Regulation of Prescription Drugs Could Spell Trouble for Patients

Prescriptions for oxycodone, the active ingredient in OxyContin, rose 82 percent in New York State between 2007 to 2010. A new bill that just passed the legislature aims to curb the problem of abuse, but many in the medical community say it could negatively impact the people these drugs are intended for. AP/Toby Talbot

On June 11, the New York State Legislature passed the I-Stop bill. The legislation, expected to be signed by Gov. Andrew Cuomo, will require the creation of a new electronic prescription database. Physicians and pharmacists who write and fill prescriptions for Schedule II, III, IV and V drugs must enter the prescriptions into the database immediately. Currently, there is an electronic database for prescriptions, but doctors and pharmacists have a 45-day window for entering prescriptions, and doctors complain that the system functions slowly.

The bill will also place stiff fines on doctors who fail to immediately report prescriptions: $500 for first-time offenders and up to thousands for repeated offenses. The bill’s central aim is to keep powerful opioid and anti-anxiety prescription drugs, particularly oxycodone — the active ingredient in the opioid painkiller OxyContin — out of the hands of addicts and drug dealers.

When abused, oxycodone can produce a high similar to heroin, but for patients in severe pain, especially chronic pain, oxycodone simply provides relief rather than any high.

A concern of physicians, pharmacists, pain patients and medical organizations now is that the new system is being set up hastily and without enough input from the medical community. The result, they say, will be an overburdened system in which patients in serious pain have difficulty accessing their medications, since many doctors will likely stop prescribing powerful prescription drugs to avoid facing fines. Many also fear the new regulations will have negative unintended consequences, like an increase in heroin use and production.

A Growing Epidemic and an Experimental Regulation

The I-Stop bill has two central components. The first is the requirement that within a year from it becoming law, all narcotic prescriptions must be put into the system in real-time. The second mandate is that by the end of 2014, a new electronic prescription system must be in place, nullifying the need for the paper prescription pads that can be stolen. It’s new regulatory terrain because no other state has both of these requirements.

Attorney General Eric Schneiderman has said the I-Stop bill will prevent “doctor shopping,” when addicts and drug dealers receive multiple prescriptions from different doctors in a short period of time, get prescriptions they don’t need through unsavory doctors or in some cases forge prescriptions with stolen prescription pads.

The main drug being eyed is oxycodone, prescriptions for which rose 82 percent in New York state between 2007 and 2010.

New York State Attorney General Eric Schneiderman has been calling for an electronic prescription database to prevent doctor shopping for nearly two years. As soon as Gov. Andrew Cuomo signs off on a bill, which he's expected to, the I-Stop system will be implemented within a year. AP Photo

In that time period, the amount of prescriptions written for oxycodone in New York City doubled. Per capita, that’s enough prescriptions for one in eight New Yorkers. On Staten Island, where the most prescriptions were filled, on a per capita basis, it’s as if 28 percent of the borough’s population are taking the painkiller; make that 33 percent on painkillers if you add prescriptions for hydrocodone — the active ingredient in drugs like Vicodin and Lortab — according to the city’s special narcotics officer, Bridget Brennan.

Between the increase in the number of addicts being treated for addiction to these pills, a spike in overdoses, major pill busts in recent years and a deadly pharmacy robbery on Long Island, regulators say it’s clear that too many people who don’t need these medications are gaining access to them in large quantities, and often selling them on the street.

The Dilemma for Doctors

“Part of the bill incorporates an electronic medical record, and we’re trying to get all physicians on board with electronic prescribing because there’s less chance of a script getting changes between physician and pharmacy,” said Dr. Neil Nepola, a family physician with a practice on Staten Island, and president of the New York State Academy of Family Physicians.

Nepola, like many doctors who prescribe pain medication, thinks mandating the e-prescription database is a good thing, but that doing it, especially with the real-time requirement, before the technology is perfected by December, 2014, poses serious problems.

