SECTION 3 – TERM SELECTION POINTS

3.1 Definitive and Provisional Diagnoses with or without Signs and Symptoms

The table below provides term selection options for definitive and provisional diagnoses with or without signs/symptoms reported. Examples are listed below the table.

A provisional diagnosis may be described as “suspicion of”, “probable”, “presumed”, likely”, “rule out”, “questionable”, “differential”, etc.

The preferred option for a single or multiple provisional diagnosis(es) is to select a term(s) for the diagnosis(es) and terms for reported signs and symptoms. This is because a provisional diagnosis may change while signs/symptoms do not.

SUMMARY OF PREFERRED AND ALTERNATE OPTIONS

SINGLE DIAGNOSIS

DEFINITIVE DIAGNOSIS

PROVISIONAL DIAGNOSIS

Single definitive diagnosis
without signs/symptoms

· Diagnosis (only possible option)

Single provisional diagnosis
without signs/symptoms

· Provisional diagnosis (only possible option)

Single definitive diagnosis
with signs/symptoms

· Preferred : Diagnosis only

· Alternate: Diagnosis and signs/symptoms

Note: Always include signs/symptoms not associated with diagnosis

SEE EXAMPLE 1

Single provisional diagnosis
with signs/symptoms

· Preferred : Provisional diagnosis and signs/symptoms

· Alternate: Signs/symptoms only

Note: Always include signs/symptoms not associated with diagnosis

SEE EXAMPLE 2

MULTIPLE DIAGNOSES

DEFINITIVE DIAGNOSES

PROVISIONAL DIAGNOSES

Multiple definitive diagnoses
without signs/symptoms

· Multiple diagnoses (only possible option)

Multiple provisional diagnoses
without signs/symptoms

· Multiple provisional diagnoses (only possible option)

Multiple definitive diagnoses
with signs/symptoms

· Preferred : Multiple diagnoses only

· Alternate: Diagnoses and signs/symptoms

Note: Always include signs/symptoms not associated with diagnosis

SEE EXAMPLE 3

Multiple provisional diagnoses
with signs/symptoms

· Preferred : Multiple provisional diagnoses and signs/symptoms

· Alternate: Signs/symptoms only

Note: Always include signs/symptoms not associated with diagnosis

SEE EXAMPLE 4

EXAMPLES
Example	Reported	LLT Selected	Preferred Option
1	Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm	Anaphylactic reaction	ü
1		Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm
2	Possible myocardial infarction with chest pain, dyspnoea, diaphoresis	Myocardial infarction Chest pain Dyspnoea Diaphoresis	ü
2		Chest pain Dyspnoea Diaphoresis
3	Pulmonary embolism, myocardial infarction, and congestive heart failure with chest pain, cyanosis, shortness of breath, and blood pressure decreased	Pulmonary embolism Myocardial infarction Congestive heart failure	ü
3		Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased
4	Chest pain, cyanosis, shortness of breath, and blood pressure decreased. Differential diagnosis includes pulmonary embolism, myocardial infarction, and congestive heart failure.	Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased	ü
4		Chest pain Cyanosis Shortness of breath Blood pressure decreased
Always include signs/ symptoms not associated with diagnosis	Myocardial infarction, chest pain, dyspnoea, diaphoresis, ECG changes and jaundice	Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction)

3.2 Death and Other Patient Outcomes

Death, disability, and hospitalisation are considered outcomes or seriousness criteria in the context of safety reporting and not usually considered ARs/AEs. Outcomes and seriousness criteria are typically recorded in a separate manner (data field) from AR/AE information. A term for the outcome or seriousness criterion should be selected if it is the only information reported or provides significant clinical information.

(For reports of suicide and self-harm, see Section 3.3).

3.2.1 Death with ARs/AEs

Death is an outcome and seriousness criterion and is not usually considered an AR/AE. If ARs/AEs are reported along with death, select terms for the ARs/AEs. Record the fatal outcome in an appropriate data field.

Example

Reported

LLT Selected

Comment

Death due to myocardial infarction

Myocardial infarction

Record death as an outcome and seriousness criterion

Constipation, ruptured bowel, peritonitis, sepsis; patient died

Constipation

Perforated bowel

Peritonitis

Sepsis

3.2.2 Death as the only reported information

If the only information reported is death, select the most specific death term available. Circumstances of death should not be inferred but recorded only if stated by the reporter.

Death terms in MedDRA are linked to HLGT Fatal outcomes.

Example

Reported	LLT Selected
Patient was found dead.	Found dead
Patient died in childbirth.	Maternal death during childbirth
The autopsy report stated that the cause of death was natural.	Death from natural causes

3.2.3 Death terms that add important clinical information

Death terms that add important clinical information should be selected along with any reported ARs/AEs.

Example

Reported

LLT Selected

Patient experienced a rash and had sudden cardiac death.

Rash

Sudden cardiac death

3.2.4 Other patient outcomes (non-fatal)

Hospitalisation, disability, and other patient outcomes are not generally considered ARs/AEs.

Example

Reported	LLT Selected	Comment
Hospitalisation due to congestive heart failure	Congestive heart failure	Record hospitalisation as a seriousness criterion

If the only information reported is the patient outcome or seriousness criterion, select the most specific term available.

Example

Reported	LLT Selected
Patient was hospitalised	Hospitalisation

3.3 Suicide and Self-Harm

Accurate and consistent term selection for reports of suicide attempts, completed suicides, and self-harm is necessary for data retrieval and analysis. If the motive for reported injury is not clear, seek clarification from the source.

3.3.1 If overdose is reported

Do not assume that an overdose – including an intentional overdose – is a suicide attempt. Select only the appropriate overdose term (see Section 3.18).

3.3.2 If self-injury is reported

For reports of self-injury that do not mention suicide or suicide attempt, select only the appropriate self-injury term.

Example

Reported	LLT Selected	Comment
Self slashing	Self inflicted laceration	LLT Self inflicted laceration is linked to PT Intentional self-injury
Cut her own wrists	Self inflicted laceration
Cut wrists in a suicide attempt	Self inflicted laceration Suicide attempt
Took an overdose in an attempt to commit suicide	Intentional overdose Suicide attempt	If overdose is reported in the context of suicide or a suicide attempt, the more specific LLT Intentional overdose can be selected (see also Section 3.18)

3.3.3 Fatal suicide attempt

If a suicide attempt is fatal, select the term that reflects the outcome instead of the attempt only.

Example

Reported	LLT Selected	Comment
Suicide attempt resulted in death	Completed suicide	Record death as an outcome and seriousness criterion.

3.4 Conflicting/Ambiguous/Vague Information

When conflicting, ambiguous, or vague information is reported, term selection to support appropriate data retrieval may be difficult. When this occurs, attempt to obtain more specific information. If clarification cannot be achieved, select terms as illustrated in the examples below (Sections 3.4.1 through 3.4.3).

