Sterile Drug Products Used in the Anesthesia Practice ...s3.proce.com/res/pdf/PharMEDium2017Feb.pdfbenzocaine and prilocaine most common Guay J. AnesthAnalg 2009;108:837 34 Sterile

Sterile Drug Products Used in the Anesthesia Practice Setting: Part 2PharMEDium Lunch and Learn Series

ProCE, Inc.www.ProCE.com 1

Sterile Drug Products Used in theAnesthesia Practice Setting: Part 2

February 10, 2017

Featured Speaker: Julie A. Golembiewski, PharmD

Clinical Associate Professor, Department of Pharmacy Practice

Clinical Associate Professor of AnesthesiologyUniversity of Illinois at ChicagoColleges of Pharmacy and Medicine

LUNCH AND LEARN

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Tech CE)

1.0 contact hour

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Funding: This activity is self‐funded through PharMEDium.

It is the policy of ProCE, Inc. 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.



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Sterile Drug Products Used in the Anesthesia Setting – Part 2

Julie Golembiewski PharmDFebruary 10, 2017

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THE OPERATING ROOM

Anesthesia Care Provider

Surgeon 7

CARDIOVASCULAR DRUGSADRENERGIC 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

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CLASSIFICATION OF BETA-BLOCKERS

Classification Agent

Non-selective (blocks beta 1 and beta 2 decreases HR)

Propranolol

Beta 1 selective(decreases force and rate of contraction decreases HR)

Esmolol, metoprolol

Alpha-blocking activity >> beta-blocking activity(relaxes vascular smooth muscle decreases BP)

Labetolol

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Property Esmolol Metoprolol

Pharma-cology

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 (IV)

5 minutes 10 minutes

Duration (IV) 10 – 30 minutes 6 hours

Usual dose 10 - 20 mg, up to 0.5 mg/kg

2 mg

Beta Blockers

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Property Hydralazine Labetolol

Pharmacology Direct relaxation of vascular smooth muscle

Reduces BP

Alpha 1 blocker, nonselective beta

antagonist

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

ClinicalConsiderations

Reflex tachycardia Less reflex tachycardia due to beta blocker effects

Usual dose 5 mg 5 – 10 mg

Antihypertensives

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VASOPRESSORS Property Phenylephrine Norepinephrine

Pharmacology Alpha 1 agonist(vasoconstriction)

Alpha 1 agonist(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 decreased

Increased

Venous return Increased Decreased

Cardiac output Decreased Increased

Typical IV bolus dose

40 – 100 mcg 2 – 8 mcg

Norepinephrine increases BP by arterial vasoconstriction and an increase or maintenance of HR, stroke volume and cardiac output

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Property Ephedrine Epinephrine

Pharmacology Indirect stimulationof alpha 1 and beta 1 receptors

Increases BP, HR, contractibility and cardiac output

Beta 1, beta 2 and in higher doses,

alpha 1

Increases HR, cardiac output, BP (less than others)

bronchodilator

EPHEDRINE VS. EPINEPHRINE

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OPIOIDS

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OPIOIDS

AgentsFentanyl, sufentanil, remifentanil, morphine, hydromorphone

ConsiderationsOnset

Duration

Route of elimination

Indications• Blunt hemodynamic

response to:• Laryngoscopy

• Surgical stimulation

• Provide analgesia

• Reduce anesthetic requirement

Opioids alone do NOT provide anesthesia15

(plasma) (brain)

Anesthesiology. 2010;112:226.

Property Morphine Hydromorphone

(Dilaudid)

Fentanyl

Onset 5 min ≤ 5 min ≤ 2 min

Peak 15 - 20 min 10 – 20 min 5 – 7 min

Duration 3 – 4 hours 2 – 3 hours 30 – 60 min

Renal dysfunction Active metabolite can accumulate

OK OK

Equianalgesicdose

1 mg 0.2 mg 12.5 mcg

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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: 12.5 – 25 mcg IV bolus– Rapidly eliminated by nonspecific plasma and

tissue esterases– Shortest duration of action ( 10 minutes)

• Infusion (usual range: 0.025 mcg/kg/min – 0.2 mcg/kg/min)

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Anesthesiology. 1993;79:881–892 .

