Drug shortages continue to be a significant hurdle to safe and efficient healthcare delivery in the United States, with no effective, long-term solution in sight. Limited access to essential medications can delay life-saving treatments, increase the risk of patient harm, and lead to financial implications related to cost management.
The American Society of Health-System Pharmacists (ASHP) defines a drug shortage as "a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”
In response to the threat of drug shortages, the U.S. Food and Drug Administration (FDA) signed the 2012 Safety and Innovation Act, requiring manufacturers to provide alerts on expected disruptions in their drug supply chain. However, drug shortages can result from myriad causes — natural disasters, production issues, or shipping delays can impact nationwide availability. An unforeseen, rapid surge in the use of a medication or an incorrectly placed drug order could potentially exhaust a hospital's supply of an important drug. Often, there is little notice of a drug shortage until the downstream effects are already in play. The hospital team must act quickly to implement clinical and operational mitigation strategies.
Drugs continue to be an essential tool for managing and treating disease in the U.S. Although drug shortages can seem abrupt and unpredictable, a common trend is that more shortages occur among drugs commonly used in the hospital setting. A recent national ASHP survey of pharmacists finds that nearly all pharmacists (99.7%) see the impact of drug shortages on healthcare delivery, with 7% of respondents reporting at least one shortage-related safety event that resulted in patient harm. Hospitals nationally have recently reported drug shortages among sterile injectable drugs, with the most reported short supply consisting of heparin, pain medications such as hydromorphone and bupivacaine/ketorolac/ketamine, and many antibiotics. Products that are ubiquitous in every area of acute care facilities, such as sodium chloride and dextrose fluids and their injectable syringe formulations, have experienced continuous shortages in the past few years and remain a difficult challenge to circumvent.
Leveraging pharmacy teams’ expertise to tackle drug shortages
Given the pharmacy team's intimate knowledge of the hospital or health system, combining their clinical expertise with clinical surveillance allows them to assess each patient's medications and determine whether they are appropriate. They aim to ensure that each patient receives the safest and most effective drug for their medical condition. Top-performing hospitals proactively adopt strategies to address drug shortages and maintain the highest quality of care and patient safety.
Best practices include:
- creating a drug shortage committee that maintains a list of the hospital’s most commonly used drugs and monitors a crosswalk with the FDA Drug Shortages website and ASHP’s Drug Shortages List
- thorough monitoring of life-sustaining therapies deemed most critical to patient care for potential shortage situations
- meeting regularly to discuss strategies for forecasting and addressing current and upcoming shortages
- creating and adopting ethical and procedural guidelines to address prioritization in criteria for use or policies on rationing the distribution of agents on shortage. See more best practices gathered from studies on the impact on patient care, emergency departments, and rationing treatments
The role of real-time monitoring and alerts in improving transparency through drug shortages
Pharmacists may have the necessary knowledge and expertise to approach operational and clinical issues in medication management, but they also need the tools to support key drug management initiatives. Electronic Health Records (EHR) are frequently tapped for insights on a patient-by-patient basis, but their utility falls short when looking for the “big-picture” trends across a patient population to identify prescribing patterns of drugs at risk for shortage. Clinical surveillance solutions can seamlessly integrate with EHRs to provide meaningful insight and more robust tools for pharmacists who own a medication management initiative for their hospital.
Here's one example of how surveillance during a drug shortage might work:
- As soon as a potential shortage is identified, the pharmacy can use surveillance technology to write rules to identify patients in real-time who are receiving the drug in short supply.
- There is no need to submit a project request or wait for someone in IT to create the rules —clinicians can immediately write and publish their own sophisticated patient identification rules to capture current utilization of the specific drug.
- The care team can be confident that patients will be identified in real-time and that the pharmacist can work with prescribers to address each patient situation according to the hospital's policy around drugs at risk of being in short supply.
- Clinical surveillance rules can also prospectively identify patients trending toward requiring an agent that is in shortage. This type of proactive capability offers clinicians more time to research the literature for an alternative therapeutic agent or to make the necessary arrangements to acquire the medication from another facility or site.
- Once a drug is no longer in shortage, the pharmacist can discontinue the related surveillance rule as it is no longer relevant, and doing so will thus decrease alert fatigue. Again, no need to wait for IT — the pharmacist can effortlessly turn off the rules themselves.
- Real-time reporting and robust data-filtering capabilities are utilized to picture trends in drug usage and prescribing patterns across a system. These insights can be effectively used to drive standardization of the drug management initiative and engage and train clinicians to reduce variations in care.
Drug shortages are here to stay. Leveraging the expertise of the pharmacy team with clinical surveillance technology to systematically monitor all patients in the hospital in real-time empowers clinicians to address shortages as soon as the situation arises. Moreover, once a medication management plan is standardized and fully implemented system-wide, clinicians can consistently provide the safest and most appropriate medication for each and every patient and manage future shortages without compromising care.
