Investigation of JCAHO may tighten standards

OIG wants better curbs on medication errors

With the federal investigation of the Joint Commission on the Accreditation of Healthcare Organizations’ oversight of hospitals, reporting and prevention of medication errors are being ratcheted up to new levels. The investigation, conducted by the Department of Health and Human Service’s (HHS) Office of the Inspector General (OIG), could lead to new standards for physicians, nurses, and hospital pharmacists and more accountability for medication errors.

Whereas most reporting occurs through the U.S. Pharmacopoeia’s (USP) voluntary Medication Errors Reporting program, the OIG probe could mean HHS is considering greater federal oversight. Among other things, OIG officials will analyze "trend data on the most recent deficiencies and survey scores," as well as "information about recent significant adverse events in hospitals and responses to them," according to an 11-page memorandum sent June 20 to Joint Commission president Dennis O’Leary.

The federal inspection comes at a time when private and professional health care groups already are working hard to curb medication errors and assure patients that the drugs they receive are safe, despite a growing number of highly publicized cases in which patients died from improperly filled or administered medications. The National Council for Medication Error Reporting and Prevention has launched a major education campaign targeting potentially dangerous pitfalls in writing and filling prescriptions. The program is based on the council’s first set of recommendations on safe prescription writing practices and consists largely of informational mailings to hospital pharmacists and administrators.

Since the USP established its Medication Errors Reporting program in 1991, just under 3,000 reports of medication errors have been submitted by health care practitioners. While the total number of incidents is unknown, Diane DeMichele Cousins, RPh, who heads the USP reporting program, estimates that 1,500 to 2,000 hospitals may participate in the program. Reports made to USP are confidential, though information is shared with the manufacturer, the U.S. Food and Drug Administration, and the Institute for Safe Medication Practices (ISMP) in Warminster, PA. ISMP first developed a medication error reporting program for local hospitals in the late 1970s, later turning it over to USP to expand nationally.

The USP program has revealed a plethora of problems underlying medication errors, including understaffing, poor product labeling, poorly or incompletely trained staff, fatigue, poor communication, and system failures. Of reported incidents, 5% have resulted in patient deaths. (See related story on admixture errors, p. 123.)

Pharmacists in ambulatory settings -– such as community and chain pharmacies -– often face serious staff shortages and time constraints that can contribute to errors in filling medication orders, says Bill Ellis, director of the Quality Center at the American Pharmaceutical Association (APhA) in Washington, DC. "It’s not uncommon for pharmacists, with very little help, maybe a technician, to be filling 200, 300, 400 prescriptions a day," he points out. He says APhA is seeking to fund a study, in conjunction with the National Boards of Pharmacy, to study the relationship between medication errors and environmental factors and workflow in ambulatory settings.

Workload also hinders reporting of medication errors, which is lower among ambulatory providers than hospitals. Ideally, Cousins says she would like to see increased participation in the reporting program by community and retail pharmacies, long-term care facilities, and emergency medical services.

Henri Manassee Jr., executive vice president of the American Society of Health-System Pharmacists in Bethesda, MD, maintains that better checks are needed to prevent medication errors from repeating. "We’ve got to figure out better ways to make [the system] fail-safe," he asserts. "I’m amazed, for example, that with all the fatalities associated with concentrated potassium chloride, how many institutions still keep that concentrated [drug] as part of their stocks, rather than safeguarding it and having special procedures to even have access to it."

Last summer, the council issued a medication error index to assist pharmacists in tracking errors in a consistent, systematic manner by rating them according to the severity of outcome.

Future efforts will focus on packaging, labeling, and product identity. Use of similar drug names plays a major contributing role in medication errors and can occur because of poor handwriting, lack of knowledge about the product, or regional dialects. Roughly 25% of errors reported to USP are due to confusion about product names. Ellis said manufacturer groups, on the whole, have been willing to alter packaging or labeling to help reduce the incidence of errors.

Meanwhile, the USP Advisory Panel on Medication Errors is working on recommendations for the use of neuromuscular blockers. The agents, when used without assisted-breathing mechanisms, have resulted in patient deaths.

Even this is not enough, according to the OIG, which has decided the number of catastrophic events in hospitals is too high and questions the effectiveness of the Joint Commission’s oversight of quality control. According to the memorandum, the OIG is "seeking a deeper understanding of the current system of oversight for hospitals participating in Medicare . . . [at a time when] patient harm in hospitals has become a frequent headline, calling into question the current system of oversight."

As part of its inquiry, OIG investigators are accompanying the Joint Commission on at least four accreditation surveys between July and October of this year. At least one of those will involve a hospital that is part of a hospital system, the agency has reported. There is no indication of how many hospitals the OIG may actually visit, but hospital pharmacists could well expect their next survey to be one in which the standards are strictly interpreted.

ISMP president Michael Cohen welcomed the OIG investigation, saying it is "important to make sure that there’s some process in place to make sure that we don’t see repeat errors. The same things shouldn’t happen again and again."

Cohen has criticized the accrediting group for micromanaging hospitals and failing to convey medical error information derived from one hospital to other facilities. He cited the case of a child who went into cardiac arrest and died in a hospital operating room when doctors inadvertently administered adrenaline instead of anesthesia. The labeling procedures and availability of adrenaline in a 30 ml vial allows for misuse, such as accidentally pouring it into the wrong pan. "There are 6,000 hospitals out there that are doing the identical thing that caused this kid’s death," Cohen declares, adding that he has "personally" seen it at many hospitals.

"We have to have inspectors go in and say, I’d like to see what procedure you use in the OR to ensure that the proper solutions are used and the basins that you use are properly labeled, because there was a death in another hospital . . . It should be on every checklist for every survey," he says.

"JCAHO is certainly in a position to do a lot of good with the survey process . . . [but] they need to react to events that occur and then make sure that they don’t occur again, and they’re not doing that," Cohen maintains.

Pressure on the voluntary program to step up performance and results is coming from several directions. In addition to the OIG’s inspection of the Joint Commission, Rep. William Coyne (D-PA) introduced legislation this spring to require health facilities to report deaths from drug foul-ups. The bill HR 524, or the Safe Medications Act of 1997 would impose a $15,000 fine for each unreported death and exclude those facilities convicted of failing to report from receiving Medicare and state health care payments.

While the bill is given little chance of passing this session unless it is folded into other legislation, it was viewed by those monitoring the issue as a wake-up call for health professionals to take responsibility and participate more fully in the USP’s voluntary program.

Professional groups and the USP are reluctant to see the voluntary program give way to a mandatory, punitive reporting system. Moreover, Cousins believes the Coyne proposal misses the mark by focusing on medication-related deaths. "We should also be working to reduce the errors of lesser severity, right down to potential errors," she tells Drug Utilization Review. "We find that some of the information that we receive on potential errors is so valuable, because it tells you what could happen without resulting in serious outcome for the patient. That’s something you could never successfully mandate."

Privacy also is an issue in medication error reporting. Cousins says many pharmacists wait until they leave their facility to file reports because of risk-management issues and lack of support from hospital managers. In light of the pending legislation, she says USP will seek legislation to make the reporting of medication errors privileged information that would not be subject to subpoenas. Clearly, the heat is on health professionals to reduce the incidence of medication errors through stepped-up reporting and corrective action that will prevent them from occurring in the first place. But it remains to be seen if the health care industry will make the necessary changes on its own, or if the needed improvements will require some government muscle.