ISMP198 Periop Guidelns FINAL

ISMP Guidelines for
Safe Medication Use

in Perioperative and
Procedural Settings
www.ismp.org
Table of Contents
Funding Source 3
Dedication 3
Introduction and Background 4
Approach to Guideline Development 5
Consensus Building National Summit 6
How to Use the Guideline Statements 6
Ambulatory Surgery Center Opportunities for Safety Enhancements 7
How to Cite the Guidelines 7
Guideline Statements 8
Key Element I: Patient Information 8
Key Element II: Drug Information 9
Key Element III: Communication of Drug Orders and other
Drug Information 10
Key Element IV: Drug Labeling, Packaging, and Nomenclature 10
Key Element V: Drug Standardization, Storage, and Distribution 11
Key Element VI: Medication Delivery Device Acquisition, Use, and Monitoring 14
Key Element VII: Environmental Factors, Workflow, and Staffing Patterns 15
Key Element VIII: Staff Competency and Education 16
Key Element IX: Patient Education 16
Key Element X: Quality Processes and Risk Management 17
Looking Toward the Future of Perioperative Medication Safety 19
Definitions 20
Acknowledgements 24
National Perioperative Medication Safety Summit Sponsors 24
National Perioperative Medication Safety Summit Participants 24
ISMP Staff Contributors 26
ISMP Fellow Contributors 26
References 27
Disclosure 29
About the Institute for Safe Medication Practices 29
© 2022 ISMP Guidelines for Safe Medication Use in Perioperative and Procedural Settings 2
Funding Source
The development of this tool, ISMP Guidelines for Safe Medication Use in Perioperative and Procedural Settings,
has been made possible with funding provided by the US Food and Drug Administration (FDA) under contract
# 75F40119C10120. All material associated with this project represents the position of ISMP and not necessarily
that of the FDA.
DEDICATION
These best practice guidelines are dedicated to the memory of Ronald Litman, DO, ML, ISMP’s
medical director, from 2015-2021. We knew Ron best as our medical director, but he was also a
practicing pediatric anesthesiologist at Children’s Hospital of Philadelphia (CHOP), and Professor
of Anesthesiology and Pediatrics at the Perelman School of Medicine at the University of
Pennsylvania. Ron dedicated his life’s work to enhancing the patient experience and educating the
next generation of providers regarding safe clinical practice, with an eye towards improving the
safety of the medication use process. Ron selflessly gave his own time for work on this grant and
was an unparalleled champion of this project from the very beginning.
Introduction and Background
Harmful medication errors are a significant public health problem, causing at least 1 death every
day and injuring 1.3 million people annually.1 In the perioperative setting, medication errors occur
frequently in all phases of perioperative care and are a common cause of morbidity and mortality.2-4
The frequency of medication errors reported in perioperative settings varies widely depending
on detection and measurement strategies. Studies report frequencies ranging from 1 medication
error in half of all surgical procedures when using observational techniques and record reviews to
detect and identify the errors,5 to as few as 1 error in every 1,285 procedures when relying on self-
reported medication errors.6 A study in one of the few large hospitals that uses BARCODE SCANNING
and audio/visual feedback to verify the drug prior to administration in the OPERATING ROOM (OR)
found as many as 1 error in every 20 medication administrations.5 More than one-third of the errors
led to patient harm, and the remaining two-thirds had the potential to cause harm.
Overall, medication errors are estimated to occur in at least 1 in every 133 doses administered
during anesthesia, alone.7,8 Given 51.4 million inpatient and 53.3 million outpatient surgical
procedures in the US per year, at least 787,218 perioperative medication errors are estimated to
occur annually. These errors can cost healthcare organizations up to $5.6 million every year.9,10
Although surgery is often considered a single event, a patient moves through the entire
perioperative care system during the surgical process, consisting of several different departments,
teams, and medication processes.11 When medication errors occur, they are often the result of the
complexity of care combined with the fast-paced and fragmented nature of perioperative service
delivery.5,12,13
Commonalities and differences can be seen in the types of errors, medications, and contributing
factors associated with medication errors occurring in different perioperative and procedural
locations. In preoperative locations, antibiotics are the most frequent medications involved in errors,
along with patient nonadherence to medication instructions prior to arrival for the procedure.2,14,15
Knowledge deficits, unclear or misunderstood preoperative medication instructions, and errors in
transcription of home medications are the most common contributing factors.15,16
In intraoperative locations such as the OR , analgesics, antibiotics, muscle relaxants, and vasopressors
are most often involved in errors.4,5,14,17,18 In particular, Nanji et al5 noted fentaNYL , propofol, and
phenylephrine to have the greatest incidence of error. Wrong drug errors due to substitution or
syringe swaps, incorrect doses, omissions, and wrong route errors account for up to 70% of all
medication error types that occur in intraoperative locations.3 The medications most often involved
in syringe swaps are muscle relaxants and reversal agents18,19; differences in anesthesia color-
coded syringe labels have not significantly reduced the risk of these errors.19 Haste; distractions;
unlabeled syringes; look-alike appearance of vials, ampules, and labels; knowledge deficits; and
communication problems are the most frequently cited causes of intraoperative errors.2,4,6,8,18,20
Errors in the OR are more prevalent later in the day21,22 and during procedures lasting longer than 6
hours5 due in part to fatigue.14,17
In postoperative locations, antibiotics and anticoagulants are commonly associated with errors20;
antiemetics and anticholinergics are less frequently involved.8,18 The most prevalent contributing
factors are knowledge deficits, known patient allergies, fragmentation of care, and communication
problems that result during transfers of care and changes in healthcare providers.2,4,6,8,18,20-22
Decreased awareness by both patients and physicians of the need to restart medications after
surgery has also led to medication errors.15,16
Approach to Guideline Development
Recognizing some of the unique medication-related challenges associated with perioperative
and procedural locations, ISMP conducted an FDA-funded study in 2019–2022 to identify
and quantify the current state of perioperative medication safety systems and practices
in US hospitals and ambulatory surgery centers (ASCs), and to test whether differences in
organizational demographics significantly influence the level of medication safety. The scope
of this assessment project, the ISMP Medication Safety Self Assessment® for Perioperative Settings
(and subsequent guideline tool development), included perioperative and procedural processes,
staff, equipment, environment of care, and medications associated with medical and/or surgical
procedures that require MODERATE SEDATION, DEEP SEDATION, MONITORED ANESTHESIA CARE
(MAC), REGIONAL ANESTHESIA and/or GENERAL ANESTHESIA , including diagnostic and INVASIVE
PROCEDURES that meet this definition. Excluded were procedures that require only minimal
sedation, or the care of patients after they are discharged from the facility or transferred out of
the perioperative setting to an inpatient bed. Over 385 US facilities (326 hospitals and 60 ASCs)
provided data on their current practices as part of this assessment process.
This national assessment was an essential first step toward understanding a baseline of
practices and improving medication safety in the perioperative setting.23 It can itself be used to
provide knowledge to healthcare providers about best practices. More importantly, it enables
organizations and practitioners to proactively recognize and prioritize gaps in their medication
systems and practices not currently recognized through voluntary medication error reporting
and analysis.24 Organizations are encouraged to proactively understand their current state and
develop necessary action plans based on best practices.25 Nationally, some of the lowest-scoring
Key Elements and Core Characteristics in the assessment identified the lack of redundancies
to detect and correct errors before they reach patients; limits on the complement of qualified
and well-rested practitioners to match the clinical workload; the challenges with procurement,
standardization, and safe use of medication-related devices; and limited abilities to collect and
use essential drug information to make informed decisions.26
Consensus Building National Summit
With early assessment results as a backdrop, ISMP held a two-day national invitational
perioperative summit in November 2021 to discuss priority medication safety-related topics with
clinical experts, representatives from professional organizations, and industry leaders. The goals
for the summit entitled The Future of Perioperative Medication Safety: Charting our Path Forward
were to:
• Examine and gain consensus on the most common modifiable medication use risks in inpatient
and ambulatory perioperative settings.
• Identify and remove barriers to the adoption of proven technologies that support the safe use
of medications in perioperative care settings.
• Develop and communicate best practices associated with the labeling of medications across all
phases of perioperative care (including labeling of outsourced compounded injectables).
Expert faculty provided background for participant dialogue on three priority topics, including
labeling practices, workflow issues that limit the adoption of known safety technologies including
SMART INFUSION PUMPS, and the ability to use BARCODE SCANNING for real-time drug identification
and electronic health record documentation. Upon completion of the summit, participants were
asked to provide input on 33 best practice statements, which were then used as a foundation for
the final set of guidelines.
How to Use the Guideline Statements

