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The Epidemic of Opioid Abuse and Diversion:
Public Health Implications, Primary Care
Needs and Usage of
Prescription Drug Monitoring Databases
Elizabeth A Cook, MD
Spring 2016
A Master’s Paper submitted to the faculty of
the University of North Carolina at Chapel Hill
in partial fulfillment of the requirements for
the degree of Master of Public Health in
the Public Health Leadership Program
Chapel Hill
Spring 2016
Cheryll Lesneski, DrPH
Date
S. Hughes Melton, MD, MBA
Date
2
Abstract
The last two decades have seen a dramatic rise in the abuse, diversion, and
overdose rates of opiate medications. This paper will look at the reasons behind the
surge, and the concerning statistics about overdoses and deaths resulting from
significantly expanded use of these medications. In order to stem the epidemic,
three key stakeholders have an opportunity to align interests in decreasing abuse
and overdoses. Primary care providers are major prescribers of opiate
prescriptions, yet they lack adequate training in chronic pain management,
screening for addiction, and counseling patients with opiate addiction. Collaboration
between public health organizations and primary care providers working to expand
addiction recovery services in the community, as well as to address the underlying
socioeconomic determinants of health, will be vital to the interventions. The
Prescription Drug Monitoring Database is a technological tool that is utilized to
track prescriptions of controlled substances. Improvement in interstate sharing and
interoperability with primary care providers’ electronic medical records will be
needed to ensure widespread usage by providers.
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Introduction
One of the leading challenges in the health of Americans is the surge in opioid
abuse, addiction and overdose. A product of shifting foci in the healthcare system, it
has grown to be one of the top public health challenges of today(Kolodny et al.,
2015). Combating this problem requires a strengthened alignment between the
medical community and public health organizations. Primary care providers are on
the frontline of managing access to opioid medications. Education regarding the
appropriate use of opioids, risks of opioid addiction and diversion, and
interventions to treat addiction are necessary to engage these providers in efforts to
decrease rates of addiction and abuse. Public health programs that support
addiction and rehabilitation programs, as well as interventions that address the
underlying social determinants that play a role in addiction and abuse, are also
essential. Use of technology such as the Prescription Drug Monitoring Databases
provides one tool that can be integrated into a multi-pronged approach to this crisis.
This paper looks at the reasons behind the current epidemic of opiate abuse, the
current state and costs of opiate abuse, the role of primary care in combating abuse,
the potential role of prescription drug monitoring databases and the need for
collaboration with public health programs that address addiction behaviors. This is
in no means a complete solution to a complex public health challenge but represents
several efforts that may ultimately lead to decreasing the tragic outcomes from
opioid abuse and addiction.
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History of Opioids
Opium use dates back to some of the earliest records of written history,
including use in religious ceremonies, as well as medicinally (Brownstein, 1993). In
the early 1800’s, morphine was isolated from the opium, followed by codeine a few
years later, and utilized in medical procedures as early as the mid 1800’s
(Brownstein, 1993). Because of the abuse potential of morphine, much effort was
put towards developing safer, supposedly non-addictive opiate derivatives. Heroin,
first synthesized in 1898, was touted as being non-addictive with no risk of abuse.
(Brownstein, 1993). Through the 1900’s other opioid derivatives were synthesized,
each held as the safer, non-addictive version of the opiate poppy seed (Brownstein,
1993). With increased use, it became clear such claims were not justified.
The first government regulation of opiate medications began with the
Harrison Narcotic Act of 1914 that required a written record by physician or
pharmacist (Shepherd, 2014). The first legislation that made certain medications
available only through prescription was passed in 1938. The 1970 Controlled
Substance Act placed regulation of certain medications, including pain medicines,
under the oversight of the Drug Enforcement Agency (Shepherd, 2014). The Act
identified several classes of medicines that were to be regulated by the DEA due to
their risk of abuse (Shepherd, 2014).
The legislation classified controlled substances into five classes based on risk
of abuse and addiction. Schedule I, those with the highest risk such as heroin, is
outlawed for any medical use. Schedule II – V are divided into groups with
decreasing risk of addiction and abuse. Schedule II includes morphine, high dose
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codeine, Demerol, oxycodone, hydrocodone and methadone. All five classes are
available only through prescription from prescribers who are registered with the
DEA (Shepherd, 2014).
As early as the 1970’s, states also enacted various legislation aimed at
regulating these medications. Most require providers to perform a patient
evaluation, including history and physical examination and an appropriate diagnosis
before prescribing these medications, in order to ensure that an opiate is medically
indicated for the patient (Shepherd, 2014). Most states also have laws that prohibit
