Presented to the 2015 FLANP Annual Meeting
August 8, 2015
Alicia Craig-Rodriguez, DNP-c, MBA, BSN, RN
Florida State University
Cynthia Drew, MSN, ARNP
1.
Demonstrate understanding of opioid medication
management/prescribing
2.
Describe brief history of opioid prescribing in Florida and
the state's current monitoring requirements for opioid
prescribing
3.
Describe core competency requirements to ensure safe
and effective prescribing of opioids in clinical practice
4.
Discuss next steps and available continuing educational
options that fulfill criteria for FDA OPIOID REMS for
extended release and long acting opioids
1.
Pharmacokinetics and pharmacodynamics of
opioid medications.
2.
Core competencies needed to ensure safe and
effective prescribing of opioids
3.
Results of Florida Needs Assessment Survey on
Nurse Practitioner readiness for future opioid
prescribing and its implications for advanced
nursing practice
Drug Enforcement Administration (2015). Retrieved from http://www.dea.gov/druginfo/ds.shtml
"Florida is on the verge of recovering from a
massive statewide pill-mill crisis. Yet now, the
Florida House is considering a bill that would
unleash thousands of new practitioners into our
communities with prescription pads poised to
prescribe narcotics."
- Alan Harmon, FMA President (2014)

Also known as narcotics, any drug, natural or synthetic,
that has actions similar to its prototype, morphine

Mechanism of action: attach to specific opioid
receptors, and mimic the actions of endogenous
peptides, primarily at mu receptors

Pharmacologic actions: reduced perception of pain,
increased sense of well-being/euphoria, anxiety
reduction

Common adverse effects include sedation, confusion,
hypotension, constipation and respiratory depression,
tolerance and physical dependence
Lehne & Rosenthal (2014)

Tolerance: a state in which a larger dose is
required to produce the same response

Physical Dependence: a state in which an
abstinence syndrome will occur if opioid
use is abruptly stopped

Abuse: drug use that is inconsistent with
medical/social norms
Fishman, 2012; Lehne & Rosenthal, 2014; Webster & Dove, 2007.

Misuse: use of any drug in a manner other
than how it was prescribed

Addiction: characterized by continued use
of a psychoactive substance despite
physical, physiologic or social harm

Abuse Liability: a drug’s propensity to be
abused, producing adverse public health
consequences
Fishman, 2012; Lehne & Rosenthal, 2014; Webster & Dove, 2007.
Misuse 40%
Abuse: 20%
Addiction: 2% to 5%
Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.
Total Pain
Population
Serious Gaps in Prescriber Knowledge, Attitudes
and Beliefs (MDs and ARNPs)
 Lack of standardized training
 Lack of Consensus of Pain Treatment Guidelines for
chronic, non-cancer pain


Opioids are the most prescribed class of
medications in the United States (>90% of
world’s total); yet many practitioners
(including MDs) feel inadequately
prepared/trained to prescribe

Currently, 49 states and DC allow Nurse
Practitioners to prescribe DEA controlled
substances (in accordance with state
laws)
National Institute on Drug Abuse, 2014. Retrieved from http://www.drugabuse.gov/about-nida/legislative-activities/testimony-tocongress/2014/americas-addiction-to-opioids-heroin-prescription-drug-abuse#_ftn5
Total number of prescriptions dispensed in the U.S. by various specialties for IR and
ER/ LA opioids, year 2009.
American Society of Interventional Pain Physicians (2012).
“OxyExpress”
1,000 pain clinics
$1m oxycodone pills sold
monthly
90+ of the top 100 MDs
purchasing oxycodone in
the U.S. practiced in Florida
($650m pills shipped)
Drug Enforcement Administration (2010-2012)
• E-FORCSE PDMP
initiated 2011
• Dispensers of controlled
substances must report
transactions within 7
days
• Provides real-time
access
• Oxy Prescriptions fell by
24%
• Deaths fell by 52%

Approximately 3.8 million patients, annually
receive ER/LA opioids in the OP setting

~ ½ of ER/LA opioids are prescribed by PCPs,
usually for chronic pain conditions

Risk Mitigation & Evaluation Strategy (REMS)
launched in 2012 to reduce serious outcomes while
maintaining access to ER/LA pain medications

Core competency training made available to
prescribers
Food and Drug Administration, 2012

2012: FDA issued Risk Evaluation
and Mitigation Strategy (REMS)
blueprint for extended release
(ER) and long acting (LA) opioid
medications

Collaborative on REMS Education
(CO*RE) designed core
curriculum based to meet FDA
educational requirements

