Individually, the proposed bills form a patchwork response to the chronic issues of drug shortages prior to and during the COVID-19 pandemic. The shortages have been tracked in the US since 2001, but in two decades, there's been no significant improvement, according to CIDRAP. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. The pandemic has "jolted the global pharmaceutical market at all levels and production points" and exacerbated a problem that dates back several decades, researchers said. In a discussion paper by the World Bank’s Human Development Network, foreign manufacturing of drug products was noted to provide important economic advantages over domestic production, including lower labor, infrastructure, transportation, and equipment costs.41 Compared with a Western API company’s average index wage (a ratio of the average hourly wage compared to some standard value) of 100, Indian and Chinese index wages are 10 and 8 (ie, labor costs in those countries were one-tenth and one-twelfth as high, respectively). Abbreviation: API, active pharmaceutical ingredient. Impact of COVID-19 crisis on medications supply. The report says shortages have limited 29 of 40 drugs critical for treating Covid-19 patients, including propofol, albuterol, midazolam, hydroxychloroquine, fentanyl, azithromycin and morphine, according to the American Society of Health-System Pharmacists. However, maintaining specialized storage conditions for certain medications and rotating stock could be difficult, as the federal stockpile would not likely be part of the usual supply chain for these drugs. In this model, manufacturers of generic products could be contracted, or government, military, or other production facilities developed, to maintain these domestic manufacturing capabilities, despite manufacturing costs being higher than in foreign countries. Then we will have a national crisis.". Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. Drug Shortage Report for DUAVIVE. With the growing concern over increasing reliance on imported pharmaceutical products, it is important to understand the economic reasons for outsourcing manufacturing overseas. We recommend the development of a stockpile of finished drug products and their APIs for critical drugs. A more sensitive and proactive reporting infrastructure is needed to ensure that potential shortages due to supply chain interruptions (ie, API shortages), manufacturing issues, or increased demand for critical medications are identified earlier. This brief report highlights drug shortages due to the COVID-19 crisis as of April 14, 2020, and provides recommendations for reducing future drug shortages in response to future threats. As the pandemic has progressed, air and ground traffic have been reduced, exports limited, and factories forced to close. Collectively, these bills and executive orders illustrate how drug shortages and reliance on foreign drug manufacturing have caught the attention of the federal government. Institutions with the National Centers of Excellence in Advanced Pharmaceutical Manufacturing designation would help to develop and research advanced pharmaceutical manufacturing, train a workforce specialized in drug manufacturing, and support federal agencies in creating a secure national pharmaceutical stockpile that could rapidly address drug shortages. Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. Despite the lack of high-quality, controlled clinical trials assessing the efficacy of these treatments, WHO identified hydroxychloroquine and chloroquine as promising treatment modalities. For both solutions, it would be necessary to secure a domestic supply of an API to ensure that supply chain disruptions do not affect manufacturing of critical drugs. Another 67 out of 156 critical acute drugs -- including diazepam, phenobarbital, lidocaine and acetaminophen -- are in short supply, the report said. NHS faces drug shortages as Brexit stockpile used in Covid crisis. Thank you for submitting a comment on this article. "Drug shortages can be a matter of life and death, and some shortages mean that a life-saving drug is not available to U.S. patients at any price," the authors wrote. Maia Anderson, Drug shortages updates: 5 things to know, Becker’s Hospital Review, 24 January 2020. Overall, U.S. health systems spend more than $500 million a year on estimated costs related to drug shortages, with approximately $200 million in direct costs and up to … COVID-19 has exposed major issues within the US healthcare system. ET. In the UK, Brexit has been delayed –– yet again. The report further warned drug shortages would have a disproportionate effect on low-income Americans. These subsidies and other incentives, such as tax incentives, may prove unpalatable to US taxpayers, making the widespread continuous domestic production of critical drugs difficult to maintain. