Implementation of a formulary management process.

PURPOSE: The application of lean methodology in an initiative to redesign the formulary maintenance process at an academic medical center is described. SUMMARY: Maintaining a hospital formulary requires clear communication and coordination among multiple members of the pharmacy department. Using principles of lean methodology, pharmacy department personnel within a multihospital health system launched a multifaceted initiative to optimize formulary management systemwide. The ongoing initiative began with creation of a formulary maintenance redesign committee consisting of pharmacy department personnel with expertise in informatics, automation, purchasing, drug information, and clinical pharmacy services. The committee met regularly and used lean methodology to design a standardized process for management of formulary additions and deletions and changes to medications' formulary status. Through value stream analysis, opportunities for process and performance improvement were identified; staff suggestions on process streamlining were gathered during a series of departmental kaizen events. A standardized template for development and dissemination of monographs associated with formulary additions and status changes was created. In addition, a shared Web-based checklist was developed to facilitate information sharing and timely initiation and completion of tasks involved in formulary status changes, and a permanent formulary maintenance committee was established to monitor and refine the formulary management process. CONCLUSION: A clearly defined, standardized process within the pharmacy department was developed for tracking necessary steps in enacting formulary changes to encourage safe and efficient workflow.

Menopausal hormone therapy (MHT): refining our understanding of MHT research, optimally applying results, and considering the future of MHT.

The perceptions of menopausal hormone therapy (MHT) have evolved considerably. Observational studies suggested that MHT could relieve vasomotor symptoms and prevent coronary heart disease (CHD). However, randomized controlled trials later showed no reduction in CHD and an increased risk of stroke. Subsequent analyses of these trials have shown that in women younger and closer to menopause, the risks associated with MHT may not be as great as originally thought. Several organizations, including the North American Menopause Society, the International Menopause Society, and the Endocrine Society, have published guidelines and statements that help health care providers translate the research findings into clinical practice. A common theme from these organizations is the need for health care providers to tailor information to their patients so they may make informed treatment decisions (especially considering the media attention MHT has received). It is particularly important to individualize therapy, considering patients' risk factors for atherosclerotic disease, venous thromboembolic disease, osteoporosis, and breast cancer. Ongoing research in women younger than those in prior trials is evaluating lower doses of MHT and directly comparing transdermal and oral formulations. Such research should help define the population of women most likely to benefit from MHT without undue risk of adverse outcomes.

Formulation of buprenorphine for sublingual use in neonates.

OBJECTIVES: The only medication used sublingually in the neonate is buprenorphine for the treatment of neonatal abstinence syndrome (NAS). Compared with morphine, buprenorphine reduces the length of treatment and length of hospitalization in neonates treated for NAS. The objective of this study was to characterize the stability of ethanolic buprenorphine for sublingual administration. METHODS: Buprenorphine solution was prepared and stored in amber glass source bottles at either 68°F to 77°F (20°C-25°C) or 36°F to 46°F (2.2°C-7.8°C). Samples were collected from each of these batches on days 0, 3, 7, 14, and 30. Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days. Buprenorphine concentration was assessed by liquid chromatography-electrospray ionization-tandem mass spectrometry. RESULTS: Neither storage temperature (p=0.65) nor storage time (p=0.24) significantly affected buprenorphine concentrations. All of the mean concentrations, regardless of storage temperature, were above 95% of the labeled concentration, and the potency was maintained for samples stored either in the original amber glass source bottles or in oral syringes. CONCLUSIONS: An ethanolic buprenorphine solution is stable at room temperature for 30 days.