Reducing Medication Errors Associated with At-risk

Behaviors by Healthcare Professionals

It is human nature to look for quicker and easier ways to accomplish tasks, but these actions may
lead to, or be a result of, at-risk behaviors. At-risk behaviors are actions taken by some healthcare
practitioners that could compromise patient safety. Those who engage in at-risk behaviors may do
so because the rewards are immediate and the risk of patient harm seems remote, making it
difficult to motivate people to always choose the safest way to work. As healthcare practitioners
become comfortable and competent with the tasks at hand, they may have a tendency to engage
in at-risk behaviors. These behaviors often result in convenience, comfort, and saved time. The
perceived benefits of taking shortcuts rapidly leads to continued at-risk behaviors, despite
practitioner's possible knowledge, on some level, that patient safety could be at risk. In addition,
as one practitioner has apparent success with an at-risk behavior, s/he will likely influence fellow
practitioners until that behavior becomes a standard practice. These behaviors often emerge
because of system-based problems and complexities in healthcare organizations.

Establishing an Organizational Culture to Help Minimize At-risk Behaviors

When patient harm occurs, an organization often focuses on the "sharp end" of the medication-use
process, such as at risk behaviors by the front-line practitioners that were linked to the event.
However, punishment based only on the outcome, when other instances of at-risk behavior by an
individual or group go unnoticed, can send the wrong signal to staff. These behaviors often
emerge because of system-based problems within healthcare organizations, for example, an
organizational culture with a high tolerance of at-risk behaviors. Unnecessary complexity in
processes also provides many opportunities for practitioners to take risks when providing care to a
patient.

The National Coordinating Council on Medication Error Reporting and Prevention makes the
following recommendations to reduce medication errors associated with at-risk behaviors:

1. Eliminate organizational tolerance of risk. Organizations, somewhere along the way, may
have tacitly approved or overlooked certain at-risk behaviors. Most organizations have
allowed these at-risk behaviors to grow because they have resulted in savings of time
and/or resources. To determine if the organization's culture is tolerant to at-risk behavior,
organizational leaders should ask themselves, "Does my organization tend to "punish" safe
behavior, and/or allow at-risk behavior?"ii.
2. Increase awareness of at-risk behaviors. To improve safety, it is more important to reduce
staff tolerance of at-risk behaviors than to increase their compliance with specific safety
rules. Organizations should start by enhancing staff awareness and reporting of at-risk
behaviors and analyzing error reports for common at-risk behaviors. For each at-risk
behavior, determine the corresponding safe behavior and the reasons why this behavior
was not followed
 3. Determine system-based reasons for risk taking behavior. Although it is commonly
believed that one of the easiest ways to control behavior is to create a policy and discipline
individuals who breach it, this strategy does not uncover the system-based reason that
may lead to these breaches. The better approach is to uncover the system-based reasons
that lead people’s need to engage in these at-risk behaviors and to decrease staff
tolerance for taking risks.
4. Eliminate system-wide incentives for at-risk behaviors. The most important step, after
identifying at-risk behaviors, is to uncover and reverse consequences that lead staff to
believe the positive rewards for at-risk behaviors outweigh any perceived drawbacks of the
corresponding safe behaviors. Organizations must identify those undesirable
consequences that can be reduced or eliminated. These may include partial or ineffectual
use of technology designed to alleviate risks . Facilities can employ a collaborative
approach with clinical leadership, Human Resources, and risk management to assure
proactive performance review is occurring and there are multiple mechanisms in place for
employees to report concerning behaviors. Such a collaborative approach can also identify
and communicate triggers that might suggest the need of further investigation of
behaviors.
5. Motivate through feedback and rewards. Align individual and group motivation to avoid at-
risk behaviors. Often, staff may believe that the organization's priority is efficiency and
productivity. Ask staff to document one at-risk behavior and one safe behavior each day,
along with the conditions under which these behaviors occurred. Collect and group these
behaviors into categories of circumstances that lead to at-risk behaviors. These
circumstances should be reviewed and acted upon by multidisciplinary committees at each
organization. The safe way to do something must be reinforced with staff as a component
of an uncompromised value system. Support, encouragement, and recognition/reward
programs for all who meet behavioral criteria must be ongoing.
6. Involve patients and families in the processes of safe medication administration and
monitoring. Patients do better when they have a say in their own care. Patients should be
able to ask questions about the medication to be administered, method of administration
and expected outcome of use including side effects. Staff are less likely to engage in at
risk behavior when patients and their families take an active role in managing their care.

At-risk behaviors may include the following:

I. Patient Information

1. Not checking patient identification using two identifiers (e.g., name, medical record
number, birth date)
2. Not checking a patient's allergies before prescribing/dispensing/administering medications
3. Not viewing/checking the patient's complete medication profile (or medication
administration record [MAR]) prior to prescribing/dispensing/administering medications
II. Drug Information

1. Prescribing/dispensing/administering medications without complete knowledge of the

medication
2. Unnecessary use of manual calculations
3. Not questioning unusually large doses of medications
4. Failure to visually inspect the medication to be administered
5. Failing to validate/reconcile the medications and doses that the patient states are taken at
home

III. Communication

1. Rushed communication with next shift/covering colleague

2. Intimidation/not speaking up when there is a question or concern about a medication
3. Use of error-prone abbreviations/apothecary designations/dangerous dose designations
[noted less often]
4. Unnecessary use of verbal orders [noted less often]
5. Not reading back verbal orders [noted less often]

IV. Labeling, Packaging, Nomenclature

1. Absent or poor labeling of syringes, solutions, and/or other medication packages

2. Grab and go without fully reading the label of a medication before
dispensing/administering/restocking medications
3. Storing medications with look-alike, sound-alike labels and packaging beside one another

V. Drug Stock, Storage, Distribution

1. Leaving medications in an unlocked storage area

2. Preparing IV admixtures outside of the pharmacy

VI. Environment/Staffing Patterns

1. Managing multiple priorities while carrying out complex processes (e.g., order entry,
transcription, drug administration, IV admixture)
2. Holding/admitting overflow patients in inappropriate units/areas
3. Failure to adequately supervise/orient staff
4. Inadequate staffing based on patient acuity

VII. Patient Education

1. Prescribing/Administering/Dispensing medications without educating patient

 2. Disregarding patient's/caregivers concerns about a medication's appearance, reactions,
side effects, or other expressed worry
3. Failure to follow up regarding a medication’s intended effect against the patient’s observed
or reported effect.

VIII. Staff Education

1. Inadequate orientation of new/agency staff

2. No organizational incentives to achieve certification or attend continuing education
3. Lack of a structured and ongoing staff competency program related to medication use

IX. Quality/Culture

1. Sacrificing safety for timeliness

2. Failure to report and share error information
3. Organizational culture of secrecy rather than openness about medication errors
4. Organizational culture of finger pointing rather than system change
5. Failure to address interruptions during medication ordering, preparation, and administration
6. Failure to properly implement and evaluate new technology

X. Double Checks

1. Failure to ask a colleague to double check manual calculations before proceeding

2. Failure to ask a colleague to double check high alert medications before
dispensing/administration
3. Failure to ask a colleague to double check high risk processes (e.g., patient controlled
analgesia) before proceeding

XI. Teamwork

1. Reluctance to consult others or ask for help when indicated

2. Lack of responsiveness to colleague/patient requests

XII. Technology

1. Technology work-arounds
2. Overriding computer alerts without due consideration
3. Failure to fully engage available technology
 FACTORS
CONTRIBUTING
TO MEDICATION
ERRORS
Introduction
It is perhaps taken for granted that all nurses who undertake medicines
administration have been adequately trained for this aspect of their role. However,
Hughes (2004) suggested that human factors such as lack of experience or skill
predispose people to errors. Several studies have identified nurses’ poor
mathematical competency as a key element of medication administration errors
(Lee, 2008; Wright, 2007; Grandell-Niemi et al, 2003).
The National Patient Safety Agency (NPSA) (2007) reported that the most common
types of error are those involving incorrect dosage, frequency and strength. These
account for 29% of all reported errors. The NPSA said it is crucial that these issues
are addressed as they can result in severe harm or death.
Yet evidence demonstrates that qualified nurses do not necessarily have the
appropriate knowledge and skills to accurately calculate drug doses (Wright, 2007).
Pape (2003) supported this, reporting that most medication errors occur at the
point of administration, and that administration errors rank third in the list of
causes leading to loss of function or patient death. Kohn et al (2000) argued that
while some errors can be prevented, it is unlikely they will ever be eliminated as
they arise from human nature.
This has implications for nurse educators and student nurses. In general terms,
curricula need to be developed to address these issues. In the clinical setting,
student nurses administer medication under the supervision of qualified nurses.
Part of the NMC’s (2008b) remit is to ensure that students demonstrate fitness for
practice before being included on the register as qualified nurses.
The NMC (2004) developed standards to support learning and assessment and
these take the form of a developmental framework. These proficiency standards are
the bedrock of current first level nurse education programmes including medicines
administration.
Wright (2007) found that student nurses are often not able to conceptualise the
theoretical knowledge of medicines administration to the practical setting. The
ability to calculate accurately the number of tablets is a routine aspect of nursing
practice.
A significant shift in educational provision has occurred to achieve the NMC
proficiencies. For example, student nurses at the University of Wolverhampton are
now assessed for medicines administration summatively in the clinical area, using
an essential skills cluster booklet to enable them to link theory to practice.
Therefore, it is important that continued efforts are made in pre and post
registration education, in collaboration with clinical practice, to develop and
promote qualified and student nurses’ mathematical and medicines administration
skills to enhance competence in this area.

