COLUMBUS, Ohio — Recently proposed state legislation would criminally punish pharmacy staff who didn’t report errors related to dispensing dangerous drugs to patients.
Senate Bill 119 would require pharmacists, pharmacy interns and technicians to report those mistakes within two weeks to the state Board of Pharmacy. Not doing so would be a fourth-degree misdemeanor, according to the bill, which now is in the Senate’s Health, Human Services and Aging Committee.
State Sen. Tim Grendell, the bill’s primary sponsor, said he created the legislation to eliminate under-reporting of errors and make the pharmacy board a central repository for such information.
“I want this to be a measure for the pharmacy board so they can take remedial corrective action to help avoid serious physical harm or death,” Grendell said.
National non-profit groups and state boards collect information voluntarily, but there’s no requirements to do so. In Ohio, serious errors are sometimes reported by pharmacies but most errors are reported by patients and physicians, Pharmacy Board Executive Director Bill Winsley said.
“We’re not hearing about all the errors,” Wensley said. “I’d like to say we’re hearing about all the serious errors. But I cannot even say that.”
There’s an increasing focus on the best way to prevent and punish pharmacy errors in the wake of the death of Emily Jerry, a 2-year-old who died in 2006 after a technician mixed and a pharmacist approved a bad mix of chemotherapy solution.
The state last year passed Emily’s Law, legislation also sponsored by Grendell, that created licensing and minimum education requirements for pharmacy technicians. The pharmacist who approved Emily’s deadly mix, Eric Cropp, pleaded no-contest last month to involuntary manslaughter and will be sentenced in July.
Industry advocates have said pharmacists shouldn’t be punished criminally for accidents. Instead of punishment, some pharmacy groups have said offering immunity for most mistakes — a model used by the Federal Aviation Administration — would increase reporting and lead to faster, and more lasting, effective change.
“I’m getting concerned that we’re going to go after safety, and doing it in a way that the pharmacist is an adversary of the person collecting data,” said Ernest Boyd, executive director of the Ohio Pharmacists Association. “That won’t get us to the real root of the problem.”
Grendell said he’d consider an immunity approach. “I’m open to any proposal that will create an environment where the pharmacy board will have the information necessary,” he said. “My goal is not to do a witch hunt, but to have a safe environment for Ohio patients.”
The legislation also is structured primarily to avoid civil suits. Reported errors would not be public documents — an approach Grendell said would keep the data from becoming “the ultimate personal-injury research tool.” However, after going to the pharmacy board, the errors could be used by law enforcement officers to criminally prosecute pharmacists.
Grendell said he’d like passage of the legislation in about 18 months.
[Front-page photo courtest of Flickr user prudencebrown121]
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The Ohio State Board of
Pharmacy imposed the maximum
fine allowed on a Toledo
pharmacist in a medication
error case involving the death of
a cancer patient. In addition,
Daniel M. Scott, a pharmacist
at Riverside Mercy Home
Pharmacy Services, was charged
by a grand jury with one count
of involuntary manslaughter in
the death of 62-year-old Lyle
Ganske on July 11, 2000.
William T. Winsley, the executive
director of the Ohio Board,
explains, “Scott is used to
dispensing medications involving
no more than a 24-hour
dose. He was not familiar with
dispensing medications that
are to be administered over a
longer period of time. In the
victim’s case, the intravenous
treatment of Adriamycin® and
vincristine was supposed to be
administered on an out-patient
basis over a four-day period.
Instead, Scott dispensed four
times the four-day dosage to
Ganske, a chemotherapy patient.â€
Winsley says Scott was given
the doctor’s prescription order,
which clearly stated what
medication was needed and
how much. However, according
to Winsley, Scott failed to look
at the doctor’s order and
instead read the nurse’s
transcription that could have
been interpreted two ways.
The Board Minutes, dated
August 6, 7, and 8, 2001,
further explains that Scott
dispensed the drug without
having the correct directions
for use indicated on the label
affixed to the container and did
not indicate the directions for
use of the medication as was
prescribed by the physician.
The Board also found that
Scott failed to perform prospective
drug utilization review.
Winsley stresses that this is
“not just a medication error
case.†He notes that, “All
pharmacists need to know their
limitations because the general
public holds pharmacists
responsible and accountable
for their actions, including
those seen and proven as
errors. If pharmacists are put
into a position and expected to
perform a specific task, they
must say no if they feel unsure
or unfamiliar with the task.
Pharmacists need to know
what their capabilities are and
how not to act outside them.â€
Just prior to this case, the
pharmacy practice act regarding
license restrictions
changed. The Board now has
the authority to restrict
licenses of pharmacists,
including those involved in
error cases instead of suspending
or revoking them.
Based on the findings at the
hearing, the Board concluded
that Scott was “guilty of
unprofessional conduct in the
practice of pharmacy as
provided in Division (A)(2) of
Section 4729.16 of the Ohio
Revised Code.†Scott was fined
$1,500 by the Board. If convicted
by the court, he could
face one to five years in prison
Comment by Jen Marks — June 27, 2009 @ 2:30 pm
The is a travesty from all perspectives in this case. A travesty for the child, the parents that have to endure without thier daughter, for the pharmacist, for the hospital, and for the medical community at large. As a parent, I can admirew the energy they are expending in seeing that opportunities like this may be better prevented. The avenue in which this has been pursued is somewhat suspect though and a whole other topic beyond the scope of this comment. On the flipside, I see this as a travesty for the pharmacist, the hospital, and the community in that based on existing precedent, principles, and practice, that this criminal prosecution will lead to a silencing effect on future prevention of medication errors. We have seen this throughout the law enforcement world with internal affairs divisions inability to crack the informal veil of secrecy seen within these ranks. Negative ffedback reinforcement has not succeeded in this forum and will not succeed in the medical community. Is he guilty – YES! Is he criminally guilty – NO! Do you think this gentleman intentionally sacrificed years of his life in the academic environment, successfully past the requirements to practice Pharmacy, went to work, and willfully created an environment to “MURDER” a patient, a child nonetheless? Walk into any pediatric specialized institution and you will find safegaurds unprecedented as compared to the rest of the medical community and with that comes a veil of responsibility healthcare professionals assume beyond what you would traditionally see in other practicing environments.
At the end of the day, I feel for the family for thier loss. Nothing can return that child to them at the end of the day. They has lost out on the first day of school, graduation, a wedding, and the many other rewards that come with god’s gift. But, we must be judicious in the precedent that we are setting and criminal negligence in this case seems far to harsh. Some say and believe in the philospophy of an eye-for-an-eye, should we murder this poor soul? We already have – we just haven’t realized or know it yet.
Comment by Brett Randolph — July 1, 2009 @ 9:35 am
[...] Sen. Tim Grendell, who sponsored Emily’s Law, this year introduced legislation to criminally punish pharmacists who don’t report errors in dispensing dangerous drugs to [...]
Comment by Pharmacist going to jail over role in 2-year-old’s death : MedCity News — August 14, 2009 @ 11:47 am
[...] case sparked an uproar among pharmacy trade groups, who called the prosecution inappropriate and unwarranted. Industry advocates have said pharmacists [...]
Comment by Former UH pharmacist likely to serve full sentence after early-release appeal denied : MedCity News — December 29, 2009 @ 3:53 pm
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