cookies and our, Drug shortage task force and critical care pharmacy team members huddled to discuss options for managing the shortage, A plan was proposed to centralize all supply from ADCs to the inpatient pharmacy to facilitate close inventory management, Restrictions were developed to ensure the supply was available for the most critical patients, Clinical restrictions were communicated to all providers, pharmacists, and nurses, All patients able to receive oral thiamine were recommended to switch as soon as clinically appropriate, Changes were made to the EHR, included adding an alert on IV thiamine orders to indicate the drug is on shortage, the current shortage restrictions, and alternative medications, such as oral thiamine. 3112). The issue of drug shortages demands attention and collaboration from everyone involved; from regulators to developers, end users, and patients. 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. has to offer. www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html. Robert D’Eramo, PharmD, is a PGY2 health system pharmacy administration resident at the University of Virginia (UVA) Medical Center. Thus, the decision was made to begin compounding these products in-house. Essential medications used to alleviate breathing difficulties, relieve pain and sedate coronavirus patients are in short supply. www.accessdata.fda.gov/scripts/drugshortages/default.cfm. 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. 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). Support from senior management to drive the drug shortage prevention programs, as well as well-defined metrics tailored to proactively identify the potential risk of a shortage, adequate resources for the prevention program and specific organizational goals to prevent shortages differentiated the companies who successfully avoided a shortage from those that did not. PDA is working together with regulators and in collaboration with other industry associations. While many healthcare providers believe that improving the patient financial experience is a critical step for their organization, few have done so successfully. 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. 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. "Those first-line therapies will be exhausted, so going to the (pharmacy and therapeutics) committee with substitutable items will need to be reviewed.". Kate Bidwell Horton, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. After the drug shortage management strategy has been chosen, implement the plan. of approved drugs, marketed unapproved drugs, and IND drugs may be considered medically necessary. Twitter: @JELagasse 3112). Rarely do payers, providers and local resources come together with the patient's well-being prioritized as a unifying mission. Notification was received of a possible shortage due to the inability to reorder the needed amount. "Our patients depend on our care systems to survive this disease," she said. FDA Drug Info Rounds pharmacists discuss the management of drug shortages and how the FDA’s role has changed in recent years. management of a drug shortage Drug shortage encountered Consult checklist for different supply avenues (Figure 2) Discuss drug shortage with patient and prescriber* Discuss drug shortage and alternative drug with patient and prescriber* NO YES * In many provinces, pharmacists are … Kate completed a PGY1 pharmacy residency at the Ohio State University Wexner Medical Center and a PGY2 residency in critical care at UVA. ... Healthcare mergers and acquisitions in 2016: Running list. Dexmedetomidine Premix Bottle 400 mcg/100 mL and 200 mcg/50 mL. Case studies of UVA’s management process for two recent drug shortages appear in SIDEBAR 2. 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. Keeping the EHR up to date drives the end user clinicians toward the available medications. Should a drug shortage create an ethical dilemma regarding allocation or rationing of drug supply, the physician champions enlist the Ethics Committee for guidance. 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. Because many of these drugs were also on national shortage, we needed to quickly develop and implement a new procurement strategy. 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 support 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 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. 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. Drug shortages in the United States routinely force doctors to ration medicine. cGMPs / QRM Process Incorporating Risk-Based Asset Management into Your Drug Shortage Prevention Program To maintain a focus on patient safety but also ensure reliable delivery of products when they are needed, companies need to combine their current QRM policies with risk-based asset management principles. 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. But how she knows that is a whole other story. Beyond-use dating considerations, centralizing sterile compounding and distribution activities, and flexibility allowed by the FDA should all be on the table. ASHP recently issued guidelines on managing drug shortages, including key concepts that should be included in drug shortage management plans.5 Components of ASHP’s guidelines include: UVA utilizes many of these strategies and incorporates this methodology into the work of the drug shortage task force. 