Clinical need, effectiveness, fairness should drive drugs allocation

By Sarah Guy, medwireNews Reporter

A policy that is transparent, fair to patients and healthcare providers, and is based on clinical need is an ethically justifiable approach to rationing drugs that are in critically short supply, report researchers.

The initial response to such shortages should minimize wastage, then equivalent substitutions should be used where possible, and local compounding pharmacies - where available - should replenish stocks, suggests the team.

"Although our approach is preliminary and revisions will undoubtedly be required as we gain experience, we have created a mechanism to ration scarce resources in a just and equitable manner, with sufficient stability and flexibility to respond to this ongoing crisis," remark Philip Rosoff and colleagues from Duke University Medical Center in Durham, North Carolina, USA.

Writing in the Archives of Internal Medicine, the team explains that many healthcare institutions lack standardized protocols for rationing scarce drugs, and deal with rationing decisions on an ad hoc basis. This has the potential for "major abuses" in which some patients are deemed more deserving of drugs than others, the authors suggest.

The team developed a guideline policy for their institution based on "accountability for reasonableness" and implemented it over a 1-year period.

The policy incorporates the principles of transparency, its development and implementation are open to all for review, it is clinically relevant to all parties affected by it, stakeholders are able to appeal against decisions they feel are wrong, the institution must guarantee its implementation, and no patients or physicians will receive special consideration.

"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," said Rosoff in a press statement.

Over a 1-year period at their institution, the researchers encountered a shortage of the chemotherapeutic agent bleomycin, used in Hodgkin's disease and germ cell tumors. Eligible patients attended the clinic on the same day to avoid wastage from single-use vials, and a small enough new supply was maintained to treat existing and anticipated new patients (from the region).

Furthermore, no therapy was initiated in patients for whom a complete course of treatment was in doubt.

"Common themes to successful management of drug shortages include comprehensive communication across all affected providers and early identification of emerging supply issues," the researchers conclude.

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