Guidelines for Medication Error Prevention - Pharmacy Practice News

Guidelines for
Medication Error Prevention
INSTITUTE FOR SAFE MEDICATION PRACTICES
Huntingdon Valley, Pennsylvania
Medication error prevention is an essential
requirement for pharmaceutical care and
must be a core mission of every pharmacy.
For medication error prevention to be
effective, it must become a priority. The
first priority for successful error reduction is establishing
a multidisciplinary medication-use improvement team
and providing this team with reasonable time and
resources to assess medication safety and to implement
system-level changes that make it difficult or impossible
for practitioners to make mistakes that reach the patient.
This multidisciplinary team should accept ownership of
the medication-use process and embrace the opportunity
to improve medication safety.
The goals of the team should include the following:
• Promotion of a nonpunitive approach to reducing
medication errors
• Increased detection and reporting of medication
errors and potentially hazardous drug-use situations
• Exploration and understanding of the root causes of
medication errors
• Education of practitioners about the system-based
causes of errors and their prevention
• Responsiveness to potentially hazardous situations
before errors occur
• Recommendations to facilitate organization-wide,
system-based changes to prevent medication errors
• Learning from errors occurring in other organizations
through the ISMP Medication Safety Alert! and other
published accounts of medication errors, and taking
proactive measures to prevent similar errors.
PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006 9

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature
Medication Problem Recommendation(s) Technology
Adult and pediatric hepatitis B
vaccines (Merck)
The packaging of the adult and pediatric strengths of Merck’s hepatitis B
vaccines look alike, and the labels do not provide sufficient visual
differentiation, despite different border colors. The resemblance between
the products has led to dispensing errors.
Separate the adult and pediatric strengths in all areas where these
products are stocked.
Consider affixing auxiliary labels to better distinguish the products.
2, 4
ANUSOL (ointments and topical
starch suppositories) product line
ANUSOL (Pfizer) products, used for anorectal symptoms, are now called TUCKS.
Tucks has been a registered trademark associated with topical witch hazel
products (pads, topical gel) for decades. Using this trademark name is likely
to cause confusion, especially in postpartum settings and outpatient settings
where both product lines are commonly used.
Labeling on Tucks suppository products also is inadequate, with only half of the
6 suppositories in a group labeled with the product name.
Apply auxiliary labels to clearly note the drug name and route of
administration.
Include similar warnings on medication administration records (MARs).
Alert patients to the differences between various Tucks products.
1, 2, 5
Bag and volume do not correlate
Incorrect information may be communicated if the total volume of drug and
diluent differs from that stated on the manufacturer’s label.
An infusion of ACTIVASE (alteplase, Genentech), 30 mg/30 mL, was prepared
in an empty 100-mL I.V. container for a stroke patient. The pharmacy label
stated “30 mg/30 mL, to be infused over 1 hour,” but the nurse who
administered the drug saw “100 mL” printed by the manufacturer of the
plastic container on the top and assumed that the total volume in the bag
was 100 mL. The pump therefore was set at 100 mL/h instead of 30 mL/h and
the drug was infused in about 20 min. Fortunately, the patient was not harmed.
Cover the portion of the manufacturer’s label that indicates the volume
of the container for infusions if the preparation differs significantly from
the manufacturer’s label.
Revise procedures to more clearly state the total volume added to the
bag to reduce the potential for confusion.
Be sure that all staff involved in administering high-alert drugs (such as
Activase) are familiar with applicable drug dosing and administration
protocols.
2, 3
Confusion between DAPTOMYCIN
and DACTINOMYCIN
Intending to process an order for DAPTOMYCIN (Cubicin, Cubist Pharmaceuticals),
a pharmacist typed “DA” into the system, made a selection from a computer
system pick list, and generated an I.V. label. She prepared daptomycin, but
the computer system entered into the profile and printed a label for
DACTINOMYCIN (Cosmegen, Ovation). The correct drug was administered, but
in subsequent order processing, the wrong drug would have been dispensed
because of the initial incorrect computer entry.
Ensure daily pharmacist review of antibiotic usage and double checking
against the original order.
Include both generic and brand names in computer systems if possible.
Consider use of tall man letters to enhance recognition (DAPtomycin
and DACTINOmycin).
Place name-alert warnings on storage bins and in any computerized
order entry system.
Always verify the patient diagnosis before dispensing these products.
