Developing safe processes that prevent medication errors is an ever-present concern in hospital pharmacy. This is particularly so given the prevalence of high-alert medications, the processes used in conjunction with them, and the difficulty of detecting IV product errors once those products leave the control of the pharmacy. When it comes to sterile IV products, focusing on best practices in labeling, taking advantage of bar code technologies, and implementing dose-tracking tools can significantly bolster the safety of IV services.
The Duke University Hospital (Duke) in Durham, North Carolina, is a 924-bed academic medical center serving a wide range of patient populations. Within the pharmacy, the Sterile Preparations Cleanroom (SPC) is tasked with compounding custom, highly complex therapies, and dispenses over 2100 IV fluids and syringes daily. The pharmacy department at Duke, in collaboration with non-pharmacy colleagues, has developed a number of error-prevention strategies related to IV product safety, especially those involving bar code technology.
Bar code verification is used in multiple ways at Duke to bolster safe preparation and administration of compounded sterile preparations (CSPs). Prior to a recent electronic health record (EHR) implementation, these activities were primarily controlled by the SPC’s use of a homegrown software system (called ScanIV, featured in the July 2010 issue of PP&P). ScanIV began as a database that compared the item ID pulled from the pharmacy information system (PIS) to the product’s bar code, ensuring proper product selection. Over a number of years, the system was continually improved, but the most significant leap was the creation of an interface directly with the PIS to pull in order-specific information, allowing bar code verification of product selection for virtually all CSPs.
The recent EHR implementation process revealed that differing database structures precluded future use of ScanIV. Instead, we focused our effort on duplicating the safeguards that ScanIV incorporated into the cleanroom workflow into the new EHR. Pharmacy now takes advantage of safe workflow processes for dose preparation that are built into Duke’s EHR system. Modules in use include a workflow queue, technician bar code scanning of product selection, and final pharmacist review of CSPs. These functions of the new EHR achieve similar safety in sterile compounding product selection as was afforded via ScanIV. Given the large numbers of look-alike/sound-alike drugs in CSP processing, bar code verification of drug selection is a key aspect of pharmacy’s approach to medication safety.
Labeling and Bar Code Challenges with Outsourced Products
Outsourcing for IV products is a common supplement when internal production capacity and operational need is maximized. The practice also enables facilities to take advantage of extended stability for certain products afforded by vendors with the additional resources necessary for the types of stability and sterility testing required by USP <797>. Our guides in choosing to outsource include previous experience with particular compounding suppliers, their demonstrated ability to use validated compounding practices and present quality assurance data, and a proven track record of customer service. In addition, ASHP’s guidance on outsourcing sterile compounding has been a valuable resource when engaging new vendors.
However, the benefits of outsourcing are sometimes tempered by the logistical challenges the practice can introduce to a seamless workflow. For example, there are often labeling differences for in-house compounded products versus outsourced products. Variation among outsourcers with regard to labeling and bar code symbologies must often be addressed by pharmacy to avoid confusion for our nursing colleagues. It is important for pharmacy to recognize any issues that nursing staff may experience with IV product label scanning and interaction with nursing staff is vital in identifying and preventing bar coding problems. At Duke, this is achieved not only through traditional avenues of communication, but also through use of an institutional safety reporting system and pharmacy’s monitoring of compliance with bedside bar coding protocols.
Proper pharmacy workflow often requires relabeling doses that originate both in-house and from vendors, and relabeling is routine when dispensing patient-specific doses (ie, not through an ADC) or when the expiration date of the product may require adjustment (eg, short-term, room temperature storage in an ADC or anesthesia work station when the labeled expiration assumes refrigeration). Furthermore, high-risk or hazardous medication labels often require additional information for the end-user. The preferred approach is to program these into the EHR or other software that generates a label for those products. For example, a default comment may be built for a particular drug code for printing directly on patient-specific dose labels, mitigating errors of omission (eg, forgetting to apply an auxiliary label).
