Issue 17, September 2013

Closing the book on project Optimizeby Michel Zaffran, WHO

In December 2007, a team of talented individuals from PATH and the World Health Organization (WHO) came together to form project Optimize, a five-year collaboration to identify ways in which supply chains can be optimized to meet the demands of an increasingly large and costly portfolio of vaccines. Our goal was to help define an ideal vaccine supply chain that can be used to develop stronger, more adaptable, and more efficient logistics systems, extending the reach of lifesaving health technologies to people around the world.

We decided to put our energy into three parallel streams of work:

1. Innovate—create an environment more conducive to innovation in both products and processes.

2. Demonstrate—generate more evidence on new ideas about supply chains and how they work.

3. Facilitate—inspire partner organizations and governments to invest in supply chain improvements over the long term.

As we look back, we can point to important achievements in each of these areas.

Innovate

In the area of innovation, Optimize played a role in reestablishing the Vaccine Presentation and Packaging Advisory Group. Optimize also contributed substantially to the first generic preferred product profile for vaccines as well as to WHO’s Programmatic Suitability for Prequalification guidance on vaccine products. We supported innovation in the cold chain equipment industry by issuing challenges for industry to develop new equipment such as battery-free solar refrigerators, long-life cold boxes, and large-capacity

ContentsClosing the book on project Optimize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

New vaccine presentations ease supply chain pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

SMS survey paves way for successful PCV and polio campaigns . . . . . . . . . . . . . . . . . . . . . . . 7

Optimize wraps up collaborations in six countries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

How can information systems help to improve the performance of immunization programs? . . 12

Why integrate supply chains? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

The need for ongoing innovation in vaccine cold chain equipment . . . . . . . . . . . . . . . . . . . . . 15

Announcements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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cold boxes. We also worked closely with WHO to help develop specifications for the prequalification of these new types of products and field-test new products in different countries around the world.

Demonstrate

In our collaborations with countries, we sought to document country experiences with innovative processes and systems including integrated supply chains, mobile warehouse delivery systems, a controlled-temperature chain for last-mile delivery of certain vaccines without ice, carbon-neutral supply systems, and several different types of immunization information systems.

Facilitate

We have facilitated the development of a multi-partner vision for vaccine supply and logistics systems in 2020 and a plan of action for its implementation. These efforts have generated momentum toward longer-term commitments from partner agencies and governments to invest in supply chain system improvements and product innovations over a longer time horizon. For example, the GAVI Alliance is working on an end-to-end supply chain strategy to complement new vaccine introductions. WHO and United Nations Children’s Fund (UNICEF) have also started working together on a major project to help countries make informed operational and strategic decisions about their supply chain systems following Effective Vaccine Management assessments. Nonprofit, government, academic, and industry partners, including PATH, Agence de Médecine Préventive, People that Deliver, the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative, John Snow Inc., the University of Pittsburgh, VillageReach, Logistimo, OpenLMIS, and the Developing Countries Manufacturers Network, as well as UNICEF and WHO, have ongoing programs to tackle issues related to vaccine products, supply system design, information systems, human resources, and equipment.

As Optimize closes its books this month, we are happy to see that work in these areas will continue and that countries will be supported as they strive to manage larger and more complex immunization programs.

At the global level, and in partnership with the vaccine industry, stakeholders are now shifting their focus from the procurement price of vaccines to the development and licensing of products that minimize total system costs and complication at the country level.

At the regional level, partners are working hard to help countries choose the right vaccine and cold chain products and make strategic decisions about how their supply chains are designed and managed.

At the national level, governments and immunization partners are beginning to invest in systems, processes, equipment, and professionals to ensure that newer vaccines are handled properly and reach the people who need them. The immunization supply chain is the backbone of immunization programs and can also become a backbone for other health interventions. It can support successful health interventions and help ensure that more people live a healthier life.

We are grateful to all those who have contributed to the Optimize effort: Ministry of Health colleagues in Albania, Guatemala, Senegal, South Sudan, Tunisia, and Vietnam, as well as the many colleagues in the public and private sectors who have helped to create the momentum for improved immunization supply and logistics systems. Last but not least, we are grateful to the Bill & Melinda Gates Foundation for making this enterprise possible.

