Patient Safety Tip
of the Week
January
1, 2019
More on Automated Dispensing Cabinet (ADC) Safety
In our December 11,
2018 Patient Safety Tip of the Week “Another NMBA Accident” several
issues arose about the role of the ADC (Automated Dispensing Cabinet) in the
unfortunate accident in which a patient was inadvertently administered a fatal
dose of the NMBA (neuromuscular blocking agent), vecuronium.
In that December 11, 2018 Patient
Safety Tip of the Week “Another NMBA Accident”,
the following ADC-related issues were discussed:
1.
The
vecuronium was dispensed from the ADC via an override.
2. The warning on the ADC about vecuronium was
too vague. It said it should be for STAT orders. Instead, we feel the
warning should have requested
confirmation that “the patient is intubated/ventilated or about to be
intubated”.
3.
No
independent double check was required for ADC overrides.
4.
NMBA’s (neuromuscular
blocking agents) should not be available in floor stock or ADC’s other than in the
OR, ER, and ICU’s. And in the latter areas there are probably better ways/places
to store NMBA’s (ISMP recommends they be stored in lidded boxes or in rapid
sequence intubation kits).
5.
The ADC
search function defaulted to generic names, when the CPOE order used a brand
name (so the nurse could not find the correct ordered medication when searching
the patient’s profile).
Since that column,
another serious incident in which an ADC was a factor has been reported (CDPH 2018). A patient
was given a fatal direct IV injection of concentrated Levophed
(norepinephrine) rather than the diluted IV continuous drip infusion that had
been ordered. The Levophed had been in a concentrated
form in a vial in an ADC in the ICIU where the patient was hospitalized. It was
removed from the ADC by a licensed nurse (LN1), even though a pharmacy premixed
IV infusion of Levophed was stored in a refrigerator
across from the ADC. It is not clear whether a formal double check was required
for removal of this high alert medication from the ADC. The CDPH statement of deficiencies
says that a second licensed nurse (LN2) was “cosigner” for LN1 but never looked
at the medication and was unaware it was going to be given by IV push. LN1
noted she pushed the touch screen for each of the patient's meds and did not
read the touch screen instructions written for Levophed
to be diluted in 250 ml of D5 and given as a drip. LN1 stated she had never
given Levophed and did not research it or double
check with the co-signer about the medication administration,
In addition to
training and education on a variety of issues related to this incident, the
facility implemented several changes in processes and procedures related to the
ADC and storage and dispensing of Levophed following
the incident:
·
Process changed for new, after-hour orders for levophed, 2 RN's are required to access and sign out Levophed from automated dispensing machine.
·
Levophed purchased as
a premixed bag from pharmaceutical company and placed in ICU automated dispense
system and on all Code Carts In hospital.
·
Added to automated dispensing system an alert
for Levophed: MUST BE DILUTED IN D5 250ml. For IV
infusion Only. Not for IV push.
·
Levophed vial (concentrated)
was removed from automatic dispensing system.
·
Levophed vlal was made part of a kit which included the medication vial,
a 250 ml bag of admixture solution, mixing instructions and a label. (Items
included in the label are: Drug Name, Amount of Drug, Type and Amount of
Diluent, Concentration, Added By Date, and Expiration Date).
This kit is only used when pre-mixed bag would not be available.
So these 2 cases got us wondering about other vulnerabilities and safety
issues related to ADC’s. ADC’s, of course, have many valuable benefits. They
certainly help get medications to patients in a more timely
fashion. They also improve inventory functions, allow tracking of medications,
and improve charge capture. We’re also glad to see they’re being used to manage
certain non-medication medical supplies (Bourcier 2016).
We have advocated
for that for over 10 years (see, for example our April 21, 2009 Patient Safety
Tip of the Week “Still Futzing with Foleys?” where we suggested we treat Foley catheters
like medications and use CPOE and barcoding to improve management).
A survey of nurses
about their attitudes toward ADC’s (Rochais 2014)
found that nursing staff considered the introduction of ADC made their work
easier (level of agreement of 90%), helped to safely provide patients with care
(91%), and helped to reduce medication incidents/accidents (81%). Nursing staff
was particularly satisfied by the narcotic drugs management with the ADCs.
Nursing staff were not satisfied with the additional delays in the preparation
and administration of a medication dose and the inability to prevent a medication
from being administered when stopped on the medication administration record
(48%).
But, regarding medication safety, other than
rates of wrong-time medication errors, results have been mixed (Grissinger 2012).
