The Drug Shortage Crisis (2011)

Historically, healthcare professionals would only occasionally be affected by a shortage of a drug and need to modify practice to accommodate patients until the supply returned to normal. This has changed remarkably and is especially true for parenteral nutrition (PN) products. In the past year, A.S.P.E.N. staff and volunteers have spent a considerable amount of time and resources responding to shortages of intravenous fat emulsions (IVFE), amino acids, vitamins (adult and pediatric), and more recently electrolyte additives for PN. There are several reasons for PN product shortages common to other drugs that make up the pharmaceutical supply chain, none of which appear to be resolving in a short period of time. An important problem with drug shortages is accurate and timely communication of information concerning the extent of the problem, its likely duration, and the impact the problem is having on patient care. Since the spring of 2010, A.S.P.E.N. staff and members have been enhancing our efforts to bring shortage issues to the attention of the U.S. Food and Drug Administration (FDA) as well as the manufacturers of PN products. Communication provided via A.S.P.E.N. web communications has been important in this process. In some instances, these communications were the first indications of a PN product shortage. Purchasing and securing PN additives Prioritization of patients Use of multi-electrolyte products Signs and symptoms of deficiencies Of particular concern to PN patients is the safety risk that is present because a PN ingredient is unavailable and therefore is omitted from therapy, or in order to maintain supplies, a dose is provided that is lower than recommended. Serious deficiencies have been reported during shortages of multivitamins1 and may occur during this shortage as well. Important to our continual ability to modify recommendations based on the individual circumstances and needs of our patients, we have partnered with the Institute for Safe Medication Practices (ISMP) and developed a mechanism to report problems resulting from PN Product Shortages. These reports are essential for us to identify systems and patient care issues that need to be resolved. We have also worked closely with the American Society for Health-System Pharmacists (ASHP) Drug Shortage Resource Center to continually update members, regulatory agencies and manufacturers of important issues that have resulted from PN product shortages. We all share in this crisis. Clinicians can and are making a difference by reporting PN product shortages, by communicating problems that have resulted from these shortages, by being vigilant with safety oversight of PN therapy in their organizations, and by using the A.S.P.E.N. PN product shortage recommendations as a guide to safe PN practices. Jay M. Mirtallo, MS, RPh, BCNSP, FASHP President, A.S.P.E.N. Director, MS in Health-System Pharmacy Associate Professor of Clinical Pharmacy The Ohio State University, College of Pharmacy Division of Pharmacy Practice and Administration Columbus, OH Supplementary data Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.