MedDRA®
POINTS TO CONSIDERCOMPANION DOCUMENT
ICH-Endorsed Guide for MedDRA Users
Release 1.0
June 2018
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Table of Contents

SECTION 1 – INTRODUCTION .......................................................................................... 1
SECTION 2 – DATA QUALITY ........................................................................................... 2
2.1 The Importance of Data Quality ............................................................................. 2
2.2 Characteristics of Good Quality Data .................................................................... 3
2.3 The Role of MedDRA in a Data Quality Strategy ................................................... 3
2.4 Components of an Organisational Data Quality Strategy ...................................... 3
2.4.1

Data collection ............................................................................................ 3

2.4.2

MedDRA coding considerations.................................................................. 5

2.4.3

Training ....................................................................................................... 7

2.4.4

Quality assurance checks ........................................................................... 8

2.4.5

MedDRA versioning strategy ...................................................................... 9

SECTION 3 – MEDICATION ERRORS ............................................................................ 10
3.1 Coding Medication Errors – Questions and Answers .......................................... 11
3.1.1

Use of LLT Medication error ..................................................................... 11

3.1.2

Selecting more than one term ................................................................... 11

3.1.3

Medication error vs. off label use .............................................................. 12

3.1.4

Potential medication errors ....................................................................... 12

3.1.5

Selecting the most specific term ............................................................... 12

3.1.6

MedDRA Concept Description for medication error .................................. 13

3.1.7

Stages of the medication use system ....................................................... 14

3.1.8

Coding the root cause ............................................................................... 14

3.1.9

Do not infer a medication error ................................................................. 14

3.1.10 Device use error vs. device malfunction ................................................... 15
3.2 Examples for Coding Medication Errors .............................................................. 15
3.2.1

Accidental exposures to products ............................................................. 16

3.2.2

Miscellaneous medication errors/issues ................................................... 17

3.2.3

Product administration errors/issues......................................................... 20

3.2.4

Product confusion errors/issues................................................................ 24i3.2.5

Dispensing errors/issues........................................................................... 25

3.2.6

Monitoring errors/issues............................................................................ 26

3.2.7

Preparation errors/issues .......................................................................... 28

3.2.8

Prescribing errors/issues .......................................................................... 29

3.2.9

Product selection errors/issues ................................................................. 31

3.2.10 Product storage errors/issues ................................................................... 31
3.2.11 Product transcribing errors/communication issues ................................... 33ii

SECTION 1 – INTRODUCTION
The MedDRA Term Selection: Points to Consider and MedDRA Data Retrieval and
Presentation: Points to Consider documents provide valuable guidance to MedDRA
users worldwide on general term selection and data retrieval principles as well as
providing specific examples of approaches to coding and analysis. However, there arecertain topics where users could benefit from having more detailed information
pertaining to the use of MedDRA than can be covered in the existing documents.
The purpose of this Companion Document is to supplement the Points to Consider (PtC)
documents by providing additional details, examples, and guidance on specific
MedDRA-related topics of global regulatory importance. It was developed and ismaintained by the same working group that was charged by the ICH Management
Committee to develop the PtC documents. The working group consists ofrepresentatives of ICH regulatory and industry members, the World Health Organization,
the MedDRA Maintenance and Support Services Organization (MSSO), and theJapanese Maintenance Organization (JMO).
The Companion Document is intended to be a “living” document and is updated basedon users’ needs, rather than being tied to the biannual update of the PtC documents thatis performed with each MedDRA release. Like the PtC documents, the Companion
Document is available in English and Japanese; however, if certain examples are not
relevant or are difficult to translate, these will not be included in the Japanese version.
The contents of the document are agreed by all ICH parties; it does not specify
regulatory requirements, nor does it address database issues. Organisations areencouraged to document their own coding and data retrieval conventions inorganisation-specific guidelines which should be consistent with the PtC documents andthis Companion Document.
Users are invited to contact the MSSO Help Desk with any questions or comments about
the MedDRA Points to Consider Companion Document.

1

SECTION 2 – DATA QUALITY
This section will discuss important data quality and data entry principles related to theuse of MedDRA in the clinical trial and postmarketing environments. It will not address
specific regulatory requirements, database structure issues, file format conventions, data
workflow applications, or other topics which are beyond the scope of MedDRA.
In both the development and marketing of human medicinal products, data collection is a
critical and ongoing process. As noted in the MedDRA Term Selection: Points toConsider (MTS:PTC) document, the quality of original reported information directly
impacts the quality of data output.

High Quality
Data Input

High Quality
Data Output

Data are applied to make inferences, test hypotheses, draw conclusions, makestatements, and report findings about the safety and efficacy of biopharmaceuticalproducts. Since data are used for activities ranging from coding to information
categorisation, retrieval, analysis, and presentation, ensuring access to high quality datais paramount. Quality data support safety functions including signal detection, data
analysis, and product label development. This section will describe some of the practices
and processes which should be part of an organisational data quality strategy.
2.1

The Importance of Data Quality
As the regulated biopharmaceutical industry strives for greater harmonisation of safety
reporting regulations and standards, there is an increasing emphasis on safetysurveillance and data quality. In addition to supporting patient/subject safety, increased
data quality facilitates communication of complete and accurate information to those
involved in clinical research and post-marketing processes (including regulatory bodies,sponsoring companies, study site personnel and marketing authorisation holders).
Collection of high quality data can also result in greater time and cost efficiency during
product development and marketing (e.g. less querying of incomplete data, decreasesite monitoring costs and reduce the risk of delayed regulatory approval).
The quality of adverse event data is central to safety monitoring in clinical trials, to therisk assessment of marketing applications and in the evaluation of safety signals withinpostmarketing data. Adverse events are typically generated by complaints from study
subjects, patients or their caregivers. These verbatim terms may be either coded
manually or coded automatically with autoencoder tools by selecting MedDRA Lowest
Level Terms (LLTs). Users need to be aware that some LLTs are rather non-specifc andthat further clarification of the reported information may be necessary. Small deviations
in coding can result in significant issues and produce misleading analyses. Coding
selections may vary even in apparently simple cases.Given this variability, it is importantto thoughtfully evaluate adverse event data rather than relying on any specificrecommendation or guidance.
22.2

Characteristics of Good Quality Data
Quality data have several common features. Foremost, these data should be bothcomplete and accurate. Whenever possible, the most concise form of data should becollected, provided that this can be done without sacrificing either completeness or
accuracy. Within an organisation, data quality is fostered by comprehensive, consistent,transparent and documented data handling processes. Quality data is, by definition,
supported by the available information. For example, clinical diagnoses should beconsistent with the available medical history, physical findings, laboratory andinvestigational results. Furthermore, quality data should be capable, when appropriate,of supporting data-related associations (e.g. when performing a causality assessment ofan adverse event which could be related to a product).

