• In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.


Local Analgesia via Infiltration Dosing in Pediatric Patients


The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery.


Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults


The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair.


Compatibility Considerations


Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended.


• 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.


• Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.


The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.


• When a topical antiseptic such as povidone iodine (e.g., Betadine® )


is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.


Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL.


Non-Interchangeability with Other Formulations of Bupivacaine


Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.


Liposomal encapsulation or incorporation in a lipid complex can


substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.


CLINICAL PHARMACOLOGY


Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy.


PATIENT COUNSELING


Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.


STANFORD R. PLAVIN, MD


Title: ASCA Board Member and Anesthesiologist Facility Name: Ambulatory Anesthesia Partners City: Atlanta State: Georgia


Q What are some best practices for working with anesthesia providers in the ASC setting?


A It is an extremely important question to answer and one that can be viewed through several different prisms and vantage points. The ASC


setting, as we can appreciate, is a site of service that provides access and excellence to our patients. Anesthesia providers are a key component of the success of the facility but can also be an area of concern if the incorrect provider is in place. One of the key decisions that an ASC will undertake is selection of their


anesthesia provider. Often, these providers are already in place when a new administrator or management team arrives on the scene. That said, a fresh look should be undertaken to review the current relationship, and if the ASC is lucky enough to start de novo, a fresh start is even better. As an anesthesiologist who has worked in the ASC setting since 1997, I can appreciate how the role has changed and, along with that, the expectations. Below are what I view as a few of the “best practices.” It is up to the facility, management, staff and surgeons at an ASC to further define what they view as the “best practices” as they relate to their needs and goals. The following list will provide a solid foundation with which to assess


Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA


Patent Numbers: 6,132,766


5,891,467 5,766,627 8,182,835


Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only


March 2021


your current or future anesthesia provider: 1) Clinical excellence; professional advancement and training 2) Focus and communication skills 3) Professionalism and engagement with all parties 4) Commitment to the practice site/facility and its goals and mission 5) Interpersonal skills and collaborative approach 6) Advocacy 7) Business development and recruitment (if applicable)


8) Safe medical practices—patient safety initiatives/infection control/ workspace


9) Patient outcomes—including benchmarking and assessment (survey)


10) Associated provider costs—can vary based upon current business model and also the specific provider needs and wants to provide deliverables


11) Patient, physician, staff satisfaction—esprit de corps. Prioritizing this list should be done by those who will be making the


decisions around the selection/assessment of the anesthesia services at the site. It is my opinion that clinical excellence and professionalism remain at the top of anyone’s list.


ASC FOCUS MAY 2021 | ascfocus.org 27


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