2020 May 12;7:157. doi: 10.3389/fmed.2020.00157. Orthopedics. [8], Asceniv solution for injection, ADMA Biologics, Immune globulin (human) - slra 10%, 5 gram protein/50 mL single dose vial, (available through Biocare SD) NDC 69800-0250-02, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 1 gram protein/6 mL single dose vial, NDC 68982-0810-01, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 1.65 gram protein/10 mL single dose vial, NDC 68982-0810-02, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 2 gram protein/12 mL single dose vial, NDC 68982-0810-03, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 3.3 gram protein/20 mL single dose vial, NDC 68982-0810-04, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 4 gram protein/24 mL single dose vial, NDC 68982-0810-05, Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 8 gram protein/48 mL single dose vial, NDC 68982-0810-06, Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 1 gram protein/5 mL vial, NDC 00944-2850-01, Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 2 grams protein/10 mL vial, NDC 00944-2850-03, Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 4 grams protein/20 mL vial, NDC 00944-2850-05, Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 8 grams protein/40 mL vial, NDC 00944-2850-07, HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 10 grams protein / 100 mL - 800 units / 5 mL dual vial, NDC 00944-2512-02, HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 2.5 grams protein / 25 mL - 200 units / 1.25 mL dual vial, NDC 00944-2510-02, HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 20 grams protein / 200 mL - 1600 units / 10 mL dual vial, NDC 00944-2513-02, HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 30 grams protein / 300 mL - 2400 units / 15 mL dual vial, NDC 00944-2514-02, HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 5 grams protein / 50 mL - 400 units / 2.5 mL dual vial, NDC 00944-2511-02, Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 100 mL / 10 gram protein bottle, NDC 68982-0850-03, Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 20 mL / 2 gram protein bottle, NDC 68982-0850-01, Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 200 mL / 20 gram protein bottle, NDC 68982-0850-04, Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 50 mL / 5 gram protein bottle, NDC 68982-0850-02, Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 100 mL / 5 gram protein bottle, NDC 68982-0840-03, Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 20 mL / 1 gram protein bottle, NDC 68982-0840-01, Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 200 mL / 10 gram protein bottle, NDC 68982-0840-04, Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 50 mL / 2.5 gram protein bottle, NDC 68982-0840-02, Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 500 mL / 25 gram protein bottle, NDC 68982-0840-05, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 10 mL / 1 gram protein bottle, NDC 00069-1011-02, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 100 mL / 10 gram protein bottle, NDC 00069-1312-02, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 200 mL / 20 gram protein bottle, NDC 00069-1415-02, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 25 mL / 2.5 gram protein bottle, NDC 00069-1109-02, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 300 mL / 30 gram protein bottle, NDC 00069-1558-02, Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 50 mL / 5 gram protein bottle, NDC 00069-1224-02, ADMA Biologics has Bivigam 10% on allocation through Biocare SD. Considering that previous Ig shortages, such as the ones in the late 1990s, had created similar predicaments, one would have expected hospitals and other centralized care systems to be thoughtful stewards of such a precious resource. Burry LD, Barletta JF, Williamson D, Kanji S, Maves RC, Dichter J, Christian MD, Geiling J, Erstad BL. There is … Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Drug product shortages can adversely affect drug therapy, compromise or delay medical procedures, result in medication errors, and cause patient harm.1–38 In addition to these potential problems, healthcare professionals are also increasingly concerned about the tremendous resources required to address shortages, estimated at $209 million in 2013 for the purchase of more-expensive substitutes alone, which excludes other significant costs (e.g., drugs purchased “off contract,” therapeutic alternativ… Mallhi TH, Liaqat A, Abid A, Khan YH, Alotaibi NH, Alzarea AI, Tanveer N, Khan TM. 70(9): 751-752. « Back to Drug Shortage Product Bulletins. The ASHP Board of Directors Donald E. Francke Medal, which is awarded to a pharmacist who has made international contributions to the advancement of pharmacy practice, was awarded to Anthony Serracino-Inglott, PharmD. Data are available regarding dosing using ideal or adjusted body weight.