[Senate Hearing 108-806]
[From the U.S. Government Publishing Office]
S. Hrg. 108-806
PRESCRIPTION DRUG ABUSE AND DIVERSION: THE ROLE OF PRESCRIPTION DRUG
MONITORING PROGRAMS
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
ON
EXAMINING DRUG ABUSE PREVENTION ISSUES, FOCUSING ON THE ROLE OF
PRESCRIPTION DRUG MONITORING PROGRAMS, AND FEDERAL PRIVACY STANDARDS
FOR PMPS
__________
September 23, 2004
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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_____________________________________________________________________________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
JUDD GREGG, New Hampshire, Chairman
BILL FRIST, Tennessee EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama PATTY MURRAY, Washington
JOHN ENSIGN, Nevada JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia HILLARY RODHAM CLINTON, New York
Sharon R. Soderstrom, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
STATEMENTS
Thursday, September 23, 2004
Page
Sessions, Hon. Jeff, a U.S. Senator from the State of Alabama,
opening statement.............................................. 1
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts, prepared statement.............................. 3
Whitfield, Hon. Ed, a U.S. Congressman from the State of
Kentucky, opening statement.................................... 37
Prepared statement........................................... 39
Dodd, Hon. Christopher J., a U.S. Senator from the State of
Connecticut, prepared statement................................ 49
Holsinger, James W., Jr., M.D., Secretary, Kentucky Cabinet for
Health and Family Services; Sherry Green, Executive Director,
National Alliance for Model State Drug Laws, Alexandria, VA;
Kenneth G. Varley, M.D., President and Executive Director,
Alabama Society of Interventional Pain Physicians, and Board
Member, American Society of Interventional Pain Physicians; and
Joy L. Pritts, Assistant Research Professor, Health Policy
Institute, Georgetown University............................... 5
Prepared statements of:
Dr. Holsinger............................................ 8
Ms. Green................................................ 10
Dr. Varley............................................... 18
Ms. Pritts............................................... 34
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
David Kloth, M.D., (NASPER).................................. 51
(iii)
PRESCRIPTION DRUG ABUSE AND DIVERSION: THE ROLE OF PRESCRIPTION DRUG
MONITORING PROGRAMS
----------
THURSDAY, SEPTEMBER 23, 2004
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 2:08 p.m., in
room SD-430, Dirksen Senate Office Building, Hon. Jeff
Sessions, presiding.
Present: Senator Sessions.
Opening Statement of Senator Sessions
Senator Sessions. Good afternoon. I am Senator Jeff
Sessions, and I appreciate your attendance at a hearing today
that I think will be interesting and deals with a very
significant and important subject that may not solve all the
problems we have in the world, but it deals with a very
significant, discrete problem that is growing in America today.
I want to thank Senator Judd Gregg, chairman of our Health,
Education, Labor, and Pensions Committee, for allowing and
encouraging us to have this hearing. And we have a good panel,
and we will be discussing an important issue.
Over the past 10 years, the abuse and diversion of
prescription drugs has grown from a regional crisis to a
national epidemic. The Substance Abuse and Mental Health
Services Administration recently released the studies of the
2003 National Survey on Drug Use and Health. Newspapers across
the country reported the data that suggested that while the use
of illicit drugs, such as cocaine, remained steady or even
declined, the figure on the nonmedical use of prescription
medications had a different story.
Prescription drugs now rank second only to marijuana in the
incidence of abuse. In a 1-year period, the number of
nonmedical users of pain relievers increased to a total of 31.2
million American adolescents and adults who have abused these
medications at least one time in their lifetime. The number of
first-time abusers, those who have abused prescription drugs
for the first time, has increased 336 percent since 1990. And
make no mistake, prescription drug addiction is a powerful
addiction.
While press coverage has frequently focused on the abuse
and diversion of OxyContin and other narcotic pain relievers,
it is clear that this problem extends to several classes of
commonly prescribed drugs, including tranquilizers and
stimulants. In fact, the 2003 National Survey data reflected an
ever sharper increase in the nonmedical use of tranquilizers.
All in all, it is estimated that over 6 million Americans
are current abusers of prescription drugs that fall within
these classes. The black market in diverted prescription drugs
is now a multibillion-dollar industry. I remember as a Federal
prosecutor that drugs like Dilaudid were regularly sold on the
streets of our communities for $60 to $80 a pill, and it
results in a powerful addiction.
These numbers, tens of millions, frequently obscure the
human tragedy of drug abuse and dependence. Each of us has
heard the news stories of famous persons who have developed
prescription drug abuse problems, and for many it has hit close
to our own homes. Frequently, these stories involved a
legitimate first prescription that evolves into an addiction
and familiar pattern of drug-seeking behavior that takes
addicts from doctor to doctor to get their kicks.
To their credit, doctors do not want to be a part of this
cycle. In fact, physicians have been the leading advocates for
effective programs to combat prescription drug abuse and
diversion. I remember in around 1990 I chaired a committee in
Alabama on law enforcement issues, and we spent a lot of time
on this very issue. We were amazed how much abuse of
prescription drugs there was in the city of Mobile, and a
number of steps were taken that improved that. We even
discussed legislation that would create a system somewhat like
this for the State of Alabama.
This epidemic has driven, though, additional societal
costs. The addicted fall from the productive ranks of society
into unemployment, disability, hospitalization, and, too
frequently, crime and incarceration. Their families and
communities suffer along with them. Taxpayers bear the expense
of purchasing abused or illegally diverted drugs through public
programs and subsequently treating the medical consequences of
misuse and addiction. Law enforcement agencies, particularly in
rural areas, are stretched beyond their limits as the scourge
sweeps through depressed and disadvantaged communities
particularly.
The physician-patient relationship has suffered as well.
The growing addiction problem and the black market that feeds
it has created an atmosphere in which physicians fear that
prescribing certain high-risk medications could lead to civil
liability or professional discipline. As a result, the problem
has created yet another class of victims: patients who might
find it more difficult to obtain timely, effective treatment
for pain and other legitimate medical needs.
Clearly, the solution depends on early identification and
intervention of those who may be becoming addicted to illicit
drugs. If you can intervene early before a person has sustained
a serious addiction, that is the best time to do it.
The purpose of today's hearing is to attempt to develop
some sense of the scope and nature of this problem and then to
look beyond the tragic losses and tremendous costs to potential
solutions. So I am particularly interested in an approach that
has been adopted by a growing number of States and has shown
promising results: the prescription drug monitoring program. At
the present time, 19 States have operating prescription drug
monitoring programs. These monitoring programs have been used
by health care providers to better deliver appropriate,
effective treatment of pain and other conditions that require
the use of scheduled drugs and to identify and, if appropriate,
refer for treatment patients whose prescription history
suggests that they are at risk for addiction.
I am interested also in the extent to which such systems
could enhance the ability of law enforcement to better direct
its resources to reduce this problem and to reduce the
investigation times. Additionally, at a time when no discussion
of health care should avoid the topic of cost, Federal, State,
and private payers frequently are the ones who shoulder the
substantial burden of purchasing diverted drugs as well as
treating the medical sequelae of abuse. Finding a cost-
efficient tool to effectively reduce the incidence of diversion
and abuse could be expected to provide substantial savings,
particularly for many States' financially strapped Medicare
programs.
It appears the States that have instituted prescription
drug monitoring programs have realized substantial benefits. A
2002 GAO study of these programs concluded that prescription
monitoring programs appear to have reduced illegal drug
diversion. However, several important issues were raised,
including the fact that while States with monitoring programs
saw a reduction in drug diversion activity, their neighboring
States without programs tended to experience a corresponding
rise, and addicts and black marketeers shifted their efforts
across State borders.
I am pleased that after several years of effort and with my
full support, my own State of Alabama is moving toward
instituting a prescription drug monitoring program. Of course,
Alabama's program will likely affect our neighbors in
Mississippi and Tennessee and Georgia and Florida. Certainly
coordination among States' programs is a matter we must
discuss. In keeping with the broadly shared goal of improving
health information technology capabilities throughout the
health care system--and we need to do more of that--testimony
will also focus on current legal and technical barriers to
making a relevant patient medication history available to
appropriate parties and for appropriate purposes across State
lines.
Despite sharing many common elements, these programs do
differ, and any Federal effort to improve on or expand
prescription drug monitoring must take these differences into
account.
We will include in the record at this point the prepared
statement of Senator Kennedy.
[The prepared statement of Senator Kennedy follows:]
Prepared Statement Of Senator Edward M. Kennedy
I commend my colleague, Senator Sessions, for holding
today's hearing on the growing national concern over
prescription drug abuse. Over 6 million Americans use
prescription medications for non-medical purposes. Since 1992,
the number of young adults who abuse prescription pain
relievers and other potentially addictive drugs has more than
tripled, and prescription drug abuse among youths aged 12 to 17
has increased ten fold.
State programs to monitor the prescribing of potentially
addictive medications can help curb this abuse. Currently, 19
States have monitoring programs in place, including
Massachusetts. The information can be used to identify
physicians and patients who encourage the non-medical use of
prescription drugs and can also be used to reduce the diversion
of prescription drugs for illegal purposes.
Any such program, however, must include strong safeguards
for medical privacy, and make certain that the database cannot
be used to bring improper pressure on physicians to avoid
prescribing essential medication for patients in need. The
proper treatment of patients in pain, for example, is an
enormous medical challenge, but this essential work will be
more difficult if patients fear that the privacy of their
prescription histories will not be protected, or if physicians
begin to look over their shoulders every time they prescribe
needed pain medication.
Congressman Whitfield and Congressman Pallone have
introduced legislation to establish a national electronic
database to monitor these prescriptions, and I understand that
Senator Sessions may introduce similar legislation in the
Senate. We all share the goal of striking the right balance
between the interests of patients, physicians, and law
enforcement, and I'm confident we can work together to enact
legislation that achieves this balance.
The current House legislation, however, grants law
enforcement officials access too easily to the information in
the database. Under the House bill, if law enforcement
officials feel the information will strengthen an
investigation, they are granted access to it, without obtaining
a court order, and without requiring a review of the validity
of the requests before granting access to sensitive medical
information.
Massachusetts' State monitoring program includes important
safeguards against improper use of information in the database.
It also protects against intrusive use of the database by law
enforcement agencies, and it includes a peer review group of
health professionals to review data collected by the program
for signs of abuse or diversion. If the expert group identifies
data suggesting misuse, the Public Health Commissioner is
notified, and the Commissioner and the review group decide
whether to handle the situation internally or notify law
enforcement.
If a law enforcement authority requests data on a specific
physician or patient, the peer review group analyzes the data
requested. If the data suggests abuse or diversion, they
fulfill the request. If the evidence is inadequate, the review
group will decline to release sensitive medical information.
The peer review group is thus a protector and gatekeeper
for the data in the State monitoring program. Massachusetts has
successfully implemented its monitoring system, and has taken
steps to protect the privacy of medical records and avoid
undermining the trust between doctor and patient.
I commend Senator Sessions for bringing the attention of
the committee to this important issue, and for highlighting the
benefits of a national electronic database to monitor misuse. I
look forward to working with our colleagues on the committee to
see that the legislation protects patient privacy and prevents
data from being abused.
I commend our witnesses for their testimony today, and I
look forward to their recommendations.
Senator Sessions. We have a very distinguished group of
witnesses before the committee today. I think Congressman
Whitfield is not with us at this point, not yet, and we expect
him to join us in a little bit. But we will start with our
larger panel first.
I also see my former colleague, Tim Hutchinson. Tim, thank
you for your leadership on this issue and bringing to my
attention the importance of this issue.
This very distinguished group of witnesses before the
committee today should be able to shed some important light on
these matters. I look forward to the opportunity that this will
provide Members of Congress to develop a better understanding
of this problem and to carefully consider how to provide the
most useful and appropriate Federal response.
Our first panel will consist of four additional witnesses:
Dr. James Holsinger, the Secretary of the Kentucky Cabinet for
Health and Family Services--Jim, you can step on up, and I
believe your name tag is there--the agency in Kentucky that
administers the prescription drug monitoring program. Dr.
Holsinger can provide important details on the operation and
impact of the KASPER program. He also is a writer and author,
having written an exceptionally fine book on the Methodist
Church that is read throughout the denomination, and I can say
with certainty it has been a positive influence for the
denomination.
Dr. Kenneth Varley is the president of the Alabama Society
of Interventional Pain Physicians and is a practicing pain
specialist in Birmingham, Alabama.
Sherry Green is the executive director of the National
Alliance on Model State Drug Laws, an organization that has
provided important legal and technical guidance for States that
have elected to implement monitoring programs and other drug
laws that you help them with.
Finally, Joy Pritts is currently an assistant research
professor at Georgetown University's Health Policy Institute
and an expert who has published extensively and testified
before Congress on medical privacy matters. Thank you, Ms.
Pritts. We are going to hear from you on the privacy question.
So I look forward to hearing from you, and, Dr. Holsinger,
if you would begin, we would be glad to hear your testimony.
And our time limit will be about 5 minutes. The light will turn
red up here, I believe, and you do not sink into the ocean if
you go beyond, but, Dr. Holsinger, we are delighted to have you
with us.
STATEMENTS OF HOLSINGER, JAMES W., JR., M.D., SECRETARY,
KENTUCKY CABINET FOR HEALTH AND FAMILY SERVICES; SHERRY GREEN,
EXECUTIVE DIRECTOR, NATIONAL ALLIANCE FOR MODEL STATE DRUG
LAWS, ALEXANDRIA, VA; KENNETH G. VARLEY, M.D., PRESIDENT AND
EXECUTIVE DIRECTOR, ALABAMA SOCIETY OF INTERVENTIONAL PAIN
PHYSICIANS, AND BOARD MEMBER, AMERICAN SOCIETY OF
INTERVENTIONAL PAIN PHYSICIANS; AND JOY L. PRITTS, ASSISTANT
RESEARCH PROFESSOR, HEALTH POLICY INSTITUTE, GEORGETOWN
UNIVERSITY
Dr. Holsinger. Senator Sessions, it is a real pleasure to
be here with you today. I am here to discuss briefly Kentucky's
implementation of a prescription drug monitoring program, the
status of the current system enhancements, and the goals of the
Commonwealth of Kentucky in detecting and preventing
prescription drug abuse and diversion.
Before I begin, I would certainly like to thank and
recognize Congressman Ed Whitfield who is passionate about
wanting us to work toward reducing the abuse of prescription
drugs in the Commonwealth and beyond, and also Congressman Hal
Rogers, the Dean of Kentucky's congressional delegation, for
all of his hard work to reduce the abuse of prescription drugs.
Senator Sessions. Dr. Holsinger, I would say that I
understand the House is in a series of votes. Congressman
Whitfield came by and talked to me yesterday. I am sure he will
be here when he can break free.
Dr. Holsinger. There is no question that prescription drug
abuse and diversion is a public health crisis of significant
magnitude. Accordingly, failing to combat this issue with great
vigor on multiple fronts and in a highly coordinated fashion
will undoubtedly lead to dire health and safety consequences
nationwide.
Prescription drug monitoring programs are designed to help
prevent and detect the diversion and abuse of pharmaceutical
controlled substances, particularly at the retail level. States
that have implemented prescription monitoring programs have the
capability to collect and analyze prescription data much more
efficiently than States without such programs, where the
collection of prescription information requires the manual
review of pharmacy files, a time-consuming and invasive
process.
The purpose of PMPs is to enhance the ability of health
care professionals, as well as regulatory and law enforcement
agencies, to collect and analyze controlled substance
prescription data. This is accomplished by building a data
collection and analysis system at the State level, enhancing
programs' ability to analyze and use collected data, and
facilitating the exchange of collected prescription data among
States. The increased efficiency of prescription monitoring
programs allows for the early detection of abuse trends and
possible sources of diversion. In your packet is a chart that
depicts the KASPER process, as well as some rather impressive
statistical information generated from the program.
I think one of the most impressive things that we deal with
is the fact that of the individuals and organizations that
enter the system, 85 percent of those are physicians,
indicating a high degree of acceptance on their part.
Kentucky's prescription drug monitoring program was
established during the Kentucky General Assembly's 1998
legislative session, and the program become operational in
1999.
It is commonly referred to as ``KASPER,'' which is the
acronym for the Kentucky All Schedule Prescription Electronic
Reporting system. This system automated the processing of data
to support the tracking and sharing of information in
accordance with existing statutes governing controlled
substance prescriptions.
KASPER was created with two main goals in mind: first, to
be a source of information for physicians and pharmacists; and,
second, to be an investigative tool for law enforcement. KASPER
is the instrument that enables this information to be
collected, analyzed, and shared rapidly.
Data gets into the relational database as dispensers
transmit prescription data to our data collection agent by
modem, diskette, or tape. The data collection agent then
verifies, compiles and sends the data to the Drug Enforcement
and Professional Practices Branch to be loaded into the KASPER
server.
Very high security procedures protect access to the data
with only branch personnel having access to information within
the KASPER database. Reports requested by authorized
individuals also undergo a high level of scrutiny. Release of
data to anyone not authorized by Kentucky's statute is a Class
D felony.
Currently, there are approximately 30 States with some form
of a PMP in operation although only Kentucky, Michigan, and
Nevada have electronic systems requiring the collection of data
on all scheduled drugs. In Kentucky, the KASPER program is
administered by the Cabinet for Health and Family Services'
Office of Inspector General. Controlled substance prescription
reports, KASPER reports, are available to physicians, in the
treatment of patients; pharmacists, in the treatment of
patients; law enforcement, in conjunction with a bona fide
investigation; professional licensure boards, in investigation
of their members; Medicaid departments, for prevention of fraud
and abuse; and by grand jury subpoena and court orders.
Many of the clinicians in the State were skeptical when
KASPER was initiated. They felt the scrutiny implied by a
monitoring program would interfere with their practice. In
actuality, they have found that by utilizing the program to
monitor their patients chronically utilizing controlled
substances, they have documentation to prove they are treating
these patients judiciously. Indeed, as a result of KASPER,
reporting of KASPER productivity in a variety of instances,
including that of law enforcement, has increased 30-fold and
investigative productivity has improved 5-fold.
In 2003, the Kentucky Legislature appropriated $1.4 million
to enhance the current KASPER system. The goals of the Enhanced
KASPER, eKASPER system, are to automate the labor-intensive
processes of report creation, reduce report distribution from a
4-hour goal to 15 minutes, and assure HIPAA compliance at all
levels.
In 2004, the Kentucky General Assembly passed legislation
that empowers the Cabinet to develop structures and processes
with the KASPER system to study utilization trends, make
referrals to law enforcement and regulatory bodies, and utilize
KASPER reports in administrative hearings. It is our absolute
intention to continue to refine and enhance our efforts in
detecting and preventing prescription drug abuse and diversion
in the Commonwealth. As I have discussed today, KASPER is a
vital tool that plays a critical role in our efforts. KASPER is
as useful for the physician as it is for the investigator. Of
course, as it is the surgeon, not the scalpel, that saves the
patient, ultimately these issues will only be solved by
employing the skill and knowledge of individuals from a variety
of fields. It is our belief that only a balanced and systemic
approach that includes prevention, education, treatment, and
enforcement will have a significant and sustainable positive
impact on what has become a very serious and insidious matter
of public health and safety.
