All of sudden, the mainstream media - highlighted by a high-profile NewYorkTimespiece 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.
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.
For example, when the drug shortage involves a generic product, the FDA works with other firms making the drug to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw-material sources approved to help increase supplies. The FDA can and does expedite review of these to help resolve shortages of medically necessary drugs.
But the FDA can’t require the other firms to increase or commence production.
The agency tries to do the best it can with limited authority, spare resources and shared staff. In addition to direct communication with industry, the Drug Shortage Program also gets reports from health care professionals, patients and professional organizations using the email address firstname.lastname@example.org.
But, as you can imagine, there is not a lot of email traffic. And there is no social-media effort to promote the program’s purpose or existence.
The Institute for Safe Medication Practices reports that in a survey of 1,800 health care practitioners, more than half said they frequently or always encounter difficulties associated with drug shortages.
The top three problems fall squarely within the zone of appropriate FDA attention and action:
c Little or no information available about the duration of a drug shortage (85 percent).
c Lack of advanced warning from manufacturers or the FDA to alert practitioners of an impending drug shortage and suggested alternatives (84 percent).
c Little or no information about the cause of the drug shortage (83 percent).
Survey respondents felt “unsupported by the FDA and are perplexed regarding why the U.S. is experiencing drug shortages of epic proportion that are often associated with third-world countries.”
Should the issues of both authority and funding for the FDA’s efforts to mitigate drug shortages be hung on the Prescription Drug User Fee Act Christmas tree, which authorizes the FDA to collect fees from companies that produce certain drug or biological products, or addressed in separate legislation? Either way, it’s an issue that must be addressed with alacrity before it becomes a question of American lives.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
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