Managing NDC and Product Changes

May 2012 - Vol.9 No. 5 - Page #6

In hospital pharmacy practice, change is constant: practice models come and go, technology is introduced and replaced, personnel are added and subtracted, and processes are created and adjusted. New products are introduced and old products fade from use at an increasingly dizzying pace, and even when the products do not change, the NDC numbers identifying them often do. Managing these changes properly to avoid impacting patient care has been an ongoing struggle at our institution, and we are constantly working to refine our methods to ensure seamless workflow and patient safety.

Tufts Medical Center in Boston is a 451-bed facility that serves as the primary teaching hospital for the Tufts University Medical School, and has adult, pediatric, and neonatal ICUs. The pharmacy utilizes a centralized distribution model, with the exception of some pediatric medications and both adult and pediatric outpatient hematology/oncology products, which are prepared decentrally. ADCs are located on the nursing units and restocked multiple times daily from the central pharmacy, using bar code scanning to ensure the correct product is stocked in the correct compartment. CPOE has been fully implemented for the adult population, and the pharmacy computer system is integrated with an eMAR/BCMA system that has been deployed in all inpatient areas. Smart pumps are in use throughout the hospital, and in late 2012 we plan to implement a medication carousel system that will interface with the ADCs. While these electronic systems work synergistically and provide an unparalleled level of patient safety when used with their safety mechanisms fully employed, the safety benefits are contingent on the timely and accurate updating of NDC and product changes. 

NDC Changes
Although pharmaceutical purchases are largely determined by our purchasing contract, contract changes, stockouts, shortages, and changes in policy or operations processes may dictate that alternate products—or equivalent products from different manufacturers—are purchased. Stockouts and shortages are managed by the pharmacy purchasing department staff, who decide at the time the order is placed which product will best meet our needs at the lowest cost. Some product change decisions, such as outsourcing the manufacture of certain IV solutions, are made by the operations manager with the approval of pharmacy leadership. Our purchaser is constantly tracking shortages and potential shortages and seeking high-quality alternative product sources. 

Impact on Downstream Systems
Pharmacy System/CPOE
Many of our downstream systems are dependent on or affected by the information in our pharmacy computer system’s drug database. Nearly every product change—NDC number, cost, package size, and concentration—is recorded in the pharmacy drug master file. The pharmacy purchaser keeps track of all product changes on a spreadsheet, which is sent to the pharmacy informatics department on a weekly or biweekly basis to be processed by the pharmacy informatics team. Changes that will take effect immediately (within a day or so) are communicated to the informatics team on an ad hoc basis outside of the usual process. The relevant product changes are communicated via interface to the CPOE drug file, although this process does not always work as intended and manual edits must then be made in the CPOE drug file. Occasionally, a change also dictates that edits be made in predefined orders and/or order sets in both the pharmacy and CPOE systems. 

Most product changes are managed by editing the existing entries in the pharmacy drug file. At times, however, it is more appropriate to create a completely new entry and inactivate the old entry. It is never appropriate to completely delete an entry from the system, as this will adversely impact historical data related to that entry.

The eMAR/BCMA system is impacted primarily by changes in the package bar code rather than by other types of changes. Every weekday after our order arrives, each item is scanned to determine whether or not the bar code is recognized by the eMAR/BCMA system. Those products with bar codes that do not match an entry in the system are set aside to be cross-referenced to the proper entry in the pharmacy/eMAR drug database by one of the informatics pharmacists. 

Despite this process, items occasionally fall through the cracks. If a product arrives in the nursing unit without being cross-referenced, nursing has been instructed to contact the pharmacy to verify the product is correct and to ensure the cross-reference table is updated in a timely manner. A limited number of pharmacists have been trained to update the cross-reference table during off hours, although a second pharmacist check, or technician check if no second pharmacist is available, is required to ensure accuracy.  

Product bar codes identified as not being cross-referenced in the eMAR/BCMA database are assumed also to be absent from the ADC product cross-reference. Consequently, once the informatics pharmacist has updated the eMAR/BCMA database, the ADC database is subsequently updated. 

