BCMA Optimization Playbook

Optimizing Barcode Medication Administration (BCMA) Systems

The information contained in this toolkit is constantly evolving because of ongoing research and improvements in technology and is subject to the professional judgment and interpretation of the involved health care professionals. The ASHP Research and Education Foundation (ASHP Foundation), the expert panel, authors and external peer reviewers have made reasonable efforts to ensure the accuracy and appropriateness of the information presented. However, any reader of this information is advised that the ASHP Foundation, the expert panel, authors and the external reviewers are not responsible for the continued currency of the information, for any errors or omissions and/or for any consequences arising from the use of the information in the toolkit in any and all practice settings. Any reader of this document is cautioned that the ASHP Foundation makes no representation, guarantee or warranty, express or implied, as to the accuracy and appropriateness of the information contained in this toolkit and will bear no responsibility or liability for the results or consequences of its use.

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  1. General Guidance

  2. ASHP Statement: Bar-Code Verification during Inventory, Preparation, and Dispensing of Medications (2011)

    ASHP Statement: Bar-Code-Enabled Medication Administration Technology (2009)

    A Safe Practice Standard for Barcode Technology (2015)

    Pharmacist’s Toolkit for Implementing Barcode Medication Administration

  3. Work-Arounds

  4. The use of work-arounds is one of the greatest challenges to optimizing BCMA systems. In order to address work-arounds effectively, informatics leaders have to understand the types that occur, their causes, and their implications. Resolving undesirable outcomes of work-arounds will be institution and system-specific. System performance data can be used to identify the areas in which system modifications might have the biggest impact to reduce work-arounds.

    Types, Causes, and Implications

    Barcode Medication Administration Systems: Their Occurrences, Causes, and Threats to Patient Safety (2008)

    BCMA Factors influencing bar-code verification by nurses (2008)
    Compliance rates and reasons why BCMA verification are described in this article. Barcode verification rates were significantly influenced by difficulty in scanning barcodes, lack of awareness of barcodes on medication labels, software response times, time and staffing constraints.

    BCMA Characterization of High Alert medication triggers and clinician workarounds (2011)
    This study utilized a combination of retrospective analyses and direct observation to identify alert triggers generated by a BCMA system. Findings included failure to document override reasons for 77% of alert messages and 468 directly observed workarounds during 121 administration attempts over a 6 hour period.

    Scanner Beep Only Means the Barcode Has Been Scanned (2011)
    This Institute for Safe Medication Practices’ medication safety alert discusses how audible barcode scanner beeping sounds have mistakenly led nurses to rely on the sound of the beep alone to signal verification of the patient and medication, particularly if the eMAR is not visible during the actual scanning process. This has led some hospitals to disabling the audible beep on the BCMA scanners.

    BCMA Nurse Workarounds in a hospital using BCMA (2012)
    This study analyzed nurses’ workarounds in an academic medical center using barcode medication administration technology. Nurse focus groups and a survey were used to determine the frequency and potential causes of workarounds. The results of this study can provide insights to proactively minimize the use of workarounds in practice.

    Barcode Medication Administration: Lessons Learned from an Intensive Care Unit Implementation (2005)
    This evaluation identified a number of reasons for lack of acceptance and workarounds following a BCMA implementation in a 10-bed intensive care unit, including a lack of functionality related to the documentation of intravenous fluid administration and the need for immediate software access for documentation of medication administration in emergency situations. Subsequently, a multidisciplinary group was convened to facilitate the resolution of issues related to the use of BCMA for the safe administration and documentation of medications prescribed for patients following open-heart surgery.

    BCMA Nursing workarounds for executives (2013)

    An important lesson learned from this review is that healthcare technology, including BCMA systems, should be user friendly while mitigating the risk of committing preventable medication errors. Ensuring that point-of-care staff is aware of the benefits of new systems and processes will increase the likelihood of adoption of new technology. This article provides a systematic review of the literature associated with barcoded medication administration and workarounds and suggests interventions that should be adopted by nurse executives to ensure medication safety.

    Managing and Mitigating Risks
    To improve BCMA implementation outcomes, informatics leaders need to understand the types of workarounds that occur, their causes and implications, and how to effectively manage and mitigate risks. Risk mitigation strategies and solutions for resolving workarounds are often generalizable regardless of the technology or vendor. Metrics must also be used to identify, manage and minimize the risk of negative events and unintended consequences from BCMA. The data generated by the new system hold are critical to improving compliance and optimizing the use of the newly implemented technology. BCMA system data should be reviewed on a regular basis and health-system leaders must establish cultures of staff accountability for the reported information.

