Feds, pharmacies grapple with pain pill dilemma

BY DARA KAM
THE NEWS SERVICE OF FLORIDA

THE CAPITAL, TALLAHASSEE, October 1, 2015……Susan Langston wiped away tears as she spoke of a 40-year-old woman who had struggled with cancer for a decade before a Fort Myers pharmacy refused to fill a prescription for pain medication.

The prescription was rejected because it was written by a doctor at the Cleveland Clinic, a facility 100 miles away from the woman's home and where she sought cancer treatment after her own doctors told her she was going to die.

But, according to the chain pharmacy's policies, the prescription was flagged because it wasn't ordered by the woman's regular doctor, the woman traveled a long distance to obtain the prescription, and it came from South Florida, a part of the state once considered the pill-mill capital of the nation.

According to Langston, the pharmacist quit.

The cancer patient's plight is one of many stories Langston has fielded in her job as the U.S. Drug Enforcement Administration diversion program manager in the Miami office.

"This girl is being labeled a drug seeker, a doctor shopper. She went to a different doctor. She got a different pain medicine. She drove a long distance, and she paid cash. But she also walked in there with a bald head to a pharmacist that she's been going to for 10 years, who knows she's none of those. And that's awful. That's not what we're about. No one has ever gotten in trouble with the DEA in Florida from filling a cancer person's prescription," an emotional Langston said in an extended interview this week via Skype with The News Service of Florida.

Florida patients like the Fort Myers woman are caught in the crosshairs of a state and national crackdown on prescription pill abuse that's morphed into a dreaded "pharmacy crawl" by people suffering from cancer, chronic pain and other illnesses but who can't get their doctors' orders for pain medications filled.

Pharmacists blame an overzealous Drug Enforcement Administration for the problem. Doctors --- and the DEA --- point the finger back at the pharmacists charged with filling prescriptions or at the corporations that have developed checklists to screen out dubious patients.

Meanwhile, some patients are checking into hospice care early --- or even committing suicide --- in search of relief.

The dilemma has reached such proportions that the Florida Board of Pharmacy is considering changes to its rules regulating the dispensing of pain medications, switching from a focus on detecting fraudulent prescriptions to ensuring that legitimate patients get the drugs they need.

But most of the players involved in Florida say the proposed rule change, scheduled for a vote Monday by a pharmacy board committee, alone will likely do little to alleviate the situation.

The rule change won't have any effect on the policies of corporations like Walgreens and CVS, or on the policies of distributors who control the supply of drugs that flow into pharmacies.

"So it doesn't really matter what the state of Florida says, or the DEA, or anyone else, as long as the corporation says, this is what we think," Langston said.

Pharmacy chains won't reveal their checklists for which patients pass muster.

When asked whether CVS has such a policy, company spokesman Mike DeAngelis referred to guidelines laid out in an industry paper released this summer, endorsed by more than a dozen associations representing doctors' groups, chain pharmacies, pharmacists and distributors.

The "Stakeholders Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances" includes myriad items related to how people behave when they present prescriptions to be filled, as well as to the prescriptions themselves. One trigger is whether the patient "presents prescriptions for highly abused controlled substances," something common for patients with chronic pain or cancer.

"Our corporate office will look into any complaint we receive from a patient who believes they are being denied a legitimate prescription, but our pharmacists do a great job in using their professional judgment to determine whether a controlled substance prescription was issued for a legitimate purpose," DeAngelis said in an email.

One major concern for pharmacists involves an unwritten "30 percent rule" --- the amount of pharmacies' prescription drug orders made up of controlled substances --- that many believe triggers scrutiny by the DEA.

But Langston denied that such a rule exists.

"There's no number, officially, that triggers anything," she said.

DEA probes are sparked by a "totality of circumstances," Langston said.

"Volume, amount ordered, amount received by a pharmacy is only one of those circumstances. But we know that volume alone does not always tell the whole story. We're very aware of that," she said.

