Food and Drug Administration upscheduling of hydrocodone and the effects on nurse practitioner pain management practices

Rachel Mack, PhD, DNP, APRN, C-FNP, CNE

Journal of the American Association of Nurse Practitioners


Abstract

Background and purpose: In 2013, the Advisory Committee of the Food and Drug Administration determined hydrocodone combination medications (HCMs) needed tighter regulation due to high abuse potential; they recommended upscheduling HCMs from Schedule III to II. The purpose of this study was to examine the effect of upscheduling of HCMs on pain management practices of advanced practiced registered nurses (APRNs) in Oklahoma. 

Methods: In this qualitative study, 25 participants described their primary care experiences after the upscheduling. A thematic analysis was used to understand the effects on APRN pain management practices.

Conclusions: The upscheduling of HCMs has greatly affected the pain management practices of APRNs in a state where Schedule II narcotic prescribing is forbidden. Findings will assist APRNs with improving patient access to care, implementing practice regulations, and exploring options for alternative pain therapies in primary care.

Implications for practice: Upscheduling of HCMs has had a severe impact on APRNs, affecting their prescribing practices and leading to increased referrals. They noted limited treatment options, increased health care costs, and decreased access to care. The APRNs understand the problem of prescription opioid abuse, diversion, and misuse. A consensus model could standardize the regulatory process for APRNs, increase interstate mobility for practice, and increase access to APRN care nationwide.


Introduction

The upscheduling of hydrocodone combination medications (HCMs) occurred as a direct result of their high abuse and misuse potential. These medications are most widely prescribed by health care providers in the United States and have been associated with increased drug abuse, diversion, and misuse (United States Department of Health and Human Services Food and Drug Administration [USDHHS, FDA], 2014). Prescription drug abuse continues to escalate in the United States and contributes to increased emergency department visits, overdoses, and unintentional deaths. The Centers for Disease Control and Prevention (CDC) has classified prescription drug abuse as an epidemic and the fastest growing drug problem in the nation (Centers for Disease Control and Prevention [CDC], 2012). Drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules. The abuse rate is a determinate factor in the scheduling of the drug.

The Advisory Committee of the FDA convened at the beginning of 2013 determined that HCMs required more stringent regulation due to high potential for abuse and misuse (USDHHS, FDA, 2014). The advisory committee recommended an upschedule for HCMs, currently listed as Schedule III, to Schedule II (USDHHS, FDA, 2014). Schedule II medications are more difficult for patients to access, as they require an office visit and a written or electronic prescription with a maximum 30-day supply. The upscheduling of these medications took effect in November, 2013 (USDHHS, FDA, 2014). Not all advanced practiced registered nurses (APRNs) have been affected by this upscheduling because many states allow APRNs to prescribe Schedule II–V medications. Unfortunately, more than half the states in the United States do not allow APRNs to function at their peak capabilities and limit their narcotic prescribing to Schedule III–V. In some states, APRNs are not allowed to prescribe any narcotic medications (American Association of Nurse Practitioners, 2013). Because of this change, Oklahoma APRNs are no longer able to prescribe HCMs, creating another barrier for Oklahoma patients accessing primary care from an APRN (Oklahoma Board of Nursing Rules, 2015).

Oklahoma, like all states across the United States, is still in the midst of a prescription drug abuse epidemic (Center for Behavioral Health Statistics and Quality [CBHSQ], 2016). Approximately 5% of Oklahoma residents reported using prescription medications for nonmedical purposes compared with 1.4% nationally (CBHSQ, 2016; Oklahoma Prevention Leadership Collaborative, Prescription Drug Planning Workgroup [PDPW], 2016). Approximately 102,000 Oklahomans are addicted to prescription medications, and the number increases each year. Oklahoma has the 10th highest drug overdose death rate in the United States. Between 2010 and 2014, there were 3,500 unintentional poisoning deaths in Oklahoma, and 74% involved at least one prescription drug. Oklahoma’s opioid overdose rate in 2014 was 20.4 deaths per 100,000 people, which was higher than the national average of 12.8 per 100,000. Approximately 85% of these deaths were directly related to prescription narcotics, whereas only 15% were related to street drugs (PDPW, 2016). This epidemic causes increased health care costs each year. Daily across the United States, more than 1,000 people are treated in emergency departments for misusing prescription opioids. Around $78 billion is spent annually on health care costs associated with prescription drug abuse. Health care providers are prescribing more narcotics than ever before, leading to an increased number of people abusing prescription narcotics in Oklahoma and the rest of the United States (PDPW, 2016).