2.3

The Role of MedDRA in a Data Quality Strategy
As a standardised and validated clinical terminology used in both clinical development
and postmarketing surveillance, MedDRA should play an important role in a sound data
quality strategy. Since MedDRA is used to “code” information during data entry, it isimportant to consider the principles in the MTS:PTC document to ensure the selection ofcoding terms with the highest specificity and analytical quality. The large number ofavailable LLTs provides a high degree of granularity. However, even the granularity of
MedDRA cannot overcome “low quality” primary information.

2.4

Components of an Organisational Data Quality Strategy
The development and implementation of an organisational data quality strategy is acomplex task which involves the input, support and collaboration of many stakeholders.
Many of the principles of high quality data collection are the same in both the clinical trial
and postmarketing environments. This section will discuss a framework for acquiring
data of high quality.
2.4.1 Data collection
Whether in a clinical trial, a postmarketing safety call center, or a healthcare
professional’s office, there is often only one opportunity to capture complete andaccurate information. Since data output quality is determined by data input quality in a
database, there are important consequences from these initial steps. For thosecollecting information (e.g. a study site physician/nurse, a postmarketing call center
employee, a dispensing pharmacist, an emergency room physician), certain practices
will help to maximise the quality of the collected data:•

During data collection, completeness and accuracy need to be weighed against
the risk of collecting “unimportant” information. This is particularly true if time
limitations are present. It is advisable to minimise the amount of unimportant
information placed in dedicated data fields for key concepts such as adverse
events. Otherwise, the data coding and management can be further complicated.

•

In clinical trials, reporters should be encouraged to use consistent medical
terminology to describe similar medical concepts. The best strategy is to carefully3

train study site personnel (especially investigators) about the importance ofconsistency in data collection.
•

In clinical trials, data collection instruments (whether they are electronic or papercase report forms) should be carefully designed to be easy to use, enduring andsufficiently comprehensive to gather all the necessary information. Since
individual trials or clinical projects can span years, it is never possible to spend“too much” time developing quality data collection tools. Appropriate “subject
matter experts” in data management, information technology, statistics, quality
assurance, and regulatory compliance should be involved throughout theplanning process. After years into development, it is difficult, if not impossible, tocompensate for needed data which has not been adequately collected.

•

With the passage of time, the ability to seek clarification of incomplete
information becomes limited and very often, a reporter’s recollection of important
facts can change dramatically. Therefore, it is crucial to start the “query” process
as soon as possible to obtain clarification from the data source.

•

When a report contains multiple diagnoses (such as a report of “broken finger
and hand abrasion” or “urinary bladder obstruction and cystitis”), it is usually
appropriate to record these as separate concepts on the data collection form•

Attempt to minimise spelling errors and the use of abbreviations and acronyms.
The table below illustrates the difficulty of interpreting such poor or ambiguous
data:

•

Reported

Data Quality Challenge

Had MI

Does MI stand for myocardial infarction,
mitral insufficiency, mental illness ormesenteric ischaemia?

Interperial

Was this word intended to represent“intraperitoneal” or “intraperineal”?

Nitro drip

Did this drip contain nitroglycerin or
nitroprusside?

Furthermore, without proper context, it is impossible to interpret other “vague”
terms as shown in the table below:

4Reported

Data Quality Challenge

Congestion

Nasal, hepatic, venous, etc.?

Obstruction

Bronchial, intestinal, ureteral, etc.?

Infarction

Myocardial, cerebral, retinal, etc.?

Clarification of such terms should be requested at the time of data collection. If
clarification cannot be obtained, it is sometimes helpful to append terms such as“unknown” or “unspecified” to the reported information so that it is clear that theappropriate questions were asked.
2.4.2 MedDRA coding considerations
MedDRA can be used to accurately code many types of reported information. This
includes not only diagnoses, signs and symptoms representing adverse
reactions/adverse events but also concepts such as medical and social history,
indications for product use, device-related events, surgical and medical procedures,investigations, exposures, misuse and abuse, off label use, medication errors, andproduct quality issues. For meaningful data review, it is important to ensure that all
required information is coded consistently. Important data quality issues to consider
include:•Steps should be taken to ensure that individuals responsible for MedDRA coding
have familiarity with the terminology as well as the requisite training to utilise it
effectively. Particular attention should be paid to the relevant coding principles
outlined in the MTS:PTC document. In environments where MedDRA coding is
performed by a number of individuals, it is important to have a consistentorganisational approach.

•Appropriately trained individuals should review MedDRA coding•

It is an important concept that all adverse events and adverse reactions from areport should be coded, regardless of causal association. Similarly, do not add
information by selecting a term for a diagnosis if only signs or symptoms arereported (MTS:PTC Section 2.10)•

It is important that reported information is coded accurately; it is not appropriate
to select terms for concepts which are less specific or less severe than thereported term (e.g., coding a convulsive seizure with LLT Shakiness or coding
peritonitis with LLT Belly ache)•

It is advisable to follow the “preferred” coding options specified in the MTS:PTC
document, especially for issues like the coding of provisional and definitive
diagnoses with associated signs and symptoms. If one chooses to use an“alternate” coding option from the MTS:PTC, it is a good practice to document
why this was done and to be consistent in the use of this alternate choice.
5•

It is important to distinguish medical conditions (typically found in the SOC of the
primary manifestation site) from laboratory and test terms (which are found in
SOC Investigations)•Verbatim terms may contain more than one medical concept (such as a report of“fall and contusion”). It is important to consider each of the reported events andcode as appropriate.

•

Consider the use of “split coding” (selecting more than one term) where there isno single LLT within MedDRA which captures all of the concepts (MTS:PTC
Section 2.8 and Section 3.5.4)•

Organisations may wish to create “synonym” lists of verbatim terms which canthen be coded to pre-determined LLTs. An example of a synonym list is shown
below:
Reported Verbatim
Throbbing above temple
Aching all over head
Pulsing pain in head

LLT

In a synonym list, each of these verbatim
reports would be coded using LLT Headache

Synonym lists may be particularly helpful in some circumstances, e.g. when those
involved in report coding have limited medical expertise, when coding is in several
geographical sites or when an autoencoder is being extensively used. It is also important
to ensure that terms selected for a synonym are true synonyms for the coded medical
concept.
•

Medical and surgical procedures are generally not adverse events. However, if
only a procedure is reported, then an appropriate term is used to code theprocedure (MTS:PTC Section 3.13.1). On the other hand, if a procedure isreported with a diagnosis, then the preferred option is to select an appropriate
term to code both the procedure and diagnosis. The alternate option is to code
only the reported diagnosis (MTS:PTC Section 3.13.2). Some organisations havedata collection forms with separate data fields for adverse events and forprocedures; this aids entry of data in the appropriate category.

