medication error: a systematic review and …

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Komal et al. World Journal of Pharmacy and Pharmaceutical Sciences
MEDICATION ERROR: A SYSTEMATIC REVIEW AND
COMPARIOSON OF REPORTING SYSTEM IN USA, UK AND INDIA
Komal Baraiya* and Kashyap Thummar
Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad – 382424,
Gujarat, India.
ABSTRACT
An important cause of patient morbidity and mortality, hence it can be
a confusing and underappreciated concept is known as medication
error. Both the national patient safety agency report 2004 (United
kingdom) and the Institute of Medicine report 2000(United State of
America) highlight that medical errors cause a large number of death
each year. As per the Institute of Medicine reports 44,000 to 98,000
deaths to occur yearly due to the medical error and Seven thousand
(7,000) deaths yearly were attributed to medication errors. Estimation
of 237 million medication errors occurs at some point in the
medication process in England per year. 5.2 million Medical error is
happening in India annually. Medication errors are extensively
characterized as any error in the prescribing, dispensing, or administration of a drug. But now
Recently medication error classified by mistakes, slips, and lapses based on the physiological
approach. A medication error may be caused by during manufacturing and drug delivery.
Medication error caused by different factors like lack of knowledge, insufficient staff and
resources, naming and labeling of medicine, poor communication with the patient, physician,
and pharmacist, etc. The reporting system important for the evaluation of the medication
error causes. United State of America and United Kingdom have a separate reporting system
for medication error but India still has no reporting system. Its reduced by new technology
like computerized physician operator entry (CPOE), double check system, avoid the use of
abbreviations, update the knowledge about the new drug and high-risk drug, etc.
KEYWORDS: Medication error, adverse drug event, patient safety, prescription error.
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
SJIF Impact Factor 7.632
Volume 9, Issue 8, 1011-1030 Review Article ISSN 2278 – 4357
Article Received on
08 June 2020,
DOI: 10.20959/wjpps20208-16805
*Corresponding Author
Komal Baraiya
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INTRODUCTION
Since this publication of the landmark Institute of Medicine (IOM) report To Err is Human,
which improves the enhanced focus on the safety of health care. [1]
The complexity of modern
pharmacotherapy lends itself by confusing patients and errors done by health care
professionals. [2]
Both the national patient safety agency report 2004 (UK) and the IOM report
2000(USA) highlight that medical errors cause a large number of death each year. According
to Institute of Medicine (IOM) report 44,000 to 98,000 deaths occur annually due to medical
errors, making medical errors the eighth leading cause of death in the United States. Seven
thousand (7,000) deaths yearly were recognized as medication errors. [3]
Estimation of 237
million medication errors occurs at some point in the medication process in England per
year. [4]
As per the investigation find out the 5.2 million Medical error is happening in India
annually. Due to lack of reporting system and absence of data registration system the exact
number of medication error difficult to find. [5]
The definition of medication error as „A failure
in the treatment process that leads to, or has the potential to lead to, harm to the patient.
Medication errors can happen at any stage of the medication use process and may or may not
lead to an ADE. Depending on the clinical setting, about one-third to one-half of ADEs are
related to medication errors. [3,6]
Medication error definition According to WHO and NCC
MERP "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 healthcare
professional, patient, or consumer. Such events may be related to professional practice,
healthcare products, procedures, and systems, including prescribing; order communication;
product labeling, packaging, and nomenclature; compounding; dispensing; distribution;
administration; education; monitoring; and use.", [7]
Figure 1: Relationship between ADEs, potential ADEs, and medication errors. [3]
www.wjpps.com Vol 9, Issue 8, 2020.
