LUNCH AND LEARN. Sterile Drug Products Used in the Anesthesia Practice Setting: Part 2. February 10, 2017

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1 LUNCH AND LEARN Sterile Drug Products Used in the Anesthesia Practice Setting: Part 2 February 10, 2017 Featured Speaker: Julie A. Golembiewski, PharmD Clinical Associate Professor, Department of Pharmacy Practice Clinical Associate Professor of Anesthesiology University of Illinois at Chicago Colleges of Pharmacy and Medicine CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Golembiewski has no relevant commercial and/or financial relationships to disclose

2 Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to Print your CE Statement online Live CE Deadline: March 10, 2017 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 2

3 Resources Visit to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Sterile Drug Products Used in the Anesthesia Setting Part 2 Julie Golembiewski PharmD February 10,

4 THE OPERATING ROOM Anesthesia Care Provider Surgeon 7 CARDIOVASCULAR DRUGS ADRENERGIC RECEPTORS Receptor Location Response (Agonist activity) Alpha 1 Vascular smooth muscle, heart Contraction Alpha 2 Vascular smooth muscle Contraction Beta 1 Heart Increased force and rate of contraction Beta 2 Smooth muscle (lungs, vascular) Relaxation 8 4

5 CLASSIFICATION OF BETA-BLOCKERS Classification Non-selective (blocks beta 1 and beta 2 decreases HR) Beta 1 selective (decreases force and rate of contraction decreases HR) Alpha-blocking activity >> beta-blocking activity (relaxes vascular smooth muscle decreases BP) Agent Propranolol Esmolol, metoprolol Labetolol 9 Beta Blockers Property Esmolol Metoprolol Pharmacology Beta 1 antagonist Reduces HR and, to a much lesser extent, BP Beta 1 antagonist Reduces HR and, to a much lesser extent, BP Peak effect 5 minutes 10 minutes (IV) Duration (IV) minutes 6 hours Usual dose mg, up to 0.5 mg/kg 2 mg

6 Property Hydralazine Labetolol Pharmacology Direct relaxation of vascular smooth muscle Alpha 1 blocker, nonselective beta antagonist Reduces BP Reduces BP, less effect on HR than propranolol Peak effect (IV) 5 20 minutes 5 15 minutes Duration (IV) 1 4 hours 2 18 hours Clinical Considerations Antihypertensives Reflex tachycardia Less reflex tachycardia due to beta blocker effects Usual dose 5 mg 5 10 mg 11 VASOPRESSORS Property Phenylephrine Norepinephrine Pharmacology Alpha 1 agonist Alpha 1 agonist (vasoconstriction) (vasoconstriction) Beta 1 and some Beta 2 effects Relaxing effect on venous resistance enhanced venous return to heart increased CO with little effect on HR BP Increased Increased HR Decreased No change or increased Contractility No change or Increased decreased Venous return Increased Decreased Cardiac output Decreased Increased Typical IV bolus dose mcg 2 8 mcg Norepinephrine increases BP by arterial vasoconstriction and an increase or maintenance of HR, stroke volume and cardiac output

7 EPHEDRINE VS. EPINEPHRINE Property Ephedrine Epinephrine Pharmacology Indirect stimulation of alpha 1 and beta 1 receptors Beta 1, beta 2 and in higher doses, alpha 1 Increases BP, HR, contractibility and cardiac output Increases HR, cardiac output, BP (less than others) bronchodilator 13 OPIOIDS

8 OPIOIDS Indications Blunt hemodynamic response to: Laryngoscopy Surgical stimulation Provide analgesia Reduce anesthetic requirement Agents Fentanyl, sufentanil, remifentanil, morphine, hydromorphone Considerations Onset Duration Route of elimination Opioids alone do NOT provide anesthesia 15 Property Morphine Hydromorphone Fentanyl (Dilaudid) Onset 5 min 5 min 2 min Peak min min 5 7 min Duration 3 4 hours 2 3 hours min Renal dysfunction Equianalgesic dose Active metabolite can accumulate OK OK 1 mg 0.2 mg 12.5 mcg (plasma) (brain) Anesthesiology. 2010;112:

