MedDRA®
POINTS TO CONSIDERCOMPANION DOCUMENT
ICH-Endorsed Guide for MedDRA Users
Release 1.1
July 2020
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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................................................................ 9

3.1 Coding Medication Errors – Questions and Answers ............................... 10
3.1.1 Use of LLT Medication error ........................................................... 10
3.1.2 Selecting more than one term ......................................................... 11
3.1.3 Medication error vs. off label use .................................................... 11
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 ........................ 12
3.1.7 Stages of the medication use system ............................................. 13
3.1.8 Coding the root cause ..................................................................... 14
3.1.9 Do not infer a medication error ....................................................... 14
3.1.10 Device use errors, wrong technique, and 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............................................... 21
3.2.4 Product confusion errors/issues...................................................... 25
3.2.5 Dispensing errors/issues................................................................. 26
3.2.6 Monitoring errors/issues.................................................................. 28
3.2.7 Preparation errors/issues ................................................................ 29
3.2.8 Prescribing errors/issues ................................................................ 30
3.2.9 Product selection errors/issues ....................................................... 32
3.2.10 Product storage errors/issues ......................................................... 33
3.2.11 Product transcribing errors/communication issues ......................... 34i

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 are certain topics where users could benefit from having moredetailed information pertaining to the use of MedDRA than can be covered in theexisting documents.
The purpose of this Companion Document is to supplement the Points toConsider (PtC) documents by providing additional details, examples, andguidance on specific MedDRA-related topics of global regulatory importance. It
was developed and is maintained by the same working group that was charged
by the ICH Management Committee to develop the PtC documents. The working
group consists of representatives of ICH regulatory and industry members, theWorld Health Organization, the MedDRA Maintenance and Support Services
Organization (MSSO), and the Japanese Maintenance Organization (JMO).
The Companion Document is intended to be a “living” document and is updated
based on users’ needs, rather than being tied to MedDRA releases. 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, thesewill 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 and this Companion Document.
Users are invited to contact the MSSO Help Desk with any questions orcomments 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 the use of MedDRA in the clinical trial and postmarketing environments. It will
not address specific regulatory requirements, database structure issues, fileformat conventions, data workflow applications, or other topics which are beyond
the scope of MedDRA.
In both the development and marketing of human medicinal products, datacollection is a critical and ongoing process. As noted in the MedDRA Term
Selection: Points to Consider (MTS:PTC) document, the quality of originalreported 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 ofbiopharmaceutical products. Since data are used for activities ranging fromcoding to information categorisation, retrieval, analysis, and presentation,
ensuring access to high quality data is paramount. Quality data support safetyfunctions 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 ofsafety reporting regulations and standards, there is an increasing emphasis on
safety surveillance 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 andmarketing authorisation holders). Collection of high quality data can also result ingreater time and cost efficiency during product development and marketing (e.g.
less querying of incomplete data, decrease site monitoring costs and reduce therisk of delayed regulatory approval).
The quality of adverse event data is central to safety monitoring in clinical trials,
to the risk assessment of marketing applications and in the evaluation of safety
signals within postmarketing data. Adverse events are typically generated bycomplaints 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 awarethat some LLTs are rather non-specifc and that further clarification of thereported information may be necessary. Small deviations in coding can result insignificant issues and produce misleading analyses. Coding selections may varyeven in apparently simple cases.Given this variability, it is important tothoughtfully 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
both complete and accurate. Whenever possible, the most concise form of data
should be collected, provided that this can be done without sacrificing either
completeness or accuracy. Within an organisation, data quality is fostered bycomprehensive, consistent, transparent and documented data handlingprocesses. Quality data is, by definition, supported by the available information.
For example, clinical diagnoses should be consistent with the available medical
history, physical findings, laboratory and investigational results. Furthermore,quality data should be capable, when appropriate, of supporting data-related
associations (e.g. when performing a causality assessment of an 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 clinicaldevelopment and postmarketing surveillance, MedDRA should play an importantrole in a sound data quality strategy. Since MedDRA is used to “code”
information during data entry, it is important to consider the principles in the
MTS:PTC document to ensure the selection of coding terms with the highest
specificity and analytical quality. The large number of available LLTs provides ahigh 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
a complex 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 discussa 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 those collecting information (e.g. a study site physician/nurse, apostmarketing call center employee, a dispensing pharmacist, an emergency
room physician), certain practices will help to maximise the quality of thecollected data:• During data collection, completeness and accuracy need to be weighedagainst the risk of collecting “unimportant” information. This is particularly
true if time limitations are present. It is advisable to minimise the amountof unimportant information placed in dedicated data fields for key concepts
such as adverse events. Otherwise, the data coding and management canbe further complicated.
•

In clinical trials, reporters should be encouraged to use consistent medical
terminology to describe similar medical concepts. The best strategy is to3carefully train study site personnel (especially investigators) about theimportance of consistency in data collection.
•

In clinical trials, data collection instruments (whether they are electronic or
paper case report forms) should be carefully designed to be easy to use,
enduring and sufficiently comprehensive to gather all the necessary
information. Since individual trials or clinical projects can span years, it isnever possible to spend “too much” time developing quality data collection
tools. Appropriate “subject matter experts” in data management,
information technology, statistics, quality assurance, and regulatorycompliance should be involved throughout the planning process. After
years into development, it is difficult, if not impossible, to compensate forneeded 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 ofimportant 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 isusually appropriate to record these as separate concepts on the datacollection form•

