Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion
Published: 2002-05-17T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: Prescription drug diversion is the channeling of pharmaceuticals for illegal purposes or abuse. According to the Drug Enforcement Administration (DEA), increased prescription drug abuse and emergency room admissions, as well as the theft and illegal resale of prescription drugs, indicate that drug diversion is a growing problem associated with addiction, overdose, and death. All 15 state prescription drug monitoring programs (PDMP) collect information about the prescribing, dispensing, and use of prescription drugs and distribute it to medical practitioners, pharmacies, and state law enforcement and regulatory agencies. However, the programs differ in terms of objectives, design, and operations. In addition to helping law enforcement identify and prevent prescription drug diversion, program objectives also include education of the public, physicians, and pharmacists about the nature and extent of the problem, and medical treatment options for abusers of diverted drugs. The programs' designs vary by specific drugs covered and by the type of state agency in which they are housed. Some programs use the prescription data proactively to identify trends or patterns of use and to respond to law enforcement requests. Others use it only to respond to requests. States with PDMPs improve the timeliness of law enforcement and regulatory investigations. States considering establishing a PDMP, or expanding an existing one, face several challenges. These include educating the public and policymakers about prescription drug diversion and abuse and the benefits of a PDMP, responding to the concerns of physicians, patients, and pharmacists regarding the confidentiality of prescription information, and funding for program development and operations. National efforts to assist states in addressing illegal diversion have focused on providing guidance and technical assistance.

section_title: Letter
paragraphs: The increasing diversion of prescription drugs for illegal use is a disturbing  trend in the nation’s battle against drug abuse. Prescription drug diversion  is the channeling of licit pharmaceuticals for illegal purposes or abuse. It  can involve activities such as “doctor shopping” by individuals who visit  numerous physicians to obtain multiple prescriptions, illegal sales of  prescription drugs by physicians or pharmacists, and prescription forgery.  The most frequently diverted prescription drugs are those that are prone  to abuse, addiction, and dependence, such as hydrocodone (the active  ingredient in Lortab and many other drugs), diazepam (Valium),  methylphenidate (Ritalin), and oxycodone (the active ingredient in  OxyContin and many other drugs). According to the Drug Enforcement  Administration (DEA), increases in the extent of prescription drug abuse  and in emergency room admissions related to prescription drug abuse, as  well as an increase in the theft and illegal resale of prescription drugs,  indicate that drug diversion is a growing problem nationwide. In 2000, the  most recent year for which data are available, about 9 million Americans  aged 12 and older reported using prescription drugs, including pain  relievers, tranquilizers, stimulants, or sedatives, for nonmedical purposes.  The abuse of illegally diverted prescription drugs is associated with  serious consequences, including addiction, overdose, and death.
Fifteen states currently operate prescription drug monitoring programs  (PDMPs) as a means to control the illegal diversion of prescription drugs.  PDMPs collect, review, and analyze prescription data from pharmacies.  They provide data and analysis to state law enforcement and regulatory  agencies to assist in identifying and investigating activities potentially  related to the illegal prescribing, dispensing, and procuring of prescription  drugs. Because of your interest in the issues of prescription drug diversion  and control, you asked us to address the following questions: (1) How do  the 15 PDMPs compare across states in terms of objectives, design, and  operation? (2) What benefits have state PDMPs produced? (3) What  challenges do states face in implementing and using PDMPs? (4) What  efforts are being made at the national level to address the illegal diversion  of prescription drugs?
To address the questions concerning the state PDMPs, we reviewed  information from DEA and the National Alliance for Model State Drug  Laws on the features of the existing programs. To gain a more in-depth  understanding of these programs and the challenges they face, we studied  the PDMPs in Kentucky, Nevada, and Utah. We selected these three  because they were the most recently established programs. We  interviewed PDMP administrators and stakeholders in these three states.  Although the stakeholders varied in each state, they included officials of  state medical and pharmacy associations, state attorneys general offices,  state drug enforcement agencies, state police, and a state medical  examiner’s office. We also spoke with officials from practitioner licensure  boards and state law enforcement agencies, as well as DEA  representatives. We also discussed PDMPs with officials from Purdue  Pharma L.P., the manufacturer of OxyContin and other prescription drugs.  To determine what activities are being pursued at the national level to  reduce illegal diversion of prescription drugs, we interviewed experts from  DEA, the National Alliance for Model State Drug Laws, the National  Association of State Controlled Substance Authorities, and the Bureau of  Justice Assistance in the Department of Justice, and reviewed pertinent  documents. We performed our work from October 2001 through April 2002  in accordance with generally accepted government auditing standards.
