Assessing the impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategies on opioid prescription volume

2017 ◽  
Vol 13 (3) ◽  
pp. 157 ◽  
Author(s):  
Victoria Divino, BA ◽  
M. Soledad Cepeda, MD, PhD ◽  
Paul Coplan, ScD, MBA, MPH ◽  
Jean-Yves Maziere, MD, PhD ◽  
Yingli Yuan, PhD ◽  
...  
Keyword(s):  
Risk Evaluation ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Patient Characteristics ◽  
Mitigation Strategies ◽  
Opioid Prescription ◽  
Long Acting ◽  
The Impact ◽  
Prescription Volume

Objective: The Food and Drug Administration approved the extended-release/long-acting (ER/LA) opioid analgesics risk evaluation and mitigation strategies (REMS) in July 2012 to educate healthcare providers and patients about safe and appropriate opioid analgesic use. The authors evaluated the impact of the REMS on ER/LA opioid analgesic utilization, overall and stratified by patient characteristics and prescriber type associated with greater expected need for analgesia. Design: Retrospective repeated cross-sectional study. QuintilesIMS's National Prescription Audit™ and LifeLink™ patient-level longitudinal prescription databases measured prescription volumes, projected to national estimates.Main Outcome Measures: Changes were assessed in ER/LA opioid analgesic prescriptions dispensed from the 2-year pre-REMS implementation (July 2010 to June 2012) to the 18-month post-REMS implementation (July 2013 to December 2014) periods (with 12-month transitional implementation period in between).Results: Average quarterly ER/LA opioid prescription volume significantly decreased by 4.3 percent from Preimplementation to the Active Period (5.58 vs 5.34 million, p < 0.001). Differences in prescription volume change were observed between age, gender, and payer types. Prescription volume either significantly decreased or remained stable from Preimplementation to the Active Period among most provider specialties evaluated. The largest volume decreases were observed for dentists (–48.5 percent) and emergency medicine specialists (–25.5 percent) (both p < 0.001). The largest increases were observed for nurse practitioners (+33.7 percent) and physician assistants (+31.2 percent; both p < 0.001), whose overall prescribing of nonopioid medications also increased. Conclusions: A significant decrease in dispensed ER/LA opioid prescriptions was observed following REMS implementation compared to Preimplementation. The impact on volume varied by patient characteristics and prescriber specialty. The REMS program, in conjunction with other healthcare policies and initiatives, likely influenced these observations.

scholarly journals Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS):

2017 ◽  
Vol 103 (4) ◽  
pp. 7-16
Author(s):  
Daniel U. Rabin ◽  
Heather K. Tarbox ◽  
Lois Colburn ◽  
Kelly C. Alfred
Keyword(s):  
Health Care Providers ◽  
Risk Evaluation ◽  
Extended Release ◽  
Clinical Decision Making ◽  
Opioid Analgesics ◽  
The United States ◽  
Mitigation Strategy ◽  
Care Providers ◽  
Long Acting ◽  
The Impact

In response to the proliferation and abuse of opioids in the United States, the U.S. Food and Drug Administration (FDA) recently required manufacturers of extended-release and long-acting (ER/LA) opioid analgesics to provide education for prescribers of these medications through an FDA-approved risk management program. As a part of its Risk Evaluation and Mitigation Strategy (REMS), the FDA provided a blueprint for content to help accredited continuing medical education (CME) providers develop educational modules for prescribers. The University of Nebraska Medical Center (UNMC), the Federation of State Medical Boards (FSMB), the FSMB Foundation, The France Foundation, and CECity worked collaboratively to create “Extended-Release and Long-Acting Opioid Analgesics,” a prescriber education program aligned with the FDA blueprint, comprised of live meetings and web-based enduring activities that spanned April 2014 to February 2016. A total of 4,535 health care providers participated in the live and enduring REMS CME activities and completed evaluations of these activities. The evaluations were analyzed to learn more about the impact of the content on prescribers' knowledge and clinical decision-making. Results were similar for live and enduring activities. Participant-knowledge increased by 22 percentage points. Several competence measures suggest that learners returned to practice with more confidence, and 83% declared specific practice changes they planned to make to improve patient assessment and care. More than one-third of the evaluation respondents felt there were no barriers to making intended practice changes. More than 95% of the respondents said the activity increased their ability to apply knowledge, skills, and judgment in practice. Analysis suggests that live and enduring educational activities, following the FDA REMS blueprint, can impact prescriber attitudes and future care-decisions related to ER/LA opioid analgesics. These results justify additional efforts to involve more participants in these REM activities.

