Posters

Poster – Evaluation of Strategies to Enhance Hospice Patient and Family’s Knowledge
and Confidence of Commonly Used Medications

Abby Stevens, PharmD^1,2, Ryan Costantino PharmD, MS, BCPS, BCGP¹, Mary Lynn McPherson, PharmD, MA, MDE, BCPS^1
1 University of Maryland School of Pharmacy, ² MedStar Health

Background:

Approximately 50% of the patient deaths of those enrolled in hospice care in 2018, died at home.¹
• Twenty-three percent of informal caregivers (IFC) caring for patients in home hospice agreed it is difficult to decide which
analgesic to give, and 21% agreed it is difficult to decide what dose of analgesic medication to administer.²
• The Consumer Assessment of Healthcare Providers and Systems (CAHPS) hospice survey is distributed by the Centers
for Medicare and Medicaid (CMS) to informal caregivers after the death of a hospice patient to evaluate eight domains of
care: communication with family, getting timely help, treating patient with respect, emotional and spiritual support, help for
pain and symptoms, training family to care for patient, rating of the hospice, willingness to recommend the hospice.³
• Infographics provide complex information to various audiences in an easy to comprehend format with the use of pictures and
images.⁴

Keywords: hospice, caregiver, patient, family, palliative medicine, palliative care

Presentation Slide Handout: Poster Presentation PDF

DOI: 10.5055/bupe.21.pp.0095

References:

1. NHPCO Facts and Figures 2020 Edition. National Hospice and Palliative
Care Organization. 2020 Aug 20.
2. J Pain Symptom Manage. 2004;27(2):114-124.
3. CAHPS® Hospice Survey | CMS. Accessed April 11, 2021.
4. Chin Med J (Engl). 2018;131(20):2514-2517.

Poster – Limited Observational Case Study Documenting The Transition of Patients
Off Medication-Assisted Treatment With The Use of XR-Buprenorphine

Linda Young, DNP
Owner/Provider, Compassionate Care, Inc., North Smithfield, RI 02896

Abstract:

This was a limited observational case study, documenting the reported withdrawal symptoms of three Medication-assisted treatment (MAT) patients, after the cessation of subcutaneously injected XR (extended release) buprenorphine. The participants were two females ages 39 (participant A) and 37 (participant B) and one male 40 (participant C) years old. Each participant had a diagnosis of opioid use disorder (OUD), had at least three years of documented opioid cessation, were stable in all aspects of their lives and were requesting to be transitioned off MAT. The participants were given injections of XR-buprenorphine for six consecutive months and then the treatment was discontinued. Each participant met with the clinician monthly and a COWS (clinical opioid withdrawal scale) and a urine for toxicology was obtained. The female participants were followed for twelve and eleven months respectively and the male for nine months. The results of the COWS scores were zero (0) for all consecutive months of the study and the urine tox screens were negative for opioid use for all consecutive months, for all three participants. Although the results of this case study are limited, they do indicate that the use of XR-buprenorphine to transition patients off MAT may be a novel and innovative way to assist stable patients with reclaiming their previously opioid free lives.

Keywords: Medication-assisted treatment, XR-buprenorphine, opioid use disorder, buprenorphine

Presentation Slide Handout: Poster Presentation Handouts

DOI: 10.5055/bupe.21.pp.0090

Poster – A randomised controlled study to compare analgesic efficacy of sublingual buprenorphine
versus intravenous tramadol in patients undergoing mastectomy

Krishna Sumanth Dokku, Srinivasa Shyam Prasad Mantha, Abhijit Nair, Basanth Kumar Rayani
Department of Anaesthesiology, Basavatarakam Indo- American Cancer Hospital and Research Institute, Hyderabad, India

Abstract:

Sublingual (SL) buprenorphine has been used by researchers to manage acute postoperative pain. In this study, we compared analgesic efficacy of SL buprenorphine to intravenous tramadol in managing postoperative pain after mastectomy.

Postmastectomy pain syndrome (PMPS) is a chronic neuropathic pain observed in women who undergo breast surgery. Poorly managed postoperative pain after breast surgery is one of the important causes of PMPS. Buprenorphine is available for clinical use in the form of sublingual (SL) tablets which have been used for managing acute postoperative pain with reasonable success.

Presentation Slide Handout: Poster Presentation

DOI: 10.5055/bupe.21.pp.0085

Poster – The Effects of CARA on Buprenorphine prescribing patterns amongst providers

Jonathan Liu MD, Henry Young MD

Abstract:

Background: Buprenorphine is a mainstay of FDA approved Medication Assisted Treatment (MAT) used to treat OUD. Access remains a barrier to widespread treatment.

