From Framework to the Frontline: Designing a Structure and Process for Drug Supply Shortage Planning

Abstract

Drug shortages are not new; they have been managed through conservation, procurement of alternatives, and redistribution of stock The Sandoz shortage in 2012 has caused a radical reduction of generic injectables. In Newfoundland and Labrador, our response has led to the development of the framework, structure, and process outlined in this paper. The efforts have eased the concerns of clinicians and leaders, as they are aware of the decision-making resource for situations of drug and technology shortage.

Why drug shortages are an ethical issue

“…As others have noted, addressing drug shortages will require "strong action" to promote legislative change, as well as local and international cooperation, transparency and accountability among stakeholders (including clinicians, policymakers, regulators, payers, patients and manufacturers) in both the prevention and management of drug shortages. 1,2,7,9,12,21,28,29 Unless value conflicts are explicitly acknowledged and managed, such cooperation is likely to be thwarted. sites, thus increasing the risk of manufacturing problems and drug shortages.…”

Why drug shortages are an ethical issue

“…More generally, institutions and governments may feel compelled to trade-off safety against access by, for example, allowing re-use of single-vials, allowing expired drugs to be used, allowing companies to use sub-standard or unapproved manufacturing processes, purchasing compounded or imported medicines that may be of poor quality or even counterfeit, or expediting regulatory approval of new medicines. 2,3,[9][10][11][12] In addition to harming individual patients, drug shortages are a threat to public health. Indeed, others have described drug shortages as a "public health crisis" because they threaten our ability to prevent and treat both acute and chronic diseases.…”

“…In some cases, priority needs to be given to those who are youngest or most ill, whose diseases are progressing most rapidly, who are most likely to benefit from therapy and/or who are on clinical trials. 5,9,19 Where such differentiation cannot be achieved, then "principled" decisions cannot easily be made to privilege one group over another, and other measures such as random allocation may be needed. 9 The need for such triage, and its ethical implications, has been recognised by many organisations, which have attempted to develop guidelines for resource allocation in the setting of drug shortages.…”

“…5,9,19 Where such differentiation cannot be achieved, then "principled" decisions cannot easily be made to privilege one group over another, and other measures such as random allocation may be needed. 9 The need for such triage, and its ethical implications, has been recognised by many organisations, which have attempted to develop guidelines for resource allocation in the setting of drug shortages. These guidelines have tended to emphasise the need for procedural integrity and justice, engaging all stakeholders-including clinicians, patients and managers-in decisions about how scarce resources should be allocated, and aiming for consistency, objectivity, transparency, accountability and clear methods for communicating decisions (for examples see references 9,17,19,[22][23][24].…”

“…9 The need for such triage, and its ethical implications, has been recognised by many organisations, which have attempted to develop guidelines for resource allocation in the setting of drug shortages. These guidelines have tended to emphasise the need for procedural integrity and justice, engaging all stakeholders-including clinicians, patients and managers-in decisions about how scarce resources should be allocated, and aiming for consistency, objectivity, transparency, accountability and clear methods for communicating decisions (for examples see references 9,17,19,[22][23][24]. It has also been noted that organisations have an ethical obligation to prepare for drug shortages by conserving supplies and by ensuring that the organisation is ready to respond to any shortage that arises.…”