INDIAN PHARMACOVIGILANCE SYSTEM

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INDIAN PHARMACOVIGILANCE SYSTEM PRESENT STATUS
AND FUTURE CHALLENGES
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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.
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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

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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

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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

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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

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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

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PLAYERS IN PHARMACOVIGILANCE

• WHO
• Uppsala Monitoring Centre
• National Pharmacovigilance Centres
• Hospitals and Academia
• Healthcare professionals
• Patients
• Media and consumer advocacy groups

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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

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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

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UPPSALA MONITORING CENTRE
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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

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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

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COUNTRIES PARTICIPATING IN THE WHO INTERNATIOAL
DRUG MOINTORING PROGRAMME

• Official Member Countries (dark Blue)
• 81 Countries Members
• 17 Countries Associate

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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)

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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

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INDIAN AWARENESS

• After the clioquinol incidence.
• Withdrawal of clioquinol
• Establishment of DCGI centers
• Program still remained dormant till1990s
• National Pharmacovigilance center 1998
• NPVPCDSCO

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NATIONAL PHARMACOVIGILANCE CENTRE(WHO-UMC)1998
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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.

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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

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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.

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NATIONAL PHARMACOVIGILANCE ADVISORY COMMITEE
Director General Health Services
Chairperson
D. G., ICMR, New Delhi
ICMR
Dr. S. K. Gupta, Former, Head of the Department
of Pharmacology, AIIMS, New Delhi
AIIMS, New Delhi, Zonal Centre Coordinator
Dr. Nilima Kshirsagar, SGS Medical College
(Mumbai)
SGC Medical College, Mumbai, Zonal Centre
Coordinator
Dr. Ranjit Roy Choudhary, NII, New Delhi Dr. C.
Adithan, Prof. Pharmacology JIPMER, Pondicherry
Member, Pharmacology
Dr. T. D. Dogra, (AIIMS, New Delhi)
Forensic Medicine
Dr. A. K. Agarwal (RML, New Delhi)Dr. Anoop
Mishra (AIIMS, New Delhi)
General Medicine
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NATIONAL PHARMACOVIGILANCE ADVISORY COMMITTEE
(cont..)
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HIERARCHIAL STRUCTURE OF PROPOSED CENTRES
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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

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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)

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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)

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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

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A PHARMACOVIGILANCE ARENA
Ministry of Health
Regulation and Legislation
Drug users Patients Organizations
Pharmao-vigilance
WHO Harmonization and Transparency of
policy Uppsala Monitoring Centre Essential drug
list
NGOs Health Action International International
consumer Organizations
Information media
Healthcare Professionals Academia
Pharmaceutical Products and Companies
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UMC WHO
CDSCO

ZONAL INTENSIVE MONITORING SPECIFIC PROJECTS
REGIONAL ZONAL CENTRES Analyzed/Assessed
PERIPHERAL CENTRES ADRs/ADEs
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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

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COMMUNICATIONS ARE CRITICAL

• Clear, comprehensible, targeted messages meeting
  the needs of audience
• Health professionals
• The public
• Other regulatory authorities and WHO

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DRUG WITHDRWALS- THE CHALLENGES

• Robust evidence
• Timely decision making
• Effective communications
• Demonstrable protection of public health

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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

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DRUG WIDHRWALS - OPPORTUNITIES

• New data sharing technology
• New EU legislative power
• Risk management plans
• Better communications- including electronic
• Public education on risk

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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.

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MESSAGE

• To achieve the ultimate goal of pharmacovigilance
  i.e. rational and safe use of drugs
• Every person on earth needs to be involved
• Lets strive to make the world a safer place to
  live where benefit-risk ratio of drug therapy is
  in favor of the human race

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Its time to join hands Share a common goal to
deliver safe drugs to our patients