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Patient Safety Tip
of the Week
June 9, 2020 Perioperative Medication Safety
· Lack
of a second set of eyes
Often, one individual (the anesthetist) is responsible for ordering, preparing,
administering, and monitoring a medication in the OR. This bypasses the
opportunities we typically see elsewhere where a second or third individual (eg. nurse, pharmacist) can spot an error and intervene
before the error reaches the patient.
· Lack
of many of the medication safety tools we use outside the OR (eg. bedside medication verification with barcoding)
· Lack
of IT safety tools
Many OR information systems are still not interactive with the main hospital
electronic medical record (EMR) and computerized physician order entry (CPOE) systems
so the opportunity to utilize clinical decision support (CDS) tools may not be
available in the OR
· The
final line of defense, the patient himself or herself, often cannot participate
in safety activities because he/she is under the influence of anesthesia or
other medications that cloud cognition
· Handoffs
(eg. pre-anesthesia to OR, OR to PACU, PACU to ICU,
etc.) are opportunities for communication failures
· Patients
undergoing surgery or procedures often have complicated medical problems and
many of their previous medications (or meals) may have been held prior to
surgery
· The
OR is a complex environment, where distractions and interruptions are common
· Multitasking
is common in the OR and other perioperative settings
· The
OR functions as a team and sometimes communications and coordination within the
team are suboptimal
· Supplies
may not be immediately available
· Many
orders in the OR are verbal orders, which are prone to miscommunication and
incompleteness
· Dare
we mention hierarchy, egos and lack of a culture of safety?
Probably
the most telling story about perioperative medication safety was a study from
the Massachusetts General Hospital (Nanji 2015)
that we discussed in our November 3,
2015 Patient Safety Tip of the Week “Medication Errors in the OR
- Part 2”.
In fact, one in every 20 perioperative medication administrations resulted in a
medication error or adverse drug event. The overall rate of 5.3% is pretty close to
the rates we typically see on inpatient units. And almost half of all surgery cases had at least one medication error or adverse
drug event.
A recent AORN review (Spruce 2020) of
perioperative medication safety identified several other factors contributing
to medication errors in the perioperative environment:
· a
lack of standardized documentation systems which may affect medication order
transcription
· health
care personnel fatigue related to work and call schedules
· time-sensitive
medication administration to address a patient’s condition
· the
removal of medication from the original manufacturer’s packaging for aseptic
delivery to the sterile field
· multiple
individuals may handle medications on sterile fields before administration
· a
lack of standardized medication-labeling practices
· a
lack of oversight by a licensed pharmacist
· distractions
during medication preparation and administration
· some orders may be handwritten rather than
entered via CPOE, handwritten orders being more prone errors such as use of
inappropriate abbreviations
The
Spruce review further notes that pediatric patients undergoing surgery are at
an increased risk for medication errors because of weight-based dosing
calculations and dilutions.
Among
the recommendations in the Spruce review:
·
Health care facility leaders should form an
interdisciplinary team (ie, a medication safety
committee) to develop, provide implementation oversight of, and evaluate the
perioperative medication management plan.
·
Perioperative leaders should work with pharmacy
supply chain staff members to procure medications in single-use vials and
prefilled syringes when possible.
·
Perioperative personnel may find it helpful to have
the medications provided for them in commonly requested amounts and volumes and
with limited variations in medication strengths and concentrations.
·
Medications stored in specialty or emergency carts
should be organized with safety considerations in mind.
·
When creating storage locations for emergency
medications, perioperative nurses should work with pharmacy staff members to
ensure that high-alert medications are separated from each other using bins and containers, all
medications are labeled and not stored alphabetically, and generic and brand
names are indicated with tall man lettering
One of the biggest vulnerabilities to serious
medication errors in the OR is related to maintenance of the sterile field. Medications transferred to the sterile
field are sometimes drawn from unlabeled containers or are in syringes that are
unlabeled. In addition, the presence of multiple syringes in the sterile field
may lead to syringe “swapping”
errors. A recent review of incorrect
administration of neuromuscular blocking agents (NMBA’s) during spinal or
epidural anesthesia (Patel 2020) found syringe swap was the primary cause
for the majority of errors. Unlabeled syringes were one factor in accidental spinal
injections discussed in our July 9, 2019 Patient Safety Tip of the Week “Spinal
Injection of Tranexamic Acid”.