I appreciate your time and your interest in what I believe
is a critical matter for the Commonwealth of Kentucky, as well
as nationwide. Part of what we have been involved with recently
has been a broad-scale, statewide drug control assessment
summit that occurred this year under the auspices of our new
Governor, Governor Ernie Fletcher, and our Lieutenant Governor,
Steve Pence. Out of these, we are again working to develop
statewide approaches to deal with a significant issue that
particularly has great ramifications, I believe, for us from
the point of view of not only public health but public policy.
I will be happy to answer any questions when the times
comes, Senator. Thank you very much.
Senator Sessions. Thank you very much, Dr. Holsinger.
[The prepared statement of Dr. Holsinger follows:]
Prepared Statement Of James W. Holsinger, Jr., M.D.
Chairman Judd Gregg, and esteemed Members of the Senate Committee,
I am here today to briefly discuss Kentucky's implementation of a
Prescription Drug Monitoring Program (PMP), the status of the current
system enhancements, and the goals of the Commonwealth in detecting and
preventing prescription drug abuse and diversion.
Before I begin, I would like to thank and recognize Congressman Ed
Whitfield who is passionate about wanting to work towards reducing the
abuse of prescription drugs in the Commonwealth and beyond, and
Congressman Hal Rogers, the Dean of Kentucky's Congressional
delegation, for all of his hard work to reduce the abuse of
prescription drugs.
There is no question, that prescription drug abuse and diversion is
a public health crisis of great magnitude. Accordingly, failing to
combat this issue with great vigor on multiple fronts, and in a highly
coordinated fashion will undoubtedly lead to dire health and safety
consequences nationwide.
Prescription Drug Monitoring Programs are designed to help prevent
and detect the diversion and abuse of pharmaceutical controlled
substances, particularly at the retail level. States that have
implemented prescription monitoring programs have the capability to
collect and analyze prescription data much more efficiently than States
without such programs, where the collection of prescription information
requires the manual review of pharmacy files, a time-consuming and
invasive process.
The purpose of PMPs is to enhance the ability of health care
professionals, as well as regulatory and law enforcement agencies, to
collect and analyze controlled substance prescription data. This is
accomplished by building a data collection and analysis system at the
State level, enhancing existing programs' ability to analyze and use
collected data, and facilitating the exchange of collected prescription
data among States. The increased efficiency of prescription monitoring
programs allows for the early detection of abuse trends and possible
sources of diversion.
In your packet is a chart depicting the KASPER process, as well as
some rather impressive statistical information generated from the
program.
Kentucky's prescription drug monitoring program was established
during the Kentucky General Assembly's 1998 Legislative Session, the
provisions codified under KRS 218A.202. The program did not become
operational until 1999.
The program is commonly referred to as KASPER which is the acronym
for the Kentucky All Schedule Prescription Electronic Reporting
program. This system automated the processing of data to support the
tracking and sharing of information in accordance with existing
statutes governing controlled substance prescriptions.
KASPER was created with two main goals in mind. First, to be a
source of information for physicians and pharmacists; and second, to be
an investigative tool for law enforcement. KASPER is the instrument
that enables this information to be collected, analyzed, and shared
rapidly.
Data gets into the relational database as dispensers transmit
prescription data to our data collection agent by modem, diskette or
tape. The data collection agent then verifies, compiles and sends the
data to the Drug Enforcement and Professional Practices Branch, to be
loaded into the KASPER server.
Very high security procedures protect access to the data with only
Branch personnel having access to information within the KASPER
database. Report requesting by authorized individuals also undergoes a
high level of scrutiny. Release of data to anyone not authorized by
Kentucky statute is a class D felony.
Currently, there are approximately thirty (30) States with some
form of a PMP in operation although only Kentucky, Michigan and Nevada
have electronic systems requiring the collection of data on all
scheduled drugs. In Kentucky, the KASPER program is administered by the
Cabinet for Health and Family Services' Office of Inspector General,
Division of Fraud, Waste and Abuse/Identification and Prevention, Drug
Enforcement and Professional Practices Branch. Controlled substance
prescription reports (KASPER Reports) are available to Physicians--in
the treatment of patients; Pharmacists--in the treatment of patients;
Law Enforcement--in conjunction with a bona-fide investigation;
Professional Licensure Boards--in investigation of their members;
Medicaid Departments--for prevention of fraud and abuse; and by Grand
Jury Subpoenas and Court Orders.
Many of the clinicians in the State were skeptical when KASPER was
initiated. They felt the scrutiny implied by a monitoring program would
interfere with their practice. In actuality, they have found that by
utilizing the program to monitor their patients chronically utilizing
controlled substances, they have documentation to prove they are
treating these patients judiciously. Indeed, as a result of KASPER,
reporting productivity has increased 30 fold and investigative
productivity has improved 5 fold.
In 2003, the Kentucky State Legislature appropriated $1.4M to
enhance the current KASPER system. The goals of the Enhanced KASPER
(eKASPER) system are to automate the labor-intensive processes of
report creation, reduce report distribution from a 4-hour goal to 15
minutes, and assure HIPAA compliance at all levels.
In 2004, the Kentucky General Assembly passed legislation that
empowers the Cabinet to develop structures and processes with the
KASPER system to study utilization trends, make referrals to law
enforcement and regulatory bodies, and utilize KASPER reports in
administrative hearings. It is our absolute intention to continue to
refine and enhance our efforts in detecting and preventing prescription
drug abuse and diversion in the Commonwealth. As I have discussed
today, KASPER is a vital tool that plays a critical role in our
efforts. KASPER is as useful for the physician as it is for the
investigator. Of course, as it is the surgeon, not the scalpel that
saves the patient, ultimately these issues will only be solved by
employing the skill and knowledge of individuals from a variety of
fields. It is our belief that only a balanced and systemic approach
that includes prevention, education, treatment, and enforcement will
have a significant and sustainable positive impact on what has become a
very serious and insidious matter of public health and safety.
Thank you for your time and interest in what I believe to be a very
critical matter for the Commonwealth of Kentucky, as well as
nationwide. I will be happy to answer any questions you may have.
Senator Sessions. Ms. Green?
Ms. Green. Thank you, Senator Sessions. I want to thank you
and Members of the Committee for holding this hearing and
allowing me to testify.
Since 1939, States have used prescription drug monitoring
programs, or PMPs, as they are often called, to address
prescription drug diversion and addiction. In addition to the
19 States currently operating in that they can respond to
requests for information, 24 States are actively pursuing the
establishment of a PMP; 15 of those States have Federal funds
to do so.
Information collected through the system is already
available to State regulatory and enforcement personnel under
State law. Without the PMP, they collect information manually,
going from pharmacy to pharmacy in order to gather all the
necessary information for an investigation.
States often uses these particular prescription monitoring
programs, or PMPs, as early identification mechanisms. They use
them to spot as early as possible a potential problem of
diversion or addiction and then to timely refer information to
the appropriate medical professionals or State officials who
can most appropriately address that particular problem.
Information is most often used to corroborate an existing
investigation, to assist with the legitimate prescribing of
controlled substances, to intervene as early as possible with
patients who might be addicted, to actually confirm whether or
not a particular claim against a prescriber/dispenser has a
legitimate basis, and also as an indicator to initiate the
manual investigation of a particular crime or doctor-shopping
instance.
The States are actually actively seeking these particular
programs primarily because right now those States with programs
are seeing significant decreases in investigation of time. I
know Kentucky, in addition to Nevada and Utah, are already
indicating that they have as much as 80-percent decrease in
investigation time needed to address the particular
prescription diversion and addiction problem. They are also
looking at possible instances of decrease in fraud, both in
insurance and Medicare and other health care systems, and they
are also starting to look at increased instances of referral to
addiction treatment systems.
As it stands right now, there is a national evaluation
design that is being drafted and will be finalized by the end
of the year, with the idea of hopefully over the next year
being able to scientifically document effectiveness of the
programs, particularly improvements in the programs that might
be needed, and also cost/benefits from the particular programs
that are currently in use.
As it stands right now, one of the primary areas of focus
for States with these programs and who are developing these
programs is the particular impact of interstate issues, doctor-
shopping in particular, in several States that are looking at
developing the programs. That kind of interstate issue is
impacting the dispensing and prescribing to these substances,
and States are now trying to focus on how the particular
prescription monitoring programs can be designed to address
those interstate issues.
Senator, I want to thank you again for this opportunity to
testify, and at the appropriate time I also am more than happy
to answer any questions.
Senator Sessions. Thank you. Well said.
[The prepared statement of Ms. Green follows:]
Prepared Statement Of Sherry Green
Chairman Gregg, Senator Sessions, Members of the Committee, and
staff, thank you for this opportunity to appear before you today to
offer an overview of State prescription drug monitoring programs
(PMPs). I am honored to be here to discuss this issue at a time when
Federal support for these programs and States' efforts to establish and
enhance them has never been stronger.
Definition and Intent of Prescription Drug Monitoring Programs (PMP)
For those unfamiliar with prescription monitoring programs, I offer
the following definition. A prescription monitoring program (PMP) is a
system into which prescription data for designated schedules of
controlled substances are reported dispensers to a central location
(e.g., a State agency) where the information is entered into an
electronic database. A PMP can perform three primary functions: (1)
data collection, (2) respond to requests for reports by those
authorized by statute/regulation/rule to make such requests, and (3)
optimally, data would be analyzed to spot trends and identify diversion
and addiction issues early with reports going proactively to those who
could respond (e.g., physicians, pharmacists, occupational licensing,
certification and regulatory personnel, law enforcement).
State PMPs can optimally accomplish a variety of goals related to
safeguarding public health and safety. These purposes could include: to
support the legitimate medical use of controlled substances; to
facilitate and encourage the identification, intervention with and
treatment of individuals addicted to prescription drugs; to identify
and prevent drug diversion; to provide assistance to those
investigating cases of diversion or other misuse; and to inform the
public, including health care professionals and policy makers, of use
and abuse trends related to prescription drugs (for more information
regarding the possible missions of State prescription monitoring
programs, please see Prescription Monitoring Work Group of the National
Alliance for Model State Drug Laws: Recommendations for State
Prescription Monitoring Programs, submitted with this testimony).
The data collected in the monitoring system is not ``new''
information--in other words, information that was previously
unavailable to those investigating diversion cases. With or without a
PMP in place, prescription information is accessible to regulatory and/
or law enforcement personnel with open cases involving suspected
diversion of prescription drugs. What the PMP does by serving as a
central point of collecting this data and responding to authorized
requests is to save the already limited resources of State regulatory
boards and law enforcement by eliminating the need for their staff to
go to individual pharmacies throughout the State in order to view the
specific prescription data needed for diversion investigations.
NAMSDL's History Assisting States re: PMPs
As a Congressionally-funded 501(c)(3) nonprofit organization, the
National Alliance for Model State Drug Laws (NAMSDL) has worked with
States to address alcohol and other drug problems through laws,
policies, and programs, using the model laws created by NAMSDL's
predecessor--the President's Commission on Model State Drug Laws--as a
menu of options. Prescription drug misuse, abuse, diversion, and
addiction have been among the issues on which States have sought
NAMSDL's assistance since our inception in 1993, including information
and guidance in planning, establishing, and enhancing State PMPs.
NAMSDL's Congressional funding through the Transportation, Treasury,
and General government (formerly Treasury, Postal, and General
government) appropriations has permitted us to work with States on
these issues, as well as over 70 other alcohol and other drug-related
problems. Through a grant from the Bureau Justice Assistance (BJA),
Office of Justice Programs, awarded in fiscal year 2003 (supplemented
in fiscal year 2004), NAMSDL has been able to intensify efforts to
assist States' efforts to establish PMPs and to provide opportunities
and instruments for planning for the interstate sharing of PMP data.
Additionally, NAMSDL is now able to make outreach to States which have
not historically pursued the possibility of a PMP as a tool for
addressing the misuse of, abuse of, diversion of, and addiction to
prescription drugs and for safeguarding the availability of these
controlled substances to individuals with bona fide medical needs.
PMPs in the States
States Currently Operating Programs
As I testify before you today, 19 States are currently operating
PMPs (i.e., these States have a monitoring system in place that is both
collecting reports of the designated prescription data and responding
to requests for information from those authorized to do so). These
States are: California, Hawaii, Idaho, Illinois, Indiana, Kentucky,
Maine, Massachusetts, Michigan, Nevada, New York, Oklahoma,
Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington, and West
Virginia.
A variety of State agencies house and operate these programs in the
States, based on the resources, capabilities, purview, and other State-
specific considerations as to where the PMP would be best suited in
each State (for more discussion of factors States consider in
determining which agency should house and operate a PMP, please see the
report of NAMSDL's national working group on State PMPs, submitted with
this testimony). Of the 19 State PMPs currently in place, nine are
housed and operated by State agencies responsible for public health,
five by law enforcement/public safety departments, four by Boards of
Pharmacy, and one--Maine--by the single State authority for substance
abuse (a listing of the 19 current State PMPs and their overseeing
agencies is provided with this testimony).
Projected Growth of State PMPs
In an effort to better address prescription drug misuse, abuse,
diversion, and addiction, a significant number of States are mobilizing
to establish PMPs. Wyoming and New Mexico are currently on track to
being operating State PMPs by the end of calendar year 2004. With
legislation in place, Alabama and Tennessee could be operating PMPs by
early 2005. Iowa and Mississippi have determined that they can, per
their Controlled Substances Act, establish PMPs through rule changes by
their Boards of Pharmacy; these changes are currently being pursued to
ready these States to being operating monitoring systems. Additionally,
the following 18 States are actively pursuing legislation/regulations/
rules and/or planning the structure necessary to begin these programs:
Colorado, Connecticut, Florida, Georgia, Kansas, Louisiana, New Jersey,
Ohio, Oregon, Missouri, Montana, New Hampshire, North Carolina, North
Dakota, South Carolina, South Dakota, Vermont, and Wisconsin. NAMSDL
continues to reach out with information and offers of technical
assistance to the States that have not taken steps toward establishing
PMPs or that are in the very nascent stages of planning.
Funding for State PMPs
Prior to fiscal year 2002, there were 15 States operating PMPs.
States funded these programs as part of State agency budgets, fees from
regulatory and/or licensing boards, private funding, or some
combination of these funding streams. In fiscal year 2002, the Harold
Rogers Prescription Drug Monitoring Program, a competitive grant
program administered since fiscal year 2002 by the Bureau of Justice
Assistance, Office of Justice Programs, was established to support
State efforts to plan for, establish, and enhance PMPs. Since its
inception, this funding opportunity has resulted in 14 States receiving
new program grants and 6 States netting planning grants (a listing of
States receiving these grants is provided with this testimony). To
date, eight States have asked NAMSDL staff about the possibility and
timing of fiscal year 2005 Federal funding to assist in moving their
efforts to establish programs forward. As we continue our outreach to
States to engage them in planning efforts, this interest in Federal
assistance is likely to rise.
Understanding that current Federal assistance is not intended to be
used as operating or sustaining funding, States with planning and new
program grants as well as those intending to apply for any fiscal year
2005 opportunities continue to develop options for funding the
operations of State PMPs overtime. Private funding, pharmacy licensing
fees, State appropriations, and State controlled substances
registration fees are alternatives being considered by States for the
continuing operation of new programs. Individuals working closely with
existing PMPs and efforts to establish new monitoring systems are
confident that evaluation of these programs will show cost benefits
such as reducing Medicaid and healthcare fraud, diversion investigation
time, and consequences related to untreated addiction to prescription
drugs; these savings could result in an offset of funds being available
to operate State PMPs and the continuation of these anticipated
savings.
Components of a Strong Prescription Monitoring Program
I want to share NAMSDL's observations of what appear to be key
components of PMPs and their related enabling legislation and/or
regulations/rules. While further formal evaluation of existing State
PMPs across the Nation is needed, I hope that our anecdotal findings
will be helpful in understanding the types of considerations that
States may undertake in setting up these programs.
Schedules of Drugs Monitored
Drugs monitored optimally would include Federal controlled
substances, additional specified controlled substances regulated by the
State, and drugs of concern documented to demonstrate a potential for
abuse, particularly those identified by law enforcement and addiction
treatment professionals. While not officially scheduled, some
substances can still be highly abused and require immediate attention.
In a State which requires a legislative action to schedule substances,
the prescription drug monitoring official will need the authority
through the monitoring system to immediately address the problem. If
the monitoring program only tracks controlled substances, the officials
will have to wait perhaps 6 months or more for the legislature to pass
a bill placing the abused substance on a controlled substances
schedule.
Proactive Provision of Information
The monitoring system should proactively provide information to law
enforcement, occupational licensing and other appropriate individuals.
The prescription drug monitoring official should review the information
in the system and if there is reasonable cause to believe there has
been a violation of law or a breach of occupational standards, the
official should notify the appropriate agency.
Additionally, the statute should allow the program to provide
information for public research, policy and education purposes to the
extent all information reasonably likely to reveal the patient or other
person who is the subject of the information has been removed.
Individuals Allowed to Request Information from State PMPs
Dispensers and prescribers, law enforcement officials and
occupational licensing officials should be included among the
individuals or officials allowed to request specific information from
the program.
Training for Individuals Utilizing State PMPs
Requestors of program information must demonstrate that they have
the training necessary to responsibly and properly use the information
they receive from the program. All requestors should be required to
prove that they have received training on the purpose and operation of
the program, and how to properly use the program. Additionally, health
professionals should be required to receive training on proper
prescribing practices, pharmacology and identification, treatment and
referral of patients addicted to or abusing substances monitored by the
program. This training can help physicians better assess whether the
marketing and sales information they are given about a prescription
drug's effects appears to be accurate.
Evaluation of State PMPs
An evaluation component is necessary to identify cost benefits of
the program and any recommended improvements. As part of the ongoing
assessment process, an advisory board or council should provide advice
and input regarding the development and operation of the prescription
drug monitoring system. The board or council should address issues such
as (1) what drugs of concern to be monitored, (2) what specific State
controlled substances to be monitored, (3) what constitutes diversion
and proper prescribing, (4) the content and implementation of
educational courses, (5) the interpretation of prescription monitoring
information.
Confidentiality Provisions for PMP Data
Confidentiality protections from improper use of the system or of
information from the system are important statutory provisions.
Prescription monitoring information should not be subject to public or
open records laws. Additionally, the law creating the prescription drug
monitoring program should include penalties for knowingly disclosing or
using information other than as authorized by the law.
