PHARMACOVIGILANCE: CURRENT SCENARIO & FUTURE

CHALLENGES IN INDIA

JANESHWAR VERMA

PRESENTATION CONTENTS

Introduction

Why Pharmacovigilance

ADR Reporting procedure

Aim of Pharmacovigilance

Pharmacovigilance: Future challenges, Need & issues

Outcome of a successful program in Pharmacovigilance

Summery and Conclusion2

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INCREDIBLE INDIA

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The zero and decimal system were developed.

38% Doctors in America are Indian

12% Scientist in America are Indian

36% NASA employees are Indian

World’s largest democracy

Clinical Research Hub

Fourth largest exporter by volume of drugs

USFDA office in Delhi, Mumbai & ….

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PHARMACOVIGILANCE

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO 2002). 4

Pharmakon vigilare

Greek Latin

Drug to be awake or alert,

to keep watch

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WHY PHARMACOVIGILANCE?

Patients affected by preventable harm.

Top ten causes of mortality.

>10% of hospital admissions.

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HISTORY OF PHARMACOVIGILANCE Ja

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BRIEF HISTORY OF PHARMACOVIGILANCE

The Thalidomide Disaster

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BRIEF HISTORY OF PHARMACOVIGILANCEJa

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BRIEF HISTORY OF PHARMACOVIGILANCEJa

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INDIA ?

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BRIEF HISTORY OF PHARMACOVIGILANCE

Pharmacovigilance in India

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PHARMACOVIGILANCE HIGHLIGHTS:GROWTH OF THE WHO GLOBAL ICSR DATABASE

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individual case safety reports

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WHAT TO REPORT?

All suspected reactions

Lack of effect

Resistance

Interaction

Dependence and abuse

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WHICH TO REPORT?

Allopathic medicines including OTC

Traditional Medicines

Biologicals like vaccines and sera

Herbals

Blood products

Medical devices

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WHERE TO REPORT ?

Patient Health

Professional

Regional Centre

Manufacturer

Hospital

National Centre

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MAJOR HEALTH PROFESSIONALS

Physicians

Dentists

Pharmacists

Nurses

Other health workers

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WHEN IS AN ADR SERIOUS?

Death / life-threatening (real risk of dying)

Hospitalization (initial or prolonged)

Disability (significant, persistent or permanent)

Congenital anomaly

Requires intervention to prevent

Permanent impairment or damage

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Reporting form

1. The patient

2. Adverse event

3. Suspected drug(s)

4. All other drugs used

5. Risk factors

6. Name and address of reporter

Reporting forms will be distributed.

Telephone, fax and email used to reporting ADR’s. 21

REPORTING OF ADVERSE DRUG REACTIONJa

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AIM OF PHARMACOVIGILANCE

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Improve patient care and safety

Improve public health and safety

Early detection of unknown safety problems

Identification of risk factors

Quantifying risks

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AIMS OF PHARMACOVIGILANCE

Janeshwar Verma ITS, Ghaziabad

Assessment of benefit, harm & effectiveness

Promote understanding, education in PV.

Encouraging safe, rational, and effective use

Preventing patients from being affected unnecessarily

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AIMS OF PHARMACOVIGILANCE

Janeshwar Verma ITS, Ghaziabad

PARTNERS IN PHARMACOVIGILANCE

Partners in the practice of drug safety monitoring.

Government

Industry

Hospitals and academia

Medical and pharmaceutical associations

Health professionals

Patients

Consumers

Media

WHO 25

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INDIA TODAY

PV is still in its infancy in INDIA

Major advancement are in western countries

More clinical research conducted in India

Immense need to understand the importance of PV

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PHARMACOVIGILANCE,CHALLENGES, NEEDS & ISSUES

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Population that is predominantly rural.

Use of traditional medicines.

Poor reporting.

Lake of physician and consumer awareness.

Inadequate post marketing surveillance.

Surfeit no. of licensed drug manufactures (>6,000)

Surfeit no. of branded formulations (>60,000).

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PHARMACOVIGILANCECHALLENGES, NEEDS AND ISSUES

Need to move toward more active Pharmacovigilance PSURs (Periodic Safety Update Reports)

Post marketing studies

Risk Management plans (periodicity driven by risk)

Improved communication

Need to Strengthen Safety Reporting Requirements for: Medical Devices,

Food Supplements and

Herbal products. 29

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PHARMACOVIGILANCECHALLENGES, NEEDS AND ISSUES

Each country should:

Establish a PV system and collect information

Training of HCPs and Health Authorities.

Promote Product Safety Awareness.

Encourage all HCPs to report suspected ADRs.

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PHARMACOVIGILANCECHALLENGES, NEEDS AND ISSUES

OUTCOME OF A SUCCESSFUL PROGRAM IN

PHARMACOVIGILANCE

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OUTCOME OF A SUCCESSFUL PROGRAM IN PHARMACOVIGILANCE

Assessment of benefit, harm, effectiveness & risk.

Improve patient care and safety.

Improve public health and safety.

Promote understanding, education & training in PV.

Effective communication to the public.

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SUMMARY & CONCLUSION

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To minimize the harm, medicine should have good:

Efficacy: Evaluated from clinical trials.Quality: Established standards by GMP.Safety : By toxicology, clinical trials.

In all, Pharmacovigilance will promote:

Systematic and rational use of medicines

Boost confidence for safety.34

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SUMMARY & CONCLUSIONS

KEY MESSAGES

The NPvP launched to improve the current state

Its basic purpose is to analyze ADR data

Healthcare team actively participate in the program

They should start reporting AE

Help to ensure that children’s safety

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THANK YOU

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‘People who are vigilant do not die; people who are negligent are as if dead’.

Shakyamuni Buddha

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