MedDRA Labelling – European MedDRA User Group Labelling – European MedDRA User Group (MUG) –...

download MedDRA Labelling – European MedDRA User Group Labelling – European MedDRA User Group (MUG) – Vienna March 2014 . Use of MedDRA in Summary of ... ‘Interstitial pneumonia’

of 25

  • date post

    06-Feb-2018
  • Category

    Documents

  • view

    222
  • download

    1

Embed Size (px)

Transcript of MedDRA Labelling – European MedDRA User Group Labelling – European MedDRA User Group (MUG) –...

  • NDA Group 2013

    MedDRA & Labelling European MedDRA User

    Group (MUG) Vienna March 2014

    Use of MedDRA in Summary of Product Characteristics (SPCs)

    Morell David

    Principal Consultant- Pharmacovigilance and Drug Safety

    NDA Regulatory Science

  • NDA Group 2013 NDA Group 2013

    Disclaimer

    o The views and opinions expressed in the following PowerPoint slides are those of the individual presenter.

    o These PowerPoint slides are the intellectual property of the individual presenter

    and are protected under the copyright laws of the United States of America and other countries.

    2

  • Outline o Background o MedDRA Coding vs Labelling o Basis for Using MedDRA in Labelling o Needs of Different Stakeholders o Summary

    3

  • MedDRA and International Guidelines What We Already Know!

    o MedDRA developed for use by regulators and biopharmaceutical industry for: o Clinical studies o Spontaneous adverse event/reaction reports o Regulatory submissions o Regulated product information

    o MedDRA intended to be used throughout the entire regulatory process, from

    pre-marketing through post-marketing, for data entry, retrieval, evaluation, and presentation

    o Used for coding adverse events/adverse reactions, signs and symptoms, procedures, investigations, indications, and medical and social histories

    o Coding Guidelines based on MedDRA Term Selection: Points to Consider (ICH Endorsed Guide for MedDRA Users)

    4

  • How A Typical Safety Surveillance Process might look?

    Non-clinical Clinical Ops/ Stats Reg Affairs PVRM CQA

    Signal Detection

    Safety Review Team (SRT)

    Executive Labelling

    Committee

    CCDS PBRER/ DSUR RTD/RMP IB

    Ad Hoc Communication

    Non-clinical studies and Literature

    Clinical trials Observational Studies

    PASS Literature

    HA Requests ICSR

    Epidemiology

    Quality Complaints

    Population data Epi Studies

    Local Label

    Gov

    erna

    nce

    Eval

    uatio

    n An

    alys

    is

    Dat

    a Ac

    quis

    ition

    O

    utpu

    ts

    5

  • How should we use MedDRA in Regulated Product Information?

    o Best practices guidelines on the use of MedDRA for labelling was published by MSSO in 2005

    o EU SPC Guidelines 2009

    o MSSO proposed 3 tiers of product labelling:

    o Labelling for national/regional healthcare professionals (HCPs) o Labelling for patients/consumers o Labelling in the form of a Company Core Data Sheet (CCDS)

    6

  • Labelling for Patients/Consumers

    7

    Labelling for national/regional healthcare professionals (HCPs)

  • Labelling for national/regional healthcare professionals (HCPs)

    o Labelling should serve to communicate information on the benefits and risks as well as advice on the effective and safe use of a product to HCPs and other end users

    o National/regional HCP labelling is intended to be used by

    to determine expectedness of adverse drug reactions (in terms of nature, severity, specificity, or outcome) for purposes of expedited reporting to local regulatory authorities

    8

  • Labelling for Patients/Consumers

    9

    Labelling for Patients/Consumers

  • Labelling for patients/Consumers

    o Using MedDRA terms in the patient/consumer labelling could be challenging as most MedDRA terms (PT level and above) are generally not readily interpretable by patients/consumers without some degree of medical or healthcare training

    o Although patient information is based upon and must be

    consistent with the information provided in the HCP labelling, this labelling must use language that is easily understood by non-professionals, rather than medical terminology

    10

  • Labelling for Patients/Consumers

    11

    Labelling for Company Core Data Sheet (CCDS)

  • Labelling for Company Core Data Sheet (CCDS) 1

    o CCDS used by manufacturers as internal reference labelling for local affiliates

    o The CCDS generally contains a defined set of data and advice that

    the company plan to reflect in national or regional labelling worldwide

    o This reference safety information is commonly designated as

    Company Core Safety Information (CCSI) o The CCSI information is typically designed to reflect the companys

    view of the essential safety information that will assist in the selection and use of the medicine by healthcare professionals.

    o The CCSI can also apply to products that are in clinical development!