Addressing Interstate Issues
Interstate misuse and abuse of prescription drugs is an issue each
State with a prescription drug monitoring program should attempt to
address. By statute, regulation or interstate agreement, the State
should speak to the following circumstances:
pharmacies or other dispensers located in the State with a
prescription drug monitoring program which dispense or deliver to an
address of an ultimate user in another State;
pharmacies or other dispensers located in another State
which dispense or deliver to an address of an ultimate user in the
State with a prescription drug monitoring program;
pharmacies or other dispensers located in another State
which dispense or deliver to an ultimate user with an official address
in the State with a prescription drug monitoring program.
Progress on Interstate Issues
An acknowledged challenge for States is addressing the diversion
that can occur from State to State. In enhancing existing PMPs and in
establishing new programs, States are working to include provisions for
information sharing among States with monitoring systems in order to
reduce interstate diversion. Here are several examples of current
efforts:
Provisions for Mail Order Pharmacies
In a survey conducted by NAMSDL of existing State PMPs, 12 of the
19 existing PMPs indicated that they require out-of-State mail order
pharmacies delivering or dispensing drugs into their States to report
data to their States' PMPs (HI, ID, IL, IN, KY, ME, MI, NY, OK, RI, UT,
WV). The reporting requirement is based on the license or registration
which the mail order pharmacies must obtain to conduct business or
dispense in their States. These measures can help reduce the incidents
of ``doctor shopping'' across State lines in an effort to avoid
detection by the monitoring system. A summary of NAMSDL's survey re:
how State PMPs are addressing mail order pharmacies is submitted with
this testimony.
Western States Network
Initiated by Nevada, the Western States Network is a plan to share
PMP data among the States with PMPs in the Western U.S. (currently
Nevada, Idaho, California, Oklahoma, and Texas) and Hawaii through a
secure e-mail exchange. Nevada is currently ``beta'' testing the online
technology required before working with the other States in the region
to establish legal agreements and then technology structures to begin
the proposed data exchange.
Common Data Elements To Be Collected by State PMPs
To facilitate interstate sharing of PMP data, common data elements
must be collected by each State with a monitoring system. This will
allow for consistency in reporting as well as, from a technological
standpoint, a cleaner transfer of data. The National Association of
State Controlled Substances Authorities (NASCSA) and the Alliance of
States with Prescription Monitoring Programs, based in part on a 2003
NASCSA survey of data that was being collected by State PMPs, convened
a Prescription Monitoring Standards Working Group that recommended that
States with and developing prescription monitoring systems include the
following set of data elements:
Dispenser identification number
Date prescription filled
Prescription number
Whether the prescription is new or a refill
NDC code for Controlled Substance dispensed
Quantity of Controlled Substance dispensed
Number of days' supply of Controlled Substance
Patient identification number
Patient last name
Patient first name
Patient street address
Patient city
Patient State
Patient postal code
Patient date of birth
Prescription identification number
Date of prescription issued by practitioner
Person who receives the prescription from the dispenser,
if other than the patient
Source of payment for prescription
State issued serial number, if applicable.
NAMSDL has widely distributed these recommendations to States
working to establish monitoring systems in an effort to encourage
consistency among programs that will better facilitate interstate
sharing. Additionally, NAMSDL includes members from NASCSA and Alliance
of States members in our regional planning, topical working groups, and
national meetings to keep all involved informed re: efforts in this
area.
Legal Agreements Among States
In addition to establish accommodating technology structures among
States, legal agreements must be in place to allow the exchange of PMP
data across State lines and among the entities housing the PMP and the
entities requesting the information. Legal counsel working with NAMSDL
on these issues suggests that these arrangements may resemble
interstate commerce compacts that States currently utilize. NAMSDL has
convened a national working group comprised of State administrators of
PMPs, representatives from State attorneys general's offices, public
health officials, addiction treatment professionals, law enforcement
officials, and physicians (including a pain management specialist) to
offer their expertise and recommendations toward our drafting a model
interstate compact. This model will offer a guide for States to use in
establishing these legal agreements for sharing PMP data.
Internet Pharmacies
To date, three States (Arkansas, Nevada, and Florida) have State
statutes in place addressing Internet pharmacies. Only one of these
States--Nevada--currently has a PMP; NV's Internet pharmacy law
requires Internet pharmacies to report to the State's PMP for
controlled substances delivered into the State.
Most State PMP administrators agree that as important as it is to
have legitimate Internet pharmacies report into State PMPs, the legal
sites are not the primary issue. Illegal Internet sites that acquire
and deliver controlled substances to individuals without prescriptions
for these prescription drugs are of greater concern. Federal assistance
on this issue, such as that proposed by Senator Gregg, will be
appreciated by States to alleviate the misuse, abuse, diversion, and
addiction to which these illegal sites contribute.
Technical Assistance Provided to States by NAMSDL re: PMPs
NAMSDL provides a variety of technical assistance to States as they
plan for, establish, operate, and enhance prescription monitoring
programs. In broad terms, the overarching goals of our services to
States are (1) to engage States in efforts to establish PMPs, (2) to
provide information, tools (e.g., model law, samples of grant
applications, etc.), and referrals to minimize the State resources
needed to begin efforts to implement monitoring systems, and (3) to
maximize the Federal and State resources going toward State efforts by
coordinating information and State-to-State assistance to eliminate
inadvertent ``reinvention of the wheel'' as States implement, operate,
or enhance these programs. Specific services include:
Assistance in drafting enabling legislation.
Facilitating regional planning session to further
interstate planning.
Providing information on current PMPs efforts to States
planning to establish programs.
Contacting States which have not yet mobilized to create
PMPs and providing them start-up information.
Bill status updates on States' legislative efforts.
Serving as a central point for articles, materials, and
updates re: State PMPs.
Bimonthly updates re: State efforts, materials available,
related Congressional news, and other relevant information.
Connecting key constituencies groups within and among the
States to work on establishing PMPs.
Holding an annual conference on PMPs.
Convening topical working groups to develop model acts,
reports, or other resources as needed by States to address issues
related to PMPs.
While our current grant from BJA has allowed us to intensify our
technical assistance to States, NAMSDL has worked with States re: PMPs
and the related issues since our inception. If prescription drug
diversion, misuse, abuse, and addiction continue to be priority areas
for States, NAMSDL--as it has historically--will continue to include
these issues in our work with States beyond the life of any grant or
grant program.
Opportunities for Congressional, Federal Support
I want to conclude by briefly outlining some possible opportunities
for Congress and/or the Federal Government to support States in their
efforts to create, sustain, and enhance prescription monitoring
programs. These suggestions come from feedback that NAMSDL has received
from our State colleagues as we work with them on these programs.
Funding
Given the record budget deficits in many States at this time, it is
unlikely that States will be able to establish new monitoring systems
without the assistance of outside funding. Over the past few years,
several State legislatures have actually passed the enabling
legislation for State PMPs with fiscal notes attached, indicating that
they recognized the need for and usefulness of these programs but
cannot fund them through State budgets. The timing of the fiscal year
2004 grant solicitation and State prefiling deadlines coincided,
allowing a significant increase in the number of eligible States to
apply and receive awards. Congressional support for similar grant
opportunities will continue to facilitate the growth of these programs.
Internet Pharmacies
As I have previously mentioned in this testimony, States are
concerned about the diversion of prescription drugs via illegal
Internet sites. Federal assistance--specifically Federal-State
partnerships--will be needed to effectively address this concern.
Federal Entities not Reporting to State PMPs
In NAMSDL's work with States, they have alerted us to the
dispensers of prescription drugs that are under Federal jurisdiction
and thus not required to report to State PMPs: Veterans' Administration
hospitals and medical facilities, facilities on military bases, and
tribal Nations. While these entities are housed in States, they are not
required to report designated prescription data to State PMPs. States
have indicated that it would be helpful toward further curbing
diversion and intervening early with people who may need appropriate
addiction treatment to have dispensers from these entities to report
data to these programs.
Evaluation
Earlier in my remarks, I mentioned that there has not yet been a
formal, science-based national evaluation of State PMPs. My
understanding is that an evaluation design is being developed in
conjunction with the BJA grant program. As more States consider
establishing programs and the existing 19 States plan for sustaining
their current monitoring systems, objective, concrete results from this
national evaluation re: the effectiveness of PMPs will greatly help
States justify the expenditure for these programs. Currently, States
must focus on the need for reducing prescription diversion and
addiction as well as anecdotal findings/experiences from other States'
monitoring systems when working with decision makers to establish or
sustain State PMPs. With Federal resources also facilitating the start-
up and enhancement of PMPs, this national evaluation will be
instructive as to the best uses of these funds in the future (e.g.,
continued enhancements? technology project related to the PMPs? support
to corollary systems such as addiction treatment?).
Thank you once again for the opportunity to share this information
with you. I would be happy to answer any questions that you have as the
hearing proceeds.
Senator Sessions. Dr. Varley, we are glad to have you here
from Birmingham.
Dr. Varley. Thank you. I would like to thank you, Senator
Sessions, and all of the Committee Members and staff for this
opportunity to testify regarding prescription drug monitoring
programs. I would also like to extend a special note of
gratitude to you personally and your staff for your assistance
in this matter.
I will sit here today in three capacities, the first as a
representative and board member of the American Society of
Interventional Pain Physicians. Our national organization
represents nearly 50 percent of the 6,500 interventional pain
physicians in America. Interventional pain management is that
discipline of medicine devoted to the diagnosis and treatment
of acute, sub-acute, and chronic pain and related disorders
using interventional techniques in conjunction with other
treatment modalities, including narcotic and psychotherapeutic
medications. I would like to thank our national president, Dr.
Lax Manchikanti, and our executive vice president, Dr. David
Kloth, for their assistance in preparing this presentation.
The second capacity is as an interventional pain physician
licensed to practice in the State of Alabama.
The third, and most important, as the father of three
teenage girls, one of whom, Elizabeth, is present today to
observe these proceedings.
My thoughts and prayers----
Senator Sessions. Maybe you would recognize her for us.
Elizabeth? OK. I see her. We are glad you are here.
Dr. Varley [continuing]. My thoughts and prayers are with
those in Alabama and the Gulf Coast who are recovering from the
devastation of Hurricane Ivan. The cost and destruction of
Ivan, however, pales in comparison to the effect of
prescription drug abuse and diversion in our society. I have
provided supporting data and an extensive review in my formal
presentation.
Today, chronic pain requiring treatment affects 10 to 30
percent of the population. Pain is second only to the common
cold as the most frequent presenting complaint to a physician.
Narcotic anagelsics and psychotherapeutic medications made
available through our pharmaceutical industry have brought the
treatment of pain within our grasp. Congress in its wisdom saw
fit in 1970 to pass the Controlled Substances Act to control
the manufacture and distribution of pharmaceutical substances.
Unfortunately, despite this legislation, the diversion of
legitimately prescribed medications has become such a problem
that John Walters, Director of the White House Office of
National Drug Control, states that, ``The nonmedicinal use of
prescription drugs has become an increasingly widespread and
serious problem in this country, one that calls for immediate
action.''
While most Americans recognize the risk of addiction and
even death from illicit drugs, they are less likely to
recognize the risks of prescription drugs. With increasing
frequency, Americans have sought to divert prescription drugs
for nonmedicinal purposes through theft, fraud, and forgery.
With only 4.6 percent of the world's population, the United
States consumes 80 percent of the world's opioid production.
The problem of prescription drug diversion has eclipsed illicit
drug use in public health and law enforcement challenge.
Eleven million persons abused psychotherapeutic or
analgesic medications in 2003, second only to marijuana as the
leading category of illicit drugs. The exponential rise of the
diversion of controlled substances is best exemplified by the
nonmedicinal use of OxyContin, a time-release pain killer
similar to morphine. In 1997, 221,000 persons abused this drug,
but by 2003 this number had grown to 2.8 million. Abuse of
these drugs in the chronic pain population is estimated to be
between 18 and 24 percent. The diversion of prescription
medications cuts across all parts of society without regard for
race, religious, gender, age, or national origin. Several years
ago, I performed a routine urine drug screen on a 67-year-old
male suffering from postsurgical back pain. I was prescribing
OxyContin, 40 milligrams 3 times a day, but only methadone
could be found in his urine. He was selling his OxyContin,
which was paid for by his insurance company, and buying
methadone, which is much cheaper, to control his pain. The
profit amounted to a $3,000-per-month supplement to his
retirement income.
Although most of the 30 million chronic pain patients are
honest, from 3 to 8 million persons a year are trying to
deceive physicians and divert prescription drugs.
Unfortunately, the availability of diverted prescriptions is no
more apparent than in our schools. Evidence shows that drugs
are available as early as middle school and there is widespread
sale and use in high schools. We see tragic case after case of
disrupted teenage lives with social and family strife often
leading to mental health crises and, unfortunately, death from
overdose or suicide.
The other end of the age spectrum was revealed in an
article in the Birmingham News in May of this year. Two 66-
year-old grandmothers were charged with 12 counts of illegal
sale of prescription medications--morphine, OxyContin, and
hydrocodone--within 3 miles of a school. The director of the
local drug task force said, ``The illegal use and sale of
prescription medications has become one of the worst problems
in [the county].''
Prescription drug use is a national problem. The DEA
controls the manufacture and wholesale distribution of
controlled pharmaceuticals through a nationwide database. The
retail level, from the physician to the patient, however, is
not constantly being monitored State by State, and there is
virtually no system in place to aid physicians in identifying
unscrupulous patients trying to obtain medications under false
pretenses. Some 15 to 21 States have some form of State
prescription drug monitoring system. A monitoring system alone,
however, will not give physicians the timely information needed
to identify deceitful patients and stop diversion at its
source. An effective monitoring system must be comprehensive,
involving all 50 States, integrated, with all systems
compatible and interconnected, involving all scheduled drugs
and available in real time to give the physicians the
information necessary to make good clinical decisions.
The American Society of Interventional Pain Physicians
strongly supports NASPER, the National All Schedules Electronic
Recording Act, which incorporates all these elements and has
been tested and proven effective in Kentucky.
We ask that you support a system to give real-time,
comprehensive information to physicians prescribing controlled
substances. Help us put the control back into the Controlled
Substances Act.
Thank you again for providing me the opportunity to
present, and now I will be happy to answer any questions at the
appropriate time.
Senator Sessions. Thank you, Dr. Varley, for that excellent
testimony.
[The prepared statement of Dr. Varley follows:]
Prepared Statement Of Kenneth G. Varley, M.D.
I would like to thank Senator Sessions and all the Committee
Members and staff for this opportunity to testify regarding
prescription drug monitoring programs. I sit here in three capacities.
The first as a representative and Board member of the American
Society of Interventional Pain Physicians. Our national organization
represents nearly 50 percent of the 6,500 interventional pain
physicians in America. Interventional pain management is that
discipline of medicine devoted to the diagnosis and treatment of acute,
sub acute and chronic pain and related disorders using interventional
techniques in conjunction with other treatment modalities, including
narcotic and psychotherapeutic medications. I would like to thank our
national president, Dr. Lax Manchikanti and our executive vice-
president Dr. David Kloth for their assistance in preparing this
presentation.
The second as an interventional pain physician licensed to practice
in the State of Alabama.
The third and most important, as the father of three teenage girls,
one of whom, Elizabeth, is present today to observe these proceedings.
My thoughts and prayers are with those in Alabama and the gulf
coast who are recovering from the devastation of hurricane Ivan. The
cost and destruction of Ivan, however pales in comparison to the effect
of prescription drug abuse and diversion in our society. I have
provided supporting data and an extensive review in my formal
submission.
Today chronic pain requiring treatment affects 10-30 percent of the
population. Pain is second only to the common cold as the most frequent
presenting complaint to a physician. Narcotic analgesics and
psychotherapeutic medications made available through our pharmaceutical
industry have brought the treatment of pain within our grasp. Congress,
in its wisdom, saw fit in 1970, to pass the Controlled Substances Act
to control the manufacture and distribution of pharmaceutical
substances. Unfortunately, despite this legislation, the diversion of
legitimately prescribed medications has become such a problem that John
Walters, Director of the White House Office of National Drug Control,
stated that ``The non-medicinal use of prescription drugs has become an
increasingly widespread and serious problem in this country, one that
calls for immediate action.''
While most Americans recognize the risk of addiction and even death
from illicit drugs, they are less likely to recognize the risks of
prescription drugs. With increasing frequency, Americans have sought to
divert prescription drugs for non-medicinal purposes through theft,
fraud and forgery. With only 4.6 percent of the world's population the
United States consumes 80 percent of the world's opiod production. The
problem of prescription drug diversion has eclipsed illicit drug use as
a public health and law enforcement challenge.
Eleven million persons abused psychotherapeutic or analgesic
medications in 2003 second only to marijuana as the leading category of
illicit drugs. The exponential rise of the diversion of controlled
substances is best exemplified by the non-medicinal use of Oxycontin (a
time release pain killer similar to morphine). In 1997 221,000 persons
abused this drug but by 2003 this number had grown to 2.8 million.
Abuse of these drugs in the chronic pain population is estimated to be
between 18 and 24 percent. The diversion of prescription medications
cuts across all parts of society without regard for race, religion,
gender, age or national origin. Several years ago I performed a routine
urine drug screen on a 67 year old male suffering from post surgical
back pain. I was prescribing Oxycontin 40 mg 3 times a day but only
methadone could be found in his urine. He was selling his Oxycontin,
which was paid for by his insurance company, and buying methadone,
which is much cheaper, to control his pain. The profit amounted to a
$3,000 per month supplement to his retirement income.
Although most of the 30 million chronic pain patients are honest,
from 3 to 8 million persons a year are trying to deceive physicians and
divert prescription drugs. Unfortunately, the availability of diverted
prescriptions is no more apparent than in our schools. Evidence shows
that drugs are available as early as middle school and there is
widespread sale and use in high schools. We see tragic case after case
of disrupted teenage lives with social and family strife often leading
to mental health crises and unfortunately death from overdose or
suicide.
The other end of the age spectrum was revealed in an article in the
Birmingham News in May of this year. Two 66 year old grandmothers were
charged with 12 counts of the illegal sale of prescription medications,
(morphine, Oxycontin and hydrocodone) within three miles of a school.
The director of the local drug task force said, ``The illegal use and
sale of prescription medications has become one of the worst drug
problems in (the county).''
Prescription drug use is a national problem. The DEA controls the
manufacture and wholesale distribution of controlled pharmaceuticals
through a nationwide database. The retail level, from the physician to
the patient however, is not constantly being monitored State by State
and there is virtually no system in place to aid physicians in
identifying unscrupulous patients trying to obtain medications under
false pretenses. Some 15 to 21 States have some form of State
prescription drug monitoring system. A monitoring system alone however,
will not give physicians the timely information needed to identify
deceitful patients and stop diversion at its source. An effective
monitoring system must be comprehensive, involving all 50 States,
integrated, with all systems compatible and interconnected, involving
all scheduled drugs and available in real time to give the physicians
the information necessary to make good clinical decisions.
The American Society of Interventional Pain Physicians strongly
supports NASPER, the National All Schedules Electronic Recording Act
which incorporates all these elements and has been tested and proven
effective in Kentucky.
We ask that you support a system to give real time comprehensive
information to physicians prescribing controlled substances. Help us
put the control back into the Controlled Substances Act.