 

Purpose

The purpose of this research study was to identify whether APRNs’ pain management practices have changed with the upscheduling of HCMs in the state of Oklahoma. The following research question was addressed: What clinical pain management practices do APRNs use since the upscheduling of HCMs, and what meaning do these changes in prescriptive authority have for APRN comprehensive practice? There are significant gaps in the literature exploring the FDA’s upscheduling of HCMs and the effects on APRN pain management practices.

 

Methods

A phenomenological approach was used to address the research question. The first step in the systematic investigation of a lived experience is to identify if the research problem is best examined using a phenomenological approach. Phenomenology is appropriate when it is important to understand several individuals’ common or shared experience of a specific phenomenon. It is important to understand these experiences to develop a deeper understanding of the phenomenon, as is manifests to different individuals (Giorgi, 1986).

The process of data analysis was guided by Giorgi’s phenomenological method. The process involves reading the entire description of one subject to obtain a sense of the whole, followed by a second reading to identify, by marking or highlighting, places where transitions in meaning occur from a psychological perspective. The meanings between these transitions are called meaning units (Giorgi, 1986). Next, the meaning units are probed for what they reveal about the phenomenon of interest. Once the relevance of the subject’s own words for the phenomenon are grasped, the relevance is expressed in as direct a manner as possible. This is called the transformation of the subject’s lived experience into direct expression. Usually, following this procedure, a situated or general structure of the experience is presented as the final step (Giorgi, 1986).

 

Sample and setting

One institutional review board approved this study, and all participants gave written informed consent. Purposeful sampling was used by selecting participants based on characteristics such as being good informants and participants, knowing the information required, being willing to reflect on the phenomena of interest, having time, and being willing to participate (Creswell, 2013). The target population of the study was APRNs practicing in health care clinics in Oklahoma. Twenty-five participants were selected, and information gathering began and continued until data saturation had been reached. Saturation provides certainty and confidence that the analysis is strong and that the conclusions will be correct. When the data offer no new questions and no new direction, there is no need to sample further (Creswell, 2013).

Eligibility criteria for the study included APRNs who held a minimum of a Master’s degree as an APRN and had authorization to practice and prescribe in Oklahoma. Each participant supported that she or he was independently able to conduct personal business and legal transactions. Participants were 21 years of age or older and able to communicate in English. The exclusion criteria included any APRN who did not hold a minimum of a Master’s degree or was not nationally certified (Mack, 2016).

The research interviews were conducted in a private office location at the APRN’s health care clinic or another participant-selected location. The setting was selected based on geographical location and convenience for the study participant. The research interview was conducted in a quiet environment (Mack, 2016).

 

Data Collection

An interview guide (Table 1) was developed by the researcher. Four open-ended questions were asked, and four demographic questions were included in the interview guide. The open-ended questions focused on the participants’ experience in the upscheduling of HCMs. They also focused on the contexts or situations that have typically influenced or affected the participants’ experiences of the upscheduling of HCMs and the changes to their pain management practices. The demographic questions included the types of patients seen in the practice, the setting of the practice, highest degree earned, and number of years practicing.

When 25 participants were recruited, information gathering began and continued until data saturation was reached. Each interview session lasted approximately 60 minutes and was audiotaped. Data collection occurred over a 30-day period at the convenience of the participants, at times and locations of their choosing (Mack, 2016).

