Medication shortages continues to be one of the most persistent, challenging issues faced by institutional pharmacists in recent years, with the severity of shortages creating significant obstacles to optimum patient care. Pharmacy, a frequently overlooked component of patient care service, has demonstrated considerable value in this role through safely managing drug substitutions and interchanges, as well as actively triaging criteria during emergency drug shortage situations.

The unpredictability of medication shortages has been a source of frustration at Carilion New River Valley Medical Center in Christiansburg, Virginia. Attempts to obtain more product from our wholesaler after a shortage is first identified are often fruitless; we may find that none is available, or that we can obtain only a fraction of the amount we require. While this situation leaves limited alternatives for redress, there are potential stop-gap initiatives that pharmacy can undertake to ameliorate the problem. 

Strategies for Mitigating the Effects of Shortages
A robust drug interchange system developed through the P&T committee can palliate some of the dangerous effects of shortages. If a product serving as a substitution then also experiences a shortage, the P&T committee can decide to reverse-substitute to the original product, provided that the original product is no longer backordered. Not every incident requires examination at the P&T level, however; shortages of less critical medications and those expected to be of short duration can be addressed safely at a lower level. A thorough understanding of triage processes should be in place so that physicians, nurses, and pharmacists are aware of their individual responsibilities throughout the duration of the shortage. Keeping an accurate list of current shortages and suggested alternatives at the physician’s order entry point, whether electronic or manual, is also an effective means of triage.

For critical medications and shortages expected to continue for the long term, allocating a drug to only one specific, emergent use is a prudent course. In such cases, physicians writing nonemergent orders should be required to select alternative therapies, if possible; the products that have no available substitutes would then be considered emergent. Facilities within one hospital system also may benefit from sharing inventory of shortage drugs, although borrowing controlled substances from a sister hospital can be a complicated process, involving filling out the DEA controlled substance order form (the DEA 222); both facilities must keep a copy on file. Because the DEA requires that the total number of dosage units shared not exceed five percent of all controlled substances distributed by the pharmacy that year, this method should only be used as a last resort. Centralization of short inventory is a common approach when inventorying medication in stock, however, it can also result in not having medications immediately on hand for emergencies. Centralization can be useful for ultra-critical medications that have no viable substitutions; these drugs should be centralized and dispensed only on a case-by-case basis to ensure they are available for patients in dire need. Maintaining and enforcing a robust IV to PO conversion program can alleviate some of the negative effects of drug shortages. Unless a patient is NPO, it is infrequent that IV would be indicated over an oral form, but in practice clinicians frequently order IV when it is not specifically indicated. Maintaining appropriate IV to PO policies and procedures (P&Ps) and regularly educating prescribing staff on these is necessary to ensure physicians are following protocol. 

Regardless of the approach chosen, fully vetting the options will best ensure that safety issues specific to the change are addressed. First-line agents are preferred over second-line agents for various reasons, but primarily due to their superior safety profiles. Awareness of the possible adverse events of using an alternative medication rather than a standard therapy and addressing any safety concerns immediately and proactively is vital. Ensuring early medical staff buy-in and understanding is critical for success, and will prove invaluable in helping to improve patient outcomes. Delineate information and decisions to the medical chairs, who are then tasked with educating their staff. If this method is less than successful, pharmacy may have to take a more aggressive approach: meet with the CEO and CMO of the hospital to gain their buy-in and have them reinforce the chosen shortages plan. Standard education is more likely to be effective if buy-in has occurred at this level.

Defining Appropriate Use of Emergent Drugs
While the volume of shortages keeps purchasing and drug information staff busy on a daily basis, determining the acuity of each shortage is of primary importance. Shortages of emergent drugs, such as fentanyl and midazolam, can cause potentially life-threatening dilemmas and must be carefully allocated. Fentanyl is used frequently in anesthesia, as well as in some pain management situations, and while preferable in some instances, it is not the sole option to treat either condition. Likewise, midazolam is only one of several benzodiazepines available, but given that diazepam and lorazepam also have been in short supply, judicious use of all drugs in this class has become paramount. 

Defining the appropriate emergency usage of these agents is vital, and P&Ps should clearly delineate when a specific treatment is allowable and when it is not (see sidebar). Is a particular anesthesiologist’s tendency to use fentanyl a reasonable delineation of emergent use if hydromorphone—or morphine in higher doses—may be a viable alternative? Should midazolam sedation be used for back spasms, or should this agent be reserved for use in a ventilator patient who is hypotensive? Pharmacy, in collaboration with the chief of anesthesia, must determine appropriate criteria and then enforce these decisions; otherwise, the drug might be completely unavailable when it is the only efficacious treatment. 

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Dissemination of Shortages Data 
It may seem that communicating a shortage to staff is as simple as adding a pop-up alert to order sets in the EMR. However, while alerts can sometimes be helpful, the magnitude of recent shortages, combined with the equally large number of current non-shortage therapy alerts, can easily cause alert fatigue. If not used judiciously, alerts become worthless because users simply ignore them. It is similarly impractical to continually manipulate order sets based on drug shortages, because a single medication in the EMR can be included in dozens—if not more than 100—order sets. Unless the shortage is substantial and long-term, other means of addressing it must be employed; otherwise an entire team of IT professionals will be required simply to make order set alterations in a timely manner. 

One effective method of delineating information is to place a master alert of only the day’s new shortages at the EMR login that  physicians must view before proceeding. This ensures physicians are aware of new shortages on a daily basis, but does not overburden the alert system and workflow process for pharmacists, physicians, or the IT department.

Bar code scanning is a key component of the patient safety net, especially in the event of a product substitution. For example, if a unit dose syringe is already bar coded in the system for a medication that is now on backorder, but ampules of the same size and strength are available, two methods can be employed to ensure accurate scanning and patient safety with bar code–driven verification. If your EMR platform has the capacity to group related NDCs together under the same code, the best solution is to have IT load the bar code of the ampule under the same code as the syringe. This ensures that the billing department has the correct NDC so that the product will be charged accurately when scanned. Alternatively, if your EMR does not allow this approach, the ampule will need to be added to the system separately as a new product—which can be time-consuming—to ensure it scans correctly. 

Conclusion
Managing medication shortages is a distinctly complex challenge involving various factors, and finding immediate solutions to this problem is unlikely. Utilizing all the tools at our disposal is critical to minimize the negative effects of shortages on patient care; the occurrence of adverse drug events should not drive the ultimate solutions to this critical issue. Pharmacists, physicians, and nurses must communicate around this matter and collaborate to discover potential solutions. Drug shortages will continue to complicate patient care until industry consolidations and regulatory issues have been thoroughly addressed and remedied. 

L. David Harlow III, BS Pharm, RPh, is the regional director of pharmacy operations at the Carilion Clinic in Christiansburg, Virginia, and the director of pharmacy at Carilion Clinic New River Valley Medical Center.