3.4.1 Conflicting information

Example

Reported	LLT Selected	Comment
Hyperkalaemia with a serum potassium of 1.6 mEq/L	Serum potassium abnormal	LLT Serum potassium abnormal covers both of the reported concepts (note: serum potassium of 1.6 mEq/L is a low result, not high)

3.4.2 Ambiguous information

Example

Reported	LLT Selected	Comment
GU pain	Pain	Effort should be made to obtain clarification of the meaning of "GU" from the source so that more specific term selection may be possible. “GU” could be either “genito-urinary” or “gastric ulcer”. If additional information is not available, then select a term to reflect the information that is known, i.e., LLT Pain

3.4.3 Vague information

For information that is vague, attempt to obtain clarification. If clarification cannot be achieved, select an LLT that reflects the vague nature of the reported event.

Example

Reported	LLT Selected	Comment
Turned green	Unevaluable event	“Turned green” reported alone is vague; this could refer to a patient condition or even to a product (e.g., pills)
Patient had a medical problem of unclear type	Ill-defined disorder	Since it is known that there is some form of a medical disorder, LLT Ill-defined disorder can be selected

3.5 Combination Terms

A combination term in MedDRA is a single medical concept combined with additional medical wording that provides important information on pathophysiology or aetiology. A combination term is an internationally recognised, distinct and robust medical concept as illustrated in the examples below.

Example

MedDRA Combination Terms

PT Diabetic retinopathy

PT Hypertensive cardiomegaly

PT Eosinophilic pneumonia

A combination term may be selected for certain reported ARs/AEs (e.g., a condition “due to” another condition), keeping the following points in mind (Note: medical judgment should be applied):

3.5.1 Diagnosis and sign/symptom

If a diagnosis and its characteristic signs or symptoms are reported, select a term for the diagnosis (see Section 3.1). A MedDRA combination term is not needed in this instance.

Example

Reported	LLT Selected
Chest pain due to myocardial infarction	Myocardial infarction

3.5.2 One reported condition is more specific than the other

If two conditions are reported in combination, and one is more specific than the other, select a term for the more specific condition.

Example

Reported	LLT Selected
Hepatic function disorder (acute hepatitis)	Hepatitis acute
Arrhythmia due to atrial fibrillation	Atrial fibrillation

3.5.3 A MedDRA combination term is available

If two conditions or concepts are reported in combination, and a single MedDRA combination term is available to represent them, select that term.

Example

Reported	LLT Selected
Retinopathy due to diabetes	Diabetic retinopathy
Rash with itching	Itchy rash
Breast cancer (HER2 positive)	HER2 positive breast cancer

3.5.4 When to “split” into more than one MedDRA term

If “splitting” the reported ARs/AEs provides more clinical information, select more than one MedDRA term. For example, in the field of oncology, there may be situations in which it is important to capture information not only for the tumour type, but also for the associated genetic marker or abnormality because of the implications for aetiology, prognosis or treatment. If a combination term that describes a genetic marker or abnormality associated with a medical condition is not available, separate terms may be selected to represent the genetic marker or abnormality as well as the associated medical condition.

Example

Reported	LLT Selected
Diarrhoea and vomiting	Diarrhoea Vomiting
Wrist fracture due to fall	Wrist fracture Fall
BRAF positive malignant melanoma	BRAF gene mutation Malignant melanoma

Exercise medical judgment so that information is not lost when “splitting” a reported term. Always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information.

Example

Reported

LLT Selected

Comment

Haematoma due to an animal bite

Animal bite

Traumatic haematoma

LLT Traumatic haematoma is more appropriate than LLT Haematoma (LLT Traumatic haematoma links to HLT Non-site specific injuries NEC and HLT Haemorrhages NEC while LLT Haematoma links only to HLT Haemorrhages NEC)

3.5.5 Event reported with pre-existing condition

If an event is reported along with a pre-existing condition that has not changed, and if there is not an appropriate combination term in MedDRA, select a term for the event only (see Section 3.9 for pre-existing conditions that have changed).

Example

Reported	LLT Selected	Comment
Shortness of breath due to pre-existing cancer	Shortness of breath	In this instance, “shortness of breath” is the event; “cancer” is the pre-existing condition that has not changed

3.6 Age vs. Event Specificity

3.6.1 MedDRA term includes age and event information

Example

Reported	LLT Selected
Jaundice in a newborn	Jaundice of newborn
Developed psychosis at age 6 years	Childhood psychosis

3.6.2 No available MedDRA term includes both age and event information

The preferred option is to select a term for the event and record the age in the appropriate demographic field.

Alternatively, select terms (more than one) that together reflect both the age of the patient and the event.

Example

Reported

LLT Selected

Preferred Option

Pancreatitis in a newborn

Pancreatitis

Neonatal disorder

3.7 Body Site vs. Event Specificity

3.7.1 MedDRA term includes body site and event information

Example

Reported	LLT Selected
Skin rash on face	Rash on face

3.7.2 No available MedDRA term includes both body site and event information

Select a term for the event, rather than a term that reflects a non-specific condition at the body site; in other words, the event information generally has priority.

Example

Reported	LLT Selected	Comment
Skin rash on chest	Skin rash	In this instance, there is no available term for a skin rash on the chest

However, medical judgment is required, and sometimes, the body site information should have priority as in the example below.

Example

Reported	LLT Selected	Comment
Cyanosis at injection site	Injection site discolouration	Cyanosis may suggest a generalised disorder. In this example, selecting LLT Cyanosis would result in loss of important medical information and miscommunication.

3.7.3 Event occurring at multiple body sites

If an event is reported to occur at more than one body site, and if all of those LLTs link to the same PT, then select a single LLT that most accurately reflects the event; in other words, the event information has priority.

Example

Reported	LLT Selected	Comment
Skin rash on face and neck	Skin rash	LLT Rash on face, LLT Neck rash, and LLT Skin rash all link to PT Rash
Oedema of hands and feet	Oedema of extremities	LLT Oedema hands and LLT Oedematous feet both link to PT Oedema peripheral. However, LLT Oedema of extremities most accurately reflects the event in a single term

3.8 Location-Specific vs. Microorganism-Specific Infection

3.8.1 MedDRA term includes microorganism and anatomic location

Example

Reported	LLT Selected	Comment
Pneumococcal pneumonia	Pneumococcal pneumonia	In this example, the implied anatomic location is the lung

3.8.2 No available MedDRA term includes both microorganism and anatomic location

The preferred option is to select terms for both the microorganism-specific infection and the anatomic location.

Alternatively, select a term that reflects the anatomic location or select a term that reflects the microorganism-specific infection. Medical judgment should be used in deciding whether anatomic location or the microorganism-specific infection should take priority.