Langston is frustrated at the blame being placed on her agency.

"We want all pharmacists, patients, doctors and the public to know that the DEA does not want to interfere in any way with legitimate medical care. That would be morally wrong. We want legitimate patients to get the help and the medications that they need," she said.

But a report from the U.S. Government Accountability Office this summer, based on surveys with industry professionals and DEA officials, found that over half of DEA registrants --- pharmacies and distributors --- have changed certain business practices based on the result of the agency's enforcement actions.

More than half of distributors have placed stricter limits on quantities of controlled substances that their customers can order, the report found.

And more than half of individual pharmacies and chain pharmacies reported that the stricter limits "have limited to a 'great' or 'moderate extent,' their ability to supply drugs to those with legitimate needs," according to the report.

In contrast, DEA officials "said they generally did not believe that enforcement actions have negatively affected access."

Cardinal Health, one of the country's largest distributors, referred questions about its policies to June testimony from one of the company's top executives at the Florida Board of Pharmacy's Controlled Substances Standards Committee.

The DEA has instructed distributors not to ship suspicious orders to pharmacies and to report them to the federal authorities. Failure to do so could result in the loss of the distributors' DEA registration, Gary Cacciatore, the company's vice president of regulatory affairs, told the committee.

Cardinal Health has placed "individualized limits on each controlled substance drug family," imposed limits on particular drug strengths within a drug family and scrutinizes the drugs that the DEA has identified as being widely diverted, such as oxycodone and alprazolam, he said.

"These factors and many others play a role in our decisions to service customers and in setting limits on the distributions of controlled substances," Cacciatore said.

The DEA's actions may have had an even greater impact on the behavior of distributors and pharmacies in Florida.

In a 2012 settlement agreement, Cardinal Health was banned from shipping and selling narcotics from its Lakeland facility for two years.

Walgreens agreed to a historic $80 million penalty in 2013 related to dispensing of highly addictive narcotics.

And, earlier this year, CVS agreed to pay $22 million in fines after DEA investigators revealed that employees at two of the chain's Sanford stores were doling out controlled substances without legitimate prescriptions. Three years ago, federal authorities stopped the stores from dispensing a number of highly addictive controlled substances, including oxycodone.

According to the Government Accountability Office report, the number of DEA complaint investigations jumped nationally from 907 in 2009 to 1,428 in 2013, as state and federal authorities grappled with a prescription drug-abuse epidemic that earned Florida the dubious distinction as the epicenter of the problem.

At the urging of Florida Attorney General Pam Bondi in 2011, state lawmakers imposed strict regulations on doctors and pharmacies about dispensing highly addictive pain medications. The effort was aimed at shutting down rogue clinics that had popped up in areas like South Florida and had drawn addicts and traffickers from states hundreds of miles away.

The law barred doctors from dispensing powerful narcotics from their offices, and shuttered almost all of the pill mills where doctors wrote hundreds of prescriptions for pain medications each day.

But the pill-mill problem hasn't gone away, Langston said.

"Those same lines of people --- those people shooting up in their cars, urinating, buying and selling urine, buying and selling pills --- they ended up at pharmacies," she said.

While most pharmacists turned those patients away, "we had a lot of bad pharmacists that turned a blind eye," Langston said.

"When you have people shooting up in your parking lot, there's a problem. These aren't cancer patients or surgery patients doing this. And it's awful that people like that are having to suffer," she said.

Langston said she was in a pharmacy earlier this month when a homeless man paid $800 in cash for powerful narcotics. That pharmacy is now under investigation, she said. She watched as the man placed the $20 bills into stacks on the counter.

"It was really sad. I couldn't believe that pharmacist took that money," she said.

The DEA has no control over pharmacies' pricing of drugs, Langston said.

"They can charge what they want. That's not against the law. But when a pharmacist will do that, it's very telling. Very telling," she said.