In an effort to limit a disturbing increase in prescription drug abuse, the Food and Drug Administration recommended stricter regulations on the most commonly prescribed painkillers.
The policy shift announced two weeks ago will place heavier controls on painkillers containing hydrocodone–drugs like Vicodin, Lortab and their generic equivalents. If the recommendations are approved by the Department of Health and Human Services, hydrocodone painkillers will join powerful narcotics like OxyContin and morphine as Schedule II drugs, considered to be substances with high potential for abuse and addiction.
Local critics say the change will do little to stem misuse and will instead deny elderly patients relief from pain and possibly even fuel a black market for opioids.
After previously rejecting a similar measure proposed by the Drug Enforcement Agency in 2008, the F.D.A. decided to reevaluate its decision in the wake of evidence of widespread prescription drug abuse.
The Centers for Disease Control and Prevention say abuse has become a national epidemic, with drug overdose death rates reaching an all-time high. The loss of life due to overdoses has tripled since 1990 and has outpaced motor vehicle fatalities. Overdoses on painkillers made up three-quarters of all overdoses, more than cocaine and heroin combined. Hydrocodone-acetaminophen, the generic name for Vicodin, was the second most commonly found drug in these deaths, behind methadone, according to the most recent data from the Poison Control Center.
“We prescribe way more strong pain medication than is necessary,” said Dr. Michael Whitt, the founder of the West Marin Medical Center. “Reducing the use of opiates, aside from those prescribed for cancer and terminally ill patients, would be of benefit to any community, not just ours.”
Hydrocodone combination painkillers are the most commonly prescribed drug in America, with more than a hundred million of prescriptions written each year. In 2012, a total of 752 million pills were sold in California alone, the D.E.A. said. The painkillers most often combine hydrocodone, a substance derived from the opium poppy, with acetaminophen, used in Tylenol, or ibuprofen, trademarked as Motrin and Advil. (Pure hydrocodone is already a Schedule II substance.) The lower concentration was touted as safeguard against addiction, but the F.D.A.’s policy change defies this argument.
If approved, patients will be forbidden from refilling their hydrocodone prescriptions without a handwritten note from their doctor, whereas currently doctors can phone in or fax an authorization. The six-month period for refills would be cut in half to 90 days. The changes will likely go into effect in 2014, said Dr. Janet Woodcock, the director of the F.D.A.’s Center for Drug Evaluation and Research.
The local pharmacist worries that the new regulations will place an unnecessary burden on her customers and may even put her out of business.
The customers at West Marin Pharmacy, the only druggist in West Marin, hardly look like drug fiends or pill pushers. Employees regularly fill prescriptions for cholesterol, high blood pressure and diabetes. Some patrons come with prescriptions to ease pain from short-term injuries, arthritis or chronic conditions—and often leave with Vicodin.
“Unfortunately, it’s going to affect people who are not abusing these drugs,” said owner Zsuzsanna Biran. Most of her clientele is elderly, and she says she can see they are using the drugs for legitimate purposes. “I know they are not faking their pain. I know them personally, I see them on the street. They need this medication.”
More regular visits to the doctor’s office to obtain a paper copy of a prescription could be difficult for some of her customers. Many in the area do not have cars, and if they do, they often should not drive while using the drugs, she said. Others are so incapacitated by their pain that they will be forced to send someone to retrieve their medication, creating a risk that some pills will be stolen by this third party, she added.
Many patient advocacy groups, including the American Medical Association and the American Cancer Society, have come out in strong opposition to the regulations. “As policymakers craft solutions to address prescription drug abuse and diversion, it is critical that they do not unintentionally discourage physicians from appropriately treating pain or reduce access to prescription drugs for patients who are suffering,” Dr. Ardis Dee Hoven, the president of the A.M.A., said in a statement. “The change may limit legitimate patient access to this medication, particularly for nursing home and hospice patients requiring immediate pain relief.”