Thank you again for providing me with this opportunity. Now, I will
be happy to answer any questions you may have.
Statement Of Kenneth G. Varley, M.D.
SUMMARY
PRESCRIPTION MONITORING PROGRAMS
1. The management of pain is becoming a high priority in the USA.
2. Controlled substance abuse and diversion is becoming a high
priority.
3. Drug abuse and diversion as a national problem.
4. Drug abuse in chronic pain is a national problem.
5. Management of abuse and diversion of controlled substance is a
public health issue.
6. Current state of affairs dictate the need for prescription
monitoring programs.
7. Problems facing physicians, patients, and law enforcement.
8. The need for a comprehensive strategy to control drug abuse and
diversion is increasing.
9. National versus State control of controlled substances.
10. A national program is feasible and cost-effective.
The American Society of Interventional Pain Physicians is an
organization representing interventional pain physicians and other
health care professionals involved in interventional pain management.
Our membership is over 2,900 at the present time. It is estimated that
there are 6,500 interventional pain physicians across the country
practicing interventional pain management. Interventional pain
management, as per NUCC, is defined as--``the discipline of medicine
devoted to the diagnosis and treatment of pain related disorders
principally with the application of interventional techniques in
managing subacute, chronic, persistent, and intractable pain,
independently or in conjunction with other modalities of treatment.''
As interventional pain physicians, our members are involved extensively
in prescribing controlled substances, even though not to the same
extent as non-interventional pain physicians whose mainstay of
treatment of chronic pain is controlled substances.
1. The management of pain is becoming a high priority in the USA.
Chronic pain is prevalent in 10 percent of the population
by conservative estimates and as high as 30 percent by liberal
estimates.
In the last several years, health policy-makers, health
professionals, regulators and the public have become increasingly
interested in the provision of better pain therapies.
The United States population (294,277,501) constitutes 4.6
percent of the world population (6,392,884,741).
However, the United States with 4.6 percent of the
world population consumes 80 percent of opioids from the world.
Chronic pain involves multiple regions. After the initial
onset of pain, more recent evidence shows that as many as 60 percent of
the patients may continue to suffer with chronic pain after 1 year or
even 12 years. This applies to children also.
2. Controlled substance abuse and diversion is becoming a high priority
Non-medical uses of psychotherapeutics as described in
multiple surveys include non-medical use of any prescription type:
Pain relievers
Tranquilizers
Stimulants
Sedatives
This category does not include over-the-counter substances.
This interest in managing chronic pain has led to the
explosion of prescription of controlled substances, fueled by:
Pharmaceutical companies providing marketing and
gifts.
Numerous organizations providing guidelines and
standards.
Patient advocacy groups demanding opioids for benign
pain.
Enactment of Patient's Bill of Rights in many States.
JCAHO regulations mandating monitoring and appropriate
treatment of pain.
Patient's right to pain relief.
Easy availability on internet.
Perception of safety of prescription drugs.
While the true extent of prescription drug abuse and
diversion is unknown, estimates from a national survey indicate that
the principle drug of abuse for nearly 10 percent of U.S. patients in
treatment is a prescription drug.
The most commonly abused drugs include oxycodone
(Percodan, Percocet, Roxicet, Tylox, OxyContin), hydrocodone (Vicodin,
Vicoprofen, Lorcet, Lortab), hydromorphone, morphine (Astramorph,
Duramorph, MS Contin, Roxanol), codeine, clonazepam (Klonopin),
alprazolam (Xanax), lorazepam (Ativan), diazepam (Valium) and
carisoprodol (Soma).\1\
---------------------------------------------------------------------------
\1\ 2003 National Survey on Drug Use and Health (NSDUH). Results
from the 2003 National Survey on Drug Use and Health: National
Findings. Department of Health and Human Services.
---------------------------------------------------------------------------
Prescription drug abuse ranks second behind marijuana.
John Walters, Director of the White House Office of
National Drug Control Policy, said ``the non-medical use of
prescription drugs has become an increasingly widespread and serious
problem in this country, one that calls for immediate action.''
Emergency room visits resulting from the abuse of narcotic
pain relievers have jumped 163 percent since 1995.
The proposed 2005 budget from the White House for
prescription drug diversion control will increase by $20 million to
$138 million. Most of the funds will be directed at reducing the non-
medical use of prescription drugs, mainly opioids.
3. Drug abuse and diversion as a national problem
Results from the 2003 National Survey on Drug Use and Health showed
the following:
An estimated 6.3 million persons were current users of
psychotherapeutic drugs taken non-medically, representing 2.7 percent
of the population aged 12 or older.
An estimated 4.7 million used pain relievers, 1.8 million
used tranquilizers, 1.2 million used stimulants, and 0.3 million used
sedatives.
Pain reliever use has increased from 4.4 million in 2002
to 4.7 million in 2003.
There was a significant increase in lifetime non-medical
use of pain relievers between 2002 and 2003 among persons aged 12 or
older, from 29.6 million to 31.2 million.
Specific pain relievers with statistically significant
increase in lifetime use were hydrocodone products from 17.6 million in
2002 to 21.4 million in 2003.
Increases for OxyContin were from 1.9 million in 2002 to
2.8 million in 2003. The following shows gradual increase of OxyContin
over the years.
An estimated 18.2 percent of unemployed adults aged 18 or
older were current illicit drug users in 2003 compared with 7.9 percent
of those employed full-time and 10.7 percent of those employed part-
time.
Non-therapeutic use of pain reliever incidence increased
from 1990 (573,000 initiates) to 2002 (2.5 million).
There was a significant increase from 2002 to 2003 in the
number of persons aged 12 or older with lifetime non-medical use of
pain relievers, from 29.6 million to 31.2 million.
There was an increase in past month non-medical use of
pain relievers, from 4.1 percent in 2002 to 4.7 percent in 2003.
New non-medical users of pain relievers have been
increasing steadily since 1965 to 2002.
The rate of current illicit drug use among youths aged 12
to 17 was 11.2 percent in 2003.
Dependency or abuse of specific substances among past year
users of substances is high for prescription drugs, second only to
heroin.
Treatment for substance for which persons aged 12 or older
received treatment in the past year is high based on 2003 survey.
Prevalence of mental illness is almost double in patients
with drug abuse.
4. Drug abuse in chronic pain management is a national problem
The prevalence of chronic pain is estimated to be similar
in all countries.
Yet, the U.S. constituting 4.6 percent of the world
population is consuming 80 percent of the opioids (Patricia Good--DEA
Office of Diversion).
An increasing number of studies have documented the
relatively high incidence of controlled substance abuse and illicit
drug use in patients undergoing treatment for chronic pain.
The overall prevalence of controlled substance abuse in
interventional pain management practice settings has been shown to be
18 percent to 24 percent.
Overall, illicit drug use in chronic pain patients has
been shown to be 14 percent to 16 percent in patients without
controlled substance abuse, and 34 percent in patients with controlled
substance abuse.
With conservative estimates of chronic pain of 10 percent
in the United States (approximately 20 to 25 million persons), the
prescription drug abuse or misuse is seen in 18 percent to 24 percent
(approximately 3 million to 8 million persons).
Almost all (90 percent to 95 percent) of the patients
presenting for evaluation in interventional pain management settings
are already on heavy doses of controlled substances and we are unable
to take them off of these drugs.
5. Management of abuse and diversion of controlled substance is a
public health issue
The diversion and abuse of prescription drugs are
associated with incalculable costs to society in terms of addiction,
overdose, death, and related criminal activities.
The DEA has stated that the diversion and abuse of
legitimately produced controlled pharmaceuticals constitute a multi-
billion dollar illicit market nationwide.\2\
---------------------------------------------------------------------------
\2\ 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/prescription-
monitor/summary.htm).
---------------------------------------------------------------------------
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 and
increasing.
Numerous methadone deaths have been reported.
Patients may be receiving Schedule II, III, and IV
prescriptions from multiple practitioners who are unaware of the
potential for drug interactions or of the potential for abuse, and
diversion of certain medications.
Drug spending is skyrocketing. Significant amounts of
Medicaid funds are spent on abused drugs. Drug spending in some States
has increased by 65 percent in 2003.
Source of payment for specialty treatment or drug abuse
and addiction treatment is highest for Federal funds:
Projected economic cost of drug abuse for 1998 through
2000 has been shown by Levin group as 143.4 billion for 1998, 152.5
billion for 1999, and 160.7 billion for 2000.
The Office of the National Drug Control Policy estimated
the economic cost of drug abuse in the United States from 1992 to 1998
with overall cost of drug abuse to society increasing at a rate of 5.9
percent annually with healthcare costs of $14.9 billion in 2000.
A 1995 study by the Center on Addiction and Substance
Abuse of the cost of substance abuse to Federal entitlement programs
found that healthcare and disability costs alone were 17.6 billion,
representing nearly 20 percent of the Federal healthcare budget. In
this study, the cost to the Medicaid program resulting from substance
abuse were enormous--in 1994, accounting for almost $8 billion in
Medicaid expenditures.
A significant number of Medicaid recipients have been
shown to abuse drugs varying from 9.4 percent to 16.14 percent in the
Medicaid program, with prevalence of 15.5 percent functional impairment
due to drug abuse.
A 2004 study by the Luo et al. (Spine 2004) showed that
there was an increased risk in women and patients of low economic
status for non-medical use of psychotherapeutic drugs. These factors
are important in Medicaid as the majority constitute women and men of
low socioeconomic status.
In a study performed by Manchikanti et al. (Kentucky
Medical Association Journal--in press), patients on Medicaid as their
primary insurance or in conjunction with Medicare showed significant
incidence of drug abuse.
Patients covered by third party insurance showed 17
percent prevalence of illicit drug use, with patients on Medicare with
or without third party insurance, showing 10 percent illicit drug use.
Patients on Medicare and Medicaid showed illicit drug
use in 24 percent.
Patients only on Medicaid showed illicit drug use in
39 percent of the patients.
Combined use of illicit drugs and misuse of
prescription drugs was seen in 60 percent of the patients only on
Medicaid and 40 percent of the patients with Medicare and Medicaid.
6. Current state of affairs dictate the need for prescription
monitoring programs
The increasing diversion of prescription drugs for illegal
use is a disturbing trend in the Nation's battle against drug use and
abuse.
Prescription drug diversion is the channeling of
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.
States have recognized the need for monitoring of
controlled substances since 1940 with implementation in California
followed by Hawaii in 1943 (Table 1). Now, 15 States have such
programs, which include California, Hawaii, Idaho, Illinois, Indiana,
Kentucky, Massachusetts, Michigan, Nevada, New York, Oklahoma, Rhode
Island, Texas, Utah, and Washington State.
Florida and Virginia are actively pursuing such programs.
GAO in its May 2002 report of State monitoring programs
concluded that:
They indeed provide an efficient tool for stemming the
growing problem of illegal diversion of prescription drugs.
They offer quick access to comprehensive information
on drugs most likely to be abused and deter abusers from doctor
shopping within the State.
Incidences of drug diversion, however, are on the rise
in neighboring States, indicating the problem is proliferating or
shifting to States without monitoring programs.
The programs have helped reduce availability of abused
drugs in Kentucky, Nevada, and Utah.
State prescription monitoring programs reduce expenses to
healthcare officials, pharmacists, and law enforcement officials.
State programs have helped shorten investigation time and
reduce illegal drug diversion.
7. Problems facing physicians, patients and law enforcement
i. Problems facing physicians
Every day a physician has to consider:
Litigation for failure to treat pain
Litigation for undertreatment
Criminal charges for abuse, addiction, or death
Numerous Federal regulations
State Board of Medical Examiners
Drug Enforcement Agency
State Bureau of Narcotics
State Board of Pharmacy
Problems in Alabama
Based on the DEA fact sheet of 2004, Alabama continues
to see an increase in diverted pharmaceuticals across the State.
OxyContin is still the number one pharmaceutical drug
abused across the State.
The sale and production of Vicodin has increased in
recent years slightly, along with the illegal use of the drug.
In addition, current intelligence and investigations
indicate that Alabama is a major market for Dilaudid. Distribution in
Alabama has increased due to the fact that the price of heroin in the
New York area has fallen dramatically causing the bottom to fall out of
the market for Dilaudid. Distribution organizations are targeting the
metropolitan areas of Alabama, as the price they receive for Dilaudid
is higher in Alabama than in the source areas.
Options for Physicians:
Referral to Pain Medicine Clinics
Clinics with mainstay treatment of opioids
Very limited resource
Rare option for Interventional Pain Specialists
Refuse to Prescribe Controlled Substances
Not an option for many practices
Inadequate treatment of pain lawsuits
Litigation for addiction
Criminal charges of murder
Surrender Schedule II DEA License
Lose many patients
Lose hospital privileges
Lose all insurance patients
Not an option for interventionalists
Benefits for Physicians:
NASPER could alert physicians about patients who are
drug shopping.
Physician can make more informed decisions on
prescribing, leading to less risk for medical license.
Decreased hassle factor with DEA, Medical Board and
U.S. Attorneys.
ii. Problems facing patients
Undertreatment of pain
Suspicion may not be resolved
Patients who are drug shopping will benefit from physician
intervention.
Patients who are not drug shopping will benefit from
physician ability to feel more comfortable in prescribing medicines
they need.
Benefits for Patients:
Improved access
Stable patient-physician relationship
iii. Law Enforcement
Court cases involving possession and trafficking in
controlled substances is increasing rapidly across the Nation.
In one county in Eastern Kentucky, a 350 percent increase
was noted in 4 years.
Law enforcement officials are reporting an increasing
number of DUIs related to drugs than to alcohol.
Substance abuse residential houses are not able to cope
with the number of patients on drugs.
More than 1 in 10 inmates have been committed due to an
offense related to drugs.
The DEA, medical boards, and other authorities are
struggling to contain drug abuse and related consequences.
NASPER will benefit not only patients and physicians by
improving access to care and improving the quality of care but also
will assist law enforcement by punishing the trafficking patients, and
physicians who inappropriately prescribe or abuse drugs.
8. The need for a comprehensive strategy to control drug abuse and
diversion is increasing
While State programs have been effective, the following
deficiencies have been noted:
From 1940 to 1999, States have been able to establish only
15 functioning programs. The number of States with prescription drug
monitoring programs has grown only slightly over the past decade, from
10 in 1992 to 15 in 2002.
The White House estimates to increase drug monitoring
programs by 10 next year.
The nationwide number of prescription drug monitoring
programs has been changing. West Virginia terminated its program in
1998, but enacted legislation in 2002 to create a new program. New
Mexico terminated its program in 2000 (Figure 1).
Even though the 15 programs have a common goal of reducing
prescription drug diversion and abuse, they vary in their objectives,
design, and operation.
The major purpose of the State programs is to help law
enforcement identify and prevent prescription drug diversion.
Education objectives to provide information to physicians,
pharmacies, and the public is a secondary objective.
Very few States are proactive to the extent that
physicians can access the information proactively to reduce or prevent
abuse and diversion.
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.
Methods for analyzing the data to detect potential
diversion activity also differ among States.
Only 4 of 15 States monitor Schedule IV drugs and only 5
of 15 monitor Schedule III drugs which are the subject of major-
controlled substance abuse.
Challenges exist in establishing and expanding State
programs, due to lack of awareness of the extent to which prescription
drug abuse and diversion is a significant public health and law
enforcement problem.
Extent of diversion in abuse is not always recognized by
the States.
National efforts have focused only on providing guidance
and technical assistance.
Incidents of drug diversion, however, are on the rise in
neighboring States, indicating the problem is proliferating or shifting
to States without monitoring programs.
9. Federal versus State control of controlled substances
i. Federal
Controlled Substances Act. The Controlled Substances Act
established a classification structure for drugs and chemicals used in
the manufacture of drugs that are designed as controlled substances.
FDA regulations of prescription drugs. The FDA is
responsible for ensuring that all new drugs are safe and effective.
The DEA's regulation of controlled substances. The DEA is
the primary Federal agency responsible for enforcing the Controlled
Substances Act. The DEA has the authority to regulate transactions
involving the sale and distribution of controlled substances at the
manufacturer and wholesale distributor levels.
Guidelines for marketing drugs to healthcare
professionals. In April 2003, HHS's Office of Inspector General issued
voluntary guidelines for how drug companies should market and promote
their products to Federal healthcare programs. Federal funds are spent
through Medicare/Medicaid military health and other assistance programs
spent by patients in acquiring drugs and also in drug treatment.
Federal funds utilized for management diversion. Thus,
drugs are mostly controlled by Federal agencies rather than State
agencies.
ii. State
The State's regulation of practice of medicine and
pharmacy and role in monitoring illegal use and diversion of
prescription drugs. State laws govern the prescribing and dispensing of
prescription drugs by licensed healthcare professionals.
Multiple State agencies have responded to reports of drug
abuse. However, complete information is not available from the
directors of State Medicaid fraud control units in Kentucky, Maryland,
Pennsylvania, Virginia, and West Virginia. They stated that drug abuse
and diversion of OxyContin is a problem in these States.
State Medical Licensure Boards have also responded to
complaints about physicians who were suspected of abuse and diversion
of controlled substances, but like the Medicaid Fraud Control Units,
the Boards generally do not maintain data on the number of
investigations that were involved.
Although Medical Boards may be tough, they can't
always catch the bad apples.
Kentucky's Board of Medical Licensure ranked fifth in
the Nation for disciplining physicians in 2001.
Board reacts to complaints and can't statutorily look
for problems on its own.
In contrast, the DEA has statistics available on drug abuse and
diversion. Overall, Federal control and responsibility outweighs
States.
10. A national program is feasible and cost-effective
The cost of the program in each State varies according to
differences in their design and operational factors.
Confidentiality appears to be a major concern. Both
physicians who legitimately prescribe prescription drugs and patients
who legitimately use them are concerned that the information collected,
maintained, and monitored by State programs may be used inappropriately
or compromised.
All States, regardless of whether there is a State
prescription monitoring program or not, 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.
According to GAO, securing program funding is a critical
challenge. The 2002 report states that 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 prescription drug monitoring program.
A national comprehensive program with individual State
authority with communication among programs with uniform data
collection dispersion and ability for physicians to access the data
will reduce drug abuse and diversion and at the same time, provide
appropriate pain management. There are approximately 60,000 pharmacies
across the United States covering half a million prescriptions per
year.
A national program with a collection of State programs
will be cost effective. Table 2 shows the contiguous States for each of
the 50 States.
As per the available data from the 2002 GAO report,
describing key features of selected State prescription drug monitoring
programs as shown in Table 3, the set of funding was $415,000 in
Kentucky, $134,000 in Nevada, and $50,000 in Utah. The annual operating
costs consecutively for the 3 States was $500,000, $112,000 and
$150,000.
Table 1. Characteristics of State prescription drug monitoring programs
----------------------------------------------------------------------------------------------------------------
Controlled
substance Type of monitoring Administrative
State Year Implemented schedule(s) system Agency
monitored
----------------------------------------------------------------------------------------------------------------
California a.................... 1940.............. II................ Electronic and Pharmacy and law
triplicate form b. 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 Triplicate form b. Public health.
disciplinary
authority.