obtaining prescription through misrepresentation or fraud, including the act of
“doctor shopping” which is fraudulently acquiring prescriptions from multiple
providers for non medical purposes (Shepherd, 2014).
Rise of the Narcotic Epidemic and Resulting Costs
The Centers for Disease Control has declared the abuse of prescription pain
medications to be an epidemic, causing more accidental loss of life than motor
vehicle accidents (Brandeis University, 2014)In 2009 there was a reported 79.5
million prescriptions written for narcotic pain medication (Meyer, Patel, Rattana,
Quock, & Mody, 2014). By 2012 this number had risen to 259 million (Dowell,
2016). The rise in rate of prescriptions for these medications can be traced to a shift
in focus on pain management that occurred in the last fifteen years (Inocencio,
2013).
In 1997 the Robert Wood Johnson Foundation gave financial support to the
Federation of State Medical Boards to make pain assessment and treatment integral
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to the US healthcare system (Agarin, Trescot, Agarin, Lesanics, & Decastro, 2015).
The Joint Commission on Healthcare, Accreditation and Certification (JCAHO)
followed by identifying pain control as standard of care that all health care systems
must attain. The “under-treatment” of pain was felt to represent substandard
medical care (Agarin et al., 2015; Manchikanti, 2007). In 2001, Congress declared
the “Decade for Pain Control and Research” (Inocencio, 2013). Additionally, several
medical organizations, including the American Academy of Pain Medicine, identified
the quality of pain management in the U.S. as being unacceptably poor (McCarberg,
2011). However, there was little effort at that time to increase the training and
education of medical providers to improve their skill and knowledge regarding
multidisciplinary pain management. A 2011 study showed a majority of US medical
schools provided a total of less than twenty hours of pain management training
throughout their undergraduate medical education (Mezei & Murinson, 2011).
What understandably followed was an explosion in the rates of opiate
prescription and subsequently opioid misuse, abuse, overdoses and deaths. In 2009
there were an estimated 12 million people who were considered “non-medical”
users of opioid medications, a ten percent increase from 2002 to 2009 (Meyer et al.,
2014; Ringwalt, Garrettson, & Alexandridis, 2015; Worley, 2012). Studies show that
prescription drug abuse is second only to marijuana in prevalence of drug abuse
(Meyer et al., 2014). Not surprisingly, rates of emergency department visits and
deaths have risen as well (Meyer et al., 2014). In 2009 there was an estimated
350,000 emergency department visits related to opioid abuse(Paulozzi, Strickler,
Kreiner, & Koris, 2015). By 2011 that number has risen to greater than 420,000
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(Dowell, 2016). Gudin cites an eighty-three percent increase nationally in opioid
overdose death from 2003 to 2008 (Gudin, 2012).
Current studies show that Americans consume eighty percent of all global
opiates and ninety-nine percent of all hydrocodone (Manchikanti, 2007). The
estimated lifetime risk of abusing opiate medications is twenty percent
(Manchikanti, 2007). Seventeen thousand people died from prescription drug
overdoses in 2010, more than heroin and cocaine combined (Shepherd, 2014). From
the period of 2009 to 2014, more than 165,000 people died from complications
related to opioid overdose (Dowell, 2016).
There has been a recent move by federal and state government agencies to
commit money to combating this epidemic (Manchikanti, 2007). Although a
substantial amount of direct money is committed to combating the problem, it is
only a fraction of the total costs of the epidemic. Total costs range from $9 billion to
almost $125 billion to address all the facets of opioid abuse (Meyer et al., 2014;
Shepherd, 2014). Aggregate costs include provision of healthcare, criminal
investigation, prosecution, and lost workplace productivity. Hansen, Oster,
Edelsberg, Woody & Sullivan (2011) placed total costs in range of $53 billion with
most of these costs attributed to lost productivity and crime. Costs of drug diversion,
the act of misappropriating opioids towards those who utilize for non-medical
reasons has been estimated to be as high as $72 billion (Worley, 2012).
The Office of Budget from the White House estimates $300 billion per year in
healthcare, insurance fraud, law enforcement, and lost productivity costs related to
non-medical use of opiates (Meyer et al., 2014). Healthcare costs include increased
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emergency department visits with twenty three percent of visits attributed to
problems related to opiate abuse and overdose (McCarberg, 2011), as well as costs
for programs for treatment of substance abuse (Gilson & Kreis, 2009). One recent
study estimates that 5500 people per day become new users of opiate medications
(Shepherd, 2014). Although not all of these people go on to become abusers, the
steady flow of opiate medications into society ensures that the epidemic will
continue until significant steps are taken to curtail the problem.
For the years 2002-2005, the National Survey on Drug Use and Health found
4.8% of people 12 years and older had consumed prescription painkillers for nonmedical reasons in the prior year (Hall et al., 2008). Studies have shown incidence of
drug abuse as high as 57% in patients receiving opioids for chronic pain
(Manchikanti, 2007). Of the over 11 million people who used prescription
medications for nonmedical reasons, 57% used hydrocodone and 21% used
oxycodone (Manchikanti, 2007). Of significant concern is the rate of abuse in teens.
