UVA encountered an emergency situation recently when our primary 503B compounding facility was no longer licensed in the state of Virginia. Moreover, because multiple shortages can occur simultaneously, a comprehensive approach is crucial to minimize the impact of shortages on patient care. 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. The first step was to engage our contracting department and then attempt to expedite negotiations with a new vendor. This notification triggered an investigation into the shortage situation, as well as an assessment of days remaining on-hand based on current usage and purchase data. Additionally, over 200 automated dispensing cabinets (ADCs) are located throughout patient care units, procedural areas, and ambulatory clinic areas to provide quick access to medications. Specific execution steps include outlining the various action steps, determining timelines, and identifying task owners. Call : 1-877-258-5465 Industry PDA is working together with regulators and in collaboration with other industry associations. According to the FDA, a drug shortage occurs when “the total supply of all clinically interchangeable versions of an FDA‐regulated drug product is inadequate to meet the projected demand at the user level.” 10 Drug shortages have existed for decades; however, historically they were more infrequent and relatively short‐lived and were not broadly disruptive to patient care. Despite the challenging realities of drug shortages, the top priority is to maintain safe medication practices throughout the health system, which requires incorporating safe medication practices throughout the shortage and monitoring practice with safety reporting tools. ASHP Guidelines on Managing Drug Product Shortages. That makes it critical for hospitals to leverage regulatory allowances to maximize the drug supplies that are on hand. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. She received her PharmD from Virginia Commonwealth University School of Pharmacy. Experience the education, innovation and collaboration of the HIMSS Global Health Conference & Exhibition… virtually. Current Burden of Drug Shortages. 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. Perry Flowers, vice president of medical affairs, enterprise medication management at BD, said during a HIMSS20 digital presentation that drug supply needs are changing quickly as society becomes overwhelmed by high acuity patients. National shortage references were consulted to identify additional information, including the reason driving the shortage and the expected duration of the shortage. Hence in many ways, legislation and regulatory processes for shortage-related work are under-developed. Communication strategies may include: Leveraging the EHR for drug shortage communication can critically improve drug shortage management. But how she knows that is a whole other story. Accessed February 26, 2019. National Guidance for Drug Shortage Management. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. “When we’re aware of a shortage, we look at whether we use the drug, how much we have in inventory and when the shortage is expected to be over,” Mandy Leonard, system director of drug-use policy and formulary management in the Cleveland Clinic’s pharmacy … Utilizing a drug shortage task force has been instrumental in UVA’s approach to shortages management. Drug Shortage. Void where prohibited by law. Alerts can be added upon order entry, including pertinent restrictions or patient criteria, as well as the available alternative medications. Odds of winning depend on the number of eligible entries received. Open to persons 18 years of age or older at the time of entry. Direct inventory is decreasing while patients are undergoing therapy for coronavirus, and so an essential task for all caregivers, said Flowers, is recognizing and calculating the current supply burden and when it will be drained. 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. At UVA, any clinical prescribing changes are validated by clinical and operational stakeholders, and bar code scanning integration is utilized in all care areas so that patients receive the correct medication. 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. Email the writer: jeff.lagasse@himssmedia.com, No subscriptions were selected or subscribe error happened.Please contact the customer service. Kate Bidwell Horton, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. Our clinics receive nearly one million patient visits annually. As a result, hospitals and health systems reduce cost and improve outcomes. Proactively communicate drug shortages information to frontline care providers of multiple disciplines, including (but not limited to) physicians, nurses, respiratory therapists, and nutritionists. Regardless of the drug shortage in question, continuous communication between pharmacy management and clinicians and an ongoing prospective review of inventory are crucial to a successful management strategy. She received her PharmD from the University of North Carolina at Chapel Hill and completed a pharmacy practice residency at UVA. 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.. Utilizing a safety and error reporting tool to capture issues from frontline providers can be helpful; monitor this database throughout a shortage to reduce safety concerns. management of drug. Information provided includes: Guidance for how to respond to drug shortages is provided by various organizations, including the FDA, Centers for Disease Control and Prevention (CDC, for vaccine shortages), and the Institute for Safe Medication Practices (ISMP).1-4 Hospitals, providers, and pharmacists should use these resources when developing drug shortage management plans. Pamela Peele knows that people who subscribe to cooking magazines have a much higher risk of going to the emergency room. All pharmacy staff are invited to attend task force huddles and meetings, and are strongly encouraged to attend if a drug shortage could potentially affect patient care in their practice area. www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html. Twitter: @JELagasse Multiple shortage management guidance documents indicate a multidisciplinary team should be involved in implementing a systematic approach to decision-making in response to shortages. Additionally, we began a market search for new 503B vendors that could meet both our portfolio and volume requirements. As pharmacy departments strive to manage the impact of persistent drug shortages, other organizations may be considering this option as well. Related Information. National listings of drug shortages are available from the FDA and ASHP1,2; these websites list drugs currently on shortage and provide high-level guidance on individual drug shortages. 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). "Essential" medication during the coronavirus means not just medications for direct treatment of the disease, but also those drugs for supportive care, such as oral care for ventilator patients. Swabs, IV lines and drugs can be depleted very quickly, so hospitals should be keeping a tight list of those critical supplies. Each day, new drugs are identified as unable to procure, triggering an investigation into alternatives. Drug shortages are a relentless reality of daily workflow for the pharmacy department. 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. 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. How do revenue cycle leaders navigate payment reform while maintaining stable business office operations? Partnering with vendors to automate parts of the process can impact how quickly alternative drugs can be imported for a shorted drug.". As shortages appear to be ongoing, utilizing a comprehensive approach moving forward is prudent. Click here to view a larger version of this Table. System alignment and the rapid adaption of the existing framework for drug shortage management and medication use policy were cruc … While many healthcare providers believe that improving the patient financial experience is a critical step for their organization, few have done so successfully. Keeping the EHR up to date drives the end user clinicians toward the available medications. Some observers have hinted that a pharmaceutical company may be partly to blame for the vincristine shortage, given the company’s … 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. 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. 1. Should a drug shortage create an ethical dilemma regarding allocation or rationing of drug supply, the physician champions enlist the Ethics Committee for guidance. 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. Accessed February 26, 2019. Upon identification of a potential shortage, accurately assessing the situation is vital. Return to FDA Drug Info Rounds Page. See TABLE 1 for a description of UVA Drug Shortages Task Force members and their responsibilities. This scoping review aimed to systematically synthesise the literature to report on the economic, clinical, and humanistic impacts of medication shortages on patient outcomes. Blue Link provides pharmaceutical distribution software for medical and pharmaceutical inventory management as part of an all-in-one ERP system. The nature of our healthcare ecosystem has been one of siloed care. ASHP and its partners keep the public informed of the most current drug shortages. Commitment Summary: UPMC will commit to continuing implementation of interdisciplinary, rapid response drug shortage management teams and will support development of technology solutions to improve drug shortage prevention and mitigation. Complex patient needs throughout the health system, in conjunction with frequent drug shortages, can complicate the intricacies of providing excellent patient care. Drug shortages in the United States routinely force doctors to ration medicine. FDA Drug Shortages. 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