Discussions marquées : Barcode

"THE BOOK OF VVM: Yesterday-today-and-tomorrow" is now available for free download

The story of a time and temperature indicator (vaccine vial monitor) that has dramatically changed the course of vaccine management practices as well as shaped the future of cold chain, THE BOOK OF VVM: YESTERDAY-TODAY-and-TOMORROW is now available for free download in ePUB3 and PDF formats. http://kartoglu.ch/vvm We may ask ourselves where humanity might be without some of the greatest inventions that have come to pass. Great ideas have continuously changed the path of human civilization over time with vaccination being widely considered one of the greatest medical achievements of modern civilization. Many commonplace and preventable childhood diseases are now increasingly rare because of vaccines. The concerted human effort to bring the vaccines to the ones who need them at the right time is remarkable. Just one example of the dedication and self-sacrifice involved was the 1925 ‘Serum Run’ between the settlements of Nenana and Nome in Alaska also known as the Great Race of Mercy. This involved a famously grueling winter expedition across the frozen Alaskan interior using dog-sled relays to take diphtheria antitoxin to the beleaguered township of Nome where an outbreak of diphtheria was threatening around 10,000 local Alaskan natives who had no natural immunity to this lethal disease. The epic journey took 20 mushers and about 150 sled dogs just five and a half days to cover the 1,085 km route. This display of bravery and determination was how the small town of Nome and the communities surrounding it were saved from an incipient epidemic. Balto, the lead sled dog on the final leg into Nome, became the most famous canine celebrity of the era. Balto’s statue became a popular tourist attraction both in New York City’s Central Park and downtown Anchorage in Alaska. The vaccine vial monitor (VVM) is one of the most important inventions of the last century; one that has dramatically changed vaccine management practices and continues to shape the cold chain. In 1996, when VVMs started to get to countries with the oral polio vaccine (OPV), I was the health officer for the UNICEF Central Asian Republics and Kazakhstan Area Office. I remember one particularly cold night going to the airport in Almaty at 03.00 am to receive the very first shipment of OPV with VVMs. For years, I was a humble VVM user and advocate in the field. Things started to change when I was hired by the WHO Headquarters ‘Access to Technologies’ team in 2001 and VVM became one of my prime responsibilities. That was at a time when vaccine manufacturers were dragging their feet about incorporating VVM onto vaccines other than OPV. My brief was to overcome this resistance from the manufacturers, an objective that formed the basis for my plans for the historic 2002 VVM technical consultation meeting. In 2007, I immensely enjoyed organizing the event to celebrate the 10th year anniversary of VVM introduction. Visiting Niger, Indonesia, and Vietnam for the shooting of the “Five Senses” video is full of cherished moments. Towards my retirement in August 2018, I conceived the idea of writing this book. I was one of the few people who had witnessed the decades-long programme of VVM development from its birth to its maturity. I had worked with sweat and tears to get VVMs onto all vaccines as well as tirelessly helping vaccine managers and health staff to excel in using the VVMs to their utmost potential. Today, it is a great pleasure to see one of my e-VVM based vaccine management course graduates (2015), Junaidu Adamu Barde from Nigeria, working for the Clinton Health Access Initiative, using the course learning materials to duplicate efforts in his country. I worked on this book from September 2018 to August 2019. I went through every single published and unpublished work on VVMs, watched all available videos about VVMs and the early contending products, talked to key people, some face to face, others over the phone. I visited the U.S., Albania, Burkina Faso, and Sierra Leone. Unfortunately, there were some people I just could not reach despite all my efforts with email and phone messages. And, although I considered myself highly knowledgeable about VVM, I was simply amazed at the volume of new information I discovered and the knowledge I gained. I had originally wanted this book to be a concise, structured, globally-relevant manual that provided comprehensive information on a wide scope of issues; in other words, an ‘A-Z of VVM’. In the event, it turned out to be more voluminous than I thought. I did not want to restrict myself when there are so many clever, dedicated and selfless individuals that have made this near-miraculous innovation a reality and in doing so contributed to saving, literally, the lives of millions. So, I am happy that it became a celebration of all the efforts of individuals, organizations, agencies, donors, and manufacturers involved in the development, scaling, applying, advocating for, enforcing, helping health workers to excel in their practice, and using it. As with my previous books, I have again licensed this work under the Creative Commons (CC) Attribution-NonCommercial-ShareAlike 4.0 International License (CC BY-NC-SA 4.0). The book can be reproduced, remixed, tweaked or built upon non-commercially. I am grateful to Temptime Corporation, and especially to Renaat Van den Hooff and Ted Prusik for sponsoring the creation of this book. I thank Emily Moore for the VVM literature list she put together, it eased my search enormously. I also thank all the individuals I have interviewed for their time and everything they have shared with me. I am thankful to all my colleagues who sent me photographs, and documents. Many thanks to Kadir Abbas for making again an excellent job on the cover and page design, print, and ePUB3 conversion. Gencer Yurttas deserves a special thank you for his immaculate VVM photography. I deeply appreciate Alan Kennedy for his editing work, and Umran and Gokhan Akaalp's help in developing the book’s website. I am grateful to my wife Nellie and daughter Deniz Nala who supported me with love. Deniz Nala was already helping me at the age of 14 measuring VVMs with a spectrodensitometer and entering data into an Excel sheet to calculate optical density differences during a VVM based vaccine management eLearning course. I never imagined that for something only 0.38 cm2 in size that I could write a book of 424 pages. This ‘little big thing’, now reinventing itself with the incorporation of a peak threshold indicator as well as entering the digitized supply chain with the integration of 2D barcodes, never ceases to amaze me. For download please visit http://kartoglu.ch/vvm The book is available both in interactive PDF (32.9 MB) and ePUB3 (24.4 MB) versions. 424 pages...  