Analysis

The qualitative analysis was completed using the steps outlined by Giorgi (1986). First, the researcher manually transcribed the recorded interviews. Next, the entire transcript of one subject was read to obtain a sense of the whole. The interview was then read again to identify themes, by marking or highlighting. All the themes were examined to identify the phenomenon of interest. Once the relevance of the subject’s own words for the phenomenon was grasped, the relevance was expressed in as direct a manner as possible, transforming the lived experience into direct expression. As a final step, a situated or general structure of the experience was presented (Giorgi, 1986). Rigor was assessed by using the mnemonic, FACTS, which stands for fittingness, auditability, credibility, trustworthiness, and saturation (Hussein, Jakubec, & Osuji, 2015). The primary investigator consulted with an expert qualitative researcher to conduct member checks, review and confirm identified themes, and to conduct an overall audit of the qualitative research study (Mack, 2016).

 

Results

Twenty-five qualified participants were recruited and interviewed. Each interview was scheduled over a 1-hour period, with a majority lasting 30–45 minutes. Data saturation was reached early in the research study. The primary investigator continued to conduct interviews with all 25 participants to confirm that saturation was reached after the sixth participant interview, as no new information or themes were identified (Mack, 2016). The demographic summary of the participants is shown in Table 2. Three major themes were identified in the participants’ narratives: (a) barriers to effective pain management, (b) nurse practitioner regulation, and (c) alternative therapies.

Barriers to effective pain management

A majority of the respondents discussed how the FDA’s upscheduling of HCMs created barriers to effective pain management in the primary care setting, limited options for the treatment of pain, increased referrals to pain management specialists, and increased health care costs associated with treating acute and chronic pain. Several of the respondents also commented that the upscheduling had limited a specific category of providers who provided a majority of the primary health care to Oklahoma patients.

One participant said, “The FDA attempted to do a stellar job with the upscheduling and helping prevent unnecessary deaths. I believe that was the intent… what they did, however,… is exclude nurse practitioners in a category of states...who lost their ability to care for their patients appropriately. More than anything, I personally think with good consulting… the limitation has adversely affected patients and providers… by limiting the availability of treatment options that I need to use for a patient on a short-term basis.”

 

Increased patient referrals. The thematic analysis demonstrated that a majority of the participants were referring acute and chronic pain patients to pain management specialists. Several reported long waiting periods for the referral process, the need to drive more than one hour to access specialty care, and bad experiences with pain management specialists.

One participant said, “I send more patients to pain management now for acute and chronic pain… it can take 3 to 6 months… sometimes there is a poor relationship between the patient and specialist. One of my patients had legitimate problems… chronic issues like stenosis… I felt that we were managing her pain better as opposed to the pain management specialist… but I didn’t have a choice. I could no longer prescribe her medications. So the specialist increased her pain medication, added Neurontin, and essentially got her addicted to pain medication. Last I heard they were considering adding Oxycodone for breakthrough pain. I was managing her pain on much less medication with much better outcomes. Now you send them [patients] to pain management… hope they get taken care of… hope they don’t end up addicted, but you know [it] doesn’t end well. So I just have to adjust my practice. I just have to refer these patients.”

Limitations in treatment options. After the upscheduling, APRNs in Oklahoma were not allowed to prescribe HCMs. All the participants discussed the problems and concerns the upscheduling presented when trying to adequately treat a patient’s pain. This limitation left the APRNs very few choices to treat acute and chronic pain.

One participant said, “The only option we have if we need a narcotic is Tylenol 3 (acetaminophen/codeine), and the gastric effects like nausea...are not optimal by any means. The patient suffers because of the pain, and we can’t use the medications we need to control the pain. There are not enough options, dosing options. When you had hydrocodone, you had a lot of dosing options, as far as the amount of Tylenol, or if you wanted ibuprofen, how much hydrocodone. That made a huge difference. These other medications, like Ultram (tramadol), have more dangerous profiles, they lower the seizure threshold. They are also addictive, and the data supports that… [they are] not effective for pain.”

Increased health care costs. According to the participants, the upscheduling of HCMs has led to increased health care costs. This increase is associated with treating pain outside the primary care setting. Upscheduling has also led to an increase in emergency department visits and specialty provider visits for patients to receive adequate pain treatment.

