REDUCING PRESCRIPTION MEDICATION ERRORS: What You Need To Know and What Your Patients Should Be Told
It has been almost a decade since the Institute of Medicine (IOM)
report entitled To Err Is Human: Building a Safer Health System drew national attention to the occurrence, clinical consequences,
and cost of medical errors in the United States.1 The report estimated that between 44,000 and 98,000 deaths result each year
from medical errors.1 Additionally, medication errors alone account
for over 7,000 deaths annually.1 In response to this report, the US
health care system re-evaluated and strengthened error reduction
strategies to improve patient safety. Nevertheless, medication errors
remain a national concern. In 2006, the IOM report, Preventing
Medication Errors, estimated that at least 1.5 million patients are
harmed each year by medication errors, costing the health care system billions of dollars.2
The National Coordinating Council for Medication Error
Reporting and Prevention (NCCMERP) defines a medication
error as “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.”3 This definition recognizes that errors can occur at any point in
the medication use process and in any setting. Therefore, every
component of the health care system, including health care professionals and patients, has a role in preventing medication errors.
By preventing these errors, patient safety is improved and the
potential for subsequent legal consequences is decreased. To assist
pharmacists and pharmacy staff in further understanding the
importance of their role in medication error prevention, this article will provide information on the various types and causes of
prescription medication errors, strategies to reduce them, as well
as the potential legal consequences that may arise when prescription medication errors occur.
TYPES OF MEDICATION ERRORS
Medication use is a complex, multi-step process that involves several individuals at various locations. There are six basic steps in the
medication use process: prescribing, transcribing, dispensing,
administration, monitoring, and patient education (Table 1).4 Every step has the potential for error and the risk to patient safety.
Given that pharmacists have a role in managing and improving
each step of the medication use process, they should be familiar
with the various types of medication errors that could occur.
Table 1. Types of Medication Errors5,7,19,21
| Type of Medication Error |
Description |
| Prescribing |
The inappropriate selection of a drug or drug therapy by the prescriber, or incorrect or inadequate
instructions for use |
Transcription
|
The failure to transcribe information or the improper entry of an order into an information system |
| Dispensing |
The failure to dispense medication as prescribed, or to provide appropriate labeling |
| Administration |
A discrepancy between the drug therapy received and the drug therapy intended |
| Monitoring |
The failure to review a prescribed regimen for appropriate treatment or to assess patient
response to therapy |
| Patient Adherence |
Failure by a patient to take medication(s) as prescribed |
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Prescribing errors involve the prescriber inappropriately selecting a drug (based on indication, contraindication, known allergies,
existing drug therapy, and other factors), dose, dosage form, quantity, route of administration, concentration, rate of administration,
or providing inappropriate or inadequate instructions for use.5 Errors and deficiencies in the prescribing step of the medication
use process are common and account for a large proportion of the
preventable injuries due to medication errors.6
Transcribing errors involve either the failure to transcribe
information or the improper entry of an order into an information
system.7 In regards to pharmacy practice, transcribing errors result
when the prescription is transmitted to the pharmacy, including
oral prescription orders, or as part of the dispensing process, when
the prescription data are entered into the pharmacy system.8 In one study analyzing medication errors in community pharmacies,
it was determined that the majority of errors that reached the
patient occurred during the transcribing stage.8
Dispensing errors can happen during any stage of the dispensing process, from the receipt of a prescription in the pharmacy
through the supply of the product to the patient. A dispensing
error involves the failure to dispense a medication; dispensing of
an incorrect drug, dose, or dosage form; failure to dispense the
correct amount of medication; inappropriate, incorrect, or inadequate labeling of medication; incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing; or
dispensing of expired, improperly stored, or physically or chemically compromised medications.5 The most common types of dispensing errors involve the patient receiving the wrong drug or the
wrong strength.9,10
In 2006, community pharmacies dispensed over 3.4 billion