Based on the national results from the ISMP Medication Safety Self Assessment® for Perioperative
Settings, literature review, analysis of events reported to the ISMP National Medication Errors
Reporting Program (ISMP MERP), onsite clinical observations by ISMP consultants, and consensus
feedback from a national perioperative summit, ISMP has prioritized 71 best practice statements
that lend themselves to the biggest opportunity for safety improvement. Public comments were
solicited for these statements during a 3 week period where practitioners and organizations were
invited to comment, and necessary revisions were completed.
This set of guidelines is made available to hospitals, ambulatory surgery centers, and other
procedural locations to address identified national gaps in perioperative and procedural
medication safety, providing a steppingstone and support for further implementation of
organization-specific action plans to reduce harmful patient events. Each organization should
regularly evaluate their practices in perioperative and procedural settings. This includes an ongoing
internal process to evaluate safety signals such as reported events, close calls, and hazardous
conditions that threaten the safety of the perioperative process.24 In addition, organizations are
encouraged to seek out and use information about medication safety risks and errors that have
occurred in other organizations and act to prevent similar errors.25,27
Recommendations contained within these guidelines were developed to be used in concert with
other relevant resources, including guidelines and recommendations from Anesthesia Patient
Safety Foundation (APSF), American Society of Health-System Pharmacists (ASHP), the Association
of periOperative Registered Nurses (AORN), and other professional sources, after careful review of
applicable regulatory standards.
Bolded terms in SMALL CAPITAL FONT are described in the Definitions section of the document.
Ambulatory Surgery Center Opportunities
for Safety Enhancements
These guidelines were established with the knowledge that ASCs and other ambulatory
procedural locations are a growing and vital segment of healthcare delivery in the United States.
In recent years, acuity and demand in ASC settings has been increasing, and at times, without
evidence of corresponding growth in dedicated medication error prevention efforts. Many ASC
practitioners who participated in the self assessment and/or reviewed the draft guidelines
reported less staffing and technology resources than practitioners in inpatient perioperative
and procedural care. Due to this disparity, ASC respondents questioned the applicability of
certain statements within these guidelines for their practice.
It is ISMP’s belief that ambulatory sites, including ASCs, performing similar procedures with
similar risk merit the same level of attention to medication safety practices and standards as
acute care facilities. We hope that ASCs and other ambulatory procedural settings will view
these guideline statements as a roadmap and take the opportunity to align themselves with
proven technologies and safety practices identified to limit risk and keep all patients safe during
the medication use process, regardless of practice location.
How to Cite the Guidelines:

Institute for Safe Medication Practices (ISMP.) ISMP Guidelines for Safe Medication Use in
Perioperative and Procedural Settings. ISMP; 2022.
Guideline Statements
KEY ELEMENT I: PATIENT INFORMATION

Essential patient information is obtained, readily available in useful form, and considered
when prescribing, dispensing, and administering perioperative medications, and when
monitoring the effects of these medications.
Statements
1.1 Reconcile medications taken at home by the patient (or administered in the facility) before the medical
and/or surgical procedure with the list of medications prescribed in the perioperative or procedural
setting:
• Before arrival (or no later than the time of admission/encounter)
• Upon transfer within the facility (e.g., from the POST-ANESTHESIA CARE UNIT [PACU] to an inpatient unit)
• At discharge after surgery or a procedure
Any identified discrepancies (e.g., omissions, duplications, contraindications, unclear information) are
resolved as soon as possible.
1.2 On the day of the medical and/or surgical procedure, obtain patient weights measured only in metric
units (e.g., grams or kilograms). Avoid the use of a stated, estimated, or historical weight.28
Exception: Excludes life-threatening situations where the delay involved in weighing the patient could lead to
serious harm (e.g., major trauma).
1.3 Employ a standard organizational process to determine if an adult or pediatric patient is OPIOID-NAÏVE or
OPIOID-TOLERANT, and at high risk for respiratory depression. Document findings in a designated, shared
electronic health record (EHR) location to automate clinical decision support.29-32
1.4 Use continuous electronic monitoring of both oxygenation (e.g., pulse oximetry) and adequacy of
ventilation (e.g., END-TIDAL CARBON DIOXIDE [ETCO2 ] MONITORING [CAPNOGRAPHY]) for patients in
perioperative and procedural settings receiving one or more of the following:
a) MODERATE SEDATION, DEEP SEDATION, MONITORED ANESTHESIA CARE (MAC), and/or GENERAL ANESTHESIA
until facility-defined parameters for recovery have been reached
b) Continuous or intermittent intravenous (IV) or neuraxial opioids (including patient-controlled analgesia
[PCA] or patient-controlled EPIDURAL analgesia [PCEA])
c) REGIONAL ANESTHESIA (e.g., interscalene block) with both a local anesthetic and an opioid
KEY ELEMENT II: DRUG INFORMATION
Essential drug information is readily available in useful form and considered when prescribing,
preparing, dispensing, and administering perioperative medications, and when monitoring the
effects of these medications.
Statements
2.1 Establish and implement safe dosage ranges, taking into consideration patient-related factors such as
age, opioid status, and organ function (e.g., renal impairment, liver impairment), for:
a) Perioperative IV push doses and/or infusions of high-alert medications (e.g., opioids, midazolam,
heparin, insulin, vasopressors, and neuromuscular blocking agents [NMBs])
b) Local anesthetics for peripheral nerve blocks
c) NEURAXIAL ANESTHESIA and/or EPIDURAL injections/infusions
d) Antibiotics
2.2 Create and implement a process to assess for and hold a patient’s current medications (i.e.,
ANTITHROMBOTIC MEDICATIONS, INSULIN), if necessary, prior to a surgical or diagnostic procedure.
Additionally, ensure the process includes a review to restart, retime, or discontinue these same
medications following the procedure.
2.3 Enter preoperative/preprocedural and postoperative/postprocedural orders for medications (including

solutions for hydration) into an EHR with clinical decision support. Have pharmacist(s) (remotely or onsite)
verify these medications orders (including solutions for hydration) before medications are administered.
Exception: This statement excludes medications administered by ANESTHESIA PROVIDERS as part of their
anesthetic management of the patient.
Note: For scheduled procedures, the purpose of electronic order entry and verification is to screen against the
patient’s current medications and medical profile to identify potential allergies, contraindications, interactions,
duplicate therapy, and the accuracy and appropriateness of doses before medications are administered.
2.4 Utilize standard electronic formats, associated with the EHR, for practitioner-and/or procedure-specific
preference cards which are updated and/or approved annually by an interprofessional committee.
Physical and/or handwritten preference cards are avoided.
Note: Preference cards may be used as standing orders if approved as such by the organization. Patient care
orders, including those from preference cards, must be documented in the patient’s medical record.33
2.5 Establish and implement standard policies, protocols, guidelines, and/or order sets to identify, treat, and
monitor postprocedural and/or postoperative patients for signs of hyponatremia, water intoxication, and/
or syndrome of inappropriate antidiuretic hormone (SIADH).
2.6 Establish a protocol and maintain appropriate quantities of drugs required for treating malignant
hyperthermia, based on current reference material from the Malignant Hyperthermia Association of the
United States (MHAUS). This protocol and MHAUS resources, including the hotline phone number, should
be available in all areas of the organization where GENERAL ANESTHESIA is administered (e.g., labor and
delivery, ambulatory surgery centers). Provide regular in situ simulation training for this form of rescue.34
KEY ELEMENT III: COMMUNICATION OF DRUG ORDERS AND OTHER
DRUG INFORMATION
Methods of communicating drug orders and other drug information in the perioperative
setting are streamlined, standardized, and automated to minimize the risk of error.
Statements
3.1 Only accept face-to-face verbal orders from prescribers who are onsite in the facility during emergencies
or during sterile procedures where ungloving would be impractical and jeopardize patient care.
Note: When receiving verbal orders during emergencies or sterile procedures, repeat back medication orders to
the prescriber to confirm the order before administration. Verbal medication orders should include the following:
full medication name, doses digit-by-digit (e.g., “one-five” instead of “15”), unit of measure (e.g., mg, mcg), and
route of administration. Directly enter all verbal orders into the EHR as soon as possible.
3.2 Establish and utilize standard protocols, guidelines, and/or order sets for the management of patients
who receive an IV or neuraxial opioid postoperatively for pain management, which include dosing
guidelines that differentiate between the management of OPIOID-NAÏVE, OPIOID-TOLERANT, and/or HIGH-
RISK PATIENTS, as well as conditions that require dose adjustments.
KEY ELEMENT IV: DRUG LABELING, PACKAGING, AND NOMENCLATURE