Literature review
Medicinesadministration is often viewed as a basic nursing task, when in fact it
requires complex interaction of a large number of specific decisions and actions,
often performed under less ideal conditions in clinical practice. This complex
administration process increases the potential for errors. Conducting this literature
review has highlighted a lack of empirical research on nurses’ views of the factors
that contribute to medicine administration errors.
Weeks et al (2000) conducted a study looking at written drug dosage errors made
by nursing students and described the mathematical competence necessary for safe
calculation of medication dosages. They concluded there is a need for new
approaches to teaching and assessment of medicines administration.
Clearly, the development of such skills cannot be left to chance and, as such,
teaching programmes should be designed to allow for student nurses’ differing
capabilities. This could involve the use of computer based learning activities
alongside simulated practical sessions in the skills laboratory. Hutton (1998)
supported the use of clinical skills areas as useful in enhancing students’ knowledge
by applying mathematical knowledge to clinical practice.
Kelly and Colby (2003) carried out a study addressing problem based learning as an
approach to improving drug calculation skills. Nursing students were given drug
calculation problems to solve and allowed to work out their own methods of solving
the calculations. The study has had some success in encouraging student nurses to
acknowledge when answers obtained are not correct and identified that students
were able to conceptualise mathematical calculations in clinical practice. Other
studies have supported this, promoting the need for strategies on conceptualising
information from clinical practice into drug calculations (Wilson, 2003; Leathard,
2001; Weeks et al, 2000). Table 1 shows a worked example of using information
from the clinical setting in a drug calculation.
Table 1. Worked example

Drug Calculation

Name: Type Available as 240mg per 5ml syrup

Paracetamol Analgesic Dose required x volume

Dose available

Route Dose 500 x 5 =10.5ml

Oral 500 milligrams 240

A critique by Wright (2007) examined the way in which drug calculations are
currently taught, and suggested that the widely taught formula of “what you want,
divided by what you have, multiplied by what it is in” removes the clinical context
and translates into meaningless mathematical problems, relying on students having
the ability to manipulate numbers. To perform accurate drug calculations, Wright
(2004) suggested that two skills are required. First, student nurses need to have
basic mathematical skills to calculate accurately the equation given and second,
they need to be able to conceptualise clinical information presented to extract
relevant information to solve a calculation.
Fry (2007) conducted a cross sectional survey to establish the views of nurses in
the medical directorate of a large teaching hospital on a list of factors that
potentially contributed to medication errors, and explored personal and professional
views of reporting these incidents. The sample size was 244 registered nurses
employed permanently in 15 medical wards.
The contributing factors highlighted for medication errors were: distractions in the
environment; training and education; medication products and packaging; and
inability to read the drug chart. Out of 136 respondents, 33% revealed they had
been involved in a medication incident or error. One significant finding was that
higher bands of nurses were identified as having made the most errors.
Reason (2000) suggested that distractions can be a contributing factor in
medication errors, as identified in this particular study. In the clinical setting senior
nurses have greater responsibility and may have to carry out several clinical
and managementtasks simultaneously, such as carrying out the drug round,
supervising students and responding to telephone calls. These have to be carried
out irrespective of staffing levels and the type of ward.
Other literature repeatedly emphasises that diligent, competent healthcare
professionals make mistakes intermittently and even more so when activity
increases (Rex et al, 2000). Errors can occur due to multiple factors such as the
complexity of the healthcare system that nurses work in.
Rogers et al (2004), in a national survey of nurses using self report questionnaires,
found the risks of making an error increased significantly when registered nurses
worked shifts longer than 12 hours or more than 40 hours per week. The study
revealed that working overtime increased the odds of making at least one error,
regardless of how long the shift was originally scheduled. Although this research
also involved procedural, transcription and charting errors, of the 199 errors and
213 near errors, more than half the errors (58%) and near errors (56%) involved
medicines administration. The relationship of errors or near errors and hours
worked including overtime were not affected by age, type of hospital unit or size of
hospital.
Rogers et al’s (2004) study suggested a link between poor working conditions and
threats to patient safety. These factors demonstrate Reason’s (2000; 1990) theory,
whereby fatigue and understaffing must be considered as latent conditions.
Carlton and Blegen (2007) discussed latent failures and argued they involve two
kinds of situations: those that provoke conditions in the workplace, such as time
pressure, understaffing, inadequate equipment, fatigue and inexperience, and those
that are long lasting conditions, such as untrustworthy alarms and unworkable
 procedures. These deficiencies can lie undetected for several years before they
come to light, usually by a culmination of errors.
Whitman et al (2002) suggested that increased activity in the clinical area raises
the risk of medication errors. They suggested that clinical areas with patients who
are more seriously ill and have more complex medication regimens influence
medication errors. The most frequent types of errors in this study (dosage and
time) suggest time pressures and use of inadequate equipment as causes. For
example, infusion pumps used to administer IV medication are often left in
cupboards for long periods of time, not charged electrically and not serviced yearly,
which can cause dosage errors. Reason (2000) identified these reasons as error
provoking latent conditions that could lead to multiple errors if the situation is not
acknowledged and acted on.

Discussion
The literature review clearly identified a number of contributing factors to why
medicines administration errors occur, and this needs to be addressed. It must be
acknowledged that clinical nurses often have little control over contributing factors.
In clinical practice, a competency framework for medicines administration is now
used in most NHS trusts. The Department of Health (2004) introduced the
knowledge and skills framework. The KSF is a developmental review process
designed to:
 Identify the knowledge and skills that individual practitioners need to apply in their post;
 Help guide the individual’s development;
 Provide a fair and objective framework on which to base review and development for all
staff.
This should be a partnership between management and staff. We argue that
medicines administration should be part of this process. This particular tool may
prove useful in enhancing staff nurses’ knowledge and ability to improve skills in
mathematics and medicines administration. This will lead to improved qualityof care
for patients and may see a reduction in medication errors.
The new role of practice placement coordinator has been developed within schools
of health in higher education institutions. Part of the role involves supporting staff
and students in the clinical setting to improve the theory-practice gap.
Widening participation has become a general policy in higher education and as a
result, students’ educational attainment at entry varies considerably. This has led to
students entering nurse training courses with different qualifications, such as NVQ
at level 3 and GCSEs.
One consequence and challenge for universities is students’ mixed ability. Before
widening participation, prospective student nurses were required to have the
minimum of GCSE grade C mathematics to gain entry onto nurse training
programmes. Quite rightly, most universities have embraced the concept of
widening participation. Nonetheless, it is imperative that student nurses’
mathematical skills are developed for them to be able to safely calculate and
administer medication.

Future implications
As nurse educators, our duty is to develop a curriculum that reflects both theory
and practice to enable student nurses to become competent in medicines
calculation and administration. This also applies to practice mentors who have the
responsibility to help students in linking theory to practice in the clinical setting. In
the School of Health, drug calculation workshops have been used as a way of
improving student nurses’ knowledge and skills.
Other ways in which learning could be enhanced are by using simulated and
blended learning. Koper (2005) supported simulated learning and saw it as
essential to build the required competence in an effective way. Simulated learning
therefore takes place in the clinical skills laboratory, where students have the
opportunity to complete medicines administration. Blended learning offers student
nurses a combination of face to face and online learning (Rooney, 2003). With this
in mind, the five Rs (right person, right drug, right dose, right route, and right
time) have been introduced into the nursing curriculum, adapted from Cohen
(2003).
Qualified nurses are accountable for their actions and omissions in accordance with
the NMC (2008b) code of conduct. The onus is on the individual to keep updated
with the issues that are pertinent to medicines administration. If individual staff
nurses recognise they are not competent in this area, they should seek help to
increase competence and knowledge. The DH (2004) advocated a blame free
culture in which it is possible to learn from mistakes.
There is a clear need to develop strategies to enable qualified and student nurses to
calculate accurately and administer medication safely. The NMC (2008b) stipulated
that nurses have a duty of care to patients and no acts or omissions should lead to
any harm. Within the nursing curriculum medicines administration needs to be
included throughout the three years of the programme. Students need to access a
range of resources that should be available in written form and also online.
Medicines administration and calculation workshops should be held regularly and
these should be made mandatory for student nurses. Using the clinical skills
laboratory would help students in relating theory to practice situations if
opportunities for simulated learning are provided.
Some trusts have introduced regular mandatory updates and drug tests with pass
marks for qualified nurses as a way to improve skills and knowledge of medicines
administration.