----------------------------------------------------------------------------------------------------------------
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 the 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.
Table 2. Shows the contiguous States for each of the 50 States
------------------------------------------------------------------------
State Surrounding States
------------------------------------------------------------------------
Alabama................................ Florida, Georgia, Mississippi,
Tennessee.
Alaska................................. None.
Arizona................................ California, Colorado, New
Mexico, Nevada, Utah.
Arkansas............................... Louisiana, Missouri,
Mississippi, Oklahoma,
Tennessee, Texas.
California............................. Arizona, Nevada, Oregon.
Colorado............................... Arizona, Kansas, Nebraska, New
Mexico, Oklahoma, Utah,
Wyoming.
Connecticut............................ Massachusetts, New York, Rhode
Island.
Delaware............................... Maryland, New Jersey,
Pennsylvania.
Washington DC.......................... Maryland, Virginia.
Florida................................ Alabama, Georgia.
Georgia................................ Alabama, Florida, North
Carolina, South Carolina,
Tennessee.
Hawaii................................. None.
Idaho.................................. Montana, Nevada, Oregon, Utah,
Washington, Wyoming.
Illinois............................... Iowa, Indiana, Kentucky,
Missouri, Wisconsin.
Indiana................................ Illinois, Kentucky, Michigan,
Ohio.
Iowa................................... Illinois, Minnesota, Missouri,
Nebraska, South Dakota,
Wisconsin.
Kansas................................. Colorado, Missouri, Nebraska,
Oklahoma.
Kentucky............................... Illinois, Indiana, Missouri,
Ohio, Tennessee, Virginia,
West Virginia.
Louisiana.............................. Arkansas, Mississippi, Texas.
Maine.................................. New Hampshire.
Maryland............................... District Of Columbia, Delaware,
Pennsylvania, Virginia, West
Virginia.
Massachusetts.......................... Connecticut, New Hampshire, New
York, Rhode Island, Vermont.
Michigan............................... Indiana, Ohio, Wisconsin.
Minnesota.............................. Iowa, North Dakota, South
Dakota, Wisconsin.
Mississippi............................ Alabama, Arkansas, Louisiana,
Tennessee.
Missouri............................... Arkansas, Iowa, Illinois,
Kansas, Kentucky, Nebraska,
Oklahoma, Tennessee.
Montana................................ Idaho, North Dakota, South
Dakota, Wyoming.
Nebraska............................... Colorado, Iowa, Kansas,
Missouri, South Dakota,
Wyoming.
Nevada................................. Arizona, California, Idaho,
Oregon, Utah.
New Hampshire.......................... Massachusetts, Maine, Vermont.
New Jersey............................. Delaware, New York,
Pennsylvania.
New Mexico............................. Arizona, Colorado, Oklahoma,
Texas, Utah.
New York............................... Connecticut, Massachusetts, New
Jersey, Pennsylvania, Vermont.
North Carolina......................... Georgia, South Carolina,
Tennessee, Virginia.
North Dakota........................... Minnesota, Montana, South
Dakota.
Ohio................................... Indiana, Kentucky, Michigan,
Pennsylvania, West Virginia.
Oklahoma............................... Arkansas, Colorado, Kansas,
Missouri, New Mexico, Texas.
Oregon................................. California, Idaho, Nevada,
Washington.
Pennsylvania........................... Delaware, Maryland, New Jersey,
New York, Ohio, West Virginia.
Rhode Island........................... Connecticut, Massachusetts.
South Carolina......................... Georgia, North Carolina.
South Dakota........................... Iowa, Minnesota, Montana, North
Dakota, Nebraska, Wyoming.
Tennessee.............................. Alabama, Arkansas, Georgia,
Kentucky, Missouri,
Mississippi, North Carolina,
Virginia.
Texas.................................. Arkansas, Louisiana, New
Mexico, Oklahoma.
Utah................................... Arizona, Colorado, Idaho, New
Mexico, Nevada, Wyoming.
Vermont................................ Massachusetts, New Hampshire,
New York.
Virginia............................... District Of Columbia, Kentucky,
Maryland, North Carolina,
Tennessee, West Virginia.
Washington............................. Idaho, Oregon.
West Virginia.......................... Kentucky, Maryland, Ohio,
Pennsylvania, Virginia.
Wisconsin.............................. Iowa, Illinois, Michigan,
Minnesota.
Wyoming................................ Colorado, Idaho, Montana,
Nebraska, South Dakota, Utah.
------------------------------------------------------------------------
Table 3. 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 $134,000 a in State $50,000 in one time
start-up grant funds. funds. State funds.
Controlled substance schedules II, III, IV, V......... II, III, IV............ II, III, IV, V.
monitored.
Electronic data collection and Yes.................... Yes.................... Yes.
reporting.
Private contractor receives Yes.................... Yes.................... No.
dispensing information and creates
database.
Annual operating costs (estimate).... $500,000............... $112,000............... $150,000.
Staff................................ 4 full-time (1 licensed 1 full-time with all 3 full-time including
pharmacist administrative duties. manager and 2 support
investigator, 2 staff.
pharmacy technicians,
1 data entry operator)
and 4 part-time.
Number of pharmacies reporting 1,300.................. 387.................... 375.
dispensing data (estimate).
Number of daily data requests 400.................... 20..................... 130 to 150.
received (estimate).
Report turnaround time to requestor 4 hours................ 4 hours................ 3 hours.
(estimate).
Penalty for unauthorized use or Class D felony b....... PDMP statue has no Third-degree felony.c
disclosure of PDMP data. penalty.
----------------------------------------------------------------------------------------------------------------
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.
Senator Sessions. Ms. Pritts, get that microphone there,
and we would be delighted to hear from you at this time.
Ms. Pritts. Good afternoon, Senator Sessions. I would like
to thank you and the committee for inviting me here to testify
today about the privacy considerations of prescription drug
monitoring programs.
As we have heard from earlier witnesses, there is growing
support for some Federal support for comprehensive and
compatible State prescription drug monitoring programs. This is
an admirable goal, and it appears that the State-based programs
have been fairly successful in actually reducing prescription
drug diversion and abuse. However, it is crucial to have
adequate privacy protections in place as we look to expand
these programs and to electronically link them.
My written testimony goes into quite a bit of detail about
what Federal standards should look like if the Federal
Government decides to support these programs through funding.
There should be minimum Federal standards. Many States already
have privacy protections in their State laws, but they do vary
from State to State. If you are looking to share information
across State lines, protections should be somewhat at least at
a minimum level across the board.
Now, the reason why this is necessary is that HIPAA and
other Federal privacy statutes generally do not cover
prescription drug monitoring programs. There often is a
misconception that the HIPAA privacy rule covers most people
who hold and maintain medical information, but that is not the
case.
My written testimony goes into the specific types of
standards that States should be required to follow if they
would request Federal funding, including notice; an
individual's right of access to their own information; a right
to correct that information if it is inaccurate, which is
particularly important when you are talking about this type of
information; restrictions on disclosures for recipients of
information, this is an area that actually is lacking at the
State level.
Perhaps, however, one of the largest privacy issues that I
see arising from this whole circumstance is the manner in which
identifiable data is transmitted and stored. The system that
seems to be developing seems to be based on these large
databases, either at the State level or there is some thought
of even kind of a regional level if States elect not to
participate in the system.
Maintaining data in this format has been seen by many
people in the security field as being problematic, and it is
problematic both in principle and in practice.
In principle, there are a lot of citizens in the United
States who have a visceral negative reaction to government
collecting and storing information in a central database.
Florida is a perfectly good example of that. The Florida
Legislature earlier this year tried and failed to pass a
prescription drug monitoring bill which included a central
database. The opponents compared the proposed database to
databases maintained by communist Cuba. Now, these comments
were not made by just your ordinary citizens. This particular
comment came from one of the Republican Representatives. So you
can see that there are very strong feelings on this issue by a
number of the population, and linking data and having a
comprehensive database will have to overcome those feelings in
order to be successful.
Those feelings are not just based in principle, however.
There are, as a matter of practice, some serious problems with
maintaining data in this type of database. And, unfortunately,
I am going to have to use Florida again as an example here. In
the mid-1990s, using a similar database, in Florida doctors are
required to report by name people who have been diagnosed with
AIDS, and that data is maintained in a database with
identifiable information. The patient's name, for example, is
associated with it. And a county employee downloaded 4,000
names of AIDS patients, put them on a diskette, and was using
it for his own personal dating purposes and also was basically
threatening blackmail to release it to the newspapers.
When you have information that is concentrated in this type
of a database, particularly depending on what kind of
identifiers you might have associated with it, it becomes a
very large temptation for people to act badly, not only hackers
but people who have authorized access to the information.
One of the ways that they have gotten around this issue in
the actual health care practice right now is to encrypt the
data or to have certain types of linking done. I am not a
technology expert, but I have heard presentations given,
particularly by Dr. John Halamka, who runs the New England
Health Electronic Data Interchange Network, and they have a
system there that does not require the use--you can identify
people on a need-to-know basis, but the information is not
stored using identifiers that are easily picked out by people
who would improperly access the system or improperly want to
use the system.
So I would urge as we go forward here that some of these
alternative technologies be considered. Oftentimes what happens
in this field is that we start down one path, technology
changes, and there has been a lot of commitment and money to
one path, and so people are reluctant to change. And I do
appreciate that. But to the extent that there is an opportunity
to think of other ways of doing things, this would be a good
time to start those thought processes.
Adopting these kinds of privacy protections, including
encrypting data or storing it in a nonidentifiable basis, will
ease some of the privacy concerns that people have over
establishing these programs and may ease the road into going
forward in this area.
Thank you.
Senator Sessions. Thank you very much. You raise some
matters that we need to discuss.
[The prepared statement of Ms. Pritts follows:]
Prepared Statement Of Joy L. Pritts, J.D.
I. Introduction
Mr. Chairman and Members of the Committee on Health, Education,
Labor, and Pensions: Thank you for the opportunity to testify before
you today on the need for adequate privacy protections in prescription
drug monitoring programs.
My name is Joy Pritts. I am an assistant research professor at
Georgetown University's Health Policy Institute. My work at Georgetown
focuses on laws, policies, and practices related to the privacy of
medical information.
The non-medical use of prescription drugs continues to be a
widespread and serious problem in this country. As part of the effort
to control the illegal diversion of prescription drugs, many States
have instituted prescription drug monitoring programs. These programs
collect, review, and analyze identifiable prescription data from
pharmacies. Although the programs differ in terms of objectives,
design, and operation, they generally analyze and distribute collected
information to medical practitioners, pharmacies, and regulatory and
law enforcement agencies.\1\ Many of these programs have been
successful at reducing diversion within their States. It is not
surprising that expanding the number of State prescription drug
monitoring programs and ensuring that they are able to share data
across State lines are key elements of the Federal strategy to reduce
prescription drug abuse nationwide.\2\
---------------------------------------------------------------------------
\1\ See U.S. General Accounting Office, Prescription Drugs: State
Monitoring Programs Provide Useful Tool to Reduce Diversion, GAO-02-634
(Washington, D.C. May 17, 2002).
\2\ See the White House, National Drug Control Strategy (March
2004) available online at www.whitehousedrugpolicy.gov/publications/
policy/ndcs04/index.html.
---------------------------------------------------------------------------
While the goals of these programs are admirable, increasing the
number of prescription drug monitoring programs that are able to share
identifiable information electronically raises serious privacy
concerns. Millions of Americans suffer from chronic pain. Without
adequate privacy safeguards, patients will not seek treatment and
practitioners will be hesitant to adequately prescribe medication.\3\
Absent strong privacy protections, there may well be wide-spread public
resistance to linking prescription drug monitoring program data.
---------------------------------------------------------------------------
\3\ See Gao, Prescription Drugs: State Monitoring Programs at 5.
---------------------------------------------------------------------------
II. There Should Be Federal Privacy Standards for Prescription Drug
Monitoring Programs
Federal proposals to encourage the expansion and linkage of State
prescription drug monitoring programs should establish minimum, uniform
privacy standards for these programs based on well-established fair
information practice principles. Federal privacy standards for
prescription drug monitoring programs are essential because these
programs generally are not subject to the Federal Privacy Rule issued
under the Health Insurance Portability and Accountability Act of 1996
(HIPAA Privacy Rule). The Privacy Rule only governs three major
categories of entities that maintain identifiable health information
called ``covered entities'': health care providers; health care
clearinghouses; and health plans.\4\ Most State programs are
administered by a State board of pharmacy, a State department of
health, or a State law enforcement agency. As a general rule, these
entities are not subject to the restrictions imposed by the HIPAA
Privacy Rule.
---------------------------------------------------------------------------
\4\ 45 C.F.R. 164.500 (applicability of Privacy Rule to covered
entities) and 160.103 (defining covered entity).
---------------------------------------------------------------------------
While States generally have some privacy protections for
prescription drug monitoring program data, these protections can vary
widely from State to State. For example, some States impose a criminal
penalty for unauthorized use or disclosure of prescription drug
monitoring program information and others do not. Linking data between
States with differing standards can result in decreased privacy
protections for citizens of States with stringent privacy laws.
Citizens should not lose privacy protections as a result of States'
sharing data. As a practical matter, States with high privacy standards
may be reluctant to share data with States that have less privacy
protections.
Establishing Federal minimum privacy standards for prescription
drug monitoring programs can help ease these concerns. While States
should remain the primary regulators of prescription drug monitoring
programs, any Federal funds for such programs should be tied to the
requirement that State programs meet minimum Federal privacy standards.
States should remain free to impose higher privacy standards to meet
the particular needs of their citizens.
At a minimum such Federal standards should:
Provide individuals specific notice that certain
prescription drug information will be reported to a State prescription
drug monitoring program and may be shared with programs of other
States.
Provide individuals with a right of access to their
information that is maintained in a State prescription drug monitoring
program and the right to contest the accuracy of the information.
Limit the information provided under these programs to the
minimum amount necessary to accomplish the intended purpose.
Require recipients of information from prescription drug
monitoring programs to only use the information for the purpose for
which it was disclosed and prohibit them from further disclosing the
information.
Establish safeguards for verifying the accuracy of
reported information.
Establish security standards for maintaining and
transmitting data.
Require requests for inspection from most law enforcement
agencies to be reviewed and approved by appropriate officials prior to
disclosure.
Require the de-identification of information provided for
statistical, research, or educational purposes.
Impose stringent civil and criminal penalties on the
improper use and disclosure of prescription drug monitoring program
data.
To the extent the Federal Government determines that it will
directly operate prescription drug monitoring programs, these standards
should also apply to the Federal program. The restrictions in the
Privacy Act are insufficient.
Notice
Practitioners and/or dispensers of prescription drugs should be
required to give individuals adequate notice that information related
to prescriptions for certain classes of drugs will be reported to the
State's prescription drug monitoring program. Individuals should be
informed of who will have access to this information and the purposes
for which they can use the information. Giving notice avoids any
potential of ``secret'' databases. As a practical matter, adequate
notice should also have a direct deterrent effect on ``doctor
shopping'' because potential diverters will be made aware that their
prescription drug information will be reviewed by the program and
shared with other practitioners.
Most health care providers such as doctors and pharmacists already
are required to give patients a notice of privacy practice under the
HIPAA Privacy Rule. The HIPAA Privacy Rule, however, only requires a
general notice of privacy practices that includes certain examples.\5\
To be an effective deterrent, notice under the prescription drug
monitoring program would need to specifically advise consumers that if
they have certain prescriptions filled, their prescription information
will be reported to the State monitoring program. Thus, notice under
the prescription drug monitoring program should be in addition to the
notice required by the Federal Privacy Rule.
---------------------------------------------------------------------------
\5\ See 45 C.F.R. 164.520.
---------------------------------------------------------------------------
Access
Individuals should have the right to access and contest their
identifiable data that is maintained in a prescription drug monitoring
program. The right of access ensures that identifiable information is
accurate and complete. Due to the sensitive nature of prescription drug
information, it is particularly important that data collected be
associated with the proper person.
Minimum Information
Only the minimum amount of information necessary to accomplish the
intended purpose should be disclosed to recipients of information from
prescription drug monitoring programs. This determination can be made
at the policy level. The standard should apply not only to information
that is requested of the program but also to any disclosures that are
made as a matter of routine.
Restrictions on Recipients of Information
Federal standards should require recipients of prescription drug
monitoring program information to use the information only for the
purpose for which it was disclosed. They should also prohibit
recipients from sharing the information with others. Kentucky's
prescription drug monitoring program incorporates these protections.
Integrity
The integrity of data in a prescription drug monitoring program is
vital. Programs should be required to verify the accuracy of reported
information. They should be required to either destroy old data or
convert it to an anonymous form.
Security Standards
Maintaining a system of linked electronic databases with
identifiable prescription drug information poses significant security
risks. The information is sensitive and can potentially be improperly
used against individuals. Because the information is identifiable and
available in a concentrated format, it may also prove to be a tempting
target both for hackers and for authorized personnel who may have
improper motives to access the data. The information is a potential
treasure trove for bitter ex-spouses, potential employers, and others.
Similar data has been compromised in the past. In the mid 1990's, a
Florida Department of Health employee downloaded the names of over
4,000 AIDS cases from a county computer that stored mandatory reporting
information on new AIDS cases and used the information for ``dating''
purposes. The names were also transmitted to two newspapers.\6\
---------------------------------------------------------------------------
\6\ Robert Trigaux, AIDS List is Out, St Petersburg Times 1A (Sept.
20, 1996); Editorial: Protect HIV Patients, Miami Herald Sec. L; page 2
(Oct. 13, 1996).
---------------------------------------------------------------------------
Security measures can help prevent such loss and the unauthorized
access, destruction, use, or disclosure of the data. Managerial
measures include internal organizational measures that limit access to
data and ensure that individuals with access utilize data for only
authorized purposes. Such security standards should include role-based
access and procedures for verifying that those outside the organization
who request information have the authority to access the information.
These measures should also include periodic audits to ensure that data
is being accessed appropriately. Minimum standards should also be set
for the technical protection of this sensitive data, including storing
data on secure servers and encrypting information in transmission.
Serious consideration should be given to the manner in which
information is collected and maintained in these programs. As discussed
above, central data bases with names, addresses and prescription drug
information are tempting targets for security breaches. Furthermore,
the very idea of centralized data bases elicits strong reaction among
many individuals. In the recent debate over whether Florida would
establish a central data base for prescription drug monitoring, Rep.
Rene Garcia (R- Hialeah) an opponent of the program stated, ``My
parents fled a Communist country because everything was being
centralized.'' \7\
---------------------------------------------------------------------------
\7\ David Royse, Florida Legislature: State Would Keep List of
Controlled Substance Users Under Bill-(AP) (April 15, 2004) available
at www.naplesnews.com/npdn/florida/article/0,2071,NPDN 14910
2809288,00.html.
