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6 Awareness Measures for Resilient Medical Product Supply Chains
Pages 163-182

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From page 163...
... , analytics (i.e., processes for turning data into information) , and communication (i.e., channels for sharing FIGURE 6-1 Medical product supply chain resilience framework: potential awareness measures.
From page 164...
... It is clear that situational awareness across medical product supply chains is lacking, and that the coronavirus disease 2019 (COVID-19) pandemic response has highlighted the haphazard and inconsistent federal approach used to monitor medical BOX 6-1 Benefits of Information Sharing in Supply Chain Management • Inventory reduction and efficient inventory management • Cost reduction • Increased visibility and significant reduction of uncertainties • Significant reduction or complete elimination of bullwhip effect*
From page 165...
... Consequently, efforts are needed to collect, compile, and disseminate medical product supply chain data from the various stakeholders to increase end-to-end awareness that will facilitate identification and mitigation of risks. Toward this end, the committee identifies upstream transparency efforts as a critical first step to increasing the resilience of medical product supply chains.
From page 166...
... operations … or to the identity [or] confidential statistical data" of any company, unless disclosure of that information is otherwise "authorized by law." Complete Registration and Listing Requirements Some foreign medical product manufacturers fail to register their facilities because they do not ship their products directly to the United States.
From page 167...
... Manufacturing Location Visibility into the locations where medical products and their constituent components are manufactured is essential to assessing supply risks and formulating policies to address them. Critical information includes the manufacturing locations for FDFs, APIs, and major excipients for drugs and the major locations of primary manufacturing and final assembly steps for medical devices that are intended for sale in the United States.
From page 168...
... Risk-Based Site-Selection Model Score Relevant information on drug quality that is included on prescription labeling would enable better decision making on the part of health systems and increase consumer awareness. FDA guidance on package-level standardized numerical identifiers is one step toward implementing mitigation measures to secure drug supply chains (FDA, 2020)
From page 169...
... Within FDA's Office of Pharmaceutical Quality, the Office of Surveillance prioritizes sites for surveillance inspections by entering the names of the facilities selected by the Site Selection Model into the Center for Drug Evaluation and Research's (CDER's) Catalog of Manufacturing Sites, which are sites that are subject to routine inspection,6 thus producing CDER's Site Surveillance Inspection List (CDER, 2018)
From page 170...
... Third parties could develop their own rating scales for risk and quality using the publicly accessible data if manufacturers of medical products were required to disclose their manufacturing locations and FDA shared the riskbased Site Selection Model scores and the Office of Pharmaceutical Quality scores for facilities that manufacture medical products sold in the United States. As called for by other studies, credible ratings of medical product suppliers will help health systems and group purchasing organizations factor supply chain resilience into their purchasing decisions (see Chapter 7)
From page 171...
... Early and accurate communication fosters trust, preempts misinformation, and ensures appropriate expectations with the public and stakeholders. A recent report by the International Society for Pharmaceutical Engineering, Engage with Health Authorities to Mitigate and Prevent Drug Shortages, further describes the pathways for a medical product manufacturer to notify and collaborate with health authorities and other stakeholders in medical product supply chains to minimize the effect of medical product disruptions or shortages (Tolomeo et al., 2020)
From page 172...
... . CURRENT EFFORTS TO INCREASE AWARENESS Recent reports have called for increased awareness of medical product supply chains through an array of recommendations (see Appendix B)
From page 173...
... . USP's 2020 report also explores a range of voluntary and mandatory approaches to increase information sharing across medical product supply chains.
From page 174...
... For instance, manufacturers need greater incentives to engage in more robust quality management systems that extend beyond mere compliance with current good manufacturing practice regulations. To that end, FDA has endorsed the aim of providing more information to purchasers of medical products -- and possibly even consumers -- about manufacturers' quality management systems (FDA Drug Shortages Task Force, 2020)
From page 175...
... . The SCCT was implemented to provide greater visibility into the supply chains for critical medical products through information gleaned from manufacturers, distributors, providers, and federal entities including the Federal Emergency Management Agency (FEMA)
From page 176...
... Notifications must include additional information on the following: • The reason for the discontinuance or interruption; • If an API is a reason or risk factor, the source of the API and al ternative sources; • Whether any associated devices for the preparation or administra tion of the product is a reason for or risk in the disruption; and • The expected duration of the disruption. The Drug Shortage Reporting Section also adds a mandate to the FD&C that manufacturers of critical drugs, APIs, and associated medical devices must develop, maintain, and implement redundancy risk management plans, which are subject to FDA inspection.14 In addition, the CARES 10  Coronavirus Aid, Relief, and Economic Security Act of 2020, 116th Cong., 134 Stat.
From page 177...
... consumers with more visibility into where their medical products are manufactured (CRS, 2020)
From page 178...
... RECOMMENDATIONS Awareness measures to promote transparency, analytics, and communication are the foundation of any serious effort to increase the resilience of medical product supply chains. Although the public and private measures listed above have made progress in collecting and using data to assess the risks of medical product supply chains, gaps still exist, and the potential power of the U.S.
From page 179...
... These data will enable mapping of medical product supply chains, identifying vulnerabilities such as supply concentrations, and assessing what medical products are most at risk. To facilitate use of this sourcing and quality information, the committee proposes the complementary Recommendation 2 (Public Database)
From page 180...
... , in cooperation with other U.S. government agencies, should establish a publicly accessible database containing the supply chain information acquired for medical products.
From page 181...
... c. Coordinate, conduct, and compile research on the resilience of medical product supply chains, including by funding independent research that uses the established database.
From page 182...
... 2021. Building resilient supply chains, revitalizing American manufac turing, and fostering broad-based growth.


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