Managing Drug Shortages: Seven Years' Experience at One Health

REPORTS Managing drug shortages REPORTS Managing drug shortages: Seven years’ experience at one health system ERIN R. FOX AND LINDA S. TYLER rug shortages have substantially affected patient care over the Abstract: A health system’s experience in therapeutic categories were central ner- past few years. While shortages monitoring drug shortages since 1996 vous system agents (24%) and serums, D within the organization and since 2001 on a toxoids, and vaccines (17%). Of the 119 have no single cause, manufacturing national level is described. shortages in 2001, 70 (59%) were still on- problems, regulatory actions, busi- Since January 1996, the Drug Informa- going as of the end of June 2002. The most ness decisions, and inventory prac- tion Service (DIS) at the University of Utah common potential safety problems were tices all contribute to the phenome- Hospitals and Clinics (UUHSC) has system- that clinicians might be unfamiliar with the non. Determining the true frequency atically prepared written bulletins to affect- alternative agent (54%) and that the alter- of drug shortages is difficult, in part ed practitioners when drug shortages native’s dosage requirement was different because “drug shortage” means dif- occurred. The DIS began providing infor- (50%). Over half of the shortages were cost ferent things depending on one’s mation on a national level to the American neutral, but the assessment did not include Society of Health-System Pharmacists in substantial potential indirect costs. perspective. Most health care organi- January 2001. Detailed information on drug shortages zations consider a drug shortage to A total of 224 drug shortages were collected by a health system’s drug infor- be a supply issue that affects how the tracked from January 1996 to June 2002. All mation service since 1996 indicated a trend pharmacy prepares a product or in- shortages at UUHSC were also national toward more frequent shortages. fluences patient care when prescrib- shortages, but only about two thirds of na- ers must choose an alternative thera- tional shortages also affected UUHSC. The Index terms: Central nervous system py. Manufacturers may consider a most common reasons for shortages were drugs; Costs; Dosage; Drug distribution; manufacturing problems (28%) and prod- Drug information centers; Manufacturing; drug shortage to be a problem with uct discontinuation (20%). The most Serums; Toxoids; Vaccines raw-material availability or a prob- frequently represented pharmacologic– Am J Health-Syst Pharm. 2003; 60:245-53 lem in manufacturing resulting in sustained unavailability of certain products. Wholesalers may define a that pharmacies face regularly. Fluc- frequency of industry back orders to shortage as difficulty obtaining a tuations in supply and demand pharmacies was 7%; by December product, regardless of the reason or among manufacturers, wholesalers, 2001, the rate had increased to 23% the duration. Often no distinction is and health care organizations occur (Streck RJ, Healthcare Distribution made between a back order and a daily but do not always constitute a Management Association Survey Re- shortage. For this article, we define a drug shortage. Pharmacies are adept search Program, personal communi- drug shortage from the perspective at dealing with these temporary sup- cation, 2002 Jan 31). of the health care organization. This ply issues. However, like drug short- Starting in 1996, the University of definition does not include the tem- ages, these fluctuations in supply Utah Drug Information Service porary back orders and supply issues have increased. In 2000, the average (DIS) systematically prepared written ERIN R. FOX, PHARM.D., is Assistant Professor (Clinical) of Pharmacy The Drug Information Service at University of Utah Hospitals and Practice and Drug Information Specialist and LINDA S. TYLER, Clinics develops and provides information on drug shortages to the PHARM.D., FASHP, is Professor (Clinical) of Pharmacy Practice and American Society of Health-System Pharmacists under a grant from Pharmacy Manager, Drug Information Service, University of Utah Novation. This information is available to the public at www. Hospitals and Clinics, Salt Lake City. ashp.org/shortage. Address correspondence to Dr. Fox at the Department of Pharma- cy Services, A-050, University of Utah Hospitals and Clinics, 50 N. Copyright © 2003, American Society of Health-System Pharma- Medical Drive, Salt Lake City, UT 84132 ([email protected]). cists, Inc. All rights reserved. 