Toward Global Standards in the Healthcare Supply Chain

In the case of the United States, Merck encodes Cozaar with the National Drug Code (NDC) per FDA regulation. The NDC maps into the Global Trade Item Number.

Medication errors present risks to public and economic health. Counterfeit pharmaceutical products put people’s lives at risk and are an increasing global threat. The need for a traceability solution in healthcare, from point of manufacture to point of care, has never been more important.

Complicating matters are the soaring costs of treating patients. All related stakeholders are looking for more efficient ways of patient care while increasing patient safety. Identifying counterfeit products, faulty batches of drugs, drugs past their expiry date, adverse-event reports, and product recalls accurately and immediately is critical.

NEED FOR GLOBAL STANDARDS

Safety, security, and traceability of pharmaceuticals and medical devices are currently at the forefront of government regulations and industry concerns around the world. As a result, numerous and often irreconcilable national solutions have been developed or are being proposed to the national and international supply-chain stakeholders.

The complexities of the increasingly global healthcare supply chain are vast. Supply chains that deliver healthcare products cross in and out of geographic and political borders, with products changing ownership a number of times. Significant inconsistencies in the amount of legislation, regulation, and resources exist from country to country. These inconsistencies further complicate an already complex distribution system.

The cost of diverse government regulations, proprietary service offerings, and incompatible solutions to all stakeholders is driving demand for global standards in the healthcare supply chain. Because of its ability to provide globally unique identification of items, parties, and locations, the GS1 system of standards is particularly well suited to be used in healthcare. GS1 standards are open, global, and voluntary.

GS1 Healthcare is a voluntary, global healthcare user community bringing together all related healthcare stakeholders: pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies, and associations.

The mission of GS1 Healthcare is to lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply-chain efficiencies.

Healthcare is by nature a global sector, with supply chains that often cross borders. Local needs are incorporated into global standards, but local standards will jeopardize the realization of the related benefits. Local standards hinder interoperability and compatibility, which significantly reduces the economic benefits. Additional R&D and manufacturing resources have to be devoted to meeting heterogeneous local standards.

Open, technology-independent standards permit full interoperability and compatibility. End-users are not locked into proprietary solutions. R&D resources can be freed up for other added-value developments once standards have been adopted.

GLOBAL IDENTIFICATION KEYS, BAR CODES, AND RFID

The GS1 Healthcare AIDC Application Standards work team is developing the global standards for the automatic identification and data capture for healthcare products at all packaging levels from finished goods at manufacture to the end of treatment at the healthcare facility. The team’s work is based on business, data, serialization, and carrier requirements provided by other work teams.

The development of the GTIN Allocation Rules for Healthcare (GTIN: Global Trade Item Number, a GS1 identification key for trade items) was a major accomplishment and provides a global Healthcare-specific reference for consistent and unique identification. (Visit www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf for an update.) The work team is currently drafting the first AIDC Application Standards for a majority of medical product types and packaging levels, targeted for the third quarter of 2008. It will continue in a second phase with the remaining product types and packaging levels, targeted for the second quarter of 2009.

Merck and most manufacturers rely on global and open standards from GS1 for their bar coding needs. The use of linear bar codes is already well established and healthcare users are now looking toward 2-D codes for potential future applications.

GS1 Healthcare advocates the global harmonization of product identification, which should be as ubiquitous in healthcare as it is in the retail sector. A national identification number for automatic identification purposes is not an appropriate solution for the healthcare supply chain. Embedding a national product identification number in a GTIN or developing national requirements to use other prefixes in the GTIN beyond the standard company prefix would negate the benefits of global standardization. It should be avoided.

A standardized system of unique device identifiers (UDIs) will also have to be developed to comply with upcoming regulations. This will enable the development of a UDI database containing, for each product, a minimum data set, including the UDI and the information used to create it, as well as information for safe use (e.g., indications, latex content). In 2007, FDA received about 66,000 medical device adverse-event reports, of which 15% lacked model or catalogue number and 50% lacked lot number or other identifiers. UDIs can improve such reporting. UDIs can also improve medical device recalls. For example, in just one month (March 2007), there were 142 Class II recalls, or 35 million individual units.

TAKING STEPS TO GLOBAL TRACEABILITY

The GS1 Global Traceability Standard is a process standard that defines the traceability business process and the minimum data management requirements for all traceability systems, independently from the technology employed.

