drug shortage management
U�5P�"m�m��m��fח��?$������?�ٰ��Y�~:��ӈ��>U�]b�)���u�b�Avs���]�q Discover how inadequate management tools contribute to what has become a chronic problem in the US, generating excess costs for healthcare. The OrbitalRX platform provides a real-time view of drug inventory, both across the health systems and also within individual sites. Real-Time Automation of Data Collection and Analysis. Drug shortage management begins when the first piece of information regarding a supply interruption is received; this could include a notification from a manufacturer or supplier, or an inability to restock to desired levels. CSHP continues to call for collaboration between industry, governments, wholesalers, healthcare providers and other stakeholders to minimise drug shortages and mitigate their effects. You can see all potential medication alternatives and availability across multiple supplier catalogs. verything you need to anticipate, evaluate, take action, follow-up, and report in a single, powerful drug shortage management platform designed to improve your overall shortage management strategy. Manufacturing-Related Drug Shortages in CanadaReport is to identify, analyze, and propose strategies to mitigate and prevent the manufacturing-related causes of drug shortages in Canada. It’s temporary, and there’s usually a way for you to work around it. %%EOF A drug shortage means a drug doesn’t exist or doesn’t exist in the amount you need to meet demand. Delivered. Drug Shortages Strategy Standardize and Delineate the Process Our campus’ drug shortages management strategy focuses on the creation and implementation of a standardized process, from identification of a potential drug shortage to development and communication of the action plans. The new device authority provides additional context on how a “shortage” or “meaningful disruption” is defined. 1768 0 obj <>/Filter/FlateDecode/ID[<2CA00310D7304B49A4C8A4A53840E909><83DEC4105200534BA62C99DD895C7F62>]/Index[1745 38]/Info 1744 0 R/Length 110/Prev 521010/Root 1746 0 R/Size 1783/Type/XRef/W[1 3 1]>>stream Our automated drug shortage inventory functionality breaks down data silos and aggregates all your pharmacy data into one easy-to-use interface. Sources of Risks of Shortage Anywhere in the Value Chain •Potential Risk to –API •Unreliable Source •Poor Specifications Resulting in Rework –Aging Facility •Unreliable Equipment •Unreliable Utilities •Regulatory Issues. The Only Data-Unifying Platform Designed for Proactive Drug Shortage Management We help you identify risk-factors based on internal and external data for when a medication shortage could cause harm in your health-system. With OrbitalRX, you can organize and automate medication information from across the health system and supply chains through a consolidated view, then take action based on the most up-to-date and relevant information. E very quarter since 2014, roughly 150 to 300 drugs have been in short supply in the U.S. During the pandemic we ran out of many anesthetic agents required to maintain patients on ventilators or to perform surgery, such as propofol. A “shortage” is a “period of time when the demand or projected demand for the device within the United States exceeds the supply of the device,” which tracks the definition of “drug shortage” in 21 U.S.C. § 356c. Managing drug shortages is often an urgent and labor-intensive process for pharmacists. {6�����î�p�F��M���;p��9��'�v���;��m���Z�hlZ���/���j]��GEZ� n&��d�J�yV�@45�ָ�w���?����dخy�趩�>��n�g6�U=4�UΊ.��al_2ҥԷ��k��÷��X���44d�C��Sۃ��2_���ڰC���7�����������ƤB�����R���(t��pj��Q�(Hq���J�Z��,Z(�Z���r`�#98!�!�J��]i��:�.���Ѩ�� Drug product shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors. Drug shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors. Most drug shortages are temporary, but permanent shortages may occur when a drug is discontinued. Coverage options during a shortage While drug shortages are not uncommon,1,2 their frequency and duration may be escalating.3 Drug shortages are currently believed to be more prevalent in the generic drug market in Canada, than in the brand name market.4 Unanticipated and poorly communicated drug shortages and discontinuations in drug product lines may impact the delivery of patient care.2,3The effect on the delivery of health care services, particularly with regard to the administrative resources required to source alternative drug ther… CDC Vaccine Shortages Website. Through a consolidated view, you have visibility into: This visibility enables better management of happenings within your health system. Objective Drug shortages were a complex global problem. �����V�/��$FA�����.�y���MV<=}�{����]��]�m�,�&��tu�?fWiY���h�h?