The ISPE Drug Shortages Team continues to work to assure the reliable supply of medicines to patients by developing actionable plans for the prevention of shortages resulting from manufacturing issues. ISPE’s 2013 Drug Shortages Survey has been universally well-received as a foundation for both action and more research and has led to the identification of ISPE as a partner for future collaboration in the US Food and Drug Administration (FDA)’s Strategic Plan for Preventing and Mitigating Drug Shortages. In recent months, opportunities to confer with other global regulators and industry leaders on drug shortages, their origins and potential solutions have increased.

ISPE was invited to present an overview of its survey findings to the European Medicines Agency (EMA) at a workshop attended by several pharmaceutical associations and patient groups in late 2013. The EMA noted that an effective drug shortages prevention plan would require a broad representation of industry experts and charged the associations in attendance with working together to develop and deliver a single, collaborative action plan for the prevention of drug shortages.

An Inclusive Task Force Formed

Recognizing the importance of collaboration to yield a singular approach, a Task Force was formed to address the prevention of drug shortages due to manufacturing quality issues. The Task Force is comprised of members from ISPE, the Parenteral Drug Association (PDA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), and the Plasma Protein Therapeutics Association (PPTA) was formed. The team also has participation from the EMA and six National Competent Authorities. Contributions by other associations are actively welcomed. By using the ISPE Drug Shortages Survey findings on the manufacturing quality causes of shortages, ISPE has taken a leading role in moderating and coordinating the group.

The Mission

The Task Force will focus on the quality system elements of drug shortages, including root causes, prevention and mitigation throughout the lifecycle, resilience of the supply chain and relevant training opportunities. The term “manufacturing quality issues” is defined as quality defects, failure of the manufacturing process and non-compliance with EU GMP or other EU quality requirements. The member associations have ongoing complementary activities in these areas; the joint task force will build upon and coordinate the unique perspectives and competencies of each organization. While there is a need to consider the totality of the supply chain, economic and market considerations are not within the scope of this group’s remit.

What the Task Force is Delivering

In Phase 1, completed in early January 2014, the Task Force performed an investigation and inventory of the respective associations’ plans and activities. In Phase 2, completed later that same month, the Task Force delivered a hi-level collaborative proposal with recommended outcomes and projected milestones to the EMA. The components of the proposal include:

  • Building a Robust Quality System
  • Improving the Corporate Culture
  • Implementing Metrics
  • Communication with Authorities
  • Optimizing CMC Post-Approval Changes
  • Business Continuity Planning
  • Publications, conferences, and workshops

Feedback to the Task Force’s proposal from the EMA to-date has been positive. The project is moving forward with discussion, information sharing and data gathering at the ISPE European Conference in Frankfurt on 28-30 April where representatives from the EMA, the National Competent Authorities, and all the participating associations are in attendance.

The Task Force’s Phase 3 deliverable, due to the EMA in November 2014, is an executable plan comprised of deliverables from each of the associations. A project duration of one-year is envisioned, with periodic reviews against the project plan and success criteria. Phase 4, to be informed by the results of Phase 3, will include training coordinated by the team and performed by the individual associations. Finally, in Phase 5, the Task Force will evaluate the number and/or extent of shortages within member states and across the European community to assess the impact of their recommendations and activities.

You Can Make a Difference

Both the FDA and EMA have recognized the need to look to industry for solutions, and ISPE has been uniquely positioned to integrate the industry’s response. ISPE Members and their companies have an unparalleled opportunity to contribute to the development of a collaborative, association-led drug shortages prevention plan by participating in discussions and providing input at ISPE events. The discussions with the EMA and the National Competent Authorities will form the basis of additional discussions and sessions to be held at the 3rd Annual ISPE-FDA CGMP Conference in June, and the 2014 ISPE Annual Meeting in October.

Complete information on the ISPE Drug Shortages Initiatives can be found here.