Example

Reported	LLT Selected	Preferred Option	Comment
Klebsiella kidney infection	Klebsiella infection Kidney infection	ü	Represents both microorganism-specific infection and anatomic location
	Kidney infection		Represents location-specific infection
	Klebsiella infection		Represents microorganism-specific infection

3.9 Modification of Pre-existing Conditions

Pre-existing conditions that have changed may be considered ARs/AEs, especially if the condition has worsened or progressed (see Section 3.5.5 for pre-existing conditions that have not changed, and Section 3.22 for an unexpected improvement of a pre-existing condition).

Ways That Pre-existing Conditions May Be Modified

Aggravated, exacerbated, worsened

Recurrent

Progressive

Select a term that most accurately reflects the modified condition (if such term exists)

Example

Reported	LLT Selected
Exacerbation of myasthenia gravis	Myasthenia gravis aggravated

If no such term exists, consider these approaches:

• Example 1: Select a term for the pre-existing condition and record the modification in a consistent, documented way in appropriate data fields

• Example 2: Select a term for the pre-existing condition and a second term for the modification of the condition (e.g., LLT Condition aggravated, LLT Disease progression). Record the modification in a consistent, documented way in appropriate data fields.

Example

Examples

Reported

LLT Selected

Comment

Example 1

Jaundice aggravated

Jaundice

Record “aggravated” in a consistent, documented way.

Example 2

Jaundice aggravated

Jaundice

Condition aggravated

Record “aggravated” in a consistent, documented way. Select terms for the pre-existing condition and the modification.

3.10 Exposures during Pregnancy and Breast Feeding

To select the most appropriate exposure term (or terms) from HLT Exposures associated with pregnancy, delivery and lactation , first determine if the subject/patient who was exposed is the mother, the child/foetus, or the father. If the reported verbatim information does not specify who was exposed, then a general term such as LLT Exposure during pregnancy can be selected.

In addition, MedDRA includes terms indicating a pregnant or breastfeeding woman was exposed, which are placed in HLTs other than HLT Exposures associated with pregnancy, delivery and lactation . These terms include e.g., PT Maternal immunisation , PT Maternal therapy to enhance foetal lung maturity and PT Maternal-foetal therapy , as well as several PTs relating to pregnancy on contraceptive. Selecting pregnancy/breast-feeding exposure terms may be considered in addition, depending on the specific circumstances of each case.

3.10.1 Events in the mother

3.10.1.1 Pregnant patient exposed to medication with clinical consequences

If a pregnancy exposure is reported with clinical consequences, select terms for both the pregnancy exposure and the clinical consequences.

Example

Reported

LLT Selected

Pregnant patient receiving drug X experienced a pruritic rash

Maternal exposure during pregnancy

Pruritic rash

3.10.1.2 Pregnant patient exposed to medication without clinical consequences

If a pregnancy exposure report specifically states that there were no clinical consequences, the preferred option is to select only a term for the pregnancy exposure. Alternatively, a term for the pregnancy exposure and the additional LLT No adverse effect can be selected (see Section 3.21).

Example

Reported

LLT Selected

Preferred Option

Patient received drug X while pregnant (no adverse effect)

Maternal exposure during pregnancy

No adverse effect

3.10.2 Events in the child or foetus

Select terms for both the type of exposure and any adverse event(s).

Example

Reported	LLT Selected
Pregnant woman taking drug X; foetal tachycardia noted on routine examination	Maternal exposure during pregnancy Foetal tachycardia
Baby born with cleft palate; father had been taking drug X before conception	Paternal drug exposure before pregnancy Cleft palate
Nursing newborn exposed to drug X through breast milk; experienced vomiting	Drug exposure via breast milk Vomiting neonatal

3.11 Congenital Terms

“Congenital” = any condition present at birth, whether genetically inherited or occurring in utero (see the MedDRA Introductory Guide).

3.11.1 Congenital conditions

Select terms from SOC Congenital, familial and genetic disorders when the reporter describes the condition as congenital or when medical judgment establishes that the condition was present at the time of birth.

Example

Reported	LLT Selected	Comment
Congenital heart disease	Heart disease congenital
Child born with heart disease	Heart disease congenital
Newborn with phimosis	Phimosis	A “congenital” term is not available but LLT/PT Phimosis links to primary SOC Congenital, familial and genetic disorders

3.11.2 Acquired conditions (not present at birth)

If information is available indicating that the condition is not congenital or present at birth, i.e., it is acquired, select the non-qualified term for the condition, making sure that the non-qualified term does not link to SOC Congenital, familial and genetic disorders . If a non-qualified term is not available, select the “acquired” term for the condition.

Example

Reported	LLT Selected	Comment
Developed night blindness in middle age	Night blindness	LLT/PT Night blindness links to primary SOC Eye disorders. Do not assume the condition is congenital (LLT/PT Congenital night blindness ).
Developed phimosis at age 45	Acquired phimosis	LLT/PT Phimosis should not be selected because it links to primary SOC Congenital, familial and genetic disorders
34 year old patient diagnosed with an oesophageal web	Acquired oesophageal web	A non-qualified term “Oesophageal web” is not available. It cannot be assumed that the condition was present at birth so it is appropriate to select the acquired term.

3.11.3 Conditions not specified as either congenital or acquired

If a condition is reported without any information describing it as congenital or acquired, select the non-qualified term for the condition. For conditions or diseases existing in both congenital and acquired forms, the following convention is applied in MedDRA: the more common form of the condition/disease is represented at the PT level without adding a qualifier of either “congenital” or “acquired”.

Example

Reported	LLT Selected	Comment
Pyloric stenosis	Pyloric stenosis	Pyloric stenosis is more commonly congenital than acquired; LLT/PT Pyloric stenosis links to primary SOC Congenital, familial and genetic disorders
Hypothyroidism	Hypothyroidism	Hypothyroidism is more commonly acquired than congenital; LLT/PT Hypothyroidism links to primary SOC Endocrine disorders

3.12 Neoplasms

Due to the large number of neoplasm types, specific guidance cannot be provided for all situations. The MedDRA Introductory Guide describes the use and placement of neoplasm terms and related terms in MedDRA.

Keep in mind the following points:

Neoplasms Terms in MedDRA

“Cancer” and “carcinoma” are synonyms (see online MedDRA Concept Descriptions which can be accessed via the Web-Based Browser and MedDRA Desktop Browser)

“Tumo(u)r” terms refer to neoplasia

“Lump” and “mass” terms are not neoplasia

If the type of neoplasia is not clear, seek clarification from the reporter. Consult medical experts when selecting terms for difficult or unusual neoplasms.

3.12.1 Do not infer malignancy

Select a malignancy term only if malignancy is stated by the reporter. Reports of “tumo(u)r” events should not be assigned a “cancer”, “carcinoma” or another malignant term unless it is clear that malignancy is present.

