Source: Saúde Business Web - São Paulo / SP - 07/05/2010

In view of the globalized scenario and with an increasing demand for patient safety, the traceability of products in the healthcare chain has become the focus of companies and governments. In an interview with Saúde Business, the health director of GS1, a global organization focused on the development of standards for product traceability, Ulrike Kreysa, points out the trends in this segment and highlights Brazil as one of the first countries with a specific traceability regulation in health chain

Saúde Business: Drug traceability throughout the health chain has always emerged as a solution for safety, especially for patients, in addition to having a major impact on cost issues. Today, what is the relevance of drug traceability in health systems around the world?

Ulrike Kreysa: Safety and traceability of pharmaceutical products are at the forefront of government regulation and industry concerns around the world. As a result, numerous, and often irreconcilable, traceability solutions are being (or have already been) proposed to members of the supply chain, whose implementation brings significant additional costs to these members. Therefore, the health community is looking for a harmonized and standardized approach worldwide on traceability, while seeking to fully understand the importance of the issue.

SB: GS1 today works with standardization systems worldwide and with the exchange of information between participating entities. What is the great purpose of this exchange of information and what are the most advanced countries in this matter?

Ulrike: Accurate and up-to-date product information is essential for any commercial and supply chain management relationship. With regard to the exchange of main product data (a defined set of attributes such as size, quantity, etc. - “statistical data”), Australia is definitely the country that has the most experience so far with the exchange of standard and harmonized information. The National eHealth Transition Authority (NeHTA) created the National Product Catalog (NPC), which is from GS1 GDSN (Global Network Synchronization Data). The GDSN standard allows suppliers to enter information through any certified data, in addition to having it synchronized with other elements, such as the Australian NPC, allowing end users to have a “single point of truth” for accurate product information . 

With regard to the implementation of traceability systems (exchange of “dynamic information” - events, serial number), we have not yet seen a complete application in any country. Pilot projects have been conducted in Sweden by EFPIA (European Pharmaceutical Products Association), ETCO in Brazil and Swisslog in Switzerland. These three projects were enabled by GS1 standards, that is, with a unique product identifier (GTIN - from English, Global Trade Item Number) and a serial number (unique identification for each product). A large number of product packages have been involved in these pilots, and the positive results are very encouraging. In addition, the Turkish Ministry of Health is currently working on introducing drug traceability, but some practical challenges have already caused delays.

SB: In March, GS1 Healthcare US released the results of the working group for global data synchronization. Among the observations made, the difference in the level of automation between participating hospitals was pointed out with a point to be verified in the project. If in a developed hospital market like the American these differences arise, what are the major challenges for standardization in different countries, mainly in Brazil?

Ulrike: One of the most important implementation challenges is often the level of maturity of the supply chain participants. Especially in this case, hospitals need to develop and invest in knowledge and systems to automate their processes. Institutions interested in the United States and other countries paved the way for this evolution. Hospitals, associations and purchasing group organizations are also important in these processes to increase sensitivity and support implementation.

At the GS1 Healthcare Conference in São Paulo, which took place between 16 and 18 March this year, many Brazilian hospitals presented their current automation status. Much work has already been done in these hospitals and they can serve as best practices for other hospitals in the country (and in other countries as well). On the other hand, the size of the country and the diversity that exists between institutions can be considered a challenge. The execution will only be successful if all parties are conducting the same project. Regulation may force manufacturers to implement, but labor-intensive and incentives are needed alongside the hospital.

SB: In Brazil, the law that created the National Medicines Control System was passed last year, which requires the traceability of medicines. How do you evaluate this initiative and when compared to other countries in the world, what stage is Brazil at?

Ulrike Brazil is among the first countries with a concrete regulation of traceability of health care. Anvisa [National Health Surveillance Agency] announced that it intends to use the GTIN, in addition to additional information, such as a serial number on a GS1 DataMatrix, as the basis for its implementation of traceability, which is very much in line with global standards.

