How Govt. Crack Downs on Drug Prescriptions Can Backfire Spectacularly and Kill Privacy
If you get a prescription for Vicodin or Valium, Xanax or OxyContin, it almost certainly gets recorded in a government database. Almost every state now has a “prescription drug monitoring program" (PDMP), a registry listing every patient who was prescribed a drug scheduled in the federal Controlled Substances Act. According to the National Alliance for Model State Drug Laws, a federally funded nonprofit group that designs drug laws and urges states to enact them, 43 states have such programs, most established in the last decade, and six more are in the process of setting them up. The only exceptions are Missouri and Washington, DC.
Who gets access to that information varies from state to state, but it’s generally available to government health and licensing agencies, law enforcement, pharmacists, and doctors. Most programs send reports out when a patient gets more drugs than they deem likely for legitimate medical purposes. These reports are typically generated when someone obtains a prescription for a controlled substance from more than four to six doctors or fills one at more than four to six pharmacies within a 30-day period. Thirty states are authorized to provide such unsolicited reports to law enforcement.
Supporters of the programs say they are essential to fight the abuse of prescription drugs like OxyContin, which has risen dramatically since the late 1990s. Critics say they are ineffective, jeopardize patients’ privacy, and intimidate doctors who are trying to treat people in severe pain.
“The available evidence suggests that PDMPs are effective in reducing the time required for drug diversion investigations, changing prescribing behavior, reducing ‘doctor shopping,’ and reducing prescription drug abuse,” said a report issued in January by the Congressional Research Service. But it also said that there was limited research on the programs’ effectiveness, and that their unintended consequences might include “limiting access to medications for legitimate use or pushing drug diversion activities over the border into a neighboring state.”
“There is a risk of deterring patients with legitimate medical needs, and more seriously, a deterrent to doctors,” says Nathan Wessler, an American Civil Liberties Union staff lawyer representing four patients and one doctor in a suit challenging the Drug Enforcement Administration’s access to Oregon’s database. He believes the programs’ privacy provisions are too weak to protect patients.
The Popularity of Prescription Drugs
Prescription drugs, including opioid painkillers like OxyContin and Vicodin, tranquilizers like Xanax and Valium, and stimulants like Adderall, are the nation’s second most popular kind of illegal intoxicant. In 2011, the federal Substance Abuse and Mental Health Services Administration’s annual National Survey on Drug Use and Health estimated that 6.1 million Americans had used prescription drugs to get high in the last month. That was far behind marijuana, which had 18.1 million monthly users, but well ahead of cocaine, which had less than 1.5 million, and hallucinogens, methamphetamine and heroin, all under 1 million. (As these figures are based on responses to a government survey, they may be low, but the proportions roughly parallel the quantities seized by the Drug Enforcement Administration.)
More people die from overdoses of prescription drugs than from illegal drugs such as heroin, according to the federal Centers for Disease Control’s statistics. Of the 38,000 people who fatally overdosed in 2010, the CDC found, prescription drugs were a cause in 22,000, with opioids involved in about three-fourths of those deaths. The 36,000 overdose deaths in 2008 showed a similar pattern. On the other hand, according to the CDC figures, more than half the people listed as dying from prescription drugs had mixed them with other drugs such as heroin, cocaine or alcohol, and one-sixth were suicides.
The highest overdose rates are in Appalachia and the rural West, with New Mexico, West Virginia, Nevada, Utah, and Alaska, and Kentucky the top six states in 2008. Eleven states had more than 15 overdose deaths per 100,000 people, and New Mexico and West Virginia had more than 25. In Kentucky, the rate of drug overdoses more than tripled from 1999 to 2007, putting them second only to car accidents as the most common cause of unnatural death.
Why Is Prescription Drug Use On the Rise?
Both the legal and illegal use of prescription drugs has increased dramatically since the 1990s. The number of opioid painkiller pills prescribed quadrupled from 1999 to 2010, according to a November 2011 CDC report. About 9 million people a year get prescriptions for them, according to Food and Drug Administration statistics.
This comes from a mix of medical and commercial factors. On the medical side, doctors and other healthcare professionals in the 1990s moved to recognize pain as the "fifth vital sign”—in practice, making asking patients if they’re in pain as basic a procedure as checking their temperature, pulse, respiration rate, and blood pressure. By some estimates, between one-fourth and one-third of Americans suffer chronic pain such as arthritis or low back pain. In West Virginia, the poster-child state for prescription-drug abuse, more than one-sixth of working-age people are disabled, according to 2011 census figures.
