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A general counsel on the front lines of the opioid crisis

December 1, 2018

Hundreds of lawyers are involved in the opioid crisis. Each represents various corporate interests or injured plaintiffs seeking to sue, and all of them expect to be paid big money.

Then there is Kerstin Arnold, who may be the single most important Texas lawyer involved in the opioid epidemic.

As general counsel of the Texas State Board of Pharmacy, Arnold is arguably the most influential and knowledgeable attorney on issues of public health and the pharmaceutical industry in Texas.

During the past two decades, she helped rewrite state regulations for pharmacies and pharmacists, guided cutting-edge reforms through the Texas Legislature, led a crackdown on illegal internet prescription operations and presided over thousands of investigations and enforcement actions.

Now, Arnold says she and her agency are in a battle of a lifetime involving opioid abuse.

“It is bad - it causes me to lose a lot of sleep,” she said. “Between 170 and 190 people are dying daily [in the U.S.]. That’s the equivalent to a 737 jetliner crashing every day.”

But legal industry analysts say that Arnold and her team are quietly enacting significant reforms to the state’s prescription drug databases and monitoring programs that are showing definite signs of success.

“Kerstin is passionate about protecting the public health and safety of the citizens of Texas,” said Gracie Renbarger of the Texas General Counsel Forum, which recently honored Arnold for her two decades of legal work at the state Pharmacy Board.

Arnold oversees a staff of six lawyers and 10 legal assistants. She and her office receives more than 6,000 complaints annually and handles more than 500 disciplinary cases a year against pharmacies, pharmacists and technicians. About half of the disputes involve pharmacists or their technicians engaging in illegal activity, such as stealing drugs or falsifying records. Another 25 percent of the cases deal with various forms of malpractice, including dispensing errors or failing to provide proper counseling.

Since joining the state Pharmacy Board in 1999, Arnold has faced several huge challenged.

In 2002, the internet turned the pharmaceutical world upside down, as hundreds of websites started popping up selling prescription drugs.

“Most of the pharmacy websites first focused on selling Viagra and hydrocodone,” she said. “It seemed like the crooks were ahead of us every step of the way. As soon as we figured out what they were doing and shut them down, they would change their method of operation.

Arnold and her team conducted scores of undercover sting operations by ordering drugs from these websites to see if the drugs arrived from a Texas pharmacist or a pharmacist licensed in Texas. “If they,” she said, “we shut them down.”

In September 2012, Arnold received reports of an outbreak of fungal meningitis in Texas after receiving steroid injections.

“People in Texas and everywhere started dying,” she said. “We discovered that the steroid injections from one specific pharmacy, the New England Compounding Center, were contaminated and mislabeled. I had to learn everything I could as quickly as I could about sterile compounding.”

Arnold became one of the nation’s leading experts on the legal issues and regulations regarding sterile compounding. Seventy-six people died. More than 800 others were severely sick. NECC was shutdown and paid a $200 million settlement to the victims. Fourteen of the company’s employees, including its president and chief pharmacist, went to federal prison.

“For six to nine months, it was huge - one of the worst public health tragedies in U.S. history,” she said.

But everything else pales in comparison to the opioid crisis.

“The opioid crisis is a huge crisis beyond comprehension,” she said. “We have seen people hurting their pets so that their vets would give them the drugs.”

In 2015 and 2016, Arnold worked with the Texas Legislature to move the state’s Prescription Monitoring Program from the Texas Department of Safety to the Texas Board of Pharmacy.

“The difference is that we look at the monitoring program as a clinical tool and approach the problem as a healthcare focus instead of a law enforcement focus,” she said.

“It was a big challenge to get the program working as we needed it, but we have improved the program dramatically,” she said. “Doctors, dentists, veterinarians and others are able to more easily review electronically the substances prescribed to the patients.”

Arnold also helped Texas implement the NarX Score, which provides pharmacists a quick summary of patient histories of drug prescriptions and evaluates potential abuses or even a likelihood of overdose.

“NarX is simply designed to provide analytics or a score to pharmacists indicating whether the patient may have a problem,” she said.

Legal industry analysts say that Arnold’s experience and reputation as a national expert on pharmacy law qualifies her for elite legal positions in the private sector that would pay her up to 10 times her current $130,000 salary.

“I’m happy where I am,” Arnold told The Texas Lawbook in an exclusive interview. “It is extremely rewarding to do what I am doing, trying to change the world for the better.”

For a longer version of this article, visit TexasLawbook.net.

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