•In the context of safety reporting, death, disability and hospitalisation areoutcomes, not adverse events. Therefore, they are generally not coded with
MedDRA. Instead, they are recorded in the appropriate data collection field foroutcomes. One exception to this recommendation is when death, disability, or
hospitalisation is the only reported verbatim. These concepts are coded with
MedDRA while clarification of the underlying cause is sought (see MTS:PTC
Section 3.2 for further information). In addition, death terms that add important6

clinical information (e.g. LLT Sudden unexplained death in epilepsy, LLT Foetal
death) should be selected along with any reported ARs/AEs.
•

When vague, ambiguous, or conflicting information is reported, MedDRA has
codes which can be utilised while attempts are made to clarify the information.
For example:

Vague information (see also MTS:PTC Section 3.4.3):
ReportedAppeared red

LLT Selected

Unevaluable event

Comment“Appeared red” reported
alone is vague; this could
refer to a patient’s
appearance or even thatof a product (i.e., a pill, asolution, etc.)

Ambiguous Information (see also MTS:PTC Section 3.4.2):
Reported

Patient had medical historyof AR

LLT Selected

Ill-defined disorder

Comment
It is not known what medical
condition the patient had(aortic regurgitation, arterial
restenosis, allergic rhinitis?),so LLT Ill-defined disordercan be selected

Conflicting Information (See also MTS:PTC Section 3.4.1):
Reported

Severe anaemia with ahaemoglobin of 19.1 g/dL

LLT Selected

Haemoglobin abnormal

Comment
LLT Haemoglobin
abnormal covers both of
the reported concepts(note: haemoglobin valueof 19.2 g/dL is a highresult, not a low result as
would be expected insevere anaemia

2.4.3 Training
Appropriate ongoing training is a key part of a good data quality strategy. Training
should be given to all persons involved in the collection, transcription, categorisation,
entry, coding, and review of information. Organisational training practices andprocedures should be documented in writing and continually reviewed for updates.
7

Training should be performed by appropriately qualified individuals who areknowledgeable about the organisation’s standardised procedures and focused oncompliance. Cross-training of key functions is advisable to ensure a consistent approachand to preserve data quality standards during periods of unexpected personnel changes.
Given that organisations may commonly use unfamiliar or remote study sites for clinical
trial conduct, it is also important to ensure that study site personnel (e.g., investigators,
study nurses, clinical study coordinators, clinical research associates, site pharmacists)
are well trained in all relevant aspects of clinical trial conduct including:•Correct use of the assigned data collection instruments•

Training in appropriate techniques for interviewing of study subjects/patients [e.g.
the use of non-directed questioning, reporting of adverse events as diagnoses(when possible) rather than lists of signs and symptoms, precautions to avoid
unblinding]•Knowledge of relevant regulatory considerations related to quality data collection•

Adequate knowledge of the use of MedDRA for coding purposes, as applicable.
This is particularly important for concepts such as coding of definitive versus
provisional diagnoses (with or without symptoms) and not inferring diagnoses•

A thorough understanding of and compliance with an organisation’s agreed-upon“data query” process to clarify information

The “Data Quality, Coding and MedDRA” presentation in the ‘General/Basics’ section of
the “Training Materials” page of the MedDRA website (https://www.meddra.org/trainingmaterials) is another useful resource. This customisable slide set is intended for use atinvestigator meetings and for training personnel involved with data collection (such as
clinical research associates and clinical coordinators). It provides an overview of theimportance and benefits of good quality data as it relates to MedDRA.
2.4.4 Quality assurance checks
A thoughtful and thorough quality assurance (QA) process supports the goal of
maximising data quality. QA checks during the data management process ensurecompliance with established organisational procedures and metrics. Examples of
inaccurate MedDRA coding which QA checks could identify include:8

Reported

Allergic to CAT scan

Feels pressure in eye

Inaccurately
Selected LLTAllergic to cats

Intraocular pressure

QA Review Outcome
This inaccurate LLT was selected byan autoencoder which matched thewords “Allergic to CAT scan” fromthe reported termThis inaccurate LLT refers to thename of the test for intraocularpressure; the appropriate term toreflect the symptom being describedin the report would be LLT Sensationof pressure in eye

These checks can identify coding errors with MedDRA before the database is locked
and erroneous data become part of a data analysis.
The MSSO-maintained Unqualified Test Name Term List is a comprehensive collectionof all unqualified test name terms at the Preferred Term (PT) and Lowest Level Term
(LLT) levels in SOC Investigations. The Unqualified Test Name Term List can be foundon the “Support Documentation” page on the MedDRA website. It may be applied byregulatory authorities and industry as a QA check of data quality in clinical trial andpharmacovigilance databases. Test name terms without qualifiers (e.g., LLT Blood
glucose, LLT CAT scan) do not represent ARs/AEs but are intended to point to an actual
value in a specific database field. For example, in the section for Results of Tests andProcedures in the ICH E2B ICSR electronic transmission standard, unqualified terms
may be used in the data element capturing the test name. Unqualified Test Name terms
are not intended for use in other data fields capturing information such as ARs/AEs. The
Unqualified Test Name Term List is intended as a recommendation only, providing astandard tool for checking coding quality.
2.4.5 MedDRA versioning strategy
Given the twice-yearly releases of new MedDRA versions, organisations should have a
documented versioning strategy to address these updates. The MSSO has created aBest Practice document which contains sections entitled “Recommendations for
MedDRA Implementation and Versioning for Clinical Trials” and “Recommendations forSingle Case Reporting Using Semi-annual Version Control”. This document is found on
the “Support Documentation” page on the MedDRA website.
In addition, the MSSO has provided a MedDRA Version Analysis Tool (MVAT) whichfacilitates the identification and understanding of the impact of changes between any two
MedDRA versions, including non-consecutive ones (see the “Tools” Page on the
MedDRA website).

9

SECTION 3 – MEDICATION ERRORSThe purpose of this section is to expand on the section on medication errors in the
MedDRA Term Selection: Points to Consider (MTS:PTC) document and provides
guidance on scenarios that are medication errors as well as scenarios that are not
medication errors. Additionally, guidance and examples of coding of some scenarios areprovided. This section has two main sub-sections; the first sub-section provides answers
to commonly asked questions about coding medication errors. The second sub-section
provides examples for coding medication errors. Examples are based on MedDRA
Version 21.0.
The document is a living document and the content of this section will be updated basedon user feedback. Users are invited to contact the MSSO Help Desk with any questions
or comments about the MedDRA Points to Consider Companion Document.
Acknowledgments
The PtC Working Group would like to acknowledge the significant contributions of thefollowing individuals to this section of the Companion Document:
Georgia Paraskevakos, Patient Safety Specialist, Health Canada.
Jo Wyeth, Postmarket Safety Program Lead, FDA CDER, OSE, Division of Medication
Error Prevention and Analysis (DMEPA).
BackgroundFor coding purposes, terms that reflect medication errors are grouped in the High Level
Group Term (HLGT) Medication errors and other product use errors and issues (fromMedDRA Version 20.0 onwards). However, terms located elsewhere in the MedDRA
hierarchy can also be used to code cases describing medication errors. To aid data
retrieval of the widely dispersed coding terms, the Standardised MedDRA Query (SMQ)
Medication errors was developed, with a narrow and a broad scope, as a tool forstandardised retrieval of suspected medication error cases.
The HLGT Medication errors and other product use errors and issues contains
numerous Preferred Terms (PTs):
•
•
•
•
•

