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CENTERS FOR DISEASE CONTROL AND PREVENTION
National Center for Injury Prevention and Control
State Strategies for Preventing Prescription Drug Overdoses Meeting
January 13-14, 2009
Atlanta, Georgia
Record of the Proceedings
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TABLE OF CONTENTS
Page
Report of the meeting.................................................................................................................. 3
Opening Session ................................................................................................................... 3
Scope of the Drug Poisoning Mortality Problem .................................................................... 5
Summary of the Conference on Legal Strategies .................................................................. 7
The Role of PMP Data in prescription drug overdose Prevention ........................................ 11
The Role of State Medical Examiner Data in prescription drug overdose Prevention........... 14
The Role of Epidemiologic Data in prescription drug overdose Prevention .......................... 17
Overview of the Patient Review and Coordination Program ................................................ 21
Overview of the Fentanyl Patch Patient Safety Program ..................................................... 25
Overview of the Washington State Opioid Dosing Guidelines .............................................. 29
Overview of Utah Clinical Guidelines on Prescribing Opioids .............................................. 33
Overview of the Consistent Care Program for Frequent ED Users ...................................... 36
Overview of the North Carolina Chronic Pain Initiative and Project Lazarus ........................ 39
Open Discussion ................................................................................................................. 43
Closing Session .................................................................................................................. 46
Attachment 1: List of Participants…………………………………………………………………….47
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CENTERS FOR DISEASE CONTROL AND PREVENTION
National Center for Injury Prevention and Control
STATE STRATEGIES FOR PREVENTING PRESCRIPTION DRUG OVERDOSES
January 13-14, 2009
Atlanta, Georgia
Report of the Meeting
The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention
and Control (NCIPC) convened a meeting entitled the “State Strategies for Preventing
Prescription Drug Overdoses.” The proceedings were held on January 13-14, 2009 at CDC’s
Chamblee Facility in Atlanta, Georgia. The list of participants is appended to the report as
Attachment 1.
Opening Session
Ms. Amy Harris, Associate Director for Policy at NCIPC, served as the facilitator of the
meeting. She welcomed the state partners to the meeting and explained that the two
overarching goals of the meeting would be to (1) identify state- and local-based approaches to
address prescription drug overdoses and (2) identify linkages and opportunities for collaboration
among stakeholders in this area.
Ms. Harris outlined the structure of the meeting. On day 1, an overview of the scope of the
problem would be presented and the role of data in identifying and preventing prescription drug
overdoses would be described. On day 2, various stakeholders would present their respective
efforts in addressing and reducing prescription drug overdoses. The state partners would be
given ample opportunity to provide CDC with advice and recommendations on this issue. The
state partners also would be asked to describe their next steps from an individual or
organizational level in advancing policies and strategies to address the problem of unintentional
prescription drug overdoses in local jurisdictions or nationally.
Ms. Harris pointed out that CDC developed and distributed a “Partnership Matrix” as a tool to
systematically capture comments and recommendations the state partners would make during
the meeting on collaborative efforts in prescription drug overdose prevention among various
organizations, stakeholders and sectors. The state partners were also given background
materials to guide their deliberations, such as definitions of key stakeholders that would play an
important role in this effort.
Ms. Harris concluded her opening remarks by asking the participants to be candid and open in
providing input to CDC during the meeting. She recognized the State and Territorial Injury
Prevention Directors Association (STIPDA) and the Home Safety Council (HSC) for providing
refreshments and other support for the meeting.
Dr. Ileana Arias, Director of NCIPC, joined Ms. Harris in welcoming the participants to the
meeting and providing CDC with their valuable time and expertise. She explained that NCIPC’s
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mission is to prevent injuries and violence, reduce their consequences, and assure all
Americans live their lives to their fullest potential. To fulfill its mission in the current era of
limited resources, NCIPC has been deliberate over the past three years in terms of focusing its
attention on issues that would have the most significant impact on public health.
NCIPC’s analysis of its programs and existing resources led to the determination that prioritizing
the prevention of residential fires, child maltreatment and falls in older adults would result in the
best health outcomes to the most populations. NCIPC’s rationale for prioritizing these public
health issues is summarized below.
Residential fires, child maltreatment and falls in older adults are associated with a high burden
of morbidity and mortality in the United States. Science-based interventions that have been
shown to be effective in reducing injuries in these three areas are now available for immediate
implementation. Moreover, partners and stakeholders have made commitments to provide
support and assistance to NCIPC in reducing injury rates associated with child maltreatment,
residential fires and falls in older adults.
Dr. Arias conveyed that although the prevention of residential fires, child maltreatment and falls
in older adults are NCIPC’s top three priorities, unintentional poisoning has emerged as a
significant threat to the health of Americans and is now the leading cause of death among
persons 35-54 years of age in the United States. Because this trend was unexpected and
surprising, NCIPC has no proven strategies or solutions to address this complex problem at this
time. However, NCIPC is still required to provide answers at national and state levels to
address this issue due to its role as the “nation’s injury center.”
Dr. Arias acknowledged that an effective response to the complex and difficult problem of
prescription drug overdoses would require public health, law enforcement, drug enforcement,
the medical profession and other sectors to bring their expertise and resources to bear. As an
initial step in this effort, NCIPC held the “Promising Legal Responses to the Epidemic of
Prescription Drug Overdoses in the United States” meeting in December 2008 with various
stakeholders to begin creating an overall context and identifying legal and policy interventions
that could be applied to address prescription drug overdoses. The conference proceedings,
presentations and papers would be distributed to NCIPC’s state partners in the near future for
wider dissemination at state, local or organization levels.
Dr. Arias pointed out that NCIPC is now convening this meeting on State Strategies for
Preventing Prescription Drug Overdoses to obtain external advice, guidance and expertise from
its state partners on appropriate actions to take at state, local and program levels. CDC has no
federal mandate to tackle this issue, but the agency must bring its leadership role to bear in
convening various organizations and sectors to facilitate collaborations in addressing this
significant public health issue.
Dr. Arias concluded her opening remarks by asking the state partners to be candid in providing
input on CDC’s existing capacity and limitations, important needs in the field, and necessary
actions and resources to advance the prevention of prescription drug overdoses.
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Scope of the Drug Poisoning Mortality Problem
DRUG POISONING MORTALITY: SCOPE OF THE PROBLEM
Dr. Margaret Warner is an Injury Epidemiologist in the Office of Analysis of CDC’s National
Center for Health Statistics (NCHS). She explained that data from the NCHS National Vital
Statistic System (NVSS) showed motor vehicle traffic accidents and firearms as the top two
leading causes of injury deaths from 1968-2003. However, poisoning became the second
leading cause of injury deaths beginning in 2004, increased by 66% from 1999-2005, and is
now the leading cause of death among persons 35-54 years of age.
CDC used various data sources to analyze and determine the scope of drug poisoning mortality
in persons 15-64 years of age from 1999-2005, including multiple causes of death files from
NVSS, death certificate data, and data collected on all resident deaths in the United States.
CDC performed the multiple cause of death analysis by classifying causes of death by ICD-10
code. The “underlying cause of death” was defined as a disease or injury initiating the chain of
events directly leading to death or the circumstances of an accident or violence producing a
fatal injury. The “contributing cause of death” was defined as significant conditions, including
specified drugs, that contributed to death.
Contributing causes included drugs, medicaments and biological substances and were found to
be among the leading causes in the unintentional and undetermined intent categories. For
purposes of the analysis, CDC grouped “other opioids,” “methadone” and “other synthetic
narcotics” as “opioid analgesics.”
NVSS data that mentioned drugs by mechanism and intent showed unintentional poisoning as
the leading cause of unintentional injury death among persons 35-54 years of age in 2005.
NVSS data showed that “other and unspecified drugs” were the most common in poisoning
deaths, but cocaine, oxycodone, hydrocodone and other opioids, and methadone were the
leading causes of deaths when drugs were mentioned. Benzodiazepines also were involved in
a significant number of deaths.
The proportion of unintentional/undetermined poisoning deaths in the 15-64 years age group
involving opioid analgesics increased from 24% in 1999 to 37% in 2005. However, the absolute
numbers of opioid analgesic deaths increased 185% from 3,300 to 9,500 deaths between 19992005. Of all opioid analgesic deaths in the 15-64 years age group in 2005, ~32% mentioned an
opioid analgesic, ~17% mentioned other unspecified drugs, ~15% mentioned either cocaine or
heroin, ~16% mentioned benzodiazepines, 3% mentioned both cocaine and heroin, and 17%
mentioned combinations with other drugs.
Persons 35-54 years of age accounted for the highest poisoning death rates in the other opioid,
methadone and other synthetic narcotics categories. From 1999-2005, age-specific poisoning
death rates that mentioned opioid analgesics were higher for persons 35-44 and 45-54 years of
age than for persons in younger or older age groups. The rates most rapidly rose in the
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youngest age group of 15-24 years and the oldest age group of 55-64 years. These rates were
found to be 2 to 4.5 times higher in 2005 compared to 1999.
By urbanization, the data analysis showed that poisoning death rates increased in all levels from
large central metropolitan areas to rural non-metropolitan areas. However, the most rapid
increases were seen in rural areas and the rates between levels of urbanicity were much more
similar in 2005 compared to 1999. Poisoning death rates widely varied among states and by
type of opioid analgesic.
By location, the data analysis showed that 65% of poisonings occurred in the home, 25%
occurred in unspecified places, and 4% occurred in trade or service areas, including hotels. Of
all poisoning deaths, 50% occurred in the home, 18% occurred in outpatient settings or
emergency departments (EDs), 9% occurred in inpatient settings, nursing homes or other
medical settings, and 4% were dead on arrival.
Overall, the data analysis showed that poisoning death rates are increasing and the majority of
these deaths involved drugs. By type of drug, the most rapid increases were seen in opioidrelated deaths with multiple drugs involved. By geographic location, rural areas accounted for
the fastest increase in poisoning deaths overall, but variations were seen in individual areas.
*****
The state partners made a number of comments and suggestions for CDC to consider in
refining its data analysis of drug poisoning mortality in the United States.
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CDC should be mindful that poisoning deaths in older persons are most likely
underrepresented in existing data sources. For example, older adults >65 years of age
are not adequately captured in NVSS, ED data, or data on substance abuse treatment
admission rates by age. Prescription drug overdose deaths in this age group might be
misdiagnosed and categorized as “natural causes” on death certificates. Maine and
other states do not perform autopsies on persons >50 years of age if their physicians are
able to confirm another cause of death.
CDC should include alcohol in the multiple cause of death analysis along with cocaine,
other opioids, methadone and benzodiazepines.
CDC should focus on geographic clusters of opioid analgesic deaths that are occurring
across the United States. Data should be analyzed by health services area because this
approach would allow data on opioid analgesic deaths to be collected across states and
might eliminate the problem with small data sets for deaths at the county level.
CDC should closely collaborate with the Substance Abuse and Mental Health Services
Administration (SAMHSA) in its efforts to develop prescription drug overdose prevention
strategies. SAMHSA maps survey data by both state and treatment service area.
SAMHSA data have shown higher rates of binge drinking and methamphetamine use in
rural areas. SAMHSA data by age showed spikes in mental health and substance use
issues among persons 18-24 years and prescription medication abuse among one in 10
seniors.
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Summary of the Conference on Legal Strategies
PROMISING LEGAL RESPONSES TO THE EPIDEMIC OF PRESCRIPTION DRUG
OVERDOSES IN THE UNITED STATES
Mr. Daniel Stier is an attorney in the CDC Public Health Law Program. He noted that CDC
convened a conference on December 2-3, 2008 to focus on promising legal responses to the
epidemic of prescription drug overdoses in the United States. The goals and objectives of the
conference were to (1) create a list of promising legal measures to prevent prescription drug
overdoses that could be shared with a broader audience; (2) discuss the strengths and
weaknesses of each of the promising practices identified; and (3) identify opportunities for
collaboration between public health, drug control authorities and other partners with an interest
in prescription drug overdose prevention.
The conference participants included local, state and federal representatives, public health,
Prescription Drug Monitoring Programs (PMPs) and other regulators, law enforcement and the
judiciary. An overview of PMPs was presented to guide discussions on promising strategies of
PMPs, operational and legal issues associated with interstate sharing of PMP data, and “doctor
shopping” statutes. The participants also discussed non-PMP strategies, such as state-issued
prescription forms, Maine’s Unused Drug Disposal Project, Louisiana’s Pain Management Clinic
legislation, drug courts, and Washington’s prescribing guidelines and subsequent litigation.
The PMP overview included a review of controlled substance schedules. Schedule I
substances have no recognized use in medical treatment. Schedules II-V substances have
legitimate medical uses. Schedule II substances have the highest potential for abuse, while
Schedule V substances have the lowest potential.
A presentation was made during the conference to describe the implementation of PMPs by
states from 1940-1988. California implemented the first PMP in 1940 and utilized the triplicate
prescription form to issue blank forms to practitioners to write prescriptions for what are now
Schedule II drugs. Law enforcement used these data to target patients, prescribers or
pharmacies that obtained, prescribed or dispensed drugs in unusual quantities and frequencies.
Electronic transmission of billing data from pharmacies to insurance companies via computers
was a part of routine practice by the early 1990s. Oklahoma developed and implemented the
first electronic PMP. The cost-effectiveness of electronic transmission of billing data provided
incentives through federal Harold Rogers grants for PMPs to convert and expand tracking of
controlled substances.
All 38 states that currently have PMPs electronically collect prescription data and most of these
states require submission of Schedules II-IV data. All operational PMPs electronically collect
the basic elements of prescriptions, such as the prescription number and date dispensed;
identity of the patient, prescriber and dispenser; and type of drug and quantity dispensed.
However, funding, staffing levels and stage of operational development of PMPs widely vary
among states. Most notably, Harold Rogers grant awards of $350,000 per year limit the
capacity of states to develop robust or comprehensive PMPs.
The most significant problem with interstate PMP data sharing is that no mechanism has been
developed to prevent a patient from filling a prescription in another city, neighboring state or a
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state across the border. A potential solution to interstate PMP data sharing is for pharmacists to
sign up with other PMPs in neighboring states, but this approach has been inefficient. A better
strategy is to develop a “hub and spoke” system that could facilitate efficient transmission of
PMP data among states. This system would eliminate the need to develop 49 separate data
exchange agreements. Although California and Nevada are currently piloting a hub-spoke
agreement, only Kentucky and Ohio have committed resources to this effort to date.
