Drug shortages are a continuing problem in the United States. Shortages can impact all aspects of the healthcare delivery system from patient safety and quality to financial operations and 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.
"The drug shortage epidemic peaked in 2011, causing the U.S. Food and Drug Administration (FDA) to require that all drug manufacturers report anticipated and current shortfalls. In 2012, the FDA created the Safety and Innovation Act, requiring manufacturers to provide advance notification of expected disruption. However, drug shortages can be the result of myriad causes — natural disasters, production problems or shipping delays can affect availability nationwide, and unexpectedly high use or incorrect order volume may exhaust a hospital's supply of an important drug unexpectedly. Sometimes there's little advance notice of a shortage and the team needs to act fast to follow hospital policy and prevent patient harm.
Drugs continue to be the number one tool for managing and treating disease in the U.S. and that trend shows no signs of changing. Although there are fewer shortages now, more are occurring among drugs that are used commonly in the hospital setting. Hospitals nationally have recently reported drug shortages among critical care pain medications like fentanyl and morphine, as well as antibiotics, and products that are ubiquitous in every area of acute care facilities like IV fluids including 0.9% sodium chloride injections, and sodium bicarbonate1.
Leveraging your pharmacy teams' expertise
Given the pharmacy team's intimate knowledge of their hospital or system, having them conduct clinical surveillance throughout a hospital means they use their unique expertise to assess each patient's medications and determine whether they are appropriate. Their goal is to ensure each patient receives the most effective drug for their medical condition, safe in the context of comorbidities and other medications and the most cost-effective option. Top-performing hospitals are proactively adopting strategies to address drug shortages and maintain the highest quality of care.
Best practices include:
- creating a drug shortage committee that maintains a list of the most commonly used drugs
- thorough monitoring of life-sustaining therapies deemed most critical to patient care for potential shortage situations
- regular meetings to discuss strategies for addressing current and upcoming shortages
- the creation and adoption of ethical and procedural guidelines to address prioritization or rationing protocols for distribution of agents on shortage2-4
Leveraging technology for real-time monitoring and alerts
Pharmacists have the knowledge and expertise—but they also need the tools to support key drug management initiatives. Electronic Health Records (EHR) are frequently tapped for insights in a patient's individual care but fall short when looking across a patient population to identify trends such as prescribing patterns of drugs at-risk for shortage. Clinical surveillance solutions can seamlessly integrate with EHRs to provide deeper insights and more robust tools for pharmacists managing a medication management initiative for their hospital.
Here's one example of how it 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.
- There is no need to submit a project request or wait for someone in IT to create the rules — in minutes clinicians can write and publish their own sophisticated patient identification rules.
- The care team can be confident that patients will be identified in real-time and the pharmacist can work with the prescribing clinician 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 who are trending toward requiring an agent that is on shortage. This type of proactive capability offers clinicians more time to either research the literature for an alternative therapeutic agent or to make arrangements for acquiring the medication from another facility or site.
- Once a drug is no longer on shortage, it is easy for the pharmacist to discontinue the rules so they avoid 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 see 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 and clinical surveillance technology to systematically monitor all of the patients in the hospital in real time, empowers clinicians to address shortages as soon as the situation occurs. What's more, 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.
1. FDA Drug Shortages website. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed July 19, 2018.
2. Drug Shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-20
3. Traynor K. Drug shortages a daily concern for emergency departments. Am J Health Syst Pharm. 2018 July 15;75(14):1007-8
4. Fink S. Drug shortages forcing hard decisions on rationing treatments. The New York Times. https://www.nytimes.com/2016/01/29/us/drug-shortages-forcing-hard-decisions-on-rationing-treatments.html. Accessed on July 23, 2018.