Hydrocodone Combination Products Research Articles

The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures.

To evaluate the impact of rescheduling hydrocodone combination products (HCPs) from schedule III of the Controlled Substances Act to the more restrictive schedule II on unintentional pediatric exposures (≤5 years old). Using U.S. data on outpatient retail pharmacy dispensing, emergency department (ED) visits, and poison center (PC) exposure cases, we assessed trends in prescriptions dispensed and unintentional pediatric exposure cases involving hydrocodone (rescheduled from III to II) compared to oxycodone (schedule II) and codeine (schedule III for combination products) using descriptive and interrupted time-series (ITS) analyses during the 16 quarters before and after the October 2014 rescheduling of HCPs. Dispensing of hydrocodone products was declining before rescheduling but declined more steeply post-rescheduling. In ITS analyses, both hydrocodone and oxycodone had significant slope decreases in PC case rates in the post versus pre-period that was larger for hydrocodone, while codeine had a small but significant slope increase in PC case rates. An estimated 4202 ED visits for pediatric hydrocodone exposures occurred in the pre-period and 2090 visits occurred in the post-period, a significant decrease of 50.3%. Oxycodone exposures showed no significant decrease. Pediatric hydrocodone unintentional exposure ED visits and PC cases decreased after HCP rescheduling more than would be expected had the pre-rescheduling trend continued; the acceleration in the decrease in hydrocodone PC cases was partially offset by a slowing in the decrease in codeine-involved cases. The trend changes were likely due to multiple factors, including changes in dispensing that followed the rescheduling. Unintentional pediatric medication exposures and poisonings remain a public health concern requiring ongoing, multifaceted mitigation efforts.

Competitive effects of federal and state opioid restrictions: Evidence from the controlled substance laws

A significant concern in the policy landscape of the U.S. opioid crisis is whether supply-side controls can reduce opioid prescribing without harmful substitution. We consider an unstudied policy: the federal Controlled Substance Act (CSA) restrictions placed in August 2014 on tramadol, the second most popular opioid medication. This was followed seven weeks later by CSA restrictions for hydrocodone combination products, the leading opioids on the market. Using regression discontinuity design (RDD) models, based on the timing of the (up-)scheduling changes, to explore spillover effects, we find that tightening prescribing restrictions on one opioid reduces its use, but increases prescribing of close competitors, leading to no reduction in total opioid prescriptions.This suggests that supply restrictions are not effective in reducing opioid prescribing the presence of close substitutes that remain unrestricted.

The impact of hydrocodone rescheduling on utilization, abuse, misuse, and overdose deaths.

To evaluate the impact of increased federal restrictions on hydrocodone combination product (HCP) utilization, misuse, abuse, and overdose death. We assessed utilization, misuse, abuse, and overdose death trends involving hydrocodone versus select opioid analgesics (OAs) and heroin using descriptive and interrupted time-series (ITS) analyses during the nine quarters before and after the October 2014 rescheduling of HCPs from a less restrictive (CIII) to more restrictive (CII) category. Hydrocodone dispensing declined >30% over the study period, and declines accelerated after rescheduling. ITS analyses showed that immediately postrescheduling, quarterly hydrocodone dispensing decreased by 177M dosage units while codeine, oxycodone, and morphine dispensing increased by 49M, 62M, and 4M dosage units, respectively. Postrescheduling, hydrocodone-involved misuse/abuse poison center (PC) case rates had a statistically significant immediate drop but a deceleration of preperiod declines. There were small level increases in codeine-involved PC misuse/abuse and overdose death rates immediately after HCP's rescheduling, but these were smaller than level decreases in rates for hydrocodone. Heroin-involved PC case rates and overdose death rates increased across the study period, with exponential increases in PC case rates beginning 2015. HCP rescheduling was associated with accelerated declines in hydrocodone dispensing, only partially offset by smaller increases in codeine, oxycodone, and morphine dispensing. The net impact on hydrocodone and other OA-involved misuse/abuse and fatal overdose was unclear. We did not detect an immediate impact on heroin abuse or overdose death rates; however, the dynamic nature of the crisis and data limitations present challenges to causal inference.

