A critical review on concerns of Drug safety in Ayurveda

Transcription

1 A critical review on concerns of Drug safety in Ayurveda Raghavendra Naik, PhD Scholar R N Acharya, Professor & Head Department of Dravyaguna, IPGT&RA, Jamnagar

2 What is ADR.. A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'. WHO, (1972) औषध हह अनभ ज न त न म र ऩ ग ण स त र भ व ज न त च वऩ द र क त अनर थ य ऩऩद यत Cha su 1/125 Intended drug response, the possible ways and mechanism of event has already been documented in various texts of Ayurveda.

3 Assessment of ADR- Need in Ayurveda अततमथत रमकथऱ अल ऩ त ल यव य रभथववतम असम यक स स क त ज र ण व यथऩद य त तद षधम ध र वम 3

4 Drug interaction Mineral drugs & ADR Possible Reasons for ADR Overdose Panchakarma & ADR Unwholesome drugs Irrational use 4

5 Effect could be synergistic, decreased action, antagonistic action or increase in the bioavailability Drug Interaction न क र यथ सङ कर हहत अ स स २३/३२ Drug Apathya in Parada ब हत बबल क ष म णड ग र क र ल लकम म ष मस र ननष ऩ क लत थ सष ऩ नतलम क रर च गर व ष टस त म त क ष ण ष ण च श त र ज त र र स ११/१२५ Disease Drug Diet त ष ण र म खश ष च हन रतम गलग रह न ज र तथ ण गभ णर न प रशरर त ध नन Haritaki Excercise अम ल त क ष णमज ण ञ च व र र श रमम तऩम qé±ç र ष त र ज त सम र क ग ण थ ऩ रस क प र Apathya in Guggulu

6 क ष ठऩ ण मर क च छ र रक तवऩत त ण ज र द ह ननद घशरद न ऩ स त जतम र द कम प र 6

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8 2. Overdose According to ICH, All noxious and un intended responses to a medicinal product related to any dose should be considered adverse drug reaction. According to FDA, over dose is prime cause of ADR. ** त स णर षध नन व र ध र स त नन ऩ र ष बलमभ सम क ष र व दध र त व र धधबल दधधक अस त ननबल दधधक ऩ र षबल दधधक ह नम भ र दत त तम ऩशम र व र धध व र धधमन र म हस त न त अज ण व ष टभ र ऩच छ र त नल ननम र मद अन हस त न त अककस त ञ चत कर नत तस मथत समम व ववदध यथत स स ३९/१० ** U.S. Food and Drug Administration. /scripts/cdrh/cfdocs/cfcfr/ CFR Search.cfm?CFR Part=314

9 अनतम प रर क तरत क र त व व ध न गद न क ल ब र रर श षनतभमर क र शर म ह नतस रक न अनतम ऩ न स द ष प रक ऩणभमच छ र स त न त क शल च व १/७ (Guna) Quantitative (Dravya) Qualitative Guggulu वप र नन (Karma) Functional Overdose Administration of paste of Operculina turpethum along with Ichhabhedi ras causes drastic purgation. (ADR reported by KLE Ayurveda hospital Belgaum, Karnataka. India. 2010).

10 u ckys ofro`)s kq jksfxj.khxfhkzj.khz kq pa u pkfr{kh.kxk=s kq ;{ey{e;qrs u paa u dzksf/krs u p HkzkUrs g`nksczy;s fo ks kr%a orlukhkfo ka os % izk; kks u iz;kst;sraa j0 r0 24 /

11 Irrational use of drugs Irrational prescription of drugs could lead to unintended drug event. Possibly, these may interact with pathological condition. Special emphasis should be given on factors which need to be analyzed before prescribing drug. Factors to be considered द ष र द श बल क ल अनल प रक नत र सत स त म र तथ ह र अ रथ र शच प रथस त न ध : xéô qééxéô qéç सम ष द ष षध ननर ऩण र त त धचककत स र न च रखलनत ज त धचत ऩ र ष ऩ र ष क ष र स eléårééå भ षग त तम

