Switch from tOPV to bOPV
Walk-Through Guide for Development of
National Switch Plan
Table of Contents
Preparation Prior to Visit ............................................................................................................................................4
Walk-through Guidelines ............................................................................................................................................6
Executive Summary ....................................................................................................................................................7
Opening Questions .....................................................................................................................................................7
1.
Management, coordination and validation mechanisms ...................................................................................7
1.1.
Management Committees/Structure .........................................................................................................7
1.1.1.
Organization Chart with Roles and Responsibilities ...........................................................................7
1.1.2.
Operations Center ..............................................................................................................................8
1.1.3.
Points of Contact ................................................................................................................................8
1.1.4.
Workplan and Timeline ......................................................................................................................8
1.2.
Validation Mechanism ................................................................................................................................8
1.2.1.
2.
3.
1.2.1.1.
Roles and Responsibilities ..............................................................................................................8
1.2.1.2.
Validation and Reporting Process...................................................................................................9
Budget ................................................................................................................................................................9
2.1.
Funding Secured .....................................................................................................................................9
2.2.
Resources................................................................................................................................................9
Supply .................................................................................................................................................................9
3.1.
4.
National Switch Validation Committee (NSVC) ......................................................................................8
Supply Assessment .....................................................................................................................................9
3.1.1.
Supply and distribution of OPV from Central level to Periphery .......................................................9
3.1.2.
tOPV Stock Management and Inventories .........................................................................................9
3.1.3.
tOPV Forecasting, Ordering, and Shipment Planning Process ........................................................ 10
3.1.4.
bOPV Procurement and Distribution Plan ....................................................................................... 10
3.1.5.
Private Sector .................................................................................................................................. 10
Implementation Preparation ........................................................................................................................... 10
4.1.
Logistics ................................................................................................................................................... 10
4.1.1.
Cold Chain Capacity ......................................................................................................................... 10
4.1.2.
Transport System- Reverse Logistics System to Collect tOPV ......................................................... 11
4.1.3.
tOPV Disposal .................................................................................................................................. 11
4.2.
Update Information Systems................................................................................................................... 11
Switch from tOPV to bOPV Template for National Operational Plans

4.3.
Communications ...................................................................................................................................... 11
4.4.
Training Materials and Preparation......................................................................................................... 12
4.5.
Switch monitoring ................................................................................................................................... 12
4.5.1.
Process monitoring: assessing switch activities milestones ........................................................... 12
4.5.2.
Independent monitoring: validation of tOPV removal & disposal .................................................. 12
4.6.
Risk Identification and Mitigation ........................................................................................................... 12
Annex ....................................................................................................................................................................... 13
Checklist for Field Visits ....................................................................................................................................... 13
tOPV Withdrawal Validation Forms..................................................................................................................... 13
Guide for Timeline of Switch Activities ............................................................................................................... 14
Preparation Prior to Visit
Participants
The following is a proposed list of staff that may be involved in the switch and should be present during your
visit. Staff participation may vary by activity type, i.e. national staff should be present for high-level budget and
planning discussions while district and health workers should be involved with field visits to health facilities and
vaccine depots.
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Global and regional level
o 2-3 individuals
National
o EPI manager
o Central cold stores manager
o Finance staff
o Licensing and regulatory staff
o Health information system staff
o Communications staff
o Representatives from the private sector
Sub-national (e.g. 1-2 states or provinces)
o EPI coordinator
o Cold stores manager
District (e.g. from approx. 2-4 districts)
o EPI coordinator
o Cold stores manager
Health facility (e.g. 2-4 districts)
o Front line health workers
In-country partners
o WHO, UNICEF, others as appropriate
Scheduling Field Visits
Work with regional and national staff to schedule visits to district offices, vaccine depots, and health facilities in
order to observe tOPV inventories and distribution in the cold chain, options for tOPV disposal, training of
independent monitors, etc.
Materials
Request the following documents from country staff AHEAD OF YOUR VISIT
1.
