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. Remote introductory pharmacy practice experiences focused on veterans prescribed chronic opioid therapy, Evaluation of an opioid risk mitigation initiative for veterans undergoing hip or knee arthroplasty at San Francisco Veterans Affairs Heath Care System, In the midst of an opioid epidemic: Pharmacists on the frontline of substance use disorder treatment, Management of type 2 diabetes with oral semaglutide: Practical guidance for pharmacists, To crush or not to crush: A brief review of novel tablets and capsules prepared from nanocrystal and amorphous solid dispersion technologies, ASHP National Surveys of Pharmacy Practice in Hospital Settings, Population Health Management Theme Issues, Practice Advancement Initiative Collection, Transitions of Care/Medication Reconciliation, Emergency Preparedness and Clinician Well-being, Author Instructions for Residents Edition. In the UK, Brexit has been delayed –– yet again. Product Safety Information The lack of a robust domestic manufacturing infrastructure in the United States has resulted in frequent drug shortages of essential medical items and medications during crises. Where a prescriber considers an unlicensed product appropriate for a patient, the prescription must be written accordingly. In addition, the efficiency of creating the national stockpile and manufacturing capacity should be evaluated by assessing the cost-effectiveness for each of the drugs on the critical drug list. Years of shifting pharmaceutical production overseas and a lack of federal planning illustrate a need to reevaluate pharmaceutical manufacturing and its impact on health systems and patients in the United States. These regulations allow FDA to effectively overlook the US drug market, respond to increased demands for certain drugs, identify possible supply chain disruptions, and cooperate with manufacturers within and outside the United States to maintain adequate supply.31. Then we will have a national crisis.". Last modified on Mon 5 Oct 2020 19.26 EDT. With the growing concern over increasing reliance on imported pharmaceutical products, it is important to understand the economic reasons for outsourcing manufacturing overseas. Among those medications on the ASHP drug shortage list, the 199 new drug shortages reported represented 175 unique drugs. Drugs in short supply often include sterile injectables and potentially life-saving oncology (cancer) treatments. ASHP, Drug shortages statistics, 2001-2019, 23 January 2020. Current Shortages: Dec 17, 2020: Cyclopentolate and Phenylephrine Ophthalmic Solution: Resolved Shortages: Oct 17, 2016: Cyclopentolate Hydrochloride Ophthalmic Solution: Current Shortages: Nov 06, 2020: Cyclosporine Capsules: Resolved Shortages: Nov 22, 2019: Cyclosporine Injection: Resolved Shortages: Jan 16, 2020: Cyclosporine Oral Solution: Current Shortages: Nov 02, 2020 The … In times of crisis, such as natural disasters or war, it is possible for supplies of essential medicines to be completely cut off. The Food and Drug Administration isn't even privy to the information and is only alerted to shortages by the drug companies. Drug shortages aren’t unique to the pandemic. For permissions, please e-mail: journals.permissions@oup.com. Impact of COVID-19 on demand for medications. On this page. On March 27, 2020, FDA published an update regarding permanent discontinuance or interruptions in manufacturing under section 506C of the FD&C Act. 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. 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. However, decreased regulation at the point of manufacturing increases the need for regulation and quality oversight to ensure that drug products meet US standards, with the additional risk of shortages when products do not. Through oversight of drug manufacturing and supply, this office would be tasked with identifying and acquiring manufacturing rights for drugs whose APIs were not readily available from existing suppliers, when manufacturing specific APIs would improve other entities’ ability to manufacture a generic medication, or manufacturing the ingredient were necessary for the office to fulfill its duties. Within the first year of this bill’s enactment, the new office would begin the public manufacturing of insulin, naloxone, and at least 3 specific antibiotics. However, the executive order provides only short-term funding, and questions have been raised regarding the cost and ability of the new startup company to deliver on the sole-source, cost-reimbursement contract, thereby threatening the long-term viability of this contract.39 Below, we propose a framework for a comprehensive approach, outlining important short- and long-term considerations for ensuring a stable supply of drugs critical to maintaining the health of the US population. 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. ... 2020… The drug shortage problem in the US isn't new and remain a "perennial problem," the authors wrote. The newly enhanced policy updates the AMA’s approach to mitigating drug shortages, specifically related to manufacturing innovations, global supply chain transparency, and drug maker incentives. A long-term strategy for addressing critical drug shortages involves increasing domestic production capacity. Drug shortages aren’t unique to the pandemic. "What makes the drug shortage such a challenging crisis is that no one organization or agency oversees this situation and responds accordingly, not even the FDA," Stephen W. Schondelmeyer, the director of the PRIME Institute at the University of Minnesota and co-lead report investiagtor, said in a statement. 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. While funding would be required for this office at the taxpayers’ expense, it is likely that the benefits to taxpayers of establishing the office would outweigh the costs, provided some of the reduced prices were passed on to consumers. "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. Current Drug Shortages; Drug Shortages List; Add To Favorites Share.Print; Drug Shortages List.Current Drug Shortage Bulletins. Creating an emergency manufacturing infrastructure that would produce critical drugs only during a shortage could be a much more efficient approach. Drug shortages in the United States routinely force doctors to ration medicine. Dec 28, 2020: Amobarbital Sodium Injection: Dec 18, 2020: Amphetamine Mixed Salts, Immediate-Release Tablets: Dec 10, 2020: Amphotericin B Injection: Dec 16, 2020: Ampicillin Sodium and Sulbactam Sodium Injection: Dec 28, 2020: Amyl Nitrite Inhalation: Dec 14, 2020: Anagrelide Hydrochloride Capsules: Nov 12, 2020: Argatroban Injection: Dec 16, 2020 Given that measures required to increase the competitiveness of US API manufacturing with those of foreign suppliers would require either huge reductions in labor costs or unpalatable government subsidies, alternative methods must be employed to ensure adequate supplies of critical drugs in the short and long term during crises and shortages. 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. The report further warned drug shortages would have a disproportionate effect on low-income Americans. Failure to address even one of these 3 important foci would result in an incomplete response and unnecessary shortages during a crisis. Drug shortage lists are beginning to grow as people stock up on medications during the COVID-19 pandemic and an increase in hospitalizations strains the drug supply.. 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. Both FDA and the American Society for Health-System Pharmacists (ASHP) have reported that many antibiotics and antiviral medications are currently in short supply. Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. 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. 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%). Generic Name. 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. Impact of COVID-19 crisis on medications supply. If a prescription requests a licensed product which is unavailable due to shortage or supply issue, an unlicensed product cannot be dispensed against such a prescription unless the prescriber has specifically ordered this on the prescription. ... We have seen drug shortages in the past, albeit on a smaller scale. 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. 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.