prescriptions in the US.11 Since pharmacists have direct responsibility for accurately dispensing prescription orders, dispensing
errors are a critical concern for the practice of pharmacy. Although
published studies regarding medication errors in community pharmacies are limited, it has been estimated that overall dispensing
error rates range from 0.26% to 24%.9,12-14 Furthermore, 0.1% to
4% of prescriptions dispensed had the potential to contain clinically significant errors that could cause patient harm or discomfort.12,13 Using a conservative estimate of a 1% overall dispensing error rate, this would translate to over 30 million dispensing errors
in the US each year. An increased awareness of (or attention to)
this issue has placed the pharmacy profession under a microscope,
and has caused the profession to be scrutinized nationally.15-18
Drug administration errors involve a discrepancy between the
drug therapy received by the patient and the drug therapy intended by the prescriber.19 Examples of drug administration errors
include timing errors, omissions, incorrect drug administration
technique, wrong route of drug administration, and administration of an improper dose.20 Drug administration errors are one of
the most common types of medication errors and are a major
source of harm to hospitalized patients.20
Monitoring errors include failure to review a prescribed regimen for appropriate treatment or failure to use appropriate clinical
or laboratory data for adequate assessment of patient response to
the prescribed therapy.5 Studies suggest that up to 3% of hospitalized patients could experience preventable injuries due to monitoring errors.2
In addition to the previously mentioned medication errors,
there are also opportunities for patient adherence errors once the
patient leaves the prescriber’s office, pharmacy, or hospital.
Patient adherence with a medication regimen is generally defined
as the extent to which patients take medications as prescribed by
their health care providers.21 Poor adherence to medication regimens is common and contributes to substantial increases in disease, death, and health care costs.21 Nonadherence, or medication
misuse, may be exhibited by patients in many ways, such as not
having a prescription initially filled or refilled, missing doses,
taking the wrong dose, taking the dose at the wrong time,
and/or stopping a medication without the advice of a health care
professional.22
CAUSES OF MEDICATION ERRORS
A medication error is frequently the end result of multiple factors
within a complex health care system. Medication errors may result
from problems in practice, products, procedures, or systems. A
proper understanding of the factors that may cause or contribute
to medication errors is an essential step in preventing them. Various resources, including the FDA, provide lists of known
factors that may cause or contribute to medication errors.9,22-27These are detailed in Table 2.
Table 2. Known Factors That May Cause
or Contribute to Medication Errors
- Unavailable drug information (such as lack of up-to-date
warnings)
- Miscommunication of drug orders, which can involve poor
handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and
other dosing units, and inappropriate abbreviations
- Lack of appropriate labeling when a drug is prepared and
repackaged into smaller units
- Environmental factors such as lighting, heat, noise, and
interruptions that can distract health care professionals from
their medical tasks
- Complex or poorly designed technology
- Poor procedures or techniques
- Job stress
- Dose miscalculations
- Deficiencies related to knowledge of drug therapy
- General failure to act in accordance with education
and training
- Incorrect diagnosis
- Patient misuse of medication due to lack of patient
information or education
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STRATEGIES TO REDUCE MEDICATION ERRORS
With the potential for medication errors to originate and occur in
every stage of the medication use process, the entire health care system, including health care professionals and patients, has a role in
preventing medication errors. Various types and causes of medication
errors are well documented, and strategies can be implemented or
enhanced to help reduce and avoid future medication errors (Table 3).
Table 3. Strategies To Avoid Medication Errors
- Verify if patients have any allergies and/or reactions to medications
- Inquire of patients if they have any current medical conditions, particularly diabetes, kidney disease, liver disease, cardiovascular disease, and psychiatric disease
- Ask patients about medications they are currently taking, including any nonprescription products, vitamins and minerals, and herbals
- Try to standardize use of height and weight measurements, preferably using metric units
- Make sure drug information databases are up to date
- Compile a list of high-alert medications, ie, medications that require extra precautions when administered, prescribed, dispensed, or refilled.