2.
3.
4.
5.
6.
7.
8.
Vaccine inventories and location
Examples of stock registers and reports
Examples of immunization registers and reports
Unused immunization cards
Disposal site and equipment information
Past SIA budgets
Information on the immunization information system
Examples of training materials
Example agenda for on-site visit
Approx. time (days)
Pre-visit
0.5 – 1
1
1–2
0.5 – 1
0.5 – 1
Post-visit
Sequence of activities
• Advance dissemination of background docs to selected participants
• Receive background docs from country, and review by the global team
• Pre-briefing with key national level managers on objectives
• Briefing with all participants – introductions, objectives, the switch
• Discussion of local considerations related to the programme
• Deep dive into operational guidance for implementing the switch
• Desk-based walk-through of the steps to plan and implement the switch, focusing
on key functional areas and phases of work
• Field visits for data collection: tOPV inventories and distribution in cold chain,
options for disposal, training of independent monitors, etc.
• Debrief on the field visits and walk-through: risks, barriers, facilitators, potential
solutions, implications for planning and timing, overall learning
• Draft outline of the national switch plan. Includes key operational steps and
overall budget. Discuss next steps. Debrief with national managers
• Consult on and finalize national switch plan
• Draft the “dry run debrief” with focus on learning and implications
Walk-through Guidelines
Consultants should be familiar with the following documents and tools prior to arrival in country.
Key Documents
1.
2.
3.
4.
5.
Switch Guidelines
Switch Plan Walk-Through Guide
Template Switch Plan
Switch Assessment Tool
Independent Monitoring Guide
Planning Tools Available
1.
2.
3.
4.
5.
Switch Budget Tool
Stock Management Tool
Training Material Templates
Timeline of Activities
Information Flow Guide
This guide is based on the Switch Guidelines and is designed to provide discussion and decision points needed
to develop a Switch Plan, it is intended to be used alongside the Template Switch Plan which can be filled out
based on in-country discussions. The guide incorporates questions the consultants should ask in order to
develop activity descriptions, identify roles and responsibilities, timelines, and to capture an adequate level of
detail by the Switch Plan to ensure the Switch can be implemented on time according to the global schedule.
Use the planning tools as needed in order to expedite the planning process.
Key for Guide
 Questions or suggestions to guide the
discussion
 Identifies sections where a planning tool can
be used to assist with making decisions
Required elements to be included in the
Switch Plan
Tips:
o Consider working backwards in time through the planned activities, as needed
o Identify those activities that will need additional follow-up
o Be as specific as possible with how each activity will be implemented
This walk-through guide may be accompanied by the Switch Assessment Tool which will allow consultants to
document major challenges, barriers, facilitators, and needs of each country to implement the switch.
Walk-Through
Executive Summary
Include the following:
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Summary of the Switch activities
Date selected for the National Switch Day
Overview of national coordination mechanism to ensure a successful Switch
Overview of monitoring and supervision mechanism
Overview of validation mechanism
Current procurement process (UNICEF or self-procuring)
Budget and funding sources
Proportions public versus private use of tOPV
Opening Questions
 Is this a self-procuring country? Do they receive vaccine supply through UNICEF?
 Does this country have past experience switching vaccines within the EPI program?
 Ask for any training, communications materials, current vaccine reporting and ordering forms in
advance to facilitate discussions
 Any existing data on current tOPV inventory and proportion distribution of tOPV across types of
cold stores (national, regional, district/provincial, primary health center or service point)
1. Management, coordination and validation mechanisms
1.1. Management Committees/Structure
The management committees will have to assist with planning, managing, and overseeing all Switch
activities, including selecting the National Switch Day. This committee is different from the National Switch
Validation Committee (NSVC). Do not create new structures. Use existing mechanisms such as interagency
coordination committees (ICCs)
o
o
National and sub-national Switch Committees (e.g., ICC)
Switch Support Teams
Review which staff are currently involved with the EPI program, including supply and finance,
and go over their roles and responsibilities. This will create a starting point for the discussion of
how their roles will change for the Switch.
