SCIENCE AND PRACTICE Journal of the American Pharmacists Association xxx (2020) 1e6
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RESEARCH
The effect of targeted insureremandated prescription monitoring on opioid prescribing patterns James N. Fleming*, Jingwen Zhang, David J. Taber, Jenna L. McCauley, Samuel Schumann, Patrick D. Mauldin, Sarah Ball a r t i c l e i n f o
a b s t r a c t
Article history: Received 15 August 2019 Accepted 30 December 2019
Objectives: The purpose of this study was to determine the impact of a mandate from 2 large insurers in South Carolina for mandatory review of the state’s prescription drug monitoring program (PDMP) for controlled substance (CS) prescriptions for more than 5 days’ supply on the proportion of opioid prescriptions for less than or equal to 5 days in a statewide adult population. In addition, changes in the mean morphine milligram equivalents (MME) per day for prescriptions for 5 days or less were described to evaluate prescribing changes. Design, setting and participants: All prescriptions for opioids written for and filled by adults ( 18 years of age) and reported to the PDMP from January 1, 2010, to December 31, 2017, were included in an interrupted time series analysis. Outcome measures: An interrupted time series analysis was performed to determine if there was a significant change in the proportion of opioid prescriptions for less than or equal to 5 days’ supply. Results: Overall opioid prescriptions decreased over the time period by 11.5%, including a decreasing rate of opioid prescriptions for less than or equal to 5 days’ supply. There was no statistical difference in the slope between the pre- and postmandate cohorts (P ¼ 0.077, r2 ¼ 0.951). There was not an identified corresponding increase in the MME per day of prescriptions. Conclusion: Our analysis found that 2 major insurer mandates that occurred in South Carolina in 2016, which required a review of the state PDMP for CS prescriptions for more than 5 days’ supply, did not have a significant impact on the proportion of opioid prescriptions for less than or equal to 5 days’ supply in the statewide population. In addition, we did not find any concern that prescribers attempted to circumvent the requirement by inappropriately adjusting dosing instructions. © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Background Over the past 2 decades, the designation of pain as the “fifth vital sign” has led to more aggressive pain management by physicians, fueling dramatic increases in opioid prescriptions
Disclosure: James N. Fleming and David J. Taber have received unrestricted research grants from Astellas Pharma US, Inc and Veloxis Pharmaceuticals. The authors declare no other relevant conflicts of interest or financial relationships. Funding: The South Carolina Department of Health and Environmental Control (DHEC) Bureau of Drug Control/CDC Prescription Drug Overdose: Prevention for States Program (CDC; 1U17 CD002730). * Correspondence: James N. Fleming, PharmD, BCPS, Medical University of South Carolina, South Carolina College of Pharmacy, 96 Jonathan Lucas, Charleston, SC 29425. E-mail address: fl
[email protected] (J.N. Fleming).
and drug overdose deaths.1-3 In 2017, opioid-related drug overdose deaths accounted for 47,600 (67.8%) of the 70,237 drug overdose deaths in the United States. Although most of these deaths resulted from abuse of heroin and synthetic opioids other than methadone, studies have found that most illicit opioid abuse begins with nonmedical prescription-opioid use, and that more than one-third of opioid-related overdose deaths continue to involve prescription opioids.3-5 Thus, it is incumbent on the medical community to reduce access to prescription opioids in the community. Federal, state, and local governments have responded by implementing laws, programs, and policies intended to mitigate opioid-related harm by reducing the volume of unsafe and unnecessary prescribing. The opioid prescription rates in South Carolina are among the highest in the United States.6 The state has implemented several policies and laws to limit inappropriate opioid
https://doi.org/10.1016/j.japh.2019.12.019 1544-3191/© 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE J.N. Fleming et al. / Journal of the American Pharmacists Association xxx (2020) 1e6
Methods Key Points Study design Background: Mandating use of prescription drug monitoring programs (PDMPs) has been recommended to increase utilization and maximize benefits. Previous analyses of statewide mandated use of PDMPs have shown differing results. Finding: The implementation of a requirement by 2 major insurers within the state of South Carolina to mandate PDMP use for opioid prescriptions more than 5 days' supply did not substantially change the slope of 5 days or less prescriptions over the time period in a statewide population. Further studies on more comprehensive PDMP mandates are needed.
