Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Industry perspectives were given by Susan Mountain, Regional Supply Chain Lead, Amgen; and Diane Hustead, Executive Director Regulatory Affairs, Merck and chair of the ISPE Drug Shortages Initiative Team. The webinar was attended by more than 100 participants globally with insightful questions and comments raised during the panel discussion.
The webinar started with a presentation from Diane Hustead on the ISPE team’s progress from 2013 to present which has focused on how to guide the industry, learn, and improve for better drug shortage prevention and continuous supply to patients. An overview of the global regulatory landscape and regulatory expectations and guidelines with respect to drug shortages were also presented. A preview was given of the new ISPE Drug Shortages Prevention Model in which drug shortage prevention focus areas such as quality and manufacturing, regulatory and technology, and innovation align with ISPE’s Communities of Practice and other resources. Diane concluded by informing the audience that the ISPE Survey on Business Continuity Planning for Drug Shortage Prevention related to generics is still open. Companies interested in participating in the survey can send an email to regulatory@ispe.org.
Large-scale events have put a spotlight on global supply chain vulnerabilities which were emphasized by the Covid-19 pandemic. Monitoring global shortages during emergencies is difficult to obtain, especially on low visible markets as emphasized by Lisa Hedman representing the WHO. Four risk categories were developed, each with a series of risk factors relating to supply relative to demand. These risk factors were used to monitor drug shortages during the early phase of the pandemic by weekly polling of countries and regions. Lisa then explained how analytics from databases in different countries and how predictive modeling was continuously explored and developed by WHO using clinical risk factors to establish equitable allocation across low- and middle-income countries (LMICs). Lisa mentioned that there had been some trade restrictions with some LMICs withholding drug products and active pharmaceutical ingredients (APIs). For the future, this suggests that WHO should be involved in political activity to minimize trade restrictions and to consider stewardship to make sure allocated stocks are properly dispensed and used.
A background on the history of the WHO portal and the development of the global reporting system was also presented. Through the portal, data and information could be obtained and processed with the aim of addressing the lack of data to and from low-visibility markets and to better understand the magnitude of the global problem. Risk levels for different regions and countries of which categorization and definitions are analyzed to improve understanding on shortages. Having common definitions is proving to be a challenge, although to some extent it is also an opportunity since it can provide additional information. Generally, Lisa indicated that improving definitions applied to categorization of portal data would be a great benefit.
Joyce Cirunay, Philippines FDA, provided an excellent foundational overview of the core regulatory aspects of drug shortage prevention. Joyce highlighted how well the Philippines FDA understood the factors relating to drug shortages from both the demand and supply sides. She particularly highlighted that supply chains are global with increased competition for API from different drug product manufacturers. Potential solutions discussed included use of prioritization measures and effective stakeholder interaction. Stakeholder discussions included coordination, communication, transparency and promoting dialogue between stakeholders at the national, regional, and global level. Joyce also emphasized the need for harmonization, especially for emerging economies. Global harmonization of processes (e.g., reporting) and definitions will assist in the global reporting system, giving easier access to data on drug availability and shortages, especially to LMICs. Joyce concluded by stressing the global need for coordination, communication, and transparency.
Assuring quality suppliers versus cost was emphasized by Susan Mountain of Amgen. She emphasized the need for regulatory communication and collaboration. Regulatory approvals, particularly for post approval changes and consideration for timelines are critical since long lead times may lead to delay or even inaccessibility of supply to patients. She also discussed the importance of risk management across the whole supply chain. An organizational culture of innovation and continual improvement supported by corrective and preventive planning should mitigate interruption of supply. For a globally supplying company, the importance was stressed of a global planning network linking manufacturing supply with individual country demand. Amgen had a policy of not allowing drug shortage. In line with other speakers, Susan also emphasized the importance of communication, both internally across the supply chain and externally to customers and regulators when necessary or required.
There was an active Q&A session as well as a series of polling questions, all of which indicated strong interest and engagement from the audience. Drug shortages are a global problem with significant impact on patients and healthcare systems. Themes raised during the webinar were that drug shortages are brought about by multifaceted factors that need multi sectoral collaboration from stakeholders; innovative pathways should be continuously considered to mitigate drug shortages, and that finding solutions and establishing best practices are critical to ensuring patients have access to safe, effective, quality medicines.
Disclaimer
This article contains an abridged, unofficial summary of presentations and discussion during a virtual event on 9 February 2023. This content has not been vetted by any regulatory agency, represents an informal and brief synopsis of regulators’ views, and does not represent official guidance or policy of any regulatory agency or authority.