The Spruce
review has good recommendations to avoid medication errors related to the
sterile field:
·
obtain and prepare one medication for one patient at
a time
·
transfer only one medication at a time to the
sterile field
·
verbally verify each medication with the scrub
person and include the medication name, strength, dosage, and expiration date
·
transfer medication to the sterile field using
aseptic technique
·
use sterile transfer devices or syringes to transfer
medications from vials to the sterile field rather than removing rubber
stoppers unless the stopper is designed to be removed (eg,
has a removable metal band)
·
collaborate with the scrub person to ensure all
containers and syringes on the sterile field that contain medications, solutions,
chemicals, and reagents are labeled immediately after transfer to the sterile
field with the medication name, strength, dilution (and diluent, if used), date,
and time the medication expires, if less than 24 hours
·
ensure labels only include approved abbreviations
and dose expressions
·
encourage use of tall man lettering for container labels when medications have
look-alike names
The
Spruce review also discusses precautions that must be taken if any medications
must be compounded or multiple medications mixed.
Regarding
handoffs, medication
reconciliation needs to take place
at all transitions of care. That includes transitions like transfer
from the pre-op area to the OR, from the OR to the PACU, from the PACU to the
ICU or med/surg unit. It’s especially important to pay
attention to any IV lines that may be connected to sources of medications. A
good checklist for such transitions of care would contain an item about
checking those IV lines. Note that transitions of care apply not only to
transfers of the patient from one location to another. In fact, the staff may
change in the OR itself (for example, nursing staff or anesthesiology staff may
occasionally change in cases of long surgical duration). Those transitions are
also vulnerable periods for medication errors as well as other errors. And don’t forget that the medication reconciliation must extend
beyond just the last transition of care. For example, many medications are
withheld prior to anticipated surgery and need to be restarted after completion
of the surgery and PACU recovery period.
Just
as elsewhere in the healthcare system, look-alike sound-alike (LASA) issues may lead to medication errors in the OR. Given the stresses, time
pressures, distractions and interruptions commonly occurring in the OR setting,
it is not surprising that someone may grab an incorrect vial that has an
appearance similar to the intended one. Similarity
of ampules of tranexamic acid and local anesthetic agents were a factor in
accidental spinal injections discussed in our July 9, 2019 Patient Safety Tip
of the Week “Spinal Injection of
Tranexamic Acid”.
It’s not surprising
that, in the heat of the moment, someone might grab the wrong medication from
an anesthesia cart or an automated dispensing cabinet (ADC). See our January 1,
2019 “More
on Automated Dispensing Cabinet (ADC) Safety” and other columns on ADC issues. It’s critical that high alert medications, in particular, be
appropriately identifiable and appropriately segregated to prevent such
inadvertent occurrences.
.
Irrigation fluids have been
involved in perioperative medication errors. In some cases, they may have been
in unlabeled basins on the sterile field. In others, the may have been in bags intended for
irrigation of certain sites (eg. bladder irrigation)
and were instead connected to IV lines.
Another recent review of
perioperative medication safety (Redman 2020) cited the work of Wahr
et al. (Wahr
2017)
that we discussed in our June 4, 2019 Patient
Safety Tip of the Week “Medication
Errors in the OR – Part 3”. Wahr et al. did a literature review and found 138 unique
recommendations for OR medication safety, then used a modified Delphi process
to whittle the list down to 35 specific recommendations. We refer you to Table
4 in the Wahr review for the full list of the 35
recommendations. Redman highlighted several of these:
· labeling
medications with the name, date, and concentration
· avoiding
using abbreviations on medication labels
· discarding
unlabeled syringes
· using
prefilled syringes whenever possible
· compounding
and diluting medications in a pharmacy
· double-checking
provider-prepared high-risk medications, preferably with a second person
· verifying
high-risk and weight-based medication dosages with a second person
· using
aseptic technique when capping syringes or injecting medications
· reading
and verifying all medication labels (eg, on vials, on
syringes) before administration
· using
standardized smart pumps for all infusions
· passing one medication to the sterile field at
a time
· segregating
noninjectable solutions (eg, irrigation fluids)
· reviewing
administered medications during patient hand overs
· verifying
verbal medication orders (eg, repeating exact information,
announcing when administration is complete)
·
discarding all medication containers at the
completion of the procedure unless they are connected to the patient.
Redman stresses the importance of proper labeling.
