New York State’s New System for Tracking Prescription Drugs

On June 19, 2012, one lone gunman entered a small pharmacy in Medford, Long Island.  Seven gunshots later, four people lay dead—killed at close range without signs of resistance.  Three days later, David Laffer and his wife, Melinda Brady, were arrested.  Laffer was charged with first-degree murder.  Melinda Brady, driver of the getaway car, was charged with third-degree robbery. 

The Long Island pharmacy massacre was not a robbery gone awry.  The pharmacy’s video surveillance revealed David Laffer stuffing bottles of prescription pills into a backpack.  More than 11,000 hydrocodone pills—prescription painkillers—were missing from the drugstore’s inventory.  A police search of Laffer’s apartment, minutes from the Medford pharmacy, yielded thousands of the stolen pills.  The Long Island pharmacy massacre was an extreme example of a drugstore robbery by prescription-drug addicts.

During the last decade, prescription-drug abuse has exploded across America while use of illegal drugs like heroine and cocaine has fallen significantly over this same period.  This epidemic closely parallels the explosion of prescriptions written by practitioners for controlled substances—in particular, opiate analgesics (or painkillers).  The U.S. population increased by only sixteen percent from 1997 to 2011, but the amount of oxycodone (another type of opiate painkiller) sold by pharmacies increased by 1,250 percent.  The number of deaths from painkillers increased from 4,000 deaths in 1999 to 16,651 deaths in 2010.  After 2009, such deaths surpassed motor vehicle accidents as the leading cause of accidental death in the United States.

Opiates provide a substantial medical benefit by effectively relieving crippling pain. The associated risks, however, are profound.  Opiates are highly addictive with a significant potential for abuse, especially to those with mental illness, depression, or a history of substance abuse.  The body not only develops psychological and physical dependence to opiates, but also requires the drug in increasing amounts to experience their effect and forestall withdrawal. Many individuals believe that painkillers are safe because doctors prescribe the drugs, pharmacists dispense them, and the prescription painkillers do not seem as threatening as injecting—or shooting up—heroin or snorting cocaine.

Many factors have contributed to the over-prescribing of opiates:  an increased emphasis on pain management by society as a whole; aggressive promotion of powerful but addictive drugs by pharmaceutical companies; and lack of expertise in pain management by some practitioners.  Medical professionals must balance the substantial benefits derived from painkillers with unnecessary over-prescribing to drug diverters.

Governmental efforts to achieve informed prescribing have principally relied upon prescription-drug monitoring programs.  In general, these monitoring programs are drug databases containing information about medication already dispensed to patients.  Since 1983, federal legislation supported the formation of state-based databases to track controlled substances prescribed to patients.  Monitoring programs alert prescribers of aberrant drug-seeking behavior by a patient, helping to identify patients who are doctor shoppers and drug diverters, as well as medical professionals engaged in over-prescribing.  The term doctor shopper refers to a patient obtaining controlled substances from multiple healthcare practitioners without the prescribers’ knowledge of the other prescriptions.

Before the Internet, prescription-monitoring programs were ineffective because of the inherent delay of paper reporting; the inaccessibility to the database during off-hours; and under utilization due to the voluntary nature of consultation with the database.  Even after the creation of readily accessible online databases monitoring programs remained ineffective.  Online programs were underfunded and rarely utilized by clinicians.  A study of monitoring programs in 2011 revealed that drug databases failed to make any impact on mortality rates related to overdose from prescription drugs.  Despite this, all states except Missouri currently have a monitoring program or have enacted laws mandating the development of a drug database.  At the time of the Long Island pharmacy massacre, however, only two states—Kentucky and West Virginia—legally required a prescriber to consult a patient’s prescription history before prescribing a controlled substance.

The new I-STOP Database

Shortly after the Long Island pharmacy murders, Attorney General Eric Schneiderman introduced the I-STOP Act to New York State’s legislature.  Championed by State Assemblyman Michael Cusick and Senator Andrew Lanza, both houses unanimously passed and Governor Andrew Cuomo signed the legislation on August 27, 2012.  New York became the first state to mandate that medical practitioners consult the drug database before prescribing controlled substances.  After Tennessee, New York also became the second state to mandate real-time reporting by pharmacists dispensing such drugs.  Additionally, pharmacists were granted access under I-STOP to consult the drug database.  The Commissioner of Health was made responsible for making the database more “secure, easily accessible . . . and compatible with the electronic transmission of prescriptions for controlled substances.”  In December 2014, New York will become one of the first states to transition from paper prescriptions to an electronic prescribing (e-prescribing) system for controlled substances.

