BAR CODING SUPPLEMENT

Bar coding technology has had a significant impact on the retail supply chain. Automatically capturing, storing, and analyzing product identification from the bar code and organizing logistics functions that streamline the flow of information have had significant benefits. Retail industry standards for bar coding have been in existence for decades.

The healthcare industry, however, has been slow to fully embrace bar coding for a number of reasons. From a hospital’s point of view, bar coding was viewed as a purely logistics tool for better supply chain management and cost containment. Secondly, hospitals have been traditionally slow to commit funding to implement technology infrastructure unless there is a guaranteed return on investment. The slowness of the pharmaceutical industry to develop standards for medication marking at the unit level is baffling, as it would enhance the internal and external supply chain with associated benefits for stock management and anticounterfeiting. But looking beyond the supply chain in particular, we find benefits that extend to care-giving functions: the core business of healthcare.

Once a patient’s prescription has been received, all picking, packing, and shipping are performed using bar code scanning for complete product tracking.

Interestingly, when the entire healthcare system works with patients to deliver and track the supply chain of services for wellness, healthcare savings and improved patient health can be achieved. More than just visions of the future, these benefits are already being achieved with suppliers, hospitals, and patients in Ireland.

The Irish Haemophilia project, which uses unit bar codes to manage product and healthcare for all government-sponsored Haemophilia patients, is an example of how bar codes can facilitate the healthcare supply chain. This particular supply chain includes expensive medications, critical storage conditions, short expiration dates, and a special patient concern for product pedigree. Overcoming the challenges in this instance bodes very well for anyone instituting similar programs for their products.

HOSPITAL BAR CODE USE FROM IRELAND

The National Centre for Hereditary Coagulation Disorders (NCHCD), located at St. James’s Hospital (Dublin), manages patients with inherited and acquired bleeding disorders. In Ireland, there are approximately 2000 patients with Haemophilia, approximately 200 of which have severe Haemophilia that requires intensive care and treatment; more than 75% of patients with this severe factor deficiency self-medicate at home.

The medication regimen of a Haemophilia patient includes expensive blood products [coagulation factor concentrates (CFCs)] that require specific cold-chain handling that extends from suppliers all the way to the patients’ homes and product use. Consequently, the value chain in this specific case is directly controlled by a single responsible payer. The NCHCD must directly deliver and pay for wellness. Product that is not delivered or stored appropriately results in either waste (increased costs for product purchased) or sicker patients (increased costs for patient care). As a result, cost savings from efficient delivery directly benefit the NCHCD budget.

Although patient safety depends upon controlling medical errors, in this case it also depends upon the safety of the blood and blood products. This latter issue was brought sharply into focus in the 1980s when patients suffering from Haemophilia became infected with HIV or Hepatitis owing to blood product contamination. The situation was compounded by the fact that infected medication (blood product) remained in the supply chain even after a recall was initiated, leading to further infections. In Ireland, this led to a national tribunal of inquiry (The Lindsey Tribunal), which acted as a catalyst for a unique initiative spearheaded by Barry White, M.D., medical director of NCHCD.

The plan was to apply the retail supply chain model, incorporating unique unit-of-measure bar codes (serialized Global Trade Identification Number [GTIN] according to GS1-numbering standards), to all Haemophilia medication. This would allow electronic track and trace of the product as it moved from manufacturer to the patient (particularly important as the majority of severely affected patients self-medicate in the home).

However, the absence of standardized unit-of-measure bar codes on medication coming from the three main manufacturers (in fact, some of the medication had no bar codes at all) meant that a unique standardized bar code could only be applied once the products reached the cold-chain supply company (TCP Ltd.) contracted by the hospital to deliver it to the patient home.

HOW THE HAEMOPHILIA PRODUCT TRACKING SYSTEM WORKS

Product bar codes are then scanned at hospitals for complete traceability. Waste from poor handling has been eliminated.

St. James’s Hospital adopted the GTIN as part of its solution and implemented linear bar codes for the identification of Coagulation Factor Concentrate (CFC) products. The key objectives of the initiative were to implement real-time identification of CFCs to ensure immediate product recall, optimize stock management, and reduce waste. The unique code allocated to each patient, drug product, and location facilitates the automatic linking and capture of data during the supply process, validating each step of the cold-chain storage and delivery process in real time, ensuring that the correct drug is prescribed to the right patient, and automatically updating the stock management system so that patient consumption trends can be analyzed.