1, 5
COUMADIN (warfarin sodium,
Bristol-Myers Squibb) and
CARDURA (doxazosin, Pfizer)
A handwritten order for CARDURA 1 mg HS was misinterpreted and dispensed
as COUMADIN for a patient in a long-term care facility. The patient received
20 doses of Coumadin before the error was discovered during a hospitalization
for uncontrolled hypertension.
Both drugs are available in 1, 2, and 4 mg tablets, and are generally
administered once daily.
The names look similar when poorly handwritten, particularly since both
Cardura and Coumadin begin with “C.”
Encourage prescribers to include the medication’s purpose on all
prescriptions.
Verify a medication’s purpose before dispensing or administering
medications, especially a high-alert medication such as warfarin.
1, 5
DEPO-SUBQ PROVERA 104
(medroxyprogesterone acetate
injectable suspension, Pfizer)
DEPO-SUBQ PROVERA 104 is a new formulation of the existing DEPO-PROVERA
(medroxyprogesterone acetate suspension) product. It is intended to be given
subcutaneously in a dose of 104 mg every 3 months. However, part of the drug
name could be left off or misaligned when prescriptions are written, leading to
confusion with Depo-Provera and potential administration by the wrong route.
Carefully review any Depo-Provera prescription to assure the correct
formulation, route of administration, indication for use, and dosage
frequency.
1, 5
MAALOX (aluminum hydroxidemagnesium
hydroxide-simethicone,
Novartis Consumer)
A new formulation of MAALOX known as Maalox Total Stomach Relief looks
identical to regular Maalox but contains bismuth subsalicylate.
All the products are packaged in white plastic containers that are the same size
and shape; “Maalox” is highlighted on the front label panel of both products,
and a banner on each proclaims, “Great new look. Same great Maalox.”
Warnings are listed on the back label panel, but it is easy to overlook
noteworthy side effects (eg, black stools and/or tongue) and warnings
related to use by children or teens with flu symptoms, patients receiving
oral anticoagulants, and patients allergic to aspirin.
Alert practitioners about brand-name extensions of Maalox, especially
since hospitals will need to purchase the products in look-alike, bulk
bottles because Novartis has discontinued unit-dose containers.
Patients also should be warned about brand-name extensions and told
to check the active ingredients in these products before they purchase
them, or to ask their community pharmacist for help.
1, 5
NOVOLOG MIX 70/30 (70% insulin
aspart protamine suspension, 30%
insulin aspart injection [rDNA origin],
Novo Nordisk), NOVOLOG (insulin
aspart [rDNA origin] injection,
Novo Nordisk), and NOVOLIN 70/30
(70% NPH, human insulin isophane
suspension, 30% regular, human
insulin, Novo Nordisk)
Product selection errors have been reported with mix-ups between NOVOLOG
MIX 70/30 and NOVOLOG.
To help prevent mix-ups, Novo Nordisk implemented new packaging for
NOVOLOG MIX 70/30. However, the most frequently reported problem with
Novo Nordisk insulin has not been addressed: name confusion between
NOVOLOG MIX 70/30 and NOVOLIN 70/30.
To prevent errors, consider limiting the insulin analog 70/30 mixtures
on the formulary to a single product.
If both Novo Nordisk 70/30 products must be on the formulary, place
reminders about confusion on storage locations.
Accentuate the differences in the products’ names by using tall man
letters (eg, NovoLIN, NovoLOG MIX).
1, 2, 4, 5
OMACOR (omega-3-acid ethyl esters,
Reliant) and AMICAR (aminocaproic
acid, Xanodyne Pharmaceuticals)
OMACOR is a new drug that looks and sounds nearly identical to AMICAR
when handwritten or pronounced.
In one report, a telephone order for Omacor was misheard as Amicar and
dispensed to a patient. Fortunately, the patient read the drug information sheet,
and called the pharmacy to let the pharmacist know he was expecting a drug
that reduced his triglycerides level.
If both medications are available in your inventory, set an alert in the
computerized order entry system to match the drug’s indication to the
patient’s diagnosis before dispensing either of these drugs.
1, 5
10 PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006

Table 1. Safety Issues Related to Labeling, Packaging, and Nomenclature (continued)
Medication Problem Recommendation(s) Technology
Organ storage solution resembles
I.V. bag
A pharmacist received what looked like a plastic liter bag of I.V. solution with
other products returned for credit. On further inspection, the pharmacist realized
the bag actually contained cold storage solution (VIASPAN, NPBI International
BV) used for hypothermic flushing and storage of organs during procurement.
