Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics: Considerations for Palliative Care Practice

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.

Download Full-text

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

Journal of Medical Regulation ◽

10.30770/2572-1852-103.4.7 ◽

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.

Download Full-text

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

Pain Medicine ◽

10.1093/pm/pnz031 ◽

2019 ◽

Vol 21 (1) ◽

pp. 92-100 ◽

Cited By ~ 1

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 < 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 < 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.

Download Full-text

Opioid Pharmacotherapies for Chronic Pain (DRAFT)

10.1093/med/9780190265366.003.0014 ◽

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.

Download Full-text

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

Drugs ◽

10.2165/11642230-000000000-00000 ◽

2012 ◽

Vol 72 (18) ◽

pp. 2327-2332 ◽

Cited By ~ 14

Author(s):

Sebastiano Mercadante ◽

David Craig ◽

Antonello Giarratano

Keyword(s):

Risk Evaluation ◽

Extended Release ◽

Mitigation Strategy ◽

Long Acting

Download Full-text

The changing landscape of opioid prescribing: long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy

Therapeutics and Clinical Risk Management ◽

10.2147/tcrm.s28764 ◽

2012 ◽

pp. 209 ◽

Cited By ~ 8

Author(s):

Jeffrey A. Gudin

Keyword(s):

Risk Evaluation ◽

Extended Release ◽

Mitigation Strategy ◽

Opioid Prescribing ◽

Long Acting

Download Full-text

The chronic need to improve the management of pain

Pain Research and Management ◽

10.1155/2003/548943 ◽

2003 ◽

Vol 8 (4) ◽

pp. 187-188 ◽

Cited By ~ 2

Author(s):

Eldon Tunks

Keyword(s):

Primary Care ◽

Palliative Care ◽

Primary Care Physicians ◽

Opioid Analgesics ◽

Care Practice ◽

Eligibility Criteria ◽

Chronic Noncancer Pain ◽

Primary Care Doctors ◽

Third Line ◽

Noncancer Pain

In this issue, Drs Morley-Forster, Clark, Speechley and Moulin report on their survey conducted by Ipsos-Reid in June 2001 (pages 189-194). Only physicians who met the eligibility criteria of having written 20 or more prescriptions for moderate to severe pain in the preceding four weeks or having devoted 20% of their time to palliative care were eligible to participate. Sixty-eight per cent of the respondents thought that moderate to severe chronic pain was not well managed in Canada. Despite this opinion, 23% of physicians in palliative care practice and 34% of primary care doctors stated that they would not use opioids to treat moderate to severe chronic noncancer pain even as a third-line treatment after two previous medications had failed. One-quarter to one-third were concerned about the potential for addiction, and a smaller percentage reported concern about the potential for patient abuse and/or misuse, and side effects. Fear of a College audit resulting in the loss of their medical licence was cited by 10% of primary care physicians. When asked what obstacle hindered their use of strong opioid analgesics, an unexplained 10% of palliative care doctors and 14% of primary care doctors answered "nothing in particular".

Download Full-text

Retrospective analysis of pharmacist interventions in an ambulatory palliative care practice

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155215607089 ◽

2016 ◽

Vol 22 (6) ◽

pp. 757-765 ◽

Cited By ~ 22

Author(s):

Joseph D Ma ◽

Victor Tran ◽

Carissa Chan ◽

William M Mitchell ◽

Rabia S Atayee

Keyword(s):

Palliative Care ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Care Practice ◽

Cancer Type ◽

Pharmacist Interventions ◽

Medication Dose ◽

Long Acting ◽

Medication Changes

Background We have previously reported the development of an outpatient palliative care practice under pharmacist–physician collaboration. The Doris A. Howell Service at the University of California, San Diego Moores Cancer Center includes two pharmacists who participate in a transdisciplinary clinic and provide follow-up care to patients. Objective This study evaluated pharmacist interventions and patient outcomes of a pharmacist-led outpatient palliative care practice. Methods This was a retrospective data analysis conducted at a single, academic, comprehensive cancer center. New (first visit) patient consultations were referred by an oncologist or hematologist to an outpatient palliative care practice. A pharmacist evaluated the patient at the first visit and at follow-up (second, third, and fourth visits). Medication problems identified, medication changes made, and changes in pain scores were assessed. Results Eighty-four new and 135 follow-up patient visits with the pharmacist occurred from March 2011 to March 2012. All new patients ( n = 80) were mostly women ( n = 44), had localized disease ( n = 42), a gastrointestinal cancer type ( n = 21), and were on a long-acting ( n = 61) and short-acting ( n = 70) opioid. A lack of medication efficacy was the most common problem for symptoms of pain, constipation, and nausea/vomiting that was identified by the pharmacist at all visits. A change in pain medication dose and initiation of a new medication for constipation and nausea/vomiting were the most common interventions by the pharmacist. A statistically significant change in pain score was observed for the third visit, but not for the second and fourth visits. Conclusions A pharmacist-led outpatient palliative care practice identified medication problems for management of pain, constipation, and nausea/vomiting. Medication changes involved a change in dose and/or initiating a new medication. Trends were observed in improvement and stabilization of pain over subsequent clinic visits.

Download Full-text