibility with respect to disposal of
tOPV
 Communications for health facilities about tOPV collection and disposal methods can easily be included as
part of the information provided about the Switch during routine vaccine distribution points.
Dispose of tOPV in the District Vaccine Store.
On Switch Day, district-level logisticians must:
1. Remove any remaining tOPV from the cold chain in the district store
2. Note the amount removed in stock registries (record in doses, not vials).
3. Place in bags or containers marked with the appropriate sticker “tOPV for disposal”. Write the
quantity in doses and date of removal from the cold chain on the sticker. (see example in Annex 1)
4. Transport it to the designated disposal site or collection point, as per the national plan for tOPV
collection and disposal.
18
DISTRICT LEVEL
Risks
Health Facility Staff are responsible for:
1. Communicating tOPV inventories to upper levels as required
2. Communicating any unplanned tOPV needs through the contingency mechanism
3. Executing the Switch (three scenarios detailed below)
4. Disposing of tOPV, only in the special case where Health facility-level disposal is authorized by
national planners.
1. Communicate any unplanned tOPV needs through contingency mechanism
In order to minimize excess tOPV that must be disposed of after the Switch, tOPV stock leading up to the
Switch will be minimal. Therefore, any unexpected wastage or demand will leave a Health Facility at greater
than normal risk of stock out.
However, tOPV administration must continue as normal until the day of the Switch. Therefore:
 When you receive your final tOPV delivery, conduct a physical count and compare to the total amount you
require for administration until the day of the Switch
 If there is a shortfall in the amount of tOPV you received or gap due to higher than expected wastage (e.g.
a temperature excursion) or demand, quantify the additional tOPV amount you require
 Call or SMS the identified focal point at District Vaccine Store and request the additional amount and date
by when you require it.
2. Execute the Switch
On the day of the Switch, all health facilities must stop tOPV usage. National planners will communicate
guidelines on how the Switch will be implemented in your country. An “exchange” process (either “push” or
“pull”) between tOPV and bOPV is preferred, in order to avoid presence of tOPV in Health Facilities after the
Switch. However, a “prepositioning” mechanism may be needed under certain circumstances, e.g. for facilities
with difficult access.
Scenario 1: Organized “Push” - Exchange (with no Health Facility disposal)
 Collect and submit all tOPV remaining in the facility’s fridge to the District representative when they
arrive at the Health Facility.
 You must be absolutely sure not even one vial of tOPV remains in the facility.
o Put all tOPV stock in a closed bag, identified with appropriate sticker “tOPV for disposal” and
write the quantity in doses and date of removal from the cold chain on the sticker. (see Annex 1)
o Note in stock registries the amount removed
 Begin administering and recording bOPV on the day of the Switch and going forward
Scenario 2: Organized “Pull” - Exchange ( with no Health facility disposal)
 On the scheduled day communicated to you by the District Vaccine Store, travel to the District Vaccine
Store with your remaining tOPV in order to pick up your allocation of bOPV.
o Put all tOPV stock in a closed bag, identified with appropriate sticker “tOPV for disposal” and
write the quantity in doses and date of removal from the cold chain on the sticker.
o Note in stock registries the amount removed
 Exchange tOPV for bOPV
 Begin administering and recording bOPV on the day of the Switch and forward
Scenario 3: Prepositioning bOPV stock at Health Facilities
 In order to avoid any risk of being mixed with tOPV and administered to patients prior to the Switch,
19
HEALTH FACILITY
Health Facility Level

make sure to keep bOPV separate from tOPV before the Switch.
On the scheduled day communicated to you by the District Vaccine Store, remove tOPV from the cold
chain and dispose/set aside according to guidelines (TBD)
o Put all tOPV stock in a closed bag, identified with appropriate sticker “tOPV for disposal” and
write the quantity in doses on the sticker. (see example in Annex 1)
Begin administering and recording bOPV on the day of the Switch and forward
3. Dispose of excess tOPV after the Switch
After the Switch, tOPV must be rapidly disposed of to eliminate the risk of poliovirus infections. A tOPV
collection and disposal plan for the country will be communicated to each health facility, including the role of
Health-facility logisticians in executing this collection and disposal plan.
Scenarios 1 and 2: Exchange (with no Health Facility disposal)
Confirm no tOPV remains in the cold chain.
As your remaining tOPV has been submitted to/collected by the District, no tOPV should remain in the cold
chain at the health facility on Switch day, and the District level will ensure the disposal of the collected tOPV.
Therefore, on Switch Day :
 Confirm that no more tOPV remains in the cold chain
 If for some reason a small amount of tOPV was overlooked when the tOPV was submitted to/collected
by the District level:
1. Remove the tOPV from the cold chain
2. Note in stock registries the amount removed
3. Place in designated bags, or containers marked “tOPV for disposal” and write the quantities in
doses and date of removal from the cold chain on the tOPV disposal sticker (see example in
Annex 1)
4. Notify the District Level for guidance on collection/disposal
Scenario 3: Prepositioning bOPV stock at Health Facilities
Dispose of tOPV.
On Switch Day:
1. Remove any remaining tOPV from the cold chain equipment
2. Note in stock registries the amount removed
3. Place in designated bags, or containers marked “tOPV for disposal” and write the quantities in doses
on the sticker
4. Transport it to the designated location for collection/disposal OR set aside for collection by District,
as per the tOPV collection and disposal plan
20
HEALTH FACILITY

Annex 1: Labelling of tOPV bags/containers for disposal
Bags or containers for tOPV that has been removed from the cold chain after the
national switch day should be clearly marked as not for use.
It will be essential for any labelling to also show the date after which tOPV should not be used.
Below is an example of such a sticker for labelling purposes.
Countries may also wish to print stickers for labelling secondary packaging on tOPV prior to the Switch, to
clearly distinguish it from bOPV and mark for disposal on Switch Day.
Date withdrawn from cold chain:_______
Quantity in doses: ___________________
21
Annex 2: Sample tOPV collection form
It is recommended that Districts keep a record of all tOPV collected from each facility on Switch day.
If Districts will be passing the tOPV up to a higher level (regional or central) for disposal, these forms should
be modified for use at the regional and/or central levels to record tOPV collection as well.
tOPV Collection Form – District level
Name/ID of Facility
District Name:
Quantity of tOPV
collected (# doses)
22
Signature of
responsible staff
Date
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