Conclusion
In conducting this review, it became evident that UK nurses’ views on the
contributing factors in medication error have not been explored in great depth.
Most studies were carried out in the US and New Zealand. There is a need for
further empirical research in the UK to ascertain nurses’ views, as currently their
experiences and knowledge appear to be undervalued. Ideally, nurses should carry
out this research as they have a better understanding of today’s complex
healthcare environment and the pressures and challenges they face on a day-to-
day basis.
The review has identified a number of factors that increase the potential for
medication errors in practice, and these need to be addressed in the clinical setting.
Nurse educators also need to consider issues around patient safety and medicines
administration, and take steps to tackle these in the curriculum.
 NURSE
PRACTICE ACTS
AND
STANDARDS OF CARE
 Standards for Acute and Critical Care Nursing Practice
In 1998, the AACN Board of Directors formed a Practice Standards Task Force to evaluate and
revise the current standards. In support of the American Nurses Association's (ANA) position that
specialty standards should be framed from the general clinical nursing practice standards, the
AACN Practice Standards Task Force used the latest edition of the ANA Standards of Clinical
Nursing Practice as a template for its work. The Task Force evaluated each Standard of Care and
Standard of Professional Performance for its relevance to and inclusion of acute and critical care
nursing competencies. The original standards statements were either unchanged or revised to
better articulate the professional expectations of competent acute and critical care nursing
practice. The measurement criteria, which detail how nurses meet each standard, were
evaluated and revised as necessary to reflect the unique aspects of acute and critical care
nursing. These Standards for Acute and Critical Care Nursing Practice also reflect the key
concepts of the AACN Mission, Vision, Values, and Ethic of Care, scope of practice, and the
Synergy Model.

What Are Standards?

Clinical nursing practice can vary considerably depending on the setting in which the nurse is
employed and the patients cared for in that setting. The Standards for Acute and Critical Care
Nursing Practice describe the practice of the nurse who cares for an acutely or critically ill patient
no matter where that patient is cared for within the healthcare environment.

The Standards for Acute and Critical Care Nursing Practice

 are defined as authoritative statements that describe a level of care or performance common
to the profession of nursing by which the quality of nursing practice can be judged.
 are written to establish an example of the roles and responsibilities expected of the
practitioner by the profession at large.
 include both standards of care, which prescribe a competent level of nursing practice, and
standards of professional performance, which articulate the roles and behaviors expected of
nursing professionals.

Standards of Care for Acute and Critical Care Nursing

Standard of Care I: Assessment
THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS COLLECTS RELEVANT PATIENT
HEALTH DATA.

Measurement Criteria
1. Data collection involves the patient, family, and other healthcare providers as appropriate to
develop a holistic picture of the patient's needs.
2. The priority of data collection activities is driven by the patient's immediate condition and/or
anticipated needs.
3. Pertinent data are collected using appropriate assessment techniques and instruments.
4. Data are documented in a retrievable form.
5. Data collection process is systematic and ongoing.
Standard of Care II: Diagnosis
THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS ANALYZES THE ASSESSMENT
DATA IN DETERMINING DIAGNOSES.

Measurement Criteria
1. Diagnoses are derived from the assessment data.
2. Diagnoses are validated throughout the nursing interactions with the team consisting of the
patient, family, and other healthcare providers, when possible and appropriate.
3. Diagnoses are prioritized and documented in a manner that facilitates determining expected
outcomes and developing a plan of care.
4. Diagnoses are documented in a retrievable form.

Standard of Care III: Outcome Identification

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS IDENTIFIES INDIVIDUALIZED,
EXPECTED OUTCOMES FOR THE PATIENT.

Measurement Criteria
1. Outcomes are derived from actual or potential diagnoses.
2. Outcomes are mutually formulated with the patient, family, and other health care providers,
when possible and appropriate.
3. Outcomes are individualized in that they are culturally appropriate and realistic in relation to
the patient's age and present and potential capabilities.
4. Outcomes are attainable in relation to resources available to the patient.
5. Outcomes are measurable and should include a time estimate for attainment, if possible.
6. Outcomes provide direction for continuity of care so that the nurse's competencies are
matched with the patient's needs.
7. Outcomes are documented in a retrievable form.

Standard of Care IV: Planning

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS DEVELOPS A PLAN OF CARE
THAT PRESCRIBES INTERVENTIONS TO ATTAIN EXPECTED OUTCOMES.

Measurement Criteria
1. The plan is individualized to reflect the patient's characteristics and needs.
2. The plan is developed collaboratively with the team, consisting of the patient, family, and
healthcare providers, in a way that promotes each member's contribution toward achieving
expected outcomes.
3. The plan reflects current acute and critical care nursing practice.
4. The plan provides for continuity of care.
5. Priorities for care are established.
6. The plan is documented to promote continuity of care.

Standard of Care V: Implementation

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS IMPLEMENTS INTERVENTIONS
IDENTIFIED IN THE PLAN OF CARE.

Measurement Criteria
1. Interventions are delivered in a manner that minimizes complications and life-threatening
situations.
2. The patient and family participate in implementing the plan of care based upon their ability to
participate in and make decisions regarding care.
3. Interventions are documented in a retrievable manner.

Standard of Care VI: Evaluation

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS EVALUATES THE PATIENT'S
PROGRESS TOWARD ATTAINING EXPECTED OUTCOMES.

Measurement Criteria
1. Evaluation is systematic, ongoing, and criterion-based.
2. The team consisting of patient, family, and healthcare providers is involved in the evaluation
process as appropriate.
3. Evaluation occurs within an appropriate time frame after interventions are initiated.
4. Ongoing assessment data are used to revise the diagnoses, outcomes, and plan of care as
needed.
5. Revisions in diagnoses, outcomes, and plan of care are documented.
6. The effectiveness of interventions is evaluated in relation to outcomes.
7. The patient's responses to interventions are documented.

Standards of Professional Practice for Acute and Critical Care Nursing

Standard of Professional Practice I: Quality of Care
THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS SYSTEMATICALLY EVALUATES
THE QUALITY AND EFFECTIVENESS OF NURSING PRACTICE.

Measurement Criteria
1. The nurse participates in quality of care activities.
2. The nurse uses the results of quality of care activities to initiate changes in nursing practices
and the healthcare delivery system as appropriate.
3. The nurse assures that quality of care activities incorporate the patient and family's
perspective as appropriate.

Standard of Professional Practice II: Individual Practice Evaluation

THE PRACTICE OF THE NURSE CARING FOR ACUTELY AND CRITICALLY ILL PATIENTS REFLECTS
KNOWLEDGE OF CURRENT PROFESSIONAL PRACTICE STANDARDS, LAWS, AND REGULATIONS.

Measurement Criteria
1. The nurse evaluates his or her own nursing practice in relation to the professional practice
standards and relevant statutes and regulations.
2. The nurse engages in a self-assessment and/or a formal performance appraisal on a regular
basis, identifying areas of strength as well as areas where professional development would be
beneficial.
3. The nurse seeks and reflects on constructive feedback from the team consisting of patient,
family, and other healthcare providers regarding his or her own practice.
4. The nurse takes action to achieve performance goals.
Standard of Professional Practice III: Education
THE NURSE ACQUIRES AND MAINTAINS CURRENT KNOWLEDGE AND COMPETENCY IN THE CARE
OF ACUTE OR CRITICALLY ILL PATIENTS.

Measurement Criteria
1. The nurse participates in ongoing educational activities to acquire knowledge and skills needed
to care for acute and critically ill patients.
2. The nurse seeks experiences that reflect current clinical practice in order to maintain current
clinical skills and competencies needed to care for acutely and critically ill patients.
3. The nurse participates in ongoing educational activities related to professional issues.

Standard of Professional Practice IV: Collegiality

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS INTERACTS WITH AND
CONTRIBUTES TO THE PROFESSIONAL DEVELOPMENT OF PEERS AND OTHER HEALTHCARE
PROVIDERS AS COLLEAGUES.

Measurement Criteria
1. The nurse shares knowledge, skills, and experiences with colleagues.
2. The nurse provides peers and other healthcare providers with constructive feedback regarding
their practice, as appropriate to their level of expertise.
3. The nurse interacts with colleagues to enhance his or her own professional nursing practice.
4. The nurse contributes to a learning environment that is conducive to healthcare education.
5. The nurse contributes to an effective team environment by working with others in a way that
promotes and encourages each person's contribution.

Standard of Professional Practice V: Ethics

THE NURSE'S DECISION AND ACTIONS ON BEHALF OF ACUTELY AND CRITICALLY ILL PATIENTS
ARE DETERMINED IN AN ETHICAL MANNER.

Measurement Criteria
1. The nurse's practice is guided by the ANA's Code for Nurses, AACN's Ethic of Care, and ethical
principles.
2. The nurse maintains patient confidentiality within legal and regulatory parameters.
3. The nurse acts as a patient advocate and assists others in developing skills so they can
advocate for themselves.
4. The nurse delivers care in a nonjudgmental and nondiscriminatory manner that is sensitive to
patient diversity.
5. The nurse delivers care in a manner that meets the diverse needs and strengths of the patient
and preserves patient autonomy, dignity, and rights.
6. The nurse uses available resources in formulating ethical decisions.

Standard of Professional Practice VI: Collaboration

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS COLLABORATES WITH THE
TEAM, CONSISTING OF PATIENT, FAMILY, AND HEALTHCARE PROVIDERS, IN PROVIDING
PATIENT CARE IN A HEALING, HUMANE, AND CARING ENVIRONMENT.

Measurement Criteria
1. The nurse communicates with the team regarding patient care and the nurse's role in
providing care.
2. The nurse works with the team to formulate the plan of care and to make decisions related to
the care and delivery of services.
3. The nurse consults with other healthcare providers and initiates referrals as appropriate to
promote continuity of care.

Standard of Professional Practice VII: Research

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS USES CLINICAL INQUIRY IN
PRACTICE.

Measurement Criteria
The nurse continually questions and evaluates practice and uses best available evidence or
research findings to develop appropriate plans of care. The nurse participates in activities to
support clinical inquiry appropriate to the nurse's level of expertise.