ISMP (ISMP 2008) notes “ADCs can
also reduce the risk of medication errors, but only when specific safeguards are
consistently available and used.”
A significant problem with ADC’s is the override
process. Note that the override process bypasses several medication
safeguards. It often is the result of a verbal order and bypasses verification
by a pharmacist and the bedside medication verification (barcoding) system.
As early as 2005 the Pennsylvania Patient Safety Reporting
System (PA-PSRS
2005) began noting a role
of ADC’s in medication errors. Nearly 15% of all medication error reports cited
ADCs as the source of the medication, and 23% of these reports involved high-alert
medications. Many of these reports described cases in which the design and/or
use of ADCs contributed to the errors. The types of errors include wrong drug
errors, stocking/storage errors, and medications being administered to patients
with a documented allergy. They noted factors contributing to these errors:
·
Lack of pharmacy screening of medication orders
prior to availability for administration.
· Excessive use of overrides in cabinets with patient profiling, placing the patient at risk of allergic reactions, drug interactions, and other hazards.
·
Failure to recognize look-alike names in the design
of an ADC’s alphabetic pick list or storage compartments, which can lead to choosing
the wrong medication
The PA-PSRS report noted, in addition to
overrides, other types of workarounds:
·
removal of medications using the “inventory”
function to gain access to medications for patients without pharmacy screening
·
removing a larger quantity of medications than
ordered for one patient
·
removing medications for multiple patients while
the cabinet is open
The PA-PSRS report also mentions the types
of LASA (look-alike, sound-alike) errors and “picklist” errors that we
discussed in our December 11, 2018 Patient Safety Tip of the Week “Another
NMBA Accident”.
In 2008 ISMP (ISMP 2008) reported results of a survey on ADC’s. They found gaps in
using double checks when stocking ADC’s or when withdrawing medications from
ADC’s. They noted a case where an automated
dispensing cabinet on the neonatal unit had been inadvertently stocked with
heparin vials containing 10,000 units/ml. Nurses were used to drawing heparin from
10 units/mL vials from that cabinet and did not notice the difference (see our December
2007 What's New in the Patient Safety World column “1000-fold Heparin Overdoses Back in the News
Again”). ISMP notes the importance
of the interface between the pharmacy information system and ADCs so
pharmacists can profile, screen, and approve medications before they are
removed from the cabinet for administration. The override capability in ADC’s may
short-circuit that safety feature. Stocking multiple concentrations of
medications in the ADC’s can also be problematic. They also noted problems with
ADC design, ADC locations (some locations may be more vulnerable to
distractions), workflow issues, practice habits, and workarounds.
ISMP offered the
following “12 Core Processes Associated with Safe ADC Use”:
1. Provide
ideal environmental conditions for the use of ADCs
2. Ensure
ADC system security
3. Use
pharmacy-profiled ADCs
4. Identify
and include information that should appear on the ADC screen
5. Select
and maintain proper ADC inventory
6. Select
appropriate ADC configuration (e.g., lidded compartments are preferred to
matrix drawers)
7. Define
and implement safe ADC restocking processes
8. Develop
procedures to ensure the accurate withdrawal of medications from the ADC
9. Establish
strict criteria for ADC system overrides
10. Standardize
processes for transporting medications from the ADC to the patient’s bedside
11. Eliminate
the process for returning medications directly to their original ADC location
12. Provide
staff education and competency validation
ISMP has also
recently re-surveyed hospitals and is in the process of revising its Guidelines
for Safe Use of Automated Dispensing Cabinets (ISMP 2018a). Though
the latter is yet in draft format, we hope you’ll read the guidelines that are
far too numerous for today’s column. But here are a few highlights:
They have good
recommendations about using biometrics for access to ADC’s, defining user privileges,
strict management of usernames and passwords, timeframes for the ADC to time
out, audits, procedures for addressing discrepancies, optimizing and
maintaining ADC inventory, and many others.
They have excellent
recommendations regarding overrides,
including good planning for when overrides would be allowed and regular review
of override reports by an interdisciplinary group. You should implement
strategies that reduce the risk of error when an override is used:
a. Avoid the use of
multi-dose containers.
b. Limit the
quantity and number of drug concentrations available on override.
c. Use a process
where the drug and dose are checked against the patient’s allergies and weight,
if applicable, to determine if the drug and dose are appropriate.
d. Require
documentation of override rationale.
e. Consider an
independent double-check with another licensed healthcare provider when
removing organization-identified high-alert medications on override.
