Transcript Introduction to Clinical Research

INDIAN PHARMACOVIGILANCE SYSTEM
“PRESENT STATUS AND FUTURE
CHALLENGES”
PHARMACOVIGILANCE
Pharmacovigilance is the science and activities
relating to the detection, assessment
understanding and prevention of adverse effect or
any other possible drug-related problems.
MAGNITUDE OF THE PROBLEM
In the U.S. alone 2.2 million hospitalized
patients have serious ADRs each year, of
which 106,000 have a fatal outcome
Cost of drug related morbidity and mortality
exceeds $177.4 billion annually
30% - 50% ADRs are preventable
HISTORICAL MILESTONES
1937- Over 100 people died from renal
failure due to an elixir of sulfanilamide
dissolved in diethylene glycol
1938- FDA made preclinical toxicity studies
and pre-marketing clinical trials mandatory
1950s- Aplastic anaemia shown to be due to
chloramphenicol
1960- Hospital based drug monitoring
programme started by FDA
HISTORICAL MILESTONES……..contd.
1961- Thalidomide disaster
1968- WHO established its International Drug
Monitoring Programme
1970s- Subacute myelo-optic neuropathy linked
to clioquinol
1980s & 1990s large number of drugs with
serious adverse effects
GOALS OF PHARMACOVIGILANCE
Rational and safe use of medicinal drugs
Assessment and communication of risks and
benefits of drugs on the market
Educating and informing the patients
OBJECTIVES OF PHARMACOVIGILANCE
Early detection of hitherto unknown adverse
reactions and interactions especially for the
newly marketed drugs
Detection of increase in frequency of (known)
adverse reactions
Identification of risk factors and possible
mechanisms underlying adverse reactions
Benefit-risk analysis
PLAYERS IN PHARMACOVIGILANCE
 WHO
 Uppsala Monitoring Centre
 National Pharmacovigilance Centres
 Hospitals and Academia
 Healthcare professionals
 Patients
 Media and consumer advocacy groups
WHO PROGRAMME OF INTERNATIOAL
DRUG MONITORING
 Identification & analysis of new adverse reaction
signal from the case report information submitted
to the National Centres.
Provision of the WHO database as reference
source for signal . Web-based search facilities
Information exchange between WHO & National
Centres.
 Guidelines and books publications of Periodical
newsletters in the pharmacovigilance and risk
management area
WHO PROGRAMME OF INTERNATIOAL
DRUG MONITORING
 Tools for management of Clinical information
 Training and consultancy support
 Software for case report management
 Meeting for representatives of National Centers
 Methodological Research
UPPSALA MONITORING CENTRE
OVERVIEW – AREAS OF WORK OF
THE UPPSALA MONITORING CENTRE
 Receipt, analysis & recording of worldwide adverse
event data
 Maintenance & screening of international database
(currently over 3.7 million records)
 Publication of previously unknown adverse events
in SIGNAL.
 Editing, updating & publishing the WHO Drug
Dictionary
OVERVIEW – AREAS OF WORK OF
THE UPPSALA MONITORING CENTRE
 Maintaining & publishing the Adverse Reaction
Terminology (WHO-ART)
 Carrying out special searches of the database by
request
 Publishing a range of special reports
 Assistance to potential members of the
Programme in developing their Pharmacovigilance
system
 Running training courses in Pharmacovigilance
COUNTRIES PARTICIPATING IN THE WHO
INTERNATIOAL DRUG MOINTORING
PROGRAMME
 Official Member Countries (dark Blue)
 81 Countries Members
 17 Countries Associate
PHARMACOVIGILANCE ….IS IT NEEDED
IN EVERY COUNTRY?
There are differences between countries in the
occurrence of adverse drug reactions due to
differences in:
drug production
drug distribution and use
genetics, diet, traditions of the people
use of non-orthodox drugs (e.g. traditional
medicines)
PHARMACOVIGILANCE - THE WIDENING
HORIZONS
Traditional and complementary medicines
Blood products & vaccines
Medical devices
Cosmetics
Counterfeit and substandard medicine
Increasing self-medication practices
Illegal sale of medicines & drugs of abuse over
the internet
Medication errors
INDIAN AWARENESS
 After the clioquinol incidence.
 Withdrawal of clioquinol
 Establishment of DCGI centers
 Program still remained dormant – till1990’s
National Pharmacovigilance center 1998
NPVP:CDSCO
NATIONAL PHARMACOVIGILANCE CENTRE
(WHO-UMC)
1998
BROAD OBJECTIVES OF PROGRAMME
 To foster the culture of AE notification and
reporting
 To establish a viable and broad-based ADR
monitoring program in India.
 Specific objectives of the Programme
 To create an ADR database for the Indian
Population
……contd.
BROAD OBJECTIVES OF PROGRAMME
 To create awareness of ADR monitoring
among people
 To ensure optimum safety of drug products in
Indian market
 To create infrastructure for ongoing regulatory
review of PSURs
NATIONAL PHARMACOVIGILANCE
POLICY & MILESTONES
The National Pharmacovigilance Programme will have
the following milestones:
 Short-term objectives: To foster a culture of
notification
 Medium-term objectives: To engage several healthcare
professionals and NGOs in the drug monitoring and
information dissemination processes.
 Long-term objectives: To achieve such operational
efficiencies that would make Indian National
Pharmacovigilance Programme a benchmark for global
drug monitoring endeavours.
