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days to go: ASP+6% CMS reimbursement for proven non-opioids used in all outpatient surgical settings is coming January 1, 2025.

The majority of surgical patients receive opioids and many will go on to become persistent long-term users1,2

While opioids have been a mainstay in postsurgical pain control, they are also at the center of an ongoing national crisis. For many patients undergoing surgery, it is their first exposure to opioids.

99% of patients receive opioids to manage
post-surgical pain2*

1 out of 15 surgical patients prescribed an opioid may go
on to long-term use or abuse3,4†

An estimated 1.1 million Americans will become persistent users of opioids each year following initial exposure after surgery in the hospital3

*In a retrospective study of hospital discharge data (N=37,301).

†In a prospective longitudinal study (N=109).

Newly persistent opioid patients by percentage

7.2%

Hernia

7.5%

Hysterectomy

8.5%

Sleeve Gastrectomy

9.9%

Total Hip

10.2%

Rotator Cuff

16.7%

Total Knee

17.6%

Colectomy

Overall nearly 9.5% of surgical patients who had not been taking opioids prior to the perioperative period became newly persistent users in 20175*

*Newly persistent is defined as a patient using an opioid 3 to 6 months beyond the postsurgical recovery period.

There are risks associated with opioid exposure

68% of people using pain relievers (non-medically) obtained them from a friend or relative6*

4 out of 5 new heroin users started out by misusing opioids7†

*According to the 2013 National Survey on Drug Use and Health among past-year users aged ≥ 12 years (N≈37,000).

†From an analysis of the 2008-2010 National Surveys on Drug Use and Health to examine patterns of heroin use and risk behaviors among past-year non-medical users of opioid pain relievers.

Most patients would prefer a non-opioid option to control their pain after surgery8*

~90% of patients said they were concerned about side effects of, addiction to, or dependence on opioids

79% of patients said they preferred a non-opioid pain management option

*From a survey of 500 adults in the United States who had an orthopedic or soft tissue surgery and 200 US surgeons who perform these procedures.

ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.

Important Notice

Indication

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
  • Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
  • Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
  • Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
  • EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
  • Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions Specific to EXPAREL

  • Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
  • The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Warnings and Precautions for Bupivacaine-Containing Products

  • Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
  • Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
  • Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
  • Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
  • Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Please refer to full Prescribing Information.

References

  1. Brummett CM, Waljee JF, Goesling J, et al. New persistent opioid use after minor and major surgical procedures in US adults. JAMA Surg. 2017;152(6):e170504. doi:10.1001/jamasurg.2017.0504.
  2. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383-391.
  3. Carroll I, Barelka P, Wang CKM, et al. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012;115(3):694-702.
  4. Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CH. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012;172(5):425-430.
  5. Pacira Pharmaceuticals, Inc. United States for Non-Dependence: An Analysis of the Impact of Opioid Overprescribing in America. September 2017. [Analysis in the report was based on research conducted by the QuintilesIMS Institute.]
  6. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, Substance Abuse and Mental Health Services Administration, 2014. NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD.
  7. Jones CM. Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers—United States, 2002–2004 and 2008–2010. Drug Alcohol Depend. 2013;132(1-2):95-100.
  8. New research: opioid addiction and dependence after surgery is significantly higher than previously known [news release]. Parsippany, NJ: Pacira Pharmaceuticals, Inc; August 1, 2016. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irolnewsArticle_pf&ID=2191316 Accessed August 19, 2020.
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EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

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