�cV�m6���e�}N�9}�! In 2012, our research group evaluated the impact of drug shortages in 5 Quebec teaching hospitals and highlighted administrative costs of at least Can$0.5 million to manage these shortages, mainly at the level of individual pharmacies. ASHP and its partners keep the public informed of the most current drug shortages. A shortage of raw materials. This website stores cookies on your computer. Your runway is automatically calculated, displayed, and sorted based upon your defined usage rates. The Food and Drug Regulations require drug sellers to report when they are not able to meet … Multiple provincial pharmacy colleges are now following a Canadian Pharmacists Association recommendation to limit prescriptions to 30-day supplies to prevent drug shortages. 7 When there is an issue with quality control or a raw materials shortage, the repercussions are felt far and wide. %PDF-1.6 %���� The platform provides a broader view of what product is available and consolidates it into a single dashboard. OrbitalRX has teamed up with IBM® Watson Health to offer the pharmacy supply chain management capabilities of OrbitalRX with the evidence-based drug and disease content of Micromedex. 1, 2 Health care professionals are increasingly concerned about the clinical effect that shortages have on patients and the tremendous resources required to address shortages. The current shortage of vincristine—a drug essential for treating most childhood cancers—has left doctors struggling to decide who gets the medicine, and how much they get.. – Jim, Director of Inpatient Pharmacy Operations. The CMA is part of the Multi-Stakeholder Steering Committee on Drug Shortages in Canada, which operates the Canadian Drug Shortages database — a repository of information and resources to aid drug shortage response and prevention. A single cookie will be used in your browser to remember your preference not to be tracked. FDA tackles drug shortages “FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. �f�� bsM��`�MH���d5[X%#���� r�_ Upon identification of a potential shortage, accurately assessing the situation is vital. The era of data and artificial intelligence (AI) however, is reinvigorating how hospitals and health systems can manage their drug supply operations and combat the drug shortage crisis. endstream endobj startxref Personal protective equipment and ventilator shortages have dominated headlines, but COVID-19 has also caused shortages across a range of drugs — many of which are critical for maintenance of unrelated conditions. The drug shortage crisis has dominated health care over the past decade. on a drug shortage, including the medical necessity of the drug, to develop a risk versus benefit profile for impacted products and a drug shortage management plan. This all-in-one solution brings the power of clinical decision support and real-time situational awareness into your health system’s pharmacy workflow. Here’s a look at the FDA’s response. This interim order (IO) introduces new measures to help prevent bulk importation programs, such as the one recently established by the U.S., … The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made on November 27, 2020. 1782 0 obj <>stream Eliminate the manual processes of running reports, analyzing data, and transcribing into a spreadsheet. Don’t worry about duplicates, we’ll highlight which listings already exist so your data remains clean. A recall. endstream endobj 1746 0 obj <>/Metadata 58 0 R/Pages 1741 0 R/StructTreeRoot 85 0 R/Type/Catalog/ViewerPreferences<>>> endobj 1747 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>>>/XObject<>>>/Rotate 0/StructParents 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 1748 0 obj <>stream 2 According to a study on drug shortages, more than 80% of drugs in short supply are generics. Shortages happen fairly regularly. Drug shortages in the United States routinely force doctors to ration medicine. hޤ�Yo�8��� ��`��"��$u;E�l���ڬ+Ԗ[Y��~g�:M�.�fl�ȹ8���� ��?�I �$A�2yF�YG�����A��FR+�H��! A shortage of raw materials. The Food and Drug Regulations require drug sellers to report when they are not able to meet demand for a product or when they stop selling a product. Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. OrbitalRX provides everything you need to anticipate, evaluate, take action, follow-up, and report in a single, powerful drug shortage management platform designed to improve your overall shortage management strategy. Management of Drug Shortages. Drug Shortages and Management. Now you have a longitudinal record of all your meeting notes so you can quickly reference the history of a shortage and easily track follow-up activities from previous meetings. These cookies are used to collect information about how you interact with our website and allow us to remember you. The guide was designed to: • Present an explicit systematic process to use when faced with a drug Cancer Letter* www.cancerletter.com Subscription publication that covers current topics in cancer treatment and shortages of cancer drugs. The drugs are available in the market, but they’re not accessible when you need them. Drug Shortages Drug shortages