One participant stated, “The new guidelines from the CDC say I should treat acute injuries with a narcotic for three days. This is considered appropriate care that I am no longer able to perform… not even able to do that… not even able to offer my patients appropriate care. They have to go somewhere else, to another specialist.”

 

Nurse practitioner regulation

The participants discussed the scope of practice for APRNs and how it varies by state, including autonomous practice in almost half the states and collaborative practice in the remaining states. Several participants discussed the importance of APRN regulation, which would allow all APRNs to practice to the full level of their educational training. This regulation would increase patient access to care and decrease health care costs.

One participant said, “I am a prescriber. I have the knowledge, ability, and education to prescribe this medication…but I can’t deliver different quality care in other states based only on the appropriateness of state-tostate rules…a real shot to the personal and professional standards that you can’t do what you need to do because of the differing laws in each state for NP practice.”

Impact of on-site physician. Two participants discussed how the upscheduling of HCM’s impact was not as difficult in their practices due to having a physician on site. They noted how this increased the liability for the physician, who is ultimately not assessing the patient, but is only prescribing the controlled substances. The majority of participants discussed the impact of not having a physician on site and how this limited prescribing options.

One participant said, “She [physician] ends up writing a lot of prescriptions for patients I see… I don’t like that… don’t feel like she should be responsible for writing prescriptions for patients who, yes, are seen under her roof in her building, but I don’t feel like she should have to write prescriptions for patients I am seeing, whom she is not evaluating.”

One participant said, “It is important to have consistent regulations across the United States. Nurse practitioners should have the same practice guidelines in each state. We are nationally certified; this is not a statespecific exam that we pass to practice, but a national certification. Consistent practice regulations would improve so many aspects of our role as a primary care provider.”

 

Alternative therapies

Participants noted that alternative therapies are being used in primary care more often since the upscheduling of HCMs. The participants agreed that there are many safe alternative treatments available like physical therapy, massage, herbal remedies, and preventive approaches. They also discussed barriers to alternative treatments; for instance, referring a patient to physical therapy in Oklahoma requires a signature from the APRN’s collaborating physician. However, some patients require more help than Oklahoma APRNs can offer after the upscheduling of HCMs.

One participant stated, “Each patient is varied and unique; we need more treatment options, safer options like physical therapy, massage, natural approaches, preventive approaches.”

Complementary medicine. All the participants stated that complementary medicines were used more frequently in primary health care since the upscheduling of HCMs. Several reported recommending over-the-counter rubs, patches, and stimulating units to help patients who suffer with chronic pain. Other participants reported that they were forced to find and research new approaches to pain management after the upscheduling.

One participant said, “I use a lot of alternative treatments. Different over-the-counter rubs, patches, stimulating units. I have even researched and helped a patient use herbs for pain relief.”

Another participant continued by stating, “I’ve had to find new approaches. The old-fashioned rest, ice, compress, elevate… use that a lot. Wraps impregnated with copper, all kinds of different things.”

Interventional medicine. It was also identified that APRNs used interventional medicine more frequently since the upscheduling of HCMs. A majority of the participants referred patients to orthopedics for steroid injections, which helped some patients, but not all. A few participants used new interventional approaches to medicine that use the patient’s own growth factors to heal damaged joints. One participant said, “I have sent a lot of patients to orthopedics for steroid injection. This has helped some… not all… even sent a few out for joint injections… results seem to vary.”

 

Discussion

Phenomenological assumptions are focused on the fundamental qualities of the phenomenon being studied and how it relates to the environment in which it occurs, thus linking the smaller areas of study to the broader focus. Explaining the underlying assumptions can assist in making the new information more readily acceptable. Assumptions can create barriers that limit the integration of generated knowledge, hindering the integration of knowledge into a larger area of study (Bendersky & McGinn, 2009). Bendersky and McGinn suggest that phenomenological assumptions be linked to the microprocesses to highlight the relevance of the research findings. This will then generate broader questions, therefore increasing the likelihood that the findings will disseminate to a larger field of research (2009). The assumptions were as follows: (a) APRNs are using alternative methods to successfully treat pain, which will have a positive impact on the patient’s well-being and decrease prescription drug abuse; (b) geographic location and health care coverage affect a patient’s ability to access health care services, negatively affecting a patient’s overall health and wellbeing; and (c) comprehensive health care, including pain management, is a goal of APRN practice.

