Witness Testimony
Danna E. Droz RPh, JD
Executive Director
Boards of Pharmacy & Nursing Home Administrators
4052 Bald Cypress Way, Bin C04
Tallahassee, FL, 32399
Prescription Drug Monitoring: Strategies to Promote Treatment and Deter Prescription Drug Abuse
Subcommittee on Health
March 4, 2004
1:00 PM
NASCSA supports the Harold Rogers Grants for Prescription Monitoring programs
and recommends continued financial support and consideration of a federal
mandate for states to develop prescription monitoring programs.
Chairman Bilirakis, members of the Subcommittee, Ladies and Gentlemen,
Good afternoon. Thank you for the opportunity to speak with you today about
topics that are very timely but hardly new, particularly to our members - abuse
of prescription drugs and prescription monitoring programs.
I represent the National Association of State Controlled Substance Authorities
(hereinafter NASCSA). NASCSA is a non-profit educational organization,
celebrating its twentieth anniversary this year. Currently we have 42 member
states, although many other people and organizations are associate members or
otherwise active in the organization. The primary purpose is to provide a
continuing mechanism through which state agencies, federal agencies, the
regulated industries and professions, and others can work to increase the
effectiveness and efficiency of state and national efforts to prevent and
control drug abuse, yet provide mechanisms to make the class of drugs known as
controlled substances reasonably available to those persons who have a true
medical need for these drugs. This is accomplished by providing a neutral forum
during the fall conference of each year, for the exchange of ideas, information,
and views on legal and regulatory issues relating to the controlled substances.
The issue of prescription monitoring programs has been a focus of NASCSA since
its inception. Some of the first conferences of NASCSA in the early 1980's
included sessions on prescription monitoring, a practice that continues to this
day.
Abuse of prescription drugs and efforts to monitor those drugs has existed
almost as long as prescription drugs. In 1939 -1940, California implemented the
first prescription monitoring program by requiring that any physician who wrote
a prescription for a Schedule II drug, such as morphine or Demerolâ had to use
a special three-part form. The physician retained a copy, the pharmacy retained
a copy and one copy was sent to the state. The information was then available
for analysis to determine if physicians or patients might be misusing or abusing
these drugs. Over the next 40 years or so, several other states adopted similar
programs which were often referred to a "triplicate prescription
programs."
In 1991, Oklahoma developed a similar program. However, instead of collecting
data on paper, they recognized that the pharmacy industry was using computers to
transfer prescription information for billing purposes. Sensing an opportunity,
the state officials developed the first electronic prescription monitoring
program. The same data was collected but no pieces of paper were involved. This
made it much easier for physicians to prescribe Schedule II controlled
substances and for pharmacists to report the required information to the state.
A virtually transparent process evolved. Over the next ten years, several more
states developed electronic monitoring programs and expanded from schedule II
only to all controlled substances. The states that formerly required triplicate
prescription blanks have now converted to electronic data collection of
prescription information. (Note: Some of the states still utilize special or
state-issued prescription blanks but not for data collection purposes.)
In 1995, NASCSA and the Alliance of States with Prescription Monitoring Programs
(hereinafter Alliance of States), a sister organization, developed and adopted
the first Model Act for Prescription Monitoring Programs. This document served
to guide states in developing new programs but allowed sufficient latitude for
each state to make modifications to address various state-specific needs. Today
we have about 22 states with programs in operation or currently being
implemented.
The members of NASCSA have always recognized that prescription controlled
substances are first and foremost, prescription drugs that are approved to treat
medical conditions. While they inherently possess the potential to be abused or
produce addiction, these drugs are absolutely necessary to alleviate pain and
treat certain other conditions. Recognizing the importance of appropriate pain
management, between 1998 and 2001, NASCSA members adopted three different
resolutions reiterating their support for the appropriate use of controlled
substances and encouraging increased education for practitioners, pharmacists,
and other health care providers surrounding the appropriate use of prescription
controlled substances for treating patients with legitimate medical conditions.
