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Preventing Medication Errors

Author:
Kathleen A. Mahackian, PharmD
UC Davis Medical Center
Sacramento, California
The CE Solution, Inc. is approved by the Accreditation
Council for Pharmacy Education as a provider of
continuing pharmacy education.
This program reflects the opinion(s) of the author(s) and may not reflect those of the sponsor or
publisher. While all reasonable attempts have been made to assure the accuracy of the
information contained in this program based on current scientific knowledge at the time of
publication, the reader is advised to evaluate their individual patients condition, compare
information discussed or suggested with recommendations from other authorities, and refer to the
official prescribing literature for the latest information on new or highly toxic drugs prior to
administration or dispensing.
Statements made in this program have not been evaluated by the Food and Drug Administration.
Discussion of published or investigational uses of drugs outside of approved labeling is offered for
educational purposes only, and the sponsor and publisher of this program do not endorse such
off-label use. Nutritional products discussed are not intended for the prevention, diagnosis,
treatment, or cure of any disease.

GOAL
To identify problems associated with the medication use process and provide strategies to
eliminate or significantly reduce medication errors
LEARNING OBJECTIVES
Upon completion, the nurse should be able to:
1. Identify two strategies that can prevent errors resulting from look-alike/soundalike medication names;
2. Describe the difference between root cause analysis and failure mode and
effects analysis;
3. List three resources for obtaining best practice information;
4. Recognize how the formulary process can reduce medication errors;
5. Identify five high-alert medications and select an error prevention strategy for
each.

MEDICATION ERRORS TAKE CENTER STAGE


The Institute of Medicine (IOM) report estimated that between 44,000-98,000 patients die each
1
year as a result of medical errors. Focusing on the medication error portion of the puzzle, it is
estimated that approximately $2 billion is spent on treating hospitalized patients for preventable
adverse drug events. One review of adverse drug reaction literature estimates that over 50% of
2
drug-related admissions are preventable and therefore considered medication errors. After the
release of the IOM report in 1999, the stage was set for reform.
Many individuals point to the release of the IOM report, "To Err is Human: Building a Safer Health
System," as the catalyst for medication error reform. In reality, medication errors have been
studied for over 30 years. Many high profile cases, such as the fatal error at Dana Farber Cancer
Institute in 1995, served to focus media attention on the problem; and many groups, such as The
National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP),
Institute for Safe Medication Practices (ISMP), and the National Patient Safety Foundation
(NPSF) came into being years before the release of the IOM report. While much had been
accomplished in pursuit of enhanced patient safety, there were really no incentives or
requirements for hospitals, clinics, or pharmacies to implement changes to improve care. The
IOM report changed all that, and there has been an increase in state and federal legislation
aimed at reducing medical errors. Some of the currently proposed legislation address
3,4
confidentiality, voluntary and mandatory reporting of errors, and legal protection. There has also
been more of an emphasis on patient safety by the FDA, accrediting organizations such as the
JCAHO, business communities, and professional societies.
ESTABLISHING A CULTURE OF SAFETY
Patient safety must be a priority throughout an organization, be it hospital, clinic, or community
pharmacy. In order to prevent errors, an institution must have an error reporting process in place
that is blame free. To encourage reporting, practitioners must feel that they can report errors in a
non-punitive environment. A focus on "who" rather than "what" went wrong limits the institution's
ability to identify and correct systems' problems and discourages reporting. Strategies to promote
a blame-free environment include rewarding those who report errors, implementing a reporting
mechanism that focuses on systems' problems, and prohibiting the use of error reports in
performance evaluations.
It is also important to recognize that many healthcare professionals are involved in the
medication-use system. If dispensing were the only step in the medication-use process, the
pharmacist alone could solve all of the medication error problems. Medication errors involve all
aspects of the medication-use process: prescribing, documenting (transcribing), dispensing,
administering, and monitoring. These processes are intimately related, and changes in one often
affect another.
Due to the complexity of the medication-use process, improvements require collaborative efforts
from all healthcare professionals. Development of a multidisciplinary committee to address
medication errors in the hospital setting should be an integral part of a medication error
management program. This committee should address all aspects of care in the health system,
both inpatient and outpatient.
It is equally important for pharmacy practice sites other than hospitals to follow the model of
encouraging error reporting and establishing a blame-free environment. While an interdisciplinary
committee might not be an option in these settings, it is essential to involve all employees at the
practice site in identifying and eliminating systems' weaknesses that will reduce medication errors
and improve the practice. Including pharmacists and technicians in medication error analysis

heightens their awareness to common medication errors and encourages problem solving.
Implementing systems changes, then, is easier as there is "buy in" from those involved in the
process.
To successfully establish a culture of safety, a hospital or community pharmacy should:

Create a blame free environment;


Reward and encourage error reporting;
Focus on systems' problems;
Use medication error data to drive changes and identify training opportunities;
When possible, include a multidisciplinary approach to error prevention.

Many institutions perform safety surveys to determine individual attitudes and perceptions
5
regarding their error reporting process. These surveys, sometimes obtained from other
industries, assist the institution in identifying problems with how their medication safety process is
perceived by the staff. These surveys solicit input from staff members about ease of reporting,
willingness to report (or fear of punitive action), and their understanding of the overall medication
safety process. Analysis of survey results then addressing concerns expressed by the staff can
lead to significant improvements. For smaller practice sites, such as clinics or community
pharmacies, encouraging open discussions at staff meetings rather than formal safety surveys
can be used to gauge staff attitudes and perceptions.
PRESCRIBING ISSUES
Whether hospital, independent, or chain store pharmacy, dispensing usually starts with a written
or verbal order. There are multiple potential problems associated with the prescribing process
6,7
that produces this order :

Illegible handwriting;
Use of dangerous abbreviations;
Leading and trailing zeroes;
Look-alike/sound-alike drug names;
Incomplete prescriptions;
Unavailable patient information.