In 2005 nearly 20% of all abusers of prescription medications were teenagers, with
many of these teens believing the medications are “safe” (Manchikanti, 2007).
Research by Shepherd estimates that 2 million people per year become new users of
prescription pain medications for non-medical reasons (Shepherd, 2014).
Sources of Opioids
Although traditional drug dealers and theft do provide a supply of opiates, it
is the minority source of most opiates in circulation used for non-medical purposes
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(Manchikanti, 2007). Up to 89% of these medications in circulation were obtained
legally through a prescription (Manchikanti, 2007).
Doctor shopping is the act of individuals going to multiple healthcare
providers in order to obtain prescriptions for medications through fraud or
misrepresentation (Worley, 2012). Based on a General Accounting Office study, the
justice department declared doctor shopping as a major source of medications in
circulation (Worley, 2012). However, the 2009 National Survey on Drug Use and
Health found that sixty percent of those using opiates for non-medical purposes
obtained them from a friend or family member. In the majority of cases, the same
medical provider was the source of repeat prescriptions (McCarberg, 2011).
Multiple studies have shown that most people using opiates for non-medical
purposes have obtained the medication through a friend or family member (Agarin
et al., 2015; Gudin, 2012; McCarberg, 2011).
Primary Care Providers
Multiple stakeholders are involved in opioid abuse and misuse, including
primary care providers (PCPs). Primary care providers are on the frontline in
managing patients’ pain, while screening for risks of opiate abuse and intervening
when addiction behaviors are suspected. Despite recent increases in pain
management specialists, primary care providers still manage most of the chronic
pain patients, estimated to be up to sixty percent of all pain patients (McCarberg,
2011). In 2009, forty-four percent of all opiate prescriptions originated from a
primary care provider (McCarberg, 2011). Given that PCPs generates a large
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number of prescriptions, some authors hold PCPs should play a significant role in
the development of policies and efforts to combat the problem (McHugh, Nielsen, &
Weiss, 2015). These providers face the challenge of effectively managing patients
with chronic pain, while simultaneously identifying those at risk for abuse or those
endeavoring to obtain the medications fraudulently (McDonald & Carlson, 2013).
Prescribers currently lack adequate education about how to identify those who are
misusing or diverting prescriptions provided under the guise of pain management.
The current state of the skills and knowledge in both these areas is reviewed below.
Educational Needs Of PCPs
Multiple studies and authors have identified a lack of training and knowledge
among PCPs in identifying and managing opiate addiction (Irvine et al., 2014;
McCarberg, 2011; Rutkow, Turner, Lucas, Hwang, & Alexander, 2015; Shepherd,
2014). Several barriers are cited as impacting the primary care provider’s ability to
decrease opioid abuse, including lack of education about misuse and diversion of
these medications to non-medical use (Webster, Brennan, Kwong, Levandowski, &
Gudin, 2015). McCarberg (2011) found only nineteen percent received training in
combating drug diversion and, in general, there was “poor” training in identifying
and treating abuse (McCarberg, 2011). In one survey only forty percent of surveyed
physicians received training in medical school for identifying drug abuse and
addiction (Manchikanti, 2007). Even a simple definition of what exactly constitutes
abuse and misuse is lacking as a large number of providers have an incomplete
understanding(Gilson & Kreis, 2009). Additionally, Manchikanti (2007) also cited a
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lack of understanding of the bio-physiology and pharmacology of opioid
medications.
Given these knowledge and skill deficiencies, recent efforts to combat opioid
abuse have included calls for improving training and education for providers. In
2007, federal legislation created the Risk Evaluation and Management Strategies
(REMS) for drugs with safety concerns. (Hahn, 2011). Part of the program aims to
provide education, training and certification for physicians (Hahn, 2011).
Additionally the National Institute on Drug Abuse has established Centers for
Excellence in Pain Education to facilitate provider education on these topics
(Compton, Boyle, & Wargo, 2015). Gaps in knowledge include lack of understanding
of the science behind use of opioids, importance of underlying psychosocial factors
in chronic pain patients and the role of non-pharmacological interventions for
chronic pain management (Manchikanti, 2007).
Educational efforts in medical training should also target the risk of
substance abuse issues among medical providers. There is currently little
educational time devoted to this unique risk. The circumstances of practice create a
unique ability to access opiates for personal use, and education around the risk of
this, as well as on how to identify abuse in colleagues, is critically needed but is
outside the scope of this paper (Dumitrascu, 2014).
In 2008, the Betty Ford Institute convened a panel to examine the needs for
education of providers in primary care (O'Connor, Nyquist, & McLellan, 2011).
From that panel came three recommendations to strengthen medical provider
training (O'Connor et al., 2011):
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
Integrate core competencies, such as is done for training for other
chronic medical conditions.

