Global Polio Eradication Initiative - cold chain logistics and vaccine management during polio supplementary immunization activities
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IN SUPPORT OF THE Global Polio Eradication Initiative GUIDANCE NOTE ON cold chain logistics and vaccine management during polio supplementary immunization activities
ACKNOWLEDGEMENTS The UNICEF polio team developed this guidance note with inputs from immunization unit, health section/ programme division, supply division, UNICEF regional and country offices and GPEI partners. November 2015 Cover Photo: © UNICEF/PFPG2014P0965/Niaz Inside Cover Photos: © WHO/T.Moran © UNICEF/Noorani © UNICEF/M.Shafiq The material in this publication has been commissioned by the United Nations Children’s Fund (UNICEF) in support of the Global Polio Eradication Initiative (GPEI). The contents do not necessarily reflect the policies or the view of UNICEF or GPEI. For more information please contact: Health Section/ Programme Division 3 United Nations Plaza, New York, NY 10017, USA Disclaimer: Proprietary or manufacturers’ names mentioned in this document do not constitute any endorsement of their product(s) or services. ISBN: 978-92-806-4796-9
IN SUPPORT OF THE Global Polio Eradication Initiative GUIDANCE NOTE ON cold chain logistics and vaccine management during polio supplementary immunization activities
CONTENTS Executive summary 1 Introduction 3 Purpose of a guidance note on CCL&VM in polio SIAs 4 Scope of this guidance note 5 CCL&VM in the context of the Polio Eradication and Endgame Strategic Plan (PEESP) 8 Overview of CCL&VM systems in polio SIAs 10 Common challenges observed in CCL&VM in polio SIAs 14 Vaccine usage, wastage and multi-dose vial policy (MDVP) 18 IPV campaigns 22 Monitoring performance on CCL&VM for polio SIAs 24 Standard Operating Procedures for SIA polio vaccine management (SOP-VM) 28 Roles and responsibilities in supporting CCL&VM activities for polio SIA 30 Conclusion 31 Annexes 32 Annex 1: Key activities, processes, results and indicators for CCL&VM performance in polio SIAs at national, regional and global levels 33 Annex 2: Standard Operating Procedures for vaccine management (SOP-VM) 41 Annex 3: Tools and resources 48 References 49
LIST OF TABLES Table 1: OPV, measles and IPV campaigns: Key differences in technical, operational and communication domains 6 Table 2: Examples of vaccine wastage 18 Table 3: Wastage rate, wastage multiplication factor and vaccine requirement 19 Table 4: Useful norms for calculating vaccine and other logistics requirements for OPV and IPV campaigns 21 Table 5: Polio Oversight Board (POB) indicators on CCL&VM: measured on a quarterly basis and reviewed at the global level 25 Table 6: UNICEF management dashboard indicators for programme monitoring CCL&VM in SIA in endemic countries 26 Table 7: Additional indicators for monitoring CCL&VM performance in polio SIAs at sub-national level 27 Table 8: National level: Key activities, processes, results and indicators for CCL&VM before, during and after polio SIA rounds 33 Table 9: Regional level: Key activities, processes, results and indicators for CCL&VM before, during and after polio SIA rounds 37 Table 10: Global level: Key activities, processes, results and indicators for CCL&VM before, during and after polio SIA rounds 39 Table 11: Key operational procedures and use of VBSI and VUR forms 45 LIST OF FIGURES Figure 1: Bundled vaccines and vaccination equipment as well as information for inventory control must flow up and down the logistics chain 13 Figure 2: Schematic diagram for usual (same as in routine immunization) and alternate vaccine delivery plans during SIAs 17
Executive summary The Global Polio Eradication Initiative (GPEI) was established in 1988 when there were an estimated 350,000 polio cases reported from 125 endemic countries. Since then there has been tremendous progress towards global polio eradication, and by September 2015 only two countries continued to have endemic transmission of wild polio virus: Afghanistan and Pakistan. Building high population immunity to poliovirus infection through routine immunization as well as through supplementary immunization activities (SIAs) is key to polio eradication. UNICEF, as one of the spearheading partners of GPEI, is the lead agency for procuring, supplying and managing vaccine logistics in polio-affected countries. In 2014, UNICEF procured more than 1.7 billion doses of oral polio vaccine (OPV) and delivered those to over 60 countries for use in SIA and routine immunization. In addition, more than 8 million doses of inactivated polio vaccine (IPV) have also been delivered for SIAs primarily in the endemic countries and Nigeria. The magnitude of annual vaccine procurement and utilization by GPEI and the urgency for achieving polio eradication has further underscored the need to rapidly develop clear guidelines and tools for improving vaccine management in the context of polio SIAs. This guidance note aims to summarize critical technical concepts and activities to be implemented before, during and after polio SIAs in the domain of cold chain logistics and vaccine management (CCL&VM). The guidance note was developed in consultation with experts in countries, regions and partner organizations. After a brief overview of SIA approaches in the context of the Polio Eradication and Endgame Strategic Plan 2013– 2018, the guidance note highlights common challenges encountered in polio SIAs and consolidates key lessons learnt and available resources and tools. We expect that application of these guidelines will help country immunization programmes manage a valuable resource like polio vaccines more efficiently and effectively. The guidance note also references examples demonstrating how polio eradication programme and routine immunization can mutually benefit each other. We believe this guidance note would also contribute to the broader efforts made to strengthen overall immunization supply chain and cold chain and logistics including that for non-polio SIAs as part of the GPEI legacy. We request your kind support in adapting and implementing this guidance note towards improving polio vaccine management. Polio programme staff remain readily available to extend support to countries and regions as we work together towards achieving global polio eradication. 1
“ The world has a historic opportunity to eradicate polio, once and for all. UNICEF is committed to playing a central role in this effort. As previously noted, doing our part in the global eradication effort is a top corporate priority and is to be treated by the whole organization with the same sense of urgency and importance “ as a ‘Level 3’ emergency —Anthony Lake, UNICEF Executive Director 2 © UNICEF Pakistan/2012/Khan