1079-2082/03/0201-0245$06.00. Am J Health-Syst Pharm—Vol 60 Feb 1, 2003 245 REPORTS Managing drug shortages memos for the affected practitioners at management strategies for the health group purchasing organization, University of Utah Hospitals and care practitioners likely to be affect- Novation. FDA’s “Orange Book” Clinics (UUHSC) when shortages ed. Shortages were identified by the (Approved Drug Products with Thera- occurred. The DIS had long involved buying staff in the department and peutic Equivalence Evaluations) and physicians in the management of sometimes by pharmacists. Once a National Drug Code Directory and in- drug shortages. It was important to shortage was brought to the atten- formation from our wholesaler were inform prescribers of drug shortages tion of the DIS, the staff reviewed the used to determine the manufacturers as soon as possible and to involve purchasing status with the buyers, and national drug codes of the prod- them in decisions when drug prod- obtained information from the ucts in question. The process of ucts needed to be allocated within wholesaler, contacted the manufac- contacting the manufacturers was the organization. This philosophy turer, and assessed our inventory. standardized. The customer service was developed in the late 1980s. Phy- Given that information, the staff as- department of each manufacturer sicians who understood that the sessed the potential for an impact on was contacted about the availability pharmacy had made every effort to patient care. If a potential existed, a of the drug product in question. If obtain a product were more likely to memo was prepared that outlined the customer service department work constructively with pharmacy the situation, how patient care might could not provide a reason for the to find appropriate solutions for be affected, and the clinical options shortage, the manufacturer’s medical managing shortages and preventing a practitioners should consider during information department and local negative impact on the patient. On the shortage. Every attempt was sales representatives were contacted. the other hand, prescribers who were made to involve prescribers and Manufacturers were contacted inter- surprised by supply problems were pharmacists with direct patient care mittently during the shortage until often unprepared to care for patients responsibilities in any decisions re- the product was widely available. in the context of a shortage. garding the allocation of a product in Shortage data from 1996 to 1999 Drug shortages came to the atten- short supply. The pharmacy and were collected from past UUHSC bul- tion of the American Society of therapeutics committee was respon- letins. Also, beginning in January Health-System Pharmacists (ASHP) sible for approving allocation proce- 2001, the data for shortages were en- beginning in the late 1990s.1-4 Mem- dures. Bulletins explaining why a tered into a spreadsheet (Excel, Mi- bers were informing ASHP about the shortage was occurring, the expected crosoft Corp., Redmond, WA). This dramatic impact that shortages were duration, and alternative agents or was necessary not only because of the having on their institutions. Two no- management strategies were distrib- dramatic increase in the number of table shortages during this time in- uted to prescribers, nursing manag- supply problems but also for tracking volved immune globulins and uroki- ers, and all pharmacy personnel. the shortages more consistently and nase. In response, ASHP prepared Originally, these bulletins were reliably. Information collected from guidelines on managing drug product printed and distributed manually. our bulletins and spreadsheets includ- shortages and developed a resource Later, the information was e-mailed ed the number of shortages docu- center on its Web site. to targeted practitioners. mented each year and, for each short- This article summarizes our expe- ASHP launched its Drug Product age, the product involved, the reason rience in monitoring drug shortages Shortages Management Resource for the shortage, whether the shortage since January 1996 within our organ- Center (www.ashp.org/shortage) in affected just the pharmacists or other ization and since January 2001 on a January 2001. The UUHSC DIS be- health care professionals also, the ther- national level. gan to provide clinical content for apeutic category, the level of impact on this Web site under a contract with patient care, and a safety and cost as- Methods ASHP and Novation. For this ar- sessment. Data on the impact on care, In January 1996, the UUHSC DIS rangement, the internal bulletins of safety, and cost that were not assessed began tracking drug shortages— UUHSC were adapted to a national at the time of the shortage were deter- supply problems that could affect pa- audience and potential shortages mined from the descriptions in our tient care or how the pharmacy were researched regardless of wheth- bulletins for shortages prior to 2001. would prepare the drug. Back orders er they would affect

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