Example

Reported	LLT Selected
Tumour growing on skin	Skin tumour
Cancer growing on tongue	Malignant tongue cancer

3.13 Medical and Surgical Procedures

Terms in SOC Surgical and medical procedures are generally not appropriate for ARs/AEs. Terms in this SOC are not multiaxial. Be aware of the impact of these terms on data retrieval, analysis, and reporting.

Keep in mind the following points:

3.13.1 Only the procedure is reported

If only a procedure is reported, select a term for the procedure.

Example

Reported	LLT Selected
Patient had transfusion of platelets	Platelet transfusion
Patient had tonsillectomy in childhood	Tonsillectomy

3.13.2 Procedure and diagnosis are reported

If a procedure is reported with a diagnosis, the preferred option is to select terms for both the procedure and diagnosis. Alternatively, select a term only for the diagnosis.

Example

Reported

LLT Selected

Preferred Option

Comment

Liver transplantation due to liver injury

Liver transplantation

Liver injury

Selecting term for the procedure may indicate severity of the condition

Liver injury

3.14 Investigations

SOC Investigations includes test names with qualifiers (e.g., increased, decreased, abnormal, normal) and without qualifiers. Corresponding medical conditions (such as “hyper-” and “hypo-” terms) are in other “disorder” SOCs (e.g., SOC Metabolism and nutrition disorders).

SOC Investigations is not multiaxial; always consider the terms in this SOC for data retrieval.

3.14.1 Results of investigations as ARs/AEs

Keep in mind the following points when selecting terms for results of investigations:

• Selecting terms for a medical condition vs. an investigation result

Example

Reported	LLT Selected	Comment
Hypoglycaemia	Hypoglycaemia	LLT Hypoglycaemia links to SOC Metabolism and nutrition disorders
Decreased glucose	Glucose decreased	LLT Glucose decreased links to SOC Investigations

• Unambiguous investigation result

Example

Reported	LLT Selected	Comment
Glucose 40 mg/dL	Glucose low	Glucose is clearly below the reference range

• Ambiguous investigation result

Example

Reported	LLT Selected	Comment
His glucose was 40	Glucose abnormal	In this example, no units have been reported. Select LLT Glucose abnormal if clarification cannot be obtained

3.14.2 Investigation results consistent with diagnosis

When investigation results are reported with a diagnosis, select only a term for the diagnosis if investigation results are consistent with the diagnosis.

Example

Reported	LLT Selected	Comment
Elevated potassium, K 7.0 mmol/L, and hyperkalaemia	Hyperkalaemia	It is not necessary to select LLT Potassium increased

3.14.3 Investigation results not consistent with diagnosis

When investigation results are reported with a diagnosis, select a term for the diagnosis and also select terms for any investigation results that are not consistent with the diagnosis.

Example

Reported

LLT Selected

Comment

Alopecia, rash, and elevated potassium 7.0 mmol/L

Alopecia

Rash

Potassium increased

Elevated potassium is not consistent with the diagnoses of alopecia and rash. Terms for all concepts should be selected.

3.14.4 Grouped investigation result terms

Select a term for each investigation result as reported; do not “lump” together separate investigation results under an inclusive term unless reported as such.

Example

Reported

LLT Selected

Comment

Abnormalities of liver function tests

Abnormal liver function tests

Increased alkaline phosphatase, increased SGPT, increased SGOT and elevated LDH

Alkaline phosphatase increased

SGPT increased

SGOT increased

LDH increased

Select four individual terms for the investigation results. A single term such as LLT Liver function tests abnormal should not be selected

3.14.5 Investigation terms without qualifiers

Terms in SOC Investigations without qualifiers are intended to be used to record test names when entering diagnostic test data in the ICH E2B electronic transmission standard.

Example

Information/Reported (Verbatim)	LLT Selected for Test Name	Comment
Cardiac output measured	Cardiac output
Haemoglobin 7.5 g/dL	Haemoglobin	LLT Haemoglobin decreased should not be selected as it is both a test name and a result*

* MedDRA is used only for test names, not test results, in the E2B data elements for Results of Tests and Procedures

Test name terms without qualifiers are not intended for use in other data fields capturing information such as ARs/AEs and medical history. The use of the Unqualified Test Name Term List is optional and may be used to identify the inappropriate selection of these terms in data fields other than the test name data element. It is available for download from the MedDRA and JMO websites.

3.15 Medication Errors, Accidental Exposures and Occupational Exposures

3.15.1 Medication errors

For the purposes of term selection and analysis of MedDRA-coded data, medication errors are defined as any unintentional and preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer.

The online Concept Descriptions contain descriptions of the interpretation and use of certain medication error terms (e.g., “Dispensing error”).

For further information, please refer to Section 3 of the MedDRA Points to Consider Companion Document which contains detailed examples, guidance, and “Questions and Answers” on medication errors (see Appendix, Section 4.2 Links and References).

Reports of medication errors may or may not include information about clinical consequences.

3.15.1.1 Medication errors reported with clinical consequences

If a medication error is reported with clinical consequences, select terms for both the medication error and the clinical consequences.

Example

Reported	LLT Selected	Comment
Patient was administered wrong drug and experienced hypotension.	Wrong drug administered Hypotension
Because of similar sounding drug names, the wrong drug was dispensed; as a result, the patient took the wrong drug and experienced a rash.	Wrong drug dispensed Wrong drug administered Drug name sound-alike Rash	The ‘originating’ error (Wrong drug dispensed) and reported additional or ‘consequent’ errors and contributing factors (Drug name sound-alike) stated in the report should all be coded, while not subtracting or inferring information
Insulin preparation was given using the wrong syringe resulting in the administration of an overdose. The patient developed hypoglycaemia.	Drug administered in wrong device Accidental overdose Hypoglycaemia	If an overdose is reported in the context of a medication error, the more specific term LLT Accidental overdose can be selected (see also Section 3.18)

3.15.1.2 Medication errors and potential medication errors reported without clinical consequences

Medication errors without clinical consequences are not ARs/AEs. However, it is important to record the occurrence or potential occurrence of a medication error. Select a term that is closest to the description of medication error reported.

Intercepted medication error : For the purposes of term selection and analysis of MedDRA-coded data, an intercepted medication error refers to the situation where a medication error has occurred, but is prevented from reaching the patient or consumer. The intercepted error term should reflect the stage at which the error occurred, rather than the stage at which it was intercepted.

If a medication error report specifically states that there were no clinical consequences, the preferred 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 Section 3.21).

Example

Reported

LLT Selected

Preferred Option

Intramuscular formulation medication was given intravenously instead of intramuscularly but the patient did not experience any adverse effects.

