Florida holds the distinction as the last state to grant advanced registered nurse practitioners (ARNPs), which is the title used for advanced practice registered nurses (APRNs), prescriptive authority for controlled substances. This occurred in 2016 at a time when chronic pain was considered a national public health problem, affecting 116 million adults with an economic cost of $635 billion annually.1
These annual costs exceed those for heart disease ($309 billion), cancer ($243 billion), and diabetes mellitus ($118 billion).2 In 2012, healthcare prescribers, excluding Florida NPs, wrote 259 million prescriptions for opioids.3
A 2012 report from the Florida Office of the Attorney General listed Florida as the “epicenter of prescription drug diversion” in the United States, citing a sobering 2010 statistic from the Drug Enforcement Administration (DEA) that revealed Florida's physicians were dispensing five times more oxycodone than the national average.4 Weak regulatory oversight of pain management prescribing practices, coupled with a lack of practice standards and prescriber education, translated to more than seven deaths per day from accidental overdose in Florida during this 2010 period.4
In response to this epidemic, Florida implemented a Prescription Drug Monitoring Program in 2010, which resulted in a 23% decrease in prescription drug overdose deaths between 2010 and 2012.5 By 2014, Florida prescribers were writing 73 opioid prescriptions per 100 persons, ranking 37th in the United States.5
In 1994, the Florida Nurses Association made the state's first of several attempts to obtain ARNP prescriptive privileges for controlled substances.6 At that time, physicians and dentists were the sole prescribers of opioids in Florida. A law passed in 2016 authorized Florida ARNPs and physician assistants (PAs) to prescribe Schedule II–V controlled substances if they completed 3 hours of continuing education (CE) biennially for licensure and met the same standards of practice as physicians in prescribing opioids.7
The state's challenges surrounding the overprescribing of opioids, coupled with the fact that Florida ARNPs were prohibited from prescribing Schedule II–V controlled substances, suggest the importance of education to effectively prepare ARNPs for this important change in scope of practice. This article describes a study conducted prior to passage of controlled substance prescribing legislation in Florida that assessed whether a knowledge gap existed for Florida's ARNPs in the assessment, treatment, and monitoring of patients receiving opioids for chronic pain.
Prescriber knowledge, attitudes, and beliefs
There is widespread concern among providers about the risks of opioid prescribing, particularly the development of dependence, abuse, misuse, addiction, and diversion of opioids.8-10 This has influenced the attitudes and beliefs of prescribers, leading to a dilemma where prescribers are caught between their professional obligation to relieve a patient's suffering and concern about the risks associated with opioid treatment.8-16
Treatment of pain is a fundamental component of clinical practice; both undertreatment and overtreatment could be avoided by including comprehensive education to increase prescriber knowledge and competency.1 In addition, although chronic noncancer pain (CNCP) is one of the most common reasons a patient seeks healthcare, primary care providers feel ill-equipped and unprepared to adequately assess patients with CNCP and safely prescribe an opioid to relieve their pain.10,11,14,15,17-22 The First National Pain Medicine Summit of the American Medical Association highlighted these deficiencies and led to a unanimous agreement that the lack of evidence-based skills and knowledge precludes the delivery of adequate patient care.20
Prior to the 2011 adoption of a Washington state legislative initiative regulating pain management and opioid prescribing practices, Howell and Kaplan conducted a statewide survey to examine providers' opioid prescribing patterns focusing on CE preparation, use of best practices, and self-reported satisfaction and competence.18 Providers surveyed included medical and osteopathic physicians, ARNPs, PAs, and dentists—all of whom are authorized to prescribe opioids.
An important finding revealed that nearly 60% of the respondents rated themselves as being not at all, somewhat, or moderately competent to prescribe opioids. This may be explained by the fact that only 37.1% of study respondents reported completing CE on long-acting opioids, a training that would have allowed prescribers' patients to be exempted from the mandatory pain specialist consultation requirements when certain criteria are met.