Attempt to minimise spelling errors and the use of abbreviations andacronyms. The table below illustrates the difficulty of interpreting suchpoor or ambiguous data:•

Reported

Data Quality Challenge

Had MI

Does MI stand for myocardial
infarction, mitral insufficiency, mental
illness or mesenteric 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.
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, and product quality issues. For meaningful data review, it isimportant to ensure that all required information is coded consistently. Importantdata 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 requisitetraining to utilise it effectively. Particular attention should be paid to therelevant coding principles outlined in the MTS:PTC document. In
environments where MedDRA coding is performed by a number ofindividuals, it is important to have a consistent organisational approach.
•Appropriately trained individuals should review MedDRA coding•

It is an important concept that all adverse events and adverse reactions
from a report should be coded, regardless of causal association. Similarly,
do not add information by selecting a term for a diagnosis if only signs or
symptoms are reported (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 lesssevere than the reported term (e.g., coding a convulsive seizure with LLTShakiness 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 provisionaland definitive diagnoses with associated signs and symptoms. If one
chooses to use an “alternate” coding option from the MTS:PTC, it is agood practice to document why this was done and to be consistent in theuse of this alternate choice.

•

It is important to distinguish medical conditions (typically found in the SOCof the primary manifestation site) from laboratory and test terms (which
are found in SOC Investigations)5•

Verbatim terms may contain more than one medical concept (such as areport of “fall and contusion”). It is important to consider each of thereported events and code as appropriate.

•

Consider the use of “split coding” (selecting more than one term) where
there is no 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
can then be coded to pre-determined LLTs. An example of a synonym listis shown below:
Reported Verbatim
LLT
Throbbing above temple
Aching all over head
Pulsing pain in head

In a synonym list, each of these verbatim
reports would be coded using LLTHeadacheSynonym lists may be particularly helpful in some circumstances, e.g. whenthose involved in report coding have limited medical expertise, when coding is inseveral 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 the procedure (MTS:PTC Section 3.13.1). On the other hand, if aprocedure is reported with a diagnosis, then the preferred option is toselect 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 have data collection forms with separate data
fields for adverse events and for procedures; this aids entry of data in theappropriate category.
•In the context of safety reporting, death, disability and hospitalisation areoutcomes, not adverse events. Therefore, they are generally not codedwith MedDRA. Instead, they are recorded in the appropriate datacollection field for outcomes. One exception to this recommendation iswhen death, disability, or hospitalisation is the only reported verbatim.
These concepts are coded with MedDRA while clarification of theunderlying cause is sought (see MTS:PTC Section 3.2 for further
information). In addition, death terms that add important clinicalinformation (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:
6

Vague information (see also MTS:PTC Section 3.4.3):
Reported
LLT Selected
Appeared red

Unevaluable event

Comment“Appeared red” reported
alone is vague; this
could refer to a patient’s
appearance or eventhat of a product (i.e., apill, a solution, etc.)

Ambiguous Information (see also MTS:PTC Section 3.4.2):
Reported
LLT Selected
Comment
Patient had medical
history of AR

Ill-defined disorder

It is not known what
medical condition thepatient had (aortic
regurgitation, arterial
restenosis, allergic
rhinitis?), so LLT Illdefined disorder can beselected

Conflicting Information (See also MTS:PTC Section 3.4.1):
Reported
LLT Selected
Comment
Severe anaemia with ahaemoglobin of 19.1
g/dL

Haemoglobin abnormal

LLT Haemoglobin
abnormal covers both of
the reported concepts(note: haemoglobinvalue of 19.1 g/dL is ahigh result, not a low
result as would be
expected in severe
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 and procedures should be documented in writing and continuallyreviewed for updates. Training should be performed by appropriately qualified
individuals who are knowledgeable about the organisation’s standardised
procedures and focused on compliance. Cross-training of key functions isadvisable to ensure a consistent approach and to preserve data quality
standards during periods of unexpected personnel changes.
Given that organisations may commonly use unfamiliar or remote study sites forclinical trial conduct, it is also important to ensure that study site personnel (e.g.,
investigators, study nurses, clinical study coordinators, clinical research7

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 ofadverse events as diagnoses (when possible) rather than lists of signs
and symptoms, precautions to avoid unblinding]•Knowledge of relevant regulatory considerations related to quality datacollection•

Adequate knowledge of the use of MedDRA for coding purposes, asapplicable. This is particularly important for concepts such as coding of
definitive versus provisional diagnoses (with or without symptoms) and notinferring 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/training-materials) is another useful resource. This
customisable slide set is intended for use at investigator meetings and fortraining personnel involved with data collection (such as clinical research
associates and clinical coordinators). It provides an overview of the importanceand 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:
ReportedAllergic to CAT scan

Feels pressure in eye

Inaccurately
Selected LLTAllergic to cats

Intraocularpressure

QA Review Outcome
This inaccurate LLT was selectedby an autoencoder which matched
the words “Allergic to CAT scan”
from the reported termThis inaccurate LLT refers to thename of the test for intraocularpressure; the appropriate term toreflect the symptom being
described in the report would be
LLT Sensation of pressure in eye