---------------------------------------------------------------------------
Some networks that share health information utilize other methods
for linking their data. For example, the New England Health Electronic
Data Interchange Network is well-known for its network which does not
rely on a central database. Federal strategies to encourage the sharing
of data between prescription drug monitoring programs should consider
these alternative methods of exchanging data to decrease security
risks.
Access by Law Enforcement
Prescription drug monitoring programs should not permit all law
enforcement agencies unfettered access to collected data. Unfettered
law enforcement access raises concerns from consumers and physicians
that they will be improperly targeted for prosecution.\8\ Access should
be limited to agencies acting within their official duties that are
conducting bona fide criminal investigations or criminal prosecutions.
Law enforcement requests to inspect prescription drug monitoring
program data generally should be subject to review and approval by
appropriate authorities prior to disclosure. In Massachusetts, for
example, law enforcement agencies must first direct their request for
prescription drug monitoring program information to the Office for the
Attorney General or the Massachusetts State Police Diversion
Investigation Unit or the U.S. Drug Enforcement Administration for
notification and approval.\9\
---------------------------------------------------------------------------
\8\ See GAO, Prescription Drugs: State Monitoring Programs at 18.
\9\ 105 CMR 700.006.
---------------------------------------------------------------------------
Access by Researchers
Some prescription drug monitoring programs make their data
available for research or education purposes. To the extent that this
information is made available, it should be furnished only in de-
identified form.
Enforcement
Privacy protections can only be effective if there is real
enforcement. State laws vary greatly in enforcement or penalty
provisions. Some appear to provide only for minimal fines such as
$500.\10\
---------------------------------------------------------------------------
\10\ See e.g., R.I. Gen. Laws 21-28-4.09.
---------------------------------------------------------------------------
To ensure compliance with privacy standards, punishment should be
public and severe.\11\
---------------------------------------------------------------------------
\11\ See Laurence M. Welsh, Pink Slips Motivate Security
Compliance, searchsecurity.com (March 29, 2004) available at http://
searchsecurity.techtarget.com/originalContent/0,289142,sid14
gci957013,00.html.
---------------------------------------------------------------------------
Federal standards should provide for significant civil and criminal
penalties for:
Authorized personnel improperly obtaining, using or
disclosing information from a prescription drug monitoring program.
Recipient's improperly using or disclosing information
that they obtained from a prescription drug monitoring program.
Any person's improperly obtaining or using prescription
drug monitoring program information.
States should, of course, remain free to provide for private rights
of action.
III. Conclusion
Prescription drug monitoring programs appear to be an effective
tool in reducing prescription drug diversion and abuse. Minimum privacy
standards should be an essential component in any Federal programs to
encourage the expansion and interconnectivity of these programs.
Senator Sessions. Congressman Whitfield, great to see you.
I know you are having votes over at the House. We have heard
from all the panelists now. We would be delighted if you would
like to make your statement now, and maybe Ms. Pritts could
move over, and just pull your chair up. We thank you for your
leadership on this effort and for the progress that the
legislation seems to be making in the House.
STATEMENT OF WHITFIELD, HON. ED, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF KENTUCKY
Congressman Whitfield. Mr. Chairman, thank you very much. I
am quite excited about being here. I genuinely appreciate your
holding this hearing, and I certainly want to thank Ms. Pritts
for giving me her seat this afternoon.
[Laughter.]
Mr. Chairman, you are exactly right. This issue of
prescription drug monitoring plans is a vitally important issue
to our Nation. I think prescription drug abuse is a national
issue and, as a matter of public health, one that Congress must
address.
When we talk about prescription drug abuse, we are talking
about individuals using controlled substances in a manner that
is inconsistent with their prescribed use. Many people, all of
us know, live with chronic pain or have pain as a direct result
of a disease or injury. And in many cases, relief from that
pain comes only from a controlled substance. Unfortunately,
many people who are prescribed controlled substances to relieve
pain, either on a long- or short-term basis, become addicted to
them. The issue becomes how do we help prevent that abuse. And
while there are a myriad of factors that contribute to the
abuse of controlled substances, one important way we can combat
this problem is encouraging State prescription drug monitoring
programs.
Many States, as we have heard testified this afternoon,
including my own State of Kentucky, have these monitoring
programs, and I am not going to discuss the KASPER program
because I know that Secretary Holsinger from Kentucky has
already discussed our program. We think it is quite a
successful program.
While KASPER has been effective in Kentucky, there is an
inherent flaw in State prescription drug monitoring programs.
They are only effective intrastate. Kentucky is bordered by
seven States, and most of them do not have their own drug
monitoring programs. For example, in my congressional district,
we have 12 counties bordering with Tennessee, and Tennessee
does not have a monitoring program. Therefore, a physician in
Kentucky may receive a KASPER report indicating that the
patient has never been prescribed a controlled substance in
Kentucky, but they certainly do not have the access to what was
prescribed next door in Tennessee. And that is one of the fatal
flaws in our existing system.
In fact, the January 2004 Journal of the Kentucky Medical
Association concluded an article on KASPER stating that the
major problem with prescription drug information is that this
information is not available nationwide, and prescriptions
filled in out-of-State pharmacies to the KASPER system.
So I believe very strongly, Mr. Chairman, that the best way
to address this issue is by requiring all States to establish
prescription drug monitoring programs. And I have been working
with my colleagues, Congressman Charlie Norwood of Georgia and
Congressman Frank Pallone of New Jersey, on legislation
mandating that all States enact a prescription drug monitoring
program. And I am happy to say that this is one of those issues
on which there is broad bipartisan support on the House side,
and our bill, the National All Schedules Prescription
Electronic Reporting Act, called NASPER, establishes a grant
program housed at the Department of Health and Human Services
which provides States with funding to establish and operate
these programs. Our current draft requires States to cover
Schedule II through IV controlled substances, allows
practitioners and law enforcement officials access to the
information, and, most important, provide for interstate
operability. And, of course, we are quite cognizant of the
importance of privacy and are still addressing that issue, have
not resolved it completely at this time. But we did have a
hearing on this, Mr. Chairman, and I specifically asked
Secretary Tommy Thompson about creating such a program when he
testified before the House Energy and Commerce Committee last
spring, and he indicated that he supported a prescription drug
monitoring program and specifically that he would support it
housed at HHS.
With that, that concludes my testimony, Mr. Chairman. Once
again, I want to thank you for your leadership, for your
working with us, and I look forward to our continued
cooperation as we try to solve this problem.
Senator Sessions. Well, thank you for that excellent
statement and summary of the situation.
Let me ask you, Congressman Whitfield, are you finding
growing support for this in the House? I know it is always
dangerous to predict anything, but do you feel pretty good
about how the House is considering this legislation now?
Congressman Whitfield. Well, I do, Mr. Chairman. We have
worked very closely on both sides of the aisle in the Energy
and Commerce Committee with staff and with members, and things
are really coming together right now. Right now we have a
hearing scheduled--not a hearing, we actually have a markup
scheduled next Thursday with the full committee, and we
expect--recognizing what you said that you can never state with
100-percent certainty, but we feel that the bill will be
reported out of our committee at the end of next week.
Senator Sessions. I think that is a compliment to you and
the leadership that you have given to it, and maybe to the
merits of the issue. The growing States that are doing it, more
and more States are undertaking this, is a good indication
something is working, don't you think?
Congressman Whitfield. Absolutely, and it is my
understanding that the total number of States that either have
a program or are working to establish programs right now is
somewhere in the neighborhood of 31. So there is momentum out
there. There is certainly a need. And as I said, I look forward
to working with you and other Members of the Senate to help
address this problem.
Senator Sessions. Well, thank you. I would be delighted for
you to stay. You can join me here or stay there, and I have
some questions for the other members of the panel, too. And if
you have any final comments, we would welcome them.
Congressman Whitfield. Well, thank you very much, Mr.
Chairman. I would like to stay and hear a few questions and
answers, and then I am going to leave. We have a product in
Kentucky called tobacco, and we have a little hearing on that
at 3 o'clock, and so I need to get over there for that. I know
this is a health hearing, but this relates to farmers. So thank
you.
Senator Sessions. I understand. Very good.
[The prepared statement of Congressman Whitfield follows:]
Prepared Statement Of Congressman Ed Whitfield
Thank you Mr. Chairman for the opportunity to testify
before the committee on an issue that is very important.
Prescription drug abuse is a national issue and, as a matter of
public health, one Congress needs to address. President Bush
has made a commitment to curbing prescription drug abuse
through the Office of National Drug Control Policy and I know
we will make every effort to work with him on this issue.
When we talk about prescription drug abuse, we're talking
about individuals who are using controlled substances in a
manner that is inconsistent with their prescribed use. The
Federal Government exercises its authority in this area through
the Controlled Substances Act of 1970. The Act classified drugs
into five schedules based mostly on their potential for abuse.
Although Schedule I drugs, such as heroin, are not legally
available, Schedule II through V drugs are. However, the
production and distribution of these drugs, such as OxyContin,
are regulated by the Drug Enforcement Administration.
I recognize that many people live with chronic pain or have
pain as a direct result of a disease, such as cancer, and in
many cases relief from their pain comes only from a controlled
substance. It is important that those individuals continue to
have access to such drugs. Unfortunately, some people who are
prescribed controlled substances to relieve pain, either on a
long or short term basis, become addicted to them. And many
individuals who have not been prescribed these drugs illegally
obtain them as an alternative to other drugs.
We are all familiar with the problem of prescription drug
abuse and the millions of Americans who use these drugs for
non-medical purposes. The issue becomes, how do we help prevent
the abuse? While there are certainly a myriad of factors that
contribute to the abuse of controlled substances, I believe one
important way we can combat this problem is through enhancing
State prescription drug monitoring programs (PDMPs).
Many States, including my own State of Kentucky, have
PDMPs. Our system, known as the Kentucky All Schedules
Prescription Electronic Reporting (KASPER) program, is
effective. I know Secretary Holsinger will discuss KASPER in
greater detail, but to summarize, KASPER requires all
prescription drug dispensers in Kentucky to electronically
report information on Schedule II through V controlled
substances to a database operated by the State. The database
contains information on individuals who have been prescribed
any of those scheduled drugs, including the prescribing
physician, and the pharmacy where the prescription was filled.
In addition, law enforcement authorities have access to the
database under certain circumstances. This partnership of
physicians and law enforcement strikes the right balance of
treating those who have addiction problems and prosecuting
those who are breaking the law.
Physicians in Kentucky use KASPER to obtain information on
their patients to determine if they have previously been
prescribed one of these scheduled drugs. This is an invaluable
tool for doctors in determining the best treatment for their
patients. If by using KASPER a doctor discovers that a patient
complaining of pain was recently prescribed OxyContin by
another physician, and the patient failed to disclose that, it
gives the doctor an indication that their patient may have an
addiction problem.
While KASPER has been effective in Kentucky, there is an
inherent flaw in State prescription drug monitoring programs:
they are only effective intrastate. Kentucky is bordered by
seven States and (Tennessee, Missouri, Illinois, Indiana, Ohio,
West Virginia, and Virginia) most do not have their own drug
monitoring systems. For example, I have 12 counties that share
the border with Tennessee.
Tennessee does not have a PDMP. Therefore, a physician in
Kentucky may receive a KASPER report indicating that their
patient has never been prescribed a controlled substance in
Kentucky, but has no way of knowing if that individual has
received and filled a prescription in Tennessee.
Because individuals seeking to obtain fraudulent
prescriptions for controlled substances is a national problem,
I believe drug monitoring programs must also be national. A
physician in Kentucky, or any other State, should be able to
receive a report on a patient that will tell them not only if
that patient was prescribed a controlled substance in their own
State, but in any State. The January 2004 Journal of the
Kentucky Medical Association concluded in an article on KASPER
``Another problem with prescription drug information is that
this information is not available nationwide. Prescriptions
filled in out-of-State pharmacies are not reported to the
KASPER system. Patients who tend to abuse prescription drugs
may be fully aware of the limitations of the KASPER system and
seek to fill prescriptions outside the Commonwealth.''
I believe the best way to address this issue is by
requiring all States to establish prescription drug monitoring
programs. I have been working with my colleagues, Congressman
Charlie Norwood and Congressman Frank Pallone, on legislation
mandating all States enact a PDMP. Our bill, the National All
Schedules Prescription Electronic Reporting (NASPER) Act
establishes a grant program housed at the Department of Health
and Human Services which provides States with funding to
establish and operate PDMPs. Our current draft requires States
to cover schedule II-IV controlled substances, allow
practitioners and law enforcement officials access to the
information, and most important, provide for interstate
operability. I asked Secretary Tommy Thompson about creating
such a program when he testified before the House Energy and
Commerce Committee last spring and he indicated his support for
a national PDMP housed at HHS.
This is a delicate issue as it involves physician
prescribing practices and we must be certain that our efforts
are targeted at preventing the abuse while ensuring that all
Americans suffering from pain continue to have access to needed
medications. The last thing we want to do is scare doctors and
patients and create a situation where physicians are under
treating pain for fear of being arrested and patients are under
reporting pain out of the same fear. Existing PDMPs operate on
that principle by involving all stake holders such as State
medical and pharmacy boards, law enforcement, and public health
officials. I believe a system focusing on only one side of the
equation is not beneficial and yields no long term benefits.
Prevention is the goal and we must keep in mind that doctors
are the main source of these drugs. Above all else, our efforts
should be focused on preserving the integrity of the doctor-
patient relationship.
The Federal Government has a clearly established role in
this area, and any efforts to further enhance the monitoring
and distribution of controlled substances should have a Federal
component. NASPER would be an invaluable tool, especially for
physicians, in our efforts to prevent prescription drug abuse.
Senator Sessions. Dr. Holsinger, let me ask you just a few
questions first. Kentucky, as I understand it, thought you had
a fairly serious problem with prescription drug abuse before
this program was initiated, and if that is true, do you feel
that there has been any reduction in the size or scope of that
problem as a result of your program?
Dr. Holsinger. Well, I think that we have been able to see
certainly a heightened awareness of the issue, and I think that
we probably have been able to see a reduction. It is hard to
quantify because the drug of choice tends to change depending
on the enforcement around any one particular pharmaceutical
agent. So it appears that in Kentucky, where OxyContin was the
major drug of choice for abuse, that is now slipping and it
looks like it is going to slide into second or third place. So
the problem is that as you maintain control in one sphere, it
is very easy for another drug to become the drug of choice.
Senator Sessions. I remember being active in an effort to
deal with the prescription drug problem in Mobile when I was a
prosecutor, and, in fact, we made tremendous progress. Talwin
mixed with another drug was as addictive almost as heroin, and
we virtually eliminated that. That was sort of a remarkable
achievement to me. It made me come to believe that this is a
winnable war. It is hard to stop marijuana and cocaine that
comes in under the table from every area around the world and
just filters through. But prescription drugs come through
pharmacies, through doctor prescriptions. It is not that easy,
and we have laws in place that were designed to stop the abuse.
We are really not altering, as I understand it, Ms. Green,
any of the fundamental principles that we have already had. We
are just updating them with technology so they more effectively
work to stop the problem. Would you agree with that?
Ms. Green. I would, Senator. One of the things we stress is
that this is a particular database mechanism. It is a way of
expediting the collection and analysis of the information
precisely so the system can be used as a means of early
identification.
So the system itself does not actually change any
particular rules, laws, or regulations, that exist in a State.
It simply expedites the ability of all the officials in the
State and prescribers to be able to identify as early as
possible a problem and then address it as early as possible.
Senator Sessions. We do not need to be prosecuting people
if we can avoid it. There is a certain small number of just
utterly unscrupulous people that know how to forge
prescriptions or get drugs and sell them for a nice profit, as
Dr. Varley indicated. But there are a number of people who
become addicted and get driven to have that drug again and
again and again. And they lie to physicians. They go around to
multiple physicians. And that is, I think, Dr. Varley,
something that you mentioned.
Let me ask you, Dr. Holsinger said at first physicians were
somewhat skeptical of this program in Kentucky. I know in other
times in the Senate we have had pain physicians express some
concern about regulation because they were afraid it would keep
them from perhaps prescribing drugs to people who needed pain
relief. But your national group represents over half the pain
physicians in America who actually--these are the people
prescribing these painkillers on a regular basis. You strongly
support this legislation. In fact, you are pushing it. Do you
think that physicians nationwide are coming around to seeing
the value of this kind of control?
Dr. Varley. Yes, I believe that this is an important part
of providing excellent care to our patients. We have to be able
to differentiate between the legitimate and the illegitimate
patients. And we can try to do this with our history-taking
skills or doing due diligence in determining that there is an
accurate diagnosis, that the patient is actually exhibiting
pain behaviors. That is all a part of the practice of medicine.
However, we have no way of knowing whether that patient
goes to another doctor across the street or across the State
line to get other types of medications. So I think that this
will enable us to practice a higher quality of medicine to make
sure that patients who need specific drugs, whether they are
narcotics or other psychological medications, and not have to
worry that we are going to be putting that patient at risk
because of multiple medications or putting our children at risk
because the drugs are being sold in the schoolyard.
So I think that the physicians that I know, the bona fide
pain physicians who are working for the best interests of our
patients, strongly support this type of legislation.
Dr. Holsinger. Senator, I think it is fair to say that in
Kentucky, physicians today are very accepting of this and
recognize it as a major tool, as Dr. Varley has said, in their
practice in order to provide quality care to their patients.
And I think that is one of the key reasons why 85 percent of
the requests to date have come from physicians. They see the
usefulness of this information in the care of their patients,
and I think that is a real plus as we move forward into the
future.
Senator Sessions. So 85 percent of the inquiries to
determine whether or not someone has multiple prescriptions
come from physicians who are concerned about their patients. Is
that basically it?
Dr. Holsinger. That is correct. It is interesting, in our
situation only 4 percent come from pharmacists, but the
pharmacists are a key part of this; 8 percent from law
enforcement; 2 percent from the licensure board. We have had
none by court order or subpoena at this point in time, so it
has been a very effective tool for physicians.
Senator Sessions. Well, I think that does go to the point
that this is a patient treatment issue, a physician-patient
treatment issue. In other words, Dr. Varley, I have heard
physicians tell me, I have heard pharmacists tell me, I have
heard dentists tell me that people come by and they can pretty
well spot them, and they are script-getters. They come in and
complain about pain, and they are dubious immediately about it.
Some tell me, ``I just will not do it. If I have an uneasy
feeling, I will not write it.'' But that is pretty embarrassing
for a physician, is it not, a little bit difficult for the
physician who has no real proof of the problem? Does this give
a physician better information to make a better decision if he
has some doubt about the patient that is asking for pain
relief?
Dr. Varley. I think--and I brought up in my presentation--
that the timeliness of this information----
Senator Sessions. You did. You used ``real time.'' And what
do you mean by that?