They recommend you
should limit overrides to the following situations:
a. When a licensed
independent practitioner controls ordering, preparation, and administration of
the medication.
b. When medications
are required in emergent circumstances and waiting for a pharmacist to review
the order could adversely impact the patient’s condition, such as the need for:
·
Antidotes, rescue, and reversal agents
·
Life-sustaining medications
·
Urgent comfort measure medications (e.g., to
manage acute pain or intractable nausea and vomiting)
In our December 11,
2018 Patient Safety Tip of the Week “Another NMBA Accident”
we discussed 2015 the Pennsylvania Patient Safety Authority advisory about
overrides of healthcare technologies (Grisinger 2015).
Over 75% of the overrides involved ADC’s.
The most common type of event involving overrides of ADCs were unauthorized medications
(e.g., obtaining a medication for a patient with no prescribed order for the patient),
followed by wrong-drug events and wrong dosage form events (e.g., selecting a sustained-release
product instead of the immediate-release form, selecting an oral formulation
instead of the injection). A majority of the
unauthorized medication events specifically stated there were no orders for the
medication, and over 30% of the unauthorized medication events involved a
high-alert medication. Many of the cases involved withdrawal of a medication from
the ADC before pharmacist verification or when the pharmacy was closed.
An analysis of
safety of nebulized medications (ISMP 2018b) found that trying to obtain a nebulizer medication via
override from an ADC was a factor linked to numerous wrong drug/strength/form
errors and wrong patient errors.. Many of the errors involved mix-ups when
selecting albuterol, and the combination product, ipratropium and albuterol. In
most of the reported events, a respiratory therapist had removed the medication
via override prior to administering the treatment. In a few instances, nurses
had obtained the medication via override and either administered it or gave it
to a respiratory therapist who was not allowed to access the ADC.
The ISMP revised
guideline draft (ISMP 2018a) provides
good lists of which medications should not be included in ADC’s (examples: medications
that require multiple dilutions or calculations, U-500 insulin vials and pens,
vials/ampules of concentrated electrolytes, and medications that have been
restricted from ADC storage based on organizational USP 800 Assessment of Risk).
They note that, if
neuromuscular blocking agents are stocked in an ADC, ADC pockets or drawers
containing neuromuscular blocking agents should include an auxiliary label to
clearly communicate that respiratory paralysis will occur and ventilation is
required (e.g., WARNING: CAUSES RESPIRATORY PARALYSIS—PATIENT MUST BE
VENTILATED). Note that, while we endorse that label, it is not enough. The
message that should appear on the ADC screen when an NMBA is selected should require confirmation that “the patient is
intubated/ventilated or about to be intubated” before access is granted.
The ISMP revised
guideline draft also discusses the need to define procedures for accurate ADC
withdrawal and transfer to the bedside. Good practice would:
·
Prohibit the removal of medications using an
inventory function.
·
Confirm accurate selection by comparing the
product to the order or the MAR.
·
Require that practitioners remove medications
from the ADC one patient at a time.
·
When medications are removed from a non-profiled
ADC, and additional safety support such as bedside barcode medication administration
is not available, configure the ADC to require users to barcode scan
medications upon removal to ensure the correct drug has been selected.
·
Label all clinician-prepared syringes of IV push
medications or solutions, unless the medication or solution is prepared at the
patient’s bedside and is immediately administered to the patient without any
break in the process.
·
Transport medications, removed from the ADC, to
the bedside in their original unit-dose or unit-of-use package. Open packages
immediately prior to use at the patient’s bedside. The only exception may be
for medications that need to be crushed, measured, or wasted.
·
Hand-carry a single patient’s medications for
one administration time directly to the patient’s bedside. Alternatively,
establish standard work to allow practitioners to sequentially remove two
patient’s medications while at the ADC provided that each patient’s medications
are bagged separately and appropriately labeled at the time of removal. (We don’t
like that “alternative”. We think that carrying medications destined for two
different patients always increases the risk of wrong patient errors).
Drake and colleagues (Drake
2016) described a
successful quality-improvement project in which CPOE was utilized to limit overrides
in the emergency department. Before November 2012, the ADCs in the emergency
department (ED) at Indiana University Health Methodist Hospital were programmed
for “total override,” allowing nurses access to all medications in the machines
independent of patient orders. At the time of CPOE implementation, ADC
inventory for each area of the ED was evaluated in order to anticipate which
medications should not be subject to override limitations. It was decided that
these products should include life-saving, ED-specific medications (e.g.,
alteplase, activated charcoal), medications used for bedside procedures (e.g.,
bupivacaine injection, topical tetracaine), comfort care medications (e.g.,
acetaminophen tablets), and bulk items (e.g., magnesium citrate oral solution,
oxymetazoline spray).