8These checks can identify coding errors with MedDRA before the database islocked and erroneous data become part of a data analysis.
The MSSO-maintained Unqualified Test Name Term List is a comprehensive
collection of all unqualified test name terms at the Preferred Term (PT) andLowest Level Term (LLT) levels in SOC Investigations. The Unqualified Test
Name Term List can be found on the “Support Documentation” page on the
MedDRA website. It may be applied by regulatory authorities and industry as a
QA check of data quality in clinical trial and pharmacovigilance 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 specificdatabase field. For example, in the section for Results of Tests and Proceduresin 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 arecommendation only, providing a standard tool for checking coding quality.
2.4.5 MedDRA versioning strategy
Given the twice-yearly releases of new MedDRA versions, organisations shouldhave a documented versioning strategy to address these updates. The MSSO
has created a Best Practice document which contains sections entitled“Recommendations for MedDRA Implementation and Versioning for Clinical
Trials” and “Recommendations for Single Case Reporting Using Semi-annual
Version Control”. This document is found on the “Support Documentation” pageon the MedDRA website.
In addition, the MSSO has provided a MedDRA Version Analysis Tool (MVAT)
which facilitates 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).
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 toprovide guidance on scenarios that are medication errors as well as scenarios
informative for medication errors or scenarios that are confused with 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 23.0.
The document is a living document and the content of this section will be updated
based on user feedback. Users are invited to contact the MSSO Help Desk withany questions or comments about the MedDRA Points to Consider Companion
Document.

9

Acknowledgments
The PtC Working Group would like to acknowledge the significant contributionsof the following 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 HighLevel Group Term (HLGT) Medication errors and other product use errors andissues (from MedDRA Version 20.0 onwards). However, terms located elsewherein the MedDRA hierarchy can also be used to code cases describing medication
errors. To aid data retrieval of the widely dispersed coding terms, theStandardised MedDRA Query (SMQ) Medication errors was developed, with anarrow and a broad scope, as a tool for standardised retrieval of suspected
medication error cases.
The HLGT Medication errors and other product use errors and issues contains
numerous terms:• Types of errors (e.g., LLT Wrong drug),• Terms combining the type of error with a stage of the medication use
system (e.g., LLT Wrong drug prescribed)• Describing the potential for error• Intercepted errors that did not reach the patient• This HLGT also contains terms for situations when it is uncertain 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 HLT grouping for various other PTs not elsewhere classified.
*For the purposes of this document, the medication use system encompasses acontinuum of activities after release of the product into the healthcare system
during which a medication error can occur, including procurement, storage,prescribing, transcribing, selecting, preparing, dispensing, administering, andmonitoring. The medication use system excludes activities related to the 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 theerror?
• The use of LLT Medication error should be avoided unless there is
NO other information reported about the medication error

10•Check all the LLTs in HLGT Medication errors and other productuse 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 theChange Requests page on the MedDRA website). In the interim,
select the closest available term to code the reported error. Theremay 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 thewrong drug consequently resulted in the wrong drug being dispensed andadministered.”•The ‘originating’ error should be coded as the priority. Additional or‘consequent’ errors can be coded if they are stated in the report. In
the above example, the priority is to code LLT Wrong drugprescribed; LLT Wrong drug dispensed and LLT Wrong drug
administered are terms for consequent 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 ageneral and a specific verbatim; code only the specific error. For
example, if it is reported that there was an administration error inthat the wrong drug was administered, select only LLT Wrong drug
administered for the specific error. Do not use an additional LLT
Drug administration error for the general description because thiswould not add any meaningful information (even though the two
LLTs are linked to different PTs).

•

Bear in mind that some organisations will have their databaseconfigured 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 forboth possibilities be selected, as in differential diagnoses?
• Do not double code a singular event by selecting a term for an error
and a term for off label use when neither is stated but both arepossible; this approach is not helpful.

11•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 was prescribed at a much higher dose thanper label (no information that it was in error or off label use), selectLLT Prescribed overdose (HLT Overdoses NEC).

•

Off-label use terms should only be selected when off label use isspecifically mentioned in the reported verbatim information.

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 insomeone 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:
o For the potential error (LLT Circumstance or information
capable of leading to medication error)o For the contributing scenario (LLT Drug label look-alike)o 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 to reconstitute before self-administering.
• 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 Wrong technique in product usage process). Coding a
singular error by selecting two error terms is useful only when thisprovides meaningful additional information, i.e. when the single LLTcannot 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 taken from the National
Coordinating Council for Medication Error Reporting and Prevention (US)* and is
as follows:12Medication errors are defined as any preventable event that may cause or lead toinappropriate medication use or patient harm while the medication is in thecontrol of the health care professional, patient or consumer. Such events may berelated to professional practice, health care products, procedures and systems,
including prescribing, order communication, product labeling, packaging andnomenclature, 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 1 March, 2020.

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:•••

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
misuseOccurrence of an adverse drug reaction (ADR) may cause thepatient to stop therapy; this is not intentional misuse or an error.
Therapy cessation due to an ADR is usually captured elsewhere in
the database, and only the ADR is coded in the case.
Patient 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
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 ofthe 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 oferror (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
this example, this is possible using a single LLT Wrong drug dispensed (insteadof two LLTs: LLT Wrong drug and LLT Wrong drug dispensed).
• Using more than one LLT
13

For example, a report of ‘mistakenly prescribed the wrong strength’ should be
coded with LLT Wrong strength and LLT Drug prescribing error because noavailable 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 LLTWrong drug, 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 andidentifying interventions that can be undertaken to prevent the error.
•

For example, a product quality issue may lead to a medication error; insuch a case, the product quality issue is the root cause of the error.
Select terms for both the quality issue and the error.