    BCMA risk management (2008)

    How do Interruptions Impact Nurses’ Visual Scanning Patterns When Using Barcode Medication Administration Systems?(2014)

    Bar-Coded Medication Administration Brings Trade-Offs Even with Humane Automation and Lean Approaches (2014)   Medication administration errors made by nurses reflect the level of pharmacy administration and hospital information infrastructure (2014)

    Effect of the Implementation of Barcode Technology and an Electronic Medication Administration Record on Adverse Drug Events (2016)

    Medication Errors Occurring with the use of BCMA (2008)
    This advisory from the Pennsylvania Patient Safety Authority provides strategies to optimize medication safety with the use of BCMA.

    Evaluation of Nurse Interaction with Bar Code Medication Administration Technology in the Work Environment (2007)
    The objective of this study was to further understand nurses’ use of BCMA technology, particularly from a human factors viewpoint. Researchers developed an observation method that focused on the interaction between nurses and BCMA and utilized their findings to help improve compliance outcomes.

    Raising the Bar: Using Data from Bar Code Medication Administration to Improve Care (2010)

    This presentation discusses:
    • Differences in BCMA data
    • A process to use data to identify opportunities for improvement
    • Resources needed to maintain and monitor BCMA systems

    Scanning for Safety: An Integrated Approach to Improved Bar-Code Medication Administration (2011)
    This paper describes how a health system created a multidisciplinary team of BCMA stakeholders to review every step of the BCMA process following implementation. Technology, process, and educational solutions were identified and implemented resulting in significant increases in barcode compliance.

    Using bar-code technology and medication observation methodology for safer medication administration (2007)
    The direct-observation methodology was used to monitor medication administration before and after the deployment of the EMAR and BCMA systems. A 54% reduction of medication administration errors was observed following implementation of a multidisciplinary, collaborative approach to medication safety.


Leveraging and Optimizing the Barcode Beyond Point of Care Medication Administration

The deployment of BCMA during the administration phase of the medication-use process has proven to be a valuable last line of defense for reducing the potential of drug administration errors in health systems. The effects of barcodes on patient safety as well as their relative ease of implementation, demonstrated return on investment, and adaptability have prompted healthcare leaders and professional organizations to advocate for implementing barcode technology across the medication-use process and continuum of care.

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  1. Sterile IV Preparation: Will barcode verification technology solve medication identification in the clean room?

  2. Accidents Still Happen: Overview of Current Initiatives for Ensuring the Safety of Compounded IV Medications (2012)
    This presentation provides an overview of how emerging technologies including IV robotics and IV workflow management systems can leverage barcode verification in the sterile products preparation area. The use barcode verification systems for IV product selection, preparation, checking, delivery and administration are discussed.

    Telepharmacy and bar-code technology in an IV chemotherapy admixture area (2009)
    This report describes how telepharmacy and bar coding provided a means to improve the accuracy of chemotherapy preparation by decreasing the likelihood of using the incorrect product or quantity of drug. The system facilitates the reading of small product labels and removes the need for a pharmacist to handle contaminated syringes and vials when checking the final product.

    Sterile product compounding using an IV compounding workflow management system at a pediatric hospital (2014)
    Implementation of an IV workflow management system that integrates barcode verification, automated calculations, and image-capture capabilities led to increased detection of errors in the sterile product compounding process.

    Asynchronous Validation and Documentation of Sterile Compounding in a Hospital Pharmacy (2010)

    Optimizing IV workflow (2013)

  3. Dispensing

  4. Barcode scanning of medications during the dispensing process provides a reliable method to verify that the medication, strength, and dosage form selected from storage to ensure that the prescribed medication is dispensed.

    Medication Dispensing Errors (2006)
    This research demonstrates how barcode technology in the hospital pharmacy may substantially reduce serious dispensing errors including those that frequently harm patients: wrong medication, wrong dose, or wrong formulation errors. If optimally configured, this technology may be an important addition to the medication use process safety arsenal.

    Effect of Bar-code Technology on the Incidence of Medication Dispensing Errors and Potential Adverse Drug Events in a Hospital Pharmacy (2005)
    This study, which evaluated the effect of barcode technology on medication dispensing errors and potential adverse drug events in an academic medical center pharmacy department, found that barcode technology significantly reduced the rate of dispensing errors.

