Opioid Burden

Current treatment strategy leaves room for improvement

Although as many as 99% of postsurgical patients receive an opioid1

Postsurgical patient survey of patients who had undergone surgery in the past 5 years Postsurgical patient survey of patients who had undergone surgery in the past 5 years Postsurgical patient survey of patients who had undergone surgery in the past 5 years

Postsurgical patient survey of patients who had undergone surgery in past 5 years (N=300).2

Opioids: effective, yet pose concerns for patients and healthcare providers1-4

  • Adverse events increase risk of morbidity, delay ambulation, can increase length of stay, and lead to hospital readmissions1,3
    • Opioids are not recommended in several high-risk patient populations3
    • Opioid-related issues can have a negative impact on patient satisfaction and reimbursement2,4,5

A high potential for misuse, dependency, or diversion creates a societal burden6-8

  • 1 in 15 patients prescribed opioids will go on to long-term use or abuse6,7
  • In a study (N=250), the average patient consumed 1/3 of their opioid prescription, resulting in a total of 4,639 leftover pills that could be diverted8
  • In 2010, approximately 5 million people were classified as opioid abusers9

Read the FDA News Release about new prescription opioid medication safety warnings.

Test your knowledge about opioids and the opioid crisis in America

For many Americans every year, often, their first exposure to opioids may occur in a short-term care setting, such as a hospital or outpatient clinic. Most individuals accept — and even expect — that they or their loved ones will be sent home with opioids after surgery. However, for many, this has led to a dangerous pathway of dependence.

The reach and the consequences of the opioid crisis continue to shock: Since 1999, overdose deaths involving prescription opioids have quadrupled.10

QUESTION 1 POSTSURGICAL ABUSE: Pill Count

Out of an opioid prescription for 30 pills after surgery, on average, how many were consumed?

The correct answer is 10

So what happens to those leftover pills? The Centers for Disease Control and Prevention (CDC) warns that many people who misuse prescription painkillers use medication that had been prescribed for someone else.

References
  • Office of National Drug Control Policy. 2013 Drug overdose mortality data announced: prescription opioid deaths level; heroin-related deaths rise [press release]. January 12, 2015. http://www.whitehouse.gov/ondcp/news-releases/2013-mortality-data. Accessed May 26, 2016.
  • Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012;37(4):645-650.
  • Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014. NSDUH Series H-48, HHS Publication No. (SMA) 14-4863.

QUESTION 2 POSTSURGICAL ABUSE: Addiction

At 1 year post-surgery, approximately how many patients who underwent elective cervical spine repair surgery were still using opioids?

The correct answer is one-third

Approximately one-third of all patients were still using opioids 1 year after surgery.

Reference
  • Wang M, Lozen AM, Krebs EE, Laud PW, Nattinger AB. Predictors of 12-month opioid use after elective cervical spine surgery for degenerative changes [abstract]. Spine. 2013;13(suppl):S6-S7.

QUESTION 3 POSTSURGICAL ABUSE: Chronic Users

True or False: Approximately 1 in 15 patients will become chronic opioid users after surgery.

The correct answer is True

1 in 15 patients will become chronic opioid users after surgery.

References

QUESTION 4 GROWING EPIDEMIC: Daily Growth


True or False: 5.1 million people are classified as prescription opioid abusers. 


The correct answer is True

In 2010, 5.1 million people were classified as prescription opioid abusers. Alarmingly, 2 million were first-time abusers, which equates to approximately 5,500 new abusers every day.


References

QUESTION 5 GROWING EPIDEMIC: Gateway

What percentage of people who abuse or who are dependent on pain medication go on to use heroin?

The correct answer is 14%

Abusing prescription opioid painkillers, like OxyContin® and Vicodin®, often leads to heroin use. Reports show that heroin is cheaper, easier to obtain, and produces a similar high to opioids.

Reference

QUESTION 6 GROWING EPIDEMIC: Sports


What is the risk for adolescent male organized sports athletes to misuse opioid medications to get high as compared with those not involved in sports?


