The utilization of opioid medications in the treatment of pain and the associated potential for diversion and misuse of these medications has risen 160% in our country in the last 10 years. In North Carolina, this is reflected in the deaths of 11.4 persons per 100,000 citizens annually, ranking the state as the 22nd in the country in deaths by unintentional poisonings. The majority of these deaths were linked to prescription opioids, with a significant decrease in the last decade in deaths related to heroin and cocaine. The Centers for Disease Control and White House's Office of National Drug Control Policy have declared prescription drug overdose deaths an “epidemic”.1 

This problem is reflected in our hospital emergency departments (increased utilization by patients often seeking prescriptions for opioids), our primary care practices (increased numbers of prescriptions for and doses of opioids written), and in our communities where the sequelae of misadventuring with opioids crosses all socio-economic strata. Further, emerging evidence suggests that many chronic pain conditions, such as degenerative joint disease, bulging discs, and other chronic low back or musculoskeletal problems may be more effectively and safely addressed with non-opioid pharmacotherapy combined with physical therapy, occupational therapy, chiropractic, acupuncture, weight reduction (obesity is a major contributing factor to many back and joint pain syndromes), meditative practices, cognitive behavioral therapy (CBT), specifically focused on re-framing and changing world perspective of living with pain, treating underlying mental health illness, teaching coping strategies, proper nutrition, and improved sleep hygiene.2–5 Treatment of chronic pain in patients with multiple medical comorbidities is a clinical challenge, and many, if not most, providers have not been adequately trained in this arena. Therefore, the identification and subsequent addressing of training needs of clinicians (potentially via a variety of mechanisms) in the best practices management of chronic pain has been identified as a critical area.6–9 

The Chronic Pain Initiative (CPI) led by Community Care of North Carolina (CCNC) is patterned after a successful pilot project conducted in Wilkes County, N.C. via Project Lazarus.10,11 The Wilkes experience highlighted the fact that public health problems related to prescription opioids are so tightly intertwined with pain management issues that they must be addressed concurrently. The Wilkes Project was a single county initiative with the goal to address the myriad issues involved in the treatment of chronic pain and opioid safety, supported through the combined efforts of the local CCNC Network, Project Lazarus, and with local participation of hospitals, providers, education, law enforcement, and public health. CCNC has recently obtained a $1.2 million Kate B. Reynolds Trust grant with matching funds provided by the North Carolina Office of Rural Health. This funding will enable the project to be expanded statewide in 2013.

The three major components of the CPI are community engagement, clinical elements, and outcomes assessment. The community engagement around the problem is important to align local resources and to assist the local community in recognizing that the issue exists in their community. Secondly, the clinical elements, those described in the CPI Tool Kits developed for emergency departments and primary care practices, are designed to align these providers with the pharmacist community around the issues and accompanying training regarding safer opioid prescribing training/physician mentoring provided by the Governor's Institute on Substance Abuse, and the CCNC network care management component for patients. Third, the outcome measures are being determined and measured by UNC Injury Prevention and Research Center (IPRC) to enable assessment of project impact in each community. These three components make this initiative unique in that it addresses not just the complex clinical issues in the prescribing of opioid medications, but also the need for the community to be actively engaged around addressing a clinical and community-based public health problem. One of the key aspects of the clinical training is increasing use of the North Carolina prescription drug monitoring system (referred to locally as the Controlled Substance Reporting System or CSRS).