In 2002, NASCSA and the Alliance of States again collaborated on a new model
act, the "Prescription Monitoring Program Model Act of 2002." This
document addressed many of the changes in technology and needs recognized by
states with current programs. However, the goals of prescription monitoring
programs remained the same:
· Education and information - Health practitioners, as a group, receive very
little training about appropriate use of controlled substances. Prescription
monitoring programs provide an excellent platform for various groups to offer
educational opportunities for such learning.
Practitioners in those states that have programs report that the additional
information about patients' drug histories is invaluable in evaluating medical
conditions where the prescribing of controlled substances is being considered.
· Public health initiatives - Analyzing trends and sudden changes in
prescribing or dispensing patterns can provide valuable information that may
alert officials to potential diversion before it becomes an epidemic.
· Early intervention and prevention - Physicians and pharmacists who review a
patient's history of prescription controlled substances have an opportunity to
recognize the warning signs of abuse or addiction. These patients can be steered
into intervention programs or referred to treatment programs earlier in the
abuse/addiction disease process, possibly saving thousands of health care
dollars that would otherwise be required.
· Investigations and enforcement - Crimes involving prescription drugs require
very different investigative and evidence gathering techniques than those used
to investigate street drug crimes. The information available from a prescription
monitoring program can be a tool for gathering evidence by allowing an officer
to focus his/her investigation on locations where evidence is most likely to be
located. Please note that data from a program does not replace the
investigation; it merely decreases the time required to gather evidence.
· Protection of confidentiality - Every state with a prescription monitoring
program has very strict parameters about who can get access to the data, the
purposes for which it can be used, and with whom the information may be shared.
While the parameters vary from state to state, each one recognizes the
confidential nature of the information and the necessity of minimal disclosure.
It is worth noting that NASCSA members recognized the importance of patient
privacy long before HIPAA required it. A person's prescription information
should be available only to those persons with a legal need-to-know.
Today the variability in state programs is significant. Each program is
developed and implemented because of specific needs, interests, and compromises
within the individual state. Yet each program also works because it meets many,
but not all, of the needs of the agencies and persons who utilize the program.
While it would be possible to develop a program that absolutely prohibited
misuse or diversion, many legitimate patients would be denied access to the
drugs that make their lives worth living. On the other hand it would be possible
to make prescription controlled substances easily available to every person who
might potentially benefit from their use. Yet such a system would be fraught
with drug diversion. The key is balance. Prescription Monitoring Programs
attempt to strike the appropriate balance between making drugs available for
patients and limiting drug diversion.
I'd like to review the various programs currently in place or being implemented
across the country.
· Schedules of drugs monitored - Many of the states that initially had
paper-based programs using state-issued prescription blanks monitor only
schedule II drugs such as Demerolâ, Dexedrineâ, morphine, OxyContinâ,
Percocetâ, Ritalinâ, Tyloxâ, and all of their generic equivalents. Other
states have expanded to Schedules II, and III, which would cover the Lorcetâ,
Lortabâ, Tylenolâ with codeine and Vicodinâ and equivalents. Those states
that monitor Schedules II, III, and IV include all of the above mentioned drugs
plus many of the diet pills like Adipexâ and the anti-anxiety agents like
Valiumâ and Xanaxâ. Three states, Kentucky, Michigan, and Utah, monitor all
the controlled substances. While the use and abuse of schedule V drugs is not
nearly as voluminous as in Schedules II, III, and IV, it does occur. Those
states feel that it is very difficult for a state, having once implemented a
limited program, to amend its laws to expand it. Furthermore, one never knows
what new drug will appear in the marketplace and how it will be scheduled. Often
the abuse potential is not recognized at the outset. Some of you may recall that
many of our problem drugs of today were hailed at product launch as having no
abuse potential. Even some of our over-the-counter drugs are being abused and
causing deaths in young people.