Strategies are undertaken to minimize the possibility of perioperative errors with
manufacturer-prepared, pharmacy-prepared, or commercially prepared (e.g., from a
compounding pharmacy or outsourcing facility) drug products that have similar or confusing
labeling/packaging and/or drug names that look and/or sound alike.
Statements
4.1 Strive to configure medication vial storage in medication trays, kits, carts, and/or automated dispensing
cabinets (ADCs) to allow practitioners to immediately view the vial label (i.e., label is facing up) while
selecting medications, instead of a “cap up” storage configuration in which only the top of the vial is
facing up.
4.2 Clearly label storage bins and/or ADC pockets, drawers, kits, and/or trays containing NMBs to clearly
communicate that respiratory paralysis will occur and ventilation is required (e.g., “Warning: Paralyzing
Agent—Causes Respiratory Arrest;” “Warning: Causes Respiratory Paralysis—Patient Must Be Ventilated”).
In addition to the manufacturer’s warning on the caps and ferrules, an auxiliary label may be affixed
directly on each vial.35,36
Readable labels that clearly identify drugs are on all drug containers in the perioperative
setting, and drugs remain labeled up to the point of actual drug administration.
Statements
4.3 Eliminate the use of handwritten labels in perioperative/procedural areas by 2025.
Exception: This excludes medication labels used on the STERILE FIELD. Use sterile, pre-printed medication labels
on the STERILE FIELD, whenever possible.
continued on page 11 >
KEY ELEMENT IV continued from page 10
4.4 Include a machine-readable code (e.g., barcode, radiofrequency identification [RFID]) on all syringe and
infusion labels, including those that are PRACTITIONER-PREPARED, by 2025.
Exception: This excludes medication labels used on the STERILE FIELD. Use sterile, pre-printed medication labels
on the STERILE FIELD, whenever possible.
4.5 Label PRACTITIONER-PREPARED syringes of medications with, at a minimum, the full name, concentration/
dose of the drug, name or initials of the preparing practitioner, as well as an expiration date (when not
used in 24 hours) and time (if expiration occurs in less than 24 hours). Application of an anesthesia color-
coded drug class label alone is not sufficient.
Exception: When allowed by an organizational policy or procedure, syringe labeling is not required if it is
prepared immediately before drug administration, never leaves the hand of the preparer before administration,
and the entire dose in the syringe is immediately administered, or the remaining volume is immediately wasted
or discarded before the syringe leaves the preparer’s hand. A beyond-use date and time are not necessary for
short procedures, as defined by the facility.37,38
4.6 Require labeling, even if only one medication/solution is on the STERILE FIELD.38
4.7 Label containers (e.g., syringes, bowls, cups, basins) with medications and solutions (e.g., lidocaine,
contrast, methylene blue, thrombin) on the STERILE FIELD immediately after filling.38
4.8 Never label an empty syringe, basin, cup, or other container in anticipation of use.37,38
4.9 Verbally and visually confirm all medications delivered to the STERILE FIELD, including medication name,
strength, dosage, and expiration date. This verification is completed by the circulating registered nurse
and surgical technician, or with the licensed professional performing the procedure, if no surgical
technician is available.38
4.10 Immediately discard any unattended, unlabeled medication or solution.38,39
KEY ELEMENT V: DRUG STANDARDIZATION, STORAGE, AND

DISTRIBUTION
IV and REGIONAL ANESTHESIA solutions, drug concentrations, doses, and administration times
are standardized whenever possible.
Statements
5.1 For each patient population (adult, pediatric, and neonatal), establish a limited number of standard drug
and solution concentrations in the perioperative setting for the following:
a) IV medication infusions (e.g., high-alert medications such as opioids, heparin, insulin, vasopressors,
oxytocin, and NMBs)
b) IV hydration infusions
c) REGIONAL ANESTHESIA excluding BOLUS DOSES
d) NEURAXIAL ANESTHESIA
e) Peripheral nerve blocks
f) Parenteral medications used during ophthalmic procedures
g) Irrigations and flush solutions (e.g., heparinized saline)
h) Medications and solutions administered by an ELASTOMERIC PUMP
i) Cardioplegic solutions
KEY ELEMENT V continued from page 11
5.2 Maximize the use of manufacturer-prepared, pharmacy-prepared, or commercially prepared (e.g., from a
compounding pharmacy or outsourcing facility) syringes in the perioperative setting for adult, pediatric,
and neonatal medication doses.
5.3 When no compounding technology is available, or when no pharmacy or pharmacist is available (e.g.,
ambulatory settings), the following recommendations should be considered to safely use compounded
sterile preparations:
• Maximize the use of manufacturer-prepared products
• Purchase products in patient-specific doses that are ready to administer
• If manufacturer-prepared products are not available, investigate the use of commercially prepared
products (e.g., from a compounding pharmacy or outsourcing facility).40,41
Medications are provided to and stocked in perioperative settings in a safe and secure manner
and are available for administration within a timeframe that meets essential patient needs.
Statements
5.4 Segregate, sequester, and differentiate all NMBs from other medications, wherever they are stored in the
organization.
• Eliminate the storage of NMBs in areas of the facility where they are not routinely needed.
• Place NMBs—preferably in a rapid sequence intubation (RSI) kit, in locked-lidded ADC pockets/drawers,
or in a sealed box—in patient care areas where they are needed (e.g., perioperative and facility-defined
procedural locations, labor and delivery units, ambulatory surgery centers).36
5.5 Select, segregate, and secure medications and solutions for injection or irrigation one patient case at a
time, immediately prior to the medical and/or surgical procedure. Medications and solutions for multiple
patient cases are not removed from storage or prepared at the same time.
5.6 Provide benzocaine oral topical anesthetic spray (to suppress the gag reflex) in a metered dose
formulation to limit the duration of each spray and the amount of medication applied, thus lessening the
risk of methemoglobinemia.
Note: Ensure antidotes, reversal agents, and rescue agents are available to be administered if needed. Ensure
coupled order sets and protocols are in place for reference.42-44
5.7 Use vials, or a 2- or 3-liter bag, of sterile water for injection, for the preparation of dantrolene
formulations. Store sterile water vials or bags used in the reconstitution of dantrolene separately from
other IV bag products in the malignant hyperthermia kit or cart.
Note: Avoid the use of 1,000 mL bags of sterile water for injection, irrigation, or inhalation. Accidental infusion of
sterile water may be fatal.34,45
Access to perioperative medications is restricted and controlled.
Statements
5.8 To prevent accidental intravascular injection, whenever possible, delay the placement of clearly labeled
topical thrombin on the STERILE FIELD until after all parenteral products have been administered. If a delay
is not possible, topical thrombin must be sequestered or separated from any parenteral products that are
open or immediately available for use on the STERILE FIELD.
KEY ELEMENT V continued from page 12
5.9 Prioritize the use of PROFILED ADCs in preoperative/preprocedural and postoperative/postprocedural