[10-12]. [3], Grifols has Gamunex-C and Flebogamma available and distributors are allocating product. FDA is responsible for assisting with drug product shortages … Generic Name Shortage Status Revision Date; 0.45% Sodium Chloride Injection Bags: Resolved Shortages: May 26, 2016: 0.9% Sodium Chloride 10 mL, 20 … 2015. * Ensure the dose and interval are appropriate. However, according to both organizations, there’s more work to be done. [4], Grifols has Xembify 20% solution available and distributors are allocating product. [8], Immune globulin products are life-saving and critical products for a number of acute and chronic conditions including, but not limited to: B-cell chronic lymphocytic leukemia, chronic inflammatory demyelinating polyneuropathy, idiopathic thrombocytopenic purpura, Kawasaki disease, and primary immunodeficiency diseases.[9]. Miljković N, Godman B, van Overbeeke E, Kovačević M, Tsiakitzis K, Apatsidou A, Nikopoulou A, Yubero CG, Portillo Horcajada L, Stemer G, Kuruc-Poje D, De Rijdt T, Bochenek T, Huys I, Miljković B. Product switches may be inevitable during times of shortage. This site needs JavaScript to work properly. "Our community needs it for antibody replacement. 2020 Jul;27(4):202-208. doi: 10.1136/ejhpharm-2020-002341.  |  Epub 2020 Aug 14. This report summarizes the presentations, discussion, and … May 9, July 11, September 24, November 20, 2019; January 29, April 6, August 28, and November 6, 2020. Check out coverage of special events, educational sessions, awards, and more in News & Views, Midyear’s daily news publication. August 28, 2020. Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information. Serracino-Inglott is a professor in the department of pharmacy, faculty of medicine and surgery at the University of Malta in Msida. [5], Takeda is reviewing all Gammagard Liquid orders and the company is allocating product as it becomes available. Learn more Residency Program Design and Conduct Virtual Workshops. [1-2], CSL Behring has Hizentra and Privigen on shortage due to increased demand. ; The U.S. Food and Drug Administration (FDA) only focuses on shortages of medically necessary drugs, as these have the potential to impact public health. The purpose of this memorandum is to communicate the Massachusetts Department of Public Health’s (the Department) awareness of ongoing nationwide Intravenous Immune Globulin (IVIG) shortages. On November 11, 2017, ASHP convened a roundtable of government and non-profit drug shortages stakeholders. AHFS 2019 Drug Information. Any application of this information for any purpose shall be limited to personal, non-commercial use. National drug shortages statistics and their interpretation. Am J Health Syst Pharm. 2020 Dec;158(6):2414-2424. doi: 10.1016/j.chest.2020.08.015. Boyle said the IVIg shortage will not end soon, but he encouraged the public to consider donating blood plasma. One manufacturer is even looking at utilizing intravenous immune globulin (IVIG) to treat some of the more rare autoimmune disorders such as encephalitis and PANS/PANDAS. McBride A, Holle LM, Westendorf C, Sidebottom M, Griffith N, Muller RJ, Hoffman JM. [6], Takeda has Gammagard on shortage due to increased demand. Bethesda, MD: American Society of Health-Systems Pharmacists; 2019: 3377-3397. Octapharma (personal communication). IVIG is an essential therapy for the treatment of many debilitating and/or life-threatening immunodeficiency and immune dysregulatory disorders. Clipboard, Search History, and several other advanced features are temporarily unavailable. Pfizer (personal communication). Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Impact of Ideal Body Weight Dosing for all Inpatient I.V.  |  2017;12:1530-1536. Results of EAHP's 2019 Medicines Shortages Survey. The American Society of Health-System Pharmacists (ASHP) has launched CareerPharm Rapid Connect, a new, free service to connect health care facilities with pharmacy personnel who can help alleviate potential staffing shortages during the coronavirus 2019 disease (COVID-19) pandemic. The authors have declared no other potential conflicts of interest. 2009 Aug 1;66(15):1399-406. doi: 10.2146/ajhp090026. ASHP Foundation Pharmacy Forecast 2020: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems. ASHP Expert Panel on Drug Product Shortages, et al. [1-2], CSL Behring is releasing Hizentra and Privigen regularly and distributors are allocating product. Miljković N, Batista A, Polidori P, Kohl S, Horák P. Eur J Hosp Pharm. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. * Ensure immune globulin is appropriate and necessary for the indication. Managing Drug Shortages. 2011 Sep;34(9):712-4. doi: 10.3928/01477447-20110714-15. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. So, if you’re facing an IVIG shortage, here’s my my patient-to-patient recommendation: Stay in continual communication with your prescribing provider. Catch up on interviews with pharmacy leaders, good news segments, member stories, and more, on ASHP TV. As such, we have high hopes we're going to see a lot of advancement of indications in 2018 and some new products being released. Takeda (personal communication). Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. DisclosuresDr. ASHP guidelines on managing drug product shortages. USA.gov. 72(4):285-289. The American Society of Health-System Pharmacists (ASHP) lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24 to 72 hours. COVID-19 is an emerging, rapidly evolving situation. [3], Grifols has Gamunex-C, Flebogamma, and Xembify available. Drug shortages: a complex health care crisis. January … July 11, August 26, and September 24, 2019; April 6 and August 28, 2020. Updated November 6, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Am J Health Syst Pharm. Multilevel Engagements of Pharmacists During the COVID-19 Pandemic: The Way Forward. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah, provided by ASHP as its exclusive authorized distributor, and used with permission. 2013. 2020 Aug 5;7:407. doi: 10.3389/fmed.2020.00407. It is a searchable database that provides up-to-date information for consumers and healthcare professionals related to current drug shortages. Government intervention. Explore. Drug Shortages: Root Causes and Potential Solutions examines the underlying factors responsible for drug shortages and recommends enduring solutions. 2014 Mar;89(3):361-73. doi: 10.1016/j.mayocp.2013.11.014. Notifying ASHP or FDA about a drug product shortage can initiate these efforts. Pharmacotherapy. [5], Octapharma has Cutaquig and Octagam available. NLM Am J Health Syst Pharm. Fox is a member of the AJHP Editorial Board. In: McEvoy GK, Snow EK, eds. Front Med (Lausanne). Make every attempt to maintain consistent therapy when possible. ASHP Supports the Mitigating Emergency Drug Shortages (MEDS) Act [10/28/19] Drug Shortage Legislative Objectives [08/28/19] ASHP Applauds Senators and Expresses Support for Drug Shortages Task Force [06/21/19] ASHP Letter to Leaders of the Oversight and Investigations Subcommittee on Shortage of Small-Volume Parenteral Solutions [11/9/17] American Society of Health-System Pharmacists (ASHP) - Find your next career at ASHP CareerPharm. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Learn More. The supplement can be found at: https://academic.oup.com/ajhp/issue/62/16_Supplement_3. This year, changes were made to adapt to the coronavirus disease 2019 (COVID-19) pandemic in order to continue to allow 340B stakeholders to have access to the PV’s distribution, education, and general assistance resources during the pandemic, according to a session at the 2020 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition. An analysis of the Northern Navajo Medical Center (NNMC) found that although opportunities grew due to provider shortages, pharmacists practicing at the top of their license have the ability to significantly improve access to care, particularly in areas revolving around medication management, according to a poster presented at the American Society of Health-System Pharmacists' (ASHP) virtual 2020 ASHP … Advertisement. A drug receives Resolved status when the Drug Shortages Staff (DSS) determines that the market is covered, based on information from all manufacturers. Created February 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. News & Views and ASHP TV. [4], Kedrion has Gammaked on allocation to its current customers. Organizations facing a shortage should consider the following actions: * Establish a task force or method to approve new starts and ongoing doses. Chest. Let them know when your symptoms start to escalate. Vermeulen LC, Swarthout MD, Alexander GC, Ginsburg DB, Pritchett KO, White SJ, Tryon J, Emmerich C, Nesbit TW, Greene W, Fox ER, Conti RM, Scott BE, Sheehy F, Melby MJ, Lantzy MA, Hoffman JM, Knoer S, Zellmer WA. Kedrion (personal communication). Rocchio MA, Hussey AP, Southard RA, Szumita PM. November 26, 2018; March 20 November 20, 2019; January 29, April 20, June 