Glut of medication errors focuses pharmacists on event reporting
Tumultuous year ending with positive steps
Late last year, Long Branch, NJ-based Monmouth Medical Center was hit with a $12 million lawsuit and fines from the New Jersey state board after a medication error killed a 10-month-old infant. The child, who was being treated for liver cancer, died after receiving 204 mg of a chemotherapy agency instead of the correct dose of 20.4.
An investigation found that the prescribing physician left out the decimal point, and nurses administered the dose without question. So far, the hospital has responded to the charges against it by firing one employ ee. That’s just one of many recent examples of serious medication errors that have prompted national regulatory agencies like the Oak brook Ter race, IL-based Joint Commission on Accred itation of Health care Org anizations (JCAHO) to take a hard look at adverse event reporting systems and a host of other related issues.
This year alone, high-profile recalls of drugs like fenfluramine, Posicor, and Duract put drug makers in the hot seat. Physicians felt the heat, too, when the U.S. Food and Drug Administration in July found itself defending a decision not to pull the diabetic drug Rezulin off the market. Citing the unique benefits Rezulin provides Type II diabetics, the agency claimed that reports of liver failures associated with the drug had more to do with the failure of physicians to properly monitor patients and heed label warnings than the drug’s potential for adverse effects.
Meanwhile, the April approval of Viagra led to record numbers of prescriptions and then questions about the drug’s safety, fueling the fire over fast-track approval mandates included in the FDA overhaul bill earlier signed into law. Along the way, the Institute for Healthcare Improve ment in Boston hosted a high-profile conference on reducing adverse drug events, and the Center for Health Policy Research at George Wash ington University Medical Center in Washington, DC, released a study stating that an estimated 1.5 million Americans require hospitalization each year — and 100,000 die — due to "injuries linked with prescription drugs."
The study noted that 51% of approved drugs "have serious adverse effects which are not detected prior to approval." It also pointed out the growing trend of post-market surveillance as the real clinical testing ground, which in turn helped prompt the FDA to increase the resources of its Division of Pharmacovigilance and Epidem iol ogy, charged with compiling adverse reaction reports on recently approved drugs.
The study coincided with editorials in the May 20th Journal of the American Medical Association calling for the need for a national drug safety czar.
Across the board, officials involved with medication error and adverse event reporting systems agree that tangible benefits are emerging from all the bad news. In particular, more health care officials are talking about solutions, and more people are reporting problems.
From the FDA’s MedWatch program, to programs overseen by the Institute for Safe Medica tion Practices (ISMP) in Warminster, PA, to JCAHO’s sentinel events reporting system, the numbers for 1998 are up. At JCAHO, self-reporting of sentinel events has increased dramatically as the agency continues to revamp certain tenets of the policy. (See a detailed update, p. 206.)
Voluntary self-reporting by accredited institutions increased by 60% as the year came to an end, with 89% of the total sentinel events before the agency being self-reported. The figures are encouraging when it’s considered that institutions potentially have more to lose by reporting to an accreditation body than to an informational service only. At the same time, the penalties for trying to hide an event that an accrediting body may discover by other means are much harsher.
Overall, of 171 sentinel events reported to JCAHO in 1997, 36 had to do with medication errors. Through July 1998, 257 events were reported, and 47 concerned medication error.
"We are also getting better root cause analyses due to a heightened awareness of the policy and the educational programs we’ve been doing," says Darryl Rich, associate director of JCAHO’s Division of Accreditation and Operation. He adds that when root cause analysis forms are submitted to the Joint Commission, "the No. 1 root cause [of a problem] we’re seeing is a lack of orientation and training, with No. 2 being communication issues, and those are things that can be improved on."
Also in 1998, JCAHO began publishing a sentinel events newsletter. "The first we did in Febru ary was on potassium chloride dangers, and, as a result, we’ve seen a substantial decrease in the number of sentinel events due to potassium chloride," he says.
The Joint Commission also is pursuing state and federal legislation to decrease the threats of public disclosure on the sentinel event documents sent to its offices. It also has begun to standardize sentinel event policies on medication use for the different types of systems — home care, MCO, or hospital — it accredits. "We’re trying to build concepts of sentinel events management into the standards," says Rich, alluding to the systemwide approach to decreasing medication errors that is gaining greater acceptance.
But there’s much more work to do. "We’re definitely in a situation where the confidentiality issue is still a problem, and also on the downside, while the message of systems approaches is out there, it’s not out there enough. You still get the reaction of, Well, I fired the director of pharmacy and solved my problem.’"
The National Coordinating Council for Med ica tion Error Reporting and Prevention in Rockville, MD, had its most productive year in 1998 by issuing a host of recommendations echoing advances sought by a lot of different voices. In March, the council issued a series of recommendations urging a systemwide approach to medication errors, internal review protocols, advocated bar code scanning, improved physician prescribing technology, anonymous reporting availability, and a blameless environment.
In July, the council adopted and published recommendations for labeling, packaging, and storage improvements aimed across the board from drug manufacturers to all types of health care institutions. And in September, the council unanimously voted to include the Institute for Safe Medication Practices as a full voting member of the body.
"Certainly in the last two years, the industry has made remarkable progress dealing with errors from the systems perspective and away from the responsibility of the individual. It’s done this by looking away from blaming the nurse or the pharmacist and instead asking, Why don’t we have a system trapping the errors and preventing the errors?’" says Diane Cousins, RPh, secretary of the council.
Council pushes for national standards
Also this year, the council has continued to develop standard definitions and categories for medication errors it hopes can be used nationally, and it is recruiting hospitals into its anonymous reporting system.
"What we knew we needed to do was get everyone thinking along the same lines, from the prescribing phase to dispensing, administering, monitoring, and use. A lot of places didn’t think a prescribing error was a medication error, they just thought it was the dispensing phase only, so we’ve brought the physician into the mix, and our definitions also bring the patient into the loop in terms of noncompliance," Cousins says.
But being a nongovernmental, nonregulatory organization, it’s within the council’s membership that the potential for turning rhetoric into reality lies. "It’s the powers of the people, I guess," says Cousins. "The regulating agencies of the [health care] institutions and the manufacturers, the Joint Commission . . . when that kind of group can agree, and they actually come to consensus on the issues, it should be powerful in and of itself, and that level of involvement makes for readily and easily embraceable issues in health care," she says.
The council is represented by a pair of trade organizations for drug makers, along with government, accrediting, pharmacy, and other healthcare advocates.
Looking ahead to 1999, Cousins says the focus has to remain on the workplace environment and even broader types of health care. "One of the clear obstacles is still liability and a willingness to share information despite the fear of litigation," says Cousins.
For more information, contact:
Diane Cousins, RPh, Secretary, National Coordinating Council for Medication Error Reporting and Prevention, 12601 Twinbrook Pkwy., Rockville, MD 20852. Telephone: (301) 881-0666.
Darryl Rich, Associate Director, Division of Accreditation and Operations, Joint Commission for the Accreditation of Healthcare Organizations in Oakbrook Terrace, IL. Telephone: (630) 916-5600.