As recently as five years ago, drug shortages occurred infrequently and generally involved rarely prescribed medications. With ample notice preceding these shortages, developing a detailed and thorough contingency plan was a straightforward process. Today, however, the management of drug shortages has become a foremost challenge in clinical pharmacy practice due to both increased frequency and minimal notification. Further intensifying this practice issue, today’s shortages often occur with commonly prescribed medications, requiring swift efforts to identify safe therapeutic alternatives.
Unfortunately, drug shortage management is not simply an issue of managing supply, but of identifying the impact subsequent product substitutions have on multiple downstream technology systems, including computer order entry systems, inventory and ordering programs, automation and robotics, and smart intravenous (IV) infusion pumps. Safety features of these systems must be aligned with therapeutic alternatives as they are determined. As IV product shortages become more common, and less familiar alternatives are prescribed, it is imperative to focus on the importance of aligning the smart pump drug libraries with these interim changes to enhance IV administration safety.
Identifying and Qualifying Shortages
The Food and Drug Administration (FDA) and American Society of Health-System Pharmacists (ASHP) Web sites are the principle sources for current information on drug shortages. Ongoing updates from these organizations provide the earliest drug shortage notification possible, allowing for a timely—and preferably anticipatory—action plan and response. Open communication with distributors and group purchasing organizations (GPOs) also can assist in the distribution of current drug shortage information to your facility. National drug shortage information is often discussed on professional and clinical organization listservs, so maintaining active participation in these media is beneficial. The key to managing drug shortages as efficiently and effectively as possible is to frequently consult reliable resources for the most up-to-date information.
When a drug shortage reaches your distributor or GPO, the first step is to assess its severity, as this will determine your response. Several key initial questions should be asked:
Guiding Safe Dosing Practices during a Shortage
When safety guards are engaged, hardware and software systems can assist in preserving patient safety during drug shortages. Smart IV infusion pumps are commonly implemented as part of the effort to improve patient safety given their customizable drug libraries, which are designed to generate alarms, alerts, and advisories for the bedside nurse as the pump is programmed to administer an IV infusion to a patient. If the pump is programmed for a dosage setting outside of the preset safety limits in the drug library, the nurse will receive the warning to double-check or even reprogram the pump settings for the medication infusion.
Additionally, supplemental continuous quality improvement software can be purchased that enables ongoing analysis of IV infusion programming practices within a specific facility or health system. Pump programming data are transferred to a central server and include alerts encountered during infusion programming and the bedside nurse’s response to these alerts. For example, the data can track the frequency with which the bedside nurse: 1) bypasses or overrides an alert and continues the infusion as originally programmed, 2) reprograms the infusion within the guidelines, or 3) cancels the infusion. This action-monitoring software, along with the wireless interface of the smart pumps, permits frequent, real-time library updates as specific drug information and product availability changes. This functionality is critical in maintaining a current drug library and in guiding the safe dosing and administration of IV medications, and is especially necessary when managing changes in medications administered due to frequent and unexpected drug recalls and shortages.
Steps for Maintaining the Drug Library
When drug recall information is received from the FDA, quick action at the point of care is required to identify patients currently prescribed the recalled agent. Subsequently, the pharmacist must discuss therapy alternatives with the prescriber and the patient and initiate appropriate therapy conversions. Pharmacists maintaining the smart pump IV drug library should align the library with therapy changes promptly; current content must be modified to reflect the status of the recalled drug and additions and/or revisions of potential therapy alternatives. Recalled medications must be removed from the smart pump drug library and alternatives must be added. A customized advisory also can be added to the alternative drug library entry to remind the nurse of the original drug recall and approved replacement medication. When adding an alternative therapy in response to a drug recall, as with any new medication added to the pump’s library, the appropriate infusion parameters, therapies, and advisories should be created, and the medication name, solution concentrations, common diluents and/or premixed product options, dosing units, weight-based or non-weight—based dosing methods, minimum and maximum doses, and infusion rates should be added to the drug library. Recalled medications should be permanently removed from the drug library once all stock is centralized and destroyed.
During shortages, which can be more unpredictable than recalls, pharmacy must be even more vigilant with smart pump drug library changes. Shortage alternatives are often chosen after discussion with the prescriber or are implemented via hospital-approved automatic substitution protocols. Alternative therapy settings must be added, but because supplies are so variable, the original shortage medication usually should not be removed from the drug library. The smart pump library entry should remain active as the quantities on hand deplete and replete based on purchasing strategies and sourcing from alternative vendors. If a medication has been deleted from the smart pump drug library, but the nurse must administer the medication to a patient, he or she is forced to choose the basic infusion option when programming the infusion, circumventing the safety benefits inherent to the smart pump. For this reason, drugs should only be removed from the library if they have been recalled.