Barriers to prescribing
While there is an abundance of literature addressing the barriers to opioid prescribing among physicians and medical residents, little evidence can be found addressing these same barriers among NPs. Washington state researchers described the transition to controlled substance prescribing among the state's ARNPs (NPs, nurse midwives, and nurse anesthetists) with a longitudinal study spanning 5 years.
Phase I, conducted just prior to the implementation of Schedule II–IV prescriptive authority, documented internal and external barriers to prescribing and served as a baseline for future comparison. The long-awaited legislative victory to Schedule II–IV prescriptive authority did not lead to its robust adoption because 50% of the state's ARNPs did not possess Schedule II–IV DEA registration 2 years after the legislation's passage.23
In Phases II and III of the study, research indicated statutory changes allowing Schedule II–IV prescribing eliminated one or more external practice barriers; however, new barriers developed and individual prescribing practices varied.19,23,24 In Phase IV, 22% of study participants reported that being poorly prepared by their initial educational preparation to prescribe controlled substances was an internal barrier to prescribing controlled substances.19
Florida ARNP prescribing
Until April 2016, Florida's ARNPs were the only APRNs in the country prohibited from prescribing controlled substances. With the elimination of this restriction, Florida ARNPs have the ability to prescribe Schedule II–V controlled substances on a limited basis if they have completed the requisite CE requirements (regarding the safe and effective prescribing of controlled substances).7
As a result of Florida's history of problems with opioid misuse, abuse, and diversion, ARNPs will face close scrutiny when prescribing opioids and other controlled substances. ARNPs, like physicians, will be expected to competently balance the clinical need of prescribing opioids for legitimate pain control while simultaneously managing the risks of opioid misuse, abuse, and diversion by their patients.11,16
This transition will require ARNPs to obtain updated information and prescribing strategies after decades of being restricted from using knowledge, skills, and attitudes acquired in advanced practice education programs. The transition to ARNP controlled substance prescribing is also an opportunity to assure the problems and pitfalls of physician opioid overprescribing in Florida are not replicated by ARNPs.
This study was conducted to determine whether Florida ARNPs perceive knowledge gaps and future practice barriers with regard to the safe management and prescribing of opioids and whether Florida ARNPs would benefit from an evidence-based educational intervention to improve clinical knowledge and overall confidence in prescribing opioids.
This descriptive study employed a cross-sectional design with a self-selected, nonprobability sample of licensed Florida ARNPs who responded to a request to participate in an online opioid knowledge assessment questionnaire.
The data collection instrument was a 17-item questionnaire developed from studies identified in a literature review and consistent with five key knowledge domains highlighted in a risk evaluation and mitigation strategy for the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.25 This blueprint, published in 2011 to address the opioid epidemic, requires accrediting bodies and CE providers to include content that prepares the prescriber to assess patients with chronic pain, initiate treatment, modify or discontinue doses of opioid analgesics, and manage and counsel patients on proper storage and disposal.
Three nursing scholars reviewed the questionnaire for content validity related to its aims and objectives; survey items were close-ended. Demographic data collected included age, gender, ethnicity, educational entry level to nursing and ARNP practice, years of practice, area of current practice, and current employment status. The remaining questions assessed the respondents' level of knowledge in five domains and whether this level of knowledge would limit their opioid prescribing. The questions focused on:
- Federal and state regulatory guidelines
- Opioid classes and the proper doses
- Risk assessment (skills to detect abuse, misuse, or diversion of opioids)
- Monitoring (treatment goals, contracts, and patient response)
- The ability to deal confidently with challenges of opioid prescribing.
Data were captured on a 5-point Likert scale and evaluated the extent to which respondents felt confident to prescribe opioids, providing insight into advanced practice nurses' readiness to prescribe and their interest to participate in future educational interventions.