NATIONAL PHARMACOVIGILANCE
ADVISORY COMMITEE
Chairperson
Director General Health Services
ICMR
D. G., ICMR, New Delhi
AIIMS, New Delhi, Zonal Centre
Coordinator
Dr. S. K. Gupta, Former, Head of the
Department of Pharmacology, AIIMS,
New Delhi
SGC Medical College, Mumbai, Zonal
Centre Coordinator
Dr. Nilima Kshirsagar, SGS Medical
College (Mumbai)
Member, Pharmacology
Dr. Ranjit Roy Choudhary, NII, New
Delhi
Dr. C. Adithan, Prof. Pharmacology
JIPMER, Pondicherry
Forensic Medicine
Dr. T. D. Dogra, (AIIMS, New Delhi)
General Medicine
Dr. A. K. Agarwal (RML, New Delhi)Dr.
Anoop Mishra (AIIMS, New Delhi)
NATIONAL PHARMACOVIGILANCE
ADVISORY COMMITTEE (cont..)
Clinical Pharmacology
Dr. S. D. Seth, Chair-in Clinical
Pharmacology (ICMR, New Delhi)
Member, Pharmacy
Mr. Brijesh Regal, WHO Consultant, New
Delhi
Member, Toxicology
Dr. Y. K. Gupta, Prof & Head Dept. of
Pharmacology AIIMS
Member, Epidemiology
Dr. M. D. Gupte (ICMR Institute of
Epidemiology, Chennai)
Member, Pathology
Dr. Kusum Verma Member Secretary,
(AIIMS Ethics Committee, New Delhi)
Member, Drug Information
Dr. Pramil Tiwari (NIPER, Mohali)
Member, Phytotherapy
Dr. Urmila Thatte, Head of the
Department of Pharmacology, B. L. Nair
Medical College Hospital, Mumbai
HIERARCHIAL STRUCTURE OF
PROPOSED CENTRES
PERIPHERAL PHARMACOVIGILANCE
CENTRE – ACTIVITIES
 Primary contact ADR data collection center
 Small Medical centers nursing homes (Clinics,
Private hospitals, Pharmacies)
 Primary Pharamcovigilance centers
 Identified & coordinated by RPCs/ZPCs
 At least one in each state & UT and some other
leading medical College
REGIONAL PHARMACOVIGILANCE
CENTRE – ACTIVITIES
( Secondary Pharmacovigilance Centre)
 Relatively larger facilities attached with medical
college
 Will act as secondary level centers
 First contact for ADE data collection
 Identified and coordinated by Zonal centres
(Five regional centre)
ZONAL PHARMACOVIGILANCE
CENTRES
( TERTIARY PHARMACOVIGILANCE CENTRE)
 Large health care facility attached with medical
college in metro cities
 Identified by CDSCO
 3rd level levels
 Also act as Ist ADE data collection centre
 AIIMS (North & East zone)
 KEM Mumbai (South and West)
CENTRAL DRUG CONTROL STANDARD
ORGANISATION (CDSCO)
 To establish and manage database of ADRs
 To make regulatory decisions regarding
marketing authorization and safety of drugs
 Possible regulatory measures in coordination
with NPAC
A PHARMACOVIGILANCE ARENA
Ministry of Health
Regulation and
Legislation
WHO
Harmonization and
Transparency of policy
Uppsala Monitoring Centre
Essential drug list
Drug users:
Patients
Organizations
Pharmaovigilance
NGOs
Health Action International
International consumer
Organizations
Information media
Pharmaceutical
Products and
Companies
Healthcare
Professionals
Academia
UMC WHO
CDSCO
ZONAL
INTENSIVE MONITORING
SPECIFIC PROJECTS
REGIONAL ZONAL CENTRES
Analyzed/Assessed
PERIPHERAL CENTRES
ADRs/ADEs
DRUG WITHDRAWALS THE
ENVIRONMENT NOW
 New medicines reaching market faster than ever
before
 New science – new ADRs
 Public expectations higher than ever- 60% people
assume safety guaranteed
COMMUNICATIONS ARE CRITICAL

Clear, comprehensible, targeted messages
meeting the needs of audience
 Health professionals
 The public
 Other regulatory authorities and WHO
DRUG WITHDRWALS- THE CHALLENGES
 Robust evidence
 Timely decision making
 Effective communications
 Demonstrable protection of public health
DRUG WITHDRAWALS –THE EVIDENCE
 Strengthen spontaneous reporting and signal
detection
 Use epidemiological databases to strengthen
signals- and also to detect?
 Look for evidence of safety as well as harm
DRUG WIDHRWALS - OPPORTUNITIES
 New data sharing technology
 New EU legislative power
 Risk management plans
 Better communications- including electronic
 Public education on risk
PHARMACOVIGILANCE……………..THE
CHALLENGES AHEAD
Globalization
Broader safety concerns
Public health versus pharmaceutical industry
economic growth
Monitoring of established products
Developing and emerging countries
Improving communication amongst various
partners in pharmacovigilance.
MESSAGE
 To achieve the ultimate goal of
pharmacovigilance i.e. rational and safe use
of drugs
 Every person on earth needs to be involved
 Let’s strive to make the world a safer place
to live where benefit-risk ratio of drug
therapy is in favor of the human race
Its time to join hands &
Share a common goal to deliver safe drugs to our
patients