Building Resilience into the Nation's Medical Product Supply Chains (2022) / Chapter Skim
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Appendix B: Summary of Recommendations from Contemporary Reports
Appendix B: Summary of Recommendations from Contemporary Reports
Pages 261-276
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From page 261... ...
health care sector ° Use trade tools to counter unfair trade practices and strengthen the public health industrial base needed for national security ° Sustain a supply chain workforce with the people and skills needed for pandemic preparedness Agility and Innovation • Build a more capable and robust Strategic National Stockpile and expand state, local, tribal, and territorial stockpiling 1 For more information on these recommendations and to read the full report, see https:// www.phe.gov/Preparedness/legal/Documents/National-Strategy-for-Resilient-Public-HealthSupply-Chain.pdf (accessed October 7, 2021)
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From page 262... ...
government public health supply chain workforce • Revise Executive Order 13603 on National Defense Resources Preparedness • Establish a national framework for allocation of constrained resources • Revamp global governance of the public health supply chain BUILDING RESILIENT SUPPLY CHAINS, REVITALIZING AMERICAN MANUFACTURING, AND FOSTERING BROAD-BASED GROWTH2 Boost Local Production and Fostering International Cooperation • Investment and Financial Incentives to Boost Production ° Leverage the DPA and Current Public–Private Partnerships (PPPs) to Establish a Consortium for Advanced Manufacturing and On-shoring of Domestic Essential Medicines Production ° Near-Term Next Steps: n HHS and the White House will host a high-level summit on drug supply chain resilience to kick off this new initiative.
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From page 263... ...
n HHS will map the supply chains for the Critical Drug List to the resilience framework for a robust supply chain and identify those for which on-shoring or near-shoring may be advisable. n HHS will determine if there is a need to increase production or stockpile APIs for the Critical Drug List, and if so, iden tify the amounts needed in such a stockpile, the benefit and risk of a virtual stockpile, and the ability to use platform technologies to provide surge production in crises.
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From page 264... ...
° Near-Term Next Steps: n HHS will convene a working group to analyze how reim bursement policies contribute to the lack of resilience for sterile injectables identified in the previous proposal as well as chemotherapeutics that have been in shortage in the past 5 years. n HHS will evaluate whether certain sterile injectables that are identified as being at significant risk of shortage but are not part of the Critical Drug List medicines identified above, such as sterile pediatric oncology drugs, should also be the subject of improved supply chain resilience work in addition to drugs on the Critical Drug List.
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From page 265... ...
It will develop a strategy for the secretary on how to facilitate a wider adoption of novel methods for commercial production of pharmaceuticals and biologics. • Create Quality Transparency ° Create a Rating System to Incentivize Drug Manufacturers to Invest in Achieving Quality Management Maturity ° FDA should lead the development of a framework to measure and provide transparency regarding a facility's quality man agement maturity with engagement from industry, academia, and other stakeholders.
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From page 266... ...
n The following are several critical sources of new data neces sary to support such surveillance work: o Drug manufacturing volume information and reporting; o Complete registration and listing requirements; o Distribution data on prescription drugs and certain bio logical products; o Requiring manufacturers to notify FDA of an increase in demand; and o Requiring that the labeling of API and finished product labeling include original manufacturers. ° Next Steps: n HHS will convene industry and other nongovernmental stakeholders to share insight on commercial data sources and to encourage stakeholders across the supply chains to increase their use of commercial data to improve supply chain resilience.
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From page 267... ...
n As part of this analysis, HHS will explore stockpiling strat egies to reduce API supply risk, including an analysis of KSMs. Promote International Cooperation and Partner with Allies • Ensure International Harmonization for Reviewing and Respond ing to Supply Chain Risk with Partnering Nations ° The U.S.
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From page 268... ...
o Several stakeholders maintain information sources that, if combined, could shed more light on the extent of drug shortages and their potential effects on the health system. 3 For more information on these recommendations and to read the full report, see https:// www.fda.gov/media/131130/download (accessed October 7, 2021)
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From page 269... ...
Recommendation 2: Create a Rating System to Incentivize Drug Manufacturers to Invest in Achieving Quality Management System Maturity • This proposal aims to rectify this failure by suggesting the devel opment of a system to measure and rate the quality management maturity of individual manufacturing facilities based on specific objective indicators. A rating would evaluate the robustness of a manufacturing facility's quality system and could be used to inform purchasers and GPOs about the state of, and commitment to, the quality management of the facility making the drugs they are buying.
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From page 270... ...
DRUG SHORTAGES: A REPORT FROM THE PEW CHARITABLE TRUSTS AND THE INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING4 • The report recommends that the pharmaceutical industry should ° Develop systems to proactively identify and resolve quality issues: n It was apparent from the interviews as well as a review of the 29 product examples that quality remains a pri mary driver behind shortages -- one that the industry must address. n Improvement opportunities should focus on strengthening quality and also development and implementation of sys tems that proactively identify, measure, and monitor risks across the manufacturer's overall supply chain.
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From page 271... ...
These risk evaluations should look beyond a mere understanding of the compliance and specific indi vidual product risks and instead be broadened to include a review across multiple dimensions. For example, ISPE's Drug Shortages Prevention Plan identified the following di mensions that should be reviewed to understand the risk of a potential shortage: corporate culture, quality systems, metrics, business continuity planning, communication with authorities, and building capabilities.
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From page 272... ...
DRUG SHORTAGES AS A MATTER OF NATIONAL SECURITY: IMPROVING THE RESILIENCE OF THE NATION'S HEALTH CARE CRITICAL INFRASTRUCTURE SUMMIT5,6 Regulatory • Develop a list of critical drugs. Use the WHO Model Lists of Es sential Medicines and other existing resources as a starting point to define what a shortage is and develop a list of critical drugs needed for (1)
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From page 273... ...
• Create a multistakeholder advisory panel with FDA to address key issues, such as the possibility of creating a stockpile of critical drugs, the logistics of warehousing such excess pharmaceutical inventory, and where the excess inventory should be stored. • Improve communication with the entire drug supply chain, in cluding health care providers during, or in advance of, a public health emergency or other event that may create a drug shortage.
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From page 274... ...
• Require federal government authorities with jurisdiction over na tional security to conduct an analysis of domestic drug and medical device manufacturing capability and capacity for critical products to assess whether a threat to national security exists. • Require a GAO study to examine all aspects of the drug supply chain to see if there are any new issues exacerbating drug shortages.
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From page 275... ...
• Ensure hospital staff, health care providers, and pharmacies have capacity to manage drug shortages. ° Ensure early notification of predictable medication shortages and medication substitutes so staff can build necessary infor mation into communication efforts.
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