managing drug product shortages in hospitals and health systems. 2009 Aug 1;66(15):1399-406. doi: 10.2146/ajhp090026. free digital subscription ASHP Expert Panel on Drug Product Shortages, Fox ER, Birt A, James KB, et al. A pandemic generates an enormous demand shock for health care systems already running at close to full capacity. APPROVAL BODY: Pharmacy and Therapeutics Committee APPROVAL DATE: 05/03/10 POLICY OWNER: Manager, Drug Information Service HISTORICAL INFORMATION ORIGIN DATE: 11/03 . 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. 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. 2009; 66:1399-406 Purpose Commission,10 the … If, in your practice, you are aware of critical drug shortages that necessitate changes to a patient’s drug therapy, and have developed a unique way of managing the situation, please share your experience with us. 3 IMS Study Reveals Drug Shortages in U.S. This was seen in the early weeks of the COVID-19 pandemic, when India temporarily halted export of medications and API, and when Chinese manufacturing capabilities were significantly impacted by the effect of the virus on their workforce. * The information provided here is for reference only and does not constitute legal advice. Ultimately, drug shortages create uncertainty for a range of stakeholders: patients, hospitals, manufacturers, pharmacists and others. 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. Stay current with external and internal drug shortages. Gibson JL, Martin DK, Singer PA. 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. Labor costs, according to the Vizient report, cost U.S. hospitals at least $359 million a year. With the drug shortage crisis skyrocketing, the potential for unsafe practices, compromised care and increase for potential errors also climbs. Recommendations include: 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. October 5, 2012 - When critical drugs are in short supply, how does your organization handle it?. To provide guidance, the American Society of Health-System Pharmacists released new guidelines in 2018 for managing drug product shortages. acute or emergent conditions, use a significant number of. Either way, hospitals benefit from having easily accessible, historical data on how they’ve dealt with a drug shortage. Talk to your distributor about inventory optimization technologies and programs that can help you find the right solution for your needs. 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. Hospital News covers developments and issues that affect all health care professionals, administrators, patients, visitors and students. If one of the four or five manufacturers left have an issue with their supply chain, it puts additional pressure on the others to make up for that lack of supply in the Canadian market. Group purchasing organizations have a role in managing drug shortages for their member hospitals. To provide guidance, the American Society of Health-System Pharmacists released new guidelines in 2018 for managing drug product shortages. Christina Adams is Chief Pharmacy Officer at CSHP. Please call 1-800-917-9489, or email us at info@pharmacists.ca. CSHP continues to call for collaboration between industry, governments, wholesalers, healthcare providers and other stakeholders to minimise drug shortages and mitigate their effects. If a manufacturer has a limited supply of a drug, it may not be able to support a high-volume order from a distributor. ASHP Expert Panel on Drug Product Shortages(1), Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL. 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). 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. 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. Canadians would face less risk with their drug supply if effective measures could be put into place to reduce drug shortages. Managing drug product shortages can be extremely complex and pharmacy procurement and clinical staff are increasingly challenged in managing the effects of shortages. If you have a limited supply, can you ship drugs directly to my facility. 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. Fox ER, Birt A, et al. Having the right amount of inventory is a true balancing act. Transforming How Hospitals Identify and Manage Drug Shortages By Patrick Yoder, PharmD, co-founder and CEO, LogicStream Health. It is still necessary to manage the way patients enter and proceed through the various nodes of the health care delivery system. By McKesson December 10, 2018. The objectives of this research were to highlight challenges in the current pharmaceutical procurement process for public sector hospitals. 3. 2009; 66:1399-406. 7 Global Initiative, U.S. Food and Drug Administration, Accessed Feb. 1, 2015 Overall, Vizient estimates that managing drug shortages costs US hospitals about $360 million a year in additional labor alone. Drug shortages are significantly impacting pharmacy resources, staffing, budgets and patient care. Am J Health Syst Pharm 66:1399–406 pmid:19635779 . Another problem is secondary shortages. View Article PubMed/NCBI Google Scholar 17. Keeping inventory too lean can cause issues, but stockpiling a formerly scarce product once it becomes available is not a good practice either. 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. 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. 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 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. 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. 2006;27:235-59. While social-distancing measures, travel restrictions, and shelter-in-place orders are effective in dampening demand, they are only part of the solution. Epub 2018 Jul 30. 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. 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. A reliable, resilient system to prevent, report, and manage drug shortages is needed. Natural disasters are unpredictable and can have a huge impact on the supply chain. Some of the mitigating strategies are: to obtain different pack sizes or concentrations of backordered medications; to use other medications from the same therapeutic class; to compound medications in-house, if possible; to use medications from a different therapeutic class but with a similar mechanism of action; and, most significantly, to help determine which patient populations are prioritized for access to the limited supply of the medication. 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. 