Researchers Propose Standards for Managing Drug Shortages

By Jennifer Larson, contributor

October 5, 2012 - When critical drugs are in short supply, how does your organization handle it?

A recent study from a team of researchers at Duke University Medical Center proposed a set of ethical standards for hospitals and health systems who are coping with the struggle to manage drug shortages. The basic premise of the policy is the idea of fairness.

“The idea is that there are no ‘special’ people,” said Philip M. Rosoff, MD, director of clinical ethics for the Trent Center for Bioethics, Humanities and History of Medicine at Duke, and the lead author on “Coping with Critical Drug Shortages: An Ethical Approach for Allocating Scarce Resources in Hospitals,” which was published online on September 24, 2012, for the Archives of Internal Medicine.

How shortages create a problem  

Drug shortages occur for a variety of reasons, ranging from delays, discontinuations, manufacturing and quality problems, according to the Food and Drug Administration (FDA). And they “create a high level of frustration for everyone involved, including purchasing agents, pharmacists, nurses, physicians and patients,” noted the American Society of Health-System Pharmacists (ASHP) in a 2009 paper that outlined a series of guidelines for managing drug product shortages.

“As long as the pharmaceutical manufacturing and distribution system in the United States remains a completely commoditized entity in which the US Food and Drug Administration has little or no power to regulate the market to minimize the chances of unexpected and severe medication shortages, we will be left with the challenge of how to apportion the remaining sock when demand outstrips supply,” wrote Rosoff.

While manufacturers are not required to provide information about drugs in short supply, many now voluntarily provide information to the FDA, which maintains an index of ongoing drug shortages.

And that has helped, according to a column written by FDA Commissioner Margaret Hamburg, MD, in May. She reported that an executive order signed by President Barack Obama in late 2011 to encourage manufacturers to report impending drug shortages and other potential disruptions in drug supply has had a positive impact. The order also required reporting of discontinuations of certain drugs.

“Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers. Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur--42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year,” Hamburg wrote.

However, experts expect that shortages will continue; Hamburg wrote that the FDA expects them to “remain a complex, serious problem.”

The ethics of allocating drugs in short supply

The policy described by Rosoff et al. in the Archives of Internal Medicine grew out of the “accountability for reasonableness” process that was described by Norman Daniels and James Sabin in the 1990s. (They also co-authored a 2002 book titled Setting Limits Fairly: Can We Learn to Share Medical Resources?) Rosoff also wrote an article in early 2012 for the American Journal of Bioethics that contributed to this study.

When Daniels described the process necessary for the fair allocation of scarce resources, he called for four conditions: publicity, relevance, appeals and regulation. The decisions must be accessible, and they must be relevant. There must be a mechanism for challenge, and there must be some type of regulation to ensure the other conditions are met.

Similarly, the policy developed by the Duke team has five essential tenets, the first four of which are similar to the “accountability for reasonableness” policy but with an addition:

  1. Transparency: the policy--and the development and implementation of the policy--must be open to everyone for review
  2. Relevance: the policy and its rationale must be judged clinically relevant--“and those reasons should be rationally acceptable by others”
  3. Appeals: there must be an appeals process where a person can challenge a decision
  4. Enforcement: everyone must follow the rules, and the institution must ensure that’s the case
  5. Fairness: no “special” person will receive exceptional consideration.

Cynthia Reilly, director of the ASHP’s practice development division, noted that it’s especially important during drug shortages to use evidence-based guidelines when deciding how to treat patients. Some patients can successfully take alternative medicines to the ones in short supply, but others cannot, and that can provide guidance.

And she cited the benefit of the transparency requirement in the Duke policy, too.

“You want people to understand how these decisions came about, whether evidence-based guidelines were used,” Reilly said. “There is such an emotional component to this that you wouldn’t want to give the impression that a certain service or a certain physician was receiving favoritism, so the more open you are about how you came to a decision, the less likely you are to run into those types of impressions.”

How the policy is working

Reilly said pharmacists have been coping with drug shortages for over a decade, and by now most have good processes in place to handle making recommendations for alternative treatments. But there’s always room for refinement, and it’s a good idea to be prepared ahead of time for ethical questions that might arise. 

Duke implemented the policy created by Rosoff’s team about 18 months ago, and so far it has worked out well, Rosoff said.

“We have not yet been confronted with a situation where the first cousin, twice removed, of the chief of medicine needs a drug and there’s some poor person on Medicaid or an uninsured person who’s an undocumented immigrant who needs the same drug, and we have one dose and two people,” he said.

But in that sort of situation, Rosoff hopes that the fairness doctrine would prevail.

“I think there would (be) a lot of pushback, if somebody tried to make an exception,” he said.

He noted that one question that remains unanswered is “Do we have a greater loyalty to people who live close to the hospital, as opposed to people who live far away?” That is still to be determined.

For more information:
Coping with Critical Drug Shortages: An Ethical Approach for Allocating Scarce Resources in Hospitals,” Archives of Internal Medicine.