INTRODUCTION I n May 2012, the World Health Assembly formally declared polio eradication as a “programmatic emergency for UNICEF is one of the leading partners in the GPEI along with the World Health Organization, Centers for Disease Control global public health” and called for and Prevention, Rotary International and the development and finalization of a the Bill and Melinda Gates Foundation. comprehensive polio endgame strategy. Within the polio partnership, UNICEF is Efforts towards eradication involve many the lead agency for two specific areas: different actors at country, regional and 1. Communication and social global levels. At the centre of this effort mobilization and is the Global Polio Eradication Initiative 2. Vaccine supply, which includes (GPEI), which was established in 1988 procurement, effective vaccine when there were an estimated 350,000 management (VM) and cold chain polio cases reported from 125 endemic logistics (CCL) countries. Considerable progress towards global polio eradication has UNICEF’s role in vaccine supply includes since been made, and by September providing technical support to national 2015 only two countries continue to have governments, local authorities and endemic transmission of wild polio virus: partners to: Afghanistan and Pakistan. However, due 1. Forecast, procure and deliver vaccines to significant gaps in immunity and high and cold chain equipment population movements, several polio- 2. Manage in-country vaccine free countries were either re-infected, stocks, including effective vaccine causing large outbreaks with extensive management up to the point of service transmission, or remain at risk. delivery, and 3. Maintain cold chain equipment (CCE) and strengthen logistics services 3
Purpose of a guidance note on CCL&VM in polio SIAs © UNICEF Pakistan/2012/W.Niaz A s a leading agency in supporting immunization supply chain systems, UNICEF is expected within the GPEI to provide UNICEF staff and consultants at global, regional and country levels as well as GPEI partners with a framework play a key role in supply chain, which to guide and strengthen their role in includes procurement and delivery of implementing cold chain logistics and vaccines to countries procuring through vaccine management activities, focusing UNICEF, as well as in-country cold chain, on country-level activities. vaccine management and logistics support. While procurement and supplies Countries either manage their own to country level are managed by UNICEF procurement and supply of vaccines (at Supply Division (SD) at the global level, country or regional level) or depend on UNICEF Country Offices (CO) supported UNICEF-SD to do so. While this guidance by UNICEF Regional Offices and note focuses on UNICEF vaccine supply Programme Division (PD) have a more management, many of the principles direct role to play in supporting national outlined here can also be adapted by immunization programmes in planning other partner agencies and by country and managing their vaccine supplies programmes that procure and manage in-country. This guidance note aims to their vaccines directly. 4
Scope of this guidance note T his guidance note focuses on cold chain logistics and vaccine management (CCL&VM) activities to be conducting SIA rounds with Inactivated Polio Vaccine (IPV) in special situations. Implementing IPV SIAs poses a different implemented before, during and after set of operational and communication polio SIAs, and will help to: challenges from those encountered Explain the expected roles and in OPV or measles SIAs. While this responsibilities for UNICEF staff/ guidance note does not attempt to serve consultants to ensure that appropriate as detailed operational guidelines for CCL&VM systems and mechanisms IPV SIAs, we include a brief section on are in place at different levels before, this area and provide a comparison of during and after a polio SIA some of the operational (logistics) and Outline the processes, tools and communication issues that programme indicators available to support managers may need to consider before these efforts conducting an SIA round with OPV, IPV or measles vaccine (Table 1) Most countries in the world have experience in implementing mass This guidance note may also be useful immunization campaigns (supplementary to any other staff working on cold chain immunization activities or SIAs) with and logistics. It is not expected, however, oral polio vaccines (OPV), and some that this guidance note will cover all also have experience in implementing the details related to cold chain and measles and tetanus SIAs. While most logistics during polio SIAs. For additional references in this guidance note pertain information, relevant links and resources to using OPV in SIAs, as per GPEI are included at the end of the document. guidance, the endemic countries are also 5
TABLE 1 OPV, measles and IPV campaigns: Key differences in technical, operational and communication domains PARAMETER ORAL POLIO VACCINE MEASLES VACCINE INACTIVATED POLIO (OPV) CAMPAIGNS* CAMPAIGNS VACCINE (IPV) CAMPAIGNS Operational Most countries have Many countries have Very limited to no experience extensive experience experience experience at country level Target population Target population usually Target population variable: As per GPEI 0–59 months (may Usually lower limit is 6 or 9 recommendations be modified by local months and upper limit is suitably adapted to epidemiological situation/ 5, 10 or 15 years local epidemiology and outbreak response) national/regional TAG recommendations Duration of SIA Usually completed in a few May extend over 3–4 May extend over 3–4 days to a week weeks weeks Route of Oral Sub-cutaneous (SC) Intra-muscular (IM) or SC administration of injection. injection vaccine Also effective by intra- muscular (IM) route Storage Vaccine vials can be Injectable vaccine with Injectable liquid requirement stored until expiry date diluent for reconstitution: vaccine. Damaged by and precautions (usually 2 years) at −20 Freeze-dried vaccine freezing. Occupies same during transit Degrees or at +2 to +8 can be stored at +2 compartment as other Degrees Celsius for a to +8 Degree Celsius. vaccines used in routine maximum of 6 months. Diluent stored at same immunization (+2 to +8 During shipment or in temperature at least 24 Degree Celsius) and may the field, vaccine may be hours before use and must pose storage constraints thawed and refrozen. not be frozen in IPV-OPV campaigns. Special precautions needed to ensure vaccines are not frozen during transit. Bundling and Supply with droppers Supply with Supply with sterile supply to service manufacturer’s diluent, syringe/needles for delivery points sterile syringe/needle administration for reconstitution and administration Use of opened Opened vials can be re- Reconstituted vaccine: Opened vials can be re- multi-dose vials used for up to 28 days as Discard after 6 hours or used for up to 28 days as per criteria laid down in end of session, whichever per criteria laid down in WHO MDVP policy. is earlier WHO MDVP policy. Continued > 6
