The Experience and Consequences of Drug Shortages
AMA members have been contacting the association with increasing frequency since early 2001 to complain about drug product shortages. A substantial number of physicians suspect there may be market manipulation behind at least some of the shortages.
A report to the AMA House of Delegates at the December 2001 interim meeting identified many reasons for drug shortages. In preparing that report, AMA held discussions with FDA, the Pharmaceutical Re-search and Manufacturers of America, and ASHP. Among the report's recommendations was to ask the secretary of the Department of Health and Human Services to establish a task force to explore the causes of drug and vaccine shortages and identify appropriate solutions based on the input of stakeholders. As part of this initiative, the Secretary would commission research by experts to identify solutions to the underlying problems.
AHA receives many communications from state hospital associations and hospitals about drug shortages. Economic pressure on hospitals has resulted in reduced inventories of drugs and less flexibility to respond to shortages. Hospitals are more sensitive to shortages and to the cost of alternatives and are reluctant to buy "off contract." Hospitals are frustrated by the limited ability of the federal government to address some of these issues. They are concerned about how medically necessary drugs are defined and frustrated that regional shortages are not addressed in the same way as national ones.
ASHP saw a dramatic increase in communications from members about shortages in 1999. Some pharmacy directors had difficulty believing that routinely used products were unavailable nationally. Substantial amounts of staff time were being devoted to tracking back orders and seeking alternative sources. As the number of back orders increased and inventories diminished, members complained about the lack of information available from manufacturers, wholesalers, and FDA. They needed to know if the shortage of a given product was real, why there was a shortage, how long it might last, if there were alternative sources, and if there were any acceptable alternative therapies.
ASHP met with FDA representatives in December 1999 to express members' concerns about drug product shortages. Subsequently, FDA staff participated in a presentation at the ASHP Annual Meeting in June 2000, where many pharmacy practitioners learned about the farreaching effects that shortages were having on patients, physicians, pharmacists, nurses, and hospital administrators. Pharmacists, in collaboration with physicians, were making choices about conserving and rationing remaining inventories. Some patients were receiving suboptimal care. Medical procedures were being delayed or canceled, and patients' hospital stays were being prolonged. Medication errors and adverse drug reactions were occurring when other therapies had to be used in place of an unavailable drug. The risk of errors is increased, because providers might be unaware that alternative drug products, even within the same therapeutic category, have differences in strength, dosage, time to onset of action, and duration of action, among other variables. An example of this problem was the use of sufentanil when fentanyl was unavailable. Many other opiate agonists could have been used, but some practitioners used sufentanil, which is more potent than fentanyl. Some practitioners assumed that they should give the same number of micrograms of sufentanil as of fentanyl; as a result, some patients received an overdose.
Other anecdotes were described that illustrate the serious consequences of shortages of lifesaving drugs used in emergencies. These included
The difficulty of a level 1 trauma center in obtaining succinylcholine, a rapid-acting neuromuscular blocking agent used in positioning endotracheal tubes for emergency airway management,
Patients' suffering when methylprednisolone was not available for treating acute back pain from slipped disks, and
Unavailability of ephedrine to treat hypotension during surgery. Phenylephrine had to be used but was a poor substitute because it is less selective.
Pharmacists are spending increasing time communicating with pharmaceutical manufacturers and sup-pliers about drug product shortages. Within their institutions, pharmacists are having to take time to provide inservice education about alternative therapies and proper dosage and administration in order to minimize the potential for errors in patient care.
In 2001, ASHP entered into an agreement with the University of Utah Drug Information Service (UUDIS) to use bulletins developed by UUDIS to address pharmacists' questions about shortages. Also in 2001, ASHP published guidelines on managing drug product shortages and launched a Drug Product Shortages Management Resource Center on its Web site (www.ashp.org/shortage/). The resource center includes: (1) drug product shortage bulletins that provide, for specific drug products in short supply, information about availability, alternative agents, and management; (2) availability of drug products experiencing some supply discruptions; and (3) an e-mail link for reporting drug product shortages to ASHP. Since its launch, the resource center has received about 60 reports of shortages each month. More than 50 products are currently represented in shortage bulletins on the site, and information about availability is provided for another 20 products.
UUDIS had reports of shortages of 80 products in 2001, compared with 20 or fewer in preceding years. Nationwide, shortages of 120 products were reported in 2001. A nationwide shortage may not affect every facility, depending on the facility's patient population and what drugs the institution has under its contracts.
In 2002, data available through June seem to indicate fewer shortages than in 2001. Shortages of fewer than 25 products were reported to UUDIS, and fewer than 40 nationwide. However, many of the shortages reported in 2001 and 2002 have been of long duration. In July 2002, 57% of the 2001 shortages and 70% of the 2002 shortages were ongoing.
Usually there is no advance warning of a widespread shortage. The first indication of a shortage to a health-system pharmacy may be a fax from a company stating, "We have drug X available" -- usually at a cost far higher than that charged by the pharmacy's usual source. This suggests to pharmacy directors that a product may be in short supply and that they may need to order an additional supply. It is difficult to obtain information on how long a shortage will last and on good sources of other products that might be used in place of a product that is unavailable. Using alternative sources is often time-consuming and costly to the health system.
For pharmacies and health care organizations as a whole, drug shortages increase purchase costs. At one 800-bed hospital, purchases of alternative products and purchases off contract caused a $25,000 per month increase.
Increased staff time to deal with shortages is also costly. Health care professionals' time is being reallocated; some institutions have one half to one full-time-equivalent position devoted to monitoring and addressing shortages. Pharmacists are spending additional time educating physicians and other providers about alternative drug products and proper dosing and administration.
There may be no available alternative for a drug in short supply. When there is an alternative, the quality of a product is usually acceptable; however, the quality of a product purchased from a distributor of unknown reputation may be in question. Compounding a product or purchasing a compounded product that cannot be obtained commercially also requires extra safety precautions.
Am J Health Syst Pharm. 2002;59(22) © 2002 American Society of Health-System Pharmacists
Cite this: Provisional Observations on Drug Product Shortages: Effects, Causes, and Potential Solutions - Medscape - Nov 01, 2002.