subsections: section_title: Background
paragraphs: The diversion and abuse of prescription drugs are associated with  incalculable costs to society in terms of addiction, overdose, death, and  related criminal activities. DEA has stated that the diversion and abuse of  legitimately produced controlled pharmaceuticals constitute a  multibillion-dollar illicit market nationwide. One recent example of this  growing diversion problem is the controlled substance oxycodone, the  active ingredient in over 20 prescription drugs, including OxyContin,  Percocet, and Percodan. OxyContin has become the nation’s number one  prescribed narcotic medication for treating chronic severe and moderate  pain. A single 40-milligram OxyContin tablet legally selling for about $4 is  worth about $40 on the illicit market. As of February 2002, OxyContin has  been involved in 464 deaths from prescription drug abuse, as reported by  DEA on the basis of medical examiners’ autopsy findings for 2000 and 2001  from 32 states.
Combating the illegal diversion of prescription drugs while ensuring that  the pharmaceuticals remain available for those with legitimate medical  need involves the efforts of both federal and state government agencies.  The Controlled Substances Act of 1970 provides the legal framework for  the federal government’s oversight of the manufacture and wholesale  distribution of controlled substances. The states address these issues  through their regulation of the practice of medicine and pharmacy.
subsections: section_title: Controlled Substances Act
paragraphs: The Controlled Substances Act of 1970 established a classification  structure for drugs and chemicals used in the manufacture of drugs that  are designated as controlled substances. Controlled substances are  classified into five schedules on the basis of their medicinal value and  potential for abuse, addiction, and dependence. Schedule I drugs— including heroin, marijuana, and hallucinogens such as LSD and PCP— have a high potential for abuse and no currently accepted medical use.  Schedule II drugs—including methylphenidate (Ritalin) and opiates such  as hydrocodone, morphine, and oxycodone—have a high potential for  abuse and may lead to severe physical dependence, but have a currently  accepted medical use. Drugs on Schedules III through V have medical uses  and successively lower potentials for abuse and dependence. Schedule III  drugs include anabolic steroids, codeine, hydrocodone in combination  with aspirin or acetaminophen, and some barbiturates. Schedule IV  contains such drugs as the anti-anxiety medications diazepam (Valium)  and alprazolam (Xanax). Schedule V includes preparations such as cough  syrups with codeine. All drugs but those in Schedule I are legally available  to the public with a prescription.
Under the act, DEA has the authority to regulate transactions involving the  sale and distribution of controlled substances at the manufacturer and  wholesale distributor levels. DEA’s Office of Diversion Control (ODC)  provides legitimate handlers of controlled substances—including  manufacturers, distributors, hospitals, pharmacies, practitioners, and  researchers—with registration numbers, which are used in all transactions  involving controlled substances. Registrants must comply with a series of  regulatory requirements relating to drug security and accountability  through the maintenance of inventories and records. Although all  registrants, including pharmacies, are required to maintain records of  controlled substance transactions, only manufacturers and distributors are  required to report their transactions involving Schedule II drugs and  Schedule III narcotics, including sales to the retail level, to ODC. The data  provided to ODC are available for use in investigations of illegal diversions  at the manufacturer and wholesaler levels. Although data are reported to  ODC regarding purchases by pharmacies, the act does not require the  reporting of dispensing information by pharmacies at the patient level to  ODC.
section_title: State Regulation of the Practice of Medicine and Pharmacy
paragraphs: State laws govern the prescribing and dispensing of prescription drugs by  licensed health care professionals. All states require that physicians  practicing in the state be licensed, and state medical practice laws  generally outline standards for the practice of medicine and delegate the  responsibility of regulating physicians to state medical boards. State  medical boards license physicians and grant them prescribing privileges.  In addition, state medical boards investigate complaints and impose  sanctions for violations of the state medical practice laws.
