New Mallinckrodt Data Analysis Shows Limited Use Of Opioid-Free Analgesia, Underutilization In Some Patients More Prone To Opioid-Related Adverse Events

STAINES-UPON-THAMES, United Kingdom, Aug. 9, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced publication of a new retrospective, claims-based data analysis that highlights a disparity between patients currently being treated with opioid-free analgesia (OFA) for surgical procedures and those that the Joint Commission has identified as being more susceptible to opioid-related adverse events (ORADEs).

The Joint Commission is an independent, not-for-profit organization dedicated to helping health care organizations excel in providing safe and effective care of the highest quality and value.  On Aug. 8, 2012, the Joint Commission issued its "Sentinel Event Alert Issue 49: Safe use of opioids in hospitals,"¹ which outlines patient groups that are more susceptible to ORADEs.

Mallinckrodt's new study² investigating utilization patterns and predictors of opioid-free analgesia (OFA) in a surgical population in the United States found that use of post-surgical OFA in U.S. hospitals was limited overall, and, while there could be potential benefit from OFA use versus opioids, OFA was not favored in some patient groups the Joint Commission identified as being more prone to ORADEs. The Mallinckrodt-sponsored analysis was conducted in collaboration with Brigham and Women's Hospital, Harvard Medical School, and recently published in Current Medical Research and Opinion.

"This analysis, which we believe is among the first of its kind in a large patient population, provides important insights that can inform our understanding of OFA approaches to perioperative pain management and potentially benefit patient populations who are at particular risk for opioid-related adverse events," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "A number of healthcare providers today are using opioid-sparing or opioid-free analgesia within enhanced recovery after surgery (ERAS) pathways³ with the goal to reduce opioid use and expansion of this post-surgical pain management approach could make a positive difference in the lives of some patients."

According to the authors of the analysis, evaluation of the OFA population and drivers of OFA use can inform understanding of safe and effective approaches to OFA and highlight the potential to improve and expand this post-surgical pain management approach.²

Analysis of predictors of opioid-free analgesia for management of acute post-surgical pain in the United States² evaluated the Cerner Health Facts database from January 2011 to December 2015 to describe hospital and patient characteristics associated with OFA. Baseline characteristics, such as age, gender, race, discharge status, year of admission and chronic comorbidities at index admission were collected. Hospital characteristics and payer type at index admission were also collected, and descriptive statistics and logistic regression were used to identify statistically significant predictors of OFA, at both the patient and institutional levels.

The analysis identified 10,219 patients, from 187 hospitals, who received post-surgical OFA and 255,196 patients who received post-surgical opioids. Among the qualifying surgeries, only 3.9% of patients received OFA.

Patients more likely to receive OFA were older (odds ratio [OR] =1.06; 95% confidence interval [CI]⁴: 1.03, 1.10; p<.001); or had:

• Neurological disorders (OR=1.24; 95% CI: 1.10, 1.39; p<.001);
• Diabetes (OR=1.20; 95% CI: 1.08, 1.33; p=.001); or
• Psychosis (OR=1.18; 95% CI: 1.01, 1.37; p=.030).

Patients less likely to receive OFA had:

• Obesity (OR=0.80; 95% CI: 0.67, 0.95; p=.010); or
• Depression (OR=0.85; 95% CI: 0.73, 0.98; p=.030).

Rates of OFA varied considerably by hospital. A few hospitals contributed a substantial proportion of OFA patients, suggesting that hospital policies, institutional structure and cross-functional departmental commitment to reducing opioid use may play a large role in the implementation of OFA, as the authors note.

Analysis Limitations

• The analysis did not take into account pre-operative pain and duration of the surgery.
• There was unmeasured institutional confounding and limited access to variables associated with surgical complexity or patient severity.
• Findings from the Health Facts database, may not be generalizable to a broader patient population. The dataset did not include data on patients after Dec. 31, 2015 and more current data will be necessary to gauge trends.
• The nature of this analysis precludes observation and analysis of postsurgical pain scores in response to opioids or OFA, so the efficacy and quality of analgesia provided via OFA versus analgesic regimens containing opioids was not assessed.
• Assumptions cannot be made regarding multimodal analgesia regimens (opioid use in combination with non-opioids) in these patient groups or hospitals.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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Mallinckrodt, the "M" brandmark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 US-1800220 08/18

¹ The Joint Commission. Sentinel Event Alert. 2012;49:1-5. http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed July 13, 2018.

² Richard D. Urman, Elaine A. Böing, Victor Khangulov, Randi Fain, Brian H. Nathanson, George J. Wan, Belinda Lovelace, An T. Pham & Jessica Cirillo (2018) Analysis of predictors of opioid-free analgesia for management of acute post-surgical pain in the United States. Current Medical Research and Opinion, DOI: 10.1080/03007995.2018.1481376

³ Kamdar, Nirav V. MD, MPP; Hoftman, Nir MD; Rahman, Siamak MD; Cannesson, Maxime MD, PhD. Opioid-Free Analgesia in the Era of Enhanced Recovery After Surgery and the Surgical Home: Implications for Postoperative Outcomes and Population Health. Anesthesia & Analgesia. October 2017. 4: 1089-1091. https://journals.lww.com/anesthesia-analgesia/Fulltext/2017/10000/Opioid_Free_Analgesia_in_the_Era_of_Enhanced.3.aspx Accessed July 16, 2018.

⁴ A range of values so defined that there is a specified probability that the value of a parameter lies within it.

SOURCE Mallinckrodt plc

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