Hand-written Prescription Orders


Illegible handwriting can lead to misinterpretation of the order. Couple poor handwriting with
either dangerous abbreviations or look-alike drug names, for example, and the likelihood of a
medication error increases.
Legibility has been a problem with prescription writing for decades with various attempts at
eliminating this problem. Many medical schools offer lectures on prescription writing in an attempt
to avoid the development of "bad habits." These classes heighten awareness as to the
importance of legibility, as well as teach other safe practices for prescription writing to future
clinicians.
Another strategy for preventing errors due to legibility issues is to develop preprinted order forms.
This approach can minimize legibility problems and address some of the other prescribing
problems mentioned in this section (dangerous abbreviations, incomplete prescriptions).
Computer Physician/Practitioner Order Entry (CPOE), which will be discussed later, is another
strategy that has been shown to eliminate legibility errors.
The Use of Abbreviations

A patient safety goal of the JCAHO (Joint Committee on Accreditation of Healthcare


8
Organizations) adopted in 2003 is to improve communication within healthcare organizations. A
key objective is the standardization of abbreviations, acronyms, and symbols used throughout
organizations. Part of the process includes identifying abbreviations that should never be used in
practice, since abbreviations can have multiple meanings or be similar in appearance.
Misinterpretation of abbreviations sometimes leads to significant patient harm. Both the ISMP as
well as the NCC MERP have publicized lists of abbreviations that are frequently misunderstood
6
and associated with errors. Examples of some of the more commonly used "dangerous
abbreviations" are:

The letter "u" for units;


g for mcg;
QOD (every other day), QID (four times a day), and QD (daily);
D/C for discontinue or discharge.

For example:

The letter u has been mistaken as a zero or a four. An insulin order for 3u can result in
the administration of 30 or 34 units, possibly causing hypoglycemia.
It's easy to understand that QOD, QID, and QD can be mistaken for each other when
written. An order for amlodipine 10 mg po QD can be misinterpreted as QID, especially if
written as Q.D. The period between the q and d can be misinterpreted as the i, and the
medication mistakenly administered four times daily instead of once daily.
Using the g abbreviation can be misinterpreted as mg.
D/C can be interpreted as "discharge" or "discontinue." Improperly interpreting this
abbreviation can lead to prematurely discontinuing critical medications.

Use of dangerous abbreviations is a widespread and difficult problem to solve. Heightening


clinician's awareness of the problem by publicizing a list of dangerous abbreviations is the first
step in addressing this problem. Auditing the use of abbreviations and giving feedback to
prescribers is another option in eliminating the use of dangerous abbreviations. As mentioned
before, preprinted orders and CPOE are both effective strategies to minimize or eliminate the use
of abbreviations.
Errors Involving Zeroes
Two other error-prone practices associated with prescription writing are the use of trailing zeros
and the absence of a leading zero. Including a trailing zero is particularly dangerous in situations
where multiple strengths of the medication are available, such as warfarin. If a physician writes a
prescription as "1.0mg", there is a risk that the pharmacist will misinterpret this order as "10mg"
resulting in an overdose and possible bleeding complications. This error is particularly
problematic for outpatient prescriptions, as the error could go undetected for several days or
weeks increasing the likelihood of adverse outcomes. In the hospitalized patient, intensive
monitoring of the patient's anticoagulant response is possible increasing the likelihood that the
error will be discovered and corrected.
9

The absence of a leading zero results in similar 10-fold dosing errors. In a study by Lesar on
tenfold dosing errors related to prescribing, numerous 10-fold errors could be tracked to the use
of trailing zeros or absence of leading zeros. In one case, a patient misinterpreted the prescription
label that included a trailing zero thus providing an incorrect dosing history to the physician. This
illustrates how violating safety rules can lead to errors even when there is not a legibility issue.
Pharmacy systems should default to using a leading zero and delete a trailing zero on labels
thereby preventing patient confusion as to the dose of medication they are taking.
Look-alike Drug Names

Look-alike names (brand-brand, brand-generic, and generic-generic) are another source of


medication errors (Table 1). Recently, JCAHO added a national patient safety goal (NPSG)
addressing the look-alike name issue (NPSG 3C). This new goal will require institutions to identify
certain look-alike drug names and implement strategies to prevent errors associated with these
medication name mix-ups. The JCAHO website is a valuable resource for look-alike and soundalike drug names and includes information on preventing mix-ups for many problematic
10
medications. These look-alike names cause errors in all aspects of the medication-use process:
prescribing, transcribing, and dispensing of medications. There are many issues that contribute to
5,10-12
an error associated with a look-alike name.

Poor handwriting-leads to misinterpretation of a written order.


Nonformulary medications-pharmacy and/or nursing staff may be unfamiliar with
nonformulary medications and may mistake the order for a look-alike formulary
medication.
Newly marketed medication-clinicians may not be familiar with a new medication and can
mistake it for a look-alike medication that has been in use for a longer period of time.

Table 1. Examples of Look-Alike and Sound-Alike Medication Names*


Adriamycin
Idamycin
Aggrenox
Aggrastat
Akarpine
Atropine
Alkeran
Leukeran
Brevibloc
Brevital
Bupivacaine
Ropivacaine
Bupropion
Buspirone
Cafergot
Carafate
Calcitriol
Calciferol
Carboplatin
Cisplatin

Celebrex Celexa
Cerebra
Dopamine
Dobutamine
DiaBeta Zebeta

Hydralazine
Hydroxyzine
Imdur Imuran

Phenobarbital
Pentobarbital
Quinidine Quinine

Inderal Isordil

Relafen Rezulin

Diprivan Diflucan

Klonopin
Clonidine
Lamisil Lamictal

Retrovir Ritonavir

Lodine Codeine

Eldepryl
Enalapril
Equagesic
EquiGesic
Etomidate
Etidronate
Folic acid Folinic
acid

Lopid Slo-bid

Seroquel Serentil
Serzone
Sulfasalazine
Sulfadiazine
Tobrex TobraDex

Cardene
Cardizem

Glipizide
Glyburide

Cardura
Coumadin
Ceftazidime
Ceftizoxime

Guaifenesin
Guanfacine
Humalog
Humulin

Nicardipine
Nifedipine
Nimodipine
Oxycodone
OxyContin
Paxil Plavix

Doxorubicin Daunorubicin
Efudex Eurax

Lorazepam
Clonazepam
Mitomycin
Mitoxantrone
Nelfinavir
Nevirapine

Rifabutin Rifampin

Vanceril Vancenase
Vancomycin
Vecuronium
Vesicare Visicol
Viramune Viracept
Zosyn Zofran

*For a more complete list of look-alike/sound-alike drug names visit: www.usp.org