The solution likely would be fatal if given intravenously.
Safeguard your processes for stocking, storing, and handling organ
storage solution.
2
PHENYTOIN (Baxter) and
PHENOBARBITAL vials (Baxter)
Baxter changed the color of the phenytoin label from dark orange to olive
green to differentiate their heparin (5,000 units/mL, 1 mL fill in 2 mL vial) and
phenytoin (100 mg/2 mL vial). However, this created a new look-alike situation
between PHENYTOIN and PHENOBARBITAL (130 mg/mL, 1 mL fill in 2 mL vial).
Phenytoin and phenobarbital may be used in the same patient population for
the same indication, status epilepticus.
Until a third label change takes place, warn staff about this risk.
Separate look-alike and sound-alike products.
Affix warning labels to automated dispensing cabinet cells and
place the vials in special plastic bags designed to alert staff to
look-alike medications.
2, 4
SALAGEN (pilocarpine; MGI Pharma)
and SELEGILINE (various)
A home health nurse received a telephone order from a dentist for an elderly
patient with dry mouth. He prescribed SALAGEN 5 mg, but the nurse misheard
the order and called the pharmacy to request SELEGILINE 5 mg. About 2 weeks
later, another pharmacist was processing a prescription for a fentanyl patch for
the same patient when the pharmacy computer system signaled an alert about a
drug interaction between fentanyl and selegiline, and the error was recognized.
Both products are available in 5 mg tablets, although selegiline is also available in
5 mg capsule as ELDEPRYL (Somerset).
Prescriptions for either of these medications should list both the brand
and generic names and include the indication for use with the medication.
Patients should be alerted to the possibility of confusion between these
products.
1, 5
TETANUS TOXOID (Sanofi Pasteur)
and TUBERCULIN PURIFIED PROTEIN
DERIVATIVE (PPD, Sanofi Pasteur)
A nurse came to the pharmacy to pick up a vial of PPD for the employee health
clinic. The technician had accidentally retrieved a 5 mL vial of tetanus and
diphtheria vaccine (Td). The nurse did not notice the mistake and administered
PPD tests using the wrong drug to 8 of her co-workers. All developed skin
reactions and some employees had chest X-rays, but none was started on
prophylactic medications. The nurse who administered the tests discovered the
error while investigating the apparent “cluster” of positive readings.
Purchase these products from different manufacturers whenever possible.
Remove tetanus toxoid and PPD from unit stock if feasible, and dispense
from the pharmacy.
Affix warning stickers on storage bins and outer cartons if both products
are available.
2, 4
TOPROL-XL (metoprolol succinate,
AstraZeneca) and TOPAMAX
(topiramate, Ortho-McNeil)
Several mix-ups have occurred between the anticonvulsant TOPAMAX and the
β-blocker TOPROL-XL, resulting in these drugs being dispensed in error.
These products also might be stored near each other if medications are stocked
alphabetically by brand name.
The imprint of the Topamax 25 mg tablet, which lists “TOP” on one side and
“25” on the other, can facilitate a mix-up with Toprol-XL.
Separate the storage of these products.
Use both brand and generic names to provide redundancy.
1, 2, 4, 5
Key
1) Computerized Prescriber Order Entry (CPOE)—A fully
integrated CPOE system that includes the capability to build
medication safety alerts (eg, look-alike names) and clinical decisionmaking
rules. The system also should directly interface with the
laboratory system and pharmacy, list drug-drug and drug-disease
interactions, and offer clinical order screening capability.
2) Bar code–enabled point-of-care (BPOC) systems—Systems
that are designed to prevent medication errors at the point of
medication administration. These systems verify and record all
medications administered to the patient through the use of a bar
code scanner that matches the medication to the patient, by
scanning a bar code on the medication as well as a bar code
on a patient’s wristband.
3) “Smart” infusion pumps—Infusion systems that allow users
to enter various drug infusion protocols into a drug library with
predefined dose limits. If a dose is programmed outside of
established limits or clinical parameters, the pumps halt or
provide an alarm, informing the clinician that the dose is outside
the recommended range. Some pumps have the capability to
integrate patient monitoring and other patient parameters, such
as age or clinical condition.
