ask the experts: emerging agents and practice trends for...

Ask the Experts: Emerging Agents and Practice Trends for the Monitoring and Reversal of

Anesthesia in Postsurgical Patients

Presented as a Live Webinar

Tuesday, February 23, 2016 12:00 p.m. – 1:00 p.m. ET

On-demand Activity Live webinar recorded and archived to be watched at your convenience

Available May 16, 2016

www.cemidday.com/15-anesthesia/experts

This activity is sponsored by the American Society of Health-System Pharmacists (ASHP) and planned by ASHP Advantage, a division of ASHP. Supported by an educational grant from Merck

© 2016 American Society of Health-System Pharmacists, Inc.

http://www.cemidday.com/15-anesthesia/experts

Ask the Experts: Emerging Agents and Practice Trends for the Monitoring and Reversal of Anesthesia in Postsurgical Patients

Activity Overview

This activity will focus on current issues related to the monitoring and reversal of specific anesthesia medications or their side effects in the postsurgical setting. The faculty will address the key issues and provide practice pearls for physicians and pharmacists. The content for this activity is based on questions and comments from participants at a recent educational symposium on this topic. Time for additional questions from the webinar audience will be provided at the end of the presentation.

Learning Objectives

At the conclusion of this application-based educational activity, participants should be able to • Discuss new developments and best practices in the monitoring and reversal of anesthesia

medications or their side effects in the postsurgical setting. • Using patient case-based scenarios develop a plan to manage post-operative nausea and

vomiting (PONV). • Outline components of an effective working relationship between anesthesiology and pharmacy

in the operating room.

Continuing Education Accreditation

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1.0 hour (0.1 CEU – no partial credit) of continuing pharmacy education

credit.

Live Activity ACPE #: 0204-0000-16-420-L01-P

On-Demand Activity ACPE #: 0204-0000-16-420-H01-P

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The American Society of Health-System Pharmacists designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Participants will process CE credit online at http://elearning.ashp.org/my-activities. CPE credit will be reported directly to CPE Monitor. Per ACPE, CE credit must be claimed no later than 60 days from the date of the live activity or completion of a home study activity.

© 2016 American Society of Health-System Pharmacists, Inc. 2

http://elearning.ashp.org/my-activities


Webinar Information

Visit www.cemidday.com/15-anesthesia/experts to find: • Webinar registration link • Group viewing information and technical requirements

• CE webinar processing information

Additional Educational Activities in this Initiative

• This live activity will be archived and offered as web-based on-demand learning at www.cemidday.com

• A web-based activity based on the 2015 Midyear Clinical Meeting “Monitoring and Reversal of Anesthesia: Key Considerations in the Postsurgical Setting” (1.5 hours of CE, please note that individuals who claim CE credit for the live symposium or webinar are ineligible to claim credit for the web-based activities)


http://www.cemidday.com/15-anesthesia/experts

http://www.ashp.org/ClaimCE

http://www.cemidday.com/


Activity Faculty

Tricia A. Meyer, Pharm.D., M.S., FASHP, Activity Chair Regional Director Scott & White Healthcare Associate Professor of Anesthesiology Texas A&M College of Medicine Temple, Texas Tricia A. Meyer, Pharm.D., M.S., FASHP, is Regional Director – Department of Pharmacy at Scott & White Healthcare in Temple, Texas. Dr. Meyer is also Associate Professor of Anesthesiology for the Department of Anesthesiology at the Texas A&M University College of Medicine and Adjunct Associate Professor of Pharmacy Practice at the Texas A&M Irma Lerma Rangel College of Pharmacy.

Dr. Meyer earned her Bachelor of Science degree in pharmacy with honors at the University of Texas in Austin, Texas, Master of Science degree from Texas State University in San Marcos, Texas, and Doctor of Pharmacy degree from Shenandoah University in Winchester, Virginia.

Dr. Meyer has published and presented extensively on the topics of perioperative pharmacy, anesthesia, and post-operative nausea and vomiting. She is a member of ASHP and was recognized as a fellow of ASHP in 2001. Dr. Meyer served as Director at Large for the ASHP Section of Clinical Specialists and Scientists and received the Distinguished Service Award in 2014. She has also served on the Centers for Medicare & Medicaid Services’ Technical Expert Panel for ambulatory surgery same day surgery measures. She is also a member of the Texas Society of Health-System Pharmacists and the Anesthesia Patient Safety Foundation.