prescribing, including the development of a Prescription Drug Monitoring Program (PDMP) in 2008 and subsequent implementation of several policies regarding its use. BlueCross BlueShield (BCBS) of South Carolina and South Carolina Medicaid, in March 15 and on April 1, 2016, respectively, implemented a requirement that prescribers writing controlled substance (CS) prescriptions for more than 5 days’ supply should review the patient’s CS-prescription history through the PDMP. This requirement rests on a study that found that long-term opioid use increased sharply after the fifth day of prescription-opioid use in opioid-naive surgical patients.7 However, this same study reported that patients who received a cumulative dose of more than 700 morphine milligram equivalents (MME) over the course of their prescriptions were significantly more likely to have long-term opioid use.7 Therefore, if prescribers were to modify their prescribing habits to provide the same amount of opioids with inaccurate instructions to provide the same amount of medication to the patients and yet bypass the requirement to review the PDMP by creating an illusion that it was for a supply of less than or equal to 5 days’, it would diminish or abrogate altogether the true intention of the requirement. The purpose of this analysis was to evaluate the impact of the 2016 insurer mandate, which required PDMP database review for all CS prescriptions of more than 5 days’ supply on the proportion of opioid prescriptions for a supply for 5 days’ or less, and assess the impact of this mandate on the average daily MME of those prescriptions. Objectives The primary aim of this study was to determine the association between 2 major insurer mandates requiring PDMP database review for all CS prescriptions with more than 5 days’ supply and the proportion of opioids that were prescribed for 5 days or less. The secondary aim was to determine the association of the requirements with average MME per day for opioid prescriptions for 5 days or less.
2
Patients All prescriptions for opioids on the product list written for and filled by adults ( 18 years of age) in the state of South Carolina and reported to the PDMP from January 1, 2010, to December 31, 2017, were included in the analysis. Tramadol and propoxyphene prescriptions were excluded. Study data and definitions The South Carolina Reporting & Identification Tracking System (SCRIPTS) database constitutes the PDMP of the state of South Carolina. It was legislated by the South Carolina General Assembly in 2006 and went into effect in 2008 under the maintenance of the Bureau of Drug Control at the South Carolina Department of Health and Environmental Control (DHEC) in response to the prescription drugeabuse crisis. SCRIPTS is intended to help prescribers provide safe and appropriate use of CS. SCRIPTS collects data through daily downloads of Schedule II-IV CS prescriptions and includes state-mandated information on these prescriptions dispensed from any retail or outpatient hospital pharmacy, in addition to any mail-order CS delivered into the state. It does not include long-term care and assisted living dispensing, methadone clinics, or emergency room dispensing of less than a 48-hour supply. Veterans Affairs prescriptions were included in the PDMP from the fourth quarter of 2014. In 2016, the Medical University of South Carolina entered into an agreement with South Carolina DHEC to evaluate the South Carolina PDMP data. Upon receipt of the eight 12-month de-identified SCRIPTS datasets, data quality actions were initiated. Methodologies were developed to build and validate a National Drug Code (NDC) product file of all drug products dispensed between 2010 and 2017 and reported to SCRIPTS. The delivered datasets contained the following information: de-identified unique prescriber number, de-identified unique patient number, age, the first 3 digits of the ZIP code, NDC, product name, quantity of drug dispensed, number of days’ supply, refill status, the date of the prescription, and the date the drug was dispensed. Each medication was considered a “prescription” within the database, regardless of whether multiple prescriptions were written on 1 paper prescription. The product name and NDC from the delivered datasets provided the basis for the product file. To create an analyzable product file, the following fields were added to each unique product name: generic name, strength per unit, unit of measure, MME conversion factor, opioid (yes/no), benzodiazepine (yes/no), muscle relaxant (yes/no), opioid exclusion (yes/no), opioid classification, long-acting/extended-release formulation (yes/no), and Drug Enforcement Administration Class. NDCs formed a many-to-1 grouping with each unique product name. A single NDC from each grouping was selected to crossreference selected fields in the 2013 IBM Micromedex RED BOOK file (IBM Corp, Armonk, NY) and the 2016 Centers for Disease Control and Prevention (CDC) MME conversion file to ensure accuracy of the product name and newly added fields. The CDC MME conversion file was the primary source for obtaining the strength per unit, unit of measure, and MME conversion factor for each opioid product. Updates are
SCIENCE AND PRACTICE Targeted insureremandated prescription monitoring
Figure 1. Percent of opioid prescriptions less than or equal to 5 days’ supply.