- Compile a list of similar drug names and circulate it among pharmacy staff, and do not store these drugs near each other
- Ensure patients are aware of the indication for which a drug is prescribed
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For pharmacists and their staff, there are three general strategies that, when used together, can help to prevent medication
errors and improve patient safety. These strategies include appropriate and enhanced education, reporting of medication errors,
and quality assurance programs.
Appropriate and Enhanced Education
Pharmacists and their staff should continue to pursue educational
opportunities that will enhance their knowledge of medication
errors and provide them with specific strategies that can be utilized
to prevent future errors. There are several organizations and agencies, such as the FDA, the Institute for Safe Medication Practices
(ISMP), and the United States Pharmacopeia (USP), that provide
educational and informational materials related to medication
errors, as well as guidance and strategies to improve patient safety.
The FDA has a Medication Errors website, available at www.fda.gov/CDER/drug/MedErrors/default.htm, which provides
basic information on medication errors, specific drug products
associated with medication errors, medication safety videos, how
to report medication errors, and links to additional national organizations that also provide medication error and patient safety
resources. Likewise, the ISMP and USP websites, available at
www.ismp.org and www.usp.org, respectively, provide education
and awareness for health care providers and consumers, as well as
medication safety tools and resources.
One particular example of a medication safety resource available through the ISMP includes a list of high-alert medications
that bear a heightened risk of patient harm when they are used in
error. In addition to the list, special safeguards to reduce the risk
of errors are suggested, and include strategies such as improving
access to information about the listed drugs; limiting access to
high-alert medications; using auxiliary labels and automated alerts;
standardizing the ordering, storage, preparation, and administration of the listed products; and employing redundancies such as
automated or independent double-checks when necessary.
Educational and informational resources regarding medication
errors will also likely be available from the health care organizations or companies that employ pharmacy practitioners, as well as
local, state, and national pharmacy organizations. For some pharmacy practitioners, these programs may be mandatory for employment or professional licensure. Currently, numerous states require
specific health care professionals, such as pharmacists, to complete
educational programs on medication error prevention in order to
obtain or maintain professional licensure.
Medication Error Reporting
The primary reason to report medication errors is for the health
care system to learn how to improve the medication use process.
Medication error reporting is critical in the identification of system deficiencies that can be corrected to prevent future errors. At
the national level, anyone can voluntarily and confidentially report
medication errors, or near misses, to either the USP-ISMP
Medication Error Reporting Program (MERP), available at
www.usp.org or www.ismp.org or to the FDA MedWatch
Program, available at www.fda.gov (Table 4).
Table 4. Sites To Report Medication Errors
| Reporting Programs |
How to Report |
| FDA MedWatch |
Online: www.fda.gov
Phone: 1-800-FDA-1088
Fax: 1-800-FDA-0178 |
| USP-ISMP Medication Error Reporting Program |
Online: www.ismp.org or www.usp.org
Phone: 1-800-23-ERROR
Fax: 301-816-8532 |
|
Reported medication errors are entered into a network of databases that analyze the information and then allows patient safety
organizations to share recommendations with drug manufacturers
and health care providers regarding guidelines, protocols, or best practice steps to take to minimize future occurrences. In addition
to reporting medication errors voluntarily, pharmacists should also
verify with their employers and state administrative agencies if
there are additional medication error reporting requirements.
Quality Assurance Programs
For pharmacists and their staff, medication error prevention
should also include a comprehensive quality assurance program. The importance of undertaking quality improvement initiatives related to pharmacy practice has been recognized at the
national level, and is mandated by various federal and state
administrative agencies. An example of a quality assurance
process used by pharmacies across the country has been termed
CQI, or continuous quality improvement. CQI programs are a
comprehensive approach to improve patient safety that allows
pharmacies to create a proactive, non-punitive environment
that encourages the identification of error, evaluating causes,
and designing systems to prevent future errors. CQI is a systems-based solution that recognizes that the systems that cause or contribute to errors can be modified and improved to be more efficient and effective.
