Managing Drug Shortages: Stay Vigilant Drug shortages were a fact of life before the health crisis. Information from the American Society of Heath Systems Pharmacists Shortages … Hospitals must have clear, ethically defensible, and transparent allocation plans and policies in place to meet these challenges. 2 It is estimated that drug shortages are costing facilities at least $359 million per year in labor costs for implementing mitigation strategies to improve patient care. Epub 2018 Jul 30. Hinman AR, Orenstein WA, Santoli JM, et al. Managing drug product shortages can be extremely complex and pharmacy procurement and clinical staff are increasingly challenged in managing the effects of shortages. Wholesalers also played an important role in managing drug shortages. The document outlines best practice standards for managing Medicine Shortages in NHS hospitals and can be adapted and used to develop local policies and Standard Operating Procedures or where regional or other collaborative working is in operation, within STP footprints, for example. Drug shortages make both access to needed therapies and delivery of patient care challenging. 5 IMS Study Reveals Drug Shortages in U.S. That effort, led by the University of Utah Health’s Fox, covers both planning for drug-product shortages and responding when a shortage occurs. Am J Health Syst Pharm. Drug Shortages Drug shortages affect patients and the delivery of patient care. Am J Health Syst Pharm 66:1399–406 pmid:19635779 . 2009 Aug 1;66(15):1399-406. There is also the Special Access Program, which allows small-scale importation of medications not marketed in Canada. That effort, led by the University of Utah Health’s Fox, covers both planning for drug-product shortages and responding when a shortage occurs. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. It is still necessary to manage the way patients enter and proceed through the various nodes of the health care delivery system. Next, understand how your distributor communicates drug shortages. 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. But, health authorities say the situation has reached a critical tipping point. Measuring the hidden costs of drug shortages on U.S. hospitals. Are you shipping your purchase orders to my distributor in full? Receiving and communicating accurate and complete information is critical to managing a drug shortage. ASHP guidelines on managing drug product shortages in hospitals and health systems. By McKesson December 10, 2018. Managing drug product shortages can be extremely complex and pharmacy procurement and clinical staff are increasingly challenged in managing the effects of shortages. US$ Having the right amount of inventory is a true balancing act. The study found that 100% of the facilities surveyed were affected by drug shortages, and it’s estimated that hospitals spend an additional 8.6 million personnel hours annually managing the impact of drug shortages. Health Canada has several options available to mitigate drug shortages. Medication errors are more likely to occur (1) when a pharmacy alters how a product is ordered, prepared, or dispensed or (2) when prescribing practices change to less-familiar alternative agents, especially agents that are less efficacious, have a worse adverse-effect profile, or require an unusual or difficult dosing regimen. 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. The total number of new and ongoing shortages crossed the 450 mark in 2012 (1). 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. Medicines shortages can adversely affect ideal drug therapy, delay medical procedures and result in medication errors. We make no representations with regard to the content’s comprehensiveness. This is the core issue affecting Canada’s drug supply during the COVID-19 pandemic. October 5, 2012 - When critical drugs are in short supply, how does your organization handle it?. 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. * The information provided here is for reference only and does not constitute legal advice. The COVID-19 pandemic has highlighted the amount of work involved in managing these shortages, and that stakeholders must work together to ensure that Canadians have the medications they need, when they need them. managing drug product shortages in hospitals and health systems. free digital subscription Am J Health Syst Pharm. 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. Part II of our national survey on drug shortages: proactive guidelines to safely managing scarce supplies. 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. The reasons for drug shortages are complex and multifactorial. 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. Vaccine shortages: history, impact, and prospects for the future. APPROVAL BODY: Pharmacy and Therapeutics Committee APPROVAL DATE: 05/03/10 POLICY OWNER: Manager, Drug Information Service HISTORICAL INFORMATION ORIGIN DATE: 11/03 . To help your hospital or health system mitigate these outcomes, it is important to understand not only the underlying causes of drug shortages but also the proactive measures you can take and resources available to help you. Am J Health-Syst Pharm. 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. To provide guidance, the American Society of Health-System Pharmacists released new guidelines in 2018 for managing drug product shortages. Finally, increased demand can result in drug shortages. CDC Vaccine Shortages Website. Overall, Vizient estimates that managing drug shortages costs US hospitals about $360 million a year in additional labor alone. 