Prioritize substance abuse in training through integration of
“Screening, Brief Intervention and Referral to Treatment” (SBIRT)
training in residency.

Develop faculty mentors through faculty development programs.
Role of PCP in Identifying and Reducing Opioid Abuse and Misuse
Training is only effective if there are in fact markers and methods to identify
patients who are or have the potential to abuse opiates as new users. Studies have
shown certain characteristics of those at high risk for addiction, overdose, and
death. These include use of benzodiazepines or illicit substances, unemployment,
poor social supports, and psychiatric disorders, all of which are factors that are
often targeted in the public health programs (Agarin et al., 2015). Additionally,
screening tools are recommended that are easy to use and have good sensitivity and
specificity for potential or existence of abuse or misuse. Such tools include Opioid
Risk Tool (ORT)(Gudin, 2012); Screener and Opioid Assessment for Patients with
Pain Revised (SOAPP-R)(Gudin, 2012); Diagnosis, Intractability Risk, Efficacy
(DIRE); and Screening, Brief Intervention, Referral and Treatment (SBIRT) (Hahn,
2011). The ORT is a five item questionnaire designed to detect those at risk for
substance abuse (Gudin, 2012).
Screening instruments as mentioned above provide potential tools to use in
order to identify those engaged in, or at risk for, addiction and abuse. However,
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while some authors cite the effectiveness of these tools (Gudin, 2012), the reliability
of many of these screening tools are in question (Ballantyne, 2007; Dowell, 2016).
According to Seghal, Manchikanti, and Smith (2012), no tools have proven to be
well-tested, reliable and easily administered. A 2014 Agency for Healthcare
Research and Quality report cited four studies examining various tools all of which
produced inconsistent results. Additionally they found no studies that looked at the
effectiveness of these tools to change outcomes related to addiction (Chou, 2014).
SBIRT has recently been promoted by the Virginia Department of Health as a
resource for providers in addressing the opioid epidemic ("Substance Abuse
Screening," 2016). The SBIRT is supported by the Substance Abuse and Mental
Health Services Administration (SAMHSA), a department within the Department of
Health and Human Services.
SBIRT has proven efficacy in screening and treatment of alcohol abuse issues,
but the evidence of efficacy for opiate abuse is lacking (Agerwala & McCance-Katz,
2012). Despite this, SBIRT appears to be the most promising and adaptable
structured program for identifying and treating patients who abuse opioids. SBIRT
consists of three stages: screening, which can be done with self-administered
screening questions; a brief intervention, ranging from provision of advice to
several counseling sessions; and finally referral to treatment program if warranted
(Agerwala & McCance-Katz, 2012). Only accurate diagnoses of patients who have
chronic pain or addiction or both will allow efforts at rehabilitation. SAMHSA’s
development of SBIRT has included creation of demonstration sites, including
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several medical schools and residency programs, to improve education in substance
abuse issues (Seale, Shellenberger, & Clark, 2010).
One recommended approach to screening was set forth in a special issue of
the Pain Physician. Basic steps include: screening for individual risk factors using
available screening tools; incorporation of external sources of information such as
family members, medical records; and objective testing such as urine drug screening
to risk stratify (Seghal, Manchikanti, & Smith, 2012). “Universal precautions” is a
model built on infectious disease models for disease prevention. A ten step process,
this model includes the following (Seghal et al., 2012):