Every state requires resident pharmacists and pharmacies to be licensed.  The regulation of the practice of pharmacy is based on state pharmacy  practice acts and regulations enforced by the state boards of pharmacy.  The state boards of pharmacy are also responsible for ensuring that  pharmacists and pharmacies comply with applicable state and federal laws  and for investigating and disciplining those that fail to comply. All state  pharmacy laws require that records of prescription drugs dispensed to  customers be maintained and that state pharmacy boards have access to  the prescription records.
section_title: State PDMPs
paragraphs: PDMPs are designed to facilitate the collection, analysis, and reporting of  information on the prescribing, dispensing, and use of prescription drugs  within a state. An overriding goal of PDMPs is to uphold both the state  laws ensuring access to appropriate pharmaceutical care by citizens and  the state laws deterring diversion.
The first PDMP was established in California in 1940. The number of states  with PDMPs has grown only slightly over the past decade, from 10 in 1992  to 15 in 2002. (See fig. 1.) Nevertheless, PDMPs cover about 47 percent of  the nation’s population, about 47 percent of the nation’s DEA-registered  practitioners, and about 45 percent of the nation’s pharmacies.
The nationwide number of PDMPs has been changing. West Virginia  terminated its PDMP in 1998, and New Mexico in 2000. West Virginia has  taken steps to create a new PDMP, however. Legislation to establish a new  program, again to be operated by the state’s board of pharmacy, was  enacted and approved by the governor in March 2002. In addition, a  number of other states have enacted or are considering legislation to  establish a program. (See fig. 1.)
section_title: National Alliance for Model State Drug Laws
paragraphs: Since 1993, the Alliance has served as a resource center for states  interested in identifying legislative and program improvements in drug  abuse reduction and prevention. Each year since fiscal year 1995, the  Alliance has received a $1 million grant from the Department of Justice,  administered by the President’s Office of National Drug Control Policy.  These funds are used to identify legislative, policy, and program initiatives  to address the supply of, abuse of, and addiction to alcohol and other  drugs. The model laws cover a broad range of issues, including money  laundering, forfeiture, housing, education, treatment, prevention, and  intervention. The funds also support statewide model drug law summits  that serve as intensive needs assessments and planning vehicles for the  states. The Alliance has also sponsored a Prescription Monitoring Work  Group composed of representatives from pharmaceutical manufacturers,  state licensing boards for physicians and pharmacists, state attorneys  general, and administrators of state PDMPs.
section_title: PDMPs Vary in Objectives, Design, and Operation
paragraphs: The 15 PDMPs have a common goal of reducing prescription drug  diversion and abuse, but vary in their objectives, design, and operation. In  addition to helping law enforcement identify and prevent prescription drug  diversion, state programs may include education objectives to provide  information to physicians, pharmacies, and the public. Program design  also varies across states, in terms of which drugs are covered, how  prescription information is collected, and which agency is given  responsibility for the program. Additionally, methods for analyzing the  data to detect potential diversion activity differ among PDMPs. Finally, the  cost of the program varies according to differences in these design and  operational factors.
subsections: section_title: Program Objectives Include Education as Well as Law Enforcement
paragraphs: Although the primary objective of PDMPs is to assist law enforcement in  detecting and preventing drug diversion, states have also used the  programs for educational purposes. Programs assist law enforcement  authorities both by providing information in response to requests for  assistance on specific investigations and by referring matters to law  enforcement officials when PDMP evaluations reveal atypical prescribing  or dispensing patterns that suggest possible illegal diversion. PDMPs have  also been used to educate physicians, pharmacies, and the public about  the existence and extent of diversion, diversion scams, and the drugs most  likely to be diverted by individuals. Programs have provided educational  materials to physicians on ways to prevent drug diversion and to educate  their patients about the diversion problem. They have evaluated  prescribing patterns to identify medical providers that may be  overprescribing and inform them that their patterns are unusual. They  have also identified patients who may be abusing or diverting prescription  drugs and provided this information to practitioners. For example, PDMPs  in Nevada and Utah send physicians drug utilization letters containing  patient information that signal potential diversion activity, including the  number and types of drugs prescribed to the patient during a given time  period and the pharmacies that dispensed the drugs. PDMPs have also  provided physicians with information on addiction treatment options for  patients identified as drug abusers or diverters. For example, Nevada’s  PDMP encourages physicians to refer identified doctor shoppers to pain  management or drug treatment programs that can help them manage their  chronic pain more effectively or treat their addiction.
section_title: Program Designs Differ Across States
paragraphs: Program design varies across state programs, in terms of which drugs are  covered, how prescription information is monitored and collected, and  which agency is given the responsibility for the program. (See table 1.)