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. Labor costs, according to the Vizient report, cost U.S. hospitals at least $359 million a year. “I’m here to tell you that drug shortages are not an occupational hazard, they’re not a nuisance or inconvenience to be managed by pharmacy,” she said. 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. 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. You are solely responsible for investigating and complying with all applicable laws that govern the operation of your business. This translated to $359 million of additional supply chain spend every year. Pooling of resources does not just apply to materials inventory. 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. tings because these facilities routinely treat patients with. Hospital News is Canada's health care newspaper since 1987. While social-distancing measures, travel restrictions, and shelter-in-place orders are effective in dampening demand, they are only part of the solution. How Your Hospital Pharmacy Can Manage Drug Shortages. By Jennifer Larson, contributor. 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. Hospitals also needed to raise their awareness of good inventory management, which can not only decrease drug shortages … A recent study from a team of researchers at Duke University Medical Center proposed a set of ethical standards for hospitals and health systems who are coping with the struggle to manage drug shortages. Hospital Pharmacy Technician's Letter includes: 12 issues every year, with brief articles about new meds and hot topics; 200+ CE courses, including the popular CE-in-the-Letter; Helpful, in-depth Technician Tutorials; CTRL + SPACE for auto-complete. The Canadian Society of Hospital Pharmacists (CSHP) also has a role to play in mitigating drug shortages. To learn about the status of a particular drug, consider contacting the manufacturer directly and asking the following questions: Don’t feed the gray market. Stay current with external and internal drug shortages. In hospitals, pharmacy managers and pharmacy technicians involved in drug distribution spend a considerable amount of time managing drug shortages. Drug Distribution and Control: Procurement–Guidelines 71 ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems Purpose Drug product shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in med-ication errors.1,2 Health care professionals are increasingly on Managing Drug Product Shortages in Hospitals and Health Systems. Transforming How Hospitals Identify and Manage Drug Shortages By Patrick Yoder, PharmD, co-founder and CEO, LogicStream Health. Recommendations include: View Article PubMed/NCBI Google Scholar 17. April 4, 2001;6(7):1-2. Manufacturers have a role in managing drug shortages, and it starts with advising Health Canada of any impending shortages that they foresee. Talk to your distributor about inventory optimization technologies and programs that can help you find the right solution for your needs. ASHP Report Managing drug product shortages ASHP report ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems Developed by an ASHP Expert Panel on Drug Product Shortages: Erin R. Fox, Annette Birt, Ken B. James, Heather Kokko, Sandra Salverson, and Donna L. Soflin Am J Health-Syst Pharm. ASHP guidelines on managing drug product shortages in hospitals and health systems. Small Volume Parenteral (SVP) Solutions Shortages: Suggestions for Management and Conservation, ASHP, 2017 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. The U.S. Government Accountability Office reports that the total number of active shortages, including both new and ongoing shortages from the prior year, has increased since 2007.2 According to a study on drug shortages, more than 80% of drugs in short supply are generics. Of those, 80% are injectables that treat cancer, cardiovascular disease, infection, central nervous system conditions and pain.3, Determining the causes of drug shortages is difficult. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. 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 … A shortage of minibags to mix intravenous medications had a huge impact on hospitals in North America in early 2018. Group purchasing organizations have a role in managing drug shortages for their member hospitals. The unpredictability of shipments adds to the difficulty of managing drug shortages. Our nurses are not okay: Protecting the mental health of... Inside-the-box’ technology solves organ and vaccine transportation problem, The lost years or a spectacular 2021: Health leadership in 2021, Transforming healthcare practice beyond COVID-19, Changing the model for case and contact management in public health. 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. ASHP guidelines on managing drug product shortages Am J Health Syst Pharm. The global drug shortage crisis has accelerated at an alarming rate during the COVID-19 crisis. Note. 2006;27:235-59. The University College Hospitals ‘Solutions’ website (now no longer operational) regularly reported between 120 and 150 current shortages. 