ESTABLISHING PHARMACOVIGILANCE

PROGRAMME
INTRODUCTION

The word pharmacovigilance is derived from the Greek word pharmacon

meaning ‘drug’ and the Latin word vigilare meaning ‘to keep awake or alert, to
keep watch.’

Pharmacovigilance (PV) system monitors the safe and effective use of drugs
and other pharmaceutical medications. According to the definition of World
Health Organization (WHO), pharmacovigilance is a “science and activities
relating to the detection, assessment, understanding and prevention of adverse
effects or any other possible drug-related problems”
FUNCTIONS OF A PERFECT PV NETWORK:

 Identifying signals of medicine safety for unknown medicines to medicines

which are given in combination.
 Assessing the risks out of an adverse effect and taking steps to manage those.
 Identifying quality problems in medicines which may result in ADRs.
 Ensuring effective public communication for proper using of medicines.
 Incorporating outcomes of the health researches in a public health
programmes and in national medicine policies.
 Developing and maintaining drug utilization information.
 Identifying issues regarding uncontrolled prescribing of medication and
their distribution and also supporting to eradicate them.
ESTABLISHING PV IN A HOSPITAL

 Pharmacovigilance in India was initiated way back in 1986 with a formal

adverse drug reaction (ADR) monitoring system, under supervision of the drug
controller of India. India joined the World Health Organization (WHO)
Programme for International Drug Monitoring in 1998, but was not successful.
 Later, the National Programme of Pharmacovigilance was launched in 2005, and
was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010.
 India then joined the WHO Adverse Drug Reaction (ADR) monitoring program,
based in Uppsala, Sweden. Three centers were assigned the task of ADR
monitoring of marketed medicines - All India Institute of Medical Sciences
(AIIMS) New Delhi, King Edward Memorial (KEM) Hospital Mumbai, JLN
Hospital Aligarh Muslim University.
MINIMUM REQUIREMENTS FOR A PHARMACOVIGILANCE
NETWORK

The main goal of PV is to provide assurance for a safe use of medications. Thereby, in other
words, it can be assumed that the main concentration of a PV network is to ensure ‘patients’
safety’. To ensure this there needs certain requirements for its operations:
 A well-organized drug safety management team: this is to increase the communication
among the PV network. To assure an organized structure and smooth function, meetings
among the PV practitioners, managers, technical agencies and donors should to be held
time to time.
 A national database: This gives the provisions for collating and managing ADR reports.
 A national PV advisory committee.
 Clear strategy should be specified for the communication in both routine and crises event
communication.
 Funding must be available to run different grounds of a network.
PLANNING THE BASICS

 Communication process
 Data acquisition
 Dissemination
 Establishment
 Internal education
 Database
 Promotion
 Networking
ESTABLISHMENT PV IN INDUSTRY
 Pharmacovigilance has been defined as the process of identifying and responding to
drug safety issues and has grown considerably as a discipline over the past 10 to 15
years.
 The aims of pharmacovigilance within the industry are essentially the same as those
ofregulatory agencies; that is to protect patients from unnecessary harm by
identifyingpreviously unrecognised drug hazards, clucidating pre-disposing factors,
refuting falsesafety signals and quantifying risk in relation to benefit.
 Although the perspectives of companies and the regulatory agencies may be different
they now work more and more closely together and share information. However,
central pharmacovigilance units in major pharmaceutical companies in many
instances are far better resourced and have much greater 'in-house' expertise on the
safety of their particular products.
 The identification and analysis of the safety characteristics of medicines falls into
twodistinct stages.
1. Before before marketing, the main methodology is experimental with clinical trials
comparing the new treatment to placebo or existing alternative treatments.
2. After introduction of a new medicine into general use, the main safety methodology
is observational, i.e. uses data from observation of patients treated in clinical practice
rather than from experimental situations.
 In general, the experimental data are of much higher quality than the observational,
with better control of confounding factors. The challenge in pharmacovigilance,
therefore, is to analyse and draw well founded conclusions from observational data
collected after marketing.
 In the final stages of the drug development, the drug will be exposed on to a
group of volunteers and/or patients in order to obtain the approval required to
launch the new drugto the market.
 Clinical trials are divided into four phases
 Being the three first stages the pre-marketing clinical trials and the last one the
post marketing monitoring.
PRE-MARKETING CLINICAL TRIALS

 Safety monitoring in clinical trials involves collecting adverse events, laboratory

investigations and details of the clinical examination of patients. Pharmacovigilance
staff may be involved to varying degrees in all phases of clinical trials, including the
planning, execution, data analysis and reporting of safety information.
POST-MARKETING CLINICAL TRIAL

 The general process is basically that utilised by regulatory authorities and other
parties working on drug safety matters.
 The first step is signal generation, i.e. processes that can identify possible new
ADRs. There may then be a period of signal strengthening
 second step such signals are subjected to hypothesis testing, i.e. processes that
determine whether the signal does indeed indicate a new ADR, or whether it is false.
 Whereas the signal generation process is, in principle, relatively simple if the right
systems are in place, the hypothesis testing process is challenging and often time
consuming and may require a variety of different approaches.
CONTRACT RESEARCH ORGANISATION (CRO)
 A Contract Research Organization (CRO) is a service organization which provides
support to the pharmaceutical industry.
 It offers various pharmaceutical research that is essential for conducting clinical trials
in the present boom, when various complications are involved in the drugdiscovery
process.
 Various companies are involved in his type of development many examples are the
like Lupin, Quintil, Cipla, Zydus, Cadeila.They are also conduct these type of trails
with the collaboration of many multinational companies and these Indian companies
are making space in foreign.
 According to ICH-GCP contract research organization define as an organization
contracted by the sponsor to perform one or more of a sponsor's trial related function
and duties.
WHAT DOES A CONTRACT RESEARCH ORGANIZATION DO?