This statewide prescription drug management program (PDMP) was established by North Carolina law in 2005 to improve the state's ability to identify people who abuse, misuse, and potentially divert prescription drugs classified as Schedule II–V controlled substances.12 It is also meant to assist clinicians in identifying and referring for treatment patients misusing controlled substances. The NC Division of Mental Health, Developmental Disabilities and Substance Abuse Services makes rules and manages the program. The PDMP is referred to in North Carolina as the CSRS (Controlled Substance Reporting System) and is essentially an electronic database which collects designated data on substances dispensed in the state. The CSRS is housed by a specified statewide regulatory agency, and this agency distributes data from the database to individuals who are authorized under state law to receive the information for purposes of their profession. The federal Drug Enforcement Administration (DEA) is not involved in state level prescription drug monitoring programs. According to the Alliance of States with Prescription Drug Monitoring Programs, currently 49 states and one territory have legislation authorizing the creation and operation of a PDMP. Forty-two States currently have a PDMP that is operational (meaning collecting data from dispensers and reporting information from the database to authorized users). For more information, the Alliance website allows viewing of the PDMP Program Status Map or PDMP Program Status Table; to learn more about a specific state PDMP, refer to the PDMP website “State Profiles” section.13 

The North Carolina CSRS program's stated goals are to:12 

  • Identify and prevent diversion of prescribed controlled substances

  • Reduce morbidity and mortality from unintentional drug overdoses

  • Reduce the costs associated with the misuse and abuse of controlled substances

  • Assist clinicians in identifying and referring for treatment patients misusing controlled substances

  • Reduce the cost for law enforcement of investigating cases of diversion and misuse

  • Inform the public, including health care professionals, of the use and abuse trends related to prescription drugs

As this program is governed by state statute, any changes in rules or administration of the registry require legislative approval. Such oversight, while well-intended, often impedes flexibility of the registry to meet the needs of a rapidly changing healthcare landscape.

CCNC has an existing infrastructure across the state that consists of 14 Networks with over 1500 primary care practices including over 5000 primary care providers and over 600 care managers.14 This infrastructure has supported the chronic disease management programs that have been a successful part of CCNC for many years. In the last three years, an Integrated Care model has been added which includes 14 Behavioral Health Coordinators and part-time psychiatrists located in each Network. Each of the 14 Networks has designated a Chronic Pain Initiative Coordinator to serve as the CPI champion and to act as a facilitator and “train the trainer” in each Network. Other tasks include working with emergency departments around policy changes and in the use of Provider Portal and CSRS, to lead individualized practice visits with PCPs around specific chronic pain cases utilizing the PCP toolkit as a starting point, to serve as a community liaison for the community aspect of the CPI program, to develop county resource lists for pain management and substance abuse services, and in some instances to provide care management for patients identified through the chronic pain initiative.

CCNC, via the Chronic Pain Initiative, has the goal of engaging healthcare professionals and communities to take steps to stem this rising tide of opioid overdose deaths. Communities have recognized the need to take action to make inroads into this public health problem and are presently aligning local coalitions to take steps to make a difference. CCNC is challenging pharmacists to become active participants in these local discussions, as this is a critical patient and community safety issue around safe medication use, as well as an area where pharmacists have considerable potential impact. This is a critical clinical opportunity for pharmacy in a highly visible arena. CCNC believes that broad, definitive actions must occur to begin to curb behaviors that feed into the problem of unsafe, and at times inappropriate, prescribing by providers and subsequent use and potential abuse of opioids by patients. Given that pharmacists are highly visible and community-focused professionals, and that most prescription opioids initially enter the supply chain via the pharmacist dispensing route, CCNC believes proactive pharmacist engagement is critical to beginning to successfully address the issue of improving appropriate use of these drugs.10 

CCNC is reaching out to pharmacists via the North Carolina Board of Pharmacy and the NC Association of Pharmacists (NCAP) to educate and elevate the issue of improved safety around opioid use and to demonstrate how to become involved locally. Initial steps include increasing awareness of and use of the CSRS for certain “high risk” situations that may indicate misuse or misadventuring, communicating with healthcare providers in the community regarding identified “at risk” practices and patients, assisting with organizing local medication take back days, as well as maintaining fidelity of the North Carolina Division of Medical Assistance Recipient Lock-in program.15 Additionally, pharmacists are exceptionally accessible healthcare providers and are in a position to educate patients and their families regarding medication safety and security within the home to minimize unintended access and use of dangerous medications. Chronic pain management and opioid prescribing is currently a hot button issue; numerous clinicians, pharmacists, and health departments are actively seeking help with the problem in their own communities. The demand by clinicians and communities for assistance with management of this problem grows daily.