Lorri A. Lee, M.D. Professor, Departments of Anesthesiology and Neurological Surgery, and Chief, Division of Neuroanesthesiology Vanderbilt University Medical Center Nashville, Tennessee Lorri A. Lee, M.D., is Professor, Departments of Anesthesiology and Neurological Surgery and Chief, Division of Neuroanesthesiology at Vanderbilt University Medical Center in Nashville, Tennessee. She is also Chair of the Quality and Morbidity and Mortality Improvement Committee in her department and Director for the Center for Evidence-Based Anesthesia. She provides direct patient care for anesthesia primarily for neurosurgical procedures and teaches fellows, residents, SRNAs, and medical students in the operating room.

Dr. Lee is a native of West Virginia where she attended medical school before completing her anesthesiology residency training at the University of Washington in Seattle, Washington. She subsequently rose through the ranks of Assistant to full Professor at the University of Washington prior to her move to Vanderbilt.

Her academic interests are in outcomes research and patient safety. Dr. Lee has worked on the American Society of Anesthesiologists (ASA) Closed Claims Project Committee since 2001 which studies complications related to surgery and anesthesia examining closed anesthesia claims from professional liability companies. Research projects from this group have focused on medication safety, regional anesthesia complications, blindness associated with prone spine surgery, difficult airway management, massive hemorrhage claims, and other topics. Dr. Lee is Co-editor of the Anesthesia Patient Safety Foundation (APSF) Newsletter which is distributed to over 118,000 professionals in the healthcare industry including pharmacists. She is a member of the APSF Executive Committee and Board of Directors. APSF has promoted the concept of STPC – Standardization (ASTM color coding, etc.) – Technology (bar coding, etc.) – Prefilled syringes / Pharmacy – Culture for medication safety in anesthesia. APSF has also highlighted the problem of residual neuromuscular blockade and the multiple contributory factors causing it and methods to prevent it. She has worked with Dr. Tricia Meyer on numerous articles for the APSF Newsletter regarding medication safety issues, including the article on drug shortages and the fungal outbreak associated with the NEC compounding pharmacy and epidural steroid injections. Dr. Lee has worked closely with her local OR pharmacists on several projects including transitioning to pre-filled syringes to better comply with USP <797>. She is heavily involved in quality improvement in the anesthesiology department.

Dr. Lee is a board-certified anesthesiologist and member of the ASA where she serves on the Patient Safety Editorial Board, the Tennessee Society of Anesthesiologists, the Society for Neuroscience in Anesthesiology and Critical Care (SNACC) where she serves on the Scientific Committee, the American Medical Association, the International Anesthesia Research Society, and the Association of University Anesthesiologists.



Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g. employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content.

All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity.

• Tricia A. Meyer is a member of the Anesthesia Patient Safety Foundation.

• Lorri A. Lee is a member of the Anesthesia Patient Safety Foundation (APSF) Executive Committee and Board of Directors, a non-profit organization that receives unrestricted donations from multiple pharmaceutical and anesthesia equipment companies.

• All other planners report no financial relationships relevant to this activity.


CE IN THE MIDDAY

This activity is sponsored by the American Society of Health‐System Pharmacists (ASHP) and planned by ASHP Advantage, a division of ASHP.

Supported by an educational grant from Merck

Ask the Experts: Emerging Agents and Practice Trends for the Monitoring and Reversal of Anesthesia in

Postsurgical Patients

Tricia A. Meyer, Pharm.D., M.S., FASHP, Activity ChairRegional Director Scott & White Healthcare

Associate Professor of AnesthesiologyTexas A&M College of Medicine

Lorri A. Lee, M.D.Professor, Departments of Anesthesiology and Neurological Surgery

Vanderbilt University Medical Center

1.0 CE

Disclosures

• Tricia A. Meyer is a member of the Anesthesia Patient Safety Foundation.

• Lorri A. Lee is a member of the Anesthesia Patient Safety Foundation (APSF) Executive Committee and Board of Directors, a non‐profit organization that receives unrestricted donations from multiple pharmaceutical and anesthesia equipment companies.