“The problem with the system is that it puts a burden on physicians to enter prescriptions into the registry. It takes anywhere from three to 10 minutes for each patient, so when you’re evaluating and treating a lot of patients that’s a lot of time lost,” said Nepola.

According to Nepola, the Attorney General’s office already has a good idea of who the regular “doctor shoppers” are, but law enforcement hasn’t done enough to crack down on those people.  Instead, the obligation to act as enforcers is being put on the doctors.

“That’s a problem because it puts a barrier between patient doctor relationship. If I’m concerned you’re abusing a prescription and I’m trying to wean you off of it, then I’m being scrutinized,” said Nepola.

The result, he adamantly believes, is that a huge number of primary care physicians who might only fill between 10-20 prescriptions a day, will simply stop prescribing them. Not only will they stop prescribing oxycodone, they’ll stop prescribing hydrocodone, which the I-Stop bill will change to a Schedule II drug. This means patients will have to get a new prescription every time they run out, instead of getting automatic refills for a set period of time.

Instead of getting their medicine from their primary care physicians, Nepola believes, doctors will send pain patients to specialized pain management clinics, which might fill hundreds of prescriptions per day, the possible result being huge wait times for patients seeking relief from pain.

A Looming Shortage and Rise in Pain

Dr. Russell Portenoy is the chairman of pain management and palliative care at Beth Israel Hospital in Manhattan, which hosts a pain management clinic.

“What we’ve been trying to do for the past 25 years is talk about balance that says regulators and law enforcement people do need to address the problem of prescription drug abuse and diversion, but anything that’s done needs to address that these are crucial medications for legitimate pain patients,” said Portenoy.

He added, “The problem is course is that this legislation didn’t take into account input from the medical community that warns that it is too broadly written and too burdensome and falls into the kinds of regulation that historically have lead to a sharp reduction in prescribing, and that is going to lead to collateral damage. I’m anticipating that as this law gets rolled out there will be a great deal of distress stories, and many stories about patients who can’t get access to medicine.”

To give you an idea of how bad it already is for pain patients, in recent years many New York City pharmacies have stopped carrying OxyContin altogether, because they fear robberies and the hassle of addicts trying to get forged scripts filled.

Assemblyman Michael Cusick (D-Staten Island) who co-authored the I-Stop bill with State Senator Andrew Lanza (R-Staten Island) says they did work with the medical community, and that the potential problems are overblown.

“I’ve had a number of roundtables in my district, and I traveled down to Suffolk County and Eerie County and had roundtables there that included doctors, pharmacists and law enforcement — everyone affected. We tried to address everyone we could. The majority of pharmacists I have spoken to, particularly down in Staten Island, welcome this,” said Cusick. He added that the real-time requirement doesn’t mandate doctors to enter prescriptions into the database the very second they write them, but within a reasonable time, or a few hours.

Portenoy’s own department will be exempt from the I-Stop requirements because it also offers a hospice program for patients. But he and Nepola are both very concerned that I-Stop is not addressing the problems, and they’re very worried about the consequences for their industry. As part of a consortium of medical organizations, teamed up with the Medical Society of the State of New York, they helped draft a series of recommended improvements to the regulations.

Besides the issue of the real-time requirement being implemented before the e-prescribing database is perfected, Portenoy sees a number of additional problems:

• I-Stop doesn’t take into account the relationship between doctor and patient, the type of medication being prescribed or the patient’s history. For instance, a primary care physician who has known a patient for 25 years is subject to the same regulations as a pain clinic physician who is seeing a patient for the first time. Someone with a back injury being prescribed a single bottle of hydrocodone is treated the same as a cancer patient who needs regular doses of oxycodone.

• The bill calls for increased education for doctors, but Portenoy thinks the education requirement is ill-defined. The consequence, he said, is that primary care physicians might not have a good idea how to check for the warning signs of addiction, which pain clinic specialists are likely to have more expertise in. On a related note, the bill doesn’t have any requirements for determining a patient’s risk of addiction, like their history of drug and alcohol abuse and family background.

