The concept of regional and national drug shortages is not a recent phenomenon, as instances stretch back decades, but beginning in approximately 2007, the number and impact of drug shortages escalated and became the norm for institutional pharmacy practice. Due to the increased numbers of drugs affected, as well as the duration of shortages in recent years, the problem has become far more difficult to manage, as there also are fewer, or in some cases, no alternate sources for replacement products from another manufacturer. While the number of drug shortages appears to have peaked in 2012 with a resulting decline (see Drug Shortages Data on p. 82), shortages management remains a challenge for many hospital facilities.
This reality is not lost on pharmacy regulatory agencies, so to highlight the importance of hospitals implementing and rigorously maintaining effective drug shortage management strategies, The Joint Commission added additional standards (see SIDEBAR) to appropriately address drug shortages and emphasize the use of vetted substitution protocols when necessary. During a recent Joint Commission visit at The University of Illinois Hospital & Health Sciences System (UI Health) in Chicago, drug shortage management was a specific topic of discussion during our medication management system tracer session.
Define the Scope of Shortage Management
The predominate problem of drug shortages is their significant potential to negatively impact numerous individuals, including most health care practitioners and, ultimately, the patients. Therefore, one of the overriding goals of a drug shortages management plan should be to effectively limit, to the degree possible, the impact of shortages downstream from the pharmacy. This requires the pharmacy to be prepared for both expected and unexpected shortages, and to manage and delegate drug supplies for their full duration.
Effective drug shortage management requires gathering and distributing a significant amount of information. Among the most vital details that should be gathered and communicated to affected staff include what caused the shortage (eg, drug quality issue, manufacturing breakdown, product elimination, supply not meeting demand, etc) and its expected duration. Additionally, significant onus is placed on the purchasing agent’s ability to obtain equivalent products from alternate, legitimate sources as early as possible into the shortage (keep in mind, if a shortage is national, there will be competition to acquire alternate products).
Once a shortage is known, it is important to quickly evaluate the facility’s usage data for the affected product to estimate the impact. Determining current inventory will help in devising an estimate of how many days worth of stock is available, assuming no restrictions are implemented. This, in turn, will help to determine whether the facility can weather the estimated time of the shortage, as well as establish the amount of time the facility has to develop and enact a plan for providing medication therapy in the event the shortage is extended beyond the exhaustion of current stock levels.
Ensure Proper Accounting of On-hand Stock
In most hospitals, medication storage can be spread widely throughout the main facility and attendant clinics. Automated medication storage systems, such as automated dispensing cabinets (ADCs) and computerized inventory management systems often can be quickly surveilled. However, manual-based medication storage locations, such as drug trays and carts, emergency supplies (eg, drug boxes, transport boxes, crash carts), and miscellaneous storage in pharmacy operational areas may not be electronically managed, and thus require manual inspection. Frequent communication with the purchasing agent regarding the ability to obtain drug supply is necessary to gain as much lead time as possible in assessing the organization’s supply and usage (therapeutically and quantitatively), and to integrate this information into the overall management plan.
Management Plan Initiation
Under the direction of the pharmacy & therapeutics (P&T) committee, pharmacy must focus on prioritizing the facility’s use of a short supply drug, develop medication use guidelines as needed, and enforce any ordering or usage restrictions. Medication use guidelines should be developed in cooperation with physicians and other affected clinicians; a process that helps reinforce to all practitioners the importance of management strategies that reserve critical drug supply for patients with the greatest need. Clear criteria for utilizing a new product and continuing the use of the short supply drug require a comprehensive review by all stakeholders in order to ensure appropriate use.
Generally, today’s pharmacy and hospital-wide IT systems can be updated quickly to help prevent medication safety issues. However, sound advanced planning can conserve the valuable time necessary to update and harmonize multiple ordering and information systems. Thus, pre-identifying systems that will need modification according to the shortage reaction plan is essential. Ideally, all information systems (ie, ordering, verifying, dispensing, and administering) can be updated with amended information, and be ready to go when the shortage plan is implemented. The process of pulling one drug (short supply) and inserting an alternate product is challenging under non-pressure situations, but it will be even more difficult to do seamlessly in an unforeseen shortage if the pharmacy and IT system updates are not well thought out and tested in advance.
Affected Products and Information Systems
Concern over the potential for medication safety issues related to drug shortages and drug substitutions is the primary reason The Joint Commission implemented changes to its medication management standards. Accordingly, if these standards are not properly adopted, patient safety could indeed be compromised. Examples of changes to safety-dependent activities and information as the result of a drug shortage and/or drug alternate substitution include:
In addition, database updates likely will affect the following systems:
Keep in mind, not all shortages will affect an institution at a facility-wide level, as pharmacy-only strategies are sometimes an option during a drug shortage. For example, some drug products (such as electrolytes) that are utilized for compounding can be conserved through careful analysis of compounding data to identify exactly how much of that product is being utilized and determine whether there is excessive waste of that product. This will help direct process adjustments to minimize waste and maximize product utility; a worthy analysis in any case.