She cites an interesting simulation study done by Estock
and colleagues (Estock 2018). In the latter study,
anesthesia trainee participants were randomly assigned to either redesigned
labels or the current label condition. In the simulation, the surgeon asked the
participant to administer hetastarch to the simulated
patient because of hemodynamic instability. The fluid drawer of the anesthesia
cart contained three 500-ml intravenous bags of hetastarch
and one 500-ml intravenous bag of lidocaine. The percentage of participants who
correctly selected hetastarch from the cart was
significantly higher for the redesigned labels than the current labels (63%
versus 40%; odds ratio, 2.6). They concluded
that using opaque, white 2-sided medication labels on IV bags with white text
on a dark background was effective.
Monitoring is one of the most important aspects of
medication safety in any venue. Patients in the OR and PACU often have
monitoring that is as good or better than that done on a typical ICU patient.
But monitoring is complicated by the myriad of things that can happen in the
OR. For example, the occurrence of tachycardia in a patient in the OR could be a
sign of an allergic medication reaction or other adverse medication effect. But
it could also be due to blood loss, arousal from anesthesia, or rare conditions
like malignant hyperthermia, latex allergy or LAST (local anesthetic
systemic toxicity) as discussed below. Moreover, the person charged with doing
most of the monitoring – the anesthetist – is often multitasking and may be
distracted from key changes in monitored parameters.
We mentioned that one
problem commonly encountered is that certain supplies or medications may not be
readily available in the OR, leading to harried attempts to procure that
medication. But the opposite problem can also occur. That is, the inappropriate
presence of an unnecessary medication can lead to accidental use of that
medication. Our columns on the “ophthalmology blue dye accidents” (see our columns
from May 20, 2014 “Ophthalmology: Blue Dye Mixup” and
September 2014 “Another Blue Dye Eye Mixup”)
discussed cases where methylene blue dye was erroneously used in eye
surgery instead of trypan blue. There
is actually little reason to keep methylene blue in
most OR setups since it is used only in a few select instances. Similarly, the tranexamic
acid incidents (see our July 9, 2019 Patient Safety Tip of the Week “Spinal
Injection of Tranexamic Acid”) might have been avoided because tranexamic
acid is only used for a few procedures, raising the question why it would even
be included in most OR setups.
LAST (local
anesthetic systemic toxicity) is a syndrome that has only relatively recently
gained increased recognition, which may be life-threatening (Weinberg 2010, Weinberg 2020, El-Boghdadly 2018). CNS manifestations are most common, with
seizures being the most common manifestation. However, early manifestations
have been quite diverse. Perioral paresthesia, confusion, audio–visual
disturbances, dysgeusia, agitation, or reduced level of consciousness, and
cardiovascular manifestations may include dysrhythmias, conduction deficits,
hypotension, and eventually cardiac arrest. Note that the cardiovascular
manifestations often occur while the patient is under general anesthesia or
heavy sedation where CNS toxicity is difficult to ascertain. We refer you to
the articles above for discussion of treatment, which focuses on airway
management, seizure suppression, circulatory support, and the role of infusion
of lipid emulsion.
Finally, though it’s
not technically “medication” safety, latex allergy is a safety issue in
the OR and perioperative setting that certainly comes into the differential
diagnosis of medication-related issues. In our July 6, 2020 Patient Safety Tip
of the Week “Book
Reviews: Pronovost and Gawande” we described an excerpt from Peter
Pronovost’s book “Safe Patients, Smart Hospitals: How One Doctor's Checklist
Can Help Us Change Health Care from the Inside Out” in which he describes a
harrowing experience where he, as the anesthesiologist, correctly suspected a
deteriorating patient had a potentially life-threatening latex allergy during
surgery. He implored the surgeon in every way possible to change his gloves to
non-latex ones and the surgeon refused until Pronovost put out a page to the
hospital administration!
In our August 16, 2011 Patient Safety Tip of
the Week “Crisis
Checklists for the OR” we discussed an article by Ziewacz and colleagues (Ziewacz 2011) about having ready
access to checklists for managing less common crises in the OR, such as
malignant hyperthermia. We’d suggest you consider
adding checklists for LAST and latex allergies to your list of crisis
checklists for the OR.
We hope you’ll go back to our series of
medication errors in the OR (March 24,
2009 “Medication Errors in the OR”, November 3, 2015 “Medication
Errors in the OR - Part 2” and
June 4, 2019 “Medication Errors in the OR
– Part 3”)
which had very good recommendations from ISMP (Institute for Safe Medication Practices)
(ISMP 2015), PPSA (Pennsylvania Patient Safety
Authority) (Cierniak 2018), AORN (Association of periOperative Registered Nurses) (Novak 2015, Litman 2018, Sones 2019, Boytim 2018),
and APSF (Anesthesia Patient Safety Foundation) (APSF
2012), among others.