Dr. Varley [continuing]. Real time so that if a patient is
in your office, that within the time, the 20 or 30 minutes that
the patient is physically present in your office, that you can
get useful information back. What we are currently doing is
routine or random urine drug screens, and what I not uncommonly
have to do, unfortunately, is when I find a patient who does
not have the drug in their urine that I am prescribing, it
generally means that they are either giving it to somebody or
they are selling it on the street. So that is currently--and
that is a reactive way of doing it. In other words, I already
prescribed the medication. They are already diverting it on the
street. And then I find out that this is going on.
So if I have a tool that will enable me to preemptively not
write that prescription, then it is better for the patient,
better for the people that would be exposed to that drug.
Senator Sessions. And if you saw a large number of
prescriptions that that patient had obtained and you knew that
they were abusing the prescription drug, would you refer them
for treatment? Would you counsel them?
Dr. Varley. I would definitely counsel the patient. We have
some patients who openly admit that they have a problem. In my
practice, I have a psychologist who works with me, and when we
identify patients with those problems, we try to direct them
either to a psychologist or an addiction specialist to try to
get them help with their problem.
Senator Sessions. Dr. Varley, the--well, I had a very good
question. It got out of my mind, and I will go to the next one
to Ms. Green. You said there was a study that was being
undertaken now that may give us some good information about how
effective this is. Would it give us any information about any
cost savings in terms of Medicaid and Medicare or private
insurance carriers?
Ms. Green. That is correct, Senator. The National Institute
of Justice has contracted with a company to actually design an
evaluation which could then be applied to the existing State
programs to actually determine the cost-effectiveness and the
costs and benefits looking at indicators such as Medicaid fraud
costs, decreases in Medicaid fraud, even insurance fraud, what
has happened to that, decrease in investigation time, to
determine the true effectiveness of the programs, and also to
use the information as a way to constantly improve the
effectiveness of the programs.
Senator Sessions. I am a big believer that the National
Institute of Justice should help in these areas, and I will
look forward to supporting their efforts, because one of the
best things the National Institute of Justice and the
Department of Justice can do to deal with drug and crime
problems in America is provide good research information to the
States. The States can oftentimes devise their own programs,
but they are not often able to spend the money to do a major
study. So I am glad to see that is being done. Do you have any
idea when it might be completed?
Ms. Green. I know that the evaluation design itself is
supposed to be completed by the end of the year. After that,
they will then begin the evaluation process, which to my
understanding this could occur anywhere over the next 9 to 12
months. But that has not been decided definitively yet.
Senator Sessions. Ms. Pritts, the question of a database a
legitimate one. If it is easy for a physician to get
information or if it is easy for law enforcement or a
pharmacist, or the licensure board to get information, it could
also be easier to disseminate that information.
First, let me ask Ms. Green and Dr. Holsinger, are you
aware of any abuses of systems that you are aware of around the
country or in your State?
Dr. Holsinger. We are not in Kentucky, Senator. We have, we
think, pretty stringent sanctions on the inappropriate or
illegal use of this kind of information. As I said, to use it
illegally is a Class D felony. That is 1 to 5 years in prison.
It is a real effort to make sure that we do use it only
appropriately. And we have chosen to build into our system the
HIPAA privacy pieces to it in an effort to be able to make sure
that we are making at least--having a system that is HIPAA-
compliant.
Senator Sessions. And that had not made--has there been any
problem in the operation of the system?
Dr. Holsinger. It has not at this point in time. We have
one outstanding issue, as we are finalizing the development of
our electronic system, that will take us to 15-minute
turnaround time for physicians. And we are waiting for an
opinion from our general counsel's office as to whether or not
we have to treat law enforcement as a business partner under
HIPAA regulations. If we have to treat them as a business
partner under HIPAA regulations as we apply them in this
system, that will cause some constraints on our law enforcement
efforts, I think. But we do not have an answer to that question
at this time yet.
Ms. Green. Senator, none of the existing operating
programs, including those that have been operating since 1939,
have had any successful claims based on inappropriate
disclosure of information or inappropriate use of the
information by the operating system.
Senator Sessions. Now, Ms. Pritts, right now pharmacists,
and, overwhelmingly, most pharmacists, have a computerized
system, bar code, or whatever that clocks in the--I guess they
clock in and inventory their drugs when they come in, and they
are inventoried as they go out at the checkout counter or the
cash register. That is available to, I guess, abuse of anybody
who has access to that system in that pharmacy. This would
create access to all of that information at one central State
source that could be accessed by doctors throughout the State.
So my understanding is that your concern is it would be
easier for a person to explore the system if they could
penetrate that if you have a statewide system. Is that your
concern?
Ms. Pritts. Well, it is the size--there are a number of
issues here. One is the size of the database. As you include
more people, it becomes more tempting for people to hack into.
Information is very valuable, especially in today's economy.
And there was a recent situation up in Canada where somebody
stole a Canadian online pharmacy, their database, and then they
tried to sell it to people at a profit.
So, similarly, when you have a lot of information in one
place, particularly if it is information that people might be
embarrassed about or would prefer not to have made public, it
becomes almost like candy in a candy store for some people who
would like to either hack into that information just for fun or
because there is somebody that they might have a vendetta
against and they think it might be in there, people who are
just on fishing expeditions, too. So the bigger it is, kind of
the more attractive it can be.
Dr. Holsinger was talking about the privacy protections
they have in place in Kentucky, which sound like they are quite
stringent, and there are a number of other States that also
have those types of protections. And it would be good if
everybody had the same level of protection.
We had the same situation just with regular medical
information prior to HIPAA. There was a lot of it that was in
paper format. People recognized as you move it into an
electronic format, you are dealing with a different kind of
animal. If you want a copy of the data, you don't have to xerox
thousands of pieces of little prescription pads. You just hit a
mouse button, and you have it.
Senator Sessions. It is very, very difficult in a State
system that is not automated to get information. For example,
cases I have seen and investigated, investigators may have to
go find paper records at Pharmacy A and go around and check
virtually every pharmacy in town because they do not know which
one the abuser used. So it is almost--that is one reason it is
so intimidating, that very seldom do we do that, so you have
got to balance the danger of a concentrated thing to have some
privacy dangers there against basically the workability of the
entire system that we have created. Would you agree that is
what we are wrestling with?
Ms. Pritts. I do agree that balancing is a very difficult
act, and there are systems in place where they do this quite
effectively on a fairly real-time basis with doctors where they
do not use a central database. And I think those are at least
worth investigating as an alternative.
People are very--the American public is--there is a big
section of the American public that is very concerned about the
development, the continued development of these large databases
with a lot of identifiable information in them. There are a
number of people who see the black helicopters circling every
time you mention government, the government getting involved in
this, and particularly with the Federal Government getting
involved in it. I think that those present real road blocks.
Senator Sessions. I do not think there is any doubt that
people are worried. I will say this, though. I do not find a
lot of people coming up to me that say on the HIPAA or other
regulations that this hospital violated my privacy or this
insurance--in theory, they are concerned about the possibility,
but I am not seeing a great uproar to me about specific
instances of privacy violation.
Dr. Varley, you said something interesting that you often--
or how often do you prescribe a urine test on your patients?
And why do you do that?
Dr. Varley. I feel like I am Detective Colombo sometimes.
We have suspicions. Part of it comes from the assessment of the
patient when they come in. What are their subjective
complaints? How severe and where is there pain? Does it make
physiologic sense? When we do a physical examination, does it
correlate with their complaints? And then there is that
unwritten, unspoken feeling that you sometimes get, you know,
you are suspicious.
We do both routine and random drug screens on patients.
Certainly the drug of choice, as I said in my presentation,
appears to have been OxyContin, but other drugs--certainly
Dilaudid was mentioned and hydrocodone and methadone. All of
those drugs have the potential for abuse.
So I basically do the urine screens as part of what I
consider the good practice of medicine to identify those
patients who are abusing my services and the health care system
and diverting the medications.
Senator Sessions. What do you find when you do the--what is
a concern? What do you often find when you do one of those
screens?
Dr. Varley. Being an Attorney General in the past, you
probably realize how can you tell when a drug addict is lying?
Their lips are moving. They will deny--you know, you show them
the--I show them the report. I do not tell them. I show them
the report. And they will deny, and they will come up with all
sorts of different explanations for why the drug is not in
their urine. And I have seen probably most of the stories or
heard most of the stories about why it is not in there.
Senator Sessions. But that helps you--you do not call the
police and say come arrest them at that point?
Dr. Varley. Personally, I feel that would be a conflict of
interest in my physician-patient relationship.
Senator Sessions. Your goal is to try to stop the bad
behavior and help your patient. Is that correct?
Dr. Varley. No, in my narcotics agreement that I have with
my patients, they give me the right, once I prescribe
medications, that should a law enforcement officer come and ask
to see their medication records--now that does not mean that
they get access to the full medical record but just their
medication records--then they give me the right to give that
information to that law enforcement officer. So we provide that
information if they are under investigation from probable cause
out in the community.
Senator Sessions. And the association, ASIPP, that you
belong to believes that in your experience of dealing on a
daily basis with people suffering from pain and understanding
and seeing the reality of the addiction problem in America,
that this kind of system that they are doing in Kentucky and
other States is humane and beneficial and helpful in treating
people and helping people to avoid addiction problems.
Dr. Varley. I think that there may be three different types
of patients that we are dealing with here: Patients who have
legitimate pain conditions that are being appropriately
treated, let's not try to discourage physicians from
appropriately treating those. We have other patients who have
an addiction problem; their problem is not pain, their problem
is addiction. So to practice good medicine we have to get them
into a program that will address their addiction. And then
there is a third group and, quite frankly, they are outright
criminals. They are obtaining drugs fraudulently and making a
buck off of other people's misery.
Senator Sessions. Well, they do need to be reported to the
police. I think you are correct.
You mentioned young people. After I ceased being a
prosecutor, not long before I became a Senator, I got asked to
represent a young man who had been president of his high school
senior class, had been injured in sports and had knee pain, and
was getting scripts passed all over town, and it said one
refill, he would raise it to seven, and things like that. It
was really sad, very sad.
Do you think that young people might be reluctant to try
cocaine or heroin, but be less afraid of prescription drugs and
get in trouble with them more than we would suspect?
Dr. Varley. I think that there is a tendency to that. I
think it is a matter of availability, it is a matter of
education, and maybe physicians, we should take a more active
role in our school system to educate our young people about the
dangers. And, unfortunately, I have a report similar to the one
you told us here 2 weeks ago. I was talking to my wife just
before we came into the committee, and she called to tell us
that an acquaintance of one of my other daughters, who is
attending Auburn University, died of a methadone overdose. And
that is something that just happened yesterday. And so, I mean,
this is a real problem. It is affecting people in all avenues
of society, and particularly--this young person had a future
ahead of them. They would have been very productive. And,
unfortunately, they got caught up in this illicit prescription
drug use and died in the process.
So I think we do have to educate. We have to decrease the
demand for these drugs as well as to decrease the availability
of them.
Senator Sessions. Would any of you have anything further to
add? Dr. Holsinger?
Dr. Holsinger. Thank you, Senator. I was just going to add
that an individual who ends up abusing prescription drugs has
to start some time. They do not start at a full-fledged abuse
situation. A system like ours, electronically operated with 15-
minute turnaround time for a physician, in other words, real
time, an opportunity to know what is going on, I believe will
give us the opportunity to have early intervention as well and
be able to identify individuals who are initially starting the
types of behavior that indicate that they are abusing these
kinds of substances and, therefore, have an opportunity for
much earlier intervention than having to deal with the backlog
of individuals that we are identifying now that have had
longstanding issues.
Senator Sessions. Well, that is exactly my thinking,
because we need to stop this before they become seriously
addicted. You know, you can get habituated to a drug, but if
you can find it early enough, perhaps they are not as addicted
and it is so hard to quit. I dealt with a witness in a case,
and he just could not stop--could not--I mean, he would go into
a frenzy to have another fix of drugs. And, also, they can get
arrested. Also, if they are not stopped early, then they have
to go through a long and expensive treatment program. Families
can break up. People can lose their jobs. They can abuse their
spouses. Children get abused with people who are addicted to
drugs. Or they use their money up. They become financially
unable to pay their bills and take care of their families.
So I think that there is a human need out there that is
very significant. It strikes me that since we are keeping all
these records anyway, everybody has to keep them--the
pharmacist, the doctor--and DEA and other places can review
them and all of that. We might as well keep them in a way that
the physician can have access to them and maybe intervene and
stop this kind of problem in the future.
Any other comments? Ms. Green?
Ms. Green. Yes, Senator. I would just like to build on the
conversation by suggesting that in order for a PMP to be as
effective as possible in intervening at an earlier stage of
someone's addiction, States will need to be willing to dedicate
sufficient treatment resources so that once these people are
identified as needing treatment, there is somewhere to send
them, meaning an appropriate treatment program.
Senator Sessions. I tend to agree with that. There are a
lot of avenues to deal with addiction absent long-term, highly
expensive institutional treatment. We are trying to get some
studies done by the National Institute of Justice on some of
those programs, how well they work and what is the best to
spend limited resources on. But obviously the best thing is not
to be addicted to begin with, stop it to begin with.
Anything else?
[No response.]
Senator Sessions. Thank you for your comments and your
remarks. One thing, if we do have sufficient funding, Ms.
Pritts, perhaps we will be better able to meet some of the
ideas and suggestions you have to make the system better. I
think a number of the suggestions you made on privacy issues
could be adopted with not a lot of expense and might be very
practical as the State goes forward. So we thank you for
sharing that with us.
We will leave the record open. I know Senator Dodd had
requested to be able to submit a statement. We will keep the
record open until close of business tomorrow.
[The prepared statement of Senator Dodd follows:]
Prepared Statement of Senator Christopher J. Dodd
Mr. Chairman, I want to thank you for holding a hearing on
the issue of abuse and diversion of prescription drugs. I am
hopeful that this hearing will shed some light on the severity
of this problem in our country and provide a forum for
discussion about solutions to the problem, including the
establishment of a Federal Prescription Monitoring Program
(PMP).
More than six million Americans use prescription drugs for
non-medical purposes. The majority of prescription drug abuse
occurs with pain relievers. While these drugs are absolutely
critical for the millions of Americans suffering from chronic
pain, if used improperly they can lead to addiction.
The potential for abuse of these drugs presents a serious
challenge. We certainly do not want to prevent physicians from
prescribing them to patients. Access to pain relief improves
the quality of life for millions of Americans, many suffering
from serious and debilitating illnesses. At the same time,
abuse and diversion of these drugs ruins lives, destroys
families, and results in thousands of deaths each year.
Prescription drug abuse is also becoming a disturbing trend
among youth. Among 18-25 year olds, only marijuana is abused
more frequently. Just over a week ago, an 18-year-old in New
Fairfield, Connecticut died after overdosing on a prescription
pain medication.
Much of the testimony at today's hearing will focus on the
use of PMPs to reduce prescription drug abuse. It is my belief
that monitoring programs have the potential to be an enormously
valuable tool in our fight to reduce prescription drug abuse,
and I applaud this committee for taking a close look at this
approach.
At the same time, any successful program to combat
prescription drug abuse must keep the following principles in
mind. First, it is critical that the confidentiality and
privacy of patients are protected. We must not create a system
where PMPs are used to target patients for prosecution. Those
suffering from chronic pain should know that they can seek
relief from their suffering without jeopardizing their right to
privacy. Along the same lines, we must ensure that physicians
can continue to appropriately prescribe these medications
without undue fear that they will run afoul of law enforcement.
PMPs should be used to help physicians identify patients in
need of help and direct them to the appropriate services.
We also must make sure that the information in PMPs is used
appropriately. Of course, we must continue to support law
enforcement efforts to fight prescription drug abuse. Where
laws are being broken and drugs are being diverted by dealers
for sale on the streets, we should provide law enforcement with
the tools necessary to prosecute criminals. However, we must do
so in a way that respects the civil liberties that are the
cornerstone of our democracy. While PMPs can be helpful in
bringing criminals to justice, access to this sensitive
information must be carefully controlled lest it is abused.
Once again Mr. Chairman, I appreciate your willingness to
shed light on this important issue, and I thank all of the
witnesses for being here today. I look forward to working with
my colleagues to address prescription drug abuse and diversion,
while ensuring that patients can continue to benefit from
necessary medications without risking their privacy.
Senator Sessions. If there are no other comments, we will
be adjourned, and thank you so much for your excellent
testimony.
[Additional material follows.]
ADDITIONAL MATERIAL
Statement Of David Kloth, M.D.
It is my pleasure to present the committee information on what has
become an extremely serious health problem in the United States.
Prescription medication substance abuse and diversion has reached
epidemic proportions in this country. It is affecting many aspects of
our society, but perhaps most concerning, is the widespread
availability of these powerful and legal medications to children and
young adults. Each and every day another young life is claimed from
drug overdose caused by readily available and seemingly legal
medications. Millions of American adults are addicted to or
inappropriately using schedule II, III, and IV controlled substances.
My name is David Kloth, I am an actively practicing board certified
pain physician. I am the Executive Vice President of the American
Society of Interventional Pain Physicians (ASIPP), the President of the
Connecticut Pain Society, and the Founder, Medical Director and
President of Connecticut Pain Care. Each and everyday I treat patients
suffering from a multitude of different pain conditions, often using
chronic narcotic medications to help control these symptoms. As an
interventional pain physician, I have many different options available
to help treat pain. My initial approach and treatment goal is to
control an individual's pain with targeted (fluoroscopically or X-ray
guided) injections, thereby treating the pain at its source and
hopefully eliminating the ``pain generator.'' Even with such treatment,
many patients still require pain-relieving medications. Unfortunately,
some patients acquire and/or use prescription medications for non-
medical purposes. Substance abuse may lead to a given patients own
demise; even worse, when diversion of medications to our streets
occurs, it can cause tragic consequences to the innocent and unknowing.
PRESCRIPTION MEDICATION ABUSE TODAY
An estimated 4.4 million Americans used prescription pain relieving
medications for non-medical purposes in 2002. This has resulted in
hundreds of thousands of emergency room visits each year. The Drug
Abuse and Warning Network (DAWN), in a November 2003 report, showed a
210 percent increase in emergency department visits from 1994-2002 for
psychotherapeutic drugs, including opioids (narcotics) and
benzodiazapines (sedatives).
Drug diversion and abuse is associated with increased crime rates
and has a destructive effect on the family, including our children.
Neonatal units are seeing increasing numbers of ``Oxy-babies.'' There
are thousands of fatalities in the United States each year from
prescription medication overdose. The economic cost to society of
treating these individuals has been estimated in the billions of
dollars. The indirect costs through lost productivity, associated
criminal activity, accidents, rehabilitation, and family destruction
(to name just a few), is difficult to measure. One study by the Office
of Management and Budget, estimated costs associated with drug abuse in
the United States at $300 billion a year, this included the expense of
government anti-drug programs and the costs of crime, healthcare,
accidents, and lost productivity.