Types of errors (e.g., PT Wrong drug),Terms combining the type of error with a stage of the medication use system(e.g., PT Drug prescribing error)
Describing the potential for error,
Intercepted errors that did not reach the patient
Uncertainty as to whether the reported incident is an error

Each PT is grouped into one of the High Level Terms (HLTs), either for accidental
exposures, stages of the medication use system*, product confusion, or the HLTgrouping for various other PTs not elsewhere classified.
10

*For the purposes of this document, the medication use system encompasses acontinuum of activities during which a medication error can occur, including
procurement, storage, prescribing, transcribing, selecting, preparing, dispensing,administering, and monitoring. The medication use system excludes activities related tothe entire manufacturing process including manufacturer distribution and storage.
3.1

Coding Medication Errors – Questions and Answers
This sub-section provides answers to commonly asked questions about coding
medication errors.
3.1.1 Use of LLT Medication error
When is it acceptable to use the Lowest Level Term (LLT) Medication error? Can
the term be selected if there is no appropriate MedDRA term for the error?
•

The use of LLT Medication error should be avoided unless there is NO
other information reported about the medication error•

Check all the LLTs in HLGT Medication errors and other product use
errors and issues for the most specific term possible•

If a specific error is reported but no suitable LLT is available, theprocedure for a change request should be followed (see the Change
Requests page on the MedDRA website). In the interim, select the closest
available term to code the reported error. There may be rare instances
when LLT Medication error is the closest term and can be selected.

3.1.2 Selecting more than one term
Should terms for all reported errors related to the same incident be selected?
Sometimes the ‘originating error’ (also referred to as the initial error) results inconsequent errors. For example, it was reported that “a prescribing error for the wrong
drug consequently resulted in the wrong drug being dispensed and administered.”•The ‘originating’ error should be coded as the priority. Additional or‘consequent’ errors can be coded if they are stated in the report. In theabove example, the priority is to code LLT Wrong drug prescribed; LLTWrong drug dispensed and LLT Wrong drug administered are terms forconsequent errors and can also be added.

•

Avoid ‘double coding’ the same error. In other words, do not use multiple
LLTs to capture a singular error that is reported with both a general and a
specific verbatim; code only the specific error. For example, if it isreported that there was an administration error in that the wrong drug wasadministered, select only LLT Wrong drug administered for the specificerror. Do not use an additional LLT Drug administration error for thegeneral description because this would not add any meaningful11information (even though the two LLTs are linked to different PTs).
•

Bear in mind that some organisations will have their database configured
in a way that counts at LLT level and therefore if two LLTs which map to
the same PT are used this may impact on signal detection.

3.1.3 Medication error vs. off label use
It is reported that “a prescriber ordered a much higher dose than per label”, but it
is not stated if this was a mistake or off label use; should terms for both
possibilities be selected, as in differential diagnoses?
•

Do not double code a singular event by selecting a term for an error and aterm for off label use when neither is stated but both are possible; thisapproach is not helpful.

•

When a scenario is unclear, try to obtain clarification; if still unknown,
select the most applicable term for what is reported without inferring what
is not reported. For example, if it is only reported that Drug X wasprescribed at a much higher dose than per label (no information that it
was in error or off label use), select LLT Prescribed overdose (HLT
Overdoses NEC).

•

Off-label use should be coded only when stated.

3.1.4 Potential medication errors
How should terms be selected for reports that describe the potential for error?
For example, a report stated that ‘two drug labels look alike and could result in someone
getting the wrong drug’.
•

Potential errors should be designated as such by selecting the LLTCircumstance or information capable of leading to medication error or LLT
Circumstance or information capable of leading to device use error.

•

Also, select terms that represent information about the error that could
potentially occur. For the above example, select three terms:ooo

For the potential error (LLT Circumstance or information
capable of leading to medication error)
For the contributing scenario (LLT Drug label look-alike)
For the type of error that could occur (LLT Wrong drug)

3.1.5 Selecting the most specific term
How should terms that have overlapping concepts with other terms be used?
For example, a report described a patient who did not allow a product adequate time toreconstitute before self-administering.
12•The most specific available LLT should be selected for the reported
information. For the above example, select LLT Inappropriate
reconstitution technique (PT Product preparation error) because it is more
specific than LLT Wrong technique in product usage process (PT Wrongtechnique in product usage process). Coding a singular error by selecting
two error terms is useful only when this provides meaningful additional
information, i.e. when the single LLT cannot describe the entire reported
scenario.

3.1.6 MedDRA Concept Description for medication error
Does the MedDRA Concept Description for medication error include abuse,misuse, or off label uses?
The MedDRA Concept Description for medication error is as follows:
Medication errors are defined as any preventable event that may cause or lead toinappropriate medication use or patient harm while the medication is in the control of thehealth care professional, patient or consumer. Such events may be related toprofessional practice, health care products, procedures and systems, including
prescribing, order communication, product labeling, packaging and nomenclature,compounding, dispensing, distribution, administration, education, monitoring and use.
National Coordinating Council for Medication Error Reporting and Prevention (US);2001. About medication errors. https://www.nccmerp.org/about-medication-errors.
Accessed December 1, 2017.
•

As a general principle, intentional uses such as abuse, intentional misuse, offlabel use, and intentional overdose are not medication errors. However,whether a scenario is an error or not may depend on the reason or cause.
For example:o If confusion with some aspect of the product causes or results inincorrect product use or misuse (e.g. the device was confusing so
the person administered an extra dose to make sure he got a fulldose), it would usually be considered an error, and not intentional
misuse•oOccurrence of an adverse drug reaction (ADR) may cause thepatient to stop therapy; this is usually classified as therapy
cessation, not intentional misuse or an erroroPatient may decide to take their medication less frequently thanprescribed; this is usually classified as intentional misuse, not a
medication error

Drug abuse and details describing how the drug is abused (route ofadministration, preparation) do not constitute medication errors
13•

Note that situations such as product quality or product supply issues outside
one’s control are also not usually classified as medication errors, but can
result in medication errors. For example, device malfunction or packaging
defect (product quality issues) can result in an incorrect dose administered.