4) Automated dispensing cabinets—A robust point-of-use
dispensing system. These cabinets should be integrated with
healthcare facilities’ information systems and directly interface
with the pharmacy system. In addition, these systems must
include the ability to use bar coding technology for the
restocking process to prevent medication errors.
5) Robust pharmacy order entry system—A pharmacy order
entry system that is fully interfaced with a CPOE system. The
pharmacy system must include the capability to produce
medication safety alerts as well as directly interface with a
healthcare facility’s information systems, such as the laboratory
system. In addition, this system must be used to generate a
computerized medication administration record (MAR) for use
by the nursing staff when they administer medications.
Effective results depend on understanding the
complex medication-use process as a whole through
varied perspectives and disciplines.
The Institute for Safe Medication Practices (ISMP)
is a nonprofit organization that works closely with
healthcare practitioners and institutions, regulatory
agencies, professional organizations, and the pharmaceutical
industry to provide education about
medication errors and their prevention.The Institute
provides an independent review of medication
errors that have been voluntarily submitted by practitioners
to the national Medication Errors Reporting
Program (MERP) operated in the United States by the
United States Pharmacopeia (USP). ISMP is an accessible
resource for any pharmacist interested in implementing
the actions recommended herein. Among
the many ISMP products and services, the ISMP
Medication Safety Alert! is a biweekly newsletter
that provides timely information related to error prevention.
It identifies errors that have been reported
by other organizations and offers recommendations
to prevent those errors from occurring in the pharmacy.
The information in Tables 1 to 4 summarizes
many of the significant error-prevention strategies
that were recommended in the ISMP Medication
Safety Alert! during the last 12 months. The errors
presented in the accompanying tables include actual
or potential errors reported to ISMP. Each table consists
of 4 columns: The first column presents the
medications, devices, or other problematic issues
involved. The second column describes the specific
error or problem involved. The third column discusses
ISMP’s recommendations to proactively
address and prevent errors from occurring. The
fourth column lists technology that may assist in the
prevention of these errors. Technology certainly can
be a powerful tool in the fight against medication
errors but only when it is used appropriately within
a well-designed medication-use system.
The key summarizes the technology addressed
in the tables along with specific criteria that ISMP
believes should be included.
Suggested Readings
Cohen MR, ed. Medication Errors.Washington, DC:
American Pharmaceutical Association; 1999.
Institute for Safe Medication Practices Web site:
www.ismp.org.
Institute for Safe Medication Practices (2005-2006).
ISMP Medication Safety Alert! newsletter. Available
at www.ismp.org.
PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006 11

Table 2. Dangerous Abbreviations, Dose Designations, and Other Unsafe Ways of Communicating Orders
Communication Problem Recommendation(s) Technology
Changed directions create problem
Amoxicillin was prescribed as “200 mg/5 mL. Take 5 mL TID.” The prescribed
concentration was not available in the pharmacy, making the original directions
inaccurate. The dispensing pharmacist changed the directions to “Take 4 cc (4/5
teaspoonful).” The patient’s parent’s primary language was not English and the
measuring device was marked in mL and teaspoons, so the parent mistakenly
measured each dose as 4.5 teaspoons. The child was brought to the emergency
department with severe diarrhea.
Do not use “cc” or slash marks (/) as abbreviations.
Provide counseling for all new prescriptions, especially if the directions
for what is dispensed differ from what was originally prescribed.
5
Coumadin (warfarin sodium,
Bristol-Myers Squibb) order
misinterpreted due to “do not”
symbol
The “do not” symbol was used to indicate that a patient’s Coumadin dose
should not be given, but it was misinterpreted as 4 mg instead. The error was
caught before the patient received the unneeded 4 mg dose.
Remind practitioners to use clear language rather than symbols when
writing and transcribing orders.
1
Ideas for handling “hold” orders
Warfarin was placed on hold before an endoscopy but was not resumed after
the procedure. The patient suffered a stroke 6 days later.
An order to hold a medication also can result in resuming the medication too
soon.
If a patient is on daily medications based on laboratory results, the
pharmacy profile and the nursing MAR should reflect this as an ongoing
active order with a notation that a dose must be prescribed each day.
If medication doses are not guided by daily laboratory values, hold
orders should not be accepted unless they include specific instructions
for when to resume the medications.