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. Manufacturers have a role in managing drug shortages, and it starts with advising Health Canada of any impending shortages that they foresee. Other resources that you may find helpful include: In conclusion, drug shortages are a complex, global issue. The global drug shortage crisis has accelerated at an alarming rate during the COVID-19 crisis. Tired of evaluating and choosing drug alternatives only to find they aren’t available from your suppliers? Drug shortages. 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. The Canadian Society of Hospital Pharmacists (CSHP) also has a role to play in mitigating drug 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. Methods: A national online survey was conducted to quantify the effects of drug shortages on patient care and pharmacy expenses. ISMP. 2009;66:1399-1406. 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 … Next, understand how your distributor communicates drug shortages. The University College Hospitals ‘Solutions’ website (now no longer operational) regularly reported between 120 and 150 current 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. Disruptive Yet Narrowly Concentrated, IMS Institute for Healthcare Informatics, Nov. 14, 2011 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. That effort, led by the University of Utah Health’s Fox, covers both planning for drug-product shortages and responding when a shortage occurs. 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. There is also the Special Access Program, which allows small-scale importation of medications not marketed in Canada. The reasons for drug shortages are complex and multifactorial. CSHP participates in calls with Health Canada and other stakeholders such as the Provinces and Territories, the manufacturers, the group purchasing organizations and other healthcare associations. Managing Drug Shortages Get unlimited access through an Enterprise license. Drug shortages in Malawi’s public hospitals are nothing new. Best practices for managing drug shortages must first consider the potential impact on patient safety. This translated to $359 million of additional supply chain spend every year. When your patients need acute care, they can’t wait. 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. 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. Data … ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. 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. Health Canada has several options available to mitigate drug shortages. 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. Researchers Propose Standards for Managing Drug Shortages. Managing Drug Shortages: Stay Vigilant Drug shortages were a fact of life before the health crisis. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. ISMP Medication Safety Alert! For many years, hospital pharmacists and pharmacy technicians have been managing significant drug shortages in Canadian hospitals. plex for practitioners in hospitals and other acute care set-. Drug shortage drivers. Am J Health Syst Pharm. In an example cited by FIP, shortages cost U.S. hospitals … 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. Drug shortages are significantly impacting pharmacy resources, staffing, budgets and patient care. Medicine shortages are a complex global challenge affecting all countries. Drug shortages make both access to needed therapies and delivery of patient care challenging. According to the American Society of Health-Systems Pharmacists (ASHP), close to 200 drugs are currently on the drug shortage list in the U.S. alone. Drug shortage drivers. Managing drug product shortages is particularly com-. Managing supply shortages poses significant ethical challenges. 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. Managing flow means proactively sha… Evidence, economics and ethics: Resource allocation in health services organizations. CDC Vaccine Shortages Website. 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. ASHP has a host of information to help your hospital or health system effectively respond to and manage drug shortages. Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL (2009) ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. The total number of new and ongoing shortages crossed the 450 mark in 2012 (1). 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. To help your hospital better prepare for a drug shortage, consider the following best practices: Have a plan. Hinman AR, Orenstein WA, Santoli JM, et al. Drug Shortages Drug shortages affect patients and the delivery of patient care. ASHP guidelines on managing drug product shortages in hospitals and health systems. CTRL + SPACE for auto-complete. “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. Precious clinical hours lost to time-consuming activities required to manage drug shortages. The unpredictability of shipments adds to the difficulty of managing drug shortages. 1. CSHP also helps to bring attention to the issue so that the Canadian public understands the rationale for some of the decision-making around drug shortages. tings because these facilities routinely treat patients with. Measuring the hidden costs of drug shortages on U.S. hospitals. Medicines shortages can adversely affect ideal drug therapy, delay medical procedures and result in medication errors. 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 … Drug availability and shortage issues can make it difficult for your hospital pharmacy to supply the drugs needed for that care. ASHP guidelines on managing drug product shortages Am J Health Syst Pharm. medication errors. Disruptive Yet Narrowly Concentrated, IMS Institute for Healthcare Informatics, Nov. 14, 2011 You are solely responsible for investigating and complying with all applicable laws that govern the operation of your business. 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. 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. Finally, increased demand can result in drug shortages. 5 IMS Study Reveals Drug Shortages in U.S. According to the U.S. Food and Drug Administration (FDA), shortages continue to increase. Drug shortages have become so commonplace that hospital pharmacists are now experts in adapting to the ever-changing scene. 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 … Wholesalers also played an important role in managing drug shortages. It is also available by subscription. Managing drug shortages in the NHS : So far, the National Health Service has been able to deal with drug supply problems reasonably effectively. 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. 1 Drug Shortages 2014: A Premier Healthcare Alliance Update, Premier, February 2014 2009;66:1399-1406. of hospital news! 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