The abovementioned example is important, though, as electrolyte (and similar) shortages can wreak havoc on clinical operations if changes are not properly implemented. Recently, we switched from a US-based injectable product for sodium phosphate to an imported product (allowed by the FDA) due to a critical shortage. However, the imported product was organic based, versus the inorganic product manufactured in the US. In order to accommodate this change, we had to make the following adjustments to our systems and practices:
Other pharmacy-only strategies include reviewing ADC data for unit-specific utilization. Often, certain areas of the hospital rarely use a particular medication, allowing for redistribution to the areas that need it most in the event of a shortage. Sometimes these low-impact strategies can buy enough time to see the operation through until alternates or additional supply is made available.
Although a shortage may be deemed low impact, pharmacy-only strategies are not without their challenges. For some, maintaining precise control of inventory on hand can be cumbersome, as medications often are located within multiple systems. The date the product is expected to exit shortage and return to the normal supply chain can be used as a guide to determine whether the current supply will meet demand without having to implement restrictions. Keep in mind, the expected shortage end date may be erroneous, so ongoing inventory tracking is critical in order to prevent a stock out situation. Even with best intentions and effective stock conservation methods in place, several medications in the past few years have remained on shortage well beyond expectation and supplies have been exhausted.
If practice changes are necessary to manage a high-level shortage, additional actions beyond forming dosing protocols and medication use guidelines will likely include changes to the dispensing (for pharmacy) and administration (for nursing) models. For example, a hydromorphone shortage resulted in several practice changes affecting pharmacy and nursing at our facility. Our preferred dose sizes for the injectable product were 1 mg and 4 mg syringes. During the shortage, which affected the availability of 1 mg syringes, we obtained alternate 1 mg hydromorphone syringes that were a larger size than our usual product. To accommodate this, we implemented the following strategies:
This example illustrates how new medication use guidelines sometimes require practitioners to adjust the treatments or therapies by utilizing a different medication concentration in the same class, or a different class of medication all together. Furthermore, sometimes there is no effective substitute and a patient’s medical procedure may have to be delayed or a diagnosis could be compromised. Thus, education is important in these types of situations when trying to engage the medical staff, and ongoing pharmacy involvement is necessary to enforce any revised medication use guidelines.
Communication is the Cornerstone
Simply put, effective drug shortage management strategies require effective communication, especially when they involve practice changes that affect physicians. Incorporating medication use guidelines directly into electronic ordering is perhaps the most effective way to communicate this information to physicians. In settings where paper orders are still utilized, ensuring proper information exchange is even more challenging. In this case, drug shortage communication boards can be prominently placed in clinical areas to convey important information and posting shortage information on the facility intranet or through targeted emails can be effective as well
Establishing a strong drug shortage management process is integral to an overall medication error prevention strategy. In order to be effective, the process must comprise sound data, the right staff to identify potential problems and solutions, and effective communication of the shortage plan. Keep in mind that an often overlooked aspect of a comprehensive drug shortage plan is reversing the plan once the preferred product comes back in stock in sufficient quantities. Therefore, a reversal plan is just as important and requires a well thought out process to prevent miscommunication, medication delays, and medication errors.
Connie Larson, PharmD, is associate director of safety and quality for Hospital Pharmacy Services at the University of Illinois Hospital & Health Sciences System (UI Health), as well as a clinical assistant professor at the UIC College of Pharmacy. She also is UI Health’s medication safety officer and the Joint Commission liaison for medication management standards. In her academic appointment, Connie assists in the training of fourth-year pharmacy students and post-graduate pharmacy residents with a focus on medication safety. She earned her PharmD from the University of Illinois at Chicago, College of Pharmacy.
Revision to MM.02.01.01
These revisions, instituted in 2011, indicate that a drug shortages management plan must be a formal process (ie, not ad hoc for individual drugs). Likewise, the presence of a drug shortage does not absolve the facility from performing due diligence and risk assessments of any proposed and enacted interim measures.
Elements of Performance:
10. The hospital has a process to communicate medication shortages and outages to licensed independent practitioners and staff who participate in medication management.
11. The hospital implements its process to communicate medication shortages and outages to licensed independent practitioners and staff who participate in medication management.
12. The hospital develops and approves written medication substitution protocols to be used in the event of a medication shortage or outage.
13. The hospital implements its approved medication substitution protocols.
14. The hospital has a process to communicate to licensed independent practitioners and staff who participate in medication management about the medication substitution protocols for shortages or outages.
15. The hospital implements its process to communicate to licensed independent practitioners and staff who participate in medication management about the medication substitution protocols for shortages and outages.
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