TABLE 1 OPV, measles and IPV campaigns: Key differences in technical, (CONTINUED) operational and communication domains PARAMETER ORAL POLIO VACCINE MEASLES VACCINE INACTIVATED POLIO (OPV) CAMPAIGNS* CAMPAIGNS VACCINE (IPV) CAMPAIGNS Vaccine wastage 5–15% on average 10–15% depending on vial Limited IPV SIA data rate size available suggests
CCL&VM in the context of the Polio Eradication and Endgame Strategic Plan (PEESP) © Polio UNICEF/India/2015/Akaur T he Polio Eradication and Endgame Strategic Plan 2013–2018 was developed by the GPEI with inputs from Supplementary immunization activities (SIAs) remain a key operational strategy for rapidly improving population national health authorities, scientific immunity against poliovirus in endemic, experts and partners. The plan has four outbreak affected and at risk countries. major objectives: Gains in population immunity made 1. Poliovirus detection and interruption through SIAs can be sustained through of poliovirus transmission high routine immunization coverage. 2. Routine immunization strengthening, oral polio vaccine withdrawal and IPV Well-planned and implemented vaccine introduction in routine immunization supply and management activities that 3. Laboratory containment and polio-free ensure adequate quantity and quality certification of vaccine and supplies for polio SIAs 4. Legacy planning can also strengthen CCL&VM systems for both routine immunization and other non-polio SIAs. For example, the use of polio SIA micro-plans and vaccine distribution plans as well as staff training 8
on vaccine management in preparation At the global level, GPEI, through several for SIAs can directly improve routine of its working groups and task teams immunization and remain a legacy of the (e.g. Risk Assessment Task Team, SIA polio eradication programme. Options Task Team, Vaccine Supply Task Team etc.), as well as regional Additionally, installation of new cold and country teams, undertakes a chain equipment to accommodate the rigorous process of risk assessment to surge in supplies for polio SIAs, as well develop and approve a global GPEI SIA as improvements in vaccine utilization calendar on a six-monthly to annual and safety management anticipated basis. This process takes into account during the withdrawal of trivalent oral updated epidemiological information, polio vaccine (tOPV) and introduction mathematical modelling for immunity, of inactivated polio vaccine (IPV) on a surveillance information, historical globally unprecedented scale, will be experience, supply availability and another opportunity for polio eradication other factors to come up with a number to have a positive impact on routine of alternate options for the global immunization. SIA calendar. With additional inputs on available finances from Finance Strengthening vaccine management Management Team (FMT), the alternate and logistics systems for polio SIAs scenarios are then presented to the is one of several ways that the polio Eradication and Outbreak Management eradication program can benefit routine Group (EOMG). Finally, EOMG and immunization systems. (Abdelwahab, Strategy Committee (SC) review the Jalaa’, et al., 2014). Robust vaccine proposed options and a decision is made stock management systems necessary on the final calendar. for handling large volumes of vaccine in polio SIAs also strengthen vaccine The global GPEI SIA calendar specifies management systems in routine the number of SIA to be implemented by immunization. In some countries (e.g. country by month, the proportion of its Pakistan) polio social mobilization staff population to be targeted and the type (COMNet) have supported making of vaccine (tOPV or bOPV) to be used. inventories of functional cold chain The initial projections are reviewed and equipment. revised in the event of outbreaks and as per other changing epidemiological Finally, the magnitude of annual vaccine needs including isolation of wild as well procurement and utilization by GPEI (in as vaccine derived polioviruses. From 2014 UNICEF delivered 1.7 billion doses the logistics perspective, this is a critical of OPV, worth USD 272 million) and the planning tool to ensure timely supply of urgency for achieving polio eradication vaccines to all countries. have further underscored the need to rapidly develop clear guidelines and tools For countries which procure their polio for improving vaccine management in the SIA vaccines through UNICEF, UNICEF context of polio SIAs. SD supports implementation of the approved global SIA calendar by issuing global tenders in accordance with 9
public procurement practices to meet organizational objectives and achieve best value for money. Historically, OPV supply has been constrained and there has been a need to balance supply and demand taking into consideration all planned activities against projected and actual availability of vaccines from the manufacturers producing WHO prequalified vaccines. Overview Managing supply lines is a dynamic process closely coordinated by UNICEF with performance indicators regularly of CCL&VM reviewed by the programme including by the Polio Oversight board (POB). This includes maintaining a dynamic buffer systems in stock of at least 30-40 million doses of each type of oral polio vaccine (tOPV and bOPV) at the global level. The vaccine polio SIAs product by a particular manufacturer has to be approved by the country’s national regulatory authority (NRA) before it can be supplied to the country. Occasionally, in the interest of program implementation, countries have issued regulatory waivers for WHO pre-qualified vaccines supplied by UNICEF. As global supplies of polio vaccines O nce vaccine stocks are received in a country, it is extremely important that the vaccine be stored, distributed for UNICEF are limited and draw upon and used optimally, maintaining proper manufacturing capacities of WHO pre- cold chain temperatures. The data for qualified manufacturers, in-country in-country vaccine utilization and stock vaccine wastage has to be minimized balances at national as well as sub- and demands for fresh vaccine supplies national levels should be recorded and adjusted against available stock balances communicated accurately, completely within countries. A global standard and in a timely way to national, regional operating procedure for vaccine and global levels. management (SOP-VM) to report on vaccine utilization has been designed A robust vaccine cold chain and (Annex 2). The May 2015 report of the logistics system including storage and International Monitoring Board (IMB) of transportation is the cornerstone of all GPEI has recommended that polio priority in-country immunization programmes. countries should apply the SOP-VM to Rigorous supply planning based on optimize vaccine utilization (IMB, 2015). accurate data should enable such a 10