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Classification
monitoring error, dispensing error. But now Recently medication error classified by mistakes,
slips, and lapses based on the physiological approach. It Is also categorized by the National
Coordinating Council for Medication Errors Reporting and Preventions (NCCMERP). The
NCCMERP taxonomy for medication errors defines four broad categories of errors: “No
error”, “error, no harm”, “error, harm” and “error, death”. [8]
Figure 2: Classification of medication errors based on psychological principles. [8]
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Table 1: Types and subtypes of medication errors with examples correlating with
medical-related side effects. [9]
allergy history
Applying a bad
patient department; continuously giving a
loading dose of a medication
Hematoma
writing a prescription beginning with carb,
followed by scribbles
side effects of
the drug which
was unintended to
in the pediatric ward based on weight;
improper blood pressure measurement;
infusion of medication
patient with atrial fibrillation in the
prescription; failure to inform the patient
regarding drug-food interactions in patients
on warfarin
warfarin
Statistics
Patient safety and treatment cost can be significantly affected by the medication error that
result in hazards for patient and their families. Medication errors can lead to adverse
outcomes such as increased mortality, increased duration of hospitalization, and increased
medical expenses. [5]
Both the national patient safety agency report 2004 (UK) and the IOM
report 2000(USA) highlight that medical errors cause a large number of death each year.
According to the report, a medication error is the most common type of error in health care.
According to IOM report prevalence of medication errors in the United States in which at
least 1.5 million Americans are injured and 7,000 deaths, every year by medication errors as
well as 44,000 to 98,000 deaths occur yearly due to medical errors, making medical errors the
eighth leading cause of death in the United States. [3]
As per the U.S. Pharmacopeia 8th
Annual MEDMARX® Report Specifies Look-Alike/Sound-Alike Drugs Lead to Thousands
of Medication Errors Nationwide. [10]
In England estimate the 237 million medication error
occur at some point in the medication process per year. The estimated NHS costs of definitely
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avoidable ADRs are £98.5 million per year, consuming 181,626 bed days, causing 712
deaths, and contributing to 1,708 deaths. 5.2 million Medical error is happening in India
annually. [4]
Figure 3: Medication error by type. [11]
Figure 4: Medication errors according to the class of drugs. [12]
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Figure 5: Risk percentage of individual drug. [11]
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Causes of medication errors
The factors that affect medication error are patient, health care professional, and medication
factors that are associated with the risk of a medication error. [13]
The Commonwealth Fund
International Health Policy survey compared factors associated with patient-reported
medication errors across seven countries. In 11% of patients experiencing a medication error,
risk factors included poor coordination of care, cost-related barriers to medical services or
medicines, multimorbidity and hospitalization Some of the key factors associated with
medication errors, including the Medication factors (eg, similar sounding names, low
therapeutic index), patient factors (eg, poor renal or hepatic function, impaired cognition,
polypharmacy), and health care professional factors (eg, use of abbreviations in prescriptions
and other communications, cognitive biases). Some Consequences faced by physicians after
medication errors that include loss of patient trust, civil actions, criminal charges, and
medical board discipline. [13,14]
Deficiency of therapeutic training
Overworked or tired health care professionals
Physical and emotional health matters
Poor communication between health care professional and with patients
B. Factors associated with patients
Patient features (e.g., personality, literacy and language barriers)
The complexity of the clinical case, including multiple health conditions, polypharmacy,
and high-risk medications
Workload and time pressures
Insufficient resources
Issues with the physical work environment (e.g., lighting, temperature and ventilation)
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D. Factors associated with medicines
Naming of medicines
Labeling and packaging
Repetitive systems for ordering, processing, and authorization
Patient monitoring (dependent on practice, patient, other health care settings, prescriber)
F. Factors associated with computerized information systems
Tough processes for generating first prescriptions (e.g. drug pick lists, default dose
regimens, and missed alerts)
Deficiency of accuracy of patient records
Poor design that allows for human error
Regulations and guidance of medication error
1. United states of america [15]
Guidance for Industry: Safety Considerations for Product Design to Minimize Medication
Errors
Guidance for Industry: Contents of a Complete Submission for the Evaluation of
Proprietary Names
Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs
Draft Guidance for Industry: Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors
Guidance for Industry and FDA Premarket and Design Control Reviewers - Medical
Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human
Factors and Usability Engineering to Optimize Medical Device Design
PDUFA Pilot Project: Proprietary Name Review - Concept Paper
Medication Guides - Adding a Toll-Free Number for Reporting Adverse Events
Resources
Agency for Healthcare Research and Quality: Medical Errors and Patient Safety
Centers for Disease Control and Prevention: Medication Safety
Department of Veterans Affairs National Centre for Patient Safety
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Institute for Safe Medication Practices
National Patient Safety Foundation
To Err is Human: Building a Safer Health System (Institute of Medicine)
Preventing Medication Errors: Quality Chasm Series
National Coordinating Council for Medication Error Reporting and Prevention
Report medication error to FDA Med Watch
Guidance for Industry: Safety Considerations for Product Design to Minimize Medication
Errors Guidance for Industry
From our perspective: Working to prevent proprietary drug name confusion
Computerized Prescriber Order Entry Medication Safety (the )
Update on Phonetic and Orthographic Computer Analysis Tool
2. India [16]
3. UK [17,18]
Good Practice Guidance 10: Handling of medication errors, incidents and near misses in
Care Homes
GMC Good practice in prescribing and managing medicines and devices (2013)
Medication Errors
NICE guideline: Medicines optimization: the safe and Medicines optimization: the safe
and effective use of medicines to enable the best possible outcomes
GPhC Responding to complaints and concerns (2010)
NMC Standards for medicines management (2010)
CQC Fundamental Standards- Regulation 12
Regulation 13 of the Health and Social Care Act 2008 (Regulated Activities) Regulations
2010
NMC Standards for Medicines Management (2007)
NMC the Code, Nursing, and Midwifery Council (2015) and the Code. Professional
Standards of practice and behavior for nurses and midwives
NMC Standards and proficiency for nurse and midwife prescribers
Royal Pharmaceutical Society Medicines, Ethics, and Practice (2016)
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4. Current medication error reporting system
Reform of medicate on error reporting systems will help to prevent easily avoidable mistakes
and their often serious consequences. Pharmacists must learn to detect medication errors,
actual or potential, to understand their causes, and to propose system wide changes to reduce
the risks to patients. [19]
USA and UK having separate reporting system for the medication
error but in India have no reporting system for the medication error. In India Medication error
reporting including in the pharmacovigilance system. [20]
Table 2: Reporting system with country. [20]
Country Reporting system
National Patient Safety Agency (NPSA)
India No reporting system
1. Prescribing error
This is a story of a 73-year-old man with a history of cardiac arrhythmia who is presented in
the clinic for a routine follow-up visit. After when the evaluation was done by his physician,
the patient has received a handwritten prescription for Rythmol 150 mg, which he had been
taking for the previous 3 years. After filling this prescription from the clinical pharmacy and
he subsequently started to experience nausea, sweating, and an irregular heartbeat. After 2
weeks of symptoms, he called his physician for an appointment, noting that his Rythmol
tablets looked different than last time. When evaluated, the physician discovered that the
patient incorrectly received Synthroid (levothyroxine) 150 mcg from the pharmacy instead of
the prescribed Rythmol 150 mg. [21]
Problem: The prescription filled by the pharmacist was attributed because on the
prescription copy there was an error with an unclear handwriting
Prevention
Ensure knowledge before prescribing a drug
Ensure an accurate drug history which is taken
The drug name and patient details should be printed on the prescription
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Include all details of drug therapy i.e. name of drug, dose, directions, and duration of
therapy
Awareness of Look-alike and sound-alike products should be there
Implementing the use of tools for guiding medication prescribing
2. Dispensing error
A history of a 65-year-old female patient with an obstructive airway disease was seen by her
general practitioner, an oral penicillin product was prescribed and for seven days
prednisolone, 40 mg daily is also prescribed. The miss-selection was done by the community
pharmacist of a 28-day patient pack of propranolol 40 mg tablets instead of prednisolone 5
mg tablets and the pack was labeled with propranolol which a dispensing label with
instructions that to take eight tablets daily. The supplied was done by the same manufacturer
with both the prednisolone and propranolol tablet packs and the similarity of labeling and
packaging of the two products was the same in appearance. The first dose is taken by the
patient and soon afterward she had difficulty in breathing, she became hypotensive and lost
her consciousness. She rushed to the hospital where she can subsequently die. [21]
Problem: For the prednisolone tablets the pharmacist miss-selected the propranolol.