•

For example, a communication issue may lead to a medication error; insuch a case, the communication issue is the root cause of the error.
Select terms for both the communication issue (e.g., LLT Patient
misunderstanding health care provider instructions for product use)
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 include issues such as human factors(stress, fatigue) or system issues (training deficiencies, unclear
instructions).

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?
The selected LLTs should reflect only the information stated in the case report; itshould not be assumed that a medication error occurred if this is not clearlyreported as such.
For example, the report that only stated ‘The nurse administered 50 mg of Drug
X’ is not an informative report and should not be submitted as such; further
information should be sought or a dose qualification referencing the prescribing
information should be provided in the narrative.
Ideally, at the point of 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’. Alternatively, if it is not possible toclarify with the reporter but the prescribing information recommends a smallerdose, then the report should reference the prescribing information in the
narrative, e.g. “the nurse administered 50 mg of Drug X, whereas therecommended dose in the prescribing information is 5 mg.”14

3.1.10 Device use errors, wrong technique, and device malfunction.
What is the difference between a device use error, wrong technique, anddevice malfunction?
When evaluating medication errors involving devices, it is important to capture
the specific device related event that led to the error. Such events can beproblems with the device itself (including device malfunctions), or they can beproblem with the way the device is used by the person (device use error or wrong
technique). In MedDRA, device use errors refer to broad errors in using thedevice appropriately, e.g., LLT Unintentional device use beyond labelled
duration. In contrast, the wrong technique in device usage process concepts
refer specifically to the technical aspect of not properly using the device (e.g.,
LLT Incorrect needle gauge used, LLT Wrong injection technique). Device
malfunction refers to failure of the device to perform as intended when used inaccordance with the labelling. A malfunction of a device is not considered adevice use error or a wrong technique error.
Sometimes the reports do not have enough information to determine if theincident is related to a device issue/malfunction, device use error, or wrong
technique. Clarification should be sought since these are very importantdistinctions. 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 the provided information•

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

The LLTs may fall into more than one category and the concepts presented may
overlap across tables.

15

3.2.1 Accidental exposures to products
Scenario
Medication
LLT
error?
Person tried to commit
No
Multiple drug
suicide by overdosing on
overdoseprescription opioids andintentionalheroinAttempted suicide
Person took street heroin
No
Overdoseto get high but died of aheroin overdose
Opioid abuse

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

It is not known thatthe overdose wasintentional; do notcode as accidental
overdose because
the scenario is in thecontext of drug
abuse, not a
medication error.
Death would be
captured as an
outcome.
Accidental
The parent was not
exposure while
the intended patient
administering drug and was accidentally
exposed to the drug.
The selected LLT
captures the reported
information withspecificity, e.g., thatthe accidental
exposure occurred
while administering
the drug.
Accidental ingestion Accidental exposureof productis captured as well as
desiccantthe contributing factorof look-alike productconfusion.
Product
LLT Visualappearance
impairment would be
confusion
captured in medical
history.
Choking

Parent accidentally
injected himself in the
thumb while using an
auto-injector to administer
the drug to the childYes

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

Yes

2-year-old child took some
antibiotics that wereaccidentally left on the
kitchen counter
Adolescent died ofoverdose after taking 200

Yes

Accidental drug
intake by child

No

Drug abuse

Overdose in thecontext of abuse is16

Scenario

Medication
error?

doses of a nasal inhalantin under 15 minutes, in an
attempt to get high

LLT

Comment

Overdose

Adult ingested 2 tablets of
100 mg strength

Unknown

Adult intentionallyingested 2 tablets of 100
mg strength for his backpain instead of therecommended 1 tablet

No

not a medication error
norIntentional misuse(which implies
therapeutic use
according to the tablein 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 This is an example ofby dose change
intentional misuse
and is not a
medication error

3.2.2 Miscellaneous medication errors/issues
Scenario
Medication
LLT
Comment
error?
Pharmacist reported that
Yes
Circumstance or This is an example of athe product label was
information
potential medication error
confusing and that it could
capable ofsince the report does not
result in a patientleading tostate that the wrong
receiving the wrong
medication error
product was actuallydosage form
dispensed oradministered. The LLT
Product label
Circumstance or
confusion
information capable ofleading to medication
Wrong dosage
error captures that theformerror is a potential one.
The most specific codefor the reported type of
potential medication error
should be selected andthe contributing factor,
label confusion.
17

Scenario
Patient drew her insulin
out of the pen with asyringe because she was
confused by the numbers
marked on the pen, anddid not want to mistakenly
take too much insulin
using the pen

Patient experienced
hypoglycaemia after heused his insulin pen
cartridge as a vial. He
reported that he did so
because he had leftover
insulin syringes and did
not want to waste them.
The pharmacist selected awrong adapter device thatwas incompatible with thedrug; the device started
dissolving when it wasused to transfer the drug
from the vial to the bag foradministration
Patient did not wait therecommended 10
seconds when using the
autoinjector pen because
he misunderstood how to
use the pen

The patient forgot to have
her hormonal IUD
replaced after therecommended 5 years. In
the 7th year after device
was originally inserted,
she became pregnant.

