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In 2004, the US Food and Drug Administration (FDA) issued a new rule making it a requirement for most prescription products to carry bar codes down to the dose level. However, the FDA did not enforce any standards, nor did it require manufacturers to include expiration dates or lot numbers. In 2010, the American Society of Health-System Pharmacists (ASHP) published a draft version of its statement on bar codes1 and put into place a centre that would accept reports of bar-coding problems.2 Health Canada has not yet adopted mandatory bar coding for drugs, but earlier this year, the Institute for Safe Medication Practices Canada and the Canadian Patient Safety Institute jointly endorsed the adoption of the GS1 global standard for automated identification of pharmaceutical products in Canada.3,4
In Canada, the pharmaceutical industry uses both Universal Product Code (UPC) and Global Trade Identification Number (GTIN) symbologies for bar-coded drug identification. The GTIN, which refers to a family of GS1 global data structures, employs 14 digits and can be encoded into various types of data carriers. The GTIN is compatible with existing standards such as the UPC and does not place any additional demands on scanning hardware.5 The GS1 DataBar symbology requires that the GTIN be preceded by an application identifier, for a total of 16 digits.
At the Centre hospitalier universitaire Sainte-Justine (CHUSJ), we have been using bar codes for many years, mainly for inventory management. Recently, we explored the concept of numeric identity for pharmacy products, whereby all relevant information for a given drug would be grouped within a single database (e.g., drug numbers, including applicable bar-code numbers; drug description; drug characteristics; drug images)6 that can support the various software programs used throughout the medication-use process. We tested this “proof of concept” and implemented a web-based page to support our daily compounding production of nonsterile oral products with bar codes.7 Inspired by the Canadian Pharmaceutical Bar Coding Initiative, we revisited our bar-coding strategies.
First, we applied for advanced membership in GS1 Canada (at a cost of $750). This allowed us to obtain our own 5-digit identifier for the CHUSJ Pharmacy Department. Any locally generated bar codes containing this identifier should be readable and interpretable both inside and outside our organization.
Second, we evaluated the feasibility of modifying our existing bar codes (e.g., 6 digits in code 39 symbology) to numbers of 16 digits or more, to comply with GS1 requirements. This would include redesign of our printed labels and the use of new printers for higher resolution.
Third, recognizing that the department produces not only drug doses, but also various types of drug information (e.g., drug labels, medication administration reports, preprinted orders), we decided that any information produced by the Pharmacy Department should also have a meaningful bar code.
Fourth, we explored the potential of automated identification.8 To attribute meaningful data encoded within a bar code, an automated identification prefix code can be applied. Aside from denoting the meaning, the prefix indicates the format of the data that follow. Automated identifiers are available for identification, traceability, dates, quantity, locations, and other variables. Although our initial objective was to use automated identifiers to capture expiration dates and lot numbers, we realized that it would be difficult to determine applicable expiration dates once labels had been printed. Therefore, we decided to use a serialization number matching our production number, since the serialization number refers to a complete set of data in the relevant database.
We completed our analysis by determining a GTIN toponymy with and without additional automated identifiers. For instance, 16-digit GTIN bar codes will be used for local unit-dose packs, and longer bar codes, with additional automated identifiers, will be used for printed labels or reports related to individual orders on medication administration records and nonsterile compounded doses.
Let’s take an example of the potential benefits of such a system. An order is validated by a pharmacist, and a drug label with a bar code is printed from the pharmacy information system. The bar code contains a GTIN plus a production number. That production number refers to a specific patient and a specific drug service in the pharmacy information system. The printed label is taken to the sterile room where it is scanned and associated with the UPC/GTIN bar code printed on the commercial antibiotic vial used. When the syringe containing the compounded product is ready, the drug label is scanned again and an alert is displayed on the dashboard of the unit coordinator, indicating that the medication is ready to be picked up by a nurse at the pharmacy. It is known that the antibiotic syringe should be administered to the patient within 12 h. However, nobody comes to the pharmacy to pick up the syringe within the expected timeframe. The syringe is retrieved much later, and the label is scanned before the drug is administered to the patient. The bar-code reader displays an alert, indicating that the compounded product in the syringe has expired and should be discarded.
For some, it may seem too early to begin reflecting on optimal practices for hospital pharmacy bar-coding, given that Canadian standards are still emerging. We believe it is time to evaluate and share our experiences with this technology.