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New vaccine presentations ease supply chain pressuresby Sy Gebrekidan (Merck), Debra Kristensen (PATH), Osman Mansoor (UNICEF), Gisele Corrêa Miranda (Fiocruz), Robert Steinglass (JSI), and Simona Zipursky (WHO)

In 2009, the Vaccine Presentation and Packaging Advisory Group (VPPAG) published its first generic preferred product profile (gPPP) for vaccines intended for use in public-sector immunization programs in low-resource settings. Informed by these recommendations, the World Health Organization (WHO) issued guidelines for Programmatic Suitability of Vaccine Candidates for Prequalification in the same year. Since then, several manufacturers have changed the presentation or packaging of their vaccine products to be more responsive to developing-country constraints.

For immunization programs in developing countries, getting vaccines safely and reliably to children in remote areas is a serious challenge. Exposure to excessive heat or freezing temperatures can compromise the potency of certain vaccines, and in low-resource settings it may be difficult to transport and store vaccines at the appropriate temperature. The addition of new vaccine formulations or presentations to these already stretched systems can generate further problems. Traditional cold chain systems lack the capacity to handle the much larger number of vaccines that exist today (though a number of timely new initiatives promise expansion and improved maintenance), while many new vaccines are presented and packaged in a way that can create serious management difficulties for countries with poor infrastructure.

Strengthening national immunization systems and providing support to health workers tasked with delivering vaccines will help to address many of these challenges. However, in environments with limited resources, protecting every child with lifesaving vaccines may not be possible without also improving the design and presentation of vaccines themselves. In fact, many supply chain problems can be best addressed at the earlier stages of vaccine development, where decisions relating to formulation, packaging, labeling, and presentation can make vaccines more suitable for distribution, storage, and use in low-resource environments. However, without effective dialogue with stakeholders in developing-country immunization programs, it can be difficult for vaccine manufacturers to take these perspectives into account.

Vaccine supply systems are the backbone of immunization programs as well as many other health interventions.

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Established in 2007, the VPPAG has become an important forum for discussion between the private and public sector on how vaccine products can be designed to suit the needs of developing countries. The VPPAG generic preferred product profile and workplan published by the VPPAG summarizes the agreed upon recommendations for vaccine producers and developers on formulation, presentation, labeling, and packaging of new vaccines for use by public-sector programs in developing countries. In recent years, manufacturers have demonstrated the adoption of these recommendations early in the vaccine development process. Several companies have also redesigned vaccine products to meet these recommendations in second- and third-generation products. Adherence to the product requirements of WHO Quality, Safety and Standards is essential for prequalification; alignment to the recommendations provided in the gPPP will help to ensure maximum market penetration and user acceptability in developing country settings.

One such recommendation in the gPPP states that vaccine product should ideally be in a format that “minimizes volume and weight of secondary and tertiary packaging, as well as the need for repackaging for in country supply chain distribution.” Following increased dialogue with vaccine manufacturers and developers, as well as the publication of the gPPP, several first-generation WHO-prequalified vaccine products have successfully been redesigned to decrease their volume per dose footprint, often helping to mitigate the need for increased space for cold storage and transport. For example, Pfizer (formerly Wyeth) updated their first-generation pneumococcal vaccine Prevnar® (licensed in 2007 and originally designed for high-income markets) from a prefilled glass syringe to a single-dose vial presentation (licensed in 2009) for developing-country use. The change in packaging and presentation reduced the cold chain space per dose required from 55.9 cm3 to 12 cm3. The four-fold reduction in volume now helps countries mitigate the need to invest in new refrigeration equipment to accommodate new vaccines.

In 2012, in response to recommendations provided by the VPPAG, the vaccine manufacturer Crucell also reduced the packaging size for their Quinvaxem® pentavalent vaccine from 13.1 cm3 to 10.3 cm3 per dose. These small changes in packaging increased the vial capacity of tertiary packaging (that is, the boxes used for shipment) by 17 percent, leading to more cost-effective shipping.

Before: Pfizer’s pneumococcal vaccine in a prefilled syringe presentation. Photo: Pfizer.

After: Pfizer’s pneumococcal vaccine in a low-dose vial presentation. Photo: Pfizer.

