KHS ICMR RP 28 March 2011 03 Version

8/4/2019 KHS ICMR RP 28 March 2011 03 Version

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150 Birth Anniversary of

Founder Mahamana Pt. MadanMohan Malaviya Jee

March 28,2011 1ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai


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PHARMACOVIGILANCE AN INTEGRAL

COMPONENT OF AYURVEDICPHARMACOEPIDEMIOLOGY

Anand Chaudhary

Associate Professor & Regional CoordinatorDepartment of Rasa Shastra &

Regional Centre for PVg ofAyurvedic Drugs

Faculty ofAyurveda, IMSBanaras Hindu University ,Varanasi

E mail- [email protected]

Cell 09452074480


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World Health Organization

Article 2

To develop, establish and promote international standardswith respect to

Food Biologicals

Pharmaceuticals

Similar products



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Article 21

Adopt regulations concerning

y Standards with respect to the safety ,purity and potency

y Biologicals, Pharmaceuticals and similar products

Moving in International commerce



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The Erice Declaration 1997

Highest ethical ,professional and scientific standards inprotecting and promoting safe use of medicine

Framework of values and practice for collection ,analysis

and subsequent of drug safety issues



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Risk ---

No medicinal product is entirely or

absolutely safe for all people, in all places,

at all times. We must always live withsome measure of uncertainty.



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Basic Documents

March 28,2011ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

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Ideal Manuscripts


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Pharmacoepidemiology

Pharmacoepidemiology is the study of the

use and effects of drugs on large groups of

people.

Pharmacology and Epidemiology



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nlighten Endorsement

A K Raut

2011

JAIM Arthritis

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Extensive Exploration

Governance Comprehensive



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Incursion of

Pharmacovigilance indomain of herbal medicines



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Causative Causes

Globalization

Consumerism

Explosion in free trade

Self medication



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Origin of Concept



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Concrete Chronology

Documented



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Extended Enclosure

Herbals

Traditional & complementary medicines

Blood products

Biologicals

Medical devices

Vaccines



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Aim of Pharmacovigilance

To help save lives and improve health

By closing the huge gap between the potentials thatessentials drugs have to offer and the reality

Where medicines are unavailable, unaffordable, unsafe

or improperly used



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Rationale Reasons

Potentials of conflict of interest

Unethical patient recruitment practices

Inadequacy of informed consent

Lack of capacity to monitor clinical trials

Poor reporting and management of adverse events



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Awareness

Alertness Compliance


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Recent Resentment

March 28,201125

ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai


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Decisive Doctrine

Improve patient care and safety

Medicines

Medical & Paramedical interventions

Improve public health and safety

Medicines



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Definitive Details

Assessment of medicine

Benefit, harm, effectiveness andrisk of medicines

Promote effective communication

Understanding

Education

Training



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Consequential Concerns

Policy makers

Regulatory authorities

Health care practitioners

Legal advisors in health care



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Beyond Belief

Wiki leaks

CWG

2 G Spectrum

Adarsh

ISRO



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Steadfast Stakeholders

Pharmaceutical industry

Editors of medical journals

Consumer groups

Health economist

The concern layperson



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Perplexity

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For Pharmaceutical Companies ,the involvement in

Pharmacovigilance is a complex matter.


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Collaborator


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Compromise /Pre Mature Action ?


Regulators &Companies

Journalists&Patients

Educators &Prescribers


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Logistic Obligations


Integrationof PVg

DrugRegulation

DrugInformation

Rationalizationof Drug Use


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Adorable Attitude



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Appropriate Approach

Who can Report

Any Health care professionals/ProvidersASU Doctors

Nurse

Pharmacist etc



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Adverse Drug Reaction

y Noxious-An unexpected therapeutic

response

y Nature or severity-NOTy Consistent with domestic labeling

y Market authorization

y Expected from characteristic of drug



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Adverse Event

Serious adverse event is any event that

Fatal

Life threatening

Permanently/significantly disabling

Requires or prolongs hospitalization

Causes a congenital anomaly



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Assured Advantages

Confidentiality

Submission and fate of report



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Assertive Assessment

y Physiological & Pathological pathways

y Medicine prescribed is the medicine received.

y Verify onset of suspectedADR

y

Determine time interval



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Accurate Authenticity

Evaluate after discontinuation

Analyze the alternative cause

Use up -to -date literature

Personal experience



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Documentation Dominance

Description of problem

Date of event

Date of this report

Relevant test

Other relevant patient information

Outcomes



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Drug Description

Name-INN & brand name

Dose , frequency & route

Therapy date

Batch number

Expiration date

Reappearance

Concomitant



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Points of Performance


Reporting Rate

Reporting Distribution

Reporting Quality Reporting Efficiency


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Essential Elements


The primary role of spontaneous reporting is signal generation

Number of reporting physician

Quantity of information

Quality Evidence

CRITICAL MINIMUM NUMBER OF CASE

REPORTS FOR A SIGNAL


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Move Toward


Signal Testing

SignalSuspicion S Signalstrengthening


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Work ahead

Perception Process is on ------



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National Pharmacovigilance

Centery Collecting andAnalyzing case reports ofADRs

y Distinguishing signals from background noise

y Making regulatory decisions based on strengthenedsignals

yAlerting prescribers, manufacturers and the public tonew risks of adverse reactions



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Infrastructure Itinerary

National Centre

Regional Centers

Peripheral Centers



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Future Custodian

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Substantial Salutation



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Best Thing

xPlease listen to your patient!!!

Pharmacovigilance


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Be Vigilant -----



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Safety Sustainability of Medicines

Special Submission



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Classical Connotation

Explanation Elucidation



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Marvelous Miraculous

Indian Inheritance Authoritative Agenda



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Wrapping up

Pharmacovigilance of Ayurvedic Drugs is a

Pragmatic Approach for its Proficient Practice.



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Conclusion

The ultimate aim of Pharmacovigilance system is

that new information be rapidly and effectively

incorporated into therapeutic decision makingby Physicians in benefit of Patients through

Ayurvedic Pharmacoepidemiology .



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Wakefulness Long Live Pharmacovigilance

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Take Home Message


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Thanks & All Good Wishes ---

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