communication in pharmacovigilance pharmacovigilance for B pharmacy and pharm D

1. COMMUNICATION IN
PHARMACOVIGILANCE
S. Nashrah Nasreen
B-pharmacy
21441R0084

2. CONTENTS
 Introduction
 Effective Communication in
Pharmacovigilance
 Communication in Drug
safety Crisis Management
 Communication with
regulatory agencies,
Business partners,

3. INTRODUCTION:
Communication in pharmacovigilance refers to
the exchange of information and knowledge
between different stakeholders involved in the
monitoring, assessment, and prevention of
adverse effects or other drug-related problems.
Effective communication is essential for ensuring
the safety of drugs and vaccines and improving
public health.

4. EFFECTIVE COMMUNICATION IN
PHARMACOVIGILANCE
The ability to communicate clearly, both orally and in writing, inside
and outside the formal meeting format.
It includes :
• Meeting between FDA and sponsors
• Written Correspondence from FDA
• Submission from sponsors
• Acknowledging Receipt of communities
• Email between FDA and sponsors
• General telephone calls between FDA and sponsors
• Faxes between FDA and sponsors

5. Meeting between FDA and Sponsors:
Sponsors can request meetings with FDA at any time during developments to resolve
questions and issues.
• Face to face meetings
• Teleconferences
• Written response (WRO)
Written correspondence from FDA:
FDA project manager will use established letter templates to ensure consistency and
accuracy in regulatory communications.
Submissions from sponsors:
 FDA regulations general principles and content format requirement for INDs.
Submissions can increase the efficacy of FDA review.
 FDA encourages sponsors to identify issues in their submission by describing them fully
and soliciting feedback on specific areas of concern where further progression in drug
development depends largely on receiving FDA feedback.
Acknowledging Receipt of communications:
FDA project managers will send written acknowledgement of receipt that have timeline,
they receive from sponsors by telephone calls, emails, and other submissions within 3
days.

6. Email between FDA and sponsors:
Sponsors should establish a secure email with FDA to allow for informal communication,
include commercial confidential information.
General telephone calls between FDA and sponsors:
General questions are suitable for informal telephone communication between sponsors
and FDA project managers
Faxes between FDA and sponsors:
It is not a substitute for formal submissions, it is used when secure information is not
beenestablished between sponsors and FDA.

7. COMMUNICATION IN DRUG
SAFETY CRISIS
MANAGEMENT:
• Expert responses to public queries
• Drug safety communication
• Safety labelling changes
• Risk communication research

8. Expert responses to public queries:
 As a healthcare professionals respond to public queries around the world providing
expert guidance and respond to the queries about human drug product
 More than 65000 requests receive annually
 Queries receive via phone, electronic mails, and letter from array of stakeholder
 Social media and online tools for DDERs public interface in using multiple digital
platform and tools to provide drug safety outreach and education.
 Facebook, twitter, podcast.
 Pharmacovigilance in CDERs/FDA introduction to FDAs medwatch adverse reporting
programme.
Drug safety communication:
 Patients, caregivers, healthcare professionals, public should be updated on drug safety
communication.
 This manages from emerging risks and cautions about medical errors
 This contain actionable recommendations from patients about the drugs and make
them more informed decisions and prevent drug related harm.

9. Safety labelling changes:
 When a drug is approved for safety marketing, not every safety concern or risk potential
can be identified.
 Post market safety is essential to learn more about the effects of a medicine when use by
a large no.of people for long duration.
 If new safety concerns emerge after a medicine is used in a real-world CDER may require
‘safety labelling change’ or [SLC]
 It includes contraindications, warnings, and precautions.
Risk communication research:
 OCOMM houses a number of ongoing research studies that will allow better
understanding of CDER audiences knowledge, perceptions, needs, desires, and
behaviours related to a variety of drug safety information.
 This research efforts also provide the public , including people with limited health literacy
or who face disparities in accessing health services, opportunities, for input on the
effectiveness of CDER drug safety information.

10. Communication with regulatory
agencies, business partners, healthcare
facilities and media.
• Pharmacovigilance in regulation of medicines
• Pharmacovigilance in practice
• Pharmacovigilance in clinical practice
• Pharmacovigilance in disease control public
health programmes

11. Pharmacovigilance in regulation of medicines:
 They provide the foundation for a national ethos of medicine safety and for public
confidence in medicines.
 The regulatory authorities need to go further than approval of new medicines to
encompass a wider range of issues relating to the safety medicines, namely
 Clinical trails
 Safety of complimentary and traditional medicines, vaccines, and biological medicines.
 Development of communication between all parties which have an interest in medicine
safety, ensuring that they are able to function efficiently and ethically at time of crisis.
Pharmacovigilance in practice:
 Cerivastin was first approved as a lipid-regulating agent in 1997.by 2000 a total 549 cases
of rhabdomyolysis associated with cerivastatin reported to WHO centre and also
international drug monitoring centre Uppsala, Sweden.
 Then prescribing information changed to include a contraindication for the combined
use of cerivastatin and gemfibrozil another lipid-regulating medicine.
 February 2001 in Australia a warning issued to alert prescribers to the possibility of
rhabdomyolysis occurring with all statins.
 A regulatory action taken and manufactures withdrew from the market .

12. Pharmacovigilance in clinical practice:
 Safety monitoring of medicine in common use should be an integral part of clinical
practice.
 The degree in which clinicians are informed about the principles of pharmacovigilance
and practice according to them has a large impact on the quality of health care.
 Education and training of health professionals in medicine safety exchange of
information between national and pharmacovigilance centres, the coordination of such
exchange, and the linking of clinical exchange effective patient care.
Pharmacovigilance in disease control public health
programmes:
 The monitoring of medicine safety in countries where there is no regulatory or safety
monitoring system in place, or in remote areas with little or no health care surveillance
or by infrastructure, has been identified.
 The problems are especially apparent in situation that involve the use of medicines in
specific communities, for example for the treatment of tropical diseases such as
malaria, leishmaniosis and schistosomiasis, and for the treatment of HIV/AIDS and
tuberculosis.
 Several diseases control initiatives involving the administration of medication to large
communities are being implemented within the same population with little knowledge
or how this medicines could interact with each other.
 Pharmacovigilance should be a priority for every country with a public health disease

13. Pharmacovigilance in disease control public health
programmes:
 The monitoring of medicine safety in countries where there is no regulatory or safety
monitoring system in place, or in remote areas with little or no health care
surveillance or by infrastructure, has been identified.
 The problems are especially apparent in situation that involve the use of medicines in
specific communities, for example for the treatment of tropical diseases such as
malaria, leishmaniosis and schistosomiasis, and for the treatment of HIV/AIDS and
tuberculosis.
 Several diseases control initiatives involving the administration of medication to large
communities are being implemented within the same population with little knowledge
or how this medicines could interact with each other.
 Pharmacovigilance should be a priority for every country with a public health disease
control programme.