How Reclassification of Hydrocodone Combination Products Affects Dispensing.

How Reclassification of Hydrocodone Combination Products Affects Dispensing.

Changes in Hydrocodone Misuse Exposures Reported to U.S. Poison Centers Following Rescheduling in 2014

Background In 2014, the Drug Enforcement Administration rescheduled hydrocodone combination products to Schedule II to reduce nonmedical use and diversion. Methods The impact of rescheduling was assessed using quarterly data from 2011 through 2019 from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System Poison Center Program and IQVIATM Longitudinal Prescription Data. Trends and immediate changes in prescriptions dispensed and misuse exposures before and after rescheduling involving hydrocodone, oxycodone, and other Schedule II opioid analgesics were calculated using segmented regression. Results Hydrocodone prescriptions were stable pre-rescheduling, decreased by 2.7% (95% CI: −3.6%, −1.8%, p < 0.0001) per quarter post-rescheduling. Misuse exposures involving hydrocodone were decreasing by 3.2% (95% CI: −3.9%, −2.4%, p < 0.0001) per quarter pre-rescheduling and decreased by 4.9% (95% CI: −5.5%, −4.2%, p < 0.0001) post-rescheduling. Immediate decreases in hydrocodone prescriptions and misuse exposure rates in 2014Q4 compared to 2014Q3 were significant and different from oxycodone or other Schedule II opioids. Schedule II opioid analgesics prescriptions in aggregate were stable prior to rescheduling, decreased by 10.8% (95%CI: −14.0%, −7.6%, p < 0.0001) immediately after the rescheduling, and decreased by 2.3% per quarter (95% CI: −3.1%, −1.5%, p < 0.0001) subsequently. Misuse exposures involving these opioids were decreasing by 3.3% (95% CI: −4.1%, −2.5%, p < 0.0001) prior to rescheduling then by 2.8%, (95% CI: −3.4%, −2.2%, p < 0.0001) after rescheduling. The immediate change in misuse was not significant. Conclusions Rescheduling corresponded with changes in hydrocodone prescribing and misuse not offset by increases in other Schedule II opioid analgesics. Misuse exposures for hydrocodone and comparators were decreasing prior to rescheduling with little change post-intervention.

Trends in hydrocodone combination product exposures reported to California Poison Control System (CPCS) following DEA rescheduling

Context On October 6, 2014, the United States Drug Enforcement Administration (DEA) implemented a regulatory change for hydrocodone combination products (HCPs), moving them from Schedule III to II, in an effort to decrease drug overdoses. Existing research suggests this regulatory action reduced HCP prescribing and dispensing; however, there is limited research assessing its possible effects on overdoses and accidental exposures. Objective To analyze the changes in opioid exposures reported to the California Poison Control System (CPCS) before and after DEA rescheduling of HCPs. Methods We collected monthly exposure data reported to CPCS from 2012 to 2019 and conducted interrupted time series analyses to assess changes in exposures after rescheduling for HCPs, tramadol, oxycodone, morphine, codeine, fentanyl, and heroin. Additional analyses were done to assess any changes in exposures resulting in severe outcomes (moderate or major health effects). For HCPs, we also conducted logistic regressions to identify characteristics of exposures resulting in severe outcomes before and after rescheduling. Results Overall monthly opioid exposures reported to CPCS decreased after DEA rescheduling of HCPs. These decreases were significant for HCP, tramadol, and morphine (p < 0.001). Exposures significantly increased for heroin and fentanyl (p < 0.001). There were no significant changes in the share of severe outcomes attributed to HCP exposures after rescheduling. Discussion The DEA rescheduling of HCPs was associated with a significant decrease in HCP exposures and prescription opioid exposures overall, but was associated with increased fentanyl and heroin exposures. While other initiatives may have contributed to this decrease, our findings suggest that rescheduling may be a useful regulatory strategy to reduce drug exposures. Conclusion DEA rescheduling of HCPs was associated with a significant reduction in prescription opioid exposures, suggesting that rescheduling high-risk drugs may be an effective strategy to improve public health.

