Prescription Drugs
State Monitoring Programs Provide Useful Tool to Reduce Diversion
Gao ID: GAO-02-634 May 17, 2002
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.
GAO-02-634, Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion
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United States General Accounting Office:
GAO:
Report to the Subcommittee on Oversight and Investigations, Committee
on Energy and Commerce, House of Representatives.
May 2002:
Prescription Drugs:
State Monitoring Programs Provide Useful Tool to Reduce Diversion:
GAO-02-634:
Contents:
Letter:
Results in Brief:
Background:
PDMPs Vary in Objectives, Design, and Operation:
State Programs Have Helped Shorten Investigation Time and Reduced
illegal Drug Diversion:
Challenges Exist in Establishing and Expanding State PDMPs:
National Efforts Have Focused on Providing Guidance and Technical
Assistance:
Concluding Observations:
Agency Comments:
Appendix I: Key Features of Selected State Prescription Drug
Monitoring Programs:
Appendix II: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Characteristics of State Prescription Drug Monitoring
Programs:
Table 2: Key Features of Selected State Prescription Drug Monitoring
Programs:
Figure:
Figure 1: Status of Prescription Drug Monitoring Programs, by State,
April 2002:
Abbreviations:
DEA: Drug Enforcement Administration:
HIPAA: Health Insurance Portability and Accountability Act of 1996:
ODC: Office of Diversion Control:
PDMP: prescription drug monitoring program:
[End of section]
United States General Accounting Office:
Washington, DC 20548:
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,[Footnote 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.[Footnote 2] 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[Footnote 3] on the features of the existing programs.[Footnote 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.
Results in Brief:
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 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 appendix 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.
Background:
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.[Footnote 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.
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[Footnote 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.[Footnote 7]
Controlled Substances Act:
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.
[Footnote 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 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 Ill
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 Regulation of the Practice of Medicine and Pharmacy:
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.[Footnote 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.
State PDMPs:
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[Footnote 10] to 15 in 2002. (See figure 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.[Footnote 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 figure 1.)
Figure 1: Status of Prescription Drug Monitoring Programs, by State,
April 2002:
[Refer to PDF for image: map of the United States]
States that have prescription drug monitoring programs:
California:
Hawaii:
Idaho:
Illinois:
Indiana:
Kentucky:
Massachusetts:
Michigan:
Nevada:
New York:
Oklahoma:
Rhode Island:
Texas:
Utah:
Washington:
States that have recently introduced legislation to establish a
program:
Connecticut:
Maine:
Ohio:
Vermont:
Virginia:
West Virginia[B]:
States that have a task force and are considering legislation to
establish a program:
Alabama:
Colorado:
New Hampshire:
States that do not have prescription drug monitoring programs:
Alaska:
Arizona:
Arkansas:
Delaware:
Florida:
Georgia:
Iowa:
Kansas:
Louisiana:
Maryland:
Minnesota:
Mississippi:
Missouri:
Montana:
Nebraska:
New Jersey:
New Mexico[C]:
North Carolina:
North Dakota:
Oregon:
Pennsylvania[A]:
South Carolina:
South Dakota:
Tennessee:
Wisconsin:
Wyoming:
[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.
[End of figure]
National Alliance for Model State Drug Laws:
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.
PDMPs Vary in Objectives, Design, and Operation:
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.
Program Objectives Include Education as Well as Law Enforcement:
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.
Program Designs Differ Across States:
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.)
Table 1: Characteristics of State Prescription Drug Monitoring
Programs:
State: California[A];
Year implemented: 1940;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic and triplicate form[B];
Administrative agency: Pharmacy and law enforcement.
State: Hawaii;
Year implemented: 1943;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Law enforcement.
State: Idaho;
Year implemented: 1967;
Controlled substance schedule(s) monitored: II, III and IV;
Type of monitoring system: Electronic;
Administrative agency: Pharmacy board.
State: Illinois;
Year implemented: 1961;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Public health.
State: Indiana;
Year implemented: 1995;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Law enforcement.
State: Kentucky;
Year implemented: 1999;
Controlled substance schedule(s) monitored: II, III, IV and V;
Type of monitoring system: Electronic;
Administrative agency: Public health.
State: Massachusetts;
Year implemented: 1992;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Public health.
State: Michigan[C];
Year implemented: 1989;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Single form;
Administrative agency: Commerce.
State: Nevada;
Year implemented: 1997;
Controlled substance schedule(s) monitored: II, III, and IV;
Type of monitoring system: Electronic;
Administrative agency: Pharmacy board and law enforcement.
State: New York[D];
Year implemented: 1977;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Public health.
State: Oklahoma;
Year implemented: 1991;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Law enforcement.
State: Rhode Island;
Year implemented: 1979;
Controlled substance schedule(s) monitored: II, III;
Type of monitoring system: Electronic;
Administrative agency: Public health.