Legal issues associated with interstate PMP data sharing include the need to assess
confidentiality and privacy laws and regulations at federal and state levels. At the federal level,
the Health Insurance Portability and Accountability Act (HIPAA) privacy rule shields protected
health information held by physicians, pharmacists and other covered entities. Potentially
relevant exceptions or exemptions to the HIPAA privacy rule include fraud and abuse
prevention, controlled substance regulation, public health activities, law enforcement, treatment
purposes, and child abuse and other disclosures required by law.
At the state level, PMPs typically are required to (1) designate data as confidential and exempt
information from public records or open records laws; (2) delineate persons who are allowed
access, identify specific circumstances for access and describe lawful purposes for using
accessed data; and (3) comply with all relevant state and federal privacy and confidentiality
laws. However, the hub-spoke system involves additional complexities.
Some states have express authority for interstate data sharing laws. For example, the Kentucky
PMP can provide data to a certified or full-time peace officer of another state. Regardless of
state statutes, however, legal counsel should be consulted regarding the authority of states to
share data with other states.
A presentation was made during the conference on “doctor shopping” practices in which
patients obtain, attempt to obtain or fail to disclose the same or similar prescriptions from
multiple prescribers within an inappropriate time frame. Doctor shopping statutes state that
obtaining or attempting to obtain a controlled substance by deceit or fraud is unlawful. Laws in
13 states were amended to more specifically describe and prohibit doctor shopping.
Florida’s doctor shopping statute was highlighted during the conference as a model. This law
states that no person may withhold from a practitioner a request made to another practitioner
within the previous 30 days to receive a controlled substance or a prescription for a controlled
substance of like therapeutic use. Regardless of the historical motivation for passage of doctor
shopping statutes, however, consideration should be given to using these laws to identify
persons in need of assessment and referral for treatment.
A presentation was made during the conference on non-PMP strategies. Traditional stateissued prescription forms in multiple copies no longer exist. New York, California and Texas
supplement electronically transmitted data with paper serialized prescription forms. Actions
taken by these three states from 1940-2006 in advancing from triplicate prescription forms to
electronic transmission of Schedule II data were described during the conference.
On the one hand, advocates of paper-based systems maintain that paper trails have a
significant influence in reducing the availability of prescription drugs subject to abuse. On the
other hand, opponents counter that paper-based systems have a deleterious effect on patient
access to needed medications. A few studies have shown reductions in prescription medication
use with paper-based systems, but no published peer-reviewed papers have evaluated process
measures of paper-based prescription monitoring programs.
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Research should be conducted in the future to evaluate the efficacy of paper-based prescription
systems on medical use and access, abuse and diversion. These studies should be designed
to produce clinical and economic outcomes to fully evaluate the impact of paper-based
prescription systems on patients, drug abuse and diversion.
A presentation was made during the conference on the Maine Unused Drug Disposal Project.
Maine developed this program because unused medications are a source of diversion to drug
abusers. Based on conservative estimates, 4.3 million pounds of unused drugs are wasted
annually and present an environmental issue as well. U.S. Drug Enforcement Agency (DEA)
regulations prohibit non-registrant transfers. Moreover, pharmacy-based systems are not
feasible for unused drug disposal. However, Maine obtained Senate sponsorship and
endorsement from a variety of interested groups to pass legislation authorizing the “Maine
Mailback Program.”
The Maine program was funded with state dollars and a grant by the U.S. Environmental
Protection Agency. Operational elements of the program include prepaid mailers that are
available at pharmacies; the ability to directly mail unused drugs to the Maine DEA; waivers
granted by the U.S. Postal Service; codes to track the movement of mailers among the
pharmacy, user and Maine DEA; and appropriate destruction of medications by the Maine DEA.
The Maine program was piloted at 11 sites in four counties and found an envelope containing
>$7,000 worth of oxycodone. Of all participants in the pilot project, the average age was 70
years, 15% had no knowledge of the types of drugs they submitted, 83% were motivated by
environmental protection, and only 8% were motivated by patient safety. However, the Maine
pilot project did not sufficiently determine the adequacy of data. Moreover, comparable data
have not been collected from other states to date to verify the findings of the Maine pilot project.
Overall, Maine recognized the need to leverage additional resources and involve state offices to
assure compliance with the Mailback Program.
Legislation was passed in July 2005 for licensure of pain management clinics in Louisiana that
are owned and operated by physicians. The law was passed due to the large sale of
prescription drugs along the Louisiana-Texas border and the high rate of prescription drug
overdose deaths each year in both states.
Coroners have estimated that the legislation could contribute to a 50% reduction in prescription
drug overdose deaths in Calcasieu Parish, Louisiana in 2008 compared to previous years.
Violation of the statute carries a penalty of up to five years imprisonment and a fine of not more
than $50,000. Texas also plans to pass pain management clinic legislation due to the efforts of
its Cross-Border Task Force. Prescription drug overdose deaths increased in Jefferson County,
Texas from 5 in 2005 to 55 in 2006.
A presentation was made during the conference on drug courts. Judicially-supervised dockets
attempt to strike a balance between the need to protect community safety and improve public
health as well as the need to provide treatment and hold persons accountable for their individual
actions. This approach is an alternative to the traditional “revolving door” of the correctional
system. Miami created the first drug court in 1989, but 2,200 courts are now operating in all
states and territories. These drug courts serve 120,000 non-violent adults and juveniles each
year.
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A 2005 Government Accountability Office study and subsequent research showed that drug
courts were effective in reducing crimes, led to a cost-benefit ratio of $3.36 saved to every $1
spent, and resulted in annual cost-savings of $26,000 based on $10,000 to treat a drug court
patient versus $36,000 to house an inmate. During the conference, a judge reported extremely
positive prescription drug abuser results in the Eastern Kentucky Drug Court.
A presentation was made during the conference on a class action lawsuit that was filed in
federal court challenging prescribing guidelines published by the State of Washington. The
case is in the early procedural stage of development and involves numerous counts that allege
conspiracy, conflicts of federal labeling laws and other illegal acts. The Washington class action
lawsuit emphasizes the need to evaluate legal authorities regarding prescription drug abuse at
the outset of the process, develop an interagency plan and consult with external stakeholders.
In response to the class action lawsuit, the Washington State Department of Health recently
formed the Prescription Opiate Morbidity and Mortality Prevention Workgroup.
*****
The state partners made two key suggestions for CDC to consider in identifying additional
promising legal responses to the epidemic of prescription drug overdoses in the United States.
First, the “doctor shopping” definition should be revised to clarify the number of visits that would
fall in this category. Second, CDC should link its activities to ongoing efforts to develop a cost
recovery model of the hub-spoke system to facilitate efficient transmission of PMP data among
states. This model will serve as a resource for states to identify potential operational and other
costs associated with modifying existing data systems to exchange information through the hub.
Although the hub-spoke system will be based on a low fixed fee, variable costs will be
incorporated based on usage of the system. Rough estimates have shown that the fixed fee
would be ~$20,000 per year if all states participate in the hub-spoke system.
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The Role of PMP
Data
in Prescription
Drug Overdose
USE OF PRESCRIPTION
DRUG
MONITORING
PROGRAM
DATA Prevention
Mr. David Hopkins is the Program Manager of the Kentucky All Schedule Prescription
Electronic Reporting System (KASPER) in the Kentucky Cabinet for Health and Family Services
(KCHFS). He described the rationale for Kentucky developing a controlled substance abuse
program. Of all Kentuckians, 8.5% used prescription psychotherapeutic drugs for non-medical
reasons in the past year; 7% used Darvon, Percodan or other prescription pain relievers for
non-medical reasons in the past year; 4.6% used Valium, Xanax or other prescription
tranquilizers for non-medical reasons in the past year; and 2% used prescription stimulants for
non-medical reasons in the past year. Kentucky’s ranking in these four categories was either
first or fourth in the nation.
KASPER is Kentucky’s PMP and tracks Schedules II-V controlled substances prescriptions that
are dispensed within the state and reported by pharmacies and other dispensers. KASPER is
an electronic database that can be accessed on the Internet. KASPER is a tool to help address
the misuse, abuse and diversion of controlled pharmaceutical substances by providing a source
of information for healthcare professionals and serving as an investigative resource for law
enforcement. This problem is one of the largest threats to patient safety in the Commonwealth
of Kentucky. However, KASPER was not designed to prevent persons from obtaining
prescription drugs or decrease the number of doses dispensed.
KASPER was developed for $1.4 million. Drug Enforcement Branch staffing costs ~$223,000
each year, but this cost will decrease from >$1 million to ~$400,000-$500,000 after
implementation of eKASPER. Annual information technology support costs ~$1 million,
including hardware, software and staff development. The federal Hal Rodgers Grant provides
$400,000 per year for promotion, training and data analysis of KASPER.
Schedule 1 controlled substances include heroin, cocaine, marijuana and other drugs that
cannot be legally prescribed. Schedule II controlled substances are the most addictive legal
drugs, have the highest potential for abuse, and include OxyContin, Percocet, Ritalin and Tylox.
Schedule III controlled substances have less potential for abuse than Schedule I or II drugs and
include Lortab, Vicodin and other hydrocodone combinations.
Schedule IV controlled
substances have less potential for abuse than Schedule II drugs and include Xanax, Valium and
other benzodiazepines. Schedule V controlled substances have the least potential for abuse
and include codeine-containing cough mixtures.
At this time, ~10 million controlled substance prescriptions are reported to KASPER each year.
Dispensers are required to report prescription data to KASPER within eight days, but efforts are
underway to enter ~80% of data into the system within one day of dispensing through
RelayHealth processes. KASPER reports are only available at the request of authorized
individuals and can be sent via facsimile in 2-8 hours or through the Internet in 15 seconds.
KASPER reports are available 24 hours per day/7 days per week on any computer with Internet
access. The KASPER web site can be accessed at www.chfs.ky.gov/kasper.
KASPER stakeholders include a variety of groups. State licensing boards investigate potentially
inappropriate prescribing by licensees only. Practitioners and pharmacists review the controlled
substance prescription history of current patients to determine pharmaceutical or medical
treatment. Law enforcement officers review the controlled substance prescription history of
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individuals as part of an open bona fide drug investigation that must be certified by both an
investigator and supervisor.
The state Medicaid program screens recipients for potential abuse of pharmacy benefits,
determines “lock-ins,” and screens providers for adherence to prescribing guidelines for
Medicaid patients only. Judges and probation or parole officers review controlled substance
data to assure adherence to drug diversion or probation program guidelines.
KASPER reports show all controlled substance prescriptions an individual has had for a
specified period of time as well as the practitioner who prescribed and the dispenser who
dispensed the drugs. Based on 2008 data, prescribers accounted for 94.1% of KASPER users,
pharmacists accounted for 3.1% of users, law enforcement accounted for 2.7% of users, and
judges and other groups accounted for 0.1% of users. Of all users, 28.6% of prescribers have
KASPER accounts, 21% of pharmacists have accounts, and 14.7% of law enforcement
agencies have accounts.
The following KASPER data elements are available for study: the unique identifier, date of birth,
gender and address of the patient; the name, quantity, strength, therapeutic category, number
of supply days and date dispensed of the drug; and the name and city of both the prescriber and
dispenser. The number of records maintained in KASPER increased from ~8.3 million with 2.04
prescriptions per person in 2001 to ~10.2 million records with 2.41 prescriptions per person in
2008.
In 2008, hydrocodone accounted for 43% of controlled substances prescribed in the state of
Kentucky followed by alprazolam at 15% and oxycodone at 12%. The number of persons who
received a controlled substance from >5 different prescribers and >5 different dispensers was
5,112 in 2007 and 2,825 in the first six months of 2008. The number of persons who received a
controlled substance from >10 different prescribers and >10 different dispensers was 342 in
2007 and 200 in the first six months of 2008. The number of persons who received a controlled
substance from >15 different prescribers and >15 different dispensers was 111 in 2007 and 64
in the first six months of 2008.
The Kentucky Injury Prevention and Research Center conducted a study in 2005 using 20002002 KASPER data to summarize demographic and geographic tends in prescriptions and the
leading causes of death and hospitalization due to injuries and also to identify geographic
associations between the volume of prescriptions filled and the incidence of injury.
The study showed that narcotic analgesics and benzodiazepines were the leading drugs
mentioned on hospital discharges for prescription drug overdoses. The study emphasized the
need to consider benzodiazepines as a high priority in terms of adverse effects on health and
safety based on their role in intentional and unintentional prescription drug overdoses, motor
vehicle accidents and falls in elderly persons. However, more extensive research is needed
because the preliminary investigations of correlations between narcotic analgesics and
benzodiazepines and injuries in Kentucky were largely inconclusive.
KASPER legislation requires KCHFS to develop trend reporting criteria and publish a quarterly
trend report. KCHFS developed criteria to meet this statute in collaboration with licensure
boards and a law enforcement focus group. KCHFS utilized geographic information system
(GIS) software to obtain a graphical representation of the data. Maps were created to illustrate
usage of all controlled substances, hydrocodone, Xanax, methadone and oxycodone in 20052007 based on three-digit zip code areas in Kentucky.
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Overall, the challenges to KASPER include state statutes and regulations that restrict allowable
access to data for research purposes; decreased staffing due to limited availability of technical
and epidemiology support resources and lack of funding; de-identified data sets based on
HIPAA regulations; and minimal capacity to determine health and public safety actions based on
data.
*****
The state partners made a number of comments and suggestions to strengthen the role of PMP
data in prescription drug overdose prevention.
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CDC should consider KASPER as a model in collecting prescription drug overdose data.
KASPER breaks down prescription drug misuse, abuse and diversion in separate age
groups of 65-74 years, 75-84 years, and >85 years instead of combining all persons >65
years of age in one category. KASPER can be used as a solid public education tool
because different messages on prescription drug overdoses need to be developed for
specific age groups.
CDC should provide national leadership in encouraging physicians to report PMP data to
states. Many providers believe this effort is a waste of time because PMP data systems
are not in real time. Most notably, the delay between reporting and making PMP data
available can be up to 30 days in some states. CDC also should develop and distribute
guidelines and detailed instructions for providers to appropriately use PMP data.
CDC should conduct a qualitative study with providers in states throughout the country
who use PMP data to determine their experiences in utilizing these systems. Maine’s
ongoing study of usage and non-usage of PMP data systems in all categories of
licensees should be included in this effort.
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The Role of State Medical Examiner Data in Prescription Drug Overdose Prevention
THE ROLE OF STATE MEDICAL EXAMINER DATA IN THE PRESCRIPTION DRUG
PROBLEM: AFFECTING POLICY
Dr. Marcella Sorg is the Director of the Rural Drug and Alcohol Research Program at the
University of Maine. She explained that her role as a forensic and medical anthropologist is to
serve as a producer and consumer of drug-related data. Medical examiners (MEs) who perform
forensic death investigations provide a link between public health and public safety. The
purpose of a death investigation is to determine the cause and manner of violent, suspicious
and “unattended” deaths.