3.1.7 Stages of the medication use system
When is it appropriate to use a medication error term without the stage of the
medication use system?
Some MedDRA terms have both the type of error and stage of the medication use
system (e.g., LLT Wrong drug prescribed); some terms have only the type of error (e.g.,
LLT Wrong drug); and some terms have only the stage (e.g., LLT Drug prescribing
error).
•

Using a single LLT

For example, a report stated that ‘the pharmacy dispensed the wrong drug’. It is
important to highlight both the stage and the type of error where it is known. In thisexample, this is possible using a single LLT Wrong drug dispensed (instead of two LLTs:
LLT Wrong drug and LLT Wrong drug dispensed).
•Using more than one LLT

For example, a report of ‘administered the wrong strength’ should be coded with LLTWrong strength and LLT Drug administration error because no available single term
captures the reported information in full.
If the stage is not known, there are terms for the type of error only, such as LLT Wrongdrug, LLT Wrong schedule, LLT Wrong strength, etc.
3.1.8 Coding the root cause
Is it recommended to code the root cause if stated in the case report?
When the root cause is provided, select a term for the root cause if possible because
root causes are critical to understanding why an error occurred and identifying
interventions that can be undertaken to prevent the error.
•

For example, a product quality issue may lead to a medication error; in such acase, the product quality issue is the root cause of the error. Select terms forboth the quality issue and the error.

•

For the broader patient safety concepts, the root cause may not be
represented in MedDRA and should be documented in free text (e.g.
narrative field) if known. These involve issues such as human factors (stress,
fatigue) or system issues (training/education).

3.1.9 Do not infer a medication error
Is it acceptable to use specific medication error codes for information not
explicitly stated in the case report?
14

For example, the report that only stated ‘The nurse administered 50 mg of Drug X’. Twocoders had different opinions:••

One coder selected LLT Incorrect dose administered because they thought it
had to be incorrect since it was reported
Another coder said the case report should have included more information
about the dose and LLT Incorrect dose administered should not be selected

The selected LLTs should reflect only the information stated in the case report; amedication error should not be inferred if this is not clearly reported as such.
•

In the above example, if an LLT is selected for an incorrect dose but thereport only states that 50 mg of Drug X was administered and does not
mention an incorrect dose, this means that the coder based the coding
selection on information that is not included in the report. Ideally, at the pointof data capture, the reason for reporting as a medication error should be
included in the narrative e.g. ‘the patient was accidentally given 50 mg which
is more than the prescribed dose’.

3.1.10 Device use error vs. device malfunction
What is the difference between device use errors vs. device malfunction?
Sometimes the reports do not have enough information to determine if the incident isrelated to a device issue or a device use error.
Seek clarification whether the report is a device issue or a device use error, since this isa very important distinction. Attempt to code the verbatim information and avoid
inferences.
3.2

Examples for Coding Medication Errors
This sub-section provides examples for coding medication errors in various categories.
The tables are organised in the following way:•

The first column describes a scenario•

The second column indicates whether this scenario is considered a medication
error in the context of the MTS:PTC or not, or if this is unknown from theprovided information•

The third column provides the selected LLT(s) and, if helpful, the relevant PT(s)or HLT(s)•The fourth column provides additional comments and explanations regarding theterm selection

15

The LLTs may fall into more than one category and the concepts presented may overlap
across tables.
3.2.1 Accidental exposures to products
Scenario

Medication
error?

LLT

Comment

A child died after accidental
exposure to a transdermal
patch which had fallen off
another person and got
stuck to the childYes

Accidental exposure
to product by childIn this example, thepoor adhesion is acontributing quality
issue. Death would be
captured as an
outcome.

Person tried to commit
suicide by overdosing onprescription opioids andheroinNo

Person took street heroin to
get high but died of a heroin
overdose

No

Parent accidentally injected
himself in the thumb while
using an auto-injector toadminister the drug to the
child

Yes

Accidental exposure
while administeringdrug

The parent was not theintended patient andwas accidentally
exposed to the drug.
The selected LLT
captures the reported
information withspecificity, e.g., that theaccidental exposure
occurred whileadministering the drug.

Patient with visual
impairment experienced
choking after accidentallyswallowing a desiccant tube
that was the same colour
and similar size as thetablets in the bottle

Yes

Accidental ingestionof product desiccantAccidental exposure iscaptured as well as thecontributing factor oflook-alike productconfusion.
LLT Visual impairment
would be captured in
medical history.

Medicinal patch
adhesion issue
Multiple drug
overdose intentional

This is not a medication
error as the person
intended to overdose

Attempted suicide
Overdose
Opioid abuse

Product appearance
confusion
Choking

It is not known that theoverdose wasintentional; do not codeas accidental overdose
because the scenario isin the context of drug
abuse, not a medication
error. Death would be
captured as an
outcome.

16

Scenario

Medication
error?

LLT

2-year-old child took some
antibiotics that wereaccidentally left on the
kitchen counter

Yes

Accidental drug
intake by child

Adolescent died of overdose
after taking 200 doses of anasal inhalant in under 15
minutes, in an attempt to get
high

No

Drug abuse

Adult ingested 2 tablets of
100 mg strength

Unknown

Adult intentionally ingested 2
tablets of 100 mg strengthfor his back pain instead of
the recommended 1 tablet

No

Overdose

Comment

Overdose in the context
of abuse is not a
medication error nor
Intentional misuse(which implies
therapeutic use
according to the table in
MTS:PTC, Section
3.16). Death would be
captured as an
outcome.
This is not an
informative report andfurther information
should be sought.
There is nothing tocode in the provided
text.

Intentional misuse bydose changeThis is an example ofintentional misuse andis not a medication
error

3.2.2 Miscellaneous medication errors/issues
Scenario

Medication
error?

Pharmacist reported that the
product label was confusing
and that it could result in apatient receiving the wrong
dosage form

Yes

LLT

Comment

Circumstance orThis is an example of ainformation
potential medication error
capable of leading
since the report does not
to medication error state that the wrong productwas actually dispensed oradministered. The LLT
Product label
Circumstanceor information
confusion
capable of leading to
medication error captures
Wrong dosage
that the error is a potential
form
one. The most specific codefor the reported type of
potential medication error
17

Scenario

Medication
error?

LLT

Comment
should be selected and thecontributing factor, label
confusion.

Patient drew her insulin outof the pen with a syringe
because she was confusedby the numbers on theoutside of the dosage
window, and did not want tomistakenly take too muchinsulin using the pen

Yes

Wrong device
usedPatient experienced
hypoglycaemia after he used
his insulin pen cartridge as avial. He reported that he didso because he had leftover
insulin syringes and did notwant to waste them.

No

The pharmacist selected awrong adapter device thatwas incompatible with thedrug; the device started
dissolving when it was used
to transfer the drug from thevial to the bag foradministration

Yes

Patient did not wait therecommended 10 seconds
when using the autoinjector
pen because hemisunderstood how to use
the pen

Yes

Wrong techniquein device usage
process

Pharmacy software had abuilt-in dose calculator thatwas misprogrammed by thepharmacy. The error
resulted in a child getting thewrong dose.

