iSpeak Blog

Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

Diane L. Hustead
Drug Shortage Prevention

In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of the global audience.

The panelists were:

Mélanie Cachet
Deputy Director of the Inspection Division
ANSM
Nasir Egal
VP, Regulatory Quality Compliance
Lisa Hedman
Senior Advisor
WHO Division of Access To Medicines and Health Products (MHP)
Diane L. Hustead
Senior Director, Regulatory Affairs
Merck & Co., Inc.
Valerie E. Jensen, CAPT (Ret.), RPh
Associate Director, Drug Shortage Staff
CDER/FDA

A wide range of drug shortage prevention topics were reviewed, and contemporary challenges were surfaced. A case in point, feedback obtained from a poll of the audience indicated that while quality challenges may remain as a significant contributor to drug shortages, the complexity and vulnerability within supply chains, exacerbated by the conditions of the COVID-19 pandemic, has created equivalent or greater concerns for maintaining supply continuity.

Drug shortage prevention initiatives have predated the COVID-19 pandemic; however, their importance has been magnified by the global impact and extended outlook of the pandemic that is moving into a second year without a clear end in sight. The open dialogue during this webinar highlighted the remarkable progress health authorities and industry have made to address supply resiliency challenges from a variety of perspectives. Notably:

  1. Health authorities applied mutual reliance more than ever to leverage the work of other trusted health authorities and increased efforts to utilize distant assessments for the benefit of faster product approvals or post-approval changes.
  2. Health authority interactions to mitigate or prevent drug shortages were pivotal during the pandemic and may expand to address lessons learned and the panel discussion highlighted:
    • While drug shortage reporting helped health authorities focus on critical pandemic needs, there are recognized limitations with available drug shortage-related data. For greater ability of health authorities to help industry avoid significant supply disruptions, drug shortage reporting requirements are likely evolving.
    • Regulatory Flexibility continued to assist with mitigation and prevention of drug shortages (e.g., accelerated reviews, enforcement discretion, implementation of temporary importation of product from other countries…etc.) and the disruptive events during the pandemic demonstrated the tremendous value in this flexibility. Focusing forward, an openness to generate more standardized or global approaches to regulatory flexibility was expressed to ensure the greatest agility and resiliency may be obtained during large-scale unpredictable events.
  3. The ongoing journey to enhance manufacturing practices to address drug shortages was also discussed in this forum, with an emphasis on two areas:
    • Pursuit of Quality Management Maturity (QMM) continues with an intent to elevate manufacturing practices beyond baseline cGMP. Achieving QMM is expected to result in a more consistently uninterrupted supply of medicines for patients and a QMM rating could become an important mechanism for greater of transparency of a companies’ supply reliability.
      • ISPE’s Advancing Pharmaceutical Quality (APQ) program - a quality management maturity program based upon ICH Q10 – is designed to determine and advance the maturity of a firm’s Pharmaceutical Quality System.
    • Guidance and templates for business continuity planning to prevent drug shortages were discussed and an openness to generate more standardized or global approaches expressed. The insight shared could provide timely information due to the evolving regulatory requirements in multiple markets. It was acknowledged that business continuity plans to prevent drug shortages ideally include a blend of traditional measures (redundancy and stockpiling) and manufacturing agility through regulatory or operational mechanisms.

Beyond the lens of health authority and manufacturing activities, information was shared regarding the remarkable progress being made with respect to predicting when drug shortage events may occur, referenced as predictive modeling herein. Predictive modeling of potential drug shortages typically relies on publicly available industry data (e.g., manufacturing locations, number of manufacturers, product indication, complexity of manufacturing…etc.) to determine the potential for a particular drug shortage event to occur. It also presents a significant opportunity to draw conclusions from markets that have higher visibility into drug-shortage-related data to assist with markets that have lower visibility. Having greater insight to potential shortage events for all markets, creates the opportunity for more holistic plans for drug shortage mitigation and prevention activities that could improve the global equity of drug availability.

Lastly, predictive modeling does require sorting through the various definitions for shortages that have evolved organically through the different health authorities’ expectations and drug shortage prevention measures. While it was noted in the discussion that the diversity of the current definitions can provide richness to the data behind predictive modeling, ISPE sees an opportunity to harmonize key definitions for supply disruptions and priority of medicines to ensure the quite-often limited resources available for mitigating and preventing drug shortages are most effectively applied.

In summary, COVID-19 has created impact to the supply chain in an unprecedented scale and recharged attention on improving business continuity planning and related activities to prevent drug shortages. Regulator and industry experiences during this difficult time have provided great insights that we all can leverage for the remainder of the pandemic and into the future.

As a leading not-for-profit professional society dedicated to scientific, technical, and regulatory advancement of pharmaceuticals, the International Society for Pharmaceutical Engineering (ISPE) has been instrumental for more than a decade in facilitating communication among the different sectors of the pharmaceutical industry and global Health Authorities related to drug shortages, including the six dimensions of the ISPE Drug Shortage Prevention Plan that outline the key areas of opportunity for risk mitigation.

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Disclaimers

This is an abridged, unofficial summary of regulators’ remarks during the webinar that has not been vetted by any regulator or agency. The content is an informal and brief synopsis of discussion during the webinar and does not represent official guidance or policy of any agency or regulatory organization.

iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.