The key to the success of this project involves harnessing the power of bar codes. Each patient is allocated a unique identifier bar code, as are each unit of medication and each location in the supply chain.
The process starts at the cold-chain company where the medication from the suppliers is received. Information on each vial box (product name, expiry date, and batch number) is entered into the handler’s stock management system. A bar coded vial box serial number (VBSN) label is generated and applied to each unit of medication. The medication is then stored in validated cold-chain conditions. Once a prescription is received for a patient or hospital delivery, all picking, packing, and shipping are performed using bar code scanning to track and trace the product as it moves through the supply chain. Within the hospital, a software system then takes over the tracking and tracing of the medication, again based on bar code scanning.

MEASURABLE SUCCESS

The result has been an overwhelming success on a number of fronts. St. James’s Hospital now has total visibility of each unit of medication in the supply chain. A mock recall can identify the location of 100% of the selected batch of product within 10 minutes. Patients are extremely happy with a cold-chain-delivery service they can rely on. Product waste owing to failure of cold-chain conditions or documentation issues has been eliminated. Interestingly, because the patients have confidence in the delivery method, €5 million worth of medication has been removed from the supply chain, most likely because patients no longer “over order” and patient consumption trends are now visible in real time.

THE FUTURE: BAR CODE ADVANCEMENTS

A stock management system implemented at St. James’s Hospital has enabled electronic tracking of coagulation factor concentrates (CFCs).

The use of bar codes in healthcare has advanced considerably with the introduction of two-dimensional (2-D) bar codes. These 2-D bar codes are much smaller than linear bar codes, while at the same time capable of carrying significantly more information. It is the ideal format where the size of the package or vial is small, and the space is not available for printing linear bar codes. This is particularly relevant in healthcare for medication that is administered as a single dose unit within the hospital or the home. For example, the Data Matrix bar code requires the least amount of label space than any other available bar code standard.

Recently, the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced its support for a Data Matrix bar code standard to protect patient safety through a more-transparent medicine supply chain. The structure and content of the proposed bar code is based on a model developed by GS1, Baxter Healthcare, and St. James’s Hospital as part of a proof-of-concept project for medication authentication. If adopted throughout the healthcare system, pharmaceutical companies will, in time, have the capacity to locate and track each dose of medication produced as it moves through the supply chain to the patient by providing an accurate drug pedigree that is a secure record documenting the drug’s source and date of manufacture.

Once standards have been adopted by all participants in the healthcare distribution system, the power of the EPCglobal Network can be leveraged. The drug track-and-trace system can use EPC (electronic product code) technology, which assigns a unique number to every single item that rolls off a manufacturing line, allowing every company in the supply chain to track products at the individual item-of-use level. As a product moves through the supply chain, manufacturers, trading partners, and regulators all have access to key data, which become invaluable when addressing issues such as product recalls, product authentications, or defective ingredients, which, in the case of haemophiliacs, can mean life or death.

PATIENT HANDHELD DEVICES AND POINT OF CARE

Extending the concept of traceability to drug administration at the bedside and within the patient home will provide the final piece of the jigsaw puzzle. The bar code serves as an index key in clinical databases. At the time that a medication is administered, bar codes can be used to identify the drug, patient, and/or the person administering the drug. This will ensure a match between the patient and their prescribed medication and also identify who is administering the medication. The system can be linked to software that references information in the electronic patient record (EPR) to comply with the “Five Rights” of patient medication administration: ensuring the right drug is administered, at the right time, to the right patient, in the right dose, by the right route. However, the technology needs to be easy to use and easily portable so that the caregiver can move around the hospital freely without the technology becoming burdensome.

The Irish initiative should help encourage the pharmaceutical and healthcare industries to move forward with a unit-level bar code standard for medication. Once they have achieved a standard, increasing numbers of medication administration applications and EPR systems will begin supporting it, which, in turn, will allow heathcare systems to save money while delivering better patient care.