pharmacovigilance –an integral component of ayurvedic pharmacoepidemio

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By: visluck12 (116 month(s) ago)

sir you should make presentations to allow members otherwise nobody read our ppts. if we allow they download, should read it. because online reading not habituated in our people. please make your ppts to available to down load.

By: srinivasnaik (118 month(s) ago)

sir you should make presentations to allow members otherwise nobody read our ppts. if we allow they download, should read it. because online reading not habituated in our people. please make your ppts to available to down load. my ppts also in Ayurveda title please see them.

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150 Birth Anniversary of Founder Mahamana Pt. Madan Mohan Malaviya Jee :

150 Birth Anniversary of Founder Mahamana Pt. Madan Mohan Malaviya Jee March 28,2011 1 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Dr A B Vaidya :

Dr A B Vaidya March 28,2011 2 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Pharmacovigilance –An integral component of ayurvedic pharmacoepidemiology:

Pharmacovigilance –An integral component of ayurvedic pharmacoepidemiology Anand Chaudhary Associate Professor & Regional Coordinator Department of Rasa Shastra & Regional Centre for PVg of Ayurvedic Drugs Faculty of Ayurveda, IMS Banaras Hindu University ,Varanasi E mail- anandayubhu@gmail.com Cell – 09452074480

Content :

Content WHO Guidelines for Pharamacovigilance Significance of Pharmacovigilance Ways and means of Pharmacovigilance National Pharmacovigilance Programme March 28,2011 4 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization :

World Health Organization Article 2 To develop, establish and promote international standards with respect to Food Biologicals Pharmaceuticals Similar products March 28,2011 5 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization :

World Health Organization Article 21 Adopt regulations concerning Standards with respect to the safety ,purity and potency Biologicals , Pharmaceuticals and similar products Moving in International commerce March 28,2011 6 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization :

World Health Organization The Erice Declaration – 1997 Highest ethical ,professional and scientific standards in protecting and promoting safe use of medicine Framework of values and practice for collection ,analysis and subsequent of drug safety issues March 28,2011 7 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Point of Concern-----:

Point of Concern----- Medicines are both, powerful health care instruments and profitable commercial products . . March 28,2011 8 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Risk ---:

Risk --- No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty. March 28,2011 9 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Basic Documents:

Basic Documents March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai 10

Ideal Manuscripts :

Ideal Manuscripts March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS ,Mumbai 11

Pharmacoepidemiology:

Pharmacoepidemiology Pharmacoepidemiology is the study of the use and effects of drugs on large groups of people. Pharmacology and Epidemiology March 28,2011 12 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Enlighten Endorsement :

Enlighten Endorsement A K Raut 2011 JAIM Arthritis March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 13

Extensive Exploration :

Extensive Exploration Governance Comprehensive March 28,2011 14 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Slide 15:

Incursion of Pharmacovigilance in domain of herbal medicines March 28,2011 15 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Misconception :

Misconception Natural means safe Long use of medicine means safe Traditional medicines means safe March 28,2011 16 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Causative Causes :

Causative Causes Globalization Consumerism Explosion in free trade Self medication March 28,2011 17 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Slide 18:

Origin of Concept March 28,2011 18 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Concrete Chronology :

Concrete Chronology Documented March 28,2011 19 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Characterization :

Characterization Pharmacovigilance is the science and activities related Detection Assessment Understanding Prevention of Adverse effects or Any other possible drug related problems March 28,2011 20 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Extended Enclosure :

Extended Enclosure Herbals Traditional & complementary medicines Blood products Biologicals Medical devices Vaccines March 28,2011 21 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Aim of Pharmacovigilance :

Aim of Pharmacovigilance To help save lives and improve health By closing the huge gap between the potentials that essentials drugs have to offer and the reality Where medicines are unavailable, unaffordable, unsafe or improperly used March 28,2011 22 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Rationale Reasons :

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 March 28,2011 23 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Awareness :

Awareness Alertness Compliance March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 24

Recent Resentment :

Recent Resentment March 28,2011 25 ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai

Decisive Doctrine :

Decisive Doctrine Improve patient care and safety Medicines Medical & Paramedical interventions Improve public health and safety Medicines March 28,2011 26 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Definitive Details :

Definitive Details Assessment of medicine Benefit, harm, effectiveness and risk of medicines Promote effective communication Understanding Education Training March 28,2011 27 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Wisdomnary Vision :

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

Consequential Concerns :

Consequential Concerns Policy makers Regulatory authorities Health care practitioners Legal advisors in health care March 28,2011 29 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Beyond Belief :

Beyond Belief Wiki leaks CWG 2 G Spectrum Adarsh ISRO March 28,2011 30 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Steadfast Stakeholders :

Steadfast Stakeholders Pharmaceutical industry Editors of medical journals Consumer groups Health economist The concern layperson March 28,2011 31 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Perplexity :

Perplexity March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 32 For Pharmaceutical Companies ,the involvement in Pharmacovigilance is a complex matter.

