Twitter: @JELagasse Methods Medline, Embase, Global Health, PsycINFO and International Pharmaceutical Abstracts were searched using … ASHP Guidelines on Managing Drug Product Shortages. The University of Virginia Health System’s Management Process for Two Recent Drug Shortages. Semi-structured interviews were performed to … The University of Virginia Health System (UVA) is a tertiary-care, academic medical center with approximately 615 beds, over 29,000 inpatient admissions per year, and a level 1 trauma center with over 62,000 ED visits per year. The risk management plan will be subject to review during an inspection of the manufacturer (Sec. As shortages appear to be ongoing, utilizing a comprehensive approach moving forward is prudent. To effectively respond to drug product shortages, several essential elements of infra- Experience has shown that physicians, in particular, desire to understand why the shortage is occurring. Drug Shortage. Thus, UVA developed a multifaceted strategy to address drug shortages, including utilizing a drug shortages task force to oversee all shortage management in order to assuage the impact of shortages on patient care and workflow. US Food and Drug Administration. Drug shortage management strategies are needed during COVID-19 pandemic Jeff Lagasse , Associate Editor The rapidly escalating demand for medications due to COVID-19 is placing increased pressure on hospitals and health systems to appropriately manage drug inventory to … These safety precautions help to confirm that medication use during a shortage is equally as safe as when the shortage has resolved. Experience the education, innovation and collaboration of the HIMSS Global Health Conference & Exhibition… virtually. The Millennium Alliance Healthcare Provders Transformation LogicStream Health will be participating in The Millennium Alliance’s Healthcare Providers Transformation Virtual Assembly December 1 and 2, 2020.Learn more now. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. Your sweepstakes entry has been recorded! Danielle A. Griggs, PharmD, MBA, MS, BCPS, is the pharmacy manager for procurement, utilization management, and business services at the University of Virginia Medical Center in Charlottesville, Virginia. Although quality-reporting programs such as meaningful use provide incentives to help providers implement and use electronic health records (EHRs) to collect and report on clinical data, practices often need help deciding what data to collect, which measures to report ... Debunk the Myth: Outsourcing Doesn't Mean Losing Control. FDA Drug Shortages. Drug shortages are common in today’s environment. While 2015 was a record-breaking year in healthcare mergers and acquisitions, 2016 saw more change as organizations across the industry adjust and adapt to the evolving financial landscape. Multiple shortage management guidance documents indicate a multidisciplinary team should be involved in implementing a systematic approach to decision-making in response to shortages. With these strategies in place, a good rule of thumb is to prepare at least two alternatives to every critical drug and establish a process for switching back and forth – which is necessary due to the erratic fluctuation of COVID-19-related drug utilization and medication availability. Kate Bidwell Horton, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. NO PURCHASE NECESSARY. The Food and Drug Regulations require drug sellers to report when they are not able to meet demand for a product or when they stop selling a product. She received her PharmD from the University of North Carolina at Chapel Hill and completed a pharmacy practice residency at UVA. It is essential that this group comprises interdisciplinary representation of all stakeholders impacted by drug shortages; therefore, the team includes key members who assess drug shortages, implement management strategies, and monitor changes in an expedited fashion. Swabs, IV lines and drugs can be depleted very quickly, so hospitals should be keeping a tight list of those critical supplies. www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html. See TABLE 1 for a description of UVA Drug Shortages Task Force members and their responsibilities. PDA is working together with regulators and in collaboration with other industry associations. He is a graduate of the Virginia Commonwealth University School of Pharmacy, where he received his PharmD in 2017. The methods of procuring and distributing medications are often health system-specific; therefore, each organization will require a unique framework for implementing mitigation plans that address inventory management during shortages. Specific execution steps include outlining the various action steps, determining timelines, and identifying task owners. Thank you, © 2021 Healthcare Finance is a publication of HIMSS Media, Study finds racial bias in Optum algorithm, UPDATED: List of 2020 Medicare Advantage star ratings, Curbing administrative complexity to slash waste, Analyze this: Health systems, health plans get to the core of big data. Reason for shortage: Disruption of the manufacture of the drug. