Medication errors present benchmarking headache, no consistent measures

Lack of standardization stalls solutions

The recent furor over medication errors and patient mortality has highlighted a unique problem for quality managers and others who are trying to get a handle on how extensive the problem is in their own facilities as well as at similar institutions.

Judy Smetzer, RN, BSN, is the director of risk management services at the Institute for Safe Medication Practices (ISMP) in Huntingdon Valley, PA, a nonprofit organization that educates the health care community and consumers about medication errors and their prevention.

Smeltzer says her group doesn’t have much confidence in the validity of medication error rates outside of scientific research, for several reasons. "There is no consistent process of defining, detecting, and reporting errors among health care facilities," she says. "Many errors are unreported because they cause no harm or are corrected before they reach the patient. Other mistakes simply may not be associated with a bad outcome in a critically ill patient."

Even when errors are detected, they may not be reported, she adds. "Error reporting by practitioners is notoriously unreliable. Staff may fear punishment or disciplinary action, or they may want to avoid embarrassment. Discomfort with reporting errors is so profound that only 5% of all errors detected through research methodologies have been reported simultaneously by practitioners."

Most medical facilities require that medication errors be reported to hospital administrative personnel. Sue Wright, RPh, MPA, executive director of diagnostic and therapeutic services at Memorial Hospital and Health System, a tertiary referral center in South Bend, IN, reviews medication error reports from a variety of sources, such as the nursing floor.

"At Memorial, we are changing the way that we address medication mistakes, and we’ve seen an improvement in our error rates. We look at medication errors as a percentage of the total doses that we process. We track everything from the time that a physician places an order until the patient has received the medication, and we’ve seen problems all along the line — in prescribing, in dispensing, and in administering medications," she says.

Memorial uses a computerized medication error reporting system. The information is transmitted from, for example, the nursing unit to the master hospital database administration system. Wright, the hospital risk manager, and the pharmacy director receive a daily report of those errors, and the pharmacy director follows up on noteworthy mistakes.

"A group in our pharmacy department reviews medication errors," says Wright. "Certain problems merit medical staff involvement by our pharmacy and therapeutics committee and then might be forwarded to the medical staff quality assurance division for review."

Wright says Memorial Hospital has a philosophy of benchmarking that involves best practice. "We look for the best performance in a particular area by a comparable institution, and then we compare our performance. We’ll confer with that institution to see how their methods could be adapted for our use. With respect to medication errors, we look for a facility that has either a low error rate or for one that has dealt with a sentinel issue and has performed a root-cause analysis to help prevent future incidents."

Lewis Sanders, RPh, a staff pharmacist at St. John’s Mercy Medical Center, an 859-bed level I trauma center in St. Louis, says most pharmacy errors at his facility are discovered by a licensed pharmacist who double-checks all medications before their release. "Many of the errors we catch have been caused by illegible writing on a script or by a misunderstanding from a phone order. Look-alike’ and sound-alike’ drugs also present a problem. We are notified of errors that do occur — and their outcome — to prevent future mistakes," he explains.

In a facility like St. John’s, there’s often a high volume of orders to be filled. "During a peak period on a busy day, we might process hundreds in an hour," Sanders says. "One of the best safeguards is having an accurate and decipherable order from the outset."

Organizations such as the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD, and the ISMP are dedicated to improving the quality of pharmaceutical care via education, collaboration, and the communication of the most current safe medication practices to clinicians and consumers.

John P. Santell, MS, RPh, is the director of the Center on Pharmacy Practice Management of the ASHP, a 30,000-member national professional association that represents pharmacists who practice in hospitals, HMOs, long-term care facilities, home care, and health care organizations.

ASHP has collaborated with the American Medical Association, the American Nurses Associ-ation, the Institute for Healthcare Improvement, and the ISMP to find ways of reducing adverse drug events.

ASHP’s guidelines for preventing medication errors in hospitals are used nationwide, and its Web site (http://www/ashp.org) provides standards of practice, current pharmaceutical news, and educational opportunities designed to improve the care that pharmacists provide to patients in health systems.

"Benchmarking that applies to reducing medication errors should first be a self-evaluation: How successful we are now as opposed to last month?" says Santell. "There is no national medication error rate average that serves as a gold standard for performance comparison, and there is no standard denominator for a medication error."

And numbers don’t tell the whole story, he says. "An institution with a higher error rate [a higher number of events] may simply be doing a better job of detecting and documenting its errors than a facility that has a lower rate. Classic comparison-counting approaches do not work very well with respect to determining an accurate rate of adverse events."

The medication use process in most hospitals has four domains: prescribing, dispensing, administering, and monitoring, Santell explains, with diverse tracking in those areas. And, until recently, medication error monitoring has not had a high priority, so accurate data were difficult to accrue. But, that’s changing, in part due to a sentinel event policy implemented by the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL.

"The reason for tracking is not to document numbers; it is to learn something from adverse events and to prevent such events in the future," he says.