1.1.1. Organization Chart with Roles and Responsibilities
Develop an Organizational Chart for each of the management groups, committees, and support teams
that indicates how disseminating information and reporting data will flow between each entity.
CONCEPT NOTE
Draft: 2 April 2015
1.1.1.1.National Management Structure
Establish a national management structure or re-establish the working groups used during SIAs. This could be
an Interagency Coordination Committee (ICC), a National Switch Committee (NSC) or something similar that
would oversee all switch activities.
 Who should be included from the MOH?
 Which partners should participate? Finance, procurement, regulatory, and legal authorities outside
the MOH may need to be included.
1.1.1.2.Sub-national Switch Committees
 Will sub-national switch committees be needed? Which staff will be included?
1.1.1.3.Switch Support Teams
 Will support teams be needed for particular activities? Will new staff need to be hired?
 How many members will need to be involved during each phase of the preparation process?
 How many members from each level should be involved during each phase?
 What mechanism will be used to hire or delegate staff to switch support team(s)?
1.1.1.4.Information Flow
 Outline reporting and information flows and frequency between committees and teams
 Information Flow Guide- To be developed
1.1.2. Operations Center
 Will an Operations Center be necessary to help coordinate national and regional activities?
1.1.3. Points of Contact
Focal points will be needed to answer both public and professional inquires. A roster with contact
information should be developed.
 Who will be the focal points for all national and regional committee members?
 Where will this roster be stored? Who will have access to it?
1.1.4. Workplan and Timeline
 Which day during the first 2 weeks of April 2016 will be National Switch Day?
 What will be the timeline for tOPV withdrawal and bOPV delivery at each distribution level?
 Are the switch activities synchronized with any other planned public health or immunization
activities?
 Timeline of Activities
1.2. Validation Mechanism
1.2.1. National Switch Validation Committee (NSVC)
The NSVC could comprise experts in public health, epidemiology, logistics, and clinical medicine who would
be independent of the Switch implementation (i.e. not part of the Switch Committees).
1.2.1.1.

Roles and Responsibilities
Develop an organizational chart with roles and responsibilities for the NSVC and the switch
monitors
CONCEPT NOTE
Draft: 2 April 2015
1.2.1.2.

Validation and Reporting Process
Develop a workplan and timeline for monitoring and validation activities
2. Budget
 Switch Budget Tool- Use tool to estimate budget needed to implement the switch
2.1. Funding Secured
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What funding sources are available?
How much funding is available?
When will the funds become accessible?
Who will manage the funds?
Discuss how unexpected expenses will be dealt with; can a contingency fund be developed?
2.2. Resources
 What other demands will be placed on vaccination program resources before and during the
switch?
 Are any predictable events, such as elections, going to occur that could complicate the switch?
 What resources within a national vaccination program are available to help with the switch?
 Are any resources external to the vaccination program available to help with the switch?
3. Supply
 Stock Management Tool
For each level of the health system, determine how best to diminish the stock of tOPV while
simultaneously delivering bOPV to all health facilities without wasting large quantities of tOPV
and ensuring all facilities have bOPV by the Switch Day. Additional efforts for monitoring stock
management of both vaccines may be required.
3.1. Supply Assessment
3.1.1. Supply and distribution of OPV from Central level to Periphery
 How is vaccine procurement organized: through procurement agency, directly by MOH, or a mix?
 How does the procurement process differ by health system level?
 Are there certain areas with restricted access?
3.1.2. tOPV Stock Management and Inventories
 Two inventories should be conducted, first inventory as soon as possible prior to switch and second
inventory 6 months prior to switch.
 When will the current stock balances be assessed? Balances need to be assess at national,
subnational, and at least one inventory should assess inventory at the district level or lower.
 How often are physical inventories conducted?
 What system is used at the regional and national levels to monitor the stock?
3.1.2.1.Stock of tOPV
 What is the tOPV stock status at national, regional, and district levels?
