New Mallinckrodt Data Analysis Shows Limited Use Of Opioid-Free Analgesia, Underutilization In Some Patients More Prone To Opioid-Related Adverse Events
Published: Aug 09, 2018
STAINES-UPON-THAMES, United Kingdom, Aug. 9, 2018 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (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:
Patients less likely to receive OFA had:
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.
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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.
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