On the commercial side, it came from the introduction and aggressive marketing of long-acting, extended-release painkillers such as OxyContin. Purdue Pharma, which introduced OxyContin in 1996, spent $200 million on promoting it in 2001 alone. In the drug’s first six years on the market, the company gave out more than 30,000 coupons making the first prescription free, and sponsored or funded more than 20,000 pain-related educational programs for healthcare personnel, according to a 2009 article in the American Journal of Public Health titled “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy.”
“Concern about undertreatment of pain,” says Sherry Green, head of the National Alliance for Model State Drug Laws, went forward without addressing drug abuse. She also blames direct-to-consumer drug advertising and that prevention efforts focused on illegal drugs and “did not pay enough attention to prescription drugs.”
The market for prescription drugs is significantly different from that for marijuana, cocaine, or heroin, as the supply is diverted from legal sources. According to a 2010 CDC survey, of people who used prescription painkillers non-medically that year, less than one-eighth got them from a dealer, and “nearly three-quarters received the drugs from a friend or relative—either for free, through a purchase, or via stealing the drugs.” More than half said they got them for free.
The main organized traffic is people getting them from doctors and pain clinics that prescribe indiscriminately, commonly known as “script doctors” or “pill mills,” most notoriously in Florida. In 2010, before Florida established its PDMP, the state was home to 90 of the 100 doctors who bought the most oxycodone, according to federal records obtained by the Orlando Sentinel. Florida also had the highest per capita rate of opioid prescriptions in the nation, according to the CDC. The situation has abated somewhat since the PDMP went into effect, says Sherry Green,
The Rise of Prescription-Monitoring Programs
California’s first prescription-monitoring program, established in 1939, was the nation’s first, says Green. There were 15 to 17 before 2002, and the rest have come since then, sparked by increasing concern over prescription-drug abuse and the availability of federal funds. Federal drug czar Gil Kerlikowske and the Office of National Drug Control policy are “making a very high-profile effort” to promote them, says Meghan Ralston, harm-reduction manager at the Drug Policy Alliance.
The programs are supported by a mix of public and private funds. The Harold Rogers Prescription Drug Monitoring Program, administered by the Bureau of Justice Assistance, has awarded 146 grants to 47 states to support the planning, implementation and enhancement of PDMPs since 2003.
Some states’ programs issue reports only when they are requested by doctors, pharmacists or law enforcement, but most have the authority to issue unsolicited reports. However, not every program that has that authority is using it, says Green. The reports are most commonly sent to prescribers and pharmacists, she says, and secondarily to state regulatory officials and law enforcement. Typically, the program sends the prescriber a letter suggesting that they go to the PDMP to get the patient’s prescription history and see “what pills the patient is getting in their hands.”
There is no way the system can automatically distinguish between someone in legitimate pain and someone who’s scamming to get drugs, she explains, so it’s used “to alert a physician about “suspicious circumstances.”
“This is an information tool,” she says. “It can’t be used to make a final determination.”
Depending on their state’s law, the programs can also provide information to Medicare, Medicaid, state insurance programs, parents of a minor child, county coroners, mental health and drug abuse professionals, grand juries, and workers’ comp specialists.
The federal National All Schedules Prescription Electronic Reporting Program, established in 2005, requires an unsolicited report “when an individual has filled six or more controlled substance prescriptions of the same drug class, from six or more different prescribers, or six or more different pharmacies in a state, within a one-month period.” The federal government is also planning to use electronic health data to send warnings or drug histories of “patients at risk” to pharmacists and doctors.
Most states and the federal government allow law enforcement access to prescription databases if they have an active investigation. A smaller number require a warrant, subpoena, or probable cause. In Vermont, police and prosecutors can only receive information from a professional licensing board. In Pennsylvania, they have to ask the state attorney general for access, and Nebraska’s program is voluntary.
In Massachusetts, the Boston Globe reported in January, local police, prosecutors, and the DEA will have access to the state database if they have an open investigation. Ironically, that policy was instituted after budget cuts eliminated the state police unit investigating drug diversion.
West Virginia in January announced plans to upgrade its database, which has more than 30 million entries, and develop criteria to search for suspicious users and doctors. Access is currently limited to 15 state police officers and regional drug task forces; a state police official told legislators that “they have to have a reasonable suspicion to run someone’s name,” and that wide-open access would lead to legitimate patients and doctors being targeted, the Charleston Gazette reported.
Kentucky’s May 2012 law mandates that all prescribers must create a profile for each patient and check the database before writing or refilling a prescription. Law enforcement needs an “open investigation” but not a warrant to get information.