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SCIENCE AND PRACTICE J.N. Fleming et al. / Journal of the American Pharmacists Association xxx (2020) 1e6
Figure 2. Average daily morphine milligram equivalents.
as a schedule IV CS in August 2014. Propoxyphene was excluded owing to its withdrawal from the US market in 2010. Our analysis includes all opioids, as opposed to only schedule II opioids, because hydrocodone-based combination products were reclassified from schedule III to schedule II in August 2014. Acetaminophen-codeine combinations with codeine content less than 90 mg remain classified as schedule III and are included in the analysis as well. Prescriptions were divided into pre- and postmandate cohorts. The time point chosen to dichotomize cohorts is April 1, 2016, as both insurer mandates would have been activated within 2 weeks of that time point.
performed annually to identify new products to incorporate into the product file. The following demographic data are available for the patients who received prescriptions: age, medication dispensed, quantity dispensed, number of days’ supply, and geographic variable. Data entered by the pharmacist regarding the prescription and patient at the time of dispensing is fed into the PDMP database. The term “opioids” includes all opioid substances identified as such and on our product list, with the exclusion of tramadol and propoxyphene. Tramadol was excluded owing to the lack of reported prescriptions in the registry before being classified Table 1 Opioid product market share Y (Total N) Butorphanol Codeine þ Dihydrocodeine Fentanyl Hydrocodone Hydromorphone Meperidine Methadone Morphine Oxycodone Oxymorphone Pentazocine Tapentadol
2010 (3,601,705)
2011 (3,864,382)
2012 (3,992,575)
2013 (3,957,105)
2014 (3,879,270)
2015 (3,559,801)
2017 (3,187,629)
0.2% 2.7%
0.1% 2.8%
0.1% 2.5%
0.1% 2.3%
0.1% 2.5%
0.1% 3.9%
0.1% 4.0%
0.1% 4.2%
2.3% 63.3% 1.1% 0.8% 1.1% 3.4% 24.4% 0.4% 0.1% 0.3%
2.2% 63.2% 1.1% 0.7% 1.0% 3.4% 24.2% 0.5% 0.1% 0.6%
2.2% 62.6% 1.2% 0.6% 1.1% 3.5% 24.9% 0.5% 0.1% 0.7%
2.2% 61.8% 1.4% 0.5% 1.0% 3.6% 25.7% 0.6% 0.0% 0.6%
2.3% 59.3% 1.5% 0.4% 1.0% 3.9% 27.5% 0.7% 0.0% 0.6%
2.4% 53.3% 1.6% 0.4% 1.1% 4.5% 31.2% 0.8% 0.0% 0.6%
2.4% 51.7% 1.6% 0.4% 1.1% 4.7% 32.4% 0.9% 0.0% 0.7%
2.4% 50.1% 1.6% 0.3% 1.0% 5.1% 33.5% 0.7% 0.0% 0.8%
Note: Prescriptions for opium and levorphanol were not included in the table due to very low utilization (0%).
4
2016 (3,498,102)
SCIENCE AND PRACTICE Targeted insureremandated prescription monitoring
Figure 3. Percent of prescriptions for immediate release versus prolonged release opioid products.
Statistical analysis For statistical comparisons, prescriptions were divided into pre- and postmandate cohorts, and aggregate data were compared between the 2 groups. To control for secular trends in outcomes not related to the implementation of the mandates, changes in the proportion of opioid prescriptions ( 5 days’ supply) were compared using an interrupted time series (ITS) with a segmented regression analysis. The Durbin-Watson statistic was used to test and correct for serial autocorrelation. An autoregression model was used to test for correlations in data, to estimate autoregressive parameters to be included in the model, and to correct for them to estimate the final parameters. Data were exported from the PDMP database into MS Excel 2016 (Microsoft Corp, Seattle, WA) and statistical analyses were conducted using SAS 9.4 (SAS Institute Inc, Cary, NC). Mean MME was reported in linear trends but not analyzed statistically. Results A total of 29,540,569 opioid prescriptions were filled within the time period, 9,440,210 of which were for a supply of 5 days or less (31.9%). Overall, the annual number of opioid prescriptions declined over the study time period, from 3,601,705 in 2010 to 3,187,629 in 2017 (11.5% decrease). The rate of opioid prescriptions that were for a supply of 5 days or less decreased over the study period (Figure 1). There was no statistical difference in the slope between the pre- and postmandate cohorts (P ¼ 0.077, r2 ¼ 0.951). As shown in Figure 2, the MME per day trended toward a divergence over time between the 2 prescriptionlength cohorts. The MME per day for prescriptions for more than 5 days’ supply largely stayed stable throughout the study period, whereas it trended toward a decrease in the cohort of prescriptions for a supply of 5 days’ or less. The distribution of opioid products dispensed is shown in Table 1. Hydrocodone and oxycodone make up most opioid prescriptions dispensed at all time points. Hydrocodone, meperidine, and pentazocine prescriptions decreased in overall proportion over the study period, whereas oxycodone had the largest increase in market share. Extended-release formulations had a slight increase in use in terms of percentage of all opioid prescriptions, but still made up a small minority of opioid prescriptions in comparison with immediate-release products (Figure 3). There was no indication that the inclusion of Veterans Affairs prescriptions in the PDMP database from the fourth quarter of 2014 had any impact on the results of the study, and the overall prescribing trend continued to decrease even after the addition of this data to the database.