11, and August 28, 2020. National survey on the effect of oncology drug shortages on cancer care. 2020 Jan 8;77(2):84-112. doi: 10.1093/ajhp/zxz283. Anderson CR, Olson JA. 2013 Apr 1;70(7):609-17. doi: 10.2146/ajhp120563. October 17, November 28, December 3, 2018; January 9 and 17, April 2, March 20, April 24, September 24, November 20, 2019; January 29, June 4 and 26, and August 28, 2020. Mayo Clin Proc. eCollection 2020. Am J Health Syst Pharm. Am J Health Syst Pharm. ASHP has gathered guidance, tools, and background information to help pharmacists maintain effective patient care. ADMA Biologics (personal communication). © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. Front Public Health. Submitted information will be shared with ASHP's drug shortages team. eCollection 2020. Please enable it to take advantage of the complete set of features! Immune Globulin. Miljković N, van Overbeeke E, Godman B, Kovačević M, Anastasi A, Bochenek T, Huys I, Miljković B. Stump SE, Schepers AJ, Jones AR, et al. The market is considered covered when supply is available from at least one manufacturer to cover total market demand. Immune Globulin Doses with Changes in Serum Immunoglobulin G levels. ASHP Expert Panel on Drug Product Shortages, Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL. Drug Shortages Statistics.  |  Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. eCollection 2020. You might need to discuss other treatment options with their providers, which may include plasmapheresis or immunosuppressant medications. 2020 Dec 8;8:561924. doi: 10.3389/fpubh.2020.561924. What You Should Know. April 30, July 11, 2019; January 29, February 3, and April 6, 2020. Yet IVIG’s complicated manufacturing process, its scientific uncertainty, and even certain financial motivations are just some of the nuanced factors leading to shortage of the drug, which is used for patients whose immune systems are compromised by viruses or cancer treatments. Additional Information on Drug Shortages. HHS It Takes a Village…: Contending With Drug Shortages During Disasters. However, some manufacturers may not have all presentations available. Use alternatives if available. November 26, and December 10, 2018; January 17, February 11, March 20, April 24, and November 20, 2019; January 29, April 6, and June 26, 2020. [4], Kedrion Biopharma has Gammaked available to current customers. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. NIH Immune Globulin, Intravenous or Subcutaneous (Human), Bivigam solution for injection, ADMA Biologics, Immune globulin (human) 10%, 5 gram protein/50 mL bottle, NDC 59730-6502-01, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 10 grams protein/100 mL vial, NDC 69153-0005-02, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 20 grams protein/200 mL vial, NDC 69153-0005-03, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 5 grams protein/50 mL vial, NDC 69153-0005-01, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 0.5 grams protein/10 mL vial, NDC 69153-0004-01, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 10 grams protein/200 mL vial, NDC 69153-0004-04, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 2.5 grams protein/50 mL vial, NDC 69153-0004-02, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 20 grams protein/400 mL vial, NDC 69153-0004-05, Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 5 grams protein/100 mL vial, NDC 69153-0004-03, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 1 gram protein/10 mL bottle, NDC 00944-2700-02, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 10 gram protein/100 mL bottle, NDC 00944-2700-05, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 2.5 gram protein/25 mL bottle, NDC 00944-2700-03, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 20 gram protein/200 mL bottle, NDC 00944-2700-06, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 30 gram protein/300 mL bottle, NDC 00944-2700-07, Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 5 gram protein/50 mL bottle, NDC 00944-2700-04, Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 1 gram protein/10 mL vial, NDC 76125-0900-01, Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 10 gram protein/100 mL vial, NDC 76125-0900-10, Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 2.5 gram protein/25 mL vial, NDC 76125-0900-25, Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 20 gram protein/200 mL vial, NDC 76125-0900-20, Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 5 gram protein/50 mL vial, NDC 76125-0900-50, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 1 gram protein/10 mL vial, NDC 