Challenges of Syringe-based Doses
The comprehensiveness of syringe labeling is limited by the small space available for the label. However, there are several labeling elements that are integral to proper use and patient safety. Specific inclusion of drug name, dose, volume, concentration, stability, proper storage conditions, and any applicable warnings (ie, use of filters, protection from light, etc), are all vital elements of syringe labels. Certainly, information that enables nurses to accurately manage the six rights of medication administration is critical for inclusion on the human-readable portion of a label. For bar coded information, 2D bar code symbologies, such as Aztec or DataMatrix, enable efficient use of space compared with linear bar codes. Keep in mind, employing 2D bar codes requires that the system and scanners that read bar codes within the facility are compatible with this symbology type. For instance, some TPN compounding pumps only read linear bar codes, so be sure to confirm system compatibility before implementing a new bar code type.
Standardizing syringe labeling can reap many benefits, but enabling this begins with proper staff training. Pharmacy staff members are trained in standardized labeling upon initial employment orientation and annually thereafter. This training is included as part of our standard policies and procedures (P&Ps) for sterile IV product compounding, a part of which is proper labeling of all IV bag and syringe doses.
At Duke, part of the standardization process for our syringes labels included working with a human factors group. The key benefit of this work was designing a label that put the right information in the right place for the end user. One specific challenge to syringe labeling is that flag labels are commonly required, but all product information often cannot be seen simultaneously due to the need to flip the label over. Given the error-prone nature of this action, we made label design choices to ensure label text was arranged to minimize flipping. For example, the entire drug name and dose amount is visible on one side of the label. Similarly, the patient identifiers of name and medical record number were also placed together on the same side of the label. Text that is less critical or that is less frequently associated with errors—such as encounter number, room location, and expiration—is printed on the opposite side of the label.
For patient-specific doses, ensuring the integrity of syringe bar codes is achieved largely through the pharmacy’s own process of scanning. There are two fundamental steps in the SPC—technician preparation and pharmacist verification—that require the bar code on the EHR label to be scanned prior to dispensing. If it scans properly in the pharmacy, there is a high degree of confidence it will do so at the point of care.
For syringes 0.8 mL and smaller, 0.05 mL overfill is included. Volume can be lost due to the subsequent compounding steps of adding a syringe cap, which tends to introduce a small amount of air, and removal of the cap by the nurse administering the dose. The EHR is programmed to print an overfill warning statement that is included on the labels of doses that meet this condition.
IV vs PO
Errors related to syringe-based medications are not limited to compounding or labeling. Because of the relatively widespread use of both oral and IV syringes for medication administration, there is concern about oral syringes being mistaken for IV syringes (or vice versa) and administered as such. In order to prevent this type of error, different syringe types are used for oral syringes and compounding practices are segregated for PO doses (ie, oral doses are never dispensed from the SPC). However, on occasion, the injectable form of a drug is needed to prepare an oral dose and this can be challenging if it involves a hazardous drug. To address this need, the central pharmacy (non-sterile compounding area) is equipped with a barrier isolator designated for handling all hazardous oral doses.
The pharmacy is currently investigating a dose delivery tracking system through which the location of specific doses would be tracked by bar code scanning at all pick-up and delivery steps. As it becomes cost-efficient, RFID technology may play a major role in reducing missing doses and other similar rework by providing extensive data on dose location, status, and expiration.This system, in conjunction with time data of dose preparation, verification, and administration afforded by the recently implement EHR, will provide a powerful data set for future process monitoring and improvement.
Given the complex manner in which medications are managed throughout the patient care continuum, maintaining strict control over the information that is placed on IV bags and syringes is as important as the integrity of the medications placed inside them. As technology continues to chase a truly closed system for medication preparation, tracking, and administration, it is pharmacy’s obligation to keep abreast of available technologies and practices.
Stephen Arrowood, PharmD, MHA, is manager of the Sterile Preparations Cleanroom at Duke University Hospital. He earned his PharmD and Masters of Health Administration from the University of North Carolina.