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The gPPP advises that manufacturers should “provide vaccines, whenever possible, in ‘ready-to-use’ presentations that do not require the mixing of components.” It also states that vaccines should be provided “in formats to minimize number of steps and potential for error during preparation and administration.”

Following feedback from health workers that GlaxoSmithKline’s (GSK) first-generation lyophilized rotavirus vaccine, Rotarix®, was difficult to reconstitute and consumed a significant amount of cold storage space, the vaccine manufacturer changed their lyophilized rotavirus vaccine (licensed in 2004) requiring 156 cm3 per dose to a ready-to-use liquid presentation in an oral applicator (licensed in 2007) requiring 85.3 cm3 per dose. GSK further developed a plastic tube presentation (licensed in 2010) requiring only 17.1 cm3 of space per dose to store and transport.

Another recommendation of the gPPP states that vaccine products should “maximize vaccine heat stability to improve effectiveness and enable higher temperature storage.” This trade-off in formulation and thermostability is challenging to achieve. However, GSK’s evolution of Rotarix® resulted in the meeting of developing country demands surrounding ease-of-use and small packaging volume, without compromising thermostability of the product (both products have a vaccine vial monitor 14 [VVM14]).

Before: GlaxoSmithKline’s Rotarix® vaccine in a lyophilized presentation. Photo: GlaxoSmithKline.

Before and after: Crucell’s Quinvaxem® vaccine presentations.

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The gPPP also states: “Vaccines packaged in prefilled injection devices should have both space-saving and auto-disabling features.” In response to this, Crucell has been developing a new presentation of its Quinvaxem® fully-liquid pentavalent vaccine in a compact, prefilled, single-use, autodisable device (cPAD). The company has introduced a novel secondary packaging design to minimize storage volume of Uniject™ cPAD devices to equal the volume per dose of a single-dose vial format.

The innovative resealable tray being developed by Crucell contains 20 Uniject™ injection systems and has been shown to fit comfortably in WHO-prequalified vaccine carriers. Twelve of these trays (containing a total of 240 devices) can be contained within a single carton. By comparison, just 50 single-dose vials of Quinvaxem® can be contained in a carton of comparable size.

Discussions with VPPAG members from WHO and PATH were important in advising Crucell in the development of their new presentation.

“VPPAG is a great way of establishing contact with the public sector,” explained Dr. Olga Popova, Head of Global Vaccine Policy at Crucell. “We talked to many stakeholders and got to understand the most

A resealable tray containing Quinvaxem® pentavalent vaccine.

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After: GlaxoSmithKline’s Rotarix® vaccine in a liquid presentation.

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important delivery problems facing developing countries. For us, it’s critical that advisory groups keep their doors open to industry so that knowledge can be shared and decisions can be well-informed and endorsed. If we have a question, we need to be able to ask the right people at the right moment of the development process.”

By working with the VPPAG and other immunization stakeholders to better understand country needs and constraints, vaccine manufacturers can make their vaccines more suitable for distribution, storage, and use in low-resource environments. Doing so has the potential to address some of the most pressing vaccine storage and distribution problems faced by immunization programs in developing countries.

Learn more about the VPPAG by reading the following article in the January 2013 edition of the WHO Bulletin:

www.who.int/bulletin/volumes/91/1/12-110700.pdf

Note: The statements, views, and opinions presented in this article do not necessarily reflect the opinions of Merck & Co., Inc.

SMS survey paves way for successful PCV and polio campaignsby Sean Blaschke and Lilian Nabunnya, UNICEF

On April 26, 2013, health workers at 3,240 health facilities in Uganda were sent the following short-message service (SMS) text message:

Does your Health Unit have a cold chain fridge for vaccines? Please answer YES / NO. If you have a fridge but it is not working, please tell us about it.

Within 48 hours, responses from 1,862 health facilities had been received. It was revealed that 391 facilities did not have vaccine refrigerators, and in those that did, 194 were not operational. Just 73 percent of health facilities that responded to the survey had working vaccine refrigerators—well below the World Health Organization/United Nations Children’s Fund target of 90 percent.

The arrival of this information was timely. Just one day after the SMS survey was sent, the Uganda National Expanded Programme on Immunization (UNEPI) introduced pneumococcal conjugate vaccine (PCV) to the routine immunization schedule, and with a nationwide polio campaign beginning in September, a functioning cold chain was more important than ever.