Establishing the diagnosis and possible comorbid mental illness and
risk of addiction

Obtaining informed consent for use of opiates

Designing treatment program

Assessing pain levels

Initiating a trial of opiates

Assessing pain relief, ability to do ADL’s, and addictive behaviors

Providing ongoing evaluation of diagnosis and treatment effect

Monitoring for compliance with treatment and development of
behaviors concerning for addiction
High-risk patients may require referral to pain specialists due to their high risk of
abuse. Such a referral may enable effective treatment of pain but is hampered by a
lack of such specialists nationwide (McCarberg, 2011).
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Recent studies show that less than ten percent of patients referred for
substance abuse treatment originate with a physician (Seale et al., 2010). One
survey of patients with substance abuse issues revealed that for fifty percent of
patients, the primary care provider did not address the substance abuse issue, and
from the primary care providers’ perspective, less then twenty percent felt “very
prepared” to address these issues (Polydorou, 2008).
Once initiated, treatment should be guided by ongoing monitoring of the
effect of medications, adherence to written contracts if utilized, and objective
screening for adherence to program through urine drug screening and monitoring
of the PDMP (Hahn, 2011; Seghal et al., 2012). Urine drug screening has potential to
be cost effective. While laboratory based testing is more specific and sensitive, point
of care testing in the office setting, with availability of a reference lab, may be
sufficiently accurate and cost effective to provide a useful tool to assess adherence
and the presence of other illicit drugs (Gudin, 2012).
Although these steps are effective, barriers to substance abuse screening and
treatment include lack of time in a busy office, low compensation levels for
screening efforts, lack of access to primary care and lack of community and referral
resources once a patient is identified as having a substance abuse issue (Seale et al.,
2010).
Even with appropriate training there is concern that the potential
requirement for time consuming mandated interventions or screening may
discourage PCPs from providing opiate pain medications, even for appropriate
patients, thus depriving patients of adequate pain management (Agarin et al., 2015).
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Ballantyne weighs the rights of patients to access pain management and privacy
related to this effort against the need for a comprehensive strategy to limit the
amount of these medications being prescribed and, therefore, available for abuse
and misuse (Ballantyne, 2007).
Public Health Approach And Challenges
The opiate addiction and overdose epidemic has its roots in many of the
issues facing public health. Much public health literature focuses on the social
determinants of health. Such factors as socioeconomic status, employment, social
supports and discrimination all can play a role in the development of addiction
behaviors (Galea & Vlahov, 2002). Literature demonstrates that adverse childhood
events increase the risks for substance abuse (Dube, 2003). Such events include, but
are not limited to, physical abuse, emotional abuse or neglect and living in
household with members who deal drugs or have mental illness (Dube, 2003).
The Social Ecological Model outlines levels of determinants from individual
factors and interdependent factors to broader community and societal influences
(Stone, 2012). Individual determinants, such as experience of abuse, represent the
first level of public health intervention. Targeted and population level interventions
to decrease rates of abuse may contribute to decreased subsequent involvement in
addiction behaviors for some individuals (Poole, Seal, & Taylor, 2014). Supportive
social relationships can play a role both in the prevention of development of
addiction behaviors, as well as improving outcomes in addiction treatment
(Scherbaum & Specka, 2008). One such approach is the Community Reinforcement
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Approach which focuses on changing environmental factors, something that can
only be done through collaboration between many stakeholders (Roozen et al.,
2004). The CRA method focuses on helping those with addiction modify their
community and social surroundings in order to encourage recovery from addiction
and prevent relapse. Originally designed for those with alcohol abuse issues, CRA
has been adopted by other substance abuse programs, including those dealing with
opiate addiction, with some evidence of efficacy(Abbott, 1998; Smith, Davis, Ureche,
& Dumas, 2016)
At the broader community and society levels, factors such as socioeconomic
status and availability of mental health and addiction treatment programs can
contribute to risks of, complications from, or recovery from addiction. A study in
New York City demonstrated a relationship between poverty and risk of death from
opioid overdose (Marzuk et al., 1997). One study demonstrated a clear increase in
rates of opiate abuse with increased rates of poverty and unemployment (Seghal et
al., 2012). Availability of treatment programs once addiction has occurred is crucial
to reduce complications from opioid abuse and give people a chance to make a
meaningful recovery. This is one area that primary care providers and public health
agencies may find significant synergies as one study showed people were more
likely to engage in a primary care based addiction treatment program (Barry,
Epstein, Fiellin, Fraenkel, & Busch, 2016).
One example of a synergistic partnership between medical providers and
public health organizations can be seen in Rhode Island. Officials there have been
making efforts at coordinating public health resources with medical practitioners to
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combat their opiate problems (Lewis, 2014). Programs have included communitybased programs that provide and train lay people in the use of Naloxone that can
reverse the lethal effects of opiate overdose. In coordination with this, educational
efforts aimed at the general public were undertaken to teach people about the risks
of abuse and overdose (Bowman, 2014). Additionally, there have been efforts to
educate providers in the usage of the PDMP (Green, 2014). However despite these
efforts, officials in Rhode Island acknowledge there is still insufficient resources for
substance abuse treatment and rehabilitation (Lewis, 2014). Another collaboration
in Rhode Island between law enforcement and public health has created “disposal
units” which provide a location for unused prescriptions to be turned in and
destroyed (Bowman, 2014). Other efforts utilizing public health organizations,
community and private partnerships, have included widespread educational
outreach to the public, as well as development of more robust and accessible
substance abuse treatment programs (Bowman, 2014).
In North Carolina, a coalition has created Project Lazarus a group that has
developed a model to reduce opiate abuse and overdose. The five components of the
program are as follows (Albert et al., 2011):