Because death investigations are under the jurisdiction of state or local rather than federal
agencies, these investigations significantly vary among and within states based on coronerversus-ME systems; local laws, cultures and practices; and funding or resource levels. With the
exception of vital records, statute-based obligations for MEs to produce data often do not exist.
MEs and coroners have dual roles in public health and public safety and can be housed in
health departments, attorney general offices, public safety departments or independently. Over
3,000 MEs or coroner jurisdictions exist and their duties are regulated by statute, rule-making or
customs.
MEs are hired or appointed, but board certification in pathology or forensic pathology and other
requirements differ. Coroners are elected, primarily at the county or district level, and most are
non-physicians. Resources for MEs and coroners are appropriated as public policy and paid for
by tax dollars. As a result, resources are limited and variable. Funding for staff and services is
needed in drug death investigations because MEs and coroners typically do not determine
transportation, autopsy and toxicology needs and frequently outsource toxicology. Nonphysician coroners outsource autopsies as well.
Drug death investigations and the level of training for local MEs, non-physician death
investigators, coroners and police during scene investigations vary. For example, not all drug
death investigations identify the individual who will obtain toxicology samples; determine
whether an autopsy will be performed; focus on the potential involvement of criminals; or
confirm the location of the death, such as the residence, hospital or outdoors.
Dose is a key component to forensic toxicity, but this element is usually unknown. The
interpretation of toxicology results depends on persistence of the drug in the body, drug
combinations and chemical detection. Forensic toxicology is 90% accurate, presumptive and
typically requires screening and quantitative tests. Changes occur postmortem and with
decomposition, such as the change from heroin to morphine. Although other sources are used,
the peripheral blood test is best. Individual tolerances are an issue and are particularly critical
for opiate or opioid deaths. Medical data should be collected from the heart, liver and lung to
determine disease in these organs.
Data are extremely difficult to obtain on the source from which the decedent obtained drugs,
whether the drugs were prescribed, and the form in which the drugs were ingested. Most
notably, scenes are cleaned prior to the death investigation; requests for medical and
prescription records consume resources; and the degree to which PMPs have access to ME
14
records and include data from methadone clinics is unknown. The cause of death is the
mechanism or medical reason an individual died and can include up to four links in a causal
chain. The cause of death also might note other significant conditions that contributed to death.
The cause of death can be recorded as a homicide, suicide, accident, undetermined death, or a
natural death, including therapeutic drugs at therapeutic levels.
From an ME’s perspective, prescription drug deaths are complicated cases and require more
time to investigate than other types of deaths. These investigations also are frustrating due to
interpretive issues with toxicity from multiple drugs. Prescription drug deaths are a source of a
large increase in workloads of MEs and often are not supported with additional resources in
most jurisdictions. From an epidemiologist’s perspective, “poly-drugs” are difficult to specify, but
efforts are underway to train epidemiologists to identify each individual drug involved in a death.
MEs and coroners are pressured to provide timely statistical data. These data affect decisions
by policymakers in terms of drug treatment methods and funding, the focus and funding of law
enforcement, and approaches for prescribers to prescribe drugs. MEs and coroners also are
pressured to provide data that might not exist, such as the source from which the decedent
obtained drugs, the presence or absence of a prescription for the drug, and the form in which
the drug was ingested. Guidelines need to be developed that include toxicology screening
parameters, date of decomposition, presence of co-intoxicants and other factors.
Of all states, <50% have drug death data. These data are not comparable among states and
might not focus on the problem of prescription drug deaths. Moreover, ME data generally are
not proactively disseminated to other groups. In one state model, Maine created its Chief
Medical Examiner System in 1968, but the workforce only includes two staff for the entire state
population of 1.3 million persons. In overdose deaths in Maine, the ME typically does not visit
the scene, performs autopsies on ~78% of decedents, and conducts a full toxicology screen and
histology if indicated.
The goals of an autopsy in an overdose death are to determine or rule out natural disease or
trauma that might have caused the death and collect samples for toxicology and histology. Data
collected from the Maine Office of the Chief Medical Examiner (OCME) showed that prescription
drugs accounted for the majority of drug deaths and have increased the complexity of cases.
OCME data also documented a 429% increase in drug deaths from 1997-2006. Opiate
addiction, treatment episodes and demand for methadone treatment increased in Maine in
2001. To address this problem, the Maine Office of Substance Abuse formed a task force and
OCME leveraged funding to conduct a study on drug-related deaths from 1997-2002.
The study showed that prescription drugs accounted for 92% of drug deaths in Maine. The
study and a subsequent press conference in 2002 led to a number of changes in the state. The
occurrence of “take-home” methadone was reduced and OxyContin was removed from the
preferred Medicaid drug list. The Maine PMP was developed and implemented in 2004.
Department of Justice (DOJ) grants were awarded in 2003-2007 to continue monitoring of drug
death data. Federal dollars were allocated to form the Maine Community Epidemiology
Surveillance Network.
A statewide prevention grant was awarded for county groups to collect county-specific data.
Workshops were convened and policy briefings were held to educate legislators in Maine about
the problem of drug deaths from prescription drugs. The Maine Medical Association included
drug death data in training sessions throughout the state to educate providers on appropriately
writing opiate prescriptions.
15
Maine acknowledges a number of problems in using ME data to affect policy. The exclusion of
methadone clinic data from the Maine PMP is a significant issue. Data from these clinics are a
critical need and should be required under the concept of a “medical prescription home”
because methadone accounts for ~33% of drug deaths in the state. Providers have limited
knowledge on utilizing drug death data to respond to prescription drug diversion and misuse in
their patient populations. The need for the state Medicaid agency to use PMP data has not yet
been determined. Federal feedback loops are needed to resolve variations and discrepancies
in data.
Overall, the fiscal impact of drug deaths on ME/coroner systems is significant. Funding for
processing and disseminating drug death data is frequently from federal sources and sporadic.
Because methadone is a significant part of the drug death problem, more attention should be
given to coordinating data from methadone clinics, Medicaid databases and PMPs. Statespecific systems should be developed to identify solutions. Access to PMP data should be
provided to MEs and coroners. Maine will change its laws over the next two years to support
this effort. Requests for duplicative surveillance data should be avoided; unfunded mandates
should not be created; and epidemiologists should take caution in comparing raw data across
variable ME/coroner jurisdictions.
*****
The state partners made a number of comments and suggestions to strengthen the role of ME/
coroner data in prescription drug overdose prevention.
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Efforts should be made to review clinical data from hospital records to identify blood
gases and other outcomes that could be used to make a more clear diagnosis of
respiratory arrests and other contributing factors to prescription drug deaths.
MEs should be trained to use PMP data with each decedent to determine if drugs based
on toxicology screening were from legitimate prescriptions.
Model statutes, provisions or language to provide MEs with access to PMP data should
be developed and disseminated to states that are considering establishing or revising
PMP programs. MEs should be used as strong supporters and advocates for the
development and improvement of PMPs in states because PMP data can be extremely
helpful to MEs and coroners.
Guidelines should be developed with toxicology screening parameters, date of
decomposition, presence of co-intoxicants and other factors to assist MEs in performing
drug death investigations.
ME and coroner data should be provided to PMPs to assist in identifying specific types
of drugs involved in prescription drug deaths. PMPs should use ME data to focus on
diversion of prescription drugs among patients.
16
The Role of Epidemiologic Data in Prescription Drug Overdose Prevention
THE ROLE OF SUBSTANCE USE EPIDEMIOLOGY, NEW MEXICO DEPARTMENT OF
HEALTH
Ms. Nina Shaw is a Substance Abuse Epidemiologist in the New Mexico Department of Health
(NMDH). She explained that the NMDH Substance Abuse Epidemiology Section was formed in
1991 with three staff initially to evaluate substance abuse treatment. NMDH received three
Center for Substance Abuse Treatment State Needs Assessment Program grants from 19932005 with funding of $200,000-$300,000 per year for nine years. This funding allowed NMDH to
increase its workforce to five staff. State alcohol excise tax dollars for DWI programs supported
screening and tracking of DWI offenders in 1997. Lack of funding in 2000 led to a decrease in
staff, but CDC has allocated funding since 2002 to support an alcohol epidemiologist position.
The NMDH Injury and Behavioral Epidemiology Bureau conducts surveillance of substance use,
fatal and non-fatal injuries, and a wide variety of other health conditions and related behaviors in
the state population. The Survey, Injury Prevention, and Substance Abuse Sections conduct
these activities within the Bureau.
The Substance Abuse Epidemiology Section describes and monitors the burden of substance
use and mental health conditions in the state and provides policy recommendations as
appropriate. Other activities within the Section include surveillance, analysis and dissemination
of data on substance use behaviors, mental health conditions, overdose deaths and other drugand alcohol-related mortality; special studies; and prevention activities, policy development,
advocacy and epidemiology consultation. The Section includes four epidemiologists and one
fellow to conduct these activities.
Surveillance, data analysis and dissemination activities are designed to develop, analyze and
interpret data related to substance use and mental health; respond to data requests; create
indicators for the Information Based Indicator System; assess the usefulness of data sets and
collection processes; link data sources to produce analysis-ready data sets; and collaborate
with stakeholders, strategic workgroups and entities at state, federal and community levels.
Prevention activities, advocacy, policy development and epidemiology consultation support the
State Prevention Framework State Incentive Grant; assist in evaluation of prevention and
intervention initiatives; evaluate NMDH performance measures; conduct legislative bill analyses
related to substance use and mental health; and support the Interagency Behavioral Health
Collaborative and associated workgroups and task forces.
NMDH’s three-year pilot project, special studies and manuscripts have focused on overdose
surveillance in two hospital EDs; the prevalence of alcohol dependence among excessive
drinkers; types of alcoholic beverages consumed by high school aged youth; New Mexicospecific alcohol attributable fractions; and depression among adults. NMDH used ME data to
analyze drug overdose deaths in the context of methadone, prescription drug death trends,
changes in drug combinations causing death over time, urbanization levels, different trends
between U.S.-Mexico border and non-border counties, and PMP linkages.
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NMDH uses its Strategic Prevention Framework State Incentive Grant to assist the Office of
Substance Abuse Prevention; provide consultation and technical assistance to all sub-grantees;
participate on the State Epidemiology Workgroup; and generate the state epidemiology profile
for use by evaluators, sub-grantees and other stakeholders.
NMDH’s Behavioral Health Services Division provides estimates and demographic data to meet
substance abuse treatment needs for the state and planning regions; delivers assignments for
the SAMHSA Substance Abuse, Prevention and Treatment Block Grant; and provides technical
assistance and epidemiologic consultation for the examination of estimates of treatment needs
by other drug use indicators, data quality improvement, data collection processes and the State
Methadone Authority. NMDH is planning a future activity to provide estimates to meet mental
health treatment needs for the state and regions.
NMDH assists local DWI programs to develop and evaluate data from local grant programs;
develop and implement a quality control process; provide professional evaluation guidance;
generate an annual recidivism report; and provide links to administrative databases. NMDH
collaborates its activities with a number of partners at local, state and federal levels.
NMDH’s substance use epidemiologic data have played an important role in informing policy in
New Mexico. The 1997 Harm Reduction Act established the state-funded Harm Reduction
Program to facilitate syringe exchange. Legislation was passed in 2001 to expand naloxone
availability to all heroin users, family members and friends. Drug overdose was added to the list
of administrative codes as a notifiable and reportable condition in 2003. The Alcohol
Advertising and Youth Task Force was established in 2007.
During the 2009 legislative session, discussions will be held on the development of a Medication
Assisted Treatment Task Force to increase the accessibility and availability of medicationassisted treatment to underserved populations; creation of the Drug Policy Task Force to
examine current drug policies in New Mexico; treatment rather than incarceration for non-violent
drug offenders; and a local option tax on alcohol that could be used for prevention efforts.
The 911 Good Samaritan Law was passed in 2007 in New Mexico to provide limited immunity
from drug possession charges when a drug-related overdose victim or witness to an overdose
seeks medical assistance. The law helps to eliminate the fear of calling 911 for help during an
overdose and protects witnesses from any potential police involvement or reprimand due to
drug possession at the scene of an overdose. However, the law does not protect persons from
prosecution for other offenses and outstanding warrants and also does not interfere with law
enforcement protocols to secure the scene of an overdose.
NMDH utilizes a variety of drug indicator surveillance data sources, including the Office of the
Medical Investigator, vital records, law enforcement, PMP, HIV and Hepatitis Epidemiology
Program, Harm Reduction Program, treatment episode data set, hospitalization inpatient
discharge data, Youth Risk and Resiliency Survey, and the National Survey of Drug Use and
Health. In the future, NMDH plans to use data from emergency medical services, poison control
centers, Medicaid, drug courts, and CDC’s Behavioral Risk Factor Surveillance System.
NMDH has used these sources to collect data on drug-induced death rates in New Mexico and
the United States from 1990-2006; unintentional opioid poisoning death rates by schedule in
New Mexico from 1990-2007; unintentional prescription drug death rates by demographics in
New Mexico non-border and border counties from 2003-2007; hospital discharges by primary
drug-related diagnosis in New Mexico from 2003-2007; primary substances of abuse at
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treatment admission in New Mexico in 2007; non-medical use of pain relievers in the past year;
current drug use by students in grades 9-12 by gender in 2007 in New Mexico; and the mode of
exposure among HIV/AIDS cases in New Mexico in 2008.
NMDH also used data from multiple sources to publish numerous reports and manuscripts on
drug abuse patterns and trends in New Mexico; DWI offender characteristics and recidivism
rates; unintentional methadone-related overdose deaths in New Mexico; changing trends in
drug overdose deaths; social indicators; and the New Mexico epidemiology profile.
*****
The state partners made a number of comments and suggestions to strengthen the role of
epidemiologic data in prescription drug overdose prevention.
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Linkages should be made to ongoing efforts from CDC’s December 2008 Conference on
Legal Strategies to address legal issues associated with the exchange of epidemiologic
data along the U.S.-Mexico border.
Cross-agency collaboration with agencies that purchase or regulate health care in states
and collaboration between agencies and providers in states should be strengthened.
These state agencies include health departments, Medicaid agencies, employee benefit
agencies and workers’ compensation agencies. The organized medical community has
raised serious concerns about prescription drug overdose deaths and expressed a
strong interest in becoming involved in addressing this problem.
Efforts should be made to take advantage of the desire of the Federation of State
Medical Boards (FSMB) to form partnerships to address prescription drug overdose
deaths. FSMB recently developed and distributed a model guideline to physicians
across the country, but the document is sponsored by large pharmaceutical companies
and does not mention dosing.
