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," US experts have said.
Reporting this week in the Archives of Internal Medicine, researchers from Duke University Medical Center outline a policy adopted at the Center which has established clear-cut rules for apportioning scarce drugs, using a hierarchy of clinical need and effectiveness.
In recent years, the US Food and Drug Administration (FDA) has announced hundreds of supply problems for lifesaving chemotherapy agents, pain medications, antibiotics and other drugs, the researchers note. Dozens of medicines are on the shortage list at any given time, forcing doctors to switch patients to alternatives, delay treatments or cut dosages, they add.
"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. For that reason, it's important to establish and follow an ethically defensible policy for how scarce resources are rationed," said Philip Rosoff, director of clinical ethics at Duke and lead author of the study.The Duke approach to tackling drug shortages is built on similar models that govern some organ donations, and its five essential components are that:
- rules are transparent and open for view, both internally and externally;
- the policy and its rationale are relevant, clinically necessary and clearly stated;
- patients and doctors have a path for appeal;
- rules are followed and enforced by all and for all; and
- no patient or doctor is allowed special consideration.
Fairness is an especially important component of the policy, said Dr Rosoff."One of the issues that arises is the question of so-called 'special people.' 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," he said.
While each shortage is unique, having the policy provides a uniform approach to managing different situations, he noted. When drugs are flagged as running low, hospital officials immediately respond by taking inventory of remaining stock, determining when and how additional supplies might become available, reducing waste and paring back on usage.
One tactic is to restrict scarce drugs for FDA-approved uses, or in circumstances with firm, scientific evidence of benefit. As a result, a chemotherapy agent approved solely for breast cancer cannot be used off-label for other types of cancers unless there is strong published evidence to support it.
Hospital officials also strategically schedule patients who need 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 has rules giving priority to existing patients, new patients from the immediate referral region, and those who could be cured by the drug.
Duke's experience could be instructive to most other institutions, said Dr Rosoff, but he noted that the hospital benefits from having a compounding policy, which enables it to produce many scarce drugs when raw materials are available. Capacity creates additional ethical dilemmas, requiring strong communication and cooperation with surrounding hospitals, he added.
- Meantime, a senior FDA official has reported that the agency has tracked about 100 drug shortages so far this year, compared with 251 for the whole of 2011 and 181 for 2010.