Standard VIII: Resource Utilization

THE NURSE CARING FOR ACUTE AND CRITICALLY ILL PATIENTS CONSIDERS FACTORS RELATED
TO SAFETY, EFFECTIVENESS, AND COST IN PLANNING AND DELIVERING PATIENT CARE.

Measurement Criteria
1. The nurse evaluates factors related to safety, effectiveness, availability, and cost when
choosing between two or more practice options that would result in the same expected outcome.
2. The nurse assists the patient and family in identifying and securing appropriate and available
services to address health-related needs.
3. The nurse assigns or delegates aspects of care as defined by the state nurse practice acts.
4. If the nurse assigns or delegates aspects of care, the decision is based upon an assessment of
the needs and condition of the patient, the potential for harm, the stability of the patient's
condition, the predictability of the outcome, and the competencies of the healthcare provider.
5. The nurse assists the patient and family in becoming informed consumers about costs, risks,
and benefits of treatment and care.
 IMPACT
OF
MEDICATION
ERRORS
 A medication error is not the same as an adverse drug reaction, although the two may overlap.
Ferner and Aronson have defined a medication error as ‘a failure in the treatment process that
leads to, or has the potential to lead to, harm to the patient’[1]. They identified four different
scenarios: adverse drug reactions that arise from medication errors; adverse drug reactions that
do not arise from errors; medication errors that cause harms that are not adverse drug reactions;
and medication errors that do not cause adverse events. From the point of view of most patients,
the first three scenarios are indistinguishable, as they all refer to harms associated with the use of
medications. In addition, the language used by professionals may differ from that used by
patients, for whom the term ‘side-effect’ generally serves as a generic descriptor, even though,
technically, a side-effect is only one type of adverse drug reaction [2]. Furthermore, patients may
not appreciate that not all adverse events are due to adverse drug reactions. Here I shall use the
term ‘adverse effects’ when taking the doctor's perspective and ‘side-effects’ when taking the
patient's.

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The challenge for the patient

Clearly, the people who experience any harm or suffering resulting from medication errors are
the patients and possibly also their relatives and carers. Patients and their spouses or carers will
in many cases be the first to notice any observable problem that arises from a medication error.
In some cases, adverse events are immediate or well known. However, other events may be
delayed or unfamiliar and patients may not realize that the problem has anything to do with the
medication they are taking. The challenge for patients includes the perception, interpretation, and
attribution of any medication-related problems.

Different people are more or less sensitive to physical symptoms. The correct interpretation and
attribution of any symptoms have to compete with a variety of alternative explanations, including
symptoms of the underlying disease; normal wear and tear; extraneous factors, such as stressful
life events; and problems caused by other medications for those taking multiple medications. We
know very little about how people make attributions of medication-related problems. DeWitt and
Sorofman investigated the cognitive models used for patients' understandings of side-effects of
drugs, by comparing them with the prototype used for understanding illness [3]. They defined a
prototype as a cognitive approach that is simple and yields reliable classification of new cases. In
their questionnaire-based study of 338 adults attending a family medicine clinic in the USA, 53%
of the respondents reported personal experience of a side-effect. In their qualitative and
quantitative responses, the elements of the respondents' side-effects prototype were identical to
those of their illness perception prototype: cause, symptom, time, consequence, and cure. In their
narrative descriptions, nearly half (44%) of those who reported an adverse drug reaction
mentioned the cause of the reaction by naming the implicated drug or drug family. When asked
directly, 94% provided the name of a drug or drug class. In relation to the other elements, 98% of
respondents described symptoms, 10% gave information about the time of onset or duration,
24% described the consequences in terms of stopping taking the drug or other responses, and 3%
mentioned a cure. There was virtually no other information in people's narrative descriptions
beyond these five elements. People with previous experience of a side-effect believed that side-
effects in general were less severe than those without such previous experience. Those with more
formal education believed side-effects to be less severe than less educated respondents.

Other studies have shown that some people carry out their own evaluations of prescribed
medicines, to see if the medicines are working and to assess their impact on their daily lives [4].
These evaluations include weighing up the perceived costs and benefits of medications and
responding to perceived side-effects. They may confirm or disconfirm people's initial attributions
of medication-related effects; if the patient considers the attribution to have been confirmed, they
may decide to stop taking the medication.

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Quality of patients' reports

Professionals may have doubts about the quality of patients' reports of what they perceive to be
side-effects. However, in general such doubts are not supported by the available evidence. In a
questionnaire study of 837 patients for whom nine recently marketed ‘black triangle’ drugs had
been prescribed, Jarernsiripornkul et al. asked respondents to identify any symptoms they
thought could have been due to the drugs [5]. They then classified these symptoms according to
the probability that each symptom was caused by the index drug, using the literature on adverse
drug reactions. Nearly three-quarters (71%) of the symptoms were classified as being probably
or possibly related to the drugs studied.

In their review of patient reporting of suspected adverse drug reactions, Blenkinsopp et al.
concluded that there was some evidence that patient and professional reports are of similar
quality [6].

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Communication

Patients who, however tentatively, attribute their symptoms to their medicines may be deterred
from saying anything, for fear of seeming critical of the prescriber. Jarernsiripornkul et al. found
that only 54% of patients who identified potential side-effects had reported some or all of them
to their doctor [5]. In the subsample of 344 patients for whom tramadol had been prescribed, the
patients who perceived the most bothersome symptoms as being severe were also significantly
more likely to have informed their doctors than those who perceived the symptoms as being mild
[7]. Of the symptoms that patients who had used tramadol or venlafaxine claimed to have
reported, only 23% were documented in their primary-care records [5].

Without the expectation that their fears will at least be listened to and taken seriously, patients
may decide to say nothing, even if they have stopped taking the drug as a result. If the patient
remains silent, this is likely to lead the prescriber to conclude that there are no problems and that
the medicine can safely be prescribed again. If the patient does say something, however
tentative, and their attribution is correct or at least plausible, this may make the prescriber feel
guilty. Either way, the consultation may not include an unemotional and objective consideration
of the facts and what needs to be done.

Some studies have measured the extent to which patients mention side-effects in consultations
with doctors, with varying results. Sleath et al. videotaped consultations between 467 patients
with chronic conditions and their primary-care physicians; they found that only 9% made a
complaint about side-effects [8]. Patients were significantly more likely to make a complaint (not
just about side-effects) if they were asked more medication questions by their doctor. White and
Sander conducted a postal survey of 604 adults with asthma and the parents of 1230 children
with asthma, and found that 66% of the adults and 61% of the children had had side-effects of
medications [9]. Of these, 72% of the adults and 82% of the children claimed to have mentioned
side-effects to their doctors.

In their systematic review of communication between patients and healthcare professionals about
medicines, Cox et al. concluded that patients were more likely to express concerns if their doctor
asked them more questions, if they used more medicines, if they perceived their health to be
poor, or if their doctor was younger [10]. Doctors responded to patients' complaints about
medicines in a variety of ways: by changing the medicine; by providing education; by telling
patients that the benefits outweighed the harms; by saying that there were no alternatives or that
adverse effects were to be expected. In one study, doctors ignored patients' medication
complaints in >25% of cases [8].

Patients require information to help them make correct attributions and differentiate between an
error, a side-effect, the drug's normal therapeutic action, and the symptoms of their underlying
condition(s), if any. Although it is true that not all patients want information, the literature
suggests that patients want more information than they receive about adverse effects, and that
doctors tend to underestimate the extent to which patients want this information. In a study of
344 patients with rheumatoid arthritis, significantly more patients wanted information than
wanted to be involved in making decisions [11]. In their review of written information about
medicines, Raynor et al. also found that most patients wanted to know about side-effects, but that
professionals were sometimes reluctant to provide this information [12]. Some professionals felt
that the purpose of written information was to improve adherence.
In a study of 271 general practice patients, Makoul et al. compared patients' and doctors'
questionnaire responses with videotapes of the consultations [13]. Patients reported that doctors
provided the majority of the information they received about prescription medicines. Doctors
rated the importance of explaining all the risks of any medication as a mean 6 out of 10, but the
video analysis showed that risks were discussed in only 3.1% of consultations analysed.

Although professionals may find it difficult, and may judge that some patients do not have the
ability to comprehend information about the risk of adverse effects, the problem should not be
ignored. The challenge for professionals, as in the communication of all information about risks,
is to judge how much information an individual patient actually wants and is able to
comprehend. One way of opening this up is to ask the patient what they already know and how
much they want to know. In general, risk communication should be a two-way process, in which
professionals and patients exchange information and opinions about those risks [14].
Professionals need to support patients by providing the relevant data in accessible, often visual,
formats. Raynor et al. concluded that numerical risk information, rather than verbal descriptors,
ensured a more accurate estimation of the probability and likelihood of adverse effects [12].

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Risks of inadequate information

The dangers posed by inadequately informing patients are well known. In a study of patients
admitted to hospital with an acute gastrointestinal bleed who had been taking nonsteroidal anti-
inflammatory drugs and matched controls from local general practices, Wynne and Long found
that the hospital patients knew less about the adverse effects of their drugs but had also been
more compliant [15]. More generally, if a medication error has occurred, the patient may be
placed at risk if the professional focuses exclusively on adherence. If the patient has stopped
taking a medicine, it is particularly important to find out why, rather than simply emphasizing
the importance of adherence. In this case, it is more important for the professional to ask patients
about any symptoms they may have experienced. Jarernsiripornkul et al. suggested that a
symptom checklist, such as that used in their study, could help identify problems that patients
perceive as being related to their drug therapy [5].

