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To the Editor: Rose and Curry1 incorrectly portrayed the randomized controlled study of the efficacy of armodafinil in shift work disorder2 published in the November 2009 issue of Mayo Clinic Proceedings as testing a pharmaceutical alternative to the work-hour restrictions for resident physicians recommended by the Institute of Medicine.3 Wake-promoting therapeutic medications are an inappropriate alternative to implementation of safer work schedules for resident physicians or other employees. Moreover, our study data did not, as they wrote, “suggest that pharmaceutical agents may be used safely to counteract the effects of fatigue from prolonged [resident physician] work shifts…to preserve and/or enhance the continuity experience without sacrificing the quality of care.” In fact, employees who worked shifts in excess of 12 consecutive hours (which included resident physicians working 30-hour shifts) were excluded from participation in the study.
The study did not compare the effect of work-hour restrictions with the use of a drug to enhance performance, nor did it evaluate their referenced use of stimulants by the military. Instead, the study was designed to evaluate the efficacy of armodafinil compared with placebo in patients with chronic shift work disorder of moderate or greater severity. It was recommended that a comprehensive approach for patients with shift work disorder “should address sleep and wake hygiene, strategic napping, appropriate time off between work periods, diet, exercise, appropriately timed light exposure to facilitate circadian adaptation, and work hour limits” (emphasis added). As recommended by the Sleep Deprivation and Stimulant Task Force of the American Academy of Sleep Medicine,4 the most appropriate treatment for excessive sleepiness in individuals whose sleep-wake schedules do not allow sufficient time for sleep (such as resident physicians) is to modify their schedule to allow an adequate amount of time for sleep; voluntary judicious use of a controlled substance, such as armodafinil, should be administered only under appropriate medical supervision and reserved for excessive sleepiness associated with medical conditions, such as narcolepsy and shift work disorder, and “for those for whom sleep loss is inevitable (eg, in emergencies when public health and safety personnel are responding to a disaster or when military personnel must engage in prolonged operations).” The 120-year-old tradition in the United States of routinely scheduling resident physicians to work extended duration shifts does not constitute such an emergency.
Postgraduate training of physicians has been proceeding successfully in New Zealand since 1985 with a 16-hour shift duration limit and, more recently, in the European Union with a 13-hour shift duration limit, undermining the premise that working 30-hour shifts twice per week, as sanctioned in the United States by the Accreditation Council of Graduate Medical Education (ACGME), is a necessary component of postgraduate medical education. To the contrary, the Institute of Medicine concluded that working more than 16 consecutive hours without sleep is unsafe both for patients and for resident physicians themselves. As I noted recently,5 it is time to implement safer work-hour limits for resident physicians, as has been done in other safety-sensitive industries and in residency training in many other countries, as well as in a growing number of residency programs in the United States.