All orders for medications that are held for a procedure should be
rewritten fully after the procedure.
1, 5
Is U really worth it?
An order looked like 90 units of LANTUS (insulin glargine, Aventis) to a
pharmacist, who then noticed that a clarification had already occurred on the
order. However, he thought the nurse had clarified the unusual dose of 90 units
and not the unapproved abbreviation (u), so he misinterpreted the order
clarification as “…dosage 15 units” instead of “…dosage is units,” and
dispensed 15 units. The correct dose was 90 units.
Avoid the use of dangerous abbreviations such as “u” for units because
it can lead to unnecessary confusion and the need for clarifications.
Anyone who clarifies a medication order should rewrite the entire order.
1, 5
Oral liquid given by I.V.
A long-term care nurse was unfamiliar with oral syringes and administered
TUSSIONEX (hydrocodone and chlorpheniramine, Celltech) suspension, which
was dispensed in an oral syringe, by the I.V. route. The manufacturer-printed
words “For oral use only” had been covered by the pharmacy label.
Never cover important information on any drug package. If this is not
possible, auxiliary labels are available with “For oral use only” printed
in large red characters that can be affixed to the syringe plunger.
Educate all staff about oral syringes and how their use can protect
against inadvertent administration by I.V.
2
Sliding scale insulin coverage
Sliding scale insulin orders may lead to misinterpretations if they are not clearly
communicated.
In one case, a physician prescribed insulin coverage for blood sugar between
0 and 180, potentially leading to the administration of insulin to a patient with
low or normal blood sugar.
Standardize sliding scale insulin coverage and use standard order sets
to clearly communicate orders.
If possible, do not use sliding scale insulin coverage as a routine method
of blood glucose control.
1, 2, 5
SYMLIN (pramlintide acetate,
Amylin Pharmaceuticals)
SYMLIN is dosed in micrograms, but the manufacturer recommends using a
dosing chart and an insulin syringe to measure each dose.
Using an insulin syringe, a patient or practitioner could become confused and
withdraw 30 units, for example, for a prescribed 30 mcg dose.
Prescribers have expressed the dose in “units” to match the syringe, also
potentially causing confusion.
Patient education and written dosing instructions are vital components
of Symlin therapy.
Patients also should be provided with comprehensive monitoring forms
on which to document all insulin and Symlin doses and corresponding
glucose levels.
1, 5
Units, mg, or mL
Growth hormone can be prescribed in milligrams or international units, causing
confusion.
Patients (or parents) may measure the doses using an insulin syringe, and
describe their growth hormone (somatropin) “doses” in units, when in fact they
are reporting a measurement of volume. When these “unit” doses are converted
to milligrams, the stated doses may appear to be too high and cause confusion.
Educate patients on growth hormones about the risk of confusion
between international units and milligrams, especially if they use an
insulin syringe to measure the dose.
Inform patients that they should be familiar with their microgram dose
and should understand that an insulin syringe is only being used to
measure the volume needed for the prescribed dose.
If the volumetric dose is large enough, patients should use a tuberculin
syringe instead.
None
12 PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006

Table 3. Problems Involving Drug Information, Staff Education, and Patient Education
Information Problem Recommendation(s) Technology
Inadvertent administration of
nimodipine (NIMOTOP, Bayer)
by I.V.
For patients who are unable to swallow and have a nasogastric (NG) tube in
place, doses of NIMOTOP can be prepared by extracting the contents of the
soft gelatin capsule into a syringe with an 18-gauge needle, administering it
via the NG tube, and flushing with 30 mL of saline. However, this procedure
is potentially dangerous, and there have been several reports in which the
drug was drawn into a parenteral syringe and accidentally given by I.V. The
inadvertent I.V. administration of the drug has resulted in severe hypotension,
cardiovascular collapse, and cardiac arrest.
Whenever nimodipine is dispensed, communicate the potential danger
of inadvertent I.V. injection directly to the person responsible for
administering the drug.
Put a reminder in the computer, on the drug container, and on product
labeling to help trigger this response.
1, 2, 4, 5
Chemical burns with PHENOL (89%)
A 3-year-old child attempted to drink a cup of PHENOL left on the counter of an
examination room in which the child’s mother was being treated. The cup of phenol
spilled down the child’s face and chest, causing immediate pain and irritation.
If possible, supply unit-dose phenol applicator kits (from Apdyne), which
reduce the potential for unintended exposure to this harsh chemical.