State programs vary in the controlled substance schedules they cover, in  part because of differences in available resources and other state-specific  factors such as levels of drug abuse. As shown in table 1, nine PDMPs  cover only Schedule II controlled substances, which have the highest  potential for abuse and addiction. Two states, Kentucky and Utah, cover  all schedules, and Nevada covers Schedules III and IV, as well as II.  Washington’s program is used as a disciplinary tool and covers a variety of  controlled substance schedules on a case-by-case basis for each  practitioner. Most experts agree that covering all schedules prevents drug  diverters from avoiding detection by bypassing Schedule II drugs and  switching to drugs in other schedules. Program officials in Kentucky and  Utah also told us that covering all schedules allows them flexibility to  respond if drugs on other schedules become targets for diversion.  Covering more than Schedule II drugs greatly increases the number of  prescriptions that must be reported to the state PDMP. This can require  additional resources to review and interpret the additional data and  conduct necessary follow-ups. These officials, as well as officials from  DEA and the Alliance, agree that comprehensive coverage of all schedules  offers the most effective monitoring program. However, the Alliance’s  work group recommended that each state determine the schedules its  program will cover.
Most PDMPs use electronic monitoring systems, in which pharmacies  transmit prescription data for covered drugs electronically to the  designated state agency or a private contractor at least once a month.  Experts agree that electronic systems make it easier for law enforcement  to identify drug diverters, reduce investigation time and paperwork, and  provide easier access to information. Recently, New York and Illinois  converted from paper-based to electronic programs, and Texas and  Michigan have recently passed legislation to convert their programs to  electronic systems.
Five states—California, Idaho, Michigan, New York, and Texas— supplement their electronic systems with state-issued paper prescription  forms to help prevent forgeries and counterfeits. These forms can be  either single or triplicate and are made available by the state to  prescribers. New York and Texas have recently switched or are in the  process of switching from triplicate to single forms. The single forms  include a number of safety features that prevent them from being  photocopied or scanned, such as watermarks. Kentucky requires  prescribers to use non-state-issued secure safety forms when dispensing  controlled substances.
States have assigned the administrative responsibility for PDMPs to  various state agencies and regulatory bodies. Most programs are  administered by a law enforcement agency, a state department of health,  or a state board of pharmacy.
section_title: A Few PDMPs Operate Proactively, but Most Operate Reactively
paragraphs: States use different approaches to analyzing the prescription information  they receive. A few states routinely analyze prescription data collected by  the PDMPs to identify individuals, physicians, or pharmacies that have  unusual use, prescribing, or dispensing patterns that may suggest potential  drug diversion, abuse, or doctor shopping. States refer to this as a  proactive approach to identifying drug diversion. Trend analyses are  shared with appropriate entities, such as law enforcement, practitioners,  and regulatory and licensing boards. In contrast, most state PDMPs  generally use the prescription data to respond to requests for information.  These requests may come from physicians or from law enforcement or  state officials based on leads about potential instances of diversion.  According to state program officials, most PDMPs operate in the latter  fashion because of the increased amount of resources required to operate  a proactive system.
section_title: Design and Operational Factors Affect Program Costs
paragraphs: The differences in program costs among all PDMP states reflect a number  of design and operational factors. In addition to the choice of controlled  substance schedules monitored, these factors include computer  programming choices, number and type of staff and contractors,  turnaround times and report transmittal methods, number and type of  requests, and number of reporting entities, such as pharmacies.
If the PDMP is electronically based, there are ongoing computer  maintenance and programming costs. If a private contractor collects the  raw data from dispensers and converts them to a standardized format, the  PDMP pays annual contracting costs for database maintenance. Kentucky  and Nevada privately contract with the same company to collect data for  their program database. Utah, in contrast, collects and maintains drug- dispensing data in-house, using its own software and hardware.