Yes

Dose calculation
error

While hospitalized, patient
experienced an unspecified

Yes

Product design
confusion

Intentional device
misuseHypoglycaemia

Wrong deviceused

The patient uses a wrong
device to prevent an error,
due to her initial confusion
with the pen markings. The
confusion and theconsequent use of thewrong device are both withina scenario of a medication
error, so there is no need to
add Intentional device
misuse.
This is an example ofIntentional misuse: there isa therapeutic purpose but
there is no mention of a
medication error

Capture both that the wrong
device was used and that it
is incompatible with the drug

Drug-device
incompatibility

Do not select LLT Device
use error, since this is abroader term than theselected LLT Wrongtechnique in device usage
processWrong dose
administered
Medication error

This is not an informative
report but is an example
where the verbatim is18

Scenario

Medication
error?

LLT

medication error but noadverse event

Provider administered thewrong dose after using a
faulty mobile medical device(app) that miscalculated thepatient’s insulin needs

Comment
captured with LLT
Medication error.
According to the MTS:PTC,
if a medication error reportspecifically states that there
were no clinicalconsequences, thepreferred option is to select
only a term for the
medication error.
Alternatively, a term for the
medication error and the
additional LLT No adverse
effect can be selected (see
MTS:PTC, Section 3.21).

Yes,
consequent
to a device
issue

Mobile medical
application issue
Dose calculation
error

The issue with the mobile
application is the cause of
the dose calculation error
and the subsequentadministration of the wrong
dose

Wrong dose
administered
Patient split their tablet(labelling doesn’t advise
against splitting the tablet)

No

Prescriber advised patient tosplit the tablet, unaware thatthe labelling states toswallow whole. Patient split
the tablets.

Yes

Patient should be on Drug A
but instead got Drug B; it isunclear where the error
occurredYes

The report does not mention
an error, instead it confirmsthat this is not a medication
error because the label does
not advise not to split. Thereis nothing to code in theprovided text.
Drug prescribing
error
Tablet split bymistakeWrong drug

This is a prescribing errorthat resulted in the patient
splitting the tablet. This is
not a case of off label use,as the prescriber was
unaware that the tablet
should not be split.
This is a “Wrong drug”
medication error; the stage
where the error occurred is
not stated (e.g., atprescribing, dispensing,selection, or administration)
19

Scenario

Medication
error?

LLT

A generic was incorrectly
substituted for the brandname product although thephysician specificallyprescribed the brand nameproduct with no substitution

Yes

Product
substitution error(HLT Medication
errors, product use
errors and issues
NEC)

Patient had thrown
medicated opioid patches in
the open waste bin insteadof disposing as
recommended in the label.
Their child experienced an
overdose after playing withthe patches.

Yes

Incorrect disposalof medication

Comment

Accidental
exposure to
product by child
Accidental
overdose

3.2.3 Product administration errors/issues
Dose omission

As per the MedDRA Concept Description, dose omission is ‘the failure toadminister an ordered dose to a patient before the next scheduled dose, if any.
This excludes patients who refuse to take a medication, a clinical decision (e.g.,contraindication), or other reasons not to administer (e.g., patient sent for test).
For the purposes of retrieval and analysis, in general, a dose omission should beconsidered to be a suspected medication error. There may be scenarios where
doses are missed which are not considered medication errors and therefore aterm such as LLT Therapy interrupted should be used to help to distinguishthese. LLT Therapy interrupted / PT Therapy cessation is included in HLTTherapeutic procedures NEC and is not a medication error concept.
Scenario

Medication
error?

LLT

Comment

Health provider was unable
to mix the contents of thetwo syringes because theplunger was stuck, and thisresulted in leakage where
the two syringes wereconnected. The defectiveplunger resulted in thedose not being given.

Yes

Drug dose omission

This is an example ofa product quality issue
leading to a
medication error

Syringe issue

20

Scenario

Medication
error?

LLT

Comment

Patient was not given thedose of the drug, as thenurse accidentallyadministered the diluent toa patient instead of using
the diluent to reconstitutethe vial containing theactive ingredient

Yes

Drug dose omission

In this scenario, a
preparation error leads
to a medication error

Missed dose

Unknown

Missed dose (PT Drugdose omission)

Patient couldn’t takemedication for a week
because the pharmacy wasout of the medication

No

Temporary interruption oftherapy

Patient had to miss her
antibiotic dose because
there was an insufficientamount of tablets in the
package

Yes

Missed dose

Patient did not takemedication this week
because he could notafford it

NoThis is neither a doseomission in error nor
an intentional doseomission. Use LLT
Temporary interruption of
Temporaryinterruption
therapyof therapy and capturethat external factors
caused theinterruption of therapy.

The afternoon dose washeld because the patient
was scheduled for a
medical procedure

No

Intentional dose omission This is an example ofan intentionallyomitted dose

Patient was busy so hedecided to skip theprescribed evening dose of
insulinNo

Intentional dose omission This is an example ofan intentionallyomitted dose by thepatient

Inappropriate
reconstitution technique(PT Product preparation
error)
Drug administration error

This event is neither
intentional nor a
medication error. Use
LLT Temporary
Product availability issue
interruption of therapy
and capture thatexternal factors
caused theinterruption of therapy.

Product packaging
quantity issue

This event of missing
a dose is due to a
product packaging
quantity issue

Inability to afford
medication

21

Scenario

Medication
error?

LLT

Comment

Patient took the drug asprescribed but broke out ina red itchy rash and did nottake the remaining doses

No

Itchy rash

Stopping therapy
because of an adverse
event does not
represent an error or
intentional misuse

Patient habitually skippedprescribed antipsychotic

No

Therapy cessation by
patient
Treatment
noncompliance

Other administration errors/issues
Scenario

Medication
error?

LLT

Comment

Patient accidentally took 1
tablet twice daily instead of
the prescribed 1 tablet
once daily

Yes

Once daily dose taken
more frequently

When available, it isimportant to select a
specific LLT for thereported scenario, rather
than just the LLT thatmatches the PT
Inappropriate schedule ofdrug administration,
allowing further subanalyses on the LLTlevel.
Although the LLT does
not capture that it was
accidental, it falls under
HLT Productadministration errors andissues.

Tablet crumbled while it
was taken out of the blister
pack, but was stilladministered to the patientYes,
consequent
to a productquality issue

Tablet physical issue“Tablet crumbled” in this
scenario is a productquality issue (LLT Tablet
physical issue); do notselect a medication error
term such as LLT Tablet
crushed incorrectly. The
error is that a productwith a known quality
issue (“crumbled”) was
still administered to thepatient.

Poor quality drug
administered22

Scenario

Medication
error?