scholarly journals Changes in Mortality Involving Extended-Release and Long-Acting Opioids After Implementation of a Risk Evaluation and Mitigation Strategy

Pain Medicine ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. 92-100 ◽  
Author(s):  
Joshua C Black ◽  
Gabrielle E Bau ◽  
Travis Rosen ◽  
M Soledad Cepeda ◽  
Gregory P Wedin ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Risk Evaluation ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Mortality Rates ◽  
Mitigation Strategy ◽  
Medical Examiner ◽  
Significant Heterogeneity ◽  
Long Acting

Abstract Objective To assess changes in mortality rates in extended-release and long-acting (ER/LA) opioid analgesics after the implementation of the Risk Evaluation and Mitigation Strategy (REMS). Setting All drug poisoning deaths in three states: Florida, Oregon, and Washington. Data were obtained through state vital records offices and the Researched Abuse, Diversion and Addiction-Related Surveillance System Medical Examiner Program. Methods Using cause-of-death literal text from death certificates, individual opioid active pharmaceutical ingredients (APIs) involved in each death were identified using rules-based natural language processing. Population-adjusted and prescriptions dispensed–adjusted mortality rates were calculated for all ER/LA opioid analgesic and individual opioid APIs. Rates before and after implementation of the REMS were compared. Rate changes were compared with rates from two APIs with little or no inclusion in the REMS: benzodiazepines and hydrocodone. Results The mean ER/LA opioid analgesic population-adjusted mortality rate significantly decreased in all three states (FL: P = 0.003; OR: P = 0.003; WA: P &lt; 0.001). Mortality rates for benzodiazepines and hydrocodone also decreased and were not statistically different. Significant heterogeneity in mortality rates of individual opioids was observed between the three states. When adjusted for prescription volume, the ER/LA opioid analgesic mortality rate decreased in all three states, but was significant only for Washington (P &lt; 0.001). Conclusions The population-adjusted mortality rate of ER/LA opioid analgesics has decreased in three states. Notably, the contributions to mortality rates by individual opioid analgesics were not uniform across the three states in this study. However, these changes were not generally distinct from changes in mortality rates where comparator substances were involved.

Changes in misuse and abuse of prescription opioids following implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

2017 ◽  
Vol 26 (9) ◽  
pp. 1061-1070 ◽  
Author(s):  
Becki Bucher Bartelson ◽  
M. Claire Le Lait ◽  
Jody L. Green ◽  
M. Soledad Cepeda ◽  
Paul M. Coplan ◽  
...  
Keyword(s):  
Risk Evaluation ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Mitigation Strategy ◽  
Prescription Opioids ◽  
Long Acting

scholarly journals Candidate Metrics for Evaluating the Impact of Prescriber Education on the Safe Use of Extended-Release/Long-Acting (ER/LA) Opioid Analgesics

Pain Medicine ◽  
2014 ◽  
Vol 15 (9) ◽  
pp. 1558-1568 ◽  
Author(s):  
Mary E. Willy ◽  
David J. Graham ◽  
Judith A. Racoosin ◽  
Rajdeep Gill ◽  
Garner F. Kropp ◽  
...  
Keyword(s):  
Extended Release ◽  
Opioid Analgesics ◽  
Long Acting ◽  
The Impact

Opioid tolerance and urine drug testing among initiates of extended-release or long-acting opioids in Food and Drug Administration's Sentinel System

2017 ◽  
Vol 13 (5) ◽  
pp. 315 ◽  
Author(s):  
Marc R. Larochelle, MD, MPH ◽  
Noelle M. Cocoros, DSc, MPH ◽  
Jennifer Popovic, DVM, MA ◽  
Elizabeth C. Dee, MPH ◽  
Cynthia Kornegay, PhD ◽  
...  
Keyword(s):  
Drug Testing ◽  
Extended Release ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Opioid Tolerance ◽  
Transdermal Fentanyl ◽  
Urine Drug Testing ◽  
Urine Drug ◽  
Long Acting ◽  
Tolerance Criteria

