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Drug Shortages

Volume IV, Number 6 | November/December 2001

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There have been numerous drug shortages throughout the nation that have affected many healthcare institutions, and The Cleveland Clinic Foundation is no exception. Healthcare professionals have faced constant short-term backorders and long-term unavailability of products, potentially causing a significant impact on public health. A drug shortage may occur when: 1) the total supply of all versions of the approved product available will not meet the current demand and 2) a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.

The pharmaceutical manufacturing industry continues to be a factor in drug shortages. Mergers of companies may lead to the discontinuation of products or a delay in production. There may be difficulty in obtaining raw materials or a change in raw materials which may hinder product production. Often times there is only one or two suppliers of a raw material, and if issues arise with one of the manufacturers, the remaining supplier may have difficulty meeting the increased demands. Additionally, medications that are difficult to produce may also be at risk for frequent drug shortages. For instance, there is an increased demand for drugs in the biotech industry which may potentially lead to patient distribution programs (e.g., etanercept {Enbrel®}) to ensure an adequate supply is available. Finally, changes in production, marketing decisions, company revenues, and changing or increasing the use for old drug products, may also affect the availability of medications from manufacturers.

The FDA also contributes to drug shortage problems by increasing the enforcement of good manufacturing practices. The FDA may request that a manufacturing plant close for repair and maintenance which can slow or stop production of a product. If the drug is considered a medical necessity, the FDA will become involved in the management of the drug shortage. A product is considered medically necessary if it is used to treat or prevent a serious disease or medical condition, and there is no other available source to manufacture that product or an alternative drug is judged to be inadequate.

Frustration has been an inevitable result of the most recent drug shortages and backorders. A lack of suitable alternative agents, the use of unfamiliar substitutes, patient safety concerns, and a lack of advanced warning of impending shortages have been noted as major concerns. Also, the financial impact of purchasing alternative agents, and the additional time to research alternative medications factor into the frustration of drug shortages.

The impact of patient care and safety is the biggest concern for healthcare professionals. Dosing errors, adverse events, and suboptimal therapy are all potential pitfalls of the reoccurring drug shortages.

More often than not, drug shortages are due to distribution problems. However, the above mentioned problems do exist, and as healthcare professionals there is a need to know how to handle them.

Part of the responsibility of reporting a drug shortage is from the manufacturer. Healthcare professionals should be informed as soon as a drug shortage or backorder is anticipated. There are two Websites that can be accessed to find out why there is a shortage and what are alternatives therapies. The American Society of Health-System Pharmacists (ASHP) drug shortage Website (www.ashp.org), lists the drugs in short supply, as well as providing suggestions for alternative therapy, whereas the FDA Website (www.fda.gov), lists the drugs in short supply along with the reason for the shortage. Another site to check is the Department of Pharmacy stock out update on the CCF Intranet. This web site is only accessible to people within the Clinic.

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Copyright © 2000-2017 The Cleveland Clinic Foundation. All Rights Reserved.
Center for Continuing Education | 1950 Richmond Road, TR204, Lyndhurst, OH 44124