• All other planners report no financial relationships relevant to this activity.

Learning Objectives:At the conclusion of this application‐based educational activity, participants should be able to:

1. Discuss new developments and best practices in the monitoring and reversal of specific anesthesia medications or their side effects in the postsurgical setting.

2. Using patient case‐based scenarios develop a plan to manage postoperative nausea and vomiting.

3. Outline components of an effective working relationship between anesthesiology and pharmacy in the operating room.

Residual Neuromuscular BlockadeCase Presentation #1

• 62‐year‐old male with BMI 33 kg/m2, HTN, COPD, OSA• Robotic prostatectomy• Induced with fentanyl 150 mcg,

propofol 200 mg, and rocuronium 70 mg IV

• Surgeons needed complete relaxation with TOF = 0/4 to avoid movement while robot docked

• Additional rocuronium IV throughout case to keep TOF 0/4• Wound closed, TOF weak 1/4 ‐ reversal with 5 mg neostigmine

and 0.8 mg glycopyrrolate IV

BMI=body mass index, HTN=hypertension, COPD=chronic obstructive pulmonary disease, OSA=obstructive sleep apnea, TOF=train‐of‐four

Residual Neuromuscular Blockade

Case Presentation #1 (continued)

• 4/4 TOF with no visible fade; spontaneous ventilation with tidal volume 260 mL, RR 14, SpO2 99% on FiO2 1.0

• Anesthetic turned off• Extubated after coughing on endotracheal tube and eyes open to

voice• Jaw lift in transit to PACU for upper airway obstruction.• SpO2 in PACU 88% ‐> 80% ‐> bag mask ventilation difficult • LMA inserted ‐> SpO2 95%. ABG with PaCO2 89 mmHg.• TOF ratio checked in PACU = 0.6 ‐> reintubated

RR=respiratory rate, PACU=post‐anesthesia care unit, LMA=laryngeal mask airway, ABG=arterial blood gases


Reasons to use neuromuscular blocking agents (NMBAs):

• Facilitates intubation• Prevents patient movement• Allows less anesthetic agent to be used with less impact

on hemodynamics• Allows abdominal muscle relaxation and better

exposure of surgical field• Allows tight closure of abdominal wall• Provides skeletal muscle relaxation for orthopedic

procedures


2. Train‐of‐four (qualitative) (unreliable)Visual, tactile assessment of train‐of‐four nerve stimulation for equal movement/strength or for double burst or tetanic stimulation x 5 seconds

3. Train‐of‐four (quantitative) (more reliable)Electromyography, acceleromyography, kinemyography, phonomyography, mechanomyography (gold standard)Uses TOF ratio.

How Do We Monitor for Residual NMB?(3 options)


1. Clinical signs and symptoms (unreliable)Head or leg lift x 5 seconds, hand grip, tongue depressor, smile, speak, swallow

Residual Neuromuscular BlockadeTOF MONITORS

Residual Neuromuscular BlockadeResidual Neuromuscular BlockadeTOF ratio: 4 supramaximal stimuli to nerve at 2 Hz every 0.5 seconds

• T4:T1 or TOF ratio ‐ compares muscle response (amplitude ‐quantitative) of 4th to 1st stimulus

Degree of fade corresponds to the degree of NMB

• Need at least TOF = 2 before reversal

ampl

itude

1 2 3 4 1 2 3 4

No BlockTOF = 1.0

Non‐depolarizing NMBATOF = 0.3

Murphy G, Brull S. Anesth Analg. 2010; 111:120‐8.

Residual Neuromuscular BlockadeClinical Signs Qualitative TOF Quantitative TOF ratioHead lift x 5 sec TOF ratio = 0.45 – 0.55Ability to swallow TOF ratio = 0.45 – 0.6

Eye opening / ability to speak / tongue thrust

TOF ratio <0.45

Clench teeth TOF ratio = 0.4 – 0.95

Abnormal vision TOF ratio <0.9550 Hz tetanic stimulation TOF ratio ≤0.3

Fade on TOF TOF ratio 0.3 – 0.5Fade with double burst TOF ratio 0.6 – 0.7100 Hz tetanic stimulation x 5 sec

TOF ratio 0.85 (AMG ‐ unreliable);TOF ratio 0.47 (MMG)

Most clinical trials examining postoperative residual paralysis now use a TOF ratio <0.9 to define incomplete neuromuscular recovery; ensures safe tracheal extubation.AMG=acceleromyography, MMG=mechanomyography Murphy G, Brull S. Anesth Analg. 2010; 111:120‐8.


