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Targeting Pill Mills

Clay County is ranked No. 1 in Tennessee for dispensing opioids. Now the feds are involved.

CELINA, Tennessee – A woman driving a car with Kentucky plates pulled into a pharmacy parking lot to fill her prescription, when Clay County Sheriff Brandon Boone told her she’d have to come back another day — the U.S. Drug Enforcement Administration was raiding the place and rounding up its inventory of controlled substances.

Then she said something the sheriff won’t forget.

“She said, ‘This is the only pharmacy that will fill my prescription,’” Boone said. “If any (other) pharmacy won’t fill that prescription, there’s a problem there.”

In the isolated county of about 8,000 residents, opioid prescriptions are dispensed at a rate of 191.3 per 100 people — the highest of any county in Tennessee and more than three times the national average.

That’s enough to give every man, woman and child in Clay County a prescription, twice. A USA TODAY Network - Tennessee review of 2017 data from the Centers for Disease Control and Prevention found that only 10 counties nationwide dispensed more opioid prescriptions per capita than Clay County.

Two of the five pharmacies in Clay County, three doors down from each other, are at the center of a federal lawsuit by the U.S. Department of Justice.

Dale Hollow Pharmacy and Xpress Pharmacy, in the county seat of Celina, have unlawfully dispensed extraordinary numbers of opioids to people without valid prescriptions, and have billed the Medicare program to pay for controlled substances that lacked legitimate medical purposes, according to the lawsuit, filed in February.

The 40-page lawsuit describes: Pharmacists who didn’t know how to use Tennessee’s prescription tracking system; thousands of missing opioids; an alleged Medicare fraud scheme that netted the pharmacies more than $2 million; and regular dispensing of deadly drug “cocktails” containing opioids and benzodiazepines.

The result, according to the federal government, has been the deaths of at least two people whose prescriptions were filled shortly before fatal overdoses, and at least a dozen others who obtained opioids from the two pharmacies and ultimately overdosed.

The government filed a motion seeking a restraining order against the pharmacies to prohibit them from dispensing additional controlled substances and to turn over those remaining drugs to the DEA. Federal Judge Aleta Trauger granted the motion the same day it was filed.

The investigation has also led to criminal charges against one pharmacist, with the possibility of more to come.

John Polston, 58, of Tompkinsville, Kentucky, the pharmacist in charge of Dale Hollow Pharmacy, was indicted on 21 counts of dispensing Schedule II and Schedule IV controlled substances, outside the usual course of professional practice and without a legitimate medical purpose, between April 27 and Dec. 6, 2017.

The indictments came as part of a multi-state investigation into opioids and overprescription that brought charges against more than 30 Tennessee medical professionals.

Polston is also named as a defendant in the civil case. He was released from federal custody in April under a set of conditions, including his prohibition from filling any prescriptions.

The government’s dual-pronged approach of civil and criminal action is the first of its kind, said Don Cochran, attorney for the U.S. District Court for the Middle District of Tennessee.

“It was a novel approach. Our thought was that we needed to use every tool at our disposal,” Cochran said. “The civil approach gave us the ability to go to a federal judge (to) restrain their sale of prescription opioids ... so it enabled us to protect the population of that county more quickly than we could’ve solely by the criminal route.”

‘The pharmacist is not responsible’

Dale Hollow Pharmacy’s history of skirting dispensing laws dates at least to April 2011. Formerly known as Donaldson Pharmacy, its DEA registration number was surrendered after the former pharmacist-in-charge, William Donaldson, was indicted by a federal grand jury on five counts of illegal distribution of hydrocodone.

Donaldson, also a former Clay County school board member, pleaded guilty, and in 2013 was sentenced to 15 months in prison. The Tennessee Board of Pharmacy revoked his pharmacy license.

After his indictment, Donaldson sold his stake in the pharmacy to his sister, Anne Oakley, who was granted a new DEA registration for Oakley Pharmacy, also known as Dale Hollow Pharmacy, in April 2011, according to the lawsuit.

The pharmacy’s majority stake was later sold to Thomas Weir, of Celina, around April 2014. Weir is now the majority owner of both Dale Hollow and Xpress pharmacies and is named as a defendant, the lawsuit says.

After the ownership change, the two pharmacies, which sit along a small stretch of State Route 52 running through the quiet, 1,500-person town of Celina, buzzed with far more traffic than expected in a community that size. Day after day, scores of vehicles stopped at the mom-and-pop pharmacies.

It didn’t take long for law enforcement to notice, said Clay County Chief Deputy Rick Lisi.

“We watched as we saw cars with tags from all over. Tags from Alabama, Georgia, Kentucky ... it doesn’t take a rocket scientist to deduce there was something above us,” Lisi said.

But local agencies didn’t have the bandwidth or resources to go after the pharmacies on their own, he added.

One night in April 2016, police officers responded to an alarm call at Dale Hollow and found pill bottles on the floor near the front door.

But when Weir arrived, he refused to allow officers behind the pharmacy counter and told them to leave, stating he “would rather someone steal everything than (have law enforcement) clear and secure the building,” according to the lawsuit.

“It was befuddling to us that the property owner was pretty much telling us, ‘Goodbye, you can go away now,’ ” Lisi said. “... We left with, quite honestly, a bad taste in our mouths.”

A month later, Boone, the Clay County sheriff, allegedly told the DEA that Donaldson, the pharmacist and former owner who served prison time, was back working at the Dale Hollow Pharmacy, though not directly filling prescriptions.