New York’s former monitoring program, known as the Controlled Substance Information program (CSI), was created in 1973.  The State Bureau of Narcotic Enforcement operated the CSI program under the Department of Health.  Although the monitoring program was voluntary, practitioners were required to keep a record with sufficient justification for every controlled substance prescribed.

Drugs and other chemicals controlled under the federal Controlled Substances Act are classified into five distinct categories or schedules depending upon the drug’s acceptable medical use, abuse potential, and likelihood of causing dependency.  Schedule I substances are defined as drugs with no currently accepted medical use but a high potential for abuse.   As the drug schedule progresses from Schedule I to V, the abuse potential diminishes—thus, Schedule V represents drugs with the least potential for abuse.

Initially, the database was limited to data collected for Scheduled II controlled substances, but was expanded in 1989 and 2007 to include prescriptions for benzodiazepines (Scheduled IV) and then all controlled substances (Schedule II, III, IV, V), respectively.  In 2008, the Bureau of Narcotics Enforcement began to notify practitioners of potential prescription abuse by patients; in 2010, the monitoring program was made available to medical practitioners directly.

Under the program, pharmacies licensed in the State, but not medical practitioners, were required to transmit certain patient, doctor, and drug information for every controlled substance dispensed.  Pharmacies were mandated to report this information to the Bureau by the fifteenth day of the following month.  Pharmacies were thus not required to provide data in real-time to the program.  The information provided could lag behind by up to forty-five days and was thus inaccurate.

Physicians were not required to consult the program.  Accordingly, few practitioners utilized the system when prescribing a controlled substance.  New York State Health officials indicated that less than 1,000 doctors—less than three percent of all medical professionals—used the program in 2010.  After aggressively promoting the system only 2,061 prescribers used the database in 2011.

Under New York’s monitoring program, a “doctor shopper” was defined narrowly as “a patient prescribed a controlled substance by two or more practitioners and dispensed by two or more pharmacies within a one-month period.”  Drug diverters who did not expressly satisfy this definition of a doctor shopper, as for example, a patient who used only one doctor or only one pharmacy, were not covered.  Despite the narrow definition, pharmacists were required to report suspected drug diversion to the Bureau of Narcotic Enforcement, but access to the database was denied to pharmacists.  Pharmacists were thereby unable to realistically detect or report suspected drug diversion.  The Bureau was empowered to report suspicious prescription histories to practitioners but, since the system was voluntary, most prescribers were not registered to receive this information.

The new I-STOP program will end most of these deficiencies.  It mandates the creation of an online, real-time database for Schedule II, III, and IV controlled substances prescribed and dispensed in New York State.  Practitioners must consult the program to review a patient’s prescription history before prescribing a controlled substance.  Similarly, pharmacists must report the dispensation of such drugs to the database in real-time.  These provisions under I-STOP became effective on August 27, 2013.  Beginning December 2014, I-STOP will mandate prescribers to directly transmit prescriptions for controlled substances electronically to the database.

On August 27, 2013, the online database I-STOP became accessible by Internet to practitioners possessing a Health Commerce System account.  Medical professionals registered to practice in the State can obtain such an account online by simply providing a valid driver’s license.  Such an account was already required for practitioners to prescribe controlled substances in New York State.  This account grants a practitioner direct, secure access to an online database containing up-to-date prescription histories of controlled substances dispensed to patients.  The database is user-friendly and available twenty-four hours a day, seven days a week.

The database contains information related to all prescriptions, including those from out-of-state practitioners, for controlled substances dispensed during the prior six month in New York State.  Practitioners can access this information to determine if non-medical use of a prescription drug is occurring.

Patients suspected of doctor shopping can now be counseled and offered treatment options by practitioners immediately after the Registry is consulted.  The Registry would similarly identify those patients receiving multiple prescriptions legitimately, but at risk for complications from dangerous drug interactions.  Importantly, practitioners can search their own DEA numbers to readily discern if their prescriptions have been altered, forged or stolen by drug diverters.