Collaborator:

Collaborator March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 33

Compromise /Pre Mature Action ?:

Compromise /Pre Mature Action ? March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 34

Logistic Obligations :

Logistic Obligations March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 35

Adorable Attitude :

Adorable Attitude March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 36

Appropriate Approach :

Appropriate Approach Who can Report Any Health care professionals/Providers ASU Doctors Nurse Pharmacist etc March 28,2011 37 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Constituent Criteria :

Constituent Criteria What to report All suspected adverse reactions Lack of effects Resistance Drug interactions Dependence Abuse March 28,2011 38 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Adverse Drug Reaction :

Adverse Drug Reaction Noxious- An unexpected therapeutic response Nature or severity-NOT Consistent with domestic labeling Market authorization Expected from characteristic of drug March 28,2011 39 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Adverse Event :

Adverse Event Serious adverse event is any event that Fatal Life threatening Permanently/significantly disabling Requires or prolongs hospitalization Causes a congenital anomaly March 28,2011 40 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Slide 41:

March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 41 125 Patients 24 Patients experienced ADRs (19%) (59%) were avoidable

Assured Advantages :

Assured Advantages Confidentiality Submission and fate of report March 28,2011 42 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Assertive Assessment :

Assertive Assessment Physiological & Pathological pathways Medicine prescribed is the medicine received. Verify onset of suspected ADR Determine time interval March 28,2011 43 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Accurate Authenticity:

Accurate Authenticity Evaluate after discontinuation Analyze the alternative cause Use up -to -date literature Personal experience March 28,2011 44 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Documentation Dominance :

Documentation Dominance Description of problem Date of event Date of this report Relevant test Other relevant patient information Outcomes March 28,2011 45 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Drug Description :

Drug Description Name-INN & brand name Dose , frequency & route Therapy date Batch number Expiration date Reappearance Concomitant March 28,2011 46 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Points of Performance :

Points of Performance March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 47 Reporting Rate Reporting Distribution Reporting Quality Reporting Efficiency

Essential Elements :

Essential Elements March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 48 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

Move Toward :

Move Toward March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 49

Work ahead :

Work ahead Perception Process is on ------ March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 50

National Pharmacovigilance Center:

National Pharmacovigilance Center Collecting and Analyzing case reports of ADRs Distinguishing signals from background noise Making regulatory decisions based on strengthened signals Alerting prescribers, manufacturers and the public to new risks of adverse reactions March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 51

Infrastructure Itinerary :

Infrastructure Itinerary National Centre Regional Centers Peripheral Centers March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 52

Future Custodian :

Future Custodian March 28,2011 53 ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai

Substantial Salutation :

Substantial Salutation March 28,2011 54 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Keep Away From :

Keep Away From March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 55 Spontaneous reporting when Data based on Suspicion Ambiguous Doubtful Wrong Premature or Erroneous Conclusion

Best Thing:

March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 56 Best Thing Please listen to your patient!!! Pharmacovigilance

Be Vigilant -----:

Be Vigilant ----- March 28,2011 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai 57

Special Submission :

Safety Sustainability of Medicines Special Submission March 28,2011 58 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Classical Connotation :

Classical Connotation Explanation Elucidation March 28,2011 59 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Marvelous Miraculous :

Marvelous Miraculous Indian Inheritance Authoritative Agenda March 28,2011 60 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Wrapping up Pharmacovigilance of Ayurvedic Drugs is a Pragmatic Approach for its Proficient Practice.:

Wrapping up Pharmacovigilance of Ayurvedic Drugs is a Pragmatic Approach for its Proficient Practice . March 28,2011 61 ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Conclusion:

Conclusion The ultimate aim of Pharmacovigilance system is that new information be rapidly and effectively incorporated into therapeutic decision making by Physicians in benefit of Patients through Ayurvedic Pharmacoepidemiology . March 28,2011 62 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai

Take Home Message :

Wakefulness Long Live Pharmacovigilance March 28,2011 ICMR Workshop for Training in Reverse Pharmacology ,KHS ,Mumbai 63 Take Home Message

Thanks & All Good Wishes -----:

Thanks & All Good Wishes ----- March 28,2011 64 ICMR Workshop for Training in Reverse Pharmacology , KHS,Mumbai

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