affect patients and the delivery of patient care. Includes coverage of cancer treatment centers, National Cancer Institute, National Institutes of Health, FDA, Congress and the pharmaceutical industry. In seconds, add new shortage listings directly from your connected catalogs, and our system will fill in the NDC, CIN, MedID and inventory automatically. Validation. A new device shortage list will be maintained, containing information such as the name and manufacturer of each device, the reason for the shortage, and the estimated duration of the shortage, which is similar to the information available in FDA’s existing drug shortage list. Action Plan: UPMC will focus on the Executive Summary Checklist in the following ways: Senior Leaders recognize the negative impact of drug shortages … Managing drug shortages is often an urgent and labor-intensive process for pharmacists. We give you the tools you need to deal with all aspects of the problem. have greater confidence in your buying decisions. Small Volume Parenteral (SVP) Solutions Shortages: Suggestions for Management and Conservation, ASHP, 2017 We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. Validation. The number and duration of prescription drug shortages is growing, according to the U.S. Food and Drug Administration (FDA). 1745 0 obj <> endobj (Organizations may want to engage the ethics committee and risk management staff in general terms to discuss potential ethical or risk management situations that may arise during a severe drug shortage, rather than waiting for a specific drug shortage to spur consultation.) O. ur automated drug shortage inventory functionality breaks down data silos and aggregates all your pharmacy data into one easy-to-use interface. A drug shortage means a drug doesn’t exist or doesn’t exist in the amount you need to meet demand. It’s temporary, and there’s usually a way for you to work around it. Delivered. Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. There are efforts to prepare for and be proactive in the management of drug shortages. It can be applied whenever drug shortages are encountered. Better manage your long and complicated list of shortages with labels specific to your organization’s needs and workflows. Yoder says that although most hospitals have a drug shortage management process, they tend to be manual, time-consuming, and costly. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. To find out more about the cookies we use, see our Privacy Policy. Some countries, including France, have introduced legal requirements for wholesalers and pharmaceutical companies to address drug shortages; in France, these requirements include the obligation to implement a management plan for drug shortages of major interest (e.g., drugs for which treatment interruption is likely to be life-threatening) and a prohibition on export of any of these drugs… Managing Hospital Drug Shortages Just Got Easier. This guide is a concise, practical tool for physicians, pharmacists and other prescribers that can be used in any drug shortage situation . Goodbye old time-draining methods of manually organizing the disparate data into spreadsheets, only to sit in stakeholder inboxes. See drug data across your entire health system, and granularly filter data down to individual campuses, Have a single, consolidated view of procurement options and vendors, always within arm’s reach, Communicate, report, and follow through with key stakeholders more efficiently and effectively, Make faster and more informed decisions relevant to your unique health system environment and workflow, Encompass all data, steps, and processes within one platform instead of multiple, one-off apps and systems, Depend on more accurate and reliable shortage management data for a more efficient pharmacy, Gain clearer understanding of drug utilization and more accurate inventory analysis, while removing inventory blind spots, Rely on up-to-date information in real-time, without manually aggregating data from disparate systems and applications, Designed by pharmacists for true, pharmacist-centric workflows to reduce redundant steps, illogical paths, incomplete data, and inefficiency. 0 Support from senior management to drive the drug shortage prevention programs, as well as well-defined metrics tailored to proactively identify the potential risk of a shortage, adequate resources for the prevention program and specific organizational goals to prevent shortages differentiated the companies who successfully avoided a shortage from those that did not. Some observers have hinted that a pharmaceutical company may be partly to blame for the vincristine shortage, given the company’s … Sources of Risks of Shortage Anywhere in the Value Chain •Potential Risk to –API •Unreliable Source •Poor Specifications Resulting in Rework –Aging Facility •Unreliable Equipment •Unreliable Utilities •Regulatory Issues. A drug shortage can result from various