Impact of Drug Shortages on Health System Pharmacies in the Southeastern United States

The increasing numbers of drug shortages in the United States and abroad have become far too commonplace. The number of medications on shortage lists tripled from 61 to 178 between 2005 and 2010, with over 200 reported in 2012 alone.1 As of March 2014, 754 drug products remain on shortage according to the US Food and Drug Administration (FDA).2 Shortages of critical drugs such as chemotherapy agents, analgesics, injectable nutritional supplements, anesthetics, anti-infectives, and cardiovascular agents are common.3–6 The primary causes for these shortages include inadequate raw materials, decreased number of manufacturers, and other factors that cause production to stall or be terminated.7,8 Delayed or lack of communication among the FDA, manufacturers, and health care providers may contribute to the inadequate preparation in managing drug shortages.1 The impact of drug shortages is multifaceted, with over 50% of health care practitioners believing that shortages have influenced practice and resulted in inferior patient care.9 A Canadian study from Hall et al relayed anesthesiologists’ opinions that drug shortages were responsible for prolonged recovery times, delayed surgical procedure scheduling, and increased recovery cost. Nearly half of them (49%) felt shortages were the impetus for the administration of inferior anesthetics.6 Drug shortages often impact vulnerable populations including cancer patients or neonates, for whom few, if any, equivalent alternatives exist; shortages may result in clinical complications, as exemplified by selenium shortages.10–13 Drug shortages may also force practitioners to prescribe infrequently used medications and concentrations, which can lead to medication errors as demonstrated with prior fentanyl shortages.6 Drug shortages have also impacted life outside of patient care; for example, a planned execution in Oklahoma was delayed due to a drug shortage.14 The financial impact of drug shortages in the United States is estimated at $99 million annually for acquisition costs alone.9 Many of the medications impacted by shortages are from generic manufacturers that hospital systems and third-party insurers depend on to provide cost-effective alternatives to branded products.1,7 Shortages not only impact drug costs but also productivity and efficiency. Pharmacist and nonpharmacist employees spend additional time procuring medications, identifying alternative therapies, and communicating with manufacturers about drug shortages. The problem has become so widespread that many hospital systems have hired pharmacy employees specifically dedicated to the task. 9,15 Rising costs and lack of availability may lead practitioners to reduce the waste of medications and to seek alternative ways to procure medications. Companies such as Pharma Tech recognize the time and financial impact of removing and discarding expired drugs from automated storage machines.16 With the help of software, institutions can safely and effectively remove expired drugs closer to their date to prevent wasting drugs on shortage. An alternative to procuring medications is to compound medications not readily available from raw materials. 8 Dependence on compounded forms of medications remains a high-risk practice, due to practitioners’ possible inexperience with specific compounds and serious complications resulting from contamination.17,18 Nine deaths occurred due to a break in the sterile process when alternative products were being compounded during an amino-acid shortage.19,20 Another high-risk method for obtaining limited medications is through the “grey market” in which middlemen obtain and sell scarce medications at highly inflated prices. The integrity of these drugs is unknown; some of them have been stolen or are counterfeit.21 Accreditation Council for Pharmacy Education (ACPE) standards and guidelines recommend that pharmacists in a hospital or health system pharmacy practice setting need to possess competencies in pharmacy systems, medication safety and quality, clinical applications, and professional practice. An example of performance competencies include the ability to describe the basic drug procurement process including drug selection, inventory management, back orders, recalls, drug waste, and handling of drug shortages and the relationship of shortages to safe, effective patient care.22 With drug shortages continuing at an alarming rate, the purpose of this study is to highlight the problems faced by health system pharmacies in the Southeastern United States, detail the response that is required to manage such shortages, and provide insight to circumvent future medication shortages.