Limit access to treatment rooms for children who are not being treated.
None
CLIMARA (estradiol transdermal
system, Berlex)
The total amount of drug absorbed and the resulting plasma drug concentrations
from transdermal systems can increase during heat exposure.
One patient experienced hot flashes after several days of sun tanning while
wearing CLIMARA (once-a-week estradiol transdermal system). She also noticed
dark spots where her patch had been applied.
It is unknown whether an early release of estrogen from a heated patch
occurred, leading to an abrupt drop in continuous drug delivery, decreased
estrogen blood levels, and the subsequent symptoms.
Educate patients about problems associated with exposing transdermal
systems to excessive heat and the possibility of increased drug
absorption from medication patches.
5
PROPOFOL (various) sedation
Neuromuscular blocking agents
GLACIAL ACETIC ACID
Intestinal perforation after patient
swallows unit-dose packaging
MAGNESIUM SULFATE (various)
toxicity in obstetrics
Using PROPOFOL to sedate patients during endoscopic and other diagnostic
procedures is gaining momentum in a growing number of hospitals, outpatient
surgery centers, and physician offices.
Some practitioners have been lulled into a false sense of security, allowing the
drug’s good safety profile to influence their beliefs that propofol is safer than it
really is.
In untrained hands, propofol can be dangerous, even deadly; administration to a
nonventilated patient by a practitioner who is not trained in the use of drugs
that cause deep sedation and general anesthesia is not safe, even if the drug is
given under the direct supervision of the physician performing the procedure.
Neuromuscular blocking agents have been inadvertently administered to
patients who were not receiving ventilatory support. Some patients have died or
sustained permanent injuries.
Most incidents have taken place outside operating rooms, emergency departments,
and other critical care areas.
Despite warning statements on GLACIAL ACETIC ACID containers, harmful
mix-ups, where the concentrated form is dispensed instead of a diluted form,
continue to occur.
In one case of dispensing an undiluted form, a nurse called the pharmacy for
“acetic acid for irrigation” for a 31-year-old patient with bilateral greater
trochanter wounds. An experienced pharmacist, who was new to the institution,
placed glacial acetic acid at the window for pickup. The undiluted solution
resulted in burns to the extent that the wounds would not heal, necessitating
disarticulation at the hips.
Patients have been injured by swallowing plastic unit-dose packaging instead
of removing tablets prior to drug administration.
In one such incident, a man was injured by the sharp corner of a plastic blister
package that cut through all layers of the intestinal wall.
Practitioners who work in obstetrical units may feel comfortable administering
I.V. MAGNESIUM SULFATE, which is used to treat preterm labor and preeclampsia.
Yet, many errors have been reported with this medication, resulting in overdoses
of magnesium sulfate, and subsequent respiratory arrest and/or death in
patients. Most of the errors were due to unfamiliarity with safe dosage ranges
and signs of toxicity, inadequate patient monitoring, pump programming errors,
and mix-ups between magnesium sulfate and oxytocin.
Within your organization, have an interdisciplinary team, including
the chair of the anesthesia department, establish policies and practice
guidelines for the administration of propofol to nonventilated patients
undergoing surgical or diagnostic procedures.
Allow floor stock of these agents only in the operating room, emergency
department, and critical care units.
Sequester in both refrigerated and nonrefrigerated locations.
Affix fluorescent red warning labels on products that note: “Warning:
Paralyzing Agent—Causes Respiratory Arrest.”
Remove glacial acetic acid from stock.
Purchase diluted acetic acid from external sources. If this is not possible,
dilute the product in the concentrations needed immediately upon
delivery of the chemical.
Place more prominent alert messages on storage shelves and bottles.
Require an order for acetic acid that includes the exact strength necessary.
Educate all staff about the properties of glacial acetic acid.
Always provide patient education on proper drug administration if
patients are administering medications to themselves.
Confused, somnolent, or visually impaired patients should never be
handed wrapped packages of medications.
Consider the use of a standard concentration of commercially available
premixed solutions for bolus doses and maintenance infusions.
Label the I.V. tubing near the I.V. pump, and establish dosing and administration
protocols and standard order sets for magnesium sulfate; independently
double-check the drug, concentration, infusion rate, pump settings,
line attachment, and patient before administering I.V. magnesium sulfate.