    Effects on a Direct Refill Program for ADC's on Medication Refill Process (2012)
    This evaluation describes how a health system redesigned their ADC refill process using a wholesaler-to-ADC direct refill program that included delivery of prepackaged medication. Barcode-assisted refill significantly decreased the occurrence of ADC refill errors.

    Implementing a bar-code assisted medication administration system: Effects on the dispensing process and user perceptions (2014)

  5. Medication Delivery

  6. Implementation of a Web-Based Medication Tracking System (2012)
    This article describes how a large hospital evaluated the implementation of a web-based electronic tracking system involving sequential barcode scanning and real time monitoring of the medication delivery status process.

  7. Clinical Decision Support

  8. BCMA Effectiveness of Barcode Medication Alerts for Increased Potassium (2012)
    This study evaluated the use of a series of alerts, designed within the framework of a BCMA system, to help prevent life-threatening complications of hyperkalemia by adding an additional layer of clinical decision support.

    The following presentations and articles provide perspectives on why integrating BCMA and intelligent infusion pump technologies is important, including:
    • The pump alone does not perform all of the 5 Rights
    • The pump does not contain the patient ID or caregiver ID
    • BCMA helps establish the relationship between the pump, patient, order, and caregiver
    • Auto programming of the pump can be achieved
    • Reports on infusion data aggregated from the pump server are more useful when associated with a specific patient
    • Electronic charting to the eMAR and in/out flowsheet is achievable when the patient-pump relationship is established.
    • Real-time dashboards, including infusion and patient information, can be provided to clinicians
    • Consistent workflows can be established for all medications including infusions

    The Role of Bar Coding and Smart Pumps in Safety (2008)

    Smart Pump BCMA Integration (2008)

    Integrating Technology to Improve Medication Administration (2011)

    Impact of Traditional and Smart Pump Technology on Administration Performance (2010)
    An assessment of the impact of infusion pump technologies on nurses' ability to safely administer intravenous medications was conducted. The authors concluded that soft limits in intelligent infusion pumps had no significant effect in preventing dosing errors. However, when intelligent infusion pump technology is enabled through the use of barcodes and integrated with other systems within the medication administration process, their role in enhancing patient safety will be improved dramatically.

  9. Utilizing the Barcode across the IV Drug Delivery Platform

  10. A Futuristic Look at BCMA, Positive Patient ID, and Intelligent Infusion Devices (2008)
    This presentation discusses how adding the five rights to intelligent infusion devices can be challenging it can more importantly lead to the holy grail for BCMA and 2D integration “automated pump programming from the pharmacy-reviewed physician's order"

  11. Other Settings and Processes

  12. Perioperative Care
    A Point of Care Medication Bar-Coding System in Operating Rooms for Drug Dispensing, Labeling, and Administration Verification during Anesthesia (2011)

    Bar-Code Scanning Can Fix ‘Black Hole’ of OR Drug Safety (2012)
    Development and evaluation of a barcode-enabled verification tool for anesthesia care providers throughout medication use process is described. Project objectives were to develop a solution that would be easily scalable to large and small hospitals, readily accepted by care providers, and considered successful in improving overall medication workflow.

    Increase OR Safety with Automated Inventory and Labeling (2014)
    This article describes how the use of bar coding and automated dispensing technologies for perioperative medications could be positively identified prior to administration within the anesthesiologist’s workflows.

    A System for Anesthesia Drug Administration Using Barcode Technology: The Codonics Safe Label System and Smart Anesthesia Manager™ (2015)

    Nuclear Pharmacy
    Minimizing human error in radiopharmaceutical preparation and administration via a barcode-enhanced nuclear pharmacy management system (2012)
    This evaluation was performed to ensure correct radiopharmaceutical administration through the use of a barcode system that linked patient and medication profiles with on-site information management systems.

    Compounding & dispensing errors before and after implementing barcode technology in a nuclear pharmacy (2012)
    The objective of this study was to determine whether the incidence of compounding and dispensing errors changed significantly in a nuclear pharmacy after the pharmacy adopted a barcode system.


Best Practices, Process Improvement, and Optimization

The use of more mature and integrated software, better hardware options, and lessons learned from the field have helped to generate iterative improvements to BCMA systems. The following sections identify some resources for developing best practices and optimizing existing systems.