Objective: A risk evaluation and mitigation strategy for extended-release and long-acting (ER/LA) opioid analgesics was approved by the Food and Drug Administration in 2012. Our objective was to assess frequency of opioid tolerance and urine drug testing for individuals initiating ER/LA opioid analgesics.Design: Retrospective cohort study.Setting: Sentinel, a distributed database with electronic healthcare data on >190 million predominantly commercially insured members.Patients, participants: Members under age 65 initiating ER/LA opioid analgesics between January 2009 and December 2013.Main outcome measure(s): We examined the proportion of opioid-tolerantonly ER/LA opioid analgesic initiates meeting tolerance criteria: receipt of ≥30 mg oxycodone equivalents per day in 7 days prior to the first opioid-tolerant-only dispensing. We separately examined the proportion of new users of extended-release oxycodone (ERO) and other ER/LA opioid analgesics with a claim for a urine drug test in the 30 days prior to, and separately for the 183 days after, dispensing.Results: We identified 79,824 ERO, 7,343 extended-release hydromorphone, and 91,778 transdermal fentanyl opioid-tolerant-only episodes. Tolerance criteria were met in 64 percent of ERO, 64 percent of extended-release hydromorphone and 40 percent of transdermal fentanyl episodes. We identified 210,581 incident ERO and 311,660 other ER/LA opioid analgesic episodes. Use of urine drug testing for ERO compared with other ER/LA opioid analgesics was: 4 percent vs 14 percent respectively in the 30 days prior to initiation and 9 percent vs 23 percent respectively in the 183 days following initiation.Conclusions: These results suggest potential areas for improving appropriate ER/LA opioid analgesic prescribing practices.

Opioid Pharmacotherapies for Chronic Pain (DRAFT)

2018 ◽  
Author(s):  
Thien C. Pham ◽  
Courtney Kominek ◽  
Abigail Brooks ◽  
Jeffrey Fudin
Keyword(s):  
Chronic Pain ◽  
Extended Release ◽  
Opioid Analgesics ◽  
Chronic Pain Management ◽  
Opioid Use ◽  
Daily Dose ◽  
Long Acting ◽  
Conversion Tool ◽  
Morphine Equivalent

Chronic pain management employing opioids is divided into subtopics, including: risk–benefit balance; a review of the mode of action of opioid analgesics (Chap. 8); the suitability of synthetic opioids for neuropathic pain; endocrinopathy proceeding from opioid use; the use of the morphine-equivalent daily dose as a conversion tool for managing multiple opioids; the place of extended-release and long-acting opioids; current technology in abuse deterrence; and an overview of the challenges entailed in prescribing. This last section details the complex components of a decision to prescribe opioids for chronic pain. A table is provided of the classification of common opioid analgesics and their duration of activity. A text box gives the table of contents of Appendix B, supportive tables and figures therein for this chapter; there is also a text box listing additional resources.

US Food and Drug Administrationʼs Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioids

Drugs ◽  
2012 ◽  
Vol 72 (18) ◽  
pp. 2327-2332 ◽  
Author(s):  
Sebastiano Mercadante ◽  
David Craig ◽  
Antonello Giarratano
Keyword(s):  
Risk Evaluation ◽  
Extended Release ◽  
Mitigation Strategy ◽  
Long Acting

scholarly journals Frequency of Early Refills for Opioids in the United States

Pain Medicine ◽  
2020 ◽  
Vol 21 (9) ◽  
pp. 1818-1824
Author(s):  
David M Kern ◽  
M Soledad Cepeda ◽  
Maribel Salas ◽  
Syd Phillips ◽  
Matthew H Secrest ◽  
...  
Keyword(s):  
Patient Characteristics ◽  
Immediate Release ◽  
The United States ◽  
Prescription Opioid ◽  
Opioid Prescription ◽  
National Drug ◽  
One Year ◽  
Long Acting ◽  
Opioid Users

Abstract Objective Refilling an opioid prescription early is an important risk factor of prescription opioid abuse and misuse; we aimed to understand the scope of this behavior. This study was conducted to quantify the prevalence and distribution of early refills among patients prescribed opioids. Methods We conducted a retrospective cohort study utilizing dispensed prescription records. Patients filling one or more prescription opioids were identified and followed for one year. Early refills were defined as having a second prescription filled ≥15% early relative to the days’ supply of the previous prescription for the same opioid (according to the National Drug Code [NDC]). The distribution of the number of early refills and patient characteristics were assessed. Results A total of 60.6 million patients met the study criteria; 28.8% had two or more opioid prescriptions for the same opioid during follow-up. Less than 3% of all patients receiving an opioid had an early refill. Approximately 10% of those with two or more opioid prescriptions for the same drug had an early refill. For patients with multiple fills (N = 1.5 million with extended-release long-acting [ER/LA] opioids; N = 17.1 million with immediate-release short-acting [IR/SA] opioids), early refills were more common among patients with an ER/LA opioid (18.5%) compared with an IR/SA opioid (8.7%). Three-quarters of patients with an early refill had only one (70.9% and 78.4% for ER/LA and IR/SA, respectively). Conclusion Refilling an opioid prescription with the same opioid early is an infrequent behavior within all opioid users, but more common in ER/LA users. Patients who refilled early tended to do so just once.

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