Quantification of Opioid Prescription Practice Changes Due to Hydrocodone Combination Product Rescheduling in an Academic Pain Clinic.

PurposeTo determine the effect of rescheduling on prescription practices in a large academic hospital-based multidisciplinary practice comprising anesthesiologist-trained pain physicians.Patients and MethodsWe examined the number of HCP prescriptions written and quantity of tablets prescribed during a 6-month period prior to rescheduling and compared this with a 6-month period 1 year after rescheduling. We also examined the changes in prescription of tramadol and acetaminophen with codeine from one period to the next.ResultsOur pain clinic conducted 3,320 office visits during the 6-month period prior to HCP rescheduling and 6,003 office visits in the 6-month period 1 year after rescheduling. The charted data from each of these visits were used for our analysis. The mean number of tablets of HCPs prescribed per patient decreased from 318.48 in the pre-period to 242.27 tablets in the post-period, while the mean number of HCP prescriptions per patient decreased from 2.24 to 1.84. The mean number of acetaminophen with codeine tablets prescribed per patient increased from 3.46 to 15.27 in the pre- and post-period. Similarly, the mean number of tramadol tablets per patient increased from 47.33 to 61.97 in the pre- and post-period. The mean number of acetaminophen with codeine and tramadol prescriptions per patient increased from 0.02 to 0.15 and 0.38 to 0.51 in the pre- and post-period, respectively. In the 6-month post-period, fewer new patients were started on opioids compared to the 6-month pre-period, 16% and 27%, respectively.ConclusionOur study showed a significant decrease in the mean number of HCP prescriptions written per patient, as well as a decrease in the mean number of HCP tablets prescribed. Pain physicians in our clinic increased the number of prescriptions for the non-HCPs. The number of acetaminophen with codeine and tramadol tablets prescribed significantly increased. Therefore, the rescheduling of HCPs has profoundly impacted practices within this academic pain clinic.

Rescheduling hydrocodone combination products: Impact on patients receiving long-term HCP therapy in a large chain pharmacy—A statewide assessment

ObjectiveThis study aimed to evaluate the rescheduling of hydrocodone combination products (HCPs) from schedule III (CIII) to schedule II (CII) in patients receiving chronic HCP therapy. MethodsThis study was a retrospective cohort analysis of administrative pharmacy data from 118 statewide pharmacies from a retail chain in Tennessee. HCP filling histories were analyzed on patients meeting enrollment criteria from July 1, 2014, to October 1, 2015. The average number of tablets dispensed, daily average of the number of tablets dispensed, and monthly average of morphine milligram equivalents (MME) dispensed were compared for the periods of July 1, 2014, to October 5, 2014 (enrollment period before schedule change) and October 6, 2014, to October 1, 2015 (period following schedule change) using a pooled t test. ResultsA total of 4536 patients met the inclusion criteria. Of these 4536 patients, 60.6% were female, and 40.4% were male, with an average age of 58 years (patients included in this study were between the ages of 18 and 99 years). The total number of hydrocodone tablets dispensed in the 12 periods after the schedule change dropped from 467,217 to 259,327, a 45.5% reduction (P < 0.001). Total MME decreased from 4.11 to 2.29 million, a 45.3% reduction (P < 0.001). The number of study participants still receiving an HCP at the end of the study decreased to an average of 2736 across the 12 periods following the schedule change, a 40% reduction. ConclusionHCP dispensing and use decreased among patients receiving chronic opioid treatment from a large corporate statewide community pharmacy in Tennessee after a schedule change from CIII to CII. Monthly sums of total tablets dispensed, average daily tablets dispensed, MME, and average daily MME calculated from July 1, 2014, to October 1, 2015, all experienced statistically significant reductions.