The survey provided UNEPI with an up-to-date list of the 194 health facilities with nonoperational refrigerators and the 391 health facilities with no refrigerators at all. The information was just a few days old, provided specific information on the nature of each problem, and included the contact details of the health worker who reported it.

Armed with this information on cold chain gaps, UNEPI and its partners met with staff at the National Medical Stores to address the problem. Tapping into a database of more than 16,000 registered health workers, UNEPI was able to contact thousands of health facilities, capture the results, and analyze them within 48 hours.

Gathering this sort of accurate and up-to-date information using traditional pen- and paper-based reporting systems would have been extremely difficult and expensive. But by using an SMS system to distribute and collect responses, the total cost of the survey came to less than US$150.

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The survey was managed by mTrac, a software application that uses SMS technology to track stock levels of essential medicines at health facilities in Uganda. Using their mobile phones, health workers provide the Ministry of Health with up-to-date information on drug supplies and disease outbreaks. Officially launched in December 2011, the system had now been deployed across the entire country. Each week, health workers at more than three thousand health facilities use their mobile phones to send information on stock levels and disease outbreaks. This information is then collected and validated by a central server. The data are made available to Ministry of Health and district health office staff using a browser-based web application. The system provides staff with timely, accurate figures with which to plan and monitor programs. It also enables donors and other partners to track the effects that their funding is having in real time, while identifying any bottlenecks or other issues as they occur.

The SMS survey on vaccine refrigerators was just one of several surveys sent using mTrac to assess the preparedness of health facilities for the introduction of the new PCV vaccine. The first was intended to measure the awareness amongst health workers of the forthcoming PCV immunization campaign. A simple question was asked: had health workers heard about the immunization campaign? Within 24 hours more than three thousand responses from approximately two thousand health facilities had been received.

Despite attempts to raise awareness on national radio and television, just 38.4 percent of health workers replied that they had heard about the PCV campaign. The survey revealed this lack of awareness was not the same in every district—some were significantly higher and lower than the average. In June 2013, this information was shared during an EPI partners meeting chaired by the UNEPI program manager; as a

A health worker in Amuru District shows off her phone after receiving training on mTrac.

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result, partners agreed to support districts with the lowest awareness.

The following week, a survey was sent asking health facility workers whether they had received their PCV stickers and put them on their cold chain storage fridges. It was found that only 25 percent of health facilities had carried out this activity. Again, data showed the districts with the highest and lowest number of health facilities that had completed this activity.

Another survey was then sent to more than ten thousand health workers from approximately 3,200 health facilities asking them about stockouts of key vaccines. The responses were alarming: 57.2 percent of health facilities replied that they were currently experiencing a stockout of at least one essential vaccine. The cause of the stockouts was subsequently investigated by UNEPI, the National Medical Stores, and district officials. The investigation revealed that additional vaccine management training was required, and as a result, vaccine management training has now been conducted.

The availability of timely, accurate, and complete health information is critical for the planning, accounting, monitoring, and evaluation of activities and interventions in the health sector. mTrac had proved itself an affordable and sustainable solution that is helping the Ugandan Ministry of Health to improve services and prevent stockouts.

To learn more about mTrac, please visit the mTrac website or email Sean Blaschke (sblaschke@unicef.org) and Lilian Nabunnya (lnabunya@unicef.org).

Optimize wraps up collaborations in six countriesby Dan Brigden, WHO

Over the last five years, project Optimize has worked closely with national immunization programs to explore innovative solutions to supply chain challenges. Each project has attempted to solve a particular immunization challenge—from an electronic immunization registry in Albania to a moving warehouse in Senegal, and from remote temperature monitoring in Vietnam to web-based stock management in Tunisia. The results of these projects have now been collected, analyzed, and published on the PATH and World Health Organization (WHO) Optimize websites.

“Optimize has learnt many things during its five years of existence,” observes project director Michel Zaffran. “We’ve seen successes and failures, and our efforts have contributed to catalyze efforts to explore innovative solutions to supply chain challenges. Now we need to share the lessons we have learnt so others can make use of them and continue the effort.”