CROS are able to provide a wide range of clinical research services to medicalsponsors, including, but not
limited to:
 Project and Data Management
 Clinical Study Oversight and Execution
 Research Education and Compliance
 Medicine and Disease Coding
 Validation Programming
 Product Development Planning and Commercialization
 Safety and Efficacy Reporting
 Quality Analysis Biostatistical Review etc.
TYPES OF CONTRACT RESEARCH ORGANIZATIONS

Different CROS can offer varying services, but they are most commonly grouped by
where their contribution falls on the sponsor's research timeline, along with the CRO's
primary function:
 Discovery
 Preclinical
 Clinical
 Laboratory Services
THREE CRITICAL STEPS TO ENSURE SUCCESS WITH A CRO

In order to ensure successful outsourcing, the sponsor should focus on three

criticalsteps:
 Determine accurate study specifications
 Select the right CRO
 Manage the study
CRO ROLES AND RESPONSIBILITY

CRO roles and responsibilities are...

 Evaluate feasibility
 Provide adequate well managed staff
 Conduct study activities
 Manage processes
 Bring problems and proposed solutionsto the sponsor's attention
 Ensure that the solutions are cost-effective
NATIONAL PHARMACOVIGILANCE PROGRAMME (NPP)

 To improve the actual state of working of Pharmacovigilance activities, the central drug
regulatory agency. The Central Drugs Standard Control Organization (CDSCO) launched
the NPP (National Pharmacovigilance Programme) in November 2004 under the aegis of
Union Ministry of Health and Family Welfare.
 The purpose of this program is to collate, analyze and archives adverse drug reaction data
for making regulatory decisions regarding drugs marketed in India.
 This program has 3 tier structures-Peripheral, regional and zonal Pharmacovigilance
centers.
 However, the programme did not meet the expectations and in 2009, it was
suspended as the support from World Bank was discontinued.
 The NPP was renamed the Pharmacovigilance Programme of India (PvPI), which
started functioning 14 July 2010, with the All India Institute of Medical Sciences
(AllMS), New Delhi In order to monitor ADRs all over India, the programme had 22
ADR monitoring centers (AMCs),including AllMS, New Delhi.
 The NCC was later shifted from All MS to Indian Pharmacopoeia Commission
(IPC), Ghaziabad, on 15 April 2011.
 The PVPI collates the information received in the form of Individual Case Safety
Reports (ICSRs) from the AMCs, HCPs, pharmacists and other non- HCPs.
OBJECTIVE OF PROGRAMME
 To create a nationwide system for patient safety reporting.
 To identify and analyze new signals from the reported cases.
 To analyze the benefit-risk balance of marketed medications.
 To generate evidence-based information on the safety of medicines.
 To support regulatory agencies in the decision-making process on the use of medications.
 To communicate safety information on the use of medicines to various stakeholder to minimize
therisk.
 To emerge as a national center of excellence for pharmacovigilance activities.
 To collaborate with other national centers for the exchange of information and data
management.
 To provide training and consultancy support to other national pharmacovigilance centersglobe.
 To promote rational use of medicines.
E 2 E PHARMACOVIGILANCE PLANNING (PVP)

 This guideline is intended to aid in planning pharmacovigilance activities,

especially in preparation for the early postmarketing period of a new drug (in
this guideline, the term "drug" denotes chemical entities, biotechnology-derived
products, and vaccines). The main focus of this guideline is on a Safety
Specification and Pharmacovigilance Plan that might be submitted at the time of
licence application. The guideline can be used by sponsors to develop a stand-
alone document for regions that prefer this approach or to provide guidance on
incorporation of elements of the Safety Specification and Pharmacovigilance
Plan into the Common Technical Document (CTD).
The purpose of this guideline is to propose a structure for a Pharmacovigilance Plan,
and a Safety Specification that summarises the identified and potential risks of the
product to be addressed in the Plan. The guideline is divided into the following
sections:
 Safety Specification
 Pharmacovigilance Plan
 Pharmacovigilance Methods.
REFERENCES

 Gupta Y. K. (2010). Pharmacovigilance Programme for India.

 Kalaiselvan V.. Sharma S. S GBingh G. N. (2014b). Adverse reactions to contrast
media: an analysis of spontaneous reports in the database of the
PharmacovigilanceProgramme of India.
 Ma Q. Lu A. Y. (2011). Pharmacogenetics, pharmacogenomics, and
individualized medicine Pharmacol.
 WHO-Essential Medicines Health Products (2002). Pharmacovigilance.
 ICH Guideline E2D: Post-approval Safety Data Management Definitions and
Standards for Expedited Reporting, 3.1.1 Spontaneous Reports.
Thank youu