Opioid-prescribing Practices in a Graduate Endodontic Clinic before and after Implementation of the Federal Schedule II Prescribing Mandate

IntroductionOpioid prescriptions have the potential for misuse. In October 2014, the federal schedule II prescribing mandate reclassified hydrocodone combination products from schedule III to schedule II drugs that required a written prescription. The aim of this study was to evaluate the opioid-prescribing practices in a graduate endodontic clinic (GEC) before and after the mandate. MethodsElectronic health records from all patients treated in the GEC from 2010 to 2018 were reviewed retrospectively for opioid prescribing, the date of prescription, and the Current Dental Terminology code. Where opioid prescribing was documented in the electronic health record, additional data were extracted about pulpal and periapical diagnosis, pain level, opioid type, and prescription details. Prescribing rates were calculated and analyzed by using chi-square, analysis of variance, logistic regression, and multivariable analysis. Significance was set at P < .05. ResultsOverall, 4851 patients underwent 7841 procedures; 92.2% of patients were never prescribed opioids. The remaining 380 patients underwent 420 procedures, and 509 prescriptions were provided. Prescribing rates were 7.5% (228/3021) before versus 4.0% (192/4820) after the mandate (P < .001). Hydrocodone combinations were the most prescribed opioid (77%, 392/509). Tramadol prescribing increased after the mandate (P = .023). Multivariable analysis showed significantly higher prescribing for apicoectomy procedures (P < .001). Preoperative pulpal and periapical diagnosis and pain level were not significantly associated with opioid prescribing. ConclusionsAn overall reduction in opioid-prescribing rates occurred coincidentally with the 2014 federal mandate. The lack of correlation between prescribing and pain level highlighted the need for evidence-based rather than habitual prescribing protocols in the GEC.

161. Effects of Drug Enforcement Agency (DEA) narcotic restrictions on a multidisciplinary spine practice: analysis of patient discharges from the practice during a 10-year period

BACKGROUND CONTEXT In the late 1990s to early 2000s, concern about pain under-treatment resulted in greater numbers of prescriptions for pain medications being written across the United States. After this, according to CDC data, from 1999 to 2017, more than 700,000 people died from a drug overdose with approximately 68% of the more than 70,200 opioid-related overdose deaths in 2017 alone. Government agencies across the country have taken measures to address this alarming trend. An instrumental change occurred on October 6, 2014 when the US Drug Enforcement Agency (DEA) rescheduled hydrocodone combination products from Schedule III to Schedule II to make obtaining narcotics more difficult. PURPOSE The purpose of this review was to investigate the effects of DEA policy changes on patient discharges in a multidisciplinary spine practice. STUDY DESIGN/SETTING This study involved a review of patient discharges from a spine specialty clinic due to violations of the medication contract between patients and the clinic. PATIENT SAMPLE The study was based on all patients who were seen at a multisite spine specialty clinic between 2008 and 2018, with no changes in discharge policy during this time. There were a total of 636 patients discharged from the practice during this time. OUTCOME MEASURES The primary outcome measure was the occurrence of patient discharge from the practice. The specific reason for each discharge related to violating the medication contract and/or for noncompliance was recorded. METHODS All patients were required to sign a medication contract noting that abuse of medication subscription policy would result in discharge of the patient from the practice. Patients also agreed to random drug screening to determine compliance with prescribed medication. All patient discharges are reviewed and recorded by the medical administrator of the practice. The number and reasons for discharges were compiled into a monthly summary. Reasons for discharges were recorded as obtaining medication from another provider, diversion, self-medicating/early refills/drug overdose, refusal or alteration of urinalysis sample, altering a prescription, rude/abusive behavior, and noncompliance/failed to show for appointments. The years 2008 through 2013 were combined as the experience prior to the DEA change and 2015 through 2018 were combined as the post-DEA change years. The year 2014 was not included since the change in DEA policy was implemented during that year. The number of discharges occurring during each of the two periods was divided by the number of individual patients seen (counted by individual patients, not patient visits) during the same periods to derive a discharge rate for each reason. RESULTS Before and after the DEA changes, the most frequent reason for medication violation discharge from the practice was obtaining medication from other practitioners. However, the discharge rate for this violation decreased significantly after the DEA change was implemented (0.29% vs 0.02%; p CONCLUSIONS This analysis found that rescheduling of Hydrocodone from Class III to Class II by the DEA was associated with reduced patient discharge rates from a spine specialty practice. Significant decreases in discharges were found for medication-related policy violations, especially obtaining medication from other providers. While these reductions are a positive impact of the DEA policy change, one item that could not be addressed in the current analysis was the potential for increased difficulty for patients legitimately trying to fill prescriptions, for example, postoperative pain management following complex reconstructive spine procedures. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

