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ISPE Offers Platforms to Progress Continuity of Supply of “Essential” Medicines

ISPE Drug Shortages Initiative Core Team
ISPE Offers Platforms to Progress Continuity of Supply of “Essential” Medicines

Meaningful business continuity planning is the outcome of appropriate and strategic application of risk-benefit evaluations. It is unsustainable to have a backup for every resource, activity, and component required for pharmaceutical manufacturing. Therefore, it is vital that the pharmaceutical industry prepare for business continuity in a manner that provides the greatest assurance of continued supply of critical medicines to patients.

To this end, many associations, pharmaceutical manufacturers/suppliers and Health Authorities have been working toward identifying “essential” medicines, which could become foundational for business continuity planning in the pharmaceutical industry. Nevertheless, the result has been the generation of a range of expectations.

Criteria for Identifying “Essential” Products

Globally harmonized criteria for identifying “essential” products with significant patient impact would be beneficial, however, the criteria differ across organizations or Health Authorities. For example, the World Health Organization (WHO) defines essential medicines as those that "satisfy the priority health care needs of the population.” The European Medicines Agency (EMA) defines critical medicinal products based on therapeutic use and availability of alternates. The United States 21 C.F.R. §356c categorizes life-saving medicines requiring risk management plans as “ life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency...”, and as of last month is working toward an essential medicines list. Additional complications in identifying “essential” products are presented by products that may have different clinical indications and use across markets, and the potential for biased interpretation of criteria by the private sector.

Challenges with an “Essential” List(s)

Marketing Authorization Holders may benefit from having globally accepted “essential” medicines lists to drive the development and successful use of business continuity plans, and “essential” lists established between health agencies and industry products may significantly improve response to natural disasters or pandemics. The challenges to establishing such lists include the difficulty in creation and maintenance, and that they may generate medical treatment limitations if they only include certain dosage forms (e.g., oral vs. injectable). Moreover, their value can be diminished if too many products are included.

Global Harmonization

Global harmonization on the definition of “essential” medicines would be a positive step in providing common focus toward mitigating and preventing significant drug shortages in the future. Utilizing a staged approach to harmonization and beginning with a subset of organizations and/or markets, such as the WHO, ICH, PIC/S, HMA/EMA, ICMRA, US FDA, etc., would provide valuable, initial progress in this area.

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 provide options for risk mitigation.

ISPE efforts and industry progress in the area of drug shortages would be profoundly improved and generate more successful business cases and continuity plans, if the starting question of which products to prioritize for business continuity measures could be clearly and consistently answered globally.

ISPE and its Drug Shortages Initiative Team of industry experts is prepared to provide platforms for discussion with appropriate government or regulatory agencies in support of global harmonization activities regarding defining “essential” medicines that would be beneficial to the industry and the patients they serve.


ISPE Drug Shortages Initiative Core Team

Diane L. Hustead
Director, Regulatory Affairs
Merck & Co., Inc.
Chair
James Canterbury
Principal, Consulting
Ernst & Young LLP
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Dawn Culp
VP Regulatory Affairs
Hikma
Nasir Egal
Vice President, Global Quality
Sanofi
Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, A Member of the Roche Group
Melissa Figgins
Executive Director
Quality Executive Partners
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Erin Fox, Pharm D
Senior Director, Drug Information & Support Services
University of Utah Health
Donna Gulbinski
Chief Quality & Reg Affairs Officer
Civica, Inc.
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Emma Harrington
Executive Director Quality
Sandoz Inc., Broomfield Manufact.
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Karen Hirshfield, RPh
Director, Enterprise Regulatory Compliance
Johnson & Johnson
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Drishya Nair
LifeSciences Advisory Consultant
Ernst & Young
Terrance Ocheltree, PhD, RPh
Head Regulatory and Quality Assurance
Corium International Mfg Group
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Deborah Tolomeo, PhD, JD
Global Compliance
Genentech Inc
Sumanth Venugopal
Partner
PricewaterhouseCoopers LLP

ISPE:

Jean-Francois Duliere
Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
Christopher John Potter, Ph.D.
CMC Pharmaceutical Consultant
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Carol M. Winfield
Senior Director, Regulatory Operations
ISPE
Thomas Zimmer, PhD
VP, European Operations
ISPE