After a smart pump library change is made, a broad nursing communication must be distributed informing the bedside nurses of the manner in which the alternative medication is listed in the smart pump library, and that both the medication on shortage and the alternative agent may be concurrently in supply and active in the smart pump drug library.
Additional Safety Techniques
To preserve safety throughout shortages or recalls, prompt physician order set changes, electronic or paper medical record updates, and pharmacy product labeling must clearly indicate the new or alternative therapy. Smart pumps can also serve to enhance safety by promoting standardization of medication concentration options. Safety techniques, such as Tall Man lettering and capitalization, can be used to highlight differences between look-alike/sound-alike medications listed in the library. Additionally, sites can strategically program the drug library with soft minimum and maximum settings for infusion rates, bolus doses, and/or infusion duration to promote IV drug administration consistent with the most recent published literature and manufacturer information. If exceeded, these soft settings prompt the nurse to double-check the smart pump infusion parameters programmed; the soft settings can be bypassed if clinically appropriate, or the infusion can be reprogrammed within the drug library dosing guidelines. This reprogramming process is the classic medication safety catch that smart pumps have been designed to prompt. Hard-limit settings for infusion parameters can be added as an option to the smart pump library. If the bedside nurse encounters a hard limit during infusion programming, an alert will be generated that cannot be overridden or bypassed. In response, the nurse must cancel the infusion and reprogram within the preset smart pump library parameters.
The smart pump drug library software provides two additional safety features: therapies and advisories. Therapies are created during drug library development and are often used when a single medication has multiple indications that require unique dosing strategies. For example, alteplase is indicated for stroke and acute myocardial infarction; each with different dosing regimens. When the nurse selects this medication from the smart pump drug library, the next screen provides the indication-specific options that subsequently lead to the indication-specific dosing guidelines. Drug-specific customized pop-ups, alerting bedside nurses of safe handling advisories or high-alert drugs, also can be added to the library. For example, medications that are known vesicants can have advisories that serve as warnings and reminders to the nurse that skin irritation or harm can occur upon contact. If specialized tubing is needed for the administration of a medication, such as filtration prior to infusion start, an advisory can be added to the medication library entry reminding the nurse to attach the final filter before starting the infusion.
Collaboration between Nursing and Pharmacy
As shortages occur, a wirelessly driven smart pump library enables the pharmacist to initiate timely library revisions and subsequently monitor the impact of the changes by reviewing new alerts generated during infusion programming, nurse responses to the alerts, and infusion programming patterns. Collaborative review of the smart pump infusion data with nursing fosters communication between nursing and pharmacy, promoting sound, applicable problem resolution and meaningful infusion safety alerts. Understanding nursing workflow at the bedside is important during the build of an effective smart pump drug library and when making library revisions over time. The goal is to avoid building drug-specific infusion parameters that produce alert fatigue or excessive alert dismissal during infusion programming as both can lead to inadvertent overrides of important alerts, potentially leading to errors and causing patient harm. For example, a medication that is commonly administered to a patient over a 60-minute timeframe can have a drug library entry built to allow administration within a range of 30 minutes to 90 minutes, as supported by the literature. As this expanded duration window still protects the patient by ensuring the IV medication is administered safely, it also provides the bedside nurse needed flexibility. For example, if an infusion is started and the patient is required to leave the unit for a procedure, the nurse can shorten the duration to ensure the full dose is administered prior to the transport.
During times of recalls and drug shortages, pharmacy’s involvement is fundamental to ensuring patient safety. In addition to employing multiple communication methods and updating order sets and protocols, the smart pump, with its provision of accurate, visual, and embedded drug specific information to the bedside nurse, is another key tool for ensuring safe transitions to new therapies.
Cynthia Niccolai, PharmD, is a clinical pharmacist in the Drug Use and Disease State Management Program at the University of Pittsburgh Medical Center. Cynthia received her Bachelor of Science in Pharmacy from Duquesne University and completed an ASHP-accredited pharmacy practice residency at Allegheny General Hospital in Pittsburgh, PA. She completed her Doctor of Pharmacy degree at the University of Arkansas School of Medical Sciences.
Susan Skledar, RPh, MPH, FASHP, is a clinical pharmacist at the University of Pittsburgh Medical Center (UPMC) Presbyterian, and is the director of the Drug Use and Disease State Management Program. She is a fellow of the American Society of Health-System Pharmacists. Susan is an associate professor in the Department of Pharmacy & Therapeutics, at the University of Pittsburgh School of Pharmacy, precepting students and lecturing in the Doctor of Pharmacy Curriculum and has been a faculty member since 1992. She received her Bachelor’s degree and Master of Public Health degree from the University of Pittsburgh.