Solving immunization supply chain challenges with blockchain technology?

I am really interested in the potential benefits that blockchain technology could bring to immunization. There have been many discussions on vaccine packaging and barcoding as I can recall, and I was wondering if blockchain technology was mentioned (or even central now!) during those discussions, and also if some of you would have some stories to share about using this technology at all.  It seems from several sources, including the World Bank that blockchain technology can provide a cost-effectiev solution to many challenges encountered by government-led supply chains, such as maintaining vaccine quality throughout the supply chain or ensuring vaccine availability at service delivery points. In addition to that, by allowing to track vaccines from lab to patient, particularly where a network of various players in different geographies are involved, blockchain technology would then aid to prevent fraudulent products entering the supply chain and bring down the risk that ineffective counterfeited products represent for public health. That could be quite an interesting opportunity, especially since the WHO estimated that countries are spending about $30bn on counterfeit drugs, that cases of counterfeited yellow fever and MenA vaccines were reported and that WHO thinks most cases of fake medicines re likely to be unreported (see this article).  I'd love to hear from immunization on what their thoughts, hopes and possibly criticisms would be! Thanks all and have a great day!

Visibility for Health Systems: Adoption of Global Data Standards (GS1)

Dear colleagues,  Please find attached from the Interagency Supply Chain Group.  Kind regards,  Hitesh  Coordinator for the Interagency Supply Chain Group (ISG)       Hitesh Hurkchand
Interagency Supply Chain Group
Hosted by the World Health Organization 
Mobile: +1.917.975.9743 [WhatsApp, Viber]
Skype: hitesh_h
New York, New York

Feasibility and Limitations of Vaccine Two-Dimensional Barcoding Using Mobile Devices

In case it's of interest.

