The Orange City pharmacist has a limited supply of powerful pain medication to dispense and is under immense pressure from federal and state authorities to ensure those drugs don’t fall into the wrong hands.
Florida needed to do something about prescription painkiller abuse, but the crackdown on pill mills has produced unintended consequences, said Accardi, owner of Accardi Clinical Pharmacy.
“There has been collateral damage and those are patients who have legitimate pain,” he said. “In this climate, there are going to be patients who are going to be turned away. Some are going to be legitimate, and that is terribly unfortunate.”
The new challenges for pain patients come after federal and state officials acted to combat an epidemic of prescription drug abuse that claimed eight lives a day in Florida.
While their actions put a dent in overdose deaths, chronic pain patients, such as Palm Coast resident Charles Knighton, have been caught in the middle.
Since Florida implemented new regulations to stamp out abuse, pharmacists have refused to fill some of Knighton’s pain prescriptions. As a result, he says he can’t get all of the medication he needs to manage his pain.
“I’ve been made to feel like a drug addict — like I am on trial,” said Knighton, 54, who has a rare spinal condition called syringomyelia. “The war on drugs has become the war on the disabled.”
At Accardi’s practice, chronic pain patients must submit to a half hour interview and a criminal background check to verify they won’t abuse the drugs.
Only 1-in-10 is approved, Accardi said.
Dr. Kavita Sharma, a Florida Hospital DeLand pain medicine physician, says her patients with back, neck and cancer-related pain are sometimes forced to wait a week for their medication or are told by pharmacists that they will only fill a pain prescription if it is accompanied by other nonnarcotic prescriptions.
Her patients include professionals who need the medication to continue working, and seniors who use the drugs to stay mobile.
“They are trying to be functional, and if you take away the tools to stay functional, it can really impact them a lot,” Sharma said. “Their stress and depression rises when they lose their functional level.”
About five years ago, Florida earned the reputation as the pill mill capital of the United States. Unscrupulous pain management doctors set up storefront clinics and freely handed out pain pills with little to no medical justification.
These powerful drugs included oxycodone, hydrocodone, dilaudid and other narcotics effective at stopping pain but also highly addictive and prone to abuse.
Overdoses increased by 61 percent from 2003-2009, and, on average, eight Floridians died of an overdose every day. People flocked to the Sunshine State to buy the drugs.
In 2010, Florida was home to 98 of the top 100 oxycodone-dispensing doctors, according to the Centers for Disease Control and Prevention.
Lawmakers acted. They barred pain management clinics from dispensing pain pills from their offices. They implemented a prescription drug database that keeps records on how many pain prescriptions a patient has.
Law enforcement agencies raided crooked doctors’ offices that funneled pills to drug abusers. The authorities intended the highly publicized arrests to send a message to corrupt doctors and pharmacies that their actions would not be tolerated.
The crackdown helped to shutter pill mills, and oxycodone overdose deaths decreased by 52 percent in Florida from 2010-2012, according to the CDC.
Stopping pill abuse became a priority locally.
In one case, officers arrested Port Orange physician Dr. Ataur Rahman and accused him of trading pain pills for hundreds of thousands of dollars and sex with female patients.
Police estimated Rahman was taking in as much as $74,250 per week at the business, where he has been accused of prescribing pain medication to people without conducting exams.
He pleaded not guilty and is awaiting trial.
But these enforcement actions and new regulations also carried unintended consequences, said Michael A. Jackson, executive vice president and CEO of the Florida Pharmacy Association.
Pharmacies and physicians are sometimes scared to provide pain medication to people who legitimately need it, including terminally ill cancer patients, he said.
“You have a chilling effect where you have a physician who is becoming very wary of overprescribing and also you have pharmacists wary of overdispensing because they don’t want their licenses taken away from them,” he said. “We now have a situation where access is a problem. The pendulum has swung too far to the right. We have to find a way to bring the pendulum back to the middle.”
Also, the federal government recently reclassified the popular pain medication hydrocodone in October from Schedule III to Schedule II, making it more tightly controlled and harder for patients to fill, Sharma said.
With the crackdown also came hefty fines for some large pharmacies and distributors.