This process is imperfect, however, as sometimes the eMAR/BCMA product recognizes an equivalent medication based on background information supplied by the drug database vendor. This is not the case with our ADC database, so often these items are identified during the refill process and must be returned to the pharmacy to be cross-referenced before the refill process can be completed. Pharmacists have been trained to update the ADC cross-reference table, with a double check by a pharmacist or a technician if no second pharmacist is available. These changes are recorded in a paper log and reviewed by the informatics team. Our ADC product does not provide an audit trail for these updates, but we have requested that our vendor provide this functionality. 

Smart Pumps and Carousel
Because our smart pumps are not driven by either NDC or bar code information, the only changes that impact that system are those involving IV drip concentrations. Whether this is an operationally driven change or one dictated by product shortages, the information is communicated to the manager of the smart pump library, who makes the required updates. The updated library is wirelessly transmitted to the pumps themselves. After the carousel is implemented, we anticipate the process for addressing product changes will include a combination of the processes used for updating the pharmacy and ADC systems. 

Proper management of NDC and product changes is required to ensure the accurate capture of product costs and billing. Cost and charge information is housed in the pharmacy drug file, which is updated regularly using the product change process and by regularly downloading a file from the wholesaler that automatically updates the cost information in the system. However, there are other changes that impact billing. Some third party payers—particularly state Medicaid plans—require that in certain circumstances the product NDC number be submitted with the claim. This creates a challenge, as at times there may be multiple versions of the same product available for administration, each with a different NDC number. Because only one NDC number can be assigned to a product at one time, the charge or NDC number must be generated based on the product scan performed at the time of administration. Software customization provided by the vendor may improve this process. While we have the ability to generate a charge on scan, we plan to request that the vendor configure the system to link the NDC of the actual product scanned to the charge.

Process Pitfalls
Despite our best efforts, several situations occur where changes may be missed. 

  • The receiving technician may assume that because a product manufacturer has not changed, the product bar code is still the same, and skip scanning that item on receipt. Although an item may have the same manufacturer as the item it replaces, the bar code will not necessarily be identical.
  • The receiving technician may scan the bar code on the outer package rather than the bar code on the product itself. 
  • Some manufacturer product bar codes scan inconsistently or with difficulty. 
  • Because controlled substances are received using a different process, those product bar code changes are missed more frequently. 
  • Changes in product strengths or concentrations must be handled carefully to ensure that two different concentrations of the same product are not simultaneously available for administration, a practice that greatly increases the potential for error. 
  • Occasionally, the person placing the order may not communicate a change (such as having to purchase a substitute product due to a wholesaler shortage) to the buyer, and thus downstream communication of the change does not occur. 

When these types of issues are identified, we address these challenges through one-on-one education of the staff involved.

Future Goals
Our processes for managing NDC and product changes are not flawless; we consider them works in progress. Undoubtedly, any time human intervention is involved in updating systems, there is a chance that a process will be carried out imperfectly. Our current system requires that all database changes have an electronic audit trail and a process that ensures at least two individuals, preferably two pharmacists, have verified the accuracy of the change. In the future, we hope to further standardize the process to better ensure accurate charge capture and improve workflow.

Franklin P. Crownover, RPh, MSHI, has served as the pharmacy informatics coordinator at Tufts Medical Center in Boston since 1999, following 22 years as a clinical pharmacist in various hospital and retail settings. He received a BS in Pharmacy from the University of Mississippi in 1977 and an MS in Health Informatics from Northeastern University in 2009. Franklin is active in the American Society of Health-System Pharmacists Section of Pharmacy Informatics and Technology and is the current vice-chair of the Section Advisory Group on Clinical Information Systems. 

Formulary Change Within an Integrated System

By Raymond C. Chan, PharmD

Because a single missed detail can have a significant impact on patient care, system integration—that is, standardization among various vendor systems such as CPOE, BCMA, and the pharmacy information system (PIS)—facilitates a beneficial domino effect within medication management. From order entry by physicians, to verification of orders by pharmacists, to scanning and checking of medications by nurses, information flows more efficiently and accurately in an integrated system based on common definitions, which benefits patient health and safety. In addition to establishing process uniformity, standardization also allows for more seamless updates when formulary changes or updates are required.

