drug shortages 2020

University of Illinois at Chicago College of Pharmacy. Product Safety Information The coronavirus pandemic is causing "unacceptable" shortages of US drug supplies in the United States, according to a report from the Center for Infectious Disease Research and … Karen Blum, Drug shortages are inevitable so be prepared, Specialty Pharmacy Continuum, 24 January 2020. Generic Name. 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 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.. The Securing America’s Medicine Act of 2020 (S 3432),36 introduced in the Senate on March 10, 2020, proposed federal support for the development of advanced pharmaceutical manufacturing technologies and the establishment of a program to develop National Centers of Excellence in Advanced Pharmaceutical Manufacturing. State, regional, or health system–controlled stockpiles, with appropriate incentives, would likely improve response time during a crisis but would also likely lead to significant unnecessary duplication of infrastructure and supplies. In response to the growing risk of public health crises resulting from the COVID-19 outbreak, many countries around the world have attempted to secure adequate supplies of essential medications by limiting exports. Of these 175 drugs, 46.3% were on the WHO essential medicines list.29 As a result of these shortages, clinicians may be forced to use suboptimal or more expensive medicines to treat common and/or serious conditions. Ottawa, November 27, 2020. "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. © American Society of Health-System Pharmacists 2020. Some observers have hinted that a pharmaceutical company may be partly to blame for the vincristine shortage, given the company’s … On Nov. 17, the American Medical Association (AMA) adopted a Remdesivir becomes first Covid-19 treatment to receive FDA approval, Coronavirus pandemic could impact cancer rates and care in the future. The report also suggests recommendations for combating drug shortages, including creating a new federal entity to track, analyze, predict, prevent and mitigate drug shortages. ASHP maintains a similar list of drug shortages, typically reported by healthcare practitioners and patients for use by healthcare practitioners.44 This clinician-focused database includes the reason for a shortage (if the manufacturer is willing to disclose it), product availability, estimated resupply dates, safety issues, and alternative agents and management.45 The ASHP database reports more drug shortages than does the FDA database (due to differing criteria for inclusion).46 However, these databases are reactive rather than proactive, either relying on manufacturer self-report or clinician or patient reporting of shortages after supplies have been exhausted. Thank you for submitting a comment on this article. 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. Examples of critical medications in shortage were dexmedetomidine, etomidate, fentanyl, hydromorphone, ketamine, lorazepam, midazolam, morphine, and propofol.1,16 In March 2020, there was a 51% increase in demand for sedatives and anesthetics and a 67% increase in analgesic medication demand.26 Compounding the problem of increased demand, supply chains have also been impacted by manufacturing issues and shipping delays.27,28. Drug shortages aren’t unique to the pandemic. This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present). Updated 12:19 AM ET, Fri October 23, 2020. , Kilber E, Witmer B, Karlage K, Myrdal P. Oxford University Press is a department of the University of Oxford. June 27, 2020, 2:04 PM • 6 min read. Important considerations for storing these medications are rapid availability during times of crisis, a need to ensure sufficient supplies to last until longer-term solutions can be implemented, a need to provide for proper storage conditions, and a need to continuously move and use stockpiles so that they do not expire—all at as low a cost to taxpayers as possible. In contrast, contracting with national distributors to maintain a stockpile would potentially solve storage and expiration issues, as distributors could continuously rotate stock. 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. 28 These medications are those that WHO suggests should be in adequate quantities within a functioning health system at all times. Antibiotics such as vancomycin, cefazolin, and gentamicin and many other intravenous drugs are being used in patients who experience post-COVID-19 pneumonia.16 China supplies 80% of all antibiotics to the US market.17 Despite claims that manufacturing plants in China have been operating normally, the United States has experienced a significant shortage of several of these essential medicines.18 Albuterol (salbutamol) metered dose inhalers are being used to treat hospitalized patients with respiratory problems.19 Although albuterol is manufactured in several countries, including the United States, China, Spain, Mexico, India, and the United Kingdom, the unexpected increased demand has led to shortages.20, Hydroxychloroquine and chloroquine, antimalaria drugs that are also used for lupus and rheumatoid arthritis, showed potentially promising results in treating COVID-19 symptoms in early trials. The coronavirus pandemic is causing "unacceptable" shortages of US drug supplies in the United States, according to a report from the Center for Infectious Disease Research and … Impact of COVID-19 crisis on medications supply. 