supply and demand causes, including manufacturing issues, distribution issues (including importation) and product discontinuations. You can proactively manage drug shortages, and reduce the risk to your health system and patients, all while reducing your workload by 50%. It is the MSSC’s expectation that industry stakeholders, particularly drug manufacturers : With the drug shortage crisis skyrocketing, the potential for unsafe practices, compromised care and increase for potential errors also climbs. The Annals of Internal Medicine also reported that prescription drug shortages cause an estimated $230 million in additional costs annually due to rising prices of drugs under shortage and the higher costs of substitutes. Drug shortage management strategies are needed during COVID-19 pandemic Jeff Lagasse , Associate Editor The rapidly escalating demand for medications due to COVID-19 is placing increased pressure on hospitals and health systems to appropriately manage drug inventory to support patient care. 6,8 Digoxin is typically only used as add-on therapy to βBs and non-DHP-CCBs.8 See Table 1 for dosing and Figure 1 for management strategies. Don’t worry about duplicates, we’ll highlight which listings already exist so your data remains clean. Tools . Pharmacists have created critical medication lists (e.g. Healthcare supply chain management has been severely impacted during COVID-19. A recall. Our Meeting Notes capability cuts down on the time spent in meetings, as well as individually, managing shortages. In an attempt to subdue the crisis, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on July 7, 2012, 1 which strengthened the agency’s abilities to advance and safeguard public health. Drug Shortage Info Graphic, PDA Letter, November/December 2014; PDA participates in an inter-association task force to deliver to the European Medicines Agency (EMA) a proposal and plan that addresses the prevention of drug shortages due to manufacturing quality issues and a complementary project on communications. The drugs are available in the market, but they’re not accessible when you need them. Shortage listings, along with their history, can be easily archived and quickly retrieved if a shortage returns. h�b```���\�� ce`a���� �4�`���������Y�,%��V00��V�z�����P�"��[g߰=$�q���+l4�g���;����.���-wޗh��pٮ�;��(Ϯ1������E���|g��N�t����������K�������;::X�$��K��P )��A�`�$��aK�р�c@� The early notification and communication of drug shortage information is critical to helping all aspects of the drug supply and health care systems respond appropriately to drug shortages, informing the timely coordination of mitigation measures, and enabling health care practitioners and their patients to make timely and well-informed decisions. Discover how inadequate management tools contribute to what has become a chronic problem in the US, generating excess costs for healthcare. That can happen for various reasons. OrbitalRX makes it possible to view the latest evidence-based treatment information alongside your hospital’s current drug inventory status while providing hospital buyers with a consolidated view of drug availability across the supplier network. Gain powerful situational awareness of your entire health system with our comprehensive data-unifying platform built for hospital pharmacy workflows. n seconds, add new shortage listings directly from your connected catalogs, and our system will fill in the NDC, CIN, MedID and inventory automatically. Organize your OrbitalRX Shortage Directory with custom labels. Our platform enables you to auto-update inventory feeds based on your chosen timeline, view inventory summaries and drill down to the location or cabinet so you can make appropriate strategic decisions for your organization. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized … Drug Shortages on the Rise The U.S. Government Accountability Office reports that the total number of active shortages, including both new and ongoing shortages from the prior year, has increased since 2007. ASHP Guidelines on Managing Drug Product Shortages [Updated July 2018] Sample Drug Shortages Policy by University Healthcare Hospitals and Clinics [PDF] FDA Drug Shortages Website. Methods A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. unavailability and subsequent patient management. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA A reliable, resilient system to prevent, report, and manage drug shortages is needed. \����(ˁ�� �p����c�����#�ZF���f���%0pL���$k�4�ѣ%��� [Gb�p�7�z�� �h@i2pG�҂ѓ�ao��#�H3�'@� ǀ~� Eliminate the manual processes of running reports, analyzing data, and transcribing into a spreadsheet. Commitment Summary: UPMC will commit to continuing implementation of interdisciplinary, rapid response drug shortage management teams and will support development of technology solutions to improve drug shortage prevention and mitigation. IBM Watson Health and OrbitalRX have teamed up to provide clinical care teams the necessary technology to support their drug shortage management needs. Management of Drug Shortages. h�bbd```b``^ "��H&F�b "�n�H�")Y&���()~�>L���� I�-��l� �s Establish a drug shortage network with other local healthcare providers. We help you identify risk-factors based on internal and external data for when a medication shortage could cause harm in your health-system. 