Robert D’Eramo, PharmD, is a PGY2 health system pharmacy administration resident at the University of Virginia (UVA) Medical Center. 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. 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 … www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Reason for shortage: Disruption of the manufacture of the drug. 1. shortage situations for all CDER products including those marketed under new drug applications (NDAs), biologics license applications (BLAs), 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. Email the writer: jeff.lagasse@himssmedia.com, No subscriptions were selected or subscribe error happened.Please contact the customer service. 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. 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. A fully integrated electronic health record (EHR) facilitates medication ordering, distribution, administration, and documentation in patient care areas. www.ashp.org/Drug-Shortages. “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 … After the drug shortage management strategy has been chosen, implement the plan. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. As of February 2019, the FDA is reporting 115 drug shortages. Additionally, we began a market search for new 503B vendors that could meet both our portfolio and volume requirements. Learn on-demand, earn credit, find products and solutions. 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. 1. Semi-structured interviews were performed to … Twitter: @JELagasse 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. Stacey B. Pattie, PharmD, BCPS, is a medication use policy pharmacy coordinator for the UVA Health System. When these issues arise, key physician stakeholders in the respective areas are engaged to provide clinical guidance and help determine a management plan. Call : 1-877-258-5465 Industry 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. But how she knows that is a whole other story. Should a drug shortage create an ethical dilemma regarding allocation or rationing of drug supply, the physician champions enlist the Ethics Committee for guidance. 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. Methods Medline, Embase, Global Health, PsycINFO and International Pharmaceutical Abstracts were searched using … Return to FDA Drug Info Rounds Page. 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