Schools, hospitals, social service agencies and non-governmental organizations (NGOs)
should be engaged as key partners in the prescription drug overdose prevention
initiative. These groups have networks and other resources beyond state agencies and
will play a critical role in education, outreach and development of targeted messages to
specific audiences.
The prescription drug overdose prevention initiative should be designed as a crosscutting and collaborative effort with involvement across sectors, such as superintendents
of public instruction, state patrol agencies, attorney general offices and local health
officers. The Washington State Department of Health should be reviewed as a model in
convening groups across multiple sectors.
Collaborations should be developed with state health departments that license state
methadone clinics. In New Hampshire, for example, this group has been extremely
effective in partnering with the ME and poison control center to provide education and
raise awareness of prescription drug overdoses.
Prescription drug overdose prevention messages should be tested and shown to be
effective prior to dissemination. For example, substance abuse treatment centers in
Washington State have raised concerns that educational messages might be viewed as
instructions on “how to get high.”
CDC, STIPDA and the Council of State and Territorial Epidemiologists (CSTE) should
collaborate in performing surveillance of prescription drug overdoses and using these
data to establish national prescription drug overdose prevention standards.
Universities should be extensively engaged in all policy discussions and guideline
development for the prescription drug overdose prevention initiative. For example,
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Washington State has created strong relationships with academicians who conduct pain
research.
The Massachusetts Department of Public Health should be reviewed as a model to
provide training on prescription drug overdose prevention to multiple state groups,
including substance abuse treatment centers, HIV/AIDS providers, correctional settings
and homeless service providers. These groups have been extremely receptive in
Massachusetts to including prescription drug overdose prevention messages in existing
activities. Massachusetts is launching this important strategy statewide and has
collected evidence to demonstrate the efficacy of this approach in reducing prescription
drug overdoses.
20
Overview of the Patient Review and Coordination (PRC) Program
Patient Review and Coordination Program For Medical Assistance Clients Who Need
Assistance In Appropriate Use of Services
Ms. Phyllis Coolen is a Clinical Nurse Advisor and Physical Rehabilitation Center Manager in
the Washington State Department of Social and Health Services (DSHS). She gave a Medicaid
perspective on state strategies for preventing prescription drug overdoses. National and
statewide data indicate an increase in the number of deaths due to opiates. The use of
prescription opiates also has increased in the Medicaid population because clients with minor
medical diagnoses and high-risk medical conditions receive large amounts of narcotics.
Moreover, the correlation between “ED cycling” and narcotics allows patients to easily obtain
narcotics through the ED. These complex issues require multiple solutions and partnerships.
Aged, blind or disabled Medicaid clients are frequent ED visitors, have high rates of cooccurring mental illness and alcohol or drug disorders, and receive large volumes of prescription
opiates. Relatively few Medicaid clients receive drug or alcohol treatment services, but many
receive mental health services. The average number of pain prescriptions is highest among
Medicaid clients who most frequently visit the ED.
Washington State developed the PRC Program as a health and safety program for Medicaid
fee-for-service, managed care, and state-funded clients who overuse or inappropriately use
medical services. The PRC Program is a federal requirement of all Medicaid programs. The
objectives of the PRC Program are to decrease and control over-utilization and inappropriate
use of health care; minimize medically unnecessary and addictive drug use; provide patient
education and coordination of care; assist providers to manage clients with education and
resource referrals; facilitate coordination of care; and reduce expenditures on unnecessary and
inappropriate services.
Internal and external direct referrals and monthly algorithms are the two approaches DSHS
uses to identify Medicaid clients for PRC review. The majority of external referrals are from
pharmacies, but referrals also can be made on the PRC web site. Algorithms are run to identify
high numbers of narcotic users, prescribers for narcotics, and ED users with non-emergent
diagnoses.
PRC review and placement must be medically necessary. These criteria include any of the
following two occurrences within a 90-day period: services from >4 different providers,
prescriptions filled by >4 different pharmacies, >10 prescriptions, prescriptions written by >4
different prescribers, receipt of similar services from >2 providers in the same day, or >10 office
visits.
Additional criteria for PRC review and placement include any single occurrence within a 90-day
period of: >2 ER visits; a medical history of “at risk” behavior; repeated and documented efforts
to seek medically unnecessary services; counseling at least once by a healthcare provider or
department about appropriate use of healthcare services; receipt of controlled substances from
two different prescribers in one month; a history of duplicative, excessive or contraindicated
healthcare services; or receipt of healthcare services that are not within acceptable medical
practice.
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For purposes of PRC review and placement, “at risk” is defined as forging or altering
prescriptions, paying cash for controlled substances, using another client’s medical assistance
identification card without authorization, or frequently seeking medically unnecessary services.
Patients who are placed in the PRC Program are initially restricted for 24 months to certain
providers, such as one primary care provider, one pharmacy, one narcotic prescriber and one
hospital for non-emergency services. The system contains edits to deny claims from
unassigned providers. The PRC restriction takes precedence over all edits in the pharmacy
point of sale system.
DSHS data collected as of May 2008 showed that the top 10 diagnoses for the top 200 PRC
clients were headaches or migraines; abdominal pain; lumbago or back pain, sprain or strain;
chest pain; pain, sprain or strain in limbs; cervicalgia or neck pain, sprain or strain; dental
disorder; other chronic pain; depressive disorder; and an anxiety state. The morphine
equivalent dose (MED) was included in the PRC Program to determine the total quantity of a
drug currently taken by patients. A scheduled-medication detailed report with the total MED per
day for each patient is shared with prescribers.
DSHS expanded the PRC Program in 2005 with additional full-time staff and significant process
improvement activities, including database systems and automated processes. The current
PRC caseload of >3,060 cases is managed by three clinical nurse advisors, seven program
managers for daily care management, and two support staff.
DSHS’s cost analysis showed that the PRC Program resulted in savings of >$43.9 million since
FY’06 or >$1.5 million per month, a 33% decrease in ED visits, a 37% decrease in physician
visits, and a 24% decrease in the number of prescriptions. Of 1,364 PRC clients who
completed their two-year restriction in 2007-2008, 50% were released based on compliance,
28% were retained due to continued high ED use, 15% are no longer eligible for medical
assistance, and 6% are currently under review.
Of 518 PRC clients who were referred for narcotic abuse in 2006, the average number of
narcotics prescriptions decreased from 3.07 to 1.63; the average number of prescribers
decreased from 4.8 to 2.8; the total MED decreased from 312 MED/day to 185 MED/day; and
the total number of narcotic claims decreased from 2,274 to 839.
In January 2008, seven managed care plans that contract with DSHS were required to develop
PRC Programs. Each plan identified restrictions for specific provider types and will restrict
clients to a managed care plan for 12 months. Preliminary data showed that in the first four
months, one plan with 42 patients achieved a 31% reduction in direct and indirect monthly costs
and another plan with 158 patients achieved pharmacy and ED utilization savings of $47,222.
The Pacific states of Washington, Oregon, California, Hawaii and Arkansas ranked the highest
in life use and non-medical use of pain relievers. Poisoning was the leading cause of
unintentional injury death in Washington State in 2006. Over 90% of poisonings were due to
drug overdoses. Deaths have continued to rise from 24 deaths in 1995 to 638 deaths in 2006.
Medicaid clients accounted for nearly 50% of prescription opioid deaths in Washington State.
Of these clients, 60% died at home. The highest age group in prescription opioid deaths for
both males and females was 40-59 years, but 15 children 15-19 years of age died as well.
Lumbago, back pain, sprain or strain; pain, sprain or strain in limbs; and abdominal pain were
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the top three medical diagnoses in the year prior to prescription opioid deaths among Medicaid
clients in Washington State.
DSHS reviewed the average MED/day per client in its analysis of prescription opioid deaths
involving Medicaid clients in Washington State as well as a series of behavioral profiles. The
alcohol and drug profile showed that 21% of 154 Medicaid clients had an at-risk diagnosis. Of
these clients, 70% had a diagnosis of drug poisoning, 53% had an event that indicated the need
for alcohol or drug treatment, 5% received a drug or alcohol assessment 12 months prior to
death, and 22% received alcohol or drug treatment 12 months prior to death.
The mental health profile showed that 39% of Medicaid clients received mental health services
in the 12 months prior to death. Depression was the number one mental health diagnosis
among 26% of clients, while antidepressants and anticonvulsants were the top two medications
used by 53% and 39% of clients, respectively. The top therapeutic classes of drugs involved in
prescription opioid deaths within the Medicaid population were analgesics or narcotics,
anticonvulsants, selective serotonin reuptake inhibitors, anti-anxiety drugs, muscle relaxants,
gastric acid secretion reducers, non-steroidal anti-inflammatory drugs, beta-adrenergic agents,
anti-psychotic or atypical drugs, and penicillin.
The children’s profile showed that each child who was placed in the PRC Program was from a
dysfunctional family unit. Of these children, 93% were from a single parent household, 20%
were in several different foster homes, 47% were raised by a relative other than the parent, 27%
were homeless at some point in their lives, 67% had a parent or sibling with a history of mental
disorder, substance abuse, domestic violence or criminal activity, 100% of children had a mental
health disorder ranging from depression to high anxiety, 40% received 1-3 different mental
health drugs with two children receiving significantly higher dosages than recommended, 73%
had substance abuse issues with two children 11 years of age applying for assistance for
substance abuse treatment, and 60% had co-occurring diagnoses.
Overall, Medicaid clients who inappropriately use healthcare services and have high ED visits
and high narcotic use are the same or similar group that is dying from prescription opioids.
DSHS uses the PRC Program as only one tool to focus on the health and safety of clients and
decrease inappropriate use of healthcare services. DSHS recognizes that these complex
issues will require more than one solution and public-private partnerships across sectors.
*****
The state partners made a number of comments and suggestions to strengthen linkages and
collaboration among Medicaid, private insurers and other stakeholders in developing
prescription drug overdose prevention strategies.
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Medicaid should place more emphasis on the extent to which EDs dispense samples of
narcotics to patients. Hospitals typically do not maintain an inventory of samples that
are distributed to patients and are not required to report sample narcotics to PMPs.
Prescription drug abuse and diversion might be underreported in the Medicaid
population due to sample narcotics that are dispensed to patients during high numbers
of ED visits.
Washington State should be reviewed as a model in establishing public-private
partnerships across sectors to address the problem of prescription drug overdoses in the
Medicaid population. Washington State convened multiple groups in this effort, including
various state agencies; a group of medical directors representing the Department of
Veterans Affairs, Department of Corrections, Department of Health and DSHS; the
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Medical Quality Assurance Commission along with dental and osteopathic medical
boards; ED physicians; academic researchers; and local health directors.
Efforts should be made to either allow social workers, nurses and other medical entities
to access PMP data or utilize and take advantage of PMP data. In Kentucky, for
example, state statutes did not permit social workers to access PMP data. However, the
state granted an exception for KCHFS to provide social workers with PMP data that
could be used to support an open investigation of a child or elderly person who was
suspected of being in danger in the home due to drugs.
Utah should be reviewed as a model in exchanging data between different state
agencies. Utah is currently attempting to overcome statutory issues and obtain
permission from the state Medicaid agency and health department to link Medicaid and
PMP controlled substances databases. This strategy would allow Utah to collect more
information on risk factors of persons who die from prescription drug overdoses.
Strong collaborations should be formed with insurers due to their ability to identify and
refer “suspected” prescriber abusers to medical and provider licensure boards or law
enforcement if necessary.
State health departments should identify Medicaid patients who died from prescription
drug overdoses and then collaborate with state Medicaid agencies to link these
decedents to PRC Programs in an effort to improve overall data quality.
Washington State should be reviewed as a model in facilitating statewide data sharing
among multiple agencies. The workers’ compensation and Medicaid agencies in
Washington State collect death certificate data from the health department to review
prescription drug overdose death patterns in their respective patient populations. The
health department also reviews statewide data on prescription drug overdose deaths.
DSHS should be reviewed as a model in performing a cost-benefit analysis to
demonstrate the cost-savings and utilization outcomes of the PRC Program in
Washington State. Legislative champions at the level of the state Secretary, Assistant
Secretary or Executive Team should be identified to undertake this effort on a larger
scale. Collaborations should be established with private insurers and other stakeholders
to provide cost-savings information to high-level state legislators.
Maine should be reviewed as a model in incorporating specific language into providers’
contracts with Medicaid and other insurers. According to contractual language,
providers in Maine must access the state PMP each quarter to identify each patient with
long-term opioid use. The contractual language has changed behaviors and served as
an incentive for providers in Maine to utilize the state PMP.
24
Overview of the Fentanyl Patch Patient Safety Program
AN EVALUATION OF THE DOD TRANSDERMAL FENTANYL PHARMACY EDIT
LTC Stacia Spridgen is the Director of the Department of Defense (DoD) Pharmacoeconomics
Center. She gave an insurer perspective on state strategies for preventing prescription drug
overdoses. The DoD Pharmacoeconomics Center is responsible for conducting clinical and
cost-effective drug reviews and incorporating this information into the Uniformed Formulary to
meet the needs of military beneficiaries.
The Uniformed Formulary provides free points of pharmacy services within DoD for all services,
including military treatment pharmacies, ~54,000 network pharmacies and the TRICARE mail
order pharmacy. The Patient Outcomes Research Team is closing the gap on formulary
decisions by conducting patient outcomes research to better assess DoD’s formulary decisions
and improve the impact on beneficiaries.
Of DoD’s current TRICARE population of 9.3 million beneficiaries, ~8 million used pharmacy
benefits at one or more POSs. Of 9.3 million eligible TRICARE beneficiaries, retirees and family
members <65 years of age account for 34.1%, retirees and family members >65 years of age
account for 20.1%, and active duty personnel and their family members account for 18.3%.
TRICARE beneficiaries cover the full spectrum of age groups from neonates to the geriatric
population. TRICARE purchase care POSs include specialty and primary care provided by
retail pharmacy networks, the mail order pharmacy and other civilian network providers.
TRICARE direct care POSs include specialty and primary care provided by military treatment
facilities (MTFs).
DoD developed the Fentanyl Patch Patient Safety Program due to severe reactions and
fatalities caused by fentanyl transdermal patches nationwide. In June 2005, the manufacturer
issued a “Dear Healthcare Professional” letter to outline the indications and safe use of fentanyl
patches, reiterate their use for persistent/moderate pain to severe/chronic pain, and require
patients to be opioid-tolerant prior to use.
In July 2005, the Food and Drug Administration (FDA) issued a public health advisory warning
to emphasize safety issues. The Institute for Safe Medication Practices and DoD also issued
safety alerts in 2005. After MTFs reported three deaths from inappropriate use of fentanyl
patches in July 2006, the manufacturer and DoD issued a second alert to describe potential
dangers to patients if patches were exposed to external heat sources. DoD reviewed 48
medication errors by MTFs related to patients not being opioid-tolerant prior to placement on
fentanyl patches or confusion about appropriate dosages.
