Frank Peacock, MD, FACEP, FACC Professor of Emergency Medicine, Associate Chair Research Director, Department of Emergency Medicine Baylor College of Medicine Houston, Texas

Significant Reduction in Overall Emergency Department Costs and Patient Length of Stay When Treating Opioid-Induced Constipation with FDA-Approved Medications

MedicalResearch.com Interview with:

Frank Peacock, MD, FACEP, FACC Professor of Emergency Medicine, Associate Chair Research Director, Department of Emergency Medicine Baylor College of Medicine Houston, Texas

Dr. Peacock

Frank Peacock, MD, FACEP, FACC
Professor of Emergency Medicine, Associate Chair
Research Director, Department of Emergency Medicine
Baylor College of Medicine
Houston, Texas

MedicalResearch.com: What is the background for this study?

Response: Emergency medicine (EM) physicians, like myself, are always looking for ways to improve the patient experience. Often times, we will encounter a patient in the emergency department (ED) who is presenting with one of the most common side effects of opioids, which is opioid-induced constipation (OIC). OIC impacts 40-80% of patients on long-term opioid therapy, and may lead to emergency room visits which are associated with a significant burden on patients and the healthcare system. We wanted to compare the impact of treating OIC patients with FDA-approved prescription medications for OIC versus the impact of not treating OIC patients with an FDA-approved prescription medication for OIC in the ED setting to better understand the impact to overall ED costs and the length of stay for a hospitalized patient.

MedicalResearch.com: What are the main findings? What is the potential impact of these data on the medical community?

Response: The study was a retrospective encounter-based analysis of adult patients with opioid-induced constipation with an ED encounter. It looked at a broad category of healthcare resource utilization (e.g., likelihood of being discharged home, inpatient admission, length of stay) and healthcare costs during the ED encounter and during the 30-day post discharge period. The poster titled, “Impact of PAMORA use in the ED on Healthcare Resource Utilization and Costs Among Patients with OIC” was presented at the Emergencies In Medicine Meeting in Park City, Utah.

Since opioid-induced constipation patients may present in the ED setting with various comorbidities, demographics and are subject to different diagnostic procedures like X-Ray and CT-Scan, we had to find a way to compare these patients so that the actual effect of treatment could be calculated. This was achieved utilizing entropy balancing. The study found that patients who received an FDA-approved prescription medication for OIC in the ED were more likely to be discharged home, less likely to be hospitalized, and if admitted, more likely to have had a shorter inpatient stay than those who did not receive an FDA-approved prescription medication for OIC. The results were driven by patients who received RELISTOR® (methylnaltrexone bromide) subcutaneous injection, which represented over 95% of all patients treated with a peripherally acting mu opioid receptor antagonist (PAMORA) in this study. In addition, in this study the research also found that patients who received RELISTOR in the ED cost the healthcare system an average of $1,173 less than patients who did not receive an FDA-approved prescription medication for OIC in the ED setting.

One of the most important things for me as an ED physician is patient treatment time. Based on my experience, patients coming to the ED with opioid-induced constipation may not be treated with effective pharmacologic or procedural options, which may result in some staying in the hospital longer than necessary and increasing the time residents and physicians may spend on unnecessary procedures. I have seen patients undergoing a battery of tests like X-rays, CTs and more to rule out other conditions, which were increasing the costs of care. To my knowledge, there has not been research published in an ED journal that discusses FDA-approved prescription medications for opioid-induced constipation and their impact on treating patients with OIC once they are admitted to the ED. In this study, the overall cost savings and reduction in length of stay was significant.

MedicalResearch.com: What should readers take away from your report?

Response: The odds of an ED visit or hospitalization are significantly higher for patients with chronic pain arising from serious conditions such as cancer who are taking opioids and experiencing opioid-induced constipation,. This research provides insight into how we can potentially reduce healthcare costs and improve care for these patients.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: As an EM physician, my goal is to reduce the amount of time patients spend in the ED and treat their OIC. In publishing this research, my goal is to motivate other health care providers in the ED and outpatient setting to explore the use of FDA-approved prescription medications for OIC for appropriate adult chronic pain patients on opioid therapy who are experiencing OIC.