Purpose: In 2016, CARA sought to increase MAT access by allowing waivered Nurse Practitioners (NPs) and Physician Assistants (PAs) to prescribe buprenorphine for MAT. NP and PA written prescriptions have increased annually alongside the number of licensed providers. Unclear is whether increasing prescriptions can be attributed to each provider prescribing more, an increase in providers, or both. We examined the effects of CARA on prescribing patterns among advanced practice providers.

Procedures: The number of buprenorphine prescriptions written in the US by NPs, PAs, and physicians from 2012-2017 was collected using the IQVIA database, which represents 92% of all US retail prescriptions. The number of providers was obtained from the providers’ respective licensing agencies. Descriptive statistics were used to analyze the data. Prescriptions per provider for PAs, NPs and physicians and physicians increased 8%, 28% and 4%, the year CARA took effect, compared to 14%, 19% and 9% the year before.

Conclusions: Total buprenorphine prescriptions and buprenorphine prescriptions per provider increased annually for all provider types. However, the prescriptions per provider increased for NPs, but decreased for PAs the year CARA was implemented.

Presentation Slide Handout: Poster Presentation PDF

DOI: 10.5055/bupe.21.pp.0080

Poster –

Buprenorphine Buccal Film for Chronic Low Back Pain in 2 Double-blind, Placebo-controlled, Randomized Withdrawal Trials:
A Pooled Analysis of Subgroups Based on Baseline Pain Severity

Mancia Ko, PharmD¹; Gary Cutter, PhD^2,3; Todd Kunkel, PharmD¹

¹ BioDelivery Sciences International, Inc., Raleigh, NC, USA; ² Pythagoras, Inc., Birmingham, AL, USA; ³ University of Alabama at Birmingham School of Public Health, Department of Biostatistics, Birmingham, AL, USA

Buprenorphine Buccal Film (BELBUCA®)

• —Buprenorphine is an atypical opioid and a partial µ-opioid receptor agonist, with demonstrated efficacy as an analgesic and favorable safety properties that may provide an improved risk-benefit profile relative to other opioids1
• —As with all Schedule II long-acting opioids, buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate2
• —Two previous phase 3 clinical trials established the efficacy of BBF for treating chronic low back pain in opioid-naive3 and opioid-experienced4 subjects (ClinicalTrials.gov NCT01633944 and NCT01675167, respectively)
• —Both studies used an enriched enrollment, randomized withdrawal design that consisted of an open-label BBF titration phase followed by a randomized, double-blind phase in which subjects either continued treatment with BBF or were switched to placebo3,4 (Figure 1)
• —After 12 weeks of double-blind treatment, mean average daily pain scores worsened significantly less from baseline in subjects who continued use of BBF than in those who switched to placebo3,4
• —Subjects in the BBF group also had significantly lower pain scores at Week 1 and at all subsequent time points through Week 123,4

Objective

—This post hoc analysis pooled data from both aforementioned clinical trials to characterize further the efficacy of BBF on the basis of baseline pain severity

Presentation Slide Handouts: Poster Presentation

DOI: 10-5055-bupe-21-pp-0070

References:

1.Marshall B, et al. Pain Manag. 2019;9(2):131-138.
2.Webster LR, et al. Adv Ther. 2020;37(11):4685-4696.
3.United States Drug Enforcement Administration. Drug scheduling. https://www.dea.gov/drug-scheduling.
4.Belbuca. Package insert. BioDelivery Sciences International, Inc.; 2019.
5.Webster LR, et al. Pain Med. 2016;17(6):1112-1130.
6.Kopecky EA, et al. J Clin Pharmacol. 2017;57(4):500-512.
7.Shram MJ, et al. J Clin Psychopharmacol. 2015;35(3):242-9.