Setting and subjects
The population for the study was the 13,956 NPs in the Florida licensing database with an unrestricted, active license, employed in Florida with a verifiable public e-mail address. The inclusion criterion was the willingness to participate in a web-based needs assessment survey.
The Florida Board of Nursing provided the list of licensed ARNPs in Florida. The list was filtered to include ARNPs with an active license, a public e-mail address, and who were employed in Florida. Following institutional review board approval, the questionnaire was made available through Qualtrics, an online survey tool.
Each licensee in the database received an introductory e-mail invitation with a link to the survey followed by two reminders 4 and 8 weeks following the initial e-mail. Participation in the study was voluntary, and consent was implied by the individual's participation. Data were collected from December 2014 to February 2015, and a total of 1,511 responses were received, yielding a 10.8% response rate.
Descriptive statistics were utilized to describe demographic characteristics of Florida's ARNPs and the extent of clinical and regulatory knowledge regarding the use of opioids in CNCP. Demographic characteristics included age, ethnicity, entry level into practice, educational achievements, prior DEA registration, and prior opioid training. Chi-square tests of association were performed to determine if there were associations between the demographic characteristics and each of the five knowledge domains.
A power analysis was conducted in GPower 3.1 using a moderate effect size, 80% power, and alpha = 0.05. Six degrees of freedom were chosen, as this was the largest possible number of degrees of freedom for any of the chi-square tests performed. The power analysis determined that, in order to detect significant effects, a sample size of at least 152 was required, which was exceeded.
Of the 1,511 respondents, over half were female (85.1%), White American (77.4%), and over age 50 (52.6%). The most frequently reported practice setting was primary care (38.0%) followed by hospital-based care (21.0%). More than half (52.4%) of respondents had over 10 years of advanced practice experience. In terms of education, training, and licensure, most (78.4%) respondents were master's-educated NPs. Sixty-nine percent reported previous opioid training, and 21% had previously or currently held DEA registration in another state (see Summary of participant demographics).
For each of the five knowledge domains, respondents were asked: “If the controlled substance legislation were to change to allow autonomous prescribing of controlled substances, indicate the degree to which the following concerns/feelings/factors would limit you from confidently prescribing opioids for chronic, non-cancer pain.” (See Summary statistics for each knowledge domain.)
Using chi-square tests of association, each of the five knowledge domains were analyzed by the demographic variables of entry level to nursing, highest level of education, years of advanced practice nursing (APN) experience, practice setting, prior opioid training, and current or prior DEA registration (see ARNP characteristics and opioid knowledge).
Prior DEA registration and prior opioid training both have statistically significant relationships with each of the five knowledge domains; years of APN experience, however, has no statistically significant relationship with any of the five knowledge domains (see ARNP characteristics and opioid knowledge domain associations).
The results of this study suggest that there is a statistically significant gap in knowledge and confidence among Florida NPs who have not had previous training in opioid prescribing or DEA registration. Those who did have prior opioid training and DEA registration reported more confidence in their knowledge of federal and state regulatory guidelines, opioid dosing regimens, risk assessment, and long-term patient monitoring.
Respondents with prior opioid training and those who worked in the pain management setting also reported fewer prescribing limitations in all five knowledge domains. A finding of particular interest is that the reported level of prescribing limitations increased as the level of entry to nursing also increased in all knowledge domains. The differences in ARNP prescriber limitation for early versus later entry into nursing could be explained by the fact that early entry nurses acquire nursing knowledge and confidence in an incremental manner as they matriculate to the APN level, whereas nurses who enter at a higher level of education acquire this same knowledge with a much shorter matriculation time.