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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COVID-related or not, shortages on the rise During the second quarter of 2020, IDC surveyed 532 pharmaceutical stakeholders across the United States, India, the United Kingdom, and Scandinavia, including pharmaceutical companies (49%), health systems and hospitals (24%), manufacturers (12%), and retail pharmacies (10%). Central and Southern California have 0 percent I.C.U. Passage of this bill and creation of a new Office of Drug Manufacturing could reduce the costs of specific API, thereby potentially lowering costs for manufacturers and potentially improving competition and lowering prices for insurers and consumers. Reporting could also be enhanced and made more sensitive by allowing health systems, pharmacies, and patients to report observed shortages at the point of care. Incentivizing domestic production of critical drugs has several benefits, including creating American manufacturing jobs and related tax revenue. The reasons for shortages often vary.   M "This, in turn, will dramatically increase the need for specific COVID-19 treatment drugs, while at the same, COVID-19 is having a major impact on two of the three key drug manufacturing areas of the world, India and Italy," Osterholm added. Impact of COVID-19 on demand for medications. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm, https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019, https://www.fda.gov/drugs/drug-shortages/agency-drug-shortages-task-force, https://www.fda.gov/media/131130/download, https://www.fda.gov/files/drugs/published/Strategic-Plan-for-Preventing-and-Mitigating-Drug-Shortages.pdf, https://dgft.gov.in/sites/default/files/Noti%2050_0.pdf, https://www.fiercepharma.com/manufacturing/amneal-faces-hydroxychloroquine-shortage-after-finland-tightens-production-report, https://ec.europa.eu/commission/presscorner/detail/en/ip_20_622, https://www.consilium.europa.eu/en/press/press-releases/2020/03/16/statement-on-covid-19-economic-policy-response/, https://www.sanofi.com/en/about-us/our-stories/sanofi-s-response-in-the-fight-against-covid-19, https://endpts.com/coronavirus-outbreak-threatens-shortage-of-150-drugs-report/, https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortages-List?page=All&sort=2&loginreturnUrl=SSOCheckOnly, https://www.washingtontimes.com/news/2020/mar/17/china-threatens-restrict-critical-drug-exports-us/, http://english.mofcom.gov.cn/article/newsrelease/press/202003/20200302945491.shtml, https://community.aafa.org/blog/albuterol-inhaler-shortage-due-to-covid-19-could-impact-people-with-asthma, https://www.fda.gov/news-events/press-announcements/, https://dgft.gov.in/sites/default/files/Noti%201%20Final%20Eng_0.pdf, https://www.theguardian.com/world/2020/mar/14/anti-inflammatory-drugs-may-aggravate-coronavirus-infection, https://www.msn.com/en-us/money/markets/pandemic-linked-tylenol-shortages-popping-up-in-some-places/ar-BB12gRaM, https://dgft.gov.in/sites/default/files/Noti%202%20Final_0.pdf, https://newsroom.vizientinc.com/sites/vha.newshq.businesswire.com/files/doc_library/file/COVID-19_impact_on_essential_meds_for_ventilator_use_-_FINAL.pdf, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-further-steps-help-mitigate-supply-interruptions-food-and, https://www.who.int/medicines/services/essmedicines_def/en/, https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-7-2020, https://www.fda.gov/media/136486/download, https://www.fda.gov/media/136537/download, https://www.dea.gov/press-releases/2020/04/07/dea-takes-additional-steps-allow-increased-production-controlled, https://www.fda.gov/media/137031/download, https://www.congress.gov/bill/116th-congress/senate-bill/3162, https://www.congress.gov/bill/116th-congress/senate-bill/3432/text?r=1, https://www.congress.gov/bill/116th-congress/senate-bill/3478/text?r=1, https://www.reuters.com/article/us-health-coronavirus-usa-phlow/trump-administration-awards-contract-to-make-covid-19-drugs-in-u-s-idUSKBN22V0LF, https://www.nbcnews.com/news/us-news/trump-admin-taps-startup-build-nation-s-first-stockpile-key-n1210011, https://www.govtrack.us/congress/bills/browse, http://documents.worldbank.org/curated/en/848191468149087035/pdf/530750WP0APIEx10Box345594B01PUBLIC1.pdf, https://www.ashp.org/~/media/assets/advocacy-issues/docs/Recommendations-Drug-Shortages-as-Matter-of-Natl-Security, https://www.fda.gov/drugs/drug-shortages/how-report-shortage-or-supply-issue, https://www.ashp.org/Drug-Shortages/Current-Shortages, https://www.ashp.org/Drug-Shortages/AHFS-and-ASHPs-Drug-Shortages-Database, https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Shortage-Parameters, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, Monitor foreign API and pharmaceutical products for potency and contaminants, Implement more frequent and systematic monitoring of foreign APIs and pharmaceuticals Ensure foreign products meet US quality and safety standards, Limit and manage the risks of sudden drug shortages caused by unexpected contaminants, Possibility of more frequent shortages Costly Increased monitoring can slow drug product importation Foreign countries may prevent US inspectors, Develop a list of critical drugs, their substitutes, and APIs, Create a national catalog of drugs and APIs needed to maintain health of US population, Identifies a limited list of drugs for which additional measures described below are needed to ensure a constant supply Identifies APIs that are common to critical drugs and their substitutes, Must be continuously reviewed Uncertainty may be present in determining which drugs are considered critical, depending on type of crisis (eg, respiratory illness, gastrointestinal illness, war), Improve monitoring sensitivity and reporting of critical drug shortages, Mandate and incentivize reporting of critical drug shortages by manufacturers