Tanzania leading the way with barcodes on vaccine packaging

by Daniel Thornton, GAVI; Henry Mwanyika, PATH; Drew Meek, WHO; Ulrike Kreysa, GS1 A project in Tanzania is exploring how best to implement barcodes on vaccine packaging. By adding barcodes to the shipping containers and secondary packaging used to transport vaccines, project organizers hope to learn how barcode technology can improve supply chain management and vaccine safety in developing countries. Over the last 40 years, barcodes have transformed global supply chains in the packaged food and consumer products industries. Most supermarket chains around the world use barcode scanners at the checkout counter, and most smartphones can now scan barcodes. Barcodes make it easy to track the flow of goods from their point of origin to their final destination, to recall products that may pose a safety hazard, to detect counterfeit or fraudulent goods, and to link a product with information such as where it was made, where it has been, ingredient lists, and instruction manuals in multiple languages. The global immunization community has recently started to explore the potential of using barcodes in vaccine supply chains. In fact, some countries have already begun to establish and mandate their own barcode standards. But with developing-country immunization programs lacking the infrastructure required to scan and use barcode information, and without a global barcode standard to follow for vaccine products, the use of barcodes on vaccine products destined for developing countries is happening much more gradually. Electronic health information systems are becoming increasingly pervasive in developing countries, especially at the central warehouse level. This has reduced some of the barriers to the use of barcodes and at the same time made the need to establish global standards more pressing than ever. Such standards would make it much easier to correctly implement and interpret barcodes coming from different suppliers around the world. In March 2013, a working group of the Vaccine Presentation and Packaging Advisory Group (VPPAG) met in Brussels, Belgium, to identify the challenges and set out a long-term vision for the adoption of barcode technology in developing-country vaccine supply chains. The meeting was hosted by GS1, the nonprofit global supply chain standards organization, and was attended by representatives from the United Nations Children’s Fund, the World Health Organization (WHO), PATH, the GAVI Alliance, and several vaccine manufacturers. The group concluded that: -There are no longer any major obstacles to the introduction of barcodes on secondary packaging[sup]1[/sup] and packaging containing secondary packaging. -Adding barcodes with lot number and expiry date information to primary packaging (the vaccine vial or ampoule) poses a technical challenge that may take several years to overcome. -Overall agreement exists on standards for the type of information that should be included in barcodes, the type and format of barcode to use, and the levels of packaging on which it should be included. -Online databases need to be established where barcode information can be retrieved (for example, for a logistician to find out that the item he has just scanned is a box of 25 vials of measles, mumps, and rubella vaccine that needs to be stored between 2°C to 8°C). An existing WHO vaccine product database can potentially be adapted to serve this purpose. -The planned project in Tanzania presents a great opportunity to evaluate the benefits of using barcodes on vaccine packaging. For the project in Tanzania, collaborating manufacturers will add barcodes to the shipping containers used to transport vaccines to Tanzania. Encoded in each barcode will be a serial shipping container code, an 18-digit number used to identify individual containers and provide dispatch information. In parallel to the shipment, an advanced shipping notice will be sent. Upon arrival, the barcodes will be scanned by logisticians to automatically generate key sections of the vaccine arrival report. Collaborating manufacturers will also add barcodes to secondary packaging to enable staff to keep track of vaccines as they move further down the supply chain from the national to the regional and then to the district level. Encoded in these barcodes will be the product’s global trade item number, as well as the lot number and expiry date of the vaccines contained in the secondary packaging. This will enable Tanzanian logisticians to keep better track of vaccine stock movements. Because the benefits of barcodes to vaccine supply chains is becoming increasingly evident, and interest among developing-country governments in barcodes continues to grow, it will be critical for vaccine products with barcodes to be ready in the public-sector supply chain. For this to happen, both global- and national-level decision-makers can take positive steps toward a future where barcodes are an essential component of vaccination programs. To learn more about the work of the VPPAG barcode working group, please contact Daniel Thornton (dthornton@gavialliance.org), Henry Mwanyika (hmwanyika@path.org), Drew Meek (meekd@who.int), or Ulrike Kreysa (ulrike.kreysa@gs1.org). To read more about the need for global barcode standards and the readiness of developing countries to introduce barcodes, please read the article “Is it time to start barcoding vaccine labels” in the July 2011 edition of the Op.ti.mize newsletter. [size=10]1. Secondary packaging includes the primary packaging (the vaccine vial or ampoule), the packet containing the vaccine vial, and any intermediate packaging.[/size]

2D Vaccine Barcode Pilot (CDC)

Cross-posted from the CDC website with thanks. In September 2011, CDC initiated a pilot project to test the implementation, using industry barcoding standards, of 2D barcodes on vaccine products. A 2D vaccine barcoding manufacturer's forum was conducted in January 2012 to inform manufacturers and other stakeholders about the pilot project and to identify challenges and potential solutions. Over 60 industry stakeholders attended, including representatives from vaccine manufacturing companies, retail pharmacies, standards organizations, as well as the World Health Organization (WHO), The Food and Drug Administration (FDA) and CDC. A report summarizing the forum is now available. There are three major components of this pilot: pilot implementation of 2D barcoded vaccines, development of barcodes for vaccine information statements (VIS), and development of technical assistance documents for pilot participants and future implementers. Pilot Implementation of 2D Barcoded Vaccines – The project will ensure implementation of 2D barcoding in one or more manufacturing settings and a sample of provider offices, with special emphasis on the interfaces between barcoded vaccines, EMRs, and IIS. The project has enlisted two vaccine manufacturers, 10 CDC 317 Immunization grantees, and approximately 220 immunizers as pilot participants. The immunizers include private providers, publically-funded health services, and one pharmacy. The manufacturer placed 2D barcodes containing product identifier, lot number, and expiration date onto specific vaccines. These barcoded vaccines were distributed to the participating providers. The providers will administer these barcoded vaccines, and then use scanners to read the 2D barcodes. The scanned data items will be input into the immunizer’s electronic record systems for each patient, and transmitted to or captured by the states' IIS. The purpose of this implementation pilot is to assess the extent of using 2D barcoded vaccines and scanners on the completeness and accuracy of vaccine data. The vaccine information will be tracked from manufacturer to immunizers to EHR to IIS. A subset of the participating immunizers will be selected to participate in a work flow analysis (WFA) and time and motion study in order to assess the impact of 2D scanners and barcoded vaccine products at administration and inventory. This phase will include process maps, time measurements and staff interviews. These will be collected both before and after the introduction of 2D capabilities within the provider site.