© UNICEF DRC/2012/Petit system to have the right vaccines in the quantities of vaccine within a short period right place, at the right time, in the right of time, which may involve various quantities, in the right condition, and at delivery strategies beyond those typically the right cost (Wisner, 2012). used for routine immunization. This may require additional surge capacities By and large, many components of in storage, management and supply in-country supply and cold chain of vaccines from proximal to distal infrastructure for routine immunization levels and in retrieving, accounting and are the same as those being used managing stocks at the end of an SIA for implementation of polio SIAs. round. Innovative strategies like cross- However, the forecasting, funding, docking1 have been utilized in polio procurement and cold chain and logistics SIAs to cope with capacity constraints in requirements at all levels are at a larger proximal level stores. scale during polio SIAs than in routine immunization programme. 1 Cross-docking: A continuous replenishment logistics process SIA campaigns involve the arrival, at a distribution centre, where incoming goods are sorted and/ or consolidated, and then shipped out to their final destinations, distribution, storage and use of large without the need to store the goods. 11
Figure 1 is a schematic diagram depicting At the end of an SIA round, proper flow of vaccines and other ancillary inventory management and storage equipment (bundling), as well as flow of and/or reverse shipment of unutilized information between different levels of vaccine and information transfer the vaccine logistics chain. Both vaccine regarding stock utilization and stocks and inventory information must balances be in the forward flow loop, whereas it is equally important that inventory Data needed for CCL&VM are often information (balance stocks, utilization available at the peripheral level and reports etc.) flow backward in the reverse collected along with operational data loop with or without remaining vaccine such as number of children vaccinated. stocks. The reverse flow loop for vaccine With the support of both WHO and inventory information is often a weak link UNICEF, local programmes should in country supply chains. be able to ensure and streamline the collection, submission and use of this Effective and efficient vaccine information. management for SIAs includes: Planning, procuring, storing and For SIAs, the cold chain logistics and supplying (to and from each level of vaccine management activities can be the supply chain) appropriate and fully divided into three phases: pre-campaign, potent vaccines in right quantities intra-campaign and post-campaign. down to the service delivery levels There are specific tasks, requirements Ensuring that vaccine supplied and indicators (see Annexes) at national, is properly administered and regional and global levels for each phase accounted for with appropriate record of the campaign. Country immunization maintenance at all levels programmes should have well-laid- Reverse cold chain for stool shipment in surveillance Stool samples from acute flaccid paralysis (AFP) cases should be transported to the laboratory for virus isolation under cold chain temperature conditions similar to vaccines in order to keep any potential polio virus viable. This is referred to as ‘reverse cold chain’. Ideally, only specimen carriers kept aside for this purpose should be used for these shipments. Sometimes, when such specimen carriers are not available, vaccine carriers can be used for this purpose. However, a vaccine carrier, once used for transport of stool specimens, should never again be used to store or transport vaccines. The materials and equipment used to transport stool specimens for poliovirus isolation can become contaminated with the virus. Therefore these materials should be destroyed or disinfected after each use and clearly marked out and segregated from other equipment used for vaccine storage and transport. Vaccine carriers should not be used to ship biological specimens nationally or internationally by air (WHO, 2004). 12
Figure 1: Bundled vaccines and vaccination equipment* as well as information for inventory control must flow up and down the logistics chain GLOBAL SUPPLIES (e.g. UNICEF-SD) NATIONAL STORE PROVINCIAL STORE DISTRICT STORE ONWARD FLOW: BUNDLED VACCINES + INFORMATION SERVICE REVERSE FLOW: DELIVERY INFORMATION +/- BUNDLED POINTS VACCINES * e.g. droppers, auto-disable syringes, safety-boxes etc. out policies regarding both onward The data generated and compiled on and reverse shipment and utilization of CCL&VM are critical to guide programme vaccines before, during and after SIAs. management as well as advocacy efforts by UNICEF and the GPEI in discussions It is also important to ensure that other with community members, local partners equipment/materials needed for quality and authorities as well as governments campaign activity and post-campaign and external partners, to ensure that gaps monitoring (PCM), such as finger markers are well identified and addressed in a etc., are adequately planned. Ensuring timely manner. good PCM is essential if we are to be sure that campaigns have been properly Strengthening in-country vaccine carried out. logistics and management for polio SIAs would also likely have a positive impact on the overall vaccine management for the routine immunization programme. 13
Common challenges observed in CCL&VM in polio SIAs A ssessments made during SIAs in polio priority countries have highlighted some of the challenges storage and management. Often financing is inadequate to address these deficits. in cold chain logistics and vaccine Data on vaccine stocks, distribution management systems: and utilization are not regularly Significant differences exist in collected, updated and analysed in the operational target for SIAs order to rationalize vaccine supplies (denominator) and official population and avoid stock-outs or overstock. figures at country level which can Even when an SIA round has been create difficulties in determining agreed upon in the global SIA calendar the precise target populations and of the GPEI, and supply quantities immunization coverage. secured with manufacturers, countries Cold chain equipment: There are need to communicate vaccine supply absolute or relative deficiencies (due requirements to UNICEF-SD early to maldistribution) in cold chain enough, taking into account shipment equipment needed to cater to the large lead times: population targeted in an SIA, causing Vaccines are shipped by UNICEF- problems in vaccine distribution, SD to countries by air. The 14
