Dangers of Worsening Drug Shortages; Remedy Unavailability Could Start Costing American Lives

The Washington Times (Washington, DC), August 29, 2011 | Go to article overview

Dangers of Worsening Drug Shortages; Remedy Unavailability Could Start Costing American Lives


Byline: Peter J. Pitts, SPECIAL TO THE WASHINGTON TIMES

All of sudden, the mainstream media - highlighted by a high-profile New York Times piece by bioethicist Dr. Zeke Emanuel - has discovered the problem of drug shortages. Except it's not a new problem. According to a recent analysis, the frequency and impact of drug shortages have risen to critical levels - more than tripling since 2005 - and shortages affect all segments of the health care sector. In 2010, more than 240 drugs were either in short supply or unavailable and more than 400 generic equivalents were back-ordered for more than five days. In most instances, these did not progress to critical shortages, but they point to instabilities in the supply chain that cause national concern. Many of the drugs identified in 2010 remain unavailable or in short supply in 2011. Seventy-seven percent of drugs in short supply in 2010 were sterile injectable products - critical in the acute care setting. Recent media coverage highlights the plight of patients and physicians faced with shortages for cancer drugs, anesthetic agents and critical care medications that have contributed to delays in treatment and surgery or changes in care plans. Drug back orders cause patients to receive substitute therapies that add expense to patient care.

Among the major reasons for shortages are manufacturing-quality issues. However, there are other reasons, such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuation is another factor contributing to shortages.

It is time not to fix the blame but to fix the problem. Let's start with the Food and Drug Administration (FDA).

In 2010, 178 drug shortages were reported to the FDA. Is that a solid number? It's hard to say because current regulations do not require companies to notify the FDA of shortages. The only requirement is that companies inform the FDA six months in advance for discontinuations of sole-source medically necessary drugs.

In 2010, for example, 38 shortages were prevented by companies voluntarily notifying the FDA of potential issues that could lead to shortages; the agency was able to work with the companies to avoid shortages.

Inside the FDA's Center for Drug Evaluation and Research resides the agency's Drug Shortage Program. The program was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation and negotiation, the program works with pharmaceutical manufacturers, and components of FDA to manage product shortages. …

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