PMU49 CHANGES IN ANALGESIC PRESCRIBING AMONG TEXAS ADVANCED PRACTICE PROVIDERS AFTER RESCHEDULING OF HYDROCODONE COMBINATION PRODUCTS

In 2014, the Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) from schedule III to schedule II. The study objective was to determine if the rescheduling of HCPs influenced the analgesic prescribing choice that Texas Advanced Practice Providers (APPs) (i.e., nurse practitioners [NPs] and physician assistants [PAs]) provide to patients who are in need of pain management. A cross-sectional survey design was employed. The self-administered online questionnaire for the APPs was developed utilizing the Theory of Reasoned Action and included questions about pain management strategies. Data analyses involved measurement of descriptive statistics related to questions about planned treatment alternatives or substitutions for HCPs and, determination of inter-item reliability and correlations. An a priori significance level of P < 0.05 was used for all statistical tests. SAS® version 9.4 was used for statistical analyses. Responses from 1,059 APPs were collected with a 17.6% response rate. The mean age of respondents in this study was 47±12 years with 74% females. Most (71%) of APPs believed that rescheduling HCPs has altered their pain management care. With respect to non-cancer pain management (NCPM), (20.62%) of the APPs who reported using the PDMP reported prescribing schedule II opioids for less than 20% of their patients. Over half (54%) stated that they intended to prescribe acetaminophen with codeine after rescheduling of HCPs. Most (73%) of the prescribers reported that they were very likely/quite likely to prescribe tramadol or tramadol/acetaminophen combination products to treat acute non cancer pain. Advanced Practice Providers (APPs) are influenced by the change in policy in Texas due to lack of schedule II prescriptive authority and believe that the rescheduling has resulted in an alteration in the pain management care of patients. Further research is required to assess if rescheduling has contributed to reduction in drug misuse and diversion.

Drug Enforcement Administration Rescheduling of Hydrocodone Combination Products Is Associated With Changes in Physician Pain Management Prescribing Preferences

Due to rising misuse, the Drug Enforcement Administration (DEA) moved hydrocodone combination products (HCPs) from DEA Schedule III to DEA Schedule II in October 2014. Aside from increasing regulatory scrutiny, rescheduling may have increased the administrative burden surrounding HCP prescribing. This study explored how HCP rescheduling and associated administrative barriers may have affected physician treatment of acute (aNCP) and chronic (cNCP) noncancer pain. To this end, physician members of the Texas Medical Association completed a self-administered online questionnaire. Pharmacotherapy treatment plan was measured with two questions asking physicians whether they were more likely to recommend HCPs, acetaminophen/codeine (APAP/codeine), nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, or other agents for the treatment of aNCP and cNCP. Two Likert-scaled items were used to assess administrative burden. In total, 1365 physicians responded (response rate = 15.39%). Physicians more frequently selected APAP/codeine (37%) for aNCP and tramadol (44%) for cNCP. A majority (78.8%) of physicians agreed that rescheduling led to modified prescribing, and those in agreement were significantly less likely than those who disagreed to prescribe HCPs for aNCP (24.2% vs. 56.4%; χ2 = 68.6, P < .001) and cNCP (16.9% vs. 37%; χ2 = 36.1, P < .001). Rescheduling and associated administrative burden are both associated with modified physician HCP prescribing in both aNCP and cNCP.

Impact of hydrocodone reclassification on analgesic prescribing in the Veterans Health Administration.