approximately 3–4 months. In some circumstances, either due to faulty training, logistical and operational challenges, or inefficient vaccine management practices, vaccine wastage rates have been observed to be substantially higher than the expected rate of 5–15 per cent for OPV. Conversely, vaccine wastage may be unrealistically low owing to reporting errors in numerator (e.g. children vaccinated reported higher than actual) or denominator (e.g. reported vaccine doses utilized lower than actual) and other data quality issues. Micro-plans are not updated regularly to adequately reflect status and gaps in cold chain equipment or vaccine storage capacity, especially at the peripheral level. Preparing micro- plans for a polio SIA is an excellent opportunity to identify and update gaps and advocate for corrective © UNICEF measures through the various existing polio structures. Distribution plans (for both onward vaccines are made ready for and reverse flow) for vaccines are not dispatch within approximately always laid out explicitly and clearly. 2–3 weeks from placement of Vaccination teams are often not the purchase order with the managed and coordinated well supplier, and then a further during campaigns to ensure real-time 1–3 weeks are needed to make redistribution of vaccines and supplies the necessary arrangements as needed. for shipment by air. Once air Significant differences remain between shipment starts, according to the vaccine doses required per the WHO guidelines, the consignment updated micro-plan and distribution should not take longer than 48 plans and the requested and final hours to reach final destination number of doses administered. while maintaining approved Human resources for CCL&VM temperature range (WHO, 2005a). positions at various levels either Immunization devices, on the are vacant, or filled positions are other hand, are shipped by not provided regular training and sea owing to their bulkiness, supervision, particularly at provincial/ with a shipment lead time of regional or district stores. 15
Points to keep in mind in SIA vaccine management ÎÎ Vaccines are expensive. Detailed written All such alternative supply routes should plans for delivery and distribution of be included in the distribution plan and not bundled vaccines should be developed for done in an ad-hoc manner. every level. ÎÎ Alternately, if a proximal level store has no ÎÎ Bundled vaccine movement through the constraints in vaccine storage space but a logistics system during an SIA is several distal level store has space constraints, the times the annual routine immunization proximal (larger) store may supply the distal requirement (for all vaccines) in a very short store in smaller but more frequent shipments period and may quickly overwhelm logistics before and during the SIA. management systems if not planned properly. ÎÎ Managing vaccine utilization and stocks ÎÎ During SIAs, proximal level stores often have properly before, during and after SIAs is space constraints for vaccine storage, while important. Post-SIA vaccine inventory distal level stores often face challenges in management is often neglected. Detailed preparing larger numbers of ice packs in a plans should be made and policies laid out short period. for return and use of opened vials as per the ÎÎ If proximal level stores lack adequate WHO multi-dose vial policy (MDVP). space to accommodate larger quantities of ÎÎ Vaccine wastage at the service delivery vaccines required for SIA, alternate stores level is expected to be less in SIAs (as and supply routes should be planned for compared to routine immunization). (Figure 2). ÎÎ Vaccine waste generated during SIAs ÎÎ Vaccines and supplies may be delivered should be properly managed according to directly to distal stores, bypassing proximal global guidelines and national regulations stores with space constraints during SIAs. in place. 16
Figure 2: Schematic diagram for usual (same as in routine immunization) and alternate vaccine delivery plans during SIAs SUB-DISTRICT/SERVICE DELIVERY LEVEL DISTRICT STORE SUB-DISTRICT/SERVICE DELIVERY LEVEL STATE STORE SUB-DISTRICT/SERVICE CENTRAL DISTRICT DELIVERY LEVEL STORE STORE SUB- DISTRICT/ STATE DISTRICT SERVICE STORE STORE DELIVERY LEVEL REGIONAL STORE VACCINE DELIVERY PLANS FOR ROUTINE SUB- IMMUNIZATION DISTRICT DISTRICT/ STORE SERVICE ALTERNATE VACCINE DELIVERY DELIVERY PLANS LEVEL FOR SIAS STORE WITH STORE ADEQUATE WITH SPACE CAPACITY CONSTRAINT 17 © WHO/2011/T.Moran
Vaccine usage, wastage and multi-dose vial policy (MDVP) © TempTime O ptimal vaccine management entails maximizing coverage through high vaccine usage while minimizing wastage. Vaccine wastage rate (%) can be considered as 100 − Vaccine usage rate. Vaccine wastage can occur in both It is convenient to consider vaccine usage opened as well as unopened vials. Some first to understand vaccine wastage. examples are cited in Table 2. Vaccine usage rate has been defined as below (WHO, 2005b): VACCINE USAGE RATE (%) Number of doses correctly administered Vaccine usage rate (%) = x 100 Number of doses issued TABLE 2 Examples of vaccine wastage* Vaccine wastage in unopened vials Vaccine wastage in opened vials ÎÎ Expiry In addition to the types listed in the previous ÎÎ VVM indication column: ÎÎ Heat exposure ÎÎ Discarding remaining doses at end of day’s SIA activity (e.g. not applying multi-dose vial ÎÎ Freezing (e.g. IPV) policy for opened vials) ÎÎ Breakage ÎÎ Not being able to administer the number of ÎÎ Missing inventory doses indicated on the label of the vial ÎÎ Theft ÎÎ Submergence of opened vials in water ÎÎ Discarding unused vials returned at end of damaging the labels day’s SIA activity ÎÎ Suspected contamination *Adapted from World Health Organization, Monitoring Vaccine Wastage at Country Level: Guidelines for programme managers, WHO, Geneva, 2005. 18
While vaccine wastage in stores should While calculating vaccine requirements be kept at a minimum (less than 1 per for an SIA target population taking cent), a higher wastage level may have wastage into account, it is necessary to be accepted at service delivery level. to multiply the target population Operationally, at service delivery level, with a Wastage Factor or a Wastage it is convenient to calculate vaccine Multiplication Factor (WMF). wastage in an SIA round by the following formula: VACCINE WASTAGE RATE (%) Number of doses used -Children immunized Vaccine wastage rate (%) = × 100 Number of doses used where, ‘Number of doses used’ includes doses used for immunization and all doses discarded or lost for any reason (including expiry, VVM indication, cold chain failure, freezing, missing inventory or routine discard of open vials of vaccine at the end of a session or campaign activity). WASTAGE FACTOR (WF) OR WASTAGE MULTIPLICATION FACTOR (WMF) 100 WMF= 100-Vaccine wastage rate Note that WMF is a number and not a percentage. Vaccine requirement calculations Since for planning purposes the target and buffer quantity coverage is usually 100 per cent (or 1 as a Based on target population, the formula proportion), the formula works out to be to calculate vaccine requirement for one a simple product of target population and round of polio SIA is the product of target WMF. population, WMF and target coverage. TABLE 3 Wastage rate, wastage multiplication factor and vaccine requirement Vaccine doses required for Wastage rate (%) WMF a target population of 1,000 (rounded) 5% 1.05 1,050 10% 1.11 1,110 15% 1.18 1,180 19
