CHALLENGE OF HERBAL MEDICINE IN THE MANAGEMENT OF

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PHARMACOVIGILANCE IN ASU CLASSICS :

PHARMACOVIGILANCE IN ASU CLASSICS Dr. Srinivas Naik Medical officer N.R.S. Govt . Ayurvedic College V ijayawada

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WHAT IS AYURVEDA ? Hita Ayu Ayurved Ahita Ayu Sukha Ayu Dukha Ayu Dharma Artha Kama Moksha Sharira Indriya Satva Atma Swasthasya swastha Rakshanam Aturasya Vikara Prasamana

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Diagnosis is first followed by Medication

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What is vigilance? To keep watch to be examined to do pariksha

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What is the perfect medicine?

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What is the perfect medicine? Cont. A drug not known is likened to poison, weapon, fire and thunderbolt while the one known, to be nector. . . . . . . . . . . . . . . . . . . . . . ..

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What is the perfect medicine? Cont. A drug known in respect of its name, form and properties or event if known, improperly administered, lead to bad consequences.

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What is the perfect medicine? Cont. An acute poison can become an excellent drug if it is properly administered even a drug, if not properly administered, become an acute poison.

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Sources of Medicine Jangam (Animal source) Oudbhida (Plant source) Parthiba (Earth source) Honey, milk, ghee etc. All Plant part All minerals eg. Gold, Zink, Copper etc.

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Types of dravya Dosha Pprasaman Dhatu Pradusana Swastha Vrittam

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Dhatu pradushana = abheshaja Badhana Sanubadhana

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Reason of ADR of Ayurvedic Medicine Effect / side effect Ausadha bala Prakriti, Sarira, Desha, kala, matra, prabhava, ritu, vyadhi, grihita, nihita, upaskrita Vyadhi bala Teekshna, Madhyam, Mridu Atura bala Dasavidha pariksha

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Reason of ADR of Ayurvedic Medicine Cont.

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Reason of ADR of Ayurvedic Medicine Cont. All drugs and diet which dislodge the various dosas but do not expel them out of the body are to be regarded as unwholesome.

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Desha virduha Kala virudha Dosha virudha Abastha virudha Upachara virudha Samskara virudha Parihara virudha Samyoga virudha Matra virudha Virudha ahara / dravya Sampat virudha Agni virudha Satmya virudha Virya virudha Karma virudha Kostha virudha Hrid virudha

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Mechanism of Drugs Action Pharmacodynamics Pharmacokinetics Rasa Guna Virya Vipaka Prabhaba

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Drug administration Concentration in rasa dhatu Concentration at the site of action Effect Effect of medicine in body (Ayurvedic concept) Pharmaco kinetics Pharmacodynamics

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Pharmacodynamics (Ayurvedic concept)

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Result of ADR according to Ayurveda Drug drug interaction or drug diet interaction – 1. Blockage of the action site 2. Excessive mala production 3. Production is something new 4. Breaking of the drug each other

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Result of ADR according to Ayurveda Virudha ahara/dravyas effect (Ch. Su. 26/102-103) Cont. Vandhya (infertility) Andhata (blindness) Visarpa (urticaria) Visphota (blister) Unmada (insanities) Udakadara (Ascitis) Bhagandara (fistula) Mucha (fainting) Mada (intoxication) Adhaman (tympanitis) Galagraha (sposmatic obstruction of throat) Pandu (Anaemia) Ama Visa Kilasa kustha (skin disease) Grahani Sotha (oedema) Amlapitta (acidity) Jwara (Fever) Peenasa (coryza) Santana dosha (fetal disease) Mrityu (death)

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Pill (Vati) Formulation Medicated oil (Taila ghrita) Powder (Churna) Decoction (kwath) Paste (Kalka) Juice (swaras) Alcoholic (Asava/arista) Extract (Avaleha)

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Difficulties of ADR reporting in Ayurveda Lack of knowledge about the medicine Lack of knowledge about the preparation Lack of knowledge about the ingrediance Physician thought to establish as a side effect less medicine Physician thought about loss of their popularity No standardization and quality control Common belief is no side effect

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Is it ADR? Case No. 1 A patient in three years back admitted in GAC Hospital as a case of tranverse myelitis which was treated by Ayurvedic medicine and patient completely recover. He continue the medicine for 1 year.

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after 2 years patient expired in chronic renal failure Is it ADR? Cont. Is it due to Ayurvedic medicine ?

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Is it ADR? Cont. Case No. 2 A female patient admitted in our hospital as a case of severe appetite loss, nausea and vomiting. Patient party treated the patient as a case of jaundice and treated under some traditional healers. After examination she was not suffered from jaundice and investigation shows increase SGPT level . Is it due to traditional healers medicine ?

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Is it ADR? Cont. Case No. 3 A female patient diagnosed as a case of RA and was taking Sanjivani Vati for 3 month. After that she has lost 50% of hair and developed skin eruption Is it due to Ayurvedic medicine ?

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Responsibility of the trainee participants of this CME Convey the knowledge to others The vigilance and report to nearer PPC or RPC Encourage everybody for reporting

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Stay always in close observation

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Author takes the help of lecture presented by Dr. Hitesh Vyas, Sr. Lecturer, Samhita, IPGT & RA in ROTP of Pharmacovigilance was held from 17 th to 22 nd November 2008. Acknowledgement

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Thanks