The GS1 Healthcare Traceability in Healthcare work team is defining the global solution to ensure that the business needs of the industry are fulfilled, including ensuring global traceability in an efficient, secure, and reliable way; addressing restrictive legal requirements; addressing authentication from manufacturer to patient; and achieving cross-industry interoperability.

Its objectives are in two phases. In Phase 1, the work team developed the Global Traceability Standard for Healthcare. Having finished writing the standard by the end of June 2008; it still needs to be ratified. Phase 2 involves developing by the end of December 2008 an implementation guideline that includes documented case studies and best practices. Phase 1 is complete and the draft Global Traceability Standard for Healthcare is going through the approval process prior to entering global standard management process (GSMP).

A traceability system typically consists of the following building blocks:

• Unique identification of products, logistic units, locations, and assets.
• Capturing and recording traceability data with bar codes or RFID.
• Links management linking in-bound materials through changes to new out-bound traceable items.
• Data communication sharing traceability data between trading partners.

Systems based on this Global Traceability Standard for Healthcare will make it much more difficult for counterfeiters to intrude into the healthcare supply chain. It will also improve the process of recalling products and reporting adverse events.

COLLABORATING WITH (INTER)GOVERNMENTAL BODIES

An actual package for four 2-ml ampoules, demonstrating what happens when individual countries each require their own bar codes and numbers for the same drug. The package already features Data Matrix. Source: Frankie Meuleman, AZ, St. Jan Hospital Brugge, Belgium. (click to enlarge)

The vision of GS1 Healthcare is to be the recognised, open, and neutral source for regulatory agencies, trade organizations, and other similar stakeholders that are seeking input and direction for global standards in healthcare for patient safety, supply-chain security and efficiency, traceability, and accurate data synchronization.

At an international level, GS1 Healthcare is a member of the World Health Organisation IMPACT Work Team « Technology ». (IMPACT is the International Medical Products Anti-Counterfeiting Taskforce.) GS1 Healthcare is working with the Global Harmonization Task Force (GHTF) concerning Unique Device Identification and with the European Commission on the issue of patient safety. The Council of Europe has issued a Medication Safety Report whereby it is recommending global harmonization in healthcare with GS1 Standards.

At a national level, GS1 member organisations, supported by GS1 Healthcare, are working with national decision makers. For example:

• GS1 Healthcare U.S. is providing input to the California State Board of Pharmacy on standardizing the traceability solution to meet the California Pedigree Legislation. FDA representatives are also closely involved in GS1 Healthcare activities, both at a global level for standards development and at a national level.
• In Japan, GS1 Japan worked with the Ministry of Health, Labour, and Welfare (MHLW) and the Japanese Federation of Medical Devices Association (JFMDA) to obtain a revision to the bar code guideline for medical devices. This guideline is now fully harmonized with GS1 Standards, recommending the use of GTINs.
• In the United Kingdom, the Department of Health is recommending that the GS1 System should be adopted throughout the Healthcare system in England and presents an action plan calling for engagement in the GS1 Global Healthcare User Group.
• In Turkey, GS1 Turkey and GS1 Healthcare are working with the Ministry of Health on two projects: the Turkish Pharmaceuticals & Medical Devices National Data Bank (e-catalogue), in order to create a common language to share data electronically between all relevant parties, and a Drug Traceability System, whereby the Ministry of Health will maintain a centralized database to trace pharmaceuticals.
• In New Zealand, the Ministry of Health is funding a Medication Safety Project based on GS1 Standards.
• Developments in other countries include those in Austria (Ministry of Health), Australia (National eHealth Transition Authorities), Brazil (Ministry of Health), Canada (Canada Health, Public Health Agency of Canada), Chile (Cenabast), China (Ministry of Health, SFDA, and the Hong Kong Hospital Authority), France (AFSAPSS), Italy (Ministry of Health), Spain (Regional authorities in Andalucia, Galicia), and many more.

About GS1

GS1 is a neutral, not-for-profit standards organisation. GS1 is a user-driven organization dedicated to the development of global supply chain standards and to the facilitation of adopting and implementing of such standards. GS1 is driven by more than a million companies, which execute more than six billion transactions a day with the GS1 System of Standards. GS1 is truly global, with local member organisations in 108 countries and with global offices in Brussels, Belgium; and Princeton, NJ, USA.

For more information, please visit www.gs1.org or www.gs1.org/healthcare. Please contact the authors at:

Ulrike Kreysa, Director Healthcare
ulrike.kreysa@gs1.org

Jan Denecker, Marketing Manager Healthcare & GDSN
jan.denecker@gs1.org

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