Duke policy provides ethical foundation for managing drug shortages

Hospitals and health systems faced with ongoing shortages of key drugs for cancer and other diseases should develop firm rationing policies based on transparency and fairness, researchers at Duke University Medical Center report.

In a Special Article published online Monday, Sept. 24, 2012 in the , the Duke team outlined a policy adopted at Duke Medical Center that established clear-cut rules for apportioning scarce drugs using a hierarchy of clinical need and effectiveness.

Built on similar models that govern some organ donations, the Duke approach was written by the hospital's ethics committee and adopted by hospital leadership in 2011 as shortages of critical drugs occurred regularly.

In recent years, the U.S. has announced hundreds of supply problems for lifesaving , , and other drugs. Dozens of pharmaceuticals are on the shortage list at any given time, forcing doctors to switch patients to alternatives, delay treatments or cut dosages.

"There's no reason to believe things will get better and, in fact, they may get worse, so hospitals will have to deal with some very dicey issues," said Philip M. Rosoff, M.D., M.A., director of at Duke and lead author of the study. "For that reason, it's important to establish and follow an ethically defensible policy for how scarce resources are rationed."

In their article describing the development and implementation of the Duke Medical Center policy, Rosoff and co-authors outlined five essential components:

  • Rules were transparent and open to review both internally and externally;
  • The policy and its rationale were relevant, clinically necessary and clearly stated;
  • Patients and doctors had a path for appeal;
  • Rules were followed and enforced by all and for all;
  • No patient or doctor was allowed special consideration.
Rosoff said fairness was an especially important component of the policy.

"One of the issues that arises is the question of so-called 'special people,'" Rosoff said. "What if a major donor comes in, or someone who says they'd like to be a major donor? Does that person step to the front of the line? Our policy says no – all patients are treated equal."

While each shortage was unique, Rosoff said having the policy provided a uniform approach to managing different situations. When drugs were flagged as running low, hospital officials immediately responded by taking inventory of remaining stock, determining when and how additional supplies might become available, reducing waste and paring back on usage.

One tactic was to restrict scarce drugs for FDA-approved uses, or in circumstances with firm, scientific evidence of benefit. As a result, a agent approved solely for breast cancer could not be used "off label" for other types of cancers unless there was strong published evidence to support it.

Hospital officials also strategically scheduled patients who needed the same drugs on the same day, pooling the small leftover amounts in single vial containers to reduce waste.

In certain critical shortage situations, Duke also had rules giving priority to existing patients, new patients from the immediate referral region, and patients who could be cured by the drug.

Rosoff said Duke's experience could be instructive to most other institutions, but noted that the hospital benefitted from having a compounding pharmacy, which enabled it to produce many scarce drugs when raw materials were available. He said that capacity created additional ethical dilemmas, requiring strong communication and cooperation with surrounding hospitals.

"We had to make some difficult decisions, most of which we foresaw in the creation of the policy," Rosoff said. "There have been several issues we thought could happen, but haven't happened yet, so in that sense, it's been very gratifying."

add to favorites email to friend print save as pdf

Related Stories

The private sale of drugs in public hospitals

Feb 08, 2010

Governments are under increasing pressure to provide access to expensive new drugs. Canadian patients who want access to drugs that are not publicly insured are seeking to pay for these drugs within public hospitals, states ...

FDA: New suppliers to ease 2 cancer drug shortages

Feb 21, 2012

Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages - at least for the time being - that have patients worried about missing life-saving treatments.

Recommended for you

Health care M&A leads global deal surge

15 hours ago

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.