Community activation and coalition building

Monitoring and surveillance data

Prevention of overdoses

Use of rescue medications to reverse overdoses

Evaluation of project components
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The central tenet of the project is that each community is ultimately responsible for
their own health and active participation by many stakeholders is required (Albert
et al., 2011). Opiate abuse presents a major public health challenge that spans the
life spectrum and requires interventions beginning in childhood that provide
primary prevention through adulthood with collaborations with the medical
community to provide risk reduction and addiction treatment. Such efforts could
involve public health organizations and health care providers developing joint
educational programs aimed at improving parenting skills and how to identify high
risk factors such as physical or emotional abuse (Dube, 2003). Such efforts may
include PCPs making referrals to community support programs that teach parenting
and other coping skills. Such efforts can potentially reduce children’s exposure to
adverse childhood events.
Design and Management of Prescription Drug Monitoring Programs
Prescription drug monitoring programs (PDMP’s) are electronic databases
that track all prescriptions filled by pharmacies. The Controlled Substance Act of
1970 utilized only paper based tracking systems. The electronic tracking system
first started in 2003 (Worley, 2012) with financial support provided to the states by
the federal government (Finklea K, 2014). Since adoption by the first states, the
program has grown to forty-nine states, each database being run by the individual
states (Agarin et al., 2015; Rutkow et al., 2015)
The design, establishment and operations of the databases are entirely
determined by the individual states (Finklea K, 2014). This includes the type of
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information that is reported, who is required to submit information, who can access
the database, and which medications are monitored (Finklea K, 2014; Rutkow et al.,
2015) For most databases, the information on prescriptions is collected by
pharmacies and entered into the database and most often includes patient name,
drug prescribed, quantity dispensed, prescriber’s name and location where
prescription is filled (Rutkow et al., 2015). Costs to establish and operate databases
are substantial, ranging from $450,000 to $1,000,000 to establish and between
$125,000 and $1,000,000 annually to operate (Finklea K, 2014). These costs fall
mostly upon the states, although several federal grants exist to help defray the costs.
(Finklea K, 2014)
Some states have proactive databases that alert prescribers or pharmacists
to potential abuse situations. The proactive databases have been shown to be more
effective then those without active alerts (Worley, 2012). However, most states rely
on the provider logging into the system and looking up the patient to gather
prescribing history. Few states have laws that mandate database usage. Tennessee
requires doctors to utilize the PDMP and report doctor shopping to law enforcement
(Worley, 2012). Some states simply mandate registering to use the system, where
other states require looking up prescribing histories under certain circumstances
(Worley, 2012). Legislative mandates have become more common due to low
voluntary usage of the databases by providers with one study showing an average of
fifty-three percent of providers using the program (Irvine et al., 2014).
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Effect of PDMP’s on Opioid Diversion
Some early studies show potential effectiveness of PDMP’s in decreasing
doctor shopping and altering prescribing patterns (Delcher, Wagenaar, Goldberger,
Cook, & Maldonado-Molina, 2015; Finklea K, 2014). The concern that prescribers
will fail to adequately manage pain was not supported in a North Carolina study.
From 2009-2011, there was no correlation between increased usage of the PMDP
and reduction in rates of opiate prescribing(Ringwalt et al., 2015). In fact, the study
also noted a plateau in rates of opiate related deaths starting in 2008 suggesting
increased use of PDMP may play a role (Ringwalt et al., 2015). In 2011, one study in
Florida showed a 25% reduction in oxycodone-related deaths, even after controlling
for other interventions implemented at the same time (Delcher et al., 2015). There
was a correlating decrease in rates of opiate prescriptions in the same time period
with increased rates of accessing the PDMP.
A Pew Research Report concluded there was sufficient evidence of
effectiveness to recommend widespread adoption of PDMP’s (Clark, 2012). Their
conclusion was that use of PDMP best practices brings together the goals of effective
medical care, prevention of opiate abuse and diversion and substance abuse
treatment. PDMP was described as critical to combating the epidemic (Clark, 2012).
In 2012 the White House ordered the Office of National Drug Control Policy to
integrate state PDMP’s into a comprehensive strategy to combat prescription drug
abuse and diversion (Finklea K, 2014).
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Challenges in Use of PDMP’s
Despite this push to integrate PDMP’s into combating opioid abuse, there are
still some concerns regarding its usage. Resistance to usage of the PDMP arises from
several factors. Time required to utilize the database, lack of interoperability with
electronic medical records and poor report formatting have been cited as barriers
by providers (Rutkow et al., 2015). Additionally, questions of data accuracy and the
lack of complete information continue to be challenges in the creation of these
databases (Griggs, Weiner, & Feldman, 2015). In some cases, such as residency
clinics, a shared DEA number obscures the ability to identify different prescribers
(Griggs et al., 2015). Timing of when data is entered into the database also limits the
effectiveness of the database with lack of real-time data entry compromising the
usefulness (Gudoski, 2015).
Early on the lack of interstate data sharing hampered effectiveness of the
databases (Griggs et al., 2015; Gudoski, 2015). Recent technological advances have
improved interstate sharing of information, but incomplete sharing still creates
barriers. The National Alliance for Model State Drug Laws, in their 2015 proposal,
identifies lack of coordinated efforts as a major barrier (President's Commission,
2015). In an effort to address this, The Bureau of Justice Assistance PDMP program
has created an open architecture information exchange that protects the needs of
individual state regulatory requirements, while facilitating easy and accurate
sharing of information between registries (Bureau of Justice, 2014)
There is some debate over the role of the federal government versus state
run PDMP’s, with some calling for a federal database (Gudoski, 2015). Technical
23
limitations, as well as legal restrictions, present a challenge to integrating access to
the PDMP’s for providers in busy clinical practices (Gudoski, 2015). In some states
without mandated usage, a minority of providers regularly access the PDMP (Green,
2014). In some states database reports cannot be incorporated into electronic
health records, either due to legal restrictions or technical limitations, although
there are ongoing efforts in many states to address these obstacles (Gudoski, 2015)
(Rutkow et al., 2015).
Some fear that mandated usage will lead PCPs to stop prescribing opioid
medications out of fear of punitive measures or due to administrative burden
required under mandated usage. (Haffajee, Jena, & Weiner, 2015). Others fear a loss
of patient privacy and access to adequate pain control measures (Gugelmann,
Perrone, & Nelson, 2012).
Despite these challenges, PDMP’s are believed to be a key aspect in
combating prescription drug abuse. The PEW Report calls it an “underutilized”
resource and calls for standardization of data collection and development of
interstate operability (Clark, 2012). Additionally, the Justice Department has
supported A Prescription Drug Monitoring Program Center of Excellence at Brandeis
University to provide analytical support, encourage innovative uses and identify
best practices for PDMP’s (Deyo et al., 2013). In 2009, the Department of Health and
Human Services provided additional funding to states in support of the PDMP’s
(Deyo et al., 2013).
24
Best practices for usage of PDMP’s have been outlined in the PEW report.
“Candidate practices” have been identified, and current efforts at developing PDMP’s
should incorporate the following items (Clark, 2012):