Recently, they added requirements for a specific security seal, which, according to the Pharmaceutical Research Industry Association (Interfarma), will bring cost and complexity.

SB: Many of the companies that are part of GS1 have global operations. How can traceability standardization projects help these companies in their performance?

Ulrike Various government regulations, service offerings and incompatible solutions have called on the healthcare community to define traceability as a business process supported by global standards. If this call is answered, traceability can improve patient safety, as well as chain efficiency. Global standards will also allow for the effective and efficient implementation of the traceability system in Brazil.

SB: You work with the concept of standardization for the production chain and work in several sectors. In health, at least in Brazil, there is a very strong resistance to standardization, especially when hospitals are involved. What are the advantages for the institutions that conform to these standards?

Ulrike Hospitals around the world will benefit from implementation standards such as cost reduction, in addition to improving inventory and efficiency management, and most importantly, improving patient safety. In the United States, major groups representing 90% of hospitals in the country are committed to introducing GLN (Global Location Number) as a standard for identifying locations / legal entities in a hospital or business partner by the end of 2010 and the GTIN (Global Trade Item Number) until 2012.

They ask for the same from their business partners if they want to continue doing business with him. Large hospital groups in Canada, France, the Netherlands and other countries have done the same. These hospitals are convinced of the benefits of standardization and unity.

SB: What impact can efficient drug traceability have on health chain costs? Today how much is spent on counterfeiting and diversion of medicines?

Ulrike Traceability is "the ability to control the movement of the specified stage of the supply chain and tracking forward and bring back the history, application or location of what is under consideration". With this, it is possible to have a quick and efficient recall of the product, in addition to the detection of counterfeit products that enter the supply chain and a correct and quick update of Electronic Healthcare Records.
It is very difficult to define spending on counterfeit drugs, even the WHO [World Health Organization] admits that there is an unconfirmed figure, but only estimates.

SB: When it comes to process improvements, how does GS1 work? Can you give me an example of improvements that positively impacted the health chain?

Ulrike The GS1 Global Health Traceability Standard (GTSH) provides a fundamental framework that describes the traceability process and defines the minimum requirements for all stakeholders, regardless of technologies, the size of the organization or organizational sophistication. GTSH allows for maximum interoperability between traceability systems in the health supply chain and borders. This is important because the health supply chain today is global and products are shipped worldwide after production. Thus, traceability must also be global - as requested by the WHO Impact group.

SB: What are the trends for standardization and for the exchange of information on this subject?

Kreysa: The trend is clearly to start tracking to avoid falsifying product authentication, as it allows for relatively quick and successful application. By checking products at the pharmacy before delivery to the patient, counterfeit products can be detected and the patient protected. Seriation will become increasingly important for drugs that are at risk of being counterfeited in the years to come. And the GS1 DataMatrix is ​​clearly the preferred data carrier for having an additional serial number or for barcode printing. A regulated agreement already exists in France, Turkey and Korea.

SB: What are the next steps for GS1 Healthcare in Brazil and worldwide?

Ulrike: GS1 Healthcare envisions a future where the Healthcare industry uses GS1 standards for all items, in all places, people and processes to drive patient safety and improve supply chain efficiency - starting with the manufacturer and ending with the patient.
Over the past few years, GS1 Healthcare has developed a number of important standards. For example, more than 100 industry experts have been involved in the standard development process for AIDC (Automatic Identification and Data Capture) - Application of Standards. The same for the development of standards related to the development of GDSN traceability and standards for health.
Now it's time for execution. The GS1 Member Organization and group of local health users around the world are committed to supporting the implementation of GS1 standards across the health chain. This should be done in a gradual approach based on experiences such as learning from the industries that conduct pilot projects and best practices. Local health user groups, such as GS1 Healthcare Brasil, will be instrumental in the engagement and training / education of all related parties. Local groups can plan and implement investments and help manage the process of change and learning from each other. On a global level, GS1 Healthcare will continue to push for global harmonization.