Pharmacy loophole: Law allows pharmacists secrecy in prescription mistakes

Pharmacy loophole: Law allows pharmacists secrecy in prescription mistakes

CINCINNATI, OH (FOX19) - Randy Crews was just weeks away from retirement. He'd just finished up his final construction job, then planned to live out his retirement with his wife, Carmen.

Crews did have a medical problem. A problem many men his age have: high blood pressure.

It was an easy problem to control, Randy said, so long as he followed his doctor's orders to take the 300mg of Labetalol he was prescribed.

Every eight hours.

But, it was a December 2013 trip to a Kroger pharmacy to refill that prescription that Randy and his wife said nearly cost him his life and left him needing a kidney transplant.

"I BELIEVE I SAVED HIS LIFE"

They still have the pill bottle. They still have the 76 Lamotrigine tablets Kroger's pharmacist, Brittany Marino, admitted were given to the crews in that December 2013 prescription refill.

The Crews are storing the bottle and the pills they shouldn't have at their attorney's office for safekeeping while their lawsuit against Kroger and the Kenard Avenue Kroger Pharmacy makes its way through the Hamilton County court.

The Crews have lost their dining room to a dialysis machine and the $70,000 a month in supplies to keep Randy's kidneys functioning. The boxes are stacked almost to the ceiling.

"These are his kidneys," Carmen said as she showed us the dialysis setup in their dining room last week.

"This is seven days a week. He goes on the cycler at seven in the evening. He doesn't get off until seven in the morning," Carmen told FOX19 NOW.

"This is forever," Carmen lamented.

Carmen’s the one Randy credits with saving his life in April 2014, four months after the Kenard Avenue Kroger Pharmacy filled his blood pressure prescription. Crews, who got his prescriptions in three-month refills, started taking the medication in early 2014.

By April 9, Randy Crews was lying in a Cincinnati hospital. Carmen told us that doctors told her had she waited two more days, her husband would be dead.

Carmen said she knew something was suspicious about the medication because her husband, whose blood pressure had always responded to the Labetalol, was seeing his blood pressure spike.

Carmen said she called her own pharmacist to find out what was going on with her husband's prescription.

"I called the pharmacist and they identified it as Lamotrigine. It wasn't Labetalol, it was Lamotrigine and they told me it was a psych/anti-seizure medication," Carmen told FOX19 NOW investigative reporter Jody Barr.

After a five-day stint in the hospital, Randy Crews said he was sent home, carrying with him a lifetime sentence of daily dialysis treatment from Stage 5 kidney failure, commonly known as chronic renal failure.

His only other option of survival: a kidney transplant.

DEPOSITION EXPLAINS THE "HOW"

The Crews waited one year to the day of that December 2013 Kroger prescription fill to file a lawsuit against the grocery chain. The wait, as the Crews put it, was to "Give Kroger the chance to make this right," Carmen said in our interview last week.

They didn't even get an apology, the Crews told FOX19 NOW.

“Kroger was very standoffish,” Randy said, “They almost acted like they were unconcerned.”

"They, to me, wanted to treat this like he slipped and fell in the store. This is not a slip and fall case," Carmen Crews said.

On April 28, 2016, the Crews' legal team called Kroger Pharmacist Brittany Marino in for a deposition. Marino was the pharmacist on duty at the time of the Crews prescription filling on Dec. 31, 2013.

Marino admitted in the deposition that Kroger had multiple layers of checks in their dispensing protocol, but that the protections were overridden when the pharmacy put the wrong pills in the Crews bottle.

When filling a prescription, the pharmacy is supposed to scan the label on the patient's bottle, then scan the stock bottle from where the pills are being dispensed. If the labels don't match, the pharmacy computer alerts the pharmacy. The deposition shows Kroger calls this step the "accuracy scan."

The next step would require the pharmacist to take one of the dispensed pills in hand, then compare the pill to an image displayed on the pharmacy's computer screen. The final control would require the pharmacist to check the pill's identifying information printed on the label to the imprint and description stamped onto the pill, itself.

Those three error-prevention moves failed to catch the mistake in this case. Marino admitted so in the deposition.