Smooth Execution
Given the ever-changing nature of pharmacy practice, with the continual release of new formulations and indications, bar code changes, formulary updates, and medication shortages, pharmacists traditionally served as the enforcer of P&T decisions. However, by adopting integrated systems, a large portion of formulary management can be shifted to the system itself. Of course, such a transition is far from simple; considerable input is required from various stakeholders to achieve smooth execution of both initial system integration and subsequent updates to the formulary throughout the system. Information technology (IT), clinical, operations, and management staffs must cooperate when systems integration is undertaken. A formulary implementation group (FIG) should be created to provide a forum to review any problems or issues that arise as a result of integration. Staff representatives from each group should attend each FIG meeting, which can be scheduled at the same frequency as P&T committee meetings. Requests for additions or changes to the formulary can then be funneled through the FIG and prioritized based on need and safety concerns. 

Case study: Introducing Fondaparinux
To illustrate best practices for making a formulary change within an integrated medication management system, consider the steps our facility recently took to add fondaparinux as a formulary medication, replacing enoxaparin as the anticoagulant of choice for various indications. The P&T committee, pharmacy management, and various clinical specialty subcommittees were required to weigh in on the decision to make this change. Subsequent to their approval, all standing policies and protocols were modified to reflect the change, uploaded, and attached to the appropriate hyperlinks within the integrated system where all staff members have access to these documents. 

Simultaneously, the initial notification of the P&T committee decision and subsequent impending change notification documents were disseminated via standard communication lines to ensure that staff members were alerted to this change. 

The FIG determined that an education campaign also was needed—a critical step in switching one commonly used anticoagulant for another. The scope of education will vary depending on the complexity of the change, but with the introduction of fondaparinux, our education process was projected over several months and included tools such as computer-based training, continuing education presentations, multiple staff meetings, and concise summaries of the forthcoming changes. In addition, we utilized formal documentation and clinical evaluations completed by our P&T committee and clinical specialists.

While the education process was unfolding, the IT department simultaneously began assessing the system build required to make the proposed changes. When a new drug or drug formulation proposal is presented to the FIG, it is compared to the drug master file that is periodically updated via national drug database vendors. Given a vendor-supplied, standardized entry in the master file, IT must build in additional information such as customized display names (eg, CPOE and labels), common search terms (eg, drug class), and indication-specific regimens (eg, deep vein thrombosis prophylaxis and pulmonary embolism treatment in order sets/protocols). 

At this juncture, the FIG must consult with the Clinical Decision Support (CDS) committee, which oversees all forms of CDS in the integrated system, to determine which portions of this information will add value to the integrated system. For fondaparinux, vendor-supplied alert settings for drug-drug, drug-allergy, duplicate therapy, and pregnancy and lactation were reviewed and customized according to clinical relevance. It was determined that supplementary alerts also would be built to monitor creatinine clearance, platelets, INR, and hemoglobin changes to improve safety with the new anticoagulant. 

The FIG and the CDS committee will need to consider any peripheral devices that need configuration in conjunction with the integrated system, which could include ADCs, smart pumps, and bar code scanners with corresponding product information and labels/bar codes in their various forms. This process will allow the entire workflow and various possible permutations to be tested and evaluated by IT specialists.

Because the effects of certain operational decisions—such as NDC choice, quantities, preparation processes, methods of delivery to the floor, label appearance, and determining adequate stock for ADCs—will cascade throughout the integrated system, it is essential that they are made and implemented correctly. The successful implementation of operational decisions will hinge on open and synchronous communication among the four legs of the FIG: the clinical, IT, operational, and management groups. 

Promoting Patient Safety
Clearly, making formulary changes within a standardized medication management system can be challenging, especially in larger institutions or within expanding systems. However, having comprehensive procedures in place to make such changes within an integrated system saves staff time and effort in daily tasks such as ordering, checking, and administering medications; more importantly, using approved pathways promotes patient safety by allowing staff to place orders and communicate consistently and uniformly —which ultimately improves patient care.

Raymond C. Chan, PharmD, is the informatics specialty residency coordinator at Sentara Healthcare in Norfolk, VA and serves on the FIG and the CDS committee. He graduated from the University at Buffalo.


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