Official prescription pads have increasing become the target of drug abusers and dealers.  A single eighty-milligram pill of OxyContin commands a street value of approximately $80 to $100.  A prescription for thirty pills can thus be worth as much as $3,000.  A stolen prescription pad, typically holding fifty prescription blanks, can net a drug dealer about $150,000.  Since 2008, approximately 1.4 million scripts have thus been stolen from several hospitals within the New York City Health and Hospital Corporation.  Most of these fake scripts, notably, were written for an opiate.

The database’s search feature can also identify drug diversion by unscrupulous or “drug-dealing” doctors who prescribe for profit, not medical reasons.

Through the Medicaid program, taxpayers have largely subsidized the enormous costs related to over-prescription by crooked doctors.  Each drug-dealing doctor prosecuted by the Medicaid Fraud Control Unit, represents a loss of more than $1 million to the state’s Medicaid program.  Prosecution and conviction of crooked practitioners, however, was nearly impossible before I-STOP since unscrupulous physicians could assert that they were fooled into prescribing controlled substances to drug diverters misrepresenting symptoms.  Mandatory consultation with the Registry before prescribing, however, proscribes assertion of this drug-dealing doctor defense.  Fraud perpetrated against the State and private health insurers by drug-diverting doctors will therefore be deterred under I-STOP.

Transition from paper prescription to e-prescribing for controlled substances, mandated in New York by December of 2014, will likely eliminate drug diversion by alteration, forgery, and theft of paper prescriptions altogether.  Prescription transactions for such drugs will be transmitted in a secure, encrypted manner directly to the pharmacy for the intended patient in the intended dose and quantity.  Additionally, e-prescribing will minimize medication errors associated with handwriting, enhancing overall patient care.

At the time of the 2012 Long Island pharmacy massacre, the state’s existing drug-monitoring program revealed that David Laffer and his wife obtained numerous prescriptions from dozens of doctors for more than 12,000 painkiller pills over the preceding four years.  The couple obtained about one-third of that total (4,252 pills) in the six months immediately before the pharmacy murders.  Laffer then filled six prescriptions from five doctors for 200 pills in an eleven-day period eight days before the pharmacy murders.  Laffer filled one prescription for 60 pills at Haven Drugs just five days before he robbed this same pharmacy of more than 11,000 pills and murdered four people.

In the six months before the pharmacy murders, thirty of the thirty-six prescriptions that Laffer and his wife filled came from three area doctors.  The largest number were written by Dr. Stan Li, a full-time anesthesiologist at a large New Jersey hospital who also ran a pain management clinic in Flushing, Queens on Saturdays where he wrote more than 17,000 prescriptions in two and one-half years.  Laffer filled twenty-four prescriptions from Dr. Li for a total of 2,520 painkiller pills.  Several months after the Long Island pharmacy massacre, Dr. Li was charged with prescription sale and reckless endangerment after ten of his patients died from fatal overdoses of prescription drugs.

After the pharmacy murders, investigators readily obtained information on Laffer and Brady’s prescription history.  Pharmacists had appropriately collected and reported prescription data on the couple.  The prescription histories were also available to the dozens of doctors prescribing to the couple.  Apparently, none of these doctors consulted the drug database.  I-STOP now requires practitioners to consult the Registry before prescribing a controlled substance.  Only drug-dealing doctors would likely prescribe, despite I-STOP, to Laffer and his wife.  Legitimate doctors and pharmacists, consulting the database, would have likely reported the couple and anyone else helping them to obtain drugs.

In the first three days after I-STOP became effective, over 16,000 practitioners and pharmacists used the Registry created.  Users of the system conducted 162,719 searches statewide for 146,156 patients.  By comparison, Department of Health officials reported that only 2,216 practitioners—from a total of approximately 80,000—consulted the drug database in 2011.  Health officials reported that in the first three days of the Registry’s existence, a least 200 patients were discovered improperly attempting to obtain prescription drugs from multiple doctors.

The legislative purpose of I-STOP is “to promote the safe and effective use of prescription drugs and curb diversion and abuse of such drugs.”  The new law appears to be on a course to achieve its purpose.

By: Antonio Mendez, M.D. (Antonio Mendez is an evening student at New York Law School. A longer version of this paper, with footnotes, is on file with the Center for New York City Law).