Context-Sensitive Halftime

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OPIOID ADVERSE EFFECTS

• Nausea, vomiting, constipation

• Sedation, dizziness

• Itching

• Bradycardia (intra-op boluses)

• Apnea, respiratory depression

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LOCAL ANESTHETICS

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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)

175 (225) Local infiltration,nerve block, epidural, spinal

Bupivacaine liposome

Slow Longest (up to 72hrs)

266 Local infiltration only

Ropivacaine Slow Long **(up to 12 hrs)

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

Local Anesthetics

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SPINAL AND EPIDURAL ANESTHESIA

Spinal needle

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NERVE BLOCK ANESTHESIA

Femoral nerve block Sciatic nerve block

Source: http://www.privatehealth.co.uk/private-operations/Anaesthesia/femoral-nerve-block/http://www.privatehealth.co.uk/private-operations/Anaesthesia/sciatic-nerve-block/

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Source:

LOCAL INFILTRATION(SURGEON)

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Local Anesthetic Infusions

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PERIOPERATIVE ROUTES OF ADMINISTRATION OF LOCAL ANESTHETICS

Topical*

Subcutaneous,deep tissue

Transversusabdominal plane*

Tumescenttechnique

Intra- orperiarticular

Spinal

Epidural

Intravenous(lidocaine only)

Peripheralnerve block

Surgeon Anesthesia

* Surgeon or Anesthesia 26




Topical


Transversusabdominal plane

Tumescenttechnique


Spinal

Epidural

Intravenous


LidocaineFast onset,

Short duration (1 - 3 hrs)

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Topical



Tumescenttechnique


Spinal (bupivacaine only)

Epidural

Intravenous



Bupivacaine or RopivacaineSlow onset, long duration (4 – 18 hrs)

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Topical



Tumescenttechnique


Spinal (bupivacaine only)

Epidural

Intravenous


Liposome BupivacaineFast onset, long duration (up to 72 hrs)

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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

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LOCAL ANESTHETIC TOXICITY –CLASSIC TEACHING

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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;29:564. 32



ASRA Checklist for Treatment of Local Anesthetic Systemic

Toxicity 2012

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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 O2 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;108:83734



Medication Safety

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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):32-43.36



MEDICATION SAFETY -STRATEGY CATEGORIES

• Patient information

• Drug information

• Anesthesia cart medication inventory

• Medication administration

• Culture

• Pharmacy

Br J Anaesth. 2017;118(1):32-43.37

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

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MEDICATION TRAY REDESIGN EXAMPLE 1

Gemensky J. US Pharm. 2015;40(3):HS8-HS12. 39

MEDICATION TRAY REDESIGNEXAMPLE 2

Problems Identified:A – slots covered entire medication vial; cannot read labelB – slots are rigid and cannot accommodate vial size changesC – trays are similar in size; possible erroneous placement of same tray side by sideD – nonintuitive placement of medications (have to search for desired med)E – syringe location inconsistent; boxes moved

SolutionsProblems

The Joint Commission Journal of Quality and Patient Safety. 2016;42(10)473-477. 40



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ASA Statement on Creating Levels of Pharmaceuticals for use in AnesthesiologyLast amended October 28, 2015 42



Label Enhancements to Reduce Drug Administration Errors:

Bar coding: Essential information, including the drug’s generic name and concentration couldbe bar coded at a location on the label which will not interfere with the label’s legibility, asspecified in Section 8 of ASTM D6398.

Label material shall allow the user to write information on it using a ball-point pen or felt-tipmarker 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 andepinephrine which are printed against the background color as reverse plate letters within ablack bar running from edge to edge of the label.

Tall Man Letters: The FDA Office of Generic Drugs requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order tominimize medication errors resulting from look-alike confusion. Letters from the FDAencouraged manufacturers to revise labels and labeling that visually differentiated theirestablished names with the use of "Tall Man" letters. The following are Tall Man drug namesfrom lists of easily confused medications compiled by the FDA and the ISMP that may beadministered by the anesthesia care team during a procedure.

ASA Statement on Creating Levels of Pharmaceuticals for use in AnesthesiologyLast amended October 28, 2015

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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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Documents

Sterile Drug Products Used in the Anesthesia Practice ...s3.proce.com/res/pdf/PharMEDium2017Feb.pdfbenzocaine and prilocaine most common Guay J. AnesthAnalg 2009;108:837 34 Sterile