The ISMP publishes a biweekly newsletter, the ISMP Medication Safety Alert, that educates medical practitioners, hospital administrators, and members of the pharmaceutical community about safe medication practices.

The ISMP Web site (http://www.ismp.org) provides practitioners and consumers with the most current information about drug alerts and preventing medication errors. ISMP staff also offer presentations on medication error prevention and provide on-site evaluations of the entire medication use process. The evaluation includes a four-hour workshop and a comprehensive written report that provides a system analysis of weaknesses in the medication use process as well as practical recommendations for reducing the potential for errors.

"We’ve seen some really complex error reporting processes that are impractical," Smetzer says, "too cumbersome for use by busy physicians, nurses, and pharmacists. And we don’t really see many cultures today that genuinely encourage error reporting. If a hospital is using a medication error rate derived from practitioner reporting systems as a benchmark, that hospital is tacitly encouraging its staff not to report mistakes."

The definitions of "benchmarking" differ widely among institutions, Smetzer notes. "Actually, there are two components of benchmarking: The benchmarks themselves are measurements [that we know are not standardized among institutions], and the enablers are the specific practices that result in an outcome. The practice must be matched with the outcome. Benchmarking is not just a comparison of outcomes. It must be a combination of standardized measurement and a study of the processes that cause results."

Smetzer says she sees a role for benchmarking if it is focused on specific areas. For example, when the ISMP works with an organization such as The Hospital and Health System Association of Pennsylvania to create a benchmarking program, the organization first collects in-depth information about medication use practices and processes. An area of focus is determined — errors that involve heparin or insulin use — and indirect measures of errors rather than incident reports are studied.

"For example, if medication errors involving heparin are studied, we’ll ask for a measurement of the number of partial thromboplastin time test results over 100, data on the administration of protamine, and other indirect measures that would indicate that something is going on with heparin infusions," she says. "Lab values and the use of reversal agents are examples of nonthreatening’ data that can be accurately collected. If events are closely related to practices, we can begin to match outcomes with those practices."

Tips for a good program

Smetzer, Santell, Wright, and Sanders have some sound ideas for organizations that want to look at their medication error rates and create quality initiatives to improve them. Their suggestions are:

• Set up a nonpunitive system of error reporting.

• Use a systems approach to reduce medication errors.

• Use a root-cause system analysis to identify the source of problems; don’t blame a particular staff member or department for making a mistake.

• Maintain a voluntary, well-publicized reporting system, and work hard to make staff comfortable with reporting errors so the system can be made better.

• Organize a multidisciplinary team that includes physicians, a pharmacist, organizational development staff, nurses, and technicians as well as a trained group facilitator to address medication errors in high-risk departments such as neonatal intensive care.

• Communicate medication orders in a standardized format.

• Use protocols that contain dosage calculation formulas and dosage range checks. Put alerts in place to flag the dangers of high-risk or toxic drugs.

• Eliminate all transcribing of handwritten and oral medication orders in favor of computerized order entry. Use this also for the documentation of medication administration records.

• Make sure that at least one pharmacist is available 24 hours a day.

• Instruct pharmacists to work on patient care units side-by-side with physicians and nurses.

• Put the pharmacy in charge of preparing and calculating the doses of all intravenously administered medications.

• Standardize administration times throughout the hospital.

• Use bar coding to ensure the "five rights": the right drug, the right dose, the right strength, and the right patient at the right time.

• If possible, involve patients as active partners in their care, and educate them about the effects of medications taken.

• Ensure that nurses, physicians, and pharmacists can access certain key information on all patients.

• Abandon the use of calculating an error rate from spontaneous error reporting systems, and do not compare numbers of mistakes as a benchmark for medication error rates.

• Use focused surveillance to collect data on adverse events, and analyze the practices that cause those events. This type of nonthreatening data collection is more effective than relying solely on voluntary or mandatory reporting.

• Continue to calculate an "error reporting rate." The goal should be to have a high reporting rate; the more errors reported the better the detection plan and the more you know about your medication use system.

[For more information, contact:

• Anthony Vecchione, Senior Editor, Drug Topics’ Hospital Pharmacist Report, Five Paragon Drive, Montvale, NJ 07645-2490. Telephone: (201) 358-4488. E-mail: tony.vecchione@medec.com.

• Sue Wright, RPh, MPA, Executive Director of Diagnostic and Therapeutic Services, Memorial Hospital and Health System, 615 N. Michigan St., South Bend, IN 46601. Telephone: (219) 284-7125. E-mail: swright@memorialsb.org.

• John P. Santell, MS, RPh, Director of the American Society of Health-System Pharmacists Center on Pharmacy Practice Management, ASHP Headquarters, 7272 Wisconsin Ave., Bethesda, MD 20814. Telephone: (301) 657-3000. E-mail: jsantell @ashp.org.

• Judy Smetzer, RN, BSN, Director of Risk Management Services, Institute for Safe Medication Practices, 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006. Telephone: (215) 947-7797. E-mail: jsmetzer@ismp.org.]