Prevention
Every medicine should be cross-checked before dispensing it
A safe dispensing procedure should be ensured
Always use different brands or separating Lookalike and Sound alike products
At a safe and manageable level workload must be maintained
Be aware of high-risk drugs (HAM) e.g. Hypertonic Electrolytes (Potassium chloride,
Calcium chloride, Magnesium Sulphate), cytotoxic agents, IV Insulin
Good housekeeping practices can be introduced
Keep the storage area well organized
Different products should have a unique packaging and labeling system
3. Administration error
In the following traffic accident, a patient was admitted. He had sustained bilateral lower
limb fractures but was recovering well. The cardiac arrest followed with other symptoms and
also consistent with a large pulmonary embolus, the patient was resuscitated long enough and
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was enable him to be transferred to a critical care unit but afterward with a despite intensified
treatment he died shortly. In his drug chart, the prophylactic heparin injections were not
signed which are being administered to him on several occasions. What constitutes a
medicine administration error (MAE) varies from study to study that make comparisons
difficult? Some studies include time errors: for example, one hour earlier or later the
medicine was given for which it was prescribed for, while other studies ignore them. [21]
Problem: wrong administration of heparin in the wrong time
Prevention
Proper administration of the right medication at the right time
Medication Administration Record (MAR) properly maintain
Do a cross-check before giving any medicine
Check the patients identity before administered any medicine
Provide educational session about good medication administration practices
Barcoded medication administration (BCMA) systems
4. Monitoring error
An emergency admission came to the hospital of a 42-year old male patient with lithium
toxicity. Unfortunately, his blood lithium levels were outdated. The last level that has been
recorded (5 months earlier) was inside the therapeutic range; hence his oral lithium
prescription was re-authorized. The two most recent outpatient appointments of his have been
canceled and his lithium levels were not regularly being monitored. At the time of reporting,
the patient was being ventilated. [21]
Problem: The lithium levels were not regularly being monitored
Prevention
The patients medication administration record should be regularly monitored
If you have the prescription, the drug and the patient in the same place so that they can be
checked against one another
Ensure that the medication is given at the correct time
Medication error prevention
The medication errors are diverse because of the root causes, multiple strategies are required
to prevent them. Campaigns such as the “5 Rights of Medication Administration “right drug,
right patient, right dose, right route, right time-have been used with limited success. [22]
The
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approaching system first of all requires improving medication safety and then reducing
medication errors. Strategies are employed which include using clinical pharmacists,
computer technology and educational programs, often within multifaceted interventions.
Most important interventions have been conducted in individual countries and may not be
generalizable to other countries where the health service structure is different, or where there
are different levels of availability of services (e.g. pharmacists) or technology (e.g.
computerized provider order entry). For over-the-counter medications, the FDA has also
worked to standardize labels to make them easier for patients to read. [14]
Medication reviews and reconciliation
The process of a patients medicine evaluation to improve the health outcomes and mitigate
drug-related problems is known as Medication review. Primary care interventions are
designed to reduce medication-related adverse events that is found in the most successful
interventions which include a medication review which is conducted by a pharmacist or other
clinicians, or focused on multi-component interventions, by a primary care professional
medication is reviewed as one component. The formal process of establishing and
documenting a consistent, definitive list of medicines across transitions of care and then
rectifying any discrepancies is known as Medication reconciliation. Some medicines have
been tested for the reconciliation system. These new medication systems deal with changes,
deletions, and additions following hospital admissions. These systems reduced medication
discrepancies found in the systematic review, as well as potential and actual adverse drug
events. [14]
Medication reconciliation is a process that involves (1) verification of the patients
medication history, (2) clarification that the medications are appropriate for the patient, and
(3) reconciliation of any discrepancies. [23]
Automated information systems
Computerized provider order entry (CPOE) with the decision support that may be effective
and if targeted at a limited number of potentially inappropriate medications which is designed
to reduce the alert burden by focusing on clinically-relevant warnings. To decrease the
frequency of medication error in the in-patient setting there is substantial evidence that