Medication
error?
Yes

No

Yes

LLT
Wrong deviceused

The patient uses a wrong
device to prevent anerror, due to her initialconfusion with the pen
Product design
markings. The confusion
confusionand the consequent useof the wrong device areboth within a scenario of a
medication error, so there
is no need to add
Intentional device misuse.
Intentional
This is an example ofdevice misuse
Intentional misuse: there
is a therapeutic purposebutthere is no mention of
Hypoglycaemia
a medication error

Wrong device
usedDrug-device
incompatibility

Yes

Yes

Comment

Capture both that thewrong device was used
and that it is incompatible
with the drugWrong technique Do not select LLT Device
in device usage use error, since this is aprocess
broader term than theselected LLT Wrongtechnique in device usage
process. The selected
LLT represents atechnical error with using
the device.
Unintentional
LLT Unintentional device
device use
use beyond labelled
beyond labelled duration (PT Device use
duration
error) represents a broad
error in using the device
appropriately
according to
Pregnancy withrecommendations for its
IUD
intended use.

18

Scenario
Pharmacy software had abuilt-in dose calculator
that was misprogrammedby the pharmacy. The
error resulted in a childgetting the wrong dose.

Medication
error?
Yes

LLT

Comment

Deviceprogramming
error
Dose calculation
error associatedwith device

While hospitalized, patient
experienced anunspecified medication
error but no adverse event

Yes

Nurse administered thewrong dose after using a
faulty mobile medical
device (app) thatmiscalculated the patient’s
insulin needs

Yes,
consequent
to a device
issue

Wrong dose
administered
Medication error

This is not an informative
report but is an example
where the verbatim iscaptured with LLT
Medication error.
According to the
MTS:PTC, if a medication
error report specificallystates that there were noclinical consequences,the preferred option is toselect only a term for the
medication error.
Alternatively, a term forthe medication error andthe additional LLT No
adverse effect can beselected (see MTS:PTC,
Section 3.21).
Mobile medical The issue with the mobile
application issue application is the cause of
the dose calculation error
and the subsequent
Dose calculation
administrationof theerror associatedwrong dosewith device
Wrong dose
administered

Patient split their tablet(labelling doesn’t advise
against splitting the tablet)No

The report does not
mention an error, instead
it confirms that this is nota medication error
because the label does
not advise not to split.
19

Scenario

Medication
error?

LLT

Comment
There is nothing to codein the provided text.

Provider prescribed half atablet once daily, unawarethat the labelling states toswallow the tablets whole.
Patient split the tablets.

Yes

Prescriber advised patientto split tablet. The
labelling states thattablets should beswallowed whole.

Unknown

Patient should be on Drug
A but instead got Drug B;
it is unclear where theerror occurredYes

A generic was incorrectly
substituted for the brandname product although
the physician specificallyprescribed the brandname product with nosubstitution
Patient had thrown
medicated opioid patches
in the open waste bin
instead of disposing as
recommended in thelabel. Their childexperienced an overdose
after playing with thepatches.

Yes

Yes

Product
This is a prescribing error
prescribing error that resulted in the patient
splitting the tablet. This is
not a case of off label
Tablet split byuse,
as the prescriber
mistake
was unaware that thetablet should not be split.
Product
Select LLT Productprescribing issue prescribing issue since it
is not known whether thisis unintentional (amedication error) or
intentional (off label use).
The report does notindicate whether theprescriber was aware thatthe tablets should beswallowed whole.
Wrong drug
This is a “Wrong drug”
medication error; thestage where the error
occurred is not stated(e.g., at prescribing,dispensing, selection, or
administration)
Product
substitution error(HLT Medication
errors, productuse errors andissues NEC)
Incorrect
disposal of
medication
Accidental
exposure to
product by child

The route of exposure isnot specified in theverbatim information andtherefore cannot be
coded

Accidental
overdose203.2.3 Product administration errors/issues
3.2.3.1 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. However, there are scenarios
where doses are missed which are not considered medication errors. The cause
or contributing factors for the dose omission are necessary to determine if theomission is a medication error or not, and consequently to select the appropriate
MedDRA terms. Scenarios where dose omission occurs can be generallygrouped as follows:o Dose omission unintentional (error) (e.g., patient misunderstood
instructions; pen device jammed and patient could not deliver thedose; patient forgot to take dose)o Dose omission intentional (e.g., patient skips a dose of anantidiabetic because of low blood sugar, medicine held one dayprior to surgery)o Dose omission that is unspecified (cause / contributing factors
unknown)o Therapy interruption (neither an error nor intentional. Due to nonclinical or external factors such as supply, insurance, financial
issues, etc.)

Scenario
Health provider reported
a problem that resulted
in leakage where the twosyringes wereconnected. This led tothe dose not being given.

Patient was not given thedose of the drug, as thenurse accidentallyadministered the diluent
to the patient instead ofusing the diluent toreconstitute the vial
containing the active
ingredient

Medication
error?
Yes

LLT

Comment

Syringe connection
issueThis is an example
of a device issue
leading to a
medication error.

Device leakage

Yes

Drug dose omission by
deviceMissed dose in error
Active ingredient notadded to diluent(PT Productpreparation error)

In this scenario,
dose omission is anerror caused by
failure to reconstitutethe vial with thediluent. The specificterm LLT Missed
dose in error should
be selected if thereport indicates that21

Scenario

Medication
error?