Key findings were determined from the narratives of the participants about how they, as APRNs, responded to the upscheduling of HCMs and adjusted their pain management practices to treat pain in the primary care setting. Many similarities in the interviews were identified during the thematic analysis. During the research analysis, it also became apparent that Oklahoma APRNs continue to face legislative challenges for full practice authority (Mack, 2016).

Advanced practice registered nurses need to be able to adequately treat acute and chronic pain in the primary care setting, and patients with complaints of acute or chronic pain should not face barriers to effective pain management when scheduled to see a family practice APRN as the primary care provider. APRNs have been educated to order, perform, and interpret diagnostic tests, diagnose and treat acute and chronic conditions, prescribe medications and treatments, manage patients’ overall care, and provide patient counseling and education. The Institute of Medicine (IOM) Report The Future of Nursing: Leading Change, Advancing Health discusses concerned about the shortage of primary care health professionals in the United States. The IOM suggests that APRNs, if permitted to practice to the full extent of their education and training, could help build the workforce necessary to meet the country’s primary health care needs and contribute to the delivery of patient-centered, community-based health care (Institute of Medicine, 2011).

Participants reported that barriers to effective pain management practices have led to increased patient referrals, limitations in pain treatment options, and increased health care costs. The upscheduling of HCMs has limited the options that APRNs are able to provide to patients in the family practice setting for the treatment of acute and chronic pain. The APRNs in other states with collaborative practice and restricted narcotic prescribing have been severely affected by this upscheduling, which has limited access to necessary medications for the treatment of acute and chronic pain and adversely affected patients and providers. The research supports that decreasing a patient’s access to health care for the treatment of pain can lead to an increase in referrals, an increase in health care costs, limitations for treatment options by APRNs (Mack, 2016).

In the course of data analysis, it became apparent that the research question pointed to a symptom rather than the actual problem facing Oklahoma APRNs, who have long struggled with legislative issues that have hampered their ability to practice to the full extent of their education and training. Each attempt to pass full practice authority in the state has led to challenges. Currently, APRNs in 23 states have full practice authority, whereas APRNs in 16 states, including Oklahoma, have reduced practice authority. In contrast, APRNs in 12 states have restricted practice authority (Table 3). This research has identified the many challenges APRNs face and the importance of being active in health care policy. It is important to advance APRN practice and to advocate for full practice authority and licensure regulation across the United States (Mack, 2016).

It is important for APRNs to be politically active and involved, as this can have a positive effect on increasing access to patient care, scope of practice, and reimbursement. Patients and families will suffer without this political involvement, as many physicians are still opposed to expanding the scope of practice for APRNs. Political activism is an important facet for APRNs to become involved. These active APRNs can initiate communications through presentations, face-to-face meetings, emails, and discussion groups. The APRNs should also develop professional work groups and alliances to assist in unifying and promoting communication and the call to political action (Mack, 2016).

The National Survey on Drug Use and Health is considered the primary source of information on the use of illicit drugs, alcohol, and tobacco in the United States (CBHSQ, 2016). In the 2015 survey (n = 68,073), it was estimated that 1.4% of the US population over the age of 12 years are current misusers of narcotic pain medication, and approximately three million people have misused narcotic pain relievers in the last 30 days. These drugs are obtained from friends or relatives, health care providers, drug dealers, or strangers, and some are purchased from the Internet (CBHSQ, 2016). The survey also identified that approximately five million people used prescription pain relievers, 1.9 million used prescription tranquilizers, 1.7 million used prescription stimulants, and 446,000 used prescription sedatives for nonmedical purposes. It further identified that just over 4% of youths aged 12–17 years used prescription medications for nonmedical purposes. Young adults aged 18–25 years were identified as using prescription medication for nonmedical purposes more than any other age group (CBHSQ, 2016). Males were identified as using these medications more than females, and American Indians, Alaska Natives, and African Americans were found to use them more than other ethnicities. The survey also identified that people with some college education used prescription medication for nonmedical purposes more than people who did not complete high school. Additionally, unemployed people were identified to use these medications more than people who were employed (CBHSQ, 2016).

