Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is a founding member and contributing SME for the Duke Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium which has just published its first white paper on this complex topic. Lachman and the consortium are actively progressing multiple workstreams to address this issue. The first deliverable has just been published, “Advancing Federal Coordination to address Drug Shortages” and to increase your awareness, try reading this whitepaper as Step 1 (Advancing Federal Coordination to Address Drug Shortages (duke.edu)).

There is no lack of independent activities to address this issue, but this paper highlights a strategic plan for federal coordination. Efficiency and effectiveness are achieved from coordination and interdependence rather than competing siloed initiatives. One of the goals of the consortium is to bring focus to assist in aligning the momentum on this topic for a common goal. In considering the landscape of existing and forming initiatives, the following are some of the highlights identified as recommendations:

  • The federal government, in collaboration with the private sector, should support development and implementation of tools that measure supply chain reliability (including quality management maturity) for drugs at high risk of shortages.
  • The federal government should provide well-targeted incentives and support purchasing approaches that increase supply chain reliability.
  • The Prevent Drug Shortages (PDS) Initiative should be the keeper of fit-for-purpose lists of medicines used to guide policy and private-sector efforts regarding manufacturing and supply chain reforms to prevent drug shortages.
  • The federal government should pursue a proactive, coordinated focus on preventing the most impactful drug shortages, regardless of the cause.

These recommendations could also be read in light of the FDA’s response to the Committee on Energy and Commerce, dated May 9, 2023 (HMTG-118-IF14-20230511-SD006.pdf (house.gov)), which highlights the limitations that the FDA works under and quantifies the effectiveness of drug shortage reporting by industry. This all highlights the need for a strong public/private partnership to sustain gains made.

Lachman Consultants has frequently written on this topic as exemplified by a blog by Principal Consultant Pat Day (Supply Chain Risk & Data Management Poised to Take Leap Forward (lachmanconsultants.com)). Our goal is to help achieve the first goal in solving this problem, “awareness”; now let’s move onto coordination of goals and plans to get it done.