“We know the people that are involved in drug activity. And when you see those people consistently over and over at the pharmacies, there’s red flags all over,” Boone said.

“So we did reach out to federal investigators to assist.” The red flags continued. A DEA inspection and audit found the pharmacy wasn’t properly keeping records of its controlled substances.

The pharmacy entered into an agreement with the DEA in March 2017 promising to fix the issues. But another inspection last year found nearly half of Dale Hollow’s 15 controlled substance medications were short on inventory. Hundreds of oxycodone, hydrocodone and buprenorphine tablets that existed on paper were nowhere to be found.

Weir allegedly told DEA officials last year that his pharmacy had no obligation to take extra steps to ensure the prescriptions it filled were legitimate.

“Doctors need to be investigated. They are the ones writing prescriptions. We just fill them. The pharmacist is not responsible,” Weir said, according to the lawsuit.

Weir’s attorney, James White Jr., declined to comment on the lawsuit.

In 2018, Dale Hollow and Xpress pharmacies filled more than 20,000 controlled substance prescriptions combined.

Pharmacists are trained to notice warning signs that can suggest patients are diverting or abusing controlled substances, such as traveling unusually long distances to fill a prescription, paying high cash prices and presenting prescriptions for combinations of drugs known to be used as a “cocktail” for their strong combined effects.

The defendants noticed none of them, investigators say, despite staterequired safeguards, such as the Tennessee Controlled Substance Monitoring Program’s patient RX history reports. Pharmacists are required to enter data into the information system for every controlled substance they dispense to ensure patients aren’t diverting medications.

Small pharmacy earned over $2 million in annual sales

Pastor Josh Newberry, of Celina United Methodist Church, can see Xpress Pharmacy out his office window, where he’s watched DEA agents raid the building.

The church strives to serve the town’s vulnerable, offering a weekly hot meal for anyone who stops by and occasional financial assistance for folks’ utility bills. Overall, people in Celina take care of each other, Newberry said.

“It’s an incredibly beautiful community with some wonderful people who care very deeply about their communi-ty,” he said.

But it was hard to miss the seemingly constant traffic at Xpress across the street, and the occasional issues it may have helped facilitate, he said.

A child found a used needle outside the church last year, Newberry said, and things have gone missing, including a 36-inch brass cross from the sanctuary.

In January 2018, someone called 911 from Xpress to report a woman passed out in its bathroom from a possible overdose.

The woman had brought a prescription for a controlled substance written the day before. After officers administered naloxone, the overdose reversal drug, her condition improved, according to the government’s lawsuit.

A DEA inspection of Xpress last August found that roughly 50% of all the drugs it dispensed were controlled substances, “far in excess of the 15-20% that is typical of retail pharmacies, and twice the level that normally causes alarm to state regulators,” the lawsuit says.

Similar to Dale Hollow, the inventory lists at Xpress showed far higher numbers of pills than what were actually in its possession. More than 2,000 tablets of oxycodone, morphine and buprenorphine simply didn’t exist.

The small pharmacy earns more than $2 million in annual sales, pharmacist Michael Griffith told DEA investigators. Nearly a third of prescriptions it fills, he added, are paid for with cash.

‘Risks far outweigh the benefits’

At least two people died within days of filling opioid prescriptions at Xpress pharmacy, according to the lawsuit.

For months, both received opioids and benzodiazepines. The dangerous combination, which can cause suppressed breathing in patients, is well-documented by the U.S. Food and Drug Administration and CDC. Roughly one-third of overdoses involving opioids also involve benzodiazepines.

“Any patients on this combination, particularly on high doses of opioids, it needs to be questioned and not be taken mildly,” said Dr. Jeffrey Fudin, a clinical pharmacy specialist with three decades of experience in pain management at a Veterans Affairs hospital in New York.

That means questioning the patient and calling their physician to ask why the patient needs both medications. And even then, pharmacists aren’t obligated to fill them if they still have concerns about patient safety.

The lawsuit describes Patient E as a 46-year-old woman who received opioids and Xanax nearly every month for two years. In November 2016, she picked up her monthly order of 90 oxycodone pills at 5 milligram strength, followed by 90 Xanax 1 milligram tablets she purchased days later.

Less than a week after that final pickup, Patient E was dead. The cause: Acute combined drug toxicity from the oxycodone and Xanax, according to court documents.

Two months later, another Xpress customer was found dead. But this one, named Patient F, was receiving another drug cocktail so dangerous it’s been dubbed by some as the “Holy Trinity.”

Opioids, benzodiazepines and a muscle relaxant known as carisoprodol (brand name Soma), are a particularly dangerous combination of controlled substances that no pharmacist should dispense, Fudin said.

“When you combine the three of those, it’s a recipe for disaster,” he said. “The risks far outweigh the benefits.”

In February 2017, Xpress pharmacists dispensed 180 oxycodone pills to Patient F earlier than dates specified on their prescription. The next day, the patient was found dead, the lawsuit says.

But Xpress pharmacists aren’t the only ones accused of giving patients dangerous drug cocktails that should have been glaring red flags.

Polston, the pharmacist criminally charged with violations of the Controlled Substances Act, repeatedly gave patients combinations of opioids, benzodiazepines and muscle relaxers, according to his indictment.

“With what’s going on now, any pharmacist filling prescriptions like that needs to have their head examined,” Fudin said. “Seriously, you’re waiting to lose your license and go to jail.”

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