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Preventing medication errors

The role of the patient in preventing medication errors has not been well studied. It has been
suggested that allowing patients in hospital to administer at least some of their own medicines
might help [16], and a system to empower patients has been proposed [17]. However, patients
frequently make medication errors and the risk is greater in elderly patients. In a study of 178
elderly, chronically ill, ambulatory patients, 59% made one or more errors in their medications,
and the errors were potentially serious in 26%; those who erred at all were more likely to make
multiple mistakes than single mistakes, the average number being 2.6 errors per error-making
patient [18]. In a more recent study in 6718 elderly subjects being cared for at home, 30% had
evidence of a potential medication problem or were taking a drug considered inappropriate for
older people; the risk increased linearly with the number of medications taken [19]. Information
leaflets may help to reduce patients' own medication errors [20].

Parent involvement in prescribing was not found to be beneficial in a study in 1410 pairs of
parents and children, of whom 1097 had a total of 2234 orders or prescriptions written, 1289
(58%) being associated with at least one medication error; of 1755 errors, 232 were serious and
preventable [21]. A patient-centred health information technique designed to enhance
communication between parents and clinicians during emergency care was used in 654 patients.
The parents used the technology to enter data on symptoms and medication-related history and a
printout provided recommendations to the clinicians. However, the system did not significantly
affect the number of errors.

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The patient and pharmacovigilance

The role of the patient extends beyond the resolution of their own difficulties, although they may
not always know this. They also have a role to play in pharmacovigilance, either directly or
indirectly. The two main methods of identifying new reactions are spontaneous reporting of
suspected adverse drug reactions and prescription event monitoring for new drugs. Both methods
require patients to report their symptoms, either to healthcare professionals or directly to the
responsible regulatory authorities. The low level of reporting by healthcare professionals is well
known [22], and patients are increasingly being allowed and encouraged to report suspected
adverse drug reactions directly.

In their review of patient reporting systems in six countries, Blenkinsopp et al. concluded that
there was some evidence that patients' reports and professional reports were of similar quality;
that patients report different adverse drug reactions from professionals; that patients report new
adverse drug reactions and report more quickly than professionals; and that patients' reports are
initially more time-consuming to process [6]. Overall, they concluded that the limited evidence
so far suggests that patient reporting of suspected adverse drug reactions has more potential
benefits than drawbacks, and that evaluation of patient reporting systems is needed to provide
further evidence.

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Conclusion
This area is relatively under-researched and there remain several unanswered questions. We do
not know enough about how patients make attributions of adverse effects of medications. Little
work has been carried out to develop and evaluate ways of encouraging patients to tell
prescribers about perceived problems with their medications, without either alarming them or
causing doctors to become defensive, and of facilitating balanced discussions of adverse effects.
More work is needed to find ways of helping patients to avoid making medication errors
themselves. The new National Institute for Health and Clinical Excellence guideline on
medicines adherence recommends that professionals should ask patients if they have any
concerns about their medicines, including concerns about adverse effects [23]. Such an approach
is more likely to yield information conducive to the identification of medication errors than a
narrow focus on adherence.
 REPORTING
AND
DOCUMENTING
MEDICATION
ERRORS
OBJECTIVES:
To describe the proportion and types of medical errors that are stated to be reported via incident report
systems by physicians and nurses who care for pediatric patients and to determine attitudes about
potential interventions for increasing error reports.
METHODS:
A survey on use of incident reports to document medical errors was sent to a random sample of 200
physicians and nurses at a large children's hospital. Items on the survey included proportion of medical
errors that were reported, reasons for underreporting medical errors, and attitudes about potential
interventions for increasing error reports. In addition, the survey contained scenarios about hypothetical
medical errors; the physicians and nurses were asked how likely they were to report each of the events
described. Differences in use of incident reports for documenting medical errors between nurses and
physicians were assessed with chi(2) tests. Logistic regression was used to determine the association
between health care profession type and likelihood of reporting medical errors.
RESULTS:
A total of 140 surveys were returned, including 74 from physicians and 66 by nurses. Overall, 34.8% of
respondents indicated that they had reported <20% of their perceived medical errors in the previous 12
months, and 32.6% had reported <40% of perceived errors committed by colleagues. After controlling for
potentially confounding variables, nurses were significantly more likely to report >or=80% of their own
medical errors than physicians (odds ratio: 2.8; 95% confidence interval: 1.3-6.0). Commonly listed
reasons for underreporting included lack of certainty about what is considered an error (indicated by
40.7% of respondents) and concerns about implicating others (37%). Potential interventions that would
lead to increased reporting included education about which errors should be reported (listed by 65.4% of
respondents), feedback on a regular basis about the errors reported (63.8%) and about individual events
(51.2%), evidence of system changes because of reports of errors (55.4%), and an electronic format for
reports (44.9%). Although virtually all respondents would likely report a 10-fold overdose of morphine
leading to respiratory depression in a child, only 31.7% would report an event in which a supply of breast
milk is inadvertently connected to a venous catheter but is discovered before any breast milk goes into
the catheter.
CONCLUSIONS:
Medical errors in pediatric patients are significantly underreported in incident report systems, particularly
by physicians. Some types of errors are less likely to be reported than others. Information in incident
reports is not a representative sample of errors committed in a children's hospital. Specific changes in the
incident report system could lead to more reporting by physicians and nurses who care for pediatric
patients.
 STRATEGIES
FOR REDUCING
MEDICATION
ERRORS
Multiple Factors
Since 1992, the Food and Drug Administration has received nearly 30,000 reports of medication errors. These are
voluntary reports, so the number of medication errors that actually occur is thought to be much higher. There is no
"typical" medication error, and health professionals, patients, and their families are all involved. Some examples:
A physician ordered a 260-milligram preparation of Taxol for a patient, but the pharmacist prepared 260 milligrams of
Taxotere instead. Both are chemotherapy drugs used for different types of cancer and with different recommended
doses. The patient died several days later, though the death couldn't be linked to the error because the patient was
already severely ill.
An older patient with rheumatoid arthritis died after receiving an overdose of methotrexate--a 10-milligram daily dose
of the drug rather than the intended 10-milligram weekly dose. Some dosing mix-ups have occurred because daily
dosing of methotrexate is typically used to treat people with cancer, while low weekly doses of the drug have been
prescribed for other conditions, such as arthritis, asthma, and inflammatory bowel disease.
One patient died because 20 units of insulin was abbreviated as "20 U," but the "U" was mistaken for a "zero." As a
result, a dose of 200 units of insulin was accidentally injected.
A man died after his wife mistakenly applied six transdermal patches to his skin at one time. The multiple patches
delivered an overdose of the narcotic pain medicine fentanyl through his skin.
A patient developed a fatal hemorrhage when given another patient's prescription for the blood thinner warfarin.
These and other medication errors reported to the FDA may stem from poor communication; misinterpreted
handwriting; drug name confusion; confusing drug labels, labeling, and packaging; lack of employee knowledge; and
lack of patient understanding about a drug's directions. "But it's important to recognize that such errors are due to
multiple factors in a complex medical system," says Paul Seligman, M.D., director of the FDA's Office of
Pharmacoepidemiology and Statistical Science. "In most cases, medication errors can't be blamed on a single
person."
A medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm
while the medication is in the control of the health care professional, patient, or consumer," according to the National
Coordinating Council for Medication Error Reporting and Prevention. The council, a group of more than 25 national
and international organizations, including the FDA, examines and evaluates medication errors and recommends
strategies for error prevention.