 What is the periodicity of tOPV supply to the country, regions and district?
CONCEPT NOTE
Draft: 2 April 2015
3.1.3. tOPV Forecasting, Ordering, and Shipment Planning Process
 How will the current procurement plans for tOPV be adjusted? Ordering cycles should be
maintained, but a situational analysis may need to be completed to minimize risk of overstock.
3.1.4. bOPV Procurement and Distribution Plan
3.1.4.1.Licensing and regulatory approvals of bOPV
 Does the country accept bOPV for routine immunization based on WHO Prequalification or is a
national licensure required, and is this based on an expedited procedure or full national licensure?
 If licensure is required, has the process for NRA licensing of bOPV for routine begun?
 What is the standard timeline for licensure? Is the country willing to provide an emergency waiver
for initial importation if licensure not initiated or completed before the Switch?
 What is the actual licensure status of the bOPV that will be used?
 Are there specific requirements in respect to local customs regulations, requirements for predelivery inspection, or special documentation requirements? Will these cause a delay? How will
delays be handled?
3.1.4.2.Procurement and Distribution of bOPV
 Has a 3-6 month supply of bOPV been procured?
 Can bOPV be delivered 1-3 months prior to the Switch?
 How will bOPV be distributed to the periphery prior to the Switch? When will this distribution
occur?
 Will the distribution of bOPV be involved with the return or destruction of tOPV? For example, will
the districts exchange bOPV for tOPV when delivering bOPV?
3.1.5. Private Sector
 How much tOPV is offered in the private sector and in which facilities (NGOs, hospitals, private
clinics, and/or pharmacies)?
 Is there informal delivery of tOPV in the private sector (e.g., unregulated pharmacies/dispensaries,
traditional healers, local untrained pharmacy dealers)?
 How and from where does the private sector source and procure their tOPV (from local
agents/suppliers, directly from suppliers)?
 Does the National Regulatory authority or other relevant agency have regulatory oversight over
medical supplies imported into the country and delivered through the private sector?
 How can the private sector in participating in the Switch and through which associations/agencies
(e.g., NRA, National Medical Council, ministry of commerce, etc.)?
 How will the withdrawal of tOPV from the private sector be monitored and managed?
4.
Implementation Preparation
4.1. Logistics
4.1.1. Cold Chain Capacity
Consider the need to do a cold chain capacity assessment; dependent on tOPV campaigns or other
immunization program activities being conducted prior to the Switch.
 When was the last cold chain assessment completed? At which levels?
CONCEPT NOTE
Draft: 2 April 2015
 What is the cold chain capacity at the district, sub-national, and central levels?
 Will temporary storage capacity be needed particularly at central, subnational and district levels
where bOPV and tOPV will be simultaneously stored for a few weeks to a months? Provide a plan to
address any deficiencies.
 Can private sector facilities be identified if additional vaccine storage is needed?
4.1.2. Transport System- Reverse Logistics System to Collect tOPV
 For tOPV that cannot be destroyed on-site, what transport system is available for tOPV withdrawal?
 How will bOPV be delivered to the periphery?
o Does the frequency of deliveries need to be increased?
o Does the type of vehicle or vaccine carrier need to be changed?
4.1.3. tOPV Disposal
 What are the current biological waste management processes and policies at facilities at all levels?
 How is medical waste disposal organized and how can disposal of tOPV be aligned with these
guidelines, using WHO guidance?
 Can the current process be used to dispose of tOPV?
 Will a new disposal policy need to be developed that is specific to tOPV?
 What is the estimated disposal volume? At each level of the health system?
 How will health workers withdrawal tOPV from the cold chain?
 Estimate disposal volume- Annex 5 of Switch Guidelines
4.1.3.1.Disposal site selection
 Is there an inventory of all disposal equipment in the country? If so, when was it last updated?
 What sites are appropriate for tOPV disposal? Are these the same at each level of the health
system?