Other comparable training
resources available (see
appendix)
CO*RE Nursing Partners
• American Association of Nurse
Practitioners
• Nurse Practitioner Healthcare
Foundation
• Medscape for Nurses
What is your current level of knowledge and to what
extent would this limit your opioid prescribing in the
following areas:
1. Federal and state regulatory guidelines
2. Opioid classes and the proper doses
3. Risk assessment (skills to detect abuse, misuse or
diversion of opioids)
4. Monitoring: (treatment goals, contracts, and patient
response)
5. Ability to deal confidently with challenges of opioid
prescribing
• December 2014-February 2015: Online survey sent
to licensed ARNPs in Florida database
• Respondents asked whether current level of
knowledge would limit prescribing
• Addressed all 5 knowledge domains.
• 1511 surveys completed/returned (16.8% response
rate)
• Neither Level of NP experience nor Level of NP education had
a significant (positive) effect on confidence in prescribing
opioids in all knowledge domains (p= < .005)
• When compared with all other work settings, more respondents
who work in Pain Management indicated no limitations with
prescribing
• Those with current or prior DEA licensure had a significant
(positive) effect on confidence(fewer limitations) in prescribing
opioids in all knowledge domains (p= < .005)
• Those with prior opioid training had a significant (positive)
effect on confidence (fewer limitations) in prescribing opioids
in all knowledge domains (p= < .005)
"Florida is on the verge of recovering from a
massive statewide pill-mill crisis. Yet now, the
Florida House is considering a bill that would
unleash thousands of new practitioners into our
communities with prescription pads poised to
prescribe narcotics."
- Alan Harmon, FMA President (2014)
We have a professional responsibility to:
1.
2.
3.
Prepare APNs for a new scope of practice before, not
after legislation passes
Socialize APNs and APN students to value full
autonomy
Educate policymakers about the benefits of fully
autonomous APN practice
Kaplan, L. & Brown, M.A. (2007). The transition of nurse practitioners to changes in prescriptive authority.
Journal of Nursing Scholarship, 39(2), 184-190.
Klein, T., & Kaplan, L. (2010). Prescribing competencies for advanced practice registered nurses. The Journal
for Nurse Practitioners, 6(2), 115-122.
Although the FDA Risk Evaluation and Mitigation Strategy
has been implemented, there is no mandatory
requirement to participate in any training program
Recent studies estimate that ~50% of physicians are
seeking training in FDA-compliant opioid prescribing
Imagine the impact if 100% of Florida’s ARNPs proactively
completed FDA-compliant Opioid Training prior to the 2016
legislative session?
Slevin, K. A., & Ashburn, M. A. (2010)








Pain Inventory Tools
Risk Assessment Tools
Treatment Guidelines
Sample Agreements and
Consents for Chronic Opioid
Therapy
Urine Drug Screening and
Testing
Tools for Monitoring
State guidelines
Patient Counseling
Document
AANP CO*RE Training online curriculum meets FDA Blueprint Guidelines
REMS for ER/LA Opioid Analgesics: The
Keys to Safe Use CME/CE
Katherine E. Galluzzi, DO; Barbara St.
Marie, PhD, ANP, GNP, ACHPN
CME/CE Released: 03/26/2015 ; Valid for
credit through 03/26/2016
CE: 2 hours
Cost: Free
This 3-part, online curriculum series meets FDA Blueprint Guidelines
ER/LA OPIOID REMS Achieving Safe Use While
Improving Patient Care
Presented by: CO*RE Collaboration Partners
https://www.nphf-core.com/
CE: 3 Pharmacology hours
Cost: Free
NPHF is accredited as a provider of continuing
nursing education by the American Nurses
Credentialing Center’s Commission on
Accreditation
Online curriculum for nurse practitioners consisting of six modules presented through
high definition, streaming video with interactive, embedded questions
Opioid Training Fishman (2014)
3 Training Modules:
1.
Risk Assessment, patient
selection and treatment
planning
2. Initiating, documenting
monitoring and discontinuing
therapy
3. Managing special risks
populations/situations
• CE included with book
Opioid Training: Webster and Dove (2007)
Resource Manual Only (No CE)
•
•
•
•
•
•
•
•
Epidemiology
Neurobiology of Addiction
Risk Factors
Assessing for Abuse
Documentation Tools
Monitoring Patients
Legal Issues
Abuse Deterrent Opioids
Alicia (Ali) Craig-Rodriguez, DNP-c, MBA, BSN, RN
Florida State University
FSU Email: aac13c@my.fsu.edu
Craig-Rodriguez, A. (2014). Educational interventions to improve opioid prescribing in primary care: A synthesis of the literature. Unpublished
manuscript, Department of Nursing, Florida State University, Tallahassee, Florida.
Fishman, S.M. (2012). Responsible opioid prescribing. A clinician’s guide. Washington, DC: Waterford Life Sciences.
Food and Drug Administration. Press Release: FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse. April 3, 2014.
Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm
Florida Office of the Attorney General (2012). Florida’s Prescription Drug Diversion and Abuse Roadmap 2012-2015. Retrieved from
http://myfloridalegal.com/webfiles.nsf/WF/KGRG-8T8L5K/$file/PrescriptionDrugDiversionAndAbuseRoadmap.pdf
Institute of Medicine. Relieving Pain in America: A blueprint for transforming care, education and research. The National Academies Press: 2011.
Laxmaiah Manchikanti, M. D., Standiford Helm, I. I., MA, J. W. J., PhD, V. P., MSc, J. S. G., & DO, P. (2012). Opioid epidemic in the United States.
Pain physician, 15, 2150-1149.
Lehne, R. A., & Rosenthal, L. (2014). Pharmacology for nursing care. Elsevier Health Sciences.
Kaplan, L. & Brown, M.A. (2007). The transition of nurse practitioners to changes in prescriptive authority. Journal of Nursing Scholarship, 39(2),
184-190.
Klein, T., & Kaplan, L. (2010). Prescribing competencies for advanced practice registered nurses. The journal for nurse practitioners, 6(2), 115-122.
Slevin, K. A., & Ashburn, M. A. (2010). Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies. Journal of
opioid management, 7(2), 109-115.
Webster, L. R., & Dove, B. (2007). Avoiding opioid abuse while managing pain. Sunrise River Press.