The number and type of staff a state chooses to operate its PDMP also  vary and affect program costs. Kentucky’s PDMP employs four full-time  and four part-time staff to help ensure the accuracy of its reports,  including a pharmacist-investigator who reviews each report before it is  sent. Nevada’s PDMP operates with one employee because a private  contractor collects the data. In contrast, Utah’s PDMP, with three full-time  employees and no private contractor, has one program administrator who  collects all dispensing data and converts them to a standardized format for  monitoring, and maintains the database. The two other staff answer  requests.
If the PDMP seeks to provide same-day responses to report requests, the  costs involved in returning the response to the requester may increase. For  example, Kentucky has spent up to $12,000 in 1 month for faxing reports.  PDMP officials from Kentucky, Nevada, and Utah estimated 3- to 4-hour  turnaround times for PDMP data requests, and all mainly use faxing, rather  than more costly mailing, to return the report to the requester. Same-day  PDMP responses may be preferable for physicians who want the  prescription drug history for a patient being seen that day, and for law  enforcement users who need immediate data for investigations of  suspected illegal activity.
As users become more familiar with the benefits of PDMP report data,  requests and the attendant costs to provide them may increase. In  Kentucky, Nevada, and Utah, usage has increased substantially, mostly  because of the increased number of requests by physicians to check  patients’ prescription drug histories. In Kentucky, these physician requests  increased from 28,307 in 2000, the first full year of operation, to 56,367 in  2001, an increase of nearly 100 percent. Law enforcement requests  increased from 4,567 in 2000 to 5,797 in 2001, an increase of 27 percent.  Similarly, Nevada’s requests from all authorized users have also  increased—from 480 in 1997, its first full year, to 6,896 in 2001, an increase  of about 1,400 percent.
Additionally, as a PDMP matures, the needs it addresses may change, and  operating costs may increase as a result. If users want PDMP reports to  reflect more timely information, dispensing entities would have to report  their data at the time of sale, rather than submitting data biweekly or  monthly, to capture the most recent prescription dispensing. If users want  to be alerted if a certain drug, practitioner, or pharmacy may be involved  in a developing diversion problem, PDMPs would have to initiate periodic  data analysis to determine trends or patterns. Such PDMP enhancements  would entail additional costs, including costs for computer programming,  and data analysis. Kentucky’s PDMP is currently seeking $1.4 million in  additional operating funds to meet costs related to increased PDMP usage  by all users, particularly physicians, and to be able to provide periodic  reports about state drug usage trends and possible diversion.
section_title: State Programs Have Helped Shorten Investigation Time and Reduced Illegal Drug Diversion
paragraphs: States with PDMPs have experienced considerable reductions in the time  and effort required by law enforcement and regulatory investigators to  explore leads and the merits of possible drug diversion cases. The  presence of a PDMP helps a state reduce its illegal drug diversion, but  diversion activities may increase in contiguous states without PDMPs.
subsections: section_title: Investigation Time and Productivity Have Improved
paragraphs: The ability of PDMPs to focus law enforcement and regulatory  investigators on suspected drug diversion cases to specific physicians,  pharmacies, and patients who may be involved in the alleged activities is  crucial to shortened investigation time and improvements in productivity.  States that do not have PDMPs must rely on tips from patients,  practitioners, or law enforcement authorities to identify possible  prescription drug abuse and diversion. Following up on these leads  requires a lengthy, labor-intensive investigation. In contrast, PDMPs  provide information that allows investigators to pinpoint the physicians’  offices and pharmacies where drug records must be reviewed to verify  suspected diversion and thus eliminates the need to search records at  physicians’ offices and pharmacies that have no connection to a case.
Prior to implementation of Kentucky’s PDMP, its state drug control  investigators took an average of 156 days to complete the investigation of  alleged doctor shoppers. Following the implementation, the average  investigation time dropped to 16 days. Similarly, Nevada reduced its  investigation time from about 120 days to about 20 days, and a Utah  official told us that they experienced an 80 percent reduction in  investigation time.