MedicalResearch.com: Is there anything else you would like to add?

Response: This study was funded by Bausch Health US, LLC; RELISTOR is distributed in the U.S. by Salix Pharmaceuticals, which is a division of Bausch Health US, LLC. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, and the production of the poster.

INDICATIONS

RELISTOR® is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

IMPORTANT SAFETY INFORMATION

  • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
  • Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
  • Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
  • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
  • A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
  • In the clinical studies, the most common adverse reactions were:

OIC in adult patients with chronic non-cancer pain

    • RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
    • RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).

OIC in adult patients with advanced illness

    • RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%), flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

Citation: Abstract presented at Emergencies In Medicine Meeting 2021

Peripherally Acting Mu-opioid Receptor Antagonist (PAMORA) use in the Emergency Department on Healthcare Resource Utilization and Costs Among Patients with Opioid Induced Constipation

Research supported by Salix Pharmaceuticals

[1] Argoff C. E. (2020). Opioid-induced Constipation: A Review of Health-related Quality of Life, Patient Burden, Practical Clinical Considerations, and the Impact of Peripherally Acting μ-Opioid Receptor Antagonists. The Clinical journal of pain, 36(9), 716–722. https://doi.org/10.1097/AJP.0000000000000852

[1] Bell, T. J., Panchal, S. J., Miaskowski, C., Bolge, S. C., Milanova, T., & Williamson, R. (2009). The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain medicine (Malden, Mass.), 10(1), 35–42. https://doi.org/10.1111/j.1526-4637.2008.00495.x

[1] Peacock, F. (2021). Impact of Peripherally Acting Mu-opioid Receptor Antagonist (PAMORA) use in the Emergency Department on Healthcare Resource Utilization and Costs Among Patients with Opioid Induced Constipation.

[1] Fine, P. G., Chen, Y. W., Wittbrodt, E., & Datto, C. (2019). Impact of opioid-induced constipation on healthcare resource utilization and costs for cancer pain patients receiving continuous opioid therapy. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 27(2), 687–696. https://doi.org/10.1007/s00520-018-4366-z

[1] Wan, Y., Corman, S., Gao, X., Liu, S., Patel, H., & Mody, R. (2015). Economic burden of opioid-induced constipation among long-term opioid users with noncancer pain. American health & drug benefits, 8(2), 93–102.

May 24, 2021 @ 9:47 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Argoff C. E. (2020). Opioid-induced Constipation: A Review of Health-related Quality of Life, Patient Burden, Practical Clinical Considerations, and the Impact of Peripherally Acting μ-Opioid Receptor Antagonists. The Clinical journal of pain, 36(9), 716–722. https://doi.org/10.1097/AJP.0000000000000852

Bell, T. J., Panchal, S. J., Miaskowski, C., Bolge, S. C., Milanova, T., & Williamson, R. (2009). The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain medicine (Malden, Mass.), 10(1), 35–42. https://doi.org/10.1111/j.1526-4637.2008.00495.x

Peacock, F. (2021). Impact of Peripherally Acting Mu-opioid Receptor Antagonist (PAMORA) use in the Emergency Department on Healthcare Resource Utilization and Costs Among Patients with Opioid Induced Constipation.

Fine, P. G., Chen, Y. W., Wittbrodt, E., & Datto, C. (2019). Impact of opioid-induced constipation on healthcare resource utilization and costs for cancer pain patients receiving continuous opioid therapy. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 27(2), 687–696. https://doi.org/10.1007/s00520-018-4366-z

Wan, Y., Corman, S., Gao, X., Liu, S., Patel, H., & Mody, R. (2015). Economic burden of opioid-induced constipation among long-term opioid users with noncancer pain. American health & drug benefits, 8(2), 93–102.

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May 24, 2021 @ 9:47 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.