Reports from KASPER, the Kentucky All Schedule Prescription Electronic Reporting System, show all scheduled prescriptions for an individual over a specified time period, as well as the prescriber and the dispenser. The data is also available via the Web. The program states that it is designed to be “a source of information for practitioners and pharmacists” and “an investigative tool for law enforcement,” and is not intended to “prevent people from obtaining needed drugs” or “decrease the number of doses dispensed.”
New York’s program, the Internet System for Tracking Overprescribing (I-STOP), is possibly the strictest in the nation. The law, signed by Gov. Andrew Cuomo last August, is the first to require doctors to review patients’ prescription history before they issue a new prescription for painkillers, and pharmacists to check the database before they dispense them. It also makes New York the second state to have pharmacists report prescriptions as soon as they are filed, and it mandates that by the end of 2014, all prescriptions for controlled substances must be dispensed electronically.
Painkiller prescriptions in New York increased by almost six million between 2007 and 2010, from 16.6 million to 22.5 million, according to a March 2012 report by state Attorney General Eric Schneiderman. Pressure to "do something" rose after a prescription drug addict killed four people while sticking up a drugstore on Long Island in June 2011.
Doctors and pharmacist groups in both Kentucky and New York opposed the legislation, citing administrative difficulty and patient privacy. Last July, Lexington emergency-room physician Dr. Steven Stack told Kentucky legislators that the law needed to be changed, because it “will restrict access by legitimate citizens to much needed relief of pain and suffering,” the Lexington Herald-Leader reported. He said an 80-year-old woman who comes to the emergency room with a broken wrist “doesn’t need a KASPER report” or extensive counseling to get pain medication.
Privacy and Deterrents
Only seven states—Colorado, Kansas, Minnesota, Oregon, Utah, Vermont, and Virginia—require doctors and pharmacists to inform patients that their PDMP information may be accessed.
The programs protect privacy by a combination of programmatic, technological and legal safeguards, says Sherry Green. All information is confidential, not covered by open-government-records laws, and unauthorized disclosure is usually a felony. Users need passwords to get access to the database; doctors need a medical license, and law enforcement needs at least “an active investigation” and usually a case number, she says. “They cannot use the PDMP to initiate an investigation.”
“There will be tens of thousands of people who will be improperly investigated,” Meghan Ralston responds. The program, she says, “seems set up to go after the little fish.” Someone going to six doctors and “lying about shoulder pain” to get one, two, or three months worth of painkillers from each is still getting only a few hundred pills, she adds. And while it may be happening, she says, she’s never seen anything about law-enforcement officers being certified to handle medical records under the Health Insurance Portability and Accountability Act of 1996’s privacy provisions.
“There’s a general privacy concern when the government’s accumulating large quantities of sensitive data,” says the ACLU’s Nathan Wessler. For one, he says, government data is routinely compromised. In 2012, hackers took 3.6 million people’s Social Security numbers and almost 400,000 tax payment records from South Carolina’s Department of Revenue, and Wisconsin’s accidentally posted the Social Security and tax identification numbers of more than 110,000 people and businesses on the Web.
Even in states that require a warrant or probable cause for law enforcement to get access to the database, the federal government can override those restrictions. Federal law requires only that a search be for information “relevant or material” to an ongoing investigation.
Oregon’s PDMP, established in 2011, requires law enforcement to have a court order based on probable cause. Last year, when the DEA subpoenaed the records of every prescription one doctor wrote for drugs in Schedules II, III, and IV during a six-month period, it refused to turn them over without such an order. In August, the U.S. Attorney’s office in Portland asked a federal court to rule that the looser federal law should apply. Assistant U.S. Attorney Leslie Westphal argued that the state law “would prevent the DEA from acquiring information through properly issued subpoenas when the investigation had not developed probable cause.” Magistrate Judge Paul Papak ordered the state to turn over the records.
The state is now suing to prevent the DEA from doing that again, and the ACLU is trying to intervene on Fourth Amendment grounds. Wessler’s clients in that suit are four patients and one doctor, all anonymous. Two of the patients are men with prescriptions for testosterone who fear their female-to-male transgender status might be exposed. Another has to take Vicodin for any minor pain, because he has a genetic blood disorder and lesser painkillers like aspirin or Tylenol would interfere with his blood-thinning medications. The fourth is an elderly man who takes oxycodone and hydrocodone for kidney stones and clonazepam for anxiety, and doesn’t want it revealed that he has mental-health problems.
“Our clients have a serious interest in keeping that information private between them and their doctors,” says Wessler. “We’re challenging the DEA’s ability to go sorting through people’s medical records without proving probable cause in front of a judge.” An “ongoing investigation,” he says, is “such a wide, vague standard” to gain access to what “should be among the most protected information.”