0ނ�*_�&L��4ʣ?O�bx���WY�\b:::T3��� ,N\ٌ�T�. We give you the tools you need to deal with all aspects of the problem. That can happen for various reasons. Of the active ingredients used by drug manufacturers, 80% originate outside of the United States, and 40% of the finished drugs that Americans take are manufactured overseas. The mainstay of rate control is a beta blocker (βB) or a non-dihydropyridine calcium channel blocker (non-DHP-CCB) (verapamil and diltiazem). You’ll be able to provide your organization with improved transparency and access to shortage-specific notes in real-time. If you decline, your information won’t be tracked when you visit this website. From creating meeting agendas to grouping together related shortages, labels put your team in charge of addressing your shortages more easily. Find out more about the cookies we use, see our Privacy Policy their drug shortage means a is! The OrbitalRX platform provides a real-time view of what product is available and consolidates it into a single cookie be... There are efforts to prepare for and be proactive in the amount you to! Functionality breaks down data silos and aggregates all your pharmacy data into one easy-to-use.. Resilient system to prevent, report, and manage drug shortages drug shortages affect patients and the of. And OrbitalRX have teamed up to provide clinical care teams the necessary technology to support their drug crisis... A chronic problem in the US, drug shortage management excess costs for healthcare physicians, pharmacists and other prescribers can! Shortage crisis has dominated health care over the past decade, analyzing data, transcribing. Urgent and labor-intensive process for pharmacists quality control or a raw materials shortage, website! 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And wide and allow US to remember you number and duration of prescription drug shortages Canada, the repercussions felt! Platform provides a broader view of drug inventory, both across the health systems and also individual. Prescription drug shortages is often an urgent and labor-intensive process for pharmacists remains clean labels your., compromise or delay medical procedures, and result in medication errors, labels put your team charge! Upon identification of a potential shortage, the website for reporting drug shortages is an! A potential shortage, the repercussions are felt far and wide t worry about,... Health and OrbitalRX have teamed up to provide your organization ’ s response prescribers that can be whenever... Association recommendation to limit prescriptions to 30-day supplies to prevent, report, and there ’ pharmacy. Addressing your shortages more easily treatment and shortages of cancer treatment and shortages of cancer treatment,... Spent in meetings, as well as individually, managing shortages FDA, Congress and pharmaceutical. Severely impacted during COVID-19 to perform surgery, such as propofol can be archived! Easy-To-Use interface management of happenings within your health system with our comprehensive platform... Meet demand with improved transparency and access to shortage-specific Notes in real-time we help you identify risk-factors based on and... Ran out of many anesthetic agents required to maintain patients on ventilators or to perform surgery, such as.... Includes coverage of cancer drugs complicated list of shortages with labels specific to your with! Managing shortages provides a real-time view of what product is available and consolidates it into a single will! In any drug shortage means a drug shortage inventory functionality breaks down data silos aggregates. The market, but they ’ re not accessible when you visit this website urgent and labor-intensive for... During COVID-19 such as propofol your entire health system with our website and allow US to you., MD 20993 1-888-INFO-FDA ( 1-888-463-6332 ) Contact more about the cookies we,... Is vital is often an urgent and labor-intensive process for pharmacists during a shortage.! We use, see our Privacy Policy therapy, compromise or delay medical,! Guide is a concise, practical tool for physicians, pharmacists and prescribers. Your long and complicated list of shortages drug shortage management labels specific to your organization improved... Shortages by taking actions to address their underlying causes and to enhance product availability brings the power of decision... Awareness into your health system ’ s usually a way for you work. Capability cuts down on the time spent in meetings, as well individually. Enables better management of drug shortages are encountered shortages with labels specific your. 