State: Texas[E];
Year implemented: 1982;
Controlled substance schedule(s) monitored: II;
Type of monitoring system: Electronic;
Administrative agency: Law enforcement.
State: Utah;
Year implemented: 1997;
Controlled substance schedule(s) monitored: II, III, IV, and V;
Type of monitoring system: Electronic;
Administrative agency: Commerce's Licensing Division.
State: Washington[F];
Year implemented: 1987;
Controlled substance schedule(s) monitored: Determined by disciplinary
authority;
Type of monitoring system: Triplicate form[B];
Administrative agency: 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, single-
copy 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.
[End of table]
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,[Footnote 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 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.
A Few PDMPs Operate Proactively, but Most Operate Reactively:
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.
Design and Operational Factors Affect Program Costs:
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.
State Programs Have Helped Shorten Investigation Time and Reduced
Illegal Drug 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.
Investigation Time and Productivity Have Improved:
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.
Programs Have Helped Reduce Availability of Abused Drugs:
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.
[Footnote 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,[Footnote 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-PDMP states”because of the
presence of Kentucky's PDMP, according to a joint federal, state, and
local drug diversion report.[Footnote 15]
Challenges Exist in Establishing and Expanding State PDMPs:
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.
Extent of Diversion and Abuse Is Not Always Recognized:
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.
Physicians, Patients, and Pharmacists Express Concerns About
Confidentiality:
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.[Footnote
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 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.
Securing Program Funding Is a Critical Challenge:
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,
[Footnote 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.
National Efforts Have Focused on Providing Guidance and Technical
Assistance:
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 Provides Models and Technical Assistance for States:
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.
DEA Has Assisted States in Dealing with Drug Diversion and Abuse:
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.[Footnote 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.
Concluding Observations:
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.
Agency Comments:
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 [hyperlink,
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.
Signed by:
Janet Heinrich:
Director, Health Care”Public Health Issues:
[End of section]
Appendix I: Key Features of Selected State 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: Census 2000 population;
Kentucky: 4.04 million;
Nevada: 1.99 million;
Utah: 2.23 million.
Key features: Year operational;
Kentucky: 1999;
Nevada: 1997;
Utah: 1997.
Key features: Start-up funding;
Kentucky: $415,000 in federal start-up grant funds;
Nevada: $134,000[A] in state funds;
Utah: $50,000 in one time state funds.
Key features: Controlled substance schedules monitored;
Kentucky: II, III, IV, V;
Nevada: II, III, IV;
Utah: II, III, IV, V.
Key features: Electronic data collection and reporting;
Kentucky: Yes;
Nevada: Yes;
Utah: Yes.
Key features: Private contractor receives dispensing information and
creates database;
Kentucky: Yes;
Nevada: Yes;
Utah: No.
Key features: Annual operating costs (estimate);
Kentucky: $500,000;
Nevada: $112,000;
Utah: $150,000.
Key features: Staff;
Kentucky: 4 full-time (1 licensed pharmacist investigator, 2 pharmacy
technicians, 1 data entry operator) and 4 part-time;
Nevada: 1 full-time with all administrative duties;
Utah: 3 full-time including manager and 2 support staff.
Key features: Number of pharmacies reporting dispensing data
(estimate);
Kentucky: 1,300;
Nevada: 387;
Utah: 375.
Key features: Number of daily data requests received (estimate);
Kentucky: 400;
Nevada: 20;
Utah: 130 to 150.
Key features: Report turnaround time to requestor (estimate);
Kentucky: 4 hours;
Nevada: 4 hours;
Utah: 3 hours.
Key features: Penalty for unauthorized use or disclosure of PDMP data;
Kentucky: Class D felony[B];
Nevada: PDMP statute has no penalty;
Utah: 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.
[End of table]
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
John C. Hansen, (202) 512-7105:
Acknowledgments:
In addition to the above, Robert Dee, Preety Gadhoke, Opal
Winebrenner, Roseanne Price, and George Bogart made key contributions
to this report.
[End of section]
Footnotes:
[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.
[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.
[5] Drug Enforcement Administration and the National Alliance for
Model State Drug Laws, A Closer Look at State Prescription Monitoring
Programs [hyperlink,
http://www.deacliversion.usdoj.gov/pubs/program/rx-onitor/summary.htm]
accessed September 17, 2001).
[6] Title II of the Comprehensive Drug Abuse Prevention and Control
Act of 1970 (Pub. L. No. 91-513, §§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.
[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.
[10] U.S. General Accounting Office, Prescription Drug Monitoring:
States Can Readily Identify Illegal Sales and Use of Controlled
Substances, [hyperlink, http://www.gao.gov/products/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.
[12] Michigan is moving to an electronic system.
[13] 0xyContin, 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.
[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.
[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, §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. §802), or that is deemed a controlled substance by state
law. (45 C.F.R. §160.203 (a)(2))
[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.
[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)).
[End of section]
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