Quality assurance programs should involve pharmacies internalizing new safety strategies and improving systems for their practice. As a result of published reports and studies, including
research from national organizations, valuable information has
been provided that can help to guide pharmacists and other health
care practitioners in their quality assurance and performance
improvement initiatives. Examples of specific strategies that have
been recommended for pharmacies and pharmacists include
implementing professional standards and training; incorporating
automation and computer cross-checks; educating pharmacy staff
on look-alike and sound-alike drug names; incorporating electronically generated prescriptions; redesigning pharmacy dispensing
areas; incorporating computerized systems that provide alerts on
potential errors; and making verbal counseling a part of each prescription dispensed.2
By implementing these and other nationally recommended
strategies, pharmacy practice sites can improve patient safety by
avoiding many of the known factors that cause or contribute to
medication errors. For example, dispensing errors can be reduced
by rearranging product inventory to differentiate between look-alike and sound-alike medications, and by designing pharmacy
dispensing areas that address environmental conditions and minimize distractions. Likewise, incorporating electronically generated
prescriptions can help to decrease miscommunications and deficiencies that could occur in the prescribing and transcribing steps
of the medication use process. Furthermore, by incorporating
patient education and counseling, pharmacists can improve patient
adherence and decrease medication errors associated with improper medication use.
When it comes to medication safety at home, community
pharmacists can be a valuable asset. Providing patient education
and counseling is one of the most vital professional roles of a pharmacist. The patient is usually the last individual in the medication
use process, and pharmacist-patient interactions, such as counseling, have a significant role in identifying medication errors before
they occur.
Pharmacists should view counseling as an opportunity to educate patients about their medications and to verify the accuracy of
dispensing and the patient’s understanding of proper medication
use. Counseling can help patients to understand the reason they
were prescribed the medication, how to properly take the medication, the intended effects and potential side effects associated with
the medication, the importance of adherence, and when to seek
assistance from a health care professional. In particular, helping
patients understand how to properly take their medication is
extremely important given that certain patients, including the
elderly and patients with low health care literacy, may have trouble
understanding and acting on the instructions found on prescription medication labels.22
Because patient misunderstanding of health-related information is one reason that patients misuse medications, pharmacists
should take steps during the counseling process to verify that
patients fully understand their medication therapy (Table 5).
There are multiple patient counseling models available to assist
pharmacists that can be used for new and/or refill medications.
The Indian Health Service Counseling Model provides the following three prime questions to ask patients who are receiving a new
prescription: (1) What did your doctor tell you the medication is
for?; (2) How did the doctor tell you to take it?; and (3) What did
the doctor tell you to expect?28 In addition, pharmacists can ask
patients to show and tell how they are going to take the medication to further verify patient comprehension.28 The show and tell
strategy for patients receiving a refill medication includes asking:
(1) What do you take the medication for?; (2) How do you take
it?; (3) What kind of problems are you having?28 Furthermore, if
possible, the show and tell strategy should also include pharmacists requesting patients to demonstrate administration of medications such as inhalers, nasal sprays, or eye drops.
Table 5. Avoiding Prescription Medication Errors: What Your Patients Should Be Told
Patients and pharmacists need to work together to reduce the occurrence of medication errors. The key is enhanced communication, in which pharmacists inform patients about the medications they are prescribed. Listed below are some examples of information pharmacists should provide.
- The name of the drug and its indications
- Correct dosing, including time to take it and whether or not to take with food
- Common side effects
- Possible drug-drug interactions, including with OTCs
- Possible food-drug interactions
- To have patients check the medication label prior to leaving the pharmacy to ensure they are receiving the correct medication
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Although patient education efforts can help to prevent medication errors, a vast number of patients take prescription medications without being fully informed about them.2 With the large
number of prescriptions dispensed each year in the US, coupled
with pharmacist shortages, the time pharmacists have to routinely
educate and counsel patients may be limited.22 Therefore, pharmacists need to be proactive in providing both verbal counseling and
written drug information to the patients.
