Pharmacy & Therapeutics - March 2008 - (Page 128) MEDICATION ERRORS Evidence-Based Medicine Doesn’t Preclude Common Sense Matthew Grissinger, RPh, FASCP Mr. Grissinger is Director of Error Reporting Programs at the Institute for Safe Medication Practices in Huntingdon Valley, PA (www.ismp. org). If you went skydiving, would you first ask for scientific evidence from a randomized trial that a properly functioning parachute prevents injury before you’d consider using one during your freefall? Probably not. In fact, no such study exists.1 Of course, some people without a parachute have survived a freefall from extraordinary heights without injury, and others have sustained injuries even when using a parachute. But it’s clear that you’d use a parachute when skydiving, even without a single randomized trial to prove its effectiveness. Yet, when it comes to medicine, clinicians may be reluctant to employ any intervention without rigorous scientific evidence for its efficacy. The need for sound evidence evolved from a history of medicine that’s littered with practices that were later abandoned after scientific scrutiny showed that they were ineffective, perhaps even harmful.2 As such, we are among the many who would agree with the general concept of “evidence-based medicine.” However, when it comes to patient safety, there are significant obstacles to this approach. might focus on less important safety concerns than those that are problematic in your organization. were required in processes, equipment, organizational leadership, education, and teamwork—not one of which has had a clear-cut impact on mortality. Rather, safety was achieved by applying a host of changes that (1) were based on an understanding of principles involving human factors as well as on a clear link between certain processes and observed adverse events (e.g., an anesthesiologist giving medications), (2) were learned from safety practices in other industries, and (3) made sense, considering the potential risks and benefits of the interventions.2 These criteria, then—common sense, principles involving human factors, a linkage between processes and adverse events, and lessons learned from safety practices in other industries—should not be given short shrift in favor of evidencebased interventions alone. In fact, it would be tragic to abandon safety initiatives such as pharmacy intravenous admixture systems and computer-generated medication administration records (MARs) simply because they are not backed by scientific evidence. And to await irrefutable proof of effectiveness is simply not an option. We must make informed decisions based on the best available information and common sense. FEASIBILITY Obvious difficulties involving ethics and recruitment preclude a randomized trial of a parachute’s effectiveness; similar problems exist for some patient safety interventions. After all, who would allow themselves or their family member to be randomly assigned to a control group—be it freefalling without a parachute or being the recipient of a prescription using an abbreviation like “U” for units, each with anecdotal evidence of causing harm. Moreover, an institutional review board would never approve either study. The incredibly large scope of a study that could prove efficacy might also be a limiting factor. For example, let’s consider the practice of requiring a leading zero for doses of less than one (e.g., 0.10).2 Perhaps only one in 100 clinicians would misread the dose as a whole number (10) if the leading zero were omitted. Maybe one in five such errors (20%) would affect the patient and 1 in 10 errors (10%) would cause significant harm. It would be incredibly difficult to carry out a controlled study of suf ficient size to prove that patient harm is reduced when leading zeros are used. More to the point, is such a large and costly study needed if experience tells us that leading zeros reduce the risk of errors, some of which have caused significant patient harm? REFERENCES 1. Smith CS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: A systematic review of randomized control trials. BMJ 2003;327: 1459–1461. 2. Leape LL, Berwick MB, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA 2002;288:501–507. LIMITED RESEARCH ON PATIENT SAFETY Error prevention is still a new field that has attracted just a fraction of the funding provided in medical research performed today. Thus, you’d be likely to find rigorous scientific evidence related to clinical interventions, drugs, and devices used to prevent complications from care that are not associated with errors. But many obvious error-reduction strategies are noticeably absent in current research. Conversely, if you applied only evidence-based interventions to ensure safety, you could end up with an ineffectual program that A MORE BALANCED APPROACH In the end, a traditional evidence-based approach cannot be our only source of promoting patient safety. The safe administration of anesthesia is a good example.2 Although mortality rates during elective anesthesia have declined by 10-fold in the past few decades, this achievement was not driven by meticulous scientific evidence that certain practices reduced mortality. The reduction was not attributable to any single practice, new drug, or technology. Instead, a broad array of changes The reports described in this column were received through the USP–ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP (www.ismp. org) or the USP (www.usp.org) Web site or communicated directly to ISMP by calling 1-800-FAILSAFE or via e-mail at ismpinfo@ismp.org. I 128 P&T® • March 2008 • Vol. 33 No. 3 http://www.usp.org
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