Managing Drug Shortages: Stay Vigilant Drug shortages were a fact of life before the health crisis. medically necessary or single-source products, and use high-. Am J Health Syst Pharm. An unanticipated, significant increase in the demand for specific medications results in shortages because manufacturers cannot quickly ramp up production of these medications. View Article PubMed/NCBI Google Scholar 17. Am J Health Syst Pharm 66:1399–406 pmid:19635779 . In an example cited by FIP, shortages cost U.S. hospitals US$ 416 million, i.e. The globalization of the drug supply means that production schedules are established 12-18 months or more in advance, and quickly pivoting to increase production of a specific medication is not always possible in the timeframe required. Indeed, such plans and policies should be in place before shortage-induced allocation problems arise. Either way, hospitals benefit from having easily accessible, historical data on how they’ve dealt with a drug shortage. Box 1: Medicines shortages: a widespread and persistent problem • In the U.S., new drug shortages rose from 70 in 2006 to a high of 267 in 2011. Additionally, hospitals should identify a point person who takes the lead in implementation, coordination and monitoring during a shortage. But if hospitals try to preemptively procure materials to gain an advantage over their rivals, it simply makes shortages worse. If they can be more active in promoting communication between the manufacturers and the hospitals, information can be shared in the supply chain more easily and most drug shortages can be avoided. Understanding drug shortages during a pandemic, Complementary Medicine and Alternative Therapies, 2020 Professional Development and Education, 2019 Canadian Society of Hospital Pharmacists Supplement, 2019 Professional Development & Education, Virtual care popularity surges during COVID-19 pandemic, A Pharmacy Resident’s experience during the COVID-19 pandemic, New clinical protocol after general surgery cuts opioid prescribing in half. 9 ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems, American Society of Health-System Pharmacists, Aug. 1, 2009, Business Consulting & Revenue Cycle Analytics, Oncology EHR, Regimen Support & Analytics, Food and Drug Administration Safety and Innovation Act, FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages, Verify Wholesale Drug Distributor Licenses. Hospital pharmacies are particularly hard hit, as they face daily challenges in finding creative solutions in order to maximize inventory and usage of medications on shortage. But, health authorities say the situation has reached a critical tipping point. Buyers and purchasing agents take the biggest hit, spending an average of 12 hours every week on managing drug shortages. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. After arming yourself with the right information, the next step is to provide timely communications to your team about potential shortages so they can act quickly to manage the risk to your organization and patients. Finally, increased demand can result in drug shortages. Fox RE, Birt A, Janes KB, Kokko H, et al. Collaborators: Clark T, Armitstead JA, Kienle P, Thomas MJ, Tillett L, Lanese TR, Ponto JA, Mosley CA, Davis NM, Lazzaro RR, Kaye T, Sakai RI, Barbaccia JG, Tribble D, Robinson … In the vignette example, the current supply of preservative-free MTX is only available in 250-mg vial sizes. 8 Examining Drug Shortages and Recent Efforts to Address Them, U.S. Food and Drug Administration, Feb. 10, 2014 October 5, 2012 - When critical drugs are in short supply, how does your organization handle it?. The Food and Drug Administration (FDA) has implemented several initiatives, including the FDA Safety and Innovation Act and Strategic Plan for Preventing and Mitigating Drug Shortages, to help reduce drug shortages over the long term. A third issue is that over the last 20-25 years, globalization, mergers, and acquisitions of drug companies have been significant, and the net result is fewer manufacturers for any given generic medication. free digital subscription of hospital news! Purpose: The impact of drug shortages on patient care, the resources used to manage drug shortages, and the cost associated with drug shortages were studied. 2009;66:1399-1406. Managing drug product shortages can be extremely complex and pharmacy procurement and clinical staff are increasingly chal-lenged in managing the effects of shortages. Hospital pharmacy leaders grow frustrated with lagging technology And in exceptional circumstances, such as the COVID-19 pandemic, an Interim Order from the Minister of Health gives Health Canada additional flexibility in securing a stable drug supply for the Canadian market. According to the Institute for Safe Medication Practices, more than 80% of health care practitioners surveyed said there is a lack of advance warning and information about the duration and/or cause of a drug shortage. It is also available by subscription. Medicines shortages can adversely affect ideal drug therapy, delay medical procedures and result in medication errors. First and foremost, pharmacists must ensure … ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. While social-distancing measures, travel restrictions, and shelter-in-place orders are effective in dampening demand, they are only part of the solution. Canadians would face less risk with their drug supply if effective measures could be put into place to reduce drug shortages. Vaccine shortages: history, impact, and prospects for the future. Fox ER, Birt