Intramuscular formulation administered by other route

No adverse effect

Example

Reported	LLT Selected	Comment
Pharmacist notices that the names of two drugs look similar and is concerned that this may result in someone getting a wrong drug	Drug name look-alike Potential for medication error, wrong drug	This example is a potential medication error. LLT Drug name look-alike is a contributing factor, and LLT Potential for medication error, wrong drug indicates that there is a potential medication error including the error type.
The physician prescribed the wrong dose of the drug; the error was identified at the time of dispensing	Intercepted drug prescribing error Drug dose prescribing error	The intercepted error terms reflect the stage at which the error occurred, which is not necessarily the stage at which it was intercepted. Capture the type of error that was intercepted and contributing factors when reported.
The pharmacist dispensed the wrong drug because of a similar label design but the patient realised the error and did not take the drug	Intercepted drug dispensing error Drug label look-alike Wrong drug dispensed
Patient forgot to take his scheduled dose of drug X	Forgot to take product	LLT Forgot to take product (PT Product dose omission in error) is an example of an unintentional dose omission/missed dose. See the Points to Consider Companion Document for additional examples of the various scenarios of dose omissions.
Patient's scheduled dose of drug X was not administered because he was undergoing surgery that day	Intentional dose omission	This is an example of an intentional dose omission/missed dose. It is not a medication error.
Due to Drug X shortage, patient was unable to take her medication for a week	Drug shortage Temporary interruption of therapy	This event is neither intentional nor a medication error. Use LLT Temporary interruption of therapy (PT Therapy interrupted, HLT Therapeutic procedures NEC) and capture the specific external factor which caused the interruption of therapy.

3.15.1.3 Medication monitoring errors

For the purposes of term selection and analysis of MedDRA-coded data, a medication monitoring error is an error that occurs in the process of monitoring the effect of the medication through clinical assessment and/or laboratory data.

It can also refer to monitoring errors in following instructions or information pertinent to the safe use of the medication, such as the specific scenario regarding the term LLT Documented hypersensitivity to administered drug in the example below.

Example

Reported

LLT Selected

Comment

Patient with sulfa allergy documented in patient’s medical file is administered a sulfonamide-based drug and experienced wheezing

Documented hypersensitivity to administered drug

Wheezing

This medication error refers to the situation when a patient is administered a drug that is documented in the patient's medical file to cause a hypersensitivity reaction in the patient.

Example

Reported	LLT Selected	Comment
The patient's liver enzymes were measured every six months instead of the recommended monthly schedule	Drug monitoring procedure incorrectly performed	The monthly monitoring schedule is in the label for this drug. This is an example of incorrect monitoring of laboratory tests recommended in the use of a drug.
Patient taking lithium-based drug did not have his lithium levels measured	Therapeutic drug monitoring analysis not performed	This is an example of not monitoring the therapeutic drug level to ensure that it is within the therapeutic range as recommended in the label for this drug.

There are specific medication error situations when the product is prescribed, dispensed, or co-administered with specific drugs, with specific foods, or to patients with specific disease states, or genetic variants, and the product label describes known noxious effects of these interactions. Select a medication error term for the type of interaction, such as those listed below.

If the report indicates that this is intentional misuse or intentional off label use, select the appropriate terms representing the intentional nature of the event. If the report does not provide information about whether the event was accidental or intentional, select an appropriate interaction issue term, e.g., LLT Labelled drug-drug interaction issue .

Medication Error Terms – Labelled Interactions

Labelled drug-drug interaction medication error

Labelled drug-food interaction medication error

Labelled drug-disease interaction medication error

Labelled drug-genetic interaction medication error

Example

Reported	LLT Selected	Comment
Patient became pregnant whilst taking an antifungal drug and an oral contraceptive. She was unaware of the interaction warning in the label.	Labelled drug-drug interaction medication error Pregnancy on oral contraceptive	Product is labelled for this drug-drug interaction (see also Section 3.20)
Patient drank grapefruit juice by mistake whilst taking a calcium channel blocker.	Labelled drug-food interaction medication error	Product is labelled for this drug-food interaction with grapefruit juice
Patient with renal failure is accidentally prescribed a drug that is contraindicated in renal failure	Labelled drug-disease interaction medication error Contraindicated drug prescribed	Product is labelled for this drug-disease interaction. LLT Contraindicated drug prescribed provides additional information about the nature of the labelled interaction medication error and the stage at which the error occurred.
Patient was inadvertently given a drug that is contraindicated in patients who are cytochrome P450 2D6 poor metabolisers	Labelled drug-genetic interaction medication error Contraindicated drug administered CYP2D6 poor metaboliser status	Product is labelled for this drug-genetic variant interaction

3.15.1.4 Do not infer a medication error

Do not infer that a medication error has occurred unless specific information is provided. This includes inferring that extra dosing, overdose, or underdose has occurred (see Section 3.18).

Example

Reported	LLT Selected	Comment
Patient took only half of the minimum recommended dose in the label	Underdose	Based on this report, it is not known whether the underdose is intentional or accidental. If information is available, select the more specific LLT Accidental underdose or LLT Intentional underdose as appropriate.

3.15.2 Accidental exposures and occupational exposures

3.15.2.1 Accidental exposures

The principles for Section 3.15.1 (Medication errors) also apply to accidental exposures.

Example

Reported

LLT Selected

Comment

Child accidentally took grandmother's pills and experienced projectile vomiting

Accidental drug intake by child

Vomiting projectile

Father applying topical steroid to his arms accidentally exposed his child to the drug by carrying her

Accidental exposure to product by child

Exposure via skin contact

The “exposure to” term captures the agent of exposure, i.e., a product, and the “exposure via” term captures the route/vehicle of exposure, i.e., skin contact

3.15.2.2 Occupational exposures

For the purposes of term selection and analysis of MedDRA-coded data, occupational exposure encompasses the “chronic” exposure to an agent (including therapeutic products) during the normal course of one's occupation, and could include additional scenarios in specific regulatory regions. For example, occupational exposure may additionally relate to a more acute, accidental form of exposure that occurs in the context of one's occupation. In these regions, occupational exposure for healthcare workers could be of particular interest.

Example

Reported	LLT Selected	Comment
Physical therapist developed a photosensitivity rash on hands after exposure to an NSAID-containing pain relief cream that she applied to a patient	Occupational exposure via skin contact with product Photosensitive rash
Pathologist chronically exposed to formaldehyde developed nasopharyngeal carcinoma	Occupational exposure to toxic agent Nasopharyngeal carcinoma	Exposure to formaldehyde is a known risk factor for this type of malignancy
Nurse splashed injectable drug in her own eye resulting in excessive tearing	Accidental contact of product with eye Excess tears	An alternative term – e.g., LLT Occupational exposure to product via eye – could be selected to replace LLT Accidental contact of product with eye , if applicable to regional requirements where acute exposures are considered to be occupational exposures

3.16 Misuse, Abuse and Addiction

The concepts of misuse, abuse and addiction are closely related and can pose challenges for term selection since the terms may overlap to some extent; the specific circumstances of each case/reported event may help in consideration for term selection of these concepts. Medical judgment and regional regulatory considerations need to be applied.