settings to allow for medication selection after orders have been reviewed and verified by a pharmacist.
Note: Removal of medications via the OVERRIDE function should be reserved for urgent or lifesaving situations in
which a delay would harm the patient.
Note: Anesthesia workstations located in intraoperative or facility-defined procedural areas are commonly NOT
PROFILED and are excluded from OVERRIDE functionality.35,46
5.10 Require a medication order (e.g., electronic, verbal/telephone) or have an approved protocol in effect
prior to removing any medication from storage or from ADCs (if available), even if they are removed using
the OVERRIDE function.
Exception: This statement excludes medications administered by ANESTHESIA PROVIDERS as part of their
anesthetic management of the patient.33,46,47
5.11 If irrigation solutions are not available as manufacturer-prepared or commercially prepared products
(e.g., from a compounding pharmacy or outsourcing facility), ideally have pharmacy prepare, label, and
supply these solutions, for perioperative and procedural settings.
HAZARDOUS DRUGS, chemicals, and potentially flammable products used in the perioperative
setting are safely prepared, dispensed, stored, and administered.
Statements
5.12 Establish and use a protocol to address the safe preparation, handling, transport, storage, administration,
disposal, and management of spills for HAZARDOUS DRUGS used in the perioperative setting.48
5.13 Implement a process for monitoring perioperative and procedural staff who are exposed to HAZARDOUS
DRUGS based on their job duties. A confidential medical surveillance program should be employed that
assesses and documents symptom complaints, physical findings, and appropriate laboratory values.
5.14 Take steps to reduce flammability risks associated with topical skin preparations:
a) Consider the flammability risk when selecting products.
b) Select single-use, properly sized, prefilled applicators of alcohol-based surgical skin prep solutions for
the designated surgical site to prevent pooling and the need for disposal of excess skin prep.
c) Ensure that pooling, spilling, or wicking of a flammable surgical skin prep does not occur during or after
application.
d) Allow adequate drying time of the skin prep before application of drapes or surgical barriers, or before
beginning the procedure (e.g., at least 3 minutes for most alcohol-based skin preps, unless applied to
hairy skin or in body folds, which may take up to 1 hour to dry).
e) Consider including drying times on a SURGICAL SAFETY CHECKLIST to facilitate communication with the
surgical team.
f) Assess the risk of a surgical fire and develop a plan to mitigate. Add a “Surgical Fire Risk Assessment
Score” to the preoperative time-out process that requires the surgical team to identify if flammable
materials (including skin preps and ointments), oxidizers (e.g., supplemental oxygen), and potential
ignition sources will be used during the procedure.49-51
5.15 Use prepackaged phenol applicators that contain a small amount of phenol for use during procedures.
Note: Bulk liquid phenol should be avoided due to increased flammability risk, hazardous material handling
requirements, and potential for confusion with other clear liquids.
KEY ELEMENT VI: MEDICATION DELIVERY DEVICE ACQUISITION, USE,
AND MONITORING
The potential for HUMAN ERROR is mitigated through careful procurement, maintenance,
use, and standardization of devices used to prepare and administer medications in the
perioperative setting.
Statements
6.1 SMART INFUSION PUMP TECHNOLOGY with an engaged DOSE ERROR-REDUCTION SYSTEM (DERS) is
implemented and used in all perioperative and procedural settings, including intraoperatively by
ANESTHESIA PROVIDERS and other practitioners, for the following:
a) Continuous medication infusions
b) Intermittent and secondary infusions
c) REGIONAL ANESTHESIA infusions
d) Patient-controlled analgesia
6.2 Use SMART INFUSION PUMP TECHNOLOGY with an engaged DERS for IV hydrating solutions administered
in perioperative/procedural settings to limit the risk of complications from fluid over-and under-delivery,
especially to volume-sensitive populations (e.g., pediatric or geriatric patient populations).
Exception: Gravity infusions may be used for IV hydrating solutions if they are only used as a flush solution
(CARRIER FLUID) by ANESTHESIA PROVIDERS as part of their anesthetic management of the patient or for emergent
fluid resuscitation.
6.3 Establish organizational expectations for the use of DERS with the goal of maximizing practitioner
compliance to 95% or greater for the administration of all infusions via SMART INFUSION PUMPS (including
EPIDURAL and nerve block infusions).
6.4 Develop and maintain a separate care area in SMART INFUSION PUMP libraries for anesthesia
administration of medication and fluid infusions with tailored dose error-reduction limits.
6.5 Establish and use upper and lower hard limits, that are tailored for specific patient populations (adult,
pediatric, and neonatal) for medication doses, concentrations, infusion rates, LOADING DOSES, and BOLUS
DOSES in SMART INFUSION PUMPS used in the preoperative/preprocedural, intraoperative/intraprocedural,
and postoperative/postprocedural settings.52
6.6 Take steps toward the implementation of bidirectional (i.e., auto-programming and auto-documentation)
SMART INFUSION PUMP interoperability with the EHR in all preoperative/preprocedural, intraoperative/
intraprocedural, and postoperative/postprocedural settings.53
6.7 Establish guidelines to promote the use of activated, audible clinical alarms in perioperative settings that
optimize alarm limits and reduce clinically nonactionable alerts based on data review.54
6.8 LOADING DOSES and/or BOLUS DOSES are never administered via a continuous infusion by simply
increasing the rate of infusion and/or using the basic infusion mode. Use a SMART INFUSION PUMP that
allows programming of the BOLUS DOSE infusion (or LOADING DOSE infusion) and continuous infusion with
separate hard limits for each.55
6.9 Use an interdisciplinary team (e.g., pharmacy, nursing, anesthesia) to transition to the new design
standards (ISO 80369-6) for small neuraxial NRFit connectors used on medical device tubing, reducing the
risk of misconnections.56
6.10 Ensure patient safety is the primary factor considered among others (e.g., effectiveness, usability,
reliability, heuristics, design) when selecting and utilizing specific MEDICATION DELIVERY DEVICES used in
the perioperative and procedural settings. Involve perioperative practitioners in these decisions.
KEY ELEMENT VII: ENVIRONMENTAL FACTORS, WORKFLOW, AND
STAFFING PATTERNS
Medications are prescribed, transcribed, prepared, dispensed, and administered in the
perioperative setting within an efficient and safe workflow and in a physical environment
that offers adequate space and lighting, and allows practitioners to remain focused on the
MEDICATION USE PROCESS without distractions.
Statements
7.1 Proactively assess the perioperative/procedural environment to identify hazardous conditions (e.g.,
interruptions, excess noise, variable temperatures, inadequate lighting, clutter, limited storage space,
inappropriate emphasis on production over safe patient care and procedures) that may contribute to
medication errors. Review the findings to assist with development of effective risk-reduction strategies
to mitigate or prevent hazardous conditions and distractions that might negatively impact safe
medication use.
7.2 Ensure oversight of the MEDICATION USE PROCESS, by a dedicated pharmacist, in perioperative/ procedural
settings.
a) For facilities with a daily onsite pharmacist(s): At least one pharmacist works in the perioperative
area(s) performing clinical activities such as reviewing patient records and drug orders, supporting the
selection, preparation, and administration of drugs; overseeing safe medication storage, managing
controlled substance accountability; and providing perioperative staff and patient education.
b) For facilities without a daily onsite pharmacist(s): A pharmacist regularly conducts medication
safety rounds in perioperative settings, overseeing safe medication selection, storage; preparation,
and administration; managing controlled substance accountability; and providing perioperative
staff education.
The complement of qualified, well-rested practitioners in the perioperative setting matches

the clinical workload without compromising patient safety.
Statement
7.3 Design and follow a fatigue reduction plan for on-call perioperative practitioners and/or those who have
worked overtime that provides adequate recovery time for staff between shifts. This plan provides an
appropriate response when a practitioner feels, or the organization determines, it would be unsafe to
provide care during an immediately subsequent shift due to practitioner fatigue.
KEY ELEMENT VIII: STAFF COMPETENCY AND EDUCATION
Perioperative practitioners receive sufficient orientation to the perioperative MEDICATION USE
PROCESS and undergo baseline and annual competency evaluations of knowledge and skills
related to safe medication practices.
Statement
8.1 Use examples of perioperative/procedural error-prone conditions (e.g., syringe and infusion bag swaps,
unlabeled syringes, problematic medication packages and labels) and adverse events (e.g., emergencies,
oversedation, methemoglobinemia, malignant hyperthermia) as topics for orientation and ongoing
education for perioperative/procedural staff about medication and patient safety.
Practitioners involved in the perioperative MEDICATION USE PROCESS are provided with
ongoing education about perioperative medication error prevention and the safe use of drugs
that have the greatest potential to cause harm if misused.
Statements
8.2 At least quarterly, provide perioperative and procedural staff with information about medication
risks and errors that could impact their practice, including those that have been reported by external
organizations, and provide strategies to minimize these risks and potential for errors.27,57
8.3 Educate perioperative/procedural staff about new drugs added to the formulary and alternative products
due to drug shortages that are specific to perioperative and procedural care. This education includes risks
and hazards that could lead to errors and adverse events, as well as associated risk-reduction strategies.
KEY ELEMENT IX: PATIENT EDUCATION

Patients are included as active partners in their perioperative care and are educated about
their medications and ways to avert errors.
Statement
9.1 Provide preoperative and ongoing education to patients, caregivers, and visitors about the dangers of any
individual other than the patient activating the patient-controlled analgesia (PCA) or patient-controlled
EPIDURAL analgesia (PCEA) button to deliver a medication dose (i.e., PCA by proxy). Ensure a warning label,
“For Patient Use Only,” is visible on the cord or activation button for PCA or PCEA.
KEY ELEMENT X: QUALITY PROCESSES AND RISK MANAGEMENT
A safety-supportive culture (e.g., JUST CULTURE) and model of shared accountability for
safe SYSTEM DESIGN/REDESIGN and safe behavioral choices are in place and supported by
perioperative leaders, managers, and the associated Board of Trustees/Directors.
Statements
10.1 Adopt a safety culture of learning and shared accountability (e.g., JUST CULTURE) in perioperative and
procedural settings that is in alignment with organizational culture to effectively manage SYSTEM DESIGN/
REDESIGN and support safe behavioral choices.
10.2 Define and implement a clear process to resolve conflicts when there is concern or disagreement
about the safety of a medication order or practice that may place a patient at risk. Ensure all
perioperative and procedural practitioners are aware of this process and feel comfortable and
empowered to voice a concern.58
10.3 Actively engage perioperative leaders and managers in regular dialogue about the untoward
consequences of intimidation and promote interdisciplinary respect and cooperation.
Practitioners are motivated to detect and report perioperative adverse events, errors
(including close calls), hazards, and observed AT-RISK BEHAVIORS. Interdisciplinary teams
regularly analyze these reports, as well as reports of perioperative errors that have occurred
in other organizations, to mitigate future risks.
Statements
10.4 Perioperative and procedural practitioners actively participate in organization-wide quality and safety
committees and teams to advance perioperative and procedural medication safety efforts.
10.5 Analyze the perioperative MEDICATION USE PROCESS at least every two years (e.g., using a proactive
risk assessment tool [e.g., www.ismp.org/node/18027]) to identify potential risk factors for medication
errors.
10.6 Proactively investigate known medication risks, hazardous conditions, and close calls to assist in the
development of effective risk-reduction strategies for high-alert medications used routinely in the
perioperative and procedural setting.
10.7 Use multiple sources of information (e.g., data from technology, triggers, drug use evaluations, chart
reviews, safety rounds or observations), in addition to voluntary event reporting sources, to proactively
evaluate the effectiveness of safety strategies and make any necessary adjustments to action plans to
demonstrate sustained improvement over time.
10.8 Employ an interdisciplinary team, including perioperative and procedural practitioners, to analyze data
from SMART INFUSION PUMP TECHNOLOGY (e.g., compliance rate, percent of overridden alerts, percent of
alerts resulting in reprogramming) at least every quarter.52,59
10.9 Track the use of rescue agents, reversal agents, and antidotes (e.g., naloxone, lipid emulsion,
NMB reversal agents) in perioperative and procedural settings to identify risks or errors with
specific medications. Review the data and implement risk-reduction strategies to create sustained
improvement.42
KEY ELEMENT X continued from page 17
Redundancies that support a system of INDEPENDENT DOUBLE CHECKS or automated