A, et al. According to the FDA, these efforts helped prevent 170 new shortages in 2013.8 In addition, the pharmaceutical industry has launched its own initiatives to better prevent and forecast shortages. Box 1: Medicines shortages: a widespread and persistent problem • In the U.S., new drug shortages rose from 70 in 2006 to a high of 267 in 2011. Small Volume Parenteral (SVP) Solutions Shortages: Suggestions for Management and Conservation, ASHP, 2017 Unfortunately, because the drug supply chain is so complex, there is no simple solution to this problem and any measures that are taken would have to involve legislative, regulatory, diplomatic, and practical considerations. When a medication is assessed as being critically important for Canadians and at risk of being unavailable, Health Canada can expedite Establishment License Review, Submission Review and Lot Release for medications. By Jennifer Larson, contributor. Another problem is secondary shortages. Precious clinical hours lost to time-consuming activities required to manage drug shortages. Hinman AR, Orenstein WA, Santoli JM, et al. ASHP guidelines on managing drug product shortages. However, the average dose of IT MTX is only 12 mg. Because of the lack of preservative, the shelf life of an opened vial of preservative-free MTX is limited. April 4, 2001;6(7):1-2. Methods: A national online survey was conducted to quantify the effects of drug shortages on patient care and pharmacy expenses. Best Practice Standards for managing medicines shortages in NHS hospitals Published 2nd November 2018, updated 9th December 2020 Best Practice Standards for managing Medicines Shortages in Secondary Care first published by the Royal Pharmaceutical Society in … Another strategy for managing drug shortages is to avoid waste. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. If they didn’t know it before, the audience of hospital pharmacists and suppliers would soon learn that the persistent and dangerous effects of drug shortages are anything but sexy. Managing drug shortages, including PN components, requires a plan and an interprofessional team to provide input into developing the plan and to implement the plan during a shortage or outage. 1 Drug Shortages 2014: A Premier Healthcare Alliance Update, Premier, February 2014 In this edition of Ask a Supply Chain Expert, we asked Christopher Van Norman, director of operations for McKesson, how your hospital … To better equip your hospital or health system, consider the resources that you currently have at your disposal, including your pharmacy and supply chain leadership, your distribution partner and industry associations. These drug shortages not only posed a threat to patient care, but also the stability of the hospital supply chain. They are the bridge between the hospitals and suppliers and can request protective allocations be put in place if a critical medication is at risk of being in shortage. In an example cited by FIP, shortages cost U.S. hospitals … Hospital and health system pharmacies have been managing and mitigating the impact of drug shortages for years, relying on manual means, more man-hours, and data systems that fell short of delivering on their promises. The director of pharmacy should consider developing a plan for managing drug shortages. Christina Adams is Chief Pharmacy Officer at CSHP. Implement structured communications. 4 National Drug Shortages Annual New Shortages by Year January 2001 to December 31, 2014, University of Utah Drug Information Service, Accessed Feb. 1, 2015 Melissa Collins, CPhT, RPhT ; June 2013 - Vol.10 No. 6 - Page #6 Drug shortages have increased in number over recent years resulting in exacerbated medication safety concerns that impact the entirety of hospital operations. Hospital News is published monthly and is made available in distribution racks placed in high traffic areas in hospitals and related institutions across the country. medication errors. By Heather Cooley, Director of Supply Chain Services, McKesson, and Cathy Leventis, Director of Clinical Services, McKesson, Most health care organizations are not immune to drug shortages. Talk to your distributor about inventory optimization technologies and programs that can help you find the right solution for your needs. The University College Hospitals ‘Solutions’ website (now no longer operational) regularly reported between 120 and 150 current shortages. There are many stakeholders involved in managing drug shortages, and each has a specific role to ensure that the impact of drug shortages is minimized to the greatest extent possible. While quality and manufacturing issues are the most common cause of drug shortages, consolidation among manufacturers, intermittent lack of raw materials, recalls, regulatory enforcement, product discontinuations and natural disasters all play a role. Also highlighted in the report as a challenge facing hospitals: medication shortages. By McKesson December 10, 2018. To provide guidance, the American Society of Health-System Pharmacists released new guidelines in 2018 for managing drug product shortages. They can help you find accurate and timely information on drug shortages to ensure that your actions are as effective as possible. ASHP has a host of information to help your hospital or health system effectively respond to and manage drug shortages. 2 Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability, U.S. Government Accountability Office, Feb. 10, 2014 2009 Aug 1;66(15):1399-406. doi: 10.2146/ajhp090026. 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