Optimize collaborated with national immunization programs to demonstrate innovative solutions in six countries: Albania, Guatemala, Senegal, South Sudan, Tunisia, and Vietnam. Detailed information on the projects undertaken by project Optimize can be found in a set of country-specific Optimize reports available on the PATH and WHO Optimize websites. Also available is a set of evidence brief reports that provide brief summaries of key findings in particular areas.

Albania

In Albania, Optimize collaborated with the Albanian Institute of Public Health to help transform the way immunization data and vaccine stock are managed. The collaboration attempted to evaluate the benefits of two demonstration projects:

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1. Immunization Information System (IIS). The project developed and implemented an online immunization information system that can record immunization data and manage vaccine stock. The new system—named IIS—can schedule and record child immunizations, as well as manage vaccine stock and storage. The aim of the project was to measure the impact of accurate and timely immunization data on immunization and vaccine stock management.

2. Remote temperature monitoring. The project tested a short message service (SMS, or text message)-based system to monitor and log temperature conditions in peripheral cold chain equipment. The aim was to assess whether these remote alarm systems facilitate better vaccine and cold chain management than non-connected temperature loggers.

The Optimize Albania Report.

www.who.int/entity/immunization_delivery/optimize/Optimize-Albania_report.pdf

Senegal

In Senegal, Optimize collaborated with the Senegalese Ministry of Health to demonstrate innovations in the supply chain that can help the national immunization program to increase efficiency and improve performance, preparing the country for the introduction of new vaccines in the future. The following demonstration projects were undertaken:

1. Supply chain integration. This included integration of public-sector vaccine, drug, and other health product supply chains.

2. The moving warehouse. Specially equipped trucks are being used to deliver vaccines and other health products from the regional level directly to health posts.

The Optimize Senegal Report.

www.path.org/publications/detail.php?i=2272

Tunisia

In Tunisia, Optimize and the Tunisian Ministry of Public Health collaborated on three demonstration projects to explore new logistics and supply chain solutions that can optimize the vaccine supply chain:

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1. Streamlined and integrated supply chain. This project demonstrated the benefits of streamlining and integrating the storage and delivery of vaccine products with that of other public-sector health commodities that require refrigeration.

2. Net-zero energy supply chain. This project demonstrated an environmentally friendly vaccine supply chain at subnational levels using solar energy to achieve zero net energy consumption.

3. Computerized logistics management information system (LMIS). A computerized LMIS demonstrated tracking and tracing vaccines in real time throughout the supply chain, mitigating the risk of overstocking, expiry, and vaccine wastage.

The Optimize Tunisia Report.

www.who.int/entity/immunization_delivery/optimize/optimize_tunisia_report.pdf

Vietnam

In Vietnam, Optimize collaborated with Vietnam’s National Institute of Hygiene and Epidemiology to demonstrate new technologies and software systems that could be used to improve the performance of the vaccine supply and logistics system:

1. VaxTrak—a computerized system for tracking vaccine stock and reporting aggregated monthly immunization data.

2. ImmReg—a paper-based and computerized system for aggregated reporting of fee-based immunization services.

3. Computer- and mobile phone-based technologies for tracking children due for immunization and recording the immunizations given to them on an individual basis.

4. A new passive cooling device for storing vaccines in commune health centers.

5. New direct-drive solar refrigerators for storing vaccines in district health centers.

The Optimize Vietnam Report.

www.path.org/publications/detail.php?i=2269

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How can information systems help to improve the performance of immunization programs?by Jan Grevendonk, WHO

Project Optimize has worked closely with national immunization programs throughout the world to demonstrate innovative solutions to supply chain challenges. Many of these demonstration projects have involved the use of information systems to help improve the performance of immunization programs. The results of these information and communications technology (ICT) projects have now been collected, analyzed, and published. In addition, Optimize has also published several other resources that can help public health managers to plan for the implementation of information systems projects.

The results of these ICT projects have now been collected, analyzed, and published on the PATH and World Health Organization (WHO) Optimize websites. In addition, Optimize has also published several other resources that can help public health managers to plan for the implementation of information systems projects. A summary of Optimize ICT publications is provided below.

For a list of all Optimize publications, visit the PATH and WHO Optimize websites. For further information on all Optimize ICT demonstration projects, please contact Jan Grevendonk (grevendonkj@who.int).