In addition to helping patients understand their individual
drug therapy, pharmacists can also help patients to comprehend
their overall role in medication error reduction. Pharmacists
need to engage dialogue with all patients, and encourage their
involvement as partners in the medication use process. In particular, pharmacists should encourage patients to take steps to protect themselves from potential medication misadventures, including to know the different types of medication errors; to recognize
what their medications should look like and visually inspect
them upon each fill or refill; to utilize only one pharmacy; to
check periodically their medications for expiration dates and to
properly discard expired medications; to seek assistance when
purchasing over the counter (OTC) medications; to keep a list of
known allergies and all current medications, including OTC
medications and dietary supplements; and to ask questions if
there is ever any doubt.17,22,25
Facts About Medication Errors
- Patients who suffered unintended drug events remained in the hospital an average of 8 to 12 days longer than patients who did not experience such mistakes. These added days mean their hospital stays cost $16,000 to $24,000 more.1
- A study of medication errors in 36 facilities (hospitals and skilled nursing facilities) indicated a 20% error rate, with 7% of those medication errors capable of producing harm.2
- In a recent survey, one-third of US patients reported a medical, medication, or laboratory error over a two-year span.3
- Since 2000, the FDA has received more than 95,000 reports of medication errors.4
- 530,000 preventable adverse drug events occur each year among outpatient Medicare beneficiaries.5
1 Agency for Health Research and Quality, 2001.
2 Barker, KN, et al. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162:1897-1903.
3 The Commonwealth Fund Commission on a High Performance Health System, Why Not
the Best? Results from a National Scorecard on U.S. Health System Performance, The
Commonwealth Fund, September 2006.
4 FDA. FDA 101: Medication Errors.
5 Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older adults in the ambulatory setting. JAMA. 2003;289:1107-1116. |
LEGAL CONSEQUENCES
OF PRESCRIPTION MEDICATION ERRORS
Undoubtedly, when a prescription medication error occurs, there is
the possibility for a number of consequences to follow. In addition
to the concerns of patient harm and increased cost to the health
care system, health care providers should also be aware of the
potential exposure to legal consequences, which include civil malpractice actions, administrative actions, and/or criminal actions.
Therefore, it is important for pharmacists and pharmacy providers
to understand the potential legal consequences that may arise from
prescription medication errors, and to take proactive risk management steps to avoid them (Table 6).
Table 6. Potential Legal Consequences Associated With Prescription Medication Errors
Civil
Malpractice action where injured patient sues the pharmacy/pharmacist for harm caused by a medication error. If successful, the patient will receive a monetary award.
Administrative
Actions taken by the state board of pharmacy against professional license. Discipline could result in public reprimand; monetary fine; and/or license probation, suspension, or revocation.
Criminal
Involves criminal charges, such as manslaughter or reckless homicide, against the pharmacist as a result of a medication error that caused patient death. If convicted, penalties could involve probation or jail sentence. |
Civil Malpractice Actions
The most common type of legal claim involving pharmacists is
professional negligence, or malpractice claims. According to
reported judicial opinions, the most common type of prescription
medication error leading to pharmacist liability for malpractice is
the straightforward misfilling of a prescription with a drug other
than what the prescriber intended. Previous legal cases have clearly
established that pharmacists have a legal duty to their patients to
accurately fill prescriptions. Therefore, if there is a dispensing error
and the patient, or plaintiff, bringing the lawsuit proves that the
error caused harm, the patient or plaintiff will likely be successful
in the malpractice action.
It is less clear from a legal perspective whether pharmacist
involvement with other types of medication errors, including prescribing and patient adherence errors, will lead to civil liability. An
increasing number of allegations being brought forward against
pharmacists involve scenarios in which the pharmacist filled the
prescription as ordered, but failed to detect that the prescriber had
written for an inappropriate dose or duration of therapy, or where
the pharmacist failed to perform a drug review or counsel the
patient about potential side effects. In contrast to dispensing
errors, which are considered mechanical errors, these types of cases allege intellectual errors. Numerous state courts have addressed
cases considering whether pharmacists can be civilly liable for allegations of intellectual errors; however, the decisions have been
inconsistent. Although some state courts have declined to allow
civil liability, others have held that pharmacists can be liable for
such errors.
