This summer, New York state passed legislation that aims both to prevent patients from doctor-hopping to stock up on prescriptions and to deter doctors from overprescribing controlled medications. The rest of the nation may emulate the new law, but the data that is supposed to be the backbone of the policy may very well be insufficient. Instead of reducing prescription pill abuse, these new regulations may prevent the people who need meds from getting them.
On June 11, New York State Governor Andrew Cuomo signed off on the I-Stop bill, which will require doctors to check a patient's medical history in an electronic database before prescribing Schedule II, III, IV and V drugs by summer of 2013.
It covers all the pills you could potentially take either to cope with a crippling medical condition or to party with: oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin, Lortab), the vast family of benzos (Xanax, Klonopin) and most amphetamines (Adderall, Ritalin).
While most states, including New York, already have these electronic databases, New York is the first to require doctors to actually check them before prescribing, and then report the new prescription into the database immediately after writing it. The goal is to help doctors know whether a patient has been going from doctor to doctor in search of multiple prescriptions, and also to prevent doctors from overprescribing.
Overprescribing doesn't mean that a doctor is handing out unnecessary prescriptions; it means that a doctor is prescribing a patient more pills than they really need. Problems can occur when a patient ends up with extra pills sitting in the medicine cabinet.
New York State Attorney General Eric Schneiderman called it a model for other states to adopt. It probably will be.
Since prescription drug abuse became a national epidemic, states have been rapidly trying to fnd a model to reduce overdose deaths, and New York is the first state to really take on the problem at its source in an aggressive way, much to the chagrin of many doctors.
"The trend is to move to real-time reporting of prescriptions," said Peter Ashkenaz, a spokesperson for the U.S. Department of Health's Office of the National Coordinator for Health Information Technology, which is currently helping Ohio and Indiana implement a prototype to grant real-time access to their electronic databases.
That said, New York's new law is very much a prototype. Little is known about how effective it will be or what negative, unintended impact it's going to have, and for that reason it's both fascinating and worrisome. That so little is known is partially because the one organization comparing different states' prevention techniques hasn't released the findings of its seven-year-long research project. It's also simply because of how uncharted this regulatory territory is in the United States.
To really understand the significance of New York's law and its impending adoption by other states, you need to look at its historical context.
In the late '90s and early '00s, prescription drug abuse was a decidedly rural problem in the American consciousness. Now, it's everyone's problem. A familiar narrative if you've been following drug news in the past five years.
Due in part to weak regulatory oversight, a lack of education among both doctors and patients and unscrupulous drug company practices, prescription pills surpassed meth as the national drug scourge. In New York City, new prescriptions for oxycodone doubled between 2007 and 2010, said the city's special narcotics officer, Bridget Brennan. By 2009, drug overdoses had replaced car accidents as the leading cause of death due to unintentional injuries, and the vast majority of those overdoses were due to pain pills like hydrocodone and oxycodone, according to CDC statistics.
Today, prescription drugs are the second most abused drugs in the nation. Marijuana still reigns supreme.
"I think it's one of the worst problems we've ever had in this country. You thought meth was bad? Well, prescription drug abuse is much worse," said Kevin Smith, director of governmental affairs at the National Alliance for Model State Drug Laws, an organization that advises policy makers and health officials in shaping effective state drug policy.
The National Alliance for Model State Drug Laws is one organization in a long list of private entities, government officials and nonprofits helping state governments figure out how to regulate prescription drugs.
Unlike the war on illegal drugs, the federal government can't try to shoot and incarcerate its way out of this epidemic. Remarkable advances in medicine over the past two decades have afforded millions of people better forms of relief from crippling pain and anxiety. These drugs will remain legal until laboratories come out with something to replace them with.
Because the practices of health officials are regulated mainly by state law, and because the specificities of drug problems vary widely from state to state, often as a result of their relationship to state law, state and federal health officials decided years ago that it would be best if the states managed their own plans to combat abuse.
Currently, almost every state is experimenting with some version of a fairly humane system designed to curb prescription drug abuse, and brand new enhancements to those systems are likely to become the norm in other states, even when they're untested.
If states prove successful in significantly reducing the number of prescription drug overdoses, without negatively impacting the lives of people who really need the drugs, they could influence the reshaping of the nation's policies for illegal drugs.
However, due largely to the complex way that these strategies are being coordinated between states, private organizations and the federal government with what pretty much everyone says is a limited funding stream against a new kind of drug epidemic, information about what is and isn't working is often slow to arrive.
There are also competing philosophies about where the problem stems from. The solid research that exists is often ignored.
