Drug Shortages: 10 Ethics Rules for Hospitals

When precious medications run low, how should clinicians decide who should get the benefit?

That's the thorny question clinicians at Duke University Medical Center are attempting to answer with an ethically defensible drug rationing plan which aims to help healthcare providers make fair and equitable choices.

"This plan obeys a simple, straightforward set of rules for fairness and allocation that was vetted by a large number of people—physicians, nurses, social workers, ethicists as well as community members and patient representatives," says Philip Rosoff, MD, Duke's director of clinical ethics and the principal investigator of the Duke project.

In an attempt to avoid providers making decisions that favor VIPs such as "a donor, the brother-in-law of the chief medical officer or the mayor," versus the VUP, the person with no insurance, Rosoff says, the policy stipulates explicitly that "there are no special people. Does that mean we wouldn't come under pressure? We could. But it's written into the policy of the hospital, so the downside is that violating that could mean one helluva lawsuit."

All too often, at Duke and other hospitals, he says, these decisions have been made on an ad hoc basis, "with different people involved each time, and each time reinventing the wheel. It was increasingly apparent this was not the best way to do it, but we lacked the structure and rigor for a procedure for how" to make these decisions.

The 10 "accountability for reasonableness" steps are outlined in the Archives of Internal Medicine.  They are as follows:

1. The policy must be transparent and open to anyone for review.

2. It must be relevant to the population of patients and healthcare providers affected by its application.

3. There must be a system by which people can appeal a decision they think is wrong.

4. The institution that has the policy must implement it and assure that everyone follows the rules

5. The allocation of the drug must be fair, in that clinically similar patients are always treated similarly, "with no 'special' people, physicians, or patients" receiving exceptional consideration.

6. Duke has an advantage in that it has a compounding pharmacy which enables the organization to formulate drugs that are in short supply, but using them quickly in patients being cared for by Duke's healthcare system may mean foregoing sterility testing.  Patients who receive such drugs must sign consent.

7. An ironclad rule prohibits purchasing medications from "gray market" vendors "because we can not assure a proper chain of custody or the integrity of the medication, although using these medications could give the appearance of lessening the gravity of the shortage."

8. Prohibit use of drugs deemed to be in short supply in research studies.

9. Take a weekly inventory of 20 unique oncology agents and a daily inventory of 70 to 100 non-oncology drugs that could be in short supply.

10. When a drug is scarce, patients may be asked to receive the drug on the same day "to minimize wastage from single-use vials" through safe practices.

Finally, Rosoff says, in the rare events in which two clinically equivalent patients need a drug for which supply is only sufficient for one, "a coin will be tossed to choose between them."

The issue is increasingly a controversial one because of unpredictable shortages, especially involving expensive drugs that sometimes find their way into other routes of sale, the so-called grey market. Sometimes raw materials are contaminated, or there are quality issues with the manufacturing process, or the manufacturer just decides to discontinue production.

In an accompanying editorial, Paula Rochon, MD, and Jerry Gurwitz, MD, of the Women's College Research Institute in Toronto say Rosoff and his colleagues "serves as a wake-up call to clinicians to become better educated about and more engaged in the issue of drug shortages.

"Clinicians need to be vigilant about reviewing the drug shortage alert they receive because these alerts may directly affect their patients and their plans for patient care," they wrote.