A Regulatory Approach
The public took notice in 1999 when the Institute of Medicine (IOM) released a report, "To Err is Human: Building a
Safer Health System." According to the report, between 44,000 and 98,000 deaths may result each year from medical
errors in hospitals alone. And more than 7,000 deaths each year are related to medications. In response to the IOM's
report, all parts of the U.S. health system put error reduction strategies into high gear by re-evaluating and
strengthening checks and balances to prevent errors.
In addition, the U.S. Department of Health and Human Services (HHS) and other federal agencies formed the Quality
Interagency Coordination Task Force in 2000 and issued an action plan for reducing medical errors. In 2001, former
HHS Secretary Tommy G. Thompson announced a Patient Safety Task Force to coordinate a joint effort to improve
data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the
Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality.
The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which
included forming a new division on medication errors at the agency in 2002. "FDA works to prevent medication errors
before a drug reaches the market and monitors any errors that may occur after that," says Jerry Phillips, R.Ph.,
former director of the FDA's Division of Medication Errors and Technical Support.
Here's a look at key areas in which the FDA is working to reduce medication errors.
Bar code label rule: After a public meeting in July 2002, the FDA decided to propose a new rule requiring bar codes
on certain drug and biological product labels. Health care professionals would use bar code scanning equipment,
similar to that used in supermarkets, to make sure that the right drug in the right dose and route of administration is
given to the right patient at the right time.
"It's a promising way to automate aspects of medication administration," says Robert Krawisz, former executive
director of the National Patient Safety Foundation. "The technology's impact at VA hospitals so far has been
amazing." The Department of Veterans Affairs (VA) already uses bar codes nationwide in its hospitals, and the result
has been a drastic reduction in medication errors. For example, the VA medical center in Topeka, Kan., has reported
that bar coding reduced its medication error rate by 86 percent over a nine-year period.
 Here's how it works: When patients enter the hospital, they get a bar-coded identification wristband that can
transmit information to the hospital's computer, says Lottie Lockett, R.N., a nursing administrator at the Houston VA
Medical Center. Nurses have laptop computers and scanners on top of medication carts that they bring to patients'
rooms. Nurses use the scanners to scan the patient's wristband and the medications to be given. The bar codes
provide unique, identifying information about drugs given at the patient's bedside. "Before giving medications, nurses
use the scanner to pull up a patient's full name and social security number on the laptops, along with the
medications," Lockett says. "If there is not a match between the patient and the medication or some other problem, a
warning box pops up on the screen."
The FDA's final rule on bar code labeling was published on Feb. 26, 2004. The rule, which took effect on April 26,
2004, applies to prescription drugs, biological products (other than blood, blood components, and devices regulated
by the Center for Biologics Evaluation and Research), and over-the-counter (OTC) drugs that are commonly used in
hospitals. Manufacturers, repackers, relabelers, and private label distributors of prescription and OTC drugs would be
subject to the bar code requirements. The agency continues to study whether it also should develop a rule requiring
bar code labeling on medical devices.
Drug name confusion: To minimize confusion between drug names that look or sound alike, the FDA reviews about
300 drug names a year before they are marketed. "About one-third of the names that drug companies propose are
rejected," says Phillips. The agency tests drug names with the help of about 120 FDA health professionals who
volunteer to simulate real-life drug order situations. "FDA also created a computerized program that assists in
detecting similar names and that will help take a more scientific approach to comparing names," Phillips says.
After drugs are approved, the FDA tracks reports of errors due to drug name confusion and spreads the word to
health professionals, along with recommendations for avoiding future problems. For example, the FDA has reported
errors involving the inadvertent administration of methadone, a drug used to treat opiate dependence, rather than the
intended Metadate ER (methylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD). One
report involved the death of an 8-year-old boy after a possible medication error at the dispensing pharmacy. The
child, who was being treated for ADHD, was found dead at home. Methadone substitution was the suspected cause
of death. Some FDA recommendations regarding drug name confusion have encouraged pharmacists to separate
similar drug products on pharmacy shelves and have encouraged physicians to indicate both brand and generic drug
names on prescription orders, as well as what the drug is intended to treat.
The last time the FDA changed a drug name after it was approved was in 2004 when the cholesterol-lowering
medicine Altocor was being confused with the cholesterol-lowering medicine Advicor. Now Altocor is called Altoprev,
and the agency hasn't received reports of errors since the name change. Other examples of drug name confusion
reported to the FDA include:
 Serzone (nefazodone) for depression and Seroquel (quetiapine) for schizophrenia
 Lamictal (lamotrigine) for epilepsy, Lamisil (terbinafine) for nail infections, Ludiomil (maprotiline) for depression,
and Lomotil (diphenoxylate) for diarrhea
 Taxotere (docetaxel) and Taxol (paclitaxel), both for chemotherapy
 Zantac (ranitidine) for heartburn, Zyrtec (cetirizine) for allergies, and Zyprexa (olanzapine) for mental conditions
 Celebrex (celecoxib) for arthritis and Celexa (citalopram) for depression.
Drug labeling: Consumers tend to overlook important label information on OTC drugs, according to a Harris
Interactive Market Research Poll conducted for the National Council on Patient Information and Education and
released in January 2002. In May 2002, an FDA regulation went into effect that aims to help consumers use OTC
drugs more wisely.
The regulation requires a standardized "Drug Facts" label on more than 100,000 OTC drug products. Modeled after
the Nutrition Facts label on foods, the label helps consumers compare and select OTC medicines and follow
instructions. The label clearly lists active ingredients, uses, warnings, dosage, directions, other information, such as
how to store the medicine, and inactive ingredients.
As for health professionals, the FDA proposed a new format in 2000 to improve prescription drug labeling for
physicians, also known as the package insert. One FDA study showed that practitioners found the labeling to be
lengthy, complex, and hard to use. The proposed redesign would feature a user-friendly format and would highlight
critical information more clearly. The FDA is still reviewing public comments on this proposed rule. The agency also
has been working on a project called DailyMed, a computer system that will be available without cost from the
National Library of Medicine next year. DailyMed will have new information added daily, and will allow health
professionals to pull up drug warnings and label changes electronically.
Error tracking and public education: The FDA reviews medication error reports that come from drug manufacturers
and through MedWatch, the agency's safety information and adverse event reporting program. The agency also
receives reports from the Institute for Safe Medication Practices (ISMP) and the U.S. Pharmacopeia, or USP (see
"Who Tracks Medication Errors?").
 A recent ISMP survey on medication error reporting practices showed that health professionals submit reports more
often to internal reporting programs such as hospitals than to external programs such as the FDA. According to the
ISMP, one reason may be health professionals' limited knowledge about external reporting programs.
The FDA receives and reviews about 300 medication error reports each month and classifies them to determine the
cause and type of error. Depending on the findings, the FDA can change the way it labels, names, or packages a
drug product. In addition, once a problem is discovered, the FDA educates the public on an ongoing basis to prevent
repeat errors.
In 2001, the agency released a public health advisory to hospitals, nursing homes, and other health care facilities
about the hazards of mix-ups between medical gases, which are prescription drugs. In one case, a nursing home in
Ohio reported four deaths after an employee mistakenly connected nitrogen to the oxygen system.
The ISMP reports medication errors through various newsletters that target health professionals in acute care,
nursing, and community/ambulatory care. The ISMP also has launched a newsletter for consumers called Safe
Medicine.
In December 2003, the USP released an analysis of medication errors captured in 2002 by its anonymous national
reporting database, MedMARX. Of the errors reported to MedMARX, slightly more than one-third reached the patient
and involved a geriatric patient. Many of these medication errors were found to be harmful.

What Consumers Can Do

In one case reported to the ISMP, a doctor called in a prescription for the antibiotic Noroxin (norfloxacin) for a patient
with a bladder infection. But the pharmacist thought the order was for Neurontin (gabapentin), a medication used to
treat seizures. The good news is that the patient read the medication leaflet stapled to his medication bag, noticed the
drug he received is used to treat seizures, and then asked about it. ISMP president Michael Cohen, R.Ph., Sc.D.,
says, "You should expect to count on the health system to keep you safe, but there are also steps you can take to
look out for yourself and your family."
 Know what kind of errors occur. The FDA evaluated reports of fatal medication errors that it received from 1993 to
1998 and found that the most common types of errors involved administering an improper dose (41 percent),
giving the wrong drug (16 percent), and using the wrong route of administration (16 percent). The most common
causes of the medication errors were performance and knowledge deficits (44 percent) and communication errors
(16 percent). Almost half of the fatal medication errors occurred in people over 60. Older people are especially at
risk for errors because they often take multiple medications. Children are also a vulnerable population because
drugs are often dosed based on their weight, and accurate calculations are critical.
 Find out what drug you're taking and what it's for. Rather than simply letting the doctor write you a prescription and
send you on your way, be sure to ask the name of the drug. Cohen says, "I would also ask the doctor to put the
purpose of the prescription on the order." This serves as a check in case there is some confusion about the drug
name. If you're in the hospital, ask (or have a friend or family member ask) what drugs you are being given and
why.
 Find out how to take the drug and make sure you understand the directions. If you are told to take a medicine
three times a day, does that mean eight hours apart exactly or at mealtimes? Should the medicine be stored at
room temperature or in the refrigerator? Are there any medications, beverages, or foods you should avoid? Also,
ask about what medication side effects you might expect and what you should do about them. And read the
bottle's label every time you take a drug to avoid mistakes. In the middle of the night, you could mistake ear drops
for eye drops, or accidentally give your older child's medication to the baby if you're not careful. Use the measuring
device that comes with the medicine, not spoons from the kitchen drawer. If you take multiple medications and
have trouble keeping them straight, ask your doctor or pharmacist about compliance aids, such as containers with
sections for daily doses. Family members can help by reminding you to take your medicine.
 Keep a list of all medications, including OTC drugs, as well as dietary supplements, medicinal herbs, and other
substances you take for health reasons, and report it to your health care providers. The often-forgotten things that
you should tell your doctor about include vitamins, laxatives, sleeping aids, and birth control pills. One National
Institutes of Health study showed a significant drug interaction between the herbal product St. John's wort and
indinavir, a protease inhibitor used to treat HIV infection. Some antibiotics can lower the effectiveness of birth
control pills. If you see different doctors, it's important that they all know what you are taking. If possible, get all
your prescriptions filled at the same pharmacy so that all of your records are in one place. Also, make sure your
doctors and pharmacy know about your medication allergies or other unpleasant drug reactions you may have
experienced.
 If in doubt, ask, ask, ask. Be on the lookout for clues of a problem, such as if your pills look different than normal or
if you notice a different drug name or different directions than what you thought. Krawisz says it's best to be
cautious and ask questions if you're unsure about anything. "If you forget, don't hesitate to call your doctor or
pharmacist when you get home," he says. "It can't hurt to ask."
Who Tracks Medication Errors?