During 2002 a questionnaire (from Monitoring the Future Study)
regarding Oxycontin usage revealed, 1.3 percent of eighth graders, 3.0
percent of tenth graders, and 4.0 percent of twelfth graders reported
using Oxycontin for non-medical reasons. In 2003, this increased to 1.7
percent, 3.6 percent, and 4.5 percent respectively. The problem is
growing. It is estimated that over 32 million Americans have used pain-
relieving medications for non-medical purposes-lifetime usage (from
National Survey on Drug Use and Health-HHS). Non-medical use of
Oxycontin has grown from 1.9 million in 2002 to 2.8 million in 2003,
and in 2004 will approach 4 million. Oxycontin's potency and its handy
distribution network--local pharmacies and the internet--have made it
more insidious and difficult to control than any other drug. A 1997
Household survey on Drug Abuse revealed that the non-medical use of
prescription drugs exceeded all illicit substances except for marijuana
and hashish. In the age group of 18-25 year old the incidence of
marijuana usage is estimated at 17.3 percent and the non-medical use of
prescription medicines is 5.4 percent.
PRIOR HELP COMMITTEE HEARINGS
In the past, the Senate HELP Committee has had hearings on
Oxycontin, prescription drug abuse and diversion. This issue is not new
to our government. NASPER is a solution to one component of this
problem, ``doctor shopping.'' NIDA (National Institute on Drug Abuse)
in prior hearings has informed the committee of the seriousness of this
problem and has directed significant attention to this problem by
encouraging research and program development for more effective
behavioral and pharmacological treatments of this problem. Abuse of
prescription drugs now ranks third in this country behind only alcohol
and marijuana.
THE LEGITIMATE TREATMENT OF PAIN
When used properly, as legitimately prescribed by the physician,
these medications are safe, effective, and medically indicated.
Controlled prescription drugs play a significant role in the proper
management of chronic pain, anxiety, depression, insomnia, and muscle
spasm. The proper and adequate control of pain has improved the lives
of millions of Americans with debilitating and painful conditions.
Prescription medications are essential to high quality cancer pain
management. However, when prescription controlled substances are
abused, misused, or diverted they can become dangerous and even lethal.
These types of inappropriate use shed a cloud over this extremely
important treatment modality, thus making it more difficult for those
who can truly benefit from this worthwhile approach. The pain community
has spent years trying to convince physicians, the public, law
enforcement and legislators about the need to improve access to this
treatment and over the last 10 years we have seen the barriers
practically disappear. Today, as many as 90 percent of the patients
seen in a pain management clinic receive narcotic pain medications
(either as sole therapy or in addition to other treatments) for the
treatment of their chronic pain. With this increased access have
unfortunately come new problems as we have seen with the rampant spread
of these medications on the streets of America.
NON-MEDICAL USE OF PRESCRIPTION MEDICATIONS
We are all familiar with the recent Oxycontin crisis, but this is
only one of the medications with which we see diversion and abuse. In
fact, hydrocodone (also known as Vicoden or Lortab) and Percocet are
more widely abused and easily obtained on our streets. Millions of
patients are addicted to and misusing these medications to the
detriment of their own health. These individuals are becoming addicted
to very powerful medications that can be legally obtained in any
pharmacy. When used for non-medical purposes, these medications are as
dangerous as heroin, cocaine, ecstasy, and other illicit drugs. Because
of their ready availability, many addicts have converted to using
prescription medications from typical street drugs. This problem and
source of drugs, has become as important, as the illicit drugs that
come across our borders.
The non-medical use of prescription drugs has blossomed into one of
the most serious health problems in this country. The wide spread
availability of these highly addictive medications through illegal
diversion and theft has resulted in a national health care epidemic.
Since these medications can be obtained through legal channels, it has
presented an extreme challenge to law enforcement in this country.
Recent statistics show that the United States consumes 80 percent of
all legal opioids produced worldwide. This is in large part due to the
high quality of our medical system and the emphasis that is placed in
this country on adequately and properly treating pain. This
availability also demonstrates why these medications have replaced
heroin and other illicit drugs as popular drugs on our streets. With
this increased availability comes increased responsibility and, hence,
the need for H.R. 3015 or NASPER (National All Schedule Prescription
Electronic Reporting Act).
DRUG DIVERSION
Prescription drug diversion can occur many ways but by far the most
common form of diversion in this country occurs via what we call
``doctor shopping.'' Those who seek to abuse or misuse medications for
their own purpose also use this approach. Doctor shopping refers to the
activity of obtaining medications from more than one physician at the
same time, as demonstrated in the recent case of Rush Limbaugh. This
source of diversion would be readily reduced, if not eliminated, by a
program such as NASPER. Currently, it is impossible in most States for
physicians to prevent this activity due to an inability to obtain the
necessary information. As the borders have been tightened, drug dealers
have discovered new ways to obtain drug supplies to push on our
innocent youth. Prescription medication abuse and diversion is a
serious problem because of the powerful nature of these pure, and
potentially addictive, medications. It is these legal prescription
medications that are now finding their way to the streets of America.
Current DEA estimates suggest that at least 4.7 million people are
using prescription medications illegally in this country. An estimated
994,000 Americans received treatment for prescription drug abuse in
2002.
THE DARK SIDE
Last week in my area, an 18 year old and recent New Fairfield, CT
high school graduate, died, from what his sisters and friends confirmed
was an Oxycontin overdose. The newspapers described him as ``a man of
great compassion . . . he was a happy boy. He had a lot of friends and
he wouldn't hurt anyone.'' To his friends and family, this is an
incredible loss; ``I'm going to hurt till the day I die'' said his
father. Let this example be a message to us all, a wake-up call that it
is within our power, the ability to decrease the availability of these
medications on the street. If we can prevent this from happening to one
other individual, what is this worth? To hundreds? To thousands? What
if this was your child? While NASPER will not completely eliminate the
street availability of all prescription controlled substances, it will
go a long way in this regard. If we can prevent our children from
trying these powerful medications, by eliminating or at least markedly
restricting their street availability, we can prevent addiction and the
horrible and possibly fatal consequences. The State of Connecticut
Medical Examiners office deals with an estimated 10-15 new overdose
deaths/week; many of these are related to prescription medications
(estimated at close to 1,000 in the last several years).
THE SUPPLIER
Four years ago, I found that one of my patients was photocopying
and forging my prescriptions. He had obtained over 4,000 Oxycontin tabs
from six different pharmacies in a 5-month period (this is what we
could track down by randomly calling pharmacies and might have been
just the tip of the iceberg). He was not taking all of these
medications but was most certainly selling them on the street,
presumably one of the biggest suppliers in his town at the time. How
many became addicted on a long-term basis because of this one
individual? We will never know. We caught him by dumb luck, but with
NASPER the pharmacist would have had access to this information and
could have stopped this before it began.
CURRENT STATE PROGRAMS
While approximately 15 States (CA, HI, ID, IL, IN, KY, MA, MI, NV,
NY, OK, RI, TX, UT, and WA) currently have some form of electronic
monitoring program (two more--VA and FL--are pursuing programs), only
two allow physicians and/or pharmacists access to this information.
Doctors are on the front line of this battle and it is our licenses
that are at jeopardy when a patient abuses or diverts their
medications. How can we be expected to properly monitor and prevent our
patients from becoming addicted to these very powerful medications if
our access to this information is restricted? These medications are
safe when used properly, but dangerous and potentially lethal when used
improperly. Many pain medications including the most abused medication
in this country, Hydrocodone, come mixed with acetaminophen (Tylenol).
Patients who take excessive amounts of acetaminophen can develop liver
and/or kidney disease.
The 15 State programs have a common goal of reducing prescription
drug abuse and diversion but vary in their objectives, design, and
operation. They do not communicate nor share information with each
other on an on-going basis. Only four of the State programs collect
information on schedule II, III, and IV controlled substances, one
collects data on schedule II and III, and the rest II only. (Schedule
II includes morphine, oxycodone-Oxycontin, methadone, etc.; schedule
III includes hydrocodone-vicoden, Tylenol with codeine, etc.; and
schedule IV includes sedatives such as Valium, Xanax, etc.). Since the
most widely abused medication in the U.S. is hydrocodone (this has been
shown in multiple studies), it is clear that the majority of State
programs inadequately address the whole problem (only 5 of 15 programs
collect information on schedule III controlled substances). Most of the
State programs were designed and implemented to assist law enforcement
in identifying and preventing drug diversion but do not allow the
physician or pharmacist to participate in this quest.
KASPER, the Kentucky program which served as the model for NASPER
was designed after, is often quoted as the most effective program in
the country. Unfortunately, due to the lack of an effective and
comprehensive program in neighboring States, this program has not fully
achieved what it is capable of. This is due to the highly mobile nature
of our society and the ease with which patients can obtain medications
in adjacent States. To be truly effective, we need a national program
with each State collecting similar data and which allows physician
access to the information from all States. I am from Connecticut and
within 1 to 2 hours can drive to six other States (PA, NY, NJ, MA, RI,
VT, NH). A single State program without exchange of information would
not completely address the problem of doctor shopping.
HAROLD ROGERS PRESCRIPTION DRUG MONITORING PROGRAM
The Harold Rogers Prescription Drug Monitoring Program, which began
to receive funding in 2002, encouraged, but did not require, each State
to institute an electronic monitoring program. It placed no
requirements on what information was to be collected (schedule II, III,
and/or IV), nor did it encourage physician or pharmacist access to this
information. There were no provisions for exchange of information
between States, due in part, to the lack of uniformity between
programs. As we have learned, those involved in prescription drug abuse
and diversion are smart and adaptable. To circumvent this solution
these individuals began to cross State lines to obtain additional
medications, often selecting adjacent States without an electronic
monitoring program. In addition, many States dealing with budget
deficits, elected not to start their own programs due to insufficient
funding through this program (one of the reasons that Connecticut has
no program). While the intentions of this program were good and
Congressman Rogers should be commended for this initial effort, we have
discovered many deficiencies, which have been addressed and dealt with
in NASPER.
DEA'S ROLE IN PRESCRIPTION MEDICATION ABUSE AND DIVERSION
The DEA is able to control diversion at the wholesale level with
regulatory, nationwide monitoring databases and investigative
activities, but cannot effectively deal with diversion at the retail
level. It simply does not and cannot have the necessary manpower to
accomplish this effectively. From a privacy standpoint, even if the DEA
could accomplish this monumental task, it would be better, and make
more sense, for the physician to monitor his/her own patients.
A Massachusetts DEA report in 2004 describes, ``well-organized
doctor shopping rings, forged and/or altered prescriptions, and
diversion from individual prescriptions are the most commonly found
diversion methods in the State.'' NASPER, through physician and
pharmacist involvement, would stop these forms of diversion. The DEA's
report on Connecticut states that ``diverted pharmaceuticals are also
prevalently abused in CT . . . the diversion and abuse of prescription
opiates such as Oxycontin, Vicoden, and Percocet are increasing
rapidly. Diverted pharmaceuticals typically are obtained through common
diversion techniques including prescription fraud, improper prescribing
practices, ``doctor shopping'', and pharmacy theft.'' In Alabama, the
DEA report states that ``Oxycontin is still the number one drug abused
across the State . . . Alabama is a major market for Dilaudid.
Distribution in Alabama (of Dilaudid) has increased due to the fact
that the price of heroin in the New York area has fallen dramatically
causing the bottom to fall out of the market for Dilaudid. Distribution
networks have targeted metropolitan areas of Alabama, as the price they
receive for Dilaudid in Alabama is higher.''
STATE MEDICAID SPENDING
It has been reported that some States have increased drug spending
within the Medicaid system by as much as 65 percent in 2003. As you are
aware, Medicaid programs provide medications at government expense to
those who cannot afford their own healthcare. The State of
Connecticut's Medicaid program spent $11.7 million on 44,500 Oxycontin
prescriptions in 2003. The State of Massachusetts' Medicaid system
spent over $20 million in both 2003 and 2004 on Oxycontin (over 80,000
prescriptions each year). In Massachusetts, Oxycontin was the seventh
most costly medication in total dollars spent and was the 26th most
prescribed medication within the State Medicaid program. Percocet was
the fourth most prescribed medication (a less expensive medication, so
in total dollars more is spent on Oxycontin). Studies have shown that
the incidence of abuse and diversion within the Medicaid systems is 2-3
times that of the general population and approaches 20 percent. In a
soon to be published study by Manchikanti et al., patients with only
Medicaid coverage showed a 39 percent incidence of illicit drug usage
as compared to 17 percent with third party insurance (Medicare patients
with/without third party coverage were only 10 percent). Combining the
use of illicit drugs and misuse of prescription medications showed the
highest incidence in the Medicaid group, 60 percent (versus 24 percent
in the Medicare group with/without third party insurance). The money
saved directly by limiting drug diversion and abuse in this population
will in itself easily pay for the NASPER program. Just as importantly,
with NASPER, we will be protecting America from at least one major
source of medication that is reaching our streets.
The majority of money spent on substance abuse comes from Federal
sources with our national drug control policy on track to spend over
$12 billion in 2005. HHS funds 32 percent of the $572 billion spent on
Medicaid (or $183 billion) programs. It is estimated that 15 percent of
the Medicaid recipients abuse/misuse prescription medications. A 1
percent savings to Medicaid will result in a saving of $1.83 billion
and more realistically this could approach 5 percent or $9 billion. A
comprehensive controlled substance monitoring program will result in
significant cost savings from this point of view alone and clearly
makes sense. The center on Addiction and Substance Abuse (CASA), in
1995, performed an extensive study of the costs of substance abuse to
Federal entitlement programs and found that healthcare and disability
costs alone were $77.6 billion. The Levin group projected the economic
costs of drug abuse in 2000 at $160.7 billion. The proposed 2005 budget
from the White House for prescription drug diversion control will
increase from $20 million to $138 million, with most of the funds
directed at reducing the non-medical use of prescription drugs.
BEYOND NASPER
More needs to be done than NASPER, but this will be a great start.
The Internet remains a major problem and will need to be addressed. I
would urge you to create a task force to deal with this rapidly growing
problem. Tens of thousands of people in this country are becoming
addicted to narcotic medications that they obtain through the Internet.
I have placed three people into rehabilitation programs who bought
their medications over the Internet and subsequently became addicted in
this fashion. We must also address the availability of qualified drug
rehabilitation programs and ensure insurance coverage for those who
have traveled down the wrong pathway. Many of the available beds in our
drug rehabilitation programs are now occupied by recovering
prescription drug addicts. Preventive medicine, as can be accomplished
with NASPER, represents the better solution, especially given the high
incidence of recidivism with this disease (estimated between 50-80
percent).
PRIVACY CONCERNS
The most common objection that I have heard in regard to NASPER has
to do with privacy issues. We have, however, taken tremendous
safeguards to protect patient's privacy. First, this program is fully
HIPPA compliant. Patients must sign a release in order for the
physician or pharmacist to obtain information. Anyone obtaining
information, other than the patient's pharmacist or physician, (or
these individuals without appropriate consent), is subject to a fine of
$25,000 per offense. Law enforcement only has access to this
information through appropriately obtained subpoenas, showing just
cause. I am frequently asked ``what about the patient who won't sign
the release of information.'' This will certainly lead to a discussion
between the patient and the physician, and of course, will raise
suspicions. Some patients may have a justified reason, others will not.
All States, regardless of whether there is a State prescription
monitoring program or not, already have the authority under State 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.
I have explained NASPER to many of my patients who are taking
chronic medications legitimately, and asked if they would object to the
government collecting this information. Uniformly they have all said
``no'', because for them it will help legitimize what they are doing
and will take away some of the stigma associated with taking chronic
pain medications. They resent being adversely labeled because of those
who choose to abuse and misuse this treatment approach. The abuse and
diversion of drugs to inappropriate sources, does as much to hurt the
treatment of pain in this country, than the under treatment that we so
frequently hear about.
THE DECADE OF PAIN CONTROL
The United States Congress has declared the decade of 2001-2010 the
``Decade of Pain Control.'' The use of chronic narcotic pain
medications to treat pain is now well accepted by most individuals in
this country. Therefore, there should not be a stigma attached to
someone who is taking these medications for medically appropriate and
indicated reasons. Abuse and diversion undermine the great efforts and
advances that we have achieved in this treatment arena. Our ability to
limit these factors will only help to foster the appropriate use of
medications for the treatment of pain.
Patients will benefit from the NASPER program by improving the
treatment of pain through reduced suspicions, increased access, and
improved physician comfort in prescribing medications. Patients who are
doctor shopping will benefit from earlier physician intervention. This
program will help to stabilize and improve the patient-physician
relationship. Law enforcement cannot possibly keep up with the
increasing number of drug sales, associated criminal activities, DUI's
and other related activities. NASPER will help law enforcement do their
job more effectively by decreasing the availability of one major source
of drugs.
STAND TOGETHER--AMERICA NEEDS NASPER
NASPER is a bipartisan piece of legislation that is good for
America and that every legislator should support. In this election
year, which has more than enough division and partisanship, we ask both
Democrats and Republicans to stand together on the important issue of
prescription drug abuse and show this country that both parties are
committed to protecting Americans. As an actively practicing pain
physician, I understand that it is important to treat pain; this is
something I do every day (I perform over 10,000 patient visits per year
in my practice), but I also recognize that we must deal with this
rapidly growing problem. While there is clearly a role for these
medications, they must be controlled and used properly or they can be
dangerous. Perhaps the pendulum has swung too far the other way. I
believe that narcotic medications are safe and medically appropriate
for the treatment of pain, provided that they are prescribed and
controlled by a single provider. This is good medicine. That doctor, at
his own choosing, can decide what is the right dosage for a given
patient; but when multiple physicians are prescribing simultaneously,
this is a prescription for disaster.
CONCLUSION
Senators, I don't care much for politics but I do care about the
right cause, and that is what makes sense for the safety of our
patients. NASPER will not only improve quality of patient care, but
also make America a safer place. We have an obligation to do whatever
we can to protect the children of our country (including my 11 and 13
year old) by reducing the supplies of prescription medications on the
streets. NASPER makes sense for this country at this time; it will
eliminate or at least significantly decrease one of the largest sources
of prescription medications being diverted for non-medical purposes. It
will help prevent patient substance abuse, decrease the chance of
addiction due to better physician medication monitoring, and lower the
number of people requiring drug rehabilitation (patients, true addicts,
and the misguided who were unlucky enough to get involved in the ``Oxy-
Craze'').
The costs are minimal to start and operate this program. In reality
the program will more than pay for itself through decreased
expenditures on medications within the Medicaid system and soon to be
available Medicare prescription benefit plans. It will also decrease
healthcare costs in terms of fewer ER visits, reduced number of rehab
program visits (long-term), and other related healthcare expenditures
(including cases of HIV). How often does a bill, supporting a new
program, actually result in a net savings? Perhaps the most important
benefit of H.R. 3015/NASPER, is its positive effects on family life, as
opposed to the destructive effects that these medications can have,
when taken improperly and for non-medical reasons. How many human lives
will NASPER save? Can we afford to continue ignoring this problem?
[Whereupon, at 3:20 p.m., the committee was adjourned.]