4.1.3.2.Disposal policy and monitoring
 What will be the recommended tOPV disposal policy?
 Who in the health system will need to be notified/reminded of this policy?
 Will the disposal of tOPV be monitored? If so, incorporate the monitoring strategy into the overall
switch monitoring plan.
4.2. Update Information Systems
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Will forms, vaccination cards, or electronic databases, etc. need to be updated? What is the
timeline necessary to change, print, and distribute these items prior to the switch?
Compare different scenarios for the need to make updates to the system with other upcoming EPI
program changes (i.e., additional vaccine introductions, scheduled updates to electronic
databases, etc.) and timelines need for making modifications.
4.3. Communications
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What is the plan for disseminating information to all levels? All partners and stakeholders?
What will be the frequency of communications?
How will political and opinion leaders at the national, regional, and district levels be sensitized?
What are the main barriers and enablers to the switch?
What is the plan to address potential issues?
How will solutions be communicated to key stakeholders?
How will unexpected events and crises be communicated?
CONCEPT NOTE
Draft: 2 April 2015

How will communication activities be monitored?
4.4. Training Materials and Preparation
 Templates for training materials: http://tinyurl.com/ipv-intro

What materials will need to be developed for health workers? (i.e., FAQs, fact sheets, training
materials, videos, and posters)
4.5. Switch monitoring
Explain how all aspects of the Switch will be monitored:
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Preparedness
Implementation of Switch
Withdrawal and disposal of tOPV
Reporting mechanisms
Identify whether any additional staff will be recruited or resources needed
for these monitoring activities.
4.5.1. Process monitoring: assessing switch activities milestones
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What indicators will the NSC or ICC use for ensuring the switch is on track?
How will these indicators be monitored? How frequently?
How will these indicators be reported? To whom? How will this differ at each level of the health
system?
How will the indicators be reported to the WHO or UNICEF offices? Will all indicators be reported?
How frequently will they be reported?
4.5.2. Independent monitoring: validation of tOPV removal & disposal
Validation will occur within 2 weeks of the National Switch Day.
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How will the withdrawal of tOPV be validated?
What indicators will the NSVC need to validate the withdrawal of tOPV from the cold chain?
When will results be reported to the RCC?
Who will be responsible for selecting the Independent Switch Monitors, supervisors, and
coordinators?
When will micro-plans for switch monitoring need to be completed?
How will data from switch monitoring be aggregated and reported?
4.6. Risk Identification and Mitigation
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How will tOPV stockouts before the switch be avoided?
What will be done if tOPV is found in one or more cold chain stores or health facilities after the
switch?
How will bOPV stockouts after the switch be avoided?
What will be done if some areas are ready to switch to bOPV on schedule but others are not?
What will be done if independent monitoring results are not available before the validation date?
CONCEPT NOTE
Draft: 2 April 2015
Annex
Checklist for Field Visits
Information obtained from…
tOPV Withdrawal Validation Forms
See Switch Guidelines.
Guide for Timeline of Switch Activities
2016
2015
Activity
Plan
Establish management structure
Establish National Switch Validation Committee (NSVC)
Conduct situational analysis
Draft national switch plan
Prepare
Detailed tOPV inventory; adjust tOPV delivery
Funding secured
Monitoring plan
Last tOPV inventory; adjust tOPV orders and/or delivery
Order bOPV
Waste management assessed
Switch support staff hired
Last tOPV delivery to country
Redistribute tOPV stock in country as required
Prepare training materials and implement
communications strategy
bOPV deliveries to country begin
Last 1-2 months of tOPV delivered to periphery, with
redistribution in country as required
Identify Switch Monitors
Implement
Train Switch Monitors
Train health workers
Distribute bOPV to periphery and service points
National Switch Day
Stop use of tOPV and remove tOPV from cold chain
Begin use of bOPV
Validate
Complete disposal of tOPV
Switch monitors to validate at selected sites
Report to NSVC; NSVC reviews data and validates Switch
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr/Switch
Day
Onwards