ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems

Abstract

Drug product shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors.1,2 Health care professionals are increasingly concerned about the clinical effect that shortages have on patients and the tremendous resources required to address shortages.3,–5 Adverse patient outcomes related to drug product shortages1,2,6,–9 have prompted aggressive management strategies by health care providers and gained the attention of the Joint Commission,10 the government,11,12 and the media.13,14 Drug product shortages adversely affect health-system finances by increasing the cost of delivering patient care, largely through higher drug acquisition and personnel costs.6 In addition, shortages create a high level of frustration for everyone involved, including purchasing agents, pharmacists, nurses, physicians, and patients.7 Managing drug product shortages is particularly complex for practitioners in hospitals and health systems (hereinafter, “health systems”), because these facilities routinely treat patients with acute or emergent conditions, use a significant number of medically necessary or single-source products, and use high-cost new drug technologies. These health care providers are challenged during drug product shortages to ensure the provision of seamless, safe, and therapeutically equivalent drug therapy, preferably at comparable costs. The pharmacy department must take a leadership role in efforts to develop and implement appropriate strategies and processes for informing practitioners of shortages and ensuring the safe and effective use of therapeutic alternatives. Strategic planning is required for managing drug product shortages, just as it is for disasters such as major weather events and mass-casualty incidents. Because a thorough understanding of why drug product shortages occur is essential for their successful management, these guidelines begin with a description of factors that contribute to or exacerbate shortages. The guidelines then describe a three-phase approach to contingency planning for management of drug product shortages and include strategies for prevention. Given the differences and complexities in health-system organizational arrangements and practice settings, some aspects of these guidelines may not be applicable in all settings. Pharmacy managers should use their professional judgment in assessing and adapting these guidelines to meet their needs. For the purpose of these guidelines, a drug product shortage is defined 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. Shortages can be the result of one or a combination of factors throughout the supply chain. The supply chain includes sources of raw materials, manufacturers, regulators, wholesalers or distributors, prime vendors, group purchasing organizations, and end-user health care systems. The factors that follow contribute to disruptions in the availability of drug products. Disruptions in the supply of raw or bulk materials are especially problematic when the primary or sole source experiences production difficulties or discontinues production, affecting multiple manufacturers. An estimated 80% of the raw materials used in pharmaceuticals comes from outside the United States.4 Availability problems can arise when armed conflict or political upheaval disrupts trade, animal diseases contaminate tissue from which raw materials are extracted, climatic and other environmental conditions depress the growth of plants used to produce raw materials, or raw materials are degraded or contaminated during harvesting, storage, or transport. Drug product shortages can also occur when the primary or sole manufacturer of a drug product halts or delays production in response to a Food and Drug Administration (FDA) enforcement action concerning noncompliance with current good manufacturing practices (cGMPs). Contributing factors may include antiquated manufacturing equipment, a shift of resources from maintenance of equipment and facilities to research and development, loss of manufacturer personnel experienced in production and compliance issues as a result of company mergers or retirements, cGMP-related problems with subcontractors who supply products to multiple pharmaceutical manufacturers, and limited FDA resources for timely inspections of manufacturing sites.4 Resolution of these issues is often a lengthy process and may include inspections to ascertain cGMP compliance, issuance of an injunction against the manufacturer, or seizure of products. In some instances, a manufacturer’s decision to close a specific manufacturing facility results in unintended drug product shortages. Such was the case when the sole source for hyaluronidase production closed, leaving no supplier.5 FDA enforcement actions are intended to protect the public from potentially unsafe drug products. These actions