section_title: Programs Have Helped Reduce Availability of Abused Drugs
paragraphs: Officials from Kentucky, Nevada, and Utah told us that PDMPs have  helped reduce the unwarranted prescribing and subsequent diversion of  abused drugs in their states. In both Kentucky and Nevada, an increasing  number of PDMP reports are being used by physicians to check the  prescription drug utilization history of current and prospective patients to  determine whether it is necessary to prescribe certain drugs that are  subject to abuse. Law enforcement officials told us that they view these  drug history checks as initial deterrents—a front-line defense—to prevent  individuals from visiting multiple physicians to obtain prescriptions,  because patients are aware that physicians can review their prescription  drug history. For an individual who may be seeking multiple controlled  substance prescriptions, the check allows a physician to analyze the  prescription drug history to determine whether drug treatment appears  questionable, and if so, to verify it with the listed physicians. In Kentucky,  a physician can request a PDMP report the same day as a patient’s  appointment, and usually receives the patient’s drug history report within  4 hours of making the request. Kentucky’s PDMP typically receives about  400 physician requests daily, and can provide data current to the most  recent 2 to 4 weeks.
The presence of a PDMP may also have an impact on the use of drugs  more likely to be diverted. For example, DEA rank-ordered all states for  2000 by the number of OxyContin prescriptions per 100,000 people. Eight  of the 10 states with the highest number of prescriptions—West Virginia,  Alaska, Delaware, New Hampshire, Florida, Pennsylvania, Maine, and  Connecticut—had no PDMPs, and only 2 did—Kentucky and Rhode Island.  Six of the 10 states with the lowest number of prescriptions—Michigan,  New Mexico, Texas, New York, Illinois, and California—had PDMPs, and  4—Kansas, Minnesota, Iowa, and South Dakota—did not.
The existence of a PDMP within a state, however, appears to increase drug  diversion activities in contiguous non-PDMP states. When states begin to  monitor drugs, drug diversion activities tend to spill across boundaries to  non-PDMP states. One example is provided by Kentucky, which shares a  boundary with seven states, only two of which have PDMPs—Indiana and  Illinois. As drug diverters became aware of the Kentucky PDMP’s ability to  trace their drug histories, they tended to move their diversion activities to  nearby nonmonitored states. OxyContin diversion problems have  worsened in Tennessee, West Virginia, and Virginia—all contiguous non- PDMP states—because of the presence of Kentucky’s PDMP, according to  a joint federal, state, and local drug diversion report.
section_title: Challenges Exist in Establishing and Expanding State PDMPs
paragraphs: States that are considering establishing or expanding a PDMP face a  variety of challenges. One challenge is the lack of awareness of the extent  to which prescription drug abuse and diversion is a significant public  health and law enforcement problem. States also face concerns about the  confidentiality of the information gathered by the PDMP, voiced by  patients who are legitimately using prescription drugs and by physicians  and pharmacists who are legitimately prescribing and dispensing them.  Another challenge states face is securing adequate funding to initiate and  develop the program and to maintain and modify it over time.
subsections: section_title: Extent of Diversion and Abuse Is Not Always Recognized
paragraphs: One challenge faced by states attempting to control diversion and abuse of  controlled substances is a lack of awareness of the seriousness of this  public health and law enforcement problem. Nationally, prescription drug  abuse involves a multibillion-dollar illegal diversion market, results in  deaths of abusers, and is as significant a problem as abuse of illegal drugs.  In Kentucky, the state police alerted state officials, including the attorney  general and the governor, about the extent of the state’s prescription drug  abuse problem. A task force was established with state legislators and  representatives from law enforcement, public health, and education,  which recommended that the state establish a PDMP. About 3 years later,  the abuse and diversion of OxyContin in eastern Kentucky became a major  concern, prompting the governor to create an OxyContin task force. The  task force recommended enhancing the PDMP’s capability to identify  doctor shoppers by increasing the timeliness of data collection, analysis,  and dissemination through development of an online, real-time data entry  system for pharmacists. Another recommendation was to develop an  educational program so PDMP users, such as physicians, pharmacists, and  law enforcement officials, could better understand the system’s enhanced  capabilities.