Often when plaintiffs initiate civil actions alleging intellectual
errors, they base their legal claims on state administrative laws and
regulations passed as a requirement under the Omnibus
Reconciliation Act of 1990 (OBRA 90). OBRA 90 was a federal
law that recognized pharmacy services extend beyond oversight of
drug distribution, and required pharmacists to actively resolve
potential problems with a patient’s prescription order at the point
of dispensing. Under OBRA 90, pharmacists are required to
screen prescriptions before dispensing, offer patient counseling,
and document relevant patient information.
In regards to counseling, OBRA 90 provides guidance for
pharmacists on important matters that the pharmacist may discuss
with patients (Table 5). These matters include the name and
description of the medication; the route, dosage form, dosage,
route of administration, and duration of drug therapy; special
directions and precautions for preparation, administration and use
by the patient; common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered,
including their avoidance, and the action required if they occur;
techniques for self-monitoring drug therapy; proper storage; and
prescription refill information.
Administrative Actions
To practice pharmacy and provide pharmacy services, pharmacies,
pharmacists, and in some states pharmacy interns and technicians,
must obtain a license through their respective state board of pharmacy. Obtaining a license to practice pharmacy is a privilege, and medication errors have the potential to adversely impact this privilege.
State boards of pharmacy are administrative agencies that
have the authority to regulate the practice of pharmacy and to
protect and promote public health within their state. Many state
boards of pharmacy have determined that medication errors constitute professional misconduct, a direct violation of state pharmacy regulations. Certain types of medication errors may also be considered a violation of additional state or federal laws and regulations. One example would be a misbranding violation for dispensing errors.
State boards of pharmacy may learn of medication errors via
reporting requirements or patient complaints. Typically, once a
pharmacy board becomes aware of a medication error, it will
make a decision if further administrative action is necessary.
Administrative actions and proceedings, such as investigations,
hearings, and disciplinary action, are separate from any malpractice actions that the pharmacy or pharmacist may face from the
injured patient as a result of the same medication error. In addition, unlike malpractice actions that require the plaintiff to prove
harm, administrative actions do not require actual patient harm
to proceed.
If the state board of pharmacy concludes that the licensee (eg,
pharmacy, pharmacist, pharmacy intern, and/or technician) violated administrative regulations, then it will have to determine
appropriate disciplinary action. Depending on the nature of the
offense and any mitigating or aggravating circumstances, licensees
may receive various levels of discipline. Actual examples of state
board of pharmacy disciplinary sanctions resulting from medication errors include public reprimand; monetary fine; and license
probation, suspension, and/or revocation.
FDA and ISMP Campaign to Reduce Medication Mistakes Caused by Unclear Medical Abbreviations
The FDA and the Institute for Safe Medication Practices (ISMP) continue to support an educational campaign focusing on eliminating the use of potentially confusing abbreviations by health care professionals, medical students, medical writers, the pharmaceutical industry, and FDA staff. The program addresses the use of mistake-prone abbreviations in all forms of medical communication, including written medication orders; computer-generated labels; medication administration records; pharmacy or prescriber computer order entry screens; and commercial medication labeling, packaging, and advertising. The ISMP has developed a list of acceptable abbreviations. Further information can be found at www.ismp.org/tools/abbreviations. |
Criminal Actions
While civil law addresses situations in which people have been
harmed and a monetary award might help to remedy the situation,
criminal law addresses the need to investigate crimes, prosecute
those that commit crimes, and hold them accountable, usually
through jail or probationary sentences. Generally, to be found
guilty of a crime, the person accused must have committed a criminal act and had criminal intent. This is usually met when the
accused person purposely, knowingly, or recklessly does an act prohibited by law.