The impact of hydrocodone reclassification on analgesic prescribing in the Veterans Health Administration (VHA) was quantified. In this retrospective observational study, the volume of opioid medication dispensed was calculated quarterly from October 2011 to September 2015 using national VHA administrative data. Four volume measures were examined (prescription count, tablets dispensed, days' supply dispensed, and unique patients) for 4 opioid groups: hydrocodone combination products (HCPs), other opioid combination products, tramadol, and single-agent Schedule II opioids. HCP prescription count was further tabulated within longitudinal course of receipt groups: short-term, intermediate-term, and long-term. The initiation frequency of alternative analgesic pharmacotherapy, including opioid and nonopioid medications, was assessed among patients who discontinued long-term HCP receipt at reclassification. HCP prescriptions declined by 172,535 (19.4%) in the quarter after reclassification, whereas other opioid categories remained unchanged. The number of HCP prescriptions decreased by 10.7% among patients with short-term opioid receipt, and by 23.3% and 19.4% for intermediate- and long-term receipt groups, respectively. Among 13,416 individuals who discontinued receipt of long-term HCPs, replacement analgesics were not identified in 8,055 (60.0%) patients, whereas prescriptions for alternative opioids were observed in 3,557 (26.5%) and nonopioids in 2,753 (20.5%). HCP dispensing in VHA declined by 19.4% in the quarter after reclassification, which was driven largely by patients receiving long-term therapy. More than 13,000 veterans discontinued receipt of long-term HCP therapy after reclassification and the majority did not receive a replacement analgesic through VHA.

The effect of a more strict 2014 DEA schedule designation for hydrocodone products on opioid prescription rates in the United States

Background: From 1999 to 2010, the annual number of US deaths due to opioid overdose increased about 400% as the number of opioids prescribed yearly also increased by approximately 400%. Over this period, hydrocodone combination products drove the opioid epidemic, as they became the most frequently prescribed medication in the United States. Our objective was to determine if the Drug Enforcement Administration’s (DEA) 2014 policy change – which made it more difficult to prescribe hydrocodone combination products by moving them from Schedule III to Schedule II – reduced the total amount of opioid prescriptions as intended.Methods: We conducted a longitudinal analysis of the 10 most populous US states, beginning at the time each state began collecting data on opioid prescribing, and concluding at the end of 2016. The exposure was the DEA-mandated October 6, 2014 hydrocodone combination product schedule change.Results: After the DEA’s schedule change for hydrocodone combination products, the total number of opioids prescribed each year per 100 people did not substantially change in California, Florida, Michigan, or New York. Although prescription rates dropped for hydrocodone combination products (CA: 43.2, 35.0; MI: 66.8, 55.6; NY: 20.8, 15.1), the reduction was commensurately counteracted by increased rates for tramadol (CA: 0.2, 9.9; MI: 0.1, 17.3; NY: 0.0, 7.6) and oxycodone (CA: 8.7, 9.7; MI: 10.3, 11.9; NY: 18.1, 18.8). Surprisingly, the other 6 states assessed had no viable mechanism in place for assessing state-wide opioid prescription totals, routinely expunged collected data, or only instituted a reporting mechanism toward the end of our study.Conclusion: Total opioid prescriptions were relatively unchanged following the 2014 DEA-mandated schedule change, however, physicians did change their prescribing habits by substituting tramadol for hydrocodone combination products. This substitution of similar medications for hydrocodone suggests alternative approaches are needed to reduce total US opioid prescription rates. Additionally, the current lack of standardized prescription reporting by states makes detailed opioid prescription analysis alarmingly difficult and insufficient to guide policy or monitor the impact of policy changes.

Using trajectory models to assess the effect of hydrocodone upscheduling among chronic hydrocodone users.