Planning an Information Systems Project: A Toolkit for Public Health Managers

This toolkit can help public health managers plan for the implementation of ICT projects in health information systems. It focuses on the planning phase of an information systems project and proposes an eight-step process that can help decision-makers:

• Choose the solution that best fits their needs and context.

• Obtain the external help and expertise they need.

• Develop, scale, and then sustain their chosen solution.

www.who.int/immunization_delivery/optimize/resources/en/index5.html

Information Systems Used in National Immunization Programs

This series of short videos describes the impact of different information systems projects on the performance of national immunization programs. Each video explains the context in which a particular system was deployed, how it works, and what the impact has been.

Videos on IIS in Albania, ImmReg in Vietnam, Logistimo in South Sudan, VaxTrak in Vietnam, wVSSM in Tunisia, and vrMIS in Mozambique have been published. To view the latest videos, visit the PATH Programmatic Videos YouTube channel.

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A Case for Better Immunization Information Systems

This evidence brief discusses the rationale for improving immunization information systems and describes user experiences with different types of systems. It also provides advice on feasibility in different contexts. It draws on evidence gathered during project Optimize demonstrations in Albania, Guatemala, Senegal, South Sudan, Tunisia, and Vietnam.

www.who.int/immunization_delivery/optimize/resources/en/index5.html

Keeping Track of Vietnam’s Vaccines

This fact sheet describes how project Optimize worked in Vietnam with national, regional, and local partners to help introduce VaxTrak, a software program that allows users at various levels of the health system to track vaccine stock and report monthly immunization activity.

www.path.org/publications/detail.php?i=2225

Vietnam’s Immunization Registries Go Online

This fact sheet describes how project Optimize worked with government and software partners in Vietnam to introduce a digital immunization registry named ImmReg. This registry allowed the health system to better track children due for vaccination and shortened the time required for recording and reporting immunizations, compared to the existing paper-based registry.

www.path.org/publications/detail.php?i=2273

Before and After: How an Online Immunization Registry Has Benefitted Health Workers in Albania

Starting in 2009, the Albanian Institute of Public Health collaborated with project Optimize to implement an online immunization information system (IIS) that can schedule and record all child immunizations in the country, as well as manage vaccine stock and storage. It was first implemented in one district in 2011 and will be gradually deployed to all other districts over the next three to five years.

This photo set illustrates how the new system has benefitted health workers in Albania. The “Before” pictures describe how health workers used the previous paper-based registry, while the “After” pictures describe how they are now using IIS.

www.who.int/immunization_delivery/optimize/albania/en/

Albania Pilots an Immunization Information System

The Albanian Ministry of Health, in collaboration with project Optimize, developed a registry-based immunization information system named IIS. This fact sheet illustrates how the data the new system produces has been used to improve the management of the country’s vaccination program, how it is changing the way people collaborate, how it ensures timely and equal access to immunization for all children, and how it reduces the administrative burden on staff.

www.path.org/publications/detail.php?i=2253

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Why integrate supply chains?by Patrick Lydon, WHO, and Prashant Yadav, University of Michigan

Project Optimize has recently published a document that examines the benefits, challenges, and rationale for integrating vaccine supply chains with the supply chains of other health commodities. It provides agencies, donors, decision-makers, and partners with a brief overview of supply chain integration and lessons learned during Optimize demonstration activities in Senegal and Tunisia.

For historical reasons, most disease control programs in low- and middle-income countries, including immunization programs, manage and operate independent supply chain systems. However, many of these programs are under increasing pressures to move larger volumes of higher-value products from the national to service-delivery levels. Immunization supply chains in particular will require significant investments before they will be ready to handle increased volume of new and more-bulky and -expensive vaccines. Without addressing these challenges, vaccine supply chain systems are likely to be a bottleneck to new vaccine introduction.

As immunization supply chains struggle to meet current and upcoming challenges, the lines are being blurred between vaccine supply chains and those designed for other health commodities. Historically, vaccines were the only set of health products requiring a cold chain, and hence a vertical supply chain was justified. Today, a number of pharmaceutical products, such as some antiretrovirals and antibiotics, now require controlled temperature storage, which has led to new opportunities for supply chain integration between vaccines and other public health commodities.