Health care professionals, including pharmacists, are not
immune to criminal actions. It is not uncommon to see criminal
actions against pharmacists that involve allegations of state or federal controlled substance laws being violated, such as a pharmacist
being intentionally or recklessly involved in drug diversion. If a
pharmacist is involved in a medication error there is also the
remote possibility that criminal charges may result.
To date there have been various criminal cases against health
care providers, including pharmacists, in which a medication error
resulted in the death of a patient. One published court case, People
v. Stuart, involved a pharmacist who compounded a prescription
with a misbranded or mislabeled drug. Specifically, the pharmacist
unknowingly used a compound from a bottle which was labeled
sodium citrate but actually contained a mixture of sodium citrate
and sodium nitrate, and a child died as a result of the mistake.29 The pharmacist was charged and convicted of manslaughter after
it was alleged that he committed an “unlawful act” that resulted in
the death of a human being. Ultimately, the manslaughter conviction was not upheld; however, the case highlights that criminal
actions against pharmacists are possible when unintentional medication errors occur and result in patient death. Over the past
decade alone there have been multiple cases in the news in which
health care providers, including pharmacists, were criminally
charged for their involvement in a medication error.
Given the potential legal implications that may arise from
medication errors, it is imperative that pharmacists take proactive
risk-management steps to avoid them. In addition to implementing strategies to prevent errors, it is also important for pharmacists
to comply with federal and state laws and regulations pertaining to
pharmacy, including OBRA 90. Furthermore, as pharmacists experience increasing malpractice claims involving intellectual decisions, effective documentation of professional judgment decisions
is essential. Documentation should be readily available if needed
and can be completed on either the hard copy prescription, in a
journal, or in a computer system. Documented information
should be clear and concise, completely truthful, and include the
names, dates, and times of those involved and when events
occurred. A proper recollection of the facts that led to a decision is
important if legal action is pursued at a later time.
ISMP’s Medication Error Prevention Tool for Community/Ambulatory Pharmacies
The Institute for Safe Medication Practices (ISMP) has designed a medication safety self-assessment tool for community/ambulatory pharmacies to heighten awareness of distinctive characteristics of safe pharmacy systems and to create a baseline of pharmacy efforts to enhance the safety of medications and evaluate these efforts over time. This comprehensive tool also enables assessment of the safety of medication practices in community/ambulatory pharmacies and identifies opportunities for improvement.
The self-assessment tool is divided into ten elements that most significantly influence safe medication use. Each element is defined by one or more core distinguishing characteristics of a safe pharmacy system, which are further divided into individual items to meet that characteristic and key element. Self-assessment characteristics are provided to help evaluate success with each of the core distinguishing characteristics.
Individual staff (including managers, staff pharmacists, technicians, and other support staff ) within each pharmacy site should be provided with a copy of the assessment and asked to complete the items either as a group or individually. A consensus on the responses should then be gathered and opportunities for improvement should be discussed. A plan with goals including system changes with resources needed should be developed and implemented to achieve short- and long-term improvements in medication safety.
It should be noted that the ISMP is not a standards setting organization. The ISMP emphasizes that the self-assessment characteristics represent the ideal and are not purported to represent a minimum standard of practice and should not be considered as such. In fact, some of the self-assessment criteria represent innovative practices and system enhancements that are not widely available in pharmacies today. However, their value in reducing errors is grounded in expert analysis of medication errors, scientific research, or strong evidence of their ability to reduce errors.
Further information on this self-assessment tool for community/ambulatory pharmacies can be found at www.ismp.org/Survey/NewMssacap/Index.asp. |
CASE EXAMPLES
The following two actual legal cases are provided to help to illustrate the potential legal concerns that pharmacists and pharmacy
providers may be exposed to as a result of medication errors.