Others say opioid painkillers are dangerous, particularly among the elderly, in whom they can lead to an increased risk of falling, said Dr. Jeffrey Harris, a senior physician at San Rafael Medical Center and an author of guidelines for the Care Management Institute. He hoped the change “gets people thinking maybe it isn’t as harmless as we thought.”
Ms. Biran said a greater concern is the pharmacy’s financial viability. The supply of drugs is closely monitored by the D.E.A., and Ms. Biran is only allowed a to purchase a certain ratio of Schedule II substances from her wholesaler in comparison to the rest of her stock. She said she already has trouble making a profit, and would not be able to afford purchasing a vast supply of drugs that will expire on her shelves. She said she will not—and legally cannot—charge more for drugs, nor could local doctors simply make up prescriptions to fill a quota to meet her needs. And there are only so many potential patients in West Marin.
“I’m between a rock and a hard place. It puts me in that position,” she said. “There’s not a way that I could make money. What’s the point of being in business?”
Besides presenting obstacles to an older population, the regulations also contend with a culture of painkiller abuse among Marin’s youth.
Last year, 20.9 percent of Americans over the age of 12 admitted to nonmedical use of prescription drugs, making those drugs second in popularity behind only marijuana, according to the National Survey on Drug Use and Health.
Across the San Francisco Bay Area, 3,173 were treated in emergency rooms for non-medical use of hydrocodone between 2004 and 2011, according to data maintained by the Drug Abuse Warning Network. In Marin, 13 people died from prescription drug overdoses during the last two years; in comparison, 14 overdosed on illicit drugs and 25 died in vehicle fatalities, reports from the county coroner’s office show.
And these numbers underestimate how widespread the problem is, said Mark Dale, a Terra Linda parent whose son battled a painkiller addiction, leading Mr. Dale to found Families for Safer Schools. The coroner’s reports do not indicate whether the prescription drug abuse may have led to deaths from suicide or other causes, nor the number of youth who overdose outside the county, he said.
Within the past year, at least three Marin youth overdosed on prescription drugs while away at college. In September 2012, Carly Callaghan, a 22-year-old San Anselmo native and graphic design major at Chico State University, was found lying on her dorm room floor after an accidental overdose on alcohol, Prozac and morphine. Last December, Alec Jacob “A.J.” Torchon, of Novato, a sophomore biopsychology major at the University of California, Santa Barbara, mixed a painkiller called Opana with a small amount of alcohol, causing his body to go into respiratory arrest and resulting in his death. In February, Zachary Alan Armel, a 24-year-old graduate of University of Colorado in Boulder, died from an opiate-related overdose.
“It’s brutal as far as the number of kids we’ve lost,” Mr. Dale said. “What’s the number that will get your attention? Is it 10 deaths or 20? I’ll tell you, when it’s in your own home, when it’s just one of your kids, it will turn your world upside down.”
More than half of painkiller abusers said they obtained the drugs from a relative or friend for free, and another one in five said they received them through prescription from a doctor, the National Survey on Drug Use and Health found, leading to questions of how best to limit the supply.
Advocates of the F.D.A. regulations say greater restrictions will lower the supply of Vicodin and Lortab, reducing the chances they will be illegally given away, sold or stolen. “We have so many narcotics floating around in the community now. That’s what’s behind the deaths and the overdoses,” said Dr. Harris, who has advocated for more thorough evaluations and better record-keeping when prescribing opioid painkillers. “If there is a large, unscreened supply of something dangerous, the risk tends to go up.”
But critics argue the supply of illicit drugs will not substantially change. Though some abusers will likely be deterred, others may turn to stronger opioids to satisfy their addictions and painful withdrawals. Still others may turn to more desperate measures: Ms. Biran’s said her pharmacy was robbed twice last year, though the culprit was unsuccessful in obtaining drugs.
Dr. John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory in the California Pacific Medical Center Research Institute in San Francisco served on the advisory panel of experts that recommended stricter controls for hydrocodone combination drugs. In January, he sided against the policy change in the committee’s vote of 19-10, fearing addicts would turn to heroin and other drugs on the black market where there is no possibility of regulation. He supports the aim of reducing prescription abuse, but found placing the drug in Schedule II to be “an incredibly blunt tool” that is “unlikely to be effective at all.”