    12

  • Labelling for Company Core Data Sheet (CCDS) 2

    o The CCDS is usually used as a global reference document for the determination of listedness for periodic safety reporting (i.e., as reference labelling for Periodic Safety Update Reports [PSURs])

    o In the CCDS - MedDRA should be used in narrative and tabular

    presentations of information

    o The PT level of MedDRA should be used in the adverse reactions section of the CCDS, but supplemented with HLTs, HLGTs and/or SMQs or similar groupings to represent particular conditions, if needed

    o In the CCDS it might be possible to supplement PTs with a list of

    corresponding LLTs to assist with judging listedness and to facilitate automated expectedness determination

    o However, if used, this list of LLTs should not be a substitute for medical

    judgement.

    13

  • Labelling for Patients/Consumers

    14

    EU Summary of Product Characteristics (SPC) Guideline 2009

  • MedDRA & Labelling - SPC Guideline 2009 (Rev 2)

    o EU Labelling Guidelines based on the SPC Guideline which was first put out for consultation in 2005

    o Guideline Introduced in EU 2009 o Guideline included in The Rules Governing Medicinal Products

    in the European Union - Volume 2C Notice to Applicants and effective from 01 May 2010

    o Consistent medical terminology should be used

    throughout the SmPC, In particular: o section 4.3 Contraindications o section 4.4 Special Warnings and Precautions o Section 4.8 Undesirable effects

    15

  • SPC guideline 2009 Basic Principles (1) o Table of ADRs in Section 4.8 Undesirable effects by MedDRA SOC o SOCs should be presented in International SOC order o Events should be arranged by frequency within each SOC, with most

    frequent reactions listed first o Pragmatic approach to term location to make ADRs clinically appropriate to

    the reader o Adverse reactions descriptions should be based on the most suitable

    representation within the MedDRA terminology o This will usually be at the Preferred Term (PT) level, although there may be

    instances where the use of Lowest Level Terms (LLTs) or exceptionally group terms, such as High Level Terms may be appropriate

    16

  • SOC Order MedDRA Alphabetical SOC Order MedDRA International SOC Order SOC Blood and lymphatic system disorders SOC Infections and infestations SOC Cardiac disorders SOC Neoplasms benign, malignant and unspecified (incl

    cysts and polyps) SOC Congenital, familial and genetic disorders SOC Blood and lymphatic system disorders SOC Ear and labyrinth disorders SOC Immune system disorders SOC Endocrine disorders SOC Endocrine disorders SOC Eye disorders SOC Metabolism and nutrition disorders SOC Gastrointestinal disorders SOC Psychiatric disorders SOC General disorders and administration site conditions SOC Nervous system disorders SOC Hepatobiliary disorders SOC Eye disorders SOC Immune system disorders SOC Ear and labyrinth disorders SOC Infections and infestations SOC Cardiac disorders SOC Injury, poisoning and procedural complications SOC Vascular disorders SOC Investigations SOC Respiratory, thoracic and mediastinal disorders SOC Metabolism and nutrition disorders SOC Gastrointestinal disorders SOC Musculoskeletal and connective tissue disorders SOC Hepatobiliary disorders SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps)

    SOC Skin and subcutaneous tissue disorders

    SOC Nervous system disorders SOC Musculoskeletal and connective tissue disorders SOC Pregnancy, puerperium and perinatal conditions SOC Renal and urinary disorders SOC Psychiatric disorder SOC Pregnancy, puerperium and perinatal conditions SOC Renal and urinary disorders SOC Reproductive system and breast disorders SOC Reproductive system and breast disorders SOC Congenital, familial and genetic disorders SOC Respiratory, thoracic and mediastinal disorders SOC General disorders and administration site

    conditions SOC Skin and subcutaneous tissue disorders SOC Investigations SOC Social circumstances SOC Injury, poisoning and procedural complications SOC Surgical and medical procedures SOC Surgical and medical procedures SOC Vascular disorders SOC Social circumstances

    17

  • SPC guideline 2009 Basic principles (2)

    o Adverse reactions should be assigned to the most relevant SOC related to the target organ. For example, if the PT Liver function test abnormal, Hepatitis and Hepatic encephalopathy are to be included in an SPC, it would be acceptable to handle them as follows:

    18

    MedDRA Coding EU SPC Guidelines

    MedDRA PT Primary SOC Proposed SOC Location

    Liver function test abnormal Investigations Hepatobiliary disorders

    Hepatitis Hepatobiliary disorders Hepatobiliary disorders

    Hepatic encephalopathy Nervous system disorders Hepatobiliary disorders

  • SPC guideline 2009 Basic principles (3)

    o It is acceptable to adapt the names of the MedDRA group terms if