Barcoding to enhance patient safety (2005)

BCMA Scanning Stars: A Sustainable Best Practice: A Sustainable Best Practice (2014)

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General Best Practices for Successfully Implementing a BCMA System
ASHP Statement: Bar-Code Verification during Inventory, Preparation, and Dispensing of Medications (2011)

ASHP Statement: Bar-Code-Enabled Medication Administration Technology (2009)

Fifteen best practice recommendations for bar-code medication administration in the Veterans Health Administration (2004)

Implementation of Bar-Code Technology and Case Studies: Using Technology to Improve Patient Safety (2007)

Best Practices Involving On-Site Barcoded Packaging

Unit dose packaging is a vital technology for pharmacies supporting a BCMA system. However, despite improvements in the ability to purchase barcoded medications in unit dose packaging, hospital pharmacies struggle with labeling syringes, ampules, inhalers, and other difficult to barcode items. The following references identify strategies for assessment of in-house unit dose packaging and discuss various packaging models, technologies, and staff and facility requirements for in-house packaging.

Facilitating the Use of Barcoding for the Successful Closed-Loop Medication

Management System (2009)

Drug Cross-Contamination of Barcode Unit Dose Repackager in a Tertiary Academic Medical Centre (2014)

Impact of Bar-code Medication Administration on Medication Administration Best Practices(2015)

Best Practices and Quality Controls for Improving Barcode Labeling and Scanning
BCMA nursing efficiency (2011)

BCMA Barcode scanner process improvements (2011)

Printing
There are options for overcoming pharmaceutical manufacturers’ incomplete barcode labeling. These include both manual and automated on-site packaging, overwrapping, and on-demand barcode printing capabilities. Hospital pharmacies typically use thermal printers as the foundation for in-house barcode labeling. Thermal barcode printers currently support all pharmaceutical barcode formats and data options, and they produce high-quality symbols appropriate for vials, syringes, ampules, IV bags, tablets, and other medication forms. Typically they can be integrated with legacy pharmacy information systems and may not have to be replaced as additional applications and systems evolve.

BCMA Pharmacy Printers (?)

Considerations for Selecting a Barcode Scanner when Implementing a BCMA System
There are numerous factors to consider in selecting a barcode scanner. The following provide an overview of some considerations.

BCMA scanner best practices (2010)

BCMA choosing barcode readers for pharmacy packaging (2011)

Nursing Devices
The use of computers on rolling carts or stands, handheld scanners, and in-room bedside computers are the most common and currently preferred scanning approaches for a BCMA system. While the use of in-room computers has increased in hospitals over 400 beds, workflows and processes have yet to normalize.

BCMA evaluation nursing mobile devices (2012)

Early nursing involvement for introducing new technologies (2009)

Mobile point-of-care documentation (2012)

Maintaining Best Practices
Maintaining the integrity, quality, and accuracy of medication-related data and information in a BCMA system is essential for the technology and supporting devices to function effectively. This requires that a pharmacy formulary database and other types of databases (e.g., a database of users, barcodes, and dosage forms) be built and meticulously maintained. However, rarely are the systems and devices integrated effectively enough to provide total database synchronization. This makes the development of systems and processes to manage database synchronization challenging. In order for health systems, facilities, and pharmacies to effectively optimize BCMA systems, it is crucial to develop workflows and processes to track and report scanning failures and maintain the integrity and synchronization of all barcode data and databases. The following resources address those issues.

BCMA adapting pharmacy workflow for BCMA (2008)

BCMA and Formulary Interoperability Webinar (2012)

BCMA Formulary Management (2012)

BCMA A Systems Perspective (2008)


Ongoing Challenges and Barriers

Despite the efforts of medication safety advocates, professional organizations, health systems, informaticists, healthcare workers, and the FDA through its regulations and guidance, challenges and barriers persist with BCMA systems. Many of these can be addressed through continuous quality improvement efforts, evaluating the evidence and results, and awareness of work-arounds during BCMA system implementations. This section lists resources about BCMA system experiences, some lessons learned, and ongoing challenges that various healthcare organizations have faced.

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General Lessons Learned

    BCMA General Lessons Learned (2009)

    New Nursing Work and BCMA (2012)

  1. Unique Challenges

  2. Resolving Barcode Issues

    BCMA resolving barcode issues (2009)

    Pharmacy Workflow, Managing Difficult Barcode Products, Packaging, and Database Synchronization
    Adoption of a BCMA system is a multidisciplinary implementation process. A key component for success is to project the resources required to package and label unit doses on-site and to ensure accurate barcoding. Also important is estimating the number of pharmacists and pharmacy technicians required to sustain the additional work. The resources below may help to estimate the resources required.

