Comparing Drug Shortages Experienced by Institutions With National Metrics.

Drug shortages have increasingly posed challenges to providers, pharmacists, and patients for more than 20 years. Regardless of the underlying causes, for which there does not appear to be a solution in sight, healthcare providers and patients must deal with the consequences. There is often conflicting and confusing information published that confuses everyone. This article describes the reasons for conflicting information from different sources.

Drug shortage management: A qualitative assessment of a collaborative approach.

Drug shortages frequently and persistently affect healthcare institutions, posing formidable financial, logistical, and ethical challenges. Despite plentiful evidence characterizing the impact of drug shortages, there is a remarkable dearth of data describing current shortage management practices. Hospitals within the same state or region may not only take different approaches to shortages but may be unaware of shortages proximate facilities are facing. Our goal is to explore how hospitals in Michigan handle drug shortages to assess potential need for comprehensive drug shortage management resources. We conducted semi-structured interviews with diverse stakeholders throughout the state to describe experiences managing drug shortages, approaches to recent shortages, openness to inter-institutional engagement, ideas for a shared resource, and potential obstacles to implementation. To solicit additional feedback on ideas for a shared resource gathered from the interviews, we held focus groups with pharmacists, physicians, ethicists, and community representatives. Among participants representing a heterogeneous sample of institutions, three themes were consistent: (1) numerous drug shortage strategies occurring simultaneously; (2) inadequate resources and lead time to proactively manage shortages; and (3) interest in, but varied attitudes toward, a collaborative approach. These data provide insight to help develop and test a shared drug shortage management resource for enhancing fair allocation of scarce drugs. A shared resource may help institutions adopt accepted best practices and more efficiently access or share finite resources in times of shortage.

A compounding compliance team at an academic medical center.

PURPOSE: Highly publicized safety issues arising from poor sterile compounding practices in facilities around the United States have garnered substantial attention in recent years. This attention has led to increased scrutiny of health systems by regulatory bodies, new regulatory requirements, and changes to existing regulations or their interpretation. Health systems are often resource constrained, and the added work resulting from this scrutiny challenges pharmacy departments in meeting regulatory requirements and United States Pharmacopeia chapter 797 standards for sterile compounding. This article describes the creation of a dedicated compounding compliance team (CCT) and the team's responsibilities in support of pharmacy operations in achieving compliance with those standards. SUMMARY: Visits to our organization by several regulatory bodies resulted in findings that required substantial work in order to achieve compliance with sterile compounding standards. Given the number and complexity of findings and the need for timely resolution, it was felt that specialized staff were needed to understand, evaluate, and correct identified deficiencies and help the already overburdened staff and leadership comply with existing standards. A CCT was formed, and work was simultaneously initiated on ensuring proper credentialing and training of all compounding staff, development of standard operating procedures, improvements in facilities, environmental monitoring, equipment certifications, practice auditing, and documentation. Key activities of the team included strategic planning, building relationships, communicating with stakeholders, self-education, and record keeping. Key partners included environmental services, facilities, and infection prevention and control personnel and departmental staff and leaders. CONCLUSION: The formation and collaborative work of a CCT at an academic medical center was successful in changing the culture of the organization and achieving compliance during visits from several regulatory agencies.