Prior to the increased attention to medication safety, little consideration was
given to patient safety when developing brand and generic names for new drug

products. Marketing was the driving force when developing drug names. The
IOM Report, as well as newer FDA standards requiring safety testing of
trademarks, has become a motivating factor for many pharmaceutical companies
to improve the selection of new drug names with an emphasis on safety. The
Med-ERRS, Inc, a subsidiary of the ISMP established in 1997, will evaluate
proposed medication names in order to identify and prevent potential sound-alike
and look-alike confusion with existing products. When pharmaceutical companies
contract with Med-ERRS for a fee, feedback is obtained from physicians,
pharmacists, and nurses about possible similarity between the proposed name
and existing medication names.13 This group also evaluates the design of drug
packaging and labeling to maximize safety.
In addition to the Med-ERRS group, the Office of Postmarketing Drug Risk
Assessment (OPDRA) was formed by the FDA in October 1999. In 2002, the
OPDRA was renamed the Office of Drug Safety (ODS). The ODS consists of
three divisions: the division of Drug Risk Evaluation (DDRE); the division of
Medication Errors and Technical Support (DMETS); and the division of
Surveillance, Research and Communication Support (SRCS). DMETS provides
pre-marketing review of all proprietary names, labels, and labeling. Part of this
process includes an expert panel review of the proposed name. Safety
evaluators conduct literature and computer database searches and send
approximately 100 health professionals simulated written prescriptions to assess
the proposed name for look-alike problems. Names are compared to currently
marketed drug names, other medicinal products, and to commonly used medical
abbreviations, procedures, and/or lab tests. The drugs are evaluated for
overlapping strengths and similar regimens that could increase the likelihood of
an error with a look-alike medication. The drugs are also evaluated for similar
indications, use in the same patient population, and/or storage in the same area
as a sound-alike or look-alike medication.
While there is a mechanism now in place to address the process of assigning
new drug names, the risk of medication errors from look-alike, sound-alike drugs
still exists. One strategy aimed at minimizing prescribing errors associated with
look-alike drug names is for the physician to include the medication's indication
on the prescription. This gives the pharmacist additional information to validate
his/her interpretation of the prescription. For example, an order for hydroxyzine
50 mg PO q6h for itching is not likely to be misinterpreted as hydralazine. As
discussed earlier, preprinted orders or physician order entry systems will prevent
those look-alike medication errors where handwriting plays a role.
Sound-alike Drug Names
Verbal orders are a source of errors with sound-alike drug names. Oftentimes the
actual transmittal of a verbal order is problem prone.14 Speech patterns
(speaking too fast, too softly, with an accent, etc.) affect the ability of a
pharmacist to accurately receive and transcribe the order. Further, the
environment of the healthcare provider receiving the order can be filled with
distracting noises (faxes, equipment alarms, co-worker conversations, etc.).

Strengths and directions for use can also be misinterpreted when taking verbal
orders (eg, 15 confused for 50). The entire process is fraught with the potential
for miscommunication and errors.
Ambulatory clinics and physicians' offices will oftentimes "call in" prescriptions.
This process usually starts with a written order (which is subject to all of the
problems associated with written prescriptions) that is then phoned to a
pharmacy. The nurse calling in the prescription may be unfamiliar with the drug
name, doses, and indications. This can lead to mispronunciation of the drug
name or misreading of dosing instructions to the pharmacy. The more steps and
intermediaries (eg, nurse or clerk) introduced into the process, the more likely an
error will occur. This is also true when a patient requests a transfer of a
prescription from one pharmacy to another. The procedure of transmitting the
prescription from pharmacy 1 to pharmacy 2 is yet another opportunity for
introducing error into the process.
Safe practices would dictate:

Use verbal orders only for emergency situations when a written order is
not possible.
Always read back a verbal order so that the prescriber can validate the
order.
Obtain the indication for the prescribed drug; as with written prescriptions,
this piece of information can serve to validate the drug choice.
Prohibit the use of verbal orders for certain high-risk medications, such as
chemotherapy.
Establish policies on who can receive verbal orders.
Whenever possible, the prescriber should call in prescriptions to the
pharmacy.
The pharmacist should ask to speak to the prescriber directly if there are
any questions regarding a prescription that is being called in by office
personnel.

Incomplete Information
The final problems mentioned that might be encountered during the prescribing
process, incomplete prescriptions and unavailable patient information, are
obvious potential sources of error if the dispenser merely guesses at what the
prescriber intended without verifying the actual intent and obtaining complete
information before processing.

DISPENSING ISSUES
Look-alike names also plague the dispensing aspect of the medication-use
system. Pharmacy generated labels can use small fonts that may be difficult to
read. This can increase the likelihood of an error due to look-alike names. In

March 2001, the FDA Office of Generic Drugs asked manufacturers of 16 pairs of
drugs with look-alike names to voluntarily change the appearance of the name on
the label using "tall man" letters to visually distinguish the names (Table 2). 15
Table 2. OGDs Tall Man Name Differentiation Project
Established Appearance
Proposed Appearance
Acetohexamide
AcetaHEXAMIDE
Acetazolamide
AcetaZOLAMIDE
Bupropion
BuPROPion
Buspirone
BusPIRone
Chlorpromazine
ChlorproMAZINE
Chlorpropamide
ChlorproPAMIDE
Clomiphene
ClomiPHENE
Clomipramine
ClomiPRAMINE
Cyclosporine
CycloSPORINE
Cycloserine
CycloSERINE
Daunorubicin
DAUNOrubicin
Doxorubicin
DOXOrubicin
Dimenhydrinate
DimenhyDRINATE
Diphendydramine
DiphenhydrAMINE
Dobutamine
DOBUTamine
Dopamine
DOPamine
Glipizide
GlipiZIDE
Glyburide
GlyBURIDE
Hydralazine
HydrALAZINE
Hydroxyzine
HydrOXYzine
Medroxyprogesterone
MedroxyPROGESTERone
Methylprednisolone
MethylPREDNISolone
Methyltestosterone
MethylTESTOSTERone
Nicardipine
NiCARdipine
Nifedipine
NIFEdipine
Prednisone
PredniSONE
Prednisolone
PrednisoLONE
Sulfadiazine
SulfADIAZINE
Sulfisoxazole
SulfiSOXAZOLE
Tolazamide
TOLAZamide
Tolbutamide
TOLBUTamide
Vinblastine
VinBLAStine
Vincristine
VinCRIStine

The changes proposed by the FDA could be duplicated in pharmacy medication


dispensing processes to minimize errors associated with look-alike medication
names. Some of strategies to prevent dispensing errors due to look-alike names
include:

Incorporate alerts in the pharmacy computer system;


Incorporate the FDA proposed changes (using tall man letters) onto
pharmacy-generated labels or into pharmacy computer systems;
Flag shelves where the look-alike products are stored;

Do not store problem medications alphabetically;


Use both brand and generic names on medication labels and provide both
names to the patient;
Use a formulary system to limit the availability of problem-prone, lookalike/sound-alike medications. If sound-alike/look-alike medications must
be added, risk assessment and error prevention strategies should be
developed as part of the formulary addition process.