It may also be useful to consider these concepts as shown in the table below:

Concept	Intentional?	By Whom?	Therapeutic Use?	Additional Sections in this Document
Misuse	Yes	Patient/consumer	Yes*	3.16.1
Abuse	Yes	Patient/consumer	No	3.16.2
Addiction	Yes	Patient/consumer	No	3.16.3
The concepts Medication error and Off label use are placed here for comparison reasons:
Medication error	No	Patient/consumer or healthcare professional	Yes	3.15
Off label use	Yes	Healthcare professional	Yes	3.27

* Definitions of misuse may not always include the concept of therapeutic use; misuse may be similar to the concept of abuse in some regions.

Select the most specific term available and always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information. In some cases, it may be appropriate to select more than one MedDRA LLT to represent the reported information.

3.16.1 Misuse

For the purposes of term selection and analysis of MedDRA-coded data, misuse is the intentional use for a therapeutic purpose by a patient or consumer of a product–over-the-counter or prescription – other than as prescribed or not in accordance with the authorised product information.

Example

Reported	LLT Selected
Patient deliberately took the medication twice daily instead of once daily	Intentional misuse in dosing frequency

3.16.2 Abuse

For the purposes of term selection and analysis of MedDRA-coded data, abuse is the intentional, non-therapeutic use by a patient or consumer of a product – over-the counter or prescription – for a perceived reward or desired non‑therapeutic effect including, but not limited to, “getting high” (euphoria). Abuse may occur with a single use, sporadic use or persistent use of the product.

Example

Reported	LLT Selected	Comment
Athlete used anabolic steroid preparation to enhance performance	Steroid abuse
Patient occasionally uses opioid product to get high	Opioid abuse, episodic use
Patient deliberately ingested the topical medication for its psychoactive effect	Drug abuse Intentional use by incorrect route	LLT Intentional use by incorrect route (PT Intentional product use issue ) provides additional information about the nature of the drug abuse

See Section 3.24.1 and 3.24.2 for additional references to “abuse” terms in MedDRA.

3.16.3 Addiction

For the purposes of term selection and analysis of MedDRA-coded data, addiction is an overwhelming desire by a patient or consumer to take a drug for non-therapeutic purposes together with inability to control or stop its use despite harmful consequences. Addiction can occur because drug induces physical dependence and consequently a withdrawal syndrome, but this is not an essential feature; and addiction can occur because of a desire to experience the drug's psychological, behavioural or physical effects.

Example

Reported

LLT Selected

Patient became dependent on crack cocaine

Dependence on cocaine

Patient became addicted to a deliberately ingested topical medication for its psychoactive effect

Drug addiction

Intentional use by incorrect route

See Section 3.24.1 for additional references to “addict/addiction” terms in MedDRA.

3.16.4 Drug diversion

For the purposes of term selection and analysis of MedDRA-coded data, drug diversion means that a drug is diverted from legal and medically necessary uses toward illegal uses.

Example

Reported	LLT Selected
Pharmacist stole medications from the pharmacy and sold them to others for recreational use	Drug diversion
The patient sold his controlled drug prescription to another person	Drug diversion

3.17 Transmission of Infectious Agent via Product

If a report of transmission of an infectious agent via a product is received, select a term for the transmission. If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (see Section 3.28).

Example

Reported

LLT Selected

Patient received a nasal spray product and later developed a severe acute nasal infection with Burkholderia cepacia . Cultures of unopened containers of the nasal spray grew B. cepacia

Transmission of an infectious agent via product

Product contamination bacterial

Burkholderia cepacia infection

Acute rhinitis

Patient received a blood transfusion and developed Hepatitis C

Transfusion-transmitted infectious disease

Hepatitis C

Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via a product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via product .

3.18 Overdose, Toxicity and Poisoning

Accidental overdose terms are grouped under HLT Product administration errors and issues; other overdose terms are grouped under HLT Overdoses NEC. Toxicity and poisoning terms are grouped under HLT Poisoning and toxicity .

For the purposes of term selection and analysis of MedDRA-coded data, overdose is more than the maximum recommended dose (in quantity and/or concentration), i.e., an excessive dose (see online Concept Descriptions.)

If overdose, poisoning or toxicity is explicitly reported, select the appropriate term.

Example

Reported	LLT Selected	Comment
Patient took an overdose	Overdose	Based on this report, it is not known whether the overdose is intentional or accidental. If information is available, select the more specific LLT Accidental overdose or LLT Intentional overdose as appropriate.
A child was accidentally poisoned when she ingested a chemical cleaning product	Accidental poisoning Chemical poisoning
Patient deliberately took an overdose of analgesic pills to treat his worsening arthritis	Intentional overdose	LLT Arthritis aggravated can be selected as the indication for treatment
The dose taken was above the recommended maximum dose in the label	Overdose	Based on this report, it is not known whether the overdose is intentional or accidental. If information is available, select the more specific LLT Accidental overdose or LLT Intentional overdose as appropriate.

3.18.1 Overdose reported with clinical consequences

Select terms for overdose and for clinical consequences reported in association with an overdose.

Example

Reported

LLT Selected

Stomach upset from study drug overdose

Overdose

Stomach upset

3.18.2 Overdose reported without clinical consequences

If an overdose report specifically states that there were no clinical consequences, the preferred option is to select only a term for the overdose. Alternatively, a term for the overdose and the additional LLT No adverse effect can be selected (see Section 3.21).

Example

Reported

LLT Selected

Preferred Option

Patient received an overdose of medicine without any adverse consequences

Overdose

No adverse effect

3.19 Device-related Terms

3.19.1 Device-related event reported with clinical consequences

If available, select a term that reflects both the device-related event and the clinical consequence, if so reported.

Example

Reported	LLT Selected
Patient with a vascular implant developed an infection of the implant	Vascular implant infection
Patient noted the prosthesis caused pain	Medical device pain

If there is no single MedDRA term reflecting the device-related event and the clinical consequence, select separate terms for both.

Example

Reported

LLT Selected

Ventricular tachycardia due to malfunction of device

Device malfunction

Ventricular tachycardia

Partial denture fractured leading to tooth pain

Dental prosthesis breakage

Tooth pain

3.19.2 Device-related event reported without clinical consequences

If a device-related event is reported in the absence of clinical consequences, select the appropriate term.

Example

Reported	LLT Selected
Medical device breakage	Device breakage
My patch is leaking on my arm	Leaking patch

3.20 Drug Interactions

This term includes reactions between drugs and other drugs, food, devices and alcohol. In this document, “drug” includes biologic products.

Labelled drug interactions may be medication errors (see Section 3.15.1.3).

3.20.1 Reporter specifically states an interaction

Select an interaction term and additional term(s) for any reported medical event.