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. 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.   SL Current Drug Shortages; Drug Shortages List; Add To Favorites Share.Print; Drug Shortages List.Current Drug Shortage Bulletins. Proposed policies and actions to address domestic drug shortages. OTTAWA, ON, the 28 nov. 2020 / CNW / – Drug shortages (within the meaning of Food and Drugs Act) are still a global problem, and the COVID-19 pandemic has increased demand for some drugs, making it more difficult to maintain the drug supply as needed. This article is more than 2 months old. 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. Last modified on Mon 5 Oct 2020 19.26 EDT. Another measure that should be explored is the use of predictive analytics to determine when increased demand for critical drugs might occur due to impending supply chain issues or political crises. 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 … ... 2020… The authors have declared no potential conflicts of interest. 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. COVID-19 has exposed major issues within the US healthcare system. Closed factories, shipping delays or shutdowns and trade limitations or export bans have severely impacted the supply side of the chain, the analysis concluded, while the pandemic has caused a dramatic increase in the global demand for Covid-19 therapies. The awarding of a contract to manufacture certain medications currently in short supply due to the COVID-19 response may provide a test case for the ability to quickly manufacture drugs when shortages in API or finished dosage forms are identified. Available; Additional units released mid-December 2020 Lupron Depot, 3 Months 11.25 mg PDS Kit (NDC 0074-3663-03) On backorder. On May 19, 2020, in an initiative aimed at reducing US dependence on foreign manufacturing, it was announced that HHS, through an executive order from President Trump, had awarded a contract to a new US company to manufacture API and drugs for COVID-19 treatment.38 Under the $354 million (up to a maximum of $812 million) contract, privately held Phlow Corp, in collaboration with Civica Rx, Virginia Commonwealth University, and Ampac Fine Chemicals, would make more than a dozen generic drugs and their ingredients, including medicines for pain management, sedatives for ventilator support, medicines for maintaining blood pressure, and antibiotics.38,39. Nocella 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.. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. (CNN)The coronavirus pandemic is causing "unacceptable" shortages of US drug supplies in the United States, according to a report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Clark 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. 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. The Food and Drug Administration isn't even privy to the information and is only alerted to shortages by the drug companies. 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. 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: Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ... We have seen drug shortages in the past, albeit on a smaller scale. Please check for further notifications by email. 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. Additional units expected to release December 2020 Delay in shipping of the drug: Lupron Depot PED, 1 Month 11.25 mg PDS Kit (NDC 0074-2282-03) Available Central and Southern California have 0 percent I.C.U. 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. Therefore, the Minister of Health, pursuant to subsection 30.1‍(1) Footnote a of the Food and Drugs Act Footnote b, makes the annexed Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply). Link … A comprehensive strategy for monitoring, along with short- and long-term responses to shortages, is needed to minimize the impact of drug shortages. "The urgency with the drug shortage supply issue is related directly to the major increase in COVID-19 cases that we will experience in the coming months," Michael Osterholm, the director of CIDRAP, said in a news release. "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. 