12 Specific to Prakriti ऱश न --- न न र च छ ल स त ष मक व र ध ऩ स त त तक न प रर जर त क र शर ऩ persons belongs to different Prakriti have different rate of drug metabolism which associated with DME (drug metabolizing enzyme) polymorphism Season and time specific Specific contra indications Disease specific दथह तनदथघशरद न व ऩ जजतमथर द कम प र न ज र हद र प न रन न भ र ङ ग म थ नम क र धप र तव र र म न कष र र शच व ज र त च स

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14 mééuxéïmü réuééléï xrééšéæwûéuéå eéliéñléézéléè cééæwûéuè MüOÒûMüÎxiÉ üè iéï hééåwhééå SÏmÉlÉÉå sébéñè Mæü ÌlÉ वऩत तलरर वऩ वऩत तप रक ऩम ण न र स म नरर Í ÉmÉëÇ वऩत त méëmüéåméqéémé±liéå च व ७/१७ 14

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16 incompatible drugs/diet Unwholesome (Ahita) drugs are not suitable for therapeutic purpose, and administration of such drugs may induce the failure of treatment which lead to unintended drug event. Ayurveda clearly defines that certain diet and its combinations, which interrupts the metabolism. nsg/kkrqizr;uhdhkwrkfu nzo;kf.k nsg/kkrqfhkfozjks/keki Urs] ijlijxq.kfo#)kfu dkfufpr~ dkfufprla;ksxkkrlaldkjknijkf.k ns kdkyek=kfnfhk pkijkf.k rfkk LoHkkoknijkf.kAA p0 fo0 Incompatibility with: Constitution (Prakriti) Place or geographical Location (Desha) Time / Season (Kala) Strength (Bala)

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18 Panchakarma and ADR.. The term ADR includes any unintended response from drug or materials used to diagnose or treat. Edwards RI et al During Panchakarma therapy, many rules and precautionary measures are listed in Ayurveda. These are termed as inadequate (Ayoga), excess administration of therapy (Atiyoga), Contraindications (Anarha) and Complications (Vyapad) while carrying out these procedures. Such consequences are mostly because of faulty preparation of drug and improper assessment of patient resulting in failure of treatment or by iatrogenic.

19 Improper collection, processing and preparation of drug Druginduced Iatrogenic drug with respect to Improper patient examination and wrong selection of pathology, complications Materialistic causes Faulty preparation of instruments like defective basti yantra. ADR related to Panchakarma Patient related Improper execution of treatment, faithless patient and improper pursue of diet restriction

20 Mineral drugs and ADR v kq)a rkezek;q?ua dkfuroh;zcykige~a okfurewpnkzhkzeksrdysna dq Ba kwya djksfr rr~aa mrdysnhksnhkzenkgeksgklrkezl; nks kk% [kyq nq/kzjklrsa fo kks/kukrf}xrlonks ka lq/kklea L;knzloh;Zikds*AA j0 j0 l0 5@47&48 Substan dard/ Impure drug Over dose अततमथत रमकथऱ अल ऩ त ल यव य रभथववतम असम यक स स क त ज र ण व यथऩद य त तद षधम ध र वम Lack of textual knowledge Diet restrict ions ब हत बबल क ष म णड ग र क र ल लकम म ष मस र ननष ऩ क लत थ सष ऩ नतलम क रर च गर व ष टस त म त क ष ण ष ण च श त र ज त र र स ११/१२५

21 Prevention DRUG GCP and GMP (Good collection and manufacturing Practices) Identification of raw drugs Collection practices Method of processing and storage Method of preparation. Purifications of raw materials Standardization of raw material to finish product GCP (Good Clinical Practices) Rogi pareeksha Roga pareeksha Anupana Matra Aushadha sevana kala Pathya DISEASE

22 Conclusion Adverse Drug Reactions are the integral part of drug Pharmacology There is no such thing as a safe drug. One should be cautious while handling a drug. It totally depends on the treating physicians to trade-off between the benefits and the potential risk. This risk can be considerably reduced by use of good quality medications and following various guidelines and instructions mentioned in Ayurveda classics related to administration of drugs. ववज नथतथ शथससतथ य क तथ प रधथन सभषगत र त

23 "Prevention of disease and drug related adverse reactions must become the goal of every physician. kéqééïjéï MüÉqÉ qééå ÉÉhÉÉÇ AÉUÉåarÉÇ MüÉUhÉÇ réiéè iéxqééséuéåaréséléålé léuéå péuéìié xéuéïsè HAPPY DOCTORS DAY