It is important to note that look-alike errors affect all aspects of the medicationuse system: prescribing, transcribing, dispensing, and administering. One goal in
the prevention of errors due to look-alike medication names is to increase the
"visibility" of the error, thereby increasing the likelihood that the error will be
discovered. It is essential to ensure that at least a double check of the order
occurs. The nurse and pharmacist need to independently review the order, which
increases the likelihood that a written order subject to misinterpretation will be
discovered. In the hospital, requiring a pharmacist's review of orders prior to
nurse administration (ie, removing the medication from floor stock, prohibiting the
nurse from obtaining the medication from an automatic dispensing machine prior
to pharmacist review) is an essential part of making sure the double check takes
place. Alerts that flag look-alike names in automated dispensing machines can
serve to heighten the nurse's awareness to the potential for misinterpretation.
Packaging can also contribute to dispensing errors. Vials of similar size and
shape, or products with similar appearing labels, can be confused resulting in
medication errors and adverse drug reactions. The ODS also has responsibility
for reviewing packaging issues as well as drug names. The packaging review
attempts to determine if multiple strengths are distinguishable, if there is a
possibility of confusion with another product, and if an error with a product could
have a serious outcome. While some error-reduction strategies such as labeling
shelves or posting warnings about look-alike packaging can have some impact,
the technology that will significantly reduce packaging related errors is bar coding
(which will be covered later in this article).
Other factors have been found to affect the accuracy of dispensing. Process
errors have been studied by Grasha and psychological patterns identified that
could be applied in developing error reduction strategies.16 Here are some of his
findings and strategies.

More process errors occurred when going from high to low workload, or
while working under low workload conditions. Findings suggest that there
can be a lack of focus, boredom, or interruption of work rhythm.
Regulating workload to prevent dramatic differences in workload is one
possible strategy for error reduction.
Adequate lighting is important in reducing errors. Findings indicated that
fewer process errors were identified if lighting was perceived as adequate.
Eye-level script holders resulted in a 30% reduction in reported process

errors.
HIGH-ALERT MEDICATIONS
Medications are deemed high alert not because they are more prone to errors
than other medications but because of the serious harm that can result from
administering the drug in error. As early as 1993, certain medications were
tagged as "today's poisons." Some of those same medications still remain as
high-alert medications (Table 3).6 JCAHO has made one high-alert medication a
priority by including it in one of its patient safety goals.6 In order to improve the
safety of high-alert medications, the goal states that concentrated electrolytes
should be removed from patient care units and that institutions should
standardize and limit the number of drug concentrations available.

Table 3. High-Alert Medications


Adrenergic Agonists
Digoxin
Theophylline
Heparin, thrombolytics
and warfarin
Benzodiazepines
*Hypertonic and
hypotonic saline
*Intravenous calcium Insulin
Chemotherapeutic
agents
Chloral hydrate

Oral hypoglycemic agents

*Potassium (Chloride or
phosphate
*Included in JCAHO patient safety goal

Lidocaine
*Intravenous magnesium
Narcotic and opiates
Neuromuscular blocking
agents
Cardioplegia
Colchicine

Each high-alert medication has its own set of breakdown points and possible
solutions. Some of the measures implemented to prevent problems with highalert medications can include:

Limit availability of medication (remove from floor stock);


Utilize double checks; can occur at the dispensing or administering point
of the medication-use process;
Utilize caution labels;
Review storage practices for those items that must remain available for
use;
Standardize ordering procedures; use pre-printed orders when possible;
Use premixed solutions when possible;
Require double checks on calculations;
Use only pumps that are protected from free flow;
Implement maximum dosing alerts in pharmacy computer systems;
Develop standards for monitoring of some high-alert medications;
Prohibit bolus doses from infusion bags.

One of the most effective methods of preventing errors from the high-alert
medications is to perform a Failure Mode and Effects Analysis (FMEA) for
ordering, storing, dispensing, or administering these drugs. The FMEA process is
a systematic approach to prevent process problems before they occur. An
institution can look at a new drug, high-alert drug, and dispensing process and
proactively identify system flaws before an error or bad outcome occurs. The VA
National Center for Patient Safety has developed a system of utilizing the FMEA
process that can be applied to health care.17 Steps in the process include:
Define the topic;
Form the team;
Describe the process (flow diagram);
Identify where and how the process can fail;
Conduct a hazard analysis that includes developing a severity-rating tool
(Table 4) and a probability-rating tool (Table 5) to identify the high-risk
aspects of a process. Table 6 identifies how the severity and probability
rating can then be used to determine an overall hazard score for a
process.
6. Develop an action plan for processes identified by the team as posing a
significant hazard;
7. Determine outcome measures.
1.
2.
3.
4.
5.

Table 4. VA NCPS Severity Rating Tool


Severity Rating
Rank
Catastrophic
4
Major
3
Moderate
2
Minor
1
Table 5. VA NCPS Probability Rating Tool
Probability Rating
Rank
Frequent
4
Occasional
3
Uncommon
2
Remote
1
Table 6. Overall Hazard Score Based on Probability and Severity
Severity of Effect
Probability
Catastrophic Major
Moderate Minor
Frequent
16
12
8
4
Occasional
12
9
6
3
Uncommon
8
6
4
2
Remote
4
3
2
1

Tables 4, 5, and 6 outline the scoring for FMEA, however the team should define
what is meant by the listed ratings. The team may define a catastrophic event
(Table 4) as patient death or permanent harm; a moderate event may be defined

as initial or prolonged hospital stay. The team must also define what the
frequencies mean. Frequent (Table 5) may be defined by the team as something
that will happen several times in a year; an uncommon event may happen
sometimes in 2-5 years, for example.
Determining these scores can be subjective and relies heavily on the expertise of
the team members. Teams may want to focus on processes with hazard scores
of 8 or above. For example, administering concentrated potassium chloride might
be an issue that is examined by FMEA. If a patient received concentrated KCl by
injection, this could result in death (catastrophic=score 4). Through discussions,
the team determines that the frequency is "uncommon" (score 2). The overall
hazard score would be 8, and the team would then identify this as an issue that
needs further evaluation and action. While this example is straightforward,
anticipating probability ratings and severity ratings for new processes or drugs
can be difficult and again, the multidisciplinary expertise is essential for a
successful analysis and outcome.
ROOT CAUSE ANALYSIS
A sentinel event is defined as an "unexpected occurrence or variation involving
death or serious physical or psychological injury, or the risk thereof."18 JCAHO
expects, as part of the investigation into a serious event, a root cause analysis be
performed. The process of "getting to the root of the problem" can be applied to
any systems-related error. Much like FMEA, a root cause analysis requires a
multidisciplinary team of individuals who understand the process, diagrams to
map the process, and identification of weaknesses in the system. In the case of
the root cause analysis, the goal is to identify what actually went wrong in the
process (FMEA focuses on what could go wrong). An effective root cause
analysis:

Involves team members knowledgeable in the processes associated with


the event;
Identifies causes;
Analyzes all systems associated with the cause;
Considers relevant literature;
Identifies possible improvements;
Outlines the plan for implementation of improvements;
Assigns responsibility for auditing performance after implementation of
improvements.

Many quality improvement tools can be utilized when performing root cause
analysis. Flow charts and diagrams offer visual representations of the steps in a
process. A cause-and-effect diagram can be useful in showing how different
processes are related, and how changing one process can adversely affect the
outcome of another process. Team "brainstorming sessions" to identify possible
causes of an error can be particularly valuable. Discussions should include all

team members, as sometimes it is those with little experience in a particular


process who are more likely to question the wisdom of a current process.
Sample Case
PG was a hospitalized 78-year-old male who developed signs and symptoms
consistent with gout. Due to some nausea the patient was experiencing, the
physician ordered colchicine 2 mg IV now, then 1 mg IV q6h until relief. He
received the medication for 2 days (total dose=9mg). The patient developed
aplastic anemia, became septic, and died 25 days later.
Key issue of event.The patient received doses in excess of the recommended
4 mg/course maximum. Doses exceeding 2 mg/dose and 4 mg/course have been
associated with thrombocytopenia, pancytopenia, and agranulocytosis.
Performing the Root Cause Analysis
Team assembled.Members assembled to analyze this case were:

Risk management representative


Quality improvement department representative
Rheumatology physician
General Medicine physician
Clinical pharmacist from general medicine floor
Pharmacist for central operations area
Medication Safety Pharmacist
Nurse manager
Charge nurse
Floor nurse

Data gathering.The next step during root cause analysis involves trying to
determine what happened. Part of this process requires reviewing physician
orders, pharmacy computer entries, and nursing records. Another part of this
process involves interviewing those individuals involved in the error. The
interviews are meant to determine what factors played a role in the error, not to
assign blame.
Methods and tools used.The team, in an effort to determine underlying
causes, developed a cause-and-effect diagram (Figure 1). Depending on the
error, the cause-and-effect diagram can include multiple processes. The
functions considered usually deal with:

Equipment/materials
Policies/procedures
Education/training
Communication/access to information

Figure 1. Example of a cause-and-effect diagram developed during root cause


analysis.

What the team discovered.

Prescribing physician was unfamiliar with dosing of intravenous colchicine


and obtained dosing information from a colleague.
No mention of toxicity was offered to the prescribing physician.
Prescribing physician was unaware of the drug information resources on
the patient care unit.
There was a 5-hour delay in faxing the order to the pharmacy.
The pharmacist questioned the lack of maximum dose on order.
Cross-cover MD was contacted by the pharmacist (prescribing MD no
longer available).
Pharmacist was told to contact the prescribing MD in the morning for a
discontinue order.
Cross-cover MD did not inform prescribing MD of the pharmacy call.
Pharmacist entered colchicine order into pharmacy computer system
without putting in a stop date.
Copy of incorrect order misplaced/lost; no follow up by pharmacist in the
morning.
RN was unaware of dosing toxicity with intravenous colchicine.
Patient received total of 9 mg.

A literature search to identify similar problems as well as possible solutions was

performed.
Actions takenGuidelines for the administration of intravenous colchicine were
developed and publicized for all health care professionals. The guidelines
specified a maximum single dose of 2 mg and total dose (course of therapy)
maximum of 4 mg. Dosing must be decreased in geriatric patients or in patients
with decreased renal function. Patients on hemodialysis should not receive the
drug.
Computer dosing maximums were implemented to limit the course of therapy to 4
mg. Subsequently, pharmacists could not enter a course of therapy in excess of
4 mg. Alerts for decreased renal function and age were also implemented.
Through a literature review, the team members discovered that intravenous
colchicine is rarely used todayless than 1% of patients treated for gout require
IV colchicine. Due to this lack of use and the high potential for dosing errors, the
drug was given "high-alert" status at the hospital. Use of this treatment was
discouraged, and clinicians were advised to use safer alternatives. If intravenous
colchicine was the only viable alternative, dosing restrictions were implemented
on its dispensing. Doses could only be dispensed from the pharmacy; stock was
prohibited in automated dispensing machines or on the floor. In order to follow
those patients placed on intravenous colchicine more closely, the pharmacy
department also updated its clinical monitoring drug search to include this
medication.
Some of the improvements implemented may require follow-up to ensure that the
processes are operating at an acceptable level. Determining which processes
need follow-up and who will be responsible for it, is an important part of root
cause analysis. For example, in this case, the pharmacy will need to implement
the proposed computer dosing limits. Testing must occur to ensure that the
computer adequately stops the order entry of excessive doses of colchicine. Part
of the process might include testing for a "work around," such as multiple course
entries on the same patient. Ongoing monitoring of usage may also need to be
assigned.
As demonstrated in the sample case, root cause analysis can be used to
determine how a system failed. The tools utilized in this root cause analysis can
be used to assess causes and possible solutions in pharmacy areas. Root cause
analysis is routinely used for serious errors, such as sentinel events, but it can
also be used to examine some of the more common and less severe errors.
TECHNOLOGY: PATHWAY TO ERROR REDUCTION?
Current attention to medication safety is focused on the technology aspect of
error reduction. Just what role technology will play in reducing medication errors
is still to be determined. Clearly, computer physician order entry (CPOE) and bar

