DRUG SHORTAGES

To declare that pharmaceutical manufacturers, distributors, group purchasing organizations, and regulatory bodies, when making decisions that may create drug product shortages, should strive to prevent those decisions from compromising the quality and safety of patient care.

Rationale

Drug product shortages continue to be a critical issue because of their frequency, duration, and widespread nature. Although the effects of drug product shortages on patient care and pharmacy services are complex and have not been comprehensively described, the negative effects include increases in (1) patient safety risks, (2) drug expenditures due to higher prices paid for noncontract or alternative product supplies, (3) physician dissatisfaction and patient dissatisfaction, and (4) staff time spent resolving shortage problems. Pharmacy managers are hampered in addressing shortages by the lack of any advance notice of shortages from manufacturers, group purchasing organizations (GPOs), distributors, or the Food and Drug Administration (FDA); limited information regarding the estimated duration of shortages; and limited information on the reasons behind the shortages. Further, managers lack immediate information on what options are available (i.e., alternative sources of products or appropriate therapeutic alternatives) to ameliorate the problem on both a short- and long-term basis. In addition, the concerted effort to decrease inventories across the drug supply chain leave little buffer when drug product shortages occur.

Drug shortages occur for a variety of reasons, including manufacturer noncompliance with FDA's Current Good Manufacturing Practices, natural disasters that damage production plants, shortages of raw materials, increases in unlabeled uses, consolidation within the industry, predetermined production quotas, and market shifts driven by large purchasers and payers. A significant factor affecting product supply is business-related decisions made by the key players in the drug supply chain. These decisions, and the limited information pharmacists are able to retrieve regarding shortages, has harmed the trust between pharmacists and the pharmaceutical supply industry. ASHP believes that these key players, including pharmaceutical manufacturers, GPOs, distributors, and regulatory bodies must consider the impact that their decisions affecting supply and demand of a product have on the quality or safety of patient care.