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

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.

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population.

BACKGROUND: In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population. OBJECTIVES: To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change. METHODS: This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply). RESULTS: The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001). CONCLUSIONS: The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

Pharmacists' perceptions regarding the impact of hydrocodone rescheduling on prescription volume, workflow management, and patient outcomes.

OBJECTIVES: To determine (1) pharmacists' perceptions of how rescheduling of hydrocodone combination products (HCPs) from Drug Enforcement Agency (DEA) Schedule III to DEA Schedule II has influenced prescription volume and revenue, pharmacy workflow management, and patient outcomes; and (2) whether perceptions differed between pharmacists who support versus those who oppose HCP rescheduling. DESIGN: A cross-sectional mail survey. SETTING: Texas community pharmacies from October to December 2015. PARTICIPANTS: One thousand randomly selected, registered Texas community pharmacists drawn from the Texas State Board of Pharmacy registry. MAIN OUTCOME MEASURES: Pharmacists' perceptions, measured on a 5-point Likert scale of HCP rescheduling and its impact on prescription volume and revenue, workflow management, and patient outcomes. Measures were developed specifically for this study. RESULTS: The response rate was 17% (n = 164). The majority of pharmacists (70.4%) supported HCP rescheduling. More than 80% of respondents perceived that the volume of 2 alternative pain medications-tramadol (DEA Schedule IV) and acetaminophen with codeine (DEA Schedule III) prescriptions dispensed-either "increased" or "significantly increased" (82.0% and 85.8%, respectively) following rescheduling. Overall, pharmacists who opposed rescheduling were significantly more likely to report negative perceptions regarding revenue (P = 0.0142), inventory management (P = 0.0024), and drug shortages (P = 0.0005) than those who supported rescheduling. However, pharmacists who supported rescheduling had more positive perceptions about electronic prescribing (P <0.0115), patient safety (P <0.001), drug abuse (P <0.0001), and legitimate use (P <0.0001). CONCLUSION: Results showed that legislative efforts, such as rescheduling HCPs, influenced pharmacists' perceptions of practice and patient outcomes. Currently, little is known regarding the impact of HCP rescheduling on pharmacy practice. As new laws are passed to address the opioid epidemic in America, more research will be needed to determine whether legislation is an effective means for managing appropriate access to HCPs and other narcotic analgesics.

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

BACKGROUND: The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy community expressed concerns of unintended consequences as a result of rescheduling. OBJECTIVES: This study examined physicians' intentions to prescribe HCPs after rescheduling using the framework of the theory of reasoned action (TRA). METHODS: A cover letter containing a link to the online questionnaire was sent to physicians of the Texas Medical Association who were likely to prescribe opioids. The questionnaire assessed physicians' intentions to prescribe HCPs after rescheduling. Predictor variables included attitude toward rescheduling, subjective norm toward HCP prescribing, and past prescribing behavior of schedule II prescriptions. All variables were measured on a 7-point, Likert-type scale. Intention to prescribe as a dependent variable was regressed over TRA variables and respondent characteristics. RESULTS: A total of 1176 usable responses were obtained, yielding a response rate of 13.3%. Mean (M) age was 53.07 ± 11 and most respondents were male (70%) and Caucasian (75%). Physicians held a moderately positive intention to prescribe HCPs (M = 4.36 ± 2.08), held a moderately negative attitude towards rescheduling, M = 4.68 ± 1.51 (reverse coded). Subjective norm was moderately low, M = 3.06 ± 1.78, and past prescribing behavior M = 2.43 ± 1.21. The linear regression analysis indicated that attitude (ß = 0.10; P = 0.006), subjective norm (ß = 0.35; P < 0.0001) and past prescribing behavior (ß = 0.59; P < 0.0001) were significant predictors of intention to prescribe HCPs after rescheduling. CONCLUSIONS: TRA was shown to be a predictive model of physicians' intentions to prescribe HCPs after rescheduling. Overall, physicians held a moderately positive intention to prescribe HCPs. Past behavior concerning schedule II prescribing was found to be the most significant predictor of intention. Understanding the impact of federal rule changes on pain management care and patient satisfaction is necessary to determine whether this change has produced the intended consequences without harming patients in need of HCPs.

An Online Survey of Patients' Experiences Since the Rescheduling of Hydrocodone: The First 100 Days.

OBJECTIVE: To conduct an Internet patient survey through the National Fibromyalgia & Chronic Pain Association on reactions to the first 100 days following the rescheduling of hydrocodone. METHODS: Face-valid survey questions were created with expert consensus along with repurposed questions used on previous NFMCPA surveys covering domains such as demographics and symptoms. The questionnaire was designed to be administered over the Internet. RESULTS: 6,420 responders met screening criteria and completed the survey. Most (5,181, or 82.5%) had been prescribed hydrocodone for more than 1 year. 2,296, (39.0%) reported no changes in access to hydrocodone, while the majority experienced some barriers. Of those who could no longer get hydrocodone, 1,067 (18.1%) borrowed pain medications, 1,007 (17.1%) turned to marijuana, 773 (13.1%) used alcohol, and 135 (2.3%) used illicit drugs. Most respondents had to visit their healthcare providers more often (N = 3,699, 64.2%) and 1,735 (30.3%) reported some type of issue interacting with their pharmacy. Most felt that the rescheduling was neither a fair nor appropriate solution to the abuse of hydrocodone (N = 4,938, 88.3%). For those still working, 801 (46.2%) reported that they had missed work because of the stricter regulations. 1,462 (27.2%) reported having thoughts of suicide since the rescheduling. SIGNIFICANCE: The unintended consequences for people with chronic pain that have been caused by the rescheduling effort to impede hydrocodone abuse are negatively impacting thousands. These consequences include suffering from being placed on less effective drugs, increased cost, inconvenience, and negative influence on physician-patient and pharmacist-patient relationships.

Rescheduling of combination hydrocodone products: problems for long-term care practitioners.

The Drug Enforcement Administration recently announced the final rule to reschedule hydrocodone combinations from schedule III of the Controlled Substances Act to the more restrictive schedule II category. This regulatory change will have broad operational implications for practitioners serving the health care needs of long-term care residents. Stakeholders will need to work collectively to identify possible efficiencies to counter some of the anticipated costs as well as its effect on patient care.

Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II. Final rule.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.