Despite the advisory warnings and safety alerts, fentanyl patches continued to be incorrectly
prescribed and used. To prevent further errors, the U.S. Air Force enacted a policy in July 2006
that limited provider prescribing of fentanyl patches to pain specialists, oncologists and other
authorized prescribers. The policy also required a pharmacist drug utilization review (DUR). A
recommendation on safety intervention by the DoD Pharmacy and Therapeutics Committee was
formally approved in January 2007 and implemented in August 2007 in retail and mail order
pharmacy POSs only.
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The Fentanyl Patch Patient Safety Program focuses on opioid tolerance and uses an automated
profile review (APR). The first step in the APR process is for the pharmacist to use the
Pharmacy Data Transaction System (PDTS) to review the patient profile and determine whether
a strong opioid was dispensed within 60 days of the patient receiving the fentanyl patch.
The pharmacist will or will not dispense the fentanyl patch depending on whether the patient
profile showed receipt of a strong opioid within the last 60 days. The pharmacist can override a
reject code in the system based on a review of the patient profile or discussions with the patient
or physician. Patients who are not opioid-tolerant could still receive the fentanyl patch by paying
cash or using health insurance other than TRICARE. Pharmacists also could dispense a pain
medication other than the fentanyl patch to the patient.
The 88SR reject code is an industry standard that was developed by the National Council on
Prescription Drug Programs. The DUR reject error only applies to fentanyl patch prescriptions
at this time. The pharmacist receives a reject message to confirm opioid tolerance due to no
documented strong opioid use in the past 60 days along with a telephone number to ask
questions or discuss options with the TRICARE Pharmacy Benefits Manager. The pharmacist
then makes decisions on overriding or not overriding the reject code and is required to enter
interaction and outcome codes into the system.
During the evaluation of the Fentanyl Patch Patient Safety Program in August 2007, a “strong
opioid” was defined as any Schedule CII drug. No future rejects were entered into the system if
the CII drug was established as an open-ended prior authorization during the look-back period.
The program was modified in July 2008 to address this gap. The new definition of “strong
opioids” explicitly identified fentanyl, morphine, hydromorphone, methadone, oxymorphone and
single-ingredient oxycodone products. The new policy also stated that patients with >60-day
intervals between prescriptions would encounter another reject.
After the Fentanyl Patch Patient Safety Program was implemented and refined, DoD performed
an analysis to evaluate the impact of the APR policy on fentanyl patch use among opioid-naïve
patients who used retail or mail order POSs. The study was designed to answer three key
questions: (1) What patients were affected? (2) What was the response? (3) Were appropriate
patients targeted?
The retrospective observational cohort study was based on PDTS data from TRICARE
beneficiaries with a paid claim or an 88SR reject for the fentanyl patch between August 1, 2007
and May 31, 2008. However, additional records were reviewed through June 15, 2008 for
follow-up measures. The data analysis included means and standard deviations for continuous
data as well as counts and percentages for categorical data.
Key findings of the study are summarized as follows. Of 26,366 patients who presented to
pharmacies with fentanyl patch prescriptions, 62% encountered no problems with the APR
process and 38% received 88SR reject codes. Of 10,025 patients with 88SR reject codes, 80%
obtained a pharmacist override and received the fentanyl patch, while the remaining 20% did
not obtain a pharmacist override and did not receive the fentanyl patch. Older adults, females
and non-active duty personnel accounted for the majority of patients who received 88SR rejects.
Of 16,341 patients who did not receive 88SR rejects, 97% had been on a fentanyl patch, strong
opioid or both. The number of pharmacist overrides was higher at the beginning of the study in
August 2007 than at the end of the study in May 2008. The following intervention and outcome
code combinations were used to override 7,982 88SR rejects: 55% of pharmacists filled the
26
prescription as is and the remaining 45% of pharmacists consulted with physicians before
overriding the reject code and dispensing the fentanyl patch.
Of 10,025 patients with 88SR rejects, 82% eventually received the fentanyl patch within seven
days, 83% received the patch within 14 days, and 86% received the patch at any time through
June 15, 2008. In terms of the mean time between the 88SR reject and subsequent paid claim,
90% of patients received the fentanyl patch within one day and 95% received the patch within
one week. Patients with higher fentanyl patch doses of 50, 75 and 100 micrograms did not
receive rejects. Older adults, females and non-active duty personnel accounted for the majority
of patients who received pharmacist overrides to 88SR rejects.
Of 2,043 patients with 88SR rejects due to any opioid use who did not receive pharmacist
overrides, 42% received any opioid within seven days, 45% received any opioid within 14 days,
and 59% received any opioid ever. For purposes of the study, “any opioid use” was defined as
tramadol and other strong and weak opioids. Of 832 patients with 88SR rejects who did not
receive pharmacist overrides or opioids through June 15, 2008, 48% had no paid claims after
the 88SR reject, 21% had no paid claims after the 88SR reject or in the previous year, 10%
received other pain medications, and 7% had evidence of health insurance other than TRICARE
in the previous year.
The study showed that MTFs performed better than retail or mail order pharmacies in assuring
appropriate usage of fentanyl patches. This finding was due to the fact that the military has
more control and authority over MTFs than retail or mail order pharmacies. By branch of
service, Army MTFs performed better than Navy and Air Force MTFs in detecting prior opioid
use among patients within the last 60 days prior to the first fentanyl patch prescription during the
study period.
Overall, ~38% of patients who were prescribed fentanyl patches during the study period were
flagged as potentially opioid-naïve. The Fentanyl Patch Patient Safety Program provided an
additional warning to pharmacies for patients who appeared to have a higher risk of adverse
drug events. Patients affected by the program had lower initial fentanyl patch doses compared
to those not affected due to prior opioid exposure. Overrides that occurred appeared to be
promptly managed by pharmacies.
Despite the efforts of the Fentanyl Patch Patient Safety Program, retail network pharmacies
appeared to have a higher rate of inappropriate fentanyl patch use among seemingly opioidnaïve patients compared to MTFs. Program modifications that were implemented in July 2008
resulted in a number of changes.
Prior authorizations would remain on patient profiles, but these changes would only apply to
new fentanyl patch patients. If strong opioids were detected in the look-back period, a shortterm prior authorization would be established within seven days to allow prescriptions to be
filled. However, future rejects could occur in the system. DoD anticipates an increase in the
number of 88SR rejects due to its more conservative definition of “prior strong opioid use.”
The APR policy reduced the use of fentanyl patches among seemingly opioid-naïve patients.
Novel application of the APR policy provided additional data to pharmacists during prospective
DURs. However, more research is needed to analyze the association between the APR policy
and the risk of respiratory depression within the military healthcare system; prevent adverse
events related to fentanyl patches; and educate prescribers and pharmacists on the need to
more closely examine TRICARE beneficiaries who present with fentanyl patch prescriptions.
27
*****
The state partners made additional comments and suggestions to strengthen linkages and
collaboration among Medicaid, private insurers and other stakeholders in developing
prescription drug overdose prevention strategies.
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Insurers and other stakeholders should perform economic analyses to measure the
actual cost of prescription drug overdose deaths in their respective patient populations.
This information could be a powerful tool for policymakers to change policies and
leverage funding for PMPs at the state level.
Resources other than collaborations should be compiled and widely distributed to
support the prescription drug overdose prevention initiative. For example, Washington
State recently presented its opioid dosing guidelines to the Transitional Warrior Program
to assist the military in addressing the same problems with chronic pain and opioid use
in a different population. This strategy would help to broadly publicize technical
assistance, specialty knowledge and subject matter expertise that are currently available
in the field of prescription drug overdose prevention.
Medicaid and private insurers should be extensively engaged in the prescription drug
overdose prevention initiative to determine their roles in providing direct financial support
to PMPs and other state efforts.
28
Overview of the Washington State Opioid Dosing Guidelines
WASHINGTON STATE OPIOID DOSING GUIDELINES
Dr. Gary Franklin is a Research Professor at the University of Washington School of Public
Health and a Medical Director for the Washington State Department of Labor and Industries.
He gave a provider perspective on state strategies for preventing prescription drug overdoses.
Most state regulations on opioid use for chronic and non-cancer pain were revised in the late
1990s from “prohibition of use” to “use without dosing guidance.” The policy change most likely
was due to low-grade studies that supported the rarity of “true addiction,” strong advocacy for
treatment, and “disciplinary fatigue” because physicians previously were not allowed to use any
opioids for chronic pain.
The 1986 Portenoy and Foley retrospective case series on chronic non-cancer pain was the
sentinel study that led to the change in opioid use policy. Of 38 patients in the study, 19 were
treated for at least four years and 24 had acceptable pain relief. However, only four patients in
the study received >40 mg MED/day. Moreover, the study did not document any gains in social
function or employment. The study concluded that opioid maintenance therapy could be a safe,
salutary and more humane alternative. No clear evidence has been generated to date to
document the benefits of long-term opioid use for chronic non-cancer pain.
The 2000 Workers’ Compensation Guidelines emphasized the need to focus on the following
principles for prescribing oral opioids: a single prescribing physician and pharmacy, the lowest
possible dose, appearance of misuse of medications, emphasis on return-to-work, tracking of
pain and function with a 1-10 scale and measure of functional status, and no concomitant use of
benzodiazepines or sedative-hypnotics. An opioid treatment agreement signed by both the
patient and physician and written permission for the provider to conduct random urine drug
screening were included in the 2000 guidelines.
The U.S. DEA summarized national medical examiner reports on oxycodone-related deaths
from 2000-2001 to publish the earliest study on prescription opioid-related deaths. Of 464
definite or probable deaths identified in the study, nearly all of the patients received more than
one opioid, a short- or long-acting opioid, or an antidepressant. The study is still available on
the DEA web site.
A 2005 published study on opioid dosing trends and mortality in Washington State workers’
compensation programs from 1996-2002 documented 32 definite or probable deaths and a
dramatic growth in dosing for the most potent opioids. The 2005 Washington State study
demonstrated the possibility of quickly reversing the severe trend of opioid morbidity and
mortality by changing provider behavior related to dosing levels.
More recent workers’ compensation data in Washington State showed an increase in definite or
probable opioid-related deaths from 32 deaths in 1996-2002 to >100 deaths in 2004-2006.
These data also showed a dramatic shift of >50% from the use of Schedule III to Schedule II
opioids; a tremendous increase in average daily doses from ~80 milligrams/day to 140
milligrams/day; and a significant increase in definite and possible prescription opiate deaths. In
addition to morbidity, hospital discharge data in Washington State also showed a dramatic
29
increase in severe mortality due to hospitalized overdose cases. Washington State is in the
upper tier of states in terms of unintentional poisoning deaths.
A 2007 published study highlighted the most frequent suspect drugs in deaths and serious nonfatal outcomes that were reported to the FDA from 1998-2005. Opioid analgesic drug classes
were in the top six of the 15 most frequent suspect drugs in deaths and serious non-fatal
outcomes. The causes of death most likely were due to dramatically increasing average daily
doses that were not proven to be associated with improved outcomes and most likely were
related to increased tolerance. Tolerance for euphoric effects likely precedes tolerance for
respiratory depression.
Research is now being conducted to determine a relationship between dose and morbidity or
mortality effects. A 2007 published study focused on central sleep apnea and ataxic breathing
related to chronic opioid use. The retrospective cohort study included 60 patients on chronic
opioids and showed a 92% prevalence of ataxic or irregular breathing during non-rapid eye
movement sleep at 200 mg MED. A new study with 9,000 enrollees on opioids for at least three
months in a large prepaid health plan documented a dramatic 24-fold increase in risk for
combined morbidity and mortality at 100 mg/day MED and a two-fold increase at 20 mg/day.
This study illustrates the uncertainty in determining a safe dose for taking opioids long-term for
chronic non-cancer pain.
CDC’s position is that the extent to which increases in opioid-related deaths have been due to
specific prescribing practices, improper usage of medications by patients, diversions of drugs
from patients to other persons, or other means has been difficult to determine. In May 2007, a
pharmaceutical company submitted an opinion in response to Washington State’s dosing
guidelines. The opinion stated that accidental deaths involving opioid analgesics were more
often due to abuse or misuse of opioids rather than therapeutic use of opioids for chronic pain.
In May 2007, The New York Times published an admission of guilt of deceit in marketing from a
narcotic maker that pleaded guilty to criminal charges and agreed to pay $600 million in fines to
states. A 2007 published study concluded that the evidence supporting long-term analgesic
efficacy is weak overall. The study further concluded that the putative mechanisms for failed
opioid analgesia might be related to rampant tolerance or opioid-induced hyperalgesia. The
study also questioned the premise that tolerance could always be overcome by dose escalation.
A large epidemiological study was conducted in Denmark with thousands of opioid and nonopioid patients and found that the quality of life was better in non-opioid patients with chronic
pain than patients who were taking opioids long-term. Another problem with opioid usage is that
a clear case definition has not been developed to date to distinguish between the true incidence
of “addiction” versus “craving.”
In an effort to address opioid-related morbidity and mortality, 15 clinical pain specialists in the
Washington State Agency Medical Directors Group (AMDG) developed the Opioid Dosing
Guideline in 2006 as an educational pilot with 120 mg serving as the “yellow-flag” dose. Formal
evaluation is underway to assess providers’ experiences with the guideline. The expert
advisory clinical group will be reconvened to review the evaluation outcomes and plan next
steps in refining the guideline. In February 2009, data from the guideline will be disseminated to
all 12,000 prescribing physicians in Washington State.
Part I of the opioid dosing guideline focuses on new patients who have not experienced clear
improvement in pain and function at 120 mg MED. The guideline recommends maintenance at
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the same dose, a decrease in the dose, or a one-time pain management consultation with a
certified pain specialist, neurologist or psychiatrist. This strategy will help to prevent the
development of a new cohort of patients with opioid addictions or problems.
Part II of the opioid dosing guideline is targeted to patients who are already on very high doses
>120 mg MED. Techniques are offered to physicians to effectively reduce doses in a fairly short
period of time of 3-6 weeks. The guideline also includes a web-based opioid dosing calculator
that provides an appropriate MED in real time and two hours of free online CMEs. The state of
Utah and the American Pain Society also developed opioid guidelines, but these two sets of
recommendations do not offer specific dosing advice on opioids. At this time, the Washington
State guidelines are the only set of recommendations that attempts to reduce or prevent high
opioid doses in new patients.