1. Drug shortages are a cause of significant patient safety concerns. For many years, hospital pharmacists and pharmacy technicians have been managing significant drug shortages in Canadian hospitals. This shortage could not have been foreseen but speaks to the fragility of the supply chain when one manufacturer has such an impact on the operation of so many hospitals. With the drug shortage crisis skyrocketing, the potential for unsafe practices, compromised care and increase for potential errors also climbs. If you are uncertain, your account representative should be able to help. ASHP RePoRt Managing drug product shortages Am J Health-Syst Pharm—Vol 66 Aug 1, 2009 1399 ASHP rePort ASHP Guidelines on Managing Drug Product Shortages in Hospitals and … The escalation and management of medicines shortages, including dissemination of information to primary and secondary care organisations, is vital in ensuring continuity of supply and in ensuring patients receive the treatment and medication required. Natural disasters are unpredictable and can have a huge impact on the supply chain. 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. In fact, 90% of hospitals say they’ve experienced at least one shortage in the past six months that affected patient safety, and 99% said a shortage forced them to purchase a more expensive alternative.1. Methods: A national online survey was conducted to quantify the effects of drug shortages on patient care and pharmacy expenses. free digital subscription of hospital news! The European Parliament and the Council of the European Union (2011) DIRECTIVE 2001/83/EC OF THE EUROPEAN … The objectives of this research were to highlight challenges in the current pharmaceutical procurement process for public sector hospitals. One of the simplest reasons for a drug shortage would be a shortage of the raw materials required to make the Active Pharmaceutical Ingredient (API). Secondly, there could be a disruption in the supply chain, whereby some countries might close their borders temporarily or not be able to manufacture these medications at the same levels they were before. Please call 1-800-917-9489, or email us at info@pharmacists.ca. Also highlighted in the report as a challenge facing hospitals: medication shortages. Managing flow means proactively sha… In the past, drug shortages were an unexpected or occasional problem; now shortages are a daily occurrence for hospital pharmacists, who have had to learn how to implement creative strategies and contingency plans to make sure patients get the medications they … Another problem is secondary shortages. 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. These multi-stakeholder calls help to determine if a drug shortage will be considered critical, and they allow CSHP to gather and share information with their members. Drug shortages are significantly impacting pharmacy resources, staffing, budgets and patient care. Purchasing products from unofficial supply channels not only puts your patients at risk, as products may be contaminated and stored improperly, but it perpetuates the problem by keeping gray market wholesalers in business. 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. 8 Examining Drug Shortages and Recent Efforts to Address Them, U.S. Food and Drug Administration, Feb. 10, 2014 Are you reducing shipment quantities to my distributor? Managing drug shortages in the NHS : So far, the National Health Service has been able to deal with drug supply problems reasonably effectively. ISMP Medication Safety Alert! of hospital news! ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Managing drug product shortages is particularly complex for practitioners in hospitals and health systems (hereinafter, “health systems”), because these facilities routinely treat patients with acute or emergent conditions, use a significant number of medically necessary or single-source products, and use high-cost new drug technologies. Index terms: American Societ y of Health-System Pharmacists; Managing drug product shortages can be extremely complex and pharmacy procurement and clinical staff are increasingly chal-lenged in managing the effects of shortages. Evidence, economics and ethics: Resource allocation in health services organizations. Managing supply shortages poses significant ethical challenges. Data … ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. In an example cited by FIP, shortages cost U.S. hospitals US$ 416 million, i.e. 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. Group purchasing organizations have a role in managing drug shortages for their member hospitals. A reliable, resilient system to prevent, report, and manage drug shortages is needed. 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. Drug shortage drivers. 3. 2009; 66:1399–1406. Indeed, such plans and policies should be in place before shortage-induced allocation problems arise. Managing Drug Shortages: Stay Vigilant Drug shortages were a fact of life before the health crisis. 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. 2009 Aug 1;66(15):1399-406. doi: 10.2146/ajhp090026. Keep it balanced. Authors ... Pharmacy Service, Hospital / organization & administration Canadians would face less risk with their drug supply if effective measures could be put into place to reduce drug shortages. 2 The top 5 drug categories … Drug shortages in Malawi’s public hospitals are nothing new. Drug shortages have increased in number over recent years resulting in exacerbated medication safety concerns that impact the entirety of hospital operations. 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. 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