"We can tell if it was done and if it was – you can override that and it was overridden. So, the accuracy scan did not scan," Marino told Randy Crews' attorney, Chris Macke, in her sworn testimony in the April 2016 deposition.

"So the error was identified by EPRN and he – well, and it was overridden," Macke asked Marino. "Yes," Marino responded.

Marino told Macke the pharmacy technician, David Wang, overrode the accuracy scan alert, an action "Any technician can override," Marino testified.

"Then he passes that to you for verification," Macke asked. "Yes," Marino answered, a step that required Marino to "physically examine" the pills.

"Was that done in this case," Macke asked. "Yes," Marino answered.

"Would part of your visual inspection have included comparing the numbers and letters that were printed on the pills, compared to what was on the image? Would that have been part of your verification," Macke asked, "That—yes," Marino answered.

"And your testimony is that you performed that verification then," Macke asked. "Yes," Marino answered.

The Crews pills were supposed to be stamped with NT 042, identifying the pill as a Labetalol tablet. The pills mistakenly placed in the Crews bottle were stamped ZC on one side and 82 on the other, identifying the pill as a Lamotrigine tablet.

“You would have noticed that,” Macke asked Marino, “Right,” Marino answered. “I should have noticed that, yes,” Marino said her testimony.

"I didn't notice or realize that it was the wrong imprint," Marino admitted.

The deposition testimony also showed it's common practice for Kroger pharmacists to ignore "accuracy scans" when filling prescriptions.

"Those accuracy overrides happen relatively frequently. So, yes, looking back at – would like to think that I would have noticed that. But that happens several times a day so it would –doesn't necessarily mean it's the wrong medication in there," Marino said in the deposition.

With the Crews case, Kroger's pharmacy inventory records would have shown 90 fewer Lamotrigine tablets and 90 more Labetalol tablets in the system. But, Marino's deposition shows Kroger pharmacies don't investigate discrepancies in pill counts when inventories are performed.

"Is there any comparison between what EPRN (EasyFill Pharmacy Retail Network, a system Kroger uses to process prescriptions and links all Kroger pharmacies) has in inventory and what is remaining on the shelf in inventory," Macke asked.

"No," Marino answered.

"So you would never notice this error if EPRN thought 90 tablets had been dispensed that hadn't been dispensed, you wouldn't notice an error like 90 tablets," Macke asked. "Probably not, no," the pharmacist answered.

The deposition also indicated Kroger pharmacists and pharmacy technicians did perform inventories of pills in stock. Those inventory audits were performed every three months, according to the Marino deposition.

Instead of investigating discrepancies in pill counts, the staff will "…change the on-hand EasyFill to match what's on the shelf," Marino admitted.

Marino admitted Kroger pharmacy staffers alter the inventory counts "dozens of times a day at—a given drug could be adjusted."

The only time Kroger pharmacists would report a discrepancy, Marino admitted, would be "Only in the case of controlled substances."

The pharmacy’s handling of inventory counts, Marino admitted, would have kept the pharmacy from ever knowing about the Crews prescription error, “If it was off by just 90, they more than likely wouldn’t have said anything,” Marino said.

"So there's no attempts to explain or rationalize or, or try to understand these discrepancies, correct? There's none, there's no policies for resolving the discrepancies, correct," Macke asked.

"Not that I'm aware of, no," Marino answered.

Errors are reported internally to Kroger, Marino testified, but state law does not require pharmacists to report errors to the Ohio Board of Pharmacy.

We called and e-mailed Kroger early last week, requesting an interview for this report. Knowing the company wouldn't comment on the Crews lawsuit, we asked the company to explain how it prevents errors and why those are not reported to the state.

"Thanks for reaching out. Unfortunately, we don't have anyone available to appear on camera," Kroger spokeswoman Patty Leesemann wrote in a Feb. 21 email to FOX19 NOW. Leesemann did provide this statement:

"At Kroger Pharmacy, nothing is more important to us than the safety of our patients. To ensure patient safety, we deploy rigorous pharmacy management systems and are vigilant about preventing errors when dispensing a prescription. We require every pharmacy associate to participate in patient safety training, as well as ongoing safety reviews. In addition, we regularly utilize patient and associate feedback to continually improve our processes. Our pharmacies fill more than 182 million prescriptions annually. We are committed to dispensing safe and accurate prescriptions."