The upscheduling of HCM products has resulted in a drastic reduction in the number of written prescriptions and the total quantity of narcotic pain medication that were dispensed across the United States (Coleman, 2015; Seago, Hayek, Pruszynski, & Newman, 2016). Unfortunately, this dramatic reduction was offset by an even more substantial increase in alternative narcotic analgesics such as tramadol (Ultram), codeine/ acetaminophen 30/300 (Tylenol #3), and codeine/ acetaminophen 60/300 (Tylenol #4), which do not have Schedule II requirements (Coleman, 2015; Seago, Hayek, Pruszynski, & Greene-Newman, 2016). Although Schedule III medications are considered to have a lower potential for abuse than Schedule II medications, many health care providers are less familiar with these medication and are less equipped to handle the potential side effects.

Prescription drug abuse is an undeniable epidemic that the United States is facing. Although the FDA regulations show promise, there is very little published data regarding the effectiveness of specific drug policies like the upscheduling of HCMs (Coleman, 2015; Seago et al., 2016).

How to safely prescribe opioids is a facet of APRN education, and APRNs fully understand the problem of prescription opioid abuse, diversion, and misuse (American Association of Nurse Practitioners, 2014). In practice, APRNs use guidelines to manage acute, chronic, and low-back pain and have many available resources to assist with decreasing opioid misuse and abuse. As well, federal and state authorities have significant tools in place to address the current epidemic of prescription drug abuse (Wolfgang, 2013). The evidence is insufficient to predict whether the upscheduling of HCMs will successfully address the abuse and misuse of HCMs.

 

 

 

Limitations

One limitation of this study involved the validity of the data analysis. The primary investigator consulted with an expert qualitative researcher to conduct member checks, review, and confirm identified themes, and to conduct an overall audit of the qualitative research study (Mack, 2016). However, a validation process could have occurred through an audit by an external reviewer after the principal investigator and expert qualitative researcher originally finished the analysis process. This would have improved the validity of the study.

 

Conclusions

Despite differences among the participants in education, number of pain management patients seen in practice, and experience, some distinct commonalities in their approach to pain management after the upscheduling of HCMs were identified. Based on these findings, it is recommended that future researchers conduct similar studies focusing on the pain management practices of APRNs after the upscheduling of HCMs. Future research could focus more on the alternative therapies that are available for the treatment of pain because there are very limited data to support the use of these treatments.

Hydrocodone combination medication is among the most widely used pain medications to treat pain. The upscheduling of this highly addictive medication has not demonstrated a reduction in abuse or misuse (Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality, 2017). Mandatory education of all health care providers regarding pain management guidelines and alternative treatment options could potentially decrease abuse in the United States. It is recommended that the regulating agencies work together in transforming the pain management practices in the health care setting.

Advanced practice registered nurses are nationally certified and licensed to diagnose, treat, and prescribe medications. It is recommended that all APRNs begin educating the public and other providers about the importance of consistent APRN regulations in each state. The APRN associations and leaders should develop a campaign focused on regulatory practice, APRN scope of practice, and on the impact of APRN regulations on patients accessing appropriate health care. The upscheduling of HCMs has severely affected APRN practice, leaving limited narcotic medication options for use by APRNs and increasing the number of referrals to pain management specialists and other interventional specialists (Duffy, 2016). Therefore, it is recommended that APRNs develop clinic-specific guidelines for the referral process, the treatment of pain, and other complementary and alternative treatments that may be available in their practice area. It is also important for APRNs to develop relationships with other providers in the local area who may be able to prescribe Schedule II narcotics until the referral to the specialist can be complete. The outcomes of this research will provide APRNs with essential research-based information needed to help improve patient access to care, implement practice regulations, and explore options for alternative therapies to treat pain in primary care.


References

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