Deficiencies in prescribing knowledge and preparation in the treatment of pain are not solely experienced by ARNPs; these same knowledge deficits are a well-documented problem in medical education.10,11,14,15,17,20-22,26 Understandably, this study revealed similar knowledge deficits for ARNPs who have yet to transition to controlled substance prescribing. Opportunities for educational preparation have been acknowledged and strongly encouraged for all prescribers as evidenced by the 2016 U.S. Department of Health and Human Services guidelines on opioid prescriber education and the commitment of more than 60 medical schools and 191 nursing schools to provide students with preparation that is in line with the CDC guidelines on opioid prescribing.27
Study findings are also consistent with previous research by Kaplan and colleagues, which revealed that educational preparation was an internal barrier that adversely affected an NP's prescribing of controlled substances.19 In a statewide survey of 1,488 Washington state NPs, the authors revealed that 22% of study respondents reported that their NP education “poorly prepared them to prescribe Schedule II–IV medications.”
Kaplan and colleagues also emphasized that both internal barriers (lack of educational preparation, preconceived attitudes and beliefs) and external barriers (laws prohibiting full scope of practice) must be removed. Florida ARNPs are required to practice in a supervisory relationship with a physician who must approve and sign an established protocol, which may present a barrier to controlled substance prescribing.
When considering educational approaches to prepare Florida ARNPs for this change in practice, it is helpful to examine the efforts of Washington state, considered by Kaplan and colleagues as an exemplar having achieved the educational, legal, and regulatory infrastructure for full-practice authority.19 Findings of a longitudinal study that began in 2001 and spanned 5 years provided valuable lessons and best practices—most notably the importance of educating and socializing ARNPs throughout the transition to controlled substance prescribing—with continued support in the months and years following the statutory change.19,23 Data from Kaplan and colleagues also revealed that when ARNPs and ARNP students were not adequately socialized to the value of fully autonomous prescribing, internal barriers to prescribing lingered long after the law changed.28
There are several study limitations to be considered. The survey questionnaire was created by the investigator, who designed the questions based on a review of the literature and other questionnaires. Although three nursing scholars reviewed the questionnaire, a pilot test was not conducted. In addition, online surveys are prone to self-selection bias and, as a result, it is difficult to know how nonresponders compare with responders, which limits generalization of the results.
Although the investigator adapted the questions to be applicable to the “future prescribing” practice for Florida's NPs, respondents may have difficulty responding to opioid-related questions prior to being granted authority to prescribe controlled substances.
Finally, survey nonresponses may have resulted from invalid or outdated e-mail addresses, employer spam-blocking tools, lack of Internet literacy in respondents over age 50, and Internet survey fatigue in the state. Offering multimode surveys, with a mail response to follow the initial web response, may not only increase response rates, but could also lend further credibility and legitimacy to the web survey.29,30
Education. State nursing leaders and educators are urged to address the educational needs of current ARNPs throughout the transition to support them in the safe and effective prescribing of opioids for treating CNCP. Preparation should include evidence-based education for prescribing opioids, including federal and state regulatory guidelines, opioid dosing regimens, risk assessment, and long-term patient monitoring.
Rational prescribing. There is an urgent need for Florida's ARNPs to assume the ethical responsibilities associated with the transition to full controlled substance prescribing authority. With the removal of statutory restrictions, ARNPs, like physicians, will be expected to competently and safely prescribe opioids for their patients while concurrently managing the risks of opioid misuse, abuse, and diversion. Section V of the DEA's Practitioner's Manual details the requirement for a valid prescription for a controlled substance with which all prescribers should be familiar.31
ARNPs are also urged to use evidence-based guidelines for prescribing opioids, such as the Washington State InteragencyGuidelineonPrescribingOpioidsforPain.32 CE conferences or online offerings also serve to enhance knowledge, skills, and attitudes for the rational prescribing of controlled substances.
Research. Although recent changes in legislation have removed an external barrier to controlled substance prescribing, other external barriers, primarily the requirement for physician supervision rather than full-practice authority, remain. In addition, internal barriers may take a period of time to be eliminated. For this reason, future studies are recommended to examine the impact of this transition as it relates to the future prescribing patterns of Florida's ARNPs.
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