Prescription Drugs: State Monitoring Programs Provide Useful Tool
to Reduce Diversion (17-MAY-02, GAO-02-634).
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
in 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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-02-634
ACCNO: A03382
TITLE: Prescription Drugs: State Monitoring Programs Provide
Useful Tool to Reduce Diversion
DATE: 05/17/2002
SUBJECT: Drug abuse
Pharmaceutical industry
Controlled substances
Monitoring
Law enforcement
Program evaluation
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GAO-02-634
Report to the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives
United States General Accounting Office GAO
May 2002 PRESCRIPTION DRUGS State Monitoring Programs Provide Useful Tool to
Reduce Diversion
GAO- 02- 634
Page i GAO- 02- 634 Prescription Drug Monitoring Programs Letter 1 Results
in Brief 3 Background 4 PDMPs Vary in Objectives, Design, and Operation 9
State Programs Have Helped Shorten Investigation Time and Reduced Illegal
Drug Diversion 15 Challenges Exist in Establishing and Expanding State PDMPs
17 National Efforts Have Focused on Providing Guidance and
Technical Assistance 20 Concluding Observations 21 Agency Comments 22
Appendix I Key Features of Selected State Prescription Drug Monitoring
Programs 23
Appendix II GAO Contact and Staff Acknowledgments 24
Tables
Table 1: Characteristics of State Prescription Drug Monitoring Programs 11
Table 2: Key Features of Selected State Prescription Drug
Monitoring Programs 23 Figure
Figure 1: Status of Prescription Drug Monitoring Programs, by State, April
2002 8 Abbreviations
DEA Drug Enforcement Administration HIPAA Health Insurance Portability and
Accountability Act of 1996 ODC Office of Diversion Control PDMP prescription
drug monitoring program Contents
Page 1 GAO- 02- 634 Prescription Drug Monitoring Programs May 17, 2002 The
Honorable James C. Greenwood
Chairman The Honorable Peter Deutsch Ranking Minority Member Subcommittee on
Oversight and Investigations
Committee on Energy and Commerce House of Representatives
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, 1 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. 2 The abuse of illegally
diverted prescription drugs is associated with serious consequences,
including addiction, overdose, and death.
1 According to the National Institute on Drug Abuse, addiction is a chronic,
relapsing disease, characterized by compulsive drug seeking and use and by
neurochemical and molecular changes in the brain, whereas physical
dependence is an adaptive physiological state that can occur with regular
drug use and results in withdrawal symptoms when drug use is discontinued.
2 1999- 2000 National Household Survey on Drug Abuse, Substance Abuse and
Mental Health Services Administration, Department of Health and Human
Services.
United States General Accounting Office Washington, DC 20548
Page 2 GAO- 02- 634 Prescription Drug Monitoring Programs 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 3 on the features of the existing programs. 4 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.
3 In this report, we refer to this organization as the Alliance. The
Alliance, a nonprofit association, is the successor to the President?s
Commission on Model State Drug Laws. 4 All references to state laws relating
to PDMPs were provided to us by the National Alliance for Model State Drug
Laws and were not independently verified.
Page 3 GAO- 02- 634 Prescription Drug Monitoring Programs All 15 state PDMPs
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, but the
programs differ in terms of objectives, design, and operations. In addition
to helping law enforcement identify and prevent prescription drug diversion,
a program?s objectives may include education of the public, physicians, and
pharmacists regarding the nature and extent of the problem and medical
treatment options for abusers of diverted drugs. With regard to design, the
programs vary primarily in terms of the specific drugs
they cover and the type of state agency in which they are housed. Some PDMPs
cover only those prescription drugs that are most prone to abuse and
addiction, whereas others provide more extensive coverage. In addition, most
programs are administered by a state law enforcement agency, a state
department of health, or a state board of pharmacy. Finally, some programs
use the prescription data proactively, to identify trends or patterns of
use, as well as to respond to requests from law enforcement officials,
whereas others use it only to respond to requests.