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.. At any given point, the department is tracking more than 300 unique drug product shortages to assess their impact, develop and implement management strategies, and communicate to stakeholders across the health system. As a result, hospitals and health systems reduce cost and improve outcomes. Hospitals in hot spots see between a 150% and 600% increase in demand for drugs like Propofol, Fentanyl, Hydromorphone, Midazolam and neuromuscular blockers, according to BD's internal data. NO PURCHASE NECESSARY. Danielle completed a health system pharmacy administration residency training at UNC Hospitals and Clinics. Methods A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. Reason for shortage: Disruption of the manufacture of the drug. For such hospitals, relevant resources include the American Society of Health-System Pharmacists, the Institute for Safe Medicine practice, and group purchasing organizations such as Vizient, Premier and HealthTrust, said Dumitru. 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. Like what you've read? 1. shortage situations for all CDER products including those marketed under new drug applications (NDAs), biologics license applications (BLAs), 8 In the same survey, over one-third of physicians reported negative patient outcomes as a result of drug shortages. Complex patient needs throughout the health system, in conjunction with frequent drug shortages, can complicate the intricacies of providing excellent patient care. ASHP and its partners keep the public informed of the most current drug shortages. A holistic, risk-based framework at a product level for prevention and management of drug short-ages caused by manufacturing and quality issues. Care Collaboration Success for Improved Outcomes. The complementary contribution by PDA focuses on risk based prevention at a product level. Blue Link provides pharmaceutical distribution software for medical and pharmaceutical inventory management as part of an all-in-one ERP system. Experience has shown that physicians, in particular, desire to understand why the shortage is occurring. 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. There are also steps individual healthcare facilities can take, such as implementing inventory management software. A fully integrated electronic health record (EHR) facilitates medication ordering, distribution, administration, and documentation in patient care areas. For full official rules. 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. 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. enjoy more of what www.pppmag.com 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. "Items as first-line therapy will be in short supply," Flowers said. 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. UVA encountered an emergency situation recently when our primary 503B compounding facility was no longer licensed in the state of Virginia. 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. 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. When these issues arise, key physician stakeholders in the respective areas are engaged to provide clinical guidance and help determine a management plan. More shortages Centers for Disease Control and Prevention. Communication strategies may include: Leveraging the EHR for drug shortage communication can critically improve drug shortage management. Managing ongoing drug shortages is particularly challenging as these shortages now occur across the spectrum of drug therapies and are not limited to specific types of medications, formulations, or therapeutic classes. 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 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. Hospital systems across the country are looking to streamline their billing and collection processes to become more efficient and better compete in their markets. Her professional interests include pharmacy supply chain and contracting, drug shortages, utilization management, and pharmacy business development. Improving the Patient Financial Experience Throughout the Patient Journey. 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. The UVA pharmacy department utilizes medication carousels to store drug inventory in the central pharmacy of the medical center. Enter our US Food and Drug Administration. National guidelines for drug shortage management guide all task force initiatives (see SIDEBAR 11-5). Be sure to incorporate additions and deletions of available medications, as well as best practice alerts and limited medication administration alerts to communicate to the end user the reasons for the change and to denote the recommended alternative therapy. Action Plan: UPMC will focus on the Executive Summary Checklist in the following ways: Senior Leaders recognize the negative impact of drug … As pharmacy departments strive to manage the impact of persistent drug shortages, other organizations may be considering this option as well. His professional interests include health system and workflow optimization, infusion management practices, pharmacy technician advancement, and clinical pharmacy service expansion. The UVA Drug Shortages Task Force is an interdisciplinary team whose goal is to develop and oversee drug shortage management plans. The drug, with the brand name Pepcid, has been flying off the shelves since an observational study, which reached similar conclusions, was published in Gastroenterology in late May. Experience the education, innovation and collaboration of the HIMSS Global Health Conference & Exhibition… virtually. 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. The first step was to engage our contracting department and then attempt to expedite negotiations with a new vendor. Most health care organizations are not immune to drug shortages. That makes it critical for hospitals to leverage regulatory allowances to maximize the drug supplies that are on hand. Our clinics receive nearly one million patient visits annually. 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