ABPI Guidance On PV And Digital Media

Topics: Adverse drug reaction, Pharmacology, Pharmaceutical industry Pages: 14 (4498 words) Published: July 11, 2015
Guidance notes on the
management of adverse events
and product complaints from
digital media

Guidance notes on the
management of adverse events
and product complaints from
digital media
ABPI Pharmacovigilance Expert Network

Approval Status
Authors: The ABPI Pharmacovigilance Expert Network
Version: 2.0
Date: 8 April 2013
Acknowledgements: We thank the many stakeholders from industry, regulators and professional organisations who provided feedback in response to our consultation on the 2013 revision of this guidance document.

Guidance notes on the management of adverse events and product complaints from digital media

Table of contents

1.

Introduction

1

2.

Scope

1

3.

Legal framework and guidance

1

4.

Social media activities
4.1. Listening
4.2. Broadcasting
4.3. Engaging

3
3
3
3

5.

General points for consideration
5.1. Project management and oversight
5.2. Declaration of company involvement and responsibilities 5.3. Data privacy

4
4
4
5

6.

Training

5

7.

Collection and follow-up of AEs and PCs from company-sponsored sites

5

8.

Collection and follow-up of AEs and PCs from non-company-sponsored sites

6

Annex 1:

Abbreviations

7

Annex 2:

Definitions

8

Annex 3:

Revision history

10

Guidance notes on the management of adverse events and product complaints from digital media

1. Introduction
Digital media is used by individuals and organisations as a component of overall communication with patients and customers to create or raise awareness about diseases and treatments or for other strategic objectives. Pharmaceutical companies also use digital media for corporate awareness, clinical trial enrolment, and patient support programmes.

Consideration of company values, public expectation, legal and policy requirements are necessary for successful participation in the digital media environment. Additionally, Marketing Authorisation Holders (MAH) have an obligation to monitor, collect and manage product safety (or quality) information which may be generated through digital media. The following notes provide guidance on the monitoring and management of adverse events (AE) or product complaints (PC) arising from company-sponsored and non-company-sponsored digital media. The term ‘monitor’ within this document refers to monitoring for AE/PC.

These guidance notes have been developed by the ABPI Pharmacovigilance Expert Network (PEN) and shared with the Medicines and Healthcare products Regulatory Agency (MHRA). They are compiled based on current legislative requirements. However, it is the responsibility of each MAH to decide in the context of their circumstances how to apply these informal guidance notes. The ABPI and MHRA reserve the right to adopt an alternative position should they be called upon to discuss pharmacovigilance (PV) and digital media.

This document is provided by the ABPI for information purposes only and is not intended and should not be construed as regulatory or legal advice.
Companies must ensure that all their activities comply with the appropriate legislative requirements for PV and with the ABPI Code of Practice for the Pharmaceutical Industry (see Section 3 below). The Prescription Medicines Code of Practice Authority (PMCPA) which administers the Code at arm’s length from the ABPI has issued informal guidance about digital communications. Both are available from www.pmcpa.org.uk.

2. Scope
These guidance notes refer to the collection and management of AE/PC from digital media, which has been implemented for legitimate business purposes in the UK. This includes company-sponsored websites (eg www.pharmaceuticalcompany.co.uk), all company-owned social media sites used for business campaigns and use of non-company-sponsored websites.

These guidance notes are relevant for all company employees using digital media, including persons retained by way of contract with third...
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