• 3.5% ‐ 64% incidence in recovery room (TOF < 0.9)

• Prolonged recovery room stays

• Associated with increased pulmonary complications• Upper airway obstruction• Hypoxemia• Atelectasis• Pneumonia

Murphy GS et al. Anesth Analg. 2008; 107:130‐7.Berg H et al. Acta Anaesthesiol Scand. 1997; 41:1095‐1103.

Eikermann M. Anesthesiology. 2003; 98:1333‐7.


Residual Neuromuscular BlockadeWhy is this so hard to prevent?

Factors that Increase the Risk of Residual NMB• No quantitative monitoring

‐Clinical signs of reversal unreliable• Inadequate use of monitors; Inadequate monitors• Improper dosing / choice of NMBAs (avoid

pancuronium)• Need for deep block until end of case• Improper use of reversal agents• Patient factors: hypothermia, metabolic acidosis,

hypercarbia, hypoxia, renal or hepatic disease• Use of certain antibiotics (colistin/polymyxin E,

aminoglycosides, tetracyclines, clindamycin) that prolong NMB.

Limitations in the clinical setting:

Acceleromographym (AMG) Significantly different from standard peripheral

nerve stimulator with TOFMajor educational / implementation barriers

Thumb must be freely movableNeed adaptive device for hand to keep constant

position Requires calibrationDuring induction to avoid painAttention diverted from airway

Residual Neuromuscular BlockadeTOF QUANTITATIVE MONITORS

Current Reversal Agents

FDA‐approved NMBA Reversal AgentsDrug Dose

mg/kgTime to peak (min)

Duration of antagonism(min)

Excretion NMBAs reversed

Anticholinesterases

Edrophonium 0.05‐1 1 40‐65 70% renal30% hepatic

rocuronium, vecuronium, pancuronium,cisatracurium, atracurium

Neostigmine 0.03‐0.06 up to 5 mg

7 55‐75 50% renal50% hepatic

rocuronium, vecuronium, pancuronium,cisatracurium, atracurium

Gamma‐Cyclodextrins

Sugammadex 2416

23 ‐ ??1.5

100% renal rocuronium(best),vecuronium

pyridostigmine not clinically used for NMBA reversal because of variability in duration of antagonism from 8‐130 min.

Anticholinesterases(edrophonium, neostigmine)

• Inhibit acetylcholine breakdown to increase concentration of acetylcholine at neuromuscular junction (NMJ)

• Exert potent parasympathomimetic activity (↓ HR, ↑peristalsis, ↑secre. ons, bronchospasm, nausea/vomiting)

• Require co‐administration of anticholinergic (glycopyrrolate or atropine) to block muscarinic / cardiovascular side effects.

Miller’s Anesthesia. 7th ed. 2010: Chapter 29.https://commons.wikimedia.org/wiki/File:The_Muscle_Contraction_Process.png#/

media/File:The_Muscle_Contraction_Process.png

Axon terminal

AChR

Anticholinesterases (edrophonium, neostigmine)

NMBA

Acetylcholine(ACh)


SugammadexRocuronium

SugammadexMechanism of Action• Gamma‐cyclodextrin: 8 sugar ring with negatively charged side chains to

bind the rocuronium molecule

• Structure has a hydrophobic cavity and a hydrophilic exterior. Hydrophobic interactions trap the NMBA into the cyclodextrin cavity, resulting in the formation of a water‐soluble guest–host complex.

https://commons.wikimedia.org/wiki/File:The_Muscle_Contraction_Process.png#/media/File:The_Muscle_Contraction_Process.png

Axon terminal

AChR

rocuronium

sugammadex

Mechanism of Action• Forms a complex with the steroidal NMBAs (rocuronium & vecuronium) and

inactivates NMBA by encapsulating (chelating) the free molecule to form a stable complex

• Affinity: rocuronium > vecuronium >>> pancuronium

• Does not bind non‐steroidal NMBAs (cisatracurium, atracurium)