States with PDMPs have realized benefits in their efforts to reduce drug
diversion. These include improving the timeliness of law enforcement and
regulatory investigations. For example, Kentucky?s state drug control
investigators took an average of 156 days to complete the investigation of
an alleged doctor shopper prior to the implementation of the state?s
PDMP. The average investigation time dropped to 16 days after the program
was established. In addition, law enforcement officials in Kentucky and
other states view the programs as a deterrent to doctor shopping, because
potential diverters are aware that any physician from whom they seek a
prescription may first examine their prescription drug
utilization history based on PDMP data. Officials from DEA, the Alliance,
and state PDMPs told us that states considering establishing a PDMP, or
expanding an existing one, face several challenges. These include educating
the public and policymakers about the extent of prescription drug diversion
and abuse in their state and the benefits of a PDMP, responding to the
concerns of physicians, patients, and pharmacists regarding the
confidentiality of prescription information, and funding the cost of program
development and operations. Given a state?s particular funding availability
and budget priorities,
program costs can be a major hurdle. The start- up costs for the three most
recent PDMPs were $415, 000 for Kentucky, $134,000 for Nevada, and $50,000
for Utah. Estimated annual operating costs for these PDMPs varied from a
high of about $500,000 in Kentucky, to $150,000 in Utah and $112,000 in
Nevada. Costs in these three states vary because of differences Results in
Brief
Page 4 GAO- 02- 634 Prescription Drug Monitoring Programs in the PDMP
systems implemented, the number of pharmacies reporting drug dispensing
data, and the number of practitioners and law
enforcement agencies seeking information from the systems. (See app. I.)
National efforts to assist states in addressing illegal diversion have
focused on providing guidance and technical assistance. The Alliance has
provided a useful source of information for the development of recent state
programs. In addition to identifying the key features of a model PDMP, the
Alliance has provided a draft model law for states interested in
establishing their own PDMP. The Alliance has also provided technical
assistance to states in implementing the recommendations in the model
program. Funding has recently 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 are to be administered jointly with the DEA. DEA, the Alliance,
and the PDMPs in Kentucky, Nevada, and Utah reviewed a draft of this report
and in general agreed with its contents. Their technical comments have been
incorporated where appropriate.
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. 5 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. 5 Drug Enforcement Administration and the National Alliance for
Model State Drug Laws, A Closer Look at State Prescription Monitoring
Programs (http:// www. deadiversion. usdoj. gov/ pubs/ program/ rx- monitor/
summary. htm accessed September 17, 2001). Background
Page 5 GAO- 02- 634 Prescription Drug Monitoring Programs 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 6 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. 7 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. 8 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 6
Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970
(Pub. L. No.
91- 513, sect.sect. 100- 103, 84 Stat. 1236, 1242- 1284). 7 According to the
Kentucky PDMP administrator, the state has also chosen to regulate drug
manufacturers and wholesalers. 8 Some Schedule V drugs that contain limited
quantities of certain narcotic and stimulant drugs are available over the
counter without a prescription. Controlled Substances Act
Page 6 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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. 9
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. 9 The types of practitioners who prescribe drugs and
may be monitored by a PDMP vary among states. Physicians are the majority of
covered practitioners, but in most states many nonphysicians also have
prescribing authority, including physician assistants, dentists,
optometrists, podiatrists, veterinarians, and certain types of nurses, such
as nurse practitioners and advanced practice nurses. State Regulation of the
Practice of Medicine and Pharmacy
Page 7 GAO- 02- 634 Prescription Drug Monitoring Programs 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 10
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. 11 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.)
10 U. S. General Accounting Office, Prescription Drug Monitoring: States Can
Readily Identify Illegal Sales and Use of Controlled Substances, GAO/ HRD-
92- 115 (Washington, D. C.: July 21, 1992). 11 These percentages include two
states that subsequently terminated their PDMPs- New Mexico and West
Virginia. State PDMPs
Page 8 GAO- 02- 634 Prescription Drug Monitoring Programs Figure 1: Status
of Prescription Drug Monitoring Programs, by State, April 2002
a Pennsylvania does not have a PDMP, but requires pharmacies to submit data
to the state attorney general?s office. b West Virginia terminated its PDMP
in 1998 and has enacted legislation in 2002 to create a new program. c New
Mexico terminated its PDMP in 2000. Source: National Alliance for State
Model Drug Laws, 2002, and discussions with officials in New Mexico,
Pennsylvania, and West Virginia. CA OR
WA MT ID
ND SD
IA MO
AR TN
KY WY
NV UT AZ NM c OK
TX HI CO
KS NE
MN WI
IL MI
IN OH PA a
WV b VA
NC SC GA AL
FL MS
LA NY
VT ME
MA RI NH
DE MD CT
NJ States that do not have prescription drug monitoring programs States that