This comprehensive approach will hopefully reduce confusion and increase synergy around this public health problem. Presently, there is clinician overload and confusion on the part of both physicians and pharmacists because of numerous, seemingly unrelated initiatives, coalitions, and free-standing trainings that address safer opioid prescribing and chronic pain management. The CPI essentially will seek to solve this problem by developing a highly visible comprehensive statewide infrastructure, utilizing an inclusive approach so individual groups and communities do not need to develop programs of their own.

A coalition of members of CCNC, North Carolina clinical professional associations, and other health advocacy organizations recommended that steps be taken to strengthen the CSRS in North Carolina. The CSRS began operation in NC in 2007. The system requires pharmacists to report into the system any time a controlled substance is dispensed, irrespective of payment source. Prescribers of medications, including controlled substances, may check a patient's controlled substance prescription history before prescribing; however, only about one-third do so. Currently, information in the CSRS is updated every seven days, using pharmacy provided data. Users must complete and submit an application; after review and approval users then may access the information using a secure log-in and password.12 This coalition has worked with a legislative task force (North Carolina Harm Reduction Task Force) to introduce legislation in this session to strengthen the CSRS and to encourage clinician use. It is believed that improved use of the information in this registry will improve safer prescribing of opioids and other controlled substances.

As previously mentioned, the CSRS exists due to North Carolina statute and rules governing the operation of the registry can be modified only via legislative action. The coalition has put together a set of proposed legislative actions intended to improve use of the CSRS and increase the information feeding into and out of the CSRS. This proposal became Senate Bill 222 and House Bill 173. As only about one-third of DEA licensed providers and a similar proportion of registered pharmacists are approved to access information in the CSRS, the coalition has suggested that it must be made easier for prescribers and pharmacists to use the CSRS. One of the key reasons reported as to why providers do not use the CSRS more is that they do not have time. Under current law, only providers and pharmacists (prescribers and dispensers) may look up information in the CSRS. The current legislative proposal would allow prescribers to assign a delegate user (such as a nurse) who could then, in turn, look up information before a prescription was written. The provider and the delegate would have distinct but linked identifier numbers so that the CSRS could determine who sought information. The proposal also provides that CSRS can screen delegates for suitability. To build in additional assurance that the registry is not accessed for unintended (i.e., non-clinical purposes), the proposal doubles the fine for misuse of the CSRS from $5,000 to $10,000.

Another action would make it mandatory for providers or delegates to report physician's office dispensed medications. This measure would require that a provider report into the CSRS when dispensing more than two days of controlled substances. Currently, providers are not required to report into the CSRS when they dispense a medication. Therefore, there is no record of this controlled substance being out in the community. While dispensing of controlled substances by doctors is presently rare in this state, it is an important preventive measure to deter “pill mills” in the future.

Currently, the CSRS may only report patterns of concern directly to the State Attorney General. Patient or provider use may, in fact, be concerning prior to and without rising to a level that is potentially criminal in nature. This proposed measure would direct the Department of Health and Human Services (via an existing multi-disciplinary advisory panel) to make rules about when to contact the primary provider on record about a patient having either an unusual number of controlled substance prescriptions filled or visiting multiple pharmacies or providers, in order to let that provider of record determine if the pattern is concerning. The measure also directs the Department to work with providers and other professionals to establish rules to determine when the Medical Board should be contacted about concerning prescribing patterns by a provider. The provision is permissive in that it does not require that CSRS, the provider, or the Medical Board to take action but allows them to act when concerned, giving them clinical latitude when judged to be appropriate and necessary.

Lastly, the proposal requires a decreasing of the reporting time from the current seven days to daily. Having more current information would allow for better treatment in an overdose situation, such as in an emergency department. This proposal was subsequently modified to reporting at intervals no more than every 3 days. For patients obtaining controlled substances via daily or more frequent emergency room visits, this increased frequency of reporting is important.

