What state boards are doing about medication errors (Web Extra)

July 1, 2009

As of June 2009, it appears that North Carolina remains the only state to require any consistent public reporting of pharmacy-associated medication errors. In North Carolina, pharmacists must report errors associated with deaths.

As of June 2009 it appears that North Carolina remains the only state that requires any consistent public reporting of pharmacy-associated medication errors. In North Carolina, pharmacists must report errors associated with deaths.

According to Jay Campbell, RPh, JD, executive director of the N.C. Board of Pharmacy in Chapel Hill, “The requirement is that one needs to report [an error] to the board of pharmacy if they have reason to believe that a dispensed drug caused or contributed to a death of a patient. It is not a mandatory reporting of serious errors, only a report of deaths. Some of the data [we gather] are made public, and some aren’t. We produce a spreadsheet of information and we scrub out certain things that are not public information,” he said.

Campbell explained to Drug Topics that the “reporting rule isn’t keyed to an error; it’s broader than that. [We require a report] even if a drug is dispensed as ordered, yet it contributed to a death. Sometimes there’s a need to investigate - especially in a hospital, where a patient may have come in with underlying problems. There does sometimes seem to be a temporal relationship.”

Error reporting is imperative, but it’s also important to make sure it’s not so punitive that you defeat your own purpose, Campbell added. “On one hand, there’s a public health need for reporting about pharmacists who commit errors - especially repeat players - where there is a question of competency. On the other hand, if you go too far you can create incentives for folks to bury errors. There needs to be some ability to have confidential discussions about errors so they can be dealt with in a candid way.”

As to the question of what types of events are reported, Campbell said, “Most folks’ intuition would be that deaths [associated with] dispensing would be in the realm of controlled substances. In our experience, we’ve seen a disproportionate number of deaths with anticoagulant products. They are a tiny fraction of global dispensing, yet they have, over the years, represented about 20 percent of reports. That information does become quite useful, and makes it easier to shine a light [on quality assurance efforts].

“So sometimes intuition is borne out by experience,” he said. “But if you are a patient taking certain drugs, it is critical to be counseled and monitored from educational and preventive standpoint.”

The NC board receives 40 to 60 reports per year. Most are from hospitals. “Community pharmacists may not have any way to know that patients have passed away,” said Campbell.

Is there ever any pressure on pharmacists to keep errors quiet? “I’ve never heard that kind of concern expressed by pharmacists,” said Campbell. “We all want people to be safe. I think the public can reasonably expect that if pharmacists are repeat offenders that raises the question of competency.

“[On the other hand] there are going to be errors. Any conscientious pharmacist can make errors, due to volume, time, etc. If you go so far that [when] a conscientious pharmacist has made an error, there is a public tarring, that is counterintuitive.

“You can go too far the other way.We don’t want pharmacists to feel so pressured about error reporting that they don’t go into the profession. That creates its own set of problems.”

Should errors be criminalized? “The [case of Ohio pharmacist Eric Cropp] stirred a lot of debate of criminal versus civil [penalties],” said Campbell. “A number of pharmacy organizations took the position that a criminal sanction is never appropriate. My answer is, you have to ask, ‘Is criminal liability appropriate in malpractice cases?’ Sometimes. It depends on the circumstance.

“What got lost in that debate [over the Ohio case] is that I did not get the sense that the Ohio authorities were taking some broad-based position that they were going after any healthcare provider criminally. Rather, under [this] very unusual set of facts [it seemed that this course] was appropriate. You have to ask, ‘What is the state of mind the person? Negligent? Reckless? Intentional action?’

“The other factor is the method of harm. You can’t disentangle the two. Those are kinds of factors that are critical to the case.”

Meanwhile, on the West Coast, Oregon legislators have established the Oregon Patient Safety Commission (www.oregonpatientsafety.org). According to Gary Miner, compliance director for the board, “[The commission] is charged with the collection and data analysis of all medical errors in Oregon. The program is currently voluntary and the hospitals are sending data to the commission. At this time the retail pharmacies are not sending data but are in discussions with the commission.”