Poster – Pharmacokinetic and Pupillometry Outcomes from a Phase 1 Placebo-controlled Trial
to Compare the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride

Lynn Webster, MD¹; Jacqueline Cater, PhD²; Thomas Smith, MD³

¹ Center for U.S. Policy, Salt Lake City, UT, USA; ² ICON plc, Philadelphia, PA, USA; ³ BioDelivery Sciences International, Inc., Raleigh, NC, USA

Background

• —The opioid crisis has led to increased concern about the safety of opioids administered for chronic pain, especially regarding abuse and respiratory depression–associated death1
• —As a partial μ-opioid receptor agonist, buprenorphine has unique properties that distinguish it from full μ-opioid receptor agonists
  • Buprenorphine is classified as a Schedule III drug because it has a lower abuse potential than full µ-opioid receptor agonists2,3
• —Buprenorphine buccal film (BELBUCA®, BBF) is approved by the US Food and Drug Administration for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate4
• —In this phase 1 study, evaluation of the primary endpoint revealed immediate-release oxycodone administration led to a significant, dose-dependent decrease in respiratory drive, whereas BBF did not (ClinicalTrials.gov Identifier: NCT03996694)
• —The pharmacokinetic and pupillometry outcomes presented here were chosen because of their relevance for respiratory safety and potential risk for abuse
  • The abuse quotient (AQ) is a quantitative measure of pharmacokinetic parameters to compare an aspect of abuse potential across opioids5
  • oPrevious studies have shown a relationship between pupil constriction and “drug liking” in the context of opioid abuse6,7

Purpose

—Here we report secondary outcomes from the aforementioned phase 1 clinical trial, including effects of BBF and immediate-release oral oxycodone on pharmacokinetic, and pupillometry assessments.

Presentation Slide Handouts: Poster Presentation

DOI: 10-5055-bupe-21-pp-0065

References:

1.Marshall B, et al. Pain Manag. 2019;9(2):131-138.
2.Webster LR, et al. Adv Ther. 2020;37(11):4685-4696.
3.United States Drug Enforcement Administration. Drug scheduling. https://www.dea.gov/drug-scheduling.
4.Belbuca. Package insert. BioDelivery Sciences International, Inc.; 2019.
5.Webster LR, et al. Pain Med. 2016;17(6):1112-1130.
6.Kopecky EA, et al. J Clin Pharmacol. 2017;57(4):500-512.
7.Shram MJ, et al. J Clin Psychopharmacol. 2015;35(3):242-9.

Poster – Respiratory Outcomes from a Phase 1, Placebo-controlled Trial to Compare the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride

Lynn Webster, MD¹; Jacqueline Cater, PhD²; Thomas Smith, MD³

¹ Center for U.S. Policy, Salt Lake City, UT, USA; ² ICON plc, Philadelphia, PA, USA; ³ BioDelivery Sciences International, Inc., Raleigh, NC, USA

Background

• —Respiratory depression is the leading cause of death due to opioid overdose1
• —Inhibition of respiratory drive (ie, the ability of neuronal respiratory centers to control and regulate ventilation) is a major contributor to respiratory depression2
• —Buprenorphine is a partial µ-opioid receptor agonist that exhibits a ceiling effect for respiratory depression when administered intravenously, unlike full µ-opioid receptor agonists (eg, morphine, oxycodone, fentanyl)3,4
• —Partial agonism only refers to receptor-level activation and not analgesic efficacy, as buprenorphine provides analgesic efficacy comparable to that of full µ-opioid receptor agonists5
• −This partial agonism at the µ-opioid receptor, together with antagonism at the κ and δ opioid receptors and agonism at the nociceptin receptor (formerly known as opioid receptor-like 1 or ORL-1), may play a role in limiting common opioid-related adverse events (AEs) such as respiratory depression

Purpose

—This study compared the effects of buprenorphine buccal film (BBF; BELBUCA®) with the effects of immediate-release oral oxycodone on respiratory outcomes to differentiate impact of a partial µ-opioid receptor agonist (ie, BBF) from that of a full µ-opioid receptor agonist (ie, oxycodone)

Presentation Slide Handouts: Poster Presentation

DOI: 10-5055-bupe-21-pp-0060

References:

1. White JM, Irvine RJ. Addiction. 1999;94(7):961-972.
2.Pattinson KTS. Br J Anaesth. 2008;100(6):747-758. doi:10.1093/bja/aen094
3.Dahan A, et al. Br J Anaesth. 2005;94(6):825-834. doi:10.1093/bja/aei145
4.Dahan A, et al. Br J Anaesth. 2006;96(5):627-632. doi:10.1093/bja/ael051
5.Gudin J, Fudin J. Pain Ther. 2020;9(1):41-54. doi:10.1007/s40122-019-00143-6
6.Hale M, et al. J Pain Res. 2017;10: 233-240. doi:10.2147/JPR.S120170
7.Rauck RL, et al. Postgrad Med. 2016;128(1):1-11. doi:10.1080/00325481.2016.1128307
8.Gimbel J, et al. Pain. 2016;157(11):2517-2526. doi:10.1097/j.pain.0000000000000670