And it goes without saying that every attempt
should be made to extend our medication safety tools to the OR. That includes
integration of the OR information system with the facility-wide EMR and CPOE,
use of barcoding for medication verification, use of standardized doses and
pre-filled syringes, use of smart pumps, having a clinical pharmacist as part
of the team, and others.
Some
of our prior columns on medication errors in the OR:
March
24, 2009 “Medication Errors in the OR”
May
20, 2014 “Ophthalmology: Blue Dye Mixup”
September
2014 “Another Blue Dye Eye Mixup”
November
3, 2015 “Medication
Errors in the OR - Part 2”
June
4, 2019 “Medication Errors in the OR
– Part 3”
July 9, 2019 “Spinal Injection of
Tranexamic Acid”
References:
Nanji KC, Patel A,
Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and
Adverse Drug Events. Anesthesiology 2015; October 2015 Newly Published on 10
2015
http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2466532
Spruce L. Back to Basics: Medication Safety.
AORN Journal 2020; 111(1): 103-112
https://aornjournal.onlinelibrary.wiley.com/doi/full/10.1002/aorn.12891
Patel S. Erroneous neuraxial administration
of neuromuscular blocking drugs, European Journal of Anaesthesiology
2020; Published Ahead of Print May 05, 2020
Redman DD, Perioperative Medication Safety: A
Continuing Challenge. AORN Journal 2020; 111(1): 116-120
https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.12911
Wahr A, Abernathy JH,
Lazarra EH. Medication safety in the operating room:
literature and expert-based recommendations. British Journal of Anaesthesia 2017; 118 (1): 32-43
https://bjanaesthesia.org/article/S0007-0912(17)30113-7/fulltext
Estock JL, Murray
AW, Mizah MT, et al. Label design affects medication safety
in an operating room crisis: a controlled simulation study. J Patient Saf. 2018;14(2): 101-106
Weinberg GL. Treatment of local anesthetic
systemic toxicity (LAST). Reg Anesth Pain Med 2010; 35:
188-193
https://www.mcgill.ca/anesthesia/files/anesthesia/wk_4b_last_2010.pdf
Weinberg G, Rupnik
B, Aggarwal N, et al. Local Anesthetic Systemic Toxicity (LAST) Revisited: A
Paradigm in Evolution. APSF (Anesthesia Patient Safety Foundation) Newsletter
2020; 35(1): 1, 5-7
El-Boghdadly K, Pawa A, Chin, KJ. Local anesthetic systemic toxicity:
current perspectives. Local and Regional Anesthesia 2018; 11: 35-44.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6087022/pdf/lra-11-035.pdf
Ziewacz JE, Arriaga
AF, Bader AM, Berry WR, et al. Crisis Checklists for the Operating Room:
Development and Pilot Testing. J Am Coll Surg 2011; 213(2): 212-219
http://www.journalacs.org/article/S1072-7515%2811%2900343-7/abstract
ISMP (Institute for Safe Medication
Practices). Key vulnerabilities in the surgical environment: Container mix-ups
and syringe swaps. ISMP Medication Safety Alert! Acute Care Edition 2015;
November 5, 2015
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=123
Cierniak KH, Gaunt
MJ, Grissinger M. Perioperative Medication Errors:
Uncovering Risk from Behind the Drapes. Pa Patient Saf
Advis 2018; 15(4).
http://patientsafety.pa.gov/ADVISORIES/Pages/201812_Perioperative.aspx
Novak R. Best Practices in Drug Safety.
Expert advice on proper medication storage, security
and labeling. Outpatient Surgery 2015; October 2015
Litman R. Tools to
Improve Medication Safety. To eliminate administration mistakes, you have to eliminate the human factor. Outpatient Surgery 2018;
July 2018
Sones S. Your Prescription for Medication
Safety. Our pharmacy consultant dispenses indispensable advice. Outpatient
Surgery 2019; XX No. 4; April 2019
Boytim J, Ulrich B.
Factors contributing to perioperative medication errors: A systematic
literature review. AORN J 2018; 107(1): 91-107
https://aornjournal.onlinelibrary.wiley.com/doi/full/10.1002/aorn.12005
APSF (Anesthesia Patient Safety Foundation).
Medication Safety in the Operating Room: Time for a New Paradigm. January 2012
http://apsf.org/resources/med-safety/
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