Pacira Pharmaceuticals, Inc
. (NASDAQ: PCRX) today announced that the full findings from the regional health system analysis conducted by Barnabas Health to quantify the relationship between opioid use, total hospital charges and patient length of stay (LOS) were published in
. This study demonstrated that in addition to increased hospital charges, patients undergoing total abdominal hysterectomy (TAH) with an unusually long LOS (five days or more) also had a higher incidence of opioid-related adverse events (ORAEs) compared to the control group of patients with a more typical LOS (less than five days).
from this retrospective analysis were discussed in a poster presentation given at the American Society of Health-System Pharmacists meeting in December 2011.
“In numerous published studies, including this analysis, higher opioid use has been associated with opioid-related adverse events, prolonged hospitalization and increased costs of care,” said Dave Stack, President and CEO of Pacira. “Reliance on an opioid-based pain management regimen can not only have a negative impact on a patient’s recovery course, but can also increase the overall cost burden on the healthcare system.”
In the study, medical records of patients undergoing TAH were reviewed to identify LOS ‘outliers,’ or patients with an LOS lasting greater than or equal to five days. Researchers matched 97 LOS outliers with an equal number of control patients who had an LOS that was less than five days, and similar baseline characteristics. Comparisons between the two groups showed that LOS outliers:
- Remained hospitalized 5.5 days longer than controls
- Had $8,544 more in total hospital charges than control patients ($14,289 vs. $5,745, respectively)
- Received more than two times the total opioid dose compared to the controls by the time of discharge
- Reported a markedly higher incidence of ORAEs compared to controls
- Gastrointestinal ORAEs occurred in 44 percent of outliers compared to 19 percent of control patients; P< 0.01
- Respiratory ORAEs occurred in 12 percent of outliers compared to just one percent of control patients; P< 0.01
Although potent analgesics, opioids are associated with a wide range of unwanted and potentially life-threatening adverse events, including nausea, vomiting, constipation, urinary retention and respiratory depression. A recent
Sentinel Event Alert
issued by the Joint Commission details the risk for opioid-induced oversedation and respiratory depression in certain patient populations and recommends a multimodal approach to postsurgical pain management.
The Joint Commission advises that upon individual patient assessment, the best approach may be to start with a non-opioid medication.
The regional health system analysis conducted by Barnabas Health was supported by Pacira Pharmaceuticals; the full publication is available online
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL
(bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam
, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at
(bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam
, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.