For example, tabloid stories generally paint a portrait of the common prescription pill abuser as someone who was legitimately in pain but was transformed into the Limbaugh breed of junkie by their doctor. 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 started getting it through friends or family, or a dealer.
But whether it was through a dealer, the family medicine cabinet or a friend at a party, the pills ultimately came from a doctor.
There is no coherent national strategy, at least not one with any depth. But in 2011, the Obama administration released an action plan to combat prescription drug abuse, which advised states to set up educational programs for patients and doctors, empower law enforcement crackdowns on pill mills, create medical waste disposal programs that encourage people to keep old pills out of the medicine cabinet and monitor prescriptions. In many states, some version of each of these methods is currently in operation.
"Silver Bullet" for Ending Prescription Drug Epidemic
"Monitoring" means using a prescription drug monitoring program (PDMP). A PDMP is an electronic database of patients' prescription histories. It's supposed to tackle the abuse problem at the source.
The drug policy firm Carnavale Associates has called PDMPs the "silver bullet for ending the prescription drug epidemic."
A PDMP serves two aims. First, it is designed to prevent people from doctor shopping: getting multiple prescriptions for the same drug from multiple doctors. The second is to give the law enforcement and medical communities a better idea of which doctors are overprescribing.
PDMPs already exist in New York and 42 other states and laws have been passed that will require them to be created in every remaining state except for Missouri. Oklahoma was the first state to create an electronic PDMP back in 1991. After it became clear that the prescription drug problem had become a national problem, other states followed Oklahoma's lead.
Each state's PDMP is different. Many are voluntary and don't require doctors or pharmacists to actually use them at all. As of January, Oklahoma requires pharmacists and doctors who actually dispense the drugs to report a prescription into the database immediately after filling the prescription, but doesn't have the same mandate for the prescriber.
Oklahoma's is managed by law enforcement, New York's is managed by the health department. Many can't even be accessed by law enforcement without a warrant.
The Justice Department encourages states to share their PDMP data with one of two interstate hubs designed to allow people looking at the database in one state to see if a patient has prescriptions in another state. These are both new tools, and because different kinds of agencies have access to the PDMP from state to state, many pharmacies and physicians don't share information with these interstate hubs.
"Many years ago it was decided that it would be better to allow states to manage their own individual databases, because they could be more responsive and gather information to give back to people in their state," said Sherry Green, executive director of the National Alliance for Model State Drug Laws.
She explained that while the states are responsible for implementing their own PDMPs, the federal government still exerts some control because it controls much of their funding.
"There are two grant programs from the federal level. One is through the Justice Department and one is through the Health Department, and both give grants to state programs. If there are certain things they want states to do they'll incentivize them through the grant program," said Green.
The source of these two funding streams, one medical and one law enforcement-based, mirror the dual role of the PDMPs themselves -- as both a crime-fighting tool against doctor-shopping and a public health tool to prevent doctors from over-prescribing. The lines between the two are often blurred, which can be problematic for people dealing directly with prescription drug abuse and the researchers trying to understand the drug problem.
In regard to their role as a crime-fighting tool, PDMPs have one glaring defect: they give doctors and pharmacists days, often weeks, to input prescriptions into the system. In the meantime, someone looking to go to multiple other doctors still has a window in which to do it: the very problem that the real-time requirement in New York is designed to solve.
That's also the problem that Oklahoma's real-time requirement is designed to solve, but in a very different way. Just as the PDMPs themselves have spread to almost every state, real-time is the next level that's about to be tested across the nation.
New York's model, not Oklahoma's will almost certainly become the national strategy, because New York is the first state to take on the problem at the source, the doctor's office. For that reason doctors across America should take note of what's happening in the Empire State.
The Difference Between Oklahoma and New York
Oklahoma's state legislature passed the real-time law over two years ago, but the system didn't finally get up and running until January 2012. By that time, all 1,013 of Oklahoma's pharmacies were supposed to be reporting real-time data to the PMP, but only 300 actually were.
"The technology needs to catch up to the law. There are some medical clinics that haven't event got the electronics yet, most of the bigger ones certainly have. They're catching up to it," said Mark Woodward, spokesman for the Oklahoma Bureau of Narcotics.
It's too soon to tell whether Oklahoma's real-time requirement has had an impact on doctor-shopping, but the management differences between Oklahoma and New York shed light on the different philosophical approaches to prescription drug regulation.
In Oklahoma, the Bureau of Narcotics is in charge of managing the state's PDMP, unlike in New York, where it's managed by the Health Department.