VACCINE REQUIREMENT FOR ONE ROUND OF SIA WITH TARGET COVERAGE OF 100% Vaccine requirement (doses)=Target population × WMF Unlike in routine immunization, no For WHO pre-qualified vaccines procured buffer quantity is usually added to this by UNICEF, WHO published a revision of calculated vaccine requirement for an its multi-dose vial policy (MDVP) in 2014, SIA round for most countries. However, allowing use of multi-dose vials up to 28 for endemic countries a buffer quantity days after opening the vial provided the is added to the estimated annual SIA following criteria are met (WHO, 2014): requirement. This buffer quantity usually 1. The vaccine is currently prequalified refers to vaccine quantities that are by WHO above what is detailed and requested 2. The vaccine is approved for use for the planned SIAs and other regular for up to 28 days after opening the immunization activities (including transit vial, as determined by WHO and as point strategy, International Health published on its website that cannot be planned and forecast in 3. The expiry date of the vaccine has not advance such as case response rounds passed and mop-up activities, and it is usually 4. The vaccine vial has been, and will based on previous country specific continue to be, stored at WHO- experience in the polio eradication or manufacturer- recommended programme. temperatures; furthermore, the vaccine vial monitor, if one is attached, Some useful norms for logistics is visible on the vaccine label and calculations are included in Table 4. is not past its discard point, and the vaccine has not been damaged by While multi-dose vials save on cost per freezing dose and storage space, they also lead to some degree of unavoidable operational As noted above, when all these criteria wastage of unutilized vaccine doses in are fulfilled, opened vials of WHO pre- opened vials. For OPV, wastage at service qualified OPV may be used for up to 28 delivery level in SIAs usually ranges days after opening. This practice can between 5–15 per cent and tends to be reduce vaccine wastage in opened vials lower than in a routine immunization significantly. At the service delivery level, setting. For further details on calculating health workers should be trained to note different kinds of vaccine wastage the the date and time of opening of vials to reader is referred to reference cited above enable application of MDVP. (WHO 2005b). 20
TABLE 4 Useful norms for calculating vaccine and other logistics requirements for OPV and IPV campaigns* Activity / Unit Norm Vaccine wastage (Number of doses used − Number of children immunized) ×100 / (Number rate (%) of doses used), where , ‘Number of doses used’ includes doses used for immunization and all doses discarded or lost for any reason (including expiry, VVM indication, missing inventory, cold chain failure, freezing, or discarding of open vials of vaccine at the end of a session or campaign activity). Wastage 100/(100 − Vaccine wastage rate ) Multiplication Factor (WMF) Vaccine doses Target population × WMF × Target coverage required for one round of SIA For SIAs Target coverage is usually 100% Vaccine vials (and Vaccine doses required / vial size; Number of droppers for OPV = number of droppers) required vials. Auto disable Target population × WMF for ADS syringes (ADS) required For service delivery points, ADS = Vaccine doses supplied Safety boxes (5 ltr) (Number of AD Syringes)/100 or at least one per session site (whichever is required (for IPV) greater) Vaccine storage IPV: 10-dose vial – 2.5 cubic centimetre/dose (cc/dose) space 5 dose vial − 4.0 cc/dose OPV: 10-dose vial – 2.0 cc/dose 20-dose vial – 1.0 cc/dose Cold chain space Varies according to country immunization schedule. Each country should required for routine calculate this in cubic centimetres (cc) per child and mother for all vaccines to immunization (RI) be given in one year and derive volume requirements as per supply periodicity and buffer requirement for supply chain level. While calculating SIA cold chain requirement, cold chain space for RI vaccines should first be set aside. Indelible ink marker 1 pen per 300 children or at least 1 per session site (whichever is greater). Higher pens for OPV-IPV or other combined campaigns needing >1 finger mark per child. *The norms mentioned here are generic. Actual figures may vary according to national policies or local context. Note: Dry storage for droppers and/or syringes should be calculated separately. Additional information on vaccine storage and ice pack freezing capacities can be downloaded at . 21
IPV campaigns O bjective 2 of PEESP has the target of introducing at least 1 dose of IPV in routine immunization (RI) in all their serologic and gut immunity to polioviruses helping to interrupt transmission. Recent studies have shown countries that do not currently use IPV that, especially in settings where OPV is in RI. This will be a major global new less immunogenic, a supplemental dose vaccine introduction in the context of of IPV can close the immunity gap more strengthening routine immunization. effectively than another dose of OPV. Despite repeated SIAs with oral polio Although IPV requires skilled personnel vaccines, wild poliovirus transmission to administer the vaccine at fixed sites, as has persisted in some of the reservoir opposed to a house-to-house approach, areas of endemic countries. Evidence it lends itself well to being integrated from serological studies (Estívariz, into polio plus or integrated child health Concepción, et al., 2012; Moriniere, day activities such as health camps, Bernard J., et al., 1993; John, T. Jacob, permanent transit points and other SIAs et al., 2014) shows that IPV administered with injectable vaccines (e.g. measles and to persons who have previously tetanus campaigns). Unlike OPV, IPV is received OPV can significantly boost damaged by freezing and combined IPV- 22
� UNICEF/NYHQ2012-2216/Markisz OPV campaigns should maintain proper Further detailed guidance on IPV SIAs is cold chain for both vaccines. available at . experience in conducting OPV campaigns and some experience in measles Other IPV-related technical material also campaigns, very few countries have available at . Combined IPV+OPV SIAs have been recently used by the programme with a more focused and targeted scope to rapidly build population immunity and interrupt poliovirus transmission in areas with persistent circulation (despite high quality SIAs with OPV) or limited windows of opportunity for access. 23