Sugammadex

TOF = 2 twitches• 2 mg/kg IV – median time to TOF ratio 0.9 = 2 minutes

140 mg for 70 kg patient ‐> one 200 mg vial ~ $84.56*

Post‐tetanic count = 1‐2 twitches• 4 mg/kg IV ‐ median time to TOF ratio 0.9 = 3 minutes

Reversal 3 minutes after administration of 1.2 mg/kg rocuronium• 16 mg/kg – median time to TOF ratio 0.9 = 1.5 min

1120 mg for 70 kg patient ‐> six 200 mg vials = $506.35*

Quicker than spontaneous recovery with succinylcholine

May be useful for “can’t ventilate, can’t intubate” scenario

SugammadexDosing for Rocuronium

*Chambers D et al. Br J Anaesth. 2010; 105:568‐75.

Tricia A. Meyer, Pharm.D., M.S., FASHP

Reversal of Neuromuscular Blockade

• FDA approval 12‐2015 (Approved in Europe in 2008)

• NMBA reversal for rocuronium & vecuronium only, in adults

• Supplied: 100 mg/1 ml, 200 mg/2 ml, 500 mg/5 ml vials

• If exposed to light, vial should be used within 5 days• Incompatible with verapamil, ondansetron and

ranitidine

SugammadexInformation Pharmacists Need to Know

Bridion (sugammadex) prescribing information. Merck & Co, Inc; 2015 Dec.

• Not established in patients <18 years‐old• Not recommended in severe renal impairment• May bind to steroidal hormonal contraceptives –

women should use additional non‐hormonal contraceptive for 7 days

• 0.2% recurarization rate; risk of under‐dosing is incomplete reversal

• No studies for reversal in intensive care unit (ICU)• No data in pregnant women or breast fed infants

SugammadexSafety/Effectiveness



SugammadexPharmacodynamics, Pharmocokinetics

• Sugammadex binds free rocuronium or vecuronium molecules from plasma ‐> favoring movement of remaining free NMBA molecules from NMJ back into plasma, where they are encapsulated

• Capable of reversing any depth of neuromuscular blockade (profound or shallow) induced by rocuronium or vecuronium to a TOF ratio of at least 0.9 within 3 minutes

• Does not bind to plasma proteins; limited metabolism

• Renal elimination (65‐97% of the administered dose is recovered in urine)– 70% of dose excreted within 6 hours; >90% within 24 hours– Avoid in patients with creatinine clearance <30 mL/min

Shields M et al. Br. J. Anaesth. 2006; 96:36‐43. Sorgenfrei IF et al. Anesthesiology. 2006; 104:667‐74. Naguib M. Anesth Analg. 2007; 104:575‐81.


SugammadexSide effects

More common side effects (SEs)• vomiting, pain, nausea, hypotension, and headache

Serious Adverse Events <1%:• Anaphylaxis / anaphylactic shock with range of reactions including

flushing, urticaria, bronchospasm, laryngeal / tongue edema / death possible without prior exposure.

• Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been reported within minutes of administration– Requires close hemodynamic monitoring with administration and possible anticholinergic treatment for significant bradycardia


Which events are associated with residual neuromuscular blockade?

A. Prolonged PACU stays.B. Increased episodes of hypoxemia.C. Postoperative pneumonia.D. Postoperative atelectasis.E. All of the above.

Key Takeaways

Residual NMB• Clinical signs and qualitative TOF monitors are

unreliable for monitoring NMB.

• Residual NMB, defined as a TOF ratio of <0.9, is common and is associated with prolonged recovery times and postoperative pulmonary complications.

• A TOF count of at least 2 should be present prior to reversal.

• Institutions should weigh the benefits, risks and costs associated with NMB monitoring, residual NMB, and NMB reversal agents.

Postoperative Nausea & Vomiting (PONV)

Case Presentation• 62‐year‐old male with BMI 33 kg/m2, HTN, COPD

(smoker), OSA• Robotic prostatectomy• Induced with fentanyl 150 mcg, propofol 200 mg,

and rocuronium 70 mg IV• Post op pain meds immediate post op in PACU ‐

hydromorphone IV push 0.25 mg every 5 minutes as needed

• Anesthesiology providers to determine the patient’s risk factors for PONV and decision to administer antiemetics

BMI=body mass index, HTN=hypertension, COPD=chronic obstructive pulmonary disease, OSA=obstructive sleep apnea


The likelihood of success in implementing guidelines increases when:

• A systematic process is used to identify a well‐developed, evidence‐based guideline

• Appropriate stakeholders are identified and engaged• Guidelines are reviewed with a view of the end user. Are the

recommendations clear and easy to understand? If not, how might you make them so?

