By Rocío Bao
“The fundamental aspect is patient safety and transparency in the sale of medications,” said Estela Izquierdo, the Director of the Hospital Pharmacy Residency at the Sanatorio Güemes during the start of the 4th Conference entitled “Advances and Technical Solutions in the Implementation of the Medication Traceability System,” which took place on the 9th of October at the NH City & Tower Hotel.
Over an intensive nine hour session, leaders from companies and organizations such as GS1, Bayer Argentina, the Favaloro Foundation, the FLENI Foundation, the Argentine Institute of Diagnostics and Treatment (IADT) and Bristol Medicine presented the benefits, advances and problems with the implementation of the National Traceability System (NTS).
Regulatory update on pharmaceutical activity and the responsibility of each of the actors involved
The first presentation was given by the President of the Conference, Estela Izquierdo, who spoke about the current regulations, the inclusion of the provinces in the NTS, the problems that arose during the implementation process (such as illegible labels and unauthorized operators, for example), the objectives achieved (such as 75 million reported transactions) and the role of ANMAT in the process.
Concluding her speech about the application of the system, Izquierdo said: “The value added to each sales chain and the patient is indisputable.”
Remediar+ Redes Program
Mauricio Monsalvo, the coordinator for Medications and Information at the Ministry of Health, focused on public healthcare for the Argentine people. During his presentation, he explained the dynamic of the “Remediar + Redes” program, whose main objectives are to strengthen treatment capacities at the First Level through centralized acquisition and direct distribution of medications, training of human resources in the rational use of medications and equipment and the technologies needed to optimize public healthcare.
“Remediar is a kind of large logistical concentrator of public supply,” he said, going on to discuss the need to consolidate the supply system by strengthening the IT system to meet the traceability regulations and improve processes for receipt, storage and distribution of medications and supplies at the Ministry of Health.
With regard to medications management, the Coordinator of the Remediar Plan spoke about auditing based on GS1 GTSH and the incorporation of standards and recording technology. “We ask the laboratories to only use DataMatrix and GTIN Code,” Monsalvo said.
On this issue, he also noted the provision of optimized and integrated clinical management, pharmaceutical service networks based on APS and URM and TRAPS training and distribution of updated guides, protocols and materials (for prescriptions).
He also referred to the plan for annual distribution in 2012 and said that over 21 million pharmaceutical units corresponding to 199 products were delivered and traced by lot; 1.5 million units were traced by serial numbers for 126 products; 58.6 million outpatient medical consults and 18.1 million covered prescriptions were also traced.
At the end, Monsalvo stated the need to consolidate intergovernmental relations and strengthen the ties between the public and private sectors, saying: “The integration of logistics at the Ministry of Health through Remediar represents an opportunity to manage the supply chain in the public sphere.”
Proper operating strategy: Helios Pharma and Traceability
The Helios Pharma pharmacist, Yanina Sarnagiotto, placed great emphasis on the need to speak the same language with regard to traceability.
“Traceability helped us to develop a sales security department to make things more flexible,” she said, adding: “There are pharmacies in the provinces who aren’t included in the system but that use traceability because they find it convenient.”
Sarnagiotto also noted that they are trying to carry out all operations using the GS1 procedures and outlined the benefits of the verification process using those standards: flexible and secure traceability, administration with logistical unit identifiers, electronic exchange of documents (dispatch notification), and precise delivery to the interior of the country, among others.
Finally, she referred to the measures needed for the implementation of a reliable electronic delivery note and explained that Helios Pharma has its own, non-standardized electronic delivery note with a “TRAE” button. This button allows them to monitor the note, the invoice, the GLN issuer, the GLN receiver and the departure of the stock.
Meanwhile, the Head of Systems at Helio Pharma, Hugo Visciglio announced that one of the company’s objectives for the future is to use electronic commerce (eCom) because it provides benefits such as savings and speed of data entry, reduces human errors, allows for transfer of business data (regardless of internal hardware or software type) and has standardized, scalable systems.
“The major problem in the traceability system lies in inferior standards,” he said. In this regard, he, like Sarnagiotto, recommended that all the actors involved get closer to the GS1 system to facilitate the process and speak the same language.
GS1: moves toward secure identification
The head of Healthcare Development at GS1 Argentina, Mario Abitbol, provided practical advice for the optimization of work through the use of new technologies such as RFID (Radio Frequency IDentification).
He said that it is worth investing in 2D radiofrequency (RF) readers as currently linear readers are proving to be insufficient. He also noted that EPC is a practical RFID application based on the use of global standards.
“RFID and DataMatrix will probably coexist for a long time because companies made a big investment and they’re not going to stop using it from one day to the next. But at some point Argentina will have to migrate toward radiofrequency,” Abitbol warned.
In addition, comparing the situation with other countries, Abitbol said that there hasn’t been a global move by the pharmaceutical industry toward radiofrequency because the level of falsification of medications that occurs in Argentina isn’t present in other countries.
“Working with traceability is a necessity. There is a time for resistance and a time for proposals. If there is a better way to do things, we have to let people know,” Abitbol concluded.
Practical analysis by the Bayer Laboratory
The Systems Manager at Bayer Argentina, Pablo D’amico explained the current organizational structure of the company and spoke about forthcoming challenges.
D’amico said that the serial numbers are generated in Argentina and that at the moment Bayer doesn’t trace locally produced products. Furthermore, he said that only serialization is carried out in Argentina but that the company hasn’t ruled out additions in the future. “Local companies are much better prepared than the multinationals,” he said.
Finally, he announced that the next challenges for the company are related to the implementation of traceability in the production line in China and the implementation of traceability according to SENASA parameters.
IADT and the Favaloro Foundation: Advances in implementation in hospital pharmacies
Guadalupe Fernández Porto, the head of the pharmacy at the Argentina Institute of Diagnostics and Treatment (IADT), explained the stages in the process of traceability, the resources available to implement it and the problems that arise during implementation.
Fernández Porto noted that they currently have a set of ten 2D readers and two wireless readers. They have also acquired traceability software (InfHos), have developed and implemented traceability solutions internally at the IADT, have created GTIN/GLN tables linked to internal codes and carried out modifications with existing interfaces (for consults).
In spite of this infrastructure, Fernández Porto said that there are still certain problems and there is much to be done: “One of the current limitations is the lack of serialization at the single dose level. There is also a lack of proper equipment to automate the process,” she emphasized.
Finally, she said that Resolution 1444/13 is viable if the traceability circuit is complete, reporting to the administration from the bedside, which is the main objective to be achieved.
The head of the pharmacy at the Favaloro Foundation, Bárbara Gueler, said: “What we all want is to get to the patient’s bedside. If the pharmaceutical industry identifies single doses, then we will be able to dispense them at the patients’ bedside.”
FLENI Practical analysis of the FLENI Foundation
Nicolás Viudez, the head of the Oncology department, spoke about the main challenges facing the FLENI Foundation: “We are seeking to implement electronic administration, re-labeling of medications and optimizing SIDCA.”
He also spoke about the need for the intervention of the pharmaceutical industry: “With regard to the re-labeling of medications, the pharmaceutical industry needs to help us.”
At the end of his presentation, Viudez concluded: “It is about dispensing medications conscientiously, knowing that the medication will end up with the patient. I’m not interested in implementing traceability just to meet a dictate from ANMAT but to guarantee their safety.”