In addition to the lack of guidance on opioid dosing, efforts must be made to solve the significant
problem of access to pain specialists. In Washington State, only 13 certified pain specialists
agreed to serve as “resource consultants” for the AMDG web site and no pain specialists in
Spokane were willing to see patients with chronic pain who were on opioid doses of 120 mg/
day. In an effort to resolve the access problem, advanced training should be offered for primary
care physicians to become qualified to mentor other providers.
CDC testified before Congress in March 2008 on proposed prevention measures and made the
following recommendations: take advantage of out-of-state PMPs, modify patient behavior with
insurance mechanisms, screen for drug misuse in EDs, provide practice guidelines for primary
care, and make painkillers tamper-resistant.
Overall, dramatically increasing opioid doses and deaths occurred rather quickly after the law
changed. Guidelines with “best practices” were developed quite some time ago, but have had
minimal effect. A focus on opioid dosing is the most likely method to prevent high doses related
to severe morbidity and mortality.
More emphasis should be placed on severe long-term effects of opioids beyond morbidity and
mortality from overdoses. Most notably, Washington State published a prospective cohort study
on early opioid use and disability among 1,843 workers with acute low back injury in 2008. The
study showed that workers who received at least two opioid prescriptions in the first six weeks
post-injury were twice as likely to be on disability one year later even after adjusting for pain,
function and injury severity.
*****
The state partners made a number of comments and suggestions to strengthen linkages and
collaboration among physicians, nurses, other prescribing and non-prescribing providers, and
professional associations of providers in developing prescription drug overdose prevention
strategies.
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Collaborations should be formed with schools of medicine to provide more coursework
on the provision of pain management. The medical community has expressed concerns
about the lack of training on pain management provided during medical school.
Partnerships should be developed with professional organizations throughout the
country to assist in providing practicing physicians with continuing medical education on
pain management and patient medication safety. Groups that should be involved with
creating prescriber education guidelines, offering incentives, and establishing standards
or requirements for pain management training include state medical societies, state
31
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boards of medicine and pharmacy, state licensing boards, school health nurses, the
American Medical Association and the Joint Commission. CDC or DEA should be asked
to provide national leadership in this area. At the state level, individual physicians or
states could write letters to professional organizations to request assistance in this effort.
Psychologists and psychiatrists should be included in provider education and training
activities. These providers should be trained in determining whether their patients have
pain and conducting behavioral techniques if opioid abuse is occurring.
Prescription drug overdose prevention resources should be offered to states free of
charge, such as a national model, access to training, dosing guidelines, and other
practical tools that could be integrated into existing daily practice.
Cost-effective technologies should be implemented to provide training to providers.
Innovative tools also should be provided to physicians to increase the efficiency of their
practices. For example, Washington State is currently conducting beta tests on using
tele-medicine to link pain specialists to rural primary physicians. Washington State
sponsors a number of webinars for physicians to engage in computerized consultations.
Washington State also has created a computerized program to automatically calculate
MEDs of all controlled substances for physicians to rapidly use this information.
Previous efforts by workgroups should be reviewed as guideline development models to
avoid duplicating efforts. For example, workgroups formed by the Health Resources and
Services Administration (HRSA), CSTE, STIPDA and other national organizations
should be coordinated to pool existing resources and identify more cost-effective
strategies in developing guidelines, providing training, and compiling and disseminating
promising or best practices, models and other prescription drug overdose prevention
tools.
SAMHSA’s web-based portal should be reviewed as a model in providing a centralized
location for persons to access information on prescription drug overdoses. SAMHSA is
partnering with other federal agencies to create a Center of Excellence to compile data,
conduct studies and disseminate information to stakeholders.
CDC’s antibiotic resistance activities should serve as model of providing education to the
public.
Patient safety education activities should be designed to engage patients as true
partners in the healing and treatment of prescription drug overdoses. Uniform providerpatient partnership models should be developed in this effort to ensure that education is
provided and information is disseminated in a consistent manner across the country.
32
Overview of Utah Clinical Guidelines on Prescribing Opioids
UTAH CLINICAL GUIDELINES ON PRESCRIBING OPIOIDS
Ms. Erin Johnson is a Pain Management Program Manager in the Utah Department of Health
(UDH). She gave a provider perspective on state strategies for preventing prescription drug
overdoses. Utah ranks as the second highest state in the country for persons >24 years of age
who use pain relievers for non-medical purposes. Non-illicit drug overdose deaths increased
from 32 in 1991 to 317 in 2007 and are now the number one cause of injury death in Utah. The
state also has seen a dramatic increase in the number of methadone-related deaths from 2000
to 2004.
UDH developed Clinical Guidelines on Prescribing Opioids due to a legislative mandate. The
guidelines were designed to provide advice to primary care and specialty physicians in Utah on
prescribing opioids for both acute and chronic pain. The purposes of the guidelines are to
provide recommendations that balance the benefits and risks of opioid use to individuals and
society and disseminate useful tools to practitioners.
UDH initiated the guideline development process in June 2007 by establishing a steering
committee to determine key questions, the scope of the guidelines, and inclusion criteria for the
evidence review process. The literature review covered 40 existing guidelines on pain, chronic
pain, opioids, pain management and related topics. Inclusion criteria for the evaluation were
studies published after 1999 that provided disclosure of funding. The studies were scored on an
evidence-based versus consensus-based process.
Of the 40 sets of guidelines evaluated, four received scores <8, but two additional sets were
also included in the evaluation. UDH engaged three public health professionals to review the
ratings for consistency. The Guidelines Recommendation Panel was formed with 12
multidisciplinary experts to provide recommendations based on six sets of evidence-based
guidelines. The Implementation and Tool Panel was formed with 12 experts to review the
recommendations, determine the feasibility of implementation and identify tools for inclusion in
guidelines.
UDH took several activities during the recommendation development process in April-July 2008.
Selected guidelines were reviewed for commonalities and an outline was developed based on
recommendations that were supported by multiple guidelines. A Wiki was used to add new and
edit existing recommendations online and create a draft of the guidelines. A third meeting was
held to thoroughly discuss each recommendation, take a straw poll, revise the draft, and reach
consensus on the final draft.
After the guidelines were finalized, UDH initiated the tools development process in July-August
2009. The 47 identified tools were reviewed and scored from 1-5 based on their usefulness.
Tools with average scores >2 were immediately eliminated and discussions were held to
include, modify or eliminate the remaining tools. The selected tools included sample contracts,
treatment plans, drug screens, screening tools to determine good candidates for opioids or
identify persons at potential risk for opioid abuse, a directory of available resources in Utah, and
a take-home monitor for patients to track improvement in pain and function.
33
The recommendations on opioid treatment for acute and chronic pain provide guidance to
clinicians in the following areas:
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Appropriate and inappropriate use and prescription of opioid medications, including
patient education on proper disposal of medications and information to patients on
various risks and benefits.
Comprehensive evaluation of the use of opioids.
Adequate therapeutic trials and other alternatives to opioid treatment.
Opioid screening prior to initiation of treatment to detect potential risks for abuse or
addiction.
Development of a treatment plan with measurable goals.
Provision of information to patients via a written and signed treatment contract and plan.
Initiation of a treatment trial with specific goals for long-term opioid use.
Regular face-to-face visits with patients to evaluate progress against treatment goals
and monitor the patient.
Circumstances requiring clinical consultation, including patients with complex pain
conditions, serious co-morbidities, or a history of current drug addiction or abuse.
Appropriate prescription of methadone.
During the 45-day open comment period, UDH received >100 comments. Comments from the
general public primarily focused on the requirement to present to a specialist, “government
intrusion” of undergoing drug testing, and the need for public protection due to the ability of
opioids to cause addiction and destroy lives. The technical and clinical comments primarily
focused on the pros and cons of upper opioid doses, the complexity of drug testing, potential
risks for liability to physicians, and the sleep study recommendation.
UDH will publicize and disseminate the guidelines over the next month through a number of
venues, such as online and print formats, physician education presentations, and e-mail
messages to physicians, hospitals, the Utah Medical Association and other groups.
In addition to developing the Clinical Guidelines on Prescribing Opioids, Utah also has taken
other actions to prevent prescription drug overdoses. State legislation was passed in 2007 that
authorized UDH to conduct research on the causes, risk factors and solutions to prescription
drug overdoses and also to educate healthcare providers, patients, insurers and the general
public. UDH conducts these activities in collaboration with its Steering Committee, Advisory
Committee and workgroups that focus on specific issues, such as patient and community
education; policy, insurance and incentives; and data, research and evaluation.
UDH obtains input and endorsement from diverse groups throughout Utah that represent state
government, professional societies, and private and non-profit organizations. UDH provides
education to physicians through small group training sessions, large group presentations and
mailings. The physician education and training activities offer up to 20 CMEs.
UDH launched a media campaign in January 2008 to provide education to patients and the
general public on prescription drug overdoses. The campaign was publicized through a public
opinion survey, “Prescription Awareness Week,” key messages, community and press events,
and television and radio broadcasts. Collateral materials for the media campaign include the
“Use Only as Directed” logo, a web site, color poster, bookmarks in English and Spanish,
double-sided cards, print advertisements, media kit, window clings, quick screen display and
34
banner. The collateral materials have been tailored to meet the needs of a variety of audiences
throughout Utah.
Ms. Johnson informed the state partners that other states and organizations are free to use and
adapt UDH’s media campaign materials and templates to meet local needs. She concluded her
overview by presenting the television and radio advertisements of the media campaign. She
noted that the web site of UDH’s media campaign is www.useonlyasdirected.org.
*****
The state partners made a number of comments and suggestions to strengthen linkages and
collaboration with providers in developing prescription drug overdose prevention strategies.
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Innovative strategies should be developed to overcome resource limitations or other
barriers to evaluating prescription drug overdose prevention initiatives. Schools of public
health, master’s or Ph.D. candidates, CDC-funded Injury Prevention Research Centers,
Health Promotion and Disease Prevention agencies, and research organizations across
the country might serve as creative approaches to supplementing or augmenting existing
evaluation resources. Most notably, the collection and wide dissemination of strong
evaluation data from UDH’s impressive and multi-factorial “Use Only As Directed” media
campaign and tools for the Clinical Guidelines on Prescribing Opioids will be important in
informing other states about effective and ineffective prescription drug overdose
prevention activities.
State epidemiologists should be engaged in the prescription drug overdose prevention
initiative due to their strong credibility with physicians in states. Collaborations should be
formed with CSTE, STIPDA and school health nurses to support this effort.
Communication campaigns to providers, patients and the general public should be
included in the broader prescription drug overdose prevention initiative.
Local endorsement should be obtained from stakeholders to assure implementation and
success of prescription drug overdose prevention activities at the local level.
The possibility should be explored of leveraging funds from pharmaceutical companies
to support and promote prescription drug overdose prevention messages and other
efforts.
National pharmacy organizations and other groups that advocate for safe medication
practices should be engaged in the prescription drug overdose prevention initiative, such
as the Institute for Safe Medication Practices, American Pharmacists Association and
American Society of Health-System Pharmacists.
35
Overview of the Consistent Care Program (CCP) for Frequent ED Users
THE CONSISTENT CARE PROGRAM
Dr. Darin Neven is the Medical Director of the Providence Sacred Heart Medical Center
(PSHMC). He gave a hospital perspective on state strategies for preventing prescription drug
overdoses. The CCP was developed to reduce inappropriate ED visits and controlled
substance prescriptions and administration in EDs. The CCP targets patients who over-utilize
EDs. The goals of the CCP are achieved by coordination of care with primary care physicians
and individualized Emergency Department Guidelines that are accessible to all emergency
physicians throughout the city.
The CCP is guided by a number of core principles. Actions are always taken in the best interest
of the patient. Enabling of non-therapeutic behavior is prevented. Care is coordinated, but the
primary care provider maintains control. Prescription overmedication or abuse is prevented.
Patients are empowered to treat themselves. A collaborative information technology system
was established for the four hospitals in Spokane, Washington to use the same hospital data
system.
The CCP was designed to address the problem of frequent ED use. Patients frequently use
multiple EDs for pain medication, have concurrent mental health problems, report chronic pain,
and are Medicaid or Medicare beneficiaries. Frequent ED users typically have a primary care
physician and a preferred hospital, but are generally not forthcoming regarding their medical
history or previous testing. PSHMC’s pilot study showed that 90% of 48 patients had a
government payer.
The steps involved in the CCP process include selection of a frequent ED user by the clinician;
identification of the patient via a 24-hour referral line; research on the patient’s medical history;
review of the information for appropriateness; telephone consultation between the Program
Coordinator and primary care physician; presentation of recommendations by the clinician to an
ED Care Guidelines Committee; and development of individualized Emergency Department
Care Guidelines to prevent enabling of non-therapeutic behavior when the patient revisits the
ED. The committee members include a chaplain, psychiatric and ED nurses, pharmacist, ED
physicians and medical director.
The patient is notified about the CCP via a mailed letter, the guidelines are entered into the
shared hospital information system, and the data are distributed throughout the state of
Washington. Efforts are underway to create and launch the Emergency Department Information
Exchange. The web-based system will have the ability to add new hospitals, better manage
complex cases, monitor patients who are not in EDs, and track progress of the CCP.
The following process is implemented when CCP patients visit the ED. The patient’s ED chart
is flagged for the physician during hospital registration. The patient is triaged as usual, but the
physician will not prescribe controlled substances for pain patients based on a review of the ED
care guidelines. The ED physician performs a medical screening examination and the case
manager speaks to the patient prior to discharge to emphasize the message of consistent care
and determine the rationale for frequent ED visits.
36
The CCP is designed to seize teachable moments by automatically notifying the ED case
manager and medical director via a recorded telephone message and text message. Automatic
notification to the primary care physician, insurance company and ED via e-mail message and
facsimile is planned in the future.
PSHMC piloted the CCP from October-December 2006 and enrolled 40 patients who had an
average of 50 visits over a 12-month period. The maximum number of ED visits made by an
individual patient was 123 and the minimum number was 14. The 40 pilot patients collectively
made a total of 2,037 ED visits in the 12 months prior to enrollment. The 2,037 ED visits made
in the 12 months prior to enrollment were reduced to 1,022 ED visits in the 12 months after
enrollment. ED visits also decreased in all four of the Spokane hospitals. A positive impact was
seen in individual changes in ED visits one year after enrollment among the majority of patients.
In terms of cost-savings, the pilot showed a 33% reduction in Medicaid expenditures for ED
claims or savings of $2,379 in Medicaid ED expenditures per patient. Medicaid ED payments
per patient decreased from $7,228 in the 12 months prior to enrollment to $4,848 in the 12
months after enrollment. Similar savings were observed for total Medicaid expenditures.
Several solutions have been identified to overcome potential barriers to implementation of the
CCP. HIPAA issues do not apply because the CCP falls under the treatment category.