LLT

Comment

Syringe plunger couldn’t becompletely pushed down
so the patient received
only half of his scheduled
dose

Yes,
consequent
to a delivery
device issue

Syringe issue

Capture both the device
issue and theconsequent medicationerror

A patient reported that hefollowed the directions foruse, but the pen jammed
and most of the injection
sprayed all over his hands

Yes,
consequent
to a delivery
device issue

Incorrect dose
administered bydeviceDevice delivery
system malfunction
Accidental exposure
while administering
drug
Exposure via skincontact

Patient taking
contraindicated drug

Unknown

Contraindicated drug
administered

The drug was administeredin the abdomen rather than
the arm muscle asrecommended

Unknown

Drug administered atinappropriate site

Patient inquired about
possible overdose
symptoms because she
accidentally took an extra
dose

Yes

Extra dose
administered

Patient reported taking an
expired drug for his
headacheUnknown

Expired drug used

Patient experienced
respiratory arrest after thenurse misprogrammed theinfusion pump to deliver
the drug over 5 minutes
instead of the intended 50
minutesYes

Drug administration
rate too fast

The report states that thepatient is taking acontraindicated drug;
circumstances are notprovided

The patient is only
inquiring about overdose
symptoms (not reportingan overdose).
Although the LLT does
not capture that it was
accidental, it falls under
HLT Productadministration errors andissues.

Inappropriate device
programming23

Scenario

Medication
error?

LLT

Comment

Respiratory arrest

Patient received oral
imaging agent instead ofintended IV imaging agent.
The oral imaging agent
was administeredintravenously through aperipheral line by mistake.

Yes

The patient used a cracked
insulin cartridge which
resulted in a partial dose
administered

Yes

Wrong drug
administered
Enteral formulation
administered by other
route
Incorrect dose
administered bydeviceCartridge cracked

3.2.4 Product confusion errors/issues
Scenario

Medication
error?

LLT

Patient was dispensed
Drug Y instead of Drug X
due to confusion of productpackaging. Drug X andDrug Y had similar looking
packaging.

Yes

Product packaging
confusion

Patient purchased over thecounter (OTC) Drug X 10 ginstead of intended Drug X
5 g because of label
confusion

Yes

Patient accidentally took
the wrong drug for a week
because the tablets looked
identical to his daily vitamin
tablets

Yes

Mix-up of 5 mg/ml with 50
mg/ml product

Yes

Comment

Wrong drug dispensed

Product label
confusion
Wrong drug strength
selected
Look alike pill
appearance
Wrong drug
administered
Wrong strength

It is unclear whether thepatient was administered
the drug. ‘Strength’
pertains to the productitself; ‘dose’ is the24Scenario

Medication
error?

LLT

Comment
amount of drug thepatient receives / should
receive.

Patient was dispensed‘Drillo’ instead of ‘Millo’, as
the pharmacist misheard
the name of the drug as‘Drillo” when the physician
ordered it over the
telephoneYes

Patient experienced skinulceration after applying
the wrong topical cream.
Error attributed to thecreams packaged in thesame size tube with similar
red font and black
background.

Yes

Nurse noted that the
product is labelled toprepare an IV bag for slow
infusion over 10 minutes
only, but it is packaged in aprefilled syringe that could
mistakenly result in direct
IV bolus administration

Yes (potential
error)

Drug name soundalike
Wrong drug dispensed

Product packaging
confusion
Wrong drug
administered
Skin ulceration
Product packaging
confusion

Capture the potential
error and the contributing
factorCircumstance orinformation capable ofleading to device use
error
Incorrect drug
administration rate

3.2.5 Dispensing errors/issues
Scenario

Medication
error?

LLT

Comment

Patient complained thatthe generic didn’t work as
well as the innovator drug

No

Product substitution
issue brand to genericThis is a product quality
complaint

Drug effect decreased
A generic was substituted
for the brand nameproduct

Unknown

Product substitution(HLT Therapeutic
procedures NEC)

Code only what is stated.
The report does not
specify an error.

25

Scenario

Medication
error?

LLT

Patient received expired
patches from thepharmacy

Yes

Expired drug
dispensed

Patient took the drug daily
instead of on the intended
weekly schedule because
the clinic wrote the wrong
directions on the vial

Yes

Wrong directions typed
on label (PT Drugdispensing error)

Drug was not dispensed in
the original container,
although the labelling
advises that the drug must
be kept in the originalcontainer

Yes

Drug not dispensed inoriginal container

The prescription wasillegible and resulted in thepharmacy dispensing thewrong strength

Yes

Wrong drug strength
dispensed

Pharmacy dispensed drugwith the pharmacy label
obscuring therecommended storage
information. Product stored
at wrong temperature.

Yes

Comment

Once weekly dosetaken more frequently

LLT Transcription
medication error covers
the concept of legibility

Transcription
medication error
Drug dispensing error
Pharmacy label placed
incorrectly
Product storage error

3.2.6 Monitoring errors/issues
Scenario

Medication
error?

LLT

Patient was hospitalizedwith thromboembolism
because his INR wasn’t
monitored asrecommended in thelabelling

Yes

Drug monitoringprocedure not
performed

Patient experienced
rhabdomyolysis after
taking two drugs that arelabelled for a drug-druginteraction

Yes

Comment

Thromboembolism
Labelled drug-druginteraction medication
error

26

Scenario

Medication
error?

LLT

Comment

Rhabdomyolysis
Literature report
hypothesised a possible
drug interaction caused thepatient to experiencehypotension

No

Patient experienced type I
hypersensitivity after
receiving amoxicillin during
surgery. The patient’s ehealth record had adocumented history ofamoxicillin allergy. The
error was attributed to thelack of interoperability
between the anaesthesia
software and the hospital’s
e-health record.

Yes

Patient on anticoagulant
undergoing surgery but it
was not stopped prior tosurgery as recommended
in the labelling and patient
experienced postoperative
bleeding

Yes

Provider prescribed two
drugs with known druginteraction because he wasunaware of the interaction
potential

Yes

Drug interaction
Hypotension
Hypersensitivity type I
Documented
hypersensitivity toadministered drug
Device computer
software issue

Medication monitoring
error
Failure to suspend
medication
Postoperative bleeding
Labelled drug-druginteraction medication
error
Drug prescribing error

27

3.2.7 Preparation errors/issues
Scenario

Medication
error?