Example

Reported

LLT Selected

Torsade de pointes with suspected drug interaction

Drug interaction

Torsade de pointes

Patient drank cranberry juice which interacted with anticoagulant drug causing an INR increase

Food interaction

INR increased

3.20.2 Reporter does not specifically state an interaction

Two products may be used together, but if the reporter does not specifically state that an interaction has occurred, select terms only for the medical events reported.

Example

Reported	LLT Selected
Patient was started on an anti-seizure medication and a heart medication and developed syncope	Syncope
Patient was already on an anti-seizure medication and was started on a heart medication, and anti-seizure medication levels increased	Anticonvulsant drug level increased

3.21 No Adverse Effect and “Normal” Terms

3.21.1 No adverse effect

LLT No adverse effect can be used when absence of an AR/AE is specifically reported, despite exposure to a product (see Sections 3.15.1.2 and 3.18.2).

Some organisations may want to record LLT No adverse effect for administrative purposes (e.g., pregnancy registries, overdose and medication error reports).

3.21.2 Use of “normal” terms

Terms for normal states and outcomes can be used as needed.

Examples of Terms for “Normal” States and Outcomes

Sinus rhythm

Normal baby

Normal electrocardiogram

3.22 Unexpected Therapeutic Effect

Some organisations may want to record reports of a beneficial effect of a product apart from the reason it had been given. (Such effects are not usually considered ARs/AEs).

Example

Reported

LLT Selected

A bald patient was pleased that he grew hair while using an antihypertensive product

Unexpected beneficial therapeutic response

Hair growth increased

3.23 Modification of Effect

It is important to record modification of effect (e.g., increased, prolonged) although it is not always an AR/AE.

3.23.1 Lack of effect

The preferred option is to select only the “lack of effect” term even if consequences are also reported. However, terms may also be selected for events associated with the lack of effect.

Example

Reported	LLT Selected	Preferred Option
Patient took drug for a headache, and her headache didn't go away	Drug ineffective	ü
	Drug ineffective Headache
Antibiotic didn't work	Lack of drug effect
Patient took drug for thrombosis prophylaxis but she developed a deep vein thrombosis in her left leg	Drug ineffective	ü
	Drug ineffective Deep vein thrombosis leg

3.23.2 Do not infer lack of effect

Example

Reported	LLT Selected	Comment
AIDS patient taking anti-HIV drug died	Death	Do not assume lack of effect in this instance. Select only a term for death (see Section 3.2).

3.23.3 Increased, decreased and prolonged effect

Example

Reported	LLT Selected
Patient had increased effect from drug A	Increased drug effect
Patient had decreased effect from drug A	Drug effect decreased
Patient had prolonged effect from drug A	Drug effect prolonged

3.24 Social Circumstances

3.24.1 Use of terms in this SOC

Terms in SOC Social circumstances represent social factors and may be suitable to record social and medical history data. Such terms are not generally suitable for recording ARs/AEs; however, in certain instances, terms in SOC Social circumstances are the only available terms for recording ARs/AEs or may add valuable clinical information.

Example

Reported	LLT Selected
Patient's ability to drive was impaired	Impaired driving ability

Terms in SOC Social circumstances are not multiaxial and, unlike terms in other “disorder” SOCs in MedDRA (e.g., SOC Gastrointestinal disorders), they generally refer to a person, not to a medical condition.

Be aware of the impact that terms in SOC Social circumstances may have on data retrieval, analysis and reporting as illustrated in the table below:

Term in SOC Social circumstances (“person”)	Similar term in “Disorder” SOC (“condition”)
Alcoholic	Alcoholism
Drug abuser	Drug abuse
Drug addict	Drug addiction
Glue sniffer	Glue sniffing
Smoker	Nicotine dependence

Note that “abuse” terms not associated with drugs/substances are in this SOC, regardless of whether they refer to the person or to the condition, as illustrated in the table below:

LLT	PT
Child abuse	Child abuse
Child abuser	Child abuse
Elder abuse	Elder abuse
Elder abuser	Elder abuse

(See Section 3.24.2 concerning illegal/criminal acts.)

3.24.2 Illegal acts of crime or abuse

Terms for illegal acts of crime and abuse (excluding those related to drug/substance abuse) are in SOC Social circumstances, such as LLT Physical assault.

LLTs representing the perpetrator are linked to PTs describing the unlawful act committed. PTs representing the victim of unlawful acts generally begin with “Victim of… ”.

Example

Reported	LLT Selected	Comment
Patient's history indicates that patient is a known sexual offender	Sexual offender	Perpetrator ; LLT Sexual offender links to PT Sexual abuse in SOC Social circumstances
Patient was a childhood sexual assault victim	Childhood sexual assault victim	Victim ; LLT Childhood sexual assault victim links to PT Victim of sexual abuse in SOC Social circumstances

3.25 Medical and Social History

Example

Reported

LLT Selected

History of gastrointestinal bleed and hysterectomy

Gastrointestinal bleed

Hysterectomy

Patient is a cigarette smoker with coronary artery disease

Cigarette smoker

Coronary artery disease

3.26 Indication for Product Use

Indications can be reported as medical conditions, prophylaxis of conditions, replacement therapies, procedures (such as anaesthesia induction) and verbatim terms such as “anti-hypertension”. Terms from almost any MedDRA SOC – including SOC Investigations – may be selected to record indications.

Regulatory authorities may have specific requirements for certain aspects of term selection for indications (e.g., for indications within regulated product information). Please refer to the regulatory authority's specific guidance for such issues.

3.26.1 Medical conditions

Example

Reported	LLT Selected
Hypertension	Hypertension
Anti-hypertensive	Hypertension
Chemotherapy for breast cancer	Breast cancer
I took it for my cold symptoms	Cold symptoms

If the only information reported is the type of therapy, select the most specific term.

Example

Reported	LLT Selected
Patient received chemotherapy	Chemotherapy
Patient received antibiotics	Antibiotic therapy

It may not be clear if the reported indication is a medical condition or a desired outcome of therapy. The term selected in either case may be the same.

Example

Reported	LLT Selected	Comment
Weight loss	Weight loss	Unclear if the purpose is to induce weight loss or to treat an underweight patient
Immunosuppression	Immunosuppression	Unclear if the purpose is to induce or to treat immunosuppression

3.26.2 Complex indications

Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances.

Example

Reported	LLT Selected	Comment
Treatment of aggression in autism	Aggression	The products do not treat the underlying autism, thalassaemia, or myocardial infarction, but they do address the associated signs/symptoms (aggression, chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, LLT Thalassaemia major, or LLT Myocardial infarction based on regional regulatory requirements.
Treatment of chronic iron overload in thalassaemia major	Chronic iron overload
Prevention of atherothrombotic events in patients with myocardial infarction	Atherothrombosis prophylaxis

3.26.3 Indications with genetic markers or abnormalities

For indications that describe a genetic marker or abnormality associated with a medical condition, select a combination term that represents both concepts, if available. See also examples in Section 3.5 Combination Terms.