Standardized data collection, including what drugs are reported and how
patients are identified

Real time data collection

Usage of serialized prescription forms with integration of electronic
prescriptions into the PDMP’s
Integrating PCPs, Public Health Agencies and PDMP’s
While widely prescribed for chronic non-cancer pain, there is debate over the
efficacy of opioids for such pain (Eriksen, Sjøgren, Bruera, Ekholm, & Rasmussen,
2006). A comprehensive review of the literature is outside the scope of this paper
but one such review is American Pain Society’s Guideline for the Use of Chronic
Opioid Therapy in Chronic Non Cancer Pain (American Pain Society, 2015). The
review showed that high level evidence is lacking and reliability on expert opinion is
the cornerstone of practice in this area (Burgess, 2014). A recent report by the
Centers for Disease Control provides strengthened guidelines that recommend the
use of non-opiate interventions and usage of opiates only in specific cases of noncancer pain (Dowell, 2016). Given this controversy, the need for education of
providers in comprehensive pain management, including non-pharmacological
interventions, becomes all the more important. This comprehensive approach
reduces the reliance on opioid prescriptions as the only component of pain
25
management. Despite this recent shift in focus, opiate use and addiction will
continue to be a critical issue requiring collaborative approaches.
In a 2012 commentary, Alexander, Kruszewskia and Webster acknowledge
that enforcement must be complemented by changes in clinical protocols and a
public health approach to pain treatment and addiction (Alexander, Kruszewski, &
Webster, 2012). Any model must target primary prevention to prevent development
of addiction, secondary prevention through identifying early misuse or addiction
behaviors and tertiary prevention by providing effective addiction treatment
programs(Kolodny et al., 2015). One such model is the Lazarus project, which has
developed community partnerships to address this epidemic through strong
collaborative models between PCPs, public health entities and technological tools
such as the PDMP (Albert et al., 2011).
Training of Providers
There remain several challenges that must be met if these collaborative
efforts are to be successful. First, there must be development of and requirement for
education and training for primary care providers, starting in medical school and
carried on through residency. There has been a call for mandated, minimum hour
standardized training by some authors (Manchikanti, 2007). Although this is a
necessary starting point, continuing education opportunities for currently practicing
providers is needed. Mandated yet easily accessible and time efficient training tied
to maintenance of an active DEA license would ensure all providers writing for
controlled substances have adequate training. Effective training focuses on
26
identifying those at risk for suffering from abuse and misuse, as well as recognizing
methods used by patients to divert prescriptions to family, friends and strangers for
financial gain. Finally, PCPs must be trained to effectively and compassionately
confront patients who may be abusing medications. This is best done in a nonaccusatory fashion that facilitates referral to treatment programs. Additionally,
there must be investment in substance abuse treatment programs to which these
patients can be referred.
Effective Usage of PDMP’s
PDMP’s are increasingly integral to comprehensive efforts to combat the
opioid epidemic. As such, issues related to accuracy, accessibility and ease of use of
the PDMP’s must be resolved if there is to be widespread adoption of regular usage
of the databases. Primary care providers generally have high volume clinics with
little extra time available for logging into a web database and incorporating that
information into the electronic record. The Pew Report calls for interoperability
with electronic medical records such that the creation of a electronic controlled
substance prescription will automatically generate a report of that patient’s
prescribing history (Clark, 2012). Despite efforts to decrease the burden of use,
mandated usage has been fought at the medical industry level with the AMA
lobbying for legislation to protect providers who do not access the databases on the
basis of duty to treat pain (Gudoski, 2015).
The Pew Report calls for interoperability between the state databases and
electronic medical records and electronic prescribing systems, as well as interstate
27
information exchange (Clark, 2012). Such integration will improve timeliness,
accuracy and usability of the databases (Clark, 2012). States are also moving to webbased access to the databases that increase ease of access (Clark, 2012). Efforts to
achieve best practices as outlined in the Pew Report are critical to ensure
effectiveness of the usage of the databases, as delayed or inaccurate data will render
the PDMP’s unreliable and, therefore, less effective in the fight against opioid abuse.
Involving providers in the decision about legislation and mandates of usage
of the PDMP is essential to the PDMP being an effective tool. Concerns over impact
on patient care must be addressed. In the state of Virginia, the patient must be
informed that the database has been accessed, although permission is not required.
This can create a barrier of mistrust between providers and patients who are
appropriately utilizing their prescriptions (Gugelmann et al., 2012). Many fear that
providers will simply stop providing prescriptions for pain medications out of fear
of increased scrutiny. However one study in North Carolina did not find this to be
true (Ringwalt et al., 2015). Educational outreach to providers may help to address
these concerns and improve usage rates of the databases (Gudoski, 2015). Finally
ongoing research into the effectiveness of the PDMP’s and identification of best
practices is essential to ensure the time and money invested in these programs are
being effectively spent and actually reducing opioid diversion and abuse (Haegerich,
Paulozzi, Manns, & Jones, 2014).
28
Public Health Interests
Significant overlap between the factors contributing to the epidemic of
opioid abuse and diversion and community factors that are the focus of public
health exists. Public health challenges such as poverty, child neglect and abuse, and
unemployment are all risk factors for addiction and overdose (Seghal et al., 2012).
Ongoing coordinated efforts between government, non-profit and the private sector
will help reduce or eliminate these contributing factors. Additionally, community
based resources and programs for substance abuse treatment and rehabilitation, as
well as collaborative models with primary care providers, are necessary to provide
relief to those suffering from substance abuse and addiction (Roozen et al., 2004). In
keeping with an effective and ethical public health interventions, fair allocation of
resources, use up-to-date information and modern scientific approaches, are best
built on community partnerships and helps to avoid waste and duplication (Kass,
2001)
Financial Incentives
Financial supports for all three aspects of the collaborative model are critical
to success. PCPs ask for fair payment, public health programs need money for
programmatic support and state governments require financial resources for
operations of the PDMP.
In the current climate of focus on quality and value in healthcare,
development of pay for performance or cost savings sharing may effectively
incentivize primary care providers to be part of the solution. Otherwise, the risk is
29
many will simply stop providing pain management for patients, a move that will
only serve to degrade the quality of pain management in the healthcare system.
There are limited studies on using financial incentives, such as lower malpractice
rates, but such programs should be undertaken in pilot projects to assess
effectiveness (Clark, 2012)
The shifting landscape of healthcare towards population health and
Accountable Care Organizations creates financial incentives to develop effective
substance abuse treatment programs to control healthcare costs. Such programs
will benefit from public health, community resource, and private industry
collaborations. Substance abuse treatment involves not only medical therapies but
also psychosocial interventions(Roozen et al., 2004). Virginia has recently
strengthened funding for treatment of substance abuse through Medicaid including
payment for community based treatment programs (VIrginia Department of
Behavioral Health, 2016).
The Obama administration has tasked federal agencies that provide payment
or facilitation of medication-assisted treatment for opioid abuse with decreasing
barriers to these services (Whitehouse, 2015). The Betty Ford Center has called for
studies identifying best practices for recovery support services to improve
treatment and community resources for addiction (White, 2012). Such efforts must
include financial resources to support provider, community and patient efforts at
substance abuse treatment.
30
Recommendations For A Collaborative Approach
Based on the above literature analysis, the following recommendations for
interventions are as follows:

