Coping With Critical Drug Shortages

Abstract

The number of critical medication shortages in the United States has reached an unprecedented level, requiring decisions about allocating limited drug supplies. Ad hoc decisions are susceptible to arbitrary judgments, revealing preformed biases for or against groups of people. Health care institutions lack standardized protocols for rationing scarce drugs. We describe the principles on which an ethically justifiable policy of medication allocation during critical shortages was created at our hospital. Based on supportable scientific evidence and with all clinically similar patients treated as similarly deserving of consideration, drugs were distributed according to a hierarchy of clinical need and predicted efficacy. We explain the ethical rationale for the procedures we adopted, how the policy was implemented at a large academic medical center, and more than 1 year of experience with a number of different medications. Our experience has demonstrated the feasibility and utility of formulating a rational and ethically sound policy for scarce resource allocation in an academic teaching hospital that could be used in a variety of health care settings. The method has proven to be reliable, workable, and acceptable to clinicians, staff, and patients.

Caring for the Suffering: Meeting the Ebola Crisis Responsibly

“…Health care providers would then be forced to select which among the many to help with specific interventions. Of course, there would be questions in how this prioritization and allocation would be done, and it is to be hoped that a procedure could be developed beforehand that could be fair, equitable and transparent (Daniels 2000;Rosoff 2012;Rosoff 2014;Rosoff et al 2012). Any attempt to craft an ethically justifiable rationing system should give due consideration to the existing inequities in the epidemic societies and try to mitigate them to the extent that is possible.…”

Prescribing With an Empty Pharmacy

“…Any drug shortage protocol should possess the ethical pillars of transparency and openness and be clinically relevant, and all decisions resulting from policy enactment should be amendable to appeal. 10 A drug shortage protocol should also include the pragmatic concerns surrounding medication therapy. First, in situations of absolute drug scarcity, maximizing efficiency of drug distribution can be accomplished by conservation methods such as having all eligible patients arrive the same day to minimize waste from single vial use.…”

“…If 2 clinically equivalent patients need a care agent, and there is only enough drug for 1 person, a coin toss could be used to decide. 10 Having an available decision model that addresses all the aspects of drug shortage that includes procurement, distribution and allocation is the better path for patients, clinicians, and organizations. 10,11 This ''homeland security plan'' for drug shortages should also include compassion for patients and families seeking to obtain a drug in lifedeath situations.…”

“…10 Having an available decision model that addresses all the aspects of drug shortage that includes procurement, distribution and allocation is the better path for patients, clinicians, and organizations. 10,11 This ''homeland security plan'' for drug shortages should also include compassion for patients and families seeking to obtain a drug in lifedeath situations. 12 Travel to other countries, paying incredibly high prices in nonlicensed markets, or inability to accept rationing or triage are just some of the desperate responses clinicians must face with understanding, education, and support.…”

Applicability of Guideline Recommendations Challenged in the Setting of Drug Shortages

“…Although health systems are continuing to develop ethical approaches in the management of drug shortages, the critical care community will look to experts in PAD for alternative treatment options (6). Although health systems are continuing to develop ethical approaches in the management of drug shortages, the critical care community will look to experts in PAD for alternative treatment options (6).…”