Pharmacy & Therapeutics - March 2009 - (Page 123) PRESCRIPTION: WASHINGTON guidance had said that article reprints should be based on “adequate and wellcontrolled clinical investigations that are considered scientifically sound by experts with scientific training and experience to evaluate the safety or effectiveness of the drug or device.” This is the standard that the FDA has established for clinical trial studies submitted in support of an NDA. “There are many types of clinically valuable scientific reporting, including case studies, meta-analyses, and observational studies, which may not qualify as ‘adequate and well-controlled’ under FDA’s regulations,” PhRMA argued. In the final guidance, the FDA keeps the “adequate and well controlled” language but genuflects toward the industry. The FDA explains that this research can include historically controlled trials, pharmacokinetic and pharmacodynamic studies, and meta-analyses if the companies are testing a specific clinical hypothesis. ASHP’s Dr. Donegan argues that she would not consider historically controlled, pharmacokinetic, and pharmacodynamic studies to be high-quality clinical investigations. Moreover, the term “adequate and well-controlled clinical investigations” is too subjective for her. “We wish the FDA [had] defined that much better,” she states. I EDITORIAL continued from page 119 MEDICATION ERRORS continued from page 120 COMING SOON TO P&T EDITORIAL: R&D Redux David B. Nash, MD, MBA DRUG FORECAST: Nebivolol (Bystolic): A Novel Beta Blocker for Hypertension Olga Hilas, PharmD, BCPS, CGP CE/CME CREDIT: Spontaneous Bacterial Peritonitis Cesar Alaniz, PharmD, and Randolph E. Regal, PharmD FEATURE ARTICLE: Pharmacoeconomic Analysis of Micafungin in the Treatment of Candidemia Kwaku Marfo, PharmD, and Yi Guo, PharmD coordinate medical care within an episode of care and to limit duplication of services, thereby creating a strong incentive to improve the quality of health care and eliminate errors. Is this all too good to be true or even too complicated to implement? I don’t think that this model is any more complex than other current insurance models. I think that ECRs could have a large impact on P&T committee members; ECRs can be considered as a type of global fee that might or might not include total pharmaceutical costs. In experiments in which ECRs include pharmaceutical costs, we must take care in how we make use of high-end products. Who gets to write the prescription for the monoclonal antibody, the biologic agent, or the clot-buster or related product at $7,000 per dose? In summary, not all P&T committee members will embrace the Prometheus Payment model, ECRs, or the like, but I believe that it is in our best interest to monitor these developments in the marketplace. At least one P&T committee member in each organization ought to be fluent in this language. We can anticipate more national experiments with ECRs in the near future. If you are currently using an ECR or any form of global episodebased payment, please let me know and I will spread the word about the challenges and the rewards. Readers can learn more about Prometheus Payment by visiting the Web site, www.prometheuspayment.org. As always, I’m interested in your views. My e-mail address is david.nash@ jefferson.edu. Please also visit my blog at http://nashonhealthpolicy.blogspot.com. levels of ambient light may help reduce the effects of disrupted circadian rhythms for workers on the night shift. Special facilities may be needed to allow workers to obtain light therapy at designated times, although timing is crucial to its success. 6. Evidence-based safety practices. Although not a replacement for a wellrested health care team, proven safety practices (e.g., computerized prescriber order entry, bar coding, smart pumps) may help reduce the incidence of errors caused by impairment from fatigue. Fatigue might never be fully remedied in a health care industry that must provide 24 hours of continuous care every day, but it can be better managed. Nevertheless, human errors will still happen. The best solution probably requires a systems approach that both limits the causes of fatigue in the workforce and reduces the potential for human error. REFERENCES 1. Gillberg M, Kecklund G, Akerstedt T. Relations between per formance and subjective ratings of sleepiness during a night awake. Sleep1994;17(3):236–241. 2. Linde L, Bergstrom M. The effect of one night without sleep on problem-solving and immediate recall. Psychol Res 1992; 54(2):127–136. 3. Howard S. Fatigue and the practice of medicine. Anes Patient Saf Found Newsletter 2005;20(1):1–4. 4. Dawson D, Reid K. Fatigue, alcohol and performance impairment. Nature 1997; 388:235. 5. Rosekind MR, Gander PH, Connell LJ, et al. Crew factors in flight operations X: Alertness management in flight operations. National Aeronautics Space Administration (NASA) Technical Memorandum No. 1999-208780. Moffett Field, CA: NASA; 1999. 6. Howard SK, Gaba DM, Smith BE, et al. Simulation study of rested versus sleep deprived anesthesiologists. Anesthesiology 2003;98:1345–1355; discussion A. 7. Institute of Medicine. Keeping Patients Safe: Transforming the Work Environment of Nurses. Washington, DC: National Academy Press; 2004. REFERENCE 1. de Brantes F, Rastogi A. EvidenceInformed Case Rates: Paying for Safer, More Reliable Care. New York: The Commonwealth Fund; June 2008;40:1–13. Available at: www.commonwealthfund. org. I The reports described in this column were received through the ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP Web site (www.ismp. org) or communicated directly to ISMP by calling 1-800-FAILSAFE or via e-mail at ismpinfo@ismp.org. I Vol. 34 No. 3 • March 2009 • P&T® 123 http://www.prometheuspayment.org http://nashonhealthpolicy.blogspot.com http://www.commonwealthfund.org http://www.commonwealthfund.org http://www.ismp.org http://www.ismp.org
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