Book Review

Preventing Medication Errors

Medication Errors

N Engl J Med 2007; 357:624-625August 9, 2007

Article

Preventing Medication Errors
(Quality Chasm Series.) By the Committee on Identifying and Preventing Medication Errors and the Board on Health Care Services. Edited by Philip Aspden, Julie A. Wolcott, J. Lyle Bootman, and Linda R. Cronenwett. 463 pp. Washington, DC, National Academies Press, 2007. $54.95. ISBN: 978-0-309-10147-9

Medication Errors
Second edition. Edited by Michael R. Cohen. 680 pp., illustrated. Washington, DC, American Pharmacists Association, 2007. $89.95. ISBN: 978-1-58212-092-8

Health care is inherently risky, and filling a handwritten prescription could be the most dangerous of all medical procedures. Medication errors, which are often caused by illegible handwriting, are a subgroup of medical errors and may cause as many as 7000 of the 98,000 deaths in the United States each year that the Institute of Medicine (IOM) attributes to medical errors. Now the IOM, in its new report in the Quality Chasm Series, Preventing Medication Errors, estimates that in the United States, the average hospital patient is subject to at least one medication error per day and that each year more than 1.5 million patients have injuries resulting from preventable adverse drug events. The new study covers the development of an evidence-based review of drug safety as well as guidelines for policymakers and government agencies.

The IOM authorship committee (disclosure: two of its members are employees of Intermountain Healthcare) has clearly fulfilled its charge concerning prescription and over-the-counter drugs and complementary and alternative medications. However, the book has little practical advice for clinicians. Indeed, the major purpose of the committee was to recommend agendas for consumers, health care organizations, and the industries and regulatory agencies involved with drugs, medical devices, and health care information technology. I was surprised that the evidence for the most highly touted prevention strategies, such as computerized provider order entry, computer-based decision support systems, smart pumps, and bar coding, was reviewed only in the last appendix.

The second edition of the book Medication Errors, edited by Michael R. Cohen, takes up where the IOM report leaves off and complements it with detailed information that is useful for clinicians and clinical pharmacists. A pharmacist and the president of the nonprofit Institute for Safe Medication Practices (ISMP), Cohen has been a voice crying out in the wilderness for three decades and was a 2005 recipient of a John D. and Catherine T. MacArthur Foundation “genius grant.” Cohen is coeditor of a widely read periodical published by the ISMP that focuses on “high-alert medications” and recent problems with particular drugs. He devised a method that uses “tall man” lettering to prevent errors in the use of drugs with look-alike, sound-alike names, and he also created a voluntary system for reporting errors, now called the United States Pharmacopeia–ISMP Medication Errors Reporting Program. Cohen's ISMP proficiency tests have shown the inability of many pharmacy computer systems to detect unsafe and potentially fatal medication orders and have been an important impetus for the design of safer systems.

Cohen defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.” This definition includes errors at any stage of medication use and not just during the process of drug administration. Cohen believes that the “five rights” of safe medication use (the right patient, right drug, right time, right dose, and right route of administration) place too much focus on individual performance and overlook the systemic problems that underlie the human errors. He emphasizes that “finding out who was involved is less important than learning what went wrong, how, and why.”

The IOM report represents, so far as possible, a consensus of the committee and looks toward fundamental reforms in the health care system, including the pharmaceutical industries and regulatory agencies. In addition to systemic reforms, its authors mention some of the things that individual physicians, nurses, pharmacists, and caregivers can do to prevent errors. Cohen's book, on the other hand, contains chapters by authorities from a variety of disciplines, several of whom — including Cohen — also contributed to the IOM report. Cohen's book better describes specific medication errors and how to prevent them. The centerpiece is an excellent chapter on “high-alert medications,” which Cohen defines as drugs with a high risk of causing patient injury or death if they are misused; the chapter includes a comprehensive table of safety measures for various drug classes. Many physicians who trained in the old days will be surprised to learn that there are good reasons for using trade names as well as generic names when prescribing certain medications, such as lipid-based amphotericin B products.

Both books call for the elimination of handwritten prescriptions and for the use of electronic decision-support systems by prescribers and pharmacies by the year 2010. Yet the authors of both books also recognize that electronic prescribing is not a panacea. The IOM committee also calls for a gradual shift of the research agenda from defining incidence rates to prevention strategies and suggests a starting budget of $50 million to $100 million to fund these studies through the federal Agency for Healthcare Research and Quality. However, the committee does not further explain its rationale.

Example of a Potentially Fatal Computerized Order-Entry Error Intercepted by a Pharmacist.

Medication errors are a complex epidemiologic problem as well as a quality problem, and those who study such errors are saddled with a profusion of poorly defined concepts, such as “near miss,” “intercepted error,” and “potential adverse drug events.” The focus on errors has been useful because it draws attention to preventability. However, the definitions that have been used for various types of errors and adverse events vary widely, and the IOM committee calls for an international consensus conference to define terms. This effort is analogous to the methods used by intensivists to define the sepsis syndrome. Most medication errors, such as a missed dose, do not cause harm to patients, and conversely, most adverse drug events are not due to mistakes. In addition, certain types of adverse drug events that once were considered nonpreventable can now be ameliorated by intensive monitoring and early recognition — or even prevented entirely. For example, the failure to adjust the dose of a nephrotoxic antibiotic when a patient's renal function declines would probably not precipitate an incident report to the voluntary reporting systems in most hospitals. Yet the number of these errors can be reduced with the help of computer-based decision-support systems and electronic health records.

Both of these books provide reviews of methods that are purported to increase drug safety, such as improved drug naming, labeling, and packaging; analysis of the root causes of important adverse drug events; failure mode and effects analysis of the processes of medication use; and voluntary reporting of important adverse events. The book by Cohen describes all these methods in greater depth than the IOM committee does. It also includes chapters that discuss how to disclose errors to patients and accounts of some of the emotional experiences of providers who have made fatal errors involving medication.

These books with similar titles are authoritative, thorough, and well written. Both aim to improve drug safety and together represent the most up-to-date and broadest coverage of the subject now available. Both these books are fact-filled and visionary, but unfortunately, the benefits of many of the drug safety measures could have been better assessed and measured in the clinical setting. Nonetheless, the books might provoke varied responses from readers: frustration or despair because of the enormous gulf between what we do and what we know, admiration of what has been accomplished, and hope for the future.

John P. Burke, M.D.
LDS Hospital, Salt Lake City, UT 84103
john.burke@intermountainmail.org