Consent forms should be used when needed. Emergency Medical Treatment and Active Labor
Act issues do not apply if medical screening examinations for CCP patients do not differ from
those for non-CCP patients. Hospital triage policies should be followed.
Physician liability concerns are addressed by providing sufficient medical information to aid in
decision-making and assuring follow-up by listing primary care physicians. Physicians are paid
based on responses to patient satisfaction surveys, but efforts are made not to administer these
surveys to frequent ED visitors. Hospitals treat complaints by frequent ED users differently than
complaints by non-CCP patients to ensure physicians are not unfairly penalized. Challenges
related to information technology can be met by using an external application service provider
with expertise in this area.
A number of guiding principles have resulted in the success of the CCP. An ED physician
should lead the project, but strong support and approval should be obtained from the top level of
the institution. Savings from inappropriate ED usage to hospitals, government payers and
uninsured payers should be emphasized. The overarching goal of the CCP to provide care that
is in the patient’s best interest and has the approval of the primary care physician should be
emphasized. Overall, electronic medical records alone are not the solution to frequent ED users
because a community-wide approach is needed. The CCP can lead to significant savings to
hospitals and payers. The most frequent ED users are Medicare or Medicaid beneficiaries.
*****
The state partners made a number of comments and suggestions to strengthen linkages and
collaboration with hospitals in developing prescription drug overdose prevention strategies.
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Existing federal and state models should be reviewed that promulgate brief interventions
and referrals to treatment in EDs. At the federal level, SAMHSA funds the Screening,
Brief Intervention, Referral and Treatment Program to provide substance abuse
screening in general medical and community settings, including community health
centers, school-based health clinics, student assistance programs, occupational health
clinics, hospitals and EDs. SAMHSA recently obtained approval for billing codes of the
37
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program. At the state level, the Massachusetts Department of Health allocated funding
for hospitals across the state to collaboratively implement the Emergency Department
Screening and Brief Intervention Program and hire health promotion advocates. Similar
to SAMHSA, Massachusetts is advancing toward developing billing codes for screening
of brief interventions and discontinuing state funding of this initiative. Massachusetts
also is interested in piloting the inclusion of its naloxone distribution project into EDs to
provide naloxone to opiate overdose patients before these high-risk persons are
discharged from EDs.
Communications related to chronic pain treatment should be enhanced among EDs at
the state level. Hospitals in Washington State have already initiated this effort by
developing guidelines for treating chronic pain in EDs.
Grand rounds and other forums should be utilized to provide education to ED physicians.
Benzodiazepines should be explicitly mentioned in pain guidelines because ED
physicians typically dispense these drugs with low-dose opiates or in lieu of opiates.
A pilot study should be conducted to explore the possibility of linking electronic medical
records and developing a standardized set of minimum data elements to facilitate
interoperability of hospital data systems. The National Information Exchange Model
should be reviewed in this effort because the tool is serving as the foundation for data
exchange of PMP data across states or into a centralized hub.
Efforts should be made to ensure that the hospital community is extensively involved in
the healthcare reform agenda of the new Administration in terms of electronic medical
records.
Regulatory- and policy-based solutions or legislation should be created to eliminate
political, bureaucratic and legal issues associated with sharing medical data.
States with PMPs should be encouraged to generate reports by hospital ED to identify
specific institutions that are prescribing prescription drugs and determine variations
among hospital EDs in terms of drug types and doses. These reports could help to
identify occurrences of “hospital ED shopping.” Patient visits could be used as the
denominator to generate hospital-specific reports with PMP, Medicaid and private
insurer data.
A feedback mechanism should be created to rapidly provide physicians with real-time
information on prescription drug overdose deaths in communities. Maine should be
reviewed as a model in this effort due to its development of Overdose Prevention
Groups that provide physicians with information on specific drugs involved in prescription
drug overdoses deaths in the community.
38
Overview of the North Carolina Chronic Pain Initiative and Project Lazarus
COMMUNITY: NORTH CAROLINA’S SuPRE DRUG PROGRAM IN WILKES COUNTY – THE
CHRONIC PAIN INITIATIVE AND PROJECT LAZARUS
Ms. Catherine Sanford is an Injury Epidemiology Consultant for the state of North Carolina.
She gave a community perspective on state strategies for preventing prescription drug
overdoses by describing the five necessary components of a Surveillance, Prevention, Rescue
and Evaluation (SuPRE) Program.
Component 1 of a SuPRE Program is solid knowledge of the community and the establishment
of coalitions to develop strong community drug overdose programs. In terms of community
knowledge, Wilkes County, North Carolina has a population of 68,000 persons; a median
income of $34,258; a poverty rate of >12%; layoffs by major employers; minimal heroin abuse;
incidence of >600/100,000 drug-related ED visits at the regional hospital; and a drug overdose
mortality rate of >36/100,000 for cocaine, methadone and other prescription controlled
substances.
In terms of coalitions, community partners in Wilkes County represent substance abuse, health
care, public health, law enforcement, faith-based organizations, domestic violence, child abuse,
schools, parents and teens, and nonprofit organizations. Community knowledge and the
formation of coalitions also should include estimates of the cost of prevention and rescue efforts
as well as the cost of not conducting these activities.
The three-dimensional Haddon matrix can be used to strengthen community knowledge. The
matrix analyzes 12 different factors to implement intervention strategies, provides criteria to
inform decision-making, and serves as a tool to prevent drug-related adverse events in
outpatient and other settings. After a pilot study is conducted with positive outcomes and the
community accepts the concept of the project, funding and politics become local.
Component 2 of a SuPRE Program is surveillance of mortality, ED and PMP data. Wilkes
County uses a number of resources to track accidental drug-related issues, such as death
certificates, ME investigations, the state Poison Control Center, ED visits, and the North
Carolina PMP. Unintentional drug-related deaths from 2003-2007 have increased in both North
Carolina at the state level and Wilkes County at the local level.
Methadone, oxycodone, cocaine and fentanyl accounted for the majority of unintentional
poisoning deaths in Wilkes County in 2007, but Xanax, alcohol and tramadol were contributing
factors as well. The average age of these decedents was 40 years. PMP data showed that
most residents in Wilkes County never fill >2 prescriptions in a single month, but some residents
have >5 prescriptions for a controlled substance. The most rural areas of the state accounted
for the highest mortality rates per 100,000 population and the highest prescription rates per
10,000 population.
Component 3 of a SuPRE Program is prevention. The Northwest Community Care Network
(NCCN) covers six rural North Carolina counties and is one of 15 Medicaid regulatory
authorities in the state. NCCN developed the Chronic Pain Initiative (CPI) to educate physicians
on pain management; distribute a pain management toolkit; modify ED opioid use; provide case
39
management of ED and Medicaid patients; use the Controlled Substances Reporting System;
decrease the cost of medical care; and pilot a study of Project Lazarus in Wilkes County. CPI
programs apply to physicians who treat Medicaid patients in the six-county area.
NCCN devotes a considerable amount of resources and conducts a significant number of
activities to support the following goals of the CPI: physician education, a CPI best practice
toolkit, guidance to EDs, case management, a pharmacy home, mental health, the North
Carolina PMP, efforts to decrease the cost of treating Medicaid patients, and piloting of Project
Lazarus.
Two major focus areas of the CPI are summarized as follows. Mandatory data reporting to the
North Carolina PMP became effective in July 2007. The secure web-based database is
password protected, provides online access to patient prescription profiles, and maintains data
on ~1 million prescriptions per month. Education is provided to physicians and office staff on
access and utilization of the PMP. However, physicians have raised serious concerns regarding
the current lag time of 2-4 weeks between reporting and making PMP data available.
Project Lazarus was designed to provide opioid antagonist naloxone as rescue medication for
potentially fatal respiratory depression from opioid overdose to pain patients and all other Wilkes
County residents who are at risk. Persons with substance use disorders are also targeted for
inclusion in the program through ED and substance use treatment services. Recruitment and
enrollment into Project Lazarus will be made simultaneously to de-stigmatize interventions.
The three key goals of Project Lazarus are to (1) reduce deaths and ED visits related to drug
overdoses and substance abuse; (2) initiate education by distributing naloxone kits and routinely
co-prescribing naloxone with high-dose opioid prescriptions to high-risk patients; and (3)
demonstrate broad applicability of co-prescriptions of naloxone to high-risk patients in the
remainder of North Carolina and the country.
NCCN plans to pilot Project Lazarus and its five components: education, informed consent,
intake form, naloxone kit and rescue. A DVD and toolkit insert were developed to provide
education to patients and peers on Project Lazarus. These materials focus on patient
responsibilities in pain management; instructions on recognizing signs and symptoms of opioid
overdose, performing rescue breathing and administering naloxone; the importance of calling
911; and options for substance abuse treatment.
Project Lazarus was the first naloxone program in the South that was introduced into primary
and general medical practice as a patient safety issue, focused on prescription opioids, included
pain patients, utilized a community-based approach, and approved by a state medical board.
Component 4 of a SuPRE Program is rescue. A study on treatment provided prior to death from
unintentional drug overdoses in North Carolina from 1997-2001 showed that 59% of the deaths
occurred before emergency medical services or law enforcement arrived at the scene. The
study emphasized the need for revised concepts because prevention is not always effective.
The study also demonstrated the efficacy of naloxone in patient safety in addition to postexposure treatment or harm reduction.
An evaluation of naloxone use among intravenous drug users (IDUs) showed no overall
increase in drug use or frequency of use, no unexpected major medical side effects, and a
possible increase in the desire of IDUs to seek drug treatment. The evaluation also showed that
naloxone provided an excellent opportunity to identify appropriate use scenarios.
40
Component 5 of a SuPRE Program is an evaluation of outcome and process measures. The
outcome evaluation of Project Lazarus will include a quasi-experimental design to analyze
hospital ED visit trends, mortality trends, prescribed controlled substance trends, and drugs and
circumstances from ME reports. The process evaluation of Project Lazarus will include patient
experience and provider opinion surveys, pilot testing of the educational DVD, and monitoring of
unintended consequences.
Overall, the five necessary components of community knowledge and coalitions, surveillance,
prevention, rescue and evaluation should all be closely linked in designing a SuPRE community
drug overdose program.
*****
The state partners made a number of comments and suggestions to strengthen linkages and
collaboration with the community, NGOs and other stakeholders in developing prescription drug
overdose prevention strategies.
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The collaboration between the National Safety Council (NSC) and employer groups to
distribute information and deliver educational messages to unique audiences should be
reviewed as a model of providing prescription drug overdose prevention education to
patients and the general public.
Safety messages should be a key component of the prescription drug overdose
prevention initiative. NSC’s focus groups have shown that a focus on safety is effective
in reducing stigma of persons who abuse drugs.
NGOs should segment the content of prescription drug overdose prevention messages
and communication methods to deliver these messages based on the specific audience.
For example, information on proper storage and security of medications should be
targeted to seniors, particularly those who care for their grandchildren. Seniors who live
alone should be educated on the danger of discussing controlled substances that are in
their possession because common knowledge of this information could increase the risk
for home invasions to steal prescription drugs. Messages to parents should provide
guidance on prescription drug overdose prevention in both their children and their
children’s friends.
NGOs should develop and deliver action-oriented messages, such as the need for
persons to inventory their medicine cabinets and properly dispose of old prescriptions.
The Northern New England Poison Center is currently piloting messages on medication
safety and also has developed a take-home list of safe disposal recommendations for
the public.
Professional organizations within medical, pharmacy, public health and hospital provider
networks should be engaged to focus on advocacy for prescription drug overdose
prevention.
Community coalitions should be formed to develop strategies to reduce or prevent fatal
and non-fatal opiate overdoses in communities. The Massachusetts Department of
Health is currently allocating funds from a federal grant for local community coalitions to
undertake this effort.
NGOs should inform the public about state policies or laws for safe disposal of controlled
substances. For example, New Hampshire has designated 24-hour drop-off locations
for outdated prescription medications. Community coalitions and law enforcement in
Maine partnered to provide police officers with authority to collect controlled substances
from homes and deliver the drugs to pharmacies.
41
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Parent and survivor groups of family members who died from or currently abuse
controlled substances should be engaged as strong advocates for the prescription drug
overdose prevention initiative.
Collaborations should be established with retailers of controlled substances due to the
strong interest of this group in prescription drug overdose prevention. For example, drug
retailers in Utah routinely distribute UDH’s “Use Only as Directed” campaign materials.
Collaborations should be formed with hospices due to their important role in meeting the
needs of family members of patients who abuse controlled substances, such as applying
rigorous protocols for disposing of drugs after a patient has died. Hospices also can
serve as strong community advocates for changes in patient safety policies, such as
prescribing controlled substances to high-risk substance abusers.
42
Open Discussion
Ms. Amy Harris moderated an open discussion for the state partners to identify and describe
the potential roles and activities of other stakeholders in the prescription drug overdose
prevention initiative. Suggestions and comments by the state partners on this issue are outlined
below.
Role of Poison Control Centers (PCCs):
 PCCs generate timely and detailed data and can serve as a rich data source for the
prescription drug overdose prevention initiative. Moreover, PCC data are useful for
surveillance purposes, provide information on drug contamination, and can serve as an
early warning system of new drugs circulating through individual communities or new
techniques persons use to abuse existing drugs. PCC data also can be used for
evaluation purposes to assess decreases in drug diversion in communities that have
“take-back” drug programs.
 Previous efforts of PCCs at the state level should be reviewed to clearly define their role
in the prescription drug overdose prevention initiative. For example, the PCC and Injury
Prevention Program in North Carolina collaborated in using the Health Alert Network to
notify all physicians in the state about clenbuterol-contaminated heroin cases and
describe strategies to identify and treat these patients. The Maryland PCC has a HRSA
grant to conduct telephone assessments to detect substance abuse and provide abusers
with appropriate treatment options. Some state PCCs collect medication verification
data that serve as a better source for trend analyses than actual substance abuse
exposures. The Pennsylvania PCC identified a geographic cluster with a greater
increase in medication verifications and shared these data with law enforcement. Efforts
by the Pennsylvania PCC led to the identification of a pharmacist who was illegally
selling controlled substances.
 The prescription drug overdose prevention initiative should be designed to coordinate
educational outreach activities conducted by PCCs at the state level.
 PCCs launched and targeted extremely effective campaigns throughout the country on
safe storage and security of controlled substance to prevent unintentional poisoning
deaths or overdoses among children. PCCs should be encouraged to replicate and
target similar safety campaigns to seniors for the prescription drug overdose prevention
initiative.
 PCC resources should be gathered to inform the broader prescription drug overdose
prevention initiative. For example, educators have compiled a list of activities PCCs are
conducting related to prescription pain pills in preparation for “Poison Prevention Week.”
