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Code of Conduct

Key Research Stages – During Fieldwork

M. Adverse Event Reporting



Overview

Based upon the Guideline on good pharmacovigilance practices (GVP), Module VI – Management and reporting of adverse reactions to medicinal products, European Medicines Agency 22 June 2012 EMA/873138/2011

Introduction

12.1

EphMRA’s Adverse Event Reporting Guidelines detail the scope of market researchers’ adverse event reporting responsibilities and the requirements of the process.


12.2

Details of suspected adverse reactions that meet the qualifying and minimum reporting criteria should be forwarded by the contracted market research agency and their sub-contractors to the nominated contact within the market authorisation holder that commissioned the market research. This information is assessed by the pharmacovigilance department and if appropriate it will be reported to the regulators as an individual case safety report and/or within a periodic safety update report.


Basis of Guidelines

12.3
EphMRA’s Adverse Event Reporting Guidelines are based upon legal requirements:
  • Detailed in Directive 2001/83/EC and Regulation (EC) No 726/2004, as regards the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the European Union
  • Interpreted within the European Medicines Agency’s Guidelines on good pharmacovigilance practices, particularly volume VI Management and reporting of adverse reactions to medicinal products

Within the European Union, MAHs are legally obliged to report suspected adverse reactions and those adverse events that they consider to be signals.  Market research (MR) studies commissioned by pharmaceutical companies (MAHs) but carried out on their behalf on a sub-contract basis by independent MR agencies are subject to the EMAs adverse reaction and event reporting guidelines detailed in module VI and module VII.  However if an organisation is conducting an MR programme independently, without being commissioned, financed or influenced by a MAH, the requirements provided in EU pharmacovigilance legislation do not apply.    It is the MAH’s responsibility to set up contracts with the market research supplier detailing how they would like adverse event reporting to be implemented during the course of the study and the training required.

The term ‘adverse event’ is used as an umbrella term within this section and refers to adverse events, potential adverse reactions, product complaints and specific reporting situations such as drug interactions.



EphMRA Members’ Responsibilities

12.4

EphMRA members should understand and adhere to the EphMRA Adverse Event Reporting (AER) Guidelines and ensure others involved in market research (MR) abide by the guidelines too – such as suppliers and sub contractors as well as colleagues in marketing, sales and national/local market researchers.


12.5

The AER Guidelines apply irrespective of which functional area or organisation/department within the marketing authorisation holder (MAH)/pharmaceutical company initiated the work i.e. whether the work is commissioned by the department responsible for market research, marketing or another function.


Responsibility to MR subjects

12.6

All MR subjects whether healthcare professionals or not should be informed at recruitment of the requirement for MAHs to report adverse events that arise during MR.


Impact of Disclosure Requirements

12.7

EFPIA disclosure requirements and the US Sunshine Act do not generally require agencies to identify to client companies the names of the healthcare professionals who report adverse events.  

Glossary & Terminology
AE     Adverse Event
AER  Adverse Event Reporting
AR     Adverse Reaction
EU     European Union
HCP   Healthcare Professional
ICSR  Individual Case Safety Report
MAH  Marketing Authorisation Holder
MR     Market Research
PSUR  Periodic Safety Update Report
PV       Pharmacovigilence

EMA Guidelines:

"All applicable legal requirements detailed in this Module are usually identifiable by the modal verb "shall”.   Guidance for the implementation of legal requirements is provided using the modal verb "should”.”
 


 


Important Background Information

12.8

The European Medicines Agency categorises adverse event reports as solicited or unsolicited depending upon their source. With regard to market research sources solicited reports include AEs from MR studies except when social media/digital listening is used, AEs arising from digital listening are classified by the EMA as unsolicited reports.


12.9

Adverse events may be collected within Individual Case Safety Reports or as Signals within Periodic Safety Update Reports collated by the marketing authorisation holders’ pharmacovigilance department and forwarded to the regulators.


12.10

Solicited reports are "derived from organised data collection systems, which include clinical trials, non-interventional studies, registries, post-approval named patient use programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, compassionate use or name patient use, or information gathering on efficacy or patient compliance." The European Medicines Agency (EMA) state that "safety reports originating from market research (MR) programmes should be considered as solicited reports. A MR programme refers to the systematic collection, recording and analysis by a marketing authorisation holder of data and findings about its medicinal products, relevant for marketing and business development.


12.11

Unsolicited reports include spontaneous reports, literature reports, other sources e.g. lay press and those from the internet or digital media. The EMA states that:

  • "MAHs should regularly screen internet or digital media under their management or responsibility, for potential reports of suspected ARs. In this aspect, digital media is considered to be company sponsored if it is owned, paid for and/or controlled by the MAH
  • If a MAH becomes aware of a report of suspected AR described in any non-company sponsored digital medium, the report should be assessed to determine whether it qualifies for reporting”

Consequently AEs arising from the use of social media to gather market research information i.e. digital listening will be unsolicited reports whilst those cited during any other form of online market research, face to face, telephone or postal market research will be solicited reports. This does not make any difference to market research activities.


12.12

Individual Case Safety Report (ICSR) refer "to the format and content for the reporting of one or several suspected adverse reactions in relation to a medicinal product that occur in a single patient at a specific point of time. A valid ICSR should include at least one identifiable reporter, one single identifiable patient, at least one suspect adverse reaction and at least one suspect medicinal product.”


12.13

Signals are "information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.”


12.14

ICSRs are forwarded directly to regulators and ICSRs and signals are incorporated into periodic safety update reports these are the "format and content for providing an evaluation of the risk-benefit balance of a medicinal product for submission by the marketing authorisation holder at defined time points during the post-authorisation phase.”

Source: Module VI – Management and reporting of adverse reactions to medicinal products, European Medicines Agency 22 June 2012 EMA/873138/2011


EphMRA Adverse Event Reporting Guidelines 2017

You can find the guidelines here


EphMRA Adverse Event Reporting Form

Click here to view the Adverse Event Report Form
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