Discussion Our analysis found that the 2 major insurer mandates that occurred in South Carolina in 2016, which required review of the state PDMP for CS prescriptions for more than 5 days’ supply, did not significantly impact the proportion of opioid prescriptions for a supply of 5 days or less in the entire statewide population. In addition, we did not find any concern that prescribers attempted to circumvent the requirement by inappropriately adjusting dosing instructions. The overall number of opioid prescriptions decreased over the analysis timeframe, whereas the population of South Carolina increased from 4,625,364 on April 1, 2010, to 5,024,369 on July 1, 2017.8 This is consistent with the reported opioid prescribing patterns in the United States during this time period.9 Other research collaboratives have demonstrated a lack of impact of PDMPs on opioid prescribing habits in the setting of voluntary use.10 This may, in part, be because of the relatively low voluntary usage of PDMPs. In a nationwide survey, Rutkow et al.11 found that although 72% of physicians were aware of their state PDMPs, only 53% reported ever accessing it, and only 23% reported frequent use. The most common barriers to usage were reported as the amount of time taken to access the website and a lack of easy-to-use information. Mandating use of PDMPs has been recommended to increase utilization and maximize benefits. Interestingly, Bao et al.12 found no impact on prescriptions with a daily MME greater than 120 in 28 states with a comprehensive-use state mandate between 2011 and 2015. These authors did find other benefits of mandated use policies, including reductions in the following: overlapping opioid prescriptions, having 3 or more opioid prescribers, and overlapping opioid and benzodiazepine prescriptions. In contrast to our analysis, Bao et al.12 analyzed the impact of statewide legal mandates on only a subset of nonsenior patient populations with private insurance, whereas our study focused on the impact of insurer mandates that affected a subset of patients within the entire state population. Although their finding of a lack of impact on high-risk opioid prescribing appears to support our results, they also found that there may be benefits in mandatory use policies outside of our primary assessment. In an ITS of Ohio’s mandated use policy, Winstanley et al.13 demonstrated a statistically significant 8.9% decrease in the monthly quantity of opioids and benzodiazepines prescribed. However, the authors also found a modest increase in the mean supply per day and no change in MME per prescription. 5
SCIENCE AND PRACTICE J.N. Fleming et al. / Journal of the American Pharmacists Association xxx (2020) 1e6
This was the result of a state policy mandating PDMP use before writing any opioid or benzodiazepine prescription, and it occurred in a state with high opioid prescribing. Winstanley’s analysis is similar to ours in design and opioid-use rates; however, it significantly differs from our analysis with regard to the intervention. Although Winstanley evaluated a comprehensive state law requiring PDMP use for all opioid and benzodiazepine prescriptions, the intervention studied in our analysis was driven by 2 large insurers within the state and was restricted to opioid prescriptions for more than 5 days’ supply. The potential reasons for our disparate results are the limitations on patients that the mandates influenced, as well as the power of enforcement. For instance, insurer mandates could potentially be bypassed by submitting the prescription for cash instead of seeking insurance reimbursement. In addition, the outcome studied by Winstanley was the overall number of solid dosage forms, whereas we sought to identify changes in opioid prescriptions on the basis of days of supply. It is interesting to note that although the comprehensive state mandate in Ohio led to a significantly decreasing slope in the tablets prescribed, it saw an increase in the number of days of supply in prescriptions and no change in the MME per prescription. In theory, this could mean that it prevented some unnecessary prescriptions; yet, it led prescribers to provide longer therapy for prescriptions they did write, possibly to reduce burdensome interactions with the PDMP. There are some limitations to our analysis. First, South Carolina’s PDMP has been in effect since 2008 and had been available for voluntary use by providers before the insurer mandate. It is unknown if the implementation of the voluntary PDMP had an impact on opioid prescribing before the insurer mandate, but analyses from other states found a lack of impact on opioid-prescribing habits when a PDMP is used voluntarily.10 In addition, our analysis was not limited to policyholders of the insurers that enacted the mandate. However, the 2 insurance providers that enacted the mandate cover a substantial proportion of the population of South Carolina. In South Carolina, BCBS of South Carolina had a market share of 55.6% of