verification processes are used for vulnerable parts of the perioperative MEDICATION USE
PROCESS to detect and correct serious errors before they reach patients.
Statements
10.10 Technology vendors should partner with ANESTHESIA PROVIDERS to identify and incorporate
perioperative and procedural workflow in future development of integrated machine-readable coding
(e.g., BARCODE SCANNING, RFID) and documentation systems for use in perioperative and procedural
settings.
10.11 Use machine-readable coding (e.g., BARCODE SCANNING, RFID) in preoperative/preprocedural

and postoperative/postprocedural settings to verify patients and medications/solutions prior to
administration.
10.12 Take steps to implement machine-readable coding (e.g., BARCODE SCANNING, RFID) in intraoperative/
intraprocedural workflows to confirm medication/solution selection prior to administration.
10.13 Take steps to implement and integrate machine-readable coding (e.g., BARCODE SCANNING, RFID) to
support real-time EHR documentation of medication doses and fluid administration in all preoperative/
preprocedural, intraoperative/intraprocedural, and postoperative/postprocedural settings.59
Proven infection prevention practices are followed in perioperative settings when storing,
preparing, and administering medications.
Statements
10.14 Do not administer medications from a single syringe to multiple patients, even if the needle or cannula
on the syringe is changed.61
10.15 Do not administer medications from single-dose vials or ampules to multiple patients or combine
leftover contents for later use.61
10.16 In all perioperative clinical care areas, NEVER use IV solutions intended for infusion, including minibag
solutions, as common source containers to prepare IV flush syringes or to dilute or reconstitute
medications for one or more patients.62
10.17 Employ organizational practices for compounding sterile preparations in all perioperative and
procedural settings that follow USP standards and applicable regulations and guidelines.40
Looking Toward the Future of Perioperative
Medication Safety
There were several areas of identified risk for which consensus could not be reached during the summit or
subsequent discussions, but merit attention for future medication safety work including the following:
Lack of consensus/agreement on the content and sequencing of drug

information displayed on labels used in perioperative settings
ISMP supports the use of USP General Chapter <7> Labeling standards recommending for “injectable drug
products greater than 1 mL, whether packaged in single- or multiple-dose containers, the quantity per total
volume should be the primary and prominent expression on the principal display panel of the label, followed
in close proximity by quantity per milliliter enclosed by parentheses (quantity/mL).”63 The American Society
of Anesthesiologists (ASA) syringe labeling standards suggest “the drug’s generic name and concentration (in
units per mL) should be the most prominent items displayed on the label of each syringe.” ASA vial and ampule
labeling standards suggest “medication containers intended for use in the practice of anesthesiology display
the generic name and concentration (as the total amount of medication in the container divided by the total
volume) most prominently. Preferably, the concentration in units per mL is also displayed.”64
Variability in dose expression on medication labels has historically led to error. When the label prominently
displays the dose/mL, practitioners have inadvertently administered the entire vial or syringe, believing that
was the entire content, and at times resulting in serious harm. Having two different labeling practices in
healthcare facilities adds to risk, especially when practitioners must read labels with two different formats. It
is also unreasonable to expect that there would be two separate inventories of products—one for anesthesia
use—and one for all other practitioners.64
Limited adoption of medication-related technology and safety resources

Intraoperative settings
Due to their documented medication safety benefits, BARCODE SCANNING for medication selection,
administration, and documentation and SMART INFUSION PUMP TECHNOLOGY have become standard practice
in the majority of US healthcare facilities, yet ANESTHESIA PROVIDERS are underrepresented in their use. This
limited adoption of medication safety-related technologies, most notably in intraoperative settings, is best
illustrated by demographic results from the ISMP Medication Safety Self Assessment® for Perioperative Settings.26
Many providers believe that the differences in anesthesia workflow merit a different solution. In some cases,
industry has not been known to identify these differences or include ANESTHESIA PROVIDERS in innovations that
support this unique workflow. We encourage continued study and innovation regarding the use of medication
safety-related technologies (e.g., SMART INFUSION PUMPS, BARCODE SCANNING) involving ANESTHESIA PROVIDERS
to support medication safety advancement in the perioperative space.
ASCs and ambulatory settings