The Food and Drug Administration

Accepts reports from consumers and health professionals about products regulated by the FDA, including drugs and
medical devices, through MedWatch, the FDA's safety information and adverse event reporting program.
(800) 332-1088
www.fda.gov/medwatch.htm
Institute for Safe Medication Practices
Accepts reports from consumers and health professionals related to medication. Publishes Safe Medicine, a
consumer newsletter on medication errors.
1800 Byberry Road, Suite 810 Huntingdon Valley, PA 19006-3520
(215) 947-7797
www.ismp.org
U.S. Pharmacopeia
The Medication Errors Reporting (MER) Program, in cooperation with the Institute for Safe Medication Practices, is a
voluntary national medication error reporting program.
12601 Twinbrook Parkway
Rockville, MD 20852 (800) 23-ERROR (233-7767)
www.usp.org
MedMARX
USP's anonymous medication error reporting program used by hospitals. These data are not submitted to the FDA.
www.medmarx.com

Hospital Strategies
Hospitals and other health care organizations work to reduce medication errors by using technology, improving
processes, zeroing in on errors that cause harm, and building a culture of safety. Here are a couple of examples.
Pharmacy intervention: It was a challenge for health care providers, especially surgeons, at Fairview Southdale
Hospital in Edina, Minn., to ensure that patients continued taking their regularly prescribed medicines when they
entered the hospital, says Steven Meisel, Pharm.D., director of medication safety at Fairview Health Services.
"Surgeons are not typically the original prescribers," he says. The solution was to have pharmacy technicians record
complete medication histories on a form. In a pilot program, the technicians called most patients on the phone a
couple of days before surgery. A pharmacist reviewed the information, and then the surgeon decided which
medications should be continued. After three months, the number of order errors per patient dropped by 84 percent,
and the pilot program became permanent.
Computerized Physician Order Entry (CPOE): Studies have shown that CPOE is effective in reducing medication
errors. It involves entering medication orders directly into a computer system rather than on paper or verbally. The
Institute for Safe Medication Practices conducted a survey of 1,500 hospitals in 2001 and found that about 3 percent
of hospitals were using CPOE, and the number is rising. Eugene Wiener, M.D., medical director at the Children's
Hospital of Pittsburgh, says, "There is no misinterpretation of handwriting, decimal points, or abbreviations. This puts
everything in a digital world."
The Pittsburgh hospital unveiled its CPOE system in October 2002. Developed by the hospital and the Cerner Corp.
in Kansas City, Mo., Children'sNet has replaced most paper forms and prescription pads. Wiener says that, unlike
with adults, most drug orders for children are generally based on weight. "The computer won't let you put an order in
if the child's weight isn't in the system," he says, "and if the weight changes, the computer notices." The system also
provides all kinds of information about potential drug complications that the doctor might not have thought about.
"Doctors always have a choice in dealing with the alerts," Wiener says. "They can choose to move past an alert, but
the alert makes them stop and think based on the specific patient indications."
 Patient Safety Proposals
In March 2003, the Department of Health and Human Services announced two new FDA strategies that will use
state-of-the-art technology to improve patient safety.
 Bar codes: Just as the technology is used in retail and other industries, required bar codes would contain unique
identifying information about drugs. When used with bar code scanners and computerized patient information
systems, bar code technology can prevent many medication errors, including administering the wrong drug or
dose, or administering a drug to a patient with a known allergy. The requirement took effect in April 2004.
 Safety reporting: A proposed revamping of safety reporting requirements aims to enhance the FDA's ability to
monitor and improve the safe use of drugs and biologics. In 2003, the FDA published a proposed rule. The rule, if
enacted, would improve the quality and consistency of safety reports, require the submission of all suspected
serious reactions for blood and blood products, and require reports on important potential medication errors.
 PROVIDING
CLIENT EDUCATION
FOR
MEDICATION
USAGE
Drug information on labels and inserts is a major source of knowledge for patients as they attempt to balance the risks and
benefits of drugs and administer them safely. Yet this information is often inconsistent, incomplete, and difficult for
patients to read and understand. We reviewed the numerous sources of written prescription drug information, the
regulations that govern their content and format and the lack of oversight in the process, and the history that led to this
system. We suggest that oversight and standards are needed so that written drug information can serve as a coherent and
organized system to educate patients.

No consumer-information standards have been implemented for drugs, the most potentially hazardous products regulated
by the FDA.

TO MAKE THOUGHTFUL DECISIONS about using medications and to take them safely and appropriately,
patients must have at least a basic understanding about the risks and benefits of their prescribed
drugs and how to administer them. Recent safety problems associated with commonly prescribed
and aggressively advertised medications such as the COX-2 inhibitors and anti-depressants have
increased awareness about the importance of considering medication risks. In its 2006
report, Preventing Medication Errors, the Institute of Medicine (IOM) highlighted the pervasive problem of
poor medication safety.1 Ideally, patients should receive counseling about risks, benefits, and safe
administration of medications from their physicians and pharmacists. Surveys indicate that most
patients prefer to receive this information from their physicians, as learned intermediaries. 2 However,
there is considerable evidence that such discussions occur infrequently and are often quite
limited.3 A recent study evaluated audiotaped office visits and found major shortfalls in the quality of
information communicated to patients about their prescribed medicines; physicians explained
adverse effects and duration of therapy in only about a third of the discussions and provided
patients with instructions for use in only 55 percent of the discussions. 4 Communication with
pharmacists is also inadequate.5 As a result, many patients rely on written information, either on
labels or in package inserts.
Even among those who do receive information from clinicians, many likely will not remember this
information shortly after the visit and will look to labels and associated written information for
ongoing guidance.6 Written information has also been shown to augment patients’ knowledge about
prescription drugs, even when oral communication does occur.7 Although efforts to improve oral
communication about medications must persist, improving written medication information is one
straightforward way to help patients safely and appropriately administer their medications.
Evaluation of the quality of that information and policy options to improve it will benefit patients.
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Patients’ Understanding Of Written Medication Information

Health literacy.
About half of Americans have difficulty reading and using health information; poor health literacy is a critical barrier to
adequate care.8 These problems are especially important concerning medication information. 9 In a recent multisite study of
primary care patients, nearly half were unable to understand one or more of the label instructions on five common
prescription drugs.10 Another study evaluated low-literacy patients’ ability to interpret warning stickers (usually colorful
stickers often indiscriminately placed on the backs of prescription bottles) and found profound deficits in their
understanding.11 Elderly patients have particular difficulty reading and understanding drug labeling.12 In a survey of older
hospitalized patients prior to discharge, only 40 percent reported no problems in reading their drug labels, and even fewer
reported that they had a clear understanding of the instructions. Another survey of geriatric patients found that they
frequently did not understand how to time their dosing in relation to meals. 13 In younger populations, an evaluation of
parents’ ability to comprehend drug labels for their children and calculate appropriate doses found that 77 percent of the
adults studied were unable to correctly administer oral rehydration therapy, 56 percent were unable to calculate
appropriate doses of cough syrup, and 68 percent planned therapy schedules that led to incorrect dosing. 14
Medication errors.
These limitations likely contribute to the high rates of medication error seen in the outpatient setting. In its report on
medication errors, the IOM estimates that 1.5 million medication errors occur annually in the United States. A large
proportion of these occur in the outpatient setting, generating costs of more than $3.5 billion. 15 Poor labeling was identified
as a critical source of those errors. Similarly, U.S. Pharmacopoeia reports that about a third of errors it evaluates are
attributable at least in part to inadequate labeling.16 Poor understanding of medication instructions might also inhibit a
patient’s ability to adhere to therapy as prescribed.
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Sources Of Written Prescription Drug Information

Container labels and CMI leaflets.
Patients have several sources of written information about prescription drugs. The container label provides basic drug
information such as the drug name, dose, instructions, pharmacy, and patient’s name. The container also sometimes
includes auxiliary stickers to communicate additional warnings and administration directions. Supplementary leaflets often
accompany prescriptions filled, referred to as “consumer medication information” (CMI). 17 These have more surface area
than the container label and are used to communicate additional information about medication directions, risks, and
benefits.
Package inserts.
Some drugs are dispensed with a package insert, a document approved by the Food and Drug Administration (FDA) that
contains scientific information about pharmacokinetics, pharmacodynamics, molecular structure, indications, risks, and
benefits. Despite recent formatting changes to simplify readability, this document uses technical language aimed at
physicians but is frequently delivered to patients via single-dose containers packaged by the manufacturer. 18
Medication Guides.
In addition, federal regulations require that some drugs be accompanied by a Medication Guide, providing more detailed
risk information. The FDA requires Medication Guides for drugs that represent a “significant public health concern,” such
as Accutane (isotretinoin) in women of child-bearing ages or, more recently, all nonsteroidal anti-inflammatory drugs
(NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), to provide warnings for cardiovascular risks and suicide,
respectively.19 Only forty-four active ingredients now require Medication Guides; they range from commonly prescribed
medications with formulations available over the counter to rarely used biologics to treat metastatic cancer. 20Rarely,
manufacturers prepare a patient-oriented document called a patient package insert, required for oral contraceptives and
inhaled isoproteronol, that must be approved by the FDA and can be packaged with the drug. 21 The use of these ancillary
materials is variable, however. Even mandated Medication Guides frequently are not provided, and an underfunded FDA
lacks the capacity to police its regulations.22 Thus, patients may receive any number of combinations of these information
sources with their drug, or just the container label.
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Fragmentation In Creating And Regulating Drug Information

The development and presentation of these various types of written materials occurs in a fragmented and disorganized
way, with numerous organizations participating in their development (Exhibit 1⇓). The content of container labels is
regulated jointly by the FDA and state boards of pharmacy. The FDA requires several items to be included on all
prescription drug container labels, including the name and address of the pharmacy, serial number of the prescription,
prescriber, patient’s name, name and dose of the drug, and directions for use.23State pharmacy boards then specify their
own requirements. The FDA has no regulations and state pharmacy boards have few regulations concerning the format of
container labels, which are determined by the dispensing pharmacy and its software vendor.
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EXHIBIT 1
Types And Regulation Of Commonly Dispensed Written Prescription Drug Information For Patients

Although the government has established guidelines concerning CMI, its content and format are ultimately determined by
a few private firms that compile and sell libraries of medication monographs to pharmacies. First DataBank and Medispan
constitute the majority of this market.24 The format of CMI is determined by local pharmacies and their software vendors.
By contrast, the content and format of the package insert and mandated guides are strictly regulated by the FDA.25
These written sources offer patients a complex menu from which to identify information about their medications, with no
single source responsible for oversight of how these components fit together to provide patients with useful,
comprehensive drug information.