Supply chain integration is a major structural undertaking that can be very difficult but also very effective in the long term. By moving from vertically managed programs toward horizontally integrated systems, public health programs may be able to improve both efficiency and effectiveness as long as the right steps are taken. Potential benefits include:

• Increased economies of scale using infrastructure, equipment, and human resources at full capacity and selling or relocating unneeded warehousing facilities, vehicles, and refrigerators to elsewhere in the health system.

• Increased flexibility and adaptability to enable expansion of products and growth of the network through a clear, segmented framework of operations.

• Improved efficiency through better use of existing resources, streamlined delivery routes, and specialization of supply chain professionals.

• Improved performance of supply chains and disease control programs.

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For more information, refer to “Integrating the supply chains of vaccines and other health commodities.” This document is available on the PATH and World Health Organization websites.

The need for ongoing innovation in vaccine cold chain equipment by Tina Lorenson, PATH, and Joanie Robertson, GAVI Alliance

Newer vaccines often require more cold chain space and more reliable cooling equipment than traditional ones. For many national immunization programs, these requirements present a serious challenge. Aware of the problem, for the last five years project Optimize has been working closely with cold chain equipment manufacturers and other partners to identify possible solutions.

An early landscape analysis of cold chain equipment pointed to the need for innovation in several areas, including:

• Freeze-proof cold chain equipment.

• Next-generation solar vaccine refrigerators that do not require energy-storage batteries.

• Large-sized vaccine cold boxes and carriers for transport.

• Long-life cold boxes that can provide up to 30 days of cooling for locations without refrigerators.

To encourage innovation in these areas, Optimize issued “industry challenge” contests to companies and rewarded those that presented viable products by supporting laboratory- and field-testing of their products. Optimize also worked closely with the WHO Performance, Quality, and Safety (PQS) programme to ensure that new specifications were developed for solar direct-drive refrigerators (which do not require energy storage in batteries) and large-sized and long-life cold boxes. The results of this work have been gratifying. As of July 2013, eight new solar direct-drive refrigerators and/or freezer combination units have been prequalified by the WHO PQS programme and several promising long-life and large-size coolers are being refined for prequalification.

The need to prevent freezing in vaccine cold chain equipment has also led to new innovations throughout the supply chain. Along with the United Nations Children’s Fund and the Cold Chain and Logistics (CCL) Task Force, Optimize has invested in testing temperature-monitoring devices that can detect heat or freeze incidents. In some cases, data from these temperature-monitoring devices can be transmitted via the Internet or cellular phones, enabling faulty refrigerators and incorrect procedures to be more readily identified. Manufacturers are also starting to explore the possibility of using phase change materials instead of water packs in cold boxes and vaccine carriers to avoid the risk of freezing. Other manufacturers have experimented with insulation materials and configurations to prevent the risk of freezing in refrigerators and other cooling devices. These technologies are needed worldwide, where it has been documented that 35 to 70 percent of vaccine is exposed to freezing temperatures during its journey along the cold chain.1

Ongoing innovation in cold chain equipment will require encouragement—manufacturers need clear signals from vaccine supply chain experts about what ideal requirements are needed for this market. Field-tests that provide feedback to manufacturers can lead to ongoing product improvements. Better documentation of equipment performance can also help users decide where to invest their limited

1. Matthias DM, Robertson J, Garrison MM, Newland S, Nelson C. Freezing temperatures in the vaccine cold chain: a systematic literature review.

Vaccine. 2007;25(20):3980–3986.

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resources and keep equipment in good working order over time. Several organizations and groups are currently working on cold chain equipment improvements, including the CCL Task Force, WHO, UNICEF, PATH, the Bill & Melinda Gates Foundation, and the GAVI Secretariat. Look for new products in the PQS catalogue online.

The following summaries of Optimize demonstrations and field-tests with cold chain equipment are available:

• Direct-drive solar vaccine refrigerators: a new choice for vaccine storage (evidence brief)

• Installing and testing battery-free solar refrigerators in Vietnam (photo book)

• Innovative passive cooling options for vaccines (evidence brief)

• Unplugged and keeping cool: testing off-grid storage solutions in Vietnam (demonstration summary)

• Using solar-powered refrigeration for vaccine storage where other sources of reliable electricity are inadequate or costly (article in Vaccine)

Announcements6th Annual Global Health Supply Chain Summit

The 6th Global Health Supply Chain Summit will be held in Addis Ababa, Ethiopia, November 18–20, 2013. The summit will focus on innovations in global health supply chains and explore emerging trends in information acquisition and sharing, coordination across stakeholders to improve efficiency and service, and best practice ideas on public-private partnerships.