• End users should be able to access the evidence easily from point of care. If not, how might it be made accessible?

• The guidelines should be built into current documentation, pre‐printed order sets, etc.

• An evaluation of the implementation is planned and conducted• Additional tools are usually needed. Can you involve those who will

be using them to build the tool if a new one is needed? For example, pocket cards, flow diagrams

Selecting and Implementing Clinical Practice Guidelines in Hospitals. Oakbrook Terrace: Joint Commission on Accreditation of Healthcare Organizations, 2000.

Goals of PONV Guidelines• Who is at risk for PONV in adults? POV in children?• Establish factors that reduce the baseline risks for PONV • Determine the most effective antiemetic monotherapies and

combination therapy regimens for PONV/POV prophylaxis, including pharmacologic and nonpharmacologic approaches

• Ascertain the optimal approach to treatment of PONV and post‐discharge nausea and vomiting (PDNV) with or without PONV prophylaxis

• Determine the optimal dosing and timing of antiemetic prophylaxis

• Evaluate the cost‐effectiveness of various PONV management strategies

• Create an algorithm to identify individuals at increased risk for PONV and to suggest effective treatment strategies.

• Propose a research agenda for future studies

Gan TJ et al. Anesth Analg. 2014; 118:85‐113.

Evidence Risk FactorsPositive overall Female sex

History of PONV or Motion Sickness

Non‐smoking

Younger age

General vs. regional anesthesia Use of volatile anesthetics and nitrous oxide

Postoperative opioids

Duration of anesthesia

Type of surgery (cholecystectomy, laparoscopic, gynecological)

Conflicting ASA physical status

Menstrual cycle

Level of anesthetist’s experience

Muscle relaxant antagonists

Disproven or of limited clinical relevance

BMI Anxiety Nasogastric tubeSupplemental oxygen

Perioperative fasting

Migraine

Risk Factors For PONV In Adults

Gan TJ et al. Anesth Analg. 2014; 118:85‐113.ASA=American Society of Anesthesiologists

Postdischarge Nausea and Vomiting (PDNV) Adult Risk Score

Risk Factors Points

Female sex 1

History of PONV 1

Age <50 years 1

Use of opioids in the PACU

1

Nausea in the PACU 1

Sum 0…5

0

20

40

60

80

0 1 2 3 4 5

Apfel CC et al Anesthesiology. 2012; 117:475‐86. Gan TJ et al. Anesth Analg. 2014; 118:85‐113.PACU=post‐anesthesia care unit

1. Avoidance of general anesthesia (GA) by the use of regional anesthesia

2. Use of propofol for induction and maintenance of anesthesia

3. Avoidance of nitrous oxide 4. Avoidance of volatile anesthetics 5. Minimization of intraoperative and postoperative

opioids6. Adequate hydration

Reduce Baseline Risk


Level of Risk0 RF = 10%1 RF = 10% - 20%2 RF = 30% - 40%3 RF = 50% - 60%4 RF = 70% - 80%

Patient preferencesFear of PONVFrequency of PONV causing headaches/migraine

PONVAdult Risk Factors Children Risk Factors

Patient Related Environmental Surgery >30 minHistory of PONV/motion sickness Postop opioids Age >3 years-oldFemale gender Emetogenic surgery Strabismus surgeryNon-smoker (type and duration) History of POV

relative with PONV

Cost-effectiveness

Consider

Patient risk

LowWait and see

High>2 Interventions/multimodal approach

Reducing baseline risksAvoidance/minimization of:Nitrous oxideVolatile anestheticsPost-op opioids

MediumPick 1 or 2 interventions for adults



Watcha MF et al. Anesthesiology. 1992; 77:162‐84.