The Poison Workgroup is currently creating a clearinghouse that will maintain
surveillance data on poisonings and information on similar programs and activities. PCC
data on severe exposures or deaths in children <6 years of age from prescription
narcotic painkillers or unintentional methadone overdoses can be used to convey more
powerful and compelling prescription drug overdose prevention messages than deaths
among adult substance abusers or recreational drug users.
Role of Law Enforcement
 Washington State should be reviewed as a model in forming and deploying drug task
forces directly to communities to conduct substance abuse prevention activities.
43
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Attorney General offices nationwide should be engaged as a law enforcement partner in
the prescription drug overdose prevention initiative.
Role of Insurers
 The Utah Labor Commission has been heavily involved in the prescription drug abuse
epidemic at the state level. Injured workers in Utah who are on prescription medications,
but have no improvement in pain or function and do not return to work for lengthy
periods of time are a significant cost to state Medicaid and Medicare agencies.
Role of Other Stakeholders and Activities
 The National Association of State Mental Health Program Directors and other groups in
the mental health community.
 Prescription drug overdose education by pharmacies. SAMHSA recently piloted a
project in which medication safety information was distributed to 6,000 pharmacies
nationwide to determine the impact of pharmacies on educating patients. SAMHSA is
currently evaluating the pilot.
 Prescription drug overdose education by patients. Patients could play a significant role
in informing the development of prescription drug overdose prevention materials and
outreach activities that will be effective to high-risk patients. “Recovering” patients also
could be extremely useful in conveying their personal experiences and perspectives to
patients who are currently undergoing substance abuse treatment.
 Prescription drug overdose education by teens. School-based drug and alcohol
education programs primarily focus their messages and other materials on illicit drugs,
but prescription medications are a significant issue among teens as well.
 Administration of prescription drug overdose surveys in rehabilitation centers.
 Dissemination of prescription drug overdose information by faith-based organizations to
raise public awareness of the problem.
 Use of the HRSA-funded National Center for Child Death Review as a potential model to
solve problems with prescription drug overdose deaths and plan future prevention
strategies.
 An initial focus of the prescription drug overdose prevention initiative on adolescent drug
abuse because prescription drugs are the new “gateway” drug and now account for
more drug abuse than marijuana in this age group.
 Collection of data from the National Survey on Drug Use and Health.
 Revision of the current process to collect prescription drug overdose death data to
record more meaningful and relevant drug information on death certificates.
Role of CDC
 Convene other federal agencies to identify research priorities, better define the
magnitude and scope of the prescription drug overdose problem, and answer basic
research questions, such as the efficacy of using opiates for pain treatment.
 Augment the CDC-funded National Violent Death Reporting System by including data on
unintentional or accidental prescription drug overdose deaths.
 Develop and distribute a minimum data set with ~12 questions to facilitate the exchange
and comparison of prescription drug overdose data across states and promote
prescription drug overdose prevention at the state level. Extract data from ME
investigations to support this effort.
44
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Develop a “National Prescription Drug Overdose Prevention Research Agenda.”
Develop national guidelines with the following topics as a starting point: treatment of
chronic pain in EDs, strong endorsement of PMPs, and prescription drug addiction.
Encourage and produce surveillance of prescription drug overdoses at federal and state
levels to enhance knowledge of prescription drugs that are currently being used and
identify populations with the highest incidence and prevalence of prescription drug
overdose deaths. Partner with DOJ to increase the number of PMPs nationwide and
share prescription drug overdose data in a continuous, consistent and common format
across programs.
Create a web site or “one-stop-shop” for programs to post prescription drug overdose
prevention activities, education materials, promising or best practices, effective
interventions, media campaigns and other initiatives. Include contact information for the
programs.
Promote plausible or promising practices in prescription drug overdose prevention, but
conduct a rigorous evaluation at national, state and community levels first to validate and
determine the effectiveness of these activities.
Educate and inform federal partners, funding entities and policymakers about the critical
need to allocate more resources to establish new and strengthen existing PMPs at the
state level.
Partner with the Joint Commission to develop and deliver more complete messages on
treating pain without enabling addiction among patients.
Use the February 2009 STIPDA meeting as a forum to continue discussions on
prescription drug overdose prevention and gather more information on this issue from
state representatives.
Convene a meeting with medical associations to continue the dialogue on the
prescription drug overdose prevention initiative.
Inform the transition team of the new Administration about the important role of PMPs in
improving the medical infrastructure through medical informatics and electronic medical
records.
Serve as the national hub-and-spoke system for state PMPs.
Offer solid guidance and strongly urge states to use core injury program funding to
address prescription drug overdose prevention in the future.
Offer CME credits for physicians and other prescribers who complete prescription drug
overdose prevention training initiatives.
Partner with DEA to develop national standards or guidelines for proper medication
disposal.
Partner with the full spectrum of the education community to develop chronic pain
treatment guidelines and standardized training for medical, nursing and pharmacy
school students.
Develop a toolkit or talking points for providers to more easily discuss prescription drug
abuse and misuse with patients.
Ms. Harris led the state partners in a review of the broad list of activities that were proposed to
identify the most important areas CDC should invest resources at this time to make the most
significant and rapid impact in prescription drug overdose prevention. The top six priorities the
state partners identified for CDC to focus on at this time to advance the prescription drug
overdose prevention initiative are outlined below. (Note: the numbered priority list reflects the
order in which the state partners made suggestions and does not indicate ranking by order of
importance.)
45
1. Leverage resources with CSTE, STIPDA and other existing partners to conduct
surveillance of prescription drug overdoses.
2. Collaborate with the Poison Workgroup to compile materials for the new prescription
drug overdose prevention “one-stop-shop” web site.
3. Convene a wide and diverse group of stakeholders in the prescription drug overdose
prevention initiative, including federal and state partners, insurers, PCCs, the medical
community and NGOs.
4. Sponsor research and rigorously evaluate promising or best practices and effective
interventions in prescription drug overdose prevention. Leverage funding from the
National Institutes of Health and other federal partners to support this research effort.
Use the research and evaluation data to develop evidence-based prescription drug
overdose prevention guidelines and strategies.
5. Provide training to prescribers on prescription drug overdose prevention.
6. Make a strong cost-effectiveness case for the prescription drug overdose prevention
initiative and balance this argument against the societal cost of taking no actions to
prevent prescription drug overdose morbidity and mortality. Compile and disseminate
cost-effectiveness data from this research to assist state and local entities in leveraging
resources.
Closing Session
Dr. Grant Baldwin, Director of the NCIPC Division of Unintentional Injury Prevention, thanked
the CDC staff for planning, arranging and making logistical arrangements for this important
meeting. Dr. Leonard Paulozzi, the CDC Medical Officer, led the state partners in applauding
the keynote speakers for making outstanding and informative presentations.
Ms. Harris thanked the participants for providing CDC with candid dialogue and innovative
strategies over the course of the meeting to advance the prescription drug overdose prevention
initiative. She confirmed that CDC would regularly communicate with the state partners to
provide updates on next steps and other new developments in the prescription drug overdose
prevention initiative.
46
ATTACHMENT 1
List of Participants
Pam Archer, M.P.H.
Injury Prevention Service
Oklahoma State Department of Health
1000 Northeast 10th Street
Oklahoma City, OK 73117-1299
Phone: 405-271-3430
Fax:
405-271-2799
E-mail: [email protected]
Ileana Arias
National Center for Injury Prevention and
Control
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-4696
Fax:
770-488-4422
E-mail: [email protected]
Grant Baldwin
National Center for Injury Prevention and
Control
Centers for Disease Control and Prevention
4770 Buford Highway, Mail Stop F62
Atlanta, GA 30341-3717
Phone: 770-488-4696
Fax:
770-488-4422
E-mail: [email protected]
Michael Ballesteros
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-1308
Fax:
770-488-1317
E-mail: [email protected]
Dan Budnitz
National Center for Preparedness,
Detection and Control of Infectious
Diseases
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop A-24
Atlanta, GA 30329-4018
Phone: 404-639-4096
Fax:
404-639-4045
E-mail: [email protected]
Phyllis Coolen, RN, M.N.
Patient Review and Coordination Program
Division of Healthcare Services
Health & Recovery Services Administration
Washington State Department of Social
and Health Services
P.O. Box 45532
Olympia, WA 98504
Phone: 360-725-1395
Fax:
360-725-1969
E-mail: [email protected]
Gary Franklin, M.D., M.P.H.
Department of Environmental anD
Occupational Health Sciences and
Neurology
University of Washington
1914 North 34th Street, Suite 101
Seattle, WA 98103
Phone: 206-685-7080
Fax:
206-685-7031
E-mail: [email protected]
Mariana Garrettson, M.P.H.
Family Medicine and Community Health
The Commonwealth Medical College
501 Madison Avenue
Scranton, PA 18510
Phone: 570-504-9622
Fax:
570-504-9660
E-mail: [email protected]
47
Amy Harris
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-1484
Fax:
770-488-4222
E-mail: [email protected]
Melissa Heinen, B.S.N., M.P.H.
Education and Research Coordinator
Northern New England Poison Center
29 Hazen Drive
Concord, NH 03301
Phone: 207-232-9832
Fax:
603-271-4519
E-mail: [email protected]
David Hopkins, B.S.
Prescription Drug Monitoring Program
Office of the Inspector General
Kentucky Cabinet for Health and Family
Services
275 East Main Street, 5ED
Frankfort, KY 40207
Phone: 502-564-1012, ext. 3162
Fax:
502-564-7876
E-mail: [email protected]
John Horan, M.D., M.P.H.
Office of Epidemiology, Evaluation and
Health Information
Division of Public Health
Georgia Department of Human Resources
2 Peachtree Street, NW, Suite 14-430
Atlanta, GA 30303
Phone: 404-657-2611
Fax:
404-657-7517
E-mail: [email protected]
Larke Huang
Substance Abuse and Mental Health
Services Administration
1 Choke Cherry Road
Rockville, MD 20850
Phone: 240-276-2000
E-mail: [email protected]
Erin Johnson, M.P.H.
Bureau of Epidemiology
Utah Department of Health
288 North 1460 West
P.O. Box 142104
Salt Lake City, UT 84116
Phone: 801-538-6191
Fax:
801-538-9923
E-mail: [email protected]
Jennifer Ludovic
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-1492
Fax:
770-488-1668
E-mail: [email protected]
Paul Melstrom, Ph.D.
Georgia Department of Human Resources
2 Peachtree Street, NW
Atlanta, GA 30303
Phone: 404-657-9627
E-mail: [email protected]
Angela Mickalide, Ph.D.
Home Safety Council
1250 I Street, NW, Suite 1000
Washington, DC 20005
Phone: 202-330-4900
Fax:
202-330-4901
E-mail:
[email protected]
Darin Neven
Sacred Heart Medical Center
13620 West Charles Road
Nine Mile Falls, WA 99026
Phone: 509-466-1107
Fax:
509-466-1108
E-mail: [email protected]
Rita Noonan
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3737
Phone: 770-488-4652
Fax:
770-488-1317
E-mail: [email protected]
Leonard Paulozzi
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-1394
48
Fax:
770-488-1317
E-mail: [email protected]
Chester Pogostin
Division of Unintentional Injury Prevention
National Center for Injury Prevention and
Control
Centers for Disease Control and Prevention
4770 Buford Highway, Mail Stop F62
Atlanta, GA 30341-3717
Phone: 770-488-1565
Fax:
770-488-1317
E-mail: [email protected]
4052 Bald Cypress Way, Bin C15
Tallahassee, FL 32399
Phone: 850-245-4440, ext. 2729
Fax:
850-414-6470
E-mail: [email protected]
Monique Sheppard
Pacific Institute for Research and Evaluation
11720 Beltsville Drive, Suite 900
Calverton Office Park
Calverton, MD 20705-3102
Phone: 301-755-2728
E-mail: [email protected]
Sarah Ruiz, M.S.W.
Bureau of Substance Abuse Services
Massachusetts Department of Public Health
250 Washington Street, 3rd Floor
Boston, MA 02108
Phone: 617-624-5136
Fax:
617-624-5185
E-mail: [email protected]
Jessica Shisler
Centers for Disease Control and Prevention
4770 Buford Highway
Atlanta, GA 30341-3717
Phone: 770-488-1571
Fax:
770-488-1317
E-mail: [email protected]
Jennifer Sabel, Ph.D.
Injury and Violence Prevention
Washington State Department of Health
243 Israel Road, SE
P.O. Box 47853
Olympia, WA 98504
Phone: 360-236-2865
Fax:
360-236-2829
E-mail: [email protected]
David Sleet, Ph.D.
Coordinating Center for Environmental
Health and Injury Prevention
Centers for Disease Control and Prevention
4770 Buford Highway, Mail Stop F62
Atlanta, GA 30341-3717
Phone: 770-488-4699
Fax:
770-488-1317
E-mail: [email protected]
Catherine (Kay) Sanford, M.S.P.H.
Private Consultant
5701 Dedmon Court
Durham, NC 27713
Phone: 919-484-2795
E-mail: [email protected]
Marcella Sorg, RN, Ph.D., D-ABFA
Margaret Chase Smith Policy Center
University of Maine
5784 York Complex, Building #4
Orono, ME 04469-5784
Phone: 207-581-1648
Fax:
207-581-1266
E-mail: [email protected]
Nina Shah
New Mexico Department of Health
1190 St. Francis Drive
P.O. Box 26110
Santa Fe, NM 87502-6110
Phone: 505-476-3607
E-mail: [email protected]
Kyla Shelton, M.P.H.
Office of Injury Prevention
Florida Department of Health
Stacia Spridgen, Pharm.D.
Department of Defense
Pharmacoeconomics Center
2450 Stanley Road, Suite 208
Fort Sam Houston, TX 78213
Phone: 210-221-6596
E-mail: [email protected]
49
Daniel Stier
Public Health Law Program
Centers for Disease Control and Prevention
1600 Clifton Road, Mail Stop D30
Atlanta, GA 30329-4018
Phone: 404-639-4680
E-mail: [email protected]
Margaret Warner
National Center for Health Statistics
Centers for Disease Control and Prevention
3311 Toledo Road, Mail Stop P08
Hyattsville, MD 20782
Phone: 301-458-4556
Fax:
301-458-4038
E-mail: [email protected]
Amber Williams
State and Territorial Injury Prevention
Directors Association
2200 Century Parkway, Suite 700
Atlanta, GA 30345
Phone: 770-690-9000
Fax:
770-690-8996
E-mail: [email protected]
50
Report of the State Strategies for Preventing
Prescription Drug Overdoses Meeting
January 13-14, 2009
Page 1