13533-0800-12, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 10 grams protein/100 mL vial, NDC 13533-0800-71, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 2.5 grams protein/25 mL vial, NDC 13533-0800-15, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 20 grams protein/200 mL vial, NDC 13533-0800-24, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 40 grams protein/400 mL vial, NDC 13533-0800-40, Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 5 grams protein/50 mL vial, NDC 13533-0800-20, Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 1 gram protein/5 mL vial, NDC 44206-0451-01, Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 10 grams protein/50 mL vial, NDC 44206-0455-10, Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 2 grams protein/10 mL vial, NDC 44206-0452-02, Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 4 grams protein/20 mL vial, NDC 44206-0454-04, Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 100 mL / 10 gram protein bottle, NDC 44206-0437-10, Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 200 mL / 20 gram protein bottle, NDC 44206-0438-20, Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 400 mL / 40 gram protein bottle, NDC 44206-0439-40, Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 50 mL / 5 gram protein bottle, NDC 44206-0436-05, Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 1 gram protein/5 mL single dose vial, NDC 13533-0810-05, Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 10 gram protein/50 mL single dose vial, NDC 13533-0810-50, Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 2 gram protein/10 mL single dose vial, NDC 13533-0810-10, Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 4 gram protein/20 mL single dose vial, NDC 13533-0810-20, ADMA Biologics has Bivigam on allocation through BioCare SD. Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages. CSL Behring (personal communication). According to the American Society of Health-System Pharmacists (ASHP) and the American Hospital Association (AHA), the Coronavirus Aid, Relief, and Economic Security (CARES) Act offers some provisions that address shortages of drugs and medical devices. Drug shortages statistics, and best practices, guidelines and publications related to drug … Drawing attention to the shortage may encourage production by other manufacturers, collaborative efforts to develop alternative therapies, and ad hoc training opportunities on the safe and effective use of alternatives. Front Med (Lausanne). This list differs from the FDA’s list as ASHP lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24-72 hours, whereas the FDA site focuses only on shortages of medically necessary drugs, as these have the potential to impact public health. Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals. At that time, many hospitals had their Pharmacy & Therapeutics Committees establish strategies to prioritize the IVIG available to hospital pharmacies. ASHP guidelines on managing drug product shortages Am J Health Syst Pharm. BioCare SD (personal communication). Small-Volume Parenteral Solutions Shortages: Suggestions for Management and Conservation (PDF - 153 KB). ASPEN is continually addressing the ongoing shortage of PN components by working with and maintaining communications with the FDA, pharmaceutical manufacturers, other professional healthcare organizations and clinicians to stay up to date on the status of shortages, collaborate to resolve shortages and to provide resources for managing shortages. Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. Interruptions in supply can present clinical and administrative challenges. The American Journal of Health-System Pharmacy supplement on immune globulin may be helpful for clinicians. Check back frequently as new jobs are posted every day. ASHP: Purpose: Provides information obtained from manufacturers about current shortages, estimated duration, and discontinuations and provides information about FDA’s and other stakeholders’ roles in addressing and preventing shortages: Notification of new shortages and status of ongoing shortages; drug shortage management resources: Audience: Public Epub 2018 Jul 30. Comparison of Weight-Based Dosing Strategies for Intravenous Immunoglobulin in Patients with Hematologic Malignancies. Immune Globulin Indications. 2018 Nov 1;75(21):1742-1750. doi: 10.2146/ajhp180441. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Two day residency program design and conduct workshops. November 5, 2020. Correlation of Weight-Based I.V. Grifols (personal communication). Epub 2020 May 29. 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