have a task force and are considering legislation to establish a program
States that have recently introduced legislation to establish a program
States that have prescription drug monitoring programs
AK
Page 9 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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. 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 National Alliance for
Model State Drug Laws
PDMPs Vary in Objectives, Design, and Operation
Program Objectives Include Education as Well as Law Enforcement
Page 10 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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.) Program
Designs Differ
Across States
Page 11 GAO- 02- 634 Prescription Drug Monitoring Programs Table 1:
Characteristics of State Prescription Drug Monitoring Programs State Year
implemented Controlled substance
schedule( s) monitored Type of monitoring system Administrative agency
California a 1940 II Electronic and triplicate form b Pharmacy and law
enforcement Hawaii 1943 II Electronic Law enforcement Idaho 1967 II, III and
IV Electronic Pharmacy board Illinois 1961 II Electronic Public health
Indiana 1995 II Electronic Law enforcement
Kentucky 1999 II, III, IV and V Electronic Public health Massachusetts 1992
II Electronic Public health Michigan c 1989 II Single form Commerce Nevada
1997 II, III, and IV Electronic Pharmacy board and law enforcement New York
d 1977 II Electronic Public health Oklahoma 1991 II Electronic Law
enforcement
Rhode Island 1979 II, III Electronic Public health Texas e 1982 II
Electronic Law enforcement Utah 1997 II, III, IV, and V Electronic
Commerce?s Licensing Division Washington f 1987 Determined by disciplinary
authority Triplicate form b Public health a California is currently testing
an electronic monitoring program for Schedule II controlled substances.
Until the pilot program is completed on July 1, 2003, pharmacies will also
have to continue submitting copies of the triplicate forms to the state
monitoring agency. b A triplicate prescription form is a paper prescription
form issued by the state to prescribers, who must use it when writing
prescriptions for covered controlled substances. The prescriber keeps one
copy after writing the prescription, and the pharmacist keeps a copy when
the prescription is filled and sends the third copy to the state PDMP. c In
2001, Michigan enacted legislation to convert its PDMP to an electronic
monitoring program. Until the new electronic system is implemented, the
program will continue to require pharmacies to submit copies of state-
issued official prescription forms for schedule II controlled substances. d
As of January 1, 2002, New York switched to an electronic monitoring system
from a paper- based
system using a triplicate form. The new electronic system is supplemented by
a state- issued, singlecopy prescription form that includes a number of
security features to prevent counterfeits. e Beginning in September 1999,
Texas permitted pharmacies to submit prescription data electronically rather
than submitting paper copies of prescription forms. In March 2002, Texas
switched from triplicate to single- copy forms with a number of security
features to prevent counterfeits. The
requirement to submit prescription forms to the state agency will continue
until the electronic system is fully implemented. f The Washington program
applies only to licensed practitioners whose prescribing practices require
monitoring because of past drug abuse or inappropriate prescribing. The
drugs the program covers vary, depending on the prescriber, from one
controlled substance to all prescriptions. Source: National Alliance for
Model State Drug Laws. Information is current through February 4, 2002.
Page 12 GAO- 02- 634 Prescription Drug Monitoring Programs 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, 12 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
12 Michigan is moving to an electronic system.
Page 13 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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.
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
drugdispensing 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 A Few
PDMPs Operate
Proactively, but Most Operate Reactively Design and Operational Factors
Affect Program
Costs
Page 14 GAO- 02- 634 Prescription Drug Monitoring Programs 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
Page 15 GAO- 02- 634 Prescription Drug Monitoring Programs by all users,
particularly physicians, and to be able to provide periodic reports about
state drug usage trends and possible diversion. 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.
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.
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
State Programs Have Helped Shorten Investigation Time
and Reduced Illegal Drug Diversion Investigation Time and
Productivity Have Improved
Programs Have Helped Reduce Availability of Abused Drugs
Page 16 GAO- 02- 634 Prescription Drug Monitoring Programs 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. 13 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, 14 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
13 OxyContin, Hearings Before the Subcommittee on the Departments of
Commerce, Justice, and State, the Judiciary, and Related Agencies, House
Committee on Appropriations, 107th Cong. Part 10, pp. 21, 22 (2001)
(Statement of Asa Hutchinson, Administrator of the Drug Enforcement
Administration). 14 New Mexico?s PDMP was terminated in June 2000.
Page 17 GAO- 02- 634 Prescription Drug Monitoring Programs PDMP states-
because of the presence of Kentucky?s PDMP, according to a joint federal,
state, and local drug diversion report. 15 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.