Frequently monitor patients’ vital signs, oxygen saturation, deep tendon
reflexes, and level of consciousness (also fetal heart rates and maternal
uterine activity if the drug is used for preterm labor).
1, 3, 5
1, 2, 4, 5
2
None
1, 2, 3, 4, 5
New FENTANYL (various) warnings;
more needed to protect patients
Some patients and their healthcare providers may not be fully aware of the
dangers of FENTANYL products and the important recommendations regarding
the safe use of this potent narcotic agent.
In one incident, a woman, who had chronic pain from Crohn’s disease, reported
that her 4-year-old son either used a discarded patch retrieved from the trash or
opened a wrapper of a patch from a box of stored patches, and applied one to
his body. His mother found him dead on the floor of a bedroom, near an
overturned trash can that held torn wrappers and discarded patches.
Thoroughly review the recent alert from Janssen. (www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf)
as well as the July 15, 2005,
FDA Public Health Advisory about changes to product labeling.
Select patients appropriate for this therapy, educate patients, and take
steps to ensure safe use and disposal of the products.
Improve the methods of documentation to help guard against applying
multiple patches to patients.
1, 2, 4, 5
PHYTONADIONE (Vitamin K 1 ) as
pharmacy trigger
PHYTONADIONE has been prescribed as an aggressive attempt to reverse the
effects of warfarin in preparation for a procedure.
The long-term effects of phytonadione administration may last up to a week,
causing prescribers to later inappropriately increase warfarin doses over several
days. The resulting warfarin dose may be dangerously high.
Investigate all orders for phytonadione 10 mg or higher.
Determine the circumstances of an adverse drug event from unintentional
bleeding due to warfarin or of intentional pre-procedure reversal of
warfarin.
If intentional, recommend a lower post-procedure warfarin dose once
restarted.
Considering how many hospital pharmacy computer systems are today,
pharmacists should not consistently depend on this technology to detect
potentially harmful medication errors.
Test your organization’s computer system and identify weaknesses that
can be targeted to improve and safeguard against medication errors.
Contact vendors for pharmacy software and drug information providers
to request any necessary changes.
1, 5
Safety still compromised by
computer weaknesses
An ISMP survey showed alarming findings that pharmacy computer systems in
this country are vastly unreliable when used to detect and correct prescription
errors or pharmacy order entry errors. These findings indicate that there has
been little improvement with pharmacy computer systems over the past 6 years
to safeguard against medication errors.
5
PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006 13

Table 4. Medical Devices and Other Discussion Items
Title Problem/Discussion Point Recommendation(s) Technology
An exhausted workforce increases
the risk of errors
Long work hours and the fatigue that results represent a serious threat to
patient safety. Among its many effects, fatigue diminishes the ability to
recognize important but subtle changes in a patient’s health and reduces
the ability to deal with unexpected events. In fact, prolonged wakefulness
leaves a person with the equivalent of a blood alcohol concentration of 0.1%
(above the legal driving limit).
Provide managers with information about the risks of fatigue, circadian
rhythm disturbances, and approaches to optimize performance.
Set limitations on the hours worked each day and week, and for specific,
potentially fatiguing physical and mental tasks.
Whenever possible, recognize the circadian rhythm principles when
designing work schedules.
Planned breaks and naps, light therapy, and access to nutritious meals
also can help to combat the effects of fatigue.
None
Apologies gain momentum
A decade ago, physicians were told, implicitly or explicitly, during their
professional training to avoid making apologies to patients for medical errors
because this could lead to problems if they are sued. Today, some healthcare
executives, insurers, and physicians are changing this mindset and are fully
embracing disclosure and apologies, not only because they believe this will
reduce malpractice claims but also because ethically this is the right thing to do.
Consider developing a disclosure policy that establishes detailed
procedures for physicians to acknowledge medical errors and, if
possible, offers fair compensation for expenses related to the medical
injuries.
None
False glucose results with
point-of-care testing
Administration of certain substances can result in erroneously high values when
monitoring blood glucose with certain point-of-care glucose meters.
In one case, the I.V. administration of an immunoglobulin product formulated
with maltose led to falsely elevated glucose meter results and the inappropriate
escalation of a patient’s insulin dose.
Similar problems have been reported with other products formulated with
maltose or icodextrin.
Create special alerts in the pharmacy computer system to remind pharmacists
about the potential for false glucose readings when entering
orders for products that may affect the accuracy of the glucose monitors.