• The bill only mandates physicians and pharmacists in New York State to check the electronic database for their patients’ prescription histories within the state. According to Portenoy, someone could easily still doctor shop by going to pharmacies in neighboring states like New Jersey and Pennsylvania.

Who’s an Addict?

“Our pain practice sees thousands of patients and most of those patients are characterized by chronic pain, and among those patients referred to a pain specialist group, the risk of abuse is very high. It could be as high as 30 or 40 percent. That’s different from addiction,” said Portenoy.

“Addiction is a genetically determined medical disorder that’s distinct from, but related to abuse, and it’s different from tolerance and withdrawal. How many patients are addicts? That is relatively low. How many patients are engaging in drug abuse? How many are using alcohol or marijuana, or doctor shopping? It’s relatively high,” Portenoy said.

The distinctions are significant. Tabloid stories of celebrity prescription addicts suggest that most addicts started off as patients but simply lost control.

However, a 2008 study by the Miami School of Medicine found that 96 percent of people who were prescribed opioid medications did not become addicted to them.

Another study of 28,000 people conducted by the Treatment Research Institute in Pennsylvania found that 78 percent of people in rehab for prescription drug addiction had never been prescribed their drug of choice, and instead began buying them off the street.

And perhaps the most powerful testament to why pain patients need protections from over-regulation came from an ECRI Institute study, which found that only 0.27 percent of 5,000 patients prescribed opioid medications ever became addicted.

It seems clear that the crux of the problem lies in doctor shopping, and with people, mostly teens, who steal pills from their relatives’ medicine cabinets, not with patients who become addicted. As Portenoy explained, the fact that the e-prescription system isn’t required to link up to prescription systems in others states means there are some serious loopholes to preventing both of those problems.

What Are the Solutions?

In addition to the aforementioned issues and related solutions — improving education for doctors, improving the digital prescription database before instituting real-time prescription mandates, linking the system to other states, getting law enforcement officials to crackdown on doctor shoppers — Portenoy said the state needs to commit more seriously to the personalized nature of pain and addiction.

“The bottom line is that pain specialists now nationally endorse a concept called universal precautions, which means every patient being considered for chronic therapy needs to undergo an evaluation of risks looking for the potential abuse and addiction, and every patient’s treatment should be individualized,” he said.

Like the Hydra, New Problems with Effective Regulation

Suzanne Klier, a 35 year-old woman from Germany, with an 11-year heroin addiction, sits in one of the city-funded drug centers in Amsterdam where she can inject. The Netherlands has programs for opiate addicts to inject in sanitary conditions, and treatment centers where they can be weaned off of their drugs rather than treated cold turkey or with methadone. AP/ Serge Ligtenberg

As MSNBC reported, when smaller towns have successfully cracked down on prescription opiate abuse, in many cases they’ve seen a very sudden increase in heroin overdoses from addicts who couldn’t get their pills, but found an easy substitute for their high.

Heroin is far cheaper than OxyContin. Whereas an 80 mg oxycontin pill generally runs between $60-80 on the street in New York City, a glassine stamp bag of heroin that delivers a similar high costs $10-20, depending on the quality. And it’s the wildly variant quality of street drugs that contributes to a boom in overdoses.

It seems like a no-win situation. Rehab is expensive, and methadone treatment has highly mixed results. However, a more radical form of treatment that involves work between doctors and addicts, rather than law enforcement officials and the criminal justice system, might be the most effective tool in reducing the problem.

A study released last May by the Canadian Medical Association found that opiate addicts who were slowly weaned off of their drugs of choice by a doctor were 40 percent less likely to abandon treatment than those being treated with methadone. While that method of treatment has long been used in Switzerland and the Netherlands, it’s not likely to be accepted anytime soon in the United States, where the war on drugs has cost $1 trillion over the past 40 years, according to the Associated Press.