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. 15 Appalachia High Intensity Drug Trafficking Area
Investigative Support Center, with the assistance of the National Drug
Intelligence Center, The OxyContin Threat in Appalachia,
August 2001. Challenges Exist in
Establishing and Expanding State PDMPs
Extent of Diversion and Abuse Is Not Always Recognized
Page 18 GAO- 02- 634 Prescription Drug Monitoring Programs 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. 16 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
16 The federal Health Insurance Portability and Accountability Act of 1996
(HIPAA) generally preempts state health information privacy laws, unless
they provide a higher level of protection than the act. (Pub. L. No. 104-
191, sect.262, 110 Stat. 1936, 2029.) However, these state privacy provisions
may not be preempted if the Secretary of Health and Human Services
determines that the state law has as its principal purpose the regulation of
the manufacture, registration, distribution, dispensing, or other control of
any controlled substances (as defined in 21 U. S. C. sect.802), or that is
deemed a controlled substance by state law. (45 C. F. R. sect.160.203 (a)( 2))
Physicians, Patients, and Pharmacists Express
Concerns About Confidentiality
Page 19 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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, 17 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.
17 Nevada received a total of $265, 000 for the first 2 years of the
program?s operations, including 2- year grants from two pharmaceutical
companies and the state board of medical examiners. Securing Program Funding
Is a Critical Challenge
Page 20 GAO- 02- 634 Prescription Drug Monitoring Programs 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.
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. 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. National Efforts Have
Focused on Providing Guidance and Technical Assistance
The Alliance Provides Models and Technical Assistance for States DEA Has
Assisted States in
Dealing with Drug Diversion and Abuse
Page 21 GAO- 02- 634 Prescription Drug Monitoring Programs 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. 18 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.
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
18 Departments of Commerce, Justice, and State, the Judiciary, and Related
Agencies Appropriations Act, 2002, Pub. L. No. 107- 77 (2001). The $2
million grant is itemized as the
?Harold Rogers Prescription Drug Monitoring Program? (H. R. Conf. Rep. No.
107- 278, at 90( 2001)). Concluding Observations
Page 22 GAO- 02- 634 Prescription Drug Monitoring Programs 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. 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.
Janet Heinrich Director, Health Care- Public Health Issues Agency Comments
Appendix I: Key Features of Selected State Prescription Drug Monitoring
Programs
Page 23 GAO- 02- 634 Prescription Drug Monitoring Programs This table
summarizes the key features of the state prescription drug monitoring
programs (PDMPs) in Kentucky, Nevada, and Utah.
Table 2: Key Features of Selected State Prescription Drug Monitoring
Programs Key features Kentucky Nevada Utah
Census 2000 population 4.04 million 1.99 million 2.23 million Year
operational 1999 1997 1997
Start- up funding $415,000 in federal start- up grant funds $134,000 a in
state funds $50,000 in one time state funds
Controlled substance schedules monitored II, III, IV, V II, III, IV II, III,
IV, V Electronic data collection and reporting Yes Yes Yes Private
contractor receives
dispensing information and creates database Yes Yes No Annual operating
costs (estimate) $500,000 $112,000 $150,000
Staff 4 full- time (1 licensed pharmacist investigator, 2 pharmacy
technicians, 1 data entry operator) and 4 part- time 1 full- time with all
administrative duties 3 full- time including manager and 2 support staff
Number of pharmacies reporting dispensing data (estimate) 1,300 387 375
Number of daily data requests received (estimate) 400 20 130 to 150 Report
turnaround time to requestor (estimate) 4 hours 4 hours 3 hours
Penalty for unauthorized use or disclosure of PDMP data Class D felony b
PDMP statute has no penalty Third- degree felony c a Nevada received
$265,000 for the first 2 years of its program?s operations, including 2-
year grants from two pharmaceutical companies and the state board of medical
examiners. b Kentucky law defines a class D felony as one carrying a
sentence of at least 1 year, but not more than 5 years in prison. c Utah law
defines a third- degree felony as one carrying a sentence of not more than 5
years in prison. Source: GAO interviews with PDMP administrators. Appendix
I: Key Features of Selected State Prescription Drug Monitoring Programs
Appendix II: GAO Contact and Staff Acknowledgments Page 24 GAO- 02- 634
Prescription Drug Monitoring Programs John C. Hansen, (202) 512- 7105
In addition to the above, Robert Dee, Preety Gadhoke, Opal Winebrenner,
Roseanne Price, and George Bogart made key contributions to this report.
Appendix II: GAO Contact and Staff
Acknowledgments GAO Contact Acknowledgments (290131)
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