Chemoreceptor Trigger Zone

Emetic Center

Area Postrema

Parvicellularreticular

formation

Receptor site

Agonist

Antagonist

Nitrogen mustard

Cisplatin

Digoxin glycoside

Opioid analgesics

Vestibular portion of VIIIth nerve

Mediastinum

5-HT3 Promethazine Atropine Droperidol

N2O

5-HT3 Histamine Muscarinic Dopamine (D2)

?

Pathophysiology of PONV

NK1

CB1

Substance P

Cannabinoids?

?GI tract distensionHigher centers (vision, taste)

Pharynx

Algorithm for Management of PONV

Some of the drugs listed in the algorithm may not have been approved by FDA nor studied in children


Treatment Options• If prophylaxis fails or was not received:

use antiemetic from different class than prophylactic agent

• Readminister only if >6 hours after PACU; do not readminister dexamethasone or scopolamine

Examples: Drug A = Dexamethasone 4 mg in adults. Drug B = Ondansetron 4 mg in adults; possibly consider aprepitant, scopolmine patch. Drug C =Selection may be from other antiemetics (e.g., promethazine). Drug D =Selection may be from other antiemetics (e.g., haloperidol).Given examples are used to illustrate how the algorithm may be actually implemented but may not represent the most favorable approach.

TIVA=total intravenous anesthesia Gan TJ et al. Anesth Analg. 2014; 118:85‐113.

Estimated Risk for (adults) PONV

(e.g., as determined by a risk score)

Low Risk Medium Risk High Risk

Interventions for

Prophylaxis

Drug A Drug A Drug A

+ Drug B or TIVA + Drug B or TIVA + Drug B + TIVA

(In some cases third drug

may be added)

On a case‐by‐case decision: further interventions

Interventions for

Treatment

1. Drug C 1. Drug C 1. Drug C

2. Drug D (in case of

ineffectiveness of treatment in stage 1 (i.e., Drug C)


ineffectiveness of treatment in stage 1 (i.e., Drug C)


ineffectiveness of treatment in stage 1 (i.e., Drug C) Example interventions:

Drug A = Dexamethasone Drug B = Ondansetron Drug C = DroperidolDrug D = HaloperidolGiven examples are used to illustrate how the algorithm may be actually implemented but may not represent the most favorable approach.

Gan TJ et al. Anesth Analg. 2014; 118:85‐113

Risk‐Adapted PONV‐Prevention Algorithm

(with No Prevention in Low‐Risk Patients)

Estimated risk for PONV (e.g., as determined by a risk score)

Low Risk Medium Risk High Risk

Interventions

for Prophylaxis

No prevention (“wait

and see”)

Drug A + Drug B or TIVA Drug A + Drug B + TIVA

On a case‐by‐case decision:

further interventions

Interventions

for Treatment

1. Drug B 1. Drug C 1. Drug C

2. Drug C (in case of

ineffectiveness of treatment in

stage 1) (i.e., Drug B)



stage 1) (i.e., Drug C)



stage 1) (i.e., Drug C)

What is the patient’s risk for PONV?A. 20%B. 40%C. 60%D. 80%

Anesthesia – Pharmacy Teamwork in the Operating Room (OR)


Incorporate a Culture of Medication SafetyOR Medication Safety Specialist

1) Identify errors and high‐risk medication practices 2) Address hazardous conditions with potential for harm and

implement systems to improve medication safety plan for preventing transmission of infectious agents. For example, single use products not used for multiple patients; aseptic prep; USP Chapters <797> and <800>

3) Document and review medication errors, adverse medication events and near misses

4) Educate staff 5) Develop future policies or guidelines to prevent errors in the

future

ASHP Guidelines on Surgery and Anesthesiology Pharmaceutical Services. Am J Health‐Syst Pharm. 1999;56:887‐In progress for revision‐Not approved by ASHP Board of

Directors.

Simplification and Standardizationof Local Anesthetics

• Pharmacy conducted a medication use analysis• 17 different local anesthetics in multiple dosage

forms and various concentrations • 5 of the products were used 93% of the time for all

local anesthetic use• Local anesthetic inventory reduced from 17 to 6• Lower risk of error with decreased number of

choices

OR Manager. 2007; 23:17‐18.

Surface Sampling Anesthesia Carts

Meyer et al. Presented at the American Society of Anesthesiologists Annual Meeting October 13, 2014, A3189.