"They both monitor Schedule II-V drugs. The big difference is the access and ability of the PDMP to be most useful to the health community. Oklahoma works extensively with their pharmacists. Truthfully, New York's requirement that prescribers access the database [as opposed to just reporting to it without checking a patient's history] is going to be more extensive," said Sherry Green.
Whereas New York's new law requires doctors to access the database before writing a prescription, and then immediately report the new prescription, Oklahoma only requires that pharmacists enter the prescription immediately after filling it. It doesn't address the problem of overprescription, only doctor-shopping. It doesn't put the burden on the doctors, it put the burden on law enforcement to go after people they suspect are doctor-shopping.
Should doctors police patients or should law enforcement? It's a rock and a hard place issue. While Oklahoma's solution is more akin to the traditional U.S. strategy of stopping drug abuse, New York's presents its own ethical dilemma.
MD or NYPD?
Some New York doctors say there are two related problems with the new requirements: 1) the system is too slow and will overburden them; and 2) the more fundamental problem: they're expected to police their patients, thus breaching the doctor-patient confidentiality agreement.
"The problem with the system [PDMP]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 Neil Nepola, a family physician with a practice on Staten Island, and president of the New York State Academy of Family Physicians.
The I-Stop law actually has two parts. The first is the real-time requirement by 2013. The second part of the law requires the State Health to implement a new, faster and more sophisticated electronic database by 2014.
Dr. Russell Portenoy, the chairman of pain management and palliative care at Beth Israel Hospital in Manhattan, believes these two parts of the bill are being rolled out in reverse order.
"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.
Portenoy says that few doctors or medical organizations were given an opportunity to offer input.
Nepola says that because state law enforcement has access to the PDMP, the attorney general already has a rough idea of who the doctor-shoppers are, but is essentially handing law enforcement's role over to the medical field. The balance is thrown off.
"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.
Both Portenoy and Nepola fear that many family-care physicians will simply stop prescribing drugs like hydrocodone and oxycodone. That, they said, could cause a huge number of people seeking prescriptions to turn to the already overburdened pain management clinics throughout the state.
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 members of the medical community in his district, and that the potential problems are overblown. Overblown or not, this conversation will inevitably replicated in other states. The question is whether other states will be willing to have a more in-depth dialogue with their doctors.
Oklahoma: A Law Enforcement-Based Approach
Of the two states with real-time requirements for their PDMPs, nobody knows which will have a greater impact. But past evidence suggests it could be New York.
Even though Oklahoma had the first electronic PDMP, the state currently leads the nation in prescription pill abuse, as in the amount of people popping pills to get high, according 2008-2009 data compiled by the National Survey on Drug Use and Health. At the same time, Oklahoma ranks ninth nationally in the percentage of its population who are prescribed prescription painkillers.
You could eke out a lot of different conclusions from these colliding facts, but the truth is nobody is certain why Oklahoma has such a high rate of abuse.
"I would say that our numbers would be even higher without the PDMP system. A lot of doctors have told us anecdotally that they're stopping people who come to them for prescriptions as a result of the PDMP," said Woodward.
He added, "I don't think Oklahoma is really unique. I don't think we're strides ahead of other states. Oklahoma and the entire country are seeing the same problem. We need to catch these people who are going from doctor to doctor to doctor. That's why the PDMP is so critical."
"In God we trust. Everyone else, bring data." - Michael Bloomberg
That anecdotal diagnosis is probably valid, but Woodward's prescription for it might not be. The limited research that's available says that PDMPs are indeed effective in reducing abuse, but that doctor-shopping is far less prevalent than the mass finger-pointing should warrant.
"Everybody gets hung up on doctor-shopping. Ronald Simeon's study basically shows that doctor-shopping is not that substantial. The real issue is the prescribing behavior of physicians whose culture is to overprescribe. They do that so they won't inconvenience the consumer, while at the same time adding to the inventory of these drugs," said John Carnavale, president of the public policy firm Carnavale Associates, which advises governments and other organizations on drug policies.
The study Carnavale referenced was created by researchers Simeone and Associates in 2006, a time when only 20 states had PDMPs. The study, "An Evaluation of Drug Monitoring Programs," found that the states with PDMPS have a lower probability of prescription drug abuse than states that did not, and that most people who abused prescription drugs got them from friends.
The CDC often highlights another study from 2009 that supports the latter conclusion. That study found that 55 percent of people who abuse prescription painkillers obtained them from a friend or relative, but only 17 percent got them through a doctor.
From these two bodies of research, you could infer that Oklahoma's requirement for reporting new filled prescriptions in real-time, which essentially only functions to to prevent doctor shopping, might not be that effective.