The doctor in the suit was interrogated by FBI and DEA agents about his prescribing practices; he writes a large number of painkiller prescriptions because he specializes in end-of-life care and most of his patients are terminally ill. According to the ACLU’s brief, the agents asked about specific patients, and when the doctor refused to turn their records over, they threatened to get his license and prescribing privileges revoked.
“Even in situations where patients are experiencing dire and debilitating pain, many physicians and other medical professionals with prescribing privileges have become unwilling to issue a prescription for a medically necessary narcotic painkiller because they fear scrutiny by law enforcement,” the brief says. “This is because law enforcement investigations of physicians are time-consuming, invasive, and can seriously harm careers.”
Sherry Green believes it would be better to investigate people’s prescriptions based on the number of pharmacies they go to rather than the number of doctors they see, because “if you look at legitimate patients, they tend to go to multiple doctors.”
“People go to multiple doctors for very good reasons,” Wessler says. They might also have a legitimate reason to go to multiple pharmacies—for example, ones near their home, near their job, and out of town if they’re traveling.
He also fears the “creeping mission of these databases.” A state can create appropriate safeguards, but they could be eroded, or it might share information with another state that has weaker protections. The Department of Justice is pushing for more interstate sharing, and there is an overall drive to digitize medical records. He believes that a national record-sharing system is likely in the future.
In Oregon, he says, “the real effect may be on small practitioners who don’t have big institutional support behind them.”
In January, New York Mayor Michael Bloomberg announced that the city’s public hospitals would no longer prescribe more than a three-day supply of Schedule II drugs such as oxycodone or hydrocodone to emergency-room patients.
Prescription Drug Users Turn to Heroin
If the monitoring programs are effective at blocking access to prescription opioids, they could have an unintended side effect: some users will turn to heroin. Over the last year, there have been numerous reports of that happening in rural areas that traditionally have not had a heroin market, such as in Oregon, Kentucky and Ontario. Another factor is that in 2010, Purdue Pharma changed OxyContin’s formula to make it harder to crush so it could be snorted or injected.
“There have been reports of increased heroin arrests in Kentucky, but we do not have any data or statistics on those arrests,” says Beth Crace Fisher, a spokesperson for the state Cabinet for Health and Family Services.
“You can’t push down on one side of that balloon and not expect the other side to blow up,” says Meghan Ralston. “This is not a perfect world. A certain percentage of the population is going to use drugs.”
She calls the monitoring programs “a really misguided effort rooted in some sincere desire.” The DEA touts them as a way to identify addicts and get them into treatment, but “there’s no evidence that any of that’s occurring.” California’s program has been in place for years, she says, but the state’s overdose rate is still rising.
The whole notion of preventing addiction through databases, she concludes, is “absurd. It’s theater. It’s designed to show that the government is doing a lot.”
She says she’s not suggesting “a free-for-all with pills raining down,” but if someone is addicted to OxyContin and going to a doctor fraudulently, she asks, isn’t it better that they get it from a doctor than from the black market? Are pharmacists supposed to refer them?
Similar efforts in the past have forced drug users to the black market. The Harrison Narcotics Act of 1914, which prohibited use of opioids without a prescription, left unresolved whether it was legal for doctors to prescribe them simply to prevent an addicted patient from withdrawing, but since the 1920s, law enforcement has interpreted that it was prohibited. And until the 1970s, most of the amphetamine supply was diverted pharmaceutical pills or prescribed by doctors with varying degrees of legitimacy. Tougher drug laws eliminated those sources, and since 1980, the market has been dominated by homemade or imported methamphetamine.
Educational programs like those used to discourage cigarette smoking would likely be more effective at reducing drug abuse, Ralston says. If the government is serious about using these databases to identify people with drug problems, she adds, why not give those people free methadone maintenance, rehab, mental-health counseling, job training, and childcare?
“We’ve never done that,” she says.
Green largely agrees with that last idea. She calls pill addicts turning to heroin “the next big issue.”
“As a nation, we haven’t really come to grips with the problem,” she says. “If you start cutting off the supply, they’re understandably going to look for anything they can get their hands on.
“We have to get serious,” she continues. “We’ve never provided the necessary treatment resources to prevent them from turning to heroin. If we don’t, we just end up shifting the addicted population to different drugs. We don’t adequately fund treatment resources.”
In New York, according to Attorney General Schneiderman’s report, the state spends more than 10 times as much on arresting, prosecuting, and incarcerating drug users and dealers as it does on treating addicts.