LLT

Comment

Single component of a the dose omission is
two-component
an error.
product administered
Missed dose

Unknown

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

No

Patient missed her dose
because she did not
notice that one of thedosage units in the
package was empty

Yes

Patient did not takemedication this week
because he could notafford it

No

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

No

Patient’s blood sugar
was low so he decided toskip the prescribedevening dose of insulin

No

Missed dose (PTProduct doseomission)
Temporary interruption This event is neitherof therapy
intentional nor a
medication error.
Use LLT Temporary
Product availability
interruption of
issue
therapy and capturethat external factors
caused theinterruption oftherapy.
Missed dose in error
This event of
missing a dose isdue to a productPackage empty units
packagingquantity(PT Product packaging
issue
quantity issue)
Inability to afford
This is neither a
medicationdose omission inerror nor an
intentional dose
Temporary interruption
omission.
Use LLTof therapy
Temporaryinterruption oftherapy and capturethat external factors
caused theinterruption oftherapy.
Intentional doseThis is an example
omissionof an intentionallyomitted dose
Intentional doseomission

This is an example
of an intentionallyomitted dose by thepatient

22

Scenario
Patient took the drug asprescribed but broke out
in a red itchy rash anddid not take theremaining doses

Patient habituallyskipped prescribed
antipsychotic
The on-body infuser fell
off the patient’s arm andshe missed the dose

Patient forgot to take his
medication on one day
during the week

Medication
error?
No

LLT

Comment

Itchy rash

Stopping therapy
because of an
adverse event does
not represent anerror or intentional
misuse.
Discontinuation oftherapy is typically
captured as an
outcome.

No

Treatment
noncompliance

Yes

Missed dose in error
Drug delivery device
fell off skin

Yes

Capture theunintentional missed
dose and that it
occurred because
the delivery device
fell off. In this case it
is not stated whether
this is an adhesion
issue.

Forgot to take product3.2.3.2 Other administration errors/issues
Scenario
Medication
LLT
error?
Patient accidentally took
Yes
Once daily dose
1 tablet twice daily
taken more
instead of the prescribedfrequently
1 tablet once daily

Comment
When available, it isimportant to select a
specific LLT for thereported scenario,
rather than just the LLTthat matches the PT
Inappropriate scheduleof productadministration, allowing
further sub-analyses
on the LLT level.
Although the LLT does
not capture that it was
accidental, it falls
under HLT Product23

Scenario

Medication
error?

LLT

Comment
administration errors
and issues.

Tablet was crumbled,
but was stilladministered to thepatient

Yes,
consequent
to a productquality issue

Patient had difficulty
removing the tablet fromthe thick blister pack;she managed to force itout but the tablet
crumbled into manypieces that fell to thefloor. She found andtook only one piece ofthe dose.
Syringe plunger couldn’t
be completely pushed
down so the patient
received only half of hisscheduled doseYes

A patient reported that
he followed the
directions for use, but
the device jammed andmost of the injection
sprayed all over his
hands

Tablet physical issue “Tablet was crumbled”
in this scenario is a
product
quality issue
Poor quality drug
(LLT Tablet physicaladministeredissue); do not select a
medication error termsuch as LLT Tablet
crushed incorrectly.
The error is that a
product with a known
quality issue(“crumbled”) was stilladministered to thepatient.
Product blister“Tablet crumbled” inpackaging issue
this scenario is not a
product quality issue
anddoes not need toIncorrect dosebecoded.
Code theadministeredreported blister
packaging issue andthe consequent partial
dose administration.

Yes,
consequent
to a delivery
device issue

Device delivery
system malfunction

Yes,
consequent
to a delivery
device issue

Device delivery
system malfunction

Incorrect dose
administered bydeviceAccidental exposure
while administering
drug

Capture both thedevice issue and theconsequent medication
error. LLT Device
delivery system
malfunction is more
specific than LLTSyringe issue.
Do not infer a missed
dose, since it is notreported in the
narrative

Exposure via skincontact
24

Scenario
Patient taking
contraindicated drug

Medication
error?
Unknown

LLT

Comment

Contraindicated drug The report states thatadministered
the patient is taking acontraindicated drug;
circumstances are notprovided
Drug administered atinappropriate site

The drug wasadministered in theabdomen rather than thearm muscle asrecommended
Patient inquired about
possible overdose
symptoms because she
accidentally took an
extra dose

Unknown

Yes

Extra dose
administered

Patient reported taking
an expired drug for his
headache
Patient experienced
respiratory arrest after
the nurse
misprogrammed theinfusion pump to deliver
the drug over 5 minutes
instead of the intended
50 minutes
The patient used acracked insulin cartridge
which resulted in apartial dose
administered

Unknown

Expired drug used

Yes

Drug administration
rate too fast

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

Pump programmingerror
Respiratory arrest
Yes

Partial dose delivery
by device

3.2.4 Product confusion errors/issues
Scenario
Medication
error?
Patient was dispensed
Yes
Drug Y instead of Drug
X. The two drugs had

Cartridge cracked

LLT

Comment

Look alikepackaging25

Scenario

Medication
error?

similar looking
packaging.

LLT

Comment

Wrong drug
dispensed

Patient purchased overthe counter (OTC) Drug
X 10 g instead ofintended Drug X 5 g
because of label
confusion
Patient accidentally took
the wrong drug for aweek because thetablets looked identicalto his daily vitamin
tablets
Mix-up of 5 mg/ml with50 mg/ml product

Yes

Product label
confusion

Yes

Wrong strength

Patient was dispensed‘Drillo’ instead of ‘Millo’,
as the pharmacist
misheard the name ofthe drug as ‘Drillo” when
the physician ordered itover the telephone
Patient experienced skinulceration after applying
the wrong topical cream.
Error attributed to thecreams packaged in thesame size tube withsimilar red font and black
background.

