Pharmacists laud new patient safety legislation

September 12, 2005

Reactions throughout the health-system pharmacy community have been overwhelmingly favorable regarding the new federal legislation that would protect medical error information from being used against healthcare practitioners who report adverse events and medication errors.

Reactions throughout the health-system pharmacy community have been overwhelmingly favorable regarding the new federal legislation that would protect medical error information from being used against healthcare practitioners who report adverse events and medication errors.

President Bush signed the Patient Safety and Quality Improvement Act of 2005 into law in July. The legislation-S.544-requires federal certification of patient safety organizations (PSOs). These certifications would be valid for a period of three years and then subject to renewal. The PSOs would be charged with collecting reports of medical errors voluntarily submitted by healthcare providers for inclusion in a patient safety network of databases.

Following analysis of the reports, the PSOs would disseminate the results to providers, including recommendations, protocols, or other guidelines outlining best practices. The PSOs could be entities that have already established error-reporting credentials, such as the Institute for Safe Medication Practices, U.S. Pharmacopeia, or the Agency for Healthcare Research & Quality (AHRQ). They could have the authority to certify a new organization to function as a PSO.

"This is the first major federal legislation around patient safety," said Henri Manasse, executive VP and CEO of ASHP. "While some people wanted something much bigger than what eventually ended up here, I see this as an important step in regard to Congressional activity in the patient safety arena." In addition, he commented, "This legislation takes away the threat of being punished, and I think that's been a major barrier to the reporting thus far."

Michael Cohen, president of ISMP, a longtime proponent of a voluntary, nonpunitive medication-error reporting system, said, "The new legislation improves the condition under which people can report without fear of discovery of information during a plaintiff's lawsuit." Cohen told Drug Topics that the bill clearly communicates that if a person wants to report an error to a patient safety organization, he or she couldn't be told by his or her hospital not to do it. "That will increase the amount of information that we get. It will also help when we call the reporters and ask for additional information." ISMP operates a medication-error reporting program with USP.

Cohen said that another major component of the legislation is the fact that it protects information that would be shared for quality improvement purposes. Under the new legislation, PSOs will evaluate the data for any trends and recommend steps back to the reporting providers to avoid future mistakes.

Around the country, hospital pharmacy directors are generally supportive of the law, which they say will result in an increase in the number of errors that are reported. "The bill itself is common sense," said James Jorgenson, director of pharmacy at University Hospital in Salt Lake City. Just how important is it to protect those who report errors? "That's fairly important," he noted. "As much as we want to purport that there is this blameless culture, there's still tons of places out there where that's just not true."

James Stevenson, director of pharmacy services at the University of Michigan Hospital in Ann Arbor, believes that the new law will help improve overall safety throughout the nation because as people feel more comfortable reporting, the healthcare community should be in a better position to pick up trends and proactively head off problems.