INDIAN PHARMACOVIGILANCE SYSTEM “PRESENT STATUS AND FUTURE CHALLENGES”

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

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

HISTORICAL MILESTONES……..contd.

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 medicinesBlood products & vaccinesMedical devicesCosmeticsCounterfeit and substandard medicine Increasing self-medication practicesIllegal sale of medicines & drugs of abuse over

the internetMedication 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.

Dr. A. K. Agarwal (RML, New Delhi)Dr. Anoop Mishra (AIIMS, New Delhi)

General Medicine

Dr. T. D. Dogra, (AIIMS, New Delhi) Forensic Medicine

Dr. Ranjit Roy Choudhary, NII, New Delhi

Dr. C. Adithan, Prof. Pharmacology JIPMER, Pondicherry

Member, Pharmacology

Dr. Nilima Kshirsagar, SGS Medical College (Mumbai)

SGC Medical College, Mumbai, Zonal Centre Coordinator

Dr. S. K. Gupta, Former, Head of the Department of Pharmacology, AIIMS, New Delhi

AIIMS, New Delhi, Zonal Centre Coordinator

D. G., ICMR, New Delhi ICMR

Director General Health Services Chairperson

NATIONAL PHARMACOVIGILANCE ADVISORY COMMITEE

NATIONAL PHARMACOVIGILANCE ADVISORY COMMITTEE (cont..)

Dr. Urmila Thatte, Head of the Department of Pharmacology, B. L. Nair Medical College Hospital, Mumbai

Member, Phytotherapy

Dr. Pramil Tiwari (NIPER, Mohali) Member, Drug Information

Dr. Kusum Verma Member Secretary, (AIIMS Ethics Committee, New Delhi)

Member, Pathology

Dr. M. D. Gupte (ICMR Institute of Epidemiology, Chennai)

Member, Epidemiology

Dr. Y. K. Gupta, Prof & Head Dept. of Pharmacology AIIMS

Member, Toxicology

Mr. Brijesh Regal, WHO Consultant, New Delhi

Member, Pharmacy

Dr. S. D. Seth, Chair-in Clinical Pharmacology (ICMR, New Delhi)

Clinical Pharmacology

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

Ministry of HealthRegulation and

Legislation

HealthcareProfessionals

Academia

PharmaceuticalProducts and

Companies

Drug users:Patients

Organizations

WHOHarmonization and

Transparency of policyUppsala Monitoring Centre

Essential drug list

Pharmao-vigilance

NGOsHealth Action International

International consumerOrganizations

Information media

A PHARMACOVIGILANCE ARENA

UMC WHO

CDSCO

ZONAL INTENSIVE MONITORING

SPECIFIC PROJECTS

REGIONAL ZONAL CENTRESAnalyzed/Assessed

PERIPHERAL CENTRESADRs/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

GlobalizationBroader safety concernsPublic health versus pharmaceutical industry

economic growthMonitoring of established productsDeveloping and emerging countriesImproving 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