As acuity and patient volumes continue to increase in outpatient settings, medication safety principles and
medication safety-related technologies need to be incorporated at an equal rate. Opportunities exist to apply
the knowledge and experience gained from medication safety practices in inpatient perioperative care as
organizations seek to extend their services to ambulatory care settings. Additional resources will likely be
required to fully adopt and maintain equivalent medication safety technology standards that apply to all
perioperative and procedural care areas. ISMP encourages the implementation of an EHR, SMART INFUSION
PUMP TECHNOLOGY, and BARCODE SCANNING in all perioperative and procedural settings to support reliable
care regardless of location.
Definitions
ANESTHESIA PROVIDER(S): A licensed practitioner ingredient is selected prior to compounding a
(e.g., anesthesiologist, certified registered nurse preparation; or the correct medication is retrieved
anesthetist [CRNA], certified anesthesiologist from or stocked in the correct storage location. The
assistant) who is trained, qualified, and authorized process involves the use of a barcode scanner, an
within the organization to plan and administer electrical device that can read and output printed
MAC, DEEP SEDATION, GENERAL ANESTHESIA , and/ barcodes to a computer.
or REGIONAL ANESTHESIA ; monitor sedated and/or
anesthetized patients during procedures; support BASAL INFUSION: A continuous infusion of an opioid
patients’ vital functions inclusive of hemodynamic and/or local anesthetic to provide a constant level of
stability and airway management during procedures; analgesia, which may also be administered as BOLUS
and diagnose and treat pathologic changes and DOSES, PCA, or PCEA.
other clinical problems that might occur during the
perioperative period. BOLUS DOSE(S): A discrete dose of medication or fluid
given in a set volume at the desired infusion rate or
ANTITHROMBOTIC MEDICATION(S): Includes for a specified duration prior to (see LOADING DOSE)
anticoagulants (e.g., vitamin K antagonists [warfarin], or during a continuous infusion.
heparin(s) [unfractionated heparin, low molecular
weight heparin]); factor Xa inhibitors (e.g., apixaban, CARRIER FLUID (also called a “medication line”): A
betrixaban, edoxaban, fondaparinux, rivaroxaban); small bag of sterile, nonpyrogenic crystalloid fluid
direct thrombin inhibitors (e.g., argatroban, used to help deliver and flush the administration
bivalirudin, dabigatran); thrombolytics (e.g., set used to administer small volume IV medications
alteplase, tenecteplase); and antiplatelet medications or an IV medication titrated to effect. The CARRIER
(e.g., aspirin, clopidogrel, dipyridamole, prasugrel, FLUID may be administered simultaneously with
ticagrelor, cangrelor, ticlopidine). medication infusions or used before and/or after
infusions to ensure any residual incompatible
AT-RISK BEHAVIOR(S): Behavioral drift that occurs solution has been cleared from the administration
over time in all humans after successful violations set or any residual medication left in the tubing has
(no adverse outcomes) of a rule; a behavioral been administered to the patient.
choice that increases risk where the risk is not
recognized or mistakenly believed to be insignificant DEEP SEDATION: A drug-induced depression of
or justified. AT-RISK BEHAVIORS often occur when consciousness during which patients cannot be
individuals knowingly violate policies, procedures, easily aroused but respond purposefully following
or generally accepted practices in order to work repeated or painful stimulation. The ability to
around unexpected problems and system failures independently maintain ventilatory function may
to accomplish their work in the moment. Examples be impaired. Patients may require assistance in
include bypassing a duplicate therapy alert during maintaining a patent airway, and spontaneous
order entry without consideration; technology ventilation may be inadequate. Cardiovascular
workarounds; removing more than one patient’s function is usually maintained.
medications from an ADC prior to administration;
and written orders or documentation that include DOSE ERROR-REDUCTION SYSTEM(S) (DERS): Refers to
error-prone abbreviations. The just response to AT- the integral computer software in SMART INFUSION
RISK BEHAVIOR is to investigate the source and scope PUMPS intended to aid in the prevention of infusion
of the behavior; remove any barriers to the desired programming-related errors and warn users of
safer choice; and coach (not discipline) individuals to potential over- or under-delivery of a medication
see the significant risk associated with their behavior or fluid by checking programmed doses/rates
and to choose more appropriate, safer alternatives. against facility-configurable preset limits specific
to a medication/fluid, and to a clinical application
BARCODE SCANNING: The use of optical machine- (e.g., EPIDURAL administration) and/or location (e.g.,
readable representation of data found in barcodes neonatal intensive care unit, medical/surgical unit).
on medication packages and patient identification
bands to verify that the correct patient is receiving
the correct medication; the correct solution or
DEFINITIONS continued from page 20
ELASTOMERIC PUMP(S): A device (e.g., Ambu® progesterone, and zidovudine; and drugs with
ACTion™ Fuser Pain Pump, ON-Q* Pump) used after reproductive hazards, such as dronedarone,
certain procedures to intermittently or continually fluconazole, and oxytocin. USP General Chapter
infuse medications, typically local anesthetics, at a <800> provides standards for safe handling
specific rate into the tissues around an incision. The of HAZARDOUS DRUGS to minimize the risk of
medication is held in a stretchable balloon reservoir exposure to healthcare personnel, patients, and
(medication reservoir ball), and pressure from the the environment. These standards describe the
elastic walls of the balloon drives the medication responsibilities of personnel handling HAZARDOUS
delivery, rather than gravity. DRUGS; facility and engineering controls; procedures
for deactivating, decontaminating, and cleaning; spill
END-TIDAL CARBON DIOXIDE (ETCO2) MONITORING control; and documentation.48
(CAPNOGRAPHY): Breath-by-breath measurement
of the amount of carbon dioxide (CO2) in exhaled HIGH-RISK PATIENT(S) (for respiratory depression):
air, which assesses ventilation and provides A pediatric or adult patient receiving a central
an early warning about a worsening trend in a nervous system depressant (e.g., general anesthetic,
patient’s condition caused by hypoventilation, sedative, opioid) who has risk factors that increase
hyperventilation, increased metabolic activity, the likelihood of respiratory depression and
decreased cardiac output, and/or poor pulmonary associated adverse outcomes:
perfusion. • Age less than 6 months or greater than 55 years
• Obesity
EPIDURAL OR EPIDURAL ANESTHESIA: A technique
of managing pain in the thoracic, lumbar, or sacral
• Hepatic or renal impairment
areas without the loss of consciousness, in which • Known or suspected sleep-disordered breathing
(e.g., snoring, upper airway resistance syndrome,
an opioid and/or anesthetic is injected or infused obstructive sleep apnea-hypopnea syndrome)
into the peridural space through an indwelling
catheter. Administration may be a single injection, • Large neck circumference
a continuous BASAL INFUSION, or self-administered • Anatomical maxilla or mandible abnormalities
(patient-controlled) within programmed limits. • Prolonged surgery (greater than 2 hours)
• Thoracic or upper abdominal surgical incisions
GENERAL ANESTHESIA: A drug-induced loss of that may impair adequate ventilation
consciousness during which patients are not • Pulmonary or cardiac disease or dysfunction
arousable, even by painful stimulation. The ability or major organ failure
to independently maintain ventilatory function is • Congenital central hypoventilation syndrome
often impaired. Patients often require assistance in (pediatrics)
maintaining a patent airway, and positive pressure • Myasthenia gravis
ventilation may be required because of depressed
spontaneous ventilation or drug-induced depression
• Ultra-rapid drug metabolism (genetic
polymorphism)
of neuromuscular function. Cardiovascular function
may be impaired. • Smoker
• Concomitant administration of sedating agents
HAZARDOUS DRUG(S): According to the National • High opioid dose requirements
Institute for Occupational Safety and Health (NIOSH) • History of naloxone administration
List of Antineoplastic and Other Hazardous Drugs
in Healthcare Settings, drugs are considered HUMAN ERROR(S): Inadvertently doing something
hazardous if it exhibits one or more of the other than what should have been done; a mental
following characteristics in humans or animals: slip, lapse, or mistake, such as miscalculating a dose,
carcinogenicity, teratogenicity or developmental forgetting to dilute a medication, or transposing
toxicity, reproductive toxicity, organ toxicity at low the doses of two antibiotics while prescribing the
doses, genotoxicity, or structure and toxicity profiles medications. HUMAN ERRORS are unintentional
of new drugs that mimic existing HAZARDOUS acts, not behavioral choices; thus, the just response
DRUGS. Examples of HAZARDOUS DRUGS used in the to HUMAN ERROR is to console the individual and
perioperative setting include antineoplastic drugs to investigate system redesign to prevent/reduce
such as fluorouracil, gemcitabine, methotrexate, recurrence.
and mitoMYcin; non-antineoplastic drugs that
meet other NIOSH criteria, such as azaTHIOprine,
carBAMazepine, estrogen creams, fosphenytoin,
INDEPENDENT DOUBLE CHECK(S)/INDEPENDENTLY MODERATE SEDATION: A drug-induced depression

DOUBLE CHECKED: A procedure in which two of consciousness during which patients respond
individuals, preferably two licensed practitioners, purposefully to verbal commands, either alone
separately check each component of the work or accompanied by light tactile stimulation. No
process. An example would be one person interventions are required to maintain a patent
calculating a medication dose for a specific patient airway, and spontaneous ventilation is adequate.
and a second individual independently performing Cardiovascular function is usually maintained.
the same calculation (not just verifying the MODERATE SEDATION should be performed by a
calculation) and matching the results. qualified individual, separate from the proceduralist,
so that vital functions can be continuously
INVASIVE PROCEDURE(S): A procedure that monitored and supported.
penetrates the protective surfaces of a patient’s
body, generally requiring entry into a body cavity MONITORED ANESTHESIA CARE (MAC): A specific
and/or insertion of an indwelling foreign body; is anesthesia service used for medical and/or surgical
performed in an aseptic surgical field; and requires procedures in which a qualified ANESTHESIA
MODERATE SEDATION, DEEP SEDATION, MAC, REGIONAL PROVIDER continually monitors and supports the
ANESTHESIA , and/or GENERAL ANESTHESIA of the patient’s vital functions; diagnoses and treats
patient to perform. Procedures that do not require clinical problems that occur; administers sedative,
sedation or anesthesia as listed above are not anxiolytic, or analgesic medications to achieve
included in this definition. varying levels of sedation, awareness, and analgesia;
and converts to GENERAL ANESTHESIA if required.
JUST CULTURE: Refers to a safety-supportive model of
shared accountability where healthcare institutions NEURAXIAL ANESTHESIA: A type of REGIONAL
are accountable for the systems they design, for ANESTHESIA (excluding peripheral nerve blocks)
supporting the safe behavioral choices of patients, that involves injection of one or more opioids
visitors, and staff, and for responding to staff and/or anesthetic medications by the EPIDURAL
behaviors in a fair and just manner. In turn, staff or intrathecal (spinal) routes of administration
are accountable for the quality of their behavioral to manage pain in the thoracic, lumbar, or sacral
choices (HUMAN ERROR is not a behavioral choice) and region, without loss of consciousness. NEURAXIAL
for reporting their errors and system vulnerabilities. ANESTHESIA includes EPIDURAL ANESTHESIA and
spinal anesthesia.
LOADING DOSE(S): The initial dose of a medication
given by infusion or syringe that is intended to OPERATING ROOM(S): A specially equipped room that
rapidly achieve a therapeutic level prior to initiating meets the requirements of a restricted area and is
the continuous infusion or scheduled maintenance designated and equipped for performing medical
dose infusion. and/or surgical procedures that require an aseptic
field. Any form of anesthesia may be administered
MEDICATION DELIVERY DEVICE(S): An instrument/ in an OPERATING ROOM as long as appropriate
equipment used to administer medications and anesthesia gas administration devices and exhaust
solutions, including programmable large volume systems are provided. A hybrid OPERATING ROOM is
and syringe infusion pumps, PCA pumps, EPIDURAL included in this definition (an OPERATING ROOM that
infusion pumps, implantable pumps, ELASTOMERIC has permanently installed equipment [not portable
PUMPS, drug-eluting stents, pen devices that contain imaging technology] to enable diagnostic imaging
medication (e.g., EPINEPHrine, insulin), oral or before, during, and after medical and/or surgical
ENFit syringes, parenteral syringes, needles, and procedures).
dosing cups.
OPIOID-NAÏVE (adult patient): Patients who do NOT
MEDICATION USE PROCESS: A series of clinical tasks meet the definition of OPIOID-TOLERANT, and thus
and sub-tasks for managing the information, have NOT been receiving, for 1 week or longer, at
environment, and human resources associated with least: 60 mg oral morphine/day; 25 mcg transdermal
all phases of medication use, including medication fentaNYL/hour; 30 mg oral oxyCODONE/day;
procurement, prescribing, preparation, dispensing, 8 mg oral HYDROmorphone/day; 25 mg oral
administration, and patient monitoring. The oxyMORphone/day; 60 mg oral HYDROcodone/day;
MEDICATION USE PROCESS consists of ISMP’s Key or an equianalgesic dose of another opioid, including
Elements of the Medication Use System™ (https://www. heroin and/or non-prescribed opioids.29-32
ismp.org/key-elements-medication-use) that form a
framework for managing medication use safely. continued on page 23 >
OPIOID-TOLERANT/OPIOID TOLERANCE (adult patient): SMART INFUSION PUMP(S)/SMART INFUSION PUMP

