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As drug deaths mount, new law stalls tighter state regulation

TALLAHASSEE — In their zeal to slow down government regulations, Florida lawmakers have inadvertently halted an effort to regulate so-called "pill mills" that fuel an epidemic of prescription drug abuse.

The rules were set to take effect Sunday for most pain clinics. But they have been stalled by a new law intended to crack down on expensive state regulations. The law requires legislative approval of rules that have a significant fiscal impact on commerce.

That means the drug regulations could be in limbo until next spring when the 2011 legislative session convenes, according to state health officials.

"I would like legislators to explain the fact that the drug epidemic continues to grow while they remain silent," said Lynn Locascio, a Crystal Beach woman who founded Parents Against Prescription Drug Addiction. "We feel like we're back to square one banging our heads against the wall."

Locascio's 26-year-old son, Robert Palmisano, has been clean from pills since 2006. Before, he was one of hundreds of addicts who go from doctor to doctor to get their fix of pain meds such as Oxycodone.

"If some of these lawmakers were just walking in these sneakers for one day … ," Locascio said, before pausing and saying she didn't wish her story on anyone.

The new regulations provide basic standards for pain clinics, including how patients are evaluated and the physical specifications of offices. The rules also require annual unannounced inspections.

Many clinics are currently unregulated because they don't accept health insurance.

"If you accepted only cash, there were no regulations," said Paul Sloan, who runs a Venice-based pain clinic and heads an association that supports the rules. "An inspector can't go in and say 'Gee, you don't meet the rules' when there are no rules."

The new law regarding agency rulemaking — enacted last week when the Legislature over-rode a veto by Gov. Charlie Crist — requires legislative approval of new rules that cost more than $1 million over five years.

Right now there are roughly 600 rules proposed by agencies that have not yet taken effect. It's difficult to know how many of those will require final legislative approval because agencies now have to prepare more comprehensive cost estimates.

Under the new law, a proposed rule needs legislative approval if it has more than $1 million adverse impact over five years on economic growth, competitiveness, employment, investment, job creation or regulatory costs.

The state Board of Medicine will discuss the pain clinic regulations at a Dec. 3-4 meeting in Orlando. Afterward, the board will review an updated cost estimate to see if the new rules must be ratified by lawmakers.

So what will happen in the meantime?

"What's going to happen is nothing," said Sen. Mike Fasano, R-New Port Richey. "And seven more people will die each and every day until the Legislature ratifies these rules that are being approved by the Board of Medicine and the Department of Health."

Fasano was a lead supporter of pill mill regulations and also voted against over-riding Crist's veto of the bill last week, arguing it needed more study. He said he accepts responsibility for not mentioning the pain clinic issue when the bill was being debated.

Sponsors of the rulemaking bill stood behind their decision to enact the law, saying it was needed to reduce regulations.

Although much of the focus of the law is on the cost to regulate businesses, House sponsor Rep. Chris Dorworth, R-Lake Mary, portrayed it as an effort to save tax dollars. "Our goal is to get a firm grip on rules that have a high level of expense for state government," he said.

Sen. Mike Bennett, the Bradenton Republican who sponsored the bill in the Senate, said one problem is that agencies take so long to craft new rules.

"Had they gone to work and had it done right away, we wouldn't be messing around," he said. "The pill mill problem is a statewide emergency. They should've started on it immediately."

Cracking down on prescription drug abuse has received wide support in the Legislature. The new drug regulations were passed in 2009, and lawmakers approved setting up a statewide database this spring to track drug purchases and monitor "doctor shopping" by addicts.

The database was supposed to be in place Dec. 1, but has stalled because of a contract dispute. Also, there is only enough money to run the database for a few months because lawmakers ordered it to operate on donations.

"We need to start checking on these pain clinics that are operating illegally and start shutting them down," said Bruce Grant, director of the state Office of Drug Control and an advocate of "pill mill" regulations. "It's not in the interest of Florida to have these pain clinics operating without any guidelines. Any help we could get would be appreciated."

The new regulations on pain clinics have been in the works since August 2009. Sloan, the pain clinic owner, called them "rather complex" and said they needed thorough vetting to ensure unscrupulous clinics couldn't find loopholes.

He was frustrated that the rules were only days away from being imposed and now might be delayed until the spring.

"It seemed to be a rush to flex muscle and no one thought about what effect it would have," he said of the rulemaking bill. "I think it's hugely embarrassing."

Tallahassee bureau chief Steve Bousquet contributed to this report. Lee Logan can be reached at or (850) 224-7263.


Prescription drug fatalities:

• Florida prescription drug deaths in 2009: 2,488

• Average number of deaths per day: 7

• Oxycodone alone caused 1,185 deaths in 2009, a 26 percent increase from 2008, and a 249 percent jump from 2005.

Source: Florida Department of Law Enforcement and state Office of Drug Control.

The new rules would:

• Require pain clinics to register with the state and be inspected annually.

• Give inspectors access to patient records to ensure regulations are followed.

• Ensure that drugs are prescribed by licensed physicians.

• Set guidelines about how patients are examined, monitored and treated.

• Require safe storage of controlled substances.

• Establish penalties for violations.

Source: Florida Department of Health

As drug deaths mount, new law stalls tighter state regulation 11/23/10 [Last modified: Tuesday, November 23, 2010 10:41pm]
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