PHARMACY ERRORS: "COMMON PLACE"

A FOX19 NOW analysis of the 2016 meeting minutes of the Ohio Pharmacy Board shows 41 pharmacists paid $39,700 in fines in cases related to dispensing errors.

Board disciplinary records show nine separate dispensing errors against four different Kroger pharmacists in 2016.

Board disciplinary records do not show any disciplinary actions related to the Kroger pharmacist or staffers involved in the Crews case.

{WEB EXTRA/CLICK HERE: KROGER PRESCRIPTION ERROR CASES IN HAMILTON COUNTY:}

-JULY 30, 2015: Derek J. Borcherding v. Kroger Pharmacy

The Food and Drug Administration web site estimates "at least" one person each day in the United States dies as a result of "medication errors" and another 3,561 people are "injured" each day.

We could not pull any dispensing error statistics from Ohio, Indiana or Kentucky to include in this report because none of those states require pharmacists to report dispensing errors. The only way those states' pharmacy boards will find out about an error is if a pharmacist, patient or doctor reports the error to state regulators.

"Under current law, there aren't requirements," Ohio Pharmacy Board Executive Director Steven Schierholt told FOX19 NOW.

We found Schierholt at the board’s Feb. 8 meeting in Columbus. The board declined multiple interview requests for this report in the weeks leading up to the publication of this news investigation.

Beginning in April 2017, Schierholt said, the Ohio Board of Pharmacy would have the authority to force Ohio pharmacists to report each dispensing error. But, that will not happen until the board votes to make reporting mandatory.

Schierholt noted during the interview that many pharmacies have procedures in place to prevent errors. In fact, Kroger pharmacies has controls in place in the Crews case, but the April 2016 deposition shows those controls are often "overridden."

"If those are not followed, the state of Ohio would have no idea that something had happened unless they're told that by the pharmacist or the patient," FOX19 NOW Investigative Reporter Jody Barr asked Schierholt.

"Correct," Schierholt answered.

"Do you think that's good enough right now," Barr asked. "Well, I think it certainly is something that ought to be looked at and we intend to do so," Schierholt said.

"They're kind of like a soccer goalie, they're the last line of defense preventing errors, but just like a soccer goalie, they're not going to stop every ball from going into the net," Dr. Neil MacKinnon, dean of the University of Cincinnati's pharmacy college.

MacKinnon, citing a Center for Disease Control, noted that medical errors are the third-leading cause of death in the U.S., trailing cancer and heart disease.

"In many ways, errors kind of is under the radar," MacKinnon said, "really it should be more prominent in that it is a significant public health issue in this country."

No state pharmacy board in the nation requires mandatory reporting of retail pharmacy dispensing errors, MacKinnon confirmed. To find one, you'd have to travel to Canada.

"It's really a black box. We don't know how bad this problem is, in fact, if you look at community pharmacies, there's only one place on the planet that requires and tracks errors and that's the province of Nova Scotia in Canada," MacKinnon said.

Figures in Canada could indicate just how large of a problem dispensing errors could be in the U.S. MacKinnon said the mandatory reporting system went into effect in Nova Scotia six years ago. The program was in place in 300 pharmacies there.

In those six years, those pharmacies reported more than 120,000 dispensing errors and "near-misses," MacKinnon said.

"We still have a lot of errors that are reaching patients that need to be caught," MacKinnon said, noting that a mandatory reporting system should be implemented in Ohio.

"Certainly, the board will visit it in 2017, absolutely," Schierholt told FOX19 NOW in that Feb. 8 interview.

Randy Crews was surprised to learn the state of Ohio doesn’t track dispensing errors, “It would be surprising. That seems immoral,” Crews said.

"It would seem like the normal, moral thing to do," Crews told FOX19 NOW.

Schierholt did not have a detailed timeline for when the pharmacy board might take the mandatory reporting issue up, except to say it wouldn't happen before April.

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