Case 1
A patient had been taking theophylline under the care of his
family physician. On a subsequent visit to the same physician,
the patient was prescribed ciprofloxacin, even though the physician knew the patient was already taking theophylline. The
patient took the ciprofloxacin prescription to the same community pharmacy that had just dispensed the theophylline a few
days prior. In addition to the computer system alerting the pharmacist of the drug interaction, the pharmacist also later testified
that he was aware of the potentially dangerous drug interaction
between theophylline and ciprofloxacin. When the patient
picked up the ciprofloxacin prescription, he declined the offer to
speak to the pharmacist and was only provided written patient
information that warned in fine print about the potential drug
interaction. During the dispensing and distribution of the
ciprofloxacin the pharmacist never contacted the physician or
orally counseled and warned the patient about the potential drug
interaction.
In a civil malpractice action against the prescribing physician,
community pharmacy, and dispensing pharmacist, the patient
alleged that he sustained injuries caused by the adverse drug interaction between theophylline and ciprofloxacin. The defense
lawyers for the pharmacy and pharmacist requested the court to
dismiss the lawsuit, arguing that the pharmacist had no legal duty
to the patient under the circumstances, and that it was the physician who had the responsibility to either not concomitantly prescribe the medications or to warn the patient of the potential
interaction. The court disagreed and decided the pharmacist was
aware of the patient already taking theophylline when the
ciprofloxacin prescription was filled, and that this posed an
increased danger to the patient. Therefore, with regards to the
pharmacy and pharmacist, the court allowed the civil malpractice
action to proceed.30
This particular case illustrates that in the area of pharmacy
malpractice litigation, the pharmacist’s legal responsibility may
go beyond accurately dispensing prescription medications. In
this case, where a prescribing error occurred, the pharmacist
could have utilized specific medication error reduction strategies that may have prevented patient harm, including acting
upon the computer alert, contacting the prescriber, and/or
counseling the patient about the potential interaction between
the two drugs.
Case 2
A hospital pharmacist received a prescription order for etoposide
with a base solution of 0.9% sodium chloride. A pharmacy technician compounded the prescription using a base solution of
23.4% sodium chloride, and the pharmacist failed to identify the
error and properly label the product with the base solution that
was used. The compounded prescription was administered to a
two-year-old patient who subsequently died as a result of the
medication error. As a result of the incident, the hospital terminated the pharmacist and technician. After being dismissed from
the hospital, the pharmacist obtained employment at a community pharmacy where he was also involved in additional dispensing errors.
The etoposide medication error resulted in the initiation of
all three legal actions: civil, administrative, and criminal.
Although the civil action against the hospital settled out of court,
the pharmacist had administrative and criminal charges to contend with. With respect to the administrative action, the state
board of pharmacy concluded that the multiple dispensing
errors, in both the community and hospital settings, constituted
misbranding and unprofessional conduct by the pharmacist.
These state board of pharmacy regulatory violations, in addition
to the pharmacist’s disturbing demeanor and mental state during
testimony to the board of pharmacy, led the state board to permanently revoke the pharmacist’s license. In addition to the loss
of his pharmacy license, the pharmacist was criminally indicted
(charges still pending) for manslaughter and reckless homicide in
the death of the two-year-old child.31,32
This case exemplifies the devastating consequences that can
result from a single medication error. In addition to demonstrating
how unnecessary patient harm or death can occur, it also illustrates
that one medication error can result in civil, administrative, and
criminal actions for pharmacists.
CONCLUSION
Pharmacists have a vital role in managing and improving each step
of the medication use process. It is imperative for pharmacists to
be familiar with the types and causes of medication errors, as well
as strategies that can be implemented to prevent them. Strategies
that should be utilized include appropriate and enhanced education, medication error reporting, and quality assurance programs
that incorporate national recommendations specific to pharmacy
practice. In particular, by implementing counseling into daily practice, pharmacists can further prevent medication errors and
improve patient safety.
It is also important for pharmacy providers to understand
the potential legal consequences that may arise from medication errors. In addition to civil malpractice actions, pharmacists may also have to contend with administrative and criminal actions. By preventing medication errors, patient safety is
improved and the potential for subsequent legal consequences
is decreased.
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