    BCMA Packaging Issues and Challenges (2013)

    BCMA Challenges (2008)

    BCMA Formulary Database Synchronization (2011)

    BCMA formulary review (2013)

    Challenges with implementing BCMA in the ER (2013)

    Effect of Barcode-Assisted Medication Administration on Emergency Department Medication Errors (2013)

    Including Emergency Departments in Hospital BCMA System Implementations (2012)

    BCMA Addressing challenges in barcode scanning of LVP's (2011)

    Preparing challenging medications for barcode scanning (2015)

  3. Successes, Value, and Cost

  4. Improvements in medication error rates following the implementation of BCMA systems have been encouraging. Numerous organizations have experienced operational and safety successes, value, and process improvements from BCMA systems.

    Medication Administration Error Rates at the Point of Care

    Impact of BCMA on Medication Errors and Patient Safety: A Summary (2009)

    Barcode Medication Administration: Lessons Learned from an Intensive Care Unit Implementation (2005)

    Effects of Bar Code-Assisted Medication Administration (BCMA) on Frequency, Type and Severity of Medication Administration Errors: A Review of the Literature (2012)

    Effect of Bar-Code-Assisted Medication Administration on Medication Administration Errors and Accuracy in Multiple Patient Care Areas (2009)

    Effect of Bar-Code-Assisted Medication Administration on Medication Error Rates in an Adult Medical Intensive Care Unit (2009)

    BCMA Effect of Bar-Code Technology on the Safety of Medication Administration (2010)

    Bar Code Technology and Medication Administration Error (2010)

    Severity of Medication Administration Errors Detected by a Bar-Code Medication Administration System (2008)

    Nursing Efficiency, Workflows, Perceptions, and Attitudes
    Numerous reports and investigations have been published and presented discussing the impact and interaction of BCMA systems with nurses. Users inevitably develop work-arounds for ineffective or inefficient systems. The size and portability of equipment and ease of use is important.

    Nurses’ Perceptions of a (BCMA) Bar-coded Medication Administration System (2011)

    Impact of Barcode Medication Administration Technology on How Nurses Spend Their Time on Clinical Care (2006)

    Bedside Barcode Technology: Impact on Medication Administration Tasks in an Intensive Care Unit (2012)

    That’s Nice, But What Does IT Do? Evaluating the Impact of Bar Coded Medication Administration by Measuring Changes in the Process Of Care (2011)

    Descriptive Analysis of Workflow Variables Associated with Barcode-Based Approach to Medication Administration (2011)

    Effect of Bar-Code-Assisted Medication Administration on Nurses’ Activities in an Intensive

    Care Unit: A Time–Motion Study (2011)

    Effect of Barcode Technology with Electronic Medication Administration Record on Medication Accuracy Rates (2014)

    The expectations of nurses about the implementation of a Barcoded Medication Administration System: a qualitative study (2014)

    Pediatric medication administration errors and workflow following implementation of a bar code medication administration system (2014)

    Analysis of the Technology Acceptance Model in Examining Hospital Nurses’ Behavioral Intentions Toward the Use of Bar Code Medication Administration (2015)

    Creating a Culture of Safety Around Bar-Code Medication Administration: An Evidence-Based Evaluation Framework (2016)

    Costs Associated with Barcode Systems

    The Cost of Implementing Inpatient Barcode Medication Administration (2013)

  5. Leveraging Auto-ID Technologies Beyond the Barcode: can RFID help?

  6. Despite their high degree of readability, barcodes, particularly linear barcodes, present many challenges including: requiring line of sight, aiming, real estate requirements, encoding restrictions and the use of two hands by the nurse. RFID technology may be beneficial in reducing some problems associated with implementing and adopting BCMA systems.   Augmenting the BCMA process with RFID tags for caregiver and patient verification as well as other problem prone areas such as IV bag identification may lead to optimized BCMA compliance.

    The use of RFID technologies in healthcare systems today is modest, primarily due to cost. Despite the fall in RFID unit costs within the past few years, they have yet to achieve the “tipping point” of economic practicality for healthcare organizations. RFID in healthcare has been restricted to primarily asset management and supply chain applications. The following references provide a sampling and an overview of implications and applications of RFID technology in healthcare systems and pharmacies today.