· What agency operates the program - Some states house their prescription
monitoring program in a health program agency, some in a law enforcement agency
and some in a pharmacy board or similar licensing agency. Where the program is
located is often a function of the types of people that utilize the data and
what purpose the program was implemented to address. Those states that house the
program in a health agency generally use the data for health purposes such as
providing information to physicians or pharmacists who are treating patients or
health licensing boards that are investigating complaints against health care
practitioners. If the program is housed in a law enforcement agency, the state
tends to focus on prescription forgery, "doctor-shopping", or other
patient focused crimes.
· How frequently is data updated - Currently all states utilize a reporting
process called batch reporting. States require pharmacies to report the
prescriptions for controlled substances on a regular basis ranging from every
week to every month. While everyone recognizes the limitations of batch
reporting, it is still the most cost-effective way to collect this type data. Of
course real-time reporting is preferable but there are significant hurdles to
overcome, not the least of which is cost. It is also important to note that
Oklahoma used real-time reporting when their program was initially implemented.
However, they abandoned it in favor of batch reporting because they found that
its limited value was not worth the cost. In addition, there were technological
problems that prevented the data from entering the database as quickly as they
had hoped. At this point in time, real-time reporting of prescription data is a
simple concept, but it is very difficult to implement. While I was working in
Kentucky, we worked with groups of physicians as well as law enforcement
officers. The consensus was that batch reporting of data will meet 85-90% of
their needs. In the words of Dr. Steve Davis, my former supervisor, we have to
make sure "the juice is worth the squeeze."
· Who has access to the information - States have different concepts of who has
a need for patient-specific prescription information. Some states limit access
to this information to a specific law enforcement agency, some to only law
enforcement agencies, some to health care providers, including pharmacists, and
some to only physicians. Access by licensing boards that discipline health care
practitioners are sometimes considered law enforcement and sometimes health
care.
· Sharing across state lines - All NASCSA members recognize that prescription
drug abuse has no boundaries. Patients and providers alike frequently cross
state lines for a multitude of reasons, most of them legitimate. Some states are
able to share the information contained in prescription monitoring program data
bases while others are not. The 2002 Prescription Monitoring Program Model Act
supports the appropriate sharing of information between states. Many of the
states, who cannot share information at the present time, are seeking to amend
their laws to include this capability.
In 2003, NASCSA convened a workgroup composed of representatives from states
with prescription monitoring programs, DEA's Drug Diversion group, pharmacies,
third party payers and drug manufacturers. The goal of this group was to develop
standards for reporting prescription information to such programs. The group
felt that if every state required the same information to be reported, it would
facilitate:
(a) sharing information from one state to another and
(b) compliance by corporations with pharmacies in multiple states.
These reports, as well as other documents that I have referred to in my
testimony are available on NASCSA's website at www.NASCSA.org.
In summary, NASCSA members support the concept of prescription monitoring
programs and recognize the problems associated with a state-by-state
implementation process. However, there are significant issues associated with a
national data base for prescription monitoring purposes. Therefore NASCSA has
passed a resolution both in 2002 and 2003 supporting the Harold Rogers Grant
programs for states seeking legislation for a prescription monitoring program,
implementing a new program or enhancing an existing program. It is the position
of NASCSA that a federal program would be duplicative of the states efforts,
have the unintended consequence of providing a disincentive to states to
continue their programs, and limit the ability of the states to address unique
problems. NASCSA members believe that prescription monitoring programs would be
more effectively supported by Congress' financial support and possibly a mandate
for all states to develop such programs with standard features that would
facilitate sharing data among the states.
We would like to thank members of this committee for permitting me to testify on
behalf of NASCSA on this very important issue which our members have been
working on collectively for years. We look forward to collaborating with
Committee members and your staff on this issue. Since many of our members have
years of experience in the issue of prescription drug abuse and prescription
monitoring programs, we believe we are uniquely qualified by this experience to
serve as a vital voice in this debate. I would be happy to answer questions you
might have.
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