3. Purpose&Objectives
After successful completion of this course, you will be able to:
1. Discuss the purpose for designating medications as high-alert medications.
2. Define the process the ISMP uses to designate high-alert and give examples of
recommendations to improve safety with high-alert medications.
3. Discuss the list of high-alert medications and how your institution designates the
medications to be handled as high alert medications.
4. What are High-
Alert
Medications?
High-alert medications are more likely than other medications to be
associated with harm.
High-alert medications are defined as medications which have the highest
risk for causing injury when misused.These medications have narrow
therapeutic indexes or small margins of safety; that is, there is a small
difference between a therapeutic dose and a harmful dose.
To enhance patient safety, it is important that healthcare facilities review
the ISMP High-Alert Medication List routinely and compare
incident/occurrence reports to designate those medications that should be
included the healthcare institutional policy.
High-alert medications include high and low frequency medications such as
insulin, heparin, warfarin, narcotics, sedatives and chemotherapy. In fact,
researchers have reported that 2/3 of emergency admissions for adverse
medication reactions were related to warfarin, insulin, oral antiplatelet
agents and oral hypoglycemic agents.
5. What are the
Risks?
(1) Overdoses of anticoagulants or insufficient monitoring and adjustments
(according to laboratory test values) were associated with hemorrhagic
events;
(2) Overdosing or failure to adjust for drug-drug interactions of opiate
agonists was associated with somnolence and respiratory depression;
(3) Inappropriate dosing or insufficient monitoring of insulins was associated
with hypoglycemia;
(4) Poorly written Medication Orders;
(5) Confusion between different strength of the same Medication;
(6) LookAlike/SoundAlike Medications
6. What are the
Risks?
Warfarin: Warfarin is commonly involved in ADEs for a number of reasons. These reasons include
the complexity of dosing and monitoring, lack of patient adherence, numerous drug interactions,
and dietary interactions that can affect drug activity. Strategies to improve both the dosing and
monitoring of these high-alert medications have potential to reduce the associated risks of
bleeding or thromboembolic events.
Narcotics: Many patients may experience harm even with appropriate dosing of narcotics.The
most common kinds of harm include over sedation, respiratory depression, confusion, lethargy,
nausea, vomiting, and constipation. Much of this harm can be prevented with appropriate dosing
or selection of a different method of pain relief.
Insulin: Insulins are effectively used to treat diabetics and elevated blood sugars in postoperative
patients.The goal of therapy is to achieve control without causing immediate harm associated
with hypoglycemia or long-term harm associated with hyperglycemia.The pharmacology of the
drug, complexity of dosing, and variety of available products all contribute to the potential for
error and associated harm.
Sedatives: Sedatives are a necessary component of an armamentarium to treat patients in the
hospital setting. Examples of medications in this class include benzodiazepines and chloral
hydrate. Patients in hospitals may require sedation prior to procedures and during the hospital
stay. However, inappropriate use may result in over sedation, hypotension, delirium, and
lethargy, and may contribute to the risk of falling. When administered together, sedatives and
narcotics have a synergistic effect, depressing the central nervous system. An ISMP survey
identified benzodiazepines in patients over 65 (e.g., alprazolam) as high-alert.
7. Preventing
Harm
Design processes to prevent errors and harm.
Design methods to identify errors and harm when they occur. Design methods to
mitigate the harm that may result from the error.
Develop order sets, preprinted order forms, and clinical pathways or protocols to
establish a standardized approach to treating patients with similar problems, disease
states, or needs.
Minimize variability by standardizing concentrations and dose strengths to the
minimum needed to provide safe care.
Consider centralized pharmacist-or nurse-run anticoagulation, insulin management,
and pain management services.
Include reminders and information about appropriate monitoring parameters in the
order sets, protocols, and flow sheets.
Consider protocols for vulnerable populations such as elderly, pediatric, and obese
patients.
AdoptTALL man lettering for pharmacy produced labels to differentiate drug names
with potential for mix-up.
Standardizing orders: standardizing and simplifying core medication processes in
known high-risk areas.
Medication Reconciliation
Reducing the number of drug concentrations
Utilizing “just culture” methods when evaluating errors: Creating safety cultures that
minimize blame and maximize communication.
8. Identify Errors
Include reminders and information about appropriate
monitoring parameters in the order sets, protocols, and flow
sheets.
Ensure that critical lab information is available to those who
need the information and can take action.
Implement independent double-checks where appropriate.
Instruct patients on symptoms to monitor for side effects and
when to contact a health care provider for assistance.
Develop protocols allowing for the administration of reversal
agents without having to contact the physician.
Ensure that antidotes and reversal agents are readily available.
Have rescue protocols in place for staff to follow.
10. Name
Confusion
Celebrex or Celexa?
Losec or Lasix?
Seroquel or Seroquel XR?