Improve educational programs for medical students, residents, and
established providers.
o At least 20 hours both in medical school and residency, each
working with addiction and chronic pain patients as well as
didactic information about the pathophysiology of pain and
opiates, should be provided.
o Education for providers in active practice should include best
practices in pain management, how to screen for risk of opiate
abuse, and interventions to treat addiction.

Development of clinical protocols using suitable screening tools such
as SBIRT to identify those with chronic pain and risk of addiction or
who are currently addicted.
o Incorporating screening tools with urine drug testing and
review of the PDMP will maximize the ability to correctly
identify people engaged in abuse or diversion.

Perform ongoing assessment and real time training for providers
implementing the clinical protocols to ensure the program is effective
and appropriately being utilized.

Develop greater technological capacity of the PDMP’s.
31
o Includes creating comprehensive interstate sharing of
information as well as improved interoperability with
providers’ electronic medical records.
o Ease of accessing and the ability to incorporate the report into
the electronic medical record is essential for widespread
adoption. The primary usage of the PDMP by PCPs should be to
use this information to refer patients to services for addiction.

Enhance community resources to address the underlying socioeconomic risks for abuse such as poverty and abuse.
o
Supporting and building programs that elevate the socioeconomic level of communities and actively engage the
community in issues of public health.

Build public health programs that support development of community
addiction and mental health services in coordination with primarycare providers, creating a shared model of medical and behavioral
addiction treatment.
Conclusions
As the statistics illustrate, rates of abuse and misuse with resulting increase
in overdoses and deaths have been on the rise over the last decades. It has truly
reached epidemic proportions. With nearly every state now having an existing
Prescription Drug Monitoring Databases, the tools to begin addressing this problem
exist. However, there is an imperative to including primary care providers in the
32
decision-making and policy design surrounding usage of the PDMPs. In order to
facilitate such participation, primary care providers should receive effective and
recurrent education on pain management, use of opiate medications, and
identification of addiction behaviors. Educational efforts combined with inclusion in
policy decision- making will go a long way towards assuring a buy-in by the primary
care community and give them a sense of ownership over the collaborative effort to
decrease rates of opiate abuse, misuse, overdoses, and death in the United States.
Education efforts for providers coupled with improving accuracy, timeliness, and
accessibility of the PDMP’s are absolutely necessary to decrease diversion and
inappropriate usage of opioids. Integration with existing public health programs
aimed at reducing socioeconomic inequality and other risks of substance abuse, as
well as community based recovery programs is critical. With the annual rate of
increase of overdoses and deaths, time is of the essence in moving forward with
these efforts.
33
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