As noted in the report, which is required under the Food and Drug Administration Safety and Innovation Act of 2012, the agency has taken to working with manufacturers to help prevent shortages and to weaken the impact of those that do occur. Accordingly, the agency’s Center for Drug Evaluation and Research (CDER) has used a number of tools, including “regulatory flexibility when appropriate,” to prevent 140 shortages from Jan. 1 to Sept. 30, 2013, the period covered in the inaugural report. One focus of its efforts is to promote and to sustain manufacturing quality. The agency also explained how early notification on the part of manufacturers provides additional time to identify ways to maintain treatment options.
Previously, the FDA has cited quality/manufacturing issues as the major reason for shortages. However, other causes, including production delays and postponements in receiving raw materials, also contribute to shortages. Regarding another factor, discontinuation, the agency notes, it “…can't require a firm to keep making a drug it wants to discontinue.” Among the issues: Fewer firms make the older, sterile injectable drugs, and suppliers must limit the amount of raw material they produce due to their own storage capacity problems. Add to this the complexity and long lead times involved in manufacturing, and all these factors combined result in greater vulnerability to shortage. Along with patients, pharmacists are also affected by drug shortages and in a recent study, researchers report rather shocking results.
SafetyIn a study released earlier this month, researchers from the University of Pennsylvania and other institutions discovered that oncology drug shortages continue to have a significant impact on patient care. The researchers surveyed 358 pharmacy directors across the U.S., and what they were told might surprise you.
During the previous 12 months, 98 percent of respondents experienced at least one drug shortage while 63 percent said their facility had completely run out of at least one injectable oncology drug. More than half — 62 percent of respondents — reported using alternative drug regimens due to the shortages, such as changing the combination of drugs used to treat a specific cancer drug or using a different combination of drugs. The respondents also reported making the following treatment changes due to shortages:
Changing the drug dose (46 percent)