all private insurance in 2017.14 Although most South Carolina Medicaid beneficiaries are pediatric, enrollment in adults increased from 296,947 in 2013 to 393,729 in 2017.15 Implications for pharmacy practice The results of our analysis indicate that overall prescriptions for opioids are decreasing in the state of South Carolina. The implementation of a requirement by the 2 major insurers to mandate the use of the PDMP for prescriptions for more than 5 days’ supply did not substantially change the slope over time of the proportion of opioid prescriptions for 5 days’ or less over the study period. More comprehensive or more targeted interventions require study. Conclusion Our statewide analysis of 2 major insurer mandates for PDMP review before writing schedule II CS prescriptions for more than 5 days’ supply did not find a significant change in the proportion of 5 days’ or less supply of opioid prescriptions over time. Because the state of South Carolina has recently implemented a statewide law requiring PDMP review for 6
schedule II CS prescriptions for more than 5 days’ supply, comparative analysis of the impact of insurer versus state mandates within the state will be an important future direction for this research. It would be beneficial to analyze changes in the prescribing habits for patients with high-risk indicators of opioid use. Furthermore, future studies on the differential impact of comprehensive versus limited PDMP mandates are needed. References 1. Morone NE, Weiner DK. Pain as the fifth vital sign: exposing the vital need for pain education. Clin Ther. 2013;35(11):1728e1732. 2. Joint Commission on Accreditation of Healthcare Organizations. Pain standards for 2001. Available at: https://www.jointcommission.org/ assets/1/6/2001_Pain_Standards.pdf. Accessed May 15, 2018. 3. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths d United States, 2010e2015. MMWR Morb Mortal Wkly Rep. 2016;65(50-51):1445e1452. 4. National Institute on Drug Abuse. Prescription opioids and heroin. Available at: https://www.drugabuse.gov/publications/research-reports/ prescription-opioids-heroin. Accessed May 15, 2018. 5. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and opioidinvolved overdose deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018;67(5152):1419e1427. 6. Centers for Disease Control and Prevention. Prescription opioid data. Available at: https://www.cdc.gov/drugoverdose/data/prescribing.html. Accessed May 15, 2018. 7. Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid use - United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66(10):265e269. 8. United States Census Bureau. QuickFacts: South Carolina. Available at: https://www.census.gov/quickfacts/sc. Accessed December 28, 2018. 9. Guy GP Jr, Zhang K, Bohm MK, et al. Vital signs: changes in opioid prescribing in the United States, 2006e2015. MMWR Morb Mortal Wkly Rep. 2017;66(26):697e704. 10. Deyo RA, Hallvik SE, Hildebran C, et al. Association of prescription drug monitoring program use with opioid prescribing and health outcomes: a comparison of program users and nonusers. J Pain. 2018;19(2):166e177. 11. Rutkow L, Turner L, Lucas E, Hwang C, Alexander GC. Most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access. Health Aff (Millwood). 2015;34(3): 484e492. 12. Bao Y, Wen K, Johnson P, Jeng PJ, Meisel ZF, Schackman BR. Assessing the impact of state policies for prescription drug monitoring programs on high-risk opioid prescriptions. Health Aff (Millwood). 2018;37(10): 1596e1604. 13. Winstanley EL, Zhang Y, Mashni R, et al. Mandatory review of a prescription drug monitoring program and impact on opioid and benzodiazepine dispensing. Drug Alcohol Depend. 2018;188:169e174. 14. South Carolina Department of Insurance. Market share report. Accid Health Premiums. Available at https://doi.sc.gov/599/Market-Assistance. Accessed December 28, 2018. 15. South Carolina eHealth Medicaid Statistics. Medicaid enrollment. Available at: http://www.schealthviz.sc.edu/medicaid-enrollment. Accessed December 28, 2018. James N. Fleming, PharmD, FCCP, Adjunct Associate Professor, Department of Pharmacy Services, South Carolina College of Pharmacy, Medical University of South Carolina, Charleston, South Carolina Jingwen Zhang, MS, Instructor, College of Medicine, Medical University of South Carolina, Charleston, South Carolina David J. Taber, PharmD, MS, Professor, Department of Surgery, Medical University of South Carolina; Department of Surgery, Medical University of South Carolina, Charleston, South Carolina Jenna L. McCauley, PhD, Assistant Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina Samuel Schumann, MD, Assistant Professor, College of Medicine, Medical University of South Carolina, Charleston, South Carolina Patrick D. Mauldin, PhD, Professor, College of Medicine, Medical University of South Carolina, Charleston, South Carolina Sarah Ball, PharmD, Assistant Professor, College of Medicine, Medical University of South Carolina, Charleston, South Carolina