Communicate the information to the nursing staff and add a cautionary
note to the MAR under the drug entry for insulin.
Include the risk of false glucose determinations, and the specific
circumstances surrounding this risk, in protocols for insulin administration
according to glucose values.
Remind staff to “treat the patient, not the glucose meter,” and always
correlate the patient’s symptoms with the glucose meter reading before
insulin administration, especially in cases in which the glucose readings
are very high or very low.
1, 2, 5
Filtered pump sets and epoprostenol
(FLOLAN, GlaxoSmithKline)
interruption
Administration set tubing that connects to the pump’s drug cassette at one end
and the patient’s I.V. line at the other has a filter in line that allows one-way
flow through the filter. Mistakenly connecting the wrong end of the tubing to
the infusion pump may interrupt the flow of FLOLAN and cause severe
worsening of pulmonary hypertension and even death in minutes.
Properly identify the distal and proximal ends of the administration set
before connecting.
Labeling the end of the tubing with the filter with a sticker “filter end to
patient” may serve as a reminder to the nursing staff.
None
Inhaler dust caps protect from more
than dust
A patient had to have a dime removed from his trachea after using his albuterol
inhaler, which he had kept in his pocket without a dust cap on it.
When educating patients on proper inhaler use, be sure to remind them
to keep the dust cap in place when the inhaler is not in use.
None
Medtronic SYNCHROMED pump
fatal injection
An inadvertent intraspinal injection occurred due to a mix-up of access kits
and inadequate labeling on the templates. The patient received nearly 1 g of
morphine (18 mL of a 50 mg/mL solution) through the catheter access port of an
implanted Medtronic SYNCHROMED pump instead of through the drug reservoir.
Overlay templates currently supplied with each kit (refill and catheter access)
do not display any text indicating which template is in use; nor do they display
warnings against accidental injection into the wrong port.
Until changes are made to the kits and templates, verify credentials and
competencies for any staff who stock and/or dispense the kits or refill
the devices.
Segregate the catheter access kits in storage areas and add auxiliary
warning labels to them.
1, 5
Monitoring alarms mistakenly
interpreted as a technical problem
leading to neonatal death
Patient tampering with opioid
infusion pumps
A neonate was given arterial solution that was compounded with concentrated
sodium chloride (23.4%) instead of sterile water. When the nurses began to
experience what they perceived to be technical problems with the inline
monitor, the monitor was replaced. When this replacement monitor seemed
to be faulty, it also was replaced. Approximately 18 hours later, the monitor
displayed a sodium level of more than 190 mmol/L. The patient deteriorated
and required several interventions, but there was no change in serum sodium
level, and the baby died.
A patient with a history of chronic pain was admitted to the hospital and
permitted to use the opioid-infusing pump he had brought from home. It
was discovered that the patient had been able to alter pump settings with
knowledge of lock level and clinician bolus codes.
Never assume that equipment malfunction is the sole cause for what
appears to be an abnormal clinical value; this can delay rescue from harm.
Never completely cover the manufacturer’s label with the patient label
because this prohibits an independent double check by nursing personnel.
Use only hospital-approved pumps to administer opioids to hospitalized
patients.
Monitor prescribed doses against doses dispensed and administered.
Educate staff to shield pump programming codes and actions from
non-clinicians.
Consider having biomedical engineering change codes temporarily as
long as the new codes can be securely communicated to those who
need the information.
None
3
V.A.C. INSTILL SYSTEM (Kinetic
Concepts, Inc.) may pose a risk
for I.V. misconnections
The V.A.C. INSTILL SYSTEM by KCI is a wound healing system that facilitates
automated delivery of topical solutions to wound sites. While very different from
an infusion pump, the device is programmed to deliver a desired rate of infusion;
however, it lacks protection from gravity free-flow if the tubing is removed. The
device is designed to accommodate I.V. tubing to deliver the topical solution,
and one could inadvertently attach the I.V. tubing intended for the V.A.C. to an
I.V. port.
Prepare topical solutions in a container dissimilar to typical I.V. solutions,
such as a 500-mL bottle.
Misconnections also are less likely if you label all lines; affix bold
cautionary labels to topical solutions, and physically trace all lines from
the source solution to the port of insertion.
None
14 PHARMACY PRACTICE NEWS SPECIAL EDITION • 2006