Once the adverse event report or case is received to safety team, the case is triaged and reviewed and the medically most important or “primary event” is chosen. The case will be sent for data entry. The received report will be reviewed and the terms which require coding with MedDRA browser will be assessed. Below are the terms from adverse event report must be coded with MedDRA browser.
- Patient’s/parent medical history
- Lab data/investigations
- Product indication
- Events
In earlier post (https://allaboutpharmacovigilance.org/17-ii-meddra-learning-series-coding-with-meddra/) we have learnt how we use MedDRA in coding of medical history, lab data and product indication. Now we will discuss the coding of adverse events with MedDRA.
Coding of adverse events with MedDRA: Any adverse event experienced by the patient after receiving any drug/device/vaccine must be coded with MedDRA for regulatory standardisation and to support electronic submissions to regulatory authorities.
MedDRA is a medical terminology not a taxonomy and medically must be balanced, reflect actual medical practice, and have consideration for how different cultures interpret specific terms.
The MSSO puts out a detailed guidance on MedDRA Term Selection: Points to Consider Document with each new version in MedDRA page https://www.meddra.org/training-materials giving tips and suggestions on coding. It is widely used and is highly recommended.
This document provides term selection advice for industry and regulatory purposes. Objective of this document is to promote accurate and consistent term selection to facilitate a common understanding of shared data.
As per ICSR validity criteria adverse event can be:
- A specific symptom or diagnosis
- Abnormal laboratory finding
- Drug/food interaction
- Lack of efficacy or lack of expected therapeutic effect (as defined in the product label), disease aggravation, aggravation of pre existing condition.
- Medication errors
- Pregnancy
- Overdose, Abuse, dependencies, withdrawal syndrome, accidental administration
- Product quality errors, an inaccuracy in the labelling, instructions for use and/or in promotional materials. Inaccuracies include omissions and deficiencies.
- An identified medical device is associated with the event.
- The death of a patient, user, or other person
- Serious injury to a patient, user, or other person. Serious injury being a life threatening illness or injury; permanent impairment of a body function or permanent damage to a body structure; a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Current version of MedDRA (version 22.0) has below SOCs.
While selecting terms for coding we must follow MSSO guidelines and check SOC to confirm if we are selecting correct LLT for reported verbatim.
Along with the guidelines provided by MSSO we need to consider few points while selecting MedDRA terms.
- Coding of secondary AEs: A patient can have multiple events simultaneously. However, the primary goal of MedDRA is to provide the major or key terms that describe the case. It is usually the practice to code direct AEs and not secondary AEs. That is, if a drug is suspected of causing a patient to become dizzy and then fall and fracture her hip, the direct AE is the dizziness and the indirect or secondary AEs are the fall and hip fracture. As a practice many will code dizziness as event but doesn’t consider other events for coding as these were not caused by drug. Few does not consider drug causality factor for selecting event especially in spontaneous/PMS cases, they consider all the events happened after receiving drug for coding and will assess causality later.
- ABBREVIATIONS: In general, abbreviations are excluded from levels above LLT. Exceptions to this rule are: 1) when including the full term makes the phrase very long (over 100 characters); and 2) when the term has a well-established abbreviation. For example;
CNS – central nervous system
CSF – cerebrospinal fluid
ECG – electrocardiogram
NOS – not otherwise specified
- AGGRAVATION OF UNDERLYING CONDITION: We might receive events stating patient medical history aggravated or patient therapeutic indication aggravated after receiving medication. In such situations we need to select terms expressing “aggravated” or “worsened”. For example; Asthma aggravated/hypertension aggravated/worsening of pre existing condition or disease aggravated if direct coding option is not available.
- BODY SITE CONSIDERATIONS IN MedDRA: Specificity is critical in MedDRA term selection as severity might differ with the LLT we chose. For example, edema can have a very different medical meaning and treatment if it is pulmonary edema (which may be life threatening) or leg edema (which may be only bad circulation and not life threatening).
- SINGLE WORD VS. MULTIPLE WORD TERMS: Each LLT or PT represents a single concept, but the concept may be expressed in one or more words. For example, if reported event is diabetic retinopathy then we need to search for LLT which represent both the conditions if combination term is unavailable then only we need to consider splitting of verbatim and coding it as two events.