Medication incidents involving Look-Alike/Sound-Alike drug names can
cause serious patient harm. It is often difficult to detect the error, as the
dispensed medication is presumed to have been the one that is prescribed
for the patient. In a community pharmacy, these errors can occur at any point
in the medication use system, including prescribing, order entry, dispensing,
administration and/or monitoring. Incident reporting can be used to gain a
deeper understanding of contributing factors or potential causes leading to
medication incidents involving look-alike/sound-alike drug names.
11. Individual
Factors
Individual factors take into account human capabilities, limitations, and
characteristics, such as confirmation bias, illegible handwriting,
knowledge deficit, etc.
INCIDENT EXAMPLE POSSIBLE
CONTRIBUTING
FACTORS
COMMENTARY
A physician wrote a
prescription for
Hydrocortisone 1% in
Mycostatin®;
however, Hydrocortisone 1% in
Miconazole (Monistat®) was
filled.
The pharmacy staff member
thought
Mycostatin® and Miconazole
were
the same thing.
• Knowledge deficit
• Confirmation bias
• Illegible handwriting on
the prescription
• Lack of independent
double checks
In order to clearly indicate medication, dosage, and
instructions on prescriptions, physicians should consider
using standardized pre-printed order forms.Warning
flags should be incorporated into the pharmacy
computer systems to alert for potential mix-up during
drug selections. Independent double checks should be
performed throughout the entire pharmacy workflow.
This may include a verification with the patient or the
patient’s agent regarding the indication of the
medication during drop-off or pick-up of prescription.
To avoid incidents related to confirmation bias,
indications for each medication should be included on
the prescription. It is recommended to highlight
information related to look-alike/sound-alike drug
names as part of pharmacy staff training and
communications.
12. Environmental
Factors
Environmental factors refer to issues in the work environment or within
the workflow process, such as drug storage, environmental
distractions, drug shortage, etc.
INCIDENT EXAMPLE POSSIBLE
CONTRIBUTING
FACTORS
COMMENTARY
Due to the shortage of Apo®-Amilzide,
Novamilor was filled for the patient.When
Apo®-Amilzide became available, the
pharmacy staff member planned to switch
back to it. However, theApo®-Amiloride
was chosen instead of Apo®-Amilzide.
Apo®-Amilzide was a combination drug
including amiloride and
hydrochlorothiazide. Patient noticed the
yellow color tablets when picking up the
prescription and questioned the
pharmacist.The patient’s profile was
checked and the error was noticed.
Drug shortage
• Proximity of storage of
look-alike/sound-alike drug
pairs
• Lack of independent
double
checks
The look-alike/sound-alike drug pairs
should be stored in separate locations or in
non-alphabetical order on shelves.
Independent double checks should be
performed throughout the entire pharmacy
workflow. This may include a verification of
patient’s prior medication use in the patient
profile prior to dispensing
13. Technological
Factors
Technological factors are related to the use of pharmacy computer
systems, such as copying prescriptions and scanning barcodes.
INCIDENT EXAMPLE POSSIBLE
CONTRIBUTING
FACTORS
COMMENTARY
A patient tookTri-Cyclen® LO
before and received a new
prescription from the doctor for
Tri-Cyclen®. The staff member
copied from previous prescription
on patient’s profile and filled asTri-
Cyclen® LO.The patient noticed
the medication package was the
same as before and was
anticipating a change. The patient
returned to the Nursing station
before she took the pills.
• Confirmation bias
• Copying previous
prescriptions
• Lack of independent
double checks
The copy functionality available in some EMR
software systems to enhance workflow. In
order to prevent confirmation bias, policies
may be considered within the pharmacy to
limit the process of copying from previous
prescriptions (where applicable).The inputted
prescription information should be verified
against the original prescriber-generated
prescription order.
When providing medication counselling,
pharmacists should encourage
patients/caregivers to actively participate in
the conversation (e.g. confirm the appearance
of the medication, discuss the use, and verify
indication and appropriate technique for
administration of the medication, etc.)
14. Unique Factors
Unique factors are special characteristics pertaining to look-alike/ sound-
alike drug pairs themselves, such as similar dose, similar indication, same
ingredients available in multiple formulations, etc.
INCIDENT EXAMPLE POSSIBLE
CONTRIBUTING
FACTORS
COMMENTARY
A patient was prescribed Carbamazepine
CR 200mg; butCarbamazepine 200mg
was dispensed.
•The look-alike/sound-
alike drug pairs has similar
or same therapeutic
indications
• The look-alike/sound-
alike drug pair is available
in similar or same strength
•The same active
ingredient is available in
multiple formulations
• Lack of independent
double checks
Warning flags should be incorporated into
the pharmacy computer systems to alert for
potential mix-up during drug selection.
Auxiliary alerts should be placed on
medication storage bins or shelves, where
look-alike/sound-alike drugs are potentially
stored.
Independent double checks should be
performed throughout the entire
medication management workflow.
The prescription was written for
Hydrocortisone 1% ointment; however,
Hydrocortisone 1% cream was
dispensed.