section_title: Physicians, Patients, and Pharmacists Express Concerns About Confidentiality
paragraphs: Both physicians who legitimately prescribe prescription drugs and  patients who legitimately use them are concerned that the information  collected, centrally maintained, and monitored by state PDMPs may be  used inappropriately or compromised. All states, regardless of whether  there is a state PDMP, have the authority under their laws to conduct  investigations of the records of individuals alleged to be involved in  prescription drug diversion and abuse, including the records of prescribing  physicians and dispensing pharmacies. PDMPs, particularly those with  electronic databases, raise additional confidentiality concerns, however,  because their databases contain complete dispensing records that can  more quickly identify individual patients, physicians, and pharmacies and  provide an individual report on their prescription drug history. Physicians  are concerned that their prescribing decisions and patterns may be  questioned and that they could be investigated without sufficient cause.  Some physicians contend that patients may suffer because physicians will  be reluctant to prescribe appropriate controlled substances to manage a  patient’s pain or treat their condition. Patients are concerned that their  personal information may be used inappropriately by those with  authorized access or shared with unauthorized entities. Pharmacists have  also expressed concerns. In New Mexico, the Board of Pharmacy repealed  the administrative regulations necessary to operate the state’s electronic  PDMP following confidentiality concerns raised by some pharmacists who  were apprehensive they might be targeted for investigation based on the  volume of controlled substance drugs they dispensed.
Some states have attempted to address these concerns statutorily. For  example, some state laws to regulate controlled substances and to operate  a PDMP include health privacy protection provisions. In addition, states  with PDMPs generally have statutory and regulatory protections to limit  access and use of confidential health care data, as well as statutory  penalties for misuse. Under Kentucky’s electronic PDMP, for example, the  authorized users of its information are statutorily delineated, the knowing  misuse of the data can result in a felony conviction, and the PDMP itself is  statutorily accountable for ensuring that only authorized users receive its  data. Kentucky law also prohibits any person who receives PDMP data  from sharing that information with anyone else, unless required by a court,  and the Kentucky PDMP advises data recipients of this prohibition.  Nevada’s state law similarly protects the confidentiality of its PDMP  information by requiring a court order for disclosure to nonauthorized  entities. Also, Nevada’s Board of Pharmacy has legal authority to discipline  and fine an individual for violating the confidentiality law. For example,  the board brought legal action against a pharmacist who provided an  employer with prescription utilization information on a worker whom the  employer subsequently fired. The pharmacist was fined $2,000 and was  given probationary discipline.
section_title: Securing Program Funding Is a Critical Challenge
paragraphs: According to officials from the National Alliance for Model State Drug  Laws, the National Association of Drug Diversion Investigators, and the  DEA, securing program funding is a critical challenge faced by states that  choose to develop, maintain, or expand a PDMP. They add that funding  availability is crucial to states’ ability to establish and continue PDMPs.  Given a state’s particular funding availability and priorities, PDMP costs  can involve a major hurdle. According to state officials, the start-up costs  for the three most recent PDMPs were $415,000 for Kentucky in 1999,  $134,000 for Nevada in 1996, and $50,000 for Utah in 1996. Estimated  annual operating costs for these PDMPs varied from a high of about  $500,000 in Kentucky to $112,000 in Nevada and $93,000 in Utah. These  three PDMPs are supported by state funds and do not charge fees for  providing data reports to their users. In contrast, the West Virginia PDMP  was terminated in 1998 primarily because of a lack of state funding  support, according to an official of the state board of pharmacy, which  operated the program. The board had been required to fund the PDMP  through the revenue generated by its licensing and related fees, without  additional state funds, but was unable to sustain operation of both its  licensing and regulatory program and its PDMP through these revenues  alone.
section_title: National Efforts Have Focused on Providing Guidance and Technical Assistance
paragraphs: Efforts at the national level to assist states in addressing illegal diversion  have focused on providing guidance and technical assistance. The  National Alliance for Model State Drug Laws has identified the key  features of a model PDMP and drafted a model law that states could adopt.  Both the Alliance and DEA have provided information to states about the  nature of drug diversion problems and guidance on how to deal with them.  DEA has also assisted states in initiating new PDMPs and improving  existing ones.
subsections: section_title: The Alliance Provides Models and Technical Assistance for States
paragraphs: The Alliance published the final report from its Prescription Monitoring  Work Group in February 2002. The report identified the key features of a  model PDMP. It recommended that PDMPs cover all schedules of  controlled substances, use some form of an electronic monitoring system,  safeguard the confidentiality of the prescription data collected, analyze the  data to provide information for law enforcement and medical  professionals, provide education to health professionals regarding the  monitoring system and pain management, and include an evaluation  component to assess its costs and benefits. Along with its work group  report, the Alliance provided a draft model state law.