© UNICEF/NYHQ2010-0783/Liu Monitoring performance on CCL&VM for polio SIAs © WHO/2011/T.Moran E fforts to strengthen oversight and accountability in vaccine supply for polio SIAs have resulted in the has also developed polio management dashboard indicators which are primarily used in endemic and polio priority development of specific indicators (e.g. countries to monitor progress on vaccine the Polio Oversight Board indicators) to availability, vaccine wastage, utilization, monitor the availability of vaccine and stock reporting and cold chain capacity. the ability to respond to unexpected increases in demand by maintaining a Table 6 includes a list of key indicators notional buffer level of vaccine stock at that are being used by UNICEF senior the global level (Table 5). management to monitor SIA performance on CCL&VM in endemic countries. Comparable monitoring activities and indicators have not always been Table 7 lists some additional indicators available or implemented at country which may be adapted by country level. Consequently, indicators have programmes for monitoring performance been added to national emergency action on CCL&VM in polio SIAs. plans and polio monitoring cells. UNICEF 24
Annex 1 has a list of additional activities, processes, expected results and indicators which can be used at country, regional and global levels for detailed performance monitoring before, during and after polio SIA campaigns (Table 8, Table 9 and Table 10). TABLE 5 Polio Oversight Board (POB) indicators on CCL&VM: measured on a quarterly basis and reviewed at the global level INDICATOR DEFINITION TARGET SOURCE Proportion of planned* SIAs Numerator is the number
TABLE 6 UNICEF management dashboard indicators for programme monitoring CCL&VM in SIA in endemic countries INDICATOR DEFINITION (FOR ENDEMIC COUNTRIES)2 TARGET SOURCE Delays in OPV Percentage of High Risk Districts (HRD) out of total 0% Polio control supply HRD, that did NOT receive polio vaccine supply room/EPI Cell/ at least 3 days before the planned starting date of Emergency campaign Operations Centre Stock reporting Percentage of High Risk Districts out of total HRD, >=80% Polio control which reported on balance of SIA vaccine stocks room/EPI Cell/EOC after last SIA round OPV wastage rate Percentage of High Risk Districts out of total HRD >90% Summary tally where OPV wastage rate in SIAs is between 5% sheet data and 15% Cold chain Percentage of High Risk districts out of total HRD >90% Micro-plan data functional status where at least 90% of active (e.g. electric, solar, or other Cold kerosene) cold chain equipment are functional Chain Equipment (maintaining optimal temperature range) assessment 2 The definitions given here are generic for endemic countries. Precise definitions of UNICEF dashboard indicators are adapted to country context for some endemic countries and for outbreak countries. 26
Additional indicators for monitoring CCL&VM performance in polio TABLE 7 SIAs at sub-national level INDICATOR DEFINITION (MAY BE ADAPTED TO TARGET SOURCE COUNTRY CONTEXT) Percentage of micro-plans with Micro-plans with updated CCL&VM, >=80% Micro-plans CCL&VM, CCE and transportation CCE and transportation components/ component updated total number of micro-plans Percentage of subnational and Sites with an updated vaccine >90% Micro-plans peripheral sites with an updated distribution plan/total number of sites vaccine distribution plan with vaccine distribution plans Percentage of stores at the Stores that received appropriate 100% Micro-plans/ subnational and peripheral levels amount of vaccine in good quality (VVM vaccine that received appropriate amount at usable stage) in a timely manner per store of vaccine in good quality (VVM at the micro-plan/total number of stores records usable stage) in a timely manner that were expected to receive vaccine as per the micro-plan as per the micro-plan Percentage of vaccine store Vaccine store records updated by >=80% Micro-plans/ records updated by vaccine type vaccine type and segregated by RI vaccine (bOPV, tOPV, IPV), segregated by and SIA/total number of vaccine store store RI and SIA records records Percentage of sites by sub- Sites with unused vaccine that is >=80% Vaccine national administrative level returned to vaccine stores at the end store with unused vaccine returned to of the campaign as per national policy records vaccine stores at the end of the /total number of sites with unused campaign as per national policy vaccine at the end of the campaign Percentage of supervisors and Supervisors and teams trained >=90% Campaign teams trained (including handling of vaccine and monitoring understanding VVM) before the campaign/total number of supervisors and teams monitored Percentage of sub-national level Stores / teams with stock-out during 0% Campaign stores / teams with stock-out of polio SIA divided by total number of monitoring vaccine impacting activity stores / teams (or teams monitored) or SIA data Percentage of teams using a vial Number of teams using a vial with 0% Campaign with VVM in unusable stage VVM in unusable stage/total number of monitoring teams monitored 27
Standard Operating Procedures for SIA polio vaccine management (SOP-VM) © UNICEF/UNI183367/Bindra I n its 9th report the IMB had noted the importance of stringent vaccine management and reporting on balance In order to initiate a standardized process of collecting this information, UNICEF had worked with GPEI partners in the vaccine stocks by countries for better vaccine supply task team to develop a management of global vaccine supplies. standard operating procedure for vaccine Capturing vaccine utilization data as management incorporating two simple well as stock balances for vaccines data collection tools. This was circulated used in polio SIAs is a challenge for by GPEI in early 2015. both GPEI and country programmes. However, such information is essential Taking a cue from the 9th IMB report, to rationalize vaccine supplies within countries of the UNICEF Western and the country as well as globally. It is Central Africa Region had applied the especially important to capture such SOP-VM, which helped reduce oral polio information from the endemic countries vaccine demand by 2.5 million doses because of the large quantities of polio over two months across nine countries vaccines being used there. (IMB, 2015). 28
“ SIMPLE DROPS OF VACCINE Vaccine is precious, and there is considerable scope for countries, supported by partners, to further improve its judicious management. The IMB recommends that in the endemic and priority countries, vaccine wastage be urgently reduced to 15% as an absolute maximum in every subnational area, starting by full implementation of the programme’s standard operating procedure for “ reporting on vaccine utilization and stock balance. — 11th report of International Monitoring Board of GPEI (May 2015) th The current version of the SOP and tools In its 11 report (May 2015) the IMB are included in Annex 2. Based on the has recommended applying the SOP- SOP-VM it is expected that endemic VM to monitor vaccine utilization at countries will be submitting the vaccine national as well as sub-national levels stock reports along with new vaccine in endemic and polio priority countries. supply requests. Similarly, endemic The current version of SOP-VM and the countries are expected to provide a tools will therefore be updated to help monthly update on vaccine utilization support countries to capture, analyse based on implemented activities to and report data on vaccine utilization UNICEF Programme Division for analysis from sub-national levels for optimizing and feedback. vaccine usage. While endemic countries are being In October 2015, the Strategic prioritized for using these tools, all Advisory Group of Experts (SAGE) has country programmes implementing polio recommended implementing the global SIAs are encouraged to make use of switch from tOPV to bOPV in April 2016. them with support from their respective Application of the SOP-VM to monitor regional offices. Electronic vaccine stock levels of tOPV will be of critical logistics systems will facilitate capturing importance for a successful ‘switch’. such information. 29
