In the past five to 10 years, drug shortages have become increasingly prevalent and are now commonplace in the healthcare arena. The impact is vast and extends far beyond lack of a given drug for a given patient. It is important to identify the origin of drug shortages and the overall impact on both the patient and the healthcare organization, in particular, the academic medical center. In addition, staying abreast of current drug shortage information and potential therapeutic alternatives is paramount for critical care practitioners.

In November 1997, the United States experienced the start of an ongoing shortage of intravenous immune globulin (IVIG). From that time period to present, shortages of medications, particularly those that impact critical care settings (e.g., IV antibiotics, IV corticosteroids, neuromuscular blockers) have persisted. Several reasons have been attributed to these drug shortages, including manufacturing, discontinuation of products for economic reasons, supply/demand imbalance, raw material shortage, and regulatory issues. Of particular frustration is the discontinuation of products purely based on economics (i.e., low-cost generic products). The Food and Drug Administration (FDA) has no authority to force manufacturers to continue to produce a product even in the best interests of the public. However, it has been strongly advocated to the FDA to provide incentives to companies to continue the production of less profitable, routinely used medications.(1)

The impact of a drug shortage is extraordinary and often involves compromised patient care and clinical outcomes, as well as an increased risk for medication errors. Most often, therapeutic alternatives are identified in times of a drug shortage, which creates a scenario where medications utilized are less familiar, may be inappropriately dosed and monitored, and/or delays in treatment occur usually due to communication inefficiencies to healthcare providers.

For example, the ongoing shortage of methylprednisolone has necessitated the use of other parenteral steroids (also sporadically unavailable due to the increased demand). While therapeutically equivalent for the majority of indications, these drugs are dosed differently, have varying stabilities and IV push rates of administration. Unfortunately, this variability creates an environment for error. For example, the unavailability of parenteral prochlorperazine has led to an increased use of parenteral trimethobenzamide. Although prochlorperazine may be administered IV push, trimethobenzamide can only be given intramuscularly. It can be anticipated that a clinician might inadvertently administer trimethobenzamide intravenously when he/she considers it the alternative to prochlorperazine.

In addition to patient outcome, healthcare professionals continue to be concerned about the tremendous resources needed to address each and every shortage. These concerns may be magnified in large, academic medical centers due to the sheer numbers of professionals to inform, as well as those needed to develop a rapid consensus regarding alternatives. Typically, a shortage is either identified by a pharmacy purchaser or via communication in professional societies. From this point forward, it is necessary to carefully investigate the validity of the information, the potential impact on patients in specific medical centers based on current use, supplies available, and anticipated shortage duration.

Once this information is evaluated, the problem-solving exercise becomes more clinically oriented and less focused on drug procurement. Although not a function exclusive to the Pharmacy and Therapeutics (P&T) Committee, such a group is a logical choice for coordinating development of therapeutic alternatives and methods for communication to the healthcare staff. Addressing the shortage and appropriate alternatives must occur quickly and, if limited supplies are available, a plan to restrict use or pool supplies is often immediately required. Medical centers must proactively identify designated personnel (e.g., P&T chairperson, pharmacy director, pharmacy purchaser, etc.) to coordinate this process. A proactive approach and streamlined process is especially needed to facilitate resolution of drug shortage issues involving critical care medications.

Although the academic medical center may have specific challenges due to the larger numbers of medical personnel, centers with multiple sites, specialties and services also have some advantages. When drugs are subject to limited distribution, all sites/services can purchase a given allotment, yet pool supplies for the most critical needs. For example, methylprednisolone may be acquired by an obstetrics hospital, but reserved for spinal cord injury for its “sister” trauma hospital. Penicillin might be purchased by all adult sites, but reserved for neonates at a sister site. In addition, professionals at academic centers are likely networked with colleagues around the country and can seek assistance regarding alternatives that can eliminate unnecessary duplicative work.

Fortunately, a number of online resources can assist in providing current information regarding shortages and recommended therapeutic alternatives. These include the FDA, www.fda.gov, the Centers for Disease Control and Prevention (CDC), www.cdc.gov, and the American Society of Health System Pharmacists (ASHP), www.ashp.org. Despite these advances, drug shortages continue to plague an already overstressed inpatient healthcare environment. They exhaust precious healthcare personnel resources, are costly and most importantly, can be detrimental to patient care.