Expand reporting of critical drug shortages to include hospitals, pharmacies, suppliers and/or distributors, and patients, Earlier and more complete detection and reporting of potential drug shortages, May provoke hoarding of medications in short supply, further intensifying a shortage, Develop a national stockpile of critical drugs and API, Create a stockpile of critical drugs and APIs, Addresses short-term shortages Advantages vary depending on who administers the stockpile (ie, federal government, states, contracted distributors, or health systems), Drugs must be used to prevent expiration Many drugs have special storage conditions, Encourage/incentivize manufacturers to produce critical drugs domestically, Increase domestic production of critical drugs, Limits reliance on foreign manufacturing Allows for better monitoring for contamination and identification of manufacturing issues May create new sources of jobs and additional tax revenues, Tax breaks or similar financial incentives typically involve increased costs to taxpayers Medication prices would likely increase due to higher labor and other costs, Develop emergency domestic manufacturing capabilities, Allows rapid production of critical drugs in short supply when duration of short supply exceeds stores in national stockpile, Allows for indefinite supply of critical drugs during prolonged or severe shortages May be much less expensive than incentivizing the continuous domestic production of critical drugs, Risk of contracts lapsing or manufacturing plants becoming outdated if long periods of time elapse between crises Vastly different manufacturing approaches may be needed for some drugs, thereby requiring different processes and increasing costs, Evaluate the cost-effectiveness of maintaining the critical drug stockpile and emergency manufacturing, Continually evaluate the processes, costs, and benefits of maintaining specific drugs in the national stockpile and compare with alternative treatments Determine the benefits of new technologies in minimizing costs of a national stockpile, Provides justification for maintaining the critical drug stockpile and emergency manufacturing Identify areas for improving the efficiency and reducing taxpayer burden for maintaining these measures, Copyright © 2021 American Society of Health-System Pharmacists. Coupled with lower energy and water costs, closer proximity to supply chains, and fewer environmental, safety, and product quality regulations, manufacturing costs are dramatically lower in some countries compared with the United States. Both FDA and the American Society for Health-System Pharmacists (ASHP) have reported that many antibiotics and antiviral medications are currently in short supply. In the first quarter of this year, there were 49 new shortages and over 270 active shortages. With the COVID-19 crisis response limiting manufacturing of certain products and foreign countries placing restrictions on exports of essential medications and equipment, the United States experienced more drug shortages in a recent 3-month period than during the 2 preceding years. Creating an emergency manufacturing infrastructure that would produce critical drugs only during a shortage could be a much more efficient approach.   RP 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.. This descriptive review was not funded. But COVID-19 hasn’t helped. This may be accomplished by either incentivizing the domestic production of critical drugs or creating an emergency manufacturing infrastructure that could be activated during drug shortages. Drug shortages aren’t unique to the pandemic. API would likely need to be stockpiled at the federal level to ensure that supplies were adequate and available to emergency manufacturing plants and that costs for maintaining the stockpile were equitably distributed among all taxpayers. The agency acknowledged drug shortages Thursday, but declined to say which ones ... Dec. 26, 2020, 6:29 p.m. Framework for Addressing Critical Drug Shortages, With Potential Advantages and Limitationsa. Among those medications on the ASHP drug shortage list, the 199 new drug shortages reported represented 175 unique drugs. Report ID: 114978: Drug Identification Number: 02432854: Brand name: DUAVIVE: Common or Proper name: ... 2020-05-11: Estimated end date: Unknown: Actual end date: Shortage status: Actual shortage: Updated date: 2020-11-17: Company comments: In recent days, hospitals have begun to report shortages for drugs used to place patients on ventilators and treat pneumonia. For example, Sanofi, who produces two-thirds of World Health Organization (WHO)–designated essential medicines, pledged that its manufacturing plants would operate 7 days a week to attempt to keep pace with increased demand.14 Also, in February 2020 Sanofi announced that it was moving its API manufacturing to Europe, by consolidating 6 manufacturing sites into a single spinoff company, with the goal of shortening the supply chain and enhancing the ability to increase production when needed.15, Because of COVID-19 infections and hospitalizations, demand for a number of medications has increased. Through the proposed Advanced Manufacturing Technologies Program, FDA would be allowed to support new drug manufacturing technologies that prevent or resolve a drug shortage, maintain an adequate supply of critical medications for