In October 2014, the US Drug Enforcement Agency moved hydrocodone combination products (HCPs) from schedule III to II of the Controlled Substances Act, further restricting their access. The aim of the study is to quantify the effect of hydrocodone's "upscheduling" on the use of opioid and nonopioid analgesics among chronic users. Using IQVIA LRx LifeLink anonymized pharmacy data 2013 to 2015, we performed interrupted time series analysis and group-based trajectory modeling to characterize the effect of rescheduling on 316731 long-term hydrocodone users. Main measures were the number of prescriptions, patients, tablets, and morphine milligram equivalents of opioids and nonopioid analgesics pre and post the policy change. We used logistic regression to assess the relationship between sociodemographic characteristics and these measures. The schedule change was associated with significant declines in opioid prescriptions (20.9%, from 421798 to 333627) and the number of patients using opioids (11.4%, from 307974 to 272804). Majority of hydrocodone users filled prescriptions for nonopioid analgesics with some declines in the number of users after the schedule change (5.2%, from 181085 to 171758). Based on group-based trajectory models, majority of patients continued to fill HCP prescriptions consistently after the policy change, while 15.4% showed large declines in HCP use, accounting for two-thirds of the decrease in opioid volume. There was no evidence that the policy change was associated with significant increases in the use of alternative analgesics. The upscheduling of hydrocodone led to reductions in opioid use, which were concentrated among a small subset of chronic hydrocodone users, without evidence of commensurate increases in the use of alternative pharmacologic pain treatments.

Impact of rescheduling hydrocodone-combination products in an urban Texas county healthcare system.

The objective of this study was to examine the rescheduling of hydrocodone-combination products (HCPs) and associated changes in prescriber patterns in an urban county healthcare system in Texas. Pharmacy data were obtained electronically for tramadol, hydrocodone-acetaminophen, and acetaminophen-codeine from 180 days before and after the schedule change on October 6, 2014. x2 and t tests were used to calculate the significance of changes between the medications over the studied time. Hydrocodone-acetaminophen saw a decline in dispense events and pills dispensed of 80.2 and 67.9 percent, respectively, in the immediate 30-day period following the scheduling change with a total decrease of 80.8 and 67.5 percent, respectively, in the 180-day period. Acetaminophen-codeine dispense events and total pills dispensed increased by 302.3 and 288.9 percent, respectively, in the immediate 30-day period while 180-day results experienced an increase of 215.1 and 209.8 percent, respectively. There were no major changes with tramadol. Additionally, an increase of 69.5 percent in pills per dispense event of hydroco-done-acetaminophen was noted in the 180-day period following the schedule change. The scheduling change of HCPs is associated with an immediate decrease in hydrocodone-acetaminophen use at our institution while a simultaneous rise in acetaminophen-codeine products was observed.

Effect of restricting the legal supply of prescription opioids on buying through online illicit marketplaces: interrupted time series analysis

ObjectiveTo examine the effect on the trade in opioids through online illicit markets (“cryptomarkets”) of the US Drug Enforcement Administration’s ruling in 2014 to reschedule hydrocodone combination products.DesignInterrupted time series...

Characterizing Abuse Progression of Immediate-Release Hydrocodone Combination Products

This study examined patterns of hydrocodone combination product (HCP) abuse and their potential role in abuse progression of prescription opioids and other drugs. An Internet survey was administered to 472 adult opioid users in the United States who used HCPs nonmedically. Alternate routes (33%) and concomitant drug use (45%) were indicated more frequently during respondent’s most recent HCP nonmedical use compared with their initial use (20% and 24%, respectively). Those initiating HCP nonmedical use during adolescence used alternate routes (e.g., chewing, snorting) throughout their lifetime more frequently (69.5%) compared with those older when initiating HCP nonmedical use (51.0%). A different abuse pattern was observed from first to most recent HCP use, starting with oral administration of intact tablets followed by use of alternate routes and concomitant use of illicit drugs, sometimes use of heroin. These data may inform future public health interventions, including the potential development of abuse-deterrent immediate-release opioids.

Decline in opioid prescribing after federal rescheduling of hydrocodone products.

