FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply.

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.

US Food and Drug Administration Disruption of Generic Drug Market Increases Hospital Costs.

BACKGROUND: The purpose of the US Food and Drug Administration's Marketed Unapproved Drugs Initiative is to decrease marketing of older unapproved medications. The administration has recently extended its rulings by including sterile injectable drugs administered in the inpatient environment. The impact of this initiative on the inpatient environment has been minimally studied. METHODS: Consecutive retrospective purchase data of vasopressin for injection (vasopressin) and neostigmine methylsulfate for injection (neostigmine) from 720 hospitals and 746 hospitals, respectively, were included. Purchases occurred from January 1, 2010 to December 31, 2016. The average noncontract drug price was calculated and compared to the purchase data during the impact of the initiative. Comparison was made of hospital purchases made before and after the initiative. The year 2014 was considered a washout transition year due to the large amounts of discontinued unapproved formulations that were still available and purchased by hospitals. The analysis was completed using a matched paired t test. RESULTS: The noncontract price for vasopressin increased from $12.83 per vial to $158.83 per vial (1138% increase) and for neostigmine from $27.74 per vial to $175.14 per vial (531% increase) across the pre- and postinitiative intervals; however, purchase volumes after the price increases were not found to have a statistically significant difference compared to purchases before the price increases (P = .98 and P = .4, respectively). CONCLUSIONS: Health systems have experienced a significant cost increase of vasopressin and neostigmine and are absorbing price increases for these older, generic sterile injectable drugs.

Supply chain optimization at an academic medical center.

PURPOSE: A successful supply chain optimization project that leveraged technology, engineering principles, and a technician workflow redesign in the setting of a growing health system is described. SUMMARY: With continued rises in medication costs, medication inventory management is increasingly important. Proper management of central pharmacy inventory and floor-stock inventory in automated dispensing cabinets (ADCs) can be challenging. In an effort to improve control of inventory costs in the central pharmacy of a large academic medical center, the pharmacy department implemented a supply chain optimization project in collaboration with the medical center's inhouse team of experts on process improvement and industrial engineering. The project had 2 main components: (1) upgrading and reconfiguring carousel technology within an expanded central pharmacy footprint to generate accurate floor-stock inventory replenishment reports, which resulted in efficiencies within the medication-use system, and (2) implementing a technician workflow redesign and algorithm to right-size the ADC inventory, which decreased inventory stockouts (i.e., incidents of depletion of medication stock) and improved ADC user satisfaction. CONCLUSION: Through a multifaceted approach to inventory management, the number of stockouts per month was decreased and ADC inventory was optimized, resulting in a one-time inventory cost savings of $220,500.