Example

Reported

LLT Selected

Non small cell lung cancer with K‑ras mutation

Non-small cell lung cancer

K-ras gene mutation

3.26.4 Prevention and prophylaxis

When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words “prevention” and “prophylaxis” are synonymous in the context of MedDRA).

Example

Reported	LLT Selected
Prophylaxis of arrhythmia	Arrhythmia prophylaxis
Prevention of migraine	Migraine prophylaxis

If there is no MedDRA term containing “prevention” or “prophylaxis”, choose one of the following options. The preferred option is to select a general prevention/ prophylaxis term and a term for the condition. Alternatively, select a term for the condition alone or a prevention/prophylaxis term alone.

Example

Reported	LLT Selected	Preferred Option	Comment
Prevention of hepatotoxicity	Prevention Hepatotoxicity	ü	Represents both the prevention/prophylaxis concept and the condition
	Hepatotoxicity		Represents the condition
	Prevention		Represents the prevention/prophylaxis concept

3.26.5 Procedures and diagnostic tests as indications

Select the appropriate term if the product is indicated for performing a procedure or a diagnostic test.

Example

Reported	LLT Selected
Induction of anaesthesia	Induction of anaesthesia
Contrast agent for angiogram	Angiogram
Contrast agent for coronary angiogram	Coronary angiogram

3.26.6 Supplementation and replacement therapies

Terms for supplemental and replacement therapies are in SOC Surgical and medical procedures (see Section 3.13). If the product indication is for supplementation or replacement therapy, select the closest term.

Example

Reported	LLT Selected
Testosterone replacement therapy	Androgen replacement therapy
Prenatal vitamin	Vitamin supplementation

3.26.7 Indication not reported

If clarification cannot be obtained, select LLT Drug use for unknown indication.

Example

Reported	LLT Selected
Aspirin was taken for an unknown indication	Drug use for unknown indication

3.27 Off Label Use

For the purposes of term selection and analysis of MedDRA-coded data, the concept of “off label use” relates to situations where a healthcare professional intentionally prescribes, dispenses, or recommends a product for a medical purpose not in accordance with the authorised product information (Consider also the table in Section 3.16). Off label use terms should only be selected when off label use is specifically mentioned in the reported verbatim information. For information that is suggestive of off label use but not reported, attempt to obtain clarification. If clarification cannot be obtained, do not infer that off label use occurred. When recording off label use, consider that product information and/or regulations/requirements may differ between regulatory regions.

3.27.1 Off label use when reported as an indication

If a medical condition/indication is reported along with “off label use” , the preferred option is to select terms for the medical condition/indication and off label use. Alternatively, select a term for the medical condition/indication alone. Select LLT Off label use alone only if it is the only information available.

Example

Reported

LLT Selected

Preferred Option

Hypertension; this is off label use

Off label use in unapproved indication

Hypertension

Example

Reported	LLT Selected
Used off label	Off label use

Example

Reported

LLT Selected

Comment

Drug approved for use in combination with drug A was used off label in combination with drug B

Off label use

Drug use for unapproved combination

LLT Drug use for unapproved combination provides additional information about the specific type of off label use. The term is not an off label use term or a medication error term; it is a general term that can be used in combination with other terms to capture detail about off label use, misuse, medication errors, etc.

3.27.2 Off label use when reported with an AR/AE

If an AR/AE occurs in the setting of off label use for a medical condition/indication, the preferred option is to select a term for off label use, and a term for the medical condition/indication in addition to a term for the AR/AE. Alternatively, select a term for the medical condition/indication and a term for the AR/AE.

Example

Reported

LLT Selected

Preferred Option

Patient was administered a drug off label for pulmonary hypertension and suffered a stroke

Off label use in unapproved indication

Pulmonary hypertension

Stroke

Pulmonary hypertension

Stroke

3.28 Product Quality Issues

It is important to recognise product quality issues as they may have implications for patient safety. They may be reported in the context of adverse events or as part of a product quality monitoring system.

Product quality issues are defined as abnormalities that may be introduced during the manufacturing/labelling, packaging, shipping, handling or storage of the products. They may occur with or without clinical consequences. Such concepts may pose a challenge for term selection.

Familiarity with HLGT Product quality, supply, distribution, manufacturing and quality system issues (in SOC Product issues) is essential for term selection. Under this HLGT are categories of specific product quality issues such as HLT Product packaging issues, HLT Product physical issues, HLT Manufacturing facilities and equipment issues , HLT Counterfeit, falsified and substandard products , etc. Navigating down to the appropriate LLTs from the MedDRA hierarchy is the optimal approach for term selection.

Explanations of the interpretations and uses of certain product quality issue terms (e.g., “Product coating incomplete”) are found in the online MedDRA Concept Descriptions.

3.28.1 Product quality issue reported with clinical consequences

If a product quality issue results in clinical consequences, term(s) for the product quality issue and the clinical consequences should be selected.

Example

Reported	LLT Selected	Comment
New bottle of drug tablets has unusual chemical smell that made me nauseous	Product smell abnormal Nauseous
I switched from one brand to another of my blood pressure medication, and I developed smelly breath	Product substitution issue brand to brand Smelly breath
Consumer noted that the toothpaste they had purchased caused a stinging sensation in the mouth. Subsequent investigation of the product lot number revealed that the toothpaste was a counterfeit product.	Product counterfeit Stinging mouth
Patient reported severe burning in his nose after using nasal drops that had a cloudy appearance. An investigation by the manufacturer revealed that impurities were found in the batch of nasal drops and that these had been introduced by a faulty piece of equipment.	Nasal burning Product appearance cloudy Product impurities found Manufacturing equipment issue	Specific product defects and issues with manufacturing systems may be reported subsequently as part of a root cause analysis

3.28.2 Product quality issue reported without clinical consequences

It is important to capture the occurrence of product quality issues even in the absence of clinical consequences.

Example

Reported	LLT Selected
Sterile lumbar puncture kit received in broken packaging (sterility compromised)	Product sterile packaging disrupted

3.28.3 Product quality issue vs. medication error

It is important to distinguish between a product quality issue and a medication error.

Medication errors are defined as any unintentional and preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer.

Explanations of the interpretations of product quality issue terms are found in the online Concept Descriptions.

Example

Reported	LLT Selected	Comment
Pharmacist dispensing Drug A inadvertently attached a product label for Drug B	Wrong label placed on medication during dispensing	Medication error
The drug store clerk noted that the wrong product label was attached to some bottles in a shipment of mouthwash	Product label on wrong product	Product quality issue
The mother administered an underdose of antibiotic because the lines on the dropper were illegible	Product dropper calibration unreadable Accidental underdose	Product quality issue and medication error. If underdose is reported in the context of a medication error, the more specific LLT Accidental underdose can be selected.