Is it time to start barcoding vaccine labels?

by Drew Meek, WHO/QSS; Sheila Cattell, IFPMA; and Joanie Robertson, PATH In the packaged food and consumer products industries, barcodes have become a way of life. Most large supermarkets around the world use barcode scanners at the checkout counter, and an average smartphone can now scan barcodes. Barcodes make it easy to track the flow of goods from their point of origin to their final destination, to recall products that may pose a safety hazard, and to link a product with a great deal of information such as where it was made, where it has been, ingredient lists, and instruction manuals in multiple languages. Given the ubiquity and utility of barcodes, why are they not widely used on vaccines? In fact, barcodes are included on the labels of some vaccines sold in industrialized countries. Without information systems and hardware in developing-country immunization programs to scan and use barcode information and without a global barcode standard to follow for vaccine products, the application of barcodes on vaccine products destined for developing countries is happening much more gradually. The need for global barcode standards Global standards make it easier to correctly implement and interpret barcodes coming from any number of suppliers in different countries of origin. In the absence of global standards, the national regulatory agencies of individual countries are forced to manage multiple different standards on different products or to come up with their own standard which leads to barcode information that is not compatible with systems in other locations. [color=#999999][Click photo to enlarge] [/color] GS1 is a nonprofit entity leading the design and development of global standards for supply and demand chains, and their standard appears to be emerging as the leading global solution for product information. Their standard product numbering schema, called the Global Trade Item Number®, identifies the manufacturer and product. From there, depending on the type of barcode used, it is likely that vaccine lot numbers and/or expiry dates would be included in the barcode, and in higher-capacity barcodes perhaps other data as well. Most importantly, using a global standard identification barcode allows different countries and entities to link the product to a record in a product database containing all the information they need and ensures that the identification number will be unique. Obtaining global agreement on a standard for the type of information that should be included, the type and format of barcode to use (one dimensional versus two dimensional), and the levels of packaging on which it should be included is a difficult but critical hurdle to overcome before a really useful system of barcoding for vaccines can be adopted. Because most vaccines destined for low-income countries are prequalified by the World Health Organization and procured through the United Nations Children’s Fund, these organizations have a powerful role to play in proposing a global standard for barcodes on all public-sector vaccines. The Vaccine Presentation and Packaging Advisory Group of the World Health Organization has initiated a discussion around the concept of primary-label barcodes and is gathering information from regulatory agencies for guidance, including the United States Center for Disease Control and Prevention. The additional complexity of placing a barcode on primary labels is the limited amount of available label space and the need for specific placement to compensate for vial curvature for some code formats. The goal is to contribute to the current global discussion on barcodes for vaccines and ensure that the anticipated needs of developing countries are considered alongside the needs of industrialized countries. Country readiness for barcodes Another major hurdle is the fact that most developing countries are not yet ready for barcodes on vaccines. Existing information management systems in most countries are not equipped to take full advantage of the added value and benefits of barcodes. Many countries are starting to build more sophisticated systems within their immunization programs as an increasing number of cost-effective software and hardware solutions are becoming available along with technical capability to support implementation and long-term management. In the short term, however, demand for vaccine barcodes in developing countries is still quite low. A handful of countries have begun to demonstrate the value of barcodes on vaccines. For example, Health Canada is in the process of adopting GS1 standards for vaccine product identification and recently recommended piloting a two-dimensional format with information on lot number and expiry dates on both primary and secondary packaging. This effort will make it possible for Health Canada to develop complete electronic health records, reduce immunization errors, improve inventory management and forecasting, and maintain more accurate immunization coverage rates. If a similar effort was successfully deployed in developing countries, barcodes could also help facilitate lot recalls, allowing the health system to identify specific children that were vaccinated with a particular lot and determine where leftover stock is sitting. Barcodes linked to a database could also be used to provide relevant information about the vaccine, proper administration, and safety warnings in local languages to users. All of this is possible with barcodes but only if the necessary systems and infrastructure are in place and functional enough to support proper use. Over the next decade, as more and more developing-country governments become interested and are ready to implement barcode tracking systems in their immunization systems, it will be critical for vaccine products with barcodes to be ready in the public-sector supply chain. For this to happen, both global- and national-level decision-makers can take positive steps toward a future where barcodes are an essential component of vaccination programs. We encourage your questions or comments. Please click reply at the bottom of the page.
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