Drug Shortages

For far too long shortages have occurred with many classes of drugs and the impact on patients has been significant: treatment delays, the use of less effective treatments, or missed doses of therapies, often with life-threatening results. Patient access to needed drugs can mean the difference between life and death.

Shortages are systemic and have long-lasting impacts on patients, health systems, and future innovation. Policymakers, regulators, industry, payors, health systems and other stakeholders must act to identify and respond to the risks and vulnerabilities in the medicines supply chain – with a goal to ensure patients have access to the therapies they need.

Drug shortage task force

The undersigned organizations issued a Call to Action to mitigate and prevent drug shortages in the United States.

Alliance for Aging Research

American Cancer Society Cancer Action Network

Angels for Change

American Pharmacists Association

Arthritis Foundation

American Society of Health-System Pharmacists

Association for Clinical Oncology

Cancer Support Community

Friends of Cancer Research

Generics Access Project

Hemophilia Federation of America

Howard University College of Pharmacy

Susan G. Komen

National Consumers League

National Psoriasis Foundation

United States Pharmacopeia (USP)

Systemic solutions

Actions should address both short-term and long-term needs and include risk mitigation strategies, public and private investment and partnerships, payment reform to reward reliability and manufacturing quality, coordination and accountability, and policy reforms. Major areas include:

Coordinate supply chain resilience and reliability efforts

Medicines supply chain resilience and reliability activities should be coordinated among federal agencies and non-governmental stakeholders. Coordination efforts should include the organization of multi-disciplinary efforts, defining measurable outcome metrics for implementation efforts, and strategic planning activities to maximize the utility of new programs and increase the impact of existing initiatives. Additionally, necessary authorities and sufficient funding should be allocated to lead these cross-cutting efforts to improve drug supply chain resilience and reliability.

Increase supply chain visibility

A critical need exists to invest in early warning capabilities that signal threats to and vulnerabilities within the pharmaceutical supply chain. Recent and ongoing shortages in oncology drugs have made clear that while data signals exist that can help predict upstream pharmaceutical supply chain risk, the data are not integrated in a way that can generate actionable insights to prevent or mitigate drug shortages.

Establish a vulnerable medicines list

A need exists to establish a vulnerable medicines list in the United States, as a complement to or a component of already established essential medicines lists, which factors in supply chain vulnerabilities. A vulnerable drugs list would be continually updated to reflect conditions that may increase the likelihood that a particular medicine could go into shortage.

Align the market to incentivize a quality and adequate supply chain

Policymakers and public and private drug purchasers should establish and utilize payment and purchasing models that value and incentivize supply chain quality, resilience, and reserves for drugs vulnerable to shortages. This will require developing or adopting objective metrics of quality, resilience, and reserves to drive these incentives.

Bolster manufacturing capacity

Policymakers should consider a range of reforms to foster more security in the manufacturing base for U.S. drug products to reduce the risk of disruptions and shortages. Some possible reforms include economic or other incentive measures that will encourage multiple suppliers for key drugs, geographic diversification of manufacturing facilities, and manufacturing location and component supply redundancies. Additionally, the development of tools and standards can help reduce technical barriers and facilitate wider adoption of advanced manufacturing technologies (AMTs) that have the potential to improve manufacturing efficiency, reduce production costs, reduce environmental footprints, and support supply chain resilience.

Research to better understand market interactions

To better understand the root causes of persistent drug shortages, non-biased and nonpartisan research into the complex market dynamics associated with generic medicines is necessary. Targeted pilots or demonstration projects can test interventions on a limited scope before scaling more broadly.

Conclusion

A fundamental shift in the market for lower-priced drugs is needed to align supply and demand forces to create a predictable, sustainable, and high-quality supply chain that can reliably provide critical drugs to patients. Policymakers and public and private drug purchasers must value quality and resilience through sustainable prices of drugs that demonstrate these characteristics. While the programs and policies to achieve this are being developed and implemented, there will continue to be a need in the near term for better tools to understand supply chain vulnerabilities and shortage risks, and ways to proactively intervene in a coordinated manner.

Only by addressing both the short-term and long-term aspects of this issue will we be able to minimize impacts of the ongoing drug shortage crisis.

Download this call to action