Roles and responsibilities in supporting CCL&VM activities for polio SIA S uccessful CCL&VM requires the efforts of teams at all levels; however, members of the national working groups or similar functional groups are critical for the management of vaccine stocks for SIAs as well as the operational team are particularly distribution, utilization and oversight important for monitoring progress, for SIA vaccine management data at all identifying gaps and instituting corrective levels. As we move closer towards global measures. Coordination committees at polio eradication and implementation of national, provincial and peripheral levels the GPEI PEESP, ensuring high quality, as well as technical working groups are functioning logistics working groups vital in this process. will become even more important in supporting the surge in cold chain and National immunization programmes logistics activities related to the oral often set up logistics working groups polio vaccine switch from trivalent OPV to provide operational guidance and (tOPV) to bivalent OPV (bOPV), avoiding technical support for the overall cold overstocking of tOPV and initial supplies chain and logistics system for the of bOPV, integrating inactivated polio Expanded Program on Immunization vaccine into routine immunization, and (EPI) and are also particularly important improving vaccine safety and waste during SIAs. Specifically, logistics management. 30
CONCLUSION © POLIO ERADICATION - UNICEF SNID T o ensure that the world achieves and sustains polio eradication through global certification, country programmes We hope the overall guidance regarding processes, activities and indicators provided in this note will help improve must implement high quality SIAs, cold chain logistics and vaccine maintaining integrity of the cold chain management at global, regional and throughout the logistics cycle. country levels. The projected global SIA schedule for countries needs to be coordinated well in advance so that global manufacturing, procurement and supply of polio vaccines to countries can support successful implementation of the planned polio SIAs. At the service delivery level, in- country vaccine management should ensure optimal use of polio vaccines and efficient use of resources. 31
ANNEXES 32 © UNICEF Pakistan/2012/W.Niaz
Annex 1: Key activities, processes, results and indicators for CCL&VM performance in polio SIAs at national, regional and global levels The following tables (8 - 10) set out generic timelines and lists of key activities that should be completed before, during and after SIA campaigns. Country programmes need to adapt these timelines and activities to their specific contexts. Note that these timelines do not apply to polio outbreak situations where many activities will have to be completed within a shorter timeframe as per global Standard Operating Procedures for polio outbreaks. National level: Key activities, processes, results and indicators for TABLE 8 CCL&VM before, during and after polio SIA rounds National level: Pre-campaign (completed 8–12 weeks before the start of the campaign) KEY ACTIVITY PROCESS EXPECTED RESULT INDICATOR Estimate Start planning with appropriate Adequate quantity Percentage of states/ and order type of vaccine, target age group of vaccine and other districts where a the quantity and percentage of population ancillary materials planned and approved of OPV and to be covered by reviewing available in country in SIA campaign was other related Technical Advisory Group (TAG) a timely manner cancelled, postponed supplies recommendations and global SIA or delayed because calendar. of delayed vaccine supply. Communicate any discrepancy between the global SIA calendar (Target: 0%) and country plans to WHO and UNICEF regional offices along with background and justification for changes. Estimate target population size from various sources (e.g. recent census data, population estimates and previous campaigns coverage) and the vaccine doses required. Inventory: Review in-country balance stock of vaccines and adjust vaccine demand accordingly. Present the planned and needed vaccine requirements to the Vaccine Management/Logistics committee and get endorsement by Government, WHO/GPEI and other partners as needed to secure supplies. Continued > 33
TABLE 8 National level: Key activities, processes, results and indicators for (CONTINUED) CCL&VM before, during and after polio SIA rounds National level: Pre-campaign (completed 8–12 weeks before the start of the campaign) KEY ACTIVITY PROCESS EXPECTED RESULT INDICATOR Submit request of official estimated needs of vaccine along with the reports on vaccine stock and utilization to UNICEF-Supply Division, copying UNICEF Programme Division as per SOP-VM. Review vaccine type for registration and licensing requirements, which could impact vaccine availability. Coordinate with the National Regulatory Authority and WHO for expediting waivers for importation, if needed. Review CCL, Review CCL and CCE resource and CCL and CCE and Percentage of districts Cold Chain transportation requirements at transportation where at least 90% of Equipment national, subnational and peripheral needs identified and active (e.g. electric, (CCE) and levels to ensure that there is adequate addressed solar, kerosene) cold transportation cold chain storage, logistics and ice chain equipment are resource pack freezing capacity at all levels. , Available data functional. (Target: requirements Ensure availability of power for active is used to drive >90%) equipment. Review availability of advocacy efforts funding for vaccines and Cold Chain with government and Percentage of districts Equipment (CCE) and advocate for partners to address with adequate cold domestic or local funding for existing gaps. chain storage space gaps. for polio SIA vaccines (Target: >90%) Use multiple sources including outcome of most recent campaigns, EVMa, CCEM inventory and other assessments, reviews and lessons learned to identify gaps which need to be addressed prior to next campaign, and advocate with the government and partners for corrective action. Support country to ensure SIA micro- plans and mapping exercise includes updated information on CCL, CCE and transportation needs at each level. Continued > 34
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