The correct answer is 4x


The odds of male athletes in organized sports using opioids to get high are 4x greater than for those not participating. Furthermore, there is a 2x greater risk for these athletes to be prescribed opioids and a 10x greater risk of their general medical misuse.

Reference
  • Veliz P, Epstein-Ngo QM, Meier E, Ross-Durow PL, McCabe SE, Boyd CJ. Painfully obvious: a longitudinal examination of medical use and misuse of opioid medication among adolescent sports participants. J Adolesc Health. 2014;54(3):333-340.

QUESTION 7 FACTS IN NUMBERS: The Script

How many prescriptions for opioids were written in the United States in 2012?

The correct answer is 259 million

In 2012, there were enough opioids prescribed in the United States so that every American could have a full bottle of pills — equal to medicating every adult with 5 mg of hydrocodone every 6 hours for 45 days.

Reference

QUESTION 8 FACTS IN NUMBERS: Overdose Deaths


True or False: Among people aged 25 to 64 years, car accidents caused more deaths than drug overdoses in 2013.


The correct answer is False

Among people aged 25 to 64 years, drug overdose caused more deaths in 2013 than car accidents. In fact, 78 people die every day in the United States from an overdose of prescription opioids.

Reference

QUESTION 9 FACTS IN NUMBERS: Drug War

Which of the following has had a higher death toll?

The correct answer is opioid overdose death

The total number of opioid-related deaths in the United States (>100,000) between 1999 and 2010 far exceeds the number of US military casualties in the Vietnam War (58,000) between 1965 and 1975.

Reference
  • Franklin GM. American Academy of Neurology. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology. 2014;83(14):1277-1284.

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EXPAREL in Oral Surgery

Find information on using EXPAREL for local infiltration in oral surgery.

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Important Notice

This site is for informational purposes only and is intended to address medical questions from healthcare professionals in the United States.

To report an adverse event, e-mail drugsafety@pacira.com or dial 1-855-RX-EXPAREL (1-855-793-9727).

For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-RX-EXPAREL (1-855-793-9727).

These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.

References

  1. 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.
  2. Gan TJ, Habib AS, Miller TE, White W. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014;30(1):149-160.
  3. The Joint Commission. Safe use of opioids in hospitals. The Joint Commission Sentinel Event Alert; August 8, 2012; Issue 49.
  4. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.
  5. Survey of patients’ experiences. Medicare.gov. http://www.medicare.gov/hospitalcompare/about/survey-patients-experience.html. Accessed May 26, 2016.
  6. Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012;172(5):425-430.
  7. 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.
  8. Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012;37(4):645-650.
  9. Popping pills: prescription drug abuse in America. National Institute on Drug Abuse. http://www.drugabuse.gov/related-topics/trends-statistics/infographics/popping-pills-prescription-drug-abuse-in-america. Accessed May 26, 2016.
  10. Centers for Disease Control and Prevention. Prescription opioid overdose data. http://www.cdc.gov/drugoverdose/data/overdose.html. Updated March 12, 2016. Accessed May 26, 2016.

Important Safety Information

Warnings and Precautions Specific to EXPAREL

Warnings and Precautions for Bupivacaine-Containing Products

Please refer to full Prescribing Information.

Important Safety Information

Medical Information

US healthcare professionals Click Here

Non-US healthcare professionals can submit a request to medinfo@pacira.com

If you are not a healthcare professional, please discuss any questions you have regarding your health or treatment with your physician, pharmacist, nurse, or other healthcare professional.

Important information about EXPAREL®

The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.

"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate."

- Dave Stack, Chief Executive Officer and Chairman of Pacira

The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia
  • In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
  • EXPAREL is not recommended to be used in the following patient population: patients <18 years old 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. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations

Warnings and Precautions Specific to EXPAREL

  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use
  • 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. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL

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 paresthesias. 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

Please refer to full Prescribing Information.

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