supports the use of CPOE. When an order was processed via CPOE the error occurrence was
decreased by 48%. However, there is additional research that is needed to link a decrease in
medication errors and patient harm. [14,24]
Barcoded medication administration (BCMA)
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systems require that the nurse who administers the medication at the bedside should scan the
patient's identification bracelet and the unit dose of the medication being administered. [25]
Education
The health care providers should be educated which is a key element to improve safety in
primary care. This holds medication errors which are reduced where education is often a part
of multicomponent interventions. In the educational interventions the improvement in the
prescription and dispensing of antibiotics that may impact on clinician behavior with
improved adherence to guidelines. The personal health records held by the patient often had a
positive effect on health outcomes, although there was the potential for a negative impact on
equity. [14]
Real-time education by pharmacists may also decrease errors. Pharmacist
participation as a full member of a health care team on hospital rounds also is reported to
decrease adverse drug events caused by prescribing errors. [26]
Multicomponent interventions
More than one intervention many studies were included. For improving the medication
practices evidence supports the use of multifaceted approaches. An inappropriate prescription
and the number of adverse drug events should be reduced. A study is to assess the progress in
improving the use of medicines reviewed by the empirical evidence and examined
ambulatory in primary care practices in 104 low- and middle-income countries. Complex
interventions, employing education, provide supervision, and community case management
strategies appeared are most effective. [14]
Example of medication error with prevention [22,27,28]
Unapproved abbreviations and illegible handwriting (for example, the U for units could be
confused for a zero; trailing zeros after a decimal could be mistaken for 20 rather than 2.0;
QD [every day] could be confused with QOD [every other day] or QID [4 times a day]).
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Table 3: List of abbreviations.
Abbreviations Intended Meaning Misinterpretation Suggested Practice
D/C Discharge or
D/C (intended to mean discharge) was
interpreted as discontinued when
Use "discharge" and
μ g microgram Mistaken for "mg" when handwritten Use "mcg"
q.d. or QD Every day Mistaken as q.i.d. (four times a day) Use "daily" or "every day"
q.o.d. or QOD Every other day Misinterpreted as q.d. (daily) or q.i.d.
(four times a day) Use "every other day"
Sub q Subcutaneous The "q" has been mistaken for "every" Use "subcutaneous"
U or u Unit Read as a zero (O) or a four (4), causing
a 10-fold overdose Use "unit"
Look-alike bottles should be placed in separate locations in a pharmacy and same strength
product labelling should be differentiate by giving the different color of strength (see figure.
Figure 6: Look-alike labels and labeling.
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Figure 7: Product Strength – Differentiation.
Figure 8: Look-alike & sound-alike names.
Similar sounding medications such as glyburide and glipizide can be labeled with “tall man
lettering” to decrease medication error.
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Table 4: Tall man lettering list.
Established Name Recommended Name Established Name Recommended Name
Acetohexamide
Acetazolamide
acetoHEXAMIDE
acetaZOLAMIDE
Medroxyprogesterone
Methylprednisolone
Methyltestosterone
MedroxyPROGESTERone
methylPREDNISolone
methylTESTOSTERone
Bupropion
Buspirone
buPROPion
busPIRone
Methylprednisolone
Methyltestosterone
methylPREDNISolone
methylTESTOSTERone
Chlorpromazine
Chlorpropamide
chlorproMAZINE
chlorproPAMIDE
Migalastat
Miglustat
migALAstat
migLUstat
Cisplatin
Carboplatin
CISplatin
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CONCLUSION
Medication errors are becoming a major threat to patients safety. They lead to increased
morbidity and mortality rates, cost of treatment. Medication errors occur in all healthcare
systems with a combination of human factors and process issues. Eliminating all sources of
error is very difficult. Therefore identifying the causes of medication errors and developing
need-based strategies viz. medication error reporting system is important for identifying and
analyzing the causes of medication error. USA and UK have separate reporting system but in
India still have no reporting system for the medication error. Educational and incorporating
new information technologies in the existing healthcare system may help prevent medication
errors. All healthcare professionals have a responsibility in identifying contributing factors to
medication errors and to use that information to further reduce their occurrence. Minimizing
risks is feasible, and usually cost-effective. Care should be taken to ensure that the
medication is given safely and securely, by checking 3 things, MAR (Medication
Administration Record), doctors orders and pharmacy label.
ACKNOWLEDGMENT
The Author and co-author, thanks to the graduate school of pharmacy for providing the
necessary facility to accomplish the work.
CONFLICT OF INTEREST
The authors confirm that this article's content has no conflicts of interest.
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