New York's requirements that doctors actually check a patients' prescription history and then report in real-time might not be that useful insofar as it's designed to stop doctor-shoppers.
But the added scrutiny on the doctors might actually cause more of them to reconsider the quantity of pills they're prescribing to each patient. Of course, this frustrates the hell out of doctors who don't over-prescribe.
Nobody is really sure. There hasn't been another study on the effectiveness of PDMPs since the Simeone study. And the Simeone study didn't differentiate between who has access to the PDMPs in different states. It did, however, find one major difference between two types of databases.
Curious Delays in Waltham, MA
"The evidence base is kind of slim. There is evidence, but a lot of it is observational. The elements that seem to improve their effectiveness includes issuing unsolicited reports," said Peter Kreiner, principal investigator at Brandeis University's PDMP Center for Excellence, a research institution dedicated entirely to studying the effectiveness of PDMPs.
That evidence came out of the Simeone study. A PDMP that issues unsolicited reports will analyze its own data, and if it finds any irregularities that might suggest a patient is doctor shopping or that a doctor is over-prescribing, it will automatically alert certain agencies. That could be law enforcement, doctors, the medical licensing board. It depends on the state.
A solicited report, on the other hand, would be released when an agency specifically requests certain information from the database.
Kreiner said that about half of the states with PDMPs issue solicited reports, and of that half, about two-thirds are programmed to issue unsolicited reports.
Both Oklahoma and New York's PDMPs issue unsolicted reports. Policy advisers need more specific data.
Kevin Smith from the National Alliance for Model State Drug Laws agrees with Kreiner that the evidence is slim, that the Simeone study is too outdated, too narrow in scope to give a real idea of which PDMPs work the best.
"It's not detailed enough. We just don't know enough yet because nobody has collected the data," said Smith. "We know of one university that's supposed to be, but we can't get that data."
That university happens to be Brandeis, specifically the PDMP Center for Excellence where Kreiner works, and which is funded through the Bureau of Justice Associates (a branch of the Justice Department) Harold Rogers grant, specifically designed to fund PDMP research.
Kreiner said that because the Center for Excellence get its funding via the Justice Department, it is required to measure the performance of the various PDMPs. However, the Center also gets its data through the Justice Department, which, in turn, gets its data from the states in the form of quarterly reports.
Kreiner said the PDMP Center for Excellence has been collecting this data for about seven years.
"Part of the issue is the quality of the data," said Kreiner. "As we've been putting together tables of the data, we often find anomalous values, and we have to go back to the states to correct it. Earlier than 2009 there were various issues with the data."
But people trying to advise state governments across the country about how to regulate prescription drugs aren't happy. Those people include John Carnavale, who assembled the data from the Simeone study and who sits on the Center's board. He said he believes that PDMPs are very effective, and he's urged the Center to package its data and make it publicly available.
"State legislators are going to be looking for things to cut, and these PDMPs could find their way on the chopping block. So I'm really anxious about that," said Carnavale.
Kreiner said that the Center will put out a report on it this summer or fall.
Smith said he's heard that something will be available within six weeks on three to four different occasions over the past year.
"The performance measures are intended to evaluate PDMP effectiveness, and they do that to some extent. Performance measures include how many solicited reports were distributed to different user groups, how many unsolicited reports, how many prescribers are registered to use the PDMP, how many prescriptions, "said Kreiner, before rattling off a lengthy list of other measures.
But, he added, "There are a lot of factors that affect what a PDMP does and its outcomes."
In other words, this data may not be as useful as Smith, Carnavale and Green would hope.
Toward Smarter, Not Easier Drug Controls
Julie Netherland is the deputy director for the New York branch of the Drug Policy Alliance, which advocates for alternatives to the war on drugs.
"It'll be interesting to see what happens in New York," she said of the I-Stop law, but argued that the state should make lifesaving treatments for overdose victims more widely available, and promote the state's new Good Samaritan law that grants people immunity from legal punishment if they call 911 when someone is overdosing.
Unless there's a sharp drop in drug overdoses in New York after the mandate goes into effect, everyone will have to wait until more research is published to have a better idea of how PDMPs should best be structured. Nevertheless, it's extremely likely that other states are already planning to follow New York's lead.
As those debates occur, meanwhile, we can glean an understanding of just how difficult the process of achieving a smarter, less brutal drug policy can be.
"I think people are still really grappling with what the appropriate regulations are. There are more and more Good Samaritan programs being created. Whether there's a coherent national strategy? I do think that the sort of attention and energy on the very real problem of prescription overdose and addiction is challenging most states and the federal government to think of more humane drug policy approaches," Netherland added.