Yes

Drug name soundalike

Wrong drug strength
selected
Yes

Look alike pill
appearance
Wrong drug
administered
It is unclear whether
the patient wasadministered the drug.
‘Strength’ pertains to
the product itself; ‘dose’is the amount of drug
the patient receives /should receive.

Wrong drug
dispensed
Yes

3.2.5 Dispensing errors/issues
Scenario
Medication
error?
Patient complained thatNo
the generic didn’t work

Look alikepackagingWrong drug
administered
Skin ulceration

LLT

Comment

Product substitution
issue brand to
generic

This is a productquality complaint26

Scenario

Medication
error?

as well as the innovator
drug
A generic wassubstituted for the brandname productUnknown

LLT

Drug effectdecreased
Product substitution
Code only what is(HLT Therapeutic stated. The report does
procedures NEC)not specify an error.

Patient received expired
patches from thepharmacy
Patient took the drug
daily instead of on theintended weekly
schedule because theclinic wrote the wrong
directions on the vial

Yes

Expired drug
dispensed

Yes

Wrong directions
typed on label (PTProduct dispensing
error)

Drug was not dispensed
in the original container,
although the labelling
advises that the drug
must be kept in theoriginal container
The prescription wasillegible and resulted in
the pharmacy
dispensing the wrong
strength

Yes

Pharmacy dispensed
drug with the pharmacy
label obscuring therecommended storage
information. Productstored at wrong
temperature.

Yes

Yes

Comment

Once weekly dosetaken more
frequently
Drug not dispensed
in original container

Wrong drug strength
dispensed

Written prescription
illegible
Drug dispensing
error
Pharmacy label
placed incorrectly(PT Productdispensing error)

Product storage
error

27

3.2.6 Monitoring errors/issues
Scenario
Medication
error?
Patient was hospitalized
Yeswith thromboembolism
because his INR wasn’t
monitored asrecommended in thelabelling
Literature reportNohypothesised a possible
drug interaction caused
the patient to experiencehypotension
Patient experienced typeYes
I hypersensitivity after
receiving amoxicillin
during surgery. The
patient’s e-health record
had a documented
history of amoxicillin
allergy. The error was
attributed to the lack ofinteroperability between
the anaesthesia softwareand the hospital’s ehealth record.
Patient on anticoagulant
Yes
undergoing surgery but
due to an oversight, it
was not stopped prior tosurgery as
recommended in thelabelling and patient
experienced
postoperative bleeding
Provider prescribed twoYes
drugs with known druginteraction because he
was unaware of theinteraction potential

LLT

Comment

Drug monitoringprocedure not
performed
Thromboembolism
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

28

3.2.7 Preparation errors/issues
Scenario
Medication
LLT
Comment
error?
Caregiver wasn’t aware
Yes
Product assembly
to remove the innererror during
cover from an insulin
preparation for use
pen needle when
preparing the pen
Product was
YesWrong solution usedreconstituted with thein drug reconstitution
wrong diluent
Pharmacy compounded
Yes
Product
the wrong strengthcompounding error
product
Wrong strength
Patient received only
Yes
Product preparation
one component of aerror
two-component productbecause the nurse
Single component of
wasn’t aware that thea two-component
two components
product administeredneeded to be mixed
together before
administration
Pharmacy prepared
Yes
Wrong concentration
incorrect concentration
preparedbecause of confusion
related to the way the
Product label
strengths for the two
confusion
active ingredients werestated on the label
The technician didn’t
Yes
Product preparation LLT Product preparation
follow the instructions toerror
error (HLT Productmix the contents of the
preparation errors andvial for 5 minutes after
issues) is more specificreconstitution
than LLT Wrongtechnique in productusage process (HLT
Medication errors,
product use errors andissues NEC)Respiratory therapist
Yes
Product assembly
put the canister in anerror during
inhaler the wrong way
preparation for use

29

3.2.8 Prescribing errors/issues
Scenario
Drug prescribed in error
for unauthorised use

Medication
error?
Yes

Unintentionallyprescribed Drug X
instead of Drug Y
because the names
sounded alike

Yes

Prescribed 4 mg/kg
instead of 0.4 mg/kg.
Prescriber realised
immediately and called
nurse but nurse hadalready administered the
drug.
Patient was switched todifferent insulin productbut dose adjustment was
not written on theprescription. Patient
administered the wrong
dose and experienced
hypoglycaemia.

Yes

Patient was prescribed 2times the appropriate
dose due tocomputerised prescriber
order entry (CPOE) error
Patient with intractableseizures and taking
multiple drugs wasprescribed acontraindicated drug
Patient was prescribed
0.5 mg to be taken by
splitting the 1 mg tablet

Yes

LLT

Comment

Drug prescribing
errorThis is a prescribing
error. Off label use
should not be coded inaddition. Off label use isan intentional act not anerror.
It is important to be able
to identify the confusion
as a root cause

Drug prescribing
error
Drug name soundalike
Drug doseprescribing error

Even though the error
was detected it was notintercepted in time

Wrong dose
administered
Yes

Drug doseprescribing error
Wrong dose
administered
Hypoglycaemia
Drug doseprescribing error
CPOE error

Unknown

Unknown

Contraindicateddrug prescribed

LLT Seizures should be
captured as medical
history

No event to code basedon the stated information.
It is not known if this is aprescribing error, off label
use, or neither. If this is
the ONLY information,
30

Scenario

Medication
error?

LLT

Comment
this is not a case andshould not be recorded.