To examine differences in opioid prescribing by patient characteristics and variation in hydrocodone combination product (HCP) prescribing attributed to states, before and after the 2014 Drug Enforcement Administration's reclassification of HCP from schedule III to the more restrictive schedule II. We used 2013 to 2015 data for 9202958 patients aged 18 to 64 from a large nationally representative commercial health insurance program to assess the temporal trends in the monthly rate of opioid prescribing. HCP prescribing decreased by 26% from June 2013 to June 2015; the rate of prescriptions for any opioid decreased by 11%. Prescribing of non-hydrocodone schedule III opioids increased slightly while prescribing of non-hydrocodone schedule II opioids and tramadol was stable. Absolute decreases in HCP prescribing rates were larger in patients being treated for cancer (-2.26% vs -0.7% for non-cancer patients, P<0.0001) and in those with high comorbidities (-2.13% vs -0.55% for those with no comorbidity, P<0.0001). Differences in the absolute and relative changes in HCP prescribing rates among states were large; for example, a relative decrease of 46.7% in Texas and a 12.7% increase in South Dakota. The variation in HCP prescribing attributable to the state of residence increased from 6.6% in 2013 to 8.7% in 2015. The 2014 federal policy was associated with a decrease in rates of HCP and total opioid prescribing. The large decrease in the rates of HCP prescribing for patients with actively treated cancer may represent an unintended consequence.

Impact of Rescheduling Hydrocodone Combination Products Among Cancer Patients

Many cancer patients experience significant pain requiring the use of an opioid pain medication such as hydrocodone. On October 6, 2014 the DEA rescheduled hydrocodone combination products from Schedule III to Schedule II of the Controlled Substances Act. Schedule II rules are closely enforced by the DEA and caregivers are fined for non-compliance. In addition, mid-level providers and residents are not able to write for schedule II drugs, so this limits the number of providers able to prescribe opioid pain medications. It has been hypothesized that such rescheduling will cause significant delays for patients who require such medications leading to uncontrolled pain, more emergency department visits and increased risk of readmission. The purpose of this study is to investigate what changes physicians and other healthcare providers have made to their prescribing practices as a result of this rescheduling. With IRB approval, prescription and pharmacy pick-up data for Tramadol, Hydrocodone-acetaminophen (Norco) and Tylenol 3 for all patients within a regional safety net health system were obtained. The time-frames in which data was collected were 6 months before the rescheduling date (April 5, 2014 – October 5, 2014) and 6 months after (October 6, 2014 – April 6, 2015). This dataset was then linked with the health system’s cancer database to identify all cancer patients receiving any one of these pain medications. P-values and confidence intervals were calculated using the N-1 chi square test. Total pills dispensed. Among all patients, considering these 3 pain medications, Norco dropped from 50% of the total pills dispensed before the rescheduling to 23.2% after while Tramadol saw a modest increase from 44.3% to 54.0% and Tylenol 3 saw a significant increase from 5.7% to 22.8%. Among cancer patients Norco dropped from 79.3% to 58.1% while Tramadol increased from 16.2% to 23.7% and Tylenol 3 increased from 4.5% to 18.2%. Total pills dispensed, overall saw a 28.5% decrease in all patients from before the rescheduling to after and in cancer patients there was a 24.5% decrease.Abstract 3252TramadolP-valueTylenol 3P-valueNorcoP-valueAll patientsApr 5 2014 – Oct 5 20141277116 (44.3%)163318 (5.7%)1443782 (50.0%)Oct 6 2014 – Apr 6 20141113033 (54.0%)470110 (22.8%)479003 (23.2%)Difference9.69% (CI: 9.61-9.79)<0.00117.13% (CI: 17.07-17.20)<0.00126.83% (CI: 26.75-26.91)<0.001Cancer patientsApr 5 2014 – Oct 5 201470301 (16.2%)19716 (4.5%)344290 (79.3%)Oct 6 2014 – Apr 6 201477859 (23.7%)59605 (18.2%)190570 (58.1%)Difference7.58% (CI: 7.37-7.73)<0.00113.63% (CI: 13.48-13.78)<0.00121.18% (CI: 20.97-21.39)<0.001 Open table in a new tab The rescheduling of hydrocodone products has dramatically changed prescriber patterns in our health system. Further research is warranted to understand the impact on pain scores.