In order to obtain support for these proposed measures, and to improve clinician use of the CSRS, CCNC clinical staff have lobbied various North Carolina clinical professional associations, state clinical licensing boards, media, and key legislators regarding the background of the opioid safety issue and the rationale for the legislation as an attempt to mitigate the opioid misadventuring and associated unintentional deaths.

CCNC believes that making enduring changes in clinical practice is challenging, but possible. Physician opioid prescribing and patient expectations around what constitutes appropriate management of chronic pain can be successfully modified. Success will be facilitated by making necessary adaptations to the practice setting/health system and providing ongoing supports so that the new behavior can be sustained. Improving the CSRS registry and improving provider access to this valuable information is critical to the overall success of the program. CCNC and its CPI partners believe this is a challenge that must be met for the public health of North Carolina's citizens.

Post-script: HB 173/SB 222 passed and were signed into law by Governor McCrory 6/19/2013.

1.
CDC grand rounds: prescription drug overdoses - a U.S. epidemic
.
MMWR Morb Mortal Wkly Rep
.
2012
;
61
(
1
):
10
3
.
PubMed PMID: 22237030
.
2.
Svenson
JE
,
Meyer
TD.
Effectiveness of nonnarcotic protocol for the treatment of acute exacerbations of chronic nonmalignant pain
.
Am J Emerg Med
.
2007
;
25
(
4
):
445
9
. .
3.
Schug
SA
,
Manopas
A.
Update on the role of non-opioids for postoperative pain treatment
.
Best Pract Res Clin Anaesthesiol
.
2007
;
21
(
1
):
15
30
.
PubMed PMID: 17489217
.
4.
Munir
MA
,
Enany
N
,
Zhang
J-M.
Nonopioid analgesics
.
Anesthesiol Clin
.
2007
;
25
(
4
):
761
74
,
vi
. .
5.
White
PF.
The Changing Role of Non-Opioid Analgesic Techniques in the Management of Postoperative Pain
.
Anesth Analg
.
2005
;
101
(
Supplement
):
S5
S22
. .
6.
Chen
L
,
Houghton
M
,
Seefeld
L
,
Malarick
C
,
Mao
J.
Opioid therapy for chronic pain: physicians' attitude and current practice patterns
.
J Opioid Manag
.
2011
;
7
(
4
):
267
76
.
PubMed PMID: 21957826
.
7.
Chiauzzi
E
,
Trudeau
KJ
,
Zacharoff
K
,
Bond
K.
Identifying primary care skills and competencies in opioid risk management
.
J Contin Educ Health Prof
.
2011
;
31
(
4
):
231
40
.
DOI: 10.1002/chp.20135. PubMed PMID: 22189986
.
8.
Cohen
SJ
,
Halvorson
HW
,
Gosselink
CA.
Changing physician behavior to improve disease prevention
.
Prev Med
.
1994
;
23
(
3
):
284
91
.
DOI: 10.1006/pmed.1994.1040. PubMed PMID: 8078848
.
9.
Trowbridge
R
and
Weingarten
S.
Agency for Healthcare Research and Quality. Educational Techniques Used in Changing Provider Behavior
. .
10.
Community Care of North Carolina
.
Chronic Pain Initiative
. .
11.
Project Lazarus Model
. .
12.
North Carolina Division of Health and Human Services
.
Controlled Substance Reporting System
. .
13.
Alliance of States with Prescription Drug Monitoring Programs
.
http://www.pmpalliance.org/. Accessed 6/10/2013
.
14.
Overview of Community Care of North Carolina
.
16.
CCNC's Chronic Pain Initiative Seeks to Educate and Engage Pharmacists to Prevent Overdose Deaths Attributable to Opioid Misuse
.
North Carolina Board of Pharmacy Newsletter October 2012. Pages 1,4. http://www.ncbop.org/Newsletters/Oct2012.pdf. Accessed 6/10/2013
.