LLT

Comment

Caregiver wasn’t aware to
remove the inner coverfrom an insulin pen needle
when preparing the pen

Yes

Product assembly
error during
preparation for use

Selected term, LLT Productassembly error during
preparation for use, is more
specific to the reported
information than LLT
Device use error

Product was reconstituted
with the wrong diluent

Yes

Wrong solution used in
drug reconstitution

Pharmacy compounded
the wrong strength
product

Yes

Product compounding
error
Wrong strength

Patient received only one
component of a twocomponent productbecause the nurse wasn’t
aware that the twocomponents needed to bemixed together before
administration

Yes

Product preparation
error

Pharmacy prepared
incorrect concentration
because of confusion
related to the way thestrengths for the two
active ingredients werestated on the label

Yes

The technician didn’t
follow the instructions to
mix the contents of thevial for 5 minutes afterreconstitution

Yes

Product preparation
error

Respiratory therapist put
the canister in an inhaler
the wrong way

Yes

Product assembly
error during
preparation for use

Single component of a
two-component
product administered
Wrong concentration
prepared
Product label
confusion
LLT Product preparation
error (HLT Productpreparation errors andissues) is more specificthan LLT Wrong techniquein product usage process(HLT Medication errors,
product use errors andissues NEC)28

3.2.8 Prescribing errors/issues

Scenario

Medication
error?

LLT

Comment

Drug prescribed in error for
unauthorised use

Yes

Drug prescribing error

This is a prescribing error.
Off label use should not be
coded in addition. Off label
use is an intentional act not
an error.

Prescribed Drug X insteadof Drug Y because thenames sounded alike

Yes

Drug prescribing error It is important to be able toidentify the confusion as aroot cause
Drug name soundalike

Prescribed 4 mg/kg insteadof 0.4 mg/kg. Prescriber
realised immediately andcalled nurse but nurse hadalready administered the
drug.

Yes

Drug dose prescribing Even though the error was
error
detected it was notintercepted in time

Patient was switched todifferent insulin product but
dose adjustment was not
written on the prescription.
Patient administered thewrong dose andexperienced
hypoglycaemia.

Yes

Patient was prescribed 2times the appropriate dose
due to computerisedprescriber order entry(CPOE) error

Yes

Patient with intractableseizures and taking
multiple drugs wasprescribed acontraindicated drug

Unknown

Contraindicated drug
LLT Seizures should beprescribed
captured as medical history

Patient was prescribed 0.5
mg to be taken by splitting
the 1 mg tablet

Unknown

No event to code based on
the stated information. It is
not known if this is aprescribing error, off label
use, or neither. If this is the
ONLY information, this isWrong dose
administered
Drug dose prescribing
error
Wrong dose
administered
Hypoglycaemia
Drug dose prescribing
error
CPOE error

29

Scenario

Medication
error?

LLT

Comment
not a case and should not
be recorded.

Patient prescribed 1 tablet
daily for insomnia for many
years. The productdirections state that the
product should not betaken for more than 2
weeks.

Unknown

Inappropriateprescribing

Patient hospitalised forwithdrawal symptoms after
his unspecified opioids
were inappropiately
downtitrated

Unknown

Opiate withdrawal
symptoms

Patient prescribed 0.25 mg(off-label starting dose)No

Off label dosing

Physician ordered thewrong rate ofadministration for the IVdrug, and the patient
experienced hypotension

Yes

Incorrect drug
administration rate

Inappropriate drug
titration

Hypotension
Drug prescribing error

When patient became
pregnant, neurologist
switched her to an
extended release producttwice daily (off label)instead of recommended
once daily administration

No

Patient accidentallyreceived duplicate therapy
because the prescriber
didn’t realise the 2 drugs
had the same active
ingredientYes

Off label use
Drug use forunapproved dosing
regimenDuplicate drugprescription error
Duplicate therapy
error

30

3.2.9 Product selection errors/issues
Scenario

Medication
error?

LLT

Comment

The patient confirmed that
due to the cataract, thepatient did not see well andended up buying the infant
formulation

Yes

Product selection
errorThis is not a product nameconfusion.
Cataract would be captured
as medical history.

Pharmacist selected thewrong drug because ofname confusion, but theerror was caught andcorrected before the drug
was dispensed

Yes

Intercepted wrong
drug selected

It is important to capture thecause of the error

The hospital selected thewrong bag and the patient
received a transfusion of
the wrong blood type prior
to and during surgery

Yes

Clerk ordered the wrong
drug from the wholesaler
because the drugs werelisted next to each other inthe catalogue and thenames looked very similar

Yes

Drug name confusion

Wrong productselectedTransfusion withincompatible blood
Wrong drug selected
Drug name look-alike

3.2.10 Product storage errors/issues
Scenario

Medication
error?

LLT

Comment

Healthcare facility reported
storing reconstituted drugin syringes past therecommended 30 days,
and administering it topatients. One of thesesyringes was used by apatient who reported thatthe drug didn’t work.

Yes

Improper storage ofunused product

LLT Poor quality drug
administered should not be
selected because theselected LLT Expired drug
administered is more specificVaccine product wasstored in the pharmacy at
excessive temperatures

Yes

Expired drug
administered
Lack of drug effectProduct storage error This is a medication error, as
temperature too highthe error occurred in the
product use system
31

Scenario

Medication
error?

LLT

The pharmacy staff
member could not finddrug as it had
inadvertently been placedon the wrong shelf

Yes

Drug stored in wrong
location

Boxes of the drug sentfrom the manufacturer
were left outside atexcessive temperatures
over the weekend when
the wholesaler was closed

No

Manufacturing
This storage problem is not a
product storage
medication error because it
issue (HLT Productoccurred under
manufacturing distribution
distribution andstorage issues, SOC and storage activities, priorProduct issues).
to the product reaching the
medication use system

Pharmacy delivered thedrug to arrive while thepatient was hospitalised.
The package was outsideat temperatures below
freezing for two days (drugshould not be frozen).

Yes

Product storage error This is a medication error, as
temperature too low
the error occurred in the
product use system

Manufacturer issued arecall of certain lots ofDrug X that were found to
be exposed toinappropriate storage
conditions by thewholesaler

No

Pharmacy mistakenly
stocked the wrong drug inthe automated dispensing
system. Reporter
attributed the error to bothdrugs being packaged insimilar sized vials withlook-alike container labels.

Yes

Manufacturing
product storage
issue
Recalled productComment

This storage problem is not a
medication error because it
occurred under
manufacturing distribution
and storage activities, prior
to the product reaching the
medication use system

Drug label look-alike
Wrong drug stocked
Product packaging
confusion32

3.2.11 Product transcribing errors/communication issues
Scenario

Medication
error?

LLT

Healthcare provider
called in a prescription for
Drug A, but pharmacy
wrote down theprescription as Drug B

YesTranscription
medication error

Pharmacy dispensed 800
mg strength instead of
600 mg due to data entry
error

Yes

Product data entryerror

Physician ordered insulin
pens, but a transcription
error transpired with thepharmacy and the patient
was dispensed insulin ina vial with syringes
insteadYes

Patient had an issuecommunicating and wasgiven the possible
diagnosis of autism

No

Comment

Wrong drug strength
dispensed
Transcription
medication error
Wrong device
dispensed
Communication
disorderAutismDespite the terms “issue” and“communicating” in theexample, this is not a
medication error and should
not be captured under LLT
Product communication
issue, but rather should be
captured under LLTCommunication disorder33