The nursing staff
leadership were concerned over pharmacist turnaround time, ED nurses were
accustomed to accessing medications from ADCs without delay. CPOE autoverification logic was implemented to allow for certain
medications to be accessible from ADCs without pharmacist verification (i.e.,
immediately upon order placement by a provider, the status of certain orders
was automatically changed to “verified” and the ordered medication could be
removed from an ADC right away). It was decided that the autoverification
list should include only medications considered to be emergently needed and
those with a wide therapeutic index and minimal monitoring requirements and
only if an ordered medication posed no threat of drug allergies or
interactions.
After
implementation of the limited override functionality, the proportion of ADC-stocked
medications removed on override was reduced to 17.5%. Fifty-five percent of the
orders entered in the ED qualified for autoverification.
The mean total verification time, including autoverified
orders, was 2.48 minutes. The mean pharmacist verification time, excluding autoverified orders, was 5.39 minutes. Two years after
implementation of the new processes, all ADCs within the ED continued to
operate on limited override. Subsequently, additional ADC’s in postoperative,
labor and delivery, and procedural areas were removed from total override.
ADC’s are very valuable
tools and are clearly here to stay. But careful attention is needed to ensure
that they don’t inadvertently contribute to serious medical errors. It’s
critical that you don’t just do perfunctory review of ADC overrides. You need
to find out how often and why such overrides are used. We hope that the
recommendations in today’s column and our December 11, 2018 Patient Safety Tip
of the Week “Another NMBA Accident”
about not only overrides but also the stocking, storage and dispensing issues,
and the critical messaging functions for drugs like NMBA’s will help you
identify vulnerabilities in your own organizations.
References:
CDPH (California
Department of Public Health). Complaint lntalke Number:
CA00424314; CDPH 8/16/18 accessed December 18, 2018
Bourcier
E, Madelaine S, Archer V, et al Implementation of automated dispensing cabinets
for management of medical devices in an intensive care unit: organisational and financial impact. Eur J Hosp Pharm 2016;
23 :86-90
https://ejhp.bmj.com/content/23/2/86
Rochais
E, Atkinson S, Guilbeault M, Bussieres
J-F. Nursing Perception of the Impact of Automated Dispensing Cabinets on
Patient Safety and Ergonomics in a Teaching Health Care Center. Journal of
Pharmacy Practice 2014; 27(2): 150-157
Grissinger
M. Safeguards for Using and designing automated dispensing cabinets. Pharmacy
& Therapeutics 2012; 37(9): 490-491, 530
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462599/
ISMP (Institute for
Safe Medication Practices). ADC Survey Shows Some Improvements, But Unnecessary
Risks Still Exist. ISMP Medication Safety Alert Acute Care Edition 2008; January
17, 2008
https://www.ismp.org/resources/adc-survey-shows-some-improvements-unnecessary-risks-still-exist
PA-PSRS (Pennsylvania
Patient Safety Reporting System). Problems Associated with Automated Dispensing
Cabinets. PA-PSRS Patient Safety Advisory 2005; 2(3): September 2005
http://patientsafety.pa.gov/ADVISORIES/documents/200509_21.pdf
ISMP (Institute for
Safe Medication Practices). Revised Guidelines for Safe Use of Automated
Dispensing Cabinets (draft). ISMP 2018; July 23, 2018
https://www.ismp.org/sites/default/files/attachments/2018-07/ADC_Guidelines_PUBLICDRAFT.pdf
Grisinger
M. Medication Errors Involving Overrides of Healthcare Technology. Pa Patient Saf Advis 2015; 12(4): 141-148
http://patientsafety.pa.gov/ADVISORIES/Pages/201512_141.aspx
ISMP (Institute for
Safe Medication Practices). Safety with Nebulized Medications Requires an
Interdisciplinary Team Approach. ISMP Medication Safety Alert Acute Care
Edition 2018; February 22, 2018
https://www.ismp.org/resources/safety-nebulized-medications-requires-interdisciplinary-team-approach
Drake E, Srinivas
P, Trujillo T. Using computerized prescriber order entry to limit overrides
from automated dispensing cabinets. American Journal of Health-System Pharmacy
2016; 73(14): 1033-1035
https://academic.oup.com/ajhp/article/73/14/1033/5101547
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