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History Of Efforts To Regulate CMI

The FDA has long struggled to establish its role in regulating CMI—one particular component of written medication
information (Exhibit 2⇓). In the 1970s, the agency identified CMI as an important adjunct to medication counseling and in
1979 proposed regulations requiring educational leaflets to accompany all prescriptions filled. By 1980, at the end of the
Carter administration, regulations were finalized requiring manufacturers to prepare such information, for a limited
number of medication classes at first. However, these regulations were revoked early in the Reagan administration, which
determined that the private sector should provide all necessary written information that patients required.
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EXHIBIT 2
History Of Efforts To Regulate Consumer Medication Information (CMI)

This did not prove to be the case. By 1995, the FDA, dissatisfied with progress in the provision of written information to
consumers, again proposed regulations to require manufacturers to produce and distribute standardized consumer leaflets
and specified guidelines for their content and quality. In August 1995, despite strong support from consumer groups such
as Public Citizen, the agency was blocked by a consortium of stakeholders including pharmacists, drug manufacturers, and
the American Medical Association (AMA). Pharmacists and physicians expressed concerns about government intrusion
into clinical practice and the importance of clinical autonomy. Manufacturers expressed similar concerns and were intent
on keeping the physician in the role of learned intermediary, protecting manufacturers from additional liability.

Action Plan.
Instead, the FDA convened a task force to develop and implement a long-rangeAction Plan for the Provision of Useful
Prescription Medicine Information. It stated that by 2000, 75 percent of new prescriptions would be accompanied by CMI,
and 95 percent by 2006.26 Eight quality criteria were established, ranging from scientific accuracy to legible formatting.
These criteria were to be only guidelines; the FDA received no power to regulate content or format and continued to rely
on the private sector to create the material. With enactment of the Medication Guide rule in 1996, the FDA secured
authority over information leaflets only for those drugs they judged to raise a “serious and significant public health
concern.”27
Measuring progress.
In 2000, the FDA sought to measure how well the private sector was meeting the interim goals of the Action Plan. A
nationwide study was performed by Bonnie Svarstadt and colleagues, who sent trained shoppers to fill 918 new
prescriptions at 306 randomly selected pharmacies in 8 states to evaluate the CMI received. 28The study found that
distribution guidelines were exceeded, with 87 percent of prescriptions accompanied by CMI. However, the CMI quality
was quite poor, with its contents, length, and quality varying greatly by pharmacy. Fewer than half of the materials
presented acceptable information about how to take the medication, receive maximal benefit, and interpret benefits. Only
about a quarter included acceptable information about medication precautions and how to avoid adverse reactions, and
fewer than a fifth contained acceptable information about contraindications and what to do in case of a contraindication. In
2007, the FDA is due to assess whether the final goals set out in the Action Plan have been met. Despite decades-long
efforts to improve medication leaflets, the FDA still has no regulatory control over this material.
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Information Quality And Variability

A growing body of data indicates that instead of the marketplace producing an ever more useful portfolio of information
resources, the lack of regulation of such information has led to the proliferation of products that are patient- unfriendly and
of poor quality. Information is often presented in an excessively complex manner, even though many Americans
(especially those over age sixty-five) read at a sixth-grade level or below.29 In addition to Svarstadt and colleagues’ work,
studies have demonstrated that CMI, patient package inserts, and Medication Guides are often presented in a type size
smaller than 10 point (too small for many older patients to see) and written at a tenth-grade level or greater (a challenge for
those with poor health literacy). 30

Although Svarstadt and colleagues’ analysis documented great variability of CMI, no published studies to date have
thoroughly evaluated the level of variability in container labels. But even a casual observation of those labels reveals
striking variability in the content and format of information presented.

Thus, the FDA applies quite different levels of scrutiny to risk information for different audiences. The agency pays very
close attention to each indication and side effect listed on material aimed at physicians and the format of that information
but plays no role in identifying the content most relevant to patients (except for the small number of Medication Guides)
and only offers unenforced guidelines on formatting.

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Improving The Communication Of Drug Information

Efforts are needed to provide patients with an integrated, coherent information system about their prescription drugs rather
than the redundant, uncoordinated, and hard-to-read pieces of information they receive now. We suggest a new approach
in which information is presented legibly and hierarchically. We should require a standardized container label that is easy
to read, that does not rely on vague and indiscriminate warning stickers, and that clearly delineates administration
directions and key warnings. A single well-organized and standardized leaflet would present more complete information
about risks and benefits and augment the information on container labels. To do this, centralized oversight of the
development of labeling components with minimum standards is needed. More research is also needed to evaluate the
optimal ways to communicate written information to patients to create a system that best educates patients about
medications.

Value of standardization.
Better oversight of the labeling process would offer several key improvements. A standardized container label could use
evidence-based techniques to optimize formatting. Larger type sizes, a schematic organization of drug information, and
judicious use of white space represent basic formatting techniques shown to improve readability and understanding. 31

Consistency of formatting between pharmacies could simplify the search for information. Better oversight would also
present an opportunity to require information for patients who do not speak English, those with poor vision, or those with
low reading levels. Such information might help reduce medication errors caused by patients’ poor health literacy and
could provide more-equitable care.

New standards for written drug information could also help ensure consistency in the content of information. To do this, it
will be necessary to identify the specific risks and instructions that should be included for each drug. In this approach, all
container labels for a given drug (such as ibuprofen) would include the same administration instructions (for example, take
with milk or food) and warnings (for example, if you develop stomach upset or black, tarry stools, contact your physician).
Less variability could reduce the likelihood that medication errors or adverse-event rates will vary depending on the
pharmacy chosen.

Successful standardization for other products.

It is instructive to compare the different ways that the FDA has managed the standardization of labeling formats for other
products under its jurisdiction. Consumers who buy food at a grocery store know where to find nutrition information on
the FDA’s standardized “Nutrition Facts” label. People who purchase over-the-counter medications can use uniform
“Drug Facts” labels to help find administration directions or risk information. Yet no such standards have been
implemented for prescription drugs, arguably the most complex and potentially hazardous of the products regulated by the
FDA.

Regulatory limitations and options.

We propose that the FDA develop and require minimum standards for the content and format of both container labels and
CMI.32 Although labels have traditionally been under state control, the FDA has recently taken the controversial position
that its statements about drug risk should preempt any differing opinions held at the state level. 33 If this is true, then the
agency should be equally comfortable preempting state variation in the presentation of information on medication
containers. If considerations of federalism turn out to limit the FDA’s authority to regulate container labels at the state
level, partnerships could nonetheless be developed between state pharmacy boards and the FDA to develop and implement
improved patient information standards.
Examples from other countries.
Standards have been implemented in the European Union for manufacturers to develop writte materials that must adhere to
strict guidelines and must be approved by the European Medicines Agency.34 However, medication there is generally
dispensed in individual-use packaging, which simplifies the delivery of materials created by manufacturers. Most U.S.
pharmacies purchase medications in bulk and repackage prior to dispensing. In Canada, where bulk purchasing is also
common, manufacturers are required to develop a dedicated patient leaflet for all new drugs as part of the federally
approved product labeling, but little is known about the frequency with which these leaflets are delivered to patients at
pharmacies.35 A discussion about the best party to create written materials (manufacturers; private companies that contract
with pharmacies; a government agency; or a nonprofit agency) is needed and warrants thorough exploration.
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The Right Time For Change

Growing concerns about the quality and safety of prescription drugs have helped open a political window for action on
written prescription drug information. With implementation of Medicare Part D in 2006, the federal government has
become the nation’s largest purchaser of prescription drugs. This investment confers even greater responsibility to ensure
that patients take their medications safely, maximizing the return on the government’s investment.

The recent IOM report highlighting the high frequency and costs associated with medication errors, citing poor labeling as
an important cause of this problem, adds fuel to the argument to improve written information. A growing awareness of the
problems associated with poor health literacy adds additional support, and physician groups such as the AMA now
strongly support initiatives to improve health literacy and seem unlikely to oppose such efforts. Greater public concern
over medication safety might force prescription drug manufacturers, who previously opposed CMI standardization, to be
amenable to these efforts. Consumer groups such as Public Citizen and the Center for Medical Consumers have expressed
a keen interest in change.36 All of these stakeholders would no doubt be eager to participate in a dialogue about requiring
standards for written drug information. Doing so could provide patients with an information system that could improve
their understanding and use of prescription drugs.
HERBAL THERAPY
WITH
NURSING
IMPLICATIONS