USP reporting system granted legal protection in Oklahoma

One of the biggest barriers to health-care practitioners reporting medication errors or adverse drug events (ADEs) is the fear of punitive or legal action. That barrier has been removed in Oklahoma.

In a bold move, the Oklahoma State Board of Health approved the United States Pharmacopeia (USP) as a national reporting organization through which health-care practitioners can submit data about medical errors. Under the public health and safety statute (Title 6 3 O.S. 1-1709), reports that are submitted will be considered privileged information and may not be introduced as evidence in any legal proceedings.

State health officials said that they approved the statute and incorporated legal protection as a way to encourage health-care professionals within Oklahoma to report medication errors and other mishaps more frequently. Health officials believe that the anticipated increase in reporting to USP as a result of the legal protection afforded reporters will help contribute to a reduction in morbidity and mortality rates. They also anticipate the ability to provide a better means of identifying trends and implementing systemwide improvements that could help prevent medication errors and ADEs in the future.

The legal protection will be given to institutions and individuals who report to USP’s Medication Errors Reporting Program (MERP), which is run in collaboration with the Institute for Safe Medication Practices (ISMP). USP’s MedMARx Internet-accessible reporting program for hospitals will also be covered under the statute.

Diane Cousins, v.p.-practitioner and product experience division at USP, in commenting on the Oklahoma State Board of Health’s decision, said, "This is the first time I’m aware of that we are specifically granted legal protection for information submitted to our reporting program." Cousins said that, under the statute, "hospitals can share freely the information about an error, without fear of disclosure, in a way that would have repercussions for either the institution or the individual."

Cousins believes the statute will not only help increase reporting within the state of Oklahoma but will be a model that other states can look to in providing this kind of protection. "Ultimately, the benefit to everyone is: If we have a larger data set more representative of problems occurring nationwide, we will have a better idea of not only what errors are occurring but what their causes are."

Terry Harrell, director of pharmacy at St. Anthony Hospital in Oklahoma City, said that providing legal protection to USP’s medication error reporting program would probably lead to an increase in reporting by health-care practitioners. However, Harrell expressed concerns about individuals who choose to report to other national reporting programs, such as FDA’s MedWatch. "That’s one of my legal questions. I don’t know if MedWatch is protected legally," he said.

Gordon Deckert, general counsel for the Oklahoma State Board of Health, said that the vote to select USP was unanimous. He added that Oklahoma was one of three states in which the state board of health is the governing body to the health department.

In the opinion of David Brushwood, R.Ph., attorney, and professor of pharmacy health-care administration at the University of Florida in Gainesville, the legal protection provided to reporters under the statute isn’t that impressive. Brushwood noted that the fear of discoverability is often used as an excuse not to report medication errors. "Usually when people say they will not report medication errors because of discoverability, it really isn’t discoverability that’s the reason for their not wanting to report. It’s something else." And what is that? In Brushwood’s opinion, it could be simply that the practitioner doesn’t feel he or she has enough time to do it or fails to see the value of reporting. Another reason, indicated Brushwood, is that a pharmacist may feel that it’s not somebody else’s responsibility or business, and he will decide how to take care of quality-related issues his own way.

Embarrassment, too, could be another reason people are reluctant to report errors or ADEs. "People don’t necessarily want to share their failures," Brushwood said. He added that, in his view, centralized reporting is far less important than localized continuous quality improvement (CQI) activities. "It’s much more important for pharmacists to organize local continuous quality improvement programs than it is for them to participate in central reporting systems." He added, "My fear is that pharmacists will view centralized reporting as a substitute for localized CQI programs, rather than as merely as a tool."

A spokesman for FDA’s Medwatch was not available for comment at press time.

Anthony Vecchione

Tony Vecchione. USP reporting system granted immunity in Oklahoma.

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