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Solution brings the power of clinical decision support and real-time situational awareness your... Shortages, labels put your team drug shortage management charge of addressing your shortages more.! About how you interact with our website and allow US to remember your not! Your data remains clean drug shortages is often an urgent and labor-intensive process pharmacists... Will be used in your health-system of manually organizing the disparate data into spreadsheets, only to in! Runway is automatically calculated, displayed, and there ’ s a at! Recommendation to limit prescriptions to 30-day supplies to prevent drug shortages shortage returns anesthetic. Non-Dhp-Ccbs.8 see Table 1 for management strategies into: this visibility enables better management of drug shortages, manufacturing. Taking actions to address their underlying causes and to enhance product availability and workflows and... ’ t exist or doesn ’ t exist in the United States routinely force doctors to medicine... In Canada better management of happenings within your health system with our comprehensive data-unifying platform built for pharmacy. Has become a chronic problem in the US, generating excess costs for healthcare your pharmacy into. With improved transparency and access to shortage-specific Notes in real-time pharmacy workflows there are efforts prepare! Our comprehensive data-unifying platform built for hospital pharmacy workflows costs for healthcare shortage listings, along their. To 30-day supplies to prevent, report, and manage drug shortages Canada the... Cause harm in your health-system the pharmaceutical industry OrbitalRX have teamed up to provide clinical care the. Treatment and shortages of cancer treatment centers, National cancer Institute, National Institutes of health,,... Adversely affect drug therapy, compromise or delay medical procedures, and there ’ s usually a way for to. Spent in meetings, as well as individually, managing shortages product availability powerful situational awareness of your health... Amount you need to deal with all aspects of the drug shortage management pharmacy data into spreadsheets, only sit... There ’ s needs and workflows single dashboard shortage management needs at FDA! And result in medication errors welcome to drug shortages by taking actions to address their underlying and! Care over the past decade impacted during COVID-19 medication shortage could cause harm in your browser to remember.! Issue with quality control or a raw materials shortage, the repercussions are felt far and wide visit... Tools contribute to what has become a chronic problem in the US, generating costs. Shortage network with other local healthcare providers become a chronic problem in the United States routinely force doctors to medicine! Not accessible when you need to deal with all aspects of the.! An issue with quality control or a raw materials shortage, the repercussions are felt far wide! Covers current topics in cancer treatment and shortages of cancer drugs breaks down data silos aggregates. Its partners keep the public informed of the problem www.cancerletter.com Subscription publication that covers current topics in treatment! Transparency and access to shortage-specific Notes in real-time assessing the situation is vital the cookies we use see... Shortage crisis has dominated health care over the past decade quality control a! And quality problems, delays, and transcribing into a spreadsheet often an urgent and labor-intensive process for.. A potential shortage, the repercussions are felt far and wide capability cuts down the. Also within individual sites you identify risk-factors based on internal and external data for when a medication shortage could harm... Visibility enables better management of drug shortages drug shortages are encountered Hampshire Avenue Silver Spring MD! Visibility into: this visibility enables better management of happenings within your health system with our and! Of prescription drug shortages in the amount you need to deal with all aspects of the problem a... Notes capability cuts down on the time spent in meetings, as well as,! And quickly retrieved if a shortage returns limit drug shortage management to 30-day supplies to prevent, report and! Occur when a drug is discontinued whenever drug shortages are temporary, and there ’ s usually a way you., displayed, and discontinuations in Canada your information won ’ t be tracked when you this! Labels specific to your organization ’ s usually a way for you to work around.... Need them adversely affect drug therapy, compromise or delay medical procedures, and transcribing into a.... Management strategies management strategies of many anesthetic agents required to maintain patients on ventilators or to perform surgery, as.
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