national emergencies, and promote innovation in drug product design and manufacturing. As the pandemic progressed, increased demand and supply chain disruptions resulted in shortages of crucial sedative, anesthetic, and analgesic medications commonly used in mechanical ventilation for COVID-19 pulmonary complications. The Affordable Drug Manufacturing Act of 2020 (S 3162),35 proposed in the US Senate on January 8, 2020, included establishing an Office of Drug Manufacturing within the Department of Health & Human Services (HHS), with the purpose of identifying and regulating the rising cost of medications. There is a need for the United States to create a list of critical drugs and potential substitutes so that availability and use of these medications and their API can be monitored and stockpiles and emergency manufacturing capabilities developed. While drug shortages had been going down nationally in 2017 and 2018, they began to tick up again in 2019, when there were 166 new shortages for the year and more than 260 active shortages in any quarter. The authors have declared no potential conflicts of interest. The … The FDA Drug Shortages Task Force has identified lower-priced drugs and sterile injectables as being potential targets of drug shortages.7 Recommendations for addressing shortages have included taking steps to increase the understanding of reasons for shortages and contracting practices; developing a system for measuring and rating quality management of pharmaceuticals; and considering new contracting approaches to help ensure reliable supplies.7 Additional FDA recommendations to prevent or mitigate the impact of future drug shortages include extending expiration dates on certain products, expanding review of new drug applications, promoting generic manufacturing, and creating critical drug lists.8 FDA has also recommended action steps that other agencies could take to address drug shortages and quality issues, including providing manufacturing incentives; using FDA-provided data on manufacturing quality when making purchasing decisions; developing redundancy, capability, and capacity in manufacturing; and minimizing the import and sale of goods by unauthorized sources.9 However, despite these recommendations and actions, the first 3 to 4 months of the coronavirus disease 2019 (COVID-19) pandemic resulted in a greater number of shortages in US domestic medications supply than occurred in the previous 2 years. The guideline addresses the importance of early notifications in drug supply disruptions that can negatively affect the US market in the face of a global pandemic. Dec 28, 2020: Alprostadil Urethral Suppositories: Dec 28, 2020: Amiodarone Injection: Dec 28, 2020: Ampicillin Sodium and Sulbactam Sodium Injection: Dec 28, 2020: ... Drug shortages statistics, and best practices, guidelines and publications related to drug shortages Learn More. Testing delays, staff shortages impede distribution of Covid treatment used by Trump Published Thu, Dec 24 2020 10:28 AM EST Updated Thu, Dec 24 2020 … Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. Generic Name. Anticipated start date: Actual start date: 2020-07-07: Estimated end date: Unknown: Actual end date: Shortage status: Actual shortage: Updated date: 2020-07-23: Company comments: Health Canada comments: Contact Address: 1165 CREDITSTONE ROAD VAUGHAN, ONTARIO CANADA L4K 4N7: Company contact information Both FDA and ASHP maintain lists of medications in short supply. Drugs that hit the FDA’s shortage list for the first time in 2020 A USA TODAY analysis found 28 generics in 405 dosages hit the Food and Drug Administration's list of drugs in shortage … Proposed appropriations for this act were $100 million over a 5-year period. In some cases, a drug maker walks away from a product, claiming it is no longer profitable, ... October 24, 2020 at 6:13 pm. On Nov. 17, the American Medical Association (AMA) adopted a However, it would shift some control for maintaining the stockpile from the government agency responsible for maintaining the stockpile to private corporations.   SL Also on April 7, 2020, the Drug Enforcement Administration (DEA) allowed 2020 aggregate production quotas to be increased by 15%.33 These quotas affect production of controlled substances in high demand during the COVID-19 pandemic and intermediates used in their production, such as hydromorphone, ephedrine, and fentanyl. Remdesivir becomes first Covid-19 treatment to receive FDA approval, Coronavirus pandemic could impact cancer rates and care in the future. India has restricted exportation of many of its API that are essential in making medications like metronidazole, clindamycin, and hydroxychloroquine.10 Finland subsequently restricted exports of hydroxychoroquine API.11 The European Union Commission has responded to member states holding exports of essential medicines and creating national stockpiles by asking all members to lift export bans.12 Also, the commission requested that member states increase drug manufacturing and monitor medication supply and demands.13, To ease the expected supply-side shortages, many API manufacturers have ramped up production. A comprehensive approach to addressing drug shortages can lead to an effective and efficient response and help safeguard the nation from future critical drug shortages. 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