The regulations may encourage potential abusers to seek out rogue doctors who are looking to make a profit with easy access to painkiller prescriptions, Dr. Mendelson said. These doctors can prescribe “enormous quantities of opiates” with quick check-ups—if an examination is done at all. “It’s how dishonest doctors make their living,” he said. “Now they have a justification for having addicts coming in. Now they have to come and be seen.”
Dr. Ray Poon-Phang Seet operated a general practice in Petaluma until his license was revoked by the California State Medical Review Board in mid-September. (Dr. Seet did not respond to multiple requests for comment. He is currently appealing the revocation, his fourth appeal since 1996.) Dr. Seet prescribed narcotics prolifically, writing 548 prescriptions for hydrocodone-acetaminophen in 2010, along with roughly 8,800 other prescriptions. Half of the patients at Dr. Seet’s “cash only” practice consulted him for pain management.
The medical board’s decision was based on multiple cases in which Dr. Seet was found to have prescribed drugs without examination, kept inadequate records and committed repeated acts of negligence.
Dr. Seet’s future wife walked into his office in the spring of 2005 and walked out with two prescriptions to assuage her headaches and attention deficit hyperactivity disorder. The records call her “J.B.” She was in her 20’s and had recently moved to Marin from Santa Clara County, after being convicted of passing false checks and methamphetamine use. Dr. Seet appears to have known of J.B.’s drug problems—he wrote a letter about her prescriptions to the Women’s Correctional Facility in San Jose a month later—but he authorized both drugs without noting any tests or referrals to a specialist.
Dr. Seet had engaged in intimate relations with J.B. before he became her physician, the review board says. Shortly after, J.B. moved in with Dr. Seet at his home in Novato. By March 2007, they were married. He stayed with her through a May 2008 incident when she careened into a neighbor’s home while driving under the influence and seems to have ruptured her left breast implant; a November 2008 search of their home during which police found evidence of meth use and numerous “pay/owe” slips; a January 2010 probation search of their home that turned up marijuana; a July 2010 probation search that turned up meth; and multiple failed stints at treatment facilities.
Through it all, Dr. Seet prescribed controlled substances to his wife, including medical marijuana, Ambien, Adderall, Xanax, hydrocodone painkillers and Oxycontin. In one note from 2009, Dr. Seet listed his wife’s illness as “sober months,” the board found.
In 2007, another patient, A.B., a 28-year old female, asked for treatment for neck pain from a car crash that summer. Dr. Seet prescribed hydrocodone and authorized additional painkillers when she returned to complain of more pain in 2008. A physician and a pharmacist both contacted Dr. Seet, warning that A.B. was visiting multiple doctors for prescriptions—Dr. Seet most frequently. He ignored them both.
In late 2008, A.B. visited again, complaining of neck pain from two car accidents with different dates from the initial accidents she reported. A.B. filled 24 hydrocodone prescriptions from Dr. Seet during a six-month period without an appointment. After six more refills, Dr. Seet ordered a urine test for the first time, but the results came back negative for the drugs he had been prescribing, suggesting A.B. was selling the drugs. No mention of the drug test was made; another 16 prescriptions were filled. The review board found no documentation of a physical examination for the three separate car accidents over four years.
With physicians like Dr. Seet, misuse may continue or even be bolstered. Dr. Whitt, of West Marin Medical Center, doubted the regulations would do enough to change doctors’ habits. “Making it a little more time consuming for the doctor is unlikely to address the problem, which is one of culture, to which many doctors, wittingly or unwittingly, contributed,” he said.
Ask almost any doctor and he or she will tell you pain is subjective and often difficult to confirm with physical evidence. How, then, do lawmakers weigh the pain of millions of patients against the pain of addiction and overdose? What’s worse?
It’s a question that doesn’t have a right answer, but doctors, pharmacists and patients are hoping the F.D.A.’s latest prescription—for prescription drug abuse—won’t have too many side-effects.