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. Drug Shortages. When these issues arise, key physician stakeholders in the respective areas are engaged to provide clinical guidance and help determine a management plan. Upon identification of a potential shortage, accurately assessing the situation is vital. Because of this, healthcare organizations need inventory- and shortage-management strategies to weather the storm. Incorporating this information in the EHR is key to help clinicians appropriately respond to shortages and select suitable alternatives for patients. Click here to view a larger version of this Table. The assessment should include the following components5: When assessing the depth and breadth of a shortage, and identifying operational or therapeutic alternatives, it is essential that the drug shortage task force consider the downstream impact of the shortage to providers and to the organization, including the risks and safety concerns related to: Incorporate safe medication use practices throughout the drug shortage management plan. 2. ... Healthcare mergers and acquisitions in 2016: Running list. enjoy more of what www.pppmag.com While we were not privy to the exact drivers that led to this result, we were made aware that within a few weeks we would not receive a large number of medications that had been primarily sourced from this vendor. National Guidance for Drug Shortage Management. There are also steps individual healthcare facilities can take, such as implementing inventory management software. Read this brief to learn strategies that increase patient ... 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The pharmacy department can lead effective drug shortage management by ensuring that its organization has the neces-sary infrastructure and a well-defined management strategy in place before a shortage occurs. Keeping the EHR up to date drives the end user clinicians toward the available medications. Accessed February 26, 2019. Her professional interests include pharmacy supply chain and contracting, drug shortages, utilization management, and pharmacy business development. While they cannot control drug shortages, health system pharmacists can use RFID healthcare technology to optimize existing drug inventory and reduce drug waste Surviving Drug Shortages with Improved Inventory Management Methods A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. These events led to an in-depth, organization-wide discussion of the possibility of investing in internal development of 503B compounding capabilities to mitigate the impact of external vendor challenges. More shortages Keep the health information management system up-to ... and business analytics software ... sense of what could be coming on the market as a shortage," he says. ISPE recognizes that there are many other factors that may impact the supply of drugs, including regional economic factors, differing regulatory requirements, insurance programs, and government procurement procedures; however, these are outside the scope of the Drug Shortages Prevention Plan. With drug shortages involving potentially all segments of the supply chain—for example, raw material vendors, pharmaceutical manufacturers, suppliers, and federal regulators—identifying a shortage may involve various steps. A risk triage model that can be used to assess drug shortage risks and implement appropriate con - trols in the end-to-end value chain for manufacturing and distribution of a product. Medication safety expertise is paramount when developing and reviewing drug shortage management strategies. Drug shortages in the United States routinely force doctors to ration medicine. Once-failing hospitals say accountability, transparency key to surviving fallout from failing patient safety grades. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. System alignment and the rapid adaption of the existing framework for drug shortage management and medication use policy were cruc … Moreover, because multiple shortages can occur simultaneously, a comprehensive approach is crucial to minimize the impact of shortages on patient care. 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… Proactively communicate drug shortages information to frontline care providers of multiple disciplines, including (but not limited to) physicians, nurses, respiratory therapists, and nutritionists. The task force evaluates shortages and identifies appropriate management strategies, which may include: Each of these strategies delivers benefits as well as risks (see TABLE 2). "Analytics becomes essential for survival during this process," said Dumitru. www.pppmag.com uses cookies. In addition, do not neglect to investigate the financial impact of the shortage on the health system, including the additional costs of purchasing alternative therapies, added labor to support the process changes, technical system changes, contract or purchasing compliance, and the costs of in-house pharmacy preparation and the overhead associated with these preparations. When the shortage was determined to be resolved: EHR changes were reversed and the alert was removed, Communication sent via email to all groups notifying them that the shortage was resolved, Stacey B. Pattie, PharmD, BCPS, Danielle A. Griggs, PharmD, MBA, MS, BCPS, Redeploy Pharmacy Technicians to Advanced Roles, Formulary Management of Novel Drug Therapies, Trends in Medical-Grade Refrigeration Adoption, Allocating/rationing the remaining supply, Targeted messaging to affected user groups (ie, staff huddles), Routine messages communicating updates to a larger audience (ie, email communications), Employing a reference database that allows clinicians to research pertinent information, Maximizing use of real-time alerts in the EHR. For full official