IOM Report Takes on Medication Errors . . . Again

In its latest report on medication errors, a committee assembled by the Institute of Medicine (IOM) included some sidebars on psychiatric drugs. The report, issued in July, said that there is too little data on misadministration of psychiatric drugs and that clinical trials with psychiatric drugs have been "small and incapable of providing pragmatic, comparative information."

The report is a follow-up to a 2000 IOM report called To Err is Human, which speculated that there may be as many as 98,000 deaths a year in hospitals caused by patients getting the wrong medication or the wrong dosage. This latest report underlined the fact that while some progress has been made, much more needs to be done. "The frequency of medication errors and preventable adverse drug events is cause for serious concern," said committee co-chair Linda R. Cronenwett, dean and professor at the University of North Carolina at Chapel Hill School of Nursing.

One of the problems highlighted by the report is the confusion caused when 2 drugs have similar-looking and sounding names. The IOM report doesn't use this example, but the current STAR*D depression study, the largest ever of its kind, offers patients a choice of sustained-release bupropion (Wellbutrin) or buspirone (BuSpar) in one section of the trial. Of course, both are psychiatric drugs, but they do have different actions and adverse-effects profiles.

The new IOM report, released in July, focused on all drugs, not just those for depression, psychosis, and other psychiatric conditions. The report notes that psychiatrists' professional organizations "have only recently identified medication errors as a patient safety and quality concern." The APA created the Committee on Patient Safety in 2003. The report said that psychiatrists and other mental health professionals should join with others outside their discipline to "speak a common language regarding the detection, reporting, and management of medication errors and avoidable drug errors. Broader incorporation of such terminology might also enable a more objective comparison of quality among psychiatric hospitals."

Issues concerning clinical trials

Even though they would seem to be outside the issue of medication errors, clinical trials--in the IOM committee's view--play an important role in that they generate the data upon which dosing and administration policies are based. "Recent studies funded by the National Institute of Mental Health have fueled concern about the basic knowledge base for treatment of depression, manic-depressive illness, and schizophrenia," the report said.

Pharmaceutical Research and Manufacturers of America (PhRMA), the drug manufacturers' trade group, has recommended that its members voluntarily register all of their clinical trials on the Web site www.clinicaltrials. gov, which is run by the National Library of Medicine, part of the NIH. Currently, companies only have to enter results of clinical trials for serious and life-threatening conditions, and only for Phase I, II, and select stage IV trials. The IOM report calls that situation "inadequate to support safety and quality in medication use." It recommends a single national registry populated with information generated through clinical studies of all drug products, which, it says would be a "critically important resource for all stakeholders in the medication-use system."

Alan Goldhammer, associate vice president of PhRMA, commenting on the IOM report, said the judgment that published clinical trial results are inadequate to support safe medication use was "plain wrong," adding that "that is what the drug label is supposed to do."