9 Sufentanil 5 10 times more potent than fentanyl Usual dose: 5 20 mcg IV bolus Similar onset and peak, but more rapidly eliminated than fentanyl when multiple doses (or infusion) administered Remifentanil Slightly more potent than fentanyl Usual dose: mcg IV bolus Rapidly eliminated by nonspecific plasma and tissue esterases Shortest duration of action ( 10 minutes) Infusion (usual range: mcg/kg/min 0.2 mcg/kg/min) 17 Context-Sensitive Halftime Anesthesiology. 1993;79:

10 OPIOID ADVERSE EFFECTS Nausea, vomiting, constipation Sedation, dizziness Itching Bradycardia (intra-op boluses) Apnea, respiratory depression 19 LOCAL ANESTHETICS

11 Local Anesthetics Agent Onset Duration Max Dose * Comments Chloroprocaine Fastest Short 800 (1,000) Epidural Lidocaine Rapid Intermediate 300 (500) Most frequently used Mepivacaine Moderate Intermediate 300 (500) Nerve block, epidural Bupivacaine Slow Long ** (up to 12 hrs) Bupivacaine liposome Slow Longest (up to 72 hrs) Ropivacaine Slow Long ** (up to 12 hrs) 175 (225) Local infiltration, nerve block, epidural, spinal 266 Local infiltration only 200 (200) Local infiltration, nerve block, epidural * In milligrams; epinephrine containing solution in parenthesis ** May be given as a continuous infusion for local infiltration, epidural, peripheral nerve block 21 SPINAL AND EPIDURAL ANESTHESIA Spinal needle

12 NERVE BLOCK ANESTHESIA Femoral nerve block Sciatic nerve block Source: LOCAL INFILTRATION (SURGEON) Source:

13 Local Anesthetic Infusions 25 PERIOPERATIVE ROUTES OF ADMINISTRATION OF LOCAL ANESTHETICS Surgeon Topical* Subcutaneous, deep tissue Transversus abdominal plane* Tumescent technique Anesthesia Spinal Epidural Intravenous (lidocaine only) Peripheral nerve block Intra- or periarticular * Surgeon or Anesthesia

14 PERIOPERATIVE ROUTES OF ADMINISTRATION Fast OF LOCAL onset, ANESTHETICS Short duration (1-3 hrs) Topical Subcutaneous, deep tissue Transversus abdominal plane Lidocaine Spinal Epidural Intravenous Tumescent technique Intra- or periarticular Peripheral nerve block 27 Bupivacaine PERIOPERATIVE or Ropivacaine ROUTES OF ADMINISTRATION OF LOCAL ANESTHETICS Slow onset, long duration (4 18 hrs) Topical Subcutaneous, deep tissue Transversus abdominal plane Tumescent technique Intra- or periarticular Spinal (bupivacaine only) Epidural Intravenous Peripheral nerve block

15 PERIOPERATIVE ROUTES OF Liposome Bupivacaine ADMINISTRATION OF LOCAL ANESTHETICS Fast onset, long duration (up to 72 hrs) Topical Subcutaneous, deep tissue Transversus abdominal plane Spinal (bupivacaine only) Epidural Intravenous Tumescent technique Intra- or periarticular Peripheral nerve block 29 EPIDURAL ANALGESIA Indication Postoperative pain, labor pain, pain unrelieved by systemic analgesics Agents Local anesthetic + opioid Bupivacaine 0.1% + fentanyl 2 mcg/ml Bupivacaine 0.1% + hydromorphone 10 mcg/ml Others (ropivacaine, sufentanil) Local anesthetic alone Opioid alone Administered as a: Single bolus dose Continuous infusion +/- patient-controlled bolus doses

16 LOCAL ANESTHETIC TOXICITY CLASSIC TEACHING 31 HOWEVER Nearly half of reports of local anesthetic systemic toxicity are in patients either < 16 years old (16%) or > 60 years old (30%) More than one third of reports of toxicity involved patients with underlying cardiac, neurologic, renal, hepatic, pulmonary or metabolic disease Dose reduction and heightened vigilance may be warranted in such patients, particularly if they re at the extremities of age Neal et. al. Reg Anesth Pain Med. 2010;35:152. Rosenberg et. al. Reg Anesth Pain Med. 2004;29:

17 ASRA Checklist for Treatment of Local Anesthetic Systemic Toxicity METHEMOGLOBINEMIA LAs are indirect oxidizers of iron within hemoglobin methemoglobin unable to transport oxygen As methemoglobin levels rise, may see: Cyanosis, altered mental status, seizures Tachypnea, tachycardia, respiratory compromise Skin and mucous membranes appear bluish, gray or pale; blood may be chocolate-colored Because pulse ox cannot detect > 2 wavelengths of light, high concentrations of methemoglobin cause incorrect readings in O 2 saturation reported by pulse ox Although four local anesthetics have been implicated (prilocaine, benzocaine, lidocaine, tetracaine), benzocaine and prilocaine most common Guay J. Anesth Analg 2009;108:

18 Medication Safety 35 Wahr et. al. Literature review to identify those medication safety recommendations that at least are based on the opinions of respected authorities 197 articles reviewed 78 articles met inclusion criteria Data extracted, recommendations graded Results 128 specific, unique recommendations made Br J Anaesth. 2017;118(1):

19 MEDICATION SAFETY - STRATEGY CATEGORIES Patient information Drug information Anesthesia cart medication inventory Medication administration Culture Pharmacy Br J Anaesth. 2017;118(1): SELECT STRATEGIES Anesthesia medication trays Standardized across all locations Tray divisions labeled clearly Drugs placed to minimize confusion Modular system Pharmacy manages drug trays Single use vials preferable; if multidose is required, discard at end of case Only one standard concentration on cart Pharmacy Provides diluted, high-risk drugs Prepares compounded drugs Prepares infusions Alerts anesthesia/or staff when there are changes in drugs supplied (new labels, new concentrations, etc.) Regional anesthetic solutions (spinal, epidural and nerve block medications) clearly segregated from IV medications

20 MEDICATION TRAY REDESIGN EXAMPLE 1 Gemensky J. US Pharm. 2015;40(3):HS8-HS MEDICATION TRAY REDESIGN EXAMPLE 2 Problems Solutions Problems Identified: A slots covered entire medication vial; cannot read label B slots are rigid and cannot accommodate vial size changes C trays are similar in size; possible erroneous placement of same tray side by side D nonintuitive placement of medications (have to search for desired med) E syringe location inconsistent; boxes moved The Joint Commission Journal of Quality and Patient Safety. 2016;42(10)

21 41 ASA Statement on Creating Levels of Pharmaceuticals for use in Anesthesiology Last amended October 28,

22 Label Enhancements to Reduce Drug Administration Errors: Bar coding: Essential information, including the drug s generic name and concentration could be bar coded at a location on the label which will not interfere with the label s legibility, as specified in Section 8 of ASTM D6398. Label material shall allow the user to write information on it using a ball-point pen or felt-tip marker without smudging or blurring as specified in Section 2.3 of ISO 26825:2008. Printing: All printing is in black bold type with the exception of succinylcholine and epinephrine which are printed against the background color as reverse plate letters within a black bar running from edge to edge of the label. Tall Man Letters: The FDA Office of Generic Drugs requested manufacturers of sixteen lookalike name pairs to voluntarily revise the appearance of their established names in order to minimize medication errors resulting from look-alike confusion. Letters from the FDA encouraged manufacturers to revise labels and labeling that visually differentiated their established names with the use of "Tall Man" letters. The following are Tall Man drug names from lists of easily confused medications compiled by the FDA and the ISMP that may be administered by the anesthesia care team during a procedure. ASA Statement on Creating Levels of Pharmaceuticals for use in Anesthesiology Last amended October 28, SUMMARY In addition to drugs discussed in part 1 of this CE program, drugs used by anesthesia include: Vasoactive drugs Increase and decrease blood pressure and heart rate Generally bolus doses rather than infusions Opioids Analgesic, blunt response to laryngoscopy and surgical stimulation and reduce anesthetic requirements Short vs. longer-acting agents intra- vs. post-op Local anesthetics Administered by anesthesia and surgeon Many routes of administration Toxicity Medication safety strategies Anesthesia medication tray contents and design Single vs. multiple dose vials, concentration, labeling Role of pharmacy

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