coding will play a major role in upcoming years in health care error reduction
plans.
Computer Physician Order Entry
CPOE is a technology designed to decrease medication errors by improving the
prescribing aspect of the medication use system. Bates et al showed that 56% of
errors that resulted in preventable adverse drug events occurred during
prescribing.19 This would indicate that there is ample opportunity to improve this
aspect of the medication use system. Many of the dispensing problems
discussed earlier could be eliminated or reduced with CPOE. Legibility,
incomplete orders, and dangerous abbreviations could be virtually eliminated.
Implementing a CPOE system is a challenging assignment. Balancing the patient
safety features with ease of use for the clinician is an ongoing process. As with
any automated system, there is the ability to find a "work around." If the system is
too difficult for the physician to use, the quest for shortcuts occurs. Bypassing
alerts is another problem encountered with CPOE. When pharmacy systems
were implemented, one of the dangers of the allergy/drug interaction alerts were
that if they happened too often, the clinician would become desensitized and
bypass the alerts. Similar problems may occur with CPOE that could lead to
errors. Careful attention to establishing the alerts and developing a plan to follow
up on bypassed alerts should be considered when implementing this technology.
It is important to note that prescribing errors will still occur even if CPOE is
introduced.20 The possibility of selecting the wrong patient or wrong medication
still exists. Another study demonstrated that CPOE will do little to prevent
adverse drug events.21 The authors concluded that CPOE systems must
incorporate decision support for drug selection, dosing, and monitoring in order to
decrease preventable adverse drug events. Despite the problems noted here,
studies have demonstrated an 81% decrease in non-missed dose error rates
after implementing CPOE.22 Couple the demonstrated value of a CPOE system
with the large percentage of errors resulting from prescribing, and the push to
implement this technology is understandable.
Ambulatory care clinics and private physician's offices may have their own
version of physician order entry, often referred to as electronic prescribing or "Eprescribing." These physicians utilize computer programs to generate
prescriptions that are transmitted electronically to outpatient pharmacies. These
systems operate much like the CPOE systems found in hospitals, making
handwriting and illegible prescriptions a thing of the past. One problem
encountered with some of these systems occurs at the point of transmitting the
prescription to the pharmacy. If the system operates by generating a fax, when
the pharmacy fax machine is inoperative, busy, or the wrong fax number is used,
significant delays and duplication of efforts can result. In spite of these
inconveniences, E-prescribing has the potential to reduce errors and enhance
medication safety.
Bar Codes

Using machine-readable labeling (bar codes) and scanning is a technology that


can be utilized to reduce errors due to dispensing and administering. Bar coding
is not a new technology, just fairly new to health care. Individuals encounter bar
coding all the time in grocery stores. Clerks scan an item to be purchased, and
the name of the item as well as the price appear on the computer screen during
check out. This same technology can be applied to health care to minimize
medication errors. Patients admitted to the hospital would be given some type of
bar-coded identification, possibly an ID bracelet. When administering a
medication, the nurse would scan the patient's ID as well as the medication being
administered. A link to the hospitals computer system would enable the system
to match the drug to be administered with the prescribed medications on the
patient's profile. This would prevent the nurse from administering a wrong
medication or dose to the patient. In the study by Bates, he showed that 34% of
errors associated with preventable ADEs were errors of administration, and only
4% of errors were attributed to dispensing.19 Given the large percentage of errors
due to administration, bar coding is a technology that could have a big impact on
this part of the medication use process.
It is also important to point out that bar coding has a role in reducing errors
introduced during dispensing. Verifying the drug utilizing bar code technology
prior to dispensing can decrease the likelihood that an incorrect medication will
find its way into the patient's medicine cabinet.
One of the problems associated with bar coding is that many medication
packages lack a bar code. In February 2004, the FDA finalized a new rule, "Bar
Code Label Requirements for Human Drug Products and Blood," which requires
bar codes on all prescription and some over-the-counter drugs, blood, and
vaccines.23 The rule requires that the product bar code at least contain the
product's National Drug Code (NDC) number. The bar code technology could
potentially increase the interception of dispensing/administration errors by 50%.
The FDA estimates that bar coding will result in 500,000 fewer adverse events
over the next 20 years which could translate into cost savings that could
approach $93 billion (also over 20 years). Implementing mandatory bar coding is
not without cost, however. Estimates of the cost to the pharmaceutical industry
range between $500 million and $1.4 billion over 10 years.24 There is concern
that in order to avoid the additional costs resulting from bar coding,
pharmaceutical companies may decrease the number of medications available in
unit dose packaging. If hospitals must repackage such items and apply bar
codes, this could re-introduce error into the process and decrease the benefit of
the technology. Recognizing the importance of bar coding, many pharmaceutical
companies already bar code many of their products. For those hospitals utilizing
bar code technology, formulary or purchasing decisions may incorporate whether
a product has a bar code as part of the selection process.
How successful is bar coding? The IOM report cited work done at Comery-O'Neil
VA Medical Center in Topeka, Kansas where the hospital was able to reduce

medication errors by 70% over a 3-year period. This clearly demonstrates the big
impact this technology can have in an institution.1
RESOURCES FOR MEDICATION SAFETY PRACTICES
Much has been done in the patient safety arena both prior to and since the IOM
report. Best practices, safe medication practices, and error prevention strategies
are offered by a variety of different organizations (Table 7). ISMP stands out as
one of the premier organizations dedicated to preventing medication errors. Its
newsletters continually keep health care providers informed as to what
medication errors or problems are occurring and how best to prevent the errors.
The staff is available to answer questions and help solve medication error-related
problems. The medication safety self-assessment for hospitals and the selfassessment for community pharmacies are both great tools for "grading" how
your institution or pharmacy is performing. Regular visits to the ISMP web site
should be part of every pharmacist's routine.

Table 7. Organizations Offering Safe Medication Practices


Organization

Web Site

Institute for Safe


Medication
Practices (ISMP)

www.ismp.org

Features

Joint Commission
on Accreditation of
Healthcare
Organizations
(JCAHO)

www.jcaho.org

California Institute
for Health
Systems
Performance
(CIHSP)

www.cihsp.org

Medication safety alerts (Acute


care, Community/ambulatory care,
Consumer or Nursing versions)
newsletters aimed at patient safety
issues
Consults on medication error
problems (offers site visits)
Web site has frequently asked
questions section
Message board for asking
questions of other health
professionals
Self-assessment tool for hospitals
or one for community pharmacy
practice.
Education program
Sentinel event alerts and patient
safety newsletters are available
Identify underlying causes and
suggest steps for prevention
Provides a compendium of
suggested practices, an 86-page
document outlining strategies for
improving patient safety.