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. However, the global pandemic provides an unusual opportunity to identify key problems and develop potential solutions. The report further warned drug shortages would have a disproportionate effect on low-income Americans. Search for other works by this author on: James Chien-min Ning, BS (PharmD student), Department of Pharmacy Systems, Outcomes and Policy, University of Illinois, Address correspondence to Dr. Touchette (, Current and resolved drug shortages and discontinuations reported to FDA, The drug shortage crisis in the United States: causes, impact, and management strategies, Congressional testimony: safeguarding pharmaceutical supply chains in a global economy, Collaborative management strategies for drug shortages in neurocritical care, When pigs fly: a multidisciplinary approach to navigating a critical heparin shortage, Imminent risk of a global shortage of heparin caused by the African Swine Fever afflicting the Chinese pig herd, Drug shortages: root causes and potential solutions, Strategic plan for preventing and mitigating drug shortages, Government of India Ministry of Commerce & Industry, Amendment in export policy of APIs and formulations made from these APIs, Amneal faces hydroxychloroquine API shortage after Finland tightens production: report, Coronavirus: Commission calls on member states to optimise supply and availability of medicines, Statement on COVID-19 economic policy response, Sanofi’s response in the fight against COVID-19, Sanofi outlines big API plans as coronavirus outbreak reportedly threatens shortage of 150 drugs, American Society of Health-System Pharmacists, ‘Wake-up call’: Chinese control of U.S. pharmaceutical supplies sparks growing concern, Ministry of Commerce of the People’s Republic of China, Online regular press conference of the Ministry of Commerce (March 12, 2020), Albuterol inhaler shortage due to COVID-19 could impact people with asthma, A comparison of pharmaceutical product performance of albuterol inhalers available in the United States and those obtained in a Mexican border town, Coronavirus (COVID-19) update: daily roundup March 30, 2020, coronavirus-covid-19-update-daily-roundup-march-30-2020, Amendment in export policy of hydroxychoroquine, Anti-inflammatories may aggravate Covid-19, France advises, Pandemic-Linked Tylenol Shortages Popping Up in Some Places, COVID-19 impact on drugs essential for ventilator use, Coronavirus (COVID-19) update: FDA takes further steps to help mitigate supply interruptions of food and medical Products, World Health Organization Model List of Essential Medicines, Coronavirus (COVID-19) update: daily roundup April 7, 2020, Notifying FDA of a permanent discontinuance or interruption in manufacturing under section 506C of the FD&C Act: guidance for industry, fact sheet for health care providers: emergency use authorization (EUA) of hydroxychloroquine sulfate supplied from the Strategic National Stockpile for treatment of Covid-19 in certain hospitalized patients, DEA takes additional steps to allow increased production of controlled substances used in COVID-19 care, Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency: guidance for industry, Affordable Drug Manufacturing Act of 2020, S 3162, 116th Cong, 2nd Sess (2020), Securing America’s Medicine Cabinet Act of 2020, S 3423, 116th Cong, 2nd Sess (2020), Commission on America’s Medical Security Act, S 3478, 116th Cong, 2nd Sess (2020), Trump administration signs up new company to make COVID-19 drugs in U.S, Trump admin taps startup to build nation’s first stockpile of key drug ingredients, Exploratory study on active pharmaceutical ingredient manufacturing for essential medicine, Drug shortages as a matter of national security: improving the resilience of the nation’s healthcare critical infrastructure; recommendations from September 20, 2018 summit, American Society of Health- System Pharmacists. As of April 7, 2020, FDA had approved an abbreviated new drug application for hydroxychloroquine sulfate, an action that supports increased production of hydroxychloroquine and chloroquine in response to supply chain disruptions and increased demands.30,31 FDA also granted hydroxychloroquine and chloroquine emergency use authorization, restricting access to specific FDA-approved indications and COVID-19 treatment.32 Furthermore, hydroxychloroquine has been listed as a national emergency stockpile medication, leading Sandoz and Bayer Pharmaceuticals to donate supplies of these medications to a national stockpile. Creating an emergency manufacturing infrastructure that would produce critical drugs only during a shortage could be a much more efficient approach. But COVID-19 hasn’t helped. There's been more than 250 drug shortages over the past few years, the study said, "many for critical medications, including both acute drugs for treating emergency situations and chronic drugs for managing serious long-term conditions.". Revision Date. 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. Adding to the stress on medication supplies, the Indian government blocked the export of hydroxychloroquine and its formulations on April 4, 2020.22. Collectively, these bills and executive orders illustrate how drug shortages and reliance on foreign drug manufacturing have caught the attention of the federal government. NHS faces drug shortages as Brexit stockpile used in Covid crisis. These emergency manufacturing infrastructure that would produce critical drugs has several benefits, including creating American jobs! 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