rules. Drug Shortages and Management Drug shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors. She completed her PharmD and MBA at the University of Kentucky, and received an MS from the University of North Carolina Eshelman School of Pharmacy. Patient inconvenience alone is an insufficient reason to classify a drug product as medically necessary.” CDER Manual of Policies and Procedures on Drug Shortage Management 4190.1 Rev 2 www.ismp.org/resources/drug-shortages-continue-compromise-patient-care. "Items as first-line therapy will be in short supply," Flowers said. Robert D’Eramo, PharmD, is a PGY2 health system pharmacy administration resident at the University of Virginia (UVA) Medical Center. National guidelines for drug shortage management guide all task force initiatives (see SIDEBAR 11-5). Odds of winning depend on the number of eligible entries received. Identify and Assess the Impact of the Shortage. Because many of these drugs were also on national shortage, we needed to quickly develop and implement a new procurement strategy. Drug Shortages Continue to Compromise Patient Care (January 11, 2018). Danielle completed a health system pharmacy administration residency training at UNC Hospitals and Clinics. Current Burden of Drug Shortages. Doina Dumitru, senior director of medical affairs, enterprise medication management at BD, said the role of data analytics is made more critical as drug shortages put more pressure on healthcare organizations. The nature of our healthcare ecosystem has been one of siloed care. Get Started >>. In this edition of Ask a Supply Chain Expert , we asked Christopher Van Norman, director of operations for McKesson, how your hospital pharmacy can use its supply chain to minimize the risk to patients. Our health system’s approach to shortage management has evolved over time as shortages have increased in quantity, complexity, and in their potential to impact patient care. 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.. Drug availability and shortage issues can make it difficult for your hospital pharmacy to supply the drugs needed for that care. Eventually, many drugs on the short list will require substitutions, and anticipating when that situation will happen is a key goal in the use of any analytics tool. Rarely do payers, providers and local resources come together with the patient's well-being prioritized as a unifying mission. Beyond-use dating considerations, centralizing sterile compounding and distribution activities, and flexibility allowed by the FDA should all be on the table. "You should track the drug inventory level, but speed of acquisition is also important. Developing a drug shortage management team, Determining the impact of the shortage on patient care, Drug shortage task force members huddled to discuss options for managing the shortage, A plan was proposed to begin compounding patient orders in the IV room and leave the remaining premix supply in procedural area ADCs to facilitate quick access, The available inventory of supplies required to compound these infusions was assessed (eg, dexmedetomidine 200 mcg/mL vials); par adjustments were made to accommodate increased use, Direct order allocations and back orders with the wholesaler were utilized to obtain as much inventory as possible of premixed solution, Modified EHR to allow for doses prepared by IV room, Communicated with IV room staff regarding required changes in process due to shortage, Communicated facility-wide with specific information to nurses, pharmacists, and OR providers, The IV room stopped dispensing the compounded product, Inventory levels of products used in the IV room were reduced to pre-shortage levels. The successful navigation of drug shortages is contingent on an organization’s capacity to quickly identify the shortage, proactively develop a mitigation plan, and efficiently put that plan into action. Robert completed a PGY1 pharmacy residency at the UVA health system in 2018 and is currently pursuing a Master of Health Administration from Virginia Commonwealth University. Sweepstakes now for your chance to win the following prizes: Just answer the following quick question for your chance to win: To continue, you must either login or register: Entries are limited to one entry per person in any active sweepstakes. Drug shortage management begins when the first piece of information regarding a supply interruption is received; this could include a notification from a manufacturer or supplier, or an inability to restock to desired levels. As a subcommittee of the P&T committee, the task force has the authority to develop and enforce formulary restrictions to mitigate the impact of shortages on patient care. When Leapfrog released their Spring 2016 patient safety grades recently, 15 hospitals got slapped with a very public 'F' grade casting a spotlight on them that no institution wants. Current Vaccine Shortages & Delays. 1. Meeting twice weekly, the task force assesses and manages drug shortages in real time. Read how these organizations are getting it right. Coping with these disruptions can prove frustrating and time-consuming for pharmacists and providers, yet proactive management is critical, as the risks of ineffective or inefficient management can be deadly for patients. Communication strategies may include: Leveraging the EHR for drug shortage communication can critically improve drug shortage management. 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