Minutes of Meeting(MOM)
MOM of “3rd Interactive Session on Participating of Marketing Authorization Holders in PvPI: A way forward”
MOM of “4th Interactive Session on Participating of Marketing Authorization Holders(MAHs) in PvPI”

Partners Roles and Responsibilities in Ensuring Vaccines Safety
Partners Roles and Responsibilities in Ensuring Vaccines Safety

Communications in Pharmacovigilance

Introduction

Effective communication channels are the key to a successful PvPI. Communicating safety information to patients and healthcare professionals is a public health responsibility and is essential for achieving the objectives of pharmacovigilance in terms of promoting the rational, safe and effective use of medicine, preventing harm from adverse reactions and contributing to the protection of public health. Communication in PvPI improves patient care, understanding, promotes transparency and accountability.

The following chart depicts the movement of information between the key stakeholders and ensures the continuous bidirectional nature of the transfer of data, information, and knowledge.

All the communications with WHO-UMC are managed by NCC. All the issues associated with drug safety are reported to CDSCO which further takes appropriate regulatory decision and action on the basis of recommendation of NCC. The objective of communication in PvPI aims to provide evidence based information on the safe and effective use of medicine and regulatory status of medicines in India as well as globally. For this PvPI is using different modes of communications as follow:

Press Communication

It includes press release and press briefings which are primarily intended for journalists. The Secretary-Cum-Scientific Director, IPC is the only designated authority to correspond with media, related to all activities and issues of PvPI.

Website: A website is a key tool for the stakeholders including patients and health professionals. NCC and CSDCO shall ensure that all important safety information should be published on the websites under their control.

Newsletter: To communicate the findings and regulatory status of medicine in India as well as globally to the stakeholders, IPC-NCC publishes newsletter i.e. “PvPI Newsletter” three issues in a year. This newsletter is for everyone concerned with the issues of pharmacovigilance which provides practical information and advice on drug safety and information about emerging safety issues. The newsletter can also be downloaded from IPC website www.ipc.gov.in under Pharmacovigilance Program of India.

Basic knowledge and skills

Interaction and the communications loop

A complete, effective communication is a message which

• has been tailored to its audiences
• has been sent out and received
• has had the desired effect (change or action of some kind)
• has generated feedback of some kind about the process
• has contributed to the refinement of future messages

Simple transmission of a message in one direction (usually outwards from the centre) is not a communication; it is essentially a random and irresponsible gesture with low probability of success. Communication is an interactive, reciprocal, continuous process.

In the cycle of effective communications, these are some of the questions which need asking and answering (most of these discussed below):

• Who exactly are my audiences and what are their needs?
• What are the best methods for reaching these audiences?
• How can I check that the message has been received?
• How can I find out what effect the message had?
• How can I establish some kind of useful interaction with my audiences?
• How can I learn to communicate more effectively next time?

Empathy

This quality is at the heart of all good communications. Empathy is the ability to grasp, understand and feel what it is like to be someone else:

• their thoughts and priorities
• their worries and problems
• their view of the world

If we have a message for anybody at all (a child, an elderly person, doctors or pharmacists, for example), then we must know who they are, their circumstances when they receive our message, the ways in which they are likely to perceive and react to our message. They must feel that we understand them; that our communication recognises who they are.

Empathy is essentially an act of mature emotional and imaginative reaching out. It comes from listening and observation, and, of course, from research (see below), but also from a disposition of humility: my urgent needs to communicate are secondary to, and must be determined by, my understanding of the nature of my audience and what they need.

Audiences

Every audience has different characteristics and needs. Communications must be tailored, shaped, focussed for a particular audience. It is obvious that a message for paediatricians is going to be very different from the message for the parents of sick children. But within the target group of parents, for example, there will also be many different groups with different needs; amongst them, parents who are:

• blind or partially sighted
• illiterate or semi-literate
• foreign language speakers
• literate and educated
• poorly motivated or lacking trust

Obviously printed materials are not much use for blind or partially sighted people; language which is suitable for educated people may mean nothing to those with poor literacy skills; a country’s mother tongue may be useless for substantial groups of immigrants. So, one message, in one form, delivered by one method, is likely to miss very large numbers of people.

You might think that an audience category like ‘doctor’ or ‘nurse’ would be simpler to deal with, but even here there will be large differences in the characteristics of individuals. Some of these include:

• Level of education and literacy
• Seniority and experience
• Speciality and interests
• Motivation and morale
• Working conditions
• Organisational commitment to (for example) patient safety

So, a highly motivated health professional, committed to advancing knowledge and career, will respond very differently from someone who is tired and demoralised and struggling against great pressure. They require different approaches, or approaches which implicitly acknowledge and respond to the differences.

Media Communications

Events

Photo Gallary
Indian Pharmacopoeia Commission (IPC) signs MOU with National Accreditation Board of Hospitals and Healthcare Providers (NABH)
WHO-NRA Assessment 2017
Launch of IPC, NCC-PvPI as WHO Collaborating Centre for Pharmacovigilance on October 30, 2017 at IPC Ghaziabad