Patient prescribed 1
tablet daily for insomnia
for many years. The
product directions statethat the product should
not be taken for morethan 2 weeks.
An elderly man felt dizzyand fell after he wasinappropriately
prescribed Drug A

Unknown

Patient hospitalised forwithdrawal symptoms
after his unspecified
opioids were
inappropiately
downtitrated
Patient prescribed 0.25
mg (off-label startingdose)
Physician ordered thewrong rate ofadministration for the IVdrug, and the patient
experienced hypotension

Unknown

Drug indicated for IV
administration was used
off label via the oral
route

Unknown

Medically
The selected LLTprescribed
captures both theprolongation of"prescribing" concept andlabelled treatment
the "duration" concept
duration (PTProduct prescribing
issue)
Inappropriate
Select LLT Inappropriateprescribingprescribing only when
specifically stated in the
narrative; otherwise,
Dizzyselect LLT Productprescribing issue or aFallsimilar term when it isunknown if the productwas prescribed off label
or in error
Opiate withdrawal
symptoms
Inappropriate drug
titration

No

Off label dosing

Yes

Incorrect drug
administration rate
Hypotension

No

Drug prescribing
error
Off label use
Intravenous
formulation
administered byother route

LLT Intravenous
formulation administeredby other route (PTIncorrect route of productadministration, HLT
Product administration
errors and issues)
provides additional
information about the
specific type of off label
31

Scenario

Medication
error?

LLT

Comment
use. The term is not an
off label use term itself; itis a general product use
issue term that can beused in combination withother terms to capture
detail about off label use,
misuse, medication
errors, etc.

Patient accidentallyreceived duplicate
therapy because theprescriber didn’t realisethe 2 drugs had thesame active ingredient

Yes

Duplicate drugprescription error
Duplicate therapy
with same active
substance

3.2.9 Product selection errors/issues
Scenario
Medication
LLT
error?
The elderly patient
Yes
Product selection
confirmed that due to theerrorcataract, the patient did
not see well and ended
up buying the infant
formulation
Pharmacist selected theYes
Intercepted wrong
wrong drug because of
drug selectedname confusion, but theerror was caught andDrug namecorrected before theconfusion
drug was dispensed
The hospital selected theYes
Wrong productwrong bag and theselectedpatient received atransfusion of the wrong
Transfusion withblood type prior to andincompatible blood
during surgery
Clerk ordered the wrong
Yes
Wrong drug
drug from the wholesaler
selected
because the drugs werelisted next to each other
Drug name lookin the catalogue and thealikenames looked very
similarComment
This is not a productname confusion.
Cataract would be
captured as medical
history.
It is important to capture
the cause of the error

323.2.10 Product storage errors/issues
Scenario
Medication
LLT
Comment
error?
Healthcare facility
Yes
Improper storage of
LLT Poor quality drug
reported storing
unused productadministered should notreconstituted drug in
be selected because thesyringes past the
selected LLT Expired drug
Expired drug
recommended 30 days,
administered is moreadministeredand administering it tospecificpatients. One of these
Lack of drug effectsyringes was used by apatient who reported
that the drug didn’t work.
Vaccine product was
Yes
Product storage
This is a medication error,
stored in the pharmacy
error temperatureas the error occurred in
at excessive
too high
the product use systemtemperatures
The pharmacy staff
member could not finddrug as it had
inadvertently beenplaced on the wrong
shelf
Boxes of the drug sentfrom the manufacturer
were left outside atexcessive temperatures
over the weekend when
the wholesaler was
closedYes

Pharmacy delivered thedrug to the patient’s
home while the patient
was hospitalised. The
package was outside attemperatures below
freezing for two days
(drug should not befrozen).
Manufacturer issued arecall of certain lots ofDrug X that were foundto be exposed toinappropriate storage

Yes

No

No

Drug stored inwrong location

Manufacturing
This storage problem is
product storage
not a medication error
issue (HLT Product because it occurred under
distribution andmanufacturing distribution
storage issues,and storage activities,
SOC Productprior to the productissues).
reaching the medication
use system
Product storage
This is a medication error,
error temperatureas the error occurred in
too low
the product use system

Manufacturing
product storage
issue
Recalled productThis storage problem is
not a medication error
because it occurred under
manufacturing distribution
and storage activities,
prior to the product33

Scenario

Medication
error?

LLT

conditions by thewholesaler
Pharmacy mistakenly
stocked the wrong drugin the automateddispensing system.
Reporter attributed theerror to both drugs being
packaged in similar
sized vials with lookalike container labels.

Comment
reaching the medication
use system

Yes

Drug label lookalike
Wrong drug
stockedProduct packaging
confusion

3.2.11 Product transcribing errors/communication issues
Scenario
Medicati
LLT
Comment
onerror?
Healthcare provider called
Yes
Transcription
in a prescription for Drug A,
medication error
but pharmacy wrote down
the prescription as Drug B
Pharmacy dispensed 800
Yes
Product data entry
mg strength instead of 600
error
mg due to data entry error
Wrong drug
strengthdispensed
Physician ordered insulin
Yes
Transcription
pens, but a transcription
medication error
error transpired with thepharmacy and the patientWrong device
was dispensed insulin in adispensed
vial with syringes instead
Patient had an issue
No
Communication Despite the terms “issue”
communicating and wasdisorderand “communicating” ingiven the possible
the example, this is not adiagnosis of autism
medication error andAutismshould not be captured
under LLT Productcommunication issue, butrather should be captured
under LLT
Communication disorder34