    Patient Safety Applications of Barcode and RFID Technologies (2013)

    North Carolina Hospital Identifies Recalled Drugs via RFID (2013)

    Efficiency and Usability of a Near Field Communication-Enabled Tablet for Medication Administration (2014)

    Radio Frequency Identification (RFID) in Health Care: Privacy and Security Concerns Limiting Adoption (2014)

  7. Regulation and Policy

  8. Meaningful Use, Stage 2 Provisions under the Health Information Technology for Economic and Clinical Health Act

    On September 4, 2012, the Centers for Medicare and Medicaid Services (CMS) published a Meaningful Use Stage 2 rule under the Health Information Technology for Economic and Clinical Health Act. The rule was set to become effective in 2014 and provided a flexible reporting period for 2014 to give providers sufficient time to adopt or upgrade to the electronic health record (EHR) technology certified for 2014.

    After its inception in 2009, the meaningful use program financially incentivized health systems to invest in information technology and implement core medication-use-process supporting systems within the framework of an EHR. The CMS meaningful use program was divided into three stages:

    Stage 1 - set the basic functionalities that EHRs must include such as capturing data electronically and providing patients with electronic copies of health information.

    Stage 2 - (scheduled to begin in 2014) increased health information exchange between providers and promoted patient engagement by giving patients secure online access to their health information.

    Stage 3 - was intended to expand meaningful use objectives to improve healthcare outcomes.

    The stage 2 rule played a significant role in motivating healthcare organizations to adopt BCMA technology by requiring that 10% of medication orders be tracked in electronic medication administration records (eMARs) that automatically document the administration of medication into certified EHR technology using "assistive technology" - for example RFID or electronically readable tagging such as barcoding.

    The financial incentives and the prospect of losing CMS reimbursement and incurring eventual penalties likely will serve as a tipping point for reaching wider BCMA system adoption. The 10% barcode threshold in stage 2 enabled hospitals to implement eMARs in a limited way without incurring significant expense and, according to CMS, provided a realistic and achievable target. However some patient safety experts and healthcare organizations believed the threshold to be too low and that it might lead to flawed implementations and unintended and unsafe consequences. To aid healthcare organizations to better understand stage 2 meaningful use requirements, resources have been developed.

    Raising the Bar Code Requirement? (2013)

    The Next Stage for BCMA (2012)

    Eligible Professional (EP) Meaningful Use Core and Menu Measures Table of Contents (2012)

    Sequencing of EHR adoption among US hospitals and the impact of meaningful use (2014)

    Barcode Label Requirements
    FDA guidance for industry barcode label requirements (FDA guidance)

    Bar Code Label Requirements Questions and Answers (2011)

    FDA: Bar Code Label Requirements

    How Will Other Legislative Policies Affect BCMA?

    Food and Drug Administration Safety and Innovation Act (FDASIA)
    FDA Safety and Innovation Act (July 9, 2012) (federal law). Although the purpose of this legislation was primarily to re-authorize user fees for medical devices and biologics, it contained provisions that included (a) a deadline for the FDA to establish a unique device identification (UDI) system for medical devices and (b) new authorities for the FDA to address the challenges posed by an increasingly global drug supply chain. Both of these provisions eventually will affect BCMA system guidelines, particularly those involving barcode symbologies and data structures.

    BCMA CRS-PharmSupChSec2013.pdf (2013)

    ASHP Policy review Following-Pharmaceutical-Products.pdf (2012)

    FDA Unique Device Identification System Rule (September 24, 2013)

    FDA Unique Device Identification Rule
    This rule established a system to identify devices. With certain exemptions, the rule required that labels on medical devices include unique device identifiers. The rule could play a significant role in transforming the NDC and barcode data structure system.

    Replacing the current NDC system with a next generation scheme as defined by the UDI rule and removing a linear barcode requirement in order to accommodate a federal mandate for supply-chain-wide pharmaceutical serialization and tracking could have a significant impact on BCMA systems.

    These resources provide more information about the regulatory impact and an analysis of the UDI rule.

    Regulatory Impact Analysis of Unique Device Identification System Final Rule

    Unique Device Identifier Study (Consultant Report) (2013)

    Does the Drug Quality and Security Act of 2013 Signify the End of the Linear Barcode?
    This act created a federal pharmaceutical tracking and tracing law pre-empting existing state-level electronic pedigree regulations including those in California and Florida. The development of the system was set to be phased in with new requirements over a 10-year period. Those requirements would include placing unique product identifiers on individual drug packages and providing product and transaction information to ensure integrity at each sale (with lot-level information) in paper or electronic format. The law required the FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings in addition to other efforts necessary to support implementation.

    Drug Supply Chain Security Act (DSCSA)

    How Can GS1 Standards Help Your Company Meet Drug Supply Chain Security Act (DSCSA) Requirements? 

    ASHP Drug Supply Chain Security Act (DSCSA) Resource Center