Pre‐Packaging KitsContents: drug, diluent, directions for mixing,

label, & special suppliesUse for high alert drugs or after hour

preparation

Patient Information Elevating the OR Practice• Preoperative medication history/medication reconciliation

– gather most complete medication history; can help reduce number of missed doses post op

• Pharmacist presence in PACU– Review medications of high risk patients

• Pharmacy services for boarded patients – OR pharmacist to provide same pharmacy services as on unit

• Bedside discharge prescription service • Participation in resuscitation

– Assist in arrest response; familiar with drug libraries, crash carts • Teaching/medication education • Academic involvement

– research, publications, scientific posters, presentations; resident projects• Surgical home

ASHP Guidelines on Surgery and Anesthesiology Pharmaceutical Services. Am J Health‐Syst Pharm. 1999;56:887‐In progress for revision‐Not approved by ASHP Board of Directors.


Safe Injection Practices for Anesthesiology Residents

The media fill test plus observation provides an objective and measurable confirmation of the individual’s capability of aseptically preparing an IV admixture. Findings:• Failure to swab (sterile alcohol swabs) ampules, vials and

injection ports prior to needle entry• Failure to wash hands prior to IV medication preparation• Incorrect opening of syringe, needle packaging• Incorrect use of filter needle with glass ampule• Failure to clean work surface with alcohol or disinfectant

Meyer et al. Presented at the American Society of Anesthesiologists Annual Meeting Oct 12, 2012, A1182.

Anesthesia – Pharmacy Teamwork in the OR

Proactive Team Building• Medication Errors

– Become the resource for the anesthesiology departmental QMMI committee – or become an adjunct member

– Work with anesthesiology department and institution on quick alerts to care providers for potential repetitive drug errors

– Provide input on implementation on QI initiatives regarding medication safety

QMMI=Quality Measurement and Management Initiative, QI= Quality Improvement

• Numerous oversight organizations with recommendations, guidelines, and regulations regarding safe use of anesthesia medications:

• ASA (American Society of Anesthesiologists)• TJC (The Joint Commission)• CDC (Centers for Disease Control and Prevention)• USP (United States Pharmacopeia)• ISO (International Organization for Standardization)• FDA (Food and Drug Administration)

• AAMI (Association for the Advancement of Medical Instrumentation)

• ISMP (Institute for Safe Medication Practices)


ASTM D4774‐311, Standard Specifications for User Applied Drug Labels in Anesthesiology and ISO 26825:2008

Statement on Creating Labels of Pharmaceuticals for Use in Anesthesiology. American Society of Anesthesiologists, October 28, 2015.

Joint Commission Alerts Organizations to Tubing Misconnection Risks #36

Sentinel Event Alert 52 Preventing infection from the misuse of vials

Sentinel Event Alert 11: High‐Alert Medications and Patient Safety

Malignant Hyperthermia

Drills / Protocols


USP–NF General Chapter <797>Pharmaceutical Compounding—

Sterile Preparations

FDA‐enforceable


Controlled substances management


Pharmacy and Therapeutics Committee

• Quality• Cost• Access

–E.g., IV acetaminophen, aprepitant, remifentanil, 5% albumin, recombinant activated factor VII, dantrolene sodium, sugammadex, etc.



Look‐alike drug vials• Shifting suppliers

o Cost containmento Mergers, back‐orders, drug

shortages

Proactive Team Building

• Satellite OR Pharmacy–Keeps pharmacists in‐tune with OR issues–Daily face‐to‐face relationships –Quick trusted resource for anesthesia team–Quick re‐stocking for anesthesia team of

critical medications


Conclusions

• Pharmacists and anesthesiologists collaborate on numerous medication issues with oversight from multiple governing, safety and professional society organizations that are critical to institutional success.

• A good working relationship is essential to safe, efficient, and cost‐effective management of ORs, other procedural areas, and ICUs.




Self-assessment Questions

The presentation self-assessment questions are listed here for your convenience. Note the correct answers for future reference.

1. Which events are associated with residual neuromuscular blockade? a. Prolonged PACU stays. b. Increased episodes of hypoxemia. c. Postoperative pneumonia. d. Postoperative atelectasis. e. All of the above.

2. What is the patient’s risk for PONV? a. 20% b. 40% c. 60% d. 80%.


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