National
Coordinating
Council for
Medication Error
Reporting and
Prevention
(NCCMERP)

www.nccmerp.org

VA National
Center for Patient
Safety

www.patientsafety.gov

American Hospital
Association

www.aha.org

US Pharmacopeia
(USP)

www.usp.org

Med-E.R.R.S.

www.med-errs.com

American Society
of Health-system
Pharmacists
(ASHP)

www.ashp.org

Provides taxonomy for medication


errors (definitions of medication
errors, error types etc.)
Provides recommendations for
various process, such as bar
coding
Provides clear explanations of
commonly used QA tools (FMEA
and Root Cause Analysis)
TIPS topics in patient safety
Section devoted to quality and
patient safety
Successful Safety Practice
section with many pertinent articles
related to patient safety
Drug information on over 11,000
generic and brand name drugs
Practitioner reporting news that
includes examples of reported
medication errors.
On-line reporting mechanism for
medication errors.
Subsidiary of ISMP
Assists pharmaceutical companies
in evaluating labeling, packaging
and nomenclature for safety
Why include this for practitioners?
They can always use practitioner
participation in the review process,
visit the site and see what the
evaluation process is like.
Relatively new section on patient
safety
Extensive bibliography
Medication Use System Safety
Strategy

A California law has been passed requiring all hospitals to develop and submit a
plan to substantially reduce medication errors.25 In order to assist hospitals in this
undertaking, the California Institute for Health Systems Performance (CIHSP)
developed a compendium of suggested practices. Many of the sites listed in
Table 7 offer suggested practices or best practices. These sites can be used as a
resource in the search for error prevention strategies.

REPORTING MEDICATION ERRORS: WHY AND HOW?


Many of the advances that have occurred in health care are the result of
information obtained from practitioner reporting of medication errors. Hospitals
and hospital pharmacies have gathered data on medication errors for years, and
this same quality improvement practice is making its way into other health care
arenas. Community pharmacies should look to develop an error reporting
process so that weaknesses in their systems may be identified and corrected.
Reporting errors and performing root cause analyses to determine why systems
fail is the cornerstone of the quality improvement process. Tracking "near
misses" is also an important process to consider; these will also identify potential
system flaws that need correcting.
There are multiple voluntary reporting systems available. Error information from
one site can prevent a similar error at another site, if the information is made
available for all to review. There is current legislation under consideration that
would create one system for voluntary reporting of medical errors or near misses.
One such bill, The Patient Safety and Quality Improvement Act (HR 663)
provides for voluntary reporting as well as providing for an analysis of the error
reports. This is only one of several bills aimed at improving patient safety. Much
of the safety-related legislation is aimed at voluntary reporting, extension of
confidentiality, and peer review protection.3 One roadblock to reporting is the
fear of legal action and discoverability. An extension of confidentiality and peer
review protection will assist in alleviating this concern and increase error
reporting to national databases. Some of the national reporting processes (Table
8) available for health care providers include:

FDA Medwatch-Voluntary reporting of serious adverse events, potential or


actual medication product errors, and product quality issues; available to
all health care professionals;
USP Medication Errors Reporting Program-Voluntary reporting program
available to all health care professionals;
MedMARx-Internet accessible; performance improvement tool designed
for hospitals and health systems; anonymous reporting, fee to participate
(only participating hospitals can submit error reports into this database);
JCAHO Sentinel Event Hotline-Available for hospitals to report sentinel
events (reporting encouraged but not required); also asks for root cause
analysis submission in order to identify "lessons learned."

Table 8. National Error Reporting Programs


Web Site
FDA MedWatch

www.fda.gov/medwatch

Contact
Numbers
Phone:
800-FDA-1088
Fax: 800-FDA0178

Reporting
Available
Online
Phone
Fax
Mail

USP Medication
Errors Reporting
Program

www.usp.org/patientSafety/mer

MedMARx

www.medmarx.com

JCAHO Sentinel
Event Hotline

www.jcaho.org

Phone:
800-23-ERROR
Fax: 301-8168532

Online
Phone
Fax
Mail
Online
(Must be
subscriber)

Phone:
630-792-3700

PATIENT EDUCATION
No lesson on patient safety would be complete without a discussion of patient
education. A patient who is knowledgeable about his/her medication is much
more likely to avoid an adverse drug event resulting from a medication error.
Some safety tips to pass on to patients include:

Ask your physician the name of the medication he/she is prescribing, how
you are to take it, as well as what it is used for.
Bring all your medications to your appointments.
Ask for refills well in advance of running out.
Call your pharmacist to ask about any changes in your tablet size, color,
or appearance before taking.
Take your medications as directed by your physician.
Ask about drug interactions prior to taking a new prescription medication,
over-the-counter product, or nutritional/herbal supplement.
Always inform healthcare providers of any drug allergies.
Use one pharmacy to ensure that your complete drug history is always
available.

SUMMARY
Many different strategies to reduce medication errors have been discussed here.
It is important to note that very little evidence-based literature exists to evaluate
all of the patient safety practices discussed.26 Lack of hard scientific evidence
does not imply that safety practices that have not been "proven" should be
discarded. Changes that make sense are based on sound principals or
experience and should be pursued in the quest for error reduction. There are
multiple strategies available, high-tech and low-tech, to improve patient safety.
The assignment for health systems is to answer the question: "What strategies
and technologies can be implemented and how should that be done?" Finally, a
cooperative effort between healthcare providers, patients, pharmaceutical
companies, and the government may form the alliance that leads to enhanced
safe, effective medication use.

REFERENCES

1. Kohn KT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health
system. Washington , DC : National Academy Press; 1999.

2. Winterstein AG, Sauer BC, Hepler CD, Poole C. Preventable drug-related hospital
admissions. Ann Pharmacother. 2002;36(7-8):1238-1248.

3. Federal and state legislation addressing safety issues: what it means. Joint Commission
4.
5.
6.
7.
8.
9.
10.

11.
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18.
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21.
22.
23.

Perspectives on Patient Safety. 2003;3(2):1-4.