The Drug Enforcement Administration fined Walgreens $80 million in 2013 for not doing enough to stop painkillers from reaching the black market. It stopped two CVS stores in Sanford from dispensing the drugs. The drug wholesaler Cardinal Health temporarily lost its ability to distribute controlled substances from its Lakeland facility. The wholesaler settled claims for $34 million that it fulfilled suspicious orders of hydrocodone.
A report this month from the Government Accountability Office found the DEA ineffectively managed its quota system for the production of controlled substances, contributing to a shortage of pain medication.
Accardi said he is alloted a limited number of doses and must be selective in how they are dispensed.
The DEA disputed some of the report’s findings and says its actions are not causing a shortage of prescription pain medication.
“All we are asking is for the pharmacies to use their training, education and experience and look at the totality of circumstances to determine if the prescription is legitimate,” said Jeffrey Walsh, assistant special agent in charge of DEA’s Central Florida office in Orlando. “Nobody has been the subject of an enforcement action that hasn’t been a longterm, egregious and habitual offender.”
Even though it sets broad quotas for controlled substances, the distributor — not the DEA — decides how many doses are alloted to a particular pharmacy, Walsh said.
But Randy Margrave, a pharmacist at Holly Hill Pharmacy, says wholesalers are under pressure from the DEA to closely watch dispensing patterns and limit the number of doses provided to pharmacies.
One time his pharmacy was flagged by a wholesaler because it ordered more drugs in advance of a price increase, he said. Because of the limited supply, he’s not accepting any new chronic pain patients, despite the pharmacy getting 15 to 20 calls a day from people inquiring about the availability of painkillers.
“They’ve got the wholesalers shaking in their boots,” Margrave said.
Dr. Frank Farmer, an Ormond Beach physician, doesn’t think the state regulations implemented during his tenure as surgeon general from 2011 to 2012 are overly burdensome.
Pharmacists simply need to take a few moments to check the state database and ensure the prescription is legitimate, Farmer said.
“It broke the back of illegal prescription drug mills,” Farmer said of legislation passed during his tenure. “The number of deaths have gone down tremendously.”
State Attorney General Pam Bondi also defends the state regulations.
“The legislation we supported didn’t have any impact on any doctor writing a prescription or a pharmacist filling a prescription,” said Whitney Ray, a spokesman for the attorney general.
Federal lawmakers on both sides of the aisle introduced legislation last month that would require that federal agencies collaborate to develop a strategy for ensuring patients have access to pain medication while at the same time policing the system for abuse.
In a video produced by the National Association of Boards of Pharmacy, an older gentleman with a gray goatee approaches a pharmacy counter seeking a refill for Valium.
The pharmacist notices he just received a refill last week, and that prescription was from a different physician.
The footage stops. “Could (he) be doctor shopping?” the video asks.
The clip informs pharmacists they are the last line of defense and play a critical role in ensuring “a prescription being filled has a legitimate medical purpose.”
Part of their job is to notice “red flags” that a prescription may be illegitimate. The Drug Enforcement Administration says pharmacies have a “corresponding responsibility” along with physicians to ensure prescriptions for controlled substances are legitimate.
Red flags include groups of people carrying prescriptions for the same drug, paying cash for controlled substances, a prescription from a prescriber in a distant location, prescriptions for the same drug from multiple doctors, nervousness or appearing intoxicated.
Holly Hill pharmacist Margrave said getting a small prescription of painkillers filled is typically not difficult, but chronic pain patients who require many doses can encounter hurdles, he said.
“We basically have to know the patient and know the physician,” Margrave said. “If we are not familiar with the patient, we are not going to fill it.”
NO ESCAPE FROM PAIN
Knighton says he had his prescriptions filled for two decades without a problem.
He was diagnosed with his condition in his 30s, underwent a series of painful operations and eventually had to quit his job as a software engineer. He recently moved to Palm Coast from North Carolina because the warmer weather helps with his pain.
He says the terrible pain — described in his medical records as feeling like “mice were crawling their way out from his muscles”— leaves him bedridden most of the day.
Knighton said he and his doctor have developed a mixture of pain medicines over the years that makes the constant pain manageable.
Pharmacists and society have an obligation to help people like him, Knighton said.
He likes to say he’d rather fight a grizzly bear with a pocketknife than endure his chronic pain without medication.
“Pain — you can’t escape it,” he said. “It makes your life misery.”