For more information, please visit the 6th Global Health Supply Chain Summit website or contact Yehuda Bassok (ybassok@marshall.usc.edu).

The Best Shot: reaching 22 million missed children

On October 14, 2013, in Oslo, Norway, Médecins Sans Frontières (MSF) will host a seminar on accelerating access to vaccination. At this gathering, MSF aims to stimulate discussion amongst stakeholders across the vaccination community on the barriers to accessing vaccination. The seminar will highlight issues of access to vaccination and examine innovative solutions to address challenges related to vaccine products, pricing, and delivery.

For more information, please contact Kate Elder (kate.elder@newyork.msf.org).

Issue 17, September 2013 Page 17

ResourcesUse of MenAfriVac ™ (meningitis A vaccine) in a controlled temperature chain during campaigns

In 2012, the license for the Serum Institute of India’s meningitis A vaccine, MenAfriVac™, was changed based on a thorough review of scientific data by regulatory authorities and the World Health Organization to allow for the use of the vaccine for a period of up to 4 days at temperatures of up to 40°C in a controlled temperature chain. This document provides countries with guidance on when and how to take advantage of this flexibility.

www.who.int/immunization/documents/WHO_IVB_13.04_5_6

Energy and Connectivity for Health

On June 12, 2013, the United Nations Children’s Fund hosted a forum in New York to start a conversation on how to provide energy and connectivity for health to “off-grid” communities. The meeting report is now available on the Energy and Connectivity for Health website, where we hope to continue the conversation by gathering ideas and experiences.

https://sites.google.com/site/energyconnectivity4health/home

HPV Vaccine Introduction Clearing House launched

The HPV Vaccine Introduction Clearing House is a unique space to find WHO publications, tools, and other important resources on the human papillomavirus (HPV) vaccine. The purpose is to help guide HPV vaccine policy, program, and communications managers in the development of successful strategies for the introduction and sustained delivery of HPV vaccination at a national level.

www.who.int/immunization/hpv

New outputs from project Optimize

Project Optimize has recently published a variety of documents on both the PATH and World Health Organization Optimize websites.

OptimizeBatiment Avant Centre, 13 chemin du LevantFerney Voltaire 01210 FRANCE+33.450.28.43.75 | technet-21.orgwho.int/immunization_delivery | sites.path.org/vpsse/optimize/

Evidence briefs: This series of short documents in both English and French compiles knowledge generated in specific topic areas during our demonstration projects and research in various parts of the world. Topics include:

• The case for better immunization information systems

• Integrating the supply chains of vaccines and other health commodities

• Outsourcing vaccine supply chain and logistics to the private sector

• Innovative passive cooling options for vaccines

• Solar direct-drive refrigerators: a new choice for vaccine storage

• Net-zero energy supply chains: a glimpse into the future (available end of September)

Photo books: This series of photographs with captions documents some of our work visually, allowing people to get a sense for how certain aspects of supply chains might look in a real-life setting.

• Before and after: How an online immunization registry system has benefitted health workers in Albania

• Installing and testing battery-free solar refrigerators in Vietnam

• Delivering MenAfriVac™ using the controlled temperature chain approach

• A moving warehouse delivers vaccines and essential health supplies in Senegal

Country reports: This series of longer reports summarizes all activities undertaken in each of our demonstration projects and provides results from each documented intervention.

• Optimize: Albania report

• Optimize: Guatemala report (coming soon)

• Optimize: Senegal report

• Optimize: South Sudan report

• Optimize: Tunisia report

• Optimize: Vietnam report

Above Zero: Strategies to Prevent Vaccine Freezing

This 4-minute animated video emphasizes the difficulty and importance of maintaining proper temperatures in the vaccine cold chain. The risks of exposing vaccines to freezing temperatures are now known to be significant. These risks can be reduced through health worker training, temperature monitoring, investing in new freeze-safe cold chain equipment, and in vaccine formulations that can withstand cooler temperatures.