OPIOID TOLERANCE is defined by the following TECHNOLOGY: An infusion pump with integral
markers: Patients receiving, for 1 week or longer, at computer software (see DOSE ERROR-REDUCTION
least: 60 mg oral morphine/day; 25 mcg transdermal SYSTEMS) that is, at a minimum, capable of:
fentaNYL/hour; 30 mg oral oxyCODONE/day; 1) maintaining a drug library of standard drug
8 mg oral HYDROmorphone/day; 25 mg oral concentrations, which, when enabled, is used to
oxyMORphone/day; 60 mg oral HYDROcodone/day; support dose calculations and alert the user to
or an equianalgesic dose of another opioid, including incorrect orders, calculation errors, or programming
heroin and/or non-prescribed opioids.29-32 errors that would result in significant over- or
under-delivery of a drug, electrolyte, or other
OVERRIDE: A process of bypassing the pharmacist’s fluid; and 2) capturing administrative infusion
review of a medication order to obtain a medication data in a systematic, objective manner to support
from a PROFILED ADC when assessment of the improvement in medication use. If the programmed
patient indicates that a delay in therapy would dose is outside the preset limits, the pump alerts
harm the patient. clinicians and can either require confirmation before
beginning delivery (soft limit) or not allow delivery
POST-ANESTHESIA CARE UNIT(S) (PACU): A unit (hard limit).
(sometimes called the recovery room or area) that
provides a safe environment where immediate care STERILE FIELD: The area surrounding the site of the
of patients who have undergone a medical and/ incision or perforation into tissue, or the site of
or surgical procedure can be closely monitored introduction of an instrument into a body orifice
by specially trained practitioners for the return of that has been prepared for an INVASIVE PROCEDURE.
protective airway reflexes and early recognition The area includes all working areas, furniture, and
and treatment of anesthesia and/or procedural side equipment covered with sterile drapes and drape
effects and instability, including airway compromise, accessories and all personnel in sterile attire.65
respiratory depression, bleeding and other
hemodynamic instability, nausea, vomiting, delirium, SURGICAL SAFETY CHECKLIST: A tool similar to that
and pain control. created by the World Health Organization (WHO)
(www.ismp.org/ext/655), designed to improve
PRACTITIONER-PREPARED: Refers to medications the safety of medical and/or surgical procedures
and/or solutions prepared (e.g., drawn into a by bringing together the whole procedural team
syringe, poured into cups or basins) by ANESTHESIA (surgeons, ANESTHESIA PROVIDERS, anesthesia
PROVIDERS, surgeons, nurses, or other practitioners personnel, and nurses) to perform key safety checks
in the perioperative setting, outside of the pharmacy during vital phases of perioperative care: prior to
and/or outside of a biological safety cabinet/laminar the induction of anesthesia (“sign in”), prior to skin
flow hood. incision (“time-out”), and before the team leaves the
OPERATING ROOM.
PROFILED ADC(S): Functionality that allows an
ADC to be interfaced with the pharmacy computer SYSTEM DESIGN/REDESIGN: Refers to the design/
system and EHR, thereby restricting the removal redesign of processes, procedures, equipment,
of a medication from the ADC until after a interfaces, overall structure, and the environment or
pharmacist has verified the safety of the order. conditions under which staff work, for the purpose
Once pharmacy verification has occurred, a of satisfying specific requirements, such as patient
practitioner can select the medication from a safety. The design of a system dictates how reliable
patient-specific list on the ADC screen and it is in terms of satisfying specific requirements.
remove the medication from the ADC.
REGIONAL ANESTHESIA: Refers to peripheral nerve

blocks as well as all NEURAXIAL ANESTHESIA , including
EPIDURAL ANESTHESIA and spinal anesthesia.
Acknowledgements
National Perioperative Medication Safety Summit Sponsors
ISMP is grateful to the following organizations that provided support for the National Perioperative Medication
Safety Summit.
National Perioperative Medication Safety Summit Participants
Racheal Adams, PharmD Franchesca Charney, RN, MS, CPHRM, CPPS,

SCA Pharmaceuticals CPSO, DFASHRM
American Hospital Association/ASHRM
Mary Alexander, MA, RN, CRNI, CAE, FAAN
Infusion Nurses Society Beth Clayton, DNP, CRNA, FAANA, FAAN
University of Cincinnati; University of Cincinnati
Mary Baker, PharmD, MBA, FASPEN
Physicians
Pfizer
Daniel Cole, MD
John Beard, MD, MBA
Anesthesia Patient Safety Foundation
ICU Medical
James Cole, RPh, MBA
Lynn Bichajian, MD
Pfizer
Acacia Pharma, Inc.
Andrea DiPietro, PharmD, RPh
Richard Botney, MD
Nemours Children’s Hospital, Delaware
Julie Boytim, DNP, CRNA
Rosemary Duncan, PharmD, BCPS
Performance Anesthesia Services
The Johns Hopkins Hospital
Mary Pat Bulfin, PharmD, BCPS
Ludwik Fedorko, MD, D.Phil, FRCPC
Cleveland Clinic
University Health Network, Toronto General
Mary Burkhardt, MS, RPh, RASHP, FSMSO Hospital
Veterans Administration (VA) National Center for
Michael Ganio, PharmD, MS, BCSCP, FASHP
Patient Safety
American Society of Health-System Pharmacists
Julie Cahn, DNP, RN, CNOR, RN-BC, ACNS-BC, CNS-CP (ASHP)
Association of periOperative Registered Nurses (AORN)
SUMMIT PARTICIPANTS continued from page 25
Eliot Grigg, MD Misti Spann, PharmD

University of Washington / Seattle Children’s USP
Hospital
Erin Sparnon, MEng
Allison Hanson, PharmD, BCPS, FISMP ECRI
Baxter Healthcare
James Stevenson, PharmD, FASHP, FFIP
Shannon Johnson, PharmD, CPHIMSS Omnicell Inc.
Becton Dickinson
Susan Stolz
Mike Kolberg, BSME Fresenius Kabi
Codonics, Inc.
Tina Suess, MHA, BSN, RN - BC, CPHIMS, CPPS
Palak Lee, MBA Penn Medicine Lancaster General Hospital
Becton Dickinson
Brian Swift, PharmD, MBA
Lauren M.Y. Lobaugh, MD, MAS, FAAP Thomas Jefferson University Hospital
Baylor College of Medicine
Nasim Tanner
Texas Children’s Hospital
Omnicell Inc.
Constance Long, MBA
Tim Vanderveen, BS Pharm, PharmD, MS
Hikma Pharmaceuticals
Representing Association for the Advancement of
Gee Mathen, BS Medical Instrumentation (AAMI)
Texas Children’s Hospital
Gwen Volpe, RPh, LSS, BB, FASHP
Patricia McGaffigan, RN, MS, CPPS Fresenius Kabi
Institute for Healthcare Improvement
Elizabeth Wade, PharmD, BCPS, FASHP
Tricia Meyer, PharmD, MS, FASHP, FTSHP Concord Hospital
Texas A&M College of Medicine
Deborah Wagner, PharmD, FASHP
Baylor Scott & White Medical Center – Temple
Michigan Medicine
Cindy Mitman, PharmD, MBA
Joyce Wahr, MD
Hikma Pharmaceuticals
University of Minnesota
Binhminh Nguyen, PharmD
Ari Weintraub, MD
Beth Israel Deaconess Needham
Children’s Hospital of Philadelphia
Shawn O’Connell, RN, MS
Kathy Wilson, RN, MHA
B. Braun Medical
ASC Quality Collaboration
Lynda Olson, PharmD
Scott Winiecki, MD
ICU Medical
Center for Drug Evaluation and Research, FDA
Ed Pollak, MD, FASA, CPPS
Rachel Stratman Wolfe, PharmD, MHA, BCCCP
Henry Ford Hospital and Health System
Barnes-Jewish Hospital
Andy Poole, FACHE
Pamela Wrobleski, CRNA, RN, DNAP
ECRI
AANA; BPW Medical Associates
Danny Pugliesi, RN, CPHIMS
Nicole Yin, PharmD
Baxter Healthcare
M Health Fairview / University of MN Medical Center
Elizabeth Rebello, MD
UT MD Anderson Cancer Center
James Russell, BS-Pharm, RPh
Epic
Nathaniel Sims, MD
Massachusetts General Hospital
Sheldon S. Sones, RPh, FASCP, BS Pharm
Sones and Associates
ISMP Staff Contributors
Shannon Bertagnoli, PharmD, BCPPS
Renee Brehio
Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP
Sharon Dicker
Michael J. Gaunt, PharmD
Jennifer L. Gold, MSN, RN
Matthew Grissinger, RPh, FISMP, FASCP
Rita K. Jew, PharmD, MBA, BCPPS, FASHP
Arounsavanh Khemdy
Rebecca Lamis, PharmD, FISMP
Michelle Mandrack, MSN, RN
Christina Michalek, BS, RPh, FASHP
Susan Paparella, MSN, RN
Jordann Rufo
Ann D. Shastay, MSN, RN, AOCN
Lisa Shiroff
Kelley Shultz, MD
Judy Smetzer, BSN, RN
Allen Vaida, PharmD, FASHP
ISMP Fellow Contributors

