Tuesday, February 11, 2014

Study: Allocation Guidelines Needed As Oncology Drug Shortages Persist

A survey of American Society of Health-System Pharmacists members finds that oncology drug shortages are affecting patient care, prompting researchers to conclude there is a pressing need for guidelines to facilitate drug allocation decisions by clinicians. The findings come as the House Energy and Commerce health panel is slated to hold a hearing Monday (Feb. 10) to investigate FDA's response to drug shortages.

The survey was part of research conducted by ASHP, the Value Institute at Christiana Care Health System, the University of Pennsylvania and Fox Chase Cancer Center. The researchers say pharmacists also need help as they try to manage drugs in short supply.

"Support must also be extended to pharmacists who, while admirably leading efforts to manage short-supply and conservation protocols, should not be making allocation decisions without the support of their institutions' ethics committees or routinely participating in bilateral physician–pharmacist decisions posing a significant potential for conflicts of interests," they say.

The survey, published this week by the American Journal of Health-System Pharmacy, analyzed answers from 358 health system pharmacy directors throughout the country. Focusing on oncology drugs, the survey found that 98 percent of respondents reported at least one drug shortage during the previous 12 months. Further, 62 percent reported using alternative treatments, such as a different combination of drugs, because of the shortage.

"Our survey indicates that legislation introduced in 2012 to mitigate the occurrence and impact of drug shortages has yet to provide substantial relief to frontline clinicians, especially in the area of oncology drug shortages," according to the survey. "The care of cancer patients remains severely compromised."

The FDA Safety and Innovation Act included several mandates aimed at curbing drug shortages, including calling for a rule outlining requirements for companies to notify FDA about shortages. The agency is obtaining feedback on the proposed rule. The legislation also created the generic drug user fee program, which was expected to address the drugs primarily affected by shortages – generic injectable drugs.

An FDASIA-mandated Government Accountability Office report will be released Monday examining the cause of shortages and FDA's role in addressing them, the committee said. Douglas Throckmorton, FDA drug center deputy director for regulatory programs, and Marcia Crosse, GAO's health care director, are slated to testify at the Monday hearing. – Alaina Busch ( abusch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )

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