HIMSS State Legislation tracker. Available at:
http://himss.org/advocacy/news_tracker.asp
Allina Hospitals and Clinics. Medication safety contest winner: survey to solicit
information about the culture of reporting. Available at:
http://www.ismp.org/Tools/AllinaAssessment.html. Accessed September 25, 2005.
Cohen MR, ed. Medication Errors. Washington DC : American Pharmaceutical
Association; 1999.
Teichman PG, Caffee AE. Prescription writing to maximize patient safety. Fam Pract
Manag. 2002; 9(7):27-30.
JCAHO. National patient safety goals. Available at:
http://www.jcaho.org/accredited+organizations/patient+safety/npsg.htm. Accessed
September 25, 2005.
Lesar TS. Tenfold medication dose prescribing errors. Ann Pharmacother. 2002;
36(12):1833-1839.
JCAHO national patient safety goal list of sound-alike and look-alike medications.
Available at:
http://www.jcaho.org/accredited+organizations/patient+safety/05+npsg/lasa.pdf.
Accessed September 25, 2003.
JCAHO. Look-alike, sound-alike drug names. Sentinel Event Alert. 2001;19:1-4.
Kenagy JW, Stein GC. Naming, labeling, and packaging of pharmaceuticals. Am J
Health-Syst Pharm. 2001: 58(21):2033-2041.
ISMP. Medal Error Recognition and Revision Strategies, Inc. Available at:
http://www.med-errs.com/. Accessed September 25, 2005.
Grissinger M. Improving safety with verbal orders. P&T. 2001;26:626-627.
FDA Center for Drug Evaluation and Research. Name differentiation project. Available at:
http://www.fda.gov/cder/drug/MedErrors/nameDiff.htm. Accessed September 25, 2005.
Grasha AF. Tools for the reflective practitioner: using self-monitoring, personal feedback,
and goal setting to reduce error. Health Notes. 2002;1(6):19-24.
VA National Center for Patient Safety. Healthcare failure mode and effects analysis
course materials (HFMEA). Available at: http://www.patientsafety.gov/HFMEA.html.
Accessed September 25, 2005.
Joint Commission on Accreditation of Healthcare Organizations. Sentinel events:
evaluating cause and planning improvements. 1998.
Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential
adverse drug events; implications for prevention. ADE Prevention Study Group. JAMA.
1995; 274(1):29-34.
Koppel R, Metlay JP, Cohen A, et al. Role of Computerized Physician Order Entry
Systems in Facilitating Medication Errors. JAMA. 2005; 293(10): 1197-1203.
Nebeker MS, Hoffman JM, Weir CR, et al. High rates of adverse drug events in a highly
computerized hospital. Arch Intern Med. 2005;165:1111-1116.
Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a
team intervention on prevention of serious medication errors. JAMA. 1998; 280(15):13111316.
United States Food and Drug Administration. FDA proposes drug bar code regulation.

24.
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Available at: http://www.fda.gov/oc/initiatives/barcode-sadr/fs-barcode.html. Accessed


September 25, 2005.
Thompson CA. FDA to develop rules for mandatory bar-code labels. Am J Health-Syst
Pharm. 2002;59(2):107,112.
California Health and Safety code 1339.63. Available at: http://www.leginfo.ca.gov/
Accessed September 25, 2005.
Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidencebased medicine meets patient safety. JAMA. 2002;288(4):501-507.

QUESTIONS

1. The overall cost to treat hospitalized patients for preventable adverse drug events is
approximately:
a. $100 million
b. $500 million
c. $1 billion
d. $2 billion
e. $10 billion
2. All of the following will assist in successfully establishing a culture of safety
EXCEPT:
a. reward and encourage error reporting
b. focus on system problems
c. use error data to drive change and identify training opportunities
d. effect change by utilizing error reporting in performance evaluations
e. include multi-disciplinary approach to error prevention
3. Abbreviations considered to be problem-prone or "dangerous abbreviations" include:
a. mcg
b. QID
c. u
d. QOD
e. all of the above
4. Which of the following groups performs safety testing on drug names?
a. Med ERRS, Inc
b. JCAHO
c. American Hospital Association
d. ASHP
e. a and d
5. The FDA Office of Post-marketing Drug Risk Assessment was formed in:
a. 1995
b. 1997
c. 1999
d. 2000

e. 2002
6. Practical strategies to reduce errors resulting from sound-alike medications and verbal
orders include:
a. read back verbal orders
b. prohibit the use of all verbal orders
c. establish policies on who can receive verbal orders
d. a and c
e. b and c
7. Problems associated with receiving verbal orders include:
a. distracting noises
b. lack of attention by the health care provider
c. transcribing order into written format
d. ability to identify the prescriber
e. all of the above
8. The aspect of the medication use system that is most affected by look-alike errors is:
a. dispensing
b. prescribing
c. transcribing
d. administering
e. all of the above
9. One strategy to decrease prescribing errors associated with look-alike medications is
to:
a. store problem medications alphabetically
b. use only generic names on labels
c. avoid incorporating alerts in computer systems
d. include indication on prescription
e. none of the above
10. Which of the following strategies will significantly reduce errors associated with
packaging?
a. CPOE
b. bar coding
c. JCAHO inspections
d. a and b
e. none of the above
11. Which of the following factors has been shown to induce process errors?
a. high workload
b. low workload
c. shifting from high to low workload
d. a and c

e. b and c
12. Eye-level script holders resulted in a ______ reduction in reported process errors.
a. 5%
b. 15%
c. 20%
d. 25%
e. 30%
13. Certain medications are deemed high-alert because they:
a. are more error prone
b. can result in significant patient harm
c. are labeled as such by FDA
d. a and c
e. none of the above
14. JCAHO patient safety goals encourage hospitals to remove _______ from floor stock.
a. lidocaine
b. esmolol
c. concentrated electrolytes
d. all of the above
e. a and b
15. According to one study, 56% of errors resulting in preventable adverse drug reactions
occur during:
a. prescribing
b. transcribing
c. dispensing
d. administering
e. monitoring
16. By instituting CPOE, hospitals have demonstrated decreases in non-missed dose error
rates of:
a. 15%
b. 63%
c. 81%
d. 89%
e. 95%
17. The FDA proposed rule for bar coding will require pharmaceutical companies to
place bar codes on:
a. nutritional supplements
b. all over-the-counter products
c. vaccines and prescription items
d. blood products

e. c and d
18. Over 10 years, bar coding is estimated to cost pharmaceutical companies between:
a. $25-30 million
b. $300-400 million
c. $500 million-1.4 billion
d. $3-4 billion
e. over $4.5 billion
19. National error reporting processes available to all healthcare professionals include:
a. FDA MedWatch
b. USP practitioner reporting
c. MedMARx
d. a and b
e. all of the above
20. Proposed legislation, the Patient Safety and Quality Improvement Act, provides for:
a. voluntary reporting of errors
b. mandatory reporting or errors
c. analysis of error reports
d. a and c
e. b and c

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