Emily B. Holcomb, PharmD, MBA, BCPS
Neha Kumar, PharmD, FISMP
Bennet Ninan, PharmD, FISMP
Wykeem Parker, BS, PharmD
Myungsun (Sunny) Ro, MS, PharmD
Samuel Suen, PharmD
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impact of coloured syringe labels. Can J Anaesth. 2000;47(11):1060-7. threatens patient safety. ISMP Medication Safety Alert! Acute Care.
2022;27(7):1-5.
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36. Institute for Safe Medication Practices (ISMP). Best Practice 7. In: Infrastructure. In: ISMP Guidelines for Optimizing Safe
ISMP Targeted Medication Safety Best Practices for Hospitals. ISMP; Implementation and Use of Smart Infusion Pumps. ISMP; 2020.
2022. Available at: https://www.ismp.org/guidelines/best- Available at: https://www.ismp.org/guidelines/safe-
practices-hospitals. Accessed June 13, 2022. implementation-and-use-smart-pumps . Accessed June 13, 2022.
37. Joint Commission. Hospital Program, Medication Management 53. Institute for Safe Medication Practices (ISMP). Section 5.
Chapter, MM.05.01.09: Medications are Labeled. Element of Bi-directional smart infusion pump interoperability with the EHR.
Performance 1. In: Comprehensive Accreditation Manual. Joint In: ISMP Guidelines for Optimizing Safe Implementation and Use of
Commission Resources; 2021, Jul 1. Accessed August 30, 2021. Smart Infusion Pumps. ISMP; 2020. Available at: https://www.ismp.
38. Joint Commission. NPSG.03.04.01, Element(s) of Performance 1 org/guidelines/safe-implementation-and-use-smart-pumps.
– 8. In: National Patient Safety Goals, Effective January 2022 for Accessed June 13, 2022.
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org/-/media/tjc/documents/standards/national-patient-safety- Insights for Health System-News. 2020 Feb 19. Available at: https://
goals/2022/npsg_chapter_hap_jan2022.pdf. Accessed June 13, www.ecri.org/components/HRCAlerts/Pages/alarms.aspx.
2022. 55. Institute for Safe Medication Practices (ISMP). Section 4. Clinical
39. Institute for Safe Medication Practices (ISMP). Section 4. Labeling. workflow. In: ISMP Guidelines for Optimizing Safe Implementation
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Accessed June 13, 2022. pumps. Accessed June 13, 2022.
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practices for sterile compounding. In: ISMP Guidelines for Sterile route medication errors. Paediatr Anaesth. 2018;28(1):8-12.
Compounding and the Safe Use of Sterile Compounding Technology. 57. Centers for Medicare & Medicaid Services. §416.43(c) Standard:
ISMP; 2022. Available at: https://www.ismp.org/resources/ Quality Assessment and Performance Improvement: Program
guidelines-sterile-compounding-and-safe-use-sterile- Activities. In: Internet-Only Manual (IOMs). State Operations Manual
compounding-technology. Accessed June 13, 2022. (100-07), Appendix L – Guidance for Surveyors: Ambulatory
41. American Society of Health-System Pharmacists. ASHP guidelines Surgical Centers. 2020 Feb 21. Available at: https://www.cms.gov/
on outsourcing sterile compounding services. Am J Health-Syst Regulations-and-Guidance/Guidance/Manuals/downloads/
Pharm. 2015;72:1664-75. som107ap_l_ambulatory.pdf. Accessed June 13, 2022.
42. Institute for Safe Medication Practices (ISMP). Best Practice 9. In: 58. Institute for Safe Medication Practices (ISMP). Are you well
ISMP Targeted Medication Safety Best Practices for Hospitals. ISMP; positioned to resolve conflicts with the safety of an order?
2022. Available at: https://www.ismp.org/guidelines/best- Learning from a physician’s homicide trial and the firing of
practices-hospitals. Accessed June 13, 2022. multiple healthcare workers. ISMP Medication Safety Alert! Acute
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Alert! Acute Care. 2007;12(23):3. ISMP Targeted Medication Safety Best Practices for Hospitals. ISMP;
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(Archived). In: ISMP Targeted Medication Safety Best Practices for Library. In: ISMP Guidelines for Optimizing Safe Implementation and
Hospitals. ISMP; 2022. Available at: https://www.ismp.org/ Use of Smart Infusion Pumps. ISMP; 2020. Available at: https://
guidelines/best-practices-hospitals. Accessed June 13, 2022. www.ismp.org/guidelines/safe-implementation-and-use-smart-
pumps. Accessed June 13, 2022.
46. Institute for Safe Medication Practices (ISMP). Core Safety
Process #3 Provide profiled ADCs and monitor system overrides. 61. Siegel JD, Rhinehart E, Jackson M, Chiarello L, the Healthcare
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Hazardous Drugs—Handling in Healthcare Settings. 2019 Dec 1.
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by skin preps and ointments: rare but dangerous and preventable. pharmaceuticals used in the practice of anesthesiology. Available at:
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labeling-of-pharmaceuticals-for-use-in-anesthesiology. Accessed
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52. Institute for Safe Medication Practices (ISMP). Section 1.
Disclosure
Summit speakers were selected by ISMP, and some received a modest honorarium for their presentation.
Summit attendees were volunteers and received no compensation for their feedback. ISMP is grateful for these
volunteers and acknowledges their expertise and assistance in the development of this guideline document.
ISMP also thanks the many practitioners and industry partners that took the time to consider and provide
feedback during the public comment period.
About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted
entirely to preventing medication errors. ISMP is known and respected for its medication safety information.
For more than 25 years, it has also served as a vital force for progress. ISMP’s advocacy work alone has
resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging.
Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting
program, publishes newsletters with real-time error information read and trusted throughout the global
healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In
2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities
in the world, and ECRI and the ISMP Patient Safety Organization (PSO) is a federally certified patient safety
organization by the US Department of Health and Human Services. As an independent watchdog organization,
ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants,
newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow
@ismp_org to learn more.

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ISMP Guidelines for

Safe Medication Use

How to Use the Guideline Statements

How to Cite the Guidelines:

KEY ELEMENT I: PATIENT INFORMATION

2.3 Enter preoperative/preprocedural and postoperative/postprocedural orders for medications (including

KEY ELEMENT IV: DRUG LABELING, PACKAGING, AND NOMENCLATURE

continued on page 11 >

4.10 Immediately discard any unattended, unlabeled medication or solution.38,39

KEY ELEMENT V: DRUG STANDARDIZATION, STORAGE, AND

Access to perioperative medications is restricted and controlled.

continued on page 13 >

5.9 Prioritize the use of PROFILED ADCs in preoperative/preprocedural and postoperative/postprocedural

The complement of qualified, well-rested practitioners in the perioperative setting matches

KEY ELEMENT IX: PATIENT EDUCATION

continued on page 18 >

Redundancies that support a system of INDEPENDENT DOUBLE CHECKS or automated

10.11 Use machine-readable coding (e.g., BARCODE SCANNING, RFID) in preoperative/preprocedural

Lack of consensus/agreement on the content and sequencing of drug

Limited adoption of medication-related technology and safety resources

ASCs and ambulatory settings

continued on page 21 >

INDEPENDENT DOUBLE CHECK(S)/INDEPENDENTLY MODERATE SEDATION: A drug-induced depression

OPIOID-TOLERANT/OPIOID TOLERANCE (adult patient): SMART INFUSION PUMP(S)/SMART INFUSION PUMP

REGIONAL ANESTHESIA: Refers to peripheral nerve

National Perioperative Medication Safety Summit Participants

Racheal Adams, PharmD Franchesca Charney, RN, MS, CPHRM, CPPS,

continued on page 25 >

Eliot Grigg, MD Misti Spann, PharmD

continued on page 26 >

ISMP Fellow Contributors

About the Institute for Safe Medication Practices

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