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Jan 27 2021

2D Barcoding is a Legal Requirement for Pharmacies - and PrimeRx™ makes Compliance Fast and Easy

When the U.S. Congress passed the Drug Supply Chain Security Act (DSCSA) in 2013, the underlying goal was to build a network to identify and trace certain prescription drugs as they were distributed throughout the United States. Technology, of course, was always intended to be an integral part of the new network, as stakeholders across the health care industry worked to improve visibility within the nation's drug supply, and protect U.S. consumers from potentially dangerous drugs.

The DSCSA, which is actually a subsection of the larger "Drug Quality and Security Act" (DQSA), outlines requirements for creation of an electronic system to track and trace prescription medications. The Act outlines requirements for all stakeholders - manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and logistics providers.

With regard to pharmacies, core responsibilities include:

  • Confirmation that all trading partners are properly licensed and/or registered.
  • Creating a system to receive, store and provide product tracing documentation. Under the law, pharmacies may only accept prescription drugs that are accompanied by three pieces of product tracing documentation:
    • Transaction Information: Includes the name of the product, strength and dosage form, NDC, container size, number of containers, transaction date, shipment date, name and address of the seller and buyer, and lot number.
    • Transaction History: A statement in paper or electronic form that includes information for each prior transaction going back to the manufacturer of the product.
    • Transaction Statement: A statement, in paper or electronic form, that affirms the legitimacy of the transaction.
  • Investigate and properly handle suspect and illegitimate drugs.
  • Use of "unique identifiers." Beginning in 2017, manufacturers and repackagers were required to print or affix a unique product identifier on the smallest individual sellable unit. The product identifier must be "human and machine readable," with a two-dimensional (2D) barcode adopted as the standard for machine processing. The product identifier is composed of four specific data elements:
    • National Drug Code
    • Serial number
    • Lot number
    • Expiration date.

For pharmacies, the use of 2D barcode scanning as a way to verify product authenticity was initially optional. But as of November 2020, 2D barcode scanning is now mandatory.

What are 2D barcodes?

2D barcodes can hold a significant amount of information, and can remain legible even when printed at a small size or etched onto a product. According to the Centers for Disease Control (CDC), the barcodes allow health care providers, including pharmacists, to easily capture the four components of a product's unique identifier (National Drug Code, serial number, lot number, expiration date).

What are pharmacies' responsibilities with regard to 2D barcodes?

Pharmacists must scan the 2D barcode when entering products into inventory, and again when dispensing to patients.

How can PrimeRx™ users integrate 2D barcode scanning functionality?

Several upgrades have been made to the PrimeRx™ pharmacy management system to allow pharmacies to easily accommodate 2D barcodes. While PrimeRx™ continues to also support traditional 1D barcode scanning, the system accommodates 2D barcodes in several ways that include:

  • The "drug lot number" and "expiration date" fields are automatically filled, eliminating the need for pharmacists to manually enter this information.
  • The system automatically detects incorrect barcodes during its verification process.
  • The system will update existing lot number and expiration date information to include new values included in a 2D barcode scan.
  • A user can scan 2D barcodes to search a drug file.
  • 2D barcode data is seamlessly added to a patient's file, for updated immunization recordkeeping.

What are the benefits of 2D barcodes?

Compliance with the federal Drug Supply Chain Safety Act is an obvious benefit to pharmacies, since as of November 2020, the use of 2D barcodes is no longer optional. But there are several other benefits, that include:

  • Elimination of time-consuming manual entry, and minimized risk of errors occurring during the inputting process.
  • Easier identification and removal of products when they reach their expiration dates.
  • Enhanced patient safety, as pharmacies are able to better identify recalled products and ensure product authenticity.
  • Enhanced patient data. PrimeRx™ users can rely on the seamless integration of 2D barcode data.
  • Better inventory management as pharmacies can monitor supplies of drugs and forecast expected demand. Enhanced inventory management also allows pharmacies to minimize the risk of maintaining excessive - and costly - levels of products.

Barcode scanning tips

The American Pharmacists Association (APhA) offers a list of barcode scanning practices, as outlined by the Institute for Safe Medication Practices:

  • Ensure barcode scanning is used consistently and as intended each time a medication is dispensed, including refills and owed quantities.
  • Always scan the barcode printed from the pharmacy computer system and  the barcode on the medication product being dispensed.
  • Avoid verifying product selection by typing the NDC number from the patient's label or the computer screen, as this undermines the system safeguards.
  • If you must type the NDC number because the bar code won't scan, type it from the medication products.
  • During order entry, either type the drug name and strength or use the computer system's drug look-up feature. Do not first retrieve the product from storage and scan the barcode as a way of entering the drug; if the wrong product is selected from storage, there will be no opportunity to catch the error later in the dispensing process by scanning the barcode.
  • When more than one stock bottle is needed for a specific drug quantity, scan each stock bottle. If more than one container will be dispensed, ensure that each one has a pharmacy-generated label.
  • Scan each medication for product verification. For example, dispensing three albuterol inhalers should require three individual computer-generated labels and the scanning of each albuterol inhaler package barcode.
  • Invest in barcode scanners that can read at least 90 percent of bar codes and all symbols used by pharmaceutical manufacturers.
  • Never bypass the bar code scan in the interest of delivering the prescription more quickly.
  • If a mismatched scan is identified, investigate the cause.

In addition to being a legal requirement, 2D barcodes help ensure efficiency and accuracy in the prescribing process. PrimeRx™ facilitates the scanning process, and ensures pharmacies take full advantage of the valuable information each bar code includes.