The Alliance also facilitates communication between states that are  considering a PDMP and states that have programs in place, and provides  technical assistance to states on implementing its recommendations. It  reviews draft bills and provides information on current PDMP status,  trends, and legal matters to state legislatures. For example, the Alliance  work group recently stressed the need for states to assess the impact of  the HIPAA privacy provisions on state PDMPs.
section_title: DEA Has Assisted States in Dealing with Drug Diversion and Abuse
paragraphs: Since the 1980s, DEA has been supportive of state PDMP efforts to detect  and prevent illegal diversion of prescription drugs at the retail level. DEA’s  aid has been largely in the form of providing technical assistance to states  that are seeking to reduce diversion and abuse, and only recently in the  form of making start-up funding available to states.
Historically, DEA has routinely supplied educational materials to  practitioners, dispensers, and the general public on drug diversion. It has  also provided states with computerized information and intelligence on  the distribution of certain controlled substances and coordinated major  investigations. In addition, DEA has served as a program resource for  states seeking assistance with developing PDMPs and drafting and  promulgating regulations.
Over the past 11 years, three states have obtained federal funds to initiate  PDMPs: Kentucky (1998), Massachusetts (1992), and Oklahoma (1991).  More recently, additional funding has been made available for grants to  states that are planning to start a PDMP or expand an existing program.  Two million dollars in grants from the Department of Justice’s Bureau of  Justice Assistance is to be administered jointly with the DEA. DEA and  the Bureau of Justice Assistance designed the grant program to allow  states with legislation or regulations for a PDMP program in place or  pending to apply for funding. There are also grants available for states  with existing PDMPs to improve program capabilities through enhanced  technology. According to DEA, seven New Program Grants of $180,000  and two Enhanced Program Grants of $220,000 will be available. Several  states have expressed an interest in applying for the grants because of  their increased awareness of drug diversion.
section_title: Concluding Observations
paragraphs: Illegal diversion and abuse of prescription drugs and the associated  criminal activity are growing problems in many states. Prescription drug  monitoring programs offer states a more efficient means of detecting and  deterring illegal diversion. These programs provide state health care  licensing and regulatory agencies and law enforcement with quick access  to comprehensive information on the prescribing, dispensing, and  purchasing of controlled substances that are most likely to be targets for  diversion.
Although state PDMPs have aided investigators and helped to reduce  doctor shopping, the number of states with PDMPs has grown only slightly  over the past decade, from 10 in 1992 to 15 in 2002. A lack of awareness of  the magnitude of the problem, concerns about confidentiality on the part  of patients, physicians, pharmacists, and legislators, and difficulty in  accessing funding have kept the numbers of PDMPs low.
Cooperative efforts at the state and national levels are seeking to  overcome these challenges and increase the number of states with  programs. For states considering establishing PDMPs, the report by the  Alliance’s Prescription Monitoring Work Group provides a useful roadmap  of the critical factors each state needs to consider in order to create an  effective program. Moreover, the $2 million in grants available from the  Bureau of Justice Assistance, and to be administered jointly with DEA,  provides states with a potential source of funding to start a PDMP.
section_title: Agency Comments
paragraphs: We obtained comments on a draft of this report from DEA, the Alliance,  and state PDMP officials in Kentucky, Nevada, and Utah. In general, they  agreed with the report and thought it provided useful information on state  drug monitoring programs. They also provided technical comments, which  we incorporated where appropriate.
As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the Attorney  General of the United States, the Administrator of the Drug Enforcement  Agency, and others who are interested. We also will make copies available  to others upon request. In addition, the report will be available at no  charge on the GAO Web site at http://www.gao.gov.
If you or your staffs have any questions about this report or would like  additional information, please call me at (202) 512-7118. Another contact  and key contributors to this report are listed in appendix II.
section_title: Appendix I: Key Features of Selected State Prescription Drug Monitoring Programs
paragraphs: This table summarizes the key features of the state prescription drug  monitoring programs (PDMPs) in Kentucky, Nevada, and Utah.
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: In addition to the above, Robert Dee, Preety Gadhoke, Opal Winebrenner,  Roseanne Price, and George Bogart made key contributions to this report.