23rd GS1 Traceability Event

Generales

By Rocío Mellas

Improving patient safety is a challenge for everyone. In fact this was the slogan for the 23rd Global GS1 Conference, which was held between the 23rd and 25th of April at the Marriott Plaza Hotel. The key issues addressed included: trends and developments in the use of standards, traceability, data exchange medical devices and patient safety. 

The event, organized by the GS1 Global Office in collaboration with GS1 Argentina, gathered together national and international figures from the healthcare sector; including manufacturers, importers, distributors, drug manufacturers, pharmacies, care centers, schools, associations, universities and official regulatory agencies.

“When GS1 Global holds this type of event in the world it is to inform the sector of what can be done,” said Mario Abitbol, Healthcare Leader at GS1 Argentina. And he went to explain why Buenos Aires was the host for this event: “Argentina is one of the Latin American countries that has grown the most in terms of medication monitoring; implementation of traceability has occurred more rapidly and this was why the country was selected as the venue for the Global Conference.”

Rubén Calónico, the General Manager of GS1 Argentina, also highlighted the country’s importance: “Argentina is perhaps the only country that has an advanced, well executed medication traceability system. It is a desirable location for all those who are in the field of healthcare,” he said.

Through informative conversations, conferences, analysis of case studies and local implementation, the speakers agreed with regard to the importance of encouraging the adoption of solutions and identification and traceability practices. But how? One of the possible alternatives is to use GS1 global standards. This is a key concept: all the participants in the chain should speak the same language to optimize their processes and improve patient safety. 

 

Towards the traceability of medical equipment

 Meeting traceability standards and regulations is not a simple task: it requires input from many different links in the value chain. But it is possible. The secret lies in optimization.

“We need to innovate and provide training. Traceability, data availability… there are many processes connected to making a change. Simplicity makes the supply chain more efficient”, said Camilo Rueda, Manager of Relations at McKinsey and Company.

Meanwhile, Luciano Di Cesare, the Executive Director of INSSJP – PAMI, spoke to actors in the sector, saying: “I invite you to evolve, to acquire new technologies and adopt new standards and offer more security”. On a related note, Di Cesare received an award for his implementation of a traceability system with GS1 standards in Argentina.

 

Traceability and Taxation of Medications in Argentina

 Since 2011, when the Law on Traceability of Medications was announced in Argentina, ANMAT began to work with PAMI on regulation. Although the implementation was gradual – the model started out monitoring 88 assets – it currently traces one hundred per cent of assets on the market.

María José Sánchez, Coordinator of the National Program for the Control of the Medication and Medical Products Markets at ANMAT, stated that 24 laboratories, 8060 pharmacies and 450 drugstores are participating in the traceability system. And added: “We are committed and involved. We aren’t only tracing the route the medications take but also focusing very closely on their tax status through the work of the ANMAT inspectors at every link in the medication sale chain.”

Given that the National government’s system is federal, each province is autonomous and has its own regulations. For this reason it is important that provincial Ministers of Health commit to the project to increase its effect. Today, 14 of 27 Argentine Provinces are incorporated into the National Traceability System.

Maximiliano Derecho, a legal advisor to the National Medication and Medical Product Monitoring Program run by ANMAT, announced that a new medication identification system is to be launched that will include two new technologies: firstly, the die stamps on containers will be replaced by labels or paper stamps – which cannot be removed without leaving a clear mark on the container– and secondly, a change in the computer systems currently used will be required – pharmacies must buy readers for the barcodes that will be present on the new labels. He also announced that implanted medical products will also be traced.

The first stage of the implementation of the traceability system, which included the 88 pharmaceutical assets (Prov. 3683/2011), is governed by ANMAT provision 3683/2011 which is still in force. However, this year two further provisions will come into force: No. 1831/2012, which includes 226 pharmaceutical assets and No. 247/2013, which includes nine psychotropic substances. 

 

Plan Remediar

Mauricio Monsalvo, Coordinator of the System of Medical Information and Medication Provisions at the National Ministry of Health is the head of Plan Remediar. This program performs many different functions: it ensures the free provision of mobile medications for people who have mobility difficulties, it regulates demand, implements the coverage of chronic medications, provides distribution services and licenses suppliers, among other tasks.

“We distribute between 18,000 and 20,000 drugs every month to over 7000 different places in the country. And to monitor it, we use a system of delivery notes,” explained Monsalvo, going on to say that “we are seeking to make the inventory system paperless and replace it with an online administration system that centralizes all the information at SISA.”

The Plan is facing a major challenge: to provide greater coverage for healthcare centers across the country. It is thus necessary to ensure that Plan Remediar is vertically integrated throughout the public health system, “To meet these challenges we are going to present a 5 year budget for the incorporation of technology in healthcare centers; this technology includes management and inventory systems and reading technology for hospital pharmacies. For this reason we are going to invest 50 million dollars in two years”, summarized the coordinator.

 

The Data Paradigm: sharing and accessing information

 One thing was clear: everyone agreed on the need to share data. Integration, traceability, electronic records and exchange are just a sample of the different issues that speakers returned to time and again over the three day conference.

Lloyd Mager, Strategic Manager of AbbVie, placed an emphasis on one need: to think about how the information is going to be exchanged. He also explained how the system offered by his company works: “AbbVie is a data exchange platform; the system integrates every serialized product, recognizes events that occur during the registration sequence and provides automatic reports.”

On this point, Thomas Werthwine, Director of Johnson & Johnson, Christian Riediger, Strategic Manager of Bayer Pharma AG, and Margot Drees, Executive Director of Global Healthcare Exchange, emphasized the value of GS1 tools in dealing with data. “Individual organizations can derive many benefits from the implementation of the Global GS1 standard. For example, they can get access to the market and synchronize their data,” said Werthwine, while Riediger provided an example: “DataMatrix is a system that transports data. Currently there are 24 manufacturers of 86 products and over 300,000 coded products.” Finally, Drees noted “EPCIS could be used to exchange data between every participant of the supply chain»».  

Efficiency, Optimization and Traceability

 The leitmotif of the event was to share traceability experiences. Efficiency, optimization and sustainability of the supply chain in the healthcare sector are crucially important in making all medications, implants, and other healthcare products and supplies traceable. The process has only just begun; there is a long way to go.

Related news: Traceability Solutions at the GS1 Global Conference.

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